US20080071363A1
Active / In Force
US
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Valve prosthesis fixation techniques using sandwiching
Assignee: Medtronic Ventor Technologies Ltd
•
Filing: 2007-03-23
•
Granted: —
•
Expires: 2027-03-23
Abstract
Abstract A prosthesis is provided for implantation at a native semilunar valve of a native valve complex. The prosthesis includes a distal fixation member, configured to be positioned in a downstream artery, and shaped so as to define exactly three proximal engagement arms that are configured to be positioned at least partially within respective ones of semilunar sinuses, and, in combination, to apply, to tissue that defines the semilunar sinuses, a first axial force directed toward a ventricle. The prosthesis further includes 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.
Inventors
- 👤 Yosi Tuval
- 👤 Ido Kilemnik
- 👤 Raphael Benary
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 22:10
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2469; A61F2/2409; A61F2/2412; A61F2/2418; A61F2/2427; A61F2/2436; A61F2/95; A61F2/9522; A61F2220/00; A61F2220/0008; A61F2220/0016; A61F2220/0025; A61F2220/005; A61F2220/0058; A61F2220/0075; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0006; A61F2230/0028; A61F2230/005; A61F2230/0054; A61F2230/0063; A61F2230/0071; A61F2230/0073; A61F2230/008; A61F2250/00; A61F2250/0014; A61F2250/0039
Claims Analysis
Total Claims: 64
Claim 1
Independent Claim
181 words
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.
Claim 2
Dependent Claim
181 words
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.
Claim 3
Dependent Claim
68 words
2 . The apparatus according to claim 1 , wherein the native semilunar valve includes a native aortic valve, wherein the downstream artery includes the ascending aorta, wherein the semilunar sinuses include respective aortic sinuses, wherein the distal fixation member is configured to be positioned in the ascending aorta, and wherein the proximal engagement arms are configured to be positioned at least partially within the respective aortic sinuses.
Claim 4
Dependent Claim
3 words
3 . (canceled)
Claim 5
Dependent Claim
3 words
3 . (canceled)
Claim 6
Dependent Claim
48 words
4 . The apparatus according to claim 1 , wherein the distal and proximal fixation members are configured to couple 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.
Claim 7
Dependent Claim
26 words
5 . The apparatus according to claim 1 , wherein the distal fixation member does not press upon the native commissures upon implantation of the prosthesis.
Claim 8
Dependent Claim
30 words
6 . The apparatus according to claim 1 , wherein the prosthesis is configured to apply a radial force of less than 0.5 pounds outwardly against the native semilunar valve.
Claim 9
Dependent Claim
30 words
7 . The apparatus according to claim 1 , wherein the prosthesis is configured to apply the first axial force with a force of at least 40 g during diastole.
Claim 10
Dependent Claim
3 words
8 . (canceled)
Claim 11
Dependent Claim
3 words
8 . (canceled)
Claim 12
Dependent Claim
53 words
9 . The apparatus according to claim 1 , wherein the prosthesis is configured such that any radial force applied by the prosthesis outwardly against the native semilunar valve is insufficient by itself to chronically maintain the prosthesis in position with respect to the native valve complex under conditions of normal cardiac motion.
Claim 13
Dependent Claim
27 words
10 . The apparatus according to claim 1 , wherein the prosthesis is configured, upon implantation thereof, to embrace, without squeezing, leaflets of the native semilunar valve.
Claim 14
Dependent Claim
3 words
11 . (canceled)
Claim 15
Dependent Claim
3 words
11 . (canceled)
Claim 16
Dependent Claim
34 words
12 . The apparatus according to claim 1 , wherein the distal fixation member is configured such that it does not fold over leaflets of the native semilunar valve upon implantation of the prosthesis.
Claim 17
Dependent Claim
3 words
13 . (canceled)
Claim 18
Dependent Claim
3 words
13 . (canceled)
Claim 19
Dependent Claim
42 words
14 . The apparatus according to claim 1 , wherein each of the proximal engagement arms is shaped so as define at least one trough that is configured to be positioned at least partially within a respective one of the semilunar sinuses.
Claim 20
Dependent Claim
109 words
15 . The apparatus according to claim 1 , wherein the three engagement arms meet one another at three respective junctures, wherein the engagement arms are shaped so as define three peak complexes at the three respective junctures, and three trough complexes, each of which is between two of the peak complexes, and wherein, upon implantation of the prosthesis, at least a portion of each of the peak complexes is disposed distal to and in rotational alignment with a respective one of the native commissures of the native semilunar valve, and each of the trough complexes is disposed at least partially within the respective one of the semilunar sinuses.
Claim 21
Dependent Claim
5 words
16 - 21 . (canceled)
Claim 22
Dependent Claim
5 words
16 - 21 . (canceled)
Claim 23
Dependent Claim
49 words
22 . The apparatus according to claim 1 , wherein the prosthesis is configured to apply the first axial force such that a ratio of (a) the first axial force to (b) a radial force applied outwardly by the prosthesis against the native semilunar valve is greater than 1.5:1.
Claim 24
Dependent Claim
5 words
23 - 27 . (canceled)
Claim 25
Dependent Claim
5 words
23 - 27 . (canceled)
Claim 26
Dependent Claim
30 words
28 . The apparatus according to claim 1 , wherein the prosthesis comprises a prosthetic valve configured to assume a closed position during diastole and an open position during systole.
Claim 27
Dependent Claim
5 words
29 - 31 . (canceled)
Claim 28
Dependent Claim
5 words
29 - 31 . (canceled)
Claim 29
Dependent Claim
58 words
32 . The apparatus according to claim 28 , wherein the prosthetic valve comprises one or more prosthetic leaflets, and wherein the prosthetic valve is coupled to the prosthesis such that at least 50% of an axial length of the prosthetic leaflets is distal to native valve leaflets of the native semilunar valve upon implantation of the prosthesis.
Claim 30
Dependent Claim
34 words
33 . The apparatus according to claim 1 , wherein the distal fixation member is configured to apply the first axial force to one or more semilunar sinus floors of the native valve complex.
Claim 31
Dependent Claim
5 words
34 - 41 . (canceled)
Claim 32
Dependent Claim
5 words
34 - 41 . (canceled)
Claim 33
Dependent Claim
39 words
42 . The apparatus according to claim 1 , wherein the proximal fixation member comprises an inner support structure, and wherein the distal fixation member comprises an outer support structure that is placed partially over the inner support structure.
Claim 34
Dependent Claim
38 words
43 . The apparatus according to claim 42 , wherein the outer support structure is shaped so as to define exactly three distal diverging strut supports, from which respective ones of the proximal engagement arms extend radially outward.
Claim 35
Dependent Claim
5 words
44 - 45 . (canceled)
Claim 36
Dependent Claim
5 words
44 - 45 . (canceled)
Claim 37
Dependent Claim
62 words
46 . The apparatus according to claim 43 , wherein the prosthesis is configured such that, upon implantation at the native valve complex, the engagement arms are aligned by rotation with respective ones of the semilunar sinuses, and wherein the prosthesis is configured such that the engagement arms self-align themselves by rotation during implantation of the prosthesis at the native valve complex.
Claim 38
Dependent Claim
3 words
47 . (canceled)
Claim 39
Dependent Claim
3 words
47 . (canceled)
Claim 40
Dependent Claim
37 words
48 . The apparatus according to claim 42 , wherein the inner support structure is shaped so as to define a bulging proximal skirt, a proximal portion of which is configured to apply the second axial force.
Claim 41
Dependent Claim
5 words
49 - 108 . (canceled)
Claim 42
Dependent Claim
5 words
49 - 108 . (canceled)
Claim 43
Dependent Claim
183 words
109 . Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, 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 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.
Claim 44
Dependent Claim
183 words
109 . Apparatus comprising a prosthesis for implantation at a native semilunar valve of a native valve complex of a subject, 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 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.
Claim 45
Dependent Claim
5 words
110 - 112 . (canceled)
Claim 46
Dependent Claim
5 words
110 - 112 . (canceled)
Claim 47
Dependent Claim
40 words
113 . The apparatus according to claim 109 , wherein the distal fixation member comprises one or more engagement arms that are positioned at least partially within respective semilunar sinuses of the native valve complex, upon implantation of the prosthesis.
Claim 48
Dependent Claim
31 words
114 . The apparatus according to claim 113 , wherein the engagement arms are configured to apply respective forces to respective floors of the semilunar sinuses, upon implantation of the prosthesis.
Claim 49
Dependent Claim
5 words
115 - 149 . (canceled)
Claim 50
Dependent Claim
5 words
115 - 149 . (canceled)
Claim 51
Dependent Claim
187 words
150 . A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising: 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; and positioning 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.
Claim 52
Dependent Claim
187 words
150 . A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising: 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; and positioning 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.
Claim 53
Dependent Claim
44 words
151 . The method according to claim 150 , wherein the native semilunar valve includes a native aortic valve, wherein the downstream artery includes the ascending aorta, and wherein positioning the distal fixation member comprises positioning the distal fixation member in the ascending aorta.
Claim 54
Dependent Claim
5 words
152 - 155 . (canceled)
Claim 55
Dependent Claim
5 words
152 - 155 . (canceled)
Claim 56
Dependent Claim
86 words
156 . The method according to claim 150 , wherein positioning the distal and proximal fixation members comprises positioning the engagement arms at least partially within the respective ones of the semilunar sinuses before positioning the proximal fixation member at least partially on the ventricular side of the native valve complex, such that the engagement arms prevent leaflets of the native valve complex from opening more than a predetermined desired amount, the opening being because of force applied by the proximal fixation member to the leaflets.
Claim 57
Dependent Claim
156 words
157 . A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising: 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; and positioning 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.
Claim 58
Dependent Claim
156 words
157 . A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising: 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; and positioning 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.
Claim 59
Dependent Claim
5 words
158 - 175 . (canceled)
Claim 60
Dependent Claim
5 words
158 - 175 . (canceled)
Claim 61
Dependent Claim
193 words
176 . A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising: 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.
Claim 62
Dependent Claim
193 words
176 . A method for implanting a valve prosthesis at a native semilunar valve of a native valve complex of a subject, the method comprising: 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.
Claim 63
Dependent Claim
5 words
177 - 188 . (canceled)
Claim 64
Dependent Claim
5 words
177 - 188 . (canceled)
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