Method for producing living body indwelling object

Abstract

To provide a method for producing a living body indwelling object capable of stably fixing a porous structure to a stent.SOLUTION: The method for producing a living body indwelling object 100 includes a disposing step S01 of disposing a porous structure fixing material 50 and a porous structure 20 having a knitted stitch structure on a stent 10 extending in an axial direction and formed to be capable of inflating in a radial direction, and a fixing step S04 of fixing the porous structure to the stent by melting the porous structure fixing material.SELECTED DRAWING: Figure 16

Description

[Technical field]

[0001] The present invention relates to a method for producing a living body indwelling. [Background technology]

[0002] A stent is a medical device that is delivered to a lesion in a biological lumen by a stent delivery system and then placed to expand the lesion such as a stenosis or occlusion and secure the lumen in order to treat various diseases caused by the narrowing or occlusion of a biological lumen such as a blood vessel. A stent has linear rings that form the outer periphery of a cylindrical shape with gaps, and multiple links that connect the rings with gaps.

[0003] For example, the following Patent Document 1 discloses a stent device in which a porous structure is disposed on the surface of a support element in order to prevent peripheral embolism during stent placement. The stent device is capable of preventing the scattering of thrombus due to the expansion of the support element by the porous structure expanding in response to the expansion of the support element. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] WO2006 / 126182 Summary of the Invention [Problem to be solved by the invention]

[0005] Generally, when a porous structure, which has an indefinite shape and is delicate, is fixed to a support element (stent), the shape of the porous structure is distorted, making stable attachment difficult.

[0006] The present invention has been made in view of the above-mentioned problems, and an object of the present invention is to provide a method for producing an in-vivo indwelling device, which is capable of stably fixing a porous structure to a stent. [Means for solving the problem]

[0007] The above object of the present invention can be achieved by the following means.

[0008] (1) a placement step of placing a porous structure having a large number of voids passing therethrough and a porous structure fixing material on a stent formed to extend in an axial direction and be expandable in a radial direction; and a fixing step of melting the porous structure fixing material to fix the porous structure to the stent.

[0009] (2) The method for producing a living body indwelling device according to (1), wherein in the positioning step, after the porous structure fixing material is placed on the stent, the porous structure is placed on a surface of the porous structure fixing material.

[0010] (3) The method for producing a living body indwelling device according to (1) or (2), wherein in the arranging step, the porous structure fixing material is arranged so as to form a gently sloping shape in a cross-sectional view.

[0011] (4) The method for producing a living body indwelling device according to any one of (1) to (3), wherein in the fixing step, the porous structure is embedded inside the porous structure fixing material.

[0012] (5) The method for producing a living body indwelling device according to any one of (1) to (4), wherein the porous structure fixing material is made of a material selected from the group consisting of polymers and waxes.

[0013] (6) The method for producing a living body indwelling device according to any one of (1) to (5), wherein a material constituting the porous structure fixing material has a lower melting point than a material constituting the porous structure.

[0014] (7) The method for producing a living body indwelling device according to any one of (1) to (6), wherein in the placing step, the porous structure fixing material is placed on a part of the stent.

[0015] (8) The stent is A linear ring that forms the outer periphery of a cylindrical shape with a gap formed therein; a plurality of link portions connecting the rings to each other at the gaps; The method for producing a living body indwelling device according to any one of (1) to (7), wherein in the arranging step, the porous structure fixing material is arranged on at least one of the plurality of link parts.

[0016] (9) The stent has an outer surface formed with a drug-coated layer and an exposed portion not coated with a drug, The method for producing a living body indwelling device according to any one of (1) to (8), wherein in the placing step, the porous structure fixing material is placed on the exposed portion.

[0017] (10) The method for producing a living body indwelling device according to any one of (1) to (9), wherein the porous structure is formed by knitting.

[0018] (11) A method for manufacturing a living body indwelling device, comprising the steps of: fixing a porous structure having a large number of through-holes to a stent that is formed to extend in an axial direction and be expandable in a radial direction, the method comprising the steps of: A method for manufacturing a biological indwelling device, comprising pressing a porous structure fixing material placed on the stent and the porous structure toward the stent with a pressing body, melting the porous structure fixing material, and welding the porous structure to the stent.

[0019] (12) The method for producing a living body indwelling device according to (11), wherein in the step of melting the porous structure fixing material, the porous structure fixing material is melted by a means selected from the group consisting of a laser, a light beam, heat, and ultrasonic waves.

[0020] (13) The pressing body has laser light transmissibility, The method for producing a living body indwelling device according to (11) or (12), wherein in the step of melting the porous structure fixing material, the porous structure fixing material is irradiated with laser light via the pressing body.

[0021] (14) The method for manufacturing a biological indwelling device according to (11) or (12), wherein in the step of melting the porous structure fixing material, the porous structure fixing material pressed by the pressing body and the stent in which the porous structure is disposed are heated. Effect of the Invention

[0022] According to the above-mentioned method for manufacturing a biological indwelling device, in the positioning step, the porous structure fixing material and the porous structure are placed on the stent, and then in the fixing step, the porous structure fixing material is melted to fix the porous structure to the stent, so that the porous structure can be stably fixed to the stent. [Brief description of the drawings]

[0023] [Figure 1] FIG. 1 is a schematic plan view showing a stent delivery system including a living body indwelling device according to an embodiment of the present invention. [Diagram 2] FIG. 2 is a schematic plan view showing a reduced diameter state of the living body indwelling device according to the present embodiment. [Diagram 3] FIG. 2 is a schematic plan view showing an expanded diameter state of the living body indwelling device according to the present embodiment. [Figure 4] FIG. 2 is a partially enlarged view showing the living body indwelling device according to the present embodiment. [Diagram 5] FIG. 5 is a partially enlarged view showing part A in FIG. [Figure 6] FIG. 6 is a partially enlarged view showing part A in FIG. 5. [Figure 7A] FIG. 7 is a cross-sectional view taken along line 7A-7A in FIG. 6. [Figure 7B]FIG. 7 is a cross-sectional view taken along line 7B-7B in FIG. 6. [Figure 8] FIG. 2 is a schematic plan view showing the vicinity of the tip of the living body indwelling device according to the present embodiment. [Figure 9] FIG. 9 is a partially enlarged view showing part A in FIG. 8. [Figure 10] The two-dot chain line indicates the shape of the stent when it is contracted, and the solid line indicates the shape of the stent when it is expanded. [Figure 11] FIG. 2 is a flowchart showing a method for manufacturing a living body indwelling device according to the present embodiment. [Figure 12] FIG. 4 is a view for explaining the state in which a porous structure fixing material is placed on a stent in the placement step of the manufacturing method of the living body indwelling device according to the present embodiment, and corresponds to FIG. 3. [Figure 13] FIG. 7B is a cross-sectional view illustrating the arrangement of a porous structure in the arrangement step of the manufacturing method of a living body indwelling device according to the present embodiment, and corresponds to FIG. 7A. [Figure 14] FIG. 7B is a cross-sectional view for explaining a pressing step in the method for producing a living body indwelling device according to the present embodiment, and corresponds to FIG. 7A. [Figure 15] FIG. 7B is a cross-sectional view for explaining a fixing step in the method for producing a living body indwelling device according to the present embodiment, and corresponds to FIG. 7A. [Figure 16] 16 is a diagram illustrating a state in which the pressing body and the core bar are removed from FIG. 15. FIG. [Figure 17] FIG. 5 is a view corresponding to FIG. 4 and showing a living body indwelling device according to a modified example. [Figure 18] FIG. 13 is a schematic diagram showing a stent according to a modified example. [Figure 19] FIG. 13 is a schematic diagram showing a stent according to a modified example. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] Hereinafter, an embodiment of the present invention will be described with reference to the attached drawings. Note that the following description does not limit the technical scope or meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for the convenience of explanation and may differ from the actual ratios.

[0025] Hereinafter, the configuration of the living body indwelling device 100 according to the present embodiment will be described with reference to Figs. 1 to 11. Fig. 1 is a schematic plan view showing a stent delivery system 300 including the living body indwelling device 100 according to the embodiment of the present invention. Fig. 2 is a schematic plan view showing the living body indwelling device 100 according to the present embodiment in a contracted state. Fig. 3 is a schematic plan view showing the living body indwelling device 100 according to the present embodiment in an expanded state. Fig. 4 is a partial enlarged view showing the living body indwelling device 100 according to the present embodiment. Fig. 5 is a partial enlarged view showing part A in Fig. 4. Fig. 6 is a partial enlarged view showing part A in Fig. 5. Fig. 7A is a cross-sectional view taken along line 7A-7A in Fig. 6. Fig. 7B is a cross-sectional view taken along line 7B-7B in Fig. 6. Fig. 8 is a schematic plan view showing the vicinity of the tip of the living body indwelling device 100 according to the present embodiment. Fig. 9 is a partial enlarged view showing part A in Fig. 8. In Fig. 10, the two-dot chain line shows the shape of the stent 10 when contracted, and the solid line shows the shape of the stent 10 when expanded.

[0026] In this specification, the left-right direction in Fig. 2 is referred to as the "axial direction" of the living body indwelling device 100, and the up-down direction in Fig. 2 is referred to as the "radial direction" of the living body indwelling device 100. In addition, the side inserted into the living body is referred to as the "distal side", and the side opposite the distal side where the surgeon operates the medical device is referred to as the "proximal side".

[0027] <100 living body specimens> As shown in FIG. 1, the indwelling device 100 according to this embodiment is disposed on the outer periphery of a balloon 220 of a balloon catheter 200 to constitute a stent delivery system 300.

[0028] The balloon catheter 200 is used to deliver the indwelling device 100 in a contracted state to the affected area and to expand it to place it at the affected area.

[0029] The balloon catheter 200 has a long catheter main body 210, a balloon 220 provided at the tip of the catheter main body 210, and a hub 230 fixed to the base end of the catheter main body 210. Since the balloon catheter 200 has a known configuration, detailed description thereof will be omitted.

[0030] The configuration of the living body indwelling device 100 will be described below with reference to Figs. 2 to 9. The living body indwelling device 100 according to this embodiment is used to treat stenosis or obstruction occurring in blood vessels, bile ducts, tracheas, esophagus, urethra, or other living body lumens. The living body indwelling device 100 is a so-called balloon expansion type device that is arranged in a crimped state on a folded balloon 220, and is expanded after being delivered to the lesion and placed at the lesion.

[0031] As shown in Figures 2 to 9, the in-vivo implant 100 has a stent 10 extending in the axial direction, a porous structure 20 arranged to cover the outer periphery of the stent 10, a fixing portion 30 at which the porous structure 20 is fixed to the stent 10, and both end fixing portions 40 at which the porous structure 20 is fixed to the stent 10 at the tip 10A and base end 10B of the stent 10.

[0032] Stent 10 extends in the axial direction (left-right direction in Figs. 2 and 3) and has a distal end 10A and a proximal end 10B. As shown in Figs. 2 and 3, stent 10 is formed so as to be capable of radial expansion (state shown in Fig. 3) and contraction (state shown in Fig. 2). As shown in Figs. 3 to 6, stent 10 has linear rings 11 that form the outer periphery of a cylindrical shape with gaps formed therein, and link portions 12 that connect rings 11 together via the gaps.

[0033] As shown in Figure 4, the wavy ring 11 has a plurality of first strut portions 15 which are straight or curved, a plurality of second strut portions 16 which are straight or curved, and a curved portion 17 formed between the first strut portions 15 and the second strut portions 16.

[0034] The rings 11 are arranged in sequence along the axial direction, and adjacent rings 11 in the axial direction are integrated together by link portions 12. Therefore, by increasing or decreasing the number of rings 11, a stent 10 of a desired length can be easily obtained.

[0035] As shown in Figures 6, 7A, and 7B, the outer surface of the stent 10 is formed with a drug-coated layer 18 coated with a drug and an exposed portion 19 not coated with a drug. The drug coated on the outer surface of the stent 10 is supported by a polymer to form the drug-coated layer 18. The polymer is preferably a biodegradable polymer. In this case, after the stent 10 is placed in the body, the drug is gradually released while the polymer is biodegraded, so that restenosis at the stent placement site is reliably prevented and inflammation caused by the polymer is suppressed.

[0036] The biodegradable polymer is, for example, at least one polymer selected from the group consisting of polyester, aliphatic polyester, polyanhydride, polyorthoester, polycarbonate, polyphosphazene, polyphosphate, polyvinyl alcohol, polypeptide, polysaccharide, protein, and cellulose, a copolymer in which the monomers constituting the polymer are arbitrarily copolymerized, and a mixture of the polymer and / or the copolymer. Examples of the aliphatic polyester include polylactic acid (PLA), polyglycolic acid (PGA), and lactic acid-glycolic acid copolymer (PLGA).

[0037] A drug coating layer 18 is disposed on the first strut portion 15 and the second strut portion 16 of the ring 11 shown in Figure 4, and on the outer surface of the ring 11 as shown in Figure 7B.

[0038] In other words, the curved portions 17 and link portions 12 of the ring 11 (areas where stress concentration and / or distortion occurs due to expansion deformation) are not coated with drug and no drug coating layer 18 is formed, so that stress concentration and / or distortion is avoided in the drug coating layer 18 even when the stent 10 is expanded.

[0039] A primer coating layer (not shown) may be disposed between drug coating layer 18 and the outer surface of stent 10. The primer constituting the primer coating layer is selected taking into consideration its adhesiveness to the polymer contained in drug coating layer 18 and its adhesiveness to the outer surface of stent 10, and the presence of the primer coating layer improves the peel resistance of drug coating layer 18.

[0040] The stent 10 is made of a metal material or a polymer material. When the stent 10 is made of a metal material, the metal material is not particularly limited, and any metal material that is normally used for the stent 10 can be used. Specific examples of the metal include stainless steels such as SUS304, SUS316, SUS316L, SUS420J2, and SUS630, tantalum, titanium, nickel-titanium alloys, tantalum-titanium alloys, nickel-aluminum alloys, Inconel, gold, platinum, iridium, tungsten, and cobalt-based alloys such as cobalt-chromium (Co-Cr) alloys.

[0041] Furthermore, when the stent 10 is made of a polymer material, the polymer material to be used is not particularly limited, and any polymer material that is usually used for stents can be used. Specific examples include polyolefins such as polyethylene and polypropylene, aromatic polyesters such as polyethylene terephthalate, cellulose-based polymers such as cellulose acetate and cellulose nitrate, and fluorine-containing polymers such as polytetrafluoroethylene and tetrafluoroethylene-ethylene copolymers.

[0042] The porous structure 20 is disposed so as to cover the outer periphery of the stent 10, and can expand in accordance with the expansion of the stent 10. By disposing the porous structure 20 on the outer periphery of the stent 10, the porous structure 20 is biased against the blood vessel by the stent 10 when the stent 10 is expanded in the blood vessel, so that the detachment of the porous structure 20 due to the pressure of the blood flow in the blood vessel is reduced. The porous structure 20 extends along the axial direction and has a knitted structure. The gaps of the knitted structure of the porous structure 20 are configured to be smaller than the gaps between the adjacent rings 11. With this configuration, when the stent 10 is placed, peripheral embolism during the expansion of the stent 10 can be prevented. In addition, the porous structure 20 has a large number of voids penetrating the stent 10. The size of the voids is preferably smaller in area than the gaps between the rings 11 of the stent 10. This can prevent the scattering of plaque and thrombus accompanying the expansion of the stent 10. On the other hand, the size of the voids is preferably larger in area than the individual blood cells contained in the blood. This allows blood cells to pass through the voids. Furthermore, the large number of penetrating voids gives the porous structure 20 an extensible property, so that when the stent 10 is expanded in the radial direction, the porous structure 20 also expands in the circumferential direction, making it easier to follow the expansion of the stent 10.

[0043] The porous structure 20 includes a knitted fabric, a woven fabric, and a molded product. When the porous structure 20 is a knitted fabric, the porous structure 20 is made of a knitted fabric. Since the knitted fabric is a known knitting method, detailed description will be omitted. By making the porous structure 20 of the knitted fabric, it is possible to suppress the axial shortening of the porous structure 20 accompanying the expansion of the stent 10. When the porous structure 20 is a woven fabric, the woven fabric is made of a known weaving method. The porous structure 20 may also be made of a molded product obtained by drilling holes in a cylindrical object formed by injection molding or the like. The size, shape, and number of the stitches and weaves of the porous structure 20 are not particularly limited as long as peripheral embolism during the expansion of the stent 10 can be prevented.

[0044] The material constituting the porous structure 20 is not particularly limited, but examples thereof include (1) polymers selected from the group consisting of aliphatic polyesters, polyesters, polyanhydrides, polyorthoesters, polycarbonates, polyphosphazenes, polyphosphates, polyvinyl alcohols, polypeptides, polysaccharides, proteins, and cellulose; and (2) copolymers composed of two or more types of monomers constituting the above (1). Here, the aliphatic polyester is not particularly limited, and examples thereof include polylactic acid (PLA) such as poly-L-lactic acid (PLLA), poly-D-lactic acid (PDLA), and poly-DL-lactic acid (PDLLA), polyglycolic acid (PGA), polyhydroxybutyric acid, polyhydroxyvaleric acid, polyhydroxypentanoic acid, polyhydroxyhexanoic acid, polyhydroxyheptanoic acid, poly(ε-caprolactone) (PCL), polytrimethylene carbonate, poly2,2-dimethyltrimethylene carbonate, polydioxanone, polybutyrolactone, polyvalerolactone, polymalic acid, polyethylene adipate, polyethylene succinate, polybutylene adipate, and polybutylene succinate. The polycarbonate is not particularly limited, and examples thereof include tyrosine-derived polycarbonate. Polymers other than the above-mentioned biodegradable polymers can also be used.

[0045] The porous structure 20 may be made of a metal material, in which case the same metal materials as those listed for the stent 10 described above can be used.

[0046] The thread diameter of the porous structure 20 is not particularly limited, but may be, for example, 20 μm.

[0047] Generally speaking, the fixing portion 30 fixes at least a portion of the porous structure 20 to the stent 10 at a position other than the distal end 10A and proximal end 10B of the stent 10. In this specification, the distal end 10A of the stent 10 is defined as "the most distal end of the stent 10, in which the link portion 12 arranged at the most distal end is not provided." Also, in this specification, the proximal end 10B of the stent 10 is defined as "the most proximal end of the stent 10, in which the link portion 12 arranged at the most proximal end is not provided."

[0048] The fixing portion 30 is a portion where the porous structure 20 is fixed to the stent 10. In this embodiment, the fixing portion 30 is composed of a weldable porous structure fixing material 50. By welding the porous structure fixing material 50 to the fixing portion 30, the porous structure 20 is embedded in the porous structure fixing material 50, and the porous structure 20 is fixed to the stent 10.

[0049] The material used for the porous structure fixing material 50 may be the polymer material listed as the material constituting the porous structure 20 described above. Wax may also be used as the porous structure fixing material 50. It is preferable to use a biodegradable polymer as the porous structure fixing material 50. With this configuration, the porous structure fixing material 50 is biodegradable, so that inflammation caused by the polymer is suppressed.

[0050] In this embodiment, the fixing portions 30 are provided at all locations of the link portion 12, as shown in FIGS.

[0051] In the indwelling device 100 according to this embodiment, as shown in Fig. 6 and Fig. 7A, the fixing portion 30 is provided on the link portion 12. Here, as shown in Fig. 10, the link portion 12 is a portion where the axial geometric change accompanying the expansion of the stent 10 is small. Therefore, tension is not generated in the porous structure 20 accompanying the expansion of the stent 10, and peeling or damage of the porous structure 20 can be suitably suppressed.

[0052] As described above, the link portion 12 is not provided with the drug coating layer 18. Therefore, the fixing portion 30 is configured by directly fixing the porous structure 20 to the stent 10 at the exposed portion 19 of the stent 10 where no drug is applied, as shown in Fig. 7A. In other words, the porous structure fixing material 50 constituting the fixing portion 30 is directly fixed to the link portion 12 of the stent 10, as shown in Fig. 7A. With this configuration, the adhesive strength of the porous structure 20 to the stent 10 when the porous structure fixing material 50 is welded can be improved compared to a configuration in which the porous structure fixing material 50 constituting the fixing portion 30 is fixed to the stent 10 via the drug coating layer 18.

[0053] In addition, for example, in a configuration in which the porous structure fixing material 50 is fixed to the stent 10 via the drug coating layer 18, the drug coating layer 18 is disposed in the vicinity of the porous structure fixing material 50, which has the effect of making it easier to suppress inflammatory reactions resulting from the porous structure fixing material.

[0054] The fixing part 30 is configured by directly fixing the porous structure 20 to the stent 10 at the exposed part 19 of the stent 10 where no drug is applied. Therefore, even if the fixing part 30 is welded by heating, the efficacy of the drug is not lost because there is no drug coating layer 18. Note that the configuration in which the porous structure fixing material 50 is fixed to the stent 10 via the drug coating layer 18 can be adopted when the fixing part 30 is formed by a method that does not require heating, such as an adhesive, or that is less affected by heating.

[0055] 6, in the fixing portion 30, loop portions 21 of a mesh woven along the circumferential direction of the porous structure 20 (the vertical direction in FIG. 6) are fixed to the stent 10. The fixed portion includes at least the loop portions 21, and may also include intersections with adjacent meshes. With this configuration, since the loop portions 21 extending along the circumferential direction are fixed to the stent 10, a long distance of the porous structure 20 can be embedded in the porous structure fixing material 50, improving the fixing force.

[0056] 8 and 9, the two-end fixing parts 40 fix the porous structure 20 to the stent 10 at the tip 10A and base end 10B of the stent 10. In particular, the two-end fixing parts 40 are preferably provided at the curved part 18A at the tip 10A of the stent 10 and at the curved part (not shown) at the base end 10B of the stent 10, as shown in FIG.

[0057] The method of fixing the porous structure 20 to the stent 10 at both end fixing parts 40 is the same as the method of fixing the porous structure 20 to the stent 10 at the fixing parts 30 described above, and therefore will not be described.

[0058] Here, since the living body indwelling device 100 of this embodiment has fixing parts 40 at both ends, when the living body indwelling device 100 is delivered to the lesion, the porous structure 20 can be prevented from being turned off from the stent 10 even if the lesion is severely curved.

[0059] <Method of manufacturing the living body indwelling device 100> Next, a method for manufacturing the living body indwelling object 100 will be described with reference to Figs. 11 to 15. Fig. 11 is a diagram showing a flow chart of the method for manufacturing the living body indwelling object 100 according to this embodiment. Fig. 12 is a diagram for explaining the state in which the porous structure fixing material 50 is arranged on the stent 10 in the arrangement step S01 of the method for manufacturing the living body indwelling object 100 according to this embodiment, and is a diagram corresponding to Fig. 3. Fig. 13 is a cross-sectional view for explaining the state in which the porous structure 20 is arranged in the arrangement step S01 of the method for manufacturing the living body indwelling object 100 according to this embodiment, and is a cross-sectional view corresponding to Fig. 7A. Fig. 14 is a cross-sectional view for explaining the pressing step S02 of the method for manufacturing the living body indwelling object 100 according to this embodiment, and is a cross-sectional view corresponding to Fig. 7A. Fig. 15 is a cross-sectional view for explaining the fixing step S04 of the method for manufacturing the living body indwelling object 100 according to this embodiment, and is a cross-sectional view corresponding to Fig. 7A. Figs. 13 to 15 show the upper half in the circumferential direction.

[0060] The manufacturing method of the living body indwelling device 100 according to this embodiment generally includes a positioning step S01, a pressing step S02, a melting step S03, and a fixing step S04, as shown in Fig. 11. Each step will be described in detail below.

[0061] <Placement process S01> First, the placing step S01 will be described. In the placing step S01, a porous structure fixing material 50 is placed on a part of the stent 10 as shown in Fig. 12. The method for placing the porous structure fixing material 50 on the stent 10 is not particularly limited, but it can be placed by coating, for example.

[0062] More specifically, the porous structure fixing material 50 is disposed on the link portion 12, the tip 10A, and the base end 10B of the stent 10. Here, as shown in FIG. 10, the link portion 12 is a portion where the axial geometric change accompanying the expansion of the stent 10 is small. Therefore, the porous structure 20 is not pulled as the stent 10 expands, and peeling or damage of the porous structure 20 can be suitably suppressed. In addition, since the porous structure fixing material 50 is disposed on the link portion 12, the tip 10A, and the base end 10B of the stent 10, when the porous structure 20 is fixed to the stent 10 in the fixing step S04 described later, the porous structure 20 is prevented from being deformed so as to spread outward in the radial direction and becoming bulky. Therefore, the porous structure 20 is prevented from being deformed so as to spread outward in the radial direction, and the deliverability of the in-vivo indwelling device 100 is prevented from being reduced. Furthermore, when the link portion 12 is not provided with the drug coating layer 18 as described above, the porous structure fixing material 50 is disposed on the exposed portion 19 of the stent 10. Therefore, as described above, the adhesive strength of the porous structure 20 to the stent 10 when the porous structure fixing material 50 is welded can be improved compared to a configuration in which the porous structure fixing material 50 is fixed to the stent 10 via the drug coating layer 18.

[0063] After the porous structure fixing material 50 is placed on the stent 10, the porous structure fixing material 50 has a gently sloping shape in cross section as shown in Fig. 13. Therefore, when the stent 10 on which the porous structure fixing material 50 is placed is deformed, it is possible to prevent the porous structure fixing material 50 from peeling off due to distortion or stress concentration in the porous structure fixing material 50. Furthermore, it is possible to prevent the porous structure fixing material 50 from getting caught on the inner wall or branching part of a blood vessel, or the end of a catheter, etc., when the indwelling device 100 is delivered to a lesion.

[0064] After the porous structure-fixing material 50 is placed on the stent 10, the porous structure 20 is placed on the outer surface of the porous structure-fixing material 50 as shown in FIG.

[0065] In the manufacturing method of the biological indwelling device 100 according to this embodiment, the porous structure fixing material 50 is placed on the stent 10, and then the porous structure 20 is placed on the outer surface of the porous structure fixing material 50, so that when the porous structure fixing material 50 is melted in the melting step S03, the porous structure 20 can be suitably fixed to the stent 10. Note that, in the method in which the porous structure 20 is first placed on the surface of the stent 10 and then the porous structure fixing material 50 is placed on its outer surface, when the porous structure fixing material 50 is, for example, a polymer solution or adhesive, the viscosity is adjusted so that the polymer solution or adhesive reaches the underside of the porous structure and does not spread laterally by wetting due to capillary action.

[0066] <Pressing process S02> Next, the pressing step S02 will be described. In the pressing step S02, first, as shown in Fig. 13, a pressing body 90 is prepared on the outer periphery of the porous structure 20, and a core metal 91 is prepared on the inner periphery of the stent 10. The core metal 91 functions as a receiving tool when the pressing body 90 presses the porous structure 20, the porous structure fixing material 50, and the stent 10. The pressing body 90 has laser light transparency. Examples of such materials that can be used include silicone rubber and fluororubber.

[0067] 14, the pressing body 90 presses the porous structure 20, the porous structure fixing material 50, and the stent 10 from the outer periphery to the inner periphery toward the core metal 91. As a result, tension is generated in the porous structure 20 toward the stent 10.

[0068] <Melting process S03> Next, the melting step S03 will be described. In the melting step S03, the porous structure fixing material 50 is irradiated with a laser beam to melt the porous structure fixing material 50. The laser beam is irradiated from the radial outside of the pressing body 90 toward the porous structure fixing material 50 through the pressing body 90. The wavelength of the irradiated laser beam is, for example, 800 to 10,000 nm. Here, since the pressing body 90 has laser beam transparency, the irradiated laser passes through the pressing body 90 and is irradiated to the porous structure fixing material 50. According to this method, the porous structure fixing material 50 can be melted in a short time (for example, within a few seconds), so that the time for the melting step S03 can be shortened.

[0069] Here, it is preferable that the material constituting the porous structure fixing material 50 has a lower melting point than the material constituting the porous structure 20. With this configuration, the porous structure 20 is suitably embedded in the porous structure fixing material 50 in the fixing step S04 described below.

[0070] <Fixed process S04> Next, the fixing step S04 will be described. The fixing step S04 is a step carried out successively to the melting step S03. That is, once the porous structure fixing material 50 is melted at one location in the melting step S03, the fixing step S04 is carried out at the same location continuously.

[0071] 15, in the fixing step S04, the porous structure 20, which has been subjected to tension toward the inner circumference in the pressing step S02, is embedded in the porous structure-fixing material 50 melted in the melting step S03. By embedding the porous structure 20 in the porous structure-fixing material 50 in this manner, the welding strength of the porous structure 20 to the stent 10 is improved. Through the above steps, the porous structure 20 is fixed to the stent 10 by the porous structure-fixing material 50.

[0072] 16 is a diagram showing a state in which the pressing body 90 and the core metal 91 have been removed. The porous structure fixing material 50 is formed as the fixing part 30 for fixing the porous structure 20 to the stent 10 by the above-mentioned process.

[0073] As described above, the manufacturing method of the indwelling device 100 according to this embodiment includes an arrangement step S01 of arranging the porous structure 20 having a large number of through-holes and the porous structure fixing material 50 on the stent 10 that extends in the axial direction and is formed to be expandable in the radial direction, and a fixing step S04 of melting the porous structure fixing material 50 to fix the porous structure 20 to the stent 10. According to this manufacturing method, after the porous structure fixing material 50 and the porous structure 20 are arranged on the stent 10 in the arrangement step S01, the porous structure fixing material 50 is melted in the fixing step S04 to fix the porous structure 20 to the stent 10, so that the porous structure 20 can be stably fixed to the stent 10.

[0074] Furthermore, in the positioning step S01, after the porous structure fixing material 50 is placed on the stent 10, the porous structure 20 is placed on the surface of the porous structure fixing material 50. According to this manufacturing method, the porous structure 20 can be suitably fixed to the stent 10 when the porous structure fixing material 50 is melted in the melting step S03.

[0075] In the arrangement step S01, the porous structure fixing material 50 is arranged so as to form a gently bulging shape in cross section. According to this manufacturing method, when the stent 10 on which the porous structure fixing material 50 is arranged is deformed, peeling of the porous structure fixing material 50 due to distortion or stress concentration in the porous structure fixing material 50 can be prevented.

[0076] In the fixing step S04, the porous structure 20 is embedded inside the porous structure fixing material 50. According to this manufacturing method, the welding strength of the porous structure 20 to the stent 10 is improved.

[0077] The porous structure fixing material 50 is made of a material selected from the group consisting of polymers and waxes. According to this manufacturing method, a suitable melting means can be selected depending on the material of the porous structure fixing material 50.

[0078] Furthermore, the material constituting the porous structure fixing material 50 has a lower melting point than the material constituting the porous structure. According to this manufacturing method, the porous structure 20 is suitably embedded in the porous structure fixing material 50 in the fixing step S04.

[0079] In the placement step S01, the porous structure fixing material 50 is placed on a part of the stent 10. This manufacturing method can prevent the porous structure 20 from deforming so as to spread outward in the radial direction and becoming bulky. Therefore, it is possible to prevent the porous structure 20 from deforming so as to spread outward in the radial direction and causing a decrease in the deliverability of the in-vivo indwelling device 100.

[0080] The stent 10 has linear rings 11 forming the outer periphery of a cylindrical shape with gaps formed therein, and a plurality of link parts 12 connecting the rings 11 with the gaps, and in the arrangement step S01, the porous structure fixing material 50 is arranged on at least one of the plurality of link parts 12. This manufacturing method can prevent the porous structure 20 from deforming so as to spread radially outward and becoming bulky. Therefore, it can prevent the porous structure 20 from deforming so as to spread radially outward and becoming less deliverable of the in-vivo indwelling device 100.

[0081] Furthermore, on the outer surface of the stent 10, a drug-coated layer 18 coated with a drug and an exposed portion 19 not coated with a drug are formed, and in the disposing step S01, a porous structure fixing material 50 is disposed on the exposed portion 19. According to this manufacturing method, it is possible to improve the adhesive strength of the porous structure 20 to the stent 10 when the porous structure fixing material 50 is welded.

[0082] In addition, the porous structure 20 is made of a stockinette stitch. This manufacturing method can prevent the axial shortening of the porous structure 20 caused by the expansion of the stent 10.

[0083] Also, in a manufacturing method for a biological indwelling device 100, a porous structure 20 having a knitted structure is fixed to a stent 10 that extends in an axial direction and is formed to be expandable and contractible in a radial direction, a porous structure fixing material 50 and the porous structure 20 arranged on the stent 10 are pressed toward the stent 10 by a pressing body 90, and the porous structure fixing material 50 is melted to fix the porous structure 20 to the stent 10. According to this manufacturing method, the porous structure 20 can be stably fixed to the stent 10.

[0084] In the step of melting the porous structure fixing material 50, the porous structure fixing material 50 is melted by a means selected from the group consisting of a laser, a light beam, heat, and ultrasonic waves. According to this manufacturing method, the porous structure fixing material 50 can be melted by a suitable means.

[0085] Moreover, the pressing body 90 has laser light transparency, and in the step of melting the porous structure fixing material 50, the porous structure fixing material 50 is irradiated with laser light via the pressing body 90. According to this manufacturing method, the porous structure fixing material 50 can be melted in a short time (for example, within a few seconds), so that the time for the melting step S03 can be shortened.

[0086] The manufacturing method of the living body indwelling device 100 according to the present invention has been described above through the embodiments, but the present invention is not limited to the methods described in the embodiments, and can be appropriately modified based on the description of the claims.

[0087] For example, in the above-described embodiment, the fixing parts 30 are provided at all positions of the link parts 12, but the fixing parts 30 may be provided at parts of all of the link parts 12. This configuration can reduce the amount of the porous structure fixing material 50 constituting the fixing parts 30 used, while preventing the porous structure 20 from deforming and becoming bulky so as to spread outward in the radial direction.

[0088] Furthermore, in the above-described embodiment, the fixing portion 30 is provided on the link portion 12. However, the fixing portion may be provided on the first strut portion 15 or the second strut portion 16. This configuration also makes it possible to prevent the porous structure 20 from deforming so as to expand radially outward, thereby preventing a decrease in the deliverability of the in-vivo implant.

[0089] In the above-described embodiment, the fixing portion 30 is provided on the link portion 12. However, the fixing portion may be provided on the link portion and the strut. With this configuration, the fixing portion is provided on the link portion and the strut, which further improves strength.

[0090] In the above-described embodiment, the fixing portion 30 is provided on the link portion 12. However, the fixing portion 430 of the indwelling device 400 according to the modified example may be provided on the third strut portion (first strut) 14 and / or the second strut portion (second strut) 16, which are adjacent to the link portion 12 on one side in the axial direction (for example, the left side in FIG. 17) and are provided as a pair in the circumferential direction (up and down in FIG. 17), as shown in FIG. 11. Note that FIG. 17 illustrates, as an example, a form in which the fixing portion 430 is provided on the third strut portion 14 and the second strut portion 16. According to this configuration, since the third strut portion 14 and the second strut portion 16 are provided near the link portion 12, the change in the axial geometry before and after expansion is small compared to the other struts, and peeling or damage of the porous structure 20 can be reduced. Furthermore, with this configuration, compared to a configuration in which a fixing portion is provided on the first strut portion 15 or the second strut portion 16, the possibility of a large gap occurring between the first strut portion 15 and the next first strut portion 15 spaced apart in the radial direction is reduced, thereby reducing peeling or damage to the porous structure 20. Furthermore, when the fixing portion 430 is provided on the third strut portion 14 or the second strut portion 16, peeling or damage to the porous structure 20 can be further reduced compared to when fixing portions 430 are provided on both the third strut portion 14 and the second strut portion 16.

[0091] In addition, in the above-described embodiment, a drug coating layer 18 coated with a drug was formed on the outer surface of the stent 10, but the drug coating layer 18 may not be formed on the outer surface of the stent 10, and the fixing portion 30 may be provided on a part of the link portion 12 or the strut.

[0092] In the above-mentioned embodiment, the indwelling device 100 is a balloon expansion type, but it may be a so-called self-expanding stent that is compressed in the central axis direction when inserted into the body and expands outward when placed in the body to restore the shape before compression. When the stent 10 is a self-expanding type, a superelastic alloy such as a nickel-titanium alloy is preferable because it needs a force to restore the original shape.

[0093] The shape of the stent is not particularly limited, and may be a stent having a shape as shown in Figures 18 and 19. For example, a stent 510 shown in Figure 18 has a ring 511 and a link portion 512. A stent 610 shown in Figure 19 has a ring 611 and a link portion 612.

[0094] In the above-described embodiment, the pressing body 90 presses the porous structure 20 against the stent 10 in the pressing step S02, thereby embedding the porous structure 20 in the porous structure fixing material 50 in the fixing step S04. However, the pressing body 90 may not be provided, and the porous structure may self-shrink to embed the porous structure in the porous structure fixing material 50 in the fixing step.

[0095] In the above-described embodiment, the porous structure fixing material 50 has a gentle protruding shape in cross section after the porous structure fixing material 50 is placed on the stent 10. However, the porous structure fixing material 50 does not have to have a gentle protruding shape after the porous structure fixing material 50 is placed on the stent 10.

[0096] In the above-described embodiment, in the fixing step S04, the porous structure 20 is embedded in the porous structure fixing material 50. However, in the fixing step S04, the porous structure 20 does not have to be completely embedded in the porous structure fixing material 50, and as long as the porous structure 20 is fixed to the stent 10, this is included in the present invention.

[0097] In addition, in the above-described embodiment, the porous structure fixing material 50 is arranged at the link portion 12, the tip 10A, and the base end 10B of the stent 10, but the porous structure fixing material 50 can be arranged at any position of the stent 10.

[0098] In addition, in the above-described embodiment, in the melting step S03, the porous structure fixing material 50 is melted by irradiating it with a laser, but the porous structure fixing material 50 may also be melted by irradiating it with a light beam or ultrasonic waves.

[0099] In the above-described embodiment, the porous structure fixing material 50 is melted by irradiating it with a laser in the melting step S03. However, the porous structure fixing material 50 pressed by the pressing body 90 and the stent 10 in which the porous structure 20 is disposed may be heated. The heating temperature at this time is equal to or higher than the melting point of the porous structure fixing material 50. This manufacturing method can shorten the processing time. [Explanation of symbols]

[0100] 10 stents, 11 rings, 12 Link section, 18 drug coating layer, 19 Exposed part, 20 porous structure, 50 Material for fixing porous structures, 100 Living body specimens, S01 Placement process, S04 Fixed process.

Claims

1. a placement step of placing a porous structure having a large number of voids passing therethrough and a porous structure fixing material on a stent formed to extend in an axial direction and be expandable in a radial direction; and a fixing step of melting the porous structure fixing material to fix the porous structure to the stent.

2. The method for producing a living body indwelling device according to claim 1 , wherein the porous structure includes a mesh having a knitted structure, and the porous structure fixing material includes a mesh fixing material.

3. 3. The method for producing a living body indwelling device according to claim 1, wherein in the positioning step, after the porous structure fixing material is placed on the stent, the porous structure is placed on a surface of the porous structure fixing material.

4. 3. The method for producing a living body indwelling device according to claim 1, wherein in the arranging step, the porous structure fixing material is arranged so as to form a gently sloping shape in a cross-sectional view.

5. 3. The method for producing a living body indwelling device according to claim 1, wherein in the fixing step, the porous structure is embedded inside the porous structure fixing material.

6. 3. The method for producing a living body indwelling device according to claim 1, wherein the porous structure fixing material is made of a material selected from the group consisting of polymers and waxes.

7. 3. The method for producing a living body indwelling device according to claim 1, wherein the material for forming said porous structure fixing material has a melting point lower than that of the material for forming said porous structure.

8. 3. The method for producing a living body indwelling device according to claim 1, wherein in the positioning step, the porous structure fixing material is positioned on a part of the stent.

9. The stent is A linear ring that forms the outer periphery of a cylindrical shape with a gap formed therein; a plurality of link portions connecting the rings to each other at the gaps; 3. The method for producing a living body indwelling device according to claim 1, wherein in the arranging step, the porous structure fixing material is arranged on at least one of the plurality of link parts.

10. The stent has an outer surface formed with a drug-coated layer and an exposed portion not coated with a drug, The method for producing a living body indwelling device according to claim 1 or 2, wherein in the placing step, the porous structure fixing material is placed on the exposed portion.

11. The method for producing a living body indwelling device according to claim 1 or 2, wherein the porous structure is constructed by knitting.

12. A method for manufacturing a living body indwelling device, comprising the steps of: fixing a porous structure having a large number of through-holes to a stent that is formed to extend in an axial direction and be expandable in a radial direction, the method comprising the steps of: A method for manufacturing a biological indwelling device, comprising pressing a porous structure fixing material placed on the stent and the porous structure toward the stent with a pressing body, melting the porous structure fixing material, and fixing the porous structure to the stent.

13. The method for producing a living body indwelling device according to claim 12, wherein the porous structure includes a mesh having a knitted structure, and the porous structure fixing material includes a mesh fixing material.

14. 13. The method for producing a living body indwelling device according to claim 12, wherein in the step of melting the porous structure fixing material, the porous structure fixing material is melted by a means selected from the group consisting of a laser, a light beam, heat, and ultrasonic waves.

15. The pressing body has laser light transmissibility, The method for producing a living body indwelling device according to claim 12, wherein in the step of melting the porous structure fixing material, the porous structure fixing material is irradiated with laser light via the pressing body.

16. 13. The method for producing a living body indwelling device according to claim 12, wherein in the step of melting the porous structure fixing material, the porous structure fixing material pressed by the pressing body and the stent in which the porous structure is disposed are heated.

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