Biocompression Comb Clip

The biocompression comb clip addresses manufacturing challenges and fluorescence visibility issues by using a metal body with a flexible resin compression piece to enhance clamping force and visibility, expelling blood for clear observation.

JP7602753B2Active Publication Date: 2024-12-19NATIONAL UNIVERSITY CORPORATION KOCHI UNIVERSITY +1
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Patent Information

Application Number
JP2022121423
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Filing Date
2022-07-29
Publication Date
2024-12-19
Estimated Expiration
2041-12-28

AI Technical Summary

Technical Problem

Existing metal clips used for marking surgical sites require significant manufacturing changes and have weaker clamping force, while clips with fluorescent resin components struggle with fluorescence visibility due to blood absorption, especially when pinching mucosal tissue.

Method used

A biocompression comb clip with a metal body and flexible fluorescent resin compression piece that protrudes from the arm ends, compressing tissue to enhance fluorescence visibility by expelling blood, and is easily fixed to the arm using a comb-shaped design.

Benefits of technology

The clip effectively compresses tissue to improve fluorescence intensity, allowing clear observation from the serosa side by expelling blood and enhancing resin thickness for better visibility, while maintaining strong clamping force.

✦ Generated by Eureka AI based on patent content.

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Abstract

To make it possible to easily fix a member made of a fluorescent resin to a metal clip body when a clip used by being mounted on an endoscope clip device is formed of the clip body and the member made of the fluorescent resin, and to improve fluorescence intensity to be observed.SOLUTION: A comb-toothed living body compressing clip 100 comprises a clip body 1 including metal arm parts 3a and 3b for clamping a living tissue, where the clip 100 is so configured that tip-side areas 5 of the arm parts have a comb-toothed shape, and the tip-side areas 5 of the arm parts 3a and 3b include compressing pieces 20 protruding from tips of the arm parts 3a and 3b in a longitudinal direction of the arm parts 3a and 3b. The compressing pieces 20 are formed of a flexible resin and has fluorochrome. According to the comb-toothed living body compressing clip 100, while the arm parts 3a and 3b clamp the living tissue, the compressing pieces 20 compress a vascular network, causing it to collapse.SELECTED DRAWING: Figure 1
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Description

[Technical field]

[0001] The present invention relates to a clip that is useful as a marker for identifying the location of an affected area. [Background technology]

[0002] Metal clips that are attached to endoscopic clip devices have been widely used as hemostatic clips or marker clips for identifying the location of affected areas during surgery. For example, there are clips made by bending a metal leaf spring such as stainless steel into an L-shape, and clips made of a metal clip body formed into an L-shape and a fastener that fits over and fastens the clip body (Patent Document 1).

[0003] The present inventor has proposed forming the fastening tool of the clip from a resin containing a fluorescent dye (hereinafter also referred to as fluorescent resin) (Patent Document 2) or forming the clip body itself from a fluorescent resin (Patent Document 3) in order to make it possible to confirm the position of the clip from the serosal side after clamping the mucosal tissue of a hollow organ with such a clip. When the mucosal tissue is clamped with these clips, the mucosal tissue is compressed and blood in the vascular network under the mucosa is expelled, so when excitation light is irradiated from the serosal side to emit the fluorescent dye, the emitted fluorescence is hardly absorbed by the blood in the vascular network, and the fluorescence can be observed from the serosal side, making it possible to clearly confirm the position of the clip.

[0004] As a clip using a fluorescent dye, one has been proposed in which a movable member made of fluorescent resin is attached to the tip of the clip so as to be rotatable by a hinge (Patent Document 4). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent No. 6572229 [Patent Document 2] Patent No. 6161096 [Patent Document 3] Patent No. 6675674 [Patent Document 4] Patent Publication No. 2021-69802 Summary of the Invention [Problem to be solved by the invention]

[0006] However, the clip described in Patent Document 2 requires that the fastener made of fluorescent resin has a specific shape so that the fastener can compress mucosal tissue, and the clip described in Patent Document 3 requires that the clip body made of fluorescent resin has a specific shape so that the clip can open and close. Therefore, these clips require a manufacturing method that is significantly different from that of conventional metal clips. In addition, the clip described in Patent Document 3 has a problem in that it has a weaker clamping force on biological tissue than conventional metal clips.

[0007] In the clip described in Patent Document 4, when mucosal tissue is clamped, the movable member made of fluorescent resin rotates on a hinge to assume a position in contact with the mucosa; the movable member cannot compress the mucosal tissue or remove blood from the vascular network, and therefore the fluorescence emitted by the movable member is difficult to observe on the serosal side.

[0008] In contrast, the present invention has an objective to form a clip that is to be attached to an endoscopic clip device and used from a metal clip body and a member formed of fluorescent resin, so that the member formed of fluorescent resin can be easily fixed to the clip body and the observed fluorescence intensity can be improved. [Means for solving the problem]

[0009] The inventors conceived the present invention based on the idea that if a compression piece formed of a flexible fluorescent resin is attached to the tip of the arm of a metal clip body that clamps biological tissue, so that it protrudes in the longitudinal direction of the arm, the biological tissue can be compressed by the protruding part of the compression piece when it is clamped by the clip, thereby improving the observed fluorescence intensity, and that if the tip side region of the arm to which the compression piece is attached is shaped like comb teeth, it becomes easier to fix the compression piece to the arm, and further, if the space between the comb teeth is filled with the compression piece, the resin thickness of the compression piece in the observation direction increases, thereby dramatically improving the observed fluorescence intensity.

[0010] In other words, the present invention provides a biological compression comb-tooth clip, which is a clip equipped with a clip body having a metal arm portion that clamps biological tissue, wherein the tip side region of the arm portion is comb-shaped and the tip side region of the arm portion has a compression piece protruding from the tip of the arm portion in the longitudinal direction of the arm portion, the compression piece being formed from a flexible resin and holding a fluorescent dye, and the compression piece compresses the biological tissue while the arm portion is clamping the biological tissue. Effect of the Invention

[0011] According to the biological compression comb-shaped clip of the present invention, a compression piece holding a fluorescent dye is provided in the distal end region of the arm portion, and this compression piece has a portion protruding from the distal end of the arm portion and is flexible, so that when the arm portion is clamping biological tissue, the protruding portion of the compression piece bends and the bent portion presses the biological tissue in the thickness direction of the biological tissue. In particular, when the compression piece has elasticity, the compression piece presses the biological tissue by the elastic force that tries to return to the original bend. Therefore, for example, when the arm portion clamps the mucosal tissue of a hollow organ, the protruding portion of the compression piece bends and presses the mucosa, causing the mucosa to become thinner. Therefore, when the compression piece is irradiated with excitation light to cause the fluorescent dye held in the compression piece to emit fluorescence, the fluorescence emission can be clearly confirmed from the serosal membrane side.

[0012] That is, when the mucosal tissue is compressed, the blood vessels of the vascular network of arteries and veins in the submucosa collapse, blood is expelled from the blood vessels, and hemoglobin is also expelled. Therefore, if a fluorescent dye that emits red to near-infrared light when irradiated with excitation light is used, the excitation light is absorbed by the fluorescent dye of the compression piece without being absorbed by hemoglobin, and the fluorescence emitted by the fluorescent dye is also emitted to the serosal membrane side without being absorbed by hemoglobin. Therefore, it is possible to clearly observe the emission of the compression piece of the biological compression comb clip attached to the mucosa of the hollow organ from the outside of the hollow organ.

[0013] In addition, in the biological compression comb-tooth clip of the present invention, the tip side region of the arm portion on which the compression piece is provided is comb-tooth shaped, so that the compression piece can be easily fixed to the arm portion by insert molding, adhesive bonding, etc.

[0014] Furthermore, in the tip region of the arm portion, the space between the comb teeth can be filled with compression pieces, and fluorescent resin that forms the compression pieces can also be placed on the inside of the clip (the clamping surface side), so that the resin thickness of the compression piece when viewed from the observation direction becomes thicker, and the observed fluorescence intensity is significantly improved. [Brief description of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view of a living body compression comb clip according to an embodiment in an open state. [Figure 2A] FIG. 2A is a perspective view of an embodiment of a biocompression comb clip in a closed state. [Figure 2B] FIG. 2B is a side view of an embodiment of a biocompression comb clip in a closed state. [Figure 2C] FIG. 2C is a top view of an embodiment of a biocompression comb clip in a closed state. [Diagram 3] FIG. 3 is a perspective view of a clip body used in the living body compression comb clip of the embodiment in an open state. [Figure 4A]FIG. 4A is a top view of a clip body used in the living body compression comb-like clip of the embodiment in a state where it is closed by a fastener. [Figure 4B] FIG. 4B is a front view in the direction A of the clip body used in the living body compression comb-tooth clip of the embodiment in a state where it is closed by a fastener. [Figure 4C] FIG. 4C is a side view taken from the direction B of the clip body used in the living body compression comb-tooth clip of the embodiment in a state where it is closed by a fastener. [Figure 5A] FIG. 5A is an explanatory diagram of a method of using the living body compression comb-shaped clip of the embodiment using an endoscope device. [Figure 5B] FIG. 5B is an explanatory diagram of a method of using the living body compression comb-shaped clip of the embodiment using an endoscope device. [Figure 5C] FIG. 5C is an explanatory diagram of a method of using the living body compression comb-like clip of the embodiment using an endoscope device. [Figure 5D] FIG. 5D is an explanatory diagram of a method of using the living body compression comb-like clip of the embodiment using an endoscope device. [Figure 6A] FIG. 6A is a cross-sectional view illustrating the action of the living body compressing comb-shaped clip of the embodiment on the mucous membrane. [Figure 6B] FIG. 6B is a cross-sectional view illustrating the action of the living body compressing comb-shaped clip of the embodiment on the mucous membrane. [Figure 6C] FIG. 6C is a cross-sectional view illustrating the action of the living body compressing comb-shaped clip of the embodiment on the mucous membrane. [Figure 6D] FIG. 6D is a cross-sectional view illustrating the action of the living body compression comb-shaped clip of the embodiment on the mucosa. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] The present invention will now be described in detail with reference to the drawings, in which the same reference numerals denote the same or equivalent components.

[0017] <Overall structure of the biocompression comb clip> Fig. 1 is a perspective view of a biocompression comb clip 100 according to an embodiment of the present invention in an open state, and Fig. 2A is a perspective view of the biocompression comb clip 100 in a closed state. Fig. 3 is a perspective view of a clip body 1 used in the biocompression comb clip 100 according to the embodiment in an open state.

[0018] This biological compression comb-like clip 100 includes a metal clip body 1, compression pieces 20 provided in the tip end regions of the arms 3a and 3b of the clip body 1, and a fastener (rivet ring) 2. For ease of understanding in the drawings, the compression pieces 20 are filled with dots, and the fastener is depicted semi-transparently. Hereinafter, the body compressing comb-like clip 100 of the present invention will be abbreviated to clip 100.

[0019] <Clip body> The clip 100 of this embodiment is attached to an endoscopic clipping device (applier) and used to clip biological tissue, and the clip body 1 is formed of a pair of arms 3a and 3b obtained by bending a strip-shaped metal plate. The arms 3a and 3b act as leaf springs.

[0020] One end (rear end) of the arm portions 3a, 3b is narrow, and the other end (front end) is wide. At the narrow rear end, the pair of arm portions 3a, 3b are connected and curved in a U-shape. The operating wire of the applier is engaged at this connected portion 4.

[0021] In the present invention, the clip body 1 is not limited to one obtained by bending a strip-shaped metal plate into a U-shape, and may be, for example, a leaf spring formed into a V-shape by bending the center of a strip-shaped metal plate as shown in FIG. 3 of Japanese Patent No. 6572229 (Patent Document 1). As shown in FIG. 7 of Japanese Patent No. 6694893, the clip body may be formed from two leaf springs whose rear ends are bent into an L-shape, and in this case, a reinforcing member may be provided near the rear ends of the two leaf springs to connect them. Also, the clip body 1 may be configured so that a pair of arm portions cross each other as shown in Japanese Patent No. 4145149.

[0022] When the clip is in an open state, the pair of arm portions 3a, 3b are curved backwards, and thus the distance between their tip end regions 5 is greatly increased.

[0023] (Comb-tooth tip region) In the present invention, the tip side region 5 of the arm parts 3a and 3b is mainly configured to have a comb-like shape in which multiple comb teeth 6 are arranged in parallel, and in this embodiment, two comb teeth 6 are arranged in parallel in each of the tip side regions 5 of the pair of arms 3a and 3b. Here, the tip side region 5 of the arm parts 3a and 3b is a region extending from the tip of the arm parts 3a and 3b to the rear end side, and is a part that holds biological tissue. In the present invention, it is sufficient that at least a part of the tip side region is comb-like, and the comb-like part may extend from the tip side region to the rear end side. By making the tip side region 5 of the arm parts 3a and 3b comb-like, it becomes easy to fix the compression piece 20 to the tip side region 5 of the arm parts. Furthermore, the inter-tooth space 7 can be filled with fluorescent resin that forms the compression piece 20, and it is also easy to place fluorescent resin on the inner portion of the tip side region 5 of the arm portions 3a, 3b. As a result, as described below, when the clip of the present invention is attached to the mucosa and observed from the serosal membrane side, the resin thickness of the compression piece is increased, and the fluorescence intensity can be significantly improved (Figure 6D).

[0024] In contrast, in the tip-end side region 5 of the arms 3a and 3b, if the inter-comb space 7 is closed at the tip of the arms to form a hole, and the arms 3a and 3b are not comb-shaped, even if the hole is filled with fluorescent resin forming the compression piece, the fluorescence emitted from the fluorescent resin in the hole in the observation direction will be blocked by the tip of the arm. In addition, it will be difficult to arrange the fluorescent resin forming the compression piece inside the arms 3a and 3b.

[0025] The number of teeth of the comb teeth 6 in the tip end region 5 of each of the arm portions 3a, 3b is two or more, and preferably two to three.

[0026] In each of the arms 3a, 3b, a hole 8 is provided on the continuous portion 4 side of the region where the comb teeth 6 are formed, as necessary, in order to ensure that the compression piece 20 is fixed to the arm parts 3a, 3b, and the convex part of the compression piece 20 protrudes into this hole 8. The number of the hole 8 is not limited to one.

[0027] In this embodiment, the sides 9 of the arms 3a and 3b are formed flat, but if necessary, the sides 9 may be bent inwardly into an L-shape to stand up, thereby increasing the rigidity of the arms 3a and 3b.

[0028] (Claw part) The clip body 1 has claws 10 at the tips of the comb teeth 6 that stand inward of the clip body 1 (FIG. 4C). The claws 10 are the parts that directly bite into the biological tissue and hold the biological tissue. In this embodiment, the claws 10 are triangular in shape to allow the claws 10 to easily bite into the biological tissue.

[0029] In the present invention, the claw portion 10 is not limited to a triangular shape, but may be rectangular. It may also be a triangular wave shape formed by connecting triangular shapes, or a rectangular wave shape.

[0030] The claw portion 10 is provided so as to be spaced apart from the central axis X of the clip body 1 when the clip body 1 is in a closed state (FIG. 4B). Here, the central axis X of the clip body 1 is an axis that bisects the width W1 of the clip body 1 in a top view (FIG. 4A) and is equidistant from the pair of arm portions 3a, 3b in a side view of the clip body 1 (FIG. 4C). As a result, when mucosal tissue is clamped with the clip 100 and excitation light is irradiated and observed from the serosal side, the fluorescence emitted from the inner part 23 of the compression piece 20 is prevented from being blocked by the claw portion 10, thereby improving the observable fluorescence intensity.

[0031] In this embodiment, the claws 10 of the pair of arms 3a, 3b overlap each other while being shifted in the front-rear direction as shown in Fig. 4C when the clip body 1 is closed. This allows the claws 10 to be spaced apart from the central axis X of the clip body 1 while being of a sufficient length to bite into biological tissue. If necessary, the tips of the claws 10 of the pair of arms 3a, 3b may be made to abut against each other.

[0032] <Fasteners> The fastener 2, which is also called a crimping ring, opens the clip body 1 when positioned on the continuous portion 4 side of the clip body 1 (FIG. 3) and closes the clip body 1 when positioned on the claw portion 10 side (FIG. 4C). The fastener 2 in this embodiment is formed of a metallic cylindrical member. The fastener 2 may be a coil of wire or a C-shaped cross section perpendicular to the longitudinal direction.

[0033] <Compression piece> The compression pieces 20 are provided on the tip end regions 5 of the arm portions 3a and 3b of the clip body 1. The compression pieces 20 are made of a flexible resin. The compression pieces 20 also hold a fluorescent dye.

[0034] The compression pieces 20 are also a main component of the present invention. The compression pieces 20 protrude from the distal ends of the arm portions 3a, 3b in the longitudinal direction of the arm portions 3a, 3b.

[0035] The compression piece 20 is made of a flexible resin and holds a fluorescent dye. For example, the compression piece 20 may be made of a flexible resin containing a fluorescent dye. Alternatively, a coating film containing a fluorescent dye may be formed on the surface of a compression piece made of a flexible resin. Since the compression piece 20 is made of flexible resin, the protruding portion 21 of the compression piece 20 protruding from the tip of the arm portion 3a, 3b is bent as shown by the broken line in FIG. 2B. Therefore, as described later, when the arm portions 3a, 3b of the clip body 1 are clamping the biological tissue, the protruding portion 21 of the compression piece 20 is bent, and the bent portion presses the biological tissue in the thickness direction of the biological tissue (the longitudinal direction of the arm portions 3a, 3b in the state of clamping the biological tissue) (FIG. 6D). The compression piece 20 is preferably elastic, and the biological tissue is strongly compressed in the thickness direction by the elastic force that tries to return the bending of the compression piece 20. Therefore, blood is expelled from the vascular network of the submucosa, and when the excitation light is irradiated to the compression piece 20 from the serosal side to cause the fluorescent dye held in the compression piece to emit fluorescence, the fluorescence can be clearly confirmed from the serosal side.

[0036] (Shape of compression piece) The compression piece 20 in this embodiment has a roughly rectangular shape, and has a protruding portion 21 protruding from the tip of the arm portions 3a and 3b, a dorsal portion 22 located on the dorsal side of the arm portions 3a and 3b, and an inner portion 23 located on the inside, and the dorsal portion 22 and the inner portion 23 in the tip side region 5 of the arm portions 3a and 3b are continuous with each other through the inter-comb space 7.

[0037] The thickness D1 of the protruding portion 21 is determined so that the compression pieces 20 attached to the pair of arm portions 3a, 3b come into contact with each other when the clip 100 is closed.

[0038] The compression piece 20 also has a reinforcing portion 24 that fills the hole 8 of the arm portions 3a and 3b and protrudes from the hole 8. Therefore, the compression piece 20 is firmly attached to the tip end region 5 of the arm portions 3a and 3b.

[0039] A compression piece having such a shape can be easily formed by insert molding using the tip end side regions 5 of the arm portions 3a, 3b as insert parts.

[0040] In the present invention, if necessary, a compression piece 20 formed separately from the arm portions 3a, 3b may be bonded to the back or inside of the tip end region of the arm portions 3a, 3b so as to fill the inter-tooth space 7. Even in this case, a protrusion for filling the hole portion 8 of the arm portion can be formed as necessary.

[0041] In addition, in the present invention, in order to adjust the compression force applied to the biological tissue by the bent compression piece 20 when the clip 100 clamps the biological tissue, if necessary, a constriction or a notch may be provided in the compression piece 20 near the tip of the arm portion in the width direction (short direction) of the arm portion.

[0042] The protruding length L1 (FIG. 2B) from the tip of the arm portions 3a, 3b of the compression pieces 20 is preferably 2 to 10 mm, since if it is too long, it becomes difficult for the clip body to clamp biological tissue. The total length L2 of the compression pieces 20 is preferably 5 to 13 mm, since if it is too short, the attachment strength of the compression pieces 20 to the arm portions 3a, 3b becomes insufficient, and if it is too long, it becomes difficult to use the clip 100 in the endoscopic clip device.

[0043] If the width W2 (Figure 2C) of the protruding portion 21 of the compression piece 20 in a top view is too short, it is difficult to obtain the compression force from the compression piece 20, and if it is too long, it is difficult to attach the clip 100 to an endoscopic clip device. Therefore, it is preferable that the width W2 (Figure 2C) of the protruding portion 21 of the compression piece 20 in a top view is 0.4 to 1.0 mm larger than the width W1 of the clip body 1, or that the width W2 of the protruding portion of the compression piece 20 in a top view is 1.4 to 2.6 mm.

[0044] (Flexible resin that forms the compression piece) The flexible resin forming the compression piece 20 is preferably one that does not denature even if left in the digestive tract for a long period of time and has acid resistance to stomach acid. Examples of such flexible resins include resins used in medical devices, such as soft polyvinyl chloride, thermoplastic polyurethane, silicone, and ethylene-vinyl acetate copolymer.

[0045] In addition, it is preferable that the flexible resin forming the compression piece 20 has appropriate hardness and elasticity so that the protruding portion 21 of the bent compression piece 20 can effectively compress the biological tissue when the arm portions 3a, 3b of the clip body 1 are clamping the biological tissue.

[0046] The hardness of the compression piece 20 is preferably in the range of A10 to A90 as Shore A (JIS K 6253) or D40 to D70 as Shore D (JIS K 6253) measured with a durometer. The hardness of the compression piece 20 is preferably selected appropriately depending on the shape, size, etc. of the compression piece 20.

[0047] The elasticity of the compression piece 20 is preferably such that the flexural modulus (ASTM D790) is 4 to 200 MPa, and more preferably 10 to 100 MPa.

[0048] (Fluorescent dye) The fluorescent dye held in the compression piece 20 is preferably one that emits fluorescence in the red light to near infrared light wavelength range of 600 to 1400 nm, preferably in the red light or near infrared light wavelength range of 700 to 1100 nm. Light in this wavelength range is highly permeable to human tissues such as skin, fat, and muscle, and can easily reach, for example, the mucous membrane to the serosal surface of tubular human tissues such as the rectum.

[0049] Examples of fluorescent dyes that emit fluorescence in the above-mentioned wavelength ranges include riboflavin, thiamine, NADH (nicotinamide adenine dinucleotide), indocyanine green (ICG), an azo-boron complex compound described in JP 2011-162445 A, a dye having a condensed ring structure described in WO 2016 / 132596 A, a dye having a boron dipyrromethene skeleton described in JP 5177427 A, a dye that chemically bonds to silica particles described in JP 2020-74905 A, and a phthalocyanine dye described in JP 2020-105170 A.

[0050] Specific examples of the method of retaining the fluorescent dye in the compression piece 20 include incorporating the fluorescent dye into the flexible resin forming the compression piece 20, and forming a coating film containing the fluorescent dye on the surface of a compression piece formed from a flexible resin. In order to better demonstrate the effect of the present invention, which is to improve the fluorescence intensity observed when a biological tissue is clamped with the clip 100 by forming the tip end region of the arm part into a comb-like shape and providing compression pieces in the spaces between the comb teeth and on the inside of the arm part, it is preferable to incorporate the fluorescent dye into the flexible resin forming the compression piece.

[0051] When a fluorescent dye is contained in the flexible resin forming the compression piece 20, a preferable concentration of the fluorescent dye can be set according to the type of the fluorescent dye and the resin, and is usually preferably 0.001 to 1% by mass.

[0052] As a method for incorporating the fluorescent dye into the flexible resin, for example, the fluorescent dye may be kneaded into the flexible resin using a twin-screw kneader.

[0053] A contrast agent such as barium sulfate may be added to the flexible resin as necessary. This makes it possible to track the clip 100 in the living body by photographing it with X-rays even if the clip 100 that has been holding the mucosa in the living body becomes detached from the mucosa.

[0054] (Method of forming compression pieces) A preferred method for forming the compression piece 20 is, for example, insert molding with the clip body 1 to obtain a compression piece 20 fixed to the clip body 1. Alternatively, the compression piece 20 can be obtained by forming a flexible resin kneaded with a fluorescent dye into a predetermined shape by extrusion molding or injection molding, and then performing processing such as cutting to a fixed length, removing corners, forming recesses, etc. The obtained compression piece can be bonded to the clip body 1 with an adhesive.

[0055] <How to use the biocompression comb clip> As a method of using the biocompression comb-shaped clip 100, first, as shown in FIG. 5A, the clip 100 including the clip body 1 having the compression piece 20 and the fastener 2 is attached to the clip sheath 30 of the endoscopic applier. As the clip sheath 30, for example, one having an inner sheath 33, an outer sheath 34, and an operation wire 31 described in Japanese Patent No. 4388324, Japanese Patent No. 5045484, etc., can be used, and a commercially available one can be used. As a method of attaching the clip 100 to the clip sheath 30, for example, as shown in FIG. 5A, the connecting part 32 of the operation wire 31 may be hooked to the rear end part (continuous part 4) of the clip body 1. In addition, when the clip body 1 is formed from a leaf spring bent into a V-shape, a U-shape, etc., a hook may be used as described in Japanese Patent No. 5781347, etc.

[0056] When clip 100 is retracted into outer sheath 34 by operating the applier, clip body 1 closes as shown in Fig. 5B, and when clip body 1 is protruded from outer sheath 34, clamping surface 12 side of clip body 1 opens as shown in Fig. 5C. Also, when inner sheath 33 is brought into contact with fastener 2 and operating wire 31 is retracted to slide fastener 2 toward the tip end as shown in Fig. 5C, clip body 1 gradually closes, and finally clip body 1 that was open is completely closed as shown in Fig. 5D.

[0057] The case where the clip 100 is used to clamp an affected part of the mucosa of a hollow organ using the opening and closing mechanism of the clip 100 will be described below. The clip body 1 is attached to the operating wire 31, the clip 100 is pulled into the outer sheath 34, and the clip sheath 30 is inserted into the inside of the hollow organ with the clip body 1 closed. The applier is operated to project the clip 100 from the outer sheath 34, and the distal end side of the arms 3a and 3b of the clip body 1 is opened near the affected part 41 (FIG. 6A). Next, the clip 100 is brought into contact with the mucosa 40, and the fastener 2 is moved toward the distal end. Depending on the amount of movement, the clip body 1 closes, and the protruding part 21 of the compression piece 20 is bent (FIGS. 6B and 6C). When the clip body 1 is completely closed, the clamping surface 12 clamps the mucosa 40 near the affected part 41 (FIG. 6D). At this time, the protruding portion 21 of the compression piece 20 is bent as shown in Fig. 6D, and the compression piece 20 compresses the mucosa 40 in a direction that reduces the thickness of the mucosa 40. In particular, if the compression piece 20 has elasticity, the elastic force in the direction of returning the compression piece 20 to its original bend acts in a direction that reduces the thickness of the mucosa 40. Therefore, the vascular network 42 in the submucosa collapses, and blood is expelled from the blood vessels, and hemoglobin is also expelled.

[0058] Therefore, when excitation light in the red to near-infrared wavelength range is irradiated to the outside (serosa side) of the hollow organ, the excitation light is absorbed by the fluorescent dye contained in the flexible resin forming the compression piece 20 with almost no inhibition of absorption by hemoglobin, and the fluorescent dye emits fluorescence in the red to near-infrared wavelength range. This fluorescence is also emitted to the outside of the hollow organ with almost no inhibition of absorption by hemoglobin. Therefore, this fluorescence can be clearly observed from the outside of the hollow organ, and the position of the clip 100 clamped inside the hollow organ can be determined, and the position of the affected area 41 can be identified.

[0059] In this case, as shown in Fig. 6D, the average thickness of the compression piece 20 in the observation direction of the clip 100 of this embodiment is contributed not only by the protruding portion 21 of the compression piece 20 but also by the back portion 22, the inner portion 23, and the inter-comb portion 25 filling the inter-comb space 7 of the compression piece. Therefore, according to the clip 100 of this embodiment, the fluorescence intensity observed from the outside of the hollow organ can be significantly increased compared to the case where a strip-shaped compression piece is attached to the tip end region of the arm parts 3a, 3b without forming the tip end region of the arm parts into a comb shape.

[0060] As a method of irradiating the serosal side of a hollow organ with excitation light, the serosal membrane of the hollow organ may be exposed by thoracic or abdominal incision and then irradiated with excitation light. Alternatively, a laparoscope (surgical endoscope) may be inserted through a hole made in the chest wall or abdominal wall, and the serosal or peritoneal surface of the hollow organ may be observed while excitation light in the red to near-infrared wavelength range is irradiated onto the serosal or peritoneal surface of the hollow organ.

[0061] In addition, when the fluorescence observed from the outside of the hollow organ is not visible light, the light-emitting site can be easily identified by observing it through a known infrared-to-visible conversion glass, or by photographing the hollow organ from the outside and visualizing the fluorescence by image processing.

[0062] The clip 100 of the present invention can be attached to the mucosa of the digestive tract, such as the esophagus, stomach, and large intestine, the tracheal mucosa, the bladder mucosa, the uterine mucosa, and the like, making it possible to reliably mark diseased areas of these hollow organs. [Explanation of symbols]

[0063] 1 Clip body 2 Fasteners (crimping rings) 3a, 3b Arm section 4 Continuous part 5. Arm tip region 6 Comb Teeth 7 Space between teeth 8 Hole 9 Side of arm 10 Claw part 12 Clamping surface 20 Compression Pad 21 Protruding part 22 Dorsal part 23 Inner part 24 Reinforcement part 25 Between the comb teeth 30 Clip sheath 31 Control wire 32 Connecting part 33 Inner sheath 34 Outer sheath 40 Mucosa 41 Affected area 42 Vascular network 100 Biocompression Comb Clip D1 Thickness of the protruding part of the compression piece D2 Thickness of the dorsal part of the compression piece L1 Protruding length of compression piece L2 Total length of compression piece W1 Width of clip body W2 Width of the protruding part of the compression piece X center axis

Claims

1. A clip having a clip body with an arm portion that clamps biological tissue, wherein the arm portion has a tip side region extending from the tip to the rear end in the longitudinal direction of the arm portion, which has a comb-like shape with multiple comb teeth arranged in parallel, the space between the comb teeth is not closed at the tip of the arm portion, and the tip side region of the arm portion has a compression piece protruding from the tip of the arm portion in the longitudinal direction of the arm portion, the compression piece being formed from an elastic, flexible resin and holding a fluorescent dye, wherein the compression piece bends when the arm portion clamps the biological tissue, and the compression piece compresses the biological tissue with an elastic force that tries to return to the original bend.

2. 2. The biocompression comb-tooth clip according to claim 1, wherein the clip body has a claw portion at the tip of the comb tooth that stands inward of the clip body, and the claw portion is arranged so as to be spaced away from the central axis of the clip body when the clip body is closed.

Citation Information

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