Self-healing graft material and method of use thereof

Patent metadata

Field	Value
Publication number	US-11439495-B2
Application number	US-201916545311-A
Country	US
Kind code	B2
Filing date	Aug 20, 2019
Priority date	Aug 22, 2018
Publication date	Sep 13, 2022
Grant date	Sep 13, 2022

Abstract

The present disclosure relates to a graft material including a self-healing polymer layer and to implantable medical devices including such a graft material. The invention also relates to methods of using and manufacturing such graft materials and devices. In one embodiment, the implantable medical device is a stent graft.

First claim

What is claimed is:

1. A stent graft comprising:
an expandable stent having a luminal and an abluminal surface; and
a graft disposed on at least one of the luminal and the abluminal surface;
wherein the graft comprises a first layer comprising a self-healing polymer material; and wherein the self-healing polymer is a cross-linked co-polymer of a diamine and acrylic acid having a mixture of reversible hydrogen bonds and permanent covalent crosslinks.

2. The stent-graft of claim 1 , wherein the diamine is 1,12 diaminododecane.

3. The stent-graft of claim 1 further comprising a second self-healing polymer layer, wherein the second self-healing polymer is a thermoplastic polyurethane comprising a hard segment component, a soft segment component and a chain extender component.

4. The stent-graft of claim 3 , wherein the hard segment component comprises a polymerized diisocyanate unit, wherein the diisocyanate is selected from the group consisting of isophorone diisocyanate, 4,4′-methylenebis(cyclohexyl isocyanate), 4,4′ methylenebis(phenyl isocyanate) and hexamethylene diisocyanate.

5. The stent-graft of claim 3 , wherein the soft segment component comprises polymerized polytetramethylene ether glycol.

6. The stent-graft of claim 3 , wherein the chain extender component comprises polymerized bis(4-hydroxyphenyl) disulphide.

7. The stent graft of claim 1 , wherein the graft further comprises a second layer comprising a polymer selected from the group consisting of polytetrafluoroethylene, electro-spun polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene terephthalate, polyester, polyurethane and Fluorinated ethylene propylene, and wherein the second layer is disposed on the first layer.

8. The stent graft of claim 7 , wherein the graft further comprises a third layer comprising a polymer selected from the group consisting of polytetrafluoroethylene, electro-spun polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene terephthalate, polyester, polyurethane and fluorinated ethylene propylene, wherein the first layer is disposed between the second layer and the third layer.

9. The stent-graft of claim 1 , wherein the self-healing polymer material is woven, knitted or braided, and, wherein the self-healing polymer material imbedded in a polyurethane.

10. The stent graft of claim 1 , wherein the expandable stent comprises a plurality of interconnected struts at least partially imbedded within the first layer.

11. The stent graft of claim 1 , wherein the graft comprises a plurality of stacked layers the self-healing polymer material, wherein at least one of the plurality of stacked layers is separated from another of the plurality of stacked layers by a layer comprising a polymer selected from the group consisting of polytetrafluoroethylene, electro-spun polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene terephthalate, polyester, polyurethane and fluorinated ethylene propylene.

12. A stent graft comprising a stent and graft material, the graft material comprising a first layer comprising a self-healing polymer material and a second layer comprising a polymer selected from the group consisting of polytetrafluoroethylene, electro-spun polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene terephthalate, polyester, polyurethane and fluorinated ethylene propylene, wherein the second layer is disposed on the first layer; and wherein the self-healing polymer is a cross-linked co-polymer of a diamine and acrylic acid having a mixture of reversible hydrogen bonds and permanent covalent crosslinks.

13. The stent-graft of claim 12 , wherein the diamine is 1,12 diaminododecane.

14. The stent-graft of claim 12 further comprising a second self-healing polymer layer, wherein the second self-healing polymer is a thermoplastic polyurethane comprising a hard segment component, a soft segment component and a chain extender component.

15. The stent-graft of claim 14 , wherein the hard segment component comprises a polymerized diisocyanate unit, wherein the diisocyanate is selected from the group consisting of isophorone diisocyanate, 4,4′-methylenebis(cyclohexyl isocyanate), 4,4′ methylenebis(phenyl isocyanate) and hexamethylene diisocyanate.

16. The stent-graft of claim 14 , wherein the soft segment component comprises polymerized polytetramethylene ether glycol.

17. The stent-graft of claim 14 , wherein the chain extender component comprises polymerized bis(4-hydroxyphenyl) disulphide.

18. The stent graft of claim 12 , wherein the graft further comprises a third layer comprising a polymer selected from the group consisting of polytetrafluoroethylene, electro-spun polytetrafluoroethylene, expanded polytetrafluoroethylene, polyethylene terephthalate, polyester, polyurethane and fluorinated ethylene propylene, wherein the first layer is disposed between the second layer and the third layer.

19. A stent graft comprising:
an expandable stent comprising a tubular body with a lumen extending therethrough and having a luminal and an abluminal surface; and
a graft disposed on at least one of the luminal and the abluminal surface;
wherein the graft comprises:
a first layer comprising self-healing polymer, wherein the self-healing polymer is a cross-linked co-polymer of a diamine and acrylic acid having a mixture of reversible hydrogen bonds and permanent covalent crosslinks;

a second layer comprising electro-spun polytetrafluoroethylene or expanded polytetrafluoroethylene; and
a third layer comprising electro-spun polytetrafluoroethylene or expanded polytetrafluoroethylene,
wherein the first layer is disposed between the second layer and the third layer.

Assignees

• Cook Medical Technologies Llc

Inventors

• Spindler Ralf
• Skender Davorin Kevin

Classifications

• A61F2002/072

  Encapsulated stents, e.g. wire or whole stent embedded in lining · CPC title

• C08G18/755

  and at least one isocyanate or isothiocyanate group linked to a secondary carbon atom of the cycloaliphatic ring, e.g. isophorone diisocyanate · CPC title

• C08G18/10

  Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step · CPC title

• C08G18/283

  Compounds containing ether groups, e.g. oxyalkylated monohydroxy compounds · CPC title

• A61F2/07 Primary

  Stent-grafts · CPC title