JPWO1999002098A1 - Lesion site detection device for open surgery and laparoscopic surgery - Google Patents

Abstract

(57) [Abstract] The present invention relates to a lesion detection device for identifying lesions during open or laparoscopic surgery. Conventionally, when surgically removing lesions in organs such as the stomach or intestines, a clip is attached endoscopically during examination, and the lesion is then located by feel from the outside during surgery, or a dye is injected into the lesion during examination. These methods are unreliable and have safety issues. However, the detection device of the present invention can pinpoint a metal or magnetic clip attached endoscopically during examination from the outside using a sensor at the tip, and identify the site as the lesion. Furthermore, the device of the present invention has a shape suitable for surgical methods such as open or laparoscopic surgery.

Description

Detailed Description of the Invention

TECHNICAL FIELD The present invention relates to a lesion detection device for identifying the location of a lesion during surgery, such as when resecting a lesion such as cancer, ulcer, or polyp. Background Art Today's advances in medicine have made it possible to detect lesions such as early-stage gastrointestinal cancer, which do not cause visible changes to the normal digestive tract, such as deformation, narrowing, or color changes. Surgical procedures such as resection have been extremely life-saving. In these cases, it is important to identify the resection site during surgery. If the lesion is early and minute, for example, when it occurs on the inner wall of an organ such as the stomach or intestine, it is extremely difficult to directly identify the lesion site, even if the organ is exposed by laparotomy or laparoscopy. Therefore, to date, methods for identifying the lesion site have been subject to repeated trial and error. As a result, the dye injection identification method is currently the most commonly used method. In this method, once the lesion site is identified during an examination prior to surgery, a dye such as ink is injected into or near the lesion site to visibly mark it. Because the lesion site is marked with ink,
The ink can be used to identify the lesion during surgery. However, this method can lead to accidental injection and spraying of the ink into the abdominal cavity, making the injection site completely unidentifiable. It also carries the risk of serious infection at the injection site or within the abdominal cavity where the ink was sprayed. Furthermore, depending on the type of ink, the ink may be washed away by tissue fluid, making the injection site completely unidentifiable. Furthermore, if thick adipose tissue is present outside the injection site, the adipose tissue may obscure the injection site. These issues can lead to serious consequences for both the surgeon and the patient, such as incomplete resection or overresection. To overcome these drawbacks, a method using clips to identify the lesion site has been proposed. In this method, a clip is attached endoscopically to mark the lesion during preoperative examination. The surgeon palpates the clip during open surgery and endoscopically identifies the lesion. However, due to the small size of the clip, it has been difficult to detect the clip during surgery. In such cases, surgeons have either relied on preoperative examination findings to estimate the lesion site and proceed with surgery, or resorted to intraoperative endoscopic or intraoperative radiological examinations, which have the potential to contaminate the surgical environment. As described above, whether using ink or clips, the success of lesion detection depends on the surgeon's level of expertise. Furthermore, even experienced surgeons may be unable to identify the lesion due to external factors. For example, as mentioned above, if the lesion site is covered by fatty tissue, identifying the lesion site using ink or clips can be difficult. Thus, traditional methods for identifying the lesion site are uncertain. Failure to identify the lesion site can result in the need to perform a resurgery or the inadvertent resection of the cancerous lesion itself, leading to the dissemination of cancer cells and subsequent peritoneal dissemination and recurrence, placing a significant physical and mental burden on both the surgeon and the patient. The present invention has been made in consideration of the above-mentioned conventional problems, and aims to provide a lesion site detection device for quickly and reliably identifying a lesion site during open surgery or laparoscopic surgery. Disclosure of the Invention To achieve the above-mentioned object, the present invention comprises the following configuration: A lesion site detection device for detecting a clip attached to a lesion site from the rear surface of the lesion site, comprising: a sensor unit having a sensor at its tip that outputs a signal whose strength corresponds to the distance from the clip; and an output unit that displays and/or outputs audio according to the strength of the signal output from the sensor, the output signal of the sensor reaching a peak for clips within an area substantially covered by the tip of the sensor unit. Preferably, the clip is made of metal, and the sensor is a metal sensor that detects metal. Preferably, the clip is magnetic, and the sensor is a magnetic sensor that detects magnetism. Preferably, the output unit is housed in a housing integrated with the sensor unit, and the housing is composed of a holder including the output unit for holding by an operator, and the sensor unit. Preferably, the sensor unit has a shape that is bent at a predetermined angle near the rear end of the sensor. Preferably, the sensor unit and output unit are housed in separate housings connected by a signal line. Preferably, the sensor unit has a joint near the rear end of the sensor, and further includes a handle that bends the sensor unit to a desired angle using the joint. Best Mode for Carrying Out the Invention [First Embodiment] (Outline of the Device) In this embodiment, in order to confirm and treat the lesion using the lesion detection device according to the present invention, the lesion on the patient is endoscopically marked in advance with a metal clip. The shape of the metal clip used is not particularly important, but it must have a mass sufficient for metal detection. An example of the metal clip used is shown in Figure 4. This clip is a metal clip weighing 80m, which is conventionally used for marking.
A clip made of stainless steel or a stainless steel-titanium alloy of approximately 100 mm can also be used. Figure 1 shows the external appearance of a handheld lesion detection device 1 equipped with a metal sensor 2 at its tip. Because the device of the present invention is used inside the human body, it must be small enough to operate without interfering with its operation and have a shape that does not damage human tissue. Therefore, the detection device 1 consists of a grip portion with a diameter large enough to be held in one hand and a sensor portion equipped with a metal sensor 2 at its tip. These portions may be integrally formed from metal or resin, or may be formed separately as described below. The grip portion is held by the practitioner and houses the circuit components and power source described below. The sensor portion is elongated to allow use in narrow spaces and to make it easier for the practitioner to identify the detected area. In this embodiment, the sensor portion is cylindrical, approximately 10 mm in diameter and 150 mm in length. The entire detection device 1 has a watertight structure to prevent the intrusion of external chemicals or bodily fluids, and to prevent bacterial infection from the inside of the detection device. Here, the detection device according to the present invention will be explained based on an example of its use. If a lesion is found inside the stomach, a metal clip is attached endoscopically around the lesion during an examination prior to surgery. During open surgery, the surgeon brings the lesion detection device 1 close to the exposed outer wall of the stomach and scans along the outer wall. When the metal sensor 2 approaches the metal clip F, the array of LEDs 4 electrically connected to the output signal line of the metal sensor 2 lights up in sequence according to the degree of proximity. The surgeon can then select the LEDs that are lit.
By checking the number or position of the LEDs 4, it is possible to visually check how close the detector 1 is to the metal clip.
The distance scale 5 indicates the distance from the metal clip F, and the distance is displayed numerically. Furthermore, by connecting an electronic buzzer circuit to the output signal line of the metal sensor 2 and setting a circuit that sounds the buzzer 6 when the sensor-clip distance falls below a predetermined distance, the proximity of the metal clip F can be confirmed audibly. Furthermore, by configuring the buzzer 6 to sound intermittently at intervals corresponding to the output signal value from the metal sensor 2 or at a volume corresponding to the output signal value, the degree of proximity between the detection device 1 and the metal clip F can be determined by the degree of intermittent buzzer sound. The surgeon can confirm the resection area of the lesion based on the position of the metal clip indicated by the detection device 1, determine the resection edge, and resect the lesion. In this way, by using the detection device 1, the surgeon can perform laparotomy quickly, accurately, and safely. (Internal Configuration of the Detection Device) Figure 5 shows the circuit configuration of the detection device 1. In Figure 5, the oscillator circuit 501 is an oscillator circuit with a frequency of 100 kHz. The signal output from the oscillation circuit 501 is input to the oscillation coil 503 of the metal sensor 2. The metal sensor 2 is provided with an oscillation coil 503 made of copper wire and wound in a lap-wound manner.
3 and a receiving coil 502. The oscillator circuit 501 emits a 100 KHz signal.
When a z signal is input, an alternating magnetic field with a frequency of 100 kHz is generated from the oscillation coil 503. This alternating magnetic field generates an alternating signal with the same frequency of 100 kHz in the receiving coil 502. At this time, if there is a metal piece in the alternating magnetic field, a current is generated in the metal piece due to induced electromotive force in a direction that cancels out the change in the alternating magnetic field. This weakens the strength of the alternating magnetic field, and the level of the alternating signal generated by the receiving coil also decreases. The alternating signal generated by the receiving coil is amplified by the amplifier circuit 504 and then detected by the detection circuit 504. The detected signal strength indicates the presence or absence of metal in the alternating magnetic field. The detected signal is then input to the DC amplifier 506.
The signal is amplified and converted into a digital signal, and then used as an input signal to illuminate an LED in an LED level meter 507 according to the output level. If the signal value exceeds a predetermined level, it is also used to sound an electronic buzzer 508. Figure 6 shows the dimensions of the coil of the metal sensor unit 2 in this embodiment. The outer diameter of the winding is approximately 10 mm. The receiver coil 502 is approximately 25 mm long and has approximately 90 turns. The oscillator coil 503 is approximately 10 mm long and has approximately 30 turns wound in contact with the receiver coil near the center of the receiver coil 502. In other words, the winding ratio between the oscillator coil and the receiver coil is 1:3. Thus, the receiver coil 502 is located near the center where the magnetic flux density generated by the oscillator coil 503 is highest, and the number of turns is approximately three times that of the oscillator coil, thereby achieving sufficient sensitivity for the detection device of the present invention. A metal (iron-carbon) rod approximately 10 mm long and 30 mm long is inserted inside the coil. With the coil formed in this way, the effective range for detecting the clip through the digestive tract wall is approximately 10 mm in diameter. Although the detection accuracy increases as the diameter becomes smaller, a diameter of 10 mm is selected as a practically sufficient value. By passing an AC current through this coil, as shown in Figure 7, the magnetic flux density in the surrounding area becomes 2.0 mm in an area of approximately 20 mm in diameter and 50 mm in length centered on the oscillation coil.
An alternating magnetic field of about 100 mG is formed. Here, the detection accuracy at the tip of the sensor is not directly related to the length of the magnetic field. It is said that living organisms are affected by a magnetic flux density of about 4 mG, so the maximum must be kept below 4 mG. The magnetic field formed in this way gives the sensor 2 a structure that exhibits sharp detection characteristics at its tip, and the detection output peaks within an error range roughly equivalent to the cross section of the tip (radius of about 5 mm). Therefore, when the detection output peaks, the metal clip can be identified as being within the area covered by the tip of the sensor, and the position of the metal clip can be visualized as the position of the tip of the sensor itself. As a result,
When the output from the sensor (LED display or buzzer sound) reaches its peak, accurate treatment can be performed by performing incision or resection at the position indicated by the tip of the sensor.The detection device 1 according to the present invention is required to detect with high accuracy the position of a metal clip made of stainless steel or the like weighing about 80 mg through the stomach wall or intestinal wall.
Therefore, if the sensitivity is too high, it becomes easier to detect the metal clip, but it becomes difficult to pinpoint its location, and if the sensitivity is too low, detection itself becomes difficult. The strength of the magnetic field and the distribution of the magnetic field lines are determined based on the mass of the metal clip to be detected and the required detection accuracy, and in this embodiment, the values are as described above. Therefore, if the mass of the metal clip used or the thickness of the patient's stomach wall or intestinal wall changes significantly, it is desirable to adjust the sensitivity in accordance with these changes for more accurate position detection. To this end, a mechanism for adjusting the current flowing through the oscillation coil may be provided within the oscillator circuit 501 or between the oscillator circuit 501 and the coil. In this case, the practitioner should calibrate the detection device in advance to suit the conditions of use. Thus, the number of turns and size of the coil described above are determined based on the mass of the clip, the magnitude and strength of the generated magnetic field, and the shape of the device body. However, these values are not limited to achieve the goal of detecting the position of the metal clip with high accuracy through the stomach wall or intestinal wall. It is essential that the sensor characteristics be appropriately set to realize a sensor in which the position of the detected metal clip is generally within the range covered by the tip of the sensor. In the detection device of this embodiment, the coil is located at the tip of the sensor, and the other circuits are located in the grip. Therefore, the conductors connecting the oscillation coil 503 and the oscillation circuit 501, and the receiving coil 502 and the amplifier circuit 504, respectively, span distances of 10 cm or more. Therefore, simply passing these conductors through a hollow tube will cause interference with each other via the magnetic field generated around the conductors. In particular, if the relative positions of the conductors change, the signal detected by the detection circuit 504 will change, causing a decrease in detection accuracy and malfunction. Therefore, these conductors,
It must always be kept in a fixed state. Figure 8 is a cross-sectional view of the sensor part. The resin outer shell is filled with urethane foam, and the conductors connecting the coil, oscillation circuit, and amplifier circuit are embedded in it. This not only fixes the conductors, but also has the effect of reinforcing the long and slender sensor part, which is about 10 mm in diameter. Figure 9 shows another way of fixing the conductors. A vinyl chloride pipe 901 with an outer diameter of about 8 mm is passed through the outer shell of the main body to reinforce the main body, and the conductors 2 are inserted into it.
PVC pipes 902 and 903 with an inner diameter of about 2 mm, large enough to pass through the main body.
The inside of the pipe 901 is filled with urethane foam or the like. The wiring from the coil is
The wires are led to the circuit in the grip section through the pipes 902 and 903. This configuration not only reduces variations in detection sensitivity by holding the wires in a fixed state and improves the strength of the device body, but also makes it possible to easily repair the faulty part when a fault such as a break occurs in the coil or wiring, since the wires can be inserted and removed. With the above configuration, when lesion tissue such as cancer, ulcer, polyp, etc. is removed by laparotomy, the lesioned organ is scanned from the outside with the detection device 1,
The lesion site indicated by the pre-attached metal clip can be found accurately and reliably. This means that there are no surgical errors such as having to redo the surgery due to the lesion tissue being left behind, recurrence due to the amputation of the cancer itself, or excessive resection, allowing both the surgeon and the patient to undergo surgery with peace of mind. Furthermore, since the lesion site can be detected quickly, the surgery time can be shortened, the adverse effects of prolonged anesthesia can be avoided, and the safety of the surgery can be further improved. Furthermore, the structure of the detection device itself is very simple, so it can be provided at a low cost,
Moreover, it is small enough to be portable, and can be used intuitively by simply scanning the area around the lesion, making it extremely easy to handle. [Second embodiment] The first embodiment was a detection device suitable for use in open surgery. As the second embodiment, a detection device suitable for laparoscopic surgery will be described. The sensor unit for detecting clips and the associated circuit configuration are similar to those of the first embodiment, but the shape of the device body and the arrangement of the circuits are different. In laparoscopic surgery, the surgeon drills a hole in the abdomen of the patient and passes a tube with a diameter of about 12 mm called a trocar through the hole,
Surgical instruments are inserted into the abdominal cavity through a trocar to perform the necessary treatment. Therefore, the detection device used is also passed through the trocar. Figure 2 shows an external view of a lesion detection device 14 for laparoscopic surgery. The detection device 14 consists of a sensor unit 9 with a diameter of approximately 10 mm and a length of 300 mm, equipped with a metal sensor 7 at the tip,
It is a separate type consisting of a control unit 10 connected to the sensor unit 9 by a cable 13, and a display unit 12 further connected to the control unit 10 by a cable. The display unit is equipped with an array of LEDs, a scale 5 that indicates the distance from the clip, and a speaker 6 that also indicates the distance from the clip. The sensor unit is independent because it needs to be long enough to reach all over the abdominal cavity when passed through a trocar.
One reason is that an integrated system like the first embodiment results in poor operability. Also, laparoscopic surgery is performed while the surgeon views images taken by a camera inserted into the abdominal cavity on the abdominal monitor, so the lesion must also be confirmed on the abdominal monitor. Therefore, one reason is that it is easier to confirm the lesion site if the abdominal monitor and the display unit 12 are close to each other. Figure 3 shows a laparoscopic surgery using the detection device 14. Figure 3 shows how the sensor unit 9 is used for surgery on the stomach and intestines. The surgeon
The sensor part 9 having the metal sensor 7 at the tip is inserted into a hole in the abdominal wall by a trocar 9a.
The sensor is inserted into the sensor 7 and the lesion is searched for in the same manner as explained in the first embodiment. A metal clip is attached around the lesion beforehand at the time of the examination. Then, the array of LEDs connected to the metal sensor 7 lights up via the cable 13 and the control unit 10 according to the degree of proximity to the metal clip F, allowing the sensor sensitivity to be visually confirmed. Furthermore, by reading the distance scale 5, the distance between the sensor and the clip can be confirmed numerically. Also, when the distance between the sensor and the clip falls below a predetermined distance, a buzzer 1 sounds.
If the system is configured to sound a beep (7), the surgeon can also confirm the approach to the lesion by hearing the beep. The surgeon then confirms the resection area of the lesion, determines the resection edge, and performs the procedure while viewing the image on the display unit 12 and the laparoscope monitor 17. This not only enables accurate and safe laparoscopic surgery, but also achieves the effects described in the first embodiment. Furthermore, if the sensor unit and the control unit are separated, the signal line becomes long, making it more susceptible to noise due to external influences. Therefore, an A/D converter may be provided in the sensor unit to digitize the signal and then send the digital signal to the control unit. [Third Embodiment] Figure 11 shows the exterior of a lesion detection device 1100 according to a third embodiment of the present invention. The detection device 1100 has a structure in which a joint that can be fixed at a desired angle is added to the detection device for laparoscopic surgery in the second embodiment. Figure 11 (A)
is a diagram showing the joint in an extended state. In the figure, a sensor unit 1102 containing a metal sensor 1101 and a main body unit 1104 are rotatably secured by a rotation shaft 1103. A handle lever 1105 is also rotatably secured near the end of the main body unit 1104 opposite the sensor unit by a shaft that passes through the vicinity of the diameter of the main body unit. Both sides of the shaft of this handle lever 1105 and both sides of the shaft of the sensor unit are connected by a flexible wire or a thin string made of a material that is not easily stretched, arranged roughly along the longitudinal direction of the main body. The sensor unit 11
The sensor 1102 and the main body 1194 are covered with a cover 1106 made of flexible, watertight soft vinyl or the like, ensuring safety during use. The handle lever 1105 and the sensor 1102 are connected by a wire, so that when the user rotates the handle lever 1105 around the axis, as shown in Figures 11(B) and 11(C), the direction of the sensor changes according to the amount of rotation. If the axis 1103 is made not to rotate easily even when a small force is applied to the sensor 1102, the direction of the sensor can be maintained in the desired direction. As explained in the first embodiment, when a metal sensor is used, a magnetic field with a magnetic flux density of 2 mG is generated from the oscillation coil with a diameter of 2 mG in order to enhance the directivity of the sensor.
The generated signal has a width of approximately 0 mm and a length of approximately 50 mm. This results in a structure that exhibits sharp detection characteristics at the sensor tip. However, during laparoscopic surgery, the insertion position of the detection device is limited, so it is not always possible to scan so that the tip of the metal sensor contacts the outer wall surface of the stomach or intestine. In such cases, scanning is performed using the side of the metal sensor, reducing the clip detection accuracy and undermining the inherent benefit of the detection device of the present invention, namely, high detection accuracy. In contrast, the detection device 1100 of this embodiment has a structure that allows it to be inserted through a trocar while maintaining a straight shape, and then the angle between the metal sensor and the main body can be adjusted to a desired angle and maintained in that position. Therefore, by adjusting the orientation of the sensor so that the sensor is approximately perpendicular to the surface being scanned, scanning can be performed so that the tip of the sensor contacts the target, such as the stomach or intestine. This allows the detection device 1100 to maintain a consistently high level of detection accuracy regardless of its insertion position. Furthermore, since the detection device 1400 has a configuration in which the metal sensor part can be freely moved, it can also be used for surgery on the intestines or bladder inside the pelvis, where the insertion position of the detection device is limited.
The therapist can also move the sensor unit 1102 using the handle lever 1105.
The surface of an organ can be scanned. As described above, the lesion site detection device according to this embodiment has significantly improved operability and can further improve clip detection accuracy. [Fourth embodiment] Figure 12 shows the appearance of a detection device 1200 for laparotomy in the fourth embodiment. The detection device 1200 is basically the same as the detection device of the first embodiment in terms of electrical circuits, etc., but differs from the device of the first embodiment in two respects. First, the sensor unit 1201 has a shape that is bent at an appropriate angle. Second, the sensor unit 1201 and the main body unit 1202 can be separated. Because the sensor unit 1201 is bent at the rear part of the metal sensor, the tip of the sensor can be placed perpendicular to the surface of the object to be scanned, even if a lesion is located to the side of an organ exposed by laparotomy. This improves operability and
This allows the detection device to be used without compromising detection accuracy. This makes it suitable for situations where the location where the device can be inserted is limited, such as when there is a lesion in the intestines or bladder in the pelvis.
The tip of the sensor unit can scan the surface of an organ without being restricted by the insertion angle of the device main body, which significantly contributes to improving the accuracy of detecting lesions. Also, the coupler structure allows the sensor unit 1201 and the main body unit 1202 to be separated, making it easy to replace the probe unit. Figure 13 is a diagram showing the coupler structure. The sensor unit 1301 is provided with an electrode pin 1304 for connecting the cable drawn from the coil to the main body, and the main body 1302 is provided with an electrode pin 1304 for connecting the cable drawn from the coil to the main body.
4, and a packing 1305 that is in close contact with the sensor unit 1301 to prevent the intrusion of liquid.
The straight structure of the first embodiment and the angled structure of the present embodiment can be interchanged depending on the lesion site. In the laparoscopic detection device described in the second embodiment, the sensor unit is separate, so if the cable connecting to the control unit is made pluggable or removable, the sensor unit can be easily replaced. [Fifth Embodiment] In the first to fourth embodiments, a metal clip is attached to the lesion site and scanned by a detection device having a metal sensor unit. However, a magnetic clip can be used instead of the metal clip to indicate the lesion site and detect it. In this case, a magnetic clip with a magnetic force sufficient to respond to magnetic force measurement is used as the magnetic clip. Furthermore, a magnetic sensor is used instead of the metal sensor unit. As the magnetic sensor, a linear Hall element (SHS110, etc.) 10 is used, as shown in FIG. 10 .
By using 501, the Hall voltage corresponding to the magnetic flux density of the magnetic field in which the element is placed is measured, and the distance of the magnetic clip is determined based on this value and output as a display or sound. To use a linear Hall element, the control circuit of FIG. 5 must also be partially modified. If the current flowing through the Hall element is DC, the oscillator circuit is unnecessary, and a power supply generating DC current to be applied to the element's control electrode is provided in place of the oscillator circuit 501. A linear Hall element is used as the sensor instead of a coil. Furthermore, if the current applied to the control electrode is DC, the amplifier circuit 504 and the detector circuit 505 are unnecessary. An amplifier circuit for amplifying the Hall voltage output from the linear Hall element is required, as in FIG. 5, and its output drives the display's level meter and electronic buzzer. Note that, if AC current is applied to the control electrode of the linear Hall element, an oscillator circuit for generating the applied signal and a detector circuit for detecting the output signal are required. In this way, the magnetic sensor can also be applied to the detection devices of the first to fourth embodiments. Furthermore, a detection device combining the technologies of the above-mentioned embodiments can also be realized. That is, for each detection device that uses a metal sensor to detect a metal clip or a magnetic sensor to detect a magnetic clip, there are two configurations: an independent type (for open surgery) and a separate type (for laparoscopic surgery). The independent type is further divided into an integrated type in which the sensor unit cannot be removed, and an exchangeable type in which the sensor unit can be replaced. Furthermore, for both the independent and separate types, there is a fixed shape type in which the shape of the sensor unit is fixed, and a variable shape type in which the shape can be changed by the surgeon. Furthermore, the fixed shape type is divided into a straight type and an angled type. Finally, it should be noted that the inventor of the present application has been continuing experiments on the effectiveness of the lesion site detection device according to the present invention. As a result of these experiments, it has been found that the position of the clip can be detected at a maximum of 5 m.
The device of the present invention can reliably detect lesions with an error of about 1/2 inch, i.e., within the range of the sensor end face, and it is being confirmed that the device of the present invention has a significant effect in clinical settings. INDUSTRIAL APPLICABILITY As described above, the lesion location device of the present invention allows the surgeon to accurately and reliably locate the lesion site when cutting or resecting diseased tissue such as cancer, ulcers, polyps, etc., through open or laparoscopic surgery, without relying on the surgeon's intuition or touch, as has been the case until now. This eliminates surgical errors such as the need to redo the surgery due to leaving the lesion behind or over-resection, allowing both the surgeon and the patient to undergo surgery with peace of mind. It also contributes to shortening the surgical time. Furthermore, the lesion location device of the present invention has a simple structure, is less likely to malfunction, is inexpensive, and is extremely easy to operate.

[Brief explanation of the drawings]

FIG. 1 is a perspective view of a lesion site detection device for open surgery. FIG. 2 is a perspective view of a lesion site detection device for laparoscopic surgery. FIG. 3 is a perspective view showing the state of use of the lesion site detection device for laparoscopic surgery. FIG. 4 is a view showing the appearance of a metal clip. FIG. 5 is a view showing the circuit configuration of the lesion site detection device. FIG. 6 is a view showing the dimensions of a double coil used in a metal sensor. FIG. 7 is a view showing the state of the magnetic field generated by the coil of a metal sensor. FIG. 8 is a cross-sectional view showing the cable arrangement of the lesion site detection device. FIG. 9 is a perspective cross-sectional view showing the cable arrangement of the lesion site detection device. FIG. 10 is a view of a detection device using a magnetic sensor instead of a metal sensor. FIG. 11 is a perspective view of a lesion site detection device with a joint in the sensor unit. FIG. 12 is a perspective view of an angle-type lesion site detection device with a bent sensor unit. FIG. 13 is a perspective view showing the connection portion of a lesion site detection device with a replaceable sensor unit.

[Procedure Amendment] Submission of Translation of Amendment under Article 34 of the Patent Cooperation Treaty

[Submission date] April 2, 1999 (April 2, 1999)

[Procedural Correction 1]

[Name of document to be corrected] Statement

[Item to be amended] Claims

[Correction method] Change

[Correction details]

[Claims]

[Procedural Correction 2]

[Name of document to be corrected] Statement

[Item name to be corrected] 0003

[Correction method] Change

[Correction details]

[0003] The present invention has been made in view of the above-mentioned problems of the prior art, and aims to provide a lesion site detection device for quickly and reliably identifying the lesion site during surgery in open surgery or laparoscopic surgery. Disclosure of the Invention In order to achieve the above-mentioned object, the present invention has the following configuration: That is, a lesion site detection device comprising a probe for detecting a clip attached to a lesion site from the rear surface of the lesion site and a control unit connected by a cable , the probe comprising a sensor unit provided at its tip with a sensor that outputs a signal of an intensity according to the distance from the clip, and a conversion circuit that converts the output signal of the sensor unit.
The control unit has an output section that displays or outputs sound, or both, in response to a signal output from the conversion circuit , and the sensor has an output signal that peaks for a clip within a range substantially covered by the tip of the sensor section. Preferably, the clip is made of metal, and the sensor is a metal sensor that detects metal. Preferably, the clip is magnetic, and the sensor is a magnetic sensor that detects magnetism. Preferably, the probe has a shape that is bent at a predetermined angle near the rear end of the sensor. Preferably, the probe has a joint near the rear end of the sensor, and further includes a handle that bends the sensor section to a desired angle by the joint.

[Procedure amendment]

[Submission date] June 14, 2000 (2000.6.14)

[Procedural Correction 1]

[Name of document to be corrected] Statement

[Item name to be corrected] Full text

[Correction method] Change

[Correction details]

[Title of invention] Lesion site detection device for open surgery and laparoscopic surgery

[Claims]

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a lesion site detection device for confirming the location of a lesion during surgery, such as when resecting a lesion such as cancer, an ulcer, or a polyp.

[0002]

[Background Art] Advances in modern medicine have made it possible to detect lesions such as early-stage gastrointestinal cancer that do not cause visible changes to the normal gastrointestinal tract, such as deformation, narrowing, or changes in color, and surgical procedures such as resection have been shown to be extremely life-saving. In these cases, it is important to confirm the resection site during the procedure. If the lesion is in its early stages and is minute, and occurs on the inner wall of an organ such as the stomach or intestines, it is extremely difficult to directly confirm the lesion site, even if the organ is exposed by laparotomy or laparoscopy.

[0003] For this reason, until now, there has been repeated trial and error in determining the method for identifying the lesion site. As a result, the dye injection identification method is currently the most frequently used method. In the dye injection identification method, once the lesion site is identified during an examination prior to surgery, a dye such as ink is injected into the lesion site or its vicinity, marking the lesion site so that it can be seen. Since the lesion site is marked with ink,
The ink can be used to identify the lesion during surgery. However, this method can lead to the accidental injection and spraying of ink into the abdominal cavity, making it impossible to identify the injection site, and there is also the risk of severe infection at the injection site or within the abdominal cavity where the ink was sprayed. Furthermore, depending on the type of ink, it may be washed away by tissue fluid, making it impossible to identify the injection site. Furthermore, if there is thick fatty tissue outside the injection site, the fatty tissue may obscure the injection site. These problems can lead to incomplete resection of the lesion or excessive resection, which can be serious for both the surgeon and the patient.

[0004] A method of confirming the location of a lesion using clips has been proposed as a way to overcome these difficulties. In this method, a clip is attached to the lesion site endoscopically during an examination performed prior to surgery to mark it. The surgeon confirms the location of the lesion by touch during open surgery, and by checking the clip with an endoscope during laparoscopic surgery.

However, because the clip is so small, there have been cases where it has been impossible to find the clip during surgery. In such cases, the surgeon has had to either refer to preoperative examination findings to estimate the lesion site and then go ahead with the surgery, or perform an endoscopic examination or radiological examination during the procedure, which are likely to contaminate the surgical environment.

As described above, whether using ink or clips, the success or failure of identifying the lesion site is influenced by the practitioner's level of proficiency and skill. Furthermore, even experienced practitioners may be unable to identify the lesion site due to external factors. For example, as mentioned above, if the lesion site is covered on the outside with fatty tissue, it becomes difficult to identify the lesion site even with ink or clips.

[0007] As such, the conventional methods for identifying the lesion site are uncertain, and if the surgery has to be repeated or the cancerous lesion itself is mistakenly amputated due to the inability to identify the lesion site, it can lead to the dissemination of cancer cells and the resulting peritoneal dissemination of recurrence, which places a great physical and mental burden on not only the patient but also the surgeon.

The present invention has been made in consideration of the above-mentioned conventional problems, and aims to provide a lesion detection device for quickly and reliably identifying the lesion site during open surgery or laparoscopic surgery.

[0009]

[DISCLOSURE OF THE INVENTION] To achieve the above objectives, the present invention comprises the following components:

[0010] In other words, it is a lesion detection device comprising a probe for detecting a clip attached to a lesion site from the back side of the lesion site and a control unit connected by a cable, wherein the probe has a sensor section at its tip which has a sensor that outputs a signal of strength according to the distance from the clip, and a conversion circuit that converts the output signal of the sensor section, the control unit has an output section which displays or outputs sound, or both, according to the signal output from the conversion circuit, and the output signal of the sensor reaches a peak for clips within the range substantially covered by the tip of the sensor section.

Preferably, the clip is made of metal, and the sensor is a metal sensor that detects metal.

Preferably, the clip is magnetic, and the sensor is a magnetic sensor that detects magnetism.

Preferably, the probe has a shape that is bent at a predetermined angle near the rear end of the sensor.

Preferably, the probe further comprises a handle portion having a joint near the rear end of the sensor, the handle portion bending the sensor portion at a desired angle by the joint.

[0015]

[First embodiment] (Outline of the device) In this embodiment, in order to confirm the lesion site and perform treatment using the lesion site detection device according to the present invention, the lesion site on the patient is first marked endoscopically with a metal clip. There is no particular restriction on the shape of the metal clip to be used, but it must have a mass sufficient for metal detection. An example of the metal clip to be used is shown in Figure 4. This clip is a metal clip weighing 80 mm, which is conventionally used for marking.
It is also possible to use clips made of stainless steel or an alloy of stainless steel and titanium.

[0016] Figure 1 is an external view of a handheld lesion detection device 1 equipped with a metal sensor 2 at its tip. Because the device of the present invention is used inside the human body, it must be small enough to allow easy operation and have a shape that does not damage human tissue. Therefore, the detection device 1 consists of a grip portion with a diameter large enough to be held in one hand and a sensor portion equipped with a metal sensor 2 at its tip. Both portions may be integrally formed from metal or resin, or may be formed separately as described below. The grip portion is held by the practitioner and houses the circuit components and power source described below. The sensor portion is formed in an elongated shape to enable use in narrow spaces and to make it easier for the practitioner to identify the detected area. In this embodiment, the sensor portion is cylindrical, approximately 10 mm in diameter and 150 mm in length.

The entire detection device 1 has a watertight structure to prevent intrusion of chemicals or bodily fluids from the outside, or to prevent bacterial infection from the inside of the detection device to the human body.

[0018] Here, the detection device according to the present invention will be explained based on an example of its use. If a lesion is found inside the stomach, a metal clip is attached endoscopically around the lesion during an examination prior to surgery. During open surgery, the surgeon brings the lesion detection device 1 close to the exposed outer wall of the stomach and scans along the outer wall. When the metal sensor 2 approaches the metal clip F, the array of LEDs 4 electrically connected to the output signal line of the metal sensor 2 lights up in sequence according to the degree of proximity. The surgeon can then select the LEDs that are lit up.
By checking the number or position of the LEDs 4, it is possible to visually check how close the detector 1 is to the metal clip.
Since a distance scale 5 indicating the distance from the metal clip F is provided, the distance from the metal clip F is indicated by a numerical value.

Furthermore, if an electronic buzzer circuit is connected to the output signal line of the metal sensor 2 and a circuit is provided that sounds the buzzer 6 when the sensor-clip distance falls below a predetermined distance, it is also possible to auditorily confirm the approach of the metal clip F. Furthermore, if the buzzer 6 is configured to sound intermittently at intervals according to the output signal value from the metal sensor 2, or to sound at a volume according to the output signal value, it is possible to know the degree of approach between the detection device 1 and the metal clip F from the degree to which the buzzer sounds intermittently.

The surgeon confirms the extent of resection of the lesion, determines the cutting edge, and resects the lesion from the position of the metal clip indicated by the detection device 1. In this way, by using the detection device 1, the surgeon can carry out a quick, accurate, and safe open surgery.

[0021] (Internal Configuration of the Detection Device) Figure 5 shows the circuit configuration of the detection device 1.

5, an oscillator circuit 501 has a frequency of 100 KHz. A signal output from the oscillator circuit 501 is input to an oscillator coil 503 in the metal sensor 2. The metal sensor 2 is connected to an oscillator coil 503 made of copper wire and wound in a lap-wound manner.
3 and a receiving coil 502. The oscillator circuit 501 emits a 100 KHz signal.
When a z signal is input, an alternating magnetic field with a frequency of 100 kHz is generated from the oscillation coil 503. This alternating magnetic field generates an alternating signal with the same frequency of 100 kHz in the receiving coil 502. At this time, if there is a metal piece in the alternating magnetic field, a current is generated in the metal piece due to induced electromotive force in a direction that cancels out the change in the alternating magnetic field. This weakens the strength of the alternating magnetic field, and the level of the alternating signal generated by the receiving coil also decreases. The alternating signal generated by the receiving coil is amplified by the amplifier circuit 504 and then detected by the detection circuit 504. The detected signal strength indicates the presence or absence of metal in the alternating magnetic field. The detected signal is then input to the DC amplifier 506.
The output signal is amplified by an amplifier, converted into a digital signal, and then used as an input signal for lighting an LED in an LED level meter 507 according to the output level, and also used to sound an electronic buzzer 508 if the signal value exceeds a predetermined level.

[0023] Figure 6 shows the dimensions of the coil of the metal sensor unit 2 in this embodiment. The outer diameter of the winding is approximately 10 mm. The receiver coil 502 is approximately 25 mm long and has approximately 90 turns. The oscillator coil 503 is approximately 10 mm long and has approximately 30 turns wound in contact with the receiver coil near the center of the receiver coil 502. In other words, the winding ratio between the oscillator coil and the receiver coil is 1:3. As such, the receiver coil 502 is located near the center where the magnetic flux density generated by the oscillator coil 503 is highest, and the number of turns is approximately three times that of the oscillator coil, thereby achieving sufficient sensitivity for the detection device of the present invention. In addition, a metal (carbon-iron) rod approximately 10 mm in outer diameter and 30 mm in length is inserted inside the coil. With this coil formed in this way, the effective range for detecting a clip through the gastrointestinal wall is approximately 10 mm in diameter. Although the smaller the diameter, the higher the detection accuracy, a diameter of 10 mm is selected as a practically sufficient value.

By passing an AC current through this coil, as shown in FIG. 7, the magnetic flux density in the peripheral area becomes 2.0 in an area of about 20 mm in diameter and 50 mm in length centered on the oscillation coil.
An alternating magnetic field of about 100 mG is formed. Here, the detection accuracy at the tip of the sensor is not directly related to the length of the magnetic field. It is said that living organisms are affected by a magnetic flux density of about 4 mG, so the maximum must be kept below 4 mG. The magnetic field formed in this way gives the sensor 2 a structure that exhibits sharp detection characteristics at its tip, and the detection output peaks within an error range roughly equivalent to the cross section of the tip (radius of about 5 mm). Therefore, when the detection output peaks, the metal clip can be identified as being within the area covered by the tip of the sensor, and the position of the metal clip can be visualized as the position of the tip of the sensor itself. As a result,
When the output from the sensor (LED display or buzzer sound) reaches a peak, accurate treatment can be performed by performing incision or excision at the position indicated by the tip of the sensor.

[0025] The detection device 1 according to the present invention is required to detect the position of a metal clip made of stainless steel or the like weighing about 80 mg with high accuracy through the stomach wall or intestinal wall.
Therefore, if the sensitivity is too high, it becomes easier to detect the metal clip, but it becomes difficult to pinpoint its location, and if the sensitivity is too low, detection itself becomes difficult. The strength of the magnetic field formed and the distribution of the magnetic field lines are determined based on the mass of the metal clip to be detected and the required detection accuracy, and in this embodiment, the values are as described above. Therefore, if the mass of the metal clip used or the thickness of the patient's stomach wall or intestinal wall changes significantly, it is desirable to adjust the sensitivity in accordance with these changes for more accurate position detection. To this end, a mechanism for adjusting the current flowing through the oscillation coil may be provided within the oscillation circuit 501 or between the oscillation circuit 501 and the coil. In this case, the practitioner should pre-calibrate the detection device to suit the conditions of use.

[0026] As described above, the number of turns and size of the coil are determined based on the mass of the clip, the size and strength of the generated magnetic field, and the shape of the device body, but are not limited to these values in order to achieve the purpose of detecting the position of the metal clip with high accuracy through the stomach wall or intestinal wall. It is important to appropriately set the characteristics of the sensor so that the detected position of the metal clip is generally within the range covered by the tip of the sensor part.

In the detection device of this embodiment, the coil is located at the tip of the sensor, and the other circuits are located in the grip. Therefore, the conductors connecting the oscillation coil 503 and the oscillation circuit 501, and the receiving coil 502 and the amplifier circuit 504, respectively, span a distance of 10 cm or more. Therefore, if these conductors are simply passed through a hollow tube, they will interfere with each other via the magnetic field generated around the conductors. In particular, if the relative positions of the conductors change, the signal detected by the detection circuit 504 will change, causing a decrease in detection accuracy and malfunction. Therefore, these conductors,
It must always be kept fixed.

[0028] Figure 8 is a cross-sectional view of the sensor unit. The resin outer shell is filled with urethane foam, within which conductors connecting the coil, oscillator circuit, and amplifier circuit are embedded. This not only secures the conductors but also reinforces the long and slender sensor unit, which is about 10 mm in diameter.

9 shows another way of fixing the conductor wire. A vinyl chloride pipe 901 with an outer diameter of about 8 mm is inserted inside the outer shell of the main body to reinforce the main body.
PVC pipes 902 and 903 with an inner diameter of about 2 mm, large enough to pass through the main body.
The inside of the pipe 901 is filled with urethane foam or the like. The wiring from the coil is
The wires are led to the circuit in the grip section through pipes 902 and 903. This configuration not only reduces variations in detection sensitivity and improves the strength of the device body by holding the wires in a fixed state, but also makes it easy to repair the faulty part in the event of a break or other malfunction in the coil or wiring, since the wires can be easily inserted or removed.

With the above-described configuration, when lesion tissue such as cancer, ulcer, polyp, etc. is removed by abdominal surgery, the detection device 1 scans the lesioned organ from the outside,
The lesion site, indicated by the pre-attached metal clip, can be found accurately and reliably. This eliminates surgical errors such as the need to redo the operation due to leftover lesion tissue, recurrence due to amputation of the cancer itself, and over-resection, allowing both the surgeon and patient to undergo surgery with peace of mind. Furthermore, since the lesion site can be detected quickly, the surgery time can be shortened, the adverse effects of prolonged anesthesia can be avoided, and surgical safety can be further improved.

Furthermore, the detection device itself has a very simple structure and can be provided at low cost.
Moreover, it is small enough to be portable and can be used intuitively by simply scanning the area around the lesion, making it extremely easy to handle.

[Second embodiment] The first embodiment was a detection device suitable for use in open surgery. As the second embodiment, a detection device suitable for laparoscopic surgery will be described. The sensor unit for detecting clips and the associated circuit configuration are similar to those of the first embodiment, but the shape of the device body and the layout of the circuit are different. In laparoscopic surgery, the surgeon pierces the abdomen of the patient and passes a tube with a diameter of about 12 mm called a trocar through the hole,
Surgical instruments are inserted into the abdominal cavity through the trocar to perform the necessary procedures, and the detection device used is also passed through the trocar.

2 shows an external view of a lesion site detection device 14 for laparoscopic surgery. The detection device 14 includes a sensor unit 9 having a diameter of about 10 mm and a length of about 300 mm and equipped with a metal sensor 7 at the tip thereof.
It is a separate type consisting of a control unit 10 connected to the sensor unit 9 by a cable 13, and a display unit 12 further connected to the control unit 10 by a cable. The display unit is equipped with an array of LEDs, a scale 5 that indicates the distance from the clip, and a speaker 6 that also indicates the distance from the clip. The sensor unit is independent because it needs to be long enough to reach all over the abdominal cavity when passed through a trocar.
One reason is that an integrated system like the first embodiment results in poor operability. Another reason is that laparoscopic surgery is performed while the surgeon views images taken by a camera inserted into the abdominal cavity on the abdominal monitor, so the lesion must also be confirmed on the abdominal monitor. Therefore, it is easier to confirm the lesion when the abdominal monitor and display unit 12 are located close to each other.

[0034] Fig. 3 shows a state of laparoscopic surgery using the detection device 14. Fig. 3 shows a state in which the sensor unit 9 is used for surgery on the stomach and intestines.
The sensor part 9 having the metal sensor 7 at the tip is inserted into a hole in the abdominal wall by a trocar 9a.
The sensor is inserted into the metal sensor 7 and the lesion is searched for in the same manner as explained in the first embodiment. A metal clip is attached around the lesion beforehand at the time of the examination. Then, the array of LEDs connected to the metal sensor 7 lights up according to the degree of proximity to the metal clip F via the cable 13 and the control unit 10, allowing the sensor sensitivity to be visually confirmed. Furthermore, by reading the distance scale 5, the distance between the sensor and the clip can be confirmed numerically. Also, when the distance between the sensor and the clip falls below a predetermined distance, a buzzer 1 sounds.
If the laparoscope is configured to sound the alarm 7, the surgeon can also confirm by hearing the sound that the surgeon is approaching the lesion. The surgeon can then confirm the extent of resection of the lesion and determine the resection edge while viewing the image on the display unit 12 and the laparoscope monitor 17. This allows for accurate and safe laparoscopic surgery, and also achieves the effects described in the first embodiment.

[0035] If the sensor section and the control unit are separated, the signal line will be long and noise will be more likely to occur due to external influences. For this reason, an A/D converter may be provided in the sensor section to digitize the signal and then send the digital signal to the control unit.

[Third embodiment] Figure 11 is a diagram showing the appearance of a lesion site detection device 1100 according to a third embodiment of the present invention. The detection device 1100 has a structure in which a joint that can be fixed at a desired angle is provided in the detection device for laparoscopic surgery according to the second embodiment.
is a diagram showing the joint in an extended state. In the figure, a sensor unit 1102 containing a metal sensor 1101 and a main body unit 1104 are rotatably secured by a rotation shaft 1103. A handle lever 1105 is also rotatably secured near the end of the main body unit 1104 opposite the sensor unit by a shaft that passes through the vicinity of the diameter of the main body unit. Both sides of the shaft of this handle lever 1105 and both sides of the shaft of the sensor unit are connected by a flexible wire or a thin string made of a material that is not easily stretched, arranged roughly along the longitudinal direction of the main body. The sensor unit 11
The nozzle 1102 and main body 1194 are covered with a cover 1106 made of soft vinyl or the like which is flexible and highly watertight, ensuring safety during use.

11B and 11C, when the user rotates the handle lever 1105 around the axis, the orientation of the sensor unit changes according to the amount of rotation. If the axis 1103 is made not to rotate easily even when some force is applied to the sensor unit 1102, the orientation of the sensor unit can be maintained in the desired direction.

As explained in the first embodiment, when a metal sensor is used, a magnetic field with a magnetic flux density of 2 mG is generated from the oscillation coil in a diameter of 2 mG in order to enhance the directivity of the sensor.
The signal is generated so as to have a region of approximately 0 mm in length and 50 mm in length. This results in a structure that exhibits sharp detection characteristics at the tip of the sensor. However, during laparoscopic surgery, the position at which the detection device can be inserted is limited, and it is not always possible to scan so that the tip of the metal sensor comes into contact with the outer wall surface of the stomach or intestine. In such cases, scanning is performed using the side of the metal sensor, which reduces the clip detection accuracy and undermines the original effect of the detection device of the present invention, which is high detection accuracy.

In contrast, the detection device 1100 of this embodiment has a structure that allows it to be inserted through a trocar while maintaining a straight shape, and then the angle between the metal sensor unit and the main body can be adjusted to a desired angle and maintained in that position. Therefore, by adjusting the direction of the sensor unit so that it is roughly perpendicular to the surface to be scanned, it is possible to perform scanning so that the tip of the sensor is in contact with the target to be scanned, such as the stomach or intestines. Therefore, regardless of the position where the detection device 1100 is inserted, it is possible to maintain a high level of detection accuracy.

[0040] In addition, since the detection device 1400 has a configuration in which the metal sensor part can be freely moved, it can also be used for surgery on the intestines or bladder inside the pelvis, where the insertion position of the detection device is limited.
The therapist can also move the sensor unit 1102 using the handle lever 1105.
The surface of the organ can be scanned.

As described above, the lesion site detection device according to this embodiment has significantly improved operability and can further improve the accuracy of clip detection.

[Fourth Embodiment] Figure 12 shows the appearance of a detection device 1200 for abdominal surgery in the fourth embodiment. The detection device 1200 is basically the same as the detection device of the first embodiment in terms of electrical circuits, etc., but differs from the device of the first embodiment in two respects. First, the sensor unit 1201 has a shape that is bent at an appropriate angle. Second, the sensor unit 1201 and the main body unit 1202 can be separated.

Since the sensor unit 1201 is bent at the rear of the metal sensor, even if there is a lesion on the side of the organ exposed by laparotomy, the tip of the sensor can be placed perpendicular to the surface of the object to be scanned. This improves operability and
This allows the detection device to be used without compromising detection accuracy. This makes it suitable for situations where the location where the device can be inserted is limited, such as when there is a lesion in the intestines or bladder in the pelvis.
The tip of the sensor can scan the surface of an organ without being restricted by the insertion angle of the device body, which significantly contributes to improving the accuracy of detecting lesions.

[0044] Furthermore, since the coupler structure allows the sensor unit 1201 and the main body unit 1202 to be separated, the probe unit can be easily replaced. Figure 13 shows the coupler structure. The sensor unit 1301 is provided with an electrode pin 1304 for connecting the cable drawn from the coil to the main body, and the main body 1302 is provided with an electrode pin 1304 for connecting the cable drawn from the coil to the main body.
4, and a packing 1305 that is in close contact with the sensor portion 1301 to prevent the intrusion of liquid.

In this way, by making the sensor unit replaceable, the sensor unit can be
The straight structure of the first embodiment and the angled structure of the present embodiment can be used interchangeably depending on the lesion site.

[0046] In addition, since the detection device for laparoscopy described in the second embodiment has a separate sensor unit, the sensor unit can be easily replaced if the cable for connecting to the control unit is made pluggable or removable using a plug or the like.

In the first to fourth embodiments, a metal clip is attached to the lesion and the metal clip is scanned by a detection device having a metal sensor unit. However, a magnetic clip may be used instead of the metal clip to indicate the lesion, and the magnetic clip may be detected.

In this case, a clip having a magnetic quantity that is sufficiently responsive to magnetic force measurement is used as the magnetic clip. Also, a magnetic sensor is used instead of the metal sensor part. As the magnetic sensor, a linear Hall element (SHS110 or the like) 10 is used as shown in FIG.
By using 01, the Hall voltage corresponding to the magnetic flux density of the magnetic field in which the element is placed is measured, and the distance of the magnetic clip is determined based on the value and output as a display or sound.

To use a linear Hall element, the control circuit in FIG. 5 must also be partially modified. If the current flowing through the Hall element is DC, the oscillator circuit is unnecessary, and a power supply that generates a DC current to be applied to the control electrode of the element is provided in place of the oscillator circuit 501. A linear Hall element is used as the sensor instead of a coil. Also, if the current applied to the control electrode is DC, the amplifier circuit 504 and the detector circuit 505 are unnecessary. As in FIG. 5, an amplifier circuit that amplifies the Hall voltage output from the linear Hall element is necessary, and its output drives the level meter and electronic buzzer in the display unit. Note that, if an AC current is applied to the control electrode of the linear Hall element, an oscillator circuit for generating the signal to be applied and a detector circuit for detecting the output signal are required.

In this way, the magnetic sensor can also be applied to the detection devices of the first to fourth embodiments.

[0051] It is also possible to realize a detection device that combines the technologies of the above-described embodiments. That is, for detection devices that use a metal sensor for detecting metal clips or a magnetic sensor for detecting magnetic clips, there are two configurations: an independent type (for open surgery) and a separate type (for laparoscopic surgery). The independent type is further divided into an integrated type in which the sensor unit cannot be removed, and an exchangeable type in which the sensor unit can be exchanged. Furthermore, for both the independent type and the separate type, there is a fixed-shape type in which the shape of the sensor unit is fixed, and a variable-shape type in which the shape can be changed by the surgeon. The fixed-shape type is further divided into a straight type and an angled type.

Finally, the inventors of the present invention have been conducting experiments on the effectiveness of the lesion site detection device according to the present invention. As a result of these experiments, it has been found that the clip position can be adjusted by 5 m at most.
It is possible to reliably detect within an error of about 1 m, that is, within the range of the sensor end face, and it is being confirmed that the device of the present invention is extremely effective in clinical settings.

[0053]

[Effects of the Invention] As explained above, the lesion site detection device of the present invention allows the surgeon to accurately and reliably locate the lesion site when cutting or resecting diseased tissue such as cancer, ulcers, polyps, etc., through open surgery or laparoscopic surgery, without relying on the surgeon's intuition or touch, as has been the case until now. This completely eliminates surgical errors such as the need to redo the surgery due to leaving a lesion behind or over-resection, allowing both the surgeon and the patient to undergo surgery with peace of mind. It also contributes to shortening the surgery time.

Furthermore, the lesion site detection device of the present invention has a simple structure, is less prone to malfunction, is inexpensive, and is extremely easy to operate.

[Brief explanation of the drawings]

FIG. 1 is a perspective view of a lesion site detection device for open surgery.

FIG. 2 is a perspective view of a lesion site detection device for laparoscopic surgery.

FIG. 3 is a perspective view showing the state of use of the lesion site detection device for laparoscopic surgery.

FIG. 4 is a diagram showing the appearance of a metal clip.

FIG. 5 is a diagram showing the circuit configuration of the lesion site detection device.

FIG. 6 is a diagram showing the dimensions of a double coil used in a metal sensor.

FIG. 7 is a diagram showing the state of a magnetic field generated by a coil of a metal sensor.

FIG. 8 is a cross-sectional view showing the arrangement of cables of the lesion site detection device.

FIG. 9 is a perspective cross-sectional view showing the arrangement of cables of the lesion site detection device.

FIG. 10 is a diagram of a detection device using a magnetic sensor instead of a metal sensor.

FIG. 11 is a perspective view of a lesion site detection device having a joint in the sensor unit.

FIG. 12 is a perspective view of a lesion site detection device with an angled sensor section.

FIG. 13 is a perspective view showing the connection portion of a lesion site detection device in which the sensor unit is replaceable.

───────────────────────────────────────────────────── (Note) This publication is based on the publication published internationally by the International Bureau of Patents (WIPO). The effect of the international publication of the Japanese patent application (Japanese utility model registration application) related to this publication arises pursuant to Article 184-10, Paragraph 1 of the Patent Act (Article 48-13, Paragraph 2 of the Utility Model Act) and is unrelated to this publication.

Claims (9)

[Claims] [Claim 1] A lesion site detection device for detecting a clip attached to a lesion site from the back side of the lesion site, comprising: a sensor unit having a sensor at its tip that outputs a signal of strength according to the distance from the clip; and an output unit that performs either a display or an audio output, or both, according to the strength of the signal output from the sensor, wherein the output signal of the sensor reaches a peak for clips within a range substantially covered by the tip of the sensor unit. [Claim 2] A lesion detection device comprising: a clip that can be attached to a lesion site; a sensor unit having a sensor at its tip that outputs a signal of a strength corresponding to the distance from the clip; and an output unit that displays or outputs sound, or both, according to the strength of the signal output from the sensor, wherein the output signal of the sensor reaches a peak for clips within a range substantially covered by the tip of the sensor unit. 3. The lesion site detection device according to claim 1, wherein the clip is made of metal, and the sensor is a metal sensor that detects metal. 4. The lesion site detection device according to claim 1, wherein the clip is magnetic and the sensor is a magnetic sensor that detects magnetism. [Claim 5] A lesion site detection device as described in claim 1 or 2, characterized in that the output unit and the sensor unit are contained in a housing that integrates them, and the housing is composed of a holding unit including the output unit for being held by an operator, and the sensor unit. 6. The lesion site detection device according to claim 5, wherein the sensor section has a shape that is bent at a predetermined angle near the rear end of the sensor. 7. The lesion site detecting device according to claim 1, wherein the sensor section and the output section are housed in separate housings. [Claim 8] A lesion site detection device as described in Claim 7, characterized in that the sensor unit has a joint portion near the rear end of the sensor, and further comprises a handle portion that bends the sensor unit to a desired angle using the joint. [Claim 9] A lesion detection device as described in Claim 3, characterized in that the sensor unit generates a magnetic field along its longitudinal direction in an area approximately 20 millimeters in diameter, with a magnetic flux density of approximately 2 milligauss near the boundary of the area.