Location, time, and/or pressure determining devices, systems, and methods for deployment of lesion-excluding heart implants for treatment of cardiac heart failure and other disease states
Inventors
Annest, Lon S. • Bertolero, Arthur A. • Swanson, David K.
Assignees
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Publication Number
US-11419723-B2
Publication Date
2022-08-23
Expiration Date
Abstract
Devices, systems, and methods for treating a heart of a patient may make use of structures which limit a size of a chamber of the heart, such as by deploying one or more tensile member to bring a wall of the heart and a septum of the heart into contact. A plurality of tension members may help exclude scar tissue and provide a more effective remaining ventricle chamber. The implant may be deployed during beating of the heart, often in a minimally invasive or less-invasive manner. Trauma to the tissues of the heart may be inhibited by selectively approximating tissues while a pressure within the heart is temporarily reduced. Three-dimensional implant locating devices and systems facilitate beneficial heart chamber volumetric shape remodeling.
Core Innovation
The invention provides a system for treating a heart with a chamber bordered by a first wall and a second wall. A perforation device penetrates the first wall and penetrates the second wall. An inflatable balloon is insertable through the first wall in a deflated state and is inflatable so that an axially oriented outer surface engages the first wall as the inflatable balloon is retracted proximally relative to the first wall.
The system also includes a first anchor engageable with the first wall and a second anchor engageable with the second wall. A tension member is coupleable with the inflatable balloon and the second anchor so that the tension member extends through the penetration in the first wall, across the chamber, through the penetration in the second wall, and to the second anchor. The inflatable balloon and the second anchor are tensionable via the tension member by an amount sufficient to engage the inflatable balloon with the first wall and to engage the second anchor with the second wall, thereby urging the first wall toward the second wall.
The inflatable balloon engages the first wall to seal the first wall and control blood loss through the penetration in the first wall. The first anchor and the second anchor are tensionable via the tension member to bring the first wall and the second wall into engagement, using the inflatable balloon and tensioned anchors to support controlled approximation of opposing heart walls.
Claims Coverage
The partial content includes two independent claims, a system claim and a method claim, centered on a tensioning mechanism using an inflatable balloon coupled to a tension member and anchors across a heart chamber. Across these independent claims, there are two primary inventive feature sets: a device arrangement that penetrates first and second walls and tensionably urges them into engagement, and a corresponding method of performing the wall penetration, balloon inflation and anchoring, and tensioning to urge wall engagement while sealing and controlling blood loss.
Tensionable inflatable balloon and anchors spanning a chamber for urging wall engagement
A system that penetrates first and second heart walls with a perforation device, uses an inflatable balloon insertable through the first wall and inflatable so an axially oriented outer surface engages the first wall during proximal retraction, couples a tension member with the inflatable balloon and a second anchor to extend across the chamber through penetrations to the second anchor, and tensions the inflatable balloon and the second anchor to urge the first wall toward the second wall while bringing the first wall and second wall into engagement.
Sealing via inflatable balloon while tensioning anchors to urge walls into engagement
A system wherein the inflatable balloon is engageable with the first wall to seal the first wall and control blood loss through the penetration in the first wall, and wherein the first anchor and the second anchor are tensionable via the tension member to bring the first wall and second wall into engagement.
Method of penetrating walls, positioning and inflating a balloon, anchoring, and tensioning to urge wall engagement
A method including penetrating the second wall with a perforation device, advancing the perforation device across the chamber to the first wall, penetrating the first wall, inserting the inflatable balloon through the second wall and the first wall in a deflated state with the inflatable balloon positioned distally of the first wall, inflating the inflatable balloon, engaging a first anchor with the first wall, engaging a second anchor with the second wall, and tensioning a tension member coupled with the inflatable balloon and the second anchor so the inflatable balloon is retracted proximally relative to the first wall to engage an axially oriented outer surface of the inflatable balloon with the first wall, wherein the inflatable balloon and second anchor are tensioned to urge the first wall toward the second wall and the first and second anchors are tensioned to bring the first wall and second wall into engagement.
The independent claims consistently require a heart-wall penetration arrangement using an inflatable balloon to engage and seal a first wall, coupled via a tension member to a second anchor to tensionably urge a first wall toward a second wall, and an anchoring and tensioning scheme that brings the first and second walls into engagement.
Stated Advantages
Seals the first wall and controls blood loss through the penetration in the first wall.
Documented Applications
Not explicitly described in patent.
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