Medical Clip System
The medical clip system addresses connection stability issues by using a bridge configuration and a shorter ring, facilitating easy attachment and preventing broken necks, ensuring effective delivery and release.
Patent Information
- Application Number
- JP2022036708
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2022-03-09
- Publication Date
- 2026-02-04
- Estimated Expiration
- 2042-03-09
AI Technical Summary
Existing medical clip systems face difficulties in easily connecting a linear object to the clip and maintaining a stable connection, leading to issues such as broken necks that prevent delivery and clipping.
A medical clip system with a bridge connecting the base portions of the clip, reducing the space for the connecting portion from the base end to the tip, and a ring with a shorter axial length, allowing easy and stable connection of a linear object.
Enables easy and stable connection of the clip to the linear object, preventing broken necks and ensuring delivery to the treatment site, with easy release of the connection when needed.
Smart Images

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Abstract
Description
[Technical Field]
[0001] The present invention relates to a medical clip system used for treatments such as hemostasis in endoscopic surgery. [Background technology]
[0002] Endoscopic procedures such as endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) can sometimes result in bleeding during the procedure. One method for stopping such bleeding or bleeding from lesions in body cavities such as the digestive tract is the clipping method, which uses an endoscopic treatment tool equipped with a medical clip to place the medical clip at the bleeding site and apply pressure to stop the bleeding.
[0003] In the clipping method, a clip system with a medical clip attached to the tip of a linear object is inserted into the forceps channel through the forceps port of the endoscope, and the medical clip is then transported to the treatment site. Multiple medical clips are often used in a single procedure, and a new clip must be attached to the clip system each time clipping with one clip is completed.
[0004] For example, Patent Document 1 discloses a tissue clipping device in which a clip having a bulbous proximal end is removably connected to a control wire. Patent Document 2 discloses a device in which a clip is connected to a tension cable by a rear crosspiece that connects the two legs of the clip, allowing for the installation of multiple hemostatic clips. Patent Document 3 discloses a clip cartridge in which, when the operating wire is pushed forward, the tip connector advances relative to the tubular sleeve of the clip, establishing a connected state in which the tip connector and the locking portion of the clip are connected. Patent Document 4 discloses a clip system that simplifies clip attachment by fitting the clip connector between the first and second bases of the medical clip from the second end side in the width direction of the medical clip. [Prior art documents] [Patent documents]
[0005] [Patent Document 1] Japanese Patent Application Publication No. 2017-202335 [Patent Document 2] Japanese Patent Application Laid-Open No. 2011-143262 [Patent Document 3] Japanese Patent Application Publication No. 2017-148182 [Patent Document 4] International Publication No. 2021 / 100378 Summary of the Invention [Problem to be solved by the invention]
[0006] The medical clip systems disclosed in Patent Documents 1 and 2 have a configuration in which two arms of the clip are connected at their base ends, and a linear object such as a wire is hooked onto this connected part to connect them. Such a configuration poses a problem in that it is difficult to easily connect linear objects. Furthermore, in the medical clip system disclosed in Patent Document 3, the wire is pushed into the clip from the base end side, and in the medical clip system disclosed in Patent Document 4, the clip connecting part is fitted into the clip from the second end side. However, even in these medical clip systems, there is room for improvement in easily attaching a linear object to the medical clip and stably maintaining the state in which the linear object is attached to the clip.
[0007] The present invention has been made in consideration of the above circumstances, and aims to provide a medical clip system that can easily connect a linear object to a medical clip and can stably maintain the connected state between the linear object and the medical clip. [Means for solving the problem]
[0008] One embodiment of the medical clip system of the present invention that can solve the above problems is a medical clip system comprising: a medical clip having a first part and a second part opposed to each other and configured to grasp biological tissue; a ring having an inner cavity into which the medical clip is inserted; and a linear object having a connecting part that is connected to the medical clip; wherein the medical clip has a base end and a tip end, and has an opening / closing direction, an axial direction from the base end to the tip end, and a width direction perpendicular to the opening / closing direction and the axial direction; the first part has a first arm portion that grasps the biological tissue and a first base portion located closer to the base end than the first arm portion; the second part has a second arm portion that grasps the biological tissue and a second base portion located closer to the base end than the second arm portion; and the medical clip has a first end side and a second end side in the width direction; The medical clip has a bridge on the first end side connecting the first base portion and the second base portion, the medical clip has a section in which the distance between the first base portion and the second base portion in the opening and closing direction decreases from the base end to the tip, and thereby has a reduced section in which the space for receiving the connecting portion decreases from the base end to the tip, the bridge is located closer to the tip than the base end and closer to the base end than the first arm portion and the second arm portion in the axial direction, the reduced section is located closer to the tip than the base end end of the bridge in the axial direction, the first base portion and the second base portion are not connected except via the bridge, and the axial length of the ring is shorter than the axial length from the base end of the medical clip to the tip end of the bridge.
[0009] In the medical clip system, the medical clip has a bridge connecting the first base and the second base at the first end in the width direction, the bridge being located distal to the proximal end and proximal to the first and second arms, the first base and the second base being connected only via the bridge, and the axial length of the ring being shorter than the axial length from the proximal end of the medical clip to the distal end of the bridge, thereby enabling the linked portion of the linear object to be easily and stably linked to the medical clip. Furthermore, the distance between the first and second bases in the opening and closing direction has a section that decreases from the proximal end to the distal end, thereby providing a reduced section in which the space for receiving the linked portion decreases from the proximal end to the distal end. The reduced section is located distal to the proximal end of the bridge, thereby stably restraining the linked portion of the linear object to the proximal end of the clip, thereby preventing the distal end of the linked portion of the linear object from coming off the clip and causing a broken neck. A broken neck state is a state in which the clip hangs from the distal end of the linear object, preventing the clip and the linear object from being coaxially aligned. In this state, it becomes impossible to deliver the clip to the treatment site or clip it, but the medical clip system having the above configuration can prevent such problems. Furthermore, because it is the contraction section that constrains the connecting portion, when removing the clip from the linear object, the connection between the clip and the connecting portion can be easily released by pulling the linear object proximally in the axial direction. In this way, the above medical clip system can easily and stably connect the clip and the linear object, and can prevent the tip side of the connecting portion of the linear object from coming off the clip when the clip and the linear object are connected, causing a broken neck, and also makes it easy to release the connection between the clip and the linear object.
[0010] In the axial direction, it is preferable that a point P at which the distance between the first base portion and the second base portion in the opening / closing direction is shortest is located closer to the tip than the tip end of the bridge.
[0011] It is preferable that the medical clip and the linear object are connected by fitting the connecting portion between the first base portion and the second base portion from the second end side in the width direction.
[0012] When the medical clip and the linear object are connected, it is preferable that the distal end of the connecting portion is located further distal than the proximal end of the bridge in the axial direction.
[0013] The connecting portion preferably has a contact portion that contacts the base end of the medical clip.
[0014] The medical clip preferably further includes a first claw portion protruding from a base end of the first base toward the second base, and a second claw portion protruding from a base end of the second base toward the first base. In this case, the first claw portion and the second claw portion preferably have notches along the outer periphery of the linear object. [Effects of the Invention]
[0015] The above medical clip system allows for easy and stable connection between the clip and the linear object, and prevents the distal end of the connecting portion of the linear object from coming off the clip when the clip and the linear object are connected, resulting in a broken neck. A broken neck occurs when the clip hangs from the distal end of the linear object, preventing the clip and the linear object from being aligned on the same axis. In this state, the clip cannot be delivered to the treatment site or clipped, but the medical clip system having the above configuration can prevent such problems. Furthermore, the above medical clip system also makes it easy to release the connection between the clip and the connecting portion. [Brief explanation of the drawings]
[0016] [Figure 1] 1 illustrates a plan view of a medical clip system according to an embodiment of the present invention. [Figure 2] 2 shows a cross-sectional view of the medical clip system shown in FIG. 1 along line II-II. [Figure 3] 1 illustrates a plan view of a medical clip system when a medical clip and a linear object are connected in one embodiment of the present invention. [Figure 4] 10 is a plan view of a medical clip system when a medical clip and a linear object are connected together in another embodiment of the present invention. FIG. [Figure 5] 5 shows a VV cross-sectional view of the medical clip system shown in FIG. 4. [Figure 6] 5 shows a plan view of the distal side of the linear object shown in FIG. 4. DETAILED DESCRIPTION OF THE INVENTION
[0017] The present invention will be described below based on the embodiments, but the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.
[0018] An embodiment of the medical clip system of the present invention will be described with reference to FIGS. 1 to 6. However, the present invention is not limited to the embodiment shown in the drawings. FIG. 1 is a plan view of a medical clip system 1 according to one embodiment of the present invention, illustrating a state in which a medical clip 10 and a linear object 20 are not connected. In FIG. 1, the inner tube 25 and a portion of the linear object 20 are disposed within the outer tube 26, and therefore are indicated by dotted lines. FIG. 2 is a cross-sectional view taken along the II-II line of FIG. 1, i.e., a cross-sectional view perpendicular to the axial direction x at a location where the bridge 13 is disposed on the medical clip 10. FIGS. 3 and 4 are plan views of the medical clip system 1 according to another embodiment, illustrating a state in which the medical clip 10 and the linear object 20 are connected. In FIGS. 3 and 4, the bridge 13, the inner tube 25, and a portion of the linear object 20 are disposed below other components, and therefore are indicated by dotted lines. Fig. 5 shows a VV cross-sectional view of the medical clip system 1 shown in Fig. 4, and shows a cross-sectional view of the first claw portion 110 and the second claw portion 120 provided at the clip base end 10b. Fig. 6 shows a plan view of the distal side of the linear object 20 shown in Fig. 4.
[0019] As shown in Figure 1, a medical clip system 1 according to an embodiment of the present invention comprises a medical clip 10 having a first part 11 and a second part 12 facing each other and configured to grasp biological tissue, a ring 30 having an inner cavity into which the medical clip 10 is inserted, and a linear object 20 having a connecting part 22 connected to the medical clip 10.
[0020] The medical clip 10 has a base end 10b and a tip end 10a, an opening / closing direction y, an axial direction x extending from the base end 10b to the tip end 10a, and a width direction z perpendicular to the opening / closing direction y and the axial direction x. In this specification, members and parts other than the medical clip 10 will also be described as having the same axial direction x, opening / closing direction y, and width direction z as the medical clip 10. The side of the tip end 10a in the axial direction x may be described as the distal side, and the opposite side as the proximal side. In FIG. 1, the left side of the figure is the distal side, and the right side is the proximal side. The proximal side is the extension direction of the linear object 20, i.e., the side closer to the user in the axial direction x, and the distal side is the opposite side of the proximal side, i.e., the side facing the treatment object.
[0021] In this specification, the medical clip system 1 may be simply referred to as the clip system 1, and the medical clip 10 may be simply referred to as the clip 10. The base end 10b of the medical clip 10 may also be referred to as the clip base end 10b, and the tip 10a of the medical clip 10 may also be referred to as the clip tip end 10a.
[0022] When connecting a linear object 20 to a medical clip 10, the linear object 20 is positioned so that the connecting portion 22 of the linear object 20 is on the distal side, thereby allowing the connecting portion 22 of the linear object 20 to be connected to the base end 10B of the medical clip 10 (hereinafter also referred to as the clip base end 10B). Here, the clip base end 10B refers to the portion including the clip base end 10b. The medical clip system 1, in which the medical clip 10 is connected to the distal side of the linear object 20, is passed through the forceps channel of an endoscope, and the medical clip 10 is transported to the site to be treated, whereby clipping with the clip 10 can be performed inside the patient's body.
[0023] The linear object 20 is a member extending in the axial direction x and can be composed of one or more members. The linear object 20 may be solid or hollow with an inner lumen extending along the axial direction x, but is preferably solid. The solid shape of the linear object 20 increases the rigidity of the linear object 20 without increasing the outer diameter of the linear object 20. As a result, the insertion ability of the medical clip system 1 can be improved. The linear object 20 may be a solid wire or a twisted wire formed by twisting together single wires. If the linear object 20 is a solid wire, manufacturing is easier. If the linear object 20 is a twisted wire, the strength of the linear object 20 can be increased, making it easier to transmit a proximal operation to the distal portion of the medical clip system 1, including the medical clip 10 and the connecting portion 22. The cross-sectional shape of the linear object 20 can be, for example, a circle, an ellipse, a polygon, or a combination thereof.
[0024] Examples of materials constituting the linear object 20 include metals such as stainless steels such as SUS301, SUS303, SUS304, and SUS631, and carbon steel; polyamide resins such as nylon; polyolefin resins such as PP and PE; polyester resins such as PET, and aromatic polyether ketone resins such as PEEK; polyimide resins; and synthetic resin fibers such as fluororesins such as PTFE, PFA, and ETFE. Among these, stainless steel is preferred as the material constituting the linear object 20. By making the linear object 20 out of stainless steel, the strength of the linear object 20 can be ensured while improving biocompatibility.
[0025] Although not shown, the linear object 20 may have a coating layer on its surface. Examples of the coating layer include fluororesins such as PTFE, PFA, ETFE, and tetrafluoroethylene-hexafluoropropylene copolymer (FEP). By having the coating layer on the linear object 20, it is possible to reduce friction on the surface of the linear object 20, thereby increasing the slidability and increasing the strength of the linear object 20.
[0026] The method for forming a coating layer on the linear object 20 should be such that the material forming the coating layer covers the surface of the linear object 20, and for example, a dipping method, a spraying method, a fluidized bed method, a kneader coater method, etc. can be used.
[0027] The length of the linear object 20 in the axial direction x can be selected appropriately taking into consideration the distance from the forceps port of the endoscope to the treatment target area, and can be, for example, 1000 mm or more and 3000 mm or less.
[0028] 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. When the lower limit of the outer diameter of the linear object 20 is 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. When the upper limit of the outer diameter of the linear object 20 is within the above range, the insertability of the clip system 1 can be improved.
[0029] The outer diameter of the linear object 20 may be the same or may vary over the entire length in the axial direction x. For example, the proximal portion of the linear object 20 may be thickened for reinforcement. Examples of methods for reinforcing the linear object 20 include disposing a tubular part on the outer surface of the linear object 20.
[0030] As shown in FIG. 1 , the linear object 20 has a connecting portion 22 on the distal side that connects to the medical clip 10. The medical clip 10 can be attached to the linear object 20 by connecting the medical clip 10 to the connecting portion 22. The linear object 20 preferably has a configuration in which the outer diameter of the connecting portion 22 is larger than the outer diameter of the portion other than the connecting portion 22. This stabilizes the connection between the connecting portion 22 and the medical clip 10. The connecting portion 22 may be formed integrally with the linear object 20, or the linear object 20 may be composed of a linear object main body 21 and the connecting portion 22 which is a separate member, and the connecting portion 22 may be attached to the distal side of the linear object main body 21.
[0031] The shape of the connecting portion 22 is not particularly limited as long as it can be connected to the clip base end 10B, but the cross-sectional shape of the connecting portion 22 perpendicular to the axial direction x can be, for example, circular, elliptical, polygonal, or a combination of these.
[0032] When the connecting portion 22 is attached to the linear object main body 21 as a separate member, the above description of the material constituting the linear object 20 can be referred to for the materials constituting the linear object main body 21 and the connecting portion 22. Even when the connecting portion 22 is attached to the linear object main body 21 as a separate member, it is preferable that the material of the connecting portion 22 is the same as the material of the linear object main body 21. By making the material of the connecting portion 22 the same as the material of the linear object main body 21, the connection between the connecting portion 22 and the linear object main body 21 can be strengthened, making it difficult for the connecting portion 22 to come off the linear object main body 21. As a result, the durability of the medical clip system 1 can be improved.
[0033] When the connecting portion 22 is a separate member, the connecting portion 22 and the linear object main body 21 can be fixed to each other by, for example, mechanical fixing such as screws, crimping, fitting, press-fitting, etc.; fusion; welding; adhesion using adhesives, tape, etc. Among these, it is preferable that the connecting portion 22 is fixed to the linear object main body 21 by welding. This can increase the bonding strength between the connecting portion 22 and the linear object main body 21.
[0034] As shown in FIG. 1 , it is preferable that at least a portion of the linear object 20 is disposed within the inner tube 25. That is, it is preferable that the medical clip system 1 further includes an inner tube 25, and that the linear object 20 is disposed within the lumen of the inner tube 25. With the clip 10 connected to the linear object 20, the opening and closing of the clip 10 can be adjusted by moving the linear object 20 proximally or distally in the axial direction x of the inner tube 25. For example, when the linear object 20 is moved proximally relative to the inner tube 25, the proximal end of the ring 30 comes into contact with the distal end of the inner tube 25, and the clip 10 can be closed by moving the ring 30 toward the clip tip 10a.
[0035] It is preferable that the inner tube 25 has both flexibility to bend along the shape of the inside of the body cavity and rigidity to reliably reach the treatment target site. The inner tube 25 can be composed of a coil body made of metal or synthetic resin, a cylindrical body in which multiple short cylindrical joint pieces are connected in the axial direction to enable rotation, a cylindrical body made of synthetic resin, or a combination of these. For the types of metals and synthetic resins, please refer to the above explanation of the material that makes up the linear object 20.
[0036] The medical clip system 1 may further include an outer tube 26. In this case, the inner tube 25 is disposed in the inner cavity of the outer tube 26. It is preferable that the clip 10 be configured to be freely inserted and removed from the outer tube 26 when connected to the linear object 20. By storing the clip 10 within the outer tube 26, the clip 10 can be prevented from being exposed. This prevents the clip 10 from damaging the forceps channel or internal tissue other than the lesion while transporting the clip 10 to the treatment site. During treatment, the clip 10 and the ring 30 are exposed from the outer tube 26.
[0037] It is desirable that the outer cylinder 26 has flexibility and rigidity similar to the inner cylinder 25. The outer cylinder 26 can be composed of a cylindrical body made of synthetic resin, a coil body made of metal or synthetic resin, a cylindrical body in which multiple short cylindrical joint links are connected in the axial direction to enable rotation, or a combination of these. Among these, a cylindrical body made of synthetic resin is preferably used for the outer cylinder 26. For the types of synthetic resin, refer to the above explanation of the material making up the linear object 20. The outer cylinder 26 may be composed of a transparent or translucent material to make it easier to check the positional relationship between the outer cylinder 26 and the inner cylinder 25.
[0038] The first portion 11 of the medical clip 10 has a first arm 11a for grasping biological tissue and a first base portion 11b located closer to the clip base end 10b than the first arm 11a. The second portion 12 of the medical clip 10 has a second arm 12a for grasping biological tissue and a second base portion 12b located closer to the clip base end 10b than the second arm 12a. For example, as shown in FIG. 1 , the arm portion can be located closer to the clip tip 10a than the midpoint M of the length of the axial direction x of the medical clip 10, and the base portion can be located closer to the clip base end 10b than the midpoint M. In the natural state of the clip 10, the distance between the first arm 11a and the second arm 12a in the opening / closing direction y preferably increases from the clip base end 10b toward the clip tip 10a. This allows biological tissue to be positioned between the first arm 11a and the second arm 12a.
[0039] Examples of materials that can be used to form the first and second parts 11 and 12 of the medical clip 10 include Ni-Ti alloys and stainless steels such as SUS301, SUS303, SUS304, and SUS601. Among these, stainless steel is preferred as the material that forms the medical clip 10. If the medical clip 10 is made of stainless steel, the medical clip 10 will have high elasticity and the biocompatibility of the medical clip 10 can be improved.
[0040] 1 and 2, the medical clip 10 has a first end side and a second end side in the width direction z, and has a bridge 13 on the first end side connecting the first base portion 11b and the second base portion 12b. The bridge 13 is located closer to the clip distal end 10a than the clip proximal end 10b and closer to the clip proximal end 10b than the first arm portion 11a and the second arm portion 12a. The bridge 13 being located closer to the clip distal end 10a than the clip proximal end 10b means that the first portion 11 and the second portion 12, which are formed as a continuous member, are not bent at the clip proximal end 10b to form two arms, but rather the first portion 11 and the second portion 12, which are independent of each other, are connected by the bridge 13 on the clip distal end 10a side of the clip proximal end 10b. Furthermore, because the bridge 13 is located closer to the clip base end 10b than the first arm 11a and the second arm 12a, the bridge 13 can directly connect the first base 11b and the second base 12b. This allows the bridge 13 to be configured so that it does not interfere with the first arm 11a and the second arm 12a grasping biological tissue. Furthermore, the first base 11b and the second base 12b are not connected except via the bridge 13. That is, the first portion 11 and the second portion 12 are not connected except via the bridge 13, and a gap is formed between the first portion 11 and the second portion 12 at the clip base end 10b. An example of a bridge 13 that enables such a configuration includes a bridge-like configuration that directly connects the first base 11b and the second base 12b, as shown in FIG. 2. Preferably, the second end, which is opposite the first end where the bridge 13 is provided in the width direction z, is open.
[0041] Because bridge 13 has the above-described configuration, when connecting portion 22 is connected to clip base end 10B, i.e., between first base portion 11b and second base portion 12b, connecting portion 22 and bridge 13 can come into contact, making it possible to easily and stably connect connecting portion 22 to clip 10. Furthermore, a gap is formed between first portion 11 and second portion 12 at clip base end 10b, making it easy to connect connecting portion 22 to clip base end 10B.
[0042] 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 bridge 13. Alternatively, the medical clip 10 may be formed by joining a component including the first portion 11, a component including the second portion 12, and a component including the bridge 13. In particular, the medical clip 10 is preferably formed by bending a single metal plate including the first portion 11, the second portion 12, and the bridge 13. By forming the medical clip 10 from a single metal plate, variation in quality of the product is reduced during the manufacture of the medical clip 10, and manufacturing efficiency can be improved.
[0043] When the medical clip 10 is formed by joining together a component including the first portion 11, a component including the second portion 12, and a component including the bridge 13, the above description of the materials constituting the first portion 11 and the second portion 12 can be referenced for the material constituting the component including the bridge 13. The material constituting the component including the bridge 13 may be the same as or different from the materials constituting the component including the first portion 11 and the component including the second portion 12, but is preferably the same. The component including the bridge 13 can be joined to the component including the first portion 11 and the component including the second portion 12 by, for example, mechanical fastening such as screws, crimping, fitting, or press-fitting; fusion; welding; or bonding using adhesives or tapes. Among these, welding is preferred as the method for joining the component including the bridge 13 to the component including the first portion 11 and the component including the second portion 12. This increases the joining strength of each component.
[0044] The medical clip 10 has a space S between the first base portion 11b and the second base portion 12b that receives the connecting portion 22 of the linear object 20. Hereinafter, the space S that receives the connecting portion 22 may be referred to as the receiving space S. The receiving space S can be said to be a space defined by the first base portion 11b, the second base portion 12b, and the bridge 13.
[0045] When the connecting portion 22 is received in the receiving space S, the connecting portion 22 is fitted into the clip base end 10B, and the clip 10 and the linear object 20 can be connected. Conversely, when the connecting portion 22 moves out of the receiving space S and is detached from the clip base end 10B, the connection between the clip 10 and the linear object 20 can be released. At this time, the connecting portion 22 may be moved proximally by pulling the linear object 20 proximally, and the connecting portion 22 may be removed from the receiving section S.
[0046] When the medical clip 10 is not gripping biological tissue, the ring 30 is positioned at the distal end of its range of motion, and the connecting portion 22 is moved proximally. The force required to detach the connecting portion 22 from the clip proximal end 10B can be appropriately set depending on the application of the clip 10, but is preferably 20 N or greater. This prevents the clip 10 from unintentionally detaching from the connecting portion 22 during use of the clip system 1, thereby allowing for smooth treatment. Furthermore, if this force is too large, it becomes difficult to detach the clip 10 from the connecting portion 22, which is undesirable. The upper limit of this force may be, for example, 50 N. In this way, with the medical clip system 1, it is possible to appropriately set the force required for the connecting portion 22 to detach from the clip base end 10B when the connecting portion 22 is moved proximally, making it easier to release the connection between the clip 10 and the connecting portion 22 after the clip 10 has grasped the target area, such as a bleeding site, and allowing treatment using the medical clip system 1 to be carried out smoothly.
[0047] The medical clip 10 has a section in which the distance between the first base portion 11b and the second base portion 12b in the opening / closing direction y decreases from the clip base end 10b to the clip tip 10a, thereby providing a reduced section S1 in which the space S for receiving the connecting portion 22 reduces from the clip base end 10b to the clip tip 10a. The receiving space S is preferably composed of a non-reduced section S0, whose cross-sectional area does not reduce along the axial direction x, and a reduced section S1. In the axial direction x, the reduced section S1 is preferably located closer to the clip tip 10a than the non-reduced section S0, and the reduced section S1 is located closer to the clip tip 10a than the end 13b of the bridge 13 on the base end 10b side (hereinafter, sometimes referred to as the bridge base end 13b). With this configuration, when the receiving space S receives the connecting portion 22, the proximal side of the connecting portion 22 can be easily received while the distal side of the connecting portion 22 can be received and restrained in the reduced section S1, so that the clip 10 and the linear object 20 can be easily and stably connected, and it is possible to prevent the distal side of the connecting portion 22 of the linear object 20 from coming off the clip 10 when the clip 10 and the linear object 20 are connected to each other, resulting in a broken neck. The broken neck state is a state in which the clip 10 hangs from the tip of the linear object 20 and the clip 10 and the linear object 20 cannot be coaxial. In this state, it becomes impossible to transport the clip 10 to the treatment site or perform clipping, but the medical clip system 1 having the above configuration can prevent such a problem.
[0048] The reduced section S1 is preferably formed by shortening the distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b that define the receiving space S. In the non-reduced section S0, the distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b may increase or remain constant from the proximal side to the distal side, but is preferably the same. By keeping the distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b the same in the non-reduced section S0, the connecting portion 22 can be easily received in the non-reduced section S0 while preventing the proximal side of the connecting portion 22 from coming off the clip proximal end 10B.
[0049] The ratio of the distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b in the contracting section S1 to the distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b in the non-contracting section S0 is preferably 0.2 or more, more preferably 0.3 or more, even more preferably 0.4 or more, and is preferably 0.95 or less, more preferably 0.9 or less, and even more preferably 0.8 or less. The distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b in the contracting section S1 may be constant along the axial direction x, or may not be constant as long as it is within the above range.
[0050] The distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b in the contracting section S1 may gradually decrease from the proximal side to the distal side of the contracting section S1, which makes it easier to restrain the tip end of the connecting portion 22 by the contracting section S1 and more easily prevents the distal side of the connecting portion 22 from coming off the clip base end 10B and becoming broken.
[0051] In the axial direction x, the length of the contraction section S1 is preferably 10% or more of the length of the receiving section S, more preferably 15% or more, even more preferably 20% or more, and preferably 90% or less, more preferably 80% or less, and even more preferably 70% or less. In the axial direction x, one or more contraction sections S1 may be provided. When multiple contraction sections S1 are provided, the sum of the lengths of all contraction sections S1 in the axial direction x may be within the above range.
[0052] When a plurality of contraction sections S1 are provided, it is preferable that the distance in the opening / closing direction y between the first base portion 11b and the second base portion 12b does not increase from the proximal side to the distal side in the non-contraction section S0 between two contraction sections S1. With this configuration, when the clip 10 and the linear object 20 are connected, the contraction section S1 stably restrains the connecting portion 22, and when the clip 10 and the linear object 20 are released from each other, the connecting portion 22 can be easily detached from the clip base end portion 10B.
[0053] If the distance in the opening / closing direction y and the length in the axial direction x between the first base 11b and the second base 12b in the reduced section S1 are within the above ranges, the connecting portion 22 of the linear object 20 can be easily connected to the clip base end 10B, and the connected state between the linear object 20 and the clip 10 can be stably maintained, thereby preventing the distal side of the connecting portion 22 of the linear object 20 from coming off the clip base end 10B and causing a broken neck.
[0054] 3 and 4, in the contraction section S1, the inner walls of the first base portion 11b and the second base portion 12b preferably abut against the connecting portion 22. Since the inner walls of the first base portion 11b and the second base portion 12b abut against the connecting portion 22 in the contraction section S1, the connecting portion 22 is stably restrained in the contraction section S1, which makes it easier to prevent the distal side of the connecting portion 22 from coming off the clip base end portion 10B and causing a broken neck.
[0055] In the axial direction x, the length from the bridge base end 13b to the end 13a of the bridge 13 on the tip 10a side (hereinafter, sometimes referred to as the bridge tip 13a) is preferably greater than at least one of the length of the first base portion 11b in the width direction z and the length of the second base portion 12b in the width direction z. This stabilizes the connection between the first base portion 11b and the second base portion 12b by the bridge 13, making it less likely that the distance between the first base portion 11b and the second base portion 12b will change in the opening / closing direction y. As a result, the receiving space S can be prevented from becoming too wide, and for example, a problem can be prevented in which the connecting portion 22 comes off the clip 10 when fitting the connecting portion 22 into the clip base end 10B.
[0056] 1, the connecting portion 22 of the linear object 20 may be configured so that the outer diameter at the distal end is smaller than the outer diameter at the proximal end. This allows the portion of the connecting portion 22 with a smaller outer diameter to more easily fit into the reduced section S1, facilitating the connection between the linear object 20 and the clip 10. Alternatively, although not shown, the connecting portion 22 of the linear object 20 may have substantially the same outer diameter along the axial direction x. This allows the connecting portion 22 to be more easily restrained by the reduced section S1 after being fitted into the receiving section S, preventing the distal side of the connecting portion 22 from coming off the clip base end 10B and resulting in a broken neck.
[0057] As shown in FIG. 1 , the medical clip system 1 has a ring 30 having an inner cavity into which a medical clip 10 is inserted. The ring 30 is movable in the axial direction x relative to the clip 10 with the clip 10 disposed in the inner cavity. Before the clip 10 grasps biological tissue, the ring 30 is positioned closer to the clip base end 10b than the first arm 11a and the second arm 12a of the clip 10. When the ring 30 moves toward the clip distal end 10a in the axial direction x so that the first arm 11a and the second arm 12a are disposed in the inner cavity, the first arm 11a and the second arm 12a move in the closing direction in the opening / closing direction y, and the biological tissue is grasped between the first arm 11a and the second arm 12a.
[0058] The length in the axial direction x of the ring 30 is shorter than the length in the axial direction x from the clip base end 10b to the bridge tip 13a. Because the length in the axial direction x of the ring 30 is shorter than the length in the axial direction x from the clip base end 10b to the bridge tip 13a, the ring 30 is less likely to become an obstacle when connecting the connecting portion 22 of the linear object 20 to the clip base end portion 10B, making it easier to connect the linear object 20 and the clip 10.
[0059] The inner diameter of the ring 30 is preferably smaller than the outer diameter of the inner tube 25. As a result, by moving the linear object 20 proximally relative to the inner tube 25, the proximal end of the ring 30 comes into contact with the distal end of the inner tube 25, causing the ring 30 to move toward the clip tip 10a, thereby closing the clip 10. In addition, the outer diameter of the ring 30 is preferably smaller than the inner diameter of the outer tube 26. As a result, the clip 10 and the ring 30 can be accommodated in the inner cavity of the outer tube 26.
[0060] It is preferable that the force required to move the ring 30 in the axial direction x be set smaller than the force required to release the connecting portion 22 from the clip 10. This makes it possible to prevent the connection between the clip 10 and the connecting portion 22 from being unintentionally released when the ring 30 is moved in the axial direction x.
[0061] The cross-sectional shape of the ring 30 perpendicular to the axial direction x is not particularly limited, and may be, for example, a circle, an oval, a polygon, etc. Alternatively, the cross-sectional shape of the ring 30 perpendicular to the axial direction x may be a C-shape with a notch, or the ring 30 itself may be a coil formed by spirally winding a wire.
[0062] The ring 30 may be made of the same material as the medical clip 10, such as a metal, such as a Ni-Ti alloy, or stainless steel, such as SUS301, SUS303, SUS304, or SUS631. Of these, the material of the ring 30 preferably includes stainless steel.
[0063] 1, in the axial direction x, point P where the distance between first base portion 11b and second base portion 12b in the opening / closing direction y is shortest is preferably located closer to clip distal end 10a than end 13a on the distal end 10a side of bridge 13. Point P where the distance between first base portion 11b and second base portion 12b in the opening / closing direction y is shortest is the portion in contraction section S1 that can most effectively restrain connecting portion 22, so by positioning point P closer to clip distal end 10a than bridge distal end 13a, it becomes easier to restrain the distal side of connecting portion 22, and it becomes easier to prevent the distal side of connecting portion 22 from coming off clip base end 10B and becoming broken.
[0064] Preferably, the medical clip 10 and the linear object 20 are connected by fitting the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side in the width direction z. With this connecting method, the connecting portion 22 fitted from the second end side in the width direction z can be received by the bridge 13 provided on the first end side in the width direction z, and the clip 10 and the linear object 20 can be easily and stably connected. Furthermore, unlike conventional clip systems, there is no need to move the linear object 20 from the clip base end 10b in the axial direction x to insert the connecting portion 22 into the clip base end 10B, which improves connecting efficiency and prevents poor connection.
[0065] The force required to fit the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side in the width direction z of the clip 10 is preferably 0.05 N or more. By setting the lower limit of the force required to fit the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side in the width direction z where the bridge 13 is not disposed within the above range, it is possible to confirm whether the clip 10 and the connecting portion 22 are connected by the tactile sensation when the connecting portion 22 is pressed into the clip 10 to fit it. This prevents the clip 10 from being accidentally detached in an unintended situation when the medical clip system 1 is used in a treatment when the clip 10 and the connecting portion 22 are not properly connected. The upper limit of the force required to fit the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side in the width direction z of the clip 10 can be, for example, 10 N or less.
[0066] Alternatively, the medical clip 10 may be configured such that no force is required when fitting the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side of the clip 10 in the width direction z. Here, "no force required" includes a force of less than 0.05 N required to fit the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side of the clip 10 in the width direction z. Even in this configuration, the clip system 1 according to the embodiment of the present invention has the bridge 13 and the reduced section S1 located at predetermined positions, which allows the connecting portion 22 to be easily connected to the clip 10 and also stably maintains the connection state of the connecting portion 22 to the clip 10, thereby preventing the distal side of the connecting portion 22 from coming off the clip base end 10B, resulting in a broken neck.
[0067] When connecting the medical clip 10 and the linear object 20, it is preferable to fit the connecting portion 22 between the first base portion 11b and the second base portion 12b from the second end side in the width direction z, and then further perform an operation of pushing the linear object 20 toward the tip 10a in the axial direction x. This makes it easier to restrain the distal portion of the connecting portion 22 in the reduced section S1, and more easily prevents the distal side of the connecting portion 22 from coming off the clip base end portion 10B and becoming broken.
[0068] 3, when the medical clip 10 and the linear object 20 are connected, it is preferable that, in the axial direction x, the end of the connecting portion 22 on the clip tip 10a side, i.e., the distal end 22a, is located closer to the clip tip 10a side than the end 13b of the bridge 13 on the clip base end 10b side. By connecting the clip 10 and the linear object 20 in this manner, the connecting portion 22 of the linear object 20 can be supported by the bridge 13, and together with the constraint of the connecting portion 22 by the reduced section S1, it becomes easier to stably maintain the connecting portion 22, so that the clip 10 and the linear object 20 can be connected more easily and stably.
[0069] When the medical clip 10 and the linear object 20 are connected, it is more preferable that the distal end 22a of the connecting portion 22 is located closer to the clip tip 10a than the bridge base end 13b in the axial direction x, and the proximal end 22b of the connecting portion 22 is located closer to the clip base end 10b than the bridge base end 13b. This increases the contact area between the bridge 13 and the connecting portion 22, increasing the frictional force generated between the bridge 13 and the connecting portion 22, and making it possible to more easily and stably connect the clip 10 and the linear object 20.
[0070] 4 and 5, the connecting portion 22 of the linear object 20 preferably has a contact portion 23 that contacts the base end 10b of the medical clip 10. The contact portion 23 contacts the clip base end 10b, thereby preventing movement of the linear object 20 in the axial direction x and preventing the connection between the clip 10 and the connecting portion 22 from being released in an unintended situation.
[0071] As shown in FIG. 4 , the medical clip 10 preferably further includes a first claw 110 protruding from the base end 10b of the first base 11b toward the second base 12b, and a second claw 120 protruding from the base end 10b of the second base 12b toward the first base 11b. Even when the clip 10 includes the first claw 110 and the second claw 120, the first claw 110 and the second claw 120 do not abut each other, and the first portion 11 and the second portion 12 are not connected except via the bridge 13. That is, a gap is formed between the first claw 110 and the second claw 120. Due to this gap, even when the clip 10 includes the first claw 110 and the second claw 120, the clip 10 and the linear object 20 can be easily connected by the linear object 20 passing through the gap.
[0072] The clip 10 has the first claw portion 110 and the second claw portion 120, which prevents the linear object 20 from moving proximally relative to the clip 10. Furthermore, the first claw portion 110 and the second claw portion 120 can restrain the connecting portion 22, which, together with the restraint of the connecting portion 22 by the reduced section S1, makes it easier to maintain a stable connected state between the linear object 20 and the clip 10.
[0073] When the medical clip 10 has completed grasping the biological tissue and the clip 10 is to be removed from the linear object 20 to place it in place, it is preferable that the connecting portion 22 pushes the first claw portion 110 and the second claw portion 120 from the distal side toward the proximal side to deform them, and then moves the connecting portion 22 proximally so that the connecting portion 22 passes through the gap between the first claw portion 110 and the second claw portion 120 to remove the clip 10 from the linear object 20. With this configuration, the connecting portion 22 will not come off the clip 10 unless it is moved proximally with a force greater than or equal to the force that deforms the first claw portion 110 and the second claw portion 120, and therefore unintentional removal of the clip 10 from the linear object 20 can be prevented.
[0074] The first claw portion 110 may be formed by bending the proximal end portion of the first base portion 11b, or may be formed by joining a component constituting the first claw portion 110 (hereinafter, sometimes referred to as a "first claw portion component") to the proximal end portion of the first base portion 11b. Similarly, the second claw portion 120 may be formed by bending the proximal end portion of the second base portion 12b, or may be formed by joining a component constituting the second claw portion 120 (hereinafter, sometimes referred to as a "second claw portion component") to the proximal end portion of the second base portion 12b. In particular, it is preferable that the first claw portion 110 is formed by bending the proximal end portion of the first base portion 11b, and the second claw portion 120 is formed by bending the proximal end portion of the second base portion 12b. By forming them in this manner, it is possible to prevent the first claw portion 110 from coming off the first base portion 11b and the second claw portion 120 from coming off the second base portion 12b, and even if a load is applied to the first claw portion 110 and the second claw portion 120 when connecting or disconnecting the clip 10 and the linear object 20, the first claw portion 110 and the second claw portion 120 are less likely to be damaged.
[0075] When the first claw portion 110 is formed by joining a first claw part to the first base portion 11b, and the second claw portion 120 is formed by joining a second claw part to the second base portion 21b, the first claw part and the second claw part can be joined to the first base portion 11b and the second base portion 12b, respectively, by, for example, mechanical fastening using a connecting member such as a screw, crimping, fitting, or press-fitting; fusion; welding; or adhesion using an adhesive, tape, or the like. Among these, it is preferable that the first claw part and the second claw part are joined to the first base portion 11b and the second base portion 12b, respectively, by welding. This increases the joining strength.
[0076] 5, the first claw portion 110 and the second claw portion 120 preferably have notches 111, 121 that follow the outer periphery of the linear object 20. The notches 111, 121 may be provided along the outer periphery of the linear object main body 21, or may be provided along the outer periphery of the connecting portion 22. This makes it possible to prevent excessive play from occurring between the first claw portion 110 and the second claw portion 120 and the linear object 20 when the linear object 20 is placed in the gap between the first claw portion 110 and the second claw portion 120 when connecting the clip 10 and the linear object 20, making it easier to restrain the linear object 20 by the first claw portion 110 and the second claw portion 120.
[0077] 6, the connecting portion 22 has a groove portion 24 that is concave in the circumferential direction of the connecting portion 22, and it is preferable that a distal side surface 24a of the groove portion 24 contacts the distal side surfaces of the first claw portion 110 and the second claw portion 120, and a proximal side surface 24b of the groove portion 24 contacts the proximal side surfaces of the first claw portion 110 and the second claw portion 120. With this configuration, the proximal end of the clip 10 is fitted into the groove portion 24 of the connecting portion 22, so that the clip 10 and the connecting portion 22 are reliably connected, and unintentional release of the connection between the clip 10 and the linear object 20 is less likely to occur.
[0078] The length of groove 24 in the axial direction x is preferably longer than the thickness of first claw 110 and second claw 120 in the axial direction x, and is preferably no more than twice the thickness of first claw 110 and second claw 120 in the axial direction x. This makes it easier to fit connecting portion 22 between first base 11b and second base 12b from the second end side in the width direction z, facilitating connection between linear object 20 and clip 10.
[0079] In a state in which the clip 10 and the linear object 20 are connected, the connecting portion 22 may be located distal to the clip base end 10b as shown in Fig. 3, or a part of the connecting portion 22 may be located distal to the clip base end 10b, and the remaining part may be located proximal to the clip base end 10b as shown in Fig. 4. In this case, the connecting portion 22 may have a groove 24, and a part of the groove 24 proximal to the proximal side surface 24b may be located proximal to the proximal side surfaces of the first claw portion 110 and the second claw portion 120.
[0080] Although not shown, the medical clip system 1 preferably has a handle connected to the proximal end of the linear member 20. The handle is a member that a user holds when activating the medical clip system 1. Providing the medical clip system 1 with a handle makes it easier to operate the medical clip system. [Explanation of symbols]
[0081] 1: Medical Clip System 10: Medical clips 10a: Clip tip 10b: Clip base end 10B: Clip base end 11: Part 1 11a: 1st arm 11b: 1st base 12: Part 2 12a: 2nd arm 12b:Second base 13: Bridge 13a: Bridge tip 13b: Bridge base 20: Linear object 21: Linear object body 22:Connection part 22a: Distal end of the connection 22b: Proximal end of the connection 23: Contact part 24: Groove 24a: Distal side of the groove 24b: Proximal side of the groove 25: Inner cylinder 26: Outer cylinder 30: Ring 110: 1st claw part 120:Second claw part 111, 121: Notch M: Midpoint of the axial length of the medical clip P: The shortest point between the first and second bases S: Receiving section S0: Non-reducing section S1: Shrinking section x: Axial direction y: Open / close direction z: Width direction
Claims
1. A medical clip system comprising: a medical clip having a first part and a second part opposed to each other and configured to grip biological tissue; a ring having an inner cavity into which the medical clip is inserted; and a linear object having a connecting part that is connected to the medical clip, the medical clip has a base end and a tip end, an opening / closing direction, an axial direction from the base end to the tip end, and a width direction perpendicular to the opening / closing direction and the axial direction, the first section has a first arm section that grasps the biological tissue and a first base section that is located closer to the base end than the first arm section, and the second section has a second arm section that grasps the biological tissue and a second base section that is located closer to the base end than the second arm section, the medical clip has a first end side and a second end side in the width direction, and a bridge on the first end side that connects the first base portion and the second base portion, the medical clip has a section in which the distance between the first base portion and the second base portion in the opening and closing direction decreases from the base end to the tip end, thereby having a reduced section in which a space for receiving the connecting portion decreases from the base end to the tip end, In the axial direction, the bridge is located closer to the tip end than the base end and closer to the base end than the first arm portion and the second arm portion, In the axial direction, the reduced section is located closer to the distal end than the proximal end of the bridge, the first base portion and the second base portion are not connected except via the bridge, an axial length of the ring is shorter than an axial length from the base end of the medical clip to the distal end of the bridge; A medical clip system in which, when the medical clip and the linear object are connected, the inner walls of the first base and the second base abut the connecting portion in the contracted section, and the tip of the connecting portion is constrained by the contracted section.
2. 2. The medical clip system according to claim 1, wherein a point P at which the distance between the first base portion and the second base portion in the opening and closing direction is shortest in the axial direction is located closer to the tip than the tip end of the bridge.
3. 3. The medical clip system according to claim 1, wherein the medical clip and the linear object are connected by fitting the connecting portion between the first base portion and the second base portion from the second end side in the width direction.
4. A medical clip system according to any one of claims 1 to 3, wherein when the medical clip and the linear object are connected, in the axial direction, the tip end of the connecting portion is located closer to the tip than the base end of the bridge.
5. 5. The medical clip system according to claim 1, wherein the connecting portion has a contact portion that contacts the base end of the medical clip.
6. A medical clip system according to any one of claims 1 to 5, wherein the medical clip further has a first claw portion protruding from the base end of the first base toward the second base, and a second claw portion protruding from the base end of the second base toward the first base.
7. The medical clip system according to claim 6 , wherein the first claw portion and the second claw portion have a notch along the outer periphery of the linear object.
Citation Information
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