AU2012258286B2 - Covered stent with proximal and distal attachment, delivery catheter, and method of making same - Google Patents

Abstract

Abstract A metallic or pseudometallic covered stent in which the stent component and the cover component are each fabricated of biocompatible metallic or pseudometallic materials, in 5 which the cover and the stent are joined by at least one juncture at each of a proximal and distal end of the stent and the cover. A method of joining the stent and the cover is also disclosed. -115

Description

P/00/011 Regulation 3.2 AUSTRALIA Patents Act 1990 ORIGINAL COMPLETE SPECIFICATION STANDARD PATENT Invention Title: "COVERED STENT WITH PROXIMAL AND DISTAL ATTACHMENT, DELIVERY CATHETER, AND METHOD OF MAKING SAME" The following statement is a full description of this invention, including the best method of performing it known to me/us: TITLE: [00011 COVERED STENT WITH PROXIMAL AND DISTAL ATTACHMENT, DELIVERY CATHETER, AND METHOD OF MAKING SAME 5 BACKGROUND OF THE INVENTION 100021 The present invention pertains generally to implantable medical devices and, more particularly, to implantable medical devices which are capable of being implanted utilizing minimally-invasive delivery techniques. More particularly, the present 10 invention relates to covered stents, stent-grafts and stent-graft-type devices that are implanted into anatomical passageways using minimally invasive delivery techniques. More specifically, the present invention comprises covered stents, stent-grafts and stent graft-type devices that are fabricated entirely of biocompatible metals or of biocompatible materials which exhibit biological response and material characteristics substantially the 15 same as biocompatible metals, such as for example composite materials (hereinafter referred to as "pseudometals" or by the property of being "pseudometallic"). Most specifically, the present invention relates to metal stents and metal stent covers wherein the metal stent cover is attached by at least one juncture between the metal stent at each of proximal and distal ends thereof. 20 [00031 Stents are typically lattice structures capable of adopting both a diametrically compressed configuration, for delivery to the site of deployment, and a diametrically expanded configuration, in which the stent presses outward and against the inner wall of the anatomical passageway to provide structural support to the vessel, 25 restore and maintain vascular patency. Endoluminal stents, for example, are frequently used post-angioplasty to provide a structural support for a blood vessel and reduce the incidence of restenosis following percutaneous balloon angioplasty. For example, endovascular stents may be introduced to a site of disease or trauma within the body's vasculature from an introductory location remote from the disease or trauma site using an 30 introductory catheter, passed through the vasculature communicating between the remote introductory location and the disease or trauma site, and released from the introductory catheter at the disease or trauma site to maintain patency of the blood vessel at the site of disease or trauma. - 1- [00041 In many applications, it is desirable to provide a stent with a covering capable of conferring particularly desirable properties that the stent alone does not possess. For example, bare stents have been associated with significant restenosis rates and, due to the typically large fenestrations in the walls of the stent required to 5 accommodate stent expansion from the compressed to the expanded diametric stage, permit particulate material, such as fragmented plaque, to pass from the vessel wall into the bloodstream. The relatively large fenestrations permit particulate material resident on the vascular walls, such as friable plaque or embolic material, to pass through the fenestrations and into the general circulation. Such undesirable effects may be reduced, 10 however, by providing the stent with a covering over either the lumenal or ablumenal surfaces, or both surfaces, thereby forming a covered-stent or for purposes of this application, synonymously, a stent-graft. SUMMARY OF THE INVENTION 15 [00051 In accordance with the present invention, a covered stent having proximal and distal affixation points between the stent and the cover components is provided. 100061 Additionally, a method of attaching the cover to the stent is provided in 20 which the stent is loaded into a restraining sheath having a pusher assembly concentrically engaged in the restraining sheath; the stent is loaded to a depth within the restraining sheath which permits the proximal end of the stent to remain exposed from the end of the restraining sheath; the cover is concentrically engaged about the outer circumference of the restraining sheath and aligned such that the proximal end of the 25 cover is in concentric alignment with the proximal end of the stent; a proximal affixation is created between the proximal end of the stent and the proximal end of the cover; the restraining sheath is then positioned in co-axial alignment with a distal end of a constraining tube, and the pusher assembly actuated to push the stent and the proximally affixed cover into the distal end of the constraining tube to a point where the distal end of 30 the stent and the distal end of the cover are exposed; a distal affixation is created between the distal end of the stent and the distal end of the cover, and the now proximally and distally affixed stent and cover are passivated and subsequently positioned in co-axial alignment with a distal end of a constraining tube, and a pusher assembly actuated to push the stent and the proximally affixed cover into the distal end of the delivery catheter -2lumen; a pusher assembly is then loaded into the delivery catheter from the proximal end of the catheter, and a guidewire and atraumatic tip is loaded in retrograde fashion from the distal end of the delivery catheter. 5 [00071 The foregoing summary, as well as the following detailed description of preferred embodiments of the invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings embodiments which are presently preferred. It should be understood, however, that the invention is not limited to the precise arrangements and 10 instrumentalities shown. BRIEF DESCRIPTION OF THE DRAWINGS [00081 Figs. 1 A-ID present sequential side-elevational cross-sectional views 15 depicting a loading assembly in accordance with an inventive apparatus and method for preparing a proximally-joined covered stent assembly. [00091 Figs. 2A-2B present sequential side-elevational cross-sectional views of a transfer assembly in accordance with the inventive apparatus and method for preparing a 20 proximally- and distally-joined covered stent assembly. [00101 Figs. 3A-3C presents sequential side-elevational cross-sectional views depicting loading of the inventive proximally and distally-joined covered stent assembly into a delivery catheter. 25 [00111 Figs. 4A-4B presents sequential side-elevational cross-sectional views depicting loading of a proximally- and distally-joined covered stent assembly into a tapered catheter sheath in accordance with an alternative preferred embodiment of the present invention. 30 [00121 Figs. 5A-5B presents sequential side-elevational cross-sectional views depicting catheter assembly in accordance with the alternative preferred embodiment of the present invention. -3- 100131 Fig. 6A is an expanded side view of the stent with proximal and distal junction points; and Fig. 6B is an enlarged side view of the stent with the proximal and distal junction point. 100141 Fig. 7 is a photomicrograph illustrating a junction point of a stent welded 5 to a cover. DETAILED DESCRIPTION OF THE INVENTION 10015] Turning now to the accompanying figures, Figs. IA-ID depict the 10 preparation of a proximally-joined covered stent using a loading/welding fixture 40. Fig. IA depicts the loading of stent 10 into the lumen of loading sheath 30 of loading/welding fixture 40. Loading/welding fixture 40 consists generally of the cylindrical loading sheath 30 and a pusher rod 32 having an abutment member 34 coupled to one end of the pusher rod 32. The abutment member 34 is concentrically engaged within the lumen of 15 loading sheath 30 and is capable of reciprocal movement therein. The abutment member 34 and pusher rod 32 serve dual functions: first, the abutment member 34 acts as a stop during insertion of the stent 10 into the lumen of the loading sheath 30 to properly position the stent 10 therein, and second, the pusher rod 32 and abutment member 34 act to eject the proximally-affixed stent and cover from the lumen of the loading sheath 30. 20 [00161 Fig. lB depicts the loading of cover 20 over an ablumenal surface of the loading sheath 30. As is shown in Fig. 1 B, abutment member 34 is positioned within the lumen of loading sheath 30 a distance d 2 , such that the remaining opening of the lumen of loading sheath 30 has a length of dI. Length di also corresponds to the degree of 25 overhang or exposure of stent 10 from the proximal end region 31 of loading sheath 30 that is required for affixation of the cover 20 to the stent 10. The cover 20 is concentrically positioned over the ablumenal surface of the loading sheath 30 and a proximal end of the cover 20 is aligned with the proximal end of the stent 10, such that the loading sheath 30 is positioned intermediate the stent 10 and the cover 20, with the 30 exposed proximal end II of the stent 10 and the proximal end 21 of the cover 20 being in adjacent proximity therebetween. Therefore, as shown in the circled portion of Fig. 1 C, after cover 20 has been loaded over loading sheath 30, the proximal end region 11 of stent 10 and proximal end region 21 of cover 20 may be joined without interference from proximal end region 31 of loading sheath 30. Fig. ID depicts an exploded view of the -4circled region of Fig. IC, with an example of such a join between proximal end region 1I of stent 10 and proximal end region 21 of cover 20 shown by solid box 15. Thus Fig. 1 D depicts a proximally-joined covered stent assembly comprising stent 10 contained within cover 20 with a joining point 15 between the proximal end regions of stent 10 and cover 5 20. 100171 Figs. 2A-2B depict loading the proximally joined stent 10 and cover 20 into a constraining tube 50 and the subsequent formation of a distal juncture 16 between the stent 10 and the cover 20. Fig. 2A depicts a proximally-joined covered stent assembly prepared as in Fig. 1, which has been ejected from the loading sheath 30 by 10 axial movement of the pusher rod 32 and the abutment member 34 within the loading sheath 30. By bringing a constraining tube 50 into co-axial alignment with the loading sheath 30, as the proximally-joined covered stent assembly is ejected from the loading sheath 30, it is pushed into the constraining tube 50. The proximally-joined covered stent assembly is positioned in the constraining tube 50 such that the assembly extends and is 15 exposed from the distal end of the constraining tube 50 a distance d 3 . The exposed distal end of the assembly permits formation of a distal junction 16 between the stent 10 and the cover 20. [00181 Figs. 3A-3C depict the preparation of an assembly comprising a catheter 20 sheath 60, a proximally- and distally-joined covered stent 25, a pusher member 80, a guidewire shaft 70 and an atraumatic tip 90. In Fig. 3A, a proximally- and distally-joined covered stent assembly is partially contained within a catheter sheath 60. The proximally- and distally-joined covered stent assembly 25 of Fig. 3A may be obtained as shown in FIGS. I and 2. In Fig. 3B, the proximally- and distally-joined covered stent 25 assembly of Fig. 3A has been pushed completely within catheter sheath 60, while in Fig. 3C the assembly 25 of Fig. 3B, a guidewire shaft 70 is co-axially inserted through the central lumen of the covered stent assembly 25 and extends beyond the terminal (proximal) end of the pusher member 80 and the catheter sheath 60. An atraumatic tip 90 is affixed to a distal end of the guidewire shaft 70 prior to insertion of the guidewire shaft 30 70. The atraumatic tip 90 is retracted into abutting relation with a distal end of the catheter sheath 60, thereby enclosing the covered stent assembly 25 within the catheter sheath 60. -5- 100191 In accordance with the best mode for practicing the invention, cover 20 is preferably in its martensitic state and unstrained at room temperature, when positioned on the loading sheath 30. The stent 10, however, is preferably austenitic and should be loaded into the loading sheath 30 in the presence of a cooling medium, e.g., liquid 5 nitrogen bath, dry ice and alcohol bath, flow of chilled gas, etc. The stent in its compressed diameter is strained, thus, in order to operate the other manipulative steps, needs to be within the constraining tube 50 or the catheter tube. The protruding proximal or distal ends of the stent will, however, flare slightly as they are exposed to room temperatures after being loaded into the loading sheath 30 and the constraining tube 50. 10 This very slight flare, however, ensures good apposition between the stent 10 and cover 20 and facilitates forming ajunction between the stent 10 and the cover 20, such as by resistance spot welding. [00201 Figs. 4A-4B illustrate loading of the inventive covered stent assembly 25 15 into a catheter sheath 100 which acts to constrain the device from expansion. Fig. 4B depicts the proximally- and distally-joined covered stent assembly prepared as in FIGS. 1 A- 1 D, substantially inserted into constraining tube 50. [0021] Figs. 5A-5B depict the steps in completing the delivery catheter assembly 20 120 after a pusher member 110 is pre-engaged within the catheter sheath 100, as assembly of the pusher member 110 after the covered stent assembly 25 is in the catheter sheath 100 would be impracticable. The covered stent assembly 25 may then be fully inserted into the catheter sheath 100 as shown in Fig. 5A, such as by using a pusher member similar to the pusher member 34, 32 shown in Fig. I A, such that it abuts or is 25 immediately adjacent to the pusher member 110. Once the covered stent assembly 25 is fully inserted into the catheter sheath 100 and positioned in so that it abuts or is immediately adjacent to the pusher member, a guidewire shaft 122 is co-axially inserted through the central lumen of the covered stent assembly 25 and extends beyond the terminal end of the pusher member 110 and the catheter sheath 100. An atraumatic tip 30 130 is affixed to a distal end of the guidewire shaft 122 prior to insertion of the guidesire shaft 122. The atraumatic tip 130 is retracted into abutting relation with a distal end of the cathether sheath 100, thereby enclosing the covered stent assembly 25 within the cathether sheath 100. -6- [00221 In accordance with all aspects of the present invention, it is desirable that joining points 15 or 16 be formed by thermal methods, such as such as laser welding, plasma welding, resistance welding, and e-beam welding where both the stent 10 and the cover 20 are fabricated of metal or pseudometallic materials, preferably shape memory or 5 superelastic materials, most preferably, nickel-titanium alloys. However, where the stent 10 and the cover 20 are dissimilar materials, such as nickel-titanium alloy and stainless steel, welding is generally not an acceptable method for joining nickel-titanium alloy to other materials, such as stainless steel, because brittle intermetallics are formed in the weld zone. Thus, where nickel-titanium alloy is to be joined to another biocompatible 10 material, it is desirable to employ soldering, epoxies or adhesives to form the joining point 15. Alternatively, if welding dissimilar materials to nickel-titanium is desired, it is known to provide an interlayer material, such as tantalum, to minimize formation of brittle intermetallics during welding. 15 [00231 Finally, in accordance with the best mode of the invention and the preferred embodiment thereof and as illustrated in Figs. 6A and 6B, it is preferably to configure the stent 10 such that it has proximal and distal junction points 150 which provide a relatively larger, substantially planar surface area for creating the junction between the cover 20 and the stent 10. The junction points 150 may have a generally 20 quadrilateral shape in the X-Y axis of either the luminal or abluminal surface of the stent 10, preferably has the same Z-axis wall thickness as the remaining portions of the stent 10, and have a slight curvature corresponding generally to the curvature of the tubular stent 10. Fig. 7 is a photomicrograph illustrating a junction point 150 of a stent 10 welded to a cover 20. 25 [00241 Altematively, as described more fully in co-pending, commonly assigned patent application U.S. Publication No. US20040186554A 1, entitled, "Endoluminal stent having mid-strut interconnecting members" or in co-pending, commonly assigned patent application U.S. Publication No. US20040098094A1, entitled "Implantable graft and 30 methods of making same" the junction points 150 may be projections from terminal proximal and/or distal cylindrical members forming the tubular stent 10 (See, e.g., Fig. 1, element 11 in the '554 Publication or Fig. 27, elements 307 and 304a-e in the '094 Publication), each publication is hereby expressly incorporated by reference. -7- [00251 It is preferable, in accordance with the preferred embodiments of the invention, that when employing shape memory materials for both the stent and the cover, that the stent and the cover have different transition temperatures, such that the stent have its transition temperature below body temperature and diametrically expand when 5 exposed to body temperature, while the cover preferably has a transition temperature above body temperature so that it undergoes detwinned martensitic plastic deformation due to expansion of the stent upon implanting into the body. Thus, it is preferred that the stent have an Af _ 29*C ±3*C and the cover have an have an Af between about 60 to 100 *C. In this manner, the cover remains martensitic under all conditions which are likely to 10 be encountered during manufacture, delivery and after being implanted in vivo. The stent, on the other hand, having an Af less than body temperature, will be constrained in the delivery catheter and readily expand during implantation in vivo, and readily expand the martensitic cover along with the radial expansion of the stent. 15 100261 The following examples are provided in order to illustrate the alternative embodiments of the invention, and are not intended to limit the scope of the invention. Example 1: Preparation of a Proximally- and Distally-joined Stent Assembly Using a Constant Outer Diameter Catheter Sheath 20 [00271 A self-expanding shape memory nickel-titanium stent having a wall thickness of 127 pm, a 0.965 mm inner diameter ("ID") and 1.168 mm outer diameter ("OD") is loaded into a loading sheath of 1.194 mm ID and 1.295 mm OD of a loading/welding fixture, and a cover of 1.257 mm OD and 4.5 micron wall thickness is 25 loaded over the loading sheath. The proximal end region of the cover is then welded to the proximal end region of the crimped stent. 100281 The resulting proximally-joined covered stent assembly is slid into the distal end of a constraining tube having a 1.193 mm ID and 1.295 mm OD. The loading 30 sheath of the loading/welding fixture is then retracted, the distal end region of the cover is welded to the distal end region of the stent, and the weld is passivated in a nitric acid solution. -8- 100291 The resulting proximally- and distally- joined covered stent assembly is then slid completely into the constant outer diameter catheter sheath. In one non-limiting embodiment of the present invention, this assembly is chilled in order to facilitate sliding. A pusher shaft of 0.031" ID and 0.051" OD is then inserted from the proximal end of the 5 constant outer diameter catheter sheath, and a guidewire shaft of 0.018" ID and 0.027" OD comprising a proximal tip is inserted from the distal end of the constant outer diameter catheter sheath. Alternatively, the insertion of the guidewire shaft may precede the insertion of the pusher shaft. 10 Example 2: Preparation of a Proximally- and Distally-joined Stent Assembly Using a Tapered Catheter Sheath [0030] A self-expanding shape memory stent having a wall thickness of 127 pm is crimped to an inner diameter ("ID") of 0.97 mm with an outer diameter of 1.17 mm. The 15 crimped stent is then loaded into a loading sheath having a 1.19 mm ID and 1.295 mm OD of a loading/welding fixture, and a cover of 1.257 mm OD and 4.5 micron wall thickness is loaded over the loading sheath. The proximal end region of the cover is then welded to the proximal end region of the crimped stent. 20 [0031] The resulting proximally-joined covered stent assembly is slid into a constraining tube having a 1.193 mm ID and a 1.295 mmOD mm OD. The loading sheath of the loading/welding fixture is then retracted, the distal end region of the cover is welded to the distal end region of the stent, and the weld is passivated in a nitric acid. 25 [00321 The resulting proximally- and distally- joined covered stent assembly is then slid completely into the distal end of a tapered catheter sheath having an ID of 1.397 mm and a 1.600 mm OD distally, tapered to 1.092 mm ID and 1.295 mm OD proximally, where this tapered catheter sheath contains a preloaded catheter pusher shaft of 0.737 mm ID and 1.295 mm OD distally, tapered to 0.737 mm ID and 0.991 mm OD proximally. In 30 one non-limiting embodiment of the present invention, this assembly is chilled in order to facilitate sliding. A guidewire sheath of 0.457 mm ID and 0.686 mm OD and including an atraumatic tip is then inserted from the distal end of the tapered diameter catheter sheath. -9- [00331 While the present invention has been described with reference to its preferred embodiments, one of ordinary skill in the relevant art will understand that the present invention is not intended to be limited by these preferred embodiments, and is instead contemplated to include all embodiments consistent with the spirit and scope of 5 the present invention as defined by the appended claims. -10-

Claims (20)

1. A method for preparing the implantable medical device of claim comprising: a) loading a stent into a lumen of a loading tube such that a first end region of the stent projects beyond a first terminal end of the loading tube; b) loading a cover over the terminal end of the loading tube and slidably engaging the cover onto the loading tube such that a first terminal end of the cover is in apposition with the first end region of the stent that projects beyond the first terminal end of the loading tube; c) joining the first end region of the cover to the first end region of the stent in a first join to form a covered stent assembly having the first join; d) loading the covered stent assembly having the first join into a restraining tube such that a second end region of the cover and a second end region of the stent project beyond a terminal end of the restraining tube; and e) joining the second end region of the cover to the second end region of the stent in a second join to form the implantable medical device.

2. The method of claim 1, wherein steps c) and e) further comprise the step of forming the first join and the second join by resistance welding.

3. The method of claim 2, further comprising the step of passivating the covered stent assembly.

4. The method of claim 1, further comprising the step of transferring the covered stent assembly from the restraining tube into a catheter sheath.

5. The method of claim 1, further comprising the steps of: a) disposing a pusher member within the catheter sheath prior to loading the implantable medical device into the catheter sheath; b) sliding the implantable medical device into the catheter sheath such that it is at least in adjacent proximity to the pusher member; and c) disposing a guidewire sheath through a central bore in the pusher member and through a central lumen of the implantable medical device.

6. The method of claim 5, wherein said covering sheath further comprises a tapered catheter sheath. - 11 -

7. The method of claim 6, further comprising: a) disposing a pusher member within the tapered catheter sheath prior to loading the implantable medical device into the catheter sheath; b) sliding the implantable medical device into the tapered catheter sheath such that it is at least in adjacent proximity to the pusher member; and c) disposing a guidewire sheath through a central bore in the pusher member and through a central lumen of the implantable medical device.

8. A method of joining a stent with a cover, comprising the steps of: a) loading a stent into a lumen of a loading tube such that a first end region of the stent projects beyond a first terminal end of the loading tube; b) loading a cover over the first terminal end of the loading tube and slidably engaging the cover onto the loading tube such that a first terminal end of the cover is in apposition with the first end region of the stent that projects beyond the first terminal end of the loading tube; c) joining the first end region of the cover to the first end region of the stent in a first join to form a covered stent assembly having the first join.

9. The method of claim 8, wherein step c) further comprise the step of forming the first join by resistance welding.

10. The method of claim 9, further comprising the step of passivating the first join.

11. An implantable covered-stent, comprising: a) a self-expanding stent having structural members and a length defined between a most proximal vertex and a most distal vertex of the structural members, at least one enlarged member projecting from at least one of the most proximal vertex or the most distal vertex, wherein each of the at least one enlarged members has a substantially planar surface and a width greater than the width of any structural member of the stent, and at least one fenestration is disposed between the proximal vertex and the distal vertex; and b) a metal cover member having a proximal end region, a distal end region, wall surfaces and a plurality of openings passing through the wall surfaces, wherein each of the plurality of openings has an open surface area less than an open surface area of the at least one fenestration; wherein the proximal end region of said metal cover is joined by a thermal method in a first join to the at least one enlarged proximal member, and the distal end region - 12 - of the metal cover is joined by a thermal method in a second join to the at least one enlarged distal member, wherein the stent and the metal cover member are formed of the same biocompatible metal, and wherein the metal cover at least partially occludes the at least one fenestration to form an implantable covered-stent.

12. The implantable medical device of claim 11, wherein the stent and the metal cover have compatible degrees of foreshortening.

13. The implantable medical device of claim 11, wherein said stent and said metal cover are each composed of at least one material selected from the group consisting of titanium, vanadium, aluminum, nickel, tantalum, zirconium, chromium, silver, gold, silicon, magnesium, niobium, scandium, platinum, cobalt, palladium, manganese, molybdenum and alloys thereof, zirconium-titanium-tantalum alloys, nickel-titanium alloys, cobalt-chromium alloys and stainless steel.

14. An implantable medical device prepared according to the method of any of claims 1 to 8 or a covered stent assembly formed according to the method of any one of claims 8 to 10.

15. A method for preparing an implantable medical device or a method of joining a stent with a stent cover substantially as herein described.

16. A method for preparing an implantable medical device or a method of joining a stent with a stent cover substantially as herein described with reference to the figures.

17. A method for preparing an implantable medical device or a method of joining a stent with a stent cover substantially as herein described with reference to the examples.

18. An implantable covered-stent substantially as herein described.

19. An implantable covered-stent substantially as herein described with reference to the figures. - 13 -

20. An implantable covered-stent substantially as herein described with reference to the examples - 14 -