TECHNIQUES FOR PERCUTANEOUS MITRAL VALVE REPLACEMENT AND SEALING

• US 20130172992A1
• Filed: 07/21/2011
• Published: 07/04/2013
• Est. Priority Date: 07/21/2010
• Status: Active Grant

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: Gross, Yossi, Miller, Eran, Zipory, Yuval, Reich, Tal, Hacohen, Gil
• Granted Patent: US 9,017,399 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts

Abstract

Apparatus and methods are described including a prosthetic valve support (40) configured to be placed at a patient'"'"'s native atrioventricular valve annulus. The valve support defines an annular element (44) that defines an inner cross-sectional area thereof. An expandable prosthetic valve (80) is placed into the patient'"'"'s ventricle, the prosthetic valve including an expandable frame (79) and prosthetic valve leaflets (82) coupled to the frame. When the frame is in a non-constrained state thereof, a cross-sectional area of the frame, along at least a given portion L of the frame'"'"'s length, is greater than the cross-sectional area defined by the annular element. The prosthetic valve is couplable to the prosthetic valve support at any location along the portion, by the frame being expanded when the location along the portion is aligned with the annular element. Other applications are also described.

Claims

1-63. -63. (canceled)

64. Apparatus for use with a native valve of a heart of a subject, the native valve having an annulus and being disposed between an atrium of the heart and a ventricle of the heart, the apparatus comprising:

a sheath, configured to be transluminally advanced to the atrium of the heart;

a plurality of tubular longitudinal members, configured to be advanced through the sheath;

a plurality of tissue anchors, configured to be advanced through the sheath and into the ventricle and there to be anchored to heart tissue, each of the tissue anchors being reversibly couplable to a respective tubular longitudinal member;

a prosthetic valve support comprising an annular element;

shaped to define a plurality of holes that are configured to receive a respective tubular longitudinal member, such that the upstream support portion is slidable over the plurality of tubular longitudinal members,

configured to be transluminally advanced toward the native valve in a subsequent act of advancement, separately from the advancing of the tissue anchors, and

configured to be coupled to an atrial surface of the annulus by being coupled to the tissue anchors while the tissue anchors are anchored in the ventricle; and

a prosthetic valve configured to be transluminally advanced to the native valve, and to be intracorporeally coupled to the annular element by at least part of the prosthetic valve being expanded while disposed within an opening defined by the annular element.

65. The apparatus according to claim 64, wherein the annular element is configured to be transluminally advanced toward the native valve through the sheath.

66. The apparatus according to claim 64, wherein the prosthetic valve is configured to be transluminally advanced toward the native valve through the sheath.

67. The apparatus according to claim 64, wherein the prosthetic valve is configured to be transluminally advanced to the native valve independently of the annular element.

68. The apparatus according to claim 64, wherein the annular element is configured to be coupled to the atrial surface of the annulus without the use of cardiopulmonary bypass, and wherein the prosthetic valve is configured to be coupled to the annular element without the use of cardiopulmonary bypass.

69. The apparatus according to claim 64, wherein the annular element is configured to be coupled to the atrial surface of the native valve while the native valve continues to function.

70. The apparatus according to claim 64, wherein the annular element, the at least one tissue anchor, and the prosthetic valve are configured to be transfemorally advanced toward the native valve.

71. The apparatus according to claim 64, wherein the tissue anchors are configured to facilitate advancement of the annular element toward the atrial surface of the annulus.

72. The apparatus according to claim 64, wherein the anchors are configured to be anchored to the heart tissue suturelessly.

73. The apparatus according to claim 64, wherein the prosthetic valve comprises an expandable frame having a length, and is configured to be coupled to the annular element at a location anywhere along a portion of the length.

74. The apparatus according to claim 64, wherein the annular portion is configured to constrain the expansion of the prosthetic valve.

75. The apparatus according to claim 64, wherein the annular element is configured to be coupled to the tissue anchors via commissural gaps between native leaflets of the native valve of the heart.

76. The apparatus according to claim 75, wherein the annular element is configured to be coupled to the atrial surface of the native valve while the native leaflets continue to function.

77. A method for use with a native valve of a heart of the subject, the native valve having an annulus and being disposed between an atrium of the heart and a ventricle of the heart, the method comprising:

through a sheath, transluminally advancing at least one tissue anchor into the ventricle of the heart, and there anchoring the tissue anchor to heart tissue;

in a subsequent act of advancement, separately from the advancing of the at least one tissue anchor, transluminally advancing an annular element of a prosthetic valve support toward the atrium of the subject;

subsequently, coupling the annular element to an atrial surface of the annulus by coupling the annular element to the at least one tissue anchor;

transluminally advancing a prosthetic valve toward the native valve of the subject; and

intracorporeally coupling the prosthetic valve to the annular element by placing at least part of the prosthetic valve within an opening defined by the annular element, and expanding the prosthetic valve.

78. The method according to claim 77, wherein anchoring the tissue anchor to the tissue comprises suturelessly anchoring the tissue anchor to the tissue.

79. The method according to claim 77, wherein coupling the annular element to the atrial surface of the native valve comprises coupling the annular element to the atrial surface of the native valve while the native valve continues to function.

80. The method according to claim 77, wherein expanding the prosthetic valve comprises expanding the prosthetic valve until the expansion of the prosthetic valve is constrained by the prosthetic valve support.

81. The method according to claim 77, wherein transluminally advancing the prosthetic valve comprises transluminally advancing the prosthetic valve through the sheath subsequently to advancing the annular element.

82. The method according to claim 77, wherein anchoring the at least one tissue anchor, coupling the annular element to the atrial surface, and coupling the prosthetic valve to the annular element, comprise anchoring the at least one tissue anchor, coupling the annular element to the atrial surface, and coupling the prosthetic valve to the annular element, without the use of cardiopulmonary bypass.

83. The method according to claim 77, wherein coupling the annular element to an atrial surface of the annulus comprises coupling an annular element that is shaped to define an opening having a cross-sectional area that is less than 90% of an area defined by the annulus.

84. The method according to claim 77, wherein transluminally advancing the annular element comprises transluminally advancing the annular element through the sheath.

85. The method according to claim 77, further comprising transfemorally advancing the sheath toward a transatrial septum of the subject, wherein:

transluminally advancing the annular element comprises transfemorally advancing the annular element,

transluminally advancing the at least one tissue anchor comprises transfemorally advancing the at least one tissue anchor, and

transluminally advancing the prosthetic valve comprises transfemorally advancing the prosthetic valve.

86. The method according to claim 77, further comprising advancing the annular element toward the atrial surface of the annulus, at least in part facilitated by the at least one tissue anchor.

87. The method according to claim 77, wherein anchoring the tissue anchor to the tissue comprises anchoring the tissue anchor to leaflet tissue of the native valve.

88. The method according to claim 77, wherein coupling the annular element to the atrial surface comprises coupling the annular element to a tubular longitudinal member that is coupled to the tissue anchor.

89. The method according to claim 77, wherein advancing the at least one tissue anchor comprises advancing at least one tissue anchor that is reversibly coupled to a respective tubular longitudinal member, and the method further comprises, before coupling the annular element to the at least one tissue anchor, sliding the annular element over the tubular longitudinal member.

90. The method according to claim 89, wherein the method further comprises pulling the tubular longitudinal member proximally before coupling the annular element to the at least one tissue anchor.

91. The method according to claim 89, wherein sliding the annular element over the tubular longitudinal member comprises sliding the annular element over the tubular longitudinal member after anchoring the tissue anchor to the heart tissue.

92. The method according to claim 77, wherein coupling the annular element to the at least one tissue anchor comprises coupling the annular element to the at least one tissue anchor via commissural gaps between native leaflets of the valve of the heart.

93. The method according to claim 92, wherein coupling the annular element to the atrial surface of the native valve comprises coupling the annular element to the atrial surface of the native valve while the native leaflets continue to function.

94. The method according to claim 77, wherein:

the prosthetic valve includes an expandable frame having a length,

the method further comprises selecting a location along a portion of the length of the frame at which to couple the prosthetic valve to the annular portion, and

intracorporeally coupling the prosthetic valve to the annular element comprises intracorporeally coupling the prosthetic valve to the annular element at the location.

95. The method according to claim 94, wherein expanding the prosthetic valve comprises expanding the prosthetic valve such that a portion of the prosthetic valve at the location applies radial force to the annular element.