Implantable device and method for the electrical treatment of cancer

• US 20020077676A1
• Filed: 12/14/2001
• Published: 06/20/2002
• Est. Priority Date: 04/09/1999
• Status: Active Grant

• Current Assignee: Onco Stim
• Original Assignee: Onco Stim
• Inventors: Kroll, Mark W., Schroeppel, Edward A.
• Granted Patent: US 6,738,663 B2
• Time in Patent Office: Days
• US Class Current: 607/75
• CPC Class Codes: A61K 47/6957 the form being a device or a kit, e.g. stents or microdevices
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/205 for promoting a biological process
• 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 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

An implantable electrical method and apparatus for the treatment of cancer tumors based on the usage of various levels of electrical fields and current to assist in specific ways to reduce tumor size. The appropriate voltage, currents, and time duration as well as the usage of adjunctive pharmacological therapy are taught.

Claims

1. An implantable medical device for the treatment of cancer consisting of:

a battery and circuitry, where the battery and circuitry are both contained within a hermetically sealed device housing, and at least one electrode where the battery is operably connected to the circuitry, the circuitry is operably connected to the electrode, and the circuitry is capable of delivering direct current electrical therapy for over about 1 minute essentially continuously to at least one electrode thereby reducing the size of solid cancer tumors.

2. The device of claim 1 in which the electrical therapy involves the use of multiple voltages.

3. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves the application of voltages between 1 volt and 20 volts.

4. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves the application of voltages for a time period of between 1 minute and 1 day.

5. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves voltages and time periods sufficient for changing the pH by at least 2.0 inside a tumor.

6. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves the application of voltages of between 20 mV and 500 mV.

7. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves the application of voltages for a time period of between 1 hour and 1 week.

8. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves voltages and time periods useful for attracting white blood cells.

9. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves the application of voltages of between 100 mV and 10 V.

10. The device of claim 1 in which the electrical therapy which the device is capable of delivering involves the application of voltages for a time period of between 1 to 120 minutes.

11. The device of claim 1 in which the electrical therapy which the device is capable of delivering is powered by an external power source rather than by said battery.

12. The device of claim 1 in which the electrical therapy which the device is capable of delivering also involves the application of voltage pulses of between 20 and 900 volts.

13. The device of claim 1 in which the electrical therapy which the device is capable of delivering also involves the application of voltage pulses with a pulse width of between 100 μ

s and 20 ms.

14. The device of claim 1 in which the electrical therapy which the device is capable of delivering also involves the application of voltage pulses with a spacing period of between 100 μ

s and 1 second.

15. The device of claim 12 in which the electrical therapy which the device is capable of delivering involves the application of between 1 and 10,000 voltage pulses.

16. The device of claim 1 in which the electrical therapy which the device is capable of delivering also involves voltages and pulse widths useful for forcing open tumor cell membranes to better allow the flow of therapeutic substances.

17. The device of claim 1 in which the device is capable of monitoring at least one voltage from within tissue.

18. The device of claim 17 in which the electrical therapy which the device is capable of delivering is adjusted according to the sensed tissue voltage.

19. The device of claim 18 in which the electrical therapy which the device is capable of delivering involves voltages in the range of 20 mV to 500 mV.

20. The device of claim 18 in which the electrical therapy which the device is capable of delivering involves time durations in the range of 1 hour to 1 month.

21. The device of claim 1 in which the electrical therapy which the device is capable of delivering to the at least one electrode involves both positive and negative voltages.

22. The device of claim 1 in which an electrical port contact is added to the side in order to receive externally generated electrical therapies.

23. The device of claim 1 with the additional element of a drug reservoir.

24. The device of claim 1 with the additional element of a drug pump.

25. The device of claim 1 with the additional element of a communication means to synchronize therapy with a drug delivery system.

26. The device of claim 1 with the additional element of circuitry to alternate output polarities to reduce the levels of electrode corrosion and degradation.

28. The method of claim 27 with the additional step of delivering a therapeutic electrical current.

29. The method of claim 27 with the additional step of synchronizing a therapeutic electrical current delivery.

30. The method of claim 27 with the additional step of synchronizing the delivering of the chemotherapeutic drug to a therapeutic electrical current delivery.

31. The method of claim 27 with the additional step of synchronizing the delivering of the chemotherapeutic drug to the circadian rhythm.

32. The method of claim 27 in which the step of delivering of the chemotherapeutic drug is performed through the use of a catheter with a fixation means.

33. The method of claim 27 in which the step of delivering of the chemotherapeutic drug is performed through the use of a catheter which also delivers electrical therapy.

27. A method of treating solid tumor cancers comprising the steps of:

(1) implanting at least one catheter into or near a tumor, (2) implanting a source of chemotherapeutic drug, (3) connecting the catheter to the source of chemotherapeutic drug, and (4) delivering the chemotherapeutic drug into the tumor from the source of chemotherapeutic drug.

34. A method of treating solid tumor cancers comprising the steps of:

(1) implanting at least one electrode into or near a tumor, (2) implanting a source of electrical power, (3) connecting the electrode to the source of electrical power and (4) delivering electrical current into the tumor with alternating polarities in order to deliver the electrical therapy to the tumor without causing extensive corrosion of the electrodes.