Internally placed medical device and endoscope system using same

Abstract

To provide an indwelling type medical device that can acquire near-infrared light from the entire device by partially using near-infrared fluorescent material.SOLUTION: An indwelling type medical device includes: a first assembly formed of a first material including a fluorescent dye that emits near infrared light; and a second assembly formed of a second material reflecting near infrared light and reflecting the near infrared light that is emitted from the first assembly.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present disclosure relates to an indwelling medical device and an endoscopic system using the same. [Background technology]

[0002] Near-infrared light and near-infrared fluorescence penetrate biological tissues, and are therefore attracting attention as light for visualizing the inside of living organisms, such as lymphatic vessels, blood vessels, and organs. Indocyanine green (ICG) has traditionally been used as a near-infrared fluorescent dye. When ICG is irradiated with near-infrared light, the ICG molecules are excited and emit near-infrared fluorescence with a wavelength slightly longer than that of the irradiated near-infrared light.

[0003] A configuration has been proposed in which an ICG mixed solution is injected into a balloon catheter to inflate the balloon, and the position of the balloon is confirmed by capturing an image of the fluorescence from the ICG (see, for example, Patent Document 1). ICG has low heat resistance and is structurally unstable, making it difficult to knead it into resins, etc. Also, there are cases in which sufficient fluorescent brightness cannot be obtained.

[0004] There is a known method for producing urinary catheters and other molded articles by kneading a near-infrared fluorescent dye other than ICG into a polymer or resin (see, for example, Patent Documents 2 and 3). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] JP 2018-143667 A [Patent Document 2] JP 2014-136116 A [Patent Document 3] JP 2016-192997 A Summary of the Invention [Problem to be solved by the invention]

[0006] Depending on the type of resin into which the near-infrared fluorescent material is kneaded, the required fluorescent properties may not be obtained. For example, a typical Foley catheter with a balloon is made of silicone or latex, but even if the near-infrared fluorescent material described in Patent Documents 2 or 3 is kneaded into these resin materials, almost no fluorescence is obtained. On the other hand, there are situations where light from the balloon is necessary. This is because the balloon shape is visualized by fluorescence, making it possible to confirm the position of the organ in which the balloon is placed, and to observe and operate on organs in the vicinity of the balloon. If near-infrared light could be obtained from the entire device, not only for balloon catheters but also for general medical devices placed in the body, without applying expensive near-infrared fluorescent materials to the entire device, it would be possible to observe the entire device while reducing costs.

[0007] An object of the present disclosure is to provide a medical device to be placed within the body that can obtain near-infrared light from the entire device without using a near-infrared fluorescent material throughout the entire device. [Means for solving the problem]

[0008] In one aspect of the embodiment, a medical device for placement within the body has a first assembly formed of a first material containing a fluorescent dye that emits near-infrared light, and a second assembly formed of a second material that reflects near-infrared light and reflects the near-infrared light emitted from the first assembly. Effect of the Invention

[0009] This makes it possible to realize an indwelling medical device that can emit near-infrared light from the entire device without using a near-infrared fluorescent material for the entire device. [Brief description of the drawings]

[0010] [Figure 1] FIG. 1 is a schematic diagram of a balloon catheter, which is an example of the intracorporeal indwelling medical device of the first embodiment. [Diagram 2] FIG. 2 is a schematic cross-sectional view of an example of the configuration of a catheter tube used in the balloon catheter of FIG. 1. [Diagram 3] This is a near-infrared image of the balloon catheter that was actually manufactured. [Figure 4] The first comparative example is a near-infrared image taken when a balloon that does not contain a reflective material is used. [Diagram 5] As a second comparative example, this is a near-infrared image when the balloon contains a reflective material, but the catheter tube inside the balloon is covered with a near-infrared shielding film. [Figure 6] 1 is a near-infrared image of another balloon catheter. [Figure 7] FIG. 2 is a schematic diagram showing an example of use of the balloon catheter of the first embodiment. [Figure 8] FIG. 11 is a schematic diagram of a catheter tube set which is an example of the intracorporeal indwelling medical device of the second embodiment. [Figure 9] FIG. 11 is a diagram showing the setup for Experiment 1 for investigating reflection of near-infrared fluorescence in the second embodiment. [Figure 10] FIG. 1 is a diagram showing the specifications of a catheter tube set used in Experiment 1. [Figure 11A] This is an image taken when the near-infrared light was turned off in Experiment 1. [Figure 11B] This is an image taken when near-infrared light was turned on in Experiment 1. [Figure 12] FIG. 13 is a diagram showing specifications of a catheter tube set used in Experiment 2 of the second embodiment. [Figure 13A] This is an image taken when the near-infrared light was turned off in Experiment 2. [Figure 13B] This is an image taken when near-infrared light was turned on in Experiment 2. [Figure 14] FIG. 11 is a schematic diagram of an endoscopic clip set, which is an example of a medical device to be placed within the body according to a third embodiment. [Figure 15] 15 is a schematic diagram showing an example of use of the endoscopic clip set of FIG. 14. [Figure 16] FIG. 1 is a schematic diagram of an endoscope system using an indwelling medical device. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] Hereinafter, embodiments of the present disclosure will be described with reference to the drawings. In the drawings, the same components are denoted by the same reference numerals, and duplicated descriptions may be omitted.

[0012] In an embodiment, a near-infrared fluorescent dye is applied to a first assembly included in the indwelling device, and a near-infrared fluorescent dye is not added to a second assembly disposed near the first assembly. The second assembly is formed of a material including a reflective substance that reflects near-infrared fluorescence from the first assembly. When the indwelling medical device is irradiated with excitation light, the first assembly emits near-infrared fluorescence, and the second assembly reflects the near-infrared fluorescence from the first assembly. This allows fluorescence to be obtained from the entire indwelling medical device even if a near-infrared fluorescent dye is not added to the second assembly.

[0013] First Embodiment FIG. 1 is a schematic diagram of a balloon catheter 10, which is an indwelling medical device of a first embodiment. The balloon catheter 10 has a catheter tube 11 and a balloon 12 provided on the outer periphery of the catheter tube 11. The catheter tube 11 is an example of a first assembly, and is formed of a material containing a near-infrared fluorescent dye. The balloon 12 is an example of a second assembly, and does not contain a near-infrared fluorescent dye. The balloon 12 contains a substance that reflects near-infrared fluorescence from the catheter tube.

[0014] 1, the balloon 12 is depicted in an inflated state, but before the balloon catheter 10 is used, the balloon 12 in a deflated state is provided on the outer periphery of the catheter tube 11. The balloon 12 is inflated after the catheter tube 11 is inserted to a predetermined position inside the body.

[0015] The catheter tube 11 is a resin tube in which a near-infrared fluorescent dye is kneaded. Examples of resin materials that can be used include polyurethane resin, polyamide resin, polyethylene resin, and fluororesin. The surfaces of these resins may be coated with a hydrophilic coating that is transparent to near-infrared light. Depending on the area where the balloon catheter 10 is used, materials with relatively high rigidity, such as polypropylene resin and polycarbonate resin, may also be used.

[0016] As the near-infrared fluorescent dye to be kneaded into the resin, a known near-infrared fluorescent material can be used. For example, the dyes described in Patent Document 2 or Patent Document 3 may be used. Specifically, dyes such as polymethylene, phthalocyanine, naphthoquinone, anthraquinone, dithiol metal complex salt, azo, and triarylmethane can be used. In practice, the suitability of the combination of the resin and the near-infrared fluorescent dye used depends on the suitability, and a fluorescent dye that can obtain near-infrared fluorescence with sufficient brightness can be selected according to the resin material used.

[0017] In the embodiment, as an example, polyurethane resin is used as the resin material of the catheter tube 11, and among the above dyes, a near-infrared fluorescent dye that is heat resistant and can be kneaded with polyurethane resin is used. This near-infrared fluorescent dye has fluorescent properties similar to those of the commonly used ICG.

[0018] The balloon 12 is made of a highly elastic material such as silicone rubber, synthetic rubber, polyurethane elastomer, polyamide elastomer, etc. As the synthetic rubber, a styrene-butadiene polymer, polybutadiene, methyl methacrylate-butadiene polymer, acrylonitrile-butadiene polymer, etc. are used. The material of the balloon 12 does not contain a near-infrared fluorescent material, but contains a reflective substance that reflects the near-infrared fluorescence from the catheter tube 11.

[0019] Examples of reflective materials that can be used include bismuth carbonate, barium sulfate, silicon oxide, titanium oxide, bismuth oxide, zirconium oxide, bismuth nitrate, fluororesin, polytetrafluoroethylene (PTFE), etc. By mixing these reflective materials into the material of the balloon 12, the balloon 12 can reflect the fluorescence from the catheter tube 11 and become visible when the balloon catheter 10 is irradiated with excitation light, even if the balloon 12 does not contain a near-infrared fluorescent dye.

[0020] Fig. 2 is a schematic cross-sectional view of the catheter tube 11. The catheter tube 11A in Fig. 2(A) is entirely made of a resin in which a near-infrared fluorescent dye is kneaded. The catheter tube 11A has a first lumen 113 and a second lumen 114. The first lumen 113 is used to inflate or deflate the balloon 12. When the balloon catheter 10 is inserted to a fixed position in the body, a branched funnel is connected to the end of the catheter tube 11A opposite to the balloon 12, and a liquid such as sterile distilled water or a gas such as air is injected into the first lumen 113 to inflate the balloon 12.

[0021] The second lumen 114 is a lumen for sucking bodily fluids. When the balloon catheter 10 is used as a urethral catheter, the second lumen 114 is used for urine outflow. The double-lumen type catheter tube in Fig. 2 is one example, and the balloon catheter 10 may be a single-lumen type or a triple-lumen type depending on the purpose of use.

[0022] The catheter tube 11B in Fig. 2(B) has a two-layer structure of an inner layer 111 and an outer layer 112. Near-infrared fluorescent dye is mixed only in the outer layer 112. The configuration in Fig. 2(B) can reduce the amount of near-infrared fluorescent dye used and reduce manufacturing costs.

[0023] A reflective material that reflects near-infrared fluorescence may be added to the inner layer 111. This two-layer structure is also applicable to single and triple lumens.

[0024] Figure 3 is an image of the balloon catheter 10 observed with a near-infrared camera. The outer diameter of the catheter tube 11 of this balloon catheter 10 is 10 mm, the balloon 12 is made of silicone, and bismuth carbonate is added as a reflective material. The concentration of bismuth carbonate added is about 25% by weight. The image was obtained by irradiating the balloon catheter 10 with near-infrared light generally used for ICG and capturing the fluorescence from the balloon catheter 10 with a near-infrared camera for ICG.

[0025] Although the near-infrared fluorescent dye is mixed only in the catheter tube 11, the shape of the balloon 12 is clearly captured. This is because the near-infrared camera detects the near-infrared fluorescence from the catheter tube 11 as well as the light reflected by the balloon 12.

[0026] FIG. 4 is a near-infrared image showing a first comparative example. In the first comparative example, a near-infrared fluorescent dye is mixed into the catheter tube 11, but neither the near-infrared fluorescent dye nor a reflective material is mixed into the balloon. The catheter tube 11 is a polyurethane tube containing a near-infrared fluorescent dye, as in FIG. 3. When this balloon catheter is irradiated with near-infrared light, only the near-infrared fluorescence from the catheter tube 11 is observed. In reality, a balloon is inflated around the catheter tube 11, but since the balloon contains neither a near-infrared fluorescent dye nor a reflective material, the balloon cannot be visualized even when irradiated with near-infrared light for excitation.

[0027] Figure 5 is a near-infrared image showing a second comparative example. In the second comparative example, the balloon 12 is made of silicone mixed with bismuth carbonate, and the catheter tube 11 is made of polyurethane resin kneaded with a near-infrared fluorescent dye. However, the surface of the catheter tube 11 located inside the balloon 12 is covered with a shielding film. The shielding film is an absorptive film that absorbs light of near-infrared wavelengths.

[0028] When the entire balloon catheter is irradiated with near-infrared excitation light, near-infrared fluorescence is generated from the catheter tube 11 in the portion not covered with the shielding film, and can be observed with a near-infrared camera, but an image of the portion covered with the shielding film cannot be obtained. A reflective substance that reflects the near-infrared fluorescence from the catheter tube 11 is mixed into the balloon 12, but the catheter tube 11 in the portion facing the balloon 12 is covered with a shielding film, so no fluorescence is obtained. Since there is no fluorescence from the catheter tube 11 in the portion facing the balloon 12, the balloon cannot be visualized even if a balloon 12 containing a reflective substance is used.

[0029] FIG. 6 is an image of another balloon catheter 10 captured by a near-infrared camera. The catheter tube 11 of this balloon catheter 10 has an outer diameter of 10 mm, and the balloon 12 is made of polyurethane elastomer, to which barium sulfate is added as a reflective material. The concentration of barium sulfate added is 20% by weight. The balloon catheter 10 is irradiated with near-infrared light commonly used for ICG, and the fluorescence from the balloon catheter 10 is captured by a near-infrared camera for ICG. Although only the catheter tube 11 is kneaded with a near-infrared fluorescent dye, the shape of the balloon 12 is clearly captured. This is because the infrared camera detects the near-infrared fluorescence from the catheter tube 11 as well as the light reflected by the balloon 12.

[0030] The observation results of Figures 3 to 6 show that the entire balloon catheter 10 can be visualized by mixing a reflective material that reflects the fluorescence from the catheter tube 11 into the balloon 12, without mixing a near-infrared fluorescent dye into the balloon 12.

[0031] 7 is a schematic diagram showing an example of use of the balloon catheter 10 of the first embodiment. The balloon catheter 10 is inserted into the bladder 42 from the urethra 45 without inflating the balloon 12. Once the balloon catheter 10 has been inserted to a fixed position, the balloon 12 is inflated. By inflating the balloon 12, the balloon catheter 10 is retained at the entrance to the bladder 42.

[0032] By irradiating the balloon catheter 10 with near-infrared light, fluorescence can be obtained from both the catheter tube 11 and the balloon 12. As described above, the fluorescence from the balloon 12 is reflected fluorescence that reflects the fluorescence from the catheter tube 11. By observing the fluorescence from the catheter tube 11 and the balloon 12, the position of the urethra 45, the boundary between the urethra 45 and the bladder 42, the boundary between the urethra 45 and the prostate 43, etc. can be identified.

[0033] The balloon catheter 10 can be applied not only to a urethral catheter but also to a ureteral catheter. In this case, the diameter of the catheter tube 11 is smaller than that of a urethral catheter, but a near-infrared fluorescent dye can be mixed into the catheter tube 11. By adding a reflective material that reflects the fluorescence from the catheter tube 11 to the balloon 12, both the catheter tube 11 and the balloon 12 can be visualized. Since the position of the ureter and the boundary between the ureter and the kidney can be visualized, damage to the ureter and kidney during surgery can be suppressed.

[0034] The balloon catheter 10 may be applied to a catheter for a blood vessel. When the balloon 12 is used to widen a blood vessel or to assist in hemostasis, the balloon 12 reflects the fluorescence from the catheter tube 11, allowing a target internal body site to be clearly monitored.

[0035] <Second embodiment> 8 is a schematic diagram of a catheter tube set 20 which is an indwelling medical device of the second embodiment. The catheter tube set 20 includes a first catheter tube 21 as a first assembly and a second catheter tube 22 as a second assembly. The second catheter tube 22 is provided in parallel with the first catheter tube 21.

[0036] Depending on the purpose and location of the catheter tube, it may be necessary to use two tubes in parallel for observation with a near-infrared camera instead of just one. By mixing the near-infrared fluorescent dye into only one of the catheter tubes instead of mixing the near-infrared fluorescent dye into both catheter tubes, the amount of near-infrared fluorescent dye used can be reduced, leading to cost savings.

[0037] For example, the first catheter tube 21 is formed from a resin into which a near-infrared fluorescent dye has been kneaded, and the second catheter tube 22 is formed from a resin to which no near-infrared fluorescent dye has been added. A substance that reflects the near-infrared fluorescence from the first catheter tube 21 is added to the second catheter tube 22. The resin materials that form the bases of the first catheter tube 21 and the second catheter tube 22 may be the same or different.

[0038] The first catheter tube 21 is made of polyurethane resin, polyamide resin, polyethylene resin, fluororesin, polypropylene resin, polycarbonate resin, polymethylmethacrylate (PMMA), polyethylene terephthalate (PET), polystyrene (PS), or the like.

[0039] As the near-infrared fluorescent dye that can be kneaded with the resin, a known near-infrared fluorescent material is used. As in the first embodiment, dyes such as polymethylene, phthalocyanine, naphthoquinone, anthraquinone, dithiol metal complex salt, azo, and triarylmethane can be used. As described above, it is desirable to select a combination that can obtain high-intensity near-infrared fluorescence by appropriately combining the resin material and the near-infrared fluorescent dye.

[0040] The first catheter tube 21 may be entirely made of resin mixed with a near-infrared fluorescent dye, or may have a two-layer structure of an outer layer and an inner layer, with the near-infrared fluorescent dye only being contained in the outer layer, as shown in Fig. 2(B). A reflective material that reflects near-infrared fluorescence may be added to the inner layer.

[0041] The second catheter tube 22 may be made of the same material as that used for the first catheter tube 21, or may be made of silicone rubber, synthetic rubber, polyurethane elastomer, polyamide elastomer, etc. The second catheter tube 22 does not contain a near-infrared fluorescent material, but has a reflective substance that reflects near-infrared fluorescence mixed therein.

[0042] The reflective material, like in the first embodiment, is bismuth carbonate, barium sulfate, silicon oxide, titanium oxide, bismuth oxide, zirconium oxide, bismuth nitrate, fluororesin, polytetrafluoroethylene (PTFE), etc. By arranging the second catheter tube 22 in parallel within the reach of the fluorescence from the first catheter tube 21, it is possible to obtain reflected fluorescence from the second catheter tube 22.

[0043] The lumen types of the first catheter tube 21 and the second catheter tube may be the same or different. Depending on the purpose of using the catheter tube set 20, the substances to be flowed in and out of the lumens, etc., a combination of a single lumen catheter tube and a double lumen catheter tube, a combination of a single lumen catheter tube and a triple lumen catheter tube, etc., can be appropriately selected.

[0044] 9 is a diagram showing the setup for experiment 1 for investigating reflection of near-infrared fluorescence in the second embodiment. In experiment 1, a second catheter tube 22A containing no near-infrared fluorescent dye but a substance that reflects near-infrared fluorescence is placed in parallel to a first catheter tube 21 containing a near-infrared fluorescent dye. For comparison, a catheter tube 24 containing neither near-infrared fluorescent dye nor a reflective substance is placed in parallel to the first catheter tube. Near-infrared light is irradiated from above the three catheter tubes by a near-infrared light source 26, and the fluorescence and reflection are observed.

[0045] FIG. 10 shows the specifications of the catheter tube set used in Experiment 1. The first catheter tube 21 is made of polyurethane resin containing a near-infrared fluorescent dye (indicated as "with fluorescent agent" in the figure). The lumen of the first catheter tube 21 may include a portion to which 20% by weight of barium sulfate has been added. The second catheter tube 22A is made of polyurethane resin not containing a near-infrared fluorescent dye (indicated as "without fluorescent agent" in the figure). The second catheter tube 22A contains 40% by weight of barium sulfate as a reflective material.

[0046] The catheter tube 24 of the comparative example is made of a transparent polyurethane resin and does not contain any near-infrared fluorescent dye or reflective material. Titanium oxide in the figure is one of the reflective materials that reflects near-infrared fluorescence, but titanium oxide was not used in Experiment 1.

[0047] Figure 11A is an image when the near-infrared light was turned off in experiment 1. The image in Figure 11A was taken with a normal visible light camera, and an image of the transparent catheter tube 24 placed on a stage with grid lines was also acquired. Because the near-infrared light source is turned off, the near-infrared fluorescent material contained in the first catheter tube 21 is not excited and does not emit fluorescence. Because the first catheter tube 21 does not emit fluorescence, there is no reflection by the second catheter tube 22A.

[0048] FIG. 11B is an image taken when the near-infrared light was turned on in experiment 1. The image in FIG. 11B was taken with a general near-infrared camera for ICG. The near-infrared fluorescent material contained in the first catheter tube 21 is excited and emits bright fluorescence. The second catheter tube 22A does not contain a near-infrared fluorescent material, but contains a reflective substance that reflects near-infrared fluorescence, so that reflected light from the second catheter tube 22A can be observed. This reflected light makes it possible to know the presence and position of the second catheter tube 22A.

[0049] In the catheter tube 24 of the comparative example, even when the near-infrared light is turned on, no fluorescence or reflection occurs, and nothing is detected as a near-infrared image. From experiment 1, it is confirmed that even if the second catheter tube 22A does not contain a near-infrared fluorescent dye, by containing a substance that reflects near-infrared fluorescence, it can be visualized using the fluorescence from the first catheter tube 21. The effect of adding a reflective substance is also confirmed by the fact that the presence of the catheter tube 24 of the comparative example that does not contain a reflective substance is not detected.

[0050] Fig. 12 shows the specifications of the catheter tube set used in Experiment 2 of the second embodiment. In Experiment 2, the first catheter tube 21 is made of polyurethane resin containing a near-infrared fluorescent dye, as in Experiment 1. The first catheter tube 21 may be partially made of resin containing 20% ​​by weight of barium sulfate. The second catheter tube 22B is made of polyolefin not containing a near-infrared fluorescent material. The second catheter tube 22B contains titanium oxide as a reflective material.

[0051] FIG. 13A is an image when the near-infrared light is turned off in experiment 2, and FIG. 13B is an image when the near-infrared light is turned on. The image in FIG. 13A was taken with a normal visible light camera, and the image shows the appearance of the first catheter tube 21 and the second catheter tube 22B arranged on a stage with grid lines. In FIG. 13B, when the near-infrared light is turned on, the first catheter tube 21 emits fluorescence. Although the second catheter tube 22B does not contain a near-infrared fluorescent material, its presence and position are detected by reflecting the fluorescence from the first catheter tube 21. Experiment 2 also confirms the effect of adding a substance that reflects near-infrared fluorescence to the second assembly.

[0052] The number of catheter tubes used simultaneously is not limited to two. The catheter tube set 20 may include three catheter tubes used in parallel close to each other. In this case, too, all of the catheter tubes can be visualized by kneading a near-infrared fluorescent dye into only one of the catheter tubes and mixing a reflective material that reflects near-infrared fluorescence into the other two catheter tubes.

[0053] With the configuration of the second embodiment, by mixing a near-infrared fluorescent dye into one catheter tube, the presence and position of other catheter tubes can be visualized. This allows for observation and surgery that reduces costs and minimizes damage to internal organs.

[0054] <Third embodiment> 14 is a schematic diagram of an endoscopic clip set 30 which is an indwelling medical device of a third embodiment. The endoscopic clip set 30 includes a first clip 31 as a first assembly and a second clip 32 as a second assembly. The first clip 31 is formed of a resin kneaded with a near-infrared fluorescent dye. The second clip 32 is formed of a resin to which no near-infrared fluorescent dye has been added but to which a reflective material that reflects near-infrared fluorescence from the first clip 31 has been added. The resin materials that serve as the bases of the first clip 31 and the second clip 32 may be the same or different.

[0055] The first clip 31 and the second clip are desirably formed of a resin having both elasticity and rigidity in order to grasp internal tissue at a target location for hemostasis, suturing, etc. The first clip 31 and the second clip are formed of polyether ether ketone (PEEK), polypropylene resin, polycarbonate resin, polymethyl methacrylate (PMMA), polyethylene terephthalate (PET), polystyrene (PS), or the like.

[0056] The near-infrared fluorescent dye kneaded into the first clip 31 is, as in the first and second embodiments, a dye such as a polymethylene-based, phthalocyanine-based, naphthoquinone-based, anthraquinone-based, dithiol metal complex salt, azo-based, or triarylmethane-based dye. It is desirable to appropriately select a combination of the resin and the near-infrared fluorescent dye to be used so as to have the desired fluorescent properties.

[0057] The first clip 31 may be entirely made of a resin containing a near-infrared fluorescent dye, or may be partially made of a resin containing a near-infrared fluorescent dye and the remainder made of a metal such as stainless steel. The second clip 32 may be made of the same material as the first clip 31, or may be made of a different material. The second clip 32 does not contain a near-infrared fluorescent material, but has a reflective material that reflects near-infrared fluorescence mixed in.

[0058] The reflective material, like the first embodiment, is bismuth carbonate, barium sulfate, silicon oxide, titanium oxide, bismuth oxide, zirconium oxide, bismuth nitrate, fluororesin, polytetrafluoroethylene (PTFE), etc. By disposing the second clip within the range reached by the fluorescence from the first clip 31, it is possible to obtain reflected fluorescence from the second clip 32.

[0059] Fig. 15 is a schematic diagram showing an example of use of the endoscopic clip set 30 of Fig. 14. The first clip 31 and the second clip 32 are fixed to an internal organ, for example, the mucous membrane 41 of a blood vessel, by a dedicated clip applicator (not shown). When near-infrared light is irradiated from outside the blood vessel, the near-infrared fluorescent dye contained in the first clip 31 is excited and emits fluorescence. The second clip 32 reflects the fluorescence of the first clip. As a result, both the first clip 31 and the second clip 32 are imaged by the near-infrared camera.

[0060] The number of clips included in the endoscopic clip set 30 is not limited to two. When two or more clips are used adjacent to each other at the same internal site, a near-infrared fluorescent dye may be mixed into only one of the clips, and a reflective material that reflects near-infrared fluorescence may be mixed into the other clips.

[0061] The configuration of the third embodiment allows one clip to be mixed with a near-infrared fluorescent dye and the fluorescent reflection from another clip to be observed. This allows for cost reduction and enables observation and surgery that minimizes damage to internal organs.

[0062] <Endoscope system> 16 is a schematic diagram of an endoscope system 100 using an indwelling medical device. The endoscope system 100 includes an indwelling medical device (for example, a balloon catheter 10), a near-infrared camera 50, an imaging processor 60, and a monitor display 70. In this example, the balloon catheter 10 of the first embodiment is used, but the catheter tube set 20 of the second embodiment or the endoscope clip set 30 of the third embodiment may also be used.

[0063] The near-infrared camera 50 is inserted from a body cavity (peritoneal cavity in this example) to the vicinity of the internal part to be monitored. The near-infrared camera 50 has an image sensor 501 having sensitivity to near-infrared wavelengths. An objective lens may be provided on the light receiving surface side of the image sensor. The near-infrared camera 50 may incorporate a near-infrared light source such as an LED as an excitation light source, or may be configured to irradiate excitation light from an external excitation light source 502 using a light guide such as an optical fiber. A general near-infrared camera for ICG may be used as the near-infrared camera 50.

[0064] When an indwelling medical device (for example, the balloon catheter 10) is irradiated with near-infrared light from the excitation light source 502, fluorescence having a slightly longer wavelength than the excitation light is obtained from the catheter tube 11 and the balloon 12. Of these, the fluorescence obtained from the balloon 12 is reflected fluorescence obtained by reflecting the fluorescence from the catheter tube 11 by the balloon 12.

[0065] The near-infrared camera 50 captures near-infrared fluorescence and its reflection to obtain image information of the balloon catheter 10 in pixel units. A cut filter for near-infrared light for excitation may be provided on the light receiving surface of the image sensor of the near-infrared camera 50. This allows only the fluorescence and reflected light from the balloon catheter 10 to be captured.

[0066] The imaging processor 60 performs correction processing, image processing, format conversion, etc. on the image information (e.g., digital electrical signals) output from the near-infrared camera 50 to generate image data that can be displayed on the monitor display 70. The monitor display 70 displays the generated image data, thereby displaying an image of the balloon catheter 10 placed inside the body.

[0067] Although the present disclosure has been described above based on specific examples, the present disclosure is not limited to the above examples. Even when the catheter tube 11 and the balloon 12 of the balloon catheter 10 are formed of the same resin material, the balloon 12 may be configured to be added with a reflective material instead of adding a near-infrared fluorescent dye. This allows the amount of near-infrared fluorescent material used to be reduced. The amount of the reflective material added may be adjusted according to the intensity of the reflected fluorescence. In either case, the presence and position of the assembly not containing the near-infrared fluorescent material can be detected by using a general near-infrared camera for ICG as it is. [Explanation of symbols]

[0068] 10 Balloon catheter (medical device placed inside the body) 11 Catheter tube (first assembly) 111 Inner Layer 112 Outer Layer 12 Balloon (2nd assembly) 20 Catheter tube set (medical device placed in the body) 21 First catheter tube (first assembly) 22, 22A, 22B Second catheter tube (second assembly) 26 Near-infrared light source 30 Endoscopic clip set (medical device placed in the body) 31 First clip (first assembly) 32 Second clip (second assembly) 50 Near-infrared camera 100 Endoscope system 501 Image Sensor 502 Excitation light source

Claims

1. a first assembly formed of a first material including a fluorescent dye that emits near-infrared light; a second assembly formed of a second material that reflects near-infrared light and that reflects the near-infrared light emitted from the first assembly; An indwelling medical device having The second assembly is disposed outside the first assembly within a range of the near-infrared light emitted from the first assembly, forming an indwelling medical device.

2. the first assembly is formed of a resin containing the fluorescent dye, and the second assembly does not contain the fluorescent dye; The indwelling medical device according to claim 1.

3. The first assembly is a catheter tube, and the second assembly is a balloon provided on the outer periphery of the catheter tube. The medical device according to claim 1 or 2.

4. The first assembly is a first catheter tube, and the second assembly is a second catheter tube arranged in parallel with the first catheter tube. The medical device according to claim 1 or 2.

5. the indwelling medical device is an endoscopic clip set, the first assembly is one clip in the endoscopic clip set, and the second assembly is another clip in the endoscopic clip set; The medical device according to claim 1 or 2.

6. The medical device of any one of claims 1 to 5, wherein the second assembly includes bismuth carbonate, barium sulfate, silicon oxide, titanium oxide, bismuth oxide, zirconium oxide, bismuth nitrate, fluororesin, or polytetrafluoroethylene in the second material.

7. The indwelling medical device according to any one of claims 1 to 6, an excitation light source that excites the fluorescent dye; an image sensor that detects the near-infrared light emitted from the first assembly and the near-infrared light reflected by the second assembly to obtain an image of the indwelling medical device; An endoscope system comprising:

8. a monitor display that displays the image acquired by the image sensor; The endoscope system according to claim 7 , further comprising:

Images