JP7790243B2 - Endoscopic treatment tools - Google Patents

Description

The present invention relates to an endoscopic treatment tool, particularly to an endoscopic treatment tool suitable for lifting internal body tissue under an endoscope.

When a tumor develops in the stomach or other digestive tract, rigid laparoscopes have traditionally been used to perform minimally invasive surgery that leaves smaller scars on the body surface than open surgery. However, in recent years, medical technology has been proposed that enables even less invasive surgery by using flexible endoscopes with bendable insertion sections that can be inserted orally. Hereinafter, flexible endoscopes will also be simply referred to as endoscopes.

For example, in recent years, laparoscopic and endoscopic combined surgery (LECS), which uses both a laparoscope and an endoscope, has been used to remove tumors through open surgery or laparoscopic surgery, while advanced medical technologies such as endoscopic full-thickness resection (EFTR), which uses only an endoscope, have been proposed to make the procedure even less invasive.

EFTR uses an endoscope to transorally resect and retrieve tumors, enabling pathological diagnosis. If the tumor has invaded the muscularis propria of the gastrointestinal tissue, an electric scalpel inserted through the forceps port of the endoscope is used to resect the mucosa around the lesion, after which the tumor's attachment to the muscularis is exposed. The muscularis is then incised and a full-thickness resection of the gastrointestinal tissue is performed to remove the lesion.

In addition, when performing EFTR, a surgical procedure has been proposed in which the gastrointestinal tissue containing the lesion is lifted up inside the lumen under endoscopic guidance, the gastrointestinal tissue is inverted at its base, and then the gastrointestinal tissue containing the lesion is excised. This procedure allows the lesion to be excised without disrupting communication between the inside and outside of the gastrointestinal tract, which has the advantage of preventing leakage of gastrointestinal contents such as digestive fluids into the peritoneum and reducing the postoperative risk of peritonitis.

For example, Patent Document 1 discloses an endoscopic treatment tool suitable for this procedure: a suturing device that includes a front arm with a storage space, a rear arm with a pair of needle-shaped members, arm movement means for moving the arms closer together or apart, and when the arms move closer together, the needle-shaped members engage with an engaging member with a suture thread stored in the storage space, thereby suturing the tissue located between the arms. This suturing device makes it possible to effectively suture the base of digestive tract tissue that has been lifted into the lumen.

Patent Document 1 also discloses a method for suspending gastrointestinal tissue containing a lesion inside the lumen in advance, in which the gastrointestinal tissue containing the lesion and the opposing gastrointestinal tissue are connected with a suture. Patent Document 1 also discloses that a separate suturing device described in Patent Document 2 can be used to connect the gastrointestinal tissue containing the lesion to the opposing gastrointestinal tissue.

International Publication No. 2017/164359 Patent No. 5294181

However, the technique of using a suturing device to connect opposing pieces of gastrointestinal tissue with sutures and thereby lifting the gastrointestinal tissue into the lumen has the problem that it requires a relatively difficult procedure to connect the gastrointestinal tissue. In addition, it requires the use of separate suturing instruments attached to the endoscope for both lifting the gastrointestinal tissue and suturing its base, which necessitates the removal and reinsertion of the endoscope between lifting the tissue and suturing its base, resulting in a cumbersome process.

The present invention aims to resolve these unresolved issues and provide an endoscopic treatment tool that can lift internal tissue with relatively simple operation.

(1) To achieve the above-mentioned objective, the endoscopic treatment tool of the present invention comprises a tubular sheath, a control wire inserted into the sheath, a tool positioned at the distal end of the sheath, a handle body connected to the proximal end of the sheath, and an operating member operably connected to the tool via the control wire and sliding the control wire relative to the handle body in at least the axial direction of the sheath, wherein the tool has a plurality of claw members that are movable between a stored position stored at the distal end of the sheath and a use position protruding outward from the distal end of the sheath, each of the plurality of claw members having a needle shape capable of puncturing internal tissue, and at least one of the plurality of claw members having an uneven shape.

With this configuration, the present invention allows the multiple claw members of the tool, extending axially through the sheath, to puncture internal tissue at a usage position protruding from the tip of the sheath. Furthermore, at least one of the multiple claw members has a concave-convex shape, which prevents the tool from slipping out once punctured into the internal tissue, making it possible to lift and hold the internal tissue. Furthermore, since the present invention allows for the endoscopic treatment tool to be easily configured to pass through the endoscope's treatment tool passage, an endoscope equipped with a suturing device for suturing the base of the lifted internal tissue can be used. By inserting the endoscopic treatment tool through the treatment tool passage, it is possible to lift the internal tissue and suture its base without removing and reinserting the endoscope, simplifying operation.

(2) In a preferred embodiment of the present invention, each of the multiple claw members can be configured to have an uneven shape. This further strengthens the tool's ability to prevent slipping out, allowing the tool to more fully exert its lifting force on internal tissue and its ability to maintain the lifted state.

(3) In a preferred embodiment of the present invention, the sheath can be configured to include a flexible tube that is slidably inserted into the endoscope. This allows the endoscope and the sheath that holds the tool located at its distal end to be freely displaced relative to each other in the axial direction and rotational direction around the axis, allowing the tool to be manipulated together with the sheath in the puncture direction and/or the retraction direction relative to the internal tissue, enabling reliable manipulation and support of the tool.

(4) In a preferred embodiment of the present invention, the tool can be configured to displace in the axial direction of the sheath in response to axial operation input of the operating member relative to the handle body, while rotating about the axis in response to rotational operation input from the operating member or the proximal end of the handle body. In this case, the amount of protrusion of the tool from the sheath tip can be adjusted, the tool can be operated in the puncture direction relative to body tissue independently of the sheath, and the tool can be rotated in the retraction direction together with the sheath or independently of the sheath, making it easy to adjust the position of the tool in the axial and rotational directions.

(5) In a preferred embodiment of the present invention, the handle body may be engaged with the operating member so as to be displaceable axially relative to the operating member, while restricting relative rotation about the axis. In this case, the handle body allows the operating member of the tool and the handle body connected to the sheath to be displaced axially relative to each other, making it possible to operate the tool in the puncture direction relative to the internal tissue independently of the sheath. On the other hand, the relative rotation about the axis of the operating member with respect to the handle body is restricted by the handle body, so that the tool can be rotated together with the sheath by rotating the operating member about the axis, thereby facilitating operation.

(6) In a preferred embodiment of the present invention, a displacement restriction mechanism can be provided that can restrict axial displacement of the operating member relative to the handle body at a position where the multiple claw members protrude a predetermined amount from the tip of the sheath. In this way, when the axial displacement of the operating member relative to the handle body is restricted by the displacement restriction mechanism, the amount of protrusion of the multiple claw members of the tool from the tip of the sheath is fixed, and operation can be facilitated by setting the amount of protrusion appropriate for puncturing, lifting, and wrapping body tissue.

(7) In a preferred embodiment of the present invention, a guide member that is slidable on the inner surface of the distal end side of the sheath may be integrally provided on the proximal end side of the multiple claw members of the tool. In this way, the guide member is slidably held on the inner surface of the distal end side of the sheath, allowing the multiple claw members of the tool to be stored in or protrude from the sheath in a suitable position.

(8) In a preferred embodiment of the present invention, the guide member can be configured to be arranged around the multiple claw members, spaced a predetermined distance from the distal ends of the multiple claw members toward the proximal end, and fixed to at least one of the multiple claw members. In this way, the guide member, which is spaced a predetermined distance from the tip of the tool, is fixed to at least one of the multiple claw members, and can be used as a stopper during puncture.

(9) In a preferred embodiment of the present invention, the multiple claw members are strip-shaped and face each other in the radial direction of the sheath, and at least one of the multiple claw members corresponding to one side in the axial direction may have a notch with the concave/convex shape formed on one side in the plate width direction, and a hook-shaped portion may be formed adjacent to the notch. In this way, the bending rigidity of the multiple claw members is increased in the plate width direction, which is the direction in which the internal tissue engages with the hook-shaped portions of the multiple claw members and the direction in which the internal tissue is wrapped around, and the lifting force of the internal tissue and the force with which it can be maintained in a lifted state can be sufficiently increased.

(10) The multiple claw members may have a smaller diameter toward the tip of the at least one claw member relative to the uneven portion of the at least one claw member. This makes it easier for the multiple claw members to puncture body tissue and makes it less likely for them to come loose after puncturing.

The present invention provides an endoscopic treatment tool that can perform a procedure in which internal tissue in the digestive tract is lifted and its base is sutured using a suturing device or the like through relatively easy endoscopic manipulation, and that can fully exert its lifting force on the internal tissue and its ability to maintain the lifted state.

1 is a schematic perspective view of a main portion of an endoscopic treatment tool according to an embodiment of the present invention. FIG. 2(A) is an explanatory diagram of the use state of an endoscopic treatment instrument according to one embodiment of the present invention, at the stage of inserting the instrument into a treatment instrument passage of an endoscope equipped with a suturing device and puncturing tissue, and FIG. 2(B) is an explanatory diagram of the use state of the instrument, at the stage of holding tissue in a lifted state. Figure 3(A) is an explanatory diagram linking a side view of the essential parts showing the operating direction of an endoscopic treatment tool according to one embodiment of the present invention in the stage of puncturing the tissue of the digestive tract with a diagram of the state of the surgical field under the endoscope at that stage; Figure 3(B) is an explanatory diagram linking a side view of the essential parts showing the operating direction of an endoscopic treatment tool according to one embodiment of the present invention in the stage of puncturing the tissue of the digestive tract and then rolling it up with a diagram of the state of the surgical field under the endoscope at that stage; and Figure 3(C) is an explanatory diagram linking a side view of the essential parts showing the operating direction of an endoscopic treatment tool according to one embodiment of the present invention in the stage of puncturing the tissue of the digestive tract and then rolling it up with a diagram of the state of the surgical field under the endoscope at that stage. 4(A) is a view in the direction of the arrow IVA in FIG. 1 showing one side of a tool (a main part of the treatment tool) when in use in an endoscopic treatment tool according to one embodiment of the present invention, FIG. 4(B) is a view in the direction of the arrow IVB in FIG. 1 with the multiple claw members shown in FIG. 4(A) facing forward, and FIG. 4(C) is a view in the direction of the arrow IVC in FIG. 1 showing the other side of the tool having the multiple claw members shown in FIG. 4(B). Figure 5(A) is an explanatory diagram of the operation at the stage where the suturing device attached to the endoscope is positioned near the suturing position on one side of the tissue in a suspended state in the circumferential direction inside the lumen, Figure 5(B) is an explanatory diagram of the operation at the stage where the needle member of the suturing device shown in Figure 5(A) is advanced while puncturing the tissue in a suspended state and fitted into the engaging member on the rear side, and Figure 5(C) is an explanatory diagram of the operation at the stage where the needle member of the suturing device shown in Figure 5(B) is retracted to remove it from the tissue and pull out the suture together with the engaging member. This is an explanatory diagram of the state as viewed from the tip side of the stage where a suturing device attached to an endoscope is placed near a predetermined suturing position on lifted tissue and suturing is performed. The suturing device shown in solid lines on the left side of the figure illustrates an example of a state of use corresponding to the leftmost suturing position of three adjacent suturing positions on the left side of the figure, and the suturing device shown in virtual lines on the right side of the figure illustrates an example of a state of use corresponding to the center leftmost suturing position of the three suturing positions. 10A and 10B are explanatory views of an example of a stage in which a suture is ligated by a suture ligating device inserted into a treatment tool passage of an endoscope. Figure 8(A) is an explanatory diagram of an example of a stage in which tissue above the sutured site is incised with an incision treatment instrument inserted into another treatment instrument passage of the endoscope, and Figure 8(B) is an explanatory diagram of an example of a stage in which tissue above the sutured site is incised with the incision treatment instrument shown in Figure 8(A) and then the tissue is retrieved with a grasping treatment instrument inserted into the treatment instrument passage of the endoscope. 9(A) is a top view of the essential parts showing a deformed form in which the tip sides of multiple claw members protruding from the tip of a sheath in an endoscopic treatment tool according to one embodiment of the present invention are expanded into a free shape, and FIG. 9(B) is a top view of the essential parts showing a state in which the expansion width of the multiple claw members is limited by the inner edge of the sheath tip when the tip portions of the multiple claw members shown in FIG. 9(A) are stored.

The following describes an embodiment of the present invention with reference to the drawings.

(One embodiment)
1 to 4 show an endoscopic treatment tool according to one embodiment of the present invention, and FIGS. 5 to 8 show an example of treatment performed after lifting internal body tissue with the endoscopic treatment tool.

First, we will explain the overall configuration of the endoscopic treatment tool of this embodiment.

The endoscopic treatment tool 1 of this embodiment shown in Figure 1 is used, for example, in non-penetrating endoscopic full-thickness resection (NFTR), also known as non-exposed EFTR. As shown in Figure 2, it is inserted through a flexible endoscope 2 and into the digestive tract DT, where it lifts up diseased tissue PP in the digestive tract DT toward the inside of the lumen and maintains that lifted state.

As shown in Figures 1 to 4, the endoscopic treatment tool 1 comprises a flexible, tubular sheath 11 that can be inserted into the treatment tool passage 2b of the endoscope 2, a lifting tool 12 located at the distal end 11a of the sheath 11, an operating wire 13 such as an operating/driving wire inserted into the sheath 11, an operating member 14 located at the proximal end 11d of the sheath 11 and operably connected to the lifting tool 12 via the operating wire 13, and a handle body 15 that is connected to the proximal end 11d of the sheath 11 and supports the operating member 14 so that it can be displaced axially relative to the proximal end 11d. Note that Figure 1 shows only the distal end of the endoscopic treatment tool 1 in an enlarged view, with the remaining portions being reduced for a simplified illustration.

The detailed structure of the endoscope 2 is not shown, but it has an operating section outside the body and an insertion section that is inserted into the body, with the tip of the insertion section being able to be freely bent by operating the proximal section. The tip section 2a of the endoscope 2 is also equipped with, for example, a light guide with an illumination lens that illuminates the inside of the lumen, a CCD camera with an objective lens, a nozzle that can supply fluids such as water or air into the lumen, and a distal opening of the treatment tool passage 2b, which is an internal cavity provided in the endoscope 2 for inserting endoscopic treatment tools.

A suturing device 3 is attached to the distal end 2a of the endoscope 2. The suturing device 3 has a fitting tubular portion 3a for attaching the endoscope and is integrally connected to an outer cover 3b. The distal end 2a of the endoscope 2 is inserted into the fitting tubular portion 3a of the suturing device 3 and is fixed in place. The endoscope 2 with the suturing device 3 attached is then orally inserted into the digestive tract DT from the distal end 2a side.

As shown in Figures 2, 5, and 6, the suturing device 3 has a front arm 31 with stepped hole-shaped suture needle storage spaces 31a, 31b, a rear arm 32 with suturing needle members 32a, 32b, and an arm movement mechanism 33 that moves the arms 31, 32 closer to and farther apart.

In the illustrated example of the suturing device 3, when the front arm 31 and rear arm 32, which are positioned so as to sandwich the diseased tissue PP in the digestive tract DT, are brought relatively close together, the needle members 32a, 32b of the rear arm 32 penetrate the suture target site ST1 of the tissue PP and are then pushed into the engaging members 35a, 35b, which are elastic rings with suture thread 34 attached, which have been previously housed within the housing spaces 31a, 31b of the front arm 31, and the engaging members 35a, 35b are held in the constricted portions 32c, 32d of the needle members 32a, 32b.

Furthermore, when the front arm 31 and the rear arm 32 are moved away from each other, the ends 34a, 34b of the suture 34 connected to the engaging members 35a, 35b are pulled out together with the engaging members 35a, 35b in the direction of penetrating the tissue of the suture target area ST1 as the needle members 32a, 32b are retracted, and the suture target area ST1 can be sutured simply by ligating the ends 34a, 34b of the suture 34.

The endoscopic treatment tool 1 is then pulled out and removed from the treatment tool passage 2b of the endoscope 2, and as shown in Figure 7, a suture ligation device 82 with a connecting hook 82a to which a suture ligation tool 81 is attached is inserted into the treatment tool passage 2b of the endoscope 2. These devices are then used to tighten and secure in a tangled state the ends 34a, 34b of the suture 34 that have passed through the tissue at the suture target site ST1 with the suturing device 3, i.e., ligate them, thereby suturing the suture target site ST1. The suture ligation tool 81 and suture ligation device 82 are similar to the suture ligation tool and ligation device described, for example, in JP 2020-163011 A. Once ligation of the suture 34 is complete, the suture ligating device 82 is removed from the treatment tool passage 2b of the endoscope 2, and instead a suture cutting tool capable of cutting the suture 34, such as an endoscopic electric scalpel, is inserted into the treatment tool passage 2b of the endoscope 2. This cuts the suture 34 located between the suture device 3 and the suture ligating tool 81, allowing the suture device 3 to be separated from the suture.

By repeating the above-described procedure, from suturing to cutting the suture thread, as many times as necessary while changing the suture position, the base of the tissue PP can be sutured together to create a liquid-tight seal. When suturing three suture target areas ST1, ST2, and ST3 as shown in Figure 6, the suture position can be changed by changing the positions and orientations of the endoscope 2 and the front arm 31 and rear arm 32 of the suturing device 3, or by operating the suturing device 3, the suture ligature tool 81, and the suture ligature device 82, as shown in Figures 2 and 6. The detailed structure of the arm movement mechanism 33 of the suturing device 3 is the same as that described in Patent Document 1.

The area to be sutured (for example, positions ST1 to ST3 shown in Figure 6) is located in advance by endoscopic examination, and when the tissue PP containing the marked lesion is lifted into the lumen of the digestive tract DT with the endoscopic treatment tool 1, it is set so that it is located proximal to the markings.

Furthermore, after suturing and ligation of the multiple suture target regions are completed, as shown in FIG. 8(A), a cutting treatment instrument 71, such as an endoscopic electric scalpel, inserted through the treatment instrument passage 2b of the endoscope 2 is used to incise the base of the tissue PP above the suture target regions ST1 to ST3, thereby separating the tissue PP from the digestive tract DT. The cutting treatment instrument 71 is then pulled out and removed from the treatment instrument passage 2b of the endoscope 2, and as shown in FIG. 8(B), the separated tissue PP is grasped with a retrieval treatment instrument 72, such as endoscopic grasping forceps, inserted through the treatment instrument passage 2b of the endoscope 2. The retrieval treatment instrument 72 is then pulled out of the body via the treatment instrument passage 2b of the endoscope 2, or together with the endoscope 2 while still inserted through the treatment instrument passage 2b, allowing the tissue PP to be removed and retrieved from the body.

Next, the configuration of the endoscopic treatment tool 1 of this embodiment will be described.

The sheath 11 of the endoscopic treatment tool 1 includes, as its main component, a flexible tube 11c that is slidably inserted into the endoscope 2, and a roughly annular mouthpiece member 11b with a chamfered outer and/or inner peripheral edge at the tip is attached to the tip of the flexible tube 11c.

The flexible tube 11c of the sheath 11 may be a tube made of resin or the like, but in this embodiment it is a coil tube made of metal such as stainless steel, for example, a flat wire coil tube made by spirally winding a strip of metal material, or a round wire coil tube.

The endoscopic treatment tool 1 is designed so that the lifting tool 12 is retracted and stored within the sheath 11 so that it is not exposed, and the relative axial displacement of the two is restricted before it is inserted into the endoscope 2 from the distal end 11a of the sheath 11. Therefore, the flexibility and bending rigidity of the flexible tube 11c are optimally set to achieve both flexibility sufficient to follow the free deformation of the distal end 2a of the endoscope 2 inserted orally into the digestive tract DT, and the required bending rigidity when using the lifting tool 12 to lift and hold the tissue PP (described below).

The lifting tool 12 is connected to the distal end 13a of the operating wire 13 located on the distal end of the endoscope 2 via a connecting member 24, and the proximal end 13b of the operating wire 13 located on the operating section side of the endoscope 2 (not shown) is fixed to a metal sliding member (not shown) that is slidably disposed within the substantially cylindrical handle body 15. The connecting member 24 may be connected in any manner that constrains the lifting tool 12 and the distal end 13a of the operating wire 13 substantially integrally in the axial direction. This connection is not limited to welding or mechanical connection, and may also be a rubber-elastic connection.

The operating member 14 has finger holes 14a and 14b on either side of a central cylindrical portion 14c through which the handle body 15 slidably passes. The operating member 14 is provided with a screw-type movement restriction member 16, which serves as a displacement restriction mechanism, that radially passes through a portion of the central cylindrical portion 14c.

As shown in Figure 1, the operating member 14 slidably engages with a stepped elongated hole 15b formed in the handle body 15 at an internal convex portion (not shown) on the inner periphery of the central cylindrical portion 14c. By tightening the movement restricting member 16, which is threadedly coupled to the sliding member described above through the stepped elongated hole 15b, it is possible to selectively restrict or limit the axial displacement of the operating member 14 relative to the handle body 15, or to allow relative displacement of the operating member 14 and the handle body 15 by releasing the restriction or limitation.

The lifting tool 12 is made of metal, such as stainless steel, and has a fork shape that extends in the axial direction of the sheath 11. The lifting tool 12 is interconnected at the base end connected to the operating wire 13, while at the tip end it has multiple claw members 21, 22 spaced a predetermined radial distance apart.

The lifting tool 12 is movable between a storage position where the multiple claw members 21, 22 are stored within the sheath 11 without protruding from the distal end 11a of the sheath 11, and a use position where the multiple claw members 21, 22 protrude outward from the distal end 11a of the sheath 11, as shown in Figure 1. This movement can be controlled by loosening the movement restricting member 16 and displacing the operating member 14, which is connected to the lifting tool 12 via the operating wire 13, in the axial direction relative to the handle body 15 connected to the sheath 11. For example, the surgeon can operate the lifting tool by inserting their index and middle fingers into the finger holes 14a, 14b of the operating member 14 and, for example, inserting their thumb into the finger hole 15a provided at the base end of the handle body 15.

Furthermore, the multiple claw members 21, 22 have a needle shape that can puncture internal body tissue, such as the tissue PP of the digestive tract DT, and have an uneven shape along part of their longitudinal direction.

Specifically, the multiple claw members 21, 22 form a pair of strip-shaped plates facing each other in the radial direction of the sheath 11, and each of the multiple claw members 21, 22 has a concave notch 21c or 22c formed on one side of the lifting tool 12 in the plate width direction.

For example, recessed notches 21c, 22c are formed on one side of the width of the plate of each of the multiple claw members 21, 22 within a predetermined range in the longitudinal direction. These notches open to one side of the width of the plate of the lifting tool 12. As a result, the multiple claw members 21, 22 each have a hook-shaped portion 21b, 22b that is adjacent to the notches 21c, 22c on one side of the width of the plate of the lifting tool 12 and has an edge that forms a roughly L-shaped hook.

Furthermore, the outer diameter of each of the multiple claw members 21, 22 becomes smaller toward the tips 21a, 22a of the concave-convex portions having the respective notches 21c, 22c and hook-shaped portions 21b, 22b.

More specifically, the multiple claw members 21, 22 have a needle-like rectangular cross section, with flat inclined surfaces on both sides of their tips in the width direction of the plate, and flat inclined surfaces only on the outer surface in the thickness direction.

Therefore, when the multiple claw members 21, 22 are inserted from the tip 21a, 22a side until the hooked portions 21b, 22b penetrate into internal tissue, such as tissue PP of the digestive tract DT, the hooked portions 21b, 22b can hold the tissue PP in a non-disconnected state via the internal tissue that enters the notches 21c, 22c.

In addition, when the lifting tool 12 is rotated around its axis via the operating wire 13 by the operating member 14, which is integrally engaged with the handle body 15 in the rotational direction, the internal tissue, such as tissue PP, held in a retained state, is wrapped around the multiple claw members 21, 22, thereby enhancing the retention function of the retained state.

Furthermore, a metal, e.g., stainless steel, guide member 23 is integrally provided on the proximal end side of the multiple claw members 21, 22 of the lifting tool 12, and is capable of sliding on the inner surface of the distal end 11a side of the sheath 11. Taking into account the curvature of the sheath 11 inserted into the endoscope 2, this guide member 23 has a short cylindrical shape with an axial length that is relatively short compared to its outer diameter.

As shown in Figure 4(A), the guide member 23 is arranged around both claw members 21, 22, spaced a predetermined distance L2 from the tips 21a, 22a of the claw members 21, 22 toward the base ends 21d, 22d, and is fixed integrally to the claw members 21, 22 by welding or the like. The guide member 23 may be chamfered at either one end in the axial direction as shown in Figure 4, or at both ends. The predetermined distance L2 is a length that does not penetrate tissue when punctured.

As described above, the handle body 15 is capable of relative axial displacement with respect to the operating member 14, but is engaged in a manner that restricts relative rotation about the axis. Therefore, the lifting tool 12 is displaced axially within the sheath 11 in response to axial operation input of the operating member 14 relative to the handle body 15, or axial operation input of the handle body 15 relative to the operating member 14, but rotates integrally with the sheath 11 in the axial direction in response to rotation input from the proximal end of the operating member 14 or handle body 15.

Of course, if the operating member 14 or the handle body 15 is engaged so as to be rotatable about its axis, the lifting tool 12 can be relatively rotated within the sheath 11 in response to an operation input of the operating member 14 about its axis relative to the handle body 15, or an operation input of the handle body 15 about its axis relative to the operating member 14.

For example, such an engagement state can be achieved by forming multiple circumferential grooves or spiral grooves in the handle body 15 that open radially outward rather than axial grooves. Alternatively, the operating member 14 and handle body 15 can simply be fitted together via their cylindrical surfaces, with movement in any direction restricted by a threaded movement restricting member 16. Furthermore, instead of the sheath 11, a double-structure sheath having an outer sheath connected to the handle body 15 and an inner sheath connected to the operating member 14 can also be used.

The displacement of the multiple claw members 21, 22 relative to the handle body 15 of the operating member 14 is restricted by a screw-type movement restricting member 16 when the tips 21a, 22a of the multiple claw members 21, 22 protrude a predetermined amount L1 (shown in Figure 4(A)) from the tip 11a of the sheath 11. This restricts the relative axial displacement of the sheath 11 and the lifting tool 12.

Therefore, the lifting tool 12 can be fixed in the storage position by tightening the screw-type movement restriction member 16 to prevent axial displacement relative to the sheath 11, and can be moved to the usage position by releasing the tightening of the movement restriction member 16.

In this embodiment, the operating member 14 and handle body 15 are engaged and slidable in the axial direction, so the use position of the lifting tool 12 corresponds to the manual operation of the relative position of the operating member 14 and handle body 15, and is fixed by tightening the movement restricting member 16. However, by providing a feed screw mechanism or the like that can finely adjust the axial position of the operating member 14 and handle body 15, the movement restricting member 16 can be eliminated or reduced to a simple locking mechanism.

In Figures 1 to 4, the multiple claw members 21, 22 have radially opposing inner surfaces that are parallel to each other. However, as shown in Figure 9(A), the multiple claw members 21, 22 may have a free shape that expands toward the tip of the guide member 23 so that the spacing between them becomes wider toward the tip when the lifting tool 12 is in use. In this case, when the lifting tool 12 is retracted to the storage position, as shown in Figure 9(B), the spacing between the multiple claw members 21, 22 becomes approximately uniform and parallel along the axial direction, and they return to the expanded shape shown in Figure 9(A) when use begins.

Next, we will explain how to operate the endoscope 2 when using the endoscopic treatment tool 1.

In this embodiment, the endoscopic treatment tool 1 is rotatable about its axis relative to the endoscope 2, and the endoscope 2 can be rotated about its axis within the digestive tract DT. Therefore, the relative heights and radial positions of the suturing device 3 supported on the distal end 2a of the endoscope 2, and the sheath 11 and lifting tool 12 of the endoscopic treatment tool 1 within the digestive tract DT can be changed by rotating the endoscope 2.

In addition, the postures of the endoscopic treatment tool 1 and the suturing device 3 can be changed by operating them in the axial direction or rotating them around their respective axes.

Furthermore, in this embodiment, a predetermined bending rigidity is set on the tip 11a side of the sheath 11, so that the multiple claw members 21, 22 can lift internal body tissue, such as punctured tissue PP, into the lumen and maintain that lifted state in response to changes in the radial tilt attitude and rotational opening position of the tip 2a of the endoscope 2.

Figures 2, 3, and 6 illustrate changes in the attitude and height of the lifting tool 12 in response to changes in the radial tilt attitude and rotational angle position of the tip 2a of the endoscope 2, but it goes without saying that the lifting attitude and lifting height of internal tissue such as tissue PP by the lifting tool 12 can also be changed by raising the tip 2a of the endoscope 2.

In addition, in order to change the lifting posture and lifting height of internal tissue such as tissue PP using the lifting tool 12 while keeping the posture of the endoscope 2 fixed, it is also possible to use a means for raising the tip 11a of the sheath 11 of the endoscopic treatment tool 1 using a wire drive or the like.

Next, we will explain how it works.

In the endoscopic treatment tool 1 of this embodiment, which is configured and operated as described above, the multiple claw members 21, 22 of the lifting tool 12, which extends in the axial direction of the sheath 11, can puncture internal tissue such as tissue PP at the use position protruding from the tip 11a of the sheath 11. Furthermore, because the multiple claw members 21, 22 have an uneven shape, they can prevent the fork-shaped lifting tool 12 from slipping out after puncturing the tissue PP, allowing the tissue PP to be lifted and held.

Furthermore, when the lifting tool 12 is rotated around its axis, the retention effect is strengthened while also creating a catching effect on the tissue PP, thereby fully exerting the force required to lift the tissue PP and maintain it in a lifted state.

Furthermore, in this embodiment, each of the multiple claw members 21, 22 has an uneven shape on one side of the lifting tool 12 in the plate width direction when lifting the tissue PP. This uneven shape creates a locking effect at multiple locations, and strengthens each locking effect when the lifting tool 12 is rotated to one side around the axis, making it possible to more fully exert the force required to lift the tissue PP and the force required to maintain the lifted state.

In addition, in this embodiment, the sheath 11 includes a flexible tube 11c that is slidably inserted into the endoscope 2. This allows the endoscope 2 and the sheath 11, which holds the lifting tool 12 located at its tip, to be freely displaced relative to each other in the axial direction and rotational direction around the axis. This allows the lifting tool 12, together with the sheath 11, to be appropriately and accurately operated in the puncture direction and/or the retraction direction relative to the tissue PP, enabling reliable operation and support of the lifting tool 12.

In addition, in this embodiment, the lifting tool 12 displaces in the axial direction of the sheath 11 in response to axial operation input of the operating member 14 relative to the handle body 15, while rotating about its axis in response to rotational operation input from the proximal end of the operating member 14 or handle body 15. This makes it possible to appropriately adjust the amount of protrusion L1 of the lifting tool 12 from the distal end 11a of the sheath 11. Furthermore, since the lifting tool 12 can be operated in the puncture direction relative to the tissue PP independently of the sheath 11, and can be rotated in the retraction direction together with the sheath 11, the position of the lifting tool 12 can be easily adjusted in the axial and rotational directions.

In other words, the handle body 15 is displaceable axially relative to the operating member 14, but restricts relative rotation of the operating member 14 about the axis. Therefore, the handle body 15 is displaceable axially relative to the operating member 14 of the lifting tool 12, allowing the lifting tool 12 to be operated in the puncture direction relative to the tissue PP independently of the sheath 11. On the other hand, since the rotation of the operating member 14 about the axis relative to the handle body 15 is restricted by the handle body 15, the lifting tool 12 can be rotated together with the sheath 11 when the operating member 14 is rotated about the axis, making operation easy and stable.

Of course, instead of the sheath 11, a double-structure sheath having an outer sheath connected to the handle body 15 and an inner sheath connected to the operating member 14 may be used so that the lifting tool 12 can be rotated in the retracting direction independently of the sheath 11.

In addition, in this embodiment, a movement restricting member 16 is provided that can restrict displacement of the operating member 14 relative to the handle body 15 when the multiple claw members 21, 22 are in the use position where they protrude a predetermined amount L1 from the tip 11a of the sheath 11.When the displacement of the operating member 14 relative to the handle body 15 is restricted by the movement restricting member 16, the amount L1 of protrusion of the multiple claw members 21, 22 of the lifting tool 12 from the tip 11a of the sheath 11 is fixed to a protrusion amount appropriate for operations such as puncturing, lifting, and wrapping the tissue PP, thereby making these operations significantly easier.

In addition, in this embodiment, a guide member 23 that can slide on the inner surface of the distal end 11a of the sheath 11 is integrally provided on the base end side of the multiple claw members 21, 22 of the lifting tool 12. As a result, the guide member is slidably held on the inner surface 11e of the distal end 11a of the sheath 11, allowing the multiple claw members 21, 22 of the lifting tool 12 to be stored or protruded within the sheath 11 in a suitable position.

Furthermore, the guide member 23 is arranged around the multiple claw members 21, 22, spaced a predetermined distance L2 from the tips 21a, 22a of the multiple claw members 21, 22 toward the base ends 21d, 22d, and is fixed to the multiple claw members 21, 22 by welding or the like. Therefore, it can also function as a stopper that limits the penetration depth of the multiple claw members 21, 22 when they puncture internal tissue such as tissue PP to within a predetermined depth. Note that when a guide member is provided, it does not need to be fixed to all of the multiple claw members; it is sufficient that the guide member be fixed to at least one of the multiple claw members.

In addition, in this embodiment, the multiple claw members 21, 22 of the lifting tool 12 are formed with notches 21c, 22c and hook-shaped portions 21b, 22b adjacent to these notches 21c, 22c so that they have an uneven shape on one side in the plate width direction. This increases the bending rigidity of the multiple claw members 21, 22 in the plate width direction, which is the direction in which the tissue PP engages with the hook-shaped portions 21b, 22b of the multiple claw members 21, 22 and the direction in which the tissue PP is wrapped into the notches 21c, 22c, thereby sufficiently increasing the lifting force of the tissue PP and the force with which it can be held in a lifted state.

Furthermore, the diameter of each of the multiple claw members 21, 22 decreases toward the tip 21a, 22a, closer to the tip than the portion with an uneven shape on one side of the plate width direction due to the hook-shaped portions 21b, 22b and notches 21c, 22c. This makes it easier for the multiple claw members 21, 22 to puncture the tissue PP and makes it less likely for them to come out after puncturing.

As such, this embodiment provides an endoscopic treatment tool 1 that can lift tissue PP in the digestive tract DT toward the lumen while resecting the tissue PP above the suture site at its base, for example, multiple suture target sites ST1 to ST3, with relatively easy endoscopic manipulation, and that can fully exert its lifting force on the tissue PP and its ability to maintain the lifted state.

(Other embodiments)
FIG. 9 illustrates only the essential parts of an endoscopic treatment tool according to another embodiment of the present invention.

In this embodiment, although the shape of the tip end of the lifting tool 12 differs from that of the previously described embodiment, the other configurations are exactly the same as those of the previously described embodiment. Therefore, the differences between this embodiment and the previously described embodiment will be explained below, using the reference numerals of the corresponding components in the previously described embodiment shown in Figures 1 to 8.

As shown in Figure 9 (A), in this embodiment, the multiple claw members 21, 22 of the lifting tool 12 have a free shape in which the distance between them increases as they approach the tips 21a, 22a on the side closer to the tips 21a, 22a than the guide member 23.

For example, the multiple claw members 21, 22 have a free shape in which the radial separation distance d1 between the tips 21a, 22a is greater than the radial separation distance d2 inside the guide member 23 by a predetermined factor d1/d2 (e.g., approximately 1 to 1.5 times).

Then, when the multiple claw members 21, 22 of the lifting tool 12 store the guide member 23 inside the tip 11a of the sheath 11 and reduce the amount of protrusion L1 of the multiple claw members 21, 22 from the tip 11a of the sheath 11 to less than the predetermined distance L2, the separation distance on the tip side of the multiple claw members 21, 22 is narrowed by the sheath 11 to less than separation distance d1. Note that at this time, the tips 21a, 22a of the multiple claw members 21, 22 do not come into contact with the inner surface of the sheath 11.

That is, as shown in Figure 9 (B), the distance between the distal ends of the multiple claw members 21, 22 is approximately the storage-side distance d3, which is closer to the radial distance d2 inside the guide member 23 than the distance d1 between the distal ends 21a, 22a when the sheath 11 projects a predetermined amount L1 from the distal end 11a.

Furthermore, when the multiple claw members 21, 22 of the lifting tool 12 again protrude from the tip 11a of the sheath 11 to the predetermined protrusion amount L1, the multiple claw members 21, 22 elastically recover to their free shape and return to the maximum separation distance d1.

In this embodiment, too, the multiple claw members 21, 22 of the lifting tool 12, which extend in the axial direction of the sheath 11, can puncture internal tissue such as tissue PP at the use position protruding from the tip 11a of the sheath 11. Furthermore, because the multiple claw members 21, 22 have an uneven shape, they can prevent the lifting tool 12 from slipping out once it has punctured the tissue PP, allowing it to lift and hold the tissue PP.

Furthermore, when the lifting tool 12 is rotated around its axis, the retention effect is strengthened while also creating a catching effect on the tissue PP, thereby fully exerting the force required to lift the tissue PP and maintain it in a lifted state.

Furthermore, in this embodiment, the multiple claw members 21, 22 have a free shape that widens toward the tip end so that the distance between them increases toward the tip end 21a, 22a, further strengthening the anti-slip effect provided by the notches 21c, 22c and the hook-shaped portions 21b, 22b.

In the above-described embodiments, the endoscopic treatment tool 1 is used in non-penetrating endoscopic full-thickness resection, but it can also be used as a treatment tool for lifting tissue in other procedures within NOTES, a transluminal endoscopic surgery.

In addition, in the above embodiment, the lifting tool 12 has two claw members 21, 22, but the number can be any number greater than or equal to two.

Furthermore, the notches 21c, 22c and hook-shaped portions 21b, 22b of the multiple claw members 21, 22 position the concave and convex shapes on one side of the plate width within the same area within a predetermined axial distance L2, but the concave and convex shapes may be positioned on both sides of the plate width, or may be positioned in different areas within the predetermined axial distance L2.

Of course, one of the claw members 21 may have not only the concave-convex shape formed by the notch 21c and the hook-shaped portion 21b, but also a different concave-convex shape on one side at a different axial location. Similarly, the other claw member 22 may have not only the concave-convex shape formed by the notch 22c and the hook-shaped portion 22b at one location, but also a different concave-convex shape on the other side at a different axial location. Furthermore, the depths and shapes of the multiple recesses and the heights and shapes of the protrusions formed on the same claw member 21 or 22 may be different or the same. Furthermore, the number, size, and shape of the concave-convex shapes may be different on one side and the other in the rotational direction around the axis, varying the strength of the retention effect depending on the direction of rotation. Furthermore, when the claw members have concave-convex shapes, it is not necessary for all of the claw members to have concave-convex shapes; it is sufficient for at least one claw member to have a concave-convex shape.

Furthermore, each of the claw members 21, 22 is a substantially straight plate-shaped member at the tip end of the guide member 23, but it may be curved in the thickness direction, or the width of the plate may change so that both side surfaces in the width direction form curved surfaces.

As explained above, the present invention provides an endoscopic treatment tool that can ensure sufficient and stable lifting force for internal tissue and the ability to maintain that lifted state with relatively easy endoscopic manipulation, and is useful as an endoscopic treatment tool for lifting internal tissue under endoscopy.

DESCRIPTION OF SYMBOLS 1 Endoscopic treatment tool 2 Endoscope 2a Distal end portion 2b Treatment tool passage 3 Suturing device 3a Fitting tube portion 3b Outer cover 11 Sheath 11a Distal end portion 11b Mouthpiece member 11c Flexible tube 11d Base end portion 11e Inner surface 12 Lifting tool 13 Operating wire 13a Distal end portion 13b Base end portion 14 Operating member 14a, 14b, 15a Finger hole portion 14c Central tube portion 15 Handle body 15b Stepped elongated hole portion 16 Movement restriction member (displacement restriction mechanism)
21, 22 Claw member (plurality of claw members)
21a, 22a Tip 21b, 22b Hook-shaped portion 21c, 22c Notch 21d, 22d Base end 23 Guide member 31 Front arm 31a, 31b Storage space 32 Rear arm 32a, 32b Needle member 32c, 32d Neck portion 33 Arm movement mechanism 34 Suture 34a, 34b Both ends 35a, 35b Engaging member 71 Dissection treatment tool 72 Retrieval treatment tool 81 Suture ligation tool 82 Suture ligation device d1, d2 Separation distance d3 Storage-side separation distance DT Digestive tract L1 Protrusion amount L2 Predetermined distance PP Tissue (tissue with a lesion, internal tissue)
ST1, ST2, ST3 Suturing area

Claims (10)

a tubular sheath;
an operating wire inserted into the sheath;
a tool disposed on the distal end side of the sheath;
a handle body connected to a proximal end side of the sheath;
an operating member operably connected to the tool via the operating wire and sliding the operating wire relative to the handle body at least in the axial direction of the sheath,
the tool has a plurality of claw members that are movable between a storage position where the tool is stored at the distal end side of the sheath and a use position where the tool protrudes outward from the distal end of the sheath,
Each of the plurality of claw members has a needle shape capable of puncturing body tissue, and at least one of the plurality of claw members has an uneven shape,
an endoscopic treatment instrument, characterized in that the tool is displaced in the axial direction of the sheath in response to an axial operation input of the operating member relative to the handle body, and rotates in an axial direction in response to a rotation operation input from the operating member or the proximal end side of the handle body . The endoscopic treatment tool according to claim 1, characterized in that each of the multiple claw members has an uneven shape. An endoscopic treatment tool according to claim 1 or 2, characterized in that the sheath includes a flexible tube that is slidably inserted into the endoscope. 4. The endoscopic treatment tool according to claim 1, wherein the plurality of claw members are connected to one another on the proximal end side of the tool that is connected to the operating wire . 5. The endoscopic treatment tool according to claim 1 , wherein the handle body is engaged with the operating member so as to be displaceable relative to the operating member in the axial direction, but to restrict relative rotation about the axis. An endoscopic treatment tool according to any one of claims 1 to 5, characterized in that a displacement restriction mechanism is provided that can restrict axial displacement of the operating member relative to the handle body at a position where the multiple claw members protrude a predetermined amount from the tip of the sheath. An endoscopic treatment instrument according to any one of claims 1 to 6, characterized in that a guide member that is slidable on the inner surface of the distal end side of the sheath is integrally provided on the proximal end side of the multiple claw members of the tool. The endoscopic treatment tool according to claim 7, characterized in that the guide member is arranged around the plurality of claw members at a predetermined distance from the distal end toward the proximal end of the plurality of claw members and is fixed to at least one of the plurality of claw members. An endoscopic treatment tool according to any one of claims 1 to 8, characterized in that the multiple claw members are strip-shaped and face each other in the radial direction of the sheath, and at least one of the multiple claw members corresponding to one side in the axial direction has a notch with the concave-convex shape formed on one side in the width direction of the plate, and a hook-shaped portion is formed adjacent to the notch. The endoscopic treatment tool according to any one of claims 1 to 9 , wherein at least one of the plurality of claw members is located on the distal end side of the portion having the uneven shape, and the diameter of the claw members decreases as it approaches the distal end.