Method, system and device for treating disorders of the pelvic floor by drug delivery to the pudendal and sacral nerves

• US 7,276,057 B2
• Filed: 04/30/2004
• Issued: 10/02/2007
• Est. Priority Date: 09/06/2002
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin T.
• Primary Examiner(s): Sirmons; Kevin C.
• Assistant Examiner(s): MacNeil; Elizabeth
• Application Number:
  US10/836,433
• Publication Number:
  US 20050021008A1
• Time in Patent Office: 1,250 Days
• Field of Search: 6048901-8921, 604/502, 604/503
• US Class Current: 604/891.1
• CPC Class Codes: A61N 1/326 for promoting growth of cells, e.g. bone cells
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain

Abstract

Described are implantable devices and methods for treating various disorders of the pelvic floor by delivering one or more drugs to a sacral nerve or nerve portion, as well as to a pudendal nerve or nerve portion. Two or more drug delivery regimes are provided on a continuous, alternating, intermittent or other basis to the sacral and pudendal nerves in an amount and manner effective to treat a number of disorders, including, but not limited to, urinary and/or fecal voiding dysfunctions such as constipation, incontinence disorders such as urge frequency and urinary retention disorders, sexual dysfunctions such as orgasmic and erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.

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 prostatitis, prostatalgia and prostatodynia, the method comprising:

providing a first hermetically sealed implantable drug pump configured to receive and house a volume of a first drug therewithin, and to deliver such first drug to a first exterior thereof via a first implantable drug catheter;

providing the first drug catheter, the first drug catheter comprising proximal and distal ends;

implanting the first drug catheter in or near a first tissue volume of the patient adjacent, around or in one of a plurality of sacral nerves or branches or portions thereof, or one of a plurality of pudendal nerves or branches or portions thereof;

operably connecting the proximal end of the first drug catheter to the first implantable drug pump; and

delivering, from the first implantable drug pump, a first predetermined portion of the first drug housed therewithin to the exterior thereof through the first implantable drug catheter to the distal end thereof to or near at least portions of the first tissue volume;

wherein delivery of the first drug to the first tissue volume provides to the patient at least partial relief from the pelvic floor disorder.

2. The method of claim 1, wherein the first drug catheter has disposed at or near its distal end a fixation mechanism selected from the group consisting of a suture sleeve, a barb, a helical screw, a hook and a tissue in-growth mechanism.

3. The method of claim 1, wherein the first drug catheter has an outer diameter selected from the group consisting of less than about 5 mm in diameter, less tan about 3 mm in diameter and less than about 1 mm in diameter.

4. The method of claim 1, wherein the distance between the proximal and distal ends of the first drug catheter is selected from the group consisting of about 6 inches, about 8 inches, about 10 inches, about 12 inches, about 14 inches, about 16 inches about 18 inches, about 20 inches and more than about 20 inches.

5. The method of claim 1, wherein a predetermined drug delivery regime is delivered in response to a sensed physical parameter or symptom.

6. The method of claim 1, wherein a predetermined drug delivery regime is one of activated, modified and terminated in response to a physical parameter or symptom being sensed.

7. The method of claim 6, wherein the physical parameter is sensed using a sensor selected from the group consisting of a bladder pressure sensor, a leak sensor, a volume sensor, a urinary volume or pressure sensor, a urinary impedance sensor, a nerve electrical signal sensor, and an electromyographic sensor.

8. The method of claim 1, wherein the first drug is delivered to the first tissue volume at a predetermined relatively constant rate.

9. The method of claim 1, wherein the first drug is delivered to the first tissue volume at predetermined intervals.

10. The method of claim 1, wherein the first drug is selected from the group consisting of antimuscarinic drugs, anticloinergic drugs, membrane channel drugs, channel blocker drugs, alpha adrenoceptor antagonist drugs, beta adrenoceptor agonist drugs, antidepressant drugs, prostatglandin synthesis inhibitor drugs, motor neuron suppression drugs, sensory desensitization drugs, anti-inflammatory drugs, pain relief drugs and hormone drugs.

11. The method of claim 1, wherein the first drug is selected from the group consisting of tolterodine, trospium, propantheline, atropine, hyoscyamine, darifenacin, solifenacin, calcium antagonists, potassium channel openers, terodiline, oxybuynin, propiverine, flaxoxate, alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, terbutaline, chenbuterol, salbutomol, imipramine, indomethacin, flurbiprofen. baclofen, resiniferatoxin, capsaicin, dimethyl sulfoxide, bacillus Calmette-Guerin (BCG) and estrogen.

12. The method of claim 1, wherein the first drug is selected from the group consisting of an alpha adrenoceptor antagonist, a beta adrenoceptor agonist, adrenaline, a serotonin uptake inhibitor, duloxetine, a hormone, ephedrine, norephedrine, propranolol, imipramine, duloxetine, alfuzosin, doxazosin, prazosin, terazosin, tamsulosin, phenoxybenzamine, bethanechol, carbahol, distigmine, and estrogen.

13. The method of claim 1, wherein the first drug is selected from the group consisting of an antibiotic, an analgesic, a tricyclic antidepressant, a muscle relaxant, a smooth muscle relaxant, a hormone replacement agent, a libido enhancer, a vascular dilator, and a selective serotonin re-uptake inhibitor.

14. The method of claim 1, wherein the first drug is selected from the group consisting of flouroquinolone, trimethoprimsulfamethoxazole, aspirin, acetaminophen, phenazopyridine, opioids, meperidine, hydromorphone, methandone, levorphanol and morphine.

15. The method of claim 1, wherein the first 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, imipramine, hyoscyamine, oxybutynin chloride, cyclobenzprine, hyoscyamine sulfate, tolterodine tartrate and resiniferatoxin.

16. The method of claim 1, wherein the first drug is selected from the group consisting of an anti-diarrheal agent, a motility inhibition agent, and a motility stimulation agent.

17. The method of claim 1, wherein the first drug is selected from the group consisting of loperamide, alosetron, diphenoxylate, difenoxin, alosetron, cilansetron, tagaserod, cisapride, erythomycin, caffeine and amitriptyline.

18. The method of claim 1, wherein the first drug is selected from the group consisting of sildenafil, estrogen, testosterone, L-arginine, phentolamine, amantadine, bupropion, buspione, cypropeptadine, dextroamphetamine, pemoline, yohimbine, vardenafil, tadalafil, prostaglandin, sertraline, paroxetine, end clomipramine.

19. The method of claim 1, further comprising:

providing a second hermetically sealed implantable drug pump configured to receive and house a volume of a second drug therewithin, and to deliver such second drug to a second exterior thereof via a second implantable drug catheter;

providing the second drug catheter, the second drug catheter comprising proximal and distal ends;

implanting the second drug catheter in or near a second tissue volume of the patient adjacent, around or in one of the plurality of sacral nerves or branches or portions thereof, or one of the plurality of pudendal nerves or branches or portions thereof;

operably connecting the proximal end of the second drug catheter to the second implantable drug pump; and

delivering, from the second implantable drug pump, a second predetermined portion of the second drug housed therewithin to the exterior thereof through the second implantable drug catheter to the distal end thereof to or near at least portions of the second tissue volume;

wherein a combination of the delivery of the first drug to the first tissue volume and the second drug to the second tissue volume provides to the patient at least partial relief from the pelvic floor disorder.

20. The method of claim 19, wherein the first and second tissue volumes are located in respective ones of a right side and a left side of the patient.

21. The method of claim 20, wherein the first tissue volume is around or in one of the plurality of sacral nerves or branches or portions thereof, and the second tissue volume is around or in one of the plurality of pudendal nerves or branches or portions thereof.

22. The method of claim 19, wherein the first and second drugs have different compositions.

23. The method of claim 19, wherein the first and second drugs have substantially the same compositions.

24. The method of claim 19, wherein at least one of activation, modification and termination of a drug delivery regime provided by at least one of the first drug pump and the second drug pump is carried out by the patient or a health care giver.

25. The method of claim 24, wherein the at least one of activation, modification and termination of the drug delivery regime is carried out in response to patient'"'"'s symptoms appearing or disappearing, or the patient feeling or not feeling symptoms.

26. The method of claim 19, wherein at least one of the first drug pump and the second drug pump is a peristaltic drug pump.

27. The method of claim 19, wherein the first and second drug pumps are disposed within a single hermetically sealed housing.

28. The method of claim 19, wherein the second drug is delivered to the second tissue volume at a predetermined relatively constant rate.

29. The method of claim 19, wherein the second drug is delivered to the second tissue volume at predetermined intervals.

30. 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 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, the method comprising:

providing a first hermetically sealed implantable drug pump configured to receive and house a volume of a first drug therewithin, and to deliver such first drug to a first exterior thereof via a first implantable drug catheter;

providing the first drug catheter, the first drug catheter comprising proximal and distal ends;

providing a second hermetically sealed implantable drug pump configured to receive and house a volume of a second drug therewithin, and to deliver such second drug to a second exterior thereof via a second implantable drug catheter;

providing the second drug catheter, the second drug catheter comprising proximal and distal ends;

implanting the first drug catheter in or near a first tissue volume of the patient adjacent, around or in one of the a plurality of sacral nerves or branches or portions thereof on a first side of the patient;

operably connecting the proximal end of the first drug catheter to the first implantable drug pump; and

implanting the second drug catheter in or near a second tissue volume of the patient adjacent, around or in one of a plurality of pudendal nerves or branches or portions thereof on a second side of the patient;

operably connecting the proximal end of the second drug catheter to the second implantable drug pump;

delivering, from the first implantable drug pump, a first predetermined portion of the first drug housed therewithin to the exterior thereof through the first implantable drug catheter to the distal end thereof to or near at least portions of the first tissue volume;

delivering, from the second implantable drug pump, a second predetermined portion of the second drug housed therewithin to the exterior thereof through the second implantable drug catheter to the distal end thereof to or near at least portions of the second tissue volume;

wherein the combination of the delivery of the first drug to the first tissue volume and the second drug to the second tissue volume provides to the patient at least partial relief from the pelvic floor disorder.