Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
  • A61N1/0521—Genital electrodes
  • A61N1/0524—Vaginal electrodes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode

Definitions

• Embodiments of the present invention generally relate to the implantation of one or more electrodes into the urinary sphincter of a patient.
• Implantable electronic stimulator devices such as neuromuscular stimulation devices, have been disclosed for use in the treatment of various pelvic conditions, such as urinary incontinence, fecal incontinence and sexual dysfunction.
• Such devices generally include one or more electrodes that are coupled to a control unit by leads. Electrical signals are applied to the desired pelvic muscle of the patient, such as the urinary sphincter, through electrodes in order to treat the condition.
• Exemplary implantable electronic stimulator devices and uses of the devices are disclosed in U.S. Patent Nos. 6,354,991, 6,652,449,
• Embodiments of the present invention are generally directed to a method of implanting an electrode lead in a patient and, more particularly, to a method of positioning a stimulating portion of an electrode lead in physical contact with the urinary sphincter of the patient.
• an electrode lead (104) is provided (160) comprising a lead body (105) and a stimulating portion (112) at a distal end (1 10) of the lead body, the stimulating portion comprises at least one electrode (114). The stimulating portion is then positioned (162) in physical contact with the urinary sphincter ( 136) of the patient.
• the positioning of the stimulating portion comprises feeding the distal end of the lead body through tissue (152) of the patient along a path (381) that extends from a posterior side (166) of the urethra to the anterior side of the urethra, wherein a section (183) of the path is in physical contact with the urinary sphincter.
• the stimulating portion is positioned in the section of the path.
• an electrode lead (104) is provided (210) comprising a lead body (105), a stimulating portion (112) comprising at least one electrode (314) at a distal end (110) of the lead body, and an anchor (124) attached to the distal end of the lead body.
• the distal end of the lead body is then fed (212) along a path (214) that extends from a posterior side (166) of the periurethral fascia (143) into the periurethral fascia, wherein a section (218) of the path is in physical contact with the urinary sphincter (136).
• the stimulating portion is then positioned (220) in the section of a path.
• the anchor is then fed (222) out of the periurethral fascia to the posterior side of the periurethral fascia and the position of the stimulating portion is anchored (224) using the anchor.
• FIG. 1 is a simplified side plan view of an exemplary electronic stimulator device including a magnified schematic illustration of a distal end of an exemplary electrode lead, in accordance with one or more embodiments of the invention.
• FIGS. 2 and 3 are schematic illustrations of certain pelvic anatomy of a female and a male patient, respectively, that illustrate method steps in accordance with one or more embodiments of the invention.
• FIG. 4 is a flowchart illustrating steps of a method in accordance with one or more embodiments of the invention.
• FIG. 5 is a simplified perspective view illustrating a target site for a stimulating portion of an electrode lead in accordance with one or more embodiments of the invention.
• FIG. 6 is a flowchart illustrating one or more embodiments of a method step of positioning a stimulating portion in physical contact with the urinary sphincter of a patient.
• FIGS. 7-12 are simplified front cross-sectional views of the target site for a stimulating portion of an electrode lead illustrating method steps in accordance with one or more embodiments of the invention.
• FIG. 13 is a flowchart illustrating a method of implanting an electrode lead in a patient in accordance with one or more embodiments of the invention.
• FIGS. 14 and 15 are simplified side cross-sectional views of a target site for a stimulating portion of an electrode lead and illustrate method steps in accordance with one or more embodiments of the invention.
• Embodiments of the present invention are directed to a method of positioning an electrode lead in physical contact with the urinary sphincter of a female or male patient.
• an exemplary implantable electronic stimulator device will be described with reference to FIG. 1.
• FIG. 1 is a schematic, pictorial view of an exemplary implantable electronic stimulator device 100, in accordance with one or more embodiments of the invention.
• the device 100 is configured for implantation into the pelvic region of a patient and to provide muscle stimulation that is used to control and/or treat a pelvic condition, such as urinary incontinence and other pelvic conditions.
• the device 100 comprises a control unit 102 and one or more electrode leads 104 each comprising a lead body 105 having a proximal end 106 that is coupled to the control unit via a connector 108, and a distal end 110 having a stimulating portion 112.
• the stimulating portion 112 comprises one or more electrodes, generally referred to as 114, such as electrodes 114A and 1 14B.
• Additional leads 104 or physiological sensors may be coupled to the control unit 102 at a suitable interface, such as interface 116.
• EMG electromyogram
• the control unit 102 and the electrodes 114 can operate as described in the above-referenced patents, in PCT Patent Publication WO 00-19940, entitled “Incontinence Treatment Device,” and/or in PCT Patent Publication WO 00- 19939, entitled “Control of Urge Incontinence,” with appropriate changes as are otherwise indicated by clinical and engineering considerations that are clear to those skilled in the art.
• the electrodes 114 can take on any suitable form for delivering electrical signals to the tissue in which they are implanted.
• the electrodes 114 comprise electrically conductive material, such as a biocompatible metal such as silver, a platinum/indium alloy (90-10) or a nickel-chromium alloy, having an exposed exterior surface that contacts the tissue of the patient in which the distal end 110 is implanted.
• the electrodes 114 are electrically isolated from each other by one ore more electrically insulative sections 118 in the stimulating portion 112. Electrical wires 120 couple the one or more electrodes 114 to the control unit 102 through the lead body 105 and are protected by an insulating jacket of the lead body 105 typically comprising silicone, polyurethane or and other flexible, biocompatible insulating material.
• the distal end 110 of the lead body 105 can be anchored to a pelvic floor muscle or other tissue of the patient by means of an anchor 124, which is shown in the magnified schematic illustration of the distal end 110 of the lead 104 provided in FIG. 1.
• Embodiments of the anchor 124 include a helical coil, a hook, mesh, a suture, and/or other anchor known in the art.
• control unit 102 comprises circuitry for processing electrical signals (e.g., EMG signals) received from the one or more electrodes 114 and/or for applying an electrical stimulation waveform to the one or more electrodes 114.
• electrical signals e.g., EMG signals
• control unit can communicate electrical signals to each electrode 114 independently.
• the electrical stimulation waveforms are designed to control and/or treat the desired condition of the pelvic region, such as urinary incontinence.
• the circuitry is contained in a case 126 made of titanium or other suitable biocompatible metal.
• the case 126 is about 20 millimeters in diameter and 4 millimeters thick.
• the case 126 serves as a ground electrode for the electrodes 114 when they are sensing or stimulating in a monopolar mode.
• the case 126 may comprise metal coated with a layer of biocompatible plastic, such as polymethyl methacrylate (PMMA) or silicon, for example.
• PMMA polymethyl methacrylate
• FIGS. 2 and 3 are schematic illustrations of certain pelvic anatomy of a female and a male patient, respectively, including the urethra 130, the bladder 132, the urinary sphincter (i.e., sphincter urethrae) 136, the pubic symphysis 138 and the perineal membrane 140.
• FIG. 2 also depicts the vagina 142 and periurethral fascia 143.
• FIG. 3 also illustrates the prostate 144 and the penis 145, through which the urethra 130 extends, the "bulbar urethra" 146, the corpus spongiosum 148 and the buibospongiosus muscle 150.
• the urinary sphincter 136 is unable to sufficiently constrict the urethra 130 to prevent the passage of urine from the bladder 132 during moments of abdominal strain (stress incontinence), such as during coughing, and/or in response to bladder contractions (urge incontinence).
• Stress incontinence moments of abdominal strain
• bladder contractions bladder contractions
• Embodiments of the invention relate to the treatment of stress and/or urge incontinence through the application of electrical stimulation waveforms to the urinary sphincter muscle 136.
• electrical stimulation can increase the tone of the urinary sphincter muscle 136 to prevent or reduce the likelihood of stress incontinence, and can also inhibit contraction of the bladder 132 to prevent or reduce the likelihood of urge incontinence.
• one or more embodiments of the invention are directed to a method of implanting the stimulating portion 112 such that one or more electrodes 114 are placed in physical contact with the urinary sphincter 136 of a female patient or a male patient, as schematically illustrated in FIGS. 2 and 3, respectively, in order to deliver the electrical stimulation waveforms generated by the control unit 102 to the urinary sphincter 136 to directly treat urge and/or stress incontinence.
• Embodiments of the method should be interpreted as applying to both female and male patients, when reasonable.
• Embodiments of the invention also include the application of one or more of the embodiments described herein to only a female patient.
• Embodiments of the invention also include the application of one or more of the embodiments described herein to only a male patient.
• FIG, 4 is a flowchart illustrating steps of a method in accordance with one or more embodiments of the invention.
• FIG. 5 is a simplified perspective view illustrating a target site for the stimulating portion 112 of the lead 104 that includes a portion of the urethra 130, the urinary sphincter 136 and surrounding tissue 152, such as periurethral fascia, for example.
• an electrode lead 104 is provided comprising a lead body 105 and a stimulating portion 112 at a distal end 110 of the lead body 105.
• the stimulating portion 112 includes at least one electrode 114 (FIG. 1).
• At 162 at least a portion of the stimulating portion 112 is positioned in physical contact with the urinary sphincter 136 and over the anterior side 164 of the urethra 130, such as illustrated in FIG. 5.
• the stimulating portion 112 abuts the urinary sphincter 136 and/or is embedded in the urinary sphincter 136. That is all or one or more portions of the stimulating portion 112 may lay against the urinary sphincter 136, all or one or more portions of the stimulating portion 112 may be embedded in (i.e., fed through) the urinary sphincter, or all or one or more portions of the stimulating portion 112 may lay against and be embedded in the urinary sphincter 136.
• the drawings may depict embodiments in which all or a portion of the stimulating portion 112 is, for example, embedded in the urinary sphincter 136, it is understood that the above-described embodiments in which a portion of the stimulating portion 112 lays against the sphincter 136, is an alternative embodiment.
• the stimulating portion 112 is not placed in physical contact with the urinary sphincter 136. Rather, at least a portion of the stimulating portion 112 is placed in close proximity to the urinary sphincter 112, such as less than 5 millimeters.
• step 162 comprises feeding the distal end 110 of the lead body 105 through the tissue 152 of the patient from a posterior side 166 of the urethra 130 to the anterior side 164 of the urethra 130, such as illustrated in FIG. 5.
• the tissue 152 comprises the periurethral fascia 143 (FIG. 2) of a female patient, through which the distal end 110 of the lead body 105 is fed.
• an incision such as along line 170 of FlG. 2, is made through the epithelial tissue of the vagina 142 to expose the periurethral fascia 143 before feeding the dista! end 110 through the periurethral fascia 143.
• the tissue 152 through which the distal end 110 of the lead body 105 is fed comprises the bulbospongiosus muscle 150 (FIG. 3) of a male patient.
• the distal end 110 of the lead body 105 is fed through the bulbospongiosus muscle 150 of a male patient in step 162.
• a perineal incision is made prior to feeding the distal end 110 of the lead body through the bulbospongiosus muscle 150 of the patient, such as a perineal incision along line 172 shown in FIG. 3.
• FIG. 6 is a flowchart illustrating one or more embodiments of step 162.
• FIGS. 7-12 are simplified front cross- sectional views of the target site for the stimulating portion 112 of the electrode lead 104 taken along a line that is approximately perpendicular to the longitudinal axis 174 of the urethra 130 adjacent the target site, and illustrate method steps in accordance with one or more embodiments of the invention.
• a path, represented by line 181 is dilated through the tissue 152 of the patient from the posterior side 166 of the urethra 130 to the anterior side 164 of the urethra.
• the tissue 152 when the patient is female, the tissue 152 includes periurethral fascia 143 and the path 181 extends from the posterior side 166 of the periurethral fascia 143 to the anterior side 164 of the periurethral fascia 143, as shown in FIGS. 7-12. However, for the male patient, the tissue 152 does not include the depicted periurethral fascia 143.
• At least a portion of the section 183 of the path 181 physically contacts (i.e., abuts or travels through) the urinary sphincter 136. In one embodiment, at least a portion of the section 183 of the path 181 is embedded (i.e., passes through) in the urinary sphincter 136. as shown in FIGS. 7-10. In one embodiment, at least a portion of the section 183 of the path 181 abuts or lays against the urinary sphincter 136, as shown in FIGS. 11-12.
• the path 181 is formed through the tissue 152 by feeding a dilator guide 182 along the path 181 through the tissue 152, as illustrated in FIG. 7.
• the path 181 travels from the posterior side 166 of the urethra 130 along a lateral side 184 of the urethra to the anterior side 164 of the urethra 130.
• the dilator guide 182 comprises a curved needle 185, an example of which is shown in FIG. 7.
• the dilator guide 182 comprises a suture 188 that is positioned along the path 181 using, for example the curved needle 185, as shown in FIG. 8.
• a dilator sheath 190 is fed along the dilator guide 182, as shown in FIG. 8.
• the dilator sheath 190 may be fed over the needle 185 or the suture 188 (shown in FIG. 8) that are positioned along the desired path 181.
• the sheath 190 is fed along the guide 182 from the posterior side 166 of the urethra 130 to the anterior side 164 of the urethra.
• the dilator sheath 190 is initially attached to the dilator guide 182 during the feeding of the guide 182 along the path 181. Once the sheath 190 is in the desired position along the path 181, the guide 182 can be removed.
• the distal end 1 10 of the lead body 105 is fed along the path 181,
• the distal end 110 of the lead body 105 is fed through the dilator sheath 190 along the path 181, as shown in FIG. 9.
• the dilator guide 182 is attached to the distal end 110 of the lead body 105, such as the suture 188, and is used to assist the feeding of the distal end 110 of the lead body 105 through the dilator sheath 190.
• step 162 comprises feeding the distal end 110 of the lead body 105 along the path 181 using the dilator sheath 190.
• the stimulating portion 1 12 of the electrode lead 104 is positioned in the section 183 of the path 181 that is in physical contact with the urinary sphincter 136, as shown in FIG. 9.
• the dilator sheath 190 is removed from the path 181 leaving one or more of the electrodes 114 of the stimulating portion 1 12 in the section 183 of the path 181 and in physical contact with the urinary sphincter 136, as shown in FIG, 10.
• the path 181 extends transversely to the longitudinal axis 174, as shown in FIGS. 5 and 7. In one embodiment, at least a portion of the section 183 of the path 181 extends substantially perpendicularly to the longitudinal axis 174 of the urethra 130. In one embodiment, the term "substantially perpendicularly” means that the tangent to a portion of the section 183 of the path 181 is angled less than 45 degrees to a plane that is perpendicular to the longitudinal axis 174 of the urethra 130.
• FIG. 11 illustrates the stimulating portion 112 of the electrode lead 104 in the section 183 of the path 181 in accordance with another embodiment of the invention.
• the path 181 extends from the posterior side 166 of the urethra 130, along the lateral side 184 of the urethra 130, over the anterior side 164 of the urethra 130 and along a lateral side 198 of the urethra 130 that is opposite the side 186.
• FIG. 12 illustrates the simulating portion 112 of the electrode lead 104 positioned in the section 183 of the path 181 in accordance with another embodiment of the invention.
• the path 181 extends from the posterior side 166 of the urethra 130, along the lateral side 184 of the urethra 130, over the anterior side 164 of the urethra 130, along the lateral side 198 of the urethra 130 and terminates on the posterior side 166 of the urethra 130.
• the path 181 substantially encircles the urethra 130.
• the term "substantially encircles” means that the path 181 surrounds more than approximately 270 degrees of the urethra 130.
• the distal end 110 of the lead 104 substantially encircles the urethra 130.
• one embodiment of the electrode lead 104 includes the anchor 124 attached to the distal end 110 of the lead body 105.
• the anchor 124 is attached to the terminating end of the lead body 105.
• the anchor 124 is fed through the tissue 152 to the posterior side 166 of the urethra 130 and the position of the stimulating portion 112 is secured in a section 183 of the path 181 using the anchor 124.
• the distal end 204 of the anchor member is fed from the anterior side 164 of the periurethral fascia 143 to the posterior side 166, as shown in FIGS. 9-11.
• the anchor 124 comprises an anchor member 200 (e.g., suture, mesh, tine, etc.) having a proximal end 202 attached to the distal end 110 of the lead body 105 and a distal end 204, as illustrated in FIGS. 9-10.
• the distal end 204 is attached to tissue of the patient, as illustrated in FIG. 9.
• the distal end 204 of the anchor member 200 is attached to a portion 206 of the lead body 105 that is displaced from the distal end 110 or the terminating end of the lead body 105, as shown in FIG. 10.
• the portion 206 is located on the posterior side 166 of the periurethral fascia 143.
• the anchor 124 comprises a portion 207, illustrated in FIG. 11, that is attached to the terminating end 208 of the lead body 105 and is sized to prevent the terminating end 208 from migrating back along the path 181 through the periurethral fascia 143.
• the portion 207 is attached to the terminating end 208 of the lead body 105 after the terminating end 208 is fed to the posterior side 166 of the - ⁇ - periurethral fascia 143.
• the portion 207 is fed along the path 181 with the lead body 105 and is allowed to expand after is fed through the periurethral fascia 143 to the posterior side 166 of the periurethral fascia 143.
• Examples of the portion 207 include a collar, mesh, tines, or other suitable anchors.
• the terminating end 208 is attached to the portion 206 to complete the encircling of the urethra 130 and anchor the stimulating portion 112 in the section 183 of the path 181, as shown in FIG. 12,
• the end 208 can be attached to the portion 206 using any suitable technique, such as with a clamp or clip, a suture, biocompatible adhesive, or other suitable technique.
• FIG. 13 is a flowchart illustrating a method of implanting an electrode lead in a patient in accordance with one or more embodiments of the invention.
• FIGS. 14 and 15 are simplified side cross- sectional views of the target site for the stimulating portion 112 of the electrode lead 104.
• an electrode lead 104 is provided that comprises a lead body 105, a stimulating portion 112 including at least one electrode 114 at a distal end 110 of the lead body, and an anchor 124 attached to the distal end 110 of the lead body 105, as shown in FIG. 1.
• Embodiments of the anchor 124 include a suture, helical coil, a hook, mesh, and/or other anchor known in the art.
• the distal end 1 10 of the lead body 105 is fed along a path
• an incision is made in the epithelial tissue of the vagina 142, such as along line 170 shown in FIG. 2, to expose the periurethral fascia 143 and the path 214 is dilated.
• the distal end 110 of the lead body 105 is then fed along the dilated path 214.
• the techniques used to dilate the path 214 include those described above.
• the path 214 can be formed in the periurethral fascia 143 and the urinary sphincter 136 by feeding a dilator guide (e.g., a needle, an introducer, a suture, etc.) along the path 214, as discussed above with reference to FIG. 7.
• a dilator guide e.g., a needle, an introducer, a suture, etc.
• a dilator sheath such as dilator sheath 190 is fed along the dilator guide positioned in the path 214, as described above with reference to FIG. 8.
• the distal end 110 of the lead body 105 is fed along the path 214 using the dilator sheath, such as by feeding the distal end 110 of lead body 105 through the dilator sheath, as described above with reference to FIG. 9.
• the stimulating portion 1 12 is positioned in the section 218 of the path 214, as shown in FIG. 15. This places one or more of the electrodes 114 of the stimulating portion 112 in physical contact with the urinary sphincter 136. In one embodiment, at least a portion of the stimulating portion 112 is embedded in the urinary sphincter 136 when the section 218 extends through the urinary sphincter 136. In one embodiment, at least a portion of the stimulating portion 112 abuts the urinary sphincter 136, as illustrated by the phantom image of the stimulating portion 112, when the section 218 of the path 214 runs alongside the urinary sphincter 136. When the distal end 110 of the lead 104 is fed through a dilator sheath, as discussed above with reference to FIG. 10, the stimulating portion is positioned within the section 218 of the path 214 by removing the dilator sheath.
• the anchor 124 is fed out of the periurethral fascia 143 to the posterior side 166 of the periurethral fascia.
• the position of the stimulating portion 112 is anchored using the anchor 124.
• the anchor 124 is attached to tissue 226 located on the posterior side 166 in accordance with conventional anchoring techniques.
• the anchor 124 comprises an anchor member 200 having a proximal end 202 and a distal end 204, as illustrated in FIG. 15.
• the proximal end 202 is attached to the distal end 110 of the lead body 105.
• the position of the stimulating portion 112 in the section 218 of the path 214 is anchored by attaching the distal end 204 of the anchor member 200 to a portion of the lead body 105 that is displaced from the distal end 110 or the terminating end of the lead body 105, as shown in FIG. 15.
• the distal end 204 of the anchor member 200 is secured to tissue 226 of the patient on the posterior side 166 of the periurethral fascia 143.
• the terminating end of the lead body 105 is attached to the lead body, as described above with reference to FIG. 12.
• the proximal end 106 of the electrode lead 104 is attached to the control unit 102 of the electronic stimulator device 100, as illustrated in FIG. 2. This preferably occurs after the position of the stimulating end 112 has been thoroughly tested and shown to effectively stimulate the urinary sphincter 136.
• the control unit is implanted in the patient, such as in the abdominal region, such as illustrated schematically in FIG. 2, in accordance with conventional techniques.
• the proximal end 106 of the electrode lead 104 may be fed along a pre-pubic subcutaneous path as shown in FIGS. 2 and 3 or along a retropubic path (i.e., posterior to the pubic symphysis 138).

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• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
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• Life Sciences & Earth Sciences (AREA)
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• Electrotherapy Devices (AREA)

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Citations (4)

• 2010
  • 2010-07-02 WO PCT/US2010/040920 patent/WO2011003072A2/fr active Application Filing

Patent Citations (6)

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