93 results about "Pelvic pain" patented technology

Methods and apparatus for implanting a stimulation lead in a patient's sacrum to deliver neurostimulation therapy that can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve comprises a needle and a dilator and optionally includes a guide wire. The needle is adapted to be inserted posterior to the sacrum through an entry point and guided into a foramen along an insertion path to a desired location. In one variation, a guide wire is inserted through a needle lumen, and the needle is withdrawn. The insertion path is dilated with a dilator inserted over the needle or over the guide wire to a diameter sufficient for inserting a stimulation lead, and the needle or guide wire is removed from the insertion path. The dilator optionally includes a dilator body and a dilator sheath fitted over the dilator body. The stimulation lead is inserted to the desired location through the dilator body lumen or the dilator sheath lumen after removal of the dilator body, and the dilator sheath or body is removed from the insertion path. If the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer, and the stimulation lead is anchored to the fascia layer. The stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

A device for treating a medical condition is provided, and a surgical procedure for implanting the device is disclosed. The device includes a sensor, which is adapted to generate a signal responsive to a state of a patient, and at least one electrode, which is adapted to be coupled to a pelvic site of the patient. A control unit is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode. In various configurations, the device may be used alternatively or additionally to treat fecal incontinence, interstitial cystitis, chronic pelvic pain, or urine retention.

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.

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.

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.

Method embodiments to implant a stimulation lead in a patient's sacrum to deliver neurostimulation therapy can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A method embodiment begins by inserting a needle posterior to the sacrum through an entry point. The needle is guided into a foramen along an insertion path to a desired location. The insertion path is dilated with a dilator to a diameter sufficient for inserting a stimulation lead. The needle is removed from the insertion path. The stimulation lead is inserted to the desired location. The dilator is removed from the insertion path. Additionally if the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer. The stimulation lead is anchored to the fascia layer. After the stimulation lead has been anchored, the incision can be closed, or the stimulation lead proximal end can be tunneled to where an implantable neurostimulator is located and then the incision can be closed. A implanted sacral stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

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.

The present invention relates to implantable or insertable medical devices that treat uterine and urological conditions that cause chronic pelvic pain and other symptoms. In another aspect, the present invention relates to methods of manufacturing such implantable or insertable medical devices.

Described are implantable devices and methods for treating various disorders of the pelvic floor by delivering one or more drugs to a patient's hypogastric nerve or branches or portions thereof, prostatic plexus nerve or branches or portions thereof, sacral splanchnic nerve or branches or portions thereof, pelvic splanchnic nerve or branches or portions thereof, prostate or branches or portions thereof, pelvic floor, colon or branches or portions thereof, bladder or portions thereof, vagina or portions thereof, anus or portions thereof, external anal sphincter or portions thereof, urethra or portions thereof, 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, 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. One, two or more drug delivery regimes are provided on a continuous, alternating, intermittent or other basis to one or more selected nerves, nerve portions or tissues 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.

The present invention relates to implantable or insertable medical devices that treat uterine and urological conditions that cause chronic pelvic pain and other symptoms. In another aspect, the present invention relates to methods of manufacturing such implantable or insertable medical devices.

Methods and apparatus for implanting a stimulation lead in a patient's sacrum to deliver neurostimulation therapy that can reduce patient surgical complications, reduce patient recovery time, and reduce healthcare costs. A surgical instrumentation kit for minimally invasive implantation of a sacral stimulation lead through a foramen of the sacrum in a patient to electrically stimulate a sacral nerve comprises a needle and a dilator and optionally includes a guide wire. The needle is adapted to be inserted posterior to the sacrum through an entry point and guided into a foramen along an insertion path to a desired location. In one variation, a guide wire is inserted through a needle lumen, and the needle is withdrawn. The insertion path is dilated with a dilator inserted over the needle or over the guide wire to a diameter sufficient for inserting a stimulation lead, and the needle or guide wire is removed from the insertion path. The dilator optionally includes a dilator body and a dilator sheath fitted over the dilator body. The stimulation lead is inserted to the desired location through the dilator body lumen or the dilator sheath lumen after removal of the dilator body, and the dilator sheath or body is removed from the insertion path. If the clinician desires to separately anchor the stimulation lead, an incision is created through the entry point from an epidermis to a fascia layer, and the stimulation lead is anchored to the fascia layer. The stimulation lead can be connected to the neurostimulator to delivery therapies to treat pelvic floor disorders such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain.

A device (20) for treating a medical condition is provided, and a surgical procedure for implanting the device is disclosed. The device (20) includes a sensor (44), which is adapted to generate a signal responsive to a state of a patient, and at least one electrode (27), which is adapted to be coupled to a pelvic site of the patient. A control unit (22) is adapted to receive the signal, to analyze the signal so as to distinguish between an imminent stress incontinence event and an imminent urge event, and, responsive to analyzing the signal, to apply an electrical waveform to the at least one electrode (27). In various configurations, the device (20) may be used alternatively or additionally to treat fecal incontinence, interstitial cystitis, chronic pelvic pain, or urine retention.

The disclosure describes methods and systems for alleviating chronic pelvic pain in a subject by intraspinally a therapeutically effective amount of a chronic pelvic pain-alleviating drug. The system includes drug delivery devices and systems for the controlled administration of drugs for alleviation of pelvic pain. The system may deliver drug therapy for pelvic pain in men or women.

Described are implantable devices and methods for treating various disorders of the pelvic floor by delivering one or more drugs to a patient's hypogastric nerve or branches or portions thereof, prostatic plexus nerve or branches or portions thereof, sacral splanchnic nerve or branches or portions thereof, pelvic splanchnic nerve or branches or portions thereof, prostate or branches or portions thereof, pelvic floor, colon or branches or portions thereof, bladder or portions thereof, vagina or portions thereof, anus or portions thereof, external anal sphincter or portions thereof, urethra or portions thereof, 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, 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. One, two or more drug delivery regimes are provided on a continuous, alternating, intermittent or other basis to one or more selected nerves, nerve portions or tissues 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.

Provided herein are kits, compositions, and methods for diagnosing and treating interstitial cystitis (IC) and / or interstitial cystitis / bladder pain syndrome (IC / BPS) based on finding lower levels of certain bacteria in a subject's stool sample (e.g., O. splanchnicus, F. prausnitzii, C. aerofaciens, E. sinensis, L. longoviformis, and R. intestinalis). In certain embodiments, then present invention provides probiotic formulations containing live bacteria (e.g., from O. splanchnicus, F. prausnitzii, C. aerofaciens, E. sinensis, L. longoviformis, and R. intestinalis).

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.

(1) A preventive and / or a remedy for lower urinary tract diseases such as inflammation in the lower urinary tract, cystitis (interstitial cystitis, etc.) and urethritis; (2) an agent for improving bladder compliance and / or bladder capacity; and (3) an agent for protecting bladder mucosa and / or bladder epithelial cells and / or promoting the regeneration thereof; each containing an EP4 agonist. An EP4 agonist is useful in ameliorating symptoms of lower urinary tract diseases such as (1) frequent urination, (2) urgency of urination, (3) pain in the reproductive organs and / or lower urinary tract (for example, bladder pain, urinary tract pain, vulvar pain, vaginal pain, scrotal pain, perineal pain, pelvic pain, etc.) and / or (4) discomfort in the reproductive organs and / or lower urinary tract. Among all, a selective EP4 agonist is useful as a preventive and / or remedy for lower urinary tract diseases having no side effect.

A method and apparatus for treating self treating internal muscle and trigger point related pelvic pain in women and men. The apparatus includes a rod having a handle attached to a straight portion at a first end of the rod and a pressure applicator attached to a second end of the rod, where a first curved portion is disposed between the straight portion of the rod and the second end of the rod. A microcurrent electrical stimulation unit electrically connected to the pressure applicator for supplying an electrical current to the pressure applicator. In the method of the present invention, a trigger point is located in the patient's pelvic floor, the patient inserts the apparatus either vaginally or rectally to allow contact of the pressure applicator of the apparatus with the pelvic floor, pressure is applied to the trigger point using the apparatus, and microcurrent electrical stimulation is applied to the trigger point using a microcurrent electrical stimulation unit that is electrically connected to the pressure applicator.

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.

A method and apparatus for treating self treating internal muscle and trigger point related pelvic pain in women and men. The apparatus includes a rod having a handle attached to a straight portion at a first end of the rod and a pressure applicator attached to a second end of the rod, where a first curved portion is disposed between the straight portion of the rod and the second end of the rod. A microcurrent electrical stimulation unit electrically connected to the pressure applicator for supplying an electrical current to the pressure applicator. In the method of the present invention, a trigger point is located in the patient's pelvic floor, the patient inserts the apparatus either vaginally or rectally to allow contact of the pressure applicator of the apparatus with the pelvic floor, pressure is applied to the trigger point using the apparatus, and microcurrent electrical stimulation is applied to the trigger point using a microcurrent electrical stimulation unit that is electrically connected to the pressure applicator.

The present invention relates to methods for treating neurological-urological conditions. This is accomplished by administration of at least one neurotoxin.

A method and apparatus for self-treating internal muscle and trigger points related to pelvic pain in women and men. The apparatus includes a rod having a handle attached to a straight portion at a first end of the rod and a pressure applicator attached to a second end of the rod, where a first curved portion is disposed between the straight portion of the rod and the second end of the rod. In the method of the present invention, a trigger point is located in the patient's pelvic floor, the patient inserts the apparatus either vaginally or rectally to allow contact of the pressure applicator of the apparatus with the pelvic floor, and pressure is applied to the trigger point using the apparatus.

A hand-held internal therapeutic massager includes a rod having a first portion that defines a curve and a second portion that is substantially straight. The first portion of the rod is adapted to be inserted into a patient's body. A curvature of the curve defined by the first portion of the rod is sufficient to prevent the second portion of the rod from entering a patient's body. A handle is located on the second portion of the rod and a pressure applicator on the first portion of the rod is adapted to be inserted into the patient's body for engagement with a localized area of myofascial tissue. A vibratory device is disposed within the handle and is operable to generate vibrations. The vibrations generated by the vibratory device are conducted through the rod to the pressure applicator to the localized area of myofascial tissue.

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.

Compounds of formula (I), or pharmaceutically acceptable derivatives thereof, wherein: R1 represents H, C1-6-alkyl, C1-6alkyloxy, C3-8cycloalkyl, or halo; R2 represents H, C1-6alkyl (optionally substituted by R3), phenyl (optionally substituted by CN), or Het; R3 represents OH, CN, Het, —R4—C1-6alkyl, or CONR5R6; R4 represents —CO2—, or —O—; R5 and R6 independently represent H, C1-6alkyl (optionally substituted by OR7) or C3-8cycloalkyl; R7 represents H or C1-6alkyl; Het represents a five or six membered aromatic heterocyclic group containing (i) from one to four nitrogen heteroatom(s) or (ii) one or two nitrogen heteroatom(s) and one oxygen or one sulphur heteroatom or (iii) one or two oxygen or sulphur heteroatom(s), said heterocyclic group being optionally substituted by one or more groups selected from CN and C1-6 alkyl; R8 represents C1-6alkyl, C1-6alkyloxy, C3-8cycloalkyl, or halo; R9 and R10 independently represent H, C1-6alkyl, C1-6alkyloxy, CN, CF3 or halo; may be useful for treating endometriosis, uterine fibroids (leiomyomata), menorrhagia, adenomyosis, primary and secondary dysmenorrhoea (including symptoms of dyspareunia, dyschexia and chronic pelvic pain), or chronic pelvic pain syndrome.

Methods and apparatus for implanting a neural stimulation lead in a patient's body are described. A lead assembly comprises a pointed-tip stylet, a stimulation lead, and an optional tube to deploy a fixation element attached to the lead. One embodiment of the implant methods starts with inserting the pointed-tip lead assembly directly into tissue. After the desired implant position is determined, the pointed-tip component is separated from the stimulation lead and removed from the tissue, leaving the stimulation lead implanted. After confirmation that the stimulation lead is in the right tissue location, the pointed-tip component is removed from the body, leaving the stimulation lead in place. The stimulation lead can be connected to a neurostimulator to delivery therapies to treat neural disorders, such as urinary control disorders, fecal control disorders, sexual dysfunction, and pelvic pain, etc.

Methods for decreasing the size and / or changing the shape of pelvic tissues. Energy, preferably radio frequency or laser energy, may be applied to endopelvic fascia or other subcutaneous tissue transcutaneously, through one or more incisions in skin, or directly to the desired subcutaneous tissue after a strip of mucosa or skin has been removed. Such an application of energy may cause the subcutaneous tissue to shrink, thereby bringing the mucosa or skin edges closer together while minimizing damage to deep nerves and other surrounding tissues. Such manipulation of the layers of the skin may be utilized to decrease the size or change the shape of numerous anatomical structures and may also serve to alleviate the symptoms of urinary incontinence, dyspareunia, or chronic pelvic pain. The method steps of the present invention may further provide for the beneficial pretreatment of a tissue site prior to stem cell implantation.

Diagnostic assessment and therapeutic treatment of pelvic pain disorders, including bladder disorders, bowel disorders, and / or reproductive tissue or organ disorders that are characterized by increased expression of the neuropeptides CGRP and / or PACAP. Additionally, applicants have developed a transgenic nonhuman model for pelvic pain disorders, where the transgenic animal expresses in bladder sensory neurons a recombinant neuropeptide implicated in the pelvic pain disorder.