Medical devices and medical systems

The medical device addresses the challenge of detecting fluorescence with high sensitivity by using a shaft with emission and light-receiving parts separated by a light-shielding part, enabling efficient excitation light emission and fluorescence reception in a narrow biological environment.

JP7887304B2Active Publication Date: 2026-07-09TERUMO KK

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
TERUMO KK
Filing Date
2022-07-28
Publication Date
2026-07-09

AI Technical Summary

Technical Problem

Existing medical devices struggle to detect fluorescence with high sensitivity when emitting excitation light and receiving fluorescence in a narrow biological environment due to the direct entry of excitation light into the light-receiving unit, reducing detection efficiency.

Method used

A medical device with a long shaft containing an emission part, a light-receiving part, and a light-shielding part positioned to prevent direct entry of excitation light into the light-receiving part, allowing both excitation light emission and fluorescence reception in a narrow space with high sensitivity.

Benefits of technology

The device achieves simultaneous emission of excitation light and reception of fluorescence with high sensitivity by positioning the emission and light-receiving parts close together on the same shaft, effectively detecting fluorescence while minimizing invasiveness.

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Abstract

To provide a medical device, a medical system, and a diagnosis and treatment method capable of detecting fluorescent light with high sensitivity while executing both emission of excitation light and reception of fluorescent light in a narrow living body.SOLUTION: A medical device 10 for radiating excitation light in a living body and detecting fluorescent light emitted by a photosensitive substance excited by the excitation light includes a long-sized shaft 11 with an axial center X extending from the base end to the tip. The shaft 11 includes an emission part 32 for emitting the excitation light, a light reception part 42 for receiving the fluorescent light, in which the tip of the emission part 32 and the tip of the light reception part 42 are disposed at different positions in an axial direction of the shaft, and a light blocking part 50 disposed at a position crossing a straight line L extending on the tip side along the axial center X from what is disposed on the base end side of the emission part 32 and the light reception part 42, and between the emission part 32 and the light reception part 42.SELECTED DRAWING: Figure 2
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Description

Technical Field

[0001] The present invention relates to a medical device and medical system Mu .

Background Art

[0002] As local treatments for cancer, photodynamic therapy and photoimmunotherapy using photoreactive substances having tumor cell selectivity are known. Among them, a treatment method using a photosensitive substance (hydrophilic phthalocyanine) can specifically destroy target cells without destroying non-target cells such as normal cells by irradiating the photosensitive substance accumulated in the tumor with excitation light (for example, near-infrared light), and is expected to obtain a high treatment effect while reducing side effects.

[0003] By the way, Patent Document 1 describes an imaging device that irradiates a fluorescent agent in a subject with excitation light from a light source disposed outside the subject's body and detects fluorescence emitted by the fluorescent agent by a detection unit disposed away from the light source outside the subject's body.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] When emitting excitation light from outside the subject's body and receiving fluorescence outside the body, only the most superficial part of the subcutaneous tumor can be imaged. However, in order to insert the emission unit and the light receiving unit that emit excitation light into a narrow region in the living body, the emission unit and the light receiving unit need to be close to each other, and the excitation light emitted from the emission unit is likely to directly enter the light receiving unit, and the detection sensitivity of fluorescence is likely to decrease.

[0006] This invention was made to solve the above-mentioned problems, and is a medical device that can detect fluorescence with high sensitivity while simultaneously achieving emission of excitation light and reception of fluorescence in a narrow biological environment. and Medical system Mu The purpose is to provide. [Means for solving the problem]

[0007] A medical device according to the present invention that achieves the above objective is a medical device that irradiates excitation light into a living body and detects fluorescence emitted by a photosensitive substance excited by the excitation light, and has a long shaft with an axis extending from the base end to the tip, wherein the shaft has an emission part that emits the excitation light, a light-receiving part that receives the fluorescence, wherein the tip of the emission part and the tip of the light-receiving part are arranged at different positions in the axial direction of the shaft, and a light-shielding part that is positioned to cross a straight line extending from the base end side of the emission part and the light-receiving part along the axis toward the tip side, and is arranged between the emission part and the light-receiving part. [Effects of the Invention]

[0008] As described above, the medical device can prevent the excitation light emitted from the emission unit from directly entering the light-receiving unit by the light-shielding section, allowing the emission unit and light-receiving unit to be placed close together on the same shaft. Therefore, this medical device, medical system, and treatment method, by inserting the shaft equipped with the emission unit and light-receiving unit into the body, can achieve both the emission of excitation light and the reception of fluorescence in the narrow space of the body, while the light-shielding section placed on the shaft allows for the detection of fluorescence with high sensitivity.

[0009] The light-receiving section may be positioned closer to the tip of the light-emitting section than the tip of the light-emitting section. This allows the medical device to effectively position the light-receiving section to a location where it can receive fluorescence.

[0010] The light-emitting surface of the light-emitting section may have a normal component directed in a lateral direction perpendicular to the axis of the shaft, or it may be formed as a light-scattering material. This allows the medical device to irradiate a wide area with excitation light emitted from the light-emitting surface.

[0011] The light-shielding portion may have an absorbent portion that absorbs light facing the tip and a reflective portion that reflects light facing the base. This allows the medical device to efficiently irradiate a wide area with excitation light by reflecting the excitation light emitted from the emitter portion with the reflective portion facing the side where the emitter portion is located. Furthermore, the medical device suppresses the incidence of excitation light into the light-receiving portion by absorbing the excitation light reflected by tissue or a part of the medical device with the absorbent portion facing the side where the light-receiving portion is located, allowing the light-receiving portion to detect fluorescence with high sensitivity.

[0012] The light-shielding portion has an outer edge having a normal component that is oriented in a lateral direction perpendicular to the axis of the shaft, and the outer edge may be a light-absorbing portion and / or a light-reflecting portion. As a result, the medical device can efficiently irradiate a wide area with excitation light by reflecting the excitation light with the light-reflecting portion of the outer edge. Furthermore, the medical device can suppress the incidence of excitation light into the light-receiving portion by absorbing the excitation light with the light-absorbing portion of the outer edge, allowing the light-receiving portion to detect fluorescence with high sensitivity.

[0013] The area of ​​the light-receiving surface of the light-receiving unit may be larger than the area of ​​the light-emitting surface of the light-emitting unit. This allows the medical device to effectively receive fluorescence, which has lower energy than the excitation light, using a light-receiving surface with a larger area than the light-emitting surface.

[0014] The shaft has an outer casing that is light-transmitting and covers the light-emitting portion and the light-receiving portion. The light-shielding portion has a light-absorbing portion that absorbs light,The light-absorbing portion may be capable of absorbing at least one of the excitation light directly emitted from the emission portion, the excitation light reflected by the outer casing, or the excitation light reflected within the living body. As a result, the medical device can suppress the incidence of excitation light to the light-receiving portion by absorbing a portion of the excitation light with the light-absorbing portion, and the light-receiving portion can detect fluorescence with high sensitivity.

[0015] The outer casing may have a puncture function at its tip. This allows the medical device to puncture tissue using the outer casing without using a separate component with a puncture function.

[0016] The medical device may have a puncture section that is separate from the outer casing. This allows the puncture section to be operated independently of the outer casing, thereby improving operability during tissue puncture.

[0017] The light-shielding portion may have an absorbent portion that absorbs the excitation light emitted from the emission portion and suppresses the direct incidence of the excitation light to the light-receiving portion. As a result, the medical device can suppress the direct incidence of excitation light to the light-receiving portion by the absorbent portion, and the light-receiving portion can detect fluorescence with high sensitivity.

[0018] The light-shielding portion may have a reflective portion that reflects the excitation light emitted from the emission portion, thereby suppressing the direct incidence of the excitation light to the light-receiving portion. As a result, the medical device can suppress the direct incidence of the excitation light to the light-receiving portion by the reflective portion, allowing the light-receiving portion to detect fluorescence with high sensitivity.

[0019] The medical system according to the present invention for achieving the above object is a medical system that irradiates excitation light into a living body and detects fluorescence emitted by a photosensitive substance excited by the excitation light, and includes a medical device having a shaft that is long along an axis extending from a proximal end to a distal end, and a light source connected to the medical device. The shaft has an emitting portion that emits the excitation light and a light receiving portion that receives the fluorescence. The light receiving portion is arranged at a position different from that of the distal end of the emitting portion in the axial direction of the shaft. The light receiving portion and a light shielding portion are arranged at a position that crosses a straight line extending from the proximal end side to the distal end side along the axis among the emitting portion and the light receiving portion and is arranged between the emitting portion and the light receiving portion.

[0020] The medical system configured as described above can suppress the excitation light emitted from the emitting portion from directly entering the light receiving portion by the light shielding portion. Therefore, the emitting portion and the light receiving portion can be arranged close to each other on the same shaft. For this reason, the present medical system can achieve both the emission of excitation light and the reception of fluorescence in a narrow living body by inserting a shaft provided with the emitting portion and the light receiving portion into the living body, and can detect fluorescence with high sensitivity by the light shielding portion arranged on the shaft.

[0021] The light receiving portion may be arranged on the distal end side of the distal end of the emitting portion. Thereby, the medical system can effectively reach the light receiving portion to a position where fluorescence can be received.

[0022] The medical system may have an optical sensor that converts the fluorescence received by the light receiving portion into an electrical signal. Thereby, since the medical system can convert the information of the fluorescence into an electrical signal, it can facilitate the transmission, reception, and arithmetic processing of the fluorescence information.

[0023] The medical system may have a display device that displays the information acquired by the optical sensor. Thereby, the medical system can display the information acquired by the optical sensor on the display device so that an operator or the like can understand it visually.

[0024] The medical system may have a puncture part with light transmissibility into which the medical device can be inserted. Thereby, the medical system can irradiate excitation light from the emission part or receive fluorescence by the light receiving part through the puncture part.

[0025] The medical system may have an exterior part with light transmissibility that covers the emission part and the light receiving part. Thereby, the medical system can irradiate excitation light from the emission part or receive fluorescence by the light receiving part through the exterior part that covers the emission part and the light receiving part. Also, the medical system can protect the emission part and the light receiving part by the exterior part.

[0026] The exterior part may have a puncture function at its tip. Thereby, the medical system can perform tissue puncture by the exterior part without using a member having a puncture function separate from the exterior part.

[0027] The medical system may have a puncture part separate from the exterior part. Thereby, since the puncture part of the medical system can be operated independently of the exterior part, the operability in tissue puncture is improved.

Brief Description of the Drawings

[0030] [Figure 1] It is a plan view showing a medical system according to an embodiment. [Figure 2] It is a plan view of the tip part of the medical system shown through the exterior part. [Figure 3] It is a plan view of the tip part of the medical system shown through the puncture part and the exterior part. [Figure 4] It is a plan view of the tip part of the first modification example of the medical system shown through the exterior part. [Figure 5] It is a plan view of the tip part of the second modification example of the medical system shown through the exterior part. [Figure 6] It is a plan view of the tip part of the third modification example of the medical system shown through the exterior part. [Figure 7]This is a plan view of the tip of the fourth modified medical system, shown through the exterior. [Figure 8] This is a plan view of the tip of the fifth modified example of the medical system, shown through the exterior. [Figure 9] This is a schematic diagram showing a medical system inserted into the cervix. [Figure 10] This is a schematic diagram showing the tip of a medical system used to explain the excitation light emitted from an outlet inserted into the cervix. [Figure 11] This is a schematic diagram showing the tip of a medical system used to explain fluorescence detected by a light-receiving element inserted into the cervix. [Modes for carrying out the invention]

[0031] Embodiments of the present invention will be described below with reference to the drawings. Note that the dimensions in the drawings may be exaggerated for illustrative purposes and may differ from the actual dimensions. In addition, in this specification and drawings, components having substantially the same functional configuration are denoted by the same reference numerals to avoid redundant explanation. In this specification, the side of the device that is inserted into a biological lumen will be referred to as the "tip side," and the side that is operated will be referred to as the "proximal side."

[0032] The medical system 1 according to this embodiment is used for the treatment of cervical tumors. This medical system 1 is used in photoimmunotherapy, which destroys target cells by irradiating a photosensitive substance accumulated in the tumor cells with near-infrared light, which is the excitation light for the photosensitive substance. Target cells are tumor cells such as cancer cells and cells of precancerous lesions. In this treatment method, an antibody that specifically binds only to a specific antigen on the surface of tumor cells and a photosensitive substance bound to that antibody are used as drugs. The antibody is not particularly limited, but examples include panitumubab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitive substance is, for example, a hydrophilic phthalocyanine (IR700) that reacts to near-infrared light with a wavelength of approximately 700 nm, but is not limited to this. When IR700 receives near-infrared light with a wavelength of approximately 660-740 nm, the ligand of the functional group that ensures water solubility is cleaved, causing a structural change from water-soluble to hydrophobic. This structural change causes membrane proteins to be extracted, creating holes in the cell membrane that allow water to enter the cell, thus rupturing and destroying tumor cells. In addition, IR700 is excited by near-infrared light and emits fluorescence at a wavelength different from the excitation wavelength. For example, when IR700 is excited by near-infrared light with a wavelength of 689 nm, it emits fluorescence at a wavelength of 704 nm. IR700 undergoes a structural change while emitting fluorescence through a photoreaction, destroying tumor cells and fulfilling its role as a drug, after which it ceases to emit fluorescence.

[0033] The medical system 1 shown in Figure 1 is inserted into the cervical canal CC of the cervix U via the vagina V, as shown in Figure 6, to treat tumors of the cervix U (e.g., cervical cancer).

[0034] As shown in Figures 1 and 2, the medical system 1 includes a medical device 10 to be inserted into the body, a light source 70 to which the medical device 10 is connected, a photodetector 80 to which the medical device 10 is connected, and a display device 90 to which the photodetector 80 is connected.

[0035] The medical device 10 has a long shaft 11 with an axis X extending from the base to the tip, and an operating part 60 connected to the base end of the shaft 11. The shaft 11 has a light irradiation part 30 for irradiating a photosensitive substance with excitation light, a fluorescence detection part 40 for receiving light to detect fluorescence emitted by the excited photosensitive substance, and a light shielding part 50 for shielding the excitation light. The shaft 11 may further have a long tubular outer casing 20.

[0036] The outer casing 20 is a tubular body extending from the operating section 60 toward the tip. The outer casing 20 houses the light irradiation section 30, the fluorescence detection section 40, and the light shielding section 50 within its lumen. Preferably, the outer casing 20 is positioned in close contact with the light shielding section 50 without any gaps. This prevents the excitation light emitted from the light irradiation section 30 from directly entering the fluorescence detection section 40. The base end of the outer casing 20 is fixed to the operating section 60. The lumen of the outer casing 20 is closed and sealed at the tip of the outer casing 20. The lumen of the outer casing 20 is open at the base end of the outer casing 20, allowing it to receive the light irradiation section 30 and the fluorescence detection section 40. The outer casing 20 is a straight-extending cylindrical tube, but it may be curved or not be cylindrical. The outer casing 20 may also house the light irradiation section 30, the fluorescence detection section 40, and the light shielding section 50 so as to be movable along the axis X of the shaft 11.

[0037] The outer casing 20 has a light-transmitting portion 21 at least at its tip that is capable of transmitting excitation light and fluorescence. The light-transmitting portion 21 is located in a predetermined range at least at the tip of the outer casing 20. At least a portion of the light-transmitting portion 21 is the portion that is inserted from the external os O to the cervical canal CC (see Figure 6). The light-transmitting portion 21 is formed of a transparent or translucent material that has light-transmitting properties that can transmit excitation light of a wavelength emitted by the light-irradiating portion 30 and fluorescence of a wavelength emitted by a photosensitive substance. The portion of the outer casing 20 closer to the proximal end than the light-transmitting portion 21 may be transparent or not. The entire outer casing 20 may be the light-transmitting portion 21.

[0038] The outer casing 20 preferably has a certain degree of rigidity so that the operator can grasp the operating part 60 and push it to the desired position. The constituent material of the light-transmitting part 21 is not particularly limited, but examples include resins such as polymethyl methacrylate, polyethylene terephthalate, polycarbonate, and polytetrafluoroethylene, as well as glass. It is more preferable that the material of the outer casing 20 has elastic properties so that it can bend and deform along the cervical canal CC after being inserted into the cervical canal CC. This allows for adaptation to individual differences in the shape of the cervical canal, reduces the burden on the inner surface of the cervical canal, and further improves adhesion to the inner surface of the cervical canal.

[0039] The portion of the outer casing 20 closer to the proximal end than the light-transmitting portion 21 may be formed from the same material as the light-transmitting portion 21, or from a different material. In this case, the portion of the outer casing 20 closer to the proximal end than the light-transmitting portion 21 may be formed from a material that does not transmit excitation light and fluorescence, such as metals represented by stainless steel, aluminum, titanium alloy, tin, magnesium alloy, etc., or resins represented by polyether ether ketone (PEEK), polyamide, acrylonitrile butadiene styrene (ABS), polycarbonate, polyacetal, polyimide, etc.

[0040] As shown in Figure 3, the shaft 11 may have a puncture portion 22 separate from the outer casing 20. The puncture portion 22 is tubular and can movably house the outer casing 20, which covers the light irradiation portion 30, the fluorescence detection portion 40, and the light shielding portion 50, along the axis X of the shaft 11. The outer casing 20 may have a sharp puncture portion 22 at its tip, as shown in the first modified example in Figure 4. The shaft 11 does not have to have an outer casing 20. If the shaft 11 does not have an outer casing 20, the tip of the fluorescence detection portion 40 may be cut at an angle to provide a puncture function.

[0041] As shown in Figure 2, the light irradiation unit 30 has a long irradiation optical waveguide 31 and an emission unit 32 positioned at the tip of the irradiation optical waveguide 31 to emit light. The light irradiation unit 30 and the fluorescence detection unit 40 are immovable within the lumen of the outer casing 20 along the axis X of the shaft 11, but may be movable. Also, as shown in the second modified example in Figure 5, the light irradiation unit 30 may have a plurality of irradiation optical waveguides 31 arranged circumferentially to surround the outer circumference of the fluorescence detection unit 40. The emission unit 32 is formed by a plurality of emission surfaces 33 formed at the tips of the plurality of irradiation optical waveguides 31. In this case, it is preferable that the light shielding unit 50 is formed in a ring shape to surround the entire outer surface of the fluorescence detection unit 40. Note that the plurality of irradiation optical waveguides 31 may be arranged circumferentially to surround only a part of the outer circumference of the fluorescence detection unit 40 (a range of less than 360 degrees). In this case, the light-shielding portion 50 may be formed to surround a range of less than 360 degrees of the outer surface of the fluorescence detection portion 40.

[0042] The irradiation optical waveguide 31 is a long member that propagates light. The irradiation optical waveguide 31 is formed, for example, by a single optical fiber. If a hard material such as quartz glass is selected as the material of the optical fiber, the fluorescence detection unit 40 can have a puncture function. The irradiation optical waveguide 31 may be formed by multiple optical fibers. The base end of the irradiation optical waveguide 31 can be connected to a light source 70 that outputs light, as shown in Figure 1. The irradiation optical waveguide 31 can receive near-infrared light from the light source 70 and propagate the near-infrared light to the emission unit 32. The light irradiation unit 30 may be formed by an optical waveguide other than an optical fiber.

[0043] As shown in Figure 2, the emission unit 32 has an emission surface 33 that emits light. The emission surface 33 is, for example, the cut end of the optical fiber that constitutes the irradiation optical waveguide 31. In order to secure a large area, the emission surface 33 is preferably a plane having a normal component that points in the lateral direction Y perpendicular to the axis X of the shaft 11 (a plane inclined at an angle of less than 90 degrees with respect to a plane perpendicular to the axis X). This allows the emission surface 33 to have a larger area than if it were a plane perpendicular to the axial direction X, and the excitation light can be emitted effectively. The emission surface 33 may also be perpendicular to the axis X. The lateral direction Y in which the normal component of the emission surface 33 points and the lateral direction Y in which the normal component of the light-receiving surface 43 of the light-receiving unit 42, which will be described later, point are approximately opposite directions, and it is preferable that there is an angular difference of 30 to 60 degrees around the axis X. This prevents the excitation light emitted from the emission surface 33 from directly entering the light-receiving surface 43. Furthermore, it is more preferable that the emission surface 33 and the light receiving surface 43 are planes inclined at an angle of less than 90 degrees with respect to a plane perpendicular to the axis X. Alternatively, as shown in the third modified example in Figure 6, the emission section 32 is a scatterer connected to the cut end of the optical fiber constituting the illumination optical waveguide 31, and the emission surface 33 may be formed as a scatterer. The shape of the scatterer is not particularly limited, but for example, it may be hemispherical. The emission section 32 may also include a mirror and / or lens positioned at the cut end of the optical fiber. The emission section 32 is capable of emitting light propagating from the illumination optical waveguide 31 over a wide area. The emission section 32 is capable of irradiating light propagating from the illumination optical waveguide 31 in a lateral direction Y perpendicular to the axial direction X of the outer casing 20 (or the axial direction X of the illumination optical waveguide 31). The light irradiation section 30 may be capable of irradiating in directions other than the lateral direction Y. The light-emitting section 32 may be an LED or the like that emits light when powered.

[0044] As shown in Figure 2, the fluorescence detection unit 40 has a long detection optical waveguide 41 and a light receiving unit 42 located at the tip of the detection optical waveguide 41.

[0045] The detection optical waveguide 41 is a long member that propagates light. The detection optical waveguide 41 is formed by, for example, a single optical fiber. However, the detection optical waveguide 41 may be formed by multiple optical fibers. The detection optical waveguide 41 is arranged adjacent to the illumination optical waveguide 31 so as to be substantially parallel to it. The tip of the detection optical waveguide 41 is connected to the light receiving unit 42, and the base end of the detection optical waveguide 41 can be connected to an optical detection device 80 that receives light, converts it into an electrical signal, and performs calculations to output the information to the display device 90.

[0046] The light-receiving unit 42 is a component capable of propagating the received fluorescence to the detection optical waveguide 41. The light-receiving unit 42 has a light-receiving surface 43 that receives light. The light-receiving surface 43 is, for example, the tip end of the optical fiber that constitutes the detection optical waveguide 41. In order to secure a large area, the light-receiving surface 43 is a plane having a normal component directed in the lateral direction Y perpendicular to the axis X of the shaft 11 (a plane inclined at an angle of less than 90 degrees with respect to a plane perpendicular to the axis X). As a result, the light-receiving surface 43 can have a larger area than if it were a plane perpendicular to the axial direction X, and can effectively receive fluorescence. The light-receiving surface 43 may also be perpendicular to the axis X. Alternatively, the light-receiving unit 42 may be a scatterer connected to the tip end of the detection optical waveguide 41. The shape of the scatterer is, for example, hemispherical, but the shape is not limited. The scatterer that receives fluorescence can propagate the fluorescence to the tip end of the detection optical waveguide 41. Furthermore, the light-receiving unit 42 may include a mirror and / or lens in its configuration. The light-receiving unit 42 may also be a sensor that converts light into an electrical signal. In this case, the fluorescence detection unit 40 has a conductor capable of transmitting an electronic signal on the base end side of the light-receiving unit 42.

[0047] The area of ​​the light-receiving surface 43 is preferably larger than the area of ​​the emission surface 33. This is because the energy of the fluorescence emitted by the excited substance is lower than the energy of the excitation light emitted from the emission section 32, and therefore it is preferable to effectively receive the fluorescence. However, the area of ​​the light-receiving surface 43 may be less than or equal to the area of ​​the emission surface 33. The light-receiving section 42 (light-receiving surface 43) is positioned closer to the tip than the emission section 32 (emission surface 33). This is because, in order to effectively receive fluorescence with lower energy than the excitation light emitted from the emission section 32, it is preferable to bring the light-receiving section 42 closer to the tumor cells C that emit fluorescence when irradiated with excitation light.

[0048] The light-shielding portion 50 is a member that prevents excitation light emitted from the emission portion 32 from directly entering the light-receiving portion 42, and also suppresses excitation light emitted from the emission portion 32 and reflected by the outer casing 20 or biological tissue from entering the light-receiving portion 42. The light-shielding portion 50 is positioned on the tip side of the emission portion 32 and on the base end side of the light-receiving portion 42. That is, the light-shielding portion 50 is positioned between the emission portion 32 and the light-receiving portion 42 in the axial direction of the shaft 11. Furthermore, the light-shielding portion 50 is positioned to intersect a straight line L that extends from the emission portion 32 towards the tip side along the axis X. The light-shielding portion 50 may or may not intersect the straight line L perpendicularly. That is, the light-shielding portion 50 may be parallel to a plane perpendicular to the axis X, or it may be inclined. It is desirable that the light-shielding portion 50 has a light-absorbing portion 51 that absorbs light. The light-shielding portion 50 does not need to have the function of absorbing light, as long as it can block light. The light-absorbing portion 51 is formed from, for example, graphite, triiron tetroxide, or a copper-chromium-zinc composite oxide. The light-absorbing portion 51 may be a component formed entirely from the same material, or it may be formed only on the surface of the component by coating.

[0049] The light-shielding portion 50 may include a light-absorbing portion 51 and a light-reflecting portion 52, as shown in the fourth modified example in Figure 7. The light-reflecting portion 52 is located on the side closer to the light-emitting portion 32 (base end side), and the light-absorbing portion 51 is located on the side closer to the light-receiving portion 42 (tip end side). That is, the light-reflecting portion 52 is located on the base end side of the light-receiving portion 42. The light-reflecting portion 52 is formed by, for example, a mirror or a reflective coating. The light-reflecting portion 52 is formed by a material capable of reflecting light, such as titanium oxide, barium sulfate, zinc oxide, silver, or aluminum. The light-reflecting portion 52 may be a member formed entirely from the same material, or it may be formed only on the surface of the member by a coating. The light-shielding portion 50 has an outer edge portion 53 having a normal component directed in the lateral direction Y perpendicular to the axis X of the shaft 11, and the outer edge portion 53 may be a light-absorbing portion 51 and / or a light-reflecting portion 52.

[0050] As shown in Figures 2-7, the light-shielding portion 50 is arranged to surround the entire circumference of the outer surface of the fluorescence detection portion 40. That is, the light-shielding portion 50 covers the entire tip side of the emission portion 32 (emission surface 33) at a position away from the emission portion 32. However, the light-shielding portion 50 may be positioned adjacent only to a part of the outer circumference of the fluorescence detection portion 40, as long as it is positioned to cross a straight line L extending from the emission portion 32 toward the tip side along the axis X.

[0051] Furthermore, as shown in the fifth modified example in Figure 8, the light-receiving section 42 may be positioned closer to the base end than the light-emitting section 32. The light-shielding section 50 is positioned between the light-emitting section 32 and the light-receiving section 42 in the axial direction of the shaft 11. In addition, the light-shielding section 50 is positioned to cross a straight line L extending from the light-receiving section 42 toward the tip side along the axis X.

[0052] As shown in Figure 1, the operating section 60 is the part that the operator grasps and operates. The base end of the outer casing 20 is fixed to the operating section 60. A detection optical waveguide 41 and an irradiation optical waveguide 31 are led out from the operating section 60. The configuration of the operating section 60 is not particularly limited.

[0053] The light source 70 can output light of any wavelength at any intensity (power) and energy to the irradiation optical waveguide 31 of the light irradiation unit 30. For example, the light source 70 emits excitation light, which is near-infrared light with a wavelength of 660 to 740 nm, at an intensity (power) of, for example, 1 mW to 5 W, and at an intensity of, for example, 1 to 50 Jcm². -2 The output is sent to the irradiation optical waveguide 31 so that light can be irradiated with the required energy. The excitation light may be irradiated quantitatively or intermittently in pulses.

[0054] The photodetection device 80 has the base end of the detection optical waveguide 41 connected to it, and receives the fluorescence received by the light receiving unit 42 of the fluorescence detection unit 40. The photodetection device 80 has a photosensor 81 that converts the received light into an electrical signal, and a calculation unit 82 that performs predetermined calculation processing and can display it as image information on the display device 90. The calculation unit 82 is, for example, a computer equipped with a memory circuit and an calculation circuit. The photodetection device 80 may have a filter that removes excitation light from the detected light and leaves the fluorescence. The filter is, for example, a band-pass filter that leaves light of the fluorescence wavelength, or a filter that identifies and removes pulsed excitation light. The photosensor 81 may be located in the light receiving unit 42. In this case, instead of a fluorescence propagation unit, a cable is provided to transmit the electrical signal converted by the light receiving unit 42 to the photodetection device 80.

[0055] The display device 90 is a monitor capable of displaying visually recognizable images. The display device 90 is connected to the light detection device 80 so that it can receive signals containing image data from the light detection device 80. The images displayed on the display device 90 are image information or character information, etc., acquired by the light detection device 80. The display device 90 displays images based on the data received from the light detection device 80.

[0056] Next, a treatment method using the medical device 10 according to this embodiment will be described. First, a photosensitive substance is administered into the body. The method of administering the photosensitive substance into the body is not particularly limited as long as the photosensitive substance can reach the tumor cells C, but for example, intravascular administration is used, and in this embodiment, intravenous administration is used. Approximately 12 to 36 hours after intravenous administration, the operator inserts the outer casing 20 of the medical device 10 into the vagina V from the vaginal opening, as shown in Figure 9. The operator visually confirms the tip of the outer casing 20 and inserts it from the external os O into the cervical canal CC.

[0057] Next, the operator positions the outer casing 20 so that the emitter 32 and the light-receiving unit 42 are positioned near the tumor cells C. If the emitter 32 and the light-receiving unit 42 are movable relative to the outer casing 20, after positioning the outer casing 20 in place, the emitter 32 and the light-receiving unit 42 can be moved inside the outer casing 20 to the desired position. After this, the operator operates the light source 70 to supply excitation light to the light irradiation unit 30. As a result, as shown in Figure 10, the emitter 32 inside the outer casing 20 can effectively irradiate the tumor cells C located in the cervix U with excitation light. The irradiation direction of the excitation light from the emitter 32 includes the lateral direction Y perpendicular to the axis X of the outer casing 20. Therefore, the emitter 32 can effectively irradiate the tumor cells C located in the cervix U from the cervical canal CC. The excitation light can reach the photosensitive substance adsorbed to the tumor cells C either directly from the emitter 32 or indirectly by being reflected by the outer casing 20 or biological tissue. The operator may irradiate the excitation light while moving the emitter 32 along the axis X inside the outer casing 20.

[0058] When excitation light is irradiated, it reaches photosensitive substances adsorbed to tumor cells C in the cervical U. As a result, the photosensitive substances excited by the excitation light emit fluorescence. When excitation light with an energy level above a certain level is irradiated, a chemical change occurs in the photosensitive substances, and further structural changes in the photosensitive substances cause holes to open in the cell membrane. This destroys the tumor cells C that have been irradiated with the excitation light.

[0059] Since a light-shielding section 50 is positioned at the tip of the emission section 32, the excitation light emitted from the emission section 32 is prevented from directly entering the light-receiving section 42 by the light-shielding section 50. Therefore, even if the emission section 32 and the light-receiving section 42, which are inserted into the narrow space of a living organism, are positioned close together on the same shaft 11, the light-receiving section 42 can detect fluorescence with high sensitivity without being hindered by the excitation light emitted from the emission section 32. If the light-shielding section 50 is equipped with a light-absorbing section 51, the light-shielding section 50 can absorb the excitation light, thereby effectively preventing the excitation light emitted from the emission section 32 from reaching the light-receiving section 42.

[0060] The operator irradiates excitation light from the emitter 32 and, as shown in Figure 11, receives the fluorescence emitted by the photosensitive substance excited by the excitation light with the light-receiving unit 42, which is then detected by the photodetector device 80 (see Figure 1). Since the light-receiving unit 42 can detect fluorescence from the side Y, fluorescence emitted by tumor cells C located in the cervix U can be effectively detected from the cervical canal CC. The operator may also receive fluorescence while irradiating excitation light from the emitter 32 and moving the emitter 32 and light-receiving unit 42 along the axis X. By observing the fluorescence and quenching emitted by the photosensitive substance adsorbed on the tumor cells C from the image displayed on the display device 90, the operator can identify (diagnose) the presence of tumor cells C and the degree of their destruction.

[0061] When the light-shielding section 50 has a reflecting section 52 and a light-absorbing section 51, as shown in the fourth modified example in Figure 7, the excitation light emitted from the emission section 32 is reflected by the reflecting section 52 located on the proximal end side of the light-shielding section 50, allowing it to propagate efficiently over a wide area. Furthermore, since the light-absorbing section 51 is located on the tip side of the light-shielding section 50, the excitation light emitted from the emission section 32 is prevented from directly entering the light-receiving section 42, or indirectly by being reflected by the outer casing 20 or biological tissue. As a result, the medical system 1 can detect fluorescence with high sensitivity using the light-receiving section 42.

[0062] As shown in Figure 3, when the puncture section 22 is separate from the outer casing 20, or as in the first modified example shown in Figure 4, when the puncture section 22 is located at the tip of the outer casing 20, the operator can reach the vicinity of the tumor cells C by piercing the cervix U with the puncture section 22, rather than inserting the shaft 11 into the cervical canal CC of the cervix U. Furthermore, because the light-receiving section 42 is located closer to the tip than the emission section 32 and near the puncture section 22, the depth of the puncture can be kept to a minimum while effectively reaching a position where fluorescence can be received.

[0063] Furthermore, as shown in the third modified example in Figure 6, when the emission surface 33 is formed as a scattering material, the excitation light propagating from the irradiation optical waveguide 31 to the emission section 32 is scattered by the scattering material, allowing irradiation to be carried out over a wide area within the living body.

[0064] Furthermore, this medical system 1 can simultaneously destroy tumor cells C by irradiating them with excitation light and diagnose the lesion site by detecting fluorescence. Diagnosis includes identifying the extent of the lesion containing tumor cells C and confirming the destruction of tumor cells C (confirming their disappearance or reduction).

[0065] The surgeon determines that tumor cells C have been sufficiently destroyed and stops irradiation with excitation light when the display device 90 determines that fluorescence has disappeared or when a predetermined time has elapsed. Determining that fluorescence has disappeared includes confirming that fluorescence has disappeared using the display device 90, or when fluorescence decreases to below a preset threshold (or less than the threshold). The determination of whether tumor cells C have been sufficiently destroyed may be made by the surgeon, but it may also be made automatically by a program provided in the photodetection device 80, etc. The photodetection device 80 may also display the result of the determination on the display device 90.

[0066] As described above, aspect (1) of the present invention, as shown in Figure 2, is a medical device 10 that detects fluorescence emitted by a photosensitive substance excited by excitation light when excitation light is irradiated into a living body, and has a long shaft 11 with an axis X extending from the base end to the tip, the shaft 11 having an emission part 32 that emits excitation light and a light receiving part 42 that receives fluorescence, the tip of the emission part 32 and the tip of the light receiving part 42 are positioned at different locations in the axial direction of the shaft 11, and a light shielding part 50 is positioned between the emission part 32 and the light receiving part 42, at a position that crosses a straight line L extending from the base end side of the emission part 32 to the tip side along the axis X.

[0067] In the embodiment (1) of the present invention configured as described above, the medical device 10 can suppress the direct incidence of excitation light emitted from the emission unit 32 to the light receiving unit 42 by the light shielding unit 50, so that the emission unit 32 and the light receiving unit 42 can be placed close together on the same shaft 11. Therefore, by inserting the shaft 11 equipped with the emission unit 32 and the light receiving unit 42 into the living body, the medical device 10 can achieve both emission of excitation light and reception of fluorescence in the narrow space of the living body, and the light shielding unit 50 placed on the shaft 11 can detect fluorescence with high sensitivity. Furthermore, because the emission unit 32 and the light receiving unit 42 can be placed close together in the medical device 10, the shaft 11 can be made smaller in diameter, and the shaft 11 can be delivered into the living body with minimal invasiveness. In addition, the medical device 10 can achieve both a smaller shaft diameter and irradiation of excitation light over a wide area. Furthermore, the medical device 10 can achieve both a smaller shaft diameter and high detection sensitivity of fluorescence.

[0068] Aspect (2) of the present invention is the medical device 10 described in aspect (1), characterized in that the light-receiving unit 42 is positioned on the tip side of the tip of the emission unit 32. This allows the medical device 10 to effectively bring the light-receiving unit 42 to a position where fluorescence can be received.

[0069] Aspect (3) of the present invention is a medical device 10 as described in aspect (1) or (2), characterized in that the emission surface 33 from which light is emitted from the emission section 32 has a normal component directed in the lateral direction Y perpendicular to the axis X of the shaft 11 (see Figures 2, 3, and 5), or is formed as a light-scattering material (see Figure 4). As a result, the medical device 10 can irradiate a wide area with excitation light emitted from the emission surface 33.

[0070] Aspect (4) of the present invention is a medical device 10 according to any one of aspects (1) to (3), characterized in that the light-shielding portion 50 has a light-absorbing portion 51 that absorbs light facing the tip side and a light-reflecting portion 52 that reflects light facing the proximal end side (see Figure 5). As a result, the medical device 10 can efficiently irradiate a wide area with excitation light by reflecting the excitation light emitted from the emission portion 32 with the light-reflecting portion 52 that faces the side where the emission portion 32 is located. Furthermore, the medical device 10 suppresses the incidence of excitation light on the light-receiving portion 42 by absorbing the excitation light reflected by the tissue or a part of the medical device 10 with the light-absorbing portion 51 that faces the side where the light-receiving portion 42 is located, and the light-receiving portion 42 can detect fluorescence with high sensitivity.

[0071] Aspect (5) of the present invention is a medical device 10 according to any one of aspects (1) to (4), wherein the light-shielding portion 50 has an outer edge portion 53 having a normal component directed in a lateral direction Y perpendicular to the axis X of the shaft 11, and the outer edge portion 53 is an absorbent portion 51 that absorbs light and / or a reflective portion 52 that reflects light. As a result, the medical device 10 can efficiently irradiate a wide area with excitation light by reflecting the excitation light with the reflective portion 52 of the outer edge portion 53. Furthermore, the medical device 10 suppresses the incidence of excitation light on the light-receiving portion 42 by absorbing the excitation light with the absorbent portion 51 of the outer edge portion 53, and the light-receiving portion 42 can detect fluorescence with high sensitivity.

[0072] Aspect (6) of the present invention is a medical device 10 according to any one of aspects (1) to (5), characterized in that the area of ​​the light-receiving surface 43 that receives light from the light-receiving unit 42 is larger than the area of ​​the light-emitting surface 33 that emits light from the light-emitting unit 32, as shown in Figures 2 to 5. As a result, the medical device 10 can effectively receive fluorescence, which has lower energy than excitation light, with the light-receiving surface 43 having a larger area than the light-emitting surface 33.

[0073] Aspect (7) of the present invention is a medical device 10 according to any one of aspects (1) to (6), wherein the shaft 11 has a light-transmitting outer casing 20 that covers the emission section 32 and the light-receiving section 42, and the light-absorbing section 51 is capable of absorbing at least one of the excitation light directly emitted from the emission section 32, the excitation light reflected by the outer casing 20, or the excitation light reflected within the living body. As a result, the medical device 10 suppresses the incidence of excitation light to the light-receiving section 42 by absorbing a portion of the excitation light with the light-absorbing section 51, and the light-receiving section 42 can detect fluorescence with high sensitivity.

[0074] Aspect (8) of the present invention is the medical device 10 described in aspect (7), characterized in that the outer casing 20 has a puncture function at its tip. As a result, the medical device 10 can puncture tissue using the outer casing 20 without using a separate component with a puncture function from the outer casing 20.

[0075] Aspect (9) of the present invention is the medical device 10 described in aspect (7), characterized in that it has a puncture portion 22 that is separate from the outer casing portion 20. As a result, the medical device 10 has an improved operability in tissue puncture because the puncture portion 22 can be operated independently of the outer casing portion 20.

[0076] Aspect (10) of the present invention is a medical device 10 according to any one of aspects (1) to (9), wherein the light-shielding portion 50 has an absorbent portion 51 that absorbs the excitation light emitted from the emission portion 32 and suppresses the direct incidence of the excitation light to the light-receiving portion 42, as shown in Figure 5. As a result, the medical device 10 can suppress the direct incidence of the excitation light to the light-receiving portion 42 by the absorbent portion 51, and the light-receiving portion 42 can detect fluorescence with high sensitivity.

[0077] Aspect (11) of the present invention is a medical device 10 according to any one of aspects (1) to (10), characterized in that the light-shielding portion 50 has a reflecting portion 52 that reflects the excitation light emitted from the emission portion 32 and suppresses the direct incidence of the excitation light to the light-receiving portion 42. As a result, the medical device 10 can suppress the direct incidence of the excitation light to the light-receiving portion 42 by the reflecting portion 52, and the light-receiving portion 42 can detect fluorescence with high sensitivity.

[0078] Aspect (12) of the present invention, as shown in Figures 1 and 2, is a medical system 1 for detecting fluorescence emitted by a photosensitive substance excited by excitation light after irradiating the living body with excitation light, comprising a medical device 10 having a long shaft 11 extending along an axis X from a base to a tip, and a light source 70 connected to the medical device 10, wherein the shaft 11 comprises an emission section 32 for emitting excitation light and a light receiving section 42 for receiving fluorescence, wherein the tip of the emission section 32 and the tip of the light receiving section 42 are positioned at different locations in the axial direction of the shaft, and a light shielding section 50 is positioned between the emission section 32 and the light receiving section 42, at a position that crosses a straight line L extending from the base end side of the emission section 32 to the tip side along the axis X.

[0079] In the medical system 1 configured as described above (12), the light-shielding section 50 prevents the excitation light emitted from the emission section 32 from directly entering the light-receiving section 42, allowing the emission section 32 and the light-receiving section 42 to be placed close together on the same shaft 11. Therefore, by inserting the shaft 11, which includes the emission section 32 and the light-receiving section 42, into the body, the medical system 1 can achieve both emission of excitation light and reception of fluorescence in the narrow space of the body, while the light-shielding section 50 placed on the shaft 11 can detect fluorescence with high sensitivity. Furthermore, because the emission section 32 and the light-receiving section 42 can be placed close together, the shaft 11 can be made smaller in diameter, allowing the shaft 11 to be delivered into the body with minimal invasiveness. In addition, the medical system 1 can achieve both a smaller shaft diameter and irradiation of excitation light over a wide area. Furthermore, the medical system 1 can achieve both a smaller shaft diameter and high detection sensitivity of fluorescence.

[0080] Aspect (13) of the present invention is a medical system 1 as described in aspect (12), characterized in that the light-receiving unit 42 is positioned on the tip side of the tip of the emission unit 32. This allows the medical system 1 to effectively bring the light-receiving unit 42 to a position where fluorescence can be received.

[0081] Aspect (14) of the present invention is a medical system 1 according to aspect (12) or (13), characterized in that it has an optical sensor 81 that converts fluorescence received by a light receiving unit 42 into an electrical signal. As a result, the medical system 1 can convert fluorescence information into an electrical signal, making it easier to transmit and receive fluorescence information and perform calculations.

[0082] Aspect (15) of the present invention is a medical system 1 according to any one of aspects (12) to (14), characterized in that it has a display device 90 that displays information acquired by an optical sensor 81. As a result, the medical system 1 can display the information acquired by the optical sensor 81 on the display device 90 so that the operator or others can understand it visually.

[0083] Aspect (16) of the present invention is a medical system 1 according to any one of aspects (12) to (15), characterized in that it has a light-transmitting puncture section 22 into which a medical device 1 can be inserted. As a result, the medical system 1 can irradiate excitation light from an emission section 32 or receive fluorescence with a light-receiving section 42 via the puncture section 22. In addition, the medical system 1 can protect the emission section 32 and the light-receiving section 42 with the puncture section 22.

[0084] Aspect (17) of the present invention is a medical system 1 according to any one of aspects (12) to (16), characterized in that it has a light-transmitting outer casing 20 that covers the emission unit 32 and the light-receiving unit 42. As a result, the medical system 1 can irradiate excitation light from the emission unit 32 and receive fluorescence with the light-receiving unit 42 via the outer casing 20 that covers the emission unit 32 and the light-receiving unit 42. In addition, the medical system 1 can protect the emission unit 32 and the light-receiving unit 42 with the outer casing 20.

[0085] Aspect (18) of the present invention is the medical system 1 described in aspect (17), characterized in that the outer casing 20 has a puncture function at its tip. As a result, the medical system 1 can puncture tissue using the outer casing 20 without using a separate component with a puncture function from the outer casing 20.

[0086] Aspect (19) of the present invention is a medical system 1 as described in aspect (17), characterized in that it has a puncture section 22 that is separate from the outer casing 20. As a result, the medical system 1 can operate the puncture section 22 independently of the outer casing 20, thereby improving the operability of tissue puncture.

[0087] Furthermore, aspect (20) of the present invention, as shown in Figure 2, is a diagnostic and therapeutic method for detecting fluorescence emitted by a photosensitive substance excited by excitation light by irradiating the living body with excitation light, comprising the steps of administering the photosensitive substance into the body, and after administration, a long shaft 11 having an axis X extending from the base to the tip, the shaft 11 comprising an emission part 32 for emitting excitation light and a light receiving part 42 for receiving fluorescence, wherein the tip of the emission part 32 and the tip of the light receiving part 42 are positioned at different locations in the axial direction of the shaft The medical device 10 is characterized by comprising the steps of: inserting the shaft 11 of the medical device 10, which has a 2 and a light-shielding portion 50 positioned between the light-emitting portion 32 and the light-receiving portion 42, at a position that crosses a straight line L extending from the proximal end portion of the light-emitting portion 32 to the tip portion along the axis X; irradiating a photosensitive substance with excitation light from the light-emitting portion 32 inside the body; and while irradiating with excitation light, receiving the fluorescence emitted by the photosensitive substance in response to the excitation light with the light-receiving portion 42 inside the body.

[0088] In the diagnostic and treatment method of embodiment (20) configured as described above, the light-shielding portion 50 prevents the excitation light emitted from the emission portion 32 from directly entering the light-receiving portion 42, so that the emission portion 32 and the light-receiving portion 42 can be placed close together on the same shaft 11. For this reason, by inserting the shaft 11 equipped with the emission portion 32 and the light-receiving portion 42 into the living body, this diagnostic and treatment method enables both the emission of excitation light and the reception of fluorescence in narrow tissues, while the light-shielding portion 50 located on the shaft 11 can detect fluorescence with high sensitivity.

[0089] It should be noted that the present invention is not limited to the embodiments described above, and various modifications can be made by those skilled in the art within the technical framework of the present invention. Therefore, the medical device 10 according to the embodiment may be used for treatments other than those of the cervix U. [Explanation of Symbols]

[0090] 1. Healthcare system 10 Medical Devices 11 shafts 20 Exterior part 21 Light transmission part 22 Puncture site 30 Light-irradiating section 31 Optical waveguide for irradiation 32. Ejection section 33. Ejection surface 40 Fluorescence detection unit 41 Optical waveguide for detection 42 Light receiving part 43 Photosensitive surface 50 Light-shielding part 51 Light-absorbing section 52 Reflector 53 Outer edge 60 Control section 70 light source 80 Light detection devices 81 Light Sensor 82 Arithmetic section 90 Display Devices C Tumor cells CC Cervix O external cervical os U cervix Vagina X-axis center Y-side direction

Claims

1. A medical device that irradiates a living organism with excitation light and detects fluorescence emitted by a photosensitive substance excited by the excitation light, It has a long shaft with an axis extending from the base to the tip, The aforementioned shaft is The emission unit emits the aforementioned excitation light, The light-receiving unit receives the aforementioned fluorescence, wherein the tip of the emission unit and the tip of the light-receiving unit are positioned at different locations in the axial direction of the shaft, A medical device characterized by having a light-shielding portion positioned between the light-emitting portion and the light-receiving portion, at a position that intersects a straight line extending from the base end portion of the light-emitting portion to the tip end portion along the axis, and positioned between the light-emitting portion and the light-receiving portion.

2. The medical device according to claim 1, characterized in that the light-receiving portion is positioned on the tip side of the light-emitting portion.

3. The medical device according to claim 1 or 2, characterized in that the light-emitting surface of the light-emitting section has a normal component directed in a lateral direction perpendicular to the axis of the shaft, or is formed as a light-scattering material.

4. The medical device according to claim 1 or 2, characterized in that the light-shielding portion has a light-absorbing portion that absorbs light facing the tip side and a light-reflecting portion that reflects light facing the base end side.

5. The light-shielding portion has an outer edge having a normal component that is oriented in a lateral direction perpendicular to the axis of the shaft, and the outer edge is characterized in that it is a light-absorbing portion and / or a light-reflecting portion.

6. The medical device according to claim 1 or 2, characterized in that the area of ​​the light-receiving surface that receives light from the light-receiving unit is larger than the area of ​​the light-emitting surface that emits light from the light-emitting unit.

7. The shaft has an outer casing that is light-transmitting and covers the light-emitting portion and the light-receiving portion. The light-shielding portion has a light-absorbing portion that absorbs light, The medical device according to claim 1 or 2, characterized in that the light-absorbing portion is capable of absorbing at least one of the excitation light directly emitted from the emission portion, the excitation light reflected by the outer casing, or the excitation light reflected within the living body.

8. The medical device according to claim 7, characterized in that the outer casing has a puncture function at its tip.

9. The medical device according to claim 7, characterized in that it has a puncture portion separate from the outer casing.

10. The medical device according to claim 1 or 2, characterized in that the light-shielding portion has a light-absorbing portion that absorbs the excitation light emitted from the emission portion and suppresses the direct incidence of the excitation light to the light-receiving portion.

11. The medical device according to claim 1 or 2, characterized in that the light-shielding portion has a reflecting portion that reflects the excitation light emitted from the emission portion and suppresses the direct incidence of the excitation light to the light-receiving portion.

12. A medical system that irradiates a living organism with excitation light and detects the fluorescence emitted by a photosensitive substance excited by the excitation light, A medical device having a long shaft extending from the base to the tip along its axis, and a light source connected to the medical device, The aforementioned shaft is The emission unit emits the aforementioned excitation light, The light-receiving unit receives the aforementioned fluorescence, wherein the tip of the emission unit and the tip of the light-receiving unit are positioned at different locations in the axial direction of the shaft, A medical system characterized by having a light-shielding portion positioned between the light-emitting portion and the light-receiving portion, at a position that intersects a straight line extending from the base end portion of the light-emitting portion and the tip end portion along the axis, and positioned between the light-emitting portion and the light-receiving portion.

13. The medical system according to claim 12, characterized in that the light receiving unit is positioned on the tip side of the light emitting unit.

14. The medical system according to claim 12 or 13, characterized in that it has a photosensor that converts the fluorescence received by the light receiving unit into an electrical signal.

15. The medical system according to claim 14, characterized in that it has a display device that displays information acquired by the light sensor.

16. The medical system according to claim 12 or 13, characterized in that it has a light-transmitting puncture port into which the medical device can be inserted.

17. The medical system according to claim 12 or 13, further comprising a light-transmitting outer casing that covers the light-emitting portion and the light-receiving portion.

18. The medical system according to claim 17, characterized in that the outer casing has a puncture function at its tip.

19. The medical system according to claim 17, characterized in that it has a puncture portion separate from the exterior portion.