Composite prosthesis with external polymeric support structure and methods of manufacturing the same

Patent metadata

Field	Value
Publication number	US-9375326-B2
Application number	US-201414252710-A
Country	US
Kind code	B2
Filing date	Apr 14, 2014
Priority date	May 20, 2010
Publication date	Jun 28, 2016
Grant date	Jun 28, 2016

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.

First claim

What is claimed is:

1. 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; and
(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 such that the connection between the second component and the outer textile surface withstands a predetermined pulling force of about 10 grams to 300 grams and such that integrity of the outer textile surface is preserved upon removal of the first component from the body.

2. The method of claim 1 , 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.

3. The method of claim 2 , wherein the inner layer is made from at least one of ePTFE, polyurethane, silicone and acrylates.

4. The method of claim 1 , wherein the melting is accomplished by raising the temperature of the second component to between approximately 60° C. and 105° C.

5. The method of claim 1 , wherein the first component is made from polypropylene and/or the second component is made from polyethylene.

6. The method of claim 1 , wherein the support structure is applied to the body such that it is helically wrapped around the body.

7. The method of claim 1 , 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.

8. The method of claim 1 , further comprising the step of positioning the support structure about the outer textile surface to increase at least one of kink resistance and crush resistance of the body.

9. The method of claim 1 , wherein the step of melting the second component to the body further comprises positioning the support structure about the body under tension and exposing the wrapped support structure to heat.

10. 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, wherein the connection between the second component and the body withstands a predetermined pulling force of about 10 grams to 300 grams;
(b) removing an appropriate length of the first component from at least one end of the prosthesis without substantially damaging the body so as to appropriately size the prosthesis for the subject while leaving the support structure connected along a remainder of the body; and
(c) implanting the prosthesis in the subject.

11. The method of claim 10 , wherein the body comprises an inner polymeric layer comprising ePTFE and an outer textile layer.

12. The method of claim 10 , wherein the first component is made from polypropylene and/or the second component is made from polyethylene.

13. 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 comprising a polymeric material and a second component connecting the first component to the body, the second component comprising a polymeric material different than that of the first component; and
(b) attaching the support structure to the body such that the connection between the second component and the outer textile surface withstands a predetermined pulling force and so as to allow safe removal of a portion of the first component and a portion of the second component from the body to facilitate cutting the prosthesis to a desired length or customizing a location of the support structure.

14. The method of claim 13 , wherein the step of attaching the support structure to the body further comprises wrapping the support structure about the body under tension and exposing the wrapped support structure to heat such that the predetermined pulling force of about 10 grams to 300 grams.

15. The method of claim 14 , wherein the step of heating the support structure wrapped about the body under tension comprise heating the support structure at 140° C.

16. The method of claim 13 , further comprising the step of positioning the support structure about the outer textile surface to increase at least one of kink resistance and crush resistance of the body.

17. The method of claim 13 further comprising forming the body by disposing a textile outer layer over a biocompatible polymeric inner layer and connecting the outer and inner layers.

18. The method of claim 17 , wherein the step of forming the body further comprise connecting the outer and inner layers using a biocompatible elastomeric bonding agent.

19. The method of claim 18 , wherein the inner layer comprises ePTFE.

20. The method of claim 13 , wherein the first component is made from polypropylene and/or the second component is made from polyethylene.

Assignees

• Maquet Cardiovascular Llc

Inventors

• Noesner Matthew
• Dong Jerry

Classifications

• A61F2/82 Primary

  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) · CPC title

• A61F2002/075

  the stent being loosely attached to the graft material, e.g. by stitching · CPC title

• A61F2210/0071

  thermoplastic · CPC title

• A61F2/89

  the wire-like elements comprising two or more adjacent rings flexibly connected by separate members · CPC title

• A61F2240/001

  Designing or manufacturing processes · CPC title