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

• US 8,979,750 B2
• Filed: 09/30/2012
• Issued: 03/17/2015
• 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:
  US13/632,104
• Publication Number:
  US 20130090684A1
• Time in Patent Office: 898 Days
• Field of Search: 600/16
• US Class Current: 600/213
• 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 first and second chambers with a septum therebetween, the second chamber having an exterior wall, the method comprising:

advancing a first elongate shaft from outside the patient into the heart along a first path so that a distal end of the first shaft is disposed in the first chamber;

advancing a second elongate shaft along a second path from outside the heart, through the exterior wall and through the septum so that a distal end of the second shaft is disposed in the first chamber;

joining the first path to the second path by coupling the distal end of the first shaft with the distal end of the second shaft within the first chamber of the heart;

advancing a first anchor and an elongate tension member into the heart along the joined paths, wherein the tension member is advanced into the first chamber and the tension member extends from the first anchor in the first chamber, through the septum, through the second chamber, and through the exterior wall with an end portion of the tension member being disposed outside the heart;

coupling a second anchor to the tension member end portion outside the heart; and

applying tension between the anchors with the tension member so that the anchors urge the septum and the external wall to engage.

2. The method of claim 1, wherein the first anchor and the tension member are advanced into the heart while the heart is beating and with the first anchor axially affixed to the tension member in a low profile configuration, and wherein the first anchor is deployed laterally relative to the tension member within the first chamber.

3. The method of claim 2, wherein the tension member and the first anchor are advanced into the first chamber of the heart along the first path, wherein the tension member is advanced from the first chamber along the second path by pulling an end of the tension member along the second path through the second chamber so that the end of the tension member extends outside the heart.

4. The method of claim 2, wherein the tension member and the first anchor are advanced into the heart along the second path, and wherein the tension member trails from the advancing first anchor so as to extend through the second chamber when the first anchor is advanced into the first chamber.

5. The method of claim 4, wherein a distal portion of the tension member and the first anchor are advanced within a dilating catheter having a dilating distal tip, and further comprising laterally releasing the anchor from the dilating catheter by retracting a sheath of the dilating catheter proximally from the dilating tip.

6. The method of claim 1, wherein the second elongate shaft comprises an at least semi-rigid curved needle, the curved needle having a sharp tissue penetrating tip at the distal end of the second shaft and a lumen extending axially toward the tip.

7. The method of claim 1, wherein the second shaft comprises a steerable catheter having a tissue penetrating tip.

8. The method of any of claims 1-7, further comprising advancing a first flexible body through the first elongate shaft so that an end portion of the first flexible body is disposed in the first chamber, and advancing a second flexible body through the second elongate shaft so that an end portion of the second flexible body is disposed in the first chamber, wherein the coupling of the distal end of the first elongate shaft with the distal end of the second elongate shaft comprises axially coupling the flexible bodies together within the first chamber of the heart.

9. The method of claim 8, wherein the axial coupling of the flexible bodies comprises capturing one of the end portions of one of the flexible bodies within an opening in the end portion of the other flexible body.

10. The method of claim 9, wherein the end portion of the other flexible body comprises a snare, and further comprising expanding the snare in the first chamber of the heart so as to expand the opening.

11. The method of claim 10, wherein the snare comprises a basket snare, and further comprising expanding the basket snare by releasing the basket snare from a lumen of the first elongate shaft so that the basket snare expands from a low profile insertion configuration to an expanded configuration encompassing a volume of the first chamber of the heart.

12. The method of claim 10, wherein the axial coupling of the flexible bodies further comprises shrinking the opening by withdrawing the opening into the first elongate shaft.

13. The method of claim 12, further comprising pulling the end portion of the second flexible body from the first chamber through the first elongate shaft and out of the patient, the second flexible body comprising a guidewire having an opposed end and the pulled guidewire extending from the end portion, into the first chamber, through the septum, through the second chamber, through the external wall, and out of the patient to the opposed end.

14. The method of claim 1, wherein the first anchor is advanced over a guidewire, wherein the first anchor comprising an elongate shaft having an axial lumen and is pivotably coupled to the tension member, the guidewire maintaining an axial orientation of the anchor extending along the tension member while the anchor is advanced axially into and within the first chamber of the heart.

15. The method of claim 1, further comprising accessing the first chamber so as to define at least one of the first or second path using an access tool, advancing a guide body from outside the patient to the first chamber using the access tool, and guiding the distal end of at least one of the first or second elongate bodies to the first chamber using the guide body.

16. The method of claim 1, further comprising orienting a working lumen of an epicardial hemostasis tool toward an epicardial surface region of the heart, the epicardial region encompassing the second path through the exterior wall, compressing the exterior wall of the heart inwardly around the second path with the hemostasis tool so as to inhibit bloodflow from the second chamber along the second path, and advancing the second anchor toward the epicardial region through the working lumen.

17. The method of claim 1, further comprising inhibiting migration of the anchors by applying a desired anchor force between the tension member and the second anchor while the second anchor is in a variable force mode, the second anchor in the variable force mode sliding axially proximally and distally along the tension member, and by reconfiguring the second anchor from the variable force mode to a set force mode while the desired anchor force is applied, the second anchor in the set force mode inhibiting movement of the second anchor along the tension member away from the first anchor.

18. The method of claim 17, wherein the desired anchor force is applied to the second anchor by engaging the second anchor, through a working lumen of a minimally invasive access tool, with a compression shaft, and wherein the second anchor is reconfigured from outside the patient body through the working lumen.

19. The method of claim 1, wherein the first elongate shaft comprises a flexible coronary catheter and the distal end of the first shaft is advanced to the right ventricle through the right atrium and blood vessels in fluid communication therewith.

20. The method of claim 1, wherein the first elongate shaft comprises a shaft and the distal end of the first elongate shaft is advanced to the right ventricle through a right atrial appendage of the heart.

21. A method for treating a heart within a patient having congestive heart failure, the heart having first and second chambers with a septum therebetween, the second chamber having an exterior wall, the method comprising:

advancing a first elongate shaft from outside the patient into the heart along a first path so that a distal end of the first shaft is disposed in the first chamber;

forming a second path by advancing a second elongate shaft from outside the heart, through the exterior wall and through the septum so that a distal end of the second shaft is disposed in the second chamber;

coupling the distal end of the first elongate shaft with the distal end of the second elongate shaft within the second chamber of the heart so as to join the first path to the second path;

advancing a tension member and a first anchor of an implant distally into the first chamber of the heart along the first path, wherein the tension member is advanced distally from the chamber by pulling a distal end of the tension member along the second path so that the tension member extends from the first anchor in the first chamber, through the septum, through the second chamber, and through the exterior wall to the distal end of the tension member outside the heart;

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

applying tension between the anchors with the tension member so that the septum engages the wall such that the congestive heart failure is mitigated.

22. A method for treating a heart within a patient having congestive heart failure, the heart having first and second chambers with a septum therebetween, the second chamber having an exterior wall, the method comprising:

advancing a first elongate shaft from outside the patient into the heart along a first path so that a distal end of the first shaft is disposed in the first chamber;

forming a second path by advancing a second elongate shaft from outside the heart, through the exterior wall and through the septum so that a distal end of the second shaft is disposed in the second chamber;

coupling the distal end of the first elongate shaft with the distal end of the second elongate shaft within the second chamber of the heart so as to join the first path to the second path;

advancing a first anchor distally into the first chamber of the heart along the second path and within the first chamber along the first path, wherein the tension member trails proximally from the anchor as the anchor is advanced distally so as to extend from the first anchor in the first chamber, through the septum, through the second chamber, and through the exterior wall to a proximal end of the tension member disposed outside the heart;

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

applying tension between the anchors with the tension member so that the septum engages the wall.