Method and catheter for creating an interatrial aperture
Inventors
Assignees
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Publication Number
US-12539137-B2
Publication Date
2026-02-03
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 is directed to a catheter-based medical device assembly that creates a durable or permanent interatrial aperture by cutting an interatrial septum. The assembly includes a first delivery catheter with an RF cutter on a distal end, where the RF electrode is configured to cut a 3 mm or larger durable aperture in an interatrial septum.
The invention also includes tissue retention structures and an actuator that changes a relative position between proximal and distal tissue retention devices to secure, retain, and position the interatrial septum during cutting. A proximal tissue retention device and a distal tissue retention device work together so the septum is retained between them, including embodiments in which cut tissue is retained in a cutter lumen and a barb tents a portion of the interatrial septum into a shaft lumen or cutter lumen.
The distal tissue retention system can include a retention shaft and a distal tissue retention device, with the actuator configured to change a relative position between the RF cutter and the distal tissue retention device to secure the interatrial septum between them. The invention further supports different distal retention device structures, including an expandable nitinol basket, and includes optional refinements such as a second electrode on the distal tissue retention device and actuator features that reduce a gap or lock a set distance between proximal and distal tissue retention devices.
Claims Coverage
The document includes three independent claims (clm-00001, clm-00014, clm-00022). Each independent claim centers on an RF cutter forming a 3 mm or larger durable aperture in an interatrial septum together with proximal and distal tissue retention devices whose relative position is changed by an actuator to secure the septum.
Rf cutter forming a 3 mm or larger durable interatrial aperture
An RF cutter on a distal end includes an electrode configured to cut a 3 mm or larger durable aperture in an interatrial septum.
Relative-position actuator for proximal and distal tissue retention devices
An actuator is configured to change a relative position between proximal and distal tissue retention devices.
Two-delivery-catheter arrangement with proximal and distal tissue retention
A medical device assembly comprising a first delivery catheter having the RF cutter and a proximal tissue retention device, and a second delivery catheter having a distal tissue retention device, with an actuator changing the relative position between the proximal and distal tissue retention devices.
Securing the interatrial septum between an rf cutter and distal retention device
A distal tissue retention system including a retention shaft and a distal tissue retention device, and an actuator configured to change a relative position between the RF cutter and the distal tissue retention device to secure the interatrial septum between them.
Retention and tenting of cut tissue and septum into lumens
The distal tissue retention device and/or a barb retains cut tissue between the RF cutter and the distal tissue retention device, including embodiments where cut tissue is retained in a cutter lumen and the barb tents a portion of the interatrial septum into the shaft lumen or the cutter lumen.
Distal tissue retention device as an expandable nitinol basket
The distal tissue retention device is an expandable nitinol basket.
Cavity with distal tissue retention device tenting the interatrial septum
One of the distal end, the RF cutter, or the proximal tissue retention device comprises a cavity, and the distal tissue retention device tents the interatrial septum into the cavity.
Force application at an outer circumference of a tissue retention device
The proximal tissue retention device and the distal tissue retention device apply a force at an outer circumference of one of the proximal tissue retention device or the distal tissue retention device.
Across the independent claims, the core inventive concept is combining an RF cutter electrode configured to cut a 3 mm or larger durable aperture in an interatrial septum with an actuator-driven relative positioning of proximal and distal tissue retention devices to secure the septum. Dependent refinements described in the claim set further specify retention and tenting behavior, optional second electrode structure, and distal retention device geometry such as an expandable nitinol basket.
Stated Advantages
Creates a 3 mm or larger durable aperture in an interatrial septum.
Secures the interatrial septum between tissue retention devices during cutting.
Retains cut tissue between the RF cutter and the distal tissue retention device.
Tents and positions a portion of the interatrial septum into a shaft lumen/cutter lumen or into a cavity.
Enables durable aperture formation using an RF cutter.
Documented Applications
Medical device assembly for cutting an interatrial septum to form a 3 mm or larger durable aperture.
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