Devices, systems, and methods for treating heart failure

Inventors

Fazio, GeorgeFinch, MatthewMitzel, John

Assignees

Corvia Medical Inc

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Publication Number

US-9775636-B2

Patent

Publication Date

2017-10-03

Expiration Date


Abstract

The present teachings provide devices and methods for percutaneously removing internal tissue. Specifically, one aspect of the present teachings provides a tissue incising element with a sharp cutting edge and a longitudinal lumen and a tissue stabilizer slidably disposed within the longitudinal lumen of the tissue incising element. The tissue incising element has a deployed configuration during tissue cutting and a small collapsed configuration during the percutaneous delivery and removal. The tissue stabilizer includes a tissue supporting/gripping element configured to support tissue during incising and capture the removed tissue.

Core Innovation

The disclosed invention provides a transseptal tissue coring device for treating heart failure by creating an interatrial shunt via percutaneous transseptal tissue coring. The device includes a tissue incising element with a sharp distal cutting edge and a longitudinal lumen extending to the distal end. A tissue stabilizer is provided with a supporting surface that cooperates with the incising element.

In the deployed configuration, the supporting surface is positioned relative to the cutting edge to stabilize and support coring of tissues. The tissue stabilizer includes a tubular body having slits that extend substantially from a proximal end to a distal end, and the deployed supporting surface is formed by radially expandable tissue supporting struts created by the slits. The supporting surface is substantially parallel to a surface formed by the deployed cutting edge and is greater than the dimension of the deployed cutting edge.

The device geometry specifies that at least one dimension of the cutting edge in the deployed profile is up to 400% of that in the delivery profile. The cutting edge is capable of applying a force against the supporting surface in the deployed profile to cut tissues, and the framework supports deploying and retrieving tissue-coring structure in a delivery profile and a deployed profile, including capturing removed septal tissue for the transseptal procedure.

Claims Coverage

Two independent claims are covered. The independent claim set centers on a transseptal tissue coring device with a cutting edge and a supporting surface that each have delivery and deployed profiles with a large deployed-to-delivery dimensional ratio, and with structural alignment between a sharp cutting edge and a slit-derived supporting surface, the supporting surface dimension being greater than the cutting edge dimension.

Expanded cutting edge with delivery and deployed profiles

At least one dimension of the cutting edge in the deployed profile is up to 400% of that in the delivery profile, and the cutting edge in the deployed profile is capable of applying a force against the supporting surface in the deployed profile to cut tissues.

Slit-derived supporting surface parallel to cutting edge

The supporting surface is derived from a tubular body having a proximal end, a distal end, and a plurality of slits extending substantially from the proximal end to the distal end, wherein the deployed supporting surface is substantially parallel to a surface formed by the deployed cutting edge and is greater than the dimension of the deployed cutting edge.

Tissue incising element with sharp distal edge and longitudinal lumen

A transseptal tissue coring device comprising a tissue incising element comprising a proximal end, a distal end, a longitudinal lumen extending from the proximal end to the distal end, and a sharp edge at the distal end.

Tissue stabilizer with slit-formed supporting struts

A tissue stabilizer comprising an elongated body, a distal portion, and a plurality of tissue supporting struts formed by a plurality of slits along the elongated body of the distal portion of the tissue stabilizer, wherein the tissue supporting struts form a supporting surface, wherein the supporting surface is substantially parallel to a surface formed by the sharp edge of the tissue incising element and is greater than the dimension of the sharp edge of the tissue incising element.

Overall, the independent claims require a transseptal tissue coring device in which a deployed cutting edge applies force against a deployed supporting surface, with a slit-derived supporting surface oriented substantially parallel to the cutting edge surface and having a dimension greater than the cutting edge dimension; one claim further specifies that a cutting edge dimension in the deployed profile is up to 400% of that in the delivery profile.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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