Leadless cardiac stimulation systems

• US 7,532,933 B2
• Filed: 10/20/2004
• Issued: 05/12/2009
• Est. Priority Date: 10/20/2004
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Drasler, William J., Hastings, Roger N., Smith, Scott R., Lafontaine, Daniel M., Sadasiva, Anupama
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K
• Application Number:
  US10/971,550
• Publication Number:
  US 20060085039A1
• Time in Patent Office: 1,665 Days
• Field of Search: 607/30, 607/32, 607/60, 607/61, 607/33
• US Class Current: 607/33
• 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 1/3627 for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/365 controlled by a physiological parameter, e.g. heart potential evoked response A61N1/371
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• 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 electrodes that are implantable at sites proximate the myocardium using a percutaneous, transluminal, catheter delivery system. Each of the electrodes contains a source of electrical energy for pacing the myocardium and is adapted to receive electromagnetic energy from a source outside the myocardium. The system also includes a source adapted for placement outside the myocardium and that uses locally measured electrocardiograms to synchronize pacing of the heart by sending electromagnetic commands to the electrodes to pace the myocardium surrounding the electrodes. Also disclosed is various configurations of such systems, wireless electrode assemblies, and delivery catheters for delivering and implanting the electrode assemblies.

Claims

1. A system comprising:

a wireless electrostimulation electrode assembly comprising electrostimulation electrodes, the wireless electrostimulation electrode assembly sized and shaped for implant at a myocardial site using a percutaneous, transluminal, catheter delivery system, the wireless electrostimulation electrode assembly configured to receive electromagnetic energy from a source outside the myocardium;

a source of electromagnetic energy sized and shaped for placement within a person'"'"'s body outside the myocardium and separate and detached from the wireless electrostimulation electrode assembly, the source of electromagnetic energy including or conductively coupled to sensing electrodes that are configured to sense a locally measured electrogram to time an electrostimulation of the heart by wirelessly sending a command to the wireless electrostimulation electrode assembly to electrostimulate the myocardium;

wherein the source of electromagnetic energy comprises an electronic control circuit, a transmit circuit, a battery, and an antenna; and

wherein the locally measured electrogram is sensed by the sensing electrodes included in or conductively coupled to the source of electromagnetic energy.

2. The system of claim 1 wherein the wireless electrostimulation electrode assembly comprises a coil that is configured to be inductively coupled to the source of electromagnetic energy.

3. The system of claim 2 wherein the source of electromagnetic energy is configured to charge the wireless electrostimulation electrode assembly, by inductive coupling electromagnetic energy at a specified first frequency range common to a plurality of wireless electrostimulation electrode assemblies and wherein the wireless electrostimulation electrode assembly comprises a capacitor configured to provide the source of electrical energy for use in electrostimulation of the myocardium.

4. The system of claim 2 wherein the wireless electrostimulation electrode assembly comprises:

a source of electrical energy configured for- electrostimulation of the myocardium; and

wherein the source of electromagnetic energy is configured such that the inductively coupled electromagnetic energy comprises a command to the wireless electrostimulation electrode assembly electrostimulate the myocardium.

5. The system of claim 4 in which the source of electrical energy for use in electrostimulation of the myocardium includes a battery within the wireless electrostimulation electrode assembly.

6. The system of claim 4 wherein the source of electromagnetic energy is configured such that the command to electrostimulate the myocardium comprises an electromagnetic signal inductively coupled to the coil in the wireless electrostimulation electrode assembly from the source of electromagnetic energy, the electromagnetic signal including energy within a specified frequency range that is particular to the implanted wireless electrostimulation electrode assembly.

7. The system of claim 1 in which the battery is rechargeable.

8. The system of claim 7, configured such that energy to recharge the battery comprises electromagnetic energy inductively coupled to the antenna from a source outside the person'"'"'s body.

9. The system of claim 1 comprising first and second neighboring wireless electrostimulation electrode assemblies that are inductively coupled to each other, and configured such that an inductively received signal from the first neighboring wireless electrostimulation electrode assembly determines at least in part a time that the second electrostimulation electrode assembly electrostimulates the myocardium.

10. The system of claim 1, wherein the source of electromagnetic energy comprises an implantable controller device comprising a housing that is sized to fit within the person'"'"'s body in a space outside the heart and proximate to two or more ribs.

11. The system of claim 10, wherein the sensing electrodes are configured on a surface of the housing to detect a subcutaneous electrogram when the controller device is implanted within the body.

12. The system of claim 10, wherein the housing of the controller device is configured to be anchored to two or more ribs when the controller device is implanted within the body.

13. The system of claim 12, wherein the housing of the controller device includes a curved body that is curved so as to fit between the two or more ribs.

14. The system of claim 12, wherein the housing of the controller device has a length of about 5 cm to about 10 cm.

15. The system of claim 10, wherein the housing is sized and shaped to include the battery of the source of electromagnetic energy.

16. The system of claim 15, further comprising an external programmer device that is configured to inductively couple with the antenna to recharge the battery included in the housing.

17. The system of claim 16, wherein the external programmer device is configured to wirelessly communicate with the controller device, when the controller device is implanted within the body, so as to set one or more operation parameters.

18. The system of claim 17, wherein at least one of the operation parameters is selected from the group consisting of electrostimulation pulse timing, electrostimulation pulse energy level, and electrostimulation pulse duration.

19. The system of claim 1, wherein the wireless electrostimulation electrode assembly includes one or more tines that are configured to penetrate from an internal heart chamber into the myocardium when the wireless electrostimulation electrode assembly is implanted.

20. The system of claim 19, wherein the wireless electrostimulation electrode assembly comprises a proximal electrode surface and a distal electrode surface that are configured to electrostimulate to the myocardium when the wireless electrostimulation electrode assembly is implanted.

21. The system of claim 20, wherein each of the wireless electrostimulation electrode assembly is configured to provide an electrostimulation pulse of about 2.5 Volts to the myocardium when the wireless electrostimulation electrode assembly is implanted.