Medical markers

Abstract

In order to provide a medical marker having excellent mounting stability, improved possible indwelling period, and excellent visibility from outside a luminal organ, this medical marker 100 comprises a main body member 110 having a projection 111 configured such that a tip 111a thereof elastically deforms due to a force applied in the axial direction from the tip side, and a flange 112 formed continuously with the proximal peripheral edge of the projection 111. At least a part or all of the projection 111 and the flange 112 constituting the main body member 110 is formed by a phosphor containing a fluorescent dye that emits fluorescence in a prescribed wavelength range via irradiation with excitation light. The medical marker 100 may further comprise a washer member 120 which is crimped to the main body member 110by having a through-hole 121 formed therein, through which the protrusion 111 passes.

Description

[Technical Field]

[0001] The present invention relates to a medical marker that can be inserted into a hollow organ using, for example, an endoscope and used as a marker whose position can be visually recognized from outside the hollow organ. [Background Art]

[0002] In general, diseases such as cancer in the digestive tract including the esophagus, stomach, large intestine, etc., originate and progress mainly from the mucous membrane of the digestive tract. Similarly, lung cancer mainly originates from the tracheal mucosa, while bladder cancer mainly originates from the bladder mucosa and progresses. Therefore, to confirm the diagnosis of diseases of hollow organs such as the digestive tract, trachea, and bladder, it is essential to insert an endoscope into the hollow organ to observe the mucous membrane and biopsy the affected tissue. Based on the definitive diagnosis, the affected tissue is surgically resected as necessary.

[0003] However, in surgical resection, since the surgeon approaches from outside the hollow organ, the affected part inside the hollow organ cannot be directly visually recognized. That is, during thoracotomy, laparotomy, or laparoscopic surgery, when the digestive tract, lung, or bladder is observed with the naked eye or a laparoscope, what is visible is not the mucous membrane, but the serosal surface of the digestive tract, the serosal surface of the trachea, and the peritoneal surface of the bladder. Therefore, marking from inside the hollow organ is required so that the resection area can be determined even when observed from outside the hollow organ.

[0004] As a marker for performing such marking, for example, the medical marker described in Patent Document 1 below is known. Patent Document 1 discloses a clip-shaped medical marker comprising: a pair of arm plates that open into a substantially V shape by elasticity; claw portions formed at respective distal ends of the arm plates; and a tightening ring that is attached to the arm plates so as to be movable along the longitudinal direction of the pair of arm plates, and closes the pair of arm plates by moving in the direction of the claw portions, wherein on the outer surface of at least one of the claw portions, a fluorescent member containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light, and a reflective material that reflects at least one of the excitation light and the fluorescence are provided. [Prior art documents] [Patent Documents]

[0005] [Patent Document 1] Japanese Patent Publication No. 2021-69801 [Overview of the project] [Problems that the invention aims to solve]

[0006] The medical marker described in Patent Document 1 is useful because its clip shape makes it easy to attach to the inner wall of a tubular organ, and the fluorescent material and reflective material are positioned where they penetrate the inner wall of the tubular organ, allowing the fluorescence to be visible from the outside of the tubular organ, thus making it easy to identify the attachment location. However, it has the drawback that the gripping force of the clip is not necessarily strong.

[0007] Medical fluorescent markers need to be attached near the affected area within a tubular organ before surgery to allow for identification of the location of the affected area, and remain in place until the surgery. In this regard, the medical marker described in Patent Document 1 has the problem that the gripping force of the clip is not necessarily strong, so the period during which it can be left in the body is not necessarily long (for example, about 3 days), and there is a demand in the medical field for a medical marker that can be left in the body for a longer period and more reliably.

[0008] This invention has been made in view of the above problems, and aims to provide a medical marker that has excellent mounting stability, improved retention period, and excellent visibility from the outside of a tubular organ. [Means for solving the problem]

[0009] To achieve the above objective, the medical marker according to the present invention is a medical marker that is implanted in a tubular organ in the body, The device is constructed with a main body member having a projection configured to plastically deform at the tip due to a force applied axially from the tip side, and a flange formed continuously with the base periphery of the projection. The present invention is characterized in that at least a part or all of the protrusions and flanges constituting the main body member are made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.

[0010] According to the above configuration, at least one or more parts or all of the projections and flanges that constitute the main body of the medical marker are made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light. This allows the medical marker to be placed on the inner wall of a tubular organ with the projections penetrating the inner wall of the tubular organ, providing a medical marker with excellent attachment stability to the inner wall of the tubular organ and an improved period of placement. Furthermore, since the phosphor is positioned near the inner wall of the tubular organ, the location of the medical marker can be identified by visually observing the fluorescence emitted by the phosphor, providing a medical marker with excellent visibility from the outside of the tubular organ.

[0011] In the medical marker according to the present invention, the projection may be cylindrical or conical in shape, with the tip formed to be sharp.

[0012] With the above configuration, the tip of the projection can puncture the inner wall of a tubular organ, thereby improving the ability to penetrate the inner wall of a tubular organ.

[0013] The medical marker according to the present invention, in the above configuration, includes a washer member having a through hole through which the projection passes and which is crimped to the main body member. The force applied axially from the tip side may cause the tip of the protrusion to plastically deform into a shape that prevents it from passing through the through hole.

[0014] According to the above configuration, the tip of the projection is plastically deformed by a force applied axially from the tip side to a shape that prevents it from passing through the through hole of the washer member, thereby engaging the main body member and the washer member and further improving mounting stability.

[0015] In the above configuration, the medical marker according to the present invention may be composed of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range upon irradiation with excitation light, in which case at least a part or all of the washer member may be composed of a phosphor.

[0016] The above configuration makes it possible to further improve the visibility of the fluorescence emitted by the phosphor. [Brief explanation of the drawing]

[0017] [Figure 1A] This is a perspective view showing the configuration of the medical marker in this embodiment, viewed from one direction. [Figure 1B] This is a perspective view showing the configuration of the medical marker in this embodiment, viewed from the opposite direction to the one shown. [Figure 2A] This diagram illustrates the implantation state of the medical marker in this embodiment, and shows the internal tissue to which the medical marker is attached. [Figure 2B] This diagram illustrates the implantation state of the medical marker in this embodiment, showing the state in which the main body component of the medical marker has penetrated internal tissue. [Figure 2C] This diagram illustrates the implantation state of the medical marker in this embodiment, showing the medical marker attached to body tissue. [Figure 3] This figure shows the overall structure of an endoscopic forceps-type treatment instrument for implanting a medical marker in the body according to an embodiment of the present invention. [Figure 4] This is a plan view of the vicinity of the forceps portion of an endoscopic forceps-type treatment instrument for implanting a medical marker in the body, according to an embodiment of the present invention. [Figure 5]It is a partial cross-sectional view of the vicinity of the forceps portion of a forceps-type endoscopic treatment instrument for indwelling a medical marker in a body according to an embodiment of the present invention, showing a state where a pair of arm members are opened. [Figure 6] It is a partial cross-sectional view of the vicinity of the forceps portion of a forceps-type endoscopic treatment instrument for indwelling a medical marker in a body according to an embodiment of the present invention, showing a state where a pair of arm members are closed. [Figure 7] It is a diagram for explaining a procedure of indwelling a medical marker in a luminal organ according to an embodiment of the present invention. [Figure 8] It is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the first step of the procedure of indwelling a medical marker in a luminal organ. [Figure 9] It is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the second step of the procedure of indwelling a medical marker in a luminal organ. [Figure 10] It is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the third step of the procedure of indwelling a medical marker in a luminal organ. [Figure 11] It is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the fourth step of the procedure of indwelling a medical marker in a luminal organ. [Figure 12] It is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the fifth step of the procedure of indwelling a medical marker in a luminal organ. [Figure 13] It is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the sixth step of the procedure of indwelling a medical marker in a luminal organ. [Figure 14] It is a diagram showing a state where a plurality of medical markers are indwelled in a luminal organ according to an embodiment of the present invention. Mode for Carrying Out the Invention

[0018] Embodiments of the present invention will be described in detail below with reference to the drawings. In this specification, the patient's internal side is considered the distal side, and the operator's proximal side is considered the proximal side, with the operator implanting the medical marker according to the present invention in the patient's body as the reference point. The drawings referenced in this specification are not necessarily to an accurate scale with respect to actual dimensions, and some parts have been exaggerated or simplified in order to schematically illustrate the configuration according to the present invention.

[0019] First, the configuration of the medical marker 100 in this embodiment will be described with reference to Figures 1A, 1B, 2A, 2B, and 2C. Figure 1A is a perspective view showing the configuration of the medical marker 100 in this embodiment, viewed from one direction. Figure 1B is a perspective view showing the configuration of the medical marker 100 in this embodiment, viewed from the opposite direction. Figure 2A is a diagram illustrating the implantation state of the medical marker 100 in this embodiment, showing the internal tissue S to which the medical marker 100 is attached. Figure 2B is a diagram illustrating the implantation state of the medical marker 100 in this embodiment, showing the state in which the main body member 110 of the medical marker 100 has penetrated the internal tissue S. Figure 2C is a diagram illustrating the implantation state of the medical marker 100 in this embodiment, showing the state in which the medical marker 100 has been attached to the internal tissue S.

[0020] As shown in Figures 1A and 1B, the medical marker 100 in this embodiment is generally composed of a main body member 110 and a washer member 120. The main body member 110 is formed in the shape of a crimp nut, and the washer member 120 is formed in the shape of a washer (eyelet). The medical marker 100 in this embodiment is formed in a crimped shape as a whole, so that the main body member 110 and the washer member 120 can be crimped together.

[0021] The main body member 110 is generally configured to include a projection 111 and a flange 112.

[0022] The projection 111 extends in its axial direction, which is the longitudinal direction, and is formed in a columnar or pyramidal shape. The shape of the projection 111 is not particularly limited; for example, it can be formed in a cylindrical or conical shape, but it may also be formed in a polygonal columnar or polygonal pyramidal shape, where the cross-section is polygonal.

[0023] The projection 111 is configured to pierce the internal tissue S, which is the inner wall of a tubular organ, and penetrate the internal tissue S. Preferably, the tip 111a of the projection 111 is formed in a sharp shape (needle-like), as shown in Figures 1A, 1B, 2A, 2B, and 2C, so that it can pierce the surface of the internal tissue S and enter the interior of the internal tissue S.

[0024] The tip portion 111a of the projection 111 is configured to plastically deform when a force is applied from the tip side along its axial direction. The shape of the tip retaining portion 111b after plastic deformation is not particularly limited, but it is preferable that it plastically deforms into a shape that cannot pass through the through hole 121 formed in the washer member 120.

[0025] A flange portion 112 is positioned at the base end of the projection 111. The flange portion 112 is formed continuously with the base end periphery of the projection 111 and is a member that extends along a plane substantially perpendicular to the axial direction of the projection 111. The shape of the extended surface of the flange portion 112 positioned at the base end of the projection 111 is not particularly limited, but for example, it can be substantially circular around the axis of the flange portion 112.

[0026] The size of the main body member 110 is not particularly limited, but its overall size is set to a size that allows it to be transported to the internal tissue S using an endoscope. The axial length of the projection 111 is not particularly limited, but it is set to a size smaller than the maximum separation distance when the pair of forceps pieces 31 and 32 of the endoscopic forceps-type treatment instrument 10, which will be described later, are spread apart, so that they can be grasped by the pair of forceps pieces 31 and 32. The dimensions of the spreading surface formed by the flange 112 (or diameter if the spreading surface is approximately circular) are not particularly limited, as long as they are set to be larger than the diameter of the projection 111.

[0027] The washer member 120 is a flat plate-shaped member. The shape of the washer member 120 is not particularly limited; in this embodiment, the washer member 120 of the medical marker 100 is formed in a disc shape, but it may also be formed in a polygon shape, for example.

[0028] A through-hole 121 is formed in the center of the washer member 120, penetrating both the front and back surfaces of the flat plate-shaped member. When the medical marker 100 is attached to the internal tissue S, the projection 111 of the main body member 110 is inserted through the through-hole 121 of the washer member 120. The size and shape of the through-hole 121 of the washer member 120 are not particularly limited, as long as they are formed so that the projection 111 of the main body member 110 can be inserted through it. In the washer member 120 of the medical marker 100 in this embodiment, the through-hole 121 of the washer member 120 is also substantially circular in shape to match the substantially circular cross-section of the projection 111 of the main body member 110.

[0029] As shown in Figures 2A, 2B, and 2C, the medical marker 100 in this embodiment can be attached to internal tissue S. For example, as shown in Figure 2A, the tip 111a of the projection 111 constituting the main body member 110 is inserted into the surface of the internal tissue S from the raised surface of the internal tissue S, and the projection 111a is advanced so that it returns to the outside from the surface of the internal tissue S, thereby creating a state in which the projection 111 has penetrated the internal tissue S.

[0030] In the state shown in Figure 2B, the tip 111a of the projection 111 is passed through the through hole 121 of the washer member 120 from its tip side, so that the tip 111a of the projection 111 is exposed through the through hole 121 of the washer member 120, as shown in Figure 2B.

[0031] Then, in the state shown in Figure 2B, by applying force axially from the tip side to the tip 111a of the projection 111 using an endoscopic forceps-type treatment instrument 10, etc., which will be described later, the tip 111a of the projection 111 is plastically deformed. As shown in Figure 2C, the tip 111a of the projection 111 is plastically deformed to spread in a direction substantially perpendicular to its axial direction, forming a tip retaining portion 111b. The tip retaining portion 111b formed by the plastic deformation has a shape that prevents it from passing through the through hole 121 formed in the washer member 120. As a result, the projection 111 of the main body member 110 penetrates the internal tissue S, and the main body member 110 and the washer member 120 engage with the internal tissue S in a sandwiched state, thereby allowing the medical marker 100 to be attached to the internal tissue S.

[0032] In Figure 2C, the tip portion 111b is plastically deformed such that the tip portion 111a of the projection 111 is crushed from the tip side and spreads laterally in a direction substantially perpendicular to the axial direction on the surface of the washer member 120, making it impossible to pass through the through hole 121. However, the tip portion 111b is not limited to this shape; for example, the tip portion 111a may be plastically deformed such that it bends significantly into a substantially L-shape, making it impossible to pass through the through hole 121, thereby forming the tip portion 111b.

[0033] The washer member 120 functions as a back-holding member that works in cooperation with the main body member 110 to sandwich the internal tissue S, and also functions as an engaging member that firmly engages with the tip retaining portion 111b. By arranging the washer member 120, it is possible to more reliably prevent the projection 111 of the main body member 110 that has penetrated the internal tissue S from falling out. However, it is not always necessary to provide the washer member 120, and to prevent the projection 111 of the main body member 110 that has penetrated the internal tissue S from falling out, for example, a tip retaining portion 111b may be formed in which the tip portion 111a of the projection 111 is larger than the shaft diameter of the projection 111 (the hole formed when the projection 111 penetrates the internal tissue S). In other words, the medical marker 100 may be attached to the internal tissue S by plastically deforming the tip retaining portion 111b so that the projection 111 of the main body member 110 that has penetrated the internal tissue S does not fall out, without providing the washer member 120.

[0034] Furthermore, the main body member 110 and the washer member 120 may be connected using a connecting member. One end of the connecting member is connected to the main body member 110, and the other end is connected to the washer member 120. This ensures that the main body member 110 and the washer member 120 are always located in close proximity and do not become separated. The connecting member may be formed integrally with the main body member 110 and the washer member 120, or it may be made of a wire such as suture thread, with one end of the wire being the connecting member attached to the main body member 110 and the other end attached to the washer member 120.

[0035] At least part or all of the projection 111 and flange 112 that constitute the main body member 110 of the medical marker 100 are made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light. Specifically, part or all of the projection 111 may be made of a phosphor. Alternatively, part or all of the flange 112 may be made of a phosphor. Alternatively, part or all of both the projection 111 and the flange 112 may be made of a phosphor.

[0036] As described later, the medical marker 100 can be attached to the inner wall of a tubular organ and implanted in the body, for example, using an endoscopic forceps-type treatment instrument 10, which will be described later. Since the medical marker 100 is composed of a phosphor, the phosphor can be placed on the inner wall of a tubular organ, and the fluorescence of the phosphor can be seen from the outside of the tubular organ.

[0037] As the fluorescent dye, one that emits fluorescence in the red or near-infrared wavelength range of 600 to 1400 nm is preferred. Light in this wavelength range has high penetration into human tissues such as skin, fat, and muscle, and can reach well to a depth of about 5 to 20 mm below the surface of living tissue.

[0038] As fluorescent dyes that emit fluorescence in the above wavelength range, water-soluble dyes such as riboflavin, thiamine, NADH (nicotinamide adenine dinucleotide), and indocyanine green (ICG), and oil-soluble dyes such as the azo-boron complex compound described in Japanese Patent Application Publication No. 2011-162445 can be used. Among these, dyes with high compatibility with polymer materials are preferred because they are stably retained in polymer materials without eluting in the body. In particular, the azo-boron complex compound described in Japanese Patent Application Publication No. 2011-162445 is preferred because it exhibits excellent fluorescence emission intensity and also has excellent compatibility with polymer materials such as polyurethane, as well as excellent light resistance and heat resistance.

[0039] A phosphor containing a fluorescent dye can be manufactured using a polymer material composition. For example, when the protrusion 111 and the flange 112 are manufactured integrally by injection molding or insert molding, the entire protrusion 111 and flange 112 can be made to contain the fluorescent dye by using a polymer material containing a fluorescent dye as the molten material. Similarly, the washer member 120 can also be manufactured by injection molding or insert molding using a polymer material containing a fluorescent dye as the molten material. Furthermore, part or all of the phosphor may be manufactured using a matrix made of inorganic materials such as glass or ceramics. For example, an inorganic phosphor obtained by dispersing fluorescent particles containing the above-mentioned fluorescent dye in a matrix made of inorganic materials may be used as the phosphor constituting the medical marker 100.

[0040] One method for incorporating a fluorescent dye into a polymer material is to knead the fluorescent dye into the polymer material using a twin-screw kneader. In this case, the outer surface of the fluorescent dye-containing component may be further coated with a transparent material that does not contain the fluorescent dye, taking into consideration the protection of the component and its effects on living organisms.

[0041] The preferred concentration of the fluorescent dye in a polymer material composition containing a fluorescent dye depends on the type of fluorescent dye and the polymer material used as a binder, but is generally preferred to be 0.001 to 0.1% by mass.

[0042] Polyurethane, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, polyamide, polyamide elastomer, and the like can be used as polymer materials containing fluorescent dyes.

[0043] A contrast agent such as barium sulfate may be added to the polymer material composition containing the fluorescent dye, if necessary. This makes it possible to track the medical marker 100 within the tubular organ by X-ray imaging, even if the medical marker 100 detaches from the inner wall of the tubular organ within the body.

[0044] The following describes examples of how to use the medical marker 100 mentioned above. In this embodiment, the medical marker 100 can be implanted in the body using, for example, the endoscopic forceps-type treatment instrument 10 shown in Figure 3.

[0045] Referring to Figure 3, the endoscopic forceps-type instrument 10 for implanting the medical marker 100 inside the body in this embodiment will be described. Figure 3 is a diagram showing the overall structure of the endoscopic forceps-type instrument 10 for implanting the medical marker inside the body in this embodiment. As shown in Figure 3, the endoscopic forceps-type instrument 10 is generally composed of a sheath part 1, an operating part 2, and a forceps part 3. The operating part 2 is provided at the proximal end of the sheath part 1, and the forceps part 3 is provided at the distal end of the sheath part 1.

[0046] The operating unit 2 comprises a base 21 and a slider 22 slidably mounted on the base 21. The forceps unit 3 comprises a pair of forceps pieces 31 and 32 that are openable and closable relative to each other. In the operating unit 2, the pair of forceps pieces 31 and 32 can be opened by sliding the slider 22 distally (downward in Figure 3) relative to the base 21, and conversely, the pair of forceps pieces 31 and 32 can be closed by sliding the slider 22 proximal (upward in Figure 3) relative to the base 21.

[0047] The sheath section 1 comprises a tubular outer sheath 11, a tubular inner sheath 12 (not shown in Figure 3, see Figures 4 to 6) inserted inside the outer sheath 11, and a drive wire 13 inserted inside the inner sheath 12.

[0048] The outer sheath 11 and inner sheath 12 are made of flexible hollow tubes. The resin material forming the outer sheath 11 and inner sheath 12 is not particularly limited, and for example, polyethylene, polypropylene, polyvinyl chloride, polyurethane, polyamide, polyester, polycarbonate, polyethersulfone, fluororesin, etc. can be used.

[0049] The drive wire 13 is inserted into the inner sheath 12, and the inner sheath 12 is inserted into the outer sheath 11. The drive wire 13 is capable of rotation and sliding (sliding movement in the direction along the axial direction) around its axis within the inner sheath 12.

[0050] The drive wire 13 is a flexible wire. A single wire made of metal such as stainless steel can be used as the drive wire 13. However, a wire rope or a wire tube may also be used as the drive wire 13. Here, a wire rope is a rope made of stranded wire formed by twisting multiple wires made of metal such as stainless steel in a spiral shape. A wire tube is a tube made of hollow stranded wire formed by twisting multiple wires made of metal such as stainless steel in a spiral shape so that it is hollow.

[0051] The drive wire 13 is a power transmission member that transmits sliding force for opening and closing a pair of forceps pieces 31 and 32, and rotational force for rotating the pair of forceps pieces 31 and 32 around the sheath axis for adjusting their position. The proximal end of the drive wire 13 is fixed to the slider 22 by a screw 24.

[0052] The operating unit 2, as shown in Figure 3, is generally composed of a base 21, a slider 22, and a tip cap 23. The base 21 has a base ring portion 21a and a guide portion 21b having a guide groove. The slider 22 has a pair of slider ring portions 22a and 22b and is mounted on the base 21 so as to be slidable back and forth (up and down in Figure 3) along the guide portion 21b. A tip cap 23 is attached to the distal end of the base 21. The materials of the base 21, slider 22, and tip cap 23 are not particularly limited, and for example, resin can be used.

[0053] The tip cap 23 has a roughly cylindrical space inside. The proximal end of the sheath portion 1, which includes the outer sheath 11, inner sheath 12, and drive wire 13, is inserted into the through-hole formed inside the tip cap 23.

[0054] The tip cap 23 has a roughly cylindrical space on the inside of its distal end. The proximal end of the sheath portion 1, which includes the outer sheath 11, inner sheath 12, and drive wire 13, is inserted into the through-hole formed on the distal end of the tip cap 23.

[0055] The operator can operate the operating unit 2 with one hand by, for example, inserting their thumb into the base ring portion 21a and their index and middle fingers into the slider ring portions 22a and 22b, respectively. In the operating unit 2, for example, by sliding the slider 22 back and forth (up and down in Figure 3) relative to the base 21, the drive wire 13 can be slid in the axial direction within the sheath portion 1, and by rotating the operating unit 2 relative to the sheath portion 1 (outer sheath 11), the drive wire 13 can be rotated around its axis within the sheath portion 1.

[0056] First, the forceps portion 3 provided at the distal end of the endoscopic forceps-type treatment instrument 10 will be described with reference to Figures 4 to 6. Figure 4 is a plan view of the vicinity of the forceps portion 3 of the endoscopic forceps-type treatment instrument 10 for implanting a medical marker in the body in this embodiment. Figure 5 is a partial cross-sectional view of the vicinity of the forceps portion 3 of the endoscopic forceps-type treatment instrument 10 for implanting a medical marker in the body in this embodiment, showing the pair of arm members in an open position. Figure 6 is a partial cross-sectional view of the vicinity of the forceps portion 3 of the endoscopic forceps-type treatment instrument 10 for implanting a medical marker in the body in this embodiment, showing the pair of arm members in a closed position. Note that in Figures 5 and 6, the arm portion 43 has been removed, and the outer sheath 11, inner sheath 12, and the sheath insertion portion 41 of the forceps support member 40 are depicted in cross-section.

[0057] As shown in Figures 4 to 6, the forceps section 3 is generally configured to include a forceps mechanism 30 containing a pair of forceps pieces 31 and 32, and a forceps support member 40.

[0058] The forceps support member 40 is generally configured to include a sheath insertion portion 41, a neck portion 42, and a pair of arm portions 43 and 44.

[0059] The sheath insertion portion 41 is located on the proximal end side of the forceps support member 40 and is made of a cylindrical member. The sheath insertion portion 41 is inserted into the distal end of the outer sheath 11, and the outer circumferential surface of the sheath insertion portion 41 is adhesively fixed to the inner circumferential surface of the outer sheath 11. In addition, the distal end of the inner sheath 12 is inserted into the sheath insertion portion 41, and the outer circumferential surface of the inner sheath 12 is adhesively fixed to the inner circumferential surface of the sheath insertion portion 41.

[0060] A neck portion 42 is provided at the distal end of the sheath insertion portion 41. The neck portion 42 is formed integrally with the sheath insertion portion 41. A through hole 42a for passing the connecting member 33 is formed in the center of the neck portion 42.

[0061] A pair of arm portions 43 and 44 are integrally formed with the neck portion 42 at its distal end. The pair of arm portions 43 and 44 are provided to protrude distally from the neck portion 42. Near the distal ends of the pair of arm portions 43 and 44, through holes (only the through hole 43a of the forceps piece 31 is shown) are formed for pivotally supporting a pair of forceps pieces 31 and 32.

[0062] The pair of arm portions 43 and 44 are spaced apart so as to face each other, and a forceps mechanism 30 including a pair of forceps pieces 31 and 32 is positioned between the pair of arm portions 43 and 44.

[0063] The forceps mechanism 30 is generally composed of a pair of forceps pieces 31, 32, a connecting member 33, and connecting members 51, 52.

[0064] The connecting member 33 is made of, for example, metal. The connecting member 33 is configured to have a cylindrical portion 34 on its proximal end into which the distal end of the drive wire 13 can be inserted, and a plate-shaped portion 35 integrally on its distal end.

[0065] The cylindrical portion 34 is slidably positioned within the through-hole 43a of the through-hole 42a and the lumen of the inner sheath 12. The distal end of the drive wire 13 is inserted into the cylindrical portion 34 and fixed by laser welding or the like. As a result, the connecting member 33 can move back and forth along the axial direction in accordance with the axial movement of the drive wire 13, and can also rotate in accordance with the rotation of the drive wire 13 around its axial direction.

[0066] The plate-shaped portion 35 is composed of a substantially plate-shaped member having a plate surface that extends distally along the central axis of the cylindrical portion 34. The plate-shaped portion 35 is integrally provided on the distal end side of the cylindrical portion 34. The plate-shaped portion 35 has connecting member insertion holes 35a and 35b formed therein, penetrating substantially perpendicular to its plate surface. The connecting member insertion holes 35a and 35b of the plate-shaped portion 35 are through holes for attaching connecting members 51 and 52, respectively. The proximal ends of the connecting members 51 and 52 are rotatably inserted through the connecting member insertion holes 35a and 35b formed in the plate-shaped portion 35.

[0067] As shown in Figures 4 to 6, the pair of forceps pieces 31 and 32 are arranged in a roughly X-shape so as to intersect each other, and are rotatably supported between the pair of arm portions 43 and 44 of the forceps support member 40 at their intersection. For example, the pair of forceps pieces 31 and 32 each have through holes (only the through hole 31a of forceps piece 31 is shown) formed in their middle portions. The through holes (through hole 31a) of the pair of forceps pieces 31 and 32 and the through holes (through hole 43a) formed near the distal ends of the pair of arm portions 43 and 44 are arranged to overlap in a direction perpendicular to the axial direction, and the pivot projection 55a of the spacer member 55, which is formed to fit these through holes, is fitted into them, allowing the pair of arm portions 43 and 44 to be rotatably supported on the forceps support member 40.

[0068] The distal ends of the pair of forceps pieces 31 and 32 are configured so that when the pair of forceps pieces 31 and 32 are closed, their opposing surfaces are in close contact with each other. The pair of forceps pieces 31 and 32 function as gripping parts, and by their close contact with each other, the medical marker 100 in this embodiment can be gripped and pressed by the pair of forceps pieces 31 and 32 and crimped. The maximum separation distance when the pair of forceps pieces 31 and 32 are spread apart is greater than the axial dimension of the projection 111 that constitutes the main body member 110 of the medical marker 100, and is set so that the projection 111 and flange 112 of the main body member 110 are gripped and narrow pressure is applied in the axial direction of the projection 111. The shape of the opposing surfaces of the pair of forceps pieces 31 and 32 is not particularly limited. In the illustrated configuration, as an example, a plurality of teeth 31c, 32c are formed in the direction (width direction) along the rotation axis of the pair of forceps pieces 31, 32, and tip protrusions 31d, 32d are formed at the most distal ends. For example, a bottomed hole into which the tip 111a of the projection 111 can be fitted, or a gripping engagement portion having a shape that matches the flange 112 of the main body member 110, may be provided on the opposing surfaces of the pair of forceps pieces 31, 32, so that the projection 111 and flange 112 of the main body member 110 can be stably gripped.

[0069] Furthermore, connecting member insertion holes 31b and 32b are formed on the proximal ends of the pair of forceps pieces 31 and 32, respectively. The distal ends of connecting members 51 and 52 are rotatably inserted through the connecting member insertion holes 31b and 32b formed in the pair of forceps pieces 31 and 32, respectively.

[0070] The connecting members 51 and 52 are each formed by appropriately bending (plastically deforming) a single wire (wire-like member) made of a flexible (elastic) metal.

[0071] The configuration of the connecting members 51 and 52 is not particularly limited, as long as they connect the plate-shaped portion 35 constituting the connecting member 33 to the pair of forceps pieces 31 and 32 so that when the connecting member 33 moves back and forth in accordance with the axial movement of the drive wire 13, the proximal ends of the pair of forceps pieces 31 and 32 move closer together or further apart in accordance with the movement, causing the pair of forceps pieces 31 and 32 to open and close.

[0072] As an example, the distal end of the connecting member 51 is rotatably inserted into the connecting member insertion hole 31b formed in the forceps piece 31 and is bent so as not to come out of the connecting member insertion hole 31b. The proximal end of the connecting member 51 is rotatably inserted into the connecting member insertion hole 35a formed in the plate-shaped portion 35 and is bent so as not to come out of the connecting member insertion hole 35a. The distal end of the connecting member 52 is rotatably inserted into the connecting member insertion hole 32b formed in the forceps piece 32 and is bent so as not to come out of the connecting member insertion hole 32b. The proximal end of the connecting member 52 is rotatably inserted into the connecting member insertion hole 35b formed in the plate-shaped portion 35 and is bent so as not to come out of the connecting member insertion hole 35b.

[0073] With this configuration, the connecting members 51 and 52 transmit the axial sliding force of the drive wire 13 to the pair of forceps pieces 31 and 32, enabling them to open and close the pair of forceps pieces 31 and 32. In addition, the connecting members 51 and 52 transmit the rotational force of the drive wire 13 around the axial direction to the pair of forceps pieces 31 and 32, enabling them to rotate the pair of forceps pieces 31 and 32 around the axial direction.

[0074] The diameter of the wire constituting the connecting members 51 and 52 is, for example, about 0.20 to 0.45 mm. In contrast, the diameter of the connecting member insertion holes 31b, 32b, 35a, and 35b is, for example, about 0.25 to 0.45 mm. In order to allow the connecting members 51 and 52 to rotate within the connecting member insertion holes 31b, 32b, 35a, and 35b, it is preferable to make the diameter of the wire smaller than the diameter of the connecting member insertion holes 31b, 32b, 35a, and 35b by, for example, 0 to 0.10 mm.

[0075] Furthermore, as shown in Figures 5 and 6, a spacer member 55 is provided between the pair of forceps pieces 31 and 32. On both sides of the spacer member 55 are cylindrical or columnar axial support projections 55a that project toward the pair of forceps pieces 31 and 32 and the pair of arm portions 43 and 44. As described above, the axial support projections 55a of the spacer member 55 are formed to fit through holes (through holes 31a) in the pair of forceps pieces 31 and 32 and through holes (through holes 43a) in the pair of arm portions 43 and 44. By fitting the axial support projections 55a into these through holes, the pair of arm portions 43 and 44 are rotatably supported by the forceps support member 40.

[0076] Furthermore, the spacer member 55 may be provided with, for example, an engaging projection 55b that limits the range of opening and closing angles of the pair of forceps pieces 31 and 32, or a guide groove (not shown) that guides the opening and closing trajectory of the pair of forceps pieces 31 and 32. Alternatively, a substantially cylindrical kingpin 56 may be inserted through the lumen of the cylindrical pivot projection 55a. These measures enable the pair of forceps pieces 31 and 32 to be opened and closed stably.

[0077] The procedure for implanting the medical marker 100 described above will be explained below with reference to Figures 7 to 13. The following explanation will use the case of attaching the medical marker 100 to the inner wall of a tubular organ (such as the stomach wall) as an example.

[0078] Figure 7 shows the mucosa 5, which is the inner wall of a tubular organ, the serosal membrane 6, which is the outer wall, and a tumor 7 that has formed on the inner wall side of the tubular organ. Figures 8 to 13 are schematic enlarged views of the vicinity of region A in Figure 7, and illustrate the first to sixth steps of the procedure for implanting a medical marker 100 into a tubular organ. For clarity, the mucosa 5 and serosal membrane 6 of the tubular organ are shown in cross-section in Figures 7 to 13.

[0079] First, the endoscope 8 is inserted into the body, and its distal end is positioned near the lesion (tumor 7) in the tubular organ, which is the placement site for the medical marker 100. With the flange portion 112 constituting the main body member 110 of the medical marker 100 held between the pair of forceps pieces 31 and 32 of the endoscopic forceps-type treatment instrument 10, the distal end of the endoscopic forceps-type treatment instrument 10 is advanced through the channel of the endoscope 8, exposing the distal end of the endoscopic forceps-type treatment instrument 10 into the tubular organ, as shown in Figure 7.

[0080] In that state, as shown in Figure 8, the distal end of the endoscopic forceps-type instrument 10 is manipulated to pierce the tip 111a of the projection 111 that constitutes the main body member 110 of the medical marker 100 into the mucosa 5 of the inner wall of the tubular organ. Then, while pulling the distal end of the endoscopic forceps-type instrument 10 upwards towards the inner wall of the tubular organ, the projection 111 is advanced into the mucosa 5, and as shown in Figure 9, the projection 111 is inserted into the mucosa 5 so that the tip 111a of the projection 111 returns to the inside of the tubular organ. Here, the projection 111 is inserted into the mucosa 5, but the tip 111a of the projection 111 may be inserted deeper so that the projection 111 also penetrates a part of the serosa 6.

[0081] Here, the endoscopic forceps-type treatment instrument 10 is temporarily removed from the body, and the washer member 120 of the medical marker 100 is held between the pair of forceps pieces 31 and 32 of the endoscopic forceps-type treatment instrument 10. Then, the distal end of the endoscopic forceps-type treatment instrument 10 is advanced again through the channel of the endoscope 8, and as shown in Figure 10, the distal end of the endoscopic forceps-type treatment instrument 10 is exposed into the tubular organ.

[0082] Furthermore, if the main body member 110 and the washer member 120 are connected by a connecting member, the washer member 120 is transported into the tubular organ together with the main body member 110. In this case, the state shown in Figure 10 can be achieved by grasping the washer member 120 connected to the main body member 110 with the pair of forceps pieces 31 and 32 without removing the distal end of the endoscopic forceps-type treatment instrument 10 from the body.

[0083] Next, the distal end of the endoscopic forceps-type treatment instrument 10 is manipulated to pass the through-hole 121 of the washer member 120 through the tip 111a of the projection 111 that constitutes the main body member 110, as shown in Figure 11. Then, the pair of forceps pieces 31 and 32 are spread apart and closed together, as shown in Figure 12, while sandwiching the tip 111a of the projection 111 that constitutes the main body member 110 and the flange 112 that also constitutes the main body member 110. At this time, the gripping surface of the forceps piece (forceps piece 31 in Figure 11) that abuts the tip 111a of the projection 111 is positioned to be approximately perpendicular to the axial direction of the projection 111, and the pair of forceps pieces 31 and 32 are closed together while positioning them so that force is applied to the projection 111 from its tip side in the axial direction. This allows a force to be applied in the axial direction of the projection 111, causing the tip portion 111a of the projection 111 to undergo plastic deformation.

[0084] When the pair of forceps pieces 31 and 32 are fully closed, the tip portion 111a of the projection 111 plastically deforms to spread in a direction substantially perpendicular to its axial direction, forming a tip retaining portion 111b on the projection 111, as shown in Figure 13. This crimps the main body member 110 and the washer member 120, and the medical marker 100 is attached to the inner wall of the tubular organ.

[0085] When multiple medical markers 100 are to be placed near tumor 7, the endoscopic forceps-type instrument 10 is removed from the body, and then the distal end of the endoscopic forceps-type instrument 10, with the main body member 110 of a new medical marker 100 held between a pair of forceps pieces 31 and 32, is inserted into the body, and the above-described process is repeated. This allows multiple medical markers 100 to be attached to the inner wall of a tubular organ located near tumor 7, as shown in Figure 14. Once the desired number of medical markers 100 have been placed, the procedure for placing the medical markers 100 is complete.

[0086] Furthermore, when the projection 111 of the main body member 110 penetrates the internal tissue S, the washer member 120 may be omitted, and the tip portion 111a of the projection 111 may be plastically deformed to form the tip retaining portion 111b. In this case, for example, by forming a tip retaining portion 111b that is larger than the axial diameter of the projection 111 (the perforation hole formed when the projection 111 penetrates the mucosa 5), ​​the projection 111 of the main body member 110 can be prevented from falling out of the mucosa 5, and the medical marker 100 can be placed.

[0087] As described above, the medical marker 100 implanted in the body is composed of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light, at least part or all of the protrusions 111 and flanges 112 that make up the main body member 110 of the medical marker 100. The medical marker 100 is implanted in the body attached to the internal tissue that is the inner wall of a tubular organ, and the fluorescence of the phosphor constituting the medical marker 100 can be visually observed from outside the tubular organ. For example, before surgery that approaches from outside the tubular organ, one or more medical markers 100 can be implanted near the lesion (tumor 7) as described above, and during surgery, excitation light is irradiated from outside the tubular organ, and the fluorescence emitted by the components constituting the medical marker 100 can be visually observed using a camera or the like according to the wavelength of the fluorescence, thereby the location of the medical marker 100 can be identified, and the location of the lesion (tumor 7) can be identified from outside the tubular organ.

[0088] Furthermore, at least part or all of the washer member 120 constituting the medical marker 100 may be made of a phosphor containing a fluorescent dye. This allows for improved visibility of the fluorescence from the outside of the tubular organ due to the fluorescence emitted by the washer member 120, and also improves mounting stability by engaging the main body member 110 with the washer member 120.

[0089] The following describes the action of the medical marker 100 in the embodiment described above.

[0090] The medical marker 100 in the above-described embodiment is configured to have a main body member 110 having a projection 111 configured to plastically deform when a force is applied axially from the tip side to the tip portion 111a, and a flange portion 112 formed continuously with respect to the base end periphery of the projection 111. At least a part or all of the projection 111 and flange portion 112 constituting the main body member 110 is made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.

[0091] According to the above configuration, at least one or more parts or all of the protrusions 111 and flanges 112 that constitute the main body member 110 of the medical marker 100 are made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light. This allows the medical marker 100 to be placed on the inner wall of a tubular organ with the protrusions 111 penetrating the inner wall of the tubular organ, providing a medical marker 100 with excellent attachment stability to the inner wall of the tubular organ and an improved period of placement. Furthermore, since the phosphor is positioned near the inner wall of the tubular organ, the position of the medical marker 100 can be identified by visually observing the fluorescence emitted by the phosphor, providing a medical marker 100 with excellent visibility from the outside of the tubular organ.

[0092] In the medical marker 100 of the above-described embodiment, the projection 111 may be cylindrical or conical in shape, with the tip 111a formed into a sharp shape. This allows the tip 111a of the projection 111 to puncture the inner wall of a tubular organ, thereby improving the ability to penetrate into the inner wall of the tubular organ.

[0093] The medical marker 100 in the above-described embodiment may include a washer member 120 having a through-hole 121 through which the projection 111 passes and which is crimped onto the main body member 110. This allows the tip portion 111a of the projection 111 to plastically deform into a shape that cannot pass through the through-hole 121 of the washer member 120 due to a force applied axially from the tip side, thereby engaging the main body member 110 and the washer member 120 and further improving mounting stability. Furthermore, at least a part or all of the washer member 120 may be made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light. This further improves the visibility of the fluorescence.

[0094] The embodiments described above are provided to facilitate understanding of the present invention and are not intended to limit it. Accordingly, each element disclosed in the embodiments described above is intended to include all design modifications and equivalents that fall within the technical scope of the present invention. [Explanation of symbols]

[0095] 1. Sheath section 2 Control section 3. Forceps section 10 Endoscopic forceps-type treatment instruments 11 Outer Sheath 12 Inner sheath 13 Drive wire 21 Base 21a Base ring part 21b Guide section 22 Sliders 22a, 22b Slider ring section 23 Tip cap 24 screws 30 Forceps mechanism 31, 32 Forceps piece 31a, 42a, 43a through hole 31b, 32b, 35a, 35b Through holes for connecting members 31c, 32c mountain teeth 31d, 32d: teeth with convex tips 33 Connecting Member 34 Cylindrical section 35 Plate-shaped part 40 Forceps support member 41 Sheath insertion section 42 Neck 43, 44 Arm section 51, 52 Connecting members 55 Spacer member 55a Axle support projection 55b Engagement protrusion 56 Kingpin 100 Medical Markers 110 Main body components 111 Protrusion 111a Tip (tip of the protrusion) 111b Tip clasp 112 Guard section 120 Washer component 121 Through hole (through hole in washer member)

Claims

1. A medical marker that is implanted in a tubular organ within the body, The device is constructed with a main body member having a projection configured to plastically deform at the tip due to a force applied axially from the tip side, and a flange formed continuously with the base periphery of the projection. A medical marker characterized in that at least part or all of the protrusions and flanges constituting the main body member are made of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.

2. The medical marker according to claim 1, characterized in that the projection is cylindrical or conical in shape, with the tip formed in a sharp shape.

3. The system includes a washer member having a through hole formed for the projection to pass through, which is then crimped to the main body member. The medical marker according to claim 1 or 2, characterized in that the tip of the projection is plastically deformed into a shape that prevents it from passing through the through hole due to a force applied axially from the tip side.

4. The medical marker according to claim 3, characterized in that at least a part or all of the washer member is composed of a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.

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