JP5139184B2 - Method for manufacturing medical device and medical device - Google Patents

Description

  The present invention relates to a method for manufacturing a medical device and a medical device.

Conventionally, in medical instruments having linear portions, such as basket forceps and wire-type high-frequency knives, linear members having various shapes are formed by plastic processing of metal wires, and linear members or The linear part was formed by joining a linear member and other components.
For example, in Patent Document 1, a plurality of elastic wires bent into a mountain-shaped polygonal line by a plurality of bent portions are coupled to one at one end side by a chip as a coupling member, and an operation wire is coupled at the other end side. A calculus crushing device (medical instrument) is described in which a basket-like basket portion is formed at the end portion of the operation wire by being integrally coupled with the end portion.
Further, Patent Document 2 has a plurality of sets formed by arranging a plurality of elastic wires and binding both ends of the front end and the rear end, and each set of elastic wires includes a middle portion from the tip to the base end. A basket-type grasping forceps having a basket portion provided with a plurality of bending points at the same position is described.
The basket portion of Patent Document 2 has four sets of wires configured by arranging two elastic wires, the front end of each wire set is bound by a front end tip, and the rear end of each wire set is operated by a rear end tip. They are bundled together with the tip of the wire and fixed to the tip of the operation wire.
When the basket portion is configured as described above, the elastic wire is restored in its bent shape when the basket portion is expanded, and the elastic wire is made of, for example, stainless steel in order to ensure the strength to crush stones and the like when the basket portion contracts. It has been common to form a bendable shape that can be restored by using a stranded wire using a metal wire such as a plastic wire and plastic processing the wire.
Japanese Patent Publication No. 3-21183 Japanese Patent No. 3075355

However, the conventional methods for manufacturing medical devices and medical devices as described above have the following problems.
When plastic processing is performed on a metal wire, for example, slip occurs at a grain boundary in a plastic processed portion such as a bent portion, and fatigue failure is likely to occur when repeated stress is applied. In addition, it is brittle due to work hardening. Therefore, there exists a problem that intensity | strength falls compared with the wire before plastic processing, and durability will be inferior.
Further, since a residual stress is generated in the bent portion of the wire along with the plastic working, there is a problem that it is difficult to maintain the shape when the residual stress is released. In particular, there is a possibility of destruction at a complicatedly bent portion.
Further, in Patent Documents 1 and 2, since the ends of a plurality of elastic wires are mechanically coupled using a coupling member such as a chip, there is a problem that loosening of coupling tends to occur over time. .
It is conceivable to join elastic wires together with solder, but the bonding strength depends on the wettability and affinity with the wire, so there is a problem that sufficient bonding strength cannot be obtained depending on the type of wire. . In addition, there is a problem that soldering cannot be employed when the wire becomes hot, such as a wire-type high-frequency knife.

  This invention is made | formed in view of the above problems, and it aims at providing the manufacturing method and medical device of a medical device which can improve durability and intensity | strength of a linear part. .

In order to solve the above-described problems, a method for manufacturing a medical device according to the present invention is a method for manufacturing a medical device having a linear portion, and is made of an amorphous alloy having a glass transition region of 20 ° C. or higher. A linear part forming step of forming a linear part constituting a part of the linear part by press-molding the wire in a state of being heated to a temperature range of the glass transition region of the amorphous alloy; and A part-to-be-joined part placement step for placing a part of the line-like part formed by the part-to-be-formed part adjacent to a part to be joined that forms the other part of the line part; After the parts to be joined are arranged by the joining part arrangement step, the parts to be joined and the linear parts are heated in a temperature range of a part of the linear parts to a temperature range of the glass transition region of the amorphous alloy. A part of the linear part while Molded to, a method and a bonding step of bonding the linear component on the object to be bonded part.
According to this invention, by performing the linear part forming step, the bonded component placement step, and the bonding step in this order, the linear component is bonded to the bonded component to form the linear portion of the medical device. be able to.
In the linear part forming process, a wire made of an amorphous alloy having a glass transition region of 20 ° C. or higher is pressed in a state where the temperature is raised to the temperature range of the amorphous alloy glass transition region that can be easily press-formed even at low pressure. Since the molding is performed, the shape of the mold is transferred to the linear part, and the residual stress is relaxed or removed.
In addition, the amorphous alloy has a characteristic that the Young's modulus is small and the tensile strength is large compared to the crystal alloy, and therefore, a linear part of a medical instrument that requires flexibility and strength, for example, a basket of basket forceps Particularly suitable for parts.
Further, in the joining process, the same heating and press molding are performed, so that the adhesion of the linear part to the parts to be joined becomes good, and a high joining strength can be obtained in a state where the residual stress is relaxed or removed. In particular, when the part to be joined is a wire in which a wire is twisted, an amorphous alloy constituting the linear part adheres along the irregularities on the surface of the wire, so that higher joint strength can be obtained.
In addition, in a to-be-joined component arrangement | positioning process, it arrange | positions adjacently shall include the case where it arrange | positions in contact and the case where it adjoins.

Moreover, in the manufacturing method of the medical device of this invention, it is preferable that the glass transition temperature of the said amorphous alloy is 300 degreeC or more.
In this case, since a linear part is formed using an amorphous alloy having a glass transition temperature of 300 ° C. or higher, the linear part does not soften or crystallize and become brittle at a temperature lower than 300 ° C. The shape and strength are stable at a temperature lower than 300 ° C.
Since the continuous use maximum temperature of the resin material generally used for medical instruments is lower than 300 ° C., it can be used for general purposes as a linear portion used with such a resin material. Further, it can be used for a wire type high-frequency knife or the like in which the heat generating portion reaches nearly 300 ° C. (but does not exceed 300 ° C.).

Moreover, in the manufacturing method of the medical device of this invention, it is preferable to press-mold with the pressure of 10 Mpa or more in the said joining process.
In this case, since press molding is performed at a pressure of 10 MPa or more, generally, an amorphous alloy having a glass transition region of 20 ° C. or higher, which is known to easily deform even at a temperature lower than 10 MPa in the glass transition region, is 10 MPa. Compared with the case where press molding is performed at a pressure lower than that, press molding can be performed at a relatively low temperature side away from the crystallization temperature even within the temperature range of the glass transition temperature. For this reason, there is little concern that the amorphous alloy reaches the crystallization temperature during press forming, so that temperature control can be simplified or rapid press forming can be performed.

The medical instrument of the present invention is a medical instrument manufactured by the method for manufacturing a medical instrument according to any one of claims 1 to 3.
According to this invention, there exists an effect similar to the invention in any one of Claims 1-3.

  According to the medical device manufacturing method and the medical device of the present invention, a wire made of an amorphous alloy having a glass transition region of 20 ° C. or higher is press-molded in a state where the temperature is raised to the temperature range of the glass transition region. Since a linear part is formed and a linear part is formed by joining this linear part to a part to be joined by the same press molding, the effect that the durability and strength of the linear part can be improved is achieved. Play.

  Embodiments of the present invention will be described below with reference to the accompanying drawings. In all the drawings, even if the embodiments are different, the same or corresponding members are denoted by the same reference numerals, and common description is omitted.

[First Embodiment]
A medical instrument according to a first embodiment of the present invention will be described.
FIG. 1 is a schematic cross-sectional view showing a schematic configuration of a medical instrument according to the first embodiment of the present invention. FIG. 2 is a perspective view showing a linear portion of the medical instrument according to the first embodiment of the present invention. In addition, since each drawing is a schematic diagram, the dimension ratio and the shape are exaggerated (the following drawings are also the same).

The basket forceps 1 which is a medical instrument of the present embodiment is a treatment tool that captures, collects, and crushes, for example, a calculus or the like, and passes through a treatment tool channel of an endoscope inserted into a body cavity. It can be inserted into a treatment part in a body cavity.
As shown in FIG. 1, the basket forceps 1 has a schematic configuration in which a flexible sheath 4 that can be inserted into a treatment instrument channel of an endoscope, and an operation wire 3 that is inserted into the flexible sheath 4 so as to advance and retreat ( A linear part to be joined) and the distal end of the operation wire 3, and is provided inside the hard portion 5 provided at one end of the flexible sheath 4 so as to be movable back and forth in the axial direction of the flexible sheath 4. A basket portion 2 and a base portion 6 for inserting a rod-like coupling member 7 joined to the other end of the flexible sheath 4 and joined to the rear end portion of the operation wire 3 so as to advance and retreat are provided.

As the configuration of the flexible sheath 4, for example, a metal close-wound coil having a liquid-tight tube provided on the inner peripheral surface, a flexible resin sheath, or the like can be employed.
As the material of the operation wire 3, for example, a stranded wire formed by twisting a metal wire such as a stainless wire can be employed.

The base part 6 is inserted through the other end part of the flexible sheath 4 into one end part of the base body 6e having a guide hole 6c provided through the center part for guiding the advancement and retraction of the coupling member 7. A cover 8 that protects the other end of the flexible sheath 4 and a sheath joint 6d that joins the other end of the flexible sheath 4 within the cover 8 are provided.
The other end of the base body 6e is provided with a connecting portion 6a for connecting to an operating portion (not shown) for operating the basket forceps 1 by moving the operating wire 3 forward and backward.
In addition, a liquid supply port portion 6b for supplying a liquid such as a contrast medium is provided in the middle portion of the base body 6e by connecting a syringe (not shown) or the like from the side.

The basket part 2 grips or crushes an object to be treated such as a calculus, for example. In this embodiment, as shown in FIG. 2, the basket part 2 is bent into a mountain-shaped broken line by bending parts 2i and 2j, respectively. Basket wires 2A, 2B, 2C, and 2D having the same shape are integrally joined to each other at the distal end joining portion 2a and the proximal end joining portion 2b at both ends of the mountain-shaped hem. (Hereinafter, when there is no possibility of misunderstanding, “basket wires 2A, 2B, 2C, 2D” may be collectively referred to as “basket wires 2A etc.”)
The tip joint portion 2a is formed by integrating one end portions of the basket wire 2A and the like into a cylindrical shape. In addition, the base end joint portion 2b is formed by integrating the other end portion of the basket wire 2A or the like on the outer peripheral side of the end portion of the operation wire 3 and integrating them into a columnar shape.
The basket wire 2A and the like are arranged so as to be rotationally symmetric with respect to a central axis C connecting the center lines of the distal end joint portion 2a and the proximal end joint portion 2b. Therefore, the basket wires 2A and 2C are arranged in line symmetry with the central axis C as the symmetry axis on the same plane, and the basket wires 2B and 2D include the central axis C and the plane on which the basket wires 2A and 2C are arranged. They are arranged in line symmetry with the central axis C as the axis of symmetry on an orthogonal plane.

In this way, the basket wires 2A, 2B, 2C, and 2D form a hook-like linear portion centered on the central axis C, and the object to be treated is taken in through the gap between the wires, It is possible to store an object to be treated inside.
In addition, the basket portion 2 constitutes a part of the linear portion of the basket forceps 1 by being joined to the operation wire 3 which is a linear joined component at the proximal end joining portion 2b.

The material of the basket wire 2A and the like is a titanium (Ti) -based alloy (composition: Ti ₄₅ Cu _42.5 Ni _7.5 Zr _2.5 Si _2.5 , crystal Temperature of about 480 ° C., glass transition temperature: about 420 ° C., glass transition region: about 60 ° C.). Hereinafter, the crystallization temperature, the glass transition temperature, and the glass transition region of the Ti-based alloy having this composition are represented by T _x1 , T _g1 , and ΔT ₁ , respectively.
Here, the amorphous alloy is an alloy obtained by solidifying (amorphizing) a plurality of metal elements without forming a crystal structure. The amorphous alloy is formed by rapidly cooling a molten metal raw material composed of a plurality of metal elements until the temperature is equal to or lower than the glass transition temperature. Amorphous alloys do not have the grain boundaries found in ordinary crystalline metals, and do not cause grain boundary corrosion (a phenomenon in which corrosion progresses along the grain boundaries) due to grain boundaries. Therefore, it has excellent corrosion resistance.
The metal glass in this specification refers to an amorphous alloy having a glass transition region (a value obtained by subtracting the glass transition temperature from the crystallization temperature) of 20 ° C. or higher.
Since metallic glass does not cause solidification shrinkage like crystalline metal, it has high-accuracy transferability to a molding die, and furthermore, hot pressing like glass is possible in the glass transition region. Excellent shape flexibility, dimensional accuracy, and productivity of molded products. In addition, metallic glass has low Young's modulus and high strength as its physical properties, and further has low expansion against heat.
In an amorphous alloy having a glass transition region of less than 20 ° C., since the glass transition region is too narrow, it is difficult to control the molding temperature when performing press molding in the glass transition region. Therefore, in the part exceeding the crystallization temperature which is the upper limit of the glass transition region, the characteristics of high strength and high corrosion resistance unique to the metal glass are lost. Moreover, in a part below the glass transition temperature which is the lower limit of the glass transition region, formability is inferior.
Therefore, it becomes impossible to manufacture a good basket wire 2A or the like or the basket portion 2.

Examples of the metal glass that can be suitably used for the basket wire 2A of the present embodiment include iron (Fe) based alloys, zirconium (Zr) based alloys, magnesium (Mg) based alloys, etc., in addition to Ti based alloys. Can be mentioned.
Further, the metallic glass is easily obtained when the metallic material satisfies the following three conditions (I) to (III), and is not limited to the amorphous alloy.
(I) It contains three or more metal elements.
(II) The three or more metal elements have atomic diameters different by 12% or more. For example, metal elements of three sizes, large, medium and small, have atomic diameters different from each other by 12% or more.
(III) Each metal element is easily compounded. That is, each metal element has a property of attracting each other.

Next, a manufacturing method of the basket forceps 1 will be described focusing on a manufacturing method of a linear portion including the basket portion 2 and the operation wire 3.
FIG. 3 is a front view showing a linear part of the medical instrument according to the first embodiment of the present invention. FIG. 4 is a perspective view for explaining a linear part forming step of the method for manufacturing the medical device according to the first embodiment of the present invention. FIG. 5 is a process explanatory diagram of a bonded part arrangement process in the method for manufacturing a medical device according to the first embodiment of the present invention. 6 (a), 6 (b), and 6 (c) are process explanatory views showing an example of a joining process of the method for manufacturing the medical device according to the first embodiment of the present invention. FIGS. 7A, 7 </ b> B, and 7 </ b> C are process explanatory views illustrating another example of the joining process of the method for manufacturing the medical device according to the first embodiment of the present invention.

The manufacturing method of the medical instrument which concerns on this embodiment is a method which comprises a linear component formation process, a to-be-joined components arrangement | positioning process, and a joining process, and performs these processes in this order.
The linear part forming step is a step of forming a linear part that forms a part of the linear part by press-molding a wire made of metallic glass in a state where the temperature is raised to the temperature range of the glass transition region of the metallic glass. It is.
In this embodiment, the bending wire 20 (linear part) shown in FIG. 3 is formed for use in the basket wires 2A, 2B, 2C, and 2D.
The bending wire 20 is made of the Ti-based alloy, and forms a distal end portion 2c for forming the distal end joint portion 2a, elastic wire portions 2d, 2e, 2f for forming a mountain-shaped broken line shape, and a proximal end joint portion 2b. The base end portion 2g for bending is bent at bent portions 2h, 2i, 2j, and 2k between them in the same plane.
As shown in FIG. 3, the bending shape of the bending wire 20 is such that when the distal end portion 2c is arranged in the illustrated horizontal direction, the elastic wire portion 2d extends obliquely upward from the bending portion 2h formed at one end thereof, The elastic wire portion 2e extends in the horizontal direction in the figure from the bent portion 2i at the end opposite to the bent portion 2h of the elastic wire portion 2d, and the bent portion 2j at the end opposite to the bent portion 2i of the elastic wire portion 2e. The elastic wire portion 2f extends obliquely downward from the figure, and the base end portion 2g extends in the horizontal direction in the figure from the bent portion 2k on the opposite side of the bent portion 2j of the elastic wire portion 2f. .
The proximal end portion 2g is arranged substantially parallel to the distal end portion 2c at a position shifted to the elastic wire portion 2e side by a distance d. The distance d may be 0, but is preferably set to a size approximately equal to the radius of the operation wire 3.

In order to form such a bending wire 20, in this step, first, a wire made of the Ti-based alloy having the same diameter as that of the bending wire 20, for example, a diameter of 0.5 mm is used. Disconnect. Then, the cut wire is subjected to press working at a low temperature not _higher than the glass transition temperature _Tg1, and is bent into a shape substantially the same as that of the bent wire 20 (a wire made of an amorphous alloy, see FIG. 4). ).
At this time, residual stress is generated in the bent portion of the pressed blank wire 11.

Next, the blank wire 11 is press-molded in a state where the temperature is raised to the temperature range of the glass transition region ΔT ₁ , that is, the glass transition temperature T _g1 or higher and lower than the crystallization temperature T _x1 .
In the present embodiment, as shown in FIG. 4, the gold formed by forming a groove 10 a having a semicircular cross section perpendicular to the extending direction corresponding to the bent shape of the bending wire 20 in plan view on the flat portion 10 b. Press molding is performed using the molds 10A and 10B each having the mold surface 10c.

Although not particularly illustrated, the molds 10A and 10B are for temperature control of the temperature of the mold surface 10c to a temperature range of the glass transition region ΔT ₁ , that is, a temperature range of T _g1 = about 420 ° C. to T _x1 = about 480 ° C. The heater part is provided. In addition, the molds 10A and 10B are positioned so that the grooves 10a face each other and move forward and backward in the facing direction, and pressurizing and releasing the pressing of the molds 10A and 10B against the workpiece. Supported by the mechanism.
In the present embodiment, since the glass transition region ΔT ₁ of the blank wire 11 that is the molding is about 60 ° C., the heater unit can control the temperature of the mold surface 10 c without performing highly accurate temperature control. It can be kept in the temperature range of the glass transition region ΔT ₁ . For example, the heater unit can be controlled to about 450 ° C. ± 2 ° C. by controlling on / off of the heater with a constant duty.
However, when the temperature change width can be sufficiently narrow compared with the glass transition region ΔT ₁ , the temperature control of the mold surface 10 c is performed so that the temperature of the mold surface 10 c does not reach the crystallization temperature T _x1. The central value is preferably a temperature closer to the glass transition temperature _Tg1 than the crystallization temperature _Tx1 .

In this step, first, the blank wire 11 is placed in the groove 10a of the mold 10A in a state where the mold temperatures of the molds 10A and 10B are lower than the glass transition temperature _Tg1 by a heater unit (not shown). The mold temperature at this time may be higher than the room temperature as long as the blank wire 11 can be disposed in the groove 10a without hindrance.
The mold 10A, and 10B heated by the heater unit, above the temperature of the glass transition temperature _{T g1} of each mold face 10c, a blank wire 11 disposed in the groove 10a of the mold 10A is a glass transition region from when the temperature range of [Delta] T _1, the mold 10B is lowered, continue to press the blank wire 11.
Since the heat capacity of the blank wire 11 is much smaller than that of the mold 10A, the temperature of the blank wire 11 is increased substantially in synchronization with the temperature increase of the mold 10A. Therefore, in this embodiment, when the mold surface 10c of the mold 10A reaches 450 ° C., the blank wire 11 exceeds the glass transition temperature _Tg1 , and therefore, the temperature of the mold 10A is detected and press molding is performed. You can decide when to start.

The blank wire 11 heated to the temperature range of the glass transition region ΔT ₁ can be easily deformed at a pressure lower than 10 MPa. For this reason, by pressing the molds 10A and 10B so that an appropriate pressure is applied to the blank wire 11, the blank wire 11 is deformed along the shape of each groove 10a of the molds 10A and 10B. The When the pressure is maintained for a certain molding time, the shape of the groove 10 a is transferred to the blank wire 11. Further, the residual stress at the bent portion is also relaxed.
The molding pressure and molding time may be appropriately set according to the material of the metal glass, the shape of the bending wire 20, the degree of residual stress of the blank wire 11, and the like.

After a certain molding time elapses, the heating of the molds 10A and 10B is stopped, and the blank wire 11 is cooled until the temperature becomes lower than the glass transition temperature _Tg1 .
After this cooling, the molds 10A and 10B are opened and the molding is removed, so that the bending wire 20 in which the shape of the groove 10a is transferred and the residual stress is relaxed or removed is obtained.
In this embodiment, a total of four such bending wires 20 corresponding to the basket wires 2A, 2B, 2C, and 2D are press-molded in the same manner as described above.
Thus, the linear part forming process is completed.

Next, a bonded component placement step is performed. This process is a process of arranging a part of the linear part formed by the linear part forming process adjacent to the linear part to be joined constituting the other part of the linear part.
In this embodiment, the four bending wires 20 and the operation wires 3 formed in the linear part forming step are three-dimensionally arranged in the same positional relationship as the basket wires 2A and the like of the basket portion 2 and the operation wires 3, respectively. And the positional relationship is held by the holding jig 30. With respect to this positional relationship, the arrangement positions of the pair of opposing bending wires 20 are shown in FIG.
That is, for example, corresponding to the positional relationship between the basket wires 2 </ b> A and 2 </ b> C of the basket portion 2, the respective distal end portions 2 c of the bending wire 20 are arranged in parallel and adjacent to each other, and each proximal end portion 2 g is disposed at the distal end of the operation wire 3. Are arranged adjacent to each other in parallel to the outer periphery of each. In the direction perpendicular to the paper surface of FIG. 5, the other two bending wires 20 are arranged in the same positional relationship corresponding to the positional relationship between the basket wires 2 </ b> B and 2 </ b> D of the basket portion 2.
Accordingly, as shown in FIG. 6A, the four tip portions 2c are arranged adjacent to each other in a lattice shape in the view A in FIG. 5, and as shown in FIG. 7A in the view B in FIG. In the outer peripheral portion of the operation wire 3, four base end portions 2g are arranged at an equal arrangement pitch in the circumferential direction.

The holding jig 30 includes a holding portion 30 a that holds each bending wire 20 and a holding portion 30 b that holds the operation wire 3.
The holding portion 30a can employ an appropriate mechanism that mechanically clamps and holds at least one of the elastic wire portions 2d, 2e, and 2f of each bending wire 20.
For example, a mechanism that clamps the operation wire 3 in the radial direction of the operation wire 3 in the vicinity of the proximal end portion 2g can be adopted as the holding unit 30b.

As described above, the proximal end portion 2 g which is a part of the bending wire 20 is disposed adjacent to the operation wire 3 constituting the other portion of the linear portion with respect to the bending wire 20. Therefore, the operation wire 3 is a linear joined component that forms the other part of the linear portion with respect to each bending wire 20.
Further, the distal end portion 2 c which is a part of one bending wire 20 is disposed in the basket portion 2 adjacent to the distal end portion 2 c of the other bending wire 20 constituting the other portion of the linear portion. Therefore, these other bending wires 20 are linear parts to be joined that constitute other portions of the linear portion with respect to one bending wire 20.

  In such an arrangement state, it is preferable that the distal end portions 2c and the base end portion 2g and the operation wire 3 are in contact with each other. It suffices if it is in an adjacent state close to.

Next, a joining process is performed. In this process, after the parts to be joined are arranged by the part to be joined arrangement step, the parts to be joined and the linear parts are heated in a state where a part of the linear parts is heated to the temperature range of the amorphous alloy glass transition region. A part of the linear part is press-molded while contacting a part of the linear part, and the linear part is joined to the part to be joined.
In the present embodiment, since a part of the linear part is composed of the distal end portion 2c and the proximal end portion 2g, each is press-molded using separate molds.

In order to join the tip portions 2c, as shown in FIG. 6A, a groove portion 12a for forming a cylindrical shape in a state where the four tip portions 2c are arranged adjacent to each other is formed in the flat portion 12b. Press molding is performed using the molds 12A and 12B each having the mold surface 12c.
Although not shown, the mold 12A, 12B is to temperature control the temperature of the mold surface 12c in the temperature range of the glass transition region [Delta] T _1, comprises a mold 10A, similar to the 10B of the heater unit. In addition, the molds 12A and 12B are positioned such that the molds 12A and 12B face each other and move forward and backward in the facing direction to press and release the molds 12A and 12B against the workpiece. Supported by the mechanism.
This pressurizing mechanism can press the molds 12A and 12B with a pressure of 10 MPa or more.

In the joining process of the tip portion 2c by the molds 12A and 12B, as shown in FIG. 6A, first, the groove portions 12a are opposed to each other with the four tip portions 2c arranged adjacent to each other, and each groove portion 12a has four. The molds 12A and 12B are arranged at positions spaced from the two tip portions 2c. Then, the mold 12A by the heater unit (not shown), 12B and is heated to a temperature range of the glass transition region [Delta] T _1. In this embodiment, the temperature is raised to 450 ° C. as in the linear part forming step.
Next, the molds 12A and 12B are brought close to each other by a pressurizing mechanism (not shown) until the groove portions 12a come into contact with the tip portion 2c, and wait until the temperature of each tip portion 2c exceeds the glass transition temperature _Tg1. Let

Each tip 2c heated to the temperature range of the glass transition region ΔT ₁ can be easily deformed at a pressure lower than 10 MPa, but in this embodiment, it is pressed at 10 MPa or more, for example, 20 MPa, and each tip The shape of each groove 12a is transferred to the portion 2c.
At this time, in this embodiment, since the molds 12A and 12B are pressurized with a pressure of 10 MPa or more, the adhesion and fusion of the interfaces between the tip portions 2c are promoted, and compared with the case of pressing with a pressure smaller than 10 MPa. It can be molded in a shorter time, and higher bonding strength can be obtained.
In this way, each tip 2c is integrated in each groove 12a, and the shape of the cylindrical tip joint 2a is formed (see FIG. 6B).

After a certain molding time elapses, heating of the molds 12A and 12B is stopped, and the tip joint portion 2a is cooled to a temperature lower than the glass transition temperature _Tg1 .
After this cooling, the molds 12A and 12B are opened to remove the tip joint portion 2a (see FIG. 6C).

Further, in order to join each base end portion 2g and the operation wire 3, as shown in FIG. 7A, the base end portions 2g are formed in a columnar shape with the outer periphery of the operation wire 3 being arranged. Press molding is performed using molds 13A and 13B each having a mold surface 13c having a groove 13a formed on the flat surface part 13b.
Although not particularly illustrated, the molds 13A and 13B include the same heater unit and pressurizing mechanism as the molds 12A and 12B.

In the joining step of the base end 2g and the operation wire 3 by the molds 13A and 13B, as shown in FIG. 7A, first, the groove 13a is opposed across the four base end 2g arranged adjacent to each other. At the same time, the molds 13A and 13B are disposed at positions where the respective groove portions 13a are separated from the four base end portions 2g. Then, the mold 13A by the heater unit (not shown), 13B and is heated to a temperature range of the glass transition region [Delta] T _1. In this embodiment, the temperature is raised to 450 ° C. as in the linear part forming step.
Next, the pressurization mechanism (not shown) closes the molds 13A and 13B until each groove 13a comes into contact with the base end 2g, and the temperature of each base end 2g exceeds the glass transition temperature _Tg1 . Wait until

Each base end 2g heated to the temperature range of the glass transition region ΔT ₁ can be easily deformed at a pressure lower than 10 MPa, but in this embodiment, it is pressed at 10 MPa or more, for example, 20 MPa, The shape of each groove 13a is transferred to the base end 2g.
At this time, in this embodiment, since the molds 13A and 13B are pressurized with a pressure of 10 MPa or more, adhesion and fusion at the interface between the adjacent base end portions 2g are promoted, and the pressure is less than 10 MPa. In comparison, the molding can be performed in a shorter time and higher bonding strength can be obtained.
Each base end portion 2g follows the shape of the groove 13a on the outer peripheral side, and is pressed against the outer peripheral surface of the operation wire 3 on the inner peripheral side, and closely adheres to the uneven shape of the outer peripheral wire of the operation wire 3. And since metal mold | die 13A, 13B is pressurized by the pressure of 10 Mpa or more, the adhesiveness of 2 g of base end parts and the outer peripheral surface of the operation wire 3 also becomes favorable.
Thus, in each groove part 13a, each base end part 2g is integrated, and the shape of the base end joined part 2b which the outer periphery of the operation wire 3 was surrounded cylindrically and the external shape was made into the column shape is formed. (See FIG. 7B).

After a certain molding time elapses, the heating of the molds 13A and 13B is stopped, and the base end joint portion 2b is cooled to a temperature lower than the glass transition temperature _Tg1 .
After this cooling, the molds 13A and 13B are opened, and the proximal end joint portion 2b is removed (see FIG. 7C).
With the above, the joining step is completed, and a linear portion of the basket forceps 1 in which the basket portion 2 is joined to the tip of the operation wire 3 as shown in FIG. 2 is formed.

In order to assemble the basket forceps 1 using this linear portion, first, the coupling member 7 is joined to the end of the operation wire 3 opposite to the side where the basket portion 2 is joined. Then, the coupling member 7 and the operation wire 3 are inserted into the tube of the flexible sheath 4. Next, in a state where the coupling member 7 is inserted into the guide hole 6c of the base part 6, the flexible sheath 4 and the base part 6 are joined by the sheath joining part 6d, and the cover 8 is attached.
Thus, the basket forceps 1 which is a medical instrument having a linear portion is manufactured.

Next, the operation of the basket forceps 1 will be described focusing on the operation of the basket portion 2.
In the basket forceps 1, the connecting portion 6a of the base portion 6 is connected to an operating portion (not shown), and the distal end position of the connecting member 7 protruding from the base portion 6 by the operating portion is retracted close to the connecting portion 6a. It is advanced and retracted between the position and the advance position away from the connecting portion 6a.
When the coupling member 7 is in the retracted position, as shown in FIG. 1, the basket portion 2 is in contact with the hard portion 5 on the base end joint portion 2b side, and the basket portion 2 is expanded in a bowl shape. . For this reason, for example, stones can be taken in from the gap between the basket wires 2A and the like.
Further, when the coupling member 7 is in the advanced position, the operation wire 3 in the flexible sheath 4 is pulled toward the base portion 6 side, and the proximal end joint portion 2b is further pulled toward the flexible sheath 4 side. Thereby, each elastic wire part 2f of the basket part 2 is drawn into the flexible sheath 4 along the inner diameter of the hard part 5, and the basket part 2 is contracted. For this reason, the captured calculus can be held or crushed according to the amount of contraction.

When the basket portion 2 is contracted, the basket wire 2A and the like of the basket portion 2 are stretched by a tensile stress, and the bent portions 2h, 2i, 2j, and 2k are also deformed so that the bent angles are further opened. However, it will be extended.
In the present embodiment, since the basket portion 2 is formed of a metallic glass having a low Young's modulus and a high strength, the basket portion 2 can be smoothly held in accordance with the shape of the calculus and can be crushed with a high load according to the strength. .
Further, since the basket portion 2 is formed by pressing metal glass in a state heated to the temperature range of the glass transition region, the residual stress at the bent portion is relaxed or removed. For this reason, the basket portion 2 is significantly less affected by the residual stress than a wire made of a crystalline metal or a crystalline alloy that is formed in a state where a high residual stress is generated in the bent portion by plastic working. And durability is improved.

Moreover, the basket part 2 forms the front-end | tip joined part 2a and the base end joined part 2b by using press molding in the temperature range of the glass transition area | region in metal glass, without using other joining members, such as a joining chip. The bending wires 20 are bonded to each other, and the bending wire 20 and the operation wire 3 are joined.
For this reason, compared with the case where it joins using another joining member, the number of parts is reduced.
Moreover, the front-end | tip junction part 2a is a junction part of the same material, for example, compared with the joining containing the heterogeneous part of material by soldering, welding, etc., it is a joint part excellent in intensity | strength, corrosion resistance, etc. Can be formed.
In addition, the proximal end joint portion 2b is formed by joining the outer circumference of the operation wire 3 by joining the same material in the circumferential direction, and well following the irregularities on the surface of the operation wire 3, in a state of a metallic glass layer. Therefore, the operation wire 3 can be firmly joined.
In addition, since the tip joint portion 2a and the base end joint portion 2b are cooled after being press-molded in a state where the temperature is raised to the temperature range of the glass transition region, the residual stress is relaxed or removed. Yes, it is possible to reduce or prevent a decrease in strength due to the influence of residual stress.

[Second Embodiment]
A medical instrument according to a second embodiment of the present invention will be described.
FIG. 8 is a schematic partial cross-sectional view showing a schematic configuration of a medical instrument according to the second embodiment of the present invention. FIG. 9 is a partial front view showing a linear part of a medical instrument according to the second embodiment of the present invention.

The high-frequency knife 16 that is a medical instrument according to the present embodiment is an example of a so-called wire-type high-frequency knife. A high-frequency current is applied to a metal wire to cause a resistor such as a biological tissue to generate Joule heat, thereby excising the biological tissue. It is the treatment tool which performs.
As shown in FIG. 8, the schematic configuration of the high-frequency knife 16 includes a lumen 17 having a hollow portion 17a and a distal end portion bent in a V shape, and a distal end side and a proximal end side with the bent portion of the lumen 17 interposed therebetween. A wire knife part 21 (linearly joined part) that is inserted through the provided holes 17b and 17c and partially stretched outside the lumen 17, and a wire knife part 21 that is inserted through the hole 17b. One end of the wire 17 is fixed at a fixed position in the hollow portion 17 a of the lumen 17, and the other end of the wire knife portion 21 inserted through the hole 17 c is covered and held on the outer peripheral side of the lumen 17. The resin cover 18 is provided.
A cap portion 17d is fitted at the tip of the lumen 17 at a position covering the joint portion 19A where the joining wire 19 and the wire knife portion 21 are joined.
The other end of the wire knife portion 21 is inserted into a pipe line (not shown) that maintains electrical insulation with the bonding wire 19 inserted through the lumen 17, and extends to the proximal end side of the lumen 17. .
In the high-frequency knife 16, the wire knife part 21 and the bonding wire 19 constitute a linear part.

  The material of the lumen 17 and the resin cover 18 is made of a synthetic resin excellent in heat resistance and chemical resistance, such as polytetrafluoroethylene (PTFE) or tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA). can do. Since these fluororesins have a melting point exceeding 300 ° C. and a continuous maximum use temperature of about 260 ° C., the temperature may instantaneously rise to nearly 300 ° C. (but not exceeding 300 ° C.). It is suitable for the use of the possible high frequency knife 16.

  The wire knife portion 21 is a conductive material that flows a high-frequency current and comes into contact with the living tissue. For example, a stranded wire using a stainless wire such as SUS304 can be used. The other end of the wire knife portion 21 is connected to a high-frequency power source (not shown) on the proximal end side of the lumen 17.

As shown in FIG. 9, the shape of the joining wire 19 has a width h slightly larger than the inner diameter of the lumen 17 to be engaged with the inside of the distal end portion 19 a that joins one end of the wire knife portion 21 and the distal end portion of the lumen 17. It consists of a bent portion 19b bent in a zigzag manner and a flexible portion 19c extended from the bent portion 19b to the other end side.
The bonding wire 19 is made of a Zr-based alloy (composition: Zr ₅₅ Cu ₃₀ Al ₁₀ Ni ₅ , crystallization temperature: about 490 ° C., glass transition temperature: about 400 ° C., which is classified into metallic glass among amorphous alloys. Glass transition region: about 90 ° C., specific electric resistance 240 μΩ · cm). Hereinafter, the crystallization temperature, the glass transition temperature, and the glass transition region of the Zr-based alloy having this composition are represented by T _x2 , T _g2 , and ΔT ₂ , respectively.

In addition to the Zr-based alloy, the bonding wire 19 may employ a Ti-based alloy, an Fe-based alloy, an Mg-based alloy, or the like, as in the first embodiment. However, the bonding wire 19 is preferably made of a material having a small specific electric resistance because a high-frequency current is applied.
As an example of such another metallic glass exhibiting good conductivity, a wire material made of Fe-based alloy whose constituent element is Co—Fe—Cr—Si—B, Volfa (registered trademark) DE-10 (trade name; Unitika) Can be mentioned). The specific electrical resistance of Volfa (registered trademark) DE-10 is 140 μΩ · cm.

Next, the manufacturing method of the high frequency knife 16 is demonstrated centering on the manufacturing method of a linear part.
Fig.10 (a) is process explanatory drawing of the front view of the to-be-joined components arrangement | positioning process of the manufacturing method of the medical device which concerns on the 2nd Embodiment of this invention. FIG. 10B is a side view as viewed from the side D in FIG. FIG. 11A is a partially enlarged view of a portion C in FIG. FIG. 11B is a side view as viewed from E in FIG.

  The manufacturing method of the medical instrument which concerns on this embodiment is a method which comprises a linear component formation process, a to-be-joined components arrangement | positioning process, and a joining process, and performs these processes in this order. Since these steps are essentially the same as those in the first embodiment, the following description will focus on differences from the first embodiment.

First, in order to form the bonding wire 19, a linear part forming process is performed. That is, in order to form a zigzag bent shape substantially similar to the bent portion 19b so that the straight wire of the Zr-based alloy can be used as a blank wire and the tip of the blank wire can be placed in a mold (not shown), Press processing is performed at a temperature lower than the glass transition temperature _Tg2 .
Then, placed in a mold (not shown), the temperature range of [Delta] T ₂ the ends of the blank wire from the glass transition region, i.e., T _g2 above, perform press molding while heating to a temperature range below T _x2. In this embodiment, the temperature is raised to 450 ° C.
This linear component forming step can be performed in substantially the same manner as the linear component forming step of the first embodiment, except that the shape of the mold surface of the mold used is different.
By this step, since the residual stress generated in the bent portion when the blank wire is pressed at a low temperature is relieved or removed by press molding at the time of temperature rise, a high-strength bonding wire 19 is obtained.

  Next, in the joined component arranging step, as shown in FIGS. 10A and 10B, the tip 19a of the joining wire 19 and one end of the wire knife 21 are connected using a holding jig (not shown). And arranged adjacent to each other in the radial direction.

Next, in the bonding step, the bonding portion 19A is formed in the same manner as the proximal end bonding portion 2b is formed in the first embodiment.
As shown in FIGS. 11A and 11B, the joining portion 19A of the present embodiment surrounds the wire knife portion 21 disposed adjacent to the Zr-based alloy constituting the tip portion 19a in the circumferential direction. And the outer shape is cylindrical.
For this reason, in this embodiment, it replaces with metal mold | die 13A, 13B of the said 1st Embodiment, and uses metal mold | die 31A, 31B shown to Fig.10 (a), (b). Each of the molds 31A and 31B has a mold surface 31c in which a groove part 31a matched to the shape of the joint part 19A is formed on the flat surface part 31b, respectively, and a heater part and a pressurizing mechanism similar to the molds 13A and 13B. Is provided.

In this step, as shown in FIGS. 10 (a) and 10 (b), first, the groove portion 31a is opposed to the adjacent tip portion 19a and the end portion of the wire knife portion 21 sandwiched in the adjacent direction. The dies 31 </ b> A and 31 </ b> B are disposed at a position where each groove 31 a is separated from the end 19 a and the end of the wire knife 21. Then, heated die 31A, and 31B to the temperature range of the glass transition region [Delta] T ₂ by the heater unit (not shown). In the present embodiment, the temperature is raised to 450 ° C. as in the linear part forming step.
Next, the molds 31A and 31B are stopped by a pressurizing mechanism (not shown) until each groove 31a contacts the tip 19a and the end of the wire knife 21, and the temperature of the tip 19a changes to a glass transition. Wait until temperature _Tg2 is exceeded.
Then, for example, pressing is performed at 20 MPa, the tip portion 19a is deformed, and the shape of each groove portion 31a is transferred.
As a result, the tip 19a follows the shape of the groove 31a on the outer peripheral side, and is pressed against the outer peripheral surface of the wire knife 21 on the inner peripheral side, and closely adheres to the uneven shape of the wire on the outer periphery of the wire knife 21. . Since the molds 31A and 31B are pressurized with a pressure of 10 MPa or more, the adhesion between the deformed tip 19a and the outer peripheral surface of the wire knife 21 is also good.
Thus, in each groove part 31a, the front-end | tip part 19a deform | transforms and the shape of the junction part 19A in which the outer periphery of the edge part of the wire knife part 21 was surrounded cylindrically and the external shape was made into the column shape is formed. (Refer FIG.11 (b)).

After the elapse of a certain molding time, the heating of the molds 31A and 31B is stopped, and the joint 19A is cooled until the temperature becomes lower than the glass transition temperature _Tg2 .
After this cooling, the molds 31A and 31B are opened to remove the joint 19A.
Thus, the joining process is completed, and the linear portion of the high-frequency knife 16 is formed.

In order to assemble the high-frequency knife 16 using this linear portion, the wire knife portion 21 is inserted from the hollow portion 17a to the outside through the hole 17b with the cap portion 17d of the lumen 17 removed, and the bonding wire 19 The flexible portion 19 c is inserted through the hollow portion 17 a of the lumen 17. Then, the bent portion 19b is press-fitted into the lumen 17, and the joint portion 19A is positioned at a predetermined position in the vicinity of the hole portion 17b.
Then, the cap portion 17d is fitted from the end portion and joined to the lumen 17 body.
Thereafter, or in parallel with the above, the other end of the wire knife portion 21 is inserted into the hole portion 17 c and fixed to the outer peripheral portion of the lumen 17 by the resin cover 18.
Thus, the high frequency knife 16 which is a medical instrument having a linear portion is manufactured.

According to the high-frequency knife 16 having such a configuration, since the wire portion is formed by bonding the bonding wire 19 and the wire knife portion 21 which are conductive wires, the respective ends are connected to a high-frequency power source to thereby generate a high-frequency current. , The treatment portion can be cut by Joule heat generated by pressing the wire knife portion 21 against the living tissue of the treatment portion of the patient that is in contact with the grounded metal plate.
At this time, with the generated Joule heat, the wire knife part 21 generally does not exceed 300 ° C. even if it is instantaneous. Therefore, the temperature of the joint part 19A is the glass transition temperature even during application of high-frequency current. _Tg2 is not exceeded. Therefore, a stable joined state can be maintained.
Further, since the joint portion 19A is cooled after the front end portion 19a is press-formed in a temperature range of the glass transition region, the residual stress is relaxed or removed, and is affected by the influence of the residual stress. Strength reduction can be reduced or prevented.

Moreover, in the joining part 19A, the wire knife part 21 and the joining wire 19 are joined without using another joining member, so that the number of parts is reduced as compared with the case where other joining parts are used. The lumen 17 of the high-frequency knife 16 has a tube inner diameter of, for example, about 1.5 mm in many cases. However, since no other joining member is used, the joining portion 19A can be easily reduced in size. It is suitable for arrangement in a narrow space such as the inside.

  In addition, when the lumen inner diameter of the lumen 17 is such a small diameter, the radius of curvature of the bent portion 19b of the bonding wire 19 is also reduced, but the bent portion 19b of the present embodiment is in a temperature range of the glass transition region. In this state, the residual stress is relaxed or removed because it is cooled after being pressed. For this reason, since the influence of residual stress is reduced or eliminated as compared with the case where the crystalline metal is pressed to the same radius of curvature, the wire knife 21 cuts the treatment portion via the joint portion 19A. Even if a load is repeatedly applied to the bent portion 19b, and even when the flexible portion 19c is bent by the bending of the wire knife portion 21, excellent durability is provided.

Next, a modification of this embodiment will be described.
FIG. 12 is a schematic partial cross-sectional view showing a schematic configuration of a medical instrument according to a modification of the second embodiment of the present invention. Fig.13 (a) is a top view which shows the linear component of the medical device which concerns on the modification of the 2nd Embodiment of this invention. FIG.13 (b) is F view in FIG.13 (a).

  As shown in FIG. 12, the high-frequency knife 22 (medical instrument) of the present modified example joins the wire knife 21 of the high-frequency knife 16 of the second embodiment to a bonding wire 23 having a shape different from that of the bonding wire 19. It is a thing. Therefore, instead of the lumen 17 and the bonding wire 19 of the second embodiment, a lumen 24 and a bonding wire 23 are provided. Hereinafter, the description will focus on the points different from the above.

  The lumen 24 is a flexible cylindrical body having a first tube portion 24a and a second tube portion 24b extending in parallel with each other, and a wire knife is provided on the side of the first tube portion 24a. Holes 24c and 24d are provided for allowing the portion 21 to be inserted into the first tube portion 24a from the outside.

The joining wire 23 surrounds the end portion of the wire knife portion 21 in the circumferential direction, and is slightly larger than the inner diameter of the first tube portion 24a, thereby being locked inside the first tube portion 24a. It is joined to the wire knife part 21 by the joined part 23a, and is arranged extending in the first tube part 24a to the proximal end side. Therefore, since the joining wire 23 does not have the bending part 19b like the joining wire 19 of the said 2nd Embodiment in order to latch inside the lumen | rumen 24, the joining part 23a is a function of the bending part 19b. Have both.
The material of the bonding wire 23 can be the same material as the bonding wire 19.

The wire knife portion 21 that is exposed to the outside from the hole portion 24c is inserted into the first tube portion 24a through the hole portion 24d, and in the state parallel to the bonding wire 23, the inside of the first tube portion 24a is set to the proximal end side. It is extended and arranged. The wire knife portion 21 of this modification is covered with an insulating coating 25 made of heat-resistant resin at the outer side in the vicinity of the hole portion 24d and at the portion inserted from the hole portion 24d.
The bonding wire 23 and the wire knife part 21 constitute a linear part of the high-frequency knife 22.

Next, the manufacturing method of the high frequency knife 22 of this modification is demonstrated centering on the manufacturing method of a linear part.
FIG. 14 is a process explanatory diagram in plan view for explaining a bonded part arranging process according to a modification of the second embodiment of the present invention. FIGS. 15A and 15B are process explanatory views showing a joining process according to a modification of the second embodiment of the present invention.

First, as shown in FIGS. 13A and 13B, a wire 23A before joining having a wire receiving portion 23b at the tip is formed as a linear component by a linear component forming step.
The wire 23A formed in this step is press-molded in a state where the tip of the blank wire 23d, which is a straight wire of the Zr-based alloy, is heated from the glass transition region to a temperature range of ΔT ₂ , thereby the wire receiving portion 23b. Is formed.
The shape of the wire receiving portion 23b is such that a concave surface 23c made of a cylindrical surface that is dented on one side in the radial direction is formed by pressing the tip of the blank wire 23d from one side in the radial direction with a die (not shown). The back surface side of the concave surface 23c has a substantially semi-cylindrical shape that protrudes radially outward from the outer peripheral surface of the blank wire 23d. For this reason, the wire receiving portion 23b forms a stepped portion protruding to the tip side at a position shifted in the radial direction from the central axis of the blank wire 23d.

Press forming for forming the wire receiving portion 23b is performed in the same manner as the linear part forming step of the second embodiment, using a mold corresponding to the wire receiving portion 23b.
By this step, the wire receiving portion 23b is cooled after being press-molded in a state where the temperature is raised to the temperature range of the glass transition region ΔT ₂ , so that the stepped portion is pressed at a temperature lower than the glass transition temperature. As compared with the case of forming the residual stress, the residual stress is relieved or removed remarkably.

  Next, in the to-be-joined part arrangement | positioning process, as shown in FIG. 14, the front-end | tip of the wire knife part 21 is arrange | positioned adjacent to the concave surface 23c by mounting the front-end | tip of the wire knife part 21 on the concave surface 23c. Since the wire receiving portion 23b that can stably receive the end portion of the wire knife portion 21 is formed at the end portion of the wire 23A, it becomes easy to arrange the wire knife portion 21 and the wire 23A adjacently, It becomes possible to arrange adjacently using a simple holding jig.

  Next, in a joining process, it replaces with metal mold | dies 31A and 31B of the said 2nd Embodiment, and uses metal mold | dies 25A and 25B shown to Fig.15 (a), (b). The molds 25A and 25B each have a mold surface 25c in which a groove part 25a matched to the columnar shape of the joint part 23a is formed on the flat part 25b. A pressure mechanism.

In this step, as shown in FIG. 15A, first, the groove portion 25a is opposed to the wire receiving portion 23b and the end portion of the wire knife portion 21 placed on the concave surface 23c in the adjacent direction. At the same time, the molds 25 </ b> A and 25 </ b> B are disposed at positions where the respective groove portions 25 a are separated from the ends of the wire receiving portion 23 b and the wire knife portion 21. Then, heated die 25A, and 25B to the temperature range of the glass transition region [Delta] T ₂ by the heater unit (not shown). In the present embodiment, the temperature is raised to 450 ° C. as in the linear part forming step.
Next, the molds 25A and 25B are stopped close to each other by the pressurizing mechanism (not shown) until the respective groove portions 25a come into contact with the ends of the wire receiving portion 23b and the wire knife portion 21, and the temperature of the leading wire receiving portion 23b. Until the glass transition temperature _Tg2 is exceeded.
Then, for example, pressing is performed at 20 MPa, the wire receiving portion 23b is deformed, and the shape of each groove portion 25a is transferred.
Thereby, the wire receiving portion 23b follows the shape of the groove portion 25a on the outer peripheral side, and is pressed against the outer peripheral surface of the wire knife portion 21 on the inner peripheral side, and closely adheres to the uneven shape of the wire on the outer periphery of the wire knife portion 21. To do. Since the molds 25A and 25B are pressurized with a pressure of 10 MPa or more, the adhesion between the deformed wire receiving portion 23b and the outer peripheral surface of the wire knife portion 21 is also improved.
In this way, the wire receiving portion 23b is deformed in each groove portion 25a, and the outer periphery of the end portion of the wire knife portion 21 is surrounded in a cylindrical shape or a C shape so that the outer shape is a columnar shape. A shape is formed (see FIG. 15B).

After the elapse of a certain molding time, the heating of the molds 25A and 25B is stopped, and the joint 23a is cooled until the temperature becomes lower than the glass transition temperature _Tg2 .
After this cooling, the molds 25A and 25B are opened to remove the joint 23a.
Thus, the joining process is completed, and the linear portion of the high-frequency knife 22 is formed.

In order to assemble the high-frequency knife 22 using this linear portion, the other end of the joined bonding wire 23 is inserted from the hole 24c of the lumen 24, and the inside of the first tube portion 24a is inserted. Then, with the joint portion 23a inserted through the hole 24c, the other end of the joint wire 23 is further pulled to press-fit the joint portion 23a into the first tube portion 24a. Then, the traction is stopped in a state where the joint 23a has reached a predetermined position. Thereby, the junction part 23a and the 1st pipe part 24a are latched by the frictional force.
Next, the other end side of the wire knife portion 21 is inserted into the first tube portion 24 a from the hole portion 24 d and inserted to the proximal end side of the lumen 24.
Thus, the high frequency knife 22 which is a medical instrument having a linear portion is manufactured.

  In this modification, the wire receiving part 23b for placing the wire knife part 21 is formed at the end of the wire 23A in the linear part forming process. Therefore, the arrangement becomes easier than the arrangement. Further, in the joining step, since the wire receiving portion 23b has already been formed in a semi-cylindrical shape, it is possible to shorten the time for deformation so as to surround the wire knife portion 21, and thus it is possible to perform rapid joining.

  In the above description, the example in which the glass transition temperature of the metal glass is 300 ° C. or higher has been described. However, the glass transition temperature may be higher than the use temperature of the medical instrument, for example, basket forceps Thus, when used at a temperature of about body temperature, a metallic glass having a lower glass transition temperature may be used.

In the above description, an example in which the pressure is 10 MPa or more at the time of press molding in the joining process has been described, but the pressure at the time of press molding in the linear part forming process may be 10 MPa or more. In this case, since the press molding can be performed on the low temperature side of the temperature range of the glass transition region, the molding temperature control becomes easy.
Also, in any of the linear part forming process and the joining process, if there is a margin in the molding temperature control or the molding time, a molding pressure of less than 10 MPa may be adopted as long as the metal glass can be deformed. .

  Further, in the above description, in the bonded component arranging step, the example in which a part of the linear component and the bonded component are arranged in parallel and adjacent to each other in contact with each other is described. If it is, it may be arranged in an intersecting positional relationship.

  Further, in the above description, the example in which the linear joined component is made of a stranded wire has been described, but a single wire may be adopted when a necessary joining strength is obtained.

  Further, in the modification of the second embodiment described above, in order to easily perform the part-to-be-joined placement step and the joining step, the example has been described in which the wire receiving portion 23b is provided at the tip of the wire 23A. In the case where the tip can be easily processed, for example, a process such as reducing the diameter of the tip may be performed on the part to be joined before performing the part placement step.

  In addition, all the constituent elements described in the above embodiments and modifications can be implemented in appropriate combination within the scope of the technical idea of the present invention.

It is typical sectional drawing which shows schematic structure of the medical instrument which concerns on the 1st Embodiment of this invention. It is a perspective view which shows the linear part of the medical device which concerns on the 1st Embodiment of this invention. It is a front view which shows the linear component of the medical instrument which concerns on the 1st Embodiment of this invention. It is a perspective view for demonstrating the linear component formation process of the manufacturing method of the medical device which concerns on the 1st Embodiment of this invention. It is process explanatory drawing of the to-be-joined components arrangement | positioning process of the manufacturing method of the medical device which concerns on the 1st Embodiment of this invention. It is process explanatory drawing which shows an example of the joining process of the manufacturing method of the medical device which concerns on the 1st Embodiment of this invention. It is process explanatory drawing which shows the other example of the joining process of the manufacturing method of the medical device which concerns on the 1st Embodiment of this invention. It is a typical fragmentary sectional view showing a schematic structure of a medical instrument concerning a 2nd embodiment of the present invention. It is a partial front view which shows the linear component of the medical device which concerns on the 2nd Embodiment of this invention. It is process explanatory drawing of the front view of the to-be-joined components arrangement | positioning process of the manufacturing method of the medical device which concerns on the 2nd Embodiment of this invention, and its D view side view. FIG. 9 is a partial enlarged view of a portion C in FIG. It is a typical fragmentary sectional view showing a schematic structure of a medical instrument concerning a modification of a 2nd embodiment of the present invention. It is the top view which shows the linear component of the medical device which concerns on the modification of the 2nd Embodiment of this invention, and its F view. It is process explanatory drawing of the planar view explaining the to-be-joined components arrangement | positioning process which concerns on the modification of the 2nd Embodiment of this invention. It is process explanatory drawing which shows the joining process which concerns on the modification of the 2nd Embodiment of this invention.

Explanation of symbols

1 Basket forceps (medical instruments)
2 Basket portion 2A, 2B, 2C, 2D Basket wire 2a Tip joint portion 2b Base end joint portion 2c Tip portion 2g Base end portions 2h, 2i, 2j, 2k Bending portion 3 Operation wire (linear workpiece to be joined)
10A, 10B, 12A, 12B, 13A, 13B, 25A, 25B, 31A, 31B Mold 11 Blank wire (wire made of amorphous alloy)
16, 22 High-frequency knife (medical device)
17, 24 Lumen 18 Resin cover 19 Bonding wire (Linear part)
20 Bending wire (Linear parts, linear parts to be joined)
21 Wire knife part (Linear parts to be joined)
23 Bonding wire 23A Wire (Linear part)
23d Blank wire 30 Holding jig T _g1 , T _g2 Glass transition temperature T _x1 , T _x2 Crystallizing temperature ΔT ₁ , ΔT ₂ Glass transition region

Claims (4)

A method of manufacturing a medical device having a linear portion,
A wire made of an amorphous alloy having a glass transition region of 20 ° C. or higher is press-molded in a state where the temperature is raised to the temperature range of the glass transition region of the amorphous alloy, and a part of the linear portion is configured. A linear part forming process for forming a linear part to be performed;
A part to be joined arrangement step for arranging a part of the linear part formed by the linear part forming step adjacent to a linear part to be joined constituting the other part of the linear part;
After the parts to be joined are arranged in the joining part arrangement step, the parts to be joined and the wires are heated in a state where a part of the linear parts is heated to the temperature range of the glass transition region of the amorphous alloy. A method for manufacturing a medical device comprising: a step of press-molding a part of the linear part while contacting a part of the linear part and joining the linear part to the part to be joined.   The method for producing a medical device according to claim 1, wherein the amorphous alloy has a glass transition temperature of 300 ° C or higher.   The method for manufacturing a medical device according to claim 1 or 2, wherein in the joining step, press molding is performed at a pressure of 10 MPa or more.   The medical instrument manufactured by the manufacturing method of the medical instrument in any one of Claims 1-3.

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