Leadless cardiac stimulation systems

• US 20060085042A1
• Filed: 03/07/2005
• Published: 04/20/2006
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Pikus, Michael J., Hastings, Roger N., Sadasiva, Anupama, Kveen, Graig
• Granted Patent: US 7,647,109 B2
• Time in Patent Office: Days
• US Class Current: 607/33
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• 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 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

Various configurations of systems that employ leadless electrodes to provide pacing therapy are provided. In one example, a system that provides multiple sites for pacing of myocardium of a heart includes wireless pacing electrode assemblies that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Also disclosed are various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Claims

1. A catheter delivery system for implantation of at least a portion of a wireless electrode assembly through endocardium tissue and into myocardium tissue, comprising:

a first elongate member having a proximal end and a distal end and defining a lumen passing therethrough;

a second elongate member having a proximal end and a distal end; and

a wireless electrode assembly attachable to the distal end of the second elongate member, wherein when the electrode assembly is attached to the second elongate member, the second elongate member is passable through the lumen to deliver at least a portion of the electrode assembly through the endocardium and into the myocardium.

2. The system of claim 1, wherein the electrode assembly includes an attachment mechanism having at least one fastener to penetrate through the endocardium and into the myocardium.

3. The system of claim 2, wherein the attachment mechanism is operable to secure at least a portion of the electrode assembly to the myocardium.

4. The system of claim 2, wherein the attachment mechanism includes at least one helical tine and at least one curled tine.

5. The system of claim 4, wherein the attachment mechanism includes a distally extending helical tine to penetrate through the endocardium and into the myocardium and a plurality of radially extending curled tines.

6. The system of claim 2, wherein the fastener of the attachment mechanism includes a tine, screw, barb, or hook.

7. The system of claim 1, wherein the second elongate member has a detachment mechanism at the distal end to release the electrode assembly from the second elongate member after delivery of the electrode assembly to the myocardium.

8. The system of claim 7, wherein the detachment mechanism includes a threaded member that releasably engages a portion of the electrode assembly.

9. The system of claim 7, wherein the detachment mechanism includes an adjustable locking member that releasably engages a portion of the electrode assembly.

10. The system of claim 1, wherein the first elongate member includes a steering mechanism to direct the distal end of the first elongate member to a selected site proximate to the endocardium.

11. The system of claim 10, wherein the first elongate member includes an electrode at its distal end for sensing a local electrocardiogram at the selected site proximate to the endocardium.

12. The system of claim 1, further comprising an access catheter having a proximal end and a distal end and having a lumen passing therethrough, wherein the first elongate member is a delivery catheter that is passable through the lumen of the access catheter.

13. The system of claim 12, further comprising an image device near the distal end of the access catheter.

14. The system of claim 13, wherein the image device includes an ultrasonic device to provide visualization of a selected site distal of the access catheter.

15. An implantable wireless electrode assembly comprising:

a first electrode to discharge a pacing electrical pulse; and

an attachment mechanism having at least one fastener to penetrate through endocardium tissue and into myocardium tissue, at least a portion of the attachment mechanism being disposed proximate to the electrode such that, when the fastener penetrates through the endocardium and into the myocardium, the electrode is positioned proximate to the myocardium.

16. The wireless electrode assembly of claim 15, further comprising a second electrode spaced apart from the first electrode such that, when the fastener penetrates through endocardium and into the myocardium, the first electrode is positioned proximate to the myocardium while the second electrode is exposed to blood in an internal heart chamber.

17. The wireless electrode assembly of claim 15, further comprising an induction device to receive electromagnetic energy from an external source, wherein the first electrode is electrically connected to a circuit such that the pacing electrical pulse is generated from at least a portion of the electromagnetic energy received by the induction device.

18. The wireless electrode assembly of claim 15, wherein the circuit includes an energy storage element to store the electromagnetic energy received by the induction device, the energy storage element being operable to periodically discharge electrical energy to the electrode.

19. The wireless electrode assembly of claim 15, wherein the induction device includes a coil that is inductively coupled to the external source.

20. The wireless electrode assembly of claim 15, wherein the attachment mechanism includes at least one helical tine and at least one curled tine.

21. The wireless electrode assembly of claim 20, wherein the attachment mechanism includes a distally extending helical tine to penetrate through the endocardium and into the myocardium and includes a plurality of radially extending tines that are adapted to a curl into the endocardium or myocardium after the helical tine penetrates into the myocardium.

22. The wireless electrode assembly of claim 15, wherein the fastener of the attachment mechanism includes a tine, screw, barb, or hook.

23. The wireless electrode assembly of claim 15, further comprising a detachment mechanism spaced apart from the fastener of the attachment mechanism, the detachment mechanism including a threaded member and being operable to release the wireless electrode assembly from a delivery system after the fastener penetrates through endocardium and into the myocardium.

24. A method of delivering a wireless electrode assembly into an internal heart chamber and proximate the myocardium, the method comprising:

directing a distal end of a first elongate member into an internal heart chamber, the first elongate member having the distal end and a proximal end and having a lumen passing therethrough;

directing a wireless electrode assembly through the lumen of the first elongate member toward the distal end of the first elongate member; and

penetrating at least a portion of the wireless electrode assembly through endocardium tissue and into the myocardium.

25. The method of claim 24, wherein the wireless electrode assembly is attached to a distal end of a second elongate member that is passable through the lumen of the first elongate member, the method further comprising operating a detachment mechanism to release the wireless electrode assembly from the first elongate member.

26. The method of claim 25, further comprising withdrawing the second elongate member and the first elongate member away from endocardium.

27. The method of claim 24, further comprising measuring a local electrocardiogram with a sensor at the distal end of the first elongate member after at least a portion of the wireless electrode assembly penetrates the endocardium.

28. The method of claim 27, further comprising deploying one or more adjustable tines of the wireless electrode assembly after measuring the local electrocardiogram.

29. The method of claim 27, further comprising withdrawing the wireless electrode assembly from the myocardium after measuring the local electrocardiogram and penetrating at least a portion of the wireless electrode assembly through a different portion the endocardium and into a different portion of the myocardium.

30. The method of claim 24, wherein penetrating at least a portion of the wireless electrode assembly through endocardium tissue and into the myocardium comprises causing an attachment mechanism of the electrode assembly to penetrate through the endocardium.