PROSTHETIC VALVE FOR AVOIDING OBSTRUCTION OF OUTFLOW

• US 20170216023A1
• Filed: 01/27/2017
• Published: 08/03/2017
• Est. Priority Date: 01/29/2016
• Status: Active Grant

• Current Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Original Assignee: Neovasc Tiara Incorporated (Neovasc Incorporated)
• Inventors: Wong, Karen Tsoek-Ji, Kerr, Ian Fraser, Segal, Mark, Lane, Randy Matthew
• Granted Patent: US 10,433,952 B2
• Time in Patent Office: 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; 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, 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 an anterior anchoring tab configured to anchor on an anterior portion of the native mitral valve.

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

5. 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.

6. The valve of claim 1, wherein the anchor frame 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, the one or more commissure posts coupled to the plurality of prosthetic valve leaflets, and

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

7. The valve of claim 6, 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.

8. The valve of claim 6, 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.

9. The valve of claim 6, 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.

10. The valve of claim 9, 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.

11. The valve of claim 9, 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.

12. The valve of claim 9, 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 arcuately 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.

13. The valve of claim 12, wherein the plurality of wishbone shaped struts are deformable members and allow radial compression of the anchor frame upon retraction into the delivery catheter.

14. The valve of claim 12, wherein the anchoring element comprises a single threaded connector, a buckle connector, or a prong connector.

3. (canceled)

15. 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 and an upstream end and a downstream end, the radially expandable anchor frame comprising one or more commissure posts having a free end and an opposite end coupled to the anchor frame adjacent the downstream end, and an anterior anchoring tab coupled to the anchor frame adjacent the downstream end, wherein the anterior anchoring tab is configured to anchor on an anterior portion of the native mitral valve, and 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; and

a prosthetic valve coupled to the anchor frame, the prosthetic valve comprising one or more 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 one or more commissure posts are coupled to the one or more prosthetic valve leaflets.

16. The valve of claim 15, wherein the free ends of the one or more prosthetic valve leaflets have an open configuration and a closed configuration, wherein 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 prosthetic valve leaflets comprise an anterior prosthetic leaflet sized to span a width of a native anterior valve leaflet between two native fibrous trigones, and wherein in systole, the anterior prosthetic leaflet deflects away from the left ventricular outflow tract to provide a clear unobstructed outflow path.

18. The valve of claim 15, wherein the anchor frame comprises a second anterior anchoring tab configured to anchor on a second anterior portion of the native mitral valve.

19. The valve of claim 15, 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 portion engages the posterior portion of the native mitral valve.

20. The valve of claim 15, 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.

21. The valve of claim 15, 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.

17. (canceled)

22. 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; and

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

23. The method of claim 22, 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.

24. The method of claim 22, comprising spanning a width between two native fibrous trigones, wherein the width is spanned by the anterior prosthetic leaflet.

25. The method of claim 22, 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.

26. The method of claim 22, 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.

27. The method of claim 22, 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.

28. The method of claim 27, 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.

29. The method of claim 28, wherein providing the constraint comprises releasably sliding a retaining element over the commissure anchor.

30. The method of claim 27, 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.

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

providing a prosthetic mitral valve coupled to a radially expandable anchor frame having an upstream end and a downstream end, the radially expandable anchor frame comprising one or more commissure posts having a free end and an opposite end coupled to the anchor frame adjacent the downstream end, and an anterior anchoring tab coupled to the anchor frame adjacent the downstream end,

expanding the radially expandable anchor frame from a collapsed configuration to an expanded configuration,

anchoring the prosthetic mitral valve in the native mitral valve, wherein the anterior anchoring tab anchors on an anterior portion of the native mitral valve, and

radially expanding the anterior anchoring tab away from a nested position within the one or more commissure posts.

33. The method of claim 31, wherein radially expanding the anchor frame comprises expanding the one or more commissure posts away from a nested position within the anterior anchoring tab.

34. The method of claim 31, wherein the prosthetic mitral valve comprises an anterior prosthetic leaflet, the method comprising:

spanning a width of a native anterior valve leaflet between two native fibrous trigones, deflecting the anterior prosthetic leaflet away from a left ventricular outflow tract, and creating an unobstructed outflow path by the deflection of the anterior prosthetic leaflet.

32. (canceled)

35. A delivery system for delivering a prosthesis to a target treatment area, said system comprising:

an inner guidewire catheter having a proximal end, a distal end, and a lumen extending therebetween, the lumen sized to slidably receive a guidewire;

a flexible dilating tip coupled to the guidewire catheter, the dilating tip having a tapered and flexible self-dilating edge,

a sheath catheter slidably disposed over the inner guidewire catheter, the sheath catheter having a proximal end and a distal end;

an actuator mechanism operably coupled to the proximal end of the sheath catheter, wherein actuation of the actuator mechanism in a first direction moves the sheath catheter away from the dilator tip thereby removing a constraint from the prosthesis and allowing the prosthesis to expand, and

wherein actuation of the actuator mechanism in a second direction opposite the first direction moves the sheath catheter into engagement with the dilator tip thereby enclosing the prosthesis therein.

36. The system of claim 35, further comprising a stationary anchoring catheter fixedly disposed over the guidewire catheter, the anchoring catheter having an anchor element adjacent a distal end of the anchor catheter and configured to engage the prosthesis.

37. The system of claim 36, further comprising a bell catheter slidably disposed over the anchoring catheter, the bell catheter having a bell element disposed adjacent a distal end of the bell catheter, wherein the bell element constrains the prosthesis into engagement with the anchor catheter.

38. The system of claim 36, wherein the anchoring catheter has a flexible prong type anchor element adjacent the distal end of the anchor catheter, configured to engage the prosthesis.

39. The system of claim 38, wherein the sheath catheter is slidably disposed over the anchoring catheter, wherein an advancement of the distal end of the sheath catheter collapses the flexible prong type anchor elements into engagement with the prosthesis.

40. The system of claim 36, further comprising a stationary bell catheter fixedly disposed over the anchoring catheter, the bell catheter having a bell element disposed adjacent a distal end of the bell catheter, wherein the bell element disengages the prosthesis from the anchor catheter.

41. The system of claim 35, further comprising a bell catheter rotatably disposed over the guidewire catheter, the bell catheter having an internally threaded bell element disposed adjacent a distal end of the bell catheter, wherein the threaded bell element constrains the prosthesis into engagement.

42. The system of claim 41, further comprising a second actuator mechanism operably coupled to a proximal end of the bell catheter, wherein actuation of the second actuator mechanism in a first direction couples the prosthesis to the bell catheter, providing a constraint for the prosthesis, and wherein actuation of the second actuator mechanism in a second direction opposite the first direction de-couples the prosthesis from the bell catheter, removing the constraint from the prosthesis.

43. The system of claim 35, further comprising a rotating torque catheter rotatably disposed over the guidewire catheter, the torque catheter having a driving gear element adjacent a distal end of the torque catheter and configured to transmit torque.

44. The system of claim 43, further comprising a plurality of rotating thread-connector catheters rotatably disposed adjacent the torque catheter, the thread-connector catheters each having a driven gear element adjacent a distal end of each thread connector catheter, and a threaded socket adjacent to the distal end of each thread connector catheter, the driven gear elements sized to enmesh with the driving gear element and receive torque, and the threaded sockets configured to constrain the prosthesis into engagement.

45. The system of claim 44, further comprising a second actuator mechanism operably coupled to a proximal end of the torque catheter, wherein actuation of the second actuator mechanism in a first direction couples the prosthesis to the thread-connector catheters, and wherein actuation of the second actuator mechanism in a second direction opposite the first direction de-couples the prosthesis from the thread-connector catheters.