In vivo indwelling device

Abstract

To provide an in vivo indwelling device capable of observing a biological lumen and irradiating the biological lumen with light.SOLUTION: An in vivo indwelling device 1 comprises a tube 10. The tube 10 has, in the extending direction of the tube 10, a first section 21, a second section 22, and a third section 23 located between the first section 21 and the second section 22. In the third section 23, the tube 10 has a portion with higher light transmittance than the tube 10 in at least one of the first section 21 and the second section 22.SELECTED DRAWING: Figure 2

Description

[Technical Field]

[0001] The present invention relates to an in-vivo indwelling device to be placed in a body lumen such as the trachea, digestive tract, ureter, or cervical canal. [Background technology]

[0002] Living lumen such as blood vessels or digestive tracts such as the bile duct and pancreatic duct may become narrowed or obstructed for various reasons. For example, when a bile duct is obstructed by a gallstone or tumor, bile may stagnate in the bile duct, potentially causing bacterial infection. Bacterial infection of bile can lead to cholangitis, and if bacteria-containing bile passes through the liver and enters the bloodstream, it may cause sepsis. In such cases, a procedure to drain bile from the bile duct is necessary. A known method for treating various diseases caused by narrowing or obstruction of a living lumen involves placing a tubular stent at the narrowed or obstructed site and expanding the narrowed or obstructed site from the inside, thereby widening the living lumen.

[0003] For example, when a stricture or blockage occurs in the bile duct, a bile duct tube stent is delivered to the stricture or blockage site. The delivered tube stent is placed at the stricture or blockage site and pushes open the stricture or blockage from the inside. By placing the tube stent, the inner diameter of the bile duct at the stricture or blockage site is expanded, improving the stricture or blockage. As a result, bile can be drained from the bile duct to the duodenum, making it possible to treat various diseases caused by stricture or blockage of the bile duct, such as biliary atresia and jaundice.

[0004] For example, Patent Document 1 discloses a stent kit comprising a tube stent having a stent arc portion at least one end of which is formed by at least a portion of an arc, and an inner catheter having an inner arc portion formed with the same shape as the stent arc portion and inserted into the tube stent so that the positions of the inner arc portion and the stent arc portion coincide. Patent Document 2 discloses a catheter comprising: a tube having a cylindrical wall, a first end, a second end, a first retaining feature near the first end, and a second retaining feature near the second end; a detachable portion fluidly communicating with the tube at the second end and removably attachable to the tube; an inner tube having at least one lumen, the inner tube being removably insertable into both the tube and the detachable portion; and a wire extending through at least a portion of at least one lumen of the inner tube, a portion of the wire being attached to the tube. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2015-008862 [Patent Document 2] Special Publication No. 2017-502818 Summary of the Invention [Problem to be solved by the invention]

[0006] There has been a demand for the ability to observe the inside of a biological lumen that is occluded or narrowed during a procedure. With the tube stents described in Patent Documents 1 and 2, when the tube stent is placed in the occluded or narrowed area, the occluded or narrowed area is covered by the placed tube stent, making it impossible to observe, and there is room for improvement.

[0007] There has also been a demand for photodynamic therapy by irradiating light onto an occluded or narrowed biological lumen while expanding the occluded or narrowed biological lumen with a tube stent. The tube stents described in Patent Documents 1 and 2 are unable to irradiate light onto the occluded or narrowed area, and there is room for improvement in this regard as well.

[0008] The present invention has been made in view of the above circumstances, and an object of the present invention is to provide an in-vivo indwelling device that allows observation of a living lumen and irradiation of the living lumen with light. [Means for solving the problem]

[0009] The in-vivo indwelling device according to the embodiment of the present invention that can solve the above problems is as follows. [1] An in-vivo indwelling device having a tube, the tube has a first section, a second section, and a third section located between the first section and the second section in an extension direction of the tube; The in-vivo indwelling device wherein the tube in the third section has a portion with higher light transmittance than the tube in at least one of the first section and the second section. [2] The in-vivo indwelling device according to [1], wherein the tube in the third section is made of a transparent or translucent material that allows light to pass through. [3] The in-vivo indwelling device according to [1] or [2], wherein at least one of the color of the tube in the first section and the color of the tube in the second section is different from the color of the tube in the third section. [4] The in-vivo indwelling device according to any one of [1] to [3], wherein at least one of the tube in the first section and the tube in the second section is made of an opaque material. [5] The first section is located at a distal portion of the tube; the second section is located at a proximal portion of the tube; The in-vivo indwelling device according to any one of [1] to [4], wherein the tube in the second section is made of an opaque material. [6] The in-vivo indwelling device according to any one of [1] to [5], wherein the tube in the third section has a low light transmittance portion and a high light transmittance portion having a light transmittance higher than that of the low light transmittance portion. [7] The in-vivo indwelling device according to any one of [1] to [6], wherein the tube is provided with a position marker. [8] The in-vivo indwelling device according to [7], wherein the position marker has an X-ray opaque portion. [9] The tube is provided with a position marker; The in-vivo indwelling device according to [6], wherein the position of the position marker in the circumferential direction of the tube at least partially corresponds to the position of the high light transmittance portion in the circumferential direction of the tube.

[10] The first section is located at a distal portion of the tube; the second section is located at a proximal portion of the tube; The in-vivo indwelling device according to any one of [1] to [9], wherein the tube forms an arcuate portion that is curved in an arc shape in at least one of the first section and the second section. [Effects of the Invention]

[0010] According to the in-vivo indwelling device of the present invention, the tube in the third section located between the first section and the second section has a portion with higher light transmittance than the tube in at least one of the first and second sections, which allows light to easily pass through the tube in the third section, making it possible to observe the biological lumen or irradiate the biological lumen with light in the portion of the third section with high light transmittance. [Brief explanation of the drawings]

[0011] [Figure 1] 1 is an overall view of an in-vivo indwelling device according to one embodiment of the present invention. [Figure 2] FIG. 10 is an overall view of an in-vivo indwelling device according to another embodiment of the present invention. [Figure 3] FIG. 3 shows a cross-sectional view of the in-vivo indwelling device shown in FIG. 2 taken along line III-III. [Figure 4] 4 shows a cross-sectional view of the in-vivo indwelling device shown in FIG. 2 taken along line IV-IV. [Figure 5] 10 is an overall view of an in-vivo indwelling device according to still another embodiment of the present invention. FIG. [Figure 6] FIG. 10 is an overall view of an in-vivo indwelling device according to another embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0012] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols may be omitted in the drawings. In such cases, reference should be made to the specification or other drawings. The dimensions of various components in the drawings may differ from actual dimensions, as priority is given to helping understand the features of the present invention.

[0013] Fig. 1 is an overall view of an in-vivo indwelling device 1 in an embodiment of the present invention, Fig. 2 is an overall view of an in-vivo indwelling device 1 in another embodiment of the present invention, and Figs. 3 and 4 are cross-sectional views perpendicular to the longitudinal direction x of the in-vivo indwelling device 1. Fig. 5 is an overall view of an in-vivo indwelling device 1 in yet another embodiment of the present invention, and Fig. 6 is an overall view of an in-vivo indwelling device 1 in another embodiment of the present invention. As shown in Figs. 1 to 6, the in-vivo indwelling device 1 has a tube 10.

[0014] In the present invention, the proximal side refers to the side closer to the user with respect to the longitudinal direction x of the in-vivo indwelling device 1, and the distal side refers to the side opposite the proximal side, i.e., the side where treatment is performed by the in-vivo indwelling device 1 (the side of the lesion). The longitudinal direction x of the in-vivo indwelling device 1 can also be rephrased as the near-to-far direction of the in-vivo indwelling device 1. The longitudinal direction x of the in-vivo indwelling device 1 can also be rephrased as the longitudinal direction x of the tube 10, and the near-to-far direction of the in-vivo indwelling device 1 can also be rephrased as the near-to-far direction of the tube 10. Furthermore, when each member or part is divided into two equal parts in the longitudinal direction x of the tube 10, the part of each member or part located on the distal side is referred to as the distal part of each member or part, and the part of each member or part located on the proximal side is referred to as the proximal part of each member or part. The distal end of each member or part is the end located most distally of each member or part. The proximal end of each member or part is the end of the member or part that is located closest to the other. The end includes the peripheral portion of the end. That is, the distal end refers to the distal end and the peripheral portion of the distal end, and the proximal end refers to the proximal end and the peripheral portion of the proximal end.

[0015] Additionally, a radial direction y and a circumferential direction z are defined as directions orthogonal to the longitudinal direction x. The radial direction y is a direction perpendicular to the longitudinal direction x, and is a direction connecting the centroid of the outer edge of the tube 10 to a point on the outer edge in a cross section perpendicular to the longitudinal direction x. The circumferential direction z is a direction along the outer edge of the tube 10 in a cross section perpendicular to the longitudinal direction x.

[0016] The tube 10 of the in-vivo indwelling device 1 is preferably a long object having an inner lumen and one end and the other end. Examples of the in-vivo indwelling device 1 include stents. Of these, the in-vivo indwelling device 1 is preferably a plastic stent.

[0017] Examples of materials that can be used to form the tube 10 include polyamide resins, polyester resins, polyurethane resins, polyolefin resins, fluorine-based resins, vinyl chloride resins, silicone resins, and natural rubber. These materials can be used alone or in combination. Among these, the resin that forms the tube 10 is preferably at least one of polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins. By using at least one of polyamide resins, polyester resins, polyurethane resins, polyolefin resins, and fluorine-based resins as the material for the tube 10, the slipperiness of the surface of the tube 10 can be increased, thereby improving the ease of insertion into a biological lumen. The tube 10 can be manufactured using conventional methods such as extrusion molding and injection molding.

[0018] The material constituting the tube 10 may include a filler. The material constituting the filler may be an organic material, an inorganic material, or an organic-inorganic composite material. Examples of organic materials include thermosetting resins such as phenol, epoxy, and urea, and thermoplastic resins such as polyester, polyvinylidene chloride, polystyrene, and polymethacrylate. Examples of inorganic materials include metals such as platinum, nickel, and titanium, shirasu, pearlite, glass, silica, alumina, zirconia, and carbon. The shape of the filler may be, for example, particulate (e.g., spherical), acicular, fibrous, or plate-like.

[0019] It is preferable that the filler contained in the material constituting the tube 10 contains a radiopaque substance. When the material constituting the tube 10 contains a filler containing a radiopaque substance, the tube 10 can be seen under X-ray fluoroscopy, making it easier to place the in-vivo indwelling device 1 at the target site.

[0020] 1, 2, 5, and 6, the tube 10 has, in the extension direction of the tube 10, a first section 21, a second section 22, and a third section 23 located between the first section 21 and the second section 22. In other words, the tube 10 has the first section 21, the third section 23, and the second section 22 in this order along the extension direction of the tube 10.

[0021] Although not shown, the tube 10 may further have sections different from the first section 21, the second section 22, and the third section 23. Specifically, in the extension direction of the tube 10, a region different from the first section 21, the second section 22, and the third section 23 may be provided between the first section 21 and the third section 23, between the second section 22 and the third section 23, on the side of the first section 21 opposite to the side where the third section 23 is located, on the side of the second section 22 opposite to the side where the third section 23 is located, etc.

[0022] The tube 10 in the third section 23 has a portion with higher light transmittance than the tube 10 in at least one of the first section 21 and the second section 22. Because the tube 10 in the third section 23 has a portion with higher light transmittance than the tube 10 in at least one of the first section 21 and the second section 22, light can pass through the tube 10 in this high light transmittance portion of the third section 23. As a result, it becomes possible to observe the biological lumen or irradiate the biological lumen with light in the high light transmittance portion of the third section 23.

[0023] The tube 10 in the third section 23 has a portion with higher light transmittance than the tube 10 in the first section 21, a portion with higher light transmittance than the tube 10 in the second section 22, or a portion with higher light transmittance than both the tube 10 in the first section 21 and the tube 10 in the second section 22. In particular, the tube 10 in the third section 23 preferably has a portion with higher light transmittance than the tube 10 in the first section 21 and the second section 22. By the tube 10 in the third section 23 having a portion with higher light transmittance than the tube 10 in the first section 21 and the second section 22, the central section of the tube 10 has a portion with higher light transmittance than both end sections, and the in-vivo indwelling device 1 can be made easy to handle without distinction between near and far sides of the tube 10.

[0024] The peripheral wall (side wall) of the tube 10 may have holes that connect the inner cavity of the tube 10 to the outside of the tube 10. If holes are provided in the peripheral wall of the tube 10, these holes will not be considered to be areas with high light transmittance. In other words, when measuring areas with high light transmittance in the tube 10, light that passes through holes provided in the peripheral wall of the tube 10 will not be used in measuring the light transmittance.

[0025] The lengths of the first section 21, the second section 22, and the third section 23 in the extension direction of the tube 10 may be the same or different. It is preferable that the first section 21, the second section 22, and the third section 23 are regions each having a length equal to or greater than 1 / 10 of the length of the tube 10 in the extension direction.

[0026] The lengths of the first section 21, the second section 22, and the third section 23 in the extension direction of the tube 10 may be the same, but it is preferable that the length of the tube 10 in the extension direction in the third section 23 be longer than the lengths of the tube 10 in the extension direction in the first section 21 and the second section 22. In other words, it is preferable that the length of the tube 10 in the extension direction in the third section 23 be longer than the length of the tube 10 in the extension direction in the first section 21, and that the length of the tube 10 in the extension direction in the third section 23 be longer than the length of the tube 10 in the extension direction in the second section 22.

[0027] The first section 21 is preferably located in a distal portion of the tube 10, and the second section 22 is preferably located in a proximal portion of the tube 10. Furthermore, the first section 21 more preferably includes the distal end 10d of the tube 10, and the second section 22 more preferably includes the proximal end 10p of the tube 10. By having the first section 21 located in the distal portion of the tube 10 and the second section 22 located in the proximal portion of the tube 10, it is possible to facilitate the transmission of light in the central portion of the tube 10 where the third section 23 is located, while improving visibility in the distal portion of the tube 10 where the first section 21 is located and the proximal portion of the tube 10 where the second section 22 is located, making it easier to perform procedures such as placement and removal of the in-vivo indwelling device 1.

[0028] The tube 10 in the third section 23 is preferably made of a transparent or semi-transparent material that allows light to pass through. By making the tube 10 in the third section 23 of a transparent or semi-transparent material that allows light to pass through, the light transmittance of the tube 10 in the third section 23 can be easily increased.

[0029] At least one of the tube 10 in the first section 21 and the tube 10 in the second section 22 is preferably made of an opaque material. That is, the tube 10 in at least one of the first section 21 and the second section 22 is preferably made of an opaque material having a lower light transmittance than the tube 10 in the third section 23. Making the tube 10 in at least one of the first section 21 and the second section 22 of an opaque material improves the visibility of the tube 10 in the first section 21 or the second section 22, facilitating operations such as placement, position adjustment, and removal of the in-vivo indwelling device 1 in a biological lumen.

[0030] The tube 10 in the first section 21 and the tube 10 in the second section 22 are preferably made of an opaque material. That is, the tube 10 in both the first section 21 and the second section 22 are more preferably made of an opaque material having a lower light transmittance than the tube 10 in the third section 23. By making the tube 10 in both the first section 21 and the second section 22 out of an opaque material, the visibility of the tube 10 in both the first section 21 and the second section 22 can be improved, and the visibility of the in-vivo indwelling device 1 in the biological lumen can be further improved.

[0031] The first section 21 is located at the distal portion of the tube 10, and the second section 22 is located at the proximal portion of the tube 10, and the tube 10 in the second section 22 is preferably made of an opaque material. That is, the proximal portion of the tube 10 in the intracorporeal indwelling device 1 is preferably made of an opaque material. By making the second section 22 of the tube 10 from an opaque material, the proximal portion of the tube 10 becomes opaque. Therefore, when removing the intracorporeal indwelling device 1 or adjusting its position, it becomes easier to grasp the proximal portion of the tube 10, making the procedure easier to perform.

[0032] It is preferable that the first section 21 of the tube 10 located in the distal portion of the tube 10 has a portion with high light transmittance. By having the first section 21 of the tube 10 located in the distal portion of the tube 10 have a portion with high light transmittance, the distal portion of the tube 10 has a portion that can transmit light, and it becomes possible to observe the biological lumen and irradiate the biological lumen with light in the portions with high light transmittance not only in the third section 23 but also in the first section 21.

[0033] It is more preferable that the first section 21 is located in the distal portion of the tube 10, and that the tube 10 in the first section 21 is made of a transparent or semi-transparent material. By making the tube 10 in the first section 21 out of a transparent or semi-transparent material, light can be transmitted even in the distal portion of the tube 10. Therefore, light can be irradiated to observe the more distal side of the biological lumen.

[0034] It is preferable that at least one of the colors of the tube 10 in the first section 21 and the second section 22 is different from the color of the tube 10 in the third section 23. The difference between the color of the tube 10 in at least one of the first section 21 and the second section 22 and the color of the tube 10 in the third section 23 refers to a difference in at least one of the hue, brightness, and saturation defined by JIS Z8721. By making the color of the tube 10 in at least one of the first section 21 and the second section 22 different from the color of the tube 10 in the third section 23, the visibility of the tube 10 in the first section 21 and the second section 22 can be improved. As a result, it becomes easier to confirm the tube 10 in the first section 21 and the second section 22 in the biological lumen, facilitating the placement and removal of the in-vivo indwelling device 1.

[0035] It is more preferable that the color of the tube 10 in the first section 21 and the color of the tube 10 in the second section 22 are different from the color of the tube 10 in the third section 23. In other words, it is more preferable that the color of the tube 10 in both the first section 21 and the second section 22 are different from the color of the tube 10 in the third section 23. By making the color of the tube 10 in both the first section 21 and the second section 22 different from the color of the tube 10 in the third section 23, it is possible to improve visibility in the biological lumen in both the first section 21 and the second section 22. It is to be noted that the color of the tube 10 in the first section 21 and the color of the tube 10 in the second section 22 may be the same or different.

[0036] The first section 21 is located in the distal portion of the tube 10, and the second section 22 is located in the proximal portion of the tube 10, and it is preferable that the color of the tube 10 in the second section 22 is different from the color of the tube 10 in the third section 23. The different colors of the tube 10 in the second section 22 and the third section 23 improve the visibility of the proximal portion of the tube 10, making it easier to grasp the proximal portion of the tube 10 when removing the in-vivo indwelling device 1 or adjusting its position, and facilitating smoother procedures.

[0037] The portion having higher light transmittance than the tube 10 in at least one of the first section 21 and the second section 22 may be only a portion of the tube 10 in the third section 23, or may be the entire tube 10 in the third section 23.

[0038] 2, 5, and 6, the tube 10 in the third section 23 preferably has a low light transmission portion 31 and a high light transmission portion 32 having a higher light transmittance than the low light transmission portion 31. By having the tube 10 in the third section 23 have the low light transmission portion 31 and the high light transmission portion 32, it is possible to particularly increase the light transmittance in the portion of the third section 23 where the high light transmission portion 32 is located. This makes it easier to selectively observe and irradiate light at specific sites in the biological lumen.

[0039] The low light transmission portion 31 has a lower light transmittance than the high light transmission portion 32. The low light transmission portion 31 may have a lower light transmittance than, the same light transmittance as, or a higher light transmittance than at least one of the tube 10 in the first section 21 and the tube 10 in the second section 22. In particular, the low light transmission portion 31 preferably has a higher light transmittance than at least one of the tube 10 in the first section 21 and the tube 10 in the second section 22. By having a higher light transmittance in the low light transmission portion 31 than at least one of the tube 10 in the first section 21 and the tube 10 in the second section 22, the light transmittance in the low light transmission portion 31 can be increased compared to the first section 21 and the second section 22, making it possible to observe and irradiate a biological lumen in the third section 23.

[0040] In the third section 23, the high light transmission portion 32 may extend over the entire circumference of the tube 10 in the circumferential direction z, or may be present only in a portion of the circumference of the tube 10. Furthermore, in the third section 23, the high light transmission portion 32 may extend over the entire length of the tube 10 in the longitudinal direction x, or may be present only in a portion of the length of the tube 10 in the longitudinal direction x. Similarly, in the third section 23, the low light transmission portion 31 may extend over the entire circumference of the tube 10 in the circumferential direction z, or may be present only in a portion of the tube 10 in the circumferential direction z, or may extend over the entire length of the tube 10 in the longitudinal direction x, or may be present only in a portion of the tube 10 in the longitudinal direction x.

[0041] In particular, it is preferable that the highly light-transmitting portion 32 extend in the third section 23 in part of the circumferential direction z of the tube 10 and in part of the longitudinal direction x of the tube 10. By having the highly light-transmitting portion 32 extend in the third section 23 in part of the circumferential direction z of the tube 10 and in part of the longitudinal direction x of the tube 10, it is possible to provide an in-vivo indwelling device 1 that makes it easy to selectively observe or irradiate a biological lumen at a specific site.

[0042] As shown in Figures 2, 5, and 6, it is preferable that a position marker 40 is provided on the tube 10. The position marker 40 is also called a visible marker and is a component for confirming the position of the intravital indwelling device 1 in the biological lumen. By providing the position marker 40 on the tube 10, the position of the intravital indwelling device 1 in the biological lumen can be recognized under X-ray fluoroscopy or with a camera, etc., making it easier to perform the procedure. When the position marker 40 is visually confirmed with a camera, the camera may, for example, visually confirm the position marker 40 from the proximal side of the intravital indwelling device 1, or the camera may be inserted into the lumen of the tube 10 and visually confirm the position marker 40 from a portion of the third section 23 with high light transmittance. The number of position markers 40 provided on the tube 10 may be one or more.

[0043] Methods for constructing the position marker 40 include arranging a member on the tube 10, partially coloring the surface of the tube 10, partially removing a coating applied to the surface of the tube 10, and partially changing the material from which the tube 10 is made. The coloring of the surface of the tube 10 may be coloring the outer surface of the tube 10, or may be coloring the inner surface of the tube 10. The removal of the coating on the surface of the tube 10 may be removing a coating applied to the outer surface of the tube 10, or may be removing a coating applied to the inner surface of the tube 10. Among these, the position marker 40 is preferably constructed by arranging a member on the tube 10. By constructing the position marker 40 by arranging a member on the tube 10, the visibility of the position marker 40 can be easily improved, and the rigidity of the portion where the position marker 40 is provided can be increased, thereby improving the insertability of the in-vivo indwelling device 1.

[0044] When the position marker 40 is constructed by placing a component in the tube 10, the component may have, for example, a cylindrical shape, a polygonal tube shape, a C-shaped cross section with a notch in the tube, or a coil shape with wire wound around it.

[0045] It is preferable that the position marker 40 is a color different from that of the tube 10 where the position marker 40 is provided. By making the position marker 40 a color different from that of the tube 10, it becomes easier to ensure the visibility of the position marker 40. Furthermore, the position marker 40 may be an X-ray opaque marker containing an X-ray opaque substance, a magnetic marker containing magnetic particles or the like, an optical marker containing a phosphor or the like, or the like.

[0046] The position marker 40 preferably has an X-ray opaque portion. By having the position marker 40 have an X-ray opaque portion, the position of the position marker 40 can be confirmed under X-ray fluoroscopy, and procedures such as placement and removal of the in-vivo indwelling device 1 can be performed more safely.

[0047] The radiopaque portion of the position marker 40 may constitute a part of the position marker 40, or may constitute the entire position marker 40. Examples of materials that constitute the radiopaque portion include radiopaque materials such as lead, barium, iodine, tungsten, gold, platinum, iridium, stainless steel, titanium, and cobalt-chromium alloy.

[0048] The position marker 40 is preferably provided in at least one of the first section 21, the second section 22, and the third section 23. That is, the position marker 40 is preferably provided on the tube 10 in at least one of the first section 21, the second section 22, and the third section 23. By providing the position marker 40 in the first section 21, the position of the distal portion of the tube 10 can be confirmed, and when placing the in-vivo indwelling device 1, it is possible to recognize how far the tube 10 has been inserted into the biological lumen, facilitating distal positioning. By providing the position marker 40 in the second section 22, it is easy to confirm the position of the proximal portion of the tube 10, making it easy to prevent the in-vivo indwelling device 1 from being inserted too far into the biological lumen. Furthermore, even if the in-vivo indwelling device 1 accidentally strays into the biological lumen, it is easy to find the proximal portion of the tube 10. By providing the position marker 40 in the third section 23, it is easy to recognize the position of the portion with high light transmittance.

[0049] The position marker 40 may be provided across multiple sections, namely, the first section 21, the second section 22, and the third section 23. Specifically, the position marker 40 may extend continuously in the longitudinal direction x of the tube 10 across the first section 21 and the third section 23, may extend continuously in the longitudinal direction x of the tube 10 across the second section 22 and the third section 23, or may extend continuously in the longitudinal direction x of the tube 10 across the first section 21, the third section 23, and the second section 22.

[0050] The position marker 40 may extend over the entire circumference of the tube 10 in the circumferential direction z, or may be present only on a portion of the circumference of the tube 10 in the circumferential direction z. Furthermore, the position marker 40 may extend over the entire length of the tube 10 in the longitudinal direction x, or may be present only on a portion of the tube 10 in the longitudinal direction x.

[0051] In particular, it is preferable that the position marker 40 is arranged continuously in the longitudinal direction x of the tube 10 in a portion of the circumferential direction z of the tube 10. In other words, it is preferable that the position marker 40 extends linearly along the longitudinal direction x of the tube 10. By arranging the position marker 40 continuously in the longitudinal direction x in a portion of the circumferential direction z of the tube 10, the visibility of the position marker 40 is likely to be improved, making it easier to recognize the position of the in-vivo indwelling device 1 in the biological lumen.

[0052] It is preferable that the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially correspond to the position of the high light transmission portion 32 in the circumferential direction z of the tube 10. Examples of a configuration in which the position of the position marker 40 in the circumferential direction z of the tube 10 corresponds to the position of the high light transmission portion 32 include a configuration in which the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlaps with the position of the high light transmission portion 32, or a configuration in which the position of the position marker 40 in the circumferential direction z of the tube 10 is offset by a predetermined angle, such as 90 degrees or 180 degrees, from the position of the high light transmission portion 32 in the circumferential direction z of the tube 10. Since the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially corresponds to the position of the high light transmission portion 32 in the circumferential direction z of the tube 10, the position of the high light transmission portion 32 in the circumferential direction z of the tube 10 can be recognized by checking the position of the position marker 40 in the circumferential direction z of the tube 10, even when the intra-vivo indwelling device 1 is placed in a biological lumen. Therefore, procedures using the in-vivo indwelling device 1 can be performed more easily.

[0053] 3 and 4, it is preferable that the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlaps with the position of the high light transmittance portion 32 in the circumferential direction z of the tube 10. By having the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlap with the position of the high light transmittance portion 32, it is easy to recognize the position of the high light transmittance portion 32 in the circumferential direction z of the tube 10, and it becomes easier to perform procedures using the in-vivo indwelling device 1 efficiently.

[0054] It is more preferable that the position marker 40 is disposed in at least one of the first section 21 and the second section 22, and that the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlaps with the position of the high light transmittance portion 32 in the circumferential direction z of the tube 10. By disposing the position marker 40 in at least one of the first section 21 and the second section 22, and further by having the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlap with the position of the high light transmittance portion 32 in the circumferential direction z of the tube 10, it becomes easier to confirm the position of the high light transmittance portion 32.

[0055] When the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlaps with the position of the high light transmission portion 32 in the circumferential direction z of the tube 10, the position marker 40 is more preferably arranged in the second section 22 located in the proximal portion of the tube 10. When the position marker 40 is arranged in the second section 22 and the position of the position marker 40 in the circumferential direction z of the tube 10 at least partially overlaps with the position of the high light transmission portion 32, the position marker 40 is located in the proximal portion of the tube 10, which increases the visibility of the position marker 40 and makes it easier to recognize the position of the high light transmission portion 32.

[0056] As shown in FIGS. 2 and 5 , the tube 10 preferably forms an arcuate portion 50 in at least one of the first section 21 and the second section 22. The arcuate portion 50 refers to the portion of the tube 10 that is curved in an arcuate shape when no external force other than gravity is applied to the tube 10. The arcuate portion 50 may be formed by the entire tube 10 in the first section 21 or the second section 22, or may be formed by a portion of the tube 10 in the first section 21 or the second section 22. In other words, the arcuate portion 50 is preferably formed by at least a portion of the tube 10 in the first section 21 or the second section 22. By forming the arcuate portion 50 in at least one of the first section 21 and the second section 22, the biological indwelling device 1 can be prevented from moving after being placed at a target site in a biological lumen, and the position at which the biological indwelling device 1 is placed can be prevented from shifting.

[0057] The arc portion 50 has the function of contacting the biological lumen and fixing the biological indwelling device 1 to the biological lumen. Specifically, for example, if the biological indwelling device 1 is a bile duct stent, the first arc portion 51, which is the arc portion 50 of the first section 21 located in the distal portion, may be placed distal to the narrowed or obstructed section of the bile duct to prevent the biological indwelling device 1 from falling out from the bile duct toward the duodenum. Furthermore, for example, if the biological indwelling device 1 is a bile duct stent, the second arc portion 52, which is the arc portion 50 of the second section 22 located in the proximal portion, may be placed near the papilla of the duodenum to prevent the biological indwelling device 1 from getting lost in the bile duct.

[0058] The shape of the arc portion 50 may be an arc shape such as an unclosed semicircle, or may be a closed circle. If the shape of the arc portion 50 is an unclosed arc shape, the in-vivo indwelling device 1 can be easily inserted into a biological lumen, etc. Furthermore, if the shape of the arc portion 50 is a closed circle, the effect of fixing the in-vivo indwelling device 1 in a predetermined position can be improved.

[0059] When the tube 10 forms an arcuate portion 50 in both the first section 21 and the second section 22, it is preferable that the tube 10 be straight in the third section 23. That is, it is preferable that the tube 10 does not have an arcuate curved portion in the third section 23. By making the tube 10 straight in the third section 23, when the in-vivo indwelling device 1 is placed in a biological lumen, the in-vivo indwelling device 1 can easily conform to the biological lumen and is less likely to impose a large load on portions other than the narrowed or obstructed portion, thereby improving the minimally invasive nature of the in-vivo indwelling device 1.

[0060] When the tube 10 forms an arc portion 50 in both the first section 21 and the second section 22, the shape of the first arc portion 51 may be the same as or different from the shape of the second arc portion 52. Specifically, the shapes of the first arc portion 51 and the second arc portion 52 may both be arc shapes that are not closed circles, or the shapes of the first arc portion 51 and the second arc portion 52 may both be closed circles, or one of the first arc portion 51 and the second arc portion 52 may be arc shapes that are not closed circles and the other one may be closed circles.

[0061] It is preferable that the tube 10 forms an arc portion 50 in the first section 21, and that the tube 10 does not form an arc portion 50 in the second section 22 and the third section 23. In other words, it is preferable that the tube 10 is curved in an arc shape in the first section 21 located on the distal side of the tube 10, and that the tube 10 is not curved in an arc shape in the second section 22 located on the proximal side of the tube 10 and in the third section 23 located between the first section 21 and the second section 22 in the longitudinal direction x of the tube 10. In the first section 21, the tube 10 forms an arc portion 50, but in the second section 22 and the third section 23, the tube 10 does not form an arc portion 50. As a result, the arc portion 50 in the first section 21 prevents the in-vivo retention device 1 from shifting position after placement, while in the second section 22 and the third section 23, the tube 10 is not curved in an arc shape, making it easier to insert a camera for observing the biological lumen, a light source for performing photodynamic therapy, etc. into the lumen of the tube 10 from the proximal end 10p of the tube 10.

[0062] 6, the tube 10 may have a flap 60 having a base 61 and a free end 62 in at least one of the first section 21 and the second section 22. That is, the in-vivo indwelling device 1 may have at least one of a distal flap 63 in the first section 21 that extends from the distal side to the proximal side in the radial direction y, and a proximal flap 64 in the second section 22 that extends from the proximal side to the distal side in the radial direction y.

[0063] The flap 60 is a member that prevents displacement of the in-vivo indwelling device 1 placed in the biological lumen. By having the flap 60 on the tube 10 in at least one of the first section 21 and the second section 22, it is possible to prevent the in-vivo indwelling device 1 from shifting its position after being placed at a target site in the biological lumen. Specifically, if the tube 10 has a proximal flap 64 in the second section 22, it is possible to prevent the proximal end 10p of the tube 10 from entering further distally than the papilla of the duodenum when the in-vivo indwelling device 1 is placed in the bile duct. Furthermore, if the tube 10 has a distal flap 63 in the first section 21, it is possible to prevent the in-vivo indwelling device 1 from falling out of the bile duct into the duodenum when the in-vivo indwelling device 1 is placed in the bile duct.

[0064] The flap 60 may be formed, for example, by cutting a cut in the surface of the tube 10 and causing a portion of the tube 10 to protrude outward at an angle relative to the extension direction of the tube 10, or by providing a member different from the tube 10 on the tube 10. When the flap 60 is formed by cutting a cut in the surface of the tube 10, the flap 60 is less likely to fall off the tube 10. Furthermore, when the flap 60 is formed by providing a member different from the tube 10 on the tube 10, the flap 60 is less likely to tear when a load is applied to the flap 60 in a proximal or distal direction.

[0065] When the flap 60 is formed by providing the tube 10 with a flap member that is a different member from the tube 10, the flap member may be made of the same material as the material that constitutes the tube 10, or a different material from the material that constitutes the tube 10. In particular, the material that constitutes the flap member is preferably the same as the material that constitutes the tube 10. When the flap member is made of the same material as the material that constitutes the tube 10, the bonding strength between the flap member and the tube 10 is likely to be increased, and the flap member can be firmly fixed to the tube 10.

[0066] Methods for joining the flap members and the tube 10 include, for example, heat welding, ultrasonic welding, and bonding with an adhesive. Among these, it is preferable to join the flap members and the tube 10 by heat welding. By joining the flap members and the tube 10 by heat welding, the joining strength between the flap members and the tube 10 can be easily increased.

[0067] 6, the distal flap 63 is preferably formed by cutting a cut in the surface of the tube 10 and causing a portion of the tube 10 to protrude outward at an angle relative to the extension direction of the tube 10. By forming the distal flap 63 by cutting a cut in the tube 10, for example, when the distal end of the in-vivo indwelling device 1 comes into contact with the papilla of the duodenum in order to place the in-vivo indwelling device 1 in the bile duct, the distal flap 63 closes along the tube 10, making it easier to reduce the outer diameter, and the in-vivo indwelling device 1 can be made easier to deliver to the target site.

[0068] The intracorporeal indwelling device 1 may have one or more distal flaps 63. When the intracorporeal indwelling device 1 has multiple distal flaps 63, the number of distal flaps 63 can be two or more, three or more, or five or less.

[0069] When the in-vivo indwelling device 1 has a plurality of distal flaps 63, the distal flaps 63 are preferably arranged at equal intervals in the circumferential direction z of the tube 10. By arranging a plurality of distal flaps 63 at equal intervals in the circumferential direction z of the tube 10, it is possible to improve the effect of preventing the in-vivo indwelling device 1 from shifting from the placement location.

[0070] When the in-vivo indwelling device 1 has a plurality of distal flaps 63, the length from the base 61 to the free end 62 of the distal flaps 63, the width of the distal flaps 63, and the thickness of the distal flaps 63 may all be the same or different. If the length, width, and thickness of each distal flap 63 are the same, the manufacture of the in-vivo indwelling device 1 is facilitated, and production efficiency can be improved. Furthermore, if the length, width, and thickness of each distal flap 63 are different, the strength of each distal flap 63 can be changed. As a specific example, the strength of distal flaps 63 arranged in locations that are prone to stress and are at risk of breaking can be increased, and the rigidity of distal flaps 63 arranged in locations where flexibility is required can be reduced to impart flexibility.

[0071] 6, the proximal flap 64 is preferably formed by providing a flap member, which is a member different from the tube 10, on the tube 10. By providing the proximal flap 64 on the tube 10 with a flap member, the proximal flap 64 is less likely to tear and can be prevented from falling off the tube 10 when a force is applied to the proximal flap 64 in a direction from the distal side to the proximal side, such as when the in-vivo indwelling device 1 is placed in the bile duct and the proximal flap 64 comes into contact with the duodenal papilla.

[0072] The intra-vivo indwelling device 1 may have one or more proximal flaps 64. When the intra-vivo indwelling device 1 has multiple proximal flaps 64, the number of proximal flaps 64 can be two or more, three or more, or five or less.

[0073] As with the distal flaps 63 described above, when the in-vivo indwelling device 1 has a plurality of proximal flaps 64, the proximal flaps 64 are preferably arranged at equal intervals in the circumferential direction z of the tube 10. Furthermore, when the in-vivo indwelling device 1 has a plurality of proximal flaps 64, the lengths from the bases 61 to the free ends 62 of the proximal flaps 64, as well as the widths and thicknesses of the proximal flaps 64 may all be the same or different. [Explanation of symbols]

[0074] 1: Intravital device 10: Tube 10d: Distal end of the tube 10p: proximal end of the tube 21: First Section 22: Second Section 23: Third Section 31: Low light transmission area 32: High light transmission part 40: Position marker 50: Arc section 51: First arc 52: Second arc section 60: Flap 61: Base 62: Free end 63: Distal flap 64: Proximal flap x: Longitudinal direction y: radial direction z: Circumferential direction

Claims

1. An in-vivo indwelling device having a tube, the tube has a first section, a second section, and a third section located between the first section and the second section in an extension direction of the tube; The in-vivo indwelling device has a portion in the third section that has a higher light transmittance than the tube in at least one of the first section and the second section.

2. 2. The in-vivo indwelling device according to claim 1, wherein the tube in the third section is made of a transparent or semi-transparent material that allows light to pass through.

3. 2. The in-vivo indwelling device according to claim 1, wherein at least one of the color of the tube in the first section and the color of the tube in the second section is different from the color of the tube in the third section.

4. 2. The in-vivo indwelling device according to claim 1, wherein at least one of the tube in the first section and the tube in the second section is made of an opaque material.

5. the first section is located at a distal portion of the tube; the second section is located at a proximal portion of the tube; 2. The in-vivo indwelling device according to claim 1, wherein the tube in the second section is made of an opaque material.

6. 2. The in-vivo indwelling device according to claim 1, wherein the tube in the third section has a low light transmittance portion and a high light transmittance portion having a light transmittance higher than that of the low light transmittance portion.

7. 2. The in-vivo indwelling device according to claim 1, wherein the tube is provided with a position marker.

8. 8. The in-vivo indwelling device according to claim 7, wherein the position marker has an X-ray opaque portion.

9. The tube is provided with a position marker; 7. The in-vivo indwelling device according to claim 6, wherein the position of the position marker in the circumferential direction of the tube at least partially corresponds to the position of the high light transmittance portion in the circumferential direction of the tube.

10. the first section is located at a distal portion of the tube; the second section is located at a proximal portion of the tube; 2. The in-vivo indwelling device according to claim 1, wherein the tube has an arcuate portion curved in an arc shape in at least one of the first section and the second section.

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