1. Filed of the Invention
The invention relates to a high frequency treatment tool that can be used for treatment such as removal of a diseased mucous membrane by incising and exfoliating it by being inserted in a treatment tool insertion channel of an endoscope, and can supply a biocompatible liquid such as normal saline solution, sodium hyaluronate, or glyceol, and to a mucous membrane exfoliation method that is carried out by using this high frequency treatment tool.
2. Description of the Related Art
When a diseased portion such as a tumor is found on the mucous membrane on the body cavity inner wall of the gullet, the stomach, the duodenum, the colon, or the like by an endoscopic examination, treatment is performed to excise the diseased mucous membrane. One of such treatment is called endoscopic submucosal dissection (ESD). This ESD is normally carried out as follows. First, the portion of the mucous membrane to be excised is marked, and the portion of the diseased mucous membrane is bulged by means of local injection. In this state, the mucous membrane is incised along the marking by using a high frequency treatment tool and the fibers of the submucosal layer are cut and the mucous membrane is exfoliated from the muscle layer.
The high frequency treatment tool to be used for the above-described treatment is formed by attaching a high frequency knife including an electrode member having a bar-shaped portion inside a flexible sheath. To the base end of the flexible sheath, operating means is joined, and by this operating means, the high frequency knife is stuck out from the front end of the flexible sheath. By energizing the high frequency knife, the mucous membrane can be incised and exfoliated. As the knife of the high frequency treatment tool to be used for this ESD, there are available a needle-shaped knife including an electrode member extending straight, and a hook knife having a hook portion formed by providing a large-diameter electrode portion continuously from the front end of the bar-shaped electrode member or bending the front end into a roughly L shape. The needle-shaped knife is most suitable for piercing the mucous membrane, and the mucous membrane can be incised or exfoliated by horizontally moving and swinging the electrode member. On the other hand, the hook knife incises or exfoliates the mucous membrane by hooking the mucous membrane on the hook portion on the front end and drawing it.
The muscle layer is under the mucous membrane, and to carry out the treatment, the high frequency knife must be operated so as not to damage this muscle layer, that is, so as not to come into contact with the muscle layer when the high frequency knife is energized. Therefore, the high frequency knife, in particular, the front end of the high frequency knife must always be captured within the observation field of the endoscope. However, the needle-shaped knife is inserted into the mucous membrane, so that depending on the circumstances, the front end comes out of the observation field of the endoscope, so that it is difficult to perform treatment while completely preventing the front end of the needle-shaped knife from coming into contact with the muscle layer. On the other hand, in the case of using the hook knife, the hook knife is hooked on the mucous membrane under observation with the endoscope, drawn into the treatment tool insertion channel, and energized to cut the tissue, whereby incising or exfoliating the mucous membrane. Therefore, the hook knife can be operated under observation with the endoscope, and it does not come into contact with the muscle layer in an energized state, so that the method using the hook knife is superior in terms of treatment safety.
JP-A-2004-313537 proposes a hook knife provided with a mechanism for more stably retaining the position of the front end of the hook knife when hooking. In the high frequency treatment tool of JP-A-2004-313537, an electrical insulating member is attached to the front end of the flexible sheath, and a through hole is made in the electrical insulating member, and the bar-shaped portion of the electrode member of the hook knife is inserted in this through hole, and the hook portion on the front end can come into contact with and separate from the front end outer surface of the electrical insulating member. When energized, the electrode member is stuck out a predetermined length from the flexible sheath, and the diameter difference between the diameter of the through hole and the diameter of the electrode member is minimized, and the sticking-out length of the electrode member is restricted, whereby the electrode member is stably retained. In the maximum sticking-out state of the electrode member, at least the hook portion is set so as to be captured in the observation field of the endoscope.
As described above, by stably retaining the portion of the electrode member stuck-out from the flexible sheath, the direction of the electrode member can be easily controlled, and this is advantageous for safe operation for hooking and cutting the tissue. However, the operation for hooking the mucous membrane and the submucosal layer by the hook knife of the electrode member and drawing the knife into the treatment tool insertion channel while energizing to cut the tissue and leading the hook knife out from the treatment tool insertion channel is repeatedly performed, so that the operation efficiency and swiftness are not obtained. Therefore, the treatment of removing the diseased mucous membrane takes a long time and accordingly increases the pain of the examinee being subjected to treatment and the burden on the operator. The hook portion is always exposed to the outside, and for example, during insertion into the treatment tool insertion channel, if the electrode member is energized by mistake, it may damage the channel inner wall.
The invention was developed in view of the above-described circumstances, and an object thereof is to provide a high frequency treatment tool with which treatment such as incision and exfoliation of the mucous membrane can be safely, swiftly, and efficiently performed, and a treatment method using this high frequency treatment tool.
In order to achieve the above-described object, a high frequency treatment tool to be inserted in a body cavity via a treatment tool insertion channel of an endoscope, comprises: a flexible sheath capable of being inserted in the treatment tool insertion channel; a treatment tool main body comprising a flexible cord and a straight electrode member that can apply a high frequency current on the front end of the flexible cord, the treatment tool main body being provided inside the flexible sheath; a stopper member comprising an electrical insulating material, the stopper member being attached inside the flexible sheath and disposing its front end face at almost the same position as a front end of the flexible sheath so as to form a front end reference face; an insertion hole that is formed so as to penetrate the stopper member in its axial direction, and in which the electrode member is to be inserted; an operating section that is connected to a base end of the flexible cord and reciprocates the electrode member between a state that the electrode member is stuck out from the front end reference face and a state that the electrode member is withdrawn into the insertion hole by pushing or pulling the treatment tool main body within the flexible sheath; a restricting member that is provided at or near a connecting portion between the flexible cord and the electrode member and can come into contact with and separate from a base end of the stopper member to restrict the maximum sticking-out length of the electrode member from the front end reference face; and a fluid channel that is provided at the stopper member and makes a fluid to flow out from the front end face.
The high frequency treatment tool is inserted in the treatment tool insertion channel of the endoscope, and treatment such as incision and exfoliation of the mucous membrane is performed, however, capturing of the front end of the electrode member provided at the front end of the treatment tool main body in the observation field of the endoscope is not essential for safety of the treatment. By adjusting the sticking-out length of the electrode member from the flexible sheath so as not to come into contact with the muscle layer when the front end of the electrode member penetrates the mucous membrane, the front end of the electrode member being unable to be recognized does not especially pose a problem as long as the front end of the flexible sheath is captured in the observation field of the endoscope.
Herein, the treatment of excision of the diseased mucous membrane is effective in the case where the surface of the mucous membrane is diseased and the diseased portion does not infiltrate into the submucosal layer. The submucosal layer is between the mucous membrane and the muscle layer. Therefore, when excising the mucous membrane, the entire region of the diseased mucous membrane must be removed.
By considering these points, the front end face of the flexible sheath is formed so as to come into contact with the mucous membrane surface, and the sticking-out length of the electrode member from the front end face of the flexible sheath is set so as not to reach the muscle layer although it penetrates the mucosal layer, whereby safe treatment is possible and the mucosal layer can be exfoliated without fail, and the muscle layer is not damaged. A restricting member provided on the treatment tool main body comes into contact with a stopper member attached to the front end of the flexible sheath to restrict the maximum sticking-out length of the electrode member. Therefore, the straight electrode member, that is, the electrode member having the shape of the needle-shaped knife can be used, and with this, by horizontally moving and swinging the electrode member without hooking, incision and exfoliation can be performed swiftly and efficiently. Herein, depending on the organ to be treated, the thicknesses of the mucous membrane and the submucosal layer are different. Therefore, it is desirable that a plurality of types of electrode members with different maximum sticking-out lengths are prepared according to the portion to be treated. By making the position of the stopper member or the restricting member adjustable, the maximum sticking-out length of the electrode member can be changed according to the portion to be treated, however, by considering danger in treatment in a state from failing to adjust, such an adjusting mechanism is not provided.
To stably retain the front end face of the flexible sheath in contact with the mucous membrane surface, the front end of the flexible sheath must have a wide face. The front end face of the stopper member is set as a front end reference face by facing it with the position of the front end of the flexible sheath, and thereby, a wide front end reference face is formed by the end face of the flexible sheath and the end face of the stopper member. As a result, when the front end reference face is made contact with the mucous membrane, the pressure per unit area can be reduced, so that the mucous membrane can be retained without great deformation. Even when a difference in level is formed between the front end of the flexible sheath and the front end of the stopper member, if the difference is slight, it does not functionally pose a problem.
The electrode member is straight, so that it can be stuck out from and withdrawn into the insertion hole of the stopper member. The stopper member is made of an electrical insulating material, so that when the high frequency treatment tool is inserted in the treatment tool insertion channel, by drawing the electrode member to the position to the base end side through the insertion hole, the inner surface of the treatment tool insertion channel is prevented from being damaged even when the power source is actuated by mistake and the electrode member is energized. The stopper member can be made of, for example, plastic as long as it has electrical insulation, however, there is a possibility that the electrode member generates heat when the electrode member is stuck out from the stopper member and a high-frequency current is supplied, so that the stopper member is desirably made of ceramic in terms of heat resistance and shape retention.
When the treatment such as incision and exfoliation of the mucous member is not performed, the electrode member is retained in a state that it is not stuck out from the stopper member, however, if the flexible sheath is bent, the treatment tool main body moves axially inside. As a result, the front end of the electrode member may stick out from the front end face of the stopper member although this is not intended. To retain the electrode member in the non-sticking-out state without fail, the stopper member is lengthened and the insertion hole is lengthened, however, it is desirable that the electrode member is positioned more inwardly than the stopper member attached to the flexible sheath. To reliably guide the electrode member drawn-in from the stopper member into the insertion hole when it is stuck out, a draw-in tapered portion for drawing the electrode member into the insertion hole is provided on the base end face of the stopper member. By providing a center alignment function between the electrode member and the insertion hole, the electrode member can be guided into the insertion hole. For this, the difference of the outer diameter of the restricting member from the inner diameter of the flexible sheath is reduced, in detail, the clearance between the restricting member and the inner surface of the flexible sheath is set to be smaller than the clearance between the electrode member and the insertion hole, and some degree of length is secured axially. However, if the restricting member is made of a hard material, it becomes unbendable. By forming the restricting member of, for example, a close coil spring, it becomes bendable. Against the stopper, the restricting member is pressed, so that the stopper member is desirably firmly fixed to the flexible sheath so as not to come off the flexible sheath. The stopper member is fixed by means of bonding to the inner surface of the flexible sheath, however, to increase the fixing strength, for example, the base end side outer circumferential surface of the stopper member to be inserted in the flexible sheath is increased in diameter to form a stepped structure.
The high frequency treatment tool has a liquid supply means. To bulge the diseased mucous membrane, a biocompatible liquid such as normal saline solution, sodium hyaluronate, or glyceol is locally injected, and the same liquid as this locally injected liquid is supplied. Particularly, normal saline solution infiltrates into the body and flows out during operation, so that the bulging portion shrinks after a certain time elapses, and the bulging portion disappears soon. By considering this point, the liquid supply means is used as replenishing means for maintaining the bulging portion formed by local injection. In detail, for example, a pipe-shaped member is joined to the base end of the flexible sheath, and this joined pipe is provided with a liquid feed means connecting portion. The liquid is jetted from the front end reference face. The liquid can be efficiently replenished to a target portion of the submucosal layer by jetting it with a high pressure while making the front end reference face contact with the mucous membrane or the submucosal layer exposed by incising the mucous membrane. The stopper member is contacted with the restricting member, so that one or a plurality of grooves are provided on the outer circumferential surface of this stopper member so as to serve as liquid jetting paths. To prevent the jetting paths from being clogged by the restricting member, the outer diameter of the restricting member is made smaller than the outer diameter of the stopper member. Thereby, the grooves are reliably communicated with the passage inside the flexible sheath.
There is preferably provided the high frequency treatment tool described above, wherein a body cavity inner wall of the body cavity comprises a mucosal layer, a submucosal layer and a muscle layer in this order from a surface of the body cavity, and the maximum sticking-out length of the electrode member from the front end reference face is set equal to or more than a thickness of the mucous layer and equal to or less than a depth from a surface of the mucous layer to the muscle layer. Namely, the maximum sticking-out length is usually from 0.5 mm to 4 mm, and is preferably from 1 mm to 3 mm.
There is also preferably provided the high frequency treatment tool described above,
wherein a front end of the electrode member has a displacement stroke from: a maximum position at which the electrode member has the maximum sticking-out length; to a minimum position at which the front end of the electrode member is withdrawn from a base end of the stopper member to a base end side of the high frequency treatment tool.
There is also preferably provided the high frequency treatment tool described above, wherein on the base end face of the stopper member, a draw-in tapered portion is provided for drawing the electrode member in the insertion hole.
There is also preferably provided the high frequency treatment tool described above, wherein the stopper member comprises ceramic, a diameter of the insertion hole is set so that the electrode is inserted therein without substantial gaps, the flow channel is formed by one or a plurality of grooves formed on an outer circumferential surface of the stopper member, and an outer diameter of the restricting member is set smaller than an outer diameter of the stopper member.
As a method of the invention for partially removing the mucosal layer of the body cavity inner wall under observation with an endoscope by using the high frequency treatment tool constructed as described above, there is provided a mucous membrane exfoliation method using a high frequency treatment tool, for partially removing a mucosal layer of a body cavity inner wall under observation with an endoscope, the body cavity comprising the mucosal layer, a submucosal layer and a muscle layer in this order from a surface of the body cavity, the method comprising: the steps of: bulging the mucosal layer to be removed by injecting a biocompatible liquid into the submucosal layer via an injection needle; inserting a high frequency treatment tool into the body cavity via a treatment tool insertion channel of the endoscope, wherein the high frequency treatment tool comprises: a flexible sheath; and a treatment tool main body including a flexible cord and an electrode member on a front end of the flexible cord, the treatment tool main body being capable of reciprocating by a predetermined stroke inside the flexible sheath, and a supply flow channel for the biocompatible liquid is provided in the flexible sheath; incising the mucous layer by making a front end face of the flexible sheath contact with a surface of the mucosal layer while restricting a maximum sticking-out position of the electrode member in the movement stroke of the treatment tool main body to a length that prevents the electrode member from reaching the muscle layer from the front end face of the flexible sheath, and applying a high frequency current to the electrode member sticking-out from the front end face; exfoliating the submucosal layer by inserting the electrode member between the mucosal layer and the muscle layer from the incised portion of the mucous layer; and replenishing the biocompatible liquid by jetting the biocompatible liquid from the front end of the flexible sheath via the supply flow channel during incision and exfoliation of the mucosal layer.
Hereinafter, embodiments of the invention will be explained with reference to the drawings. First,
As clearly seen in
At the shift portion from the flexible cord 11 to the electrode member 13 in the treatment tool main body 10 or at the portion of the electrode member 13, a restricting member 16 is attached. The restricting member 16 is larger in diameter than at least the insertion hole 15, and therefore, when the treatment tool main body 10 is advanced inside the flexible sheath 2 and the electrode member 13 sticks out by a predetermined length from the front end reference face F, the restricting member 16 comes into contact with the stopper member 14 and restricts the electrode member 13 from sticking out more. That is, the maximum sticking-out position of the electrode member 13 is regulated.
Furthermore, this high frequency treatment tool 1 has means for supplying a biocompatible liquid, for example, normal saline solution. This supply means has, as clearly seen in
The normal saline solution can be jetted forward from the front end of the flexible sheath 2. Therefore, as shown in
The high frequency treatment tool 1 constructed as described above is inserted in a body cavity via the treatment tool insertion channel C provided in the endoscope inserting portion S having an observing portion W as shown in
First, as shown in
In this state, the operating means 4 of the high frequency treatment tool 1 is operated to stick-out the electrode member 13 and apply a high frequency current to this electrode member 13. As a result, the portion of the mucous membrane in contact with the electrode member 13 is cauterized, where by marking is performed. At the time of this marking, the electrode member 13 need not penetrate the mucosal layer, and the mucous membrane surface is cauterized to a degree to make it possible to recognize it from an image obtained through an observation part W of the endoscope inserting portion S. Namely, when the electrode member 13 is made contact with the mucous membrane surface, marking is formed. Of course, even when the operating means 4 is moved by a full stroke and the electrode member 13 is at the position of maximum sticking-out from the flexible sheath 2, the electrode member 13 is unlikely to come into contact with the muscle layer. The marking can be formed by using another treatment tool, and it is not necessary to employ the above-described cauterization as long as the region of the mucous membrane to be excised can be recognized through the observation part W.
Next, normal saline solution is locally injected into the diseased mucous membrane region A as shown in
After sufficiently bulging the submucosal layer LM, the local injecting means is extracted from the treatment tool insertion channel C and the high frequency treatment tool 1 is inserted again. Then, the front end reference face F formed by the front end faces of the flexible sheath 2 and the stopper member 14 of the high frequency treatment tool 1 is made contact with any portion of the outer edge of the diseased mucous membrane region A. Herein, the front end reference face F is made to correctly face the mucosal layer LU, and the front end reference face F is slightly pressed against the mucous membrane surface while the pressing force is minimized.
Then, the operating means 4 is operated to stick the electrode member 13 out from the front end of the stopper member 14 and supply a high frequency current to the electrode member 13 during the sticking-out operation. When the electrode member 13 sticks out most, as shown in
Only by incising all the circumference of the diseased mucous membrane region A, the mucosal layer LU cannot be removed. Namely, the mucous layer LU and the muscle layer LB are linked by the fibered submucosal layer LM, so that it is necessary to cut the fibers to exfoliate the layer from the muscle layer LB. This exfoliation of the mucous membrane can be performed by using the high frequency treatment tool 1. Namely, as shown in
When performing the exfoliation of the mucous membrane, normal saline solution needs to be replenished. The diseased mucous membrane region A has already been bulged by locally injecting the normal saline solution, however, the normal saline solution supplied may flow out or may be absorbed by the body during incision and the bulged portion may contract. Therefore, to maintain the bulged state of the submucosal layer LM, the exfoliation of the mucous membrane is performed while replenishing the normal saline solution. This replenishment of the normal saline solution is also performed through the replenishing grooves 21 provided in the outer circumference of the stopper member 14. At this time, preferably, the electrode member 13 is drawn into the insertion hole 15 of the stopper member 14, and while the front end reference face F is made contact with the submucosal layer LM, the normal saline solution is jetted into the flexible sheath 2 from the connection port 3a of the connecting pipe 3. As a result, the solution can be directly injected toward the submucosal layer LM. As a result, the submucosal layer LM to be exfoliated can be maintained in the bulged state. Thus, replenishment of the normal saline solution does not require the troublesome operation of extracting the high frequency treatment tool 1 inserted in the treatment tool insertion channel C and inserting an injection needle instead, so that the exfoliation of the mucous membrane is not interrupted. Therefore, in this point, the treatment is improved in efficiency and swiftness. In addition, no member sticks out from the front end reference face F, so that the front ends of the grooves 21 can be made contact with the submucosal layer LM, and the normal saline solution can be accurately supplied to a necessary portion. Thereby, the submucosal layer LM can be reliably maintained in a bulged state, and the exfoliation of the mucous membrane can be safely and swiftly performed with the electrode member 13.
Herein, the stopper member is fixed in the front end portion of the flexible sheath so that the front end face of the flexible sheath and the front end face of the stopper member becomes the same surface. Therefore, like the stopper member 30 shown in
Thereby, when a force is applied in the direction of extracting the stopper member 30 from the flexible sheath 31, the stopper member 30 exerts an anchoring function due to the step 30a on the outer circumferential surface thereof biting into the inner surface of the flexible sheath 31. To more firmly fix the stopper member 30, the outer surface can be fixed to the inner circumferential surface of the flexible sheath 31 by using an adhesive, and furthermore, a screw portion is allowed to be formed on the outer circumferential surface of the stopper member 30. In the figure, the reference numeral 32 denotes the electrode member and 33 denotes the insertion hole formed in the stopper member 30.
As shown in
The restricting member is for restricting the sticking-out length of the electrode member in principle, and exerts a guide function for extending the electrode member straight. To restrict the sticking-out length of the electrode member, the restricting member has an outer diameter larger than the diameter of the insertion hole of the stopper member. To guide the electrode member, the length of the restricting member is necessary.
Therefore, as shown in
By using the above-described construction, exfoliation of the mucous membrane can be smoothly, reliably, and efficiently performed.
The entire disclosure of each and every foreign patent application from which the benefit of foreign priority has been claimed in the present application is incorporated herein by reference, as if fully set forth.
Number | Date | Country | Kind |
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P. 2005-151795 | May 2005 | JP | national |