Mitral valve prosthesis

• US 10,441,423 B2
• Filed: 02/27/2017
• Issued: 10/15/2019
• Est. Priority Date: 06/01/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hauser, David L., Solem, Jan Otto, Alon, David
• Primary Examiner(s): Orkin, Alexander J
• Application Number:
  US15/443,289
• Publication Number:
  US 20170165055A1
• Time in Patent Office: 960 Days
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2002/0835 with deformation of anchor parts, e.g. expansion of dowel by set screw
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

A prosthetic device for treating a mitral valve includes a prosthetic insert member insertable between leaflets of mitral valve. The insert member has an elongated cross-sectional profile for conforming to gap between leaflets of a mitral valve. The device also includes an anchoring member for attachment to heart tissue for maintaining the insert member in the mitral valve. The insert member includes a valve that permits one-way blood flow therethrough. An anchoring member secures the prosthetic insert member to a heart wall.

Claims

1. A prosthetic device for a mitral valve comprising:

a longitudinal axis;

an insert member including an inner support layer and an outer layer, the inner support layer comprising a shape-memory metal, the outer layer comprising fabric,

an inflow end, and an outflow end, the longitudinal axis passing through the inflow end and the outflow end,

a passageway extending through the insert member along the longitudinal axis, and

a one-way valve disposed within the passageway, the one-way valve including one or more flaps, the one-way valve permitting blood flow from the inflow end to outflow end, wherein

the insert member in the compressed state has a diameter suitable for delivery in a delivery sheath,

the insert member has an expanded state and a compressed state,

the insert member in the expanded state has a cross-sectional profile transverse to the longitudinal axis in which sides of the insert member are shaped for creating a tight seal against native mitral valve leaflets, the insert member in the expanded state sufficiently rigid to substantially maintain a shape thereof; and

an anchoring member extending longitudinally from the insert member, the anchoring member including a proximal end portion and a distal end portion, the proximal end portion coupled to the insert member, the distal end portion of the anchoring member including a self-expanding, flower-shaped anchor having a compressed configuration and an expanded configuration, the flower-shaped anchor suitable for anchoring to a left ventricular wall.

2. The prosthetic device of claim 1, wherein the flower-shaped anchor includes a plurality of elongated prongs.

3. A system comprising the prosthetic device of claim 1 and a delivery catheter, the prosthetic device with the insert member in the compressed state receivable in a lumen of the delivery catheter.

4. A prosthetic device for a mitral valve comprising:

a longitudinal axis;

an insert member including an inner support layer and an outer layer, the inner support layer comprising a shape-memory metal, the outer layer comprising fabric,

an inflow end, and an outflow end, the longitudinal axis passing through the inflow end and the outflow end,

a passageway extending through the insert member along the longitudinal axis, and

a one-way valve disposed within the passageway, the one-way valve including one or more flaps, the one-way valve permitting blood flow from the inflow end to outflow end, wherein

the insert member in the compressed state has a diameter suitable for delivery in a delivery sheath,

the insert member has an expanded state and a compressed state,

the insert member in the expanded state has a cross-sectional profile transverse to the longitudinal axis in which sides of the insert member are shaped for creating a tight seal against native mitral valve leaflets, the insert member in the expanded state sufficiently rigid to substantially maintain a shape thereof; and

an anchoring member extending longitudinally from the insert member, the anchoring member including a proximal end portion and a distal end portion, the proximal end portion coupled to the insert member, the distal end portion of the anchoring member comprising a penetration member including an elongated body portion suitable for penetrating through the left ventricular wall.

5. The prosthetic device of claim 4, wherein the anchoring member further comprises at least one plate, the at least one plate engageable with the penetration member for securing the penetration member to the heart.

6. A system comprising the prosthetic device of claim 4 and a delivery catheter, the prosthetic device with the insert member in the compressed state receivable in a lumen of the delivery catheter.

7. A prosthetic device for a mitral valve comprising:

a longitudinal axis;

an insert member including an inner support layer and an outer layer, the inner support layer comprising metal, the outer layer comprising fabric or biological material,

an inflow end, and an outflow end, the longitudinal axis passing through the inflow end and the outflow end,

a passageway extending through the insert member along the longitudinal axis, and

a one-way valve disposed within the passageway, the one-way valve including one or more flaps, the one-way valve permitting blood flow from the inflow end to outflow end, wherein

the insert member in the compressed state has a diameter suitable for delivery in a delivery sheath,

the insert member has an expanded state and a compressed state,

the insert member in the expanded state has a cross-sectional profile transverse to the longitudinal axis in which sides of the insert member are shaped for creating a tight seal against native mitral valve leaflets, the insert member in the expanded state sufficiently rigid to substantially maintain a shape thereof; and

an anchoring member extending longitudinally from the insert member, the anchoring member including a proximal end portion and a distal end portion, the proximal end portion coupled to the insert member, the distal end portion of the anchoring member suitable for anchoring to a left ventricular wall.

8. The prosthetic device of claim 7, wherein the insert member comprises a shape memory metal.

9. The prosthetic device of claim 7, wherein the cross-sectional profile of the insert member has a crescent shape.

10. The prosthetic device of claim 7, wherein the outer layer is disposed over selected portions of an outer surface of the inner layer.

11. The prosthetic device of claim 7, wherein the distal end portion of the anchoring member comprises a self-expanding, flower-shaped anchor having a compressed configuration and an expanded configuration.

12. The prosthetic device of claim 11, wherein the flower-shaped anchor includes a plurality of elongated prongs.

13. The prosthetic device of claim 11, wherein each prong comprises a self-curving area that deflects the prongs radially outward from a center of the body and towards the proximal end of the anchor member.

14. The prosthetic device of claim 11, wherein the self-expanding anchor comprises nitinol.

15. The prosthetic device of claim 7, wherein the distal end portion of the anchoring member comprises a penetration member including an elongated body portion suitable for penetrating through the left ventricular wall.

16. The prosthetic device of claim 15, wherein the anchoring member further comprises at least one plate, the at least one plate engageable with the penetration member for securing the penetration member to the heart.

17. The prosthetic device of claim 15, wherein penetration member comprises a biocompatible metal or a biocompatible plastic.

18. A system comprising the prosthetic device of claim 7 and a delivery catheter, the prosthetic device with the insert member in the compressed state receivable in a lumen of the delivery catheter.

19. The system of claim 18, wherein the catheter is dimensioned for insertion at a femoral artery or an iliac artery.

20. The system of claim 18, wherein the catheter is dimensioned for insertion at an apex of the heart.