Methods and systems for direct electrical current stimulation as a therapy for cancer and other neoplastic diseases

• US 6,901,296 B1
• Filed: 04/26/2002
• Issued: 05/31/2005
• Est. Priority Date: 05/25/2001
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Whitehurst, Todd K., McGivern, James P., Kuzma, Janusz A.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/133,768
• Time in Patent Office: 1,131 Days
• Field of Search: 607/1, 607/2, 607/50, 607/100, 604/20, 604/21, 128/898, 128/899
• US Class Current: 607/50
• CPC Class Codes: A61N 1/205 for promoting a biological process
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

A small implantable stimulator(s) includes at least two electrodes for delivering electrical stimulation to surrounding tissue. The small stimulator provides means of stimulating a neoplasm with direct electrical current, such as relatively low-level direct current, without the need for external appliances during the stimulation session. The stimulator may be configured to be small enough to be implanted entirely within a neoplasm. Open- and closed-loop systems are disclosed.

Claims

1. A method for treating a patient with neoplastic disease, comprising:

providing at least one stimulator having at least two electrodes;

implanting the at least one stimulator in a neoplasm;

providing operating power to the at least one stimulator;

providing stimulation parameters to the at least one stimulator;

generating direct electric current in accordance with the stimulation parameters; and

delivering the current to neoplastic tissue near the at least one stimulator;

wherein the at least one stimulator has a size and shape suitable for placement entirely within the neoplasm.

2. The method of claim 1 wherein the direct electric current is delivered at a relatively low level.

3. The method of claim 2 wherein the relatively low-level direct electric current is delivered at between about 0.1 mA and about 10.0 mA.

4. The method of claim 1 further comprising

providing at least one sensor;

using the at least one sensor to sense at least one physical condition; and

providing the stimulation parameters based at least in part upon the at least one sensed condition.

5. The method of claim 4 wherein the sensed physical condition includes at least one of tissue necrosis, tissue volume, pressure, oxygen level, impedance, neurotransmitter level, change in neurotransmitter level, pH level, change in pH level, hormone level, hormone level change, enzyme level, change in enzyme level, ketone level, change in ketone level, electrolyte level, change in electrolyte level, interleukin level, change in interleukin level, cytokine level, change in cytokine level, lymphokine level, change in lymphokine level, chemokine level;

change in chemokine level, growth factor level, change in growth factor level, medication level, medication level change, drug level, change in drug level, level of AFP, change in AFP level, level of AFu, change in AFu level, level of GGT, change in GGT level, level of SA, change in SA level, level of CEA, change in CEA level, EMG, level of a blood-borne substance, change in the level of a blood-borne substance, level of a local interstitial fluid, and change in the level of a local interstitial fluid.

6. The method of claim 4 wherein the at least one sensor is a part of the stimulator.

7. The method of claim 1 wherein the at least one stimulator is leadless.

8. The method of claim 7 further comprising providing and implanting more than one stimulator.

9. A microstimulator for treating a patient with neoplastic disease, comprising:

electrical circuitry controlling electrical stimulation delivered to a neoplasm;

at least two electrodes electrically connected to the electrical circuitry and configured to deliver the electrical stimulation to the neoplasm; and

wherein the microstimulator is configured for implantation entirely within or near the neoplasm.

10. The microstimulator of claim 9 wherein the electrical circuitry is configured to generate direct electric current to be delivered via the electrodes at between about 0.1 mA and about 1 mA.

11. The microstimulator of claim 9 wherein the microstimulator is substantially cylindrical-shaped.

12. The microstimulator of claim 9 wherein the microstimulator is substantially pancake-shaped.

13. The microstimulator of claim 9 wherein the microstimulator is substantially spherical-shaped.

14. The microstimulator of claim 9 further comprising at least one sensor for sensing at least one physical condition.

15. The microstimulator of claim 14 further configured to control stimulation at least in part according to the at least one sensed physical condition.

16. A method for treating a patient with neoplastic disease, comprising:

providing at least one stimulator having at least two electrodes;

implanting at least one electrode of the at least one stimulator in a neoplasm;

providing operating power to the at least one stimulator;

providing stimulation parameters to the at least one stimulator;

delivering direct electric current in accordance with the stimulation parameters to neoplastic tissue near the at least two electrodes;

wherein the at least one stimulator has a size and shape suitable for placement entirely within or near the neoplasm.

17. The method of claim 16, further comprising:

providing at least one sensor;

using the sensor to sense a physical condition; and

determining the stimulation parameters based at least in part upon the sensed condition.

18. The method of claim 17 wherein the at least one sensor is a part of the stimulator.

19. The method of claim 16 wherein the stimulation parameters are determined using at least one external appliance.

20. The method of claim 16 wherein the stimulation parameters are determined by the at least one stimulator.

21. The method of claim 16 wherein the stimulation parameters are fixed.

22. The method of claim 16 wherein providing power to the at least one stimulator comprises receiving power from at least one external appliance.

23. The method of claim 22 wherein providing power to the at least one stimulator further comprises storing the power received from the at least one external appliance.

24. The method of claim 16 wherein the at least one stimulator is leadless.

25. The method of claim 16 further comprising providing and implanting more than one stimulator.

26. The method of claim 16 wherein the sensed physical condition includes at least one of tissue necrosis, tissue volume, pressure, oxygen level, impedance, neurotransmitter level, change in neurotransmitter level, pH level, change in pH level, hormone level, hormone level change, enzyme level, change in enzyme level, ketone level, change in ketone level, electrolyte level, change in electrolyte level, interleukin level, change in interleukin level, cytokine level, change in cytokine level, lymphokine level, change in lymphokine level, chemokine level, change in chemokine level, growth factor level, change in growth factor level, medication level, medication level change, drug level, change in drug level, level of AFP, change in AFP level, level of AFu, change in AFu level, level of GGT, change in GGT level, level of SA, change in SA level, level of CEA, change in CEA level, EMG, level of a blood-borne substance, change in the level of blood-borne substance, level of a local interstitial fluid, and change in the level of a local interstitial fluid.