System and method for providing temporary stimulation therapy to optimize chronic electrical performance for electrodes used in conjunction with a cardiac rhythm management system

• US 7,110,815 B2
• Filed: 05/06/2002
• Issued: 09/19/2006
• Est. Priority Date: 05/06/2002
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kenknight, Bruce H., Heil, Ronald W. Jr.
• Primary Examiner(s): Pezzuto, Robert E.
• Assistant Examiner(s): DROESCH, KRISTEN L
• Application Number:
  US10/139,916
• Publication Number:
  US 20030208236A1
• Time in Patent Office: 1,597 Days
• Field of Search: 607 1- 5, 607 8- 9, 607/11, 607 27- 28, 604/20
• US Class Current: 607/11
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/3625 External stimulators

Abstract

A system and method for stimulating a human heart including a sensing module coupled through a lead to an electrode associated with a tissue of the human heart for sensing electrical activity of the heart. A controller module may be coupled to the sensing module. The controller module may select between a temporary stimulation therapy and a chronic stimulation therapy. Also included is a therapy module coupled to the controller, the therapy module communicating a plurality of anodic pulses to the heart through the lead when providing the temporary stimulation therapy. The amplitude, frequency, and duration of the anodic pulses may be varied, and biphasic pacing may also be used. The electrode may be a drug-eluting electrode for delivery of a drug. After an event occurs, the controller module may transition to the chronic stimulation therapy that may include cathodic stimulation.

Claims

1. A cardiac rhythm management system for stimulating a human heart, the system comprising:

a sensing module coupled through at least one lead to an electrode associated with a tissue of the human heart for sensing electrical activity of the heart;

a controller module coupled to the sensing module, wherein the controller module selects between a temporary stimulation therapy and a chronic stimulation therapy; and

a therapy module coupled to the controller, wherein the therapy module communicates a plurality of anodic pulses to the heart through the lead when providing the temporary stimulation therapy;

wherein the system initially operates using the temporary stimulation therapy and wherein the controller, upon detection of an event, selects the chronic stimulation therapy.

2. The system of claim 1, wherein a pulse duration of each of the plurality of anodic pulses is less than 1000 microseconds.

3. The system of claim 1, wherein the electrode further comprises a drug-eluting submodule, wherein the drug-eluting submodule releases at least one drug.

4. The system of claim 3, wherein the at least one drug includes an anti-inflammatory drug.

5. The system of claim 3, wherein timing for the release of the at least one drug by the drug-eluting submodule is set to coincide with a pulse duration of each of the plurality of anodic pulses.

6. The system of claim 3, wherein an amplitude of each of the plurality of anodic pulses is of sufficient magnitude to facilitate delivery of the drug.

7. The system of claim 1, wherein the therapy module further generates a plurality of cathodic pulses interspersed within the plurality of anodic pulses.

8. The system of claim 7, wherein each of the plurality of cathodic pulses is followed by at least one subthreshold anodic pulse from the plurality of anodic pulses.

9. The system of claim 7, wherein each of the plurality of cathodic pulses is followed by a train of subthreshold anodic pulses.

10. The system of claim 9, wherein an amplitude of each anodic pulse of the train of subthreshold anodic pulses is varied.

11. The system of claim 1, wherein the chronic stimulation therapy includes a plurality of cathodic pulses.

12. The system of claim 1, wherein the event is the stabilization of an impedance across the electrode.

13. The system of claim 1, wherein the event is the stabilization of a voltage stimulation threshold necessary to stimulate the heart tissue.

14. The system of claim 1, wherein the therapy module varies an amplitude of each of the plurality of anodic pulses.

15. The system of claim 1, wherein the therapy module varies a frequency of each of the plurality of anodic pulses.

16. The system of claim 1, wherein the therapy module varies a pulse duration of each of the plurality of anodic pulses.

17. A cardiac rhythm management system for stimulating a human heart, the system comprising:

a sensing module coupled through at least one lead to an electrode associated with a tissue of the human heart for sensing electrical activity of the heart;

a controller module coupled to the sensing module, wherein the controller module selects a selected therapy from at least two stimulation therapies including a temporary stimulation therapy and a chronic stimulation therapy, wherein the controller selects the temporary stimulation therapy upon implantation of the electrode and, after detection of an event, the controller module selects the chronic stimulation therapy; and

a therapy module coupled to the controller, wherein the controller module communicates the selected stimulation therapy to the therapy module and wherein the therapy module communicates a plurality of electrical pulses to the heart, through the at least one lead, based on the selected stimulation therapy, wherein the therapy module provides anodic stimulation for the temporary stimulation therapy and cathodic stimulation forte chronic stimulation therapy.

18. A method for reducing a tissue response to an implanted electrode used for stimulating a human heart, the method comprising steps of:

stimulating the heart using a temporary stimulation therapy including anodic stimulation;

detecting an event; and

stimulating the heart using a chronic stimulation therapy including cathodic stimulation upon detection of the event.

19. The method of claim 18, wherein the temporary stimulating step further comprises a step of generating an anodic pulse such that a pulse duration of the anodic pulse is short.

20. The method of claim 19, wherein the generating step further comprises a step of creating the anodic pulse such that the pulse duration of the anodic pulse is less than 1000 microseconds.

21. The meted of claim 18, further comprising steps of:

releasing a drug using a drug-eluting electrode; and

applying an anodic pulse of an amplitude such that the anodic pulse will both stimulate the heart and create electroporation to facilitate diffusion of the drug into the tissue.

22. The method of claim 18, further comprising a step of timing a release of a drug to coincide with a pulse duration of an anodic pulse.

23. The method of claim 18, farther comprising steps of:

releasing a drug exhibiting anti-inflammatory characteristics; and

allowing the drug to diffuse across a membrane of at least one cell of the tissue.

24. The method of claim 23, wherein the releasing step further comprises a step of selecting a bisphosphonate as the drug.

25. The method of claim 18, further comprising steps of:

releasing a combination of drugs exhibiting anti-inflammatory suppressive and cytotoxic characteristics; and

allowing the combination of drugs to diffuse across a membrane of the tissue surrounding the electrode.

26. The method of claim 18, wherein the temporary stimulating step further comprises a step of providing temporary stimulation therapy including biphasic stimulation.

27. The method of claim 26, wherein the providing step further comprises a step of forming a biphasic pulse to include equal cathodic and anodic components.

28. The method of claim 26, wherein the providing step further comprises a step of forming the biphasic stimulation to include a plurality of cathodic pulses and at least one subthreshold anodic pulse interspersed between adjacent cathodic pulses.

29. The method of claim 28, wherein the forming step further comprises varying an amplitude of the at least one subthreshold anodic pulse.

30. The method of claim 28, wherein the forming step further comprises varying a frequency of the at least one subthreshold anodic pulse.

31. The method of claim 28, wherein the forming step further comprises generating a plurality of subthreshold anodic pulses between each adjacent cathodic pulse, wherein a subthreshold anodic pulse following a cathodic pulse is greater in amplitude than other of the plurality of anodic pulses between each adjacent cathodic pulse.

32. The method of claim 18, wherein the detecting step further comprises steps of:

defining the event as a change in an impedance of the electrode; and

measuring the impedance of the electrode to determine when the impedance reaches an initial implantation level.

33. The method of claim 18, wherein the detecting step further comprises steps of:

defining the event as a change in voltage stimulation threshold; and

monitoring voltage stimulation thresholds to determine when the voltage stimulation threshold stabilizes.