Long medical device and its manufacturing method

Abstract

The elongated medical device has a base material portion (11) and an outer layer portion (12) made of resin based on a resin suspension coated on the outer peripheral surface of the base material portion. On the surface of the outer layer portion, there are irregularly arranged concave portions formed based on cracks generated by the drying of the resin suspension, and convex portions having an outer peripheral surface formed on the outer peripheral side of the concave portions.

Description

Technical Field

[0001] The present disclosure relates to long medical instruments. Background Art

[0002] The following technique is known: In order to achieve low frictional properties when inserting long medical instruments such as guidewires and catheters into the body, the surface of the long medical instrument is coated with a hydrophilic resin or a fluororesin, and irregularities are formed on the surface thereof (Patent Documents 1 and 2). According to this technique, the contact area between the long medical instrument and the tubular tissue in the body can be reduced. When inserting a long medical instrument into a blood vessel, in a healthy non-lesioned part, the blood vessel itself can maintain a tubular structure by blood pressure, and the viscosity of the blood is relatively low, so this technique is effective.

[0003] Prior Art Documents

[0004] Patent Documents

[0005] Patent Document 1: WO 2009 / 081844

[0006] Patent Document 2: Japanese Unexamined Patent Application Publication No. 2008-125523 Summary of the Invention

[0007] Problems to be Solved by the Invention

[0008] Research has been conducted on long medical instruments that can improve low frictional properties when passing through biological tubular tissues with high friction. There are cases where the friction is high when inserting a long medical instrument into the body. For example, in a blood vessel portion with a strong curvature such as the aortic arch or the internal carotid artery in the biological tubular tissues present in the body, a digestive tract with relatively high flexibility compared to the most normal blood vessels, a diseased blood vessel portion or a digestive tract where the liquid has a relatively high viscosity compared to blood, the friction when inserting a long medical instrument into the body becomes high.

[0009] Therefore, the present disclosure provides a long medical instrument capable of improving low frictional properties when passing through biological tubular tissues and a method for manufacturing the same.

[0010] Means for Solving the Problems

[0011] A long medical instrument according to one aspect of the present disclosure includes: a base material portion; and a resin outer layer portion based on a resin suspension coated on the outer peripheral surface of the base material portion. On the surface of the outer layer portion, there are irregularly arranged concave portions formed based on cracks generated by drying of the resin suspension, and convex portions having an outer peripheral surface formed on the outer peripheral side of the concave portions.

[0012] In the present disclosure, the "irregularly arranged recesses" refer to recesses that are not restricted by a predetermined pattern as a whole, rather than recesses formed based on a single or multiple combined predetermined patterns. That is, the recesses formed in the resin outer layer of the long medical device have a predetermined deviation that is greater than the deviation generated during manufacturing in terms of their depth, opening width, and the intervals between multiple recesses.

[0013] The long medical device according to another aspect of the present disclosure includes: a base portion; and a resin outer layer provided on the outer peripheral surface of the base portion. The outer layer has irregularly arranged recesses on its surface, and a convex portion forming an outer peripheral surface is formed on the outer peripheral side of the recesses. The outer layer is formed by drying after coating a resin suspension on the surface of the base portion, and the recesses are formed by drying the suspension coated on the outer layer.

[0014] Preferably, the recesses are irregularly arranged linearly in the circumferential direction and the major axis direction.

[0015] Preferably, the resin suspension for forming the outer layer contains fluororesin particles.

[0016] Preferably, the fluororesin particles are particles of perfluoroalkoxy alkane.

[0017] The long medical device is a guide wire, which includes: a base portion; a first region where a coil member is arranged on the outer periphery of the base portion; and a second region where a resin outer layer is arranged on the outer periphery of the base portion on the proximal side of the first region. Recesses can also be provided in the second region.

[0018] Preferably, the base portion has a tubular body and a reinforcing body formed on the outer peripheral side of the tubular body, and the outer layer covers the tubular body and the reinforcing body.

[0019] Preferably, an adhesive layer is provided on the outer peripheral side of the reinforcing body and between the outer layer, and the adhesive layer is formed of a resin with improved adhesiveness to the reinforcing body.

[0020] Preferably, the resin with improved adhesiveness is a fluororesin having an adhesive functional group.

[0021] Preferably, the fluororesin having an adhesive functional group is perfluoroalkoxy alkane having an adhesive functional group.

[0022] Preferably, the base portion has a tubular body, a reinforcing body formed on the outer peripheral side of the tubular body, and an intermediate resin layer formed to cover the tubular body and embed the reinforcing body, and the outer layer covers the tubular body and the reinforcing body.

[0023] Preferably, the intermediate resin layer and the outer layer are formed of different resins, and an adhesive layer is formed between the intermediate resin layer and the outer layer, and the adhesive layer is formed of a resin with improved adhesiveness to the intermediate resin layer.

[0024] Preferably, the resin forming the adhesive layer is a fluororesin having an adhesive functional group.

[0025] Preferably, the fluororesin having an adhesive functional group is a perfluoroalkoxyalkane having an adhesive functional group.

[0026] The manufacturing method of the long medical device according to another aspect of the present disclosure has the following steps: a first step of preparing a base material part; a second step of coating a resin suspension on the outer periphery of the base material part; a third step of drying the resin suspension coated on the base material part; and a fourth step of sintering the coating film of the resin suspension. In the third step, cracks are formed in the coating film of the dried resin suspension, and after the fourth step, recesses caused by the cracks are formed on the surface.

[0027] Preferably, the resin suspension contains fluororesin particles.

[0028] Preferably, the fluororesin particles are particles of perfluoroalkoxyalkane.

[0029] Preferably, between the first step and the second step, there is a fifth step of forming an adhesive layer using a resin having improved adhesiveness to the base material part.

[0030] Preferably, the resin having improved adhesiveness to the base material part is a fluororesin layer having an adhesive functional group.

[0031] Preferably, the fluororesin having an adhesive functional group is a perfluoroalkoxyalkane having an adhesive functional group.

[0032] Advantageous Effects of the Invention

[0033] According to the present disclosure, it is possible to reduce the contact area in contact with the tubular tissue in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 is a schematic diagram of a guide wire and a catheter using the guide wire according to an embodiment of the present disclosure.

[0035] Figure 2 is a longitudinal sectional view showing a part of the guide wire as an example of the long medical device.

[0036] Figure 3 is an explanatory diagram showing the step of forming a recess on the surface of the guide wire.

[0037] Figure 4 is an external view showing a state where cracks are formed on the surface of the guide wire.

[0038] Figure 5 is an enlarged external view showing a part of the guide wire.

[0039] Figure 6 is an enlarged external view showing a part of the guide wire of the comparative example.

[0040] Figure 7 It is a perspective view of a device for measuring the outer diameter of a guide wire.

[0041] Figure 8 It is a graph of data for measuring the outer diameter dimensions of a guide wire having a concave portion in the outer layer along the axial direction.

[0042] Figure 9 It is for Figure 8 A waveform diagram obtained by performing FFT analysis on the measurement data.

[0043] Figure 10 It represents Figure 8 A table showing the FFT analysis results of the measurement data.

[0044] Figure 11 It is a table showing the results of measuring the outer diameter dimensions of a guide wire having a concave portion in the outer layer.

[0045] Figure 12 It is a graph of data for measuring the outer diameter dimensions of a guide wire of a comparative example along the axial direction.

[0046] Figure 13 It is for Figure 12 A waveform diagram obtained by performing FFT analysis on the measurement data.

[0047] Figure 14 It represents Figure 12 A table showing the FFT analysis results of the measurement data.

[0048] Figure 15 It is a table showing the results of measuring the outer diameter dimensions of a guide wire of a comparative example.

[0049] Figure 16 It is a table showing the results of measuring the outer diameter dimensions of the tapered portion of the guide wire.

[0050] Figure 17 It is a table of analysis results for other cases where irregular concave portions are formed on the surface of the guide wire.

[0051] Figure 18 It is a graph of the measured outer dimensions.

[0052] Figure 19 It is a graph showing the FFT analysis results of the outer dimension measurement data.

[0053] Figure 20 It is a table of analysis results for other additional cases where irregular concave portions are formed on the surface of the guide wire.

[0054] Figure 21 It is a graph of the measured outer diameter dimensions.

[0055] Figure 22 It is a chart showing the FFT analysis result of the outer diameter dimension measurement data.

[0056] Figure 23 It is a chart comparing and showing the sliding resistance of a guide wire with a concave portion on its surface and a guide wire without a concave portion on its surface.

[0057] Figure 24 It is a longitudinal sectional view of the medical tube of Example 2.

[0058] Figure 25 It is an explanatory diagram showing the process of forming a concave portion on the surface of the medical tube.

[0059] Figure 26 It is a longitudinal sectional view of the medical tube of Example 3.

[0060] Figure 27 It is an explanatory diagram showing the process of forming a concave portion on the surface of the medical tube.

[0061] Figure 28 It is a table showing the FET analysis of the measurement data on the distal side of the guide wire of Example 4.

[0062] Figure 29 It is a table showing the FET analysis of the measurement data on the proximal side of the guide wire.

[0063] Figure 30 It is a table showing the measurement data of the guide wire.

[0064] Figure 31 It is a table showing the data of the measurement of the variation of the outer layer portion (recorded as outer layer resin) after removing the core wire from the guide wire.

[0065] Figure 32 It is a table showing the measurement data of other forms of guide wires.

[0066] Figure 33 It is a table showing the data of the measurement of the variation of the outer layer portion (recorded as outer layer resin) after removing the core wire from the guide wire.

[0067] Figure 34 It is a table showing the measurement data of another other form of guide wire.

[0068] Figure 35 It is a table showing the data of the measurement of the variation of the outer layer portion (recorded as outer layer resin) after removing the core wire from the guide wire.

[0069] Figure 36 It is related to Figure 30 The measurement data on the distal side of the corresponding guide wire and the enlarged external view.

[0070] Figure 37 are the measurement data and enlarged external view of the proximal side of the guide wire corresponding to Figure 30

[0071] Figure 38 are the measurement data and enlarged external view of the guide wire corresponding to Figure 32

[0072] Figure 39 are the measurement data and enlarged external view of the guide wire corresponding to Figure 34

[0073] Figure 40 is a table showing the values of MPF and MDF obtained by analyzing various guide wires.

[0074] Figure 41 is an explanatory diagram showing a chart made from the table of Figure 40

[0075] Figure 42 is a table analyzing the measurement data of the guide wire of Example 5.

[0076] Figure 43 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of a guide wire with a diameter of 0.79 mm.

[0077] Figure 44 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of another guide wire with a diameter of 0.79 mm.

[0078] Figure 45 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of a guide wire with a diameter of 0.70 mm.

[0079] Figure 46 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of a guide wire with a diameter of 0.55 mm.

[0080] Figure 47 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of a guide wire with a diameter of 0.415 mm.

[0081] Figure 48 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of another guide wire with a diameter of 0.415 mm.

[0082] Figure 49 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of yet another guide wire with a diameter of 0.415 mm.

[0083] Figure 50 is an explanatory diagram showing an enlarged external view and outer diameter data, etc. of another guide wire with a diameter of 0.415 mm.​​​​

[0084] Figure 51 It is an explanatory diagram showing an enlarged external view of another guide wire with a diameter of 0.415 mm and external diameter data, etc.

[0085] Figure 52 It is an explanatory diagram showing an example of a blood vessel using a guide wire.

[0086] Figure 53 It is an explanatory diagram showing a state in which a guide wire is used in a lower limb blood vessel model.

[0087] Figure 54 It is a graph showing the MPF when the resin coating speed is changed for a 0.415 mm guide wire.

[0088] Figure 55 It is a graph showing a comparison of the sliding resistance values when a 0.415 mm guide wire is used at a strongly bent part of a simulated blood vessel and when a 0.415 mm guide wire is used at a gently bent part of the simulated blood vessel, according to the resin coating speed.

[0089] Figure 56 It is a table showing the MPF of multiple guide wires made by changing the resin coating speed and the sliding resistance values when the above multiple guide wires are used at a strongly bent part of a simulated blood vessel.

[0090] Figure 57 It is a table showing the MPF of multiple guide wires made by changing the resin coating speed and the sliding resistance values when the above multiple guide wires are used at a gently bent part of a simulated blood vessel.

[0091] Figure 58 It is Figure 56 the measurement data of Figure 57 and the measurement data of

[0092] Figure 59 It is a graph showing a comparison and display of the sliding resistance values when PFA is coated on a guide wire and when PTFE is coated.

[0093] Figure 60 It is a table showing the depth dimension (depth of the fold) of the concave part, MPF, MDF, film thickness, and cumulative value of power values of the catheter of Example 6.

[0094] Figure 61 It is an enlarged view of the appearance of the proximal side (recorded as tube - upper) of the catheter.

[0095] Figure 62 It is a table showing the values of MDF and MPF.

[0096] Figure 63 A diagram showing the outer diameter of the catheter along the length direction of the catheter.

[0097] Figure 64 A diagram showing magnified Figure 63 a part of.

[0098] Figure 65 A table showing the result of analyzing the data of the proximal side of the catheter.

[0099] Figure 66 A table showing the measurement result of the outer diameter data of the proximal side of the catheter.

[0100] Figure 67 An enlarged view of the appearance near the center of the catheter (recorded as tube - middle).

[0101] Figure 68 A table showing the values of MDF and MPF.

[0102] Figure 69 A diagram showing the outer diameter of the catheter along the length direction of the catheter.

[0103] Figure 70 A diagram showing magnified Figure 69 a part of.

[0104] Figure 71 A table showing the result of analyzing the data near the center of the catheter.

[0105] Figure 72 A table showing the measurement result of the outer diameter data near the center of the catheter.

[0106] Figure 73 An enlarged view of the appearance of the distal side of the catheter (recorded as tube - lower).

[0107] Figure 74 A table showing the values of MDF and MPF.

[0108] Figure 75 A diagram showing the outer diameter of the catheter along the length direction of the catheter.

[0109] Figure 76 A diagram showing magnified Figure 75 a part of.

[0110] Figure 77 A table showing the result of analyzing the data of the distal side of the catheter.

[0111] Figure 78 A table showing the measurement result of the outer diameter data of the distal side of the catheter. Detailed implementation mode

[0112] In one aspect of the present disclosure, as described later, a plurality of recesses for reducing the contact area with the tubular tissue in the body are provided on the surface of the elongated medical instrument. These plurality of recesses are formed in a linear shape in the circumferential direction and the longitudinal axis direction. Thus, the elongated medical instrument of the present disclosure reduces the frictional resistance when passing through the biological tube tissue with a large friction. Since the elongated medical instrument of the present disclosure has a plurality of recesses on its surface, the contact area between the surface of the elongated medical instrument and the inner wall of the blood vessel can be reduced. Therefore, when the elongated medical instrument of the present disclosure is inserted into a blood vessel portion with a strong bend, for example, low friction can be achieved.

[0113] In the present embodiment, an outer layer portion is formed by coating a resin suspension on the outer peripheral surface of the base material portion. The outer layer portion has irregularly arranged recesses formed by drying the resin suspension, and a convex portion having an outer peripheral surface formed on the outer peripheral side of the recesses.

[0114] As one aspect, the elongated medical instrument has a base material portion and a resin outer layer portion provided on the outer peripheral surface of the base material portion. On the surface of the outer layer portion, there are irregularly arranged recesses and a convex portion having an outer peripheral surface formed on the outer peripheral side of the recesses. The outer layer portion is formed by drying after coating the surface of the base material portion with a resin suspension, and the recesses are formed by drying the suspension coated on the outer layer portion.

[0115] Preferably, the recesses are formed in a linear shape and are irregularly arranged in the circumferential direction and the longitudinal axis direction of the elongated medical instrument. Preferably, the resin suspension for forming the outer layer portion contains fluororesin particles.

[0116] The elongated medical instrument of the present disclosure can reduce the frictional resistance when inserted into a predetermined tubular tissue. The predetermined tubular tissue is, for example, a digestive tract with higher flexibility compared to a normal blood vessel, or a diseased blood vessel portion or digestive tract with a higher viscosity liquid compared to blood.

[0117] In other aspects of the present disclosure, an elongated medical instrument capable of improving the slidability is provided. In this aspect, by the recesses irregularly arranged on the surface of the outer layer portion, the sliding resistance between the elongated medical instrument and the biological wall such as the inner wall of the blood vessel in contact with the elongated medical instrument, or the sliding resistance between the elongated medical instrument and the inner wall of the lumen of other elongated medical instruments through which the elongated medical instrument is inserted can be reduced.

[0118] Hereinafter, embodiments of the present disclosure will be described. The elongated medical instrument of the present embodiment is configured as an elongated medical instrument such as guidewires 1, 1A or catheter 2. The elongated medical instrument has a base material portion 11, 11A, and resin outer layer portions 12, 12A provided on the surfaces of the base material portions 11, 11A. As will be described later, when the resin suspension is coated on the base material portions 11, 11A to form the outer layer portions 12, 12A, recesses 13 are irregularly formed in the circumferential direction and the longitudinal axis direction of the elongated medical instrument. The recesses 13 are irregularly formed based on cracks 130 generated when the resin suspension coated on the base material portions 11, 11A dries. In one aspect, irregularly arranged recesses and convex portions 14 forming an outer peripheral surface are provided on the surface of the outer layer portions 12, 12A on the outer peripheral side of the recesses.

[0119] In another aspect, the elongated medical instrument is a guidewire 1, and the guidewire 1 has: base material portions 11, 11A; a first region A1 in which a coil member 23 is arranged on the outer circumference of the base material portions 11, 11A; and a second region A2 in which resin outer layer portions 12, 12A are arranged on the outer circumference of the base material portions 11, 11A on the proximal side (the side of the person performing the operation or the proximal side) of the first region A1. The guidewire 1 has recesses in the second region A2.

[0120] The base material portion 11B has a tubular body 111B and a reinforcing body 113B formed on the outer peripheral side of the tubular body 111B, and the outer layer portion 12B may also cover the tubular body 111B and the reinforcing body 113B.

[0121] In still another aspect, the recesses 13 are irregularly arranged on a substantially flat surface 121 in the outer layer portions 12, 12A. The substantially flat surface 121 is a surface that is free of irregularities and flat except for the recesses 13 of the present disclosure. In other words, the substantially flat surface 121 is a surface without irregularities in the absence of the recesses 13 of the present disclosure. When the elongated medical instrument such as the guidewire 1 or the catheter 2 has irregular portions such as a coil shape, irregularities are presented on the surface corresponding to the irregular portions.

[0122] Therefore, the substantially flat surface 121 may also be a surface corresponding to a region where no coil is arranged below the outer layer portions 12, 12A. For example, when the elongated medical instrument 1 is a balloon catheter, an example is that the region on the proximal side of the balloon (the region where the balloon is not formed) is the substantially flat surface 121. When the elongated medical instrument 1 is a guidewire, an example is that the region on the proximal side of the region where the coil is formed at the tip of the guidewire (the region where the coil is not provided) is the substantially flat surface 121.

[0123] The case where the concave portion 13 of the present disclosure is irregularly formed on a surface other than the substantially flat surface 121 is also included within the scope of the present disclosure. For example, a long medical instrument is a type of the long medical instrument of the present disclosure, in which unevenness caused by a coil shape is formed on the surface of an outer layer portion 12 corresponding to the coil shape, and the concave portion 13 is formed.

[0124] The shape of the concave portion 13 may also be an indefinite-shaped linear portion. The shape of the concave portion 13 may also include a spatial frequency of 3 to 10 (1 / mm).

[0125] The irregularly arranged (formed) indefinite-shaped concave portions 13 can also be represented as indefinite-shaped linear portions 13 irregularly formed on the surfaces of the outer layer portions 12, 12A. Alternatively, the indefinite-shaped concave portions 13 can also be represented as indefinite-shaped linear portions 13 caused by cracks 130 generated in the outer layer portions 12, 12A.

[0126] Therefore, the long medical instrument of the present embodiment preferably exhibits, for example, having a base material portion 11, 11A, and resin outer layer portions 12, 12A provided on the surfaces of the base material portions 11, 11A, and a plurality of irregularly formed indefinite-shaped linear portions 13 and linear portions 12 recessed toward the base material portions 11, 11A are provided in a predetermined region 121 on the surface side of the outer layer portions 12, 12A.

[0127] The long medical instrument of the present embodiment preferably exhibits, for example, having a base material portion 11, 11A, and resin outer layer portions 12, 12A provided on the surfaces of the base material portions 11, 11A, and in a predetermined region 121 on the surface side of the outer layer portions 12, 12A, a plurality of irregularly formed indefinite-shaped linear portions 13 and linear portions 12 recessed toward the base material portions 11, 11A are provided due to cracks generated in the outer layer portions 12, 12A.

[0128] As the present embodiment, the concave portion formed in the direction in which the outer diameter becomes smaller compared with the substantially flat surface 121 of the outer layer portions 12, 12A is described, but it can also be fully understood that, for example, an indefinite-shaped convex portion 14 is formed in the direction in which the outer diameter becomes larger based on the diameter of the base material portion 11.

[0129] Hereinafter, as the long medical instrument, the guide wire 1 is described as an example. However, the present disclosure is not limited to the guide wire 1, and can also be applied to the catheter 2. Indefinite-shaped concave portions can also be irregularly formed on the outer layer portion provided on the surface of the catheter 2. The present disclosure can be applied not only to the guide wire or the catheter 2, but also to a long medical component (for example, an endoscope) for treatment inserted into a tubular biological tissue such as a blood vessel or a digestive tract.

[0130] Example 1

[0131] Use Figures 1 to 18 Example 1 will be described. As Figure 1 shown, the catheter 2 is used, for example, for diagnosing or treating a stenosis or an occlusion. The catheter 2 can also be a balloon catheter, a microcatheter, a cardiac catheter, a pulmonary artery catheter, an angiographic catheter, a urethral catheter, a digestive organ catheter, etc.

[0132] The catheter 2 includes a catheter shaft 21 and a joint tube 22 joined to the proximal end side of the catheter shaft 21. The catheter shaft 21 includes, for example, a coil body and a resin tube (both not shown) covering the outside of the coil body. On the inner peripheral side of the coil body, a lumen (not shown) through which the guide wire 1 or other catheter can be inserted is formed over the length direction of the coil body.

[0133] Figure 2 is a longitudinal sectional view showing the guide wire 1 of the present embodiment in an enlarged manner. The guide wire 1 has a core material 11 as an example of a "base material part" and an outer layer part 12 tightly provided so as to cover the surface of the core material 11. On the surface of the outer layer part 12, irregularly shaped concave parts 13 are formed. The guide wire 1 can also include a different resin layer (not shown) or the like between the core material 11 and the outer layer part 12. In addition, a coil-shaped part is sometimes provided on the front end side of the core material 11, but the illustration is omitted. Figure 2 is an enlarged view showing a region of the guide wire 1 where there is no coil-shaped part. The depth dimension h1 of the concave part 13 is not a constant value but is scattered. However, the depth dimension h1 of the concave part 13 does not exceed the thickness dimension of the outer layer part 12. The symbol 10 is the central axis of the guide wire 1.

[0134] As Figure 5 shown, the irregularly shaped concave part 13 is a wrinkled linear part formed with a plurality of parts on the surface of the guide wire 1 and is recessed toward the core material 11 side.

[0135] In Figure 2 the lower side of, a schematic cross section of the concave part 13 is shown. Figure 3 shows a method of forming the concave part 13. Refer to Figure 2 and Figure 3 for description.

[0136] In the coating step S1, the core material 11 is dip-coated with a PFA dispersion liquid which is a material for the outer layer part 12. The PFA dispersion liquid is a suspension in which particles (dispersed substances) of PFA are dispersed in a dispersion medium such as water. The entire circumference of the core material 11 can be dip-coated over the entire length or the entire circumference of a predetermined range in the core material 11 can be dip-coated. The dispersed substance is not limited to PFA. As long as it is a thermoplastic resin or a resin with low frictional resistance, it can be used as a material for the outer layer part 12.

[0137] In the temporary firing process S2, the dipped core material 11 is heated at the first temperature TEMP1 for the first time t1 to evaporate the dispersion medium and dry it. The temporary firing process can also be expressed as a drying process.

[0138] The first temperature TEMP1 can be selected, for example, from the range of a temperature equal to or higher than the evaporation temperature of the dispersion medium and lower than the melting point of the dispersoid (the evaporation temperature of the dispersion medium ≤ TEMP1 < the melting point of the dispersoid). The first time t1 can be set to the predetermined time required for the evaporation of the dispersion medium.

[0139] By coating the core material 11 with the suspension and heating it at the first temperature TEMP1, the dispersion medium evaporates from the surface of the suspension, and the dispersoid consolidates into a film shape. Inside it, the state of the suspension is maintained. On the inner peripheral side of the film-shaped dispersoid on the surface, the dispersion medium in the suspension evaporates sequentially from the vicinity of the surface, and the volume of the suspension decreases. As a result, a part of the film-shaped dispersoid on the surface sinks. During the period when the evaporation of the dispersion medium in the suspension continues, the sinking of the film-shaped dispersoid on the surface continues, and cracks 130 are generated. In the formal firing process S3, by heating at a temperature higher than the first temperature TEMP1, the dispersion medium evaporates rapidly. In the formal firing process S23, the suspension that becomes the outer layer portion 12 in the temporary firing process S2 is dried by sufficiently evaporating the dispersion medium in the suspension to the extent that no peeling of the dispersion medium occurs. For example, when a suspension containing ethylene glycol is used as the dispersion medium, the first temperature TEMP1 is heated at about 200 °C for about 2 minutes, thereby generating cracks 130.

[0140] Through the temporary firing process S2, as Figure 2 shown in the lower left of, cracks 130 are generated in the resin outer layer portion 12 provided on the surface of the guide wire 1. In Figure 2 the lower left of, one crack 130 is enlarged and schematically shown, but actually, as Figure 4 shown in the external view of, a plurality of cracks 130 are formed on the surface of the guide wire 1 after the temporary firing process S2 ends.

[0141] Return Figure 3 , in the formal firing process S3, the formal firing is performed by heating the guide wire 1 having cracks 130 on its surface at the second temperature TEMP2 for the second time t2. If the temporary firing process is called a drying process, the formal firing process can also be called a firing process. In addition, the temporary firing process and the formal firing process can also be carried out continuously in time.

[0142] The second temperature TEMP2 is set to be higher than the first temperature TEMP1 during temporary firing (TEMP1 < TEMP2). The second temperature TEMP2 is set to be higher than the melting point of the dispersoid (here, the melting point of PFA).

[0143] The second time t2 can be set to a time such that the resin on the upper side of the crack 130 melts and flows into the crack 130, and the crack 130 is not completely buried by the flowing resin. Next, the relationship between the first time t1 and the second time t2 will be described. The first time t1 as the time of the preliminary firing can be set to be equal to or greater than the second time t2 as the time of the final firing (t1≥t2). The first time t1 and the second time t2 can be set to the same value or approximate values.

[0144] As shown Figure 2 in the lower right of, the resin on the surface side of the outer layer portion 12 melts and flows into the crack 130, thereby forming the recess 13. The recess 13 is formed in a manner derived from the crack 130 and becomes an irregularly shaped linear shape similar to the crack 13. The cross-section of the recess 13 is gentler than the cross-section of the crack 130.

[0145] In this way, the recess 13 is formed in a manner derived from the crack 130 generated in the preliminary firing process S2 and becomes an irregularly shaped linear recess 13 formed on the surface of the outer layer portion 12. The recess 13 including any one or both of a curve and a straight line can also be referred to as a wrinkled shape.

[0146] As described above, Figure 4 A part of the surface of the wire guide 1 at the end of the preliminary firing process S2 is shown magnified. Figure 5 A part of the surface of the wire guide 1 at the end of the final firing process S3 is shown magnified. Magnification Figure 4 And Figure 5 at different places, the magnification is different, so the shape of the crack 130 does not correspond to the shape of the recess 13. However, in reality, as described above, the resin around flows into the crack 130 and forms the recess 13, so the shape of the crack 130 in plan view roughly corresponds to the shape of the recess 13 in plan view. However, there is a possibility that small cracks 130 are buried by the flowing resin.

[0147] Figure 6 A part of the wire guide 1CE as a comparative example is shown magnified. No irregular-shaped unevenness 13 is formed on the surface of the wire guide 1CE as a comparative example. If observed Figure 5 at a magnification higher than the magnification of the external view of Figure 6 shown, unevenness appears on its surface, but these unevenness are not intentionally formed.

[0148] Figure 7It represents a measuring device 3 for measuring the outer diameter dimension of the guide wire 1. The outer diameter measuring device 3 includes, for example, a frame 31, a flat plate portion 32 having an insertion hole 33, an outer diameter measuring instrument 34, a linear actuator 35, and a measurement control device 36. The outer diameter measuring instrument 34 and the measurement control device 36 can use, for example, the measuring head LS-9006 and the controller LS-9500 of the ultra-high speed-high precision dimension measuring instrument LS-9000 series of KEYENCE CORPORATION.

[0149] The frame 31 extends upward from a flat ground, and the flat plate portion 32 is installed midway in its vertical direction. An insertion hole 33 for inserting the guide wire 1 is formed in the flat plate portion 32. The outer diameter measuring instrument 34 is disposed around the insertion hole 33. The outer diameter measuring instrument 34 measures the outer diameter dimension of the object by laser, and the light projector and the light receiver are disposed opposite to each other across the insertion hole 33.

[0150] On the flat plate portion 32, at a position slightly away from the insertion hole 33, a linear actuator 35 is vertically provided. While holding one end of the guide wire 1 (the upper end of the guide wire 1 in Figure 7 ), the linear actuator 35 vertically moves upward at a constant speed according to a control signal from the measurement control device 36.

[0151] During the period when the guide wire 1 is pulled up vertically at a constant speed by the linear actuator 35, the outer diameter measuring instrument 34 measures the outer diameter dimension of the guide wire 1 in real time and outputs it to the measurement control device 36.

[0152] Using Figure 7 the measuring device 3, for example, the measurement can be performed with a sampling period of 8000 times / second for outer diameter measurement, a vertical movement speed of 10 mm / second, and a measurement length of 30 mm. The outer shape dimension data of the guide wire of this embodiment and the comparative example obtained by this measurement will be described below.

[0153] Figure 8 It is a graph showing the result (raw data) of measuring the outer diameter dimension of the guide wire 1 having irregularly formed irregular-shaped concavities and convexities 13 on the surface of the outer layer portion 12 using the outer diameter measuring device 3 described in Figure 7 . The vertical axis represents the outer diameter dimension (μm), and the horizontal axis represents the position in the length direction of the guide wire 1. From the Figure 8 graph, it can be seen that on the surface of the guide wire 1 of this embodiment, various concave portions 13 are irregularly formed in a recessed manner.

[0154] Figure 9 It is a waveform graph showing the result of performing FFT analysis on the measurement data shown in Figure 8 . The vertical axis represents the power value, and the horizontal axis represents the spatial frequency (1 / mm). According to Figure 9The waveform diagram shows that the waveform of the unevenness 13 includes the spatial frequency in the range from the lower limit value SF1 to the upper limit value SF2. The lower limit value SF1 is 1 (1 / mm), and the upper limit value SF2 is 10 (1 / mm). That is, according to experiments, if the concave portion 13 including the spatial frequency of 1 to 10 (1 / mm) is formed, the sliding resistance is reduced. And if the unevenness 13 with various shapes in plan view and cross-sectional shape is irregularly formed on the surface of the guide wire 1 in a manner including the spatial frequency of 3 to 10 (1 / mm), the effects described later in Figure 18 can be obtained.

[0155] Figure 10 Table T1 shows the results of FFT analysis of the outer diameter dimension of the guide wire 1 having the concave portion 13.

[0156] As recorded in the first row (1) of Table T1, in the guide wire 1 of this embodiment, the MPF is 5.7232 and the MDF is 5.542. As recorded in the second row (2) of Table T1, there are 289 data with a power value ratio greater than 0.01.

[0157] In the third row (3) to the seventh row (7) of Table T1, the data distribution status when changing the spatial frequency range relative to the MPF is shown. As shown in the third row (3), the cumulative value of the power values in all spatial frequency ranges is 7.834504. As shown in the fourth row (4), in the spatial frequency range of plus and minus 4 of the MPF, the cumulative value becomes 6.24272. The distribution ratio is 80%. As shown in the fifth row (5), in the spatial frequency range of plus and minus 3 of the MPF, the cumulative value becomes 5.40852. The distribution ratio is 69%. As shown in the sixth row (6), in the spatial frequency range of plus and minus 2 of the MPF, the cumulative value is 3.95915. The distribution ratio is 51%. As shown in the seventh row (7), in the spatial frequency range of plus and minus 1 of the MPF, the cumulative value is 2.10406. The distribution ratio is 27%, and the ratio difference between the distribution ratio of the plus and minus 4 spatial frequency and the distribution ratio of the plus and minus 1 spatial frequency is 53%.

[0158] As shown in the eighth row (8) of Table T1, in the spatial frequency range of 3 to 10 (1 / mm), the cumulative value is 5.546508. The distribution ratio is 71%.

[0159] Figure 11 Table shows the results of measuring the outer diameter dimension of the guide wire 1 having the concave portion 13 in the outer layer portion 12. The unit is μm. The maximum value of the outer diameter dimension is 573.1, the minimum value of the outer diameter dimension is 556, the median value of the outer diameter dimension is 564.55, the average value of the outer diameter dimension is 567.6373, and the variation value of the outer diameter dimension is 2.452621.

[0160] Regarding the variation in the outer diameter dimension, the maximum value of the outer diameter variation relative to the minimum value of the outer diameter dimension is 17, the minimum value of the outer diameter variation is 0, and the outer diameter variation rate is 3.0%. The outer diameter variation value is from 5.362737 to -11.6373 relative to the average value of the outer diameter dimension, and the outer diameter variation rate is from +0.94 to -2.05%. The outer diameter variation value is from 8.45 to -8.55 relative to the median value of the outer diameter dimension, and the outer diameter variation rate is from +1.50 to -1.51%.

[0161] Figure 12 It is a graph of the data obtained by measuring the outer diameter dimension of the guide wire 1CE of the comparative example along the axial direction. The vertical axis represents the outer diameter dimension (μm), and the horizontal axis represents the position in the length direction of the guide wire 1. From Figure 12 the graph, it can be seen that compared with the guide wire shown in Figure 8 , the surface of the guide wire 1CE of the comparative example has no unevenness and is smooth.

[0162] Figure 13 It is a waveform graph showing the result of FFT analysis of the measurement data shown in Figure 12 . The vertical axis represents the power value, and the horizontal axis represents the spatial frequency (1 / mm). According to Figure 13 the waveform graph, there is substantially no unevenness on the surface of the guide wire 1CE as the comparative example.

[0163] Figure 14 It is a table T2 showing the result of FFT analysis of the outer diameter dimension of the guide wire 1CE of the comparative example.

[0164] As recorded in the first row (1) of Table T1, in the guide wire 1CE of the comparative example, the MPF is 1.064 and the MDF is 0.2441. As recorded in the second row (2) of Table T2, there is no data with a power value greater than 0.01. In addition, the deviation generated between the value of MPF and the value of MDF is caused by a variation with a power value not shown in the figure at 1 (1 / mm) or more. This variation is caused by a diameter variation or the like generated by the processing of the core material 11 of the guide wire. Figure 13 This variation is caused by a diameter variation or the like generated by the processing of the core material 11 of the guide wire.

[0165] Rows 3 to 7 of Table T2 show the data distribution when changing the range of spatial frequency relative to MPF. As shown in row 3, the cumulative value in the entire spatial frequency range is 1.51776. As shown in row 4, in the range of spatial frequency of plus or minus 4 of MPF, the cumulative value becomes 0.926171. The distribution ratio is 61%. As shown in row 5, in the range of spatial frequency of plus or minus 3 of MPF, the cumulative value becomes 0.861739. The distribution ratio is 57%. As shown in row 6, in the range of spatial frequency of plus or minus 2 of MPF, the cumulative value is 0.801288. The distribution ratio is 53%. As shown in row 7, in the range of spatial frequency of plus or minus 1 of MPF, the cumulative value is 0.612517. The distribution ratio is 40%.

[0166] As shown in row 8 of Table T2, in the range of spatial frequency of 3 to 10 (1 / mm), the cumulative value is 0.357573. The distribution ratio is 24%.

[0167] Figure 15 It is a table showing the results of measuring the outer diameter size of the guide wire 1CE. The unit is μm. The maximum value of the outer diameter size is 561.7, the minimum value of the outer diameter size is 559, the median value of the outer diameter size is 560.35, the average value of the outer diameter size is 560.1724, and the variation value of the outer diameter size is 0.662483. Although the detailed description is omitted, the surface of the guide wire 1CE of the comparative example does not have the recess 13 of the present embodiment and is substantially smooth, so there is almost no variation in the outer diameter size.

[0168] Use Figure 16 , to illustrate the case where the guide wire 1 has a tapered portion. Figure 16 It is a table showing the results of measuring the outer diameter size of the tapered portion of the guide wire 1.

[0169] Although not shown in the figure, the guide wire 1 sometimes has a tapered portion that gradually tapers toward the front end side. In the tapered portion of the guide wire 1, a taper is formed on the core material 11, and a recess 13 is formed on the surface of the guide wire 1. Therefore, the change in the outer dimension of the tapered portion is larger than the change in the outer dimension of the non-tapered portion. Therefore, in order to find the change in the outer dimension caused by the formation of the recess 13 in the tapered portion, it is necessary to find the value of the corrected change in the outer dimension so as to offset the change in the diameter of the core material 11.

[0170] The correction of the change in the outer dimension is performed as follows: By approximating the change in the outer diameter of the core material 11 between the front end and the base end of the tapered portion with a linear function and using the inverse function of the linear function, etc., the outer diameter value is added or subtracted according to the distance from the front end or the base end of the tapered portion.

[0171] On the upper side of Figure 16 is shown the analysis value of the measurement data in the case where the concave portions 1 are irregularly formed on the tapered portion where the core material 11 of the guide wire 1 has a diameter reduction of 8 μm per 10 cm in the longitudinal direction. On the Figure 16 lower side is shown the analysis value of the measurement data in the case where the concave portions 13 are not formed on the tapered portion where the core material 11 of the guide wire 1CE has a diameter reduction of 8 μm per 10 cm in the longitudinal direction. The unit is μm.

[0172] Explanation is given for the upper side of the table. The maximum value of the outer diameter dimension is 570.205, the minimum value of the outer diameter dimension is 550.655, the median value of the outer diameter dimension is 560.43, the average value of the outer diameter dimension is 563.6368, and the variation value of the outer diameter dimension is 3.269153.

[0173] If focusing on the variation of the outer diameter dimension, the maximum value of the outer diameter variation relative to the minimum value of the outer diameter dimension is 19, the minimum value of the outer diameter variation is 0, and the outer diameter variation rate is 3.55%. The outer diameter variation value is from +6.363237 to -12.6368 relative to the average value of the outer diameter dimension, and the outer diameter variation rate is from +1.13% to -2.24%. The outer diameter variation value is from +9.57 to -9.43 relative to the median value of the outer diameter dimension, and the outer diameter variation rate is from +1.71% to -1.68%.

[0174] Therefore, compared with the case where there is no taper, the variation of the outer shape dimensions in the tapered portion becomes larger, so it is necessary to correct the outer shape dimensions in the tapered portion.

[0175] Explanation is given for Figures 17 to 22 . Figure 17 It is the analysis result table T3 for other cases where the irregular concave portions 13 are formed on the surface of the guide wire 1. Figure 18 It is the chart in which the outer shape dimensions are measured. Figure 19 It is the chart showing the FFT analysis result of the outer shape dimension measurement data. Figure 20 It is the analysis result table T4 for other cases where the irregular concave portions 13 are formed on the surface of the guide wire 1. Figure 21 It is the chart in which the outer shape dimensions are measured. Figure 22 It is the chart showing the FFT analysis result of the outer shape dimension measurement data. The analysis result table T3 and the analysis result table T4 are examples where the thickness of the resin-made outer layer portion 12 is formed thicker than that of Figures 8 to 10 the analysis result table T1.

[0176] As described in the first row (1) of Tables T1, T3, and T4, in the guide wire 1 having the concave portion 13, the MPF is in the range of 4 to 7, and the MDF is also in the range of 4 to 7. As described in the second row (2), there are at least 100 data points where the power value is greater than 0.01.

[0177] As described in the third row (3) to the seventh row (7) of Tables T1, T3, and T4, the lower limit of the distribution ratio of the spatial frequency of plus or minus 4 is 66%. The upper limit of the distribution ratio of the spatial frequency of plus or minus 1 is 35%. The lower limit of the distribution ratio of the spatial frequency of plus or minus 4 is set to the median value between the minimum value (70% of T4) of the fourth row (4) of Tables T1, T3, and T4 having irregularities and the value (61%) of the fourth row (4) of Table T2 without irregularities. The upper limit of the distribution ratio of the spatial frequency of plus or minus 1 is set to the median value between the maximum value (31% of T3) of the seventh row (7) of Tables T1, T3, and T4 having irregularities and the value (40%) of the seventh row (7) of Table T2 without irregularities. The lower limit of the ratio difference between the lower limit of the distribution ratio of the spatial frequency of plus or minus 4 and the upper limit of the distribution ratio of the spatial frequency of plus or minus 1 of the table having irregularities becomes 31%.

[0178] As shown in the eighth row (8) of Tables T1, T3, and T4, it can be seen that in the range where the spatial frequency is 3 to 10 (1 / mm), the irregular concave portion 13 of the present embodiment is formed on the surface of the catheter 1.

[0179] Figure 23 It is a chart showing a comparison of the sliding resistance of the guide wire 1 of the present embodiment having the concave portion 13 on the surface and the sliding resistance of the guide wire 1CE of the comparative example having no concave portion on the surface. The vertical axis represents the value of the sliding resistance. In Figure 23 a simulated environment is used where an endoscope is inserted from the oral cavity through the esophagus and stomach into the duodenum, and the guide wire is inserted through the endoscope. In this simulated environment, the guide wires 1 and 1CE are compared by simulating the situation of initially inserting the endoscope into the body and introducing the guide wire into an environment where the guide wire insertion lumen of the endoscope is filled with physiological saline, and the situation of introducing the guide wire into an environment where bile flows backward from the front end of the endoscope and the guide wire insertion lumen is filled with bile after the guide wire is inserted into the endoscope. The shaded column chart represents the guide wire 1 of the present embodiment, and the blank column chart represents the guide wire 1CE of the comparative example. It can be seen in any simulated experiment that the sliding resistance of the guide wire 1 of the present embodiment having the irregular concave portion 13 on the surface is small.

[0180] According to the present embodiment configured as described above, by irregularly arranging the concave portion 13 on the substantially flat surface 121 in the outer layer portion 13, the sliding resistance can be reduced. In particular, since the shape of the concave portion includes a shape presented over the range of the spatial frequency of 3 to 10 (1 / mm), the sliding resistance can be reduced.

[0181] As can be seen from the first row (1) of Tables T1 and T3, the sliding resistance is reduced when the value of at least one of MDF or MPF is 4 to 7 (1 / mm). Similarly, as can be seen from the first row (1) of Tables T1 and T3, the sliding resistance is reduced when the value of at least one of MDF or MPF is 5 (1 / mm) or more.

[0182] As can be seen from the second row (2) of Tables T1 and T3, the sliding resistance is reduced when there are at least 10 or more spatial frequencies with a power value of 0.01 or more.

[0183] From Figure 9 the FFT waveform diagram, the sliding resistance is reduced when the spatial frequencies with a power value of 0.01 or more are scattered in the range of 1 to 10 (1 / mm).

[0184] As can be seen from the seventh row (7) of Tables T1 and T3, the sliding resistance is reduced when the distribution ratio in the range of plus or minus 1 (1 / mm) of the average frequency component value is less than 35%.

[0185] As can be seen from the fourth row (4) of Tables T1 and T3, the sliding resistance is reduced when the distribution ratio in the range of plus or minus 4 (1 / mm) of the average frequency component value is about 80% or more.

[0186] From the ratio difference in the seventh row (7) of Tables T1 and T3, the sliding resistance is reduced when the difference between the distribution ratio of plus or minus 1 (1 / mm) and the distribution ratio of plus or minus 4 (1 / mm) of the average frequency component value is about 50% or more.

[0187] As can be seen from the eighth row (8) of Table T1, the sliding resistance is reduced when the power spectrum of the spatial frequencies 3 to 10 (1 / mm) is 50% or more. Similarly, as can be seen from the eighth row (8) of Table T1, the sliding resistance is reduced when the power spectrum of the spatial frequencies 3 to 10 (1 / mm) is 70% or more.

[0188] From Figure 11 the outer diameter change rate, the sliding resistance is reduced when the outer diameter change rate relative to the minimum outer diameter value is 3% or more.

[0189] From Figure 8 、 Figure 18 、 Figure 22 the charts, the sliding resistance is reduced when there are 10 or more outer diameter changes with a width less than 1 mm and 5 μm or more in the range of 1 CE m in the major axis direction.

[0190] From in Figure 16From the measurement results in the case where the tapered portion shown on the upper side has the recess 13 formed therein, it can be seen that when the outer layer portion 12 includes the tapered portion, if the rate of change in the outer diameter other than the change in the outer diameter caused by the tapered portion is 3% or more with respect to the minimum outer diameter value, the sliding resistance is reduced.

[0191] Example 2

[0192] Hereinafter, other embodiments will be described. In the present disclosure, for example, the following viewpoints are considered.

[0193] Even in a blood vessel, sometimes a highly viscous atherosclerotic thrombus is generated in a diseased portion. If the atherosclerotic thrombus invades into the recess 13 on the surface of the long medical instrument, the surface of the recess of the long medical instrument comes into contact with the atherosclerotic thrombus, and thus friction is generated.

[0194] Compared with normal blood, the digestive tract, which is another tubular tissue in the body, is filled with a digestive fluid having a relatively high viscosity. If the digestive fluid invades into the recess 13 on the surface of the long medical instrument, the surface of the recess 13 of the long medical instrument comes into contact with the digestive fluid, thereby generating friction.

[0195] The digestive tract wall has high flexibility, and the inner diameter of the digestive tract decreases due to peristaltic movement. Therefore, even for a long medical instrument having the recess 13 and the convex portion 14 on the surface, friction is generated between the long medical instrument and the digestive tract wall. When the distance between the convex portions 14 (or the distance between the recesses 13) formed in the long medical instrument is long, if the long medical instrument is inserted into the digestive tract, the surface of the soft digestive tract invades into the recess 13 and comes into contact therewith, and thus friction is generated.

[0196] On the surface of the long medical instrument, a resin suspension containing a fluororesin can be used to form the recess 13. In this case, there is a possibility that the adhesiveness between the fluororesin and the constituent member formed on its inner peripheral side decreases. The constituent member formed on the inner peripheral side of the fluororesin is a metal structure or another type of resin such as urethane. That is, as described above, if a wrinkled outer layer portion 12 having linearly arranged recesses 13 irregularly arranged is formed on the surface of the base portion 11, there is a possibility that the adhesiveness between the base portion 11 and the outer layer portion 12 decreases.

[0197] In view of the above viewpoints, the following structure is adopted in the present disclosure. In addition, at least a part of the following structure is also described in Example 1 or is substantially described in Example 1.

[0198] As described above, the linear recess 13 is formed by cracks caused by drying of the resin suspension. That is, when the resin suspension applied to the surface of the long medical instrument dries, cracks are irregularly generated, and the recess 13 is formed by these cracks.

[0199] The linear concave portion 13 is formed over a range of more than 90 degrees in the circumferential direction of the long medical instrument and is irregularly arranged in the circumferential direction and the long axis direction. The concave portion 13 may also be formed over the entire circumference of the long medical instrument.

[0200] The concave portion 13 is formed in the resin outer layer portion 12 formed on the surface of the long medical instrument, and the depth of the concave portion 13 is formed to be plus or minus 7% to plus or minus 25% of the average thickness of the outer layer portion 12.

[0201] It is also possible to provide an adhesive layer between the outer layer portion 12 in which the concave portion 13 is formed and the base material portion 11. That is, on the inner circumferential side of the resin suspension in which the concave portion 13 is formed, a fluororesin having an adhesive functional group is formed as an adhesive layer between the metal structure or other types of resins, and the resin suspension is coated on the outer circumferential side of the adhesive layer. Alternatively, the outer layer portion 12 may be formed using a resin suspension of a fluororesin having an adhesive functional group, and the concave portion 13 is formed in the outer layer portion 12. By adopting this structure, the adhesiveness between the outer layer portion 12 and the base material portion 11 can be improved.

[0202] The present disclosure adopts the above structure, and thus has the following effects.

[0203] When the long medical instrument is inserted into a normal blood vessel, since the concave portion 13 is formed on the surface of the long medical instrument, the contact area between the surface of the long medical instrument and the inner wall of the blood vessel is reduced. Therefore, low friction can be achieved when inserting the long medical instrument into the blood vessel.

[0204] Since the normal blood with low viscosity that passes before reaching the diseased blood vessel portion remains in the linear concave portion 13, it is possible to suppress the atherosclerotic thrombus from entering the concave portion 13 in the diseased blood vessel portion, and the friction on the surface of the long-axis medical instrument can be reduced.

[0205] When the long medical instrument is inserted into a tubular tissue such as the digestive tract, a liquid component such as highly viscous digestive fluid enters the linear concave portion 13. In this case, at the deep part (bottom) of the concave portion 13, the liquid with low viscosity (moisture) in the liquid component preferentially oozes out. Therefore, it is possible to suppress the highly viscous liquid component from entering the deep part of the concave portion 13, and the friction between the surface of the long-axis medical instrument and the tubular tissue can be reduced.

[0206] The concave portion 13 is formed over the circumferential direction and the long axis direction of the long medical instrument. Therefore, even when a highly viscous liquid component enters the concave portion 13, at least a part of the liquid component can be moved along the circumferential direction and / or the long axis direction of the long medical instrument from the entry position. By moving at least a part of the highly viscous liquid component that has entered the concave portion 13 to a place different from the concave portion 13, the friction between the surface of the long-axis medical instrument and the tubular tissue can be reduced.

[0207] Since linear recesses 13 are irregularly arranged in the circumferential direction and / or the major axis direction on the surface of the long medical instrument, the possibility that the unevenness on the surface of a soft body tissue such as the digestive tract coincides with the recesses 13 and the protrusions 14 formed on the surface of the long medical instrument over a constant distance can be reduced. Therefore, the contact area between the surface of the body tissue and the surface of the long medical instrument can be decreased, and the friction on the surface of the long medical instrument can be reduced.

[0208] Since an adhesive layer made of a fluororesin having an adhesive functional group that binds to a metal structure or other types of resins is provided between the outer layer portion 12 and the base material portion 11, the fluororesin of the adhesive layer is dissolved and combined with the fluororesin of the outer layer portion 12. Thereby, the adhesiveness between the base material portion 11 made of a metal structure or other types of resins and the outer layer portion 12 formed with the recesses 13 can be improved.

[0209] This disclosure includes an explanation of a manufacturing method of a long medical instrument. In the prior art, as shown in Patent Documents 1 and 2, unevenness is formed on the surface of a long medical instrument through a specially prepared unevenness forming process by physical processing or chemical treatment. The specially prepared unevenness forming process is a process of pressing a pattern for forming unevenness during the period when the outer layer resin of the long medical instrument remains soft, or a process of grinding the surface of the outer layer resin after the outer layer resin hardens to form unevenness, or a process of locally dissolving the surface of the outer layer resin to form unevenness. In the prior art, since a dedicated process for making unevenness only on the surface of the long medical instrument is specially prepared, the manufacturing process of the long medical instrument becomes complicated.

[0210] In contrast, in the long medical instrument of this disclosure, during the process of drying the resin suspension coated on the base material portion, cracks are formed on the film of the dried resin suspension, and then the film of the resin suspension is sintered, thereby forming recesses caused by the cracks. That is, in the manufacturing method of the long medical instrument of this disclosure, during a series of processes for forming the outer layer portion 12, the recesses 13 are formed.

[0211] As long as cracks can be formed through the resin suspension and drying after coating, the resin type and the medium of the medium are arbitrary.

[0212] In order to reduce the friction when inserting the long medical instrument into the body, the resin type can also be a fluororesin or a hydrophilic resin. As the fluororesin, perfluoroalkoxy alkane can also be used.

[0213] From the viewpoints of availability, ease of drying, and safety, water, alcohol, or a mixed solution mainly composed of water or alcohol can be used as the medium.

[0214] In the case where the resin suspension contains a fluororesin, a bonding layer made of a fluororesin having an adhesive functional group may be formed before applying the resin suspension to the base portion of the long medical instrument.

[0215] According to the method for manufacturing a long medical instrument of the present disclosure, there is no need to specially prepare a dedicated process for forming irregularities only on the surface of the long medical instrument, so that the manufacturing process of the long medical instrument can be prevented from being complicated. According to the method for manufacturing a long medical instrument of the present disclosure, a bonding layer is formed between the outer layer portion 12 and the base portion 11, so that the adhesiveness between the base portion 11 and the outer layer portion 12 of the fluororesin formed from the resin suspension can be improved.

[0216] Use Figure 24 And Figure 25 Example 2 will be described. In Example 2 and Example 3 described later, a medical tube is taken as an example of the long medical instrument. The medical tube 1A can be used, for example, as a sheath for a digestive organ basket portion. The medical tube 1A can also be used in other catheters.

[0217] The medical tube 1A has a base portion 11A and an outer layer portion 12A. The base portion 11A includes a tubular body 111A and an intermediate resin layer 112A provided on the outer peripheral side of the tubular body 111A. A bonding layer 113A for improving the adhesiveness with the inner peripheral surface of the outer layer portion 12A is provided on the outer peripheral surface of the intermediate resin layer 112A. The bonding layer 113A can also be regarded as a part of the base portion 11A.

[0218] Recesses 13 and protrusions 14 are formed on the surface of the outer layer portion 12A. The recesses 13 and the protrusions 14 can also be regarded as an integral relationship between the front and the back. That is, in the case of imagining the flat surface of the outer layer portion 12A, it can be considered that the portion where there is no recess 13 becomes a protrusion 14. Hereinafter, the recess 13 will be mainly described. The recess 13 is formed as a short linear shape extending in the circumferential direction and the long axis direction of the medical tube 1A and is irregularly arranged. The actual appearance will be described later.

[0219] Figure 25 The manufacturing method of the medical tube 1A is shown. In the first step S11, a PFA tube 111A as a "tubular body" is provided on the outer peripheral surface of the core bar 100A by extrusion molding. Surface treatment is performed on the PFA tube 111A. The surface treatment of the PFA tube 111A is, for example, a treatment for improving the close contact between the PFA tube 111A and the intermediate resin layer 112A. In the second step S12, a PTFE-based intermediate resin layer 112A is formed by applying a PTFE solution to the outer peripheral surface of the PFA tube 111A or by extrusion molding a PTFE tube on the outer periphery of the PFA tube 111A. A bonding layer 113A can also be provided on the surface of the intermediate resin layer 112A.

[0220] The material of the intermediate resin layer 112A is not limited to polytetrafluoroethylene (PTFE). As the intermediate resin layer 112A, it may also be at least one selected from the group consisting of PTFE, tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), nylon, and urethane.

[0221] When nylon or urethane is used as the intermediate resin layer 112A, in order to improve the adhesiveness between nylon or urethane and PFA, a fluororesin having an adhesive functional group can be used as the adhesive layer. That is, a fluororesin having an adhesive functional group (also referred to as an adhesive fluororesin) can be used as the adhesive layer 113A between nylon or urethane and PFA.

[0222] In the third step S13, a PFA solution is applied to the outer peripheral surface of the intermediate resin layer 112A (the outer peripheral surface of the adhesive layer 113A when the adhesive layer 113A is provided on the outside of the intermediate resin layer 112A), and drying and firing are carried out in the same manner as described in Example 1.

[0223] In the fourth step S14, the core bone 100A is pulled out to form the medical tube 1A.

[0224] Example 3

[0225] Use Figure 26 and Figure 27 Example 3 will be described. The medical tube 1B has a base portion 11B and an outer layer portion 12B. The base portion 11B includes a tubular body 111B and an intermediate resin layer 112B provided on the outer peripheral side of the tubular body 111B. On the outer peripheral surface of the intermediate resin layer 112B, an adhesive layer 113B for improving the adhesiveness with the inner peripheral surface of the outer layer portion 12B is provided. The adhesive layer 113B can also be regarded as a part of the base portion 11B. The intermediate resin layer 112B may also include a reinforcing body 114B.

[0226] On the surface of the outer layer portion 12B, recesses 13 and protrusions 14 are formed. The recesses 13 are formed as short linear shapes extending in the circumferential direction and the long axis direction of the medical tube 1B and are irregularly arranged. The actual appearance will be described later.

[0227] Figure 27 The manufacturing method of the medical tube 1B is shown. In the first step S21, a PFA tube 111B as the "tubular body" is provided on the outer peripheral surface of the core bone 100B by extrusion molding. Surface treatment is performed on the PFA tube 111B.

[0228] In the second step S22, a reinforcing body 114B is provided on the outer peripheral side of the PFA tube 111B.

[0229] In the third process S23, an intermediate resin layer 112B made of PTFE is formed by applying a PTFE solution in such a manner that the reinforcing body 114B is embedded.

[0230] In the fourth process S24, an adhesive layer 113B is provided on the surface of the intermediate resin layer 112B.

[0231] In the fifth process S25, a PFA solution is applied to the outer peripheral surface of the adhesive layer 113B, and drying and firing are carried out in the same manner as described in Example 1, thereby forming an outer layer portion 12B in which recesses 13 and 14 are formed.

[0232] In the sixth process S26, the core bone 100B is pulled out to form a medical tube 1B.

[0233] Example 4

[0234] Use Figures 28 to 41 Example 4 will be described. In Example 4 and Example 5 described later, a guide wire is taken as an example of a long medical instrument for description.

[0235] Figure 28 Table T11 is a table obtained by performing FET analysis on the measurement data of the distal side of the guide wire in Example 4.

[0236] As described in the first row (1) of Table T11, in the distal side of the guide wire, MPF is 3.6613 and MDF is 3.0762. As described in the second row (2) of Table T11, there are 38 data with a power value ratio greater than 0.01.

[0237] Rows (3) to (7) of Table T11 show the data distribution status when the range of the spatial frequency relative to MPF is changed. As shown in the third row (3), the cumulative value of the power values in all spatial frequency ranges is 1.784349. As shown in the fourth row (4), in the spatial frequency range of plus and minus 4 of MPF, the cumulative value becomes 1.462841. The distribution ratio is 82%. As shown in the fifth row (5), in the spatial frequency range of plus and minus 3 of MPF, the cumulative value becomes 0.928622. The distribution ratio is 52%. As shown in the sixth row (6), in the spatial frequency range of plus and minus 2 of MPF, the cumulative value is 0.695964. The distribution ratio is 39%. As shown in the seventh row (7), in the spatial frequency range of plus and minus 1 of MPF, the cumulative value is 0.418422. The distribution ratio is 23%, and the ratio difference between the distribution ratio of the spatial frequency of plus and minus 4 and the distribution ratio of the spatial frequency of plus and minus 1 is 59%.

[0238] As shown in the eighth row (8) of Table T11, in the range of spatial frequency from 3 to 10 (1 / mm), the cumulative value is 0.888071. The distribution ratio is 50%.

[0239] Figure 29 This is Table T12 which is the FET analysis of the measurement data of the proximal side of the guide wire in Example 4.

[0240] As recorded in the first row (1) of Table T12, on the proximal side of the guide wire, the MPF is 1.7521 and the MDF is 0.7568. As recorded in the second row (2) of Table T12, there are 64 data points where the power value ratio is greater than 0.01.

[0241] Rows 3 to 7 of Table T12 show the data distribution of the range of spatial frequency relative to the MPF. As shown in the third row (3), the cumulative value of the power values in the entire spatial frequency range is 2.819703. As shown in the fourth row (4), in the range of spatial frequency of plus or minus 4 of the MPF, the cumulative value becomes 2.701526. The distribution ratio is 96%. As shown in the fifth row (5), in the range of spatial frequency of plus or minus 3 of the MPF, the cumulative value becomes 2.616764. The distribution ratio is 93%. As shown in the sixth row (6), in the range of spatial frequency of plus or minus 2 of the MPF, the cumulative value is 2.361196. The distribution ratio is 84%. As shown in the seventh row (7), in the range of spatial frequency of plus or minus 1 of the MPF, the cumulative value is 0.683675. The distribution ratio is 24%, and the ratio difference between the distribution ratio of the spatial frequency of plus or minus 4 and the distribution ratio of the spatial frequency of plus or minus 1 is 72%.

[0242] As shown in the eighth row (8) of Table T21, in the range of spatial frequency from 3 to 10 (1 / mm), the cumulative value is 0.64181. The distribution ratio is 23%.

[0243] Figure 30 This is Table T13 showing the measurement data of the guide wire. The diameter of the distal side of this guide wire is 0.70 mm, and the diameter of the proximal side is 0.79 mm.

[0244] The upper side of Table T13 shows the measurement data of the distal side, and the lower side of Table T13 shows the measurement data of the proximal side. The measurement data includes the maximum outer diameter, the minimum outer diameter, the median outer diameter, the average outer diameter (all in μm), the maximum outer diameter variation, the minimum outer diameter variation, and the outer diameter variation rate.

[0245] Figure 31 This is Table T14 showing the data of the measurement of the variation of the outer layer 12 (recorded as outer resin) after removing the core wire from the guide wire.

[0246] The guide wire has a core wire as the base portion 11 and an outer resin as the outer layer portion 12 provided on the outside of the core wire. Irregularly arranged concave portions 13 are formed on the surface of the outer resin. The core wire itself does not affect the formation of the concave portions 13. Therefore, in the present embodiment, the depth of the concave portions 13 relative to the thickness of the outer resin layer capable of forming the concave portions 13 is shown.

[0247] The upper side of the table T14 shows the measurement data of the distal outer resin, and the lower side of the table T14 shows the measurement data of the proximal outer resin. The measurement data includes the maximum value of the outer resin thickness, the minimum value of the outer resin thickness, the median value of the outer resin thickness, the average value of the outer resin thickness (the unit is μm in all cases), the maximum value of the variation of the outer resin thickness, the minimum value of the variation of the outer resin thickness, and the variation rate of the outer resin thickness. In the figure, the outer resin thickness is recorded as the resin thickness.

[0248] It can be seen from the table T14 that the depth of the maximum concave portion relative to the overall thickness of the outer resin (for the minimum value) has a range of 17% to 85%. In the case where a concave portion with a depth of 100% of the outer resin thickness is formed, peeling of the outer resin will occur starting from this concave portion. Therefore, the concave portions 13 that do not reach 100% of the outer resin thickness are formed.

[0249] Figure 32 Table T15 shows the measurement data of a guide wire representing other forms. The diameter of this guide wire is 0.53 mm. The measurement data recorded in the table T15 includes the maximum outer diameter, the minimum outer diameter, the median outer diameter, the average outer diameter (the unit is μm in all cases), the maximum value of the outer diameter variation, the minimum value of the outer diameter variation, and the outer diameter variation rate.

[0250] Figure 33 Table T16 shows the data of the variation measured only for the outer layer portion (recorded as the outer resin) of the guide wire described in T15. The measurement data of the outer resin thickness includes the maximum value of the outer resin thickness, the minimum value of the outer resin thickness, the median value of the outer resin thickness, the average value of the outer resin thickness (the unit is μm in all cases), the maximum value of the variation of the outer resin thickness, the minimum value of the variation of the outer resin thickness, and the variation rate of the outer resin thickness.

[0251] Figure 34 Table T17 shows the measurement data of a guide wire representing still other forms. The diameter of this guide wire is 0.53 mm, and the diameters of the distal side, the central portion, and the proximal side are all the same. The measurement data recorded in the table T17 includes the maximum outer diameter, the minimum outer diameter, the median outer diameter, the average outer diameter (the unit is μm in all cases), the maximum value of the outer diameter variation, the minimum value of the outer diameter variation, and the outer diameter variation rate.

[0252] Figure 35Table T18 shows data obtained by measuring only the outer layer (described as the outer resin) of the guide wire described in T17. The measurement data for the outer resin thickness includes the maximum value of the outer resin thickness, the minimum value of the outer resin thickness, the median value of the outer resin thickness, the average value of the outer resin thickness (all in μm), the maximum value of the variation in the outer resin thickness, the minimum value of the variation in the outer resin thickness, and the variation rate of the outer resin thickness.

[0253] Figure 36 is the measurement data and magnified external view of the distal side of the guide wire corresponding to Figure 30 Figure 36 In [figure], the original data of the outer diameter dimension (the unit of the horizontal axis is mm, and the unit of the vertical axis is μm), the waveform data obtained by FET analysis of the original data of the outer diameter dimension (the unit of the horizontal axis is Hz, and the unit of the vertical axis is amplitude), the waveform data obtained by magnifying the amplitude of the waveform data of the FET analysis, and the external view are shown in order from the top.

[0254] As shown in the external view, on the surface of the guide wire, a plurality of recesses 13 are formed over a range of 90 degrees or more in the circumferential direction. Focusing on the shape, it can be seen that a plurality of recesses 13 with linear, S-shaped, inverted S-shaped, serpentine, or curved shapes are mixed.

[0255] Figure 37 is the measurement data and magnified external view of the proximal side of the guide wire corresponding to Figure 30 Most of the recesses 13 are independent of each other. However, recesses 13b connecting adjacent recesses can also be seen.

[0256] Figure 38 is the measurement data and magnified external view of the guide wire corresponding to Figure 32

[0257] Figure 39 is the measurement data and magnified external view of the guide wire corresponding to Figure 34

[0258] Figure 40 represents Figures 36 to 39 Table T19 showing the MPF and MDF values obtained by analyzing a plurality of guide wires described in Figure 40 ​​​In this case, the "existing product" and the "front-end coater" are components formed by coating a whole or a part of a core wire cut to a predetermined length and used as a guide wire with a resin suspension by means such as dipping, followed by drying and sintering. In the "existing product" and the "front-end coater", an outer layer and a recess 13 can be formed in a part of the core wire. For example, after attaching an outer layer coil to the front end of the guide wire, an outer layer and a recess 13 can be formed only on the base end side of the guide wire except for the area where the outer layer coil is attached. The "continuous coater" is a component formed by coating a resin suspension on a core wire wound into a reel shape, drying and sintering it, and then winding it into a reel shape again. In the "continuous coater", an outer layer and a recess 13 are formed on the whole of the core wire having a constant diameter, and in the manufacture of the guide wire, it is cut to a predetermined length, and a diameter reduction process such as grinding is performed on the front end portion. Therefore, the outer layer is removed in the range where the diameter reduction process is performed.

[0259] In the manufacture of the guide wire, no matter which manufacturing method is adopted, it means that an outer layer and a recess 13 are formed on the base end side of the area where the outer layer coil is attached.

[0260] Figure 41 is a diagram showing Figure 40 the explanatory diagram of Table T19.

[0261] Example 5

[0262] Use Figures 42 to 59 to explain Example 5. In this example, the case of forming a recess on the surface of a guide wire thinner than the guide wires described so far is explained.

[0263] Figure 42 is Table T21 obtained by analyzing the measurement data of the guide wire in Example 5. In addition to the measurement data of the guide wires with diameters of 0.79 mm, 0.70 mm, and 0.55 mm, Table T21 also shows the measurement data of the guide wire with a diameter of 0.415 mm. And for the guide wire with a diameter of 0.415 mm, the cases of forming wrinkles (recess 13) and not forming wrinkles are also recorded in Table T21.

[0264] In Example 5, the speed V (referred to as the coating speed or the outer layer resin forming speed) at which the resin to be the outer layer portion 12 is coated on the surface of the guide wire is changed, and the generation state of the recess 13 is measured.

[0265] The measurement data in Table T21 includes the depth of the recess 13 (recorded as "depth of the wrinkle"), MPF, MDF, film thickness, and the cumulative value of the power value. Here, the depth of the wrinkle is defined as half of the difference between the unevenness of the outer diameter data.

[0266] When comparing the depth of the wrinkles of a guide wire with a diameter of 0.55 mm, as well as the MPF and MDF, with the depth of the wrinkles of a guide wire with a diameter of 0.415 mm that forms wrinkles, as well as the MPF and MDF, there is no significant change in the MPF and MDF of the guide wire with a diameter of 0.55 mm compared to the MPF and MDF of the guide wire with a diameter of 0.415 mm. Therefore, it can be considered that the depth of the wrinkles has no effect on the MPF and MDF.

[0267] When comparing the cumulative values of the power values of the guide wires of each diameter, the cumulative value of the power value of the non-wrinkled guide wire is lower than the cumulative value of the power values of the other guide wires. Therefore, it can be considered that the depth of the wrinkles can be inferred to some extent from the cumulative value of the power values.

[0268] Figure 43 It is an explanatory diagram showing the enlarged external view and outer diameter data of a guide wire with a diameter of 0.79 mm. Figure 43 Among them, the external view of the guide wire, the chart of the outer diameter data of the guide wire, the chart of the outer diameter data enlarged in the X-axis direction, the frequency distribution, and the table containing the values of MPF and MDF are shown in order from above. The table containing the values of MPF and MDF has a structure roughly the same as the tables T11 and T12 described in Figure 28 , Figure 29 The table is shown enlarged on the lower side of Figure 43 .

[0269] The vertical axis of the chart of the outer diameter data is in μm, and its maximum scale is "860". The unit of the horizontal axis of the chart of the outer diameter data is mm, and its maximum scale is "30". The maximum scale of the horizontal axis of the chart enlarged in the X-axis direction is "5.0". The MPF of this guide wire is 5.10 and the MDF is 4.81.

[0270] Figure 44 It represents the enlarged external view and outer diameter data of another guide wire with a diameter of 0.79 mm. The MPF of this guide wire is 6.13 and the MDF is 6.03.

[0271] Figure 45 It is the enlarged external view and data of a guide wire with a diameter of 0.70 mm. The MPF of this guide wire is 6.90 and the MDF is 6.91.

[0272] Figure 46 It is the enlarged external view and data of a guide wire with a diameter of 0.55 mm. The MPF of this guide wire is 4.72 and the MDF is 4.52.

[0273] Figure 47 It is the enlarged external view and data of the case where a resin is coated on a guide wire with a diameter of 0.415 mm at a coating speed of V1. The MPF of this guide wire is 4.37 and the MDF is 4.08.

[0274] Figure 48 An enlarged external view and data of the case where a resin was coated on a guide wire with a diameter of 0.415 mm at a coating speed V3. The MPF of this guide wire is 3.53 and the MDF is 0.51.

[0275] Figure 49 An enlarged external view and data of the case where a resin was coated on a guide wire with a diameter of 0.415 mm at a coating speed V4. The MPF of this guide wire is 3.80 and the MDF is 0.49.

[0276] Figure 50 An enlarged external view and data of the case where a resin was coated on a guide wire with a diameter of 0.415 mm at a coating speed V5. The MPF of this guide wire is 2.58 and the MDF is 0.44.

[0277] Figure 51 An enlarged external view and data of the case where a resin was coated on a guide wire with a diameter of 0.415 mm at a coating speed V2. The MPF of this guide wire is 1.88 and the MDF is 0.12.

[0278] An explanation of the resin coating speed. The resin coating speed is the speed when forming a resin coating film that becomes the outer layer portion 12 on the surface of the guide wire (or catheter). In this embodiment, the coating speed V1 is the fastest and the coating speed V2 is the slowest. The coating speeds V3, V4, and V5 are between the coating speeds V1 and V2, and have the relationship of V1 > V3 > V4 > V5 > V2. From the experimental results of Example 5, it can be seen that if the coating speed is V2 or less, the concave portion 13 will not be formed on the surface of the outer layer portion 12. It can be seen that if the coating speed exceeds V2 and becomes faster, it is easier to form the concave portion 13. Therefore, in Example 5, for example, it is disclosed that "by coating a resin suspension on the surface of the base material portion 11 at a predetermined speed or more, the concave portions 13 formed based on the cracks generated by the drying of the resin suspension and arranged irregularly" are provided.

[0279] Figure 52 An explanatory diagram showing an example of a blood vessel using a guide wire. The simulated blood vessel model M1 is formed, for example, by simulating the case where a flexion lesion has occurred in the common iliac artery. Here, the flexion Ra is called a gentle bending portion. The simulated blood vessel that can achieve the gentle bending portion can be called a gentle bending simulation Ra.

[0280] Figure 53 A lower limb blood vessel model M2 formed with a strong bending portion Rb is shown. The radius of curvature of the strong bending portion Rb is smaller than the radius of curvature of the gentle bending portion Ra (Rb < Ra).

[0281] Figure 54 A graph showing the difference in MPF when changing the resin coating speed for a 0.415 mm guide wire.

[0282] Figure 55 It is a graph showing a comparison of the sliding resistance values when a guide wire of 0.415 mm is used at a site simulating a strongly curved blood vessel and when a guide wire of 0.415 mm is used at a site simulating a gently curved blood vessel, according to the coating speed of the resin.

[0283] From Figure 54 and Figure 55 it can be seen that there is a tendency for the value of MPF to increase and the sliding resistance value to decrease as the coating speed increases. Furthermore, it can be seen that there is a negative correlation between MPF and the sliding resistance value. MPF is the average frequency, and the detection frequency is the number of folds (concavities and convexities). Therefore, a larger value of MPF means more folds, and it is considered that more folds improve the slidability.

[0284] Figure 56 It is a table showing the MPF of a plurality of guide wires made by changing the coating speed of the resin and the sliding resistance values when the above-mentioned plurality of guide wires are used at the strongly curved portion Rb of the simulated blood vessel.

[0285] Figure 57 It is a table showing the MPF of a plurality of guide wires made by changing the coating speed of the resin and the sliding resistance values when the above-mentioned plurality of guide wires are used at the gently curved portion Ra of the simulated blood vessel.

[0286] Figure 58 It is according to the types of curvature Ra and Rb of the simulated blood vessel for Figure 56 the measurement data of Figure 57 and

[0287] From Figures 56 to 58 it can be seen that the sliding resistance value of the guide wire at the gently curved portion Ra is smaller than that of the guide wire at the strongly curved portion Rb.

[0288] Figure 59 It is a graph showing a comparison of the sliding resistance values when PFA is coated on the guide wire and when PTFE is coated.

[0289] In Figure 59 the sliding resistance values of the PFA-coated guide wire with folds (concave portions 13) on the surface and the PTFE-coated guide wire without folds on the surface are compared according to the strength of the curved portion.

[0290] As the average value of the film thickness of the PFA coating, guide wires of 13.3 μm and 14.8 μm are shown. As the average value of the film thickness of the PTFE coating, guide wires of 15.3 μm and 15.8 μm are shown.

[0291] From Figure 59It can be seen that by forming wrinkles (recesses 13) on the surface of the resin layer that becomes the outer layer portion 12, the sliding resistance value of the guide wire coated with PFA with wrinkles is smaller than that of the guide wire coated with PTFE without wrinkles. Moreover, in terms of the dynamic friction coefficient, which is a mechanical property of fluororesin, the guide wire coated with PFA without wrinkles is larger than the guide wire coated with PTFE without wrinkles.

[0292] In addition, in Figure 59 , wrinkles were formed on the surface of the PFA resin layer, and a comparison was made with the PTFE resin layer without wrinkles as a comparative example. However, the present disclosure does not exclude the formation of wrinkles and the reduction of sliding resistance in resin layers other than PFA. They are also included within the scope of the present disclosure.

[0293] Example 6

[0294] Use Figures 60 to 78 to illustrate Example 6. In Example 6, the results of the case where recesses 13 are irregularly formed on the surface of the catheter are illustrated.

[0295] Figure 60 is a table showing the depth dimension (depth of wrinkles), MPF, MDF, film thickness, and cumulative value of power values of the recesses of the catheter of Example 6.

[0296] In this table, the proximal side of a medical tube (catheter) with a diameter of 2 mm, the central portion of a medical tube (catheter) with a diameter of 2 mm, the distal side of a medical tube (catheter) with a diameter of 2 mm, a guide wire with a diameter of 0.79 mm, a guide wire with a diameter of 0.70 mm, a guide wire with a diameter of 0.55 mm, a guide wire with a diameter of 0.415 mm (with wrinkles on the surface), and a guide wire with a diameter of 0.415 mm (without wrinkles on the surface) are shown for the depth of wrinkles, MPF, MDF, film thickness, and cumulative value of power values. The data for the guide wire is the same as that Figure 42 shown.

[0297] Figure 61 is an enlarged view of the appearance of the proximal side of the catheter (recorded as tube - upper). It can be seen that the recesses 13 are formed in a mesh pattern. Figure 62 is a table showing the values of MDF and MPF. Figure 63 is a graph showing the outer diameter of the catheter along the length direction of the catheter. Figure 64 is an enlarged view showing Figure 63 a part of Figure 65 is a table showing the results of analyzing the data of the proximal side of the catheter. Figure 66 is a table showing the measurement results of the outer diameter data of the proximal side of the catheter.

[0298] Figure 67It is an enlarged view of the appearance near the center of the catheter (described as tube-center). Figure 68 It is a table showing the values of MDF and MPF. Figure 69 It is a graph showing the outer diameter of the catheter along the length direction of the catheter. Figure 70 It is an enlarged view showing Figure 69 a part of Figure 71 It is a table showing the result of analyzing the data near the center of the catheter. Figure 72 It is a table showing the measurement result of the outer diameter data near the center of the catheter.

[0299] Figure 73 It is an enlarged view of the appearance of the distal side of the catheter (described as tube-lower). Figure 74 It is a table showing the values of MDF and MPF. Figure 75 It is a graph showing the outer diameter of the catheter along the length direction of the catheter. Figure 76 It is an enlarged view showing Figure 75 a part of Figure 77 It is a table showing the result of analyzing the data of the distal side of the catheter. Figure 78 It is a table showing the measurement result of the outer diameter data of the distal side of the catheter.

[0300] Above, the embodiments of the present disclosure have been described, but the present disclosure is not limited to these embodiments and can be variously modified.

[0301] The above embodiments are described in detail for the purpose of easily clarifying the description of the present invention and are not necessarily limited to all the structures described. In addition, a part of the structure of one embodiment can be replaced with the structure of another embodiment. In addition, the structure of another embodiment can be added to the structure of one embodiment. In addition, other structures can be added to, deleted from, or replaced with a part of the structure of each embodiment.

[0302] In addition, the technical features included in the above embodiments are not limited to the combinations explicitly shown in the scope of the technical solution and can also be appropriately combined.

[0303] The present disclosure includes the structures shown by the following expressions.

[0304] (Expression 1)

[0305] A long medical device having:

[0306] a base material part; and

[0307] a resin outer layer part provided on the surface of the above base material part,

[0308] On the substantially flat surface in the above outer layer part, there are irregularly arranged concave portions or convex portions.

[0309] (Expression 2)

[0310] The long medical device according to Expression 1,

[0311] The substantially flat surface is a surface corresponding to a region where no coil is disposed below the outer layer portion.

[0312] (Expression 3)

[0313] The long medical device according to Expression 1,

[0314] The shape of the concave portion is an irregular linear portion.

[0315] (Expression 4)

[0316] The long medical device according to Expression 3,

[0317] The shape of the waveform representing the outer diameter having the concave portion or the convex portion includes a spatial frequency of 3 to 10 (1 / mm).

[0318] (Expression 5)

[0319] A long medical device having:

[0320] A base material portion; and

[0321] A resin outer layer portion provided on the surface of the base material portion,

[0322] On the substantially flat surface in the outer layer portion, there are irregularly arranged concave portions or convex portions,

[0323] When performing FET (Fast Fourier Transform) analysis on the measurement result of the outer diameter dimension of the outer layer portion in the longitudinal axis direction, at least any one of the following (Condition 1) to (Condition 9) is satisfied.

[0324] (Condition 1) At least one of the values of the central power frequency (MeDianPowerFrequency: MDF. Hereinafter referred to as MDF) or the average frequency (MeanPowerFrequency: MPF. Hereinafter referred to as MPF) is 4 to 7 (1 / mm),

[0325] (Condition 2) At least one of the values of MDF or MPF is 5 (1 / mm) or more,

[0326] (Condition 3) There are at least 100 or more spatial frequencies with a power value of 0.01 or more,

[0327] (Condition 4) The spatial frequencies with a power value of 0.01 or more are dispersed and present in the range of 1 to 10 (1 / mm),

[0328] (Condition 5) The distribution ratio within the range of plus or minus 1 (1 / mm) of the average frequency component value is less than 35%.

[0329] (Condition 6) The distribution ratio within the range of plus or minus 4 (1 / mm) of the average frequency component value is approximately 70% or more.

[0330] (Condition 7) The difference between the distribution ratio of plus or minus 1 (1 / mm) and the distribution ratio of plus or minus 4 (1 / mm) of the average frequency component value is approximately 40% or more.

[0331] (Condition 8) The power spectrum of the spatial frequency 3 to 10 (1 / mm) is 50% or more.

[0332] (Condition 9) The power spectrum of the spatial frequency 3 to 10 (1 / mm) is 65% or more.

[0333] (Expression 6)

[0334] A long medical device having:

[0335] A base material part; and

[0336] An outer layer part made of resin provided on the surface of the above-mentioned base material part,

[0337] On the substantially flat surface in the above-mentioned outer layer part, there are irregularly arranged concave parts or convex parts, and the measurement result of the outer diameter dimension in the long axis direction of the above-mentioned outer layer part satisfies at least one of the following (Condition 10) and (Condition 11).

[0338] (Condition 10) The outer diameter change rate with respect to the minimum outer diameter value is 3% or more.

[0339] (Condition 11) In the range of 1 CE m in the long axis direction, there are 10 or more parts where the outer diameter change with a width less than 1 mm and 5 μm or more exists.

[0340] (Expression 7)

[0341] The long medical device according to Expression 6,

[0342] In the above-mentioned Condition 10, when the above-mentioned outer layer part includes a tapered part, the outer diameter change rate excluding the outer diameter change caused by the above-mentioned tapered part is 3% or more with respect to the minimum outer diameter value.

[0343] (Expression 8)

[0344] The long medical device according to any one of Expressions 1 to 7,

[0345] The above outer layer part is any one of PFA (perfluoroalkoxy alkane), FEP (tetrafluoroethylene - hexafluoropropylene copolymer), and ETFE (tetrafluoroethylene - ethylene copolymer).

[0346] (Expression 9)

[0347] According to the long medical device described in any one of Expressions 1 to 7,

[0348] The above long medical device is a guide wire.

[0349] (Expression 10)

[0350] According to the long medical device described in Expression 9,

[0351] The outer diameter dimension of the above guide wire is 1 mm or less.

[0352] (Expression 11)

[0353] According to the long medical device described in Expression 9,

[0354] The outer diameter dimension of the above guide wire is 700 μm or less.

[0355] (Expression 12)

[0356] According to the long medical device described in Expression 9,

[0357] The average value of the outer diameter dimension of the above guide wire is 500 - 600 μm.

[0358] (Expression 13)

[0359] According to the long medical device described in any one of Expressions 1 to 7,

[0360] The above long medical device is a catheter.

[0361] Explanation of symbols

[0362] 1, 1A, 1B - guide wire, 1CE - guide wire as a comparative example, 2 - catheter, 11 - base material part, 12 - outer layer part, 13 - concave part, 14 - convex part, 111A, 111B - tubular body, 112A, 112B - intermediate resin layer, 113A, 113B - adhesive layer, 130 - crack.

Claims

1. A long medical device, characterized in that it has: a base material part; and an outer layer part made of resin based on a resin suspension coated on the outer peripheral surface of the above-mentioned base material part, on the surface of the above-mentioned outer layer part, there are irregularly arranged concave parts formed based on the cracks generated by the drying of the above-mentioned resin suspension, and convex parts with an outer peripheral surface formed on the outer peripheral side of the above-mentioned concave parts.

2. A long medical device, characterized in that it has: a base material part; and an outer layer part made of resin provided on the outer peripheral surface of the above-mentioned base material part, on the surface of the above-mentioned outer layer part, there are irregularly arranged concave parts and convex parts with an outer peripheral surface formed on the outer peripheral side of the above-mentioned concave parts, the above-mentioned outer layer part is formed by drying after coating the surface of the above-mentioned base material part with a resin suspension, the above-mentioned concave parts are formed based on the cracks generated by the drying of the suspension coated on the above-mentioned outer layer part.

3. The long medical device according to claim 1 or 2, characterized in that the above-mentioned concave parts are irregularly arranged linearly in the circumferential direction and the major axis direction.

4. The long medical device according to claim 1 or 2, characterized in that the resin suspension forming the above-mentioned outer layer part contains fluororesin particles.

5. The long medical device according to claim 4, characterized in that the above-mentioned fluororesin particles are particles of perfluoroalkoxy alkane.

6. The long medical device according to claim 1 or 2, characterized in that the above-mentioned long medical device is a guide wire, and the guide wire has: the above-mentioned base material part; a first region where a coil member is arranged on the outer circumference of the above-mentioned base material part; and a second region where an outer layer part made of resin is arranged on the outer circumference of the above-mentioned base material part on the proximal end side of the above-mentioned first region, the above-mentioned concave parts are provided in the above-mentioned second region.

7. The long medical device according to claim 1 or 2, characterized in that the above-mentioned base material part has a tubular body and a reinforcing body formed on the outer peripheral side of the above-mentioned tubular body, and the above-mentioned outer layer part covers the above-mentioned tubular body and the above-mentioned reinforcing body.

8. The long medical device according to claim 7, characterized in that there is an adhesive layer on the outer peripheral side of the above-mentioned reinforcing body and between the above-mentioned outer layer part, and the adhesive layer is formed of a resin with improved adhesiveness to the above-mentioned reinforcing body.

9. The long medical device according to claim 8, characterized in that the resin with improved adhesiveness is a fluororesin having an adhesive functional group.

10. The long medical device according to claim 9, characterized in that the fluororesin having the above-mentioned adhesive functional group is perfluoroalkoxy alkane having an adhesive functional group.

11. The long medical device according to claim 1 or 2, characterized in that the above-mentioned base material part has a tubular body, a reinforcing body formed on the outer peripheral side of the above-mentioned tubular body, and an intermediate resin layer formed in such a way as to cover the above-mentioned tubular body and bury the above-mentioned reinforcing body, the above-mentioned outer layer part covers the above-mentioned tubular body and the above-mentioned reinforcing body.

12. The long medical device according to claim 11, characterized in that The above-mentioned intermediate resin layer and the above-mentioned outer layer part are formed of different resins, and an adhesive layer is formed between the above-mentioned intermediate resin layer and the above-mentioned outer layer part, and the adhesive layer is formed of a resin with improved adhesiveness to the above-mentioned intermediate resin layer.

13. The long medical instrument according to claim 12, wherein the resin forming the above-mentioned adhesive layer is a fluororesin having an adhesive functional group.

14. The long medical instrument according to claim 9, wherein the fluororesin having the above-mentioned adhesive functional group is a perfluoroalkoxy alkane having an adhesive functional group.

15. A method for manufacturing a long medical instrument, wherein it has the following steps: a first step of preparing a base material part; a second step of coating a resin suspension on the outer periphery of the above-mentioned base material part; a third step of drying the above-mentioned resin suspension coated on the above-mentioned base material part; and a fourth step of sintering the coating film of the above-mentioned resin suspension, in the above-mentioned third step, cracks are formed in the coating film of the dried above-mentioned resin suspension, and after the above-mentioned fourth step, recesses caused by the above-mentioned cracks are formed on the surface.

16. The method for manufacturing a long medical instrument according to claim 15, wherein between the above-mentioned first step and the above-mentioned second step, there is a fifth step of forming an adhesive layer using a resin with improved adhesiveness to the above-mentioned base material part.

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