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

• US 9,320,513 B2
• Filed: 03/13/2015
• Issued: 04/26/2016
• 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:
  US14/657,180
• Publication Number:
  US 20150282802A1
• Time in Patent Office: 410 Days
• Field of Search: 600/16
• US Class Current: 1/1
• 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 include devices, systems, and methods for reducing the distance between two locations in tissue. 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 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 system 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 system comprising:

a first elongate shaft having a proximal end and a distal end, the distal end of the first shaft being configured to be advanced from outside the patient into the heart along a first path so that the distal end of the first shaft is disposed in the first chamber;

a second elongate shaft having a proximal end and a distal end, the distal end of the second shaft being configured to be advanced along a second path from outside the heart, through the exterior wall and through the septum so that the distal end of the second shaft is disposed in the first chamber;

a first elongate flexible body slidably coupled to one of the shafts, the first flexible body having a distal end portion configured for in situ coupling, within the first chamber of the heart, with a corresponding distal end portion extending from the other of the shafts so as to join the first path with the second path;

an implant configured to be advanced along the joined paths, the implant including;

a first anchor having a low profile configuration for advancement of the first anchor along the joined paths;

a second anchor; and

an elongate tension member having a first end couplable with the first anchor and a second end coupleable with the second anchor, the first anchor configured to deploy laterally from the low-profile configuration within the first chamber, the tension member configured to extend from the first anchor in the first chamber, through the septum, through the second chamber, and through the exterior wall such that applying tension between the anchors with the tension member urges the septum and the external wall to engage.

2. The system of claim 1, wherein the first elongate flexible body is axially advanceable along the first shaft so that the end portion of the first elongate flexible body is disposed in the first chamber, and further comprising a second flexible body advanceable along the second shaft so that an end portion of the second flexible body is disposed in the first chamber, the end portion of the second flexible body comprising the corresponding end portion.

3. The system of claim 2, wherein the end portion of the first elongate flexible body has an opening configured for capturing the end portions of the second flexible body therein.

4. The system of claim 1, wherein the end portion of the first elongate flexible body comprises a snare, the snare biased to expand from a low profile configuration when released in the first chamber of the heart so as to expand the opening.

5. The system of claim 4, wherein the snare comprises a basket snare configured to expand by releasing the basket snare from a lumen of the first or second 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.

6. The system of claim 4, wherein the first or second shaft has a lumen, the snare configured to capture the corresponding end portion by withdrawing the snare into the lumen when the corresponding end portion extends through the lumen.

7. The system of claim 6, wherein the lumen extends along the second shaft, and wherein the corresponding end portion comprises a distal length of the tension member so that the tension member and first anchor are configured to be advanced to the first chamber along the first path by pulling the second end of the tension member with the first elongate flexible body through the septum and through the external wall.

8. The system of claim 6, wherein the corresponding end portion comprises a length of a guidewire, the guidewire having first and second opposed ends and configured so that the guidewire can extend from the first end portion outside the patient, into the first chamber along the first path, and through the septum, through the second chamber, through the external wall, and out of the patient to the opposed end along the second path.

9. The system of claim 1, wherein the second 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, the curved needle configured for forming the second path through the external wall and the septum.

10. The system of claim 1, further comprising an access tool configured for accessing the first chamber so as to define at least one of the first or second path, and a guide body advanceable from outside the patient to the first chamber along the access tool, the distal end of at least one of the first or second elongate bodies configured to be advanced to the first chamber using the guide body.

11. The system of claim 1, further comprising an axial force-application tool configured for applying a desired anchor migration inhibiting force between the anchors;

wherein the second anchor has a variable force mode configured to allow axial sliding of the anchor along the tension member toward the first anchor and away from the first anchor, wherein the second anchor has a set-force mode configured to inhibit sliding of the anchor away from the first anchor, and wherein the anchor is configured for changing from the variable-force mode to the set-force mode while the axial force-application tool applies the desired anchor force between the tension member and the second anchor.

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

13. The system of claim 1, wherein the first elongate shaft comprises an at least semi-rigid shaft and the distal end of the first elongate shaft comprises a tissue-penetrating tip configured to be advanced to the right ventricle through a right atrial appendage of the heart.

14. The system of claim 1, wherein the tension member and the first anchor are configured to be advanced into the first chamber of the heart along the first path with the tension member 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.

15. The system of claim 1, wherein the tension member and the first anchor are configured to be advanced into the heart along the second path with the tension member trailing from the advancing first anchor so as to extend through the second chamber when the first anchor reaches the first chamber.

16. A system for treating a heart within a patient, the heart having a chamber border by a plurality of walls, the system comprising

a first insertion device having a proximal end and a distal end, the distal end of the first insertion device being configured to be advanced from outside the patient into the heart along a first path so that the distal end of the first insertion device is disposed in the chamber;

a second insertion device having a proximal end and a distal end, the distal end of the second insertion device being configured to be advanced along a second path from outside the heart so that the distal end of the second insertion device is disposed in the chamber;

an elongate flexible body slidably coupled to one of the insertion devices, the elongate flexible body having a coupling member for in situ coupling, within the chamber of the heart, with a distal end portion extending from the other insertion device so as to join the first path with the second path;

an implant configured to be advanced along the joined paths, the implant including;

a first anchor having a low profile configuration for advancement of the first anchor along the joined paths;

a second anchor; and

an elongate tension member having a first end coupled with the first anchor and a second end coupleable with the second anchor, the first anchor configured to deploy laterally from the low-profile configuration within the chamber, the tension member configured to extend from the first anchor in the chamber and through a first wall of the heart such that applying tension between the anchors with the tension member urges the first wall to engage with a second wall of the heart.

17. The system of claim 16, wherein the elongate flexible body is axially advanceable along the first insertion device so that the end portion of the elongate flexible body is disposed in the chamber, and further comprising a guidewire that is advanceable along the second insertion device so that an end portion of the guidewire is disposed in the chamber, the end portion of the guidewire comprising the distal end portion that extends from the other distal end portion extending.

18. The system of claim 16, wherein the coupling member of the elongate flexible body comprises a snare, wherein the snare is biased to expand from a low profile configuration when released in the chamber of the heart.

19. The system of claim 18, wherein the first or second insertion device has a lumen, and wherein the snare is configured to capture the distal end portion that extends from the other insertion device by drawing the snare into the lumen.

20. The system of claim 19, wherein the lumen extends along the second insertion device, and wherein the distal end portion that extends from the other insertion device is a distal length of the tension member, wherein the tension member and first anchor are configured to be advanced to the chamber along the first path by pulling the second end of the tension member with the elongate flexible body through the first wall and second wall of the heart.

21. The system of claim 19, wherein the distal end portion that extends from the other insertion device is a length of a guidewire, the guidewire having first and second opposed ends and being configured so that the guidewire is extendable from outside the patient, into the chamber along the first path, through the first and second walls of the heart, and outside the patient along the second path.

22. The system of claim 16, wherein the second insertion device comprises a semi-rigid curved needle, the curved needle having a sharp tissue penetrating tip at the distal end and a lumen extending axially toward the distal end, the curved needle configured for forming the second path through the first wall of the heart.

23. The system of claim 16, further comprising an axial force-application tool configured for applying a desired anchor migration inhibiting force between the anchors;

wherein the second anchor has a variable force mode configured to allow axial sliding of the anchor along the tension member toward the first anchor and away from the first anchor, wherein the second anchor has a set-force mode configured to inhibit sliding of the anchor away from the first anchor, and wherein the anchor is configured for changing from the variable-force mode to the set-force mode while the axial force-application tool applies the desired anchor force between the tension member and the second anchor.