PAIN MODULATION SYSTEMS AND METHODS

• US 20120083858A1
• Filed: 06/11/2010
• Published: 04/05/2012
• Est. Priority Date: 06/11/2009
• Status: Active Grant

• Current Assignee: Theranica Bio-Electronics, Ltd.
• Original Assignee: David Yarnitsky
• Inventors: Yarnitsky, David
• Granted Patent: US 8,774,925 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5002 Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
• CPC Class Codes: A61H 2201/5005 for controlling frequency distribution, modulation or interference of a driving signal
• CPC Class Codes: A61H 2201/5035 Several programs selectable
• CPC Class Codes: A61H 2201/5041 control is restricted to certain individuals
• CPC Class Codes: A61H 2201/5097 wireless
• CPC Class Codes: A61H 39/002 Using electric currents electrotherapy A61N1/32
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36075 Headache or migraine

Abstract

Systems and methods of conducing a conditioning modulation of pain perception are disclosed. The system includes a power source, an impulse generator, a controller and at least one electrode for the delivery of a therapeutic stimulation.

Claims

1. A system for conducing a conditioning modulation of pain perception (CPM) said system comprises:

[a] a power source;

[b] an impulse generator, electrically connected to said power source and receiving energy therefrom;

[c] a controller electrically connected to said impulse generator and controlling the operation thereof, and

[d] at least one electrode for the delivery of a therapeutic CPM stimulation, said electrode is electrically connected to said impulse generator;

wherein said controller is programmed with the regime for delivery of said therapeutic CPM stimulation;

wherein said therapeutic CPM stimulation is delivered by said electrode to peripheral nerve fibers;

wherein said therapeutic CPM stimulation is achieved via activation of the Diffuse Noxious Inhibitory Control (DNIC) mechanism.

2. The system as in claim 1, further comprising at least one multi-site electrode.

3. The system as in claim 1, further comprising at least one multi-site electrode with a common return ground point.

4. The system as in claim 1, further comprising at least one multi-site electrode wherein each said sits comprises an individual return ground point.

5. The system as in claim 1, wherein said controller is programmed to deliver said therapeutic CPM stimulation percutaneously.

6. The system as in claim 1, wherein said controller is programmed to deliver said therapeutic CPM stimulation at sub-threshold levels, relatively to the subjective pain threshold of a patient.

7. The system as in claim 1, further comprising at least one inductive coil associated with said power source.

8. The system as in claim 1, wherein said controller further comprises a wireless communication module, for connection with an external programmer of said system.

9. The system as in claim 1, wherein said electrode is adapted to be topicaly disposed on patient'"'"'s skin.

10. The system as in claim 1, wherein said electrode is adapted to be implanted subcutaneously.

11. The system as in claim 1, wherein said system is implantable.

12. A device for conducing a conditioning modulation of pain perception (CPM) said device comprises:

[a] a power source;

[b] an impulse generator, electrically connected to said power source and receiving energy therefrom;

[c] a controller electrically connected to said impulse generator and controlling the operation thereof, and

wherein said impulse generator is connectable to at least one electrode, implemented for the delivery of a therapeutic CPM stimulation to peripheral nerve fibers, and

wherein said controller is programmed with the regime for delivery of said therapeutic CPM stimulation, wherein said therapeutic CPM stimulation is associated with an activation of the Diffuse Noxious Inhibitory Control (DNIC) mechanism.

13. The device as in claim 12, further comprising at least one electrode.

14. The device as in claim 12, further comprising at least one multi-site electrode.

15. The device as in claim 12, wherein said controller is programmed to deliver said therapeutic CPM stimulation percutaneously.

16. The device as in claim 12, wherein said controller is programmed to deliver said therapeutic CPM stimulation at sub-threshold levels, relatively to the subjective pain threshold of a patient.

17. The device as in claim 12, further comprising at least one inductive coil associated with said power source.

18. The device as in claim 12, wherein said controller further comprises a wireless communication module, for connection with an external programmer of said device.

19. A method of conducing a conditioning modulation of pain perception (CPM), said method comprises:

[a] identifying a patient;

[b] determining the CPM profile of said patient, comprising;

[i] subjecting said patient to a conditioning stimulus (CS);

[ii] subjecting said patient to a test stimuli (TS), jointly and severally to said conditioning stimulus (CS), and

[iii] rating the intensities of pain sensations evoked by said TS, respectively with and without said CS;

[iv] evaluating the difference between said ratings obtained with and without said CS;

thereby assessing the susceptibility of said patient to CPM therapy;

[c] selecting at least one site suitable for the delivery of a therapeutic CPM stimulation;

wherein said selection is performed in accordance with the Diffuse Noxious Inhibitory Control (DNIC) paradigm;

[d] applying said therapeutic CPM stimulation to at least one said suitable site;

thereby conducing the conditioning modulation of pain perception (CPM) by said subject.

20. The method as in claim 19, further comprises determining a subjective pain threshold level of said patient.

21. The method as in claim 19, wherein said therapeutic CPM stimulation is delivered at sub-threshold pain level relatively subjective pain threshold level of said patient.

22. The method as in claim 19, wherein said selecting at least one location suitable for the delivery of a therapeutic CPM stimulation, comprises:

[a] determining a respective dermatome/s accosted with a localized pain;

[b] preselecting in accordance with said DNIC paradigm a plurality of dermatomes, application of stimulation to which is putatively to conduce a CPM effect;

[c] selecting from said plurality of preselected dermatomes at least one dermatome overlaying a site that physically/anatomically facilitates an efficient application of said CPM stimulation and/or implantation of an electrical electrode therefor.

23. The method as in claim 19, wherein said selecting at least one location suitable for the delivery of a therapeutic CPM stimulation, comprises:

[a] diagnosing said patient for a non-localized pain;

[b] arbitrarily selecting at least one dermatome;

[c] applying a therapeutic CPM stimulation to said dermatome;

[d] empirically evaluating the conduced CPM effect;

[e] preselecting, in accordance with said DNIC paradigm and based upon said empirical evaluation, a plurality of dermatomes, application of stimulation to which is putatively to conduce a CPM effect, and

[f] selecting from said plurality of preselected dermatomes at least one dermatome overlaying a site that physically/anatomically facilitates an efficient application of said CPM stimulation and/or implantation of an electrical electrode therefor.

24. The method as in claim 19, wherein said pain is an idiopathic or neuropathic pain.

25. The method as in claim 19, wherein the indication for said therapeutic CPM stimulation is selected from the group consisting of:

a diabetic neuropathy, uremic neuropathy, post herpetic neuralgia, post operative neuropathic pain, traumatic nerve lesions, chemotherapy in general and chemotherapy by vincristine, taxol, platinot, thalidomide, hereditary neuropathy, pesticide induced neuropathy, post-operative pains, fibromyalgia, temporomandibular diorders, irritable bowel syndrome, tension type headache, atypical facial pain, migraine, vulvar vestibulitis and low back pains.

26. The method as in claim 19, wherein said therapeutic CPM stimulation is delivered percutaneously.

27. The method as in claim 19, wherein said therapeutic CPM stimulation is delivered subcutaneously.