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
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12303119-B2
Publication Date
2025-05-20
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 normalizing elevated blood pressure in a heart chamber by creating and maintaining an intra-atrial pressure relief opening in the atrial septum between a left atrium and a right atrium, including embodiments near the fossa ovalis. A penetrator with a sharpened tip creates an opening having a first diameter without implanting a stent or valve in the atrial septum, and a dilation catheter is advanced through the opening to form a second diameter opening.
A treatment mechanism transfers heat energy to tissue around the opening in order to ablate or otherwise damage tissue around the opening. The treatment mechanism is configured to slow or prevent natural healing of the second diameter opening so that patency persists, and tissue engagement is supported by a tissue grasper comprising a plurality of retaining prongs for engaging tissue.
The disclosed treatment mechanism includes energy-delivery options and tissue-engaging forms such as radio frequency electrodes, piezoelectric ultrasound transducer arrays, thermal conduction using heat-transfer fluid, and light or laser delivered via optical fibers, together with ablation, scraping, and thickened scar tissue effects. The framework also includes embodiments that treat septal tissue around the opening with chemical or drug coatings and embodiments that apply radiation energy. The overall objective is maintaining an intra-atrial pressure relief opening and reducing left atrial pressure by permitting blood flow from the left atrium to the right atrium through the opening.
Claims Coverage
The document provides two independent claims, covering a system and a method. The independent claims share inventive features focused on creating an intra-atrial pressure relief opening in the atrial septum without implanting a stent or valve, and using tissue treatment to slow or prevent natural healing in order to maintain patency.
Penetrator creating an atrial septum opening without stent or valve
A penetrator with a sharpened tip penetrates an atrial septum between a left atrium and a right atrium to create an opening having a first diameter, with treatment configured to slow or prevent natural healing of a second diameter opening without implanting a stent or valve in the atrial septum.
Dilation catheter advanced over the penetrator
A dilation catheter is configured to advance through the opening and has a conical distal tip and an elongated substantially tubular shaft proximal to the conical distal tip, wherein the dilation catheter is configured to be advanced over the penetrator.
Treatment mechanism transferring heat energy to slow or prevent healing and maintain patency
A treatment mechanism transfers heat energy to tissue around the opening to ablate or otherwise damage tissue around the opening, in order to slow or prevent natural healing of a second diameter opening larger than the first diameter in the atrial septum, without implanting a stent or valve in the atrial septum.
Tissue grasper with retaining prongs
A tissue grasper comprising a plurality of retaining prongs extends proximally and radially outwardly from the tissue grasper and is configured to engage tissue.
Method steps to form and maintain an intra-atrial pressure relief opening
The method penetrates an atrial septum between a right atrium and a left atrium to create an opening; inserts a dilator comprising a conical tip and an elongate body proximal to the conical tip through the opening; separates tissue around the opening to form an intra-atrial pressure relief opening; applies energy to the tissue to slow a natural healing process to maintain patency of the intra-atrial pressure relief opening without implanting a stent or valve; engages one or more prongs of a grasper with a plurality of retaining prongs; retracts the grasper into a sheath; and permits blood to flow from the left atrium to the right atrium through the intra-atrial pressure relief opening to reduce left atrial pressure.
Across the independent claims, the core coverage includes penetrating the atrial septum to create a relief opening, advancing a conical-tip dilation catheter, applying a treatment mechanism to ablate or otherwise damage tissue to slow or prevent natural healing and maintain patency, and using a grasper with retaining prongs, all without implanting a stent or valve. The method claim additionally requires permitting blood flow through the maintained intra-atrial pressure relief opening to reduce left atrial pressure.
Stated Advantages
Normalizing elevated blood pressure in a heart chamber.
Maintaining patency of the intra-atrial pressure relief opening.
Slowing or preventing natural healing of the larger-diameter opening.
Reducing left atrial pressure by permitting blood to flow from the left atrium to the right atrium through the intra-atrial pressure relief opening.
Avoiding implanting a stent or valve in the atrial septum/intra-atrial pressure relief opening.
Documented Applications
Treatment of heart failure involving elevated blood pressure by creating and maintaining an intra-atrial pressure relief opening in the atrial septum to normalize elevated blood pressure and reduce left atrial pressure.
Interested in licensing this patent?