Prosthetic heart valves

Abstract

Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valves are implanted using catheter-based deployment systems that include multiple control wires. In particular implementations, the deployment systems can include a retrieval catheter that can be used to recapture the prosthetic heart valve back into a delivery sheath after being expressed from the delivery sheath. The prosthetic heart valves occupy a small delivery profile, thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved control catheter and / or a deflectable catheter to facilitate deployment of the prosthetic heart valve to a native tricuspid valve site via a superior vena cava or inferior vena cava.

Description

Artificial heart valves can be delivered to the target native heart valve site via one or more delivery catheters. In some embodiments, a catheter-based deployment system including multiple control lines is used to implant the artificial heart valve. In specific embodiments, the deployment system may include a retrieval catheter that can be used to retract the artificial heart valve into the delivery sheath after it has extended from the sheath. The artificial heart valve occupies a small delivery profile, thereby facilitating the advancement of a smaller delivery catheter system to the heart. Some delivery catheter systems may include curved control catheters and / or deflectable catheters to facilitate the deployment of the artificial heart valve to the native tricuspid valve location via the superior or inferior vena cava. Abstract

Claims

Attorney Docket No.: 50855-0006WO1 CLAIMS What is claimed is:

1. A prosthetic valve system comprising: a prosthetic heart valve comprising: a main body including an inflow end portion and an outflow end portion, the main body defining a central axis extending between the inflow and outflow end portions; one or more anterior flaps extending from the outflow end portion in a first direction that is transverse to the central axis; and a posterior flap extending from the outflow end portion in a second direction that is transverse to the central axis; and a valve deployment system comprising: an elongate control catheter defining one or more lumens; a first control wire slidably disposed in the one or more lumens and releasably coupled to the inflow end portion; a second control wire slidably disposed in the one or more lumens and releasably coupled to the outflow end portion; a third control wire slidably disposed in the one or more lumens and releasably coupled to the one or more anterior flaps; and a fourth control wire slidably disposed in the one or more lumens and releasably coupled to the posterior flap.

2. The prosthetic valve system of claim 1, wherein the first control wire comprises a first wire loop that extends out of the one or more lumens and that is releasably coupled to the inflow end portion.

3. The prosthetic valve system of claim 1, wherein the second control wire comprises a second wire loop that extends out of the one or more lumens and that is releasably coupled to the outflow end portion.Attorney Docket No.: 50855-0006WO1 4. The prosthetic valve system of claim 1, wherein the fourth control wire comprises a fourth wire loop that extends out of the one or more lumens and that is releasably coupled to the outflow end portion.

5. The prosthetic valve system of claim 1, wherein the third control wire comprises a single wire segment that extends out of the one or more lumens, releasably couples with the one or more anterior flaps, and terminates in releasable engagement with a distal tip portion of the control catheter.

6. The prosthetic valve system of claim 1, wherein the valve deployment system further comprises a deflectable catheter defining a lumen, and wherein a portion of the control catheter is slidably disposable within the lumen of the deflectable catheter.

7. The prosthetic valve system of claim 6, wherein the valve deployment system further comprises a fifth control wire slidably coupled with the deflectable catheter.

8. The prosthetic valve system of claim 7, wherein the prosthetic heart valve further comprises a posterior arm extending from the inflow end portion of the main body.

9. The prosthetic valve system of claim 8, wherein the fifth control wire comprises a single wire segment that releasably couples with the posterior arm and terminates in releasable engagement with a distal tip portion of the deflectable catheter.

10. The prosthetic valve system of claim 6, wherein a distal end portion of the deflectable catheter is selectively deflectable by manipulating a user control mechanism coupled to a proximal end of the valve deployment system.Attorney Docket No.: 50855-0006WO1 11. A method of deploying a prosthetic heart valve at a native heart valve location, the method comprising: advancing the prosthetic heart valve while the prosthetic heart valve is releasably coupled to an elongate control catheter by: a first control wire slidably disposed in one or more lumens of the control catheter and releasably coupled to an inflow end portion of a main body of the prosthetic heart valve; a second control wire slidably disposed in the one or more lumens and releasably coupled to an outflow end portion of the main body of the prosthetic heart valve; a third control wire slidably disposed in the one or more lumens and releasably coupled to one or more anterior flaps extending transversely from the outflow end portion of the prosthetic heart valve; and a fourth control wire slidably disposed in the one or more lumens and releasably coupled to a posterior flap extending transversely from the outflow end portion of the prosthetic heart valve; and with the prosthetic heart valve at the native heart valve location, releasing: the second control wire from being coupled to the outflow end portion of the main body; the fourth control wire from being coupled to the posterior flap; the first control wire from being coupled to the inflow end portion of the main body; and the third control wire from being coupled to the one or more anterior flaps.

12. The method of claim 11, further comprising adjustably deflecting a distal portion of a deflectable catheter that defines a lumen in which at least a portion of the control catheter is slidably disposed.Attorney Docket No.: 50855-0006WO1 13. The method of claim 12, wherein, during the advancing, the prosthetic heart valve, the control catheter, and the deflectable catheter are positioned within a lumen of a delivery sheath catheter.

14. The method of claim 13, further comprising, prior to the releasing, pulling the delivery sheath catheter proximally to distally express the prosthetic heart valve, a distal end portion of the control catheter, and a distal end portion of the deflectable catheter from the lumen of the delivery sheath catheter.

15. The method of claim 11, wherein the native heart valve location is a tricuspid valve, and wherein the releasing the third control wire from being coupled to the one or more anterior flaps allows the one or more anterior flaps to extend into a right ventricular outflow tract.

16. The method of claim 15, wherein the advancing is via a superior vena cava or an inferior vena cava.

17. A prosthetic heart valve delivery system comprising: a control handle; one or more catheters extending from the control handle, the one or more catheters configured to be releasably attached to the prosthetic heart valve by one or more control wires; a rail system configured to releasably receive the control handle for adjustably mounting the control handle thereon; and a mounting and stabilization system configured to releasably receive the rail system for removably attaching the rail system thereto, wherein the mounting and stabilization system is configured to be removably attached to a procedure table, wherein the rail system includes two rail portions that are movably coupled together by a hinge and thereby adjustable into nonlinear arrangements in relation to each other.Attorney Docket No.: 50855-0006WO1 18. The prosthetic heart valve delivery system of claim 17, wherein the two rail portions include a proximal rail and a distal rail, and wherein a proximal portion of the control handle is adjustably mounted to the proximal rail and a distal portion of the control handle is adjustably mounted to the distal rail.

19. The prosthetic heart valve delivery system of claim 18, wherein the mounting and stabilization system includes a proximal stabilizer and a distal stabilizer, and wherein the proximal rail is removably attachable to the proximal stabilizer and the distal rail is removably attachable to the distal stabilizer.

20. A prosthetic heart valve delivery system comprising: a control handle; one or more catheters extending from the control handle, the one or more catheters configured to be releasably attached to the prosthetic heart valve by one or more control wires; a rail system configured to releasably receive the control handle for adjustably mounting the control handle thereon, the rail system comprising: a first rail portion; a second rail portion; and a removable linking member that can be installed to interconnect the first and second rails portions and that is disconnectable from the first and second rails portions by a clinician-user to totally separate the first and second rails portions from each other; and a mounting and stabilization system configured to releasably receive the rail system for removably attaching the rail system thereto, wherein the mounting and stabilization system is configured to be removably attached to a procedure table,Attorney Docket No.: 50855-0006WO1 wherein the first and second rail portions are adjustable independently of each other and configured to be adjusted into nonlinear orientations in relation to each other.

21. The prosthetic heart valve delivery system of claim 20, wherein the first and second rail portions include a proximal rail and a distal rail, and wherein a proximal portion of the control handle is adjustably mounted to the proximal rail and a distal portion of the control handle is adjustably mounted to the distal rail.

22. The prosthetic heart valve delivery system of claim 21, wherein the mounting and stabilization system includes a proximal stabilizer and a distal stabilizer, and wherein the proximal rail is removably attachable to the proximal stabilizer and the distal rail is removably attachable to the distal stabilizer.

23. A prosthetic valve system comprising: a prosthetic heart valve comprising: a main body including an inflow end portion and an outflow end portion, the main body defining a central axis extending between the inflow and outflow end portions; one or more anterior flaps extending from the outflow end portion in a first direction that is transverse to the central axis; and a posterior flap extending from the outflow end portion in a second direction that is transverse to the central axis; and a valve deployment system comprising: an elongate control catheter defining one or more lumens; a first control wire slidably disposed in the one or more lumens and releasably coupled to the inflow end portion; a second control wire slidably disposed in the one or more lumens and releasably coupled to the outflow end portion; a third control wire slidably disposed in the one or more lumens and releasably coupled to the one or more anterior flaps; andAttorney Docket No.: 50855-0006WO1 a fourth control wire slidably disposed in the one or more lumens and releasably coupled to the posterior flap.

24. The prosthetic valve system of claim 23, wherein the first control wire comprises a first wire loop that extends out of the one or more lumens and that is releasably coupled to the inflow end portion.

25. The prosthetic valve system of claim 23, wherein the second control wire comprises a second wire loop that extends out of the one or more lumens and that is releasably coupled to the outflow end portion.

26. The prosthetic valve system of claim 23, wherein the fourth control wire comprises a fourth wire loop that extends out of the one or more lumens and that is releasably coupled to the outflow end portion.

27. The prosthetic valve system of claim 23, wherein the third control wire comprises a single wire segment that extends out of the one or more lumens, releasably couples with the one or more anterior flaps, and terminates in releasable engagement with a distal tip portion of the control catheter.

28. The prosthetic valve system of claim 23, wherein the valve deployment system further comprises a deflectable catheter defining a lumen, and wherein a portion of the control catheter is slidably disposable within the lumen of the deflectable catheter.

29. The prosthetic valve system of claim 28, wherein the valve deployment system further comprises a fifth control wire slidably coupled with the deflectable catheter.Attorney Docket No.: 50855-0006WO1 30. The prosthetic valve system of claim 29, wherein the prosthetic heart valve further comprises a posterior arm extending from the inflow end portion of the main body.

31. The prosthetic valve system of claim 30, wherein the fifth control wire comprises a single wire segment that releasably couples with the posterior arm and terminates in releasable engagement with a distal tip portion of the deflectable catheter.

32. The prosthetic valve system of claim 29, wherein a distal end portion of the deflectable catheter is selectively deflectable by manipulating a user control mechanism coupled to a proximal end of the valve deployment system.

33. A method of deploying a prosthetic heart valve at a native heart valve location, the method comprising: advancing the prosthetic heart valve while the prosthetic heart valve is releasably coupled to an elongate control catheter by: a first control wire slidably disposed in one or more lumens of the control catheter and releasably coupled to an inflow end portion of a main body of the prosthetic heart valve; a second control wire slidably disposed in the one or more lumens and releasably coupled to an outflow end portion of the main body of the prosthetic heart valve; a third control wire slidably disposed in the one or more lumens and releasably coupled to one or more anterior flaps extending transversely from the outflow end portion of the prosthetic heart valve; and a fourth control wire slidably disposed in the one or more lumens and releasably coupled to a posterior flap extending transversely from the outflow end portion of the prosthetic heart valve; andAttorney Docket No.: 50855-0006WO1 with the prosthetic heart valve at the native heart valve location, releasing: the second control wire from being coupled to the outflow end portion of the main body; the fourth control wire from being coupled to the posterior flap; the first control wire from being coupled to the inflow end portion of the main body; and the third control wire from being coupled to the one or more anterior flaps.

34. The method of claim 33, further comprising adjustably deflecting a distal portion of a deflectable catheter that defines a lumen in which at least a portion of the control catheter is slidably disposed.

35. The method of claim 34, wherein, during the advancing, the prosthetic heart valve, the control catheter, and the deflectable catheter are positioned within a lumen of a delivery sheath catheter.

36. The method of claim 35, further comprising, prior to the releasing, pulling the delivery sheath catheter proximally to distally express the prosthetic heart valve, a distal end portion of the control catheter, and a distal end portion of the deflectable catheter from the lumen of the delivery sheath catheter.

37. The method of claim 33, wherein the native heart valve location is a tricuspid valve, and wherein the releasing the third control wire from being coupled to the one or more anterior flaps allows the one or more anterior flaps to extend into a right ventricular outflow tract.

38. The method of claim 37, wherein the advancing is via a superior vena cava or an inferior vena cava.

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