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

• US 9,375,326 B2
• Filed: 04/14/2014
• Issued: 06/28/2016
• 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
• Primary Examiner(s): STEWART, ALVIN J
• Application Number:
  US14/252,710
• Publication Number:
  US 20150202061A1
• Time in Patent Office: 806 Days
• Field of Search: 623/1.32, 623/1.33, 623 15- 154, 606191-194, 606/153, 606/154, 606/157, 606/158
• US Class Current: 1/1
• 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. 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.