JP7633940B2 - ENDOSCOPE CLIP SYSTEM AND METHOD FOR MANUFACTURING SAME - Google Patents

Description

The present invention relates to an endoscopic clip system used for purposes such as hemostasis in surgery or treatment using an endoscope, and a method for manufacturing an endoscopic clip system.

Treatments using endoscopes, such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR), can sometimes cause bleeding during the procedure. One method of stopping bleeding in such cases is the clipping method, in which an endoscopic treatment tool with a clip attached is used to place a clip at the bleeding site and apply pressure to stop the bleeding.

For example, Patent Document 1 describes a clip having a main body with a pair of arms and a fastening member that is inserted into the main body and can fasten and close the arms, with each arm forming a fastening receiver, and the outer periphery of the fastening receiver in at least one arm being formed into a curved surface that is convex in the opposite direction to the other arm. Patent Document 2 describes a ligation device for biological tissue that includes a clip having arms that grasp biological tissue, a fastening member that closes the arms, a connecting member that engages with the clip, and an engaging portion that restricts the movement of the connecting member relative to the fastening member. Patent Document 3 describes an endoscopic clip device in which a clip is connected to an operation motion transmission member that is arranged in a flexible sheath and can be moved forward and backward, and the clip is held in a closed state by pulling the operation motion transmission member from the operating portion connected to the flexible sheath, and a water supply channel that penetrates the axial direction is formed over the entire length of the operation motion transmission member, and both ends of the water supply channel are opened straight in the axial direction. Patent document 4 describes an endoscopic clip device in which a clip and a clip closing ring that maintains the arms in a closed state are positioned near the tip of the sheath, and a friction surface that prevents the base end connecting portion of the clip from slipping out of the clip closing ring is provided at the contact surface between the base end connecting portion of the clip and the clip closing ring.

JP 2011-78592 A JP 2009-11852 A JP 2004-254887 A JP 2002-360585 A

In conventional endoscopic clip systems such as those disclosed in Patent Documents 1 to 4, the clip connector of the endoscopic treatment tool is inserted distally into an opening at the proximal end of the clip, and the clip is attached to the clip connector. In addition, some conventional endoscopic clip systems have directional properties at the proximal end of the clip and the distal end of the clip connector to prevent the clip from rotating relative to the clip connector. Therefore, in conventional endoscopic clip systems, when attaching a clip to the clip connector, it is necessary to insert the clip connector into the opening at the proximal end of the clip while checking the orientation of the clip and the clip connector, which can take time to attach the clip. In clinical settings, rapid treatment of bleeding is required, so there is a demand for reliable attachment of clips to endoscopic clip systems.

The present invention has been made in consideration of the above circumstances, and its object is to provide an endoscopic clip system that allows for easy attachment of medical clips, and a method for manufacturing the same.

The endoscopic clip system that has been able to solve the above problem includes a medical clip that grasps an object, and a linear object having a distal end and a proximal end, extending along a longitudinal axis, and moving the medical clip along the longitudinal axis, the linear object having a clip connecting portion that connects the medical clip to the surgeon's side, the medical clip having a longitudinal direction, a direction in which the medical clip opens and closes, and a width direction of the medical clip, the medical clip being disposed opposite each other and including a first arm portion and a second arm portion that grasp the object. and a first base and a second base arranged opposite each other and located proximal to the first arm and second arm, the medical clip is configured to be connected to the clip connecting portion at the first base and the second base, the medical clip has a connecting portion at a first end side in the width direction that connects the first base and the second base, and the medical clip and the clip connecting portion are connected by fitting the clip connecting portion between the first base and the second base of the medical clip from the second end side in the width direction of the medical clip.

It is preferable that, at the proximal end of the medical clip of the endoscopic clip system of the present invention, the arithmetic mean roughness Ra based on JIS B0601 of the inner surface of the medical clip is greater than the arithmetic mean roughness Ra based on JIS B0601 of the outer surface of the medical clip.

In the endoscopic clip system of the present invention, it is preferable that the medical clip does not require any force to position the clip connecting portion from the second end side of the medical clip in the width direction between the first base and the second base of the medical clip.

In the clip system for endoscope of the present invention, it is preferable that a protrusion is provided on the inner surface of the medical clip at the second end side in the width direction of the medical clip.

In the endoscopic clip system of the present invention, it is preferable that at least one of the first base portion and the second base portion and the clip connecting portion have an engaging portion that engages the clip connecting portion with the medical clip.

In the endoscopic clip system of the present invention, it is preferable that the connection portion is located proximal to the midpoint of the longitudinal length of the medical clip.

In the endoscopic clip system of the present invention, it is preferable that the distal end of the clip connection portion is located distal to the proximal end of the connection portion.

In the endoscopic clip system of the present invention, the medical clip further has a cylindrical fastening ring arranged on the outside of the first base and the second base, the fastening ring being movable longitudinally on the medical clip, and when the medical clip is not gripping an object, the fastening ring is arranged at the distal end of its range of motion, and the clip connecting portion is moved proximally, it is preferable that the force required for the clip connecting portion to detach from the medical clip is 20 N or more.

In the endoscopic clip system of the present invention, it is preferable that the linear object further has a pusher capable of moving in the longitudinal direction, and that the distal end of the pusher is configured to contact the proximal end of the fastening ring and move the fastening ring distally.

In the endoscopic clip system of the present invention, it is preferable that the clip connection portion has a contact portion that contacts the proximal end of the medical clip.

In the endoscopic clip system of the present invention, the medical clip further has a first claw portion at the proximal end of the first base portion extending toward the second base portion, and a second claw portion at the proximal end of the second base portion extending toward the first base portion, and it is preferable that the first claw portion and the second claw portion have a notch along the outer periphery of the linear object.

In the endoscopic clip system of the present invention, it is preferable that the clip connecting portion has a groove portion that is concave in the circumferential direction of the clip connecting portion, and that the distal wall surface of the groove portion contacts the distal side surface of the proximal end of the medical clip, and that the proximal wall surface of the groove portion contacts the proximal side surface of the proximal end of the medical clip.

The manufacturing method of the endoscopic clip system that has been able to solve the above-mentioned problems includes a medical clip that grasps an object, and a linear object having a distal end and a proximal end, extending along a longitudinal axis and moving the medical clip along the longitudinal axis, the linear object having a clip connecting portion that connects the medical clips, the medical clip having a longitudinal direction, an opening and closing direction of the medical clip, and a width direction of the medical clip, the medical clip has first and second arms that are arranged opposite each other and grasp the object, and first and second bases that are arranged opposite each other and are proximal to the first and second arms, the medical clip is configured to connect to the clip connecting portion at the first and second bases, a connecting portion that connects the first and second bases is provided at a first end side in the width direction of the medical clip, and the manufacturing method includes a step of fitting the clip connecting portion between the first and second bases of the medical clip from the second end side in the width direction of the medical clip.

According to the endoscopic clip system of the present invention, the medical clip has a first base and a second base, and a connection portion on the first end side of the medical clip in the width direction, and the medical clip can be attached to the clip connection portion by fitting the clip connection portion between the first base and the second base of the medical clip from the second end side of the medical clip in the width direction, making it easier to attach the medical clip than with conventional endoscopic clip systems. Also, according to the manufacturing method of the endoscopic clip system of the present invention, the medical clip has a connection portion on the first end side of the width direction, and includes a step of fitting the clip connection portion between the first base and the second base from the second end side of the width direction of the medical clip, making it easier to attach the medical clip to the clip connection portion than with conventional endoscopic clip systems.

1 illustrates a plan view of the distal side of an endoscopic clip system in one embodiment of the present invention. 2 is a cross-sectional view of the clip system for an endoscope shown in FIG. 1 along line II-II. 2 shows a plan view of the distal side of the linear member of the endoscopic clip system shown in FIG. 1 . 2 is a plan view of a medical clip of the endoscopic clip system shown in FIG. 1 , without showing a fastening ring; 5 shows a cross-sectional view of the medical clip shown in FIG. 4 taken along the line VV. 13 illustrates a cross-sectional view of a proximal end of a medical clip of an endoscopic clip system in accordance with another embodiment of the present invention. 13 is a plan view of a medical clip without a fastening ring according to another embodiment of the present invention; FIG. 13 is a plan view of the distal side of a linear object of an endoscopic clip system in accordance with another embodiment of the present invention. FIG. 13 is a plan view of the distal side of a linear object of a clip system for an endoscope in yet another embodiment of the present invention. FIG.

The present invention will be described in more detail below based on the following embodiments, but the present invention is not limited to the following embodiments and can of course be modified as appropriate within the scope of the above and below, all of which are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, reference should be made to the specification or other drawings. Furthermore, the dimensions of various components in the drawings may differ from the actual dimensions, as priority is given to contributing to an understanding of the features of the present invention.

Figure 1 is a plan view of the distal side of an endoscopic clip system 1 in one embodiment of the present invention, and Figure 2 is a cross-sectional view perpendicular to the longitudinal direction of the endoscopic clip system 1.

1 and 2, the endoscopic clip system 1 of the present invention includes a medical clip 10 that grips an object, and a linear object 20 that has a distal end and a proximal end, extends in the longitudinal direction, and moves the medical clip 10 along its longitudinal axis. After gripping the target site inside the body, the medical clip 10 is separated from the linear object 20 at the connecting portion, and the linear object 20 is removed from the body.

In the present invention, the proximal side refers to the side of the user's hand in the extension direction of the linear object 20, and the distal side refers to the opposite side of the proximal side, i.e., the side to be treated. The extension direction of the linear object 20 is also referred to as the longitudinal direction. The longitudinal direction can be rephrased as the direction of approach to the linear object 20. The radial direction refers to the radial direction of the circumscribing circle of the cross-sectional shape of the linear object 20 in the longitudinal direction, the inward radial direction refers to the direction toward the axial center of the circumscribing circle of the cross-sectional shape of the linear object 20, and the outward radial direction refers to the direction toward the opposite side to the inward. In addition, in Figures 1, 3, and 4, the right side of the figure is the proximal side, and the left side of the figure is the distal side.

The medical clip 10 is attached to the linear object 20 of the endoscopic clip system 1 during endoscopic treatments such as ESD and EMR, and is used for stopping bleeding, suturing lesions, etc.

Examples of materials that make up the medical clip 10 include stainless steels such as SUS301, SUS303, SUS304, and SUS631, Ni-Ti alloys, and the like. Of these, it is preferable that the material that makes up the medical clip 10 is stainless steel. By using stainless steel as the material that makes up the medical clip 10, the medical clip 10 becomes highly elastic and the biocompatibility of the medical clip 10 can be improved.

The linear object 20 has a longitudinal direction. That is, the linear object 20 extends along the longitudinal axis. The linear object 20 may be tubular having an inner cavity extending along the longitudinal axis, but is preferably solid. By making the linear object 20 solid, the rigidity of the linear object 20 can be increased without increasing the outer diameter of the linear object 20. As a result, the insertability of the endoscopic clip system 1 can be improved. The linear object 20 may be a single wire or a twisted wire in which single wires are twisted together. If the linear object 20 is a single wire, it is easy to manufacture. If the linear object 20 is a twisted wire, the strength of the linear object 20 can be increased, so that the operation on the hand side is easily transmitted to the distal end including the medical clip 10 and the clip connecting portion 21. The cross-sectional shape of the wire constituting the linear object 20 may be, for example, a circular shape, an elliptical shape, a polygonal shape, or a combination of these shapes.

Examples of materials constituting the linear object 20 include metals such as stainless steels such as SUS301, SUS303, SUS304, and SUS631, and carbon steel, as well as synthetic resin fibers such as polyamide resins such as nylon, polyolefin resins such as PP and PE, polyester resins such as PET, aromatic polyether ketone resins such as PEEK, polyimide resins, and fluororesins such as PTFE, PFA, and ETFE. Among these, it is preferable that the material constituting the linear object 20 is stainless steel. By using stainless steel as the material constituting the linear object 20, it is possible to improve biocompatibility while providing the strength required for the endoscopic clip system 1.

Although not shown, the linear object 20 may have a coating layer on its surface. By having the linear object 20 have a coating layer, it is possible to reduce friction on the surface of the linear object 20 and increase the sliding properties, and to increase the strength of the linear object 20. Examples of the coating layer include fluororesins such as PTFE, PFA, ETFE, and tetrafluoroethylene-hexafluoropropylene copolymer (FEP).

A method for forming a coating layer on the linear object 20 can be, for example, to coat the linear object 20 with a material for forming the coating layer, and methods such as a dipping method, a spraying method, a fluidized bed method, or a kneader coater method can be used.

The longitudinal length of the linear object 20 can be appropriately selected taking into consideration the distance from the forceps port of the endoscope to the area to be treated, and can be, for example, 1000 mm or more and 3000 mm or less. In addition, by providing a handle on the proximal side of the linear object 20, the medical clip 10 and the linear object 20 can be easily operated.

The outer diameter of the linear object 20 is preferably 100 μm or more, more preferably 200 μm or more, and even more preferably 300 μm or more. By setting the lower limit of the outer diameter of the linear object 20 within the above range, the rigidity of the linear object 20 can be increased. Furthermore, the outer diameter of the linear object 20 is preferably 900 μm or less, more preferably 800 μm or less, and even more preferably 700 μm or less. By setting the upper limit of the outer diameter of the linear object 20 within the above range, the linear object 20 can be made thinner, and the insertability of the endoscopic clip system 1 can be improved.

The outer diameter of the linear object 20 may be the same over its entire length or may vary. For example, the proximal portion of the linear object 20 may be made thicker for reinforcement. Methods for reinforcing the linear object 20 include, for example, placing a tubular part on the outer surface of the linear object 20.

Figure 3 is a plan view of the distal side of the linear object 20 of the endoscopic clip system 1. As shown in Figure 3, the linear object 20 has a clip connecting portion 21 that connects the medical clip 10 to the distal side. The medical clip 10 can be attached to the linear object 20 by connecting the medical clip 10 to the clip connecting portion 21. In other words, the linear object 20 has a distal end and a proximal end, extends along a longitudinal axis, and moves the medical clip 10 along the longitudinal axis.

The clip connecting part 21 is provided on the linear object 20. For the operation of the medical clip 10, the clip connecting part 21 is provided on the distal side of the linear object 20, and is preferably provided on the distal end of the linear object 20. The linear object 20 preferably has a portion having an outer diameter that increases toward the distal side as the clip connecting part 21. The clip connecting part 21 may be a part of the linear object 20, or may be configured by attaching a separate part (hereinafter sometimes referred to as a "clip connecting part") for connecting the medical clip 10 to the linear object 20. The clip connecting part 21 may be disposed, for example, on the distal end of the linear object 20.

When the clip connection part 21 is a clip connection part attached to the linear object 20, the material of the clip connection part may be, for example, a metal such as stainless steel or carbon steel, a polyamide resin such as nylon, a polyolefin resin such as PP or PE, a polyester resin such as PET, an aromatic polyether ketone resin such as PEEK, a polyimide resin, or a synthetic resin such as fluororesin such as PTFE, PFA, or ETFE. Among them, it is preferable that the material of the clip connection part is the same as the material of the linear object 20. By using the same material of the clip connection part as the material of the linear object 20, the connection between the clip connection part and the linear object 20 can be made strong, so that the clip connection part is less likely to come off from the linear object 20. As a result, the durability of the endoscopic clip system 1 can be increased.

When the clip connecting portion 21 is a clip connecting component, the method of fixing the clip connecting component to the linear object 20 can be, for example, mechanical fixing using a connecting member such as a screw, crimping, fitting, or press-fitting, welding using a laser, silver solder, or heat, or adhesion using an adhesive or tape. Among these, it is preferable that the clip connecting component is fixed to the linear object 20 by welding. By fixing the clip connecting component to the linear object 20 by welding, the bonding strength between the clip connecting component and the linear object 20 can be increased.

Figure 4 is a plan view of the medical clip 10, and Figure 5 is a cross-sectional view perpendicular to the longitudinal direction of the medical clip 10. As shown in Figures 4 and 5, the medical clip 10 has a first part 11 and a second part 12 arranged opposite each other. The first part 11 has a first arm 11a on the distal side and a first base 11b located proximal to the first arm 11a. Similarly, the second part 12 has a second arm 12a on the distal side and a second base 12b located proximal to the second arm 12a. For example, as shown in Figure 4, the distal side of the midpoint P1 of the longitudinal length of the medical clip 10 can be the arm, and the proximal side can be the base. The medical clip 10 has a longitudinal direction, an opening and closing direction of the medical clip 10, and a width direction of the medical clip 10. The medical clip 10 is configured to connect to the clip connecting part 21 on the proximal side in the longitudinal direction of the medical clip 10, and to grasp an object on the distal side in the longitudinal direction. A connecting part 13 that connects the first base 11b and the second base 12b is disposed on the first end side in the width direction of the medical clip 10, and the medical clip 10 and the clip connecting part 21 are connected by fitting the clip connecting part 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10.

In conventional endoscopic clip systems, as described above, the proximal end of the medical clip has an opening through which the clip connector is inserted, and the medical clip is attached to the clip connector by inserting the clip connector into this opening toward the distal side while checking the orientation of the medical clip and the clip connector. The opening at the proximal end of the medical clip is very small because it opens in the longitudinal direction. Since the opening of the medical clip is small, if the position of the clip connector is misaligned when inserting it into the opening, it becomes difficult to insert the clip connector into the opening. Therefore, accurate positioning of the opening of the medical clip and the clip connector is required. In clip systems that have restrictions on the connection direction between the medical clip and the clip connector, if the orientation of the medical clip and the clip connector is incorrect, the medical clip cannot be attached to the clip connector, or the medical clip is easily detached from the clip connector.

On the other hand, in the endoscopic clip system 1 of the present invention, the medical clip 10 has a first part 11 and a second part 12, and the connection part 13 is arranged on the first end side of the width direction of the medical clip 10. The medical clip 10 can be attached to the clip connection part 21 by fitting the clip connection part 21 between the first base part 11b and the second base part 12b of the medical clip 10 from the second end side of the width direction of the medical clip 10. In other words, since the medical clip 10 is not connected from the longitudinal direction of the conventional medical clip 10 but is approached from a direction perpendicular to the longitudinal direction, the endoscopic clip system 1 of the present invention can attach the medical clip 10 more easily than the conventional endoscopic clip system. Since the cross-sectional area of the external shape of the medical clip 10 in the direction perpendicular to the longitudinal direction is larger than the cross-sectional area of the external shape of the medical clip 10 in the longitudinal direction, the opening can be made larger according to the present invention. In addition, when attaching the medical clip 10, there is no need to check the orientation of the medical clip 10 and the clip connecting portion 21, and the medical clip 10 can be attached to the clip connecting portion 21 by fitting the clip connecting portion 21 between the first base portion 11b and the second base portion 12b of the medical clip 10 from a direction perpendicular to the longitudinal direction of the medical clip 10, which has an opening area larger than the opening at the proximal end of the medical clip 10, so that the endoscopic clip system 1 of the present invention can attach the medical clip 10 more easily than the conventional endoscopic clip system. In Fig. 4, the left-right direction of the paper corresponds to the longitudinal direction, the up-down direction of the paper corresponds to the opening and closing direction of the medical clip 10, and the front-back direction of the paper corresponds to the width direction of the medical clip 10. In three-dimensional coordinates, when the x-axis direction is the longitudinal direction, the y-axis direction can be the opening and closing direction, and the z-axis direction can be the width direction. The medical clip 10 is configured to be connected to the clip connecting portion 21 of the linear object 20 on the proximal side in the longitudinal direction thereof, and to grip an object on the distal side in the longitudinal direction thereof.

It is preferable that the force required to fit the clip connecting portion 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10 is 0.05N or more. By setting the lower limit of the force required to fit the clip connecting portion 21 between the first base 11b and the second base 12b from the second end side to the above range, it is possible to reliably confirm whether the medical clip 10 is attached to the clip connecting portion 21 by the tactile feeling when the clip connecting portion 21 is pushed into the medical clip 10 and fitted. Therefore, it is possible to prevent the medical clip 10 from being unintentionally removed by using the endoscopic clip system 1 for treatment when the medical clip 10 is not sufficiently attached to the clip connecting portion 21. The upper limit of the force required to fit the clip connecting portion 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10 is not particularly limited, but can be, for example, 10N or less. In addition, except when the force required to fit the clip connecting portion 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side of the width direction of the medical clip 10 is not generated, a sense of resistance is generated when fitting, so that the attachment of the clip connecting portion 21 to the medical clip 10 can be recognized by touch.

6 shows a cross-sectional view of the proximal end of the medical clip 10 of the endoscopic clip system 1 in another embodiment of the present invention. Specifically, it shows a cross-sectional view perpendicular to the longitudinal direction of the endoscopic clip system 1 at the portion where the connection portion 13 of the medical clip 10 is arranged. As shown in FIG. 6, the medical clip 10 may have a protrusion 60 on the inner surface of the medical clip 10 at the second end side in the width direction of the medical clip 10. The protrusion 60 can be a soft protrusion-like object provided on one or both ends of the first base 11b or the second base 12b on the second end side, which is the opposite side to the first end side where the connection portion 13 is located. When the clip connecting portion 21 is fitted between the first base 11b and the second base 12b of the medical clip 10, the clip connecting portion 21 touches the protrusion 60, causing a sense of resistance, and this tactile sensation allows the user to reliably recognize whether the medical clip 10 is attached to the clip connecting portion 21. Furthermore, by providing the protrusion 60, it is possible to prevent the clip connecting portion 21 from moving toward the second end side and becoming detached from the medical clip 10.

The protrusion 60 may serve as a guide for guiding the clip connecting portion 21 from the second end side to the first end side of the medical clip 10. For example, the shape of the protrusion 60 may be a right triangle with one end side as the base in a cross section perpendicular to the longitudinal axis of the medical clip 10, and the clip connecting portion 21 may be fitted between the first part 11 and the second part 12 along the hypotenuse.

The medical clip 10 may be configured such that no force is generated when the clip connecting portion 21 is fitted between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10. In the embodiment of the present invention, the fact that no force is generated to place the clip connecting portion 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10 includes that the force required to place the clip connecting portion 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10 is less than 0.05 N. In this case, in order to connect the medical clip 10 and the clip connecting portion 21, it is preferable to provide engagement portions 71, 72, and 73 on the first base 11b or the second base 12b of the medical clip 10 and the clip connecting portion 21.

7 shows a plan view of the medical clip 10 without the fastening ring 30 of the endoscopic clip system 1 in another embodiment of the present invention, FIG. 8 shows a plan view of an example of the distal end of the linear object 20, and FIG. 9 shows a plan view of another example of the distal end of the linear object 20. As shown in FIG. 7, at least one of the first base 11b and the second base 12b and the clip connecting part 21 preferably has engaging parts 71, 72, 73 that engage the clip connecting part 21 and the medical clip 10. The engaging parts 71, 72, 73 can be, for example, interlocking grooves, irregularities, etc. The engaging parts 71, 72, 73 may be a combination of a large diameter part and a small diameter part provided on the medical clip 10 and the clip connecting part 21. The large diameter part on the distal side comes into contact with the small diameter part, so that the two engage with each other, and the connection between the medical clip 10 and the clip connecting part 21 can be strengthened. Incidentally, even in a mode in which a force is generated when the medical clip 10 and the clip connecting portion 21 are engaged with each other, the engaging portions 71, 72, and 73 can be provided.

Examples of the embodiment of the engaging portions 71, 72, and 73 include the following. As shown in FIG. 7, a groove as the engaging portion 71 can be provided on one or both of the first base portion 11b and the second base portion 12b of the medical clip 10, and as shown in FIG. 8 and FIG. 9, the clip connecting portion 21 can be provided with convex portions as the engaging portions 72 and 73 that engage with the groove as the engaging portion 71 of the medical clip 10. In addition, when the cross section perpendicular to the longitudinal direction of the clip connecting portion 21 is circular, the engaging portions 72 and 73 can be provided as convex portions that engage with the groove of the engaging portion 71 of the medical clip 10 over a part or the entire circumference of the clip connecting portion 21. Alternatively, when the cross section perpendicular to the longitudinal direction of the clip connecting portion 21 is rectangular, the engaging portions 72 and 73 can be provided as convex portions that engage with the groove that is the engaging portion 71 of the medical clip 10 over a part or the entire circumference of the clip connecting portion 21.

The medical clip 10 may be formed, for example, by bending a single metal plate including the first portion 11, the second portion 12, and the connecting portion 13, or may be formed by joining a part including the first portion 11, a part including the second portion 12, and a part including the connecting portion 13. In particular, it is preferable that the medical clip 10 is formed by bending a single metal plate including the first portion 11, the second portion 12, and the connecting portion 13. By forming the medical clip 10 from a single metal plate, there is less variation in the product during the manufacture of the medical clip 10, and the manufacturing efficiency of the medical clip 10 can be improved.

When the medical clip 10 is formed by joining together a part including the first part 11, a part including the second part 12, and a part including the connecting part 13, the part including the connecting part 13 and the part including the first part 11 and the part including the second part 12 can be joined by, for example, mechanical fixation using a connecting member such as a screw, crimping, fitting, or press-fitting, welding using a laser, silver solder, or heat, or adhesion using an adhesive or tape. Among these, the part including the connecting part 13 and the part including the first part 11 and the part including the second part 12 are preferably joined by welding. By joining the parts by welding, the joining strength of the parts can be increased.

It is preferable that the length from the distal end 13d of the connecting portion 13 to the proximal end 13p of the connecting portion 13 is greater than at least one of the width of the proximal end of the first portion 11 and the width of the proximal end of the second portion 12. Since the length from the distal end 13d of the connecting portion 13 to the proximal end 13p is greater than at least one of the width of the proximal end of the first portion 11 and the width of the proximal end of the second portion 12, the connecting portion 13 can easily prevent the distance between the first portion 11 and the second portion 12 from changing, and for example, when the clip connecting portion 21 is fitted between the first portion 11 and the second portion 12, the distance between the first portion 11 and the second portion 12 can be prevented from widening, causing the clip connecting portion 21 to come off the medical clip 10.

4, the connection portion 13 is preferably located proximal to the midpoint P1 of the longitudinal length of the medical clip 10. By locating the connection portion 13 proximal to the midpoint P1 of the longitudinal length of the medical clip 10, the clip connecting portion 21 can be easily fitted to the medical clip 10 and is less likely to come off, thereby improving the ease of handling of the endoscopic clip system 1.

It is more preferable that the connection portion 13 is located proximal to the midpoint P1 of the longitudinal length of the medical clip 10 and distal to the proximal end of the medical clip 10. By arranging the connection portion 13 proximal to the midpoint P1 of the longitudinal length of the medical clip 10 and distal to the proximal end of the medical clip 10, the medical clip 10 is less likely to be deformed or damaged due to being opened widely.

At the proximal end of the medical clip 10, it is preferable that the arithmetic mean roughness Ra of the inner surface of the medical clip 10 based on JIS B0601 is greater than the arithmetic mean roughness Ra of the outer surface of the medical clip 10 based on JIS B0601. By making the arithmetic mean roughness Ra of the inner surface at the proximal end of the medical clip 10 greater than the arithmetic mean roughness Ra of the outer surface, the friction force between the inner surface of the medical clip 10 and the outer surface of the clip connecting part 21 can be increased. As a result, the medical clip 10 is less likely to rotate in the circumferential direction relative to the clip connecting part 21, making the endoscopic clip system 1 easier to handle.

1, when the medical clip 10 and the clip connecting part 21 are connected, it is preferable that the distal end 21d of the clip connecting part 21 is disposed distal to the proximal end 13p of the connecting part 13. By disposing the distal end 21d of the clip connecting part 21 distal to the proximal end 13p of the connecting part 13, the contact area between the inner surface of the medical clip 10 and the outer surface of the clip connecting part 21 can be made sufficient. Therefore, during a procedure using the endoscopic clip system 1 after the medical clip 10 is attached to the clip connecting part 21, it is possible to prevent the medical clip 10 from unintentionally falling off the clip connecting part 21.

The distal end 21d of the clip connecting part 21 is disposed distally of the proximal end 13p of the connecting part 13, and more preferably, the proximal end of the clip connecting part 21 is disposed proximally of the proximal end 13p of the connecting part 13. In addition to the distal end 21d of the clip connecting part 21 being disposed distally of the proximal end 13p of the connecting part 13, the proximal end of the clip connecting part 21 being disposed proximally of the proximal end 13p of the connecting part 13, the area of contact between the inner surface of the medical clip 10 and the outer surface of the clip connecting part 21 can be further increased. As a result, the frictional force generated between the inner surface of the medical clip 10 and the outer surface of the clip connecting part 21 can be increased, making it difficult for the medical clip 10 to fall off the clip connecting part 21.

1, the endoscopic clip 10 further has a cylindrical fastening ring 30 disposed on the outside of the first base 11b and the second base 12b, that is, on the outer periphery of the medical clip 10, and the fastening ring 30 is movable in the longitudinal direction on the medical clip 10. When the medical clip 10 is not gripping an object, the fastening ring 30 is disposed at the most distal position of the range of motion of the fastening ring 30, and the clip connector 21 is moved proximally, the force required for the clip connector 21 to be detached from the medical clip 10 is preferably 20 N or more. Since the force required for the clip connector 21 to be detached from the medical clip 10 when the clip connector 21 is moved proximally is 20 N or more, it is necessary to apply a certain amount of force to detach the medical clip 10 from the clip connector 21, and therefore the medical clip 10 is prevented from being unintentionally detached during use of the endoscopic clip system 1, and treatment can be performed smoothly.

When the medical clip 10 is not gripping an object, the fastening ring 30 is placed at the most distal position of the range of motion of the fastening ring 30, and the clip connector 21 is moved proximally, the force required for the clip connector 21 to detach from the medical clip 10 can be appropriately set depending on the application of the medical clip 10. It is preferable that the force required for the clip connector 21 to detach from the medical clip 10 is set to be greater than the force required to move the fastening ring 30. This setting is to prevent the medical clip 10 from detaching from the clip connector 21 when the fastening ring 30 is moved. For example, it is preferable that the force required for the clip connector 21 to detach from the medical clip 10 is 20 N or more. By setting the lower limit of the force required for the clip connector 21 to be detached from the medical clip 10 when the clip connector 21 is moved proximally within the above range, the medical clip 10 is less likely to be unintentionally detached from the clip connector 21, and time loss such as reattaching the medical clip 10 to the clip connector 21 during treatment using the endoscopic clip system 1 is less likely to occur. In addition, when the fastening ring 30 is placed at the most distal position of the range of motion of the fastening ring 30 and the clip connector 21 is moved proximally while the medical clip 10 is not gripping an object, if the force required for the clip connector 21 to be detached from the medical clip 10 is too small, the medical clip 10 will easily detach from the clip connector 21, which is not preferable. In addition, if this force is too large, it will be difficult to separate the medical clip 10 and the clip connector 21. By appropriately setting the force required for the clip connecting portion 21 to detach from the medical clip 10 when the clip connecting portion 21 is moved proximally, it becomes easier to detach the medical clip 10 from the clip connecting portion 21 after the medical clip 10 has grasped the bleeding area, etc., and treatment using the endoscopic clip system 1 can be performed smoothly.

The material of the fastening ring 30 may be the same as that of the medical clip 10, for example, stainless steels such as SUS301, SUS303, SUS304, and SUS631, and metals such as Ni-Ti alloys. In particular, it is preferable that the material of the fastening ring 30 contains stainless steel. By containing stainless steel in the material of the fastening ring 30, a highly elastic fastening ring 30 can be obtained. Therefore, the fastening ring 30 can easily press the medical clip 10 from the outside, making it easier to close the medical clip 10.

As shown in FIG. 1, the linear object 20 further has a pusher 40 capable of moving in the longitudinal direction, and the distal end 40d of the pusher 40 is preferably configured to contact the proximal end 30p of the fastening ring 30 to move the fastening ring 30 distally. By having the pusher 40 on the linear object 20, it becomes easier to move the fastening ring 30 distally, and it also becomes easier to close the medical clip 10 and grasp the object. The pusher 40 is preferably operated by an operating handle disposed on the proximal side of the linear object 20. When the pusher 40 is operated by the operating handle, the linear object 20 and the pusher 40 are preferably integrated via the operating handle.

It is preferable that the pushing tool 40 is tubular and the linear object 20 is disposed in the inner cavity of the pushing tool 40. By disposing the linear object 20 in the inner cavity of the pushing tool 40, the pushing tool 40 can be moved along the linear object 20, making it easier to move the pushing tool 40 in the longitudinal direction. The pushing tool 40 pushes the fastening ring 30 to move it from the proximal side to the distal side of the medical clip 10. Therefore, it is preferable that the distal end of the pushing tool 40 is tubular with a cross-sectional size that is the same as or similar to that of the fastening ring 30.

Examples of materials for the pressing tool 40 include stainless steel such as SUS304 and SUS316, metals such as platinum, nickel, cobalt, chromium, titanium, tungsten, gold, Ni-Ti alloys, and Co-Cr alloys, polyamide resins such as nylon, polyolefin resins such as polyethylene and polypropylene, polyester resins such as polyethylene terephthalate (PET), aromatic polyether ketone resins such as polyether ether ketone (PEEK), polyimide resins, and synthetic resins such as polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), and ethylene-tetrafluoroethylene copolymer (ETFE). Among these, the material for the pressing tool 40 is preferably a metal, and more preferably contains stainless steel. Since the material of the pressing tool 40 is metal, the pressing tool 40 is less likely to be crushed when the distal end 40d of the pressing tool 40 comes into contact with the proximal end 30p of the fastening ring 30, and the force applied to the pressing tool 40 is sufficiently transmitted to the fastening ring 30, making it easier to move the fastening ring 30 distally.

Although not shown, the distal end of the pushing tool 40 is preferably a coil. By having the distal end of the pushing tool 40 be a coil, the distal end of the pushing tool 40 is easily bent. Therefore, even if the distal end of the endoscopic clip system 1 is curved when the medical clip 10 is gripped on an object, the fastening ring 30 can be easily moved distally by the pushing tool 40.

1 and 3, the clip connecting portion 21 preferably has a contact portion 22 that contacts the proximal end 10p of the medical clip 10. By having the clip connecting portion 21 have the contact portion 22, the contact portion 22 contacts the proximal end 10p of the medical clip 10, thereby preventing longitudinal movement of the linear object 20, and making it difficult for the medical clip 10 to come off the clip connecting portion 21 in unintended circumstances.

4 and 5, the medical clip 10 further has a first claw portion 51 extending toward the second base portion 12b at the proximal end of the first base portion 11b, and a second claw portion 52 extending toward the first base portion 11b at the proximal end of the second base portion 12b, and as shown in FIG. 2, the first claw portion 51 and the second claw portion 52 preferably have a notch 53 along the outer periphery of the linear object 20. The medical clip 10 has the first claw portion 51 and the second claw portion 52, which prevents the linear object 20 from moving proximally relative to the medical clip 10 and prevents the medical clip 10 from unintentionally coming off the linear object 20. Furthermore, since the first claw portion 51 and the second claw portion 52 have a notch 53 that follows the outer periphery of the linear object 20, when attaching the medical clip 10 to the linear object 20, even if the medical clip 10 has the first claw portion 51 and the second claw portion 52 at the proximal ends of the first base portion 11b and the second base portion 12b, the linear object 20 passes through the notch 53, making it easier to attach the medical clip 10 to the linear object 20.

When the gripping of the object by the medical clip 10 is completed and the medical clip 10 is to be removed from the linear object 20 to retain the medical clip 10, it is preferable that the clip connecting part 21 pushes the first claw part 51 and the second claw part 52 from the distal side toward the proximal side to deform them, so that the clip connecting part 21 passes through the notch 53, and the clip connecting part 21 moves to the proximal side to remove the medical clip 10 from the linear object 20. The clip connecting part 21 deforms the first claw part 51 and the second claw part 52 to pass through the notch 53, and the medical clip 10 is removed from the linear object 20. As a result, the clip connecting part 21 does not move to the proximal side unless a force greater than the deformation of the first claw part 51 and the second claw part 52 is applied to the clip connecting part 21, and the medical clip 10 can be prevented from being unintentionally removed from the linear object 20.

The first claw portion 51 may be formed by bending the proximal end of the first part 11, or may be formed by joining a part constituting the first claw portion 51 (hereinafter, sometimes referred to as the "first claw part") to the proximal end of the first part 11. Similarly, the second claw portion 52 may be formed by bending the proximal end of the second part 12, or may be formed by joining a part constituting the second claw portion 52 (hereinafter, sometimes referred to as the "second claw part") to the proximal end of the second part 12. Among them, it is preferable that the first claw portion 51 is formed by bending the proximal end of the first part 11, and the second claw portion 52 is formed by bending the proximal end of the second part 12. Since the first claw portion 51 is formed by bending the proximal end of the first part 11 and the second claw portion 52 is formed by bending the proximal end of the second part 12, the first claw portion 51 is prevented from coming off the first part 11 and the second claw portion 52 is prevented from coming off the second part 12. Even if a load is applied to the first claw portion 51 and the second claw portion 52 when attaching the medical clip 10 to the clip connecting part 21 or removing the medical clip 10 from the clip connecting part 21, the first claw portion 51 and the second claw portion 52 of the medical clip 10 are less likely to be damaged.

When the first claw portion 51 is formed by joining the first claw portion part to the first base portion 11b, and the second claw portion 52 is formed by joining the second claw portion part to the second base portion 12b, the first claw portion part and the second claw portion part can be joined to the first base portion 11b and the second base portion 12b, respectively, by, for example, mechanical fixing using a connecting member such as a screw, crimping, fitting, or press-fitting, welding using a laser or heat, or adhesion using an adhesive or tape. Among them, the method of joining the first claw portion part and the second claw portion part to the first base portion 11b and the second base portion 12b, respectively, is preferably welding. By joining each part by welding, it is possible to increase the joining strength of the first claw portion part to the first base portion 11b and the joining strength of the second claw portion part to the second base portion 12b.

1 and 3, the clip connecting portion 21 has a groove portion 23 that is recessed in the circumferential direction of the clip connecting portion 21, and it is preferable that the distal side wall surface 24d of the groove portion 23 contacts the distal side surface of the proximal end of the medical clip 10, and the proximal side wall surface 24p of the groove portion 23 contacts the proximal side surface of the proximal end of the medical clip 10. Since the distal side wall surface 24d of the groove portion 23 contacts the distal side surface of the proximal end of the medical clip 10 and the proximal side wall surface 24p of the groove portion 23 contacts the proximal side surface of the proximal end of the medical clip 10, the proximal end of the medical clip 10 is fitted into the groove portion 23 of the clip connecting portion 21, so that the medical clip 10 is firmly fixed to the clip connecting portion 21, and the medical clip 10 is less likely to fall off unintentionally when the endoscopic clip system 1 is used.

It is preferable that the depth of the groove 23 is greater than the thickness of the first claw 51 and the second claw 52. The depth of the groove 23 indicates the size of the groove 23 in the radial direction of the clip connecting part 21, the thickness of the first claw 51 indicates the size of the first claw 51 in the longitudinal direction, and the thickness of the second claw 52 indicates the size of the second claw 52 in the longitudinal direction. Since the depth of the groove 23 is greater than the thickness of the first claw 51 and the second claw 52, it becomes easier to fit the clip connecting part 21 into the medical clip 10 from the second end side in the width direction of the medical clip 10, and the medical clip 10 can be easily attached to the clip connecting part 21.

Although not shown, it is preferable that the endoscopic clip system 1 has a handle connected to the proximal end of the linear object 20. The handle is a member that is gripped by the user when operating the endoscopic clip system 1. Having a handle in the endoscopic clip system 1 makes it easier to operate the endoscopic clip system 1.

The manufacturing method of the endoscopic clip system 1 of the present invention includes a medical clip 10 that grasps an object, and a linear object 20 that has a distal end and a proximal end, extends along a longitudinal axis, and moves the medical clip 10 along the longitudinal axis, the linear object 20 having a clip connecting portion 21 that connects the medical clip 10 to the distal side, the medical clip 10 having a longitudinal direction, an opening and closing direction of the medical clip 10, and a width direction of the medical clip 10, the medical clip 10 being disposed opposite each other and having a first arm 11a and a second arm 12 that grasp the object. a and a first base 11b and a second base 12b disposed opposite each other and located proximal to the first arm 11a and the second arm 12a, the medical clip 10 is configured to be connected to a clip connecting portion 21 at the first base 11b and the second base 12b, the medical clip 10 has a connecting portion 13 connecting the first base 11b and the second base 12b at a first end side in the width direction of the medical clip 10, and includes a step of fitting the clip connecting portion 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10. Note that in the following description of the manufacturing method of the endoscopic clip system 1, descriptions of parts that overlap with the description of the above-mentioned endoscopic clip system 1 will be omitted.

The manufacturing method of the endoscopic clip system 1 includes a step of fitting the clip connecting part 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10. By pushing the clip connecting part 21 between the first base 11b and the second base 12b of the medical clip 10 from the second end side in the width direction of the medical clip 10, the medical clip 10 can be easily attached to the clip connecting part 21.

As described above, the endoscopic clip system of the present invention includes a medical clip that grasps an object, and a linear object having a distal end and a proximal end, extending along a longitudinal axis, and moving the medical clip along the longitudinal axis, the linear object having a clip connecting portion that connects the medical clip to the distal side, the medical clip having a longitudinal direction, an opening and closing direction of the medical clip, and a width direction of the medical clip, the medical clip being disposed opposite each other and including a first arm portion and a second arm portion that grasp the object. The medical clip has a first portion and a second portion disposed opposite each other and located proximal to the first arm and the second arm, the medical clip is configured to be connected to the clip connector at the first base and the second base, the medical clip has a connection portion connecting the first base and the second base at a first end in the width direction, and the medical clip and the clip connector are connected by fitting the clip connector between the first base and the second base of the medical clip from the second end in the width direction of the medical clip. The medical clip has a first portion and a second portion, and the connection portion is disposed at the first end in the width direction of the medical clip, and the medical clip can be attached to the clip connector by fitting the clip connector between the first base and the second base of the medical clip from the second end in the width direction of the medical clip, making it easier to attach the medical clip than conventional endoscopic clip systems.

In addition, the manufacturing method of the endoscopic clip system of the present invention includes a medical clip that grasps an object, and a linear object having a distal end and a proximal end, extending along a longitudinal axis, and moving the medical clip along the longitudinal axis, the linear object having a clip connecting portion that connects the medical clip to the distal side, the medical clip having a longitudinal direction, an opening and closing direction of the medical clip, and a width direction of the medical clip, the medical clip being disposed opposite each other, and having a first arm portion and a second arm portion that grasp the object. and a first base and a second base disposed opposite each other and located proximal to the first arm and the second arm, the medical clip is configured to be connected to the clip connecting portion on the proximal side in the longitudinal direction of the medical clip and to grasp an object on the distal side in the longitudinal direction, the medical clip has a connecting portion connecting the first base and the second base at a first end side in the width direction, and includes a step of fitting the clip connecting portion between the first base and the second base of the medical clip from the second end side in the width direction of the medical clip. By arranging the connecting portion at the first end side in the width direction of the medical clip and including a step of pushing the clip connecting portion between the first base and the second base from the second end side in the width direction of the medical clip, the medical clip can be more easily attached to the clip connecting portion than in conventional endoscopic clip systems.

This application claims the benefit of priority based on Japanese Patent Application No. 2019-208964, filed on November 19, 2019. The entire contents of the specification of Japanese Patent Application No. 2019-208964, filed on November 19, 2019, are incorporated by reference into this application.

1: endoscopic clip system 10: medical clip 10p: proximal end of medical clip 11: first part 11a: first arm 11b: first base 12: second part 12a: second arm 12b: second base 13: connection part 13d: distal end of connection part 13p: proximal end of connection part 20: linear object 21: clip connecting part 21d: distal end of clip connecting part 22: contact part 23: groove 24d: distal wall surface of groove 24p: proximal wall surface of groove 30: fastening ring 30p: proximal end of fastening ring 40: pusher 40d: distal end of pusher 51: first claw part 52: second claw part 53: notch 60: protrusion 71: engagement part 72: engagement part 73: engagement part P1: Midpoint of the longitudinal length of the medical clip

Claims (11)

A medical clip for gripping an object;
a wire having a distal end and a proximal end, extending along a longitudinal axis, for moving the medical clip along the longitudinal axis;
the linear object has a clip connecting portion for connecting the medical clip to a distal side thereof,
the medical clip has a longitudinal direction, an opening and closing direction of the medical clip, and a width direction of the medical clip;
The medical clip has a first arm and a second arm arranged opposite each other and configured to grip the object, and a first base and a second base arranged opposite each other and located proximal to the first arm and the second arm,
the medical clip is configured to couple to the clip connector at the first base and the second base;
the medical clip has a connection portion at a first end side in a width direction, the connection portion connecting the first base portion and the second base portion,
a protrusion is provided on an inner surface of the medical clip and on a proximal end of the medical clip at a second end side in a width direction of the medical clip ;
An endoscopic clip system in which the medical clip and the clip connecting portion are connected by fitting the clip connecting portion between the first base portion and the second base portion of the medical clip from a second end side in the width direction of the medical clip. The endoscopic clip system according to claim 1, wherein the arithmetic mean roughness Ra based on JIS B0601 of the inner surface of the medical clip is greater than the arithmetic mean roughness Ra based on JIS B0601 of the outer surface of the medical clip at the proximal end of the medical clip. The clip system for an endoscope according to claim 1 or 2, wherein at least one of the first base and the second base, and the clip connecting part, includes an engagement part that engages the clip connecting part with the medical clip. The clip system for endoscopes according to any one of claims 1 to 3, wherein the connection portion is disposed proximal to the midpoint of the longitudinal length of the medical clip. The clip system for an endoscope according to any one of claims 1 to 4, wherein the distal end of the clip connecting portion is disposed distal to the proximal end of the connecting portion. The medical clip further includes a cylindrical fastening ring disposed outside the first base portion and the second base portion,
the fastening ring is longitudinally movable on the medical clip;
The clip system for an endoscope according to any one of claims 1 to 5, wherein when the fastening ring is positioned at the distal end of its range of motion and the clip connecting portion is moved proximally while the medical clip is not gripping an object, a force required for the clip connecting portion to detach from the medical clip is 20 N or more. The linear object further has a pusher that is movable in a longitudinal direction,
The clip system for an endoscope according to claim 6 , wherein a distal end of the pusher is configured to contact a proximal end of the fastening ring to move the fastening ring distally. The clip system for endoscopes according to any one of claims 1 to 7, wherein the clip connecting portion has a contact portion that contacts the proximal end of the medical clip. The medical clip further includes a first claw portion at a proximal end of the first base portion and extending toward the second base portion,
a second prong portion at a proximal end of the second base portion extending toward the first base portion;
The clip system for an endoscope according to any one of claims 1 to 8, wherein the first claw portion and the second claw portion have a notch along an outer periphery of the linear object. The clip connecting portion has a groove portion that is recessed in a circumferential direction of the clip connecting portion,
a distal wall surface of the groove contacts a distal side surface of a proximal end of the medical clip;
The clip system for an endoscope according to any one of claims 1 to 9, wherein the proximal wall surface of the groove is in contact with the proximal side surface of the proximal end of the medical clip. A medical clip for gripping an object;
a wire having a distal end and a proximal end, extending along a longitudinal axis, for moving the medical clip along the longitudinal axis;
the linear object has a clip connecting portion for connecting the medical clip to a distal side thereof,
the medical clip has a longitudinal direction, an opening and closing direction of the medical clip, and a width direction of the medical clip;
The medical clip has a first arm and a second arm arranged opposite each other and configured to grip the object, and a first base and a second base arranged opposite each other and located proximal to the first arm and the second arm,
the medical clip is configured to couple to the clip connector at the first base and the second base;
a connecting portion that connects the first base portion and the second base portion to a first end side in a width direction of the medical clip;
a protrusion is provided on an inner surface of the medical clip and on a proximal end of the medical clip at a second end side in a width direction of the medical clip ;
A manufacturing method for an endoscopic clip system, comprising a step of fitting the clip connecting portion between the first base portion and the second base portion of the medical clip from a second end side in the width direction of the medical clip.

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