Intra-biological implantable devices

Abstract

To provide an in-vivo device that can efficiently release drugs within the body. [Solution] An in-vivo implantation device 1 comprising a coil 10 having a lumen 11, and a linear stretch-resistant member 30 disposed in the lumen 11 and having fibers 31 containing a polymer material and a drug.

Description

Technical Field

[0001] The present invention relates to an implant for forming an embolism in a blood vessel of a diseased blood vessel part.

Background Art

[0002] Endovascular treatment is one of the treatment methods for vascular lesions such as aneurysms, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal arteries, and abdominal aneurysms in the head and neck. In endovascular treatment, an embolization procedure is used to prevent, for example, the rupture of an aneurysm by implanting an implant having a coil for embolization at the target site and promoting thrombosis. In the embolization procedure, a technique of packing coils into the aneurysm is performed, and it has phases of Framing, Filling, and Finishing. In the embolization procedure, coils with different flexibilities are generally selected for each phase. For example, in the Framing phase, it is necessary to create a framework shape inside the aneurysm by making the coil crawl along the inner surface of the aneurysm. On the other hand, in the phases after Filling, since the coil is filled into the framework formed in the Framing phase, a coil having greater flexibility than that in Framing is selected. Several to several tens of coils are used in a single embolization procedure. Patent Document 1 discloses that in a vascular embolization device implanted in the body, a resin wire inserted inside a metal coil contains a drug.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, the vascular embolization device described in Patent Document 1 has room for improvement from the viewpoint of the drug release efficiency. Therefore, an object of the present invention is to provide an implant that can efficiently release a drug in the body. [Means for solving the problem]

[0005] The in-vivo implantable device according to an embodiment of the present invention that can solve the above problems is as follows. [1] A coil having a lumen, An in-vivo implant comprising a linear stretch-resistant member disposed within the lumen and having fibers containing a polymer material and a drug.

[0006] Furthermore, the in-vivo implantation device according to the embodiment is preferably one of the following [2] to

[12] . [2] The in-vivo implantation device according to [1], wherein the stretch-resistant member is composed solely of the fibers. [3] The intravascular device according to [1] or [2], wherein the fiber contains a mixture of the polymer material and the drug. [4] The intravascular device according to [1] or [2], wherein the drug is contained within the polymer material in the fiber. [5] The in vivo implantation device according to [4], wherein the fiber includes a core-sheath type fiber having a core and a sheath, the core containing the drug and the sheath containing the polymer material. [6] The in-vivo implantation device according to any one of the following [1] to [5], wherein the polymer material is a biodegradable polymer material. [7] The polymer material is a non-biodegradable polymer material, as described in any one of the claims [1] to [5]. [8] The stretch resistance member includes a first linear member and a second linear member arranged parallel to each other in the lumen, The first linear member is made of fibers containing a biodegradable polymer material and a drug, The second linear member is a fiber containing a non-biodegradable polymer material and a drug, as described in any one of the claims [1] to [7]. [9] The in-vivo implantation device further comprises a pusher positioned proximal to the coil in the longitudinal axis direction of the coil and pushing the coil distally, and a connecting portion connecting the proximal portion of the coil and the distal portion of the pusher, The in vivo implantation device according to [8], wherein the first linear member and the second linear member are fixed to the distal end of the coil and the connecting portion, respectively.

[10] The in-vivo implantation device is disposed in the lumen and further has an internal wire having fibers containing a polymer material and a drug, The internal wire is not fixed to the coil. [1] to [9] The in-vivo implantation device according to any one of these items.

[11] The in-vivo implantation device further comprises a pusher positioned proximal to the coil in the longitudinal axis direction of the coil and pushing the coil distally, and a connecting portion connecting the proximal portion of the coil and the distal portion of the pusher, The stretch resistance member is fixed to the distal end of the coil and the connection portion. The internal wire is not fixed to the connection part

[10] in the in-vivo implantation device.

[12] The intravascular implantation device according to

[10] or

[11] , wherein either the stretch-resistant member or the internal wire is made of a fiber containing a biodegradable polymer material and a drug, and the other is made of a fiber containing a non-biodegradable polymer material and a drug. [Effects of the Invention]

[0007] According to the above-mentioned in-vivo implantation device, by using fibers containing polymer materials and drugs as the stretch-resistant member, it becomes easier to secure a large surface area for the stretch-resistant member, and thus easier to release the drugs contained in the fibers. [Brief explanation of the drawing]

[0008] [Figure 1] This is a schematic diagram of an in-vivo implantable device according to an embodiment of the present invention. [Figure 2] Figure 1 shows a cross-sectional view (partially a side view) of the coil of the in-vivo implantation device along its longitudinal axis. [Figure 3] Figure 2 is a schematic diagram showing the structure of the stretch-resistant member of the in-vivo implantable device. [Figure 4]It is a cross-sectional view showing a modified example of the extension resistance member shown in FIG. 3, and shows a cross-sectional view perpendicular to the longitudinal axis direction of the extension resistance member. [Figure 5] It is a cross-sectional view (partial side view) showing a modified example of the indwelling device in the living body shown in FIG. 2. [Figure 6] It is a cross-sectional view (partial side view) showing another modified example of the indwelling device in the living body shown in FIG. 2.

Embodiments for Carrying out the Invention

[0009] Hereinafter, the present invention will be described more specifically based on the following embodiments. However, the present invention is not limited by the following embodiments, and it is of course possible to appropriately modify and implement within the range that can conform to the gist of the foregoing and following descriptions, and all of them are included in the technical scope of the present invention. In each drawing, for the sake of convenience, hatching, member codes, etc. may be omitted, but in such a case, reference shall be made to the specification and other drawings. Also, the dimensions of various members in the drawings may be different from the actual dimensions because priority is given to facilitating the understanding of the features of the present invention.

[0010] The indwelling device in the living body according to an embodiment of the present invention includes a coil having a lumen, and a linear extension resistance member disposed in the lumen and having fibers containing a polymer material and a drug. Hereinafter, the indwelling device in the living body may be simply referred to as an indwelling device. Examples of the use of the indwelling device include embolization to promote thrombosis at target sites such as cerebral aneurysms, aneurysms in the head and neck, arteriovenous malformations, arteriovenous fistulas, pulmonary vascular malformations, renal vascular malformations, renal arteries, and abdominal aneurysms. Among them, the indwelling device is preferably an indwelling device for cerebral aneurysms. Examples of the shape of the aneurysm include spindle-shaped and sac-shaped.

[0011] Embolization has phases of Framing, Filling, and Finishing. The indwelling device can be used in any one of the phases, or can be used over any two or three of the phases.

[0012] While referring to FIGS. 1 to 6, an intravascular implant according to an embodiment of the present invention will be described. FIG. 1 is a schematic diagram of an intravascular implant according to an embodiment of the present invention. FIG. 2 is a cross-sectional view (partial side view) along the longitudinal axis direction of the coil of the intravascular implant shown in FIG. 1. FIG. 3 is a schematic diagram showing the structure of the extension resistance member of the intravascular implant shown in FIG. 2. FIG. 4 is a cross-sectional view showing a modification example of the extension resistance member shown in FIG. 3, and shows a cross-sectional view perpendicular to the longitudinal axis direction of the extension resistance member. FIGS. 5 to 6 are cross-sectional views (partial side views) showing modification examples of the intravascular implant shown in FIG. 2. As shown in FIGS. 1 to 3, the implant 1 has a coil 10 and a linear extension resistance member 30.

[0013] As can be understood from FIG. 2, the coil 10 preferably has a longitudinal axis direction x, a radial direction y, and a circumferential direction z. The coil 10 preferably has a distal end and a proximal end in the longitudinal axis direction x. The proximal side of the coil 10 refers to the direction on the side of the user or the operator with respect to the longitudinal axis direction x of the coil 10, and the distal side refers to the opposite direction of the proximal side, that is, the direction of the treatment target side. In FIG. 2, the right side of the figure is the proximal side, and the left side of the figure is the distal side. The radial direction y of the coil 10 refers to the radial direction of the coil 10. In the radial direction y, the inner direction refers to the direction toward the center of the longitudinal axis of the coil 10, and the outer direction refers to the direction extending radially from the center of the longitudinal axis on the opposite side to the inner direction. The circumferential direction z of the coil 10 refers to the direction around the longitudinal axis. Hereinafter, in the longitudinal axis direction x of the coil 10, the proximal side when the length of each member is bisected may be referred to as the proximal part, and the distal side may be referred to as the distal part.

[0014] In this specification, unless otherwise specified, coil 10 refers to the configuration in the primary coil state. A primary coil that has been further shaped into a helical or three-dimensional shape is sometimes called a secondary coil. It is preferable that the coil 10 of the primary coil, as shown in Figure 2, is shaped to form the secondary coil shown in Figure 1. In Figure 1, the primary coil is wound to form a three-dimensional secondary coil shape. The coil 10 of the implantation device 1 is inserted into the lumen of the transport catheter in the form of a linear primary coil, as shown in Figure 2, and transported to the target site. When the primary coil is pushed out of the catheter, it is placed in the aneurysm in a state that has unfolded into a three-dimensional shape, as shown in Figure 1, or in a state that conforms to the shape of the aneurysm.

[0015] As shown in Figure 2, the coil 10 has a lumen 11. Preferably, the lumen 11 extends in the longitudinal axis direction x. Preferably, the coil 10 has an outer circumferential surface 12 and an inner circumferential surface 13. The outer circumferential surface 12 faces the outside of the coil 10, i.e., the outside in the radial direction y, and the inner circumferential surface 13 faces the lumen 11. A stretch resistance member 30 is disposed in the lumen 11.

[0016] As shown in Figures 1 and 2, the coil 10 is preferably constructed by winding one or more wires 21 in a helical shape. Examples of wires 21 include single wires, stranded wires, and coiled wires, with single wires being preferred. Furthermore, it is preferable that the wires 21 are not coiled wires.

[0017] The wire 21 is preferably biocompatible and flexible. Examples of materials constituting the wire 21 include platinum, gold, titanium, tungsten and their alloys, stainless steel, and other metallic materials or combinations thereof. Among these, it is more preferable that the wire 21 is composed of a platinum-tungsten alloy.

[0018] The wire 21 has a longitudinal axis direction and has a distal end and a proximal end in the longitudinal axis direction. The wire 21 may be composed of a single wire from the distal end to the proximal end, or it may be composed of multiple wires connected to each other in the longitudinal axis direction. The shape of the cross section perpendicular to the longitudinal axis direction of the wire 21 may be circular, oval, polygonal, or a combination thereof. The shape of the cross section perpendicular to the longitudinal axis direction of the wire 21 may be the same throughout the entire longitudinal axis direction of the wire 21, or it may differ depending on the position in the longitudinal axis direction.

[0019] The outer diameter of the wire 21 is not particularly limited, but may be, for example, 25 μm or more, 30 μm or more, or 35 μm or more, and may be 75 μm or less, or 70 μm or less.

[0020] The outer diameter of the wire 21 may be the same in the longitudinal direction of the wire 21, or it may be different depending on the position in the longitudinal direction of the wire 21. If the cross-section of the wire 21 is not circular, the outer diameter of the wire 21 shall refer to the equivalent diameter of a circle.

[0021] The coil 10 may be a single-layer coil or a multi-layer coil having multiple layers. A portion of the coil 10 along its longitudinal axis x may be single-layered, while the remaining portion is multi-layered.

[0022] The density of the coil 10, i.e., the winding spacing, is not particularly limited and can be tightly wound, pitched, or a combination of these. The coil 10 may have adjacent wires 21 in contact with each other in the longitudinal axis x. The coil 10 may have adjacent wires 21 in contact with each other in only a part of the longitudinal axis x, or adjacent wires 21 in contact with each other along the entire longitudinal axis x. Furthermore, the coil 10 may not have adjacent wires 21 in contact with each other in the longitudinal axis x. Non-contact means that there is a gap between adjacent wires 21 in the longitudinal axis x of the coil 10.

[0023] The shape of the cross-section of the coil 10 perpendicular to the longitudinal axis x may be circular, oval, polygonal, or a combination thereof. The oval shape includes elliptical, egg-shaped, and rounded rectangular shapes. The same applies in the following description.

[0024] The surface of the coil 10 may have an uneven surface if the cross-sections of adjacent wires 21 in the longitudinal axis x of the coil 10 are circular, elliptical, or the like.

[0025] The maximum and minimum outer diameters of coil 10 are not particularly limited and can be appropriately selected according to the phase of the procedure. For example, they may be 150 μm or more, 180 μm or more, or 200 μm or more, and may also be 400 μm or less, 380 μm or less, or 350 μm or less.

[0026] The outer diameter and / or inner diameter of the coil 10 may be the same size in the longitudinal axis x of the coil 10, or they may be different sizes depending on the position in the longitudinal axis x of the coil 10. If the cross-section of the coil 10 is not circular, the outer diameter of the coil 10 shall refer to the equivalent circular diameter. Similarly, if the inner lumen cross-section of the coil 10 is not circular, the inner diameter of the coil 10 shall refer to the equivalent circular diameter.

[0027] The coil 10 may have a constant outer diameter in the longitudinal axis direction x. A constant outer diameter means that the outer diameter of the coil 10 is substantially constant over the entire longitudinal axis direction x, and includes cases where the change in the outer diameter of the coil 10 over the entire longitudinal axis direction x is within ±5%.

[0028] As shown in Figures 1 and 2, the indwelling device 1 is positioned proximal to the coil 10 in the longitudinal axis x of the coil 10 and may further include a pusher 55 that pushes the coil 10 distally and a connecting portion 50 that connects the proximal portion of the coil 10 and the distal portion of the pusher 55.

[0029] The pusher 55 is a rod-shaped or wire-shaped member used to hold the indwelling device 1 and push it distally. The pusher 55 can consist of one or more members. The pusher 55 can consist of a wire member, a coil member, or a combination thereof. The pusher 55 can be made of a conductive material such as stainless steel.

[0030] The connection part 50 connects the coil 10 and the pusher 55. Preferably, the connection part 50 has a detachment mechanism that allows the coil 10 to detach from the pusher 55. Examples of detachment mechanisms include hydraulic, electrical, and mechanical types, and among these, it is preferable to use an electrical detachment mechanism. In the detachment mechanism, it is preferable that the connection part 50 is heated and disconnected by electrical or thermal energy supplied through the pusher 55, thereby detaching the coil 10 from the pusher 55. In this case, it is preferable that the connection part 50 is heated by a high-frequency current supplied between the distal end of the pusher 55 and the counter electrode plate.

[0031] The connecting portion 50 preferably contains a material that melts or dissolves upon heating. The connecting portion 50 can be cut by Joule heating. Examples of such materials include synthetic resin materials, and it is preferable to use hydrophilic resins of synthetic polymer substances such as polyvinyl alcohol (PVA), PVA crosslinked polymers, PVA water-absorbing gel freeze-thaw elastomers, and polyvinyl alcohol copolymers.

[0032] It is preferable that a portion of the connecting portion 50 (preferably the distal end) is inserted into the lumen 11 of the coil 10. It is preferable that a portion of the connecting portion 50 (preferably the proximal end) extends proximal to the proximal end of the coil 10.

[0033] The shape of the connecting portion 50 is not particularly limited and may be linear, rod-shaped, cylindrical, polygonal prism-shaped, cylindrical, polygonal tube-shaped, frustoconical, frustoconical, or a combination thereof.

[0034] As shown in Figures 1 and 2, the coil 10 is constructed by winding a wire 21, and the implantation device 1 may further have a tip 25 positioned at the distal end of the coil 10. The tip 25 covers a portion of the wire 21 to prevent the distal end of the wire 21 from directly contacting the inner wall surface of the body. The tip 25 may or may not be in contact with the stretch resistance member 30.

[0035] The shape of the tip 25 is not particularly limited, but may be, for example, hemispherical, semi-elongated, cylindrical, or polygonal prism.

[0036] The tip 25 may be joined to at least one of the outer circumferential surface 12 and the inner circumferential surface 13 of the coil 10. In addition, to prevent the tip 25 from falling off, a portion of the tip 25 may be placed in the lumen 11 at the distal end of the coil 10. The proximal end of the tip 25 may be located distal to the distal end of the wire 21, and vice versa.

[0037] The tip 25 may be made of a metal material or a resin. Examples of resins that make up the tip 25 include thermoplastic resins and UV-curing resins. Examples of resins that make up the tip 25 include ester resins such as epoxy acrylate resins, urethane acrylate resins, polyester acrylate resins, and polyethylene terephthalate resins, and olefin resins such as polypropylene. As the metal that makes up the tip 25, the metals listed in the description of the wire 21 can be used. The materials of the wire 21 and the tip 25 may be the same or different.

[0038] As shown in Figures 1 and 2, a proximal tip 26 may be provided at the proximal end of the coil 10 to close the proximal end of the coil 10. The proximal tip 26 has a lumen, and a part of the connecting portion 50, such as the distal end, may be inserted into the lumen. For the configuration of the proximal tip 26, refer to the description of the tip 25.

[0039] As shown in Figure 2, a linear stretching resistance member 30 is arranged in the lumen 11. The stretching resistance member 30 suppresses the stretching of the coil 10 in the longitudinal axis direction x during operation.

[0040] The stretch resistance member 30 preferably has a longitudinal axis direction and has a first end and a second end in that longitudinal axis direction. The stretch resistance member 30 preferably extends from the distal end to the proximal end of the lumen 11.

[0041] The stretch resistance member 30 may be placed in the lumen 11 as a single unit, or multiple units may be placed therein.

[0042] The first end of the stretch resistance member 30 may be connected to the distal end of the coil 10, specifically to the distal end of the wire 21 that constitutes the coil 10. The second end of the stretch resistance member 30 may be connected to the proximal end of the coil 10, specifically to the proximal end of the wire 21. The second end of the stretch resistance member 30 may be connected to the connection part 50 that connects the coil 10 and the pusher 55. The configuration of the pusher 55 and the connection part 50 will be described later.

[0043] The stretch resistance member 30 may be positioned in the lumen 11 in a state where it is folded back in the middle of its longitudinal axis direction. In that case, it is preferable that the folded portion 30a of the stretch resistance member 30 is connected to the distal or proximal end of the coil 10, and the first end and the second end are connected to the proximal or distal end of the coil 10, or to the distal end of the connecting portion 50. For example, in Figure 2, the stretch resistance member 30 has a folded portion 30a that is folded back in the middle of its longitudinal axis direction, the folded portion 30a is connected to the distal end of the coil 10, and the first end and the second end are connected to the connecting portion 50.

[0044] The stretch resistance member 30 may be composed of a single member from the first end to the second end, or it may be composed of multiple members connected to each other in the longitudinal axis direction.

[0045] Methods for connecting the stretch resistance member 30 to other members include welding, crimping, adhesive bonding, engagement, linking, binding, ligation, and other physical fixing methods, or combinations thereof. Here, "connection" includes both forms in which the two elements are directly connected and forms in which the two elements are indirectly connected through one or more other elements.

[0046] The shape of the stretch resistance member 30 can be linear, for example, straight, wave-shaped, helical, or a combination thereof. A plane wave shape is preferred, and a sinusoidal wave shape is more preferred.

[0047] The shape of the cross-section of the stretch resistance member 30 perpendicular to the longitudinal axis may be circular, oval, polygonal, or a combination thereof, or it may be irregular in shape.

[0048] To facilitate the placement of the stretch resistance member 30 in the lumen 11, the outer diameter of the stretch resistance member 30 is preferably less than half the inner diameter of the coil 10, and more preferably one-third or less. To prevent the stretch resistance member 30 from breaking, the outer diameter of the stretch resistance member 30 is preferably one-fifteenth or more the inner diameter of the coil 10, and more preferably one-tenth or more.

[0049] The length of the stretch resistance member 30 can be set according to the length x in the longitudinal axis direction of the coil 10. Preferably, the length (path) of the stretch resistance member 30 is 110% or more, 120% or more, 150% or more, or 200% or more of the total length of the coil 10 (primary coil), and also preferably 250% or less, 230% or less, or 220% or less of the total length of the coil 10 (primary coil). This makes it possible to alleviate the tension caused by the end of the coil 10 stretching in a straight line due to insufficient length of the stretch resistance member 30 when the coil 10 is placed in the knot.

[0050] The length x in the longitudinal axis direction of the coil 10 is, for example, 1.0 cm or more and 50 cm or less. Therefore, the length of the extension resistance member 30 is, for example, 11 cm or more and 1.3 × 102 It can be less than or equal to cm.

[0051] As shown in Figures 3 and 4, the stretch-resistant member 30 has fibers 31 containing a polymer material 32 and a drug 33. By using fibers 31 containing the polymer material 32 and the drug 33 in the stretch-resistant member 30, it becomes easier to secure a large surface area of ​​the stretch-resistant member 30, and it becomes easier to release the drug 33 contained in the fibers 31.

[0052] The polymer contained in polymer material 32 may be a synthetic polymer or a natural polymer. Polymer material 32 also includes resins.

[0053] Generally, a fiber is a thin, thread-like substance, but in this specification, fiber 31 refers to a fiber with an average fiber diameter of 100 μm or less, and fibers with an average fiber diameter exceeding 100 μm are excluded. The average fiber diameter of fiber 31 can be measured by the following method: Obtain an image of the fiber at a magnification of 1000x using a scanning electron microscope or laser microscope (for example, a scanning transmission electron microscope (STEM-EDX / EELS) HD-2700 manufactured by Hitachi High-Technologies Corporation). The arithmetic mean of the diameters of at least 20 fibers measured in the obtained image is taken as the average fiber diameter. When measuring the fiber diameter, if the cross-sectional shape of the fiber is not circular, the average of the diameters of the circumcircle and incircle of the irregular cross-section is taken as the fiber diameter.

[0054] In order to provide the coil 10 with an elongation-inhibiting function, the average fiber diameter of the fibers 31 is preferably 20 μm or more, 25 μm or more, or 30 μm or more. Furthermore, from the viewpoint of ease of insertion into the lumen 11, the average fiber diameter of the fibers 31 is preferably 50 μm or less, 45 μm or less, or 40 μm or less.

[0055] A single fiber 31 may constitute a single stretch-resistant member 30. In that case, the shape of the cross-section of the stretch-resistant member 30 perpendicular to the longitudinal axis will directly represent the cross-section of the fiber 31 perpendicular to the longitudinal axis.

[0056] Multiple fibers 31 may constitute a single stretch-resistant member 30. The stretch-resistant member 30 may have multiple fibers 31 containing a polymer material 32 and a drug 33, or it may have a first fiber containing a first polymer material and a first drug, and a second fiber containing a second polymer material and a second drug. Alternatively, multiple fibers 31 connected to each other in the longitudinal axis direction may constitute a single stretch-resistant member 30. Figures 3 and 4 show an example in which the stretch-resistant member 30 is composed of a single fiber 31.

[0057] The stretch resistance member 30 may be composed of fiber bundles of multiple fibers. The form of the fiber bundles is not particularly limited and may be twisted, untwisted, or untwisted. The number of fibers in the fiber bundle may be, for example, 2 to 10.

[0058] Fiber 31 may be a hollow fiber, but it is preferable that it be a solid fiber. Fiber 31 may or may not have crimp. A crimped fiber is, for example, a solid fiber having a spiral-shaped three-dimensional crimp structure.

[0059] The average fiber length of fiber 31 can be set according to the number of fibers constituting the stretch-resistant member 30. If a single fiber constitutes a single stretch-resistant member 30, the average fiber length of the fiber is, for example, 1.1 × 10⁻¹⁰. 2 mm or more 1.3×10 3 It can be less than or equal to mm. When multiple fibers constitute a single stretch-resistant member 30, the average fiber length of the fibers is not particularly limited, but for example, 1.0 mm or more and 1.1 × 10 2 It can be less than or equal to mm.

[0060] The average fiber length of fiber 31 can be measured by the following method: Take 10 single fibers selected in descending order of length from the stretch-resistant member 30. Straighten each fiber without stretching it, measure its length (mm) on a measuring scale, and take the average of the measured lengths of the 10 fibers as the average fiber length of fiber 31. If the number of fibers constituting the stretch-resistant member 30 is less than 10, measure the fiber length of all the fibers constituting the stretch-resistant member 30, and take the average of the measured lengths as the average fiber length of fiber 31. If the number of fibers constituting the stretch-resistant member 30 is 1, take the fiber length of that 1 fiber as the average fiber length of fiber 31.

[0061] The fiber 31 can be formed using, for example, electrospinning, melt spinning, wet spinning, or dry spinning, and among these, it is preferable to form it using electrospinning.

[0062] The fiber 31 containing the polymer material 32 and the drug 33 is preferably present in an amount of 70% by mass or more (more preferably 90% by mass or more, and even more preferably 95% by mass or more) of 100% by mass of the stretch-resistant member.

[0063] The fiber 31 is preferably composed of a polymer composition containing a polymer material 32 and a drug 33, and more preferably composed solely of a polymer composition containing a polymer material 32 and a drug 33. The fiber 31 may also be composed of a resin composition containing a resin and a drug 33, or it may be composed solely of a resin composition containing a resin and a drug 33. Having such a structure in the fiber 31 allows for a gradual release rate of the active ingredient of the drug 33 while ensuring the function of suppressing the elongation of the coil 10 by the fiber 31.

[0064] As can be seen from Figures 3 and 4, it is preferable that the stretch-resistant member 30 is composed only of fibers 31 containing the polymer material 32 and the drug 33. In other words, it is preferable that the stretch-resistant member 30 consists of fibers 31. It is preferable that the stretch-resistant member 30 does not contain any other materials besides the fibers 31, such as filamentous materials with an average fiber diameter of more than 100 μm, resin wires, metal wires, etc.

[0065] The polymer material 32 contained in the fiber 31 is preferably a biodegradable polymer material. As the biodegradable material decomposes, the surface area of ​​the stretch-resistant member 30 tends to increase, making it easier to release the drug 33 contained in the fiber 31. In this specification, a biodegradable polymer material refers to a material that has the property of being hydrolyzed in the body environment and, after decomposition, becomes a non-toxic low-molecular-weight substance that is metabolized.

[0066] The polymers contained in biodegradable polymer materials may be synthetic polymers or natural polymers, but synthetic polymers are preferred. Biodegradable polymer materials also include biodegradable resins. Examples of biodegradable polymer materials include polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), glycolic acid-lactide copolymer (PLGA), glycolic acid-ε-caprolactone copolymer, lactide-ε-caprolactone copolymer, glycolic acid-lactide-ε-caprolactone copolymer, poly(p-dioxanone) (PDO), poly(2-oxetanone), polymalic acid, polyhydroxyalkanoic acid (PHA), polyhydroxybutyrate (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PH Examples of these substances include, but are not limited to, BV, poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (PHBH), starches (carboxymethyl starch, dialdehyde starch), celluloses (CMC, MC, HEC, HPC), proteins (collagen, gelatin, glue, mixture of collagen and elastin), polysaccharides (glycosaminoglycans, chitin, chitosan, hyaluronic acid), gums (acacia gum, guar gum, tragacanth gum), fibroin, laminin, casein, polypeptides, tannins, lignin, alginic acid, etc. These may be used individually or in combination of two or more.

[0067] The polymer material 32 contained in the fiber 31 may be a non-biodegradable polymer material. This makes it less likely for decomposition to occur and less likely for the surface area of ​​the stretch-resistant member 30 to increase compared to the case of a biodegradable material, thus delaying the release timing of the drug 33 contained in the fiber 31. In this specification, a non-biodegradable polymer material refers to a material other than a biodegradable polymer material that is resistant to hydrolysis in the internal environment of the body.

[0068] The polymers contained in non-biodegradable polymer materials may be synthetic polymers or natural polymers, but synthetic polymers are preferred. Non-biodegradable polymer materials also include non-biodegradable resins. Examples of non-biodegradable polymer materials include, but are not limited to, vinyl acetate such as ethylene vinyl acetate, polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polyamides such as nylon, fluorine such as polyvinylidene fluoride and polytetrafluoroethylene, vinyl chloride such as acrylic and polyvinyl chloride, polycarbonate, epoxy, polyurethanes such as polyurethane elastomers, polyacrylonitrile, keratin, and silk fibroin. These may be used individually or in combination of two or more.

[0069] In addition to the materials mentioned above, the polymer material 32 may also contain various additives such as plasticizers, pigments, flame retardants, antistatic agents, lubricants, softeners, surfactants, and antibacterial agents.

[0070] The drug 33 contained in the fiber 31 may be the active ingredient (API) alone, or it may be a mixture with other additives. Preferred additives include base materials, plasticizers, stabilizers, surfactants, and the like.

[0071] The type of drug 33 contained in the fiber 31 is not particularly limited as long as it is necessary for the prevention or treatment of the affected area. Preferably, the drug 33 has at least one of the following effects: anti-inflammatory effect, antioxidant effect, antihypertensive effect, vasoconstriction inhibitory effect, anticoagulant effect, and shear stress sensing inhibitory effect, and more preferably, it has at least one of the following effects: anti-inflammatory effect, antioxidant effect, antihypertensive effect, and vasoconstriction inhibitory effect. Examples of drugs include selective serotonin reuptake inhibitors (SSRIs) (fluoxetine, sertraline, paroxetine, etc.), DPP-4 inhibitors (sitagliptin, linagliptin, alogliptin, etc.), HMG-CoA reductase inhibitors (atorvastatin, pitavastatin, rosuvastatin, pravastatin, simvastatin, fluvastatin, lovastatin, mevastatin, cerivastatin, etc.), nonsteroidal anti-inflammatory drugs (NSAIDs) (ibuprofen, naproxen, celecoxib, etc.), angiotensin II receptor blockers (ARBs) (losartan, valsartan, telmisartan, etc.), tocopherol acetate (vitamin E acetate, eviprostat, estrol, etc.), ascorbic acid (Asconal, Cinal, Cefylol), and edaravone (Radicut, Free Radical Scavenger). (e.g., jaber), N-acetyl-L-cysteine ​​(NAC), calcium channel blockers (amlodipine, nifedipine, diltiazem, etc.), diuretics (furosemide, trichlormethiazide, spironolactone, etc.), angiotensin-converting enzyme inhibitors (ACE inhibitors) (enalapril, lisinopril, perindopril, etc.), beta-blockers (metoprolol, atenolol, bisoprolol, etc.), alpha-blockers (prazosin, terazosin, doxamylase). Examples include zosyn, alpha-beta blockers (carvedilol, labetalol, butoxamine, etc.), nitrates (nitroglycerin, isosorbide dinitrate, etc.), prostacyclin analogs (epoprostenol, treprostinil, etc.), anticoagulants (heparin, heparin derivatives, warfarin, antithrombin drugs such as dabigatran, rivaroxaban, etc.), and antiplatelet agents (aspirin, clopidogrel, ticagrelor, etc.).

[0072] The drug 33 may be encapsulated in a capsule. The size of the capsule is preferably 10 nm or larger, more preferably 50 nm or larger, even more preferably 100 nm or larger, and preferably 500 nm or smaller, more preferably 400 nm or smaller, and even more preferably 200 nm or smaller. The capsule is preferably made of a biodegradable material. As the biodegradable material, bioabsorbable polymers, natural polymers, decellularized biological tissues or cells, or combinations thereof can be used. As bioabsorbable polymers, at least one of polylactic acid (PLA), poly-L-lactic acid (PLLA), polyglycolic acid (PGA), copolymer of lactic acid and glycolic acid (PLGA), polycaprolactone (PCL), and polydioxanone (PDS) is preferably used. As natural polymers, at least one of collagen, laminin, fibroin, gelatin, glycosaminoglycan, chitin, chitosan, hyaluronic acid, and polypeptide is preferably used.

[0073] The stretch resistance member 30 may contain biodegradable materials other than polymer materials. Examples of such materials include biodegradable alloys such as magnesium alloys and iron-manganese alloys. A portion of the fiber 31 may be composed of a biodegradable alloy.

[0074] The stretch resistance member 30 may contain an X-ray opaque material. Examples of X-ray opaque materials include lead, barium, iodine, tungsten, gold, silver, platinum, iridium, platinum-iridium alloy, stainless steel, titanium, cobalt-chromium alloy, palladium, and tantalum.

[0075] The fiber 31 may contain an X-ray opaque material. For example, the X-ray opaque material may be coated on the surface of the fiber 31, or the X-ray opaque material may be encapsulated within the fiber 31.

[0076] In addition to the materials mentioned above, the fiber 31 may also contain various additives such as plasticizers, pigments, flame retardants, antistatic agents, lubricants, softeners, and surfactants.

[0077] As shown in Figure 3, it is preferable that the polymer material 32 and the drug 33 are mixed in the fiber 31. The drug 33 may be dispersed in the polymer material 32 in the fiber 31. The drug 33 may be uniformly dispersed in the polymer material 32 or dispersed locally. The drug 33 may be dispersed in the polymer material 32 in particulate form. The drug 33 may be exposed on the surface of the fiber 31 or may be present only inside the fiber 31. In the fiber 31, the polymer material 32 may function as a matrix. In the fiber 31, the drug 33 may be dissolved in the polymer material 32.

[0078] The fiber 31 shown in Figure 3 can be produced, for example, by mixing (preferably kneading) a polymer material and a chemical agent. For production, a spinning system equipped with an extruder and a spinneret may be used, for example. The polymer material and chemical agent can be mixed (preferably kneaded) in the extruder, the mixture can be melted, and the mixture can be extruded from the spinneret to produce the fiber 31.

[0079] In the fiber 31, the mixing ratio of polymer material 32 to drug 33 is preferably 1 / 1 or more by mass, more preferably 2 / 1 or more, even more preferably 3 / 1 or more, and also preferably 100 / 1 or less, more preferably 80 / 1 or less, and even more preferably 50 / 1 or less.

[0080] In the fiber 31, the content of the polymer material 32 is preferably 20 wt% or more, more preferably 30 wt% or more, even more preferably 40 wt% or more, and preferably 80 wt% or less, more preferably 70 wt% or less, and even more preferably 60 wt% or less.

[0081] In the fiber 31, the content of the drug 33 is preferably 20 wt% or more, more preferably 30 wt% or more, even more preferably 40 wt% or more, and preferably 80 wt% or less, more preferably 70 wt% or less, and even more preferably 60 wt% or less.

[0082] In the fiber 31, when the drug 33 is dispersed in particulate form within the polymer material 32, the particle size is not particularly limited, but may be, for example, 10.0 nm or larger, 50.0 nm or larger, 100 nm or larger, or 200 nm or larger. Alternatively, the particle size may be 5.0 μm or smaller, 4.0 μm or smaller, 3.00 μm or smaller, 2.00 μm or smaller, or 1.00 μm or smaller. Having the particle size within the above range makes it easier to uniformly disperse the particulate drug 33 in the polymer material 32, and also facilitates the manufacturing of the fiber 31. Here, "particle size" refers to the volume-average particle size (D50) at the median 50% diameter in the particle size distribution obtained by dynamic light scattering or the like. Commercially available particulate drugs may be used, in which case the particle size listed in the catalog can be adopted.

[0083] The fiber 31 may be a composite fiber having a core-sheath structure, an eccentric structure, or a side-by-side structure. In order to slow down the release rate of the active ingredient of the drug 33 from the fiber 31, it is preferable that the drug 33 is encapsulated in the polymer material 32 within the fiber 31. Encapsulating the drug 33 in the polymer material 32 means that the drug 33 is covered by the polymer material 32 and is not exposed to the outside. By covering the drug 33 with the polymer material 32, the occurrence of an initial burst of the drug 33 can be suppressed, and the release rate of the active ingredient of the drug 33 can be easily controlled.

[0084] As shown in Figure 4, the fiber 31 preferably includes a core-sheath type fiber having a core portion 34 and a sheath portion 35, with the core portion 34 containing the drug 33 and the sheath portion 35 containing a polymer material 32. More preferably, the fiber 31 consists of a core-sheath type fiber having a core portion 34 and a sheath portion 35, with the core portion 34 containing the drug 33 and the sheath portion 35 containing a polymer material 32. By using a composite fiber of this shape, it becomes easier to suppress the occurrence of an initial burst of the drug 33 and to control the release rate of the active ingredient of the drug 33.

[0085] In the core portion 34, the content of polymer material is preferably 20 wt% or less, more preferably 10 wt% or less, and even more preferably 5 wt% or less, and it is even more preferable that the core portion 34 does not contain polymer material. In the sheath portion 35, the content of the drug is preferably 20 wt% or less, more preferably 10 wt% or less, and even more preferably 5 wt% or less, and it is even more preferable that the sheath portion 35 does not contain the drug.

[0086] The stretch resistance member 30 is preferably made up of one or more core-sheath type fibers.

[0087] Examples of composite fiber structures include concentric core sheath type, eccentric core sheath type, and sea-island type. However, to facilitate control of the release rate of the active ingredient of the drug, the concentric core sheath type is preferred.

[0088] The core-sheath type fiber contained in fiber 31 can be manufactured in the same manner as general core-sheath type fibers. For manufacturing, for example, an electrospinning system equipped with a spinneret and collector having a multi-tube shape may be used. Preferably, the core material supplied to the system contains a drug 33, and the sheath material contains a polymer material 32. The core material may contain a solvent that is soluble in the drug 33. The sheath material may also contain a solvent that is soluble in the polymer material 32. The solvent is not particularly limited as long as it can dissolve the polymer material 32 and / or the drug 33 and can be sprayed from the spinneret. Examples of solvents include water, N,N-dimethylformamide (DMF), ethanol, acetone, tetrahydrofuran, chloroform, dichloromethane, ethyl acetate, toluene, and the like.

[0089] As can be seen from Figure 2, the stretch resistance member 30 may be composed of a single type of fiber 31 from its distal end to its proximal end. For example, the stretch resistance member 30 may be composed only of fibers 31 containing a biodegradable polymer material and a drug, or it may be composed only of fibers 31 containing a non-biodegradable polymer material and a drug.

[0090] The stretch resistance member 30 may include a first linear member 36 and a second linear member 37 arranged parallel to each other in the lumen 11 of the coil 10. Here, the first linear member 36 and the second linear member 37 may represent a portion and another portion of a single linear member, as shown in Figure 2, or they may represent two independent linear members, as shown in Figure 5. If the first linear member 36 and the second linear member 37 are two independent linear members, they may be connected to each other at any position. For example, it is preferable that the distal end of the first linear member 36 and the distal end of the second linear member 37 are connected to each other at the distal portion of the coil 10. As shown in Figure 5, the connection between the first linear member 36 and the second linear member 37 may be located at the folded portion 30a of the stretch resistance member 30.

[0091] The statement that the first linear member 36 and the second linear member 37 are arranged parallel to each other means that the extending direction of the first linear member 36 and the extending direction of the second linear member 37 are parallel as a whole, and the longitudinal axis direction of the first linear member 36 and the longitudinal axis direction of the second linear member 37 may be in different directions. Furthermore, the first linear member 36 and the second linear member 37 only need to be arranged parallel to each other in at least a portion of the longitudinal axis direction x of the coil 10, and do not need to be arranged parallel to each other over the entire longitudinal axis direction x of the coil 10.

[0092] The first linear member 36 and the second linear member 37 may have different shapes. For example, the first linear member 36 may have a straight shape, and the second linear member 37 may have a wave shape.

[0093] In the stretch resistance member 30, the first linear member 36 is preferably made of fibers containing a biodegradable polymer material and a drug, and more preferably made of fibers in which the drug is mixed with the biodegradable polymer material. The first linear member 36 is preferably made of fibers containing a biodegradable polymer material and a drug, but not containing a non-biodegradable polymer material. The first linear member 36 is preferably made of fibers containing a biodegradable polymer material and a drug, but not containing a non-biodegradable polymer material. The second linear member 37 is preferably made of fibers containing a non-biodegradable polymer material and a drug, and more preferably made of fibers in which the drug is mixed with the non-biodegradable polymer material. The second linear member 37 is more preferably made of fibers containing a non-biodegradable polymer material and a drug, but not containing a biodegradable polymer material. This makes it possible to make the functions of the fibers different in the first linear member 36 and the second linear member 37, so that the release rate of the drug 33 from the first linear member 36 and the release rate of the drug 33 from the second linear member 37 can be changed. This makes it easier to stagger the timing of drug release 33, thereby improving the sustained release properties of the drug.

[0094] It is preferable that the drug release rate from the first linear member 36 is faster than the drug release rate from the second linear member 37.

[0095] The active ingredients of the drug 33 contained in the first linear member 36 and the active ingredients of the drug 33 contained in the second linear member 37 may be the same or different.

[0096] For the composition of the fibers of the first linear member 36 and the second linear member 37, refer to the description of the fibers 31 described above.

[0097] Although not shown in the diagram, the drug may be placed on the surface of the coil 10. The drug may be placed on the outer circumferential surface 12 of the coil 10, or on the inner circumferential surface 13 of the coil 10. The drug placed on the surface of the coil 10 may be held on the surface of the coil 10 as a drug layer.

[0098] The drug may be directly attached to the surface of the coil 10, or it may be attached indirectly to the surface of the coil 10 via a bioadhesive. The type of material of the bioadhesive is not particularly limited, but for example, polysaccharide adhesives such as collagen, chitosan, and gelatin, polyethylene glycol-based hydrogel adhesives, and protein adhesives such as fibrin and collagen can be used.

[0099] The drug to be placed on the surface of the coil 10 is preferably encapsulated in a capsule. The drug encapsulated in the capsule may be directly attached to the surface of the coil 10, or it may be attached indirectly to the surface of the coil 10 via a bioadhesive. The size of the capsule is preferably 10 nm or larger, more preferably 50 nm or larger, even more preferably 100 nm or larger, and preferably 500 nm or smaller, more preferably 400 nm or smaller, and even more preferably 200 nm or smaller. The capsule preferably contains a biodegradable material.

[0100] In order to facilitate the coil stretching suppression function of the stretching resistance member 30, it is preferable that the drug is not filled in such a way that it blocks the lumen 11 of the coil 10.

[0101] The agent may be placed on the surface of the stretch-resistance member 30. This allows the stretch-resistance member 30 to hold more of the agent. The agent may be placed only on a portion of the stretch-resistance member 30 in the longitudinal direction, or it may be placed along the entire longitudinal direction of the stretch-resistance member 30. For a method of providing the agent on the surface of the stretch-resistance member 30, refer to the description of a method for providing the agent on the surface of the coil 10.

[0102] As shown in Figures 1, 2, 5, and 6, the indwelling device 1 is positioned proximal to the coil 10 in the longitudinal direction x, and may further include a pusher 55 that pushes the coil 10 distally, and a connecting portion 50 that connects the proximal portion of the coil 10 and the distal portion of the pusher 55.

[0103] The pusher 55 is a rod-shaped or wire-shaped member used to hold the indwelling device 1 and push it distally. The pusher 55 can consist of one or more members. The pusher 55 can consist of a wire member, a coil member, or a combination thereof. The pusher 55 can be made of a conductive material such as stainless steel.

[0104] The implantation device 1 preferably has a detachment mechanism that detaches the coil 10 from the pusher 55. Examples of detachment mechanisms include hydraulic, electric, and mechanical types, and among these, an electric detachment mechanism is preferred. In the detachment mechanism, it is preferable that the connection portion 50 is heated and disconnected by electrical or thermal energy supplied through the pusher 55, thereby detaching the coil 10 from the pusher 55. In this case, it is preferable that the connection portion 50 is heated by a high-frequency current supplied between the distal end of the pusher 55 and the counter electrode.

[0105] The shape of the connecting portion 50 is not particularly limited and may be linear, rod-shaped, cylindrical, polygonal prism-shaped, cylindrical, polygonal tube-shaped, frustoconical, frustoconical, or a combination thereof.

[0106] The connecting portion 50 preferably contains a material that melts or dissolves when heated. The connecting portion 50 can be cut by Joule heating. Examples of such materials include synthetic resin materials, and it is preferable to use hydrophilic resins of synthetic polymers such as polyvinyl alcohol (PVA), PVA crosslinked polymers, PVA water-absorbing gel freeze-thaw elastomers, and polyvinyl alcohol copolymers.

[0107] In the extension resistance member 30, if the first linear member 36 is made of fibers 31 containing a biodegradable polymer material and a drug, and the second linear member 37 is made of fibers 31 containing a non-biodegradable polymer material and a drug, it is preferable that, as shown in Figure 5, the first linear member 36 and the second linear member 37 are fixed to the distal end and the connection part 50 of the coil 10, respectively. For example, it is preferable that the first linear member 36 and the second linear member 37 each have a first end and a second end in the longitudinal axis direction, the first end of the first linear member 36 and the first end of the second linear member 37 are fixed to the distal end of the coil 10, and the second end of the first linear member 36 and the second end of the second linear member 37 are fixed to the connection part 50, respectively. By fixing the first linear member 36 and the second linear member 37 in this manner, they become less prone to bending, and the surfaces of the first linear member 36 and the second linear member 37 are more easily exposed, making it easier to control the timing of drug release.

[0108] As shown in Figure 6, the implantation device 1 is positioned in a lumen 11 and may further have an internal wire 40 having fibers containing a polymer material and a drug. In that case, it is preferable that the stretch resistance member 30 is fixed to the distal end and connection part 50 of the coil 10, and that both the first and second ends in the longitudinal axis direction of the internal wire 40 are not fixed to any other member. Because the internal wire 40 is positioned in the lumen 11, the drug necessary for treatment can be released not only from the stretch resistance member 30 but also from the internal wire 40.

[0109] The internal wire 40 is a linear component with a longitudinal axis direction. The internal wire 40 has a first end and a second end in the longitudinal axis direction. The internal wire 40 has the function of holding the drug within the coil 10 and releasing the drug after the coil 10 is inserted into the body. Because the internal wire 40 has fibers containing a polymer material and a drug, it is easier to secure a large surface area of ​​the internal wire 40, making it easier to release the drug contained in the fibers.

[0110] Either the first or second end of the internal wire 40 may be fixed to another member. For example, the first end of the internal wire 40 may be fixed to the distal end of the coil 10, or the second end of the internal wire may be fixed to the connection part 50.

[0111] It is preferable that the internal wire 40 is not fixed to the coil 10. It is preferable that the internal wire 40 is not fixed to the connection part 50. It is preferable that the internal wire 40 is not fixed to the tip 25 or the base tip 26. Furthermore, it is preferable that the internal wire 40 is not fixed to any other member. By having fewer or no fixed parts, the drug can be easily released from the internal wire 40.

[0112] The internal wire 40 may be movable relative to the coil 10.

[0113] The internal wire 40 is preferably composed only of fibers containing polymer material and pharmaceuticals. In other words, the internal wire 40 is preferably made of fibers. The internal wire 40 is preferably free of components other than fibers, such as thread-like materials with an average fiber diameter of more than 100 μm, resin wires, metal wires, etc.

[0114] The internal wire 40 may be placed in the lumen 11 as a single unit, or multiple units may be placed therein.

[0115] The shape of the internal wire 40 is not particularly limited, but can be, for example, linear, wave-shaped, helical, or a combination thereof. A plane wave shape is preferred, and a sinusoidal wave shape is more preferred. The shape of the internal wire 40 may be the same as, or different from, the shape of the stretch resistance member 30.

[0116] The cross-sectional shape of the internal wire 40 perpendicular to the longitudinal axis may be circular, oval, polygonal, a combination thereof, or irregular. The cross-sectional shape of the internal wire 40 may be the same as the cross-sectional shape of the stretch-resistant member 30. It is preferable that the cross-sectional shape of the internal wire 40 differs from the cross-sectional shape of the stretch-resistant member 30 in order to stagger the timing of drug release between the internal wire 40 and the stretch-resistant member 30.

[0117] The average fiber diameter of the fibers constituting the internal wire 40 is not particularly limited, but is preferably 20 μm or more, 25 μm or more, or 30 μm or more. Furthermore, from the viewpoint of ease of insertion into the lumen 11, the average fiber diameter of the fibers constituting the internal wire 40 is preferably 100 μm or less, 80 μm or less, or 50 μm or less. The average fiber diameter of the fibers constituting the internal wire 40 may be the same as the average fiber diameter of the fibers constituting the stretch-resistant member 30. In order to stagger the timing of drug release between the internal wire 40 and the stretch-resistant member 30, it is preferable that the average fiber diameter of the fibers constituting the internal wire 40 is larger or smaller than the average fiber diameter of the fibers constituting the stretch-resistant member 30. The average fiber diameter of the fibers constituting the internal wire 40 can be measured in the same way as the average fiber diameter of the fibers constituting the stretch-resistant member 30.

[0118] A single fiber may constitute a single internal wire 40, or multiple fibers may constitute a single internal wire 40. The internal wire 40 may have multiple fibers containing a polymer material and a drug, or it may have a first fiber containing a first polymer material and a first drug, and a second fiber containing a second polymer material and a second drug. Alternatively, multiple fibers connected to each other in the longitudinal axis direction may constitute a single internal wire 40. The internal wire 40 may be composed of fiber bundles of multiple fibers. The form of the fiber bundle is not particularly limited and may be twisted, untwisted, or untwisted. The number of fibers in the fiber bundle may be, for example, 2 to 10.

[0119] Preferably, either the stretch-resistant member 30 or the internal wire 40 is made of a fiber containing a biodegradable polymer material and a drug, and the other is made of a fiber containing a non-biodegradable polymer material and a drug. Preferably, either the stretch-resistant member 30 or the internal wire 40 is made of a fiber containing a biodegradable polymer material and a drug, but not a non-biodegradable polymer material, and the other is made of a fiber containing a non-biodegradable polymer material and a drug, but not a biodegradable polymer material. Since the release rate of the drug from the stretch-resistant member 30 and the release rate of the drug from the internal wire 40 can be changed, it becomes easier to stagger the timing of drug release, making it easier to improve the sustained release of the drug. For example, in order to accelerate the release of the drug from the stretch-resistant member 30 compared to the internal wire 40, it is preferable that the stretch-resistant member 30 is made of fibers containing a biodegradable polymer material and the drug, and the internal wire 40 is made of fibers containing a non-biodegradable polymer material and the drug. It is even more preferable that the stretch-resistant member 30 is made of fibers containing a biodegradable polymer material and the drug but not a non-biodegradable polymer material, and the internal wire 40 is made of fibers containing a non-biodegradable polymer material and the drug but not a biodegradable polymer material.

[0120] Either the stretch-resistant member 30 or the internal wire 40 may be a fiber in which a drug is mixed with a polymer material, and the other may include a core-sheath type fiber having a core and a sheath, where the core contains the drug and the sheath contains the polymer material. For example, in order to accelerate the release of the drug from the stretch-resistant member 30 compared to the internal wire 40, it is preferable that the stretch-resistant member 30 is a fiber in which a drug is mixed with a polymer material, and the internal wire 40 is a core-sheath type fiber in which the core contains the drug and the sheath contains the polymer material.

[0121] For further details regarding the configuration of the internal wire 40, please refer to the explanation of the configuration of the stretch resistance member 30. [Explanation of Symbols]

[0122] 1: Intra-vivo device 10: Coil 11:Lumen 12: Outer surface 13: Inner surface 21: Wire rod 25: Tip 26: Base tip 30: Stretch resistance member 30a: Folded section 31: Fibers 32: Polymer material 33: Medications 34: Core part 35: Scabbard part 36: First linear member 37: Second linear member 40: Internal lines 50: Connection part 55: Pusher x: Longitudinal axis of the coil y: radial direction of the coil z: Circumferential direction of the coil

Claims

1. A coil having a lumen, An in-vivo implant comprising a linear stretch-resistant member disposed within the lumen and having fibers containing a polymer material and a drug.

2. The in-vivo implantation device according to claim 1, wherein the stretch-resistant member is composed solely of the fibers.

3. The in-vivo device according to claim 1 or 2, wherein the fiber contains a mixture of the polymer material and the drug.

4. The in-vivo implantation device according to claim 1 or 2, wherein the drug is encapsulated within the polymer material in the fiber.

5. The in-vivo implantation device according to claim 4, wherein the fiber includes a core-sheath type fiber having a core portion and a sheath portion, the core portion containing the drug, and the sheath portion containing the polymer material.

6. The in-vivo implantation device according to claim 1 or 2, wherein the polymer material is a biodegradable polymer material.

7. The in-vivo implantation device according to claim 1 or 2, wherein the polymer material is a non-biodegradable polymer material.

8. The stretch resistance member includes a first linear member and a second linear member arranged parallel to each other within the lumen, The first linear member is made of fibers containing a biodegradable polymer material and a drug, The in-vivo implantation device according to claim 1 or 2, wherein the second linear member is made of fibers containing a non-biodegradable polymer material and a drug.

9. The in-vivo implantation device further comprises a pusher positioned proximal to the coil in the longitudinal axis direction of the coil and pushing the coil distally, and a connecting portion connecting the proximal portion of the coil and the distal portion of the pusher. The in-vivo implantation device according to claim 8, wherein the first linear member and the second linear member are fixed to the distal end of the coil and the connecting portion, respectively.

10. The in-vivo implantation device is positioned within the lumen and further has an internal wire having fibers containing a polymer material and a drug, The in-vivo implantation device according to claim 1 or 2, wherein the internal wire is not fixed to the coil.

11. The in-vivo implantation device further comprises a pusher positioned proximal to the coil in the longitudinal axis direction of the coil and pushing the coil distally, and a connecting portion connecting the proximal portion of the coil and the distal portion of the pusher. The stretch resistance member is fixed to the distal end of the coil and the connection portion. The in-vivo implantation device according to claim 10, wherein the internal wire is not fixed to the connection portion.

12. The in-vivo implantation device according to claim 10, wherein either the stretch resistance member or the internal wire is made of a fiber containing a biodegradable polymer material and a drug, and the other is made of a fiber containing a non-biodegradable polymer material and a drug.

Images