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1. WO2016106182 - DISPOSITIFS, SYSTÈMES ET MÉTHODES DE TRAITEMENT DE TROUBLES UROLOGIQUES ET GASTRO-INTESTINAUX PAR STIMULATION ÉLECTRIQUE DU PIED

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

What is claimed is

1. An electrode-containing device comprising either:

a. a base adapted to cover a portion of a plantar surface of a human foot including a portion of the forefoot overlaying a plurality of branches of the medial or lateral plantar nerves and a portion of the hindfoot overlaying the medial and lateral plantar nerves; a first electrode attached to the base at a position adapted to the hindfoot to contact skin overlaying the medial and lateral plantar nerves; a second electrode attached to the base at a position adapted to the forefoot to contact skin overlaying a plurality of branches of the medial or lateral plantar nerves in the forefoot; and a first and second electrical lead attached to the first and second electrodes, respectively, or

b. a base adapted to cover a portion of a dorsal surface of a human foot including a portion of the forefoot overlaying a plurality of branches of the dorsal intermediate and medial cutaneous nerves, deep peroneal nerve, sural nerve, and/or saphenous nerve, and a portion of the hindfoot overlaying the superficial peroneal nerve, deep peroneal nerve, and/or saphenous nerve; a first electrode attached to the base at a position adapted to a dorsal portion of the hindfoot to contact skin overlaying the superficial peroneal nerve, deep peroneal nerve, and/or saphenous nerve; a second electrode attached to the base at a position adapted to a dorsal portion of the forefoot to contact skin overlaying a plurality of branches of the dorsal intermediate and medial cutaneous nerves, deep peroneal nerve, sural nerve, and/or saphenous nerve in the forefoot; and a first and second electrical lead attached to the first and second electrodes, respectively.

2. The electrode-containing device of claim 1, in which the first electrode is a cathode and the second electrode is an anode, or wherein the first electrode is an anode and the second electrode is a cathode.

3. The electrode-containing device of claim 2, in which the first electrode or the second electrode overlays at least 50% of the width of the sole at the forefoot.

4. The electrode-containing device of claim 2, in which the first electrode or the second electrode overlays at least a portion of the metatarsophalangeal joint.

5. The electrode-containing device of claim 2, in which the first electrode or the second electrode overlays at least a portion of the calcaneus bone.

6. The electrode-containing device of claim 2, in which the first electrode or the second electrode overlays a predominance of branches of the medial and lateral plantar nerves in the forefoot.

7. The electrode-containing device of claim 1, wherein the base has a perimeter having the shape of a sole of a foot, and optionally is an orthotic insert, or wherein the base has a perimeter having the shape of the dorsal area of a foot from the proximal phalanges to the talocrural joint.

8. The electrode-containing device of claim 1, wherein the base is a thin polymeric film having an adhesive on a side comprising the electrodes and facing the foot.

9. The electrode-containing device of claim 1, further comprising one or more connectors for an external pulse generator attached to the leads.

10. The electrode-containing device of claim 1, further comprising an adhesive on a surface of the base and/or electrodes for removably securing the device to a patient's foot.

11. The electrode-containing device of claim 1, wherein the base is shaped substantially like a plantar surface or sole of a human foot, or wherein the base is shaped substantially to interact with the dorsal surface of a human foot.

12. An electrical nerve stimulation system comprising:

an electrode-containing device as claimed in claim 1;

a pulse generator external to the electrode-containing device and connected to the leads, configured to generate pulses of pulsewidth 0.01-3 ms between 1-100 V and 1-80 mA, at frequency 1-50 Hz.

13. The system of claim 12, in which the pulse generator comprises an adjustment mechanism for adjusting one or more parameters of the pulses, and wherein the adjustment mechanism comprise a wireless receiver in wireless communication with a wireless controller.

14. The system of claim 12, wherein the pulse generator produces monophasic, rectangular pulses or biphasic pulses.

15. The system of claim 12, wherein the pulse generator provides pulses having a pulsewidth of 0.2 ms at Hz, and wherein the intensity of the pulses is from 2-6 times a toe twitch threshold of a patient.

16. The system of claim 12, wherein the pulse generator provides a fixed output of pulses of pulsewidth 0.01-3 ms between 1-100 V and 1-100 mA, at frequency 1-50 Hz.

17. A method of treating urological or gastrointestinal disorders comprising: applying an electrode-containing device as claimed in claim 1 to a foot of a patient in need of such treatment, wherein the electrode-containing device is attached to a pulse generator external to the electrode-containing device comprising a connector for connecting the pulse generator to the device; and

stimulating the patient's foot with the device with pulses of pulsewidth 0.01-3 ms between 1-100 V and 1-100 mA, at frequency 1-50 Hz, thereby stimulating either the lateral and/or medial plantar nerves or the dorsal intermediate and medial cutaneous nerves, deep peroneal nerve, sural nerve, and/or saphenous nerves of the patient.

18. The method of claim 17, in which the urological or gastrointestinal disorder is one or more of: overactive bladder (OAB) symptoms including bladder overactivity, urinary frequency, urinary urgency, urinary incontinence; interstitial cystitis (IC); urinary retention; pelvic pain; fecal incontinence; irritable bowel syndrome (IBS); and constipation.

19. The method of claim 17, in which the urological or gastrointestinal disorder is urinary incontinence.

20. The method of claim 17, in which the urinary incontinence is bedwetting, and wherein the device delivers pulses of a f equency of 5 Hz, 0.2 ms pulsewidth, and/or from greater than 0 mA to 100 mA, preferably from 2-6 times a toe twitch threshold of a patient.

21. The method of claim 17, wherein the patient's foot is stimulated for from 1 to

360 minutes.

The method of claim 17, wherein the patient's foot is stimulated for at least 30 minutes.

The method of claim 17, wherein the patient's foot is stimulated for at least

180 minutes.

24. The method of claim 17, further comprising administering an anti-muscarinic compound to the patient.

25. The method of claim 24, wherein the anti-muscarinic compound is selected from the group consisting of atropine, benztropine, biperiden, ipratropium, oxitropium, tiotropium, glycopyrrolate, oxybutynin, tolterodine, chlorpheniramine, diphenhydramine, dimenhydrinate, orphenadrine, trihexyphenidyl, and dicyclomine.

26. The method of claim 24, wherein the anti-muscarinic compound is tolterodine.

27. The method of claim 24 wherein the anti-muscarinic compound is administered at between 0.003 and 1 mg/kg and is administered orally or parenterally.

28. The method of claim 17, further comprising administering to a patient in need thereof a serotonin reuptake inhibitor and/or a serotonin receptor antagonist.

29. The method of claim 28, wherein the serotonin reuptake inhibitor is selected from the group consisting of alaproclate, citalopram, dapoxetine, escitalopram, femoxetine, fluoxetine, fluvoxamine, ifoxetine, indalpine, omiloxetine, panuramine, paroxetine, pirandamine, duloxetine, dapoxetine, sertraline, and zimelidine and the serotonin receptor antagonist is selected from the group consisting of alprenolol, AV-965, BMY-7,378, cyanopindolol, dotarizine, flopropione, GR-46,611, isodocyanopindolol, isamoltane, lecozotan, methiothepin, methysergjde, MPPF, NAN-190, oxprenolol, pindobind, pindolol, propranolol, risperidone, robalzotan, SB-649,915 (which acts as both a reuptake inhibitor and a receptor antagonist), SDZ-216,525, spiperone, spiramide, spiroxatrine, UH-301, WAY100135, WAY 100635, and xylamidine.

30. The method of claim 28, wherein the serotonin reuptake inhibitor is duloxetine.

31. The method of claim 28, wherein the serotonin receptor antagonist is

WAY100635.

32. The method of claim 28, comprising administering both a serotonin reuptake inhibitor and a serotonin receptor antagonist, and wherein the serotonin reuptake inhibitor is duloxetine and the serotonin receptor antagonist is WAY100635 and wherein duloxetine is administered at between 0.003 and 5 mg/kg and WAY10063S is administered at between 0.1 and 1 mg kg.

33. The method of claim 28, wherein the serotonin reuptake inhibitor or the serotonin receptor antagonist are administered orally or parenterally.

34. The method of claim 17, further comprising administering an opioid drug to the patient.

35. The method of claim 34, wherein the opioid drug is selected f om the group consisting of tramadol, morphine, codeine, thebaine, diacetylmorphine (morphine diacetate; heroin), nicomorphine (morphine dinicotinate), dipropanoylmorphine (morphine dipropionate), desomorphine, acetylpropionylmorphine, dibenzoylmorphine, diacet ldihydromorphine, hydromorphone, hydrocodone, oxycodone, oxymorphone, ethylmorp,hin bueprenorphine, fentanyl, pethidine, levorphanol, methadone, dextropropoxyphene, tapentadol, endorphins, enkephalins, dynorphins, and endomorphins.

36. The method of claim 34, wherein the opioid drug is tramadol.

37. The method of claim 34, wherein the opioid drug is administered at between 0.003 and 1 mg kg, and is administered orally or parenterally.

38. A method of manufacturing an electrode-containing device comprising either: a. forming a base adapted to cover a portion of a bottom surface of a human foot including a portion of the forefoot overlaying a plurality of branches of the medial or lateral plantar nerves and a portion of the hindfoot overlaying the medial and lateral plantar nerves; attaching a first electrode to the base at a position in the base adapted to contact skin overlaying the medial and lateral plantar nerves; attaching a second electrode to the base at a position in the base adapted to contact skin overlaying a plurality of branches of the medial or lateral plantar nerves in the forefoot; and attaching electrode leads for the first and second electrodes to the base, or

b. forming a base adapted to cover a portion of a dorsal surface of a human foot including a portion of the forefoot overlaying a plurality of branches of the dorsal intermediate and medial cutaneous nerves, deep peroneal nerve, sural nerve, and/or saphenous nerve, and a portion of the hindfoot overlaying the superficial peroneal nerve, deep peroneal nerve, and/or saphenous nerve; attaching a first electrode to the base at a position in the base adapted to contact skin overlaying the superficial peroneal nerve, deep peroneal nerve, and/or saphenous nerve; attaching a second electrode to the base at a position in the base adapted to contact skin overlaying a plurality of branches of the dorsal intermediate and medial cutaneous nerves, deep peroneal nerve, sural nerve, and/or saphenous nerve in the forefoot; and attaching electrode leads for the first and second electrodes to the base.

39. The method of claim 38 wherein the first electrode or the second electrode is adapted to engage skin of the sole of the foot over at least 50% of the width of the forefoot or wherein the first electrode or second electrode is adapted to engage skin of the dorsal surface of the foot over at least 50% of the width of the forefoot.

40. The method of claim 38, in which a plurality of the devices are manufactured to accommodate a plurality of standardized foot sizes.

41. The method of claim 38, in which the electrodes are embedded within the base.

42. The method of claim 38, in which the base is configured to have a perimeter having the shape of a sole of a foot, and optionally is an orthotic insert, or wherein the base is configured to have a perimeter having the shape of the dorsal area of a foot from the proximal phalanges to the talocrural joint.

43. The method of claim 42, wherein electrode leads are embedded within the base.