Apparatus and methods to create and maintain an intra-atrial pressure relief opening
Inventors
CELERMAJER, David S. • McNamara, Edward I. • Sutherland, Michael W. • Sugimoto, Hiroatsu
Assignees
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Publication Number
US-11589854-B2
Publication Date
2023-02-28
Expiration Date
Abstract
The present disclosure relates to a method and a device for treating heart failure by normalizing elevated blood pressure in the left and right atria of a heart of a mammal. The present disclosure includes methods for creating and maintaining an opening in the atrial septum. Tools for making an opening and enlarging the opening are also disclosed. Use of the techniques and tools described herein prolongs the patency of an intra-atrial pressure relief opening.
Core Innovation
The invention relates to a system for normalizing elevated blood pressure in a heart chamber by creating an opening with a first small diameter in an atrial septum between a left atrium and a right atrium and enlarging the opening to a second larger diameter. The system includes a penetrator with a sharpened tip for penetrating the atrial septum and a dilation catheter having a conical distal tip and an elongated substantially tubular shaft, configured to be advanced over the penetrator such that the sharpened tip extends beyond the conical distal tip.
A treatment mechanism transfers heat energy to tissue surrounding the opening with the second larger diameter to ablate or otherwise damage the tissue. The treatment mechanism is positioned around a tubular shaft of the dilation catheter proximal to its conical distal tip, and is used to slow or prevent natural healing of the second larger diameter opening in the septum without implanting a stent or valve in the septum.
The disclosed forms include a thin wire electrode spiraling around the catheter shaft near the conical distal tip, radio frequency (RF) electrodes located on the surface of the dilation catheter shaft near the conical distal tip, multiple arrays of piezoelectric ultrasound transducers positioned around the circumference of the shaft near the conical distal tip, and a textured or ribbed cylindrical section for tissue interaction. The tissue-response objective is also expressed as abrading or scraping tissue surrounding the opening to promote thickened scar tissue formation.
Claims Coverage
The independent claim defines a system with three inventive features: a penetrator, a conical-tip dilation catheter advanced over the penetrator, and a treatment mechanism positioned around the dilation catheter shaft proximal to the conical distal tip. Dependent claims further refine the treatment mechanism and the tissue effect around the enlarged septal opening.
Penetrator and conical-tip dilation catheter advanced together
The system comprises a penetrator with a sharpened tip for penetrating an atrial septum between a left atrium and a right atrium by creating an opening with a first small diameter, and a dilation catheter for enlarging the opening to a second larger diameter, wherein the dilation catheter has a conical distal tip and an elongated substantially tubular shaft proximal to the distal tip and is configured to be advanced over the penetrator with the sharpened tip of the penetrator extending beyond the conical distal tip of the dilation catheter.
Heat transfer treatment mechanism positioned around the dilation catheter shaft proximal to the conical distal tip
A treatment mechanism for transferring heat energy to the tissue in order to ablate or otherwise damage the tissue surrounding the opening with the second larger diameter to slow or prevent natural healing of the second larger diameter opening in the septum without implanting a stent or valve in the septum, wherein the treatment mechanism is positioned around a tubular shaft of the dilation catheter proximal to its conical distal tip.
Spiraling thin-wire electrode near the conical distal tip
The treatment mechanism is made as a thin wire electrode spiraling around the catheter shaft near the conical distal tip.
RF electrodes on the dilation catheter shaft near the conical distal tip
The treatment mechanism includes radio frequency (RF) electrodes located on the surface of the dilation catheter shaft near its conical distal tip.
RF electrodes having two semi-circular shapes
The RF electrodes have two semi-circular shapes.
Piezoelectric ultrasound transducer arrays around the shaft circumference near the conical distal tip
The treatment mechanism is formed by multiple arrays of piezoelectric ultrasound transducers positioned around the circumference of the shaft of a dilation catheter near the conical distal tip.
Textured or ribbed cylindrical section for tissue interaction
The treatment mechanism includes a textured or ribbed cylindrical section for tissue interaction.
Abrading or scraping to promote thickened scar tissue formation
The treatment mechanism is configured to abrade or scrape tissue around an opening to promote thickened scar tissue formation.
The core coverage is the combination of a penetrator-created septal opening, a conical distal-tip dilation catheter advanced over the penetrator to enlarge the opening, and a treatment mechanism positioned around the shaft proximal to the conical distal tip to ablate or otherwise damage surrounding tissue and slow or prevent natural healing without implanting a stent or valve. Dependent claims further narrow the treatment mechanism form and the tissue response.
Stated Advantages
Slows or prevents natural healing of the second larger diameter opening in the septum.
Avoids implanting a stent or valve in the septum.
Documented Applications
No documented applications found
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