Endoluminal graft with integral structural support and method for making same

• US 6,053,943 A
• Filed: 05/28/1998
• Issued: 04/25/2000
• Est. Priority Date: 12/08/1995
• Status: Expired due to Term

• Current Assignee: Bard Peripheral Vascular Incorporated (Becton, Dickinson & Co)
• Original Assignee: IMPRA Incorporated (Becton, Dickinson & Co)
• Inventors: Banas, Christopher E., Edwin, Tarun J.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/077,533
• Time in Patent Office: 698 Days
• Field of Search: 623/1, 623/12, 600/36
• US Class Current: 623/1.25
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: B29C 48/00 Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor extrusion blow-moulding B29C49/04
• CPC Class Codes: B29C 48/07 Flat, e.g. panels
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/12 Articles with an irregular circumference when viewed in cross-section, e.g. window profiles
• CPC Class Codes: B29C 48/13 Articles with a cross-section varying in the longitudinal direction, e.g. corrugated pipes
• CPC Class Codes: B29C 53/14 Twisting for textile fibres D01H
• CPC Class Codes: B29C 53/58 helically
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

A structurally supported graft (10) having a support structure (26) with strain relief sections (30) contained with an internal surface, an external surface, or a wall thickness of a tubular graft member (12). The structurally supported graft (10) may include a beading element (24) which is co-extruded with the support structure (26) having strain relief sections (30) and spiraled about the tubular graft (10). The support structure (26) includes differing types of strain relief sections (30) which are capable of allowing for the longitudinal and radial expansion of the structurally supported graft (10), respectively. The strain relief sections (30) may also include unconnected ends which form outwardly protruding barbs (62) upon expansion of the structurally supported graft within a blood vessel or body lumen. The method for making the structurally supported graft includes selecting or preparing a support structure with strain relief sections, co-extruding the structural support with a beading element, forming a spiral about the tubular graft with the co-extruded structure, and securing the co-extruded structure to the tubular graft.

Claims

1. An endoluminal prosthesis, comprising:

a tubular graft member having a first open end, a second open end, and a wall having an interior surface and an exterior surface which are separated by a wall thickness, the wall being located between the first and second open ends wherein the interior surface of the wall defines a lumen; and

at least one structural support member coupled to the tubular graft member and containing a plurality of longitudinally deformable strain relief sections which permit contemporaneous longitudinal deformation of at least some of the plurality of strain relief sections and diametric expansion of the tubular graft members, wherein said strain relief sections are formed from a material having different mechanical properties than said tubular graft member.

2. The endoluminal prosthesis of claim 1, wherein said tubular graft member further comprises expanded polytetrafluoroethylene.

3. The endoluminal prosthesis of claim 1, wherein said structural support member further comprises a wire member.

4. The endoluminal prosthesis of claim 1, wherein the structural support is coupled to the tubular graft member by mechanical bonding with at least one of the exterior surface and within the wall thickness of the tubular graft member.

5. The endolurninal prosthesis of claim 1, wherein at least some of the plurality of strain relief sections further comprise barb-forming members which project barb members outwardly from a central axis of the support member upon diametric expansion of the tubular graft member.

6. The endoluminal prosthesis of claim 1, wherein the plurality of strain relief sections further comprise a plurality of first strain relief sections which permit longitudinal expansion of the tubular graft member and a plurality of second strain relief sections which permit diametric expansion of the tubular graft member.

7. The endoluminal prosthesis of claim 6, wherein the plurality of first and second strain relief sections each comprise longitudinal regions of the structural support member having differential moduli of elasticity.

8. The endoluminal prosthesis of claim 7, wherein the plurality of first strain relief sections further comprise recessed sections which extend into the structural support member substantially perpendicular to the longitudinal axis of the structural support member and the plurality of second strain relief sections further comprise recessed sections which extend in a direction substantially perpendicular to the longitudinal axis of the structural support member and substantially perpendicular to the direction of the first strain relief sections.

9. The endoluminal prosthesis of claim 1, wherein said structural support further comprises barb forming members which project away from the central longitudinal axis of the structural support member upon diametrical expansion of the tubular graft member.

10. The endoluminal prosthesis of claim 1, wherein the structural support member is covered by non-longitudinally expanded polytetrafluoroethylene and a plurality of the strain relief sections are exposed and uncovered by the non-longitudinally expanded polytetrafluoroethylene covering.

11. The endoluminal prosthesis of claim 1, wherein the structural support member is covered along its entire longitudinal axis by a longitudinally expanded polytetrafluoroethylene covering.

12. The endoluminal prosthesis of claim 1, wherein the tubular graft member further comprises at least one of a plurality of longitudinally extending rib structures projecting outwardly from the exterior surface of the tubular member, the at least one of a plurality of longitudinally extending rib structures is an integral and monolithic part of the wall thickness of the tubular member, and the structural support member is co-extruded within the at least one of a plurality of longitudinally extending rib structures.

13. The endoluminal prosthesis of claim 1, wherein the structural support member is co-extruded within the wall thickness of the tubular member.

14. The endoluminal prosthesis of claim 1, further comprising at least two micropororus expanded polytetrafluoroethylene tubular graft members and the at least one of a plurality of support members is interdisposed between the at least two microporous expanded polytetrafluoroethylene tubular graft members, the at least two microporous expanded polytetrafluoroethylene tubular graft members being in intimate contact with one another and substantially encapsulating the at least one of a plurality of support members therebetween.

15. The endoluminal prosthesis of claim 14, further characterized in that the at least two microporous expanded polytetrafluoroethylene tubular graft members have different porosity.

16. The endoluminal prosthesis of claim 14, further characterized in that the at least two microporous expanded polytetrafluoroethylene tubular graft members have node and fibril microstructures with the fibril orientation of the two microporous expanded polytetrafluoroethylene graft members being oriented substantially perpendicular to one another.

17. An integrally structurally supported graft, comprising:

an expanded polytetrafluoroethylene tubular graft member;

a beading bound about one of an outer and inner surface of the tubular member; and

at least one structural support member at least partially retained within the beading, the at least one structural support member having a plurality of deformable strain relief sections which deform under the influence of a longitudinally-oriented load thereby extending the longitudinal length of the at least one structural support members wherein said structural support member is made of a material, having different mechanical properties than said tubular graft member.

18. The graft of claim 17, wherein the beading comprises one of expanded polytetrafluoroethylene and non-expanded polytetrafluoroethylene.

19. The graft of claim 17, wherein the at least one structural support member is comprised of one of a ductile plastic and a ductile metal material.

20. The graft of claim 17, wherein the beading is circumferentially bound to the outer surface of the tubular graft member.

21. The graft of claim 17, wherein the beading is integrally bound to at least one of an interior surface, exterior surface, and wall thickness of the tubular member.

22. The graft of claim 17, wherein the plurality of strain relief sections further comprise weakened sections of the structural support member.

23. The graft of claim 17, further comprising a plurality of uncovered strain relief sections.

24. The graft of claim 17, further comprising a plurality of barb-forming members on the structural support members, the plurality of barb-forming members being deformable to project away from the longitudinal axis of the structural support member upon longitudinal expansion of the structural support member.

25. The graft of claim 24, wherein said plurality of deformable strain relief sections further comprise a plurality of first strain relief sections and a plurality of second strain relief sections and wherein the plurality of first strain relief sections comprises weakened sections which extend into the structural support member substantially perpendicular to the longitudinal axis of the structural support member and the plurality of second strain relief sections further comprise weakened sections which extend in a direction substantially perpendicular to the longitudinal axis of the structural support member and substantially perpendicular to the direction of the first strain relief sections.

26. The graft of claim 17, wherein the structural support member is helically disposed relative to the tubular graft member.

27. The graft of claim 17, wherein the structural support member and the tubular graft member are co-extruded with one another.

33. The graft of claim 17, wherein the plurality of strain relief sections further comprise a plurality of first strain relief sections which permit longitudinal expansion of the tubular graft member and a plurality of second strain relief sections which permit diametric expansion of the tubular graft member.

28. A method for making a structurally supported graft comprising the steps of:

a) providing at least one structural support member having a plurality of longitudinally deformable inelastic strain relief sections;

b) circumferentially coupling the covered structural support member with a tubular graft member.

29. The method of claim 28, further including the step of co-extruding the at least one structural support member with a covering.

30. The method of claim 28, further including the step of encapsulating the at least one structural support member between at least two concentrically bound tubular graft members.

31. The method of claim 28, further including the step of removing sections of covering adjacent the plurality of longitudinally deformable strain relief sections prior to the co-extruding step.

32. A method for making a structurally supported graft comprising the steps of:

a) providing a structural support member having a plurality of longitudinally deformable inelastic strain relief sections which permit longitudinal expansion of the structural support member under the influence of a longitudinally oriented load; and

b) attaching the structural support member to a tubular graft member such that the plurality of strain relief sections are capable of longitudinal expansion under the influence of a longitudinally oriented load applied to the structural support member.