Peripheral nerve stimulation

• US 8,774,924 B2
• Filed: 03/17/2006
• Issued: 07/08/2014
• Est. Priority Date: 05/29/1999
• Status: Active Grant

• Current Assignee: Richard L Weiner
• Original Assignee: Richard L Weiner
• Inventors: Weiner, Richard L.
• Primary Examiner(s): EVANISKO, GEORGE ROBERT
• Application Number:
  US11/378,094
• Publication Number:
  US 20060206166A1
• Time in Patent Office: 3,035 Days
• Field of Search: 607/46, 607/116, 607/117
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

An apparatus for treating pain by electrical stimulation is disclosed. A lead is placed subcutaneously in the region of pain. The subcutaneous tissue is electrically stimulated to cause paresthesia. The method encompasses subcutaneous placement of an electrical lead near the region of pain and subsequent electrical stimulation of the tissue to cause paresthesia. In particular, an apparatus for treating intractable occipital neuralgia using percutaneous electrostimulation techniques is disclosed.

Claims

1. A method of stimulating to treat pain emanating from at least one peripheral nerve of a patient, the method comprising:

percutaneously placing with a tubular introducer at least one electrode in subcutaneous tissue entirely superficial to the fascia and muscle layer, but below the skin, without further dissection, across a trunk of the peripheral nerve that is causing pain, applying electrical stimulation of a predetermined level to the at least one peripheral nerve with the at least one entire electrode in the subcutaneous tissue to cause paresthesia of the painful area, said at least one electrode being sufficiently distant from the at least one peripheral nerve to preclude either a burning sensation or muscular contractions noticeable by the patient when applying said electrical stimulation.

2. The method of claim 1, further comprising palpating the area of pain prior to percutaneously placing the at least one electrode in the subcutaneous tissue to identify the specific peripheral nerve that is causing the pain.

3. The method of claim 1, wherein the step of percutaneously placing with a tubular introducer at least one electrode comprises providing an introducer needle;

and placing the introducer needle in the subcutaneous tissue so as to be entirely superficial to and across the peripheral nerve that is causing pain routing an electrical lead with the electrode through the tubular introducer; and

removing the introducer leaving the lead in place in the subcutaneous tissue.

4. The method of claim 3, wherein the step of placing the tubular introducer comprises curving the tubular introducer so that the tubular introducer conforms to a contour of the subcutaneous tissue in the patient'"'"'s body superficial to the fascia.

5. The method of claim 1, wherein the lead is a first lead and the step of placing at least one electrode further comprises placing a second lead having a second at least one electrode in subcutaneous tissue located entirely superficial to the fascia and muscle layer but below the skin and sufficiently distant from the peripheral nerve that is causing pain so that the step of providing electrical stimulation of a predetermined level to the at least one peripheral nerve with the second at least one electrode will cause paresthesia of the painful area without causing either a burning sensation or muscular contractions noticeable by the patient when applying said electrical stimulation.

6. The method of claim 1, wherein the lead is a dual lead.

7. The method of claim 1, further comprising connecting the at least one electrode to a screening device.

8. The method of claim 7, further comprising performing test electrical stimulation with the at least one electrode.

9. The method of claim 8, wherein the step of performing comprises electrically stimulating the patient with the at least one electrode and screener device;

and evaluating the effectiveness of the placement of the at least one electrode based on the patient'"'"'s response to the electrical stimulation.

10. The method of claim 8, further comprising implanting a neurostitnulator;

and electrically connecting the neurostimulator to the at least one electrode.

11. The method of claim 1, wherein the peripheral nerve is selected from the group consisting of a supraorbital nerve, a clunial nerve, an iliolinguinal nerve, a median nerve, an ulnar nerve and a sciatic nerve.

12. The method of claim 1, wherein percutaneously placing of the at least one electrode comprises:

first percutaneously placing with a tubular introducer a screening lead having the at least one electrode in subcutaneous tissue superficial to the fascia and muscle layer but below the skin, the screening lead'"'"'s electrode being entirely superficial to and sufficiently distant from the peripheral nerve causing pain so that the at least one electrode of the screening lead is in the subcutaneous tissue;

electrically energizing the at least one electrode on the screening lead with pulses sufficient to cause stimulated paresthesia of the painful area;

determining whether the pulses also produce a burning sensation or muscular contractions noticeable by the patient and if not, replacing the screening lead with a permanent lead having at least one electrode thereof at the position previously occupied by the at least one electrode of the screening lead where energizing of the at least one electrode on the screening lead resulted in paresthesia of the nerve causing pain without an attendant burning sensation or muscular contraction.

13. A method of stimulating an occipital nerve to treat occipital neuralgia, the method comprising:

(a) percutaneously placing with an introducer needle at least one electrode in subcutaneous tissue entirely superficial to the fascia and muscle layer, but below the skin, without further dissection, across a trunk of the occipital nerve that is causing pain;

applying pulse energy to the at least one electrode; and

determining from the patient whether stimulated paresthesia of the painful area has occurred without an attendant burning sensation or muscular contractions noticeable by the patient upon application of the pulse energy.

14. The method of claim 13, comprising percutaneously placing a lead comprising the at least one electrode at a level of C1 transversely across a base of the occipital nerve trunk.

15. The method of claim 13, wherein percutaneously placing at least one electrode comprises placing an introducer needle in the subcutaneous tissue superficial to the peripheral nerve that is causing pain;

passing the at least one electrode through the introducer needle until the at least one electrode is in position in the subcutaneous tissue superficial to the fascia and muscle layer but below the skin and to the peripheral nerve causing pain and removing the introducer needle without displacing the at least one electrode.

16. The method of claim 13, further comprising palpating the area of pain prior to placing the lead to identify the specific occipital nerve that is causing the pain.

17. The method of claim 13, further comprising connecting the at least one electrode to a screening device.

18. The method of claim 17, further comprising performing test electrical stimulation with the at least one electrode.

19. The method of claim 18, wherein the step of performing test electrical stimulation comprises electrically stimulating the patient with the at least one electrode and screening device;

and evaluating the position of the at least one electrode based on the patient'"'"'s response to the electrical stimulation.

20. The method of claim 18, further comprising implanting a neurostimulator;

and electrically connecting the neurostimulator to the at least one electrode.

21. A method of stimulating at least one peripheral nerve to treat neuralgias emanating from the at least one peripheral nerve, the method comprising:

(a) percutaneously placing through an introducer needle at least one electrode in a patient'"'"'s subcutaneous tissue at a location entirely superficial to the fascia and muscle layer, but below the skin, without further dissection, across a trunk of the at least one peripheral nerve that is causing pain, providing electrical stimulation to the at least one peripheral nerve with the at least one electrode in the subcutaneous tissue, determining from the patient whether paresthesia of the painful area has resulted without an attendant burning sensation or muscular contractions noticeable by the patient when applying the electrical stimulation.

22. The method of claim 21, wherein the neuralgias is selected from the group consisting of post herpetic neuralgia, chronic deafferentation pain, chronic peripheral nerve pain, post craniotomy pain, incisional pain, clunial nerve pain, post hemiorrhapy pain, localized low back pain or other spine pain, incisional neuroma pain, stump neuroma pain, incisional scar pain, deafferentation pain, chronic peripheral nerve pain, sciatic neuralgia, medial neuralgia and ulnar neuralgia.

23. A method of treating head pain comprising percutaneously placing at least one electrode in the subcutaneous tissue such that it is entirely superficial to muscle and fascia layers but below the skin, without further dissection across a trunk of a nerve, and a predetermined distance from the nerve located adjacent a part of a skull causing head pain;

providing pulses of an electrical current to the at least one electrode;

determining from the patient whether a sensation of head pain is reduced without causing either a burning sensation or muscular contractions noticeable by the patient, and adjusting the predetermined distance and the electrical current pulses until the head pain is reduced without an attendant burning sensation or muscle contraction upon application of the electrical current pulses.

24. The method of claim 23, wherein the head pain is selected from the group consisting of cervicogenic headache and occipital head pain.

25. The method of claim 23, wherein providing the electrical current pulses causes paresthesia near the location of the nerve.

26. The method of claim 23, wherein the at least one electrode comprises an array of electrodes.

27. A method of treating pain in an area of the body of a patient, the method comprising identifying an area of pain innervated by at least one peripheral nerve, and percutaneously implanting a lead having a plurality of electrodes through a needle introducer such that said electrodes are placed in a patient'"'"'s subcutaneous tissue in the area entirely superficial to the fascia and muscle layer, but below the skin, without further dissection, across a trunk of the at least one peripheral nerve applying electrical pulses to at least one electrode of the plurality of electrodes to supply electrical stimulation of a level effective to cause paresthesia of the area without an attendant burning sensation or muscular contractions noticeable by the patient when supplying the electrical stimulation.

28. The method of claim 27 wherein the lead is a quadripolar lead.

29. The method of claim 27 wherein the lead is an octapolar lead.

30. A method of treating pain, the method comprising:

identifying at least two areas of pain innervated by peripheral nerves, percutaneously implanting a first lead having at least one electrode such that each electrode of the first lead is placed in a patient'"'"'s subcutaneous tissue in a first area of pain so as to be entirely superficial to the fascia and muscle layer, but beneath the skin, without further dissection, across a trunk of a peripheral nerve innervating the first area providing electrical stimulation of a predetermined level to the first area using the at least one electrode on the first lead to disrupt pain in the first area and not cause either a burning sensation or muscular contractions noticeable by the patient; and

percutaneously implanting a second lead having at least one electrode such that each electrode of the second lead is placed in the subcutaneous tissue in a second area of pain each electrode of the second lead being entirely superficial to the fascia and muscle layer, but beneath the skin, without further dissection, across a trunk of a peripheral nerve innervating the second area such that providing electrical stimulation of a predetermined level to the second area using the at least one electrode on the second lead is effective to disrupt pain in the second area while not causing either a burning sensation or muscular contractions noticeable by the patient.

31. The method of claim 30 wherein said pain is bilateral pain.

32. A method of treating pain in an area of the body, the method comprising:

identifying an area of pain innervated by at least one peripheral nerve, percutaneously implanting a lead having a plurality of electrodes such that said electrodes are placed in a patient'"'"'s subcutaneous tissue in the area so as to be entirely superficial to the muscle and fascia layers covering the at least one peripheral nerve, without further dissection across a trunk of the peripheral nerves, across a trunk of said peripheral nerve, and using at least one electrode of the plurality of electrodes to supply electrical stimulation of a level sufficient to cause paresthesia of the area, without attendant burning sensation or muscular contractions noticeable by the patient when applying the electrical stimulation.

33. A method of treating pain using electrical stimulation, the method comprising:

identifying at least two areas of pain innervated by peripheral nerves, implanting a first lead having at least one electrode such that each electrode of the first lead is placed in a patient'"'"'s subcutaneous tissue in a first area of pain without further dissection so as to be entirely superficial to the fascia and muscle layers covering the peripheral nerves innervating the first area;

percutaneously implanting a second lead having at least one electrode such that each electrode of the second lead is placed in the subcutaneous tissue in a second area of pain without further dissection so as to be entirely superficial to the fascia and muscle layers covering the peripheral nerves innervating the second area; and

supplying electrical stimulation to at least one electrode of the first lead and to at least one electrode of the second lead of a level sufficient to cause paresthesia disrupting the pain, wherein each of the electrodes to which such electrical stimulation is supplied is at a location which will not cause either a burning sensation or muscular contractions noticeable by the patient when the electrical stimulation is supplied.

34. A method of treating pain in an area of the body, the method comprising:

identifying nerves causing the pain, percutaneously implanting a lead having a plurality of electrodes through a tubular introducer such that said electrodes are placed below the skin and entirely in subcutaneous tissue superficial to the fascia and muscle layers covering the identified nerves without further dissection across a trunk of said identified nerves; and

providing electrical stimulation to the identified nerves with at least some of the plurality of electrodes sufficient to cause paresthesia of the painful area without causing an attendant burning sensation or muscular contractions noticeable by the patient when the electrical stimulation is applied.