OCCIPITAL NEUROMODULATION

• US 20100069993A1
• Filed: 09/16/2008
• Published: 03/18/2010
• Est. Priority Date: 09/16/2008
• Status: Active Grant

• Current Assignee: The King of Shaves Company Ltd
• Original Assignee: The King of Shaves Company Ltd
• Inventors: Greenspan, Joshua
• Granted Patent: US 8,280,515 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36025 for treating a mental or cerebral condition
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36082 Cognitive or psychiatric applications, e.g. dementia or Alzheimer's disease
• CPC Class Codes: A61N 1/36157 Current A61N1/3616 takes precedence
• CPC Class Codes: A61N 1/36171 Frequency
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle

Abstract

A method of treating chronic pain in a subject by positioning a lead containing electrodes subcutaneously in the occipital region of a subject'"'"'s skull at the height of an imaginary line connecting the tops of the ears; and energizing the lead with an electrical signal effective to suppress pain, and below the level where the subject can feel the lead being energized. Typically the procedure involves a trial phase and a permanent implant phase. The procedure is known as occipital neuromodulation.

Claims

1. A method of treating pain in a subject comprising the steps of:

positioning a lead subcutaneously in the Occipital region of a subject'"'"'s skull at the height of an imaginary line connecting the tops of the subject'"'"'s ears; and

energizing the lead with an electrical signal effective to suppress pain, and below the level where the subject can feel the lead being energized.

2. The method of claim 1, wherein the level where the subject can feel the lead being energized is the onset of paresthesia.

3. The method of claim 1, wherein the pain is chronic pain.

4. The method of claim 1, wherein the pain is one selected from the group consisting of migraine, fibromyalgia, neuropathic pain, and traumatic brain injury.

5. The method of claim 1 wherein the energizing step includes energizing with an electrical signal comprising:

amplitude between 0.1 mA and 8 mA;

frequency of 6, 12, 18, or 24 Hz; and

pulse width between 50 msec and 100 msec.

6. The method of claim 5, further comprising the step of providing a pulse generator capable of providing an electrical signal comprising an amplitude between 0.1 mA and 8 mA;

frequency of 6, 12, 18, or 24 Hz; and

pulse width between 50 ms and 100 ms.

7. A method of treating chronic pain in a subject comprising the steps of conducting a a) trial phase followed by a b) permanent implant, the a) trial phase comprising the steps of:

positioning a tip of two leads subcutaneously in the occipital region of a subject'"'"'s scalp with the remainder of the leads remaining outside the subject'"'"'s skin; and

coupling a programmer to the temporary leads outside the subjects'"'"' skin, the programmer being capable of producing electrical signal comprising amplitude between 0.1 mA and 8 mA;

frequency of 6, 12, 18, 24 Hz; and

pulse width between 50 msec and 100 msec;

thereby enabling the subject to adjust the electrical signal to a level such that the subject experiences a decrease in pain over time although not being able to feel the lead being energized.

8. The method of claim 7, further comprising the step of energizing the lead with an electrical signal comprising amplitude between 0.1 mA and 8 mA;

frequency of 6, 12, 18, 24 Hz; and

pulse width between 50 msec and 100 msec.

9. The method of claim 7, the b) permanent implant comprising the steps of:

implanting two pairs of permanent leads subcutaneously in the occipital region of a subject'"'"'s scalp parallel to each;

implanting the internal pulse generator subcutaneously; and

coupling the permanent leads to the internal pulse generator.

10. The method of claim 9, further comprising the step of energizing the leads with an electrical signal comprising amplitude between 0.1 mA and 8 mA;

frequency of 6, 12, 18, 24 Hz; and

pulse width between 50 msec and 100 msec.

11. The method of claim 10 further comprising the step of providing an external programmer for controlling the internal pulse generator.

12. The method of claim 11 further comprising the step of decreasing the energizing with the external programmer to a signal effective to suppress pain and below a level where the subject can feel the lead being energized.

13. A kit for treating pain comprising:

a pair of leads;

a pulse generator capable of energizing the leads with an electrical signal comprising amplitude between 0.1 mA and 8 mA;

frequency of 6, 12, 18, 24 Hz; and

pulse width between 50 msec and 100 msec; and

instructions for programming the pulse generator to generate an electrical signal effective to treat pain, and below the level where the subject can feel the lead being energized.

14. A method for determining whether pain can be treated by anatomical correction or not in a subject comprising the steps of:

positioning an lead subcutaneously in the occipital region of a subject'"'"'s scalp;

energizing the lead with an electrical signal; and

determining that pain can be treated by anatomical correction if the pain cannot be eliminated by the energizing.

15. A method of treating a plurality of chronic pain disorders in a subject comprising the steps of:

positioning an electrode subcutaneously at an occipital region of a subject'"'"'s skull; and

energizing the electrode with an electrical signal sufficient to suppress a chronic pain disorder, and below the level where the subject can feel the electrode being energized.