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 9,211,115 B2
• Filed: 05/21/2007
• Issued: 12/15/2015
• Est. Priority Date: 09/28/2006
• 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 HOPKINS
• Application Number:
  US11/751,573
• Publication Number:
  US 20080294251A1
• Time in Patent Office: 3,130 Days
• Field of Search: 600/25, 600/37, 606/231
• US Class Current: 1/1
• 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 for applying suture clamps, clips or locks A61B2017/0488
• 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 diseased heart, the method comprising:

reducing, in a first cross-section, a first size of a chamber of a heart by decreasing a distance between a first anchor location and a second anchor location, the anchor locations disposed near edges of a diseased tissue bordering the chamber;

determining, for a second cross-section, a second reduction in size of the chamber, the second reduction in size being determined in response to;

an offset between the first cross-section and the second cross-section, and

a magnitude of the first reduction in cross-section of the chamber identified from a length of a catheter body extending between the first anchor location and the second anchor location; and

effecting the determined second reduction in size of the chamber by deploying third and fourth anchors into tissues of the heart bordering the chamber, and by reducing a length of a tension member under bias by a fixed preset force extending between the third and fourth anchors only while pressure within the chamber is less than systolic;

wherein the chamber in the first cross section has a first cross-section diameter defining a first curvature, wherein the catheter body has an axis between the first anchor and the second anchor, the axis having an axis curvature substantially corresponding to the first curvature, the magnitude of the first reduction in cross-section determined by measuring a length of the axis between the first anchor location and the second anchor location, and wherein decreasing the distance between the first anchor location and the second anchor location effects a change from the first cross-section diameter to a first reduced diameter.

2. The method of claim 1, wherein a magnitude of the second reduction in cross-section is identified from a length of a body extending between locations of the third anchor and the fourth anchor.

3. The method of claim 2, wherein the chamber in the second cross section has a second cross-section diameter defining a second curvature, wherein the body has a particular axis between the third anchor and the fourth anchor, the particular axis having an axis curvature substantially corresponding to the second curvature, the magnitude of the second reduction in cross-section determined by a length of the particular axis between the third anchor location and the fourth anchor location.

4. The method of claim 1, further comprising determining the second reduction in size in response to a diseased size of the chamber in the second cross section before the second reduction.

5. The method of claim 4, wherein the second reduction in size is determined by computing a change in length of a circumference of the second cross section from a desired change in diameter of the second cross section.

6. The method of claim 1, further comprising determining, for each of a plurality of cross-sections, an associated desired reduction in size of the chamber, the associated reduction in size being determined in response to:

a diseased size of the chamber in the cross-section before the associated reduction,

an offset between the first cross-section and the cross-section, and

a magnitude of the first reduction,

so as to define a desired volumetric shape of the chamber; and

effecting each determined reduction in size of the chamber by deploying associated anchors into tissues of the heart bordering the chamber, and by reducing a length of a tension member extending between the anchors to generate the desired volumetric shape of the chamber.

7. A method for treating a diseased heart, the method comprising:

deploying an anchor pattern template membrane against endocardial surfaces within a chamber of the heart by unrolling the anchor pattern template membrane from a deployment member, the anchor pattern template membrane identifying a plurality of anchor locations;

deploying a plurality of anchors into tissue of the heart per the aligned template membrane;

applying, between associated anchors of the plurality of anchors, tension so as to apply force to tissue adjacent the associated anchors and reduce an effective size of the chamber; and

removing the anchor pattern template membrane from the endocardial surfaces by rolling the anchor pattern template membrane to the deployment member.

8. The method of claim 7, further comprising inserting the anchor pattern template membrane into the chamber in a small-profile configuration and expanding the anchor pattern template membrane to a large-profile configuration within the chamber.

9. The method of claim 7, wherein the anchor pattern template membrane is aligned with scar tissue of the heart, and wherein the desired volumetric shape excludes the scar tissue from the chamber.