JP4136370B2 - Method for producing core material for medical guide wire and medical guide wire - Google Patents

Description

【００３１】
表１から明らかなように、本発明の製造方法によって製造した医療用ガイドワイヤ芯線は、全て要求される接合強度を満たしていることがわかる。
【００３２】
【発明の効果】
本発明によれば、形態順応性を備えた挿入部材とトルク伝達性を備えた導入部材とを、容易にかつ安価に製造できるとともに、挿入部材および導入部材の切削段部端面と管状接合部材の両端でも溶接されるので、接合強度をさらに向上させることができる。
【図面の簡単な説明】
【図１】本発明の製造方法を説明する概略断面図である。
【図２】従来の医療用ガイドワイヤの断面図である。
【符号の説明】
１ 挿入部材
２ 導入部材
１ａ、２ａ 接合部
３ 管状接合部材[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a core material for a medical guide wire used to guide a thin tubular catheter introduced into a blood vessel, digestive tract, trachea, or other body cavity (hereinafter referred to as a treatment-needed tube) that requires treatment or examination. Hereinafter, the present invention also relates to a manufacturing method of a core material) and a medical guide wire (hereinafter also referred to as a guide wire) using the core material manufactured by the manufacturing method.
[0002]
[Prior art]
There are various guide wire structures depending on the application. Generally, as shown in FIG. 2 (a), a core material 10 having a predetermined length is coated with a synthetic resin 11; As shown in FIG. 2 (b), there is one in which a core material 12 having a predetermined length is encapsulated with a coil spring 13. As shown in FIGS. 2 (a) and 2 (b), the cores 10 and 12 are tapered so that the insertion portions 10a and 12a gradually decrease in cross-sectional area in order to give flexibility to the insertion portion as a guide wire. Is formed.
[0003]
Conventionally, a stainless steel wire or a piano wire has been used as the core material. However, the guide wire using this type of core material has a problem that it is difficult to apply to a branching blood vessel or the like that meanders in a complicated manner even if the tip portion is tapered.
[0004]
Therefore, as a core material, (1) a guide wire using a Ti—Ni—Fe alloy (for example, Japanese Patent Publication No. 4-2273), (2) a Ti—Ni alloy, which is a superelastic alloy, is used. Guide wires (for example, Japanese Patent Publication No. 4-8065), (3) guide wires using a Co—Ni—Cr—Fe alloy (for example, Japanese Patent Laid-Open No. 6-63151), and the like have been proposed.
[0005]
Here, the superelasticity is described in JP-A-6-63151, column 1, line 50 to column 2, line 7, and the recoverable elastic strain is from several% to several tens%. It means that the load is not changed even if the strain increases.
[0006]
The core material made of the above superelastic alloy is flexible and has a resilience to deformation to a considerable extent (approximately 8% strain). Therefore, it is difficult to bend during hand operation and difficult to bend. It has the advantages such as.
[0007]
By the way, an important performance as a guide wire is that it can be smoothly inserted into a treatment-needed tube by a hand operation, and a catheter can be guided and introduced accurately to a target site. For this reason, the core material used for the guide wire has a form adaptability that can be inserted without damaging the inner wall of the treatment tube, corresponding to the treatment tube where the insertion portion meanders in a complicated manner, and the introduction portion that follows this However, it is required to have a torque transmission property that accurately transmits even a delicate operation amount at hand to the insertion portion.
[0008]
And today, in order to be applicable to complex branch blood vessels according to the development of medical technology, the core material of the guide wire has the conformability of the insertion part and the torque transmission of the introduction part, There is a demand for further improvement.
[0009]
However, the guide wire using the core materials of the above (1) and (3) is super elastic and has sufficient shape adaptability as a whole because the core material is made of a super elastic single material. However, since the transmittable torque and the torsional rigidity are inferior to those of stainless steel wires or piano wires, there is a difficulty in the torque transmission performance of the introduction portion.
[0010]
In addition, the guide wire using the core material of (2) above gives form insertion flexibility by changing the heat treatment conditions of the core insertion portion and the introduction portion made of a single superelastic alloy material. However, although torque transmission is imparted to the introduction portion, since heat treatment is performed using an expensive superelastic alloy, the material cost and the processing cost increase, and the manufacturing cost increases.
[0011]
As a means for solving the above problem, a guide wire has been proposed in which a wire having shape conformability and a wire having torque transmission are joined by a tubular joining member. For example, in Japanese Patent Laid-Open No. 4-9162, the inner diameter of an annular joining member (tubular joining member) is the outer diameter of the tip of a first filament (insertion member) and the second filament (introduction member). The shape having an inner diameter slightly smaller than the outer diameter of the rear end portion is memorized, and after the inner diameter is enlarged by forcibly expanding the inner diameter, it is fitted to the joint portion of the above-mentioned linear body, and A guide wire has been proposed in which both filaments are fixed by restoring to a memorized shape by heating or cooling to a predetermined temperature.
In Japanese Patent Laid-Open No. 11-57014, a metal thin film having a thickness of 1 to 10 μm is deposited on the rear end portion of the first wire (insertion member), which is gradually reduced in diameter toward the tip. This metal thin film is used as a bonding aid for brazing by brazing filled between the inner surface of the bonding member and the outer surface (the brazing space). A guide wire that is fixed in place is proposed.
[0012]
[Problems to be solved by the invention]
However, the former guide wire is manufactured by forcibly expanding the inner diameter of the tubular joining member, and the inner diameter of the tubular joining member is as small as about 0.3 mm. Expanding the diameter requires time and skill, and an increase in cost is inevitable.
The latter guide wire is manufactured by forming a metal film on the surface by a vapor deposition method, an ion plating method, or the like, and an apparatus for forming a metal film such as a vapor deposition device or an ion plating device is expensive. In addition, it takes a long time to form a metal film with a thickness of several microns by these apparatuses, and brazing takes a long time, so that the manufacturing time per one is long and the manufacturing cost increases. Had a problem.
[0013]
The present invention has been made in view of the above-described problems of the prior art, and an object of the present invention is to manufacture an insertion member having a form conformability and an introduction member having torque transmission properties, which are different in chemical composition, from a manufacturing cost. It is an object of the present invention to provide a manufacturing method capable of easily joining while suppressing an increase in the temperature.
[0014]
[Means for Solving the Problems]
In order to achieve the above object, a method for manufacturing a core material for a medical guide wire according to the present invention includes an insertion member made of a Ni-Ti alloy having a different form and conformity, and a torque transmission property. A method for producing a core material for a medical guide wire, in which a lead member made of stainless steel or a Co-Ni-Cr-Fe alloy is integrally joined with a tubular connecting member made of Ni or a Ni alloy. , and diameter reduction by cutting the joint portion of the insertion member and the introduction member, after insertion of the joint to the tubular connecting member, the junction point between the introduction member of the tubular connecting member junction is inserted in the insertion member It is characterized in that the insertion member, the introduction member, and the tubular connection member are welded by separately irradiating the portion of the tubular connection member into which the tube is inserted .
[0015]
According to the production method of the present invention, each member is reduced in diameter by a relatively easy cutting process, and only the reduced-diameter joining portion is inserted into the tubular joining member, so time and skill are not required, Expensive equipment is also unnecessary. Moreover, since the joining means is a laser, the joining can be completed in an extremely short time.
[0016]
Here, morphological adaptability means a characteristic that can be easily inserted into a complex branch blood vessel without damaging the inner wall, and torque transferability means that a delicate operation amount is accurately applied to the distal end portion (insertion portion). Specifically, the insertion portion is made of a wire material of Ti-Ni alloy, Cu-Al-Ni alloy or Co-Ni-Cr-Fe alloy, and the introduction portion is It is preferable to use a wire rod made of stainless steel or Co—Ni—Cr—Fe alloy.
[0017]
The material of the tubular joining member is most preferably Ni or a Ni-based alloy in consideration of the affinity between the insertion member and the introduction member.
[0018]
The joining means of each joining portion of the insertion member and the introducing member and the tubular joining member has the property that the monochromaticity and directivity are better than those of ordinary light, the phases are aligned, and the light collecting property is very good. Laser welding using laser light is most preferable, but electron beam welding using an electron beam can also be used.
Further, the laser beam or the electron beam may be irradiated to the entire tubular joint member, but if the portion where the joint portion of the insertion member is inserted and the portion where the joint portion of the introduction member is inserted are separately irradiated. The welding is more reliable and preferable.
[0019]
A medical guide wire can be formed by coating the core material with a synthetic resin, a composite material, or the like, or encapsulating with a coil spring.
[0020]
DETAILED DESCRIPTION OF THE INVENTION
Embodiments of the present invention will be described with reference to the drawings.
[0021]
FIG. 1 is a schematic cross-sectional view for explaining the manufacturing method of the present invention. The insertion member 1 and the introduction member 2 are formed by processing the joints 1a and 2a to a small diameter with a lathe or the like, and these joints 1a and 2a are formed into a tubular joint member 3. The state which is inserted and irradiated with the laser beam A to the tubular joining member is shown.
[0022]
The insertion member 1 and the introduction member 2 are such that the elastic limit (form conformability) of the insertion member 1 is larger than the elastic limit of the introduction member 2, and the torsional rigidity (torque transmission property) of the introduction member 2 is greater than the torsional rigidity of the insertion member 1. It is comprised with the wire material from which a chemical composition differs so that the relationship which becomes large may be satisfy | filled. The wire diameter is about 0.2 to 0.7 mm.
[0023]
Although the length of a tubular joining member is not specifically limited, About 2-5 mm is preferable. This is because if the thickness is less than 2 mm, the welded portion becomes too small to obtain the joint strength, and if it exceeds 5 mm, the flexibility of the portion is extremely lowered and it is supported for smooth insertion into the treatment tube. Because it brings
[0024]
The diameter of each joint is preferably 1/3 to 2/3 of the wire diameter of the insertion member and the introduction member, and the fit is preferably 0.02 to 0.05 mm. Moreover, it is preferable that the outer diameter of the tubular joining member is approximately equal to or smaller than the wire diameter of the insertion member and the introduction member.
The reason why the diameter of the joint is 1/3 to 2/3 is that if it is less than 1/3, it becomes too thin and cutting becomes difficult or the strength is lowered. The inner diameter of the tubular joint member becomes larger, the wall thickness becomes thinner, making it difficult to manufacture the tubular joint member itself, or the outer diameter of the tubular joint member becomes too large to provide support for smooth insertion into a treatment tube requiring treatment. Because it becomes.
Further, the fit is 0.02 to 0.05 mm because if it is less than 0.02 mm, it is difficult to insert each member into the tubular joining member, and if it exceeds 0.05 mm, the gap becomes too large and the joining strength is increased. It is because it falls.
Furthermore, the outer diameter of the tubular joint member is set so that the wire diameters of the insertion member and the introduction member are approximately equal or smaller. If the diameter is large, the joint portion has a convex shape, which supports smooth insertion into the treatment-needed tube. Because it comes.
[0025]
Furthermore, the length of each joint is preferably 1/3 to 1/2 of the length of the tubular joint member. This is because if the ratio exceeds 1/2, a gap is generated between each member and the tubular joining member, and the characteristics of this portion are deteriorated. When it is smaller than 1/2, the end face of the joint portion does not contact, but since there is welding between the insertion member and the tubular joint member, and the introduction member and the tubular joint member, there is no problem in strength. However, from the viewpoint of the strength of the joint, the length of the joint must be 1/3 or more.
[0026]
According to the manufacturing method of the present invention, in addition to the joining between the joining portion and the tubular joining member, the cutting step end face of the insertion member and the introduction member and the both ends of the tubular joining member are also welded, so that the joining strength is further improved. be able to.
[0027]
A medical guide wire using the core material manufactured by the manufacturing method of the present invention is obtained by covering the entire core material for medical guide wire with a synthetic resin or by covering only the insertion portion with a synthetic resin. Can do. As the synthetic resin, known materials such as polyethylene, polyester, polypropylene, polyurethane, and silicone rubber can be used.
[0028]
【Example】
Examples of the present invention will be described below.
First, an introduction member having a SUS304 composition and a wire diameter of 0.30 mm and an insert member having a wire diameter of 0.30 mm made of a Ti—Ni alloy composed of 51% Ni and the balance being Ti are manufactured. Was cut to a diameter of 0.15 mm with a lathe. Then, the cutting portions (joining portions) of the respective wire rods were inserted into a Ni tubular joining member having a length of 3.0 mm so that the ends of the two wire rods face each other at substantially the center. The length of each joining portion is 1.4 mm, and the inner diameter of the tubular joining member is 0.18 mm. The joining portion was irradiated with laser to weld the insertion member, the introduction member, and the tubular joining member.
[0029]
And five core wires for guide wires were manufactured as mentioned above, and each joint strength was measured with the tensile testing machine. The results are shown in Table 1. The wire diameter for calculating the joining strength was used by measuring the diameter of the tubular joining member (welded part) with a micrometer. If the bonding strength is 500 MPa or more, there is no problem in use.
[0030]
[Table 1]

[0031]
As can be seen from Table 1, all the medical guide wire core wires manufactured by the manufacturing method of the present invention satisfy the required bonding strength.
[0032]
【The invention's effect】
ADVANTAGE OF THE INVENTION According to this invention, while being able to manufacture the insertion member provided with form adaptability and the introduction member provided with torque transmission easily and cheaply, the cutting step part end surface of an insertion member and an introduction member, and a tubular joining member Since both ends are also welded, the joint strength can be further improved.
[Brief description of the drawings]
FIG. 1 is a schematic cross-sectional view illustrating a production method of the present invention.
FIG. 2 is a cross-sectional view of a conventional medical guide wire.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Insertion member 2 Introduction member 1a, 2a Joining part 3 Tubular joining member

Claims (2)

An insert member made of a Ni-Ti alloy having a conformability and having a different chemical composition, and an introduction member made of stainless steel or a Co-Ni-Cr-Fe alloy having torque transmission properties are made of Ni or Ni. A medical guide wire core material integrally joined with a tubular connecting member made of a base alloy, wherein the joint portion of the insertion member and the introduction member is reduced in diameter by cutting, and the joint portion is After inserting into the tubular connection member, the insertion member and the introduction member are separately irradiated with laser at the location of the tubular connection member where the joint portion of the insertion member is inserted and the location of the tubular connection member where the joint portion of the introduction member is inserted. And a tubular connecting member are welded to each other, and a method for manufacturing a medical guide wire core material. A medical guide wire using a core material manufactured by the method for manufacturing a core material for medical guide wire according to claim 1 .

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