Medical markers
The deformable locking portions and phosphor-equipped medical marker ensure stable and visible attachment within tubular organs, addressing the gripping force limitations of existing markers by enhancing retention and safety.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-09-06
- Publication Date
- 2026-03-18
AI Technical Summary
Existing medical markers for tubular organs lack sufficient gripping force, leading to short retention times and instability, necessitating rapid surgical procedures like thoracotomy or laparoscopic surgery for attachment, which is inconvenient and limiting their utility.
A medical marker with deformable locking portions that can be inserted perpendicularly into the tubular organ wall, expanding outward for stable attachment, and equipped with a phosphor for external visibility, allowing longer retention and improved stability.
The medical marker provides enhanced mounting stability and visibility, enabling longer retention within the tubular organ and reducing the risk of damage to the organ, facilitating safer and more reliable surgical procedures.
Smart Images

Figure 2026049396000001_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to a medical marker that can be inserted into a luminal organ using an endoscope and used as a marker that can visually recognize a position from the outside of the luminal organ.
Background Art
[0002] Generally, diseases such as cancer of the digestive tract, such as the esophagus, stomach, and large intestine, mainly occur and progress from the mucosa of the digestive tract. Similarly, lung cancer mainly occurs from the tracheal mucosa, and bladder cancer mainly occurs and progresses from the bladder mucosa. Therefore, in order to confirm the diagnosis of diseases of luminal organs such as the digestive tract, trachea, and bladder, it is essential to insert an endoscope into the luminal organ to observe the mucosa and perform a biopsy on the affected tissue. Then, based on the definitive diagnosis, the affected tissue is surgically removed as necessary.
[0003] However, in surgical resection, since the surgeon approaches from the outside of the luminal organ, it is not possible to directly visually recognize the affected part inside the luminal organ. That is, under open chest or open abdominal surgery or laparoscopic surgery, when observing the digestive tract, trachea, or bladder with the naked eye or a laparoscope, what can be seen is not the mucosa but the serosal surface of the digestive tract, the serosal surface of the trachea, or the peritoneal surface of the bladder. Therefore, in order to determine the resection area even when observed from the outside of the luminal organ, it is necessary to perform marking from the inside of the luminal organ.
[0004] As a marker for performing such marking, for example, a medical marker described in Patent Document 1 below is known. Patent Document 1 describes a clip-shaped medical marker having a pair of arm plate portions that elastically open at a substantially V shape, claw portions formed at each tip of the arm plate portions, and a tightening ring that is attached to the arm plate portions so as to be movable along the longitudinal direction of the pair of arm plate portions and closes the pair of arm plate portions by moving in the direction of the claw portions, and a fluorescent member containing a fluorescent dye that emits fluorescence in a predetermined wavelength range by irradiation 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 claw portions. [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 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). This creates a constraint in the medical field, requiring the attachment of the medical marker using an endoscope and the procedure by thoracotomy, abdominal surgery, or laparoscopic surgery to be performed in a short period of time. Therefore, there is a demand in the medical field for medical markers that can be left in the body for a longer period of time 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 implanted in a tubular organ in the body, comprising a main body extending in the longitudinal direction, and two or more locking portions extending from a proximal end fixed to a part of the distal side of the main body to a tip, wherein the locking portions are configured to be deformable into a curved state in which they are curved laterally from the proximal end so that the tip is positioned proximal to the proximal end, and an extended state in which they extend longitudinally from the proximal end, and a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light is arranged on the main body or the locking portions.
[0010] According to the above configuration, the two or more locking portions of the medical marker are each configured to be deformable into a curved state in which they are curved laterally from the proximal end so that the tip is positioned proximal to the proximal end, and an extended state in which they extend longitudinally from the proximal end.
[0011] This allows the locking portion to be inserted into the inner wall of a tubular organ from a nearly perpendicular direction when the extended locking portion is inserted, enabling smooth attachment to the inner wall of the tubular organ. Furthermore, the locking portion is designed to be curved, and as it penetrates the inner wall of the tubular organ, it expands outward while returning to the inside of the tubular organ, allowing for stable attachment of the medical marker to the inner wall of the tubular organ. This provides a medical marker with excellent attachment stability and an improved period of indwelling.
[0012] Furthermore, since the main body and locking portion of the medical marker are equipped with a phosphor, the phosphor can be positioned near the inner wall of a tubular organ by attaching the medical marker to the inner wall of the tubular organ. This allows the location of the medical marker to 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.
[0013] The medical marker according to the present invention may be configured such that the locking portion has a first curved portion which is deformable into a curved state in which a base end fixed to a part of the distal side of the main body is curved in a direction away from the longitudinal central axis of the main body and an extended state which extends along the longitudinal direction, and a second curved portion which is deformable into a curved state in which a base end fixed to a part of the distal side of the main body is curved in a direction away from the longitudinal central axis of the main body from the connection point with the first curved portion and an extended state which extends along the longitudinal direction.
[0014] According to the above configuration, the first curved portion is shaped to curve away from the longitudinal central axis of the main body. This allows the locking portion to penetrate the inner wall of a tubular organ, while the first curved portion expands outward within the inner wall of the tubular organ before returning to the inside of the tubular organ.
[0015] Furthermore, the second curved section, connected to the first curved section, is bent to curve in a direction close to the longitudinal central axis of the main body. As a result, when the locking section is curved, the tip of the locking section is directed inward (towards the main body) by the second curved section. Therefore, even if the medical marker detaches from the inner wall of a tubular organ and becomes loose inside the organ, the risk of the tip damaging the inner wall of the organ can be reduced. In addition, the safety of the medical marker can be improved, as can the mounting stability.
[0016] The medical marker according to the present invention, in the above configuration, comprises a main body comprising a base material that fixes the base end of the locking portion, and a cylindrical member fitted onto the base material and slidable longitudinally relative to the base material, wherein when the cylindrical member slides proximal to the base material, the first curved portion and the second curved portion are exposed to the outside from the distal end of the cylindrical member and are in a curved state, and when the cylindrical member slides distal to the base material, the first curved portion and the second curved portion are drawn into the lumen of the cylindrical member from the distal end and are in an extended state.
[0017] According to the above configuration, by sliding the cylindrical member against the base material, the first and second curved portions constituting the locking portion can be deformed, and the first and second curved portions can be inserted into the inner wall of a tubular organ in an extended state, and then deformed back into a curved state so as to return to the inside of the tubular organ, thereby attaching to the inner wall of the tubular organ.
[0018] In the above configuration, the medical marker according to the present invention comprises two or more longitudinally extending arm portions, the proximal ends of which are connected, and the base end of the locking portion may be fixed to each of the distal ends of the two or more arm portions.
[0019] According to the above configuration, the base material can be made up of an arm portion extending in the longitudinal direction, and a locking portion can be provided at the distal end of the arm portion, thereby realizing a simple configuration in which the arm portion and the locking portion that constitute the main body are integrated.
[0020] In the medical marker according to the present invention, in the above configuration, part or all of the cylindrical member may be composed of the phosphor.
[0021] With the above configuration, when a medical marker is attached to the inner wall of a tubular organ, the cylindrical member positioned near the inner wall surface of the tubular organ emits fluorescence, making the fluorescence visible from the outside of the tubular organ. Furthermore, it becomes possible to select a metal or other material that improves the locking function as the material of the locking part, thereby further improving the stability of the attachment of the medical marker.
[0022] In the medical marker according to the present invention, the fluorescent material may be coated on part or all of the locking portion in the configuration described above.
[0023] According to the above configuration, since the locking portion of the medical marker attached to the inner wall of the luminal organ emits fluorescence, the fluorescence from the outside of the luminal organ can be visually recognized. In addition, as the material of the locking portion, a metal or the like that improves the locking function can be selected, and the mounting stability of the medical marker can be further improved.
[0024] In the medical marker according to the present invention, in the above configuration, the locking portions may be arranged at equal intervals along the circumferential direction of the central axis in the longitudinal direction of the main body portion.
[0025] According to the above configuration, the medical marker can be attached to the inner wall of the luminal organ at two or more isotropically arranged locking positions, and the mounting stability of the medical marker can be further improved.
[0026] In the medical marker according to the present invention, in the above configuration, the tip portion may be formed to be sharp toward the tip side.
[0027] According to the above configuration, the penetrability of the locking portion into the inner wall of the luminal organ can be further improved.
Brief Description of the Drawings
[0028] [Figure 1] It is a perspective view showing the curved state of the locking portion of the medical marker in the first embodiment of the present invention. [Figure 2] It is a side view showing the curved state of the locking portion of the medical marker in the first embodiment of the present invention. [Figure 3] It is a perspective view showing the extended state of the locking portion of the medical marker in the first embodiment of the present invention. [Figure 4] It is a side view showing the extended state of the locking portion of the medical marker in the first embodiment of the present invention. [Figure 5] It is a view showing the whole delivery device for leaving the medical marker in the body in the first embodiment of the present invention. [Figure 6]This is a partial side view showing a medical marker in an extended state attached to the distal end of a delivery device in a first embodiment of the present invention. [Figure 7] This is a partial side view showing how a medical marker is deformed into a curved state using a delivery device in a first embodiment of the present invention. [Figure 8] This figure illustrates the procedure for implanting a medical marker in a tubular organ according to the first embodiment of the present invention. [Figure 9] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the first step of the procedure for implanting a medical marker in a tubular organ according to the first embodiment of the present invention. [Figure 10] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the second step of the procedure for implanting a medical marker in a tubular organ according to the first embodiment of the present invention. [Figure 11] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the third step of the procedure for implanting a medical marker in a tubular organ according to the first embodiment of the present invention. [Figure 12] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the fourth step of the procedure for implanting a medical marker in a tubular organ according to the first embodiment of the present invention. [Figure 13] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the fifth step of the procedure for implanting a medical marker in a tubular organ according to the first embodiment of the present invention. [Figure 14] This figure shows the sixth step in the procedure for implanting a medical marker into a tubular organ according to the first embodiment of the present invention. [Figure 15] This is a perspective view showing the curved state of the locking portion of the medical marker in the second embodiment of the present invention. [Figure 16] This is a side view showing the curved state of the locking portion of the medical marker in the second embodiment of the present invention. [Figure 17] This is a perspective view showing the extended state of the locking portion of the medical marker in the second embodiment of the present invention. [Figure 18]This is a side view showing the extended state of the locking portion of the medical marker in the second embodiment of the present invention. [Figure 19] This is a partial side view showing a medical marker in an extended state attached to the distal end of a delivery device in a second embodiment of the present invention. [Figure 20] This is a partial side view showing how a medical marker is deformed into a curved state using a delivery device in a second embodiment of the present invention. [Figure 21] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the first step of the procedure for implanting a medical marker in a tubular organ according to the second embodiment of the present invention. [Figure 22] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the second step of the procedure for implanting a medical marker in a tubular organ according to the second embodiment of the present invention. [Figure 23] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the third step of the procedure for implanting a medical marker in a tubular organ according to the second embodiment of the present invention. [Figure 24] This is a perspective view showing the curved state of the locking portion of the medical marker in the third embodiment of the present invention. [Figure 25] This is a perspective view showing the extended state of the locking portion of the medical marker in the third embodiment of the present invention. [Figure 26] This is a partial side view showing a medical marker in an extended state attached to the distal end of a delivery device in a third embodiment of the present invention. [Figure 27] This is a partial side view showing how a medical marker is deformed into a curved state using a delivery device in a third embodiment of the present invention. [Figure 28] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the first step of the procedure for implanting a medical marker in a tubular organ according to the third embodiment of the present invention. [Figure 29] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the second step of the procedure for implanting a medical marker in a tubular organ according to the third embodiment of the present invention. [Figure 30]This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the third step of the procedure for implanting a medical marker in a tubular organ according to the third embodiment of the present invention. [Figure 31] This is a perspective view showing the curved state of the locking portion of the medical marker in the fourth embodiment of the present invention. [Figure 32] This is a perspective view showing the extended state of the locking portion of the medical marker in the fourth embodiment of the present invention. [Figure 33] This is a partial side view showing a medical marker in an extended state attached to the distal end of a delivery device in a fourth embodiment of the present invention. [Figure 34] This is a partial side view showing how a medical marker is deformed into a curved state using a delivery device in a fourth embodiment of the present invention. [Figure 35] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the first step of the procedure for implanting a medical marker in a tubular organ according to the fourth embodiment of the present invention. [Figure 36] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the second step of the procedure for implanting a medical marker in a tubular organ according to the fourth embodiment of the present invention. [Figure 37] This is a schematic enlarged view of the vicinity of region A in Figure 8, and shows the third step of the procedure for implanting a medical marker in a tubular organ according to the fourth embodiment of the present invention. [Modes for carrying out the invention]
[0029] The first to fourth embodiments of the present invention will be described below with reference to the drawings. In this specification, the patient's internal side is considered the distal side, and the operator's hand side is considered the proximal side, with the operator implanting the medical marker according to the present invention as the reference point. The drawings referenced in this specification do not necessarily have an accurate scale to the actual dimensions, and some parts are exaggerated or simplified in order to schematically illustrate the configuration according to the present invention.
[0030] (First Embodiment) A first embodiment of the present invention will now be described. First, the configuration of the medical marker 100 in the first embodiment of the present invention will be described with reference to Figures 1 to 4. Figure 1 is a perspective view showing the curved state of the locking portion 150 of the medical marker 100 in the first embodiment of the present invention, and Figure 2 is a side view showing the curved state of the locking portion 150 of the medical marker 100 in the first embodiment of the present invention. Figure 3 is a perspective view showing the extended state of the locking portion 150 of the medical marker 100 in the first embodiment of the present invention, and Figure 4 is a side view showing the extended state of the locking portion 150 of the medical marker 100 in the first embodiment of the present invention. Note that in Figures 2 and 4, the cylindrical member 140 is shown as a transparent element.
[0031] The medical marker 100 in the first embodiment is a medical marker 100 that is implanted in a tubular organ in the body, and as shown in Figures 1 to 4, it generally comprises a main body 120 and two locking parts 150 fixed to a part of the distal side of the main body 120. The medical marker 100 shown in Figures 1 to 4 has two locking parts 150, but it may have three or more locking parts 150.
[0032] The main body portion 120 is a member that extends in the longitudinal direction L as a whole. In the first embodiment, the main body portion 120 is composed of a base material 130 and a cylindrical member 140. The direction connecting the proximal side and the distal side is called the longitudinal direction L. The central axis of the main body portion 120 extending in the longitudinal direction L is called the longitudinal central axis Ax.
[0033] The base material 130 has two arm portions 131 extending in the longitudinal direction L. The proximal ends of the two arm portions 131 are connected by a substantially U-shaped connecting portion 132. The base ends 151 of a locking portion 150 are fixed to the distal ends of the two arm portions 131. The arm portions 131 are made of elongated plate-like members, for example, as shown in Figures 1 to 4. The medical marker 100 shown in Figures 1 to 4 has two arm portions 131, but it may have three or more arm portions 131.
[0034] The cylindrical member 140 is a cylindrical member having a lumen 141 extending in the longitudinal direction L. The cylindrical member 140 is fitted onto the base material 130 and is configured to slide relative to the base material 130 in the longitudinal direction L when fitted onto the base material 130. The central axis of the cylindrical member 140 extending in the longitudinal direction L coincides with the longitudinal central axis Ax. The lumen 141 of the cylindrical member 140 is set to a size that allows the two arm portions 131 and the locking portion 150 constituting the base material 130 to be inserted through.
[0035] The locking portion 150 is positioned distal to the medical marker 100 and is made of a deformable material. The locking portion 150 consists of an elongated plate-like member, as shown in Figures 1 to 4, and has elasticity that allows it to be deformed into a curved state and an extended state, as will be described later.
[0036] The base end 151 of the locking portion 150 is fixed to the distal end of the base material 130 (arm portion 131), which is a part of the distal side of the main body portion 120. The arm portion 131, the connecting portion 132, and the locking portion 150 may be integrally formed from a single plate-like member.
[0037] The medical marker 100 shown in Figures 1 to 4 is equipped with two locking parts 150 connected to two arm parts 131, but it may be equipped with three or more locking parts 150. Furthermore, it is preferable that the locking parts 150 are arranged at equal intervals along the circumferential direction centered on the longitudinal central axis Ax of the main body part 120 and have a shape that is symmetrical with respect to the longitudinal central axis Ax. In the medical marker 100 shown in Figures 1 to 4, the two locking parts 150 are arranged at 180° intervals in the circumferential direction and have a shape that is symmetrical with respect to each other, but for example, if there are three locking parts 150, it is preferable that they be arranged at 120° intervals, and if there are four locking parts 150, it is preferable that they be arranged at 90° intervals. This makes it possible to support the medical marker 100 in a balanced manner.
[0038] The tip 154 of the locking portion 150 is a free end. As will be described later, when attaching the medical marker 100 to the inner wall of a tubular organ, the locking portion 150 is inserted into the inner wall of the tubular organ from its tip 154. To improve the ease with which the locking portion 150 can penetrate the inner wall of the tubular organ, it is preferable that the tip 154 is sharply formed toward the tip.
[0039] When no external force is acting on the locking portion 150, the locking portion 150 is shaped to be curved (curved state). In the curved state, as shown in Figures 1 and 2, the locking portion 150 curves laterally from the base end 151, and is positioned so that the tip 154 is located proximal to the base end 151. That is, as shown in Figure 2, the position of the tip 154 is located proximal to the position of the base end 151 by a distance D1 (D1>0) in the longitudinal direction L, and the curved locking portion 150 is shaped to curve back proximal to the base end 151, which is fixed to the distal end of the base material 130.
[0040] On the other hand, when an external force is applied to the locking portion 150, the locking portion 150 can be deformed into a state that extends in a substantially straight line (extended state). In the extended state, the locking portion 150 has a shape that extends in the longitudinal direction L toward the distal side from the base end portion 151, as shown in Figures 3 and 4.
[0041] More specifically, as shown in Figures 1 to 4, the locking portion 150 of the medical marker 100 is configured to include a first curved portion 152 connected to the base portion 151 and a second curved portion 153 connected to the tip of the first curved portion 152, between the base portion 151 and the tip portion 154. The first curved portion 152 is deformable into a curved state in which it is bent away from the longitudinal central axis Ax from the base portion 151 fixed to the distal end of the base material 130 (arm portion 131), which is a part of the distal side of the main body portion 120, and an extended state in which it extends along the longitudinal direction L. The second curved portion 153 is also deformable into a curved state in which it is bent away from the longitudinal central axis Ax of the main body portion 120 from the connection point P where it connects to the first curved portion 152, and an extended state in which it extends along the longitudinal direction L.
[0042] In the medical marker 100 of the first embodiment, the locking portion 150 can be deformed into a curved or extended state by sliding the cylindrical member 140 fitted onto the base material 130 in the longitudinal direction L relative to the base material 130.
[0043] When the cylindrical member 140 is slid proximal, as shown in Figures 1 and 2, the cylindrical member 140 is positioned to fit over the base material 130 located proximal to the locking portion 150. At this time, no external force acts on the locking portion 150, and the first curved portion 152 and the second curved portion 153 constituting the locking portion 150 deform into a curved state. Alternatively, for example, the width of the proximal ends of the two arm portions 131 may be made larger than the lumen 141 of the cylindrical member 140, preventing the cylindrical member 140 from sliding proximal to a predetermined position. This prevents the cylindrical member 140 from falling out proximal to the connecting portion 132 and also allows the cylindrical member 140 to be fixed in a predetermined position.
[0044] On the other hand, when the cylindrical member 140 is slid distally, as shown in Figures 3 and 4, the cylindrical member 140 is positioned so as to fit the locking portion 150 onto it. At this time, the locking portion 150 is drawn into the lumen 141 of the cylindrical member 140 in the order of the second curved portion 153 and the first curved portion 152, while contacting the inner circumferential surface of the cylindrical member 140. The first curved portion 152 and the second curved portion 153 constituting the locking portion 150 are pressed from the inner circumferential surface of the cylindrical member 140, extending in the longitudinal direction L and deforming into an elongated state.
[0045] The second curved portion 153, connected to the tip of the first curved portion 152, is shaped to curve in a direction close to the longitudinal central axis Ax, and the tip portion 154 of the locking portion 150 in the curved state is oriented inward (towards the main body portion 120) by the second curved portion 153. That is, in the curved state, the angle θ (see Figure 2) that the direction of the tip portion 154 makes with respect to the longitudinal central axis Ax is set to be greater than 180°. The angle θ is preferably greater than 180°, and more preferably greater than 225°.
[0046] Furthermore, the locking portion 150 may be configured to include a third curved portion connected to the tip side of the second curved portion 153, and the third curved portion may be shaped to curve in a direction away from the longitudinal central axis Ax. This may cause the angle θ to be greater than 270°.
[0047] In this way, by making the angle θ greater than 180°, the tip 154 can be prevented from pointing outward from the medical marker 100, thereby reducing the risk of damage to the inner wall of the tubular organ by the sharply formed tip 154 and improving the safety of the medical marker 100. Furthermore, even if, for example, the medical marker 100 detaches from the inner wall of the tubular organ and becomes free within the tubular organ, the risk of damage to the inner wall of the tubular organ by the tip 154 can be reduced.
[0048] Furthermore, by making the angle θ greater than 180°, in the curved state, the position of the tip portion 154 is positioned inward in the width direction from the outermost position of the locking portion 150. That is, as shown in Figure 2, the position of the tip portion 154 is positioned inward by a distance D2 (D2>0) in the width direction from the outermost position of the locking portion 150. This improves the mounting stability of the medical marker 100.
[0049] In the first embodiment, one or both of the main body portion 120 and the locking portion 150 constituting the medical marker 100 are arranged on 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 main body portion 120 may be made of phosphor, or part or all of the main body portion 120 may be coated with phosphor. Alternatively, part or all of the locking portion 150 may be made of phosphor, or part or all of the locking portion 150 may be coated with phosphor.
[0050] As described later, when implanting the medical marker 100 in the body, for example, the medical marker 100 can be inserted into the body using the delivery device 2 described later and attached to the inner wall of a tubular organ. By placing a phosphor on the medical marker 100, the phosphor can be attached to the inner wall of a tubular organ, and the fluorescence of the phosphor can be visually observed from the outside of the tubular organ.
[0051] 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.
[0052] 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, light resistance, and heat resistance.
[0053] A phosphor containing a fluorescent dye can be manufactured using a polymer material composition. For example, when manufacturing the main body 120 or the locking part 150 by injection molding, the entire main body 120 or locking part 150 can be made to contain the fluorescent dye by using a polymer material containing a fluorescent dye as the molten material. Alternatively, part or all of the phosphor can be manufactured using a matrix made of an inorganic material 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 an inorganic material may be used as the phosphor to be placed in the medical marker 100.
[0054] One method for incorporating a fluorescent dye into a polymer material is to use a twin-screw kneader to knead the fluorescent dye into the polymer material.
[0055] 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 0.1 to 0.001% by mass.
[0056] Polyurethane, polycarbonate, polypropylene, polyethylene, polyvinyl chloride, polyamide, polyamide elastomer, and the like can be used as polymer materials containing fluorescent dyes.
[0057] The polymer material composition containing the fluorescent dye may optionally contain an X-ray opaque contrast agent such as barium sulfate. 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.
[0058] Furthermore, considering the protection of the phosphor and its potential impact on living organisms, the outer surface of the phosphor may be further coated with a transparent material that does not contain fluorescent dyes.
[0059] The medical marker 100 is attached to the inner wall of a tubular organ by piercing the locking portion 150 through the inner wall of the tubular organ. As described above, part or all of the locking portion 150 may be made of a phosphor, but it is preferable that the locking portion 150 has sufficient strength to pierce the inner wall of the tubular organ and maintain its attachment to the inner wall of the tubular organ. Therefore, when a phosphor is placed on the locking portion 150, it is preferable to coat the locking portion 150, which is made of a metal such as nickel-titanium alloy or stainless steel, with the phosphor.
[0060] Furthermore, as described above, a phosphor may be placed on a part of the main body 120. In this case, it is preferable to place the phosphor on the arm portion 131 located on the distal side of the main body 120 (the side closer to the inner wall of the tubular organ when placed) so that the phosphor is easily visible from the outside of the tubular organ when the medical marker 100 is attached to the inner wall of the tubular organ.
[0061] In the first embodiment, preferred configurations of the medical marker 100 include, in order to improve the attachment strength to the inner wall of a tubular organ, integrally forming the base material 130 and the locking portion 150 from a metal such as nickel-titanium alloy or stainless steel, and then constructing part or all of the cylindrical member 140 with a phosphor, or coating part or all of the locking portion 150 with a phosphor.
[0062] The following describes examples of how the medical marker 100 described above can be used. In the first embodiment, the medical marker 100 can be implanted in the body using, for example, the delivery device 2 shown in Figure 5.
[0063] Referring to Figure 5, the delivery device 2 for implanting the medical marker 100 in the body according to the first embodiment will be described. Figure 5 is a diagram showing the overall structure of the delivery device 2 for implanting the medical marker 100 in the body according to the first embodiment of the present invention. The delivery 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 section having a base part 27 and a slider part 28.
[0064] The sheath 22 consists of a flexible hollow tube. While a simple tube made of resin or the like may be used as the sheath 22, a coil tube is used in this embodiment. As the coil tube, a flat wire coil tube can be used, which is made by spirally winding a long flat plate made of metal (stainless steel) or the like. However, a round wire coil tube or an inner flat coil tube may also be used. In addition, a wire tube may be used as the sheath 22. A wire tube is a tube made of a hollow stranded wire, which is made by spirally twisting multiple wires (cables) made of metal (stainless steel) or the like to create a hollow structure.
[0065] A substantially cylindrical tip member 24 is integrally fixed to the distal end of the coil tube of the sheath 22, and the distal end face of the tip member 24 is a contact portion that can abut against the proximal end face of the cylindrical member 140 of the medical marker 100. However, from the viewpoint of reducing costs and the number of parts, the tip member 24 may be omitted.
[0066] The drive wire 23 is made of a flexible wire, and in this embodiment, a wire rope is used. The wire rope is a rope made of stranded wire formed by twisting multiple wires (cables) made of metal such as stainless steel in a spiral shape. However, a single wire may also be used as the drive wire 23.
[0067] A connecting hook 21 is integrally attached to the tip (distal end) of the drive wire 23. The connecting hook 21 is an elastic body having a pair of arm portions 21a arranged to spread outwards in a roughly V-shape towards its tip, and claw portions 21b formed by bending the tips of the arm portions 21a inwards. The base ends of the arm portions 21a are integrated together in a roughly U-shape. The arm portions 21a can be inserted into an annular member welded and fixed to the tip (distal end) of the drive wire 23, and may be able to pivot relative to the drive wire 23.
[0068] The connecting hook 21 extends outwards in a roughly V-shape by its own elasticity when the sheath 22 is slid proximally toward the drive wire 23, protruding from the distal end of the sheath 22. Conversely, when the sheath 22 is slid distally toward the drive wire 23, it becomes embedded inside the distal end of the sheath 22 and closes.
[0069] By holding the drive wire 23 in a fixed position and operating it to push out the sheath 22, 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.
[0070] The proximal end (base end) of the sheath 22 through which the drive wire 23 is inserted is detachably 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.
[0071] A slider section 28 is slidably attached to the base section 27, and the proximal end of the drive wire 23 extends to the slider section 28 and is detachably fixed to the slider section 28 via a locking screw 29.
[0072] 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 opens into a roughly 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 embedded from the distal end of the sheath 22 and housed inside the sheath 22.
[0073] When connecting the medical marker 100 to the distal end of the sheath 22 of the delivery device 2, the base portion 27 is slid proximal to the slider portion 28 to pull the sheath 22 into the drive wire 23, causing the connecting hook 21 at the distal end of the drive wire 23 to protrude from the distal end of the sheath 22, and causing it to spread in a roughly V-shape due to its own elasticity.
[0074] From this state, when the base portion 27 is slid distally relative to the slider portion 28, the sheath 22 is pushed out relative to the drive wire 23, and the connecting hook 21 at the distal end of the drive wire 23 enters the sheath 22, causing the legs to gradually close.
[0075] The connection of the medical marker 100 to the delivery device 2 shown in Figure 5 will be explained with reference to Figures 6 and 7. Figure 6 is a partial side view showing the medical marker 100 in an extended state attached to the distal end of the delivery device 2 in a first embodiment of the present invention. Figure 7 is a partial side view showing the medical marker 100 in a curved state using the delivery device 2 in a first embodiment of the present invention. In Figures 6 and 7, the delivery device 2 is drawn with a dashed line and is shown transparently, and the cylindrical member 140 is also shown transparently.
[0076] When the medical marker 100 is delivered into the body, the medical marker 100 is attached to the delivery device 2 in an extended state with the cylindrical member 140 positioned distally and the locking portion 150 extended. For example, the connecting portion 132 located on the proximal side of the extended or curved medical marker 100 is positioned so that the connecting hook 21 grips it, and the connecting hook 21 is completely closed. Furthermore, the base portion 27 is slid distally relative to the slider portion 28 to embed the connecting hook 21 into the sheath 22. As a result, as shown in Figure 6, the connecting portion 132 is gripped by the connecting hook 21, and the medical marker 100 can be attached to the distal end of the sheath 22 with the distal end surface of the tip member 24 in contact with the proximal end surface of the cylindrical member 140 of the medical marker 100.
[0077] When attaching the medical marker 100 to the inner wall of a tubular organ, the medical marker 100 is deformed from an extended state to a curved state by the action of the delivery device 2. Specifically, when the base portion 27 is slid proximal to the slider portion 28 while pressing the distal end face of the cylindrical member 140, which is positioned distal to the medical marker 100, against the inner wall of the tubular organ, the connecting hook 21 at the distal end of the drive wire 23 slides distally while the cylindrical member 140 is sandwiched and fixed between the inner wall of the tubular organ and the distal end face of the tip member 24. As a result, the arm portion 131 and the locking portion 150 connected to the connecting portion 132, which is gripped by the connecting hook 21, move distally to the cylindrical member 140 and are pushed out together, and the locking portion 150 is released from the external force of the cylindrical member 140 and deformed into a curved state, as shown in Figure 7.
[0078] To release the connection of the medical marker 100 to the distal end of the sheath 22 from this state, the base portion 27 is slid proximal to the slider portion 28 while lifting the distal end of the delivery device 2 away from the inner wall of the tubular organ, thereby sliding the sheath 22 proximal to the drive wire 23. This exposes the connecting hook 21 from the distal end of the sheath 22, causing it to spread open and releasing the grip (connection) of the connecting portion 132 by the connecting hook 21, allowing the medical marker 100 to be separated from the delivery device 2.
[0079] Next, the procedure for implanting the medical marker 100 in the first embodiment will be described with reference to Figures 8 to 14. Below, the implantation procedure for attaching the medical marker 100 near a lesion (tumor 7) on the inner wall of a tubular organ (such as the inner wall of a bile duct) will be described.
[0080] Figure 8 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 9 to 13 are schematic enlarged views of the vicinity of region A in Figure 8, illustrating the first to sixth steps of the procedure for implanting a medical marker 100 into a tubular organ, and Figure 14 shows the state in which multiple medical markers 100 have been implanted into a tubular organ. For clarity in the illustration, the mucosa 5 and serosal membrane 6 of the tubular organ are shown in cross-section in Figures 8 to 14. In addition, in Figures 9 to 12, the delivery device 2 is drawn with a dotted line, and the cylindrical member 140 of the medical marker 100 is shown in cross-section.
[0081] First, the endoscope 8 is inserted into the body, and its distal end is positioned near the inner wall of the tubular organ where the medical marker 100 will be placed. Then, the distal end of the delivery device 2, to which the extended medical marker 100 is attached (as shown in Figure 6), is advanced through the channel of the endoscope 8, exposing the distal end of the delivery device 2 into the tubular organ, as shown in Figure 8.
[0082] In that state, as shown in Figure 9, the distal end of the delivery device 2 is manipulated to press the distal end face of the cylindrical member 140 located distal to the delivery device 2 against the mucous membrane 5 of the inner wall of the tubular organ. Then, while pressing the distal end face of the cylindrical member 140 against the inner wall of the tubular organ, the base portion 27 is slid proximal to the slider portion 28. As a result, the main body portion 120 and the locking portion 150, which are connected to the connecting portion 132 grasped by the connecting hook 21, move distally to the cylindrical member 140 and are pushed out together, and as shown in Figure 10, the tip portion 154 of the locking portion 150 can be inserted into the mucous membrane 5 of the inner wall of the tubular organ. At this time, if the tip portion 154 is formed to be sharp toward the tip, the tip portion 154 can be smoothly inserted into the mucous membrane 5 of the inner wall of the tubular organ.
[0083] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 150, which has been pushed distal to the cylindrical member 140, is released from the external force of the cylindrical member 140 and deforms into a curved state as it advances through the mucosa 5 of the inner wall of the tubular organ. The tip portion 154 of the locking portion 150 expands laterally within the mucosa 5 of the inner wall of the tubular organ and advances back into the tubular organ, and as shown in Figure 11, it is exposed again from the inner wall of the tubular organ into the tubular organ. The tip portion 154 is exposed again into the tubular organ from a position different from the position where it was penetrated into the inner wall of the tubular organ, and the locking portion 150 is in a state of being penetrated into the mucosa 5 of the inner wall of the tubular organ.
[0084] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 150 is pushed distal to the cylindrical member 140, and as shown in Figure 12, the locking portion 150 is released from the external force of the cylindrical member 140 and deforms back into its original curved state (as shown in Figure 7). Then, by releasing the connection of the medical marker 100 to the distal end of the sheath 22, the medical marker 100 becomes attached to the inner wall of the tubular organ, as shown in Figure 13.
[0085] When implanting multiple medical markers 100 on the inner wall of a tubular organ, the delivery device 2 is removed from the body, a new medical marker 100 is attached to the delivery device 2, the distal end of the delivery device 2 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, as shown in Figure 14. Once the desired number of medical markers 100 have been implanted, the procedure for implanting the medical markers 100 is complete.
[0086] Furthermore, the delivery device 2 can also be used when removing a medical marker 100 implanted in the body from the inner wall of a tubular organ. Specifically, the connecting portion 132 located proximal to the medical marker 100 attached to the inner wall of the tubular organ is grasped with the connecting hook 21, and the base portion 27 is slid distally relative to the slider portion 28. As a result, with the distal end face of the tip member 24 in contact with the proximal end face of the cylindrical member 140, the sheath 22 is pushed out relative to the drive wire 23, and the main body portion 120 and locking portion 150 connected to the connecting portion 132 grasped by the connecting hook 21 move relative to the cylindrical member 140 proximal and are pulled into the sheath 22. The locking portion 150 is pulled out from the inner wall of the tubular organ and pulled into the lumen 141 of the cylindrical member 140, deforming from a curved state to an extended state. This releases the locking portion 150 from its attachment to the inner wall of the tubular organ, allowing the medical marker 100 to be removed from the inner wall of the tubular organ.
[0087] As described above, the medical marker 100 implanted in the body has a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light, arranged on at least one of the main body portion 120 (base material 130 and cylindrical member 140) and the locking portion 150. The medical marker 100 is implanted in the body attached to the inner wall of a tubular organ, and the fluorescence emitted by 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 (e.g., laparoscopic perioperative surgery), 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 phosphor placed on 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, the medical marker 100 can be attached to the inner wall of a tubular organ by penetrating the locking portion 150 through the inner wall of the tubular organ. The locking portion 150 is shaped to be curved, and as it penetrates the inner wall of the tubular organ, it expands outward while returning to the inside of the tubular organ, so that the medical marker 100 can be stably attached to the inner wall of the tubular organ. In addition, since the phosphor placed on the medical marker 100 can be positioned so as to press against the inner wall of the tubular organ, the visibility of the phosphor from the outside of the tubular organ can be improved.
[0089] The locking portion 150 is configured to include a second curved portion 153 that is curved in a direction close to the longitudinal central axis Ax, and the tip portion 154 of the locking portion 150 in the curved state can be directed inward (towards the main body portion 120) by the second curved portion 153. This prevents the tip portion 154 of the medical marker 100, when attached to the inner wall of a tubular organ, from pointing sideways, thereby reducing the risk of the tip portion 154 damaging the inner wall of the tubular organ. Even if the medical marker 100 detaches from the inner wall of the tubular organ and becomes loose inside the tubular organ, the risk of the tip portion 154 damaging the inner wall of the tubular organ can be reduced. Furthermore, since the locking portion 150, which penetrates the inner wall of the tubular organ in an arc, is located inside the position where its tip portion 154 is exposed from the inner wall of the tubular organ, the locking force of the locking portion 150 on the inner wall of the tubular organ can be improved.
[0090] It is preferable that the phosphor of the medical marker 100 attached to the inner wall of a tubular organ be positioned so that it is clearly visible from the outside of the tubular organ. For example, it is preferable to make the distal end or the entire cylindrical member 140 out of phosphor, or to coat the distal end or the entire cylindrical member 140 with phosphor. This allows the cylindrical member 140, which is positioned to be pressed against the inner wall of the tubular organ when the medical marker 100 is placed, to emit fluorescence, making it possible to identify the position of the medical marker 100 from the outside of the tubular organ. It is also preferable to make part or the entire locking portion 150 out of phosphor, or to coat part or the entire locking portion 150 with phosphor. This allows the locking portion 150, which is penetrated into the inner wall of the tubular organ when the medical marker 100 is placed, to emit fluorescence, making it possible to identify the position of the medical marker 100 from the outside of the tubular organ. However, since the locking portion 150 requires a locking force to attach the medical marker 100 to the inner wall of the tubular organ, if a phosphor is placed on the locking portion 150, it is more preferable to coat the locking portion 150, which is made of metal or the like, with the phosphor.
[0091] (Second Embodiment) A second embodiment of the present invention will now be described. In the following, the descriptions of components similar to those of the first embodiment described above may be simplified or omitted.
[0092] The configuration of the medical marker 200 in the second embodiment of the present invention will be described with reference to Figures 15 to 18. Figure 15 is a perspective view showing the curved state of the locking portion 250 of the medical marker 200 in the second embodiment of the present invention, and Figure 16 is a side view showing the curved state of the locking portion 250 of the medical marker 200 in the second embodiment of the present invention. Figure 17 is a perspective view showing the extended state of the locking portion 250 of the medical marker 200 in the second embodiment of the present invention, and Figure 18 is a side view showing the extended state of the locking portion 250 of the medical marker 200 in the second embodiment of the present invention. Note that in Figures 16 and 18, the cylindrical member 240 is shown as a transparent element.
[0093] The medical marker 200 in the second embodiment is a medical marker 200 that is implanted in a tubular organ in the body, and as shown in Figures 15 to 18, it generally comprises a main body 220 and four locking parts 250 fixed to a part of the distal side of the main body 220. The medical marker 200 shown in Figures 15 to 18 has four locking parts 250, but it may also have two, three, or five or more locking parts 250.
[0094] The main body portion 220 is a member that extends in the longitudinal direction L as a whole. In the second embodiment, the main body portion 220 is made of a base material 230.
[0095] The base material 230 is composed of a cylindrical member extending in the longitudinal direction L. A substantially U-shaped connecting portion 232 is provided on the proximal side of the base material 230. The base material 230 and the connecting portion 232 may be formed integrally. In addition, the base end 251 of the locking portion 250 is fixed to the distal end of the base material 230.
[0096] The cylindrical member 240 is a cylindrical member having a lumen 241 extending in the longitudinal direction L. The cylindrical member 240 is fitted onto the base material 230 and is configured to slide relative to the base material 230 in the longitudinal direction L when fitted onto the base material 230. The central axes of the cylindrical base material 230 and the cylindrical member 240, which extend in the longitudinal direction L, coincide with the longitudinal central axis Ax. The lumen 241 of the cylindrical member 240 is set to a size that allows the base material 230 to be inserted through it. The cylindrical member 240 can be the same as the cylindrical member 140 in the first embodiment described above.
[0097] The locking portion 250 is positioned distal to the medical marker 200 and is made of a deformable material. The locking portion 250 consists of an elongated plate-like member, as shown in Figures 15 to 18, and has elasticity that allows it to be deformed into a curved state and an extended state, as will be described later.
[0098] The base end 251 of the locking portion 250 is fixed to the distal end of the base material 230, which is a part of the distal side of the main body portion 220.
[0099] The medical marker 200 shown in Figures 15 to 18 is equipped with four locking parts 250 connected to the distal end face of the base material 230, but it may be equipped with two or more locking parts 250. Furthermore, it is preferable that the locking parts 250 are arranged at equal intervals along the circumferential direction centered on the longitudinal central axis Ax of the main body 220 and have a shape that is symmetrical with respect to the longitudinal central axis Ax. In the medical marker 200 shown in Figures 15 to 18, the four locking parts 250 are arranged at 90° intervals in the circumferential direction and have a shape that is symmetrical with respect to each other, but it is preferable that, for example, if there are two locking parts 250 they are arranged at 180° intervals, and if there are three locking parts 250 they are arranged at 120° intervals. This makes it possible to support the medical marker 200 in a balanced manner.
[0100] The tip 254 of the locking portion 250 is a free end. As will be described later, when attaching the medical marker 200 to the inner wall of a tubular organ, the locking portion 250 is inserted into the inner wall of the tubular organ from its tip 254. To improve the ease with which the locking portion 250 can penetrate the inner wall of the tubular organ, it is preferable that the tip 254 is sharply formed toward the tip.
[0101] When no external force is acting on the locking portion 250, the locking portion 250 is shaped to be curved (curved state). In the curved state, the locking portion 250 is curved laterally from the base end 251, as shown in Figures 15 and 16, similar to the locking portion 150 in the first embodiment described above, and is positioned so that the tip 254 is located proximal to the base end 251.
[0102] On the other hand, when an external force is applied to the locking portion 250, the locking portion 250 can be deformed into a state that extends in a substantially straight line (extended state). As shown in Figures 17 and 18, the locking portion 250 in the extended state has a shape that extends in the longitudinal direction L toward the distal side from the base end portion 251.
[0103] More specifically, as shown in Figures 15 to 18, the locking portion 250 of the medical marker 200 is configured to include a first curved portion 252 connected to the base portion 251 and a second curved portion 253 connected to the tip of the first curved portion 252, between the base portion 251 and the tip portion 254. The first curved portion 252 is deformable into a curved state in which it is shaped to curve away from the longitudinal central axis Ax from the base portion 251, which is fixed to the distal end of the base material 230, which is a part of the distal side of the main body portion 220, and an extended state in which it extends along the longitudinal direction L. The second curved portion 253 is also deformable into a curved state in which it is shaped to curve closer to the longitudinal central axis Ax of the main body portion 220 from the connection point P where it connects to the first curved portion 252, and an extended state in which it extends along the longitudinal direction L.
[0104] In the medical marker 200 of the second embodiment, the locking portion 250 can be deformed into a curved or extended state by sliding the cylindrical member 240 fitted onto the base material 230 in the longitudinal direction L relative to the base material 230.
[0105] When the cylindrical member 240 is slid proximal, as shown in Figures 15 and 16, the cylindrical member 240 is positioned to fit over the base material 230 which is located proximal to the locking portion 250. At this time, no external force acts on the locking portion 250, and the first curved portion 252 and the second curved portion 253 constituting the locking portion 250 deform into a curved state. Alternatively, for example, the width of the proximal end of the base material 230 may be made larger than the lumen 241 of the cylindrical member 240, preventing the cylindrical member 240 from sliding proximal to a predetermined position. This prevents the cylindrical member 240 from falling out proximal to a predetermined position through the connecting portion 232 and also allows the cylindrical member 240 to be fixed in a predetermined position.
[0106] On the other hand, when the cylindrical member 240 is slid distally, as shown in Figures 17 and 18, the cylindrical member 240 is positioned so as to fit the locking portion 250 onto it. At this time, the locking portion 250 is drawn into the lumen 241 of the cylindrical member 240 in the order of the second curved portion 253 and the first curved portion 252, while contacting the inner circumferential surface of the cylindrical member 240. The first curved portion 252 and the second curved portion 253 constituting the locking portion 250 are pressed from the inner circumferential surface of the cylindrical member 240, extending in the longitudinal direction L and deforming into an elongated state.
[0107] The second curved portion 253, connected to the tip of the first curved portion 252, is shaped to curve in a direction close to the longitudinal central axis Ax, and the tip portion 254 of the locking portion 250 in the curved state is oriented inward (towards the main body portion 220) by the second curved portion 253. Similar to the locking portion 150 in the first embodiment described above, the angle between the direction of the tip portion 254 and the longitudinal central axis Ax in the curved state is preferably greater than 180°, more preferably greater than 225°, and may be greater than 270°. This improves the safety and mounting stability of the medical marker 200.
[0108] In the second embodiment, one or both of the main body portion 220 (substrate 230) and the locking portion 250 constituting the medical marker 200 are arranged on 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 main body portion 220 may be made of phosphor, or part or all of the main body portion 220 may be coated with phosphor. Alternatively, part or all of the locking portion 250 may be made of phosphor, or part or all of the locking portion 250 may be coated with phosphor.
[0109] As described later, when implanting the medical marker 200 in the body, for example, the medical marker 200 can be inserted into the body using the delivery device 2 described later and attached to the inner wall of a tubular organ. By placing a phosphor on the medical marker 200, the phosphor can be attached to the inner wall of a tubular organ, and the fluorescence of the phosphor can be visually observed from the outside of the tubular organ. The phosphor placed on the medical marker 200 in the second embodiment can be the same phosphor as the medical marker 100 in the first embodiment described above.
[0110] The medical marker 200 is attached to the inner wall of a tubular organ by penetrating the locking portion 250 through the inner wall of the tubular organ. As described above, part or all of the locking portion 250 may be made of a phosphor, but it is preferable that the locking portion 250 has sufficient strength to penetrate the inner wall of the tubular organ and maintain its attachment to the inner wall of the tubular organ. Therefore, when a phosphor is placed on the locking portion 250, it is preferable to coat the locking portion 250, which is made of a metal such as nickel-titanium alloy or stainless steel, with the phosphor.
[0111] Furthermore, as described above, a phosphor may be placed on a part of the base material 230, which is the main body 220. In this case, it is preferable to place the phosphor at the distal end of the base material 230, which is located on the distal side of the base material 230 (the side closer to the inner wall of the tubular organ when implanted), so that the phosphor is easily visible from the outside of the tubular organ when the medical marker 200 is attached to the inner wall of the tubular organ.
[0112] In the second embodiment, preferred configurations of the medical marker 200 include, in order to improve the attachment strength to the inner wall of a tubular organ, forming the locking portion 250 from a metal such as nickel-titanium alloy or stainless steel, and then constructing part or all of the base material 230 or cylindrical member 240 with a phosphor, or coating part or all of the locking portion 250 with a phosphor.
[0113] The medical marker 200 in the second embodiment has the same basic structure as the medical marker 100 in the first embodiment, except that the base material 230 is made of a cylindrical member. Therefore, the medical marker 200 in the second embodiment can be implanted in the body in the same manner as the medical marker 100 in the first embodiment using the delivery device 2 shown in Figure 5 described above.
[0114] The connection of the medical marker 200 to the delivery device 2 shown in Figure 5 will be described with reference to Figures 19 and 20. Figure 19 is a partial side view showing the medical marker 200 in an extended state attached to the distal end of the delivery device 2 in a second embodiment of the present invention. Figure 20 is a partial side view showing the medical marker 200 in a curved state using the delivery device 2 in a second embodiment of the present invention. In Figures 19 and 20, the delivery device 2 is drawn with a dashed line and is shown transparently, and the cylindrical member 240 is also shown transparently.
[0115] When delivering the medical marker 200 into the body, the medical marker 200 is attached to the delivery device 2 in an extended state with the cylindrical member 240 positioned distally and the locking portion 250 extended. For example, the connecting portion 232 located on the proximal side of the extended or curved medical marker 200 is positioned so that the connecting hook 21 grips it, and the connecting hook 21 is completely closed. Furthermore, the base portion 27 is slid distally relative to the slider portion 28 to embed the connecting hook 21 into the sheath 22. As a result, as shown in Figure 19, the connecting portion 232 is gripped by the connecting hook 21, and the medical marker 200 can be attached to the distal end of the sheath 22 with the distal end surface of the tip member 24 in contact with the proximal end surface of the cylindrical member 240 of the medical marker 200.
[0116] When attaching the medical marker 200 to the inner wall of a tubular organ, the medical marker 200 is deformed from an extended state to a curved state by the action of the delivery device 2. Specifically, when the base portion 27 is slid proximal to the slider portion 28 while pressing the distal end face of the cylindrical member 240, which is positioned distal to the medical marker 200, against the inner wall of the tubular organ, the connecting hook 21 at the distal end of the drive wire 23 slides distally while the cylindrical member 240 is sandwiched and fixed between the inner wall of the tubular organ and the distal end face of the tip member 24. As a result, the base material 230 and the locking portion 250 connected to the connecting portion 232, which is gripped by the connecting hook 21, move distally to the cylindrical member 240 and are pushed out together, and the locking portion 250 is released from the external force of the cylindrical member 240 and deformed into a curved state, as shown in Figure 20.
[0117] To release the connection of the medical marker 200 to the distal end of the sheath 22 from this state, the base portion 27 is slid proximal to the slider portion 28 while lifting the distal end of the delivery device 2 away from the inner wall of the tubular organ, thereby sliding the sheath 22 proximal to the drive wire 23. This exposes the connecting hook 21 from the distal end of the sheath 22, causing it to spread open and releasing the grip (connection) of the connecting portion 232 by the connecting hook 21, allowing the medical marker 200 to be separated from the delivery device 2.
[0118] Next, the procedure for implanting the medical marker 200 in the second embodiment will be described with reference to Figures 21 to 23. In the following, the procedure for attaching the medical marker 200 near a lesion (tumor 7) on the inner wall of a tubular organ (such as the inner wall of a bile duct) will be described, with appropriate reference to the area near region A in Figure 8 used in the first embodiment described above.
[0119] Figures 21 to 23 are schematic enlarged views of the vicinity of region A in Figure 8, illustrating the first to third steps of the procedure for implanting a medical marker 200 in a tubular organ. For clarity, Figures 21 to 23 show the mucosa 5 and serosa 6 of the tubular organ in cross-section. In Figures 21 and 22, the delivery device 2 is drawn with a dotted line, and the cylindrical member 240 of the medical marker 200 is shown in cross-section. Figures 21 to 23 correspond to Figures 9, 12, and 13, respectively, in the first embodiment.
[0120] Similar to the first embodiment described above, in the second embodiment as well, the distal end of the delivery device 2, to which the extended medical marker 200 is attached (as shown in Figure 19), is advanced through the channel of the endoscope 8, exposing the distal end of the delivery device 2 into the tubular organ.
[0121] In that state, as shown in Figure 21, the distal end of the delivery device 2 is manipulated to press the distal end face of the cylindrical member 240 located distal to the delivery device 2 against the mucous membrane 5 of the inner wall of the tubular organ. Then, while pressing the distal end face of the cylindrical member 240 against the inner wall of the tubular organ, the base portion 27 is slid proximal to the slider portion 28. As a result, the base material 230 and the locking portion 250 are pushed out together by the connecting portion 232, which is grasped by the connecting hook 21, moving distally to the cylindrical member 240, and the tip portion 254 of the locking portion 250 can be inserted into the mucous membrane 5 of the inner wall of the tubular organ.
[0122] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 250, which has been pushed distal to the cylindrical member 240, is released from the external force of the cylindrical member 240 and moves through the mucous membrane 5 of the inner wall of the tubular organ while deforming into a curved state. The tip portion 254 of the locking portion 250 moves back into the tubular organ while spreading laterally within the mucous membrane 5 of the inner wall of the tubular organ, and is exposed again from the inner wall of the tubular organ into the tubular organ.
[0123] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 250 is pushed distal to the cylindrical member 240, and as shown in Figure 22, the locking portion 250 is released from the external force of the cylindrical member 240 and deforms back into its original curved state (as shown in Figure 20). Then, by releasing the connection of the medical marker 200 to the distal end of the sheath 22, the medical marker 200 becomes attached to the inner wall of the tubular organ, as shown in Figure 23. Multiple medical markers 200 may be attached to the inner wall of the tubular organ by repeating the above process. The delivery device 2 described above can also be used when removing a medical marker 200 that has been implanted in the body from the inner wall of a tubular organ.
[0124] As described above, the medical marker 200 implanted in the body has a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light, arranged on at least one of the main body portion 220 (substrate 230) and the locking portion 250. The medical marker 200 is implanted in the body attached to the inner wall of a tubular organ, and, similar to the medical marker 100 in the first embodiment described above, the fluorescence emitted by the phosphor constituting the medical marker 200 can be visually observed from outside the tubular organ.
[0125] Furthermore, the medical marker 200 can be attached to the inner wall of a tubular organ by penetrating the locking portion 250 through the inner wall of the tubular organ. The locking portion 250 is bent to a curved shape, and as it penetrates the inner wall of the tubular organ, it expands outward while returning to the inside of the tubular organ, allowing the medical marker 200 to be stably attached to the inner wall of the tubular organ. In addition, since the phosphor placed on the medical marker 200 can be positioned so as to press against the inner wall of the tubular organ, the visibility of the phosphor from the outside of the tubular organ can be improved.
[0126] The locking portion 250 is configured to include a second curved portion 253 which is bent in a direction close to the longitudinal central axis Ax, and the tip portion 254 of the locking portion 250 in the curved state can be directed inward (towards the main body portion 220) by the second curved portion 253. This prevents the tip portion 254 of the medical marker 200 when attached to the inner wall of a tubular organ from pointing sideways, thereby reducing the risk of damage to the inner wall of the tubular organ by the tip portion 254, and also improves the locking force to the inner wall of the tubular organ by the locking portion 250.
[0127] It is preferable that the phosphor of the medical marker 200 attached to the inner wall of a tubular organ be positioned so that it is clearly visible from the outside of the tubular organ. For example, it is preferable to make the distal end or the entire cylindrical base material 230 out of phosphor, or to coat the distal end or the entire base material 230 with phosphor, or to make the distal end or the entire cylindrical member 240 out of phosphor, or to coat the distal end or the entire cylindrical member 240 with phosphor. This allows the base material 230 or cylindrical member 240, which is positioned to be pressed against the inner wall of the tubular organ when the medical marker 200 is placed, to emit fluorescence, making it possible to identify the position of the medical marker 200 from the outside of the tubular organ. Furthermore, it is preferable, for example, to make part or all of the locking portion 250 out of phosphor, or to coat part or all of the locking portion 250 with phosphor. This allows the locking portion 250, which penetrates the inner wall of the tubular organ when the medical marker 200 is placed, to emit fluorescence, making it possible to identify the position of the medical marker 200 from the outside of the tubular organ. However, since the locking portion 250 requires a locking force to attach the medical marker 200 to the inner wall of the tubular organ, it is more preferable to coat the locking portion 250, which is made of metal or the like, with phosphor when placing phosphor in the locking portion 250.
[0128] (Third embodiment) A third embodiment of the present invention will now be described. In the following, components similar to those in the first embodiment described above will be denoted by the same reference numerals, and their descriptions may be simplified or omitted.
[0129] The configuration of the medical marker 300 in the third embodiment of the present invention will be described with reference to Figures 24 and 25. Figure 24 is a perspective view showing the curved state of the locking portion 150 of the medical marker 300 in the third embodiment of the present invention. Figure 25 is a perspective view showing the extended state of the locking portion 150 of the medical marker 300 in the third embodiment of the present invention.
[0130] The medical marker 300 in the third embodiment is a medical marker 300 that is implanted in a tubular organ in the body, and as shown in Figures 24 and 25, it generally comprises a main body 120 and two locking parts 150 fixed to a part of the distal side of the main body 120.
[0131] However, the medical marker 100 in the first embodiment described above has a main body 120 composed of a base material 130 and a cylindrical member 140, whereas the medical marker 300 in the third embodiment differs in that the main body 120 is composed of a base material 130 and does not have a cylindrical member 140. As a result, the medical marker 300 in the third embodiment can have fewer parts than the medical marker 100 in the first embodiment, and since there is no need to slide the cylindrical member 140 against the base material 130, the longitudinal length of the base material 130 can be shortened. As for other components, the medical marker 300 in the third embodiment can use the same components as the medical marker 100 in the first embodiment described above, and will not be explained here.
[0132] In the third embodiment, one or both of the main body portion 120 and the locking portion 150 constituting the medical marker 300 are arranged on 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 main body portion 120 may be made of phosphor, or part or all of the main body portion 120 may be coated with phosphor. Alternatively, part or all of the locking portion 150 may be made of phosphor, or part or all of the locking portion 150 may be coated with phosphor.
[0133] As described later, when implanting the medical marker 300 in the body, for example, the medical marker 300 can be inserted into the body using the delivery device 2 described later and attached to the inner wall of a tubular organ. By placing a phosphor on the medical marker 300, the phosphor can be attached to the inner wall of a tubular organ, and the fluorescence of the phosphor can be visually observed from the outside of the tubular organ. The phosphor placed on the medical marker 300 in the third embodiment can be the same phosphor as the medical marker 100 in the first embodiment described above.
[0134] The medical marker 300 is attached to the inner wall of a tubular organ by piercing the locking portion 150 through the inner wall of the tubular organ. As described above, part or all of the locking portion 150 may be made of a phosphor, but it is preferable that the locking portion 150 has sufficient strength to pierce the inner wall of the tubular organ and maintain its attachment to the inner wall of the tubular organ. Therefore, when a phosphor is placed on the locking portion 150, it is preferable to coat the locking portion 150, which is made of a metal such as nickel-titanium alloy or stainless steel, with the phosphor.
[0135] Furthermore, as described above, a phosphor may be placed on a part of the main body 120. In this case, it is preferable to place the phosphor on the arm portion 131 located distal to the main body 120 (closer to the inner wall of the tubular organ when implanted) so that the phosphor is easily visible from the outside of the tubular organ when the medical marker 300 is attached to the inner wall of the tubular organ.
[0136] In the third embodiment, a preferred configuration of the medical marker 300 is to form the base material 130 and the locking portion 150 integrally from a metal such as nickel-titanium alloy or stainless steel, and then coat part or all of the locking portion 150 with a phosphor, in order to improve the attachment strength to the inner wall of a tubular organ.
[0137] The medical marker 300 in the third embodiment can also be implanted in the body using, for example, the delivery device 2 shown in Figure 5.
[0138] The connection of the medical marker 300 to the delivery device 2 shown in Figure 5 will be described with reference to Figures 26 and 27. Figure 26 is a partial side view showing the medical marker 300 in an extended state attached to the distal end of the delivery device 2 in a third embodiment of the present invention. Figure 27 is a partial side view showing the medical marker 300 in a curved state using the delivery device 2 in a third embodiment of the present invention. In Figures 26 and 27, the delivery device 2 is drawn with a dashed line and is shown transparently.
[0139] When the medical marker 300 is delivered into the body, the medical marker 300 is attached to the delivery device 2 in an extended state with the locking portion 150 extended. For example, the connecting portion 132 located on the proximal side of the extended or curved medical marker 300 is positioned so that the connecting hook 21 grips it, and the connecting hook 21 is completely closed. Furthermore, the base portion 27 is slid distally relative to the slider portion 28 to embed the connecting hook 21 into the sheath 22. As a result, as shown in Figure 26, the medical marker 300 can be attached so that it is housed in the tip member 24 of the sheath 22 and the sheath 22 while the connecting portion 132 is gripped by the connecting hook 21. At this time, the locking portion 150 is pulled into the tip member 24 while contacting the inner circumferential surface of the tip member 24, and the first curved portion 152 and the second curved portion 153 constituting the locking portion 150 are pressed from the inner circumferential surface of the tip member 24, extending in the longitudinal direction L and deforming into an extended state.
[0140] When the medical marker 300 is attached to the inner wall of a tubular organ, the medical marker 300 is deformed from an extended state to a curved state by the action of the delivery device 2. Specifically, when the base portion 27 is slid proximal to the slider portion 28, the connecting hook 21 at the distal end of the drive wire 23 slides distally. As a result, the arm portion 131 and the locking portion 150 connected to the connecting portion 232, which is gripped by the connecting hook 21, move distally relative to the tip member 24 and the sheath 22 and are pushed out together, and the locking portion 150 is released from the external force of the tip member 24 and deformed into a curved state, as shown in Figure 27.
[0141] To release the connection of the medical marker 300 to the distal end of the sheath 22 from this state, the base portion 27 is slid proximal to the slider portion 28 while lifting the distal end of the delivery device 2 away from the inner wall of the tubular organ, thereby sliding the sheath 22 proximal to the drive wire 23. This exposes the connecting hook 21 from the distal end of the sheath 22, causing it to spread open and releasing the grip (connection) of the connecting portion 132 by the connecting hook 21, allowing the medical marker 300 to be separated from the delivery device 2.
[0142] Next, the procedure for implanting the medical marker 300 in the third embodiment will be described with reference to Figures 28 to 30. In the following, the procedure for attaching the medical marker 300 near a lesion (tumor 7) on the inner wall of a tubular organ (such as the inner wall of a bile duct) will be described, with appropriate reference to the area near region A in Figure 8 used in the first embodiment described above.
[0143] Figures 28 to 30 are schematic enlarged views of the vicinity of region A in Figure 8, illustrating the first to third steps of the procedure for implanting a medical marker 300 in a tubular organ. For clarity, Figures 28 to 30 show the mucosa 5 and serosa 6 of the tubular organ in cross-section. In Figures 28 and 29, the delivery device 2 is depicted with a dotted line. Figures 28 to 30 correspond to Figures 9, 12, and 13, respectively, in the first embodiment.
[0144] Similar to the first embodiment described above, in the third embodiment as well, the distal end of the delivery device 2, to which the extended medical marker 300 is attached (as shown in Figure 26), is advanced through the channel of the endoscope 8, exposing the distal end of the delivery device 2 into the tubular organ.
[0145] In that state, as shown in Figure 28, the distal end of the delivery device 2 is manipulated to press the distal end face of the tip member 24 of the delivery device 2 against the mucosa 5 of the inner wall of the tubular organ. Then, while pressing the distal end face of the tip member 24 against the inner wall of the tubular organ, the base portion 27 is slid proximal to the slider portion 28. As a result, the arm portion 131 and the locking portion 150 connected to the connecting portion 132 grasped by the connecting hook 21 move distally relative to the tip member 24 and the sheath 22 and are pushed out together, allowing the tip portion 154 of the locking portion 150 to penetrate into the mucosa 5 of the inner wall of the tubular organ.
[0146] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 150, which has been pushed distal to the tip member 24, is released from the external force of the tip member 24 and moves through the mucous membrane 5 of the inner wall of the tubular organ while deforming into a curved state. The tip portion 154 of the locking portion 150 moves back into the tubular organ while spreading laterally within the mucous membrane 5 of the inner wall of the tubular organ, and is exposed again from the inner wall of the tubular organ into the tubular organ.
[0147] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 150 is pushed distal to the tip member 24, and as shown in Figure 29, the locking portion 150 is released from the external force of the tip member 24 and deforms back into its original curved state (as shown in Figure 27). Then, by releasing the connection of the medical marker 300 to the distal end of the sheath 22, the medical marker 300 becomes attached to the inner wall of the tubular organ, as shown in Figure 30. Multiple medical markers 300 may be attached to the inner wall of the tubular organ by repeating the above process. The delivery device 2 described above can also be used when removing a medical marker 300 that has been implanted in the body from the inner wall of a tubular organ.
[0148] As described above, the medical marker 300 implanted in the body has a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light, arranged on at least one of the main body portion 120 (substrate 130) and the locking portion 150. The medical marker 300 is implanted in the body attached to the inner wall of a tubular organ, and, similar to the medical marker 100 in the first embodiment described above, the fluorescence emitted by the phosphor constituting the medical marker 300 can be visually observed from outside the tubular organ.
[0149] Furthermore, the medical marker 300 can be attached to the inner wall of a tubular organ by penetrating the locking portion 150 through the inner wall of the tubular organ. The locking portion 150 is bent to a curved shape, and as it penetrates the inner wall of the tubular organ, it expands outward while returning to the inside of the tubular organ, allowing the medical marker 300 to be stably attached to the inner wall of the tubular organ. In addition, since the phosphor placed on the medical marker 300 can be positioned so as to press against the inner wall of the tubular organ, the visibility of the phosphor from the outside of the tubular organ can be improved.
[0150] The locking portion 150 is configured to include a second curved portion 153 that is curved in a direction close to the longitudinal central axis Ax, and the tip portion 154 of the locking portion 150 in the curved state can be directed inward (towards the main body portion 120) by the second curved portion 153. This prevents the tip portion 154 of the medical marker 300, when attached to the inner wall of a tubular organ, from pointing sideways, thereby reducing the risk of the tip portion 154 damaging the inner wall of the tubular organ. Even if the medical marker 300 detaches from the inner wall of the tubular organ and becomes loose inside the tubular organ, the risk of the tip portion 154 damaging the inner wall of the tubular organ can be reduced, and the locking force to the inner wall of the tubular organ can be improved by the locking portion 150.
[0151] It is preferable that the phosphor of the medical marker 300 attached to the inner wall of a tubular organ be positioned so that it is clearly visible from the outside of the tubular organ. For example, it is preferable to make part or all of the locking portion 150 out of phosphor, or to coat part or all of the locking portion 150 with phosphor. This allows the locking portion 150, which penetrates the inner wall of the tubular organ when the medical marker 300 is placed, to emit fluorescence, making it possible to identify the position of the medical marker 300 from the outside of the tubular organ. However, since the locking portion 150 requires a locking force to attach the medical marker 300 to the inner wall of the tubular organ, it is more preferable to coat the locking portion 150, which is made of metal or the like, with phosphor when placing phosphor on the locking portion 150.
[0152] (Fourth Embodiment) A fourth embodiment of the present invention will now be described. In the following description, components similar to those in the second embodiment described above will be denoted by the same reference numerals, and their descriptions may be simplified or omitted.
[0153] The configuration of the medical marker 400 in the fourth embodiment of the present invention will be described with reference to Figures 31 and 32. Figure 31 is a perspective view showing the curved state of the locking portion 250 of the medical marker 400 in the fourth embodiment of the present invention. Figure 32 is a perspective view showing the extended state of the locking portion 250 of the medical marker 400 in the fourth embodiment of the present invention.
[0154] The medical marker 400 in the fourth embodiment is a medical marker 400 that is implanted in a tubular organ in the body, and as shown in Figures 31 and 32, it generally comprises a main body 220 and four locking parts 250 fixed to a part of the distal side of the main body 220.
[0155] However, the medical marker 200 in the second embodiment described above has a main body 220 composed of a base material 230 and a cylindrical member 240, whereas the medical marker 400 in the fourth embodiment differs in that the main body 220 is composed of a base material 230 and does not have a cylindrical member 240. As a result, the medical marker 400 in the fourth embodiment can have fewer parts than the medical marker 200 in the second embodiment, and since there is no need to slide the cylindrical member 240 against the base material 230, the longitudinal length of the base material 230 can be shortened. As for other components, the medical marker 400 in the fourth embodiment can use the same components as the medical marker 200 in the second embodiment described above, and will not be explained here.
[0156] In the fourth embodiment, one or both of the main body 220 and the locking portion 250 constituting the medical marker 400 are arranged on 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 main body 220 may be made of phosphor, or part or all of the main body 220 may be coated with phosphor. Alternatively, part or all of the locking portion 250 may be made of phosphor, or part or all of the locking portion 250 may be coated with phosphor.
[0157] As described later, when implanting the medical marker 400 in the body, for example, the medical marker 400 can be inserted into the body using the delivery device 2 described later and attached to the inner wall of a tubular organ. By placing a phosphor on the medical marker 400, the phosphor can be attached to the inner wall of a tubular organ, and the fluorescence of the phosphor can be visually observed from the outside of the tubular organ. The phosphor placed on the medical marker 400 in the fourth embodiment can be the same phosphor as the medical marker 100 in the first embodiment described above.
[0158] The medical marker 400 is attached to the inner wall of a tubular organ by penetrating the locking portion 250 through the inner wall of the tubular organ. As described above, part or all of the locking portion 250 may be made of a phosphor, but it is preferable that the locking portion 250 has sufficient strength to penetrate the inner wall of the tubular organ and maintain its attachment to the inner wall of the tubular organ. Therefore, when a phosphor is placed on the locking portion 250, it is preferable to coat the locking portion 250, which is made of a metal such as nickel-titanium alloy or stainless steel, with the phosphor.
[0159] Furthermore, as described above, a phosphor may be placed on a part of the main body 220. In this case, it is preferable to place the phosphor at the distal end of the base material 230, which is located on the distal side of the main body 220 (the side closer to the inner wall of the tubular organ when implanted), so that the phosphor is easily visible from the outside of the tubular organ when the medical marker 400 is attached to the inner wall of the tubular organ.
[0160] In the fourth embodiment, preferred configurations of the medical marker 400 include coating part or all of the base material 230 with a phosphor to improve the attachment strength to the inner wall of a tubular organ, or integrally forming the locking portion 250 from a metal such as nickel-titanium alloy or stainless steel, and then coating part or all of the locking portion 250 with a phosphor.
[0161] The medical marker 400 in the fourth embodiment can also be implanted in the body using, for example, the delivery device 2 shown in Figure 5.
[0162] The connection of the medical marker 400 to the delivery device 2 shown in Figure 5 will be described with reference to Figures 33 and 34. Figure 33 is a partial side view showing the medical marker 400 in an extended state attached to the distal end of the delivery device 2 in a fourth embodiment of the present invention. Figure 34 is a partial side view showing the medical marker 400 in a curved state using the delivery device 2 in a fourth embodiment of the present invention. In Figures 33 and 34, the delivery device 2 is drawn with a dashed line and is shown transparently.
[0163] When the medical marker 400 is delivered into the body, the medical marker 400 is attached to the delivery device 2 in an extended state with the locking portion 250 extended. For example, the connecting portion 232 located on the proximal side of the extended or curved medical marker 400 is positioned so that the connecting hook 21 grips it, and the connecting hook 21 is completely closed. Furthermore, the base portion 27 is slid distally relative to the slider portion 28 to embed the connecting hook 21 into the sheath 22. As a result, as shown in Figure 33, the medical marker 400 can be attached so that it is housed in the tip member 24 and the sheath 22 while the connecting portion 232 is gripped by the connecting hook 21. At this time, the locking portion 250 is pulled into the tip member 24 while contacting the inner circumferential surface of the tip member 24, and the first curved portion 252 and the second curved portion 253 constituting the locking portion 250 are pressed from the inner circumferential surface of the tip member 24, extending in the longitudinal direction L and deforming into an extended state.
[0164] When the medical marker 400 is attached to the inner wall of a tubular organ, the medical marker 400 is deformed from an extended state to a curved state by the action of the delivery device 2. Specifically, when the base portion 27 is slid proximal to the slider portion 28, the connecting hook 21 at the distal end of the drive wire 23 slides distally. As a result, the base material 230 and the locking portion 250 connected to the connecting portion 232, which is gripped by the connecting hook 21, move distally relative to the tip member 24 and the sheath 22 and are pushed out together. The locking portion 250 is then released from the external force of the tip member 24 and deformed into a curved state, as shown in Figure 34.
[0165] To release the connection of the medical marker 400 to the distal end of the sheath 22 from this state, the base portion 27 is slid proximal to the slider portion 28 while the distal end of the delivery device 2 is lifted away from the inner wall of the tubular organ, causing the sheath 22 to slide proximal to the drive wire 23. This exposes the connecting hook 21 from the distal end of the sheath 22, causing it to spread open and releasing the grip (connection) of the connecting portion 232 by the connecting hook 21, allowing the medical marker 400 to be separated from the delivery device 2.
[0166] Next, with reference to Figures 35 to 37, the procedure for implanting the medical marker 400 in the fourth embodiment will be described. In the following, the procedure for attaching the medical marker 400 near a lesion (tumor 7) on the inner wall of a tubular organ (such as the inner wall of a bile duct) will be described, with appropriate reference to the area near region A in Figure 8 used in the first embodiment described above.
[0167] Figures 35 to 37 are schematic enlarged views of the vicinity of region A in Figure 8, illustrating the first to third steps of the procedure for implanting a medical marker 400 in a tubular organ. For clarity, Figures 35 to 37 show the mucosa 5 and serosa 6 of the tubular organ in cross-section. In Figures 35 and 36, the delivery device 2 is depicted with a dotted line. Figures 35 to 37 correspond to Figures 9, 12, and 13, respectively, in the first embodiment.
[0168] Similar to the second embodiment described above, in the fourth embodiment as well, the distal end of the delivery device 2 (as shown in Figure 33), to which the extended medical marker 400 is attached, is advanced through the channel of the endoscope 8, exposing the distal end of the delivery device 2 into the tubular organ.
[0169] In that state, as shown in Figure 35, the distal end of the delivery device 2 is manipulated to press the distal end face of the tip member 24 of the delivery device 2 against the mucosa 5 of the inner wall of the tubular organ. Then, while pressing the distal end face of the tip member 24 against the inner wall of the tubular organ, the base portion 27 is slid proximal to the slider portion 28. As a result, the base material 230 and the locking portion 250 connected to the connecting portion 232 grasped by the connecting hook 21 move distally relative to the tip member 24 and the sheath 22 and are pushed out together, allowing the tip portion 254 of the locking portion 250 to penetrate into the mucosa 5 of the inner wall of the tubular organ.
[0170] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 250, which has been pushed distal to the tip member 24, is released from the external force of the tip member 24 and moves through the mucous membrane 5 of the inner wall of the tubular organ while deforming into a curved state. The tip portion 254 of the locking portion 250 moves back into the tubular organ while spreading laterally within the mucous membrane 5 of the inner wall of the tubular organ, and is exposed again from the inner wall of the tubular organ into the tubular organ.
[0171] When the base portion 27 is further slid proximal to the slider portion 28, the locking portion 250 is pushed distal to the tip member 24, and as shown in Figure 36, the locking portion 250 is released from the external force of the tip member 24 and deforms back into its original curved state (as shown in Figure 34). Then, by releasing the connection of the sheath 22 of the medical marker 400 to the distal end, the medical marker 400 becomes attached to the inner wall of the tubular organ, as shown in Figure 37. Multiple medical markers 400 may be attached to the inner wall of the tubular organ by repeating the above process. The delivery device 2 described above can also be used when removing a medical marker 400 that has been implanted in the body from the inner wall of a tubular organ.
[0172] As described above, the medical marker 400 implanted in the body has a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light, arranged on at least one of the main body portion 220 (substrate 230) and the locking portion 250. The medical marker 400 is implanted in the body attached to the inner wall of a tubular organ, and, similar to the medical marker 200 in the second embodiment described above, the fluorescence emitted by the phosphor constituting the medical marker 400 can be visually observed from outside the tubular organ.
[0173] Furthermore, the medical marker 400 can be attached to the inner wall of a tubular organ by penetrating the locking portion 250 through the inner wall of the tubular organ. The locking portion 250 is bent into a curved shape and penetrates the inner wall of the tubular organ in a way that it expands outward inside the tubular organ and then returns to the inside of the tubular organ, so that the medical marker 400 can be stably attached to the inner wall of the tubular organ. In addition, the phosphor placed on the medical marker 400 can be positioned so as to press against the inner wall of the tubular organ, thereby improving the visibility of the phosphor from the outside of the tubular organ.
[0174] The locking portion 250 is configured to include a second curved portion 253 which is curved in a direction close to the longitudinal central axis Ax, and the tip portion 254 of the locking portion 250 in the curved state can be directed inward (towards the main body portion 220) by the second curved portion 253. This prevents the tip portion 254 of the medical marker 400, when attached to the inner wall of a tubular organ, from facing sideways, thereby reducing the risk of the tip portion 254 damaging the inner wall of the tubular organ. Even if the medical marker 400 detaches from the inner wall of the tubular organ and becomes loose inside the tubular organ, the risk of the tip portion 254 damaging the inner wall of the tubular organ can be reduced, and the locking portion 250 can improve the locking force to the inner wall of the tubular organ.
[0175] It is preferable that the phosphor of the medical marker 400 attached to the inner wall of a tubular organ be positioned so that it is clearly visible from the outside of the tubular organ. For example, it is preferable to make part or all of the locking portion 250 out of phosphor, or to coat part or all of the locking portion 250 with phosphor. This allows the locking portion 250, which penetrates the inner wall of the tubular organ when the medical marker 400 is placed, to emit fluorescence, making it possible to identify the position of the medical marker 400 from the outside of the tubular organ. However, since the locking portion 250 requires a locking force to attach the medical marker 400 to the inner wall of the tubular organ, it is more preferable to coat the locking portion 250, which is made of metal or the like, with phosphor when placing phosphor on the locking portion 250.
[0176] The following describes the effects of the medical markers 100, 200, 300, and 400 in the first to fourth embodiments described above.
[0177] The medical markers 100, 200, 300, and 400 in the first to fourth embodiments described above are medical markers 100, 200, 300, and 400 that are implanted in tubular organs within the body, and each comprises a main body portion 120, 220 extending in the longitudinal direction L, and two or more locking portions 150, 250 that extend from proximal ends 151, 251 fixed to a part of the distal side of the main body portion 120, 220 to tip portions 154, 254. The locking portions 150, 250 are configured to be deformable into a curved state in which they are curved laterally from the proximal ends 151, 251 so that the tip portions 154, 254 are positioned proximal to the proximal ends 151, 251, and an extended state in which they extend in the longitudinal direction L from the proximal ends 151, 251. The main body parts 120, 220 or the locking parts 150, 250 are arranged with a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range when irradiated with excitation light.
[0178] According to the above configuration, the two or more locking portions 150, 250 of the medical markers 100, 200, 300, and 400 are each configured to be deformable into a curved state in which they are curved laterally from the base ends 151, 251 so that the tip portions 154, 254 are positioned proximal to the base ends 151, 251, and an extended state in which they extend in the longitudinal direction L from the base ends 151, 251.
[0179] This allows the locking portions 150 and 250 to be inserted into the inner wall of a tubular organ by being extended and thrusting them in from approximately perpendicular to the inner wall of the tubular organ, thereby enabling smooth attachment to the inner wall of the tubular organ. Furthermore, the locking portions 150 and 250 are bent into a curved state, and as they penetrate the inner wall of the tubular organ, they expand outward while returning to the inside of the tubular organ, allowing for stable attachment of the medical markers 100, 200, 300, and 400 to the inner wall of the tubular organ. This provides medical markers 100, 200, 300, and 400 with excellent attachment stability and an improved period of indwelling.
[0180] Furthermore, since phosphors are arranged on the main body parts 120, 220 and locking parts 150, 250 that constitute the medical markers 100, 200, 300, and 400, the phosphors can be positioned near the inner wall of the tubular organ by attaching the medical markers 100, 200, 300, and 400 to the inner wall of the tubular organ. This makes it possible to identify the location of the medical markers 100, 200, 300, and 400 by visually observing the fluorescence emitted by the phosphors, thereby providing medical markers 100, 200, 300, and 400 with excellent visibility from the outside of the tubular organ.
[0181] In the first to fourth embodiments described above, the medical markers 100, 200, 300, and 400 may be configured such that the locking portions 150 and 250 have first curved portions 152 and 252 that are deformable between a curved state in which the base ends 151 and 251 fixed to a part of the distal side of the main body portions 120 and 220 are curved away from the longitudinal central axis Ax of the main body portions 120 and 220, and an extended state that extends along the longitudinal direction L; and second curved portions 153 and 253 that are deformable between a curved state in which the connection point with the first curved portions 152 and 252 is curved in which the base ends 151 and 251 are curved away from the longitudinal central axis Ax of the main body portions 120 and 220, and an extended state that extends along the longitudinal direction L.
[0182] According to the above configuration, the first curved portions 152 and 252 are shaped to curve in a direction away from the longitudinal central axis Ax of the main body portions 120 and 220. This allows the locking portions 150 and 250 to penetrate the inner wall of a tubular organ, while the first curved portions 152 and 252 can be made to penetrate the inner wall of the tubular organ in a way that they spread outward while returning to the inside of the tubular organ.
[0183] Furthermore, the second curved sections 153 and 253 connected to the first curved sections 152 and 252 are bent to curve in a direction close to the longitudinal central axis Ax of the main body sections 120 and 220. As a result, the tips 154 and 254 of the locking sections 150 and 250 in the curved state are directed inward (towards the main body sections 120 and 220) by the second curved sections 153 and 253. Therefore, even if the medical markers 100, 200, 300, and 400 detach from the inner wall of the tubular organ and become loose inside the tubular organ, the risk of damage to the inner wall of the tubular organ by the tips 154 and 254 can be reduced. In addition, the safety of the medical markers 100, 200, 300, and 400 can be improved, as can the mounting stability.
[0184] In the first and second embodiments described above, the medical markers 100 and 200 are composed of a main body portion 120 and 220 which consists of a base material 130 and 230 that fixes the base ends 151 and 251 of the locking portions 150 and 250, and a cylindrical member 140 and 240 that is fitted onto the base material 130 and 230 and is slidable in the longitudinal direction L relative to the base material 130 and 230. When the cylindrical member 140 and 240 slides proximal to the base material 130 and 230, the first curve The curved portions 152, 252 and the second curved portions 153, 253 may be exposed to the outside from the distal ends of the cylindrical members 140, 240 and be in a curved state, and when the cylindrical members 140, 240 slide distally relative to the base material 130, 230, the first curved portions 152, 252 and the second curved portions 153, 253 may be drawn into the lumen 141, 241 of the cylindrical members 140, 240 from the distal ends and be in an extended state.
[0185] According to the above configuration, by sliding the cylindrical members 140 and 240 against the base materials 130 and 230, the first curved portions 152 and 252 and the second curved portions 153 and 253 constituting the locking portions 150 and 250 can be deformed, and the first curved portions 152 and 252 and the second curved portions 153 and 253 can be inserted into the inner wall of a tubular organ in an extended state, and then deformed into a curved state so as to return to the inside of the tubular organ, thereby attaching them to the inner wall of the tubular organ.
[0186] The medical markers 100 and 300 in the first and third embodiments described above include a base material 130 comprising two or more arm portions 131 extending in the longitudinal direction L, with their respective proximal ends connected, and the base end 151 of a locking portion 150 may be fixed to the distal end of each of the two or more arm portions 131.
[0187] According to the above configuration, the base material 130 is made up of an arm portion 131 extending in the longitudinal direction L, and a locking portion 150 is provided at the distal end of the arm portion 131, thereby realizing a simple configuration in which the arm portion 131 and the locking portion 150 that constitute the main body portion 120 are integrated.
[0188] In the first and second embodiments described above, the medical markers 100 and 200 may be configured such that part or all of the cylindrical member 140 contains a phosphor.
[0189] With the above configuration, when the medical markers 100 and 200 are attached to the inner wall of a tubular organ, the cylindrical member 140 positioned near the inner wall surface of the tubular organ emits fluorescence, making the fluorescence visible from the outside of the tubular organ. Furthermore, it becomes possible to select a metal or other material for the locking portion 150 to improve the locking function, thereby further improving the mounting stability of the medical markers 100 and 200.
[0190] In the first to fourth embodiments described above, the medical markers 100, 200, 300, and 400 may have a phosphor coating on part or all of the locking portion 150 and 250.
[0191] According to the above configuration, the locking portions 150 and 250 of the medical markers 100, 200, 300, and 400 attached to the inner wall of the tubular organ emit fluorescence, allowing the fluorescence to be visually observed from the outside of the tubular organ. Furthermore, it becomes possible to select metals or other materials that improve the locking function as the material for the locking portions 150 and 250, thereby further improving the mounting stability of the medical markers 100, 200, 300, and 400.
[0192] In the first to fourth embodiments described above, the medical markers 100, 200, 300, and 400 may have locking portions 150 and 250 arranged at equal intervals along the circumferential direction of the longitudinal central axis Ax of the main body portions 120 and 220.
[0193] According to the above configuration, medical markers 100, 200, 300, and 400 can be attached to the inner wall of a tubular organ at two or more isotropically arranged locking positions, thereby further improving the attachment stability of the medical markers 100, 200, 300, and 400.
[0194] In the first to fourth embodiments described above, the medical markers 100, 200, 300, and 400 may have their tip portions 154 and 254 formed to be sharp toward the tip.
[0195] According to the above configuration, the penetration of the locking portions 150 and 250 into the inner wall of the tubular organ can be further improved.
[0196] The embodiments described above are provided to facilitate understanding of the present invention and do not limit it. The components disclosed in the embodiments described above are intended to include all design modifications and equivalents that fall within the technical scope of the present invention. Furthermore, configurations obtained by appropriately combining the components described in each embodiment are also included in the present invention. [Explanation of Symbols]
[0197] 2 Delivery devices 5 Mucosa 6 Serosa 7. Tumors 8 Endoscopes 21 Connecting Hooks 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 section 28 Slider section 29 locking screws 100, 200, 300, 400 Medical Markers 120, 220 Main body 130, 230 base material 131 Arm section (base material) 132, 232 connection part 140, 240 cylindrical members 141, 241 lumen 150, 250 Locking part 151, 251 proximal end 152, 252 First curved section 153, 253 Second curved section 154, 254 Tip Ax Longitudinal central axis L Longitudinal direction P connection point
Claims
1. A medical marker that is implanted in a tubular organ within the body, It comprises a main body portion extending in the longitudinal direction, and two or more locking portions extending from a base end fixed to a part of the distal side of the main body portion to a tip end, The locking portion is configured to be deformable into a curved state in which it is curved laterally from the base end so that the tip is positioned proximal to the base end, and an extended state in which it extends longitudinally from the base end. A medical marker characterized in that a phosphor containing a fluorescent dye that emits fluorescence in a predetermined wavelength range upon irradiation with excitation light is arranged in the main body or the locking portion.
2. The aforementioned locking portion, A first curved portion, which is deformable into a curved state in which the base end fixed to a part of the distal side of the main body is bent in a direction away from the longitudinal central axis of the main body, and an extended state in which it extends along the longitudinal direction, The medical marker according to claim 1, characterized in that it has a second curved portion that can be deformed into a curved state, which is shaped to curve in a direction approaching the longitudinal central axis of the main body from the connection point with the first curved portion, and an extended state that extends along the longitudinal direction.
3. The main body is composed of a base material that fixes the base end of the locking portion, and a cylindrical member that is fitted onto the base material and is slidable in the longitudinal direction relative to the base material. The medical marker according to claim 2, characterized in that when the cylindrical member slides proximal to the base material, the first curved portion and the second curved portion are exposed to the outside from the distal end of the cylindrical member and become curved, and when the cylindrical member slides distal to the base material, the first curved portion and the second curved portion are drawn into the lumen of the cylindrical member from the distal end of the cylindrical member and become extended.
4. The base material comprises two or more arm portions extending in the longitudinal direction, with their respective proximal ends connected, The medical marker according to claim 3, characterized in that the base end of the locking portion is fixed to each of the distal ends of the two or more arm portions.
5. The medical marker according to claim 3 or 4, characterized in that part or all of the cylindrical member is composed of the phosphor.
6. The medical marker according to any one of claims 1 to 4, characterized in that part or all of the locking portion is coated with the phosphor.
7. The medical marker according to any one of claims 1 to 4, characterized in that the locking portions are arranged at equal intervals along the circumferential direction of the longitudinal central axis of the main body.
8. The medical marker according to any one of claims 1 to 4, characterized in that the tip portion is formed to be sharp toward the tip side.
Citation Information
Patent Citations
Medical marker
JP2021069801A