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
  • A61N1/0507—Electrodes for the digestive system
  • A61N1/0514—Electrodes for the urinary tract
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
  • A61F2/042—Urinary bladders
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M2025/0166—Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/09—Guide wires
  • A61M2025/09008—Guide wires having a balloon

Definitions

• the present invention relates to systems and methods for treating patients who have lost the ability to voluntarily control one or more bodily functions such as urination due to spinal cord injury or other neurological disorder. More particularly, embodiments of the invention relate to systems and methods for treating such patients via electrical stimulation of one more tissue sites related to control of urination. Still more particularly, embodiments relate to systems and methods for treating such patients via electrical stimulation of external urethral sphincter.
• the condition can be caused by damage or injury to the brain, or spinal cord or the nerves from the spinal cord which innervate or signal to the organs in the urinary tract such as the sacral nerve and the pudendal nerve.
• Such nerve damage be the result of spinal cord injury (e.g., from a fall, car accident or battlefield injury) or diseases such as multiple sclerosis (MS), Parkinson's disease or diabetes.
• embodiments of the present invention provide a stimulating catheter or other stimulating device for stimulating the EUS and/or to control urination or other urinary function, referred to hereinafter as an EUS stimulating or“EUSS” catheter.
• an EUS stimulating or“EUSS” catheter may correspond to a lead or other elongated member which have one or more features of the catheter described herein.
• the EUSS catheter is configured to be advanced into the patient’s urethra, typically through a lumen of a guiding catheter, and then through the urethra wall and into the EUS by means of the tissue penetrating end of the removable distal tether portion.
• the guiding catheter will typically have a guiding lumen with an exit port which is oriented to deflect the tissue penetrating end of the nerve stimulating electrode laterally.
• the distal tether portion can be then be removed from the catheter body by any one of various detachable mechanisms and/or means known in the catheter and medical leads art.
• the distal tether portion may be configured to be cut from the catheter body using conventional surgical cutting tools.
• such axially spaced-apart electrodes will comprise ring electrodes which at least partially circumscribe the catheter body.
• the width of the electrodes can be in the 1-3 mm range and the spacing between electrodes can be in the 1-5 mm range.
• Other electrode shapes are also contemplated including partial ring shaped (e.g., semi-circular), which may be distributed along a circumference of the EUS catheter body.
• the pulse generator is configured to deliver current at a frequency above about 4 kHz, amperage below about 15 mA, and a voltage in a range from about 40V to 60V. Often, the pulse generator will be configured to deliver bipolar current to at least first and second electrodes on the catheter body.
• Embodiments of such a system are configured to deliver an electrical waveform to nerves adjacent or within a patient’s EUS to stimulate and/or block nerve impulses going to the patient’s EUS so as to cause a physiological action involved in the urination process.
• Such actions may include one or more of opening of patient’s urethra, contraction of the bladder, and relaxation of the bladder.
• the amperage for one or more of the three waveforms is below about 15 mA more preferably below about 4mA, and the voltage is in the range from about 40V to 60V.
• the controller/pulse generator will typically be configured to deliver bipolar current to one or more electrode pairs on the EUS or SNS catheters but, in other instances, could be configured to deliver monopolar current.
• the controller can also be configured to limit the total amount of delivered electrical energy/power to stay below that which would injure, burn, or damage tissue near the nerve stimulation electrodes.
• the guiding catheter lumen through which the EUSS catheter is advanced terminates in a lateral deflection port or aperture which exits on the side of the guiding catheter at a location proximal of the distal tip by a selected distance typically from 1 cm to 15 cm.
• the guiding catheter can include an inflatable anchoring balloon or other anchoring means circumscribing a distal portion of the guiding catheter. Actuation of the anchoring means, typically inflation of the anchoring balloon, anchors the distal portion of the guiding catheter in the bladder.
• the aperture for exit of the EUSS catheter (also referred to as an exit aperture) is placed proximally to the anchoring balloon a selected distance such that it is an approximate alignment to the portion of the urethra near the EUS when the guiding catheter is anchored in the bladder. That is, the balloon or other anchor is positioned in the bladder so that the exit aperture aligns with the section of the urethra containing the EUS.
• the guiding catheter can be manually manipulated by the physician to facilitate the desired alignment. After the EUSS catheter or other EUSS device has been advanced through the guiding catheter and lodged in or adjacent to tissue of urethral wall the anchor may be disengaged (e g., by deflation) and the guiding catheter removed from the urethra. As described below, according to some
• Fig. 1B is a detailed view of a proximal portion of the EUSS catheter of Fig. 1A including nerve stimulation electrodes and an anchoring element shown in partial cross-section.
• Fig. 1C is a detailed view of a distal tip of removable, distal portion of the EUSS catheter taken at line 1C-1C of Fig. 1A.
• Fig. 2A illustrates a guiding catheter to be used together with the EUSS catheter of Figs. 1 A-1D as part of a urinary tract stimulation system for of placement of the EUSS catheter in the urinary tract in accordance with an embodiment of the present invention.
• Fig. 3B illustrates the removable distal portion of the EUSS catheter being advanced further through tissue beyond the external urinary sphincter to a remote region where the pulse generator is to be implanted.
• <extra_id_29>“about” means within ⁇ 10% of a stated property, dimension, or other value and, more preferably, ⁇ 5% of the stated value.
• the term“substantially” means within ⁇ 10% of a stated property or quality and where appropriate within a numerical value of a stated property or quality, more preferably, ⁇ 5% of the stated property or quality. For qualitative properties or qualities such as a pain or injury“substantial” means below that which is overtly and repeatedly perceivable by the patient or medical professional.
• an exemplary embodiment of an EUSS catheter 10 constructed in accordance with the principles of the present invention will typically comprise a catheter body 12 having a proximal and distal end 21 and 22 respectively (distal end 22 also being referred to and/or encompassing a distal tip 22).
• the catheter body is detachably connected at its distal end to a distal portion 14 also referred to as a distal tether 14 or tether 14.
• the catheter body 12 includes a proximal anchor 16 (also referred to as an anchor element 16) at its proximal end 21, a plurality of stimulating electrodes 18 immediately distal to the proximal anchor 16.
• catheter body 12 can be fabricated from various resilient polymers known in the catheter arts including one or more of polyethylene (e.g., HDPE, LDPE), PET, PEBAX, PTFE and copolymers thereof. Further one more of the aforementioned polymers may be irradiated (e.g., via e-beam) for increased stiffness, flexural, tensile, compressive or torsional strength or other desired mechanical property.
• catheter body 12 can be configured to have a compressibility or hardness similar to or less than that of tissue in which it lies adjacent or underneath (e.g., muscle or skin) such the compression of tissue around or skin above the catheter causes little or substantially no pain or discomfort to the patient. Accordingly, in these and related embodiments, catheter body 12 and or the material selected for its construction can have a Shore A harness in the range of 30 to 90, more preferably in a range of about 50 to 90.
• Distal tether 14 may comprise one or more of wire, a polymeric member such as polymer fiber or polymer coated wires such as a polyimide coated wire.
• distal tether 14 comprises a resilient metal wire, such as a nickel -titanium alloy, with sufficient column strength to be pushed from its proximal end through tissue and sufficient tensile strength to be pulled from its distal end to draw the catheter body 12 through tissue.
• a distal tip 24 of the distal tether 14 can be sharpened or otherwise configured to penetrate tissue as the tether is advanced in a distal direction through tissue.
• a guiding catheter 40 used to advance catheter 10 in the patient’s urinary tract comprises an elongated shaft 42 having a hub 44 at its proximal end and an inflatable balloon 46 at its distal end 48.
• the balloon is configured, when inflated, to anchor within a patient’s bladder B immediately above the opening to the urethra U, as shown in Fig.
• Electrodes 18 etc. having selected sizes and shapes can be configured to be removably fitted (e g., by a snap or press fit or other means known in the catheter arts) on to distal portion of the catheter including catheter distal end 22.
• embodiments exist as standalone elements. Also, for any positive recitation of an element, characteristic, constituent, feature, step etc., embodiments of the invention specifically contemplate the exclusion of that element, value, characteristic, constituent, feature or step. Hence, the scope of the present invention is not limited to the specifics of the described embodiments, examples and drawings, but is instead, limited solely by the appended claims.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Public Health (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Heart & Thoracic Surgery (AREA)
• Cardiology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Radiology & Medical Imaging (AREA)
• Pulmonology (AREA)
• Gastroenterology & Hepatology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Vascular Medicine (AREA)
• Epidemiology (AREA)
• Biophysics (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Electrotherapy Devices (AREA)
• Media Introduction/Drainage Providing Device (AREA)

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Publications (1)

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Cited By (2)

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• 2019
  • 2019-10-30 CA CA3117668A patent/CA3117668A1/en active Pending
  • 2019-10-30 JP JP2021523859A patent/JP7476188B2/ja active Active
  • 2019-10-30 AU AU2019369511A patent/AU2019369511A1/en not_active Abandoned
  • 2019-10-30 CN CN201980087598.3A patent/CN113613710A/zh active Pending
  • 2019-10-30 WO PCT/US2019/058881 patent/WO2020092579A1/en not_active Ceased
  • 2019-10-30 EP EP19877888.8A patent/EP3873585A4/en not_active Withdrawn
  • 2019-10-30 US US16/668,672 patent/US11794001B2/en active Active
• 2023
  • 2023-08-09 US US18/447,039 patent/US12133980B2/en active Active
• 2024
  • 2024-10-02 US US18/904,817 patent/US20250025685A1/en active Pending

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