Claims for Patent: 7,328,069

Summary for Patent: 7,328,069

Title:	Method, system and device for treating disorders of the pelvic floor by electrical stimulation of and the delivery of drugs to the left and right pudendal nerves
Abstract:	Described are devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal nerves, and means for delivering one or more drugs in association with such electrical stimulation therapies. One or more electrical stimulation signals are applied, and one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient\'s pelvic floor and the pudendal nerves or portions thereof in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary voiding dysfunction, fecal voiding dysfunction, constipation, stress incontinence, urge incontinence, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.
Inventor(s):	Gerber; Martin T. (Maple Grove, MN)
Assignee:	Medtronic, Inc. (Minneapolis, MN)
Application Number:	10/836,970
Patent Claims:	1. A method of treating at least one diagnosed pelvic floor disorder in a patient, the at least one disorder being selected from the group consisting of constipation, prostatitis, prostatalgia and prostatodynia, the method comprising: implanting a distal end of a first implantable medical electrical lead in a first tissue volume of the patient adjacent, around or in one of a right pudendal nerve or branches or portions thereof, a left pudendal nerve or branches or portions thereof, a right sacral nerve or branches or portions thereof, or a left sacral nerve or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least a first electrical stimulation pulse regime via at least the first lead; implanting the implantable pulse generator within the patient; implanting a distal end of an implantable drug catheter in one of the first tissue volume or a second tissue volume of the patient adjacent, around or in one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof; implanting an hermetically sealed implantable drug pump within the patient, the implantable drug pump configured to receive and house a volume of a drug therewithin, and to deliver a such drug to an exterior thereof via the implantable drug catheter; operably connecting a proximal end of the implantable drug catheter to the implantable drug pump; delivering, from the implantable pulse generator, first electrical stimulation pulses to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof through the first lead and at least the first electrode, the first pulses being provided in accordance with the first electrical stimulation pulse regime; and delivering from the implantable drug pump a predetermined portion of the drug housed therewithin to the exterior thereof through the implantable drug catheter and to the distal end thereof to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof; wherein the combination of the first electrical pulse regime and the predetermined amount of the drug is delivered in a configuration effective to provide at least partial relief from at least one of constipation, prostatitis, prostatalgia and prostatodynia. 2. The method of claim 1, wherein the first lead comprises a beam steering lead comprising multiple electrodes. 3. The method of claim 1, wherein the implantable pulse generator and the first lead are capable of generating and delivering electrical pulses having frequencies ranging between about 50 Hz and about 100 Hz, between about 10 Hz and about 250 Hz, or between about 0.5 Hz and about 500 Hz. 4. The method of claim 1, wherein the implantable pulse generator and the first lead are capable of generating and delivering electrical pulses having amplitudes ranging between about 1 Volt and about 10 Volts, between about 0.5 Volts and about 20 Volts, or between about 0.1 Volts and about 50 Volts. 5. The method of claim 1, wherein the implantable pulse generator and at the first lead are capable of generating and delivering electrical pulses having pulse widths ranging between about 180 microseconds and about 450 microseconds, between about 100 microseconds and about 1000 microseconds, or between about 10 microseconds and about 5000 microseconds. 6. The method of claim 1, wherein delivering first electrical stimulation pulses comprises: generating a plurality of different electrical signals, electrical pulses of the electrical signals having respective spatial or temporal phases; and delivering the pulses to one of the right pudendal nerve or branch or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof. 7. The method of claim 1, wherein at least one of activation, modification and termination of the first pulse regime is carried out by the patient or a health care giver. 8. The method of claim 7, wherein the at least one of activation, modification and termination of the first pulse regime is carried out in response to patient symptoms appearing or disappearing, or the patient feeling or not feeling symptoms. 9. The method of claim 7, wherein patient or health care giver activation, modification and/or termination of the first pulse regime is accomplished though infra-red, telemetric, radio, magnetic, or ultrasonic means. 10. The method of claim 1, wherein the first pulse regime is delivered in response to a sensed physical parameter or symptom. 11. The method of claim 1, wherein the first pulse regime is one of activated, modified and terminated in response to a physical parameter or symptom being sensed. 12. The method of claim 11, wherein the physical parameter is sensed using a nerve electrical signal sensor. 13. The method of claim 1, wherein the drug pump is a peristaltic drug pump. 14. The method of claim 1, wherein the implantable drug pump and the implantable pulse generator are disposed within a single hermetically sealed housing. 15. The method of claim 1, wherein the portion of the drug is delivered to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof at a predetermined relatively constant rate. 16. The method of claim 1, wherein the portion of the drug is delivered to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches portions thereof, or the left sacral nerve or branches or portions thereof at predetermined intervals. 17. The method of claim 1, wherein the drug catheter is structurally combined with the first lead. 18. The method of claim 1, wherein the drug is selected from the group consisting of anticholinergic drugs, antidepressant drugs, motor neuron suppression drugs, sensory desensitization drugs, anti-inflammatory drugs, pain relief drugs and hormone drugs. 19. The method of claim 1, wherein the drug is selected from the group consisting of tolterodine, hyoscyamine, imipramine, baclofen, resiniferatoxin, dimethyl sulfoxide, bacillus Calmette-Guerin (BCG) and estrogen. 20. The method of claim 1, wherein the drug is selected from the group consisting of and estrogen. 21. The method of claim 1, wherein the drug is selected from the group consisting of an antibiotic, an analgesic, a tricyclic antidepressant, a muscle relaxant, a smooth muscle relaxant, and a hormone replacement. 22. The method of claim 1, wherein the drug is selected from the group consisting of flouroquinolone, trimethoprimsulfamethoxazole, aspirin, acetaminophen, phenazopyridine, opioids, meperidine, hydromorphone, methandone, levorphanol and morphine. 23. The method of claim 1, wherein the drug is selected from the group consisting of glucosamine, chondroitin, quercetin, a combination of chondroitin and quercetin, hyaluronic acid, pentosan polysulfate sodium, heparin sodium, amitriptyline, deipramine, nortriptyline, doxepin, impramine, hyoscyamine, oxybutynin chloride, cyclobenzprine, hyoscyamine sulfate, tolterodine tartrate and resiniferatoxin. 24. The method of claim 1, wherein the drug comprises a motility stimulation agent. 25. The method of claim 1, wherein the drug is selected from the group consisting of tagaserod, cisapride, erythomycin, and caffeine. 26. The method of claim 1, further comprising: configuring and providing the hermetically sealed implantable electrical pulse generator so as to provide a second electrical stimulation pulse regime via a second implantable medical electrical lead. 27. The method of claim 26, further comprising: providing the second implantable medical electrical lead, the second lead comprising proximal and distal ends and at least a second electrode. 28. The method of claim 27, further comprising: implanting the second lead in the second tissue volume of the patient adjacent, around or in one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof; operably connecting the proximal end of the second lead to the implantable pulse generator; and delivering, from the implantable pulse generator, second electrical stimulation pulses to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof through the second lead and at least the second electrode, the second pulses being provided in accordance with the second electrical stimulation pulse regime; wherein the combination of the first and the second electrical pulse regimes delivered, and the predetermined amount of the drug is delivered in a configuration effective to provide at least partial relief from at least one of constipation, prostatitis, prostatalgia and prostatodynia. 29. The method of claim 28, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to the pudendal nerves the sacral nerves, and delivering second electrical stimulation pulses comprises delivering the second electrical stimulation pulses to the other of the pudendal nerves or the sacral nerves. 30. The method of claim 28, wherein the first and second tissue volumes are located in respective ones of right and left sides of the patient. 31. The method of claim 1, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to the pudendal nerves or branches or portions thereof. 32. The method of claim 1, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to the sacral nerves or branches or portions thereof. 33. The method of claim 1, wherein implanting the implantable drug catheter comprises implanting the catheter in the second tissue volume, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to one of the pudendal nerves or one of the sacral nerves, and delivering a predetermined portion of the drug comprises delivering the predetermined portion of the drug to the other of the pudendal nerves or the sacral nerves. 34. The method of claim 1, wherein implanting the implantable drug catheter comprises implanting the catheter in the second tissue volume, wherein the first and second tissue volumes are located in respective ones of right and left sides of the patient. 35. The method of claim 1, wherein delivering, from the implantable pulse generator, first electrical stimulation pulses comprises delivering stimulation pulses at a frequency greater than approximately 50 Hz. 36. A method of treating at least one diagnosed pelvic floor disorder in a patient, the at least one disorder being selected from the group consisting of constipation, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, prostatitis, prostatalgia and prostatodynia, the method comprising: implanting a distal end of at least a first implantable medical electrical lead in a first tissue volume of the patient adjacent, around or in one of a right pudendal nerve or branches or portions thereof or a left pudendal nerve or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least a first electrical stimulation pulse regime via at least the first lead; implanting the implantable pulse generator within the patient; implanting a distal end of an implantable drug catheter in one of the first tissue volume or a second tissue volume of the patient adjacent, around or in one of the right pudendal nerve or branches or portions thereof or the left pudendal nerve or branches or portions thereof; implanting an hermetically sealed implantable drug pump within the patient, the implantable drug pump configured to receive and house a volume of a drug therewithin, and to deliver a such drug to an exterior thereof via the implantable drug catheter; operably connecting a proximal end of the implantable drug catheter to the implantable drug pump; delivering, from the implantable pulse generator, first electrical stimulation pulses to one of a right pudendal nerve or branches or portions thereof or a left pudendal nerve or branches or portions thereof through the first lead and at least the first electrode, the first pulses being provided in accordance with the first electrical stimulation pulse regime; delivering from the implantable drug pump a predetermined portion of the drug housed therewithin to the exterior thereof through the implantable drug catheter and to the distal end thereof to one of a right pudendal nerve or branches or portions thereof or a left pudendal nerve or branches or portions thereof; wherein the combination of the first electrical pulse regime and the predetermined amount of the drug is delivered in a configuration effective to provide at least partial relief from at least one of constipation, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, prostatitis, prostatalgia and prostatodynia. 37. The method of claim 36, wherein implanting the implantable drug catheter comprises implanting the catheter in the second tissue volume, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to the right pudendal nerve or the left pudendal nerve, and delivering a predetermined portion of the drug comprises delivering the predetermined portion of the drug to the other of the right pudendal nerve or the left pudendal nerve. 38. The method of claim 36, further comprising delivering second electrical stimulation pulses from the implantable pulse generator to at least portions of the second tissue volume via a second implantable medical lead implanted in the second tissue volume. 39. The method of claim 38, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to the right pudendal nerve or the left pudendal nerve, and delivering second electrical stimulation pulses comprises delivering the second electrical stimulation pulses to the other of the right pudendal nerve or the left pudendal nerve. 40. A method of treating at least one diagnosed pelvic floor disorder in a patient, the at least one disorder being selected from the group consisting of prostatalgia and prostatodynia, the method comprising: implanting a distal end of a first implantable medical electrical lead in a first tissue volume of the patient adjacent, around or in one of a right pudendal nerve or branches or portions thereof, a left pudendal nerve or branches or portions thereof, a right sacral nerve or branches or portions thereof, or a left sacral nerve or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least a first electrical stimulation pulse regime via the first lead; implanting the implantable pulse generator within the patient; implanting a distal end of an implantable drug catheter in one of the first tissue volume or a second tissue volume of the patient adjacent, around or in one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof; implanting an hermetically sealed implantable drug pump within the patient, the implantable drug pump configured to receive and house a volume of a drug therewithin, and to deliver such drug to an exterior thereof via the implantable drug catheter; operably connecting a proximal end of the implantable drug catheter to the implantable drug pump; delivering, from the implantable pulse generator, first electrical stimulation pulses to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof through the first lead and at least the first electrode, the first pulses being provided in accordance with the first electrical stimulation pulse regime; and delivering from the implantable drug pump a predetermined portion of the drug housed therewithin to the exterior thereof through the implantable drug catheter and to the distal end thereof to one of the right pudendal nerve or branches or portions thereof, the left pudendal nerve or branches or portions thereof, the right sacral nerve or branches or portions thereof, or the left sacral nerve or branches or portions thereof, wherein the combination of the first electrical pulse regime and the predetermined amount of the drug is delivered in a configuration effective to provide at least partial relief from at least one of prostatalgia and prostatodynia. 41. The method of claim 40, wherein implanting the implantable drug catheter comprises implanting the catheter in the second tissue volume, wherein delivering first electrical stimulation pulses comprises delivering the first electrical stimulation pulses to one of the pudendal nerves or the sacral nerves, and delivering a predetermined portion of the drug comprises delivering the predetermined portion of the drug to the other of the pudendal nerves or the sacral nerves. 42. The method of claim 40, wherein implanting the implantable drug catheter comprises implanting the catheter in the second tissue volume, wherein the first and second tissue volumes are located in respective ones of right and left sides of the patient.

Details for Patent 7,328,069

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2022-09-06