Method and apparatus for closing off a portion of a heart ventricle

• US 10,022,226 B2
• Filed: 03/23/2015
• Issued: 07/17/2018
• Est. Priority Date: 06/09/2005
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Chin, Sing-Fatt, Annest, Lon S.
• Primary Examiner(s): MATTHEWS, CHRISTINE HOPKINS
• Application Number:
  US14/665,982
• Publication Number:
  US 20150196395A1
• Time in Patent Office: 1,212 Days
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61B 2017/22054 with two balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

Apparatus and methods to reduce ventricular volume are disclosed. The device takes the form of a transventricular anchor, which presses a portion of the ventricular wall inward, thereby reducing the available volume of the ventricle. The anchor is deployed using a curved introducer that may be inserted into one ventricle, through the septum and into the opposite ventricle. Barbs or protrusions along the anchor body combined with a mechanical stop and a sealing member hold the device in place once deployed.

Claims

1. A method of performing ventricular reconstruction of a heart, the method comprising:

passing an introducer from outside the heart through a wall of the heart;

passing the introducer through a septum of the heart;

inserting an anchor through the wall and through the septum of the heart, the anchor being coupled with a distal end of an elongate body that extends from the anchor through the wall and septum of the heart, wherein the anchor is inserted through the wall and septum ahead of an entire length of the elongate body;

extracting the introducer through the septum and the wall of the heart and removing the introducer to outside the heart;

subsequent to extracting the introducer through the septum and the wall of the heart, placing a sealing member over the elongate body, the sealing member being unconnected from the anchor and being slidable distally along the elongate body toward the anchor, wherein an interaction between the sealing member and the elongate body resists movement of the sealing member along the elongate body away from the anchor;

tensioning the elongate body to slide the sealing member distally along the elongate body and into engagement with the wall and to press the wall inward to engage the wall and the septum; and

securing the wall and septum via the interaction between the sealing member and the elongate body.

2. The method of claim 1, wherein securing the wall and septum reduces a volume of a left ventricle of the heart.

3. The method of claim 1, wherein the interaction between the sealing member and the elongate body comprises the sealing member engaging one or more protrusions extending from the elongate body.

4. The method of claim 1, wherein the sealing member comprises a resilient material adapted to resiliently press against an exterior surface of the wall of the heart.

5. The method of claim 1, further comprising removing a portion of a proximal end of the elongate body that extends proximally from the sealing member.

6. The method of claim 1, wherein the anchor is temporarily implanted.

7. The method of claim 1, further comprising deploying one or more arms of the anchor within a chamber of the heart, the one or more arms being engageable with the septum after deployment.

8. The method of claim 7, wherein the one or more arms are pivotally deployable from the elongate body.

9. The method of claim 1, wherein the introducer comprises a hollow bore and the step of inserting the anchor through the wall and through the septum of the heart comprises inserting the anchor through the hollow bore of the introducer.

10. A method of performing ventricular reconstruction of a heart, the method comprising:

passing an introducer from outside the heart through a wall of the heart;

passing the introducer through a septum of the heart;

inserting an anchor through the wall and through the septum of the heart, the anchor being coupled with a distal end of an elongate body that extends from the anchor through the wall and septum of the heart;

deploying one or more arms of the anchor within a chamber of the heart, the one or more arms being engageable with the septum after deployment;

extracting the introducer through the septum and the wall of the heart;

subsequent to extracting the introducer through the septum and the wall of the heart, placing a sealing member over the elongate body, the sealing member being slidable distally along the Elongate body and being configured to interact with the elongate body to resist movement of the sealing member along the elongate body away from the anchor;

tensioning the elongate body to engage the wall and the septum; and

securing the wall and septum via an interaction between the sealing member and the elongate body;

wherein the introducer comprises a hollow bore and wherein the anchor and an entire length of the elongate body are inserted through the hollow bore of the introducer to insert the anchor and elongate body through the wall and the septum of the heart.

11. The method of claim 10, wherein the interaction between the sealing member and the elongate body comprises engaging one or more protrusions extending from the elongate body.

12. The method of claim 10, wherein the sealing member comprises a resilient material adapted to resiliently press against an exterior surface of the wall of the heart.

13. The method of claim 10, further comprising removing a portion of a proximal end of the elongate body that extends proximally from the sealing member.

14. The method of claim 10, wherein the one or more arms are pivotally deployable from the anchor.

15. A method of performing ventricular reconstruction of a heart, the method comprising:

passing an introducer from outside the heart through a wall of the heart, the introducer comprising a proximal end and a distal end with a hollow bore extending between the proximal end and the distal end;

passing the introducer through a septum of the heart so that the introducer is positioned through the wall and the septum of the heart;

inserting an anchor and an elongate body axially through the hollow bore of the introducer and through the wall and septum of the heart, the anchor and elongate body being inserted through the hollow bore from the proximal end of the introducer to the distal end of the introducer and the anchor being coupled with a distal end of the elongate body such that the elongate body extends from the anchor through the wall and septum of the heart;

removing the introducer;

placing a sealing member over the elongate body, the sealing member being unconnected from the anchor and being slidable distally along the elongate body toward the anchor, wherein an interaction between the sealing member and the elongate body resists movement of the sealing member along the elongate body away from the anchor;

tensioning the elongate body to engage the wall and the septum; and

securing the wall and septum via the interaction between the sealing member and the elongate body.

16. The method of claim 15, wherein the interaction between the sealing member and the elongate body comprises engaging one or more protrusions extending from the elongate body.

17. The method of claim 15, wherein the sealing member comprises a resilient material adapted to resiliently press against an exterior surface of the wall of the heart.

18. The method of claim 15, further comprising removing a portion of a proximal end of the elongate body that extends proximally from the sealing member.

19. The method of claim 15, further comprising deploying one or more arms of the anchor within a chamber of the heart, the one or more arms being engageable with the septum after deployment.