JP5367503B2 - Medical guide wire, manufacturing method thereof, and assembly of medical guide wire and microcatheter, or balloon catheter and guiding catheter - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a manufacturing method or the like which is a technical subject as a suitable condition for improving the tensile strength characteristics of a core wire by paying attention to the temperature and tensile strength characteristics of the core wire to which high deformation wire drawing is executed, in a medical guide wire using a stainless steel wire for the core wire. <P>SOLUTION: By using an austenitic stainless steel wire to which solid solution treatment is executed for the core wire, performing the wire drawing work of strong deformation with the total area reduction rate of 90% to 97.6%, and repeatedly using low temperature heat treatment of a suitable condition for each mechanical work of the core wire, and by taking into consideration the low temperature heat treatment after twisting work, the heat utilization of resin film formation to the core wire and the heat conductivity of the core wire, etc., the mechanical strength characteristics of the core wire are improved. <P>COPYRIGHT: (C)2011,JPO&amp;INPIT

Description

  The present invention relates to a medical guide wire in which the mechanical strength characteristics of the core wire are improved by subjecting the core wire made of stainless steel wire to mechanical processing, followed by low-temperature heat treatment in a certain temperature range, and a manufacturing method thereof.

  Since a medical guide wire inserted into a blood vessel is a thin wire, it must satisfy the safety of the human body in consideration of mechanical strength characteristics, and various proposals have been made for this purpose.

  Patent Document 1 describes a predetermined degree of processing and low-temperature heat treatment conditions using high silicon stainless steel (Si: 3.0% to 5%), and aims to improve the tensile strength characteristics of the core wire.

  Patent Document 2 describes predetermined processing conditions using an elastic shape memory alloy and aims to improve quality.

  Patent Document 3 describes a different twisting process and a different heat treatment for each zone divided using a thin metal wire, and aims to improve quality.

JP 2003-342696 A JP 2000-512691 A JP 2005-14040 A

In the conventional guide wire, an austenitic stainless steel wire that is generally used as the core wire material is used. However, in order to satisfy the characteristics as a medical guide wire, the core wire is subjected to mechanical processing in advance. When performing high-strength, high-strength wire drawing, and then mechanically processing the core wire, pay attention to the tensile strength characteristics due to the heat effect of this strongly processed core wire. In addition, in the correlation between the mechanical processing of the core wire and the low-temperature heat treatment, by accumulating the steps having the effect of improving the tensile strength property of the core wire, the medical guide wire comprising the core wire having a high tensile strength property, and the manufacturing method thereof There is no technical idea about.
The object of the present invention is to correlate the tensile strength characteristics due to the heat effect on the core wire, which is strongly processed using an austenitic stainless steel wire as the core wire, and the mechanical processing applied to the core wire in order to satisfy the characteristics as a medical guide wire. It is an object of the present invention to provide a medical guide wire that can obtain the most preferable tensile strength characteristic of a core wire and can be safely operated by an operator.

According to the first aspect of the present invention, a core wire made of a flexible elongated body, a coil spring body having a core wire inserted through the tip end portion of the core wire, and a joining member are used at the tip end portions of the core wire and the coil spring body. In a medical guide wire having a lead plug formed therein, an austenitic stainless steel wire whose core wire is subjected to a solid solution treatment is used, and a low temperature heat treatment step of 400 ° C. to 495 ° C. is provided after the wire drawing step. The process and low temperature heat treatment process are set as one set, and after each process is repeated at least one set, the final wire drawing process is provided, and the total area reduction until the final wire drawing process is changed from 90% to 97.6%. The total increase rate of tensile fracture strength due to low-temperature heat treatment until the process is 8% or more. After the final wire drawing process, low-temperature heat treatment at 380 ° C to 495 ° C and mechanical processing such as grinding or pressing at the tip of the core wire After that, at least the mechanically processed portion is subjected to low-temperature heat treatment at 180 ° C. to 420 ° C. (heat utilization temperature range at the time of resin film molding described later), and the rate of increase in tensile fracture strength by each low-temperature heat treatment after the final wire drawing step The total is 2% or more, and the total increase rate of the tensile fracture strength by each low-temperature heat treatment is 10% or more.
With this configuration, paying attention to the correlation between low temperature heat treatment and tensile strength characteristics after wire drawing of strong processing, and low temperature heat treatment and tensile strength characteristics after mechanical processing, the effect of improving tensile strength characteristics for each process By accumulating the steps, it is possible to provide a medical guide wire composed of a core wire having a high tensile strength characteristic.

The invention according to claim 2 is the same as the invention according to claim 1, wherein after the final wire drawing step, a predetermined amount of twisting is performed on the core wire, and then the core wire is subjected to low-temperature heat treatment by electric resistance heating, and then the tip of the core wire After undergoing a grinding process or a pressing process, which is a mechanical process, the outer peripheral part of the core wire is subjected to a low-temperature heat treatment controlled to a certain temperature range using heat heated during resin film molding. .
With this configuration, the degree of processing of the core wire is further improved by twist processing using a strong core wire and subsequent low-temperature heat treatment by electric resistance heating, and by low-temperature heat treatment controlled to a certain temperature range by mechanical processing, Residual stress due to each mechanical processing is removed to improve tensile strength characteristics, and the total increase rate can be improved by 10% or more. The invention described in claim 3 is the same as the invention described in claim 2 except that after the core wire tip is mechanically processed, the outer peripheral portion of the core wire is subjected to low-temperature heat treatment controlled to a certain temperature range before the resin film is formed. The total increase rate of the tensile breaking strength can be improved by 11.5% or more by this configuration.

  The invention according to claim 4 uses the core wire according to any one of claims 1 to 3 to perform a pressing process after the low-temperature heat treatment of the core wire tip grinding part, and at least the core part is subjected to the pressing process. Using the heat at the time of resin film molding on the outer periphery of the coil spring body attached to the tip, low-temperature heat treatment controlled to a certain temperature range can be performed, and the tensile strength characteristics of the pressed portion can be improved.

The invention according to claim 5 significantly improves the tensile breaking strength of the core wire by setting the total area reduction rate from 94% to 97.6% as compared with the invention according to any one of claims 1 to 4. Can do.
With this configuration, the rate of increase in tensile rupture strength is different between the heat treated without twisting the core wire in particular, and the rate of increase in tensile rupture strength differs from the total area reduction rate of 94%, A medical guide wire composed of a core wire having a high tensile strength characteristic can be obtained by increasing the rapid tensile strength at break.

In the invention described in claim 6, a core wire made of a flexible elongated body, a coil spring body having a core wire inserted through the tip end portion of the core wire, and a joining member are used at the tip end portions of the core wire and the coil spring body. In a medical guide wire having a lead plug, a low temperature heat treatment process at 400 to 495 ° C. for 10 minutes to 180 minutes after the wire drawing process and the wire drawing process using an austenitic stainless steel wire whose core wire is solid solution treated The wire drawing step and the low-temperature heat treatment step are set as one set, and after at least one set is repeated, the final wire drawing step is provided, and the total area reduction until the final wire drawing step is 90% to 97.6. %, And with one end of the core wire subjected to a load of 5 to 30% of the tensile breaking force of the core wire before twisting, the other end is subjected to a twisting process of 100 to 250 times / m. After that, power A low temperature heat treatment step at 380 ° C. to 495 ° C. for 30 seconds to 60 minutes by resistance heating, a step of grinding the core wire tip or pressing after the grinding, and a coil spring body by inserting the core wire into the tip of the core wire , A step of partially bonding the core wire and the coil spring body using the bonding member, and a step of forming a leading plug in which the core wire and the end of the coil spring body are bonded using the bonding member It is a manufacturing method of the medical guide wire characterized by comprising.
With this configuration, the low-temperature heat treatment after wire-stretching and low-temperature heat treatment by electrical resistance heating after strong-working twisting improves the degree of processing of the core wire and removes residual stress in each strong-working process. And the manufacturing method of the medical guide wire which consists of a core wire with a high tensile strength characteristic can be provided.

  The invention described in claim 7 is the same as that described in claim 6 except that a low temperature heat treatment is performed by electrical resistance heating after a strong twisting process, and thereafter electrical resistance heating in a certain temperature range (400 ° C. to 495 ° C.) is performed. By providing a low-temperature heat treatment step such as atmospheric heating using a heat treatment furnace or the like, the invention according to claim 8 is a resin film molding of the core wire after grinding the tip end portion of the core wire with respect to the invention according to claim 6. In the method of manufacturing a medical guide wire composed of a core wire having high tensile strength characteristics as described above, by providing a low temperature heat treatment process controlled to a certain temperature range (340 ° C. to 420 ° C.) and time on the core wire using the heat of time is there.

  The invention according to claim 9 is the invention according to any one of claims 6 to 8, wherein the twisting process of the twist of the other end of the core wire is 100 times / m to 200 times / m. It is characterized by that. With this configuration, the inhomogeneity between the surface layer portion and the inner layer portion of the core wire is reduced and homogenized, the residual angle after bending deformation is reduced, the linearity is improved, and the medical wire comprising a core wire with stable quality A method for manufacturing a guide wire can be provided.

  The invention according to claim 10 is the resin according to any one of claims 6 to 9, wherein the core wire and the coil spring body are joined using the joining member, and then the resin of the outer peripheral portion of the coil spring body. By using the heat at the time of film forming, at least the core wire in the coil spring body is provided with a low temperature heat treatment process controlled at a certain temperature range (180 ° C. to 300 ° C.) and time, and thus it is composed of a core wire having high tensile strength characteristics as described above. It is a manufacturing method of a medical guide wire.

  The invention according to claim 11 is a plurality of the inventions according to any one of claims 6 to 10, wherein the core wire drawing step has a predetermined area reduction ratio from primary drawing to final drawing. This is a method for producing a medical guide wire composed of a core wire having high tensile strength characteristics that can be produced with high productivity and stable quality by forming a die arrangement using dies.

  The invention according to claim 12 is the medical guidewire according to any one of claims 1 to 5, wherein the joining member is made of a eutectic alloy having a melting temperature of 180 ° C to 495 ° C. It is a manufacturing method of the medical guide wire in any one of Claims 6-11 which consists of a joining member. With this configuration, when the core wire and the coil spring body are joined using the joining member, the tensile strength of the core wire is utilized by utilizing the heat of fusion of the joining member without decreasing the tensile breaking strength of the core wire due to heat during joining. Breaking strength characteristics can be improved, and joining that improves the tensile breaking strength of the core wire at the joint portion between the core wire and the intermediate joining member or the rear end joining member and the joint portion between the core wire and the leading plug can be made possible. .

  According to a fourteenth aspect of the present invention, in the assembly of the medical guidewire, the microcatheter and the guiding catheter according to any one of the first to fifth and twelfth aspects, the outer diameter of the medical guidewire is 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) medical guide wire inserted into a microcatheter having an inner diameter of 0.28 mm to 0.90 mm and an inner diameter of 1.59 mm A medical guide wire, a microcatheter, and a guiding catheter assembly, wherein a medical guide wire and a micro catheter are inserted into a 2.00 mm guiding catheter. With this configuration, an assembly with a reduced diameter can be obtained.

  According to a fifteenth aspect of the present invention, in the assembly of the medical guidewire, the balloon catheter, and the guiding catheter according to any one of the first to fifth and twelfth aspects, the outer diameter of the medical guidewire is 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) medical guide wire inserted into a balloon catheter having an inner diameter of 0.28 mm to 0.90 mm and an inner diameter of 1.59 mm A medical guide wire, balloon catheter, and guiding catheter assembly, wherein a medical guide wire and a balloon catheter are inserted into a 2.00 mm guiding catheter. With this configuration, an assembly with a reduced diameter can be obtained.

It is the front view of a medical guide wire and a core wire, and the principal part enlarged view of a core wire. It is a low-temperature heat treatment and tensile strength characteristic view. (Examples 1 and 2) It is a low-temperature heat treatment and tensile strength characteristic view. (Examples 6, 7, and 8) It is a low-temperature heat treatment and tensile strength characteristic view. (Examples 1, 2, 6, 7, 8) It is a twist frequency and tensile strength characteristic figure with and without low-temperature heat treatment. It is a characteristic view of the number of twists with and without low-temperature heat treatment and the bending residual angle. It is embodiment of the continuous twist manufacturing method by electrical resistance heating. It is a temperature and tensile strength characteristic view. It is a total area reduction rate and tensile strength characteristic figure. It is the front view of the other Example of a medical guide wire, and a side view.

  The best embodiment of the present invention will be described with reference to the drawings.

  FIG. 1 shows a medical guide wire 1 according to an embodiment. A distal end portion 21 of a core wire 2 has a coil spring body (hereinafter referred to as a coil body) 3 that is coaxially fitted on the distal end side of the coil body 3. Consists of a radiopaque material coil 31 such as gold, platinum, tungsten or the like, and the core wire 2 is connected to the front end portion 21 of the core wire 2 by an intermediate front side joining member 41, an intermediate rear side joining member 42, and a rear end joining member 43. The coil body 3 is partially joined to each other by using the joining member 4, and a rounded cylindrical lead plug 5 is formed at the tip end portion of the core wire 2 by the joining member 4. And are joined.

The core wire 2 is a thin wire having a diameter of approximately 0.060 mm to 0.200 mm, approximately 300 mm from the tip of the tip portion 21, and the remaining proximal portion 22 is formed of a thick wire having a diameter of approximately 1200 mm to approximately 2700 mm. Yes. The small-diameter portion of the distal end portion 21 gradually changes in diameter toward the distal end, and the cross-sectional shape thereof may be either a circular cross section or a rectangular cross section. In addition, a resin coating 6 such as a fluororesin or a urethane resin is formed on the outer peripheral portion of the core wire 2 on the proximal side 22, and particularly on the outer peripheral portion of the coil body 3 on the proximal side 22 of the core wire 2. A fluororesin (PTFE) is formed into a film.
And the outer peripheral part is formed with a hydrophilic film 7 such as polyvinyl pyrrolidone which exhibits lubricating properties when wet, and the tip part 21 of the core wire 2 is hermetically covered with the resin film or the like.

And the core wire 2 is characterized by performing wire drawing with a total area reduction of 90% to 97.6% using a solution-treated austenitic stainless steel wire. Here, the total area reduction ratio means a reduction ratio indicating a difference in cross-sectional area between the wire diameter of the solid solution processed wire and the final finished wire diameter in the wire drawing process. .
The reason why the total area reduction is 90% or more is that the tensile fracture strength increases at 80% and the steep slope increases at 90% or more. (FIG. 9) This is considered to be due to the development of this structure as it becomes a fibrous structure as the degree of processing increases due to the strong wire drawing of 90% or more. The reason why the total area reduction is 97.6% or less is that when the degree of processing exceeds this, voids begin to form in the structure and become brittle, which is considered the limit of wire drawing.

  The reason why “Solution-treated austenitic stainless steel wire was drawn” was to obtain an austenitic structure with good workability, and the austenitic stainless steel wire was refined by heat treatment using transformation points. This is because the crystal grains can be refined only by cold working, and the tensile strength characteristics can be improved by exhibiting remarkable work hardenability by wire drawing. The reason for using austenitic stainless steel wire is that martensitic stainless steel wire exhibits quench hardenability by heat treatment and is easily affected by heat, and ferritic stainless steel wire is temperature brittle (sigma brittle, 475 ° C brittle) Because there is a problem.

Table 1 shows a temperature range of 400 ° C. to 495 after primary wire drawing using a wire diameter of 1.5 mm of a wire rod (base material) having a tensile breaking strength of 68 kgf / mm ² of a solution treated austenitic stainless steel wire. First low-temperature heat treatment (at 420 ° C. for 75 minutes in this example) by atmospheric heating in a furnace using a heat treatment furnace at 10 ° C. to 180 minutes, followed by secondary wire drawing (final wire drawing in this example) In a furnace using a heat treatment furnace with a total area reduction rate of 90% (Example 1) and 94% (Example 2), and thereafter in the same temperature range from 400 ° C. to 495 ° C. for 10 minutes to 180 minutes. A secondary low-temperature heat treatment (at 450 ° C. for 120 minutes in this embodiment) is performed by heating in the atmosphere, and the tip portion 21 of the core wire 2 is ground to an outer diameter of 0.150 mm. Such as PTFE by spraying Heating in an atmosphere for drying / firing after forming a coating film of fluororesin, taking into consideration the tensile strength characteristics depending on the temperature of the core wire 2, a third low-temperature heat treatment in the temperature range of 340 ° C to 420 ° C for 10 minutes to 180 minutes (this In the examples, 385 ° C., 30 minutes) was added. FIG. 2 is a graph of Table 1. Here, the tensile breaking strength means a value obtained by dividing a value obtained by applying a tensile force to the core wire and dividing the value by the cross-sectional area of the core wire.

In the following, the circled numbers in each table are shown in parentheses in the text.
According to Table 1, the rate of increase in tensile rupture strength by low temperature heat treatment (primary low temperature heat treatment in this example) before final wire drawing (secondary wire drawing in this example) is 12.6% in Example 1, In Example 2, it was 13.3%, and the total increase (2) + (3) in tensile fracture strength after each low-temperature heat treatment after the final wire drawing was 2.8% in Examples 1 and 2, respectively. The total increase rate (1) + (2) + (3) of the tensile breaking strength of each low-temperature heat treatment including the wire drawing step was 4.0% in Examples 1 and 2, respectively. , 17.3%. In particular, when the tensile strength at break of the core wire having a mechanically machined outer diameter of 0.150 mm is converted into a cross-sectional area, 4,522 gf is 4,575 gf in Example 1 and about 53 gf compared to before grinding. Similarly, in Example 2, it increases by about 71 gf.
Since the tip of the ground core 2 is processed by invading the bending meandering lesion in the coronary artery, the tensile strength and the repeated bending / bending fatigue resistance are required. Since it can be expressed by a function of stress (SN diagram), the number of repeated endurance increases dramatically even with a slight increase rate of this part.

And supplementally, the reason why the temperature range of the low-temperature heat treatment after the primary wire drawing is from 400 ° C. to 495 ° C. from 10 minutes to 180 minutes is that the tensile strength characteristics depending on the temperature at the high-work drawing of austenitic stainless steel wire described later (FIG. 8) and the stability in the high-strength wire drawing process and the stability of the quality are taken into consideration, and the temperature range of the secondary low-temperature heat treatment after the final wire drawing process is 400 ° C to 495 ° C from 10 minutes to 180 minutes. In consideration of the tensile strength characteristics with temperature (Fig. 8) in the high-strength wire drawing of austenitic stainless steel wire, productivity by atmospheric heating using a heat treatment furnace, and quality stability, as described above. The reason why the temperature range of the third low-temperature heat treatment after grinding is 10 minutes to 180 minutes at 340 ° C. to 420 ° C. is that the fluororesin (PTFE) that forms a resin film on at least the hand portion 22 of the core wire 2 is dried. - improvement and productivity in temperature due to the tensile strength properties of the strong working drawing austenitic stainless steel wire by the heating temperature for the calcination (FIG. 8), and is because in consideration of the stability of quality. In addition, although a wire drawing process and a low-temperature heat treatment process are made into 1 set and 5 sets or more may be repeated, 3 sets or less are desirable from viewpoints of economy, productivity, etc.
In addition, the area reduction rate in each step of the primary wire drawing process and the secondary wire drawing process may be set high, but the area reduction rate in the primary wire drawing process is set high before the primary low temperature heat treatment (this (In the example, 87.5% to 94.2%) By increasing the amount of work-induced martensite, crystal grain growth due to heat treatment can be suppressed, and the crystal grain size can be reduced. Moreover, it is desirable to set the area reduction rate in the primary wire drawing process high from the viewpoints of economy and productivity, and to set the subsequent wire drawing process lower than that. In addition, in order to further enhance the effect of improving the tensile fracture strength due to the formation of work-induced martensite, the processing temperature, which is the core wire surface temperature at the time of wire drawing, is desirably 140 ° C. or less, and the setting of the cooling liquid in wet wire drawing or wire drawing This can be achieved by setting the lubricant to be sprayed on the die at the time and setting these temperatures.

  Next, Table 2 shows that the total area reduction is 94.8% (Example 3), 96% (Example 4), and 97.6% (Example 5) with respect to Examples 1 and 2 above. After the final wire drawing process (secondary wire drawing in this embodiment), the wire 2 is twisted under a certain condition and then energized in the state after the twist, and 380 ° C. by electric resistance heating. A low-temperature heat treatment is performed for 30 seconds to 60 minutes (450 ° C., 5 minutes in this embodiment) in a temperature range of ˜495 ° C. (about 1.8 amperes), and a machine such as a grinding process is applied to the tip 21 of the core wire 2 as described above. Then, in the same manner as the third low-temperature heat treatment, a low-temperature heat treatment step (at 385 ° C. for 30 minutes in this embodiment) is performed by atmospheric heating using a heat treatment furnace at a temperature range of 340 ° C. to 420 ° C. for 10 minutes to 180 minutes. ) Shows the later tensile strength characteristics. The low-temperature heat treatment other than the above is the same as in Examples 1 and 2. In addition, the twisting of the core wire is performed by adding a load (weight 12) described later, and the load is 10% to 30% of the tensile breaking force of the core wire before the twisting (this implementation) 20% in the example), and the same applies to Examples 6-8 and 11-13.

  According to Table 2, the rate of increase in tensile fracture strength by the primary low-temperature heat treatment before the final wire drawing (secondary wire drawing in this example) is 12.5% and 13.3 in Examples 3, 4 and 5, respectively. %, 12.6%, and the total increase rate (2) + (3) of the tensile fracture strength of each low-temperature heat treatment after the final wire drawing was 5.1%, 7 for Examples 3, 4 and 5, respectively. The total increase rate (1) + (2) + (3) of the tensile breaking strength of each low-temperature heat treatment including the wire drawing step is 0.9% and 7.6% in Examples 3, 4, and 5. These are 17.6%, 21.2%, and 20.2%, respectively. In particular, when the core wire is subjected to low-temperature heat treatment by electric resistance heating in the state after the twisting process, the rate of increase in the tensile strength at break tends to be higher than those in Examples 1 and 2. (Figure 3)

The reason for this is that the austenitic stainless steel wire used for the core wire 2 has increased mechanical strength as the degree of work increases, and in particular, a core wire that has been drawn with a total area reduction of 90% to 97.6%. Has a high degree of processing, and further performs twisting in a cold state, thereby further increasing the mechanical strength by further promoting the refinement of crystal grains than in the hot state, and twisting. After processing, it is better to energize the core wire with the load applied at the time of twisting, perform low-temperature heat treatment by electric resistance heating, remove residual stress due to processing, and average locally generated stress. This is because the core wire 2 having a high tensile breaking strength can be obtained. In particular, there is a sharp increase in tensile strength at the boundary of the total area reduction rate near 94%. (Fig. 4)
In addition, grinding of the core wire 2 can be facilitated, and productivity can be improved. The reason for this is that when twisting is performed in a hot state under low-temperature heat treatment after reaching a certain temperature, the crystal grains tend to become coarse due to heating, and the core wire material tends to become viscous. It is difficult to increase the mechanical strength by twisting the crystal grains. In addition, due to heat generation by twisting and heating by energization, it becomes difficult to control the core wire substantially in temperature (current, etc.), the core wire in an overheated state has a low tensile breaking strength, and a core wire having a viscosity is easily generated. In addition, the residual angle after bending deformation, which will be described later, becomes large, and further, waviness occurs when grinding the outer periphery of the core wire using a centerless grinding machine etc. due to the viscosity of the core wire, making the grinding process difficult and producing It is extremely difficult to always obtain stable quality.
For these reasons, it is possible to obtain a core wire having higher tensile fracture strength by applying a low temperature heat treatment by energizing the core wire in a state where a predetermined load is applied at the time of twisting after a predetermined amount of twisting processing. It is desirable.

  And, supplementally, the temperature range of 380 ° C. to 495 ° C. was set as the low temperature heat treatment condition for electric resistance heating. The tensile strength characteristics of the temperature due to the strong work drawing of the austenitic stainless steel wire described later (FIG. 8) This is because the bending deformation residual angle (FIG. 6) after the bending test of the twisted core wire 2 described later was taken into consideration. The reason for setting the low temperature heating time within 30 to 60 minutes is that the tensile strength is below 30 seconds. This is because the characteristic improvement effect is small, and if it exceeds 60 minutes, a constant value is obtained, or a significant improvement effect cannot be obtained.

  Next, Table 3 shows that the core wires were subjected to low-temperature heat treatment by electrical resistance heating in the state after twisting processing under a certain condition for Examples 3, 4, and 5 and then the temperature range was 400 ° C to 495 ° C. After the secondary low-temperature heat treatment (at 450 ° C. for 120 minutes in this embodiment) by atmospheric heating using a heat treatment furnace or the like for 10 minutes to 180 minutes after grinding of the tip 21 of the core wire 2, the first embodiment is performed. Same as ~ 5. FIG. 3 is a graph of Table 3. In Table 3, Examples 6, 7, and 8 correspond to Examples 3, 4, and 5, respectively.

According to Table 3, the rate of increase in tensile fracture strength by the low temperature treatment before the final wire drawing (secondary wire drawing in this example) is the same as in Examples 3 to 5, and each low temperature after the final wire drawing. The total increase rate (2) + (3) + (4) of the tensile fracture strength of the heat treatment was 6.4%, 9.16%, and 9.1% in Examples 6, 7, and 8, respectively. The total increase rate (1) + (2) + (3) + (4) of the tensile fracture strength of each low-temperature heat treatment including the wire drawing step is 18.9% and 22.2 in Examples 6, 7, and 8, respectively. 5% and 21.7%, which are both high values in this embodiment.
The reason for this is that by applying a twisting process of strong working in the cold state (room temperature) in the inclined direction of the long axis in a state where a load is applied to the core wire 2 that has been strongly drawn in the long axis direction of the core wire 2, The mechanical strength is further increased by further promoting the refinement of the grains, and after that, the residual stress due to the processing is reduced by conducting low-temperature heat treatment by electric resistance heating while energizing the core wire as it is (with the load applied to the core wire) It can be considered that it is due to the homogenization of the hardness distribution and the like of the surface layer portion and the inner layer portion of the core wire 2 to a certain limit, and further due to the strong work drawing of the austenitic stainless steel wire described later By grasping the tensile rupture strength characteristics of temperature and adding a suitable temperature and time, nonuniformity such as hardness difference between the surface layer portion and the inner layer portion of the core wire 2 is extremely reduced, and it is made more uniform and localized. Residual response generated in It can be considered by the removal thing, and. In addition, for supplementary reasons, the reason why the temperature range of 380 ° C. to 495 ° C. is set to 30 seconds to 60 minutes as the low temperature heat treatment conditions for electric resistance heating is the same as in Examples 3, 4, and 5.

  Next, FIG. 4 is a diagram in which FIGS. 2 and 3 are combined. From now on, when the core wire is subjected to low-temperature heat treatment by electric resistance heating in the state after twisting, the rate of increase in tensile fracture strength is higher than that obtained by subjecting the core wire to low-temperature heat treatment. There is a sharp increase in the tensile strength at the boundary of 94% area reduction.

  Next, in Tables 4 and 5, after the low-temperature heat treatment (385 ° C., 30 minutes) which is the final heat treatment in Tables 1, 2, and 3, the ground portion of the tip portion 21 of the core wire 2 has a plate width of 0.094 mm and a plate thickness. After pressing into a flat rectangular cross-sectional shape of 0.030 mm, the coil body 3 is attached to the distal end portion 21 of the core wire 2, and then the outer periphery of the coil body 3 is extruded using a thermoplastic resin such as polyurethane or polyamide. When forming a resin film such as a dipping method or a resin shrinkable tube, a resin film forming machine is formed at 180 ° C. to 300 ° C. for 10 seconds to 60 minutes on the outer peripheral portion of the coil body 3 or the outer peripheral portion and the hand portion 22 of the coil body 3. The tensile strength characteristics were shown when low temperature heat treatment was applied to the distal end portion 21 and the proximal portion 22 by heating utilization of a resin shrinkable tube heater or, for example, polyurethane, at 200 ° C. for 5 minutes. With things That. In Table 4, Examples 9, 10, and 11 correspond to Examples 1, 2, and 6, and in Table 5, Examples 12 and 13 correspond to Examples 7 and 8, respectively. The core wire 2 is pressed and subjected to low-temperature heat treatment (200 ° C., 5 minutes).

  According to Tables 4 and 5, low-temperature heat treatment (200 ° C., 5 minutes in this embodiment) in a certain temperature range is performed using the heat at the time of resin film molding of the outer peripheral portion of the coil body 3 after pressing the core wire 2. The rate of increase in tensile strength at break was 1.2%, 1.1%, 1.0% in Examples 9, 10, and 11 and 0.6% in Examples 12 and 13, respectively. it can. Then, when converted to the rectangular cross-sectional area of the core wire 2 at the pressed portion, it can be increased by about 6.6 gf in Examples 9 to 11 and can be increased by about 4.4 gf in Examples 12 and 13. This means that the tensile breaking force between the core wire 2 and the leading plug 5 is around 250 gf, and the joint portion between the core wire 2 and the leading plug 5 requires repeated bending durability by manual operation by the operator within the stenotic lesion. In consideration of the fact that the number of repeated bending durability is expressed by a function of stress (S—N diagram), even a slight increase rate can contribute to improvement in durability, and the present invention This example discloses a new technical idea that partially improves the tensile rupture strength at a required location by using a resin film molding or heating a resin shrinkable tube without using a heat treatment furnace by atmospheric heating. It is.

The tensile breaking strength can be improved even if the heat at the time of molding the resin coating 6 on the outer peripheral portion of the coil body 3 is used. For example, it can be considered to be an extra fine wire shape having a rectangular cross section with a plate width of 0.094 mm and a plate thickness of 0.030 mm, and due to the more averaged stress concentrated locally by pressing. The tip 21 of the core wire 2 is hermetically sealed by the resin coating 6 so that it is difficult to dissipate heat. The tip of the core wire 21 is a thin wire and the tip is a flat extra fine wire that is affected by heat. This is because the austenitic stainless steel wire is easy (low heat capacity) and has a low thermal conductivity and is difficult to cool.
The temperature range was set to 180 ° C. to 300 ° C. because the tensile strength characteristics depending on the temperature of the austenitic stainless steel wire described later (FIG. 8), the melting temperature of the synthetic resin at the time of resin film molding, and the austenitic system This is because the heat conductivity of the stainless steel wire and the heat retaining effect in a sealed state by the resin film molding are considered together. Also, the heating time is set to within 10 to 60 minutes. If the heating time is less than 10 seconds, the effect of improving the tensile strength cannot be obtained, and if the heating time exceeds the upper limit of this range, a remarkable effect cannot be expected. Because. In addition, this heating time includes a time having a heat retention effect after the resin film forming process and the forming process.

Next, according to Tables 4 and 5, the total area reduction rate of the core wire 2 was changed from 90% to 97.6%, and after the mechanical processing such as the grinding processing, the tensile breaking strength of the core wire 2 was obtained by performing the low temperature heat treatment. Is 260 kgf / mm ² or more, considering the stable quality of the product, it can be 250 kgf / mm ² or more, and the total area reduction of the core wire 2 is 96% to 97.6%. Later, by performing the low-temperature heat treatment, the tensile breaking strength of the core wire 2 can be increased to 300 kgf / mm ² or more, and a medical guide wire exhibiting high tensile strength characteristics can be obtained. Since the present invention is a high-strength core wire, it is preferable that the tensile strength at break is 400 kgf / mm ² or less in order to suppress the occurrence of cracks, defects and the like when pressing the tip of the core wire.

  Next, the tensile breaking strength and bending residual angle of the core wire 2 will be described below.

  FIG. 5 shows the tensile strength at break when the number of twists of the core wire 2 was changed (FIG. 5 (a)) and a low-temperature heat treatment (450 ° C., 120 minutes) after the twisting. FIG. 5 shows the tensile strength at break (FIG. 5 (b)) including the variation of 50 samples, and FIG. 6 shows the change in the number of twists of the core wire 2 as in FIG. Bending residual angle after bending test (FIG. 6 (a)) and bending residual angle after bending test when low-temperature heat treatment (450 ° C., 120 minutes) is applied after the twisting (FIG. 6 (b)) Is shown. The bending residual angle after the bending test mentioned here means that the core wire 2 is bent 180 degrees into a round bar having an outer diameter of 15 mm, a load of 500 g is held for 20 seconds, the load is released, and the long axis of the core wire 2 is released. It refers to the residual angle with respect to the direction, that is, the tilt angle that is plastically deformed.

According to FIGS. 5 and 6, the tensile rupture strength has a relatively small fluctuation range when the number of twists is between 100 times / m and 250 times / m. You can't get it. Further, the bending residual angle is small when the number of twists is between 100 times / m and 250 times / m, and if the deviation is outside this range, the fluctuation range becomes large. The reason for this is that if the speed is less than 100 times / m, the number of twists is insufficient and a non-homogeneous portion remains in the major axis direction of the core wire 2, and conversely if it exceeds 250 times / m to 300 times / m, This is because it is considered that a slip line (Rudder's line) with an inclination of approximately 45 degrees in the major axis direction of the core wire is generated, resulting in an over-twisted state, and inhomogeneous portions due to the over-twist are locally scattered. is there. Therefore, the twisting of the present invention does not mean an overtwisting in which the slip line is generated.
The residual bending angle becomes the smallest and stable between 100 times / m and 200 times / m, more preferably from 120 times / m to 180 times / m, and even more preferably from 10% of the number of twists. It is desirable to reverse twist 30%, and most preferably 20%.
Specifically, for example, after twisting in one direction 120 times / m, twisting is performed in the reverse direction 12 times / m to 36 times / m, most preferably 24 times / m in the reverse direction. The reason why this is desirable is to increase the low-temperature heat treatment effect by reverse-twisting and temporarily releasing the stress in the twist direction of strong work twist by reverse twist after strong work twist in one direction, and more linearity This is because it is considered that a high core wire 2 can be obtained.

FIG. 7 is an apparatus diagram for performing twisting processing and electric resistance heating on the core wire 2. The core wire 2 is passed from the bobbin 13 around which the core wire 2 is wound into the heat retaining case 16 through the feed roller 14A, and the core wire 2 is fixed by the rotary chuck 9 and the fixed chuck 10 that can move in the long axis direction of the core wire 2. The core wire 2 is twisted in a predetermined amount in one direction or in the reverse direction by the rotary chuck 9 while the core wire 2 is fixed by the fixed chuck 10 which can be energized by the current generator 8 and loaded with the weight 12. Let Specifically, when the outer diameter of the core wire 2 is 0.340 mm and the fixed span between the chucks 9 and 10 (L in the drawing) is 4000 mm, the weight 12 is loaded on the core wire 2 in one direction from 400 to 800 times. Perform twisting. Most preferably, 20% of the number of twists is applied in the reverse direction, that is, 80 to 160 times in the reverse direction.
Then, after heating the core wire 2 in the state after the twisting, the core wire 2 is unfixed from the rotary chuck 9 and the fixed chuck 10, and the core wire 2 is illustrated by the feed rollers 14A and 14B. The core wire 2 having excellent linearity can be continuously obtained by feeding it to the left side and cutting it with the cutting blade 15 and then repeating this.

  That is, in this process, the core wire 2 wound around the bobbin 13 is sent out into the heat retaining case 16 by electric resistance heating through the feed rollers 14A and 14B (the left side in the figure), and the core wire 2 after feeding is fixed to the rotary chuck 9 A step of fixing with the chuck 10, a step of releasing the stopper 17 of the fixed chuck 10 to which the weight 12 is connected and making the fixed chuck 10 movable in the long axis direction and applying a load (weight 12) to the core wire 2; A step of twisting a predetermined amount of core wire in a predetermined direction by the fixed chuck 9, a step of applying current to the core wire 2 in the heat retaining case 16 kept at a constant temperature by applying a current by the current generator 8, and then operating the stopper 17 A step of preventing the movement of the fixed chuck 10 to the weight 12 side by releasing the fixation of the core wire 2 (the right side in the figure), and a rotation chuck A step of releasing the fixing of the core wire 2 of the clamp 9 and the fixing chuck 10, a step of feeding the core wire 2 by the feed rollers 14 </ b> A and 14 </ b> B (the left side in the figure), a predetermined amount of the core wire 2, and a cutting blade 15 It is a process that can continuously produce the core wire 2 that is twisted and subjected to low-temperature heat treatment by electric resistance heating. Alternatively, the core wire 2 may be preliminarily cut to a predetermined length and then fixed with each chuck, and then twisted as described above, and then subjected to low-temperature heat treatment by electric resistance heating.

And the low-temperature heat processing temperature by electrical resistance heating is 380 degreeC-495 degreeC, and heat processing time is 30 seconds to 60 minutes (this example 450 degreeC, 5 minutes). The weight 12 is preferably 5% to 30%, more preferably 10% to 25%, and most preferably 20% of the tensile breaking strength of the core wire due to the tensile breaking strength of the core wire 2 before the twisting after the final wire drawing step. %.
Specifically, in Example 8, since the wire diameter was 0.228 mm and the tensile strength before twisting after the final wire drawing step (secondary wire drawing) was 302 kgf / mm ² , the core wire was pulled. The breaking force is 12.32 kgf (π × 0.228 × 302 ÷ 4), and the weight 12 is most preferably 2.46 kgf (12.32 × 0.2).
And if it deviates from the range of 5% to 30%, undulation occurs when the weight 12 is light, and breakage occurs during twisting when the weight 12 is heavy, so that the core wire 2 having excellent linearity can be obtained. In addition, productivity cannot be increased. That is, it is important to change the weight of the weight 12 in accordance with the tensile breaking force due to the tensile breaking strength before twisting of the core wire 2. Here, the tensile breaking force means the maximum load when the core wire is broken by applying a tensile force.
As described above, the electrical resistance heating and twisting conditions are low-temperature heat treatment conditions by electrical resistance heating at 380 ° C. to 495 ° C. for 30 seconds to 60 minutes, and the number of twists is 100 times / m to 250 times / m. And preferably 100 times / m to 200 times / m, more preferably 120 times / m to 180 times / m, and still more preferably 10% to 30% of the number of twists in the reverse direction, and weight 12 Is preferably 5% to 30%, most preferably 20% of the tensile breaking strength of the core wire by the tensile breaking strength before twisting. And satisfy | filling all these conditions can satisfy quality, such as a tensile strength characteristic, linearity, and rotation transmission property which are requested | required as a medical guide wire.

Next, FIG. 8 is a view showing the temperature and tensile strength characteristics of the core wire 2 subjected to low-temperature heat treatment after the final wire drawing step of Example 3 or 6, and the austenite system having a wire diameter of 1.5 mm and subjected to solid solution treatment. Under the influence of heat when an outer diameter of 0.140 mm is obtained by grinding the core wire 2 having an outer diameter of 0.340 mm obtained by drawing a stainless steel wire (SUS304) with a total area reduction ratio of 94.8% (each temperature for 30 minutes) This shows the tensile strength characteristics during heating.
According to this, the tensile strength at break begins to increase due to the heat effect at 180 ° C., shows the highest tensile strength at about 450 ° C., and the effect of improving the tensile strength property is noticeable up to 495 ° C., and from 500 ° C. to 520 ° C. If it exceeds ℃, the tensile rupture strength decreases more rapidly than at normal temperature (20 ℃).
The reason why the tensile strength at break is drastically lowered is that, as described above, when the solution-treated austenitic stainless steel wire is heated from 500 ° C. to 850 ° C., it causes carbon precipitation and chromium migration. Energy is required and a sensitization phenomenon occurs. In particular, in a normal SUS304 austenitic stainless steel wire having a carbon content of 0.08% or less, this sensitization phenomenon appears at 700 ° C. for 4 to 5 minutes, and tensile fracture occurs. The strength is extremely reduced.

This appears remarkably in the thin line at the tip 21 of the core wire 2 that is easily affected by heat. For example, the circular cross-sectional shape 23 of the distal end portion 21 of the core wire 2 shown in FIG. 1 (c) has an outer diameter of about 0.060 mm to 0.150 mm, and this is an extension having an outer diameter of about 0.340 mm. The austenitic stainless steel wire that has been subjected to wire processing is subjected to outer peripheral grinding to the above-described dimensions using a coreless grinding machine or the like.
And the tensile breaking strength at this time (FIG. 8), for example, when it is 250 kgf / mm ² at room temperature, the tensile breaking strength becomes 266 kgf / mm ² by heating at 180 ° C., and increases by about 6.4%. In the case of ℃, the tensile breaking strength is improved to 290 kgf / mm ² , increased by about 16%, and in terms of the sectional area of the tensile breaking force when the outer diameter of the core wire 2 at the tip end portion 21 of the core wire is 0.060 mm 706 gf becomes 819 gf, and the tensile strength of about 113 gf increases. Thereafter, even at 495 ° C., the tensile strength at break is 260 kgf / mm ² , which is about 4% higher than that at room temperature.
When the temperature exceeds 500 ° C. to 520 ° C., the tensile breaking strength decreases due to a sensitization phenomenon or the like, and the tensile breaking strength up to 600 ° C. becomes 210 kgf / mm ^2. In other words, about 819 gf becomes about 593 gf, and the tensile strength is significantly lowered, and the core wire 2 of the distal end portion 21 is broken by an extremely low tensile force. The value of 250 kgf / mm ² at room temperature for the tensile breaking strength in FIG. 8 varies depending on the total area reduction ratio in the wire drawing process, and the temperature and tensile breaking strength characteristics at this time. Shows the same tendency as described above.

  In particular, when the joining member 4 is used, if the eutectic alloy, which is the joining member 4 considering the tensile strength characteristics of the core wire 2 due to the thermal effect, is not used, the work hardening is performed by wire drawing by strong working. In spite of the core wire 2 having increased tensile strength characteristics, the tensile strength is reduced due to the heat of fusion of the joining member when the core wire 2 and the coil body 3 are joined. Further, the joint between the leading plug 5 and the core wire 2 is broken due to bending fatigue, and the leading plug 5 may be detached.

Since it has such tensile strength characteristics, the low temperature heat treatment temperature range of the core wire 2 is desirably 180 ° C. to 495 ° C., and the low temperature heat treatment temperature 450 ° C. after the final wire drawing in Tables 1, 2, and 3 is a preferable condition. In addition, the effect is remarkable even in the low-temperature heat treatment at 385 ° C. using the heat of forming a fluororesin (PTFE) film after mechanical processing, and after pressing the core wire 2 as shown in Tables 4 and 5 above. The tensile strength at break can be improved even in a low-temperature heat treatment at 200 ° C. using resin film forming heat on the outer periphery of the coil body 3. (Fig. 8)
As described above, the present invention focuses on the tensile strength characteristics depending on the temperature of the austenitic stainless steel wire with high work drawing and a high total area reduction rate, and performs a suitable low temperature heat treatment after the drawing, and within a certain temperature range. Providing a new technical concept that can significantly improve the tensile strength characteristics of the core wire 2 by taking into account heat retention, thermal conductivity, structure, and materials, using heat during resin film molding in a controlled state To do.

  Next, a core wire drawing method for having the tensile strength characteristics as described above will be described below with reference to Example 6.

As described above, in order to obtain a core wire 2 having a high strength tensile strength characteristic as shown in FIG. 8 using a solution-treated austenitic stainless steel wire, the total area reduction rate is simply 94.8%. It is not obtained only by wire drawing. For example, in Examples 3 and 6, a solidified austenitic stainless steel wire having a wire diameter of 1.5 mm was continuously used by using a plurality of dies (10 to 20 pieces) each having a surface area reduction rate of 4% to 20%. Performs primary wire drawing to a wire diameter of 0.5 mm by wire drawing (area reduction rate: 88.9%), followed by low-temperature heat treatment (420 ° C., 75 minutes), and constant surface reduction as with primary wire drawing. Secondary drawing (53.8% area reduction) is performed by continuous drawing using a plurality of dies (5 to 8) having a rate to a wire diameter of 0.340 mm, and the total area reduction rate is 94.8. %, The core wire 2 having a desired tensile strength characteristic and the tip portion 21 thereof can be obtained. At this time, the area reduction rate of the primary wire drawing is smaller than the area reduction rate of the secondary wire drawing, so that the crystal grain size is reduced, and from the viewpoint of economy, productivity improvement, etc. desirable.
In addition, in the case of drawing a high-strength material as in the present embodiment, a diamond die that is more excellent in wear resistance than an alloy die is desirable.

  In the final wire drawing step, the area reduction rate is 4% to 20%. Using the plurality of dies (5 to 8), the area reduction ratio of the final die out of the plurality of dies (5 to 8). By making the die arrangement having the smallest surface area reduction ratio in the final wire drawing process from 4% to 13%, disconnection in the final wire drawing process can be prevented, productivity is high, and stable quality is achieved. A core wire can be obtained. Further, the chemical components of the austenitic stainless steel wire of this example are C: 0.15% or less, Si: 1% or less, Mn: 2% or less, Ni: 6% to 16%, Cr: 16 by weight%. %: 20%, P: 0.045% or less, S: 0.030% or less, Mo: 3% or less, balance iron and inevitable impurities. Thus, even if it does not use high silicon stainless steel (Si: 3.0%-5.0%), the core wire 2 of a high-strength austenitic stainless steel wire can be obtained by using the said process. Typically, SUS304 and SUS316 material.

  Next, another method for enhancing the low-temperature heat treatment effect will be described below because the tensile strength characteristics when the solution-treated austenitic stainless steel wire is drawn and subjected to low-temperature heat treatment are shown in FIG. To do.

  As shown in FIG. 8, since the low temperature heat treatment temperature is 180 ° C. to 495 ° C. and the effect of improving the tensile breaking strength is obtained, the joining members 41, 42, 43 that partially join the core wire 2 and the coil body 3 or The tensile strength at break can also be improved by using a eutectic alloy having a melting temperature of 180 to 495 ° C. for the leading plug 5. Specifically, the joining members 41 and 42 are donut-shaped substantially disk shapes having a width of about 0.3 mm to 1.5 mm and an outer diameter of about 0.228 mm to 0.340 mm, and the rear end joining member 43. Is a joint between the radiation transmitting coil member 32 and the core wire 2 having a wire diameter of about 0.200 mm to 0.340 mm. The joint shape is about 0.3 mm to 3 mm in width and the outer diameter is about 0.228 mm to 0. A disc shape of about 340 mm, or a substantially conical shape with a tapered side. In addition, to join partially using the joining member 4 here means the joining form of each joining member 41-43 and the leading plug 5 in the said example.

  And the eutectic alloy used for the joining member 4 here means a special alloy having the lowest melting point (melting temperature) obtained by changing the component ratio of the alloy, specifically, gold or silver. 80% by weight as a gold-tin alloy material with a balance of tin and a melting temperature of 280 ° C., and 3.5% by weight of silver as a silver-tin alloy, with a balance of tin and a melting temperature of 221 ° C., and An eutectic alloy consisting of 88% by weight of gold, the balance being germanium and a melting temperature of 356 ° C., consisting of silver, tin and indium and having a melting temperature of 450 ° C. to 472 ° C. is shown in Table 6.

For example, as shown in FIG. 10, each interval between the intermediate joining member 411 and the intermediate joining members 412 and 413 located 50 mm (A dimension in the figure) from the tip of the leading plug 5 is set to 10 mm (B dimension in the figure). By arranging 10 intermediate joining members and setting the total length between the intermediate joining members to 90 mm, low-temperature heat treatment is performed over a long position (90 mm in the figure) of the core wire 2 even when a joining member that is partially joined is used. The tensile strength characteristic of the core wire 2 can be improved.
According to this method, it is possible to improve the tensile strength of the core wire 2 at a necessary portion even without using a heat treatment furnace that uses atmospheric heating for overall heating, even within a certain narrow range. Furthermore, in this structure, by arranging the intermediate joint members 411, 412, and 413 at equal intervals, it is possible to have an effect that the length of the stenotic lesion can be measured. The reason why the position and the range of the intermediate joint member are the above dimensions is that this range corresponds to a stenotic lesion position generally observed in the coronary artery.
If it supplements, by using the joining member 4 which is a eutectic alloy for the leading plug 5, the tensile fracture strength of the core wire 2 in the junction part of the leading plug 5 and the core wire 2 can be improved, As a result, a stenosis lesion The bending fatigue resistance characteristics at the joint can be improved. In addition, in addition, in this joining process, the coil body 3 is attached to the outer peripheral portion of the tip 21 after the low-temperature heat treatment (385 ° C., 30 minutes) after the grinding process of the mechanical processing of the tip 21, and then joined. Using the member 4, the joining members 41 to 43, 411, 412, 413 and the leading plug 5 are joined. Thereafter, a step of applying a resin coating to the outer peripheral portion of the coil body 3 is performed.

Next, by using the medical guide wire having the core wire 2 of the present invention, the core wire 2 can be reduced in diameter by utilizing the effect of improving the tensile strength characteristics of the core wire 2. For example, the outer diameter of the proximal portion 22 of the medical guide wire 1 is changed from 0.355 mm to 0.254 mm (0.014 inch to 0.010 inch), the molding heat of the resin coating 6, and the resin coating in the coil body 3 The tensile strength characteristics of the core wire 2 at the tip 21 can be improved by utilizing the residual heat in the sealed state, and as a result, the outer diameter of the core wire 2 is reduced to 0.228 mm (0.009 inch). it can.
Then, a medical guide wire is inserted into the microcatheter, and the guide wire and the microcatheter are inserted into the guiding catheter. In such a case, the guiding catheter is changed from 7F to 8F to 5F to 6F (inner diameter 2.3 mm to 2.7 mm to inner diameter 1.59 mm to 2.00 mm) following the thinning of the medical guide wire 1. The diameter can be reduced with a microcatheter (inner diameter 0.28 mm to 0.90 mm) inserted therein. Thereby, the request | requirement of minimally invasiveness can be met and it can contribute to a patient burden reduction. If supplemented, the microcatheter is introduced to the end of the stenotic lesion together with the medical guidewire, and the reaction force of the force pushing the front of the medical guidewire is supported by the microcatheter, whereby the medical guidewire The forward driving force can be demonstrated. The microcatheter has a multi-layer resin tube and a structure in which a braid of metal wires is interposed in the multi-layer resin tube, and a substantially conical metal tip is fixed to the distal end portion so that a plurality of thin metal wires are arranged. The spiral tube body that is formed of a spiral tube body formed into a strip coil body and that can be perforated in a stenotic lesion is also included.

  And next, by using the medical guide wire having the core wire 2 of the present invention as described above, for example, the outer diameter of the proximal portion 22 of the medical guide wire 1 is 0.355 mm to 0.254 mm (from 0.0014 inch). 0.010 inch) and further 0.228 mm (0.009 inch) diameter, and a medical guide wire is inserted into the balloon catheter and the guide wire and balloon catheter are inserted into the guiding catheter. And insert. In such a case, the guiding catheter is changed from 7F to 8F to 5F to 6F (inner diameter 2.3 mm to 2.7 mm to inner diameter 1.59 mm to 2.00 mm) following the thinning of the medical guide wire 1. The diameter can be reduced with a balloon catheter (inner diameter 0.28 mm to 0.90 mm) inserted therein. Thereby, the request | requirement of minimally invasiveness can be met and it can contribute to a patient burden reduction. If supplemented, a kissing procedure can be easily performed by inserting two sets of medical guidewires and balloon catheters into the guiding catheter. The kissing technique here refers to the branching site of the bifurcated lesion by inserting two pairs of medical guide wires and a balloon catheter into the guiding catheter and simultaneously expanding the balloon catheter balloon at the bifurcated lesion. This refers to a procedure that simultaneously expands the stenotic lesion.

[Effect of the invention]
As described above, the medical guide wire of the present invention and the manufacturing method thereof are suitable by paying attention to the temperature-dependent tensile strength characteristics of the austenitic stainless steel wire that has been subjected to strong wire drawing close to the wire drawing limit. Repeats wire drawing and low temperature heat treatment in a certain temperature range, and performs twisting and low temperature heat treatment to obtain linearity and rotation transmission as a medical guide wire. A medical guide wire having a high tensile strength characteristic and a method for manufacturing the same are provided by accumulating the effect of improving the tensile strength of the core wire for each processing step peculiar as a medical guide wire by applying heat treatment. It is.

And further, after the mechanical processing of the distal end portion 21 of the core wire 2, use of drying / firing heating of the outer peripheral resin film molding at a relatively high temperature, and after the grinding processing of the distal end portion 21 of the core wire 2, and Focusing on the correlation between heating at the outer periphery of the coil body 3 after pressing and the tensile strength characteristics due to the temperature of the hard-working core wire, by applying low-temperature heat treatment controlled to a certain temperature range, the core wire The present invention provides a new technical idea for improving the tensile strength characteristics, etc., even if 2 is wholly or partially.
As a result, the mechanical strength characteristics can be further improved and the quality can be stabilized while the distal end portion of the medical guide wire is an extra fine wire. There are the above various effects.

DESCRIPTION OF SYMBOLS 1 Guide wire (medical guide wire) 5 Lead plug 2 Core wire 6 Resin coating 21 Tip part (core wire) 7 Hydrophilic coating 3 Coil spring body (coil body) 8 Current generator 31 Radiopaque material coil 9 Rotary chuck 32 Radiation Transmission material coil 10 Fixed chuck 4 Joining member 11 Moving roller 41 Intermediate front joining member 12 Weight 42 Middle rear joining member 13 Bobbin 43 Rear end joining member 14A Feeding roller
14B feed roller
15 Cutting blade

Claims (15)

A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In the formed medical guidewire,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step of 400 ° C. to 495 ° C. is provided after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
The total increase rate of tensile fracture strength by low-temperature heat treatment until the final wire drawing step is 8% or more,
Low-temperature heat treatment at 380 ° C. to 495 ° C. after the final wire drawing,
After subjecting the core wire tip to grinding or pressing, mechanical processing is applied to at least the mechanically processed portion at a low temperature of 180 ° C. to 420 ° C.,
The total increase rate of tensile fracture strength by each low-temperature heat treatment after the final wire drawing step is 2% or more,
A medical guide wire, wherein the total increase rate of tensile breaking strength by each of the low-temperature heat treatments is 10% or more. A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In a medical guide wire formed and formed with a resin coating on at least the outer peripheral portion of the core wire proximal portion,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step of 400 ° C. to 495 ° C. is provided after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
The total increase rate of tensile fracture strength by low-temperature heat treatment until the final wire drawing step is 8% or more,
After the final wire drawing step, a predetermined amount of twisting is performed on the core wire, and then the core wire is subjected to low temperature heat treatment at 380 ° C. to 495 ° C. by electric resistance heating,
Then, after grinding or pressing mechanical processing on the core wire tip, using the heat of resin film forming on the outer periphery of the core wire, low temperature heat treatment of 340 ° C ~ 420 ° C,
The total increase rate of tensile fracture strength by each low-temperature heat treatment after the final wire drawing step is 2% or more,
A medical guide wire, wherein the total increase rate of tensile breaking strength by each of the low-temperature heat treatments is 10% or more. The medical guidewire according to claim 2,
After mechanical processing of the tip of the core wire, a low temperature heat treatment step of 400 ° C. to 495 ° C. is provided before resin film molding of the outer peripheral portion of the core wire,
Increasing the tensile breaking strength relative to the tensile breaking strength after mechanical processing of the core wire,
A medical guide wire characterized in that the total increase rate of tensile breaking strength by each of the low-temperature heat treatments is 11.5% or more. Using the core wire according to any one of claims 1 to 3, a coil spring body that is inserted through the core wire is attached to a tip end portion of the core wire, and a tip end portion of the core wire and the coil spring body is attached. In a medical guide wire in which a leading plug is formed using a joining member, and a resin film is formed at least on the outer periphery of the coil spring body,
After the low-temperature heat treatment of the ground portion of the core wire tip, press processing is performed,
Perform a low-temperature heat treatment at 180 ° C. to 300 ° C. using the resin film forming heat of the outer periphery of the tip coil spring body on at least the pressed portion,
A medical guide wire characterized in that at least the tensile breaking strength of a grounded portion or a pressed portion of the core wire tip is increased with respect to the tensile breaking strength before low-temperature heat treatment of the resin film molding. The medical guidewire according to any one of claims 1 to 4,
A medical guide wire characterized in that the total area reduction ratio until the final wire drawing of the core wire is 94% to 97.6%. A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In the formed medical guidewire,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step is performed at 400 to 495 ° C. for 10 minutes to 180 minutes after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
In the state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire, the other end is provided with a twisting process of 100 times / m to 250 times / m,
Then, a low-temperature heat treatment step for 30 seconds to 60 minutes at 380 ° C. to 495 ° C. by electric resistance heating on the core wire,
Grinding the core wire tip, or pressing after grinding, and
Attaching the coil spring body by inserting the core wire through the tip of the core wire;
A step of partially bonding the core wire and the coil spring body using the bonding member;
A method for producing a medical guide wire, comprising: forming a leading plug in which the core wire and an end of the coil spring body are joined using the joining member. A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In the formed medical guidewire,
Using the austenitic stainless steel wire in which the core wire is subjected to solution treatment,
After the wire drawing step and the wire drawing step, a low temperature heat treatment step is performed at 400 ° C. to 495 ° C. for 10 minutes to 180 minutes, and the wire drawing step and the low temperature heat treatment step are set as one set and at least one set is repeated after each step is completed. Provide a wire drawing process
The total area reduction until the final wire drawing step is 90% to 97.6%,
In the state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire, the other end is provided with a twisting process of 100 times / m to 250 times / m,
Then, a low-temperature heat treatment step for 30 seconds to 60 minutes at 380 ° C. to 495 ° C. by electric resistance heating on the core wire,
After that, a low temperature heat treatment step is performed at 400 to 495 ° C. for 10 to 180 minutes,
Then, the step of pressing the core wire tip after grinding or grinding,
Attaching the coil spring body by inserting the core wire through the tip of the core wire;
A step of partially bonding the core wire and the coil spring body using the bonding member;
A method for producing a medical guide wire, comprising: forming a leading plug in which the core wire and an end of the coil spring body are joined using the joining member. A core wire made of a flexible elongated body, a coil spring body having the core wire inserted through the distal end portion of the core wire, and a leading plug using a joining member at the distal end ends of the core wire and the coil spring body In a medical guide wire formed and formed with a resin coating on at least the outer peripheral portion of the core wire proximal portion,
Using the austenitic stainless steel wire in which the core wire is subjected to a solution treatment, a low-temperature heat treatment step is performed at 400 to 495 ° C. for 10 minutes to 180 minutes after the wire drawing step and the wire drawing step,
The wire drawing step and the low temperature heat treatment step are set as one set, and after each step is repeated at least one set, a final wire drawing step is provided.
The total area reduction until the final wire drawing step is 90% to 97.6%,
In the state where a load of 5% to 30% of the tensile breaking force of the core wire before twisting is applied to one end of the core wire, the other end is provided with a twisting process of 100 times / m to 250 times / m,
Then, a low-temperature heat treatment step for 30 seconds to 60 minutes at 380 ° C. to 495 ° C. by electric resistance heating on the core wire,
Grinding the core wire tip, or pressing after grinding, and
Forming a resin film on at least the proximal portion of the core wire;
Then, at least the core wire tip is ground, or a low temperature heat treatment step is performed at 340 ° C. to 420 ° C. for 10 minutes to 180 minutes on the pressed portion after grinding,
Inserting the coil spring body through the core wire; and
A step of partially bonding the core wire and the coil spring body using the bonding member;
A method for producing a medical guide wire, comprising: forming a leading plug in which the core wire and an end of the coil spring body are joined using the joining member. In the manufacturing method of the medical guidewire as described in any one of Claims 6-8,
A medical guide wire manufacturing method, characterized in that the twisting process of the other end of the core wire is performed at a twisting process of 100 times / m to 200 times / m. In the manufacturing method of the medical guidewire as described in any one of Claims 6-9,
After joining the core wire and the coil spring body using the joining member,
A resin coating is formed on the outer peripheral portion of the coil spring body, and a low-temperature heat treatment step is performed at 180 ° C. to 300 ° C. for 10 minutes to 60 minutes at least at the tip end portion of the core wire in the coil spring body by utilizing heat at the time of molding the resin coating. A method for manufacturing a medical guide wire, comprising: In the manufacturing method of the medical guidewire as described in any one of Claims 6-10,
The wire drawing step of the core wire is continuously drawn using a plurality of dies having a surface reduction rate of 4% to 20% in each drawing step from the primary drawing to the final drawing,
In the final drawing process, continuous drawing is performed using a plurality of dies with a reduction in area of 4% to 20%, and the final die has a reduction in area of 4% to 13%, which is the most reduced in the final drawing process. A method of manufacturing a medical guide wire, characterized by comprising a core wire in a wire drawing process in which dies having a small surface area are arranged.   The medical guide wire according to any one of claims 1 to 5, wherein the joining member is made of a eutectic alloy having a melting temperature of 180 ° C to 495 ° C.   The method of manufacturing a medical guide wire according to any one of claims 6 to 11, wherein the joining member is made of a eutectic alloy having a melting temperature of 180 ° C to 495 ° C. In the assembly of the medical guidewire according to any one of claims 1 to 5 and 12, a microcatheter, and a guiding catheter,
The medical guide wire is inserted into a microcatheter having an outer diameter of 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) and an inner diameter of 0.28 mm to 0.90 mm. The medical guide wire, the microcatheter, and the guiding catheter are inserted into the guiding catheter having an inner diameter of 1.59 mm to 2.00 mm. And assembly. In the assembly of the medical guidewire according to any one of claims 1 to 5 and 12, a balloon catheter, and a guiding catheter,
The medical guide wire has an outer diameter of 0.228 mm to 0.254 mm (0.009 inch to 0.010 inch) and the medical guide wire is inserted into the balloon catheter having an inner diameter of 0.28 mm to 0.90 mm. The medical guide wire, the balloon catheter, and the guide are inserted into the guiding catheter having an inner diameter of 1.59 mm to 2.00 mm. Assembly with ding catheter.

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