Signal Transmitting and Lesion Excluding Heart Implants for Pacing Defibrillating and/or Sensing of Heart Beat

• US 20080082132A1
• Filed: 09/28/2006
• Published: 04/03/2008
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: Baxano, Inc. (Baxano Surgical, Inc.), Bioventrix, Inc.
• Original Assignee: CHF Technologies Inc.
• Inventors: Bertolero, Arthur A., Swanson, David K., Annest, Lon S.
• Granted Patent: US 8,123,668 B2
• Time in Patent Office: Days
• US Class Current: 607/4
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3987 characterised by the timing or triggering of the shock

Abstract

Devices, systems, and methods for treating a heart of a patient may make use of structures which limit a size of a chamber of the heart, such as by deploying a tensile member to bring a wall of the heart toward (optionally into contact with) a septum of the heart. The implant may include an electrode or other structure for applying pacing signals to one or both ventricles of the heart, for defibrillating the heart, for sensing beating of the heart or the like. A wireless telemetry and control system may allowing the implant to treat congestive heart failure, monitor the results of the treatment, and apply appropriate electrical stimulation.

Claims

1. A method for treating a heart, the heart having a first chamber bordered by a septum and a wall, the heart having a second chamber separated from the first chamber by the septum, the method comprising:

deploying an implant into the septum and into the wall, the implant including a tensile member;

tensioning the tensile member between the septum and the wall to limit a dimension of the first chamber;

transmitting signals with the implant; and

pacing, defibrillating, and/or sensing characteristics of the heart using the transmitted signals.

2. The method of claim 1, further comprising transmitting the signals transceptally with the implant.

3. The method of claim 2, wherein the tensile member draws the wall and the septum into engagement.

4. The method of claim 3, wherein the chamber comprises a left ventricle of the heart, and wherein the wall and septum engage each other sufficiently to effectively exclude a portion of the wall and septum from the left ventricle, scar tissue extending along the excluded portion.

5. The method of claim 1 further comprising biventricular pacing of the left ventricle and a right ventricle using the implant, the implant comprising at least one lead extending from adjacent the tensile member to a contractile tissue.

6. The method of claim 1, further comprising sensing contractile heart tissue signals of the left ventricle and/or a right ventricle using the implant, the implant comprising at least one lead extending from adjacent the tensile member to a contractile tissue.

7. The method of claim 1, further comprising defibrillating the heart using the implant.

8. The method of claim 1, further comprising:

anchoring a first end of the tensile member to the septum with a first anchor; and

anchoring a second end of the tensile member to the wall with a second anchor.

9. The method of claim 8, wherein the anchoring of the first end of the tensile member to the septum is done so as to effectively seal the septum around transceptally transmitted signals.

10. The method of claim 8, further comprising transmitting the signals between the implant and the heart with an electrode surface of at least one of the anchors, wherein the signals comprise defibrillation signals.

11. The method of claim 10, wherein the implant extends through the wall, the second anchor engaging and applying the signals to an epicardial surface of the wall.

12. The method of claim 11, wherein the defibrillation signals are applied between the second anchor of the implant and a right atrium defibrillation lead.

13. The method of claim 8, further comprising applying the signals to the heart by pacing the heart with a lead of the implant, the lead being separated from the anchors.

14. The method of claim 8, further comprising sensing contraction using a lead of the implant, wherein the sensing comprises measuring heart contractile signals using the lead.

15. The method of claim 1, wherein the implant has a first mode and a second mode, the implant in the first mode wirelessly transmitting output signals indicating beating of the heart, the implant in the second mode pacing the heart or defibrillating the heart.

16. The method of claim 1, further comprising isolating transceptal signals from the septum with insulation extending along an axis of the tensile member.

17. An implant for treating a heart, the heart having a first chamber bordered by a septum and a wall, the heart having a second chamber separated from the first chamber by the septum, the implant comprising:

a first anchor coupleable to the septum;

a second anchor coupleable to the wall, separation between the second anchor and the first anchor constrainable so as to limit a dimension across the first chamber of the heart;

a pacing electrode, defibrillating electrode, and/or sensing surface; and

a signal transmission conductor near at least one of the anchors and coupled to the surface to allow heart signal transmission between the implant and a tissue of the heart.

18. The system of claim 17, wherein the surface comprises a pacing and/or beat sensing electrode surface, and further comprising insulation for isolating pacing and/or beat sensing signals from adjacent heart tissue.

19. The system of claim 18, further comprising a tensile member coupling the first anchor to the second anchor so as to limit a separation therebetween, and a conductor extending along at least a portion of the tensile member, the insulation disposed at least in part between the tensile member and conductor.

20. The system of claim 17, further comprising a tensile member coupling the first anchor to the second anchor so as to limit a separation therebetween, wherein the tensile member has a first configuration with a first anchor separation distance between the first anchor and the second anchor, and a second configuration with a second separation distance between the first anchor and the second anchor, the second separation distance being less than the first separation distance, the tensile member reconfigurable from the first configuration to the second configuration after the first and second anchors are deployed so as to exclude scar tissue from the first chamber.

21. The system of claim 17, further comprising an electrode surface along the second anchor.

22. The system of claim 21, further comprising a defibrillator signal source coupled with the electrode surface.

23. The system of claim 17, wherein the surface comprises a surface of a heartbeat sensing lead, the conductor included in the lead and the lead having a length sufficient to extend from adjacent one of the anchors to a contractile tissue when the implant is deployed, and further comprising a heartbeat monitoring signal processor coupled with the surface.

24. The system of claim 17, wherein the surface comprises a surface of a first pacing lead, the conductor included in the first lead and the first lead having a length sufficient to extend from adjacent one of the anchors to a contractile tissue when the implant is deployed, and further comprising:

a second pacing lead; and

a biventricular pacing signal source coupled with the first and second leads.

25. The system of claims 17, further comprising a signal source and/or signal processor wirelessly coupled with the electrode surface.

26. The system of claim 24, wherein the implant has a sensing mode and another mode, the implant in the sensing mode configured for transmitting output signals indicating beating of the heart to the processor, the implant in the other mode configured for pacing the heart or defibrillating the heart.

27. An implant for biventricular pacing of a heart, the heart having a first chamber having scar tissue and bordered by a septum and a wall, the heart having a second chamber separated from the first chamber by the septum, the implant comprising:

an elongate tensile member having an axis;

a first anchor coupleable with the tensile member to affix the tensile member to the septum;

a second anchor coupleable with the tensile member to affix the tensile member to the wall so that tensioning of the tensile member effectively excludes at least a portion of the scar tissue from the first chamber;

a first pacing electrode surface separated from the first anchor for positioning within the chamber beyond the scar tissue;

a second pacing electrode surface separated from the second anchor for positioning within the second chamber beyond the scar tissue; and

a biventricular pacing signal source coupled with the first and second electrode surfaces.

28. An implant for defibrillation of a heart, the heart having a first chamber bordered by a septum and a wall, the heart having a second chamber separated from the first chamber by the septum, the implant comprising:

an elongate tensile member having an axis;

a first anchor coupleable with the tensile member to affix the tensile member to the septum;

a second anchor coupleable with the tensile member to affix the tensile member to the wall so that tensioning of the tensile member limits a dimension of the first chamber;

an electrode surface disposed along the first anchor or the second anchor;

a defibrillation signal source coupled with the electrode surfaces.

29. The implant of claims 28, further comprising a signal processor coupled to the defibrillation signal source, wherein the processor has a sensing mode and another mode, the processor in the sensing mode configured for sensing signals indicating beating of the heart, the processor in the other mode configured for defibrillating the heart, the processor changing from the sensing mode to the other mode in response to the sensed heart beat signals.