JP2011177231A - Coiled structure used for medical treatment and method for manufacturing the same; and medical endoscope, medical treatment instrument and ultrasonic or optical interferometry diagnostic and medical treatment catheters using coiled structure for medical treatment - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To disclose a coiled structure for medical treatment, medical treatment instrument, etc. that utilize a coil connection method as the technical task of not deteriorating by thermal effects but improving the mechanical strength properties of metal wires of the coil or coil structure used for medical treatment, when a connection is formed on the coil body in part using a connector attached to the coil body or when a connection by the connector is formed in part between the coiled structure for medical treatment and a connection cap. <P>SOLUTION: The metal wire of coil structure for medical treatment undergoes a strong wire drawing processing of an austenite stainless steel wire and then a winding or twisting processing for the manufacture of a connector material. With attention paid to the temperature and tensile yield strength properties of the high-treated austenite-based stainless steel wire, a connector material is used to form this connector, where its fusion temperature agrees with the temperature to improve its tensile yield strength. Thus the tensile yield strength of metal wire of the coil structure for medical treatment is more improved at the connector. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a medical coil structure having a joint part that is partially joined to a coil body using a joining member, and a joining member at a tip part or a hand part of the coil body or the medical coil structure. The present invention relates to a medical coil structure in which mechanical strength characteristics are improved at a joint part that is partially joined using, and a medical treatment instrument using the medical coil structure.

  For example, a distal end portion of a medical treatment instrument or the like, which is inserted into the body, or a hand operation portion includes a coil body through which an operation rope is inserted, and in order to transmit the hand operation to the tip portion, Considering the mechanical strength characteristics of the joint, it is necessary to satisfy the safety of the human body when treating the lesion, and various proposals have been made for this purpose.

Patent Document 1 describes a medical treatment instrument aimed at obtaining good rotation transmission performance using a contact coil.
However, the strands of the coil body are “welded” and the thin wire melts, and the mechanical strength of the coil body before welding cannot be maintained.

Patent Document 2 describes an endoscope for the purpose of improving the fixing strength by “brazing” the coil body and the connection base.
However, in general, for example, a brazing metal (JIS Z3266) having a melting point of 895 ° C. to 1030 ° C. is used for brazing stainless steel, and in such a case, the metal wire constituting the coil body is melted and welded, or There is no disclosure of brazing material in such patent documents, and there is no disclosure about the correlation between the melting temperature of the brazing material and the mechanical strength characteristics of the coil body. The idea is to use the joining member as a mere fixing means.

  In Patent Document 3, there is a description of the twisting process that improves the rotation transmission performance of the hollow stranded coil body, but in particular, the analysis of the relationship between the rotation load performance of the static load weight and the rotation speed is insufficient, In addition, there is no description of the basic technical idea of the present invention that improves the tensile breaking strength of the metal wire used for the coil body by utilizing the heat of fusion of the joining member.

JP 2010-5430 A JP 2009-153714 A Japanese Patent No. 40986613

Conventionally, an end portion of a coil body formed by winding using a plurality of metal strands is generally welded or the like to prevent a plurality of metal strands from breaking apart. is there. Further, for example, in a medical treatment instrument such as a medical forceps, a coil body inserted with an operation rope is made into a coil body using a stainless steel wire, and a connection base connected to an end of the coil body is joined. At this time, the brazing material, which is a joining member, has only a technical idea as a simple fixing means, and is formed by winding or twisting a metal wire that has been subjected to high-strength drawing with a high degree of processing of stainless steel wire. In connection with joining using eutectic alloy, which is a joining member at the time of brazing and soldering, considering the mechanical strength characteristics due to the thermal effect of the coil body using this strongly processed metal element wire There is no technical idea.
The same applies to a diagnostic medical catheter using a medical coil structure of the present invention described later as a drive shaft.
The object of the present invention is to use austenitic stainless steel wire as a metal wire of the coil body and perform a strong wire drawing process, and use the effect of improving the tensile fracture strength characteristics due to the heat effect on the strongly processed metal wire Thus, by not only using the joining member as a fixing means, but also by disclosing a technical idea related to a new joining that improves the joining strength while improving the tensile breaking strength of the metal wire of the coil body. It is an object of the present invention to provide a medical coil structure that can be safely operated by a person, a medical treatment instrument using the medical coil structure, and a diagnostic medical catheter.

According to the first aspect of the present invention, the medical device is provided with a joint portion that is formed into a coil body using a metal wire having a wire diameter of 0.014 mm to 0.300 mm and then partially joined using a joining member. In the coil structure,
The metal element wire of the coil body is subjected to a solid solution treatment using an austenitic stainless steel wire, followed by wire drawing with a total area reduction of 80% to 99.5%, and a tensile breaking strength of 200 kgf / mm ² or more. 450 kgf / mm ² or less,
The joining member uses a eutectic alloy having a melting temperature of 180 ° C. to 495 ° C., or an eutectic having a melting temperature of 180 ° C. to 525 ° C. when the metal strand is an austenitic stainless steel wire containing Mo. Using alloys,
The medical device characterized in that the partially joined joint joins adjacent lines with a width of 1/20 to 30 times the outer diameter of the coil body in the longitudinal direction of at least one end of the coil body. This is a coil structure for use.
With this configuration, a medical coil structure having high mechanical strength characteristics such as high compression resistance, which improves the tensile breaking strength of the metal wire of the coil body at the joint using the heat of fusion of the joining member Can be obtained.

The invention according to claim 2 is the medical coil body structure according to claim 1,
The metal wire of the coil body is provided with a low temperature heat treatment of 180 ° C. to 495 ° C. after drawing and drawing, or when the metal wire is an austenitic stainless steel wire containing Mo, 180 ° C. to 525 ° C. A low temperature heat treatment is provided, and the wire drawing and the low temperature heat treatment are repeated as at least one set, and then the final wire drawing is provided, and the total area reduction ratio until the final wire drawing is 90% to 99.5. % Is a medical coil structure.
With this configuration, the tensile strength of the metal wire of the coil body at the joint is further improved by utilizing the heat of fusion of the joining member, and the medical device has higher mechanical strength characteristics such as higher compression resistance. A coil structure can be obtained.

According to a third aspect of the present invention, the coil body of the medical coil structure is formed by winding the core bar around the outer periphery of the core bar using 2 to 30 metal strands, and then removing the core bar into a hollow shape. A coil body consisting of a multi-filament, or a coil body consisting of a hollow multi-strand after extracting the core material after twisting the rope around the outer periphery of the core material to form a rope body It is a medical coil structure as described in any one of Claims 1-2 characterized by these.
With this configuration, using a coil body that has improved the tensile breaking strength of the metal strand, the tensile breaking strength of the metal strand of the coil body at the joint using the melting heat of the joining member, and the joining strength of the joint Can be further improved to improve the compression resistance, and in particular, a medical coil structure with improved rotation transmission performance to the distal end side by a rotating operation in a bent state can be obtained.

According to a fourth aspect of the present invention, the coil body of the medical coil structure is provided with an inner layer and an outer layer in close contact with an outer periphery of the inner layer, and the inner layer is different in winding direction or twisting direction. And a coil body comprising a two-layer structure of the outer layer, or an intermediate layer, and an inner layer and an outer layer are provided in close contact with the inner periphery and outer periphery of the intermediate layer, the winding direction of the intermediate layer, or the twisting direction and the inner layer and the 4. The coil body comprising a three-layer structure of the inner layer, the middle layer, and the outer layer, wherein the winding direction or the twisting direction of the outer layer is different. 5. It is a medical coil structure.
With this configuration, a medical coil structure with improved tensile strength of metal strands and improved tensile strength of metal strands at the joint is obtained, particularly compression resistance in a bent state, or It is possible to further improve the transmission of rotation to the tip side by the rotation operation.

The invention according to claim 5 is the coil body according to any one of claims 1 to 4, wherein the coil body of the medical coil structure is a coil body that has been subjected to a low-temperature heat treatment at 180 ° C to 525 ° C. This is a medical coil structure.
With this configuration, the linearity of the medical coil structure can be further improved.

According to a sixth aspect of the present invention, in the coil body of the medical coil structure, the metal element wire is twisted around the outer periphery of the core material to form a rope body, and an electric current is conducted to the rope body to cause electric resistance heating. The other end of the rope body is twisted with the other end of the rope body in a state where 3% to 40% of the tensile breaking force of the rope body is applied to one end of the rope body. After twisting 20 times / m to 200 times / m in the same direction as the direction, reverse twisting is performed in the opposite direction of 10% to 30% of the twisting process, and simultaneously with the twisting process, Alternatively, the coil body is formed of a hollow multi-strand by performing heat treatment by electric resistance heating at 180 ° C. to 525 ° C. during or after the twisting process, and then extracting the core material of the rope body. The medical core according to any one of claims 1 to 4. It is a le structure.
With this configuration, it is possible to obtain a medical coil structure that improves the linearity of the coil body and dramatically improves the rotation transmission property to the distal end side by a rotation operation in a bent state.

The invention according to claim 7 is a wire drawing step of a metal strand of a medical coil structure, a twisting step using a plurality of metal strands as a rope body, a step of setting heat treatment, and a rope A step of applying a tensile force to the body, a twisting process of twisting a predetermined amount in the same direction as the twisting direction of the rope body, and a reverse twisting process of twisting a predetermined amount in the direction opposite to the twisting direction of the rope body And a heat treatment step by electric resistance heating, a cored coil body step, and a joining step of partially joining using a joining member.
With this configuration, it is possible to manufacture a medical coil structure that improves the linearity and dramatically improves the transmission of rotation to the distal end side, particularly by a rotating operation in a bent state.

The invention according to claim 8 is characterized in that, in the cored coil body step, the core material is composed of a core material in which a resin film having a melting temperature of 180 ° C. to 420 ° C. is formed on the outer periphery. In the described invention, after the cored coil body step, a core material in which a resin film having a melting temperature of 180 ° C. to 420 ° C. is formed on the outer peripheral portion is inserted into the hollow coil body, and then the joining member is used. The method for manufacturing a medical coil structure according to claim 7, comprising: a step of partially joining the core material, and a step of extracting the core material on which the resin film is formed.
With this configuration, it is possible to manufacture a medical coil structure having a uniform inner diameter by facilitating the core removal operation and smoothing the inner peripheral surface of the coil body joint portion.

According to a tenth aspect of the present invention, a distal treatment section is provided on the distal end side of the flexible sheath body, and a hand operation section is provided on the hand side, and the distal treatment section and the hand operation section are connected to the flexible sheath body. With a coil body that has been inserted through the rope for operation,
The distal treatment section is composed of a bending section that connects a plurality of bending pieces and connects the distal ends of the bending piece and the operation rope on the distal end side, and operates the hand operation section to control the operation rope. In the medical endoscope in which the bending portion is bent and deformed by the transmission action of the operation force,
The coil body in the flexible sheath body is formed using the medical coil structure according to any one of claims 1 to 6, or is bonded to at least one end of the coil body using the bonding member. A medical endoscope comprising the medical coil structure according to any one of claims 1 to 6, wherein the medical coil structure has a joint part or a joint part partially joined to the bending piece. is there.
With this configuration, the medical coil structure can support the operation reaction force in the structure that transmits the operation force to the tip by supporting the reaction force when operating the operation rope inserted through the medical coil structure. The metal wire used for the coil body, and the surgeon's procedure interruption due to the inability to operate due to a decrease in compression resistance due to insufficient tensile break strength at the joint of the metal wire, the curved portion of the distal treatment section Therefore, it is possible to provide a medical endoscope that can smoothly perform the bending operation and can respond quickly to a procedure.

According to the eleventh aspect of the present invention, a distal treatment section is provided on the distal end side of a flexible tubular body made of a coil body, and a proximal operation section is provided on the proximal side, and an operation rope inserted through the coil body is provided in the distal treatment section. In the medical treatment instrument that is connected to the hand operation unit, and pushes, pulls, or rotates the hand operation unit to transmit the operation force of the operation rope to operate the distal treatment unit,
The coil body of the flexible tubular body is formed using the medical coil structure according to any one of claims 1 to 6, or is joined to at least one end of the coil body using the joining member. A medical treatment instrument comprising the medical coil structure according to any one of claims 1 to 6 having a joint part that is partially joined to a connection base.
With this configuration, the operation force of the operating rope inserted into the medical coil structure cannot be supported, and the operation with reduced compression resistance due to insufficient tensile break strength of the metal wire and the metal wire joint It is possible to prevent the operator's procedure from being interrupted in an inoperable state, to facilitate the smooth operation of the distal treatment section, and to respond quickly to procedures such as excision of the affected area or collection of living tissue and hemostasis while maintaining high operability. Medical treatment tools such as medical forceps and medical clip devices can be provided.

According to a twelfth aspect of the present invention, the proximal side of the flexible tube body includes a connector comprising a drive shaft connector connected to the operation control device of the intravascular ultrasonic diagnostic apparatus by a signal line, and the distal end side is hollow. Consists of a tubular catheter sheath. The catheter sheath has a housing that houses and holds an ultrasonic transducer that functions as a transducer for transmitting and receiving ultrasonic waves. The proximal side extends to the connector and is coiled. In an ultrasonic diagnostic medical catheter that includes a drive shaft formed on the body and renders an intracorporeal tissue image by rotation of the drive shaft.
The said drive shaft is comprised using the medical coil structure as described in any one of Claims 1-6, or the joining partially joined to the said housing or the said drive shaft connector using the said joining member. An ultrasonic diagnostic medical catheter comprising the medical coil structure according to any one of claims 1 to 6 having a portion,
According to a thirteenth aspect of the present invention, the proximal side of the flexible tube body is provided with a connector comprising a drive shaft connector connected to the operation control device of the optical coherence tomography diagnostic apparatus by a signal line, and the distal end side is a hollow tube. A catheter sheath of the body, and a distal end portion of the catheter sheath includes a prism that functions as an optical probe for receiving and receiving low-interference light, or a housing that holds and holds a mirror, and the proximal side extends to the connector. In an optical interference diagnostic medical catheter comprising a drive shaft formed in a coil shape and rendering a tissue image in a body cavity by rotation of the drive shaft,
The said drive shaft is comprised using the medical coil structure as described in any one of Claims 1-6, or the joining partially joined to the said housing or the said drive shaft connector using the said joining member. An optical interference diagnostic medical catheter comprising the medical coil structure according to any one of claims 1 to 6 having a portion.
With this configuration, by using a diagnostic medical catheter having a high strength tensile breaking strength characteristic and a drive shaft made of a medical coil structure with high rotational transmission to the tip, a housing or the like using a joining member Vascular tomographic image unevenness due to rotational fluctuations according to the degree of bending is eliminated by using a diagnostic medical catheter equipped with a drive shaft of a medical coil structure having a joint portion and a good blood vessel. By obtaining a tomographic image, the operator can accurately determine the diagnosis of arteriosclerosis, the preoperative diagnosis at the time of blood vessel treatment such as a balloon catheter, or the confirmation of treatment after the operation. An ultrasonic diagnostic medical catheter and an optical interference diagnostic medical catheter used in such a case can be provided.

The block diagram of the medical coil structure of this invention. Total area reduction ratio and tensile breaking strength characteristic diagram. The temperature and tensile breaking strength characteristic figure of the metal strand of the medical coil structure of this invention. The block diagram of the medical guide wire which uses the medical coil structure of this invention. The block diagram of the medical endoscope which uses the medical coil structure of this invention. The block diagram of the medical treatment tool which is a medical forceps which uses the medical coil structure of this invention. The block diagram of the medical treatment tool which is a medical clip apparatus which uses the medical coil structure of this invention. FIG. The block diagram of the diagnostic medical catheter which uses the medical coil structure of this invention as a drive shaft. The coil body twisting device of the medical coil structure of the present invention. Process drawing of the primary to tertiary molded body of the coil body of the medical coil structure of the present invention. Explanatory drawing of the rotational performance test of the medical coil structure of this invention, and its handling state.

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

FIG. 1 shows an embodiment of a medical coil structure according to the present invention, and FIG. 1 (a) shows a joint portion 6 partially formed by using a joining member 7 on a coil body 5 formed by winding using one metal wire. It is the medical coil structure 1 of Example 1A-1E which has.
The coil average diameter (D0) is 0.194 mm to 0.377 mm (0.275 mm in Example 1A), and the wire diameter of the metal strand is 0.050 mm to 0.090 mm (0.065 mm in Example 1A). ) And a joining portion 6 of reference numerals 61 and 62 that are partially joined using a joining member 7 described later is provided, and the outer diameter D01 of the joining portion 6 is approximately the outer diameter of the coil body 5. The length in the longitudinal direction (L1, L2) of the joint 6 is approximately 1/20 to 30 times the outer diameter of the coil body (0.2 mm to 5 mm in this embodiment). A preferred embodiment is a medical guide wire 100 described later.
In the coil structure 1 for medical use, the coil average outer diameter (D0) is 0.124 mm to 0.292 mm (0. Austenitic stainless steel having a wire diameter of 0.014 mm to 0.040 mm (0.030 mm in this Example 1B and 0.040 mm in Example 1C) at 160 mm, 0.220 mm in Example 1C) The line is used.
As a preferable application example, a medical treatment in the form of a double coil in which a small-diameter medical guide wire 100 described later or an inner coil body 56 having a small outer diameter is provided concentrically in the outer coil spring body 3a. Guide wire. (Fig. 4)
And as the medical coil structure 1 of Example 1D whose wire diameter of the metal strand of a coil wire is thicker than the said Examples 1A-1C, a coil average diameter (D0) is 0.40 mm to 1.75 mm ( Austenitic stainless steel of 0.74 mm in Example 1D and 1.72 mm in Example 1E), and the strand diameter of the metal strand is 0.15 mm to 0.30 mm (0.26 mm in Examples 1D and 1E). The outer diameter (D01) and the lengths in the longitudinal direction (L1, L2) of the bonding member 7 and the bonding portion 6 are substantially the same as those of the above-described Examples 1A to 1C. As a suitable application example, an operation rope is inserted into a coil body, and a medical endoscope 101 and a medical forceps described later having a medical coil structure 1 that requires high compression resistance are used. This is a medical treatment instrument (102A, 102B).

Next, FIG. 1 (b) is a medical coil structure 2 of Examples 2A to 2C, which is composed of multiple strands that are formed by winding or twisting into a coil shape using 2 to 30 metal strands. is there. The coil average diameter, the strand diameter of the metal strand, the shape of the joining portion 6 (reference numeral 61), and the joining member 7 are substantially the same as those of Examples 1A to 1E.
Example 2A is a medical coil structure 2 having a coil average diameter of 0.160 mm, which is formed by winding or twisting using six metal strands having a strand diameter of 0.030 mm, and is suitable for use. An example is a medical guide wire in the form of a double coil in which an inner coil body 5b having a small outer diameter is provided concentrically in the outer coil spring body 3a, as in Examples 1A to 1C.
In addition, as Example 2B, the medical coil structure 2 having an average coil diameter of 0.74 mm by forming or twisting 26 metal strands having a strand diameter of 0.26 mm as a suitable application example The medical treatment instrument 102A such as a medical forceps, a medical clip device, a medical high-frequency knife or the like that is required to have compression resistance, which will be described later, and also has a rotation transmission performance that transmits rotation on the proximal side to the distal end side. , 102B.

Further, as Example 2C, a coil body 5 having an average coil diameter of 1.72 mm formed by winding or twisting 18 metal strands having a strand diameter of 0.26 mm, and having the same resistance as Example 2B. In addition to the medical treatment instrument that requires compressibility and rotational transmission, this is a drive shaft for a diagnostic medical catheter used in an intravascular ultrasound diagnostic apparatus, an optical coherence tomography diagnostic apparatus, or the like described later.
Here, the “coiled body of winding” means that a plurality of metal wires are wound around a cored bar (mandrel) to form a coil, and then the cored bar is extracted to form a coiled body. In addition, “coiled body of twisted configuration” means that a plurality of metal strands are used to twist a side material around the core material and twisted into a rope shape, and then the core material is extracted to form a coil body. Say.
In the case of this winding forming, a gap is easily opened between adjacent wires for every total number of metal strands to be wound (for example, every 4 if the number of metal strands is 4). On the other hand, in the case of the twisted configuration, since the ropes are twisted so as to be twisted, there is a difference that no gap is generated between the adjacent wires for each total number of metal strands. The difference in the presence or absence of this gap affects the rotation transmission.

Next, FIG. 1 (c) shows a medical coil structure 3 having a two-layer structure in which an inner layer coil body 52 is provided in close contact with an inner side of an outer layer coil body 51 using the medical coil structure 2. The illustrated (2) is a medical coil structure 4 having a three-layer structure in which an intermediate layer coil body 53 is provided in close contact with the medical coil structure 3 between an outer layer coil body 51 and an inner layer coil body 52. Indicates.
In each of the medical coil structures 3 and 4, the coil average diameter (D1) of the outer layer coil body 51 is 0.901 mm to 1.28 mm, and the strand diameter of the metal strand is 0.10 mm to 0. Coil averages corresponding to the wire diameters of the metal wires to be used, provided with an outer layer coil body 51 that is formed by winding or twisting into a coil shape using 2 to 30 austenitic stainless steel wires of 30 mm A two-layered medical coil structure 3 having a diameter inner-layer coil body 52 and a three-layered medical coil structure 4 having an intermediate-layer coil body 53 between the outer-layer coil body 51 and the inner-layer coil body 52; The shape of the joint 61 and the joint member 7 are substantially the same as those of the medical coil structures 1 and 2.
And, the winding direction of the coil body of each layer, or the twisting direction may all be the same direction, but in order to obtain uniform flexibility and high rotational transmission to the tip side, each layer is preferably reverse direction, For example, if the winding direction or the twisting direction of the outer layer coil body 51 is the Z winding direction (right thread), the middle layer coil body 53 is the reverse S winding direction (left thread), and the inner layer coil body 53 is the outer layer coil. For example, a combination of the Z-winding direction (right-hand thread) in the same direction as the body 51 is used.

  As Example 3A of the medical coil structure 3 having this two-layer structure, a coil average diameter (D1) is formed by winding or twisting 16 metal strands having a strand diameter (d1) of 0.16 mm. ) Is 0.96 mm and the inner layer coil having an average coil diameter (D2) of 0.64 mm is formed by winding or twisting 11 wire elements having the same wire diameter (d2). As Example 4A of the medical coil structure 3 composed of the body 52 and the medical coil structure 4 composed of the three-layer structure, 22 metal strands having a strand diameter (d1) of 0.14 mm are wound or formed, or An outer coil body 51 having a coil average diameter (D1) of 1.18 mm and 17 metal strands having the same wire diameter (d3) are formed by winding or twisted to form a coil average diameter. (D3) is 0.90 mm middle layer coil body 53 and the same wire diameter (d2 Forming the metal filaments 12 wound, or twisted configuration to coil mean diameter (D2) is a medical coil structure 4 composed of inner coil 52 of 0.62 mm.

  Examples of these preferred applications include a medical clip device that places importance on the ability to transmit rotation to the distal end, and a coil body used for the sheath of the medical treatment instrument 102A, 102B such as a medical high-frequency knife. An application example is a drive shaft 5e of diagnostic medical catheters 103 and 104 used in an intravascular ultrasonic diagnostic apparatus or an optical coherence tomographic diagnostic apparatus described later.

Tables 1 and 2 show the manufacturing process of the wire diameter 0.26 mm of the metal wire used in Examples 1D, 1E, 2B, and 2C and the wire diameter 0.065 mm of the metal wire used in Example 1A, respectively. Show. In addition, the material of the metal wire used in Examples 1D, 1E, 2B, and 2C was an austenitic stainless steel wire SUS304 material, and the metal wire used in Example 1A was an SUS316 material containing Mo. In addition, since the code | symbol of the metal strand in a table | surface has the difference in the area reduction rate of a wire drawing process, or the difference in the presence or absence of a low-temperature heat processing process, it shows each division | segmentation description.
Here, the term total reduction rate and the drawing of the wire by using a solid solution treated wire (e.g. wire tensile strength by heat treatment at 1050 ° C. has a property of 80 kgf / mm ² from 60 kgf / mm ²⁾ This refers to the difference in cross-sectional area between the previous wire diameter and the final wire diameter after the wire drawing process using multiple dies. Is the area reduction rate, and the area reduction rate after the complete wire drawing process is classified as the total area reduction rate. In addition, the tensile breaking strength is a value obtained by dividing the value obtained when a tensile force is applied to a wire by the sectional area of the wire, and the tensile breaking force is a value obtained when a tensile force is applied to the wire. Means the value of
In addition, the “low temperature heat treatment” referred to here is annealing that lowers the tensile strength at break and softens the steel wire by reducing the hardness, or low temperature annealing, and heats above the transformation point (Example Ac ₃ about 730 ° C. or higher). Unlike normalizing, it is called “low-temperature heat treatment” and is distinguished from heat treatment in which the tensile strength at break increases and mechanical properties are improved.

According to Table 1, the metal wire a, by reduction of area of the wire drawing step is 79.9% tensile strength increased from 70 kgf / mm ² to 206kgf / mm ^2, and a metal wire The tensile strength at break of the metal wire b in which the surface area reduction rate of the wire drawing process is improved by 89.9% from that of a is increased from 70 kgf / mm ² to 224 kgf / mm ² and increased from that of the metal wire a.
The metal wire c is subjected to primary low-temperature heat treatment (at 450 ° C., 30 ° C. in this embodiment) by atmospheric heating in a furnace using a heat treatment furnace at a temperature range of 180 ° C. to 495 ° C. for 10 minutes to 180 minutes after the primary wire drawing. After that, the secondary wire drawing (final wire drawing in the present example) is performed and the total area reduction rate is 89.9%. tensile strength at break a total reduction of area of the same line b can be increased further 14 kgf / mm ² tensile strength than the metal wire b becomes 238kgf / mm ^2.
Also, according to Table 2, the same tendency as described above is shown for the metal wires d and e, and the same low temperature after the primary drawing with respect to the metal wire d having the same total area reduction rate. By applying heat treatment (450 ° C., 30 minutes in the present embodiment), the tensile strength of the metal wire e is 264 kgf / mm ² and is increased by 38 kgf / mm ² than the metal wire d. Can do.

From Tables 1 and 2, it is possible to secure a tensile breaking strength of 200 kgf / mm ² or more when the total area reduction is 80% or more, and a tensile breaking strength of at least 210 kgf / mm ^{2 when the} total area reduction is 90% or more. The above can be ensured. Further, according to Tables 1 and 2, the tensile strength of the metal wire increases with an increase in the area reduction ratio in the wire drawing process, and the tensile strength of the metal wire is increased by applying a low temperature heat treatment within a certain temperature range. Strength increases.
The metal wire c has a metal rupture strength increase rate of 5.8% when a low-temperature heat treatment is applied after wire drawing with a surface reduction rate of 80.7%. For the wire e, when the low-temperature heat treatment is applied after the wire drawing process with a surface reduction rate of 91%, the increase rate of the tensile breaking strength is 16%, which is increased by about 2.7 times or more. As the low-temperature heat treatment is applied after the wire process, the tensile strength at break tends to increase steeply. This tendency is prominent when the total area reduction rate is 80% and the total area reduction rate is 90%, and the total area reduction rate is 95%, which will be described later with reference to FIG.

  Next, Table 3 shows manufacturing steps in which the strand diameters of the metal strands used in Examples 3A and 4A are 0.16 mm (metal strand f) and 0.14 mm (metal strand g).

According to Table 3, the metal strand f having a strand diameter of 0.14 mm has a tensile breaking strength of a solid solution treated austenitic stainless steel wire (SUS316 containing 2 to 3 wt% Mo) of 79 kgf / mm. Primary low-temperature heat treatment by atmospheric heating in a furnace using a heat treatment furnace at 180 ° C. to 525 ° C. for 10 minutes to 180 minutes after primary wire drawing using a wire diameter of 1.10 mm of the wire (bus wire) ² (this implementation) In the example, it is performed at 450 ° C. for 30 minutes), after which secondary wire drawing is performed, followed by secondary low-temperature heat treatment under the same conditions as the primary low-temperature heat treatment, followed by tertiary wire drawing (final wire drawing in this example). The total area reduction rate was 98.4%, and the tensile strength at break was 400 kgf / mm ² . The same process was performed for the metal wire g having a strand diameter of 0.16 mm, and the total area reduction rate was 99.5% and the tensile breaking strength was 402 kgf / mm ^2. Shows the highest value. Accordingly, the total area reduction rate is 99.5% and the tensile strength at break can be ensured to be 400 kgf / mm ² .
Moreover, in order to further improve the tensile breaking strength of the metal wire used in each example, it is desirable to repeat the wire drawing step and the low-temperature heat treatment step as one set, and at least one set is repeated, and five sets or more are repeated. However, 3 sets or less are desirable from the viewpoint of productivity and the like.

  And next, what performed the low-temperature heat processing for a short time using the said metal strands f and g is set as the metal strand h and i, respectively, and Table 4 shows the relationship between short-time low-temperature heat processing and tensile fracture strength. . Note that the temperature and time take into account the melting and heating time when assembling using the joining member 7 to be described later, the assembly time, etc., and the time of 2 seconds is when joining and fixing using the joining member 7 The average time during which the bonding member 7 is melted and the coil body 5 is heated at 180 ° C. or higher is shown, and the coil body 5 is reheated at 180 ° C. or higher by the bonding and fixing operation (redoing operation) for 60 seconds. The time including is shown.

According to Table 4, a metal strand h having a total area reduction ratio of 98.4% and a strand diameter of 0.14 mm has a tensile breaking strength of 6.7% even when subjected to a low-temperature heat treatment at 450 ° C. for 60 seconds. Also, the tensile strength at break increases by 3.5% even after a short low-temperature heat treatment for 2 seconds. Further, the metal wire i having a total area reduction of 99.5% and a wire diameter of 0.16 mm exhibits a higher tensile rupture strength at a higher rate than in Example h.
The reason why the tensile fracture strength is improved even in such a low temperature heat treatment for a short time is that the concentrated stress generated locally at the time of wire drawing with a high total area reduction is reduced to a low temperature heat treatment in a certain temperature range. Therefore, it can be considered that the concentrated stress is averaged, and this tendency is more remarkable as the total area reduction is higher.

In order to further improve the tensile breaking strength of the metal wire used in each of the above examples, the temperature range of the low-temperature heat treatment is the tensile breaking strength in the temperature and tensile breaking strength characteristics (FIG. 3) of the metal strand to be described later. A temperature range in which the strength is increased is preferably 180 ° C. to 525 ° C., more preferably 300 ° C. to 495 ° C.
In addition, the tensile breaking force can be improved even by short-time low-temperature heat treatment of 2 seconds to 180 seconds (2 seconds and 60 seconds in this embodiment). Even if it is a short time to join, it is thought that the effect similar to the said short time low-temperature heat processing is shown.
The reason for this is considered to be that the metal element wire is a strong wire drawing process, and at the same time, the wire diameter is 0.300 mm or less, and the heat capacity is extremely small.
As a result, it is possible to obtain a medical coil structure with improved bending fatigue resistance accompanying the effect of improving the tensile fracture strength at the joint using the joining member 7.

  Further, according to Tables 3 and 4, even after heating for a short time after the final drawing of the metal wires f and g (after the third wire drawing in Examples f and g), the tensile break of the metal wires is performed. Strength is improved, as shown in each of the above examples, “low temperature heat treatment” after drawing before final drawing and “short time (2 seconds to 180 seconds) low temperature heat treatment” after final drawing. By using together, the tensile breaking strength of a metal strand can be improved more.

Next, the relationship between the total area reduction of the metal wires used for the medical coil structures 1 to 4 and the tensile breaking strength, and the relationship between the temperature and the tensile breaking strength will be described.
FIG. 2 shows the relationship between the total surface area reduction ratio and the tensile strength at break of the metal strand. According to FIG. 2, the tensile strength at break shows a tendency that the total area reduction rate increases steeply after 80%.
The reason why the total surface area reduction ratio of the metal wires in each of the above examples is 80% or more is that it becomes an inflection point at which the tensile breaking stress increases at 80% as a boundary. (See Fig. 6 and Spring 3rd edition Maruzen Co., Ltd., p. 63, Fig. 2.82) And, with the total area reduction rate of 90% as a boundary, the tensile rupture strength suddenly increases sharply and the total area reduction It has been found that when the rate reaches 95%, the inflection point increases dramatically.
This is because a fibrous structure appeared as the degree of processing increased due to wire drawing by strong processing with a total area reduction of 80% or more, and this fibrous structure developed significantly at a total area reduction of 90% or more. It is thought that.
The total area reduction ratio is 99.5% or less because, when the degree of wire drawing is higher than this, voids begin to appear in the metal structure and the embrittlement is remarkable, and this is particularly fine as 0.06 mm or less. This is because it is considered the limit of wire drawing.
Therefore, the total area reduction is preferably 80% to 99.5%, more preferably 90% to 99.5%, and most preferably 90% to 99%. And the reason why it is 99% or less is that, for example, when the metal strands are twisted and configured like the medical coil structures 1 to 4, the metal strands are not sufficiently stretched, and particularly when the twisted configuration, This is because breakage of the strands is likely to occur.

  And, the above-mentioned metal element wire was made into “solution-drawn austenitic stainless steel wire drawing” in order to obtain an austenitic structure with good workability, and the austenitic stainless steel wire was heat-treated using a transformation point. This is because the crystal grains cannot be refined by the above-described method, the crystal grains can be refined only by cold working, and the tensile strength can be improved by exhibiting remarkable work-hardness by the wire drawing. The reason for using austenitic stainless steel wire is that martensitic stainless steel wire exhibits quench hardenability by heat treatment and is easily affected by heat, and precipitation hardened stainless steel wire (SUS630, etc.) has insufficient toughness and is twisted. This is because wire breakage occurs at the time of the composition, and the twisted composition of the fine wire and the ultrathin wire cannot be made as in the above-described embodiment, and the ferritic stainless steel wire has a problem of temperature brittleness (sigma brittleness).

Next, FIG. 3 shows that the austenitic stainless steel wire is generally used as the metal wire, and the metal wire after the final wire drawing with a total area reduction of 90% or more is under the influence of heat (each temperature is 30 minutes). FIG. 5 is a diagram showing the tensile breaking strength characteristics of FIG. 5 and is shown in the figure for SUS304 material and shown in the figure for SUS316 material.
According to this, SUS304 material begins to increase in tensile rupture strength due to the heat effect at 180 ° C and steeply slopes, and shows the highest tensile rupture strength property in the vicinity of 450 ° C. When the temperature exceeds 520 ° C., the tensile strength at break is lowered more rapidly than normal temperature (20 ° C.). The SUS316 material containing Mo shows the same tendency as the SUS304 material on the low temperature side, but shows the highest tensile rupture strength characteristics at about 480 ° C. on the high temperature side, and the effect of improving the tensile rupture strength properties to 525 ° C. is remarkable. In addition, when the temperature exceeds 540 ° C., the tensile strength at break decreases more rapidly than normal temperature (20 ° C.).
The reason why the tensile strength at break is abruptly decreased is that when the austenitic stainless steel wire subjected to solution treatment is heated from 520 ° C. and 540 ° C. to 800 ° C., carbon precipitation and chromium migration occur. Energy is required, and a sensitization phenomenon occurs, and this sensitization phenomenon appears at 700 ° C. for about 4 to 5 minutes, particularly in a normal SUS304 austenitic stainless steel wire having a carbon content of 0.08% or less. This is because the tensile strength at break is extremely reduced.

  In order to improve the tensile breaking strength because of having such tensile breaking strength characteristics, for example, the temperature range of the low temperature heat treatment for SUS304 material is from 180 ° C., which is a temperature range where the tensile breaking strength increases steeply. 495 ° C. is desirable, and the temperature range of low-temperature heat treatment of, for example, SUS316 material (Mo is 2 wt% to 3 wt%) containing Mo is desirably 180 ° C. to 525 ° C.

Further, the joining member 7 for joining the metal strands preferably has a melting temperature in a temperature range (180 ° C. to 525 ° C.) that matches the temperature range in which the tensile breaking strength of the metal strands increases steeply. By using a eutectic alloy that melts in step (b), a new technical idea is provided that allows strong bonding while improving the tensile breaking strength of the metal strand of the joint.
Thus, according to the present invention, the tensile breaking strength characteristics depending on the temperature of an austenitic stainless steel wire having a high total area reduction ratio after being subjected to strong wire drawing, and the metal element wire are easily affected by heat due to the fine wire and the fine wire. Paying attention to this, it is a new idea that a joining member such as a solder material or a brazing material is not used as a mere fixing means, but is firmly joined while improving the tensile breaking strength of the metal wire.

  The joining member 7 uses a eutectic alloy having a melting temperature of 180 ° C. to 495 ° C., or an eutectic alloy having a melting point of 180 ° C. to 525 ° C. when the metal strand is an austenitic stainless steel wire containing Mo. The eutectic alloy here refers to a special alloy having the lowest melting point (melting temperature) obtained by changing the component ratio of the alloy, and specifically, an alloy material containing gold or silver. 80% by weight of gold as a tin-based alloy material, the balance being tin and a melting temperature of 280 ° C., and 3.5% by weight of silver as a tin-based alloy, the balance being tin and a melting temperature of 221 ° C., and 88% by weight of gold, The balance is germanium, which is a eutectic alloy having a melting temperature of 356 ° C., silver, tin, and indium, and having a melting temperature of 450 ° C. to 472 ° C. Typical examples are shown in Table 5.

  Here, the reason for using gold as the bonding member 7 is to improve visibility under radioscopy, and to improve corrosion resistance and spreadability. The reason to use silver is to adjust the melting point and the reason to use tin. In order to improve the wettability with the core wire 2 or the coil body 5 by lowering the melting point, the reason for using indium and copper is to improve the wettability, and the reason for using germanium is an intermetallic compound This is to suppress the coarsening of the crystal grains and prevent a decrease in the bonding strength.

And the melting temperature of the joining member 7 was set to 180 ° C. to 495 ° C., or 180 ° C. to 525 ° C. The tensile breaking strength of each metal wire that was work-hardened below 180 ° C. was set to the melting temperature of the joining member 7. When the temperature exceeds 495 ° C., the austenitic stainless steel wire has characteristics that are higher than 495 ° C., and when the temperature exceeds 525 ° C. When a stainless steel wire is heated to 520 ° C. or 800 ° C. exceeding 540 ° C., a sensitization phenomenon occurs, and as described above, the tensile strength at break is extremely reduced. This is to maximize the mechanical strength characteristics of the coil body 5 formed by winding or twisting the wire and the metal element wire.
And the tensile breaking strength of the metal strand of each joining part increases with the fusion heat of the joining member 7, The tensile stress increases with this tensile breaking strength increase, As a result, the metallic strand in a joining part, and medical use The bending fatigue resistance of the coil structures 1 to 4 is improved.

In addition, if a silver solder having a melting temperature of 605 ° C. to 800 ° C. or a gold solder having a melting temperature of 895 ° C. to 1030 ° C. is used, as described above, embrittlement due to the sensitization phenomenon of the metal wire, Alternatively, the tensile rupture strength is greatly reduced due to the annealing state, and the coil body 5 is likely to be buckled as the tensile rupture strength and bending stress are reduced.
Then, a gold solder having a melting temperature of about 880 ° C. and having a gold content of 74.5% to 75.5% by weight, silver of 12% to 13% by weight, and other zinc, iron, lead, etc. of 0.15% by weight or less was used. In this case, the same problem as described above also occurs when a silver solder having a melting temperature of 780 ° C. of 72 wt% silver and 28 wt% copper is used.

As examples of applications using the medical coil structure, medical guidewires, medical endoscopes, medical treatment tools, etc., which will be described later, are immersed in physiological saline before the procedure, or physiological saline after the procedure is used. For cleaning, for example, when the joining member 7 uses a silver-based eutectic alloy, blackening starts due to the formation of silver sulfide or the like within about one hour of immersion, and the blackening further progresses over time, causing corrosion. Increases and decreases the bonding strength. For this reason, it is desirable to use a bonding member 7 made of a gold eutectic alloy in order to prevent a decrease in bonding strength due to the progress of corrosion and to prevent blackening.
If the mating member to be joined to the coil body 5 is a connection base, which will be described later, or the housing is gold, a material containing a gold component, and a gold-plated material, the wettability with the joining member 7 is improved, which is more desirable. It is a joining form.

  And the chemical composition of the austenitic stainless steel wire of the metal strand used for each Example of this invention is C: 0.15% or less, Si: 1% or less, Mn: 2% or less, Ni: 6 by weight%. %: 16%, Cr: 16% -20%, P: 0.045% or less, S: 0.030% or less, Mo: 3% or less, the balance being iron and inevitable impurities. Thus, high strength austenitic stainless steel can be obtained by using the above method without using high silicon stainless steel (Si: 3.0% to 5.0%) or precipitation hardening stainless steel wire (SUS630 or the like). A metal wire of a steel wire can be obtained. C is preferably 0.005% or more for improving the tensile strength at break, and is preferably 0.15% or less from the viewpoint of suppressing intergranular corrosion.

The metal wire used in each embodiment of the present invention is an austenitic stainless steel wire having a wire diameter of 0.014 mm to 0.300 mm, and in particular, a fine wire / extra fine wire having a wire diameter of 0.100 mm or less. Therefore, in order to enable wire drawing with a total area reduction of 94% or more while further improving high productivity, SUS304 material or SUS316 material using a remelting material is desirable.
The reason for this is that the cause of disconnection when drawing a stainless steel wire is most often oxide inclusions as well as surface flaws, and this tendency becomes more prominent as the wire becomes finer and finer.
And the chemical component is low in the components of Al, Ti, Ca, O, which are inclusion generation elements, and also suppresses S that causes a reduction in wire drawing due to the action of sulfide. The specific chemical components of the austenitic stainless steel wire are, by weight, C: 0.08% or less, Si: 0.10% or less, Mn: 2% or less, P: 0.045% or less, S: 0 0.010% or less, Ni: 8% to 12%, Cr: 16% to 20%, Mo: 3% or less, Al: 0.0020% or less, Ti: 0.10% or less, Ca: 0.005% or less , O: 0.0020% or less, with the balance being Fe and inevitable impurities. And as a manufacturing method of a remelting material, it is the manufacturing method etc. of the electroslag remelting which used the flux for the ingot after melting of stainless steel. Even when a triple melting material is used, the same effect as described above can be obtained.

  Next, a medical treatment instrument such as a medical guide wire, a medical endoscope, a medical forceps, and a diagnosis for an application example using the medical coil structure including the metal wires a to i and the joining member 7 and diagnosis The medical catheter will be described in the following order.

  FIG. 4 shows a medical guide wire 100 of the application example provided with the medical coil structure 1, and the core wire tip 11 a of the core wire 1 a has a gradually changing diameter shape from the proximal side to the tip side, and is coaxially arranged outside. The fitted coil spring body 3a is formed, the front end side is composed of a radiopaque material coil 4a such as gold, platinum, tungsten, and the like, and the rear end side is composed of a radiolucent material coil body 5a, and the front end of the radiopaque material coil 4a A leading plug 63 having a rounded tip is formed at the portion, which is partially bonded using the bonding member 7, and the outer peripheral portion of the coil spring body 3a and the outer peripheral portion of the core wire proximal portion 12a include fluorine resin, Alternatively, a resin film 8a such as a polyurethane resin is formed, and a hydrophilic film 9a exhibiting lubricating characteristics when wet is formed on the outer periphery thereof.

The coil body 5a has a coil average diameter (D0) of 0.275 mm and a wire diameter (diameter) of 0.065 mm. From the proximal side of the core wire tip 11a to the tip side, the rear end joint 65 and two intermediate joints Each of the portions 64 partially joins the core wire tip portion 11a and the coil body 5a using the joining member 7.
The rear end joint portion 65 has a width (L6) of 1/20 to 30 times the outer diameter of the coil body in the longitudinal direction (in this embodiment, 2 mm) and has a substantially conical shape tapered toward the hand side. Reference numeral 64 denotes the medical device of Example 1A, which includes an annular joint 6 having a width (L5) of 1/20 to 30 times the outer diameter of the coil body (0.5 mm to 1.5 mm in this embodiment) in the longitudinal direction. 1 is a medical guide wire 100 including a coil structure 1 for medical use.
By this structure, by using the metal strand of the coil body 5a having a high strength tensile break strength, by utilizing the heat of fusion of the joining member 7, further improving the tensile break strength of the metal strand at the joint, It is possible to improve the torsional resistance characteristics of the coil body 5a due to the rotation operation of the medical guide wire 100 and the repeated bending fatigue resistance characteristics of the coil body 5a due to the pushing operation.
This is because the resistance to repeated bending fatigue is improved as the combined stress of bending stress and tensile stress increases, and the metal wire used for the coil body has high tensile breaking strength and improved tensile stress. is there.

Further, by providing the intermediate joint portion 64 of the coil body 5a using the joining member 7, in addition to improving the tensile breaking strength, the rotation transmission performance to the distal end side by the hand side rotation operation is dramatically improved. Can be improved.
The reason for this is that when the coil body 5 is considered as a torsion spring, the torsional force (torsion moment M) is inversely proportional to the average coil diameter (D0) and the number of turns of the coil (N) (M１ ／ 1 / D0 × 1 / N). Therefore, for example, if there is one intermediate joint 64 at the central position with respect to the longitudinal direction of the coil body 5, the number N of turns of the coil body 5 is halved and the torsional moment M is doubled. As the number of turns decreases, the corresponding torsional moment increases.
As the intermediate joint 64 increases, the number of metal strands that utilize the heat of fusion of the joining member 7 increases, resulting in a coil body 5 with improved tensile breaking strength. This is because the transmission performance can be dramatically improved.

  In addition, since the medical guide wire 100 is immersed in a container filled with physiological saline before use, for example, when a silver-based eutectic alloy is used for the joining member 7, as described above, the sulfide is used. Due to the formation of silver or the like, blackening proceeds and corrosion increases, and the bonding strength decreases with time. In order to prevent this, it is desirable to use a bonding member 7 made of a gold eutectic alloy.

Further, in addition, the medical guide wire includes a core wire made of a flexible elongated body, a coil body made of a radiopaque material on the front end side and a radiation body on the rear end side. In a medical guide wire in which a coil body of a permeable material is mounted, and the core wire and the coil body on the rear end side are partially bonded using a bonding member,
The metal element wire of the coil member of the radiation transmitting material on the rear end side is subjected to wire drawing with a total area reduction of 80% to 99.5% after being subjected to a solution treatment using an austenitic stainless steel wire. the breaking strength and 200 kgf / mm ² or more 450 kgf / mm ² or less,
The joining member uses a eutectic alloy having a melting temperature of 180 ° C. to 495 ° C., or an eutectic having a melting temperature of 180 ° C. to 525 ° C. when the metal strand is an austenitic stainless steel wire containing Mo. Using the alloy, the partially joined joint joins adjacent wires with a width of 1/20 to 30 times the outer diameter of the coil body on the rear end side in the longitudinal direction, or between adjacent wires and the core wire. It is a medical guide wire characterized by bonding.

FIG. 5 shows a medical endoscope 101 of an application example including the medical coil structure 1 or 2. The illustration (a) shows an overall view of the medical endoscope 101, which is composed of a bending portion 1b, a flexible sheath body 2b, and a hand operation portion 3b from the distal end side. Also, (b) shows the internal structure of the bending portion 1b, and the first coil body 5 into which the first operation rope 9b is inserted has the connection base 8 on the hand side or the bending piece 11b and the joining member 7 as shown. The first operation rope 9b is joined to the bending piece 11b at the distal end.
And the 2nd coil body 51 in which the rope 10b for 2nd operation was penetrated uses the connecting piece 8, the bending piece 11b of the intermediate position of the bending part 1b, and the joining member 7 using the joining member 7 similarly to the above. Partially joined to form the joined portion 6, the tip of the second operation rope 10b is joined to the bending piece 11b at the tip, and the first or second operation rope 9b, 10b is pulled by the hand portion. By operating, the first or second coil body 5, 51 receives an operation reaction force and supports this force, whereby the bending portion 1b is bent and deformed to a desired position.

  The first coil body 5 and the second coil body 51 are each formed by winding one wire having an average coil diameter of 0.74 mm, an average coil diameter (D0) of 0.74 mm, and a wire diameter (diameter) of 0.26 mm. The width of the joint 6 in the longitudinal direction is 1/20 to 30 times the coil body outer diameter (5 mm in this embodiment), or the coil average diameter (D0) is 0.74 mm. In the medical coil, the wire diameter (diameter) is 0.26 mm and 26 wire rods are formed by winding or twisting, and the width of the joint portion 6 in the longitudinal direction is the same as described above, and has the configuration of Example 2B. This is a medical endoscope 101 formed by using the structure 1 or 2 or forming the medical coil structure 1 or 2 to be joined using the joining member 7.

With this configuration, the metal strands of the coil members 5 and 51 made of a metal strand having a high strength tensile breaking strength are used to utilize the heat of fusion of the joining member 7, and further the metal strands at the joint 6. By improving the tensile breaking strength, the amount of contraction due to the compression of the first and second coil bodies 5 and 51 receiving the compressive force by receiving the operating force of the operating rope is reduced, and the loss of the operating amount is reduced. As a result, the bending deformation of the bending portion 1b can be facilitated with a small amount of operation, and the responsiveness of the hand operating portion to the bending portion can be improved.
This is because the compression load resistance is improved because the tensile breaking strength of the metal wires constituting the first and second coil bodies 5 and 51 is improved.
Furthermore, by using the medical coil structure 2 composed of the multi-strands of Example 2B, it is possible to further improve the responsiveness to the bending portion by the hand operation.
The reason for this is that when the coil body made of a single wire as in Example 1D is inserted into the body and bent and deformed, the coil body on the side where the radius of curvature of bending deformation is smaller (inside the coil body) While the adjacent lines are in close contact with each other, there is a gap between adjacent lines of the coil body on the side with the larger radius of curvature (outside the coil body). On the other hand, when the coil body comprising the multi-strands of Example 2B is used, each metal element wire of the coil body comprising a large number (26 in this embodiment) when bent is deformed between adjacent lines. Thus, the gap between adjacent lines of the coil body on the side with the larger curvature radius (outside of the coil body) does not open a large gap like the single filament. Accordingly, even when the compression force due to the operation force of the operation rope is received, the loss of the operation amount due to the existence of the gap between the adjacent lines can be reduced, and the responsiveness of the hand operation unit to the curved portion can be further improved. Because it can.

  In addition, since the medical endoscope 101 is washed with physiological saline into the flexible sheath after use, for example, when a silver-based eutectic alloy is used for the bonding member 7, the medical endoscope 101 is described above. Thus, blackening progresses due to the formation of silver sulfide and the like, and corrosion increases, and the bonding strength decreases with time. In order to prevent this, it is desirable to use a bonding member 7 made of a gold-based eutectic alloy. And if the connection base 8 or the curved portion 11b is the same as the coil body 5 or the same kind of material, no difference due to thermal expansion occurs between the joining members at the time of joining, and the wettability is made uniform between the joining members. This is a more desirable form because it can be firmly bonded. The same kind of material here refers to the same kind of material as long as the prefix is the same material regardless of any of the steel type symbols in the JIS display (whether SUS304 or SUS403).

Next, FIGS. 6 and 7 show a medical treatment instrument 102 of an application example including any one of the medical coil structures 1 to 3.
FIG. 6 shows a medical forceps 102A, which is a medical treatment instrument 102, and FIG. 6A shows a distal treatment section 1c, which is attached to the distal end portion of the operation rope 9c connected to the hand operation section 3c. A connection base 8, which is a substantially cylindrical connecting member for connecting a pair of forceps cups with a biopsy forceps 2 c having a pantograph mechanism, connects one end of the coil body 5 with the operation rope 9 c inserted thereinto and the joining member 7. It joins by the fixed width | variety (L1) in the longitudinal direction, and the junction part 6 is formed.
The figure (b) shows the hand operation part 3c, which is connected to the operation part main body 4c having a guide groove and a finger ring (not shown) and the hand part of the operation rope 9c. The slider 11c is provided with a cylindrical connecting member 10c. A connection base 8 is provided on the distal end side of the operation portion main body 4c, and the connection to the other end of the coil body 5 through which the operation rope 9c is inserted. The base 8 is joined with a constant width (L1) in the longitudinal direction using the joining member 7 to form the joint 6.

  Then, by moving the slider 11c in the front-rear direction (the left-right direction in the figure) along the guide groove, an operation force is applied to the operation rope 9c connected to the slider 11c, and the coil body 5 is operated by receiving this operation force. By supporting it as a reaction force, the forceps cup of the biopsy forceps 2c is opened (slider 11c is moved to the left side in the figure) and closed (slider 11c is moved to the right side in the figure) to supplement the affected area and perform treatment such as excision. The difference between the medical forceps and the medical hot biopsy forceps, which is a medical treatment instrument using high-frequency energization, is mainly due to the presence / absence of terminals to be joined to the high-frequency device and the presence / absence of insulation. The medical treatment tool of the present invention includes the medical hot biopsy forceps.

  Next, FIG. 7 shows a medical clip device 102B, which is a medical treatment instrument 102. FIG. 7A shows a distal treatment section 1d, and is attached to the distal end portion of the operation rope 9d connected to the hand operation section 3d. Is provided with a connection base 8 which can accommodate the clip 2d and can be moved forward and backward. The connection base 8 is fixed in the longitudinal direction by using one end of the coil body 5 penetrating the operation rope 9d and the joining member 7. Are joined at a width of 5 mm to form a joint 6. The figure (b) shows the hand operation part 3d, which is the same as the medical forceps 102A, and the other end of the coil body 5 is a connection base 8 (not shown) provided on the front end side of the hand operation part 3d. The same as in FIG. 6B) and the joining member 7 are used to join in the longitudinal direction with a constant width to form the joined portion 6.

  Then, the clip 2d of the distal treatment section 1d is inserted into the body while being accommodated in the introduction tube 10d, and then the slider section 11d of the hand operation section 3d is moved in the right direction in the drawing along the guide groove, thereby moving the slider 11d. An operating force is applied to the operating rope 9d joined to the inner connecting member 13d, and the coil body 5 receives the operating force and supports the operating reaction force, whereby the hook connected to the distal end of the operating rope 9d. Force is transmitted to the connection member 12d in the shape of the hook, and the clip 2d is detached from the connection member 12d in the shape of the hook and detached, and the affected part is supplemented to close the blood vessel to perform hemostasis treatment. In addition, FIG. (C) is a longitudinal sectional view showing a clip state of the blood vessel 14d by the clip 2d.

  The coil body 5 has the same configuration as that of Example 1D of the medical coil structure 1 similar to that of the medical endoscope 101 or the configuration of Example 2B of the medical coil structure 2. In addition, when the operating force is large, the surface pressure of the cross-sectional area of the operating reaction force received by the coil body is decreased. Therefore, the coil average diameter is increased, the coil average diameter is 1.72 mm, and the wire diameter is 0.7. Example 1E medical coil structure 1 having a configuration in which one wire of 26 mm is wound and formed, and 18 wires having an average coil diameter of 1.72 mm and a wire diameter of 0.26 mm are wound and formed, Alternatively, the length of the joining member 6 in the longitudinal direction is the same as that of each of the embodiments described above, and the medical coil structure 2 of Example 2C is used.

With this configuration, the coil body 5 made of a metal strand having a high strength tensile break strength can further improve the tensile break strength of the metal strand at the joint 6 by utilizing the heat of fusion of the joining member 7. In response to the operation force of the operation rope, the amount of contraction due to the compression of the coil body 5 that receives the compression force is reduced to reduce the loss of the operation amount, and as a result, the hand operation of the distal treatment section 1d with a small operation amount. Responsiveness can be improved. Furthermore, by using the medical coil structure 2 made of multi-strands, it is possible to further improve the rotational responsiveness to the distal treatment section 1d for hand operation.
The reason is as described above. In particular, the medical coil structure 2 is a preferred embodiment in the medical forceps for collecting a living tissue that needs to be rotated by being introduced to a desired position and the medical clip device for hemostasis.

8 and 9 show an ultrasonic diagnostic medical catheter 103 and an optical interference diagnostic medical catheter 104 of an application example including any one of the medical coil structures 1 to 4.
FIG. 8 shows an overall view of the diagnostic apparatus 1f, which includes diagnostic medical catheters 103 and 104, a scanner / pullback section 3f, and an operation control apparatus 2f including an LCD monitor, an operation panel, a main body control section, and the like. The pullback unit 3f and the operation control device 2f are connected by a signal line 4f.

FIG. 9 shows the diagnostic medical catheters 103 and 104. FIG. 9A is an overall view of the diagnostic medical catheters 103 and 104. A distal end portion 1e having a guide wire lumen from the distal end side, a catheter sheath 2e, and the like. The proximal side includes a connector portion 3e including a sheath connector 31e integrated with the catheter sheath 2e and a drive shaft connector 32e that rotatably holds the drive shaft 5e.
FIG. 2B is a longitudinal sectional view of the distal end side of the catheter sheath 2e of the ultrasonic diagnostic medical catheter 103, and the distal end portion is an ultrasonic transducer that functions as an ultrasonic transducer unit that transmits and receives ultrasonic waves. 81e is comprised of a housing 8e that is housed and held, and the housing 8e is joined by using a joining member 7 at the end of a drive shaft 5e that transmits a driving force for rotating the ultrasonic transducer 81e. A portion 6 is formed, and a signal line 9e is disposed in the drive shaft 5e and extends from the ultrasonic transducer 81e to the connector portion 3e.

And the drive shaft 5e consists of the structure in any one of the medical coil structures 1-4 of this invention. Further, the coil body 5 of each of the embodiments 1A to 1E or the like is partially joined to the end portion of the housing 5e by using the joining member 7 to provide the joint portion 6, and any of the medical coil structures 1 to 4. These structures may be used.
The medical coil structure 1 is Example 1E in which a single wire having an average coil diameter of 1.72 mm and a wire diameter of 0.26 mm is wound and formed. In addition, in order to improve the rotation transmission property to the tip portion, Example 2C of the medical coil structure 2 comprising 18 multi-strand wires having an average coil diameter of 1.72 mm and a wire diameter of 0.26 mm. It is.
And in order to obtain uniform rotation performance without causing left and right rotation unevenness, the outer layer coil body 51 has a coil average diameter of 0.96 mm, a wire diameter of 0.16 mm, and 16 winding forming or twisting configurations. The inner layer coil body 52 has a two-layer structure in which the coil average diameter is 0.64 mm, the wire diameter is 0.16 mm, and the 11 outer layer coil bodies 51 are wound or twisted in the opposite direction. It is Example 3A of the medical coil structure 3. FIG.
Further, in order to obtain higher rotation performance with uniform left and right rotation, Example 4A of the medical coil structure 4 having a three-layer structure is shown.

The difference between the ultrasonic diagnostic medical catheter and the optical interference diagnostic medical catheter is shown in FIG. 2B in which the tip of the ultrasonic diagnostic medical catheter functions as an ultrasonic transducer unit that transmits and receives ultrasonic waves. In contrast to the configuration of the housing 8e in which the acoustic wave oscillator 81e is housed and held, the distal end portion of the optical interference diagnostic medical catheter is a prism or mirror that functions as an optical probe that emits and receives low interference light ( This is the difference from the housing that houses and holds the other (not shown), and other configurations are the same as those of the ultrasonic diagnostic medical catheter.
That is, the proximal side of the flexible tube body is provided with a connector comprising a drive shaft connector connected to the operation control device of the diagnostic device, and the distal end side comprises a catheter sheath of a hollow tube body, and the catheter The sheath comprises a housing for storing and holding a device for drawing a tomographic image at the distal end, and the proximal side is provided with a drive shaft formed in a coil shape extending to the connector. In a diagnostic medical catheter for rendering an image, the drive shaft is formed using the medical coil structure according to any one of claims 1 to 6, or the housing or The medical coil structure according to any one of claims 1 to 6, wherein the medical coil structure has a joint part that is partly joined to the drive shaft connector part. A diagnostic medical catheter characterized by comprising a housing that holds and holds a device that renders tomographic images, and the housing that holds and holds an ultrasonic transducer that functions as a unit that transmits and receives ultrasound. In the case of a catheter for ultrasonic diagnostic medical use, or a housing that houses and holds a prism or mirror that functions as an optical probe for irradiating and receiving low interference light, it is an optical diagnostic medical catheter.

Next, in the medical coil structures 1 to 4, the diagnostic medical catheters 103 and 104 are medical coils that have high rotational transmission from the proximal side to the distal end side even in a bent state and do not cause rotational unevenness. The structure will be described.
FIG. 10 shows a medical coil structure twisting apparatus 10 according to the present invention, and FIG. 11 shows a process diagram of primary to tertiary molded bodies for manufacturing the coil body 5 of each of the above embodiments. Rotating the twisting device 10 at one end of the primary molded body 16a cut into a predetermined length after a plurality of metal wires are used on the outer periphery of the core wire 17 and twisted in a rope shape with a wire rope twisting machine. The primary molded body is fixedly set to the operation check 11 and the other end is slidable in the longitudinal direction of the primary molded body 16a, and a static load weight 13 having a predetermined weight is suspended between the slide type fixed checks 12. It fixes with the state which applied the tensile force to 16a. Then, the rotary operation chuck 11 and the slide type fixed chuck 12 are connected to each other by a conductive wire 15 from the current generator 14 so that each metal wire of the primary molded body 16a can be heat-treated by electric resistance heating.

  Then, a static load weight 13 of a predetermined amount to be described later is hung and the rotary chuck 11 is moved in the same direction as the twisting direction of the primary molded body 16a in a state where a tensile force is applied to the primary molded body 16a ( In FIG. 11, (a) symbol a) 20 times / m to 200 times / m, preferably 25 times / m to 180 times / m, more preferably 30 times / m to 150 times / m. Thereafter, 10% to 30%, more preferably 15% to 25%, and more preferably 20% of the twisting process in the direction opposite to the twisting direction (20 b in FIG. 11, (b) in the figure). This is the most desirable form.

The number of twists of the same twisting process as the twisting direction of the primary molded body 16a is set as the above range, and if it is within the above range, rotation unevenness is achieved under the condition that matches the setting range of the static load weight 13 described later. This is because a medical coil structure having a high degree of rotational transmission that does not generate the problem is obtained.
And although only twisting in the same direction as the twisting direction may be used, it is most preferable to apply the reverse twisting with the adjacent wire of the metal strand formed by twisting the primary molded body 16a. This is because the compressive stress generated locally is homogenized to obtain a medical coil structure with a high degree of rotational transmission.

And after that, during the twisting process, during the twisting process or after the twisting process, the temperature range of 180 ° C. to 495 ° C., or the metal strand of the primary molded body 16a of the austenitic stainless steel wire containing Mo Sometimes, an electrical resistance heating process is performed in a temperature range of 180 ° C. to 525 ° C.
The reason why the twisting process is performed simultaneously with or during the twisting process is that the effect of suppressing the occurrence of disconnection of the metal element wire is high at the time of the twisting process. It is suitable when the rate exceeds 90% and has a high tensile breaking strength of 94% to 99.5%, and which one is selected depends on the required tensile breaking strength characteristics of the metal wire of the medical coil structure It is arbitrarily selected by etc.

Then, after the core material 17 of the primary molded body 16a is extracted (FIG. 11, illustrated (B)) to form the coil body 5 of the secondary molded body 16b, the joining member 7 is used in the same manner as in the above embodiment. A medical coil structure partially having a joint 6 is provided. In such a case, after the core material 17 is extracted, the small piece body 18 formed by molding the resin film 19 with a synthetic resin such as polyurethane resin, polyamide resin, polyimide resin, fluorine resin having a melting temperature of 180 ° C. to 420 ° C. May be inserted into the secondary molded body 16 b (FIG. 11, illustrated (C)), and the joint member 7 may be melted to form the joint portion 6. The reason for using the small piece body 18 on which the resin coating 19 is formed is that the releasability between the joining member 7 and the core material at the joining portion 6 is improved, and the inner surface of the tertiary molded body 16c can be formed smoothly. It is.
In addition, the joining method in the joining portion 7 is that the rod-like joining member 7 is placed in the longitudinal direction of the outer peripheral portion of the secondary molded body 16b and then irradiated with a laser beam or the like to join the joining portion 6 in a narrow range in the longitudinal direction. After forming, the small piece body 18 may be extracted to form a medical coil structure.
In addition, similarly to the small piece body 18, using a core material with a resin coating formed on the outer periphery of the core material 17 of the primary molded body 16a, the outer periphery of the core material is wound and formed. Alternatively, the twisted primary molded body 16a may be formed by partially forming the joint portion 6 using the joining member 7 after twisting and electrical resistance heating, and then extracting the core material with the resin coating. .

  Next, FIG. 12 (a) is a diagram showing the results of the rotational performance test in the handling state shown in FIG. 12 (c) of the medical coil structure of the present invention, and when the proximal side is rotated every 90 degrees on the horizontal axis. , The vertical axis indicates the tip side following rotation angle, the symbol b indicates a case where the response to the rotation every 90 degrees on the hand side is slow and a lot of rotation unevenness occurs, On the contrary, the case where the response is fast and the occurrence of rotation unevenness is small is shown. The rotation unevenness referred to here is, for example, that when the medical coil structure is rotated in the guide pipe (illustrated (C)), it becomes difficult to rotate due to the resistance at the bent portion, and a torsion pool due to the rotation occurs in the coil body. When the hand side is further rotated, the twist pool is released at a time, and the tip side follow-up rotation angle greatly exceeds the hand side rotation angle (90 degrees), so that a uniform and uniform rotation performance is achieved. This is a phenomenon that cannot be obtained. And (b) shows the static load ratio (ratio of the static load weight W (kgw) to the tensile breaking force P (kgf) of the medical coil structure including the core material 17 before twisting to be described later on the horizontal axis ( %), The static load ratio (%) has a relationship of W / P × 100, and the vertical axis shows the response ratio. Here, the response ratio means a value obtained by dividing the total rotation angle on the hand side when the tip side following rotation angle is 90 degrees by 90 degrees of the tip side following rotation angle. When a, the total rotation angle on the hand side is 3 × 90 degrees and the response ratio is 3 (3 × 90 ÷ 90). The closer the response ratio is to 1, the higher the response and the rotation follow-up (or rotation transmission) Property) is high.

According to the figure (b), it is found that the responsiveness changes depending on the value of the static load ratio, and the static load ratio when the responsiveness is high is 3% to 40%, preferably 5% to 35%. Most preferably, it is 7% to 30%.
The reason for this is that if the static load ratio falls below the lower limit, the tensile force, shear stress, and compressive stress caused by the contact of adjacent wires are generated in a complicated manner in the longitudinal direction when the metal wires are twisted. It is difficult to eliminate the “undulation” that twists and turns by the twisting process and the low-temperature heat treatment, and if the static load ratio exceeds the upper limit, an excessive tensile force is generated and the compressive stress due to the contact between adjacent lines is high. It can be considered that the existence of the part and the low part becomes remarkable, and the part where the gap between the adjacent lines is large and the part is randomly generated to reduce the rotational follow-up, that is, to reduce the responsiveness. Because it can. The selection of the static load ratio is an important item in the twisting and low temperature heat treatment methods.

  In addition, the relationship between the range of the number of twists of the present invention (from 20 times / m to 200 times / m) and the range of the static load ratio (from 3% to 40% of the tensile breaking force) is the range of the static load ratio. In the A zone (indicated by the reference symbol A) in the low load range of 3% to 10%, the upper limit range of the number of twisting operations is preferably about 100 times / m to 200 times / m, and the range of the static load ratio is In the B zone (reference symbol B) in the high load region of 30% to 40%, the lower limit range of the number of twisting processes is preferably about 20 times / m to 100 times / m. Which is selected is arbitrarily selected according to the characteristics required for the medical coil structure. And the said medical coil structures 3 and 4 can be obtained by making the secondary molded object 16b or the tertiary molded object 16c based on the said construction method into a 2 layer structure and a 3 layer structure. In addition, it is desirable that the coil body having a two-layer or three-layer structure is formed into a two-layer structure or a three-layer structure and then partially joined using the joining member 7 to form the joint portion 6.

  In addition, Patent Document 3 describes a twisting method for a hollow stranded wire coil body, but there is a conflicting description regarding the relationship between the static load ratio and the rotation followability, and analysis is not possible. This is sufficient, and there is no disclosure of the twisting direction of the hollow stranded wire coil body during twisting. On the other hand, the twisting method of the present invention has also clarified this point and is also strong. Patent Document 3 does not describe the technical idea of the present invention that improves the tensile strength at break by using the heat of fusion of a joining member using a drawn metal wire.

The coil body construction method has been described as the most suitable method for improving the rotational follow-up property by twisting a predetermined amount while applying a tensile force with a constant static load weight. To a coil body that is wound around the outer periphery and contains a core metal, or a coil body that contains a core material that is twisted around the outer periphery of the core material, or a hollow coil body that is extracted from the core metal or core material Even if a low-temperature heat treatment at 180 ° C. to 525 ° C. is performed, it is possible to improve the rotational followability and the like while improving the tensile breaking strength of the metal wire of the coil body.
This is due to the above-mentioned temperature and tensile fracture strength characteristics (Fig. 3) of the austenitic stainless steel wire that has been subjected to strong wire drawing, and locally in each metal wire that has been wound or twisted. This is because it is possible to average the residual stress.

And the manufacturing method of the medical coil structure of this invention makes it a coil body using the metal strand with an element wire diameter of 0.014 mm to 0.300 mm, Then, it joins partially using a joining member, and is joined. In the method for manufacturing a medical coil structure provided with a portion,
The metal strands, drawing the whole cross sectional reduction ratio after processing solid solution is to the tensile strength at break 99.5% to 80% 200kgf / mm ² or more 450 kgf / mm ² or less by using the austenitic stainless steel wire Consisting of a process, or a wire drawing process and a low-temperature heat treatment process,
A twisting step in which the metal element wire is twisted on the outer periphery of the core material to form a rope body;
A step of conducting current through the rope body and setting it to a heat-treatable state by electric resistance heating; and a static load weight of 3% to 40% of the tensile breaking force of the rope body is suspended at one end of the rope body. Applying a tensile force;
A twisting process of 20 times / m to 200 times / m in the same direction as the twisting direction of the rope body, with the other end of the rope body applied with a tensile force;
Thereafter, a reverse twisting process of turning from 10% to 30% of the number of twists of the twisting process,
Simultaneously with the twisting process, during the twisting process, or after the twisting process, a heat treatment process by electrical resistance heating,
Using the joining member having a melting temperature of 180 ° C. to 495 ° C. after the core material of the rope body is extracted to form a hollow coil body, or austenite in which the metal strand contains Mo A stainless steel wire comprising a joining step of partially joining using the joining member having a melting temperature of 180 ° C. to 525 ° C., or a melting temperature of 180 ° C. after the heat treatment step by the electric resistance heating A bonding step of partially bonding using a bonding member having a melting temperature of 180 ° C. to 525 ° C. using a bonding member of 495 ° C. or when the metal strand is an austenitic stainless steel wire containing Mo; After that, the medical coil structure comprises a cored coil body process in which the core material of the rope body is extracted to form a hollow medical coil structure. It is a manufacturing method of a structure.
With this manufacturing method, a medical coil structure having a high degree of rotation transmission and rotation followability can be obtained. In particular, rotation unevenness including medical coil structures such as medical clip devices that require rotation performance is obtained. This is a preferred application example for an ultrasonic diagnostic or optical interference diagnostic medical catheter composed of a drive shaft that requires a high degree of rotational transmission without any interference.

Further, in the cored coil body step of the method for manufacturing the medical coil structure, the core material is formed of a core material in which a resin film having a melting temperature of 180 ° C. to 420 ° C. is formed on an outer peripheral portion. In addition, after the cored coil body step, a core material having a resin film having a melting temperature of 180 ° C. to 420 ° C. formed on the outer peripheral portion is inserted into the hollow coil body, and then the joining member is used. A method for manufacturing a medical coil structure, comprising: a step of partially bonding, and a step of extracting a core material on which the resin film is formed.
By this manufacturing method, the releasability from the core member 17 of the joining member 7 when forming the joint portion 6 is enhanced, and the medical coil structure having a uniform inner diameter is produced by smoothing the inner peripheral surface of the joint portion 6. can do.

[The invention's effect]
As described above, the medical coil structure of the present invention, and the medical treatment instrument using the medical coil structure, are formed by twisting using a plurality of metal strands having high tensile strength at the time of strong wire drawing. The heat of fusion of the eutectic alloy, which is a joint member having a coil body made of a metal wire having a high tensile breaking strength and having a melting temperature range matched with a temperature range in which the tensile breaking strength is improved by strong work drawing By utilizing the above, it is possible to firmly join the joint portion, the connection base, and the like while further improving the tensile breaking strength of the coil body.

  In addition, the diagnostic medical catheter using the medical coil structure of the present invention as a drive shaft can provide a high-quality tomographic image of the diagnostic imaging apparatus even at high speed rotation, and greatly contributes to rapid treatment. Can do. There are the above various effects.

1 Coil structure for medical use (Examples 1A to 1E)
2 Coil structure for medical use (Examples 2A to 2C)
3 Coil structure for medical use (Example 3A)
4 Coil structure for medical use (Example 4A)
DESCRIPTION OF SYMBOLS 5 Coil body 6 Junction part 7 Joining member 8 Connection cap 100 Medical guide wire 101 Medical endoscope 102A Medical forceps (medical treatment tool)
102B Medical clip device (medical treatment tool)
103 Ultrasonic diagnostic medical catheter 104 Optical interference diagnostic medical catheter

Claims (13)

In a medical coil structure provided with a joint portion formed by forming a coil body using a metal strand having a strand diameter of 0.014 mm to 0.300 mm and then partially joining using a joining member,
The metal element wire of the coil body is subjected to a solid solution treatment using an austenitic stainless steel wire, followed by wire drawing with a total area reduction of 80% to 99.5%, and a tensile breaking strength of 200 kgf / mm ² or more. 450 kgf / mm ² or less,
The joining member uses a eutectic alloy having a melting temperature of 180 ° C. to 495 ° C., or an eutectic having a melting temperature of 180 ° C. to 525 ° C. when the metal strand is an austenitic stainless steel wire containing Mo. Using alloys,
The medical device characterized in that the partially joined joint joins adjacent lines with a width of 1/20 to 30 times the outer diameter of the coil body in the longitudinal direction of at least one end of the coil body. Coil structure. The medical coil body structure according to claim 1,
The metal wire of the coil body is provided with a low temperature heat treatment of 180 ° C. to 495 ° C. after drawing and drawing, or when the metal wire is an austenitic stainless steel wire containing Mo, 180 ° C. to 525 ° C. A low temperature heat treatment is provided, and the wire drawing and the low temperature heat treatment are repeated as at least one set, and then the final wire drawing is provided, and the total area reduction ratio until the final wire drawing is 90% to 99.5. A coil structure for medical use characterized by The coil body of the medical coil structure is
Using 2 to 30 metal strands, wound around the outer periphery of the core bar, then pulling out the core bar and twisting a rope around the outer periphery of the hollow core or a core material The medical device according to any one of claims 1 to 2, which is a coil body made of a hollow multi-filament after the core material is extracted after being twisted to form a rope body. Coil structure. The coil body of the medical coil structure is
A coil body comprising a two-layer structure of the inner layer and the outer layer, wherein the inner layer and the outer layer are provided in close contact with the outer periphery of the inner layer, and the winding direction of the inner layer or the twisting direction is different;
Alternatively, the inner layer and the inner and outer peripheries of the middle layer are provided in close contact with the inner layer and the outer layer, and the winding direction of the middle layer, or the twisting direction, and the winding direction of the inner layer and the outer layer, or the twisting direction are The medical coil structure according to any one of claims 1 to 3, which is a coil body having a three-layer structure including different inner layers, middle layers, and outer layers.   5. The medical coil structure according to claim 1, wherein the coil body of the medical coil structure is a coil body that has been heat-treated at a low temperature of 180 ° C. to 525 ° C. 6. The coil body of the medical coil structure is
A rope body is formed by twisting the metal strands around the outer periphery of the core material,
Set the heat treatment state by electric resistance heating by conducting current to the rope body,
The other end of the rope body is applied 20 times / m in the same direction as the twisting direction of the rope body with a tensile force of 3% to 40% of the tensile breaking force of the rope body applied to one end of the rope body. After twisting 200 times / m from
Heat treatment is performed by electric resistance heating at 180 ° C. to 525 ° C. at the same time as the twisting process, during the twisting process, or after the twisting process. 5. The medical coil structure according to any one of claims 1 to 4, wherein the coil body is a coil body made of a hollow multi-filament by extracting the core material of the rope body. In the manufacturing method of the medical coil structure in which the wire diameter is 0.014 mm to 0.300 mm and the coil body is made into a coil body, and the joint member is partially joined using a joining member to provide a joint portion.
The metal strands, drawing the whole cross sectional reduction ratio after processing solid solution is to the tensile strength at break 99.5% to 80% 200kgf / mm ² or more 450 kgf / mm ² or less by using the austenitic stainless steel wire Consisting of a process, or a wire drawing process and a low-temperature heat treatment process,
A twisting step in which the metal element wire is twisted on the outer periphery of the core material to form a rope body;
A step of making the rope body conduct current and setting it to a heat-treatable state by electric resistance heating; and a static load weight of 3% to 40% of the tensile breaking force of the rope body is suspended from one end of the rope body. Applying a tensile force;
A twisting process of 20 times / m to 200 times / m in the same direction as the twisting direction of the rope body, with the other end of the rope body applied with a tensile force;
Thereafter, a reverse twisting process of turning from 10% to 30% of the number of twists of the twisting process,
Simultaneously with the twisting process, during the twisting process, or after the twisting process, a heat treatment process by electrical resistance heating,
Using the joining member having a melting temperature of 180 ° C. to 495 ° C. after the core material of the rope body is extracted to form a hollow coil body, or austenite in which the metal strand contains Mo A stainless steel wire comprising a joining step of partially joining using the joining member having a melting temperature of 180 ° C. to 525 ° C., or a melting temperature of 180 ° C. after the heat treatment step by the electric resistance heating A bonding step of partially bonding using a bonding member having a melting temperature of 180 ° C. to 525 ° C. using a bonding member of 495 ° C. or when the metal strand is an austenitic stainless steel wire containing Mo; After that, the medical coil structure comprises a cored coil body process in which the core material of the rope body is extracted to form a hollow medical coil structure. Manufacturing method of structure. In the cored coil body process,
8. The method for manufacturing a medical coil structure according to claim 7, wherein the core material is formed of a core material having a resin film having a melting temperature of 180 ° C. to 420 ° C. formed on the outer peripheral portion.   After the cored coil body step, a core material having a resin film having a melting temperature of 180 ° C. to 420 ° C. formed on the outer peripheral portion is inserted into the hollow coil body, and then partially joined using the joining member. 8. The method for manufacturing a medical coil structure according to claim 7, further comprising: a step of performing, and thereafter a step of extracting the core material on which the resin film is formed. The flexible sheath body is provided with a distal treatment section on the distal end side and a hand operation section on the hand side, and an operation rope connected to the distal treatment section and the hand operation section is inserted through the flexible sheath body. The distal end treatment portion includes a bending portion that connects a plurality of bending pieces, and connects the bending piece on the distal end side and the distal end portion of the operation rope, and operates the hand operation portion. In the medical endoscope in which the bending portion is bent and deformed by the transmission action of the operation force of the operation rope,
The coil body in the flexible sheath body is formed using the medical coil structure according to any one of claims 1 to 6, or is bonded to at least one end of the coil body using the bonding member. A medical endoscope comprising a medical coil structure according to any one of claims 1 to 6, wherein the medical coil structure is formed to have a joint part or a joint part partially joined to the bending piece. . A flexible tube having a coil body is provided with a distal treatment section on the distal side and a hand operation section on the hand side, and an operation rope inserted through the coil body is connected to the distal treatment section and the hand operation section. In the medical treatment instrument for operating the distal treatment section by transmitting the operation force of the operation rope by pushing, pulling, or rotating the hand operation section,
The coil body of the flexible tubular body is formed using the medical coil structure according to any one of claims 1 to 6, or is joined to at least one end of the coil body using the joining member. A medical treatment instrument comprising the medical coil structure according to any one of claims 1 to 6, which has a joint part that is partially joined to the connection base. The proximal side of the flexible tube is provided with a connector comprising a drive shaft connector connected to the operation control device of the intravascular ultrasonic diagnostic apparatus by a signal line, and the distal end side is constituted by a catheter sheath of a hollow tube, The catheter sheath includes a housing that houses and holds an ultrasonic transducer that functions as a transducer for transmitting and receiving ultrasonic waves, and a proximal side includes a drive shaft that extends to the connector and is formed in a coil shape. In the ultrasonic diagnostic medical catheter that renders a tissue image in the body cavity by rotating the drive shaft,
The said drive shaft is comprised using the medical coil structure as described in any one of Claims 1-6, or the joining partially joined to the said housing or the said drive shaft connector using the said joining member. An ultrasonic diagnostic medical catheter comprising the medical coil structure according to any one of claims 1 to 6 having a portion. The proximal side of the flexible tube is provided with a connector consisting of a drive shaft connector connected to the operation control device of the optical coherence tomography diagnostic apparatus by a signal line, and the distal end side is composed of a catheter sheath of a hollow tube, The catheter shaft has a housing that houses and holds a prism or mirror that functions as an optical probe for irradiating and receiving low-interference light within the catheter sheath, and the drive shaft is formed in a coil shape with the hand side extending to the connector An optical interference diagnostic medical catheter for rendering a tissue image in a body cavity by rotation of the drive shaft,
The said drive shaft is comprised using the medical coil structure as described in any one of Claims 1-6, or the joining partially joined to the said housing or the said drive shaft connector using the said joining member. An optical interference diagnostic medical catheter comprising the medical coil structure according to any one of claims 1 to 6 having a portion.

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