Device for implantation in the heart of a mammal

• US 10,028,821 B2
• Filed: 04/03/2015
• Issued: 07/24/2018
• 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
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US14/678,376
• Publication Number:
  US 20150282958A1
• Time in Patent Office: 1,208 Days
• 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 includes 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. 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, so dimensioned as to be implantable within the superior vena cava, and having a length, a diameter, a first end and a second end, wherein the first tubular stent member does not comprise a covering on an interior of the first tubular stent member or an exterior of the first tubular stent member,

a second tubular stent member, so dimensioned as to be implantable within the inferior vena cava, and having a length, a diameter, a first end and a second end, wherein the said second tubular stent member does not comprise a covering on an interior of the second tubular stent member or an exterior of the second tubular stent member,

a tubular stent graft member, having a length, a diameter, a first stent graft member end, a second stent graft member end, and an opening along the length, and comprising a covering being attached to a stent element, wherein the tubular stent graft member is fixedly assembled between the first tubular stent member and the second tubular stent member, such, that the second stent graft member end is attached to the first tubular stent member'"'"'s first end, and the first stent graft member end is attached to the second tubular stent member'"'"'s second end, wherein the tubular stent graft member is so dimensioned as to be implantable 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 stent element of the stented valve member is fixedly mounted on the stent element of the tubular stent graft member such that the stent element of the stented valve member is sized and fitted to align with the opening of the tubular stent graft member, wherein the stented valve member is unidirectional, allowing blood to flow from the vena cava into the right atrium in a direction generally perpendicular to the lumen while blocking the blood flow in an opposite direction, wherein the stented valve member comprises a material that is selected from animal pericardium or from native leaflets from a human heart or veins, and wherein the valve is configured to function as a tricuspid valve of a human heart, to prevent regurgitation of a natural tricuspid valve when implanted.

2. The device of claim 1, further comprising visualization elements, preferably radio-opaque markers, wherein the visualization elements are attached to the device at one or more of the following sites of the device:

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

3. The device of claim 2, wherein the visualization elements are radio-opaque markers.

4. The device of claim 1, wherein at least one of the first tubular stent member, the second tubular stent member, the stent element of the tubular 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.

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

6. The device of claim 1, wherein the diameter of the first tubular stent member is, in the expanded state of the device, smaller than the diameter of the second tubular stent member.

7. The device of claim 1, wherein the diameter of the first tubular stent member, the second tubular stent member or the tubular stent graft member, vary along the respective length of the first tubular stent member, the second tubular stent member, or the tubular stent graft member.

8. The device of claim 1, wherein the valve is biocompatible and comprises one, two or three leaflets.

9. The device of claim 1, wherein the valve comprises an animal pericardium material that is selected from porcine, bovine, or equine pericardium.

10. The device of claim 1, wherein the covering of the tubular 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 and copolymers thereof.

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

12. The device of claim 1, wherein the stent element of the tubular stent graft member is fixedly assembled between the first tubular stent member and the second tubular stent member.

13. 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 11, wherein the device is surgically implanted.

15. The method of claim 14, wherein the method, comprises the following steps:

loading the device onto a deployment catheter, and, thereupon, holding the device 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.

16. The method of claim 14, wherein the method, comprises the following steps:

loading the device onto a deployment catheter, and, thereupon, holding the device 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.

17. The method of claim 11, wherein the device is delivered by transcatheter methods.

18. 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, so dimensioned as to be implantable within the superior vena cava, and having a length, a diameter, a first end and a second end, wherein the first tubular stent member does not comprise a covering on an interior of the first tubular stent member or an exterior of the first tubular stent member,

a second tubular stent member, so dimensioned as to be implantable within the inferior vena cava, and having a length, a diameter, a first end and a second end, wherein the said second tubular stent member does not comprise a covering on an interior of the second tubular stent member or an exterior of the second tubular stent member,

a tubular stent graft member, having a length, a diameter, a first stent graft member end 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 tubular stent member and the second tubular stent member, such, that the second stent graft member end is attached to the first tubular stent member'"'"'s first end, and the first stent graft member end is attached to the second tubular stent member'"'"'s second end, wherein the tubular stent graft member is so dimensioned as to be implantable within the right atrium of the mammal'"'"'s heart;

and

an annular stented valve member comprising a stent element and a valve, the valve being mounted on the stent element, wherein the annular stented valve member is fixedly mounted on the tubular stent graft member so as to project outwardly from and generally perpendicular to the lumen, wherein the annular stented valve member is unidirectional, allowing blood to flow from the vena cava into the right atrium while blocking the blood flow in an opposite direction, wherein the annular stented valve member comprises a material that is selected from animal pericardium or from native leaflets from a human heart or veins, and wherein the valve is configured to function as a tricuspid valve of a human heart, to prevent regurgitation of a natural tricuspid valve when implanted.