PROSTHETIC HEART VALVE DEVICES AND ASSOCIATED SYSTEMS AND METHODS

• US 20150327994A1
• Filed: 07/23/2015
• Published: 11/19/2015
• Est. Priority Date: 06/21/2011
• Status: Active Grant

• Current Assignee: Twelve, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, Hanson III
• Granted Patent: US 9,579,196 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• 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 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 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0015 Kidney-shaped, e.g. bean-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0069 Sealing means

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 an expandable support having an outer surface and configured for placement between leaflets of the native valve. The device can also include a plurality of asymmetrically arranged arms coupled to the expandable support and configured to receive the leaflets of the native valve between the arms and the outer surface. In some embodiments, the arms can include tip portions for engaging a subannular surface of the native valve.

Claims

1-30. -30. (canceled)

31. A prosthetic treatment apparatus for treating a native mitral valve having a native annulus and native leaflets, the prosthetic treatment apparatus comprising:

a support having a downstream portion configured to be positioned toward a left ventricle and an upstream portion configured to be positioned toward a left atrium, wherein the support is expandable from a low-profile configuration for delivery to an expanded configuration for implantation at the native mitral valve;

a prosthetic valve mounted to the support and adapted to allow blood flow in a downstream direction and to block blood flow in an upstream direction;

a plurality of arms coupled to the downstream portion of the support, wherein the arms extend outwardly from the support in an upstream direction when the support is in the expanded configuration; and

a skirt having an upstream end coupled to the support and a downstream end, wherein—

at least a portion of the skirt downstream of the upstream end extends radially outwardly from the valve support,

the skirt extends around an entire circumference of the support, and

the skirt is configured to engage the native leaflets and fill gaps between the support and native tissue to inhibit blood flow therethrough.

32. The prosthetic treatment apparatus of claim 31 wherein the skirt is attached to the support to limit radial expansion of the skirt.

33. The prosthetic treatment apparatus of claim 31 wherein the support has a mid-portion between the upstream portion and the downstream portion, and wherein the upstream end of the skirt is attached to the mid-portion of the support.

34. The prosthetic treatment apparatus of claim 31 wherein the downstream end of the skirt is disposed between the arms and the support when the support is in the expanded configuration.

35. The prosthetic treatment apparatus of claim 31 wherein the arms are biased outwardly in the expanded configuration.

36. The prosthetic treatment apparatus of claim 31 wherein the arms are configured to move relative to the support to compress native tissue as the support expands.

37. The prosthetic treatment apparatus of claim 31 wherein the skirt is configured to be inflated with blood to urge the skirt against the native tissue at or below the native annulus.

38. The prosthetic treatment apparatus of claim 31 wherein the arms are configured to engage native tissue downstream of the native annulus.

39. The prosthetic treatment apparatus of claim 31, further comprising a retention structure coupled to the upstream portion of the support configured to engage tissue on an upstream side of the native annulus, wherein the retention structure comprises a plurality of fingers extending radially outward from the support.

40. The prosthetic treatment apparatus of claim 31, further comprising a retention structure coupled to the upstream portion of the support, wherein, in the expanded configuration, the retention structure is axially spaced apart from the arms so as to compress the native annulus between the retention structure and the arms.

41. The prosthetic treatment apparatus of claim 31, further comprising a cover and/or a coating disposed on at least a portion of the arms, wherein the cover and/or coating is configured to distribute forces applied by the arms on native tissue.

42. The prosthetic treatment apparatus of claim 31 wherein the upstream end has a first diameter and the downstream end has a second diameter greater than the first diameter, and wherein the downstream end is spaced apart from the support.

43. A prosthetic treatment apparatus for treating a native mitral valve having a native annulus and native leaflets, the prosthetic treatment apparatus comprising:

a support having a distal portion configured to be positioned toward a left ventricle and a proximal portion configured to be positioned toward a left atrium, wherein the support is expandable from a low-profile configuration for implantation to an expanded configuration at a native mitral valve;

a prosthetic valve mounted to the support and adapted to allow blood flow from the proximal portion of the support to the distal portion of the support and to block blood flow travelling proximally from the left ventricle to the left atrium;

a plurality of anchoring arms connected to the distal portion of the support, wherein the arms extend proximally and radially outwardly from the support when the support is in the expanded configuration; and

a sealing member extending around a circumference of the support and having a first end coupled to the support and a second end, wherein the sealing member has a portion between the first and second ends that extends radially outwardly from the support when the support is in the expanded configuration, and wherein the sealing member is configured to be inflated by blood disposed between the sealing member and the support to urge the sealing member against native tissue at or below the annulus.

44. The prosthetic treatment apparatus of claim 43 wherein the anchoring arms are configured to engage native tissue on or downstream of the native annulus, and wherein at least one of the anchoring arms includes a covering and/or a coating to distribute force applied to the native tissue.

45. The prosthetic treatment apparatus of claim 43 wherein the anchoring arms are configured to engage inward facing surfaces of the native leaflets when the prosthetic treatment apparatus is implanted at the native mitral valve.

46. The prosthetic treatment apparatus of claim 43, further comprising a retention structure coupled to the proximal portion of the support configured to engage tissue on an upstream side of the native annulus, wherein the retention structure is axially spaced apart from the anchoring arms when the support is in the expanded configuration so as to compress the native annulus between the retention structure and the anchoring arms.

47. A method of treating a mitral valve having a native annulus and leaflets, the method comprising:

positioning a prosthetic valve device between or adjacent the native annulus, wherein the prosthetic valve device includes a support and a prosthetic valve mounted to the support; and

expanding the support such that (a) a downstream portion of the support is positioned toward a left ventricle, (b) an upstream portion of the support is positioned toward a left atrium, and (c) a plurality of arms coupled to the downstream portion of the support extend outwardly from the support in an upstream direction to engage native tissue on or downstream of the native annulus,

wherein, following expansion, blood flow urges a skirt of the prosthetic valve device against the native leaflets and thereby fills gaps between the support and the native tissue to inhibit blood flow therethrough, wherein the skirt has an upstream end attached to the support and a downstream portion spaced apart from the support, and wherein the skirt extends around a circumference of the support.

48. The method of claim 47 wherein the skirt inflates with blood as the blood flow urges the skirt against the native leaflets such that the downstream portion of the skirt expands outwardly against the native tissue.

49. The method of claim 47, further comprising delivering the prosthetic valve device to the mitral valve using a transapical approach via a puncture or incision in the left ventricle.

50. The method of claim 47, further comprising delivering the prosthetic valve device to the mitral valve using a trans-septal approach from the right atrium.

51. The method of claim 47 wherein, after expansion of the support, the arms engage native tissue on an inward facing surface of the native leaflets.

52. The method of claim 47, further comprising:

engaging native tissue on an upstream side of the native annulus with a retention member coupled to the upstream portion of the support; and

compressing the native annulus between the arms and the retention member.

53. The method of claim 47 wherein the arms move relative to the support as the support is expanded, and wherein the method further comprises compressing the native tissue with the arms as the arms move relative to the support.

54. A prosthetic device configured for transcatheter replacement of a native mitral valve, the prosthetic device comprising:

a support having a downstream portion configured to be positioned toward a left ventricle and an upstream portion configured to be positioned toward a left atrium, wherein the support is expandable from a low-profile configuration for delivery to an expanded configuration for implantation at a the native mitral valve;

a prosthetic valve mounted to the support and adapted to allow blood flow in a downstream direction and to block blood flow in an upstream direction;

a plurality of anchoring arms coupled to the downstream portion of the support, wherein the anchoring arms extend outwardly from the support in an upstream direction to engage a subannular surface of the native mitral valve when the support is in the expanded configuration; and

a sealing member extending around a perimeter of the support, the sealing member having first portion mounted to the support between the upstream and downstream portions, and a second portion downstream of the first portion and extending radially outwardly from the support, wherein—

the sealing member is configured to engage the annulus, leaflets, and/or commissures of the native mitral valve to minimize perivalvular leaks.

55. The prosthetic device of claim 54 wherein the anchoring arms comprise distal tips configured to atraumatically engage the annulus of the native mitral valve.

56. The prosthetic device of claim 54 wherein the anchoring arms are configured to push against leaflets and/or chordae of the native mitral valve.

57. The prosthetic device of claim 54 wherein the anchoring arms are distributed circumferentially along the support to distribute the load across the subannular surface of the native mitral valve.

58. The prosthetic device of claim 54 wherein the anchoring arms comprise curved elbow portions, and wherein the curved elbow portions of the anchoring arms comprise arcuate portions that extend from a downstream end of the downstream portion of the support.

59. The prosthetic device of claim 58 wherein the arcuate portions extend radially inward relative to an outer surface of the support.

60. The prosthetic device of claim 65 wherein the support comprises a frame having a plurality of struts.