Stent with collagen

• US 5,693,085 A
• Filed: 04/26/1995
• Issued: 12/02/1997
• Est. Priority Date: 04/29/1994
• Status: Expired due to Term

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Buirge, Andrew W., Buscemi, Paul J., Burmeister, Paul H.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/429,308
• Time in Patent Office: 951 Days
• Field of Search: 623/1, 623/12, 606/192, 606/194, 606/195
• US Class Current: 623/1.13
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/828 Means for connecting a plurality of stents allowing flexibility of the whole structure
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 : sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2220/0091 : connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: C08L 89/06 : derived from leather or skin , e.g. gelatin
• CPC Class Codes: Y10S 623/917 : Collagen

Abstract

Collagen applied to a vascular stem for increasing the biocompatability of the stent on implantation find method of treatment.

Claims

1. In combination, a vascular prostheses comprised of an expandable support framework, the expandable support framework comprising a stent, which has an expanded state having a first diameter and a compressed state having a second diameter, the second diameter being smaller the first diameter, and is capable of being positioned at a targeted position within a lumen transluminally when the stent is in its compressed state, and a covering sleeve of a collagen material, the support framework and the covering sleeve being substantially the same length and substantially overlapping, and wherein the sleeve of collagen material is in sheet form and is oriented with respect to the longitudinal dimension of the stent such that the stretch properties of the collagen are on a bias with respect thereto.

2. The combination of claim 1 wherein the collagen material covers the stent inside and out.

3. The combination of claim 2 wherein the collagen is in the form of an outer sleeve and an inner sleeve.

4. The combination of claim 1 wherein the collagen material is comprised of collagen per se.

5. The combination of claim 1 wherein the collagen material is comprised of collagen on a support.

6. The combination of claim 5 wherein the support is a fabric.

7. The combination of claim 1 wherein the framework is a stent of variable diameter.

8. The combination of claim 7 wherein the stent is of the self-expanding type.

9. The combination of claim 1 wherein the sleeve has elastic properties.

10. The combination of claim 1 wherein the sleeve is sized large with respect to the framework at least before implantation.

11. The combination of claim 1 wherein the collagen includes added agent.

12. The combination of claim 11 wherein the agent is heparin.

13. The combination of claim 1 including a multi-layer arrangement of Type I and Type IV collagen material on the outside of the stent.

14. The combination of claim 13 wherein the Type IV is the outermost layer.

15. The combination of claim 14 wherein the Type IV is SIS.

16. In combination, a vascular expandable stent and a layer of collagen material in the form of a sleeve overlying the stent, the layer of collagen material being substantially the same length and substantially overlapping the stent so that when the combination is inserted within a vascular lumen, the layer of collagen material is positioned between the stent and the vascular wall of the lumen, and wherein the sleeve of collagen material is in sheet form and is oriented with respect to the longitudinal dimension of the stent such that the stretch properties of the collagen are on a bias with respect thereto.

17. In combination, a vascular prostheses comprised of a generally cylindrical expandable support stent, which has an expanded state having a first diameter and a compressed state having a second diameter, the second diameter being smaller than the first diameter, and is capable of being positioned at a targeted position within a lumen transluminally when the stent is in its compressed state, and an inner luminal liner comprising collagen material, wherein the collagen liner is in sheet form and is oriented with respect to the longitudinal dimension of the stent such that the stretch properties of the collagen are on a bias with respect thereto.

18. The combination of claim 17 wherein the collagen material comprises a bilayer arrangement.

19. The combination of claim 18 wherein one of the layers in the bilayer is a polymeric material.

20. The combination of claim 19 wherein the bilayer liner is comprised at least two types of collagen material.

21. The combination of claim 20 wherein the collagen material includes Type I and Type IV layers.

22. The combination of claim 21 wherein the Type IV is SIS.

23. The combination of claim 22 wherein the Type IV is the innermost layer and the Type I layer includes a drug.

24. The combination of claim 17 wherein the stent is of variable diameter.

25. The combination of claim 24 wherein the stent is of the self-expanding type.

26. The combination of claim 17 wherein the liner has cuffs at either end which overlap the ends of the stent.

27. The combination of claim 17 wherein the collagen includes an added agent.

28. The combination of claim 27 wherein the agent is heparin.

29. The combination of claim 17 wherein the stent has wall openings and the liner is perforated.

30. The combination of claim 29 wherein the perforations are about 10-60 microns in diameter.

31. The combination of claim 17 including SIS collagen material on the outside of the stent.

32. In combination, a vascular prosthesis comprised of an expandable stent, which has an expanded state having a first diameter and a compressed state having a second diameter, the second diameter being smaller than the first diameter, and is capable of being positioned at a targeted position within a lumen transluminally when the stent is in its compressed state, and inner and outer layer of SIS collagen material positioned on the stent, wherein at least one of the layers of collagen is in sheet form and is oriented with respect to the longitudinal dimension of the stent such that the stretch properties of the collagen are on a bias with respect thereto.

33. In combination, a vascular prosthesis comprised of an expandable stent, which is expandable from a first cylindrical position to a second cylindrical position and is capable of being positioned at a targeted position within a lumen transluminally when the stent is in its compressed state, a collagen coating on the stent and a collagen sleeve on the outside of the stent, wherein the sleeve of collagen is in sheet form and is oriented with respect to the longitudinal dimension of the stent such that the stretch properties of the collagen are on a bias with respect thereto.

34. The combination of claim 33 wherein the sleeve is SIS and the coating is Type I or Type IV.

35. An expandable stent, which is expandable from a first cylindrical position to a second cylindrical position and is capable of being positioned at a targeted position within a lumen transluminally when the stent is in its compressed state, comprised of a generally cylindrical body coated with a collagen material and carrying an overlying sleeve of collagen material, wherein the sleeve of collagen material is in sheet form and is oriented with respect to the longitudinal dimension of the stent such that the stretch properties of the collagen are on a bias with respect thereto.

36. The stent of claim 35 wherein the collagen coating is selected from the group consisting of Type IV and Type I.

37. The stent of claim 36 wherein the collagen sleeve is comprised of Type IV.