Method and catheter for creating an interatrial aperture

Inventors

Vardi, Gil M.

Assignees

Intershunt Technologies Inc

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Publication Number

US-9814483-B2

Patent

Publication Date

2017-11-14

Expiration Date


Abstract

A catheter device with a cutting structure or means on the distal portion is disclosed, along with a medical procedure for using the device. The catheter 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 document describes a catheter-based medical device that creates a durable/permanent interatrial aperture between the right atrium and the left atrium by cutting an area of tissue in the interatrial septum. The system includes a catheter shaft with a central lumen and a distal catheter lumen, and a shaped blade arranged around the distal catheter lumen. The shaped blade is adapted to cut an area of tissue to create an aperture in tissue.

The device further includes a tissue articulator having a first position and a second position, configured to move with respect to the shaped blade. When the actuator connected to the tissue articulator is in the second position, the tissue articulator holds the tissue against the shaped blade for cutting. The described arrangement allows tissue to be held and tensioned during cutting, supporting formation of the interatrial aperture.

The document also describes tissue removal associated with the created aperture and additional catheter features for locating and imaging. Tissue removal mechanisms are described to remove cut tissue, and the catheter and/or sheath may include radiopaque and ultrasound markers to locate and track the system during fluoroscopy and echocardiography. The disclosure emphasizes aperture durability/permanent creation and provides a clinical rationale for reducing risks associated with temporary balloon approaches and certain permanent implant approaches.

Claims Coverage

The partial content contains two independent claims, centered on a catheter with a shaped cutting blade and a movable tissue articulator controlled by an actuator to hold tissue against the blade while an interatrial aperture is cut.

Catheter with shaped blade around distal lumen

A catheter shaft having a central lumen and a distal catheter lumen, and a shaped blade arranged around the distal catheter lumen, the blade adapted to cut an area of tissue to create an aperture in a tissue.

Movable tissue articulator holding tissue against shaped blade

A tissue articulator having a first position and a second position, configured to move with respect to the shaped blade, and adapted to hold the tissue against the shaped blade for cutting while in the second position.

Actuator controlling tissue articulator in second position

An actuator connected to the tissue articulator having a first position and a second position, wherein when the actuator is in the second position the tissue articulator holds the tissue against the shaped blade.

Method for treating congestive heart failure via interatrial septum aperture

Inserting a catheter into the right atrium, actuating the actuator to move the tissue articulator into a second position that holds the tissue against the shaped cutting blade, cutting an aperture in the interatrial septum between the right atrium and the left atrium, and removing a cut tissue from the right atrium.

Across the independent claims, the main inventive coverage is the coordinated catheter arrangement in which a shaped cutting blade cuts an interatrial septum aperture while a tissue articulator moved by an actuator holds tissue against the blade, followed by cutting and removal of cut tissue in the method for treating congestive heart failure.

Stated Advantages

Reduced risk of closure compared with temporary balloon approaches, as stated in the document.

Reduced risk of thrombosis and infection compared with approaches described in the document.

Avoidance of implanted devices and avoidance of anticoagulant therapy, as stated in the document.

Documented Applications

Treating congestive heart failure by creating an aperture in the interatrial septum between the right atrium and the left atrium using the described catheter device and method.

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