Method, system and device for treating disorders of the pelvic floor by means of electrical stimulation of the pudendal and associated nerves, and the optional delivery of drugs in association therewith
First Claim
1. A method for treating at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia in a patient, comprising:
- implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode;
operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead;
implanting the implantable pulse generator within the patient; and
delivering electrical stimulation pulses from the implantable pulse generator to one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia.
1 Assignment
0 Petitions
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 or other nerves, and optional means for delivering drugs in association therewith. A method of precisely positioning and implanting a medical electrical lead so as to provide optimal stimulation of the pudendal nerve or a portion thereof is also described. Placement of a stimulation lead next to or on the pudendal nerve may be performed using conventional prior art techniques through gross anatomical positioning, but usually does not result in truly optimal lead placement. One method of the present invention utilizes neurophysiological monitoring to assess the evoked responses of the pudendal nerve, and thereby provide a method for determining the optimal stimulation site. Additionally, one or more electrical stimulation signals are applied, and optionally one or more drugs are infused, injected or otherwise administered, to appropriate portions of a patient'"'"'s pelvic floor and pudendal 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
28 Claims
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1. A method for treating at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia in a patient, comprising:
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implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead; implanting the implantable pulse generator within the patient; and delivering electrical stimulation pulses from the implantable pulse generator to one of the bladder or portions thereof, the vagina or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, sacro-tuberous ligament or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for treating urinary retention disorder in a patient comprising:
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implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the pudendal nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, the pelvic splanchnic nerve or branches or portions thereof, the prostate or branches or portions thereof, the pelvic floor, the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Carnal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foremen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead; implanting the implantable pulse generator within the patient; and delivering electrical stimulation pulses from the implantable pulse generator to one of the pudendal nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, the pelvic splanchnic nerve or branches or portions thereof, the prostate or branches or portions thereof, the pelvic floor, the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portion thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from urinary retention disorder. - View Dependent Claims (20)
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21. A method for treating at least one of prostatitis, prostatalgia or prostatodynia in a patient, comprising:
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implanting a distal end of a first implantable medical electrical lead in tissue of the patient adjacent, around or in one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead; implanting the implantable pulse generator within the patient; and delivering electrical stimulation pulses front the implantable pulse generator to one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and delivered in a configuration effective to provide at least partial relief from at least one of prostatitis, prostatalgia or prostatodynia, wherein the electrical stimulation pulses that are delivered to one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof cause paresthesia, or the masking or blocking pain signals originating in or carried by a desired or target nerve or nerve portion located in the vicinity of the at least one electrode. - View Dependent Claims (22, 23, 24)
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25. A method for treating at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia in a patient, comprising:
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delivering stimulation to a plurality of locations via a St. Mark'"'"'s electrode, the locations comprising one or more of the sacral nerve or branches or portions thereof, the pudendal nerve or branches or portions thereof, the hypogastric nerve or branches or portions thereof, the prostatic plexus nerve or branches or portions thereof, the sacral splanchnic nerve or branches or portions thereof, the pelvic splanchnic nerve or branches or portions thereof, the prostate or branches or portions thereof, the pelvic floor, the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, the penile dorsal nerve or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, Alcock'"'"'s Canal or branches or portions thereof, sacro-tuberous ligament or branches or portions thereof, ischial tuberosity or branches or portions thereof, greater sciatic foramen or branches or portions thereof, or lesser sciatic foramen or branches or portions thereof; sensing an evoked response for each of the locations; selecting one of the locations based on the evoked responses; implanting electrodes of the first implantable medical electrical lead in tissue of the patient adjacent, around or in the selected location; and delivering electrical stimulation pulses from an implantable electrical pulse generator to at least a portion of the tissue of the patient through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and providing to the patient at least partial relief from at least one of urinary voiding dysfunction, fecal voiding dysfunction, constipation, incontinence, urge frequency disorder, urinary retention disorder, sexual dysfunction, orgasmic dysfunction, erectile dysfunction, pelvic pain, prostatitis, prostatalgia and prostatodynia. - View Dependent Claims (26, 27)
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28. A method for treating pelvic pain comprising:
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implanting a distal end of at least a first medical electrical lead in tissue of the patient adjacent, around or in at least one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, or the sacro-tuberous ligament or branches or portions thereof, wherein the first lead comprises at least a first electrode; operably connecting a proximal end of the at least first lead to an hermetically sealed implantable electrical pulse generator configured to provide at least one electrical stimulation pulse regime via at least the first lead; implanting the implantable pulse generator within the patient; and delivering electrical stimulation pulses from the implantable pulse generator to at least one of the colon or branches or portions thereof, the bladder or portions thereof, the vagina or portions thereof, the anus or portions thereof, the external anal sphincter or portions thereof, the urethra or portions thereof, inferior rectal nerves or branches or portions thereof, perineal nerves or branches or portions thereof, scrotal nerves or branches or portions thereof, the scrotum or portions thereof, or the sacro-tuberous ligament or branches or portions thereof through the at least first lead and electrode, the pulses being provided in accordance with the electrical stimulation pulse regime and in a configuration effective to provide the patient at least partial relief from pelvic pain, wherein the electrical stimulation pulses that are delivered to the desired nerve target sites or portions cause paresthesia, or the masking or blocking pain signals originating in or carried by a desired or target nerve or nerve portion located in the vicinity of the at least one electrode.
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Specification