Long medical equipment

Abstract

The elongated medical device includes a base portion and an outer layer portion made of resin provided on a surface of the base portion, and the substantially flat surface of the outer layer portion has irregularly arranged concave portions or convex portions.

Description

Technical Field

[0001] The present disclosure relates to an elongated medical device. Background Art

[0002] A technique is known in which the surface of a guide wire is coated with a fluororesin and a plurality of fine protrusions are formed on the surface of the fluororesin coating to reduce frictional resistance with the inner surface of a catheter or the inner wall of a blood vessel (Patent Documents 1 and 2).

[0003] Prior art literature

[0004] Patent Literature

[0005] Patent Document 1: International Publication No. 2009 / 081844

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

[0007] Problems to be solved by the invention

[0008] The prior art has room for improvement in slidability.

[0009] Therefore, the present disclosure provides an elongated medical device capable of improving slidability.

[0010] Solutions to Solve Problems

[0011] To achieve the object, a long medical device according to one aspect of the present disclosure includes: a base portion; and a resin outer layer portion provided on a surface of the base portion, wherein the substantially flat surface of the outer layer portion has irregularly arranged recessed portions.

[0012] It is preferable that the substantially flat surface is a surface corresponding to a region where no coil is arranged on the lower side of the outer layer portion.

[0013] The shape of the recessed portion is preferably a linear portion of an irregular shape.

[0014] It is preferable that the shape of the recessed portion has a spatial frequency of 3 to 10 (1 / mm).

[0015] A preferably elongated medical device comprises: a substrate portion; and a resin outer layer portion arranged on the surface of the substrate portion, wherein the substantially flat surface of the outer layer portion has irregularly arranged recesses, and when the measurement results of the outer diameter dimension of the outer layer portion along the long axis direction are subjected to FFT (Fast Fourier Transform) analysis, at least any one of the following (Condition 1) to (Condition 9) is satisfied.

[0016] (Condition 1) Mean Power Frequency (MDF, hereinafter referred to as MDF) or Mean Power Frequency (MDF) Frequency: MPF. The following are: (Condition 2) at least one of the values ​​of MPF is 4 to 7 (1 / mm), (Condition 3) at least one of the values ​​of MDF or MPF is 5 (1 / mm) or more, (Condition 4) at least 10 spatial frequencies with power values ​​of 0.01 or more exist, (Condition 5) the distribution ratio of the average frequency component value in the range of plus or minus 1 (1 / mm) is less than 35%, (Condition 6) the distribution ratio of the average frequency component value in the range of plus or minus 4 (1 / mm) is about 70% or more, (Condition 7) the difference between the distribution ratio of the average frequency component value in the range of plus or minus 1 (1 / mm) and the distribution ratio of plus or minus 4 (1 / mm) is about 40% or more, (Condition 8) the power spectrum of the spatial frequency of 3 to 10 (1 / mm) is 50% or more, (Condition 9) the power spectrum of the spatial frequency of 3 to 10 (1 / mm) is 70% or more.

[0017] Preferably, a long medical device comprises: a substrate portion; and a resin outer layer portion arranged on the surface of the substrate portion, wherein the substantially flat surface of the outer layer portion has irregularly arranged recesses, and the measurement result of the outer diameter dimension of the outer layer portion along the long axis direction satisfies at least any one of the following (Condition 10) and (Condition 11).

[0018] (Condition 10) The outer diameter variation rate relative to the minimum outer diameter value is greater than 3%, and (Condition 11) Within a range of 1 cm in the long axis direction, the outer diameter variation of 5 μm or more exists in more than 10 locations within a range of 3 cm in the long axis direction.

[0019] Preferably, in Condition 10, when the outer layer portion includes a tapered portion, the outer diameter variation rate excluding the outer diameter variation due to the tapered portion is 3% or more with respect to the minimum outer diameter value.

[0020] The outer layer is preferably made of PFA (perfluoroalkoxyalkane), FEP (tetrafluoroethylene-hexafluoropropylene copolymer), or ETFE (tetrafluoroethylene-ethylene copolymer).

[0021] Preferably, the elongated medical device is a guide wire.

[0022] The outer diameter of the guide wire is preferably 1 mm or less.

[0023] The outer diameter of the guide wire is preferably 700 μm or less.

[0024] It is preferred that the average value of the outer diameter of the guide wire is 500 to 600 μm.

[0025] Preferably the elongate medical device is a catheter.

[0026] Effects of the Invention

[0027] According to the present disclosure, by irregularly arranging the recesses on the surface of the outer layer, it is possible to reduce the sliding resistance between biological walls such as the inner wall of the blood vessel in contact with the long medical device, or the sliding resistance between other long medical devices and the inner wall of the lumen through which the long medical device is inserted. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 It is a schematic diagram of a guide wire and a catheter using the guide wire according to an embodiment of the present disclosure.

[0029] Figure 2 It is a longitudinal cross-sectional view showing a part of a guide wire as an example of a long medical instrument.

[0030] Figure 3 It is an explanatory diagram showing the process of forming a recessed portion on the surface of the guide wire.

[0031] Figure 4 This is an external view showing a state in which cracks are formed on the surface of the guide wire.

[0032] Figure 5 This is an enlarged external view showing a portion of the guide wire.

[0033] Figure 6 This is an enlarged external view showing a part of the guide wire of the comparative example.

[0034] Figure 7 It is a perspective view showing a device for measuring the outer diameter of a guide wire.

[0035] Figure 8 This is a graph of data obtained by measuring the outer diameter of a guide wire having a recessed portion in the outer layer portion along the axial direction.

[0036] Fig. 9 Yes Figure 8 This is a waveform diagram of the measured data after FFT analysis.

[0037] Fig.10 Yes means Figure 8 A table showing the FFT analysis results of the measurement data.

[0038] Fig.11 This is a table showing the results of measuring the outer diameter of a guide wire having a recessed portion in the outer layer portion.

[0039] Fig.12 This is a graph of data obtained by measuring the outer diameter of a guide wire of a comparative example in the axial direction.

[0040] Fig.13 Yes Fig.12This is a waveform diagram of the measured data after FFT analysis.

[0041] Fig.14 Yes means Fig.12 A table showing the FFT analysis results of the measurement data.

[0042] Fig.15 This is a table showing the results of measuring the outer diameter dimensions of the guide wires of the comparative examples.

[0043] Fig.16 This is a table showing the results of measuring the outer diameter dimension of the tapered portion of the guide wire.

[0044] Fig.17 This is a table of analysis results for other cases where irregular recesses are formed on the surface of the guide wire.

[0045] Fig.18 This is a chart showing measured external dimensions.

[0046] Fig.19 This is a graph showing the FFT analysis results of the external dimension measurement data.

[0047] Fig. 20 This is a table of analysis results regarding another case where irregular recesses are formed on the surface of the guide wire.

[0048] Fig.21 This is a graph showing the measured outer diameter dimensions.

[0049] Fig. 22 This is a graph showing the FFT analysis results of the outer diameter measurement data.

[0050] Fig.23 This is a graph showing a comparison of the sliding resistance of a guide wire having recessed portions on the surface and a guide wire having no recessed portions on the surface. DETAILED DESCRIPTION

[0051] The following is a description of an embodiment of the present disclosure. The elongated medical device of the present embodiment is configured as an elongated medical device such as a guide wire 1 or a catheter 2. The elongated medical device has a base portion 11 and a resin outer layer portion 12 provided on the surface of the base portion 11, and a substantially flat surface 121 of the outer layer portion 12 has irregularly arranged recesses 13.

[0052] The substantially flat surface 121 is a flat surface without any unevenness except for the concave portion 13 of the present disclosure. In other words, the substantially flat surface 121 is a surface without any unevenness when the concave portion 13 of the present disclosure does not exist. When a long medical device such as a guide wire 1 or a catheter 2 has an uneven portion such as a coil shape, the surface corresponding to the uneven portion has unevenness.

[0053] Therefore, the substantially flat surface 121 may also be a surface corresponding to an area where no coil is arranged on the lower side of the outer layer 12. For example, when the long medical device 1 is a balloon catheter, one example is that the area closer to the base end than the balloon (the area where no balloon is formed) is a substantially flat surface 121. When the long medical device 1 is a guide wire, one example is that the area closer to the base end than the area where the coil is formed at the front end of the guide wire (the area where no coil is arranged) is a substantially flat surface 121.

[0054] The scope of the present disclosure also includes the case where the concave portion 13 of the present disclosure is irregularly formed on a surface other than the substantially flat surface 121. For example, a long medical device is one of the long medical devices of the present disclosure, and the surface of the outer layer 12 corresponding to the coil shape is formed with concave and convex caused by the coil shape, and the concave portion 13 is formed.

[0055] The shape of the recessed portion 13 may be a linear portion of an irregular shape. The shape of the recessed portion 13 may include a spatial frequency of 3 to 10 (1 / mm).

[0056] The irregularly arranged (formed) irregularly shaped recesses 13 may also be expressed as irregularly shaped linear portions 13 irregularly formed on the surface of the outer layer portion 12. Alternatively, the irregularly shaped recesses 13 may also be expressed as irregularly shaped linear portions 13 caused by cracks generated in the outer layer portion 12.

[0057] Therefore, the elongated medical device of the present embodiment is preferably manifested as, for example, having a substrate portion 11 and a resin outer layer portion 12 arranged on the surface of the substrate portion 11, and a predetermined area 121 on the surface side of the outer layer portion 12 is provided with a plurality of irregularly formed linear portions 13 of irregular shape and a linear portion 12 recessed toward the substrate portion 11.

[0058] The long medical device of this embodiment is preferably manifested as, for example, having a base portion 11 and a resin outer layer portion 12 arranged on the surface of the base portion 11, and a predetermined area 121 on the surface side of the outer layer portion 12 is provided with a plurality of irregularly shaped linear portions 13 irregularly formed due to cracks generated in the outer layer portion 12, and a linear portion 12 recessed toward the base portion 11.

[0059] As for this embodiment, the recessed portion formed in the direction in which the outer diameter becomes smaller relative to the substantially flat surface 121 of the outer layer portion 12 is described as a reference, but it can also be fully understood that, for example, an irregular convex portion 14 is formed in the direction in which the outer diameter becomes larger relative to the diameter of the base material portion 11.

[0060] Hereinafter, as a long medical device, a guide wire 1 is used as an example for explanation. However, the present disclosure is not limited to the guide wire 1, and can also be applied to the catheter 2. It is also possible to irregularly form irregularly shaped recesses in the outer layer portion provided on the surface of the catheter 2. The present disclosure can be applied not only to the guide wire or the catheter 2, but also to a long medical component (such as an endoscope) for treatment inserted into a tubular biological tissue such as a blood vessel or a digestive tract.

[0061] Example 1

[0062] use Figures 1 to 18 Example 1 is described. Figure 1 As shown, the catheter 2 is used, for example, to diagnose or treat a stenosis or blockage. The catheter 2 may also be a balloon catheter, a microcatheter, a cardiac catheter, a pulmonary artery catheter, an angiography catheter, a urethral catheter, a digestive organ catheter, or the like.

[0063] The catheter 2 includes a catheter shaft 21 and a connecting tube 22 connected to the base end side of the catheter shaft 21. The catheter shaft 21 includes, for example, a coil body and a resin tube (not shown) covering the outside of the coil body. On the inner circumference of the coil body, a lumen (not shown) is formed throughout the length direction of the coil body through which the guide wire 1 or other catheters can be inserted.

[0064] Figure 2 1 is an enlarged longitudinal sectional view of the guide wire 1 of the present embodiment. The guide wire 1 has a core material 11 as an example of a "base material portion", and an outer layer portion 12 provided closely to cover the surface of the core material 11, and irregular recesses 13 of irregular shape are irregularly formed on the surface of the outer layer portion 12. The guide wire 1 may also include different resin layers, not shown, etc. between the core material 11 and the outer layer portion 12. In addition, a coil-shaped portion is sometimes provided on the front end side of the core material 11, but the illustration is omitted. Figure 2 The area of ​​the guide wire 1 where the coiled portion does not exist is shown in an enlarged manner. The depth dimension h1 of the recess 13 is not a constant value but varies. However, the depth dimension h1 of the recess 13 does not exceed the thickness dimension of the outer layer portion 12 .

[0065] like Figure 5 As shown, the irregular-shaped recessed portion 13 is a plurality of corrugated linear portions formed on the surface of the guide wire 1 , and is recessed toward the core material 11 side.

[0066] exist Figure 2 The lower side of FIG. 1 shows a schematic cross-section of the recess 13 . Figure 3 The method of forming the recess 13 is shown in FIG. Figure 2 as well as Figure 3 Provide explanation.

[0067] In the coating step S1, the core material 11 is dip-coated with a PFA dispersion that is the material of the outer layer 12. The PFA dispersion is a suspension in which particles (dispersoids) of PFA are dispersed in a dispersion medium such as water. The core material 11 can be dip-coated over the entire length or over a predetermined range of the core material 11. The dispersoid is not limited to PFA. Any thermoplastic resin or resin with little friction resistance can be used as the material of the outer layer 12.

[0068] In the calcining step S2, the core material 11 dipped in water is heated at the first temperature TEMP1 for the first time t1, thereby evaporating the dispersion medium and drying the core material 11. The calcining step can also be referred to as a drying step.

[0069] The first temperature TEMP1 can be selected from a temperature range of, for example, a temperature not less than the evaporation temperature of the dispersion medium and less than the melting point of the dispersoid (evaporation temperature of the dispersion medium ≤ TEMP1 < melting point of the dispersoid). The first time t1 can be set as a predetermined time required for evaporation of the dispersion medium.

[0070] Through the temporary firing step S2, Figure 2 As shown in the lower left of FIG. , a crack 130 is generated in the resin outer layer 12 provided on the surface of the guide wire 1. Figure 2 In the lower left of FIG. 1 , a crack 130 is shown schematically and magnified, but in reality, Figure 4 As shown in the external view of FIG. 1 , a plurality of cracks 130 are formed on the surface of the guide wire 1 after the calcining step S2 is completed.

[0071] return Figure 3 In the formal firing step S3, the guide wire 1 having the cracks 130 on the surface is heated at the second temperature TEMP2 for the second time t2 to perform formal firing. If the temporary firing step is called a drying step, the formal firing step can also be called a firing step. In addition, the temporary firing step and the formal firing step can also be performed continuously in time.

[0072] The second temperature TEMP2 is set higher than the first temperature TEMP1 during the calcination (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).

[0073] The second time t2 can be set to a time at which the resin on the upper side of the crack 130 melts and flows into the crack 130, and the crack 130 is not completely buried by the flowing resin. Next, the relationship between the first time t1 and the second time t2 is described. The first time t1 as the time of temporary firing can be set to be greater than the second time t2 as the time of formal firing (t1≥t2). The first time t1 and the second time t2 can be set to the same value or approximate values.

[0074] like Figure 2 As shown in the lower right of the figure, the resin on the surface side of the outer layer 12 melts and flows into the crack 130, thereby forming the recess 13. The recess 13 is formed in a manner from the crack 130, and thus becomes a linear shape of an irregular shape similar to the crack 13. Compared with the cross-section of the crack 130, the cross-section of the recess 13 becomes gentle.

[0075] Thus, the recessed portion 13 is formed from the crack 130 generated in the calcining step S2, and thus becomes an irregular linear recessed portion 13 generated irregularly on the surface of the outer layer portion 12. The recessed portion 13 including either or both of a curve or a straight line can also be called a wrinkle shape.

[0076] As mentioned above, Figure 4 A part of the surface of the guide wire 1 at the end of the calcining step S2 is shown in an enlarged manner. Figure 5 A portion of the surface of the guide wire 1 at the end of the main firing step S3 is shown in an enlarged manner. Figure 4 and Figure 5 The magnification is different in different places, so the shape of the crack 130 does not correspond to the shape of the recess 13, but in fact, as described above, the surrounding resin melts and flows into the crack 130, thereby forming the recess 13, so the shape of the crack 130 when viewed from above roughly corresponds to the shape of the recess 13 when viewed from above. However, there is a possibility that a small crack 130 is buried by the flowing resin.

[0077] Figure 6 A portion of a guide wire 1C as a comparative example is shown in an enlarged manner. The irregular concavities and convexities 13 are not formed on the surface of the guide wire 1C as a comparative example. Figure 5 High magnification observation of the appearance diagram Figure 6 The guide wire 1C shown has irregularities on its surface, but these irregularities are not intentionally formed.

[0078] Figure 7 The figure shows a measuring device 3 for measuring the outer diameter of the guide wire 1. The outer diameter measuring device 3 includes, for example, a frame 31, a flat plate portion 32 having an insertion hole 33, an outer diameter measuring device 34, a linear actuator 35, and a measuring control device 36. For example, the outer diameter measuring device 34 and the measuring control device 36 can use the measuring head LS-9006 and the controller LS-9500 of the LS-9000 series of ultra-high-speed and high-precision dimension measuring devices of KEYENCE Corporation.

[0079] The frame 31 extends upward from the flat ground, and a flat plate portion 32 is installed midway in the vertical direction. The flat plate portion 32 is formed with an insertion hole 33 for inserting the guide wire 1. An outer diameter measuring device 34 is arranged around the insertion hole 33. The outer diameter measuring device 34 measures the outer diameter of the object by laser, for example, and a light projector and a light receiver are arranged opposite to each other across the insertion hole 33.

[0080] A linear actuator 35 is vertically provided 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 guide wire 1 (at Figure 7 The guide wire 1 is shown in the center, and moves vertically upward at a constant speed according to a control signal from the measurement control device 36.

[0081] While the guide wire 1 is pulled up in the vertical direction 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 measured value to the measurement control device 36 .

[0082] use Figure 7 The measuring device 3 can be used, for example, to measure the outer diameter at a sampling period of 8000 times / second, a vertical moving speed of 10 mm / second, and a measuring length of 30 mm. The external dimension data of the guide wire of the present embodiment and the comparative example obtained by the measurement will be described below.

[0083] Figure 8 It means to use Figure 7 The outer diameter measurement device 3 described in the figure is used to measure the outer diameter of the guide wire 1 having irregularly formed irregularly shaped bumps 13 on the surface of the outer layer 12. The vertical axis represents the outer diameter (μm), and the horizontal axis represents the position in the longitudinal direction of the guide wire 1. Figure 8 As can be seen from the graph, various recessed portions 13 are irregularly formed on the surface of the guide wire 1 of the present embodiment.

[0084] Fig. 9 Yes Figure 8 The waveform diagram of the measurement data shown is the result of FFT analysis. The vertical axis represents the power value, and the horizontal axis represents the spatial frequency (1 / mm). Fig. 9 The waveform diagram shows that the waveform of the concave-convex 13 includes a spatial frequency 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 is found from experiments that if a concave portion 13 having a spatial frequency of 1 to 10 (1 / mm) is formed, the sliding resistance is reduced. Furthermore, if concave-convex 13 having various shapes when viewed from above and in cross-sectional shape is irregularly formed on the surface of the guide wire 1 in a manner including a spatial frequency of 3 to 10 (1 / mm), it can be obtained that Fig.18The effect described later.

[0085] Fig.10 Table T1 shows the results of FFT analysis of the outer diameter of the guide wire 1 having the recessed portion 13 .

[0086] As shown in the first row (1) of Table T1, in the guide wire 1 of this embodiment, the MPF is 5.7232 and the MDF is 5.542. As shown in the second row (2) of Table T1, there are 289 data with power values ​​greater than 0.01.

[0087] The third row (3) to the seventh row (7) of Table T1 show the data distribution when the range of spatial frequency relative to MPF is changed. As shown in the third row (3), the cumulative value of the power value in the entire spatial frequency range is 7.834504. As shown in the fourth row (4), in the range of spatial frequency of positive or negative 4 of MPF, the cumulative value becomes 6.24272. Its distribution ratio is 80%. As shown in the fifth row (5), in the range of spatial frequency of positive or negative 3 of MPF, the cumulative value becomes 5.40852. Its distribution ratio is 69%. As shown in the sixth row (6), in the range of spatial frequency of positive or negative 2 of MPF, the cumulative value is 3.95915. Its distribution ratio is 51%. As shown in the seventh row (7), in the range of spatial frequency of positive or negative 1 of MPF, the cumulative value is 2.10406. Its distribution ratio is 27%, and the difference between the distribution ratio of spatial frequency of positive or negative 4 and the distribution ratio of spatial frequency of positive or negative 1 is 53%.

[0088] As shown in the eighth row (8) of Table T1, in the range of spatial frequency from 3 to 10 (1 / mm), the cumulative value is 5.546508, and its distribution ratio is 71%.

[0089] Fig.11 This is a table showing the results of measuring the outer diameter of the guide wire 1 having the recess 13 in the outer layer 12. The unit is μm. The maximum value of the outer diameter is 573.1, the minimum value of the outer diameter is 556, the median value of the outer diameter is 564.55, the average value of the outer diameter is 567.6373, and the variation value of the outer diameter is 2.452621.

[0090] If we focus on the change in the outer diameter, the maximum value of the outer diameter change relative to the minimum value of the outer diameter is 17, the minimum value of the outer diameter change is 0, and the outer diameter change rate is 3.0%. The outer diameter change value relative to the average value of the outer diameter is 5.362737 to -11.6373, and the outer diameter change rate is +0.94 to -2.05%. The outer diameter change value relative to the median value of the outer diameter is 8.45 to -8.55, and the outer diameter change rate is +1.50 to -1.51%.

[0091] Fig.12 Graph showing data of the outer diameter of the guide wire 1C of the comparative example measured along the axial direction. The vertical axis represents the outer diameter (μm), and the horizontal axis represents the position in the longitudinal direction of the guide wire 1. Fig.12 From the chart, we can see that Figure 8 Compared with the guide wires shown, the surface of the guide wire 1C of the comparative example has no irregularities and is smooth.

[0092] Fig.13 Yes Fig.12 The waveform diagram of the measurement data shown is the result of FFT analysis. The vertical axis represents the power value, and the horizontal axis represents the spatial frequency (1 / mm). Fig.13 As can be seen from the waveform diagram, there are substantially no irregularities on the surface of the guide wire 1C as a comparative example.

[0093] Fig.14 Table T2 shows the results of FFT analysis of the outer diameter of the guide wire 1C of the comparative example.

[0094] As shown in the first row (1) of Table T1, in the guide wire 1C of the comparative example, the MPF 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. In addition, the deviation between the MPF value and the MDF value is caused by Fig.13 The power value has a variation of a degree not shown in the figure. This variation is caused by the variation of the diameter caused by the processing of the core material 11 of the guide wire.

[0095] The third row (3) to the seventh row (7) of Table T2 show the data distribution when the range of spatial frequency relative to MPF is changed. As shown in the third row (3), the cumulative value in the entire spatial frequency range is 1.51776. As shown in the fourth row (4), in the range of spatial frequency of positive and negative 4 of MPF, the cumulative value becomes 0.926171. Its distribution ratio is 61%. As shown in the fifth row (5), in the range of spatial frequency of positive and negative 3 of MPF, the cumulative value becomes 0.861739. Its distribution ratio is 57%. As shown in the sixth row (6), in the range of spatial frequency of positive and negative 2 of MPF, the cumulative value is 0.801288. Its distribution ratio is 53%. As shown in the seventh row (7), in the range of spatial frequency of positive and negative 1 of MPF, the cumulative value is 0.612517. Its distribution ratio is 40%.

[0096] As shown in the eighth row (8) of Table T2, in the range of spatial frequency from 3 to 10 (1 / mm), the cumulative value is 0.357573, and its distribution ratio is 24%.

[0097] Fig.151C is a table showing the results of measuring the outer diameter of the guide wire 1C. The unit is μm. The maximum value of the outer diameter is 561.7, the minimum value of the outer diameter is 559, the median value of the outer diameter is 560.35, the average value of the outer diameter is 560.1724, and the variation value of the outer diameter is 0.662483. Although detailed description is omitted, the surface of the guide wire 1C of the comparative example does not have the concave portion 13 of the present embodiment and is substantially smooth, so there is almost no variation in the outer diameter.

[0098] use Fig.16 , a case where the guide wire 1 has a tapered portion will be described. Fig.16 This is a table showing the results of measuring the outer diameter dimension of the tapered portion of the guide wire 1 .

[0099] Although not shown in the figure, the guide wire 1 sometimes has a tapered portion that gradually decreases in diameter toward the front end side. In the tapered portion of the guide wire 1, a taper is formed in the core material 11, and a recess 13 is formed on the surface of the guide wire 1, so the change in the outer dimensions of the tapered portion is greater than the change in the outer dimensions of the non-tapered portion. Therefore, in order to find the change in the outer dimensions caused by the formation of the recess 13 in the tapered portion, it is necessary to find the value of the corrected outer dimensions change so as to offset the change in the diameter of the core material 11.

[0100] The correction of the change in external dimensions is performed as follows: the change in the outer diameter of the core material 11 between the front end and the base end of the tapered portion is approximated by a linear function, and the inverse function of the linear function is used to add or subtract the outer diameter value according to the distance from the front end or base end of the tapered portion.

[0101] exist Fig.16 The upper side shows the analysis value of the measurement data when the concave portion 13 is irregularly formed on the core material 11 of the guide wire 1 in the tapered portion with a reduced diameter of 8 μm every 10 cm in the longitudinal direction. Fig.16 The lower side shows the analysis value of the measurement data when the concave portion 13 is not formed in the tapered portion where the diameter of the core material 11 of the guide wire 1C decreases by 8 μm every 10 cm in the longitudinal direction. The unit is μm.

[0102] The upper side of the table is explained. The maximum value of the outer diameter is 570.205, the minimum value of the outer diameter is 550.655, the median value of the outer diameter is 560.43, the average value of the outer diameter is 563.6368, and the variation value of the outer diameter is 3.269153.

[0103] If we focus on the change in the outer diameter, the maximum value of the outer diameter change relative to the minimum value of the outer diameter is 19, the minimum value of the outer diameter change is 0, and the outer diameter change rate is 3.55%. The outer diameter change value relative to the average value of the outer diameter is +6.363237 to -12.6368, and the outer diameter change rate is +1.13% to -2.24%. The outer diameter change value relative to the median value of the outer diameter is +9.57 to -9.43, and the outer diameter change rate is +1.71% to -1.68%.

[0104] Therefore, compared with a case where there is no taper, the outer dimension variation at the tapered portion becomes larger, and therefore it is necessary to correct the outer dimension at the tapered portion.

[0105] right Figure 17 to Figure 22 Provide explanation. Fig.17 This is an analysis result table T3 regarding another case where irregular recessed portions 13 are formed on the surface of the guide wire 1 . Fig.18 This is a chart showing measured external dimensions. Fig.19 This is a graph showing the FFT analysis results of the external dimension measurement data. Fig. 20 This is an analysis result table T4 regarding still another case where irregular recessed portions 13 are formed on the surface of the guide wire 1 . Fig.21 This is a chart showing measured external dimensions. Fig. 22 The table T3 and the table T4 are graphs showing the FFT analysis results of the external dimension measurement data. Figure 8 to Figure 10 The parsing results of Table T1 are thicker examples.

[0106] As shown in the first row (1) of Tables T1, T3, and T4, in the guide wire 1 having the recess 13, the MPF is in the range of 4 to 7, and the MDF is also in the range of 4 to 7. As shown in the second row (2), there are at least 100 data with power values ​​greater than 0.01.

[0107] As described in the third row (3) to the seventh row (7) of Tables T1, T3, and T4, the lower limit of the distribution ratio of positive and negative spatial frequencies 4 is 66%. The upper limit of the distribution ratio of positive and negative spatial frequencies 1 is 35%. The lower limit of the distribution ratio of positive and negative spatial frequencies 4 is set to the central value between the minimum value (70% of T4) of the fourth row (4) of Tables T1, T3, and T4 forming concave and convex and the value (61%) of the fourth row (4) of Table T2 without concave and convex. The upper limit of the distribution ratio of positive and negative spatial frequencies 1 is set to the central value between the maximum value (31% of T3) of the seventh row (7) of Tables T1, T3, and T4 forming concave and convex and the value (40%) of the seventh row (7) of Table T2 without concave and convex. The lower limit of the difference in ratio between the lower limit of the distribution ratio of positive and negative spatial frequencies 4 in the table with concave and convex and the upper limit of the distribution ratio of positive and negative spatial frequencies 1 is 31%.

[0108] As shown in the eighth row (8) of Tables T1, T3, and T4, it can be seen that the irregular recessed portions 13 of this embodiment are formed on the surface of the catheter 1 in the range of spatial frequency of 3 to 10 (1 / mm).

[0109] Fig.23 This is a graph comparing the sliding resistance of the guide wire 1 of this embodiment having the concave portion 13 on the surface and the sliding resistance of the guide wire 1C of the comparative example having no concave portion on the surface. The vertical axis represents the sliding resistance value. Fig.23 In the simulation environment, an endoscope is inserted from the oral cavity through the esophagus and stomach into the duodenum, and a guide wire is inserted into the endoscope. In this simulation environment, guidewire 1 and guidewire 1C are compared by simulating the initial situation of the endoscope being inserted into the body, where the guidewire is introduced into an environment filled with physiological saline in the guidewire insertion lumen of the endoscope, and the situation of the guidewire being introduced into an environment where bile flows back from the front end of the endoscope and fills the guidewire insertion lumen after the guidewire is inserted into the endoscope. The bar chart in the oblique line portion represents the guidewire 1 of the present embodiment, and the blank bar chart represents the guidewire 1C of the comparative example. In any simulation experiment, it can be seen that the guidewire 1 of the present embodiment having irregular recesses 13 on the surface has a small sliding resistance.

[0110] According to the present embodiment thus constituted, the sliding resistance can be reduced by irregularly arranging the recesses 13 on the substantially flat surface 121 of the outer layer 13. In particular, the shape of the recesses includes a spatial frequency of 3 to 10 (1 / mm), which can reduce the sliding resistance.

[0111] From the first row (1) of Tables T1 and T3, it can be seen that when the value of at least one of MDF or MPF is 4 to 7 (1 / mm), the sliding resistance is reduced. Similarly, from the first row (1) of Tables T1 and T3, it can be seen that when the value of at least one of MDF or MPF is 5 (1 / mm) or more, the sliding resistance is reduced.

[0112] From the second row (2) of Tables T1 and T3, it can be seen that the sliding resistance is reduced when there are at least 10 spatial frequencies with power values ​​of 0.01 or more.

[0113] from Fig. 9 From the FFT waveform graph of , it can be seen that the sliding resistance is reduced when the spatial frequency with a power value of 0.01 or more is dispersed at 1 to 10 (1 / mm).

[0114] From the seventh row (7) of Tables T1 and T3, it can be seen that the sliding resistance decreases when the distribution ratio of the average frequency component value in the range of plus or minus 1 (1 / mm) is less than 35%.

[0115] From the fourth row (4) of Tables T1 and T3, it can be seen that the sliding resistance is reduced when the distribution ratio of the average frequency component value in the range of plus or minus 4 (1 / mm) is approximately 80% or more.

[0116] From the ratio difference in the seventh row (7) of Tables T1 and T3, it can be seen that the sliding resistance decreases 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 about 50% or more.

[0117] From the eighth row (8) of Table T1, it can be seen that the sliding resistance is reduced when the power spectrum of the spatial frequency 3 to 10 (1 / mm) is 50% or more. Similarly, from the eighth row (8) of Table T1, it can be seen that the sliding resistance is reduced when the power spectrum of the spatial frequency 3 to 10 (1 / mm) is 70% or more.

[0118] from Fig.11 It can be seen from the outer diameter variation rate that the sliding resistance decreases when the outer diameter variation rate relative to the minimum outer diameter value is 3% or more.

[0119] from Figure 8 , Fig.18 , Fig. 22 As can be seen from the graph, the sliding resistance is reduced when there are 10 or more locations with an outer diameter change of less than 1 mm in width and 5 μm or more in a range of 1 cm in the long axis direction.

[0120] From Fig.16From the measurement results of the case where the concave portion 13 is formed in the tapered portion shown on the upper side, it can be seen that when the outer layer portion 12 includes a tapered portion, if the outer diameter change rate excluding the outer diameter change caused by the tapered portion is greater than 3% relative to the minimum outer diameter value, the sliding resistance is reduced.

[0121] As mentioned above, although embodiment of this disclosure was described, this disclosure is not limited to these embodiments, Various deformation|transformation is possible.

[0122] The above-mentioned embodiments are described in detail for the purpose of making the description of the present invention clear and are not necessarily limited to all the structures described. In addition, a part of the structure of a certain embodiment can be replaced with the structure of other embodiments. In addition, the structure of other embodiments can be added to the structure of a certain embodiment. In addition, other structures can be added, deleted, or replaced with a part of the structure of each embodiment.

[0123] In addition, the technical features included in the above-mentioned embodiments are not limited to the combinations explicitly indicated in the scope of the claims, and can be appropriately combined.

[0124] Explanation of symbols

[0125] 1—guide wire, 1C—guide wire as a comparative example, 2—catheter, 11—base material portion, 12—outer layer portion, 13—concave portion, 130—crack.

Claims

1. A long medical device, characterized in that: have: Base material department; as well as an outer layer portion made of resin provided on the surface of the base portion, The substantially flat surface of the outer layer portion has irregularly arranged recessed portions, and the recessed portions are formed by cracks generated by drying of a resin suspension as a material of the outer layer portion.

2. The long medical device according to claim 1, characterized in that: The substantially flat surface is a surface corresponding to a region where no coil is arranged on the lower side of the outer layer portion.

3. The long medical device according to claim 1, characterized in that: The shape of the recessed portion is a linear portion of an irregular shape.

4. The long medical device according to claim 3, characterized in that: The shape of the waveform representing the outer diameter having the concave or convex portion includes a spatial frequency of 3 to 10 (1 / mm).

5. A long medical device, characterized in that: have: Base material department; as well as an outer layer portion made of resin provided on the surface of the base portion, The substantially flat surface of the outer layer portion has irregularly arranged recessed portions, the recessed portions being formed by cracks generated by drying of a resin suspension as a material of the outer layer portion. When the measurement result of the outer diameter dimension of the outer layer portion along the long axis direction is subjected to FET, that is, fast Fourier transform analysis, at least one of the following conditions 1 to 9 is satisfied: Condition 1: At least one of the value of the central power frequency (MDF) or the mean frequency (MPF) is 4 to 7 (1 / mm); Condition 2: At least one of the values ​​of MDF or MPF is 5 (1 / mm) or more; Condition 3: There are at least 100 spatial frequencies with power values ​​greater than 0.01; Condition 4: The spatial frequencies with power values ​​of 0.01 or more are dispersed in the range of 1 to 10 (1 / mm); Condition 5: The distribution ratio of the range of the average frequency component value of plus or minus 1 (1 / mm) is less than 35%; Condition 6: The distribution ratio of the average frequency component value within the range of plus or minus 4 (1 / mm) is 70% or more; Condition 7: The difference between the distribution ratio of the average frequency component value of plus or minus 1 (1 / mm) and the distribution ratio of the average frequency component value of plus or minus 4 (1 / mm) is 40% or more; Condition 8: The power spectrum of spatial frequency 3 to 10 (1 / mm) is more than 50%; Condition 9: The power spectrum of the spatial frequency 3 to 10 (1 / mm) is 65% or more.

6. A long medical device, characterized in that: have: Base material department; as well as an outer layer portion made of resin provided on the surface of the base portion, The substantially flat surface of the outer layer portion has irregularly arranged recessed portions, the recessed portions being formed by cracks generated by drying of a resin suspension as a material of the outer layer portion. The measurement result of the outer diameter dimension of the outer layer portion along the long axis direction satisfies at least one of the following conditions 10 and 11: Condition 10: The outer diameter variation rate relative to the minimum outer diameter value is 3% or more; Condition 11: Within a range of 1 cm in the long-axis direction, there are 10 or more locations where the outer diameter changes with a width of less than 1 mm and 5 μm or more.

7. The long medical device according to claim 6, characterized in that: In the above condition 10, when the outer layer portion includes a tapered portion, the outer diameter variation rate excluding the outer diameter variation due to the tapered portion is 3% or more with respect to the minimum outer diameter value.

8. The long medical device according to any one of claims 1 to 7, characterized in that: The outer layer is any one of perfluoroalkoxyalkane (PFA), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), and tetrafluoroethylene-ethylene copolymer (ETFE).

9. The long medical device according to any one of claims 1 to 7, characterized in that: The above-mentioned long medical device is a guide wire.

10. The long medical device according to claim 9, characterized in that: The outer diameter of the guide wire is 1 mm or less.

11. The long medical device according to claim 9, characterized in that: The outer diameter of the guide wire is 700 μm or less.

12. The long medical device according to claim 9, characterized in that: The average value of the outer diameter of the guide wire is 500 to 600 μm.

13. The long medical device according to any one of claims 1 to 7, characterized in that: The above-mentioned long medical device is a catheter.

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