Systems, devices, and methods for forming an anastomosis

Inventors

Pate, Thomas D. • BERMAN, Zachary R.

Assignees

Alleviant Medical Inc

Abstract

Disclosed herein are systems, devices, and methods for treating heart failure. In some variations, a catheter for forming an anastomosis in a heart may comprise a first catheter comprising an electrode. A second catheter may be slidably disposed within the first catheter. The second catheter may comprise a barb and a dilator comprising a mating surface configured to engage the electrode.

Core Innovation

The invention relates to systems, devices, and methods for forming an interatrial anastomosis in a heart for treatment of heart failure, including congestive heart failure. The system includes an energy-based catheter arrangement configured to create an anastomotic opening in heart tissue between an interatrial location such as between the right atrium and the left atrium through the interatrial septum.

A first catheter includes an atraumatic electrode, and a second catheter is slidably disposed within the first catheter. The second catheter includes a barb and a dilator, where the barb includes a projection coupled to a base portion, with the projection spaced apart from the dilator by the base portion. Relative outer diameter relationships are used, including that a largest outer diameter of the barb is less than a largest outer diameter of the dilator, and a largest outer diameter of the base portion is less than a largest outer diameter of the barb.

In operation, the barb engages and stretches and/or punctures septum tissue to create controlled tissue tenting, while ablation is performed using the electrode to ablate compressed tissue to excise a controlled opening. The excised tissue is retained within the electrode lumen, and the system includes electrical behavior in which electrical shorting when the electrode contacts the dilator terminates plasma or energy generation. The description also includes open and closed configurations, controlled tenting by withdrawal, translation, or rotation of the barb, and sensing and visualization features such as fluoroscopy radiopaque markers, contrast agent or microbubble output via fluid ports, and ultrasound echogenic dilator regions.

The catheter system is described with structural and functional components including handle actuators, a signal generator providing waveforms including biphasic operation with a first higher-voltage and then a second lower-voltage portion, and a controller monitoring sensors. Imaging and sensing are supported by contrast agent delivery and echogenic ultrasound features, and the document references example interatrial anastomosis images in cadaver and porcine tissue.

Claims Coverage

Independent claim clm-00001 defines a heart anastomosis system with three inventive features: a first catheter with an atraumatic electrode, a second slidably disposed catheter with a barb and a dilator, and specified outer-diameter relationships among the barb projection, barb base portion, barb, and dilator.

The claim coverage is focused on the structural relationship between a first catheter with an atraumatic electrode and a second slidably disposed catheter that includes a barb and a dilator, together with specific outer-diameter constraints among the barb, barb base portion, and dilator to support forming a heart anastomosis.

Stated Advantages

Documented Applications