PROSTHETIC HEART VALVE DEVICES, PROSTHETIC MITRAL VALVES AND ASSOCIATED SYSTEMS AND METHODS

• US 20150142100A1
• Filed: 10/19/2012
• Published: 05/21/2015
• Est. Priority Date: 10/19/2011
• Status: Active Grant

• Current Assignee: Foundry Newco XII, Inc. (Medtronic Plc)
• Original Assignee: Twelve, Inc. (Medtronic Plc)
• Inventors: Morriss, John, Gifford, Hanson III, Fann, James I., Dueri, Jean-Pierre, McLean, Matt, Gittings, Darin, Luna, Michael, Deem, Mark, Sutton, Douglas, Grainger, Jeffry J.
• Granted Patent: US 10,016,271 B2
• Time in Patent Office: Days
• US Class Current: 623/2.4
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• 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 2220/0041 using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0066 stapled
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve (100) includes a flexible anchoring member (110) at least partially surrounding and coupled to an inner valve support (120). The device can further include a prosthetic valve (130) coupled to, mounted within, or otherwise carried by the valve support. The valve support includes a plurality of posts (122) connected circumferentially by a plurality of struts (124), where the posts extend along an axial direction generally parallel to the longitudinal axis (101) and the struts extend circumferentially around and transverse to the longitudinal axis. The posts extend an entire longitudinal height HI of the valve support 120. The device also includes one or more sealing members (140) and tissue engaging elements (170) like spikes.

Claims

1-6. -6. (canceled)

7. A prosthetic heart valve device for implantation at a native mitral valve, the native mitral valve having an annulus and leaflets, comprising:

an anchoring member positionable in a location between the leaflets, the anchoring member having a first portion and a second portion, wherein the first portion of the anchoring member is expandable to a deployed configuration having a dimension larger than a corresponding dimension of the annulus such that upstream movement of the anchoring member is blocked by engagement of the first portion of the anchoring member with tissue on or near the annulus on an inward-facing side of the leaflets, wherein the first portion of the anchoring member comprises an upstream portion and the second portion of the anchoring member comprises a downstream portion; and

a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, the valve support having an expanded configuration in which the prosthetic valve is competent, wherein when the valve support is in the expanded configuration and the anchoring member is in the deployed configuration an upstream region of the valve support is spaced radially inward from the first portion of the anchoring member such that if the anchoring member is deformed inwardly the upstream region of the valve support remains substantially undeformed.

8. The device of claim 7 wherein the first portion of the anchoring member is configured to engage valve tissue selected from an inward-facing surface of the annulus and an inward facing surface of the leaflets under the annulus.

35. The device of claim 7 wherein the valve support extends around a longitudinal axis, and wherein the first portion of the anchoring member flares outward from the longitudinal axis by a taper angle.

36. The device of claim 35 wherein the taper angle continuously changes between the first portion and the second portion.

37. The device of claim 35 wherein the taper angle varies around a circumference of the first portion.

38. The device of claim 35 wherein the taper angle is between approximately 30°

to about 750°

.

39. The device of claim 35 wherein the taper angle is between approximately 40°

to about 60°

.

43. The device of claim 7 wherein the first portion of the anchoring member includes a flared portion and a vertical portion, the vertical portion is configured to radially expand and engage the annulus.

44. The device of claim 43 wherein the flared portion includes tissue engaging elements configured to engage subannular tissue.

45. The device of claim 7 wherein the first portion is radially separated from the valve support by a gap.

49. The device of claim 7, further comprising a skirt overlying a surface of the anchoring member, the skirt configured to inhibit blood flow between the anchoring member and the valve support.

50. The device of claim 7, further comprising a sealing member coupled to the anchoring member configured to inhibit blood flow between the anchoring member and the tissue.

54. The device of claim 7, further comprising a valve coupled to the valve support to inhibit retrograde blood flow.

55. The device of claim 54 wherein the valve is a tri-leaflet valve.

66. The device of claim 7 wherein the first portion of the anchoring member has a first flexibility and the valve support has a second flexibility less than the first flexibility such that a region of the valve support remains substantially undistorted when the first portion of the anchoring member distorts to the native mitral valve.

67. The device of claim 7 wherein:

the anchoring member is defined by a structure separate from the valve support;

the valve support is coupled to the anchoring member at the second portion of the anchoring member; and

the second portion of the anchoring member is longitudinally spaced apart from the first portion of the anchoring member.

80. The device of claim 7 wherein the anchoring member resists upstream migration of the device without any element of the device extending behind the leaflets of the native mitral valve.

101. The device of claim 7, further comprising a plurality of tissue engaging elements configured to engage tissue of the annulus or leaflets.

102. The device of claim 101 wherein the tissue engaging elements have:

a piercing configuration in which the tissue engaging elements have a low profile for penetrating the tissue; and

a retaining configuration in which the tissue engaging elements have an expanded profile for maintaining the tissue engaging element within the tissue.

125. The device of claim 7, further comprising a second anchoring structure coupled to the first portion of the anchoring member and extending outwardly so as to engage tissue on or near the annulus.

127. The device of claim 7 wherein:

the valve support comprises an inner frame having an outer surface and an inner surface, the inner surface configured to support a prosthetic valve; and

the anchoring member comprises an outer frame coupled to the inner frame, the outer frame having an first portion with a cross-sectional dimension greater than a corresponding cross-sectional dimension of an annulus of the mitral valve, wherein the first portion is configured to engage tissue at or below the annulus of the mitral valve and prevent migration of the device in an upward direction during ventricular systole, and wherein at least the first portion of the frame is mechanically isolated from the inner frame.

9-34. -34. (canceled)

40-42. -42. (canceled)

46-48. -48. (canceled)

51-53. -53. (canceled)

56-65. -65. (canceled)

68-79. -79. (canceled)

81-100. -100. (canceled)

103-124. -124. (canceled)

126. (canceled)

128-138. -138. (canceled)

139. A method for replacement of a native heart valve having an annulus and leaflets coupled to the annulus, the method comprising:

positioning a prosthetic device including an anchoring member and a valve support coupled to the anchoring member at a native mitral valve of the patient wherein;

a first portion of the anchoring member engages tissue on or downstream of an annulus of the native mitral valve between the leaflets so as to inhibit movement of the prosthetic device in an upstream direction, wherein the first portion of the anchoring member deforms to conform to a shape of the native mitral valve;

the valve support expands to an expanded configuration in which an upstream portion of the valve support is radially spaced apart from the first portion of the anchoring member; and

a portion of the valve support maintains a predetermined cross-sectional shape upon expansion suitable for supporting a prosthetic valve in a configuration in which the prosthetic valve is competent while the first portion of the anchoring member deforms with respect to the shape of the native mitral valve.

141. The method of claim 139, further comprising delivering the device by catheter prior to positioning the prosthetic device between the leaflets.

142. The method of claim 141, 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 upstream portion of the anchoring member engages tissue.

143. The method of claim 141, 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.

144. The method of claim 139, wherein:

positioning the device includes locating 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 anchoring member extending between the leaflets; and

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

145. The method of claim 144 wherein an upstream portion of the anchoring member has an oval shape when in a deployed configuration and the tissue at or below the annulus has a corresponding oval shape, and wherein the method further comprises:

viewing the anchoring member and the mitral valve with echocardiography or fluoroscopy; and

aligning the upstream portion of the anchoring member to engage with the tissue on or downstream of the annulus based on the echocardiography or fluoroscopy.

146. The method of claim 139 wherein a valve is coupled to the valve support, the valve configured to allow blood to flow from a left atrium to a left ventricle and to inhibit blood flow from the left ventricle to the left atrium.

147. The method of claim 139 wherein the anchoring member inhibits movement of the device toward the left atrium by engaging subannular tissue when the left ventricle contracts and the valve inhibits blood flow from the left ventricle to the left atrium.

148. The method of claim 139, further comprising concurrently delivering the anchoring member and the valve support coupled to the anchoring member by catheter prior to implantation at the mitral valve.

149. The method of claim 139, 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 upstream portion of the anchoring member engages subannular tissue.

150. The method of claim 139, 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 the aorta.

151. The method of claim 139, further comprising activating a temporary valve coupled to the valve support after the device is implanted.

152. The method of claim 151, further comprising positioning a replacement valve in an interior of the valve support and expanding the replacement valve into engagement with the valve support.

153. The method of claim 139, further comprising coupling a valve to the valve support after the device has been implanted at the mitral valve.

154. The method of claim 139, further comprising radially expanding the valve support after the anchoring member engages the tissue on or downstream of the annulus.

155. The method of claim 139 wherein positioning the device includes implanting the anchoring member and the valve support within or adjacent to the annulus by moving the device through a plurality of configurations including:

a first configuration in which the valve support and the anchoring member are radially contracted, and wherein the valve support has a first cross-sectional shape;

a second configuration in which the valve support and the anchoring member are radially expanded and the valve support has a second cross-sectional shape greater than the first cross-sectional shape; and

a third configuration in which the anchoring member is engaged with and at least partially deformed by tissue on or downstream of the annulus while the valve support remains in the second cross-sectional shape.

156. The method of claim 139, further comprising engaging one or more stabilizing members coupled to the anchoring member with native tissue.

140. (canceled)

157-162. -162. (canceled)

163. A device for repair or replacement of a native valve of a heart, the native valve having an annulus and leaflets coupled to the annulus, comprising:

an anchoring member including a first portion and a second portion, wherein the first portion is configured to engage tissue on or under the annulus so as to inhibit movement of the device in an upstream direction and to deform into a non-circular shape to at least partially conform to the shape of the native valve; and

a valve support coupled to the second portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has a cross-sectional shape, wherein the anchoring member extends upwardly and flares outwardly apart from the valve support from a downstream portion of the valve support;

wherein when the anchoring member and valve support are in a fully expanded configuration the first portion of the anchoring member is mechanically isolated from the valve support such that the cross-sectional shape of the valve support remains sufficiently stable that the prosthetic valve remains competent when the anchoring member is deformed in the non-circular shape.

164. A prosthetic heart valve device for repair or replacement of a native heart valve of a patient, the heart valve having a native annulus and leaflets, comprising:

an anchoring member having an upstream portion having a first cross-sectional dimension and a downstream portion having a second cross-sectional dimension less than the first cross-sectional dimension, wherein the upstream portion is configured to engage cardiac tissue at the native annulus to restrain the anchoring member from movement in an upstream direction;

a valve support coupled to the downstream portion of the anchoring member and configured to support a prosthetic valve, wherein the valve support has an upstream region and a downstream region, and wherein, with the anchoring member and valve support in a fully expanded configuration, the upstream region of the valve support is radially spaced apart from the upstream portion of the anchoring member such that the upstream portion of the anchoring member can deform inwardly without substantially deforming the upstream region of the valve support.

165. A device for repair or replacement of a native valve having an annulus and a plurality of leaflets, the device comprising:

an expandable valve support configured for placement between the leaflets, the support having a first region, a second region, and an interior in which a valve may be coupled; and

an anchoring member having a first portion and a second portion, wherein the second portion of the anchoring member is coupled to the second region of the valve support, and wherein the first portion of the anchoring member extends outwardly away from the second region of the expandable valve support, the first portion of the anchoring member having a first perimeter configured to engage tissue between the leaflets on or near the annulus to inhibit movement of the device in an upstream direction;

wherein with the support and the anchoring member in a fully expanded configuration the anchoring member is mechanically isolated from the valve support such that a force exerted radially at or near the first perimeter will not substantially alter a shape of the valve support.