Slide stabbing clip

Abstract

To increase observation strength of fluorescent light from a fluorescent resin piece provided on a clip and also resolve fear of natural dropout of the clip, concerning the clip for holding a biological tissue.SOLUTION: A clip body 100 includes: a clip body 1 having a pair of metallic arm parts 2; and a fastener 20 which is fitted outside of the clip body 1. By the clip, the fastener 20 slides from near one end (proximal end) of the clip body 1 to the other end (distal end), and thereby the distal end of the clip body 1 is closed to hold a biological tissue. In the end on the distal end side of the arm parts 2, a resin piece 30 maintaining a fluorescent pigment (hereinafter called a fluorescent resin piece) is slidably provided for the arm parts 2. The fluorescent resin piece 30 is sharp-pointed in the distal end side end part 31 and, by the fastener 20 sliding from near the proximal end to the distal end of the arm parts 2, the fluorescent resin piece slides in the same direction as the fastener 20, with the distal end side end part 31 protruding from the distal end of the arm parts 2 to enable press fit into the biological tissue.SELECTED DRAWING: Figure 9E

Description

[Technical field]

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

[0002] In order to identify the location of the affected area during surgery, a metal clip is used that is attached to an endoscopic clip device and placed inside the body. For example, a metal clip body made of a metal leaf spring such as stainless steel formed into a V-shape and a fastener that fits onto the clip body are widely used, and when using the clip, the fastener is slid toward the distal end of the clip body so that the clip body clamps the biological tissue.

[0003] In such clips, it is desirable to be able to confirm the position of the clip clamping the mucosal tissue of the hollow organ from the serous membrane side.Therefore, the following have been proposed: forming the fastener of the clip from a resin (hereinafter also referred to as fluorescent resin) holding a fluorescent dye that emits red to near-infrared light when irradiated with excitation light (Patent Document 1), making a fluorescent resin piece protrude from the distal end of the clip body when the clip is used (Patent Document 2), making the fluorescent resin piece protrude from the distal end of the clip body and making the protruding part rotatable by a hinge (Patent Document 3), making an elastic fluorescent resin piece protrude from the distal end of the clip body, and compressing and collapsing the vascular network with the fluorescent resin piece while the clip body clamps the mucosal tissue (Patent Document 4), etc. [Patent Document 1] Patent No. 6161096 [Patent Document 2] Patent No. 7298596 [Patent Document 3] Patent Publication No. 2021-69802 [Patent Document 4] Patent No. 7162203 Summary of the Invention [Problem to be solved by the invention]

[0004] However, since the fastener of the clip described in Patent Document 1 is made of resin, it is difficult to increase the strength with which the clip body clamps biological tissue, compared to a clip using a metal fastener.

[0005] The clip described in Patent Document 2 uses a metal fastener, so the force with which the clip body clamps the mucosal tissue is stronger than that of the clip described in Patent Document 1. However, the fluorescent resin piece only clamps the mucosal tissue together with the clip body, and does not compress the mucosal tissue in its thickness direction. Therefore, blood from the vascular network in the mucosal tissue is not removed, and the blood significantly reduces the fluorescence intensity observed on the serosal side.

[0006] In the clip described in Patent Document 3, while the clip body is clamping the mucosal tissue, the fluorescent resin piece protruding from the clip body rotates on a hinge and is placed on the mucosal tissue. With this clip, the contact area between the fluorescent resin piece and the mucosal tissue can be increased. However, this fluorescent resin piece does not press the mucosal tissue in the thickness direction, and therefore the fluorescence intensity observed on the serosal membrane side is low, similar to the clip described in Patent Document 2.

[0007] According to the clip described in Patent Document 4, when the clip body clamps the mucosal tissue, the deformed fluorescent resin piece elastically compresses the mucosal tissue in its thickness direction, so that the fluorescence intensity observed on the serous membrane side is significantly stronger than that of the clips described in Patent Documents 2 and 3.

[0008] In contrast to such conventional technology, the objective of the present invention is to increase the fluorescence intensity observed on the serous membrane side to be equal to or greater than that of the clip described in Patent Document 4 by pressing the mucosal tissue in the thickness direction of the mucosal tissue with the clip body clamping the mucosal tissue, and to reliably eliminate the risk of the clip falling off naturally after the clip body clamps the mucosal tissue. [Means for solving the problem]

[0009] The present inventors have discovered that in a clip which comprises a clip body and a fastener fitted onto the clip body, and which, when in use, closes the distal end of the clip body by sliding the fastener from the proximal end to the distal end of the clip body to clamp biological tissue, if a fluorescent resin piece is slidably attached to the clip body and the distal end of the fluorescent resin piece is made sharply pointed, when the biological tissue is clamped by the clip body due to the sliding of the fastener, the fluorescent resin piece also slides and the sharply pointed distal end pierces and sinks into the biological tissue, and the sinking portion strongly compresses the biological tissue in the thickness direction, collapses the vascular network within the biological tissue, and prevents the clip from naturally falling off from the biological tissue, and have completed the present invention.

[0010] That is, the present invention provides a clip comprising a clip body having a pair of metal arms and a fastener fitted onto the clip body, the fastener sliding from one end (hereinafter also referred to as a proximal end) of the clip body to the other end (hereinafter also referred to as a distal end) of the clip body causing the distal end of the clip body to close and clamp biological tissue, a resin piece holding a fluorescent dye (hereinafter referred to as a fluorescent resin piece) is provided at a distal end of the arm portion so as to be slidable relative to the arm portion; The distal end of the fluorescent resin piece is sharply pointed, The fluorescent resin piece slides in the same direction as the fastener as the fastener slides from the proximal end to the distal end of the arm portion, and the distal end side end of the fluorescent resin piece protrudes from the distal end of the arm portion, providing a slide puncture clip that allows the fluorescent resin piece to be pressed into biological tissue. Effect of the Invention

[0011] According to the clip of the present invention, when the fastener is slid from the proximal end of the clip body to the distal end of the clip body to close the distal end of the clip body during use, the fluorescent resin piece also slides in the same direction as the fastener, and the distal end of the fluorescent resin piece protrudes from the distal end of the arm portion. Since the distal end of the fluorescent resin piece is formed in a sharp pointed shape, the fluorescent resin piece presses the biological tissue in the thickness direction of the biological tissue by sliding, and the sharp pointed tip of the fluorescent resin piece sinks into the biological tissue and continues to press the biological tissue. Therefore, the pressing force is concentrated on the sharp pointed recessed part, and the biological tissue is effectively compressed in the thickness direction. When the biological tissue is a mucous membrane, the sharp pointed tip of the fluorescent resin piece presses the mucous membrane in the thickness direction and sinks into the mucous membrane, and the pressure by the recessed part collapses the vascular network in the mucous membrane. In other words, blood is expelled from the vascular network. Therefore, when excitation light is irradiated onto the fluorescent resin piece on the serosal membrane side and the fluorescence emitted by the fluorescent resin piece is observed, the fluorescence intensity is significantly improved compared to when the mucosa is not compressed in the thickness direction, making it easy to confirm the position of the clip.

[0012] In addition, when the distal end of the clip body closes and the biological tissue is clamped by the clip body, the sharp tip of the fluorescent resin piece is pressed into the biological tissue, thereby eliminating the risk of the clip naturally falling off from the biological tissue compared to when the biological tissue is simply clamped by the clip body. [Brief description of the drawings]

[0013] [Figure 1A] FIG. 1A is a perspective view of an embodiment of a clip with the clip body in an open position. [Figure 1B] FIG. 1B is a side view of an example clip with the clip body in an open position. [Figure 1C] FIG. 1C is a top view of an example clip with the clip body in an open position. [Figure 2A] FIG. 2A is a perspective view of an embodiment of a clip with the clip body partially closed. [Figure 2B]FIG. 2B is a side view of an embodiment of a clip with the clip body partially closed. [Figure 3A] FIG. 3A is a perspective view of an embodiment of a clip with the clip body in a closed position. [Figure 3B] FIG. 3B is a side view of an example clip with the clip body in a closed position. [Figure 3C] FIG. 3C is a top view of an example clip with the clip body in a closed position. [Figure 4] FIG. 4 is an exploded view of the clip of the embodiment. [Diagram 5] FIG. 5 is a perspective view of a fluorescent resin piece used in the clip of the embodiment. [Figure 6] FIG. 6 is a top view, a side view, a front view, a rear view, and a bottom view of a fluorescent resin piece used in the clip of the embodiment. [Figure 7] FIG. 7 is an explanatory diagram of a method for attaching a fluorescent resin piece to a clip body in the clip of the embodiment. [Figure 8A] FIG. 8A is an explanatory diagram of a method of using the clip of the embodiment in an applier. [Figure 8B] FIG. 8B is an explanatory diagram of a method of using the clip of the embodiment in an applier. [Figure 8C] FIG. 8C is an explanatory diagram of a method of using the clip of the embodiment in an applier. [Figure 8D] FIG. 8D is an explanatory diagram of a method of using the clip of the embodiment in an applier. [Figure 9A] FIG. 9A is an explanatory diagram of the action of the clip of the embodiment on the mucosa. [Figure 9B] FIG. 9B is an explanatory diagram of the action of the clip of the embodiment on the mucosa. [Figure 9C] FIG. 9C is an explanatory diagram of the action of the clip of the embodiment on the mucosa. [Figure 9D] FIG. 9D is an explanatory diagram of the action of the clip of the embodiment on the mucosa. [Figure 9E] FIG. 9E is an explanatory diagram of the action of the clip of the embodiment on the mucosa. [Figure 10] FIG. 10 is a perspective view of a modified embodiment of the fluorescent resin piece of the clip according to the embodiment. [Figure 11] FIG. 11 is a perspective view of a modified embodiment of the fluorescent resin piece of the clip according to the embodiment. [Figure 12] FIG. 12 is a perspective view of a modified embodiment of the fluorescent resin piece of the clip according to the embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0014] 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.

[0015] <Overall composition of the clip> Figures 1A, 1B, and 1C are an oblique view, a side view, and a top view of a clip 100 of one embodiment of the present invention in an open state, Figures 2A and 2B are an oblique view and a side view of clip 100 in a state where it is closing, Figures 3A, 3B, and 3C are an oblique view, a side view, and a top view of clip 100 in a closed state, and Figure 4 is an exploded view of clip 100.

[0016] This clip 100 includes a clip body 1 having a pair of metal arm parts 2, a fastener 20 fitted onto the clip body 1, and a fluorescent resin piece 30 slidably provided on the distal end of each arm part 2 of the clip body 1. When using the clip 100, the fastener 20 is slid from the proximal end of the arm part 2 to the distal end, so that the fluorescent resin piece 30 slides in the same direction as the fastener 20, and the distal end of the fluorescent resin piece 30 protrudes from the distal end of the arm part. The distal end of the fluorescent resin piece 30 has a sharp pointed shape. This allows the distal end of the fluorescent resin piece protruding from the distal end of the arm part to puncture and sink into the biological tissue, and the sinking part can compress the biological tissue. The main configuration of this clip 100 is to make the fluorescent resin piece 30 slidable, to enable the fluorescent resin piece 30 to puncture and sink into the biological tissue by sliding, and to enable the sinking part to compress the biological tissue. Each part will be described below.

[0017] <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 2 obtained by bending a strip-shaped metal plate. The pair of arms 2 act as leaf springs.

[0018] The arm portion 2 has a narrow portion 4 near the proximal end when used to clip biological tissue, and a branched portion 5 near the distal end. At the proximal end, the pair of arm portions 2 are connected and curved into a U-shape. The operating wire of the applier is engaged with this connected portion 3.

[0019] 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. 6,572,229. As shown in FIG. 7 of Japanese Patent No. 6,694,893, 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. 4,145,149.

[0020] Meanwhile, at branch portion 5 near the distal end of arm portion 2, arm portion 2 is branched into two in a comb-like shape by a notch 6 (FIG. 4) extending in the longitudinal direction of arm portion 2. Note that in the present invention, the branch at branch portion 5 is not limited to two, and may be branched into three or more.

[0021] Furthermore, when the clip body 1 is in an open state (FIGS. 1A and 4), the pair of arms 2 are each curved toward the rear, and the distance between the distal ends of the pair of arms 2 becomes significantly wider.

[0022] (Claw part) The clip body 1 has claws 10 that stand up inwardly of the clip body 1 at the distal end of each arm portion 2 (FIG. 4). The claws 10 are the parts that directly bite into the biological tissue and hold it. In this embodiment, the claws 10 are triangular in shape to allow the claws 10 to easily bite into the biological tissue.

[0023] In the present invention, the claws 10 are not limited to a triangular shape, but may be rectangular. They may be triangular wave shapes formed by connecting triangular shapes, or rectangular wave shapes. However, it is preferable that the claws 10 are provided at positions away from the central axis X of the clip body 1 so that the distal end 31 of the fluorescent resin piece 30 can pass through the gap between the claws 10 when the clip body 1 is closed (FIG. 3C). Here, the central axis X of the clip body 1 is an axis that bisects the width W1 of the clip body in the top view of the clip body 1 (FIG. 3C) and is equidistant from the pair of arm portions 2 in the side view of the clip body 1 (FIG. 3B).

[0024] This makes it easy to slide fastener 20 to clamp the mucosa with clip body 1 by also sliding fluorescent resin piece 30 in the same direction as fastener 20, thereby pressing distal end portion 31 of fluorescent resin piece 30 against and puncturing the mucosa, and also prevents the fluorescence emitted from fluorescent resin piece 30 from being blocked by nail 10 when observation is performed by irradiating excitation light from the serosal membrane side, thereby improving the observable fluorescence intensity (Figure 9E).

[0025] In this embodiment, when the clip body 1 is closed, the claws 10 of the pair of arm portions 2 are shifted in the front-rear direction and overlap as shown in Fig. 3B. This allows the claws 10 to be spaced apart from the central axis X of the clip body 1 while being long enough to dig into biological tissue. If necessary, the tips of the claws 10 of the pair of arm portions 2 may be made to abut against each other.

[0026] <Fasteners> The fastener 20 is located near the proximal end of the clip body 1 to open the clip body 1 (FIG. 1A), and slides from the proximal end to the distal end, for example, to locate near the branched portion 5 of the arm portion 2 to close the clip body 1 (FIG. 3A), and is also called a crimping ring. The fastener 20 in this embodiment is formed of a metallic tubular member. The fastener 20 may be a coil of wire or a C-shaped cross section perpendicular to the longitudinal direction.

[0027] <Fluorescent resin piece> The fluorescent resin piece 30 is provided at the distal end of each arm portion 2 of the clip body 1 so as to be slidable relative to the arm portion 2. When the clip 100 is in use, the distal end portion 31 of the fluorescent resin piece 30 has a sharp pointed shape as shown in Figs. 5 and 6, and the fluorescent resin piece 30 has sufficient rigidity to puncture biological tissue. The fluorescent resin piece 30 is a resin piece that holds a fluorescent dye. Such a fluorescent resin piece 30 can be made of, for example, a hard plastic that contains a fluorescent dye. Alternatively, a coating film containing a fluorescent dye may be formed on the surface of a resin piece made of hard plastic.

[0028] (Details of the shape of the fluorescent resin piece) As shown in FIG. 1A, the fluorescent resin piece 30 of this embodiment has a shape that is provided along each arm portion 2 so as to sandwich the outer surface 2a and the inner surface 2b (FIG. 4) of each arm portion 2.

[0029] As shown in FIG. 1A, FIG. 5, and FIG. 6, the fluorescent resin piece 30 has an outer part 32 located on the outside of the arm part 2, an inner part 33 located on the inside of the arm part 2, and an intermediate part 34 connecting the outer part 32 and the inner part 33 in a region 35 near the distal end of the fluorescent resin piece 30. On the other hand, in a region 36 near the proximal end of the fluorescent resin piece 30, the outer part 32 and the inner part 33 are separated, allowing the base part 5a (FIG. 4) of the branched part of the arm part 2 to enter into this gap. The distal end side end part 31 of the fluorescent resin piece 30 is formed in an acute pointed shape. The acute pointed shape does not need to be a shape that can puncture biological tissue, and is preferably a shape that can push biological tissue with a sharp and thin tip, and it is preferable that the distal end tip angles θ1, θ2, and θ3 of the fluorescent resin piece 30 are acute angles in all of the top view, side view, and bottom view of the fluorescent resin piece 30 shown in FIG. 6.

[0030] 3C, when clip body 1 is in a closed state, the outer shape of outer portion 32 in a top view overlaps the outer shape of branched portion 5 of arm portion 2. Because width w1 of fluorescent resin piece 30 in a top view (i.e., width of outer portion 32) is equal to or smaller than the width of branched portion 5 of arm portion 2, the tip of fluorescent resin piece 30 can be pressed into biological tissue to cause the tip to sink into the biological tissue, making it easy for the sinking portion to compress and collapse the vascular network inside the biological tissue.

[0031] When the clip body 1 is closed, the length L1 of the clip body 1 can be similar to that of a typical clip used as a marker, and the length L2 of the fluorescent resin piece protruding from the clip body is preferably 1 to 4 mm from the standpoint of the effect of compressing the submucosal tissue and collapsing the blood vessels.

[0032] Furthermore, as shown in Figures 2A and 2B, the shape of the fluorescent resin piece 30 is such that when the pair of arms 2 of the clip body 1 are partially closed, the tips of the opposing distal ends 31 abut against each other. However, when the fastener 20 is abutted against the fluorescent resin piece and further slid as shown in Figures 3A and 3B to completely close the pair of arms 2 (i.e., when the fastener 20 does not easily return toward the proximal end of the clip body 1), a gap s1 is preferably formed between the sharp tips of the fluorescent resin pieces 30 of each arm portion 2. As a result, when clip 100 is pulled into outer sheath 54 as shown in Fig. 8B, outer parts 32 of fluorescent resin pieces 30 are pressed by the inner peripheral surface of outer sheath 54 and clip body 1 begins to close, the sharp pointed tips of opposing fluorescent resin pieces 30 come into contact with each other, but a gap s2 is created near the proximal end (Figs. 2B and 8B), and then fastener 20 can be slid to the vicinity of base 5a (Fig. 4) of the branched part of clip body 1 so that clip body 1 is completely closed. Then, when clip 100 is completely closed, the above-mentioned gap s1 is created (Figs. 3B and 8D).

[0033] In contrast, when the clip 100 is pulled into the outer sheath 54 and the outer portion 32 of the fluorescent resin piece 30 is pressed against the inner surface of the outer sheath 54, if there is no gap s2 near the proximal end of the inner portion 33 of the opposing fluorescent resin piece 30, it may not be possible to slide the fastener 20 until the clip body 1 is completely closed.

[0034] The intermediate portion 34 has a width w2 that fits into the gap between the claws 10 of each arm portion 2, and the width w3 of the inner portion 33 is greater than the width w2 of the intermediate portion 34 and smaller than the width w1 of the outer portion 32 (FIG. 6). As a result, a groove 37 is formed along the side surface of the intermediate portion 34 at the side edge of the fluorescent resin piece 30. This groove 37 slidably engages with the comb-tooth-shaped portion of the arm portion branched at the branch portion 5.

[0035] An acute angle portion 38 is formed on the distal end surface of the groove 37. This acute angle portion 38 has a barbed structure that makes it difficult for the fluorescent resin piece, which has been punctured into the biological tissue, to come out of the biological tissue.

[0036] In the present invention, the barb structure is not limited to this, and may be provided at or near the distal end of the fluorescent resin piece 30 so as not to interfere with the use of the clip in an endoscopic clip device (applier). For example, as shown in Fig. 10, a step 39 may be provided on the side of the fluorescent resin piece 30 at the position of the acute angle 38 described above, as shown in Fig. 11, a step 40 may be provided on the outer surface of the distal end 31 of the fluorescent resin piece 30, or as shown in Fig. 12, a horn-shaped portion 41 may protrude from the outer surface of the distal end 31 of the fluorescent resin piece 30. The proximal end surface 41a of this horn-shaped portion 41 is recessed.

[0037] Meanwhile, protruding portions 42 that sandwich narrow portion 4 of arm portion 2 are provided at both ends on the proximal end side of fluorescent resin piece 30 (FIGS. 1A and 2A). This makes it possible to prevent fluorescent resin piece 30 from coming off arm portion 2 even when fluorescent resin piece 30 is slid on arm portion 2.

[0038] (Resin that forms the fluorescent resin pieces) Examples of resins that can be used to form the fluorescent resin pieces 30 include hard resins used in medical devices, such as high-density polyvinyl chloride, thermoplastic polyurethane, silicone, ethylene-vinyl acetate copolymer, and polycarbonate. The hardness of the fluorescent resin piece 30 is preferably A90 or more as measured by a durometer according to Shore A (JIS K 6253).

[0039] (Fluorescent dye) The fluorescent dye held in the fluorescent resin piece 30 is preferably one that emits fluorescence in the red light to near-infrared light wavelength region of 600 to 1400 nm, preferably in the red light or near-infrared light wavelength region of 700 to 1100 nm. Light in this wavelength region 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.

[0040] 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.

[0041] Specific examples of how to retain a fluorescent dye in the fluorescent resin piece 30 include incorporating the fluorescent dye into the resin that forms the fluorescent resin piece 30, or forming a coating film containing the fluorescent dye on the surface of the molded resin piece.

[0042] When a fluorescent dye is contained in the resin forming the fluorescent resin piece 30, 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.

[0043] As a method for incorporating the fluorescent dye into the resin, for example, the fluorescent dye may be kneaded into the resin using a twin-screw kneader.

[0044] If necessary, a contrast agent such as barium sulfate may be added to the resin forming the fluorescent resin piece 30. This makes it possible to track the clip 100 inside the living body by photographing it with X-rays, even if the clip 100 becomes detached from the mucous membrane inside the living body. (Method of forming fluorescent resin pieces) The fluorescent resin piece 30 can be formed, for example, by molding a flexible resin mixed with a fluorescent dye into a predetermined shape by extrusion molding or injection molding, and then cutting it to a specified length, removing corners, forming recesses, etc.

[0045] (How to attach the fluorescent resin piece to the clip body) As a method of attaching the fluorescent resin piece 30 to the clip body 1, for example, as shown in FIG. 7, while bending the convex portion 42 side of the fluorescent resin piece 30, the base 5a of the branched portion 5 of the arm portion 2 is inserted into the space between the outer portion 32 and the inner portion 33, and further the middle portion 34 is fitted into the notch 6 of the branched portion 5, so that the narrow portion 4 of the arm portion 2 is sandwiched between the convex portion 42 of the fluorescent resin piece 30 (FIG. 1A).

[0046] <How to use the clip> As a method of using the clip 100, first, as shown in FIG. 8A, the clip 100 is attached to a clip sheath 50 of an endoscopic applier. As the clip sheath 50, for example, one having an inner sheath 53, an outer sheath 54, and an operation wire 51 as 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 50, for example, the connecting portion 52 of the operation wire 51 may be hooked to the rear end portion (continuous portion 3) of the clip main body 1. In addition, when the clip main body 1 is formed from a leaf spring bent into a V-shape, U-shape, etc., a hook may be used as described in Japanese Patent No. 5781347, etc.

[0047] When the clip 100 is retracted into the outer sheath 54 by operating the applier, the clip body 1 closes as shown in Fig. 8B. When the clip body 1 is protruded from the outer sheath 54, the distal end of the clip body 1 opens as shown in Fig. 8C. When the inner sheath 53 is brought into contact with the fastener 20 and the operating wire 51 is retracted to slide the fastener 20 toward the distal end of the clip 100, the clip body 1 gradually closes, and finally the clip body 1 is completely closed as shown in Fig. 8D. When the fastener 20 slides from the proximal end toward the distal end of the clip body 1, the fluorescent resin piece 30 is pushed by the fastener 20, so that the fluorescent resin piece 30 also slides in the same direction, and the distal end 31 of the fluorescent resin piece 30 protrudes from the distal end of the arm portion 2 as shown in Fig. 8D.

[0048] A case where such an opening and closing mechanism of the clip 100 is used to clamp an affected part of the mucosa of a hollow organ with the clip 100 will be described. The clip body 1 is attached to the operating wire 51, the clip 100 is retracted into the outer sheath 54, and the clip sheath 50 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 54, and the distal end of the arm part 2 of the clip body 1 is opened near the affected part 61 (FIG. 9A). Next, the clip 100 is brought into contact with the mucosa 60, and the fastener 20 is slid toward the distal end by retracting the operating wire. The clip body 1 closes according to the amount of movement at this time (FIGS. 9B and 9C). After the fastener 20 comes into contact with the fluorescent resin piece 30 by sliding, the fastener 20 presses the fluorescent resin piece 30 toward the distal end of the clip body (FIG. 9D). Thus, when the clip body 1 is in a completely closed state, the mucosa 60 is clamped by the claws 10 at the distal ends of the arms 2, and the mucosa 60 is also clamped by the inner part 33 of the fluorescent resin piece 30. Furthermore, the acutely pointed distal end 31 of the fluorescent resin piece 30 is pressed into the mucosa 60, so that it sinks into the mucosa, and the mucosa 60 is compressed in a direction that makes the thickness of the mucosa 60 thinner by the pressure of the sinking part. Therefore, the vascular network 62 in the submucosa collapses, and blood is expelled from the blood vessels, and hemoglobin is also expelled. In addition, once the fluorescent resin piece 30 punctures the mucosa, the acute angled part 38 (Fig. 5) functions as a barb, making it difficult for the fluorescent resin piece 30 to come out of the mucosa.

[0049] Therefore, when excitation light in the red to near-infrared wavelength range is irradiated onto the outside (serosa side) of the hollow organ, the excitation light is absorbed by the fluorescent dye held in the fluorescent resin piece 30. At this time, there is almost no inhibition of absorption by hemoglobin. The fluorescent dye that absorbs the excitation light 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, with this clip 100, the fluorescence can be observed well from the outside of the hollow organ, the position of the clip 100 clamped inside the hollow organ can be determined, and the position of the affected area 61 can be identified.

[0050] Furthermore, with the clip 100 of this embodiment, the mucosa 60 is clamped by the claws 10 of the arms 2 and also by the inner part 33 of the fluorescent resin piece 30, and furthermore, the acute angled part 38 of the fluorescent resin piece 30 makes it difficult for the fluorescent resin piece 30 to come off the mucosa 60. Therefore, the risk of the clip 100 accidentally falling off the mucosa 60 can be greatly reduced.

[0051] As a method for irradiating the serosal side of a hollow organ with excitation light, the serosal membrane of the hollow organ may be exposed by opening the chest or abdomen 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 excitation light in the red to near-infrared wavelength range may be irradiated onto the serosal or peritoneal surface of the hollow organ while observing the serosal or peritoneal surface of the hollow organ.

[0052] Furthermore, 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 through image processing.

[0053] 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]

[0054] 1 Clip body 2 Arm section 2a Outer surface of arm 2b Inner surface of arm 3 Continuous part 4 Narrow part 5 Branching section 5a Base of branch 6 Notch 10 Claws 20 Fasteners 30 Fluorescent resin piece 31 Distal end 32 Outer part 33 Inner part 34 Middle section 35 Distal end region 36 Proximal end region 37 Groove 38 Sharp corner 39 steps 40 steps 41 Angular part 41a Proximal end surface 42 Convex 50 Sheath 51 Control wire 52 Connecting part 53 Inner sheath 54 Outer sheath 60 Mucosa 61 Affected area 62 Vascular network 100 Clips L1 Length of clip body L2: Length of the fluorescent resin piece protruding from the clip body s1, s2 gap w1: Width of the outer part of the fluorescent resin piece, width as viewed from above w2 Width of the middle part of the fluorescent resin piece w3 Width of the inner part of the fluorescent resin piece X Central axis of clip body

Claims

1. The clip comprises a clip body having a pair of metal arms and a fastener fitted onto the clip body, and the fastener slides from one end (hereinafter also referred to as a proximal end) of the clip body to the other end (hereinafter also referred to as a distal end) of the clip body, thereby closing the distal end of the clip body and clamping biological tissue, a resin piece carrying a fluorescent dye (hereinafter referred to as a fluorescent resin piece) is provided at a distal end of the arm portion so as to be slidable relative to the arm portion; The distal end of the fluorescent resin piece is sharply pointed, This slide puncture clip allows the fluorescent resin piece to slide in the same direction as the fastener as the fastener slides from the proximal end to the distal end of the arm portion, and the distal end side end of the fluorescent resin piece protrudes from the distal end of the arm portion, enabling it to be pressed into biological tissue.

2. 2. The clip according to claim 1, wherein a fluorescent resin piece is provided along each arm portion so as to sandwich the outer and inner surfaces of each arm portion.

3. 3. A clip according to claim 1 or 2, wherein a groove for engaging with the arm portion is provided on a side edge of the fluorescent resin piece.

4. 4. The clip according to claim 3, wherein the arm portion has a branched portion near a distal end, the branched portion engaging with a groove in the fluorescent resin piece.

5. 3. The clip according to claim 1, wherein the arm portion has a narrow portion closer to the proximal end than the branch portion, and the fluorescent resin piece has protrusions on both sides of the proximal end side of the fluorescent resin piece that sandwich the narrow portion of the arm portion.

6. 3. The clip according to claim 1, wherein the fluorescent resin piece is provided with a barb structure that makes it difficult for the fluorescent resin piece pressed into the biological tissue to come out of the biological tissue.

7. 3. The clip according to claim 1, wherein the clip body has inwardly extending tabs at the distal ends of the arms.

Images