DEVICE FOR IMPLANTATION IN THE HEART OF A MAMMAL

• US 20150282958A1
• Filed: 04/03/2015
• Published: 10/08/2015
• Est. Priority Date: 04/07/2014
• Status: Active Grant

• Current Assignee: Medira AG
• Original Assignee: NVT AG (Blue Sail Medical Co., Ltd.)
• Inventors: Centola, Marcos, Kawa, Emilia, Bogenschuetz, Thomas
• Granted Patent: US 10,028,821 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

A device for implantation into the heart of a mammal and a method for treating tricuspid regurgitation using the device. The device comprises two tubular stent members separated by a stent graft member which has a functional stented valve member attached thereto allowing unidirectional blood flow from the vena cava into the right atrium.

Claims

1. A device for implantation in the heart of a mammal, with a generally tubular shape, and having a longitudinal axis, a first end and a second end, and a lumen permitting blood flow there through, wherein the device comprises;

a first tubular stent member, sized and configured for implantation within the superior vena cava, and having a length, a diameter, a first and a second end;

a second tubular stent member, sized and configured for implantation within the inferior vena cava, and having a length, a diameter, a first and a second end, wherein the said second tubular stent member does not comprise a covering;

a tubular stent graft member, having a length, a diameter, a first and a second stent graft member end, and comprising a covering being attached to a stent element, wherein the tubular stent graft member is fixedly assembled between the first and the second tubular stent members, such, that the second stent graft member end is attached to the first stent member'"'"'s first end, and the first stent graft member end is attached to the second stent member'"'"'s second end, wherein the stent graft member is sized and configured for implantation within the right atrium of the mammal'"'"'s heart; and

a stented valve member comprising a stent element and a valve, the valve being mounted on the stent element, wherein the stented valve member is fixedly mounted on the stent graft member, wherein the valve member is unidirectional, allowing blood to flow from the vena cava into the right atrium while blocking the blood flow in the opposite direction.

2. The device of claim 1, wherein said first stent member does not comprise a covering.

3. The device of claim 1, further comprising visualization elements attached to the device at one or more of the following sites of the device:

at the site where the stent graft member'"'"'s first end is attached to the second stent member'"'"'s second end, at the site where the stent graft member'"'"'s second end is attached to the first stent member'"'"'s first end, and/or at the fixation site of the stented valve member to the stent graft member.

4. The device of claim 3, wherein the visualization elements are radio-opaque markers.

5. The device of claim 1, wherein at least one of the first stent member, the second stent member, the stent element of the stent graft member, and/or the stent element of the stented valve member is/are self-expanding, and wherein the device is configured such that it is convertible from a compressed state for introducing the device into a heart of a mammal to an expanded state within the heart.

6. The device of claim 1, wherein the device, along its longitudinal axis, varies in its diameter.

7. The device of claim 1, wherein the first stent member'"'"'s diameter is, in the expanded state of the device, smaller than the second stent member'"'"'s diameter.

8. The device of claim 1, wherein the diameter of each of the first stent member, the second stent member and/or the stent graft member, vary along the respective lengths for the members.

9. The device of claim 1, wherein the valve is a biological valve comprising one, two or three leaflets.

10. The device of claim 1, wherein the biological valve comprises a material that is selected from at least one of the following:

porcine pericardium, bovine pericardium, equine pericardium, or from native leaflets from human heart or veins.

11. The device of claim 1, wherein the covering of the stent graft member comprises a material selected from at least one of the following:

polyester, polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyvinylidene fluoride, polysiloxane, polyurethane, polylactide, polyglycolide or copolymers thereof.

12. The device of claim 1, wherein at least one of the first stent member, the second stent member, the stent element of the stent graft member, and/or the stent element of the stented valve member is/are woven, braided or laser-cut.

13. A method for treating tricuspid regurgitation in a mammal, the method comprising the step of deploying, delivering or implanting the device of claim 1 in a position within the heart of a patient in need thereof in order to replace or support the native tricuspid valve of said patient.

14. The method of claim 13, wherein the device is surgically implanted.

15. The method of claim 13, wherein the device is delivered by transcatheter methods.

16. The method of claim 15, wherein the method, comprises the following steps:

loading the device onto a deployment catheter and, thereupon, holding it in a compressed state by a retractable sheath;

advancing the deployment catheter having the device loaded thereon in a compressed state, via a jugular vein into a vena cava superior into the right atrium and into the vena cava inferior of the heart of the patient, in order to place the second tubular stent member into the vena cava inferior, the stent graft member within the right atrium and the first tubular stent member into the vena cava superior; and

deploying the device in the heart of the patient by retracting the sheath in order to replace or support the native tricuspid valve of said patient.

17. The method of claim 15, wherein the method, comprises the following steps:

loading the device onto a deployment catheter and, thereupon, holding it in a compressed state by a retractable sheath;

advancing the deployment catheter having the device loaded thereon in a compressed state via a femoral vein into a vena cava inferior into the right atrium and into the vena cava superior of the heart of the patient, in order to place the first tubular stent member into the vena cava superior, the stent graft member within the right atrium and the second tubular stent member into the vena cava inferior; and

deploying the device in the heart of the patient by retracting the sheath in order to replace or support the native tricuspid valve of said patient.