The present invention relates to wires suitable for medical treatment instruments and guide wires having cores which are obtained from the wires.
In tests and treatments using catheters, a guide wire is inserted in a blood vessel. The catheter is inserted in the blood vessel along the guide wire. The catheter is moved into the blood vessel while being guided by the guide wire. After the leading end of the catheter has reached a predetermined position, the guide wire is removed from the blood vessel. A contrast medium or the like is administered through the catheter.
The guide wire has a core and a cover that covers the core. The guide wire is used for a human body, and, therefore, the core needs to be corrosion-resistant. Austenitic stainless steel is preferably used for the core.
The blood vessel is bent, and, therefore, the guide wire inserted in the blood vessel is moved thereinto while being bent. A doctor may repeatedly move the guide wire forward and backward in order to cause the guide wire to pass through a narrow portion. The breakage of the core needs to be prevented even in such a usage. In other words, the core needs to be fatigue-resistant.
A doctor operates a portion, of the guide wire, which is located outside the human body, in a state where the guide wire is inserted in a blood vessel. In this operation, the doctor rotates the guide wire. The torque of the rotation is transmitted to the leading end of the guide wire. The core needs to have torque transmittability.
An example of the guide wire having excellent fatigue resistance and torque transmittability is disclosed in JP2009-172229.
Patent Literature 1: JP2009-172229
A human body has a portion in which a blood vessel is bent at a steep angle. A high bending stress is applied to the core of the guide wire that passes through the portion. Therefore, a fatigue resistance needs to be increased for the core of the guide wire that passes through the portion. Thus, a wire as a material of the core also needs to have a high fatigue resistance.
A wire used in this medical treatment instrument may be required to have a high fatigue resistance, also when used for various medical treatment instruments other than the guide wire.
An object of the present invention is to provide a wire, for medical treatment instruments, having extremely excellent fatigue resistance.
In a wire, for a medical treatment instrument, according to the present invention, a contour of a cross-section perpendicular to a longitudinal direction is a circle having a diameter of D. On the cross-section, a standard deviation σ of Vickers hardnesses at eight measurement points that are equally spaced from each other on an imaginary circle which is concentric with the circle and has a diameter of (¾)D, is not greater than 10.
Preferably, an average of the Vickers hardnesses at the eight measurement points is not less than 670 and not greater than 770.
Preferably, a material of the wire for a medical treatment instrument is a stainless steel.
Preferably, a tensile strength of the wire for a medical treatment instrument is not less than 2600 MPa.
Preferably, a straightness of the wire for a medical treatment instrument is not greater than 0.10 mm when a length of the wire is 2.00 m.
From another viewpoint, a guide wire according to the present invention has a core. A contour of the core on a cross-section perpendicular to a longitudinal direction is a circle having a diameter of D. On the cross-section, a standard deviation σ of Vickers hardnesses at eight measurement points that are equally spaced from each other on an imaginary circle which is concentric with the circle and has a diameter of (¾)D, is not greater than 10.
Preferably, an average of the Vickers hardnesses at the eight measurement points is not less than 670 and not greater than 770.
Preferably, a material of the core is a stainless steel.
Preferably, a tensile strength of the core is not less than 2600 MPa.
The inventor of the present invention has found that the wire for a medical treatment instrument is broken due to concentration of stress. The inventor of the present invention has found that the concentration of the stress is caused by variation in hardness in the circumferential direction of the wire. In the wire, for a medical treatment instrument, according to the present invention, the standard deviation σ of the Vickers hardnesses is small. The wire has an excellent fatigue resistance.
The following will describe in detail the present invention based on preferred embodiments with reference where appropriate to the accompanying drawing.
In
A first measurement point M1 is assumed on the imaginary circle 4. The position of the first measurement point M1 is randomly determined. Next, a second measurement point M2 is assumed, on the imaginary circle 4, at a position distant from the first measurement point M1 by 45° as the central angle of the imaginary circle 4. Similarly, a third measurement point M3, a fourth measurement point M4, a fifth measurement point M5, a sixth measurement point M6, a seventh measurement point M7, and an eighth measurement point M8 are assumed in increments of 45°. These eight measurement points are disposed on the imaginary circle 4 at equal pitch angles.
For each of the eight measurement points, a Vickers hardness (Hv) is measured. The Vickers hardness is measured by using a micro Vickers hardness tester in compliance with “JIS Z 2244:2009”. The measurement condition is as follows.
Temperature: 23° C.
Load: 100 gf
Since the number of the measurement points is eight, eight measurement values (Vickers hardnesses) are obtained. A standard deviation σ of these measurement values is calculated. The standard deviation σ is preferably not greater than 10. In the wire 2, for a medical treatment instrument, in which the standard deviation σ is not greater than 10, concentration of stress in the circumferential direction is inhibited. The wire 2 has an excellent fatigue resistance. The wire 2 is not easily broken when used for a human body. From this viewpoint, the standard deviation σ is more preferably not greater than 8 and particularly preferably not greater than 5. Idealistically, the standard deviation σ is zero.
The average Av of these eight measurement values (Vickers hardnesses) is preferably not less than 670 and preferably not greater than 770. The wire 2, for a medical treatment instrument, for which the average Av is not less than 670 has excellent torque transmittability. From this viewpoint, the average Av of the Vickers hardnesses is more preferably not less than 690 and particularly preferably not less than 700. The wire 2 for which the average Av is not greater than 770 is not brittle. Therefore, the wire 2 is not easily broken. From this viewpoint, the average Av is more preferably not greater than 750 and particularly preferably not greater than 740.
A ratio of the standard deviation σ to the average Av of the Vickers hardnesses is preferably not greater than 2.0%. In the wire 2, for a medical treatment instrument, for which the ratio is not greater than 2.0%, concentration of stress in the circumferential direction is inhibited. The wire 2 has an excellent fatigue resistance. The wire 2 is not easily broken when used for a human body. From this viewpoint, the ratio is more preferably not greater than 1.5% and particularly preferably not greater than 0.7%. Idealistically, the ratio is zero.
At the point P3, a first cross-section is obtained by the wire 2 being cut. The first cross-section is perpendicular to the length direction of the wire 2. On the first cross-section, the first measurement point M1, the second measurement point M2, the third measurement point M3, the fourth measurement point M4, the fifth measurement point M5, the sixth measurement point M6, the seventh measurement point M7, and the eighth measurement point M8 are assumed as described above. At each of these measurement points, the Vickers hardness is measured. At the first cross-section, the standard deviation σ, the average Av, and the ratio (o/Av) are achieved within the above-described ranges.
At the point P4, a second cross-section is obtained by the wire 2 being cut. The second cross-section is perpendicular to the length direction of the wire 2. On the second cross-section, the first measurement point M1, the second measurement point M2, the third measurement point M3, the fourth measurement point M4, the fifth measurement point M5, the sixth measurement point M6, the seventh measurement point M7, and the eighth measurement point M8 are assumed as described above. At each of these measurement points, the Vickers hardness is measured. Also at the second cross-section, similarly to the first cross-section, the standard deviation σ, the average Av, and the ratio (σ/Av) are achieved within the above-described ranges.
At the point P5, a third cross-section is obtained by the wire 2 being cut. The third cross-section is perpendicular to the length direction of the wire 2. On the third cross-section, the first measurement point M1, the second measurement point M2, the third measurement point M3, the fourth measurement point M4, the fifth measurement point M5, the sixth measurement point M6, the seventh measurement point M7, and the eighth measurement point M8 are assumed as described above. At each of these measurement points, the Vickers hardness is measured. Also at the third cross-section, similarly to the first cross-section, the standard deviation σ, the average Av, and the ratio (σ/Av) are achieved within the above-described ranges.
After the process by the device 6 shown in
The number of corrective units: 2
Positions at which the corrective units are mounted: preceding and following the final die
The number of the corrective rollers: 9 to 13 Tension of the base wire at the outlet of the corrective machine: 40% to 70% of breaking load
Preferably, the heat treatment is performed in a hydrogen atmosphere. In the heat treatment in this atmosphere, heat is transmitted to the base wire in a short time. The temperature for the heat treatment is 500° C. to 650° C.
The material of the wire 2 is preferably a stainless steel. A stainless steel has excellent corrosion resistance and strength. Specific examples of the stainless steel include austenitic stainless steels, ferritic stainless steels, martensitic stainless steels, precipitation hardening stainless steels, and duplex stainless steels. The austenitic stainless steel is preferably used. Other preferable materials of the wire 2 are Ni—Ti alloys and Ti alloys.
A tensile strength of the wire 2 is preferably not less than 2600 MPa. The wire 2 having the tensile strength of not less than 2600 MPa has an excellent pushability when the wire 2 is moved into a human body. From this viewpoint, the tensile strength is more preferably not less than 2700 MPa and particularly preferably not less than 2800 MPa. The tensile strength is preferably not greater than 3000 MPa.
The tensile strength is measured in compliance with “JIS Z 2241 (2011)”. The measurement condition is as follows.
Temperature: 23° C.
Tensile rate: 10 mm/min
Distance between evaluation points: 100 mm
The straightness S of the wire 2 is preferably not greater than 0.10 mm. The wire 2 for which the straightness S is not greater than 0.10 mm has excellent torque transmittability. From this viewpoint, the straightness S is more preferably not greater than 0.05 mm and particularly preferably not greater than 0.02 mm. Idealistically, the straightness S is zero.
The cover 40 covers the core 42. The cover 40 is formed from a synthetic resin. The synthetic resin is typically Teflon resin. The cover 40 allows achievement of smoothness for inserting the guide wire 34 in a blood vessel.
The core 42 includes a main portion 48 and a tapered portion 50. The wire diameter is substantially uniform in the main portion 48. In the main portion 48, the wire diameter is typically 0.25 mm to 0.50 mm. The diameter of the tapered portion 50 decreases toward the leading end 36.
The coil 44 is wound around the tapered portion 50. The coil 44 reinforces the tapered portion 50 without reducing flexibility of the tapered portion 50. The binder 46 is fixed to the core 42.
The core 42 is formed from the wire 2, for a medical treatment instrument, shown in
As described above, the core 42 is formed from the wire 2, for a medical treatment instrument, shown in
Since the core 42 has the tapered portion 50, the Vickers hardness cannot be measured in the method shown in
At the point P10, the core 42 is cut to obtain a first cross-section. The first cross-section is perpendicular to the length direction of the core 42. On the first cross-section, the first measurement point M1, the second measurement point M2, the third measurement point M3, the fourth measurement point M4, the fifth measurement point M5, the sixth measurement point M6, the seventh measurement point M7, and the eighth measurement point M8 are assumed as described above. At each of these measurement points, the Vickers hardness is measured. At the first cross-section, the standard deviation σ, the average Av, and the ratio of the standard deviation σ to the average Av are achieved within the above-described ranges.
At the point P11, the core 42 is cut to obtain a second cross-section. The second cross-section is perpendicular to the length direction of the core 42. On the second cross-section, the first measurement point M1, the second measurement point M2, the third measurement point M3, the fourth measurement point M4, the fifth measurement point M5, the sixth measurement point M6, the seventh measurement point M7, and the eighth measurement point M8 are assumed as described above. At each of these measurement points, the Vickers hardness is measured. Also at the second cross-section, similarly to the first cross-section, the standard deviation σ, the average Av, and the ratio of the standard deviation σ to the average Av are achieved within the above-described ranges.
At the point P12, the core 42 is cut to obtain a third cross-section. The third cross-section is perpendicular to the length direction of the core 42. On the third cross-section, the first measurement point M1, the second measurement point M2, the third measurement point M3, the fourth measurement point M4, the fifth measurement point M5, the sixth measurement point M6, the seventh measurement point M7, and the eighth measurement point M8 are assumed as described above. At each of these measurement points, the Vickers hardness is measured. Also at the third cross-section, similarly to the first cross-section, the standard deviation σ, the average Av, and the ratio of the standard deviation σ to the average Av are achieved within the above-described ranges.
The following will show the effects of the present invention by means of examples, but the present invention should not be construed in a limited manner based on the description of these examples.
A base wire formed from SUS304 as a material was repeatedly subjected to wire drawing and heat treatment. By the wire drawing, the base wire was elongated while the diameter of the base wire was being reduced. In the final wire drawing process step, a corrective process was performed by corrective units disposed preceding and following a finishing die. In the final wire drawing process step, the wire diameter was 0.35 mm. The condition for the correction was as follows.
Diameter of corrective roller: 10 mm
The number of corrective rollers: 11
Tension of base wire at corrective unit:
The base wire having been subjected to the final wire drawing was annealed at a low temperature, to obtain a core for a guide wire. The condition for the low temperature annealing was as follows.
A core of example 2 was obtained in the same manner as in example 1 except that the number of corrective rollers at a corrective unit was as follows.
The number of corrective rollers: 9
A core of example 3 was obtained in the same manner as in example 1 except that tension of a base wire at a corrective unit was as follows.
Tension of base wire at corrective unit:
A core of example 4 was obtained in the same manner as in example 3 except that the number of corrective rollers at a corrective unit was as follows.
The number of corrective rollers: 9
A core of comparative example 1 was obtained in the same manner as in example 1 except that no corrective units were used in the final wire drawing process step.
A core of comparative example 2 was obtained in the same manner as in example 1 except that the number of corrective rollers and the tension of a base wire at a corrective unit were as follows.
The number of corrective rollers: 18
Tension of base wire at corrective unit:
[Evaluation]
The average value and the standard deviation of the cross-section hardnesses were measured in the above-described method. The tensile strength and the straightness of each core were measured in the above-described method. Furthermore, the fatigue value of each core was measured. The fatigue value was measured by using a Hunter fatigue tester manufactured by BEKAERT. When a test stress was 1000 to 1500 MPa in the atmosphere in which the humidity was 40%, a stress at which all of five test samples reached a fatigue limit of 107 was set as a fatigue value. The results are indicated below in Table 1.
The evaluation results in Table 1 clearly indicate that the present invention is superior.
The wire according to the present invention is applicable to various medical treatment instruments.
Number | Date | Country | Kind |
---|---|---|---|
2017-140985 | Jul 2017 | JP | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/JP2018/024237 | 6/26/2018 | WO | 00 |