Indwelling clip
By designing an endogenous placement fixture with fluorescent material, using its elastically openable clamp and hook-shaped end design, the problem of difficulty in external observation of the fluorescence of the inner wall of the fixture in the prior art is solved, and efficient fluorescence observation and fixture adhesion stability are achieved.
Patent Information
- Application Number
- JP2025017799
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2018-03-30
- Filing Date
- 2025-02-05
- Publication Date
- 2025-04-11
AI Technical Summary
In the prior art, it is difficult to effectively observe fluorescence on the inner wall of the endogenous placement fixture from the outside, and the clamp's adhesion stability on the inner wall is insufficient.
An endogenous placement fixture is designed, including a flexible opening V-shaped clamp, a clamp end with a hooked end, and a clamp end with an outer surface covering fluorescent material. The fixture is transmitted to the intestine through the endoscope and fixture device, and when the inner wall is attached, the fluorescent material is close to the inner wall, reducing fluorescence attenuation, and improving the attachment stability of the fixture through a metal fastening ring.
The fluorescence on the inner wall of the fixture is clearly observed from the outside, and the fixture is highly stable when attached to the inner wall of the intestinal tract, avoiding the problem of loose fixtures.
Smart Images

Figure 2025062109000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to an in vivo clip that can be inserted into a lumen using, for example, an endoscope and can be used as a marker whose position can be visually recognized from outside the lumen. [Background technology]
[0002] In general, diseases such as cancer of the digestive tract, such as the esophagus, stomach, and large intestine, develop and progress mainly in the mucous membrane of the digestive tract. Similarly, lung cancer develops mainly in the tracheal mucosa, and bladder cancer develops and progresses mainly in the bladder mucosa. Therefore, in order to confirm the diagnosis of diseases of hollow organs such as the digestive tract, trachea, and bladder, it is essential to insert an endoscope into the hollow organ to observe the mucosa and biopsy the affected tissue. Then, based on the confirmed diagnosis, the affected tissue is surgically resected as necessary.
[0003] However, in surgical resection, the surgeon approaches the luminal organ from the outside, and therefore cannot directly see the affected area. In other words, when observing the digestive tract, lungs, or bladder with the naked eye or laparoscope during thoracotomy, laparotomy, or laparoscopic surgery, what is seen is not the mucosa, but the serous surface of the digestive tract, the serous surface of the trachea, or the peritoneal surface of the bladder. Therefore, it is necessary to attach a marker to the inside of the luminal organ so that the resection area can be determined even when observing the luminal organ from the outside.
[0004] As such a marker, a surgical marker has been proposed that is placed adjacent to a clip that engages with the mucous membrane inside the body and consists of an LED that emits near-infrared light or an illuminator made of a fluorescent substance (Patent Document 1).
[0005] However, among the above-mentioned surgical markers, markers that use LEDs as light-emitting bodies require a power supply, which makes the device configuration complicated, and it is difficult to form the marker compact enough to pass through the treatment tool guide tube of an endoscope.Furthermore, among the above-mentioned surgical markers, those that use light-emitting bodies formed from fluorescent substances are said to emit fluorescence when excitation light is irradiated from the outside of the hollow organ, and do not require a power supply to emit the fluorescence, but the intensity of the fluorescence emitted to the outside (serosa side) of the hollow organ is weak, and in practice, it is difficult to visually recognize the light-emitting site from the outside of the hollow organ.
[0006] As an improvement over the above-mentioned drawbacks of surgical markers, Patent Document 2 proposes a biocompression clip that includes a clip body having an arm portion and a tubular member fastened to the clip body so that the arm portion can be closed, and the tubular member is provided with a pressing portion that presses the mucosa (inner wall of a hollow organ) and contains a fluorescent dye that emits red or near-infrared light. In this clip, the pressing portion containing the fluorescent dye is attached to the inner wall of the hollow organ while pressing the wall of the hollow organ, so that the attenuation of the fluorescence when passing through the wall of the hollow organ (especially the hemoglobin contained in the blood) is kept to a minimum, and as a result, even when the fluorescence is observed from the outside of the hollow organ, the light-emitting site can be clearly seen. However, in the clip shown in Patent Document 2, the tubular member (tightening ring) for closing the arm portion is made of a resin material containing a fluorescent dye, so that the tightening of the arm portion to the inner wall of the hollow organ by the arm portion is easily loosened, and there is a demand for improving the attachment stability of the clip body. [Prior art documents] [Patent documents]
[0007] [Patent Document 1] JP 2005-218680 A [Patent Document 2] International Publication No. 2015 / 182737 Summary of the Invention [Problem to be solved by the invention]
[0008] The present invention has been made in consideration of these points, and aims to provide an in-vivo clip that allows the emission of fluorescent material to be easily observed from outside the hollow organ and has excellent attachment stability to the inner wall of the hollow organ. [Means for solving the problem]
[0009] The in vivo clip according to the present invention comprises: A pair of arm plate parts that open in a generally V-shape by elasticity; a claw portion formed at each tip of the arm plate portion; a clamping ring attached to the pair of arm plate portions so as to be movable along a longitudinal direction of the pair of arm plate portions, and closing the pair of arm plate portions by moving the clamping ring in the direction of the claw portion, The present invention is characterized in that at least one of the claw portions has an outer surface provided with a phosphor containing a fluorescent dye that emits red or near-infrared light when irradiated with excitation light.
[0010] The in vivo retention clip of the present invention is delivered to the inside of a hollow organ using, for example, an endoscope and a clipping device, and attached to the inner wall of the hollow organ. When the clip is attached, the fluorescent material provided on the outer surface of the claw part of the clip body is pressed against the inner wall of the hollow organ.
[0011] Therefore, according to the in vivo retention clip of the present invention, the attenuation of the fluorescence when passing through the wall of the hollow organ is kept to a minimum, and the emission of the fluorescent material is easily visible from outside the hollow organ. Also, since the fastening ring that closes the arm plate part does not need to be made of a fluorescent material, there are no restrictions on the design of the fastening ring, and the clip can be attached stably to the inner wall of the hollow organ. The emission of the fluorescent material from outside the hollow organ can be visually recognized by image recognition using an imaging device such as a laparoscope, or by visual inspection, depending on the wavelength of the light, etc.
[0012] The phosphor may protrude from the claw to the outside of the arm plate. Also, the phosphor may protrude from the claw toward the tip. Furthermore, the phosphor may be provided continuously from the outer surface of the claw to the outer surface of the arm plate. Furthermore, the tightening ring may be made of metal. [Brief description of the drawings]
[0013] [Figure 1] FIG. 1 is a perspective view showing the overall configuration of an in-vivo retention clip according to an embodiment of the present invention with arm plate portions in an open position. [Diagram 2] FIG. 2 is a perspective view showing a state in which the arm plate portions of the clip in FIG. 1 are closed. [Figure 3A] FIG. 3A is a diagram showing the appearance of a clip device according to an embodiment of the present invention. [Figure 3B] FIG. 3B is a cross-sectional view taken along line IIIB-IIIB in FIG. 3A. [Figure 4A] 4A shows the clip of FIG. 1 protruding from the distal end of the clipping device of FIG. 3A. [Figure 4B] FIG. 4B illustrates the clip of FIG. 1 received in the distal end of the clipping device of FIG. 3A. [Diagram 5] FIG. 5 is a schematic diagram showing the state in which the clip of FIG. 1 is placed in a hollow organ. [Figure 6A] FIG. 6A is a perspective view showing the overall configuration of an in-vivo indwelling clip according to another embodiment of the present invention with the arm plate portions in an open position. [Figure 6B] FIG. 6B is a perspective view showing a state in which the arm plate portions of the clip in FIG. 6A are closed. [Figure 6C] FIG. 6C is a schematic diagram showing the state in which the clip of FIG. 6A is placed inside the body. [Figure 7] FIG. 7 is a perspective view showing the overall configuration of an in-vivo indwelling clip according to still another embodiment of the present invention with the arm plate portions in an open position. [Figure 8]FIG. 8 is a perspective view showing the overall configuration of an in-vivo indwelling clip according to still another embodiment of the present invention with the arm plate portions in an open position. [Figure 9] FIG. 9 is a perspective view showing the overall configuration of an in-vivo indwelling clip according to still another embodiment of the present invention with the arm plate portions in an open position. [Figure 10] FIG. 10 is a perspective view showing a state in which the arm plate portions of the clip in FIG. 9 are closed. [Figure 11] FIG. 11 is a schematic diagram showing the state in which the clip of FIG. 9 is placed in a hollow organ. [Figure 12] FIG. 12 is a perspective view showing the overall configuration of an in-vivo indwelling clip according to still another embodiment of the present invention with the arm plate portions in an open state. [Figure 13] FIG. 13 is a perspective view showing a state in which the arm plate portions of the clip in FIG. 12 are closed. [Figure 14] FIG. 14 is a perspective view showing the overall configuration of the clip body shown in FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0014] Hereinafter, an embodiment of the present invention will be described in detail with reference to the drawings.
[0015] (First embodiment) First, a first embodiment of the present invention will be described with reference to Figures 1 to 5. As shown in Figure 1, an in-vivo retention clip 1 of this embodiment is used as a marker that is attached to the inner wall of a hollow organ in a living body and whose position can be visually confirmed from outside the lumen, and has a clip body 2 and a fluorescent substance 3.
[0016] The clip body 2 includes a connecting plate portion 21, a pair of arm plate portions 22, and a fastening ring 24. The connecting plate portion 21 has a shape bent into a substantially U-shape, and arm plate portions 22, 22 are integrally formed so as to continue to each end of the U-shape and open toward the tip side in a substantially V-shape.
[0017] The fastening ring 24 is a member formed in a ring shape that is slidably fitted onto the connecting plate portion 21 on the base end side of the arm plate portion 22. The fastening ring 24 is a member that is slid using an inner sheath 52 shown in Fig. 3A described later and a clip device 5 that is arranged to be freely advanced and retreated relative to the inner sheath 52 and has a connecting hook 51 that is detachably (disengageably) connected (engaged) to the connecting plate portion 21. The fastening ring 24 shown in Figs. 1 and 2 is pushed by the distal end of the inner sheath 52 to slide, closing the arm plate portion 22, by retracting the connecting hook 51 shown in Fig. 3A from the tip end of the inner sheath 52 into the inside as shown in Fig. 4B in a state in which the connecting hook 51 shown in Fig. 3A is connected to the connecting plate portion 21.
[0018] 1, a claw portion 23 is integrally formed at the tip of each arm plate portion 22. Claw portion 23 is bent inward (i.e., in the closing direction) at the tip of arm plate portion 22. Each claw portion 23 has a recessed notch portion 23a in the middle portion of its tip.
[0019] The connecting plate portion 21, the pair of arm plate portions 22, and the pair of claw portions 23 are formed by bending a single thin, elongated plate material. The plate material constituting these is not particularly limited in thickness, but is preferably 0.10 to 0.30 mm. As the plate material, a metal plate having elasticity is preferable, for example, a stainless steel plate is used. In this embodiment, the fastening ring 24 is also made of metal, and the material is not particularly limited, and it may be made of the same metal (for example, stainless steel) as the plate material constituting the arm plate portion 22, etc., or may be made of a metal different from the plate material constituting the arm plate portion 22, etc., such as a titanium alloy, gold, aluminum, etc.
[0020] Each arm plate 22 has a base end 22a and a gripping portion 22b. A through hole 22c is formed in the gripping portion 22b of each arm plate 22. These through holes 22c are formed without impairing the desired strength of the arm plate 22 (grip portion 22b). These through holes 22c are formed from the viewpoint of adjusting the elasticity (repulsive force) when the arm plate 22 is closed by the tightening ring 24.
[0021] The fastening ring 24 slidably fitted in the connecting plate portion 21 is composed of a substantially cylindrical ring member. However, the fastening ring 24 may be composed of a spring formed by winding a wire in a coil shape. The fastening ring 24 is attached (fitted) so that the connecting plate portion 21 is inserted into a guide hole on the inside of the fastening ring 24 and can move (slide) in the axial direction between the outer periphery of the connecting plate portion 21 and the outer periphery of the base end portion 22a of the arm plate portion 22. As shown in FIG. 2, a stopper projection 21a is formed on the connecting plate portion 21 so that the fastening ring 24 does not come off the outside of the connecting plate portion 21.
[0022] As shown in Fig. 1, when the fastening ring 24 is disposed toward the rear of the arm plate portion 22 (connecting plate portion 21), the arm plate portion 22 is in an open (spread-legged) state due to its own elasticity. If necessary, the arm plate portion 22 can be put into a closed (closed-legged) state by moving (sliding) the fastening ring 24 to a position toward the tip end of the base end portion 22a (toward the grip portion 22b) as shown in Fig. 2.
[0023] 1, the outer surface of at least one of the claws 23 is provided with phosphor 3 containing a fluorescent dye that emits red or near-infrared light when irradiated with excitation light. The pair of claws 23 can be interlocked, and it is preferable that at least the phosphor 3 is attached to the outer surface of the claw 23 located on the outside when they are interlocked. The phosphor 3 is attached to the outer surface of the claw 23 by adhesion, insert molding, or the like.
[0024] In this embodiment, the shape of the phosphor 3 is the same as the outer surface shape of the claw portion 23, but may be different. The phosphor 3 is preferably formed from a polymer material composition containing a fluorescent dye. The fluorescent dye is preferably one that emits fluorescence in the red to near-infrared wavelength range of 600 to 1400 nm. Light in such a wavelength range is highly permeable to human tissues such as skin, fat, and muscle, and can easily reach up to about 5 mm to 20 mm below the surface of the tissue of the living body.
[0025] Fluorescent dyes that emit fluorescence in the above-mentioned wavelength range include water-soluble dyes such as riboflavin, thiamine, NADH (nicotinamide adenine dinucleotide), and indocyanine green (ICG). Examples of suitable dyes include oil-soluble dyes such as the azo-boron complex compound described in JP 2011-162445 A. Among these, dyes that are highly compatible with polymeric materials are preferred because they are stably retained in the polymeric materials without dissolving in the body, and the azo-boron complex compound described in JP 2011-162445 A is particularly preferred because it has excellent fluorescence emission intensity, compatibility with polymeric materials such as polyurethane, light resistance, and heat resistance.
[0026] A preferred concentration of the fluorescent dye in the polymeric material composition containing the fluorescent dye varies depending on the type of the fluorescent dye and the polymeric material used as a binder, but is usually preferably 0.1 to 0.001% by mass.
[0027] Examples of polymeric materials that can be used to incorporate fluorescent dyes include polyurethane, polypropylene, polyethylene, polyvinyl chloride, polyamide, polyamide elastomer, etc., with a hardener added as required.
[0028] As a method for incorporating the fluorescent dye into the polymeric material, for example, a method of kneading the fluorescent dye into the polymeric material using a twin-screw kneader can be mentioned. After that, the polymeric material is molded into a predetermined shape by extrusion molding or injection molding, and post-processed as necessary to obtain the phosphor 3. The phosphor 3 is fixed to the outer surface of the claw portion 23 by means of adhesion, insert molding, or the like.
[0029] A contrast agent such as barium sulfate may be added to the polymeric material composition containing the fluorescent dye, if necessary. This makes it possible to track the fluorescent substance 3 inside the hollow organ by photographing it with X-rays, even if the in-vivo retention clip 1 that has been clamping the inner wall of the hollow organ in the living body becomes detached from the inner wall of the hollow organ, or the fluorescent substance 3 falls off from the clip body 2.
[0030] The phosphor 3 may be formed by coating the outer surface of the claw portion 23 of the clip body 2 with paint containing a fluorescent dye. The phosphor 3 may be formed by coating the outer surface of a plate material formed of a polymeric material composition containing a fluorescent dye with a transparent material not containing a fluorescent dye or by forming a double layer. The phosphor 3 may be formed by fixing a fluorescent dye to the surface of a plate material formed of a material not containing a fluorescent dye with gelatin or the like. The thickness of the phosphor 3 is determined so as to obtain sufficient fluorescent properties, and is not particularly limited, but is preferably 1 to 5000 μm.
[0031] In this embodiment, for example, an endoscope as shown in Fig. 5 and a clipping device 5 as shown in Fig. 3A are used to deliver the in-vivo retention clip 1 to the inside of the hollow organ 4 as shown in Fig. 5, and the clip 1 is attached to a specific position on the inner wall of the hollow organ 4. For example, the clip is attached around a tumor 4b occurring in a part of the mucosa (inner wall of the hollow organ) 4a present on the inner wall of the hollow organ 4 in order to identify its position. Either a single clip 1 or multiple clips 1 may be attached to the inner wall of the hollow organ 4, but multiple clips are preferably used.
[0032] Here, a clipping device 5 shown in FIG. 3A will be described, which is used to deliver the in-vivo retention clip 1 into the body via a treatment tool guide tube of an endoscope 6 shown in FIG. 5 and to grasp and retain (clip) tissue in the body.
[0033] The clip device 5 has a connecting hook 51 , an inner sheath 52 , a driving wire 53 , an outer sheath 54 , a reinforcing coil 55 , a first slider portion 56 , a base portion 57 , and a second slider portion 58 .
[0034] 3B, a tubular inner sheath 52 is inserted into a tubular outer sheath 54, and a driving wire 53 is inserted into the inner sheath 52. The inner sheath 52 is slidable within the outer sheath 54, and the driving wire 53 is slidable within the inner sheath 52.
[0035] The outer sheath 54 is made of a flexible hollow tube, and in this embodiment, a coil tube is used. As the coil tube, a flat wire coil tube made by spirally winding a long flat plate made of metal (stainless steel) or the like can be used. However, a round wire coil tube or an inner flat coil tube may also be used. The inner diameter of the tip of the outer sheath 54 is about 2 to 3 mm.
[0036] The inner sheath 52 is made of a flexible hollow tube, and in this embodiment, a wire tube is used. The wire tube is a tube made of a hollow stranded wire obtained by helically twisting a plurality of wires (cables) made of metal (stainless steel) or the like to form a hollow space. Note that the inner sheath 52 may be mainly made of a wire tube, with only a portion of the tip side being a coil tube. The inner diameter of the tip of the inner sheath 52 is about 1.5 to 2.5 mm.
[0037] The driving wire 53 is made of a flexible wire, and in this embodiment, a wire rope is used. The wire rope is a rope made of strands of wires that are formed by helically twisting a plurality of wires (cables) made of metal (stainless steel) or the like. However, a wire tube similar to the inner sheath 52 may also be used as the driving wire 53.
[0038] 3A, a connecting hook 51 disposed at the distal end of the clip device 5 has a pair of arms 51a, 51a made of an elastic body arranged in a substantially V-shape toward its tip, and can assume two states, an open leg state and a closed leg state, in cooperation with an inner sheath 52. The tips of the arms 51a, 51a of the connecting hook 51 are bent inward (toward each other) to form claws, which enable the connecting plate portion 21 of the clip body 2 to be grasped and connected.
[0039] The base end of the connecting hook 51 is a U-shaped portion that is connected to the base ends of the pair of arms 51a, 51a and is formed into a substantially U-shape. The connecting hook 51 can be formed by appropriately bending (plastically deforming) a single elongated plate material made of an elastic body. Although not particularly limited, the plate material constituting the connecting hook 51 has a thickness of about 0.20 to 0.24 mm and a width of about 0.6 mm. As the plate material, for example, stainless steel is used.
[0040] The base end of the connecting hook 51 is fixed by laser welding or the like to the tip (distal end) of the driving wire 53 which is slidably inserted into the inner sheath 52. The connecting hook 51 may be made swivellable relative to the driving wire 53 by fixing a substantially annular member to the distal end of the driving wire 53 by laser welding or the like and passing the U-shaped portion of the connecting hook 51 through this circular member.
[0041] The vicinity of the base end (proximal end) side of the outer sheath 54 is inserted into the reinforcing coil 55 and is fixed integrally to the reinforcing coil 55. The reinforcing coil 55 is fixed integrally to a first slider portion 56, and a distal end side portion of the base portion 57 is inserted and disposed inside the first slider portion 56. The first slider portion 56 is slidable relative to the base portion 57 so as to be positionable between a position moved to the tip end (distal end) side and two positions moved to the base end (proximal end) side.
[0042] A second slider portion 58 is slidably held on the base portion 57, and the inner sheath 52 is fixed to the base portion 57. The proximal end of the drive wire 53 is fixed to the second slider portion 58.
[0043] When the second slider portion 58 is slid toward the tip side (distal end side) relative to the base portion 57, the inner sheath 52 is drawn into the driving wire 53, and the connecting hook 51 at the tip of the driving wire 53 protrudes from the tip of the inner sheath 52 and opens due to its own elasticity. When the second slider portion 58 is slid toward the base end side (proximal end side) relative to the base portion 57, the driving wire 53 is drawn into the inner sheath 52, and the connecting hook 51 at the tip of the driving wire 53 enters the inner sheath 52 and gradually closes, and is buried in the inner sheath 52 to completely close.
[0044] When the first slider portion 56 is slid to a base end position relative to the base portion 57, the inner sheath 52 can be protruded from the tip of the outer sheath 54, and conversely, when the first slider portion 56 is slid to a tip end position relative to the base portion 57, the tip of the inner sheath 52 can be stored (embedded) in the outer sheath 54.
[0045] Next, an example of a method of using the in-vivo retention clip 1 will be described with reference to Figures 4A, 4B, and 5. The connection hook 51 of the clip device 5 is engaged with the connection hole 25 formed on the inside of the connection plate portion 21 of the clip body 2, and the connection hook 51 is pulled into the inside of the inner sheath 52, whereby the connection hook 51 closes and the clip body 2 of the in-vivo retention clip 1 is attached to the tip of the inner sheath 52 (see Figure 4A).
[0046] In this state, the distal end of the inner sheath 52 to which the in-vivo retention clip 1 (clip body 2 and phosphor 3) is connected is pulled into the outer sheath 54, and the entire in-vivo retention clip 1 is housed inside the distal end of the outer sheath 54 (see FIG. 4B). In this state, the fastening ring 24 of the clip body 2 is located at the connecting plate portion 21, and the arm plate portions 22 are closed by the action of the inner wall of the outer sheath 54.
[0047] Using an endoscope 6 shown in Fig. 5, the distal end of the outer sheath 54 of the clip device 5 to which the in-vivo retention clip 1 is attached is inserted into the hollow organ 4. Next, the outer sheath 54 shown in Fig. 3A is slid toward the proximal end, causing the in-vivo retention clip 1 to protrude from the distal end of the outer sheath 54. This causes the arm plate portions 22 to open due to their own elasticity, as shown in Fig. 4A.
[0048] With the arm plates 22 in an open state, they are positioned around a lesion such as a tumor 4b shown in Fig. 5. Next, the inner sheath 52 shown in Fig. 4A is slid toward the distal end relative to the driving wire 53, causing the tightening ring 24 to slide toward the tip of the arm plate 22. As a result, the arm plates 22 gradually close (come closer to each other), and a part of the mucosa 4a is sandwiched.
[0049] The inner sheath 52 is further slid toward the distal end relative to the driving wire 53, the fastening ring 24 is moved toward the tip end of the arm plate portion 22, and the clip body 2 of the in-vivo clip 1 is completely closed. In this state, the inner sheath 52 is slid toward the proximal end relative to the driving wire 53, and the connecting hook 51 is pushed out from the distal end of the inner sheath 52 to open the legs, and the grip (engagement) of the connecting hook 51 of the clip body 2 is released. This completes clipping of a portion of the mucosa 4a by the in-vivo clip 1, as shown in FIG. 5.
[0050] Next, the clip device 5 is removed from the endoscope, and another separately prepared in-vivo retention clip 1 is attached to the distal end of the clip device 5 (or a separately prepared clip device having the same configuration as the clip device 5). Next, the distal end of the clip device 5 to which the other in-vivo retention clip 1 is attached is transported to the vicinity of a site located on the opposite side of the tumor 4b. Then, a part of the mucosa 4a can be clipped with the clip 1 in the same manner as described above. In this manner, multiple clips 1 can be clipped to the mucosa 4a located around the tumor 4b.
[0051] In this embodiment, the in-vivo retention clip 1 is delivered to the inside of the hollow organ 4 using the endoscope 6 shown in FIG. 5 and the clip device 5 shown in FIG. 3A, and the clip 1 is attached to a specific position. When the clip 1 is attached, the phosphor 3 provided on the outer surface of the claw portion 23 of the clip body 2 is pressed against the mucous membrane 4a of the inner wall of the hollow organ 4. In the portion where the phosphor 3 is pressed, the vascular network below the mucous membrane 4a is compressed, and blood can be removed from the blood vessels. As a result, when excitation light is irradiated from the outside (serosa side) of the hollow organ 4 to the inside (mucosa side) during thoracotomy or laparotomy or laparoscopic surgery, it is less likely to be absorbed by hemoglobin contained in the blood of the vascular network below the mucosa, and the excitation light can easily reach the phosphor 3 provided on the outer surface of the claw portion 23.
[0052] The phosphor 3 provided on the outer surface of the claw portion 23 contains a fluorescent dye that emits red or near-infrared light when irradiated with excitation light. Therefore, the excitation light irradiated from outside the hollow organ 4 is efficiently absorbed by the fluorescent dye of the phosphor 3 without being absorbed by hemoglobin, and the fluorescence emitted from the fluorescent dye of the phosphor 3 is also emitted to the outside of the hollow organ 4 without being absorbed by hemoglobin. Therefore, the emission of the phosphor 3 attached to the mucosa 4a of the hollow organ 4 can be easily visually recognized from the outside of the hollow organ 4. In addition, since the fastening ring 24 is made of metal, the fastening of the in-vivo retention clip 1 is unlikely to loosen, and the attachment stability of the clip 1 is improved. The light emission from the fluorescent substance 3 from outside the tubular organ 4 can be visually recognized by selecting a means that makes it easy to visually recognize the fluorescence without being affected by the excitation light, depending on the wavelength of the excitation light and the wavelength of the fluorescence. For example, this can be achieved by image recognition using an imaging device such as a laparoscope equipped with a near-infrared camera or a medical near-infrared camera system, or by visual inspection.
[0053] During thoracotomy or laparotomy or laparoscopic surgery, if the fluorescent material 3 emits light due to excitation light irradiated from the outside of the hollow organ 4, the light emitted by the fluorescent material 3 can be visually observed or imaged by an imaging device, for example, to identify the position of the fluorescent material 3 from the outside of the hollow organ 4, and from there, the position of the lesion such as the tumor 4b can be identified. Therefore, the hollow organ 4 corresponding to the tumor 4b can be excised from the outside using a normal scalpel or a high-frequency knife, with only the minimum necessary area. The clip 1 can also be removed from the body together with the excision of the tumor 4b.
[0054] Second embodiment Next, a second embodiment of the present invention will be described with reference to Figures 6A to 6C. Note that the description will focus on changes from the first embodiment described with reference to Figures 1 to 5.
[0055] 6A to 6C, the in vivo retention clip 1a of this embodiment is similar to the in vivo retention clip 1 of the first embodiment, except that the shape and configuration of the phosphor 3a are changed. That is, in this embodiment, the clip body 2 is similar to the clip body 2 of the first embodiment, and only the phosphor 3a differs from the phosphor 3 of the first embodiment in that a protrusion 30 that protrudes from the claw portion 23 to the outside of the arm plate portion 22 is integrally formed on the phosphor 3a.
[0056] The protrusions 30 are provided on each phosphor 3a, and protrude from the boundary between the claw portion 23 and the arm plate portion 22 of the clip body 2 in a direction away from the clip body 2 toward the outside of the arm plate portion 22 so as to extend the outer surface of the claw portion 23. The protrusions 30 are formed integrally with the phosphor 3a, and are made of, for example, a polymer material composition containing a fluorescent dye.
[0057] In this embodiment, the in-vivo retention clip 1a is delivered to the inside of the hollow organ 4 using the endoscope 6 shown in FIG. 5 and the clip device 5 shown in FIG. 3A, and the clip 1a is attached to a specific position. When the clip 1a is attached, the tip of the claw 23 of the clip body 2 bites into the mucous membrane 4a of the inner wall of the hollow organ 4, and the phosphor 3a provided on the outer surface of the claw 23 is pressed against the mucous membrane 4a. In the part where the phosphor 3a is pressed, the vascular network below the mucous membrane 4a is compressed, and blood can be removed from the blood vessels. As a result, when excitation light is irradiated from the outside (serosa side) of the hollow organ 4 to the inside (mucosa side) during thoracotomy or laparotomy or laparoscopic surgery, it is difficult for the excitation light to be absorbed by hemoglobin contained in the blood of the vascular network below the mucosa, and the excitation light can easily reach the phosphor 3a provided on the outer surface of the claw 23. In particular, in this embodiment, the area of the phosphor 3a is increased by the presence of the protrusion 30, and the fluorescent area is large, so that the light due to the fluorescence is particularly easy to view. The rest is the same as the first embodiment described above.
[0058] Third embodiment Next, a third embodiment of the present invention will be described with reference to Fig. 7. Note that the description will focus on changes from the first embodiment described with reference to Figs. 1 to 5.
[0059] 7, the in vivo retention clip 1b of this embodiment is similar to the in vivo retention clip 1 of the first embodiment, except that the shape and configuration of the phosphor 3b are changed. That is, in this embodiment, the clip body 2 is similar to the clip body 2 of the first embodiment, and only the phosphor 3b differs from the phosphor 3 of the first embodiment in that the phosphor 3b has a claw-shaped protrusion 32 integrally formed therewith, protruding from the claw portion 23 toward the tip of the claw portion 23.
[0060] The claw-shaped protrusions 32 are provided on each phosphor 3b and protrude from the tip of the claw portion 23 of the clip body 2 along the outer surface of the claw portion 23 in a direction away from the claw portion 23, with their tips formed sharply. The claw-shaped protrusions 32 are formed integrally with the phosphor 3b and are made of, for example, a polymer material composition containing a fluorescent dye.
[0061] In this embodiment, the in-vivo retention clip 1b is delivered to the inside of the tubular organ 4 using the endoscope 6 shown in FIG. 5 and the clip device 5 shown in FIG. 3A, and the clip 1b is attached to a specific position. When the clip 1b is attached, the tip of the claw portion 23 of the clip body 2 together with the claw-shaped protrusion 32 bites into the mucous membrane 4a of the inner wall of the tubular organ 4, and the phosphor 3b provided on the outer surface of the claw portion 23 is pressed against the mucous membrane 4a. In the part where the phosphor 3b is pressed, the vascular network below the mucous membrane 4a is compressed, and blood can be removed from the blood vessels. As a result, when excitation light is irradiated from the outside (serosa side) of the tubular organ 4 to the inside (mucosa side) during thoracotomy or laparotomy or laparoscopic surgery, it is difficult for the excitation light to be absorbed by hemoglobin contained in the blood of the vascular network below the mucosa, and the excitation light can easily reach the phosphor 3b provided on the outer surface of the claw portion 23. In particular, in this embodiment, the area of the phosphor 3b is increased by the presence of the claw-shaped protrusions 32, and the fluorescent area is large, so that the light due to the fluorescence is particularly easy to view. The rest is the same as the first embodiment described above.
[0062] (Fourth embodiment) Next, a fourth embodiment of the present invention will be described with reference to Fig. 8. Note that the description will focus on changes from the first embodiment described with reference to Figs. 1 to 5.
[0063] 8, the in vivo retention clip 1c of this embodiment is similar to the in vivo retention clip 1 of the first embodiment, except that the shape and configuration of the phosphor 3c are changed. That is, in this embodiment, the clip body 2 is similar to the clip body 2 of the first embodiment, and only the phosphor 3c differs from the phosphor 3 of the first embodiment in that the phosphor 3c has an extension 34 formed continuously from the outer surface of the claw portion 23 to the outer surface of the arm plate portion 22 integrally formed therewith.
[0064] The extension 34 is formed on each phosphor 3a and is formed continuously from the outer surface of the claw portion 23 to the outer surface of the gripping portion 22b of the arm plate portion 22, and a part of the inner surface of the extension 34 may enter inside the through hole 22c formed in the arm plate portion 22. By having a part of the extension 34 enter inside the through hole 22c, the phosphor 3c is less likely to fall off from the clip body 2, which is preferable. The extension 34 is formed integrally with the phosphor 3c and is made of, for example, a polymer material composition containing a fluorescent dye. The extension 34 may also be formed on the inside of the arm plate portion 22.
[0065] In this embodiment, the in-vivo retention clip 1c is delivered to the inside of the hollow organ 4 using the endoscope 6 shown in FIG. 5 and the clip device 5 shown in FIG. 3A, and the clip 1c is attached to a specific position. When the clip 1c is attached, the tip of the claw portion 23 of the clip body 2 together with the extension portion 34 bites into the mucous membrane 4a of the inner wall of the hollow organ 4, and the phosphor 3c provided on the outer surface of the claw portion 23 is pressed against the mucous membrane 4a. In the part where the phosphor 3c is pressed, the vascular network below the mucous membrane 4a is compressed, and blood can be removed from the blood vessels. As a result, when excitation light is irradiated from the outside (serosa side) of the hollow organ 4 to the inside (mucosa side) during thoracotomy or laparotomy or laparoscopic surgery, it is difficult for the excitation light to be absorbed by hemoglobin contained in the blood of the vascular network below the mucosa, and the excitation light can easily reach the phosphor 3c provided on the outer surface of the claw portion 23. Particularly in this embodiment, the area of the phosphor 3c is increased by the presence of the extension 34, and the fluorescent area is large, so that the light due to the fluorescence is particularly easy to view. The rest is the same as the first embodiment described above.
[0066] Fifth embodiment Next, a fifth embodiment of the present invention will be described with reference to Figures 9 to 11. Note that the description will focus on changes from the fourth embodiment described with reference to Figure 8.
[0067] As shown in Fig. 9, the in-vivo retention clip 1d of this embodiment has a phosphor 3d_1. The phosphor 3d_1 differs from the phosphor 3c of the fourth embodiment in that it has a tip protrusion 35_1. The phosphor 3d_1 is provided on a claw portion 23 formed on the tip portion of one of the pair of arm plate portions 22, 22. In this embodiment, the in-vivo retention clip 1d is provided with phosphors 3d_2 and 3d_3 in addition to the phosphor 3d_1.
[0068] The phosphor 3d_3 is made of a flat plate-like phosphor. The phosphor 3d_3 is attached to the inner surface of each of the pair of arm plate portions 22 (the gripping portion 22b), and the gripping portion 22b is sandwiched between the phosphor 3d_3 and the phosphor 3d_1 (3d_2).
[0069] The phosphor 3d_2 is provided on the other arm plate portion 22 of the pair of arm plate portions 22, 22. A tip protrusion 35_2 is integrally formed on the phosphor 3d_2 provided on the other arm plate portion 22. The tip protrusion 35_2 has a protruding shape and protrudes outward from the tip of the arm plate portion 22 (grip portion 22b).
[0070] The tip protrusion 35_2 is made of a flat plate-like phosphor and is tapered in the width and thickness directions toward the tip. Therefore, the tip protrusion 35_2 has excellent piercing properties, and when the clip 1d is attached to the inner wall of the hollow organ 4, the tip protrusion 35_2 can be easily inserted into the mucous membrane 4a of the inner wall of the hollow organ 4.
[0071] The thickness of the tip protrusion 35_2 is approximately the same as or thicker than the thickness of the phosphor 3c shown in the fourth embodiment. Therefore, the tip protrusion 35_2 has sufficient strength, and when the clip 1d is attached to the inner wall of the hollow organ 4, the tip protrusion 35_2 can be inserted into the mucous membrane 4a of the inner wall of the hollow organ 4 without bending.
[0072] The tip protrusion 35_2 protrudes along the longitudinal direction of the arm plate portion 22, and the ratio L1 / L of the protrusion length L1 from the tip of the arm plate portion 22 to the total length L of the phosphor 3d_2 is preferably 0.15 to 0.50. The same applies to the tip protrusion 35_1, and the protrusion lengths of the tip protrusion 35_1 and the tip protrusion 35_2 are approximately equal.
[0073] 10, the phosphor 3d_1 is provided on the claw portion 23 that is disposed on the outside when the pair of arm plate portions 22, 22 are closed. A tip protrusion 35_1 is integrally formed with the phosphor 3d_1 provided on this claw portion 23. The tip protrusion 35_1 has a protruding shape and protrudes outward from the tip of the arm plate portion 22 from the outer surface of the claw portion 23 (or from the tip of the arm plate portion 22 (grip portion 22b)).
[0074] The shape of the tip protrusion 35_1 corresponds to the shape of the outer surface of the claw portion 23, and a part (side portion 36) of the tip protrusion 35_1 protrudes in the extension direction of the claw portion 23. Most of the claw portion 23 is covered by one end of the side portion 36 of the tip protrusion 35_2.
[0075] The length L2 of the side portion 36 along the extending direction of the claw portion 23 is approximately the same as or shorter than the length along the extending direction of the claw portion 23. Therefore, when the pair of arm plate portions 22, 22 are closed, the tip protrusion 35_1 does not come into contact with the tip protrusion 35_2, and clipping by the clip 1d is not hindered by the tip protrusions 35_1, 35_2.
[0076] Moreover, the length L2 becomes shorter toward the tip of the phosphor 3d_1, and the tip protrusion 35_1 as a whole becomes thinner toward the tip. Therefore, the tip protrusion 35_1 has excellent piercing properties, and when the clip 1d is attached to the inner wall of the hollow organ 4, the tip protrusion 35_1 can be easily inserted into the mucous membrane 4a of the inner wall of the hollow organ 4.
[0077] The tip protrusion 35_1 has a recessed notch 35a formed in the middle of its tip. However, if the claw portion 23 does not have the notch 23a (see FIG. 9), the notch 35a may be omitted.
[0078] The tip protrusion 35_1 is curved (bent) in the width direction so that its shape (cross-sectional shape) is substantially C-shaped. The tip protrusion 35_1 is made of a phosphor having a larger volume (or area) than the tip protrusion 35_2. Therefore, the fluorescence intensity of the tip protrusion 35_1 is greater than the fluorescence intensity of the tip protrusion 35_2.
[0079] The outer surfaces of the phosphors 3d_1, 3d_2 are curved along the width direction of the phosphors 3d_1, 3d_2 (same as the width direction of the arm plate portion 22) from the viewpoint of making it easier to accommodate the entire clip 1d inside the distal end of the outer sheath 54 of the clip device 5 (see Figure 4B).
[0080] In this embodiment, the in-vivo retention clip 1d is also carried to the inside of the hollow organ 4 using the endoscope 6 shown in Fig. 5 and the clip device 5 shown in Fig. 3A, and the clip 1d is attached to a specific position. When the clip 1d is attached, the tip projections 35_1, 35_2 together with the tips of the claws 23 of the clip body 2 bite into the mucous membrane 4a of the inner wall of the hollow organ 4, and the tip projections 35_1, 35_2 (particularly, the most distal ends of the tip projections 35_1, 35_2) are pressed against the mucous membrane 4a. In the portion where the tip projections 35_1, 35_2 are pressed, the vascular network below the mucous membrane 4a is compressed, and blood can be removed from the blood vessels. As a result, when excitation light is irradiated from the outside (serosa side) of the hollow organ 4 toward the inside (mucosa side) during thoracotomy or laparotomy or laparoscopic surgery, the excitation light is less likely to be absorbed by hemoglobin contained in the blood of the vascular network of the submucosa, and the excitation light is more likely to reach the tip protrusions 35_1, 35_2 of the phosphors 3d_1, 3d_2 and the phosphors 3d_1, 3d_2 provided on the outer surface of the arm plate portion 22. Particularly in this embodiment, the area of the phosphor 3d_1 is increased due to the presence of the tip protrusion 35_1, and the fluorescent area is large, so that the light due to the fluorescence is particularly easy to view. The rest is the same as the above-mentioned fourth embodiment.
[0081] In this embodiment, the pair of arm plate portions 22, 22 are provided with the phosphors 3d_1, 3d_2, respectively. Therefore, as shown in Fig. 11, when the phosphors 3d_1 and 3d_2 are inserted into the mucous membrane 4a of the inner wall of the hollow organ 4, the clip 1d is prevented from falling to one side of the pair of arm plate portions 22, 22, and the clip 1d can be maintained in a state in which it is erected substantially perpendicular to the mucous membrane 4a.
[0082] Sixth embodiment Next, a sixth embodiment of the present invention will be described with reference to Fig. 12 to Fig. 14. Note that the description will focus on changes from the fourth embodiment described with reference to Fig. 8.
[0083] As shown in Fig. 12, the in vivo retention clip 1e of this embodiment has a clip body 2' and a phosphor 3e. The phosphor 3e differs from the phosphor 3c of the fourth embodiment in that it has a tip protrusion 35e. As shown in Fig. 14, the clip body 2' has an arm plate portion 22' in addition to the arm plate portion 22.
[0084] Arm plate portion 22' differs from arm plate portion 22b in that it has grip portion 22b'. Grip portion 22b' has recessed notch 25 formed in the middle of its tip, and does not have claw portion 23 at its tip.
[0085] In this embodiment, when the phosphor 3e is formed by injection molding or the like, the gripping portion 22b' of the arm plate portion 22' is integrated with the phosphor 3e by insert molding or the like. As shown in Fig. 12, the phosphor 3e has a tip protrusion 35e, which differs from the tip protrusion 35_2 shown in Fig. 9 in that it has a claw-shaped portion 37.
[0086] The tip protrusion 35e protrudes from the tip of the arm plate 22' in the longitudinal direction of the arm plate 22', and the ratio L3 / L of the protrusion length L3 to the total length L of the phosphor 3e is preferably 0.15 to 0.50.
[0087] The claw-shaped portion 37 is formed from a part of the tip protrusion 35e and is integrally formed at the tip of the tip protrusion 35e. As shown in Fig. 13, when the pair of arm plates 22, 22' are closed, the claw-shaped portion 37 is disposed outside the claw portion 23 formed on one of the arm plates 22. Note that the claw-shaped portion 37 may be formed from the entire tip protrusion 35e.
[0088] The claw-shaped portion 37 is bent at a predetermined angle with respect to the extending direction of the tip protrusion 35e, and extends inward (i.e., in the closing direction of the pair of arm plate portions 22, 22'). The thickness of the claw-shaped portion 37 is approximately the same as or thicker than the thickness of the phosphor 3c shown in the fourth embodiment. The claw-shaped portion 37 has a recessed notch 37a in the middle of its tip.
[0089] The claw-like portion 37 has a shape corresponding to the claw portion 23 formed at the tip of the arm plate 22, and plays the same role as the claw portion 23. That is, in this embodiment, the claw portion 23 is substituted for the claw portion 23 in one arm plate 22'. As a result, when the pair of arm plates 22, 22' are closed, the claw portion 23 formed at the tip of the arm plate 22 engages with the claw-like portion 37 of the phosphor 3e provided on the arm plate 22', making it possible for the claw portion 23 and the claw-like portion 37 to grip the mucous membrane 4a on the inner wall of the tubular organ 4.
[0090] 12, in this embodiment, a portion of the phosphor 3e is also provided on the inner surface of the arm plate portion 22' (grip portion 22b'), and the outer and inner surfaces of the grip portion 22b' are covered with the phosphor 3e. A portion of the phosphor 3e formed on the inner surface of the grip portion 22b' is connected to the lower surface of the tip protrusion 35e.
[0091] The phosphor 3e shown in Fig. 12 fits into the inside of the notch 25 of the gripping portion 22b' shown in Fig. 14. Therefore, the phosphor 3e is firmly fixed to the gripping portion 22b', and it is possible to prevent the phosphor 3e from falling off (slipping off) from the gripping portion 22b'.
[0092] In this embodiment, the in-vivo retention clip 1e is also delivered to the inside of the tubular organ 4 using the endoscope 6 shown in FIG. 5 and the clip device 5 shown in FIG. 3A, and the clip 1e is attached to a specific position. When the clip 1e is attached, the tip of the claw 23 of the clip body 2' and the claw-like portion 37 of the phosphor 3e bite into the mucous membrane 4a of the inner wall of the tubular organ 4, and the tip protrusion 35e (particularly the claw-like portion 37 of the tip protrusion 35e) is pressed against the mucous membrane 4a. In the portion where the tip protrusion 35e is pressed, the vascular network below the mucous membrane 4a is compressed, and blood can be removed from the blood vessels. As a result, when excitation light is irradiated from the outside (serosa side) of the tubular organ 4 to the inside (mucosa side) during thoracotomy or laparotomy or laparoscopic surgery, it is less likely to be absorbed by hemoglobin contained in the blood of the vascular network below the mucosa, and the excitation light can easily reach the tip protrusion 35e of the phosphor 3e. Particularly in this embodiment, the area of the phosphor 3e is increased by the presence of the claw-shaped portions 37, and the fluorescent area is large, so that the light due to the fluorescence is particularly easy to view. The rest is the same as in the above-mentioned fourth embodiment.
[0093] Furthermore, in this embodiment, by forming the phosphor 3e by injection molding or the like, it is possible to increase the freedom of design of the phosphor 3e and the clip body 2' (particularly, the gripping portion 22b'), for example by forming a claw-shaped portion 37 from a part of the tip protrusion 35e or by introducing a shape (notch portion 25) that has an anti-slip effect into the gripping portion 22b'.
[0094] The present invention is not limited to the above-described embodiment, and can be modified in various ways. For example, the elements disclosed in the above-described embodiment can be modified and combined in various ways. Furthermore, the biological tissues in which the in-vivo retention clips of the above-described embodiment can be used are not particularly limited, and examples include hollow organs such as the digestive tract, trachea, bladder, bile duct, pancreatic duct, ureter, renal duct, liver, kidney, and lung. Furthermore, the in-vivo retention clip of the present invention can be used for purposes other than surgery to resect a part of a hollow organ.
[0095] In the sixth embodiment, the phosphor 3e is integrated with the gripping portion 22b' of the arm plate portion 22' by insert molding, but the phosphor 3e may be fixed to the gripping portion 22b' by means of adhesion or the like.
[0096] In the sixth embodiment, the phosphor may be engaged in the through hole 22c formed in the arm plate portion 22. In this case, the entire through hole 22c does not have to be covered with the phosphor, and for example, only the vicinity of the periphery of the through hole 22c may be covered with the phosphor.
[0097] In the sixth embodiment, the shape of the grip portion 22b' of the arm plate portion 22' is not particularly limited and may be changed as appropriate. For example, the grip portion 22b' may be formed with a notch 25 that narrows toward the tip side of the grip portion 22b'. [Explanation of symbols]
[0098] 1, 1a, 1b, 1c, 1d, 1e...Intravital clip 2,2'…Clip body 21...Connection plate part 21a... Stopper protrusion 22,22'...Arm plate section 22a...Proximal end 22b, 22b'...Gripping part 22c...Through hole 23…Claw part 23a…Notch 24…Tightening ring 25…Notch 3,3a,3b,3c,3d_1,3d_2,3d_3,3e...phosphor 30...Protrusion 32...Claw-shaped protrusion 34...Extension part 35_1,35_2,35e...Tip protrusion 35a…Notch 36...lateral part 37…Claw-shaped part 37a…Notch 4…luminal organs 4a…Mucous membrane 4b…Tumor 5...Clip device 51…Connecting hook 51a…Arm section 52…Inner sheath 53...Drive wire 54…Outer sheath 55…Reinforcing coil 56…First slider part 57…Base section 58…Second slider part 6. Endoscope
Claims
1. A pair of arm plate portions that open in a generally V-shape by elasticity; The in vivo retention clip is made of a metal plate and has a clip body having a claw portion formed at each end of the arm plate portion, a phosphor containing a fluorescent dye that emits red or near infrared light when irradiated with excitation light is provided on an outer surface of at least one of the claw portions; The in vivo clip is characterized in that the fluorescent substance is an extrusion or injection molded product of a polymer material composition containing the fluorescent dye.
2. The in-vivo clip according to claim 1 , wherein the phosphor protrudes from the claw portion to the outside of the arm plate portion.
3. 3. The in vivo clip according to claim 1, wherein the fluorescent material is provided continuously from the outer surface of the claw portion to the outer surface of the arm plate portion.
Citation Information
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