Trans-catheter ventricular reconstruction structures, methods, and systems for treatment of congestive heart failure and other conditions

• US 9,662,212 B2
• Filed: 04/15/2016
• Issued: 05/30/2017
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Stiggelbout, John, Arcia, Rovil, Bower, John, Annest, Lon, Van Bladel, Kevin, Sheldon, Murray, Heflin, Ernie, Wechsler, Andrew
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/130,828
• Publication Number:
  US 20160338835A1
• Time in Patent Office: 410 Days
• Field of Search: 600 16
• CPC Class Codes: A61B 17/00 Surgical instruments, devices or methods, e.g. tourniquets A61B18/00 takes precedence; contraceptive devices, pessaries, or applicators therefor A61F6/00; eye surgery A61F9/007; ear surgery A61F11/00
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00323 Cables or rods
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/042 plastically deformed during insertion
• CPC Class Codes: A61B 2017/0422 by insertion of a separate member into the body of the anchor
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2017/22065 : Functions of balloons dilating A61M29/02
• CPC Class Codes: A61B 2017/2215 : having an open distal end
• CPC Class Codes: A61B 2017/306 : holding by means of suction
• CPC Class Codes: A61B 2017/3458 : threaded
• CPC Class Codes: A61B 2017/3488 : Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 34/70 : Manipulators specially adapted for use in surgery
• CPC Class Codes: A61B 5/0215 : by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Embodiments described herein include devices, systems, and methods for reducing the distance between two locations in tissue. In one embodiment, an anchor may reside within the right ventricle in engagement with the septum. A tension member may extend from that anchor through the septum and an exterior wall of the left ventricle to a second anchor disposed along a surface of the heart. Perforating the exterior wall and the septum from an epicardial approach can provide control over the reshaping of the ventricular chamber. Guiding deployment of the implant from along the epicardial access path and another access path into and through the right ventricle provides control over the movement of the anchor within the ventricle. The joined epicardial pathway and right atrial pathway allows the tension member to be advanced into the heart through the right atrium and pulled into engagement along the epicardial access path.

Claims

1. A method for delivering an anchor to a septal wall of a patient'"'"'s heart, the anchor being coupled at a proximal end of an elongate tension member and being pivotable between an insertion configuration and a deployed configuration, the method comprising:

inserting a catheter from outside a patient'"'"'s body into the heart so that a distal end of the catheter is disposed in a first chamber of the heart adjacent a proximal side of the septal wall;

inserting a distal end of the elongate tension member within a lumen of the catheter while the anchor is positioned proximally of and outside the patient'"'"'s body;

advancing the elongate tension member and the anchor through the lumen of the catheter with the elongate tension member advanced distally of the anchor and with the anchor in the insertion configuration, the elongate tension member being advanced through the lumen of the catheter so that the distal end of the elongate tension member is disposed within the first chamber;

advancing the distal end of the elongate tension member through a perforation in the septal wall and into a second chamber of the heart;

advancing the elongate tension member through the perforation in the septal wall until the anchor is positioned adjacent the proximal side of the septal wall;

pivoting the anchor from the insertion configuration to the deployed configuration; and

tensioning the elongate tension member to pull the anchor into contact with the proximal side of the septal wall.

2. The method of claim 1, wherein the distal end of the elongate tension member is coupled with a guidewire and wherein the elongate tension member is advanced through the lumen of the catheter and through the perforation in the septal wall along with the guidewire.

3. The method of claim 2, further comprising inserting the guidewire through a lumen of the anchor, wherein insertion of the guidewire through the lumen of the anchor facilitates in maintaining the anchor in the insertion configuration.

4. The method of claim 3, further comprising removing the guidewire from the lumen of the anchor to allow the anchor to pivot from the insertion configuration to the deployed configuration.

5. The method of claim 1, further comprising advancing the distal end of the elongate tension member through the patient'"'"'s body so that the distal end of the elongate tension member is disposed distally of and outside the patient'"'"'s body.

6. The method of claim 5, wherein the anchor is a first anchor and wherein the method further comprises:

attaching a second anchor to the distal end of the elongate tension member so that the second anchor is slidable proximally along the elongate tension member toward the first anchor, the second anchor having a release state in which the second anchor is slidable along the elongate tension member and a lock state in which the second anchor is secured about the elongate tension member;

sliding the second anchor proximally along the elongate tension member until the second anchor contacts an exterior wall of the heart, the second anchor being in the release state;

applying tension between the first anchor and the second anchor, via the elongate tension member, so as to tension the septal wall and the exterior wall; and

reconfiguring the second anchor to the lock state to secure the second anchor about the elongate tension member.

7. The method of claim 6, wherein the second anchor includes an elongate body that is aligned longitudinally with the elongate tension member as the second anchor is slid proximally along the elongate tension member.

8. A method for delivering an anchor to a wall of a heart of a patient, the anchor being coupled at a proximal end of an elongate tension member, the method comprising:

coupling a distal end of the elongate tension member with a guidewire, the guidewire having opposing ends that are positioned outside the patient'"'"'s body and an elongate section that traverses through the wall of the heart and through a chamber of the heart;

inserting the distal end of the elongate tension member within the patient'"'"'s body while the anchor is positioned outside of the body;

advancing the elongate tension member and the anchor through the patient'"'"'s body with the elongate member positioned distally of the anchor;

advancing the distal end of the elongate tension member through the wall of the heart;

advancing the elongate tension member through the wall until the anchor is positioned within the chamber of the heart adjacent the wall; and

tensioning the elongate tension member to pull the anchor into contact with the wall.

9. The method of claim 8, further comprising:

inserting a catheter from outside the body into the heart so that a distal end of the catheter is disposed in the chamber adjacent the wall;

inserting the distal end of the elongate tension member within a lumen of the catheter; and

advancing the elongate tension member and the anchor through the lumen of the catheter with the elongate tension member advanced distally of the anchor.

10. The method of claim 9, wherein the anchor is pivotable between an insertion configuration and a deployed configuration and wherein the anchor is advanced through the catheter'"'"'s lumen in the insertion configuration, and wherein the elongate member is pivoted to the deployed configuration when the anchor is positioned within the chamber.

11. The method of claim 10, further comprising inserting the guidewire through a lumen of the anchor to maintain the anchor in the insertion configuration.

12. The method of claim 11, further comprising removing the guidewire from the lumen of the anchor to allow the anchor to pivot from the insertion configuration to the deployed configuration.

13. The method of claim 8, further comprising advancing the distal end of the elongate tension member through the patient'"'"'s body so that the distal end of the elongate tension member is disposed distally of and outside the body while the anchor is positioned within the chamber.

14. The method of claim 8, wherein the anchor is a first anchor and wherein the method further comprises:

attaching a second anchor to the distal end of the elongate tension member;

sliding the second anchor proximally along the elongate tension member toward the first anchor until the second anchor contacts an exterior wall of the heart;

applying tension between the first anchor and the second anchor, via the elongate tension member, so as to tension the wall and the exterior wall of the heart; and

securing the second anchor about the elongate tension member.

15. A method for delivering an anchor to a wall of a heart of a patient, the anchor being coupled at a proximal end of an elongate tension member, the method comprising:

inserting a distal end of the elongate tension member within a patient'"'"'s body while the anchor is positioned outside of the patient'"'"'s body;

advancing the elongate tension member and the anchor through the patient'"'"'s body with the elongate tension member positioned distally of the anchor;

advancing the elongate tension member through the wall until the anchor is positioned within a chamber of the heart adjacent the wall; and

tensioning the elongate tension member to pull the anchor into contact with the wall.

16. The method of claim 15, further comprising coupling the distal end of the elongate tension member with a guidewire, the guidewire having opposing ends that are positioned outside the patient'"'"'s body and an elongate section that traverses through the wall and the chamber of the heart.

17. The method of claim 15, further comprising:

inserting a catheter from outside the body into the heart so that a distal end of the catheter is disposed in the chamber adjacent the wall;

inserting the distal end of the elongate tension member within a lumen of the catheter; and

advancing the elongate tension member and the anchor through the lumen of the catheter with the elongate tension member advanced distally of the anchor.

18. The method of claim 15, wherein the anchor is pivotable between an insertion configuration and a deployed configuration and wherein the anchor is advanced through the patient'"'"'s body in the insertion configuration, and wherein the anchor is pivoted to the deployed configuration when the anchor is positioned within the chamber.

19. The method of claim 18, wherein a guidewire is operably coupled with the anchor to maintain the anchor in the insertion configuration, and wherein the method further comprises uncoupling the guidewire from the anchor to allow the anchor to pivot from the insertion configuration to the deployed configuration.

20. The method of claim 15, wherein the anchor is a first anchor and wherein the method further comprises:

attaching a second anchor to the distal end of the elongate tension member;

sliding the second anchor proximally along the elongate tension member toward the first anchor until the second anchor contacts an exterior wall of the heart;

applying tension between the first anchor and the second anchor, via the elongate tension member, so as to tension the wall and the exterior wall of the heart; and

securing the second anchor about the elongate tension member.