Signal transmitting and lesion excluding heart implants for pacing, defibrillating, and/or sensing of heart beat

• US 9,039,594 B2
• Filed: 01/28/2014
• Issued: 05/26/2015
• Est. Priority Date: 09/28/2006
• Status: Active Grant

• Current Assignee: Bioventrix, Inc.
• Original Assignee: Bioventrix, Inc.
• Inventors: Annest, Lon S., Bertolero, Arthur A., Swanson, David K.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US14/166,765
• Publication Number:
  US 20140330296A1
• Time in Patent Office: 483 Days
• Field of Search: 600 16- 18, 607/2, 607 4- 6, 607/9
• US Class Current: 600/16
• 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 a first anchor adjacent the septum so that the first anchor engages tissue of the septum;

deploying a second anchor adjacent the wall so that the second anchor contacts and engages an epicardial surface of the wall;

tensioning a tensile member that is coupled with the first anchor and the second anchor to draw the wall into contact with the septum and to secure the wall relative thereto;

positioning an electrode member adjacent the epicardial surface of the wall, the electrode member being coupled with a signal processor and/or signal generator;

transmitting signals from the epicardial surface of the wall to the signal processor and/or signal generator with the electrode member; and

pacing, defibrillating, and/or sensing characteristics of the heart via the signal processor and/or signal generator using the transmitted signals.

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

3. The method of claim 1, wherein the first 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.

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

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

6. The method of claim 1, further comprising defibrillating the heart using the transmitted signals.

7. The method of claim 1, wherein the first anchor is disposed through the septum so as to effectively seal the septum around transceptally transmitted signals.

8. The method of claim 1, wherein the electrode member is an electrode surface of at least one of the anchors, and wherein the method further comprises transmitting defibrillation signals from the signal processor and/or signal generator to the electrode member.

9. The method of claim 8, wherein the defibrillation signals are applied between the second anchor and a right atrium defibrillation lead that is coupled with the signal processor and/or signal generator.

10. The method of claim 1, wherein the electrode member comprises a pacing electrode, defibrillating electrode, and/or sensing surface.

11. The method of claim 1, further comprising applying pacing signals to the heart by pacing the heart with a lead that is coupled with the signal processor and/or signal generator and separated from the anchors.

12. The method of claim 1, further comprising sensing contraction using a lead coupled with the signal processor and/or signal generator, wherein the sensing comprises measuring heart contractile signals using the lead.

13. The method of claim 1, wherein the signal processor and/or signal generator comprises a first mode and a second mode, and wherein the method further comprises:

in the first mode, wirelessly transmitting output signals from the signal processor and/or signal generator to an external processor indicating beating of the heart, and

in the second mode, pacing or defibrillating the heart via the signal processor and/or signal generator.

14. The method of claim 1, wherein the signals are transmitted transceptally along an axis of the tensile member and wherein the method further comprises isolating the transceptal signals from the septum via insulation extending along an axis of the tensile member.

15. 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 so that the second anchor contacts an epicardial surface of the wall;

a tensile member coupleable to the first anchor and the second anchor and tensionable to engage the septum and the wall and to secure the septum relative thereto;

an electrode member positioniable adjacent the epicardial surface of the wall and configured to apply signals to the epicardial surface of the wall; and

a signal generator coupled with the electrode member, the signal generator being configured to generate the signals applied to the epicardial surface of the wall.

16. The implant of claim 15, wherein the tensile member includes insulation extending along an axis of the tensile member for isolating pacing and/or beat sensing signals from the epicardial surface.

17. The implant of claim 16, further comprising 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.

18. The implant of claim 15, wherein the electrode member is coupled with the second anchor.

19. The implant of claim 15, wherein the electrode member is a pacing electrode, defibrillating electrode, and/or sensing surface.

20. The implant of claim 15, wherein the electrode member comprises a surface of a heartbeat sensing lead, 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 heartbeat sensing lead.

21. The implant of claim 15, further comprising:

a pacing lead; and

a biventricular pacing signal source coupled with the pacing lead.

22. The implant of claim 21, wherein the signal generator comprises a monitoring mode and a stimulating mode, wherein in the monitoring mode the signal generator is configured for transmitting output signals indicating beating of the heart, and wherein in the stimulating mode the signal generator is configured for pacing the heart or defibrillating the heart.