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US20050010287A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Devices, systems, and methods for supplementing, repairing, or replacing a native heart valve leaflet

Assignee: Ample Medical Inc
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Filing: 2003-10-01
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Granted: —
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Expires: 2023-10-01
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Abstract

Abstract Devices, systems and methods supplement, repair, or replace a native heart valve. The devices, systems, and methods employ an implant that, in use, extends adjacent a valve annulus. The implant includes a mobile neoleaflet element that occupies the space of at least a portion of one native valve leaflet. The implant mimics the one-way valve function of a native leaflet, to resist or prevent retrograde flow. The implant restores normal coaptation of the leaflets to resist retrograde flow, thereby resisting eversion and/or prolapse, which, in turn, reduces regurgitation.

Inventors

  • 👤 John Macoviak
  • 👤 Robert Chang
  • 👤 David Rahdert
  • 👤 Timothy Machold
  • 👤 Rick Soss

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 04:10
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2442; A61F2/2445; A61F2/2454; A61F2/2412; A61F2/2418

Claims Analysis

Total Claims: 25
Claim 1
Independent Claim 148 words
1 . An implant that supplements, repairs, or replaces a native heart valve leaflet or leaflets comprising a scaffold sized and configured to rest adjacent all or a portion of a native heart valve annulus, at least a portion of the scaffold defining a pseudo-annulus, a neoleaflet element coupled to the scaffold within pseudo-annulus and being sized and shaped to occupy the space of at least a portion of one native heart valve leaflet to provide a one-way valve function that, in response to a first pressure condition, assumes a valve opened condition within the pseudo-annulus and, in response to a second pressure condition, assumes a valve closed condition within the pseudo-annulus, and spaced-apart struts appended to the scaffold and being sized and configured to contact tissue near or within the heart valve annulus to brace the scaffold against migration within the annulus during the one-way valve function.
Claim 2
Dependent Claim 148 words
1 . An implant that supplements, repairs, or replaces a native heart valve leaflet or leaflets comprising a scaffold sized and configured to rest adjacent all or a portion of a native heart valve annulus, at least a portion of the scaffold defining a pseudo-annulus, a neoleaflet element coupled to the scaffold within pseudo-annulus and being sized and shaped to occupy the space of at least a portion of one native heart valve leaflet to provide a one-way valve function that, in response to a first pressure condition, assumes a valve opened condition within the pseudo-annulus and, in response to a second pressure condition, assumes a valve closed condition within the pseudo-annulus, and spaced-apart struts appended to the scaffold and being sized and configured to contact tissue near or within the heart valve annulus to brace the scaffold against migration within the annulus during the one-way valve function.
Claim 3
Dependent Claim 15 words
2 . An implant according to claim 1 wherein the scaffold comprises a wire-form structure.
Claim 4
Dependent Claim 19 words
3 . An implant according to claim 1 wherein at least one of the struts comprises a wire-form structure.
Claim 5
Dependent Claim 19 words
4 . An implant according to claim 1 wherein the scaffold and the struts each comprises a wire-form structure.
Claim 6
Dependent Claim 19 words
5 . An implant according to claim 1 wherein the neoleaflet element includes a bridge appended to the scaffold.
Claim 7
Dependent Claim 18 words
6 . An implant according to claim 5 wherein the neoleaflet element includes a material covering the bridge.
Claim 8
Dependent Claim 15 words
7 . An implant according to claim 5 wherein the bridge is a wire-form structure.
Claim 9
Dependent Claim 19 words
8 . An implant according to claim 1 wherein the neoleaflet element includes a duckbill valve within the psuedo-annulus.
Claim 10
Dependent Claim 18 words
9 . An implant according to claim 1 wherein the neoleaflet element includes a membrane within the pseudo-annulus.
Claim 11
Dependent Claim 28 words
10 . An implant according to claim 1 wherein the neoleaflet element is sized and configured to coapt with a native leaflet when in the valve closed condition.
Claim 12
Dependent Claim 23 words
11 . An implant according to claim 1 wherein the scaffold, neoleaflet element, and the struts are collapsible for placement within a catheter.
Claim 13
Dependent Claim 36 words
12 . An implant according to claim 1 wherein at least one of the struts carries a structure sized and configured to increase a surface area of contact with tissue at, above, or below the annulus.
Claim 14
Dependent Claim 38 words
13 . An implant according to claim 1 further including at least one structure appended to the scaffold and being sized and configured to contact tissue at, above, or below the heart valve annulus to stabilize the scaffold.
Claim 15
Dependent Claim 35 words
14 . An implant according to claim 1 wherein the scaffold, neoleaflet element, and struts include materials and shapes to provide a spring-like bias for compliance with anatomy near or within the heart valve annulus.
Claim 16
Dependent Claim 15 words
15 . An implant according to claim 1 wherein the struts apply tension to tissue.
Claim 17
Dependent Claim 21 words
16 . An implant according to claim 1 wherein the struts apply tension to tissue to reshape the heart valve annulus.
Claim 18
Dependent Claim 24 words
17 . An implant according to claim 1 wherein the struts apply tension to separate tissue along an axis of the heart valve annulus.
Claim 19
Dependent Claim 26 words
18 . An implant according to claim 1 further including a second heart valve treatment element appended to the scaffold to affect a heart valve function.
Claim 20
Dependent Claim 26 words
19 . An implant according to claim 18 wherein the second heart valve treatment element includes means for reshaping the heart valve annulus for leaflet coaptation.
Claim 21
Dependent Claim 24 words
20 . An implant according to claim 18 wherein the second heart valve treatment element includes means for stretching leaftlet commissures for leaflet coaptation.
Claim 22
Dependent Claim 148 words
21 . A method for supplementing, repairing, or replacing a native heart valve leaflet or leaflets comprising the steps of introducing an implant as defined in claim 1 into a heart, and providing a one-way valve function that, in response to a first pressure condition, assumes a valve opened condition and, in response to second pressure condition, assumes a valve closed condition by locating the scaffold as defined in claim 1 adjacent all or a portion of a native heart valve annulus to define a pseudo-annulus, with the neoleaflet element as defined in claim 1 occupying the space of at least a portion of one native heart valve leaflet to provide the one-way valve function, and with the spaced-apart struts as defined in claim 1 contacting tissue near or within the heart valve annulus to brace the scaffold against migration within the annulus during the one-way valve function.
Claim 23
Dependent Claim 19 words
22 . A method according to claim 21 wherein the introducing step comprises using an open heart surgical procedure.
Claim 24
Dependent Claim 26 words
23 . A method according to claim 21 wherein the introducing step comprises using a surgical procedure in which the implant is carried within a catheter.
Claim 25
Dependent Claim 18 words
24 . A method according to claim 21 wherein the introducing step comprises using an intravascular surgical procedure.

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