medical devices

Abstract

To provide a medical device capable of maintaining an appropriate irradiation state to an affected area.SOLUTION: A medical device 10 for applying excitation light to a photosensitive substance accumulated in a tumor to destroy the tumor cell, comprises a long shaft part 30 having a distal end and a proximal end, a light emitting part 22 disposed at the distal end of the shaft part 30 and including a light emitting surface 24 for emitting the excitation light of a photosensitive substance, a housing 40 connected to the proximal end of the shaft part 30, and an attitude adjusting part 11 for changing the attitude of the light emitting part 22.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a medical device used in treatment by irradiating a lesion with light. [Background technology]

[0002] Photodynamic therapy and photoimmunotherapy, which use photoreactive substances with tumor cell selectivity, are known as localized cancer treatments (see, for example, Patent Document 1). In particular, treatments using photosensitive substances (hydrophilic phthalocyanines) are expected to specifically destroy target cells without destroying non-target cells such as normal cells by irradiating excitation light (for example, near-infrared light) onto the photosensitive substance accumulated in tumors, thereby achieving a high therapeutic effect while reducing side effects (see Patent Document 2). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2000-7693 [Patent Document 2] Japanese Patent Application Publication No. 2020-138940 Summary of the Invention [Problem to be solved by the invention]

[0004] When irradiating a lesion with light during treatment, the light irradiation state is closely related to the treatment area and therapeutic effect, so maintaining an appropriate light irradiation state is necessary to ensure reliable treatment. However, in actual treatment, it is expected that it will be difficult to maintain an appropriate irradiation state of excitation light for a certain period of time due to spatial constraints, constraints due to position, and constraints on the irradiation area due to the light irradiation method. For this reason, there is a demand for techniques and devices that can maintain an appropriate light irradiation state.

[0005] The present invention has been made to solve the above-mentioned problems, and has an object to provide a medical device that can maintain an appropriate irradiation state of excitation light on a lesion. [Means for solving the problem]

[0006] The medical device according to the present invention, which achieves the above object, is a medical device that irradiates excitation light onto a photosensitive substance accumulated in a tumor to destroy tumor cells, and includes a long shaft portion having a distal end and a proximal end, a light emitting portion that is disposed at the distal end of the shaft portion and has a light emitting surface that emits excitation light for the photosensitive substance, a housing connected to the proximal end of the shaft portion, and an attitude adjusting portion that changes the attitude of the light emitting portion. The shaft portion has two clamping portions that are arranged at the tip end thereof and can move closer to or farther away from each other, the attitude adjustment portion has a clamping operation portion that moves the two clamping portions closer to or farther away from each other, the light emission surface is arranged on at least one of the opposing surfaces of the two clamping portions, and the clamping operation portion has an engaging portion that can release the relative positions of the two clamping portions so that the intervals between the two clamping portions are temporarily fixed at predetermined intervals. do. [Effects of the Invention]

[0007] The medical device configured as described above can change the posture of the light emitting surface located at the tip of the shaft by operating the posture adjustment unit, allowing the light emitting surface to be brought into appropriate contact with the living body and maintaining a stable irradiation state of the excitation light on the lesion area.

[0008] The light emitting section may have a light transmitting section having the light emitting surface and a support section that supports the light transmitting section, and the support section may scatter, diffuse, or reflect light from the light transmitting section side, thereby allowing the light emitting section to efficiently emit the excitation light from the light emitting surface.

[0009] The attitude adjustment unit may have a rotation operation unit that rotates the light emitting unit, whereby by operating the rotation operation unit, the light emitting unit is rotated to change the attitude of the light emitting surface, thereby allowing the light emitting surface to appropriately contact the living body.

[0012] The medical device may have two clamping sections disposed at the distal end of the shaft section and capable of moving closer to or farther away from each other, the attitude adjustment section may have a clamping operation section that moves the two clamping sections closer to or farther away from each other, and the light emitting surface may be disposed on at least one of the opposing surfaces of the two clamping sections. This allows the lesion to be clamped between the light emitting surfaces that irradiate the excitation light and fixed to the lesion, thereby ensuring that the excitation light is irradiated to the lesion.

[0013] The light emitting surface may be disposed on one of the clamping parts, and a light detecting unit capable of detecting the intensity of light may be disposed on the other of the clamping parts, whereby excitation light can be reliably irradiated onto the lesion from one of the clamping parts, while fluorescence emitted by the photosensitive substance exposed to the excitation light is detected by the light detecting unit disposed on the other clamping part, thereby making it possible to recognize the progress of destruction of tumor cells.

[0014] The clamping operation unit may have an engaging unit that can releasably engage the relative positions of the two clamping units, thereby improving operability because the surgeon does not need to maintain the temporarily fixed positions of the two clamping units by his or her own force.

[0015] The clamping operation unit may have a locking unit capable of fixing the relative positions of the two clamping units, thereby allowing the surgeon to fix the positions of the two clamping units with the locking unit, and thus easily maintain the state in which the light emitting surface is in contact with the living body. The engaging portion may have a plurality of gear-like engaging teeth, and the housing may have engaging claws that can engage with the engaging teeth, and the engaging teeth may engage with the engaging claws of the housing at predetermined angles, thereby temporarily fixing the spacing between the two clamping portions at predetermined intervals. The outer surfaces of the housing and the operation clamping portion may be provided with scales that allow the relative positions of the two clamping portions to be grasped. The clamping operation unit may be provided with a locking portion having a locking claw that can engage with the front engagement teeth, and the clamping operation unit may become inoperable when the locking claw is inserted between the engagement teeth of the engagement portion. The locking claw may be positioned inside the housing so that it can engage with and disengage from the engagement portion, and a portion of the locking portion may protrude outside the housing so that it can be operated from outside the housing and slid relative to the housing. The two clamping sections may be capable of moving relatively closer to or farther away from each other while maintaining a parallel state by operating the clamping operation section. [Brief explanation of the drawings]

[0016] [Figure 1] FIG. 1 is a perspective view showing a medical device according to a first embodiment. [Figure 2] FIG. 2 is a perspective view of the vicinity of a light emitting portion of the medical device. [Figure 3] FIG. 2 is a plan view of the vicinity of a light emitting portion of the medical device. [Figure 4] 4A and 4B are views showing the vicinity of a light emitting portion of a medical device, in which (A) is a longitudinal cross-sectional view taken along line AA in FIG. 3, and (B) is a transverse cross-sectional view taken along line BB in FIG. [Figure 5] 10A to 10D are cross-sectional views showing modified examples of the light emitting portion of the medical device, where (A) shows a first modified example, (B) shows a second modified example, (C) shows a third modified example, and (D) shows a fourth modified example. [Figure 6] 10A and 10B are longitudinal cross-sectional views showing modified examples of the light emitting portion of a medical device, where (A) shows the fifth modified example, (B) shows the sixth modified example, (C) shows the seventh modified example, (D) shows the eighth modified example, and (E) shows the ninth modified example. [Figure 7] 10A and 10B are plan views showing modified examples of the light emitting portion of the medical device, where (A) shows a tenth modified example and (B) shows an eleventh modified example. [Figure 8] 13A and 13B are cross-sectional views showing a twelfth modified example of a medical device, in which (A) shows the light emitting portion in its natural state, and (B) shows the light emitting portion housed in a tubular portion. [Figure 9] FIG. 10 is a longitudinal cross-sectional view showing a state in which excitation light is irradiated onto a lesion from a light emitting surface. [Figure 10] FIG. 10 is a perspective view showing a medical device according to a second embodiment. [Figure 11] 1A and 1B are plan views of the vicinity of the clamping parts, in which (A) shows a state in which the two clamping parts are spaced apart, and (B) shows a state in which the two clamping parts are close to each other. [Figure 12] 1A and 1B are diagrams showing an example of a movement mechanism, in which (A) shows a state in which two clamping units are spaced apart, and (B) shows a state in which the two clamping units are close to each other. [Figure 13] FIG. [Figure 14] 10A and 10B are plan views showing the vicinity of the clamping portion of modified examples of the medical device, where (A) shows a thirteenth modified example and (B) shows a fourteenth modified example. [Figure 15] 10A to 10C are plan views showing the vicinity of the clamping portion of modified examples of the medical device, where (A) shows the 15th modified example, (B) shows the 16th modified example, and (C) shows the 17th modified example. [Figure 16] FIG. 2 is a plan view showing a state in which excitation light is irradiated onto a lesion from a light exit surface. DETAILED DESCRIPTION OF THE INVENTION

[0017] Hereinafter, embodiments of the present invention will be described with reference to the drawings. For convenience of explanation, the dimensions of the drawings may be exaggerated and may differ from the actual dimensions. Furthermore, in this specification and the drawings, components having substantially the same functional configurations are designated by the same reference numerals, and redundant explanations will be omitted. In this specification, the side of the device that comes into contact with the living body will be referred to as the "distal side," and the side that is operated will be referred to as the "proximal side."

[0018] First Embodiment The medical device 10 according to the first embodiment is used to treat tumors. While the type of tumor is not particularly limited, it can be applied to gynecological cancers such as uterine cancer and ovarian cancer. The medical device 10 is used in photoimmunotherapy, which destroys target cells by irradiating a photosensitizer accumulated in tumor cells with near-infrared light, which is the excitation light for the photosensitizer. The target cells are tumor cells, such as cancer cells or cells of precancerous lesions. In this treatment method, an antibody that specifically binds only to a unique antigen on the surface of tumor cells and a photosensitizer bound to the antibody are used as drugs. The antibody is not particularly limited, but examples include panitumumab, trastuzumab, HuJ591, pertuzumab, lapatinib, palbociclib, and olaparib. The photosensitizer is, for example, but not limited to, hydrophilic phthalocyanine, a substance that reacts to near-infrared light with a wavelength of approximately 700 nm (IR700). When IR700 is exposed to near-infrared light with a wavelength of approximately 660-740 nm, the functional ligands that ensure its water solubility are cleaved, causing a conformational change from water-soluble to hydrophobic. This conformational change pulls out membrane proteins, creating holes in the cell membrane and allowing water to enter the cell, rupturing and destroying tumor cells. IR700 is also 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 conformational change while emitting fluorescence in response to light, and ceases to emit fluorescence once it has destroyed tumor cells and fulfilled its role as a drug.

[0019] The medical device 10 of this embodiment is configured to be suitable for treatment of tumor cells by laparotomy or laparoscopy. As shown in FIG. 1 , the medical device 10 of this embodiment includes a light irradiation unit 20 that irradiates excitation light for a photosensitizer, a housing 40 that is manually operated by the surgeon, a shaft unit 30 that extends from the housing 40 toward its tip, and a tubular unit 50 that extends from the housing 40 toward its tip and covers the shaft unit 30. The medical device 10 also includes an attitude adjustment unit 11 that adjusts the attitude of the light irradiation unit 20. A rotation operation unit 51 that constitutes the attitude adjustment unit 11 is provided on the proximal end side of the tubular unit 50, and the shaft unit 30 can be rotated around its axis.

[0020] As shown in FIGS. 2 to 4 , the light irradiation unit 20 has a long irradiation optical waveguide 21 and a light emitting unit 22 arranged on the distal end side of the irradiation optical waveguide 21. The irradiation optical waveguide 21 is a long wire rod that propagates light. The irradiation optical waveguide 21 is formed of, for example, a single optical fiber. The irradiation optical waveguide 21 may be formed of a plurality of optical fibers. The irradiation optical waveguide 21 is arranged inside the shaft unit 30, and the proximal end of the irradiation optical waveguide 21 is connectable to a light output device (not shown) that outputs light. The irradiation optical waveguide 21 can receive near-infrared rays, which are excitation light for photosensitizers, from the light output device and propagate the near-infrared rays to the light emitting unit 22. The irradiation optical waveguide 21 may be formed of an optical waveguide other than an optical fiber.

[0021] The light emitting section 22 has a light emitting section 23, a light transmitting section 25 having a light emitting surface 24 that receives light from the light emitting section 23 and emits light in a planar manner, and a support section 26 that supports the light transmitting section 25 so that the light emitting surface 24 is exposed to the outside.

[0022] The light emitting unit 23 is a cylindrical diffuser that is connected to the cut end of the optical fiber and diffuses the light received from the optical fiber. The light emitting unit 23 may be formed integrally with the optical fiber that forms the irradiation optical waveguide 21 by processing the surface or the inside of the optical fiber. The light emitting unit 23 may also be the cut end of the optical fiber. The light emitting unit 23 may be formed by a mirror and / or a lens placed on the cut end of the optical fiber. The light emitting unit 23 may be an LED or the like that emits light using electricity. A plurality of light emitting units 23 (for example, three) may be provided as shown in FIG. 5(A).

[0023] As shown in FIGS. 2 to 4 , the support portion 26 is formed in a cup shape to accommodate the light-transmitting portion 25, and the tip of the shaft portion 30 is connected to the support portion 26. The support portion 26 can rotate together with the shaft portion 30 by rotating the rotation operation unit 51. The support portion 26 accommodates the light-emitting portion 23 and the light-transmitting portion 25, and the light-emitting surface 24 of the light-transmitting portion 25 is exposed to the outside. The shape of the support portion 26 is not particularly limited as long as the light-emitting surface 24 of the supported light-transmitting portion 25 can be exposed to the outside and brought into contact with a living body. The inner surface of the support portion 26 may be coated with a scattering (diffusion) coating to diffuse (scatter) the light emitted by the light-emitting portion 23. In the scattering (diffusion) coating, the inner surface of the support portion 26 is coated with a light-diffusing or light-scattering material. Examples of the light-diffusing or light-scattering material include TiO microparticles and PS microparticles. In the diffusion (scattering) coating, the inner surface of the support portion 26 itself may be formed with minute irregularities. The inner surface of the support portion 26 may be coated with a reflective coating that specularly reflects the excitation light emitted by the light-emitting portion 23, or the inner surface structure of the support portion 26 itself may be a reflector. The inner surface of the support portion 26 preferably has a curved shape that is concave toward the light-emitting surface 24 so that the excitation light emitted by the light-emitting portion 23 can be efficiently and uniformly reflected toward the light-emitting surface 24. For example, as shown in FIG. 4(A), the inner surface of the support portion 26 has a curved shape in a cross section perpendicular to the axis of the shaft portion 30. Alternatively, as shown in FIG. 5(B), the inner surface of the support portion 26 may have a shape with corners rather than a curved shape in a cross section perpendicular to the axis of the shaft portion 30, and the cross section of the light-transmitting portion 25 may be rectangular. Alternatively, as shown in FIG. 6(A), the inner surface of the support portion 26 may have a curved shape in a cross section parallel to the axis of the shaft portion 30. Alternatively, the inner surface of support portion 26 may have a curved shape that is concave toward light exit surface 24 in both a cross section perpendicular to the axis of shaft portion 30 and a cross section parallel to the axis of shaft portion 30. The material of support portion 26 preferably has a certain degree of strength, and suitable materials for example include metals such as stainless steel and resins such as ABS resin.

[0024] The light-transmitting portion 25 is formed of a transparent or translucent material that can transmit light. The light-transmitting portion 25 is housed inside the support portion 26. As shown in FIGS. 2 to 4, the light-transmitting portion 25 has a housing hole 27 that houses the light-emitting portion 23. The light-transmitting portion 25 is not like a balloon that expands and contracts as liquid flows in and out of it, but is formed of a solid with a structure that does not allow material to flow in or out due to expansion and contraction. The light-transmitting portion 25 has a light-emitting surface 24 on the surface corresponding to the opening of the support portion 26. The light-emitting portion 23 is inserted into the housing hole 27, and light can be received from the light-emitting portion 23 and emitted from the light-emitting surface 24. The gap between the housing hole 27 and the light-emitting portion 23 is preferably filled with a material (e.g., gel) with a refractive index that matches or is close to that of the light-transmitting portion 25. This prevents light emitted from the light-emitting portion 23 from being reflected without entering the light-transmitting portion 25. The material of the light transmitting portion 25 is a transparent or translucent material, and suitable examples include resins such as acrylic, polycarbonate, PET, and polystyrene, elastomers such as silicone, TPU, TPE, and PVC, and glass. The material forming the light transmitting portion 25 may be hard or soft, but using a soft material can reduce the risk of damaging the surface of the living body.

[0025] The light-transmitting portion 25 may be made of the transparent or translucent material described above, mixed with a light-diffusing or light-scattering material that diffuses or scatters light. The light-diffusing or light-scattering material may be, for example, TiO fine particles or PS fine particles. The light-diffusing or light-scattering material may also be air bubbles. Alternatively, the light-transmitting portion 25 may have minute irregularities formed on the contact surface with the support portion 26 or on the light-emitting surface 24, which diffuses or scatters light.

[0026] The light emitting surface 24 of the light transmitting portion 25 is a plane that emits light from the surface. The light emitting surface 24 emits excitation light in a direction substantially perpendicular to the axis of the shaft portion 30. The light emitting surface 24 is in close contact with the lesion and emits the excitation light directly to the lesion. The area of ​​the light emitting surface 24 is, for example, 200 mm 2 ~800mm 2For example, the length of the light exit surface 24 along the axis of the shaft portion 30 is 20 mm to 40 mm, and the width in the direction perpendicular to the axis of the shaft portion 30 is 10 mm to 20 mm.

[0027] Note that at least a portion of the light emitting surface 24 does not have to be flat. For example, as in the modified example shown in FIG. 5(C), the light emitting surface 24 may have a groove-like recess 28 formed in the center of the light emitting surface 24 in a direction perpendicular to the axis of the shaft portion 30, extending along the axis of the shaft portion 30. Alternatively, as in the modified example shown in FIG. 6(B), the light emitting surface 24 may have a groove-like recess 28 formed in the center of the light emitting surface 24 in a direction perpendicular to the axis of the shaft portion 30, extending along the axis of the shaft portion 30. If the light emitting surface 24 has the recess 28, it is easy to position the light emitting surface 24 relative to the raised lesion, and the light transmitting surface can easily come into close contact with the raised lesion, allowing the excitation light to be efficiently irradiated onto the lesion. Furthermore, the center of the light emitting surface 24 may have an overall concave shape.

[0028] 5(D), the light emitting surface 24 may be convex, which makes it easy to position the light emitting surface 24 relative to the depressed portion at the base of the raised lesion, allowing the excitation light to be efficiently irradiated onto the lesion.

[0029] Furthermore, light transmitting portion 25 having convex light emitting surface 24 may be flexible. This allows light emitting surface 24 to be pressed against the raised lesion and deformed to fit the shape of the lesion. This makes it easier for light emitting surface 24 to come into close contact with the raised lesion, allowing excitation light to be efficiently irradiated onto the lesion.

[0030] Alternatively, both the support portion 26 and the light-transmitting portion 25 may be flexible. For example, the support portion 26 may be made of a flexible white silicone resin with high reflectivity, and the light-transmitting portion 25 may be made of a flexible transparent silicone resin.

[0031] 6(C), the light transmitting section 25 may not have the accommodation hole 27 formed therein, and light may be incident from the light emitting section 23, which is the end of the irradiation optical waveguide 21. A lens 29 for assisting diffusion may be provided at the end of the irradiation optical waveguide 21, as in the modification shown in FIG. 6(D). In these configurations in which no accommodation hole is provided, the inner surface of the light transmitting section 25 or the support section 26 preferably has the above-described structure for diffusing or scattering light.

[0032] 6(E), the light transmitting portion 25 may have the accommodation hole 27 formed along the axis of the shaft portion 30 up to approximately the center of the light transmitting portion 25. The light emitting portion 23 is a cut end facing the inner surface of the support portion 26 at approximately the center of the light transmitting portion 25, or a lens 29 connected to the cut end. As a result, light emitted from the light emitting portion 23 is irradiated onto the inner surface of the support portion 26 at the center of the light transmitting portion 25, reflected and diffused (scattered) on the inner surface, and emitted uniformly from the light emitting surface 24. If the light transmitting portion 25 contains a light scattering material or a light diffusing material, the light emitted from the light emitting surface 24 is further uniformed.

[0033] Furthermore, the light exit surface 24 and the supporting portion 26 around it do not have to be rectangular, as in the modified example shown in FIG. 7(A), and may be circular or elliptical, for example.

[0034] 7(B), the light-transmitting portion 25 may be formed with a curved accommodation hole 27. The light-emitting portion 23 is a cylindrical diffuser curved inside the accommodation hole 27. This allows the light-emitting portion 23 to be arranged over a wide range of the light-transmitting portion 25, and allows the excitation light to be emitted uniformly from the light-emitting surface 24.

[0035] 8(A), the medical device 10 may have a flat support portion 26 and a flat light-transmitting portion 25 arranged to overlap the support portion 26. The support portion 26 has a groove-shaped bending guide portion 26A that facilitates bending, formed along the axis of the shaft portion 30 at approximately the center of the surface of the support portion 26 opposite the surface that contacts the light-transmitting portion 25. An elastically deformable shape-retaining portion 26B is sandwiched and arranged between the contact surface of the support portion 26 and the light-transmitting portion 25. The shape-retaining portion 26B is, for example, a shape-memory alloy such as a Ni-Ti alloy. The shape-retaining portion 26B is preferably arranged to surround the vicinity of the outer periphery of the contact surface of the support portion 26 and the light-transmitting portion 25. As shown in FIG. 8(B), the support portion 26 and the light-transmitting portion 25 can be bent along the groove-shaped bending guide portion 26A to be deformed into an elongated shape. Support section 26 and light transmission section 25 are deformed into an elongated shape and transported to the vicinity of the lesion while being housed inside tubular section 50, and then released from tubular section 50, where they can return to their original shapes. At this time, shape-retaining section 26B, which has been elastically deformed, elastically returns to its original shape, making it easy for support section 26 and light transmission section 25 to return to their original shapes. Note that bend guide section 26A and shape-retaining section 26B do not necessarily have to be provided.

[0036] As shown in Figure 1, the housing 40 has a housing main body 55 provided with a gripping portion 52 to be held by the surgeon, an advance / retreat movement operation portion 53 with which the surgeon controls the protruding state of the shaft portion 30 from the tubular portion 50, and an irradiation operation portion 54 with which the surgeon controls the emission of excitation light from the light emitting portion 22.

[0037] The advance / retract movement operation unit 53 is rotatably connected to the housing body 55. The advance / retract movement operation unit 53 is connected to the base end of the shaft portion 30 inside the housing body 55. The shaft portion 30 is rotatably connected to the advance / retract movement operation unit 53 so that rotation about its axis is not hindered. When the surgeon moves the advance / retract movement operation unit 53 while holding the grip portion 52, the shaft portion 30 can move advance / retract along its axis. Therefore, the surgeon can move the shaft portion 30 in and out of the tip of the tubular portion 50 by operating the advance / retract movement operation unit 53. The shaft portion 30 can also rotate by receiving a rotational force from the rotation operation unit 51.

[0038] When the operator operates the irradiation operation unit 54, the light output unit 22 outputs excitation light from a light output unit (not shown) in the housing 40 to the irradiation optical waveguide 21. The light output unit may be disposed outside the housing 40.

[0039] The shaft portion 30 protruding from the tubular portion 50 has a shape curved in one direction. This allows the light emitting portion 22 to be directed in various directions by operating the rotation operation portion 51 to rotate the shaft portion 30 around its axis. The shaft portion 30 is formed of a deformable material, and can assume a linear shape when stored in the tubular portion 50. Then, by operating the advance / retreat movement operation portion 53 to cause the curved portion of the shaft portion 30 to protrude from the tubular portion 50, the shaft portion 30 can be bent.

[0040] The rotation operation unit 51 that rotates the light emitting unit 22, the advance / retract movement operation unit 53 that moves the light emitting unit 22 forward / retract, and the advance / retract movement operation unit 53 (bending operation unit) that bends the shaft unit 30 constitute the attitude adjustment unit 11 that adjusts the attitude of the light emitting unit 22.

[0041] The medical device 10 of this embodiment irradiates excitation light by bringing the surface-emitting light emitting light exit surface 24 into contact with a living body, and is therefore suitable for application to elevated lesions or infiltrated lesions.

[0042] Next, a treatment method using the medical device 10 according to the first embodiment will be described.

[0043] First, a photosensitizer is administered into the body. The method for administering the photosensitizer into the body is not particularly limited as long as it can deliver the photosensitizer to tumor cells, but may be, for example, intravascular administration, which in this embodiment is intravenous administration. Approximately 12 to 36 hours after intravenous administration, light irradiation treatment is performed using the medical device 10 of this embodiment.

[0044] In this embodiment, the surgeon approaches the lesion by laparotomy or laparoscopy, as described above. The surgeon approaches the lesion using an endoscope. The surgeon inserts the tubular portion 50, which houses the distal end portion having the light emitting surface 24 of the medical device 10, into the living body. When the distal end reaches the vicinity of the lesion, the surgeon operates the advance / withdrawal operation unit 53 to protrude the shaft portion 30, the support portion 26, and the light emitting portion 22 from the tubular portion 50. The surgeon then operates the rotation operation unit 51 to change the orientation of the support portion 26, bringing the light emitting surface 24 of the light transmission unit 25 supported by the support portion 26 into contact with the periphery of the lesion L, as shown in FIG. 9 . This positions the light emitting surface 24 so that it faces the lesion L. By maintaining the light emitting surface 24 in close contact with the living body, the distance between the lesion L and the light emitting surface 24 can be maintained constant. In this state, the surgeon operates the light output device and / or the irradiation operation unit 54 of the housing 40 to supply excitation light to the light emitting unit 22. This allows the excitation light to be irradiated onto the lesion L from the light emitting surface 24 of the light emitting unit 22.

[0045] When excitation light is irradiated, it reaches the photosensitive substance accumulated in the tumor. This causes a chemical change in the photosensitive substance, which then undergoes a structural change, opening holes in the cell membrane. This destroys the tumor cells irradiated with the excitation light.

[0046] While irradiating excitation light from the light irradiation unit 20, the surgeon can confirm the fluorescence emitted by the photosensitive material excited by the excitation light. The fluorescence can be confirmed via the light-transmitting unit 25 and the irradiation optical waveguide 21, which have translucency. That is, the irradiation light-transmitting unit 25 and the irradiation optical waveguide 21 are also used for detecting fluorescence, and the fluorescence detected via the irradiation optical waveguide 21 is displayed on, for example, an external display device (not shown), thereby confirming the fluorescence. Note that, to confirm the fluorescence, a light detecting unit capable of detecting the intensity of light may be disposed inside the light-transmitting unit 25 or near the support unit 26. When detecting the fluorescence, not only the fluorescence but also the excitation light can be detected, thereby confirming the irradiation state of the excitation light.

[0047] The surgeon determines that the tumor cells have been sufficiently destroyed in the area irradiated with the excitation light when the display device determines that the fluorescence has disappeared or when a predetermined time has passed. If other tumor cells are present, the surgeon brings the light emitting surface 24 into contact with the periphery of another lesion L and irradiates the other lesion L with the excitation light.

[0048] As described above, the medical device 10 of this embodiment is a medical device 10 that irradiates excitation light onto photosensitive substances accumulated in tumors to destroy tumor cells, and includes a long shaft portion 30 with a tip portion and a base portion, a light emitting portion 22 that is arranged at the tip portion of the shaft portion 30 and has a light emitting surface 24 that emits excitation light for the photosensitive substance, a housing 40 connected to the base portion of the shaft portion 30, and an attitude adjustment portion 11 that changes the attitude of the light emitting portion 22.

[0049] The medical device 10 configured as described above can change the posture of the light emitting surface 24 located at the tip of the shaft portion 30 by operating the posture adjustment unit 11, so that the light emitting surface 24 can be brought into appropriate contact with the living body, and the irradiation state of the excitation light on the lesion L can be stably maintained.

[0050] The light emitting section 22 has a light transmitting section 25 having a light emitting surface 24 and a supporting section 26 that supports the light transmitting section 25. The supporting section 26 scatters, diffuses, or reflects light from the light transmitting section 25 side. This allows the light emitting section 22 to efficiently emit excitation light from the light emitting surface 24.

[0051] The attitude adjustment unit 11 has a rotation operation unit 51 that rotates the light emitting unit 22. Thus, by operating the rotation operation unit 51, the light emitting unit 22 is rotated to change the attitude of the light emitting surface 24, and the light emitting surface 24 can be brought into appropriate contact with the living body.

[0052] The posture adjustment unit 11 has a bending operation unit (advance / retreat movement operation unit 53) that bends the shaft portion 30. Thus, by operating the bending operation unit, the shaft portion 30 is bent to change the posture of the light emitting surface 24, and the light emitting surface 24 can be brought into appropriate contact with the living body.

[0053] The posture adjustment unit 11 has an advance / retract movement operation unit 53 that moves the light emitting unit 22 along the axis of the shaft unit 30. Thus, by operating the advance / retract movement operation unit 53, the light emitting unit 22 is moved to change the posture of the light emitting surface 24, and the light emitting surface 24 can be brought into appropriate contact with the living body.

[0054] Second Embodiment The medical device 10 according to the second embodiment differs from the first embodiment in that it has two clamping portions 60 that clamp the lesion L, and at least one of the clamping portions 60 is provided with a light emitting portion 22.

[0055] As shown in FIGS. 10 to 13 , the medical device 10 has two clamping units 60 connected to the tip of the shaft unit 30, and a clamping operation unit 70 for operating the two clamping units 60 is provided in the housing 40. The clamping operation unit 70 constitutes a part of the attitude adjustment unit 11. The two clamping units 60 are substantially parallel and can be moved closer to or farther away from each other. The two clamping units 60 can be moved closer to or farther away from each other while maintaining their parallel state by a moving mechanism 61, such as a parallel crank mechanism (see FIG. 12 ). The moving mechanism 61 is connected to an operating wire 62 that moves forward and backward by operating the clamping operation unit 70 provided in the housing 40. As the operating wire 62 moves along the axis of the shaft unit 30, the moving mechanism 61 can move the two clamping units 60 closer to or farther away from each other while maintaining their parallel state.

[0056] A light transmitting portion 25 having a light emitting surface 24 and a support portion 26 that supports the light transmitting portion 25 are arranged on one side of the clamping portions 60. The light emitting surface 24 is arranged on the opposing surface side of the two clamping portions 60. The size of the light emitting surface 24 is, for example, 20 mm in length along the axis of the shaft portion 30 and 10 mm in length in a direction perpendicular to the axis of the shaft portion 30. The distance between the two clamping portions 60 can be changed, for example, between 0 mm and 20 mm.

[0057] The clamping operation unit 70 has a structure in which the two clamping units 60 provide a tactile response or a temporary stop at a predetermined interval (e.g., 5 mm). For example, the clamping operation unit 70 has an engagement unit 72 with multiple gear-like engagement teeth 71 so that it can engage with the housing 40 at predetermined angles, and the housing main body 55 has an engagement claw 73 that can engage with any of the engagement teeth 71 on the engagement unit 72. The engagement claw 73 is elastically deformable. The engagement teeth 71 deform and overcome the engagement claw 73, allowing the clamping operation unit 70 to provide a tactile response and a temporary stop. Furthermore, the outer surfaces of the housing main body 55 and the operating clamping unit 60 are provided with scales 74 that allow the surgeon to grasp their relative positions. This allows the surgeon to recognize the distance between the two clamping units 60. The clamping operation unit 70 also has a locking unit 76 with a locking claw 75 that can engage with any of the engagement teeth 71 on the engagement unit 72. The locking claw 75 is a rigid body and is disposed inside the housing body 55 so as to be able to engage with or disengage from the engaging portion 72. The locking portion 76 is slidable relative to the housing body 55, with a portion of the locking portion 76 protruding outside the housing body 55. The surgeon can operate the locking portion 76 from outside the housing body 55 to slide it relative to the housing body 55. This causes the locking claw 75 to be inserted between the engaging teeth 71 of the engaging portion 72, rendering the operation clamping portion 60 inoperable and maintaining the distance between the two clamping portions 60. This makes it easy to maintain the light emitting surface 24 in contact with the living body. Note that the structure that generates a tactile response and the structure that temporarily stops the clamping operation portion 70 are not limited to the structures described above.

[0058] The two clamping units 60 do not have to be able to move toward or away from each other in parallel. For example, as shown in Fig. 14(A), the two curved clamping units 60 may be moved toward or away from each other so as to open and close while tilting as the operating wire 62 moves along the axis of the shaft unit 30.

[0059] Furthermore, the movement mechanism 61 that moves the two clamping units 60 toward or away from each other in parallel may be a mechanism that moves only one of the clamping units 60, as shown in FIG. 14(B), for example.

[0060] 15(A), the support section 26 and the light transmitting section 25 may be provided on both of the clamping sections 60. This allows the excitation light to be irradiated onto the lesion L effectively.

[0061] 15(B), the illumination optical waveguide 21 may be led out from the outside of the clamping unit 60. In addition, as shown in FIG.

[0062] 15(C), the light emitting surface 24 may be disposed on one clamping unit 60, and a light detecting unit 80 capable of detecting the intensity of light may be disposed on the other clamping unit 60. The light detecting unit 80 can detect the excitation light that has passed through the lesion L and / or the fluorescence emitted by the photosensitive substance excited by the excitation light. Note that the position of the light detecting unit 80 is not particularly limited as long as it can detect the fluorescence emitted by the photosensitive substance.

[0063] Furthermore, a pressure sensor for detecting the clamping force may be provided in at least one of the two clamping units 60. This allows the surgeon to recognize the clamping force, making it easier to maintain the state in which the light emitting surface 24 is in contact with the living body.

[0064] The treatment method using the medical device 10 of the second embodiment is similar to the treatment method using the medical device 10 of the first embodiment in the steps prior to the light irradiation treatment. In this embodiment, the surgeon approaches the lesion L via laparotomy or laparoscopy. The surgeon inserts the tubular body housing the clamping units 60 into the living body. When the clamping units 60 reach the vicinity of the lesion L, the surgeon protrudes the clamping units 60 from the tubular units 50 and operates the clamping operation units 70 to separate the two clamping units 60. Next, the surgeon operates the rotation operation unit 51 to change the orientation of the light emitting surfaces 24, and brings the light emitting surfaces 24 of the clamping units 60 into contact with the periphery of the lesion L. Next, while checking the scale 74, the surgeon operates the clamping operation units 70 to clamp the raised lesion L with the clamping units 60, as shown in FIG. 16 . Then, with the light emitting surface 24 in an appropriate state of contact with the protruding lesion L, the operator operates the locking unit 76 to fix the positions of the two clamping units 60. This allows the operator to maintain the light emitting surface 24 in contact with the living body. In this state, the operator operates the irradiation operation unit 54 of the housing 40 to supply excitation light to the light irradiation unit 20. This allows the excitation light to be irradiated from the light emitting surface 24 to the lesion L. The subsequent steps are the same as those in the treatment method of the first embodiment.

[0065] As described above, the medical device 10 according to the second embodiment has two clamping sections 60 that are arranged at the distal end of the shaft section 30 and can move closer to or farther away from each other, the attitude adjustment section 11 has a clamping operation section 70 that moves the two clamping sections 60 closer to or farther away from each other, and the light emitting surface 24 is arranged on at least one of the opposing surfaces of the two clamping sections 60. This allows the lesion L to be clamped by the light emitting surface 24 that irradiates the excitation light, and the light emitting surface 24 to be fixed to the lesion L, so that the excitation light can be reliably irradiated onto the lesion L.

[0066] Alternatively, the light emitting surface 24 may be disposed on one side of the clamping unit 60, and a light detecting unit 80 capable of detecting the intensity of light may be disposed on the other side of the clamping unit 60. This allows the excitation light to be reliably irradiated onto the lesion L from one clamping unit 60, while the fluorescence emitted by the photosensitive substance exposed to the excitation light is detected by the light detecting unit 80 from the other clamping unit 60, thereby making it possible to recognize the progress of destruction of tumor cells.

[0067] Furthermore, the clamping operation unit 70 has an engaging unit 72 that can releasably engage the relative positions of the two clamping units 60. This eliminates the need for the surgeon to maintain the temporarily fixed positions of the two clamping units 60 with their own strength, improving operability.

[0068] Furthermore, the clamping operation unit 70 has a locking unit 76 that can fix the relative positions of the two clamping units 60. This allows the surgeon to fix the positions of the two clamping units 60 using the locking unit 76, making it possible to easily maintain the state in which the light emitting surface 24 is in contact with the living body.

[0069] The present invention is not limited to the above-described embodiment, and various modifications may be made by those skilled in the art within the technical spirit of the present invention. For example, the configurations described in this specification may be combined as appropriate. [Explanation of symbols]

[0070] 10 Medical Devices 11 Posture adjustment section 20 Light irradiation unit 21 Optical waveguide for irradiation 22 Light output section 23 Light-emitting part 24 Light exit surface 25 Light transmission part 26 Support part 27 Receiving hole 28 Recess 29 Lenses 30 Shaft section 40 cabinets 50 Tubular part 51 Rotation control unit 52 Gripping part 53 Advance / retreat movement operation unit (curve operation unit) 54 Irradiation operation section 55 Housing body 60 Clamping part 61 Moving mechanism 62 Control wire 70 Clamping operation part 71 Engagement teeth 72 Engagement part 73 Engagement claw 74 scales 75 Locking Claw 76 Rock Club 80 Light detection unit

Claims

1. A medical device that destroys tumor cells by irradiating a photosensitive substance accumulated in a tumor with excitation light, an elongated shaft portion having a distal end and a proximal end; a light emitting portion disposed at a tip end of the shaft portion and having a light emitting surface that emits excitation light for the photosensitizer; a housing connected to a base end of the shaft portion; an attitude adjustment unit that changes the attitude of the light emitting unit, two clamping portions disposed at the tip of the shaft portion and capable of moving closer to or farther away from each other; the attitude adjustment unit has a clamping operation unit that moves the two clamping units closer to or farther apart, the light exit surface is disposed on at least one of the opposing surfaces of the two clamping portions, The clamping operation unit is a medical device having an engagement unit that can release the relative positions of the two clamping units so that the spacing between the two clamping units is temporarily fixed at predetermined intervals.

2. the light emitting portion includes a light transmitting portion having the light emitting surface; a support portion that supports the light transmitting portion, The medical device according to claim 1 , wherein the support portion scatters, diffuses, or reflects light from the light-transmitting portion side.

3. The medical device according to claim 1 or 2, wherein the attitude adjustment unit has a rotation operation unit that rotates the light emitting unit.

4. The light exit surface is disposed on one of the clamping portions, The medical device according to any one of claims 1 to 3, wherein a light detecting unit capable of detecting the intensity of light is disposed on the other of the clamping units.

5. 5. The medical device according to claim 1, wherein the clamping operation section has a locking section that can fix the relative positions of the two clamping sections.

6. The engaging portion has a plurality of gear-like engaging teeth, the housing has an engagement claw that can be engaged with the engagement tooth, A medical device according to any one of claims 1 to 4, wherein the engagement teeth engage with the engagement claws of the housing at predetermined angles, thereby temporarily fixing the spacing between the two clamping portions at predetermined intervals.

7. A medical device as described in Claim 6, wherein the outer surfaces of the housing and the operating clamping portion are provided with scales that allow the relative positions of the two clamping portions to be grasped.

8. The clamping operation unit includes a locking unit having a locking claw that can engage with the front engaging tooth, The medical device according to claim 6 or 7, wherein the clamping operation portion is rendered inoperable by the locking claw being inserted between the engagement teeth of the engagement portion.

9. The locking claw is disposed inside the housing so as to be able to engage with and disengage from the engaging portion, The medical device according to claim 8 , wherein a portion of the locking portion protrudes outside the housing and can be operated from outside the housing to slide relative to the housing.

10. A medical device described in any one of claims 1 to 9, wherein the two clamping portions can be moved relatively closer or farther apart while maintaining a parallel state by operating the clamping operating portion.

Images