JP2024032200A - Clip unit for ligation device - Google Patents

Abstract

To provide a clip unit for a ligation device capable of gripping one wall surface of a large wound, reliably closing the wound by bringing the gripped one wall surface close to the other wall surface and bringing both side parts of mated paired hole walls close to the paired hole walls, and being placed in a body cavity.SOLUTION: A clip unit comprises a clip unit body 8a including a four-pronged arm part 11, and a fastening ring 30. The four-pronged arm part 11 includes first and second arm legs 12 and 13, the tip sides of which are slightly opened and that generate accumulation return force when the legs are closed, and third and fourth arm legs 14 and 15, the tip sides of which are wide opened and that generate accumulation return force when the legs are closed. When the fastening ring 30 is located at a first fitting position C, tip portions 12c and 13c of the first and second arm legs 12 and 13 are closed together, and when the fastening ring 30 is located at a second fitting position B, the tip portions 14c and 15c of the third and fourth arm legs 14 and 15 are closed together.SELECTED DRAWING: Figure 3

Description

The present invention is used as a tip member of a ligation device, which is an endoscopic treatment instrument that is passed through a channel of an endoscope, guided to a position facing any affected area in the digestive tract, and pinched the affected area to stop bleeding. The present invention relates to a clip unit for a ligation device, which is inserted into a body cavity of a living body, pinches an affected area, stops bleeding, etc., and is separated as it is and left in the digestive tract.

The ligation device includes an operating section located on the proximal end side of the channel of the endoscope, a flexible inner sheath connected to the operating section via a coupling section, and a flexible inner sheath connected to the operating section from the distal end of the coupling section. A flexible outer sheath fitted at the distal end position, an operating wire extending distally from the slider of the operating section and inserted into the vicinity of the distal end of the inner sheath, and a distal end provided at the distal end of the inner sheath. The clip unit has an arm portion that is elastically open and then tightened by a tightening ring to be closed, and the proximal end of the clip unit is chucked by the connection release tool.

In the clip unit, the inner sheath is moved forward by operation on the operating section from a state where the arms in the open state are set in a position where they can clamp the affected area in the digestive tract, and the tightening ring is attached to the distal end of the inner sheath. When the tightening position of the arm is moved to the distal side, the arm part is closed and clamps the affected area in the digestive tract, and in this state, the unzipping tool is released from the chuck, separating it from the ligation device and releasing it inside the digestive tract. left behind.

Examples of clip units of conventional ligation devices include Patent Document 1 and Patent Document 2.

The clip unit described in Patent Document 1 has a sharp protrusion near the claws at the tips of a pair of arm plates, and is used to stitch together both sides of a mucous membrane defect after resection of a tumor or the like. When contracting, the protrusions pierce the mucous membrane, so that each claw of the pair of arm plates can pull together both sides of the mucous membrane defect without slipping on the mucous membrane, and the pulled mucous membrane defect By grasping both sides of the arm with a pair of claws, the defect can be sutured, and if the wound is within the range of the two arm legs spread apart, the wound can be closed. can.

The clip unit described in Patent Document 2 includes an arm leg having a claw at the tip, an arm tip leg having a claw at the tip that is wide open with respect to the arm leg, and an arm leg that branches from the middle of the arm tip leg to form the arm leg. The opening of the wound is reduced by narrowing the gap between the small open arm leg and the arm branch leg as the tightening ring is moved toward the distal end of the arm leg. A wide open wound can be easily ligated by holding one edge of the wound, moving one edge of the opening of the wound in this pinched state to the other edge, and moving the tightening ring toward the tip of the arm to a position beyond the bifurcation point. With this, one wall of the affected area in the hole state after the lesion has been excised is clamped, the clamped wall is moved to the other wall, the walls are sutured together, and the affected area is exposed after suturing. Never.

JP 2015-8858 Publication JP2017-176335A

For example, the clip unit described in Patent Document 1 may be able to suture a wound with a diameter of 6 mm or less, but it is difficult to suture a large hole. When suturing the wound (hole) of a lesion, suturing is done with thread in the case of surgery, but when suturing the hole using an endoscope, it is necessary to suture the walls on both sides of the lesion hole. , it is difficult to apply to suture wounds of lesions larger than 6 mm. It would be impossible to hook one wall surface with one nail and move it to the other wall surface, and hook the other wall surface with the other nail to suture the walls on both sides of the lesion hole.

The clip unit described in Patent Document 2 clamps one wall surface of a wound with an arm leg and an arm branch leg and moves it to the other wall surface of the wound, but at this time, a considerably large load is applied to the arm leg and arm branch leg. Because of this, the arm legs and arm branch legs require great strength and springiness.

Furthermore, it is important for the clip unit described in Patent Document 2 to have sufficiently high springiness in the arm leg, the arm tip leg, and the arm branch leg in the following points. That is, due to the structure, the opening width of the arm leg and the arm branch leg is half that of the clip unit described in Patent Document 1, and in addition, the arm leg and the arm tip leg are opened in order to allow the endoscope to pass through. The flexible sheath is inserted with the arm branch leg closed, but if the spring properties are poor, the opening width of the arm leg and the arm branch leg will inevitably be reduced after this insertion. There is a problem that due to the spring property, the opening width does not return to the fully open state and shrinks, resulting in a situation where the width to grip the wall surface of the affected area cannot be secured. In order to avoid this, special metals and special manufacturing methods, such as selection of metal materials with high spring properties, are required. Currently, the arm has a three-pronged structure with arm legs, arm tip legs, and arm branching legs.Due to the manufacturing process, laser cutting or etching cuts out at high temperatures, and sulfuric acid causes the material to lose its springiness. Due to this effect, it is impossible to use anything other than press in terms of product, and there is a problem in that the press process is complicated and it is not possible to secure the opening width between the arm leg and the arm tip leg, making it difficult to manufacture the product at present.

The present invention was made in view of this situation, and has a four-pronged structure with two pairs of arm parts that can be opened and closed, and the pair of arm parts can grip one wall of a large wound. A ligature that has the function of bringing one wall surface close to the other wall surface, and then bringing both sides of the paired hole wall, which are joined by another pair of arms, toward the paired hole wall, thereby reliably closing the wound and indwelling it in the body cavity. An object of the present invention is to provide a clip unit for a device.

In order to achieve the above-mentioned object, the first aspect of the invention of the present application is to provide a ligating device that is inserted into a channel of an endoscope and inserted into a body cavity of a living body to grip an affected area and stop bleeding, etc. A clip unit for a ligation device that is provided and separated after a treatment and left in the body,
A four-pronged arm having first to fourth arm legs integrally extending from a proximal end connection portion that is chucked by a connection release tool connected to the tip of the operation wire of the ligation device, and having a claw at the tip of each arm leg. It has an arm part and a tightening ring that is fitted onto the proximal end side of the four-pronged arm part and is provided so as to be slidable in the distal direction by operation of the ligation device,
The four-pronged arm section has first and second arm legs that begin to widen in the middle and have a bifurcated tip with a required spacing between them, increasing the stock return force in the closing direction, and A configuration including third and fourth arm legs which begin to widen from the middle of the tip side and whose tips are bifurcated with a required gap larger than those of the first and second arm legs, and which increase the stock return force in the closing direction. It is.

The base end of the first arm leg and the base end of the third arm leg are side by side, and the base end of the second arm leg and the base end of the fourth arm leg are side by side. are arranged side by side, and the fitted state in which the four corners of the cross section of the base end portions of the first to fourth arm legs are in contact with the inner circumferential surface is defined as an initial fitted position;
When the tightening ring moves from the initial fitted position to a first tightening position separated by a predetermined distance in the distal direction, the distal end portions of the first and second arm legs close together, and the tightening ring further closes together. The tightening ring is configured such that the distal end portions of the first to fourth arm legs are closed together when the tightening ring is moved to a second tightening position spaced apart by a required dimension in the distal direction.

A second invention aspect of the present application includes, in addition to the configuration of the first invention aspect,
The first and second arm legs extend integrally from the proximal end connecting portion and form the proximal end portion which is the initial fitted position of the tightening ring, and the proximal end portion which is the initial fitting position of the tightening ring. and a first clamping portion that is a distal end portion and extends substantially parallel to each other;
The third and fourth arm legs extend integrally from the proximal end connecting portion and form the proximal end portion which is the initial fitted position of the tightening ring, and the proximal end portion which is a midway portion and is curved to widen toward the tip. This configuration includes a second widening portion located at the tip end portion, and a second holding portion that is a tip end portion and has a predetermined intersection angle so as to gradually open toward the tip end.

A third invention aspect of the present application includes, in addition to the configuration of the second invention aspect,
When the tightening ring moves from the initial fitted position to the first tightening position which is a required distance apart in the distal direction, the tightening ring moves to the first tightening position at a midway portion between the first and second arm legs. When the widening portion is tightened to close the first clamping portion, which is the distal end portion, and the tightening ring is further moved to a second tightening position separated by a required distance in the distal direction, the tightening ring After tightening the second widening part of the middle part of the third and fourth arm legs, the second clamping part which is the tip part is tightened, and the second clamping of the third and fourth arm legs is performed. The structure is such that the parts are closed together.

A fourth invention aspect of the present application includes, in addition to the configuration of the first invention aspect,
The pair of claws provided at the tips of the first and second arm legs are oriented toward the center of opening and closing, and are arranged to overlap front and back when the tips of the first and second arm legs are closed together. and
The pair of claws provided at the tips of the third and fourth arm legs face toward the opening/closing center side, and overlap front and back when the tips of the first and second arm legs are closed together. The configuration is as follows.

A fifth invention aspect of the present application includes, in addition to the configuration of any one of the first to fourth invention aspects,
The claws extending from the tips of the first and second arm legs and the third and fourth arm legs are formed to have a wide width and extend in a direction opposite to the third and fourth arm legs. Ori,
The claws extending from and near the tips of the third and fourth arm legs are wide and extend on the opposite side in the plate width direction from the first and second arm legs. This is a configuration where there is

A sixth invention aspect of the present application includes, in addition to the configuration of any one of the first to fourth invention aspects,
The four-pronged arm portion has an initial fitted position where the tightening ring is fitted onto the proximal end sides of the first to fourth arm legs, and a first clamping position of the pair of the first and second arm legs. the first tightening position of the tightening ring when the parts are closed together; and the tightening position when the second clamping parts of the pair of third and fourth arm legs of the tightening ring are closed together. At each of the second tightening positions of the attachment ring, the attachment ring has a plurality of protrusions that can be climbed over and abutted against the tightening ring to prevent it from moving toward the proximal end.

According to the present invention, it has a four-pronged structure with two pairs of arms that can be opened and closed, and the pair of arms can grasp one wall of a large wound and bring one wall close to the other. It is possible to provide a clip unit for a ligating device that has the function of bringing both side portions of the paired hole wall joined by the other pair of arm portions toward the paired hole wall to reliably close the wound and indwelling it in the body cavity.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view schematically showing the overall configuration of a ligation device including a clip unit according to an embodiment of the clip unit of the present invention. (A) Figure is an enlarged sectional view of the distal end of the ligating device including a disconnection tool that chucks the clip unit, and (B) Figure is an enlarged cross-sectional view of the distal end of the ligation device with the clip unit chucked by the disconnection tool. It is a diagram. Regarding the embodiment of the clip unit of the present invention, (A) is a perspective view when the clip unit is in an open state, (B) is an exploded perspective view of the clip unit, and (C) is an exploded perspective view of the clip unit. Figure (D) is an exploded perspective view of the four-pronged arm portion when assembled and manufactured, and FIG. Regarding the embodiment of the clip unit of the present invention, (A) is a perspective view when the four-pronged arm portion is in an open state, (B) is a perspective view when the clip unit is in an open state, (C) is a perspective view when the clip unit is in an open state. The figure is a perspective view showing the state in which the first and second arm legs are tightened by the tightening ring and closed together, and the figure (D) is the state in which the first to fourth arm legs are tightened and closed together by the tightening ring. FIG. Regarding the embodiment of the clip unit of the present invention, (A) is a front view when the clip unit is in an open state, (B) is a rear view when the clip unit is in an open state, and (C) is a front view when the clip unit is in an open state. ) Figure is a front view showing the state in which the first and second arm legs are tightened and closed together by the tightening ring, and Figure (D) is a front view showing the state in which the first to fourth arm legs are tightened and closed together by the tightening ring. It is a front view showing a state. The clip unit according to the embodiment of the present invention is attached to the ligation device, and (A) shows the four-pronged arm portion of the clip unit being opened and the base end connecting portion being chucked by the connection release tool of the ligation device. Figure (B) is a side view showing a part of the arrangement state before the disconnection, and the inner sheath is moved forward from the state shown in Figure (A) until it covers the uncoupling tool and the tightening ring, the uncoupling tool is closed, and the uncoupling tool is closed. (C) is a front view of the same state as (B), and (D) is a side view showing the state where the proximal end connecting part of the clip unit is chucked. FIG. 4 is a front view showing a state in which the first to fourth arm legs are deflated by the outer sheath after being advanced until they cover the outer sheath. The clip unit according to the embodiment of the present invention is shown being closed, and (A) is a front view showing a state where the outer sheath has been retreated from the state shown in (A) of FIG. 5 to a position where it does not cover the connection release tool. Figure (same view as Figure 5 (C)) and Figure 5 (B) show the tightening ring in the first position by advancing the inner sheath relative to the operating wire and disconnection tool from the state in Figure 5A. It is a front view which shows the state which moved to the tightening position and closed the 1st and 2nd arm leg. 6(A) shows the clip unit according to the embodiment of the present invention being separated after being closed, and FIG. (B) is a side view showing the state in which the first to fourth arm legs are closed together. Figure (B) is a side view showing the state in which the inner sheath is relatively retreated from the state in Figure (A) to a position where it does not cover the connection release tool. FIG. 6 is a side view showing a state in which the connection release tool is opened by the force of the return force and the chuck of the base end connection portion of the clip unit is released. A ligation device equipped with a clip unit according to an embodiment of the present invention is used to abut the first and second arm legs so as to sandwich one wall of a wide open wound (affected area) in a living tissue, for example, a digestive tract. Figure (B) is a perspective view showing the state shown in Figure (A) when the first and second arm legs are closed and one wall of the wound is held between the first and second arm legs. Figures (C) and (C) are perspective views showing the situation in which the first and second arm legs are moved from the state shown in Figure (B) toward the other wall of the wound to bring one wall of the wound closer to the other wall. Figures and (D) are from the state shown in Figure (C), where the third and fourth arm legs are closed and the third and fourth arm legs are used to pinch both sides of both walls of the wound. FIG.

DESCRIPTION OF THE PREFERRED EMBODIMENTS A clip unit for a ligation device according to an embodiment of the present invention will be described below with reference to the drawings.

[About the ligation device]
The ligation device is passed through a channel of an endoscope and pinches a living tissue, for example, an arbitrary diseased part in the digestive tract, to stop bleeding or the like. The clip unit constitutes the tip of the ligation device, and is operated by operating the operating section of the ligation device and is used to pinch the affected area and stop bleeding, etc. First, let us explain the general configuration of the ligation device. explain.

FIG. 1 shows an exploded perspective view showing a schematic configuration of a ligation device 1. As shown in FIG. The ligation device 1 has an operating section 2 that is operated by a doctor or the like, and a portion distal to the operating section 2 is inserted into the channel of the endoscope until the operating section 2 is inserted into the channel of the endoscope. , the outer sheath 5, the inner sheath 4, the disconnection tool 7, and the clip unit 8 are projected toward the tip of the channel and inserted to any affected area within the digestive tract.

The ligation device 1 is connected to an operating portion 2, a male cylindrical connecting portion 3a provided at the distal end of a cylindrical shaft portion 2a of the operating portion 2, and the male cylindrical connecting portion 3a by fitting or screwing. a flexible inner sheath 4 that integrally extends forward from the distal end surface of the female cylindrical coupling portion 3b; an outer sheath 5 that is flexible, an operating wire 6 that is connected to the slider 2b of the operating section 2 and inserted so as to extend inside the distal end of the inner sheath 4; The clip unit 8 includes a connection release tool 7 whose base end is connected to the tip of the operation wire 6, and a clip unit 8 whose base end is connected to the connection release tool 7 by a chuck.

A large-diameter cylindrical knob 5a is fitted and fixed at the proximal end of the outer sheath 5, and the doctor pinches the knob 5a with his fingers and pushes and pulls the outer sheath 5 against the inner sheath 4 in the axial direction. Can be slid. The inner sheath 4 includes an inner sheath body 4a made of, for example, tightly wound stainless steel wire with a rectangular cross section, and a holding cylinder 4b made of, for example, a stainless steel pipe and extended and connected to the tip of the inner sheath body 4a.

As shown in FIG. 2(A), the holding cylinder 4b has a tightening ring accommodating portion 4b1 that can accommodate the tightening ring 30 inside the tip, and has a chuck constriction portion 4b2 at the back thereof.

The operation part 2 includes a cylinder shaft part 2a which is divided into two by a slit 2a1 passing through the diameter at a predetermined length from the base end, and a cylinder shaft part 2a that is fitted onto the outer peripheral surface of the base end side of the cylinder shaft part 2a and is inserted through the slit 2a1. The slider 2b includes a slider 2b having a diameter connecting portion 2b1 and sliding in the axial direction, and a finger ring 2c attached to the base end of the cylindrical shaft portion 2a. The slider 2b has a finger hook part 2b2.

As shown in FIG. 2(A), the uncoupling tool 7 is a molded body having spring properties, has a closed proximal end, is located inside the inner sheath 4, is connected to the distal end of the operating wire 6, and is connected to the distal end of the operating wire 6. It is a bifurcated arm whose opening gradually becomes larger on the tip side, and has an inward chuck claw at each tip.

When the inner sheath 4 is moved forward, the connection release tool 7 is configured such that when the chuck constriction part 4b2 of the inner sheath main body 4a is covered, the external pressure of the chuck constriction part 4b2 acts and the bifurcated arm increases the stock return force. As a result, the pair of inward chuck claws 7a, 7b can chuck the end face portion of the proximal end connecting portion 10 of the clip unit 8 in a state where it is held therein.

In the ligation device 1, the doctor slides the slider 2b toward the rear end by hooking his or her fingers on the finger ring 2c and the finger hook 2b2 of the slider 2b and shortening the distance between the finger ring 2c and the finger hook 2b2. This allows the inner sheath 4 to move toward the distal end in a position where it covers the connection release tool 7 (see FIGS. 2(B), 6(B), and 7(A)), and a position where it covers the clip unit 8 (see FIG. 7(B) and FIG. 8(A)). Further, the doctor can move the entire device forward and backward by placing his or her finger on the finger ring 2c and pushing and pulling it in the distal direction or the proximal direction.

Note that the configurations of the operating section 2 and the connection release tool 7 are not limited to the above configurations.

[Configuration of clip unit 8]
As shown in FIGS. 3(A), 3(B), and 3(C), the clip unit 8 for the ligation device has a clip unit main body 8a and an initial fitted position A near the proximal end of the clip unit main body 8a (FIG. 3(A) The clip unit main body 8a includes a proximal end connecting portion 10 that is chuck-connected to the uncoupling tool 7 of the ligation device 1, and a tightening ring 30 that is fitted in position It consists of a four-pronged arm portion 11 that extends forward and has a claw at the tip of each arm. The tightening ring 30 may be a cylindrical molded body having a required diameter and not expanding in diameter, and although it is cylindrical in the illustrated example, it may be a rectangular cylinder or even a coil.

As shown in FIGS. 3(A), 4(A), and (B), the clip unit 8 has a proximal end connecting portion 10 that can be connected and released by the chuck using the connecting release tool 7 of the ligation device 1. The ligation device 1 is separably provided at the tip of the ligation device 1, and is inserted into the body cavity of a living body, and the four-pronged arm portion 11 is opened and then closed in two stages to form the configuration shown in FIG. After the treatment, the connection release tool 7 is released from the ligature device 1 and left in the body cavity.

[Configuration of proximal connection portion 10]
As shown in FIGS. 6(A) and 6(B), the proximal end connecting portion 10 may have any configuration as long as it can be disconnected by the disconnecting tool 7 of the ligation device 1. The proximal end connecting portion 10 of this embodiment is preferably not a separate component from the four-pronged arm portion 11, but is formed integrally with the four-pronged arm portion 11 by press molding, for example, a stainless steel plate. As shown in FIGS. 3(B) and 4(A), the proximal end connecting portion 10 shown in this embodiment has an end surface that is held by the pair of chuck claws 7a, 7b of the connection release tool 7 of the ligation device 1. It is a three-sided frame portion including a portion 10a and inverted trapezoidal side portions 10b, which are bent at right angles from a pair of opposite sides of the end surface portion 10a and whose width increases as the distance from the end surface portion 10a increases.

[Configuration of four-pronged arm portion 11]
As shown in FIGS. 3(A)-(C) and FIG. 4(A)-(D), the four-pronged arm portion 11 is formed by bending a stainless steel plate in the plate thickness direction by press-forming, with a small opening of about 6 mm, for example. The structure includes first and second arm legs 12, 13 that are in a closed state, and third and fourth arm legs 14, 15 that are opened by press molding, for example, about three times as wide.

The first and second arm legs 12, 13 have a small opening, for example, 6-8 mm, and the third and fourth arm legs 14, 15 are the same as the first and second arm legs 12, 13. It is wide open, for example, about three times the opening width.

FIG. 3(C) is an exploded perspective view showing an example of the manufacturing process of the clip unit main body 8a.

In this embodiment, the third and fourth arm legs 14 and 15 are shaped by press molding so that the base end portions have the same wide width as the base end connecting portion 10, and then are bent by press molding to open wider. The width of the third and fourth arm legs 14, 15 other than the base end portions is half the width of the wide base end portions of the third and fourth arm legs 14, 15.

Further, the first and second arm legs 12 and 13 are shaped by press molding to have half the width of the wide base end portions of the third and fourth arm legs 14 and 15, and then pressed to open even smaller. It is bent by molding. Then, the base end portions of the first and second arm legs 12, 13 are brought into contact with the stepped portions of the base end portions of the third and fourth arm legs 14, 15 in the plate width direction, and the stepped portion contact surfaces and The side abutting surfaces are integrated by laser welding, so that the proximal ends of the first and second arm legs 12, 13 have sufficient welding strength.

As can be seen from FIGS. 3 and 4, the thickness of the first to fourth arm legs 12-15 is visible when viewed from the direction perpendicular to the opening direction, and the thickness of the first to fourth arm legs 12-15 is visible when viewed from the direction perpendicular to the opening direction. 12 and 13 appear to have a bent shape with a small opening, and the third and fourth arm legs 14 and 15 appear to have a bent shape with a wide opening.

FIG. 3(D) is an exploded perspective view showing another example of the manufacturing process of the clip unit main body 8a. In this modification, the first and second arm legs 12, 13 and half of the proximal end connecting portion 10 are integrated into a bifurcated arm shape, and the third and fourth arm legs 14, 15 are connected to the proximal end. The other half of the section 10 is integrated into a bifurcated arm shape, and is divided into two parts. In this modification, the halves of the base end connecting portion 10 are joined together, the base ends 12a, 13a of the first and second arm legs 12, 13, and the base ends of the third and fourth arm legs 14, 15. Since the joints 14a and 15a are formed, the joint strength is increased and the elastic shape of the bifurcated arm when molded is strongly maintained.

As yet another modification, contrary to the above, the base end portions of the first and second arm legs 12, 13 are wide and press-molded integrally with the base-end connecting portion 10, and the base end portions of the first and second arm legs 12, 13 are press-molded integrally with the base-end connecting portion 10, and The base end portions of the third and fourth arm legs 14 and 15 may be in contact with the base end connecting portion 10 and the base end portions of the first and second arm legs 12 and 13 and laser welded. .

As can be seen from FIGS. 3(B) and 4(A), the clip unit main body 8a has a base end 12a of the first arm leg 12 and a base end 14a of the third arm leg 14 in the plate width direction. The base end portion 13a of the second arm leg 13 and the base end portion 15a of the fourth arm leg 15 are integrally arranged side by side in the board width direction, and the first to fourth arms With the four corners of the cross-sectional shape perpendicular to the longitudinal direction of the base end of the legs 12-15 in contact with four places on the inner peripheral surface of the tightening ring 30, the tightening ring 30 is attached to the first to fourth sections. It is fitted into the base end of the arm leg 12-15.

Furthermore, with reference to FIGS. 3(A) and 4(A), the bending shape and opening shape of the first to fourth arm legs 12-15 and the effect of the tightening force of the tightening ring 30 will be described in detail.

The first and second arm legs 12 and 13 have a required length that integrally extends forward from the side surfaces 10b and 10b of the proximal connecting portion 10 when the tightening ring 30 is in the initial fitted position A. base end portions 12a, 13a, first widening portions 12b, 13b extending in an inclined straight line from the base end portions 12a, 13a, and extending substantially parallel to each other from the first widening portions 12b, 13b. The bent shape and open shape including the first holding portions 12c and 13c are maintained. Then, when the tightening ring 30 comes to the first tightening position B, the proximal ends of the first clamping parts 12c and 13c are connected to each other, and the first widening parts 12b and 13b and the first clamping part 12c, 13c close together.

The third and fourth arm legs 14 and 15 have proximal ends of a required length that extend integrally from the side surfaces 10b and 10b of the proximal end connecting portion 10 when the tightening ring 30 is in the initial fitted position A. The parts 14a, 15a, the second widening parts 14b, 15b that curve outwardly from the proximal ends 14a, 15a, and the second widening parts 14b, 15b at a predetermined intersection so that they gradually open toward the distal ends. The bent shape and open shape including the second holding portions 14c and 15c having corners are maintained. The second widening portions 14b and 15b do not start closing even when the tightening ring 30 comes to the first tightening position B, and the tightening ring 30 comes to the second tightening position C. Then, the second clamping parts 14c, 15c and the second clamping parts 14c, 15c close together.

When the tightening ring 30 is fitted into a first fitting position near the proximal end of the four-pronged arm part 11, the spreading base end of the first widening parts 12b, 13b is the position of the tightening ring 30 at the first fitted position near the proximal end of the four-pronged arm part 11. 30, and at this time, since the tightening force of the tightening ring 30 does not act on the first widened portions 12b, 13b, the first clamping portions 12c, 13c are slightly opened at the required spacing during press molding. Therefore, when the tightening force of the tightening ring 30 is applied, the return force is increased in the closing direction.

The expanding proximal ends of the second expanding portions 14b, 15b on the arc are located a predetermined distance farther forward than the expanding proximal ends of the first expanding portions 12b, 13b, and the tightening ring 30 The second widened portions 14b, 15b are press-molded. They are wide open at a required interval, and when the tightening force of the tightening ring 30 is applied, the force to return the stock is increased in the closing direction.

Approximately half of the distal ends of the first clamping parts 12c and 13c extend widely outward in the board width direction (in the direction opposite to the third and fourth arms). In addition, approximately half of the tip sides of the second clamping parts 14c and 15c extend widely outward in the board width direction (in the direction opposite to the first and second arms), so that all the arms shown in FIG. 4(D) In the closed state, the tightening ring 30 is prevented from moving any further toward the distal end. Further, the claws 16 and 17 extending from the respective tips of the first clamping parts 12c and 13c are provided so as to be offset from each other and face each other. Furthermore, the claws 18 and 19 extending from the respective tips of the second holding parts 14c and 15c are provided so as to be offset from each other and face each other.

As shown in FIGS. 4 and 5(A)-(D), the four-pronged arm portion 11 is initially fitted with the tightening ring 30 on the proximal end side of the first to fourth arm legs 12-15. Position A (FIG. 5(A)) and the first tightening position of the tightening ring 30 when the pair of first clamping parts 12c, 13c of the first and second arm legs 12, 13 are closed together. B (FIG. 5(C)) and the second gripping portion 14c, 15c of the tightening ring 30 when the pair of second clamping portions 14c, 15c of the third and fourth arm legs 14, 15 of the tightening ring 30 are closed together. At each of the tightening positions C (FIG. 5(D)), the tightening ring 30 can be climbed over by pressing strongly from the proximal end side by operating the operating section, and after getting over, the tightening ring 30 can be moved from the proximal end side. The structure may include a plurality of protrusions 20a and 20b that prevent the tightening ring 30 from moving toward the proximal end by contacting the protrusions 20a and 20b. Each arm leg tries to push the ring back toward the proximal end side as it tries to expand in the opening direction in response to the tightening of the tightening ring 30 in the closing direction. By contacting the proximal end of the tightening ring 30 with the protrusion, the tightening ring 30 is positioned at each of the first tightening position B and the second tightening position C without returning to the proximal direction.

[About movement of tightening ring 30]
To move the tightening ring 30 from the initial fitted position A to the first tightening position B and further to the second tightening position C, first move the slider 2b of the operating section 2 against the cylinder shaft section 2a. This can be done by moving in the direction.

FIG. 4(A) shows a perspective view of the clip unit main body 8a (molded body of the proximal end connecting portion 10 + four-pronged arm portion 11; configuration of the portion not including the tightening ring 30; see FIG. 3(B)). FIG. 4(B) shows a state in which the tightening ring 30 is forcibly fitted into the initial fitting position A of the clip unit main body 8a. In this state, the tightening ring 30 does not exert any tightening force on the four-pronged arm portion 11, and the first to fourth arm legs 12-15 are opened into four parts in the initial state of assembly.

4(C) and FIG. 5(C) show a state in which the tightening ring 30 has moved from the initial fitted position A to the first tightening position B of the clip unit main body 8a. As can be seen from FIGS. 7A and 7B, the movement of the tightening ring 30 from the initial fitted position A to the first tightening position B is performed by moving the inner sheath 4 in the forward direction. . When the tightening ring 30 is located at the first tightening position B, it tightens the first widened portions 12b, 13b of the first and second arm legs 12, 13, thereby tightening the first and second arm legs 12, 13. are closed together, and the pair of claws 16 and 17 pass each other and overlap front and back toward the center of opening and closing.

FIGS. 4(D) and 5(D) are perspective views of the state in which the tightening ring 30 has been moved to the second tightening position C of the clip unit main body 8a. As can be seen from FIGS. 7(B) and 8(A), the movement of the tightening ring 30 from the first tightening position B to the second tightening position C moves the inner sheath 4 further forward. It is done by doing. When the tightening ring 30 is located at the second tightening position C, it tightens the second clamping parts 14c and 15c of the third and fourth arm legs 14 and 15, and the first and second arm legs 12 and 13 are tightened. In addition, the third and fourth arm legs 14 and 15 are closed together, and the pair of claws 18 and 19 face toward the opening/closing center side and overlap one another front and back. Note that while the tightening ring 30 is moving while tightening the second spread portions 14b, 15b in front of the second clamping portions 14c, 15c at the second tightening position C, the third and fourth arm legs 14 , 15 close together.

[Explanation of treatment movements]
Referring to FIGS. 4 to 9, a procedure for treating an affected area within the digestive tract using the ligation device 1 equipped with the clip unit 8 will be described.

As shown in FIG. 6(A), in order to attach the clip unit 8 to the distal end of the ligation device 1, the inner sheath 4 and the outer sheath 5 are placed in a retracted position where they do not cover the connection release tool 7, and thereby the connection release tool A pair of chuck claws 7a and 7b of 7 are in an open state. Then, the proximal end connecting portion 10 of the clip unit 8 is set in a relative position where it is held by the pair of chuck claws 7a, 7b of the disconnecting tool 7.

Then, as shown in FIGS. 6(B) and 6(C), only the inner sheath 4 is moved forward to a position where it covers the connection release tool 7. Thereby, the pair of chuck claws of the connection release tool 7 can be closed together by the external pressure of the inner sheath 4, and the proximal end connecting portion 10 of the clip unit 8 can be chucked in a state of being held. In this state, the four-pronged arm portion 11 of the clip unit 8 is still open.

Next, the proximal portion of the outer sheath 5 of the ligation device 1 beyond the grip portion 5a is inserted into the channel of the endoscope, but when the four-pronged arm portion 11 is open, it is inserted into the channel of the endoscope. Since this is not possible, hold the knob 5a at the proximal end of the outer sheath 5 and move it forward so that the distal end of the outer sheath 5 covers the outside of the clip unit 8, as shown in FIG. 6(D). As a result, the four-pronged arm portion 11 is narrowed and the clip unit 8 is housed within the distal end portion of the outer sheath 5.

Next, the ligating device 1 is advanced to a position where the insertion portion of the endoscope inserted into the channel of the endoscope is as close as necessary to the affected area in the digestive tract in the state shown in FIG. 6(D), and further, the outer sheath 5 is The clip unit 8 covered with the clip unit 8 is advanced to the vicinity of the affected area in the digestive tract, and then, as shown in FIG. While keeping the finger ring 2c covered, the outer sheath 5 is pulled back to a position where it does not cover the four-pronged arm part 11 of the clip unit 8 by pinching the knob 5a of the outer sheath 5. As a result, the four-pronged arm portion 11 is opened by the force of restoring the animal and is opposed to a position close to the affected area within the digestive tract.

Next, as shown in FIG. 9(A), the first and second arm legs 12 and 13, which are slightly opened, are advanced so as to sandwich one wall of the affected area and come into contact with each other, and then, as shown in FIG. 9(B) As shown in , by operating the slider 2b of the operating part 2 to move forward relative to the cylinder shaft part 2a and moving the inner sheath 4 by a required distance in the forward direction, the tightening ring at the initial fitted position A is moved. 30 is moved to the first tightening position B where the first widened portions 12b, 13b of the first and second arm legs 12, 13 are tightened. As a result, the first clamping parts 12c and 13c of the first and second arm legs 12 and 13 are brought into a state in which they close together and clamp one wall of the affected area. At this time, the claws 16 and 17 at the tips of the first and second arm legs 12 and 13 dig into one wall from both sides, so that one wall of the affected area can slip and escape from the first clamping parts 12c and 13c. There is no.

Next, for example, by tilting the axis of the clip unit 8, one wall of the affected area held by the first holding parts 12c, 13c is moved closer to the other wall, as shown in FIG. 9(C). The first and second arm legs 12 , 13 and the third and fourth arm legs 14 , 15 are integral with each other and open independently from their base ends, depending on the tightening position of the tightening ring 30 . Since the structure is tightened, when the first and second arm legs 12 and 13 are closed, the open state of the third and fourth arm legs 14 and 15 does not become narrowed.

Next, in order to close the third and fourth arm legs 14 and 15 that are wide open, the slider 2b of the operating section 2 shown in FIG. 1 is operated to further retreat relative to the cylinder shaft section 2a, and the inner sheath is 4 is further moved forward by the required dimension. As a result, as shown in FIG. 8(A), the tightening ring 30 is moved through the intermediate position where the second widened portions 14b and 15b of the third and fourth arm legs 14 and 15 are tightened, and then further moved to a second clamping position. It is possible to move to a second tightening position C where parts 14c and 15c are tightened. As a result, as shown in FIG. 9(D), the claws 18 and 19 dig into both sides of the affected area, and the second clamping parts 14c and 15c grip the both sides of the affected area so that they are brought together. This allows the walls of a wide open wound to be closed together. If both walls of the wound are kept closed for a certain period of time, tissue can bond between the walls of the wound.

After the treatment is completed, the clip unit 8 is placed in the body cavity. Therefore, after the treatment is completed, the inner sheath 4 is connected as shown in FIG. 8(B) by moving the knob portion 5a of the operating portion 2 shown in FIG. It moves relatively to a position where it does not cover the release tool 7. As a result, the connection release tool 7 elastically returns to the open state and is released from the chuck. Next, the ligation device 1 is separated from the clip unit 8 by pulling the finger ring 2c in the proximal direction, so the clip unit 8 is placed in the state shown in FIGS. 4(D), 5(D), and 9(D). It can be placed in a body cavity.

As explained above, the clip unit for a ligation device according to the present invention has two pairs of first to fourth arm legs 12-15 that can be opened and closed, and the clamping ring can be moved in two stages. It has a four-pronged structure that allows the pair of first to fourth arm legs 12 to 15 to be closed in stages one by one, and the pair of first and second arm legs 12 and 13 can be used to close a wide open wound (affected area). It is possible to grasp one wall surface, bring one wall surface close to the other wall surface, and then bring both sides of the paired hole wall, which are joined by another pair of third and fourth arm legs 14 and 15, to the paired hole wall. It is possible to provide a clip unit 8 for a ligation device that can be placed in a body cavity while reliably closing a wound. Further, by combining press working and laser welding, it is possible to provide a clip unit 8 for a ligation device that is easy to manufacture and does not have deterioration in spring opening/closing performance.

1... Ligation device 2... Operation part 2a... Cylindrical shaft part 2a1... Slit 2b... Slider 2b1... Diameter connection part 2b2... Finger hook part 2c... Finger hook ring 3a... Male type cylindrical connection part 3b... Female type cylindrical connection part 4 ...Inner sheath 4a...Inner sheath main body 4b...Holding cylinder 4b1...Tightening ring housing part 4b2...Chuck constriction part 5...Outer sheath 5a...Knob part 6...Operation wire 7...Connection release tool 7a, 7b...Chuck claw 8...Ligation Clip unit for device 8a...Clip unit main body 10...Proximal end connecting portion 10a...End surface portion 10b, 10b...Side surface portion 11...Four-pronged arm portion 12...First arm leg 12a...Proximal end portion 12b...First widening portion ( slanted widening part)
12c...first clamping part (tip part)
13...Second arm leg 13a...Base end portion 13b...First widening part (slanted widening part)
13c...first clamping part (tip part)
14...Third arm leg 14a...Base end part 14b...Second widening part 14c...Second clamping part (tip part)
15... Fourth arm leg 15a... Base end part 15b... Second widening part 15c... Second clamping part (tip part)
16, 17...Claw 18, 19...Claw 20a, 20b...Protrusion 30...Tightening ring A...Initial fitted position B...First tightening position C...Second tightening position

Claims (6)

A clip unit for a ligation device that is separably provided at the tip of a ligation device that is inserted through the channel of an endoscope and inserted into the body cavity of a living body to grasp the affected area and stop bleeding, etc., and is separated and left in the body after the procedure. And,
Each arm has a proximal end connecting part chucked by a uncoupling tool connected to a distal end of an operating wire of the ligation device, and first to fourth arm legs extending integrally from the proximal end connecting part. It has a four-pronged arm portion having a claw at the tip of the leg, and a tightening ring that is fitted onto the proximal end side of the four-pronged arm portion and is provided so as to be slidable in the distal direction by operation of the ligation device,
The four-pronged arm part has a bifurcated shape that starts to widen from the middle and has a predetermined gap at the tip, and the first and second arm legs that increase the stock return force in the closing direction, and the first and second arm legs. The third and fourth arm legs are bifurcated and have tips that begin to widen from the middle of the tip side and are separated by a required distance from the first and second arm legs to increase the stock return force in the closing direction. including;
The base end of the first arm leg and the base end of the third arm leg are side by side, and the base end of the second arm leg and the base end of the fourth arm leg are side by side. and a fitted state in which the four corners of the cross section of the base end portions of the first to fourth arm legs are in contact with the inner circumferential surface is defined as an initial fitted position;
When the tightening ring moves from the initial fitted position to a first tightening position separated by a predetermined distance in the distal direction, the distal end portions of the first and second arm legs close together, and the tightening ring further closes together. A clip for a ligation device, characterized in that the clamping ring is configured such that the distal end portions of the first to fourth arm legs are closed together when the clamping ring is moved to a second clamping position separated by a predetermined distance in the distal direction. unit. The first and second arm legs extend integrally from the proximal end connecting portion and have a proximal end portion that is the initial fitted position of the tightening ring, and a midway portion that extends at an angle toward the end. and a first clamping portion that is a distal end portion and extends substantially parallel to each other;
The third and fourth arm legs extend integrally from the proximal end connecting portion and have a proximal end portion that is the initial fitted position of the tightening ring, and a midway portion that is curved and extends toward the tip. 2. The ligature according to claim 1, wherein the ligature includes a second widening portion located at the tip of the ligature, and a second clamping portion that is a distal end portion and has a predetermined crossing angle so as to gradually open toward the distal end. Clip unit for equipment. When the tightening ring moves from the initial fitted position to the first tightening position which is a required distance apart in the distal direction, the tightening ring moves to the first tightening position at a midway portion between the first and second arm legs. When the widening portion is tightened to close the first clamping portion, which is the distal end portion, and the tightening ring is further moved to a second tightening position separated by a required distance in the distal direction, the tightening ring After tightening the second widening part of the middle part of the third and fourth arm legs, the second clamping part which is the tip part is tightened, and the second clamping of the third and fourth arm legs is performed. The clip unit for a ligating device according to claim 2, wherein the clip unit has a structure in which the parts are closed together. The pair of claws provided at the tips of the first and second arm legs are oriented toward the center of opening and closing, and are arranged to overlap front and back when the tips of the first and second arm legs are closed together. and
The pair of claws provided at the tips of the third and fourth arm legs are oriented toward the center of opening and closing, and are arranged to overlap front and back when the tips of the first and second arm legs are closed. The clip unit for a ligation device according to claim 1, which has a configuration in which: A portion near each tip of the first and second arm legs and each claw extending from each tip are formed to be wide and extend on the opposite side in the plate width direction from the third and fourth arm legs. ,
A portion near each tip of the third and fourth arm legs and each claw extending from each tip are formed wide so as to extend on the opposite side in the board width direction from the first and second arm legs. A clip unit for a ligation device according to any one of claims 1 to 4. The four-pronged arm portion has an initial fitting position where the tightening ring is fitted to the proximal end sides of the first to fourth arm legs, and a first clamping position of the pair of the first and second arm legs. the first tightening position of the tightening ring when the parts are closed together; and the tightening position when the second clamping parts of the pair of third and fourth arm legs of the tightening ring are closed together. Claim 1: At each of the second tightening positions of the attachment ring, the tightening ring has a plurality of protrusions that can be climbed over and abutted against the tightening ring to prevent movement toward the proximal end. 5. The clip unit for a ligation device according to any one of items 4 to 4.

Images