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

• US 9,956,069 B2
• Filed: 06/01/2016
• Issued: 05/01/2018
• 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:
  US15/170,231
• Publication Number:
  US 20160270898A1
• Time in Patent Office: 699 Days
• 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 tubular body and configured to increase at least one of kink resistance and crush resistance of the tubular body,

wherein the support structure comprises a first component made from polypropylene and a second component, wherein the first component has a melting temperature of 130°

C.-170°

C.,

wherein the second component comprises a polymeric material made from polyethylene so the second component has a melting temperature of 60°

C.-105°

C. that is a lower melting temperature than that of the first component and the body, and the second component connects the first component to the tubular body, and

wherein a portion of the first component and a portion of the second component are removable with respect to the outer textile surface without substantially compromising the outer textile surface of the tubular body.

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

3. The implantable prosthesis of claim 1, wherein the outer textile surface is an outer surface of an outer textile layer comprising filaments or yarns with interstices or pores between the filaments or yarns, 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 a biocompatible elastomeric bonding agent comprising polycarbonate urethane bonds an inner layer outer surface to an inner surface of the outer textile layer.

5. The implantable prosthesis of claim 3, wherein a connection between the support structure and the tubular body is sufficiently strong to secure the support structure to the outer textile surface when the prosthesis is positioned in a patient'"'"'s body but also allows a portion of the support structure to be safely pulled off the outer textile surface so as to allow for sizing of the prosthesis.

6. The implantable prosthesis of claim 1, wherein the outer textile layer comprises a knit, woven or braid pattern of 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 second component does not substantially damage the knit or woven pattern.

7. The implantable prosthesis of claim 6, wherein a portion of the support structure is configured to be removably attached to the outer textile layer such that removal of the portion of the first component relative to the outer textile surface removes the portion of the second component while leaving a remainder of the second component connected to the outer textile surface.

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

9. The implantable prosthesis of claim 1, wherein the second component is disposed about the first component so as to physically hold onto the first component so as to resist a pulling force up to 10 grams to 300 grams.

10. The implantable prosthesis of claim 1, wherein the support structure has a semicircle cross-section or a half moon cross-section.

11. The implantable prosthesis of claim 1, wherein the support structure is applied to the body such that the support structure is helically wrapped around the body.

12. A method of preparing the implantable prosthesis according to claim 1, wherein the method comprises the steps of:

(a) applying the support structure to the outer textile surface of the tubular body of the prosthesis so as to create a connection between the support structure and the tubular body sufficiently strong so as to secure the support structure to the outer textile surface and withstand a predetermined pulling force but also allows a portion of the support structure to be detachable with respect to the outer textile surface so as to be capable of being safely pulled off along a length of the outer textile surface to facilitate sizing the prosthesis; and

(b) melting the second component so as to cause the second component to connect the first component to the tubular body so as to physically hold onto the first component so as to resist a pulling force up to 10 grams to 300 grams, wherein the second component is melted at a temperature between 60°

C. and 105°

C.

13. The method of claim 12, further comprising the preliminary steps of forming the tubular body by disposing a textile outer layer over a biocompatible polymeric inner layer comprising ePTFE and connecting the outer and inner layers using a biocompatible elastomeric bonding agent formed from the reaction of aliphatic macroglycols and aromatic or aliphatic diisocyanates.

14. The method of claim 12, 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 tubular body without substantially damaging the outer textile surface.

15. The method of claim 12, further comprising the step of:

melting the second component so as to cause the second component to extend into the tubular body.

16. The method of claim 12, wherein the first component is not melted during the melting of the second component.