Cardiac implant migration inhibiting systems

• US 9,173,711 B2
• Filed: 09/30/2012
• Issued: 11/03/2015
• Est. Priority Date: 09/30/2011
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Butler, William, Van Bladel, Kevin, Heflin, Ernie, Annest, Lon, Arcia, Rovil, Bower, John
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): KNAUSS, CHRISTIAN D
• Application Number:
  US13/632,106
• Publication Number:
  US 20130090672A1
• Time in Patent Office: 1,129 Days
• Field of Search: 600/16, 600/37, 606/151, 606/213, 606/214, 606/215, 606/232
• 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

Medical devices, systems, and methods reduce the distance between two locations in tissue, often for treatment of congestive heart failure. In one embodiment an anchor of an implant system may reside within the right ventricle in engagement with the ventricular 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 an epicardial surface. Deployment of the anchor within the right ventricle may be performed by inserting a guidewire through the septal wall into the right ventricle. The anchor may be inserted into the right ventricle over the guidewire and through a lumen of a catheter. An anchor force may be applied within a desired range to secure the anchors about the septum and epicardial surface. The anchor force may inhibit migration of the anchors relative to the septum and epicardial surface.

Claims

1. A method for inhibiting migration of anchors of a heart implant device adjacent walls of a heart within a patient body, the method comprising:

positioning a first anchor in engagement with a first wall of the heart, the first anchor being coupled with a tension member;

positioning a second anchor in engagement with a second wall of the heart, the second anchor being slidably coupled with the tension member so that the second anchor may slide proximally and distally along a length of the tension member;

applying an anchor force between the tension member and the second anchor by engaging the second anchor with a tension device, the anchor force being applied so that the first anchor provides a force urging the first wall toward the second wall and the second anchor provides a force urging the second wall toward the first wall, wherein the tension device comprises a shaft extending from a proximal end to a distal end, a lumen through which the tension member is inserted, and a tube that is slidably disposed over the shaft, the tube including a compression spring and indicia that provide an indication of the anchor force applied being within a desired range, and wherein the anchor force is applied by tensioning a portion of the tension member extending proximally of the tension device; and

securing the second anchor relative to the tension member while the anchor force is applied so as to restrict proximal movement of the second anchor along the tension member and maintain the anchor force.

2. The method of claim 1, wherein the second anchor comprises a variable force mode that allows the second anchor to slide proximally and distally along the tension member, and wherein the second anchor further comprises a set force mode that inhibits movement of the second anchor proximally along the tension member.

3. The method of claim 2, wherein the second anchor is reconfigured from outside the patient body.

4. The method of claim 2, wherein the second anchor comprises a lumen through which the tension member is inserted and a lock, and wherein the method further comprises operating the lock to reconfigure the second anchor from the variable force mode to the set force mode, or vice versa.

5. The method of claim 4, wherein the lock comprises a spring and a cam disposed adjacent the lumen or wherein the lock comprises a spring and lock plate disposed adjacent the lumen, and wherein operating the lock comprises biasing the lock plate or the cam against the tension member in the lumen.

6. The method of claim 4, wherein the lock is operated from outside the patient body.

7. The method of claim 1, wherein the first anchor is inserted distally of the first wall over a guidewire.

8. The method of claim 7, wherein the first anchor is inserted in a low profile configuration, and wherein the first anchor is deployable laterally relative to the tension member to a deployed configuration.

9. The method of claim 1, wherein the anchor force is sufficient to bring the first wall into engagement with the second wall, and is insufficient to induce passage of the first anchor through the first wall.

10. The method of claim 9, further comprising advancing an intermediate body of an ingrowth material along the tension member so that the intermediate body of ingrowth material is disposed between the first wall and the second wall before the walls are brought into engagement, extending the intermediate body of ingrowth material laterally from the tension member, and rotationally orienting the intermediate body of ingrowth material by rotating the tension member, the ingrowth material promoting tissue growth between the first and second wall.

11. The method of claim 1, wherein the anchor force comprises a force of between about 2N and about 6N.

12. The method of claim 1, wherein the anchor force comprises a force of between about 3N and about 4N.

13. The method of claim 12, wherein the tension device is configured such that the anchor force cannot exceed 4N.

14. The method of claim 1, wherein applying the anchor force comprises:

engaging the second anchor with the tension device in a first mode of operation to urge the first wall toward the second wall;

normalizing a force indicator of the tension device; and

applying a force to the second anchor with the tension device in a second mode of operation, wherein the tension device in the second mode of operation indicates the force applied to the second anchor.

15. The method of claim 1, wherein the first anchor and the second anchor are substantially the same size.

16. A method for inhibiting migration of anchors positioned adjacent walls of a chamber of a heart, the method comprising:

inserting a first anchor distally of a first wall of the heart, the first anchor being pivotally coupled with a tension member that extends from the first anchor, across the chamber of the heart, to proximally of a second wall of the heart;

positioning a second anchor proximally of the second wall, the second anchor being slidably coupled with the tension member in a variable force mode so that the second anchor slides proximally and distally along the tension member;

advancing the second anchor distally along the tension member via a tension device disposed outside the heart;

urging the first wall toward the second wall by engaging the second anchor with the tension device while the tension device is in a locked configuration;

normalizing a force indicator of the tension device;

adjusting the tension device to an unlocked configuration;

applying an anchor force to the second anchor with the tension device in the unlocked configuration, wherein the anchor force inhibits migration of the first and second anchors relative to the first wall and the second wall and wherein the tension device in the unlocked configuration indicates the anchor force via the force indicator; and

reconfiguring the second anchor from the variable force mode to a set force mode, the set force mode securing the second anchor relative to the tension member by inhibiting proximal movement of the second anchor along the tension member.

17. The method of claim 16, further comprising:

inserting the tension member through a lumen of the tension device; and

applying a tension force to a portion of the tension member extending proximally of the tension device.

18. A method for inhibiting migration of anchors of a heart implant device adjacent wall of a heart within a patient body, the method comprising:

positioning a first anchor in engagement with a first wall of the heart, the first anchor being coupled with a tension member;

positioning a second anchor in engagement with a second wall of the heart, the second anchor being slidably coupled with the tension member so that the second anchor may slide proximally and distally along length of the tension member;

engaging the second anchor with a tension device in a first mode of operation to urge the first wall toward the second wall;

normalizing a force indicator of the tension device;

applying an anchor force to the second anchor with the tension device in a second mode of operation so that the first anchor provides a force urging the firs wall toward the second wall and the second anchor provides a force urging the second wall toward the first wall, wherein the tension device in the second mode of operation indicates the anchor force that is applied to the second anchor; and

securing the second anchor relative to the tension member while the anchor force is applied so as to restrict proximal movement of the second anchor along the tension member and maintain the anchor force.

19. The method of claim 18, wherein the second anchor comprises a variable force mode that allows the second anchor to slide axially along the tension member, and wherein the second anchor further comprises a set force mode that inhibits proximal movement of the second anchor along the tension member.

20. The method of claim 19, wherein the second anchor comprises a lumen though which the tension member is inserted and a lock, and wherein the method further comprises operating the lock to reconfigure the second anchor from the variable force mode to the set force mode, or vice versa.

21. The method of claim 19, wherein the second anchor is reconfigured from outside the patient body.

22. The method of claim 18, wherein the first anchor is inserted over a guidewire.

23. The method of claim 22, wherein the first anchor is inserted in a low profile configuration, and wherein the first anchor is deployable laterally relative to the tension member to a deployed configuration.

24. The method of claim 18, wherein the tension device comprises a shaft extending from a proximal end to a distal end and a lumen through which the tension member is inserted, and wherein the anchor force is applied by tensioning a portion of the tension member extending proximally of the tension device.

25. The method of claim 24, wherein the tension device further comprises a tube slidably disposed over the shaft, the tube including a compression spring and indicia that provide an indication of the anchor force applied.

26. The method of claim 18, wherein the anchor force is sufficient to bring the first wall into engagement with the second wall, and is insufficient to induce passage of the first anchor through the first wall.

27. The method of claim 18, wherein the anchor force comprises a force of between about 2N and about 6N.

28. The method of claim 18, wherein the anchor force comprises a force of between about 3N and about 4N.

29. The method of claim 28, wherein the tension device is configured such that the anchor force cannot exceed 4N.

30. The method of claim 18, further comprising advancing an intermediate body of an ingrowth material along the tension member so that the intermediate body of an ingrowth material is disposed between the first wall and the second wall, extending the intermediate body of an ingrowth material laterally from the tension member, and rotationally orientating the intermediate body of an ingrowth material by rotating the tension member.