Stimulation method for the dural venous sinuses and adjacent dura for treatment of medical conditions

• US 6,405,079 B1
• Filed: 09/22/2000
• Issued: 06/11/2002
• Est. Priority Date: 09/22/2000
• Status: Active Grant

• Current Assignee: Ansarinia, Mehdi M.
• Original Assignee: Ansarinia, Mehdi M.
• Inventors: Ansarinia, Mehdi M.
• Primary Examiner(s): Getzow, Scott M.
• Application Number:
  US09/667,868
• Time in Patent Office: 627 Days
• Field of Search: 607/2, 607/3, 607/44, 607/45, 607/46, 128/898
• US Class Current: 607/2
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A method is provided for the suppression or prevention of pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, urinary bladder disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient. The method comprises positioning at least one electrode adjacent to or around an implantation site selected from the group consisting of the patient'"'"'s: superior sagittal sinus; confluence of sinuses; occipital sinus; sigmoid sinus; transverse sinus; straight sinus; inferior sagittal sinus; the dura adjacent the superior sagittal sinus, confluence of sinuses, occipital sinus, sigmoid sinus, transverse sinus, straight sinus, or inferior sagittal sinus; or falx cerebri. The electrode is then activated to apply an electrical signal to the at least one implantation site. In a further embodiment of the invention used to treat the same conditions, the electrode dispenses a medication solution or analgesic to the implantation site. A method is also provided for surgically implanting the electrodes adjacent to or around the implantation site.

Claims

1. A method for suppressing or preventing pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, urinary bladder disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient, the method comprising:

positioning at least one electrode adjacent to or around at least one implantation site, said at least one implantation site selected from the group consisting of the patient'"'"'s;

superior sagittal sinus;

confluence of sinuses;

occipital sinus;

sigmoid sinus;

transverse sinus;

straight sinus;

inferior sagittal sinus;

the dura adjacent the superior sagittal sinus, confluence of sinuses, occipital sinus, sigmoid sinus, transverse sinus, straight sinus, or inferior sagittal sinus;

or falx cerebri;

activating the at least one electrode to apply an electrical signal to the at least one implantation site.

2. The method of claim 1 wherein the at least one electrode is surgically implanted adjacent to or around the at least one implantation site.

3. The method of claim 2 wherein the electrical signal applied by the electrode can be adjusted in voltage, frequency, pulse width, current, or intensity.

4. The method of claim 3 wherein the electrical signal applied by the electrode may be made positive or negative and the direction of current flow from the electrode may be changed.

5. The method of claim 4 wherein the at least one electrode may be remotely controlled using a remote control device which is accessible from outside the body of the patient.

6. The method of claim 5 wherein the at least one electrode is powered by a power source surgically implanted within the patient.

7. The method of claim 6 wherein the at least one electrode is multi-polar.

8. The method of claim 6 wherein the at least one electrode is unipolar.

9. The method of claim 6 wherein the at least one electrode is bipolar.

10. The method of claim 7 wherein the electrical signal applied by the at least one electrode has a frequency in the range of from about 0.1 to 2500 Hertz, a pulse width in the range of from about 20 to 1500 microseconds, an amplitude in the range of from about 0.1 to 50 volts, and an amplitude in the range of from about 0.1 to 50 milliamperes.

11. The method of claim 1 wherein activation of the at least one electrode is done to treat:

(i) pain resulting from one or more medical conditions comprising;

migraine headaches, including migraine headaches with aura, migraine headaches without aura, menstrual migraines, migraine variants, atypical migraines, complicated migraines, hemiplegic migraines, transformed migraines, and chronic daily migraines;

episodic tension headaches;

chronic tension headaches;

analgesic rebound headaches;

episodic cluster headaches;

chronic cluster headaches;

cluster variants;

chronic paroxysmal hemicrania;

hemicrania continua;

post-traumatic headache;

post-traumatic neck pain;

post-herpetic neuralgia involving the head or face;

pain from spine fracture secondary to osteoporosis;

arthritis pain in the spine, headache related to cerebrovascular disease and stroke;

headache due to vascular disorder;

musculoskeletal neck pain;

reflex sympathetic dystrophy, cervicalgia;

glossodynia, carotidynia;

cricoidynia;

otalgia due to middle ear lesion;

gastric pain;

sciatica;

maxillary neuralgia;

laryngeal pain, myalgia of neck muscles;

trigeminal neuralgia;

post-lumbar puncture headache;

low cerebro-spinal fluid pressure headache;

temporomandibular joint disorder;

atypical facial pain;

ciliary neuralgia;

paratrigeminal neuralgia;

petrosal neuralgia;

Eagle'"'"'s syndrome;

idiopathic intracranial hypertension;

orofacial pain;

myofascial pain syndrome involving the head, neck, and shoulder;

chronic migraneous neuralgia, cervical headache;

paratrigeminal paralysis;

sphenopalatine ganglion neuralgia;

carotidynia;

Vidian neuralgia; and

causalgia;

(ii) movement disorders resulting from one or more medical conditions comprising;

Parkinson'"'"'s disease;

cerebral palsy;

dystonia;

essential tremor; and

hemifacial spasms;

(iii) epilepsy, including generalized and partial seizure disorder;

(iv) cerebrovascular diseases resulting from one or more medical conditions comprising;

atherosclerosis, aneurysms, strokes, and cerebral hemorrhage;

(v) autoimmune diseases resulting from one or more medical conditions comprising multiple sclerosis;

(vi) sleep disorders resulting from one or more medical conditions comprising sleep apnea and parasomnias;

(vii) autonomic disorders resulting from one or more medical conditions comprising;

gastrointestinal disorders, including but not limited to gastrointestinal motility disorders, nausea, vomiting, diarrhea, chronic hiccups, gastroesphageal reflux disease, and hypersecretion of gastric acid;

autonomic insufficiency;

excessive epiphoresis;

excessive rhinorrhea; and

cardiovascular disorders including but not limited to cardiac dysrythmias and arrythmias, hypertension, and carotid sinus disease;

(viii) urinary bladder disorders resulting from one or more medical conditions comprising spastic or flaccid bladder;

(ix) abnormal metabolic states resulting from one or more medical conditions comprising hyperthyroidism or hypothyroidism

(x) disorders of the muscular system resulting from one or more medical conditions comprising muscular dystrophy and spasms of the upper respiratory tract and face; and

(xi) neuropsychiatric disorders resulting from one or more medical conditions comprising;

depression, schizophrenia, bipolar disorder, autism, personality disorders, and obsessive-compulsive disorder.

12. A method for suppressing or preventing pain, movement disorders, epilepsy, cerebrovascular diseases, autoimmune diseases, sleep disorders, autonomic disorders, urinary bladder disorders, abnormal metabolic states, disorders of the muscular system, and neuropsychiatric disorders in a patient, the method comprising:

positioning at least one electrode adjacent to or around at least one implantation site, said at least one implantation site selected from the group consisting of the patient'"'"'s;

superior sagittal sinus;

confluence of sinuses;

occipital sinus;

sigmoid sinus;

transverse sinus;

straight sinus;

inferior sagittal sinus;

the dura adjacent the superior sagittal sinus, confluence of sinuses, occipital sinus, sigmoid sinus, transverse sinus, straight sinus, or inferior sagittal sinus;

or falx cerebri;

said electrode capable of dispensing a medication solution or an analgesic;

activating the at least one electrode to apply the medication solution or analgesic to said at least one implantation site.

13. The method of claim 12 wherein the at least one electrode is surgically implanted adjacent to or around said at least one implantation site.

14. The method of claim 13 wherein the amount of medication solution or analgesic applied, the rate at which medication solution or analgesic is applied, and the time period over which the medication solution or analgesic is applied can be adjusted.

15. The method of claim 14 wherein the at least one electrode may be remotely controlled using a remote control device which is accessible from outside the body of the patient.

16. The method of claim 15 wherein the at least one electrode is powered by a power source surgically implanted within the patient.

17. The method of claim 12 wherein activation of the at least one electrode is done to treat:

(i) pain resulting from one or more medical conditions comprising;

migraine headaches, including migraine headaches with aura, migraine headaches without aura, menstrual migraines, migraine variants, atypical migraines, complicated migraines, hemiplegic migraines, transformed migraines, and chronic daily migraines;

episodic tension headaches;

chronic tension headaches;

analgesic rebound headaches;

episodic cluster headaches;

chronic cluster headaches;

cluster variants;

chronic paroxysmal hemicrania;

hemicrania continua;

post-traumatic headache;

post-traumatic neck pain;

post-herpetic neuralgia involving the head or face;

pain from spine fracture secondary to osteoporosis;

arthritis pain in the spine, headache related to cerebrovascular disease and stroke;

headache due to vascular disorder;

reflex sympathetic dystrophy, cervicalgia;

glossodynia, carotidynia;

cricoidynia;

otalgia due to middle ear lesion;

gastric pain;

sciatica;

maxillary neuralgia;

laryngeal pain, myalgia of neck muscles;

trigeminal neuralgia;

post-lumbar puncture headache;

low cerebro-spinal fluid pressure headache;

temporomandibular joint disorder;

atypical facial pain;

ciliary neuralgia;

paratrigeminal neuralgia;

petrosal neuralgia;

Eagle'"'"'s syndrome;

idiopathic, intracranial hypertension;

orofacial pain;

myofascial pain syndrome involving the head, neck, and shoulder;

chronic migraneous neuralgia, cervical headache;

paratrigeminal paralysis;

sphenopalatine ganglion neuralgia;

carotidynia;

Vidian neuralgia; and

causalgia;

(ii) movement disorders resulting from one or more medical conditions comprising;

Parkinson'"'"'s disease;

cerebral palsy;

dystonia;

essential tremor; and

hemifacial spasms;

(iii) epilepsy, including generalized and partial seizure disorder;

(iv) cerebrovascular diseases resulting from one or more medical conditions comprising;

atherosclerosis, aneurysms, strokes, and cerebral hemorrhage;

(v) autoimmune diseases resulting from one or more medical conditions comprising multiple sclerosis;

(vi) sleep disorders resulting from one or more medical conditions comprising sleep apnea and parasomnias;

(vii) autonomic disorders resulting from one or more medical conditions comprising;

gastrointestinal disorders, including but not limited to gastrointestinal motility disorders, nausea, vomiting, diarrhea, chronic hiccups, gastroesphageal reflux disease, and hypersecretion of gastric acid;

autonomic insufficiency;

excessive epiphoresis;

excessive rhinorrhea; and

cardiovascular disorders including but not limited to cardiac dysrythmias and arrythmias, hypertension, and carotid sinus disease;

(viii) urinary bladder disorders resulting from one or more medical conditions comprising spastic or flaccid bladder;

(ix) abnormal metabolic states resulting from one or more medical conditions comprising hyperthyroidism or hypothyroidism

(x) disorders of the muscular system resulting from one or more medical conditions comprising muscular dystrophy and spasms of the upper respiratory tract and face; and

(xi) neuropsychiatric disorders resulting from one or more medical conditions comprising;

depression, schizophrenia, bipolar disorder, autism, personality disorders, and obsessive-compulsive disorder.

18. A method for surgically implanting an electrode adjacent to or around at least one implantation site, said at least one implantation site selected from the group consisting of the patient'"'"'s:

superior sagittal sinus;

confluence of sinuses;

occipital sinus;

sigmoid sinus;

transverse sinus;

straight sinus;

inferior sagittal sinus;

the dura adjacent the superior sagittal sinus, confluence of sinuses, occipital sinus, sigmoid sinus, transverse sinus, straight sinus, or inferior sagittal sinus;

or falx cerebri;

the method comprising;

surgically opening an entry to the at least one implantation site;

positioning and implanting an electrode adjacent to or around the at least one implantation site; and

surgically closing the implantation site.

19. The method of claim 18 further comprising the step of attaching said electrode to an external power source.

20. The method of claim 18 wherein said electrode contains its own power source.

21. The method of claim 18 wherein said step of surgically opening an entry to the at least one implantation site comprises performing a craniotomy removing a portion of the cranium above the implantation site.

22. The method of claim 18 wherein said step of surgically opening an entry to the at least one implantation site comprises making one or more burr holes in the patient'"'"'s skull such that an electrode may be passed through said one or more burr holes and positioned at the implantation site.