Electrical stimulation apparatus and method

• US 20010034544A1
• Filed: 04/02/2001
• Published: 10/25/2001
• Est. Priority Date: 09/18/1998
• Status: Active Grant

• Current Assignee: Nexmed Holdings
• Original Assignee: Nexmed Holdings
• Inventors: Mo, Y. Joseph
• Granted Patent: US 6,594,527 B2
• Time in Patent Office: Days
• US Class Current: 607/59
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/36 for stimulation
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An electrical stimulation apparatus and method for providing electrical stimulation to tissue. The electrical stimulation apparatus includes a base unit and an electrode module. The base unit is configured to be hand portable and contains a first electrical circuit and a first battery for supplying electrical energy to the first electrical circuit. A second electrical circuit and a second battery provide a time/date function. The base unit supports an LCD to provide a visual indication of the various functions of the electrical stimulation apparatus. The electrode module is programmable to enable the prescribing physician to set the treatment protocol for the electrical stimulation apparatus. The present apparatus is particularly well suited for the treatment of herpes simplex and herpes zoster.

Claims

1. An electrical stimulation apparatus comprising:

a housing;

a display on said housing for visually displaying selected information;

a first electrical circuit and a first battery electrically coupled thereto in said housing for electrical stimulation of tissue by a series of alternating monopolar bursts of current;

a second electrical circuit and a second battery electrically coupled to said second electrical circuit, said second electrical circuit providing a second source of electrical energy for operating said display;

an electrode module configured to be selectively coupled to said housing, in operable electrical connection with said first electrical circuit and including a key for enabling energization of said first electrical circuit.

2. The electrical stimulation apparatus defined in

claim 1

, wherein said key is associated with probe control logic for preprogramming said probe control logic with a preselected treatment protocol for said first electrical circuit.

3. The electrical stimulation apparatus defined in

claim 2

wherein said key is configured as a disposable element to accommodate disposal of said key upon completion of said preselected treatment protocol.

4. The electrical stimulation apparatus defined in

claim 2

wherein said display includes a prompt for prompting a user of said electrical stimulation apparatus to follow said preselected treatment protocol.

5. The electrical stimulation apparatus defined in

claim 2

wherein said display includes a treatment status display for displaying the status of the treatment delivered by said electrical stimulation apparatus.

6. The electrical stimulation apparatus defined in

claim 1

wherein said display includes a battery status display for displaying the status of said first battery.

7. An apparatus for enabling a prescribing physician to selectively prescribe a predetermined prescription of electrical stimulation to a tissue of the patient comprising:

a housing, said housing being configured to be hand portable;

a first electrical circuit in said housing for emitting a pair of monopolar bursts of current having opposite polarity when said first electrical circuit is energized;

a first battery in said housing, said first battery being operable to deliver electrical energy to said first electrical circuit;

an electrode module removably mounted to said housing;

a second electrical circuit in said electrode module, said second electrical circuit being electrically coupled to said first electrical circuit when said electrode module is mounted to said housing;

electrodes on said electrode module, said electrodes extending outwardly from said electrode module to enable said electrodes to be placed in contact with the tissue of the patient, said electrodes being in electrical connection with said second electrical circuit; and

programming means in said second electrical circuit for enabling the prescribing physician to selectively program said electrode module with said predetermined prescription of electrical stimulation for the tissue of the patient.

8. The apparatus defined in

claim 7

wherein said housing includes a display for displaying information relative to said predetermined prescription of electrical stimulation.

9. The apparatus defined in

claim 7

wherein said information displayed includes the number of treatments in said predetermined prescription remaining in said electrode module.

10. The apparatus defined in

claim 7

wherein said information displayed includes instructions to the patient for the activation of said electrical stimulation.

11. The apparatus defined in

claim 7

wherein said information displayed includes the status of said first electrical circuit.

12. The electrical stimulation apparatus defined in

claim 7

wherein said display includes an alarm to remind the user to use said electrical stimulation apparatus.

13. The electrical stimulation apparatus defined in

claim 7

wherein said display includes an error display in the event said first electrical circuit is activated in the absence of said electrode module.

14. A method for providing electrical stimulation to tissue comprising the steps of:

preparing a first electrical circuit operable to deliver said electrical stimulation;

interconnecting a first battery to said first electrical circuit;

enclosing said first electrical circuit and said first battery in a housing; and

providing an electrode module for delivering said electrical stimulation to the tissue from said first electrical circuit, said electrode module being selectively mountable to said housing and containing preprogrammable means for programming said first electrical circuit when said electrode module is mounted to said housing in electrical connection to said first electrical circuit.

15. The method defined in

claim 14

wherein said providing step includes selectively programming said preprogrammable means with a predetermined treatment protocol for a patient.

16. The method defined in

claim 15

wherein said selectively programming step includes modifying said treatment protocol for the patient by reprogramming said preprogrammable means.

17. The method defined in

claim 14

wherein said enclosing step includes providing a visual display on said housing for displaying information relative to said electrical stimulation.

18. A method for providing a preselected electrical stimulation to the tissue of a patient comprising the steps of:

preparing a first electrical circuit, said first electrical circuit including a first battery;

enclosing said first electrical circuit in a housing, said housing being configured to be hand portable;

assembling a second electrical circuit, said second electrical circuit including programming means for programming said second electrical circuit;

placing said second electrical circuit in an electrode module;

mounting a pair of electrodes to said electrode module in electrical communication with said second electrical circuit;

programming said programming means in said second electrical circuit with a predetermined treatment protocol for said preselected electrical stimulation;

coupling said second electrical circuit to said first electrical circuit; and

activating said first electrical circuit and said second electrical circuit while contacting the tissue with said pair of electrodes thereby directing said preselected electrical stimulation to the tissue.

19. The method defined in

claim 18

wherein said enclosing step includes providing a display on said housing, said display displaying information regarding said electrical stimulation.

20. A method of treatment of herpes simplex and herpes zoster which comprises the steps of:

applying seriatim a pair of alternating monopolar bursts of current to a skin region to be treated at a current intensity of up to about 30 milliamperes;

each burst of current having a duration of about 10 seconds and consecutive bursts having opposite polarity.

21. The method in accordance with

claim 20

wherein the current intensity is about 9 milliamperes.

22. The method in accordance with

claim 20

wherein the current intensity is about 18 milliamperes.

23. The method in accordance with

claim 20

wherein the current intensity is about 27 milliamperes.

24. The method in accordance with

claim 20

wherein a time interval of up to about two seconds is maintained with no current to the skin region between consecutive bursts having opposite polarity.

25. The method in accordance with

claim 20

wherein a time interval of about one second is maintained with no current to the skin region between consecutive bursts having opposite polarity.

26. The method in accordance with

claim 20

wherein a voltage differential of about 9 volts is maintained across the skin region being treated.

27. The method in accordance with

claim 20

wherein the pair of alternating monopolar bursts of current is applied to the skin region about every hour over an eight hour period.

28. The method in accordance with

claim 20

wherein the treatment is carried out over a time period of not more than five days.

29. The method in accordance with

claim 20

wherein the treatment is carried out over a time period of one to three days.

30. The method in accordance with

claim 20

wherein the treatment is carried out over a time period of one to four days.