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

Bioventrix Inc

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 relates to determining a chamber treatment for a heart by defining an effective diameter for a cross section that corresponds to a pre-treated diameter and defining a desired diameter that is smaller than the effective diameter. The desired diameter corresponds to a desired volumetric shape of the chamber that is determined to provide an improved function of the chamber. A change in diameter is calculated from the effective and desired diameters, and a linear length of heart tissue to be excluded from the chamber at the cross section is calculated based on the calculated change in diameter.

The invention further includes deploying a first anchor and a second anchor at anchor locations within the chamber at the cross section. A tension member couples the first anchor with the second anchor, and the length of the tension member approximates the calculated linear length of heart tissue to be excluded. The tension member is tensioned to reduce the length of the tension member between the first anchor and the second anchor, thereby bringing opposing walls into apposition and reducing a volume of the chamber.

In related aspects, the invention determines the desired volumetric shape of the chamber using a modeling component configured to model a truncated prolate spheroid for a portion of the chamber. The truncated prolate spheroid can be modeled with a long axis that runs from a mitral valve of the heart to an apex of the chamber, and the first and second anchor locations can be determined based on the modeled truncated prolate spheroid.

Claims Coverage

Two independent claims are provided: one method claim and one system claim. Both claims share the same core inventive sequence of calculating a diameter change and tissue-exclusion length from an effective and desired diameter, then using coupled anchors and a tensionable member to bring opposing walls into apposition and reduce chamber volume. The coverage includes multiple dependent claim refinements, including truncated prolate spheroid modeling, anchor-pattern/template determination, anatomical landmark constraints, and a stated relationship for excluded tissue length.

The independent claims cover both a method and a system that compute effective and desired cross-sectional diameters, calculate a corresponding change in diameter and a linear length of heart tissue to be excluded, then deploy first and second anchors coupled by a tension member whose length approximates the excluded tissue length. Tensioning the member reduces chamber volume by bringing opposing walls into apposition, with dependent refinements specifying truncated prolate spheroid modeling, mitral valve-to-apex long-axis constraints, and a stated ΔC=Δd·π relationship.

Stated Advantages

Documented Applications

No documented applications found