Prosthetic valve for avoiding obstruction of outflow

• US 10,433,952 B2
• Filed: 01/27/2017
• Issued: 10/08/2019
• Est. Priority Date: 01/29/2016
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Original Assignee: Neovasc Tiara Incorporated (Johnson & Johnson)
• Inventors: Lane, Randy Matthew, Wong, Karen Tsoek-Ji, Kerr, Ian Fraser, Segal, Mark
• Primary Examiner(s): Nguyen, Vi X
• Application Number:
  US15/418,511
• Publication Number:
  US 20170216023A1
• Time in Patent Office: 984 Days
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2230/006 Y-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A prosthetic mitral valve may be anchored in a native mitral valve. The prosthetic mitral valve preferably has a large anterior prosthetic leaflet that spans the entire width of the native anterior leaflet and the anterior prosthetic leaflet moves away from left ventricular outflow tract during systole to create a clear unobstructed outflow path.

Claims

1. A prosthetic heart valve for implantation in a native mitral valve of a patient, said heart valve comprising

a radially expandable anchor frame having an expanded configuration and a collapsed configuration,

wherein the anchor frame further comprises one or more commissure posts, and an anterior anchoring tab, the one or more commissure posts having a free end and an opposite end coupled to the anchor frame,

wherein the anterior anchoring tab is configured to anchor on an anterior portion of the native mitral valve,

wherein the anterior anchoring tab originates from the one or more commissure posts, or wherein the one or more commissure posts originate from the anterior anchoring tab,

wherein the anchor frame further comprises a plurality of wishbone shaped struts originating from the one or more commissure posts, wherein the plurality of wishbone shaped struts are configured to arcuatelv span the distance between adjacent commissure posts, and wherein each wishbone shaped strut is comprised of an anchoring element adjacent a free end of the wishbone shaped strut, the anchoring element configured to engage a delivery catheter;

and

a prosthetic valve coupled to the anchor frame, the prosthetic valve comprising a plurality of prosthetic valve leaflets each having a free end and a fixed end, wherein the fixed end is coupled to the anchor frame, and wherein the free ends of the plurality of prosthetic valve leaflets have an open configuration and a closed configuration, in the open configuration the free ends are disposed away from one another to allow antegrade blood flow therethrough, and in the closed configuration the free ends are disposed adjacent one another to substantially prevent retrograde blood flow therethrough,

wherein the one or more commissure posts are coupled to the plurality of prosthetic valve leaflets, and

wherein the plurality of prosthetic valve leaflets comprise an anterior prosthetic leaflet sized to span the entire width of the native anterior leaflet, and

wherein in systole, the anterior prosthetic leaflet deflects away from the left ventricular outflow tract to provide a clear unobstructed outflow path.

2. The valve of claim 1, wherein the anchor frame comprises a second anterior anchoring tab configured to anchor on a second anterior portion of the native mitral valve.

3. The valve of claim 1, wherein the anchor frame comprises a D-shaped cross-section having a substantially flat anterior portion and a cylindrically shaped posterior portion, wherein the flat anterior portion prevents impingement of the prosthetic heart valve on the left ventricular outflow tract, and the cylindrically shaped posterior portion engages a posterior portion of the native mitral valve.

4. The valve of claim 1, wherein the anterior anchoring tab and the one or more commissure posts are nested in one another when the anchor frame is in the collapsed configuration.

5. The valve of claim 1, wherein the anterior anchoring tab originates from a circumferential position on a circumference of the anchor frame, and wherein the one or more commissure posts also originate from the same circumferential position on the circumference of the anchor frame as the anterior anchoring tab.

6. The valve of claim 1, wherein the anchor frame further comprises a plurality of chordal bumper struts originating from the one or more commissure posts, wherein the plurality of chordal bumper struts are configured to dispose native sub-valvular anatomy away from the LVOT.

7. The valve of claim 1, wherein the commissure posts further comprise an anchoring element adjacent a free end of the commissure post, the anchoring element configured to engage a delivery system.

8. The valve of claim 1, wherein the plurality of wishbone shaped struts are deformable members and allow radial compression of the anchor frame upon retraction into the delivery catheter.

9. The valve of claim 1, wherein the anchoring element comprises a single threaded connector, a buckle connector, or a prong connector.

10. A method of treating a native mitral valve in a patient'"'"'s heart, said method comprising:

providing a prosthetic mitral valve having an anterior prosthetic leaflet that spans a width of a native anterior valve leaflet;

anchoring the prosthetic mitral valve in the native mitral valve,

wherein anchoring the prosthetic mitral valve comprises actuating an actuator mechanism on a delivery system in a first direction, wherein actuating the actuator mechanism in the first direction comprises moving a sheath catheter away from the prosthetic mitral valve to remove a constraint thereby allowing the prosthetic mitral valve to expand, and actuating the actuator mechanism in a second direction opposite the first direction, wherein actuating the actuator mechanism in the second direction comprises moving a sheath catheter toward the prosthetic mitral valve to provide a constraint thereby forcing the prosthetic mitral valve to be compressed, and

wherein actuating the actuator mechanism in the first direction further comprises moving a bell catheter away from an anchoring catheter to remove a constraint thereby allowing a commissure anchor to be released, wherein the commissure anchor comprises an anchoring element that engages a frame of the prosthetic mitral valve to the delivery system, and wherein actuating the actuator mechanism in the second direction comprises moving the bell catheter toward the anchoring catheter to provide a constraint that captures or restrains the commissure anchor and

deflecting the prosthetic anterior leaflet in systole away from the left ventricular outflow tract during systole thereby creating an unobstructed outflow path.

11. The method of claim 10, wherein anchoring comprises anchoring an anterior anchoring tab disposed on an anterior portion of the prosthetic valve to an anterior portion of the native mitral valve.

12. The method of claim 10, comprising spanning a width between two native fibrous trigones, wherein the width is spanned by the anterior prosthetic leaflet.

13. The method of claim 10, comprising radially expanding the prosthetic mitral valve from a collapsed configuration to an expanded configuration, wherein radially expanding the prosthetic mitral valve comprises expanding one or more anterior anchoring tabs away from nested positions within one or more commissure posts.

14. The method of claim 10, comprising radially expanding the prosthetic mitral valve from a collapsed configuration to an expanded configuration, wherein radially expanding the prosthetic mitral valve comprises expanding one or more posterior anchoring tabs away from nested positions within one or more commissure posts.

15. The method of claim 10, wherein actuating the actuator mechanism comprises moving a sheath catheter over the anchoring catheter thereby applying a constraint, wherein applying the constraint comprises allowing a commissure anchor to be compressed, wherein the commissure anchor comprises a flexible anchoring element that engages the frame of the prosthetic mitral valve to the delivery system.