Method, system and device for treating various disorders of the pelvic floor by electrical stimulation of the pudendal nerves and the sacral nerves at different sites
First Claim
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 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 an hermetically sealed implantable electrical pulse generator configured to provide at least first and second electrical stimulation pulse regimes via at least first and second implantable medical electrical leads;
providing the first implantable medical electrical lead, the first lead being configured for implantation adjacent, around or in at least one of a sacral nerve or branches or portions thereof, the first lead comprising proximal and distal ends and at least a first electrode;
providing the second implantable medical electrical lead, the second lead being configured for implantation adjacent a pudendal nerve or branches or portions thereof, the second lead comprising proximal and distal ends and at least a second electrode;
implanting the first lead in or near a first tissue volume of the patient adjacent, around or in one of the sacral nerve or branches or portions thereof;
implanting the second lead in or near a second tissue volume of the patient adjacent, around or in one of the pudendal nerve or branches or portions thereof;
operably connecting the proximal end of the first lead to the implantable pulse generator;
operably connecting the proximal end of the second lead to the implantable pulse generator;
implanting the implantable pulse generator within the patient; and
delivering, from the implantable pulse generator, first electrical stimulation pulses to or near at least portions of the first tissue volume 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 pulse generator, second electrical stimulation pulses to or near at least portions of the second tissue volume 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 through the first and second leads to or near at least portions of the first and second tissue volumes provides to the patient at least partial relief from the pelvic floor disorder.
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Accused Products
Abstract
Described are implantable devices and methods for treating various disorders of the pelvic floor by means of electrical stimulation of the pudendal and sacral nerves, or portions thereof, and optional means for delivering drugs in association therewith. Two or more electrical stimulation regimes are applied on a continuous, alternating, intermittent or other basis to the sacral and pudendal nerves, and optionally one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient'"'"'s pelvic floor and pudendal nerve and/or sacral nerve, or portions thereof, 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.
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Citations
55 Claims
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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 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:
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providing an hermetically sealed implantable electrical pulse generator configured to provide at least first and second electrical stimulation pulse regimes via at least first and second implantable medical electrical leads;
providing the first implantable medical electrical lead, the first lead being configured for implantation adjacent, around or in at least one of a sacral nerve or branches or portions thereof, the first lead comprising proximal and distal ends and at least a first electrode;
providing the second implantable medical electrical lead, the second lead being configured for implantation adjacent a pudendal nerve or branches or portions thereof, the second lead comprising proximal and distal ends and at least a second electrode;
implanting the first lead in or near a first tissue volume of the patient adjacent, around or in one of the sacral nerve or branches or portions thereof;
implanting the second lead in or near a second tissue volume of the patient adjacent, around or in one of the pudendal nerve or branches or portions thereof;
operably connecting the proximal end of the first lead to the implantable pulse generator;
operably connecting the proximal end of the second lead to the implantable pulse generator;
implanting the implantable pulse generator within the patient; and
delivering, from the implantable pulse generator, first electrical stimulation pulses to or near at least portions of the first tissue volume 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 pulse generator, second electrical stimulation pulses to or near at least portions of the second tissue volume 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 through the first and second leads to or near at least portions of the first and second tissue volumes provides to the patient at least partial relief from the pelvic floor disorder. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31)
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32. 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:
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providing a first hermetically sealed implantable electrical pulse generator configured to provide at least a first electrical stimulation pulse regime via at least a first implantable medical electrical lead;
providing a second hermetically sealed implantable electrical pulse generator configured to provide at least a second electrical stimulation pulse regime via at least a second implantable medical electrical lead;
providing the first implantable medical electrical lead, the first lead being configured for implantation adjacent, around or in at least one of a sacral nerve or branches or portions thereof, the first lead comprising proximal and distal ends and at least a first electrode;
providing the second implantable medical electrical lead, the second lead being configured for implantation adjacent a pudendal nerve or branches or portions thereof, the second lead comprising proximal and distal ends and at least a second electrode;
implanting the first lead in or near a first tissue volume of the patient adjacent, around or in one of the sacral nerve or branches or portions thereof;
implanting the second lead in or near a second tissue volume of the patient adjacent, around or in one of the pudendal nerve or branches or portions thereof;
operably connecting the proximal end of the first lead to the first implantable pulse generator;
operably connecting the proximal end of the second lead to the second implantable pulse generator;
implanting the first implantable pulse generator within the patient;
implanting the second implantable pulse generator within the patient; and
delivering, from the first implantable pulse generator, first electrical stimulation pulses to or near at least portions of the first tissue volume 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 second implantable pulse generator, second electrical stimulation pulses to or near at least portions of the second tissue volume 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 through the first and second leads to or near at least portions of the first and second tissue volumes provides to the patient at least partial relief from the pelvic floor disorder. - View Dependent Claims (33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55)
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Specification