Non-intrusive analgesic neuroaugmentive and iontophoretic delivery apparatus and management system

• US 5,571,149 A
• Filed: 04/13/1994
• Issued: 11/05/1996
• Est. Priority Date: 05/21/1991
• Status: Expired due to Term

• Current Assignee: Bernard Liss, Fisher Wallace Laboratories, Saul Liss
• Original Assignee: E.P. Inc.
• Inventors: Liss, Saul, Liss, Bernard
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US08/227,014
• Time in Patent Office: 937 Days
• Field of Search: 604/20, 607/46, 607/72
• US Class Current: 607/72
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/36021 for treatment of pain

Abstract

The present invention pertains to a portable non-invasive electronic apparatus which can be used to relieve pain or alter the symptoms of certain neurological dysfunctions. A specifically contoured constant current and current limited waveform is generated and applied to selectively positioned electrodes. A program controlled processor tracks usage of the unit to prevent abuse and monitor progress. An overall treatment regimen centered on the stimulator may be effected simply and safely. The invention also provides an apparatus and method for the iontophoretic topical administration of a pharmaceutical agent. The apparatus is operated in a monopolar mode with a particular complex waveform which synergistically enhances the amount of various neurobiochemical species in the cerebral spinal fluid and the blood plasma.

Claims

1. In combination, in a system for the iontophoretic topical delivery of a pharmaceutically active agent, said system comprising:

a. means for generating a substantially constant current pulsed DC output voltage;

b. means for converting said output voltage into an n-modulated output adjustable constant current waveform, wherein n is an integer;

c. a pharmaceutically active agent effective for topical administration;

d. contact means for containing and delivering said pharmaceutically active agent to a topical area of a patient in need of treatment, said contact means including at least two electrodes;

e. means for directing said n-modulated output waveform to said contact means;

wherein said n-modulated output waveform comprises a first waveform component ranging between 1 and 300,000 KHz, a second waveform component ranging between 10 and 199,000 Hz, and a third waveform component ranging between 100 and 300,000 Hz, and each waveform component is substantially time invariant and distinct from said other waveform components, said double modulated output waveform having a monopolar characteristic.

2. The system of claim 1 wherein said first waveform component has a 50% duty cycle, and said second waveform component has a 75% duty cycle but not limited thereto.

3. The system of claim 1, wherein the first waveform ranges from about 10 Hz to about 100 KHz.

4. The system of claim 3, wherein the first waveform ranges from about 10-50 KHz.

5. The system of claim 4, wherein said second waveform component ranges from about 10 KHz to about 20 KHz.

6. The system of claim 1, wherein said third waveform ranges from about 100 Hz to about 100 KHz.

7. The system of claim 1, wherein said first waveform component is approximately 15,000 Hz, said second waveform component is approximately 15 Hz, and said third waveform component is approximately 500 Hz.

8. The system of claim 1, wherein the pharmaceutical agent is selected from the group consisting of anti-inflammatory agents, proteins and/or hormones, nicotine, antianginal and/or vasodilator compounds, vitamins and cofactors, antihypertensives, and anesthetics.

9. The system of claim 8, wherein the pharmaceutical agent is selected from the group consisting of hydrocortisone, insulin, nicotine, nitroglycerin, nicotinic acid, propranolol, and lidocaine.

10. In combination, in a system for the treatment of certain neural responsive conditions, said system comprising:

a. means for generating a substantially constant current pulsed DC output voltage;

b. means for converting said output voltage into an n-modulated output adjustable constant current waveform;

c. contact means comprising at least two contacts for conducting said n-modulated output adjustable constant current to a mammalian host;

d. means for directing said n-modulated output waveform across said at least two contacts;

wherein said n-modulated output waveform comprises a first waveform component ranging between 1 KHz and 300 GHz, a second waveform component ranging between 1 and 199,000 Hz, a third waveform component ranging between 100 and 300,000 Hz, and a fourth waveform component ranging from 0.1 Hz to 1,000 Hz, each waveform component being substantially time invariant and distinct from said other waveform components, said n-modulated output waveform having a monopolar characteristic.

11. The system of claim 10, wherein said first waveform component has a 50% duty cycle and said second waveform component has from about a 50% duty cycle to about a 75% duty cycle.

12. The system of claim 10, further comprising a means for intermittently reversing polarity of said n-modulated waveform.

13. The system of claim 10, wherein said first waveform component is a carrier frequency of 20-100 GHz.

14. The system of claim 10, wherein said second waveform component is a modulation frequency in the range of 10-1000 Hz.

15. The system of claim 10, wherein said third waveform component is a modulation frequency of 15 KHz±

5 KHz.

16. The system of claim 10, wherein said fourth waveform component is a modulation frequency in the range of 1-50 Hz.

17. The system of claim 10, wherein said first waveform component has a frequency in the range of 50-75 GHz, said second waveform component has a frequency in the range of 500±

50 Hz, said third waveform component has a frequency in the range of 15 KHz±

2 KHz, and said fourth waveform has a frequency in the range of 5-25 Hz.

18. In combination in a method for the treatment of pain or symptoms of neural dysfunction distress, comprising the steps of:

a. developing a treatment regimen comprising a series of individual treatment sessions;

b. programming an n-modulated waveform generator with said treatment regimen;

c. monitoring and recording an implementation of said treatment regimen with said n-modulated waveform generator; and

d. replaying a historical account of said treatment regimen for review;

wherein said n-modulated waveform generator generates a first waveform component ranging between 1 KHz and 300 GHz, a second waveform component ranging between 10 and 199,000 Hz, a third waveform component ranging between 100 and 300,000 Hz, and fourth waveform component ranging from 0.1 Hz to 1,000 Hz.

19. The method of claim 18, wherein said first waveform component has a frequency in the range of 50-75 GHz, said second waveform component has a frequency in the range of 500±

50 Hz, said third waveform component has a frequency in the range of 15 KHz±

2 KHz, and said fourth waveform has a frequency in the range of 5-25 Hz.

20. The method of claim 18, wherein said waveform generator further includes an abuse-preventing circuit that automatically stops any waveform output when usage exceeds a pre-programmed limit.