Devices, systems, and methods for supplementing, repairing, or replacing a native heart valve leaflet
First Claim
1. A method comprising the steps ofproviding an implant comprisinga scaffold, at least a portion of the scaffold defining a pseudo-annulus, the scaffold comprising a normal, unloaded condition and an elastically loaded condition,at least two struts, the struts having a connecting member and a tab segment, wherein the struts are coupled to the scaffold by the connecting members and are positioned in generally oppositely spaced apart positions,a first neoleaflet element coupled to the scaffold, the neoleaflet element comprising a first material spanning at least a first portion of the pseudo annulus,introducing the implant into a heart, wherein the heart includes a valve having a native valve annulus with an upstream and downstream side, the valve further having at least one native leaflet joined at leaflet commissures to tissue that surrounds the native valve annulus,positioning the pseudo-annulus defined by the scaffold adjacent to the upstream side of the native valve annulus,positioning the neoleaflet element in an at least partially overlapping relationship with at least one of the at least one native leaflets,placing the strut tab segments into engagement with the tissue at or near the native leaflet commissures, andallowing external compression forces to place the elastic scaffold into the elastically loaded condition,whereby force exerted on the tissue by the struts reshapes the native valve annulus.
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Accused Products
Abstract
An implant for supplementing, repairing, or replacing a native heart valve leaflet or leaflets provides a scaffold, which defines a pseudo-annulus. The implant further has at least two struts in generally oppositely spaced apart positions on the scaffold. The scaffold can be placed in an elastically loaded condition in a heart with the struts engaging tissue at or near the leaflet commissures of a heart valve annulus, to reshape the annulus for leaflet coaptation. The implant further provides a neoleaflet element coupled to the scaffold within pseudo-annulus, to provide a one-way valve function.
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Citations
12 Claims
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1. A method comprising the steps of
providing an implant comprising a scaffold, at least a portion of the scaffold defining a pseudo-annulus, the scaffold comprising a normal, unloaded condition and an elastically loaded condition, at least two struts, the struts having a connecting member and a tab segment, wherein the struts are coupled to the scaffold by the connecting members and are positioned in generally oppositely spaced apart positions, a first neoleaflet element coupled to the scaffold, the neoleaflet element comprising a first material spanning at least a first portion of the pseudo annulus, introducing the implant into a heart, wherein the heart includes a valve having a native valve annulus with an upstream and downstream side, the valve further having at least one native leaflet joined at leaflet commissures to tissue that surrounds the native valve annulus, positioning the pseudo-annulus defined by the scaffold adjacent to the upstream side of the native valve annulus, positioning the neoleaflet element in an at least partially overlapping relationship with at least one of the at least one native leaflets, placing the strut tab segments into engagement with the tissue at or near the native leaflet commissures, and allowing external compression forces to place the elastic scaffold into the elastically loaded condition, whereby force exerted on the tissue by the struts reshapes the native valve annulus.
Specification
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- Resources
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Current AssigneeMVRx, Inc.
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Original AssigneeMVRx, Inc.
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InventorsSoss, Rick A., Machold, Timothy R., Rahdert, David A., Chang, Robert T., Macoviak, John A.
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Primary Examiner(s)Stewart; Alvin J.
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Application NumberUS11/981,025Publication NumberTime in Patent Office1,413 DaysField of Search623 211- 214, 623/2.18, 623/1.24, 623/1.26, 606/127, 606/158, 606/194, 606/200US Class Current623/2.36CPC Class CodesA61F 2/2418 Scaffolds therefor, e.g. su...A61F 2/2445 Annuloplasty rings in direc...A61F 2/2454 Means for preventing invers...
