Methods and devices for heart valve repair
Inventors
Sirhan, Motasim • Bhat, Vinayak • Paraschac, Joseph • Serna, Benjamyn • Yan, John
Assignees
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Publication Number
US-11191656-B2
Publication Date
2021-12-07
Expiration Date
Abstract
A system for reshaping a valve annulus includes an elongate template having a length along a longitudinal axis and at least one concavity in a generally lateral direction along said length. The pre-shaped template is positioned against at least a region of an inner peripheral wall of the valve annulus, and at least one anchor on the template is advanced into a lateral wall of the valve annulus to reposition at least one segment of the region of the inner peripheral wall of the valve annulus into said concavity. In this way, a peripheral length of the valve annulus can be foreshortened and/or reshaped to improve coaption of the valve leaflets and/or to eliminate or decrease regurgitation of a valve.
Core Innovation
The invention relates to an implant for reshaping a valve annulus. The implant includes a pre-shaped template having a tissue-engaging surface with first and second convex regions joined by at least one concave region, and the pre-shaped template extends between a first terminal end comprising the first convex region and a second terminal end comprising the second convex region.
The implant further includes at least one rotatable anchor configured to penetrate tissue when rotated. The pre-shaped template is coupled to the at least one rotatable anchor, and the pre-shaped template is configured to draw at least one segment of a valve annulus into the concave region. This drawing of an annulus segment into the concave region enables valve annulus reshaping intended to affect valve function via leaflet coaptation and reduced regurgitation.
The disclosure also describes template and anchor geometries and delivery variations to enable the template to capture and reshape peripheral wall segments. The template can include symmetric or asymmetric concavities and multiple concave regions joined to convex regions, and anchor forms include rotatable helix, screw, coil/spiral, and related configurations.
Claims Coverage
The independent claim set includes 1 independent claim, defining an implant that reshapes a valve annulus by coupling a pre-shaped template with convex and concave regions to at least one rotatable anchor that penetrates tissue when rotated. The claim is structured around inventive features comprising the pre-shaped template geometry and the rotatable anchor-coupling that draws an annulus segment into a concave region.
Pre-shaped template with convex regions joined by concave region(s)
A pre-shaped template having a tissue-engaging surface having first and second convex regions joined by at least one concave region, wherein the pre-shaped template extends between a first terminal end comprising the first convex region and a second terminal end comprising the second convex region.
Rotatable anchor that penetrates tissue when rotated
At least one rotatable anchor configured to penetrate tissue when rotated.
Template coupled to rotatable anchor to draw annulus segment into concavity
The pre-shaped template is configured to be coupled to the at least one rotatable anchor and wherein the pre-shaped template is configured to draw at least one segment of a valve annulus into the concave region.
Across the independent claim, the inventive core is the coupling of a pre-shaped template with convex-to-concave tissue-engaging geometry to a rotatable tissue-penetrating anchor, so that the coupled template draws at least one segment of the valve annulus into the concave region to achieve valve annulus reshaping.
Stated Advantages
Improves leaflet coaptation.
Reduces regurgitation.
Documented Applications
Implantation workflows for valve annulus reshaping, including described example implantation and referenced trans-septal catheterization workflows.
Measurements of annulus dimension change in vivo or ex vivo, including area, circumference, and minor-axis.
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