VENTRICULARLY-ANCHORED PROSTHETIC VALVES
First Claim
1. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:
- a valve body;
comprising (1) a first frame shaped to define a lumen therethrough, and (2) a valve member disposed within the lumen,having a compressed state in which the first frame has a first diameter, andhaving an expanded state in which the first frame has a second diameter that is greater than the first diameter;
an upstream support;
configured to be placed against an upstream surface of the native valve,comprising a second frame,having a compressed state, andhaving an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter; and
a flexible sheet that couples the upstream support to the valve body.
2 Assignments
0 Petitions
Accused Products
Abstract
Apparatus is provided, including: (A) a valve body (204) including a first frame (206) shaped to define a lumen therethrough, and a valve member (205) disposed within the lumen, (B) an upstream support (210), configured to be placed against an upstream surface of a native heart valve, and (C) a flexible sheet (214) that couples the upstream support to the valve body. The valve body has a compressed state in which the first frame has a first diameter, and an expanded state in which the first frame has a second diameter that is greater than the first diameter. The support includes a second frame (212) that has a compressed state, and an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter. Other embodiments are also described.
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Citations
165 Claims
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1. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:
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a valve body; comprising (1) a first frame shaped to define a lumen therethrough, and (2) a valve member disposed within the lumen, having a compressed state in which the first frame has a first diameter, and having an expanded state in which the first frame has a second diameter that is greater than the first diameter; an upstream support; configured to be placed against an upstream surface of the native valve, comprising a second frame, having a compressed state, and having an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter; and a flexible sheet that couples the upstream support to the valve body. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48)
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49. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:
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a prosthetic valve, configured to be percutaneously delivered to the native valve; an annular upstream support, configured to be placed against an upstream surface of the native valve, and to support the prosthetic valve at the native valve; a tissue anchor, comprising a tissue-engaging element configured to be anchored to ventricular muscle tissue of the heart; a tether, coupled to the tissue anchor; and a spring, couplable to the tether so as to elastically couple the tissue-engaging element to the prosthetic valve. - View Dependent Claims (50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72)
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73. Apparatus for use with a native heart valve of a subject, the apparatus comprising:
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a valve body; having an upstream end, a downstream end, and a longitudinal axis therebetween, comprising a lateral wall that circumscribes the longitudinal axis and defines a longitudinal lumen, and comprising a valve member disposed within the lumen; an upstream support having an inner perimeter couplable to the valve body at a first longitudinal position of the valve body, the upstream support being configured to extend radially outward from the valve body and the inner perimeter; and a flexible sheet defining a first aperture, a second aperture and a lateral wall therebetween, a first portion of the sheet that defines the first aperture being circumferentially attached to the upstream support portion at a radius that is greater than a radius of the inner perimeter, and a second portion of the sheet that defines the second aperture being circumferentially attached to the valve body at a second longitudinal position of the valve body, such that a pocket region is defined between the sheet and at least the first longitudinal position. - View Dependent Claims (74, 75, 76, 77, 78, 79, 80)
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81. Apparatus for use with a native heart valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising:
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an annular upstream support defining an opening therethrough, and configured to be placed against an upstream surface of the native heart valve; a tubular valve body having an upstream end, a downstream end and a lumen therebetween, the lumen having a first diameter, and the valve body being separated from the upstream element by a gap between the upstream end of the valve body and the upstream element; one or more tissue-engaging elements that protrude radially outward from the valve body so as to define a second diameter that is greater than the first diameter; and a flexible sheet shaped to define a conduit, a downstream portion of the sheet being coupled to the valve body, an upstream portion of the sheet being coupled to the upstream element, and the sheet spanning the gap. - View Dependent Claims (82, 83)
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84. Apparatus for use with a native heart valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising:
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an annular upstream element defining an opening therethrough, and configured to be placed against an upstream surface of the native heart valve; a flexible sheet, shaped to define a conduit, and coupled to the upstream element such that the conduit is in fluid communication with the opening; and a valve body, coupled to the flexible sheet such that the conduit provides fluid communication between the prosthetic valve and the upstream element. - View Dependent Claims (85, 86)
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87. Apparatus, for use with a guide member that extends into a subject, the apparatus comprising:
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a delivery tool, comprising a housing, the housing; being transluminally advanceable into the subject, shaped to define an orifice at an end of the housing, and having a lateral wall shaped to define a slit that is continuous with the orifice; an implant; configured to be housed by the housing, and comprising an eyelet that (1) is slidable over the guide member, and (2) when the implant is housed by the housing, extends through the slit and radially beyond the lateral wall such that the eyelet facilitates transluminal sliding of the implant and the housing along the guide member and into the subject, the apparatus being configured such that, while (1) the implant remains within the subject, and (2) the guide member remains disposed through the eyelet, (1) the implant is removable from the housing via the orifice, and (2) the housing is removable from the subject. - View Dependent Claims (88, 89)
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90. A method for use with a native valve of a heart of a subject, the method comprising:
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transluminally anchoring a tissue anchor to ventricular tissue of a subject using an anchor-manipulation tool, the tissue anchor being coupled to a first portion of a tether; transluminally delivering an annular upstream support and a prosthetic valve to the heart, the prosthetic valve including (1) a valve body shaped to define a lumen therethrough, and (2) one or more tissue-engaging legs configured to protrude laterally outward from the valve body; pressing the tissue-engaging legs in an upstream direction against a ventricular surface of the native valve by applying a force to the prosthetic valve while measuring the force; applying, to the tether, a tension that changes a shape of a spring coupled to the tether, while observing the shape of the spring using imaging; and at least in part responsively to the observed shape of the spring, facilitating holding of the upstream support against an upstream surface of the native valve by locking a second portion of the tether to at least one component selected from the group consisting of;
the prosthetic valve and the upstream support. - View Dependent Claims (91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103)
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104. A method, comprising:
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transluminally advancing a plurality of tissue anchors, coupled to a respective plurality of springs, into a body of a subject; anchoring the plurality of tissue anchors to tissue of the subject; tensioning at least one of the springs; using imaging, while the tension is applied to the at least one spring, observing a state of the at least one spring; and at least in part responsively to the observed state of at least one spring, adjusting a tension on at least one of the springs.
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105. A method, for use with a native valve of a heart of a subject, the method comprising:
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applying a first tension to a tether that couples (a) a tissue anchor anchored to ventricular tissue of a subject, to (b) a prosthetic valve body, the tether having a length between the tissue anchor and the valve body; by applying an atrially-directed force to the prosthetic valve body, pressing, against tissue of the native valve, a tissue-engaging element that protrudes radially from the valve body transluminally advancing a prosthetic valve body to a native valve of the subject; while applying the atrially-directed force, measuring; a pressing force of the tissue-engaging element against the tissue of the native valve, and a second tension on the tether, the second tension differing from the first tension at least in part due to the atrially-directed force; and at least in part responsively to the measured pressing force and the measured second tension, performing an action selected from the group consisting of;
adjusting the length of the tether between the tissue anchor and the valve body, and locking the valve body to the tether.
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106. A method for use with a native valve of a heart of a subject, the method comprising:
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transluminally delivering a tissue anchor to a ventricle of the heart, and anchoring the tissue anchor to ventricular muscle tissue of the subject; transluminally delivering an upstream support to an atrium of the heart, and placing the upstream support against an upstream surface of an annulus of the native valve; and changing a shape of the upstream support by tensioning a tether coupled to upstream support and to the tissue anchor; and extracorporeally fluoroscopically observing the shape change of the upstream support. - View Dependent Claims (107, 108, 109)
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110. Apparatus for use with a valve of a heart of a subject, the apparatus comprising:
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a transluminally-deliverable tissue anchor; a tether, a first end thereof coupled to the tissue anchor; and a delivery tool, comprising; a steerable catheter having a longitudinal axis, and being transluminally deliverable to the valve, and an obstructing element; disposed at a longitudinal site of the catheter, configured to extend laterally outward from the catheter, and dimensioned, when extending laterally outward from the catheter, to inhibit movement of at least the longitudinal site through the valve by abutting tissue of the valve, and an anchor manipulator; reversibly couplable to the tissue anchor, slidable through the catheter, and configured to drive the anchor into ventricular tissue of the heart of the subject. - View Dependent Claims (111, 112, 113, 114, 115)
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116. A method, comprising:
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transluminally anchoring a tissue anchor to tissue of a subject using an anchor-manipulation tool; subsequently applying to the anchor a pulling force having a given magnitude; using imaging, observing a movement of the tissue anchor in response to the pulling force; and at least in part responsively to the observed movement, performing an action selected from the group consisting of;
de-anchoring the tissue anchor from the tissue, and decoupling the anchor-manipulation tool from the tissue anchor.
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117. Apparatus, for implantation at a native valve of a heart of a subject, the native valve being disposed between an atrium and a ventricle of the heart, the apparatus comprising:
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a tubular valve body; having an upstream portion, configured to be disposed in the atrium of the heart of the subject, having a downstream portion, configured to be disposed in the ventricle of the subject, having an elastic portion, disposed between the upstream portion and the downstream portion, and elastically coupling the upstream portion to the downstream portion, and shaped to define a continuous lumen through the upstream portion, the elastic portion, and the downstream portion; and at least one valve member, disposed in the lumen of the valve body, and configured to facilitate flow of blood of the subject from the upstream portion of the valve body to the downstream portion of the valve body, and to inhibit flow of the blood from the downstream portion of the valve body to the upstream portion of the valve body. - View Dependent Claims (118, 119, 120, 121, 122, 123, 124)
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125. Apparatus for use with a native valve of a heart of a subject, the native valve having a plurality of leaflets that meet at a plurality of commissures, the apparatus comprising:
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at least one tissue anchor, configured to be anchored to a first site within a ventricle of the heart of the subject; at least one longitudinal member, coupled at a distal end thereof to a respective one of the at least one tissue anchors; an upstream support, comprising an upstream support portion configured to be slidable over the longitudinal member and placed against an upstream surface of the native valve; and at least one locking member, configured to be slidable over a respective one of the at least one longitudinal members, and to be lockable to the respective longitudinal member such that a portion of the respective longitudinal member that is disposed between the respective anchor and the upstream support portion is longer than 1 cm. - View Dependent Claims (126, 127)
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128. A method for use with a native valve of a heart of a subject, the native valve having a plurality of leaflets that meet at a first commissure and at a second commissure, the method comprising:
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anchoring a first tissue anchor to a first site within a ventricle of the heart of the subject, the first tissue anchor being coupled to a distal end of a first longitudinal member; anchoring a second tissue anchor to a second site within the ventricle of the heart of the subject, the second tissue anchor being coupled to a distal end of a second longitudinal member; subsequently, placing at least an upstream support portion of a prosthetic valve support against an upstream surface of the native valve, the valve being disposed between the ventricle and an atrium of the heart of the subject; and securing the upstream support portion against the upstream surface of the valve by; coupling the upstream support portion to the first longitudinal member such that at least part of a portion of the first longitudinal member that is disposed between the upstream support portion and the first tissue anchor, is disposed between the first and second leaflets at the first commissure, and coupling the upstream support portion to the second longitudinal member such that at least part of a portion of the second longitudinal member that is disposed between the upstream support portion and the first tissue anchor, is disposed between the first and second leaflets at the second commissure. - View Dependent Claims (129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147)
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148. Apparatus for use with a body of a subject, the apparatus comprising:
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at least a first implantable member; a first longitudinal member, coupled at a distal end thereof to the first implantable member; a second longitudinal member, at least a portion of the second longitudinal member being reversibly couplable to the first longitudinal member; and a tubular member; slidable over the first and second longitudinal members, shaped to define a lumen therethrough, and configured, when the portion of the second longitudinal member is (1) coupled to the first longitudinal member, and (2) disposed within the lumen of the tubular member, to inhibit decoupling of the portion of the second longitudinal member from the first longitudinal member. - View Dependent Claims (149, 150, 151, 152, 153, 154, 155, 156, 157, 158)
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159. Apparatus for use at a native valve of a heart of a subject, the apparatus comprising:
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a tissue anchor, configured to be transluminally, transcatheterally advanced to a ventricle of the heart of the subject, and to be coupled to tissue of the ventricle; a longitudinal member, coupled at a distal end thereof to the tissue anchor; a wire, a portion of the wire being reversibly couplable to the longitudinal member; a tubular member; slidable over the longitudinal member and the wire, shaped to define a lumen therethrough, and configured, when the portion of the wire is (1) coupled to the longitudinal member, and (2) disposed within the lumen of the tubular member, to inhibit decoupling of the portion of the wire from the longitudinal member; a prosthetic valve support comprising an upstream support portion slidable over the tubular member, and to be placed against an upstream surface of an annulus of the native valve by sliding over the tubular member; and a locking member, slidable over the tubular element and lockable to the longitudinal member. - View Dependent Claims (160, 161, 162, 163, 164, 165)
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Specification