JP2024001530A - Rectum-unique fascia proximity nerve inspection method and nerve inspection method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an inspection method and an inspection device which can inspect a nerve around a rectum and a tissue other than the nerve in a distinguished manner.

SOLUTION: An inspection method comprises: a step 1 of applying low-frequency electric stimulation to a nerve near a rectum-unique fascia 2 wrapping a rectum 1 or a tissue other than the nerve; a step 2 of making a distortion sensor 21 that detects the shape change of a balloon 11 inserted to a urinary tract 50 detect a contraction reaction of an inner urethral muscle 51; and a step 3 of determining that the object applied with the low-frequency electric stimulation is the nerve when the contraction reaction of the inner urethral muscle 51 is detected in a case where the low-frequency electric stimulation is applied to the nerve or the tissue other than the nerve, and determining that the object applied with the low-frequency electric stimulation is the tissue other than the nerve when the contraction reaction of the inner urethral muscle 51 is not detected.

SELECTED DRAWING: Figure 5

COPYRIGHT: (C)2024,JPO&INPIT

Description

The present invention relates to a nerve testing method for testing the nerve proximal to the propria rectus fascia, and a nerve testing device used for the test.

Surgery for rectal cancer will be explained based on Non-Patent Document 1. In surgery for rectal cancer, it is important to achieve both radical cure and functional preservation.
FIG. 1 (partially deformed from FIG. 1 of Non-Patent Document 1) shows a cross-sectional view of the rectum and its surrounding tissue. Surrounding the rectum 1 is the fascia propria rectum 2, a thin membrane that envelops the fat of the mesorectum. Further, Denonvilliers fascia (DVF) 3 exists on the outer periphery of the propria rectus fascia 2. The outside of DVF3 is divided into multiple membranes. Further, between the hypogastric nerve and the propria rectus fascia 2, there is an anterior hypogastric nerve fascia 5. The anterior hypogastric nerve fascia 5 lines the propria rectus fascia 2, covers the ventral side of the hypogastric nerve, forms the boundary between the pelvic nerve plexus and the propria rectum 2, and continues to the outside of the DVF 3. A nerve plexus 4, which is a collection of nerves, exists on the left side of the DVF 3 in the figure, and a part of the nerve plexus 4 exists as a hypogastric nerve 6 below the DVF 3.

The DVF3 and the prehypogastric nerve fascia5 serve as the separation layer for nerve preservation. The DVF 3 on the anterior wall and the anterior fascia of the hypogastric nerve 5 are continuous layers, and by peeling the inner side of these layers, it is possible to perform surgery that preserves the autonomic nerve while it is covered with the membrane. It is necessary to select the layer to be dissected depending on the progression of the tumor, but it is important to always be aware during surgery of which layer is being dissected, the anterior and posterior hypogastric nerve fascia5 and the DVF3. This is important to prevent damage.
In this way, in conventional rectal cancer excision surgery, when performing surgery to dissect at the intermediate position between the DVF 3 and the prehypogastric nerve fascia 5, it is necessary to determine the dissection position based on experience, which may cause damage to the nerve. It was difficult for inexperienced surgeons to perform dissection without removing the tissue.

Therefore, there is a strong desire to develop a testing method that distinguishes between nerves and fascia.
As a method for testing nerves, Non-Patent Document 2 describes that testing methods using insertion tubes with surface electrodes have become popular in recent years in order to eliminate recurrent laryngeal nerve damage during thyroid and parathyroid surgery. . A testing method is described that distinguishes between nerves and non-nerve tissues by bringing a stimulation electrode into contact with the tissue, applying electrical stimulation, and monitoring vocal cord muscle activity.
The present inventor is conducting research in the hope that such a method will be established in rectal cancer surgery as well.

Non-Patent Document 3 reports that in an experiment using female mongrel dogs, applying electrical stimulation to the hypogastric nerve caused a change in the urethral pressure response waveform.
That is, as shown in FIG. 2, a tube 102 having a balloon 103 near its tip is inserted and attached to a urethra 101 for excreting urine from a bladder 100. Then, air at a predetermined pressure is injected into the balloon 103 to inflate the balloon 103 and close the urethra. On the other hand, a first electrode 104 is connected to the hypogastric nerve, and a second electrode 105 is connected to the pudendal nerve at the front and back of the balloon.
When a low-frequency current is passed through the first electrode 104 or the second electrode 105 and electrical stimulation is applied to the pudendal nerve or hypogastric nerve, the urethra contracts, the balloon 103 is pressed, and the air pressure inside the balloon 103 is increased. Rise. Changes in air pressure are measured with a pressure gauge.
FIG. 3 shows experimental results when electrical stimulation was applied to, for example, the hypogastric nerve. In (A), a 2Hz low frequency current is passed, in (B), a 4Hz low frequency current is passed, in (C), an 8Hz low frequency current is passed, and in (D), a 10Hz low frequency current is passed. It's flowing. The graph shows changes in the internal pressure of each balloon 103. On the vertical axis of the graph, one scale is 10 mH ₂ O.

Yusuke Kinukasa Clinical Anatomy Research Group Records No. 13 2013.2 “Fascial anatomy around the rectum from a surgeon’s perspective and peeling layer for function-preserving rectal cancer surgery” Yukihito Araki, Akihiro Shioya Otorynx and Neck Volume 85 No. 8 2013.7 “Intraoperative recurrent laryngeal nerve monitoring” Takashi Shioya Journal of the Japanese Urology Society 1979; 70: 867-873 "Intraurethral pressure response to stimulation of the hypogastric and pudendal nerves"

However, it has been known that the urethra contracts by applying electrical stimulation to the pudendal nerve or hypogastric nerve, and the pressure within the urethra changes; however, the nerve plexus 14 that exists around the rectum, Since it is composed of not only a single nerve but also a plurality of nerves, it is not thought to change the intraurethral pressure, and there has been no means to monitor the nerve plexus 14 that exists around the rectum based on changes in the urethral pressure.

Therefore, it is an object of the present invention to provide an examination method and an examination apparatus that can distinguish nerves around the rectum from tissues other than nerves. purpose.

The propria rectus fascia proximal nerve testing method of the present invention has the following configuration.
(1) Step 1 of applying low-frequency electrical stimulation to the nerves or non-nerve tissues adjacent to the fascia propria rectum that surrounds the rectum, and testing means to detect changes in the shape of the balloon inserted into the urethra. , step 2 of detecting a contraction response of the internal urethra, and when the contraction response of the internal urethra is detected when the low frequency electrical stimulation is applied to the nerve or a tissue other than the nerve; , if it is determined that the target to which the low-frequency electrical stimulation was applied is the nerve, and no contraction reaction of the internal urethra is detected, it is determined that the target to which the low-frequency electrical stimulation was applied is a tissue other than the nerve; The method is characterized by comprising a step 3 of determining.

(2) In the rectal propria fascia proximal nerve testing method described in (1), if it is determined that the target to which the low-frequency electrical stimulation was applied is the nerve, warning information is output to the operator. It is characterized by having step 4.

Further, the nerve testing device used in the nerve testing method adjacent to the propria rectus fascia of the present invention has the following configuration.
(3) In the nerve testing device used in the nerve testing method near the propria rectus fascia described in (1) or (2), the testing means is integrally attached to the bladder indwelling catheter for draining the urine. It is characterized by:
(4) In the nerve testing device described in (3), the testing means includes (a) a piezoelectric sensor or a strain sensor attached to the surface of the balloon, and (b) a flow rate for measuring the amount of air flowing out from inside the balloon. (c) a pressure gauge for measuring the pressure inside the balloon; and at least one of (a), (b), and (c).

(5) In the nerve testing device described in (3), an electrical stimulation applying section for applying the low frequency electrical stimulation to the nerve or a tissue other than the nerve, and an electrical stimulation applying section for operating the electrical stimulation applying section. The electric scalpel is characterized by a switch and a switch.
(6) The nerve testing device used in the method for testing nerves adjacent to the propria rectus fascia described in (2), characterized in that a display means or sound output means for conveying the caution information is attached to the electric scalpel. shall be.
(7) The nerve testing device described in (6) is characterized in that the electric scalpel is equipped with a switch for applying the low-frequency electrical stimulation.

The propria rectus fascia proximal nerve testing method having the above configuration has the following actions and effects.
(1) Step 1 of applying low-frequency electrical stimulation to the nerves or non-nerve tissues adjacent to the fascia propria rectum that surrounds the rectum, and testing means to detect changes in the shape of the balloon inserted into the urethra. , step 2 of detecting a contraction response of the internal urethra, and when the contraction response of the internal urethra is detected when the low frequency electrical stimulation is applied to the nerve or a tissue other than the nerve; , if it is determined that the target to which the low-frequency electrical stimulation was applied is the nerve, and no contraction reaction of the internal urethra is detected, it is determined that the target to which the low-frequency electrical stimulation was applied is a tissue other than the nerve; In surgery for rectal cancer, before removing the outer periphery of the rectal fascia propria and nerves and non-nervous tissues using an electric scalpel, Electrical stimulation is applied to the object to be cut by applying a low-frequency current, and when a contraction reaction of the internal urethra is detected, the operator can determine that the object is a nerve, so there is no chance of accidentally damaging the nerve. Less afraid.
Here, since the nerve plexus 14 that exists around the rectum is far from the urethra, the amount by which the intraurethral pressure changes is small, but by directly detecting the contraction response of the internal urethral meatus, the nerve plexus 14 can be accurately and accurately detected. It can be confirmed.

When low-frequency electrical stimulation (low-frequency electrical stimulation of 100 Hz or less) is applied to the nerve, contraction of the internal urethra initially occurs. Then, as the internal urethra contracts, the balloon that is inflated in contact with the internal urethra is contracted and deformed. Then, as the balloon deflates, the air pressure inside the balloon increases, the air flows outside the body, and a pressure gauge placed outside the body measures the increase in urethral pressure.
In Non-Patent Document 3, low-frequency electrical stimulation is applied to the hypogastric nerve or pudendal nerve close to the urethra, so the internal pressure of the balloon changes relatively significantly, but the nerve near the propria rectus fascia is slightly distant from the urethra. Therefore, the response to low-frequency electrical stimulation may be weakened. Therefore, in the present invention, the outer periphery of an inflated balloon is brought into contact with the front surface of the inner periphery of the internal urethra, and when the internal urethral meatus contracts, the minute displacement of the outer periphery of the balloon is directly measured. This makes it possible to detect the contraction response of the urethra.

That is, a sensor for measuring minute displacements is attached to the outer circumference of a balloon that is inserted into the urethra. The control device stores, as an initial value, the sensor output when the balloon is inflated and the entire circumference is in close contact with the internal urethra. Then, when low-frequency electrical stimulation is applied to the tissues around the rectum, changes in the output of a sensor (for example, a strain sensor that can measure minute displacements) are used to determine whether the internal urethral meatus has caused a contraction response or not, and to determine the intraurethral pressure. Since measurement can be performed directly without any intervention, even if there is a distance from the rectum to the urethra, it is possible to accurately test whether the nerve is present or not.

(2) In the rectal fascia proximal nerve testing method described in (1), if it is determined that the target to which the low-frequency electrical stimulation has been applied is the nerve, the operator (e.g., the surgeon performing the surgery) ) is characterized in that it has a step 4 of outputting caution information for
Since the contraction response of the internal urethra is detected by the displacement of the balloon surface, the test results can be communicated to the surgeon as warning information in real time, allowing the surgeon to make quick decisions even during surgery, and reducing surgical time. It is expected that the complication rate will be reduced without prolonging the treatment.

Further, the nerve testing device used in the nerve testing method adjacent to the propria rectus fascia of the present invention having the above configuration has the following functions and effects.
(3) In the nerve testing device used in the nerve testing method near the propria rectus fascia described in (1) or (2), the testing means is integrally attached to the bladder indwelling catheter for draining the urine. Since surgery for rectal cancer requires a long time, it is performed by attaching an indwelling catheter to the patient's bladder to drain urine. At this time, by attaching the test means to the bladder indwelling catheter, the patient can perform the test without any additional physical burden.

(4) In the nerve testing device described in (3), the testing means includes (a) a piezoelectric sensor or a strain sensor attached to the surface of the balloon, and (b) a flow rate for measuring the amount of air flowing out from inside the balloon. (c) a pressure gauge for measuring the pressure inside the balloon; and at least one of (a), (b), and (c), the balloon is inflated to The pressure value measured by the piezoelectric sensor or the strain value measured by the strain sensor (strain gauge) when the piezoelectric sensor is brought into close contact with the inner periphery of the sensor is stored in the control device as an initial value. When the internal urethral meatus contracts, the contraction reaction of the internal urethra can be detected reliably and accurately by measuring minute pressure changes or minute displacements on the outer periphery of the balloon that the internal urethra is in close contact with.
Also, when the balloon deflates, air flows out from the balloon. By detecting this air outflow with a high-precision flowmeter, it is possible to reliably and precisely detect the contraction reaction of the internal urethra.
It is also possible to measure changes in urethral pressure using AQUARIUS (registered trademark) LT sold by Edap Technomed Co., Ltd.; The contraction response of the internal urethra can be detected reliably and accurately by the pressure change.

(5) The nerve testing device described in (3) is characterized in that the electric scalpel is equipped with a switch for applying the low-frequency electrical stimulation, so that the operator can check the target during surgery. By simply touching the tip of the electric scalpel to the tissue to be treated and operating the test switch, it is possible to determine whether the tissue that the electric scalpel is touching is nerve or non-nerve tissue, speeding up the surgery. And it can be done safely.

(6) The nerve testing device used in the method for testing nerves adjacent to the propria rectus fascia described in (2), characterized in that a display means or sound output means for conveying the caution information is attached to the electric scalpel. Therefore, during surgery, all of the surgeon's nerves are concentrated around the electric scalpel, but the display means or sound output indicates whether the tissue that the electric scalpel is in contact with is a nerve or a tissue other than nerves. This allows the surgery to be performed quickly and with peace of mind.

(7) The nerve testing device described in (6) is characterized in that the electric scalpel is equipped with a switch for applying the low-frequency electrical stimulation, so that the switch and the display means or the sound output means are connected to each other. Since both are provided on the electric scalpel, the operator's confirmation work can be facilitated.

FIG. 2 is a cross-sectional view of the rectum and its surrounding tissue. It is a diagram in which a tube with a balloon near its tip is inserted and attached to the urethra for excreting urine from the bladder. 3 is a diagram showing the experimental results of FIG. 2. FIG. This is a bladder indwelling catheter equipped with the nerve testing device of the present invention. (a) is an enlarged view of part A in FIG. 4, and (b) is a diagram showing a case where the strain sensors are increased to three rows, 12 locations in total. FIG. 3 is a cross-sectional view of the balloon cut at the center. 1 is a diagram showing the configuration of an electric scalpel of the present invention. FIG. 3 is an enlarged perspective view of the female part at the tip of the electric scalpel. FIG. 2 is a control configuration diagram of the present nerve testing device.

Embodiments of the method for testing the nerve near the propria rectus fascia and the nerve testing device of the present invention will be described in detail with reference to the drawings.
FIG. 4 shows a bladder indwelling catheter 10 to which the nerve testing device of the present invention is attached. The bladder indwelling catheter 10 includes a urination funnel 16 and a catheter tube 14 connected to the urination funnel 16. Further, a balloon 11 is provided near the distal end of the catheter tube 14 so as to be inflated by injecting air and tightly adhere to the inner surface of the internal urethral meatus 51 to prevent urine leakage. Although the balloon 11 shown in FIG. 4 is shown in a state in which it is inflated by injecting air, the balloon 11 is in a deflated state when it is inserted into the urethra, and after being inserted, it is inflated by injecting air. Note that FIG. 4 shows the balloon 11 in a simplified manner, and the details will be described later with reference to FIG. 5.

A urine collection tube 18 is provided at the distal end of the catheter tube 14, and an inflow hole 13 for allowing urine to flow into the urine collection tube 18 is opened in the side surface of the urine collection tube 18. The urine collection tube 18 passes through the balloon 11 and communicates with the catheter tube 14. Thereby, urine taken in from the inflow hole 13 passes through the catheter tube 14 and is discharged into a urination bag (not shown) via the urination funnel 16. A signal line 15 is attached to the catheter tube 14, and the tip of the signal line 15 is connected to a strain sensor (strain gauge) to be described later. Further, the other end of the signal line 15 is connected to the control device 12.

Next, an enlarged view of part A in FIG. 4 is shown in FIG. 5(a), and the balloon 11 will be described in detail. FIG. 4(a) shows a state in which the balloon 11 is inserted into the urethra 50, inflated by injecting air, and the outer peripheral surface of the balloon 11 is in close contact with the internal urethral meatus 51 that forms the inner surface of the urethra 50. It shows. FIG. 6 shows a cross-sectional view of the balloon 11 cut at the center.
Four strain sensors 21A, 21B, 21C, and 21D are attached to the outer circumference of the balloon 11 at intervals of 90 degrees in the circumferential direction. The strain sensors 21A, 21B, 21C, and 21D are placed in close contact with the internal urethra 51. That is, the balloon 11 is inflated by injecting air until the balloon 11 and the strain sensors 21A, 21B, 21C, and 21D expand the internal urethra 51 slightly outward.

The strain sensors 21A, 21B, 21C, and 21D detect the pressure of the balloon 11 corresponding to the internal urethral meatus 51 when the internal urethra 51 causes a contraction reaction, that is, in the circumferential direction shown by the arrow in FIG. It is arranged so that it can accurately detect when distortion occurs on the surface.
The reason why the strain sensors 21A, 21B, 21C, and 21D are attached at four locations is that the internal urethral meatus 51 does not necessarily cause a contraction reaction as a whole, but even if a contraction reaction occurs partially, it is possible to This is to enable detection. Note that it is not always necessary to attach four strain sensors, and one to three strain sensors may be attached using highly accurate strain sensors.

FIG. 5(b) shows a case where the number of strain sensors is increased to three rows, for a total of 12 locations. Since the internal urethral meatus 51 exists at specific locations in the urethra, depending on the patient, the strain sensor 21 may not be able to properly come into close contact with the internal urethral meatus 51 at four locations in one row, as shown in FIG. 5(a). There is sex. In order to avoid this, three rows of strain sensors 21A, 21B, 21C, 21D, 22A, 22B, 22C, 22D, 23A, 23B, 23C, and 23D are provided in FIG. 5(b). In this way, by providing strain sensors at 12 locations, there is an advantage that even if a contraction reaction of the internal urethra 51 occurs partially, it can be reliably detected.

Next, the electric scalpel 30 will be explained based on FIG. 7. The electric scalpel 30 is a medical device that incises and coagulates tissue by causing a high frequency current of 300 to 400 kHz to flow (arc discharge) into a person from a thin metal scalpel tip from a scalpel portion 35 at the tip. In addition to the scalpel switch 31 for electric scalpel, a testing switch 32 for neurological testing is provided in parallel. The scalpel switch 31 is used to perform surgery such as cutting the target tissue by pressing it, and the test switch 32 is a switch for applying low-frequency electrical stimulation to the target tissue by passing current through it. It is.

FIG. 8 shows an enlarged perspective view of the female part 35 at the tip of the electric scalpel 30 (an enlarged perspective view of section B in FIG. 7). A surgical electrode 36 for passing high-frequency current is provided at the center of the female part 35. An insulating resin part 37 is arranged outside the surgical electrode 36. The insulating resin part 37 is provided with a first electrode 38 and a second electrode 39 as an electrical stimulation applying part at a predetermined interval.
By pressing the test switch 32, a low frequency current flows from the first electrode 38 to the second electrode 39 via the target tissue. In this embodiment, a current of 2 Hz to 50 Hz is used as the low frequency current.
The upper part of the electric scalpel 30 shown in FIG. 7 is provided with a green LED 33 and a red LED 34 for displaying test results.

Here, in this embodiment, the surgical electrode 36 and the first electrode 38 and second electrode 39, which are test electrodes, are fixed on the same plane, but the first electrode and the second electrode are provided. The insulating resin portion 37 may be allowed to move forward and backward with respect to the surgical electrode 36 along the central axis of the surgical electrode 36. By advancing the insulating resin part 37 during an examination and retracting it during a surgery, it is possible to improve the usability of the surgical electrode 36 for a surgeon (an example of an operator).

FIG. 9 shows a control configuration diagram of the present nerve testing device. Since the bladder indwelling catheter 10 is connected to the control device 12, the first row of strain sensors 21A, 21B, 21C, and 21D are connected to the control device 12. Note that when the bladder indwelling catheter 10 includes the balloon 11 shown in FIG. 22B, 22C, 22D, and third row strain sensors 23A, 23B, 23C, 23D are connected.
Further, an electric scalpel 30 is connected to the control device 12, and a surgical electrode 36, a first electrode 38, a second electrode 39, and a green LED 33 and a red LED 34 serving as display means are connected. Further, a female switch 31 and an inspection switch 32 are connected.

Next, the operation of the nerve testing device having the above configuration will be explained.
In surgery for rectal cancer, when performing dissection at an intermediate position between the DVF 13 and the prehypogastric nerve fascia 5, the operator uses the electric knife 30 to remove the outer periphery of the rectal fascia proper and nerves and non-neural tissues. Before exfoliation, the first electrode 38 and the second electrode 39 at the tip of the electric scalpel 30 are brought into close contact with the target tissue to be cut with the electric scalpel 30, and the inspection switch 32 is pressed. This causes a low-frequency current to flow through the target tissue and provide electrical stimulation.
When the target tissue is a nerve, contraction of the internal urethra 51 occurs first. Then, as the internal urethral meatus 51 contracts, the balloon 11 that is inflated in contact with the internal urethral meatus 51 is contracted and deformed. As the balloon 11 deflates, the strain sensor 21 attached to the outer periphery of the balloon 11 detects the contraction reaction of the internal urethra 51 and outputs it to the control device 12.

When the strain sensor 21 detects a contraction reaction of the internal urethra 51, the control device 12 determines that the target tissue currently in contact with the first electrode 38 and second electrode 39 of the electric scalpel 30 is a nerve. , the red LED 34 is turned on to transmit caution information to the operator.
Further, when the strain sensor 21 does not detect a contraction reaction of the internal urethra 51, the control device 12 determines that the target tissue currently in contact with the first electrode 38 and the second electrode 39 of the electric scalpel 30 is a tissue other than nerves. When it is determined that there is, the green LED 33 is turned on to transmit safety confirmation information to the operator.
When performing dissection at an intermediate position between the DVF 3 and the anterior hypogastric nerve fascia 5, the operator can determine the dissection line that can be dissected by inspecting the tissue surrounding the area to be dissected at multiple locations. . In other words, by avoiding the tissue (nerve) where the red LED 34 is lit and determining the dissection line along the tissue other than the nerve where the green LED 33 is lit, it is possible to avoid the possibility of damaging the nerve.

In this embodiment, the strain sensor 21 is used, but other inspection means include (a) a piezoelectric sensor attached to the surface of the balloon, (b) a flow meter that measures the amount of air flowing out from inside the balloon, (c) It is also possible to use a pressure gauge that measures the pressure inside the balloon, and if necessary, these inspection means may be used in combination.
When using a piezoelectric sensor, when the balloon is inflated and brought into close contact with the inner periphery of the internal urethra 51, the pressure value measured by the piezoelectric sensor is stored in the control device as an initial value. When the internal urethral meatus 51 reacts to contraction, the contraction reaction of the internal urethral meatus 51 can be detected reliably and accurately by measuring minute pressure changes or minute displacements on the outer periphery of the balloon to which the internal urethral meatus 51 is in close contact. It is said that
Furthermore, when a flow meter is used, air flows out from the balloon when the balloon deflates. By detecting this air outflow with a high-precision flowmeter, the contraction reaction of the internal urethral meatus 51 can be detected reliably and accurately.
In addition, as a pressure gauge, it is also possible to measure changes in urethral pressure by using the AQUARIUS (registered trademark) LT sold by Edap Technomed Co., Ltd. The contraction reaction of the internal urethra 51 can be detected reliably and accurately by the change in the pressure of the air inside the balloon.

As described above in detail, the method for testing the nerve adjacent to the propria rectus fascia and the nerve testing apparatus of this embodiment provide the following effects.
(1) Step 1 of applying low-frequency electrical stimulation to nerves or tissues other than nerves adjacent to the propria rectum fascia 2 that surrounds the rectum 1, and detecting changes in the shape of the balloon 11 inserted into the urethra 50 In step 2, the test means (for example, the strain sensor 21) detects the contraction response of the internal urethra 51, and when low-frequency electrical stimulation is applied to nerves or tissues other than nerves, the internal urethra If a contraction response of 51 is detected, it is determined that the target to which low-frequency electrical stimulation was applied is a nerve, and if a contraction response of the internal urethra 51 is not detected, it is determined that the target to which low-frequency electrical stimulation was applied is other than a nerve. In surgery for rectal cancer, the outer periphery of the rectal fascia 2 and nerves and non-nervous tissues are removed using an electric scalpel 30. Before cutting the object to be cut with the electric scalpel 30, a low-frequency current is applied to the object to electrically stimulate it, and when a contraction reaction of the internal urethra 51 is detected, the operator determines that the object is a nerve. There is less risk of nerve damage caused by a mistake. Since the nerve plexus 4 that exists around the rectum is far from the urethra 50, the amount by which the intraurethral pressure changes is small, but by directly detecting the contraction response of the internal urethral meatus 51, the nerves can be confirmed accurately and accurately. can do.

When low-frequency electrical stimulation (low-frequency electrical stimulation of 100 Hz or less) is applied to the nerve, contraction of the internal urethra 51 first occurs. Then, as the internal urethral meatus 51 contracts, the balloon 11 that is inflated in contact with the internal urethral meatus 51 is contracted and deformed. Then, as the balloon 11 deflates, the air pressure inside the balloon 11 increases, air flows outside the body, and is measured by a pressure gauge installed outside the body.
In Patent Document 3, low frequency electrical stimulation is given to the hypogastric nerve or pudendal nerve near the urethra, so the internal pressure of the balloon 11 changes relatively greatly, but the nerve near the rectal fascia 2 is affected by the urethra 50. Because it is a little far from the center, the response to low-frequency electrical stimulation may be weak. Therefore, in this embodiment, the outer periphery of the inflated balloon 11 is brought into close contact with the front surface of the inner periphery of the internal urethral meatus 51, and when the internal urethral meatus 51 contracts, the minute displacement of the outer periphery of the balloon 11 is measured. By doing so, the contraction reaction of the internal urethra 51 can be detected reliably and accurately.

That is, a strain sensor 21 is attached to the outer periphery of the balloon 11 that is inserted into the urethra 50 to measure minute displacements. The control device 12 stores, as an initial value, the output of the strain sensor 21 in a state where the balloon 11 is inflated and the entire circumference is in close contact with the internal urethra 51. Then, whether or not the internal urethral meatus 51 has caused a contraction reaction is determined by changes in the output of the strain sensor 21, which can measure minute displacements when low-frequency electrical stimulation is applied to the tissues surrounding the rectum 1. Since the measurement can be performed directly without any need for a test, even if there is a distance from the rectum 1 to the urethra 50, it is possible to accurately test whether the nerve is present or not.

(2) In the rectal fascia proximal nerve testing method described in (1), if it is determined that the target to which low-frequency electrical stimulation is applied is a nerve, step 4 of outputting caution information to the operator. Since the contraction reaction of the internal urethra 51 is detected by the displacement of the surface of the balloon 11, the test results can be communicated to the operator as cautionary information in real time, so the operator can be informed even during surgery. can make quick decisions, and can be expected to reduce the complication rate without prolonging the surgical time.

Further, the nerve testing device used in the method for testing nerves adjacent to the propria rectus fascia of the present invention having the above configuration has the following effects.
(3) In the nerve testing device used in the nerve testing method near the propria rectus fascia described in (1) or (2), the strain sensor 21 serving as the testing means is integrated into the bladder indwelling catheter 10 for draining urine. Since surgery for rectal cancer requires a long time, the patient is fitted with a bladder indwelling catheter 10 for draining urine. At this time, by attaching the test means (strain sensor 21) to the bladder indwelling catheter 10, the patient can perform the test without additional physical burden.

(5) In the nerve testing device described in (3), an electrical stimulation applying section (for example, the first electrode 38 and the second electrode 39) for applying low frequency electrical stimulation to nerves or tissues other than nerves; The electric scalpel 30 is equipped with a switch (examination switch 32) for operating the electrical stimulation applying section (first electrode 38 and second electrode 39), so that the operator can Simply by bringing the tip of the electric scalpel 30 into contact with the target tissue and operating the test switch 32, it is possible to determine whether the tissue that the electric scalpel 30 is in contact with is a nerve or a tissue other than nerves. This allows surgery to be performed quickly and safely.

(6) The nerve testing device used in the method for testing the propria rectus fascia proximal nerve described in (2) is characterized in that a red LED 34 serving as a display means for conveying caution information is attached to the electric scalpel 30. Therefore, during surgery, all of the surgeon's nerves are concentrated around the electric scalpel 30, but the red LED 34 indicates whether the tissue that the electric scalpel 30 is in contact with is a nerve or a tissue other than nerves. This allows the surgery to be performed quickly and with peace of mind.
In this embodiment, the red LED 34 is used to convey caution information to the surgeon, but the control device 12 or the electric scalpel 30 may be provided with a sound output means to generate an alarm sound to convey the caution information.

(7) The nerve testing device described in (6) is characterized in that the electric scalpel 30 is equipped with a test switch 32 for applying low-frequency electrical stimulation, so that the test switch 32 and the display means are Since a certain red LED 34 is provided on both electric scalpels, the operator's confirmation work can be facilitated.

Although the method for testing the nerve near the propria rectus fascia and the nerve testing device according to the present invention have been described above, the present invention is not limited thereto, and various changes can be made without departing from the spirit thereof. be.
For example, in this embodiment, the operator memorizes the content of the operator's confirmation of each location with the electric scalpel 30 and determines the dissection line based on his/her memory, but the operator determines the dissection line using the camera. The image is stored as an image, and then the operator performs multiple examinations on nerves and non-neural tissues using the first electrode 38 and the second electrode 39, and records the examination positions and examination results. A system may be used in which the inspection results are displayed on the previously stored image and the AI computer indicates the peel line based on the inspection results.

1 Rectum 2 Fascia proper rectum 3 Denonvilliers fascia (DVF)
4 Nerve plexus 10 Bladder indwelling catheter 11 Balloon 12 Control device 21 Strain sensor 30 Electric scalpel 32 Test switch 33 Green LED
34 Red LED
35 Scalpel part 36 Surgical electrode 37 Insulating resin part 38 First electrode 39 Second electrode 50 Urethra 51 Internal urethra

Claims (7)

Step 1 of applying low-frequency electrical stimulation to nerves or tissues other than nerves adjacent to the propria rectus fascia surrounding the rectum;
a step 2 in which the testing means for detecting a change in the shape of the balloon inserted into the urethra detects a contraction response of the internal urethra;
If a contraction response of the internal urethra is detected when the low-frequency electrical stimulation is applied to the nerve or a tissue other than the nerve, the target to which the low-frequency electrical stimulation was applied is the nerve. If it is determined that there is a contraction response in the internal urethra, and a contraction response of the internal urethra is not detected, step 3 of determining that the target to which the low-frequency electrical stimulation is applied is a tissue other than the nerve;
1. A method for testing the propria rectus fascia proximal nerve. The method for testing the nerve adjacent to the propriorectalis fascia according to claim 1,
comprising step 4 of outputting caution information to an operator when it is determined that the target to which the low frequency electrical stimulation is applied is the nerve;
A method for testing the propria rectus fascia proximal nerve. In the nerve testing device used in the method for testing nerves adjacent to the propriorectalis fascia according to claim 1 or 2,
the testing means is integrally attached to a bladder indwelling catheter for draining urine;
A nerve testing device featuring: The nerve testing device according to claim 3,
The inspection means,
(a) a piezoelectric sensor and a strain sensor attached to the surface of the balloon;
(b) a flow meter that measures the amount of air flowing out from inside the balloon;
(c) a pressure gauge that measures the pressure inside the balloon;
having at least one of (a), (b), and (c);
A nerve testing device featuring: The nerve testing device according to claim 3,
an electrical stimulation applying unit for applying the low frequency electrical stimulation to the nerve or a tissue other than the nerve;
a switch for operating the electrical stimulation applying section;
that the electric scalpel is equipped with
A nerve testing device featuring: In the nerve testing device used in the nerve testing method adjacent to the propriorectalis fascia according to claim 2,
A display means or sound output means for conveying the caution information is attached to the electric scalpel;
A nerve testing device featuring: In the inspection device according to claim 6,
The electric scalpel is equipped with a switch for applying the low-frequency electrical stimulation;
A nerve testing device featuring:

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