WO2010041714A1

WO2010041714A1 - Surgery system for endoscopic submucosal dissection (esd) and surgery method

Info

Publication number: WO2010041714A1
Application number: PCT/JP2009/067562
Authority: WO
Inventors: 猛大平
Original assignee: 学校法人自治医科大学
Priority date: 2008-10-10
Filing date: 2009-10-08
Publication date: 2010-04-15
Also published as: JP5403433B2; JPWO2010041714A1

Abstract

Provided is a surgery system and a surgery method for ESD excellent in operability, safety and reliability of surgery with reduction of time spent in surgery and surgical invasion. The surgery system for ESD includes magnetic anchors (20, 20’, 20’’, 22A, 22B) composed of an engaging member (21) engaged with a lesion region (T2a) of the inner surface of a human body tract (T) and small-diameter magnetic members (22, 22’, 22’’, 22A, 22B) connected with one another, a magnetic flux radiating means (10, 10a, 10b) mounted in the end (41) of the endoscope to be inserted into the vicinity of the legion region of the human body tract and having hermetically-sealed magnetism producing elements (15, 15A, 15B, 16) to give electromagnetic repelling forces to the magnetic anchors, and a magnetic flux control means (70) provided to the outside of the human body for controlling from the outside the distribution of the magnetic flux radiated from the magnetic flux radiating means. The magnetic flux control means (70) controls, from the outside, the distribution of the magnetic flux radiated from the magnetic flux radiating means so as to give electromagnetic repelling forces to the magnetic anchors, and the lesion region engaged with the engaging member is pulled in the direction of removal from the muscle layer (T1) of the human body tract.

Description

Surgical system and surgical method for endoscopic submucosal dissection (ESD)

The present invention relates to an endoscopic submucosal dissection (ESD) surgical system and a surgical method for resecting a lesion in a living organism's biological duct, and in particular, excising a lesion such as early gastrointestinal cancer. The present invention relates to an ESD surgical system and a surgical method for raising a lesion part to be excised in an arbitrary direction to secure a field of view by an endoscope and easily peeling a lower layer of the lesion part.

Conventionally, the lesion of early gastrointestinal cancer has been excised using an endoscope that inserts an insertion sheath into the digestive tract such as the gastrointestinal tract. In this early gastrointestinal cancer resection, in addition to endoscopic mucosal resection (EMR), high-frequency knives such as IT knives, flex knives and hook knives are used to remove large lesions. ESD that exfoliates the diseased mucosa is widespread.

In this ESD, since the gastric wall perforation rate of puncturing the stomach by endoscopic surgery is as high as several percent, it is an issue to safely remove the lesion. For this reason, when excising a lesion such as early gastrointestinal cancer, injecting physiological saline between the submucosal layer and the muscular layer to raise the lesion, incision of the submucosa using a snare or a high-frequency knife, Peeling has been done.

However, when the lesion is raised by locally injecting physiological saline as described above, it is necessary to raise the lesion sufficiently for incision and peeling of the lesion. Over time, the mucous membrane protuberance formed artificially by diffusing into the submucosa layer gradually became flat, and there was a problem that the risk of perforating the muscle layer increased. Therefore, when excising the lesion, if the saline injected locally diffuses and the mucosal ridge becomes flat, the saline can be injected again locally, or hyaluronic acid with high water retention capability can be injected locally. However, various methods have been tried to increase the distance between adjacent muscle layers or normal tissues by using other means together.

As a first example of such a conventional method, as shown in FIG. 17, in order to make a lesion easily peelable, a magnetic anchor guide for lifting a lesion using a magnetic anchor 164 provided with a clip 162 is used. A device has been proposed. (For example, refer to Patent Document 1).

In the following description, with respect to the natural opening portion of the living body or the living body portion for the endoscope which is opened separately, the in-vivo direction equipment or the portion of the living tube is referred to as the “tip” or “front portion”, The part of the equipment or the biological tube is called “rear end” or “rear part”.

The magnetic anchor guide device of the first example includes a clip 162 attached to a lesioned part 161, a magnetic anchor 164 attached to the clip 162 via a connecting part 163, and a driving force to the magnetic anchor 164 from outside the body. A magnetic derivative 165 to be provided. This magnetic anchor guiding device lifts the lesioned part 161 by the following operation. First, similarly to the conventional method, the lesion 161 is raised by injecting physiological saline 167 into the lower part of the lesion 161 using the endoscope 166. Next, the clip 162 is attached to the lesion 161 with the grasping forceps 168. Next, the endoscope 166 is pulled out, the magnetic anchor 164 is attached to the grasping forceps 168, the endoscope 166 is inserted again, and the magnetic derivative 165 outside the body is operated to fix the magnetic anchor 164 at a predetermined position of the affected part.

Thereafter, the endoscope 166 is pulled out, the connecting portion 163 is attached to the grasping forceps 168, the endoscope 166 is inserted again, one end of the connecting portion 163 is attached to the clip 162 in the affected area, and the other end of the connecting portion 163 is magnetically connected. Attach to anchor 164. In this state, the lesioned part 161 can be lifted by operating the magnetic derivative 165 from the outside and pulling the clip 162, and in this state, the lesioned part can be safely excised with an IT knife or the like.

As a second conventional example, as shown in FIG. 18, a guide sheath 173 having one endoscope channel 171 and two treatment instrument guide insertion instrument channels 172 is used, and two treatment instruments are used. An electric knife 177 passed through an endoscope 176 inserted from one endoscope channel 171 is lifted up by a two

forceps

174 and 175 inserted from the guide insertion tool channel 172, respectively. An endoscopic treatment apparatus for excising the lesion is proposed. (For example, refer to Patent Document 2).

Further, as a conventional third example, as shown in FIG. 19, a pair of freely openable / closable claw portions 112 having distal ends facing each other and coupled at a base portion and a pair of claw portions 112 inserted therein are inserted. A presser ring 116 that closes the claw part 112 provided so as to be relatively movable along the pair of claw parts 112, and a base part of the pair of claw parts 112 are detachably engaged with each other. In the endoscopic treatment instrument comprising: a gripping tool 111 comprising a connecting plate (not shown); and an ultrathin thread 115 connected to the base of the pair of claws 112 and extending through the presser ring 116. A flexible sheath 129 whose portion is bent by a predetermined angle is attached to the endoscope 132, and passes through all of the plurality of ultrafine threads 115 extending from the distal end of the flexible sheath 129 to the outside from the forceps insertion port. Not shown The flexible sheath 129, which is taken out from the slider side opening of the tube joint at the end and bent at the distal end, is inserted again from the forceps insertion opening of the endoscope 132, and the flexible sheath 129 is bent at the distal end. The distal end of the endoscope protrudes from the forceps hole 137 of the endoscope 132. Next, by rotating the tube joint, the distal end portion of the flexible sheath 129 having a bent distal end portion is separated from the lesioned portion 151 of the mucosal layer 153 in the digestive organ, that is, the distal end portion of the flexible sheath 129. Is located in the direction in which the lesioned part 151 is to be raised. In this state, when each ultrafine thread 115 is pulled from outside the body, the lesioned portion 151 is raised upward in a tent shape. Therefore, a method has been proposed in which an IT knife 157 is inserted from another forceps insertion port 138 of the endoscope 132 to incise and remove the lesioned portion 151. (For example, refer to Patent Document 3).

Further, as a conventional fourth example, as shown in FIG. 20, a clip 210 that grips a body tissue lesion 251 by an operation outside the body and a normal body tissue marking unit that faces the lesion 251 by another clip 216. Two lifting clips 201 each having an engaging portion 230 for holding 252 and an elastic member 221 connected to each other and a connecting portion 220 for connecting the clip 210 and the engaging portion 230 at a predetermined length are used. The two

lesioned portions

251a and 251b are gripped, and the lesioned portion 251 is pulled in the opposite direction by the tension of the elastic member 221, and the

lesioned portions

251a and 251b are held in a state of being separated from the digestive tract wall 250. In this state, a medical treatment instrument has been proposed in which an electronic knife 260 is inserted into a forceps channel in an endoscope (not shown) and the submucosal layer 253 of the lesioned portion 251 is peeled off (see, for example, Patent Document 4). In this case, the clip 210, the connecting portion 220, and the engaging portion 230 have a shape that can be inserted into clip forceps of an endoscope (not shown).

Furthermore, as a fifth conventional example, as shown in FIG. 21, a cylinder that is formed in a cylindrical shape and is provided with a slit (not shown) that extends along the central axis in the upper surface, and is attached to the distal end of the endoscope En. A portion 303 and a capture portion 305 that extends along the slit and is disposed in the tube portion 303 and holds the tissue (lesioned portion) in the digestive tract with respect to the endoscope En. A pair of

forceps pieces

308A and 308B pivotally supported by 308, an operation portion (not shown) for opening and closing the pair of

forceps pieces

308A and 308B via an operation wire (not shown), and flexibility for allowing the operation wire to be inserted in a freely retractable manner Proposal of an endoscopic treatment device including a sheath 312 having a moving part 321 and a moving part 321 that moves the capturing part 305 and moves the holding position of the tissue (lesioned part) in the digestive tract with respect to the tubular part 303 Has been (For example, see Patent Document 5).

The moving part 321 is connected to a hood (first position) 306 on the proximal end side of the cylindrical part 303 and allows the sheath 312 of the capturing part 305 to be inserted into the cylindrical part 303 so as to be movable forward and backward, while moving in the radial direction. A supporting portion 322 for regulating, and extending along the capturing portion 305, one end of which is pivotally supported by a first rotating shaft 323 on a cap (second position) 307 of the cylindrical portion 303 on the tip side of the hood 306, and The other end is provided with a link member (connecting portion) 326 pivotally supported by a second rotating shaft 325 disposed on the tip cover 308 of the capturing portion 305.
JP 2004-105247 A JP 2000-325303 A JP 2007-143869 A Japanese Patent Laid-Open No. 2008-62004 JP 2008-173369 A

However, the conventional magnetic anchor guiding device described in Patent Document 1 cannot be operated by the ESD surgeon when operating the magnetic derivative 165 from the outside, so that another person follows the instruction of the ESD surgeon. There is a problem that it is necessary to operate, and the operation is complicated and time-consuming.

Further, the conventional endoscope treatment apparatus described in Patent Document 2 has a configuration in which a lesioned part is lifted by two

forceps

174 and 175 inserted from two treatment tool guide insertion tool channels 172, respectively. Therefore, the operation of the two

forceps

174 and 175 and the ESD surgical operation with the electric knife 177 cannot be performed simultaneously by the same person, and the operation according to the instruction of the ESD surgeon by another person is complicated and time-consuming. Since the outer diameter of the guiding sheath 173 increases as the number of treatment instrument guide insertion tool channels increases, there are problems such as increased patient pain.

In addition, the conventional endoscopic treatment apparatus described in Patent Document 3 can simultaneously perform an operation of pulling a plurality of ultrafine threads 115 to lift a lesioned part and an ESD surgical operation using an IT knife 157 by the same person. There is a problem that the operation is complicated and time-consuming.

In addition, the conventional medical treatment apparatus described in Patent Document 4 uses two lifting clips 201 by an operation from outside the body, and uses two

lesions

251a and 251b and a lesion 251 in the lesion 251 in the digestive tract 250. Therefore, there is a problem in that it is difficult to perform the ESD surgical operation by the same person at the same time because the operation for grasping the two portions in the vicinity of the marking portion 252 of the tissue in the normal gastrointestinal tract 250 facing is difficult.

In addition, the conventional endoscopic treatment device described in Patent Document 5 simultaneously performs an operation for holding a lesion in the digestive tract by the capture unit 305 and an ESD surgical operation using an electric scalpel by an operation from outside the body by the same person. In addition, the operation is complicated and troublesome, and the outer diameter of the endoscope distal end portion is increased by the amount of the tube portion 303 and the capture portion 305 mounted thereon, resulting in increased patient pain. is there.

In addition to the above problems, various means for grasping and lifting the lesion in the digestive tract proposed in the conventional patent documents 1 to 5 ensure that the ESD surgeon sufficiently secures the field of view through the endoscope. During surgery, it is necessary to instantaneously raise the lesion in any direction depending on the situation, but in any case, it is almost impossible for the ESD surgeon himself to instantly pull up the lesion in any direction. There is a problem that has become a simple structure.

For this reason, in the conventional ESD surgical apparatus proposed in the above-mentioned patent documents and the like, the ESD surgeon cannot sufficiently secure the field of view by the endoscope according to the situation during the operation. There remains a substantial problem that the surgical invasion is excessive for the patient, such as high risk of perforating the inner muscle layer, requiring sufficient skill, and time-consuming ESD surgery.

Therefore, the present invention has been made in view of the above-described problems of the prior art, and an object of the present invention is to reduce the operation time and surgical invasion, and is excellent in operability, safety and reliability of surgery. A surgical system and a surgical method are provided.

In order to achieve the above object, a surgical system for endoscopic submucosal dissection (ESD) according to the first aspect of the present invention has a small diameter connected to an anchoring member that is anchored to a lesion site on the inner surface of a living tube. One or a plurality of magnetic anchors made of a magnetic member, and one or a plurality of sealed bodies that are attached to the distal end portion of an endoscope that is inserted in the vicinity of a lesion site in the living body tube and imparts an electromagnetic repulsive force to the magnetic anchor Magnetic flux radiating means including the generated magnetism element, and magnetic flux control means provided outside the living body and controlling the distribution of magnetic flux radiated from the magnetic flux radiating means from the outside, the magnetic flux control means, The magnetic flux distribution from the magnetic flux radiating means is controlled from the outside so that an electromagnetic repulsive force is applied to the magnetic anchor, and the lesion site engaged with the engaging member is pulled away from the muscle layer of the biological duct. It is characterized by That.

A second aspect of the invention is the ESD surgical system according to the first aspect, wherein one or a plurality of angle sensors or / and position sensors provided in the endoscope or / and the magnetic flux radiating means are provided. The magnetic flux radiation means positioning control unit for controlling the bending drive portion provided in the endoscope so as to stop and hold at any desired bending angle position of the magnetic flux radiation means mounted on the endoscope tip. Is further provided.

A third aspect of the present invention is the ESD surgical system according to the first or second aspect, wherein the magnetic flux radiating means is made of a thin film of an elastomer or a resin material and is attached to and detached from the outer diameter of the distal end portion of the endoscope. An inner cylinder that is externally fitted and a plurality of elongated rods or strips that are substantially equally arranged in the circumferential direction on the outer circumference of the inner cylinder and are provided along the axial direction. In the magnetic flux radiation cylinder, the magnetism generating element is sealed with a thin film of elastomer or resin material.

A fourth aspect of the present invention is the ESD surgical system according to the first or second aspect, wherein the magnetic flux radiating means is formed of a flexible elongated rod-like or strip-like magnetic generating element made of an elastomer or a resin. The one or more magnetic anchors are hermetically packaged with a thin film of a system material, and are formed in a single loop shape that can be pulled out from the distal end in a loop state in the treatment instrument guide channel of the endoscope. Is characterized in that it can be arranged in a loop shape so as to surround the lesion site to which it is attached.

A fifth aspect of the present invention is the ESD surgical system according to any one of the first to fourth aspects, wherein the magnetism generating element is wound around an elongated rod-like or linear magnetic core member. It is characterized by comprising a conductive coil.

The invention according to claim 6 is the surgical operation system for ESD according to any one of claims 1 to 4, wherein the magnetism generating element is a wavy line in which an ultrathin conducting wire is a short period on an elongated strip-like semiconductor substrate. Alternatively, it is characterized by being printed and wired in a sine curve.

The invention according to claim 7 is the ESD surgical operation system according to any one of claims 1 to 4, wherein the magnetism generating element is an elongated rod-like or linear or strip-like magnetic core member. , And a magnetic field shield cylinder comprising a hollow magnetic field shield member externally fitted to the magnetic core member so as to be slidable in the longitudinal direction.

The invention according to claim 8 is the ESD surgical system according to claim 1, wherein the outer shape of the magnetic member of the magnetic anchor gradually expands from the proximal end portion connected to the engaging member toward the distal end portion. It is characterized by being formed.

A ninth aspect of the present invention is the ESD surgical system according to the first aspect, wherein the magnetic member of the magnetic anchor has a small-diameter hollow cylindrical shape or a tapered conical cylindrical shape connected to the engaging member. It is characterized by comprising a magnetic body outer cylinder and a solid or encapsulated magnetic fluid-like magnetic body rotating member housed rotatably around the central axis in the magnetic body outer cylinder.

The invention of claim 10 is the ESD surgical system according to claim 1 or 8, wherein the magnetic member of the magnetic anchor is made of at least two different materials in the longitudinal direction. .

The invention according to claim 11 is the ESD surgical operation system according to claim 1, wherein the magnetic flux control means includes a foot operation section that can be operated by an ESD surgeon with his / her foot during the operation. It is said.

The invention according to claim 12 is the ESD surgical system according to claim 11, wherein the foot operating portion is provided between a bottomed box body whose upper portion is open and a substantially central portion of the box body. The box covered on the upper portion of the box body can be tilted in any direction through the universal support means and can be returned to the original posture by the elastic force of a plurality of compression spring members provided in the periphery thereof. A plurality of cover-like foot pedals, which are arranged substantially symmetrically corresponding to the respective magnetism generating elements of the magnetic flux radiating means around the inner bottom surface of the box body, and the electric resistance changes in conjunction with the tilting operation of the foot pedal. Variable electric resistance means.

A thirteenth aspect of the invention is the ESD surgical system according to the eleventh aspect, wherein the foot operating portion is forwardly between a bottomed box body having an open top and a rear end portion of the box body. A box cover-like foot pedal which is pivotally supported and can be returned to its original posture by the resilient force of a compression spring member provided between the front end portions, and is covered on the upper portion of the box body; and the box body And a variable electrical resistance means that changes electrical resistance in conjunction with the tilting operation of the foot pedal.

The invention of claim 14 is the ESD surgical system according to claim 12 or claim 13, wherein the magnetic flux control means is a voltage signal from each variable electrical resistance means of the foot operation unit connected to a power source. And a magnetic flux control unit for controlling a magnetic flux distribution of the magnetic flux radiating means by controlling a current value to each magnetism generating element of the magnetic flux radiating means.

A fifteenth aspect of the present invention is the ESD surgical system according to any one of the twelfth to fourteenth aspects, wherein each of the variable electric resistance means has an appropriate length to be attached to the inside of the bottom surface of the box body. An electric resistor, a sliding brush that slides in the longitudinal direction on the electric resistor, a sliding link whose base end is pivotally supported by the sliding brush, and a base end that is the box body A support link pivotally supported by an end bracket provided on the inner side of the bottom surface of the sliding link, and a distal end portion pivotally supported by the distal end portion of the sliding link, and a base end portion of the sliding link, A return spring member suspended between the base end portion of the support link or the bottom surface of the box body and bending and holding both links in a square shape, and both the links linked to the tilting operation of the foot pedal. Is the top of the foot pedal. By swinging by being pressed by the inner surface, the sliding brush is characterized by electrical resistance and sliding on electrical resistor in the longitudinal direction is variable.

A sixteenth aspect of the invention is the ESD surgical system according to the twelfth aspect, wherein the universal support means is fixed to a substantially central portion of a ceiling inner surface of the foot pedal or a bottom surface of the box body. A frame, a second frame pivotally supported by the first frame so as to be swingable about the X axis in the front-rear direction of the foot pedal, and a foot pedal orthogonal to the X axis on the second frame A third frame that is pivotably supported about the Y axis in the left-right direction, and the attachment portion of the third frame is substantially the bottom surface of the box body or the ceiling inner surface of the foot pedal. It consists of a gimbal mechanism fixed to the center.

The invention according to claim 17 is the ESD surgical operation system according to any one of claims 11 to 16, wherein the foot operation portion has an inclined surface having an upward slope toward the front. It is characterized by having.

The invention according to claim 18 is the ESD surgical system according to claim 7, wherein the magnetic flux control means is inserted into the endoscope and connected to the rear end of the magnetic field shield tube. The magnetic flux distribution of the magnetism generating element is controlled by sliding the magnetic field shield cylinder back and forth with respect to the magnetic core member via the member.

According to the ESD surgical method of the nineteenth aspect of the present invention, one or a plurality of magnetic anchors in which a small-diameter magnetic member is connected to an anchoring member for anchoring a biological tissue is attached to a lesion site on the inner surface of the biological tube. A magnetic flux radiating means including one or a plurality of sealed magnetism generating elements that are engaged with each other and apply an electromagnetic repulsive force to the magnetic anchor is attached to the distal end portion of the endoscope, and the distal end of the endoscope The magnetic flux radiating means is appropriately disposed toward the magnetic anchor by inserting a portion near the lesion site in the biological tube, and the magnetic flux control means for controlling the distribution of the magnetic flux radiated from the magnetic flux radiating means from the outside of the living body. The endoscope controls the magnetic flux distribution from the magnetic flux radiating means, applies an electromagnetic repulsive force to the magnetic anchor, and pulls the lesion site to which the magnetic anchor is anchored in the direction of separating from the muscle layer of the biological tube. Guiding the treatment tool at the tip It is characterized by performing a submucosal dissection of the lesion site using the cutting instrument from Yan'neru.

The invention according to claim 20 is the ESD surgical method according to claim 19, wherein one or more angle sensors or / and position sensors provided in the endoscope or / and the magnetic flux radiation means are used. It further comprises a magnetic flux radiation means positioning control unit for controlling the bending drive section provided in the endoscope so as to stop and hold at any desired bending angle position of the magnetic flux radiation means attached to the endoscope distal end portion. It is characterized by that.

The invention according to claim 21 is the surgical method for ESD according to claim 19 or claim 20, wherein the magnetic flux radiating means is made of a thin film of a laster or a resin material, and is attached to and detached from the outer diameter of the endoscope distal end portion. A magnetic flux radiation cylinder comprising an inner cylinder that is externally fitted, and a plurality of elongated bar-shaped or strip-shaped magnetic generating elements that are substantially equally arranged in the circumferential direction on the outer circumference of the inner cylinder and are provided along the axial direction. The magnetism generating element is sealed with a thin film of an elastomer or a resin material.

The invention according to claim 22 is the ESD surgical method according to claim 19 or 20, wherein the magnetic flux radiating means is formed of a flexible elongated rod-like or strip-like magnetic generating element made of an elastomer or a resin. A thin film of a system material is hermetically packaged, and is formed into a single loop shape that can be pulled out from the distal end in a loop state in the treatment instrument guide channel of the endoscope, and the one or more magnetic anchors are It is characterized in that it can be arranged in a loop shape so as to surround the lesioned site.

The invention according to claim 23 is the ESD surgical method according to any one of claims 19 to 22, wherein the magnetism generating element is wound around an elongated rod-like or linear magnetic core member. It is characterized by comprising a conductive coil.

A twenty-fourth aspect of the invention is the ESD surgical method according to any one of the nineteenth to twenty-second aspects, wherein an ultrathin wire is formed into a short-period wavy line or a sine curve shape on a strip-like semiconductor substrate. It is characterized by printed wiring.

The invention according to claim 25 is the ESD surgical method according to any one of claims 19 to 22, wherein the magnetism generating element is an elongated rod-like, linear or strip-like magnetic core member. And a magnetic field shield cylinder made of a hollow magnetic field shield member externally fitted to the magnetic core member so as to be slidable in the longitudinal direction.

The invention of claim 26 is the ESD surgical method according to claim 19, wherein the magnetic member of the magnetic anchor gradually expands its outer shape from the proximal end portion to the distal end portion connected to the engaging member. It is characterized by having formed.

The invention according to claim 27 is the ESD surgical method according to claim 19, wherein the magnetic flux control means includes a foot operation unit that can be operated by an ESD surgeon with his / her foot during the operation. It is a feature.

The invention according to claim 28 is the ESD surgical method according to claim 27, wherein the foot operation part is provided between a bottomed box body having an open top and a substantially central part of the box body. A box-covered foot covering the upper part of the box body so that it can be tilted in any direction through the universal support means and can be returned to its original posture by the elastic force of a plurality of compression spring members provided in its periphery. A plurality of variable electrical resistors that are arranged substantially symmetrically corresponding to each magnetic generating element of the magnetic flux radiating means on the inner periphery of the bottom surface of the box body and change the electrical resistance in conjunction with the tilting operation of the foot pedal. Means.

The invention according to claim 29 is the ESD surgical method according to claim 27, wherein the foot operating portion tilts forward between a bottomed box body having an open top and a rear end portion of the box body. A box cover-like foot pedal that covers the top of the box body so as to be pivotally supported and capable of returning to the original posture by the elastic force of the compression spring member provided between the front end portions, and in the bottom surface of the box body And variable electric resistance means for changing the electric resistance in conjunction with the tilting operation of the foot pedal.

The invention of claim 30 is the ESD surgical method according to claim 28 or claim 29, wherein the magnetic flux control means outputs a voltage signal from each variable electric resistance means of the foot operation unit connected to a power source. And a magnetic flux control unit for controlling the distribution of the magnetic flux of the magnetic flux radiating means by controlling the current value to each magnetism generating element of the magnetic flux radiating means.

The invention according to claim 31 is the surgical method for ESD according to any one of claims 27 to 30, wherein the foot operation portion has an inclined surface having an upward slope toward the front. It is characterized by that.

The invention according to claim 32 is the ESD surgical method according to claim 23, wherein the magnetic flux control means is inserted into the endoscope and connected to the rear end portion of the magnetic field shield tube. The magnetic flux distribution of the magnetism generating element is controlled by sliding the magnetic field shield cylinder back and forth in the longitudinal direction with respect to the magnetic core member.

According to the inventions of Claims 1 and 19, the ESD surgeon can instantaneously reach the distal end of the endoscope by the magnetic flux control means in response to the situation in order to ensure a sufficient field of view by the endoscope during the operation. Since the magnetic flux distribution of the installed magnetic flux radiating means is appropriately controlled to give an electromagnetic repulsive force to the magnetic anchor, the lesion site attached to the magnetic anchor can be pulled away from the muscle layer of the biological tube, Since an accurate field of view with an endoscope is sufficiently secured, it is possible to quickly and easily perform an ESD surgical operation using an incision tool such as an electric scalpel, thereby ensuring operability, safety and reliability of the operation. In addition, there is an effect of reducing the operation time and operation invasion.

According to the inventions of claims 2 and 20, in addition to having the same effects as those of the inventions of claims 1 and 19, the magnetic flux radiating means positioning control unit for controlling the bending drive portion of the endoscope is used. From the angle sensor or / and the position sensor provided in the endoscope or / and the magnetic flux radiation means, the magnetic flux radiation means mounted on the distal end portion of the endoscope is stopped and held at any desired curved angular position. An accurate field of view with an endoscope is sufficiently ensured, and an ESD surgical operation with an incision tool such as an electric knife is facilitated, and the operability, safety and reliability of the operation are further improved.

According to the invention of claim 3 and claim 21, in addition to having the same effect as that of the invention of claim 1 or claim 2, and claim 9 or claim 20, the magnetic flux emitting tube is provided at the distal end of the endoscope. A plurality of elongated rod-like or strip-like magnetism generating elements are provided in a sealed state on the outer periphery of a substantially cylindrical inner cylinder that is detachably fitted to the outer diameter of the section, and the inner cylinder and the magnetism generating element sealing member are either In addition, since it is formed with a small diameter and soft touch made of a thin film of an elastomer or a resin-based material, it is possible to suppress an increase in pain during insertion into a living body of a patient. In addition, since the magnetic flux radiation tube having such a configuration can be configured at a relatively low cost, it can be appropriately and selectively applied to a single-use type or a multiple-use type in ESD surgery.

According to the invention of claim 4 and claim 22, in addition to having the same effect as the invention of claim 1 or claim 2 and claim 19 or claim 20, the magnetic flux radiating means has a flexible elongated rod shape. Alternatively, a belt-like magnetism generating element is sealed with a thin film of an elastomer or a resin material to form a single loop, and is placed in the endoscope treatment instrument guide channel so that it can be pulled out from the distal end in a looped state. Therefore, it is possible to eliminate the further increase in pain almost the same as the normal endoscope insertion into the living body of the patient. In addition, the loop-like magnetism generating element having such a configuration can be used a plurality of times in ESD surgery, or can be configured at a relatively low cost, so that it can be disposable once depending on the situation.

Further, by arranging the lesion site in a loop shape by one loop-like magnetism generating element of the magnetic flux radiation means, an electromagnetic repulsive force is simultaneously applied to a plurality of magnetic anchors attached to the lesion site, thereby improving efficiency. Since the lesion site can be often pulled away from the muscle layer of the biological duct to a desired position, the configuration of the magnetic flux control means for controlling the distribution of the magnetic flux radiated from one loop-like magnetism generating element from the outside. There are effects such as simplification and cost reduction.

According to the invention of claim 5 and claim 23, in addition to having the same effect as the invention of any one of claims 1 to 4, and 19 to 22, the magnetic generating element Since it is composed of a conductive coil wound around an elongated rod-shaped or linear magnetic core member, it is easy to manufacture at low cost using a general-purpose member, and has the effect of having a degree of freedom in design.

According to the invention of claim 6 and claim 24, in addition to having the same effect as the invention of any one of claims 1 to 4, and 19 to 22, the magnetic generating element The magnetic flux radiation means can be configured compactly and inserted into the patient's living officer because the ultra-thin conductors are printed and wired in the form of short-period wavy lines or sine curves on a strip-like semiconductor substrate. This has the effect of further suppressing the increase in pain.

According to the invention of Claim 7 and Claim 25, in addition to having the same effect as the invention of any one of Claims 1 to 4, and 19 to 22, the magnetic generating element Is composed of a magnetic shield tube that is slidably fitted to an elongated rod-like or linear or strip-like magnetic core member, so that the electric flux of the magnetic flux radiating means is unnecessary, greatly simplifying the magnetic flux control means, This has the effect of reducing costs.

According to the eighth and twenty-sixth aspects of the invention, in addition to having the same effects as the first and nineteenth aspects of the invention, the magnetic member of the magnetic anchor has a proximal end portion connected to the engaging member. The outer surface of the magnetic flux radiating means is opposed to the entire surface of the gradually expanding outer surface from the base end of the magnetic member toward the distal end of the magnetic anchor. Since the same S or N pole is formed, the repulsive force due to the magnetic flux from the opposing surface of the magnetic flux radiating means reaches the gradually expanding outer peripheral surface of the tip of the magnetic member of the magnetic anchor. It is possible to prevent the tip of the magnetic member of the formed magnetic anchor from being reversed in the direction of the facing surface of the magnetic flux radiating means, and there is an effect of improving the reliability and safety of ESD surgery.

According to the invention of claim 9, in addition to having the same effect as that of the invention of claim 1, the magnetic members of the magnetic anchor are both small-diameter hollow cylindrical or tapered cone cylinders made of magnetic material. In this magnetic outer cylinder, once a rotating force is applied to the magnetic rotating member with a finger or the like, a gyro moment acts by rotating the rotating member around the central axis. It is possible to prevent the tip portion where a different polarity from the end portion is formed from being reversed in the direction of the facing surface of the magnetic flux radiating means, and there is an effect of improving the reliability and safety of ESD surgery.

In addition to this, in the form of the tapered cone-cylinder magnetic body outer cylinder, the opposing surface of the magnetic flux radiating means is formed on the entire outer peripheral surface of the tapered cone-cylinder magnetic body cylinder gradually expanding from the base end portion toward the distal end portion. Since the same S or N pole is formed, the electromagnetic repulsive force due to the magnetic flux from the opposing surface of the magnetic flux radiating means extends to the gradually expanding outer peripheral surface of the tip of the tapered cone cylindrical magnetic outer cylinder. The effect of preventing the tip portion of the tapered cone-shaped magnetic outer cylinder in which the opposite pole (N or S pole) is formed in the opposite surface direction of the magnetic flux radiating means from being reversed is also superimposed.

According to the invention of claim 10, in addition to having the same effect as that of the invention of claim 1 or claim 8, the magnetic member of the magnetic anchor is composed of at least two different materials in the longitudinal direction, and the magnetic flux emission Since the same S or N pole as the facing surface of the means can be formed on the tip surface of the magnetic member of the magnetic anchor, the repulsive force due to the magnetic flux from the facing surface of the magnetic flux radiating means reaches the tip surface of the magnetic member of the magnetic anchor. Therefore, it is possible to prevent the tip of the magnetic member of the magnetic anchor from being reversed in the direction of the opposing surface of the magnetic flux radiating means, and there is an effect of ensuring the reliability and safety of the ESD surgery.

According to the invention of claim 11 and claim 27, in addition to having the same effect as that of the invention of claim 1 and claim 19, the ESD surgeon sufficiently secures the field of view by the endoscope during the operation. Therefore, in response to the situation, the foot operation unit is instantaneously operated with the foot to appropriately control the magnetic flux distribution of the magnetic flux radiating means, and an electromagnetic repulsive force is applied to the magnetic anchor, and the lesion site attached to the magnetic anchor is removed from the body Because it can be pulled away from the muscle layer, the field of view by the endoscope is sufficiently secured, so it is easy to concentrate the hand and quickly perform ESD surgical operation with an electric knife quickly and efficiently. It becomes possible. As a result, the operability, safety and reliability of the operation are improved, and the operation time is shortened.

According to the invention of claim 12 and claim 28, in addition to having the same effect as that of the invention of claim 11 and claim 27, the ESD surgeon sufficiently secures the field of view by the endoscope during the operation. Therefore, in response to the situation, the foot pedal of the foot operation unit is instantaneously depressed with the foot in the desired direction of the front, rear, left and right, and tilted to change the electrical resistance from the magnetic flux radiation means through a plurality of variable electrical resistance means. By finely controlling the magnetic flux distribution, it becomes easier to pull the lesion site attached to the magnetic anchor in any direction from the muscle layer of the biological tube by applying an electromagnetic repulsive force to the magnetic anchor in any direction. Therefore, since an accurate field of view by the endoscope is sufficiently ensured, there is an effect of further improving the operability, safety and reliability of the operation for efficiently performing the ESD surgery alone.

According to the invention of claim 13 and claim 29, in addition to having the same effect as that of the invention of claim 11 and claim 27, one variable electrical resistance is interlocked with the tilting motion of the foot pedal in the front-rear direction. 23. Suitable for controlling the magnetic flux intensity of the magnetic flux emitting means according to claim 4 and claim 22 having one loop-like magnetism generating element since the electrical resistance of the means is changed, and ESD surgery. Magnetic flux intensity from one loop-like magnetism generating element as a magnetic flux radiating means by instantly operating the foot operation part with the foot in response to the situation in order to ensure a sufficient field of view by the endoscope during surgery Since it becomes easier to pull the lesion site attached to one or more magnetic anchors simultaneously in the direction of pulling away from the muscle layer of the biological tube, by appropriately controlling With a better endoscope Field is ensured, the operation of efficiently performing surgery ESD surgery alone, there are safety and effect of the reliability is further improved. In addition, since the foot operation unit simply tilts the foot pedal in one longitudinal direction and at least one variable electric resistance means is sufficient, the configuration of the surgical system for ESD is simplified, and the economy and operation are improved. There is also an effect of improving the property.

According to the invention of claim 14 and claim 30, in addition to having the same effect as that of the invention of claim 12 or claim 13, or claim 28 or claim 29, it is provided in the magnetic flux control means. The magnetic flux control unit receives a voltage signal from each variable electrical resistance means of the foot operation unit connected to the power source, controls the current value to each magnetic generating element of the magnetic flux radiating means, and controls the magnetic flux intensity of each magnetic generating element. By controlling, there is an effect that the magnetic flux distribution from the magnetic flux radiating means is accurately controlled.

According to the invention of claim 15, in addition to having the same effects as those of the invention of any one of claims 12 to 14, the variable electric resistance means provided in the foot operation portion is provided by tilting the foot pedal. The sliding link and the tip of the support link are pressed against the ceiling surface of the foot pedal in conjunction with the operation, and the sliding brush slides on the electrical resistor by swinging both links, so that the electrical resistance can be varied. Therefore, there is an effect that the mechanism is simple and reliability is ensured by a stable operation with variable electric resistance.

According to the invention of claim 16, in addition to having the same effect as that of the invention of claim 12, the universal support means of the foot pedal is fixed to the ceiling inner surface of the foot pedal or the bottom surface of the box body. A second frame that is swingable about the X axis in the front-rear direction is pivotally supported on the frame body, and a third frame is pivotally supported on the second frame so as to be swingable about the Y axis in the left-right direction. Since the body is composed of a gimbal mechanism that is fixed to the bottom surface of the box body or the ceiling inner surface of the foot pedal, there is an effect that a stable and stable tilting operation in a compact and highly reliable direction of the foot pedal can be ensured.

According to the invention of claim 17 and claim 31, in addition to having the same effect as the invention of any one of claims 11 to 16, and 27 to 30, the foot operation part Since the upper surface is an inclined surface having an upward slope toward the front, it is easy to perform a delicate depressing operation with the foot of the foot pedal, and there is an effect that favorable tilting operability is ensured.

According to the eighteenth and thirty-second aspects of the invention, in addition to having the same effects as the seventh and twenty-fifth aspects of the invention, it is inserted into the endoscope and connected to the rear end portion of the magnetic shield cylinder. By controlling the magnetic flux intensity of the magnetism generating element by sliding the magnetic field shield cylinder back and forth in the longitudinal direction with respect to the magnetic core member via the linear member formed, the magnetic flux control means is greatly simplified and the cost is reduced. There is an effect that can be downed.

1 is a conceptual diagram of an ESD surgical system according to an embodiment of the present invention. It is a perspective view which shows the concept of the endoscope with which the magnetic flux radiation | emission means (flux radiation pipe | tube) in the surgical system for ESD of FIG. 1 was mounted | worn by the front-end | tip part. It is an enlarged view of the endoscope front-end | tip part with which the magnetic flux radiation tube of FIG. 2 was mounted | worn. (A) is a front view of an endoscope distal end portion to which a magnetic flux radiation tube of a modified embodiment is mounted, and (b) is a front view of an endoscope distal end portion to which a magnetic flux radiation tube of another modified embodiment is mounted. (C) is a front view of the endoscope front-end | tip part with which the magnetic flux radiation tube of another modified embodiment was mounted | worn. It is a partial longitudinal cross-sectional conceptual diagram which shows the concept of the submucosal layer exfoliation of the lesion site | part in the biological vessel by the surgical system for ESD of FIG. (A) is a conceptual diagram of the magnetic anchor by another embodiment of this invention, (b) is a conceptual diagram of the magnetic anchor by another embodiment. It is a perspective view which shows the concept of the foot operation part by one Embodiment of this invention. (A) is a longitudinal sectional view in the X-axis direction of FIG. 7, (b) is a longitudinal sectional view in the Y-axis direction, and (c) is an enlarged longitudinal sectional view of a universal support means mounting portion of a foot operation portion according to another embodiment. It is. It is a partial longitudinal cross-sectional conceptual diagram which shows the concept of the submucosal layer exfoliation of the lesion site | part in the biological vessel by the surgical system for ESD of another embodiment of this invention. It is a longitudinal cross-sectional view of the X-axis direction which shows the concept of the foot operation part corresponding to embodiment of FIG. It is a perspective view which shows the concept of the magnetism generation element of another modified embodiment of this invention. It is a top view which shows the concept of the magnetic generation element of another modified embodiment of this invention. It is an enlarged view of the endoscope front-end | tip part with which the magnetic flux radiation means (flux radiation cylinder) which shows the attachment concept of the angle sensor for magnetic flux radiation means positioning of another deformation | transformation embodiment of this invention was mounted | worn. FIG. 11 is a perspective view of an endoscope in which a magnetic flux radiation means (flux radiation cylinder) showing a mounting concept of a magnetic flux radiation means positioning angle sensor (rotation angle sensor) according to still another modified embodiment of the present invention is attached to a distal end portion. . (A) is a conceptual diagram of the magnetic anchor by another embodiment of this invention, (b) is a conceptual diagram of the magnetic anchor by another embodiment. (A) is a conceptual diagram of the magnetic anchor by another embodiment of this invention, (b) is a conceptual diagram of the magnetic anchor by another embodiment. It is a conceptual diagram of the treatment tool for ESD of the former (patent document 1). It is a conceptual diagram of the treatment tool for ESD of the past (patent document 2). It is a conceptual diagram of the treatment tool for ESD of the past (patent document 3). It is a conceptual diagram of the treatment tool for ESD of the past (patent document 4). It is a conceptual diagram of the treatment tool for ESD of the past (patent document 5).

Hereinafter, specific examples of the best mode for carrying out the endoscopic submucosal dissection (ESD) surgical system and surgical method of the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is a conceptual diagram showing a main configuration concept of an ESD surgical system according to an embodiment of the present invention, and FIG. 2 is a perspective view of the ESD surgical system of FIG. 3 is a perspective view showing the concept of the endoscope, FIG. 3 is an enlarged view of the distal end portion of the endoscope to which the magnetic flux emitting tube of FIG. 2 is attached, and FIGS. 4A, 4B, and 4C are different from each other. FIG. 5 is a partially longitudinal view showing the concept of submucosal dissection of a lesion site in a living body by the ESD surgical system of FIG. 1. FIG. It is a surface conceptual diagram. Each of the drawings attached here is a conceptual diagram showing the main structural concept expressed in the knot scale, and in particular, FIG. 5 is expressed by enlarging the radial direction compared to the axial direction in order to make the internal structure easy to understand. ing.

As shown in FIGS. 1 to 5, an ESD surgical system according to an embodiment of the present invention has a small diameter connected to a locking member 21 that is locked to a lesion T2a on the inner surface of a living tube T such as a digester. A magnetic anchor 20 composed of a magnetic member (also referred to as “magnetic member”) 22 and a thin, substantially cylindrical shape that is circumferentially attached to the outer periphery of the inner cylinder 12 that is attached to the distal end portion 41 of the endoscope 40. The magnetic coil 15 as a plurality of magnetism generating elements that are substantially equally arranged along the axial direction is provided in a hermetically sealed state, and the magnetic flux radiation cylinder 10 that is a magnetic flux radiation means that imparts an electromagnetic repulsive force to the magnetic anchor 20, and the outside of the living body And a magnetic flux control means 70 for controlling the distribution of the magnetic flux M emitted from the front end surface of each magnetic coil 15 in the magnetic flux radiating cylinder 10 from the outside.

As shown in FIG. 3, the magnetic flux radiating cylinder 10 of this embodiment is made of a thin film of an elastomer or a resin material, and an inner cylinder 12 that is detachably fitted to the outer diameter of the endoscope tip 41 and an outer A hollow double cylinder in which the space between the cylinder 11 and the front and

rear end walls

13 and 14 is hermetically sealed, and the inside of the double cylinder hollow, that is, between the inner cylinder 12 and the outer cylinder 11, is approximately in the circumferential direction. A plurality of small-diameter magnetic coils 15 (at least three in the figure, four in the upper, lower, left, and right directions) composed of the conductive coils 15a wound around the thin rod-shaped magnetic core member 15b, which are equally arranged and arranged along the axial direction. It consists of.

The magnetic coil 15 of this embodiment is formed to have a small diameter of about several millimeters from a conductive coil 15a obtained by winding a thin wire or a rod-like magnetic core member 15b with a thin conductive wire such as hair. A total of eight lead wires 15c of each magnetic coil 15 are collected and accommodated in a heat shrinkable tube having a diameter of about 1 mm, and contracted by heating to form an electromagnetic coil lead wire cord Lc having a diameter of about 0.6 mm. Is done. As shown in FIGS. 1 and 2, the electromagnetic coil lead wire cord Lc is taken out from the rear end portion of the magnetic flux radiating tube 10, is provided along the insertion portion 42 of the endoscope 40, and is taken out from the operation portion 43 to the outside. .

As shown in FIG. 4A, the hollow double-cylinder magnetic flux radiation cylinder 10 made of a thin film of elastomer or resin material is actually provided with a flexible outer cylinder 11 outside the magnetic coil 15 and the endoscope distal end 41. It is configured in a deformed shape so as to be in close contact with the outer shape of the inner cylinder 12 to be fitted. In particular, when at least the outer cylinder 11 is made of a heat-shrinkable resin material, the outer cylinder 11 can be formed into a shape that is contracted and deformed in a fully adhered state along the outer shapes of the magnetic coil 15 part and the inner cylinder 12. .

In addition, as shown in FIG. 4 (b), as a magnetic flux radiation tube 10 'of another modified embodiment, an endoscope tip is formed by a thin film 11' of an elastomer or a resin material instead of the outer tube 11 in the above embodiment. Adhering to the outer surface of the inner cylinder 12 in a state in which a plurality of magnetic coils 15 that are substantially equally distributed in the circumferential direction and provided side by side in the axial direction are individually covered on the outer surface of the inner cylinder 12 that is externally fitted to the portion 41. Thus, each magnetic coil 15 can be sealed.

Further, as shown in FIG. 4 (c), as a magnetic flux radiation tube 10 '' of another modified embodiment, an elastomer or a resin-based material thin film 11 '' is used instead of the outer tube 11 in the above embodiment. A plurality of single hermetically sealed magnetic coils 15 that are hermetically sealed are provided on the outer surface of the inner cylinder 12 that is externally fitted to the endoscope distal end portion 41, and is substantially equally distributed in the circumferential direction and adhered along the axial direction. It can also be configured.

Needless to say, any of the above-described heat-shrinkable tube materials, elastomers, or resin-based materials used for the magnetic flux radiation tube 10 are medically compatible materials.

Since the magnetic

flux radiation tubes

10, 10 ′, 10 ″ made of such an elastomer or a resin material are formed with a small diameter and a soft touch, pain in insertion into the living body T such as a patient's digestive tract is caused. The increase can be suppressed. In addition, since the magnetic flux radiation tube having such a configuration can be configured at a relatively low cost, it can be selectively applied to a single-use type or a multi-use type in ESD surgery.

As shown in FIG. 5, the magnetic anchor 20 includes an engaging member 21 attached to a lesioned part T <b> 2 a on the inner surface of the biological tube T, a small-diameter magnetic member 22, and a connecting member 23 that connects both the

members

21 and 22. It consists of. The engaging member 21 is a claw having a variable interval at the tip of various engaging tools conventionally used for grasping and lifting the lesioned part T2a in the biological tube T, for example, a main body part (not shown) bent in a U shape. A clip 21a or the like in which a ratchet portion (space adjustment portion) 21b is provided, which is provided with a shaped tip portion and is fixed to a position after adjusting the space between the paired body portions, can be applied. The ratchet portion 21b has a function of preventing the deformation when the paired main body portions are elastically deformed in the direction of reducing the interval and holding the adjusted narrow interval. The clip 21a in the initial state is in an open state due to its elasticity.

The connecting member 23 is connected, for example, by hooking hook portions (not shown) provided at both ends thereof to base end portions 22b of the magnetic member 22 and holes (not shown) provided in the clip 21a. The connecting member 23 can be a rigid body, an elastic material such as a spring or rubber, or a flexible material. Any of the connecting members 23 can be configured such that a length is adjustable by providing a feeding mechanism in a hook portion (not shown).

The magnetic anchor 20 may be configured to directly connect the clip 21a and the magnetic member 22 without using the connecting member 23, or the clip 21a and the magnetic member 22 may be formed as a single body.

As shown in FIG. 5, the magnetic member 22 of this embodiment is a tapered cone whose outer shape gradually increases from a base end portion 22 b connected to the engaging member 21 toward a tip end portion 22 a which is a free end. It is formed in a body shape.

As a result, the same S or N pole as the distal end surface of the magnetic flux radiating cylinder 10 facing the entire surface of the cone outer surface gradually expanding from the proximal end portion 22b toward the distal end portion 22a of the magnetic member 22 is formed. Since the repulsive force due to the magnetic flux from the front end surface of the magnetic flux radiating cylinder 10 reaches the outer peripheral surface of the tip portion 22a of the magnetic member 22 of the magnetic anchor 20 that gradually increases, a different polarity (N or S pole) is formed. It is possible to prevent the front end portion of the magnetic member 22 from being pulled in the direction of the front end surface of the magnetic flux radiating tube 10 and being inverted.

As shown in FIGS. 1 to 3 and FIG. 5,

angle sensors

17 and 18 are attached to, for example, two positions perpendicular to the axis of the outer peripheral surface of the tip of the magnetic flux emitting tube 10. Via the

control signals

17a, 18a, the distal end portion 41 of the endoscope 40 is stopped and held at any desired bending angle position of the magnetic flux emitting tube 10 attached to the distal end portion 41 of the endoscope 40. It further includes a magnetic flux radiation means positioning control unit 51 having an endoscope bending control unit 51a for controlling a bending driving unit (not shown) that changes the bending posture of the adjacent bending part 42b. The endoscope 40 used here controls the rotation of a motor built in as a bending drive unit of a bending drive unit (not shown), pulls and loosens the bending operation wire by the driving force of the motor, and electrically drives the bending unit. A known electric bending endoscope that performs a bending operation can be applied. The electric bending endoscope 40 is well known and will not be described in detail. However, the operation unit 43 includes a joystick for operating the bending unit 42b and power for driving the bending drive mechanism by the driving force of the motor. There are provided an operation part of a clutch mechanism for intermittently operating transmission, an operation part of an engagement mechanism for fixing the bending part 42b at an arbitrary bending position (bending angle) (see FIG. 14 and its description later). ). Therefore, the tilt operation amount from the neutral state by the joystick is input as the bending operation input amount (bending operation instruction amount) to the endoscope bending control unit 51a via the

control signals

17a and 18a from the

angle sensors

17 and 18. The bending control unit 51a electrically drives a bending drive unit provided in the operation unit 43, and pulls and relaxes the bending operation wire by a bending angle corresponding to the bending operation input amount, thereby electrically driving the bending unit 42b. Curve.

As the

angle sensors

17 and 18, for example, a known very small and light 1-axis to 3-axis angle sensor using a mechanical, fluid, optical gyroscope, vibration gyroscope, or the like can be selectively applied. Note that the three-dimensional angles of the roll, pitch, and yaw of the bending portion 42b can be detected by using the advantages of the gyro and the accelerometer.

This magnetic flux radiation means positioning control unit 51 is controlled so as to stop and hold the magnetic flux radiation cylinder 10 attached to the endoscope distal end portion 41 at any desired curved angle position in cooperation with the endoscope curvature control unit 51a. By doing so, it is easy to sufficiently secure the field of view by the endoscope 40, it is easy to perform an ESD surgical operation with an incision tool such as an electric knife, and the operability, safety and reliability of the operation can be further improved. .

6 (a) and 6 (b) are conceptual diagrams of magnetic anchors 20 'and 20 "according to different embodiments of the present invention.

As shown in FIG. 6A, the magnetic member 22 ′ of the magnetic anchor 20 ′ according to another embodiment includes a small-diameter hollow magnetic outer cylinder 22 ′ a connected to the engaging member 21 and a magnetic outer cylinder 22. It is composed of a magnetic rotating member 22'c that is rotatably arranged around a central axis 22'd in 'a.

The magnetic body rotating member 22'c has a plurality of substantially disk bodies, short rod bodies, small plate members, or one or a plurality of split-type spiral members inserted through the central shaft 22'd and fixed to the outside. It is formed in a cylindrical body slightly thinner than the inner diameter of the cylinder 22'a.

The magnetic member 22 ′ configured as described above is configured to rotate around the central axis once a rotational force is applied to the magnetic rotating member 22 ′ c with a finger or the like within a small-diameter hollow magnetic outer tube 22 ′ made of a magnetic material. Since the gyro moment is applied when the magnetic rotating member 22′c is constantly rotated, the tip 22′aa where the magnetic pole 22′aa is formed with a different polarity from the base end 22′b of the magnetic member 22 ′ is a magnetic flux. It is possible to prevent the radiation tube 10 from being pulled and reversed in the direction of the distal end surface.

Further, as shown in FIG. 6B, the magnetic member 22 ″ of the magnetic anchor 20 ″ according to another embodiment is made of a magnetic material and is connected to the engaging member 21. b is a small-diameter hollow tapered cone-shaped cylindrical outer cylinder 22 ″ a that gradually expands toward the tip 2 ″ aa, and rotates around the central axis 22 ″ d within the outer cylinder 22 ″ a. It is comprised from the magnetic body rotation member 22''c freely accommodated.

The magnetic rotating member 22 ″ c has a plurality of substantially disk bodies, short bar bodies, small plate members, or one or a plurality of divided spiral members inserted through the central shaft 22 ″ d and fixed. Is formed in the shape of a tapered cone slightly thinner than the inner diameter of the outer cylinder 22 ″ a.

The magnetic member 22 ″ configured as described above is centered once a rotational force is applied to the magnetic rotating member 22 ″ c with a finger or the like in a hollow magnetic outer tube 22 ″ a made of a magnetic material. Since the gyro moment is applied by constantly rotating the magnetic rotating member 22 ″ c around the axis, the distal end portion where a different polarity from the proximal end portion 22 ″ b of the magnetic member 22 ″ is formed. It can be prevented that 2 ″ aa is attracted in the direction of the front end surface of the magnetic flux radiating tube 10 and reversed. In addition to this, it faces the entire outer peripheral surface of the tapered conical cylindrical outer cylinder 22''a that gradually expands from the proximal end 22''b to the distal end 2''aa of the magnetic member 22 ''. Since the same S or N pole as the front end surface of the magnetic flux radiation tube 10 is formed, the electromagnetic repulsion force due to the magnetic flux from the front surface of the magnetic flux radiation tube 10 gradually expands the front end portion 2''aa of the magnetic member 22 ''. The tip end 2 ″ aa of the magnetic member 22 ″ having a different polarity (N or S pole) with respect to the outer peripheral surface is drawn toward the tip end surface of the magnetic flux radiating cylinder 10 and reversed. The effect of preventing this is also superimposed.

As shown in FIG. 1, the magnetic flux control means 70 according to an embodiment includes a plurality of variable electrical resistance means 36 therein, and an foot operation unit 30 that can be operated by an ESD surgeon with his / her foot during surgery. In response to the voltage signal from each variable electrical resistance means 36 of the foot operating unit 30 connected to the power source E, the current value to each magnetic coil 15 in the magnetic flux radiating cylinder 10 is controlled to distribute the magnetic flux of each magnetic coil 15. And a magnetic flux control unit 60 for controlling.

7 is a perspective view showing a concept of a foot operation unit according to an embodiment of the present invention, and FIGS. 8A and 8B are longitudinal sectional views in the X and Y axis directions of FIG. 7, respectively.
The foot operation unit 30 of this embodiment includes a bottomed box body 32 having an open top, a box cover-like foot pedal 33 covering the top of the box body 32, and the box body 32 and the foot pedal 33. A universal support means 34 that is provided in a substantially central portion and supports the foot pedal 33 so as to be tiltable in an arbitrary direction, and is provided in a peripheral portion between the box body 32 and the foot pedal 33. Corresponding to a plurality of compression spring members 35 (four in each of the four corners in the figure) that are elastically supported so as to be able to return to the posture, and each magnetic coil 15 in the magnetic flux emitting tube 10 around the bottom surface of the box body 32. And a plurality of variable electric resistance means 36 (in the figure, four at each of the four corners) whose electric resistance changes in conjunction with the tilting operation of the foot pedal 33.

At the lower part of the box body 32, one or a single base 31 having an inclined surface whose upper surface is an upward slope toward the front of the X axis is formed and attached. Thereby, it becomes easy to perform a delicate stepping operation by the foot of the foot pedal 33 whose upper surface is inclined in an uphill direction toward the front, and good tilting operability is ensured.

Each variable electric resistance means 36 is connected to the power source E via the power cord Le and the power switch SW, and is connected to the magnetic flux control unit 60 via the variable electric resistance means lead wire cord Lr. Further, FIG. 7 shows a conceptual diagram of the magnetic flux control unit 60 provided outside the foot operation unit 30, but actually, a control board plate (not shown) to which the lead wires of the variable electric resistance means 36 are connected. And the control board is preferably housed and incorporated in the bottom surface of the box body 32 in the foot operation unit 30, for example.

The universal support means 34 of this embodiment includes a first frame 34a fixed to a substantially central portion of the ceiling inner surface of the foot pedal 33, and the first frame 34a around the X axis in the front-rear direction of the foot pedal 33. A second frame 34b that is pivotably supported, and a third frame 34b that is pivotally supported about the Y axis in the left-right direction of the foot pedal 33 orthogonal to the X axis. A frame body 34c, and a mounting portion 34d of the third frame body 34c is constituted by a gimbal mechanism fixed to a substantially central portion in the bottom surface of the box body 32.

FIG. 8 (c) is an enlarged longitudinal sectional view of the universal support means mounting portion of the foot operating portion according to another embodiment.

As another embodiment, as shown in FIG. 8 (c), the universal support means 34 is set in the opposite direction to the above-described embodiment, that is, the first frame 34a is placed in the bottom surface of the box body 32, and the third The attachment part 34d of the frame 34c may be attached to the ceiling inner surface of the foot pedal 33.

Further, as another embodiment, from a spring member that can expand and contract between the mounting portion 34d of the first frame 34a or the third frame 34c and the ceiling inner surface of the foot pedal 33 or the bottom surface of the box body 32, etc. The foot pedal 33 can be configured to be able to be pushed down downward in an arbitrary posture state in a horizontal state or a tilted state. As an example, in FIG. 8C, the attachment portion 34d of the frame 34c includes a hollow attachment portion 34d1, a sliding attachment portion 34d2 that is in sliding contact with the hollow attachment portion 34d1, and a hollow attachment portion 34d1. A form is shown which comprises an elastic member 34d3 (elastic mechanism) such as a spring member disposed between the sliding attachment portion 34d2.

As described above, in the form in which the foot pedal 33 is supported by the universal support means incorporating the elastic mechanism, all the variable amounts can be obtained by pressing the foot pedal 33 downward in an arbitrary posture state in a horizontal state or a tilting state. Adjustment to relatively increase the magnetic flux M distribution from the tip of the magnetic flux radiation tube 10 by reducing the resistance of the electric resistance means 36 as a whole is possible. As a result, the fine adjustment range for separating the lesioned part T2a attached to the magnetic anchor 20 from the muscle layer T1 of the biological tube T is further expanded.

Further, as another modification, although not shown, the elastic member 34d3 in the form shown in FIG. 8C is omitted, and the elastic force of the compression spring member 35 shown in FIGS. 8A and 8B is used together. In other words, the compression spring member 35 may have a function of the elastic member 34d3. Therefore, in this modification, the foot pedal 33 maintains a gap (sliding stroke) between the hollow mounting portion 34d1 and the sliding mounting portion 34d2 of the universal support means 34 by the elastic force of the compression spring member 35. Supported by

As shown in FIGS. 8 (a) and 8 (b), the variable electric resistance means 36 according to one embodiment is mounted within the bottom surface of the box body 32 and has an appropriate length U channel type guide frame open. 36a, an electrical resistor Ra disposed along the longitudinal direction in the bottom surface of the guide frame 36a, a sliding brush Rb sliding in the longitudinal direction on the electrical resistor Ra, and a base end portion of the sliding brush Rb The sliding link 36b is pivotally supported by the first frame 36a and the end bracket 36d is pivotally supported by the end bracket 36d provided at one end of the guide frame 36a. The distal end of the sliding link 36b is pivotally supported. A support link 36c pivotally supported at the distal end portion, and a tension spring member suspended between the base end portions of the slide link 36b and the support link 36c to bend and hold both the

links

36b and 36c in a square shape. Litter A spring member 36e, composed.

Although the return spring member 36e is not shown in place of the tension spring member suspended between the base end portions of the sliding link 36b and the support link 36c in the form shown in FIGS. By suspending the compression spring member between the opposite end portion of the frame 36a on the end bracket 36d side and the base end portion of the sliding link 36b, both

links

36b and 36c are formed by the elastic force of the compression spring member. It is also possible to adopt a deformation form that is bent and held in a shape.

In conjunction with the tilting motion of the foot pedal 33, the sliding link 36b of the variable electrical resistance means 36 and the tip of the support link 36c are pressed by the link pressing portion 33a on the ceiling inner surface of the foot pedal 33 and swing, thereby sliding. The brush Rb slides in the longitudinal direction on the electric resistor Ra, and the electric resistance is varied.

In this case, the direction in which the link pressing portion 33a of the foot pedal 33 portion of the variable electric resistance means 36 disposed in the foot operation portion 30 is pushed down by the stepping operation of the foot and the tip portions of both

links

36b and 36c are pushed down. However, the resistance value of the electric resistor Ra decreases and the current value to the magnetic coil 15 in the magnetic flux radiating cylinder 10 increases, and the current value to the magnetic coil 15 increases from the magnetic coil 15. The radiated magnetic flux is increased, the electromagnetic repulsion force of the magnetic anchor 20 to the magnetic member 22 is increased, and the traction force that separates the lesioned part T2a attached to the magnetic anchor 20 from the muscle layer T1 of the biological tube T is increased.

On the contrary, when the foot stepping operation is loosened or the foot is released, the link pressing portion 33a of the foot pedal 33 rises and the leading end portions of both

links

36b and 36c are pulled back to the so-called initial state. However, the resistance of the electric resistor Ra increases and the current value to the magnetic coil 15 in the magnetic flux radiating cylinder 10 decreases, and the current value to the magnetic coil 15 decreases as the current value to the magnetic coil 15 decreases. The radiated magnetic flux M is reduced, the electromagnetic repulsive force of the magnetic anchor 20 to the magnetic member 22 is weakened, and the traction force that separates the lesioned part T2a attached to the magnetic anchor 20 from the muscle layer T1 of the biological tube T is weakened. .

With such a configuration of the foot operation unit 30, an ESD surgeon immediately depresses the foot pedal 33 with his / her foot in a desired direction in response to the situation in order to ensure a sufficient field of view by the endoscope 40 during the operation. By controlling the magnetic flux M distribution radiated from the front end surface of the magnetic flux radiation tube 10 through the plurality of variable electrical resistance means 36 whose electrical resistance changes by tilting, an electromagnetic repulsive force in a desired direction is given to the magnetic anchor 20. Thus, it becomes easy to separate the lesioned part T2a attached to the magnetic anchor 20 from the muscle layer T1 of the living body tube T in a desired direction, so that the field of view by the endoscope 40 is sufficiently secured. It is easy to concentrate and quickly perform an ESD surgical operation with an electric knife efficiently by one person. Thereby, the operability, safety and reliability of the operation can be improved and the operation time can be shortened.

Next, from the magnetic anchor 20 attached to the lesioned part T2a of the inner surface of the living body tube T of the present invention described above, the magnetic flux emitting tube 10 attached to the distal end portion 41 of the endoscope 40, and the distal end surface of the magnetic flux emitting tube 10 Using an ESD surgical system having a magnetic flux control means 70 for controlling the distribution of the radiated magnetic flux M from the outside, an ESD surgical operation for peeling the lower layer of the mucosa layer T2 of the lesion T2a on the inner surface of the digestive tract. The method will be described with reference to FIGS.

As shown in FIG. 5, the gastrointestinal tract T is composed of an outer muscle layer T1 and an inner mucosal layer T2. For example, the digestive tract T for ESD of the present invention in a state where a lesion T2a occurs in the mucosal layer T2 such as early gastrointestinal cancer. The surgical method has the following main steps.

First, the lesioned part T2a in the digestive tract T is identified by various diagnoses using an endoscope or the like (lesioned part identifying stage).

The lesioned part T2a in the gastrointestinal tract T is confirmed by inserting the endoscope 40 with the magnetic flux emitting tube 10 attached to the distal end 41 through a natural opening such as the mouth or anus (lesioned part confirmation stage). In each subsequent stage, the endoscope 40 continues to carefully observe / confirm the inside of the digestive tract T via various monitors and operation indicator LEDs (not shown in detail) (not shown). Surgery is performed carefully.

At this time, the magnetic flux attached to the endoscope distal end portion 41 by the magnetic flux radiation means positioning control unit 51 via the

control signals

17a and 18a from the

angle sensors

17 and 18 attached to the outer peripheral surface of the distal end portion of the magnetic flux emitting tube 10. The radiation tube 10 is held in a stopped state at any desired bending angle position.

Note that, on the front surface of the distal end portion 41 of the endoscope 40, for example, an air / water supply nozzle (not shown) for sending air and purified water at the time of excision of the lesioned portion T2a, an illumination window 46 for illuminating the lesioned portion T2a and its surroundings. In addition, an observation window 47 in which an objective lens is arranged to observe the lesioned part T2a and its periphery, and first and second treatment

instrument guide channels

44 and 45 are provided.

Next, physiological saline is injected with an injection needle (not shown) from the periphery of the lesion T2a to the lower layer of the mucosal layer T2, and the lesion T2a is lifted from the muscle layer T1 (injecting physiological saline). ).

Immediately after injecting the physiological saline, the engaging member 21, the connecting member 23, and the small-diameter magnetic member 22 of the magnetic anchor 10 are connected to the clip attachment tool (not shown) via the second treatment instrument guide channel 45 of the endoscope 40, for example. To the lesioned part T2a in the gastrointestinal tract T, and as shown in FIG. 5, the magnetic anchor 10 is anchored to the cut end T2b of the lesioned part T2a via the anchoring member 21 (magnetic anchor lesioned part engaging stage). .

Introduction and engagement of the engaging member 21 composed of the clip 21a and the ratchet portion 21b to the lesioned part T2a in the digestive tract T with a known flexible clip-shaped attachment fixture having a gripping portion at the tip is a conventional method. Since it can be performed by a method, detailed description is omitted.

Next, while observing / confirming the vicinity of the lesioned part T2a in the digestive tract T with the endoscope 40, the foot pedal 33 part of the foot operating part 30 is moved forward and backward in the X-axis direction or left and right in the Y-axis direction by stepping on the foot. Either part is pushed down (see FIGS. 5 and 7), and the electromagnetic repulsive force to the magnetic member 22 of the magnetic anchor 20 is adjusted so that the magnetic anchor 20 engaged with the cut end T2b of the lesioned part T2a is raised (see FIG. Magnetic anchor launch adjustment stage).

At this time, as shown in FIGS. 4, 5, 7, and the like, the upper and lower sides of the magnetic flux emitting cylinder 10 are arranged on the front and rear in the X-axis direction and on the left and right in the Y-axis direction in the bottom surface of the box body 32 of the foot operation unit 30. Since the four magnetic coils 15 arranged on the left and right are arranged substantially symmetrically and electrically coupled via lead wires, for example, when the rear part of the foot pedal 33 in the X-axis direction is pushed down, the magnetic flux emitting tube 10 The magnetic flux M from the tip of the magnetic coil 15 disposed in the lower part of the magnetic flux 15 is strong, and the magnetic flux M from the tip of the magnetic coil 15 disposed in the upper part of the magnetic flux radiation tube 10 is weakened. 10 The magnetic anchor 20 that has received a repulsive force to the magnetic member 22 due to the magnetic flux distribution from the tip end portion has a tendency to rise upward. Further, when the front portion of the foot pedal 33 in the X-axis direction is pushed down, the magnetic flux M from the tip of the magnetic coil 15 at the upper portion in the magnetic flux radiating cylinder 10 is strengthened, and the magnetic anchor 20 is pushed forward and tilted forward. When the left side in the Y-axis direction as viewed from the rear of the foot pedal 33 is pushed down, the magnetic flux M from the tip of the left magnetic coil 15 as seen from the back of the magnetic flux emitting tube 10 is strengthened, and the magnetic anchor 20 is moved to the tip of the endoscope. Tilt to the right as seen from 41. Further, when the right side in the Y-axis direction as viewed from the rear side of the foot pedal 33 is pushed down, the magnetic flux M from the tip of the right side magnetic coil 15 as viewed from the rear side in the magnetic flux radiating cylinder 10 is strengthened, and the magnetic anchor 20 is viewed from the inside. It tilts to the left when viewed from the mirror tip 41.

Subsequently, while observing / confirming the vicinity of the lesion T2a in the digestive tract T with the endoscope 40, an incision tool such as a high-frequency knife (not shown) is introduced into the digestive tract T from the first treatment instrument guide channel 44, for example. The lesioned part T2a of the mucosal layer T2 is separated from the cut end T2b with respect to the muscle layer T1 (lesioned submucosal layer peeling stage).

In this lesioned submucosal layer exfoliation stage, in order to ensure a sufficient field of view by the endoscope 40, the electrical resistance changes by instantly depressing and tilting the foot pedal 33 in the desired direction with the foot in response to the situation. The magnetic flux M distribution on the tip surface of the magnetic flux radiating cylinder 10 is controlled through the variable electric resistance means 36, and an electromagnetic repulsive force is applied to the magnetic anchor 20 in a desired direction so that the lesioned portion T2a attached to the magnetic anchor 20 is The adjustment is continued so as to be separated from the muscle layer T1 in a desired direction.

The lesioned part excised by appropriately adjusting the lesioned part T2a to be separated from the muscle layer T1 in a desired direction while gradually shifting the position and posture of the magnetic anchor 20 by the stepping operation of the foot of the foot operating part 30. Since T2a can be easily further separated from the muscle layer T1, visual confirmation of the distal end position of the incision tool is facilitated by the endoscope 40, and the excision work of the lesioned part T2a can be performed smoothly. As a result, it is possible to easily and quickly perform an ESD surgical operation by a cutting tool with one hand concentrated.

Subsequently, in a state where the lesioned part T2a with the magnetic anchor 20 still attached is gripped by gripping forceps (not shown) via the second treatment instrument guide channel 45 of the endoscope 40, for example, The switch SW is turned off, the supply of current to the magnetic flux radiating cylinder 10 is stopped (see FIG. 1), and the endoscope 40 is recovered by removing it from the digestive tract T as it is (lesioned part and endoscope extraction stage). At this time, the bending drive unit (not shown) is unlocked so that the bending posture of the bending portion 42b of the endoscope 40 can be freely changed.

Thereafter, treatment such as suturing and disinfection of the mucosal layer T2 from which the lesion T2a has been excised is performed (post-resection treatment stage).

FIG. 9 is a partial longitudinal sectional conceptual view showing the concept of submucosal dissection of a lesion site in a living body tube by an ESD surgical system according to another embodiment of the present invention, and FIG. 10 is a foot corresponding to the embodiment of FIG. It is a longitudinal cross-sectional view of the X-axis direction which shows the concept of an operation part.

The ESD surgical system according to another embodiment is mounted over the endoscope distal end portion 41 and applies magnetic repulsive force to the magnetic anchor 20 and magnetic flux M distribution from the magnetic flux radiating means 10a from the outside. Except for the point that the form of the foot operation part 30 'of the magnetic flux control means to be controlled is different, the rest is the same as in the above embodiment. Therefore, in FIGS. 9 and 10, the members having the same functions in FIGS. 1 to 8 of the embodiment are given the same reference numerals or symbols even if the shapes are partially different. Hereinafter, a different part from the said embodiment of the surgical system for ESD of another embodiment is demonstrated.

The magnetic flux radiating means 10a of this embodiment is formed in a flexible loop shape in which a small-diameter conductive coil 16a wound around a thin linear magnetic body (not shown) is hermetically packaged by an elastomer or resin-based material thin film 11a. For example, the endoscope 40 is constituted by a loop-shaped magnetic coil 16 which is a single loop-shaped magnetism generating element disposed in a treatment instrument guide channel 44 so as to be able to be pulled out from the distal end in a loop state.

The loop-shaped magnetic coil 16 of this embodiment has a conductive coil 16a in which a thin conductive wire, such as hair, is wound around a thin linear magnetic core member (not shown), which is made of an elastomer or a resin material, such as a heat-shrinkable tube. The thin film 11a is hermetically packaged to have a small diameter of about several mm. The two lead wires (not shown) of the loop-shaped magnetic coil 16 are collected and accommodated in, for example, a heat shrinkable tube having a diameter of about 0.5 mm and heated to be about 0.3 mm in diameter. Not) is formed. The electromagnetic coil lead wire cord is inserted into, for example, a treatment instrument guide channel 44 of an endoscope 40 as shown in FIGS. 1 and 2 and is taken out from the operation unit 43 (see FIG. 2).

Also in this embodiment, as shown in FIG. 9,

angle sensors

17 and 18 similar to those of the first embodiment are attached to, for example, two axially perpendicular directions on the outer peripheral surface of the distal end portion 41 of the endoscope 40. An arbitrary desired bending angle position of the magnetic flux radiating means 10a formed of the loop-shaped magnetic coil 16 deployed outside the distal end portion 41 of the endoscope 40 via the

control signals

17a and 18a from the

angle sensors

17 and 18. And a magnetic flux radiating means positioning control unit 51 for controlling a bending drive section (not shown) that changes the bending posture of the bending section 42b of the endoscope 40 so as to be stopped and held.

As shown in FIG. 9, the loop-shaped magnetic coil 16 drawn out in a loop state from, for example, the distal end of the treatment instrument guide channel 44 of the endoscope distal end portion 41 inserted to the vicinity of the lesioned portion T2a on the inner surface of the living tube T such as a digester. In addition, in order to facilitate the automatic arrangement in a loop shape so as to surround the lesioned part T2a to which a plurality of magnetic anchors 20 are attached, the magnetic core member has an elastic member or shape memory function having appropriate elasticity. It is desirable to apply a member. Depending on the state of the lesioned part T2a, the number of magnetic anchors 20 is appropriately selected as one or a plurality, and the size of the loop diameter of the loop-shaped magnetic coil 16 is appropriately set.

In this case, the anchoring of the magnetic anchor 10 to the lesion T2a cut end T2b, the loop arrangement / adjustment of the loop magnetic coil 16 around the lesion T2a, and the subsequent separation of the lesion T2a from the muscle layer T1. For example, the endoscope 40 is inserted into the vicinity of the lesioned part T2a in the digestive tract T through the second treatment instrument guide channel 45 of the endoscope 40 using a clip attachment tool or an incision tool (not shown). This is performed appropriately while observing / confirming with 40. It should be noted that the treatment order of the anchoring of the magnetic anchor 10 to the lesioned part T2a and the loop arrangement of the loop-shaped magnetic coil 16 around the lesioned part T2a depends on the state of the lesioned part T2a and the number of magnetic anchors 20 required. Depending on the situation, it can be carried out appropriately.

The foot operation unit 30 ′ of this embodiment includes a bottomed box body 32 ′ having an open top, a box cover-like foot pedal 33 ′ covering the top of the box body 32 ′, and a box body 32 ′. Provided between the rear end portions of the foot pedal 33 'and a pivot shaft mechanism 34' for pivotally supporting the foot pedal 33 'so as to be tiltable forward of the X axis, and the front end portions of the box body 32' and the foot pedal 33 '. A compression spring member 35 provided in the space and resiliently supports the foot pedal 33 ′ so as to be able to return to the original posture, and is disposed in the bottom surface of the front half of the box body 32 ′, and interlocks with the tilting operation of the foot pedal 33 ′. Variable electrical resistance means 36 that varies in electrical resistance.

The foot operation unit 30 ′ includes one variable electrical resistance means 36 corresponding to one loop-shaped magnetic coil 16 of the magnetic flux radiating means 10a, and the foot pedal 33 ′ is two-dimensional in the X-axis direction. Since the tilting operation is performed, it is sufficient that at least one compression spring member 35 for returning the original posture of the foot pedal 33 ′ is disposed between the front end portion of the foot pedal 33 ′ and the box body 32 ′. Therefore, the configuration of the foot operation unit 30 ′ of this embodiment is greatly simplified compared to the foot operation unit 30 shown in FIG. 7 of the above embodiment in which a plurality of variable electrical resistance means 38 and compression spring members 35 are disposed. The

Even in this case, the link pressing portion 33′a of the foot pedal 33 ′ portion of the variable electric resistance means 36 disposed in the foot operation portion 30 ′ is pushed down by the stepping operation of the foot, and the

links

36b and 36c are pressed. The direction in which the tip is pushed down is the direction in which the resistance of the electric resistor Ra decreases and the current value to the loop magnetic coil 16 of the magnetic flux radiating means 10a increases, and the current value to the loop magnetic coil 16 increases. As it increases, the magnetic flux M radiated from the loop magnetic coil 16 of the magnetic flux radiating means 10a increases, the electromagnetic repulsive force of the magnetic anchor 20 to the magnetic member 22 increases, and the lesioned part T2a attached to the magnetic anchor 20 The traction force in the direction of pulling away from the muscle layer T1 of the biological tube T becomes stronger.

On the other hand, by loosening the foot stepping operation or releasing the foot, the link pressing portion 33'a of the foot pedal 33 'rises and the tips of both

links

36b, 36c are pulled up, so-called initial state. The direction to return to is the direction in which the resistance of the electric resistor Ra increases and the current value to the loop-shaped magnetic coil 16 decreases, and as the current value to the loop-shaped magnetic coil 16 decreases, magnetic flux radiation occurs. The magnetic flux M radiated from the loop-shaped magnetic coil 16 of the means 10a decreases, the electromagnetic repulsive force of the magnetic anchor 20 to the magnetic member 22 is weakened, and the lesioned part T2a attached to the magnetic anchor 20 is replaced with the muscle layer of the biological tube T. The traction force in the direction away from T1 is weakened.

According to this embodiment configured as described above, an ESD surgeon immediately depresses the foot pedal 33 'with a desired strength with his / her foot immediately in response to a situation in order to ensure a sufficient field of view by an endoscope during the operation. The magnetic flux M radiated in a loop form from the loop-shaped magnetic coil 16 of the magnetic flux radiation means 10a is controlled through a single variable electrical resistance means 36 whose electrical resistance changes by tilting forward with Since the electromagnetic repulsive force is simultaneously applied to the magnetic anchor 20 and the lesioned part T2a engaged with the plurality of magnetic anchors 20 can be easily separated from the muscle layer T1 to a desired position, the field of view by the endoscope is improved. Sufficiently secured, it is easier to carry out ESD surgical operation with an electric knife quickly and efficiently with one hand concentrated. Thereby, the operability, safety and reliability of the operation can be improved and the operation time can be shortened.

As described above, according to the present invention, the endoscope 40 to which the magnetic flux radiating means 10 and 10a are attached over the distal end portion 41 is located near the lesioned part T2a in the digestive tract T from the natural opening such as the mouth or anus. The magnetic flux radiating means 10 and 10a are arranged opposite to the magnetic anchor 20 attached to the lesioned part T2a, and the position and posture of the magnetic anchor 20 by the stepping operation of the foot of the

foot operating parts

30 and 30 ′ are adjusted. By appropriately adjusting the lesioned part T2a to be separated from the muscle layer T1 of the biological tube T to a desired position while gradually shifting, the excised lesioned part T2a can be easily further separated from the muscle layer T1. Therefore, the endoscope 40 can easily confirm the tip position of the incision tool, and the lesion T2a can be smoothly separated. This makes it possible for one person to easily and quickly perform an ESD surgical operation with an incision tool by concentrating the hand and does not obstruct the field of view with an endoscope as in the prior art. May damage the normal part and cause complications such as perforation, damage the blood vessels and cause major bleeding, and even bleeding may cause serious complications due to the inability to stop the bleeding site Therefore, it is possible to provide an ESD surgical system and a surgical method using the same, which reduce the operation time and the surgical invasion and are excellent in the operability and reliability of the operation.

In addition to the above-described embodiment, the shape and configuration of each member and mechanism of the magnetic anchor, the magnetic flux radiating means, and the magnetic flux control means, or the angle sensor and / or position sensor for positioning the magnetic flux radiating means may be appropriately various. Modifications and changes can be made, and combinations thereof can be used as appropriate. Below, these various deformation | transformation embodiment is illustrated.

FIG. 11 is a perspective view showing the concept of a magnetism generating element 15A according to still another modified embodiment of the present invention.

The magnetism generating element 15A of this modified embodiment includes a magnetic core member 15Ab having an elongated rod shape or a linear shape (or may be a strip plate shape), and a hollow that is externally fitted to the magnetic core member 15Ab so as to be slidable in the longitudinal direction. The magnetic field shielding cylinder 15Aa made of a magnetic field shielding member.

The magnetic flux control means of this modified embodiment draws a linear member 15Ac inserted through an endoscope (not shown) and connected to the rear end of the magnetic field shield cylinder 15Aa to, for example, an operation portion of the endoscope (not shown). The magnetic flux intensity of the magnetism generating element 15A can be controlled by sliding the magnetic field shield cylinder 15Aa back and forth in the longitudinal direction with respect to the magnetic core member 15Ab by pulling or pushing the shaped member 15Ac. Therefore, the electric wiring of the magnetic flux radiating means is unnecessary, and the magnetic flux control means can be greatly simplified and the cost can be reduced.

FIG. 12 is a plan view showing a concept of a magnetism generating element 15B according to still another modified embodiment of the present invention.

The magnetism generating element 15B of this modified embodiment is obtained by wiring a fine wire 15Ba in a wavy line shape or a sine curve shape with a very short period, for example, on a semiconductor substrate 15Bb made of an elongated strip plate such as Si. The symbol 15Bc is a pair of lead wires connected to the conductive wire 15Ba.

Such a magnetism generating element 15B is applied to the magnetic flux radiation cylinder 10 (FIG. 3 etc.) of the first embodiment or one loop-shaped magnetic flux radiation means 10a (FIG. 9) of the second embodiment and is compact magnetic flux radiation. A means can be comprised and the increase in the pain in insertion in a patient's biomedical officer can be suppressed further.

FIG. 13 is an enlarged view of the distal end portion of the endoscope to which the magnetic flux radiation means (flux radiation cylinder) 10b showing the mounting concept of the magnetic flux radiation means

positioning angle sensors

48 and 49 according to another modified embodiment of the present invention is mounted. is there. In FIG. 13, members having the same function in the above-described embodiment, for example, in FIG.

In this modified embodiment,

angle sensors

48 and 49 using, for example, a known uniaxial to triaxial strain gauge are provided on the outer surface of the curved portion 42b adjacent to the distal end portion 41 of the endoscope 40, for example, at two positions perpendicular to the axis. Attached to the distal end portion 41 of the endoscope 40 by the magnetic flux radiation means positioning control unit 51 via

signals

48a and 49a from

angle sensors

48 and 49 for detecting the bending angle of the bending portion 42b. The bending drive unit (not shown) can be controlled to stop and hold at any desired bending angle position of the magnetic flux radiating tube 10 (see FIGS. 1 and 2 and FIG. 14 described later).

FIG. 14 shows a magnetic flux radiation means (flux radiation cylinder) 10 showing the concept of mounting magnetic flux radiation means positioning angle sensors (rotation angle sensors) 54 and 55 according to still another modified embodiment of the present invention. 2 is a perspective view of an endoscope 40. FIG. In FIG. 14, for example, members having the same functions as in FIG. 2, for example, are given the same reference numerals or symbols even if the shapes are partially different.

In this modified embodiment, the bending drive part of the endoscope 40 is accommodated inside a disk-shaped operation part main body 43a that is large enough to be grasped and held by a user with one hand, for example, the left hand. The base end portions of the pair of bending operation wires are wound and fixed, and the sprocket that pulls and relaxes the pair of bending operation wires, the motor that rotates the sprocket, and the sprocket and the motor are arranged between the motor and the motor. An electromagnetic clutch for cutting the driving force, an angle sensor 54 such as a rotary encoder for detecting the rotational position as a rotational position detecting means for the motor, and a clutch operation detection switch for detecting the operation of the electromagnetic clutch. A plurality of switches for controlling the operation of various functional units of the endoscope 40 along the outer peripheral surface of the operation unit main body 43a, for example, an air / water supply button, a suction button, a joystick device, a clutch switch 53, and a scope switch, all not shown An engagement switch or the like is provided. Here, a joystick device is disposed in the vicinity of the universal cord connecting portion at the upper end of the operation portion main body 43a. The clutch switch 53 is a switch that releases (disconnects) transmission of the driving force of the bending drive unit.

The motor, the angle sensor 54, and the clutch operation detection switch (not shown) are connected to the endoscope bending control unit 51a in the magnetic flux radiation means positioning control unit 51 through lines such as a control signal 54a. In addition, the bending drive unit is connected to an angle sensor 55 such as a potentiometer for detecting the rotation position as a rotation position detection means of the sprocket, and this angle sensor 55 is connected to the inside via a line of a control signal 55a. A rotational position signal indicating the rotational position of the detected sprocket is connected to the endoscope bending control unit 51a.

The magnetic flux radiating means positioning control unit 51 then controls the motor based on the

control signals

54a and 55a from the

angle sensors

54 and 55 as the rotational position detecting means according to the bending operation signal from the joystick device 52 as the bending operation input means. , And the bending portion 42b is electrically operated to bend and cooperate with an endoscope bending control unit 51a to stop at any desired bending angle position of the magnetic flux radiating means 10 attached to the endoscope distal end portion 41. And control to hold.

Furthermore, an engagement switch (not shown) is disposed in the vicinity of the joystick device 52. The engage switch is a push-type switch, and is set to perform a lock operation by one push and an unlock operation by another push. By operating the engagement switch, the movement of the joystick of the joystick device 52 is fixed, and the bending portion 42b is fixed (locked) at a desired bending angle. At this time, the joystick is tilted to input a bending operation, and normally, when the hand is released, the joystick is prevented from returning to the neutral state by the frictional force of the brake member. Can be fixed.

As illustrated and explained above, the angle sensor or / and position sensor for positioning the magnetic flux radiation means uses a mechanical type, a fluid type, an optical gyro, a vibration gyro, an accelerometer, a strain meter, a potentiometer, an encoder, etc. Various known angle and / or position sensors are applied and provided at appropriate positions of the endoscope 40 or / and the magnetic flux radiating means 10, and attached to the endoscope distal end portion 41 via the magnetic flux radiating means positioning control unit. The magnetic flux radiating means 10, 10a, 10b can be stopped and held at any desired bending angle position.

15A is a conceptual diagram of a magnetic anchor 20A according to another embodiment of the present invention, and FIG. 15B is a conceptual diagram of a magnetic anchor 20B according to still another embodiment. In FIG. 15, for example, members having the same functions as the

magnetic anchors

20, 20 ′, 20 ″, etc. in FIGS. is there.

15A and 15B, the

magnetic anchors

20A and 20B are each composed of at least two magnetic members 22A1, 22A2 and 22B1, 22B2 made of different materials in the longitudinal direction. This is different from the magnetic anchor of the above embodiment, and is formed in a substantially cylindrical shape and a substantially tapered cone shape, respectively.

In the

magnetic anchors

20A and 20B, the

magnetic members

22A and 22B are composed of at least two different kinds of magnetic members 22A1, 22A2, and 22B1, 22B2 in the longitudinal direction, and have the same S or N pole as the opposite magnetic flux radiating means. Since the magnetic members 22A1 and 22B1 of the

magnetic members

20A and 20B can be formed on the tip surfaces of the magnetic members, the repulsive force due to the magnetic flux from the opposing surface of the magnetic flux radiating means reaches the tip surfaces of the magnetic members 22A1 and 22B1 of the

magnetic anchors

20A and 20B, respectively. Therefore, it is possible to prevent the magnetic member tip portions 22Aa and 22Ba of the

magnetic anchors

20A and 20B from being inverted in the direction of the facing surface of the magnetic flux radiating means, and the reliability and safety of the ESD surgery are ensured.

16A is a conceptual diagram of a magnetic anchor 20C according to still another embodiment of the present invention, and FIG. 16B is a conceptual diagram of a magnetic anchor 20D according to still another embodiment.

The magnetic anchors 20C and 20D in the embodiment of FIGS. 16 (a) and 16 (b) are magnetic rotating members with respect to the magnetic anchors 20 ′ and 20 ″ according to the embodiment of FIGS. 6 (a) and 6 (b), respectively. Both 22Cc and 22Dc are the same except for the point that the magnetic fluid is sealed. Therefore, in FIG. 16, the members having the same functions as those of the magnetic anchors 20 ′ and 20 ″ in FIG.

The

magnetic members

22C and 22D of the magnetic anchors 20C and 20D respectively include a substantially cylindrical magnetic outer cylinder 22Ca connected to the engaging member 21, a substantially tapered and substantially conical hollow outer cylinder 22Da, and a magnetic outer cylinder. The magnetic body rotating members 22Cc and 22Dc are encapsulated in a magnetic fluid (also referred to as “magnetic fluid”) so as to be rotatable around central axes 22Cd and 22Dd.

This magnetic fluid is a magnetic colloid solution composed of ferromagnetic fine particles such as magnetite and manganese zinc ferrite, a surfactant covering the surface, and a base liquid (water or oil). Researched and developed by Papel for use in sealing materials for moving parts of spacesuits and for positioning objects in weightless environments, etc., and at the same time, Tohoku University, Shimoizaka et al. A publicly known report can be applied.

The ferromagnetic fine particles in the magnetic fluid maintain a stable dispersed state without agglomeration or settling in the base liquid due to the affinity between the surfactant and the base liquid and the repulsive force between the surfactants. The ferromagnetic fine particles have a diameter of about 10 nm, for example, and are as small as about 1/10 of the influenza virus. When the magnetic flux radiating means is brought close to the magnetic member that generates a magnetic field such as a permanent magnet at a close distance, a projection having an angle from the magnetic fluid is formed along the flow of the magnetic force lines. This is called a spike phenomenon, and the shape of the streamlined projection is very aesthetic, and it is also known that art works can be created using this phenomenon.

The

magnetic members

22C and 22D configured as described above rotate the magnetic body around the central axis once the magnetic rotating members 22Cc and 22Dc are applied with a finger or the like in the magnetic outer cylinders 22Ca and 22Da made of a magnetic material. The members 22Cc and 22Dc are always rotated so that a gyro moment is applied, and the

magnetic member

22C and 22D are moved from the distal end portions 22Caa and 22Daa toward the base end portions 22Cb and 22Db by the magnetic flux from the magnetic flux radiating means. Generation of a magnetic field gradient of the magnetic fluid in 22Cc and 22Dc also has a superposition effect, and the distal end portion 22Caa in which a different polarity with respect to the proximal end portion 22Cb of the magnetic member 22C is formed is attracted toward the distal end surface direction of the magnetic flux emitting tube 10. Inversion can be prevented.

In addition to this, the magnetic anchor 20D of still another embodiment is opposed to the entire outer peripheral surface of the tapered conical cylindrical magnetic outer cylinder 22Da that gradually expands from the base end 22Db to the front end 22Daa of the magnetic member 22D. Since the same S or N pole as the front end surface of the magnetic flux radiating means is formed, the electromagnetic repulsion force due to the magnetic flux from the front end surface of the magnetic flux radiating means extends to the outer peripheral surface of the end portion of the magnetic member 22D that gradually increases. Therefore, the effect of preventing the tip portion 22Daa of the magnetic member 22D having a different polarity (N or S pole) from being attracted in the tip surface direction of the magnetic flux radiating means from being reversed is also superimposed.

Note that the above description is merely an example, and when interpreting the present invention, there is no limitation or restriction on the correspondence between the items described in the embodiment and the items described in the claims.

The magnetic anchor attached to the lesioned part on the inner surface of the biological tube T of the present invention, the magnetic flux releasing means attached to the distal end portion of the endoscope, and the magnetic flux controlling means for controlling the distribution of the magnetic flux emitted from the magnetic flux releasing means from the outside. By using the ESD surgical system, the accurate field of view by the endoscope is sufficiently ensured. Therefore, the ESD surgical operation with an incision tool such as an electric scalpel can be easily and quickly performed. It is possible to realize a surgical system and surgical method for endoscopic submucosal dissection (ESD) that reduces surgical invasion, and is excellent in operability and reliability of surgery, and economical efficiency. Can contribute to breakthrough progress in the field.

10, 10b Magnetic flux radiation means (flux radiation cylinder)
10a Magnetic flux radiation means (looped magnetic coil)
11,

22'a Outer cylinder

11 ', 11'', 11a (Elastomer or resin-based material) thin film 12 Inner cylinder 13 Front end wall 14 Rear end wall 15 Magnetization element (magnetic coil)
15a, 16a Conductor coil 15b Magnetic core member 15c, 15Bc Lead wire 16 Magnetism generating element (looped magnetic coil)
17, 18 Angle sensor (eg gyro type)
17a, 18a, 48a, 49a, 54a, 55a Control signal 20, 20 ', 20'', 20A, 20B Magnetic anchor 21 Engaging member 21a Clip 22, 22', 22 '', 22A, 22A1, 22A2, 22B, 22B1, 22B2, 22C, 22D Magnetic member 22a, 22'aa, 22''aa, 22Aa, 22Ba, 22Caa, 22Daa Tip 22b, 22'b, 22''b, 22Ab, 22Bb, 22Cb, 22Db Base end 22'a, 22''a Magnetic outer cylinder 22'c, 22''c Magnetic rotating member 22'd, 22''d Central axis 22Cc, 22Dc Magnetic rotating member (magnetic fluid sealed)
22Cd, 22Dd Central axis 23 Connecting member 30, 30 'Foot operation part 31 Base 32, 32' Box body 33, 33 'Foot pedal 33a, 33'a Link pressing part 34 Universal support means 34' Pivot means 34a First support means Frame body 34'a Foot pedal side bracket 34b Second frame body 34c Third frame body 34'c Box body side bracket 34d Mounting portion 34d1 Hollow mounting portion 34d2 Sliding mounting portion 34d3 Elastic member (elastic mechanism)

34'e Pivot shaft

35, 36e Compression spring member 36 Variable electric resistance means 36a Guide frame

36b Sliding link

36c Support link

36d End bracket 40 Endoscope 41 Front end portion 42 Insertion portion 42b Bending portion 43 Operation portion 43a Operation portion main body 44 First treatment instrument guiding channel 45 Second treatment instrument guiding channel 46 Illumination window 47

Observation window

48, 49 Angle sensor (for example, strain gauge type)
DESCRIPTION OF SYMBOLS 50 Endoscope operation unit 51 Magnetic flux radiation means positioning control unit 51a Endoscope bending control unit 52 Joystick device 53 Clutch switch 54 Angle sensor (for example, rotary encoder type)
55 Angle sensor (eg potentiometer type)
60 Magnetic flux control unit 70 Magnetic flux control means Lc Electromagnetic coil lead wire cord Le Power cord Lr Variable electric resistance means lead wire cord M Magnetic flux Ra Electrical resistor Rb Sliding brush SW Power switch T Biological tube (digestive tract)
T1 muscle layer T2 mucosal layer T2a lesion

Claims

One or a plurality of magnetic anchors made of a small-diameter magnetic member connected to an anchoring member anchored to a lesion site on the inner surface of a living body tube;
Magnetic flux radiating means equipped with one or a plurality of sealed magnetism generating elements that are attached to the distal end of an endoscope that is inserted in the vicinity of a lesion site in the living body tube and that imparts an electromagnetic repulsive force to the magnetic anchor;
Magnetic flux control means provided outside the living body and controlling the distribution of the magnetic flux emitted from the magnetic flux radiation means from the outside,
The magnetic flux control means applies an electromagnetic repulsive force to the magnetic anchor, and pulls a lesion site attached to the engaging member in a direction to separate it from a muscle layer of a biological tube. A surgical operation system for endoscopic submucosal dissection (hereinafter referred to as ESD), characterized by controlling magnetic flux distribution from the outside.
Any desired bending angle of the magnetic flux radiating means mounted on the endoscope tip through one or more angle sensors or / and position sensors provided on the endoscope or / and the magnetic flux radiating means. The ESD surgical system according to claim 1, further comprising a magnetic flux radiation means positioning control unit that controls a bending drive unit provided in the endoscope so as to stop and hold the position.
The magnetic flux radiating means is
An inner cylinder made of a thin film of an elastomer or a resin-based material and detachably fitted to the outer diameter of the distal end portion of the endoscope;
A magnetic flux radiation cylinder comprising a plurality of elongated rod-like or strip-like magnetism generating elements arranged approximately equally in the circumferential direction on the outer circumference of the inner cylinder and provided along the axial direction,
3. The ESD surgical system according to claim 1, wherein the magnetism generating element is sealed with a thin film of an elastomer or a resin material.
The magnetic flux radiating means is
A magnetism generating element formed in the shape of a flexible elongated rod or strip is hermetically packaged with a thin film of elastomer or resin material, and is placed in the treatment instrument guide channel of the endoscope so that it can be pulled out from the distal end in a looped state. Is formed into a single loop,
The ESD surgical system according to claim 1 or 2, wherein the ESD surgical system is configured to be arranged in a loop so as to surround a lesion site to which the one or more magnetic anchors are attached.
The magnetism generating element is
The ESD surgical system according to any one of claims 1 to 4, comprising a conductive coil wound around an elongated rod-shaped or linear magnetic core member.
The magnetism generating element is
The ESD surgical operation system according to any one of claims 1 to 4, wherein an ultrathin conductive wire is printed and wired in a short-period wavy line or sine curve shape on an elongated strip-like semiconductor substrate.
The magnetism generating element is
An elongated rod-like or linear or strip-like magnetic core member;
5. The magnetic field shield tube comprising a hollow magnetic field shield member externally fitted to the magnetic core member so as to be slidable in the longitudinal direction. 5. ESD surgical system.
The magnetic member of the magnetic anchor is
2. The ED surgical operation system according to claim 1, wherein the outer shape is formed so as to gradually expand from a proximal end portion connected to the engaging member to a distal end portion.
The magnetic member of the magnetic anchor is
A small-diameter hollow cylindrical or tapered cone-shaped magnetic outer cylinder connected to the engaging member;
2. A surgical operation for ESD according to claim 1, comprising a solid or encapsulated magnetic fluid-like magnetic rotating member which is rotatably arranged around the central axis in the magnetic outer cylinder. system.
9. The ESD surgical system according to claim 1, wherein the magnetic member of the magnetic anchor is made of at least two different materials in the longitudinal direction.
2. The ESD surgical operation system according to claim 1, wherein the magnetic flux control means includes a foot operation unit that can be operated by an ESD surgeon with a foot during an operation.
The foot operation unit is
A bottomed box with an open top;
It can be tilted in any direction via a universal support means provided in a substantially central portion with the box body, and can be returned to its original posture by the elastic force of a plurality of compression spring members provided in the periphery thereof. A box cover-like foot pedal laid on top of the box body;
A plurality of variable electrical resistance means that are arranged substantially symmetrically corresponding to each magnetism generating element of the magnetic flux radiating means around the inside of the bottom surface of the box body, and the electrical resistance changes in conjunction with the tilting operation of the foot pedal; The ESD surgical system according to claim 11, further comprising:
The foot operation unit is
A bottomed box with an open top;
The box body is pivotally supported so as to be able to tilt forward between the rear end portions thereof, and is covered on the upper portion of the box body so that the original posture can be returned by the elastic force of the compression spring member provided between the front end portions. A box-covered foot pedal,
The ESD surgical system according to claim 11, further comprising variable electrical resistance means that is disposed in a bottom surface of the box body and changes electrical resistance in conjunction with a tilting operation of the foot pedal.
The magnetic flux control means receives a voltage signal from each variable electrical resistance means of the foot operation unit connected to a power source, and controls a current value to each magnetism generating element of the magnetic flux radiation means to control the magnetic flux of the magnetic flux radiation means. The ESD surgical system according to claim 12 or 13, further comprising a magnetic flux control unit for controlling distribution.
Each of the variable electrical resistance means includes
An electrical resistor of an appropriate length attached to the inside of the bottom surface of the box body;
A sliding brush that slides longitudinally over the electrical resistor;
A sliding link having a base end pivotally supported by the sliding brush;
A base link is pivotally supported by an end bracket provided on the inner side of the bottom surface of the box body, and a distal end of the support link is pivotally supported by the distal end of the sliding link;
A return spring member suspended between the base end portion of the sliding link and the base end portion of the support link or the bottom surface of the box body to bend and hold both links in a square shape,
In conjunction with the tilting movement of the foot pedal, the tip ends of both links are pressed against the ceiling inner surface of the foot pedal and swing, so that the sliding brush slides in the longitudinal direction on the electric resistor and the electric resistance is variable. The ESD surgical operation system according to any one of claims 12 to 14, wherein the ESD surgical system is performed.
The universal support means is:
A first frame that is fixed to a substantially central portion of the inner surface of the ceiling or the bottom surface of the box body;
A second frame pivotally supported by the first frame so as to be swingable about the X axis in the front-rear direction of the foot pedal;
A third frame pivotally supported about the Y axis in the left-right direction of the foot pedal orthogonal to the X axis on the second frame,
13. The ESD surgical system according to claim 12, wherein the attachment portion of the third frame body is composed of a gimbal mechanism fixed to the bottom surface of the box body or the substantially central portion of the ceiling inner surface of the foot pedal. .
The ESD surgical operation system according to any one of claims 11 to 16, wherein an upper surface of the foot operation unit is an inclined surface having an upward slope toward the front.
The magnetic flux control means includes
By sliding the magnetic field shield cylinder back and forth in the longitudinal direction with respect to the magnetic core member through a linear member inserted into the endoscope and connected to a rear end portion of the magnetic field shield cylinder, the magnetic field The ESD surgical system according to claim 7, wherein the magnetic flux distribution of the generating element is controlled.
One or more magnetic anchors, each of which has a small-diameter magnetic member connected to an engaging member for engaging a biological tissue, are attached to a lesion site on the inner surface of the living body tube via the engaging member,
A magnetic flux radiating means including one or a plurality of sealed magnetism generating elements for applying an electromagnetic repulsive force to the magnetic anchor is attached to the distal end portion of the endoscope, and the distal end portion of the endoscope is attached to the living body tube. Insert the magnetic flux radiation means to the magnetic anchor and insert it to the vicinity of the lesion as appropriate,
The magnetic flux distribution from the magnetic flux radiating means is controlled by the magnetic flux control means for controlling the distribution of the magnetic flux radiated from the magnetic flux radiating means from the outside of the living body, and an electromagnetic repulsive force is applied to the magnetic anchor to engage the magnetic anchor. Performing submucosal detachment of the lesion site using an incision tool from the treatment instrument guide channel at the distal end of the endoscope, while pulling the worn lesion site away from the muscle layer of the biological duct Surgical method for ESD.
Through one or a plurality of angle sensors or / and position sensors provided on the endoscope or / and the magnetic flux radiation means, the magnetic flux radiation means mounted on the endoscope distal end portion can be in any desired curved angular position. 20. The ESD surgical method according to claim 19, further comprising a magnetic flux radiation means positioning control unit for controlling a bending drive unit provided in the endoscope so as to be stopped and held.
The magnetic flux radiating means is
An inner cylinder made of a thin film of an elastomer or a resin material and detachably fitted to the outer diameter of the distal end portion of the endoscope;
A magnetic flux radiation cylinder comprising a plurality of elongated rod-like or strip-like magnetism generating elements arranged substantially equally in the circumferential direction on the outer circumference of the inner cylinder and provided along the axial direction,
21. The ESD surgical method according to claim 19 or 20, wherein the magnetism generating element is sealed with a thin film of an elastomer or a resin material.
The magnetic flux radiating means is
A magnetism generating element formed in the shape of a flexible elongated rod or strip is hermetically wrapped with a thin film of elastomer or resin material, and placed in the treatment instrument guide channel of the endoscope so that it can be pulled out from the distal end in a looped state. Formed into a single loop,
21. The ESD surgical method according to claim 19 or 20, wherein the ESD surgical method is configured to be arranged in a loop so as to surround a lesion site to which the one or more magnetic anchors are attached.
The magnetism generating element is
The surgical method for ESD according to any one of claims 19 to 22, comprising a conductive coil wound around an elongated rod-shaped or linear magnetic core member.
The magnetism generating element is
23. The ESD surgical method according to any one of claims 19 to 22, wherein an ultrathin conductor is printed and printed in a short-period wavy line or sine curve shape on an elongated strip-like semiconductor substrate.
The magnetism generating element is
An elongated rod-like or linear or strip-like magnetic core member;
23. The ESD according to any one of claims 19 to 22, comprising a magnetic field shielding cylinder comprising a hollow magnetic field shielding member externally fitted to the magnetic core member so as to be slidable in the longitudinal direction. Surgical methods.
The magnetic member of the magnetic anchor is
20. The ESD surgical method according to claim 19, wherein the outer shape is gradually enlarged from the proximal end portion connected to the engaging member toward the distal end portion.
20. The ESD surgical method according to claim 19, wherein the magnetic flux control means includes a foot operation unit which can be operated by an ESD surgeon with his / her foot during the operation.
The foot operation unit is
A bottomed box with an open top;
It can be tilted in an arbitrary direction via a universal support means provided in a substantially central portion between the box body and the original posture can be restored by the elastic force of a plurality of compression spring members provided in the periphery thereof. A box cover-like foot pedal covering the top of the box body;
A plurality of variable electric resistance means arranged substantially symmetrically corresponding to each magnetism generating element in the magnetic flux radiating tube around the bottom surface of the box body and changing the electric resistance in conjunction with the tilting operation of the foot pedal; 28. The ESD surgical method according to claim 27, further comprising:
The foot operation unit is
A bottomed box with an open top;
A box cover that is pivotally supported between the rear end portion of the box body so as to be able to tilt forward and is recovered to the original posture by the elastic force of a compression spring member provided between the front end portions. Shaped foot pedal,
28. The ESD surgical method according to claim 27, further comprising: variable electric resistance means that is disposed within a bottom surface of the box body and changes electric resistance in conjunction with a tilting operation of the foot pedal.
The magnetic flux control means includes
A magnetic flux control unit for controlling the distribution of magnetic flux of the magnetic flux radiating means by receiving a voltage signal from each variable electric resistance means of the foot operation unit connected to a power source and controlling the current value to each magnetism generating element of the magnetic flux radiating means. 30. The ESD surgical method according to claim 28 or 29, further comprising:
31. The ESD surgical method according to any one of claims 27 to 30, wherein the foot operation unit has an upper surface that is inclined upwardly toward the front.
The magnetic flux control means includes
The magnetic field is generated by sliding the magnetic field shield cylinder back and forth with respect to the magnetic core member through a linear member that is inserted into the endoscope and connected to a rear end portion of the magnetic field shield cylinder. 24. The ESD surgical method according to claim 23, wherein the magnetic flux distribution of the elements is controlled.