STENT-GRAFT PROSTHESIS AND METHOD OF MANUFACTURE

• US 20170296325A1
• Filed: 04/18/2016
• Published: 10/19/2017
• Est. Priority Date: 04/18/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Marrocco, Joseph, Haggard, Mathew, Perkins, Keith
• Granted Patent: US 10,010,403 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• 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 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

A stent-graft prosthesis includes a generally tubular outer PTFE layer, a generally tubular helical stent, a generally tubular inner PTFE layer, and a suture or fabric support strip. The outer PTFE layer defines an outer layer lumen. The helical stent is disposed within the outer layer lumen and defines a stent lumen. The inner PTFE layer is disposed within the stent lumen and defines an inner layer lumen. The suture includes a suture first end coupled to a stent first end and a suture second end coupled to a stent second end, with the suture disposed between the outer PTFE layer and the inner PTFE layer. Alternatively, the fabric support strip is disposed between the outer and inner PTFE layers. The suture or fabric support strip may include a plurality of sutures or fabric support strips and may be spaced equally around a circumference of the inner PTFE layer.

Claims

1. :

A stent-graft prosthesis comprising;

a generally tubular outer PTFE layer, the outer PTFE layer defining an outer layer lumen therein;

a generally tubular helical stent disposed within the outer layer lumen, the helical stent assembly including a stent first end and a stent second end, and defining a stent lumen therein;

a generally tubular inner PTFE layer disposed within the stent lumen defining an inner layer, therein; and

a suture having a suture first end coupled to the stent first end and a suture second end coupled to the stent second end, wherein the suture is disposed between the outer PTFE layer and the inner PTFE layer.

2. :

The stent-graft prosthesis of claim 1, wherein the suture comprises a plurality of sutures.

3. :

The stent-graft prosthesis of claim 2, where in the plurality of sutures are spaced equally around a circumference of the inner PTFE layer.

4. :

The stent-graft prosthesis of claim 1, wherein the suture is disposed between the inner PTFE layer and the helical stent.

5. :

The stent-graft prosthesis of claim 1, wherein the suture is disposed between the outer PTFE layer and the helical stent.

6. :

The stent-graft prosthesis of claim 1, wherein the suture is woven over and under the helical stent and is disposed between the inner PTFE layer and the outer PTFE layer.

7. :

The stent-graft prosthesis of claim 1, wherein the suture extends generally longitudinally.

8. :

A stent-graft prosthesis comprising;

a generally tubular outer PTFE layer defining an outer layer lumen therein;

a generally tubular helical stent disposed within the outer layer lumen and defining a stent lumen therein;

a generally tubular inner PTFE layer disposed within the stent lumen, the inner PTFE layer including a generally tubular shape, a first end and a second end, and defining a central passage and a central axis; and

a fabric support strip encapsulated between the outer PTFE layer and the inner PTFE layer, the fabric support strip extending generally longitudinally from a first end of the stent-graft prosthesis to a second end of the stent-graft prosthesis.

9. :

The stent-graft prosthesis of claim 8, wherein the fabric support strip comprises a plurality of fabric support strips.

10. :

The stent-graft prosthesis of claim 8, wherein the fabric support strip is disposed between the inner PTFE layer and the helical stent.

11. :

The stent-graft prosthesis of claim 8, wherein the fabric support strip is disposed between the helical stent and the outer PTFE layer.

12. :

The stent-graft prosthesis of claim 8, wherein the fabric support strip is a mesh fabric and includes a plurality of openings therethrough, and wherein the inner PTFE layer is bonded to the outer PTFE layer through the plurality of openings.

13. :

The stent-graft prosthesis of claim 8, wherein the fabric support strip includes a biologically or pharmacologically active substance.

14. :

The stent-graft prosthesis of claim 13, wherein the biologically or pharmacologically active substance is an antithrombogenic substance.

15. :

The stent-graft prosthesis of claim 13, wherein the biologically or pharmacologically active substance is configured to increase endothelialization.

16. :

The stent-graft prosthesis of claim 13, wherein the biologically or pharmacologically active substance is selected from the group consisting of antineoplastic, antimitotic, antiinflammatory, antiplatelet, anticoagulant, anti fibrin, antithrombin, antiproliferative, antibiotic, antioxidant, and antiallergic substances as well as combinations thereof.

17. :

A method of manufacturing a stent-graft prosthesis for implantation within a blood vessel, the method comprising the steps of;

positioning an inner PTFE layer over a mandrel;

coupling a first end of a suture to a first end of a helical stent and a second end of the suture to a second end of the helical stent;

positioning the helical stent onto the inner PTFE layer;

positioning an outer PTFE layer over the helical stent and the inner PTFE layer;

positioning a heat shrink material over the outer PTFE layer, wherein the heat shrink material fully covers the inner and outer PTFE layers;

heating the inner and outer PTFE layers to couple together the inner and outer PTFE layers such that the inner PTFE layer, the helical stent, the suture, and the outer PTFE layer form the stent-graft prosthesis;

removing the heat shrink material; and

removing the stent-graft prosthesis from the mandrel.

18. :

The method of claim 17, wherein the step of coupling the suture to the helical stent comprises coupling a plurality of sutures to the helical stent.

19. :

A method of manufacturing a stent-graft prosthesis for implantation within a blood vessel, the method comprising the steps of;

positioning an inner PTFE layer over a mandrel;

positioning a helical stent onto the inner PTFE layer;

positioning a fabric support strip over the inner PTFE layer;

positioning an outer PTFE layer over the fabric support strip, the helical stent, and the inner PTFE layer;

positioning a heat shrink material over the outer PTFE layer, wherein the heat shrink material fully covers the inner and outer PTFE layers;

heating the inner and outer PTFE layers to couple together the inner and outer PTFE layers such that the inner PTFE layer, the helical stent, the fabric support strip, and the outer PTFE layer form the stent-graft prosthesis;

removing the heat shrink material; and

removing the stent-graft prosthesis from the mandrel.

20. :

The method of claim 19, wherein the fabric support strip includes a plurality of fabric support strip.