medical markers

Abstract

To provide a medical marker which has excellent attachment stability to improve an anchorable period and has excellent visibility from the outside of a luminal organ.SOLUTION: A medical marker 100 comprises: a loop member 105 which has a loop portion 110 configured of endless wires 111 and 112; and a tube 130 externally fitted to the loop portion 110 of the loop member 105 in a slidable manner. A part or the whole of at least one of the loop member 105 and the tube 130 is constituted of a fluorescent body containing a fluorescent dye emitting fluorescence in a predetermined wavelength range by irradiation with excitation light.SELECTED DRAWING: Figure 1

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 technology]

[0002] In general, diseases such as cancer of the digestive tract, such as the esophagus, stomach, and large intestine, primarily develop and progress in the mucosa of the digestive tract. Similarly, lung cancer primarily develops in the tracheal mucosa, and bladder cancer primarily develops and progresses in the bladder mucosa. 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 mucosa and biopsy the affected tissue. Then, based on the confirmed diagnosis, the affected tissue is surgically resected as necessary.

[0003] However, during surgical resection, surgeons approach the hollow organ from the outside, making it impossible to directly visualize the affected area within the hollow organ. In other words, when observing the digestive tract, lungs, or bladder with the naked eye or laparoscope during thoracotomy, laparotomy, or laparoscopy, what is seen is not the mucosa, but the serous surface of the digestive tract, trachea, or bladder peritoneum. Therefore, it is necessary to mark the hollow organ from the inside so that the resection area can be determined even when observing the hollow organ from the outside.

[0004] A known example of a marker for such marking is the medical marker described in Patent Document 1 listed below. Patent Document 1 describes a clip-shaped medical marker that has a pair of arm plates that open in a generally V-shape due to elastic force, claws formed at each tip of the arm plates, and a fastening 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 it toward the claws, and in which 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 on the outer surface of at least one of the claws. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Patent Publication No. 2021-69801 Summary of the Invention [Problem to be solved by the invention]

[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 hollow organ, and fluorescent and reflective materials are placed at the position where it has penetrated into the inner wall of the hollow organ, making the fluorescence visible from outside the hollow organ, making it easy to identify the attachment position.However, there is an issue in that the gripping force of the clip is not necessarily strong.

[0007] The medical fluorescent marker must be attached near the affected area in the hollow organ before surgery so that the position of the affected area can be determined, and must remain in place until the time of surgery. In this regard, the medical marker described in Patent Document 1 has a problem in that the gripping force of the clip is not necessarily strong, and therefore the period during which it can be left in the body is not necessarily long (for example, about 3 days). In medical settings, there is a demand for a medical marker that can be left in the body for a longer period and more reliably.

[0008] The present invention has been made in consideration of the above-mentioned problems, and aims to provide a medical marker that has excellent attachment stability, extends the period of time it can be placed in place, and is highly visible from outside the tubular organ. [Means for solving the problem]

[0009] In order to achieve the above object, the medical marker according to the present invention is a medical marker to be placed in a luminal organ in the body, a loop member having a loop portion formed of an endless wire; a tube slidably fitted onto the loop portion of the loop member, The present invention is characterized in that at least one of the loop member and the tube is made of a fluorescent material 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 of the loop member having a loop portion constituting the medical marker and the tube is partially or entirely made of a fluorescent material 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 hollow organ while the loop portion is used to ligate a suture or the like sutured to the inner wall of the hollow organ, thereby providing a medical marker that is highly stable in attachment to the inner wall of the hollow organ and has an extended retention period. Furthermore, because the fluorescent material is placed near the inner wall of the hollow organ, the position of the medical marker can be identified by visually observing the fluorescence emitted by the fluorescent material, providing a medical marker that is highly visible from outside the hollow organ.

[0011] In the medical marker according to the present invention, in the above configuration, the loop member may have a locking portion configured to prevent the loop member from being pulled into the lumen of the tube.

[0012] According to the above configuration, when attempting to ligate a suture or the like sutured to the inner wall of a tubular organ with the loop portion in order to attach the medical marker inside the tubular organ, the loop member is prevented from falling out of the tube, thereby making it possible to provide a medical marker that is easy to place.

[0013] In the medical marker according to the present invention having the above-described configuration, a part or the whole of the engaging portion of the loop member may be made of the fluorescent material.

[0014] According to the above configuration, when the medical marker is attached to the inner wall of a tubular organ, an anchoring portion made of a fluorescent material is positioned near the inner wall of the tubular organ, thereby providing a medical marker with excellent visibility from outside the tubular organ. [Brief explanation of the drawings]

[0015] [Figure 1] FIG. 1 is a perspective view showing the configuration of a medical marker in an embodiment of the present invention, showing a state in which a tube is fitted onto the center of a loop portion. [Figure 2] FIG. 1 is a perspective view showing the configuration of a medical marker in an embodiment of the present invention, showing a state in which a tube is slid to one side of a loop portion. [Figure 3] FIG. 10 is a perspective view showing the configuration of a medical marker in an embodiment of the present invention, illustrating a state in which the connecting loop has been cut after the tube has been slid to one side of the loop portion. [Figure 4] FIG. 2 is a plan view corresponding to FIG. 1, illustrating ligation of a suture thread with a medical marker in this embodiment. [Figure 5] FIG. 3 is a plan view corresponding to FIG. 2, illustrating ligation of a suture thread with a medical marker in this embodiment. [Figure 6] FIG. 4 is a plan view corresponding to FIG. 3, illustrating ligation of a suture thread with a medical marker in this embodiment. [Figure 7] 1A and 1B are diagrams for explaining a procedure for placing a medical marker in a hollow organ according to an embodiment of the present invention. [Figure 8] FIG. 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the first step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. [Figure 9] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing a second step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. FIG. [Figure 10]8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing a third step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. FIG. [Figure 11] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing a fourth step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. FIG. [Figure 12] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing a fifth step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. FIG. [Figure 13] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing a sixth step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. FIG. [Figure 14] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing a seventh step of a procedure for placing a medical marker in a hollow organ using a suturing device in an embodiment of the present invention. FIG. [Figure 15] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing an eighth step of a procedure for placing a medical marker in a hollow organ using a suturing device in an embodiment of the present invention. FIG. [Figure 16] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the ninth step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. FIG. [Figure 17] 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing the tenth step of a procedure for placing a medical marker in a tubular organ using a suturing device in an embodiment of the present invention. FIG. [Figure 18] FIG. 8 is a schematic enlarged view of the vicinity of region A in FIG. 7, showing an eleventh step of a procedure for placing a medical marker in a hollow organ in an embodiment of the present invention using a suturing device. [Figure 19] FIG. 1 is a diagram showing a state in which a plurality of medical markers are placed in a hollow organ according to an embodiment of the present invention. [Figure 20]1 is a plan view showing a ligation device used when placing a medical marker in a tubular organ in an embodiment of the present invention. FIG. DETAILED DESCRIPTION OF THE INVENTION

[0016] Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings. In this specification, the inside of the patient's body is defined as the distal side, and the side of the operator's hand is defined as the proximal side, based on the operator who places the medical marker according to the present invention inside the patient's body. The drawings referred to in this specification are not necessarily to an accurate scale relative to the actual dimensions, and some parts are exaggerated or simplified to schematically illustrate the configuration according to the present invention.

[0017] (Medical marker) First, the configuration of the medical marker 100 of this embodiment will be described with reference to Figures 1 to 6. Figures 1 to 3 are perspective views showing the configuration of the medical marker 100 of this embodiment, with Figure 1 showing a state in which the tube 130 is fitted over the center of the loop portion 110, Figure 2 showing a state after the tube 130 has been slid to one side of the loop portion 110, and Figure 3 showing a state in which the connecting loop 122 of the loop portion 110 has been cut after the tube 130 has been slid to one side of the loop portion 110. Figures 4 to 6 are plan views corresponding to Figures 1 to 3, respectively, and are figures for explaining the ligation of the suture 4 with the medical marker 100 of this embodiment. Figures 4 to 6 depict the tube 130 with a two-dot chain line and show the state in which the suture 4 has been drawn into its lumen.

[0018] As shown in FIGS. 1 to 6, the medical marker 100 in this embodiment is configured to include a loop member 105 and a tube .

[0019] The loop member 105 has a loop portion 110 made of an endless wire, a locking portion 151 configured to prevent it from being pulled into the inner cavity of the tube 130, and a connecting portion 152 connecting the loop portion 110 and the locking portion 151.

[0020] The loop portion 110 is mainly composed of two flexible wires 111, 112 extending in a longitudinal direction while facing each other. The two wires 111, 112 are arranged symmetrically along the longitudinal direction, with distal curved portions 111a, 112a located on the distal end side (left side in Figs. 1 to 6) and proximal curved portions 111b, 112b located on the proximal end side (right side in Figs. 1 to 6) each being pre-shaped into an outwardly curved shape. The wire diameter of the wires 111, 112 is not particularly limited, but may be, for example, 0.3 to 0.8 mm.

[0021] The distal ends 111c, 112c of the two wires 111, 112 are respectively connected to the proximal end surface 152a of the connecting portion 152. The proximal ends 111d, 112d of the two wires 111, 112 are connected to each other at the proximal end connecting portion 113. This makes the loop portion 110 endless. Note that the distal ends 111c, 112c of the two wires 111, 112 may also be connected to each other in the same manner as the proximal ends, and the connecting portion may be connected to the proximal end surface 152a of the connecting portion 152.

[0022] The tube 130 is a cylindrical member with an open distal end surface 130a and a proximal end surface 130b. The tube 130 preferably has elasticity so that its inner cavity can expand in diameter. Two wires 111, 112 that constitute the endless loop portion 110 of the loop member 105 are inserted into the inner cavity of the tube 130, and the tube 130 is slidably fitted around the loop portion 110. For example, the two wires 111, 112 are brought close to each other, and the proximal end connecting portion 113 is press-fitted into the inner cavity of the tube 130, thereby allowing the tube 130 to be slidably fitted around the loop portion 110.

[0023] The axial dimension of the tube 130 is not particularly limited, but may be, for example, 3 to 10 mm. The outer diameter of the tube 130 is not particularly limited, but may be, for example, 1 to 2 mm. The inner diameter of the tube 130 is not particularly limited, but may be, for example, 0.1 to 0.8 mm.

[0024] The proximal curved portions 111b, 112b of the two wires 111, 112 are configured to maintain a distance greater than the inner diameter of the tube 130 even when the two wires 111, 112 are closest to each other. This prevents the tube 130, which is disposed near the center of the loop portion 110, from easily sliding toward the proximal end beyond the proximal curved portions 111b, 112b. In other words, the proximal curved portions 111b, 112b have the function of restricting the sliding of the tube 130, which is fitted around the loop portion 110, toward the proximal end. The tube 130 cannot easily slide toward the proximal end beyond the vicinity of the proximal curved portions 111b, 112b, and is prevented from slipping off from the proximal end of the loop portion 110.

[0025] The distal curved portions 111a, 112a of the two wires 111, 112 are formed in positions that will be located proximal to the proximal end surface 130b of the tube 130 when the tube 130 slides distally and holds the suture 4 in its lumen, as will be described later. The distal curved portions 111a, 112a are formed so as to bulge outward, and have the function of assisting in fixing the tube 130 by the two wires 111, 112 coming into contact with the inner circumferential surface of the tube 130 when it holds the suture 4.

[0026] A locking portion 151 and a connecting portion 152 are provided on the distal end side of the loop member 105 that constitutes the medical marker 100. The locking portion 151 is configured to prevent the loop member 105 from being pulled into the lumen of the tube 130, so as to prevent the loop member 105 from slipping out from the proximal end side of the tube 130, and serves to lock the loop member 105 onto the end face on the distal end side of the tube 130.

[0027] The locking portion 151 is located closer to the distal end than the connecting portion 152 and is formed in a generally circular plate shape. The outer diameter of the locking portion 151 is larger than the inner diameter of the tube 130 and is set to a dimension that prevents the tube 130 from fitting therein. As a result, when the tube 130 slides toward the distal end, the distal end surface 130a of the tube 130 abuts against the proximal end surface 151a of the locking portion 151, preventing the tube 130 from sliding beyond the locking portion 151. That is, the locking portion 151 has the function of restricting the tube 130 fitted over the loop portion 110 from sliding toward the distal end. The tube 130 cannot slide toward the distal end beyond the locking portion 151, preventing the loop member 105 from slipping off from the proximal end of the tube. The shape of the locking portion 151 is not limited to a generally circular plate shape; it is sufficient if part or all of the locking portion 151 has a dimension larger than the inner diameter of the tube 130 so as to restrict the tube 130 from sliding toward the distal end.

[0028] The connecting portion 152 is formed in a substantially cylindrical shape. The outer diameter of the connecting portion 152 is set to a dimension equal to or slightly larger than the inner diameter of the tube 130 so that the connecting portion 152 can be inserted or press-fitted into the inner cavity of the tube 130. As described above, the distal ends 111c and 112c of the two wires 111 and 112 are respectively connected to the base end surface 152a of the connecting portion 152, and the tube 130 fitted over the loop portion 110 can slide toward the distal end and fit into the connecting portion 152 so as to draw the connecting portion 152 into the inner cavity of the tube 130.

[0029] The outer diameter of the locking portion 151 can be set, for example, in the range of 0.8 to 2.0 mm. The axial length (dimension) of the connecting portion 152 can be set, for example, in the range of 1 to 5 mm. The outer diameter of the connecting portion 152 can be set, for example, in the range of 0.3 to 1.6 mm.

[0030] When the tube 130 fitted over the loop portion 110 of the loop member 105 is positioned near the center of the loop portion 110, the loop portion 110 forms loops on both axial end sides of the tube 130. In this specification, the distal loop formed on the distal side of the distal end surface 130a of the tube 130 and used to ligate a suture 4 or the like for the purpose of attaching the medical marker 100 to the inner wall of a luminal organ and retaining it in the body is referred to as a ligation loop 121, and the proximal loop formed on the proximal side of the proximal end surface 130b of the tube 130 and connected to a ligation device 2, which will be described later, when ligating the suture 4 or the like is referred to as a connecting loop 122.

[0031] When ligating a suture 4 using the medical marker 100, first, both ends of the suture 4 are bundled and passed through the ligation loop 121 as shown in Fig. 4, and then the tube 130 is slid toward the distal end using the ligation device 2 described below so that the ligation loop 121 is drawn into the tube 130. As a result, the two wires 111, 112 and the connection portion 152 that form the ligation loop 121 are pressed into the tube 130 together with the suture 4 and drawn into the lumen of the tube 130 as shown in Fig. 5.

[0032] When tube 130 is slid to a position where distal end surface 130a of tube 130 abuts against proximal end surface 151a of locking portion 151, the inner diameter of tube 130 expands due to pressure from connecting portion 152 of loop member 105 and suture 4. Then, suture 4 press-fitted into tube 130 is sandwiched between the inner circumferential surface of tube 130 and the outer circumferential surface of connecting portion 152 by the restoring force (fastening force) of tube 130, and is firmly held within tube 130.

[0033] Furthermore, the distal curved portions 111a, 112a of the two wires 111, 112 are disposed on the proximal side of the proximal end surface 130b of the tube 130, which holds the suture 4 as described above. Because the distal curved portions 111a, 112a are pre-shaped to be curved outward, the two wires 111, 112 press against the inner circumferential surface of the tube 130, making it difficult for the tube 130 to slip toward the proximal end, and the state in which the suture 4 is fastened by the tube 130 is maintained.

[0034] After the suture 4 has been ligated with the medical marker 100 as described above, the two wires 111, 112 (the wires 111, 112 forming the connecting loop 122) extending proximally from the proximal end surface 130b of the tube 130 may be cut off, if necessary, as shown in Figures 3 and 6. Even when the proximal ends of the two wires 111, 112 are cut off, the suture 4 is firmly held within the tube 130 by the portion of the loop member 105 remaining at the distal end.

[0035] At least one of the loop member 105 and the tube 130 constituting the medical marker 100 is made of a fluorescent material containing a fluorescent dye, either in part or in whole. Specifically, the loop member 105 may be made of a fluorescent material in part or in whole. Alternatively, the tube 130 may be made of a fluorescent material in part or in whole.

[0036] Furthermore, both the loop member 105 and the tube 130 constituting the medical marker 100 may be made of a fluorescent material containing a fluorescent dye in part or in whole. Specifically, the loop member 105 and the tube 130 may be made of a fluorescent material in part or in whole.

[0037] As will be described later, the medical marker 100 can be attached to the inner wall of a hollow organ and placed inside the body by, for example, ligating a suture 4 with the medical marker 100. By making the medical marker 100 from a fluorescent substance, the fluorescent substance can be placed on the inner wall of the hollow organ, and the fluorescence of the fluorescent substance can be visually recognized from outside the hollow organ.

[0038] Furthermore, when the two wires 111, 112 extending on the base end side of the medical marker 100 are cut off after the medical marker 100 has been attached to the inner wall of a hollow organ, the distal end portion of the loop member 105 shown in Figures 3 and 6 will be left inside the body. Taking this into consideration, part or all of the distal end portion of the loop member 105 that will be left inside the body (for example, the locking portion 151) may be made of a fluorescent material.

[0039] The fluorescent dye preferably emits fluorescence in the red or near-infrared wavelength range of 600 to 1400 nm. Light in this wavelength range is highly permeable to human tissues such as skin, fat, and muscle, and can easily penetrate up to about 5 to 20 mm below the surface of living tissue.

[0040] Fluorescent dyes that emit fluorescence in the above-mentioned wavelength ranges can include water-soluble dyes such as riboflavin, thiamine, NADH (nicotinamide adenine dinucleotide), and indocyanine green (ICG), as well as oil-soluble dyes such as the azo-boron complex compound described in JP 2011-162445 A. Among these, dyes that are highly compatible with polymeric materials are preferred because they are stably retained in the polymeric material without eluting in the body, and the azo-boron complex compound described in JP 2011-162445 A is particularly preferred because it has excellent fluorescent emission intensity, compatibility with polymeric materials such as polyurethane, and excellent light resistance and heat resistance.

[0041] The fluorescent material containing the fluorescent dye can be produced using a polymer material composition. For example, when the entire loop member 105 is produced integrally by injection molding, insert molding, or the like, the entire loop member 105 can be made of the fluorescent material by using a polymer material containing the fluorescent dye as the molten material. The tube 130 can also be produced entirely of the fluorescent material by extrusion molding or the like using a polymer material containing the fluorescent dye as the molten material. The fluorescent material can also be produced entirely or partially using a matrix made of an inorganic material such as glass or ceramics. For example, an inorganic fluorescent material obtained by dispersing fluorescent particles containing the fluorescent dye in a matrix made of an inorganic material can be used as the fluorescent material constituting the medical marker 100.

[0042] A method for incorporating a fluorescent dye into a polymeric material can be, for example, a method in which the fluorescent dye is kneaded into the polymeric material using a twin-screw kneader. In this case, in consideration of protecting the fluorescent dye-containing component and its effects on living organisms, the outer surface of the fluorescent dye-containing component may be further coated with a transparent material that does not contain the fluorescent dye.

[0043] The preferred concentration of the fluorescent dye in the polymer material composition containing the fluorescent dye depends on the type of fluorescent dye and the polymer material used as a binder, but is usually preferably 0.1 to 0.001% by mass.

[0044] As the polymer material containing the fluorescent dye, polyurethane, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, polyamide, polyamide elastomer, etc. can be used.

[0045] A contrast agent such as barium sulfate may be added to the polymer material composition containing the fluorescent dye, if necessary, which makes it possible to track the medical marker 100 inside the hollow organ by X-ray imaging, even if the medical marker 100 becomes detached from the inner wall of the hollow organ inside the body.

[0046] The following describes an example of how to use the above-mentioned medical marker 100. When attaching and placing the medical marker 100 on the inner wall of a hollow organ, for example, the ligation device 2 and suturing device 3 described below can be used.

[0047] (ligation device) As shown in FIG. 20, the ligation device 2 is generally configured to include a connecting hook 21, a sheath 22, a drive wire 23, a locking mechanism having a base-side locking member 25 and a sheath-side locking member 26, and an operating unit having a base portion 27 and a slider portion 28.

[0048] The sheath 22 is a flexible hollow tube configured to be insertable into a channel of an endoscope. A simple tube made of resin or the like may be used as the sheath 22, but in this embodiment, a coil tube is used. A flat wire coil tube formed by spirally winding a long flat plate made of a metal such as stainless steel may be used as the coil tube. However, a round wire coil tube or an internally flat coil tube may also be used. A wire tube may also be used as the sheath 22. The wire tube is a tube made of hollow stranded wires formed by spirally twisting multiple wires (cables) made of a metal such as stainless steel.

[0049] A substantially cylindrical tip member 24 is fixed integrally to the tip (distal end) of the coil tube of the sheath 22, and the distal end surface of the tip member 24 serves as an abutment portion that can abut against the tube 130 of the medical marker 100. However, from the standpoint of reducing costs and the number of parts, the tip member 24 does not have to be provided, and in this case, the distal end surface of the coil tube serves as the abutment portion that abuts against the tube 130 of the medical marker 100.

[0050] The drive wire 23 is made of a flexible wire, and in this embodiment, a wire rope is used. A wire rope is a rope made of strands formed by helically twisting multiple wires (cables) made of metal such as stainless steel. However, the drive wire 23 may also be made of a single wire.

[0051] A connecting hook 21 is attached integrally to the tip (distal end) of the drive wire 23. The connecting hook 21 is made of an elastic body having a pair of arms 21a arranged to open apart in a generally V-shape toward the tip, and claws 21b formed by bending the tips of the arms 21a inward. The base ends of the arms 21a are integrated with each other and are fixed integrally to the tip (distal end) of the drive wire 23 by welding or the like.

[0052] By sliding the drive wire 23 so as to push it toward the distal end relative to the sheath 22 (i.e., by sliding the sheath 22 toward the proximal end relative to the drive wire 23), the connecting hook 21 protrudes from the distal end of the sheath 22 and opens its legs in a generally V-shape due to its own elasticity. Conversely, by sliding the drive wire 23 so as to pull it toward the proximal end relative to the sheath 22 (i.e., by sliding the sheath 22 toward the distal end relative to the drive wire 23), the connecting hook 21 is accommodated inside the distal end of the sheath 22 and closes its legs.

[0053] By holding the drive wire 23 in a fixed position and operating the sheath 22 to push or pull in, the pair of arms 21a of the connecting hook 21 can be freely opened and closed (gripped or released) while keeping the position of the connecting hook 21 constant. The connecting hook 21 can be made of a metal such as stainless steel.

[0054] The base end (proximal end) of the sheath 22, through which the drive wire 23 is inserted, is connected and fixed to the distal end of the base portion 27 via a luer lock mechanism having a base side locking member 25 and a sheath side locking member 26.

[0055] A slider portion 28 is slidably attached to the base portion 27, and the proximal end of the drive wire 23 passes through the through holes of the sheath side locking member 26 and the base side locking member 25, reaches the slider portion 28, and is removably fixed to the slider portion 28 via a lock screw 29.

[0056] By sliding the slider portion 28 toward the distal end relative to the base portion 27, the connecting hook 21 provided at the distal end of the drive wire 23 is pushed out from the distal end of the sheath 22 and spreads out in a generally V-shape due to its own elasticity. Conversely, by sliding the slider portion 28 toward the proximal end relative to the base portion 27, the connecting hook 21 provided at the distal end of the drive wire 23 is recessed from the distal end of the sheath 22 and is housed inside the sheath 22.

[0057] (suture device) 8, the suturing device 3 includes a pair of front and rear arms 31, 32 and an arm actuator 33 that operates the pair of front and rear arms 31, 32. The suturing device 3 is fixed to the endoscope 1 for use by attaching the arm actuator 33 to the outside of the shaft of the endoscope 1 along the shaft. While checking the movement of the pair of front and rear arms 31, 32 using the camera of the endoscope 1, the suture thread 4 can be sewn into the inner wall of a hollow organ using the pair of front and rear arms 31, 32 to which the suture thread 4 has been previously attached.

[0058] The arm actuation unit 33 is a long member extending along the axial direction, and is made up of three tubes (or two tubes and a wire) that are flexible enough to bend in accordance with the bending of the shaft of the endoscope 1. That is, the arm actuation unit 33 is made up of a case tube 33a, a rear arm moving tube 33b, and a front arm moving tube 33c (or a front arm moving wire).

[0059] The case tube 33a is a hollow tubular member that is fixed to the shaft of the endoscope 1 by the endoscope attachment 1a. The case tube 33a is not particularly limited, but can be made of a material such as polyethylene or polyvinyl chloride.

[0060] The rear arm movement tube 33b is a hollow tube-shaped member inserted into the case tube 33a and is provided within the case tube 33a so as to be movable along its axial direction and rotatable about its axis. The rear arm 32 is connected to the tip of the rear arm movement tube 33b. The rear arm movement tube 33b is not particularly limited, but can be formed, for example, from a resin tube such as polyethylene or polyvinyl chloride, or a wire tube made of metal wire. In particular, since the rear arm 32 is oscillated by rotating the rear arm movement tube 33b, a tube that can oscillate the rear arm 32 by an amount equal to the rotation amount of the rear arm movement tube 33b when rotated at the hand side is preferable. For example, the above function can be achieved by forming the rear arm movement tube 33b into a wire tube using multiple metal wires whose axial directions are parallel to each other and arranged coaxially.

[0061] The front arm moving tube 33c is inserted into the rear arm moving tube 33b and is provided so that it can move along its axial direction and rotate around its axis within the rear arm moving tube 33b. The front arm 31 is connected to the tip of the front arm moving tube 33c. The front arm moving tube 33c is not particularly limited, but it is preferable to use a material that is highly rigid for approximately the distal 10 mm and softer near the tip but does not contract or expand in the forward / rearward direction. For example, the front arm moving tube 33c can be made of a highly rigid rod-shaped section made of metal or the like approximately 10 mm from the distal end, with the remaining section made of wire or the like. In particular, since the front arm 31 is swung by rotating the front arm moving tube 33c, it is preferable that when the front arm moving tube 33c is rotated near the proximal end, the rear arm 32 be swung by the same amount.

[0062] The base end of the front arm moving tube 33c and the base end of the rear arm moving tube 33b extend to the vicinity of the operating section that operates the shaft of the endoscope 1. Therefore, by operating the base end of each tube 33b, 33c, it is possible to control the movement of the tip of each tube 33b, 33c (advancement and retraction along the axial direction, rotation around the axis).

[0063] By moving the front arm moving tube 33c and the rear arm moving tube 33b simultaneously or either one of them along the axial direction, the pair of front and rear arms 31, 32 can be moved closer to or farther away from each other. Furthermore, by rotating the front arm moving tube 33c about its axis, the front arm 31 can be rotated about the axis of the front arm moving tube 33c, and by rotating the rear arm moving tube 33b about its axis, the rear arm 32 can be rotated about the axis of the rear arm moving tube 33b.

[0064] The outer diameter of the arm actuating unit 33 (i.e., the outer diameter of the case tube 33a) is not particularly limited as long as it allows the endoscope 1 to which the suturing device 3 of this embodiment is attached to be inserted into a hollow organ (or into an overtube). For example, the outer diameter of the arm actuating unit 33, which is the combined outer diameter of the arm actuating unit 33 and the shaft of the endoscope 1, is preferably about 11 to 13 mm, and more preferably about 11 to 12 mm.

[0065] The rear arm 32 includes a rectangular member 32a formed in a generally rectangular shape, and the tip of a rear arm moving tube 33b is connected to the rear arm 32. Hereinafter, the central axis of the rear arm moving tube 33b at the connection portion between the rear arm moving tube 33b and the rear arm 32 will be simply referred to as the central axis of the tip of the rear arm moving tube 33b. A through hole (not shown) that passes through from top to bottom is formed in the rear arm 32, and the central axis of the tip of the rear arm moving tube 33b is arranged so that it is approximately coaxial with the central axis of the through hole.

[0066] A needle-shaped member 34 is provided at the tip of the strip member 32a of the rear arm 32. This needle-shaped member 34 has a large diameter portion 34a, a medium diameter portion 34b, a small diameter portion 34c, and an arrowhead-shaped portion 34d. The outer diameter of the base end of the arrowhead-shaped portion 34d is larger than the outer diameter of the tip of the small diameter portion 34c, and is formed so as to form a step at the connection portion with the small diameter portion 34c.

[0067] The needle-shaped member 34 is attached to the strip member 32a of the rear arm 32 so that its tip faces the front arm 31 and its central axis is approximately parallel to the central axis of the tip of the rear arm moving tube 33b.

[0068] By rotating the rear arm moving tube 33b around its central axis, the needle-shaped member 34 can be rotated around the central axis of the tip of the rear arm moving tube 33b while maintaining the central axis of the needle-shaped member 34 parallel to the central axis of the tip of the rear arm moving tube 33b.

[0069] The needle-shaped member 34 may have any length and strength sufficient to pierce and penetrate the target, and to be able to move in the opposite direction from the penetrated state and be withdrawn from the target. There are no particular limitations on its length or shaft diameter. For example, the length of the needle-shaped member 34 is preferably about 7 to 20 mm, more preferably about 7 to 10 mm. The diameter of the large-diameter portion 34a of the needle-shaped member 34 is preferably about 1.5 to 3.0 mm, the diameter of the medium-diameter portion 34b is about 1.0 to 2.0 mm, the diameter of the small-diameter portion 34c is about 0.5 to 1 mm, and the maximum diameter of the arrowhead-shaped portion 34d is preferably about 0.6 to 1.5 mm. The material of the needle-shaped member 34 is not particularly limited, but metal is preferred to ensure sufficient strength.

[0070] The above-mentioned medical marker 100 is attached to the large diameter portion 34a of the needle-shaped member 34. The medical marker 100 is attached to the large diameter portion 34a of the needle-shaped member 34 by sliding the tube 130 toward the ligation loop 121 with the large diameter portion 34a of the needle-shaped member 34 passing through the ligation loop 121.

[0071] A bifurcated portion 31s formed in a generally U-shape (or may be V- or C-shaped) is provided at the tip of the front arm 31, and the suture 4 is attached so as to span across this bifurcated portion 31s. Annular engaging members 4a, 4b are attached to both ends of the suture 4. A through-hole (not shown) is formed at each tip of the bifurcated portion 31s of the front arm 31, penetrating from the front surface (lower surface in FIG. 8) to the rear surface (upper surface in FIG. 8), and a storage space (not shown) with which the engaging members 4a, 4b can engage is formed on the rear surface side of the through-hole. The diameter of the storage space is set to be slightly larger than that of the through-hole, and the diameter is set to be such that the engaging members 4a, 4b can be engaged with the inner wall of the through-hole, which penetrates from front to back, when the through-hole is positioned so that it is generally concentric with the through-hole of the bifurcated portion 31s.

[0072] The through-holes of the engaging members 4a, 4b are configured so that the arrowhead-shaped portion 34d of the needle-shaped member 34 can be inserted through them, but once the arrowhead-shaped portion 34d is completely inserted through the through-hole, the engaging members 4a, 4b will not fall out of the needle-shaped member 34. Specifically, the engaging members 4a, 4b are formed so that their inner diameter is smaller than the outer diameter of the arrowhead-shaped portion 34d of the needle-shaped member 34 but larger than the axial diameter of the tip of the small-diameter portion 34c of the needle-shaped member 34 (i.e., the portion connecting with the arrowhead-shaped portion 34d). A concave suture receiving portion (not shown) that opens to the front surface (the bottom surface in FIG. 8) is provided in the center of the bifurcated portion 31s, and the intermediate portion of the suture 4 arranged across the bifurcated portion 31s is received in this suture receiving portion.

[0073] 7 to 18, the placement of the medical marker 100 using the above-mentioned medical marker 100, ligation device 2, suturing device 3, suture thread 4, and endoscope 1 will be described below. In the following, the case of attaching the medical marker 100 to the inner wall of a hollow organ (such as the stomach wall) will be described as an example.

[0074] FIG. 7 shows the mucosa 5, which is the inner wall of a hollow organ, the serosa 6, which is the outer wall, and a tumor 7 occurring on the inner wall side of the hollow organ. Also, FIGS. 8 to 18 are schematic enlarged views of the vicinity of area A in FIG. 7, showing steps 1 to 11 of the procedure for placing a medical marker 100 inside a hollow organ. For clarity of illustration, the mucosa 5 and serosa 6 of the hollow organ are shown in cross section in FIGS. 8 to 18. Also, in FIGS. 8 to 18, the inner wall of the hollow organ is shown on the right side of the drawing.

[0075] First, as shown in Figure 7, a medical marker 100 is attached to the suturing device 3, and the shaft of the endoscope 1 to which the suturing device 3 is attached using an endoscope attachment tool 1a is inserted into the body, and the distal end of the endoscope 1 is positioned near a lesion (tumor 7) in a tubular organ, where the medical marker 100 will be placed.

[0076] 8, the rear arm moving tube 33b and the front arm moving tube 33c of the arm actuation unit 33 are operated to press the front arm 31 against the inner wall of the hollow organ, while positioning the protrusion P on the inner wall of the hollow organ at a position where it can be sandwiched between one of the bifurcated portions 31s of the front arm 31 and the needle-shaped member 34. As a result, the front arm 31 is positioned at a position where it can be sandwiched between one of the bifurcated portions 31s of the front arm 31 and the needle-shaped member 34. Note that, after artificially forming a protrusion P on the inner wall of the hollow organ by pulling the inner wall of the hollow organ inward using endoscopic forceps or the like inserted into the endoscope 1, the protrusion P may be positioned between the tip of the needle-shaped member 34 and the front arm 31.

[0077] From this state, when the rear arm moving tube 33b of the arm operating unit 33 is operated to bring the rear arm 32 closer to the front arm 31, the needle-like member 34 pierces the protruding portion P and penetrates from one surface of the protruding portion P to the other, and further, the arrowhead-shaped portion 34d of the needle-like member 34 penetrates and passes through the through-hole of the engaging member 4a housed (supported) in the housing space of one of the bifurcated portions 31s. As a result, the through-hole of the engaging member 4a reaches the small-diameter portion 34c of the needle-like member 34, and the engaging member 4a is engaged with the needle-like member 34.

[0078] Next, when the rear arm moving tube 33b of the arm operating unit 33 is operated to move the rear arm 32 away from the front arm 31, as shown in Figure 10, the needle-shaped member 34 engaged with the engaging member 4a moves backward through the hole (hereinafter referred to as the first perforation) formed when the needle-shaped member 34 was inserted into the protruding portion P and returns to one side of the protruding portion P. This causes a part of the suture thread 4 (the part on the engaging member 4a side) to pass through the first perforation formed in the protruding portion P.

[0079] Then, as shown in Figure 11, the front arm 31 and the rear arm 32 are positioned so that the other bifurcated portion 31s of the front arm 31 and the needle-shaped member 34 sandwich a position different from the first perforation formed in the protrusion P.

[0080] From this state, when the rear arm moving tube 33b of the arm operating unit 33 is operated to bring the rear arm 32 closer to the front arm 31, the needle-like member 34 pierces the protruding portion P and penetrates from one surface of the protruding portion P to the other surface, and further, the arrowhead-shaped portion 34d of the needle-like member 34 penetrates and passes through the through-hole of the engaging member 4b housed (supported) in the housing space of the other bifurcated portion 31s, as shown in Figure 12. As a result, the through-hole of the engaging member 4b reaches the small-diameter portion 34c of the needle-like member 34, and the engaging member 4b is engaged with the needle-like member 34.

[0081] Next, when the rear arm moving tube 33b of the arm operating unit 33 is operated to move the rear arm 32 away from the front arm 31, as shown in Figure 13, the needle-shaped member 34 engaged with the engaging member 4b moves backward through the hole (hereinafter referred to as the second perforation) formed when the needle-shaped member 34 was inserted into the protruding portion P and returns to one surface side of the protruding portion P. This results in a state in which a part of the suture thread 4 (a part on the engaging member 4b side) passes through the second perforation formed in the protruding portion P.

[0082] As a result, both of the pair of engaging members 4a, 4b to which both ends of the suture 4 are fixed are engaged with one needle-shaped member 34. The suture 4 forms a loop that passes from the needle-shaped member 34 arranged on one side of the protruding portion P through the first perforation, exits on the other side of the protruding portion P, passes through the second perforation from the other side of the protruding portion P, and returns to the needle-shaped member 34.

[0083] 14, arm operating unit 33 is operated to move needle-shaped member 34 away from protruding portion P. This causes both ends of suture 4 to move away from protruding portion P, thereby pulling together the suture 4 that has passed through the first perforation and the suture 4 that has passed through the second perforation.

[0084] Next, the suture 4 is ligated. For this operation, the ligation device 2 shown in Figure 20 is used. First, the sheath 22 of the ligation device 2 described above is inserted through the channel of the endoscope 1, and the distal end of the sheath 22 is positioned near the connecting loop 122 of the medical marker 100 attached to the large diameter portion 34a of the needle-shaped member 34. Note that this insertion operation is performed with the slider portion 28 slid toward the proximal end relative to the base portion 27, and the connecting hook 21 provided at the distal end of the drive wire 23 recessed from the distal end of the sheath 22 and housed inside the sheath 22.

[0085] Thereafter, the slider portion 28 is slid toward the distal end relative to the base portion 27, and the connecting hook 21 provided at the distal end of the drive wire 23 is pushed out (protruded) from the distal end of the sheath 22, causing the pair of arm portions 21a to open in an approximately V-shape due to their own elasticity.

[0086] Next, the pair of arms 21a of the connecting hook 21 are brought close to a position where they can grasp the connecting loop 122 of the medical marker 100. In this state, when the base portion 27 is slid toward the distal end relative to the slider portion 28 while maintaining the position of the slider portion 28, the sheath 22 moves toward the distal end, and the pair of arms 21a of the connecting hook 21 protruding from the distal end of the sheath 22 are retracted into the interior and closed.

[0087] As a result, the pair of arms 21a (claws 21b) of the connecting hook 21 grip the connecting loop 122 without shifting the position of the medical marker 100. In this state, when the base portion 27 is further slid toward the distal end relative to the slider portion 28, the connecting loop 122 gripped by the pair of arms 21a is pulled inward from the distal end of the sheath 22, and the distal end surface of the sheath 22 abuts against the base end surface 130b of the tube 130. As a result, the medical marker 100 is connected to the distal end of the sheath 22 of the ligation device 2 in an unligated state.

[0088] Next, when the tip of the sheath 22 to which the medical marker 100 is connected is moved toward the protrusion P (downward in FIG. 15), the engaging members 4a and 4b attached to the suture 4 pass through the ligation loop 121 of the medical marker 100, and both ends of the suture 4 are inserted inside the ligation loop 121 of the medical marker 100, as shown in FIG. 15. This causes the suture 4 to be constricted. In this state, when the base portion 27 is further slid toward the distal end relative to the slider portion 28, the connecting loop 122 is drawn further inside the sheath 22, and the tube 130, which is pressed against the distal end surface of the sheath 22, slides toward the tip of the medical marker 100 (toward the engaging portion 151 of the medical marker 100), and both ends of the suture 4 are bundled together.

[0089] When base portion 27 is further slid toward the distal end relative to slider portion 28 from the state in which both ends of suture 4 are bundled, connecting portion 152 is drawn into the lumen of tube 130 together with suture 4, and connecting portion 152 and suture 4 are housed in a tightly packed and compressed state within tube 130, as shown in Figure 16. At this time, distal end surface 130a of tube 130 abuts against proximal end surface 151a of locking portion 151, and connecting portion 152 and part of loop portion 110 of loop member 105 and suture 4 are housed in a fastened state within tube 130 (the state shown in Figures 2 and 5). This reliably fixes suture 4 and loop portion 110 so that they do not fall out of tube 130.

[0090] After the suture 4 and the loop portion 110 are fixed by the tube 130, when the base portion 27 is slid toward the proximal end relative to the slider portion 28 while maintaining the position of the slider portion 28, the sheath 22 moves toward the proximal end, and the connecting loop 122 and the connecting hook 21 protrude (expose) from the distal end of the sheath 22. As a result, the pair of arms 21a of the connecting hook 21 open due to their own elasticity, the grip of the connecting loop 122 is released, and the medical marker 100 with the suture 4 ligated thereto is separated from the ligation device 2, as shown in FIG.

[0091] 18, the suture thread 4 between the medical marker 100 and the suturing device 3 is cut using an endoscopic scissors forceps or the like called a loop cutter, to separate the medical marker 100 from the suturing device 3. If necessary, the connecting loop 122 of the medical marker 100 in the ligated state may be cut using a loop cutter or the like and collected (the state shown in FIGS. 3 and 6).

[0092] When placing multiple medical markers 100 near the tumor 7, the suturing device 3 is removed from the body, and then a new suturing device 3 equipped with a new medical marker 100 is inserted into the body, and the above-described steps are repeated. This allows multiple medical markers 100 to be attached to the inner wall of the hollow organ located near the tumor 7, as shown in Figure 19. When the desired number of medical markers 100 have been placed, the procedure for placing the medical markers 100 is complete.

[0093] The medical marker 100 placed inside the body as described above has at least one of the loop member 105 and the tube 130 that make up the medical marker 100 partially or entirely composed of a fluorescent material containing a fluorescent dye. The medical marker 100 is placed inside the body attached to the body tissue that is the inner wall of a hollow organ, and the fluorescence of the fluorescent material that makes up the medical marker 100 can be visually recognized from outside the hollow organ. For example, before surgery that approaches the hollow organ from the outside, one or more medical markers 100 are placed near a lesion (tumor 7) as described above, and during surgery, excitation light is irradiated from outside the hollow organ and the fluorescence emitted by the components that make up the medical marker 100 is visually recognized using a camera or the like depending on the wavelength of the fluorescence, etc., thereby identifying the position of the medical marker 100, and thereby making it possible to identify the position of the lesion (tumor 7) from outside the hollow organ.

[0094] Furthermore, a suture 4 containing a fluorescent dye may be used as the suture 4 to be ligated with the medical marker 100. By ligating the suture 4 containing a fluorescent dye using the medical marker 100 that contains a fluorescent substance, it becomes possible to further improve the visibility of the fluorescence from outside the hollow organ.

[0095] In addition, in the above-described embodiment, an example was described in which the medical marker 100 was placed inside a tubular organ by ligating a suture 4 sewn into the tubular organ with the medical marker 100. However, the object to which the medical marker 100 is attached is not limited to the suture 4, and it can also be placed inside a tubular organ by attaching it to a protrusion (polyp, tumor, etc.) inside the tubular organ.

[0096] The function of the medical marker 100 in the above-described embodiment will be described below.

[0097] The medical marker 100 in the above-described embodiment comprises a loop member 105 having a loop portion 110 composed of endless wires 111 and 112, and a tube 130 slidably fitted onto the loop portion 110 of the loop member 105. In the medical marker 100, a part or the whole of at least one of the loop member 105 and the tube 130 is made of a fluorescent material containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.

[0098] According to the above configuration, at least one of the loop member 105 and the tube 130 constituting the medical marker 100 is partially or entirely made of a fluorescent material 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 hollow organ when the medical marker 100 is used to ligate a suture 4 or the like sutured to the inner wall of the hollow organ, thereby providing a medical marker 100 that is highly stable in attachment to the inner wall of the hollow organ and has an extended retention period. Furthermore, because the fluorescent material is placed near the inner wall of the hollow organ, the position of the medical marker 100 can be identified by visually observing the fluorescence emitted by the fluorescent material, thereby providing a medical marker 100 that is highly visible from outside the hollow organ.

[0099] In the medical marker 100 in the above-described embodiment, the loop member 105 may have a locking portion 151 configured to prevent it from being drawn into the lumen of the tube 130 .

[0100] According to the above configuration, when attempting to ligate a suture 4 or the like sutured to the inner wall of a tubular organ with the loop portion 110 in order to attach the medical marker 100 inside the tubular organ, the loop member 105 is prevented from falling out of the tube 130, thereby providing a medical marker 100 that is easy to place.

[0101] In the medical marker 100 in the above-described embodiment, the locking portion 151 of the loop member 105 may be made partly or entirely of a fluorescent material.

[0102] According to the above configuration, when the medical marker 100 is attached to the inner wall of a hollow organ, the locking portion 151 made of a fluorescent material is positioned near the inner wall of the hollow organ, thereby providing a medical marker 100 with excellent visibility from outside the hollow organ.

[0103] The above-described embodiments have been described to facilitate understanding of the present invention, and are not intended to limit the present invention. Therefore, each element disclosed in the above-described embodiments is intended to include all design modifications and equivalents that fall within the technical scope of the present invention. [Explanation of symbols]

[0104] 1. Endoscope 1a Endoscope attachment 2 Ligation device 3 Suturing device 4 sutures 4a, 4b Engagement members 5 Mucosa 6 Serosa 7 Tumor 21 Connecting hook 21a Arm section 21b Claw part 22 Sheath 23 Drive wire 24 Tip member 25 Base side locking member 26 Sheath side locking member 27 Base 28 Slider section 31 Front arm 31s Forked part 32 Rear arm 32a Strip material 33 Arm operating unit 33a case tube 33b Rear arm movement tube 33c Front arm movement tube 34 Needle-shaped member 34a Large diameter section 34b Medium diameter part 34c small diameter section 34d Arrowhead 100 Medical Markers 100a Ligation part 105 Loop member 110 Loop section 111, 112 wire rod 111a, 112a Tip side curved part 111b, 112b Proximal curved part 111c, 112c Tip (tip of wire) 111d, 112d Base end (base end of wire) 113 Proximal connection part 121 Ligation Loop 122 Connecting loop 130 tubes 130a Tip surface (tip surface of tube) 130b Base end surface (base end surface of tube) 151 Locking part 151a base end surface (base end surface of locking portion) 152 Connection part 152a Base end surface (base end surface of connection part) P protrusion

Claims

[Claim 1] A medical marker that is placed in a hollow organ in the body and makes the placement position visible from outside the hollow organ, a loop member having a loop portion formed of an endless wire; a tube that is slidably fitted onto the distal end side of the medical marker relative to the loop portion of the loop member, the loop member has a locking portion on the distal end side of the medical marker that is configured to prevent the loop member from being drawn into the lumen of the tube; A medical marker characterized in that a part or the whole of the fastening portion of the loop member is made of a fluorescent material containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.

Images