Devices, systems and methods for heart valve replacement

• US 10,702,380 B2
• Filed: 08/21/2017
• Issued: 07/07/2020
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, III, Hanson, Fann, James L., Dueri, Jean-Pierre, Gittings, Darrin, Luna, Michael, Deem, Mark, Sutton, Douglas
• Primary Examiner(s): Shi, Katherine M
• Application Number:
  US15/681,751
• Publication Number:
  US 20180014931A1
• Time in Patent Office: 1,051 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 2210/0076 multilayered, e.g. laminated structures
• 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
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

Prosthetic heart valve devices for percutaneous replacement of native heart valves and associated systems and method are disclosed herein. A prosthetic heart valve device configured in accordance with a particular embodiment of the present technology can include a valve support having an upstream end and a downstream end extending around a longitudinal axis and having a cross-sectional shape. The valve support can have an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve. The device can also include an expandable retainer coupled to the upstream end of the valve support. The retainer can be configured to engage tissue on or near the annulus. In some embodiments, the valve support is mechanically isolated from the retainer such that the cross-sectional shape of the valve support remains sufficiently stable when the retainer is deformed in a non-circular shape by engagement with the tissue.

Claims

1. A method for replacement of a native mitral valve having an annulus and a plurality of leaflets, the method comprising:

positioning a prosthetic device between the plurality of leaflets in a collapsed configuration;

allowing the prosthetic device to expand such that a retainer of the prosthetic device is in a subannular position between the plurality of leaflets in which the retainer engages tissue on or downstream of the annulus, wherein the retainer forms a ring having a diameter larger than a corresponding diameter of the annulus in the subannular position; and

allowing a valve support to expand, at least a portion of the retainer being positioned at an upstream end of the valve support;

wherein the upstream end of the valve support is radially inward from and longitudinally overlapping a portion of the retainer when the prosthetic device is in a deployed configuration; and

wherein the valve support is mechanically isolated from the retainer such that radial deformation of the retainer when engaging the tissue does not substantially deform the valve support.

2. The method of claim 1, further comprising delivering the prosthetic device by a catheter prior to positioning the prosthetic device between the plurality of leaflets.

3. The method of claim 2, further comprising retracting a sheath on the catheter to expose the prosthetic device in an expanded configuration, and moving the prosthetic device in an upstream direction such that an upstream portion of the retainer engages the tissue.

4. The method of claim 2, further comprising navigating the catheter configured to retain the device in a delivery configuration by one or more of a trans-septal approach from a right atrium, a trans-apical approach via a left ventricular incision or puncture, or a trans-aortic approach through the aorta.

5. The method of claim 1 further comprising engaging tissue around a circumference of the prosthetic device with a sealing member covering the retainer to inhibit blood flow between the retainer and the tissue.

6. The method of claim 1 wherein the valve support is mechanically isolated from the retainer such that a cross-sectional shape of the valve support remains substantially cylindrical if the retainer is radially deformed into a non-circular shape by engagement with the tissue.

7. A method of treating a mitral valve of a patient, the mitral valve having an annulus and leaflets, the method comprising:

implanting a device within or adjacent to the annulus, the device comprising a valve support and an expandable ring-shaped retainer positioned at an upstream end of the valve support, wherein at least the retainer is disposed between the leaflets, and wherein the retainer is configured to engage and seal with tissue on or near the annulus to prevent migration of the device in an upstream direction;

wherein the upstream end of the valve support is radially inward from and longitudinally overlapping a portion of the retainer when the device is in a deployed configuration; and

wherein the valve support is mechanically isolated from the retainer such that a cross-sectional shape of the valve support remains substantially cylindrical if the retainer is radially deformed into a non-circular shape by engagement with the tissue.

8. The method of claim 7, wherein implanting the device comprises:

positioning the device between the leaflets and downstream of the annulus when the device is in a delivery configuration;

expanding the device from the delivery configuration to an expanded configuration with the retainer extending between the leaflets; and

moving the device in an upstream direction to engage the tissue on or downstream of the annulus with the retainer.

9. The method of claim 7, further comprising radially expanding the valve support after the retainer engages the tissue on or downstream of the annulus.

10. The method of claim 7, further comprising delivering the device by a catheter prior to implantation at the mitral valve.

11. The method of claim 10, further comprising retracting a sheath on the catheter to expose the device in an expanded configuration, and moving the device in an upstream direction such that the retainer engages subannular tissue.

12. The method of claim 7, further comprising navigating a catheter configured to retain the device in a delivery configuration by one or more of a trans-septal approach from a right atrium, a trans-apical approach via a left ventricular incision or puncture, or a trans-aortic approach through an aorta.

13. The method of claim 7, further comprising engaging one or more stabilizing members coupled to the valve support with native tissue.

14. A method of treating a heart valve of a patient, the heart valve having an annulus and leaflets, the method comprising:

positioning a prosthetic heart valve device between the leaflets and downstream of the annulus when the prosthetic heart valve device is in a delivery configuration, the prosthetic heart valve device comprising;

an expandable valve support having an inflow end and an outflow end extending along a longitudinal axis, the expandable valve support having an outer surface and an inner surface, wherein the inner surface is configured to support a prosthetic valve, and wherein the expandable valve support has a cross-sectional shape;

an expandable retainer coupled to and encircling the expandable valve support, the expandable retainer configured to engage and seal with tissue on or near the annulus on an inner or inflow side of the annulus or the leaflets;

wherein the inflow end of the expandable valve support is radially inward from and longitudinally overlapping a portion of the expandable retainer when the prosthetic heart valve device is in a deployed configuration; and

wherein the expandable valve support is mechanically isolated from the expandable retainer such that the cross-sectional shape of the expandable valve support remains substantially cylindrical such that the prosthetic valve remains competent when the expandable retainer is deformed into a non-circular shape by engagement with the tissue;

expanding the prosthetic heart valve device from the delivery configuration to an expanded configuration with the expandable retainer extending between the leaflets; and

moving the prosthetic heart valve device in an upstream direction to engage the tissue on or downstream of the annulus with the expandable retainer.