Method and catheter for creating an interatrial aperture

Inventors

Vardi, Gil M.Minar, Chris

Assignees

Intershunt Technologies Inc

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Publication Number

US-10993736-B2

Patent

Publication Date

2021-05-04

Expiration Date


Abstract

A catheter device 10 with a cutting structure or means 16 on the distal portion 14 is disclosed, along with a medical procedure for using the device. The catheter 10 is configured in such a way as to create a permanent interatrial aperture in the heart, including creating a permanent interatrial hole and/or removing tissue.

Core Innovation

The invention relates to catheters and medical device assemblies for creating a durable interatrial aperture in the interatrial septum. A shaped blade is oriented at a substantially right angle to a longitudinal axis of the catheter and is configured to cut a 3 mm or larger durable aperture in the interatrial septum.

The device includes proximal and distal tissue retention devices that cooperate with the blade. An actuator changes a relative position between the proximal and distal tissue retention devices to alter tissue positioning for cutting and removal of tissue from the interatrial septum.

The sheath and catheter are configured to enable substantially perpendicular blade-to-tissue interaction, and the assembly includes visualization markers and, in some embodiments, a force sensor for determining force applied to tissue.

Claims Coverage

The provided independent claims are clm-00001, clm-00015, and clm-00020. Across these independent claims, the coverage centers on a substantially right-angle shaped blade cutting a 3 mm or larger durable aperture in the interatrial septum, combined with proximal and distal tissue retention devices whose relative position is changed by an actuator, and additional alignment and adjustment components.

Right-angle shaped blade for durable interatrial aperture

A blade cutting edge oriented at a substantially right angle to a longitudinal axis and configured to cut a 3 mm or larger durable aperture in the interatrial septum.

Proximal and distal tissue retention devices with actuated relative position

A proximal tissue retention device, a distal tissue retention device, and an actuator configured to change a relative position between the proximal and distal tissue retention devices.

Tissue capture by retention devices

Proximal and distal tissue retention devices configured to hold tissue against the blade cutting edge and to apply force to capture the tissue between them.

Blade riding over outside edge of retention devices

The blade cutting edge is adapted to ride over an outside edge of proximal and distal tissue retention devices to cut the tissue.

Perpendicular alignment means for cutting

Means for aligning the blade with a tissue to be cut in a substantially perpendicular manner.

Adjustable amount of tissue cut from the interatrial septum

Means to adjust the amount of tissue cut from an interatrial septum.

Catheter with distal cutter and distal tissue capture mechanism

An elongated shaft having a cutter at its distal end and having a tissue capture mechanism at its distal end, together with a handle at the proximal end.

The independent claims collectively cover a catheter-based assembly that uses a shaped blade with a substantially right-angle cutting edge to cut a 3 mm or larger durable aperture in the interatrial septum, while using proximal and distal tissue retention devices actuated relative to each other to position and capture tissue, and including alignment and adjustable tissue-cutting amount functionality.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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