WO2011076390A1

WO2011076390A1 - Device for placing a medicinal implant and arrangement comprising said type of device

Info

Publication number: WO2011076390A1
Application number: PCT/EP2010/007845
Authority: WO
Inventors: Giorgio Cattaneo
Original assignee: Acandis Gmbh & Co. Kg
Priority date: 2009-12-23
Filing date: 2010-12-21
Publication date: 2011-06-30
Also published as: DE102009060279A1; DE102009060279B4

Abstract

The invention relates to a device for placing a medicinal implant (10) in a body cavity, comprising a supply element (11), a maintaining surface (13) for the implant (10) which is embodied on one end (12a) of the supply element (11), the end (12a) comprising the maintaining surface (13) can be placed in the body cavity and the maintaining surface (13) is adapted in such a manner that said implant (10) can be detached from the maintaining surface (13) for releasing in the body cavity.

Description

Device for supplying a medical implant and arrangement with such a device

description

The invention relates to a device for supplying a medical implant having the features of the preamble of claim 1. Such a device for releasing a stent in a vessel is known for example from EP 1374801 AI. The invention further relates to an arrangement

comprising a device for delivering a medical implant into a body cavity, in particular into a vessel, and a medical implant.

Typically, when implanting a stent, an application system in the form of a catheter is placed in the vascular area to be treated, with the stent retained within the catheter tip, usually due to the radial restoring force generated by the compression of the stent, which is on the

Inner wall of the catheter acts. In the target vessel, a relative movement between the stent and the catheter tip causes the stent to be released from the stent

Application system. In strongly tortuous vessels, good catheter flexibility requires relatively high flexibility and, in addition, sufficiently high axial stability for moving the catheter in the vessel. A related improvement of existing application systems is in the old, post-published patent application to the applicant

DE 10 2009 023 661.9, which has a catheter tip with an inner wall which tapers in the distal direction from the applicant. With this advancement, the loading of the vessels occurring during implantation of a stent can be reduced.

However, there is a widening of the vessel diameter due to the catheter wall. This is the case especially for small vessels. For example, if an uncrimped stent with a certain outside diameter is implanted, the overall diameter of the system will be at least the outside diameter of the stent plus twice the wall thickness of the stent Catheter. Since the stent is usually oversized relative to the inner diameter of the vessel, increasing the diameter of the application system due to the catheter makes the vessel relatively strong during implantation

claimed. By crimping the stent, the system diameter can indeed be reduced. The ability to introduce the stent in the crimped state by a catheter but is very small vessels, for example, in vessels with

Dimensions in the range of 100 μηη not easily feasible. Further

Limitations on crimping may result from struc- tures or stent designs that are inappropriate for the implanted state.

The invention is based on the object to provide a device for supplying a medical implant, which is reduced in terms of a

Stress of the vessel when implanting or when dismissing the implant from the device is improved. The invention is further based on the object to provide an arrangement with such a device.

According to the invention, the object with regard to the device by the

The subject matter of claim 1 and with regard to the arrangement by the

Subject of claim 13 solved.

The invention is based on the idea, a device for supplying a

indicate medical implant in a body cavity with a supply element, wherein at one end of the supply element, a holding surface for the implant is formed. The end with the support surface is placeable in the body cavity, wherein the support surface is adapted such that the implant is releasable from the support surface for release in the body cavity. The holding surface is formed on an outer periphery of the feed element. The feed element has at least one hollow channel which extends into the region of the holding surface and is connected to at least one, in particular with a plurality of openings, which are formed in the holding surface. The hollow channel is connected to a suction device and / or a pressure device or connectable and forms a suction line and / or a pressure line such that the implant in use with a

Holding pressure for fixing the implant to the feed element and / or with a

Release pressure for releasing the implant can be acted upon. In contrast to known application systems, the device according to the invention provides the prerequisite for the implant being detachably connected to the feed element on the inner surface of its wall. Thus, the conventionally required in the prior art fixation of the implant to the

Outer surface of the implant wall omitted by the inside of the catheter tip. The device thus allows a particularly space-saving mounting for an implant, which is easily solvable in the region of the target vessel to be treated. The outer diameter of the application system in the region of the implant holder is thus determined in use by the outer diameter of the implant.

Compared with known application systems, the system diameter in the region of the implant holder can be reduced by about twice the previous catheter wall.

The outer profile of the feed element is usually cylindrical. Other external profiles of the feed element are possible. The outer profile of the feed element can essentially correspond to the inner profile of the implant. geometric

Deviations between the inner profile of the implant and the outer profile of the implant

Feed element are possible.

The holder or the fixation of the implant on the feed element is effected by a negative pressure or a suction effect, which is generated by the user from the proximal and outside of the body. Due to the negative pressure, the implant is sucked in the region of the holding surface to the feed element and thereby fixed. In use, the implant is thus subjected to a holding pressure for fixing the implant to the feed element. By releasing the negative pressure or the

Holding pressure, the fixation of the implant can be easily solved.

As a pressure transfer medium, a liquid, for example. NaCl solution can be used.

The negative pressure is generated by the suction device, which is connected to the hollow channel in the feed element. The hollow channel extends in the region of

Holding surface and is connected to at least one, in particular a plurality of openings which are formed in the holding surface. As a result, the negative pressure is transmitted to the outer circumference of the feed element, so that in the region of Holding surface arranged implant is sucked at least partially to the feed element and thus fixed.

For a sufficient fixation, it is not necessary that the implant rests on the entire circumference of the holding surface, where this is possible. It may be sufficient for a partial region of the inner surface of the implant wall to cover one or more of the openings formed in the holding surface, so that the negative pressure in this region acts on the implant wall and exerts the holding force.

With the device according to the invention also implants can be supplied, whose inner diameter is slightly larger than the outer diameter of the

Holding area. This facilitates the removal of the delivery member from the implant once the vacuum is removed. In the above-mentioned eccentric positioning or fixation of the implant relative to the

Feed element, is only a portion of the inner surface of the implant wall on the support surface and covers the openings formed there. In this case, it is also possible to form the openings mainly or exclusively on the side of the holding area where the eccentrically positioned implant on the

Holding surface is applied. This is, for example, the holding situation for a cylindrical implant, such as a stent and a cylindrical feed element, whose outer diameter is slightly smaller than the inner diameter of the implant, in particular stents.

The hollow channel is alternatively or additionally connected to a pressure device or connectable such that the hollow channel forms a pressure line and can act on the implant to assist the release with a release pressure. This improves the safe and reliable discharge of the implant from the delivery system. The pressure transfer or the transmission of the release pressure takes place in the same way as the vacuum transfer, namely on the openings provided in the holding surface. This will cause the inner surface of the

Applied to the implant wall with a pressure, so that a radially outward release force acts on the implant wall. As a medium for the

When pressurized, a liquid such as a NaCl solution may be used. The supply of the liquid associated with the overpressure transfer further causes the delivery element to not only be better off Implant triggers, but also slides better along the implant, if that

Implant is positioned in the target vessel. A separation of the feed element and the implant is thus possible in a particularly safe and reliable manner. The release pressure functionality may be combined with a mechanical fixation of the implant instead of the suction fixation. In this alternative embodiment, the mechanical fixation is realized, for example, by a press fit between the implant and the holding surface of the feed element. By acting on the flexible implant wall with the release pressure, it is widened, so that the delivery element can be removed from the implant. The released implant remains in the target vessel. Due to the mechanical fixation of the implant, the formation of the hollow channel as a pressure line is sufficient. The suction line is not mandatory.

It is also possible to combine the release pressure functionality and the suction functionality, so that both the fixation and the release of the implant takes place by pressurization, in particular by exposure to overpressure and underpressure.

The pressure transmission can be done by one and the same line, in particular the hollow channel, since this takes place separately in time. It is also possible to provide a plurality of hollow channels, which have different functions, wherein, for example, a first hollow channel acts as a pressure line and a second hollow channel as a suction line. Further hollow channels can be provided, for example for the drug supply.

The device according to the invention has the advantage that the feed element with the holding surface for the implant does not necessarily have to be arranged in a catheter, but at least in sections, in particular in the region of the

Implantatfixierenden end of the delivery member can be supplied catheter independent in the target vessel. Other, more proximally located areas of the

Device may be guided in a catheter. Thus, the device according to the invention can also be used in connection with a catheter, wherein very small vessels can be achieved by the catheter-independent fixation of the implant on the inner surface of the implant wall. For this purpose, the distal end portion of the device, ie the feed element with the holding surface beyond the catheter tip also be advanced in the distal direction, so that the advantage of the small diameter of the application system comes into effect. This means that per se conventional catheters, which are designed for the transport of a liquid or a device in the inner lumen, can continue to be used in connection with the device according to the invention, wherein the advantage of the device according to the invention is that the positioning of the

Implant is not limited to the end portion of the catheter, but also is effective through the catheter-independent fixation on the feed element. The delivery element can thus be pushed out beyond the tip and fixes the implant independently of the catheter.

The device according to the invention is also suitable for the transcutaneous treatment of nearby vessels, especially in the eye. For supplying the medical implant in the body cavity, in particular in the vessel, this can be punctured by means of the device according to the invention, and advantageously at a location which is close to the site to be treated.

In general, the device according to the invention is useful for endoscopic applications. By an endoscope, in contrast to a catheter, we mean a somewhat stiffer system than a catheter, but it can also have a certain flexibility. An endoscope is usually not designed to transport a liquid or device in the inner lumen. Endoscopes are also usually sterilizable systems and have a higher mechanical stability. They are also shorter than catheters, which are usually delivered through longer cavities. Thus, the aspect ratio length / thickness is smaller in endoscopes than in catheters. In the treatment of an eye may be more of a

endoscopic use, because the vessel to be treated is very close to the main and the application system should be rather stiff. In the case of the telescopic embodiments of the invention disclosed elsewhere, which are intended for passage through peripheral vessels, one may rather refer to a

Be spoken catheter application. Ultimately, in both cases are devices for the supply of medical implants in a hollow body organ, in particular in a vessel. In this application, when endoscopic treatments are addressed, generally the above mentioned. constructional and

meaning handling-related features, wherein the transport or supply of an implant is the goal of the device. A further advantage of the device according to the invention, in particular of the delivery element in relation to the application of implants through catheters, relates to the ratio wall / inner diameter of the delivery system. In conventional catheters, the wall should be as thin as possible, thereby providing more space for the implant without increasing the outside diameter of the catheter. However, the thin wall of the catheter can lead to collapse of the system. Therefore, catheters are made of multiple layers of different materials and braiding / coil reinforcement. However, such systems are very expensive. In addition, the stability of such a system, despite the

Reinforcements continue to be inadequate. The application system according to the invention has the advantage that the lumen can be made much smaller in relation to the overall diameter of the system than in known systems. Thus, the ratio wall thickness / outer diameter is greater than in known systems. It is not a large lumen of the hollow channel required to the negative pressure or,

For example, to effect a sufficient supply of drugs or liquids through the delivery member. The inventive system or the

The device according to the invention is therefore more stable than known application systems and can be produced, for example, from a single material without increasing the risk of collapse or breakage. The production of different materials is not excluded.

In the context of the invention, the device for supplying a medical

Implant both without the implant (claim 1) and with the implant in the form of an arrangement comprising such a device and a medical implant (claim 14) discloses and claims.

In a preferred embodiment, radially arranged side channels are provided which connect the hollow channel and the openings in the holding surface.

As a result, the transmission of the negative pressure from the hollow channel to the holding surface of the feed element is achieved in a simple manner.

The delivery member may include a tip that is disposed distal to the support surface by the user and configured to urge a calculus, particularly a thrombus, through the tip to the vessel wall in use and / or to puncture a vessel or tissue. This facilitates the placement of the holding surface with the fixed implant adjacent to the thrombus. It is also possible to use the sharp tip for puncturing. Preferably, the tip in longitudinal section two, with respect to the longitudinal axis of the feed element, differently inclined sides or a side parallel to the longitudinal axis of the feed element and an oblique side. This will increase the manageability of the

Improved delivery element in the vessel, since the distal end of the tip is arranged as close to the vessel wall, when the tip is moved past the thrombus. The delivery member may have more flexibility at its tip than in a user-proximal portion of the delivery member.

This makes it possible to move the supply element from the applicant or generally from a proximal position out with good transmission and to

maneuver, with the flexible tip allowing adaptation to the vessel / cavity geometry. The different flexibility ranges of the

Feed elements can be achieved by the combination of different materials, which are explained in detail elsewhere, and / or by geometric relationships. For example, the feed element can have a user-proximal region that has a larger diameter than a distal region of the delivery element, in particular a distal region, which is adjoined by the tip.

In a further preferred embodiment, the hollow channel with a

Supply device for medication and / or fluids connected or

connectable, such that the hollow channel both a suction line and a

Drug delivery and / or hydration forms. This has the advantage that the hollow channel fulfills two functions, namely the suction and / or pressure function as well as the drug supply and / or fluid supply, whereby the versatility of the application system or the device for supplying the medical implant is extended. Preferably, the hollow channel has an outlet opening for the

Drug supply / fluid supply, which is provided at the end of the feed element. This has the advantage that the used for the treatment

Drugs can be released directly in the target vessel.

The hollow channel may comprise at least one valve which the openings of

From the user's point of view, it is located downstream or proximally upstream and closes the hollow channel during suction or pressure operation. This prevents blood from entering the hollow channel in the suction mode or the medium in the hollow channel exits in printing operation, for example, by a possible outlet opening for the drug delivery.

The hollow channel may have at least one further opening, which is formed at the end of the feed element for sucking and holding a concretion, in particular a thrombus. The embodiment has the advantage that, by sucking and fixing the thrombus on the delivery element, it may possibly be mechanically removed from the vessel. If this is not possible, then the implant, as originally provided, can be placed in the target vessel to the

Thrombus to press the vessel wall and open the vessel.

The feed element with the holding surface and at least one first hose-like feed element can be arranged telescopically in one another. This embodiment is particularly suitable for the treatment of remote vessels, in which only in the last section in front of the target vessel, the reduced outer diameter of the application system is significant. In this case, the first supply element and at least one second hose-like supply element can be arranged telescopically displaceable one inside the other, whereby the length of the device can be increased. The feed element preferably has a varying diameter, namely a diameter which changes in the longitudinal direction of the feed element. The diameter of the feed element is in the proximal direction, ie to

User bigger. This facilitates the feedability of the feed element. This will be described in connection with the two subsequent embodiments and in the event that the supply element reaches the user and in the event that the supply element is shorter and by a pusher in the

Catheter is moved.

The supply element with the holding surface may be formed in its length so that a user-viewed from the proximal end of the feed element in the fully extended state by the user is actuated. Thus, at maximum length, ie at fully telescoped telescoping feed elements, the proximal end of the feed element with the holding surface of the user tangible.

This facilitates or simplifies the handling or actuation of the feed element with the holding surface for the implant. At the catheter end, a stop may be formed, the function of which is the inner element, for example, the feed element in its axial extension movement block when the predetermined extension stroke of the feed element is reached with the holding surface.

The feed element with the holding surface can be arranged to be relatively movable in a line, in particular in a catheter, wherein the hollow channel formed in the feed element is either connected or connectable by the line to the suction device and / or the pressure device and / or the drug supply device. In this embodiment, a conventional catheter may be used to guide the delivery member to the support surface, with the delivery member being moved with the support surface, for example, by a pusher. The direction of the catheter has two functions. On the one hand, the line serves the mechanical guidance of the feed element, on the other hand the line connects the hollow channel in the feed element with an actuating device, which is outside the line

is arranged, for example with a suction device, and / or a

Printing device, and / or a drug delivery device. The sealing of the feed element against the inner surface of the conduit of the catheter takes place in a manner familiar to the person skilled in the art.

The invention is further based on the idea to provide an arrangement comprising a device according to the invention and a medical implant which can be fixed in the region of the holding surface on the feed element, wherein the implant has a wall with at least one holding and / or release region, which in

Use at least one opening in the holding surface covered and with a

Holding force can be acted upon, which is generated in use by the suction effect. The holding force acts radially inwards. For the holding and / or release area or the suction area each area closed surface of the wall is suitable. Also, a wall with a porous structure can by the

Be sucked intake element. For example, the porous structures or the holding and / or release region of the implant can be smaller than the openings in the holding region or in the holding surface. In this case, the openings are partially closed and partially uncovered. The suction effect can be achieved under these conditions that the size of the openings, in particular their

Diameter, is adapted so that due to the surface tension in the open, uncovered areas of the openings no liquid is sucked into the hollow channel. Thus, a pressure loss is prevented and on the

Implant wall acts as required for the fixation of the implant holding force. By a porous structure is meant, for example, a film with very fine perforations.

It is not necessary that the entire wall is closed continuously, also an embodiment of the implant with a continuous closed wall in connection with the invention is disclosed. It is sufficient if the suction of the wall has a slightly larger diameter

have, as the openings formed in the holding surface, so that the openings can be completely covered by the suction and thus subjected to a negative pressure. The assignment of the suction regions or the holding and / or release regions of the implant wall to the openings in the holding surface can be effected either by an alignment of the implant on the holding surface, such that the holding and / or releasing regions or at least a part of the holding and / or release areas are aligned with the openings. It is also possible to achieve sufficient coverage of the openings in the support surface by a large number of openings and holding and / or release areas, so that statistically the probability of overlap is sufficiently high. Thus, the holding and / or release areas and the openings formed in the holding surface can be designed statistically or by the geometric arrangement such that the

Probability of (partial) coverage is 100%.

In principle, a single opening, which cooperates with a suction region or a holding and / or release region of the implant wall, is sufficient for fixing the implant. Preferably, a plurality of openings in the holding surface

provided, which cooperate with a correspondingly large holding and / or release area or with a plurality of small holding and / or Lösebereichn. The openings may be arranged distributed in the longitudinal direction and / or circumferential direction of the feed element.

The holding and / or releasing area is a region of the wall which is suitable for being pressurized in such a way that a radially inwardly directed force (holding force) and / or a radially outward force (releasing force) acts on the wall ,

In the preferred embodiment, the wall comprises a

rotationally symmetrical, in particular a cylindrical wall, the rigid or is flexible. The flexible wall may have a longitudinal slot. The rigid implant wall is suitable for particularly small vessels where the implant diameter is so small that crimping of the implant is not possible. The flexible implant wall is suitable for slightly larger vessels, where a reduction in the diameter of the implant by the suction and / or by crimping the implant is possible.

The flexibility of the wall can be achieved for example by a longitudinal slot formed in the wall, through which the wall can be widened or reduced in diameter. The wall may alternatively or in addition to the longitudinal slot be structured by a perforation, wherein the ratio between the material surface and the entire wall surface more than 20%, in particular more than 30%, in particular more than 40%, in particular more than 50%, in particular more than 60%, in particular more than 70%, in particular more than 80%, in particular more than 90%. Through the perforation is the

Improved longitudinal expansion of the implant wall.

The term flexibility is both the flexibility of the wall in

Circumferential direction, as well as the flexibility of the wall understood in the longitudinal direction. The flexibility of the wall in the circumferential direction is made possible for example by the longitudinal slot in the wall and allows a kind of crimping of the implant to very small diameter. The flexibility in the longitudinal direction is to be understood in the context of the curvature of the implant, which can occur, for example, in tortuous vessels. The flexibility of the wall for such curvatures is made possible, for example, by the perforation, which supports an extension of the structure or the implant on the curved outer diameter.

The invention will be explained in more detail below with reference to exemplary embodiments with reference to the attached schematic drawings with further details. In these show:

1 shows a longitudinal section through a feed element of a device according to an embodiment of the invention, in which a

Implant is arranged on the holding surface;

Fig. 2, the feed element of FIG. 1 when connecting to a

a crimped implant placed in an introducer sheath; a cross section through the feed element of FIG. 1 with

fixed implant and with dissolved or released implant in the target vessel; the supply element of Figure l in three different states when removing an implant located in the vessel. a plan view of a unwound implant with perforation in the unstretched and in the longitudinally stretched state; a longitudinal section through the supply element of a device according to another embodiment of the invention in the treatment of a thrombus; a cross section through the supply element of a device according to another embodiment of the invention, in which the tip fulfills a suction function; a longitudinal section through a supply element of a device according to another embodiment of the invention, which is telescopic; and the arrangement of the feed element according to FIG. 8 in vessels of different size with different bifurcations.

In Fig. 1, an embodiment of the device according to the invention is shown, which is particularly suitable for the treatment of vascular occlusions or -Verengungen by implants, or by vascular supports, such as stents. With the device, other implants can be supplied. The device is particularly suitable for the treatment of vessels with a diameter of less than 300 pm, in particular less than 200 pm, in particular less than 150 μm, in particular less than 100 pm, without being restricted thereto.

The device of FIG. 1, for example, for the treatment of Arterienbzw. Venous occlusion can be used in the eye area. A closure in the Eye area can occur for two main reasons. On the one hand, a thrombus occludes the vessel, either in the artery or in the vein. On the other hand, you can press an artery against the vein and close it. The invention is not limited to this application nor to those mentioned above

Dimensions limited. Rather, the invention can also be used successfully for the treatment of vessels or cavities with a larger diameter or for other medical applications.

The embodiment of FIG. 1 shows in longitudinal section the supply element 11 of a device according to an embodiment of the invention. The

Device may include other elements, such as ports or

Actuators that are connected to the illustrated feed element 11 or cooperate with this. In particular, the delivery element 11 may be proximal with tubes, especially tubes with larger ones

Diameter as the feed element 11, or be connected to other supply and handle elements (not shown). The device can also only from the

Feed element 11 exist. The delivery member 11 is that part of the device that is placed in the target vessel to deliver the implant 10 there. For this purpose, one end, in particular a first end 12a of the feed element 11, has a holding surface 13 for the implant 10. The first end 12a of the delivery member is distally positioned as seen by the user, or forms the distal end.

The term distal refers to more distant from the user components or sections of an element. The term proximal designates closer to the user arranged components or sections of components.

The feed element 11 is an elongate, rotationally symmetrical, in particular cylindrical body which can be actuated or handled by the user.

for example, for puncturing a vessel or for an endoscopic

Application. The feed element 11 forms the last or outermost element of the application system distally from the user, which is guided to the target vessel.

The delivery member 11 has a distal end 12a and a proximal end 12b. In the region of the distal end 12a or at the distal end 12a of the feed element 11, a holding surface 13 for the implant 10 is provided. The length of the holding surface 13 corresponds approximately to the implant length or is slightly longer. The holding surface 13 forms the seat of the implant 10 during insertion into the vessel. In the simplest case, the feed element 11 has a constant diameter over its entire length, ie also at the level of the holding surface 13. It is also possible, as in

Embodiment according to FIG. 1 illustrated that the outer diameter in the region of the holding surface 13 is smaller than the outer diameter in a proximal region of the feed element eleventh

As shown in Fig. 1, the holding surface 13 on the outer periphery of the

Feed element 11 is formed. This causes the fixation of the

Implant 10 takes place on the inner surface, which rests at least partially on the support surface 13. Thus, the outer diameter of the implant 10 determines the total diameter of the application system in the region of the holding surface 13. The outer diameter of the overall system is therefore smaller than in innenfixierenden catheters.

The circumferential profile of the holding surface 13 is to be fixed to the inner profile of the

Implant 10 adapted. In the embodiment of FIG. 1 is the

Circumferential profile of the holding surface 13 rotationally symmetrical, in particular cylindrical. Other profile shapes are possible.

With regard to the dimensions, for example, the inner diameter of the implant may be slightly larger than the outer diameter of the feed element 11, in particular the holding surface 13 of the feed element 11. This further facilitates the removal of the feed element 11 from the implant 10. It is also possible that the inner diameter of the implant and the outer diameter of the feed element 11, in particular in the region of the holding surface 13 is the same. It is even conceivable that there is a press fit between the implant and the holding surface 13 when the implant is radially deformable, for example by a perforation or by a longitudinal slot. In this case, the release of the implant 10 is facilitated or made possible by an acting pressure. It is also possible that the friction of the vessel wall is greater than the friction between the implant and

Feed element 11 to strip the implant 10 from the feed element 11. For this purpose, acting as a stop transition region 27 shown in FIG. 1 is advantageous

(mechanical fixation). The implant can be moved distally, with both the negative pressure and the stop preventing the implant from getting in

moves in the proximal direction. The dismissal takes place by interrupting the Negative pressure and pulling the feed element against the friction of the vessel wall. The friction can be achieved either by a corresponding surface and / or structuring of the feed element 11 or by the pure overstretching of the vessel.

This means that the holding function can be achieved in various ways, for example, by an exclusively mechanical fixation of the implant or by a combined mechanical and negative pressure assisted fixation or by an exclusively vacuum-assisted fixation of the implant.

The holding function of the feed element 11 is achieved by at least one hollow channel 14 which is formed in the feed element 11. The hollow channel 14 extends from the proximal end 12b of the feed element 11 in the region of the holding surface 13. The hollow channel 14 is accessible at the proximal second end 12b through an inlet opening 25. The inlet opening 25 is on the front side of the feed element 11 in the region of the proximal End formed 12b. The hollow channel 14 extends coaxially to the longitudinal axis of the feed element 11. It is also possible to arrange the hollow channel 14 off-center relative to the longitudinal axis of the feed element 11.

The hollow channel 14 extends in the region of the holding surface 13 and is formed into a region below the holding surface 13. In the embodiment shown in FIG. 1, the hollow channel 14 extends almost over the entire length of the support surface 13. It is also possible to form the hollow channel 14 shorter, such that it does not complete the support surface 13, as in Fig. 1, but only partially overlapped.

There are also several hollow channels possible, for example, a channel for sucking

(Suction line) and a channel for conveying (pressure line), so that a

Function separation takes place

The hollow channel 14 is connected to a plurality of openings 15 which are formed in the holding surface 13. The openings 15 allow fluid communication between the hollow channel 14 and the inner surface of the implant 10, which is fixed on the feed element 11. As shown in Fig. 1, a plurality of openings 15 are provided along the longitudinal direction of the holding surface 13. In the embodiment according to FIG. 1, concretely 12 openings 16 arranged in a longitudinal plane are formed in the holding surface 13. Another number of openings 15 in the longitudinal direction of the support surface 14 is possible. For example, in principle, a single opening 15 may be sufficient. In particular, at least 2, at least 3, at least 4, at least 5, at least 6, at least 7, at least 8, at least 9, at least 10, at least 11, at least 12 openings 15 may be provided in the longitudinal plane. As shown in FIGS. 3a, 3b, a plurality of openings 15 are also provided in the circumferential direction of the feed element in the region of the holding surface, for example, eight openings distributed over the circumference may be provided in a cross-sectional plane. Again, different numbers of openings 15 are possible, with reference to the disclosure of the number of openings in connection with the above-mentioned longitudinal arrangement of the openings.

The openings 15 may be circular. Other opening profiles, such as oval or slot-shaped are possible.

The openings 15 are connected to the hollow channel 14 by side channels 16 which extend radially between the hollow channel 14 and the openings 15 in the feed element 11. The hollow channel 14 is closed at the distal end 12 a, so that the entire suction power is applied to the holding surface 13. The distal closure of the hollow channel 14 is effected in a simple manner by a closed end face 26 in the region of the distal first end 12a.

The hollow channel 14 is connected to a suction device not shown in FIG. 1 or connectable and forms a suction line. By the suction device, a negative pressure is generated, which is transmitted through the hollow channel 14 and the side channels 16 to the openings 15 and thus to the support surface 13. Due to the resulting suction, the implant 10 is fixed in use on the feed element 11. In FIG. 1, a gap is drawn between the implant wall and the holding surface 13 for reasons of illustration. In practice, the implant wall abuts against the holding surface 13. It is also possible that the implant wall rests only in regions on the holding surface 13, wherein in the adjacent region of the implant wall, the fixing holding force is applied to the implant 10. A gap existing between the remaining area of the implant wall and the holding surface 13 is harmless.

Even in the areas where a gap exists, a suction effect can be caused by the negative pressure. Due to the small dimensions of the gap can be achieved that no liquid penetrates into the line because of the surface tension. It is possible that the implant rests only at certain points on the holding surface. It is possible that the gap extends over the entire circumference. The gap is formed by an angle of 360 °. For example, the implant abuts only at the ends of the implant. In general, the holding and / or release area of the wall can be interrupted both along the length and along the circumference.

Reducing the entire area where the implant rests reduces implant removal force when the vacuum is broken and the delivery member is pulled proximally.

The holding and / or release region of the wall generally forms the contact surface between the implant 10 and the feed element 11 or holding surface 13.

The delivery member 11 has a tapered in the distal direction,

in particular conically tapered transition region 27. The transition region 27 can for example serve as a stop in a telescopic system which limits a longitudinal movement of the feed element 11. Furthermore, the

Transition region 27 when loading the application system with the implant act as a stop for the implant 10. In the embodiment according to FIG. 1, the transitional region 27 connects the distal end 12a to the holding surface 13 and the proximal end 12b, in which the hollow channel 14 is formed. Of the

Outer diameter of the proximal end 12 b is larger than the outer diameter of the distal end 12 a with the holding surface 13.

The feed element 11 may also be referred to as a tube.

In the embodiment according to FIG. 1, the implant is loaded in the uncrimped state. It is also possible, as shown in Fig. 2, the implant on the

To crimp tube or on the support surface 13 of the feed element. In this case, as illustrated by the arrow in FIG. 2, the system is crimped before use within an external sluice or introducer sheath 28. The implant, in particular the stent is held in the introducer sheath 28 and the holding surface 13 is inserted together with the distal end 12 a of the feed element 11 in the implant 10 and the stent. Then, the negative pressure on the hollow channel 14th is applied to the holding surface 13, whereby the implant or the stent 10 is sucked to the tube or the holding surface 13. The crimping of the implant or of the stent has the advantage that the dimensions of the entire system can be reduced in relation to the dimensions of the vessel. This will be the

Reduced stress on the vessel wall.

For the suction fixation by the delivery element 11, implants, in particular stents, are suitable in general, the suction areas, i. Have areas in which the implant wall is closed, so that in this area on the

closed surface can act a negative pressure, which fixes the implant 10 to the support surface 13. In the simplest case, the entire implant wall is closed. It is also sufficient that discrete intake areas are formed, for example, by a partial covering of the implant or the

Lattice structure of the implant is achieved. For sputtered stents, the areas between perforations may act as suction areas. Even at

braided stents or implants, it is possible to use the crossings of the wires as suction areas. The openings 15 may be aligned with the suction regions 23 such that the suction regions 23 (see FIGS. 5a, 5b) are aligned with the openings 15. It is also possible for the openings 15 to be arranged such that the implant 10 or the stent does not have to be aligned, but in each position on the holding surface 13 a closed region or an intake region 23 is located at the level of an opening 15 with this aligns.

The suction area or areas 23 correspond to the holding and / or release areas and are generally area that can be acted upon by a pressure to generate a force.

The implant 10 or the stent may be a circumferentially closed cylinder which is not flexible and can not be crimped. The inner diameter of the cylinder is slightly larger than the outer diameter of the distal end 12a of the feed element 11. During fixing, a part of the inner surface of the cylinder bears against the holding surface 13. A non-flexible implant is particularly useful when the length is limited and the vessel is relatively straight. It is also possible, an implant with a flexible wall, ie with a

Flexibility in the radial direction, which is crimped or radially deformable to use with the application system of FIG. 1, which has the advantage that the wall almost completely or at least over a larger area than a rigid implant to the support surface 13 applies , An example of an implant 10 with a flexible wall is shown in FIGS. 3a, 3b. The implant also has a cylindrical shape here. Through the longitudinal slot 29, the lumen or the

Inner diameter of the implant variable. In the expanded state that has

Implant, as shown in Fig. 3b, in cross section a C-shape. As a result, a particularly simple crimping of the implant is possible without complex

Structural geometries are required.

As shown in FIGS. 5a, 5b, structuring in the form of perforations 24 can be provided in the implant wall, which improves the flexible behavior of the implant (see FIG. 5b). The implant according to FIGS. 5a, 5b

(unwound state) has due to the perforation 24 has a structure that allows extension of the implant (Fig. 5b). This allows the implant 10 in tortuous vessel areas at the outer radius of the curved, to the

extend tortuous vessel areas adapted implant. The perforated structure also has the advantage that the endothelialization is favored.

Examples of suitable perforation geometries are disclosed in the copending applications entitled "Medical Implant and Method of Making Such Implant" and "Medical Device", which are assigned to the Applicant and incorporated herein by reference in their entirety.

In Fig. 5a is further shown that the suction regions 23, those

enclosed areas of the implant wall, which form between the

Perforations 24 are located.

The operation of the device according to FIG. 1 or according to FIG. 2 is shown in FIGS. 3a and 3b. This mode of operation applies to all embodiments disclosed in the application in which a flexible implant 10 is used. As shown in FIG. 3 a, the negative pressure transmitted to the holding surface 13 via the hollow channel 14 and the side channels 16 holds the implant 10 or the C-shaped stent firmly. If the negative pressure is released, the implant 10 releases from the holding surface 13 and unfolds to the vessel wall 30. The release of the implant 10 from

Feed element 11 can be assisted by exerting an overpressure on the implant 10 via the hollow channel 14 and the side channels 16, which assists the unfolding of the implant 10.

It is shown in FIGS. 4a to 4c that the delivery element or, in general, the device for supplying a medical implant can not be used only for discharging the implant in the vessel. It is also possible to remove an implant or stent released in the vessel from the vessel. The device thus serves not only as a supply system but also as a return system for

Implants.

For this purpose, the holding surface 13 is brought to the implant inner wall (FIG. 4 a), wherein at the same time a negative pressure is applied to the openings 15. Thereafter, the feed element 11 is rotated, as illustrated by the arrow of FIG. 4b and indeed into the implant. As a result, an increasing part of the

Inner surface of the implant in abutment with the support surface 13, which sucks through the openings 15, the implant wall, as far as they cover the openings 15, and holds. In Fig. 4c is shown that the entire inner surface of the implant rests against the support surface 13 and is sucked by this. The outer diameter of the implant 10 is thus reduced so far that the implant 10 can be removed from the vessel. This possibility of use also applies to everyone

Embodiments in this application.

Fig. 6a, 6b show further embodiments of the device according to the invention. In these embodiments, a tip 17 at the distal end 12a of the

Feed element 11 is arranged. Concretely, the tip 17 is provided on the end face 26 of the distal end 12a and extends in the extension of the holding surface 13 in the distal direction. In general, the tip can be shaped like the tip of a known puncture needle. The tip 17 has the function of pushing a thrombus against the vessel wall before the holding surface 13 with the implant 10 advances further and the implant is released in the target vessel (FIG. 6 b). The tip 17 has a first side 18a and a second side 18b in cross-section. The first side 18a is inclined with respect to a longitudinal axis of the feed element 11. The second side 18b of the tip 17 extends parallel to the longitudinal axis of the Feed element 11. This is a particularly favorable profile of the tip

which causes the tip 17 to be moved between the thrombus 31 and the vessel wall 30 without damaging the thrombus (Figure 6a). It is also possible, the two sides 18a, 18b relative to the longitudinal axis of the

Supply element to arrange differently inclined.

In Fig. 7, another embodiment is shown in which the hollow channel 14 extends completely through the proximal end 12a and has an opening 19 which connects the hollow channel 14 with the environment. The opening 19 can be formed either in the end face 26 or, if the tip 17 is arranged on the end face 26, in the first, inclined side 18 a of the tip 17. By the continuous hollow channel 14 of FIG. 7, for example

Medicaments are administered as soon as the implant 10 or the stent is in the vessel and the hollow channel 14 is no longer needed as a vacuum channel or suction channel.

For example, thrombusolubilizing drugs can be administered through the hollow channel 14. Another application of the hollow channel 14 is to use this for sucking the thrombus. This can be a try

be made to remove the thrombus in this way from the vessel before the implant 10 or the stent is discharged. For this purpose, the hollow channel 14 is connected either to a drug delivery device or to the suction device, which is required anyway for fixing the implant 10. In the embodiment according to FIG. 7, it is also possible first to introduce the feed element 11 without an implant, the primary aim being to suck in the thrombus, fix it to the tip 17 and thus remove it from the vessel. At this point, it is once again pointed out that the delivery element 11 or the associated device is disclosed and claimed both with the implant 10 (in the form of an arrangement) and without the implant 10.

Due to the negative pressure, it may happen that the hollow channel 14 sucks blood, with only very small blood flows resulting from the very narrow capillary openings 15, which pass into the hollow channel 14. This also applies to the further opening 19 for the drug delivery. It is possible to provide the tip 17 with a valve (not shown), so that the blood flow takes place only in the direction of the tip, ie away from the user, and not in the direction towards the user. The embodiment according to FIG. 8 has a telescopic construction, which has the advantage that the sliding of the system or the movement in the distal direction during placement of the implant is improved, in particular in regions outside the target vessel. The delivery element 11 can be very thin and flexible, which preserves the advantages with regard to the implantation of stents in very small vessels. The telescopic insert is for the endovascular

Treatment is provided, in which a critical vessel is reached from a peripheral vessel. For this purpose, as shown in Fig. 8, it is provided that the feed element 11 and a proximally arranged from the feed element

tubular further feeding element 20a are telescopically slidable. As shown in Fig. 8a, the conical transition region 27 forms a stop for the tube-like supply element 20a, whose distal end

is formed complementary to the stop or to the transition region 27. Specifically, the inner wall of the distal end of the tube-like tapers

Feed element 20a in the distal direction. The hose-like feed element 20a is guided in a further tube-like feed element 20b, which in turn can be mounted telescopically. Alternatively, the first tubular

Feed element 20a may be guided in the line 21 of a catheter.

The feed element 11 with the holding surface 13 forms the distal outermost element of the application system according to FIG. 8. The various elements 11, 20a, 20b are relatively movable relative to one another. It is possible that all elements 11, 20a, 20b reach the user, so that the user the proximal end of all

Can see and operate elements 11, 20a, 20b.

It is also possible that the user sees only part of the feed elements 11, 20a, 20b and can operate directly. Removal of the pushers will increase the total suction lumen and increase suction and / or reduce the pressure necessary to deliver medication. Alternatively, the user can move the feed elements 11, 20a, 20b, in particular the feed element 11 with the holding surface 13 by a pusher in the distal direction. The pushers can move the inner elements, such as the feed element 11 with the holding surface 13 and the tube and then decoupled. It is also possible that the pusher (s) enable a retract function. FIG. 9 shows the interventional use of the application system with the telescopic structure according to FIG. 8. In this case, the entire catheter or line 21 is introduced through the femoral artery. The pushability of the system is ensured in the large vessels. Due to the telescopic structure of the supply system, this is able to penetrate into the branched small vessels (Fig. 9). It is also possible that the individual catheters or

Feed elements are preformed so that they are in the range of the corresponding

Bifurcations of the anatomy follow. The output of each catheter or supply element from the next larger catheter or supply element can also be made laterally, for example by laterally aligned recesses in the catheters or

Supply elements.

The following dimensions of the tube or the feeding element 11 are suitable for the treatment of small vessels with a diameter between 500 pm and 1 mm:

- Outer diameter: <1.2 mm, in particular <1 mm, in particular <0.8 mm, in particular <0.6 mm, in particular <0.4 mm, in particular <0.3 mm.

Wall thickness: <200 pm, in particular <150 pm, in particular <100 pm,

in particular <50 pm, in particular <40 pm, in particular <30 pm, in particular <20 pm, in particular <10 pm.

By outer diameter is meant the diameter on which the stent sits, i. the diameter of the distal end 12a in the region of the holding surface 13th

For the treatment of vessels with a diameter of less than 500 pm, the following dimensions of the feed element 11 in the region of the holding surface 13 have proven to be expedient:

- Outer diameter: <0.8 mm, in particular <0.6 mm, in particular <0.4 mm, in particular <0.2 mm, in particular <0.15 mm, in particular <0.12 mm, in particular <0.10 mm. Wall thickness: <150 μm, in particular <100 μm, in particular <50 μm, in particular <40 μm, in particular <30 μm, in particular <20 μm, in particular <10 μm, in particular <5 μm.

The above-mentioned outer diameters can be applied to a region with a length of <10 mm, in particular <8 mm, in particular <6 mm, in particular less than 4 mm, in particular <3 mm, in particular <2 mm in the region of the distal end 12a, ie where The stent or the implant is fixed, are limited.

The following values are possible for the dimensions of the stent:

- Stents with diameter between 200 μητι and 1 mm. The stent has a wall thickness which is less than 5/100, in particular less than 2/100, in particular less than 1/100 of the diameter.

Examples:

- Stent with a diameter of 1 mm, wall less than 50 μιη, in particular less than 10 μηη

- Stent with diameter 500 μηη, wall less than 25 μιη, in particular

less than 5 μητι

- Stent with a diameter smaller than 200 μπι. The stent has a wall thickness which is less than 10/100, in particular less than 8/100, in particular less than 5/100, in particular less than 3/100 of the diameter.

Examples:

- Stent with diameter 200 μηη, wall less than 20 μιτι, in particular

less than 6 μιη

- Stent with diameter 100 μιτι, wall less than 10 μητι, in particular

less than 3 μητι

- Stent with diameter 500 μπι, wall less than 25 μιτι, in particular

less than 5 μιη

It is also possible to use very thin-walled, sputtered stents or

To use implants. The thickness of the wall of such stents is <15 μm, in particular <12 μm, in particular <10 μm, in particular <8 μm.

in particular <6 μητι, in particular <5 μητι, in particular <4 μηι, in particular <3 μιη. The diameter of the feed element 11 in the amount of the holding means or the

Holding surface 13 is <1 mm, in particular <500 pm, in particular <200 μιη, in particular <150 μητι, in particular <120 μιη, in particular <100 μηι,

in particular <80 .mu.m, in particular <60 .mu.m.

The implant can be made by a sputtering technique and photolithographic etching

be prepared both in cylindrical and in planar form, which is then rolled cylindrically. The advantage of this is that the structure is very flat and can be sucked in very well. It is also possible to braid the implant, in particular the stent, wherein the wires have a diameter of <10 μιτι, in particular <5 μητι.

Materials for the tube (delivery element 11) may be: glass, plastic, ceramic and superelastic metal such as Nitinol. For example, the tube can be cylindrically sputtered using a very thin copper wire as the carrier. The preparation of the delivery element can be done as in the stent. The advantage of glass, ceramics and NiTinol is that the thin tubes will not plastically deform even with large deformations or forces, which could affect the accuracy of the treatment. Additional materials may include radiopaque materials such as tungsten, platinum-iridium, iridium or iridium alloys. Also stainless steel is possible.

The suction function can be fulfilled as follows: A vacuum chamber can be connected to the proximal end of the feed element. It can be in the form of a soft pipette, possibly filled with a liquid that is pressed together before the implant is placed on the holding surface of the tube. The operation can be carried out before use so that the negative pressure does not exist in the packaging and decreases due to leaks in storage time. The overpressure chamber can be constructed accordingly.

Furthermore, in the context of the application both the use of the device for supplying the medical implant for the treatment of eye diseases as also discloses a method for the treatment of ocular diseases with the device for delivering the medical implant according to this application.

LIST OF REFERENCE NUMBERS

10 implant

11 feed element

12a end / first end

12b end / second end

13 holding surface

14 hollow channel

15 openings

16 side channels

17 tip

18a, 18b sides of the top

19 opening

20a first hose-like feed element

20b second hose-like feed element

21 line

22 wall

23 intake area

24 perforation

25 entrance opening

26 face

27 transition area

28 introducer sheath

29 longitudinal slot

30 vessel wall

31 thrombus

Claims

claims

1. Device for supplying a medical implant (10) in a

A body cavity with a supply element (11), wherein at one end (12a) of the feed element (11) a holding surface (13) for the implant (10) is formed, the end (12a) with the holding surface (13) can be placed in the body cavity and the holding surface (13) is adapted such that the implant (10) is detachable from the holding surface (13) for release in the body cavity, that is to say that

the holding surface (13) is formed on an outer circumference of the feed element (11) and the feed element (11) has at least one hollow channel (14) which extends into the region of the holding surface (13) and with at least one, in particular with a plurality of openings ( 15) which are formed in the holding surface (13), wherein the hollow channel (14) is connected to a suction device and / or a pressure device or connectable and a suction line and / or a pressure line forms such that the implant (10) can be acted upon in use with a holding pressure for fixing the implant to the feed element (11) and / or with a release pressure for releasing the implant.

2. Apparatus according to claim 1

d a d u rc h e s n e s n e s n e ch n eti ch n et that ch

Side channels (16), which are arranged radially, the hollow channel (14) and the openings (15) connect.

3. Device according to claim 1 or 2

d a d u rc h e ke n ze ze ch n et that

the feed element (11) has a tip (17) which is arranged by the user distally of the holding surface (13) and is designed such that in

Use a calculus, especially a thrombus, through the tip (17)

*

pressed against the vessel wall and / or a vessel or tissue is puncturable.

4. Apparatus according to claim 3

d a d u rc h e s n e s n e s n e ch n eti ch n et that ch

the tip (17) in longitudinal section two, with respect to the longitudinal axis of the Feed element (11), differently inclined sides, or one for

Longitudinal axis of the feed element (11) parallel side (18b) and an oblique side (18a) has or is conical.

5. Device according to at least one of claims 1 to 4

d a d u r c h e n c i n e s that

the hollow channel (14) is connected or connectable to a supply device for medicaments and / or liquids such that the hollow channel (14) forms both a suction and / or pressure line and a medicament supply and / or fluid supply.

6. Apparatus according to claim 5

d a d u rc h e n c e n c e n e s that

the hollow channel (14) has an outlet opening for the medicament supply and / or liquid supply, which is provided at the end (12a, 12b) of the feed element (11).

7. Device according to at least one of claims 1 to 6

d a d u r c h e n c i n e s that

the hollow channel (14) has at least one valve, which is disposed downstream of the user (s) distally downstream or proximally and closes the hollow channel (14) during suction or pressure operation.

8. Device according to at least one of claims 1 to 7

d a d u rc h e n c e n c e n e s that

the hollow channel (14) has at least one further opening (19) which at the end (12a) of the feed element (11) for sucking and holding a

Concrements, in particular a thrombus is formed.

9. Device according to at least one of claims 1 to 8

d a d u rc h e n c i n e s that

the supply element (11) with the holding surface (13) and at least one first hose-like supply element (20a) are telescopically arranged one inside the other.

10. Apparatus according to claim 9

In this case, that is

the first feed element (20a) and at least one second hose-like feed element (20b) are arranged telescopically in one another.

11. Apparatus according to claim 9 or 10

It is not possible that

the supply element (11) with the holding surface (13) is formed in its length so that a user from the proximal end (12b) of the supply element (11) in the fully extended state by the user is operable.

12. The device according to at least one of claims 1 to 10

It is not possible that

the supply element (11) with the holding surface (13) in a conduit (21), in particular in a catheter, is arranged relatively movable, wherein the in the feed element (11) formed hollow channel (14) through the conduit (21) with the suction device and / or the printing device and / or the

Drug supply and / or fluid supply is connected or connectable.

13. An arrangement comprising a device according to one of the preceding claims and a medical implant (10) in the region of

Holding surface (13) on the supply element (11) is fixable, wherein the implant (10) has a wall (22) with at least one holding and / or release area (23) which in use at least one opening (15) in the holding surface (23). 13) and covered with a holding force and / or a release force

can be acted upon, which is generated in use by the holding pressure or the release pressure.

14. Arrangement according to claim 13

It is important to note that

the wall (22) comprises a rotationally symmetrical, in particular a cylindrical wall, which is rigid or flexible.

15. Arrangement according to claim 13 or 14

dadu rch ke nzei ch net, that the wall (22) is structured by a perforation (24), the ratio between the material surface and the entire wall surface being more than 20%, in particular more than 30%, in particular more than 40%, in particular more than 50%, in particular more than 60% , in particular more than 70%, in particular more than 80%, in particular more than 90%.