Clip-on traction device

Abstract

To provide a treatment instrument that can achieve both of internal traction and extracorporeal traction when performing endoscope treatment.SOLUTION: A clip-type traction instrument is the instrument for performing pinch / traction of at least an intra-body lesion region under an endoscope. (1) The instrument has a clip part comprising (a) a pinching part capable of opening / closing or closing in a shape of scissors and (b) tightening means to open and close the pinching part. (2) The instrument is connected with 1 or 2-pieces or more of threadlike members each having a loop part in a tail part across from the pinching part of the clip part. (3) a) The connection between the tail part and threadlike member and / or b) the connection between the threadlike members can be disconnected by opening the ring of the loop part of the threadlike member.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to a novel clip-type traction device. [Background technology]

[0002] In recent years, endoscopic surgery (endoscopic surgery) using an endoscope has been widely used instead of open surgery, for reasons such as the relatively small burden on the patient and the small surgical incision. For example, in the esophagus, stomach, large intestine, etc., for early cancer that remains localized without metastasis, a method is adopted in which a treatment tool is guided to the lesion site through the treatment tool insertion passage of an endoscope and the localized lesion site is excised from the mucosa.

[0003] Such endoscopic resection techniques are broadly divided into three types: a) polypectomy, b) endoscopic mucosal resection (EMR), and c) endoscopic submucosal dissection (ESD).

[0004] Of these, method a) above is a method in which a metal ring called a snare is used to tighten around mushroom-shaped tumors, polyps, etc., and then the tumor is either burned off using high-frequency current or physically squeezed out without using high-frequency current.

[0005] The above method b) is used when it is difficult to snare the affected area, such as in the case of a flat tumor. In this method, saline or other liquid is injected into the submucosal layer of the affected area to raise the affected area, and a snare is then placed on that area, after which it is either burned off using high-frequency current or physically squeezed out without using high-frequency current.

[0006] The above method c) is used when the lesion is large (usually 2 cm or more) and it is difficult to use a snare, and the lesion is excised while peeling off the submucosal layer using a high-frequency knife.

[0007] Among these, in particular in the above c) endoscopic submucosal dissection (ESD), in order to completely remove the diseased tissue together with the surrounding non-diseased tissue, only the mucosal layer, which is the surface layer of the digestive tract, is incised around the diseased tissue (mucosal layer incision), the submucosal layer is fully exposed, and then the submucosal layer is dissected from the muscularis propria layer located further below (submucosal dissection) to remove the lesion. In other words, the submucosal dissection is performed following the mucosal layer incision. More specifically, the procedure is performed through the following steps.

[0008] [Step 1] An endoscope is inserted into the digestive tract from outside the body, reached to the target site for resection, and the extent of resection is determined. [Step 2] The mucosal layer, which is the superficial layer of the digestive tract wall, is incised to expose the submucosal layer so that the entire area can be removed without leaving any residue. [Step 3] The submucosa is peeled off with great care so as not to damage the muscularis propria layer underneath the submucosa. Then, steps 1 to 3 are repeated to completely remove the lesion.

[0009] However, in general, bleeding or perforation may occur as an accident when dissecting the submucosal layer, and in the case of the esophagus, pneumomediastinum may occur, which may be life-threatening. In particular, in step 3 above, when dissecting the submucosal layer, part of the mucosal layer in the process of resection covers the dissection operation site, making it difficult or impossible to directly view the resection site, which may result in perforation due to damage to the proper muscular layer, as well as bleeding due to blood vessel damage. Therefore, to perform ESD safely and reliably, the practitioner must have a certain level of experience and advanced skills.

[0010] When excising diseased tissue by surgical laparotomy, one end of the diseased tissue can generally be grasped and fixed with the left hand, so the diseased tissue can be resected reliably and accurately with the right hand, which is the dominant hand. In contrast, when excising diseased tissue by normal ESD, if the dissection tool guided from the inside of the endoscope's treatment tool insertion passage is in the right hand, there is no treatment tool that corresponds to the surgeon's left hand, so to speak, to grasp and fix. Therefore, if it is in its current state, the diseased tissue must be excised in an unfixed state. In addition, there are situations in which dissection and excision must be performed blindly because part of the diseased tissue during the resection process covers and hides the resection surface. Therefore, in ESD, if blood vessels are damaged by blind dissection operations, bleeding may occur, and if the resection and dissection surface becomes deeper than necessary, perforation may occur. When such problems occur, it is difficult to ensure a sufficient field of view, making it difficult to recover, and the procedure is often difficult or delayed, leading to life-threatening situations.

[0011] Therefore, in ESD and the like, a method called clip traction has been proposed to use the surgeon's left hand to traction and fix the diseased tissue during the resection process (Non-Patent Documents 1-3). This is a method in which the process of resecting the diseased tissue is temporarily stopped and the endoscope is removed from the body, and then a clip is attached to the forceps passed through the treatment tool insertion passage of the endoscope in advance, and the clip is reinserted into the body with a thread tied to it, and the diseased tissue is grasped and fixed with the clip as it is. According to this method, the surgeon traction the diseased tissue (site to be resected) while manipulating the other end of the thread that is outside the body and independent of the endoscope and outside the treatment tool insertion passage of the endoscope.

[0012] There is also a method in which the diseased tissue is grasped with a clip with a thread attached while passing through the endoscopic treatment tool insertion passage, the endoscope is then removed from the body, and then the endoscope is reinserted to the diseased area independently of the clip with the thread attached that grasped the diseased tissue (Patent Document 1, Non-Patent Document 4).

[0013] However, in this type of clip traction method, a conventional endoscope model having only one treatment instrument insertion passage is used, and the treatment instrument insertion passage is occupied by the device used for mucosal layer incision performed prior to the submucosal dissection operation.

[0014] In order to grasp the traction member protruding from the outside of the endoscope over its entire length with another clip forceps, the clip forceps must be attached to a traction member independent of the endoscope insertion passage while passing through the treatment tool insertion passage of the endoscope. Therefore, in order to attach the clip forceps, the endoscope must be removed from the body once as described above. In particular, in situations where insertion itself is not necessarily easy, such as the large intestine, the endoscope must be removed once, the clip forceps must be inserted through the treatment tool insertion passage, a suture must be attached, and then the endoscope must be reinserted, which imposes a heavy burden on both the therapist and the patient. In addition, since this process of removal and reinsertion takes a certain amount of time, it is difficult to use the conventional clip traction method in emergency situations, such as when it is necessary to traction the lesion site during bleeding, unfold the bleeding area, and directly view it.

[0015] On the other hand, as a traction method that does not require the removal and reinsertion of the endoscope, a method of performing ESD using a member with a nylon loop attached to the gripping part (wing part) of the clip has been proposed (Non-Patent Document 5). In this method, as a method of performing traction from inside the body, a clip 30 including a clamping part 11 that can be closed or opened like scissors and a fastening ring 12 for closing or opening the clamping part is used as the clip body as shown in FIG. 1A. As shown in FIG. 1B, the clamping part is closed by moving the fastening ring upward. A nylon loop 14 is attached to the clamping part of such a clip body. Then, as shown in FIG. 12, the end of the lesion site X being dissected in the digestive tract A is clamped by the clip 30, and then the free nylon loop 14 is driven into the inner wall of the digestive tract A while being held by a second clip 30' (FIG. 13). This completes the traction of the lesion site X. Note that in FIG. 12, the lesion site is depicted in a lifted state for convenience (the same applies to FIG. 9 and FIG. 10 below).

[0016] However, since the members used in this method are premised on being able to pass through the forceps port (treatment instrument insertion passage) of the endoscope, there is an inherent problem in that the size, shape, etc., of the members are limited.

[0017] Furthermore, because the above member has a structure in which the nylon loop 14 is attached to the clamping portion (clip wing portion) 11, even if it can pass through the forceps port of the endoscope, the following problem remains: That is, as shown in Fig. 13, when the lesion site X is clamped with the clip 30 and pulled via the nylon loop 14, when the lesion site X is viewed through the endoscope, the clip 30 hangs down between the endoscope and the lesion site, which may obstruct the field of view of the endoscope or interfere with the procedure. [Prior art documents] [Patent documents]

[0018] [Patent Document 1] JP 2017-60580 A [Non-patent literature]

[0019] [Non-Patent Document 1] Yoshiki Koike, Dai Hirasawa et al., "Efficacy of the Thread Clip Traction Method in Esophageal ESD: A Randomized Controlled Trial," Journal of the Japan Gastroenterological Endoscopy Society Vol. 57(1), Jan. 2015 [Non-Patent Document 2] Masaya Kamizato, Takashi Akai et al., "Effectiveness of the Clip Traction Method in Esophageal Endoscopic Submucosal Dissection," Chiba Medical Journal 87:237-243, 2011 [Non-Patent Document 3] Tsuneo Koyama, Yuichi Kikuchi, Shigeki Toritani et al., "Expanding the indications for gastric EMR: Technique innovations and outcomes aiming for en bloc resection based on size," Stomach and Intestines 2002;37:1155-61 [Non-Patent Document 4] Kaneka Corporation's endoscopic soft grasping forceps "ICHIGAN (registered trademark)" attached document (Medical device notification number: 27B1XO0O34000010 Medical device 25 Medical mirror General medical device 35524000) [Non-Patent Document 5] Takayuki Murase, Satoshi Maekawa, and Yoshiyoshi Yasuyasu "ESD using clips with threads: A simple clip method with threads using Zeoclip" https: / / www.jstage.jst.go.jp>article>gee>_pdf Summary of the Invention [Problem to be solved by the invention]

[0020] As described above, the internal and external traction methods have their own drawbacks.

[0021] On the other hand, it is true that internal traction and external traction each have their own unique advantages. For example, the method of performing traction from outside the body has the advantage of being able to adjust the traction force, while the method of performing traction from inside the body has the advantages of a) being able to freely set the traction direction, b) being able to perform traction at multiple sites, and c) not needing to remove or reinsert the endoscope.

[0022] For this reason, in order to utilize all of these advantages, there is a strong need for the development of technology that can achieve both internal and external traction with a single treatment tool, but the reality is that such technology has not yet been developed.

[0023] SUMMARY OF THE PRESENT DISCLOSURE OF THE PRESENT DISCLOSURE Accordingly, a primary object of the present invention is to provide a treatment tool capable of realizing both internal and external traction when performing treatment with an endoscope. [Means for solving the problem]

[0024] As a result of extensive research into the problems of the prior art, the present inventors have discovered that a traction device having a specific structure can achieve the above object, and have thus completed the present invention.

[0025] That is, the present invention relates to the following clip-type traction device. 1. An instrument for clamping and pulling at least a lesion site in a body under endoscopic guidance, (1) The device has (a) a clamping portion that can be opened, closed, or snapped open like scissors, and (b) a clip portion including a fastening means for opening and closing the clamping portion, (2) One or more thread-like members having a loop portion are connected to the tail portion of the clip portion on the opposite side to the clamping portion, (3) a) the connection between the tail and the thread-like member and / or b) the connection between the thread-like members can be released by opening the loop of the thread-like member. A clip-type traction device characterized by: 2. A clip-type traction device as described in paragraph 1 above, in which a filamentous member having a loop portion of sufficient length to at least traction a lesion site inside the body from outside the body is attached to the tail and / or the filamentous member connected to the tail. 3. A clip-type traction device according to claim 1 or 2, further comprising a sheath, and a part or the whole of the thread-like member is housed within the tube of the sheath. 4. The clip-type traction device according to claim 3, wherein the sheath is made of resin. Effect of the Invention

[0026] According to the present invention, it is possible to provide an instrument capable of realizing both internal and external traction when performing treatment using an endoscope.

[0027] In particular, in the clip-type traction device of the present invention, one or more filamentous members having loops are connected to the tail of the clip part on the opposite side of the clamping part, and a) the connection between the tail and the filamentous member and / or b) the connection between the filamentous members can be released by opening the loop of the filamentous member. In particular, the filamentous members are connected to each other by passing through each other's loops, and the connection of the opened filamentous members can be released by opening one of the loops. This makes it relatively easy to select and switch between traction from inside the body (internal traction) and traction from outside the body (external traction) through an endoscope. As a result, in the present invention, both internal traction and external traction can be performed with one instrument (treatment tool).

[0028] As described above, there are two types of traction methods for performing ESD safely and efficiently: external traction and internal traction, each of which has its own advantages and disadvantages. However, currently, dedicated treatment tools are used for external traction and internal traction, and it is not possible to select external traction and internal traction with a single treatment tool, or to change the traction method between them. In actual medical practice, for example, during the resection of diseased tissue by ESD, a situation may arise in which it is desired to change the traction method between the two due to the selection of both traction methods, adjustment of the traction force, change of the traction direction, etc., but it has been considered difficult to change easily up to now. In this respect, the clip-type traction device of the present invention allows relatively easy switching between internal traction and external traction depending on the situation, making it possible to perform treatment such as ESD more safely and quickly.

[0029] Furthermore, particularly in the case of traction from within the body, in the clip-type traction device of the present invention, a loop-shaped thread-like member is attached to the tail portion on the opposite side of the clamping portion of the clip portion. Therefore, unlike the above-mentioned Non-Patent Document 5 and the like, the peeling portion and the longitudinal direction of the device of the present invention are arranged in a substantially straight line, which effectively reduces the risk of obstructing the field of view of the endoscope or causing problems in operation. [Brief description of the drawings]

[0030] [Figure 1] FIG. 1 is a diagram showing the basic configuration of a clip forceps. [Diagram 2] FIG. 2 is a schematic diagram of the device of the present invention in which an internal traction filament member and an external traction filament member are connected. [Diagram 3] 13A and 13B are diagrams showing a state in which the thread-like members are released from each other. [Figure 4] 1A and 1B are diagrams showing specific examples of a loop portion in the device of the present invention. [Diagram 5] 11A and 11B are diagrams showing specific examples of a connected state of multiple thread-like members. [Figure 6] 13 shows an example of a connection state between the tail of the device of the present invention and a thread-like member. [Figure 7] FIG. 13 is a diagram showing a state in which a lesion site is being pulled by the instrument of the present invention via a filamentous member extending from the tip of an endoscope. [Figure 8] FIG. 8 is a diagram showing the state after the endoscope in FIG. 7 has been removed. [Figure 9] FIG. 13 is a view showing a state in which a lesion site is grasped with the instrument of the present invention and the filamentous member is freed. [Figure 10] FIG. 10 is a diagram showing the state before the free thread-like member in FIG. 9 is gripped by a clip. [Figure 11] FIG. 11 is a diagram showing the state in which the free thread-like member in FIG. 10 is fixed and pulled in the digestive tract. [Figure 12] FIG. 1 shows the state after a lesion has been grasped with a conventional clip with a nylon loop, prior to grasping and pulling on healthy mucosa with the clip. [Figure 13] FIG. 13 is a diagram showing the state in which the free thread-like member in FIG. 12 is fixed and pulled in the digestive tract. [Explanation of symbols]

[0031] 10 Clip part 11 Clamping part (wing part) 12 Fastening means (or fastening ring) 13 Tail 13a Tail space 14 Nylon Loop 15a, 15b, 15c, 15d Thread-like members 15L, 15L', 15aL, 15bL Loop section 20 Clip-type traction device (device of the present invention) 30,30' clip A Gastrointestinal tract X: Lesion or avulsion area Y Endoscope DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0032] The clip-type traction device of the present invention (the device of the present invention) is a device for clamping and traction at least a lesion site in a body under endoscopic guidance, (1) The device has (a) a clamping portion that can be opened, closed, or snapped open like scissors, and (b) a clip portion including a fastening means for opening and closing the clamping portion, (2) One or more thread-like members having a loop portion are connected to the tail portion of the clip portion on the opposite side to the clamping portion, (3) a) the connection between the tail and the thread-like member and / or (b) the connection between the thread-like members can be released by opening the loop of the thread-like member. It is characterized by:

[0033] In the present invention, "at least the lesion site" refers to the portion that is retracted and excised by the instrument of the present invention, and includes the case of only the lesion site, as well as the case of both the lesion site and the surrounding normal tissue. Hereinafter, the above "at least the lesion site" is also simply referred to as the "retraction site."

[0034] A. Configuration of the device of the present invention An outline of a configuration example of the device of the present invention is shown in Fig. 2. As shown in Fig. 2, the device of the present invention 20 has a clip part 10 including a clamping part 11 that can be opened and closed like scissors, and (b) a fastening means 12 for opening and closing the clamping part, and a thread-like member 15a having a loop part is attached to a tail part 13 on the opposite side of the clamping part of the clip part 10, and another thread-like member 15b having a loop part is connected to this thread-like member 15a. Note that, for convenience, in Fig. 2, the thread-like member is shown as a representative example of an internal traction thread-like member 15a and an external traction thread-like member 15b, but is not limited thereto, and a thread-like member other than these may be connected to the thread-like members 15a and 15b, or may be connected to the tail part 13.

[0035] The fastening means 12 may be of any shape, but may preferably be a ring-shaped member as shown in Fig. 2. Although not shown, the body of the clip passes through the ring of the ring-shaped member. Then, with the thread-shaped member 15a etc. pulled, the fastening ring as the fastening means 12 is slid toward the clip part 10, thereby closing the clamping part 11. This makes it possible to grip the tissue of an internal organ (such as the digestive tract mucosa).

[0036] The thread-like members 15a, 15b are connected to each other by passing through each other's loop portions, and it is possible to untie the connection between the opened thread-like members by opening one of the loop portions.

[0037] FIG. 3 shows an example of a form in which the thread-like members 15a and 15b are connected to each other (tails and the like are not shown). For example, as shown in FIG. 3A, the loop portion 15bL of the thread-like member 15b is opened by cutting the thread-like member 15b at point x, and as a result, the thread-like member 15b is pulled out from the thread-like member 15a in the direction a or b as shown in FIG. 3B, and the thread-like members 15a and 15b can be separated. That is, the two can be easily separated by the process of cutting one of the thread-like members (i.e., opening the loop portion) without using a special separating part. In this way, the "connection" in the present invention refers to a connection on the premise that the connection of the opened thread-like members can be released by opening one of the loop portions. It is preferable that the loop portion can be opened by cutting one place of the thread-like member.

[0038] In the present invention device 20 of Fig. 2, the thread-like member 15b has a length sufficient to pull the towing portion from outside the body, and functions as a traction member for external use. That is, the tissue inside the body can be pulled from outside the body (the oral cavity side or the anus side) via the thread-like member 15b. On the other hand, the thread-like member 15a can also be used as a traction member for internal use by taking advantage of its shortness. Therefore, for example, the towing portion of a lesion in the digestive tract can be pulled with the thread-like member 15a fixed to the digestive tract mucosa around the opposing position.

[0039] The clip 10 and thread-like members 15a, 15b may be stored in a sheath (tube) (inside the sheath) in a state in which the clip can be opened, closed, or closed by operating the distal end of the clip.

[0040] In FIG. 2, thread-like member 15a and thread-like member 15b are connected by passing through each other's loops, but this is not necessarily required. For example, each may be fixedly attached or connected to tail portion 13 of clip 10 separately and independently.

[0041] As shown in FIG. 1A, the clip portion 10 itself can be suitably used in which the clamping portion 11 is open before clamping, and the clamping ring 12 is moved upward to close the clamping portion 11 when clamping internal tissue. Therefore, as long as it has such a mechanism, there is no particular limitation, and a clip or the like used in a publicly known or commercially available endoscope can be used. Therefore, as commercially available clips, various clips such as clips for closing or blocking perforations or fistulas, clips used for stopping bleeding in the digestive tract, etc. can be applied. In addition, the material of the clip portion (including the clamping ring) is also not particularly limited, and examples thereof include metals (including alloys) such as stainless steel.

[0042] One or more thread-like members having a loop are attached to the tail portion 13 on the opposite side of the clamping portion of the clip portion. In FIG. 2, one thread-like member 15a is attached to the tail portion 13.

[0043] Each thread-like member has a loop portion (ring). As shown in FIG. 3, each thread-like member 15a has a loop portion 15aL. By having the loop portion, the thread-like member can be easily and securely grasped with a clip and fixed to any location inside the body by the clip. More specifically, by clipping any location inside the body with the wings of the clip open like scissors hooked on the loop portion, the detached portion including the lesion site and its surrounding area can be retracted.

[0044] The number and shape of the loop portions contained in one filamentous member are not particularly limited, and examples include a filamentous member consisting of one loop portion 15L like a rubber band as shown in Figure 4A, as well as a filamentous member in which multiple loop portions 15L, 15L' are integrally formed as shown in Figure 4B.

[0045] In addition, the number of traction members that are connected to each other in a state where they pass through the loop portions of the other thread-like member and that are in a state where the connection is released when at least one of the loop portions is opened is counted as the number of such loop portions.

[0046] In the device of the present invention, as shown in FIG. 5, two or more thread-like members may be connected in series or in parallel. "Series" refers to a state in which one loop portion is connected to another loop portion. "Parallel" refers to a state in which one loop portion is connected to two or more other loop portions. The connection form may be either series, parallel, or both. FIG. 5 shows various connection states of four thread-like members 15a, 15b, 15c, and 15d. These thread-like members may be for either internal or external traction.

[0047] In FIG. 5A, four thread-like members 15a, 15b, 15c, and 15d are connected in series. In FIG. 5B, four thread-like members 15a, 15b, and 15c are connected in series, and thread-like members 15c and 15d are connected in parallel. In FIG. 5C, four thread-like members 15a, 15c, and 15d are connected in series, and thread-like members 15b and 15c are connected in parallel. In particular, when connected in parallel, it is possible to change the traction from within the body to traction from another part of the body. That is, by cutting and opening the loop part of the thread-like member 15 used for traction from within the body, the other loop part of the thread-like member 15 becomes free while attached to the tail part of the clip. By grasping such a loop part with another clip and fixing it to the digestive tract wall of another part, the direction, strength, etc. of traction from the initial traction part from within the body to another traction part can be arbitrarily changed. This also makes it possible to switch, for example, from internal traction to external traction.

[0048] 2, the thread-like member 15a can be a member (internal traction member) that is mainly used to fix and traction any part inside the body. Therefore, the material is not limited as long as it has a strength that can withstand traction, and for example, synthetic fibers (polyamide, polyester, etc.), natural fibers (silk, etc.), and rubber (natural rubber, silicone rubber, etc.) that are used as sutures can be applied, and metal wires and the like can also be used.

[0049] The thread-like member 15a is connected to the tail portion 13 on the opposite side of the clamping portion of the clip portion 10. The tail portion 13 is preferably the end on the opposite side of the clamping portion of the clip portion 10. This allows the clip body 10 and the thread-like member 15a to be positioned in a substantially straight line when pulled, effectively reducing the risk that the clip portion itself will obstruct the practitioner's field of vision, etc.

[0050] It is preferable that the connection between the thread-like member 15a and the tail portion 13 of the clip portion 10 can be untied by opening the loop of the thread-like member 15a. That is, it is preferable that the thread-like member 15a is connected in a detachable state to the clip portion 10. This allows the thread-like member 15a to be easily removed by cutting and opening the loop when it is no longer needed. For example, FIG. 6 shows an enlarged image of part A in FIG. 2. As shown in FIG. 6, when the loop portion is formed by passing the thread-like member 15a through the space portion 13a formed in the tail portion 13 and closing the loop, the thread-like member can be pulled out by cutting one part of the loop portion and opening the loop. Other methods include a method of providing a hook portion on the thread-like member 15a and hooking the hook portion on the tail portion 13, and a method of temporarily fixing the thread-like member 15a to the tail portion 13 with an adhesive, a pressure-sensitive adhesive, or the like.

[0051] The size of the thread-like member 15a can be appropriately adjusted depending on whether it is for internal or external traction, the part to be traction, the size, etc. For example, when it is mainly used for internal traction, the length when it is straightened without opening the loop can be set within the range of about 0.5 to 5 cm, but is not limited thereto.

[0052] In addition to the thread-like member, the device of the present invention also has a thread-like member having a loop portion long enough to retract at least the lesion site in the digestive tract and the digestive tract mucosa from outside the body. This is connected to the tail portion and / or the thread-like member. In Fig. 2, such a thread-like member 15b is connected to the thread-like member 15a.

[0053] 2 is a member (external traction member) used for traction from outside the body (for example, outside the mouth). The material of the filamentous member for external traction is not limited as long as it has low toxicity to the living body and has strength sufficient to withstand traction, and may be, for example, synthetic fibers (polyamide, polyester, etc.), natural fibers (silk, etc.), and rubber (natural rubber, silicone rubber, etc.) used as sutures, as well as metal wires and the like.

[0054] In the present invention, it is preferable that thread-like member 15b is connected to thread-like member 15a as shown in Fig. 2. Thread-like member 15a and thread-like member 15b may not be connected to each other and may be attached to clip portion 10 separately and independently. The connection method may be appropriately selected depending on the shape of thread-like member 15b, etc.

[0055] The thread-like member 15b has a loop-like (ring-like) shape as a whole, but has a loop portion in part. Even if This allows the loop-shaped thread-like member 15b to be passed through the loop portion of the thread-like member 15a and connected in a chain-like manner passing through each other's loop portion. This allows the thread-like member to be easily pulled out by cutting the thread-like member and opening the loop portion when the thread-like member is not needed. When the thread-like member 15b is made into a loop, it may be connected like a chain in which two or more loops pass through each other's loops, but from the viewpoint of ease of the pulling operation as described above, it is preferable that it is composed of one loop. When connected, the thread-like member 15b can be connected in series and / or parallel in the same manner as the thread-like member shown in FIG. 5.

[0056] The length of the thread-like member 15b can be adjusted as appropriate depending on, for example, the height of the patient, the part to be pulled, etc., but is not limited as long as it is long enough to be pulled from outside the body. For example, if the part to be pulled is the stomach of an adult or its surroundings, the length of the thread-like member when straightened without opening the loop can be set as appropriate within the range of about 80 to 230 cm.

[0057] The inventive device can generally be used with the thread-like members partially or entirely housed within the sheath tube. That is, thread-like members 15a and 15b are usually made of a soft thread-like material, and by housing them in a sheath (tubular member) having a certain rigidity, the sheath can be easily loaded into the endoscope body. In this case, the clip portion of the inventive device may be partially or entirely protruding from the sheath, or may be completely housed in the sheath with the clip portion closed.

[0058] As the sheath, one generally used for endoscopes can be used. Such a sheath has a certain degree of rigidity and flexibility, and the rigidity allows the sheath to be loaded into the endoscope body, while the flexibility allows the sheath to follow the movement of the endoscope. The material is not particularly limited, and examples of the sheath include sheaths made of synthetic resins such as polyester, polyvinyl chloride, and polyurethane. The inner diameter of the sheath can also be appropriately selected depending on, for example, the type of filamentous member used, and can be set to, for example, about 0.5 to 5 mm. Commercially available products can also be used as these sheaths.

[0059] B. Usage of the device of the present invention The instrument of the present invention is used when a lesion site in the body is pulled under an endoscope, and to that extent, the type of endoscope is not particularly limited. For example, it can be applied to any of treatments using upper gastrointestinal endoscopes, small intestinal endoscopes, large intestinal endoscopes, bronchoscopes, cystoscopes, thoracoscopes, laparoscopes, etc. Therefore, the organs in the body to which it is applied are not particularly limited, and examples include the digestive tract such as the stomach, esophagus, large intestine, small intestine, duodenum, and bile duct, as well as the oral cavity, nasal cavity, pharynx, bronchi, ureters, and intraperitoneal organs. Among these, the instrument of the present invention can be suitably used for dissection and pulling of a lesion site of mucosal tissue in an internal organ (particularly the digestive tract). Therefore, it can be suitably used for, for example, endoscopic submucosal dissection (ESD).

[0060] In the following, a case where a lesion site in the stomach is resected using the device of the present invention will be described as a representative example with reference to the drawings.

[0061] First, a clip-type traction device as shown in FIG. 2 is prepared as the device of the present invention, and thread-like members 15a and 15b are housed in a synthetic resin sheath, and the clip portion 10 is exposed from the tip of the sheath.

[0062] In this state, the endoscope main body Y is inserted into the patient's mouth, and the lesion and its surrounding area are dissected under the guidance of the endoscope. Next, as shown in Fig. 7, the instrument 20 of the present invention is released from the endoscope Y toward the dissected portion X during or after dissection is completed, and the instrument 20 of the present invention clamps the dissected portion X with the clamping portion 11, and passes through the treatment tool insertion passage of the endoscope Y and is connected to the hand operation portion at the entrance of the endoscope treatment tool insertion passage outside the body.

[0063] When performing internal traction using short thread-like member 15a, long thread-like member 15b is not necessary, so it is sufficient to cut the sheath and the loop of the thread-like member to separate thread-like member 15b from thread-like member 15a, and then remove only thread-like member 15b from the body.

[0064] Thereafter, as shown in Fig. 10, another clip 30 is released from the treatment tool insertion passage (forceps insertion passage) (not shown) of the endoscope Y in an open state while gripping the thread-like member 15a toward the inner wall of the digestive tract A. When this clip 30 grips the inner wall of the digestive tract A, it is released from the clipping launcher. As a result, as shown in Fig. 11, the clip 30 hooks the thread-like member 15a of the inventive instrument 20 connected to the inventive instrument 20 by gripping the dissected portion (pulling portion), and in this state, grips the inner wall of the digestive tract A. As a result, the dissected portion X is pulled via the clip 30 anchored to the wall surface facing the dissected portion X and the thread-like member 15a.

[0065] On the other hand, when pulling from outside the body with thread-like member 15b, the same operation as above is performed up to the state shown in Fig. 7. As a result, detached portion X, thread-like member 15a, and thread-like member 15b are connected to each other. One end of thread-like member 15b is connected to thread-like member 15a, and the other end extends to the outside of the body.

[0066] Thereafter, the endoscope and the sheath are pulled out of the body, and the endoscope and the sheath can be pulled out of the body in the state shown in FIG. 8. When pulling out the endoscope and the sheath, for example, the thread-like member 15b can be cut outside the body, and the endoscope and the sheath can be removed from there. In this process, the order in which the endoscope and the sheath are removed can be any order, and the thread-like member 15b can be cut after the endoscope and the sheath are removed. The cut portion of the thread-like member 15b is the end, and the end can be manually grasped outside the body to perform the pulling operation. Alternatively, a loop auxiliary member connected to the end of the thread-like member 15b outside the body can be provided in advance, and the loop auxiliary member can be cut to remove the endoscope and the sheath from there. In this case, it is not necessary to cut the thread-like member 15b. The end of the thread-like member 15b protruding outside the body can be pulled by the practitioner's fingers. This allows, for example, the pulling force, the pulling amount, and the like to be finely adjusted.

[0067] As described above, the device of the present invention allows selection of both traction from inside the body and traction from outside the body according to the situation, and further allows switching from traction from outside the body to traction from inside the body during treatment, and switching from traction from inside the body to traction from outside the body during treatment. To switch from traction from outside the body to traction from inside the body, the thread-like member 15b is cut outside or inside the body, so that the end of the thread-like member 15a becomes free while being connected and fixed to the lesion site X by the clip clamping part 11, and the thread-like member 15a is further fixed to the inner wall of the digestive tract A by another clip. In this case, if multiple loop thread-like members are connected as shown in FIG. 5, by opening the thread-like member 15b used for traction from outside the body, the thread-like member 15b used for traction from outside the body can be removed, and the freed loop thread-like member for internal traction can be used easily for traction from inside the body.

[0068] On the other hand, to switch from traction inside the body to traction outside the body, it is possible to use another instrument of the present invention. That is, after the thread-like member 15a is detached from the clip that fixed it to the digestive tract wall A and set in a free state, the loop of the thread-like member 15a can be pulled from outside the body in a similar manner to the extracorporeal traction using the instrument of the present invention. In this case, before removing the thread-like member 15a from the clip that fixed it to the digestive tract wall A, a connected state between the thread-like member 15a and the thread-like member for extracorporeal traction may first be established, and then the thread-like member 15a may be removed from the clip that fixed it to the digestive tract wall A.

[0069] After the detached portion X is pulled by the inventive device, the detached portion can be completely cut off from the body by a normal procedure, and the resection of the lesion can be completed. After that, the inventive device that is pulling the detached portion X can be removed from the body together with the inventive device. The inventive device can also be removed from the detached portion, and the inventive device can be collected separately from the detached portion, and the detached portion can be removed alone.

[0070] In this way, by pulling the detached portion with the instrument of the present invention, it becomes possible to easily view the area to be resected, and the position and course of blood vessels can be more easily grasped. This makes it possible to more reliably avoid bleeding or perforation, and facilitates the resection operation. As a result, the time required for resection can be shortened, allowing for safe and reliable resection of early-stage gastrointestinal tumors, etc., and also reduces the burden on the patient. EXAMPLES

[0071] The features of the present invention will be described in more detail below with reference to examples. However, the scope of the present invention is not limited to the examples. In the examples, the traction method from inside the body, the traction method from outside the body, switching from the traction method from outside the body to the traction method from inside the body, and switching from the traction method from outside the body to the traction method from inside the body will be described in this order.

[0072] Example 1 (Traction from within the body) An example of a surgical procedure in which early stage gastric cancer is resected by ESD using the instrument 20 of the present invention as shown in FIG. 2 will be described below. The endoscope is orally inserted into the digestive tract, and reaches the affected area of ​​the stomach or its vicinity (target area for resection), and the extent of resection is determined. Then, the mucosal layer, which is the surface layer of the digestive tract wall (stomach wall), is incised so that the area can be completely removed, exposing the submucosal layer below the detached portion X. Then, the inventive device 20 as shown in Fig. 2 is loaded into the tube of the synthetic resin sheath. Next, with the tip of the endoscope Y still positioned at the lesion site, the sheath equipped with the traction members is inserted into the endoscope, and the inventive instrument 20 is guided to the vicinity of the dissected portion X through the treatment tool insertion passage of the endoscope. The clip portion 10 of the inventive instrument 20 is then brought out to clamp the end of the dissected portion X. At this time, the inventive instrument 20 is connected to the lesion site X through the endoscope insertion passage. After that, the sheath is cut or removed, and the thread-like member 15b is cut, whereby the clip portion and its tail thread-like member 15a are detached from the endoscope Y. This state is shown in Figure 9. Figure 9 shows the state after the thread-like member 15b has been removed. 10, another clip 30 guided through the endoscopic treatment tool passage is used to grasp the loop portion of the filamentous member 15a of the inventive device, and while grasping the loop portion, the clip is driven into the surrounding digestive tract wall (for example, normal tissue portion of the stomach wall). As a result, as shown in Figure 11, when tension is applied to the dissected portion X in the direction in which it is lifted by the inventive instrument 20 (the direction in which the dissected portion is turned up into the digestive tract lumen), the submucosal layer is dissected without damaging the underlying muscularis propria. The dissected submucosal layer is turned up in order because a traction force is applied to it. By repeating this series of operations, the lesion can be completely removed. By the above-mentioned process, the lesion site to be pulled can be pulled up in the appropriate direction with an appropriate traction force, and the resection site can be exposed, which makes it possible to directly view the resection site and the blood vessels present in the resection site, and enables a safe resection. Even if bleeding or perforation occurs, the lesion site can be prevented from covering the bleeding site or perforation site by traction, so that operations for stopping the bleeding and closing the perforation site can be easily performed. Even if the inventive instrument 20 obstructs the endoscopic field of view or the resection operation, the obstruction can be easily avoided by the following operations. For example, the traction member can be removed by guiding a commercially available scissors forceps to the lesion site through the treatment tool insertion passage in the endoscope. Depending on the situation, it is also possible to use an electric scalpel and pass electricity through it to cut and remove the traction member.

[0073] Example 2 (External Traction) As in Example 1, the inventive instrument 20 is inserted through the endoscope and the endoscopic treatment tool insertion passage and introduced into the digestive tract, and the end of the lesion site X is clamped by the clip portion 10 of the inventive instrument 20 as shown in Fig. 7. By removing the sheath and endoscope at this stage, the end of the lesion site X can be pulled from outside the body by the clip portion 10 and the thread-like members 15a and 15b. This state is shown in Fig. 8. Next, the endoscope is reinserted orally. The submucosal layer that has been exposed and visualized by traction can be dissected further with the endoscope, making it possible to safely and efficiently remove the lesion X.

[0074] Example 3 (conversion from external traction to internal traction) After performing traction from outside the body as in Example 2 (FIG. 8), one part of the thread-like member 15b is cut to open the loop, and the thread-like member 15b is removed. As a result, the end of the thread-like member 15a becomes free while the thread-like member 15a is clamped by the clip part 10 of the device 20 of the present invention at the end of the lesion site X (FIG. 9). In this state, the other clip is used to fix the end of the thread-like member 15a to the digestive tract wall A in the same manner as in Example 1, thereby enabling traction from within the body (FIGS. 10-11). By continuing the submucosal dissection in this state, it becomes possible to safely and efficiently excise the diseased tissue. In another embodiment, after performing traction from outside the body as in Example 2 (FIG. 8), without opening one loop of thread-like member 15b, another clip is used to fix the end of thread-like member 15a to the digestive tract wall A, and then one part of thread-like member 15b is cut to open the loop, and thread-like member 15b is removed. In this way, thread-like member 15b is in a tensioned state when it is cut, making it easy to grasp and cut thread-like member 15b.

[0075] Example 4 (Conversion from internal to external traction) In a state where traction is being performed from within the body in the same manner as in Example 1 (FIG. 11), the clip 30 clamping the digestive tract wall A is removed from the digestive tract wall A, or the thread-like member 15a held by the clip 30 is cut, opened, and removed, so that the thread-like member 15a becomes free while attached to the end of the lesion site X via the attached clip part 10. Thereafter, the end of the free thread-like member 15a is clamped by the second present invention instrument 20' through the treatment tool insertion passage of the endoscope. As described above, when the loop is opened by cutting the thread-like member 15a, the cut end of the thread-like member 15a may be clamped. Alternatively, if a spare thread-like member 15c (not shown) is connected in advance to the tail of the clip part 10, it becomes easier to hold and pull the thread-like member 15c by grasping the loop part 15cL of the thread-like member 15c. Next, the endoscope and sheath can be withdrawn in the same manner as in Example 2, allowing for switching to traction from outside the body. The endoscope is then reinserted, and while performing traction from outside the body, submucosal dissection can be continued, allowing for safe and efficient resection. In another embodiment, after performing traction from within the body as in Example 1 (FIG. 11), the thread-like member 15a is not set free, and the thread-like member 15a or the tail 13 to which it is connected is grasped by the second inventive device 20'. In this way, the connection of "thread-like member 15a of the first inventive device 20 or the tail 13 to which it is connected" - "clip 30' of the second inventive device 20'" - "thread-like member 15a' of the second inventive device 20'" - "thread-like member 15b' of the second inventive device 20'" is formed, and then 15a of the first inventive device is cut at an appropriate location to open the loop, thereby enabling extracorporeal traction.

Claims

1. An instrument for clamping and pulling at least a lesion site in a body under endoscopic guidance, (1) The device has (a) a clamping portion that can be opened, closed, or snapped open like scissors, and (b) a clip portion that includes a fastening means for opening and closing the clamping portion, (2) One or more thread-like members having a loop portion are connected to the tail portion of the clip portion on the opposite side to the clamping portion, (3) a) the connection between the tail and the thread-like member and / or b) the connection between the thread-like members is In the connection of the above-mentioned a), a loop portion is formed by passing a filamentous member through a space formed in the tail portion and closing the space, In the connection of the above b), each filament passes through the loop of the other filament, (4) The connection can be released by cutting one part of the loop of the thread-like member to open it. A clip-type traction device characterized by:

2. 2. The clip-type traction device according to claim 1, wherein a filamentous member having a loop portion having a length sufficient to traction at least a lesion site inside the body from outside the body is attached to the tail and / or the filamentous member connected to the tail.

3. 3. The clip-type traction device according to claim 1, further comprising a sheath, and a part or all of the thread-like member is housed within a tube of the sheath.

4. 4. The clip-type traction device according to claim 3, wherein the sheath is made of resin.

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