Leadless Cardiac Stimulation Systems

• US 20080109054A1
• Filed: 05/07/2007
• Published: 05/08/2008
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Scimed Life Systems Incorporated (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 8,340,780 B2
• Time in Patent Office: Days
• US Class Current: 607/127
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/059 Anchoring means
• CPC Class Codes: A61N 1/362 Heart stimulators heart defibrillators A61N1/39
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37512 Pacemakers
• 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. 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.

2. The wireless electrode assembly of claim 1, 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.

3. The wireless electrode assembly of claim 1, 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.

4. The wireless electrode assembly of claim 1, 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.

5. The wireless electrode assembly of claim 1, wherein the induction device includes a coil that is inductively coupled to the external source.

6. The wireless electrode assembly of claim 1, wherein the attachment mechanism includes at least one helical tine and at least one curled tine.

7. The wireless electrode assembly of claim 6, 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.

8. The wireless electrode assembly of claim 1, wherein the fastener of the attachment mechanism includes a tine, screw, barb, or hook.

9. The wireless electrode assembly of claim 1, 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.

11. The wireless electrode assembly of claim 1, wherein, when the fastener penetrates through the interior surface of the heart chamber and into the myocardial wall, the first electrode is positioned is the myocardial wall while the second electrode is exposed to an interior of the heart chamber.

10. An implantable wireless electrode assembly comprising:

first and second electrodes to provide a pacing electrical pulse to heart tissue, the second electrode being spaced apart from the first electrode;

an induction coil to wirelessly receive electromagnetic energy from an external source, wherein the first and second electrodes are directly activated by the induction coil via an internal, battery-free circuit such that the pacing electrical pulse is generated from at least a portion of the electromagnetic energy received by the induction device; and

at least one fastener to penetrate through an interior surface of a heart chamber and into a myocardial wall, wherein at least one of the first and second electrodes is positioned in the myocardial wall when the fastener penetrates through the interior surface of the heart chamber and into the myocardial wall.

12. The wireless electrode assembly of claim 10, wherein the fastener is selected from the group consisting of a tine, a screw, a barb, and a hook.

13. The wireless electrode assembly of claim 10, further comprising a detachment mechanism to release the wireless electrode assembly from a delivery system after the fastener penetrates through the interior surface of the heart chamber and into the myocardial wall, the detachment mechanism being spaced apart from the fastener.

14. The wireless electrode assembly of claim 13, wherein the detachment mechanism includes a threaded member.

15. The wireless electrode assembly of claim 10, wherein the first and second electrodes provide the pacing electrical pulse to the myocardial wall with a voltage pulse amplitude greater than 0.5 Volts.

16. The wireless electrode assembly of claim 15, wherein the voltage pulse amplitude of the pacing electrical pulse is about 2 Volts.

17. The wireless electrode assembly of claim 15, wherein the pacing electrical pulse provided by the first and second electrodes provides a pulse duration of approximately 0.4 msec.