WO2019058656A1 - Insert doté d'une électrode - Google Patents

Insert doté d'une électrode Download PDF

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Publication number
WO2019058656A1
WO2019058656A1 PCT/JP2018/022321 JP2018022321W WO2019058656A1 WO 2019058656 A1 WO2019058656 A1 WO 2019058656A1 JP 2018022321 W JP2018022321 W JP 2018022321W WO 2019058656 A1 WO2019058656 A1 WO 2019058656A1
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WO
WIPO (PCT)
Prior art keywords
electrode
balloon
bcr
shaft
bladder
Prior art date
Application number
PCT/JP2018/022321
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English (en)
Japanese (ja)
Inventor
武明 新城
浩伸 林
昌彦 川口
Original Assignee
公立大学法人奈良県立医科大学
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 公立大学法人奈良県立医科大学 filed Critical 公立大学法人奈良県立医科大学
Publication of WO2019058656A1 publication Critical patent/WO2019058656A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/20—Measuring for diagnostic purposes; Identification of persons for measuring urological functions restricted to the evaluation of the urinary system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/389—Electromyography [EMG]
    • 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
    • A61N1/06—Electrodes for high-frequency therapy

Definitions

  • the present invention relates to an electroded insert for use in bulb-cavernous body reflection monitoring.
  • the bladder-rectal disorder is a functional disorder showing symptoms such as urinary retention, residual urine, incontinence, delayed incontinence, etc., and is a disorder caused by damage to the central nerve or peripheral nerve and paralysis.
  • Examples of surgery at risk for bladder-rectal disorders include surgery such as spinal cord tethering syndrome removal surgery, paraspinal spinal cord tumor resection, spinal canal stenosis removal surgery and the like. Therefore, when performing these operations, it is necessary to take measures to avoid the bladder-rectal disorder caused by the operation.
  • Non-patent document 1 BCR is one of the sacral cord reflex arches, which means that bulbocavernosus muscles and anal sphincter contract when a penis or clitoris is grasped or pressed with a finger.
  • Non-Patent Document 1 describes a method in which one of two ring-shaped electrodes is wound on the penile coronal groove and the other is wound on the penis body for stimulation of male genital nerve in BCR monitoring.
  • a seal electrode as a stimulation electrode is attached to the penis or clitoris, the amplitude of muscle action potential is observed before and during surgery, and the muscle action potential is, for example, 50% compared to before surgery.
  • the spinal cord has been injured if:
  • Non-Patent Document 2 Non-Patent Document 3
  • BCR monitoring error false positive
  • neuropathy true positive
  • peeling of seal electrode etc. It may be difficult to accurately identify it, and in the case where it is misjudged to be a true positive in the case of a false positive, the operation may be interrupted without completely removing the tumor. In such cases, the patient's disadvantage is significant.
  • the present invention has been made in view of such problems, and it is an object of the present invention to provide an electrode-equipped insert capable of realizing accurate BCR monitoring.
  • the electrode-equipped insert according to the present invention comprises an elongated shaft to be inserted into the urethra, a balloon which is disposed in the vicinity of the tip of the shaft and which is expandable in the bladder, and near the bladder neck when the shaft is inserted into the urethra. And a stimulation electrode provided on the proximal side of the balloon for stimulating the pudendal nerve.
  • (A) shows the BCR amplitude measured by the conventional method and the present invention (the distance L between the proximal end of the balloon and the first electrode is 10 mm) before the start of the operation
  • (B) shows after the end of the operation And BCR amplitude measured according to the conventional method and the present invention.
  • (A) shows the BCR amplitude measured by the conventional method and the present invention (the distance L between the proximal end of the balloon and the first electrode is 20 mm) before the start of the operation
  • (B) shows after the end of the operation And BCR amplitude measured according to the conventional method and the present invention.
  • the present inventors believe that it is difficult to reduce the possibility of false positives by the method of attaching the seal electrode to the body surface such as penis or clitoris, and it is not the case that the seal electrode is attached to the body surface.
  • the electrode-mounted insert 900 has an elongated shaft 100 inserted into the urethra, a balloon 200 expandable in the bladder, and a stimulation electrode 300.
  • the electrode-equipped insert body 900 according to the present embodiment is provided with a stimulation electrode. It is also possible to construct as a urethral catheter.
  • the shaft 100 has a so-called double-pipe structure composed of an outer pipe 120 and an inner pipe 110 which is longer than the outer pipe 120 disposed inside the outer pipe 120.
  • the inner tube 110 is connected to a first hub 130 projecting in a direction different from the axial direction of the shaft 100, and a first lumen extending from the tip of the inner tube 110 to the port of the first hub 130 is formed therein ing.
  • the outer pipe 120 is connected to a second hub 140 projecting in the same direction as the axial direction of the shaft 100, and between the outer peripheral surface of the inner pipe 110 and the inner peripheral surface of the outer pipe 120.
  • a second lumen is formed extending from the tip of the second hub to the port of the second hub 140.
  • the second hub 140 is for an expansion fluid for supplying an expansion fluid for expanding the balloon 200.
  • the “tip” is a term that indicates the position of the device and the device, and the side of the device or device far from the operator when the device or device is used by the operator.
  • proximal part is a term representing the position of the instrument and device, which is the part of the instrument or device closer to the operator when the operator uses it Point to and say.
  • the electrode-equipped insert body 900 of the present invention when moved back and forth in the urethra, it can be safely inserted without damaging the tissue inside the urethra inner wall.
  • Those having flexibility are preferable because of the reason, and metals and resins can be mentioned.
  • metals include pseudoelastic alloys (including superelastic alloys) such as Ni-Ti based alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1, SUS405, SUS430, Examples include SUS434, SUS444, SUS429, SUS430F, SUS302, etc., cobalt-based alloys, gold, noble metals such as platinum, tungsten-based alloys, carbon-based materials, and the like.
  • pseudoelastic alloys such as Ni-Ti based alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1, SUS405, SUS430, Examples include SUS434, SUS444, SUS429, SUS430F, SUS302, etc., cobalt-based alloys, gold, noble metals such as platinum, tungsten-based alloys, carbon
  • polyolefin for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of them, etc.
  • polyvinyl chloride for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of them, etc.
  • polyamide polyamide
  • Polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluorine resins, etc., or mixtures thereof, or polymer materials of two or more of the above can be mentioned.
  • the length of the shaft 100 is not necessarily limited, but the distance from the distal end to the proximal end of the outer tube 120 is, for example, 1000 mm to 2500 mm, preferably 1200 mm to 2300 mm. In addition, the distance from the distal end to the proximal end of the inner tube 110 is, for example, 1200 mm to 2700 mm, preferably 1100 mm to 2600 mm.
  • the inner tube 110 and the outer tube 120 have a substantially circular cross-sectional shape, but the cross-sectional shape may not necessarily be a perfect circular shape, and may be, for example, an elliptical shape.
  • the average outer diameter of the outer tube 120 is preferably 0.3 mm to 3 mm, and preferably 0.5 mm to 2 mm.
  • the average outer diameter of the inner tube 110 is preferably 0.2 mm to 2.8 mm, preferably 0.25 mm to 1.85 mm.
  • a balloon 200 is disposed near the distal end of the shaft 100 and is expandable in the bladder. In the vicinity of the tip of the shaft 100, assuming that the length of the shaft 100 is S, for example, the position of 0.1S to 0.2S from the tip of the shaft 100 is defined. As shown in FIG. 2, the balloon 200 is adhered to the distal end of the inner tube 110 and the distal end of the outer tube 120 and is disposed so as to wrap the opening 121 of the outer tube 120.
  • the balloon 200 is made of a material having a material having flexibility, air tightness and stretchability, for example, a thin film of nylon, polyethylene terephthalate resin, polyamide resin or the like.
  • the thickness of the thin film constituting the balloon 200 is not necessarily limited, but is, for example, 10 ⁇ m to 500 ⁇ m at the time of contraction.
  • the balloon 200 when the balloon 200 is expanded, the balloon 200 has an outer diameter of, for example, 1 mm to 10 mm, preferably 2 mm to 5 mm.
  • the shape of the expanded balloon 200 in FIG. 1 has shown substantially spherical shape, the shape of the expanded balloon is not limited to this, For example, you may have an elliptical spherical shape or another geometric shape.
  • the pudendal nerve branches from the sacral plexus and travels through the pelvic floor to reach the urethral and genital tract.
  • the stimulation electrode 300 for providing electrical stimulation to the pudendal nerve is located in the vicinity of the bladder neck, which is a position distant from the pudendal nerve, for which reason the stimulation electrode 300 is expanded in the bladder. It is provided on the proximal side of a possible balloon 200.
  • the bladder neck is the part that connects the bladder and the urethra, and is shown as the bladder inlet in FIG.
  • the stimulation electrode when the stimulation electrode is positioned in the vicinity of the pudendal nerve, the stimulation electrode may be exposed to the outside due to body movement of the patient.
  • FIG. 4 (B) when the stimulation electrode is positioned in the vicinity of the bladder neck, electrical stimulation to the pudendal nerve is unexpectedly possible, and the patient's movement etc. Even if there is, it is possible to stably place the stimulation electrode in the body.
  • the stimulation electrode 300 is composed of an electrode pair of a first electrode 310 located on the distal end side and a second electrode 320 located on the proximal end side, specifically, a bipolar electrode pair. is there.
  • the distance L between the proximal end 210 of the balloon 200 and the first electrode 310 (the distal end of the first electrode 310) is preferably, for example, 10 mm to 20 mm. As shown in the examples described later, when the distance L is 10 mm and 20 mm, accurate BCR monitoring is possible even though the stimulation electrode is located at a distance from the pudendal nerve.
  • the distance between the first electrode 310 and the second electrode 320 is not particularly limited, but is, for example, 8.0 mm. To 12.0 mm, preferably from 9.0 mm to 11.0 mm, particularly preferably to 10.0 mm.
  • the first electrode 310 and the second electrode 320 are formed, for example, by winding a urethane coated platinum wire with a diameter of 0.06 to 0.10 mm, preferably 0.08 mm, along the diameter of the outer tube 120 multiple times.
  • the first electrode 310 is, for example, a cathode
  • the second electrode 320 is, for example, an anode.
  • the stimulation electrode 300 receives power supply from a high frequency power supply (not shown) via a lead. That is, the urethane-coated platinum wire led from the first electrode 310 and the second electrode 320 passes through the inside of the first lumen (not shown), and goes from the mold portion 400 provided on the side of the second hub 140 to the outside world.
  • the lead is extended as a lead 500 to contact a connection terminal 600 connectable to a high frequency power source.
  • the current applied to the first electrode 310 and the second electrode 320 is not particularly limited as long as it does not adversely affect the human body and enables accurate BCR monitoring, and is, for example, 20 mA to 40 mA. Preferably 25 mA to 35 mA, particularly preferably 30 mA.
  • the shaft 100 is slowly inserted into the urethra of the supine patient.
  • the second hub 140 supplies dilation fluid to expand the balloon 200. Since the stimulation electrode 300 is provided on the proximal end side of the balloon 200, after the shaft 100 is inserted into the urethra, the stimulation electrode 300 is located near the bladder neck (FIG. 4 (B)). After connecting the connection terminal 600 to a high frequency power source, the high frequency power is supplied to the stimulation electrode 300. This makes it possible to apply electrical stimulation from the stimulation electrode 300 to the pudendal nerve.
  • Example 1 As shown in FIG. 5, the insert with electrode according to this example used the following.
  • the outer diameter of the balloon was 14 Fr (the outer diameter is 4.7 mm), the distance from the tip to the proximal end of the outer tube of the shaft was 1000 mm, and the outer diameter of the outer tube was 2 mm.
  • the first electrode (cathode) and the second electrode (anode) are both formed by winding a urethane wire coated 0.08 mm diameter platinum wire around the outer tube of the shaft, and the distance between the first electrode and the second electrode The diameter was 10.0 mm.
  • the distance L between the proximal end of the balloon and the first electrode was 10 mm.
  • the electroded insert according to this example was gently inserted into the patient's urethra for BCR monitoring in the supine position. After that, I changed the posture to the prone position.
  • a recording electrode a total of two needle electrodes were inserted into the anal sphincter and left in place.
  • the electromyograph was a Neuromaster (registered trademark) manufactured by Nippon Kohden Co., and stimulation was performed at 30 mA, 0.5 Hz, 0.2 to 0.5 msec duration, and an electromyographic waveform due to the stimulation was measured.
  • FIG. 6 (A) shows BCR amplitudes of controls (before the start of surgery) in the conventional method and the present invention, respectively.
  • FIG. 6 (B) shows the BCR amplitude at the end of surgery in the conventional method and in the present invention, respectively.
  • the drop in amplitude was significant compared to the control. This is considered to be attributable to partial peeling of the attached seal electrode.
  • Example 2 Next, the BCR amplitude was determined in the same manner as in Example 1 except that the distance L between the proximal end of the balloon and the first electrode was set to 20 mm.
  • FIG. 7 (A) shows BCR amplitudes of controls (before the start of surgery) in the conventional method and the present invention, respectively.
  • FIG. 7 (B) shows the BCR amplitude at the end of surgery in the conventional method and in the present invention, respectively.
  • Example 3 the BCR amplitude was measured in the same manner as in Example 1 except that the distance L between the proximal end of the balloon and the first electrode was 5 mm. Although BCR amplitude could be measured stably as compared with the conventional method, in rare cases the stimulation electrode might intrude into the patient's bladder.
  • Example 4 the BCR amplitude was measured in the same manner as in Example 1 except that the distance L between the proximal end of the balloon and the first electrode was 40 mm or 60 mm. Although BCR amplitude could be measured stably compared to the conventional method, in rare cases the stimulation electrode could escape from the urethral of the patient.
  • use of the electrode-equipped insert according to the present invention enables accurate BCR monitoring, which is particularly useful when the patient is a woman or a child.
  • shaft 110 inner tube 120: outer tube 130: first hub 140: second hub 200: balloon 300: stimulation electrode 310: first electrode 320: second electrode 400: mold portion 500: lead wire 600: connection terminal 900: Insert with electrode

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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)
  • Heart & Thoracic Surgery (AREA)
  • Surgery (AREA)
  • Molecular Biology (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Urology & Nephrology (AREA)
  • Physiology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Electrotherapy Devices (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

L'invention concerne un insert doté d'une électrode qui permet une surveillance précise du réflexe bulbo-caverneux (RBC). La présente invention comprend : une tige allongée (100) destinée à être insérée dans l'urètre ; un ballonnet (200) qui est disposé près d'une section d'extrémité distale de la tige (100) et qui peut être gonflé dans la vessie ; et une électrode de stimulation (300) qui est agencée sur un côté de section d'extrémité proximale du ballonnet, qui est située à proximité d'une section de col de vessie lorsque la tige (100) est insérée dans l'urètre et qui stimule le nerf pudendal.
PCT/JP2018/022321 2017-09-21 2018-06-12 Insert doté d'une électrode WO2019058656A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017-181205 2017-09-21
JP2017181205A JP2019055026A (ja) 2017-09-21 2017-09-21 電極付挿入体

Publications (1)

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WO2019058656A1 true WO2019058656A1 (fr) 2019-03-28

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113331938A (zh) * 2021-06-25 2021-09-03 武汉半边天医疗技术发展有限公司 一种微塑型温控射频诊疗系统

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010540109A (ja) * 2007-09-25 2010-12-24 ウローバル インコーポレイテッド 患者の症状を診断するための筋肉反射の測定の取得
JP2017500072A (ja) * 2013-11-01 2017-01-05 メドトロニック・ゾーメド・インコーポレーテッド リング電極を有するフォーリーカテーテル

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2010540109A (ja) * 2007-09-25 2010-12-24 ウローバル インコーポレイテッド 患者の症状を診断するための筋肉反射の測定の取得
JP2017500072A (ja) * 2013-11-01 2017-01-05 メドトロニック・ゾーメド・インコーポレーテッド リング電極を有するフォーリーカテーテル

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
HARADA, NAOYUKI ET AL.: "Recording techniques of bulbocavernous reflex for infant and female patients", SPINAL SURGERY, vol. 29, no. 1, April 2015 (2015-04-01), pages 81 - 84, ISSN: 0914-6024 *
SARICA YAKUP ET AL.: "CEREBRAL RESPONSES EVOKED BY STIMULATION OF THE VESICO-URETHRAL JUNCTION IN NORMAL SUBJECTS", ELECTROENCEPHALOGRAPHY AND CLINICAL NEUROPHYSIOLOGY, vol. 65, no. 6, November 1986 (1986-11-01), pages 440 - 446, XP024335706 *
SUGIYAMA KUNIO ET AL: "Verification of stimulus area in bulbocavernosus reflex (BCR) monitoring", JAPANESE JOURNAL OF CLINICAL NEUROPHYSIOLOGY, vol. 43, no. 5, 2015, pages 433 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113331938A (zh) * 2021-06-25 2021-09-03 武汉半边天医疗技术发展有限公司 一种微塑型温控射频诊疗系统
CN113331938B (zh) * 2021-06-25 2022-06-17 武汉半边天医疗技术发展有限公司 一种微塑型温控射频诊疗系统

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