US2020188101A1PendingUtilityA1

Devices, systems and methods for cardiac treatment

Assignee: 4C MEDICAL TECHNOLOGIES INCPriority: Feb 20, 2015Filed: Feb 25, 2020Published: Jun 18, 2020
Est. expiryFeb 20, 2035(~8.6 yrs left)· nominal 20-yr term from priority
A61F 2/2487A61F 2/2439A61F 2/2436A61F 2/243A61F 2/2418A61F 2/2412A61F 2/2409
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Claims

Abstract

A device for providing cardiac treatment at the left atrium of a patient's heart. The device includes a retention body and a prosthetic valve. The retention body has a shape that can be manipulated between a collapsed state and a normal or expanded state. First and second openings are defined at one side of the retention body, and a lower opening is defined at an opposite side. The prosthetic valve is carried by the retention body at the lower opening. The retention body is configured to engage a substantial portion of an interior surface of the left atrium, securing the prosthetic valve at a desired location relative to a native mitral valve (e.g., within the mitral valve or slightly spaced from the mitral valve). The first and second openings are sized and shaped so as to permit blood flow from the pulmonary veins into the interior region.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A device for implantation within a patient's left atrium having a size and shape defined by at least an atrial roof and walls and an annulus having an upper surface, the device adapted to supplement and/or replace the native mitral valve leaflet functionality, the device comprising:
 a retention body comprising a self-expanding and collapsible stent defining an interior, a first side and a second side and comprising:   an expandable and collapsible base section having an outer surface and an inner surface, wherein the outer surface of the base section comprises a lowermost surface of the device;   a lower opening disposed at the first side of the retention body;   at least one support member attached to the second side of the retention body opposite the first side;   an upper support member top attached to the at least one support member that, when implanted, is in contact with the atrial roof, the at least one support member biased to press the upper support member top against the atrial roof; and a prosthetic valve comprising a plurality of prosthetic leaflets, wherein the prosthetic valve is disposed entirely within the interior of the base section and proximate the lower opening disposed at the first side of the retention body such that the prosthetic valve is spaced above the lowermost surface of the device,   wherein the retention body is arranged to achieve at least one biased expanded state and a collapsed state; and   wherein the upper support member top is urged against the atrial roof of the left atrium, the first side of the retention body is urged against the upper surface of the annulus, and the base section is urged against the walls of the left atrium and thereby are configured to hold the expanded device in position within the chamber only by a combination of pressured and frictional fit positioning,   wherein, when expanded within the left atrium, the device is configured to be completely retained within the left atrium and wherein the prosthetic valve is configured to be spaced away from the native mitral valve leaflets.   
     
     
         2 . The device of  claim 1 , wherein the retention body is arranged to achieve at least one biased expanded state and a collapsed state, the at least one biased expanded state comprising a retention body size and shape that at least partially conforms with the size and shape of the heart chamber. 
     
     
         3 . The device of  claim 1 , wherein the upper support member top consists of one of a non-compliant and a compliant material. 
     
     
         4 . The device of  claim 1 , wherein the upper support member top comprises a memory shape material. 
     
     
         5 . The device of  claim 4 , wherein the upper support member top comprises nitinol. 
     
     
         6 . The device of  claim 5 , wherein the memory shape material comprises nitinol formed into loops. 
     
     
         7 . The device of  claim 1 , further comprising a covering over the upper support member top. 
     
     
         8 . The device of  claim 7 , wherein the covering comprises at least one of the group consisting of: tissue and fabric. 
     
     
         9 . The device of  claim 1 , wherein the upper support member top is an open structure. 
     
     
         10 . The device of  claim 9 , wherein the open structure consists of one of a compliant and a non-compliant material. 
     
     
         11 . The device of  claim 9 , wherein the open structure comprises a memory shape material. 
     
     
         12 . The device of  claim 11 , wherein the open structure comprises nitinol. 
     
     
         13 . The device of  claim 12 , wherein the memory shape material comprises nitinol formed into loops. 
     
     
         14 . The device of  claim 9 , wherein the open structure is covered by at least one of the group consisting of: tissue and fabric. 
     
     
         15 . The device of  claim 1 , wherein the base section comprises an expanding compliant material. 
     
     
         16 . The device of  claim 1 , further comprising a liner over the base section. 
     
     
         17 . The device of  claim 1 , the retention body comprising a shape memory material. 
     
     
         18 . The device of  claim 1 , wherein the shape memory material comprises nitinol. 
     
     
         19 . The device of  claim 1 , the retention body comprising expanding springs. 
     
     
         20 . The device of  claim 1 , wherein at least part of the outer surface of the base section comprises a liner. 
     
     
         21 . The device of  claim 20 , wherein the liner comprises at least one of the group consisting of: a fabric, a polymer, a metal mesh, braided material, amnion tissue, placental tissue, pericardium tissue, small intestine tissue, and an anti-thrombotic material. 
     
     
         22 . The device of  claim 21 , wherein the liner is in direct, intimate and sealed contact with the atrial walls. 
     
     
         23 . The device of  claim 1 , further comprising a skirt attached to the base proximate the lower opening and extending radially outwardly around the base section. 
     
     
         24 . The device of  claim 1 , wherein the outer surface of the base section is configured to be in covered and sealed engagement over the left atrial appendage located in the left atrium. 
     
     
         25 . The device of  claim 20 , wherein the liner is configured to cover the left atrial appendage located in the left atrium. 
     
     
         26 . The device of  claim 23 , wherein the skirt is configured to cover the left atrial appendage located in the left atrium. 
     
     
         27 . The device of  claim 1 , wherein the prosthetic valve is configured to be spaced above the native mitral valve leaflets.

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