NZ751788B2 - Expandable body device and method of use - Google Patents
Expandable body device and method of use Download PDFInfo
- Publication number
- NZ751788B2 NZ751788B2 NZ751788A NZ75178814A NZ751788B2 NZ 751788 B2 NZ751788 B2 NZ 751788B2 NZ 751788 A NZ751788 A NZ 751788A NZ 75178814 A NZ75178814 A NZ 75178814A NZ 751788 B2 NZ751788 B2 NZ 751788B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- expandable body
- aneurysm
- expanded
- catheter
- neck
- Prior art date
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- 229910052726 zirconium Inorganic materials 0.000 description 1
Abstract
Disclosed herein are medical devices comprising (i) an expandable body configured for location in a saccular aneurysm defined by an inner wall surface of the aneurysm, the expandable body further comprising: a main body further comprising: a proximal neck; a proximal region and a distal region; a distal neck wherein the proximal neck is joined to the proximal region, the proximal region is joined to the distal region, and the distal region is joined to the distal neck; and a wall extending generally continuously through the proximal neck, proximal region, distal region, and distal neck to define an exterior surface of the expandable body and an interior surface of the expandable body, the interior surface defining an interior volume of the expandable body; wherein the expandable body is configured to assume a single lobed shape with expansion; wherein, when expanded, the expandable body is further defined by a first axis and a second axis transverse to the first axis, the first axis extending between the proximal and distal necks; wherein, when expanded, the proximal region and the distal region meet where the expandable body has the largest diameter as measured parallel to the second axis; and wherein, when expanded, the expandable body is configured to reduce the flow of blood into the aneurysm subsequent to the expanded expandable body being located in the biological space; and (ii) a catheter delivery device comprising a longitudinally extending body comprising a proximal end and a distal end generally opposite the proximal end, the distal end of the catheter delivery device being operably coupled with the expandable body. istal neck wherein the proximal neck is joined to the proximal region, the proximal region is joined to the distal region, and the distal region is joined to the distal neck; and a wall extending generally continuously through the proximal neck, proximal region, distal region, and distal neck to define an exterior surface of the expandable body and an interior surface of the expandable body, the interior surface defining an interior volume of the expandable body; wherein the expandable body is configured to assume a single lobed shape with expansion; wherein, when expanded, the expandable body is further defined by a first axis and a second axis transverse to the first axis, the first axis extending between the proximal and distal necks; wherein, when expanded, the proximal region and the distal region meet where the expandable body has the largest diameter as measured parallel to the second axis; and wherein, when expanded, the expandable body is configured to reduce the flow of blood into the aneurysm subsequent to the expanded expandable body being located in the biological space; and (ii) a catheter delivery device comprising a longitudinally extending body comprising a proximal end and a distal end generally opposite the proximal end, the distal end of the catheter delivery device being operably coupled with the expandable body.
Description
EXPANDABLE BODY DEVICE AND METHOD OF USE
CROSS REFERENCE TO RELATED APPLICATIONS
The present application claims priority to: U.S. Provisional Patent
application 61/793,737, which was filed on March 15, 2013, entitled “Expandable Body
Device and Method of Use,” the entire contents of which are incorporated herein by
nce in its entirety.
FIELD OF THE PRESENT SURE
The present disclosure relates to devices and s including an
expandable body and a delivery catheter for the ent of saccular aneurysms of the
vascular system or the occlusion of blood vessel segments or other biological conduits,
where the expandable body ultimately remains in the aneurysm, blood vessel segment,
or ical conduit segment in an expanded state. Further, the present disclosure
relates to methods and systems for delivering and positioning various embodiments of
the expandable body, which are dimensioned and configured to fill and/or seal at least a
portion of the saccular aneurysm, blood vessel t, or biological conduit segment
such that the expandable body remains in place in an expanded state while the delivery
catheter is removed from the patient’s body. The present disclosure also relates to
devices, systems, and methods for treating saccular aneurysms wherein the
expandable body may be deployed in combination with one or more coiled wires that
contact both the wall of the aneurysm and the expandable body and exert force on the
able body to aid in sealing the aneurysm neck.
BACKGROUND OF THE PRESENT DISCLOSURE
An aneurysm is an abnormal outward bulging of a blood vessel that
can occur anywhere in the body. This bulge weakens the blood vessel wall, making it
tible to rupture, which can result in bleeding or hage. Aneurysms are
common in the arterial circulation of the brain, where they are known as cerebral or
intracranial aneurysms. When cerebral aneurysms rupture, this often leads to a
hemorrhagic stroke, brain damage, and sometimes death. Cerebral aneurysms are a
common condition, affecting an estimated 2% of the adult population. Approximately
90% of cerebral aneurysms are saccular with a rounded, sac, or pouch-like shape.
lnvasive surgery is the traditional mode of treatment, with the surgery involving opening
the skull and sealing the aneurysms by placing a small surgical clip on the outside of the
neck or body of the aneurysm, thereby limiting blood flow into the aneurysm sac.
atively, minimally invasive, catheter-based, endovascular
ents have been used wherein a series of small metal coiled wires s”) are
used to fill aneurysm sacs, blood vessel segments, or biological conduit ts to
effect occlusion. In order to occlude an aneurysm or blood vessel with coils, a physician
inserts a catheter into a lumen of the vascular system and maneuvers the catheter tip to
the location where occlusion is desired. With the catheter tip in position, the physician
passes the coils through the catheter into the lumen or inner cavity of the sm,
blood vessel segment, or biological conduit segment.
gh ive, coiling of saccular cerebral aneurysms has
drawbacks. First, coil ent is difficult to control, often resulting in coil protrusion
into the parent vessel or coil ion to non-target locations. Second, coils only
partially fill and occlude the aneurysm sac. The accumulation of thrombus and s
tissue is required to seal the aneurysm, a s that often takes weeks to months to
occur and is sometimes incomplete, which can reduce the effectiveness of coils in the
treatment of acute aneurysm rupture with subarachnoid hage. Even when the
use of coils is lly effective, recanalization of the aneurysm, blood vessel, or
biological conduit is a common occurrence, resulting in a return of blood flow to the
aneurysm and increasing the risk rupture over time. Incomplete filling of saccular
aneurysms with coils is especially common in the neck region of saccular aneurysms,
where coil density can be low and blood flow rates high. Third, numerous coils are
usually required to treat the aneurysm, resulting in high costs and long treatment times.
Fourth, coils are susceptible to compaction, further exposing the aneurysm neck and
y contributing to the high rate of aneurysm recurrence.
More recently, traditional tubular stents have been adapted for the
treatment of al aneurysms. These stents are placed on catheter delivery devices
and positioned in the parent vessel adjacent to the aneurysm. These stents are then
expanded in the parent vessel with the delivery device, followed by removal of the
delivery device. The expanded metal stent acts to reduce blood flow into the aneurysm
sac and promote aneurysm osis. Although effective, the use of these “flow
diverting” stents has drawbacks. First, the stents may cover and divert blood flow away
from ant arterial branches adjacent to the aneurysm, sometimes resulting in
ischemia and stroke — a problem ally seen with the treatment of bifurcation
aneurysms. Second, these stents are a source of thrombus and intimal hyperplasia
formation in the parent vessel, which can result in narrowing in the parent vessel lumen,
ia, and stroke.
In other clinical situations, patients can benefit from the occlusion of
certain artery or vein segments. al settings where endovascular vessel occlusion
is beneficial include reducing bleeding from an injured vessel, ng blood flow to
tumors, and rerouting the path of blood in the vascular system for other purposes such
as to reduce blood flow to vascular anomalies and malformations. Minimally ve,
catheter-based, endovascular treatments have been developed to occlude blood vessel
segments. Endovascular medical devices for blood vessel ion include balloon
catheters wherein the balloon can be inflated to fill the lumen of a blood vessel segment
and detached from the catheter. There are two major cks to the use of
detachable balloon ers for blood vessel occlusion. First, the balloons are made of
polymers that generally resist tissue incorporation. This limits fixation of the s
where they are placed and increases the risk of migration. Second, the balloons are
configured with elastic walls, which are expanded with pressurization, and valves
designed to maintain that pressure after detachment. Unfortunately, there is a
substantial rate of balloon and valve failure, resulting in deflation. Without tissue
incorporation, balloon deflation can lead to blood vessel or biological conduit
recanalization or balloon migration and occlusion of rget vessel segments.
More recently, endovascular medical devices for blood vessel
occlusion have been developed that e basket structures that are used to fill a
portion of the lumen of a blood vessel segment to induce thrombosis and occlusion of
the blood vessel segment. Although only a single basket structure is y required to
e a blood vessel segment, and the devices are generally easier to control, these
devices only partially fill the blood vessel and require the accumulation of us and
fibrous tissue to occlude the blood . As with coils, this process takes weeks to
occur and is sometimes incomplete, often resulting in incomplete occlusion or
recanalization and a failed treatment.
Therefore, there remains a need for l devices, systems, and
methods for treating ar aneurysms, including al aneurysms, which result in
a more effective and complete reduction of blood flow to saccular aneurysms that is
more effective in sealing the neck, and more durable and permanent. It is further
desired to have medical devices, systems, and methods that reduce the flow of blood
into saccular aneurysms and seals the aneurysm neck more quickly. y, it is
desired to have medical devices, systems, and methods for treating saccular
aneurysms that can be used more easily and in less time, with a lower risk of
complications, and at a lower cost when compared with existing treatments.
There also remains a need for catheter-based medical devices,
systems, and methods for the occlusion of segments of blood vessel segments and
other biological conduits that are simple to perform, result in a rapid, controlled, and
complete occlusion, have a low risk of recanalization, device migration, or other
complications, and can be purchased at a able cost.
SUMMARY OF THE PRESENT DISCLOSURE
Disclosed herein are medical systems and s for the treatment of
saccular aneurysms using an able body or structure or one or more expandable
bodies or structures in combination to occlude saccular aneurysms. Also disclosed are
medical systems and devices for the occlusion or blockage of blood vessel segments,
including arteries, veins, other vascular conduits, and other biological conduits using an
expandable body or structure, or one or more expandable bodies or structures in
ation. The expandable body or bodies may be configured for use as a balloon, a
2014/030869
ent, a blockstent, a self-expanding coil of wire, or other expandable construction.
The terms “expandable body”, “expandable structure”, “expandable balloon”, “ballstent”,
and stent”, as used herein, refer to an expandable body having a single-layered or
multi-layered construction and wherein the expandable body may be first introduced in a
non-expanded state into a patient using a delivery device; second, negotiated in the
non-expanded state through the cardiovascular system of the patient to a target
treatment site (i.e., implantation site); third, expanded at the target ent site into an
expanded state; and, fourth, detached from the delivery device to remain in the t’s
body in an expanded configuration at the target or treatment site. Also disclosed herein
are methods of manufacturing and methods of using the l devices and medical
systems.
A medical system disclosed herein may be used to fill a biological
space of a patient. Such a medical system es a single-lobed metallic expandable
body and delivery device. Such a medical system may also include one or more
additional expandable bodies, including coiled wires that can be placed immediately
adjacent to the single-lobed expandable body. Filling of a biological space includes
ocdugonofafleastaponbnofalumenofarupuwedornonwupuwedsacmflar
sm or a lumen of a blood vessel segment, including arteries and veins, or a
lumen of another type of biological conduit.
The single-lobed metallic expandable body includes a distal region, a
al region generally opposite the distal region, and ally an intermediate
region transitioning from the distal region to the proximal . A center axis extends
proximal-distal between the proximal region and distal region of the single-lobed
metallic expandable body. A wall of the single-lobed metallic expandable body extends
generally continuously through from the proximal , optionally through the
intermediate region, to the distal region to define an exterior surface of the expandable
body and an interior surface of the expandable body. The interior surface defines an
interior volume of the expandable body. The expandable body is configured to expand
from a deliverable (i.e., collapsed or non-expanded) configuration to an expanded
configuration.
In various embodiments, the expandable body includes a proximal
region and distal region separated by an intermediate region that forms the unitary
construct of the expandable body. The expandable body may further be defined by a
first axis and a second axis transverse to the first axis. The first axis extends between a
proximal neck and a distal neck of the expandable body. In one aspect, the shape of
the intermediate region may be described and d by an arc parallel to the first axis.
In various embodiments, the width or length of the expandable body along the second
axis is greater than the height or length of the expandable body along the first axis. In
some embodiments, when expanded, a maximum radius of the distal region, parallel to
the second axis, is less than or equal to a maximum radius of the proximal region
parallel to the second axis. In some ments, when expanded, a maximum radius
of the distal , el to the first axis, is less than or equal to a maximum radius of
the proximal region parallel to the first axis.
In various other embodiments, the expandable bodies may also be
defined and described as having a generally hemispherical proximal region affixed to a
generally herical distal region. Hemispheroids formed by each region may be
further defined by a semi-major axis and semi-minor axis that align with the first axis or
the second axis. Each region has a ponding neck and may independently define
an oblate hemispheroid, a prolate hemispheroid, or a hemisphere.
The delivery device has a udinally extending body that includes a
proximal end and a distal end generally opposite the proximal end. The distal end of
the delivery device is operably coupled to the proximal neck of the expandable body. In
some embodiments, the distal end of the delivery device is also operably d to the
distal neck of the expandable body. In one embodiment, when the expandable body is
in the deliverable configuration, the wall assumes a pleated configuration having a
plurality of pleats folded over in a clockwise direction relative to the first or center axis,
or, alternately, in a counter-clockwise ion relative to the first or center axis to form
a folded-over region of the expandable body. Conversely, when the expandable body is
in the ed configuration, the plurality of pleats is not folded over and the pleated
uration substantially ceases to exist.
In one embodiment, the system or medical system includes a
detachment system having an ical t partially supported on the delivery device
and configured to decouple an expandable body from a distal end of the delivery device
by electrolysis.
Methods for filling at least a portion of a biological space of a patient
are also sed herein. One method includes providing a -lobed metallic
expandable body configured to expand from a deliverable configuration to an expanded
configuration. The expandable body is uced to the biological space of the patient
in a deliverable configuration via a delivery device having a distal end operably d
to a proximal neck, proximal region, or distal neck of the expandable body. A fluid
medium can be delivered into the or volume of the expandable body via the
delivery device to inflate or expand the expandable body, causing it to assume an
expanded configuration. After expansion, the expandable body is detached from the
delivery device. In some ments, the method includes using a detachment
system having an electrical circuit partially supported on the delivery device to decouple
the expandable body from a distal end of the delivery device by electrolysis. In some
embodiment a portion of the delivery , including a portion of the proximal neck,
undergoes electrolysis prior to detachment. In some embodiments, the portion of the
proximal neck that undergoes electrolysis is ring shaped.
Methods for manufacturing a device or system for filling a ical
space of a patient are also disclosed herein. One method includes manufacturing a
single-lobed metallic expandable body having a distal region, a proximal region
generally opposite the distal region, and an optional intermediate region transitioning
from the distal region to the al region. A center or first axis extends between the
proximal neck and the distal neck of the single lobed metallic expandable body. A wall
of the single-lobed metallic expandable body extends generally continuously from the
proximal region through the intermediate region, and to the proximal region to define an
exterior surface of the expandable body and an interior surface of the expandable body.
The interior surface defines an or volume of the expandable body. The method
also es g orjoining all or a portion of one or two neck segments to the
expandable body. The neck segments may be joined during an electroforming process
to form the expandable body.
The s also include manufacturing a delivery device having a
longitudinally extending body that includes a proximal end and a distal end generally
opposite the proximal end, ly coupling the distal end of the delivery device to the
expandable body, including to the proximal neck or proximal region of the expandable
body. The methods of manufacturing also include forming the wall of the expandable
body into a pleated configuration. The pleated configuration includes a plurality of
pleats folded over in a clockwise ion relative to the first or center axis, or
alternately, a counter-clockwise direction relative to the first or center axis to form a
folded-over region of the able body.
Another method of manufacturing a system for filling a biological space
of a patient includes coupling a stainless steel ring to a proximal end of a icial
mandrel, depositing a metal layer over the sacrificial mandrel and at least over a portion
of the stainless steel ring or tube, and ating the sacrificial mandrel to leave behind
the metal layer in the form of a hollow body having the shape of the sacrificial mandrel,
which can be fashioned into an expandable body. This ment of a method of
manufacturing includes a method wherein the metal is deposited by electroforming, and
a method wherein the metal deposited is gold. The stainless steel ring is therefore
joined to and extending from a al region of the hollow body, forming a neck,
including forming a proximal neck. The stainless steel ring may also be added by
welding a separate segment to the neck or main body of the expandable body, the main
body defined as comprising the proximal region and the distal region, and ally the
intermediate region. In certain embodiments, a stainless steel ring or tube is coupled to
a delivery , and configured wherein the ring or tube can be d by
electrolysis.
The method can include applying an electrical insulation al to an
exterior e and an interior surface of the expandable body and an exterior surface
or interior surface of the stainless steel ring and creating an anode by rendering a
portion of the exterior surface of the region of the neck composed of the stainless steel
ring free of the electrical insulation material. The method further includes coupling at
least a portion of the stainless steel ring to a distal end of a delivery device and
electrically coupling an electrolysis system to the stainless steel ring to form a potential
anode h a conduction path that travels through the delivery device. The method
also includes affixing one or more end caps or nose cones to the necks of the
expandable body, or to the distal end of the delivery catheter. The end caps or nose
cones may comprise a ric material. In addition, a polymer sheath or coating may
be ed to the expandable body and end caps or nose cones, such that the polymer
sheath encapsulates the expandable body when in a folded, wrapped, or compressed
delivery configuration.
In the various embodiments of the devices, systems and methods
described above, the walls of the expandable body can include at least one metal layer
having a thickness ranging between approximately 5 and 50 pm. In one e, the
metal layer of the proximal, intermediate, and distal regions may include gold or
platinum. The wall of the able body may also include an inner layer of a non-
metallic coating extending over an inner surface of the metal layer and / or an outer
layer of a non-metallic g extending over an outer surface of the metal layer. The
non-metallic coating may be an electrical insulation material, including, for example,
ne. For example, an inner layer and outer layer of Parylene may coat the gold or
platinum metal layer.
A surface of the metal layer may include rounded, pebbled, or granular
surface structures that have a surface height of approximately 0.1 pm to approximately
pm. The outer surface of the metal layer may include generally tubular protrusions.
In one embodiment, some of the generally tubular sions are branched. In another
embodiment, some are joined on both ends to the metal layer to form loops.
The metal layer of the expandable body may be produced by
electroforming on a mandrel, wherein ally all or a portion of the mandrel is
sacrificial. Portions of the mandrel may be formed of sacrificial um components,
as well as non-sacrificial components made of other metals, such as stainless steel,
zinc, ium, or . The mandrel may have a surface finish of no more than
approximately 0.1 pm Rt(i.e. maximum peak-to-valley height).
Alternately, the mandrel may have a pleated outer surface that
lly replicates a pleated configuration of the expandable body that is intermediate
in shape between the deliverable configuration and the expanded configuration. A non-
sacrificial stainless steel mandrel component may e a surface layer of gold or
platinum that extends over at least a portion of one of an inner surface or an outer
surface of the non-sacrificial mandrel component.
In various ments, the expandable body may undergo one or
more annealing processes. The expandable body may be ed before and after
being folded into the deliverable configuration. r, the expandable body may
undergo an annealing process while comprising a non-metallic g.
The wall of the expandable body may include pores that may extend
completely through the thickness of the wall from the interior to the exterior surface.
The pores range from 0.1 to 500 pm in diameter. As such, the expandable body may
be inflated by a fluid supply device in fluid communication with the interior volume of the
expandable body via the delivery device. The fluid supply device is configured to
provide a supply fluid flow rate to the interior volume that exceeds an escape fluid flow
rate from a plurality of pores at a fluid delivery pressure. In one embodiment, at the
time of expansion of the expandable body the pores are filled with a material that is
biodegradable or bioerodible, such that the pores open some period of time after
ion in vivo.
When in the delivery or rable configuration, the -over
region of the expandable body may define a wire-receiving channel. In one
embodiment, no portion of the delivery device or delivery catheter is found within the
folded-over region of the expandable body. In another embodiment, a portion of the
delivery device or delivery catheter is found within the folded-over region of the
expandable body. Each pleat includes a ridge line extending proximal-distal and
radially away from the center axis and each pleat is separated from any immediately
adjacent pleat by an interposed trough extending proximal-distal, such that the d
configuration has an alternating ridge-trough arrangement. When folded, each pleat is
folded over an immediately adjacent pleat in a ise direction relative to the first or
center axis, or in a r-clockwise direction relative to the first or center axis. In one
embodiment, no n of the delivery device is found within the folded-over region of
the able body. In another embodiment, the folded-over region of the expandable
body may define a channel for receiving a guide wire. In another embodiment, a portion
of the delivery device or delivery catheter is found within the -over region of the
able body.
In various embodiments, the expandable body is ed or expanded
to achieve the expanded configuration. The expandable body is inflated or expanded
via the delivery of a fluid medium to the interior volume of the expandable body. The
fluid medium typically includes a liquid or gas. In various embodiments, during
expansion, pressure within the expandable body is 5 atmospheres (atm) or less. Other
le pressures include 3 atm or less, 2 atm or less, and 1 atm or less.
During expansion or inflation, the pleated configuration and the
plurality of pleats of the able body that are present in the deliverable
configuration are substantially eliminated. When expanded, the expandable body
possesses sufficient strength to maintain itself in the expanded configuration within a
biological space after detachment or separation from the delivery device.
The metallic able body and the delivery device are configured
to allow the interior volume of the expandable body to, optionally, be at least partially
filled with a solid or semi-solid support structure. The support structures include metallic
or polymeric coils or wires, metallic or polymeric expansile structures, beads, balls,
microspheres, a orbable or bioerodible material, or combinations thereof. In one
embodiment, solid or semi-solid material or members not derived from the patient are
not required in the interior volume of the expandable body to cause the able
body to assume or maintain the expanded configuration after separation of the
able body and the delivery device.
When in the expanded configuration, the expandable body may have
an overall shape that is spherical, spheroid, or ellipsoid. In various embodiments, an
expandable body smaller than the biological space to be filled is selected. In various
embodiments, when expanded, the expandable body has a maximal width, , or
diameter parallel to the second axis that is greater than the width of the mouth or
opening into the biological space, such that the expanded form of the expandable body
2014/030869
may reduce the flow of biological fluid into the biological space, or seal the mouth or
opening into the biological space. For example, the expandable body may be used to
seal a saccular sm or at least reduce the flow of blood into a ar aneurysm.
To maintain contact with the mouth or opening of the aneurysm, the expandable body
may be deployed in combination with a coiled wire that fills at least a portion of the
remaining void in the biological space and applies force to the surface of the
able body to maintain its position within the space and maintain continued
contact with the mouth or g of the space. In certain ments the coiled wire
is a form of an expandable body, such as when the coiled wire comprises nitinol or
another self-expanding material. In particular, the coiled wire (or “coil” or “accessory
coil”) is deployed within the void of an sm between the expandable body and the
wall of the aneurysm opposite the mouth or opening from the parent vessel and into the
aneurysm lumen or sac. As used herein, a parent vessel is a vessel from which the
aneurysm has formed. The accessory coil contacts both the wall of the aneurysm and
the expandable body and applies a force to press or hold the expandable body against
the neck or mouth of the aneurysm. The size of the expandable body is selected such
that the expandable body is larger or wider than the neck or mouth of the aneurysm and
cannot be pushed out of the aneurysm and into the parent vessel in a manner that
would occlude more than 50% of the lumen sectional area of the parent vessel.
In one embodiment, the accessory coil can be made with methods and materials that
impart a self-expanding quality to the coil. For example, the accessory coil may be a
spherically-shaped coil comprising nitinol. In other embodiments, the accessory coil
may be of various other shapes, including but not limited to spherical, spheroid,
ellipsoid, or cylindrical configurations. In other embodiments the accessory coil may be
coated with a ric material, such as PTFE, to cushion the coil and increase the
lubricity of the coil in a manner that may reduce trauma to the wall of the aneurysm and
may reduce the force required to push the coil through and out of a coil ry
catheter.
In various aspects, the accessory coil may have a diameter in a range
between approximately 0.002 and 0.012 inches. Preferably, the accessory coil has a
diameter between approximately 0.004 and 0.008 inches. Similarly, the polymer
coating on the ory coil may have a thickness in a range between approximately
0.001 and 0.003 inches. Preferably, the polymer coating has a thickness between
approximately 0.0015 and 0.002 inches. The ory coil may be delivered to the
ical space, such as the lumen of the aneurysm, using a delivery catheter that may
be placed through the guidewire lumen of the ry catheter that is d to the
expandable body. This coil delivery catheter may have an outer diameter in a range
n approximately 0.014 and 0.022 inches, and preferably, an outer diameter
between approximately 0.016 and 0.020 inches. Similarly, the coil delivery catheter
may have an inner diameter in a range between approximately 0.008 and 0.016 inches,
and preferably, an inner diameter between approximately 0.010 and 0.014 inches.
The expandable body may include a proximal and distal neck that each
extends away from the expandable body. In one ment, both the expandable
body and the neck are formed entirely from a malleable metal such as gold or platinum.
In another embodiment, at least a portion of at least one neck comprises stainless steel
that may be subsequently severed via electrolysis, including a stainless steel ring.
The delivery device includes a longitudinally extending body, which
may have the form and function of a catheter, and may have a hydrophilic or lubricious
coating. This coating may also be present on the expandable body. The distal segment
of the udinally extending body is operably coupled to the expandable body,
including to the proximal neck and the al region. The distal segment of the
longitudinally extending body may also be operably coupled to the distal neck. For
example, the distal end of the longitudinally extending body may be received in the neck
at the proximal region of the expandable body, such that the outer surface of the distal
t of the longitudinally extending body is in contact with an inner surface of the
proximal neck of the able body. In another example, the distal segment of the
longitudinally ing body ates near a proximal edge of a ring-shaped region
of exposed metal in the neck of the expandable body. In another example, the distal
segment of the longitudinally extending body extends through the expandable body and
is in contact with an inner surface of the distal neck of the able body. In another
example, the distal segment of the longitudinally extending body extends through the
expandable body and through the distal neck of the expandable body.
The various systems and methods may e or use an olysis
system configured to deliver an electrical current to the expandable body, including to
an exposed metal surface on a neck, including the proximal neck. In various
embodiments the electrical t comprises a constant current, a constant voltage, or
a square-wave voltage. When the longitudinally extending body or delivery catheter is
coupled to the expandable body, the delivery of the electrical current can result in
tion or detachment of the delivery catheter from the able body. The
separation can occur in a circumferential or ring-shaped non-coated or exposed metal
surface region of the neck formed of ess steel or gold and exposed by, for
example, laser etching. During electrolysis, the circumferential non-coated or exposed
metal surface region of the neck acts as an anode. When delivering a square-wave
voltage, the voltage of the anode is modulated based on a comparison between the
voltage of the anode and the voltage of a reference electrode supported on the delivery
device or residing external to the delivery device, such as with a needle or electrode
pad residing on or in the patient, or an electrode residing on the body of the delivery
catheter.
One method of manufacturing the expandable body includes: a)
providing a sacrificial mandrel sing a pleated outer surface; b) depositing a metal
layer over the sacrificial mandrel; c) removing the sacrificial mandrel and leaving behind
the metal layer in the form of a hollow pleated body; d) g with a tallic
material an interior surface and / or an exterior surface of metal layer of the hollow
pleated body; and e) folding the hollow pleated body to further increase the extent to
which the hollow pleated body is pleated, the g comprising folding over a plurality
of pleats in a clockwise direction relative to a center axis of the hollow pleated body, or
a r-clockwise direction relative to the center axis.
The portion of the olysis system supported on the delivery device
includes one or more conductors embedded on or in the wall of the delivery catheter
that act as electrical tors for the electrical system. These conductors may also
simultaneously provide structural reinforcement for the wall of the delivery er.
The conductors are wires, cables, or other electrical conductors that may be routed on
or through the catheter or catheter wall in a variety of configurations including a spiral,
braided, or ht configuration. One of the conductors is in electrical communication
with a portion of the expandable body that can function as an anode, such as at or near
a circumferential region of the neck having an d metal surface, while r of
the conductors is in electrical communication with a structure supported on the delivery
device that can on as a cathode, such as a platinum metal electrode or ring. In
one embodiment, one of the conductors is in electrical communication with a structure
supported on the delivery device that can on as a reference electrode.
The present application is d to PCT International Patent
Application No. PCT/US12/47072, which was filed on July 17, 2012, entitled
“Expandable Body Device and Method of Use”; PCT International Patent Application
No. PCT/US12/21620, which was filed on January 17, 2012, entitled “Detachable Metal
Balloon Delivery Device and Method”; PCT International Patent Application No.
12/21621, which was filed on January 17, 2012, entitled “Ballstent Device and
Methods of Use,” PCT International Patent Application No. PCT/US12/00030, which
was filed on January 17, 2012, ed “Blockstent Device and Methods of Use,” and
US. Provisional ation No. 61/433,305 (“the ‘305 Application) entitled “Detachable
Metal Balloon Delivery Device and Method,” filed on January 17, 2011. Each of the
above-listed patent applications is commonly-owned, was commonly owned by the
same inventive entity at the time of filing, and is orated herein by reference in its
entirety.
DESCRIPTION OF FIGURES
FIGS. 1A-D are planar views of embodiments of an expandable body.
is a perspective view of an embodiment of an expandable
body.
FIGS. 2B-C are a partial interior view and a cross-sectional view,
respectively, of an embodiment of the expandable body of .
FIGS. 2D-E are a perspective view and a cross-sectional view,
respectively, of an embodiment of an expandable body.
is a plan view of an embodiment of an expandable body.
is a partial interior view of an ment of an expandable
body of .
FIGS. 2H-K are close-up cross-sectional views of an embodiment of
the expandable body of .
is a perspective view of an embodiment of an expandable
body.
is a plan view of an embodiment of the expandable body of
.
is a cross-sectional view of an embodiment of the expandable
body of .
is a close-up cross-sectional view of an embodiment of an
embodiment of the expandable body of .
is a cross-sectional view illustrating a delivery device and coil
traversing the interior of the expandable body of .
is a partial interior view illustrating a delivery device sing
the interior of the expandable body of .
FIGS. 3A-B are a cross-sectional view and a close-up sectional
view, respectively, of an embodiment of an expandable body.
FIGS. 4A-B are a planar view and a close-up cross-sectional view,
respectively, of an embodiment of an expandable body.
FIGS. 5A-B are a planar view and a close-up cross-sectional view,
respectively, of an electrolysis neck segment for an embodiment of an expandable
body.
FIGS. 6A-B are a perspective view and a cross-sectional view,
respectively, of an embodiment of an able body and ry device.
FIGS. 6C-D are a perspective view and a cross-sectional view,
respectively, of an ment of an expandable body.
is perspective view of an embodiment of a dual catheter delivery
FIGS. 8A-F are planar views of various configurations for embodiments
of an expandable body.
FIGS. 8G-V are views of various configurations for embodiments of an
expandable body.
is a plan view of an embodiment of a medical device.
FIGS. 10A-B are plan views of an embodiment ofa medical device.
FIGS. 11A-F are views of an embodiment of the medical device
illustrating a sequence of steps associated with the delivery of the expandable body to
an aneurysm and deployment.
FIGS. 12A-B are ctive views of an embodiment of an ory
coil.
is a plan view of an embodiment ofa medical device.
FIGS. 14A-B are plan views of an embodiment ofa medical device.
FIGS. 15A-F are views of an ment of the medical device
illustrating a sequence of steps associated with the delivery of the expandable body to
an aneurysm and deployment.
FIGS. 16A-D are hemispherical sectional views taken along a
diameter of embodiments of the expandable body.
E is a longitudinal section of the expandable body
supported on a distal end of a delivery catheter, wherein the able body is
cal and may be employed as an embodiment of a ballstent.
F is a partial cross-section through the wall of the ballstent of
E.
G is a longitudinal cross-section of the expandable body
supported on a distal end of a delivery catheter, wherein the expandable body is
cylindrical with hemispherical ends and may be employed as an embodiment of a
ballstent or blockstent.
H is a partial cross-section through the wall of the able
body of G.
I is a longitudinal cross-section of the expandable body
ted on a distal end of a delivery catheter, wherein the expandable body is
spherical and may be employed as an embodiment of a ballstent.
J is a partial cross-section through the wall of the ballstent of
FK3.16L
K is a longitudinal cross-section of the expandable body
supported on a distal end of a delivery catheter, wherein the expandable body is
cylindrical with hemispherical ends and may be employed as an ment of a
ballstent or blockstent.
L is a partial cross-section through the wall of the expandable
body of K.
FIGS. 17A-B are views of the able body deployed in a
bifurcation aneurysm with an accessory coil according to one embodiment.
0 is a plan view of the expandable body deployed in a
ation aneurysm after the insertion of an accessory coil that is positioned both
within the expandable body and the void of the biological space.
D is a plan view of the expandable body ed in a
bifurcation aneurysm after the ion of a magnetic internal support structure and an
external ic coil.
E is a plan view of the expandable body after the insertion of an
internal support ure.
F is a plan view of an embodiment of the expandable body,
wherein the shape of the expanded body is being changed by applying an external force
using a balloon catheter.
G is a plan view of the expandable body after insertion in a
ation aneurysm.
FIGS. 18A-E are plan views of embodiments of an expandable body
with a porous surface layer facilitating tissue ingrowths in an aneurysm.
F is a plan view of the expandable body after the insertion of an
accessory coil that contacts and secures a thrombus within a bifurcation aneurysm.
FIGS. 18G-H are plan views of embodiments of an expandable body
with external surface projections for ing the expanded body to the surrounding
fissues.
2014/030869
A is a perspective view of an embodiment of an expandable
body as compressed against a delivery catheter.
B is an end view of an embodiment of a compressed
expandable body.
0 is an end view of an embodiment of a compressed
expandable body that defines an off-center channel.
D is an end view of an embodiment of a compressed
expandable body.
FIGS. 20A-B are transverse cross-sections of embodiments of the
delivery catheter of the medical device.
FIGS. 21A is a plan view of an ment of the medical device with
a lumen configured to accept a guide catheter, rather than a guide wire.
B is a transverse cross section of the device as taken along
section line A-A in A.
is a perspective view of an ement for inflating or
deflating an expandable body.
A is a plan view of an embodiment of the l device
wherein the able body is attached to the delivery catheter with an adhesive and
separated from the delivery catheter by electrolysis of a portion of the neck of the
expandable body.
FIGS. 23B-F are transverse cross-sectional and plan views of various
delivery catheters.
G is a plan view of a catheter supporting one or more electrode
rings.
FIGS. 23H-l are partial cross-section and perspective views of an
able body attached to a ry device.
A illustrates various dimensions for an expandable body having
a cylindrical intermediate portion and herical ends.
FIGS. 24B-C illustrate various dimensions for a neck region of an
expandable body.
FIGS. 25A-C depict a sequence for electroforming an expandable body
on a l.
depicts an embodiment of a mandrel for electroforming a metal
expandable body.
depicts another embodiment of a mandrel for electroforming a
metal expandable body.
is a partial cross-section of metal expandable body produced
by electroforming.
FIGS. 29A-D are photographs of various embodiments of mandrel
models and metal expandable bodies formed thereon.
E shows an external surface of a metal expandable body
ing to one embodiment.
FIGS. 30A-B respectively depict coatings on an exterior surface and an
interior surface of a cal ment of an expandable body.
FIGS. 3OC-F are various plan views and cross-sections depicting a
region of d metal e wherein the metal expanded body is detached from the
delivery er by electrolysis.
FIGS. 31A-B are plan views of embodiments of the medical devices for
delivering various embodiments of the expandable body.
A is a cross-sectional view of a hub for use with a medical
device wherein electrolytic detachment of the expanded body is performed by passing
an electrical current into the medical device.
FIGS. 32B-C are partial see-through views of a hub for use with a
l device.
is a top plan and side plan view of a handheld controller for
use with a medical device wherein detachment of the expanded body is performed by
passing an electrical current into the medical device.
FIGS. 34-36 are flowcharts illustrating the steps for manufacturing the
expandable body, a delivery catheter, and a medical kit containing a medical device,
respectively.
FIGS. 37A-D are illustrations of a process for surgically constructing a
saccular aneurysm on a newly created carotid artery terminal bifurcation as performed
during clinical testing of an embodiment of the expandable body.
is an angiogram of a saccular aneurysm acquired during
clinical testing of an embodiment of the expandable body.
FIGS. 39A-B are angiograms of occluded saccular sms
acquired during clinical testing of an embodiment of the expandable body.
s a tissue samples ted during clinical testing of an
embodiment of the expandable body.
depicts results of angiography performed during clinical testing
of an embodiment of the expandable body.
depicts tissue samples collected during al testing of an
embodiment of the expandable body.
ED DESCRIPTION
The present disclosure relates to a medical device including a delivery
device and an expandable structure or expandable body. The expandable body is a
thin-walled, hollow metal structure that can be compressed and then ed into a
semi-rigid form that can remain in the body for an extended period. The terms
“expandable body , expanded body , expanded expandable body , able
structure
, expandable balloon , ballstent”, and “blockstent” are all used to be
the hollow metal ure described herein for use in filling a biological space. The
term ded” is generally used to describe an expandable body that is expanded,
and not in the deliverable or delivery configuration. Particular embodiments of the
expandable body may be referred to as a ballstent or blockstent according to structure
and/or use of the body. In one example, the term “ballstent” is used at times to describe
a generally rounded form of the able body and one that can be used for the
treatment of saccular cerebral aneurysms. In another example, the term “blockstent”
can be used at times to describe a generally oblong or cylindrical form the expandable
body, and one that can be used to fill a portion of the lumen of an artery or vein
segment, or a portion of the lumen of a segment of another form of biological conduit.
Specifically, the expandable body, when acting as a ballstent, is configured for use in
filling and occluding saccular aneurysms of blood vessels, ally saccular cerebral
aneurysms and ruptured aneurysms. The expandable body may also be configured as
a blockstent for use in blocking or occluding the lumen of segments of arteries, veins,
and other biological conduits.
The delivery device is configured to deliver a ballstent to an aneurysm
and to provide a pathway, through a hollow cylindrical member or lumen of a cylindrical
member, for a fluid medium to move into the void of the ent expandable body, in
order to expand it and fill at least a n of the volume of the aneurysm sac. The
delivery device can also be configured to r a second able body or other
structures, such as a coiled wire or nitinol coiled wire, to an aneurysm by providing a
pathway through a hollow cylindrical member or lumen of a cylindrical member for the
coiled wire to pass from outside the t into the lumen or cavity of the sm.
The delivery catheter also can be configured to deliver an expandable body in the form
of a blockstent to a blood vessel t and to provide a pathway, through a
cylindrical member or lumen of a rical member, for fluid to move into the central
void of the blockstent expandable body, in order to expand it and fill at least a portion of
the lumen of the blood vessel segment. Expanding the expandable body, as used
herein, can refer to partial or te expansion of the body using a fluid (Le, a ,
gas, gel, or combination thereof) or a solid (Le, a solid body, a lattice, granular
particles, etc., or a combination thereof).
In certain embodiments, the expandable body includes two necks
positioned at opposite ends of the expandable body. For example, one neck may be
located at a proximal end of the expandable body and another neck may be positioned
at the distal end of the expandable body. Optionally, at least one of the necks may be
joined to a ring (such as through a weld), such as a stainless steel ring, that can be
severed by electrolysis after placing the expandable body in a biological space. In this
instance, the main body of the expandable body may comprise a material that is less
susceptible to electrolysis or galvanic corrosion, such as noble metals including but not
limited to gold, while a neck may comprise a material of less relative nobility that is more
susceptible to electrolysis or galvanic corrosion, such as stainless steel. Alternatively,
the body and a neck may comprise materials that are more similar in their susceptibility
to electrolysis or galvanic corrosion and the body and optionally a n of the neck
may be coated with a material that functions as an electrical insulator to limit the
electrolysis or galvanic ion to the neck or the coated n of the neck during
electrolysis. Such electrical insulator could include Parylene. Alternatively, a neck may
comprise a al of less relative nobility that is more tible to electrolysis or
galvanic corrosion, such as stainless steel, and a portion of this material more
susceptible to electrolysis or galvanic corrosion may be coated with additional material
that is less susceptible to electrolysis or galvanic corrosion, such as noble metals
including but not limited to gold, such that electrolysis will be trated in the portion
of the neck where the al of less relative nobility that is more susceptible to
electrolysis or galvanic corrosion, such as ess steel, is d or uncoated.
Each of the necks may include a tip or nose cone to improve the
dynamic profile of the device that reduces resistance during the ement of the
device in a forward or rd direction within an artery, vein, or other biological
conduit. In this manner the tip or nose cone could reduce the risk of injury to the wall of
the artery, vein, or other biological conduit. The tip or nose cone may comprise
polymeric, metallic, or other materials, including als that are biodegradable or
bioerodible. The presence of a tip or nose cone on the expandable body can reduce
friction, reduce trauma caused by a proximal or distal end of the body, and improve
trackability of the device as it is positioned and repositioned. This is especially relevant
when placing the expandable body within an aneurysm, as the dome of an aneurysm is
fragile and susceptible to wall rupture when probed with a sharp or fine-pointed device.
The tip or nose cone may also provide an attachment point for a r wrap that
surrounds the folded, wrapped, or compressed expandable body as the body is
positioned within the patient. The r wrap further increases the trackability of the
body and reduces friction as the expandable body is delivered through the vascular
system. The tip or nosecone may also be placed on the distal portion of a delivery
catheter where it can serve a similar purpose.
The expandable body can be formed by depositing a metal layer over
a mandrel using an electroforming process. During the electroforming process, a metal
ring or structure may be incorporated into the metal layer to create a neck for the
expandable body. This ring or structure may comprise stainless steel, zinc, copper or
gold, or other material susceptible to galvanic corrosion or electrothermal separation.
The mandrel may be a sacrificial l that can be eliminated from the expandable
body after oforming, to leave a hollow metallic structure that is, or can be formed
into, an expandable body.
The hollow metallic able body may undergo one or more
annealing processes. The annealing process may occur before or after a neck segment
that includes stainless steel is welded or otherwise joined to the expandable body. The
interior and exterior surfaces of the metallic expandable body may be coated with a
metallic or non-metallic al that is an ically insulating material, including
polymers such as Parylene. The or and exterior es of the metallic
expandable body may be coated or partially coated with a metallic or non-metallic
material that is less susceptible to electrolysis or galvanic ion, such as noble
metals including but not limited to gold. The metallic expandable body may be
annealed before and after the metallic expandable body has been caused to assume a
deliverable (i.e., collapsed or non-expanded) folded or pleated configuration. The
metallic body may be annealed before or after a g is applied, including gs of
an electrically insulating al.
The metallic expandable body can be folded into a deliverable
configuration for introduction into an aneurysm, an artery or vein segment, or a segment
WO 46001
of another form of biological t. When folded into the deliverable configuration, the
metallic expandable body can be formed into a pleated configuration, having a number
of pleats, which may be d around a central axis of the metallic expandable body.
When used to fill an aneurysm, the catheter delivery device and an
attached ballstent expandable body are advanced into the lumen or cavity of the
aneurysm sac. Similarly, when used to occlude a blood vessel or other biological
conduit, the delivery device and an attached blockstent able body are advanced
into the lumen or void of the vessel or biological conduit. The delivery device can also
deliver a fluid, a solid, or a combination thereof, to the interior void of the expandable
body to expand the body in the lumen of the aneurysm sac or blood vessel segment,
and to help maintain the expansion of the expanded body. The expanded body may be
detached from the delivery device by one or more of a variety of arrangements and
methods including mechanical, electrolytic, electrothermal, al, lic, or sonic
devices, systems, arrangements and methods.
The medical device can be used as part of various systems, methods,
and medical kits. These systems, methods, and medical kits can be used to treat
saccular arterial sms, such as a saccular cerebral aneurysm, and to occlude a
t of an artery or vein, or other biological t, such as a ductus arteriosus,
bronchus, pancreatic duct, bile duct, , or fallopian tube. These systems, methods,
and medical kits can be used to treat a variety of medical conditions.
The Expandable Body
In various embodiments, an expandable body configured for the
occlusion of saccular cerebral aneurysms is generally referred to as a ballstent, and can
have many shapes including a spherical, spheroid, ellipsoid, or cardioid shape. In
various other ments, the expandable body may be configured as a blockstent for
the occlusion of the lumen of biological conduits, including artery and vein ts,
and can have many shapes including an oblong or generally cylindrical shape, including
a cylindrical shape with both flat and rounded ends.
2014/030869
Generally, spherical ballstents 100 and 150 are shown in FIGS. 1A-D,
and 2A-4B. In particular, a spherical ballstent 100 is shown in an expanded state, in
FIGS. 1A-4A. The ballstent 100 and 150 has a proximal neck 116, protruding away
from the ballstent, that defines an opening 112 for the e of fluids, s, gases,
gels, or solids into or though the void of the ballstent. In the ballstent 100 shown in
FIGS. 18, the neck 116 protrudes into the void to define the opening 112 for the
passage of fluids, liquids, gases, gels, or solids into the ent 100.
Another spherical ment of the ballstent 100 is shown in
in an expanded state. This embodiment includes a proximal neck 116 that defines an
opening 112 for the e of fluids, liquids, gases, gels, or solids, into or through the
ballstent. The ballstent 100 also includes a distal neck 118, protruding away from the
ballstent, that defines an opening 114 for the passage of a guide wire 302 or a coil 162,
as shown in FIGS. 2A-B and 3A-B, through the ballstent or from the interior of the
ballstent to the exterior of the ballstent, including distal to the distal neck. A similar
spherical embodiment of the ent 100 is shown in in an expanded state.
This embodiment includes the proximal neck 116 that defines the opening 112 and the
distal neck 118 that defines the opening 114, both which protrude into the interior of the
ballstent 100, for the passage offluids, liquids, gases, gels, or solids, including a guide
wire 302 or a coil 162, into or through the interior of the ent.
Ultimately, the metallic expandable bodies disclosed herein may have
a variety of configurations and any of the configurations may be employed for a variety
of uses including occluding aneurysms, including saccular aneurysms, and segments of
biological conduits, including arteries and veins. Generally speaking, some
configurations may lend themselves more readily or effectively to one application or
another. For example, the spherical expandable bodies 100 of FIGS. 1A-D may be
particularly advantageous when acting as a ent for the filling of the lumen (or void
or cavity) of a saccular aneurysm. Similarly, as explained further below, the spherical
expandable bodies 100 and 150 of FIGS. 1A-D and 2A-4B and the expandable bodies
140 and 170A-F of FIGS 6A-D, 8A-S, 16G, and 16K, for example, may be used with a
coil or ory coil 162 to fill at least a n of the lumen (or void or cavity) of a
saccular aneurysm and reduce or obstruct the flow of blood through opening from the
parent vessel to the lumen of the aneurysm, or reduce or obstruct the flow of blood
through the neck of a saccular sm into the body of the aneurysm lumen (or void,
or cavity). In various embodiments, the coil or accessory coil 162 comprises a self-
ing material, such as nitinol wire.
In some embodiments, as shown in FIGS. 8A-G and 8U, the
expandable bodies 170A-G can be characterized to include a proximal region 174A-G,
an intermediate region 173A-G, and a distal region 172A-G, wherein the proximal region
and distal region are generally opposite each other. For each body 170A-G, proximal
region 174A-G, the intermediate region 173A-G, and the distal region 172A-G form the
unitary construction of the expandable body. For this characterization, the al
region, the intermediate region, and the distal region together form a “main body” of the
expandable body, which excludes the necks. The expandable bodies 170A-G may
further be defined by a first axis 176 and a second axis 178 transverse to the first axis.
In one aspect, the first axis 176 s between the necks 116 and 118.
In one embodiment, the shape of the intermediate region 173A-G of
the expandable bodies 170A-G may be defined by the rotation, about the first axis 176,
of a variable radius arc formed along the first axis, where the maximum radius for the
variable arc is equal to either the maximum radius 181 of the distal region 172 or the
maximum radius 180 of the al region 174, as measured along the second axis
178. For some ments, the expanded expandable body 170A-G has a total
length 179 along the first axis 176 that is less than or equal to the m diameter
182 of the expanded expandable body along the second axis 178.
In some embodiments without an intermediate region, as shown in
FIGS. 8A-G and 8U, the expandable bodies 170A-G can be characterized to include a
proximal region 174 and a distal region 172, wherein the proximal region and distal
region are generally opposite each other. For each body , proximal region 174
and the distal region 172 form the unitary construction of the expandable body. For this
characterization, the proximal region and the distal region together form a “main body”
of the expandable body, which es the necks. The expandable bodies 170A-G
may also be further be defined by a first axis 176 and a second axis 178 transverse to
the first axis. In one aspect, the first axis 176 extends between the necks 116 and 118.
For some embodiments, the expanded expandable body 170A-G has a total length 179
along the first axis 176 that is greater than or equal to the maximum diameter 182 of the
ed expandable body along the second axis 178.
In various other embodiments, the expandable bodies may be d
and described by the proximal region 174 and the distal region 172, where each region
is generally a hemispheroid. The hemispheroid formed by each region 172 and 174 is
further defined by a semi-major axis and semi-minor axis that may be parallel with the
first axis 176 or the second axis 178, depending upon the lengths of each axis. In
various embodiments, the hemispheroid of the proximal region 174 has a semi-major
axis and semi-minor axis different from that of the distal region 172. In other
embodiments, the hemispheroid of the proximal region 174 has a semi-major axis and
semi-minor axis the same as that in the distal region 176. Similarly, for each of the
distal and al regions 172 and 174, respectively, the semi-major and semi-minor
axis may differ from one another or be identical so that the corresponding region may
have a lly shape of an oblate hemispheroid, a prolate hemispheroid, or a
hemisphere. As shown, the expandable bodies 170A-G may also be fabricated in a
variety of other configurations that have generally spheroid or ellipsoid . The
expandable bodies 170A-G may also include a proximal neck 116 and a distal neck
118.
In some embodiments, the expanded expandable bodies 170A-G have
a length 179 from the proximal neck 116 to the distal neck 118 of approximately 4 mm
to approximately 16 mm or larger and a m diameter 182 of approximately 4 mm
to approximately 16 mm or larger. As shown in FIGS. 8A-F and 8U, the maximum
radius length for the proximal regions 174A-G and distal regions 172A-G are equal,
such that the expandable bodies 170A-G have a generally circular cross-section when
viewed in cross-section along the first axis 176. As shown in FIGS. 8A-E and 8U, the
radius length at any equivalent location for the al regions 174A-G and distal
regions 172A-G may not be equal, such that the expandable bodies 170A-G may not
have a generally circular cross-section when viewed in cross-section along the second
axis 176. In other embodiments, as shown in , the radius length at any
equivalent location for the proximal regions 174A-G and distal regions 172A-G may be
equal, such that the expandable bodies 170A-G may have a generally circular cross-
section when viewed in cross-section along the second axis 176.
In one aspect, the different configurations of the expandable bodies
170A-G may be obtained by varying the maximum length (“height”) along the first axis
176 for the proximal region 174A-G and the distal region 172A-G, independently. For
example as shown in FIGS. 8A, C, and E, the height 183 for the proximal region 174A
may be smaller than the height 184 for the distal region 172A. In other examples as
shown in FIGS. 8B, D, and F, the height 183 for the proximal region 174A may be equal
to the height 184 for the distal region 172A. In other examples, the height 183 for the
proximal region 174A may be larger than the height 184 for the distal region 172A.
While both expandable bodies 170A and 170B have the same m er, the
difference in the heights for the proximal and distal regions of each expandable body
s in different overall shapes for the expandable body. As shown, the expandable
body 170A is lly heart-shaped, while the expandable body 170B has a id
shape.
In other examples shown in FIGS. 8A-F and 8U, the s 183 and
184 of the proximal portion 174A-F and distal portion 173A-F, respectively, may be
varied independently to produce a wide variety of configurations of the expandable
bodies 170A-G. The height 183 for the proximal region 1740 may be imately 2
mm, while the height for the distal region 1720 is approximately 4 mm. Similarly, the
height 183 for the proximal region 174D may be approximately 3 mm, while the height
for the distal region 172D is also approximately 3 mm. For the expandable body 170E,
the height 183 for the proximal region 174E may be approximately 2 mm, while the
height 184 for the distal region 172E is imately 3.5 mm, while for the expandable
body 170F, the height 183 for the proximal region 174F may be approximately 3 mm,
while the height 184 for the distal region 172F is approximately 4 mm. As shown, the
able bodies 170A-G may have a number of urations that may be generally
spheroid, generally spherical, or generally heart-shaped.
The metallic expandable body, such as the ed spherical
ballstents 100 and 150 of FIGS. 1A-D and 2A-4B and the ed able bodies
140 and 170A-G of FIGS. 8A-U, 16G, and 16K, may have a wall 102 composed of a
single continuous layer 122, as shown in A. The wall 102 includes a al,
preferably a metal that is biocompatible and ductile, that can be formed into a thin wall,
and can assume a variety of shapes after expansion. By way of example and not
limitation, the metal can be selected from the group consisting of gold, platinum, silver,
nickel, titanium, vanadium, aluminum, tantalum, zirconium, chromium, silver,
magnesium, niobium, scandium, , ium, manganese, molybdenum, alloys
thereof, and combinations thereof. Preferred metals include gold, platinum, and silver,
alloys thereof, and combinations thereof. Expandable bodies can also be made from
alternative materials that can be formed into thin-walled ures that are sufficiently
rigid or igid to tolerate compression and expansion, and can maintain an
expanded state in vivo. Alternative materials include rs or plastics that are
reinforced with metal coils or braids, and other materials with similar properties. The
materials forming the wall 102 and the thickness of the wall are selected such that the
expandable body 100, 140, 150, or 170A-G has sufficient rigidity to remain in an
expanded state in vivo under typical physiologic conditions after expansion and
separation from the delivery catheter, both when the pressure inside and outside the
central void or space 108 is the same or similar and when the pressure outside is
greater than the pressure inside.
r, it is desirable that the materials used to form and t the
expandable body 100, 140, 150, or 170A-G have sufficiently mechanical properties of
ductility, malleability, and plasticity to be ssed or folded without tearing and later
expanded without rupturing. In general, ductility is a measure of a material’s ability to
be deformed without breaking, while the malleability of the material determines the ease
of deforming without breaking when the metal is subjected to pressure or forces. The
ductility and malleability of a material factor into the plasticity of the material, which
generally refers to a ty of the material that permits it to undergo a permanent
change in shape without rupture or breakage. As such, the expandable bodies may be
composed of any patible materials having sufficient ductility, malleability, and
plasticity to undergo one or more compressions, folding processes, and expansions.
The central layer 122 of the wall 102 has an interior surface 106 and
exterior surface 124 that define a wall thickness 120. In particular, for FIGS. 16A and
168, the ce between the interior surface 106 and the exterior surface 124 is the
overall wall thickness 120 of the wall 102. Preferably, the central layer 122 of the wall
102 has a thickness 120 from about 3 pm to about 50 um and is preferably,
approximately 10 pm thick. The wall thickness 120 can be uniform. For example, the
wall 102 may have a m thickness of3 pm, 5 pm, 10 um, 15 um, 20 um, 30 um, 40
pm, or 50 pm. For example, the thickness 120 of the wall 102 may be selected such
that the expandable body is strong enough to resist compression from blood pulsation
but weak enough to yield and se during healing and involution of a treated
saccular aneurysm or an occluded segment of artery or vein, or other form of biological
conduit.
Alternatively, the thickness of the wall 102 at different locations may
vary in thickness. Alternatively, the expandable body 100, 140, 150, or 170A-G may be
composed of a single porous layer or wall 122, as shown in 8, with pores or
microperforations 1300 wherein at least some or all of the microperforations extend all
the way from the internal surface 106 to the external e 124. For this ment,
the wall 102 may be of a uniform thickness or a varied thickness. During expansion of
the ballstent 100 of this embodiment, the fluid medium may travel under pressure from
the void or space 108, through the wall 102 and leave the ballstent at the exterior
surface 124. For this embodiment, the microperforations 1300 may range from 1 — 500
pm in diameter. Another e range of microperforation diameters is 0.01 to 50 pm.
The expandable body 100, 140, 150, or 170A-G includes a central wall
or layer 122, optionally with an exterior wall or layer 104, and ally with an interior
wall or layer 214, as shown in D. As mentioned, the uct of the central
layer or wall 122 and the layers 104 and 214 can be uniform, porous, or combinations
thereof. In one embodiment of the ent 100 used to treat a saccular aneurysm, the
wall 102 includes a plurality of microperforations 1300 that extend completely through
the thickness 120 of the wall 102.
In one construction, the central layer or wall 122 is continuous and
formed of gold. Optionally, to this red uction, an exterior layer 104 formed
of porous gold can be added. Optionally, an interior layer 214 formed of Parylene may
be present. Optionally, an exterior layer 104 formed of Parylene may be present. In
certain embodiments where electrolysis is used to te the expanded expandable
body 100, 140, 150, or 170A-G from the delivery catheter, certain portions of the
ent or the expanded expandable body (such as the neck or body) are coated with
an insulator or polymer, such as ne. In n embodiments where electrolysis is
used to separate the expanded expandable body 100, 140, 150, or 170A-G from the
delivery catheter, n portions of the ballstent or the expanded expandable body
(such as the neck or body) are coated with a metal that is relatively resistant to
electrolysis, such as gold or platinum. These portions include the external surface, the
internal surface, or both the internal and al surfaces, while a portion of the neck or
body remains uncoated or non-insulated. In this instance, the uncoated or non-
insulated portion of the wall is electrolytically dissolved (i.e. corroded) by the passage of
an electrical current from the exposed metal of the wall into the surrounding electrolyte
(i.e. blood or serum). In certain embodiments, the uncoated or non-insulated portions of
the wall are d by masking during the coating process. In other embodiments, the
coating or insulation is removed from the uncoated or non-insulated ns of the wall
or neck, as through etching or ablation, such as with laser etching or laser ablation.
One embodiment of a generally spherical ballstent 150 is shown in
FIGS. 1A-4B. The generally spherical ballstent 100 or 150 includes the wall 102 that
forms a spherical body when expanded. In one aspect, a distal region 152 of the wall
102 includes one or more annular portions 154A-B. The annular portions 154A-B have
a radius of curvature greater than the remainder of the wall 102 such that the distal
region presents a flatter e than the remainder of the wall. The generally spherical
ballstent 150 also includes a proximal neck 116 and a distal neck 118 protruding away
from the distal region 152. In another embodiment, a distal neck can protrude into the
interior void of the expanded expandable body.
In various embodiments, as shown in FIGS. 2B-C and 2E, a bridging
catheter 160 extends through the proximal neck 116, through interior void of the
expanded expandable body and into the distal neck 118. In one aspect, the bridging
catheter 160 is an elongated tubular member component of the ry catheter that
provides structural t to the ballstent 150. In one embodiment, the bridging
catheter 160 has an outer al er in a range between approximately 0.5 and
2.0 mm and an inner diameter in a range between approximately 0.4 and 1.9 mm. In
some embodiments, the bridging catheter is a component of the delivery catheter, or is
operatively d to the delivery catheter.
In another aspect, the bridging catheter 160 provides a y to
deliver a solid material, such as a guide wire 302 or a coil 162, as shown in FIGS. 2B-C,
2E, 2G, 2N-P, 8H, 8J-O, and 8R-S, through the interior space 108 to the exterior of the
ballstent via the distal neck 118. The bridging catheter 160 may also e one or
more gs 164 for the passage of fluids, liquids, gases, gels, or even solids into the
interior 108 of the ballstent 150. Thus, as explained more fully below, the bridging
catheter 160 may be used to inflate or expand the expandable body while also
permitting a guide wire 302 or a coil 162 to pass into or through the interior 108 of the
ballstent 150 and to the exterior of the distal region 152.
In s embodiments, the openings 164 within the bridging catheter
160 may have a diameter in a range between approximately 200 um and 1 mm. As
shown in FIGS. 3A-3B, the bridging catheter 160 may be ioned such that it can
receive a coil or accessory coil 162. The coil or accessory coil 162 may be fed directly
through the lumen of the bridging catheter 160 or may be fed through a second catheter
352B (a “coil delivery catheter”) that is passed through the bridging catheter 160, as
shown in and in this way comprises a dual catheter delivery system.
The bridging catheter 160 may also permit the passage of a catheter
such as the catheter, or coil delivery catheter, 352B to pass through the interior of the
expandable body 100, 140, 150, or 170A-G, to deliver the coil or ory coil 162 to
the lumen, cavity, or void ofa saccular aneurysm. As shown, in FIGS. 2L-Q, the
catheter 3528 may be fed through the expandable body and the accessory coil 162 may
be simultaneously or subsequently fed through the catheter 3528.
The Expandable Body Exterior
As discussed, the expandable body 100, 140, 150, or 170A-G may
have one or more additional coating or layer(s) 104 on the or surface 124 of the
central layer 122, as shown in C-D. The wall 102 and any additional exterior
layers define an exterior surface 110 that, when expanded, contacts the internal wall of
the aneurysm or blood vessel. The exterior layer 104 can be of a uniform or varied
thickness, preferably between about 1 pm and about 59 pm. In one ment, the
exterior layer 124 has a thickness between 0.1 and 10 pm. In a specific embodiment,
the exterior layer 124 has a ess of about 1 pm.
The exterior layer 124 can be formed of polymers, latex, elastomers, or
metals. The exterior layer 124 may be an electrical insulator, and in a preferred
embodiment, the exterior layer 124 is formed of a ne coating. The exterior layer
124 may be a metallic or non-metallic material that is less susceptible to electrolysis or
galvanic corrosion, such as noble metals, and in red embodiments gold or
platinum. The exterior coating or layer 104 of the able body 100, 140, 150, or
170A-G may be porous and contain a plurality of pores 200, as shown in FIGS. 16C and
16D. Alternatively, the exterior layer 104 can be smooth, with d porosity or
sions. For e, the exterior layer 104 may be a polished metal surface. In
one embodiment, portions of the exterior layer 104 can be smooth, while other portions
can be porous or contain protrusions. In one embodiment, the surface variations can
include a pattern. E depicts structures of the exterior surface 110 after
electroforming and Parylene coating. As shown, the or surface 110 of the wall 102
may have rounded, pebbled, or granular ures. In various embodiments, the
rounded, pebbled, or granular surface structures have a height of approximately 0.1 pm
to approximately 10 um.
WO 46001
When configured as a porous or spongy layer, the exterior layer 104
can contain (or be configured to contain) solutions that include pharmaceutical drugs,
pharmacologically active molecules, or pharmaceutical compositions within the pores
200. As such, solutions such as pharmaceutical drugs, pharmacologically active
molecules, or pharmaceutical compositions can be delivered to the treatment site.
Drugs, cologically active molecules, or pharmaceutical compositions that
promote thrombosis, stimulate cell eration or extracellular matrix production, or
tissue growth are examples of agents that can be placed in the pores 200 of the exterior
layer 104. The pharmaceutical drugs, pharmacologically active molecules, or
ceutical compositions are incorporated into the pores 200 of the wall or the
exterior layer 104 prior to positioning the expandable body 100, 140, 150, or 170A-G at
the desired location. The drug compositions may be delivered into the pores 200 via
capillary or wicking action. The pores 200 range from about 0.01 pm to about 500 pm
in diameter. Pore diameters for each expandable body may vary according to the
ic drugs, pharmacologically active molecules, or pharmaceutical itions to
be incorporated and the desired rate of release in vivo. By way of example and not
limitation, the expandable body 100, 140, 150, or 170A-G may have a porous or
layer 104 where the pore diameter averages from about 0.01 pm to about 0.05 pm,
about 0.05 pm to about 0.5 pm, 0.5 pm to about 5 pm, about 5 pm to about 25 um,
about 25 pm to about 500 um, about 0.05 pm to about 500 pm, or about 0.01 pm to
about 500 pm.
The pharmaceutical drugs, pharmacologically active les, or
pharmaceutical compositions may include thrombin, platelet-derived growth factor,
ol®, Sotradecol®, or combinations thereof. Other pharmaceutical compounds
and compositions that promote thrombosis, stimulate cell proliferation, stimulate the
synthesis of extracellular matrix, or the growth of tissue into the porous external wall of
the expandable body 100, 140, 150, or 170A-G may also be used. Such drugs or
pharmaceutical compositions may include molecules to promote cell proliferation,
extracellular matrix production, or tissue growth, such that the ed expandable
body 100, 140, 150, or 170A-G will become more firmly attached to the tissue at the
ent location. The dosages and manner in which the pharmaceutical drugs,
pharmacologically active molecules, or pharmaceutical compositions are incorporated
into the wall 102 or exterior layer 104 are a matter of choice depending upon the
treatment performed. Other compounds may be used to promote blood clotting or
thrombosis around the expandable body. In various aspects, the pores 200 may be
filled with a biodegradable or bioerodible material, such that the volume of material in
the pores decreases over time and the pores are opened in vivo at a point in time
subsequent to placement of the expandable body. For embodiments of the expandable
body 100, 140, 150, or 170A-G with a porous layer 104, over time, the ballstent,
tent, or the expandable body remains expanded with the expanded body
eventually becoming affixed to the nding tissue.
As can be understood from FIGS. 18G-H, the exterior surface 110 of
the expandable body 100, 140, 150, or 170A-G may also include one or more
sions or projections 1800 (which may be generally tubular or have other
configurations) that can increase the strength of the attachment of the expanded body
to the adjacent tissue, and thereby reduce the risk of nt or ion. The
protrusions may have a length that ranges between about 0.01 pm to about 167 pm.
Some protrusions can have a branched construction, while others may be joined on
both ends to the exterior surface 110 to form loops. In some embodiments, the
sions are rigid, or semi-rigid. In other embodiments, the protrusions are flexible
and ike, and may further comprise globular ends, similar to the protrusions on the
surface of the footpad of the gecko. The protrusions may be attached to the
expandable body 100, 140, 150, or 170A-G after formation. Alternatively or additionally,
the protrusions may be incorporated into the expandable body during electroforming.
In another embodiment, the ballstent 100 may comprise a porous
external layer or wall 104 or a wall with external protrusions 1800 to promote thrombus
ion on the external surface 110 or in the pores 200 and e cell proliferation,
extracellular matrix production, or tissue growth into or around the wall 102 of the
ballstent 100 such that the ballstent 100 will, over time, become more ly attached
to the tissue in the adjacent aneurysm wall.
As shown in FIGS. 18A-D, the central layer 122 and the porous
exterior layer 104 of the ballstent 100 placed into the aneurysm 700 may be configured
to promote thrombus 1206 formation on the exterior layer. The thrombus may be
comprised of red blood cells 1208, platelets 1210, and fibrin 1212. Over time, the
us 1206 may be partially absorbed into the exterior layer 104, as new endothelial
cells 1214 are formed over the thrombus. The new endothelial cells may form a seal of
connective tissue 1216 across the opening of aneurysm 700. In addition to sealing the
g of the aneurysm 700, tive tissue 1216 from the wall 704 of the
aneurysm may grow into the porous exterior layer 104 of the ballstent 100 to adhere the
ballstent to the wall of the aneurysm, as shown in E.
In other embodiments, the projections or protrusions 1800 may be
lly tubular, straight, curved, hook-shaped, or configured as pigtail hooks as
shown in FIGS. 18G-H. In a macroscopic form, the projections may be composed of
nitinol or any other suitable biocompatible material.
H depicts an expanded ballstent 100 that is anchored to the
wall 704 of an aneurysm 700. The size and shape of the protrusions may be selected
based upon the ion being treated, and may be designed and dimensioned to
provide sufficient anchoring t without g excessive damage to the wall of
the aneurysm or the surrounding tissue. Alternatively, microscopic protrusions or
filaments may be used to anchor the ent. For some embodiments, these
microscopic protrusions range in length from 0.01 pm to about 57 um, and can be
straight or branching. In s embodiments, both ends of one or more of the
protrusions may be joined to the exterior surface 110 of the ballstent 100 and/ or the
exterior surface 216 of the wall 102 to form a loop.
The ballstent or expandable body 100, 140, 150, or 170A-G may also
be used to contain or trap a thrombus, such as a mural thrombus, that has formed
within an aneurysm or other biological space. As shown in F, an expandable
body 170G may be placed within an aneurysm 700 having one or more thrombi,
including a mural us 707, within the cavity 701 or dome of the aneurysm. In one
aspect, an expandable body 170G having an expanded volume smaller than the volume
of the aneurysm cavity 701 is selected. The expandable body is delivered to the
aneurysm, inflated or expanded, and contacted by an inserted accessory coil 162, as
previously described. In this aspect, the accessory coil 162 aneously contacts the
expandable body 170G, the thrombus 707, and the wall of the aneurysm. The
expandable body 170G in conjunction with the accessory coil 162 acts to trap the
thrombus 707 within the aneurysm holding it in places until absorption by the patient.
In various embodiments, an expandable body that does not
completely fill the cavity 701 of an aneurysm 700 that may ially contain a blood
clot is preferred. As such, a larger expandable body that more fully fills the cavity 701,
is less desirable as it may force thrombus within the sm 700 out into the parent
blood vessel 1202 or 1203, where the thrombus may ze, travel through the
vascular system, and cause a stroke.
In s embodiments, the expandable body 100 may include a thin
polymer sheath that is wrapped around the entire body of the expandable body when in
the delivery or deliverable configuration. The sheath may be added to the exterior of
the expandable body 100 during fabrication of the expandable body. The sheath may
be affixed to a proximal nose cone 3628, a distal nose cone 360 or 362A, or both, such
as those shown in FIGS. 2A-Q. The polymer sheath increases trackability of the
able body 100 and s on with the lining of blood vessels as the
expandable body is delivered through the vascular system. During ion or
expansion of the expandable body 100, the polymer sheath opens while remaining
affixed to the expandable body, the delivery catheter, the proximal nose cone 3628, or
the distal nose cone 360 or 362A. In one embodiment, the sheath may be perforated or
partially scored before deployment to allow for easier expansion of the expandable body
100.
The Expandable Body Interior
In some ments, the expandable body 100, 140, 150, or 170A-G
may include an additional layer or liner 214 on the interior surface 106 of the central
layer 122, as shown in FIGS. 16D, 16F, 16H, 16J, and 16L. The interior layer may be
made from the same materials as the central layer, or can be made of different
materials. The interior layer may be formed of gold, platinum, silver, alloys thereof, or
combinations thereof. The additional layer 214 on the interior surface 106 of the central
layer 122 of the expandable body 100, 140, 150, or 170A-G may also be formed of a
polymer, plastic, latex, rubber, woven or knitted fiber material, metal, or another
material, or combinations thereof. Preferably, the interior layer 214 is an elastomeric
coating that is bonded to the interior surface 106 of the central layer 122. The interior
layer 214 can be a variety of thicknesses, preferably ranging between about 0.1 pm and
about 59 pm. In one embodiment, the interior layer 214 has a ess between about
0.1 pm and about 10 pm. The total thickness of the wall 102, including the central layer
122, the exterior layer 104, and the interior layer 214 is preferably between about 2 pm
and about 50 um, regardless if the wall contains one, two, three, or more layers. The
interior layer 214 can se polymers, latex, or elastomers. In a preferred
ment, the interior layer 214 comprises Parylene. The or layer 214 also
adds mechanical properties (such as strength) to the wall 102. Further, the interior
layer 214, optionally, can form a seal that prevents the escape of a fluid medium from
the able body 100, 140, 150, or , should the central layer 122 contain a
defect or hole. The central layer 122 and any additional layers define an interior surface
106 or 218, respectively, such that when the ballstent or the expandable body is
expanded, with a fluid, liquid, gas, or solid, a l void or space 108 is defined. As
shown in D, the distance between the interior surface 218 and the exterior
surface 110 is the overall wall thickness 120 of the wall 102.
The Expandable Body Neck(s) and g(s)
As illustrated in FIGS. 1A-D, 2A-4B, 8A-S, 8U, 16A-D, 16G, and 16K,
the expandable bodies 140, 150, or 170A-G have one or more openings 112 and 114
defined by the wall 102 or by the proximal neck 116 or the distal neck 118. In various
embodiments, the ent, blockstent or expandable body has one or more openings
112 and 114 defined by necks 116 or 118, respectively. In all embodiments, a fluid
medium can enter the opening 112 and move into the central void or space 108 d
by the interior e 106 or 218, thereby inflating or expanding the expandable body.
In various embodiments, one or both of the necks 116 and 118 may extend outwardly
from its respective end region (proximal region or distal region) of the expandable
bodies 100, 140, 150, or 170 A-G as shown in FIGS. 1A, 10, 2A-4B, 8A-S, 8U, 16G and
16K. ately, one or both of the necks 116 and 118 may extend inwardly from its
respective end region and into the interior void 108, as rated in FIGS. 1B and 1D.
The proximal necks 116 can be used for attaching the expandable body 100, 140, 150,
or 170A-G to the delivery catheter and may function in separating the ballstent or the
expandable body from the delivery catheter. In various embodiments, the necks 116
and 118 and the wall 102 or main body may be formed from different metals. For
example, in one embodiment, the neck(s) 116 and 118 and the wall 102 or main body
may be formed by gold. In other embodiments, the neck 116 and 118 may comprise
stainless steel, ing but not limited to 304 series or 316L series stainless steel and
the wall 102 or main body may be formed by gold, platinum, or another malleable metal.
The neck 116 and 118 may comprise multiple metals, such as stainless steel and
another metal such as gold or platinum, including embodiments wherein the various
regions of the expandable bodies 100, 140, 150, or 170A-G are ct in their metal
content and embodiments wherein the different metals are formed in layers in the
various regions, ing an embodiment wherein a neck comprises an or layer of
stainless steel with an exterior layer of gold and an embodiment wherein a neck
comprises an central layer of ess steel with interior and or layers of gold,
including embodiments wherein at least a portion of the e of the exterior layer is
stainless steel, including embodiments n a portion of the gold exterior layer is
absent through masking or through etching, including laser etching.
Additionally, the necks 116 and 118 can be designed and
dimensioned such that the opening 112 or 114, preferably the proximal opening 112,
can be closed or partially closed before, during, or after separation of the expanded
body from the delivery catheter. One or more openings 112 or 114 may remain open.
Optionally, before, during, or after tion, the necks 116 and 118 may be folded,
pinched, or closed to form a seal. The necks 116 and 118, or alternatively the stainless
steel ring 250, may have a length N1, as shown in FIGS. 24A and 300, ranging
WO 46001
between about 0.5 mm and about 20 mm, preferably a length between about 0.5 mm
and about 5 mm. In one embodiment, the neck length N1 is imately 1.27 mm 1r
0.08 mm.
In various embodiments, at least one of the necks 116 and 118 and the
stainless steel ring 250, as shown in FIGS. 2A-E, 24A, and 30D, have an outer diameter
N2 and an inner diameter N3 that defines the openings 112 and 114, respectively. The
outer er N2 is in a range between about 0.25 mm and about 2 mm and the inner
diameter N3 is in a range between about 0.24 mm and about 1.95 mm. In one
embodiment, the neck outer diameter N2 is approximately 0.99 1r 0.01 mm and the neck
inner diameter N3 is imately 0.89 1r 0.01 mm.
The thickness of the walls of either or both of the necks 116 and 118
may be the same as the main body of the ballstent, blockstent, or the expandable body
or may be thinner or thicker than the wall of main body. Preferably, either or both of the
necks 116 and 118 have a wall thickness N4 between about 3 pm and about 60 pm, as
shown in FIGS. 24B-C, 30D, and 30F. In one particular embodiment, the neck has a
thickness of approximately 50 pm. In one embodiment of the ballstent 100 where the
neck(s) 116 and 118 extend into the central void space 108 as indicated in FIGS. 1B
and 1D, the al surface 110 of the expanded ballstent s a more rounded
surface r, increasing the strength of the expanded ballstent and reducing the risk
of damage to the aneurysm wall or the adjacent tissue during placement.
One or both of the necks 116 or 118 can be coated or insulated on the
inner wall, outer wall, or both. This coating can include metals such as gold or platinum
and polymers such as Parylene. In addition, the necks 116 and 118 may include one or
more caps or nose cones 360, as shown in FIGS. 2A-C and 4A-B or nose cones 362A-
B as shown in FIGS. 2D-Q, to improve trackability of the expandable body 100 during
delivery and placement. In addition to improving the trackability of the able body
100 during placement, the nose cones 360 or 362A-B also serve to protect the necks
116 and 118 during positioning, as well as reducing the risk of damage to the walls or
lining of any blood vessels or conduits traversed by the expandable body 100 during
placement. In some embodiments, a nose cone affixed to the distal portion of the
delivery catheter can serve the same e.
As shown in FIGS. 20 and 4B, the nose cones 360 or 362A-B include
a central channel 364 that encircles and engages the necks 116 and 118. In one
embodiment, the nose cone 360 is generally cylindrical as shown in FIGS. 2A-C and
4A-B, while in other embodiments, the nose cones 362A-B may have a conical or
“bullet-shaped” configuration, as shown in FIGS. 2D-Q. The nose cones 360 or 362A-B
may be composed of any biocompatible material, including polymers and metals. In
one embodiment, the nose cones 360 or 362A-B are composed of PTFE. In various
embodiments, the nose cones 360 or 362A-B hay have an outer diameter in a range
between approximately 0.75 and 2.5 mm, an inner diameter in a range n
approximately 0.25 and 2 mm, with a length in a range between approximately 1 and 4
In various embodiments, the necks 116 and 118 are r modified to
provide a detachment point for ing the expandable body 100, 140, 150, or 170 A-
G from a delivery catheter. For example, a strip of electrically conductive material,
including an uncoated or non-insulated section of a neck, weld, solder, or other fixation
point, or a portion of the ballstent, blockstent or the expandable body itself, is left
exposed, uncoated, or non-insulated or later exposed after coating, including an
exposed, uncoated, or non-insulated region that in the shape of a circumferential or
ring-shaped d surface of metal or conductive materials that can be subjected to
electrolysis to e separation between the expanded expandable body and the
distal end of the delivery device. Preferably, a stainless steel ring is affixed to the wall
102 or the main body of the able body, as stainless steel is highly sensitive to
galvanic corrosion and electrolysis. For e, as can be understood from FIGS.
16E, 16G, 16l, 16K, 28, and 30A-B, in one embodiment, at least a portion of an inner
surface of the metal layer of the neck of the metallic expandable body is electrically
insulated by having an outer surface of a distal portion of the delivery device extending
along the inner surface of the metal layer of the neck of the metallic able body.
In some ments, on the inner surface of the proximal neck 116, a proximal
boundary of the ring-shaped exposed metal surface may be defined by a distal
boundary of the delivery device in the neck region and a distal boundary of the ring-
shaped exposed metal surface may be defined by a ry of the inner insulation
layer in the neck region. For the outer surface of the proximal neck 116, both the
proximal and distal boundary of the haped exposed metal surface may be defined
by a boundary of the outer insulation layer in the neck region. In such an embodiment,
the distal end of the delivery catheter 300 or 400 may distally terminate near a proximal
edge of the ring-shaped exposed metal surface of the neck. As indicated in A, a
conductive wire can be engaged in electrical contact with the uncoated or non-insulated
portion of the neck or a weld or solder between a neck and the ry catheter, or on
the expandable body itself 100, 140, 150, or 170A-G to allow the uncoated or non-
insulated portion to be dissolved (corroded) or removed via electrolysis.
In other embodiments, one or both necks 116 and 118 may be affixed
with a metallic ring 250, as shown in FIGS. 2A, 28, 5A, and 5B, which may be
uently d using electrolysis. The metallic ring 250 may be composed of
stainless steel and, as explained below, may be subjected to one or more heating
procedures to sensitize the steel to ic corrosion, thereby allowing for faster
separation or severing via electrolysis.
Expandable Body Shapes and ions
FIGS. 16E-F and 16I-J illustrate a ballstent 100 and a delivery catheter
220 that may be used to deliver the ent. In one characterization, the ballstent 100
includes a distal region 202 that includes the distal end 204 of the ballstent. nt to
the distal region 202 is an ediate region 206 where the ballstent transitions from
the distal region 202 to a proximal region 208 that includes a al end 210 of the
ballstent. The proximal region 208 is generally opposite the distal region 202. A center
axis 212 extends proximal-distal between the proximal region 208 and the distal region
202. The ballstent wall 102 extends lly continuously through the intermediate
region 206 from the proximal region 208 to the distal region 202, and the ballstent 100 is
in the form of a single-lobed metallic expandable body. In another characterization, the
ballstent 100 includes a distal region 222 that is joined directly to a proximal region 228
that is generally opposite the distal region 222. A center axis 212 extends proximal-
distal between the proximal region 208 and the distal region 202. The ballstent wall 102
extends generally continuously from proximal region 208 to the distal region 202 and
the ent 100 is in the form of a -lobed metallic expandable body.
In one embodiment, when the ballstent 100 is ed, the
intermediate region 206, the proximal region 208, and the distal region 202 combine to
form a generally spherical shape. In various embodiments, the dimensions of the
ballstents 100 are ed based upon the size and shape of the saccular aneurysm
being treated. Preferred shapes of the ballstent 100 include round, oblong, and
irregular. The diameter of the round expanded ent 100 ranges from about 2 mm to
about 30 mm, and preferably has an expanded diameter ranging from about 2 mm to
about 20 mm. The expanded length of oblong ballstent or blockstent preferably ranges
between about 2 mm to about 30 mm. The ballstent 100 may have an expanded
volume that ranges between about 0.001 mL to about 65 mL. In preferred
embodiments, the expanded diameter of the spherical ent 100 ranges from about
2 mm to about 10 mm, while the preferred expanded volume ranges from about 0.004
mL to about 40 mL. In preferred embodiments, the expanded length of the oblong
ballstent or blockstent 100 ranges between about 2 mm to about 30 mm.
FIGS. 16G-H and 16K-L illustrate an expandable body 140 and a
catheter 220 that may be used to deliver the expandable body. In some embodiments,
the expandable body 140 can include a generally cylindrical intermediate region 206
(where the longitudinal axis of the cylindrical portion is perpendicular to the central axis
212), a generally hemispherical al region 208 and, a generally hemispherical
distal region 208, as shown in G. In other embodiments, the expandable body
140 can include a generally rical ediate region 206 (where the longitudinal
axis of the cylindrical n is aligned along a longitudinal axis of the neck 116), a
generally hemispherical proximal region 208 and, a generally hemispherical distal
region 208, as shown in A. The intermediate region 206 may have a radius R1
that is equal to the radius R2 of both the proximal region 208 and the distal region 208,
as shown in A. In various embodiments, the delivery catheter 220 is typically
engaged to the proximal neck 116 or proximal region 208 of the expandable body.
In other embodiments, one or more ns of the able body
wall 102 may be thicker than the ing portions of the wall. By way of example and
not limitation, the wall in the middle of the main body or the intermediate region of the
expandable body may be thicker or thinner than the wall in the proximal and distal
regions or portions of the expandable body, or the wall of a neck may be thicker or
thinner than the main body of the expandable body. In various embodiments, the wall
thickness 120, as shown in FIGS. 16A-D, may be scaled relative to the l diameter
of the expandable body to avoid undesired increases in wall stress with increases in
diameter. In various embodiments of the expandable body 100, 140, 150, or 170A-G, a
balance can be made between a wall thickness 120 that is thin enough to enable the
various small compressed forms of the ry configuration and to permit expansion of
the expandable body at lower pressures, and a wall thickness that is thick enough to
maintain structure integrity and resist compression after delivery and detachment.
Therefore, the average wall thickness 120 is preferably in a range between about 10 um
and about 50pm. By way of example and not limitation, the wall thickness 120 for an
expandable body 100, 140, 150, or 170A-G having an expanded diameter of about 4
mm may be about 10 um, while the wall thickness for an expandable body having an
expanded diameter of about 10 mm may be about 25 pm.
As shown in A, the expandable body 140 may have a generally
cylindrical shape with d or hemispherical ends (where the longitudinal axis of the
cylindrical shape is aligned with a longitudinal axis of the neck 116), such that the total
length L1 of the main body of the expandable body parallel to the first axis is r
than the total width of the expandable body parallel to the second axis (i.e. twice the
radial distance R1). In other embodiments, the expandable body 140 may have a
lly cylindrical shape with flattened or flat ends as shown in FIGS. 16G and 16K,
such that the total length of the main body of the expandable body along the central axis
212 is less than the total width of the expandable body dicular to the central axis.
The expandable body 140 is in the form of a single-lobed ic expandable body.
2014/030869
In various ments, the able body 140 has an expanded
diameter (both along the center axis 212 and perpendicular to the center axis) ranging
from about 2 mm to about 30 mm. Assuming no change in wall thickness 120, the
stress in the wall of expandable body 140 will increase, as the radius R1 (see A)
of the intermediate region 206 increases. Therefore, in some embodiments, the
diameter of the expandable body 140 is limited by the ultimate e strength of the
al (e.g. gold) used to form the expandable body and by the pressure required to
expand the compressed expandable body. As can be understood from A, the
expandable body 140 may have an expanded length L1 of between about 2 mm to
about 120 mm, such length L1 comprising the proximal region, intermediate region, and
distal region. ably, the length is between about 5 mm to about 60 mm, and in a
particular embodiment the expanded length L1 is approximately 40 1r 0.03 mm and the
length L2 of the intermediate region 206 may be approximately 24 i 0.03 mm, such
length L2 comprising only the intermediate region.
The concentration of stress between the neck 116 and the proximal
region or end 208 of the expandable body 100, 140, 150, or 170A-G may be reduced or
offset by increasing the radius R4 between the neck and the al region, as shown
in FIGS. 24B-C. For example, the stress experienced by the wall 102 in 8
having a radius of R4 is greater than the stress experienced by the wall in 0
having a radius of R4’, where R4’ is r than R4. In addition, stress may be
concentrated at the point where the neck 116 transitions to the wall of the proximal
region 208 of the expandable body 100, 140, 150, or 170A-G due to a metallic ring
incorporated into the neck 116 during formation of the expandable body. This stress
concentration may be mitigated by reducing the overall wall thickness N4 of the neck
116. By way of example and not limitation, the neck 116 shown in 8 may have a
wall thickness N4 of approximately 25 um, while the neck shown in 0 may have
a wall thickness N4’ of imately 12.5 um.
Expansion of the Expandable Body
The central void or space 108 of the expandable body 100, 140, 150,
or 170A-G can be filled with fluids, gels, solids, or combinations thereof to expand or
2014/030869
inflate the expandable body 100, 140, 150, or 170A-G. The terms expand, inflate, and
forms thereof may be used interchangeable to refer to the action of changing the
expandable body from the delivery or deliverable configuration to an expanded or at
least partially expanded configuration. A fluid medium is a substance having particles
that easily move and change their relative position without a separation of the mass.
Fluid media that may be used to expand the expandable body 100, 140, 150, or 170A-G
include liquids, gases, gels, and combinations thereof. By way of example and not
tion, the fluid medium may be water, a saline solution, a radiographic contrast
solution, or a mixture thereof. In one ment, the fluid medium may further include
a solution or suspension of a drug, pharmacologically active molecules, or a
pharmaceutical preparation.
In various embodiments, the shape and construction, including multi-
layer constructions, of the expandable body 100, 140, 150, or 170A-G permits the
expandable body to remain in an inflated or expanded configuration without the use of
any support structures not derived from the patient. For example, the fluid medium
used to inflate the expandable body 100, 140, 150, or 170A-G, and optionally blood
from the patient, will fill the interior void 108 and cause the ballstent, blockstent, or the
expandable body to remain in an expanded uration. In addition, support
structures derived from the patient, including but not limited to blood clots and tissue
ths, may t and maintain the structural integrity of the expandable body
100, 140, 150, or , when expanded.
In one ment, as shown in FIGS. 17A-B, the expandable body
100, 140, 150, or 170A-G may be used to seal a ar aneurysm 700 located near
the junction of blood vessels 1202 and 1203. As shown, the expandable body 100, 140,
150, or 170A-G may be positioned and inflated by the delivery catheter 352A to seal the
opening 703 of a saccular aneurysm 700 with the aid of a coil or accessory coil 162 that
is introduced into the sm by passage through the delivery catheter 352A and
h the expanded expandable body. The coil or accessory coil 162 contacts the
wall of the aneurysm 700 (including the wall opposite the opening from the parent
vessels 1202 and 1203 to the aneurysm 703) as well as the exterior of the expandable
WO 46001
body 100, 140, 150, or 170A-G, where the coil 162 exerts a force, as indicated by 705
upon the expandable body towards the opening 703 to press the expandable body
against the opening. As a result, the expandable body 100, 140, 150, or 170A-G
ts the flow of blood, as indicated by 706, from entering the aneurysm. In one
aspect, the expandable body 100, 140, 150, or 170A-G may be fully expanded before
introducing the accessory coil 162. In another aspect, the accessory coil 162 may be
introduced, at least partially, before inflation of the expandable body 100, 140, 150, or
170A-G. In yet another aspect, the expansion of the expandable body 100, 140, 150, or
170A-G and the introduction of the accessory coil 162 may occur simultaneously or in
an alternating incremental fashion. In certain ments, after inflation or expansion
of the expandable body 100, 140, 150, or 170A-G and ion of the coil or accessory
coil 162, the expandable body 100, 140, 150, or 170A-G is detached from the delivery
catheter 352A by electrolysis that corrodes a portion of the proximal neck 250, including
a ring-shaped region of exposed stainless steel.
In one embodiment, multiple coils or accessory coil(s) 162 may be
deployed within the aneurysm 700. In one ment, as shown in 0, a
portion of one or more coil or accessory coil 162 is ed within the lumen, void, or
cavity of the aneurysm while another portion of the coil is deployed within the void of the
expandable body 100, 140, 150, or 170A-G. For example, after inflating or expanding
the expandable body, an accessory coil delivery catheter 3528 may be fully inserted
through delivery catheter 352A, through the expandable body 100, 140, 150, or 170A-G,
and into the lumen of the sm 700 and the accessory coil 162 may be inserted
into the unfilled n of the aneurysm 700. The coil delivery er 3528 is then
retracted so that its distal end is located within the expandable body 100, 140, 150, or
170A-G and the der of the ory coil 162 or another ory coil is
deployed with the expandable body. The deployment of the accessory coil 162 both
within and external to the expandable body 100, 140, 150, or 170A-G may serve to
stabilize and maintain the position of the expandable body within the aneurysm 700.
In another embodiment, the accessory coil 162 may be magnetic,
such that multiple accessory coils may be deployed to stabilize the expandable body
100, 140, 150, or 170A-G within an aneurysm through the magnetic attraction of the
coils. For example, as shown in D, a first magnetic ory coil 162A may be
deployed within an inflated expandable body 100, 140, 150, , as usly
described. One or more other ic accessory coils 1628 are then deployed within
the neck or opening 703 of the aneurysm 700. The ory coil 162B fills and
occludes any residual space in the neck or opening 703 after deploying the expandable
body 100, 140, 150, or 170A-G. In one aspect, the accessory coils 162A-B are
attracted to and contact the exterior surface of the expandable body 100, 140, 150, or
170A-G. In another aspect, the accessory coils 162A-B are attracted to one another
through the wall of the expandable body 100, 140, 150, or .
In various other embodiments, the shape of an expanded expandable
body 100, 140, 150, or 170A-G is maintained by placing solid material or t
structures into the central void or space 108. Examples of this solid material include
metal or polymeric coils or wires, metal or polymeric solid support structures,
bioresorbable materials, radially expansile materials, beads, particles, granules,
spheres, microspheres, or sponges. In certain embodiments, these solid als can
also be used to help expand the expandable body 100, 140, 150, or 170A-G. In other
embodiments, these solid materials are added after expansion. In one embodiment, as
shown in E, the aneurysm 700 within the parent blood vessel 1202 is filled with a
ballstent 100 containing at least one coil or expansile wire 1204. In one aspect, the
expandable body 100, 140, 150, or 170A-G may be expanded by the coil or expansile
wire 1204 only. In other aspects, the expandable body 100, 140, 150, or 170A-G may
be expanded by a fluid medium, and the solid materials may be added later to provide
support to maintain the ed shape of the expandable body, or vice versa. Other
suitable biocompatible solid als may also be used. The solid fill members can
function as a lattice to insure the structural integrity of the expandable body 100, 140,
150, or 170A-G. For example, the coil 1204 can promote the structural integrity of the
expandable body 100, 140, 150, or 170A-G and reduce compression of the expandable
body. In one ment, solid material may be designed and manufactured to match
an expandable body 100, 140, 150, or 170A-G of a particular size or shape, and may be
packaged as part of the medical device for use with the ed expandable body.
In the event that the expandable body 100, 140, 150, or 170A-G is not
appropriately sized or positioned for the desired treatment, the expandable body may be
intentionally collapsed and recaptured. In one embodiment, where the expandable
body 100, 140, 150, or 170A-G is still attached to the delivery catheter, a negative
pressure can be generated within the ry catheter to assist in the collapse of the
expandable body. In this embodiment, the expandable body 100, 140, 150, or 170A-G
may re-collapse due to the vacuum pressure alone.
In other embodiments, additional efforts are necessary to collapse the
expandable body 100, 140, 150, or 170A-G after deployment due to the inherently
stable geometry of expandable body. onally, structural features may be
incorporated into the expandable body 100, 140, 150, or 170A-G to facilitate an
intentional collapse. For e, a series of vertical s may be created in
expandable body 100, 140, 150, or 170A-G during the electroforming s to create
geometric stress concentrations that encourage collapse under sufficient vacuum
pressure. In another embodiment, the exterior surface of the expandable body 100,
140, 150, or 170A-G is coated with a polymer (including a thick polymer) and then the
polymer coating is etched ding by laser etching) to leave a series of “ribs”,
channels or grooves along exterior surface 110 of the expandable body. The grooves
may be formed laterally or longitudinally around the expandable body 100, 140, 150, or
170A-G.
In other embodiments, one or more tools designed to collapse the
expandable body 100, 140, 150, or 170A-G may be used. In one example, an
elongated tubular collapsing tool having a number of outwardly biased or splayed
“fingers” may be used. The fingers are collapsed inward when the collapsing tool is
inserted into patient. When the sing tool is actuated, the s spring out radially
and encircle the ed expandable body 100, 140, 150, or 170A-G. The collapsing
tool is then ted such that the s engage and compress and deflate the
expanded expandable body 100, 140, 150, or 170A-G. A vacuum may also be applied
throughout the process to encourage collapse of the expandable body 100, 140, 150, or
170A-G.
The able Body in Use
Advantageously, as illustrated in F, the ballstent 100 can be
delivered into the lumen, cavity, or dome 701 of a saccular aneurysm 700, expanded,
and then separated from the ry catheter 300, such that the delivery catheter can
be removed while the ed ballstent s in place filling a portion, substantially
all, or all of the lumen of the aneurysm in an expanded state. The expanded ballstent
100 will typically conform to the shape of the saccular aneurysm cavity 701 in which it is
placed. The expanded ballstent 100 can also be shaped with external force, such as a
physical force d by the inflated balloon portion 1102 of an adjacent balloon
catheter 1100, as shown in F. With precise placement and shaping, the
ballstent 100 can be positioned such that the saccular aneurysm cavity 701 is
tely or substantially filled and sealed, and further with none of the ballstent, or a
l amount of the ballstent, extending into the lumen of the parent vessel 1202
from which the saccular aneurysm has formed.
When treating saccular aneurysms of various shapes, a host of
expanded ballstent shapes are acceptable, including circular, oblong, and lar, so
long as the shape is generally rounded and the expanded ballstent includes a single
lobe. less of the formed shape, when a ballstent is expanded in the cavity 701
of an aneurysm sac 700, in one embodiment, the ballstent is designed to conform, at
least partially, to the shape of the cavity.
In one embodiment, the expandable body may be used to treat a
bifurcation aneurysm that is located at the intersection of two or more blood vessels. As
shown in G, a bifurcation aneurysm 600 has a neck or opening 603 that forms
an approximate right angle to the blood vessels 1202 and 1203. In one aspect, the
ation aneurysm 600 may be treated by an expandable body 170G as shown in
FIGS. 8T-V, where is a view of the expandable body when the proximal region
174G is viewed along the first axis 176, as indicated by 185. The expandable body
170G includes a proximal region 174G that has generally frustoconical in configuration
and a distal region 172G that has a configuration similar to any one of the distal regions
172A-G of the able bodies 170A-G, shown in FIGS. 8A-F and 8U. The
expandable body 170G also includes proximal and distal necks 116 and 118,
respectively. As shown in G, the frustoconical configuration of the expandable
body 170G permits the expandable body to make contact and seal the perpendicular
es of the blood vessels 1202 and 1203 at the g 603 of the bifurcation
sm 600. The deployment of coils or accessory coil(s) 162 within and/or external
to the expandable body 170G may further serve to stabilize and maintain the position of
the expandable body 170G within the bifurcation aneurysm 600.
Research suggests that the presence of an intact endothelium
correlates with expansion of the lumen of blood s and aneurysms in n
clinical situations. In these settings, endothelial cells sense changes in the lumen of
blood vessels or aneurysms and stimulate biological processes that lead to an increase
in cellular and enzyme activity in the wall of blood vessel ts or aneurysms
associated with changes in the extracellular and cellular components of the wall and
expansion or enlargement of the lumen. Research has also shown that endothelial cells
require flowing blood on their luminal e to remain healthy and viable. Therefore, a
medical , , or method that could reduce or eliminate flowing blood over the
luminal surface of endothelial cells lining an sm or blood vessel segment could
thereby reduce endothelial cell viability, reduce biochemical signaling from endothelial
cells, and cellular, and reduce enzymatic activity associated with blood vessel or
aneurysm expansion or enlargement, which is an important goal in preventing or
treating aneurysms. Given this, in certain embodiments, the ballstent 100 is fully
expanded to treat a saccular aneurysm. In addition to the physical nature of the filling
and blocking effect of the expanded ballstent in the aneurysm sac, this ent also
reduces endothelial viability in the aneurysm sac. In other embodiments, the ballstent
100 need not be fully expanded to treat a saccular aneurysm, but may successfully seal
the aneurysm or reduce endothelial cell viability while partially expanded. In all
embodiments, the ballstent remains in an expanded state ally or completely) after
detachment from the delivery catheter. An expanded state refers to the at least partial
tion of the ballstent 100, such as at least 20%, 50%, 75%, or 90% and up to 100%
of the maximum ballstent volume. In various aspects, the size of the biological space
may be determined by any suitable method. The size and configuration of the
expandable body 100, 140, 150, and 170A-G is then selected to best fill the space or
the desired portion of the space.
In various embodiments as explained below with reference to FIGS.
11A-F and 15A-F, the expandable body 100 or 140 is positioned within the saccular
aneurysm and inflated to an expanded state. In this ment, the expandable body
100 or 140 is dimensioned to have an expanded width or diameter (as measured
transverse to the axis extending from the al nose cone 3628 to the distal nose
cone 362A) that is greater than the width of the g 703 of the aneurysm from the
parent vessel 1202. After inflation or ion, the expandable body 100 or 140 is
retracted towards the opening 703 of the aneurysm, and a coil or accessory coil 162, as
shown in FIGS. 11E and 15E, is delivered through the delivery catheter and also
through the expandable body 100 or 140 and positioned within the aneurysm 700 in the
region of the dome 701 via the distal neck 118. The accessory coil 162 contacts both
the inner surface 704 of the wall of the aneurysm 700, as shown in FIGS. 11E and 15E,
and the al surface of the expandable body 100 or 140, including the distal surface
of the expandable body. The accessory coil 162 exerts a force against the expandable
body 100 or 140 to push the expandable body against the opening 703 of the aneurysm
700. In one embodiment, the accessory coil may be slightly magnetic such that it is
attracted to and stays in contact with the expandable body 100 or 140, without
undesirable biological or physiological effects.
As shown in F, and 178, the expandable body 100, in
ction with the accessory coil 162, function similar to a poppet valve to seal the
aneurysm opening 703. In particular, the able body ons like a plug that
covers the aneurysm opening 703, while the accessory coil 162 functions as a spring to
apply nt force on the expandable body 100.
In various embodiments, the accessory coil 162 is composed of nitinol.
In one aspect, the accessory coil 162 may be formed from wires having a diameter in
the range of approximately 0.05 mm to approximately 0.20 mm. The nitinol wires may
r be coated with a polymer 161, including but not d to PTFE, as shown in
. In one aspect, the coated nitinol wires or fibers of the ory coil 162 may
include an end-cap 163, including a polymeric end-cap, as shown in FIGS. 3A, to
minimize the ial for injury to aneurysm surface or other vessels traversed by the
coil. The coating and the end caps may also reduce friction when inserting the coil with
an accessory coil delivery catheter 3528, as shown in In various embodiments,
the accessory coil 162 may have a diameter in a range between approximately 0.002
and 0.012 . Preferably, the accessory coil 162 has a diameter between
approximately 0.004 and 0.008 . Similarly, the polymer coating 161 on the
accessory coil 162 may have a thickness in a range between approximately 0.001 and
0.003 . Preferably, the polymer coating has a thickness between approximately
0.0015 and 0.002 inches. The coil delivery catheter 3528 may have an outer diameter
in a range between approximately 0.014 and 0.022 inches, and preferably, an outer
diameter n approximately 0.016 and 0.020 inches. Similarly, the coil delivery
catheter 3528 may have an inner diameter in a range between approximately 0.008 and
0.016 inches, and preferably, an inner er between imately 0.010 and
0.014 inches.
In one embodiment, the accessory coil is delivered into the aneurysm
and allowed to fill the void in the aneurysm not occupied by the expandable body. In
another embodiment, the accessory coil is pre-formed into a spherical shape having
dimensions X1 x Y1 as shown in FIGS. 12A or is pre-formed into an oval shape having
dimensions X1 x Y1 or X2 x Y2, as shown in FIGS. 128. By way of example, the
accessory coil 162 may be formed into an imately 8 mm diameter ball or an
approximately 8 mm x 4 mm spheroid. In other examples, the accessory coil may be
configured into three-dimensional construct having a volume between approximately 50
mm3 and 300 mm3.
Forming the Expandable Body
In an exemplary method of forming the expandable body 100, 140,
150, or 170A-G, the central layer 122 of the wall 102 may be formed by vapor
deposition, wherein vapors from one or more polymers, pure metals, metal alloys, or
layers thereof, are condensed upon a substrate or mold (e.g., mandrel). The mold may
be removed to e a hollow shell formed of the pure metal or metal alloy.
In a preferred embodiment, the central layer 122 of the wall 102 is
formed by electroforming or electroplating a metallic shell over a removable form or
mold (e.g., mandrel). For example, as shown in FIGS. 25A-C, a multi-part mandrel
3200 for electroforming the expandable body 100, 140, 150, or 170A-G is shown in
l cross-section. The mandrel 3200 includes a steel base 3202 and form member
3204 that is removable from the base. Preferably, the form member 3204 is composed
ofa rigid material, ing but not limited to aluminum or stainless steel. Although
shown as a sphere, other embodiments of the form member 3204 may be other shapes,
ing but not limited to the shape of a lly pleated or partially folded body 3204
that results in an expandable body 100, 140, 150, or 170A-G having a configuration
intermediate to the deliverable (i.e., fully collapsed or pleated and folded) uration
and the fully expanded uration, such a partially pleated mandrel 3204 being
depicted in . In addition, the protrusions 1800, as shown in FIGS. 18G-H, may
be fashioned onto the form member 3204, such that the protrusions 1800 are formed
during the electroforming or electroplating process. The form member 3204 may be
spherical as shown in FIGS. 25A-B and 27 to form a spherical expandable body 100, or
150. rly, the form member 3204 may be oblong, a cylindrical body having
hemispherical ends, or any other shape to form the expandable bodies 140 and 170A-
G. In various embodiments, the mandrel 3200 or at least the removable form 3204 is
sacrificial, such that it is consumed during the process of g the expandable body
100, 140, 150, or 170A-G.
To form a metal expandable body, the form member 3204 is removed
from the base 3202. A portion of the form member 3204 may be threaded so that it can
engage a threaded spindle 3206 extending from the base 3202. After the form member
3204 is ed from the base 3202, a metallic ring 3208 is positioned on the threaded
spindle 3206. In one embodiment shown in , the threaded spindle 3206 includes
a shoulder 3212 that has a diameter greater than that of the threaded spindle 3206,
such that the metallic ring 3208 can be seated in a desired position.
The metallic ring 3208 is a non-sacrificial component of the mandrel
3200. In one ment, the ic ring 3208 is any biocompatible metal that is
reactive to electrolysis. For example, the metallic ring 3208 may be composed of gold,
316L stainless steel, or 304 stainless steel. Preferably, the metallic ring comprises 304
stainless steel, as 304 stainless steel has lower nickel content than 316L stainless steel
and will minimize the risk of cytotoxicity during electrolysis. In some embodiments, 304
stainless steel is preferred as it has a pitting potential (approximately 0.18 V - 0.38 V
relative to a reference electrode) that is lower than the hydrolysis potential of water
(approximately 0.82 V). Therefore, electrolysis with 304 stainless steel may be
performed under more controlled conditions with more repeatable results than
electrolysis performed with 316L stainless steel or gold, whose g potentials
(approximately 0.98 V - 1.18 V and approximately 0.7 V - 0.9 V, respectively) exceed
the hydrolysis potential of water.
In various embodiments, the metallic ring 3208 is between
approximately 0.025 inches and approximately 0.150 inches in length, with a wall that is
between approximately 25.4 um and approximately 254 pm thick. In one embodiment,
the metallic ring 3208 is 0.05 inches in . A gold plating or g may optionally
be applied to at least a portion 3210 of the ic ring 3208 to encourage the
deposition of gold that will be used to form a gold expandable body. Similarly, a plating
or coating composed of another metal, including but not limited to platinum, may be
used to encourage the deposit of the other metal. As such, the ic ring 3208 will
be integrated into the expandable body 100, 140, 150, or 170A-G and form all or a
n of the neck 116 or 118 of the expandable body. A nductive polymerjoint
may be placed n the neck 116 or 118 and the rounded body portion of the
expandable body 100. This joint will provide additional flexibility to the expandable body
100, as well as further insulating the expandable body from the electrolysis current used
to detach various embodiments of the expandable body.
Once the metallic ring 3208 and the form member 3204 are positioned
on the threaded spindle 3206, the mandrel 3200 is placed in an electrolyte bath (not
shown) containing metallic ions, such as gold, where the gold ions are deposited on the
form member and at least a portion of the metallic ring 3208. In particular, the mandrel
3200 is positioned such that the expandable body 100, 140, 150, or 170A-G is
electroformed over the form member 3204 and the portion of the metallic ring 3208
having the gold flash, thereby bonding the metallic ring to the expandable body. In
some embodiments, a portion of the metallic ring 3208 is not coated by gold, including
methods that use masking before electroforming.
In various embodiments and as can be understood from FIGS. 16A-D,
the thickness 120 of the ent wall 102 can be controlled by varying the
oforming process. For example, by adjusting the duration of the electroforming
process, walls of greater or lesser thickness may be . Similarly, the wall
ess 120 may be varied in certain locations by applying one or more masks to the
mandrel 3200. In addition, the on of the mandrel 3200 relative to the anode in the
solution bath will also affect the ess of the wall. For example, an internal feature
at the neck of the expandable body 100, 140, 150, or 170A-G may have a thinner wall
than the rounded spherical portion of the expandable body. The expandable body 100,
140, 150, or 170A-G may be formed intentionally with a thinner, and therefore ,
neck region that can be d to separate the expandable body from the neck 116,
including a neck that es the metallic ring 3208. Alternatively or additionally, a
stress concentration ring in the form of a line or strip may be defined in the neck or in
the proximal portion 208 of the expandable body 100, 140, 150, or 170A-G, more
ically, a ring-shaped region of exposed metal (e.g., stainless steel portion of the
ring 3208 or a gold portion of the neck 116) to help facilitate separation of the delivery
device or catheter from the expanded expandable body at the ring-shaped region of the
exposed metal. Such a stress concentration line may be formed into the ring-shaped
region of the d metal by various methods including by laser etching, by s
mechanical ions such as sawing or grinding, or by electrolysis.
After formation, the expandable body 100, 140, 150, or 170A-G and
the form member 3204 are removed from the mandrel base 3202, where the form
member is removed to leave only the metallic ring 3208, which may form all or a portion
of a the proximal neck and the der of the expandable body, which may include
the main body and optionally a distal neck, as shown in a partial cross-section in . In one embodiment, the aluminum form member 3204 is removed though the neck
116 by chemical and/or thermal leaching or etching. In another embodiment, a hole is
drilled into the aluminum form member 3204 though the neck 116 by mechanical
operations, such as, but not limited to, drilling with an auger bit. The hole may be used
to accelerate and regulate the chemical g process to remove the aluminum form
member 3204 from the expandable body 100, 140, 150, or 170A-G. Preferably,
combinations of mechanical, chemical, and thermal methods are used to ensure that all
of the constituents of the form member 3204 are removed. It is desirable to completely
remove the form member 3204 from the expandable body 100, 140, 150, or 170A-G to
ensure sufficient plasticity or malleability of the able body and to ze any
toxic effects after implantation, such as may be the case specifically when the
expandable body comprises residual aluminum.
To reduce the presence of stress concentrations regions or surface
variations of the expandable body 100, 140, 150, or 170A-G and to eliminate the
transfer of concentric e marks from the form member 3204, the mandrel 3200
and in particular the form member may be polished or lapped before electroforming the
expandable body. An unpolished form member 3204 and a resulting gold expandable
body 100, 140, 150, or 170A-G are shown in FIGS. 29A and 298, respectively.
Conversely, a polished form member 3204 having a lapped finish and the resulting gold
expandable body 100, 140, 150, or 170A-G are shown in FIGS. 29C and 29D,
respectively. In one embodiment, polishing the form member 3204 reduces the
ce between the t and lowest points of surface imperfections or features to
approximately 0.1 pm or less.
WO 46001
Once the form member 3204 has been removed from the expandable
body 100, 140, 150, or 170A-G, the able body may undergo an annealing
process to improve the pliability of the expandable body. In one embodiment, the
expandable body is heated to approximately 300° C for approximately 1 hour and then
immediately quenched in a bath ofdistilled water at room temperature. In other
embodiments, the expandable body 100, 140, 150, or 170A-G is folded or ise
deformed after a first annealing process and then subjected to one or more additional
annealing processes. In further embodiments, the expandable body 100, 140, 150, or
170A-G is coated on the external surface, including coating with a polymer such as
ne, and then subjected to one or more annealing processes.
The interior and exterior surfaces of the expandable body 100, 140,
150, or 170A-G may be cleaned to remove any contaminants ing from
manufacture. For example, in one embodiment, the expandable body 100, 140, 150, or
170A-G is placed in an ultrasonic cleaner that ns an isopropyl alcohol bath for
approximately 10 minutes. The expandable body 100, 140, 150, or 170A-G is then
removed from the bath and injected with led water to remove any contaminants
remaining in the interior of the able body. Optionally, the expandable body 100,
140, 150, or 170A-G may be dried in a vacuum oven held at approximately 90° C. In
various embodiments, the exterior surface, and optionally the interior surface, of the
expandable body may be plated with platinum to reduce the potential for undesired
reactivity with a patient during deployment, including to reduce the potential for
electrolysis on the surface of the main body or distal neck of the expanded expandable
body.
As shown in FIGS. 16D, 30A, and 308, the exterior surface 110 of the
ballstent 100, the interior surface 106, or both can be coated with a polymer such as
Parylene or an acrylic polymer. The polymer can be added by incorporating a pre-
formed material into the desired orientation, by vapor tion, or other methods. In
some embodiments, at least a n of the neck 116 or the interior surface 3304 of the
metallic ring 3208 is not coated. In one embodiment, the ballstent 100 may be
annealed, as previously bed, at least once after the application of the tallic
coafing.
In embodiments of the expandable body 100, 140, 150, or 170A-G
where the wall 102 is composed of a al that his highly non-reactive during
electrolysis, such as platinum, the interior and exterior of the neck 116 or 118 may be
coated, while the remaining surfaces are not coated. Similarly, in some embodiments
where the expandable body 100, 140, 150, or 170A-G will be detached by an operation
other than electrolysis, only the interior surface 106 may be coated with the non-metallic
In some embodiments, after coating, a portion of the polymer coating is
removed from the exterior surface 3300 to expose the metal surface in a strip or ring
configuration, as shown in FIGS. 3OC-F. In other ments, the exposed metal
surface may be formed by masking this region before coating, and then removing the
masking material. Electrolysis can be used to separate the expanded expandable body
from the remainder of the neck 3300 and the delivery catheter at the region comprising
the exposed metal surface. The width W of the detachment site (i.e. the exposed metal
surface in a strip or ring configuration) 3302 may be in a range between about 0.1 mm
and about 0.4 mm. The detachment site W may be located anywhere along the length
N1 of the neck 116. In some embodiments W may be located in the region of the neck
formed by the metallic ring 3208. In one particular embodiment, the d strip of the
detachment site 3302 has a width W of 0.25 mm 1r 0.03 mm and is located at a length
N5 of approximately 0.51 mm 1r 0.03 mm from the end of the neck 116. The metallic
strip may be exposed by any suitable , including but not limited to laser etching
or laser ablation. In other embodiments, the ic strip of the detachment site 3302
may be exposed before or after the g or compression of the expandable body 100,
140, 150, or 170A-G. By way of example and not limitation, in one embodiment, the
exposed metal in the region 3302 is gold, while in other embodiments the exposed
metal is stainless steel.
In various embodiments, the wall 102 of the expandable body 100,
140, 150, or 170A-G is perforated to create a plurality of microperforations 1300, as
shown in 8. By way of example and not limitation, the erforations 1300
may be created by laser perforating the wall 102. The microperforations 1300 or pores
may range from imately 1 pm to approximately 500 pm in diameter and may
extend completely through the thickness of the wall 1022 from the interior void 108 to
the or surface 110. Alternatively, a microperforated expandable body 100, 140,
150, or 170A-G may be formed during the electroforming process, such as with the use
of a masking pattern.
After perforating, the expandable body es 110 and 106 may be
coated with a polymer that does not completely cover the microperforations 1300,
thereby leaving channels between the inner and outer surfaces. ately, the
expandable body 100, 140, 150, or 170A-G may be laser perforated after coating. The
erforations 1300 permit the exchange of fluid between the interior void 108 of the
expandable body 100, 140, 150, or 170A-G and the environment exterior to the
expandable body.
In various embodiments, as shown in FIGS. 16C-D, the exterior layer
104 may be formed on the outside of the l layer 122 of the expandable body 100,
140, 150, or 170A-G by additional electroplating or electroforming, by vapor deposition,
or by sputter deposition, wherein material is eroded from a target (e.g., a metal or metal
alloy) and is then deposited onto a substrate (e.g., a mandrel or mold) forming a thin
layer on the substrate. Similarly, an interior layer 214 may be formed on the inside of
the l layer 122 of the expandable body 100, 140, 150, or 170A-G by additional
electroplating or electroforming, or by vapor deposition, or by sputter deposition.
In various ments, an additional polymer coating is applied to the
expandable body 100, 140, 150, or 170A-G to modify the strength and flexibility
characteristics of the wall 102. For example, r may be applied via dip, spin, or
spray coating, or through deposition processes specialized for the specific polymer to
provide additional strength or flexibility to the wall. The additional coating may be
Parylene, biocompatible polyurethanes, PTFE, and silicone, among others. In one
embodiment, this coating can be limited to the neck 116 or 118 of the expandable body
100, 140, 150, or 170A-G by using a mechanical or chemical template. In various
WO 46001
embodiments, detailed geometries and designs can be laser etched into the
reinforcement coating to further optimize the wall properties with the folding geometry.
r, the removal of the reinforcement coating in regions where it is not needed
would also remove unnecessary material from the final diameter of the collapsed and
wrapped expandable body 100, 140, 150, or 170A-G.
The wall 102 of the main body of the expandable body 100, 140, 150,
or 170A-G may be formed by different methods than the neck 116. As shown in FIGS.
16C-D, the central layer 122 of the expandable body 100, 140, 150, or 170A-G may be
formed by different methods than the exterior layer or coating 104 or the interior layer or
coating 214. In various other ments, the expandable body 100, 140, 150, or
170A-G may be formed by manipulating and securing one or more sheets of metal in
the desired configuration to form the wall 102 and/or the exterior layer 104. These two-
ional sheets may further comprise rubber, plastic, polymer, woven or knitted fiber
materials, or other materials, or combinations thereof. By way of example and not
limitation, one or more two-dimensional sheets of a metal may be folded into an
expandable body shape and welded, soldered, glued, or bonded together. rly,
mensional sheets of material may be manipulated and secured to form the
exterior layer 104 or the interior layer 214.
In another embodiment, a stainless steel (SST) ring 250, as shown in
FIGS. 2A, 28, 5A, and 5B is attached to the proximal neck 116 via welding after the
formation of the expandable body 100, 140, 150, or 170A-G. In other embodiments, the
entire neck 116 may be stainless steel and may be incorporated during the formation of
the expandable body or subsequently welded to the body. The SST ring 250 or the
SST neck 116 may be composed of any biocompatible ess steel alloy, including
but not limited to 300 series stainless steel or 400 series stainless steel and preferably
304, 316, 316L, or 316LVM stainless steel.
The SST ring 250 may be subjected to one or more heat-treating
processes to make the SST ring more sensitive to the ic corrosion caused by
electrolysis. Therefore, the reating processes allow the SST ring 250 to be
severed more easily thereby decreasing the time necessary to detach the expandable
body from the delivery catheter. In one aspect, the SST ring is heated by laser etching
the surface of the SST ring. The SST ring 250 is also heated by the welding s to
attach the ring to the proximal neck 116. It is believed that the heating processes of
welding or laser etching can sensitize the SST ring 250 to the galvanic corrosion of
electrolysis.
In one embodiment, the SST ring 250 may be included in an elongated
electrolysis segment 260, as shown in FIGS. 2A-B, 2D-l, 2K-N, 2P-Q, 6A-D, 8G-K, 8P,
108, and 148. In this embodiment, the electrolysis segment 260 is a coil segment,
r to a catheter or guide wire that is attached to the distal portion of a delivery
er 400 that has been modified to include a cathode ring 262 and at least a portion
of the SST ring 250 that serves as the anode for electrolysis. Similar to the thermoset
polymer segment 1020, described below with reference to FIGS. 23H-l, the electrolysis
segment 260 es an insulating coating 264 that separates a ring cathode electrode
262 and the SST ring anode 250. In another embodiment, the electrolysis segment 260
may be fabricated independently and then affixed to the delivery catheter 400 using any
le method. By way of example and not limitation, the methods to affix the
electrolysis segment 260 to the ry catheter 400 may e welds, solder, or an
The Delivem Device
The expandable body 100, 140, 150, or 170A-G is advanced and
positioned within human body by an elongated portion of the medical device known as
the “delivery device” or ery catheter”, with delivery catheter used particularly when
the elongated portion of the medical device is flexible. In one ment, a delivery
device is an ted medical device that defines at least one lumen, or potential
lumen. The delivery device has a proximal and a distal end and is dimensioned to
deliver a fluid medium from a fluid medium source at the proximal end of the device into
the central void or space 108 of the expandable body 100, 140, 150, or 170A-G, which
is attached or coupled to the distal end of the delivery device. Further, any medical
device or component of a medical device that can position the expandable body 100,
140, 150, or 170A-G at a desired location in the vascular system, such as the lumen of
a saccular aneurysm or lumen of a target blood vessel, facilitate the expansion of the
able body, and then facilitate the separation of the expandable body from the
ry device is generally acceptable as a delivery . Typically, the delivery
device is a flexible catheter (a “delivery catheter”). Preferably, the ry catheter may
be any flexible catheter, hollow wire, removable core wire, or combinations thereof,
suitable for ing locations with the vascular system including the delivery
catheters 300, 352A-B, and 400, shown in FIGS. 7, 9, and 13. The delivery device may
also be any other type of catheter, hollow wire, or removable core wire, or alternatively a
needle or trochar, a stylet, or combinations thereof, suitable for accessing locations
within the vascular system or in other ical conduits. In various embodiments, the
delivery device is a catheter 300, 352A-B, or 400 that can carry an ed
ssed expandable body 100, 140, 150, or 170A-G to the lumen of a saccular
aneurysm or the lumen of a target artery or vein, or other form of biological conduit.
A catheter is a flexible, tubular, elongate medical device configured for
insertion into bodily compartments, including blood s, to permit the injection or the
withdrawal of fluids, t other functions. Catheters are often formed of polymers
or plastics and optionally further include metal, such as in a coil or braid uration
for reinforcement. Catheters can be configured to enable attachment to expandable
bodies 100, 140, 150, or 170A-G, facilitate the delivery of ssed expandable
bodies to the lumen of an aneurysm sac or lumen of a target blood vessel or other
biological conduit, facilitate the inflation or expansion of compressed expandable
bodies, and separate from expanded expandable bodies. In some embodiments, the
delivery catheter 300, 352A-B, or 400 can be configured to pass through the vascular
system with the attached expandable body 100, 140, 150, or 170A-G in a compressed
form, as shown in FIGS. 10A and 17A. After expansion, the expandable body 100, 140,
150, or 170A-G is separated from the ry catheter 300, 352A-B, or 400, thereby
allowing the expanded expandable body to remain in place while the delivery catheter is
removed from the body. In this way, delivery catheters are similar to angioplasty
balloon catheters, which are configured to enable ment to traditional rigid tubular
stents, to facilitate the delivery of ed compressed traditional tubular stents to the
lumen of a specific segment of a blood vessel or other biological conduit, enable
expansion of compressed traditional tubular stents, and separate from expanded
traditional tubular stents.
The delivery catheter 300, 352A-B, or 400 is composed of a
biocompatible al. By way of example and not limitation, the delivery er 300,
352A-B, or 400 and various components thereof may be formed of silicone rubber,
natural rubber, polyvinyl chlorides, polyurethane, copolyester polymers, thermoplastic
rubbers, silicone-polycarbonate copolymers, polyethylene ethyl-vinyl-acetate
copolymers, woven polyester fibers, or combinations thereof. In one ment, the
wall of the delivery catheter 300, 352A-B, or 400 may be reinforced with a metal, such
as coiled or braided stainless steel or nitinol, to enhance control and reduce kinking of
the delivery catheter during use. Metals suitable for delivery er reinforcement
include stainless steel and l.
As shown in FIGS. 7, 9, 10A-B, 13, 14A-B and 23A-B, the delivery
catheters 300, 352A-B, or 400 will have a , or potentially hollow, cylindrical
member that defines a lumen to allow for passage of a fluid medium from the proximal
end of the delivery catheter to the distal end of the delivery catheter and into the central
void 108 of the expandable body. The delivery catheter, 352A-B, or is designed and
ioned such that it can be inserted in the body to deliver the compressed
expandable body 100, 140, 150, or 170A-G to a d location, facilitate the inflation
or expansion of the expandable body, and facilitate the tion of the expanded
expandable body from the delivery catheter. When a single lumen delivery catheter
300, 352A-B, or 400 is used, the compressed expandable body may be oned in
the lumen of a saccular aneurysm or lumen of the target blood vessel after being
ed through a separate larger catheter, guide catheter, or guide sheath that is
positioned with its distal end within or near the aneurysm or target location within the
target blood vessel. Once in the lumen of the aneurysm sac or lumen of the target
blood vessel and out of the guide catheter, the compressed able body 100, 140,
150, or 170A-G can be expanded, and then the expanded expandable body and the
delivery catheter 300, 352A-B, or 400 can be separated, and the delivery catheter and
the guide er can be removed from the body, while the ed expandable body
remains in place. The hollow, or potentially hollow, cylindrical member 306 of ry
catheter 300, 352A-B, or 400 has a wall thickness ranging from about 0.05 mm to about
0.25 mm. Preferably, wall thickness of the hollow cylindrical member 306 ranges from
about 0.1 mm to about 0.2 mm. The lumen 312 defined by the hollow cylindrical
member 306 for the purpose of enabling the passage of a fluid medium into the central
void or space of the expandable body 108 has a diameter ranging from about 0.4 mm to
about 1 mm. The proximal end of the hollow cylindrical member 306 includes a port or
hub 3408 to communicate with a pressurized fluid medium , such as a e
314 or a pump (not shown) containing, for example, water, saline or a radiographic
contrast solution. The fluid media for expanding the expandable body are received into
the delivery catheter 300, 352A-B, or 400 through the hub or port 3408.
Single Lumen Catheters
depicts a longitudinal view of a single lumen embodiment of the
delivery catheter portion 400 of the medical device 500, and A depicts a
erse cross-section of the single lumen catheter. As shown in FIGS. 11A-F, for the
single lumen embodiment, the delivery catheter 400 moves through the lumen of a
guide catheter 800 to deliver the compressed ballstent 100 to the lumen 701 of a
saccular aneurysm 700. For this single lumen embodiment, the delivery catheter 400
does not include a hollow cylindrical member that defines a lumen that is ioned
to allow for the passage of a ce , or guide wire.
The dimensions of the delivery catheter 300, 352A-B, or 400 are a
matter of design choice depending upon the size of aneurysm to be treated and the
location of the aneurysm in the vascular system. The distance n the aneurysm
to be treated and the site of insertion of the medical device into the vascular system, will
determine, in part, the length of the delivery catheter 300, 352A-B, or 400. Delivery
catheter lengths range n about 5 cm and about 300 cm, with preferable ranges
n about 75 cm and about 225 cm. The smallest diameter blood vessel segment
in the path between the site of insertion of the medical device into the vascular system
and the aneurysm to be d will determine, in part, the diameter of the delivery
catheter 300, , or 400. Delivery catheter diameters range between 2 Fr and 7
Fr, with preferable ranges between 2 Fr and 5 Fr.
FIGS. 10A-B depict longitudinal views of a single lumen embodiment of
the delivery catheter 400 portion of a medical device 500. A depicts a
longitudinal view of a single lumen embodiment of the l device 500 with the
ballstent 100 in a compressed form. B depicts a longitudinal view of a single
lumen ment of the medical device 500 with the ballstent 100 in an expanded
form.
In some embodiments, as shown in FIGS. 10A-B, the proximal end of
the delivery catheter 400 is configured with a hub 3408 that may facilitate a Luer-Lok or
Luer-Slip type connection for connecting a fluid medium , such as a syringe 314,
to the lumen 312 of a hollow cylindrical member configured to transmit the fluid medium
from the proximal end of the delivery catheter to the central void or space of the
expandable body 100, 140, 150, or 170A-G. As shown, in , the lumen 312 ofa
delivery er 400 is connected to a fluid medium source, such as the syringe 314,
through a female Luer fitting 2802. A stopcock 2804 or flow switch may be positioned
between the fluid medium source and the delivery er 400 to enable greater l
over the movement of the fluid medium into and out of the delivery catheter.
As shown in E, in one embodiment single lumen delivery
catheter can be used to place a ballstent 100 in the lumen 701 of the aneurysm sac
700, For this embodiment, an optional removable wire or obturator 404 is removed from
the delivery catheter. The removable wire or obturator 404 may include a handle 408 or
other device to facilitate insertion and removal. Then, a fluid medium , such as
the syringe 314 can be connected to the hub 3408 and a fluid medium can be moved
from the syringe 314 into the central void or space 108 of the ballstent 100 under
pressure, resulting in inflation or expansion of the ballstent within the lumen 701 of the
aneurysm sac 700 and filling substantially all or a portion of the aneurysm sac. Fluid
media such as water (including deionized water), saline, solutions of radiographic
contrast , or solutions of drugs, such as thrombin, can be used to expand the
2014/030869
ssed ent 100. As shown in E, after inflation or expansion of the
ballstent 100, a coil, accessory coil, ile wire, or expansile structure 1204 can be
placed into the central void of the ballstent 100.
A variety of methods and devices can be used to separate the delivery
catheter 400 from the ballstent, blockstent, or expandable body. In one embodiment as
indicated in FIGS. 9, 10A-B, and 23A, the delivery er 300 or 400 comprises one or
more electrolysis wire(s) 320 or insulated conductor wire(s). For this embodiment, after
the ballstent 100 is expanded, an electrical current is applied to the electrolysis wire(s)
320 or the ted conductor wire(s) to dissolve a portion of the proximal neck of the
ballstent 100 by electrolysis ding a stainless steel portion). In ative
embodiments, the electrical current may be applied to dissolve a portion of a ess
steel ring 250 between the ballstent 100 and the delivery catheter 300 or 400 or to
dissolve a portion of the proximal region of the ballstent 100 by electrolysis. A direct
current (DC) may be used for any of these embodiments. Once a portion of the
al neck, stainless steel ring 250, or proximal region of the ballstent 100 is
dissolved or corroded, the delivery catheter 300 or 400 is separated from the expanded
ballstent and the ry catheter and the guide catheter 800 are removed.
In various embodiment as illustrated in FIGS. 2BB-C, a single
lumen catheter 1000 has a coil-reinforced wall 1002 consisting of one, two, or three
electrical conductor (e.g., wires or cables) to provide conductive path(s) for ming
electrolysis, as explained more fully below. In one embodiment, the external surface
1004 of the wall 1002 is composed of polyimide and has a hydrophilic or lubricious
coating, while the conductive path(s) includes 0.001 inch x 0.003 inch flat stainless steel
coils 1006. The conductor coil(s) 1006 can be configured in a one, two, or three
conductor arrangement 1008 as shown in FIGS. 2BB-F, as discussed below with regard
to performing electrolysis. The conductors of the coil 1006 and any other conductors
may be straight, braided, or coiled. The conductive path defined by the conductor coils
1006 can be coated in an insulating polymer such as Parylene, while the interior lumen
1012 can be lined with PTFE, ing a PTFE composite.
In certain embodiments, a modified infusion wire having a removable
core can be used as a single lumen delivery catheter. An infusion wire is a modified
guide wire wherein the solid metal core can be removed to leave a lumen that can be
used to inject the fluid media. An infusion wire with a removable core can be modified
such that an expandable body 100, 140, 150, or 170A-G can be attached to the distal
end and expanded through the wire lumen, after the removal of the core wire.
In some ments all or a portion of the interior and exterior
es of the delivery device can be further coated with a hydrophilic or lubricious
coating. In other embodiments, all or a portion of the expandable body 100, 140, 150,
or 170A-G can also be coated with a hydrophilic or lubricious coating.
Dual Lumen Catheters
As shown in and 8, the delivery catheter 300 may
e an additional hollow cylindrical member that defines a second lumen 324 to
e a guidance member, such as a guide wire 302, to assist in the guidance of the
ballstent 100 component of the medical device to the desired location, as can be
understood from FIGS. 14A-B and 15A-F. This second lumen 324 is generally nt
and parallel to the first lumen 312. As shown in FIGS. 13 and 208, the delivery catheter
300 may be a double lumen catheter, with one lumen 312 configured to enable the
passage of the fluid medium from a fluid medium source at the proximal end of the
delivery catheter to the central void or space 108 of the ballstent at the distal end of the
delivery catheter, and the other lumen 324 configured to accept a guidance member,
such as a guide wire 302, to tate advancement and oning of the medical
device in the vascular system. In certain embodiments, the distal end of the lumen 324
configured to accept a guidance member may be defined by a bridging catheter, similar
to the bridging catheter 160 as shown in FIGS. ZB-C, 2E, 2G, 2L-N, ZO-P, 8H, 8J-O,
and 8R-S, either as a part of the delivery catheter that passes from the proximal hub to
the distal end of the delivery catheter, or as a distinct element coupled or bonded to the
distal end of the ry catheter. As described previously, this guidance er can
pass through the al neck, through the void of the expandable body, and
operatively couple to the distal neck, such that a guide wire, guidance member, coil,
accessory coil, or accessory coil catheter can be passed through the hub of the ry
catheter and out the distal end of the medical device, including for positioning of a guide
wire or guidance member in an artery, vein or other biological conduit and also including
for placement of a coil or accessory coil in the lumen of a saccular sm.
As shown in 8, the delivery catheter 300 includes two hollow
cylindrical members, each with a lumen, wherein the hollow cylindrical members 304 or
306 have a wall thickness ranging from about 0.05 mm to about 0.25 mm. Preferably,
the hollow cylindrical member 304 or 306 wall thickness ranges from about 0.1 mm to
about 0.2 mm. The lumen d by the hollow rical member 304 for the
accepting a guide wire 302 has a diameter ranging from about 0.25 mm to about 0.5
mm. The diameter of the lumen for the passage of the fluid medium into the ballstent
100 and the diameter of the lumen for accepting a guidance member 324 may be
similarly dimensioned. Alternatively, the diameter of the lumen for the passage of the
fluid medium into the ballstent, blockstent, or expandable member may be larger or
smaller than the diameter of the lumen for accepting a guidance member, such as the
guide wire 302 or for accepting a coil, ory coil, or accessory coil er.
For a ry catheter with two lumens, the first and second hollow
cylindrical members may be similarly dimensioned. Alternatively, the second hollow
cylindrical member may have a larger diameter to accept the guide wire, guidance
member, coil, accessory coil, or accessory coil catheter, or a smaller diameter. The
proximal end of the second hollow cylindrical member 304 is engaged to the hub 3408.
The hub 3408 facilitates the insertion of the guide wire 302, guidance member, coil,
accessory coil, or accessory coil catheter into the second hollow rical member
304. As can be understood from FIGS. 13, 14A-B, 15A-F, and 208, in some
embodiments the guide wire 302, ce member, coil, accessory coil, or accessory
coil catheter can be fed through the second hollow rical member 304 and
extended out of the distal end of the delivery catheter 300, and also out the distal end of
the medical device. In other embodiments, including those embodiments lacking a
bridging catheter component, the coil, accessory coil, or accessory coil er can be
fed through the second hollow cylindrical member 304 and placed in the central void of
the ballstent, blockstent, or expandable body. In some of the embodiments with a
double lumen delivery catheter, the delivery catheter 300 is advanced over the guide
wire 302 until the compressed ballstent 140 is oned in the lumen of a saccular
aneurysm. Once the compressed ballstent 140 is in the desired position, the ballstent
140 is expanded by the fluid medium provided to the first hollow cylindrical member 306
by the syringe 314 connected to the ballstent expansion hub 3408. Fluid media such as
water, saline, solutions of radiographic contrast agents, or solutions of drugs, such as
thrombin, can be used to expand the compressed ballstent. The guide wire 302 is
preferably an angiographic wire of sufficient length for the distal tip of the guide wire to
reach the aneurysm, and a al end extending out and away from the point of entry
into the vascular system. In some embodiments, the guide wire 302 has a straight or
angled distal tip, while in other embodiments, the guide wire 302 has a curved J-shaped
distal tip, typically constructed from a shape-memory alloy or a d metal that
causes the tip to return to the J-shape after any applied stress is removed. The
materials and dimensions of the guide wire 302 may be selected based upon the
er, length, and tortuosity of the blood vessels being traversed. Typically, the
guide wire 302 may be composed of any suitable biocompatible materials and have an
outer er ranging between about 0.3 mm to about 0.95 mm.
FIGS. 14A-B depict longitudinal views of a double lumen embodiment
of the delivery catheter portion 300 of the medical device 500. A depicts a
longitudinal view of a double lumen ment of the medical device 500 with the
expandable body 140 in a ssed form, while B depicts a longitudinal view
of a double lumen ment of the medical device 500 with the ballstent 140 in an
expanded form. The delivery catheter 300 is used to advance the ballstent 140 over a
guide wire 302 and into the lumen of the aneurysm sac. The delivery catheter 300 is
also used to deliver a fluid, liquid, gas, solid, or a combination thereof, to expand the
ballstent 140 in the lumen 701 of the aneurysm sac 700. In some embodiments, the
ry er 300 or 400 comprises one or more electrolysis wire(s) 320 or insulated
conductor wire(s). For these ments, after the ballstent 100 is expanded, an
electrical current is applied to the electrolysis wire(s) 320 or the insulated conductor
2014/030869
wire(s) to dissolve a portion of the proximal neck of the ballstent 100 by electrolysis
(including a stainless steel portion. In alternative embodiments, the electrical current
may be applied to dissolve a portion of a ess steel ring 250 between the ballstent
100 and the delivery catheter 300 or 400 or to dissolve a portion of the proximal region
of the ballstent 100 by electrolysis. A direct current (DC) may be used for any of these
embodiments. . Once a portion of the proximal neck, stainless steel ring 250, or
proximal region of the ballstent 100 is dissolved or corroded, the delivery catheter 300
or 400 is separated from the expanded ballstent and the delivery catheter and the guide
catheter 800 are d.
In one embodiment, an electrolysis wire 320 or an insulated conductor
wire is connected or electrically d to a n of the proximal neck of the
ballstent, including at an exposed metal surface 3302. In another embodiment, an
electrolysis wire 320 or an insulated conductor wire is ted or electrically coupled
to a weld, solder, or other form of bonding between the ballstent and the delivery
catheter, including an ve. In another embodiment, an electrolysis wire 320 or an
insulated conductor wire is connected or electrically d to another portion of the
ballstent 140, also including at an exposed metal surface 3302.
As shown in FIGS. 10A-B, 13, 14A-B, and 15A-F, in one embodiment
of the medical device 500, the delivery catheter 300 or 400 advances the attached
ssed ballstent 100 or 140 over a guide wire 302 and into the lumen or cavity 701
of the aneurysm sac 700. Once the compressed ballstent 100 or 140 has been placed
in the lumen 701 of the aneurysm sac 700, the guide wire 302 is removed. Then, a fluid
medium source, such as the syringe 314 is connected to the hub 3408 and a fluid
medium is moved from the syringe 314 into the central void or space 108 of the
ballstent 100 or 140 resulting in expansion of the ent until it fills at least a portion of
the lumen of the aneurysm sac 701. After inflation or expansion, the delivery catheter
300 or 400 is pulled to back in the aneurysm sac 700 to pull the expanded expandable
body 100 or 140 s the opening 703 n the parent vessel and the aneurysm,
including toward the neck or mouth, as indicated as 702 in D. This in turn,
brings the expanded expandable body 100 or 140 into contact with the aneurysm wall
704 in, near, or nt to the neck or mouth 703 of the aneurysm. The coil or
accessory coil 162 is then fed through the catheter 300 or 400, through the interior of
the expandable body 100 or 140 and delivered into the aneurysm lumen 701, as shown
in E, including passing the coil or accessory coil through the guide wire lumen.
The accessory coil 162 is inserted until the ory coil contacts both the aneurysm
wall 704 opposite the mouth 703 and the external e of the expandable body 100
or 140, where the accessory coil exerts a uous force on the expandable body
causing the expandable body to seal the mouth of the aneurysm 700. As shown in F, after the expandable body 100 or 140 is expanded and the coil or accessory coil
has been placed, the delivery catheter 300 or 400 and the expandable body 100 or 140
are ed or separated and the delivery catheter is removed while leaving the
expanded body in the lumen 701 of the aneurysm where it seals the mouth 703 of the
aneurysm, and the accessory coil in place in the lumen of the aneurysm behind the
expanded body where it acts to hold the ed ballstent in place.
A variety of s and devices can be used to separate the ry
catheter 400 from the ballstent, tent, or expandable body. In one embodiment as
ted in FIGS. 9, 10A-B, and 23A, the delivery catheter 300 or 400 comprises one or
more electrolysis wire(s) 320 or insulated conductor wire(s). For this embodiment, after
the ballstent 100 is expanded, an electrical current is applied to the olysis wire(s)
320 or the insulated conductor wire(s) to dissolve a portion of the proximal neck of the
ballstent 100 by electrolysis (including a stainless steel portion). In alternative
embodiments, the electrical current may be applied to dissolve a portion of a stainless
steel ring 250 between the ballstent 100 and the delivery catheter 300 or 400 or to
dissolve a portion of the proximal region of the ballstent 100 by electrolysis. A direct
current (DC) may be used for any of these ments. . Once a portion of the
proximal neck, stainless steel ring 250, or proximal region of the ballstent 100 is
dissolved or corroded, the delivery catheter 300 or 400 is separated from the expanded
ballstent and the delivery catheter and the guide catheter 800 are removed.
In various embodiment, a double lumen catheter has a coil-reinforced
wall consisting of one, two, or three electrical conductor (e.g., wires or cables) to
provide conductive path(s) for performing electrolysis, as explained more fully below. In
one embodiment, the external e of the wall is composed of polyimide and has a
hilic or ious coating, while the conductive ) includes 0.001 inch X
0.003 inch flat stainless steel or copper coils. The conductor coils 1006 can be
configured in a one, two, or three conductor arrangement, as discussed below with
regard to performing electrolysis. The conductors of the coil and any other conductors
may be straight, braided, or coiled. The conductive path defined by the conductor coils
can be coated in an insulating polymer such as Parylene, while the interior lumen can
be lined with PTFE, including a PTFE composite.
In some embodiments all or a portion of the or and exterior
surfaces of the ry device or catheter can be r coated with a hydrophilic or
lubricious coating. In other embodiments, all or a portion of the expandable body 100,
140, 150, or 170A-G can also be coated with a hydrophilic or ious coating.
Guidance Members
As shown in FIGS. 15A-F, for an embodiment using a double lumen
catheter, the delivery catheter 300 moves over a guidance member or guide wire 302 to
deliver the compressed ballstent 140 to the lumen 701 of a saccular aneurysm 700.
Examples of a guidance member include a flexible guide wire. The guide wire 302 can
comprise metal in the form of a flexible thread, coil, or slender rod. For example, the
basic angiography guide wire consists of a fixed solid metal core covered by a metal
spring coil. In other situations, a delivery catheter is advanced over a needle or r.
The guide wire 302 occupies a lumen in the delivery catheter, with such lumen defined
by the tubular n of the delivery catheter. Once located in place, the guide wire 302
can be removed in order to allow the ion or withdrawal of a fluid medium.
As shown in FIGS. 21A-B, in another embodiment, the delivery
catheter of the medical device can be configured with a lumen that can accept a guide
catheter 800 as a guidance member. With this configuration, the medical device can be
advanced in a tri-axial configuration, with the medical device 500 advanced over a guide
catheter 800, which is advanced over a guide wire. In n embodiments, the
proximal hub on the guide catheter can be d to allow the lumen of the hollow
cylindrical member 304 of delivery catheter 300 of the medical device 500 to accept the
guide catheter 800. In n instances, this embodiment of the medical device can
result in better control over the delivery of the compressed expandable body to the
aneurysm or target blood vessel lumen and better trackability of the compressed
expandable body 100, 140, 150, or 170A-G as it is advanced to the desired location. As
shown, in one aspect, the hollow rical member 304 of delivery catheter 300 may
be annular shaped and fully encircle the guidance catheter 800, while in other aspects,
the delivery catheter may engage 60%, 70%, 80%, 90%, or more of the circumference
of the guidance catheter.
Exemplam Ballstent Catheter and Expandable Body Catheter Medical Devices
A depicts an embodiment of an expandable body medical
device that can be used as a ballstent catheter 3400A. As shown, the ent catheter
medical device 3400A es a delivery catheter 3402 configured at a distal end 3404
for engaging the ballstent 100. The proximal end 3406 of the delivery catheter 3402 is
engaged to a hub 3408 that permits electrical and fluid communication with the ballstent
100 h the catheter. A syringe 314 may be used to deliver a fluid medium to the
ballstent 100. The device 3400A also includes an electrical connector or port 3422 for
establishing electrical communication from a handheld controller 3418 to the ballstent
100, including h electrolysis wires or conductors present in the wall of the delivery
catheter.
B depicts an embodiment of an expandable body medical
device that can be used as a blockstent l device 3400B. As shown, the medical
device 34OOB includes a delivery catheter 3402 configured at the distal end 3404 for
ng the expandable body 100. The proximal end 3406 of the delivery catheter
3402 is engaged to a hub that permits electrical and fluid communication with the
expandable body 150 through the er. A syringe 314 may be used to deliver a
fluid medium to the expandable body 150. The device 34OOB also includes an electrical
connector or port 3422 for establishing electrical communication from a power source
(not shown) to the expandable body 150, including through electrolysis wires or
conductors present in the wall of the delivery catheter.
A sectional view of a hub 3408 for a medical device with a single
lumen delivery catheter wherein the primary method of detachment is electrolysis is
shown in A. The hub 3408 es a first connection port 3410 that is
configured with a Luer hub or taper that may facilitate a Luer-Lok or Luer-Slip type
connection for connecting a fluid medium source, such as a syringe 314, to the lumen
312 of a hollow cylindrical member of the delivery catheter 3402 configured to transmit
the fluid medium from the proximal end of the delivery catheter to the central void or
space 108 of the able body 100, 140, 150, or 170A-G. Optionally, the first
tion port 3410 may also accept a guide wire or guidance member. The hub 3408
is also configured with a second connection port 3422 is configured to allow for
electrical communication with the catheter 3402. For e, one or more electrolysis
wire(s) 320 in electrical communication with electrodes mounted on the catheter 3402
and/or the ent, blockstent, or able member 100 may extend through a
channel 3416 of the hub 3408 and into the second connection port 3422. Alternatively,
one or more resistive wires may extend through the channel 3416 of the hub 3408 and
into the second connection port 3422. A power source or source of electricity, such as
a handheld controller 3418 shown in FIGS. 31A and 33, may communicate with the wire
320 to perform various functions including, but not limited to, electrolysis or heating a
heat-sensitive material, such communication occurring through a coupling of the
electrical connector portion 3424 of the handheld controller and the connection port
3422 of the hub 3408.
A view of a hub 3408 for a medical device with a double lumen delivery
catheter wherein the primary method of detachment is electrolysis is shown in B.
The hub 3408 es a first connection port 3410 that is ured with a Luer hub or
taper that may facilitate a Luer-Lok or lip type connection for connecting a fluid
medium source, such as a syringe 314, to the lumen 312 of a hollow cylindrical member
of the delivery catheter 3402 configured to transmit the fluid medium from the proximal
end of the delivery catheter to the central void or space 108 of the expandable body
2014/030869
100, 140, 150, or 170A-G. The hub 3408 is also configured with a second connection
port 3422 is configured to allow for electrical communication with the catheter 3402. For
example, one or more electrolysis wire(s) 320 in electrical communication with
electrodes mounted on the catheter 3402 and/or the ballstent, blockstent, or expandable
member 100 may extend through a channel 3416 of the hub 3408 and into the second
connection port 3422. Alternatively, one or more resistive wires may extend through the
channel 3416 of the hub 3408 and into the second connection port 3422. A power
source or source of electricity, such as a ld controller 3418 shown in FIGS. 31A
and 33, may communicate with the wire 320 to perform various functions including, but
not limited to, electrolysis or heating a ensitive al, such communication
occurring through a coupling of the ical tor portion 3424 of the handheld
ller 3418 and the connection port 3422 portion of the hub 3408. A third
connection port 3410 is also configured to receive and engage a guide wire 302 or an
obturator wire 404.
A view of a hub 3408 for a medical device with a double lumen delivery
catheter wherein the primary method of detachment is mechanical is shown in C. The hub 3408 includes a first connection port 3410 that is configured with a Luer
hub or taper that may facilitate a Luer-Lok or Luer-Slip type tion for connecting a
fluid medium source, such as a syringe 314, to the lumen 312 of a hollow cylindrical
member of the delivery catheter 3402 configured to transmit the fluid medium from the
proximal end of the delivery catheter to the central void or space 108 of the expandable
body 100, 140, 150, or 170A-G. A second connection port 3410 is also ured to
receive and engage a guide wire 302 or an obturator wire 404.
As shown in FIG32A, in a preferred embodiment, the second
connection port 3414 is bonded to a threaded nut 3420, such that an electrical terminal
3422 may be secured to the nut and the hub 3408. The electrical terminal 3422 is in
electrical communication with the one or more conductive wires and configured to
receive an electrical connector from an external power source, such as the handheld
controller 3418. By way of example and not limitation, the electrical connector 3424
may be a 3.5 mm audio jack. Other electrical connectors may also be used.
As shown in , the handheld controller 3418 can be connected
to the electrical terminal 3422 through a jack 3424 to deliver an ical t
through the catheter 3402 for detaching the expandable body 100, 140, 150, or 170A-G.
For example, in one embodiment, the catheter 3402 includes a conductive coil 1006
that may be arranged in a one, two, or three conductor arrangement 1007, 1008, and
1010, respectively, as shown in FIGS. 23C and 23E and 23F. The various conductor
arrangements 1008 and 1010 can e both reinforcing strength and a conductive
pathway along the length of the er 3402. The handheld controller 3418 provides
a current or a voltage ial to the electrodes 1014, 1016, and optionally 1026,
extending through the catheter 3402 to detach the expandable body 100, 140, 150, or
170A-G by electrolysis or thermal detachment, as explained below. In one
embodiment, the handheld controller 3418 includes a body 3426, a power supply such
as a battery, one or more actuation buttons 3428, and one or more indicators 3430 to
indicate the status of the controller, the detachment of the expandable body 100, 140,
150, or 170A-G, and the status of the power source, such as the battery.
Folding the Expandable Body
In order to facilitate advancement of the able body through the
vascular system, the expandable body 100, 140, 150, or 170A-G can be compressed
into various shapes and dimensions. Optionally, this compression can include various
forms and patterns of folding or pleating. For example, one or more pleats can be made
in the expandable body 100, 140, 150, or 170A-G and then the pleats can be wrapped
into a cylindrical shape. Alternatively, the expandable body 100, 140, 150, or 170A-G
may be flattened into a planar shape and then rolled into a cylindrical shape.
Alternatively, the expandable body 100, 140, 150, or 170A-G may be compressed into a
compact spherical shape. Additionally, the portions of the expandable body 100, 140,
150, or 170A-G may be twisted during compression. In certain embodiments, the
able body may be compressed around the ry catheter 300, as in A.
In other ces, the expandable body may be compressed around the tor 404,
as in A. In other embodiments, the expandable body may be compressed
around a guidewire, including embodiments wherein the l device has a delivery
catheter with single lumen, where the single lumen is used both to deliver fluid to the
central void of the expandable body for inflation or expansion and to accept a guide wire
or guidance member. In other embodiments, the expandable body 100, 140, 150, or
170A-G may be compressed on , without a central catheter, obturator, or
guidewire.
In A, the expandable body 100, 140, 150, or 170A-G has been
pleated, folded, and wrapped around a hollow cylindrical member 304 of the delivery
catheter 300, such hollow cylindrical member including a bridging catheter, similar to the
bridging catheter 160. Such ment may also comprise ssion of the folded
and d expandable against the delivery catheter. In 8, the expandable
body 100, 140, 150, or 170A-G is pleated and d without being wrapped around a
hollow cylindrical member or delivery catheter. In another embodiment, the expandable
body 100, 140, 150, or 170A-G is folded into pleats, then the pleats of the folded
expandable body are d around an obturator, removable wire, guidewire, or
guidance member 304, as shown in 0. Such ment may also comprise
compression of the folded and wrapped expandable against the obturator, removable
wire, guidewire, or guidance member 304. In another embodiment, the expandable
body 100, 140, 150, or 170A-G is folded into pleats, and then the pleated folds are
rolled into a generally cylindrical shape without a removable wire, obturator, ire,
guidance member or er acting as central fixation point, as shown in D.
In various embodiments, the expandable body 100, 140, 150, or 170A-
G is attached to the delivery catheter 300, 400, then the pleats are formed, and then the
d folds are wrapped and compressed onto the delivery catheter 300, obturator
404, or guidewire. In another embodiment, the expandable body 100, 140, 150, or
170A-G is first folded to form pleats, and then attached to the delivery catheter 300,
400, and then the pleated folds are wrapped and compressed onto the outer surface of
the delivery catheter 300, obturator 404, or guidewire. In r embodiment, the
expandable body 100, 140, 150, or 170A-G may be folded and compressed into a
variety of shapes in a manner r to Japanese origami.
WO 46001
The expandable body 100, 140, 150, or 170A-G may be folded to form
one or more pleats, which may be further folded, rolled, and ssed, similar to the
folding of non-compliant angioplasty expandable bodies. In various other embodiments,
the pleated expandable body is folded and compressed to fit on the end of a le
guide wire and travel within a hollow cylindrical member of a separate catheter. The
expandable body 100, 140, 150, or 170A-G may be folded and compressed using any
suitable arrangements and methods. It is desired that the surface of the expandable
body 100, 140, 150, or 170A-G be smooth when in the ry configuration. In n
embodiments, it is desired that the folding of the expandable body 100, 140, 150, or
170A-G result in even folds.
Detaching the Expandable Body
The expandable body 100, 140, 150, or 170A-G may be attached to, or
engaged with, the delivery catheter in a variety of ways. For example, the expandable
body 100, 140, 150, or 170A-G may be affixed to the delivery catheter by a friction fit,
using an adhesive, or glue, by a weld or solder, by a junction or uniting of components,
or by the application of a compressive force from a clamp, ring, elastomer sleeve or
wrap, or compressive balloon. Various methods and devices may be used to separate
the expanded expandable body from the ry catheter. By way of example and not
limitation, these methods and devices may be broadly categorized as al or
mechanical, electrical, thermal, chemical, hydraulic, and sonic.
Detachment by Electrolysis
The expandable body 100, 140, 150, or 170A-G may be detached or
separated from the delivery catheter by electrolysis. When using electrolysis, a
constant current, nt voltage, or square wave voltage potential may be used.
Detachment of the expandable body 100, 140, 150, or 170A-G from the delivery
catheter may be med using a medical device or system with one, two, or three
electrical conductors, as shown in FIGS. ZBB-F. In one embodiment, a conductor
arrangement 1010 includes three conductors incorporated into, or carried by, a delivery
er 1000. In alternate ments of a three-conductor arrangement two
2014/030869
conductors are incorporated into, or carried by, a delivery catheter 1000 and a third
conductor is configured to make electrical contact with patient in another manner, such
as with an electrode patch or ode needle. Similarly, one conductor may be is
incorporated into, or carried by, a delivery catheter 1000 and two tors that are
configured to make electrical contact with patient in another manner, such as with an
electrode patch or electrode , such as the patch 3106 shown in A. In a
two conductor arrangement 1008, two tors are incorporated into, or carried by, a
delivery catheter 1000. Alternatively, one conductor may be orated into, or
carried by, a delivery catheter 1000 and one conductor is configured to make electrical
contact with patient in another manner, such as with an electrode patch 3106 or
ode needle, as shown in A. Another conductor arrangement 1007, as
shown in F, includes a single conductor arrangement, where a single conductor
is incorporated into, or d by, a delivery catheter 1000.
The medical device or system may further comprise a terminus such as
an electrode at the distal end of the conductor, including a terminus that is a tubular or
ring shaped cathode ring 1028. In other embodiments, the terminus is a ring-shaped
segment of exposed stainless steel in the proximal neck of the expandable body, such
segment capable of functioning as an anode.
WO 46001
The two-conductor arrangement may be used to m constant
current electrolysis, wherein one conductor is ically coupled to an anode and one
conductor is electrically coupled to a cathode, as shown in G. The various
three-conductor arrangements may be used to perform nt voltage electrolysis or
electrolysis using a square-wave voltage potential, wherein one conductor is electrically
coupled to an anode, one conductor is electrically coupled to a cathode, and a third
conductor is electrically coupled to a reference electrode. In any of these
arrangements, the electrical conductors or electrodes may be composed of any
biocompatible conductive material including platinum, stainless steel, gold, or silver, and
alloys thereof. In one example, the electrical conductors or odes may be
comprised of a platinum-iridium alloy.
When using the two electrical conductor arrangement 1008 to perform
constant current electrolysis, there is less control over the voltage potential in the anode
or working electrode 1014. As such, the voltage potential at the working electrode 1014
and anode site or portion 3102, increases until the potential and current g to the
working electrode, or anode, is sufficient to cause oxidation of ions in the bloodstream
near the working electrode, or anode. For e, the electrical current may break
down H20 molecules in the bloodstream to form H+ ions and electronegative 02
molecules. In one example, the 02 molecules can then bond to exposed gold at the
g electrode, or anode, of a gold expandable body 100, 140, 150, or 170A-G and
dissolve the exposed gold strip, thereby enabling detachment of the expandable body
and the delivery catheter. In one embodiment, a polymer coating on the expandable
body 100, 140, 150, or 170A-G can be an electrical insulator or tric material that
prevents or retards the H+ ions and 02 molecules from ng with the coated portions
of the expandable body. In another example, electrolysis can occur in a ring-shaped
strip of exposed stainless steel at the anode site 3102, in the neck of expandable body
wherein the main body ses gold, resulting in ution of the exposed stainless
steel, thereby enabling detachment of the expandable body and the delivery er.
In one ment, a polymer coating on the expandable body 100, 140, 150, or 170A-
G can be an ical tor or dielectric material that prevents or retards electrolysis
the coated portions of the expandable body.
In one embodiment, approximately 0.01 to 5.0 mA of constant current
is provided between the anode site 3102 or the working electrode and a cathode or
ground electrode 3106 electrically engaged to an electrode patch 3106 on the t’s
skin or a needle in the patient that functions as the cathode for the electrolysis system
and process. In another embodiment, the cathode or ground ode is mounted on
the delivery catheter 300, as shown by 1028 on G, including in the form of a
conductive cathode rings or tube. Another embodiment of the two electrical conductor
arrangement is shown in FIGS. 23H-l. In this embodiment, the proximal end 1018 ofa
thermoset polymer t 1020 is bonded to a distal end 1022 of the catheter 1000,
while the distal end 1024 of the set polymer segment is bonded to metallic ring
3208 formed in the neck 116 or 3208 of the expandable body 100, 140, 150, or 170A-G.
An anode site 3102 is present in the neck 116 of the expandable body 100, 140, 150, or
170A-G. As shown in H, a conductor wire 1014 is ed within the polymer
segment 1020 and bonded to the neck 116 or 3208 of the expandable body 100, 140,
150, or 170A-G, resulting in an electrical connection to the ring-shaped anode site 3102,
via the working electrode 1014. In one embodiment, the conductor wire may be bonded
directly to the anode site 3102. In some embodiments, the conductor wire 1014 may be
bonded to the neck 116 or 3208 of the expandable body 100, 140, 150, or 170A-G
using a silver adhesive or any other suitable adhesive. In other embodiments, the
conductor wire 1014 may be welded to the neck 116 or 3208 of the expandable body
100, 140, 150, or 170A-G, ing by laser welding.
As shown in H, a cathode, or ground electrode 1028 is
mounted on the delivery catheter 1000. onally, a conductor wire 1016 is
embedded within the wall of the ry catheter and bonded to the cathode, or ground
electrode 1028, resulting in an electrical connection to the cathode, or ground electrode
1028, which is ring-shaped. In one embodiment, the conductor wire may be bonded
directly to the cathode ring 1028. In some embodiments, the conductor wire 1016 may
be bonded to the cathode ring 1028 using a silver adhesive or any other suitable
2014/030869
adhesive. In other embodiments, the conductor wire 1016 may be welded to the
cathode ring 1028, including by laser welding.
In another embodiment, the three electrical tor arrangements
may be used to provide more control and selectivity in the voltage potential of the anode
site 3102. In on to the working electrode 1014 and the ground electrode 1016, the
three electrical conductor arrangement includes a reference electrode and a
potentiostat (not shown) that are used to monitor and l the voltage potential of the
and, or working electrode, relative to the nce electrode. In various embodiments,
the reference electrode is preferably made of platinum, silver, or silver chloride. By way
of example and not limitation, the three electrical conductor arrangement can be used to
detach the expandable body 100, 140, 150, or 170A-G using a nt current, a
constant voltage or an alternating square wave-potential voltage. The working
electrode 1014 is modulated based on a comparison n the voltage of the anode
site 3102 via the working electrode1014 and the voltage of the reference electrode,
which in some embodiment can be supported on the delivery catheter and in other
embodiments can be ured to make ical contact with patient in another
manner, such as with an electrode patch or electrode . In one embodiment, the
potentiostat is configured to e a voltage in the range between approximately +0.5
V and +1.5 V at the working electrode 1014 relative to the reference electrode.
In various embodiments, the electrical current travels from the cathode
ring 1028 that is supported on the delivery catheter 1000 to a location outside the body
of the patient by a tive wire 1016 embedded in the wall of the delivery catheter.
The conductive wire 1016 can also simultaneously provide structural reinforcement for
the wall of the delivery catheter 1000.
In another embodiment, the expandable body 100, 140, 150, or 170A-
G and the delivery catheter 300 may be joined by one or more non-insulated welds 316,
solder, or an adhesive 318, as shown in A, including embodiments wherein the
joining is between the al neck 116 and the distal end of the delivery catheter 304
or 306. An electrical conductor 320, which may be in the form of a wire, or cable that
relies on the surrounding electrical insulating material of the catheter wall and/or a
dedicated electrical insulating jacket of the electrical conductor itself for electrical
insulation, s along the length of the ry catheter from the proximal end of the
delivery catheter 300 to the distal end of the delivery catheter. The proximal end of the
electrical conductor 320 is electrically coupled to a power source or source of electrical
current 3100 outside the patient’s body. The power source 3100 is also in electrical
communication with a needle or electrode patch 3106 on the patient’s skin that
functions as the cathode for the electrolysis process. The distal end of the electrical
conductor 320 is coupled to the al portion of the expandable body 100, 140, 150,
or 170A-G, which is also coupled to the distal portion of the delivery catheter. In this
embodiment, a portion of the neck expandable body 100, 140, 150, or 170A-G is
functioning as the anode site 3102 for electrolysis. In this embodiment, the electrolysis
electrical conductor 320 is in electrical communication with the portion 3102 of the
able body that is not electrically insulated and that is not bonded to the delivery
catheter (i.e., the anode site). In s embodiments, the electrolysis electrical
conductor 320 can lie within the wall of the delivery catheter 300 as shown in A,
along the exterior surface of the delivery catheter, or within a lumen of the delivery
catheter.
In some embodiments, as shown in A, the electrical conductor
320 is insulated, wherein a proximal anode n 3102 of the expandable body 100,
140, 150, or 170A-G is not ted, including a n of the proximal neck, which is
similar to detachment site 3302, as shown in 30A-F. In some embodiments, the
electrical conductor 320 and the remainder of the expandable body 100, 140, 150, or
170A-G and 116, including the remainder of the necks, are insulated; while a proximal
anode portion 3102 of the expandable body is not insulated, including a portion of the
proximal neck in some embodiments. In some embodiments, the neck 116 of the
able body 100, 140, 150, or 170A-G is comprised of metal that can readily
undergo electrolysis (such as stainless steel) wherein the remainder of the expandable
body is comprised of a metal that does not as readily undergo electrolysis, such as gold
or um. For this embodiment, the gold or um portion of the expandable body
100, 140, 150, or 170A-G may not need to be insulated. An electrical current or charge
is applied to the ical conductor 320 after the expandable body 100, 140, 150, or
170A-G is expanded. The current is applied in an amount and for a time sufficient to
dissolve at least a portion of the non-insulated anode portion 3102 of the expandable
body 100, 140, 150, or 170A-G, enabling the separation of the delivery catheter from
the expandable body, n the expanded expandable body remains in place at the
desired position while the delivery catheter 300 is removed.
In another embodiment, an electrical current is d to the electrical
conductor 320 after the expandable body 100, 140, 150, or 170A-G is expanded. The
current is applied in an amount and for a time sufficient to dissolve at least a portion of a
weld or solder between the expandable body 100, 140, 150, or 170A-G and the delivery
catheter 300, enabling the tion of the delivery er from the expandable
body, wherein the expanded expandable body remains in place at the desired position
while the ry catheter 300 is removed. In another embodiment, the current is
applied in an amount and for a time sufficient to dissolve at least a portion of the main
body of the expandable body ng the separation of the delivery catheter from the
expandable body, n the expanded expandable body remains in place at the
desired position while the delivery catheter 300 is removed. In one embodiment the
current is a direct current (DC) while in another embodiment, the current is an
alternating current (AC).
Typically, during constant current electrolysis, gas bubbles formed as a
byproduct of the electrolysis tend to form an insulating barrier at the detachment site.
The gas bubble barrier in combination with an aggregation of non-ionic blood
constitutes (fats, proteins, and amino acids, among others) at the detachment site tends
to increase impedance at the detachment site and increase the time necessary for
detachment, as the rate of electrolysis is decreased. Similarly, blood may begin to clot
at the detachment site 3302 r impeding the ment processes.
Electrolysis is preferably performed when the expandable body 100,
140, 150, or 170A-G is oned such that the ment site 3302 shown in FIGS.
30A-F is within a constant stream of ionic blood constituents. For example, when the
ent 100 is positioned to fill an aneurysm, the detachment site 3302 can be
positioned such that the detachment site protrudes into the adjacent parent blood vessel
or near the adjacent parent blood vessel. While in or near the adjacent parent blood
vessel, the detachment site 3302 is exposed to a constant stream of ionic blood
constituents that aid in the olysis process to detach the ballstent 100. The
constant stream of blood also minimizes the incidence of blood coagulation at the
ment site 3302 during electrolysis, y potentially ng the time required
to separate the expanded expandable body 100, 140, 150, or 170A-G and the delivery
catheter, and reducing the risk of embolism of thrombus and stroke, when cerebral
aneurysms are treated.
In another ment, voltage controlled electrolysis is med
using an alternating square wave potential voltage. By way of example and not
limitation, the potential at the anode site 3102 or working electrode 1014, as shown in
FIGS. 23H-l, alternates between approximately +0.5 V and approximately +0.8 V,
relative to the reference electrode, at a frequency in a range between 0.1 Hz and 10 Hz.
In one aspect, the rate at which the voltage potential of the anode site 3102 or working
electrode 1014 varies may be configured to allow for removal of oxides that form on the
surface of the anode or working electrode and any aggregation of n that may form.
In this embodiment, oxides are removed during the sivation” period of lower
voltage while aggregated proteins are removed during the “passivation or hydrolysis”
period of higher voltage. The removal of both oxides and aggregated proteins is
promoted by the voltage g. Therefore, the use of an alternating square wave
potential voltage or the use of square wave voltage pulses may allow for a shorter and
more consistent detachment times.
In s embodiments, the voltage ranges used to perform voltage-
controlled electrolysis may vary in response to the composition of the material at the
detachment site 3302 (e.g., anode portion 3102) and the reference electrode. For
example, if the detachment site 3302 is composed of gold and the reference electrode
1026 is composed of um then the voltage at the gold anode may alternate
between approximately +0.6 V and approximately +1.4 V relative to the reference
electrode at approximately 1 Hz. sely, the e potential at a detachment site
3302 composed of 304 stainless steel may alternate between approximately +0.1 V and
approximately +0.4 V relative to the platinum reference electrode at approximately 1 Hz.
In one embodiment, the detachment site 3302, functioning as an anode site 3102, is
316L ess steel. In this embodiment, electrolysis is performed such that the
potential at the 316L stainless steel anode ates between approximately +0.7 V
and approximately +1.2 V relative to the platinum reference ode at approximately
1 Hz. In various embodiments, it is desirable for the lower e of the alternating
square wave voltage potential to be below the hydrolysis potential of water.
g the Detached Expandable Body
In one embodiment, the opening 112 and or 114 of the expanded
expandable body 100, 140, 150, or 170A-G is left open at the end of the procedure,
including the opening in a proximal neck or a distal neck. In other embodiments, the
openings 112 and/or 114 of the expanded able body 100, 140, 150, or 170A-G is
closed prior to the end of the procedure. By way of example and not tion, the
opening 112 may be sealed by applying an external force with the inflation of the
balloon portion 1102 of a balloon catheter 1100 adjacent to the expanded expandable
body 100, 140, 150, or 170A-G, as shown in E. Alternatively, an opening may
be sealed by ng a loop of le material around the external surface of the neck
of the expandable body 100, 140, 150, or 170A-G prior to separation of the expanded
expandable body and the delivery catheter. In this method, the loop of material may
comprise a wire, polymer strand, filament, string, , or snare.
In various embodiments, one or both necks 116 and 118 of the
expandable body 100, 140, 150, or 170A-G are plugged or othenNise sealed after
inflation. For example, the necks 116 and 118 may be plugged by the ion of a
solid structure dimensioned to fit securely within the necks. This material may be a
sponge, a coil, or a metallic cap that is placed over or within the necks 116 and 118.
Radiopague Marking of the Expandable Body
According to any of the methods where the expandable body 100, 140,
150, or 170A-G is detached or separated from delivery catheter, one or more
aque markers may be incorporated into the appropriate portions of the
expandable body or delivery catheter, in addition to the nose cones 360 or 362A-B, to
assist in the positioning of the expandable body, expansion of the expandable body,
detachment or separation of the expanded expandable body from the delivery catheter,
and removal of the delivery catheter after detachment or separation. For example, a
radiopaque marker band or spot may be incorporated into the medical device to identify
the location where separation is intended or designed to occur. In addition, radiopaque
material may be incorporated into the expandable bodies 100, 140, 150, or 170 A-G. In
addition, a aque spot or marker band may be incorporated into distal end of the
delivery catheter so that the tip of the ry catheter can be visualized under
fluoroscopy while pulling the delivery catheter away from the expanded expandable
body 100, 140, 150, or 170A-G. A radiopaque spot or marker band may also be placed
onto the ment components, as need be. The radiopaque marker may comprise
various radiodense materials, including but not d to a metal band, a metal spot or
line, or spot or a line of barium.
In various embodiments, a saccular aneurysm 700 or a blood vessel
may be visualized by using a radiopaque dye. The radiopaque dye may be injected
prior to introducing the expandable body 100, 140, 150, or 170A-G and can be used to
confirm the appropriate size and position for the compressed or expanded body.
able Body Medical Kit
In s embodiments, a medical kit may be provided for treating a
patient with the l device. The medical kit may include the l device 500, a
guide wire 302, one or more guide catheters 800, one or more expandable body support
structures, one or more accessory coils, and instructions for methods for separating the
expanded expandable body 100, 140, 150, or 170A-G from the delivery er 300 or
400. In various ments, the medical kit may including medical devices comprising
accessory coils or delivery catheters for accessory coils, and te medical devices
for separation, such as a power source and controller for performing electrolysis or
heating a thermally-sensitive g structure that joins the expandable member 100,
140, 150, or 170A-G and the delivery device. The medical kit may further include
instructions for use. The instructions for use may be provided on the ing of the
medical kit in the form of a label. The instructions for use may be provided in any
tangible medium (e.g., paper, CD, or DVD) either separate from the medical kit or
contained within the ing of the medical kit. The instructions for use may be
provided via an electronic data feed or via instructions posted on the Internet.
The medical device 3400A can be used as part of various s,
methods, and medical kits. These systems, methods, and medical kits can be used to
treat saccular arterial aneurysms, such as a saccular cerebral aneurysm. Alternatively,
these systems, methods, and l kits can be used to treat a variety of medical
ions. In one embodiment, the systems, methods, and medical kits can be used to
occlude biological conduits in patients in need f, the biological conduits including
arteries, veins, vascular structures, ducts, airways, bile ducts, pancreatic ducts,
enterocutaneous fistulas, ureters, fallopian tubes, and urethras, among others. The
medical kit includes the medical device and instructions for use. The l kit may
also contain additional components for carrying out a variety of treatments using the
medical device 500.
e Methods for Manufacturing a Medical Kit
FIGS. 34-36 are flowcharts of methods to manufacture the expandable
body 100, 140, 150, or 170A-G, a delivery catheter 1000, and a medical kit. In one
embodiment, a method 4000 for making the expandable body 100, 140, 150, or 170A-G
es forming the expandable body on a mandrel at step 4002 and coating the
expandable body at step 4004. At step 4006, the detachment site and the sites where
the conductive wires are bonded to the expandable body 100, 140, 150, or 170A-G are
exposed. The expandable body 100, 140, 150, or 170A-G is then annealed, folded,
wrapped, and annealed again at steps 4008-4012.
A method 4100 to manufacture or otherwise prepare an ng
delivery catheter is provided. At step 4102, a coil-reinforced er 3402, with
electrically conductive coils is obtained and the outer coating is removed from the
catheter to expose a portion of the electrical conductors of the coil at step 4104. At step
4106 a portion of the exposed ical conductors are unwrapped, a cathode ring 1028
is bonded to the catheter 1000 and an electrical conductor thereof at step 4108, and the
exposed electrical conductors are then covered with an insulating material at step 4110.
The bonding sites on the catheter 3402 are masked, and the catheter is coated with a
hydrophilic or lubricious coating at steps 4112 and 4114. One end of the catheter 3402
is ured for engagement to a fluid source and optionally a source of electrical
current. By way example and not limitation, the catheter 1000 may be bonded to a hub
that may r include a Luer fitting, an electrical jack, or a port for passage of a guide
wire.
The electrical conductors 1014 and 1016 are bonded to the anode and
cathode, respectively, and then the electrical conductors are extended from the delivery
catheter and covered in ting jackets at steps 4118 and 4120. At steps 4122 and
4124, the extension ical conductors are soldered to electrical plugs, such as the
electric al 3422, and the soldered joints are insulated.
As shown in , the method 4200 to assemble the medical
device 3400A and a medical kit includes g the expandable body 100, 140, 150,
or 170A-G to the er 3402 at step 4202. At step 4204, the electrical conductor
1014 is bonded to the expandable body 100, 140, 150, or 170A-G to form an anode and
the exposed conductive surfaces are further insulated at step 4206. Once assembled,
the device 3400A is tested at step 4208 and packaged in a medical kit at step 4210.
Example Methods of Using the Expandable Body
A typical method for using the medical device 3400A to treat a saccular
aneurysm includes accessing the vascular system of a human with a needle, passing a
guidance member, or guide wire, 302 into the vessel, optionally placing a vascular
sheath, advancing the medical device comprising a ssed ent 100 and a
delivery er 300 or 400 and advancing it until the compressed ballstent is located
in the lumen 701 of an aneurysm sac 700, such ballstent configured to occupy only a
portion of the lumen or cavity of the saccular aneurysm. Then the ballstent 100 is
WO 46001
expanded by passing a fluid, liquid, gas, or solid material, or combinations thereof,
through the delivery catheter and into the central void or space 108 of the ballstent. The
guidewire is removed and a coil delivery catheter with a aded accessory coil is
passed through the guide wire until its tip has exited the distal end of the l
device, including exiting from an expandable body, the neck of an able body or a
nose cone affixed to an expandable body. The ory coil is then expelled from the
coil delivery catheter and into the unfilled portion of the lumen of the aneurysm such that
the accessory coil makes t with the wall of the aneurysm opposite the opening
from the parent vessel into the aneurysm lumen and simultaneously makes contact with
the exterior surface of the wall of the expanded expandable body. Optionally, one or
more additional accessory coils can be placed, as needed. The ry catheter is
then separated from the expanded ent 100 are then the delivery er is
removed from the body, while the expanded ballstent and the accessory coil(s) remain
in place within the lumen 701 of the aneurysm sac 700. The position of the ballstent
100 and accessory coil(s) during and after the procedure may be monitored by any
suitable methods, including fluoroscopy, computed tomography, MRI, and ultrasound,
including intravascular ultrasound. The degree of occlusion of the aneurysm can be
evaluated using angiography before and after detachment of the expanded ent
100 from the delivery catheter.
In s embodiments of the ballstent 100, the shape of a ballstent
that has been expanded in the lumen ofa saccular aneurysm is determined, in part, by
the formed shape of the ballstent. For example, in some embodiments, the ballstent
100 is manufactured into a round, oblong, irregular, or non-spherical orientation to
match at least a portion of the rs of the cavity for a ular saccular aneurysm
700, including the diameter of the opening into the saccular aneurysm from the adjacent
parent vessel from which it arose. The ed shape is also determined by the size
and shape of the lumen of the saccular aneurysm. The expanded shape can also be
determined by the application of an external force, such as by inflating the balloon
portion of a balloon catheter adjacent to the expanded ballstent 100. In certain
embodiments of the methods, the balloon portion 1102 of a balloon catheter 1100 is
inflated in the lumen of the parent blood vessel 1202 adjacent to the expanded ballstent
100 in the lumen of the aneurysm sac, thereby pushing the wall 1104 of the ballstent
100 toward the aneurysm, as shown in E. In other embodiments, the ballstent
100 is manufactured into a non-spherical orientation to match the contours of the cavity
for a ular saccular aneurysm 700.
In all embodiments, the expanded shape of the ballstent 100 is
determined by the following factors: 1) the manufactured shape of the ent 100; 2)
the degree of ballstent expansion; 3) the size and shape of the aneurysm 700; and 4)
the effect of any applied external force on the ballstent after expansion. By way of
example and not tion, the manufactured size and shape of the ballstent 100 may
be determined by making measurements of the aneurysm 700. The measurements can
be made by using medical , including two-dimensional and dimensional
reconstructions, and standard distance reference markers. Other methods of
measuring the aneurysm may also be used.
In another embodiment, the position, size, and shape of the expanded
ent 100 can be manipulated while positioned within the aneurysm 700. In this
embodiment, it is not necessary to determine the precise contours of the aneurysm 700
prior to inserting the ballstent 100. The ballstent 100 is shaped by the degree of
expansion of the ballstent and the application of external forces. For example, an
external force may be applied by inflating the n portion of a balloon catheter
adjacent to the ed ballstent 100, or by tools inserted through or around the
ry catheter 400 or guide catheter 800. In other embodiments, the ballstent 100
may be shaped in a step prior to or after the step of separating the ed ballstent
from the delivery catheter 400.
In s embodiments, the ballstent 100 is designed so that the
exterior surface 110 or 124 of the expanded ballstent 100 makes contact with a
substantial portion of the inner surface 704 of the aneurysm 700, as shown in FIGS.
11A-F and 15A-F. In some embodiment, the exterior surface 110 or 124 of the ballstent
100 and 140 makes t with at least 50%, 75%, 90% or more of the inner surface
704 of the aneurysm 700, including up to 100%. In embodiments, the expanded
ballstent 100 and 140 is ed to completely or nearly completely fill the lumen 701
of the aneurysm 700, including up to 100%. In some embodiments, the expanded
ballstent 100 and 140 fills at least 50%, 75%, 90% or more of the volume of the lumen
701 of the aneurysm 700.
In various embodiments of the expandable body 100, 140, 150, or
170A-G, the shape of the expandable body that has been expanded in the lumen of a
blood vessel t is determined, in part, by the formed shape of the expandable
body. For example, in some embodiments, the expandable body 100, 140, 150, or
170A-G is manufactured into a cylindrical, oblong, irregular, or non-spherical orientation
to match the contours of the lumen, void, or cavity for a ular blood vessel segment
or ical conduit segment. The expanded shape is also determined by the size and
shape of the lumen, void, or cavity of the blood vessel segment, or biological conduit
segment. The expanded shape can also be determined by the application of an
external force, such as by inflating the balloon portion of a balloon catheter adjacent to
the expanded ballstent 100, 140, 150, or 170A-G. In other embodiments, the
expandable body 100, 140, 150, or 170A-G is manufactured into a non-spherical
orientation to match the contours of the lumen, void, or cavity for a particular blood
vessel segment, or biological conduit t.
In all embodiments, the expanded shape of the expandable body 100,
140, 150, or 170A-G is ined by the following factors: 1) the manufactured shape
of the expandable body; 2) the degree of able body expansion; 3) the size and
shape of the lumen, void, or cavity of the blood vessel segment, or biological conduit
segment; and 4) the effect of any applied al force on the expandable body after
expansion. By way of example and not limitation, the manufactured size and shape of
the expandable body 100, 140, 150, or 170A-G may be determined by making
measurements of lumen, void, or cavity to be filled. The measurements can be made
by using medical images, including two-dimensional and three-dimensional
tructions, and standard distance reference markers. Other s of
measuring the lumen, void, or cavity may also be used.
In another embodiment, the position, size, and shape of the ed
expandable body 100, 140, 150, or 170A-G can be manipulated and configured or
changed in vivo or even in situ while positioned within the blood vessel segment or
biological conduit. In this embodiment, it is not necessary to determine the e
contours of the lumen, void, or cavity to be filled prior to inserting the expandable body
100, 140, 150, or 170A-G. The expandable body 100, 140, 150, or 170A-G is shaped
by the degree of ion of the expandable body and the application of internal
and/or external forces. For example, an external force may be applied by inflating the
balloon portion of a balloon catheter adjacent to the expanded expandable body, or by
tools ed through or around the ry catheter 400 or guide catheter 800. In
other embodiments, the expandable body 100, 140, 150, or 170A-G may be shaped in a
step prior to or after the step of separating the expanded expandable body from the
ry catheter 400.
In all embodiments, the expandable bodies 100, 140, 150, or 170A-G
are ured to maintain their expanded shapes. As such, the expanded bodies are
not designed for or intended for flattening into disc-like structures before or after
separation from the delivery catheter.
An Example Method of Treatment Using the Expandable Body
By way of e and not limitation, as can be understood from
FIGS. 9, 10A-B, and 11A-F, a first method of using the device 500 or 3400A to treat a
patient may include the steps of examining a patient and collecting stic medical
images to identify a saccular aneurysm. The vascular system may be accessed using
any suitable method including accessing an artery using the Seldinger technique. A
guide wire 302 is then inserted into the vascular system. Then a guide catheter 800 is
inserted into the vascular system and advanced into or near the lumen of the saccular
aneurysm. The position and luminal dimensions of the ar aneurysm are then
visualized by an intra-arterial ion of radiographic contrast solution under
fluoroscopy. The guide wire 302 is removed and the medical device 500 or 3400A is
then inserted through the guide catheter 800 until the compressed ballstent 100 is
advanced into the lumen 701 of the aneurysm 700. The ballstent 100 is then expanded
in the lumen 701 of the aneurysm 700. A radiographic contrast solution may be injected
into the parent vessel 1202 of the aneurysm 700 to confirm that the size of the
expanded ballstent 100 is riate and that it is properly positioned in the aneurysm.
Once proper placement and sizing of the expanded ballstent 100 has been confirmed,
the expanded ballstent is separated from the delivery catheter 400 by any of the
methods disclosed herein, and the delivery catheter is removed. The expanded
ent 100 is left in the t, where uent examination may be conducted to
determine if additional treatment is necessary. The expanded ballstent 100 is left in the
patient functions to reduce the flow of blood into the aneurysm, reduce the risk of
bleeding of the aneurysm, or reduce the risk of expansion of the aneurysm, and as such
it alleviates current medical problems the patient is experiencing or reduces the risk of
future medical problems the patient might experience had the aneurysm 700 not been
treated.
By way of example and not limitation, as can be understood from
FIGS. 13, 14A-B, and 15A-F, a second method of using the device 500 or 3400A to
treat a patient may include the steps of ing a patient and collecting diagnostic
medical images to identify a saccular sm. The vascular system may be
accessed using any suitable method including ing an artery using the Seldinger
technique. A guide wire 302 is then inserted into the vascular system. Then a guide
catheter 800 is inserted into the vascular system and advanced with the guide wire 302
until the guide wire 302 is positioned in or near the lumen of the saccular aneurysm.
The position and luminal ions of the saccular aneurysm are then visualized by an
intra-arterial injection of radiographic contrast solution under fluoroscopy. The guide
catheter 800 is removed and the medical device 500 or 3400A is then inserted over the
guide wire 302 until the compressed ent 140 is advanced into the lumen 701 of the
aneurysm 700. The guide wire 302 is d. The ballstent 140 is expanded in the
lumen 701 of the aneurysm 700. A radiographic st solution may be injected into
the parent vessel 1202 of the aneurysm 700 to confirm that the size of the ent 140
is appropriate and that it is properly positioned in aneurysm. Once proper placement
2014/030869
and sizing of the expanded ballstent 140 has been confirmed, the expanded ballstent is
separated from the delivery catheter 300 by any of the methods disclosed herein and
the delivery catheter is d. The expanded ballstent 100 left in the t
functions to reduce the flow of blood into the aneurysm, reduce the risk of bleeding of
the aneurysm, or reduce the risk of expansion of the aneurysm, and as such it alleviates
current medical ms the patient is experiencing or reduces the risk of future
medical problems the patient might experience had the aneurysm 700 not been treated.
In another embodiment, the able bodies 100, 140, 150, or
170A-G may be rapidly deployed during an emergency. In particular, the expandable
bodies 100, 140, 150, or 170A-G may be deployed rapidly to treat a ruptured cerebral
aneurysm, to immediately reduce ng from the aneurysm.
An Exemplary Method of Treating a Patient Having a Cerebral Aneumsm
A hypothetical method for using the medical device 500 or 3400A to
treat a patient having a saccular cerebral aneurysm may begin with one or more pre-
surgical tations, where a number of tests may be performed. The tests may
include blood tests, urine tests, an electrocardiogram, and imaging tests including a
head CT, a head MRI, and a cerebral ram, among others. From the diagnostic
imaging tests, images, and measurements of the aneurysm may be obtained
demonstrating the position, size, and shape of the aneurysm. The consultations may
occur several days before, or on the same day, that the procedure is performed.
On the day of the procedure, the patient is prepared for the procedure
and typically given local esia. The patient’s groin is then prepped and draped in
an aseptic . Then a physician accesses a femoral artery in the patient with a
micropuncture set. A soft tip guide wire 302 is inserted in a retrograde fashion into the
femoral artery. A vascular sheath is placed. A diagnostic catheter is ed over the
guide wire until the tip of the diagnostic catheter is in the lumen of the saccular cerebral
aneurysm, and the tip of the guidewire is placed in the sm, while the diagnostic
catheter is removed. While the physician is positioning guide wire, a surgical assistant
prepares the ballstent portion 100 of the medical device by wetting the porous exterior
layer 104 of the ballstent with a solution containing thrombin. The medical device 500
or 3400A is advanced over the guide wire and positioned in the lumen 701 of the
aneurysm sac 700. After the ssed ballstent 100 is in the desired position, the
compressed ballstent is expanded by ing a saline solution through the lumen 312
of the ry catheter 300 or 400 and into the central void 108 of the ent until the
ballstent expands to fill at least a portion of the aneurysm. The physician obtains an
angiogram of the aneurysm 700 and the parent artery 1202 by injection of radiographic
contrast material in order to confirm that the expanded ballstent 100 is positioned
properly within the lumen 701 of the saccular aneurysm 700 and fills the aneurysm
adequately. The guidewire is removed and a coil delivery catheter with a pre-loaded
ory coil is passed through the guide wire until its tip has exited the distal end of
the medical device, including exiting from an expandable body, the neck of an
expandable body or a nose cone affixed to an expandable body. The accessory coil is
then expelled from the coil delivery er and into the ed portion of the lumen of
the aneurysm such that the accessory coil makes contact with the wall of the aneurysm
opposite the opening from the parent vessel into the sm lumen and
simultaneously makes contact with the exterior surface of the wall of the expanded
expandable body. Optionally, one or more additional accessory coils can be placed, as
needed.
The physician then connects the proximal end of an electrolysis wire
320 or the insulated conductor wire to a DC power source and applies a current to the
electrolysis wire or insulated conductor wire which is electrically coupled to the neck 116
of the ballstent 100 in an amount, and for a time ient, to result in the dissolution of
a portion of the neck or proximal body 208 of the ballstent that is uncoated and t
insulation, resulting in separation of the expanded ballstent and the ry catheter.
The physician obtains another angiogram of the aneurysm 700 and the parent artery
1202 in order to confirm that the expanded, released ballstent 100 is positioned ly
within the lumen of the saccular aneurysm and fills the aneurysm adequately. The
physician s the delivery catheter 400. The physician advances a balloon
catheter 1100 over the guide wire 302 until the balloon 1102 is adjacent to the
expanded ballstent 100. The balloon portion 1102 of the balloon catheter 1100 is then
inflated with a saline solution until it fills the lumen of the parent artery 1202 and flattens
and pushes the wall 1104 of the expanded ballstent 100 toward the aneurysm 700. The
physician obtains r angiogram of the aneurysm 700 and the parent artery 1202 in
order to confirm that the expanded, released ballstent 100 is positioned properly within
the lumen of saccular aneurysm, fills the aneurysm adequately, and that the lumen of
the parent artery 1202 is free of obstruction. The physician withdraws the balloon
catheter 1100, the guide wire 302, and the sheath and es hemostasis of the
femoral artery puncture with compression. The t is then transported to a recovery
room. During and after recovery, the physician periodically monitors the patient as well
as the position of the ballstent 100 and the completeness of the sealing of the aneurysm
700.
Clinical Examples of Use
Ballstent Treatment
Using a canine model of a large, terminal, carotid artery, venous pouch
aneurysm, a comparison was made between treatment with the ballstent (n = 2) and
ent with standard coils (n = 1).
Methods
The mental model used Canis lupus familiar/s hound cross dogs
weighing about 16 kg. In each dog, a single saccular aneurysm was ally
constructed on a newly created carotid artery terminal bifurcation ing to FIGS.
37A-D, which illustrates ction of the carotid arteries (A), construction of the
terminal bifurcation (B), addition of the saccular aneurysm (C), and the
final configuration of the aneurysm fashioned from a transplanted segment of excised
jugular vein (D). Contrast angiography was med after aneurysm creation
to verify integrity of the aneurysm.
2014/030869
imately 3 weeks after aneurysm creation, an appropriately sized
sheath was placed in a femoral artery via surgical cut-down of the vessel. Heparin was
administered to e a target activated clotting time (ACT) 2 300 seconds. Under
fluoroscopic guidance, a guide sheath (6 Fr x 90 cm long) was advanced into the
al right common carotid artery caudal to the aneurysm. Contrast angiography
was then performed to visualize the lumen of the aneurysm and the parent vessels. A
0.018” guide wire was then placed into the lumen of the aneurysm and the guide sheath
was advanced toward the aneurysm.
For the ent test group, at the time of treatment the aneurysm is
the first animal measured about 12 mm X 9 mm X 6 mm (), while the sm in
the second animal measured about 15 mm x 9 mm x 10 mm. The aneurysm in each
dog was treated with a system ing: a first medical device further comprising a
ballstent expandable body and one or more second medical device(s) comprising an
accessory coil pre-loaded into an ory coil delivery catheter. The expanded form
of the ballstent was spherical. The main body and distal neck of the ballstent comprised
gold while the proximal neck comprised stainless steel with a gold coating or g.
The main body of the ballstent measured 8 mm in diameter (in both the first and second
axis) and was formed from a single layer of gold measuring 20 microns in thickness. A
polymeric nose cone was attached to the proximal neck and also to the distal end of the
delivery catheter. The delivery catheter had an outer er of 3.5 Fr and comprised
two hollow cylindrical bodies or lumens, the first lumen configured for the passage of an
0.018” guide wire or an accessory coil or accessory coil catheter, and the second lumen
configured for the injection of fluid from the proximal hub of the delivery catheter into the
central void of the ballstent, in order to cause inflation or expansion of the ent from
the delivery configuration. The distal portion of the first lumen was defined by a bridging
catheter. The wall of the delivery catheter was formed of polyimide with a PTFE lining
of the lumens, and was reinforced with braided wire. Also embedded in the wall of the
delivery catheter were two insulated conductive wires. One conductive wire was
electrically connected to the ess steel portion of the proximal neck of the ballstent
and was therefore electrically connected to a ring-shaped region of the proximal neck
wherein the exterior surface of this region was comprised of exposed, non-insulated
stainless steel, of the 304 series, further wherein the exposed region was formed by
laser g, to form an anode. A second conductive wire was electrically ted to
a non-insulated ring-shaped electrode comprising um that was mounted on the
delivery catheter, to form a cathode. Both conductive wires were connected to an
electrical jack incorporated into the proximal hub of the delivery catheter. The proximal
neck of the ballstent was coupled to the delivery catheter and held by adhesive, folded
into pleats, and the pleats were wrapped around the distal end of the delivery catheter
and the ng er, and then compressed onto the ry catheter.
The compressed ballstent and delivery catheter was advanced over a
0.018” guide wire, positioned in the aneurysm sac, and then inflated or expanded. The
expanded ballstent was then pulled back to occlude the opening from the parent
vessels into the lumen of the aneurysm sac, including the neck. Expansion of the
ballstent was achieved using saline infused through into a port on the hub and through
the delivery catheter into the l void of the ballstent with an inflation device, while
measuring inflation pressure. The guide wire was then removed and an accessory coil
catheter with a pre-loaded 8 mm diameter accessory coil comprising nitinol was
advanced through the guide wire lumen until the tip of the accessory coil catheter had
passed through the expanded ballstent, through the distal neck, and was in the lumen of
an unfilled portion of the aneurysm n the expanded ballstent and the inner lining
of a wall of the aneurysm generally opposite the opening from the parent vessels into
the aneurysm lumen. The accessory coil was then expelled from the accessory coil
catheter using a nitinol wire as a pusher. After placement, the accessory coil made
contact with both the exterior surface of the ed ballstent and the inner lining of a
wall of the aneurysm generally te the opening from the parent vessels into the
aneurysm lumen, and exerted a force on the expanded ballstent toward the opening
from the parent vessels into the aneurysm lumen. In the first animal one ory coil
was . In the second animal three accessory coils were . To help induce
thrombosis, a small amount of thrombin was injected h an empty coil delivery
catheter and into the unfilled portion of the aneurysm lumen between the expanded
ballstent and the inner lining of a wall of the aneurysm generally opposite the opening
from the parent vessels into the aneurysm lumen. After this, the ory coil ry
catheter was removed and angiography performed to evaluate the degree of aneurysm
occlusion by injection of contrast through the guide catheter. The ballstent was
detached by electrolysis with 2 mA of DC current provided to an electrical jack
incorporated into a port on the hub of the delivery catheter, using a galvanostat system.
Angiography was performed to evaluate the degree of aneurysm occlusion after
detachment of the expanded ballstent and the ry catheter by injection of contrast
through the guide catheter. The guide catheter and sheath were then removed and the
animal recovered.
For the coil test group, the lumen of aneurysm was lly filled with
multiple coils of s sizes (AxiumT'V', en PLC, Dublin, Ireland) sufficient to
reduce the flow of blood into the aneurysm sac, using standard microcatheters and
guide wires, and standard g ques. The on of the coils and the degree
of ion of the experimental sm were evaluated with angiography by injection
of contrast through the guide catheter, including a final angiogram. For both test
groups, contrast angiography was performed immediately after device deployment.
Treatment time, device number and cost, and degree of occlusion at the end of the
procedure were measured. The guide catheter and sheath were then removed and the
animal recovered.
At 4 weeks, an appropriately sized sheath was placed in a femoral
artery via surgical cut-down to the vessel. Heparin was administered to achieve a target
ACT 2 300 sec. Under fluoroscopic guidance, a catheter was advanced into the
proximal right common carotid artery caudal to the aneurysm. Contrast raphy
was then performed to visualize the aneurysm. The animal was then euthanized with
an overdose of pentobarbital and tissue samples collected for histopathology, including
the aneurysm and adjacent portions of the parent vessels.
Results
WO 46001
For the first animal in the ballstent test group, one ballstent and one
accessory coil were placed over a 30-minute treatment period at an estimated cost of
$11,750. The degree of acute occlusion with this ballstent treatment was ted at
100% by angiography (A). Four weeks after treatment, the ballstent showed
sustained occlusion of the aneurysm (8) with well zed, mature, and fully
endothelialized neointima covering the entire aneurysm neck seen on histopathology
().
For the animal in the coil test group, 18 coils were placed over a 60-
minute treatment period at a list price cost of $31 ,500. The degree of acute occlusion at
the end of the coil treatment was ted at 85 - 99% by angiography.
Histopathology is pending for this animal.
Blockstent Treatment
Using a canine subclavian artery occlusion model, a comparison was
made between treatment with the blockstent (n = 3) and treatment with the Amplatzer®
Vascular Plug II (AVP2, n = 3).
Methods
The experimental model used Canis lupus familiaris hound cross dogs
weighing about 20 kg each. The study ed the use of a medical device to place a 6
mm diameter blockstent expandable body in the subclavian / axillary artery on one side
while a guide catheter was used to place a 6 mm AVP2 in the contralateral subclavian/
axillary artery. An appropriately sized sheath was placed in a femoral artery via al
wn of the vessel. Heparin was administered to e a target activated clotting
time (ACT) of 250-300 sec. Under fluoroscopic guidance, a 0.018” guide wire was
advanced beyond the intended occlusion site in the subclavian / axillary . A guide
sheath (6 Fr x 90 cm long) was advanced over the guide wire into the subclavian/
axillary artery. Contrast angiography was then performed to visualize the subclavian /
axillary artery and its side branches.
The blockstent medical device includes a blockstent form of an
expandable body. The ed form of the blockstent was cylindrical, with d
ends. The blockstent had a proximal neck and a distal neck and comprised gold. The
main body of the blockstent measured 8 mm in diameter and was formed from a single
layer of gold measuring 20 microns in thickness. A polymeric nosecone was attached
to the distal neck. The blockstent medical device further comprised a delivery catheter
with an outer diameter of 3.25 Fr that comprised two hollow rical bodies or
lumens, the first lumen for the passage of an 0.018” guide wire and the second lumen
for the injection of fluid from the proximal hub into the l void of the blockstent to
cause inflation or expansion. The wall of the delivery catheter was formed of polyimide
with a PTFE lining and was reinforced with braided wire. The proximal neck of the
blockstent was coupled to the delivery catheter, folded into pleats, wrapped around the
distal end of the delivery catheter and an obturator wire, and compressed. The proximal
neck of the blockstent was held to the distal end of the delivery catheter by an
elastomeric outer sleeve that gripped the neck of the blockstent and formed a friction fit.
After placement of a guide sheath or guide catheter in the proximal
subclavian artery, and the ent of the 0.018” guide wire, the compressed
blockstent and the delivery catheter were advanced over the guide wire positioned in
the axillary / subclavian artery and then inflated or expanded. Angiography performed
to te the degree of artery occlusion by injection of contrast through the guide
sheath or guide catheter. The tip of the guide sheath or guide catheter was ed
rd until it was touching the proximal end of the ed blockstent. The delivery
catheter was pulled back, resulting in mechanical detachment of the expanded ent
from the delivery catheter by disengaging the proximal neck of the expanded blockstent
from the elastic sleeve on the distal end of the delivery catheter. The position of the
expanded, detached blockstent and the occlusion of the target vessel were confirmed
with angiography and the guide wire d.
For the AVP2 treatments, the guide wire was removed and exchanged
for the AVP2, with care taken not to twist the device’s delivery wire. The distal end of
the AVP2 was oned at the distal edge of the intended occlusion site. The guide
2014/030869
sheath or guide catheter was then pulled back to expose the AVP2, resulting in
expansion. The position of the expanded device was confirmed with angiography. The
AVP2 was then detached by unscrewing its ry wire. The position of the
expanded, detached AVP2 was confirmed with angiography and the guide sheath
removed along with the delivery wire.
For both treatments, contrast angiography was performed immediately
after device deployment. The treated vessel segment was monitored with serial
angiography every 2.5 s for the first 30 minutes or until occlusion was observed.
At 29 days, an appropriately sized sheath was placed in a femoral
artery via surgical cut-down to the vessel. Heparin was administered to achieve a target
ACT 2 300 sec. Under fluoroscopic guidance, a guide sheath (6 Fr x 90 cm long) was
advanced into the subclavian artery. Contrast angiography was then performed to
visualize the artery and its side branches. This s was then ed on the
contralateral side. The animal was then euthanized with an se of pentobarbital
and tissue samples collected for histopathology, including the aneurysm, the implanted
ballstents, accessory coils, and Axium coils, and adjacent portions of the parent
vessels.
Results
A summary of the angiography results for each device is provided in
. The blockstent demonstrated excellent fluoroscopic visibility, good trackability,
low re (1-3 atm) ion, and reliable detachment. Rapid occlusion achieved
in 3/3 es with the blockstent and 3/3 arteries. All animals survived to the
scheduled Day 29 termination. Complete occlusion was maintained at 29 days in 3 of 3
arteries with the blockstent (100%) and 0 of 3 arteries with the AVP2 (0%). All of the
blockstent-treated arteries were also fully occluded by histopathology, with little
inflammatory response or -related damage to the vessel wall, as shown in . Partial blockstent deformation occurred over time, possibly caused either by issue
ingrowth or ssion n dog’s forelimb and chest wall, but this deformation
had no effect on the blockstent’s ability to completely and permanently occlude the
WO 46001
target artery t. None of the AVP2 treated arteries were fully occluded at 29
days by histopathology.
It will be appreciated that the devices and methods of the present
invention are capable of being incorporated in the form of a variety of embodiments,
only a few of which have been illustrated and described above. The sures herein
may be embodied in other specific forms without departing from its spirit or essential
characteristics. The described embodiments are to be considered in all respects only
as illustrative and not ctive and the scope of the present invention is, therefore
indicated by the appended claims rather than by the foregoing description. All changes
that come within the meaning and range of equivalency of the claims are to be
embraced within their scope.
Claims (17)
1. A system of medical devices comprising: a first medical device comprising: (i) an expandable body configured for location in a lumen of a ar aneurysm defined by an inner wall e of the sm, the expandable body further comprising: a main body comprising a wall defining an exterior e of the expandable body and an or surface of the expandable body, the interior surface defining a central void of the expandable body; the main body configured to assume a single lobed shape with expansion; wherein, when expanded, the expandable body is configured to reduce the flow of blood into the lumen of the sm subsequent to the expanded expandable body being d in the lumen of the aneurysm; wherein the expandable body is configured such that when the expandable body is expanded in the lumen of the aneurysm, the expanded expandable body is in contact with a first portion of the inner wall surface of the aneurysm while an unfilled area remains between the expanded expandable body and a second portion of the inner wall surface of the aneurysm opposite an opening from a parent vessel into the lumen of the aneurysm; (ii) a catheter delivery device comprising a udinally extending body comprising a proximal end and a distal end generally opposite the proximal end, the distal end of the catheter delivery device being operably coupled with the expandable body, and, a second medical device comprising: (iii) a wire, configured as a coil, and further configured for passage through the catheter delivery device and the expandable body, wherein: a) the distal end of the wire is configured for placement in the lumen of the aneurysm; and b) the proximal end of the wire is configured for placement in the central void of the expanded body.
2. The system of Claim 1 wherein a distal neck of the able body comprises a nose cone to reduce friction when the first medical device is advanced forward.
3. The system of Claim 1 wherein the wire comprises nitinol, platinum, stainless steel, or gold.
4. The system of Claim 1 wherein the coil is generally round, oval, or spheroid in shape.
5. The system of any one of Claims 3 or 4 wherein the wire is ured as a three-dimensional uct having a volume equal to n 50 mm3 and 300 mm3.
6. The system of any one of Claims 1 - 5 wherein the coil is a sphere having a diameter of 8 mm.
7. The system of Claim 1 wherein the coil is a spheroid approximately 8 mm x 4
8. The system of Claim 1 wherein the coil has a diameter of 4 mm, 5 mm, 6 mm, 7 mm, or 8 mm.
9. The system of Claim 1 wherein the wire has a ess ranging between 0.002 inches and 0.015 inches.
10. The system of Claim 1 wherein the wire has a thickness ranging between 0.005 inches and 0.014 inches.
11. The system of Claim 1 wherein the wire has a thickness of 0.002, 0.003, 0.004, 0.005, 0.006, 0.007, 0.008, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014, or 0.015 inches.
12. The system of any one of Claims 1 or 3 - 11 wherein the wire is coated with PTFE.
13. The system of any one of Claims 1 or 3 - 12 wherein the wire comprises a radiopaque marker.
14. The system of Claim 13 wherein the radiopaque marker comprises a metal.
15. The system of any one of Claims 4 - 14 wherein: the longitudinally extending body of the catheter delivery device is a first catheter; and the passage of the wire is enabled by the ent of a second catheter through the first delivery catheter, such second catheter enabled for the passage or placement of the wire.
16. The system of Claim 15 wherein the second catheter has an outer er of 0.014, 0.015, 0.016, 0.01, 0.018, 0.019, 0.020, 0.021, or 0.022 inches.
17. The system of Claim 15 wherein the second catheter has an inner lumen er of 0.008, 0.009, 0.010, 0.011, 0.012, 0.013, 0.014, 0.015, or 0.016 inches. WO 46001
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361793737P | 2013-03-15 | 2013-03-15 | |
US61/793,737 | 2013-03-15 | ||
NZ743283A NZ743283A (en) | 2013-03-15 | 2014-03-17 | Expandable body device and method of use |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ751788A NZ751788A (en) | 2020-11-27 |
NZ751788B2 true NZ751788B2 (en) | 2021-03-02 |
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