VALVE PROSTHESIS CONFIGURED FOR DEPLOYMENT IN ANNULAR SPACER

• US 20190015093A1
• Filed: 07/20/2018
• Published: 01/17/2019
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: HACOHEN, Gil, GROSS, Yossi, REICH, Tal
• Granted Patent: US 10,531,872 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0464 for soft tissue
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0041 J-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

Abstract

Embodiments of the present disclosure are directed to prosthetic heart valves and methods of use thereof. In one implementation, a prosthetic heart valve may include an annular spacer having a spacer opening therein and a disc-shaped wall configured to obstruct blood flow. The annular spacer may be configured for engaging with a native heart valve opening, such as the orifice of a mitral valve. The spacer opening may be sized to be smaller than the native heart valve opening. The prosthetic heart valve may also include a central valve section configured for disposal within the spacer opening. The central valve section may be separate from the annular spacer and may include one or more prosthetic valve leaflets.

Claims

1-63. -63. (canceled)

64. A prosthetic heart valve, comprising:

an annular spacer having a spacer opening therein and a disc-shaped wall configured to obstruct blood flow, wherein the annular spacer is configured for engaging with a native heart valve opening and wherein the spacer opening is sized to be smaller than the native heart valve opening; and

a central valve section configured for disposal within the spacer opening, wherein the central valve section is separable from the annular spacer.

65. The prosthetic heart valve of claim 64, wherein the annular spacer is configured for engaging with a heart valve annulus and wherein the spacer opening is sized to be smaller than the heart valve annulus.

66. The prosthetic heart valve of claim 64, wherein an outer diameter of the central valve section is smaller than a diameter of a heart valve annulus.

67. The prosthetic heart valve of claim 64, wherein the central valve section is configured for implantation after implantation of the annular spacer.

68. The prosthetic heart valve of claim 64, wherein the annular spacer is configured to provide coupling between the central valve section and a heart valve annulus.

69. The prosthetic heart valve of claim 64, wherein the disc-shaped wall includes a support stent having a plurality of struts.

70. The prosthetic heart valve of claim 64, wherein the disc-shaped wall is configured to extend around a heart valve annulus and to extend at least partially into an atrium of the heart.

71. The prosthetic heart valve of claim 64, wherein the disc-shaped wall is configured to engage at least one tissue anchor.

72. The prosthetic heart valve of claim 71, wherein the at least one tissue anchor includes a plurality of leaves configured to splay outward upon anchor implantation.

73. The prosthetic heart valve of claim 71, wherein the at least one tissue anchor is configured to engage ventricular tissue of a native mitral valve.

74. The prosthetic heart valve of claim 71, wherein the at least one tissue anchor is configured to be secured to the disc-shaped wall via a male-female locking arrangement.

75. The prosthetic heart valve of claim 64, wherein the disc-shaped wall includes at least one hole therein, the at least one hole configured to slide along a delivery mechanism.

76. The prosthetic heart valve of claim 64, wherein the annular spacer includes a cylindrical skirt configured to extend at least partially into a ventricle of the heart, wherein the spacer opening extends through the cylindrical skirt.

77. The prosthetic heart valve of claim 76, wherein an outer diameter of the cylindrical skirt is smaller than an outer diameter of the disc-shaped wall.

78. The prosthetic heart valve of claim 76, wherein the cylindrical skirt includes a support stent having a plurality of struts.

79. The prosthetic heart valve of claim 76, wherein the cylindrical skirt is configured to be invertible.

80. The prosthetic heart valve of claim 79, wherein the cylindrical skirt is configured to extend at least partially into an atrium of the heart and to be inverted and pushed at least partially into the ventricle by the central valve section.

81. The prosthetic heart valve of claim 79, configured to enable native leaflets of the heart to remain functional until the central valve section is implanted and the cylindrical skirt is inverted.

82. The prosthetic heart valve of claim 79, configured such that native leaflets of the heart are not obstructed by the prosthetic heart valve until the central valve section is implanted and the cylindrical skirt is inverted.

83. The prosthetic heart valve of claim 64, wherein the central valve section includes a flexible wire frame having a plurality of struts.

84. The prosthetic heart valve of claim 64, wherein the central valve section includes at least one anchoring protrusion configured to extend radially outward beyond at least a portion of the annular spacer.

85. The prosthetic heart valve of claim 84, wherein the at least one anchoring protrusion is configured to engage native leaflets of the heart and to compress the native leaflets of the heart against the annular spacer.