JP2019055026A - Insertion body with electrodes - Google Patents

Abstract

To provide an insertion body with electrodes capable of accurate BCR monitoring.SOLUTION: An insertion body with electrodes has: an elongate shaft 100 to be inserted in the urinary tract; a balloon 200 which is arranged near an end part of the shaft 100 and can expand in the bladder; and a stimulating electrode 300 provided on a balloon base end part side which is positioned near the bladder neck when the shaft 100 is inserted in the urinary tract to stimulate the pudendal nerves.SELECTED DRAWING: Figure 1

Description

  The present invention relates to an electrode-attached insert used for spherical cavernous reflection monitoring.

  Bladder and rectal disorders are functional disorders that show symptoms such as urinary retention, residual urine, incontinence, and delay in urination, and are disorders that result from injury or paralysis of the central nerve or peripheral nerve. Surgery at risk of bladder rectal disorder includes, for example, operations such as spinal cord anchorage relief surgery, intraspinal tumor removal, spinal canal stenosis relief, and the like. Therefore, when performing these operations, it is necessary to take measures to avoid bladder and rectal disorders due to the operation.

  As a measure for avoiding this bladder rectal disorder, there is monitoring of the spongiform reflex (hereinafter sometimes abbreviated as BCR: bulbocavernous reflex) (Non-patent Document 1). BCR is one of the sacral reflex arches. When the penis or clitoris is grasped or pressed with a finger, the cavernous and anal sphincter muscles contract. Non-Patent Document 1 describes a technique of winding one of two ring-shaped electrodes around the penile coronal groove and the other around the penile body for stimulating pudendal nerves in men in BCR monitoring.

  In BCR monitoring, a seal electrode as a stimulation electrode is attached to the penis or clitoris, and the amplitude of the muscle action potential is observed before and during the operation. For example, the muscle action potential is 50% of that before the operation. There is also a technique to evaluate that the spinal cord is injured if:

  However, when the seal electrode is applied to the penis or clitoris, the seal electrode may peel off over time due to patient movement, etc., especially in the case of women, the seal application location may be minimal and moist. Together, it is difficult to measure the amplitude of the muscle action potential in BCR monitoring (Non-patent Documents 2 and 3).

  If the amplitude of my action potential in BCR monitoring decreases during surgery, either neurological damage due to surgery (true positive) or BCR monitoring mistake (false positive) due to peeling of the seal electrode, etc. may be considered. In some cases, it may be difficult to accurately determine this, and in fact, if the false positive is misjudged as true positive, the operation may be interrupted without completely removing the tumor. Yes, in such cases, the patient's disadvantage is significant.

Yoneda Katsunori Examination of spherical cavernous reflexes by evoked electromyography Flancesco S: Intraoperative neurophysiology in tethered cord surgery: techniques and results.Child ’s Nerv Syst (2013) 29: 1611-1624 Naoyuki Harada et al. Problems of Spherical Cavernous Reflex (BCR) in Spinal Cord Surgery in Women and Children Spinal Surgery 29 (1) 81-84,2015

  The present invention has been made in view of such problems, and an object thereof is to provide an electrode-attached body that can realize accurate BCR monitoring.

  The electrode-attached insert according to the present invention includes an elongated shaft to be inserted into the urethra, a balloon that is disposed in the vicinity of the tip of the shaft and is inflatable in the bladder, and the vicinity of 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 insertion object with an electrode concerning this embodiment. It is a figure explaining a shaft tip part. It is a figure explaining the running state of a pudendal nerve. (A) is a figure explaining the case where the stimulation electrode is located near the pudendal nerve, and (B) is the figure explaining the case where the stimulation electrode is located near the bladder neck. It is a photograph figure of the insertion object with an electrode concerning a present Example. (A) is a figure which shows the BCR amplitude measured by the conventional method and the present invention (distance L between the proximal end of the balloon and the first electrode is 10 mm) before the start of surgery, and (B) is after the end of surgery. It is a figure which shows the BCR amplitude measured by the conventional method in this and this invention. (A) is a figure which shows the BCR amplitude measured by the conventional method and the present invention (distance L between the proximal end of the balloon and the first electrode is 20 mm) before the start of surgery, and (B) is after the end of surgery. It is a figure which shows the BCR amplitude measured by the conventional method in this and this invention.

  Hereinafter, embodiments of the present invention will be specifically described with reference to the accompanying drawings. However, the embodiments are for facilitating 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 embodiments, and other embodiments in which those skilled in the art appropriately replace the configurations of the following embodiments are also included in the scope of the present invention.

  The present inventors consider that it is difficult to reduce the possibility of false positives by applying a seal electrode to the body surface such as the penis and clitoris, and instead of applying a seal electrode to the body surface, the patient We have devised a technique for stimulating the pudendal nerve from the body by inserting electrodes into the urethra. In order to realize accurate BCR monitoring, it has been considered that it is necessary to appropriately transmit electrical stimulation to the pudendal nerve, so it is necessary to position the electrode in the vicinity of the pudendal nerve. An electrode is positioned in the vicinity of the bladder neck, which is a position away from the nerve, to stimulate the pudendal nerve.

  As shown in FIG. 1, the electrode-equipped insert 900 according to the present embodiment includes an elongated shaft 100 that is inserted into the urethra, a balloon 200 that is inflatable in the bladder, and a stimulation electrode 300. Since the so-called urinary catheter has an elongated shaft inserted into the urethra and a balloon that is inflatable in the bladder, the electrode-equipped insert 900 according to this embodiment includes a stimulation electrode. It can also be configured as a urinary catheter.

  As shown in FIG. 2, the shaft 100 has a so-called double pipe structure including an outer pipe 120 and an inner pipe 110 that is longer than the outer pipe 120 disposed inside the outer pipe 120. The inner tube 110 is connected to a first hub 130 protruding 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 tube 120 is connected to a second hub 140 protruding in the same direction as the axial direction of the shaft 100, and the outer tube 120 is interposed between the outer peripheral surface of the inner tube 110 and the inner peripheral surface of the outer tube 120. A second lumen extending from the distal end of the second hub 140 to the port of the second hub 140 is formed. The second hub 140 is for expansion fluid for supplying expansion fluid for expanding the balloon 200.

  The “tip portion” used in this specification is a term indicating the position of the instrument and the device, and when the operator uses the instrument or the device, the distal side of the instrument or the device far from the operator is used. The term “proximal end” refers to the position of the instrument and device, and the part of the instrument or device closer to the operator when the operator uses the instrument or device. Point to and say.

  As a material for forming the outer tube 120 and the inner tube 110 of the shaft 100, when the electrode-equipped insert 900 of the present invention is moved back and forth in the urethra, it can be safely inserted without damaging the urethral inner wall tissue. For this reason, those having flexibility are preferable, and examples thereof include metals and resins. Examples of metals include pseudo-elastic alloys (including super-elastic alloys) such as Ni-Ti alloys, shape memory alloys, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302, etc.), cobalt alloys, gold, noble metals such as platinum, tungsten alloys, carbon materials and the like. Examples of the resin include polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), polyvinyl chloride, polyamide, polyamide. Examples thereof include polymer materials such as elastomers, polyesters, polyester elastomers, polyurethanes, polyurethane elastomers, polyimides, fluororesins, mixtures thereof, and the above two or more polymer materials.

  The length of the shaft 100 is not necessarily limited, but the distance from the distal end portion to the proximal end portion of the outer tube 120 is, for example, 1000 mm to 2500 mm, preferably 1200 mm to 2300 mm. The distance from the distal end portion to the proximal end portion of the inner tube 110 is, for example, 1200 mm to 2700 mm, preferably 1100 mm to 2600 mm. Although the inner tube 110 and the outer tube 120 have a substantially circular cross-sectional shape, the cross-sectional shape does not necessarily have to be a perfect circle, 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, and preferably 0.25 mm to 1.85 mm.

  As shown in FIG. 1, the balloon 200 is disposed in the vicinity of the distal end portion of the shaft 100 and is inflatable in the bladder. Note that the vicinity of the tip of the shaft 100 defines the position of 0.1S to 0.2S from the tip of the shaft 100, for example, where S is the length of the shaft 100. As shown in FIG. 2, the balloon 200 is bonded to the distal end portion of the inner tube 110 and the distal end portion of the outer tube 120 so as to wrap around the opening 121 of the outer tube 120. The balloon 200 is composed of a material having a material having flexibility, airtightness, and stretchability, for example, a thin film such as nylon, polyethylene terephthalate resin, polyamide resin or the like.

  Although the thickness of the thin film which comprises the balloon 200 is not necessarily limited, For example, they are 10 micrometers-500 micrometers at the time of shrinkage | contraction. When the fluid flowing through the second lumen extending between the outer peripheral surface of the inner tube 110 and the inner peripheral surface of the outer tube 120 is supplied to the balloon 200, the balloon 200 can be expanded. On the other hand, when the fluid in the expanded balloon 200 returns to the second lumen, the balloon 200 contracts. In this way, 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 shows a substantially spherical shape, the shape of the expanded balloon is not limited to this, and may have an elliptical spherical shape or other geometric shapes, for example.

  As shown in FIG. 3, the pudendal nerve branches off from the sacral plexus, travels through the pelvic floor, and reaches the urethral orifice / genital organ. As described above, in the present invention, the stimulation electrode 300 for applying electrical stimulation to the pudendal nerve is intentionally positioned in the vicinity of the bladder neck, which is a position away from the pudendal nerve. For this reason, the stimulation electrode 300 is expanded in the bladder. It is provided on the proximal end side of the possible balloon 200. The bladder neck is a portion connecting the bladder and the urethra, and is shown as a bladder inlet in FIG. Although FIG. 3 shows the flow of the pudendal nerve in the case of a woman, the application target of the present invention is not limited to a woman and can be applied to a man. 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 the patient's body movement or the like. On the other hand, as shown in FIG. 4 (B), when the stimulation electrode is positioned in the vicinity of the bladder neck, unexpectedly, electrical stimulation to the pudendal nerve is possible, and the patient's body movement or the like Even if it exists, 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 10 mm to 20 mm, for example. 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 position away from the pudendal nerve.

  The interval between the first electrode 310 and the second electrode 320 (the interval between the distal end portion of the first electrode 310 and the proximal end portion of the second electrode 320) is not particularly limited, but is, for example, 8.0 mm. ˜12.0 mm, preferably 9.0 mm to 11.0 mm, particularly preferably 10.0 mm.

  The first electrode 310 and the second electrode 320 are formed, for example, by winding a urethane-coated platinum wire having a diameter of 0.06 to 0.10 mm, preferably 0.08 mm, around the outer tube 120 a plurality of times. The first electrode 310 is, for example, a cathode, and the second electrode 320 is, for example, an anode.

  The stimulation electrode 300 is supplied with electric power from a high-frequency power source (not shown) through a conductive wire. 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 part 400 provided on the side of the second hub 140 to the outside. The lead wire 500 is extended as a lead wire 500 and connected to a connection terminal 600 that can be connected to a high-frequency power source.

  When the surgeon instructs high frequency treatment on an operation panel (not shown), high frequency power is supplied to the stimulation electrode 300, and 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 allows accurate BCR monitoring, and is, for example, 20 mA to 40 mA. Preferably it is 25mA-35mA, Most preferably, it is 30mA.

  Next, a usage pattern of the electrode-equipped insert 900 according to the present embodiment will be described. After introducing general anesthesia to the patient, the shaft 100 is slowly inserted into the urethra of the patient in the supine position. After confirming that the balloon 200 has entered the bladder through the bladder neck, an expansion fluid is supplied from the second hub 140 to expand the balloon 200. Since the stimulation electrode 300 is provided on the proximal end side of the balloon 200, the stimulation electrode 300 is positioned in the vicinity of the bladder neck after the shaft 100 is inserted into the urethra (FIG. 4B). After connecting the connection terminal 600 to the high frequency power source, high frequency power is supplied to the stimulation electrode 300. As a result, electrical stimulation can be applied from the stimulation electrode 300 to the pudendal nerve.

Example 1
As shown in FIG. 5, the electrode-inserted body according to this example used the following. The outer diameter of the balloon was 14 Fr (outer diameter 4.7 mm), the distance from the distal end portion to the proximal end portion 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, both the first electrode (cathode) and the second electrode (anode) are formed by winding a platinum wire with a diameter of 0.08 mm around the outer tube of the shaft, and the distance between the first electrode and the second electrode. Was 10.0 mm. The distance L between the proximal end of the balloon and the first electrode was 10 mm.

  After introduction of general anesthesia, the electrode-attached insert according to this example was gently inserted into the urethra of the patient for BCR monitoring in the supine position. After that, the posture was changed to prone position. As a recording electrode, a pair of left and right needle electrodes in total was inserted into the anal sphincter. A neuromaster (registered trademark) manufactured by Nihon Kohden Co., Ltd. was used as the electromyograph, stimulation was performed at 30 mA, 0.5 Hz, and 0.2 to 0.5 msec duration, and the electromyogram waveform due to the stimulation was measured.

  In conventional BCR monitoring, a seal electrode was applied to the patient's clitoris in the supine position after introducing general anesthesia. The anal sphincter contraction was detected by the same technique as in this example.

  The results are shown in FIG. FIG. 6 (A) shows the BCR amplitude of the control (before the start of surgery) in each of the conventional method and the present invention. FIG. 6B shows the BCR amplitude at the end of surgery in the conventional method and each of the present invention. In the conventional method, the decrease in amplitude was significant compared to the control. This is considered to be due to the part of the attached seal electrode being peeled off.

(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 20 mm.

  The results are shown in FIG. FIG. 7 (A) shows the BCR amplitude of the control (before the start of surgery) in each of the conventional method and the present invention. FIG. 7B shows the BCR amplitude at the end of surgery in the conventional method and each of the present invention. When the electrode insert of the present invention was used, it was found that the change in BCR amplitude was scarce before the start of surgery and at the end of the surgery, and the BCR amplitude could be monitored stably. In the conventional method, the decrease 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. Compared with the conventional method, the BCR amplitude could be measured stably, but the stimulation electrode rarely entered 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. Compared with the conventional method, the BCR amplitude could be measured stably, but the stimulation electrode rarely escaped from the urethra of the patient.

  As described above, BCR monitoring can be performed accurately by using the electrode-attached insert according to the present invention, which is particularly beneficial when the patient is a woman or a child.

  It can be used for BCR monitoring.

100: Shaft
110: Inner pipe
120: Outer pipe
130: Hub 1
140: Second hub
200: Balloon
300: Stimulation electrode
310: First electrode
320: Second electrode
400: Mold part
500: Lead wire
600: Connection terminal
900: Insert with electrode

Claims (3)

An elongated shaft that is inserted into the urethra;
A balloon disposed near the tip of the shaft and inflatable in the bladder;
A stimulating electrode provided on the proximal side of the balloon for stimulating the pudendal nerve located in the vicinity of the bladder neck when the shaft is inserted into the urethra,
Insert with electrode used for spherical cavernous reflection monitoring.   The stimulation electrode is composed of 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 portion of the balloon and the first electrode is 10 mm. The insert with electrode according to claim 1, wherein the insert has an electrode of 20 mm.   The electrode-inserted body according to claim 2, wherein a distance between the first electrode and the second electrode is 8.0 mm to 12.0 mm.