US20060036317A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Decives and methods for heart valve treatment
Assignee: Edwards Lifesciences LLC
•
Filing: 2005-07-07
•
Granted: —
•
Expires: 2025-07-07
Abstract
Abstract Devices and methods for improving the function of a valve (e.g., mitral valve) by positioning a spacing filling device outside and adjacent the heart wall such that the device applies an inward force against the heart wall acting on the valve. A substantially equal and opposite force may be provided by securing the device to the heart wall, and/or a substantially equal and opposite outward force may be applied against anatomical structure outside the heart wall. The inward force is sufficient to change the function of the valve, and may increase coaptation of the leaflets, for example. The space filling device may be implanted by a surgical approach, a transthoracic approach, or a transluminal approach, for example. The space filling portion may be delivered utilizing a delivery catheter navigated via the selected approach, and the space filling portion may be expandable between a smaller delivery configuration and a larger deployed configuration.
Inventors
- 👤 Robert Vidlund
- 👤 Cyril Schweich
- 👤 Todd Mortier
- 👤 Richard Schroeder
- 👤 Craig Ekvall
- 👤 Jason Kalgreen
- 👤 Edward Matthees
- 👤 David Kusz
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 00:46
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2478; A61F2/2481; A61B; A61B17/00; A61B17/00234; A61B17/04; A61B17/12; A61B17/132; A61B17/1322; A61B17/1325; A61B17/32; A61B17/3205; A61B17/32053; A61B2017/00238; A61B2017/00243; A61B17/0401; A61B2017/0404; A61B2017/0412; A61B2017/0464; A61B2017/0496; A61B17/30; A61B2017/306; A61B2017/308; A61F2/2442; Y; Y10; Y10S; Y10S623/00; Y10S623/902; Y10S623/904
Claims Analysis
Total Claims: 87
Claim 1
Independent Claim
60 words
1 . A method for improving heart valve function, the method comprising: providing a device comprising at least one expandable protrusion; and positioning the expandable protrusion in contact with an external surface of the heart wall such that the protrusion exerts an inward force against the heart wall proximate a valve, wherein the force is sufficient to alter valve function.
Claim 2
Dependent Claim
60 words
1 . A method for improving heart valve function, the method comprising: providing a device comprising at least one expandable protrusion; and positioning the expandable protrusion in contact with an external surface of the heart wall such that the protrusion exerts an inward force against the heart wall proximate a valve, wherein the force is sufficient to alter valve function.
Claim 3
Dependent Claim
37 words
2 . The method of claim 1 , further comprising positioning the device such that the device exerts a force substantially opposite to the inward force as a result of securing the device to the heart wall.
Claim 4
Dependent Claim
34 words
3 . The method of claim 1 , further comprising positioning the device such that the device exerts a force substantially opposite to the inward force on anatomical structure external to the heart wall.
Claim 5
Dependent Claim
21 words
4 . The method of claim 1 , wherein the inward force is sufficient to draw leaflets of the valve together.
Claim 6
Dependent Claim
41 words
5 . The method of claim 4 , wherein the valve leaflets define a line of coaptation and positioning the expandable protrusion includes positioning the expandable protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.
Claim 7
Dependent Claim
15 words
6 . The method of claim 1 , wherein the valve is a mitral valve.
Claim 8
Dependent Claim
21 words
7 . The method of claim 1 , further comprising adjusting a position of the device while observing the valve function.
Claim 9
Dependent Claim
20 words
8 . The method of claim 1 , wherein the inward force is exerted on an annulus of the valve.
Claim 10
Dependent Claim
21 words
9 . The method of claim 1 , wherein the inward force is sufficient to reposition papillary muscles of the valve.
Claim 11
Dependent Claim
19 words
10 . The method of claim 1 , further comprising positioning the device outside the epicardium of the heart.
Claim 12
Dependent Claim
22 words
11 . The method of claim 10 , further comprising positioning the device between the epicardium and the pericardium of the heart.
Claim 13
Dependent Claim
16 words
12 . The method of claim 11 , further comprising attaching the device to the epicardium.
Claim 14
Dependent Claim
17 words
13 . The method of claim 12 , further comprising maintaining the device free of the pericardium.
Claim 15
Dependent Claim
20 words
14 . The method of claim 1 , further comprising delivering the device to the heart via a surgical approach.
Claim 16
Dependent Claim
20 words
15 . The method of claim 1 , further comprising delivering the device to the heart via a subthoracic approach.
Claim 17
Dependent Claim
16 words
16 . The method of claim 15 , wherein the subthoracic approach includes a subxiphoid approach.
Claim 18
Dependent Claim
16 words
17 . The method of claim 15 , wherein the subthoracic approach includes a posterior approach.
Claim 19
Dependent Claim
17 words
18 . The method of claim 1 , further comprising delivering the device via a transluminal approach.
Claim 20
Dependent Claim
30 words
19 . The method of claim 18 , wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.
Claim 21
Dependent Claim
38 words
20 . The method of claim 18 , wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.
Claim 22
Dependent Claim
30 words
21 . The method of claim 18 , wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.
Claim 23
Dependent Claim
17 words
22 . The method of claim 18 , wherein the transluminal approach is via the azygos vein.
Claim 24
Dependent Claim
16 words
23 . The method of claim 18 , wherein the transluminal approach is via the esophagus.
Claim 25
Dependent Claim
24 words
24 . The method of claim 2 , wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.
Claim 26
Dependent Claim
24 words
25 . The method of claim 3 , wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.
Claim 27
Dependent Claim
18 words
26 . The method of claim 1 , wherein the inward force is exerted throughout the cardiac cycle.
Claim 28
Dependent Claim
80 words
27 . A method for improving heart valve function, the method comprising: providing a device having at least one protrusion; and positioning the device relative to the heart such that the at least one protrusion is in contact with an external surface of a heart wall and exerts an inward force against the heart wall proximate the valve and such that the device exerts a force substantially opposite to the inward force against an anatomical structure outside the heart wall.
Claim 29
Dependent Claim
80 words
27 . A method for improving heart valve function, the method comprising: providing a device having at least one protrusion; and positioning the device relative to the heart such that the at least one protrusion is in contact with an external surface of a heart wall and exerts an inward force against the heart wall proximate the valve and such that the device exerts a force substantially opposite to the inward force against an anatomical structure outside the heart wall.
Claim 30
Dependent Claim
23 words
28 . The method of claim 27 , wherein the at least one protrusion exerts an inward force sufficient to alter valve function.
Claim 31
Dependent Claim
21 words
29 . The method of claim 27 , wherein the inward force is sufficient to draw leaflets of the valve together.
Claim 32
Dependent Claim
39 words
30 . The method of claim 29 , wherein the valve leaflets define a line of coaptation and positioning the protrusion includes positioning the protrusion such that the inward force is exerted substantially orthogonal to the line of coaptation.
Claim 33
Dependent Claim
15 words
31 . The method of claim 27 , wherein the valve is a mitral valve.
Claim 34
Dependent Claim
21 words
32 . The method of claim 27 , further comprising adjusting a position of the device while observing the valve function.
Claim 35
Dependent Claim
20 words
33 . The method of claim 27 , wherein the inward force is exerted on an annulus of the valve.
Claim 36
Dependent Claim
21 words
34 . The method of claim 27 , wherein the inward force is sufficient to reposition papillary muscles of the valve.
Claim 37
Dependent Claim
19 words
35 . The method of claim 27 , further comprising positioning the device outside the epicardium of the heart.
Claim 38
Dependent Claim
22 words
36 . The method of claim 35 , further comprising positioning the device between the epicardium and the pericardium of the heart.
Claim 39
Dependent Claim
16 words
37 . The method of claim 36 , further comprising attaching the device to the epicardium.
Claim 40
Dependent Claim
17 words
38 . The method of claim 37 , further comprising maintaining the device free of the pericardium.
Claim 41
Dependent Claim
20 words
39 . The method of claim 27 , further comprising delivering the device to the heart via a surgical approach.
Claim 42
Dependent Claim
20 words
40 . The method of claim 27 , further comprising delivering the device to the heart via a subthoracic approach.
Claim 43
Dependent Claim
16 words
41 . The method of claim 40 , wherein the subthoracic approach includes a subxiphoid approach.
Claim 44
Dependent Claim
16 words
42 . The method of claim 40 , wherein the subthoracic approach includes a posterior approach.
Claim 45
Dependent Claim
17 words
43 . The method of claim 27 , further comprising delivering the device via a transluminal approach.
Claim 46
Dependent Claim
30 words
44 . The method of claim 43 , wherein the transluminal approach is via the superior or inferior vena cava, the right atrium, the coronary sinus, and a cardiac vein.
Claim 47
Dependent Claim
38 words
45 . The method of claim 43 , wherein the transluminal approach is via the superior or inferior vena cava, into the right atrium or right atrial appendage, through the right atrial wall and into the pericardial space.
Claim 48
Dependent Claim
30 words
46 . The method of claim 43 , wherein the transluminal approach is via the aorta, into the left ventricle, through the left ventricular wall, and into the pericardial space.
Claim 49
Dependent Claim
17 words
47 . The method of claim 43 , wherein the transluminal approach is via the azygos vein.
Claim 50
Dependent Claim
16 words
48 . The method of claim 43 , wherein the transluminal approach is via the esophagus.
Claim 51
Dependent Claim
24 words
49 . The method of claim 27 , wherein the force exerted substantially opposite the inward force is substantially equal to the inward force.
Claim 52
Dependent Claim
18 words
50 . The method of claim 27 , wherein the inward force is exerted throughout the cardiac cycle.
Claim 53
Dependent Claim
5 words
51 - 124 . (canceled)
Claim 54
Dependent Claim
5 words
51 - 124 . (canceled)
Claim 55
Dependent Claim
75 words
125 . A system for remodeling a mitral valve annulus, comprising: a delivery catheter; an implant, detachably carried by the delivery catheter, the implant reversibly movable between a first, flexible configuration for delivery to a site adjacent the annulus of the mitral valve and a second, rigid configuration for remodeling the mitral valve annulus; and a control on the catheter for reversibly transforming the implant between the first flexible configuration and the second remodeling configuration.
Claim 56
Dependent Claim
75 words
125 . A system for remodeling a mitral valve annulus, comprising: a delivery catheter; an implant, detachably carried by the delivery catheter, the implant reversibly movable between a first, flexible configuration for delivery to a site adjacent the annulus of the mitral valve and a second, rigid configuration for remodeling the mitral valve annulus; and a control on the catheter for reversibly transforming the implant between the first flexible configuration and the second remodeling configuration.
Claim 57
Dependent Claim
20 words
126 . A system as in claim 125 , wherein the implant comprises an arc when in the remodeling configuration.
Claim 58
Dependent Claim
21 words
127 . A system as in claim 126 , wherein the implant comprises a compound curve when in the remodeling configuration.
Claim 59
Dependent Claim
17 words
128 . A system as in claim 127 , wherein the compound curve comprises a “w” configuration.
Claim 60
Dependent Claim
16 words
129 . A system as in claim 125 , further comprising a coating on the implant.
Claim 61
Dependent Claim
21 words
130 . A system as in claim 125 , further comprising an anchor for retaining the implant at a deployment site.
Claim 62
Dependent Claim
19 words
131 . A system as in claim 130 , wherein the anchor comprises a distal extension of the implant.
Claim 63
Dependent Claim
22 words
132 . A system as in claim 130 , wherein the anchor comprises a friction enhancing surface structure for engaging adjacent tissue.
Claim 64
Dependent Claim
21 words
133 . A system as in claim 130 , wherein the anchor comprises at least one barb for piercing a wall.
Claim 65
Dependent Claim
14 words
134 . A system as in claim 133 , wherein the barb is moveable.
Claim 66
Dependent Claim
109 words
135 . A method of reducing the circumference of a mitral valve annulus comprising the steps of: providing a mitral valve reducing device comprising an elongate member; positioning the elongate member in a first position at a location adjacent the atrioventricular groove and exterior of the vasculature of the heart, wherein in the first position, the elongate member has a first radius of curvature; and releasing the elongate member in the atrioventricular groove in a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature so as to reduce the circumference of the mitral valve annulus.
Claim 67
Dependent Claim
109 words
135 . A method of reducing the circumference of a mitral valve annulus comprising the steps of: providing a mitral valve reducing device comprising an elongate member; positioning the elongate member in a first position at a location adjacent the atrioventricular groove and exterior of the vasculature of the heart, wherein in the first position, the elongate member has a first radius of curvature; and releasing the elongate member in the atrioventricular groove in a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature so as to reduce the circumference of the mitral valve annulus.
Claim 68
Dependent Claim
35 words
136 . The method of claim 135 wherein the step of positioning the elongate member in a first position comprises delivering the elongate member along a coronary sinus to the location adjacent the atrioventricular groove.
Claim 69
Dependent Claim
49 words
137 . The method of claim 135 wherein the step of positioning the elongate member in a first position comprises delivering the elongate member through a coronary sinus vessel, forming an opening in the coronary sinus and delivering the elongate member out of the coronary sinus through the opening.
Claim 70
Dependent Claim
26 words
138 . The method of claim 135 wherein the step of positioning the elongate member in a first position comprises accessing and navigating the pericardial space.
Claim 71
Dependent Claim
36 words
139 . The method of claim 135 wherein the step of releasing the elongate member in the atrioventricular groove in a second position comprises bending the elongate member from the first position into the second position.
Claim 72
Dependent Claim
52 words
140 . The method of claim 139 wherein the step of providing an elongate member comprises providing an elongate member having a preferential bending mechanism at a location along a length of the elongate member; and wherein the step of bending the elongate member comprises bending the elongate member at the location.
Claim 73
Dependent Claim
19 words
141 . The method of claim 135 further comprising the step of increasing tissue adherence to the elongate member.
Claim 74
Dependent Claim
29 words
142 . The method of claim 141 wherein the step of increasing tissue adherence occurs prior to releasing the elongate member in the atrioventricular groove in the second position.
Claim 75
Dependent Claim
28 words
143 . The method of claim 141 wherein the step of increasing the tissue adherence comprises: providing a coating on the elongate member to cause a tissue response.
Claim 76
Dependent Claim
31 words
144 . The method of claim 143 wherein the step of providing a coating comprises providing a coating comprising a tissue growth promoter to cause tissue growth around the elongate member.
Claim 77
Dependent Claim
110 words
145 . A system for reducing the mitral annulus of a heart comprising: a mitral valve reducing device comprising: an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and a delivery system comprising: a catheter configured to access a pericardial space of a heart, adjacent an atrioventricular groove and outside of vasculature of the heart; and a mitral valve reducing device delivery member configured to place the reducing device in the atrioventricular groove.
Claim 78
Dependent Claim
110 words
145 . A system for reducing the mitral annulus of a heart comprising: a mitral valve reducing device comprising: an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and a delivery system comprising: a catheter configured to access a pericardial space of a heart, adjacent an atrioventricular groove and outside of vasculature of the heart; and a mitral valve reducing device delivery member configured to place the reducing device in the atrioventricular groove.
Claim 79
Dependent Claim
29 words
146 . The system of claim 145 wherein the catheter comprises a puncture wire configured to puncture a vessel in which the catheter resides to access the pericardial space.
Claim 80
Dependent Claim
28 words
147 . The system of claim 145 wherein the mitral valve reducing device comprises a preferential bending mechanism at a location along a length of the elongate member.
Claim 81
Dependent Claim
89 words
148 . A mitral valve reduction device comprising: an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature, and a bending mechanism configured to move the elongate member from the first position to the second position; and the elongate member comprising a tissue response promoter for promoting a tissue response adjacent the elongate member.
Claim 82
Dependent Claim
89 words
148 . A mitral valve reduction device comprising: an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature, a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature, and a bending mechanism configured to move the elongate member from the first position to the second position; and the elongate member comprising a tissue response promoter for promoting a tissue response adjacent the elongate member.
Claim 83
Dependent Claim
20 words
149 . The mitral valve reduction device of claim 148 wherein the tissue response promoter comprises a tissue growth promoter.
Claim 84
Dependent Claim
71 words
150 . A mitral valve reduction device comprising: an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and an end comprising a tissue engaging element configured to engage the heart within the atrioventricular groove.
Claim 85
Dependent Claim
71 words
150 . A mitral valve reduction device comprising: an elongate member having a first position wherein in the first position, the elongate member has a first radius of curvature and a second position wherein in the second position the elongate member has a second radius of curvature less than the first radius of curvature; and an end comprising a tissue engaging element configured to engage the heart within the atrioventricular groove.
Claim 86
Dependent Claim
29 words
151 . The mitral valve reduction device of claim 150 wherein the tissue engaging element comprises at least one finger member extending from the end of the elongate member.
Claim 87
Dependent Claim
29 words
152 . The mitral valve reduction device of claim 150 further comprising: a bending mechanism configured to move the elongate member from the first position to the second position.
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