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

• US 10,179,049 B2
• Filed: 04/24/2017
• Issued: 01/15/2019
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Van Bladel, Kevin, Annest, Lon, Sheldon, Murray, Heflin, Ernie, Wechsler, Andrew, Stiggelbout, John, Arcia, Rovil, Bower, John
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/495,842
• Publication Number:
  US 20170224490A1
• Time in Patent Office: 631 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 treating a heart within a patient, the heart having a right ventricle and a left ventricle with a septum there between, the method comprising:

advancing a first catheter from a first position outside the patient, through the vasculature, and into the right ventricle so that a distal end of the first catheter is disposed in the right ventricle;

advancing a first member from the distal end of the first catheter so that the first member is positioned within the right ventricle;

advancing a needle from a second position outside the patient and penetrating tissue of an exterior wall of the left ventricle and tissue of the septum so that a distal end of the needle is disposed in the right ventricle;

advancing a second catheter from the second position outside the patient, through the penetration in the exterior wall of the left ventricle, and through the penetration in the septum so that a distal end of the second catheter is disposed in the right ventricle;

advancing a second member from the distal end of the second catheter so that the second member is positioned adjacent the first member;

coupling the first member and the second member to form a path from the first position outside the patient, through the vasculature, through the septum and exterior wall, and to the second position outside the patient;

advancing a first anchor and an elongate tension member into the right ventricle, via a delivery catheter, along the formed path so that the first anchor is positioned against the septum with the tension member extending from the first anchor, through the septum, through the left ventricle, and through the exterior wall with a distal end of the tension member disposed outside the heart;

coupling a second anchor to the tension member outside the heart;

advancing the second anchor, via an anchor engagement tool, into engagement with the exterior wall; and

applying tension between the first and second anchors via the tension member so that the first and second anchors urge the septum and the exterior wall toward one another.

2. The method of claim 1, wherein the first member is advanced from the distal end of the first catheter so that the first member is positioned adjacent a pulmonary artery of the heart.

3. The method of claim 2, wherein the first member is a snare device that is positioned adjacent the pulmonary artery, the snare device being configured to snare the second member adjacent or within the pulmonary artery.

4. The method of claim 3, wherein the second member is advanced from the distal end of the second catheter in a manner so that the second member flows with blood into the pulmonary artery.

5. The method of claim 4, wherein the second member includes a component that enables the second member to flow with blood into the pulmonary artery.

6. The method of claim 4, wherein the second member is a guidewire or a third catheter.

7. The method of claim 1, wherein the second member is a snare device that is positioned adjacent the pulmonary artery, the snare device being configured to snare the first member adjacent or within the pulmonary artery.

8. The method of claim 7, wherein the first member is a guidewire or a third catheter.

9. The method of claim 1, wherein coupling the first member and the second member together comprises pulling the second member through the first catheter so that a distal end of the second member is disposed at the first position outside the patient.

10. The method of claim 1, further comprising inhibiting migration of the first and second anchors by applying a desired anchor force between the tension member and the second anchor while the second anchor is slidably moveable along the tension member, the second anchor being reconfigurable to inhibit sliding movement of the second anchor along the tension member after the desired anchor force is applied.

11. The method of claim 1, wherein the first anchor and the tension member are advanced into the right ventricle while the heart is beating and with the first anchor axially aligned with the tension member in a low profile configuration, and wherein the first anchor is pivotable to a deployed configuration in which the first anchor is not axially aligned with the tension member.

12. The method of claim 1, wherein the delivery catheter is the first catheter.

13. A method for treating a heart within a patient comprising:

advancing a first elongate shaft from a first position outside the patient and into a right ventricle of the heart;

advancing a first member from the first elongate shaft to a position within the right ventricle;

advancing a second elongate shaft from a second position outside the patient and through a left ventricle wall and a septal wall so that a distal end of the second elongate shaft is disposed in the right ventricle;

advancing a second member from the second elongate shaft to the position adjacent the first member;

coupling the first member and the second member to form a path from the first position outside the patient, through the heart, and to the second position outside the patient;

advancing, via a delivery catheter, a first anchor and an elongate tension member into the right ventricle along the formed path so that the first anchor is positioned against the septal wall with the tension member extending from the first anchor and through the sepal wall and the left ventricle wall;

coupling a second anchor to the tension member;

advancing, via an anchor engagement tool, the second anchor into engagement with the left ventricle wall; and

applying tension between the first anchor and the second anchor via the tension member to urge the septal wall and left ventricle wall toward one another.

14. The method of claim 13, wherein the second elongate shaft is a needle that is configured to penetrate through the left ventricle wall and the septal wall.

15. The method of claim 13, wherein the second elongate shaft is a catheter that includes a tissue penetrating distal end that is configured to penetrate through the left ventricle wall and the septal wall.

16. The method of claim 13, wherein the first member is advanced from the first elongate shaft to a position adjacent a pulmonary artery of the heart.

17. The method of claim 16, wherein the first member is a snare device that is configured to snare the second member adjacent or within the pulmonary artery.

18. The method of claim 17, wherein the second member is a catheter.

19. The method of claim 17, wherein the second member is advanced from the distal end of the second elongate shaft in a manner so that the second member flows with blood into the pulmonary artery.

20. The method of claim 13, wherein the delivery catheter is the first elongate shaft.