Methods for Implanting a Valve Prothesis
First Claim
1. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having semilunar sinuses and native commissures, the prosthesis comprising:
- a distal fixation member, configured to be positioned in a downstream artery of the subject selected from the group consisting of;
an ascending aorta, and a pulmonary trunk, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of the semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle of the subject; and
a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex.
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Abstract
A method for implanting a valve prosthesis at a native cardiac valve complex of a subject comprises implanting a distal fixation member of the valve prosthesis downstream of a native valve of the native valve complex such that two or more engagement arms of the distal fixation member apply, to a downstream side of the native valve, a first axial force directed upstream. The method also comprises implanting a proximal fixation member of the valve prosthesis at least partially upstream of the native valve, such that the proximal fixation member applies, to an upstream side of the native valve, a second axial force directed downstream, such that application of the first and second forces couples the valve prosthesis to the native valve complex. The engagement arms and the proximal fixation member capture leaflets of the native valve therebetween without folding over leaflets of the native valve.
105 Citations
188 Claims
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1. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the native valve complex having semilunar sinuses and native commissures, the prosthesis comprising:
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a distal fixation member, configured to be positioned in a downstream artery of the subject selected from the group consisting of;
an ascending aorta, and a pulmonary trunk, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of the semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle of the subject; anda proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex. - 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, 49, 50, 51, 52, 53)
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54. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the prosthesis comprising:
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a distal fixation member, configured to be positioned in a downstream artery of the subject selected from the group consisting of;
an ascending aorta, and a pulmonary trunk, and to apply, to tissue that defines one or more semilunar sinuses of the native valve complex, a first axial force directed toward a ventricle of the subject; anda proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native semilunar valve, and to apply, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex. - View Dependent Claims (55, 56, 57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, 70, 71, 72, 73, 74, 75, 76, 77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108)
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109. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the prosthesis comprising:
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a distal fixation member, configured to be positioned in a downstream artery of the subject selected from the group consisting of an ascending aorta, and a pulmonary trunk, and to apply, to native commissures of the native semilunar valve, a first axial force directed toward a ventricle of the subject, without applying any force to native leaflets of the native semilunar valve, and wherein the distal fixation member is configured to rotationally align with the native semilunar valve; and a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof, upon implantation of the prosthesis. - View Dependent Claims (110, 111, 112, 113, 114, 115)
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116. Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, the prosthesis comprising:
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a distal fixation member, configured to be positioned in a downstream artery of the subject selected from the group consisting of an ascending aorta, and a pulmonary trunk, and to apply a first axial force directed toward a ventricle of the subject; and a proximal fixation member coupled to the distal fixation member, the proximal fixation member configured to be positioned at least partially on a ventricular side of the native valve complex, and to apply a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof, wherein the prosthesis is configured to apply a radial force of less than 0.5 pounds outwardly against the native semilunar valve. - View Dependent Claims (117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139, 140, 141, 142, 143, 144, 145, 146, 147, 148, 149)
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150. A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising:
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providing a distal fixation member of the valve prosthesis coupled to a proximal fixation member of the valve prosthesis, which distal fixation member is shaped so as to define exactly three proximal engagement arms; positioning the distal fixation member in a downstream artery of the subject selected from the group consisting of;
an ascending aorta, and a pulmonary trunk, such that the three proximal engagement arms are positioned at least partially within respective semilunar sinuses of the native valve complex, and, in combination, apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle of the subject; andpositioning the proximal fixation member at least partially on a ventricular side of the native semilunar valve, such that the proximal fixation member applies, to the ventricular side of the native valve complex, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex. - View Dependent Claims (151, 152, 153, 154, 155, 156)
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157. A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising:
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providing a distal fixation member of the valve prosthesis coupled to a proximal fixation member of the valve prosthesis; positioning the distal fixation member in a downstream artery of the subject selected from the group consisting of;
an ascending aorta, and a pulmonary trunk, such that the distal fixation member applies, to a downstream side of the native valve complex, a first axial force directed toward a ventricle of the subject; andpositioning the proximal fixation member at least partially on a ventricular side of the native semilunar valve, such that the proximal fixation member applies, to a ventricular side of the native semilunar valve, a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native semilunar valve. - View Dependent Claims (158, 159, 160, 161, 162, 163, 164, 165, 166, 167, 168, 169, 170, 171, 172, 173, 174, 175)
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176. A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising:
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providing a distal fixation member of the valve prosthesis coupled to a proximal fixation member of the valve prosthesis; positioning the distal fixation member in a downstream artery of the subject selected from the group consisting of;
an ascending aorta, and a pulmonary trunk, such that the distal fixation member applies, to native commissures of the native semilunar valve, a first axial force directed toward a ventricle of the subject, without applying any force to native leaflets of the native semilunar valve;causing the distal fixation member to rotationally align with the native semilunar valve by gently rotating the valve prosthesis; and positioning the proximal fixation member at least partially on a ventricular side of the native valve complex, such that the proximal fixation member applies a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof. - View Dependent Claims (177, 178, 179, 180, 181, 182)
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183. A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising:
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providing a distal fixation member of the valve prosthesis coupled to a proximal fixation member of the valve prosthesis; positioning the distal fixation member in a downstream artery of the subject selected from the group consisting of an ascending aorta, and a pulmonary trunk, such that the distal fixation member applies a first axial force directed toward a ventricle of the subject; and positioning the proximal fixation member at least partially on a ventricular side of the native valve complex, such that the proximal fixation member applies a second axial force directed toward the downstream artery, such that application of the first and second forces couples the prosthesis to the native valve complex by axially sandwiching the native valve complex from a downstream side and the ventricular side thereof, and the prosthesis applies a radial force of less than 0.5 pounds outwardly against the native semilunar valve. - View Dependent Claims (184, 185, 186, 187, 188)
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Specification