US20020035361A1
Expired / Lapsed
US
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Apparatus and methods for treating tissue
Assignee: Auris Health Inc
•
Filing: 2001-07-03
•
Granted: —
•
Expires: 2021-07-03
Abstract
Abstract Apparatus and methods are provided for thermally and/or mechanically treating tissue, such as valvular structures, to reconfigure or shrink the tissue in a controlled manner. The apparatus comprises a catheter in communication with an end effector which induces a temperature rise in an annulus of tissue surrounding the leaflets of a valve or in the chordae tendineae sufficient to cause shrinkage, thereby causing the valves to close more tightly. Mechanical clips can also be implanted over the valve either alone or after the thermal treatment. The clips are delivered by a catheter and may be configured to traverse directly over the valve itself or to lie partially over the periphery of the valve to prevent obstruction of the valve channel. The clips can be coated with drugs or a radiopaque coating. The catheter can also incorporate sensors or energy delivery devices, e.g., transducers, on its distal end.
Inventors
- 👤 Russell Houser
- 👤 Vahid Sadaat
- 👤 Stephen Ramee
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 23:07
CPC Classifications
A; A61; A61B; A61B18/00; A61B17/00; A61B17/04; A61B17/0401; A61B18/04; A61B18/12; A61B18/14; A61B18/1442; A61B18/1477; A61B18/1492; A61B18/18; A61B18/20; A61B18/22; A61B18/24; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2442; A61F2/2445; A61B17/0469; A61B17/0487; A61B17/12; A61B17/122; A61B17/128; A61B17/1285; A61B17/28; A61B17/29; A61B2017/00017; A61B2017/00022; A61B2017/00084; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00831; A61B2017/00867; A61B2017/0409; A61B2017/0412; A61B2017/0414; A61B2017/0427; A61B2017/0437; A61B2017/044; A61B2017/0446; A61B2017/0448; A61B2017/0451; A61B2017/0454; A61B2017/0458; A61B2017/0461; A61B2017/0464; A61B2017/0496; A61B2017/2926; A61B2017/2945; A61B2018/00005; A61B2018/00011; A61B2018/00023; A61B2018/00053; A61B2018/00059; A61B2018/00071; A61B2018/00083; A61B2018/00214; A61B2018/0022; A61B2018/00232; A61B2018/00273; A61B2018/00315; A61B2018/00345; A61B2018/00351; A61B2018/00369; A61B2018/00636; A61B2018/00773; A61B2018/00791; A61B2018/00797; A61B18/1206; A61B2018/1246; A61B2018/1253; A61B2018/126; A61B2018/1405; A61B2018/1425; A61B2018/1432; A61B2018/1435; A61B90/00; A61B90/06; A61B2090/064; A61B90/39; A61F2/2451; A61F2/2454; A61N; A61N7/00; A61N7/02
Claims Analysis
Total Claims: 100
Claim 1
Independent Claim
68 words
1 . An apparatus for treating tissue near a valve to modify flow through the valve, comprising: a cinching member having a central region and at least two anchoring regions on opposing ends of the central region, the cinching member being configured for delivery through a catheter to the tissue whereby the cinching member has a first shape during the delivery and a second shape after the delivery.
Claim 2
Dependent Claim
68 words
1 . An apparatus for treating tissue near a valve to modify flow through the valve, comprising: a cinching member having a central region and at least two anchoring regions on opposing ends of the central region, the cinching member being configured for delivery through a catheter to the tissue whereby the cinching member has a first shape during the delivery and a second shape after the delivery.
Claim 3
Dependent Claim
19 words
2 . The apparatus of claim 1 wherein the tissue comprises an annulus of cardiac tissue surrounding the valve.
Claim 4
Dependent Claim
14 words
3 . The apparatus of claim 1 wherein the valve comprises a cardiac valve.
Claim 5
Dependent Claim
16 words
4 . The apparatus of claim 1 wherein the central region comprises a continuous alternating length.
Claim 6
Dependent Claim
16 words
5 . The apparatus of claim 1 wherein each of the anchoring regions comprise a fastener.
Claim 7
Dependent Claim
33 words
6 . The apparatus of claim 1 further comprising a plurality of additional cinching members, the cinching members being interwoven such that a plurality of spaces are defined therebetween in the second shape.
Claim 8
Dependent Claim
22 words
7 . The apparatus of claim 1 further comprising a biocompatible fastener for attaching each of the anchoring regions to the tissue.
Claim 9
Dependent Claim
41 words
8 . The apparatus of claim 7 wherein the biocompatible fastener comprises a distal end and a proximal end, the proximal end defining a projection for securing the anchoring region, and the distal end being configured for attachment to the tissue.
Claim 10
Dependent Claim
13 words
9 . The apparatus of claim 8 wherein the projection comprises an eyelet.
Claim 11
Dependent Claim
32 words
10 . The apparatus of claim 8 wherein the anchoring region is secured to the projection via a mechanical fastener selected from the group consisting of sutures, adhesives, welds, hooks, and clips.
Claim 12
Dependent Claim
31 words
11 . The apparatus of claim 8 wherein the distal end comprises a fixation device selected from the group consisting of sutures, adhesives, barbs, screws, pivoting locks, hooks, clips, and tags.
Claim 13
Dependent Claim
42 words
12 . The apparatus of claim 1 wherein the cinching member is configured to approximate a portion of periphery defined by the valve, the central region comprising an arcuate length whereby each of the anchoring regions is in apposition to each other.
Claim 14
Dependent Claim
23 words
13 . The apparatus of claim 12 wherein the portion of the periphery approximated by the cinching, member comprises at least about 50%.
Claim 15
Dependent Claim
23 words
14 . The apparatus of claim 13 wherein the portion of the periphery approximated by the cinching member comprises about 50% to 75%.
Claim 16
Dependent Claim
19 words
15 . The apparatus of claim 12 wherein each of the anchoring regions is biased towards the central region.
Claim 17
Dependent Claim
27 words
16 . The apparatus of claim 1 wherein the cinching member comprises a biocompatible material selected from the group consisting of shape memory alloys and superelastic alloys.
Claim 18
Dependent Claim
15 words
17 . The apparatus of claim 16 wherein the shape memory alloy comprises Nickel-Titanium alloy.
Claim 19
Dependent Claim
20 words
18 . The apparatus of claim 1 wherein the cinching member is at least partially coated with a coating layer.
Claim 20
Dependent Claim
15 words
19 . The apparatus of claim 18 wherein the coating layer comprises a therapeutic agent.
Claim 21
Dependent Claim
13 words
20 . The apparatus of claim 18 wherein the coating layer is hydrophilic.
Claim 22
Dependent Claim
15 words
21 . The apparatus of claim 19 wherein the therapeutic agent comprises an anti-thrombosis agent.
Claim 23
Dependent Claim
15 words
22 . The apparatus of claim 18 wherein the coating layer comprises a radiopaque layer.
Claim 24
Dependent Claim
25 words
23 . The apparatus of claim 22 wherein the radiopaque layer is selected from the group consisting of Nickel-Titanium alloy, Platinum, Palladium, Gold, and Tantalum.
Claim 25
Dependent Claim
34 words
24 . The apparatus of claim 1 wherein the central region defines a first plane and the anchoring regions define a second plane, the second plane defining an angle relative to the first plane.
Claim 26
Dependent Claim
21 words
25 . The apparatus of claim 24 wherein the central region is configured to lie over a periphery of the valve.
Claim 27
Dependent Claim
15 words
26 . The apparatus of claim 24 wherein the angle is about 60° to 120°.
Claim 28
Dependent Claim
13 words
27 . The apparatus of claim 24 wherein the angle is about 90°.
Claim 29
Dependent Claim
27 words
28 . The apparatus of claim 24 wherein the central region comprises a shape selected from the group consisting of semi-circles, arcs, half-ellipses, triangles, rectangles, and loops.
Claim 30
Dependent Claim
18 words
29 . The apparatus of claim 1 wherein each of the anchoring regions are configured to pierce tissue.
Claim 31
Dependent Claim
29 words
30 . The apparatus of claim 29 wherein each of the anchoring regions comprise a shape selected from the group consisting of semi-circles, triangles, arcs, half-ellipses, hooks, and V-shapes.
Claim 32
Dependent Claim
27 words
31 . The apparatus of claim 29 wherein each of the anchoring regions is selected from the group consisting of barbs, screws, pivoting locks, clips, and tags.
Claim 33
Dependent Claim
26 words
32 . The apparatus of claim 1 wherein the first shape comprises a geometric shape selected from the group consisting of U shapes and V shapes.
Claim 34
Dependent Claim
41 words
33 . The apparatus of claim 1 wherein the catheter comprises an elongate tubular member having a distal end and a proximal end with a lumen therebetween, the distal end defining a delivery port configured to pass the cinching member therethrough.
Claim 35
Dependent Claim
41 words
34 . The apparatus of claim 33 wherein the catheter further comprises a stylet having a distal end and a proximal end with a length therebetween, the stylet being slidingly disposed in the lumen and being manipulatable from its proximal end.
Claim 36
Dependent Claim
14 words
35 . The apparatus of claim 34 wherein the stylet distal end is angled.
Claim 37
Dependent Claim
24 words
36 . The apparatus of claim 34 wherein the catheter further comprises a linear advancement mechanism connected to the proximal end of the stylet.
Claim 38
Dependent Claim
24 words
37 . The apparatus of claim 36 wherein the linear advancement mechanism is selected from the group consisting of thumb-slides, screws, ratchets, and gears.
Claim 39
Dependent Claim
25 words
38 . The apparatus of claim 33 wherein the catheter further comprises a radiopaque tip disposed on the distal end of the elongate tubular member.
Claim 40
Dependent Claim
27 words
39 . The apparatus of claim 38 wherein the radiopaque tip comprises a metal selected from the group consisting of Nickel-Titanium alloy, Platinum, Palladium, Gold, and Tantalum.
Claim 41
Dependent Claim
22 words
40 . The apparatus of claim 38 wherein the radiopaque tip defines a lumen therethrough in communication with the elongate tubular member.
Claim 42
Dependent Claim
23 words
41 . The apparatus of claim 33 wherein the catheter further comprises a liner disposed in the lumen proximal of the distal end.
Claim 43
Dependent Claim
25 words
42 . The apparatus of claim 41 wherein the liner comprises a material selected from the group consisting of shape memory alloys and superelastic alloys.
Claim 44
Dependent Claim
31 words
43 . The apparatus of claim 33 wherein the catheter further comprises a device disposed on the distal end, the device being selected from the group consisting of sensors and transducers.
Claim 45
Dependent Claim
27 words
44 . The apparatus of claim 43 wherein the sensor is of a type selected from the group consisting of ultrasound sensors, Doppler, electrodes, and pressure sensors.
Claim 46
Dependent Claim
29 words
45 . The apparatus of claim 43 wherein the transducer is configured to deliver energy of a type selected from the group consisting of RF, electrical, and heat energy.
Claim 47
Dependent Claim
15 words
46 . The apparatus of claim 43 wherein the sensor is connected to a monitor.
Claim 48
Dependent Claim
114 words
47 . A method for treating tissue near a valve to modify flow through the valve, comprising: providing a cinching member having a central region, a first anchoring region, and a second anchoring region, each of the anchoring regions being attached to opposing ends of the central region; placing a delivery catheter near the tissue; urging the cinching member through a distal opening defined in the catheter such that the first anchoring region exits the distal opening and attaches to a first area of the tissue; and further urging the cinching member through the distal opening such that second anchoring region exits the distal opening and attaches to a second area of the tissue.
Claim 49
Dependent Claim
114 words
47 . A method for treating tissue near a valve to modify flow through the valve, comprising: providing a cinching member having a central region, a first anchoring region, and a second anchoring region, each of the anchoring regions being attached to opposing ends of the central region; placing a delivery catheter near the tissue; urging the cinching member through a distal opening defined in the catheter such that the first anchoring region exits the distal opening and attaches to a first area of the tissue; and further urging the cinching member through the distal opening such that second anchoring region exits the distal opening and attaches to a second area of the tissue.
Claim 50
Dependent Claim
19 words
48 . The method of claim 47 wherein the tissue comprises an annulus of cardiac tissue surrounding the valve.
Claim 51
Dependent Claim
14 words
49 . The method of claim 47 wherein the valve comprises a cardiac valve.
Claim 52
Dependent Claim
21 words
50 . The method of claim 47 wherein providing a cinching member further comprises providing a plurality of additional cinching members.
Claim 53
Dependent Claim
31 words
51 . The method of claim 47 further comprising providing a biocompatible fastener for attaching the first and the second anchoring regions to the first and the second areas of tissue.
Claim 54
Dependent Claim
42 words
52 . The method of claim 51 wherein the biocompatible fastener is attached to the first and the second areas of tissue via a fixation device selected from the group consisting of sutures, adhesives, barbs, screws, pivoting locks, hooks, clips, and tags.
Claim 55
Dependent Claim
18 words
53 . The method of claim 47 wherein the cinching member is comprised of a shape memory alloy.
Claim 56
Dependent Claim
15 words
54 . The method of claim 53 wherein the shape memory alloy comprises Nickel-Titanium alloy.
Claim 57
Dependent Claim
30 words
55 . The method of claim 47 wherein the first anchoring region forms a shape configured for attachment to the first area of the tissue upon exiting the distal opening.
Claim 58
Dependent Claim
24 words
56 . The method of claim 55 wherein the shape is selected from the group consisting of semi-circles, triangles, arcs, half-ellipses, hooks, and V-shapes.
Claim 59
Dependent Claim
30 words
57 . The method of claim 47 wherein the second anchoring region forms a shape configured for attachment to the second area of the tissue upon exiting the distal opening.
Claim 60
Dependent Claim
24 words
58 . The method of claim 57 wherein the shape is selected from the group consisting of semi-circles, triangles, arcs, half-ellipses, hooks, and V-shapes.
Claim 61
Dependent Claim
27 words
59 . The method of claim 47 wherein the central region forms a shape selected from the group consisting of semi-circles, arcs, half-ellipses, triangles, rectangles, and loops.
Claim 62
Dependent Claim
43 words
60 . The method of claim 47 further comprising forming a first plane defined by the central region and forming a second plane defined by the first and the second anchoring regions, the second plane defining an angle relative to the first plane.
Claim 63
Dependent Claim
15 words
61 . The method of claim 60 wherein the angle is about 60° to 120°.
Claim 64
Dependent Claim
13 words
62 . The method of claim 60 wherein the angle is about 90°.
Claim 65
Dependent Claim
30 words
63 . The method of claim 47 wherein the first anchoring region traverses the valve and attaches to the first area of the tissue located opposite of the delivery catheter.
Claim 66
Dependent Claim
26 words
64 . The method of claim 47 wherein the second anchoring region attaches to the second area of the tissue located adjacent to the delivery catheter.
Claim 67
Dependent Claim
20 words
65 . The method of claim 47 wherein the first area and the second area are located about 180° apart.
Claim 68
Dependent Claim
45 words
66 . The method of claim 47 wherein urging the cinching member through the distal opening defined in the catheter comprises advancing a stylet having a distal end and a proximal end with a length therebetween through the delivery catheter to urge the cinching member.
Claim 69
Dependent Claim
14 words
67 . The method of claim 66 wherein the stylet distal end is angled.
Claim 70
Dependent Claim
25 words
68 . The method of claim 66 wherein the stylet is advanced by a linear advancement mechanism connected at the proximal end of the stylet.
Claim 71
Dependent Claim
24 words
69 . The method of claim 68 wherein the linear advancement mechanism is selected from the group consisting of thumb-slides, screws, ratchets, and gears.
Claim 72
Dependent Claim
33 words
70 . The method of claim 47 wherein placing the delivery catheter near the tissue comprises visualizing the delivery catheter via a radiopaque tip disposed on a distal end of the delivery catheter.
Claim 73
Dependent Claim
27 words
71 . The method of claim 70 wherein the radiopaque tip comprises a metal selected from the group consisting of Nickel-Titanium alloy, Platinum, Palladium, Gold, and Tantalum.
Claim 74
Dependent Claim
41 words
72 . The method of claim 47 further comprising sensing the first area or the second area with a device disposed on a distal end of the delivery catheter, the device being selected from the group consisting of sensors and transducers.
Claim 75
Dependent Claim
27 words
73 . The method of claim 72 wherein the sensor is of a type selected from the group consisting of ultrasound sensors, Doppler, electrodes, and pressure sensors.
Claim 76
Dependent Claim
31 words
74 . The method of claim 47 further comprising delivering energy to the first area or the second area with a transducer disposed on a distal end of the delivery catheter.
Claim 77
Dependent Claim
25 words
75 . The method of claim 74 wherein the energy is of a type selected from the group consisting of RF, electrical, and heat energy.
Claim 78
Dependent Claim
137 words
76 . A system for treating tissue near a valve to modify flow through the valve, comprising: a first catheter having a distal end region, the catheter being configured for transluminal delivery of the end region to the target site; an end effector in communication with the distal end region, the end effector being configured to transfer energy to the tissue at the target site to induce thermal shrinkage of collagen in the tissue, thereby modifying flow through the valve; and a cinching member having a central region and at least two anchoring regions on opposing sides of the central region, the cinching member being configured for delivery through the first catheter or a second catheter to the tissue whereby the cinching member has a first shape during the delivery and a second shape after the delivery.
Claim 79
Dependent Claim
137 words
76 . A system for treating tissue near a valve to modify flow through the valve, comprising: a first catheter having a distal end region, the catheter being configured for transluminal delivery of the end region to the target site; an end effector in communication with the distal end region, the end effector being configured to transfer energy to the tissue at the target site to induce thermal shrinkage of collagen in the tissue, thereby modifying flow through the valve; and a cinching member having a central region and at least two anchoring regions on opposing sides of the central region, the cinching member being configured for delivery through the first catheter or a second catheter to the tissue whereby the cinching member has a first shape during the delivery and a second shape after the delivery.
Claim 80
Dependent Claim
20 words
77 . The system of claim 76 , wherein the tissue comprises an annulus of tissue surrounding a cardiac valve.
Claim 81
Dependent Claim
22 words
78 . The system of claim 77 , wherein modifying flow through the valve comprises reducing a circumference of the cardiac valve.
Claim 82
Dependent Claim
19 words
79 . The system of claim 78 , wherein the tissue comprises a support structure of a cardiac valve.
Claim 83
Dependent Claim
26 words
80 . The system of claim 79 , wherein the support structure is chosen from the group consisting of a chordae tendineae and a papillary muscle.
Claim 84
Dependent Claim
26 words
81 . The system of claim 80 , wherein modifying flow through the valve comprises shortening the chordae tendineae to properly align leaflets of the valve.
Claim 85
Dependent Claim
22 words
82 . The system of claim 76 , wherein the tissue at the target site comprises a leaflet of a cardiac valve.
Claim 86
Dependent Claim
33 words
83 . The system of claim 76 further comprising a plurality of additional cinching members, the cinching members being interwoven such that a plurality of spaces are defined therebetween in the second shape.
Claim 87
Dependent Claim
22 words
84 . The system of claim 76 further comprising a biocompatible fastener for attaching each of the anchoring regions to the tissue.
Claim 88
Dependent Claim
42 words
85 . The system of claim 76 wherein the cinching member is configured to approximate a portion of periphery defined by the valve, the central region comprising an arcuate length whereby each of the anchoring regions is in apposition to each other.
Claim 89
Dependent Claim
23 words
86 . The system of claim 85 wherein the portion of the periphery approximated by the cinching member comprises at least about 50%.
Claim 90
Dependent Claim
23 words
87 . The system of claim 86 wherein the portion of the periphery approximated by the cinching member comprises about 50% to 75%.
Claim 91
Dependent Claim
19 words
88 . The system of claim 85 wherein each of the anchoring regions is biased towards the central region.
Claim 92
Dependent Claim
27 words
89 . The system of claim 76 wherein the cinching member comprises a biocompatible material selected from the group consisting of shape memory alloys and superelastic alloys.
Claim 93
Dependent Claim
15 words
90 . The system of claim 89 wherein the shape memory alloy comprises Nickel-Titanium alloy.
Claim 94
Dependent Claim
34 words
91 . The system of claim 76 wherein the central region defines a first plane and the anchoring regions define a second plane, the second plane defining an angle relative to the first plane.
Claim 95
Dependent Claim
15 words
92 . The system of claim 91 wherein the angle is about 60° to 120°.
Claim 96
Dependent Claim
13 words
93 . The system of claim 91 wherein the angle is about 90°.
Claim 97
Dependent Claim
27 words
94 . The system of claim 91 wherein the central region comprises a shape selected from the group consisting of semi-circles, arcs, half-ellipses, triangles, rectangles, and loops.
Claim 98
Dependent Claim
19 words
95 . The system of claim 76 wherein each of the anchoring regions are configured to pierce the tissue.
Claim 99
Dependent Claim
29 words
96 . The system of claim 95 wherein each of the anchoring regions comprise a shape selected from the group consisting of semi-circles, triangles, arcs, half-ellipses, hooks, and V-shapes.
Claim 100
Dependent Claim
27 words
97 . The apparatus of claim 95 wherein each of the anchoring regions is selected from the group consisting of barbs, screws, pivoting locks, clips, and tags.
References Cited (Backward Citations)
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