Leadless cardiac stimulation systems

• US 7,650,186 B2
• Filed: 03/07/2005
• Issued: 01/19/2010
• Est. Priority Date: 10/20/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Edmunds, Kevin D., Hastings, Roger N., Sadasiva, Anupama, Pikus, Mike
• Primary Examiner(s): Layno; Carl H.
• Assistant Examiner(s): Heller; Tammie K.
• Application Number:
  US11/075,375
• Publication Number:
  US 20060085041A1
• Time in Patent Office: 1,779 Days
• Field of Search: 607/30, 607/32, 607/60, 607/61
• US Class Current: 607/32
• 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 system comprising:

a control unit configured with an antenna sized and shaped to produce a magnetic field; and

an implantable wireless batteryless electrostimulation electrode assembly configured (1) to receive magnetic energy from the magnetic field, (2) to directly convert the received magnetic energy into a specified tissue electrostimulation waveform without storing the received energy in a discrete capacitive storage device and without storing the received energy in an electrochemical storage device, (3) to be implanted from within a heart chamber into a heart chamber inner wall tissue site and to deliver the tissue electrostimulation waveform to the heart chamber inner wall tissue site in response to the magnetic field, and (4) to inhibit the delivery of the tissue electrostimulation waveform in response to the absence of the magnetic field.

2. The system of claim 1, wherein the antenna comprises a wire loop.

3. The system of claim 1, wherein the control unit is configured and shaped to be implanted in a human subject and the antenna is configured and shaped to be implanted under the skin of the subject in proximity to the implantable wireless batteryless electrostimulation electrode assembly.

4. The system of claim 1, wherein the control unit comprises:

a battery;

a capacitor electrically coupled to the antenna; and

a controllable switch configured to selectively enhance or inhibit charging and discharging of the capacitor in response to a control signal.

5. The system of claim 4, wherein the control unit is configured to generate a specified magnetic field waveform, and in response, an the implantable wireless batteryless electrostimulation electrode assembly is configured to generate a tissue electrostimulation waveform sufficient to provide a pacing level to the heart chamber inner wall tissue site.

6. The system of claim 1, wherein the implantable wireless batteryless electrostimulation electrode assembly comprises a wire coil encompassing a core, and wherein the core is configured to enhance an effective relative magnetic permeability.

7. The system of claim 6, wherein the wireless batteryless electrostimulation electrode assembly comprises at least two electrodes electrically coupled to the wire coil.

8. The system of claim 7, wherein the pair of electrodes comprise a pair of circular caps mechanically coupled to opposed ends of the core encompassed by the wire coil.

9. The system of claim 8, wherein the implantable wireless batteryless electrostimulation electrode assembly is less than or equal to a 5 millimeters length along a long axis and the pair of caps are sized and shaped to be less than or equal to a 3 millimeters diameter.

10. A method, comprising:

producing a magnetic field at a control unit at a first location;

receiving a magnetic field at an implantable wireless batteryless electrostimulation electrode assembly at a second location, the second location being a heart chamber inner wall accessed from within a heart chamber;

converting the received magnetic field into a specified tissue electrostimulation waveform without storing energy from the received magnetic field in a discrete capacitor and without storing the energy in an electrochemical storage device;

delivering the tissue electrostimulation waveform to a heart chamber inner wall tissue site in response to the magnetic field; and

inhibiting delivery of the tissue electro stimulation waveform in response to the absence of the magnetic field.

11. The method of claim 10, comprising:

delivering the implantable wireless batteryless electrostimulation electrode assembly into a chamber of a heart;

attaching the wireless batteryless electrode assembly to a wall of the chamber; and

delivering the tissue electrostimulation waveform to the heart chamber inner wall.

12. The method of claim 11, wherein the implantable wireless batteryless electrostimulation electrode assembly is introduced through an intravascular access catheter on the end of a flexible elongate member.

13. The method of claim 12, wherein the implantable wireless batteryless electrostimulation electrode assembly is directed to an endocardial location and screwed into the heart chamber inner wall tissue site.

14. The method of claim 13, comprising screwing a plurality of implantable wireless batteryless electrostimulation electrode assemblies into respective multiple distinct areas of heart chamber wall tissue through the interior lining of the heart.

15. The method of claim 13, comprising screwing a plurality of implantable wireless batteryless electrostimulation electrode assemblies into respective locations in heart chamber wall tissue, through the interior lining of the heart, within multiple respective chambers of the heart.

16. The method of claim 10, comprising:

generating a critically damped, exponentially decaying current waveform; and

energizing the antenna with the critically damped, exponentially decaying current waveform.

17. A system comprising:

an implantable control unit comprising;

an antenna comprising a wire loop to produce a magnetic field;

a battery configured to supply power to the implantable control unit;

a capacitor electrically coupled with the antenna; and

a controllable switch that controls a charge level associated with the capacitor; and

an implantable wireless batteryless electrostimulation electrode assembly configured (1) to receive magnetic energy from the magnetic field, (2) to directly convert the received magnetic energy into a specified tissue electrostimulation waveform without storing the received energy in a discrete capacitive storage device and without storing the received energy in an electrochemical storage device, (3) to be implanted from within a heart chamber into a heart chamber inner wall and to deliver the tissue electrostimulation waveform to a heart chamber inner wall tissue site in response to the magnetic field, (4) to inhibit the delivery of the tissue electrostimulation waveform in response to the absence of the magnetic field; and

wherein the control unit is configured to generate a specified magnetic field waveform, and in response, the wireless batteryless implantable electrostimulation electrode assembly is configured to generate a tissue electrostimulation waveform sufficient to provide a pacing level to the heart chamber inner wall tissue site.

18. The system of claim 17, wherein the control unit is sized and shaped to be implantable in a patient, and wherein the antenna is sized and shaped to be implanted under skin in proximity to the heart of the patient.

19. The system of claim 17, wherein an implantable wireless batteryless electrostimulation electrode assembly comprises a wire coil encompassing a core, and wherein the core is configured to enhance an effective relative magnetic permeability.

20. The system of claim 17, wherein the implantable wireless batteryless electrostimulation electrode assembly comprises a fastener to penetrate through an interior surface of a heart chamber and into a myocardial wall, and wherein at least one of the electrodes is configured to deliver the specified tissue electrostimulation to the myocardial wall when the fastener penetrates through the interior surface of the heart chamber and into the myocardial wall.

21. The system of claim 20, wherein the fastener comprises a combination of at least one helical tine, and at least one barb.

22. The system of claim 17, wherein each of the electrode assemblies deliver excitation pulses to the myocardial wall with a voltage pulse amplitude greater than 0.5Volts.

23. The system of claim 22, wherein the voltage pulse amplitude of the pacing electrical pulse is about 2 Volts.

24. The system of claim 22, wherein the pacing electrical pulse provided by the first and second electrodes provides a pulse duration of approximately 0.4 msec.

25. A method comprising:

delivering an implantable wireless batteryless electrostimulation electrode assembly to an interior surface of a heart chamber wherein the implantable wireless batteryless electrostimulation electrode assembly is sized and shaped for implantation via an intravascular route; and

anchoring the implantable wireless batteryless electrostimulation electrode assembly into a myocardial wall tissue site accessed from within a heart chamber;

implanting a control unit at an intra-body location external to a heart chamber;

energizing an antenna to produce a magnetic field in a heart chamber;

receiving the magnetic field at an implantable wireless electrostimulation electrode assembly; and

activating the control unit to energize the antenna and to produce a magnetic field such that the implantable wireless batteryless electrostimulation electrode assembly receives and directly converts, without storing energy from the received magnetic field in a discrete capacitor and without storing the energy in an electrochemical storage device, a portion of the energy from the received magnetic field into a specified tissue electrostimulation waveform at the myocardial tissue wall site.

26. The method of claim 25, comprising introducing the implantable wireless batteryless electrostimulation electrode assembly into a patient through an intravascular delivery catheter, and implanting the implantable wireless batteryless electrostimulation electrode assembly into a myocardial wall tissue site via an endocardial route.

27. The method of claim 26, comprising introducing the electrode assemblies through the delivery catheter on the end of a flexible elongate member.

28. The method of claim 25, comprising:

generating a critically damped, exponentially decaying current waveform; and

energizing the antenna with the critically damped, exponentially decaying current waveform.