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 9,913,719 B2
• Filed: 12/14/2015
• Issued: 03/13/2018
• 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:
  US14/968,637
• Publication Number:
  US 20160206427A1
• Time in Patent Office: 820 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 system for treating a diseased heart comprising:

a first implant set including a first anchor for coupling to a first location bordering a chamber of the heart, a second anchor for coupling to a second location bordering the chamber of the heart, and a first tension member for coupling the first anchor with the second anchor, the second anchor being slidable distally along the first tension member toward the second location, the first implant set suitable for reducing, in a first cross-section, a first size of the chamber of the heart by displacement of the first anchor location toward the second anchor location;

a second implant set including a third anchor for coupling to a third location bordering the chamber of the heart, a fourth anchor for coupling to a fourth location bordering the chamber of the heart, and a second tension member for coupling the third anchor with the fourth anchor, the fourth anchor being slidable distally along the second tension member toward the fourth location, the second implant set suitable for reducing, in a second cross-section, a second size of the chamber of the heart by displacement of the third anchor location toward the fourth anchor location; and

an anchor placement member that is positionable about the first tension member and the second tension member and slidable there along to enable the anchor placement member to contact an anchor lock of the second anchor and the fourth anchor and apply a tension force to the second anchor and the fourth anchor in order to displace the first anchor location toward the second anchor location and displace the third anchor location toward the fourth anchor location, the anchor placement member being removable from the anchor lock of the second anchor and the fourth anchor after the tension force is applied to the second anchor and the fourth anchor, wherein the anchor lock of the second anchor and the fourth anchor affixes the second anchor and the fourth anchor to the first tension member and the second tension member, respectively.

2. The system of claim 1, wherein the system includes a biasing structure that is configured to apply a preset tension force to the second anchor or the fourth anchor.

3. The system of claim 1, wherein, for the second cross-section, the 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.

4. A device for treating a diseased heart, the device for use with a plurality of anchors, the device comprising:

an anchor pattern template for aligning with a chamber of the heart, the anchor pattern template being insertable in a collapsed state through a wall of the heart into the chamber of the heart, the anchor pattern template being radially expandable from the collapsed state within the chamber of the heart such that the anchor pattern template is positioned against the inner surface of the wall in alignment with infarcted scar tissue of the heart, the anchor pattern template comprising indicia identifying a plurality of anchor locations such that when the anchor pattern template is radially expanded within the chamber, the plurality of anchors are deployable into tissue of the heart per the aligned indicia, and tension is applied between deployed anchors so as to approximate the tissue, an effective size of the chamber is reduced, the anchor pattern template being removable in the collapsed state from the chamber of the heart;

wherein in the collapsed state, the anchor pattern template is rolled around an axis of a template catheter.

5. The device of claim 4, wherein the indicia are visible under direct imaging.

6. The device of claim 4, wherein when the plurality of anchors are deployed per the indicia and the tissue is approximated, a desired volumetric shape of the chamber is generated, the desired shape excluding the scar tissue from the chamber.

7. The device of claim 4, wherein the anchor pattern template is radially expanded by unrolling the anchor pattern template from the collapsed state within the chamber of the heart.