Paravalvular leak resistant prosthetic heart valve system

• US 10,321,987 B2
• Filed: 04/23/2014
• Issued: 06/18/2019
• Est. Priority Date: 04/23/2014
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wang, Wei, Dudney, Joshua, Garde, Kshitija P., McKinley, Laura, Wong, Benjamin
• Primary Examiner(s): Snow, Bruce E
• Application Number:
  US14/259,340
• Publication Number:
  US 20150305860A1
• Time in Patent Office: 1,882 Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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, wherein the sealing mechanism comprises;

two semi-permeable membranes including an inner membrane and an outer membrane, and at least one osmotic gradient driving material placed between the two semi-permeable membranes at a concentration effective to cause fluid to be automatically diffused through the semi-permeable membranes and drawn into the sealing mechanism to provide swelling of the sealing mechanism;

wherein each of the two semi-permeable membranes are made of materials having a molecular cutoff range between 1 and 1,000,000 kilodaltons;

wherein the stent frame is positioned between the inner membrane and the outer membrane.

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, wherein the at least one osmotic gradient driving material drives osmotic diffusion of fluid through the at least one semi-permeable membrane via salt gradient.

3. 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.

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 inorganic salt and at least one charged organic compound.

5. 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.

6. The paravalvular leak resistant prosthetic heart valve system of claim 1, and further comprising a dissolvable coating layer on one of the two semi-permeable membranes.

7. The paravalvular leak resistant prosthetic heart valve system of claim 6, wherein the dissolvable coating layer dissolves upon exposure to at least one of blood and a solvent.

8. The paravalvular leak resistant prosthetic heart valve system of claim 1, wherein both of the semi-permeable membranes are fabricated from a cellulosic material.

9. 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.

10. 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.