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

• US 10,617,525 B2
• Filed: 03/09/2018
• Issued: 04/14/2020
• Est. Priority Date: 05/21/2007
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Annest, Lon S., Bertolero, Arthur A., Swanson, David K.
• Primary Examiner(s): Matthews, Christine H
• Application Number:
  US15/917,466
• Publication Number:
  US 20180193148A1
• Time in Patent Office: 767 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/2481 Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/2484 Delivery devices therefor

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.

Claims

1. A method for treating a chamber of a heart comprising:

determining an effective diameter for a cross section of the chamber of the heart, the effective diameter corresponding to a pre-treated diameter of the chamber at the cross section;

determining a desired diameter for the cross section of the chamber, the desired diameter being smaller than the effective diameter and the desired diameter corresponding to a desired volumetric shape of the chamber that is determined to provide an improved function of the chamber;

calculating a change in diameter based on the effective diameter for the cross section and the desired diameter for the cross section;

calculating a linear length of heart tissue to be excluded from the chamber at the cross section based on the calculated change in diameter;

deploying a first anchor at a first anchor location within the chamber at the cross section;

deploying a second anchor at a second anchor location within the chamber at the cross section, wherein a tension member couples the first anchor with the second anchor and wherein a length of the tension member approximates the calculated linear length of heart tissue to exclude from the chamber; and

tensioning the tension member to reduce the length of the tension member between the first anchor and the second anchor and thereby bring opposing walls into apposition and reduce a volume of the chamber.

2. The method of claim 1, wherein the cross section of the chamber is a first cross section, and wherein the method further comprises calculating a change in a diameter of a second cross section of the chamber based on:

an offset between the first cross section and the second cross section of the chamber, and

a magnitude of the reduction in volume of the chamber at the first cross section.

3. The method of claim 2, further comprising:

deploying a third anchor at a third anchor location within the chamber at the second cross section;

deploying a fourth anchor at a fourth anchor location within the chamber at the second cross section, wherein a tension member couples the third anchor with the fourth anchor and wherein a length of the tension member approximates a calculated linear length of heart tissue to exclude from the chamber at the second cross section; and

tensioning the tension member to reduce the length of the tension member between the third anchor and the fourth anchor and thereby bring opposing walls into apposition at the second cross section and reduce a volume of the chamber.

4. The method of claim 1, wherein calculating the linear length of heart tissue to be excluded from the chamber comprises inserting a length of a body in the chamber between the first anchor location and the second anchor location.

5. The method of claim 4, wherein the chamber at the first cross section defines a first curvature, and wherein the body has an axis that extends between the first anchor location and the second anchor location, the axis having an axis curvature that substantially corresponds to the first curvature.

6. The method of claim 1, wherein calculating the linear length of heart tissue to be excluded from the chamber comprises inserting an anchor pattern template within the chamber that defines the first anchor location and the second anchor location.

7. The method of claim 1, wherein the linear length of heart tissue to be excluded from the chamber is calculated from the equation Δ

C=Δ

d·

π

, wherein Δ

C is the linear length of heart tissue to be excluded from the chamber and Δ

d is the change in diameter.

8. The method of claim 1, further comprising modeling a truncated prolate spheroid for a portion of the chamber to determine the desired volumetric shape of the chamber.

9. The method of claim 8, further comprising modeling the truncated prolate spheroid based on a long axis of the truncated prolate spheroid extending from a mitral valve of the heart to an apex of the chamber.

10. The method of claim 8, further comprising determining the first anchor location and the second anchor location based on the modeled truncated prolate spheroid.

11. A system for determining a treatment for a chamber of a heart, the system comprising:

a first anchor;

a second anchor;

a tension member that couples the first anchor with the second anchor;

a modeling component that is configured for;

determining an effective diameter for a cross section of the chamber, the effective diameter corresponding to a pre-treated diameter of the chamber at the cross section; and

determining a desired diameter for the cross section of the chamber, the desired diameter being smaller than the effective diameter and the desired diameter corresponding to a desired volumetric shape of the chamber that is determined to provide an improved function of the chamber; and

a processing component that is configured for;

calculating a change in diameter based on the effective diameter for the cross section and the desired diameter for the cross section; and

calculating a linear length of heart tissue to be excluded from the chamber at the cross section based on the calculated change in diameter;

wherein;

the first anchor is deployable at a first anchor location within the chamber at the cross section;

the second anchor is deployable at a second anchor location within the chamber at the cross section;

a length of the tension member between the first anchor and the second anchor approximates the calculated linear length of heart tissue to exclude from the chamber; and

the tension member is tensionable to reduce the length of the tension member between the first anchor and the second anchor and thereby bring opposing walls into apposition and reduce a volume of the chamber.

12. The system of claim 11, wherein the cross section of the chamber is a first cross section, and wherein the processing component is further configured for calculating a change in a diameter of a second cross section of the chamber based on:

an offset between the first cross section and the second cross section of the chamber, and

a magnitude of the reduction in volume of the chamber at the first cross section.

13. The system of claim 12, further comprising:

a third anchor;

a fourth anchor; and

a tension member that couples the third anchor with the fourth anchor;

wherein;

the third anchor is deployable at a third anchor location within the chamber at the second cross section;

the fourth anchor is deployable at a fourth anchor location within the chamber at the second cross section;

a length of the tension member between the third anchor and the fourth anchor approximates a calculated linear length of heart tissue to exclude from the chamber at the second cross section; and

the tension member is tensionable to reduce the length of the tension member between the third anchor and the fourth anchor and thereby bring opposing walls into apposition at the second cross section and reduce a volume of the chamber.

14. The system of claim 11, further comprising a body that is insertable within the chamber between the first anchor location and the second anchor location, the body being employable in calculating the linear length of heart tissue to be excluded from the chamber.

15. The system of claim 14, wherein the chamber at the first cross section defines a first curvature, and wherein the body has an axis that is extendable between the first anchor location and the second anchor location, the axis having an axis curvature that substantially corresponds to the first curvature.

16. The system of claim 11, further comprising an anchor pattern template that is insertable within the chamber to define the first anchor location and the second anchor location, the anchor pattern template being employable in calculating the linear length of heart tissue to be excluded from the chamber.

17. The system of claim 11, wherein the linear length of heart tissue to be excluded from the chamber is calculated from the equation Δ

C=Δ

d·

π

, wherein Δ

C is the linear length of heart tissue to be excluded from the chamber and Δ

d is the change in diameter.

18. The system of claim 11, wherein the modeling component is further configured for modeling a truncated prolate spheroid for a portion of the chamber to determine the desired volumetric shape of the chamber.

19. The system of claim 18, wherein the truncated prolate spheroid is modeled based on a long axis of the truncated prolate spheroid extending from a mitral valve of the heart to an apex of the chamber.

20. The system of claim 18, wherein the first anchor location and the second anchor location are determinable based on the modeled truncated prolate spheroid.