WO2019058656A1

WO2019058656A1 - Electrode-equipped insert

Info

Publication number: WO2019058656A1
Application number: PCT/JP2018/022321
Authority: WO
Inventors: 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: 2017-09-21
Filing date: 2018-06-12
Publication date: 2019-03-28
Also published as: JP2019055026A

Abstract

Provided is an electrode-equipped insert that enables accurate BCR (bulbocavernosus reflex) monitoring. The present invention includes: an elongated shaft 100 to be inserted into the urethra; a balloon 200 that is disposed near a distal end section of the shaft 100 and that is inflatable in the bladder; and a stimulating electrode 300 that is provided on a proximal end section side of the balloon, that is located in the vicinity of a bladder neck section when the shaft 100 is inserted into the urethra, and that stimulates the pudendal nerve.

Description

Insert with electrode

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.

As a measure to avoid this bladder-rectal disorder, there is monitoring of bulbocavernosus reflex (hereinafter sometimes abbreviated as BCR: bulbocavernous reflex) (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.

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. There are also methods to assess that the spinal cord has been injured if:

However, when the seal electrode is attached to the penis or clitoris, the seal electrode may peel off over time during the operation due to the patient's body movement etc. Especially in the case of a woman, it may be minimality and wet environment of the seal attachment point. In combination, it is difficult to measure the amplitude of muscle action potential in BCR monitoring (Non-Patent Document 2, Non-Patent Document 3).

If the amplitude of muscle action potential in BCR monitoring decreases during surgery, there may be either BCR monitoring error (false positive) due to neuropathy (true positive) due to surgical operation or 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.

According to the present invention, accurate BCR monitoring is possible.

It is a figure explaining the outline of the insert with an electrode concerning this embodiment. It is a figure explaining a shaft tip part. It is a figure explaining the driving | running | working state of the pudendal nerve. (A) is a figure explaining the case where a stimulation electrode is located near the pudendal nerve, (B) is a figure explaining the case where a stimulation electrode is located near the bladder neck. It is a photograph figure of the insert body with an electrode concerning a present Example. (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.

Hereinafter, embodiments of the present invention will be specifically described with reference to the accompanying drawings, which are for the purpose of facilitating the understanding of the principle of the present invention, and the scope of the present invention is as follows: The present invention is not limited to the embodiment, and other embodiments in which a person skilled in the art substitutes the configuration of the following embodiments as appropriate are also included in the scope of 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. We devised a technique to stimulate the pudendal nerve from the body by inserting an electrode into the urethra of the In addition, it has been thought that it is necessary to locate the electrode near the pudendal nerve because it is necessary to appropriately transmit the electrical stimulation to the pudendal nerve in order to realize accurate BCR monitoring, but in the present invention, the pudendal region Electrodes are positioned near the bladder neck, a location spaced from the nerve, to stimulate the pudendal nerve.

As shown in FIG. 1, the electrode-mounted insert 900 according to the present embodiment has an elongated shaft 100 inserted into the urethra, a balloon 200 expandable in the bladder, and a stimulation electrode 300. In addition, since the so-called urethral catheter is configured to have an elongated shaft inserted into the urethra and a balloon expandable in the bladder, 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.

As shown in FIG. 2, 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. On the other hand, 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.

As used herein, 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. Refers to a part, and the term "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.

As a forming material of the outer tube 120 and the inner tube 110 of the shaft 100, when the electrode-equipped insert body 900 of the present invention is 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. Examples of 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. As the resin, for example, 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, 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.

As shown in FIG. 1, 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 μm to 500 μm at the time of contraction. When the fluid flowing through the second lumen extending between the outer circumferential surface of the inner tube 110 and the inner circumferential surface of the outer tube 120 is supplied to the balloon 200, the balloon 200 can expand. On the other hand, when the fluid in the expanded balloon 200 returns to the second lumen, the balloon 200 contracts. Thus, the expansion and contraction of the balloon 200 can be controlled.

In the present invention, 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. In addition, although 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.

As shown in FIG. 3, the pudendal nerve branches from the sacral plexus and travels through the pelvic floor to reach the urethral and genital tract. As described above, in the present invention, 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. Although the flow of the pudendal nerve in the case of a woman is described in FIG. 3, the application target of the present invention is not limited to a woman, and is applicable to a male, and further applicable to children as well as adults. It is applicable.

As shown in FIG. 4A, 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. On the other hand, as shown in 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.

As shown in FIG. 1, 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 (the distance between the distal end of the first electrode 310 and the proximal end of 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, and 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.

When the operator instructs high frequency treatment on the operation panel (not shown), high frequency power is supplied to the stimulation electrode 300, and a high frequency current flows between the first electrode 310 and the second electrode 320. 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.

Next, a usage form of the electrode-equipped insert 900 according to the present embodiment will be described. After general anesthesia is introduced into the patient, the shaft 100 is slowly inserted into the urethra of the supine patient. After confirming that the balloon 200 has penetrated the inside of the bladder through the bladder neck, 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. In the stimulation electrode, 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.

After induction of general anesthesia, 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. As 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.

In conventional BCR monitoring, after induction of general anesthesia, a seal electrode was attached to the clitoris of the patient in a supine position. Detection of contraction of the anal sphincter muscle was based on the same method as this example.

The results are shown in FIG. 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. In the conventional method, 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.

The results are shown in FIG. 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. When the electrode insert of the present invention is used, it has been found that the change in BCR amplitude is scarce and stable before the start of the operation and at the end of the operation, and the monitoring of the BCR amplitude becomes possible. In the conventional method, the drop in amplitude was significant compared to the control.

(Example 3)
Next, 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)
Next, 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.

As described above, 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.

It can be used for BCR monitoring.

100: 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

Claims

An elongated shaft inserted into the urethra;
A balloon expandable within the bladder, disposed near the tip of the shaft;
And a stimulation electrode provided on the proximal side of the balloon for stimulating the pudendal nerve, which is positioned near the bladder neck when the shaft is inserted into the urethra.
Inserts with electrodes used for bulb-cavernous reflex monitoring.
The stimulation electrode comprises an electrode pair of a first electrode located on the distal end side and a second electrode located on the proximal end side, and the distance between the proximal end of the balloon and the first electrode is 10 mm The electrode-equipped insert according to claim 1, characterized in that it is between 20 mm and 20 mm.
The electrode-equipped insert according to claim 2, wherein a distance between the first electrode and the second electrode is 8.0 mm to 12.0 mm.