Long medical instrument and production method therefor

Abstract

To provide a long medical instrument which improves low friction during passage through a tract tissue, and a production method for the instrument.SOLUTION: A long medical instrument comprises a base material part 11 and an outer layer part 12 which is made of resin derived from a resin suspension that is applied on the outer circumferential surface of the base material part. The surface of the outer layer part has irregularly disposed recesses formed from cracks generated by drying of the resin suspension and protrusions with outer circumferential surfaces formed on the outside of the recesses.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present disclosure relates to elongate medical devices. [Background technology]

[0002] In order to achieve low friction when inserting a long medical device such as a guidewire or catheter into the body, a technique is known in which the surface of the long medical device is coated with a hydrophilic resin or a fluororesin to form irregularities on the surface (Patent Documents 1 and 2). This technique can reduce the contact area between the long medical device and tubular tissue inside the body. When inserting a long medical device into a blood vessel, this technique was effective because in healthy, non-lesioned areas, the blood vessel itself can maintain its tubular structure due to blood pressure, and blood has a relatively low viscosity. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2009 / 081844 [Patent Document 2] JP 2008-125523 A Summary of the Invention [Problem to be solved by the invention]

[0004] We will consider a long medical instrument that can improve low friction when passing through biological tubular tissue with high friction. There are cases where friction is high when inserting a long medical instrument into the body. For example, among biological tubular tissues present in the body, friction is high when inserting a long medical instrument into the body in vascular parts with strong curvatures such as the aortic arch or internal carotid artery, in the digestive tract which is more flexible than normal blood vessels, and in diseased vascular parts or digestive tracts where liquids with higher viscosity than blood are present.

[0005] Therefore, the present disclosure provides a long medical instrument that can improve low friction when passing through biological tubular tissue, and a method for manufacturing the same. [Means for solving the problem]

[0006] A long medical instrument according to one embodiment of the present disclosure has a base portion and an outer layer portion made of resin based on a resin suspension applied to the outer peripheral surface of the base portion, and the surface of the outer layer portion has irregularly arranged recesses formed based on cracks caused by drying of the resin suspension, and protrusions whose outer peripheral surface is formed further outward than the recesses.

[0007] In the present disclosure, "irregularly arranged recesses" refers to recesses that are not formed based on a single or multiple combined predetermined patterns, but rather recesses that are not restricted by a predetermined pattern as a whole. That is, the recesses formed in the resin outer layer of the elongated medical instrument have a predetermined variation in their depth, opening width, and spacing between the multiple recesses that is greater than the variation that occurs during manufacturing.

[0008] A long medical instrument according to another aspect of the present disclosure has a substrate and an outer layer made of resin provided on the outer peripheral surface of the substrate, the surface of the outer layer having irregularly arranged recesses and protrusions having an outer peripheral surface further outward than the recesses, the outer layer being formed by applying a resin suspension to the surface of the substrate and then drying, and the recesses being formed by drying the suspension applied to the outer layer. The recesses may be arranged in a linear, irregular manner in the circumferential and longitudinal directions. The resin suspension forming the outer layer portion may contain fluororesin particles. The fluororesin particles may be perfluoroalkoxyalkane particles.

[0009] The long medical device is a guidewire having a base portion, a first region in which a coil member is arranged on the circumferential outer periphery of the base portion, and a second region on the base end side of the first region in which a resin outer layer portion is arranged on the circumferential outer periphery of the base portion, and the second region may also have a recess.

[0010] The base portion may have a tubular body and a reinforcing body formed on the outer circumferential side of the tubular body, and the outer layer portion may cover the tubular body and the reinforcing body.

[0011] An adhesive layer formed of a resin having enhanced adhesiveness to the reinforcing body may be provided between the outer layer portion and the outer peripheral side of the reinforcing body. The resin with enhanced adhesive properties may be a fluororesin having adhesive functional groups.

[0012] The fluororesin having an adhesive functional group may be a perfluoroalkoxyalkane having an adhesive functional group. The base material portion has a tubular body, a reinforcing body formed on the outer circumferential side of the tubular body, and an intermediate resin layer formed to cover the tubular body and bury the reinforcing body, and the outer layer portion may cover the tubular body and the reinforcing body. The intermediate resin layer and the outer layer may be formed from different resins, and an adhesive layer made of a resin having enhanced adhesiveness to the intermediate resin layer may be formed between the intermediate resin layer and the outer layer. The resin forming the adhesive layer may be a fluororesin having an adhesive functional group. The fluororesin having an adhesive functional group may be a perfluoroalkoxyalkane having an adhesive functional group.

[0013] A manufacturing method for a long medical instrument according to yet another aspect of the present disclosure includes a first step of preparing a base member, a second step of applying a resin suspension to the outer periphery of the base member, a third step of drying the resin suspension applied to the base member, and a fourth step of sintering the resin suspension coating, wherein in the third step, cracks are formed in the dried resin suspension coating, and after the fourth step, recesses due to the cracks are formed on the surface. The resin suspension may include fluororesin particles. The fluororesin particles may be perfluoroalkoxyalkane particles. Between the first and second steps, a fifth step may be included in which an adhesive layer is formed from a resin having enhanced adhesiveness to the base material.

[0014] The resin having enhanced adhesiveness to the substrate may be a fluororesin layer having an adhesive functional group.

[0015] The fluororesin having an adhesive functional group may be a perfluoroalkoxyalkane having an adhesive functional group. Effect of the Invention

[0016] According to the present disclosure, the contact area with tubular tissue inside the body can be reduced. [Brief description of the drawings]

[0017] [Figure 1] 1 is a schematic diagram of a guidewire and a catheter using the guidewire according to an embodiment of the present disclosure. [Diagram 2] 1 is a longitudinal cross-sectional view showing a portion of a guidewire as an example of an elongated medical device. [Diagram 3] 10A to 10C are explanatory views showing a step of forming recesses on the surface of the guidewire. [Figure 4] FIG. 13 is an external view showing a state in which a crack has formed on the surface of a guidewire. [Diagram 5] FIG. 2 is an external view showing an enlarged view of a portion of the guidewire. [Figure 6] FIG. 2 is an external view showing an enlarged portion of a guidewire of a comparative example. [Figure 7] FIG. 1 is a perspective view showing an apparatus for measuring the outer diameter of a guidewire. [Figure 8] 1 is a graph showing data obtained by measuring the outer diameter dimension of a guidewire having a recess in its outer layer portion along the axial direction. [Figure 9] FIG. 9 is a waveform diagram obtained by FFT analysis of the measurement data of FIG. 8. [Figure 10] 9 is a table showing the results of FFT analysis of the measurement data of FIG. 8. [Figure 11] 13 is a table showing the results of measuring the outer diameter of a guidewire having a recess in its outer layer portion. [Figure 12] 13 is a graph showing data obtained by measuring the outer diameter of a guidewire according to a comparative example along the axial direction. [Figure 13] FIG. 13 is a waveform diagram obtained by FFT analysis of the measurement data of FIG. 12. [Figure 14]13 is a table showing the results of FFT analysis of the measurement data of FIG. 12 . [Figure 15] 13 is a table showing the results of measuring the outer diameter of a guidewire according to a comparative example. [Figure 16] 13 is a table showing the results of measuring the outer diameter of a tapered portion of a guide wire. [Figure 17] 13 is a table showing analysis results for another case in which irregular recesses are formed on the surface of a guidewire. [Figure 18] 1 is a graph showing measured external dimensions. [Figure 19] 1 is a graph showing the results of FFT analysis of external dimension measurement data. [Figure 20] 13 is a table showing analysis results for yet another case in which irregular recesses are formed on the surface of a guidewire. [Figure 21] 1 is a graph showing the measured outer diameter dimensions. [Figure 22] 13 is a graph showing the results of FFT analysis of outer diameter measurement data. [Figure 23] 1 is a graph showing a comparison of the sliding resistance between a guidewire having a recess on its surface and a guidewire having no recess on its surface. [Figure 24] FIG. 11 is a longitudinal sectional view of a medical tube according to a second embodiment. [Diagram 25] FIG. 4 is an explanatory diagram showing a step of forming recesses on the surface of a medical tube. [Figure 26] FIG. 11 is a longitudinal sectional view of a medical tube according to a third embodiment. [Figure 27] FIG. 4 is an explanatory diagram showing a step of forming recesses on the surface of a medical tube. [Figure 28] 13 is a table showing the results of FET analysis of measurement data on the distal side of the guide wire according to Example 4. [Figure 29] 13 is a table showing the results of FET analysis of measurement data on the proximal side of the guidewire. [Diagram 30] 13 is a table showing measurement data of a guidewire. [Diagram 31]1 is a table showing data obtained by measuring the change in an outer layer portion (referred to as outer layer resin) excluding a core wire from a guide wire. [Diagram 32] 13 is a table showing measurement data of a guidewire according to another embodiment. [Diagram 33] 1 is a table showing data obtained by measuring the change in an outer layer portion (referred to as outer layer resin) excluding a core wire from a guide wire. [Diagram 34] 13 is a table showing measurement data of a guidewire according to still another embodiment. [Diagram 35] 1 is a table showing data obtained by measuring the change in an outer layer portion (referred to as outer layer resin) excluding a core wire from a guide wire. [Diagram 36] FIG. 31 is an enlarged external view and measurement data of the distal side of the guidewire corresponding to FIG. 30. [Figure 37] FIG. 31 is an enlarged external view and measurement data of the proximal side of the guidewire corresponding to FIG. 30. [Figure 38] FIG. 33 is an enlarged external view of the guidewire corresponding to FIG. 32 and includes measurement data. [Figure 39] FIG. 35 is a magnified view and measurement data corresponding to the guidewire of FIG. 34. [Diagram 40] 1 is a table showing analyzed MPF and MDF values ​​for various guidewires. [Diagram 41] FIG. 41 is an explanatory diagram showing the table of FIG. 40 in the form of a graph. [Diagram 42] 13 is a table showing the analysis of measurement data for the guidewire according to Example 5. [Diagram 43] FIG. 2 is an explanatory diagram showing an enlarged external view of a guidewire having a diameter of 0.79 mm and outer diameter data, etc. [Diagram 44] FIG. 2 is an explanatory diagram showing an enlarged external view of another guidewire having a diameter of 0.79 mm and outer diameter data, etc. [Diagram 45] FIG. 2 is an explanatory diagram showing an enlarged external view of a guidewire having a diameter of 0.70 mm and outer diameter data, etc. [Figure 46]FIG. 2 is an explanatory diagram showing an enlarged external view of a guidewire having a diameter of 0.55 mm and outer diameter data, etc. [Figure 47] FIG. 2 is an explanatory diagram showing an enlarged external view of a guidewire having a diameter of 0.415 mm and outer diameter data, etc. [Figure 48] FIG. 2 is an explanatory diagram showing an enlarged external view of another guidewire having a diameter of 0.415 mm and outer diameter data, etc. [Figure 49] FIG. 13 is an explanatory diagram showing an enlarged external view of yet another guidewire having a diameter of 0.415 mm and outer diameter data, etc. [Figure 50] FIG. 2 is an explanatory diagram showing an enlarged external view of another guidewire having a diameter of 0.415 mm and outer diameter data, etc. [Figure 51] FIG. 13 is an explanatory diagram showing an enlarged external view of yet another guidewire having a diameter of 0.415 mm and outer diameter data, etc. [Figure 52] FIG. 2 is an explanatory diagram showing an example of a blood vessel in which a guidewire is used. [Figure 53] FIG. 13 is an explanatory diagram showing a state in which a guidewire is used in a lower limb blood vessel model. [Figure 54] 1 is a graph showing the MPF when the resin coating speed for a 0.415 mm guidewire is changed. [Figure 55] 1 is a graph comparing the sliding resistance values ​​when a 0.415 mm guidewire is used at a location where the simulated blood vessel is strongly curved and when the simulated blood vessel is gently curved, for different resin coating speeds. [Figure 56] 13 is a table showing the MPF for a number of guidewires created by varying the resin coating speed, and the sliding resistance values ​​when these guidewires are used in a strongly curved portion of a simulated blood vessel. [Figure 57] 13 is a table showing the MPF for a number of guidewires created by varying the resin coating speed, and the sliding resistance values ​​when these guidewires are used in a gently curved portion of a simulated blood vessel. [Figure 58] 58 is a graph comparing the measurement data in FIG. 56 and the measurement data in FIG. 57 based on the type of curvature of the simulated blood vessel. [Figure 59] 1 is a graph showing a comparison of sliding resistance values ​​when a guidewire is coated with PFA and when it is coated with PTFE. [Figure 60] 13 is a table showing the depth dimension of the recess (depth of the wrinkles), MPF, MDF, membrane thickness, and cumulative value of the power value of the catheter of Example 6. [Figure 61] This is an enlarged view of the appearance of the proximal side (labeled tube_top) of the catheter. [Figure 62] 1 is a table showing values ​​of MDF and MPF. [Figure 63] 1 is a graph showing the outer diameter of a catheter along the length of the catheter. [Figure 64] 64 is a graph showing an enlarged portion of FIG. 63. [Figure 65] 13 is a table showing the results of an analysis of data from the proximal side of the catheter. [Figure 66] 13 is a table showing measurement results of outer diameter data on the proximal side of a catheter. [Figure 67] This is an enlarged view of the appearance of the center of the catheter (labeled "tube_middle"). [Figure 68] 1 is a table showing values ​​of MDF and MPF. [Figure 69] 1 is a graph showing the outer diameter of a catheter along the length of the catheter. [Figure 70] 70 is a graph showing an enlarged portion of FIG. 69. [Figure 71] 13 is a table showing the results of analyzing data near the center of the catheter. [Figure 72] 13 is a table showing the measurement results of outer diameter data near the center of the catheter. [Figure 73] This is an enlarged view of the appearance of the distal side (labeled tube_down) of the catheter. [Figure 74] 1 is a table showing values ​​of MDF and MPF. [Figure 75] 1 is a graph showing the outer diameter of a catheter along the length of the catheter. [Figure 76] 76 is a graph showing an enlarged portion of FIG. 75. [Figure 77] 13 is a table showing the results of an analysis of data on the distal side of the catheter. [Figure 78] 13 is a table showing measurement results of outer diameter data on the distal side of a catheter. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] In one aspect of the present disclosure, as described below, a surface of the long medical instrument is provided with a plurality of recesses for reducing the contact area with tubular tissue in the body. The recesses are formed linearly in the circumferential and longitudinal directions. This reduces the frictional resistance of the long medical instrument according to the present disclosure when passing through biological tubular tissue with high friction. Since the long medical instrument according to the present disclosure has a plurality of recesses on its surface, the contact area between the surface of the long medical instrument and the inner wall of a blood vessel can be reduced. Therefore, when the long medical instrument according to the present disclosure is inserted into, for example, a blood vessel part with strong curvature, low friction can be achieved.

[0019] In this embodiment, a resin suspension is applied to the outer peripheral surface of the base material to form an outer layer portion, and the outer layer portion has irregularly arranged recesses formed by drying of the resin suspension, and protrusions whose outer peripheral surfaces are formed on the outer peripheral side of the recesses.

[0020] In one embodiment, the long medical device has a base portion and an outer layer portion made of resin provided on the outer peripheral surface of the base portion, and the surface of the outer layer portion has irregularly arranged recesses and protrusions having an outer peripheral surface formed on the outer peripheral side of the recesses, the outer layer portion being formed by applying a resin suspension to the surface of the base portion and then drying, and the recesses being formed by drying the suspension applied to the outer layer portion.

[0021] The recesses may be formed linearly and irregularly arranged in the circumferential and longitudinal directions of the elongated medical instrument.The resin suspension forming the outer layer portion may contain fluororesin particles.

[0022] The elongated medical instrument of the present disclosure can reduce frictional resistance when inserted into a specific tubular tissue, such as a digestive tract that is more flexible than normal blood vessels, or a diseased blood vessel or digestive tract that contains a liquid with higher viscosity than blood.

[0023] In another aspect of the present disclosure, there is provided a long medical instrument that can improve slidability, in which irregularly arranged recesses on the surface of the outer layer part can reduce the sliding resistance between the long medical instrument and a biological wall that comes into contact with the long medical instrument, such as the inner wall of a blood vessel, or between the long medical instrument and the inner wall of the lumen of another long medical instrument through which the long medical instrument is inserted.

[0024] Hereinafter, an embodiment of the present disclosure will be described. The long medical instrument according to this embodiment is configured as a long medical instrument such as a guidewire 1, 1A or a catheter 2. The long medical instrument has a base material 11, 11A and an outer layer 12, 12A made of resin provided on the surface of the base material 11, 11A. As described later, the recesses 13 are irregularly formed in the circumferential direction and the longitudinal direction of the long medical instrument when the outer layer 12, 12A is formed by applying a resin suspension to the base material 11, 11A. The recesses 13 are irregularly formed based on cracks 130 that are generated when the resin suspension applied to the base material 11, 11A dries. From one viewpoint, the surface of the outer layer 12, 12A is provided with recesses that are irregularly arranged and protrusions 14 whose outer circumferential surface is formed on the outer circumferential side of the recesses.

[0025] From another viewpoint, the elongated medical instrument is a guidewire 1 having a base portion 11, 11A, a first region A1 in which a coil member 23 is disposed on the circumferential outer periphery of the base portion 11, 11A, and a second region A2 in which a resin outer layer portion 12, 12A is disposed on the circumferential outer periphery of the base portion 11, 11A on the base end side (the hand side or proximal side of the surgeon) of the first region A1. The guidewire 1 has a recess in the second region A2.

[0026] The base material portion 11B has a tubular body 111B and a reinforcing body 113B formed on the outer circumferential side of the tubular body 111B, and the outer layer portion 12B may cover the tubular body 111B and the reinforcing body 113B. In yet another aspect, the recesses 13 are irregularly arranged on the substantially flat surface 121 of the outer layer portion 12, 12A. The substantially flat surface 121 is a surface that is flat and has no irregularities except for the recesses 13 according to the present disclosure. In other words, the substantially flat surface 121 is a surface that has no irregularities when the recesses 13 according to the present disclosure are not present. When an elongated medical device such as the guidewire 1 or catheter 2 has an uneven portion such as a coil shape, unevenness appears on the surface corresponding to the uneven portion.

[0027] Therefore, the substantially flat surface 121 may be a surface corresponding to a region where no coil is disposed below the outer layer portion 12, 12A. For example, when the elongated medical device 1 is a balloon catheter, an example of the substantially flat surface 121 is a region on the base end side of the balloon (a region where no balloon is formed). When the elongated medical device 1 is a guidewire, an example of the substantially flat surface 121 is a region on the base end side of the region where a coil is formed at the tip of the guidewire (a region where no coil is provided).

[0028] The scope of the present disclosure also includes cases in which the recesses 13 according to the present disclosure are formed irregularly on a surface other than the substantially flat surface 121. For example, an elongated medical instrument in which recesses 13 are formed on the surface of the outer layer portion 12 corresponding to the coil shape, together with the unevenness resulting from the coil shape, is one type of elongated medical instrument of the present disclosure.

[0029] The shape of the recess 13 may be a linear portion having an indefinite shape. The shape of the recess 13 may include a spatial frequency of 3 to 10 (1 / mm).

[0030] The irregularly arranged (formed) recesses 13 of irregular shape can also be expressed as irregular linear portions 13 formed irregularly on the surfaces of the outer layer portions 12, 12A. Alternatively, the irregular recesses 13 can also be expressed as irregular linear portions 13 originating from cracks 130 occurring in the outer layer portions 12, 12A.

[0031] Therefore, the long medical device of this embodiment may be described as having, for example, a base portion 11, 11A and a resin outer layer portion 12, 12A provided on the surface of the base portion 11, 11A, and in a predetermined region 121 on the surface side of the outer layer portion 12, 12A, a plurality of irregularly formed linear portions 13 of fixed shape are provided, with the linear portions 12 being recessed toward the base portion 11, 11A.

[0032] The long medical device of this embodiment may be described as having, for example, a base portion 11, 11A and a resin outer layer portion 12, 12A provided on the surface of the base portion 11, 11A, and in a predetermined region 121 on the surface side of the outer layer portion 12, 12A, a plurality of irregularly shaped linear portions 13 are formed irregularly due to cracks that have occurred in the outer layer portion 12, 12A, and the linear portions 12 are recessed toward the base portion 11, 11A.

[0033] In this embodiment, the description will be given in terms of a recess formed in a direction in which the outer diameter becomes smaller than the substantially flat surface 121 of the outer layer portion 12, 12A. However, it may also be understood that an irregular protrusion 14 is formed in a direction in which the outer diameter becomes larger than the diameter of the base portion 11, for example.

[0034] Hereinafter, a guidewire 1 will be described as an example of a long medical instrument. However, the present disclosure is not limited to the guidewire 1, and can also be applied to a catheter 2. Irregularly shaped recesses can also be formed in the outer layer provided on the surface of the catheter 2. The present disclosure is applicable not only to the guidewire or catheter 2, but also to long medical members for treatment (e.g., endoscopes) that are inserted into tubular biological tissue such as blood vessels or the digestive tract. EXAMPLES

[0035] Example 1 will be described with reference to Figures 1 to 18. As shown in Figure 1, a catheter 2 is used, for example, to diagnose or treat a stenosis or obstruction. The catheter 2 may be a balloon catheter, a microcatheter, a cardiac catheter, a pulmonary artery catheter, an angiography catheter, a urethral catheter, a digestive catheter, or the like.

[0036] The catheter 2 includes a catheter shaft 21 and a connector 22 joined to the base end side of the catheter shaft 21. The catheter shaft 21 includes, for example, a coil body and a resin tube covering the outside of the coil body (neither is shown). A lumen (not shown) through which the guidewire 1 or another catheter can be inserted is formed on the inner peripheral side of the coil body along the longitudinal direction of the coil body.

[0037] FIG. 2 is an enlarged longitudinal sectional view of the guidewire 1 according to the present embodiment. The guidewire 1 has a core material 11 as an example of a "base material" and an outer layer portion 12 provided in close contact with the surface of the core material 11 so as to cover the surface of the core material 11, and irregularly shaped recesses 13 are formed on the surface of the outer layer portion 12. The guidewire 1 may include a different resin layer (not shown) between the core material 11 and the outer layer portion 12. A coil-shaped portion may be provided on the tip side of the core material 11, but is not shown. FIG. 2 shows an enlarged region of the guidewire 1 where no coil-shaped portion exists. The depth dimension h1 of the recesses 13 is not a constant value but varies. However, the depth dimension h1 of the recesses 13 does not exceed the thickness dimension of the outer layer portion 12. Reference numeral 10 denotes the central axis of the guidewire 1. As shown in FIG. 5, the irregular recesses 13 are wrinkled linear portions formed in a plurality of portions on the surface of the guidewire 1, and are recessed toward the core material 11 side.

[0038] The bottom part of Fig. 2 shows a schematic cross section of the recess 13. Fig. 3 shows a method for forming the recess 13. The following description will be given with reference to Figs.

[0039] In the coating step S1, the core material 11 is dip-coated with a PFA dispersion that is the material of the outer layer portion 12. The PFA dispersion is a suspension in which PFA particles (dispersoid) are dispersed in a dispersion medium such as water. The entire circumference of the core material 11 may be dip-coated over its entire length, or the entire circumference of a predetermined range of the core material 11 may be dip-coated. The dispersoid is not limited to PFA. Any thermoplastic resin with low friction resistance can be used as the material of the outer layer portion 12.

[0040] In the pre-baking step S2, the dip-coated core material 11 is heated at a first temperature TEMP1 for a first time t1 to evaporate the dispersion medium and dry the core material 11. The pre-baking step can also be expressed as a drying step.

[0041] The first temperature TEMP1 may be selected, for example, from a range of temperatures equal to or higher than the evaporation temperature of the dispersion medium and lower than the melting point of the dispersoid (evaporation temperature of the dispersion medium≦TEMP1<melting point of the dispersoid). The first time t1 may be set to a predetermined time required for evaporation of the dispersion medium.

[0042] By applying the suspension to the core material 11 and heating it at the first temperature TEMP1, the dispersion medium evaporates from the surface of the suspension, and the dispersoid solidifies into a film. Inside, the state of the suspension is maintained. On the inner periphery side of the film-like dispersoid on the surface, the dispersion medium in the suspension evaporates from the surface side, and the volume of the suspension decreases, causing a part of the film-like dispersoid on the surface to collapse. While the evaporation of the dispersion medium in the suspension continues, the collapse of the film-like dispersoid on the surface continues, and cracks 130 occur. In the main baking step S3, the dispersion medium is rapidly evaporated by heating at a temperature higher than the first temperature TEMP1. In the main baking step S23, the dispersion medium in the suspension is sufficiently evaporated to such an extent that peeling of the dispersion medium does not occur, and the suspension that will become the outer layer portion 12 in the preliminary baking step S2 is dried. For example, when a suspension containing ethylene glycol is used as the dispersion medium, the cracks 130 occur when the suspension is heated at the first temperature TEMP1 of about 200° C. for about 2 minutes.

[0043] In the pre-firing step S2, cracks 130 occur in the resin outer layer portion 12 provided on the surface of the guide wire 1, as shown in the lower left of FIG. 2. In the lower left of FIG. 2, one crack 130 is enlarged and schematically shown. Actually, as shown in the external view of FIG. 4, a plurality of cracks 130 are formed on the surface of the guide wire 1 after the completion of the pre-firing step S2.

[0044] Returning to FIG. 3, in the main firing step S3, the guide wire 1 with cracks 130 on its surface is main fired by heating it at the second temperature TEMP2 for the second time t2. If the pre-firing step is called a drying step, the main firing step can also be called a firing step. Note that the pre-firing step and the main firing step may be performed continuously in time.

[0045] The second temperature TEMP2 is set higher than the first temperature TEMP1 during pre-firing (TEMP1 < TEMP2). The second temperature TEMP2 is set to be equal to or higher than the melting point of the dispersoid (here, the melting point of PFA).

[0046] The second time t2 can be set to a time such that the resin above the crack 130 melts and flows into the crack 130, and the crack 130 is not completely buried by the resin that has flowed in. Next, the relationship between the first time t1 and the second time t2 will be described. The first time t1, which is the time of pre-firing, may be set to be equal to or greater than the second time t2, which is the time of main firing (t1 ≧ t2). The first time t1 and the second time t2 may be set to the same value or a similar value.

[0047] As shown in the lower right of FIG. 2, a recess 13 is formed when the resin on the surface side of the outer layer portion 12 melts and flows into the crack 130. Since the recess 13 is formed from the crack 130, it has an irregular linear shape similar to the crack 13. The cross-section of the recess 13 is smoother than the cross-section of the crack 130.

[0048] Thus, since the recess 13 is formed from the crack 130 generated in the pre-firing step S2, it becomes an irregular linear recess 13 that occurs irregularly on the surface of the outer layer portion 12. The recess 13 including either or both of a curve and a straight line can also be called a wrinkle shape.

[0049] As described above, Fig. 4 shows an enlarged view of a portion of the surface of the guidewire 1 when the preliminary baking step S2 is completed. Fig. 5 shows an enlarged view of a portion of the surface of the guidewire 1 when the main baking step S3 is completed. Since Figs. 4 and 5 show enlarged views of different locations and at different magnifications, the shape of the crack 130 does not correspond to the shape of the recess 13. However, in reality, as described above, the recess 13 is formed when the surrounding resin melts and flows into the crack 130, so the shape of the crack 130 in plan view and the shape of the recess 13 in plan view roughly correspond to each other. However, small cracks 130 may be filled with the flowing resin.

[0050] Fig. 6 shows an enlarged view of a portion of the guidewire 1CE as a comparative example. The surface of the guidewire 1CE as a comparative example does not have irregular projections and recesses 13. If the guidewire 1CE shown in Fig. 6 is observed at a magnification higher than that of the external view of Fig. 5, projections and recesses will appear on the surface, but these projections and recesses are not formed intentionally.

[0051] 7 shows a measuring device 3 for measuring the outer diameter of the guidewire 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 device 34, a linear actuator 35, and a measurement control device 36. For the outer diameter measuring device 34 and the measurement control device 36, for example, a measuring head LS-9006 and a controller LS-9500 of the ultra-high speed, high precision dimension measuring device LS-9000 series manufactured by Keyence Corporation can be used.

[0052] The frame 31 extends upward from a flat floor surface, and a flat plate portion 32 is attached midway in the vertical direction. An insertion hole 33 through which the guide wire 1 is inserted is formed in the flat plate portion 32. An outer diameter measuring device 34 is disposed around the insertion hole 33. The outer diameter measuring device 34 measures the outer diameter dimension of an object by, for example, laser light, and a light projector and a light receiver are disposed opposite each other with the insertion hole 33 in between.

[0053] A linear actuator 35 is provided vertically on the flat plate portion 32 at a position slightly away from the insertion hole 33. The linear actuator 35 holds one end of the guidewire 1 (the upper end of the guidewire 1 in FIG. 7) and moves vertically upward at a constant speed in accordance with a control signal from the measurement control device 36.

[0054] While the guide wire 1 is being pulled up vertically at a constant speed by the linear actuator 35 , the outer diameter measuring device 34 measures the outer diameter of the guide wire 1 in real time and outputs the result to the measurement control device 36 .

[0055] 7, the measurement may be performed with, for example, a sampling period of 8000 times / sec for outer diameter measurement, a vertical movement speed of 10 mm / sec, and a measurement length of 30 mm. The outer dimension data of the guidewires of this embodiment and the comparative example obtained by such measurements will be described below.

[0056] Fig. 8 is a graph showing the results (raw data) of measuring the outer diameter of a guidewire 1 having irregular, amorphous asperities 13 formed on the surface of an outer layer portion 12, using the diameter measuring device 3 described in Fig. 7. The vertical axis represents the outer diameter (µm), and the horizontal axis represents the position in the longitudinal direction of the guidewire 1. From the graph in Fig. 8, it can be seen that recesses 13 of various recess sizes are irregularly formed on the surface of the guidewire 1 of this embodiment.

[0057] FIG. 9 is a waveform diagram showing the result of FFT analysis of the measurement data shown in FIG. 8. The vertical axis indicates the power value, and the horizontal axis indicates the spatial frequency (1 / mm). According to the waveform diagram of FIG. 9, the waveform showing the irregularities 13 includes spatial frequencies ranging from a lower limit SF1 to an upper limit SF2. The lower limit SF1 is 1 (1 / mm), and the upper limit SF2 is 10 (1 / mm). That is, it was found from experiments that the sliding resistance is reduced when the recesses 13 including a spatial frequency of 1 to 10 (1 / mm) are formed. Furthermore, if the irregularities 13 having various shapes in plan view and cross-sectional shapes are irregularly formed on the surface of the guidewire 1 so as to include a spatial frequency of 3 to 10 (1 / mm), the effect described later in FIG. 18 can be obtained.

[0058] FIG. 10 is a table T1 showing the results of FFT analysis of the outer diameter of the guidewire 1 having the recess 13. As shown in FIG.

[0059] As described in the first row (1) of table T1, the MPF is 5.7232 and the MDF is 5.542 for the guide wire 1 of this embodiment. As described in the second row (2) of table T1, there are 289 pieces of data with power values ​​greater than 0.01.

[0060] The third line (3) to the seventh line (7) of table T1 show the data distribution state when the spatial frequency range for the MPF is changed. As shown in the third line (3), the cumulative value of the power value in the entire spatial frequency range is 7.834504. As shown in the fourth line (4), in the spatial frequency range of plus or minus 4 of the MPF, the cumulative value is 6.24272. The distribution ratio is 80%. As shown in the fifth line (5), in the spatial frequency range of plus or minus 3 of the MPF, the cumulative value is 5.40852. The distribution ratio is 69%. As shown in the sixth line (6), in the spatial frequency range of plus or minus 2 of the MPF, the cumulative value is 3.95915. The distribution ratio is 51%. As shown in the seventh line (7), in the spatial frequency range of plus or minus 1 of the MPF, the cumulative value is 2.10406. Its distribution ratio is 27%, and the difference in ratio 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 53%.

[0061] As shown in the eighth row (8) of table T1, when the spatial frequency is in the range of 3 to 10 (1 / mm), the cumulative value is 5.546508. The distribution ratio is 71%.

[0062] 11 is a table showing the results of measuring the outer diameter of a guidewire 1 having recesses 13 in an outer layer portion 12. The unit is μm. The maximum outer diameter is 573.1, the minimum outer diameter is 556, the median outer diameter is 564.55, the average outer diameter is 567.6373, and the variation of the outer diameter is 2.452621.

[0063] Focusing on the variation of the outer diameter, the maximum value of the variation of the outer diameter relative to the minimum value of the outer diameter is 17, the minimum value of the variation of the outer diameter is 0, and the variation rate of the outer diameter is 3.0%. The variation value of the outer diameter relative to the average value of the outer diameter is 5.362737 to -11.6373, and the variation rate of the outer diameter is +0.94 to -2.05%. The variation value of the outer diameter relative to the median value of the outer diameter is 8.45 to -8.55, and the variation rate of the outer diameter is +1.50 to -1.51%.

[0064] Fig. 12 is a graph showing data obtained by measuring the outer diameter of a guidewire 1CE of a comparative example along the axial direction. The vertical axis shows the outer diameter (µm), and the horizontal axis shows the position along the length of the guidewire 1. It can be seen from the graph in Fig. 12 that the surface of the guidewire 1CE of the comparative example is smooth and free of irregularities, compared to the guidewire shown in Fig. 8.

[0065] Fig. 13 is a waveform diagram showing the results of FFT analysis of the measurement data shown in Fig. 12. The vertical axis indicates power value, and the horizontal axis indicates spatial frequency (1 / mm). The waveform diagram in Fig. 13 shows that there are substantially no irregularities on the surface of the guidewire 1CE as a comparative example.

[0066] FIG. 14 is a table T2 showing the results of FFT analysis of the outer diameter dimension of the guidewire 1CE of the comparative example.

[0067] As shown in the first row (1) of Table T1, the MPF of the comparative guidewire 1CE is 1.064 and the MDF is 0.2441. As shown in the second row (2) of Table T2, there is no data with a power value greater than 0.01. The discrepancy between the MPF and MDF values ​​is due to the fact that the power value varies to an extent that is not visible in the figure at or above 1 (1 / mm) in FIG. 13. Such variation is due to diameter variation caused by processing of the core material 11 of the guidewire, etc.

[0068] The third line (3) to the seventh line (7) of table T2 show the data distribution state when the spatial frequency range for the MPF is changed. As shown in the third line (3), the cumulative value in the entire spatial frequency range is 1.51776. As shown in the fourth line (4), in the spatial frequency range of plus or minus 4 of the MPF, the cumulative value is 0.926171. The distribution ratio is 61%. As shown in the fifth line (5), in the spatial frequency range of plus or minus 3 of the MPF, the cumulative value is 0.861739. The distribution ratio is 57%. As shown in the sixth line (6), in the spatial frequency range of plus or minus 2 of the MPF, the cumulative value is 0.801288. The distribution ratio is 53%. As shown in the seventh line (7), in the spatial frequency range of plus or minus 1 of the MPF, the cumulative value is 0.612517. The distribution ratio is 40%.

[0069] As shown in the eighth row (8) of table T2, when the spatial frequency is in the range of 3 to 10 (1 / mm), the cumulative value is 0.357573. The distribution ratio is 24%.

[0070] 15 is a table showing the results of measuring the outer diameter of the guidewire 1CE. The unit is μm. The maximum outer diameter is 561.7, the minimum outer diameter is 559, the median outer diameter is 560.35, the average outer diameter is 560.1724, and the variation in the outer diameter is 0.662483. Although details are omitted, the surface of the guidewire 1CE of the comparative example does not have the recess 13 of this embodiment and is substantially smooth, so there is almost no variation in the outer diameter.

[0071] A case where the guidewire 1 has a tapered portion will be described with reference to Fig. 16. Fig. 16 is a table showing the results of measuring the outer diameter of the tapered portion of the guidewire 1.

[0072] Although not shown, the guidewire 1 may have a tapered section in which the diameter gradually decreases toward the tip side. In the tapered section of the guidewire 1, a taper is formed in the core material 11, and further, a recess 13 is formed on the surface of the guidewire 1, so that the change in external dimension of the tapered section is larger than the change in external dimension of the non-tapered section. Therefore, in order to find the change in external dimension caused by the formation of the recess 13 in the tapered section, it is necessary to find a value for the change in external dimension corrected to offset the change in diameter of the core material 11.

[0073] Correction for changes in external dimensions is performed by approximating the change in the outer diameter of the core material 11 between the tip and base ends of the tapered portion with a linear function, and then using the inverse function of that linear function, etc., to add or subtract from the outer diameter value depending on the distance from the tip or base end of the tapered portion.

[0074] The upper part of Fig. 16 shows analytical values ​​of measurement data when recesses 13 are irregularly formed on a tapered portion where core material 11 of guidewire 1 reduces in diameter by 8 µm per 10 cm in the longitudinal direction. The lower part of Fig. 16 shows analytical values ​​of measurement data when core material 11 of guidewire 1CE does not have recesses 13 on a tapered portion where core material 11 reduces in diameter by 8 µm per 10 cm in the longitudinal direction. The unit is µm.

[0075] Regarding the upper side of the table, the maximum outer diameter is 570.205, the minimum outer diameter is 550.655, the median outer diameter is 560.43, the average outer diameter is 563.6368, and the variation of the outer diameter is 3.269153.

[0076] Focusing on the variation of the outer diameter, the maximum value of the outer diameter variation relative to the minimum value of the outer diameter 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 relative to the average value of the outer diameter is +6.363237 to -12.6368, and the outer diameter variation rate is +1.13% to -2.24%. The outer diameter variation value relative to the median value of the outer diameter is +9.57 to -9.43, and the outer diameter variation rate is +1.71% to -1.68%.

[0077] Therefore, since the variation in outer dimensions at the tapered portion is greater than when there is no taper, it becomes necessary to correct the outer dimensions at the tapered portion.

[0078] FIGS. 17 to 22 will be explained. FIG. 17 is an analysis result table T3 for another case in which irregular recesses 13 are formed on the surface of the guidewire 1. FIG. 18 is a graph showing the measurements of the outer dimensions. FIG. 19 is a graph showing the results of FFT analysis of the outer dimension measurement data. FIG. 20 is an analysis result table T4 for yet another case in which irregular recesses 13 are formed on the surface of the guidewire 1. FIG. 21 is a graph showing the measurements of the outer dimensions. FIG. 22 is a graph showing the results of FFT analysis of the outer dimension measurement data. Analysis result table T3 and analysis result table T4 are examples in which the resin outer layer 12 is formed to be thicker than the analysis result table T1 of FIGS. 8 to 10.

[0079] As described in the first row (1) of tables T1, T3, and T4, the guide wire 1 having recesses 13 formed therein has an MPF ​​in the range of 4 to 7 and an MDF in the range of 4 to 7. As described in the second row (2), there are at least 100 pieces of data with a power value greater than 0.01.

[0080] As described in the third row (3) to the seventh row (7) of the 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 the median value between the minimum value (70% of T4) of the fourth row (4) of the tables T1, T3, and T4 that form unevenness and the value (61%) of the fourth row (4) of the table T2 that does not have unevenness. The upper limit of the distribution ratio of the spatial frequency of plus or minus 1 is the median value between the maximum value (31% of T3) of the seventh row (7) of the tables T1, T3, and T4 that form unevenness and the value (40%) of the seventh row (7) of the table T2 that does not have unevenness. 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 in the tables with unevenness is 31%.

[0081] As shown in the eighth row (8) of tables T1, T3, and T4, it can be seen that irregular recesses 13 according to this embodiment are formed on the surface of catheter 1 when the spatial frequency is in the range of 3 to 10 (1 / mm).

[0082] FIG. 23 is a graph showing a comparison of the sliding resistance of the guidewire 1 of this embodiment having the recesses 13 on its surface and the sliding resistance of the guidewire 1CE of the comparative example having no recesses on its surface. The vertical axis shows the value of the sliding resistance. In FIG. 23, a simulated environment was used in which an endoscope was inserted from the oral cavity through the esophagus and stomach to the duodenum, and a guidewire was inserted into the endoscope. In the simulated environment, the guidewire 1 and the guidewire 1CE are compared in a case where the guidewire is introduced into an environment in which the guidewire insertion lumen of the endoscope is filled with physiological saline when the endoscope is first inserted into the body, and a case where the guidewire is introduced into an environment in which bile flows back from the endoscope tip and the guidewire is filled with bile after the guidewire is inserted into the endoscope. The shaded bar graph shows the guidewire 1 of this embodiment, and the open bar graph shows the guidewire 1CE of the comparative example. In both simulated experiments, it can be seen that the guidewire 1 of this embodiment having the irregular recesses 13 on its surface has a smaller sliding resistance.

[0083] According to this embodiment configured as above, it is possible to reduce sliding resistance by irregularly arranging the recesses 13 on the substantially flat surface 121 of the outer layer portion 13. In particular, the shape of the recesses includes a shape that appears over a spatial frequency range of 3 to 10 (1 / mm), thereby making it possible to reduce sliding resistance.

[0084] It is clear from the first row (1) of Tables T1 and T3 that the sliding resistance is reduced when at least one of the MDF and MPF has a value of 4 to 7 (1 / mm). Similarly, it is clear from the first row (1) of Tables T1 and T3 that the sliding resistance is reduced when at least one of the MDF and MPF has a value of 5 (1 / mm) or more.

[0085] It is clear from the second row (2) of Tables T1 and T3 that the sliding resistance is reduced when there are at least 10 or more spatial frequencies with a power value of 0.01 or more.

[0086] It is clear from the FFT waveform diagram in FIG. 9 that the sliding resistance is reduced when spatial frequencies with power values ​​of 0.01 or more are distributed over a range of 1 to 10 (1 / mm).

[0087] It is clear from the seventh row (7) of Tables T1 and T3 that the sliding resistance is reduced when the distribution ratio within the range of plus or minus 1 (1 / mm) of the average frequency component value is less than 35%.

[0088] It is clear from the fourth row (4) of Tables T1 and T3 that the sliding resistance is reduced when the distribution ratio within the range of plus or minus 4 (1 / mm) of the average frequency component value is approximately 80% or more.

[0089] It is clear from the ratio difference in the seventh row (7) of Tables T1 and T3 that sliding resistance is reduced when the difference between the distribution ratio of the average frequency component value of plus or minus 1 (1 / mm) and the distribution ratio of plus or minus 4 (1 / mm) is approximately 50% or more.

[0090] It is clear from the eighth row (8) of Table T1 that the sliding resistance is reduced when the power spectrum of spatial frequencies 3 to 10 (1 / mm) is 50% or more. Similarly, it is clear from the eighth row (8) of Table T1 that the sliding resistance is reduced when the power spectrum of spatial frequencies 3 to 10 (1 / mm) is 70% or more.

[0091] It is clear from the outer diameter fluctuation rate in FIG. 11 that the sliding resistance is reduced when the outer diameter fluctuation rate with respect to the minimum outer diameter value is 3% or more.

[0092] It is clear from the graphs of Figures 8, 18, and 22 that the sliding resistance is reduced when there are 10 or more locations with outer diameter changes of less than 1 mm in width and 5 µm or more within a range of 1 CEm in the major axial direction.

[0093] When outer layer portion 12 includes a tapered portion, if the outer diameter fluctuation rate excluding the outer diameter change due to the tapered portion is 3% or more relative to the minimum outer diameter value, the sliding resistance is reduced, as is clear from the measurement results when recess 13 is formed in the tapered portion shown in the upper part of Figure 16. EXAMPLES

[0094] Other embodiments will be described below. In the present disclosure, for example, attention is given to the following aspects.

[0095] Even in a blood vessel, a highly viscous atheroma may occur at the lesion. When the atheroma enters 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 atheroma, causing friction.

[0096] The digestive tract, another tubular tissue in the body, is filled with digestive fluids that are more viscous than normal blood. When the digestive fluids enter the recesses 13 on the surface of the long medical instrument, friction is generated due to contact between the surface of the recesses 13 of the long medical instrument and the digestive fluids.

[0097] The wall of the digestive tract is highly flexible, and the inner diameter of the digestive tract decreases due to peristalsis. For this reason, even a long medical instrument having recesses 13 and protrusions 14 on its surface generates friction between the wall of the digestive tract. If the distance between the protrusions 14 (or the distance between the recesses 13) formed on the long medical instrument is long, when the long medical instrument is inserted into the digestive tract, the flexible surface of the digestive tract penetrates into and comes into contact with the recesses 13, generating friction.

[0098] The recesses 13 can be formed on the surface of the long medical instrument using a resin suspension containing a fluororesin. In this case, there is a possibility that the adhesion between the fluororesin and the component formed on its inner periphery may decrease. The component formed on the inner periphery of the fluororesin is a metal structure or another type of resin such as urethane. That is, as described above, when a wrinkled outer layer 12 in which linear recesses 13 are irregularly arranged is formed on the surface of the base 11, there is a possibility that the adhesion between the base 11 and the outer layer 12 may decrease.

[0099] In view of the above-mentioned points, the present disclosure employs the following configurations. Note that at least a part of the following configurations is also described in the first embodiment or substantially described therein.

[0100] As described above, the linear recesses 13 are formed due to cracks that occur when the resin suspension dries. That is, when the resin suspension applied to the surface of the elongated medical instrument dries, cracks occur irregularly, and the recesses 13 are formed due to the cracks.

[0101] The linear recesses 13 are formed over a range of 90 degrees or more in the circumferential direction of the elongated medical instrument, and are irregularly arranged in the circumferential direction and the longitudinal direction. The recesses 13 may be formed over the entire circumference of the elongated medical instrument.

[0102] The recesses 13 are formed in the resin outer layer 12 that forms the surface of the elongated medical instrument, and the depth of the recesses 13 is formed to be within ±7% to ±25% of the average thickness of the outer layer 12.

[0103] An adhesive layer can also be provided between the outer layer portion 12 in which the recesses 13 are formed and the base material portion 11. That is, a fluororesin having adhesive functional groups is formed as an adhesive layer between the metal structure or another type of resin on the inner periphery side of the resin suspension that forms the recesses 13, and the adhesive layer is then coated on the outer periphery side of the adhesive layer. Alternatively, the outer layer portion 12 in which the recesses 13 are formed may be formed from a resin suspension of a fluororesin having adhesive functional groups. With this configuration, it is possible to increase the adhesion between the outer layer portion 12 and the base material portion 11.

[0104] Since the present disclosure employs the above-described configuration, it has the following advantages.

[0105] When a long medical instrument is inserted into a normal blood vessel, the contact area of ​​the surface of the long medical instrument with the inner wall of the blood vessel is reduced because the recesses 13 are formed on the surface of the long medical instrument, thereby realizing low friction when inserting the long medical instrument into the blood vessel.

[0106] Since normal, low-viscosity blood that passes through before reaching the diseased blood vessel is retained within the linear recess 13, the intrusion of atheromatous thrombus into the recess 13 in the diseased blood vessel is inhibited, thereby reducing friction on the surface of the long-axis medical device.

[0107] When the long medical instrument is inserted into a tubular tissue such as the digestive tract, highly viscous liquid components such as digestive juices enter the linear recess 13. In this case, the liquid components with low viscosity (water) predominantly seeps out into the deep part (bottom part) of the recess 13. Therefore, it is possible to prevent the highly viscous liquid components from entering the deep part of the recess 13, and to reduce friction between the surface of the long medical instrument and the tubular tissue.

[0108] Since the recesses 13 are formed in the circumferential and longitudinal directions of the elongated medical instrument, even if a highly viscous liquid component enters the recesses 13, at least a part of the liquid component can be moved from the entry point in the circumferential and / or longitudinal directions of the elongated medical instrument. By moving at least a part of the highly viscous liquid component that has entered the recesses 13 to a location other than the recesses 13, friction between the surface of the elongated medical instrument and the tubular tissue can be reduced.

[0109] The linear recesses 13 are irregularly arranged in the circumferential direction and / or the longitudinal direction of the surface of the elongated medical device, which reduces the possibility that the irregularities on the surface of soft body tissue such as the digestive tract will coincide with the recesses 13 and protrusions 14 formed on the surface of the elongated medical device over a certain distance. This reduces the contact area between the surface of the body tissue and the surface of the elongated medical device, thereby reducing friction on the surface of the elongated medical device.

[0110] An adhesive layer made of a fluororesin having adhesive functional groups that bond to a metal structure or another type of resin is provided between the outer layer portion 12 and the base material portion 11, so that the fluororesin of the adhesive layer and the fluororesin of the outer layer portion 12 are compatible bonded to each other. This makes it possible to improve the adhesion between the base material portion 11 made of a metal structure or another type of resin and the outer layer portion 12 in which the recesses 13 are formed.

[0111] This disclosure includes a description of a method for manufacturing 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 by a specially prepared unevenness forming process of physical processing or chemical processing. The specially prepared unevenness forming process is a process of pressing a pattern for forming unevenness while the outer layer resin of the long medical instrument retains its softness, a process of grinding the surface of the outer layer resin after the outer layer resin has hardened to form unevenness, or a process of partially dissolving the surface of the outer layer resin to form unevenness. In the prior art, a special dedicated process is prepared just for creating unevenness on the surface of the long medical instrument, which complicates the manufacturing process of the long medical instrument.

[0112] In contrast, in the elongated medical instrument according to the present disclosure, in the process of drying the resin suspension applied to the base material, cracks are formed in the dried resin suspension coating, and then the resin suspension coating is sintered to form recesses due to the cracks. That is, in the manufacturing method of the elongated medical instrument according to the present disclosure, recesses 13 are formed in a series of processes for forming outer layer portion 12.

[0113] As long as it is possible to form cracks by drying the resin suspension after application, the type of resin and the medium are not important.

[0114] In order to reduce friction when inserting the long medical instrument into the body, the resin type may be a fluororesin or a hydrophilic resin. Perfluoroalkoxyalkane may also be used as the fluororesin.

[0115] From the viewpoints of availability, ease of drying, and safety, the medium may be water, alcohol, or a mixed liquid containing water or alcohol as a main component.

[0116] When the resin suspension contains a fluororesin, an adhesive layer made of a fluororesin having adhesive functional groups may be formed before the resin suspension is applied to the substrate portion of the elongated medical instrument.

[0117] According to the manufacturing method of the long medical instrument of the present disclosure, since there is no need to prepare a special process dedicated solely to forming irregularities on the surface of the long medical instrument, the manufacturing process of the long medical instrument can be prevented from becoming complicated. According to the manufacturing method of the long medical instrument of the present disclosure, since an adhesive layer is formed between the outer layer portion 12 and the base portion 11, it is possible to improve the adhesion between the base portion 11 and the outer layer portion 12 made of a fluororesin formed from a resin suspension.

[0118] Example 2 will be described with reference to Figures 24 and 25. Example 2 and Example 3 described below will be described taking a medical tube as an example of a long medical instrument. This medical tube 1A can be used, for example, as a sheath for a digestive basket. The medical tube 1A can also be used for other catheters.

[0119] The medical tube 1A has a substrate portion 11A and an outer layer portion 12A. The substrate portion 11A comprises a tubular body 111A and an intermediate resin layer 112A provided on the outer circumferential side of the tubular body 111A. An adhesive layer 113A is provided on the outer circumferential surface of the intermediate resin layer 112A to improve adhesion to the inner circumferential surface of the outer layer portion 12A. The adhesive layer 113A may be considered to be part of the substrate portion 11A.

[0120] The surface of the outer layer portion 12A is formed with recesses 13 and protrusions 14. The recesses 13 and protrusions 14 can be considered to be two sides of the same coin. In other words, when imagining a flat surface of the outer layer portion 12A, the areas where the recesses 13 do not exist can be considered to be the protrusions 14. The following explanation will focus on the recesses 13. The recesses 13 are formed as short lines extending in the circumferential and longitudinal directions of the medical tube 1A, and are irregularly arranged. The actual appearance will be described later.

[0121] FIG. 25 shows a method for manufacturing a medical tube 1A. In a first step S11, a PFA tube 111A is provided as a "tubular body" on the outer circumferential surface of a core bar 100A by extrusion molding. The PFA tube 111A is subjected to a surface treatment. The surface treatment of the PFA tube 111A is, for example, a treatment for increasing the adhesion between the PFA tube 111A and an intermediate resin layer 112A. In a second step S12, an intermediate resin layer 112A made of PTFE is formed by coating the outer circumferential surface of the PFA tube 111A with a PTFE solution or by providing a PTFE tube on the outer periphery of the PFA tube 111A by extrusion molding. An adhesive layer 113A can also be provided on the surface of the intermediate resin layer 112A.

[0122] The material of the intermediate resin layer 112A is not limited to polytetrafluoroethylene (PTFE), but may be at least one selected from the group consisting of PTFE, tetrafluoroethylene-perfluoroalkylvinylether copolymer (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), nylon, and urethane.

[0123] When nylon or polyurethane is used as the intermediate resin layer 112A, a fluororesin having an adhesive functional group can be used as an adhesive layer to improve the adhesion between nylon or polyurethane and PFA. That is, a fluororesin having an adhesive functional group (also called adhesive fluororesin) can be used as an adhesive layer 113A between nylon or polyurethane and PFA.

[0124] In the third process S13, a PFA solution is coated on the outer peripheral surface of the intermediate resin layer 112A (or on the outer peripheral surface of the adhesive layer 113A if the adhesive layer 113A is provided on the outside of the intermediate resin layer 112A), and drying and baking are performed as described in Example 1.

[0125] In the fourth step S14, the core metal 100A is pulled out to form the medical tube 1A. EXAMPLES

[0126] Example 3 will be described with reference to Figures 26 and 27. Medical tube 1B has a substrate portion 11B and an outer layer portion 12B. Substrate portion 11B includes a tubular body 111B and an intermediate resin layer 112B provided on the outer circumferential side of tubular body 111B. An adhesive layer 113B is provided on the outer circumferential surface of intermediate resin layer 112B to improve adhesion with the inner circumferential surface of outer layer portion 12B. Adhesive layer 113B may be considered to be a part of substrate portion 11B. Intermediate resin layer 112B may include a reinforcing member 114B.

[0127] The surface of outer layer portion 12B is formed with recesses 13 and protrusions 14. Recesses 13 are formed as short lines extending in the circumferential and longitudinal directions of medical tubing 1B and are irregularly arranged. The actual appearance will be described later.

[0128] 27 shows a method for manufacturing a medical tube 1B. In a first step S21, a PFA tube 111B is provided as a "tubular body" on the outer circumferential surface of a core bar 100B by extrusion molding. The PFA tube 111B is subjected to a surface treatment. In the second step S22, a reinforcing member 114B is provided on the outer periphery of the PFA tube 111B.

[0129] In the third step S23, the reinforcing body 114B is embedded in the PTFE solution to form an intermediate resin layer 112B made of PTFE.

[0130] In the fourth step S24, an adhesive layer 113B is provided on the surface of the intermediate resin layer 112B.

[0131] In the fifth step S25, a PFA solution is coated on the outer peripheral surface of the adhesive layer 113B, and then drying and baking are performed in the same manner as described in Example 1 to form an outer layer portion 12B in which the recesses 13 and 14 are to be formed.

[0132] In a sixth step S26, the core metal 100B is pulled out to form the medical tube 1B. EXAMPLES

[0133] Example 4 will be described with reference to Figures 28 to 41. Example 4 and Example 5 described below will be described taking a guidewire as an example of the long medical instrument.

[0134] FIG. 28 is a table T11 obtained by performing an FET analysis on the measurement data for the distal side of the guidewire according to the fourth embodiment.

[0135] As shown in the first row (1) of table T11, at the distal side of the guidewire, the MPF is 3.6613 and the MDF is 3.0762. As shown in the second row (2) of table T11, there are 38 data points with power values ​​greater than 0.01.

[0136] The third line (3) to the seventh line (7) of table T11 show the data distribution state when the spatial frequency range for the MPF is changed. As shown in the third line (3), the cumulative value of the power value in the entire spatial frequency range is 1.784349. As shown in the fourth line (4), in the spatial frequency range of plus or minus 4 of the MPF, the cumulative value is 1.462841. The distribution ratio is 82%. As shown in the fifth line (5), in the spatial frequency range of plus or minus 3 of the MPF, the cumulative value is 0.928622. The distribution ratio is 52%. As shown in the sixth line (6), in the spatial frequency range of plus or minus 2 of the MPF, the cumulative value is 0.695964. The distribution ratio is 39%. As shown in the seventh line (7), in the spatial frequency range of plus or minus 1 of the MPF, the cumulative value is 0.418422. Its distribution ratio is 23%, and the difference in ratio 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 59%.

[0137] As shown in the eighth row (8) of table T11, when the spatial frequency is in the range of 3 to 10 (1 / mm), the cumulative value is 0.888071. The distribution ratio is 50%.

[0138] FIG. 29 is a table T12 obtained by performing an FET analysis on the measurement data for the proximal side of the guidewire according to the fourth embodiment.

[0139] As shown in the first row (1) of table T12, on the proximal side of the guidewire, the MPF is 1.7521 and the MDF is 0.7568. As shown in the second row (2) of table T12, there are 64 data points with power values ​​greater than 0.01.

[0140] The third line (3) to the seventh line (7) of table T12 show the data distribution state when the spatial frequency range for the MPF is changed. As shown in the third line (3), the cumulative value of the power value in the entire spatial frequency range is 2.819703. As shown in the fourth line (4), in the spatial frequency range of plus or minus 4 of the MPF, the cumulative value is 2.701526. The distribution ratio is 96%. As shown in the fifth line (5), in the spatial frequency range of plus or minus 3 of the MPF, the cumulative value is 2.616764. The distribution ratio is 93%. As shown in the sixth line (6), in the spatial frequency range of plus or minus 2 of the MPF, the cumulative value is 2.361196. The distribution ratio is 84%. As shown in the seventh line (7), in the spatial frequency range of plus or minus 1 of the MPF, the cumulative value is 0.683675. Its distribution ratio is 24%, and the difference in ratio 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%.

[0141] As shown in the eighth row (8) of table T21, when the spatial frequency is in the range of 3 to 10 (1 / mm), the cumulative value is 0.64181. The distribution ratio is 23%.

[0142] 30 is a table T13 showing measurement data of a guidewire, the distal diameter of which is 0.70 mm and the proximal diameter of which is 0.79 mm.

[0143] The upper side of table T13 shows the measurement data on the distal side, and the lower side of table T13 shows the measurement data on 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.

[0144] FIG. 31 is a table T14 showing data obtained by measuring the change in outer layer portion 12 (referred to as outer layer resin) excluding the core wire from the guidewire.

[0145] The guide wire comprises a core wire as a base material portion 11 and an outer layer resin as an outer layer portion 12 provided on the outside of the core wire. Irregularly arranged recesses 13 are formed on the surface of the outer layer resin. The core wire itself does not affect the formation of the recesses 13. Therefore, in this embodiment, the depth of the recesses 13 relative to the thickness of the outer layer resin layer that can form the recesses 13 is shown.

[0146] The upper side of table T14 shows the measurement data of the outer layer resin on the distal side, and the lower side of table T14 shows the measurement data of the outer layer resin on the proximal side. The measurement data includes the maximum outer layer resin thickness, the minimum outer layer resin thickness, the median outer layer resin thickness, the average outer layer resin thickness (all in μm), the maximum outer layer resin thickness variation, the minimum outer layer resin thickness variation, and the outer layer resin thickness variation rate. In the figure, the outer layer resin thickness is referred to as resin thickness.

[0147] From table T14, it can be seen that the maximum recess depth (relative to the minimum value) is in the range of 17% to 85% of the total outer layer resin thickness. If a recess having a depth that is 100% of the outer layer resin thickness were formed, peeling of the outer layer resin would occur starting from that recess. Therefore, a recess 13 that does not reach 100% of the outer layer resin thickness would be formed.

[0148] 32 is table T15 showing measurement data of a guidewire of another embodiment. The diameter of this guidewire is 0.53 mm. The measurement data recorded in table T15 includes the maximum outer diameter, minimum outer diameter, median outer diameter, and average outer diameter (all in μm), as well as the maximum outer diameter fluctuation, minimum outer diameter fluctuation, and outer diameter fluctuation rate.

[0149] 33 is table T16 showing data obtained by measuring only the variation in the outer layer (referred to as outer layer resin) of the guidewire described in T15. The measurement data for the outer layer resin thickness includes the maximum outer layer resin thickness, the minimum outer layer resin thickness, the median outer layer resin thickness, the average outer layer resin thickness (all in μm), as well as the maximum variation in the outer layer resin thickness, the minimum variation in the outer layer resin thickness, and the variation rate of the outer layer resin thickness.

[0150] 34 is table T17 showing measurement data of a guidewire of still another embodiment. The diameter of this guidewire is 0.53 mm, and the diameter is the same on the distal side, the central part, and the proximal side. The measurement data recorded in table T17 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.

[0151] 35 is table T18 showing data obtained by measuring only the variation in the outer layer (referred to as outer layer resin) of the guidewire described in T17. The measurement data for the outer layer resin thickness includes the maximum outer layer resin thickness, the minimum outer layer resin thickness, the median outer layer resin thickness, the average outer layer resin thickness (all in μm), as well as the maximum variation in the outer layer resin thickness, the minimum variation in the outer layer resin thickness, and the variation rate of the outer layer resin thickness.

[0152] Figure 36 shows measurement data and an enlarged external view of the distal side of the guidewire corresponding to Figure 30. Figure 36 shows, from the top, original data of the outer diameter dimension (horizontal axis in mm, vertical axis in μm), waveform data obtained by FET analysis of the original data of the outer diameter dimension (horizontal axis in Hz, vertical axis in amplitude), waveform data obtained by enlarging the amplitude of the waveform data from the FET analysis, and the external appearance.

[0153] As shown in the external appearance, a plurality of recesses 13 are formed on the surface of the guidewire over a range of 90 degrees or more in the circumferential direction. Focusing on the shape, it can be seen that the recesses 13 are a mixture of shapes, such as linear, S-shaped or inverted S-shaped, meandering, and curved shapes.

[0154] Figure 37 shows measurement data and an enlarged external view of the proximal side of the guidewire corresponding to Figure 30. Many of the recesses 13 are independent of each other. However, recesses 13b connecting adjacent recesses are also seen.

[0155] FIG. 38 shows measurement data and an enlarged external view of the guidewire corresponding to FIG.

[0156] FIG. 39 shows measurement data and an enlarged external view corresponding to the guidewire of FIG.

[0157] FIG. 40 is a table T19 showing the values ​​of MPF and MDF analyzed for the multiple guidewires described in FIG. 36 to FIG. 39. In FIG. 40, the "current product" and the "tip coater" are obtained by applying a resin suspension by a method such as dipping to the whole or part of the core wire cut to a predetermined length to be used as a guidewire, and then drying and sintering the core wire. The "current product" and the "tip coater" are capable of forming an outer layer and a recess 13 on a part of the core wire. For example, after an outer layer coil is attached to the tip of the guidewire, it is possible to form an outer layer and a recess 13 only on the base end side of the guidewire, excluding the area where the outer layer coil is attached. The "continuous coater" is obtained by applying a resin suspension to a core wire wound in a roll, drying and sintering the core wire, and then winding the core wire in a roll again. In the "continuous coater", the outer layer and the recess 13 are formed on the whole core wire having a certain diameter, and in the manufacture of the guidewire, the core wire is cut to a predetermined length and a diameter reduction process is performed by grinding the tip, etc., so that the outer layer is removed in the range where the diameter reduction process is performed. It is shown that whichever manufacturing method is adopted in manufacturing the guidewire, the outer layer and the recess 13 are formed on the base end side relative to the region where the outer layer coil is attached.

[0158] FIG. 41 is an explanatory diagram showing table T19 of FIG. 40 in the form of a graph. EXAMPLES

[0159] Example 5 will be described with reference to Figures 42 to 59. In this example, a case will be described in which recesses are formed on the surface of a guidewire that is thinner than the guidewires described thus far.

[0160] 42 is table T21 obtained by analyzing the measurement data of the guidewire according to Example 5. In table T21, measurement data of guidewires with diameters of 0.79 mm, 0.70 mm, and 0.55 mm are shown, as well as measurement data of a guidewire with diameter of 0.415 mm. Furthermore, for the guidewire with diameter 0.415 mm, table T21 lists the case where wrinkles (depressions 13) are formed and the case where wrinkles are not formed.

[0161] In Example 5, the speed V (referred to as the coating speed or outer layer resin formation speed) at which the resin that becomes the outer layer portion 12 is coated on the surface of the guidewire is changed, and the occurrence of the recesses 13 is measured.

[0162] The measurement data in table T21 includes the depth of the recess 13 (denoted as "wrinkle depth"), MPF, MDF, film thickness, and cumulative power value. Here, the wrinkle depth is defined as half the difference between the concave and convex portions of the outer diameter data. When comparing the wrinkle depth, MPF, and MDF of a guidewire with a diameter of 0.55 mm with the wrinkle depth, MPF, and MDF of a guidewire with a diameter of 0.415 mm on which wrinkles are formed, there is no significant difference between the MPF and MDF of the guidewire with a diameter of 0.55 mm and the MPF and MDF of the guidewire with a diameter of 0.415 mm. Therefore, it can be considered that the wrinkle depth does not affect the MPF and MDF.

[0163] When comparing the cumulative power values ​​of the guidewires of each diameter, the cumulative power value of the guidewire in which no wrinkles were formed is much lower than the cumulative power values ​​of the other guidewires. Therefore, it is considered that the depth of the wrinkles can be estimated to some extent from the cumulative power value.

[0164] Fig. 43 is an explanatory diagram showing an enlarged external view of a guidewire with a diameter of 0.79 mm and outer diameter data, etc. Fig. 43 shows, from the top, the external view of the guidewire, a graph of the outer diameter data of the guidewire, a graph of the outer diameter data enlarged in the X-axis direction, frequency distribution, and a table containing MPF and MDF values. The table containing the MPF and MDF values ​​has almost the same structure as tables T11 and T12 described in Figs. 28 and 29. The table is shown enlarged at the bottom of Fig. 43.

[0165] The vertical axis of the graph for outer diameter data is in μm and the maximum scale is "860". The horizontal axis of the graph for outer diameter data is in mm and the maximum scale is "30". The maximum scale of the horizontal axis of the graph expanded in the X-axis direction is "5.0". The MPF of this guidewire is 5.10 and the MDF is 4.81.

[0166] Figure 44 shows an enlarged view of another guidewire with a diameter of 0.79 mm and its outer diameter data. The MPF of this guidewire is 6.13 and the MDF is 6.03.

[0167] Figure 45 shows an enlarged view and data of a 0.70 mm diameter guidewire. The MPF of this guidewire is 6.90 and the MDF is 6.91.

[0168] Figure 46 shows an enlarged view and data of a guidewire with a diameter of 0.55 mm. The MPF of this guidewire is 4.72 and the MDF is 4.52.

[0169] Figure 47 shows an enlarged view and data of a guidewire with a diameter of 0.415 mm coated with resin at a coating speed of V1. The MPF of this guidewire is 4.37 and the MDF is 4.08.

[0170] Figure 48 shows an enlarged view and data of a guidewire with a diameter of 0.415 mm coated with resin at a coating speed of V3. The MPF of this guidewire is 3.53 and the MDF is 0.51.

[0171] Figure 49 shows an enlarged view and data of a guidewire with a diameter of 0.415 mm coated with resin at a coating speed of V4. The MPF of this guidewire is 3.80 and the MDF is 0.49.

[0172] Figure 50 shows an enlarged view and data of a guidewire with a diameter of 0.415 mm coated with resin at a coating speed of V5. The MPF of this guidewire is 2.58 and the MDF is 0.44.

[0173] Figure 51 shows an enlarged view and data of a guidewire with a diameter of 0.415 mm coated with resin at a coating speed of V2. The MPF of this guidewire is 1.88 and the MDF is 0.12.

[0174] The resin coating speed will be explained. The resin coating speed is the speed at which a resin coating that becomes the outer layer portion 12 is formed on the surface of the guidewire (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 a relationship of V1>V3>V4>V5>V2. From the experimental results of the embodiment 5, it can be seen that when the coating speed is V2 or less, the recesses 13 are not formed on the surface of the outer layer portion 12. It can be seen that the recesses 13 are more likely to be formed as the coating speed increases beyond V2. Therefore, the embodiment 5 discloses, for example, that "by applying a resin suspension to the surface of the base portion 11 at a predetermined speed or more, recesses 13 are formed and arranged irregularly based on cracks caused by drying of the resin suspension" are provided.

[0175] FIG. 52 is an explanatory diagram showing an example of a blood vessel in which a guidewire is used. The simulated blood vessel model M1 is formed, for example, to simulate a state in which a bent lesion occurs in the common iliac artery. Here, the bend Ra is called a gentle curved portion. The simulated blood vessel that realizes the gentle curved portion can be called a gentle curved simulated Ra.

[0176] FIG. 53 shows a lower limb blood vessel model M2 in which a strongly curved portion Rb is formed. The radius of curvature of the strongly curved portion Rb is smaller than the radius of curvature of the gently curved portion Ra (Rb <Ra)。

[0177] FIG. 54 is a graph showing the difference in MPF ​​when the resin coating speed is changed for a 0.415 mm guidewire.

[0178] FIG. 55 is a graph comparing the sliding resistance of a 0.415 mm guidewire when used at a location where the simulated blood vessel is strongly curved and when used at a location where the simulated blood vessel is gently curved, for each resin coating speed.

[0179] From Figures 54 and 55, it can be seen that the faster the coating speed, the larger the MPF value and the smaller the sliding resistance value tend to be. Furthermore, it can be seen that there is a negative correlation between the MPF and the sliding resistance value. The MPF is the average frequency, and this is because the frequency is detected as the number of wrinkles (unevenness). Therefore, a large MPF value means that there are more wrinkles, and it is thought that the more wrinkles there are, the better the sliding properties will be.

[0180] FIG. 56 is a table showing the MPFs for a number of guidewires created by varying the resin coating speed, and the sliding resistance values ​​when these guidewires are used in the strongly curved section Rb of a simulated blood vessel.

[0181] FIG. 57 is a table showing the MPF for several guidewires created by changing the resin coating speed, and the sliding resistance values ​​when these several guidewires are used in the gently curved section Ra of a simulated blood vessel.

[0182] FIG. 58 is a graph comparing the measurement data in FIG. 56 and the measurement data in FIG. 57 in terms of the types of curvature Ra and Rb of the simulated blood vessel.

[0183] It can be seen from Figs. 56 to 58 that the sliding resistance value of the guide wire at the gently curved portion Ra is smaller than the sliding resistance value of the guide wire at the strongly curved portion Rb.

[0184] FIG. 59 is a graph showing a comparison of the sliding resistance value when the guidewire is coated with PFA and the sliding resistance value when the guidewire is coated with PTFE.

[0185] In Figure 59, the sliding resistance values ​​of a PFA coated guidewire having wrinkles (depressions 13) on its surface and a PTFE coated guidewire having no wrinkles on its surface are compared for different strengths of curved section.

[0186] The average thicknesses of the PFA coating are shown as 13.3 μm and 14.8 μm for the guidewires, and the average thicknesses of the PTFE coating are shown as 15.3 μm and 15.8 μm for the guidewires.

[0187] 59 shows that by forming wrinkles (depressions 13) on the surface of the resin layer that becomes outer layer 12, the sliding resistance value of the PFA-coated guidewire with wrinkles is smaller than the sliding resistance value of the PTFE-coated guidewire without wrinkles. Furthermore, the dynamic friction coefficient, which is a mechanical property of fluororesin, is greater for the PFA-coated guidewire without wrinkles than for the PTFE-coated guidewire without wrinkles. In Fig. 59, wrinkles are formed on the surface of the PFA resin layer, and compared with a PTFE resin layer without wrinkles as a comparative example, but the present disclosure does not exclude the formation of wrinkles and the decrease in sliding resistance in resin layers other than PFA. These are also included in the scope of the present disclosure. EXAMPLES

[0188] Example 6 will be described with reference to Figures 60 to 78. In Example 6, the results obtained when the recesses 13 are irregularly formed on the surface of the catheter will be described.

[0189] FIG. 60 is a table showing the depth dimension of the recess (depth of the wrinkles), MPF, MDF, membrane thickness, and cumulative value of the power value of the catheter of Example 6.

[0190] In this table, the wrinkle depth, MPF, MDF, membrane thickness, and cumulative power values ​​are shown for the proximal side of a 2 mm diameter medical tube (catheter), the middle part of a 2 mm diameter medical tube (catheter), the distal side of a 2 mm diameter medical tube (catheter), a 0.79 mm diameter guidewire, a 0.70 mm diameter guidewire, a 0.55 mm diameter guidewire, a 0.415 mm diameter guidewire (with wrinkles on the surface), and a 0.415 mm diameter guidewire (without wrinkles on the surface). The data for the guidewires is the same as that shown in Figure 42.

[0191] Figure 61 is an enlarged view of the appearance of the proximal side of the catheter (labeled tube_top). It can be seen that the recesses 13 are formed in a mesh pattern. Figure 62 is a table showing the MDF and MPF values. Figure 63 is a graph showing the outer diameter of the catheter along the length of the catheter. Figure 64 is a graph showing an enlarged portion of Figure 63. Figure 65 is a table showing the results of analyzing data on the proximal side of the catheter. Figure 66 is a table showing the measurement results of outer diameter data on the proximal side of the catheter.

[0192] FIG. 67 is an enlarged view of the appearance of the catheter near the center (labeled "tube_middle"). FIG. 68 is a table showing the values ​​of MDF and MPF. FIG. 69 is a graph showing the outer diameter of the catheter along the length of the catheter. FIG. 70 is a graph showing an enlarged portion of FIG. 69. FIG. 71 is a table showing the results of analyzing data near the center of the catheter. FIG. 72 is a table showing the measurement results of outer diameter data near the center of the catheter.

[0193] FIG. 73 is an enlarged view of the appearance of the distal side of the catheter (labeled Tube_down). FIG. 74 is a table showing the values ​​of MDF and MPF. FIG. 75 is a graph showing the outer diameter of the catheter along the length of the catheter. FIG. 76 is a graph showing an enlarged portion of FIG. 75. FIG. 77 is a table showing the results of analyzing data on the distal side of the catheter. FIG. 78 is a table showing the measurement results of outer diameter data on the distal side of the catheter.

[0194] Although the embodiments of the present disclosure have been described above, the present disclosure is not limited to these embodiments and various modifications are possible.

[0195] The above-mentioned embodiments have been described in detail to clearly explain the present invention, and are not necessarily limited to those including all of the configurations described. Also, a part of the configuration of one embodiment can be replaced with the configuration of another embodiment. Also, the configuration of another embodiment can be added to the configuration of one embodiment. Also, a part of the configuration of each embodiment can be added, deleted, or replaced with another configuration.

[0196] Furthermore, the technical features included in the above-described embodiments can be combined as appropriate, without being limited to the combinations explicitly stated in the claims.

[0197] The present disclosure includes configurations as shown in the following expressions: (Expression 1) A long medical instrument, A substrate portion, an outer layer portion made of a resin and formed by applying a resin suspension to a surface of the base material portion; The surface of the outer layer portion has linear recesses formed in the circumferential direction and / or the longitudinal direction due to cracks irregularly generated by drying of the resin suspension, and protrusions that form an outer peripheral surface on the outer periphery of the recesses. Long medical instruments.

[0198] (Expression 2) 2. The elongate medical device of claim 1, The suspension contains fluororesin particles. Long medical instruments.

[0199] (Expression 3) 3. The elongate medical instrument according to claim 2, The fluororesin particles are any one of PFA (perfluoroalkoxyalkane), FEP (tetrafluoroethylene-hexafluoropropylene copolymer), and ETFE (tetrafluoroethylene-ethylene copolymer). Long medical instruments.

[0200] (Expression 4) 4. The elongate medical device of claim 1, The waveform formed by the recesses on the surface of the outer layer portion has a spatial frequency of 3 to 10 (1 / mm). Long medical instruments.

[0201] (Expression 5) 5. The elongate medical device of claim 1, A long medical instrument that satisfies at least one of the following (Condition 1) to (Condition 9) when a measurement result of an outer diameter dimension along the longitudinal direction of the outer layer portion is analyzed by FFT (Fast Fourier Transform). (Condition 1) At least one of the median power frequency (MDF) or mean power frequency (MPF) is between 4 and 7 (1 / mm). (Condition 2) At least one of the MDF or MPF values ​​is 5 (1 / mm) or more. (Condition 3) There are at least 100 spatial frequencies with a power value of 0.01 or more. (Condition 4) Spatial frequencies with power values ​​of 0.01 or more are present in a range of 1 to 10 (1 / mm) (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%. (Condition 6) The distribution ratio within the range of ±4 (1 / mm) of the average frequency component value is approximately 70% or more. (Condition 7) The difference between the distribution ratio of the average frequency component value at plus or minus 1 (1 / mm) and the distribution ratio at plus or minus 4 (1 / mm) is approximately 40% or more. (Condition 8) The power spectrum of the spatial frequency range from 3 to 10 (1 / mm) is 50% or more. (Condition 9) The power spectrum of the spatial frequency range from 3 to 10 (1 / mm) is 65% or more.

[0202] (Expression 6) 5. The elongate medical device of claim 1, A long medical instrument, the outer diameter dimension of which measured along the longitudinal direction of the outer layer portion satisfies at least one of the following (Condition 10) or (Condition 11). (Condition 10) The outer diameter fluctuation rate relative to the minimum outer diameter value is 3% or more. (Condition 11) Within a range of 1 cm along the longitudinal axis, there are 10 or more locations where the outer diameter changes by 5 μm or more and is less than 1 mm in width.

[0203] (Expression 7) 7. The elongate medical device according to claim 6, In the condition 10, when the outer layer portion includes a tapered portion, the outer diameter fluctuation rate excluding the outer diameter change due to the tapered portion is 3% or more with respect to the minimum outer diameter value. Long medical instruments.

[0204] (Expression 8) An elongated medical device according to any one of claims 1 to 7, The elongated medical device includes a base portion and a coil member disposed on an outer circumferential surface of the base portion. and a second region in which a resin outer layer portion is disposed on a circumferential outer periphery of the base portion at a proximal end side of the first region, The recess is provided in the second region. Long medical instruments.

[0205] (Expression 9) 9. The elongate medical device according to claim 8, The outer diameter of the guidewire is 1 mm or less. Long medical instruments.

[0206] (Expression 10) 10. The elongate medical device of claim 9, The outer diameter of the guidewire is 700 μm or less. Long medical instruments.

[0207] (Expression 11) 10. The elongate medical device of claim 9, The average outer diameter of the guidewire is 500 to 600 μm. Long medical instruments.

[0208] (Expression 12) An elongated medical device according to any one of claims 1 to 7, The elongated medical device is a catheter. Long medical instruments.

[0209] (Expression 13) An elongated medical device according to any one of claims 1 to 7, the elongate medical device is a catheter; The base material portion has a tubular body, a reinforcing body formed on an outer circumferential side of the tubular body, and an intermediate resin layer formed to cover the tubular body and bury the reinforcing body, The outer layer portion covers the tubular body and the reinforcing body. Long medical instruments. [Explanation of symbols]

[0210] 1, 1A, 1B: guide wire, 1CE: guide wire as a comparative example, 2: catheter, 11: base material, 12: outer layer, 13: recess, 14: protrusion, 111A, 111B: tubular body, 112A, 112B: intermediate resin layer, 113A, 113B: adhesive layer, 130: crack

Claims

1. A long medical instrument, A substrate portion, an outer layer portion made of a resin and formed by applying a resin suspension to a surface of the base material portion; The surface of the outer layer portion has linear recesses formed in the circumferential direction and / or the longitudinal direction due to cracks irregularly generated by drying of the resin suspension, and protrusions that form an outer peripheral surface on the outer periphery of the recesses. Long medical instruments.

2. 2. The elongated medical device according to claim 1, The suspension contains fluororesin particles. Long medical instruments.

3. 3. The elongated medical device according to claim 2, The fluororesin particles are any one of PFA (perfluoroalkoxyalkane), FEP (tetrafluoroethylene-hexafluoropropylene copolymer), and ETFE (tetrafluoroethylene-ethylene copolymer). Long medical instruments.

4. The elongated medical device according to any one of claims 1 to 3, The waveform formed by the recesses on the surface of the outer layer portion has a spatial frequency of 3 to 10 (1 / mm). Long medical instruments.

5. The elongated medical device according to any one of claims 1 to 4, A long medical instrument that satisfies at least one of the following (Condition 1) to (Condition 9) when a measurement result of an outer diameter dimension along the longitudinal direction of the outer layer portion is analyzed by FFT (Fast Fourier Transform). (Condition 1) Median Power Frequency (MDF). Hereinafter referred to as MDF) or Mean Power Frequency (MPF). At least one of the values ​​of the MPF (hereinafter referred to as MPF) is 4 to 7 (1 / mm) (Condition 2) At least one of the MDF and MPF values ​​is 5 (1 / mm) or more. (Condition 3) There are at least 100 spatial frequencies with a power value of 0.01 or more. (Condition 4) Spatial frequencies with power values ​​of 0.01 or more are present at a range of 1 to 10 (1 / mm). (Condition 5) The distribution ratio within the range of ±1 (1 / mm) of the average frequency component value is less than 35%. (Condition 6) The distribution ratio within the range of ±4 (1 / mm) of the average frequency component value is approximately 70% or more. (Condition 7) The difference between the distribution ratio of the average frequency component value at ±1 (1 / mm) and the distribution ratio at ±4 (1 / mm) is approximately 40% or more. (Condition 8) The power spectrum of the spatial frequency range of 3 to 10 (1 / mm) is 50% or more. (Condition 9) The power spectrum of the spatial frequency range of 3 to 10 (1 / mm) is 65% or more.

6. The elongated medical device according to any one of claims 1 to 4, A long medical instrument, wherein a measurement result of an outer diameter dimension along the longitudinal direction of the outer layer portion satisfies at least one of the following (Condition 10) or (Condition 11). (Condition 10) The outer diameter fluctuation rate relative to the minimum outer diameter value is 3% or more. (Condition 11) Within a range of 1 cm in the longitudinal direction, there are 10 or more locations where the outer diameter changes by 5 μm or more and is less than 1 mm in width.

7. The elongated medical device according to claim 6, In the condition 10, when the outer layer portion includes a tapered portion, the outer diameter fluctuation rate excluding the outer diameter change due to the tapered portion is 3% or more with respect to the minimum outer diameter value. Long medical instruments.

8. The elongated medical device according to any one of claims 1 to 7, The elongated medical device includes a base portion and a coil member disposed on an outer circumferential surface of the base portion. and a second region in which a resin outer layer portion is disposed on a circumferential outer periphery of the base portion at a proximal end side of the first region, The recess is provided in the second region. Long medical instruments.

9. 9. The elongate medical device of claim 8, The outer diameter of the guide wire is 1 mm or less. Long medical instruments.

10. 10. The elongate medical device of claim 9, The outer diameter of the guidewire is 700 μm or less. Long medical instruments.

11. 10. The elongate medical device of claim 9, The average outer diameter of the guidewire is 500 to 600 μm. Long medical instruments.

12. The elongated medical device according to any one of claims 1 to 7, The elongated medical device is a catheter. Long medical instruments.

13. The elongated medical device according to any one of claims 1 to 7, the elongate medical device is a catheter; The base material portion has a tubular body, a reinforcing body formed on an outer circumferential side of the tubular body, and an intermediate resin layer formed to cover the tubular body and bury the reinforcing body, The outer layer portion covers the tubular body and the reinforcing body. Long medical instruments.

Images