AT15630U1 - Device for using multiple intraluminal surgical clips - Google Patents

Abstract

A vascular prosthesis delivery system comprising: an elongate body (11A, 132) having a proximal end (152), a distal end (156) and a plurality of delivery platforms (160) disposed adjacent the distal end; a sheath (13, 136) having a proximal end (192), a distal end (198) and an elongate sheath body (200) extending therebetween, the sheath being movable relative to the elongate body (132) a first position, wherein the distal end of the sheath is located distal to a distal distal delivery platform, to a second position, wherein the distal end of the sheath is proximal to at least one delivery platform; a plurality of self-expanding vascular prostheses (10, 10 ', 10 ", 140), each vascular prosthesis having a plurality of struts (26, 27, 28, 29) forming a plurality of cells (16) and a corresponding one Delivery platform (160) is arranged, wherein the system is configured to place at least two vascular prostheses separately, one after the other, at a treatment area at spaced locations, so that a gap between the distal end of a proximal vascular prosthesis and the proximal end of a distal vascular prosthesis, each self-expanding vascular prosthesis in the plurality of self-expanding vascular prostheses having an ear and a radiopaque marker (22) positioned in the ear.

Description

description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a partial continuation of U.S. Patent Application Serial No. 13/153257, filed June 3, 2011, and a partial continuation of the U.S. Patent Application. Serial number 13/118388 filed on May 28, 2011, both of which are in part continuations of the US patent application. Serial No. 12 / 790,819, filed May 29, 2010, which is a partial continuation of the U.S. patent application. Serial No. 12 / 483,193, filed June 11, 2009, which is a partial continuation of the U.S. patent application. Serial No. 11 / 955,331, filed December 12, 2007, is now U.S. Pat. 7,896,911. This application further claims the benefit of priority over US Provisional Patent Application No. 61 / 362,650, filed on Jul. 8, 2010. US patent application Ser. No. 13 / 118,388 claims the benefit of priority over US Provisional Patent Application No. 61 / 349,836 filed on May 28, 2010.

BACKGROUND OF THE INVENTION

Field of the Invention The present invention relates to the treatment of atherosclerotic occlusive disease by intravascular procedures in which plaque deposited on the blood vessel walls is pushed aside and held so as to reopen the blood flow.

Artherosclerotic occlusive disease is the primary cause of stroke, heart attack, amputation and death in the US and in the industrialized world. Artherosclerotic plaque forms a hard layer along the wall of an artery, and consists of calcium, cholesterol, and compacted thrombus and cell debris. As the atherosclerotic disease progresses, the blood flow that should pass through a particular blood vessel is reduced or even prevented by the occlusion process. One of the most commonly used procedures for the treatment of clinically significant atherosclerotic plaque is balloon angioplasty.

[0004] Balloon angioplasty is a recognized method of opening blocked or stenosed blood vessels in each vascular bed of the body. Balloon angioplasty is performed with a balloon angioplasty catheter. The balloon angioplasty catheter consists of a cigar-shaped cylindrical balloon attached to a catheter. The balloon angioplasty catheter is inserted into the artery from a remote access site created either percutaneously or by open exposure of the artery. The catheter is advanced on the inside of the blood vessel via a wire which guides the catheter on its way. The portion of the attached balloon catheter is placed at the site of the atherosclerotic plaque that requires treatment. The balloon is inflated to a size that matches the original diameter of the artery before the occlusion disease develops. When the balloon is inflated, the plaque is broken. Cracking levels form within the plaque, allowing the plaque to expand in diameter with the expanding balloon. Often, one segment of the plaque is more resistant to dilation than the remaining plaque. If this is the case, higher pressure pumped into the balloon will result in full dilatation of the balloon to the intended size. The balloon is deflated and removed, and the arterial segment is re-examined. In the process of balloon angioplasty there is an uncontrolled plaque disruption. The lumen of the blood vessel at the treatment site is usually slightly larger, but not always and not reliable.

Some of the fracture planes generated in balloon angioplasty by the fracture of the plaque can form a dissection. A dissection occurs when some of the plaque is lifted off the artery, does not fully adhere to the artery, and may be mobile or loose. The dissection-interrupted plaque protrudes and enters the bloodstream. Placing the plaque completely in the direction of blood flow may interfere with blood flow or cause an acute occlusion of the blood vessel. It has been demonstrated that dissection after balloon angioplasty must be treated to prevent occlusion and remedy residual stenosis. It has also been shown that under certain circumstances it is better to use a metal support structure, such as a stent, to keep the artery open after angioplasty and to force the divided material back against the wall of the blood vessel to create adequate lumen for blood flow.

The clinical treatment of a dissection after balloon angioplasty is currently done essentially by stents. As shown in FIG. 1, a stent 3 is a tube having a diameter that is sized to the artery 7. A stent is inserted into the artery at the dissection site to force the dissection flap against the inner wall of the blood vessel. Stents are usually made of metal alloys. They have varying levels of flexibility and visibility, as well as different placement techniques. Stents are inserted into each vascular bed in the body. The development of stents has significantly changed the approach to minimally invasive treatment of vascular disease, making it safer and, in many cases, more durable. The occurrence of acute occlusion after balloon angioplasty has been significantly reduced by stents.

However, stents also have significant disadvantages and much research and development is being done to address these issues. Stents introduce a recurrent constriction of the treated blood vessel (recurrent stenosis). The recurrent stenosis is the "archilles heel" of the stenting. Depending on the location and size of the artery, intimal hyperplastic tissue ingrowth may occur from the vessel wall between the ridges or through the openings in the stent and result in failure of the vascular reconstruction due to stenosis or occlusion of the stent. This can be done anytime after inserting a stent. In many cases, the stent itself appears to elicit a local reaction of the vessel wall causing stenosis, even in the segment of the stent that was placed over arterial segments that were not particularly narrowed or diseased upon insertion of the original stent. This reaction of the blood vessel to the presence of the stent is likely due to the scaffolding effect of the stent. This reaction of a recurrent stenosis or ingrowth into the blood vessel occurs in response to the stent. This activity shows that the extensive use of metal and the vascular coverage in the artery, which occurs during the insertion of stents, contribute to constriction. Recurrent stenosis is a problem because it results in stent failure and there is no effective treatment for it. Among the existing treatment methods that have been used against this problem include u. a. repeated angioplasty, angioplasty with a cutting balloon, cryoplasty, atherectomy and even repeated stenting. None of these methods can demonstrate a high degree of long-term success.

Stents can also break due to material stress. A stent fracture may result from chronic material stress associated with the development of a recurrent stenosis at the stent fracture site. This is a relatively new finding and may require special stent designs for each application in each vascular bed. The structural integrity of stents remains a current issue in their use. Particularly mobile arteries, such as the arteries of the lower extremities and the carotid arteries, are particularly problematic. The integrity of the entire stent is tested each time the vessel is bent or compressed anywhere along the stented segment. One reason why stent fractures may occur is that a longer segment of the artery was treated as necessary. The scaffolding effect of the stent impairs the general mechanical behavior of the artery, making the artery less flexible. The available luting materials have limited bending cycles and are susceptible to repeated and frequent bends.

Stents are used in many arterial segments, even if it is not required for these. This aggravates the disadvantages of stents. There are mutliple reasons for this. In many cases, more than one stent must be used, often several are required. Much of the stent length is often placed over arterial segments that do not require a stent. They just border on a dissection or disease area. There are no stents adapted to the exact length of the lesion. When trying to deploy multiple stents into those segments where stent placement is most needed, the cost is prohibitive since each stent is associated with deployment and material costs. The time required for this also adds to the costs and risks of the procedure. The longer the artery, where a stent is to be used, which is not required, the stiffer the artery and the greater the resulting scaffolding effect. This can also help to trigger the arterial response in the stent, causing a recurrent stenosis.

SUMMARY OF THE INVENTION

There is a continuing need for the development of new and improved devices for assisting the treatment of vascular diseases, such as: a. atherosclerotic occlusive disease, for the purposes described above.

In one embodiment, a system is provided for providing a vascular prosthesis that includes an elongated body, a wrap, and a plurality of intravascular staples. The elongated body has a proximal end, a distal end and a plurality of delivery platforms disposed adjacent the distal end. Each of these delivery platforms includes a recess extending distally of an annular marker band. The sheath has a proximal end, a distal end and an elongated body extending therebetween. The sheath may be moved from a first position to a second position in relation to the elongate body. In the first position, the distal end of the sheath is located distally of a distal-most distal delivery platform. In the second position, the distal end of the sheath is disposed proximally of at least one delivery platform. Each of the intravascular staples is disposed around a corresponding delivery platform.

In certain embodiments, the system is configured to place at least two staples in a treatment zone at spaced apart locations. In such placement, a minimal gap may be provided in the treatment area between a distal end of a proximal staple and a proximal end of a distal staple. This minimal gap can be advantageously provided without having to move the elongate body or delivery platforms.

The gap advantageously minimizes the likelihood that two staples will get caught in the vessel, or that other discomfort will occur due to too close proximity.

A minimum distance between adjacent distal surfaces of each annular marker band is provided to minimize movement of the elongated body so as to provide a minimum gap between the provided staples. For example, in certain embodiments, there is substantially no change in the axial distances of the staples provided as compared to the distances of the staples on the delivery platforms. As a result, the minimum clearances of the distal surfaces can help prevent over-provisioning of the adjacent staples.

One approach to maintaining a minimum gap, such as minimizing the change in spacing between the un-provided staples and the provided staples, is to provide a support for immobilizing the proximal end of the delivery system such that movement of the system in the Serving is focused and only a slight, if any, motion is allowed in the elongated body.

Another approach involves providing a stabilizing device disposed on an outer surface of the delivery system so as to minimize at least one of the axial or radial displacements of at least one of the delivery platforms.

In another embodiment, a method of placing an intravascular staple is provided. A catheter system is provided which includes an elongate body including a plurality of spaced delivery platforms disposed adjacent a distal portion of the elongated body. The position of at least one of the delivery platforms is indicated by a marker band. There is a plaque staple on each platform. The distal portion of the elongate body is advanced through a patient's vasculature until the marker band is proximal or distal to a dissected plaque treatment area. The marker band is visualized to confirm the position of at least one of the delivery platforms in relation to the dissected plaque. The outer cover is retracted while maintaining the position of the elongate body, and thereafter at least two of the staples are provided to place the staples in a predetermined position and at predetermined intervals.

In various methods, a stabilizer may be provided prior to stapling deployment. The elongate body may be stabilized by the actuation of a stabilizer disposed at the distal end of the catheter system or by the coupling of the elongate body with a proximal end support so as to prevent unwanted displacement in the vessel at the distal end of the elongate body to minimize the delivery platforms.

In another embodiment, a system for providing a vascular prosthesis is provided that includes an elongate body, an elongate package, and a wrapper. Wherein the elongated body includes a distal end, a proximal end and a piston disposed adjacent to the distal end. The elongated package has a variety of intravascular staples coupled thereto. The staples are provided along the length of the elongated package. The sheath has a proximal end and a distal end, the sheath being movable relative to the elongate body from a first position, in which the distal end of the sheath is located distal to at least a portion of the elongate packet, to a second position, in which the distal end of the sheath is disposed proximal to the elongate packet. The elongated package is configured to maintain a minimum distance between the adjacent staples during deployment and to permit expansion and separation from the elongate body. The elongate package is configured to release the staples so that they can expand toward a vessel after deployment.

An endoluminal staple may include proximal and distal peripheral portions. The proximal peripheral portion may be provided at a proximal end of the endoluminal staple. The distal peripheral portion may be provided at a distal end of the endoluminal staple. In some embodiments, the distal peripheral portion is the most distal aspect of the endoluminal staple, and the proximal peripheral portion is the proximal-most aspect of the endoluminal staple. The proximal and distal peripheral parts may be connected by bridge parts. The bridge members may include one or more anchors configured to be fixed in the plaque and / or blood vessel wall. The anchors may have an increased material thickness, as opposed to the remainder of the staple, thereby increasing the radiopacity of the anchor and eliminating the need for a separate indicia marking.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] These and other features, aspects, and advantages are described below with reference to drawings of preferred embodiments which are given for illustration but are not intended to limit the present invention in any way.

FIG. Figure 1 illustrates the use of a stent deployed after angioplasty, as is conventionally practiced conventionally.

FIG. Figure 2 illustrates the use of plaque staples used after an endoluminal procedure and demonstrates their advantages over the prior art.

FIG. FIG. 3A shows an embodiment of a plaque staple in the end view; FIG. 3B shows this in side view, FIG. FIG. 3C shows the plaque staple in perspective view; and FIG. 3D shows part of the plaque staple in a flat or rolled out view.

FIG. 4 is a schematic representation of a distal portion of a delivery device that has advanced to a treatment site that has been expanded in the blood vessel.

FIG. FIG. 4A illustrates the proximal end of one embodiment of FIG

Providing device.

FIG. 4B is a plan view of the distal part of the embodiment shown in FIG. 4 shown

Providing device.

FIG. 4C is a cross-sectional view of the distal portion of FIG. 4B, in which a plurality of stapling devices prepared for implantation are shown.

FIG. 4D shows the provision of two stapling devices after the return of a wrapping.

FIGS. 5A and 5B show another embodiment of a plaque staple, each in a collapsed state and in an expanded state.

FIG. 5C shows a detail view of a portion of the plaque staple of FIG. 5A-B.

FIG. Fig. 5C1 shows a variation of the embodiment of Figs. 5A-5C with a larger anchorage.

FIG. 5D shows a variation of the embodiment of FIGS. 5A-5C with an anchor disposed on a centerline of the staple.

FIG. Fig. 5E shows a variation with ridges that taper from wider at the lateral edge of a staple to narrower at the middle of the ridge, and / or narrower at the middle of a ridge to wider adjacent to a medial position of the staple.

FIG. 6A is a graph in which the expansion forces of a plaque

Staple compared with those of a stent.

FIG. Figure 6B illustrates the use of multiple plaque staples spaced across the length of a treatment site as compared to that of a typical stent.

FIG. Figure 7A shows another embodiment of a plaque staple in the fully compressed state.

FIG. 7D shows the plaque staple in a fully expanded

State, and FIGS. Figures 7B and 7C show the plaque staple in expansion states between the fully compressed and fully expanded states.

FIG. 8 is a schematic representation of the focal elevation element of a plaque staple of FIGS. 7A-D.

FIG. Figure 9 is a schematic diagram illustrating the variables in calculating the raised staple surface through the use of focal elevation elements in a plaque stapling device.

FIG. Figure 10 illustrates the use of a plaque staple with focal elevation elements for holding a plaque against a blood vessel wall.

FIGS. Figures 11 and 12 illustrate an application variant of the focal elevation elements on a plaque staple.

FIGS. Figures 13 and 14 illustrate another variant of the application of the focal

Lifting elements on a plaque staple.

FIG. Figure 15 illustrates the use of focal elevation elements to reshape arterial walls into a desired cross-sectional shape.

FIGS. Figures 16-22 illustrate variations in the shaping and positioning of focal elevation elements on the struts of a plaque staple.

FIGS. 23-29 illustrate a method of providing a plaque stapling staple in a blood vessel.

FIGS. Figures 30A-B show a focal elevation element fixed to plaque.

FIGS. Figures 31A-B show anchorages fixed to plaque.

FIG. Figures 32A-32B depict, respectively, the proximal and distal views of a system for providing a vascular prosthesis with a distal end of a sheath of the system distal to one or more plaque staples.

FIG. Figures 33A-33B show, respectively, the proximal and distal views of the system of Figures 32A-32B with the distal end of the sheath positioned proximal to one or more plaque staples.

FIG. Figure 34 shows a system for providing a vascular prosthesis.

FIG. Fig. 35 shows an enclosure that may be used to constrain and provide one or more staples.

FIGS. FIGS. 36-36A illustrate an embodiment of an elongate body that may have one or more plaque staples disposed within the sheath of FIG. 35.

FIGS. 37A-37B illustrate a variation of the delivery system in which an actively actuated member is provided for anchoring the system near the treatment area.

FIG. Fig. 38 illustrates a variation of the delivery system in which one

Linkage for active actuation of a part, which is positioned near the treatment area, is provided.

FIGS. Figures 39-40 illustrate delivery systems with passively expanding parts for stabilizing a distal delivery area.

FIG. 41 illustrates a delivery system with a friction isolator

Enclosure for stabilizing a distal staging area.

FIG. FIG. 42 illustrates a delivery system that provides a deliverable

Package for maintaining spacing between adjacent prostheses.

FIG. Fig. 43 illustrates an embodiment of a deployment package that has been adapted to maintain spacing between adjacent prostheses.

FIG. FIG. 44 illustrates a delivery system that provides a deliverable

Includes package for maintaining spacing between adjacent prostheses, with a restraining element disposed in the staples.

FIG. Figure 45 illustrates a balloon useful for providing plaque

Staple is optimized to bring a plaque-driving rotary motion in a plaque anchorage.

FIG. Figure 45A shows a balloon for providing multiple staples.

FIG. Figure 46-48D illustrates a portion of a delivery system that may be used with any of the delivery systems disclosed herein.

FIG. 49 shows a shuttle providing device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The disclosed subject matter of this application relates to the improvement of a plaque stapling device or a stapling device. The plaque stapler may be used for the treatment of atherosclerotic occlusive disease. The plaque staple can be used to hold loose plaque pressed against a blood vessel wall. The plaque staple may include an annular member configured to exert an expansion force on the loose plaque.

I. OVERVIEW OF ENDOLUMINAL TREATMENT WITH STAPLES

FIG. Figure 2 shows an embodiment of a plaque stapler 5 which incorporates a thin annular band or ring of durable, flexible material. The stapling device may be inserted into a blood vessel in a compressed state and installed in an expanded state against the blood vessel wall at one or two specific loose plaque sites using a catheter delivery mechanism. The plaque staple 5 may be provided after or as part of an angioplasty operation. The plaque staple 5 is adapted to exert an expansion force on the plaque in blood vessel 7 so as to push and hold the plaque against the blood vessel walls. The stapler can be expanded radially outwardly under spring action or other expansion force. The fully expanded diameter of the staple 5 is preferably larger than the transverse size of the vessel to be treated. As noted below, the staple 5 can be advantageously provided in a surprisingly large blood vessel size range.

The plaque staple 5 may include a plurality of plaque anchors 9 on its outer annular periphery. The plaque anchors 9 can be in the

Integrate plaque into, or at least in physical contact with, the plaque by expanding it against the plaque. In certain embodiments, the plaque anchors 9 are adapted to lift adjacent portions of the staple 5 in relation to the wall of the vessel. At least in this sense, the anchors 9 may have some of the benefits of focal enhancement elements discussed in more detail below in SECTION III. The anchors 9 exert a holding force on the plaque while minimizing the size of the material surface area that is in contact with the plaque or blood vessel wall. As another feature, the plaque staple 5 may extend only a small portion in the axial direction of the vessel wall to minimize the amount of foreign structure placed in the blood vessel. For example, each plaque staple 5 may have an axial length L that is only a small fraction of the axial length of a typical stent.

The plaque stapling devices 10 of the present application are provided as a minimally invasive approach for attaching loose or dissected atherosclerotic plaque to the wall of the artery, as shown in FIG. 2 shown. The plaque staple must be used to treat either de novo atherosclerotic lesions or inadequate balloon angioplasty results. The plaque staple is designed to maintain an adequate lumen in a treated artery without the inherent disadvantages of vascular stents. The device may also be used to deliver medications, fluids or other "eluting" treatment agents into the atherosclerotic plaque or wall of the blood vessel or into the bloodstream.

One or more plaque staples 5 may be precisely provided in positions along the length of a plaque accumulation site where certain holding forces are needed to stabilize the site and / or to keep portions of the plaque out of the blood stream.

FIG. 2 shows that in a variety of plaque staple treatments, a plurality of plaque staples 5 may be provided to treat sites axially spaced along the vessel 7. In this way, the targeted treatments can be provided to hold loose plaque on a vessel wall without causing an excessive scaffolding effect, as outlined below. The plaque staple 5 and installation method may be designed in a number of ways that share a common methodology of utilizing the outward force of a spring-like annular band to allow the staple to be compressed, collapsed, or threaded to provide volume assumes a smaller diameter so that it can be moved on a sheath or a catheter into the appropriate position in the blood vessel, and then released into an expanded state within the blood vessel, unfolded or turned back.

The plaque stapler may be placed in the blood vessel by an endovascular introducer. SECTION IV below describes a variety of delivery methodologies and devices that can be used to provide plaque staples. The delivery device for the various embodiments may be the same or may be different with features specifically designed to provide the particular staple. The plaque staple and installation method may be designed in a number of ways that share a common methodology of utilizing an expansive force of the delivery mechanism (such as a balloon expansion) and / or the expansive force of a compressible annular band to allow the staple to position itself in the blood vessel, and then released into an expanded state within the blood vessel, unfolded or turned back.

II. FURTHER EMBODIMENTS OF ENDOLUMINARY STAPLES

[0076] Variations of the plaque staple 5 may have a net-like configuration and be arranged with one or more peripheral parts formed with discrete struts, as in open and closed cell constructions, among other designs. A. Plaque Staple with Metal Tissue Construction One embodiment of a plaque staple 10 in the form of a metal mesh structure is shown in FIGS. 3A-D shown. The plaque staple 10 is shown as having a closed cell structure with an annular band 10a made of interlaced tissue and radially outwardly extending protrusions 10b. The plaque staple may be laser cut or etched from a metal tube shape, or made from a thin metal wire that is bent, and woven into the desired mesh shape shown in FIGS. 3C-D, welded, brazed, bent and / or linked together. The boards 10b may protrude from the annular band 10a. The boards 10b may be on the outer surface of the staple and may contact and / or be integral with the wall of a blood vessel.

The annular band of the plaque staple 10 may have a dimension in the axial direction of the vessel walls (sometimes referred to herein as a length) that is about equal to or smaller than its expanded diameter so as to allow for placement of a foreign framework structure in the blood vessel minimize. Extended diameter means final diameter with unrestricted expansion. One or more staples may only be applied in positions along the length of a plaque accumulation site where certain holding forces are needed to stabilize the site and / or to keep portions of the plaque out of the blood stream.

The mesh pattern may be designed so that the plaque staple 10 can be compressed radially inwardly to a volume smaller in size. This allows the plaque staple 10 to be loaded onto or into a catheter delivery device for insertion into the blood vessel. The staple 10 may, for example, have a general annular shape with bends, such as inner V-bends, through which it may be folded in a zigzag pattern into a smaller volume compressed shape so as to be loaded into a delivery catheter, such as a delivery tube to be able to.

In the desired position in the blood vessel, the compressed plaque staple 10 is released from the delivery catheter. The net in combination with an annular shape may allow the plaque staple 10 to spring back into its expanded form. Alternatively, the staple 10 may be expanded by another device, such as a balloon. FIG. FIG. 3C shows the plaque staple 10 at rest in its fully expanded state, and FIG. 3D shows a detail of a section of the metal net.

FIGS. 4-4D show that one or more plaque staples 10 may be placed by a delivery device 11 with an outer sheath 13 at the treatment site in the vasculature of a patient and subsequently expanded. Improvements to the provisioning apparatus 11 will be explained below in SECTION IV. The staple 10 may be expanded in any suitable manner, such as the self-expansion configuration or balloon expansion. In the illustrated embodiment, a plurality of self-expanding staples 10 (or variants such as staple 10 'or staple 10 ") are disposed in the enclosure 13. The delivery device 11 includes an elongate body 11A disposed at least partially within the enclosure 13 The delivery device 11 also includes a dilatation structure 11B which atraumatically removes the tissue and helps guide the delivery device 11 through the vasculature 11. The body 11A can be received and advanced with a lumen 11C extending therethrough In the illustrated embodiment, the sheath 13 and the dilation structure 11B meet to provide the delivery device 11 with a smooth outer surface, for example by having the same outside diameter at the contact point 1A can be configured for a plurality of annular recesses 11D in which the staples 10, 10 'and 10 "can be arranged. The annular recesses 11D can be defined between one or more shoulder (s) 11E which prevent proximal or distal slippage of the staples along the elongate body 11A. The recesses 11D could be eliminated by providing a different structure for axially fixing the staples 10, 10 ', 10 "along the elongated body 10A.

FIGS. 4A and 4D show a proximal end of the device 11 and a method of providing the staples 10, 10 ', 10 ". In particular, the proximal end of the device 11 includes a handle 11F and an actuator 11G. The actuator 11G is coupled to a proximal end of the sheath 13 so that the proximal and distal movements of the actuator 11G cause proximal and distal movement of the sheath 13. FIG. 4A illustrates a distal positioning of the actuator 11G which corresponds to a forward positioning of the sheath 13 relative to the elongated body 11A and the recesses 11D. In this position, the recesses 11D and the staples 10, 10 ', 10 "are covered by the envelope. Movement of the actuator 11G proximally relative to the handle 11F causes the sheath 13 to move proximally, for example to the position of FIG. 4D moves. In this position, the most distal two staples 10, 10 ', 10 "are uncovered and can self-expand in the manner discussed herein.

Returning to FIGS. 3A-B, the bosses 10b on the surface of the staple 10 may function as anchors or lifting members for implementing in or pushing against the plaque. A series of anchors or lifting elements may be used to connect the annular band of the staple to the plaque mass or the blood vessel wall. The boards 10b may be made of a sufficiently rigid material to withstand a latching relationship with the blood vessel tissue and / or to penetrate or be fixed to the plaque and maintain the latching relationship therewith. The boards 10b may project at an angle of 90 degrees to the tangent of the annular band, or an acute angle may be used.

The plaque staple may be made of a material such as a corrosion resistant metal, a polymer, a composite or other durable, flexible material. A preferred material is a "shape memory" metal (such as nitinol). In some embodiments, a staple may have an axial length of about 0.1 to 6 mm, an expanded diameter of about 1 to 10 mm, and an anchoring height of 0.01 to 5 mm. The annular band of the plaque staple generally has a length in the axial direction of the vessel walls that is approximately equal to or smaller than its diameter so as to minimize the amount of foreign structure placed in the blood vessel. The annular band may have a ratio of axial length to diameter of only 1: 100. B. Open Cell Plaque Staple FIG. 5A-5C illustrate that a plaque staple 10 'in certain embodiments may be configured with an open cell structure. The plaque staple 10 'includes one or more peripheral portions which have undulating, such as sinusoidal, configurations and which are spaced axially. The peripheral portions may be coupled together at one or more circumferentially spaced locations by axially extending portions, sometimes referred to herein as bridge portions. These embodiments are extendable over a wide range of diameters and can be arranged in a variety of different vessels as discussed below.

The plaque staple 10 'may have features similar to those described above with respect to the plaque staple 10. The plaque staple 10 'may also be cut or etched by laser from a metal tube shape, for example. Similarly, the plaque staple 10 'may be made of a material such as a corrosion resistant metal (eg, certain coated or uncoated stainless steel or cobalt chrome alloys), a polymer, a composite, or other durable, flexible material. A preferred material is a "shape memory" metal (such as nitinol).

FIGS. Figures 5A-B show the general structure of the plaque staple 10 'with an open cell arrangement. The plaque staple 10 'is shown as having two peripheral portions 12, which may be rings formed by a plurality of zigzag struts connected by bridges 14 extending between the rings 12. The rings and bridges define a column of limited cells 16 along an outer surface of the staple. The outer surface extends over an outer periphery, such as an outer circumference of the staple 10 '. The boundary of each cell 16 consists of a series of parts or struts. As illustrated, the second ring is a mirror image of the first ring, although the first and second rings may be circumferential members of various configurations. In addition, the bridges 14 may be symmetrical about a transverse plane, extending through the axial center thereof, although other configurations are possible. The rings 12 may be considered coaxial, which term is broadly defined to include two spaced apart rings, or structures having centers of rotation or mass disposed along a common axis, such as the central longitudinal axis of the staple 10 '.

Fig. 5C is a schematic, flat view of a portion of a staple 10 'which is part of the cell 16 and part of a boundary thereof. The part to the right of the center line C is in one embodiment one half of cell 16. The other half may be a mirror image as shown in Figs. 5A-B, may be an inverted mirror image or other configuration. The part of ring 12 that is part of an individual cell 16 may define a part that is repeated in a pattern along the ring. In some embodiments, the ring 12 may comprise portions that are repeated in a pattern that extends across cells, such as over 1.5 cells, 2 cells, 3 cells, etc. The pattern of the rings 12 in combination with other features of the staple 10 'can allow it to be compressible in scope. The difference between the compressed and expanded states can be seen from a comparison of the compressed view as shown in Fig. 5A and the expanded view shown in Fig. 5B.

The cells 16 of the staple 10 'may be bounded by portions of two rings 12, which may be mirror images of each other. Thus, some embodiments may be fully described by reference to only one side of staple 10 'and cell 16. The ring 12, part of which is illustrated in FIG. 5C, has a wave-shaped sinusoidal pattern. The wavy pattern may have one or more amplitudes, such as the illustrated dual amplitude configuration.

The rings 12 may have a plurality of struts or structural elements 26, 27, 28, 29. The plurality of struts can be repeated around the circumference of ring 12. The struts can have many different shapes and sizes. The struts may extend in a variety of different configurations. In some embodiments, the plurality of struts 26, 27, 28, 29 extend between inner 18, 19 and outer apices 24, 25.

In some embodiments, the outer apices 24, 25 extend axially over different distances from a central region or centerline C of the staple 10 '. Specifically, apex 24 may be considered to be a high apex in this regard and apex 25 may be considered a low apex. The inner apices 18, 19 are possibly axially aligned, for example, they are positioned at the same axial distance from the center line C. Thus, the outer apex 24 is farther from the bridge and inner apices than the outer apex 25. In some embodiments, the axial length of the staple 10 'from the top of the outer apex 24 on one side of the cell 16 to the corresponding top of the outer apex 24 measured on the other side of the cell. In other words, the first outer apex 24 extends a first axial distance from the centerline C of the staple 10 ', and the second outer apex 25 extends a second axial distance from the central region C of the staple 10', the first distance being greater is as the second distance. Each side of cell 16, as shown, has a high outer apex 24 and a low outer apex 25.

The bridge 14 may be connected to one or more of the inner apices 18, 19. The bridge 14 may connect the two rings 12 together. The bridge 14 can take many different forms and configurations. Some embodiments of staple 10 'have a proximal ring and a distal ring with the bridge interposed therebetween and connecting them. As previously mentioned, the bridge 14 may be positioned in the central area or at the centerline C of staple 10 '. In Fig. 5C, the term "proximal" refers to a location on the staple 10 'that is closer to the vascular access site than the portion labeled "distal." In the staple 10 ', however, a medial part corresponding to the center line C and lateral parts extending in both directions are also conceivable. Accordingly, the site designated as "proximal" is also a medial site, and the site referred to as a "site" is also a lateral site. All of these terms can be used herein.

As shown, the bridge 14 is connected to each ring on the inner apex 18. In some embodiments, a bridge is connected to each inner apex and forms a closed cell structure. In some embodiments, the bridge 14 is connected to every other inner apex, connected to each third inner apex, or more spaced apart than required, creating a plurality of open cell configurations. The number of bridges 14 can be chosen according to the application. For example, six or fewer bridges 14 may be used between the two rings 12 to limit neointimal hyperplasia.

One method of optimizing the plaque retention capability of the bridges 14 is to align plaque-retaining structures (such as the barbs 9, the bosses 10b, or the anchors discussed below) with a force application position or direction of the ring 12. In some embodiments, at least a portion of the bridge 14 may be aligned with one of the struts of ring 12. For example, where the bridge 14 is connected to the ring 12, whether at an inner apex or a strut, the connecting portion of the bridge may be extended therefrom in a manner that is, partially or substantially, aligned with a strut. FIG. 5C shows that the bridge 14 is connected to the inner apex 18, and that the connecting part of the bridge is substantially aligned with the strut 26. In one method, a plaque support structure of bridge 14 is disposed on a projection of a longitudinal axis LA of strut 26. As discussed below, retaining clip 10 'has a plurality of anchors 20. The axis LA intersects a portion of an anchor 20 to maximize torque action from the expanded strut 26 to the anchor 20. In the arrangement of FIG. 5C, an anchorage is disposed on an opposite side of the centerline C on the axis LA axis, and the board of a longitudinal axis LA of a mirrored strut 26 intersects the anchorage 20 of the strut on the same side of the centerline C as the strut 26 , which is shown in Fig. 5C. In another method, the board of strut 26 and its mirror image strut align with the centerline C, which is rigidly coupled to the anchors 20. The bridge 14 is also aligned with a high amplitude sinusoidal section of clip 10 '.

A number of unique design features may be incorporated into the staple 10 'for various purposes, as discussed in more detail below. The staple 10 'may include, among other features, for example, one or more anchors), markers, and focal elevation elements. As discussed above, Figure 5C shows that the plaque staple 10 'may include a plurality of anchors 20 (e.g., two). The staple 10 'may also include a position marker 22 on each bridge 14. The position markers 22 may be fluoroscopically opaque and are generally flat in an array. As used in this context, flat markers are arranged to have a planar outer surface that is tangent to a cylinder that extends through an outer surface of staple 10 'or that is concentric with the outer surface, but radially within Outside surface is arranged. The anchors 20 may equally be configured to be tangent to a cylinder extending through an outer surface of staple 10 '.

As another example, a number of unique design features can be incorporated into the staple 10 'to dynamically distribute loads within the staple 10'. These design features may enable uniform control of staple 10 'in compression, expansion, deployment, and catheter release. These design features may also individually and / or collectively handle the stresses that affect the amount of staples, along the struts and at the interface of the staple and blood vessel lumens. Better control of stress distribution within the staple has the advantage of reducing cellular reaction and staple fracture by limiting strut fatigue and associated micro-scrubbing at the staple / blood vessel interface. Micro-scrubbing causes a variety of small harmful interactions between implants and patient tissue, such as abrasion or friction that occurs at the cellular or intercellular level between the staple and the blood vessel lumen.

It is believed that a reduction in cellular response is achieved in part by a reduction in surface area contact between the staple and blood vessel lumens and in part by maximizing alignment of the contact points or structures with the natural orientation of the blood vessel cells. Thus, the staple may move with the blood vessel while reducing micro-chafing. Other devices, such as stents, contact the blood vessel cells in ways that may be harmful to one another. U. across several cells -such as transverse to several cells - may extend, thereby increasing the micro-chafing at the interface stent / blood vessel. 1. Cell Design with Column [0098] A property of the staple embodiment 10 'of Figs. 5A-C is that it comprises an open cell structure with a column held between two zigzag rings. This arrangement provides minimal (if any) scaffolding effects to a vessel. In one aspect, a ratio of the vascular contact area to the total treatment area of the plaque staple 10 'is small. In this context, the vessel contact area is the sum of the area of the outer portions of staple 10 'which may come into contact with the vessel wall. More specifically, the vascular contact area may be calculated as a sum for all struts of the length of each strut multiplied by the mean transverse dimension (width) of the radially outer surface of each strut. When the struts of the zigzag rings have been laser cut, the width of the radially outer surface of the strut may be less than that of the radially inner surface. The vessel contact surface may also include the radially outer surface of the bridges 14. The overall treatment range of the plaque staple 10 'may be defined in terms of fully expanded configuration in an optimal fit cylinder. An optimum fit cylinder is one that has an inner circumference equal to the unrestricted perimeter of the plaque staple 10 '. The overall treatment area has an area defined between the proximal and distal ends (or lateral edges) of the plaque staple 10 '. The total treatment area can be calculated as the length between the proximal and distal ends (or lateral edges) in the best fit cylinder multiplied by the inner circumference of the best fit cylinder. In the illustrated embodiment, for the purpose of determining the total footprint, the length may be the distance in the same circumferential position between the high outer apices of the rings 12.

In various embodiments, the ratio of the vessel contact area to the total treatment area is less than 50%. In some embodiments, the ratio of the vessel contact area to the overall treatment area is even less, for example, 40% or less. The ratio of vessel contact area to total treatment area may be as little as 20% or less. In certain examples, the ratio of vascular contact area to total treatment area is 5% or even 2% or less. As discussed below, focal elevation elements may enhance this advantageous feature, and thus further reduce the ratio of the vessel contact area to the overall treatment area by providing separation between the vessel wall and at least a portion of the peripheral portions 12.

In certain methods, a vessel may be treated by the implantation of a variety of structures, such as a plaque staple 10 '. The structures have a total contact area with the vessel wall. The total contact area may be the sum of the vessel contact areas of the individual structures. In the method, an overall treatment area surface may be defined as a surface between the proximal end of the most proximal structure and the distal end of the most distal structure. In one method, the total contact area is no more than about 55% of the total treatment area area. Typically, the total contact area is between about 10% and about 30% of the total treatment area area. In certain examples, the total contact area is not more than 5-10% of the total treatment area area.

The staple 10 'may also be understood to provide a relatively large open area within its lateral edges as compared to stents. Unlike conventional stents, the staple 10 'need not include sufficient metal to provide a scaffolding function so as to hold a vessel open. In order to accomplish many of the contemplated treatments, the staple 10 'may be configured such that its contact is limited to only a single point or to a plurality of discrete points, such as one or more axial locations. The discrete points can be widely spaced, such as points on a circumference separated by distances, or, if used, by vascular tissue.

In some embodiments, the open area bounded by lateral edges of the staple 10 'dominates the entire footprint as defined above. The open area of the staple 10 'may be defined as the sum of the areas of the cells 16 when the staple 10' is in the fully expanded configuration as defined above. The open area should be calculated as the outer circumference of staple 10 ', such as the area extending between the internal lateral edges of each of the struts. In this context, the internal lateral edges are those that form at least part of the boundary of the cells 16. In various embodiments, the sum of the radially outwardly facing surface of the struts of staple 10 'may not exceed about 25% of the open area of staple 10'. More typically, the sum of the radially outwardly facing surface of the struts of staple 10 'is between about 10% to about 20% of the open area of staple 10'. In other embodiments, the sum of the radially outwardly facing surface of the struts of staple 10 'is less than about 2% of the open area of staple 10'.

A single pillar structure includes arrays in a plurality of staple cells circumferentially disposed about a central axis of staple 10 '. The staple cells are possible in many configurations, but generally include spaces surrounded by struts and are located in the wall surface of the staple. Open cell structures include arrangements in which at least some of a plurality of internally located struts of proximal and distal peripheral portions are not connected by bridges or axial connecting elements. FIG. 5C shows that the inner apex 19 is not connected to a corresponding inner apex on a mirror image ring 12. Therefore, a portion of cell 16, which is located above inner apex 19 in FIG. 5C, is open to another portion of cell 16 located below inner apex 19. Open cell structures offer more flexibility and expandability compared to closed cell structures in which each of the internally located struts of a proximal peripheral portion is connected to a corresponding internally located strut of an adjacent peripheral portion. Cell 16 would be interconnected by connecting the inner apex 19 to a corresponding one inner apex at the mirror image ring 12 divided into two closed cells. As stated above, closed cell plaque staples may be suitable for certain indications, and may include other features described herein. As shown, the open cell structure with the single column extends along the centerline C of the bridge (and along the perimeter of staple 10 'in this embodiment as well).

In one embodiment, the cell 16 is identical to a plurality of other cells 16 which would be circumferentially disposed about a central axis of staple 10 '. The number of cells may vary depending on factors such as the size of the vessel (s) for which the staple 10 'is configured, the preferred arrangements of the rings 12, the number of bridges 14 to be provided, and other factors ,

As noted above, the staple 10 'may include proximal and distal rings 12 connected by bridges 14. The proximal ring 12 may be disposed at a proximal end of the staple 10 '. The distal ring may be located at a distal end of the staple 10 '. In some embodiments, the distal ring is the distal aspect of the staple 10 ', and the proximal peripheral portion is the most proximal aspect of the staple 10'. The bridges 14 may divide an outer surface of the staple 10 'into cells 16 bounded by the bridges 14 and a portion of each of the proximal and distal rings 12. In the embodiment of Figs 5A-5C, the one-pillar Structure provided by the provision of bridges only in an axial position and by the provision of only a pair of peripheral parts or rings 12. Figure 5C includes the terms "distal" and "proximal" for reference in relation to this and other examples, therefore, the illustrated ring 12 is the distal ring. In other embodiments, the illustrated ring 12 may be the proximal ring.

As stated above, the cells 16 may have one of many different shapes and configurations. Figure 5B shows that the cells 16 are aligned in a repeating pattern to form an open cell structure with a pillar along the perimeter of staple 10 '.

Conventional stent structures are generally relatively long (e.g., 4 cm and even up to 20 cm when used in the peripheral vasculature), from their distal to their proximal ends. When arranged with circumferentially arranged cells, conventional stents have a large number of cell columns. These structures have repetitive vulnerabilities and can create stresses that are difficult to manage. When the device is subjected to stresses and strains, these conventional stents must seek areas of greater compliance within the strut matrix. These strut areas absorb the stress throughout the system and begin in phases where external forces repeatedly fail, such as by metallurgical friction loading.

The one-pillar configuration of staple 10 'is not susceptible to repeated stresses at weak points due to the movement of remoter stent parts because the staple need not be axially extended to provide effective stapling treatment. Other advantages that result from brevity include less friction at the interface with the catheter sheath during deployment and with the blood vessel wall. As noted above, the stress on the blood vessel wall interface is reduced by the lack of tensile and tearing forces from one cell to another, which in turn reduces the possibility that the staple will pull or pull adjacent cells, thereby causing increased cellular inflammation or can come to a histological response along the lumen wall. A column-type configuration or other axially short configuration also reduces the stress along each strut because the overall length of the single column or other axially short structures or configurations are less prone to anatomical movement (eg, bending, twisting, and turning). The reason for this is, at least in part, the displacement of the anatomy about short structures, while longer structures allow no displacement of the anatomy, whereby longer structures absorb more forces, resulting in this anatomical movement.

Any movement between the surface of the staple and the blood vessel may result in scuffing and friction. If the movement is very small, it can be described as micro-rubbing, as explained above. Even a micro-rubbing will adversely affect both the staple 10 'and the biological cells of the blood vessel. For example, friction occurs when one part of an implanted object is moving, while another part is stationary or moving to a lesser degree. A different amount of movement weakens the material over time, resulting in a fracture through processes such as solidification. The biological cells are irritated by the friction and can react with an inflammatory reaction. Inflammation can cause a variety of undesirable histological reactions, such as neointimal hyperplasia and restenosis. 2. Controlled strut angle [00110] FIG. 5C shows that the staple 10 'has two peripheral parts or rings 12, each having a plurality of internal angles, including angles α and σ. A first angle α is defined at the first outer apex 24 between the struts 26, 27, and a second angle σ is defined at the second outer apex 25 between the struts 28, 29. In some embodiments, the first angle α may be greater than the second angle σ. The first angle α may for example be between 43 ° and 53 ° or between 45 ° and 51 °. The second angle σ can be between 31 ° and 41 ° or between 33 ° and 39 °. In some embodiments, the first angle α may be about 48 ° and the second angle σ about 36 °.

In a preferred embodiment, the staple 10 'has an expanded outer diameter of 7.5 mm, and the first angle α may be 47.65 °, and the second angle σ may be 35.56 °. In such an embodiment, the plaque staple 10 'may be formed from a tube blank having an initial outer diameter of 4 mm. The tube blank can be expanded to 7.5 mm and then heat treated in this form. In some embodiments, the plaque staple 10 'may be made from a shape memory material, and the heat treating step may be to engrave that particular shape into the "memory" of the material. The plaque staple 10 'may then be crimped or compressed and frozen in the compressed state for loading onto a delivery device.

An advantageous feature of the staple 10 'is that the angle of the struts, as they meet each apex, can be controlled in at least one of the states - expanded and contracted. For example, the internal angles α, σ of the outer apices 24, 25 may be controlled to be within ± 5% of a selected nominal value. This control can be achieved, for example, in the expanded state during the heat treatment in the production of the plaque staple 10 '.

It has been found that the control of the angle advantageously counteracts defects in the manufacturing process. In some cases, control of other dimensions can be relaxed if these angles are adequately controlled. By controlling these angles, the quality of production runs can be improved. Such control has been found to allow the repeatable, consistent and balanced compressibility of staple 10 'during the crimp cycle of manufacture. These factors improve the repeatability of the production runs and provide easier mass production, which in turn reduces the overall cost of the part.

In addition, controlling the apex angle allows the plaque staple 10 'to better distribute the loads along the peripheral parts or rings 12. Control of the apex angles can be used to control or distribute the stresses within the ring 12, for example, uniformly along the length of the struts or not uniformly to an area that can more robustly respond to stresses. By distributing the load along the strut, the problematic local stresses on the staple 10 ', such as at sensitive locations, during fabrication expansion and crimping can be avoided. 3. Inverse tapered struts In some embodiments, as shown in Figs. 5A-C, the width of one or more of the strut (s) 26, 27, 28, 29 of the staple 10 'may be different at different locations, for example, it may vary along the strut. The struts may, for example, taper along their lengths. The taper can be the same or different along each strut or along each strut type. For example, each peripheral portion or ring 12 may consist of a pattern of repeating struts, each strut type having a particular taper.

Fig. 5C shows that the ring 12 has a first strut coupled to a bridge 14 that tapers so that a portion of the strut that is closer to the centerline C (occasionally referred to herein as a medial portion or medial position) is narrower than a portion of the strut farther from the centerline C (sometimes referred to herein as a lateral portion). A second strut is connected to the first strut at the lateral ends of the first and second struts. The second strut may have the same or a different taper. The second strut may also have a medial portion that is narrower than a lateral portion of the second strut. In addition, the second strut may be narrower overall than the first strut. A third strut may be connected to the second strut at the medial ends of the second and third struts. The third strut may have a medial portion that is wider than a lateral portion thereof. A fourth strut may be connected to the third strut at the lateral ends of the third and fourth struts. The fourth strut may have a medial portion that is wider than a lateral portion thereof. The fourth strut may have the same or a different taper than the third strut. For example, the fourth strut may be wider overall than the third strut.

Fig. 5C schematically illustrates differences in widths in one embodiment. In some embodiments, the long struts 26 and the long strut 27 have the same width in the same axial position, and the shorter struts 28 and the short strut 29 have the same width in the same axial position. The struts 26 and the strut 27 may have the same shape. Strut 28 and strut 29 have the same shape in some embodiments. The shape of the struts 26, 27 may differ from the shape of the struts 28, 29. In some embodiments, the long strut 26 and the long strut 27 have different widths in the same axial position, and the short strut 28 and the short strut 29 also have different widths in the same axial position.

In a preferred embodiment, the long struts 26, 27 are disposed in a first circumferential position of staple 10 'adjacent one of the markers 22. In particular, strut 26 has a medial end connected to or forming part of one of the inner apices 18 and a lateral end disposed on the inner apex 18. The lateral end is coupled to the strut 27 at or adjacent to the outer apex 24. The strut 26 has a width W4 adjacent to the medial end and a width W2 adjacent to the lateral end. In this embodiment, the width of strut 26 increases along the length thereof from width W4 to width W2. The increase in width along the strut 26 is preferably continuous along these lengths.

In addition, the sides of the struts 26 may decrease in relation to a longitudinal axis LA of the strut 26. For example, a first side 48 disposed between the longitudinal axis of strut 26 and strut 27 may be at an angle (eg, not parallel) to the longitudinal axis of strut 26. In another embodiment, a second side 46 of strut 26 may be disposed at an angle (eg, not parallel) to the longitudinal axis of the strut 26. In one embodiment, both the first and second sides 46, 48 of the strut may be disposed at angles to the longitudinal axis of the strut 26.

The strut 27 preferably also has different widths at different points along its length. In particular, strut 27 may be wider in a generally lateral direction adjacent outer apex 24 than adjacent inner apex 19. As discussed above in connection with strut 26, strut 27 may have side surfaces that are in relation to the longitudinal axis the strut 27 are angled. The strut 27 may taper between its ends, for example it may have a continuously decreasing width along its length, from a wider width adjacent the outer apex 24 to the narrower width adjacent the inner apex 19.

Strut 28 extends from strut 27 or inner apex 19. Strut 28 may have a medial end that is wider than a lateral end of strut 28, and may have different widths at different points along its length , The side surfaces may also be angled relative to the longitudinal axis of strut 28.

Finally, a strut 29 may be connected to the strut 28 or to the outer apex 25 at a lateral end of the strut 29. The strut 29 may have a medial portion that is wider than the lateral portion thereof. The strut 29 may have a taper equal to or different from that of the strut 28. For example, the strut 29 may be wider overall than the third strut.

In one embodiment, the strut 26 may have a width W2 of about 0.12 mm at the lateral end near the outer apex 24 and a width W4 of about 0.095 mm at the medial end near the inner apex 18, and the strut 28 may have a width W6 of about 0.082 mm near the outer apex 25 and a width W8 of about 0.092 mm near the inner apex 19. More generally, the change in thickness between W4 / W2 expressed as a percentage may be between about 70% and about 90%, more typically between about 75% and about 85%, and in some embodiments about 80%. The taper may also be inverted when, for example, the struts taper from the ends (eg, the lateral edges) to the medial part.

FIG. Figure 5E illustrates another variation in which the width of one or more struts of the staple may be different at different positions, such that they may vary along the struts, for example. For example, a strut 27 'may be provided that is similar to the strut 27, except that the strut 27' is narrowest in a central region N. The strut 27 'may have a laterally wide portion L adjacent the outer apex 28 and a medial width portion M adjacent the inner apex 18. The width of the strut 27 'decreases along the length thereof, from the lateral wide portion L to the medial portion M. In one embodiment, the strut 27' becomes continuously narrower along the length, from the lateral end of the strut 27 'to the centerline of the strut. The strut 27 'may be narrowed to such an extent that the ratio of the width at the centerline to the width at the lateral end of the strut 27', expressed as a percentage, is between 20% and about 85%. In some embodiments, this percentage is between about 35% and about 75%. The rejuvenation can be such that this percentage is between about. 55% and about 70%. From the medial wide part, the strut 27 'may narrow along the length thereof. In one embodiment, the strut 27 'becomes continuously narrower along the length, from the medial end of the strut 27' to the centerline of the strut. The strut 27 'may narrow to where the ratio of the width at the centerline to the width at the medial end of the

Strut 27 ', expressed as a percentage, is between 20% and about 85%. In some embodiments, this percentage is between about 35% and about 75%. The rejuvenation can be such that this percentage is between about. 55% and about 70%. The embodiment of Fig. 5E provides a wider range of compression and expansion in smaller diameter configurations. Smaller diameter configurations may be used in smaller body lumens, such as in blood vessels. For example, a staple having this configuration may be formed from a tube having a diameter of 2.3 mm, to which the embodiments of Fig. 5C are optimally formed from a tube having a diameter of 4.5 mm. The configuration of Figure 5E can be used to make staples suitable for a size 4 french delivery device. Staples configured as in Fig. 5E may have an unrestrained expanded size of about 4.5 mm and about 6.5 mm. In some embodiments, devices having the configuration of FIG. 5E may have an unrestrained expanded size between about 5 mm and about 6 mm, for example between about 5.5 mm and about 6.0 mm. One embodiment expands to about 5.7 mm when it is unrestricted.

A unique inverse taper or variation in width along the strut is achieved by inverting the orientation of the taper between the shorter struts 28, 29 and the longer struts 26, 27. The longer struts 26, 27 extend from a narrow width near the inner apices 18, 19 to a wider width near the higher outer apex 24. In contrast, the shorter struts 28, 29 are the opposite, with a wider width near the inner apices 18, 19 to a narrower width near the lower outer apex 25.

By strategically selecting the width of the struts, as discussed above, the plaque staple can disperse the stresses observed during compression and post-deployment. This feature can also help to control the load by more evenly distributing the load area along the length of the strut. In some embodiments, it may be desirable to distribute the stress unevenly to areas that can better handle the stress. 4. Dual amplitude struts [00127] As stated above, the ring 12 shown in FIGS. 5A-5C, via a wave-shaped sinusoidal pattern. The axial extent of ring 12 may vary around the circumference of ring 12, for example, providing a variety of amplitudes, as measured by the distance from an inner apex to an adjacent outer apex. The wavy pattern may have one or more amplitudes, such as the illustrated dual amplitude configuration. In the dual amplitude configuration, the majority of the struts 26, 27, 28, 29 extend between the inner apices 18, 19 and the outer apices 24, 25.

In some embodiments, the outer apices 24, 25 alternate between a high outer apex 24 and a low outer apex 25. In this context, "high" corresponds to a greater distance H1 than from a central region or centerline C of the staple 10 'measured, and' low 'corresponds to a smaller distance H2, as measured from the center line C (FIG. 5C).

The varying amplitude of the long and short sinusoidal struts described above may provide further control over the function of the plaque staple.

In particular, it may improve the compression of the staple 10 'so as to provide a greater change in the extent from the fully expanded configuration to a compressed configuration during the crimping process of manufacture. Greater compressibility simplifies deployment in smaller vessels and provides for a wider range of indications that can be treated as a delivery system of smaller cross-sectional profile is made possible.

The height H1; H2 of the apices is measured from the center line C to the top of the corresponding outer apices 24, 25. The sinusoidal pattern and dual amplitude plaque staple 10 ', such as that illustrated in FIGS. 5A-C, provides a wide range of adjustable diameters that can be readily scaled to various outer diameter configurations. The open-line one-pillar structure allows for a wide range of compression and expansion. The cause of this is partly the length of the strut, which is available for effective expansion. The ease of compression is associated with the position of the arranged apices Hi and H2 from the center of the staple, allowing these apices to compress in different positions rather than in the same lateral position. If Hi and H2 of the apices are aligned (for example, in the same axial position), they would press against each other during compression, thereby limiting the compression range.

[00132] Plaque staple compression areas 10 'were measured as 0.25 times the nominal pipe size in combination with expansion ranges up to twice the nominal pipe size, although these are not the expected limits of the device. By combining these ranges, the full compression range was measured to be 0.125 times the heat treated outer diameter. As stated above in SECTION II.B.2, in some embodiments, the tube size is 4.5mm and the tube is expanded to 7.5mm in the manufacturing process. According to some embodiments, the distance from the center line C of the device to the apex of the longer struts Ηί is about 3.0 mm, whereas the distance H2 to the apex of the shorter struts is about 2.6 mm.

Apart from the optimized compression range, the energy stored in the shorter amplitude struts provides additional control of the plaque staple 10 'during the release phase of blood vessel deployment. As the catheter sheath is withdrawn, first the longer struts are exposed, followed by the shorter struts (FIG. 5C). This discrepancy provides stronger retention forces for holding the plaque staple 10 'in the delivery catheter, thus providing better control of the plaque staple in delivery. 5. Central Anchoring and Lifting Structure [00134] Figs. FIGS. 5A-5C illustrate that the plaque staple 10 'may include centrally located anchors 20. While anchors 20 serve primarily to fix loose plaque as noted above, their placement and configuration will optimize control over the delivery and performance of staple 10 'once placed in the blood vessel.

As stated above, the plaque staple 10 'may be a self-expanding peripheral structure, and the anchors 20 may be disposed on an outer portion of the staple. The anchors 20 may be coupled to any part of the staple 10 ', but are preferably located adjacent to the centerline C of the bridges 14, as discussed above. In one embodiment, the staple 10 'includes two anchors each disposed on one side of the centerline C as shown in Fig. 5C. In one embodiment, a single anchor may be provided on the centerline C. In another embodiment, at least three anchors 20 may be provided, such as one on the centerline and one on each side thereof, as shown in FIG. 5C. The bridge 14 may have two anchors on one side and an anchor on the other side connecting the two other anchors, as shown in Fig. 5D. In Fig. 5D is an anchor 20 'in the middle of staple 10', along its axial direction. This embodiment provides at least one anchoring 20 'which is located on both sides of the center line C. In addition, the anchor 20 'may be on an opposite side of the marker 22 from the anchors 20. Accordingly, the plaque may be anchored from a variety of directions, such as a variety of circumferential directions. In another embodiment, the anchors 20 are absent and there is a single anchor 20 'on the

Centerline C provided. The in FIG. 5A-C could also be modified to include one or more anchors on each side of the marker 22 where anchors are currently displayed on only one side.

In one aspect, the plaque interaction of the staple 10 'is provided substantially by the anchors 20 and, to a lesser extent, by the bridges 14. In some embodiments, the anchors may have a preferred penetration length into the plaque of 0.01 to 5 mm. In certain variations, the penetration length is within a range of about 0.03 mm to about 1 mm. In other variations, the penetration length is within a range of about 0.05 mm to about 0.5 mm. The bridges 14, which may be arranged on alternating inner apices, as stated above, may be configured to lie on a tangential plane of a cylinder when the staple 10 'is fully expanded and that they are not deformed by an external structure , The tangent configuration causes the anchors 20 to project outwardly from the cylindrical surface of staple 10 '. In this outwardly projecting position, the anchors are adapted to fix plaque or other vascular deposits through which the vessel varies from its unrestrained solid state, for example, having an imbalance.

The tangential projection of the anchors and bridges also advantageously improves control over the staple 10 'in the provision. A method of providing the staple 10 'includes positioning the staple in a hollow catheter body. When positioned in the catheter body, the staple 10 'is compressed to a compressed state. The rings 12 are by their execution, as explained above, extremely supple. As a result, the rings nestle completely against the luminal inner surface of the hollow catheter body. In contrast, the bridges 14 and 20 are more rigid and therefore less pliable, and as a result they become entangled in the luminal inner surface of the catheter body. This creates a retention force in the catheter and unintentional movement of the staple 10 '- partially or completely - in the direction of a catheter delivery area is limited.

In some embodiments, the retention force of the barbs 20 is maintained or increased after the partial provision of staple 10 '. A range of relatively high flexibility may be provided in particular at the junction of the bridges 14 and the rings 12. Although stent areas of high flexibility can also be problematic areas, this is not the case for the plaque staple 10 'given below. The flexible region may have any material property or structure to improve its flexibility, at least compared to that of the bridges 14, such that as the ring 12 moves along the leading delivery edge, the tan-gentielle configuration and tendency of the anchorages 20 in the Hollow elongated catheter body is not reduced. This is the case even if the leading edge ring 12 expands, if necessary, to at least half of its fully expanded size.

As illustrated, the bridge 14 is connected to each ring on the inner apex 18 where at least a portion of the bridge 14 may be partially or substantially aligned with one of the struts forming the ring 12, as previously described. For example, as already illustrated, the bridge 14 is aligned with a sinusoidal region having a high amplitude of the pattern. The region of relatively high flexibility may be located between the inner apex 18 and the bridge 14.

In certain embodiments, the expansion of the ring 12 may even cause the anchors 20 to rotate outwardly to increase the retention force in the catheter body. For example, the expansion of the strut 26 may lead to a deflection inward of the inner apex 18. As ring 12 expands, the anchors 20 may easily rotate, which may result in a torque deflection of the front anchorage outwardly and a corresponding outward anchorage torque deflection. With reference to FIG. 5C, when illustrated

Ring 12 is expanded for the first time as it moves out of the hollow catheter body, the anchor 20 is deflected inwardly toward centerline C of the catheter body, but the anchor 20 on the left is deflected outwardly to increase the retention force thereof , Thus, the plaque staple 10 'may be retained in the catheter during such partial expansion. Due to this function, the plaque staple 10 'can be placed evenly, as explained in greater detail in Section II.B.8 below.

The nature of the bridges 14 and anchors 20 to lie outside the cylinder also provides benefits for the condition provided. In particular, in some embodiments in an expanded state, the plaque anchors 20 are disposed radially outward from a cylindrical surface formed by the rings 12. The extent of the "off-cylinder" nature may depend on the application, but in general it suffices to space at least a portion of the cylindrical surface from the inner walls of the vessel trunk upon deployment. Thus, the anchors 20 or the anchors in combination with the rings 12 may be configured as focal elevation elements, which are discussed in more detail below in SECTION III.

As the plaque staple 10 'expands in a blood vessel, the struts engage the vessel wall and / or plaque. It is believed that in most situations, at least some of the struts will deform as a result of irregularities in the shape of the blood vessel. At the same time, the bridges 14 are less malleable and thus resist such deformations while maintaining a circular configuration. The outward forces exerted by the strut members are transmitted to the areas which contact the blood vessel wall. In some cases, as the staple 10 'follows an irregularly shaped blood vessel lumen, the rigid central anchorages become the area where the blood vessel is contacted. The cumulative outward force of the struts in the rings 12 is exerted on the anchors via the bridges 14. The adjacent struts share their load with the contact area, the blood vessel being pressed in an enlarged configuration, such as a shaped circle.

This configuration may offer advantages such as helping the plaque staple 10 'remain in place after deployment and permitting the plaque staple 10' to respond dynamically to the movement as well as the plaque staple 10 ' Pulsation of the blood vessel per se. In addition, this configuration may have the benefit of diminished cell response and device fracture by limiting strut fatigue and associated microfabrication built up at the staple / blood vessel interface.

In some embodiments, bridge 14 may include one or more anchors. In some embodiments, the bridge may be formed entirely of anchors.

After providing the plaque staple 10 ', the surgeon has the option of placing an angioplasty balloon at the stapling site and inflating the balloon to access the anchors 20 into the plaque and / or wall of the blood vessel to press. 6. Flat Midline Markers As discussed above, the plaque staple 10 'has one or more markers 22. In one embodiment, a series of radiopaque markers 22 may be located on the staple 10'. In some embodiments, the radiopaque markers 22 are located on the centerline C of the device. The radiopaque markers 22 may be disposed between the two circumferentially oriented sinusoidal portions or rings 12.

In some embodiments, the radiopaque markers 22 (such as platinum or tantalum) may be disposed adjacent to the plaque anchors 20. The radiopaque markers 22 may take one of many different shapes or configurations. In some embodiments, the radiopaque markers 22 have a planar or flat structure. As shown in FIG. 5C, each marker 22 is coupled to an annular eyelet, for example, by press-fitting or riveting, thereby providing a flat, flush surface with the eyelet. The markers 22 provide clear visibility of the staple 10 'in the catheter delivery system and provide guidance to the clinician in accurate placement during the procedure.

According to certain provisioning methods, because of the common placement of the anchors 20 and the markers 22 on the bridges 14 between the sinusoidal rings 12, the markers 22 can provide the clinician with a visual indication of the point at which the device is released becomes. For example, after the markers 22 have located a marker strip at the tip of a delivery catheter sheath, the complete device can be provided.

At this point, a schematic representation of a staple 10 'is shown with reference to Fig. 5C1. As shown, the anchor 20 has an increased material thickness compared to the rest of the staple. As a result, the anchoring 20 also has an increased radiopacity compared to the rest of the staple, effectively converting the anchoring into a marker. 7. Simultaneous Device Placement in Vessel [00150] The plaque staple 10 'may be configured for simultaneous placement within a blood vessel. The simultaneous placement of the staple 10 'may be defined to release the entire plaque staple 10' from the delivery catheter before one of the distal apices of the plaque staple 10 'contacts the blood vessel lumen where it is to be placed. This event may occur when the anchors 20 are completely exposed from the catheter sheath so that the entire plaque staple 10 'can expand against the lumen wall of the blood vessel. The struts 26, 27, 28, 29 may be levitated, for example, spaced from the vessel wall, or they may exert a negligible force on the wall so that they do not contact the lumen wall prior to simultaneous placement. The anchors 20 may have the effect of spacing a portion or substantially all of the struts 26, 27, 28, 29 from the vessel wall. In the following there will be explained other forms of focal elevation elements that can be used to space the staple 10 'from the lumen wall.

The simultaneous placement provides the clinician with the ability to control the placement until the markers 22 and / or anchors 20 are exposed, which may result in a complete expansion event (struts adjacent the lumen wall or struts contacting the lumen wall). In some embodiments, the full expansion event does not occur until the anchors 20 have been exposed, which is essentially due to the internal forces of the staple 10 ', which require the anchors 20 to anchor the staging envelope described above.

Another advantage of simultaneous placement is the reduction of any accidental pulling or squeezing of the struts against or along the luminal surface during placement of the plaque staple 10 '. Due to the complexity and variation of disease, placement position, and dissection morphology, the ability of the outer surface of the plaque staple 10 'to contact the lumen wall at the same time is dependent upon the delivery circumstances. However, the ability of plaque staple 10 'to fully contact the lumen wall upon release from the catheter sheath within fractions of a second was observed. 8. Low Slope Force Curve [00153] Another unique aspect of this plaque staple 10 'is that it can be configured with a force curve with an expanded surface and a low pitch. A force curve such as that shown in FIG. 6A indicates the amount of expansive force exerted by a self-expanding plaque staple 10 'or stent upon movement from a compressed state to an expanded state. This expansion force of a device can be a factor in choosing the right device for placement in a particular blood vessel.

Continuing to refer to FIGURE 6A, the force curves of a SMART stent (i.e., a S.M.A.R.T.® controlled transhepatic bile stent from Cordis Corporation), another conventional stent, and another plaque staple are the same as those shown in FIGS. 5A shown wall pattern. The graph shows the radial force in Newtons (N) on the y-axis and the outside diameter of the device in millimeters (mm) on the x-axis. As the device expands or moves from the compressed state to the expanded state, the outer diameter increases. Because the devices are self-expanding, they have a fixed amount of stored potential energy. Upon release, the potential energy is converted into kinetic energy, while the internal forces try to return the device to its expanded form. The kinetic energy may then have an effect on the blood vessel when the device is implanted. When the plaque staple 10 'is not fully expanded, a generally constant force is applied to the vessel wall that matches the residual potential energy stored in staple 10'.

Fig. 6A shows a first dark line A1 indicating the compression of a 7.5 mm plaque staple 10 'of about 7.5 mm to a compressed diameter of about 2 mm. After a gradual slope range of between about 7.5 mm and about 6 mm, the inclination of the force for each incremental diameter reduction is greatly reduced, requiring a narrow force band to complete the staple 10 'from about 6 mm to about 2 mm to compress. This part of the force curve is very flat, d. H. the applied compressive force does not increase significantly as the staple 10 'approaches its fully compressed state. The force curve of the plaque staples 10 'during expansion is represented by a dark line B1 extending from a compressed diameter of 2 mm to an expanded diameter of about 7.5 mm. This part of the curve may be considered as a working part in which the force on the y-axis is the force that the plaque staple 10 'would exert upon expansion on a vessel wall. For example, if the plaque staple 10 'were to be provided in a vessel lumen having a bore of about 5.0 mm, the outward force of the staple 10' on the wall would be well below 1.0 Newton (N). Over a range of about 2 mm, the range of outward force is less than about 0.05 N +/- about 30%.

Fig. 6A shows in a paler line A2 the crimping performance of a SMART stent in a similar test. As discussed above in the context of other prior art stents, the SMART stent is a longer structure than the plaque staple 10 '. In particular, the tested S.M.A.R.T.® stent was 40 mm long, with an unlimited outside diameter of 8 mm, whereas the tested staple was 6 mm long, with an unlimited outside diameter of 7.5 mm. However, it is believed that the comparison between the plaque staple 10 'and the SMART stent illustrates a difference that would also be similar in a SMART stent design. As shown in the diagram, line A2 has a much higher crimp force in a range of just over 8 mm to about 6.5 mm. At about 6.5 mm, the tendency of the crimping force decreases and the crimping force increases at a much slower rate. The outward force in the fully crimped state is much higher.

Although the fully crimped state of the SMART stent corresponds to a smaller diameter, the crimp force for a comparable diameter is much higher for the SMART stent. Line B2 illustrates the work area of the tested SMART stent. Line B2 shows the outward force over the expansion range of about 2 mm to about 6 mm. It can be seen that the inclination of the line B2 is much greater at all points along its range between 2 mm and 6 mm. The practical effect of this higher slope is that the SMART stent is much more sensitive to changes in bore size

Vessel in which the expanded plaque staple 10 'is provided reacts.

As shown in FIG. As shown in FIG. 6A, in some embodiments, a lesser slope of the force curve may be substantially flat over an expansion range having an outer diameter of about 3 mm. In other embodiments, a low slope of the force curve may extend over an expansion range having an outer diameter of 2.5 mm, with a force change of less than 1 N. The factors relating to the ability of the staple to cover a wide range, with the radial forces being around change less than 1 N, include u. a. the centerline anchors, dual amplitude struts, and varying strut thicknesses as described above.

[00159] FIG. 6A illustrates another conventional stent with a compression curve A3 and an expansion curve B3. The SMART stent is a common stent pattern. The curves A3, B3 represent another conventional stent structure.

Although the curves A3, B3 have a lower peak compression force on the left side of the curve, the inclination is still significantly higher than the area of use as compared to the staple, as illustrated by the curve A1, B1.

The staple is radially self-expandable, in a range of at least about 2 mm, generally at least about 3 mm, and typically over a range of at least about 4 mm or 5 mm, while a radial expansion force of not more than about 5 N occurs at any point in the entire area. In some embodiments, the maximum radial expansion force over the entire expansion range is not more than about 4 N, and preferably not more than about 3 N. In one embodiment, the staple is expandable over a range of at least about 3 mm (for example, from about 3 mm to at least about 6 mm) and the radial expansion force is less than about 3 N within this range. In general, the change in the expansion force is not more than about 3 N, and preferably not more than about 2 n within the expansion range. In one embodiment, the expansion force of not more than about 2N at a diameter of 3mm falls to not more than about 1N at a diameter of 6mm. The difference between the radial compressive force and the radial expansion force at any diameter throughout the expansion range is usually not more than about 4 N, generally not more than about 3 N, preferably not more than about 2 N and in one embodiment not more than about 1 N. In one implementation, the staple is expandable over an entire area that includes 3 mm to about 6.5 mm, and the difference between the compressive force and the expansion force at each point along the compression / expansion area is no more than about 2 N, and preferably not more than about 1 N.

In general, the outward force of the plaque staple 10 'is preferably as low as possible while providing sufficient force to push the plaque against the wall in a wide range of luminal diameters. When the force is increased, for example by twice or three times the sufficient holding force, side effects may occur. These can u. a. irritation of the cells of the vessel wall in contact with the device may result in restenosis. Although a device with a very low force is preferred in the typical treatment, higher force devices may be helpful if loose plaque is found in calcified lesions.

An advantage of a slow force change during the expansion of the device is the ability to predict the energy experienced by the blood vessel, regardless of the lumen diameter. Another criterion would be to reduce the necessary stock for hospitals. For example, it has been found that two part sizes of the staple 10 ', as shown in FIGS. 5A-C, for plaque stapling in blood vessels throughout the leg, from the hip to the ankle. It is believed that this is largely due to the staple 10 'having an inclination of less than -0.3 N / mm. C. Parameters of the Plaque Staple Structure One purpose of the plaque staple described herein, which differs from conventional stenting, is to minimize the amount of implanted foreign material while continuing to perform focal treatment of the blood vessel condition so as to cause a minimal reaction of the blood vessel wall and an adverse restenosis after the treatment. The plaque staple is designed to result in substantially less metal coverage and / or substantially less contact with the blood vessel surface, thereby causing less acute and chronic inflammation (see FIGURE 6B). A reduced contact area of the implanted material with the blood vessel wall correlates with a lower incidence of intimal hyperplasia and better long-term patency. A substantially reduced length along the axial distance of the blood vessel allows more targeted treatment, correlates with less severe foreign body coverage of the blood vessel surface, avoids covering portions of the surface that do not require coverage, and correlates with both early and late improved patency of blood vessel reconstructions.

The plaque staple can be provided only where it is needed to staple plaque that has been released by balloon angioplasty or other mechanisms. Rather than covering an entire treatment area, the plaque staple may be placed locally and selectively so that it does not extend, for example, to normal or less diseased arterial segments (see FIG. 6B). As a result, the blood vessel retains its natural flexibility because there is minimal or no scaffolding effect when a flat staple is inserted locally, or even when multiple staples are placed across the treatment area. An even further reduction of the pressure profile can be achieved through the use of "points of contact" so as to create a higher pressure at the focal points and lift the adjacent strut portion away from the blood vessel wall, thus increasing the overall stress on the outward acting pressure elsewhere in the staple strut structure.

A plaque stapling conception parameter has a ratio of axial staple length to expanded diameter (L / D) of not more than about 2.0, often not more than about 1.5, and in some implementations of not more than about 1. In some embodiments, the staple has approximately an L / D ratio of 0.8. That is, the length of the staple along the axis of the blood vessel is approximately equal to the expanded staple diameter or smaller than the expanded staple diameter. The preferred plaque staple is thus shaped like an annular ring or band, whereas the typical stent is shaped like an elongate tube. The flat staple can thus be used locally for the targeted treatment of defective areas of the blood vessel surface with a minimum of foreign material coverage or contact. Tests show that a plaque staple having an axial length / diameter ratio of <1 compared to a conventional stent where the axial length is greater than the diameter - and usually significantly larger - has virtually no biological response or subsequent blood vessel constriction causes. Tests show that an L / D ratio of the device of <1 leads to a reduction of the scaffolding effect to a value significantly lower than that of the typical stent and that it causes a less severe response of the arterial wall. For use at small dissections after balloon angioplasty, a minimum profile plaque staple may be used, such as a single thin ring type staple having an L / D ratio in the range of 1:10 to 1: 100.

Stenting studies have shown that the axial length of a stent correlates with a tendency to occlude in multiple vascular areas. The more axial stent length has been placed, the higher the likelihood that the reconstruction will fail. The axial length of a stent also correlates directly with the frequency and tendency of the stent to break when placed in the superficial femoral artery. The medical

Literature indicates that the superficial femoral artery behaves like a rubber band, and that changes in the natural lengthening and contracting of the superficial femoral artery are likely to play a significant role in the failure of superficial femoral artery stents. In contrast, the flat plaque staple can be implanted only in localized areas where it is needed, thereby preserving the natural flexibility of the blood vessel to move and flex even after stapling. Multiple staples may be implanted by area separately free of metal supports, leaving the artery free to more naturally flex.

An outward-acting radial pressure exerted on the blood vessel wall can also be significantly reduced by the flat staple structure, even when multiple staples are used in a spaced-apart configuration. To minimize this outward force while still providing the required retention of the dissections on the arterial wall, a series of anchoring barbs or focal lifting elements can be used. The presence of these features, which exert focal pressure on the wall of the artery, allows the remaining staple to exert a minimal outward force on the arterial wall. The points on which the force is exerted can be very focal, this is where most of the force is working. The focal nature of the pressure exerted by the staple also minimizes the structural effects of the device. Uniformly distributed anchors or focal elevation elements can provide a distribution of radial energy, thereby maximizing the tendency to form a circular lumen.

Another important parameter for the generation of a plaque staple is the ratio of vessel covering area (C) to the total vessel surface area (TVS). In one definition, the value C is the length of the prosthesis (eg, of the stent or staple) multiplied by the mean perimeter of the vessel in which it is placed, and the TVS value may be the length of the lesion or area which requires treatment multiplied by the same nominal size. This can also be simplified as the ratio of the total length of the prosthesis expanded to the nominal size divided by the length of the lesion in the vessel. These concepts can be applied to a staple device or to the case where a plurality of spaced staple devices are placed along the length of a blood vessel treatment area. If multiple stents or staples are used, a simplified ratio may be the total non-overlapping length divided by the lesion length, or alternatively the sum of the length of the prosthesis divided by the sum of the length (s) of the lesion (s). For a plaque staple, the ratio of C: TVS is in the range of about 60% or less, whereas for a stent it can be 100% or more (if the application is made to overlap the treatment area).

In a focal lesion, the conventional length of a treated vessel is X + 10mm to 20mm, where X is the length of the lesion and the added length is adjacent to a normal or less diseased artery located proximal or distal to the lesion located. In conventional stenting, the total treated vessel length would be covered by a stent. Thus, for a 2 cm lesion, the treated vessel length would be 3 to 4 cm (usually a single stent of this length would be selected), so that a ratio of C: TVS would be 150% -200%. In contrast, setting a staple would cover only about 1/2 of X and no portion of the adjacent normal or less diseased artery would be treated. For a lesion of 2 cm, about 1 cm would be covered so that the ratio of C: TVS would be about 60% or less. An advantageous aspect of this innovative approach is the placement of bands only in areas where there are dissections that need to be stapled vascularly.

As previously described, in some embodiments, a staple device 10 'is formed with rings or mesh bands 12 connected by longitudinal bridge members 14 (FIG. 5A). Shown in the figure is staple 10 ', which is compressed for delivery in a blood vessel. During expansion, the diameter of the stapler device may be approximately equal to the axial length of the stapler device.

FIG. Figure 6B illustrates the use of multiple staples spaced a length of a blood vessel at a treatment site as compared to that of a typical stent. The spacing between the staple devices is preferably at least the axial length of the stapler device. Note that the spacing of adjacent staple devices leaves an untreated vessel area. A typical stent is shown in the upper part of the figure compared to using 6 offending staple devices in the lower part of the figure. In this non-limiting example, the total length of the treatment area is 6.6 cm (same length as the stent), whereas each band with a length of 6 mm and a spacing of 6 mm. Therefore, the vessel covering area for the stent is equal to the total vessel surface area (= 6.6 cm x 0.6π or 12.44 cm 2), giving a ratio of C: TVS of 100%. For the series of spaced staplers, C is equal to 6 x 0.6 cm x 0.6π or 6.78 cm 2 while TVS is 12.44 cm 2, so the ratio of C: TVS is equal to 54.5%.

Conventionally, when two or more stents must be placed over a longer length of treatment site, it is common practice to overlap adjacent stents to avoid kinking between the stents. The reinforced metal grid makes the overlapping area very rigid and uneven. This awkward double-rigid area further restricts the natural flexibility of the artery and increases the tendency for restenosis. Stent fractures occur more frequently in the superficial femoral artery when there are frequent bends, and they are common when multiple stents are deployed and overlap. Stent fractures are associated with a higher risk of sternal restenosis and reocclusion. In contrast, the plaque staples are designed to be non-overlapping in the local area. The optimum spacing for the staples is at least 1 axial staple length apart. This allows the artery to maintain its flexibility and only half or less of the treated length of the artery is covered with metal. It should be noted that in the case of restenosis after stapling, the overlap of the entire treated length by a stent will still allow the stent to permeate. This is due to the repeated pattern of areas where staples are not set, providing relaxation areas and allowing the artery to bend.

The literature in the industry has found that important factors in the stent structure can be the Relative Metal Surface Area (RMS) ratio and the number of longitudinal segments in the device structure, as set forth, for example, by Mosseri M, Rozenman Y, Mereuta A, Häsin Y, Gotsman M., "New Indicator for Stent Covering Area," in Catheterization and Cardiovascular Diagnosis, 1998, v. Chr. 445, pp. 188-192. In particular, for the respective metal surface area, a larger number of longitudinal segments (each being thinner) may reduce the size of the gap between adjacent segments and thus reduce the prolapse tendency. As adapted from the RMS measure, an effective metal interface (EMI) equation can be used to compare the embodiment of the staple device with longitudinal bridge members to a typical stent, as follows:

Where x is a number of the metal sections, I is an individual metal section length, w is an individual metal section width, C is the vessel coverage area under the device (lumen surface), and n is the number of bridge parts connected longitudinally between the circumferentially aligned segments. The summation in the denominator can be interpreted as the total metal surface area. The embodiment of the stapling device with the longitudinal bridge parts has an EMI <10, whereas the EMI of a typical stent around

Many times higher. This low EMI is due to the nature of the staple structure, which has a small area and minimal longitudinal bridges, while a stent usually has a large area and would be a multiple thereof.

In order to further reduce EMI during acquisition of from-bump lift features (such as anchors, barbs, or focal lift members), improved EMIf for the effective metal interface of the staple as provided with levitation members may be obtained (see FIG. 9). EMIF can be defined as:

[00177] Where all variables correspond to those in the EMI equation, with the addition of 1F as a single metal section length not in contact with the artery ("floating away" from the artery) and wF being the width of the same section there are no floating sections, nF = 0 and lFwF = 0, so EMIF = EMI.

The inclusion of metal sections that float (suspended length IF, floating width WF and number of floating bridges NF,) further reduces the EMI, which is mathematically detected as addition with negative variables in the EMIF equation.

The presence of knockout features on the plaque staple (such as anchors, barbs, or focal elevation elements) minimizes the pressure of the overall structure on the blood vessel wall by transmitting regionally-occurring, outward forces to focal pressure points focal points a higher pressure is applied. The presence of these features, which exert focal pressure on the wall of the artery, allows the remaining staple to exert a minimal outward force on the arterial wall. Wherever the hump lift features are located, the outward radial energy is maximized in that area, creating a slight outward curvature of the arterial wall. The outward curvature may be used for arterial shaping or shaping, for example, 5 or more evenly distributed focal points may be used to form a circular lumen. Circular lumens provide an additional benefit from the vascular wall interaction perspective, regardless of vascular injury.

In any of the embodiments described herein, the nitinol plaque stapling device, a silicone composite (with or without inert coating) may be polyglycolic acid or other superelastic material, as well as stainless steel, tantalum, a cobalt chrome alloy, bioabsorbable or bioabsorbable materials (including bioabsorbable / bioabsorbable metal) or a polymer. The strip of material may be ribbon, round or rectangular wire, or a sheet of material that may be made by photolithographic processing, laser or water cutting, chemical etching or mechanical removal of the final shape, or the use of bottom-up fabrication, for example chemical vapor deposition processes or injection molding, hot rolling or the application of electroplating / chemical coating. It can be made of a metal, plastic, ceramic or composite material.

The plaque stapling device is designed to be inherently self-aligning, i. H. Their mechanical installation can compensate for minor misalignments. By reducing the stress in the strut members when grasping the arterial wall in the center of the structure, the staple automatically aligns with the arterial longitudinal axis. Structural functions that provide relief and uniform distribution of deploying struts are among others. a. tight spacing of the anchors, unevenly thick struts and anchoring heads angled to reduce forward speed of the device during deployment. As discussed above, circumferentially-oriented anchors on each bridge portion provide gripping force with the catheter tip, as well as inherent features on the arterial wall. These structural features serve to facilitate the placement of the staples in certain locations within diseased blood vessels.

III. IMPROVING FOCAL LIFTING ELEMENTS

[0018] FIGS. Figures 7A-D show a plaque staple 10 "similar to that of Figures 5A-C, except as noted below The plaque staple 10" includes, in particular, a feature that determines the amount or character of the interactions between plaque staple 10 "and the vascular trunk when provided by the raising and lifting of a portion of the plaque staple 10" away from the vessel wall.

In particular, the high outer apex 24 'formed by the struts 26 and 27 is bent or turned upwards or positioned radially outward to form a focal elevation element (FEE) 32. FIG. 8 shows a schematic view of the FEE 32. In this embodiment, the high outer apex 24 'is bent to form an angle with the struts 26 and 27. In this way, the FEE 32 can help minimize the size of the area of the staple 10 "that comes in contact with the plaque and / or the vessel wall, while at the same time locating the forces at a few points to secure the plaque staple 10". safer to place. These and other advantages are discussed in more detail below.

A plaque stapling device may be provided with focal elevation elements at the annular periphery of the device. The focal elevation elements can be distinguished from the anchors and barbs in that they generally have greater plaque or arterial wall penetration for anchoring or stabilizing the staple in the blood vessel.

The focal elevation elements do not penetrate or penetrate but continue to provide regional strut elevation and are preferably placed at the apices of the struts or at regular intervals along the (eg perpendicular to) strut lengths. For both anchors and focal elevation elements, the size of the interface between the staple and the arterial wall is preferably equal to or shorter than the strut width in at least one direction. The focal elevation members may be similar to the anchors, but either they do not penetrate the tissue, or only slightly, minimizing the size of the material surface area that is in contact with the plaque, and providing a series of relaxation sections for the outward pressure of the stapler device adjacent to the focal elevation elements, thus minimizing the friction created on the blood vessel wall.

The focal elevation members may be described, shaped and configured at the annular periphery of the stapler in a manner similar to the previous stapler embodiments, and may additionally include the raised contact portions for anchors or prongs. The contact areas can provide improved stapling characteristics in that they increase the contact forces in the contact areas by compressing the plaque in the contact areas and reduce the outward forces in the areas adjacent the focal elevation element. This results in regional pressure relaxation in some areas as well as increased contact pressure at the humps or tines, which collectively provides a reduction in the trauma and cell response of the blood vessel wall.

Because the stapler device is held in the desired position by its own pressure exerted on the surface of the blood vessel, it is susceptible to friction, including slight movement between the device and the vessel surface. Every movement of the organ (eg, the leg when bent) causes the artery to move. It can be concluded that as the artery moves, the working device located in the artery also moves, but not necessarily every contact point moves synchronously. Whenever there is a small discrepancy in the movement between the artery and device, the artery and device rub against each other, promoting a cellular response and failure of the device. From experiments it could be deduced that this rubbing can irritate the endothelium and lead to an inflammatory reaction. In some embodiments, strategically placed focal enhancement elements (FEEs) are implemented to reduce the general regional friction load (as a source of inflammation, cell proliferation and for the healing reactions that lead to restenosis) in the area that is kept open.

By way of example, it is assumed that a blood vessel, such as the popliteal fossa, which is cylindrically shortened and elongated, has cell or tissue structures which extend and compress in a direction parallel to the vessel axis. The natural behavior of this cellular structure or tissue structure involves a significant degree of local motion along this axial direction. When an implant to be placed in such a vessel is designed to contact the vessel wall in a direction transverse to the axial direction, the natural behavior of these tissues or cells is significantly disturbed. For example, the tissue is restricted and the natural movement is significantly reduced. It can also cause chafing at the edges of the transversally contacting structure, which can lead to friction and / or abrasion of the tissue and corresponding inflammation. FEEs, on the other hand, reduce the disruption of the natural behavior of the tissue or cells. When implemented in a stapler or other prosthesis, FEEs may focus the contact in areas that are spaced along a direction transverse to the prevailing direction of motion (eg, the axial direction of the popliteal fossa or similar vessel). Between these areas of focused contact according to the FEEs, the interaction of the compressing and extending tissue (s) with the structure of the implant is significantly reduced. In this intermediate region, the movement between the compressing and extending tissue (s) may approach the movement of the tissue (s) before implantation of the prosthesis.

Raised areas from the FEEs limit the histological response of the tissue and also the fatigue of the device by limiting the contact between device and tissue.

Regardless of the general number of contacts and the number of FEEs, the stapler devices smooth the lumen wall and allow a more natural vascular motion. The FEEs are very helpful, prolonging / extending or compressing / compressing their ability to reduce the level of interaction between the tissue (s) that move (s), thereby causing scouring or friction on that tissue these cells can arise. It is this highly localized movement or "micro-movement" which increases the cellular response of the blood vessel surface to the foreign device.

The focal enhancement elements are designed to reduce the effective metal interface (EMI) by minimizing the general material contact with the blood vessel surface. The focal elevation member (FEE) is preferably configured as a narrow raised feature of sufficient height to lift adjacent strut portions of the stapler device away from contact with the arterial wall so as to reduce the surface area of the foreign material in contact with the arterial wall. Reducing the contact load is particularly useful when the strut members are circumferentially connected rings or circumferentially oriented strut bands. Toward the natural direction of cell movement, strut sections that are in contact with the blood vessel wall can result in microfibrillation as they move or rub against the blood vessel walls. Reducing the foreign material contact with the blood vessel wall reduces the tendency of micro-contact contact generation.

[00192] Referring to FIG. Figure 9 illustrates a schematic representation of some of the structural assumptions regarding the use of focal elevation elements on a plaque stapling device. In the figure, h refers to the height of the focal elevation element that is extended out of the blood vessel (Note: the penetration depth of the focal elevation element anchored in the artery or plaque body was not considered in this calculation) w is the width of the focal elevation element (at the base) and lF refers to the surface of the adjacent strut lifted off the arterial wall (mathematically simplified as a straight line). The struts adjacent the focal elevation element may be fabricated from shape memory materials or designed as a compression wave that compensates for variations in luminal diameter. The forces of the struts adjacent the focal elevation elements create an outward curvature of the struts, created by the forces of the struts that want to expand until they are in contact with the blood vessel wall. IA refers to the length of the arterial wall which prevents contact with any adjacent strut structure by the focal elevation element.

[00193] One or more of the features shown in FIG. 9 may be varied to provide favorable FEE performance, h may vary, for example, in the size of the delivery catheter. For example, a 4FR provides an h of up to 150 pm. In certain embodiments, a staple with FEEs configured for deployment in a 4FR catheter may have an h of about 100 pm or less. An exemplary embodiment that may be provided with a 4FR delivery system has one or more FEEs with an h of about 75 pm. Larger staples with FEEs configured, for example, for deployment in a 6FR catheter may have an h of up to about 300 pm, and in some cases 225 pm or less. An exemplary embodiment that may be provided with a 6FR delivery system has one or more FEEs with an h of about 200 pm. Even larger staples with FEEs configured, for example, for delivery via an 8FR catheter could have an h of up to 950 pm, while in some embodiments FEEs of up to 500 pm could be provided. An exemplary embodiment that may be provided with an 8FR delivery system has one or more FEEs with an h of about 400 pm.

Each of the previous dimensions of h may be combined with a plurality of dimensions for W of the FEE. The dimension W would usually be the width of the strut, but could be only 50% of the strut width and in the FEE position may be between about 50% and about 100% of the width of the struts. I, and I a are a function of W, the radial force of the system, the topography of the lumen, and the delivery device, for example, varies as a balloon is used to force the device into the artery. If we consider only W (non-elastic system), then la can be approximately equal to the length of the strut. As the outward force increases (in terms of both the elastic nature of the metal and the balloon support), la may decrease and approach zero. However, in various embodiments la is at least about 20 pm.

The focal elevation elements may be formed as cylindrical, rectangular, linear, spherical, conical, teardrop, pyramidal or inclined elements on the annular periphery of the stapler device. They can be obtained by bending or punching a portion of the staple structure, by an addition process (such as by welding or tempering on a peripheral surface), by a subtraction process (such as by grinding away or etching surrounding material so that the bump element is higher than the surrounding area) by changing small areas of the peripheral surface so that they are higher than the surrounding surface before or after the sheet or pipe cutting. For example, a method of modifying small areas of a mesh staple structure by knotting, twisting, bending, or weaving small portions of the wire mesh so as to create raised elements from the mesh surface which then interface with the arterial wall of the staple devices.

Properly aligned and symmetrically positioned focal elevation elements can provide a focus for the force of expansion. While the device exerts outward forces and the artery inward forces, the focal lift elements can be placed in strategic positions in which the outward pressure of the strut sections adjacent to the focal lift elements is reduced.

Both anchors and focal elevation elements can provide strategic advantages including: reducing the compressive load across the staple struts by reducing the contact area and transmitting the outward forces to the anchors and focal elevators, thereby minimizing surface contact which causes a reduction in the tendency of the frictional charge caused by the micro-movement between the arterial wall and the staple strut, as well as the stabilization of the staple anchoring, where the anchoring and focal elevation element penetrate the vessel wall, at a fraction of the height of the features.

Because the stapler device is held in the desired position by its own outward force exerting it on the surface of the blood vessel, it may be susceptible to friction, i. H. a slight movement between the device and the vessel surface. FIG. Fig. 10 illustrates the forces acting between the focal elevation elements of the staple and the arterial wall. FT is the circumferential force acting on the staple device against the force of the arterial wall, FA. FFee is an additive peripheral force on the focal elevation element generated by the choice of structure and materials, and Ff is the frictional force of the artery that results when the artery changes its orientation or shape due to body forces. With every movement of a body part, the blood vessels move with something. The focal enhancement elements may be strategically positioned to reduce the local friction load that can cause inflammation, cell proliferation or a body reaction that leads to restenosis.

The number and positions of the focal elevation elements can affect the overall relative metal surface area (RMS), as previously explained. The focal elevation members may be disposed along the lengths of the stapler device surfaces such that a minimal metal surface area is in contact with the arterial wall. Focal elevation elements placed on bridges between circumferential strut rings or on the apices of the strut sections of the stapler device can provide much of the relief of arterial injury. When focal lift elements are placed only on the apices and bridges, the RMS of the strut members that make up the concentric ring changes only slightly, while the RMS of the bridges is reduced more significantly due to the narrow length, thereby relieving the relative movement of the bridges provided on the circumference aligned strut rings.

FIGS. FIGS. 11 and 12 illustrate the application of the focal lift members to a stapler of the type described above with reference to FIGS. 5A-C with two or more concentric ring sections connected by bridges therebetween. FIG. Figure 11 shows a cell of two adjacent ring sections 290a and 290b with strut sections 290c connected in the middle by bridges 290d. FIG. 12 shows the annular sections under which expansion force expands and opposite rows of focal lift elements 290e provided at opposite ends of the two adjacent ring sections 290a and 290b. A detail shows the round raised element with a raised height from the strut surface.

FIGS. Figures 13 and 14 illustrate a cell of another variant of focal elevation elements formed on a staple device having two or more concentric ring sections 300a, 300b connected by bridges 300d therebetween. In this cell variant, the focal lift members 300e are formed by bending the sections of the strut (shown as strut apex) from the circumferential plane to varying degrees of inclination, such as position "a" or position "b", to a vertical orientation of 90 degrees in position "c" to form the lifting element.

Inherent in the use of shape memory alloys for the staple devices is the ability to smoothly follow the shape of the blood vessel walls. Since expansion pressure can be applied to the blood vessel walls by the focal elevation elements, with minimal risk of injury, they can be designed to reshape the blood vessel walls to a desired shape. FIG. 15 illustrates the focal elevation elements (FEE) disposed in diametrically opposed positions and formed with an expanded height for reshaping the arterial walls into an elliptical cross-sectional shape that better suits the arterial cross-section (such as arterial branching) or for expanding the lumen. so that it is more open in plaque-free areas.

FIG. Fig. 16 shows a side view of the FEEs arranged along a strut length, having a small area raised off the artery, due to the height of the FEE which raises a short distance to the adjacent strut length. Outward forces generated by the structure or material used allow only a small portion of the blood vessel wall to be lifted on each side of the FEU.

FIG. Figure 17 illustrates a perspective view of a series of FEEs spaced along the length of a strut section of a stapler device. FIG. Figure 18 illustrates a detail view of a cylindrically shaped FEE positioned on the apex of a strut section of the stapler device. FIG. 19 illustrates a perspective view of a FEE formed as a pyramidal member on the apex of a strut portion. FIG. Figure 20 illustrates a perspective view of a FEE formed as a coupling element on the apex of a strut section. FIG. 21 illustrates a perspective view of a FEE formed by bending the apex of a strut portion upward. FIG. Fig. 22 illustrates a perspective view of a FEE formed by twisting a strut portion (made of wire).

IV. METHOD AND DEVICES FOR PROVIDING PLAQUE PACKS AND FOR FORMING INTRAVAS KU LAREN STRUCTURES IN SITU

A variety of delivery methodologies and devices can be used to provide plaque staples, some of which are described below. For example, a plaque staple may be provided by an endovascular introducer in the blood vessel. The delivery devices for the various embodiments may be different or the same, and may have features that are specifically designed to provide the particular staple. The plaque staple and installation method may be designed in a number of ways that share a common methodology of utilizing an expansive force of the delivery mechanism (such as a balloon expansion) and / or the expansive force of a compressible annular band to allow the staple to position itself in the blood vessel, and then released into an expanded state within the blood vessel, unfolded or turned back.

Referring back to FIGS. 4-4D, a delivery device or catheter 11 having an outer sheath 13 in a pre-deployment condition is illustrated. Multiple plaque staples 10 may be compressed so that they can be loaded onto the surface of the delivery device 11. The outer wrap 13 may then be advanced to cover the plaque staple 10 in preparation for deployment. In some embodiments, the plaque staples 10 are frozen in their compressed state to facilitate loading onto the delivery device. The staples may extend in an array equal to ten times a respective length of the delivery device.

It will be appreciated that the plaque staple 10 may be positioned by the delivery device 11 at the treatment site in the patient's trunk. The outer wrap 13 is retractable or retractable to expose and release the plaque staple 10. The staple 10 may then be expanded in any suitable manner, such as by the self-expansion configuration or balloon expansion, as described herein.

[00208] With reference now to FIGS. 23-31B, a method is described for providing one or more staples 10 ". As already mentioned, an angioplasty procedure or other type of surgery may be performed on a blood vessel 7. Angioplasty may be performed on a diseased or blocked part of blood vessel 7. As shown in FIGURE 23, a guidewire 40, followed by an angioplasty balloon catheter carrying the balloon 42, is advanced into a blood vessel 7, to a position containing a plaque-formed blockage, and the balloon 42 is inflated to the desired position To compress the plaque and dilate the vessel 7 (Figure 24), the balloon 42 may then be deflated and removed.

When dilating vessel 7, dissection 44 of the plaque can be effected by angioplasty (FIG. 25). Then, a plaque staple or staple 10 "may be used to fix the plaque dissection 44 to the lumen wall 7.

A delivery catheter 11 'pre-loaded with one or more staples 10 "may be advanced along the guide wire 40 to the treatment site (FIGURE 26) An outer sheath 13' may be withdrawn, thereby forming a portion of the plaque staple 10 "is exposed. As previously discussed, the outer sheath 13 'may be retracted to a desired point, then the position of the catheter within the vessel may be adjusted as necessary to ensure accurate placement of the plaque staple 10 "(FIG For example, set point may be just prior to exposure of any of the staples, prior to exposing a portion of the ring or the entire ring, prior to exposure of a ring and anchorage, and so forth.

The staple 10 "may then be released in the desired position in the lumen As previously stated, in some embodiments of the plaque staple 10", a simultaneous placement may occur upon release. Then, additional plaque staples 10 "may be placed as needed (Figure 28), and after placement of the second staple 10", an intravascular structure is formed in situ. Placement in situ may be in any suitable vessel, such as in any peripheral artery. The structure need not be limited to only two staples 10 ". In fact, a plurality of at least three intravascular staples 10" (or any of the other staples herein) may be provided in an intravascular structure formed in situ. In one embodiment, each of the plurality of staples has a length of not more than about 8 mm, for example, about 6 mm in an uncompressed state. In one configuration, at least one of, for example, all staples are spaced from an adjacent staple by at least about 4 mm. Although certain embodiments have a length of 8 mm or less, other embodiments may be longer, for example, up to 15 mm long. In addition, adjacent staples 10 'may be spaced as close as 2 mm, especially in vessels that are less susceptible to bending or other movements. In one embodiment, each of the staples has a relatively weak radial force, for example, a radial expansion force of not more than about 4 N, and in some cases about 1 N or less. In some embodiments, the staples may be configured with as little radial force as 0.25 N. In the various delivery devices described herein, the distances between the implanted staples can be controlled to maintain a desired or minimum clearance between each staple. It will be appreciated that the delivery devices and / or staples may include features that help maintain the desired spacing between the staples. Maintaining proper staple spacing can help ensure that the staples are distributed over a desired length without contacting each other or without accumulating in a particular area of the treated vessel. This can help to avoid kinking of the vessel in which they are arranged.

While a three-staple structure formed in situ may be suitable for certain indications, an intravascular structure with at least 5 intravascular staples may be useful for treating loose plaques, vascular valves, dissections, or other disorders that are significantly more elongate (non-focal) be advantageous. For example, while most dissections are focal (eg, axially short), a number of dissections may be considered and treated as a more elongated disease.

In some cases, even staples having a shorter axial length may be used to treat more widely spaced positions. For example, a plurality of staples, each no more than about 7 mm in length, can be placed in a vessel to treat a violent disease. At least some of, for example, all staples may be spaced from adjacent staples by at least about 5 mm. In some cases, gaps may preferably be provided between adjacent staples, which may range from about 6 mm to about 10 mm.

Optionally, after the plaque staples 10 "have been set, the angioplasty balloon may return to the treatment site and be inflated so as to expand the plaque staples 10" to the desired expansion state. FIG. Figure 29 shows the plaque staples 10 "in their final implanted state.

[00215] Referring to FIGS. 29, 30A and 30B it can be seen how the focal elevation members 32 can both penetrate the plaque in the blood vessel wall and minimize the contact surface of the plaque staple 10 "with the blood vessel wall." Likewise, Figs. 29, 31A and 31B illustrate the penetration of the anchors 20. It will also be appreciated that the position of the anchors 20 on the bridge 14 allow the anchors to protrude tangentially from the annular shape formed by the plaque staple 10 ". This advantageously allows the anchors 20 to hook into the plaque or vessel wall, and also minimizes the overall contact size through the plaque staple 10 ", much like the focal elevation members 32. A. Other Systems and Methods for Providing Plaque Staples [00216 FIGS. 32A-48D illustrate a system for providing a vascular prosthesis, such as any of the endovascular staples or plaque staples described above.FIGURE 32A shows a system 100 for the controlled delivery of a self-expanding staple can be used to improve the provided position of the staples as well as the provision of staples that are at least partially expanded by an outward radial force.

The system 100 includes a catheter assembly 104 and a fitting 108 to which the catheter assembly 104 may be coupled. The armature 108 may be a small configuration for manual operation, but in some embodiments is fixed to a larger object or otherwise configured to be immobilized. The catheter assembly 104 may be received by the fitting 108 and held therein in the desired position to limit or eliminate unwanted relative movement between the fitting and at least one component of the catheter assembly 104. For example, the fitting 108 may include one or more caps 112 that may be configured to hold a portion of the catheter assembly 104. FIG. 32A shows that the fitting 108 in one embodiment includes proximal and distal caps 112A, 112B, which will be discussed in more detail below. The caps 112A, 112B may be removed to allow the catheter assembly 104 to be placed in the fitting 108 by the clinician or already attached to the catheter assembly upon delivery. The features of the fitting 108 can be compared with those of the figures of FIGS. 46-48D combine or expand on those which describe further details of the delivery systems that may be located at the proximal end.

The catheter assembly 104 includes an elongate body 132, a sheath 136, and a plurality of intravascular staples 140. Although a staple 140 is shown in FIGS. 32B and 33B, a plurality of other staples may be disposed within the catheter assembly 104 as discussed below in connection with FIG. 36A explains.

[00219] FIGS. 36-36A show that the elongated body 132 has a proximal end 152, a distal end 156, and a plurality of delivery platforms 160 disposed adjacent the distal end. Each of the delivery platforms 160 includes a recess 164 that extends distally from an annular marker band 168 (FIG. 33B). The annular marker band 168 has a larger outer diameter compared to the recess 164. In some embodiments, the recess 164 may be defined as the smaller diameter portion adjacent or between one or two annular marker bands 168 and / or another feature on the elongated body 132. The platforms 160 are shown schematically in FIGS. 32A-33B and shown in greater detail in FIG. 36A. In embodiments with a plurality of staples 140, a plurality of corresponding delivery platforms 160 are provided. Any number of staples and platforms may be provided, such as four staples and platforms, two or more staples and platforms, between three and twenty staples and platforms, or other configurations. Each delivery platform 160 includes at least one marker band 168. For example, a proximal marker band 168A and a distal marker band 168B may be provided to visualize the ends of the platform 160 using standard visualization techniques. In the illustrated embodiment, the proximal marker band 168A of a first platform 160 is also the distal marker band of the platform that is positioned directly distally.

The annular marker bands 168 may take any suitable form, such as including one or more of tantalum, iridium, and platinum. In a particular arrangement (see FIG. 36A), the most proximal marker band 168A comprises tantalum while the distal marker bands 168B comprise one or more of the platinum and iridium materials. The use of various materials to achieve radiopacity may be based on the cost or preference for better visibility and / or thinner structure. Platinum / iridium offers better radiopacity than tantalum, which makes the distal marker bands thinner or more visible than the tantalum band.

[00221] The ability to enhance radiopacity, which allows the physician fluoroscopic visibility, may be provided in various ways on the delivery device and staple. An example is the inclusion of thicker material areas (either wider in circumference or radially thicker).

In addition, the annular marker bands 168 have a radial height which is the radial distance to the top of the band from the base of the recess 164. The radial distance may vary, but is preferably just high enough to prevent the staple 140 from getting caught between the elongated body 132 at the annular marker band 168 and the sheath 136. In certain embodiments, the radial distance is approximately equal to at least the thickness of the staples 140 disposed in the catheter assembly 104.

In another embodiment, the delivery platforms 160 are located distally of a proximal marker band 168A where the marker bands are frusto-conical such that the proximal end of each marker band has a radius nearly equal to the radius of the elongate body 132 while the radius of the marker band Marker band at the distal end is a reduced radius. In some embodiments, the reduced radius may be the original radius, as discussed above. In other words, the marker band tilts proximally upwards, toward the nearest proximal staple. As a result, a wall is created at the proximal end of the marker band 168A. A distal end of a staple after its provision is placed against the wall, thus the marker band can aid in the proper placement of the staple. In addition, the sloped surface may be helpful to facilitate the smooth retraction of the sheath from the elongate member before the staple is provided. For example, the sloped surface may limit the ability of the staple to snag on a marker band after deployment while the sheath is being withdrawn. In some cases, the staple may have a strut portion that does not completely face the wall; the inclined marker band may limit the ability of the marker band to grasp this raised strut portion upon retraction of the sheath. In this arrangement, the distal portion of the staple rests in the delivery platform just proximal to the tip end of the proximal marker band in the delivery system 100, as opposed to directly against the wall with the inadequate marker band.

In another embodiment, the marker bands may be frusto-conically in the opposite direction, in which the radius is greatest near a distal end and then tilts down proximally. In this embodiment, the marker band has a wall at the distal end. The sloped surface may be helpful to facilitate the smooth retraction of the extended portion after the staple has been provided. For example, the sloped surface may limit the ability of the staple to hook onto a marker band after deployment while the elongate member is withdrawn from the vessel. In one variation, the delivery platform may be truncated in one or more directions.

The marker bands may be frusto-conical in one or more directions. The truncated cone-like segment of the marker band can be formed by adhesive, which can fix the marker band to the elongated part. The adhesive may form a bonding layer between the marker tape and the elongate member. The tie layer may have a concave, substantially planar or convex outer surface. In some embodiments, the marker band may have tie layers on both sides and with different outer surfaces. For example, the marker band may have a concave tie layer at the distal end and a tie layer at the proximal end that has a substantially planar outer surface or an outer surface that is less concave than the distal tie layer.

In some variations, the staples 140 are completely self-expanding. In other variations, at least one of the delivery platforms 160 includes an expandable portion so as to expand a staple disposed thereon. The expandable part may be a standard structure, as for balloon angioplasty, or a special design as shown in FIG. 45. The staples 140 may also be provided by special balloons coated with drugs to minimize restenosis, inflammation or other side effects of treatment with a plaque staple.

The elongated body 132 includes a distal tip 172 that tapers to facilitate easy insertion, and a lumen 176 that extends proximally therefrom to the proximal end 152. As already mentioned above in connection with FIGS. 4-4D and the FIGS. 23-31, the lumen 176 may be used to guide the distal end of the catheter assembly 104 into a treatment area. The proximal end 152 may have any suitable shape, but is preferably configured to snap-lock to the fitting 108. FIG. For example, FIG. 36 shows that the proximal end 152 may include a luer hub 178 with flanges that may be received within a similarly shaped recess in the fitting 108. For example, a recess corresponding at least in part to the shape of hub 178 may be formed between a base 110 of the fitting 104 and the cap 112A. When the elongated body is received in the fitting 104, the hub 178 between the cap 112A and the base 110 can be received in this recess and secured by a secure connection of the cap 112 with the

Base 110 so as to prevent unwanted movement of the elongate body 132 relative to the enclosure 136 and to reduce or prevent movement relative to a fixed reference frame, such as the reference frame of the armature 104.

The sheath 136 has a proximal end 192, a distal end 198, and an elongate body 200 extending therebetween. The sheath 136 is movable relative to the elongate body 132 from a first position to a second position.

The enclosure may be formed from a hypotube, such as a metal or plastic hypotube. The flexibility and stiffness of the sheath can be controlled with many features, such as the inclination and frequency of a spiral cut along the length of the hypotube.

[00230] FIGS. FIGS. 32A-32B illustrate a first position in which the distal end 198 of the sheath 136 is located distal from a distal distal delivery platform 160. In FIG. 32B, the most distal platform is occupied by a staple 140. Another platform, directly proximal to the occupied platform, is shown without a staple for clarity, but may be occupied by another staple. Other platforms and staples may be located further proximal. FIGS. 33A-33B illustrate a second position in which the distal end 198 of the sheath 136 is disposed proximal to at least one delivery platform 160.

The sheath 136 may also include a crotch luer 204 having a main arm for receiving the elongated body 132 and a side arm 206 disposed at the proximal end of the elongated body 200. The side arm 206 includes a purge port that is used to purge air and to increase lubricity in the space between the enclosure and elongate body 132. A Tuohy-Borst adapter 208 (or other seal assembly) may be provided proximal to the crotch luer 204 to receive the distal end of the elongated body 132 prior to application to a patient (eg, during fabrication). In some embodiments, a strain relief collar 212 is provided between the crotch luer 204 and the elongated body 200 to make the joint more robust. The strain relief collar 212 may take any shape, for example, it may be made of polyolefin or a similar material.

In one method of use, the distal end of the catheter assembly 104 is inserted into the patient and the proximal end is placed in the fitting 108. The sheath 136 is in a distal position, such as with the crotch luer 204 at the front, in the fitting 108. During the procedure, the sheath 136 is progressively moved toward the proximal position, such as to a proximal portion of the Tuohy Borst Adapter 208 a distal portion of the cap 112 A of the fitting 108 touches. As the sheath 136 is moved proximally, the staples are provided, either one at a time, while the clinicians reposition the elongate body 132 after each deployment or deployment row, or all at once, without repositioning the elongated body 132.

The armature 108 advantageously aids in the placement of a plurality of staples 140 in a treatment area in spaced positions, as shown in FIG. 29 shown. For example, the armature 108 reduces inadvertent relative movement between the sheath 136 and the elongated body 132. When the armature 108 is immobilized, the armature helps limit the movement of the elongated body 132 by internal frictional engagement on the sheath 136 during the crotch -Luer 204 is moved proximally. This may result in a more controlled deployment than if the clinician would need to hold both the proximal ends of the elongate body 132 and the sheath 136 directly. This helps ensure that a minimal gap in the treatment area is provided between the distal end of a proximal staple and a proximal end of a distal staple. The gap is shown in FIG. The gap advantageously minimizes the likelihood of two staples jamming in the vessel or other discomfort caused by too close proximity, thus allowing the gap or spacing between the staples to be controlled In other embodiments, the distance between the staples may be controlled to be between 5mm and about 14mm. In other embodiments, the distance between the staples may be controlled to be between about 5mm and about 20mm Staples are controlled so that it is between 6 mm and 12 mm.

In addition, this arrangement allows the placement of two or more staples without having to move the delivery platforms 160 between the deployments of the staples 140. Instead, the delivery platforms 160 may be positioned and held in the desired position prior to providing a first staple 140. After providing the first staple 140, the delivery platforms 160 may be held in position and the wrap 136 may be withdrawn to release and provide a second staple 140, a third staple 140 or more.

The system 100 offers the further advantage of precise placement of multiple vascular prostheses after the catheter assembly 104 is placed in the patient. The catheter unit 104 does not have to be withdrawn, in particular after the placement, and exchanged for other catheters or catheter systems in order to be able to carry out further treatments. In this regard, the system 100 may be used for endovascular staples or staples as well as for stents and other vascular devices that are spaced in different areas of treatment in the body of the patient. 1. Minimizing Movement with Distal Anchoring In certain endovascular prostheses, precise placement at a treatment site or in a treatment area is important, for example, when the prosthesis is relatively short, as when it is over a ratio of axial length to transverse width (for example, the diameter) of 1 or less, or if the placement is via a tortuous path (for example, an arterial bend). Stabilization at a proximal end, such as fitting 108, can provide reliable placement, but stabilization closer to the prosthesis can provide even greater accuracy with respect to axial position and minimize inclination of the device within the vessel. In this context, the inclination includes any non-perpendicularity of a transverse aspect of the device to the lumen in which it is provided. For staple 10 ', a transverse aspect may be defined by a plane intersecting the high outer apices 24. A tendency for relatively short prostheses can reduce the stability thereof. Tilting the staple 10 'may rotate the anchors 20 out of optimal alignment to fix plaque, thereby reducing, for example, their effectiveness. a. Minimizing Movement with an Actively Expandable Distal Anchoring Figures 37A and 37B illustrate a delivery system 100A which is a variation of the delivery device 100 but has a distal portion thereof configured to stabilize the system in the vasculature, to allow even more accurate placement of two or more staples. In particular, the system 100A includes a stabilizer 250 disposed on an outer surface of the system, such as an outer surface of an elongate body 132A. The stabilizer 250 may be adapted to anchor directly into a body lumen. In some embodiments, the stabilizer 250 is adapted to anchor at a plurality of locations around the lumen, e.g. B. at discrete points or on a continuous perimeter or on a contact surface. Such anchoring may advantageously minimize movement of the elongated body 132A relative to the body lumen when relative movement between

Enclosure 136 and the elongate body 132A is provided. For example, the stabilizer 250 may maximize radial centering during the movement of the enclosure 136, advantageously allowing a gap between adjacent staples provided by the system 100A to be controlled.

The stabilizer 250 may maximize radial centering during the movement of the enclosure 136 so as to locate the center of the elongate body 132 on the most distal delivery platform 160 within about 50% of the radius of the vessel in which the platform which advantageously allows the inclination of each staple provided by the system 100A to be controlled. In certain embodiments, the stabilizer 250 maintains the center of the elongated body 132 at the most distal delivery platform 160 within about 40% of the radius of the vessel in which the delivery platform is located. In another embodiment, the stabilizer 250 holds the center of the elongated body 132 at the distalmost platform 160 within about 30%, about 20%, or about 15% of the radius of the vessel in which the delivery platform is located. The radial displacement may include transverse motion within a body lumen or angulation within a vascular segment. For example, due to the tortuosity or bending of a blood vessel, the distal portion of system 100A may have a varying distance from the vessel wall along its distal length. In side view, the elongated body 200 of the enclosure 136 forms an angle with the central longitudinal axis of the vessel. Thus, one side of the elongated body 132A is closer to the vessel wall than the other, and the distance varies along the length of the staple 140. This may cause one of the proximal or distal ends of the staple 140 to snap into place in the vessel first, causing the staple in the vessel tips over. The stabilizer 250 may bring a distal segment of the system 100A closer to the coaxial with the longitudinal axis of the vessel. For example, the stabilizer may be configured to maintain the longitudinal axis of the elongate body 132A within at least 4 delivery platforms within 20 degrees of the longitudinal axis of the vessel. In some embodiments, the stabilizer 250 may be configured so that the longitudinal axis of the elongated body 132A is held within at least 10 degrees of the longitudinal axis of the vessel for at least 10 meters. In some embodiments, the stabilizer 250 may be configured such that a transverse aspect of the staple 140 is within 10 degrees perpendicular to the longitudinal axis of the blood vessel.

The stabilizer 250 may be configured to reduce or minimize the axial displacement. The apparatus 250 may reduce or minimize the movement of one or more delivery platforms 160 along the lumen of a vessel in which the platform is disposed, so as to enhance control over delivery. The stabilizer 250 may maintain the axial position of a distally facing surface of an annular marker band 168 within about 15%, 20%, 30%, 40%, or 50% of a delivery platform length. The delivery platform length may be measured parallel to the longitudinal axis of the elongated body 132 between a distal facing surface of a proximal marker band 168A located at the proximal end of the delivery platform and a proximal facing surface of a distal marker band 168B located at the distal end of the same delivery platform. In some applications, the axial displacement for at least the second and subsequent staples provided is reduced or minimized, for example, to assist in maintaining spacing between the staples, as discussed elsewhere herein. The stabilizer 250 may also be configured so that any offset in the position of a first or subsequent staple that is provided is reduced or minimized as compared to a planned implant site. The intended implant site is the absolute location in a vessel in which a clinician wishes to place the staple, this may be based on visualization techniques, such as fluoroscopy or other surgical planning method.

The stabilizer 250 may include an inflatable balloon 254 that may take any suitable shape. For example, the balloon 254 may be cylindrical as shown in FIGS. 37A-37, or conical. An advantage of a conically shaped balloon is that the dilation function provided by the conical tip 172 can be performed by the leading edge of the conical balloon, thus these structures can be combined in some embodiments. Or, if the anatomy is not cylindrical, a properly shaped balloon, such as a conical balloon, could be adapted to the shape of the anatomy to provide better apposition.

In the illustrated embodiment, a cylindrical balloon 254 is disposed proximal to the distal tip 172. The stabilizer 250 may be disposed between the distal end of the elongate body 132A and at least one of the delivery platforms 160. The balloon 254 is configured to minimize at least one axial or radial displacement of at least one of the delivery platforms 160 along a longitudinal axis of a blood vessel in which staples or other vascular prostheses are to be provided or away.

The balloon 254 may be inflated by any suitable means, such as through the flow of an inflation agent through a lumen in the elongate body 132 from the proximal end thereof to an inflation port in the balloon 254. The elongate body 132 for the system 100A may be dual Lumensextrusion be formed, with a lumen for the guide wire and the other lumen for inflating the balloon 254 is used. The inflation lumen may be connectable to a syringe or other vacuum source at the proximal end of the elongate body 132 so as to provide the inflation means. The balloon 254 has a flat configuration prior to inflation, allowing it to rest on the elongated body 132 without obstructing deployment of the distal portion of system 100A. For example, the balloon 254 may be disposed within the enclosure 136 (eg, between an interior surface of the enclosure 136 and the lumen 176) prior to being inflated. In another embodiment, the balloon is disposed longitudinally between the sheath 136 and the tip 172. In this embodiment, it may be advantageous for the balloon to act as a tip, with the distal end being conical to allow navigation in the vessel, while the proximal end of the balloon has the same width (eg, radius) as the sheath 136, so as to provide a smooth transition between the two to avoid any protrusion at the interface between the balloon and the distal end of the sheath 136.

The use of the balloon 254 offers the clinician the ability to first place and inflate the balloon distal to the lesion. After the balloon is then anchored in the wall of the vessel, the enclosure 136 is withdrawn and exposes one or more staples 140, allowing the staples to be released at previously defined separate locations. The separate locations are predefined as they match the previously made separations of the staples in the delivery system 100A.

An advantage of balloon 254 is the additional function that the balloon can be used for post-dilatation of the staples after placement. In this case, after placing the staples in the vessel within a provided staple 140, the balloon 254 may be repositioned and re-inflated, anchoring the staple by outward pressure from the expanding balloon so as to improve the placement of the staple in the vessel wall ,

Figure 38 illustrates one of several embodiments where a proximal control is provided to actuate a connection to move one or more distal components of a delivery system to effect radial expansion for latching anchoring in a vessel wall. In particular, the system 100B includes a stabilizer 250A that is configured to be actively expanded from a flat configuration to an expanded configuration. The flat configuration is such that it is suitable for advancement through the vessel structure. The shallow configuration allows the sheath 136 to be advanced over the stabilizer 250A without the sheath 136 having to be radially expanded.

The stabilizer 250A includes a stabilizing member 270 disposed adjacent to the distal end of an elongate body 132A. The elongated body 132B has a plurality of delivery platforms 160 proximal to the stabilizer 270 and is similar to the elongate body 132, except as described below. In the illustrated embodiment, the stabilizer member 270 includes a plurality of elongate, axially disposed strips 274 that are separated by slots 278. The strips are sufficiently flexible so that they can expand radially as compression forces are applied to the proximal and distal ends thereof. The radial expansion of the strips 274 causes the outer surfaces thereof to anchor at circumferentially spaced locations in the wall of the lumen.

The stabilizer 250A further includes a joint 282 and an actuating mechanism configured to apply a compressive force to the stabilizer 270 (shown by the arrows in FIG. 38). The connection 282 may be a wire having a distal end coupled to the tip 172 and a proximal end coupled to the actuation mechanism. The actuating mechanism may be incorporated into the delivery system 500 of FIG. 46, as discussed in more detail below, or any of the other delivery systems or any of the other delivery devices described herein.

Compound 282 may be eliminated by providing a balloon or other actively expandable member within stabilizing member 270 such that the operator may actuate the balloon to expand the elongated axially disposed tabs 274 into an anchorage to the vessel wall. The strips 274 preferably define gaps therebetween through which at least some blood may flow downstream of the stabilizing element 270. This can avoid ischemia in one procedure compared to other anchoring elements that are more occlusive.

An imaging device 286, such as a radiopaque band, may be positioned proximal to the stabilizing element 270, for example, between the stabilizing element 270 and the most distal delivery platform 160 so as to indicate to the clinician that the stabilizing element 270 is distal to the lesion or to the treatment area. b. Minimizing Motion with a Passively Expandable Distal Anchoring Passive anchoring members may be used in addition to or as an alternative to actively actuated anchors to provide stabilization of a delivery system. Passive anchoring elements may be disposed on an outer surface of the delivery system so as to minimize at least one of the axial or radial displacement of at least one of the delivery platforms.

The structure of FIG. 38 can also be used in a distal anchoring arrangement for passive deployment. The stabilizing element 270 may comprise, for example, a shape memory material. In one embodiment, the elongated, axially aligned strips 274 are formed from a shape memory material and configured to be in a radially enlarged state in the absence of a circumferential restriction. This variation is provided adjacent to or at a location that is in a restricted state distal to a lesion or treatment area, such as enclosure 136 over elongate, axially-aligned strip 274. The relative movement between enclosure 136 and the elongated one Part 132B exposes the elongated, axially aligned strips 274 and allows the strip to return to its radially expanded configuration. This embodiment advantageously eliminates the need for a connection 282.

FIGS. FIGS. 39-40 illustrate two passively provided anchors that may be used in a deployment system 100C. The dispensing system 100C is the same as the dispensing system 100, except for certain modifications to the elongated body 132. In particular, an elongate body 132 is provided on which a self-expanding portion 300 is disposed. In FIG. 39, the self-expanding portion 300 includes a braid structure 304 having proximal and distal ends 308A, 308B connected to a portion of the elongated body 132C between the distal most delivery platform 160 and the distal tip 172 Enclosure 136 is supplied and provided by the provision of relative movement between the enclosure 136 and the elongated body 132C. The braid structure 304 has an expanded width in the absence of any perimeter restriction that is greater than the size of the vessel in which the system 100C is to be provided. As a result, passive expansion or self-expansion of the braid structure 304 creates anchoring in the vessel wall. Thereafter, one or more staples 140 may be provided in a precise and controlled manner.

The braid structure 304 has the further advantage of allowing blood flow therethrough to maintain at least some perfusion of tissues downstream of the anchoring site. With respect to other more or fully occlusive anchors herein, lumens may be provided as an alternative means of maintaining perfusion.

For example, when a balloon is used to anchor a delivery system, a lumen may be provided by the balloon to perfuse the tissues downstream. Rapid intervention may not require perfusion.

FIG. FIG. 40 illustrates the self-expanding part 300 as including a plurality of axially extending arms 320. Each arm 320 has a proximal end 324 coupled to the elongate body 132D and a distal end 328. The elongated body 132D is shown without the tip 172, but the tip may be provided as in any of the embodiments above. Each of the arms 320 is configured to be supported by the sheath 136 in a flat configuration in which the distal end 328 of the arms 320 is adjacent to the elongate body 132D and extends radially away from the elongate body 132D when the sheath 136 is disposed proximal to the arms 320. In the expanded position or configuration as shown in FIG. 40, the distal ends of the arms are positioned so as to apposition a body lumen. There may be any number of arms provided. The arms 320 act similar to a tripod for stabilizing and positioning (e.g., centering) the elongate body 132D distal to the delivery platforms 160.

FIG. Figure 41 illustrates another form of passive anchoring which involves improving the isolation of the delivery system 100 of friction that may result from anchoring the system in the vasculature. This friction increases significantly as the catheter assembly 104 traverses any turns in the vasculature. One method of isolating the system 100 from friction is to provide a friction isolation sheath 340 disposed between the sheath 136 and the vasculature. The friction isolation sheath 340 may take any suitable form, but is preferably configured to prevent frictional forces along the outer surface of the sheath 136 from causing undesired movement of the elongate body 132 during placement of the staples 140.

One method of isolating the wrapper friction wrap 136 is to configure the friction isolating wrapper 340 to have a length sufficient to extend from the vascular access site A, such as a femoral artery, to the treatment area. FIG. Figure 41 illustrates that the treatment area Z may run across the pelvic crotch B and into or distal to the iliac artery of the leg through which the vascular access has not been laid. In other words, the distal end 344 of the friction isolation sheath 340 is disposed beyond the bifurcation B or another turn T is. Other treatment areas may be achieved using the friction isolation sheath 340. The length could be sufficient to extend distally to each further turn below the iliac artery into the leg with access or without access. In other words, the distal end 344 of the friction isolation sheath 340 is located beyond the arc or other turn. In some approaches, the friction isolation wrapper could be configured with improved lubricity on an interior surface thereof. The improved lubricity would reduce the frictional forces below a threshold so as to eliminate unwanted movement of the elongate body 132 due to this friction. 2. Spacing Maintaining Policies and Methods Staples and other vascular devices that benefit from maintaining a predetermined minimum clearance may be provided with the system 100, as discussed above. Once stabilized, for example, using one of the methods described herein, for example, a minimum distance can be provided by a variety of structures. The delivery platforms 160 may, for example, help to manage fixture distances as needed. In some embodiments, the proximal marker bands 168 each project radially away from the elongate body 132 to an extent sufficient to present a distally directed shoulder that can abut a staple 140 disposed on the delivery platform 160. The shoulder may act like a piston and provide a holding or pushing force against a proximal aspect of the staple 140. This holding or pushing force may prevent proximal migration of the staple 140 while the sheath 136 is moved proximally relative to the elongated body 132.

FIG. Fig. 42 illustrates other embodiments in which a delivery system 400 adapted for providing a vascular prosthesis incorporating a plurality of discrete devices is provided. The system 400 includes an elongate body 404, an elongated package 408, and a wrapper 412. The elongated body 404 includes a distal end 414, a proximal end (not shown), and a piston 416 disposed adjacent the distal end 414. The elongated package 408 has a plurality of intravascular staples 140 coupled thereto. The staples 140 are disposed along the length of the elongated package 408.

The sheath 412 has a proximal end (not shown) and a distal end 420 and may be positioned in a first position where the distal end 420 of the sheath 412 is distal to at least a portion of the elongate packet 408. The first position may be one in which the entirety of the package 408 is disposed inside the enclosure 412. The distal end 424 of the package 408 may be disposed, for example, in and at or proximal to the distal end of the sheath 412. The sheath 412 may be positioned in a second position in which the distal end 420 of the sheath 412 is proximal to the elongate packet 408. The second position may be achieved from the first position by proximal movement of the sheath 412 relative to the piston 416, by distal movement of the piston 416 relative to the sheath 412, or by simultaneous proximal movement of the sheath 420 and distal movement of the piston 416 The piston is moved or held stationary by exerting a force on the proximal end of the elongated body 404.

The elongate package 408 is configured to maintain a minimum distance between adjacent staples during deployment, such as during any movement of components of the system 400, such as those described above. The elongate package 408 is also configured to allow expansion from a compressed configuration in which the elongate package 408 in the wrapper 412 is received. In an expanded state, the elongated package 408 may anchor in a vessel wall.

In various embodiments, the elongate package 408 may be configured to release the staples so that they may expand towards a vessel after deployment. The package 408 may be configured with an elongate collar 428 and a drawstring 432. The drawstring 432 is preferably coupled to the cuff 428 such that the separation of the drawstring 432 from the cuff 428 allows the staples 140 to expand toward a vessel wall. FIG. Figure 43 illustrates an embodiment of the cuff 428 that includes a weave structure 436 that may have a large weaving angle. For example, weave angles of at least about 110 degrees may be used. In this embodiment, the drawstring 432 may be configured as a severing string or a plurality of severing strings. The pull cord 432 may be actuated to release the retention force of the cuff 428. For example, in the woven embodiments, the pull cord 432 causes the cuff to separate to release the staples 140.

The pull cord 432 would preferably have a proximal portion coupled to an actuator at the proximal end of the corresponding delivery device. The pull cord 432 could pass through a lumen (eg, a dedicated lumen) in the delivery system, and be operable separately from an enclosure or plunger, if provided. The clinician would use this actuator to apply a force to the pull cord 432, thereby severing the weave structure or otherwise providing the staples 140.

Another embodiment may be provided in which the drawstring is eliminated. For example, cuff 428 may include a structure that is weakened when submerged in blood so as to passively release staples 140 shortly after deployment. The cuff 428 could comprise a bioabsorbable material or a non-reactive polymer left between the staples 140 and the vasculature. The entire structure provided, including the staples 140 and the cuff 428, could be configured to be absorbed into the vasculature in some applications and thus gradually disappear into the patient. In other embodiments, the elongate package 408 may be coated with a drug elution, such as the bioabsorbable means of the pull cord 432 and the cuff 428, which remain for elution from the staples. As the drawstring 432 is absorbed, the remaining pack 408 is pressed against the vessel wall by the expanding staples and remains there. In this alternative, pull cord 432 may simply be just a portion of (or one or a plurality of threads of) weave structure 436 and no otherwise salient structure of structure 436.

In an embodiment of FIG. 44, the elongated package 408 includes a plurality of staples 140 and a portion 440 extending axially through a central portion of each of the staples. The member 440 is connected to each of the staples 140 to retain the staples in a flat configuration in which the staple may be disposed in the sheath 136. FIG. FIG. 44 shows a plurality of staples 140 after they are separated from the elongated member 440 and expanded into the anchorage with the wall of vessel V. FIG. The elongate member 440 may be connected to the staples 140 in any suitable manner, such as by inserting a radially extending portion 448 or a plurality thereof. The parts 448 are configured to restrain expansion of the staples 140 while the staples are disposed in this wrap 136, but break after being provided therefrom. Breakage of the radial portions 448 may be achieved by any active mechanism, such as by cutting, untying or pulling a pull cord, or by a passive mechanism such as erosion in the vasculature. After the radial portion 448 is separated from the staples 140, the staples may move from the portion 448 into a radially expanded configuration, providing a gap between the portions 448 and the staples 140.

The portion 440 may then be moved out of the enclosure 136 by providing relative movement between the portion 404 and the enclosure 136. In the illustrated

Embodiment, the distal end of the elongate member 404 is connected to the proximal end of the member 440 and acts as a piston to push the package 408 out of the enclosure 136. In other embodiments, the elongate member 404 has a distal end that is small enough to be inserted through the staples 140 when the staples are in the flat profile configuration. The elongate member 404 may be coupled to the distal end of the portion 440 of the elongated package 408. In this arrangement, the elongate member 404 functions at the distal end of the package 408 rather than at the proximal end, as in the embodiments of FIGS. 42-43.

[00267] In each of the embodiments of FIGS. 42-44, a predefined and substantially fixed axial spacing is maintained between adjacent staples. Thus, the elongate package provides a device spacing member capable of providing precise separation between the staples during placement. This provides advantages such as minimizing kinking of the vessel, excessive metal and other problems associated with placing the staples 140 and other vascular prostheses too close together. 3. Balloon Expansion A balloon may also be used to provide a plurality of staples in a controlled manner to have the proper spacing therebetween. FIG. Figure 45 illustrates a delivery system balloon 490 to which a staple 140 is crimped. The illustrated portion of the staple 140 is one of a plurality of repeating segments having mirror image counterparts as described above, with other segments eliminated for clarity. The balloon 490 serves to provide and expand the staple 140 and may be referred to as a carrier balloon. The balloon 490 may be shaped or may include more than one plasticity allowing for controlled inflation. The staple 140 and the balloon 490 are transported to the repair site within a wrapper (not shown, but analogous to those discussed above). During deployment, the balloon 490 is expanded while or after leaving the distal end of the sheath. The expansion of balloon 490 expands the staple 140. In one embodiment of this system, the balloon is used to provide a staple 140 that may not be self-expanding or partially self-expanding. For example, the balloon 490 may be expanded to a threshold at which it breaks open a containment structure disposed between the staple 140 and a wrapper. Breakage of the retention structure allows the staple 140 to expand. The balloon 490 can fully expand the staple 140 (and, using the protrusions in the balloon 494, as discussed in more detail below, lift portions of the staple for more effective anchoring), release the staple 140 for self-expanding, or provide a combination of balloon and self-expansion ,

Another method for controlled placement of a staple 140 is to expand the staple under radially outward pressure, such as by expanding a balloon. FIG. Figure 45 illustrates the balloon 490 in an expanded state with a plaque staple 140 disposed thereon. Although a single balloon is illustrated, in one embodiment, a balloon is implemented in each of the delivery platforms 160 of the delivery system 100. The balloon 490 may take any suitable configuration, but is preferably configured to rotate the anchorages of staple 140 into a plaque or other vascular anomaly to hold it against a vessel wall. For example, balloon 490 may include a radial protrusion region 494 disposed in an expandable region thereof. The radial protrusion area 494 is preferably configured so that the anchor 20 of the staple 140 (see the anchors 20 in FIG. 5C) rotates outside of a cylindrical plane containing proximal and distal portions of the staple.

The protrusion region 494 may have any suitable configuration, such as a plurality of discrete protrusions circumferentially disposed about the balloon 490. The protrusions may be positioned to be below the anchors 20 of the staples 140, but not completely under the markers 22. The protrusions may be configured such that as the balloon 490 expands, the protrusions expand more so that the staple 140 may be deformed from a generally cylindrical deployment shape into an assembly in which the bridges 14 rotate about an axis, which connects the endpoints of the bridges. The rotation causes the anchors 20 to be tilted away from the center of the blood vessel and into the plaque to be attached.

In other embodiments, the protrusion area 494 may be a substantially continuous perimeter structure, such as a ridge that extends completely around the balloon. In this arrangement, there is preferably a greater radial protrusion of the balloon in the expanded state at the location radially between the anchors 20 and the longitudinal axis of the balloon.

The protrusion area 494 is preferably at least about 0.05 mm high. In other words, the protrusion region 494 has a radially outermost tip that is at least about 0.05 mm from the average surface of the balloon 490 when the balloon is expanded to the diameter of the vessel, in which the staple should be placed. Or, if a plurality of protrusions are provided, a cylinder which intersects the apices of all protrusions is preferably radially greater than the average radius of the balloon by about 0.05 mm. In other embodiments, the protrusion region 494 is between about 0.05 mm and about 0.4 mm high. While in other embodiments, the protrusion region 494 is between about 0.07 mm and about 0.4 mm high. In still other embodiments, the protrusion region 494 is between about 0.1 mm and about 0.2 mm high. The balloon 490 may advantageously be coupled to a staple that is not self-expanding. Deformable standard stent materials, such as stainless steel, can be used. In some cases, it may be advantageous to combine a balloon expansion stage with a self-expanding device. Thus, the balloon 490 can also be used in combination with self-expanding staples. The added height of the protrusion area 494 may advantageously activate a function of a staple 140 (such as an anchor 20 or a bridge 14) to prevent the staple from slipping along the axis of the balloon. In a typical balloon, a length that is not surrounded by a prosthesis expands more than a length that is surrounded by a prosthesis, creating a "dogbone" shape upon expansion. A balloon in the form of a dog bone could involve unwanted movement of the staples placed thereon. The protrusion area 494 can prevent this movement by anchoring the staple as described above. The balloon 490 may be configured to elute a drug that is beneficial for treatment, such as one that helps to minimize restenosis or an inflammatory response.

A balloon 490 may also include a number of restrictions, such as retention bands 492, which restrict the expansion of the balloon to certain areas of the balloon, as shown in FIG. 45A. For example, balloon 490 may be used with a series of non-self-expanding staples 140 disposed along the length of balloon 490. Fig. 45A illustrates a part of this balloon. Since balloons have a tendency to expand from one end, the restraint straps may restrict this type of expansion and focus expansion in each region containing a staple 140. Segments 494 of the balloon that do not include a staple or a retention band may be used to ensure proper spacing between the staples and may form a barrier between successive staples as the balloon expands to its fully expanded position. 4. Provisioning Systems As described above in connection with FIGS. 4A, 32A and 33A, a variety of tools and components may be provided for the proximal end of the delivery system 100. FIGS. FIGS. 46-48D illustrate further details of these and other embodiments of a delivery system 500 for the delivery system 100. The delivery system 500 preferably includes a housing 504 that can be held by the user and that includes a deployment device 508. The housing 504 is connected to the proximal end of the catheter assembly 104, for example, it is connected to the elongate body 132 and the sheath 136 (see FIG. 34) to initiate relative movement between these two components. In certain embodiments, it is preferred that the elongate body 132 is stationary and that the sheath 136 is retracted to provide relative movement. But in other circumstances, this may be reversed, such that the elongate body 132 is set in motion with stationary wrap 136.

In one embodiment, the housing and trigger 504, 508 include a single deployment ratchet assembly that is manually operated. In this arrangement, each time the trigger 508 is activated, relative proximal movement of the sheath 136 releases a prosthesis (eg, prosthesis 140). The trigger 508 would preferably be spring actuated so that it would spring back to its original position upon actuation. a. Electronically Assisted Delivery Devices As discussed above, a variety of indications are preferably treated with a plurality of discrete prostheses. For some treatments, the treatment site is remote from the site where the delivery system enters the vascular trunk or body lumen system. Both states may increase the amount of force required to actuate the trigger 508. For such conditions, and also to facilitate provision, the delivery system may include a mechanical energy source 516 to generate a force required to provide relative movement of the enclosure 136 relative to the elongated body 132. The power source 516 may be configured to produce approximately the same force at the distal end of the system 100 to provide a staple 140 or to provide a plurality of staples 140. The power source 516 may be configured to generate a force that is constant over a stroke length that is greater than twice the axial length of the staples disposed in system 100. In some embodiments, the energy source 516 is configured to maintain approximately the same rate of relative movement (eg, retraction of the sheath) at the location of a distally positioned staple and a proximally positioned staple.

The power source 516 may include a variety of components and deliver power or power to the system. For example, in one embodiment, power source 516 includes a gas cylinder that provides controlled retraction of the enclosure over the required distance. The power source 516 could be external to the housing 504 as shown in FIG. 47, and include, for example, a fluid channel connected to an external gas tank. In one embodiment, the gas in the housing 504 is contained in a small container that provides the required energy. In these embodiments, the system is not pressurized until the gas source is activated.

In order to initiate withdrawal of sheath 136 in relation to elongate body 132 and marker 168, a proximal piston 520 is coupled to sheath 136. The piston 520 is also disposed within the housing 504 to form part of a sealed system that is in fluid communication with the gas of the power source 516. The delivery device 500 is configured so that when a gas bolus is delivered in this confined space, the piston 520 in the housing 504 moves proximally. The proximal movement produces a corresponding proximal movement of the sheath 136.

The power source 516 need not be limited to a gas cylinder. In another embodiment, a compression spring is provided which is adapted to generate a substantially constant force. The spring is preferably arranged to exert sufficient force over a longitudinal length sufficient to expose as many prostheses as, for example, staples 140 as desired for the treatment. The distance or stroke length may be between about 10 mm and about 200 mm (for example, for a system which carries up to 20 staples or is operated to provide them). In certain embodiments, the stroke length is between about 8 mm and about 80 mm (for example, for a system carrying up to 10 staples or operated to provide them). In other embodiments, the stroke length is between about 7 mm and about 10 mm (for example, for a system which carries or is operated by a staple). In one embodiment, the spring is tensioned prior to retraction of the enclosure 136. In another embodiment, the spring is tensioned prior to use by the clinician (eg, at the factory).

As explained in more detail below, it may be desirable to be able to select the number of devices to be provided. In such circumstances, the provisioning system 500 may be configured to apply only a portion of the stroke of the spring. By selecting the number of staples to be provided, the handle would normally actuate the correct length of the spring and thus provide the adequate amount of force. As discussed below in SECTION IV (A) (4) (b), a selector may be included which allows the clinician to provide a series of staples 140, for example, a subset of the full number of staples on the delivery system that are at a particular one Provisioning event should be provided.

By compressing the gas also a spring-like force can be generated. For example, a structure analogous to piston 520 could be urged and held distally within the handle and released only when provision is to be made. The compressed gas would cause the piston to displace proximally along the sheath. This effect can be considered as a kind of springback.

Another spring arrangement which could be employed comprises a bellows spring which could be advantageous in structures in which a longer movement is required to retract the sheath. In this arrangement, the power source 516 is adapted to act over two points of the bellows spring. The energy source could include a gas or liquid under pressure acting on one end of the bladder to initiate the movement of the bladder. While the energy spring is allowed to spring back, the distance the bellows retracts is a multiple of the distance traveled by the energy source spring. This system provides high force conversion of a spring into the low force of controlled retraction over long distances.

Another option would be the use of a rotary spring which drives a lead screw. The spring could be biased and connected to a lead screw. The sheath 136 would then be connected to a driver which moves upon rotation of the lead screw. This would allow the rotational movement provided by the spring to be converted by adequate strength through the lead screw into a proximal (linear) movement of the sheath. b. Selector for Providing Multiple Prostheses An elongated treatment area, which may include, for example, plaque or an elongated vascular flap, may be treated with a plurality of staples 140. In certain procedures, it is possible by visualization or other surgical planning tool to know the number of staples or prostheses needed to provide adequate treatment. For these methods, the delivery system 500 may include a selector 532 to determine the number of prostheses or staples to be provided. In one form, the selector 532 may include marks 534 on one or more elongated body (s) 132 and the enclosure 136. These markers may give a visual indication to the clinician holding the handle 11F, the fitting 108, or the housing 504 of how many staples have been provided. FIG. 32A indicates the markers 534 disposed on a proximal part of the elongate body 132. The proximal movement of the enclosure 136 causes an adapter 208 to pass through each of a plurality of indicia 534. Each time the adapter 208 passes a marker 534, a staple 140 is exposed and may be provided. Thus, the user can know how many staples 140 are provided by watching the movement of the adapter 208 over the markers 534.

FIG. 4A shows that the markers can also be placed on the handle 11F. In particular, the handle 11F is provided with a series of markings 534 indicating how far the sheath 13 has already moved. Each time the actuator 11G passes a marker 534, another staple 140 is moved out of the envelope 13 and may be provided.

In certain embodiments, it is preferred that the selector 532 be configured to prevent conditions that would allow deployment of more than a selected number of staples 140. In these embodiments, selector 532 also includes a limiter 536 which prevents the provision of more than a preselected number of staples. FIG. 48A shows that in one embodiment, the limiter 536 includes a slidable stop 538 that may be disposed about a proximal portion of the elongate member 132. A locking device, such as a thumbscrew, is provided for immobilizing the limiter 536 on the elongate member 132. A viewing window 540 in the limiter 536 indicates clues as to how many staples are provided when the sheath 136 is moved proximally into contact with the abutment 538, how many remain in the system, or other helpful indicators on the staging status. In this case, when the limiter 536 is disposed on a proximal part of the elongated body 132, "1" is displayed. This tells the clinician that as the sheath 136 contacts the stop 538, a staple is provided.

FIG. Figure 48B illustrates another variation in which the relative rotation of a proximal portion of the cuff 136 and a selector 560 disposed with the housing 504 may enable the user to determine the number of prostheses (eg, staples 140) that are provided is to select. In one embodiment, the selector 560 includes a rod 564 that extends into the lumen formed in the enclosure 136. The rod includes a pin or other radial protrusion 568 that extends outwardly into one of a plurality of notches 572 disposed on the inner surface of the sheath 136. The notches include proximally facing surfaces 576. Each counterclockwise notch 572, as shown in the figure, is progressively farther from the proximal end of the sheath 136. Each progressively more distant notch 572 permits a further increment of axial movement of the sheath 136 relative to the pin 568. Each increment of axial movement corresponding to the amount of movement required at the distal end to release a delivery platform 160 and a corresponding staple 140 , By rotating the enclosure 136 in relation to the pen from the illustrated position according to arrow A, a larger number of staples can be provided in a single stroke. Relative rotation may be provided by coupling the rod 564 to a dial and indicator disposed on the outside of the housing 504.

In a variation of the embodiment of FIG. 48B, the selector 560 may be configured as a cuff that is disposed about the enclosure 136. The enclosure 136 may be modified to include an outwardly projecting pin similar to the pin 568, and the collar may be modified to have notches. In this

Arrangement is the structure in FIG. 48B, labeled "564", an enclosure and the structure labeled "136" is the cuff disposed about the enclosure.

FIG. 48C illustrates a provisioning system 600 which is housed in a housing similar to that shown in FIG. 46, may be arranged. The system includes both a mechanical power source and a selector to select the number of staples to be provided. The system includes an actuator 604 coupled by a cable 608 to an energy storage device 612. The actuator 604 is mounted to a rigid body 606 that is also coupled to the elongated body 132. The energy storage device 612 may include a rotation spring that drives a lead screw. More specifically, the cable 608 is wrapped around a drum 610 that can rotate about the axis of a base screw 614. A spring is coupled to the drum 610 such that when the drum unwinds the cable 608, the spring is tensioned, and after the tension of the cable has been released, the spring causes the drum to rotate back in the opposite direction and the cable thus wound up again on the drum. The length of the cable 608 wound on the drum is equal to or greater than the linear distance from the distal end of the distal delivery platform 160 to the proximal end of the most proximal delivery platform 160. The selector includes a plurality of stoppers 620 disposed proximal to the sheath 136 are. The attacks can be activated or deactivated. A first stop 620A is located closest to the distal end of the sheath 136 and allows the sheath to move by an amount sufficient to provide only one staple 140. After the first staple is provided, the first stop 620A may be deactivated by being pressed into the rigid body 606, and a second stop 620B may be activated. The second stop allows the path of the enclosure 136, a distance sufficient to expose the second distal delivery platform 160 and the staple 140. After the second staple is provided, the second stop 620B may be deactivated by being pressed into the rigid body 606, and a third stop 620C may be activated. The third stopper allows the path of the enclosure 136, a distance sufficient to expose the third most distal delivery platform 160 and the staple 140. After the third staple is provided, the third stop 620C may be deactivated by being pressed into the rigid body 606, and a fourth stop 620D may be activated. The fourth stop allows the path of the enclosure 136, a distance sufficient to expose the fourth most distal delivery platform 160 and the staple 140. If more than four staples and platforms are provided, further stops 620 may be provided. The energy stored in the energy storage device 612 causes the actuator 604 to be automatically returned to the initial position for further deployment.

FIG. Fig. 48D illustrated another concept that could be used for a provisioning sequence where only one staple at a time is provided. This arrangement corresponds to a latch mechanism. The delivery system includes a selector device 660 having a plurality of tines 664 spaced axially along a rigid body 666. The tines 664 provide a rigid stop structure. A movable part 668 coupled to a proximal part of the enclosure 136 may be disposed between adjacent tines 664, for example distal to the tine 664 "2", between the tines "2" and "3", etc. The movable part 668 could be in front of the tine Providing a staple 140 proximal to but adjacent to the prong "2". An actuator powered by an energy source could be triggered, after which the sheath 136 and the movable member 668 coupled thereto slip proximally. The movable part 668 slips into contact with the prong "3". This provides a hard stop and can be helpful when using a relatively powerful power source. To provide additional staples, the movable member 668 would be sequentially moved to the prongs "4", "5" and "6". 5. Shuttle Provisioning Device A shuttle providing device 700 as shown in FIG. 49, one or more delivery platforms (s) 160 may be included. The delivery platform 160 may include a marker band 168 at one or both ends thereof as discussed above. A set of rails, fingers or tines 702 may extend from one end of each marker tape 168. In the illustrated embodiment, there are 4 rails 702, although a higher or lower number may be used. The rails 702 may extend distally from a proximal marker band 168A. In other embodiments, the rails 702 extend proximally from a distal marker band 168B. The proximal and distal marker bands 168A, 168B are shown in FIG. 36A and may be proximal and distal portions of a single band or separate bands that are axially spaced apart. Only one set of rails 702 is shown. However, it will be appreciated that in other embodiments, a set of rails 702 may be provided for each delivery platform 160. The rails 702 may have a compressed position, as when in the enclosure 136, and an expanded position in which they are unrestricted. In the expanded position, the rails may be bent, flared, angled, or otherwise configured such that the shuttle 700 has a reduced dimension transverse to the longitudinal axis of the elongate member 132 proximal along its length.

As the sheath 136 is withdrawn, the rails move outwardly toward the vessel wall to the expanded position, as shown. Thereby, the catheter can be centered and a kind of ramp or gradual increase in diameter can be established so as to guide the positioning and expansion of the staple 140. As the staple 140 expands, it may slide down the rails to the designated position in the vessel wall. The radial expansion of the staple 140 is thus controlled because the struts are restricted by the radial rails to the degree of expansion. The staples 140 may be crimped about the rails 702, or they may be crimped with some rails inside the staple 140 and with some rails around the rails.

The shuttle 700 may be disposed at the distal end of the elongate body 132. As shown, the shuttle apparatus 700 has a plurality of gaps between the plurality of rails 702. These gaps may be used to assist in the proper positioning of the staple 140. For example, anchors, markers, and / or other features of the staple 140 may project radially through the gap such that a portion of the staple is radially intermediate between the rails and the longitudinal axis of the elongate member and another portion is in a radial circumferential position between (FIG. or beyond) adjacent rails. In this position, at least a portion of the rail may be considered to be radial between a portion of the rail and the longitudinal axis of the elongated portion 132.

This configuration can provide many advantages, such as preventing rotation and providing additional control in the placement of the staple 140 in the vasculature. The gaps may also facilitate anchoring positions of the staple anchors 20 that connect to the vascular system at the distal end of the shuttle 700 or rail 702.

In some embodiments, the rails 702 of the shuttle are adapted to the closed position. At the same time, the staple 140 may be a self-expanding staple 10 that is adapted to move to its expanded configuration. When the self-expanding staple is loaded into the shuttle, these two opposing influences create stored energy within the shuttle after the shroud is in the designated position and both are constrained to the appropriate position. The impact on the staple may be greater than the impact on the rails, such that the tendency to collapse is slightly less than the energy of the staple for expansion. Thus, after the sheath has been withdrawn from the delivery platform 160, the opposing forces may cause controlled expansion as the staples exit the distal end of the delivery catheter. This can advantageously reduce or eliminate too rapid expansion of the staple 140, which can lead to unpredictable placement.

Use of the plaque staple after drug eluting balloon angioplasty The use of plaque stapling devices can be combined with the use of a drug-eluting balloon (DEB) angioplasty for the management of post-angioplasty dissection and the need for To eliminate stents. In DEB angioplasty, a drug-eluting balloon or drug-coated balloon is prepared in a conventional manner. The drug may be a biological agent - or a combination thereof - used for a variety of functions, such as anti-thrombotic, anti-mitotic, anti-proliferative, anti-inflammatory, healing-stimulating or other functions. The DEB is provided on a guidewire via a blockage or constriction area in a blood vessel system. The DEB is inflated to a certain pressure and for a period consistent with the manufacturer's guidelines for treatment, as applicable to the drug coating and the intended results, then the DEB is deflated and removed. At this stage the medication was transferred from the DEB to the wall of the blood vessel. Then, intravascular ultrasound imaging is used to assess the integrity of the artery and the smoothness of the blood vessel surface at the site where the balloon was inflated. The presence of damage along the surface can manifest as dissection, plaque elevation, tissue tearing, surface irregularity. The plaque staple is used to staple the damaged, torn, dissected, or irregular blood vessel surface. This can create a "stent-free" environment, even if damage to the blood vessel has occurred as a result of balloon angioplasty.

In this phase, the medication was transferred from the DEB to the wall of the blood vessel. Contrast agent is administered by fluoroscopy into the blood vessel or another method, such as intravascular ultrasound, is used to assess the integrity of the artery and the smoothness of the blood vessel surface at the site where the balloon was inflated. In some cases, one or more final studies demonstrate the presence of damage along the surface at the site of balloon inflation. This damage can include dissection, plaque elevation, tissue rupture, surface irregularity.

The plaque staple delivery catheter is populated with a plurality of staples that are placed at the discretion of the user and can be advanced over a guidewire to the location of the blood vessel where the dissection or tearing or anomaly has occurred. The site is specific and carefully selected using angiography. The plaque staple (s) is provided at the site (s) of the lesion. To staple a larger dissection, more than one staple may be set. If more than one staple is set, it may only be placed in accordance with the staple stapling requirements. Ie. the staple should be at least one axial staple length away. After placement of the staple, it may be further expanded into the wall of the blood vessel using a standard angioplasty balloon or a drug-eluting or drug-coated balloon (either as a (separate) device or integrated into the delivery system). The purpose of the staple is generally not to keep the blood vessel lumen open, but to staple the non-smooth or dissected surface of the blood vessel. This "patching strategy" allows for the repair of the damage caused by the drug-eluting or drug-coated balloon without resorting to stent placement and maintaining a "stent-free" environment.

As another measure, as described above, the plaque stapling device itself can be used to administer the medication into the blood vessel. In addition to providing the medication through the anchors, the staple may be coated with a medication prior to placement of the staple. The purpose of this action is to allow the staple to elute the biological agent or biological agents that have beneficial effects on the blood vessel.

[00300] One or more of the staples provided in accordance with the present invention may be coated with a drug or otherwise carry a drug which is eluted at the delivery site over time. Any of a variety of therapeutically-beneficial agents may be used, including, but not limited to, for example, agents for inhibiting restenosis, inhibiting platelet aggregation, or promoting endothelialization. Some of the suitable agents may include smooth muscle cell inhibitors such as rapamycin, angiopeptin and monoclonal antibodies capable of blocking smooth muscle cell proliferation, anti-inflammatory agents such as dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, acetylsalicylic acid and Mesalamine, lipoxygenase inhibitors; Calcium entry blockers such as verapamil, diltiazem and nifedipine; antineoplastic / antiproliferative / anti-mitotic agents such as paclitaxel, 5-fluorouracil, methotrexate, doxorubicin, daunorubicin, cyclosporin, cisplatin, vinblastine, vincristine, colchicine, epothilones, endostatin, angiostatin, squalamine, and thymidine kinase inhibitors; L-arginine; antimicrobial agents such as astriclosan, cephalosporin, aminoglycosides and nitorfuirantoin; Anesthetics, such as lidocaine, bupivacaine and ropivacaine; Nitric oxide (NO) donors, such as lisidomine, molsidomine, NO protein adducts, NO polysaccharide adducts, polymer or oligomer NO adducts, or chemical complexes; Anticoagulants, such as D-Phe-Pro-Arg-chloromethyl ketone, an RGD-peptide-containing mixture, heparin, antithrombin mixtures, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet-receptor antibodies, eno-xaparin, hirudin , Warafine sodium, dicumarol, aspirin, prostaglandin inhibitors, platelet inhibitors, and thick antiplatelet agents; Interleukins, interferons and free radical scavengers; Promoters of vascular cell growth such as growth factors, growth factor receptor antagonists, transcriptional activators and translational promoters; Inhibitors of vascular cell growth, such as growth factor inhibitors (eg, PDGF inhibitor - trapidil), growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies to growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional nale molecules consisting of an antibody and a cytotoxin; Tyrosine kinase inhibitors, chymase inhibitors, e.g. B. Tranilast, ACE inhibitors, eg. , Enalapril, MMP inhibitors (eg, ilomastat, metastat), GP IIb / 1 Ila inhibitors (eg, intergrilin, abciximab), seratonin antagonist, and 5-HT reuptake inhibitors; Cholesterol lowering agents; vasodilating agents; and agents that interfere with endogenous vasoactive mechanisms. Polynucleotide sequences may also function as anti-restenosis agents, such as p15, p16, p18, p19, p21, p27, p53, p57, Rb, nFkB and E2F baits, thymidine kinase ("TK") and combinations thereof and other agents which helpful to prevent cell proliferation. The selection of an active agent may be made taking into account the desired clinical outcome and the nature of the condition and contraindications of a particular patient. With or without the inclusion of a drug, each of the staples disclosed herein may be made of a biodegradable material. Various polymer carriers, bonding systems or other coatings to allow for controlled release of the drug from the staple or its coating are well known in the art of coronary stents and are not recited herein.

In conclusion, the plaque staple can be used for plaque retention after balloon angioplasty treatment of atherosclerotic occlusive disease, avoiding problems with the use of stents through the introduction of a large mass of foreign material into the body this incorporation can lead to injury, inflammation and / or create restenosis sites.

Unlike stents, the plaque stapling device minimizes the material structure while it is installed only at one or more plaque dissection sites that require attention. The focal lift elements on the staple periphery minimize the contact surface area of the plaque staple with the blood vessel walls and reduce the risk of causing plaque dissection or injury to the blood vessel walls. This approach offers clinicians the ability to perform minimally invasive post-angioplasty treatment and achieve a stent-like result without the use of a stent.

While this invention has been disclosed in terms of certain preferred embodiments and examples, it will be apparent to those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or applications of the invention and obvious modifications and equivalents extends from it. In addition, it is conceivable that various aspects and features of the invention described may be performed separately, combined with each other or replaced with each other, and that a variety of combinations and sub-combinations of the features and aspects may be provided which still fall within the scope of the invention. Thus, it is intended that the scope of the present invention disclosed herein should not be limited by the particular forms of the invention described and disclosed herein, but should be determined solely through an adequate interpretation of the claims.

In the following, further embodiments will be described in order to facilitate the understanding of the invention.

A vascular prosthesis delivery system comprising: an elongate body comprising a proximal end, a distal end, and a plurality of delivery platforms disposed adjacent the distal end, each of the delivery platforms including a recess extending distally extends from a radial protrusion; a sheath having a proximal end, a distal end, and an elongate body extending therebetween, the sheath in relation to the elongate body from a first position in which the distal end of the sheath is disposed distal to a distal distal delivery platform move a second position in which the distal end of the sheath is disposed proximal to at least one delivery platform. a plurality of intravascular staples, each intravascular staple disposed about a respective delivery platform; wherein the system is configured to place at least two staples in a treatment area at spaced locations such that a minimum gap is provided in the treatment area between the distal end of a proximal staple and a proximal end of a distal staple without the delivery platforms have to be moved.

2. The system of embodiment 1, further comprising a stabilization device disposed on an outer surface of the system, configured so that at least one displacement - axially or radially - of at least one delivery platform along or away from a longitudinal axis of a blood vessel which the staples are provided is minimized.

The system of embodiment 1, wherein the stabilization device is disposed between the distal end of the elongated body and at least one of the delivery platforms, the stabilization device being adapted to anchor directly into a plurality of locations that surround one another Body lumen are arranged around to minimize the movement of the elongated body in relation to the body lumen, when the relative movement between the sheath and the elongated body is provided.

4. The system of embodiment 2, wherein the stabilizer comprises an expandable balloon having a cylindrical configuration.

5. The system of embodiment 2, wherein the stabilizer is disposed at the distal end of the elongated body and includes a conical balloon.

The system of Embodiment 2, wherein the stabilizing device comprises a self-expanding part.

7. System according to embodiment 6, wherein the self-expanding part is a

A plurality of axially extending arms, each arm having a proximal end coupled to the elongated body and a distal end, each of the arms configured to be held by the enclosure in a flat configuration which abuts the distal end of the arms to the elongate body and in which it extends radially away from the elongate body when the sheath is disposed proximally to the arms such that the distal ends of the arms are positioned to be in an apposition a body lumen comes.

8. The system of Embodiment 6, wherein the self-expanding part is a

Braid structure configured to be held by the sheath in a flat configuration and extending radially away from the elongate body when the sheath is disposed proximally of the braid structure.

9. The system of embodiment 2, wherein the stabilizer device is configured so that it can be actively enlarged from a flat configuration to an expanded configuration.

10. The system of embodiment 8, wherein the flat configuration enables advancement of the enclosure over the stabilizer without the enclosure having to be radially expanded.

The system of embodiment 8, wherein the stabilization device comprises a stabilization element adapted to expand radially when compression forces are applied to the proximal and distal ends thereof.

12. The system of embodiment 1, wherein the system includes between 3 and 20 staples arranged on respective delivery platforms.

The system of embodiment 1, wherein at least one of the delivery platforms comprises an expandable member so as to expand a staple disposed thereon.

14. The system of embodiment 13, wherein the expandable part is a radial one

Protrusionsbereich which is configured so that it rotates at least in the expanded state, a staple anchorage outside a cylindrical plane containing proximal and distal parts of the staple.

15. The system of embodiment 13, wherein the expandable portion comprises a drug-eluting balloon.

16. The system of embodiment 1, wherein the wrapper is a first wrapper, and further comprising: a second wrapper disposed about the first wrapper, wherein the second wrapper is configured to provide frictional forces along the outer surface of the first wrapper thereon be prevented to avoid unwanted movement of the elongated body during the placement of the staples.

17. The system of embodiment 16, wherein the second sheath has a length sufficient to extend from a femoral artery of a patient's leg via the aortic fork into at least the iliac artery of the other leg of the patient and distally to each further turn below the iliac artery in the other leg.

18. The system of embodiment 17, wherein the system has an advance delivery configuration in which the first enclosure is fully inserted into the second enclosure, and wherein, in the pre-deployment configuration, at least one intravascular staple is distal to the distal one End of the second envelope is arranged.

19. The system of embodiment 16, wherein the second enclosure has an improved lubricity on an interior surface thereof to reduce the frictional forces below a threshold so as to eliminate unwanted movement of the elongated body due to such friction.

20. The system of embodiment 1, wherein the stabilizer is configured to maintain the axial position of a distal facing surface of a first annular marker band within 50% of a length of a delivery platform, wherein the length of the delivery platform is parallel to the longitudinal axis of the elongate body between a distally facing surface of an annular marker band located at the proximal end of the delivery platform and a proximal facing surface of an annular marker band located at the distal end of the delivery platform.

21. The system of embodiment 1, wherein the stabilizer device is configured to maintain the position of a central longitudinal axis of the elongate body within 50% of the radius of the blood vessel in axial positions corresponding to delivery platforms.

22. The system of embodiment 1, further comprising a hand-triggering device connected to the proximal end of at least one option of elongate body and sheath to effect retraction of the distal end of the sheath relative to the elongate body to expose the delivery platforms to allow delivery of the staples.

23. The system of embodiment 22, wherein the manual release comprises a selector to set an increment of movement of the enclosure corresponding to a number of staples to be provided.

24. The system of embodiment 22, wherein the manual release is a mechanical

Energy source to generate a constant force for movement of the enclosure in relation to the elongated body.

25. The system of embodiment 1, further comprising one or more of a

Ultrasonic or optical imaging device, an atherectomy device, a balloon angioplasty device or a cryoplastics device.

26. The system of embodiment 1, further comprising a shuttle disposed at the distal end of the elongated body, the shuttle having a distal end configured to anchor directly into the vascular system. a plurality of rails extending proximal to the distal end and a plurality of columns disposed between the rails, the columns being configured so that anchor portions of the staple anchors connect to the vascular system at the distal end of the shuttle with the shuttle being configured so that the staples slide distally along the rails while undergoing a gradual expansion as the staples separate from the delivery system.

27. The system of embodiment 26, wherein the rails of the shuttle are arranged with stored energy such that the tendency for collapse is slightly less than the energy of the staples for expansion, resulting in controlled expansion when the staples are distal Exit the end of the delivery catheter.

[00330] 28. A method of placing a plurality of intravascular staples, comprising:

Providing a catheter system including an elongate body having a plurality of spaced apart platforms disposed adjacent a distal portion of the elongated body, the position of the at least one of the delivery platforms being indicated by a marker band, each platform having a plaque staple thereon has arranged.

Advancing the distal portion of the elongate body through a patient's vasculature until the marker band is proximal or distal to a dissected plaque treatment area.

Visualization of the marker band to confirm the position of at least one of the delivery platforms in relation to the dissected plaque.

Retracting the outer wrapper while maintaining the position of the elongated body, and thereafter providing at least two of the staples to place the staples in a predetermined position and at predetermined intervals.

29. The method of embodiment 28, further comprising stabilizing the elongated body by the operation of a stabilizer disposed prior to providing the staple at the distal end of the catheter.

30. The method of embodiment 29, wherein stabilizing includes maintaining the central longitudinal axis of the elongate body within 50% of the radius of the unconstrained expanded staple.

31. The method of embodiment 29, wherein the stabilization includes maintaining the axial position of the marker band within 50% of the length of the delivery platforms.

32. The method of embodiment 29, wherein the stabilizer comprises a vessel anchoring device disposed distal to the most distal delivery platform, and wherein the stabilization further comprises anchoring the vessel anchoring device in the vascular system prior to deployment.

33. The method of embodiment 32, further comprising separating the vessel anchoring device from the vascular system; positioning the vessel anchoring device within a provided staple; and expanding the vessel anchoring device to enhance blood flow through the staple.

34. The method of embodiment 29, wherein at least one of the delivery plate forms includes a balloon, and further comprises expanding the balloon to enlarge the staple disposed thereon and to fix the plaque to the luminal wall.

35. The method of embodiment 32, wherein the system further comprises a sheath disposed over the balloon, and further comprising retracting the sheath relative to the balloon prior to expansion of the balloon.

36. The method of embodiment 29, wherein providing the staples comprises retracting a sheath in a single pass by a distance greater than a distance from a distal end of a distal delivery platform to the proximal end of a proximal delivery platform single pass provides at least two staples.

37. The method of embodiment 28, wherein providing the staple comprises retracting an overwrap by increments greater than twice a compressed length of a staple.

38. The method of embodiment 28, further comprising selecting a

Increments corresponding to a number of staples to be provided, and retracting the wrap around the selected increment.

39. The method of embodiment 28, further comprising actuating a

Selector to limit the provisioning step to no more than a selected number of staples over a treatment area length.

40. The method of embodiment 28, further comprising providing a

Friction isolation wrap between the outer wrapper and the vasculature prior to retraction of the outer wrapper so as to reduce inadvertent movement of the delivery platforms.

41. A system for providing a vascular prosthesis, comprising: an elongated body comprising a distal end, a proximal end, and a piston disposed adjacent the distal end; an elongated package having a plurality of intravascular staples coupled thereto, the staples being disposed along the length of the elongated package; an enclosure having a proximal end and a distal end, the enclosure being movable relative to the elongated body from a first position wherein the distal end of the enclosure is distal to at least a portion of the elongated package, to a second position, in FIG wherein the distal end of the sheath is disposed proximal to the elongate packet; and wherein the elongated package is configured to maintain a minimum distance between the adjacent staples during deployment and to allow for expansion and separation from the elongated body, the elongated package being configured to release the staples to rebound can expand the provision in the direction of a vessel.

42. The system of embodiment 41, wherein the elongated package comprises a portion extending axially through a central region of the staples, the portion being coupled to each of the staples to confine the staples in a flat configuration.

43. The system of embodiment 41, wherein the elongated package is elongated

Cuff and a ripcord, wherein the ripcord is coupled to the sleeve so that the staples can expand by separating the ripcord from the cuff in the direction of a vessel wall.

44. The system of embodiment 43, wherein the cuff comprises a woven structure.

45. The system of embodiment 43, wherein the elongate package comprises a bioabsorbable material or a non-reactive polymer that is left between the system and the vascular system, whereby the staples can be absorbed into the vascular system.

46. The system of embodiment 43, wherein the radial protrusion is an annular one

Marker tape includes.

Claims (13)

claims A system for providing a vascular prosthesis, comprising: an elongated body (11A, 132) having a proximal end (152), a distal end (156), and a plurality of delivery platforms (160) disposed adjacent to the distal end are; a sheath (13, 136) having a proximal end (192), a distal end (198) and an elongate sheath body (200) extending therebetween, the sheath being movable relative to the elongate body (132) a first position, wherein the distal end of the sheath is located distal to a distal distal delivery platform, to a second position, wherein the distal end of the sheath is proximal to at least one delivery platform; a plurality of self-expanding vascular prostheses (10, 10 ', 10 ", 140), each vascular prosthesis having a plurality of struts (26, 27, 28, 29) forming a plurality of cells (16) and a corresponding one Delivery platform (160) is arranged, wherein the system is configured to place at least two vascular prostheses separately, one after the other, at a treatment area at spaced locations, so that a gap between the distal end of a proximal vascular prosthesis and the proximal end of a distal vascular prosthesis, each self-expanding vascular prosthesis in the plurality of self-expanding vascular prostheses having an ear and a radiopaque marker (22) positioned in the ear. The system of claim 1, wherein the radiopaque marker (22) in the eyelet has a planar or flat shape. A system according to any one of the preceding claims, wherein the radiopaque marker (22) is pressed or adhered to the eye. A system according to any one of the preceding claims, wherein the eyelet is disposed on an edge of the self-expanding vascular prosthesis (10, 10 ', 10 ", 140). A system according to any one of the preceding claims, wherein the eyelet is disposed on a centerline of the self-expanding vascular prosthesis (10, 10 ', 10 ", 140). A system according to any one of the preceding claims, further comprising a handle (11F) and an actuator (11G), said actuator (11G) being coupled to a proximal end of the sheath (13) such that proximal movements of the actuator (11G) cause proximal movement of the sheath (13). The system of claim 6, further comprising markings (534) on the handle (11F) to indicate how many prostheses have been dispensed. A system according to any one of the preceding claims, wherein each delivery platform (160) comprises at least one marker band, the at least one marker band being frusto-conical in both directions. A system according to any one of the preceding claims, wherein each of the self-expanding vascular prostheses (10, 10 ', 10 ", 140) is placed in the plurality of self-expanding vascular prostheses in the respective delivery platform such that in a treatment region having a length of 6 6 cm multiple prostheses can be placed so that 60% or less of the treatment area are covered. A system according to any one of the preceding claims, wherein each of the self-expanding vascular prostheses (10, 10 ', 10 ", 140) in the plurality of self-expanding vascular prostheses has a length of 15 mm or less and of the self-expanding vascular prosthesis in the next delivery platform is spaced by at least 2 mm. A system according to any one of the preceding claims, wherein each of the self-expanding vascular prostheses (10, 10 ', 10 ", 140) in the plurality of self-expanding vascular prostheses has a length of 15 mm or less and of the self-expanding vascular prosthesis in the next delivery platform is spaced by at least 4 mm. A system according to any one of the preceding claims, wherein the plurality of struts (26, 27, 28, 29) form a plurality of closed cells (16). The system of any one of the preceding claims, wherein each of the self-expanding vascular prostheses (10, 10 ', 10 ", 140) in the plurality of self-expanding vascular prostheses has a length of 8 mm or less and of the self-expanding vascular prosthesis in the next delivery platform is spaced by at least 4 mm.