Bifurcated tubular graft for treating tricuspid regurgitation

• US 10,130,465 B2
• Filed: 02/23/2016
• Issued: 11/20/2018
• Est. Priority Date: 02/23/2016
• Status: Active Grant

• Current Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Cardiovascular Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wei, Michael Francis
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/051,045
• Publication Number:
  US 20170239043A1
• Time in Patent Office: 1,001 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2230/006 Y-shaped

Abstract

A lubricated tubular graft is implanted in the inferior vena cava and the superior vena cava in order to control the inflow of blood to the right atrium. A bifurcated leg with a non-collapsing stent extends across the tricuspid valve. A bioprosthetic valve is positioned proximal of the stent in the bifurcated leg in order to regulate flow through the tricuspid valve and to eliminate tricuspid regurgitation.

Claims

1. A medical device for treating tricuspid valve regurgitation, comprising:

a bifurcated endograft having a Y-shaped configuration including a first leg, a second leg and a third leg all in fluid communication;

the first leg having a first length and being configured for extending into the superior vena cava (SVC) and a first stent adjacent a distal end of the first leg for attaching the first leg to the SVC;

the second leg having a second length and being configured for extending into the inferior vena cava (IVC) and a second stent adjacent a distal end of the second leg for attaching the second leg to the IVC;

the third leg having a third length and being configured for extending into the right atrium and through the tricuspid valve;

the third leg having a third stent adjacent a distal end of the third leg to hold open the tricuspid valve; and

a bioprosthetic valve positioned in the third leg and spaced proximal to the third stent a distance in the range from 0.0394 in. to 1.1811 in. (1.0 mm to 30.0 mm) wherein the bioprosthetic valve does not contact the third stent.

2. The medical device of claim 1, wherein the bioprosthetic valve is positioned in the third leg and spaced proximal to the third stent a distance in the range from 0.1969 in. to 0.7874 in. (5.0 mm to 20.0 mm).

3. The medical device of claim 1, wherein the bioprosthetic valve is positioned in the third leg and spaced proximal to the third stent a distance in the range from 0.0394 in. to 0.3937 in. (1.0 mm to 10.0 mm).

4. The medical device of claim 1, wherein the third stent has a non-collapsing lattice structure in order to hold open the tricuspid valve.

5. The medical device of claim 1, wherein the bifurcated endograft is formed from PTFE, ePTFE, polyester, urethane, polyethylene terephthalate, polytetrafluoroethylene, or other distensible polymeric material.

6. The medical device of claim 1, wherein the first stent, second stent and third stent are balloon expandable and plastically deform when expanded.

7. A medical device for treating tricuspid valve regurgitation, comprising:

a tubular graft having a Y-shaped configuration including a tubular main body and a tubular leg portion extending from the tubular main body and being in fluid communication;

the tubular main body having first end extending into the superior vena cava (SVC) and a first stent adjacent a first end for attaching the tubular main body to the SVC;

the tubular main body having a second end extending into the inferior vena cava (IVC) and a second stent adjacent a second end for attaching the tubular main body to the IVC;

the tubular leg portion being configured for extending into the right atrium and through the tricuspid valve;

the tubular leg portion having a third stent adjacent a distal end of the tubular leg portion to hold open the tricuspid valve; and

a bioprosthetic valve positioned in the tubular leg portion and spaced proximal to the third stent a distance in the range from 0.0394 in. to 1.1811 in. (1.0 mm to 30.0 mm) wherein the bioprosthetic valve does not contact the third stent.

8. The medical device of claim 7, wherein the bioprosthetic valve is positioned in the tubular leg portion and spaced proximal to the third stent a distance in the range from 0.1969 in. to 0.7874 in. (5.0 mm to 20.0 mm).

9. The medical device of claim 7, wherein the bioprosthetic valve is positioned in the tubular leg portion and spaced proximal to the third stent a distance in the range from 0.0394 in. to 0.3937 in. (1.0 mm to 10.0 mm).

10. The medical device of claim 7, wherein the third stent has a non-collapsing lattice structure in order to hold open the tricuspid valve.

11. The medical device of claim 7, wherein the bifurcated endograft is formed from PTFE, ePTFE, polyester, urethane, polyethylene terephthalate, polytetrafluoroethylene, or other distensible polymeric material.

12. The medical device of claim 7, wherein the first stent, second stent and third stent are balloon expandable and plastically deform when expanded.

13. A medical device for treating tricuspid valve regurgitation, comprising:

a bifurcated endograft having a Y-shaped configuration including a first leg, a second leg and a third leg all in fluid communication;

the first leg having a first length and being configured for extending into the superior vena cava (SVC) and a first stent adjacent a distal end of the first leg for attaching the first leg to the SVC;

the second leg having a second length and being configured for extending into the inferior vena cava (IVC) and a second stent adjacent a distal end of the second leg for attaching the second leg to the IVC;

the third leg having a third length and being configured for extending into the right atrium and through the tricuspid valve;

the third leg having a third stent adjacent a distal end of the third leg to hold open the tricuspid valve; and

a bioprosthetic valve positioned in the third leg proximal to the third stent wherein the bioprosthetic valve abuts the third stent but does not extend into the third stent.

14. The medical device of claim 13, wherein the third stent has a non-collapsing lattice structure in order to hold open the tricuspid valve.

15. The medical device of claim 13, wherein the bifurcated endograft is formed from PTFE, ePTFE, polyester, urethane, polyethylene terephthalate, polytetrafluoroethylene, or other distensible polymeric material.

16. The medical device of claim 13, wherein the first stent, second stent and third stent are balloon expandable and plastically deform when expanded.