JP6047773B1 - Assembly of medical guide wire and layer diagnostic imaging catheter used for diagnostic imaging catheter, and assembly of optical coherence tomographic diagnostic apparatus - Google Patents

Abstract

When taking a tomographic image of a lesion using a catheter for diagnostic imaging, a dark back shadow with low brightness due to a medical guide wire appears in the tomographic image. If the back shadow is to be reduced, the outer diameter of the medical guide wire must be further reduced. On the other hand, if the diameter is reduced, the mechanical strength characteristics of the medical guide wire are greatly reduced. This conflicting technical problem exists. The mechanical strength characteristics of a medical guide wire satisfy the ranges of both the torsional rigidity ratio of the core wire and the back shadow in the tomographic image by considering the surface area ratio of the core wire to the coil body. By doing so, conflicting technical problems can be overcome. [Selection] Figure 2

Description

  The present invention relates to a medical guide wire and the like used for a diagnostic imaging catheter when treating a lesion in a body cavity.

  Conventionally, when treating a lesion in a body cavity such as a blood vessel or an organ, for example, in order to obtain a tomographic image of the blood vessel, a medical guide wire (hereinafter referred to as a guide wire) is inserted into the blood vessel, and then the guide wire is used as a route guide. A diagnostic catheter is introduced to the lesion. Then, while rotating the probe provided in the catheter sheath on the distal end side of the diagnostic imaging catheter, the probe is retracted by a certain distance to the proximal side (rear end side) (pullback operation), and a tomographic image of the lesion is photographed. The surgeon diagnoses and treats the lesion based on the image.

  In such a case, in the tomographic image of the lesion, dark back shadows (or artifacts, collectively referred to as back shadows) generated by blocking the signal from the probe by the guide wire appear. In some cases, the back shadow covers the tomographic image of the vascular wall in the lesion area with a dark color, and it is difficult for the operator to accurately recognize the symptom of the lesion area from the tomographic image.

In Patent Document 1, a tubular guide wire insertion portion through which a guide wire is inserted is arranged at the distal end portion of a catheter main body having a lumen, and a shaft in the lumen of the catheter main body is rotated and retracted to the proximal side, so that light is transmitted. A catheter assembly for obtaining a tomographic image of a blood vessel by transmission / reception is disclosed.
In such a case, since the guide wire blocks light, back shadow occurs. In order to solve this problem, a guide wire including a tubular body of a light transmitting member on the distal end side of the guide wire is described.

  In Patent Document 2, a metal outer coil having a total length of 300 mm from the front end to the rear end side and an outer diameter of about 0.360 mm at the front end portion, a total length of 50 mm from the front end to the rear end side, and an outer diameter of about 0.1 mm. A guide wire consisting of a two-layer coil with a 190 mm metal inner coil is described.

WO2011 / 114600 Publication JP2013-162920A

  In the guide wire described in Patent Document 1, the tubular light transmitting member is made of a light transmitting resin material or a glass material. The light-transmitting resin material has higher flexibility than the metal material but has extremely low torsional rigidity, and the torsional angle increases extremely as the torsional rigidity decreases. In addition, the glass material has a certain degree of rigidity as compared with the metal material, but the elongation is extremely low and is brittle. When a torsion force is applied, the glass material tends to be twisted and broken.

In the guide wire described in Patent Document 2, a metal outer coil having a total length of 300 mm and an outer diameter of about 0.360 mm is arranged at the front end portion from the front end to the rear end side. In this case, in order to take a tomographic image, an outer coil having a large outer diameter (about 0.360 mm) exists within a range in which a probe, which will be described later, retreats to the hand side (rear end side). A signal from the probe is blocked over the entire range where the outer coil having a diameter recedes, and a large back shadow corresponding to a large dark outer diameter caused by the outer coil appears in the tomographic image.
Furthermore, since the inner coil is provided inside the outer coil, a strong dark-colored back shadow with even lower brightness appears in the tomographic image.

  And in either of Patent Documents 1 and 2, while using a metal material for the core wire of the guide wire, taking advantage of the excellent mechanical strength characteristic of the metal material, maintaining the passage through the lesion, and the guide wire No technical idea for reducing the back shadow in the tomographic image due to the above is described. This presents an important technical problem in recognizing accurate lesion symptoms from tomographic images.

  The present invention has been made in view of the above technical problem, and reduces back shadow in a tomographic image while maintaining the passage of a guide wire through a lesioned part, and is accurate based on a sharpened tomographic image. An object of the present invention is to provide a guide wire or the like that can recognize a symptom of a lesion.

In order to achieve the above-described object, the guide wire or the like according to the present invention inserts the rear end of the guide wire disposed in the lumen into a cylindrical guide wire insertion portion provided at the distal end of the diagnostic imaging catheter. Then, the diagnostic imaging catheter is introduced into the lumen along the guide wire.
On the rear end side with respect to the guide wire insertion portion, the probe provided in the sheath of the diagnostic imaging catheter is moved backward while rotating to obtain a tomographic image of the living tissue.

The guide wire includes a first core wire in which the core wire has pseudoelastic characteristics, and the first core wire includes, from the rear end to the front end, a core wire rear end large diameter portion, a core wire intermediate small diameter portion, and a core wire front end small diameter portion, It has a portion that gradually changes in diameter from the rear end side to the front end side. The core wire tip diameter small portion is disposed in a coil body having an equal diameter portion.
A tip joint portion that joins the tip of the coil body and the tip of the core wire tip diameter small portion, and a rear end joint portion that joins the rear end of the coil body and the rear end side of the core wire tip diameter small portion.

The torsional rigidity ratio of the core wire intermediate small diameter part to the core wire rear end large diameter part (torsion rigidity of the core wire intermediate small diameter part / torsion rigidity of the core wire rear end large diameter part) is 0.06565 or more and 0.3735 or less.
A cylindrical body obtained by connecting the maximum outer diameters of the equal-diameter portions of the coil body with a virtual line is defined as a virtual coil cylindrical body, and the surface area ratio of the core intermediate thin diameter portion to the virtual coil cylinder (surface area of the core intermediate thin diameter portion / virtual coil cylinder) The surface area of the body is 0.506 or more and 0.781 or less .
A medical guide wire used for a diagnostic imaging catheter has a hydrophilic film formed on at least the outer periphery of the core intermediate thin diameter portion. The diagnostic imaging catheter is an optical diagnostic tomographic catheter having an optical probe that transmits and receives low interference light having a wavelength of 0.75 μm or more and 1.4 μm or less. It is an assembly of a medical guide wire and a diagnostic imaging catheter .

  The core intermediate thin diameter portion has a circular cross section and an equal diameter over the entire length in the longitudinal direction, and is located at 30 mm or more and 200 mm or less from the front end to the rear end side of the front end joint portion.

  The core wire of the guide wire includes a first core wire having pseudo-elastic characteristics on the front end side, a second core wire having a second core wire diameter large portion of an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side, A connecting portion connecting the rear end side of the first core wire and the front end side of the second core wire;

  Torsional rigidity ratio of the second core wire diameter large portion of the second core wire to the core wire rear end large diameter portion of the first core wire (torsional rigidity of the second core wire large diameter portion of the second core wire / core wire rear end diameter large portion of the first core wire Torsional rigidity) of more than 1 and 5 or less.

  The connection of the connecting portion is a connection by brazing or welding joining the rear end of the first core wire and the tip of the second core wire.

The first core wire includes a rear end connection diameter small convex portion at the rear end, and the second core wire includes a front end connection diameter small convex portion at the front end.
The connecting portion is connected to the inner side of the tubular member having pseudo-elastic properties by inserting the rear end connecting diameter small convex portion of the first core wire from one side, and the leading end connecting diameter small convex portion of the second core wire from the other side. Is inserted, and the tubular member, the rear end connection diameter small convex portion, and the front end connection diameter small convex portion are connected by either one or both of adhesive bonding and welding bonding.

  The optical coherence tomography diagnostic apparatus has a scanner that pulls back the optical probe while rotating it, a pullback unit, and an operation control device that processes measurement data from the optical probe and displays an image. It is an assembly of a medical guide wire used for an imaging diagnostic catheter, an imaging diagnostic catheter, and an optical coherence tomographic imaging apparatus.

The guide wire used for the diagnostic imaging catheter of the present invention includes a first core wire whose core wire has pseudoelastic characteristics, and the first core wire has a large rear end diameter portion and a middle intermediate diameter portion of the core wire from the rear end to the front end. A core wire tip diameter small portion.
The core wire intermediate small diameter portion has a torsional rigidity ratio of the core wire intermediate small diameter portion to the core wire rear end large diameter portion (torsion rigidity of the core wire intermediate thin diameter portion / torsion rigidity of the core wire rear end large portion) of 0.06565 or more. 3735 or less.
A cylindrical body in which the small diameter portion of the core wire is inserted into a coil body having an equal diameter portion, and the maximum outer diameter of the equal diameter portion of the coil body is connected by a virtual line is defined as a virtual coil cylindrical body, and the core wire intermediate to the virtual coil cylindrical body The surface area ratio of the small diameter part (surface area of the core wire intermediate small diameter part / surface area of the virtual coil cylindrical body) is 0.506 or more and 0.781 or less .
The reason for this is, guide the mechanical strength properties of the core wire of the wire, in order to increase the particular torsional rigidity, it is necessary to increase the thickened by secondary section polar moment the outer diameter of the core wire. On the other hand, if the outer diameter of the core wire is increased, a dark back shadow with low brightness due to the guide wire will appear more enlarged in the tomographic image, leading to oversight of the symptom of the surgeon's lesion and misleading diagnosis. There are conflicting technical issues.
As a result of many experiments, we focused on the “torsional rigidity ratio” for the mechanical strength characteristics of the intermediate thin diameter part of the core wire and the “surface area ratio” for the back shadow in the tomographic image. This is because it has been found that the conflicting technical problems can be overcome by satisfying both the ranges of “rigidity ratio” and “surface area ratio”.
Further, the guide wire used for the diagnostic imaging catheter has a hydrophilic film formed on at least the outer periphery of the core wire middle thin diameter portion. The diagnostic imaging catheter is an optical diagnostic tomographic catheter having an optical probe that transmits and receives low interference light having a wavelength of 0.75 μm or more and 1.4 μm or less. It is an assembly of a guide wire and a diagnostic imaging catheter.
An optical coherence tomographic imaging catheter using a wavelength of 0.75 μm or more and 1.4 μm or less is used as the imaging diagnostic catheter because light absorption by water in the living body is extremely small, and the invasiveness of light to living tissue This is because (photon energy of light, X-ray, etc.) is extremely low.
As a result, the hydrophilic coating formed on the outer periphery of the core wire intermediate small diameter portion absorbs water and swells, and even if the film thickness increases, the light absorption by water is very small, so the increased film thickness is added. The dark back shadow never expands. The swellability can be drastically improved by lowering the coefficient of dynamic friction with the swollen hydrophilic coating.

The core intermediate thin diameter portion has a circular cross section and an equal diameter over the entire length in the longitudinal direction, and is located at 30 mm or more and 200 mm or less from the front end to the rear end side of the front end joint portion.
The reason for this is to arrange the core wire intermediate small diameter portion within the range where the probe is retracted within the range where the tomographic image is taken, and to reduce the surface area of the core wire intermediate small diameter portion, resulting from the guide wire. This is because the dark image of the back shadow is reduced and reduced.

The core wire of the guide wire includes a first core wire having pseudo-elastic characteristics on the front end side, a second core wire having a second core wire diameter large portion of an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side, A connecting portion connecting the rear end side of the first core wire and the front end side of the second core wire;
Torsional rigidity ratio of the second core wire diameter large portion of the second core wire to the core wire rear end large diameter portion of the first core wire (torsional rigidity of the second core wire large diameter portion of the second core wire / core wire rear end diameter large portion of the first core wire Torsional rigidity) of more than 1 and 5 or less.
The reason for this is that a work-induced martensitic transformation phase having a lower transverse elastic modulus than the stainless steel wire and a lower torsional rigidity and a higher torsional rigidity and a higher transverse elastic modulus than the first core wire is provided on the rear end side of the first core wire. This is because the second core wire made of an austenitic stainless steel wire is connected to supplement the improvement of the rotation transmission to the tip side of the first core wire.

The connection of the connecting portion is a connection by brazing or welding joining the rear end of the first core wire and the tip of the second core wire.
The reason is that the outer diameter of the connecting portion is prevented from being increased, the slidability with the diagnostic imaging catheter or the like is smoothed at the connecting portion, and the first core wire has a low transverse elastic modulus and low torsional rigidity. This is because the second core wire having a high transverse elastic coefficient and high torsional rigidity is connected to the rear end side of the rear end side to supplement the improvement of the rotation transmission to the front end side of the first core wire.

The first core wire includes a rear end connection diameter small convex portion at the rear end, and the second core wire includes a front end connection diameter small convex portion at the front end.
The connecting portion is connected to the inner side of the tubular member having pseudo-elastic properties by inserting the rear end connecting diameter small convex portion of the first core wire from one side, and the leading end connecting diameter small convex portion of the second core wire from the other side. Is inserted, and the tubular member, the rear end connection diameter small convex portion, and the front end connection diameter small convex portion are connected by either one or both of adhesive bonding and welding bonding.
The reason for this is to prevent the concentration of torsional stress at the connection part due to the difference in the transverse elastic modulus from the second core wire with high torsional rigidity to the first core line with low torsional rigidity, and torsional deformation at the connection part, and By connecting a second core wire having a high transverse elastic modulus and a high torsional rigidity to the rear end side of the first core wire having a low transverse elastic modulus and a low torsional rigidity, the transmission of rotation to the tip side of the first core wire is improved. It is for complementing.

The optical coherence tomography diagnostic apparatus has a scanner that pulls back the optical probe while rotating it, a pullback unit, and an operation control device that processes measurement data from the optical probe and displays an image. It is an assembly of a medical guide wire used for an imaging diagnostic catheter, an imaging diagnostic catheter, and an optical coherence tomographic imaging apparatus.
As a result, since a wavelength with very little light absorption by water in the living body is used, the light easily reaches the deep part of the living tissue, and the lubricating substance formed on the outer periphery of the core wire intermediate small diameter part of the guide wire With a hydrophilic coating, light absorption by water is extremely low, and as a result, the surgeon can obtain clearer tomographic images than conventional products and recognize the symptoms of the lesion, oversight of the lesion, misdiagnosis Etc. can be prevented.

1 shows an assembly of a medical guide wire and a diagnostic imaging catheter used in the diagnostic imaging catheter of the present invention. It is a principal part expansion partly notched side view of the front-end | tip part which shows the use condition of the assembly of FIG. 1 is a partially cutaway side view showing an entire first embodiment of a medical guidewire of the present invention. About the medical guide wire of this invention, the torsional rigidity ratio of the core wire intermediate | middle thin diameter part with respect to the core wire rear end large diameter part of a 1st core wire is shown. About the medical guidewire of this invention, the surface area ratio of the core wire middle thin diameter part with respect to a coil body is shown. FIG. 4 is a partially cutaway side view showing a rear end side of another embodiment of the medical guide wire of the present invention, in which (A) shows the second embodiment, and (B) shows the third embodiment. 1 shows an assembly of a medical guide wire, an optical coherence tomographic image diagnostic catheter, and an optical coherence tomographic image diagnostic apparatus used for the diagnostic imaging catheter of the present invention.

  Hereinafter, embodiments of the guide wire and the like of the present invention will be described.

  FIG. 1 shows an assembly of a guide wire and a diagnostic imaging catheter (hereinafter referred to as a catheter) used in the diagnostic imaging catheter of the present invention. FIG. 2 is an enlarged partial cutaway side view of a main part of a tip portion showing a use state of the assembly of FIG. 1. FIG. 3 is a partially cutaway side view showing the entire first embodiment of the guide wire of the present invention.

  An assembly 80 shown in FIG. 1 includes a guide wire 1 and a catheter 10 and is used in a living body lumen in an assembled state. Although the living body lumen is not particularly limited, it is assumed to be a blood vessel 200 in this embodiment. As shown in FIG. 1, the catheter 10 includes a long cylindrical catheter sheath 14 to be inserted into a blood vessel, a cylindrical guide wire insertion portion 12 for inserting the guide wire 1 into the distal end of the catheter sheath 14, and a surgical operation. It consists of a connector 13 arranged on the hand side (rear end side) for the user to operate.

  An imaging core 11 including a probe 11b that transmits and receives ultrasonic waves and a drive shaft 11c that transmits the rotational force of the probe 11b is inserted through the entire length of the catheter sheath 14 into the lumen of the catheter sheath 14.

  The connector 13 includes a sheath connector 13a integrally joined with the catheter sheath 14 and a drive shaft connector 13b that rotatably holds the drive shaft 11c. The drive shaft connector 13b is formed at the distal end imaging core 11 as indicated by an arrow in the drawing. At the same time, the scanner and pullback unit 102 (FIG. 7) can be used to move backward.

  FIG. 2 shows a state in which the distal end portion of the assembly 80 of the guide wire 1 and the catheter 10 is used in the blood vessel 200. The catheter 10 is inserted into the guide wire insertion portion 12 provided at the distal end of the catheter sheath 14 from the rear end of the guide wire 1, and the catheter 10 is disposed along the guide wire 1 at a lesion in the blood vessel.

  The probe 11b in the lumen of the catheter sheath 14 includes an ultrasonic transducer 11e and a housing 11d that holds the ultrasonic transducer 11e. The tomographic image of the living tissue is imaged by using the scanner and the pullback unit 102 to image the probe 11b provided in the catheter 10 while moving the probe 11b back to the rear end side while rotating it by the drive shaft 11c. 200 tomographic images are obtained. In such a case, the guide wire 1 is between the inner wall of the blood vessel 200 and the catheter sheath 14, and the guide wire 1 exists in the entire range in which the probe 11 b is retracted by a certain distance while being rotated. A dark back shadow of low brightness due to the guide wire 1 appears.

  FIG. 3 shows the entire guide wire 1 according to the first embodiment of the present invention. The guide wire 1 includes a rear end portion 1A, an intermediate portion 1B, and a front end portion 1C. The core wire, the coil body 3, and the fluororesin coating 5 And a lubricating coating 6. The core wire of the guide wire 1 of the first embodiment refers to the first core wire 2A on the front end side and the rear end connecting diameter small convex portion 27 on the rear end.

  The rear end portion 1A is provided with a connection portion 7 (FIG. 6) to extend the length in the longitudinal direction, and a rear end connection diameter small convex portion 27, and a core wire having the maximum outer diameter of the first core wire 2A on the rear end side. The intermediate portion 1B includes an intermediate first taper portion 22, an intermediate first constant diameter portion 23, an intermediate second taper portion 24, and a core wire intermediate small diameter portion 25 of the first core wire 2A. The tip portion 1C includes a tip end taper portion 26a of the first core wire 2A, a core tip end diameter small portion 26 including a tip first constant diameter portion 26b, the coil body 3, and the first core wire 2A and the coil body 3. A front end joint portion 4a and a rear end joint portion 4b to be joined are provided.

  The first core wire 2 </ b> A has a core wire rear end large diameter portion 21, a core wire intermediate small diameter portion 25, and a core wire front end diameter small portion 26, and has a portion that gradually changes from the rear end side to the front end side. In the coil body 3, the tip side of the tip first taper portion 26a of the core wire tip diameter small portion 26 and the tip first constant diameter portion 26b are inserted, and the tip of the coil body 3 and the tip first constant diameter portion are joined using a joining member. The tip end of the coil body 3 is joined to the rear end side of the tip first tapered portion 26a to form the tail end joined portion 4b. A cylindrical body in which the maximum outer diameter of the coil body 3 is connected by a virtual line (illustrated dotted line) indicates a virtual coil cylindrical body 30 (FIG. 3 (B)) described later.

  The fluororesin coating 5 is formed on the outer circumference of the core wire rear end large diameter portion 21 of the rear end portion 1A, the intermediate first taper portion 22, the intermediate first equal diameter portion 23, and the intermediate second taper portion 24 of the intermediate portion 1B. Yes. The lubricating coating 6 is formed at least on the outer periphery of the core wire intermediate small diameter portion 25 and the tip portion 1C (the rear end side of the tip first taper portion 26a, the coil body 3, and the tip joint portion 4a) of the intermediate portion 1B.

The core wire has a total length L0 of 1914 mm (the length of the first core wire 2A in the longitudinal direction is 1900 mm), the outer diameter D1 of the core wire rear end large diameter portion 21 of the rear end portion 1A is 0.3556 mm (0.014 inch), and the length The length L1 in the direction is 1500 mm.
The outer diameter D2 of the core wire intermediate small diameter portion 25 of the intermediate portion 1B is 0.225 mm, the length L2 in the longitudinal direction is 100 mm, and the length L3 from the tip of the tip joint portion 4a to the tip end portion of the core wire intermediate thin diameter portion 25. Is 50 mm. As shown in FIG. 2, the core wire intermediate small diameter portion 25 is located at least in a practical range (reference numeral L5) in which the probe 11b provided in the catheter 10 is retracted when taking a tomographic image of the blood vessel 200. The length L2 of 25 exceeds the length L5 in the practical range.
The outer diameters of the intermediate first tapered portion 22, the intermediate first equal diameter portion 23, and the intermediate second tapered portion 24 of the intermediate portion 1B are gradually changed from 0.3556 mm to 0.225 mm.
The length in the longitudinal direction of the tip first taper portion 26a of the tip portion 1C is 40 mm, the outer diameter gradually changes from 0.225 mm to 0.080 mm, and the outer diameter D3 of the tip first constant diameter portion 26b is 0. It has an equal diameter of 080 mm and a length in the longitudinal direction of 10 mm. Note that the first constant diameter portion 26b at the tip may be subjected to a pressing process on an equal diameter portion of the outer diameter D3 and the cross section may be rectangular.

For the first core wire 2A, a NiTi alloy, a NiTi alloy or the like having pseudoelastic characteristics is used. The pseudoelastic property here refers to an apparent elastic property generated by a mechanism such as twin deformation other than the elasticity caused by the change in atomic spacing, and includes a shape memory effect and superelasticity (transformation pseudoelasticity or twinning). Crystal pseudoelasticity).
Specifically, a superelastic metal (NiTi alloy) as found in JP-B-2-24548 and the like, a work-hardening type NiTi alloy as found in JP-B-6-83726, and the like, Japanese Patent Application Laid-Open No. 2001-164348 A wide-strain-range elastic NiTi-based alloy such as that disclosed in Japanese Patent Publication No. 2002-69555, and a linear elastic NiTi-based alloy such as that disclosed in Japanese Patent Application Laid-Open No. 2002-69555.
NiTi alloys having pseudoelastic properties, NiTi-based alloys include NiTi alloys with Ni of 48 at% to 52.0 at% and the balance of Ti, Ni containing 48 at% to 52.0 at%, and Cr, Fe, Co, NiTi alloy containing 0.05 at% to 3.0 at% of one or more of Mo, V, and Al with the balance being Ti, and 36.0 at% to 48.0 at% of Ni. Further, NiTi alloy or the like containing 5.0 at% to 12.0 at% of Cu and the balance being Ti.

The coil body 3 is formed by winding using a wire having a constant wire diameter with a wire diameter t1 of 0.060 mm. The coil body 3 is wound and formed with a minimum outer diameter A1 of 0.291 mm and a maximum outer diameter A2 of 0.3556 mm, and the length in the longitudinal direction is 35 mm. In addition, 10 mm on the rear end side of the coil body 3 is a tightly wound inclined portion 3 a that gradually increases and expands toward the front end side, and 25 mm on the front end side has an equal diameter with an outer diameter A2 of 0.3556 mm. The gap is a sparsely wound equal-diameter portion 3b having a wire diameter t1 of 1.20 times to 1.90 times.
The coil body 3 is a coil formed by winding a radiopaque wire containing tungsten, gold, platinum, doped tungsten, gold, platinum, nickel, or the like. Alternatively, the front end may be a radiopaque wire, and the rear end may be a coil formed by using a radiolucent wire such as a stainless steel wire.

The lubricating coating 6 may be a coating made of silicone oil or a hydrophilic coating made of a hydrophilic substance that exhibits lubricating properties when wet.
Examples of the silicone oil include dimethyl silicone oil, methylphenyl silicone oil, and reactive silicone oil, preferably reactive silicone oil. This is because the adhesiveness with the metal wire (core wire intermediate small diameter part 25, core wire tip small diameter part 26, coil body 3, etc.) is high.

  Examples of the hydrophilic substance for the hydrophilic coating include cellulose polymer substances such as carboxymethyl cellulose, maleic anhydride polymer substances such as methyl vinyl ether maleic anhydride copolymer, polyethylene oxide polymer substances such as polyethylene oxide, and polyvinylpyrrolidone. Such as acrylamide polymer materials. In addition, the swelling ratio of the hydrophilic film using a hydrophilic substance (percentage of the value obtained by subtracting the film thickness in the dry state from the film thickness in the swollen state) is 20% to 500%, and the higher the swelling rate (the hydrophilic property) There is a tendency that the thicker the water-based film is, the more the hydrophilic film is thickened and the slidability is improved.

  4 shows the “torsional rigidity ratio” of the first core wire 2A of the core wire with respect to the core wire rear end large diameter portion 21 in the guide wire 1 of the first embodiment of the present invention, and FIG. The “surface area ratio” of the small diameter portion 25 is shown.

When obtaining a tomographic image, since the guide wire 1 exists between the probe 11b retracting as shown in FIG. 2 and the inner wall of the blood vessel 200, a dark color with low brightness due to the guide wire 1 in the tomographic image is obtained. A back shadow appears.
In general, in order to improve the passability of the guide wire 1 at the lesioned part and the responsiveness to the surgeon, for example, it is necessary to increase the torsional rigidity among the mechanical strength characteristics of the first core wire 2A of the core wire, for example. In order to increase the torsional rigidity, it is necessary to increase the outer diameter of the first core wire 2A.
On the other hand, if the outer diameter of the first core wire 2A is made larger, the outer diameter of the coil body is increased accordingly, and the strong dark-colored back shadow caused by the guide wire is further enlarged in the tomographic image. Will appear. For example, in the guide wire of Patent Document 2, an outer coil having an outer diameter of about 0.360 mm and a length in the longitudinal direction of 300 mm is arranged on the distal end side, which means that the probe 11b moves backward during tomographic imaging. The outer coil is disposed beyond the practical range (L5 in FIG. 2) and the length L5. As a result, in the photographed tomographic image, a strong dark-colored back shadow with low brightness due to the outer coil having an outer diameter of about 0.360 mm appears.
For this reason, the present invention has focused on the “torsional rigidity ratio” for the mechanical strength characteristics and the “surface area ratio” for the back shadow in the tomographic image. And “surface area ratio” satisfy the predetermined range described later, and the present invention has found that conflicting technical problems can be overcome.

FIG. 4 shows the “torsional rigidity ratio” of the first core wire 2 </ b> A of the guide wire 1 with respect to the core wire rear end large diameter portion 21.
The horizontal axis indicates the position in the longitudinal direction of each part of the first core wire 2A of the guide wire 1, and the vertical axis indicates “each part of the first core wire 2A (reference numerals 21 to 21) relative to the core rear end diameter large portion 21 of the first core wire 2A. 26) ”.
Here, “the torsional rigidity ratio of each part (reference numerals 21 to 26) of the first core wire 2A” means each part (reference numerals 21 to 26) of the first core wire 2A with respect to the core wire rear end large diameter portion 21 of the first core wire 2A. ) Torsional rigidity ratio (torsional rigidity of each part / torsional rigidity of large diameter of rear end of core wire).
When the torsional rigidity of the core wire rear end large portion 21 is K1, the transverse elastic modulus is G1, the cross-sectional secondary pole moment is Ip1, and the outer diameter is D1, the cross-sectional secondary pole moment Ip1 of the core wire rear end large portion 21 is ( since represented by π × ^D1 4/32), the torsional rigidity K1 of the core rear large-diameter portion 21,
^{K1 = G1 × (π × D1} 4/32) ··· (1)
It can be expressed by the relational expression (1).

Next, assuming that the torsional rigidity of the core wire intermediate small-diameter portion 25 is K2, the transverse elastic modulus is G11, the cross-sectional secondary pole moment is Ip2, and the outer diameter is D2, the cross-sectional secondary pole moment Ip2 of the core wire intermediate thin-diameter portion 25 is from being represented by ^{(π × D2 4/32)} , the torsional rigidity K2 of the equation (1) as well as core intermediate small diameter portion 25,
^{K2 = G11 × (π × D2} 4/32) ··· (2)
It can be expressed by the relational expression (2).

Then, the torsional rigidity ratio K2 / K1 of the torsional rigidity K2 of the core wire intermediate small diameter part 25 to the torsional rigidity K1 of the rear end diameter large part 21 of the core wire (torsional rigidity of the intermediate small diameter part 25 of the core wire / (Torsional rigidity) is obtained from the relational expressions (1) and (2).
K2 / K1 = (G11 × D2 ⁴ ) / (G1 × D1 ⁴ ) (3)
It can be expressed by the relational expression (3).
Here, since the transverse elastic modulus G1 of the core wire rear end large diameter portion 21 and the transverse elastic modulus G11 of the core wire intermediate small diameter portion 25 are the same value with the same material and the same construction method, the torsional rigidity ratio K2 / K1 is ,
K2 / K1 = (D2 / D1) ⁴ (4)
It can be expressed by the relational expression (4).

In FIG. 4, reference numerals 21 to 26 indicate positions from the core wire rear end large diameter portion 21 to the core wire front end small diameter portion 26 of the first core wire 2 </ b> A. The torsional rigidity ratio K2 / K1 gradually decreases gradually from the core wire rear end large diameter portion 21 to the core wire intermediate small diameter portion 25, and suddenly increases beyond the core wire intermediate small diameter portion 25 and reaches the core wire tip small diameter portion 26. To drop. The torsional rigidity ratio K2 / K1 of the core wire intermediate small diameter portion 25 having the outer diameter D2 of 0.225 mm and the longitudinal length L2 of 100 mm is about 0.1603.
In addition to the “surface area ratio” described later, back shadow caused by the guide wire 1 during tomographic imaging is reduced while ensuring the torsional rigidity of the first core wire 2A, in particular, the core wire intermediate small diameter portion 25 to a minimum. Therefore, the torsional rigidity ratio K2 / K1 of the core wire intermediate small diameter portion 25 with respect to the core wire rear end large diameter portion 21 is 0.06565 (reference symbol X1) or more and 0.3735 (display symbol X2) or less, preferably 0. 0.0150 to 0.3324.

FIG. 5 shows a “surface area ratio” of the first core wire 2 </ b> A of the core wire with respect to the coil body 3 for the guide wire 1. The horizontal axis indicates the longitudinal position of each part of the first core wire 2A of the guide wire 1, and the vertical axis indicates the “surface area ratio” of the respective parts (reference numerals 21 to 26a) of the first core wire 2A with respect to the coil body 3.
The “surface area ratio” referred to here is a virtual coil cylinder when a cylindrical body in which the outer diameter of the maximum equal diameter portion of the coil body 3 is connected by a virtual line is used as the virtual coil cylinder 30 (FIG. 3B). The ratio of the surface area per unit length of each part to the surface area per unit length of the body (surface area per unit length of each part / surface area per unit length of the virtual coil cylinder), and below It is simply called “surface area ratio”. The maximum outer diameter A2 of the coil body 3 is 0.3556 mm, and the length in the longitudinal direction of the equal diameter portion 3b is 25 mm. The outer diameter of the virtual coil cylinder 30 is 0.3556 mm because the maximum outer diameter A2 of the coil body 3 is 0.3556 mm.

Assuming that the surface area per unit length of the virtual coil cylindrical body 30 is So (hereinafter simply referred to as surface area So) and the surface area per unit length of the core intermediate thin diameter portion 25 is S1 (hereinafter simply referred to as surface area S1), the virtual coil The surface area ratio of the core wire intermediate small diameter portion 25 to the cylindrical body 30 can be expressed by the relationship of S1 / So.
In the first embodiment of the present invention, since both the virtual coil cylinder 30 and the core wire intermediate small diameter portion 25 have a circular cross section, assuming that the unit length in the longitudinal direction is l, the outer diameter of the virtual coil cylinder 30 is Is A2, and the outer diameter of the core wire intermediate small diameter portion 25 is D2, the surface area ratio S1 / So of the core wire intermediate small diameter portion 25 with respect to the virtual coil cylindrical body 30 is
S1 / So = D2 / A2 (5)
It can be expressed by the relational expression (5).
In the present embodiment, the surface area ratio S1 / So can be expressed by an outer diameter ratio D2 / A2. The guide wire 50 according to the second embodiment and the guide wire 60 according to the third embodiment, which will be described later, have the same structure of the intermediate portion 1B and the tip portion 1C. The surface area ratio S1 / So of the portion 25 can be expressed by the relational expression (5).

In FIG. 5, reference numerals 21 to 26 a and 3 indicate the positions of the first core wire 2 </ b> A core wire rear end diameter large portion 21 to the tip first taper portion 26 a of the core wire tip diameter small portion 26 and the coil body 3.
The surface area ratio gradually decreases from the core wire rear end large diameter portion 21 to the core wire intermediate small diameter portion 25 and greatly increases when it exceeds a part of the rear end side of the core wire intermediate small diameter portion 25 and the core wire front end small diameter portion 26. To do. The surface area ratio S1 / So of the core intermediate thin diameter portion 25 having the outer diameter D2 of 0.225 mm and the longitudinal length L2 of 100 mm is 0.633. The lower the surface area ratio is, the darker back shadow is reduced and it is difficult to appear in the tomographic image.
In order to reduce the back shadow caused by the guide wire 1 in the tomographic image at the time of tomographic imaging while ensuring the torsional rigidity of the first core wire 2A to the minimum together with the “torsional rigidity ratio” described above, The surface area ratio S1 / So of the core intermediate thin diameter portion 25 with respect to the virtual coil cylinder 30 is not less than 0.506 (indicated by Y1 in the figure) and not more than 0.781 (indicated by Y2 in the figure), preferably not less than 0.534 and not more than 0.759. It is.

In the present invention, as shown in FIGS. 4 and 5, the torsional rigidity ratio of the core wire intermediate small diameter portion 25 of the first core wire 2A is set for the mechanical strength characteristic, and the back shadow in the tomographic image is set for “ By focusing on the “surface area ratio”, a number of experiments were repeated, and based on the results, both the “torsional rigidity ratio” and the “surface area ratio” were configured to satisfy the predetermined numerical range described above. Overcoming technical challenges.
That is, when both the “torsional rigidity ratio” and the “surface area ratio” satisfy the predetermined numerical range described above, the dark image of the back shadow caused by the guide wire 1 in the tomographic image at the time of tomographic imaging can be reduced. At the same time, it is possible to ensure the passage of the guide wire 1 at the lesion.

Next, as shown in FIG. 2, the core wire intermediate small-diameter portion 25 falls within a practical range (reference numeral L <b> 5) in which the probe 11 b included in the catheter 10 is retracted to capture a tomographic image at the time of tomographic imaging of a lesioned portion. It is located at least and is located in the range of 30 mm to 200 mm from the front end to the rear end side of the front end joint portion 4a of the guide wire 1. For example, the guide wire of Patent Document 2 has a metal outer coil having an outer diameter of about 0.360 mm and a length in the longitudinal direction of 300 mm from the front end to the rear end side. For this reason, the outer coil having a large outer diameter (outer diameter is about 0.360 mm) is located not only in the practical range in which the probe 11b takes a tomographic image but also moves backward, and is caused by the outer coil. The back shadow that appears is a strong dark image that appears in the tomographic image.
On the other hand, the guide wire 1 of the present invention has a metal outer coil (outer diameter of about 0.360 mm) as in Patent Document 2 within a practical range where the probe 11b is retracted during tomographic imaging. Rather, the core intermediate thin diameter portion 25 (the outer diameter D2 is 0.225 mm) of the first core wire 2A having a small outer diameter is located, and the outer diameter is about 40% lower than that of Patent Document 2. .
For this reason, the strong dark back shadow which appears in the tomographic image resulting from the guide wire 1 can be greatly reduced.

The core wire intermediate small diameter portion 25 of the guide wire 1 of the present invention has an outer diameter D2 of 0.225 mm, a circular cross section, and an equal diameter. The reason for this is to reduce the surface area and reduce the surface area ratio. Moreover, the core wire intermediate | middle thin diameter part 25 is provided in the range of 50 mm to 150 mm from the front-end | tip end of the front-end | tip junction part 4a, and the length L2 of a longitudinal direction is 100 mm. This is because the core wire intermediate small diameter portion 25 is at least located in a practical range (L5, see FIG. 2) in which the probe 11b provided in the catheter 10 is retracted during tomographic imaging in this range.
Then, considering the practical range in which the probe 11b provided in the catheter 10 is retracted during tomographic imaging, the core wire intermediate small diameter portion 25 is located 30 mm or more and 200 mm or less from the distal end of the distal joint portion 4a to the rear end side. Preferably it is.
Accordingly, the core wire intermediate small diameter portion 25 is located at least in a practical range where the probe 11b is retracted at the time of tomographic imaging, and is present beyond the practical range where the probe 11b is retracted in order to capture a tomographic image. Good (Fig. 2, reference L2). Moreover, the core wire intermediate small diameter portion 25 has a circular cross section, has an equal diameter over the entire length in the longitudinal direction, and is located 30 mm or more and 200 mm or less from the front end to the rear end side of the front end joint portion 4a.
Thereby, at the time of tomographic imaging, the core intermediate thin diameter portion 25 having a small diameter and a small surface area is disposed in a practical range where the probe 11b provided in the catheter 10 is retracted, and a dark image of the back shadow caused by the guide wire 1 is obtained. Can be reduced. The “equal diameter over the entire length in the longitudinal direction of the intermediate small-diameter portion 25” here means that tolerance is included. Specifically, it means that the allowable range of the outer diameter of both end portions is within ± 3% of the reference outer diameter dimension (outer diameter D2) with respect to the length in the longitudinal direction of the core wire intermediate small diameter portion 25.

Next, the structure of the junction part of the coil body 3 and the core wire tip small diameter part 26 is demonstrated.
The core wire tip diameter small portion 26 on the tip side of the core wire intermediate thin diameter portion 25 has a rear end outer diameter of 0.225 mm (corresponding to an outer diameter D2) and a tip outer diameter D3 of 0.080 mm from the rear end side to the tip side. The diameter gradually changes and the cross-sectional secondary pole moment also decreases.
As shown in FIG. 3 (b), the rear end of the coil body 3 is joined at the rear end joining portion 4b on the rear end side of the front end first taper portion 26a (in the first embodiment, the rear end joining portion 4b). The outer diameter of the tip first tapered portion 26a is about 0.171 mm), the closely wound inclined portion 3a having a length of 10 mm in the longitudinal direction from the rear end to the tip side, and the length in the longitudinal direction is 25 mm. This is a coil composed of an equidiameter portion 3b having an outer diameter of 0.3556 mm and a loose winding. The sparsely wound line gap of the equal diameter portion 3b is not less than 1.20 times and not more than 1.90 times the line diameter t1.

In the distal end portion 1C of the guide wire 1 of the present invention, the core wire of the core wire distal end small portion 26 joined at the rear end joined portion 4b gradually changes from the rear end side to the front end side with the rear end joined portion 4b interposed therebetween. As the diameter increases, the coil body 3 has a tightly wound inclined portion 3a that gradually increases in diameter from the rear end side to the front end side of the rear end joint portion 4b on the rear end side.
This is because, as the core wire of the core wire tip diameter small portion 26 gradually changes in diameter from the rear end side to the tip side, the cross-sectional secondary pole moment decreases, and the torsional rigidity on the tip side further decreases. This is because the coil body 3 having the densely wound inclined portion 3a compensates for the decrease in the cross-sectional secondary pole moment of the core wire tip diameter small portion 26.
As a result, further reduction in the torsional rigidity of the core wire tip diameter small portion 26 can be prevented, the rotational transmission force to the tip side can be supplemented by the coil body 3, and the fatigue resistance characteristics due to the torsion force can be improved. In addition, since the inclined portion 3a on the rear end side of the coil body 3 is located at the tip end face of the guide wire insertion portion 12 at the time of tomographic imaging, the guide wire insertion portion 12 can be closely fitted during bending deformation, and the guide wire 1 idleness can be reduced.

Next, FIG. 6 shows another embodiment of the guide wire according to the present invention. FIG. 6A shows the guide wire 50 of the second embodiment, and FIG. 6B shows the guide wire 60 of the third embodiment.
The guide wires 50 and 60 are connected to the second core wire (2B, 2C) using a stainless steel wire at the rear end side of the large core wire rear end diameter portion 21 of the guide wire 1 according to the first embodiment. Thus, the length of the longitudinal direction is extended. Note that the distal end portion 1C and the intermediate portion 1B of the guide wires 50, 60 have the same structure as that of the guide wire 1, and therefore are not shown. Also, the same reference numerals are assigned to the same structural members as the rear end portion 1A. It is.

The connecting portion 7 of the guide wire 50 includes a rear end of the core wire rear end large diameter portion 21 of the first core wire 2A of the guide wire 1 (not provided with the rear end connection diameter small convex portion 27) and a second end of the second core wire 2B. It has the joining part 71 which joined the front-end | tip of the core wire diameter large part 21B. The core wire of the guide wire 50 of the second embodiment indicates the first core wire 2A and the second core wire 2B.
The second core wire 2B has an outer diameter D4 of 0.3556 mm (same as the outer diameter D1 of the core wire rear end large diameter portion 21), a length L6 of 500 mm, and a rear end arc-shaped second core wire large diameter portion 21B, A fluororesin coating 5 is provided on the outer periphery of the two-core wire diameter large portion 21B. Further, the lubricating coating 6 is formed at least on the outer periphery of the core wire intermediate small diameter portion 25 of the intermediate portion 1B, as in the first embodiment. Preferably, the lubricating coating 6 using a hydrophilic coating is provided on the outer periphery of the intermediate portion 1B and the tip portion 1C, the outer periphery of the core wire rear end diameter large portion 21, and the outer periphery of the connection portion 7.
The reason for this is to improve the slidability of the diagnostic imaging catheter 10 inserted from the rear end of the guide wire 50, particularly at the connection portion 7.

The guide wire 50 is an austenitic stainless steel having a work-induced martensitic transformation phase having a larger transverse elastic modulus than that of the first core wire 2A at the rear end of the large core wire rear end diameter portion 21 of the first core wire 2A having pseudoelastic properties. A second core wire 2B made of a wire is provided.
The reason is that even if the length in the longitudinal direction is extended, the rotation transmission property from the rear end side to the front end side is prevented from being lowered and the rotation transmission property to the front end side is complemented.

Specifically, the torsional rigidity of the second core wire diameter portion 21B of the second core wire 2B made of an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side of the first core wire 2A is J1, and the transverse elastic modulus is G2, sectional secondary polar moment Ip3, when the outer diameter is D4, since the cross-sectional secondary polar moment Ip3 represented by ^{(π × D4 4/32)} , similarly to the equation (1), second J1 represents the torsional rigidity of the core wire diameter large portion 21B.
^{J1 = G2 × (π × D4} 4/32) ··· (6)
It can be expressed by the relational expression (6).
Since the torsional rigidity K1 of the large core wire rear end diameter portion 21 of the first core wire 2A is expressed by the relational expression (1), the second to the torsional rigidity K1 of the large core wire rear end diameter portion 21 of the first core wire 2A. Torsional rigidity ratio J1 / K1 of the torsional rigidity J1 of the second core wire diameter large portion 21B of the core wire 2B (torsional rigidity of the second core wire diameter large portion 21B of the second core wire 2B / core wire rear end large diameter portion 21 of the first core wire 2A Torsional rigidity) from the relational expressions (1) and (6),
J1 / K1 = (G2 × D4 ⁴ ) / (G1 × D1 ⁴ ) (7)
It can be expressed by the relational expression (7).

In the second embodiment, since the outer diameter D4 of the second core wire diameter large portion 21B and the outer diameter D1 of the core wire rear end large diameter portion 21 are both equal (both outer diameters are 0.3556 mm), the relational expression (7 )
J1 / K1 = G2 / G1 (8)
It can be expressed by the relational expression (8).
As can be seen from the relational expression (6) and the like, the torsional rigidity is proportional to the transverse elastic modulus, and the torsional rigidity increases as the value of the transverse elastic coefficient increases.
Accordingly, an austenitic stainless steel wire having a larger transverse elastic modulus than the first core wire 2A, rather than extending the length in the longitudinal direction of the core wire rear end large diameter portion 21 of the first core wire 2A having a low transverse elastic modulus. It is possible to prevent a decrease in rotation transmission from the rear end side to the front end side by extending the length using.
Further, by using the second core wire 2B made of an austenitic stainless steel wire having a work-induced martensitic transformation phase in which the transformation ratio to the martensite phase is increased in the austenitic stainless steel wire, the rear end side is obtained. Thus, it is possible to further prevent a decrease in rotation transmission from the tip to the tip side, and to complement the improvement in rotation transmission from the tip side.

And in order to obtain the 2nd core wire 2B of the austenitic stainless steel wire which has the processing induction martensitic transformation phase which increased the transformation ratio to the martensite phase by processing, the chemical composition of Ni and Cr of an austenitic stainless steel wire It becomes possible by specifying the amount and the processing rate (or total area reduction rate) of the reduced diameter drawing.
For example, when SUS304 is used, the addition amount of Ni and Cr is set near the lower limit of the JIS standard (8.00% to 8.20% compared to the standard value of Ni of 8.00% to 10.50%). Or 18.0% to 18.20% with respect to the standard value of Cr of 18.00% to 20.00%, or the Ni is 8.00% to 8.20% and the Cr is 18. 0% to 18.20% is used), and the reduction rate is 70% or more and 99.6% or less.
Thereby, the transformation rate to the martensite phase by processing can be 20% or more and 80% or less, and the transverse elastic modulus can be increased from 65000 Mpa to 69500 Mpa. The same applies to the case of using SUS316. For the austenitic stainless steel wire, the transverse elastic modulus can be improved by specifying the chemical component amounts of Ni and Cr and the processing rate.

When the austenitic stainless steel wire in which the chemical component amounts of Ni and Cr and the processing rate are specified is used, the transformation ratio to the martensite phase by processing is increased from about 40% to 80%. The transverse elastic modulus G2 of the second core wire 2B of the austenitic stainless steel wire having an induced martensitic transformation phase is from 68500 Mpa to 69500 Mpa, and the average value is 69000 Mpa.
Further, the transverse elastic modulus G1 of the NiTi alloy or the like of the first core wire 2A having pseudoelasticity is 17650 Mpa to 21575 Mpa when the austenite phase is exhibited at 40 ° C., and the average value is 19612.5 Mpa.

The first core wire 2A on the front end side is an austenitic stainless steel wire having pseudoelastic properties, such as NiTi alloy showing an austenite phase at 40 ° C., and the second core wire 2B on the rear end side having a work-induced martensite phase. In this case, the torsional rigidity ratio J1 / K1 of the torsional rigidity J1 of the second core wire diameter large portion 21B of the second core wire 2B with respect to the torsional rigidity K1 of the core wire rear end large diameter portion 21 of the first core wire 2A (the second core wire 2B first The torsional rigidity of the two-core-wire-diameter portion 21B / torsional rigidity of the core-wire rear-end large-diameter portion 21 of the first core wire) is 69000 Mpa, the average value of the transverse elastic modulus G2 of the second core-wire-diameter large portion 21B is large. Since the average value of the transverse elastic modulus G1 of the portion 21 is 19612.5 Mpa, the torsional rigidity ratio J1 / K1 of the average value is about 3.518 from the relational expression (8).
Based on many experimental results, the practical range of the transverse elastic modulus G2 of the second core wire diameter large portion 21B, in which the transformation ratio to the martensite phase by processing was increased, and the transverse direction of the core wire rear end large diameter portion 21 having pseudoelastic characteristics. Considering the practical range of the elastic modulus G1 together, the torsional rigidity ratio J1 / K1 of the second core wire diameter large portion 21B of the second core wire 2B to the core wire rear end large diameter portion 21 of the first core wire 2A exceeds 1 and 5 It is as follows.
The reason for this is that if the torsional rigidity ratio J1 / K1 is particularly less than 1, the torsional rigidity of the second core wire large diameter portion 21B on the rear end side becomes lower than the torsional rigidity of the core wire rear end large diameter portion 21 on the front end side. Even if the rear end side is rotated, twist accumulation due to the rotation operation is likely to occur on the rear end side, and the transmission of rotation to the front end side is reduced. If the torsional rigidity ratio J1 / K1 exceeds 5, the difference in torsional rigidity between the second core wire diameter large portion 21B on the rear end side and the core wire rear end large diameter portion 21 on the front end side becomes large, and the rear end side rotates. If it continues, it will become easy to generate | occur | produce a wave-like wave | undulation over the intermediate | middle part 1B etc. of diameter smaller than the core wire rear end diameter large part 21 and the core wire rear end diameter large part 21 on the front end side from the connection part 7. This is because the undulation comes into contact with the blood vessel wall or the inner wall of a device such as a catheter to increase the rotational resistance, and the rotational transmission to the distal end side decreases.
Preferably, the torsional rigidity ratio J1 / K1 is more than 1 and 4.5 or less, more preferably more than 1 and 4.0 or less.

  The connection part 7 forms the joining part 71 by brazing using a brazing material, or forms the joining part 71 using welding. As the brazing material, hard brazing such as gold brazing and silver brazing, or soft brazing such as Sn—Ag alloy is used. As welding, laser welding, electron beam welding or the like is used. Further, the length in the longitudinal direction of the joint portion 71 is approximately 0.1 mm to 2 mm.

The connecting portion 7 of the guide wire 60 has a small rear end connection diameter convex portion 27 having a circular cross section provided at the rear end of the first core wire 2A and a small front end connection diameter convex portion having a circular cross section provided at the front end of the second core wire 2C. The tubular member 72 is inserted and connected to the inside of the tubular member 72 so as to face each other. The core wire of the guide wire 60 of the third embodiment indicates the first core wire 2A, the rear end connection diameter small convex portion 27, the second core wire 2C, the front end connection diameter small convex portion 28, and the tubular member 72.
The second core wire 2C has dimensions (outer diameters D5 and D4, lengths L7 and L6) and the second core wire 2B of the guide wire 50 of the second embodiment, except that the tip connection diameter small convex portion 28 is provided at the tip. The same is true for the point that the fluororesin coating 5 is formed on the outer periphery of the second core wire diameter large portion 21C of the second core wire 2C.
The rear end connection diameter small convex portion 27 and the front end connection diameter small convex portion 28 have the same size and shape, the outer diameters d1 and d2 are about 0.240 mm, and the lengths l1 and l2 are 14 mm.

The tubular member 72 of the connecting portion 7 has an outer diameter do of about 0.350 mm, an inner diameter do1 of 0.250 mm, a length L8 of 30 mm, and is made of stainless steel or NiTi alloy. Preferably, similarly to the first core wire 2A, a NiTi alloy or a NiTi alloy having pseudoelastic properties is used.
The tubular member 72, the rear end connection diameter small convex portion 27, and the front end connection diameter small convex portion 28 are adhesively bonded using an adhesive such as a nitrile rubber. Alternatively, the outer periphery of the rear end connection diameter small convex portion 27, the outer periphery of the front end connection diameter small convex portion 28, and the tubular member 72 are welded together using means such as laser welding or electron beam welding. Further, both adhesive bonding and welding bonding may be used. The reason for this is that the tubular member 72, the rear end connection diameter small convex portion 27, and the front end connection diameter small convex portion 28 are bonded and bonded together in advance (possible by temporary bonding), so that the rear end connection diameter small convex portion 27 is welded. This is to prevent misalignment between the small tip connection diameter convex portion 28 and the tubular member 72, facilitate positioning of the welding operation, and facilitate production.

  The lubricating coating 6 is formed at least on the outer periphery of the core wire intermediate small diameter portion 25 of the intermediate portion 1B, as in the second embodiment. Preferably, the lubricating coating 6 (preferably a hydrophilic coating) is formed on the outer periphery of the intermediate portion 1B and the tip portion 1C, the outer periphery of the core wire rear end large diameter portion 21, and the outer periphery of the connecting portion 7 using the tubular member 72. The point of providing is also the same as in the second embodiment.

Similar to the second embodiment, the core wire of the guide wire 60 has a work-induced martensitic transformation phase having a larger transverse elastic coefficient than the first core wire 2A on the rear end side of the first core wire 2A having pseudoelastic characteristics. A second core wire 2C made of an austenitic stainless steel wire is provided.
The reason for this is that, as in the second embodiment, even when the length in the longitudinal direction is extended, the rotation transmission from the rear end side to the front end side is prevented from being lowered, and the rotation to the front end side is prevented. This is to complement the transmission.

The torsional rigidity of the second core wire diameter portion 21C of the second core wire 2C made of an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side of the first core wire 2A is J2, the transverse elastic modulus is G3, and the cross section secondary polar moment Ip4, when the outer diameter and D5, since the cross-sectional secondary polar moment Ip4 represented by ^{(π × D4 4/32)} , similarly to the equation (1), second core large diameter J2 is the torsional rigidity of the part 21C.
^{J2 = G3 × (π × D5} 4/32) ··· (9)
It can be expressed by the relational expression (9).
And since the torsional rigidity K1 of the core wire rear end large diameter portion 21 can be expressed by the relational expression (1), as in the relational expression (7), the torsional rigidity K1 of the core wire rear end large diameter part 21 The torsional rigidity ratio J2 / K1 of the torsional rigidity J2 of the two core wire diameter large portion 21C (the torsional rigidity of the second core wire diameter large portion 21C / the torsional rigidity of the core wire rear end large diameter portion 21) is:
J2 / K1 = (G3 × D5 ⁴ ) / (G1 × D1 ⁴ ) (10)
It can be represented by the relational expression (10).
Here, since the outer diameter D5 of the second core wire diameter large portion 21C and the outer diameter D4 of the core wire rear end large diameter portion 21 are the same, the torsional rigidity ratio J2 / K1 is:
J2 / K1 = G3 / G1 (11)
It can be expressed by the relational expression (11).
Furthermore, in the relational expression (11), since the transverse elastic modulus G3 of the second core wire diameter large portion 21C and the transverse elastic modulus G2 of the core wire diameter large portion 21B of the second embodiment are the same, the relational expression (11 )
J2 / K1 = G2 / G1 (12)
It can also be expressed as a relational expression (12).

Accordingly, as in the second embodiment, the torsional rigidity ratio J2 / K1 of the torsional rigidity J2 of the second core wire diameter large portion 21C of the second core wire 2C to the torsional rigidity K1 of the core wire rear end large diameter portion 21 of the first core wire 2A. The average value of the transverse elastic modulus G3 (same as the transverse elastic modulus G2) of the second core wire diameter large portion 21C is 69000 Mpa, and the average value of the transverse elastic modulus G1 of the core wire rear end large diameter portion 21 is 19612.5 Mpa. From the relational expression (12), it is about 3.518.
And, from many experimental results, the practical range of the transverse elastic modulus G3 of the second core wire large diameter portion 21C in which the transformation ratio to the martensite phase is increased by processing, and the core wire rear end large diameter portion 21 having pseudoelastic characteristics. Considering the practical range with the transverse elastic modulus G1, the torsional rigidity ratio J2 / K1 is more than 1 and less than or equal to 5, preferably more than 1 and less than or equal to 4.5, more preferably more than 1 and 4.0. It is as follows. Accordingly, this is the same as the second embodiment.

Next, the diagnostic imaging catheter 10 and the like will be described.
The above-described diagnostic imaging catheter 10 has been described as an ultrasonic diagnostic imaging catheter used in an intravascular ultrasonic diagnostic imaging apparatus. The diagnostic imaging catheter here is an optical coherent tomography used in an optical coherent tomographic imaging apparatus. A diagnostic imaging catheter is also included.
The main difference between the ultrasonic diagnostic imaging catheter and the optical coherence tomographic diagnostic catheter is that the ultrasonic diagnostic imaging catheter scans the probe 11b including the ultrasonic transducer 11e in the radial direction, whereas the optical imaging diagnostic catheter is optical. The catheter for coherent tomographic image diagnosis is that a probe incorporating an optical lens and an optical mirror is scanned in the radial direction, and the other basic structure is the same.

  As an image diagnostic apparatus, an intravascular ultrasound diagnostic apparatus (IVUS) inserts an ultrasound diagnostic imaging catheter with a probe into a blood vessel, and moves backward while rotating a probe containing an ultrasonic transducer. The reflected wave reflected by the living tissue is received by the same ultrasonic transducer, and a tomographic image of the blood vessel is drawn based on the intensity of the reflected wave.

As an image diagnostic apparatus, an optical coherence tomographic image diagnostic apparatus (OCT) has an optical lens and an optical mirror built in by inserting a catheter for optical coherence tomographic imaging in which a probe incorporating an optical lens and an optical mirror is arranged into a blood vessel. The apparatus is configured to receive a reflected light reflected by a living tissue by rotating the probe backward while rotating and drawing a tomographic image of a blood vessel based on the reflected light.
The optical coherence tomography diagnostic apparatus here includes an optical coherence tomography diagnostic apparatus (SS-OCT) using wavelength sweeping.
The main difference between the optical coherence tomography diagnostic apparatus and the optical coherence tomography diagnostic apparatus using the wavelength sweep is that the optical coherence tomography diagnostic apparatus uses low coherent light (several μm to several tens of μm), but the wavelength The optical coherence tomography diagnostic apparatus using sweeping is that a light source having a long wavelength (4 mm to 10 mm) is used and light having different wavelengths is continuously emitted, and other basic structures are the same as those of the optical coherence tomography diagnostic apparatus. It is.

Next, the assembly 80 of the guide wires 1, 50, 60 and the diagnostic imaging catheter 10 of the present invention will be described. The probe 11b provided in the catheter 10 is an optical probe incorporating an optical lens and an optical mirror for transmitting / receiving low-interference light, and for optical coherence tomographic image diagnosis using a wavelength of 0.75 μm to 1.4 μm. In the case of a catheter, the lubricating coating 6 on the outer periphery of the core wire intermediate small diameter portion 25 of the guide wire 1 disposed at least in a practical range where the probe 11b (optical probe) is rotated while rotating tomographic images, It is preferable to form a hydrophilic film made of the hydrophilic substance.
This is because, when the wavelength of the optical coherence tomographic imaging catheter is 0.75 μm or more and 1.4 μm or less, light absorption by water in the living body is extremely small, and light invasiveness to the living body is extremely low. It is. Moreover, it is because a sliding coefficient can be improved remarkably by making a dynamic friction coefficient low.
Accordingly, a hydrophilic film showing high lubrication characteristics when wet is formed on the outer periphery of the core intermediate thin diameter portion 25, and the hydrophilic film absorbs water and swells to near 500% to increase the film thickness. However, since light absorption by water is small, the increased film thickness is not added and the dark back shadow does not expand.
In addition, it is possible to provide guidewires 1, 50 and 60 used for diagnostic imaging catheters that can increase the swelling rate and lower the dynamic friction coefficient to dramatically improve the slidability. The hydrophilic film is not only the outer periphery of the core wire intermediate small diameter portion 25 but also the rear end side exposed from the coil body 3 of the first taper portion 26a of the tip end small diameter portion 26 and the coil body 3. It may be formed on the outer periphery.

  The assembly 80 of the guide wire 1, 50, 60 and the diagnostic imaging catheter 10 according to the present invention has at least the guide wire 1, 50, 60, 0,. It consists of an optical coherence tomographic diagnostic catheter provided with an optical probe 11b that transmits and receives low interference light of 75 μm or more and 1.4 μm or less, and a medical guide wire is inserted into the guide wire insertion part to obtain a tomographic image of a living tissue It is for getting.

FIG. 7 shows the diagnostic imaging apparatus 100. Since the basic structure is the same, the diagnostic imaging apparatus 100 includes an intravascular ultrasonic diagnostic imaging apparatus and an optical coherence tomographic diagnostic apparatus. Here, the diagnostic imaging apparatus 100 is described as an optical coherence tomographic image diagnostic apparatus (100).
The optical coherence tomographic image diagnosis apparatus (100) includes an operation control device 101 and a scanner and pullback unit 102. The operation control device 101 and a main body control unit 101a for processing measurement data, and an operation for inputting measurement values. A panel 101b and an LCD monitor 101c for displaying an image are provided. The scanner and pullback unit 102 is connected to an optical coherence tomographic catheter (catheter 10) including a probe 11b, and is connected to the operation control device 101 using a signal line 101d.

In the assembly of the guide wires 1, 50, 60, the catheter 10 and the diagnostic imaging apparatus 100 according to the present invention, the guide wire 1 used for the diagnostic imaging catheter has a hydrophilic coating (lubricant) on at least the outer periphery of the core wire intermediate small diameter portion 25. A conductive coating 6) is formed.
The imaging diagnostic catheter 10 is an optical coherence tomographic imaging diagnostic catheter (catheter 10) that includes an optical probe (probe 11b) that transmits and receives low-interference light and uses a wavelength of 0.75 μm to 1.4 μm. Then, the guide wire is inserted into the guide wire insertion portion 12 provided at the distal end of the catheter sheath 14 from the rear end of the guide wires 1, 50, 60, and is arranged along the guide wires 1, 50, 60 at the intravascular lesion. .
The optical coherence tomography diagnostic catheter (catheter 10) includes an operation control device 101 connected by a signal line 101d and a scanner and pullback unit 102 of the optical coherence tomography diagnostic device (100) including the scanner and pullback unit 102. Connecting.
The operation control apparatus 101 includes a main body control unit 101a that processes measurement data, an operation panel 101b that inputs measurement values, and an LCD monitor 101c that displays an image.
Then, a set of medical guide wires 1, 50, 60 used for the diagnostic imaging catheter 10, a diagnostic imaging catheter (optical coherence tomographic imaging catheter, catheter 10), and an optical coherent tomographic imaging apparatus (100). It is a solid.
Thereby, since a wavelength with less light absorption by water is used, light easily reaches the deep part of the living tissue and is formed on the outer periphery of the core wire intermediate small diameter part 25 of the guide wires 1, 50, 60. The hydrophilic film absorbs water and swells, and even if the film thickness increases, light absorption by water is small, so the increased thickness is not added and the dark-colored back shadow does not expand. High guidewires 1, 50, 60 can be provided. As a result, the surgeon can obtain a clearer tomographic image than the conventional product to confirm the lesion, and can reduce oversight of symptoms of the lesion, misdiagnosis, and the like.

If it supplements, although the medical guidewire used for the catheter for image diagnosis of this invention described the case where the transverse elastic modulus of the core wire rear end large diameter portion 21 and the core wire intermediate thin diameter portion 25 of the first core wire 2A is the same. For example, even if the same material is used, the transverse elastic modulus can be varied by partial heat treatment, surface strengthening (such as shot peening), or the like.
Moreover, when the connection part 7 which connected the rear end side of the 1st core wire 2A and the front end side of the 2nd core wire 2B is provided, the outer diameter D1 of the core wire rear end large diameter portion 21 of the first core wire 2A and the first Although the case where the outer diameter D4 of the second core wire diameter portion 21B of the two-core wire 2B is the same has been described, it may be different.
Considering such a case, the medical guide wire used for the diagnostic imaging catheters of claims 1 and 3 of the claims has the following contents. In addition, the code | symbol of the main components was attached in the parenthesis.

A. The content of the case of claim 1 "The rear end of the medical guide wire disposed in the lumen is inserted into a cylindrical guide wire insertion portion provided at the distal end of the diagnostic imaging catheter, and the diagnostic imaging is performed. After the catheter for catheter is introduced into the lumen along the medical guide wire, the probe provided in the sheath of the diagnostic imaging catheter is rotated behind the guide wire insertion portion while rotating the probe. A medical guide wire used in a diagnostic imaging catheter for obtaining a tomographic image of a living tissue by retracting to the end side,
The medical guidewire includes a first core wire (2A) in which the core wire has pseudoelastic characteristics,
The first core wire (2A) includes a core wire rear end large diameter portion (21), a core wire intermediate small diameter portion (25), and a core wire front end small diameter portion (26) from the rear end to the front end. A portion that gradually changes in diameter toward the distal end side, and the core wire distal end small diameter portion (26) is disposed in a coil body having an equal diameter portion;
A tip joint portion joining the tip of the coil body and the tip of the core wire tip diameter small portion (26), and a rear end of the coil body and the rear end side of the core wire tip diameter small portion (26) are joined. A rear end joint,
The torsional rigidity of the rear end diameter large portion (21) of the core wire is K1, the lateral elastic modulus is G1, the outer diameter is D1, the torsional rigidity of the intermediate intermediate diameter portion (25) is K2, the lateral elastic modulus is G11, the outer diameter. Let D2 be
Torsional rigidity ratio K2 / K1 of the core wire intermediate small diameter portion (25) to the core wire rear end large diameter portion (21) {Torsion rigidity of the core wire intermediate small diameter portion (25) / the core wire rear end large diameter portion (21 ) Torsional rigidity}
K2 / K1 = (G11 × D2 ⁴ ) / (G1 × D1 ⁴ )
0.065565 ≦ (K2 / K1) ≦ 0.3735 is satisfied, and
A cylindrical body in which the maximum outer diameter of the equal-diameter portion of the coil body is connected with a virtual wire is defined as a virtual coil cylindrical body, and a surface area ratio of the core intermediate thin diameter portion (25) to the virtual coil cylinder {the core intermediate intermediate diameter Surface area of the portion (25) / surface area of the virtual coil cylinder}
A medical guide wire used for a diagnostic imaging catheter, wherein the medical guide wire is 0.506 or more and 0.781 or less.

B. Content of the Case of Claim 3 The core wire of the medical guide wire is composed of a first core wire (2A) having pseudo-elastic characteristics on the distal end side and an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side. A connecting portion (7) in which a second core wire (2B) having a second core wire diameter large portion (21B), a rear end side of the first core wire (2A) and a front end side of the second core wire (2B) are connected. And
When the torsional rigidity of the second core wire diameter large portion (21B) is J1, the lateral elastic modulus is G2, and the outer diameter is D4,
Torsional rigidity ratio J1 / K1 of the second core wire diameter large portion (21B) with respect to the core wire rear end large diameter portion (21) {Torsion rigidity of the second core wire large diameter portion (21B) / the core wire rear end large diameter portion (21) Torsional rigidity}
J1 / K1 = (G2 × D4 ⁴ ) / (G1 × D1 ⁴ ),
1 <(J1 / K1) ≦ 5
The medical guide wire used for the diagnostic imaging catheter characterized by satisfying the following relational expression:

In addition, although the present invention has been described as a medical guide wire used for a diagnostic imaging catheter, the first core wire 2A on the distal end side and the rear end side are not limited to a medical guide wire used for a diagnostic imaging catheter. This can also be applied to a medical guide wire that is connected to the second core wire 2 </ b> B using the connecting portion 7.
In consideration of the above contents (when the transverse elastic modulus and the outer diameter are different), the following contents are obtained. In addition, the code | symbol of the main component site was appended in the parenthesis similarly to the above.
That means
“The medical guide wire is composed of a first core wire (2A) having a pseudoelastic property on the front end side and a second core wire diameter large portion of an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side ( 21B), and a connecting portion 7 connecting the rear end side of the first core wire (2A) and the front end side of the second core wire (2B),
The first core wire (2A) includes a core wire rear end large diameter portion (21) and a core wire front end small diameter portion (26) from the rear end to the front end, and a portion that gradually changes in diameter from the rear end side to the front end side. The core wire tip diameter small portion (26) is disposed in a coil body having an equal diameter portion, and a tip joint portion joining the tip of the coil body and the tip of the core wire tip diameter small portion (26); A rear end joint portion that joins the rear end of the coil body and the rear end side of the core wire tip diameter small portion (26);
The torsional rigidity K1 of the core wire rear end large portion 21 of the first core wire 2A, the lateral elastic modulus G1, the outer diameter D1, and the core wire large portion 21B of the second core wire 2B. When the torsional rigidity of J1 is J1, the lateral elastic modulus is G2, and the outer diameter is D4,
Torsional rigidity ratio J1 / K1 of torsional rigidity J1 of the second core wire diameter large part (21B) to torsional rigidity K1 of the rear end diameter large part (21) of the core wire {torsional rigidity of the second core wire diameter large part (21B) / The torsional rigidity of the rear end large diameter portion (21)} is
J1 / K1 = (G2 × D4 ⁴ ) / (G1 × D1 ⁴ ),
1 <(J1 / K1) ≦ 5
Is a medical guide wire characterized by satisfying the relational expression:
The same applies to the third embodiment.

  In the second embodiment, the longitudinal length L1 of the core core rear end large portion 21 of the first core wire 2A is 1500 mm, and the longitudinal length L6 of the second core wire large portion 21B of the second core wire 2B. However, the length L1 in the longitudinal direction of the core wire rear end large diameter portion 21 may be 500 mm, and the length L6 in the longitudinal direction of the second core wire large diameter portion 21B of the second core wire 2B may be 1500 mm. Set arbitrarily according to the site. The same applies to the third embodiment.

1 medical guide wire 2A first core wire (first embodiment)
2B 2nd core wire (2nd Embodiment)
2C 2nd core wire (3rd Embodiment)
3 Coil body 3a Inclined portion 3b Equal-diameter portion 4a Tip joint portion 4b Rear end joint portion 5 Fluorine resin coating 6 Lubricating coating 7 Connection portion 10 Diagnostic imaging catheter 11b Probe 11c Drive shaft 12 Guide wire insertion portion 21 Core wire rear end diameter Large part 21B Large part of the second core wire diameter (second embodiment)
21C 2nd core wire diameter large part (3rd Embodiment)
25 Core wire intermediate small diameter part 26 Core wire tip diameter small part 71 Joining part (2nd Embodiment)
72 Tubular member (third embodiment)
DESCRIPTION OF SYMBOLS 100 Image diagnostic apparatus 101 Operation control apparatus 102 Scanner and pull back part

Claims (6)

The medical guide wire disposed in the lumen is inserted into a cylindrical guide wire insertion portion provided at the distal end of the diagnostic imaging catheter, and the diagnostic imaging catheter is inserted into the medical guiding wire. And introduced into the lumen along the back of the guide wire, and retracted toward the rear end side while rotating the probe provided in the sheath of the diagnostic imaging catheter on the rear end side with respect to the guide wire insertion portion. An assembly of a medical guide wire and a diagnostic imaging catheter used in a diagnostic imaging catheter for obtaining a tomographic image of
The medical guide wire includes a first core wire having a pseudo-elastic property as a core wire,
The first core wire includes, from the rear end to the front end, a core wire rear end large diameter portion, a core wire intermediate small diameter portion, and a core wire front end small diameter portion,
Having a portion that gradually changes from the rear rule to the tip side, the core wire tip diameter small portion is disposed in the coil body having an equal diameter portion,
A tip joining portion joining the tip of the coil body and the tip of the core wire tip diameter small portion; and a rear end joint portion joining the rear end of the coil body and the rear end side of the core wire tip diameter small portion. Prepared,
The torsional rigidity ratio of the core wire intermediate small diameter portion to the core wire rear end large diameter portion (torsion rigidity of the core wire intermediate small diameter portion / torsion rigidity of the core wire rear end large diameter portion) is 0.06565 or more and 0.3735 or less. so,
A cylindrical body in which the maximum outer diameter of the equal-diameter portion of the coil body is connected with a virtual wire is defined as a virtual coil cylinder, and a surface area ratio of the core wire intermediate small diameter portion to the virtual coil cylinder (surface area of the core intermediate thin diameter portion) / the surface area of the imaginary coil cylinder) is state, and are 0.506 or 0.781 or less,
An optical interference comprising a hydrophilic coating formed at least on the outer periphery of the intermediate thin diameter portion of the core wire, and the diagnostic imaging catheter having an optical probe for transmitting / receiving low interference light having a wavelength of 0.75 μm or more and 1.4 μm or less assembly of the medical guidewire and imaging catheter used in diagnostic imaging catheter, wherein the catheter der Rukoto tomographic image for diagnosis. The said core wire intermediate | middle thin diameter part is located in 30 mm or more and 200 mm or less from the front-end | tip end of the said front-end | tip junction part to the rear end side with the same diameter over the full length of a longitudinal direction with a circular cross section. 2. An assembly of a medical guide wire and a diagnostic imaging catheter used in the diagnostic imaging catheter according to 1. The core wire of the medical guide wire has a first core wire having pseudo-elastic characteristics on the front end side and a second core wire diameter large portion of an austenitic stainless steel wire having a work-induced martensitic transformation phase on the rear end side. A two-core wire, and a connecting portion connecting the rear end side of the first core wire and the front end side of the second core wire,
Torsional rigidity ratio of the second core wire large diameter portion of the second core wire to the large core rear end diameter portion of the first core wire (torsional rigidity of the second core wire large diameter portion of the second core wire / the first core wire The torsional rigidity of the rear end diameter of the core wire is more than 1 and 5 or less, and the medical guide wire and the image used for the diagnostic imaging catheter according to any one of claims 1 to 2 Assembly with diagnostic catheter . 4. The diagnostic imaging catheter according to claim 3, wherein the connection portion is connected by brazing or welding joint between a rear end of the first core wire and a front end of the second core wire. 5. An assembly of a medical guide wire and a diagnostic imaging catheter . The first core wire includes a rear end connection diameter small convex portion at the rear end, and the second core wire includes a front end connection diameter small convex portion at the front end,
The connection of the connecting portion is inserted into the inside of the tubular member having pseudo-elastic characteristics by inserting a small convex portion of the rear end connection diameter of the first core wire from one side, and the front end connection diameter of the second core wire from the other side. Insert a small convex part,
4. The connection according to claim 3, wherein the tubular member, the rear end connection diameter small convex portion, and the front end connection diameter small convex portion are connected by any one or both of adhesive bonding and welding bonding. An assembly of a medical guide wire and a diagnostic imaging catheter used for a diagnostic imaging catheter . An assembly of a medical guide wire and a diagnostic imaging catheter used in the diagnostic imaging catheter according to any one of claims 1 to 5 ;
An optical coherence tomography diagnostic apparatus having a scanner and a pullback unit that rotate the optical probe while rotating and an operation control device that processes measurement data from the optical probe and displays an image is provided. An assembly of a medical guide wire used for a diagnostic imaging catheter, a diagnostic imaging catheter, and an optical coherence tomography diagnostic apparatus.

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