Over-the-wire cardiac implant delivery system for treatment of CHF and other conditions

• US 9,173,712 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: Annest, Lon, Sheldon, Murray, Van Bladel, Kevin, Heflin, Ernie, Butler, William, Wechsler, Andrew, Bower, John, Arcia, Rovil
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): KNAUSS, CHRISTIAN D
• Application Number:
  US13/632,108
• Publication Number:
  US 20130096579A1
• Time in Patent Office: 1,129 Days
• Field of Search: 606/190, 606/151, 606/213, 606/214, 606/215, 600/37
• 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 in a minimally invasive manner, often for treatment of congestive heart failure. In one embodiment, an anchor of an implant system may, when the implant system is fully deployed, 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 of the heart. 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 delivery catheter. Delivering the anchor over the guidewire may provide improved control in the delivery and placement of the anchor within the right ventricle.

Claims

1. A method for treating a heart of a patient comprising:

inserting a guidewire through a wall of the heart;

inserting a delivery catheter over the guidewire and into the heart, the delivery catheter comprising a first end, a second end, and a lumen extending between the first end and the second end through which the guidewire is inserted;

inserting an anchor over the guidewire via the delivery catheter to a position within a chamber of the heart, the anchor being coupled with a tension member and being operationally coupled with the guidewire so as to maintain the anchor in a low profile configuration with the anchor axially aligned with the delivery catheter as the anchor is inserted within the chamber;

deploying the anchor within the chamber by removing the guidewire to enable the anchor to reorient to a deployed configuration within the chamber of the heart; and

applying tension to the anchor via the tension member so as to urge the wall against a second wall of the heart.

2. The method of claim 1, wherein the anchor has a lumen extending along an axis of an elongate structure, and wherein inserting the anchor into the heart comprises advancing the anchor structure axially over the guidewire and into the chamber so that the guidewire inhibits injury to tissue structures along or within the chamber by the anchor.

3. The method of claim 1, further comprising inserting a dilating catheter through the wall prior to inserting the delivery catheter to dilate an aperture of the wall as the dilating catheter is inserted therethrough.

4. The method of claim 3, wherein the dilating catheter comprises a tapering threaded tip that contacts tissue of the wall, and wherein the method further comprises rotating the dilating catheter about a thread axis so that the tapering threaded tip dilates the aperture.

5. The method of claim 3, wherein the dilating catheter comprises a cutting element disposed toward a distal end of the dilating catheter that cuts tissue of the wall to dilate the aperture.

6. The method of claim 3, wherein the dilating catheter comprises a lumen extending between a first end and a second end, the dilating catheter being insertable over the guidewire through the wall along an arcuate path by inserting the guidewire through the lumen.

7. The method of claim 1, further comprising inserting a pusher tube through the lumen of the delivery catheter to push the anchor through the lumen of the delivery catheter.

8. The method of claim 7, wherein the pusher tube comprises a first lumen through which the tension member is inserted and a second lumen through which the guidewire is inserted.

9. The method of claim 8, wherein the anchor is pivotally coupled with the tension member and wherein the anchor comprises a first end, a second end, and a lumen extending between the first end to the second end, and wherein operationally coupling the guidewire with the anchor comprises inserting the guidewire through the lumen of the anchor to orient the anchor relative to the second lumen of the pusher tube as the anchor is inserted through the lumen of the delivery catheter.

10. The method of claim 9, further comprising withdrawing the guidewire from the lumen of the anchor after the anchor is positioned within the chamber so that the anchor pivots from a low profile configuration to a deployed configuration.

11. The method of claim 1, further comprising withdrawing the guidewire through a lumen of the anchor and the lumen of the delivery catheter after the anchor is positioned within the chamber such that the anchor is unlocked from a receptacle of the delivery catheter and able to pivot from a low profile configuration to a deployed configuration.

12. The method of claim 1, further comprising:

axially aligning the tension member with a guidance member;

coupling a proximal end of the guidance member with a distal end of the tension member; and

inserting the guidance member and tension member over the guidewire by inserting the guidewire through a lumen of a distal portion of the guidance member, the guidance member and tension member being advanced distally of the anchor.

13. The method of claim 1, further comprising:

positioning a second anchor adjacent the second wall; and

applying tension to the anchor and the second anchor so as to urge the wall against the second wall.

14. The method of claim 1, further comprising:

expanding a laterally deployable member of the delivery catheter adjacent the wall; and

engaging the laterally deployable member of the delivery catheter against the wall so as to urge the wall toward the second wall.

15. The method of claim 14, wherein the laterally deployable member comprises one or more selected from the group consisting of:

a balloon, a malecot, and a plurality of deployable arms.

16. A method for treating a heart of a patient, the heart comprising a chamber bordered by a wall, the method comprising:

inserting a guidewire into the chamber so that the inserted guidewire traverses the wall through an aperture in the wall;

inserting a dilating catheter over the guidewire to a position adjacent the wall, the dilating catheter comprising a tapering threaded tip having a thread axis;

rotating the dilating catheter about the thread axis as the dilating catheter is inserted through the wall so that the tapering threaded tip contacts tissue of the wall and rotational engagement between the tapering threaded tip and the tissue dilates the aperture of the wall to an expanded aperture;

inserting a delivery catheter over the guidewire and through the expanded aperture, the delivery catheter comprising a lumen through which the guidewire is inserted;

inserting an anchor over the guidewire and through the lumen of the delivery catheter, the anchor being coupled with a tension member and operationally coupled with the guidewire in a low profile configuration that enables insertion of the anchor through the expanded aperture;

reorienting the anchor within the chamber from the low profile configuration to a deployed configuration by removing the guidewire; and

applying tension to the anchor via the tension member.

17. The method of claim 16, further comprising:

applying tension to the anchor via the tension member so as to urge a septum wall of the heart against a chamber wall of the heart.

18. The method of claim 17, wherein the anchor and tension member are advanced adjacent the wall while the heart is beating and with the anchor axially affixed to the tension member in a low profile configuration, and wherein the anchor is deployed laterally relative to the tension member.

19. The method of claim 17, wherein the anchor is pivotally coupled with the tension member, and wherein the anchor comprises an elongate shaft having an axial lumen through which the guidewire is inserted, wherein the guidewire maintains an axial orientation of the anchor extending along the tension member while the anchor is advanced through the lumen of the delivery catheter.

20. The method of claim 17, further comprising:

coupling an additional anchor with the tension member;

positioning the additional anchor adjacent the chamber wall; and

applying tension to the anchor and additional anchor via the tension member so as to urge the septum wall against the chamber wall.

21. The method of claim 20, wherein the additional anchor comprises a variable force mode that allows the additional anchor to slide axially proximally and distally along the tension member and comprises a set force mode that inhibits either proximal or distal movement of the additional anchor along the tension member.

22. The method of claim 20, wherein applying tension to the anchor and additional anchor comprises applying a preselected amount of tension with a tension device, the tension device providing an indication of the amount of tension applied.

23. The method of claim 22, wherein applying a preselected amount of tension comprises applying a tension force between about 2 Newtons and about 6 Newtons.

24. The method of claim 22, wherein the tension device comprises a first end, a second end, and a lumen extending from the first end to the second end through which the tension member is inserted.

25. The method of claim 22, wherein applying a preselected amount of tension comprises applying a tension force between about 3 Newtons and about 4 Newtons.

26. The method of claim 25, wherein the tension device is further configured such that the applied tension force cannot exceed 4 Newtons.

27. A method for treating a heart of a patient, the heart comprising a chamber bordered by a septum, the method comprising:

inserting a guidewire into the chamber so that the inserted guidewire traverses a wall of the septum through an aperture in the septum wall;

inserting a dilating catheter over the guidewire to a position adjacent the septum wall, the dilating catheter comprising a tapering threaded distal tip having a thread axis;

rotating the dilating catheter about the thread axis as the dilating catheter is inserted through the septum wall so that the tapering threaded tip contacts tissue and rotational engagement between the tapering threaded tip and the tissue dilates the aperture of the septum wall to an expanded aperture;

inserting a delivery catheter through the expanded aperture of the septum wall;

inserting an anchor over the guidewire and through a lumen of the delivery catheter to a position distally of the septum wall, the anchor being coupled with a tension member and being operationally coupled with the guidewire in a low profile configuration that enables insertion of the anchor through the lumen of the delivery catheter, the anchor being deployable to a deployed configuration within the chamber upon removal of the guidewire; and

applying tension to the anchor via the tension member so as to urge the septum wall of the heart against a chamber wall of the heart.