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US20030120341A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Devices and methods of repairing cardiac valves

Assignee: VALFIX
•
Filing: 2001-12-21
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Granted: —
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Expires: 2021-12-21
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Abstract

Abstract Devices and methods are provided for securing leaflets of a cardiac valve together. The subject devices include an assembly having a fastener, means for temporarily securing the fastener to the leaflets and means for permanently securing the fastener to the leaflets and means for anchoring the fastener to the heart wall. The subject methods are characterized by temporarily grasping the leaflets of a valve together at an apposition point, assessing at least one of blood flow and pressure gradient across said valve, determining whether to permanently secure the valve leaflets at said selected apposition point based upon at least one of the measured blood flow and pressure gradient, and performing one of permanently attaching the leaflets together at the apposition site or releasing the grasped leaflets. Also included are assemblies which include a subject device and a delivery device and may include a pressure monitoring member and/or a flow monitoring member. Kits which include the subject devices are also provided.

Inventors

  • 👤 Hani Shennib
  • 👤 Albert Burdulis

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 13:55
CPC Classifications
A; A61; A61B; A61B5/00; A61B5/02; A61B5/021; A61B5/0215; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2442; A61F2/2454; A61F2/2457; A61B17/00; A61B17/12; A61B17/122; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00681; A61B2017/00685; A61B2017/00743; A61B2017/00778; A61B2017/00783; A61B17/04; A61B17/0401; A61B2017/0404; A61B2017/0417

Claims Analysis

Total Claims: 31
Claim 1
Independent Claim 47 words
1 . An assembly for securing leaflets of a cardiac valve together at a point of apposition between the valve leaflets, said assembly comprising: a fastener; a means for temporarily securing said fastener to said leaflets; and a means for permanently securing said fastener to said leaflets.
Claim 2
Dependent Claim 47 words
1 . An assembly for securing leaflets of a cardiac valve together at a point of apposition between the valve leaflets, said assembly comprising: a fastener; a means for temporarily securing said fastener to said leaflets; and a means for permanently securing said fastener to said leaflets.
Claim 3
Dependent Claim 27 words
2 . The assembly according to claim 1 , further comprising a delivery sheath for delivering said fastener from outside a patient's body to said valve leaflets.
Claim 4
Dependent Claim 24 words
3 . The assembly according to claim 2 , wherein said sheath is selected from the group consisting of a catheter and a cannula.
Claim 5
Dependent Claim 27 words
4 . The assembly according to claim 1 , wherein said assembly further includes at least one of a pressure monitoring probe and a flow monitoring probe.
Claim 6
Dependent Claim 35 words
5 . The assembly according to claim 4 , wherein at least one of said pressure monitoring probe and said flow monitoring probe is configured to be delivered through a lumen of said delivery sheath.
Claim 7
Dependent Claim 24 words
6 . The assembly according to claim 2 , wherein said delivery sheath comprises said means for temporarily securing said fastener to said leaflets.
Claim 8
Dependent Claim 22 words
7 . The assembly according to claim 2 wherein said fastener comprises said means for permanently securing said fastener to said leaflets.
Claim 9
Dependent Claim 17 words
8 . The assembly according to claim 1 further comprising an anchoring mechanism attached to said fastener.
Claim 10
Dependent Claim 96 words
9 . A method for securing together leaflets of a cardiac valve of a heart having an apex, said method comprising: (a) temporarily grasping the leaflets of a valve together at a selected apposition point; (b) measuring at least one of blood flow and pressure gradient across said valve; (c) determining whether to permanently secure said valve leaflets at said selected apposition point based upon at least one of said measured blood flow and pressure gradient; and (d) performing one of permanently securing said leaflets together at said selected apposition site or releasing said grasped leaflets.
Claim 11
Dependent Claim 96 words
9 . A method for securing together leaflets of a cardiac valve of a heart having an apex, said method comprising: (a) temporarily grasping the leaflets of a valve together at a selected apposition point; (b) measuring at least one of blood flow and pressure gradient across said valve; (c) determining whether to permanently secure said valve leaflets at said selected apposition point based upon at least one of said measured blood flow and pressure gradient; and (d) performing one of permanently securing said leaflets together at said selected apposition site or releasing said grasped leaflets.
Claim 12
Dependent Claim 34 words
10 . The method according to claim 9 , further comprising, prior to said step (a), measuring one of at least blood flow and pressure gradient across said valve to obtain a baseline measurement(s).
Claim 13
Dependent Claim 23 words
11 . The method according to claim 10 , wherein step (c) comprises comparing said measurement(s) of step (b) with said baseline measurement(s).
Claim 14
Dependent Claim 17 words
12 . The method according to claim 9 , further comprising repeating said steps (a) through (d).
Claim 15
Dependent Claim 34 words
13 . The method according to claim 12 , wherein said steps (a) through (d) are repeated until the measurement(s) of step (b) indicates that the functioning of said valve leaflets is sufficiently improved.
Claim 16
Dependent Claim 20 words
14 . The method according to claim 9 wherein said method is performed using the assembly of claim 1 .
Claim 17
Dependent Claim 19 words
15 . The method according to claim 9 wherein said method is performed by means of an endovascular approach.
Claim 18
Dependent Claim 19 words
16 . The method according to claim 9 wherein said method is performed by means of a surgical approach.
Claim 19
Dependent Claim 25 words
17 . The method according to claim 16 further comprising accessing said cardiac valve through an entry site formed within the apex of the heart.
Claim 20
Dependent Claim 18 words
18 . The method according to claim 9 wherein said method is performed while the heart is beating.
Claim 21
Dependent Claim 102 words
19 . A method for repairing a regurgitating cardiac valve having at least two opposing leaflets, said method comprising: (a) providing the assembly of claim 1; (b) delivering said fastener to said leaflets; (c) selecting a point of apposition between said leaflets; (d) temporarily causing said fastener to grasp said leaflets at said selected point of apposition; and (e) assessing at least one of blood flow and pressure gradient across said leaflets; and (f) determining whether to permanently secure said fastener to said leaflets at said selected apposition point based upon at least one of said assessed blood flow and pressure gradient.
Claim 22
Dependent Claim 53 words
20 . The method according to claim 19 , upon determining not to permanently secure said fastener to said leaflets at said selected apposition point, further comprising: (g) causing said fastener to release said grasped leaflets; (h) selecting a second point of apposition between said leaflets; (i) repeating steps (d), (e) and (f).
Claim 23
Dependent Claim 22 words
21 . The method according to claim 19 , further comprising: (g) permanently securing said leaflets together at said selected apposition site.
Claim 24
Dependent Claim 25 words
22 . The method according to claim 21 , further comprising: (h) repeating steps (a) through (f) for one or more additional selected apposition sites.
Claim 25
Dependent Claim 22 words
23 . The method according to claim 21 , further comprising: (h) anchoring said fastener to a location on the cardiac anatomy.
Claim 26
Dependent Claim 18 words
24 . The method according to claim 23 , wherein said fastener is anchored to the ventricle wall.
Claim 27
Dependent Claim 24 words
25 . The method according to claim 19 , wherein said steps (b), (c) and (d) are performed with the assistance of transesophageal echocardiogram.
Claim 28
Dependent Claim 20 words
26 . The method according to claim 19 , wherein said blood flow is assessed by means of transesophageal echocardiogram.
Claim 29
Dependent Claim 24 words
27 . A kit for repairing a cardiac valve, said kit comprising; an assembly according to claim 1; and a plurality of said fasteners.
Claim 30
Dependent Claim 24 words
28 . The kit according to claim 27 further comprising a fastener delivery sheath configured for endovascularly delivering said fastener to said cardiac valve.
Claim 31
Dependent Claim 34 words
29 . The kit according to claim 27 further comprising a fastener delivery sheath configured for delivering said fastener to said cardiac valve through a surgical opening within the chest cavity of a patient.

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