Paravalvular Leak Resistant Prosthetic Heart Valve System

• US 20150305860A1
• Filed: 04/23/2014
• Published: 10/29/2015
• Est. Priority Date: 04/23/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: McKinley, Laura, Wong, Benjamin, Wang, Will, Dudney, Joshua, Garde, Kshitija P.
• Granted Patent: US 10,321,987 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0061 swellable
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 1/00 Compositions of cellulose, modified cellulose or cellulose derivatives

Abstract

A paravalvular leak resistant prosthetic heart valve system including a stent frame, a valve structure and a sealing mechanism. The stent frame has a surface. The valve structure is associated with the stent frame. The sealing mechanism at least partially extends over the surface of the stent frame. The sealing mechanism includes at least one semi-permeable membrane and an osmotic gradient driving material.

Claims

1. A paravalvular leak resistant prosthetic heart valve system comprising:

a stent frame having a surface;

a valve structure associated with the stent frame; and

a sealing mechanism at least partially extends over the surface of the stent frame, wherein the sealing mechanism comprises;

at least one semi-permeable membrane; and

at least one osmotic gradient driving material.

2. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the at least one osmotic gradient driving material is substantially sealed within the at least one semi-permeable membrane.

3. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the at least one semi-permeable membrane comprises two semi-permeable membranes and wherein the at least one osmotic gradient driving material is placed between the two semi-permeable membranes.

4. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the at least one osmotic gradient driving material comprises at least one organic or inorganic compound that is positively or negatively charged.

5. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the at least one osmotic gradient driving material comprises at least one inorganic salt and at least one charged organic compound.

6. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the at least one osmotic gradient driving material is provided in at least one of particulate form and a sheet form.

7. The paravalvular leak resistant prosthetic heart valve system of claim 1, and further comprising a dissolvable coating layer on the at least one semi-permeable membrane.

8. The paravalvular leak resistant prosthetic heart valve system of claim 7, wherein the dissolvable coating layer dissolves upon exposure to at least one of blood and a solvent.

9. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the at least one semi-permeable membrane is fabricated from a cellulosic material.

10. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the sealing mechanism is secured to the stent frame by at least one of a mechanical fastener and a biocompatible adhesive.

11. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein the stent frame is expandable from a compressed configuration to an expanded configuration and wherein the valve structure comprises at least two leaflets.

12. A method of reducing paravalvular leakage from a prosthetic heart valve, wherein the method comprises:

providing a prosthetic heart valve comprising a stent frame having a surface, a valve structure associated with the stent frame, a sealing mechanism comprising at least one semi-permeable membrane and at least one osmotic material driving compound, wherein the sealing mechanism is positioned at least partially over the surface of the stent frame; and

deploying the prosthetic heart valve in a patient, wherein the osmotic gradient driving material causes fluid of the patient to pass through the at least one semi-permeable membrane, wherein the fluid that passes through the at least one semi-permeable membrane causes the sealing mechanism to swell and such swelling reduces paravalvular leakage between the prosthetic heart valve and tissue of the patient.

13. The method of claim 12, and further comprising substantially sealing the osmotic gradient driving material within the at least one semi-permeable membrane.

14. The method of claim 12, wherein the at least one semi-permeable membrane comprises two semi-permeable membranes and wherein the osmotic gradient driving material is placed between the two semi-permeable membranes.

15. The method of claim 12, wherein the osmotic gradient driving material comprises at least one organic or inorganic compound that is positively or negatively charged.

16. The method of claim 12, wherein the osmotic gradient driving material comprises at least one inorganic salt and at least one charged organic compound.

17. The method of claim 12, wherein the prosthetic heart valve further comprises a dissolvable coating layer on the at least one semi-permeable membrane wherein the method further comprises:

exposing the dissolvable coating layer to at least one of blood and a solvent; and

dissolving the dissolvable coating layer.

18. The method of claim 12, wherein the at least one semi-permeable membrane is fabricated from a cellulosic material.

19. The method of claim 12, and further comprising securing the sealing mechanism to the stent frame by at least one of a mechanical fastener and a biocompatible adhesive.

20. The method of claim 12, wherein the stent frame is expandable from a compressed configuration to an expanded configuration and wherein the valve structure comprises at least two leaflets.