Low bleed implantable prosthesis with a taper

• US 10,357,385 B2
• Filed: 06/03/2016
• Issued: 07/23/2019
• Est. Priority Date: 06/05/2015
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Schlaud, Marc A., Stringer, Timothy T.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/173,361
• Publication Number:
  US 20160354217A1
• Time in Patent Office: 1,145 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae

Abstract

A vascular graft having a sealing layer and a tapered length portion. The sealing layer provides the vascular graft with low bleed characteristics subsequent to a needle puncture such as with a dialysis needle or a suture needle. The sealing layer in the tapered length portion has varying wall thickness along the tapered length portion.

Claims

1. An implantable device comprising:

a tubular structure having a proximal end portion and a distal end portion with a distal end portion, a transition portion having a transition portion proximal end with a transition portion proximal end inside diameter, a transition portion distal end with a transition portion distal end inside diameter that is greater than the transition portion proximal end inside diameter, and a transition portion length between the transition portion proximal end and the transition portion distal end;

wherein the tubular structure has a first layer comprising a porous polymer, a second layer, and at least one intermediate layer adjacent the first layer; and

wherein the intermediate layer has a variable wall thickness extending at least partially along the transition portion length and wherein an intermediate layer wall thickness is greater within the distal end portion than the intermediate layer wall thickness within the proximal end portion.

2. The implantable device of claim 1 wherein the intermediate layer comprises an elastomer.

3. The implantable device of claim 1 wherein the tubular structure further comprises a proximal portion, and a distal portion.

4. The implantable device of claim 1 wherein the first layer is ePTFE.

5. The implantable device of claim 1 wherein the intermediate layer has an intermediate layer wall thickness at the transition portion distal end that is greater than an intermediate layer wall thickness at the transition portion proximal end.

6. The implantable device of claim 2 wherein the intermediate layer is silicone.

7. The implantable device of claim 3 wherein the distal portion has a length between the transition portion distal end and a distal portion distal end that is greater than the transition portion length and the transition portion length is greater than a proximal portion length between a proximal portion proximal end and the transition portion proximal end.

8. The implantable device of claim 1 wherein the second layer is ePTFE.

9. The implantable device of claim 1 wherein the intermediate layer wall thickness tapers from the transition portion distal end to the transition portion proximal end, and the intermediate layer wall thickness of the intermediate layer at the transition portion proximal end is zero.

10. An implantable device comprising:

a tubular structure having a first layer, an intermediate layer comprising an elastomer, a second layer, and a length between a proximal end and a distal end;

wherein said proximal end has a proximal inside diameter, and said distal end has a distal inside diameter, wherein the proximal inside diameter is less than the distal inside diameter and there is a transition portion length located between the proximal inside diameter and the distal inside diameter;

wherein the first layer and second layer comprise a porous material; and

wherein the intermediate layer has an intermediate layer wall thickness along the length of the tubular structure, wherein the intermediate layer wall thickness is greater at the distal end than it is at the proximal end.

11. The implantable device of claim 10 wherein the intermediate layer comprises silicone.

12. The implantable device of claim 10 wherein the first layer comprises ePTFE.

13. The implantable device of claim 10 wherein the second layer comprises ePTFE.

14. The implantable device of claim 10 wherein the first layer and second layer comprise ePTFE.

15. The implantable device of claim 10 wherein the first layer has a first layer wall thickness that is greater at the proximal end than at the distal end and the second layer has a second layer wall thickness that is greater at the proximal end than at the distal end.

16. The implantable device of claim 15 further comprising an overall wall thickness wherein the overall wall thickness is greater at the proximal end than at the distal end.

17. The implantable device of claim 10 further comprising a ratio of the intermediate layer wall thickness to a combination of the first layer wall thickness and the second layer wall thickness, wherein the ratio is greater than 1 at the proximal end.

18. The implantable device of claim 10 further comprising a ratio of the intermediate layer wall thickness to a combination of the first layer wall thickness and the second layer wall thickness, wherein the ratio is less than 1 at the distal end.

19. The implantable device of claim 10 wherein the intermediate layer wall thickness at the proximal end is zero.

20. An implantable device comprising:

a tubular structure having a first layer, an intermediate layer comprising an elastomer, a second layer, a proximal end portion and a distal end portion with a distal end portion diameter being greater than a proximal end portion diameter, and a length between a proximal end and a distal end;

wherein said proximal end has a proximal inside diameter, and said distal end has a distal inside diameter, wherein the proximal inside diameter is less than the distal inside diameter and there is a transition portion length located between the proximal inside diameter and the distal inside diameter;

wherein the first layer and second layer comprise a porous material; and

wherein the intermediate layer has an intermediate layer wall thickness along the length of the tubular structure, wherein the intermediate layer wall thickness decreases in thickness as one of the first layer and the second layer increases in thickness and wherein the intermediate layer wall thickness is greater within the distal end portion than the intermediate layer wall thickness within the proximal end portion.