COMPOSITE PROSTHESIS WITH EXTERNAL POLYMERIC SUPPORT STRUCTURE AND METHODS OF MANUFACTURING THE SAME

• US 20110288628A1
• Filed: 05/20/2010
• Published: 11/24/2011
• Est. Priority Date: 05/20/2010
• Status: Active Grant

• Current Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Original Assignee: Maquet Cardiovascular LLC (Getinge AB)
• Inventors: Noesner, Matthew, Dong, Jerry
• Granted Patent: US 8,696,738 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• 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 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0046 differing in melting temperature
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29C 66/006 Preventing damaging, e.g. of the parts to be joined B29C66/003, B29C66/004, B29C66/348 take precedence
• CPC Class Codes: B29C 66/532 Joining single elements to the wall of tubular articles, hollow articles or bars
• CPC Class Codes: B29C 66/712 the composition of one of the parts to be joined being different from the composition of the other part
• CPC Class Codes: B29C 66/723 being multi-layered B29C66/7292, B29C66/72941 take precedence
• CPC Class Codes: B29C 66/729 Textile or other fibrous material made from plastics
• CPC Class Codes: B29K 2623/12 PP, i.e. polypropylene
• CPC Class Codes: B29K 2713/00 Use of textile products or fabrics for preformed parts, e.g. for inserts B29K2105/06 takes precedence
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A prosthesis including a support structure for enhancing kink and/or crush resistance. The support structure is connected to an outer surface of the prosthesis and includes at least two components, one of which has a lower melting point than the other. The component with the lower melting point is used to connect the support structure to the outer surface of the prosthesis.

Claims

1. An implantable prosthesis comprising:

(a) a generally tubular body comprising an outer textile surface; and

(b) a support structure attached to the outer textile surface of the body and configured to increase at least one of the kink and crush resistance of the body,

the support structure comprising a first component and a second component,

the second component (i) comprising a polymeric material, (ii) having a lower melting temperature than that of the first component and the body, and (iii) connecting the first component to the body.

2. The implantable prosthesis of claim 1, wherein the body of the implantable prosthesis comprises an inner layer made from a biocompatible polymer.

3. The implantable prosthesis of claim 2, wherein the outer textile surface is the outer surface of an outer textile layer comprising filaments or yarns with interstices or pores between them, wherein the second component extends into the interstices or pores and thereby mechanically connects the first component of the support structure to the outer textile layer.

4. The implantable prosthesis of claim 3, wherein the outer textile layer comprises a knit, woven or braid pattern of the filaments or yarns and wherein the second component of the support structure is removably connected to the outer textile layer such that removal of the first component does not substantially damage the knit or woven pattern.

5. The implantable prosthesis of claim 2, wherein the support structure is configured such that removal of the first component from the outer textile layer removes a portion of the second component while leaving a remainder of the second component connected to the outer textile layer.

6. The implantable prosthesis of claim 2, wherein a biocompatible elastomeric bonding agent bonds an outer surface of the inner layer to an inner surface of the outer textile layer.

7. The implantable prosthesis of claim 1, wherein the first component has a melting temperature of approximately 130°

C.-170°

C. and the second component has a melting temperature of approximately 60°

C.-105°

C.

8. The implantable prosthesis of claim 1, wherein the first component is made from polypropylene.

9. The implantable prosthesis of claim 1, wherein the second component is made from polyethylene.

10. The implantable prosthesis of claim 1, wherein the support structure is wrapped about the outer textile surface.

11. The implantable prosthesis of claim 2, wherein the inner layer is made from at least one of ePTFE, polyurethane, silicone, and an acrylate.

12. The implantable prosthesis of claim 2, wherein the inner layer is made from ePTFE.

13. The implantable prosthesis of claim 1 wherein the second component is disposed about the first component.

14. A method of preparing an implantable prosthesis comprising:

(a) applying a support structure to an outer textile surface of a generally tubular body of the prosthesis, the support structure comprising a first component and a second component disposed about the first component, the second component being polymeric and having a lower melting temperature than that of the first component and the body;

(b) melting the second component, and not the first component or the body, so as to cause the second component to connect the first component to the body.

15. The method of claim 14 further comprising the preliminary steps of forming the body by disposing a textile outer layer over a biocompatible polymeric inner layer and connecting the outer and inner layers using a biocompatible elastomeric bonding agent.

16. The method of claim 14, wherein the melting is accomplished by raising the temperature of the second component to between approximately 60°

C. and 105°

C.

17. The method of claim 14, wherein the first component is made from polypropylene.

18. The method of claim 14, wherein the second component is made from polyethylene.

19. The method of claim 14, wherein the support structure is applied to the body such that it is helically wrapped around the body.

20. The method of claim 14, wherein the inner layer is made from at least one of ePTFE, polyurethane, silicone and acrylates.

21. The method of claim 14 further comprising the steps of determining an appropriate size of the prosthesis for implantation into a subject and removing the first component from at least one end of the prosthesis consistent with the appropriate size while leaving the support structure connected along a remainder of the body.

22. A method of implanting a prosthesis into a subject comprising the steps of:

(a) determining an appropriate size of the prosthesis for the subject, the prosthesis comprising a generally tubular body and a support structure attached to an outer surface of the body and configured to increase at least one of the kink and crush resistance of the body,

the support structure comprising a first component and a second component, the second component having a lower melting temperature than that of the first component and the body, the second component connecting the first component to the body;

(b) removing the first component from at least one end of the prosthesis consistent with the appropriate size while leaving the support structure connected along a remainder of the body; and

(c) implanting the prosthesis in the subject.

23. The method of claim 22, wherein the body comprises an inner polymeric layer and an outer textile layer.

24. The method of claim 22, wherein the first component is made from polypropylene.

25. The method of claim 22, wherein the second component is made from polyethylene.