Transcatheter device for interatrial anastomosis
Inventors
Arevalos, Christopher Alexander • GREIJDANUS, Albertien • KRIEGEL, Jacob • PATEL, Avni
Assignees
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Publication Number
US-12290305-B2
Publication Date
2025-05-06
Expiration Date
Abstract
The present disclosure relates to a device assembly and a method for treating heart failure by normalizing elevated blood pressure in the left atrium of a heart of a mammal Disclosed herein is a RF energy-based transcatheter interatrial septum excision device configured to create a sized interatrial aperture between the right and left atria of a heart for the relief of elevated left atrial pressure. The device assembly comprises a delivery catheter, a tissue stabilizer attached to a tissue stabilizer catheter, a tissue cutter attached to a tissue cutter catheter, a remotely located RF generator connected to an RF cathode and anode of the device assembly.
Core Innovation
The invention relates to RF energy-based transcatheter interatrial septum excision for heart failure, including forming a precisely sized interatrial aperture between the right atrium and the left atrium. The aperture is prescribed to relieve elevated left atrial pressure by creating interatrial communication with left-to-right shunting of at least 450%.
A device is disclosed that includes a first catheter defining a first lumen, where the first catheter includes a distalmost circumferential edge comprising first and second electrodes separated by a non-conductive portion. The electrodes are exposed within a recess of the distalmost edge, enabling RF energy delivery in relation to the excision site.
A second catheter is slidably received within the first lumen, carrying a tissue stabilizer configured to pull tissue into the first lumen. The tissue stabilizer and tissue cutter act together to create an excised tissue opening and then capture and retract the excised material, with a remotely located RF generator coupled to the electrodes.
Claims Coverage
The independent claims cover a two-catheter device with a first catheter having distalmost electrodes separated by a non-conductive portion and a second, slidable catheter carrying a tissue stabilizer that pulls tissue into the first lumen. Dependent claims further refine the electrode and edge structure and include RF generator coupling and defined RF operating ranges.
Distalmost circumferential electrode edge separated by non-conductive portion
A first catheter defining a first lumen, the first catheter comprising a distalmost circumferential edge comprising a first electrode, a second electrode, and a non-conductive portion separating the first electrode and the second electrode, wherein one or more of the first electrode and the second electrode are exposed within a recess of the distalmost edge.
Slidable tissue-stabilizer pull within the first lumen
A second catheter slidable within the first lumen, the second catheter comprising a tissue stabilizer configured to pull tissue into the first lumen.
Single distalmost edge electrode exposed in a recess
A first catheter defining a first lumen, the first catheter comprising a distalmost edge comprising a first electrode exposed within a recess of the distalmost edge.
Tissue stabilizer on the second catheter with electrode configured to pull tissue
A second catheter slidable within the first lumen, the second catheter comprising a tissue stabilizer comprising a second electrode, the tissue stabilizer configured to pull tissue into the first lumen.
RF generator coupled to the first and second electrodes
An RF generator coupled to both the first and second electrodes.
Defined RF signal frequency and power range
An RF generator configured to output an RF signal with a frequency between about 300 kHz and about 3 MHz and a power between about 1 W and about 500 W.
Across the independent claims, the inventive coverage is directed to the combination of a first catheter with distalmost electrode exposure, with non-conductive separation in one independent claim, and a second, slidable catheter including a tissue stabilizer that pulls tissue into the first lumen. Optional refinements disclosed in dependent claims include coupling an RF generator to the electrodes and defining an RF frequency and power operating range.
Stated Advantages
Relieves elevated left atrial pressure by creating a precisely sized interatrial aperture between right and left atria.
Provides interatrial communication with left-to-right shunting of at least 450%.
Results in acute formation of an approximately 8 mm aperture and confirmed patency at 30 days with no regrowth.
Documented Applications
RF energy-based transcatheter interatrial septum excision for heart failure, including relieving elevated left atrial pressure using a prescribed interatrial aperture and left-to-right shunting.
In vivo testing/documented studies include forming an interatrial aperture in male Yorkshire pigs, with fluoroscopy and intracardiac echocardiography (ICE) guidance and 30-day confirmed patency.
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