Treating dysfunctional cardiac tissue

• US 9,889,008 B2
• Filed: 11/02/2016
• Issued: 02/13/2018
• Est. Priority Date: 10/03/2007
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Annest, Lon S., Argento, Claudio, Butler, William, Heflin, Ernest
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/341,945
• Publication Number:
  US 20170156865A1
• Time in Patent Office: 468 Days
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/00469 for insertion of instruments, e.g. guide wire, optical fibre
• CPC Class Codes: A61B 2017/00561 creating a vacuum
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/0237 for heart surgery
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0408 Rivets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/0608 : J-shaped
• CPC Class Codes: A61B 2017/061 : hollow or tubular
• CPC Class Codes: A61B 2017/06176 : with protrusions, e.g. barbs
• CPC Class Codes: A61B 50/30 : Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61M 25/0138 : having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 : with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/09 : Guide wires
• 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 points in tissue, often for treatment of congestive heart failure and often in a minimally invasive manner. An anchor is inserted along an insertion path through a first wall of the heart. An arm of the anchor is deployed and rotationally positioned according to a desired alignment. Application of tension to the anchor may draw the first and second walls of the heart into contact along a desired contour so as to effect a desired change in the geometry of the heart. Additional anchors may be inserted and aligned with the first anchor to close off a portion of a ventricle such that the ventricle is geometrically remodeled and disease progression is reversed, halted, and/or slowed.

Claims

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

advancing a distal end of a catheter through a vena cavae and into a right atrium of the heart, the vena cavae being accessed via a femoral vein or an internal jugular vein;

advancing the distal end of the catheter through a tricuspid value and into a right ventricle of the heart;

positioning the distal end of the catheter adjacent a septum so that a distal tip of the catheter is positioned near dysfunctional tissue of the septum;

perforating the septum;

advancing, via the catheter, a guidewire across the septum through said perforation so that a distal end of the guidewire is positioned within a left ventricle of the heart;

advancing the catheter across the septum and across the left ventricle so that the distal end of the catheter is positioned adjacent to dysfunctional tissue on an anterior or lateral wall of the left ventricle;

perforating the dysfunctional tissue of the left ventricle;

advancing the distal end of the guidewire across the anterior or lateral wall of the left ventricle through said perforation so that the distal end of the guidewire is positioned external to the heart;

delivering a first anchor to a position adjacent the anterior or lateral wall of the left ventricle, the first anchor being positioned on an exterior surface of the anterior or lateral wall;

delivering, via the catheter, a second anchor to a position adjacent the septum by advancing the second anchor through the vena cavae, right atrium, and tricuspid valve, the second anchor being positioned within the right ventricle, wherein the first anchor and the second anchor are operably coupled with a tension member; and

tensioning the tension member to draw the first anchor and the second anchor toward one another and thereby draw the septum and anterior or lateral wall into engagement.

2. The method of claim 1, wherein the catheter is a first catheter and wherein the method further comprises inserting a second catheter through a lumen of the first catheter and positioning a distal tip of the second catheter adjacent the septum, the second catheter being configured to dilate the perforation through the septum to enable advancement of the first catheter and/or second catheter across the septum.

3. The method of claim 2, further comprising advancing the second catheter across the septum.

4. The method of claim 3, further comprising perforation the dysfunctional tissue of the left ventricle via the second catheter and advancing the second catheter across the anterior or lateral wall of the left ventricle.

5. The method of claim 1, wherein the first anchor and the second anchor are delivered through a lumen of the catheter to position said anchors adjacent said anterior or lateral wall and septum of the heart.

6. The method of claim 5, further comprising advancing the first anchor through the septum and the anterior wall to the position adjacent the anterior or lateral wall.

7. The method of claim 1, repeating the method steps to deliver additional anchors to the septum and the anterior or lateral wall of the heart, said additional anchors being positionable along a pre-selected apposition line relative to the heart.

8. The method of claim 1, wherein the first anchor and/or second anchor are advanceable in a low profile configuration and are deployable therefrom.

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

advancing a distal end of a catheter percutaneously through a vasculature and an atrium of the heart and into a first chamber of the heart;

positioning the distal end of the catheter adjacent a first wall of the heart so that a distal tip of the catheter is positioned near dysfunctional tissue of the first wall;

advancing the catheter across the first wall so that a distal end of the catheter is positioned within a second chamber of the heart;

advancing the distal end of the catheter across the second chamber so that the distal end of the catheter is positioned adjacent a second wall of the heart;

advancing the distal end of the catheter across the second wall of the heart so that the distal end of the catheter is positioned externally of the heart;

delivering, via the catheter, a first anchor to a position adjacent the second wall of the heart;

delivering, via the catheter, a second anchor to a position adjacent the first wall of the heart, wherein the first anchor and the second anchor are operably coupled with a tension member; and

tensioning the tension member to draw the first anchor and the second anchor toward one another and thereby draw the first wall and the second wall into engagement.

10. The method of claim 9, wherein the first anchor is positioned on an exterior surface of the second wall.

11. The method of claim 10, wherein the second anchor is positioned within the first chamber.

12. The method of claim 9, wherein the distal end of the catheter is advanced percutaneously through the atrium via an access in the femoral vein or the internal jugular vein.

13. The method of claim 9, wherein the catheter comprises a first catheter and a second catheter, the second catheter being insertable through a lumen of the first catheter.

14. The method of claim 13, further comprising advancing a distal end of the second catheter across the first wall of the heart and into the second chamber of the heart while the first catheter remain positioned proximally of the first wall.

15. The method of claim 14, further comprising advancing the distal end of the second catheter across the second wall of the heart so that the distal end of the second catheter is positioned external to the heart while the first catheter remain positioned proximally of the first wall.

16. The method of claim 9, wherein the first anchor and the second anchor are delivered through a lumen of the catheter to position said anchors adjacent said walls of the heart.

17. The method of claim 16, further comprising advancing the first anchor through the first wall and the second wall to the position adjacent the second wall.

18. The method of claim 9, repeating the method steps to deliver additional anchors to the first wall and the second wall of the heart, said additional anchors being positionable along a pre-selected apposition line relative to the heart.

19. The method of claim 9, wherein the first anchor and/or second anchor are advanceable in a low profile configuration and are deployable therefrom.

20. The method of claim 9, further comprising advancing a locking mechanism into the first chamber and against the second anchor, the locking mechanism being configured to secure the second anchor in position about the first wall of the heart.