JP2021036923A - Guide wire - Google Patents

Abstract

To provide a guide wire capable of reducing a frictional resistance between a guide wire surface and a biological lumen part by a simple structure.SOLUTION: A guide wire 1 includes a long wire body 10, an outer layer part 4 arranged on the outer periphery of a tip part of the wire body 10, for covering the tip part, and a rotor 71 having a part projecting toward the outside of the outer layer part 4, and rotating when receiving external force by having a contact with a biological lumen part.SELECTED DRAWING: Figure 1

Description

The present invention relates to a guide wire, particularly a guide wire used when introducing a catheter into a living lumen such as a blood vessel or a bile duct.

Conventionally, a procedure called PCI (Percutaneous Coronary Intervention) has been performed for the treatment of blood vessels in which stenosis or occlusion has developed. In general PCI, a medical device such as a balloon catheter or a stent is delivered to a lesion such as a stenosis to be treated, the stenosis is expanded by a balloon, and a stent is placed in the stenosis. Guide wires are used to deliver medical devices such as balloon catheters and stents around the lesion.

In addition, the above-mentioned procedures using balloon catheters and stents are also performed for the treatment of peripheral blood vessels such as femoral, iriac, linal, and shunt. Again, the guidewire is used to deliver the medical device around the lesion.

When guiding a medical device to a lesion such as a stenosis or occlusion, the guidewire travels through the bent blood vessel. Further, in a lesion such as a stenosis or an obstruction, the guide wire inserts (penetrates) the lesion. At this time, the operator operates the tip end portion of the guide wire by applying a pushing force or rotation to the base end portion of the guide wire.

Patent Document 1 discloses a rotor microrobot arranged at one end of a catheter by a ball socket joint method. The rotor microrobot disclosed in Patent Document 1 rotates a connected rotating member in response to steering by a magnetic field, so that when an obstructed lesion is opened, an accurate site is opened through the steering of the rotating member. Is possible.

Japanese Unexamined Patent Publication No. 2016-150257

As described above, the guide wire travels in the bent blood vessel and inserts (penetrates) the lesion. At this time, the tip of the guide wire may be pressed against the wall surface in the living lumen. When the tip of the guide wire is pressed against the wall surface in the biological lumen, the frictional resistance between the guide wire and the wall surface in the biological lumen increases, and the operability of the guide wire may decrease.

Further, when the frictional resistance at the tip of the guide wire increases, the tip of the guide wire is likely to be caught in a narrowed portion including a calcified lesion in the living lumen, which may reduce the operability of the guide wire. When the stent is placed in the living lumen, the guide wire may get caught in the stent strut at the tip or enter the gap between the wall surface in the living lumen and the stent strut. There is a risk that the operability of the Further, if the guide wire is pushed in while the tip of the guide wire is caught, the tip of the guide wire may be bent. The movement of the tip of the guide wire that occurs when this bending is eliminated may damage the wall surface in the lumen of the living body.

The rotating member of the rotor microrobot disclosed in Patent Document 1 has the shape of a spiral drill or propeller, and rotates in response to steering by a magnetic field. Therefore, the guide wire or catheter to which the rotor microrobot disclosed in Patent Document 1 is applied has a problem that the structure becomes complicated and the operation becomes complicated.

The present invention has been made to solve the above problems, and an object of the present invention is to provide a guide wire capable of reducing frictional resistance between the surface of the guide wire and a portion in the living lumen by a simple structure. And.

The problem is a long wire body, an outer layer portion arranged on the outer periphery of the tip end portion of the wire body portion and covering the tip portion, and a portion inside the biological lumen that partially protrudes toward the outside of the outer layer portion. It is solved by the guide wire of the present invention, which comprises a rotating body that rotates when it comes into contact with an external force.

According to the above configuration, a part of the rotating body protrudes toward the outside of the outer layer portion that covers the tip end portion of the wire body. Then, the rotating body rotates when it comes into contact with a portion in the lumen of the living body (for example, a wall surface or a narrowed portion) and receives an external force. As a result, in the guide wire of the present invention, the frictional resistance between the surface of the outer layer portion and the portion of the biological lumen is reduced, and the deterioration of the operability of the guide wire is suppressed. Further, the rotating body of the guide wire of the present invention rotates by receiving an external force in contact with a portion inside the living lumen even if magnetic or electrical power is not supplied. Thereby, the guide wire of the present invention can reduce the frictional resistance between the surface of the outer layer portion and the portion of the biological lumen portion by a simple structure.

Further, the guide wire of the present invention reduces the frictional resistance at the tip of the guide wire. As a result, the tip of the guide wire is less likely to be caught in the narrowed portion including the calcified lesion, and the deterioration of the operability of the guide wire and the occurrence of bending are suppressed. Further, even when the stent is placed in the lumen of the living body, the tip of the guide wire is less likely to be caught by the strut of the stent, and the operability of the guide wire is suppressed and the occurrence of bending is suppressed.

Preferably, the rotating body includes at least one of a tip rotating body provided at the tip of the outer layer portion and a lateral rotating body provided on the side of the outer layer portion.

According to the above configuration, the rotating body includes at least one of a tip rotating body and a lateral rotating body. The tip of the guide wire is likely to first come into contact with a portion of the living lumen as the guide wire travels through the living lumen. Further, since the tip of the guide wire is a portion to which the load is most applied when the guide wire is operated, the frictional resistance tends to increase. Therefore, when a rotating body is provided at the tip of the guide wire (the tip of the outer layer portion) (when the rotating body includes the tip rotating body), between the surface of the tip of the outer layer portion and the portion of the biological lumen. Friction resistance is reduced, and deterioration of guide wire operability is further suppressed. In particular, by reducing the frictional resistance at the tip of the outer layer portion, the guide wire can effectively prevent the tip portion from entering the gap between the wall surface in the living lumen and the stent. Further, the lateral portion of the outer layer portion is likely to come into contact with the blood vessel wall when the operator deforms (reshapes) the tip portion of the guide wire into a curved shape in order to improve the blood vessel selectivity. Therefore, when the rotating body is provided on the side of the outer layer portion (when the rotating body includes the lateral rotating body), when the operator deforms the tip portion of the guide wire into a curved shape, the outer layer portion The frictional resistance between the lateral surface and the portion of the biological lumen is reduced, and the decrease in the operability of the guide wire is further suppressed.

Preferably, the wire body has a flat plate portion provided on the tip side of the wire body, and the tip rotating body is formed when an ellipse is rotated about a major axis or a minor axis. It is a spheroid, and the long axis of the spheroid is parallel to the main surface of the flat plate portion.

According to the above configuration, since the tip rotating body is a rotating ellipsoid, the tip rotating body has anisotropy in the rotation direction. Therefore, the guide wire can reduce the frictional resistance between the tip of the guide wire and the wall surface in the living lumen, and can control the moving direction of the tip of the guide wire in any direction. This improves the vascular selectivity of the guide wire. Further, according to the above configuration, when the operator reshapes the tip portion of the guide wire, the reshape direction and the long axis of the tip rotating body can be orthogonal to each other. This makes the guide wire more vascular selectivity. In the specification of the present application, the direction in which the tip of the guide wire is curved by the reshape is referred to as the "reshape direction".

Further, according to the above configuration, since the wire body has the flat plate portion, when the operator reshapes the tip portion of the guide wire, the operator bends the tip portion of the guide wire with the main surface of the flat plate portion as the inner surface or the outer surface. be able to. Further, since the long axis of the tip rotating body (rotating ellipsoid) is parallel to the main surface of the flat plate portion, the operator can reshape the tip portion of the guide wire in the reshaping direction and the length of the tip rotating body. The axes can be orthogonal to each other. This makes the guide wire more vascular selectivity.

Preferably, the guide wire of the present invention is further provided with a support portion fixed to at least one of the wire body and the outer layer portion to support the tip rotating body.

According to the above configuration, since the tip rotating body is supported by the support portion, the tip rotating body is stably arranged and the tip rotating body is suppressed from falling off. Further, the tip rotating body is supported by the support portion and easily rotates. Further, the support portion that supports the tip rotating body is fixed to at least one of the wire body and the outer layer portion. Therefore, the guide wire is ensured to have torque transmissibility.

Preferably, the support portion is connected to a pedestal bottom surface portion that receives the tip rotating body and an edge portion of the pedestal bottom surface portion, covers the periphery of the tip rotating body portion, and together with the pedestal bottom surface portion, at least the tip rotating body portion. It is characterized by having a tapered pedestal side surface portion that accommodates a part of the pedestal and whose outer shape shrinks toward the tip end side, and an opening that projects the part of the tip rotating body.

According to the above configuration, since the support portion accommodates at least a part of the tip rotating body in the space between the pedestal bottom surface portion and the pedestal side surface portion, the tip rotating body is stably arranged and the tip rotating body is arranged. Dropout is suppressed. Further, since the side surface portion of the pedestal has a tapered shape whose outer shape shrinks toward the tip end side, the tip portion of the guide wire can be easily inserted into the narrow living lumen.

Preferably, the support portion is further characterized by having a joint portion extending from the bottom surface portion of the pedestal and fixed to the outer layer portion.

According to the above configuration, the joint portion extending from the bottom surface portion of the pedestal of the support portion is fixed to the outer layer portion, so that the support portion can stably support the tip rotating body. Further, since the joint portion is fixed to the outer layer portion, the torque transmissibility of the guide wire is ensured.

Preferably, the support portion further includes a pedestal ring portion that is fixed to the pedestal side surface portion and receives the outer peripheral portion of the tip rotating body.

According to the above configuration, since the pedestal ring portion receives the tip rotating body on the tip side of the pedestal bottom surface portion, the tip rotating body can be stably supported. Further, the axial length of the pedestal side surface portion (the axial length from the pedestal bottom surface portion to the opening) can be increased as compared with the case where the pedestal ring portion is not provided. As a result, the tapered shape of the side surface of the pedestal can be lengthened, so that the guide wire can be inserted into a narrow living lumen and penetrate into a lesion such as a stenosis or an obstruction. Further, according to the above configuration, the space for accommodating the tip rotating body (the space between the pedestal bottom surface portion and the pedestal side surface portion) becomes wider. As a result, the accommodation space of the tip rotating body can hold a larger amount of the drug or the lubricant.

Preferably, the outer layer portion is a coil formed by spirally winding a wire, and the support portion is a cylindrical shape having an opening fixed to the coil and receiving an outer peripheral portion of the tip rotating body. It is characterized by being a member.

According to the above configuration, the support portion can have a simple structure in which the cylindrical member is fixed to the coil which is the outer layer portion.

Preferably, the outer layer portion is a first coil formed by spirally winding a wire, and the support portion is formed by spirally winding a wire and at least one of the wire bodies. It is a second coil that covers the portion, and the second coil is characterized in that it receives the tip rotating body at the tip portion.

According to the above configuration, since the support portion of the coil is flexible and elastic, the tip rotating body moves in the axial direction of the guide wire according to the pushing amount of the tip rotating body supported by the tip of the second coil. It becomes movable. Therefore, the tip of the guide wire is excellent in flexibility.

Preferably, the outer layer portion is a covering portion that covers the tip end portion of the wire body, and the rotating body is rotatably fitted into a hole portion formed in the covering portion.

According to the above configuration, the rotating body is rotatably fitted in the hole of the covering portion, and a part of the rotating body protrudes outward from the surface of the covering portion. Then, the rotating body rotates when it comes into contact with a portion in the lumen of the living body (for example, a wall surface or a narrowed portion) and receives an external force. As a result, in the guide wire of the present invention, the frictional resistance between the surface of the covering portion and the portion of the biological lumen is reduced, and the deterioration of the operability of the guide wire is suppressed. Further, the rotating body of the guide wire of the present invention rotates by receiving an external force in contact with a portion inside the living lumen even if magnetic or electrical power is not supplied. Thereby, the guide wire of the present invention can reduce the frictional resistance between the surface of the covering portion and the portion of the biological lumen by a simple structure.

Preferably, the outer layer portion is a tubular member having an internal space through which the tip end portion of the wire body is inserted and having a slit connecting the internal space and the external space, and the said outer layer portion is adjacent to each other through the slit. The tubular members are connected to each other by a link portion, and the lateral rotating body can rotate in a state of being sandwiched between the tubular member and a support film fixed inside the tubular member. A part of the lateral rotating body provided is characterized in that it protrudes to the outside of the tubular member through the slit.

According to the above configuration, the tubular member can have flexibility and blood vessel followability is ensured. Further, a part of the lateral rotating body protrudes outward from the surface of the tubular member. The lateral rotating body is rotatably provided while being sandwiched between the tubular member and the support membrane fixed inside the tubular member, and is provided in a portion inside the living lumen (for example, a wall surface or a wall surface). It rotates when it comes into contact with a constriction (such as a constriction) and receives an external force. As a result, in the guide wire of the present invention, the frictional resistance between the lateral surface of the tubular member and the portion of the biological lumen is reduced, and the deterioration of the operability of the guide wire is suppressed. Further, the lateral rotating body rotates by receiving an external force in contact with the wall surface in the living lumen even if magnetic or electrical power is not supplied. Thereby, the guide wire of the present invention can reduce the frictional resistance between the lateral surface of the tubular member and the wall surface in the living lumen by a simple structure. Further, when the tip rotating body is provided at the tip of the tubular member (when the rotating body includes the tip rotating body), the frictional resistance between the surface of the tip of the tubular member and the portion of the biological lumen is increased. It is reduced, and the deterioration of the operability of the guide wire is further suppressed.

Further, the guide wire of the present invention reduces the frictional resistance at the tip of the guide wire. As a result, the tip of the guide wire is less likely to be caught in the narrowed portion or the stent in the living lumen, and the guide wire is suppressed from being lowered in operability and bending of the guide wire.

Preferably, the tubular member has an arc portion provided at a position of the lateral rotating body inside the slit, and the width of the slit and the inner diameter of the arc portion are the diameters of the lateral rotating body. It is characterized by being smaller than.

According to the above configuration, the lateral rotating body is prevented from falling off to the outside of the tubular member through the slit. Further, the lateral rotating body is arranged at the position of the arc portion and is held by the arc portion, and the arc portion suppresses the movement of the lateral rotating body in the axial direction of the wire body or the circumferential direction of the tubular member.

According to the present invention, it is possible to provide a guide wire capable of reducing the frictional resistance between the surface of the guide wire and the portion in the living lumen by a simple structure.

It is sectional drawing which shows the guide wire which concerns on 1st Embodiment of this invention. It is sectional drawing which shows the tip part of the guide wire of this embodiment. It is sectional drawing which shows the state which the guide wire of this embodiment is in contact with a constriction part. It is sectional drawing which shows the state which the guide wire of this embodiment is in contact with a stent. It is a perspective view which shows the tip | tip unit of this embodiment. It is a perspective view which shows the support part of this embodiment. It is a perspective view explaining the modification of the method of fixing the support part of this embodiment. It is a perspective view which shows the 1st manufacturing method of the tip unit of this embodiment. It is a perspective view which shows the 2nd manufacturing method of the tip unit of this embodiment. It is a perspective view which shows the 1st modification of the tip unit of this embodiment. It is a figure which shows the 2nd modification of the tip unit of this embodiment. It is a figure which shows the 3rd modification of the tip unit of this embodiment. It is a figure which shows the 4th modification of the tip unit of this embodiment. It is a figure which shows the 5th modification of the tip unit of this embodiment. It is sectional drawing which shows the guide wire which concerns on the modification of this embodiment. It is a perspective view which shows the tip | tip unit of this modification. It is a top view which shows the tip | tip unit of this modification. It is sectional drawing which shows the 1st modification of the support part of this embodiment. It is sectional drawing which shows the 2nd modification of the support part of this embodiment. It is sectional drawing which shows the 3rd modification of the support part of this embodiment. It is sectional drawing which shows the guide wire which concerns on 2nd Embodiment of this invention. It is an example of the cross-sectional view of the cut surface C3-C3 shown in FIG. It is sectional drawing which shows the guide wire which concerns on 3rd Embodiment of this invention. It is an enlarged view of the area A11 shown in FIG. 23. It is a top view when viewed from the direction of the arrow A9 shown in FIG. It is sectional drawing of the cut surface C4-C4 shown in FIG. 24.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings.
Since the embodiments described below are suitable specific examples of the present invention, various technically preferable limitations are added, but the scope of the present invention particularly limits the present invention in the following description. Unless otherwise stated, the present invention is not limited to these aspects. Further, in each drawing, the same components are designated by the same reference numerals, and detailed description thereof will be omitted as appropriate.

FIG. 1 is a cross-sectional view showing a guide wire according to the first embodiment of the present invention.
In the present specification, the side to be inserted into the cavity of the guide wire is referred to as "tip" or "tip side", and the operating side is referred to as "base end" or "base end side". Specifically, in FIGS. 1 to 4, 7, 7, 15, 18 to 21, and 23 to 25, the left side is the "tip" or "tip side", and the right side is the "base end" or "base". It is called "end side". Further, in the present specification, the tip portion means a portion including a certain range in the axial direction from the tip (leading edge), and the proximal end portion is a fixed range in the axial direction from the proximal end (most proximal end). It shall mean the part including. Further, in FIGS. 1, 15 and 23, in order to facilitate understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated and schematically shown. That is, the ratio between the length direction and the thickness direction is different from the actual one.

The guide wire 1 is a guide wire used by inserting it into the lumen of a catheter (including an endoscope). The guide wire 1 shown in FIG. 1 includes a wire main body 10, a coil (outer layer portion) 4 installed at the tip of the wire main body 10, and a tip unit 7 provided at the tip of the coil 4. The "coil" of the present embodiment is an example of the "outer layer portion" of the present invention.

The wire body 10 is a long wire having flexibility, and has a first wire 2 arranged on the distal end side and a second wire 3 arranged on the proximal end side of the first wire 2. The first wire 2 and the second wire 3 are preferably joined (connected) to each other at the joint portion (joint surface) 6 by welding. The welding method between the first wire 2 and the second wire 3 is not particularly limited, and examples thereof include friction welding, spot welding using a laser, and butt resistance welding such as butt seam welding and upset welding. Among these, butt resistance welding is preferable because it is relatively easy and high joint strength can be obtained. The total length of the guide wire 1 is not particularly limited, but is preferably about 200 to 5000 mm.

In the present embodiment, the first wire 2 includes a first diameter constant portion 21, a first taper portion 22, a second diameter constant portion 23, a second taper portion 24, and a third diameter constant portion 25. Have. The outer diameter of the first diameter constant portion 21 is substantially constant. The second diameter constant portion 23 is located closer to the tip side than the first diameter constant portion 21. The outer diameter of the second diameter constant portion 23 is smaller than the outer diameter of the first diameter constant portion 21, and is substantially constant. The first taper portion 22 is located between the first diameter constant portion 21 and the second diameter constant portion 23, and is connected to the first diameter constant portion 21 and the second diameter constant portion 23. The outer diameter of the first tapered portion 22 gradually decreases toward the tip end. The third diameter constant portion 25 is located closer to the proximal end side than the first diameter constant portion 21. The outer diameter of the third diameter constant portion 25 is larger than the outer diameter of the first diameter constant portion 21 and is substantially constant. The second taper portion 24 is located between the first diameter constant portion 21 and the third diameter constant portion 25, and is connected to the first diameter constant portion 21 and the third diameter constant portion 25. The outer diameter of the second tapered portion 24 gradually decreases toward the tip end. The third diameter constant portion 25, the second taper portion 24, the first diameter constant portion 21, the first taper portion 22, and the second diameter constant portion 23 are formed from the base end side to the tip end side of the first wire 2. They are arranged in order. The shape of the first wire 2 is not limited to this. For example, a flat plate portion formed in a flat plate shape may be provided at the tip end portion of the third diameter constant portion 23. The details of the flat plate portion will be described later.

In the first wire 2, a second diameter constant portion 23 and a first diameter constant portion 21 are formed via the first taper portion 22, and the first diameter constant portion 21 and the third diameter are formed via the second taper portion 24. A fixed portion 25 is formed. As a result, the rigidity (flexural rigidity, torsional rigidity) of the first wire 2 gradually decreases toward the tip of the guide wire 1. As a result, the guide wire 1 can obtain good flexibility at the tip portion, improve the followability to blood vessels and the like, and improve safety, and can prevent bending and the like.

The taper angles (decrease rate of outer diameter) of the first tapered portion 22 and the second tapered portion 24 may be constant along the longitudinal direction of the wire main body 10 or may change along the longitudinal direction. The first tapered portion 22 and the second tapered portion 24 may be formed by alternately repeating a portion having a large taper angle and a portion having a small taper angle a plurality of times.

The average outer diameter of the first wire 2 is smaller than the average outer diameter of the second wire 3. As a result, the guide wire 1 has a property of being highly flexible on the first wire 2 arranged on the distal end side, and has a property of being highly rigid on the second wire 3 arranged on the proximal end side. Therefore, the guide wire 1 can achieve both the flexibility of the tip portion and excellent operability (pushing property, torque transmission property, etc.). The length of the first wire 2 is not particularly limited, but is preferably about 20 to 1000 mm.

The outer diameter of the second wire 3 is substantially constant along the longitudinal direction. The outer diameter of the second wire 3 is substantially equal to the outer diameter of the third diameter constant portion 25 of the first wire 2. As a result, when the base end of the third diameter constant portion 25 of the first wire 2 and the tip end of the second wire 3 are joined, the difference in outer diameter between the first wire 2 and the second wire 3 The step due to the above is hardly generated on the outer periphery of the joint portion 6. As a result, a continuous surface is formed at the joint portion 6 between the first wire 2 and the second wire 3.

Further, the second wire 3 has an outer diameter larger than the outer diameter of the first diameter constant portion 21 of the first wire 2. The outer diameter of the second wire 3 is, for example, about 1.02 to 5 times the outer diameter of the first diameter constant portion 21 of the first wire 2. The length of the second wire 3 is not particularly limited, but is preferably about 20 to 4800 mm, more preferably about 1400 to 3000 mm.

The constituent materials of the first wire 2 and the second wire 3 are not particularly limited, and are, for example, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS424, respectively. , SUS430F, SUS302 and all other SUS varieties), piano wire, cobalt-based alloys, alloys exhibiting pseudoelasticity (including superelastic alloys), and various other metal materials. The pseudoelastic alloy includes any shape of the stress-strain curve due to tension, and includes those in which the transformation points such as As, Af, Ms, and Mf can be remarkably measured and those in which the transformation points cannot be measured. Further, the pseudoelastic alloy includes all alloys that are greatly deformed (strained) by stress and almost return to their original shape by removing stress. Among them, the constituent material of the first wire 2 is preferably a Ni—Ti alloy, and the constituent material of the second wire 3 is preferably stainless steel.

In the present embodiment, the first wire 2 and the second wire 3 are made of different materials. However, the first wire 2 and the second wire 3 may be made of the same or the same kind of metal material. Here, "the same kind" means that the main metal materials in the alloy are the same.

In the above description, the mode in which the first wire 2 and the second wire 3 are joined is described as an example, but the wire main body 10 may be a wire of one member having no joint. Examples of the constituent material of the wire in that case include the same materials as described above. The constituent material of the wire is preferably stainless steel, a cobalt-based alloy, or a pseudoelastic alloy.

A coil 4 is arranged on the outer periphery of the tip of the wire body 10 so as to cover the tip of the wire body 10. By installing the coil 4, the wire body 10 has a smaller contact area on the surface of the wire body 10 with respect to the inner wall of the catheter and the portion inside the living lumen. As a result, the guide wire 1 reduces the frictional resistance between the inner wall of the catheter or the inner wall of the living lumen and the surface of the wire body 10, and improves the operability of the guide wire 1.

The coil 4 is a member in which a wire (thin wire) 41 is spirally wound, and is installed so as to cover at least a portion on the tip end side of the first wire 2. In the guide wire 1 shown in FIG. 1, the tip end side portion of the first wire 2 is inserted through the substantially central portion inside the coil 4 (the portion of the shaft 11 of the wire body 10). Further, the portion on the tip end side of the first wire 2 is inserted in non-contact with the inner peripheral surface of the coil 4. That is, the coil 4 covers at least the tip end side of the first wire 2 in a state of being separated from the first wire 2 (in a state of non-contact with the first wire 2).

The outer diameter of the coil 4 is substantially constant along the axis 11 direction (longitudinal direction), preferably about 0.25 to 0.89 mm, and more preferably about 0.25 to 0.46 mm. .. In the specification of the present application, the "outer diameter of the coil" does not mean the outer diameter (wire diameter) of the wire of the coil, but the outer diameter of the entire coil in which the wire is spirally wound. The outer diameter of the coil 4 is preferably substantially equal to the diameter of the second wire 3.

The total length (length along the axis 11 direction) of the coil 4 is not particularly limited, but is preferably about 5 to 500 mm, and more preferably about 30 to 300 mm. The diameter (wire diameter) of the wire 41 is preferably about 0.023 to 0.087 mm, more preferably about 0.040 to 0.070 mm.

In the case of this embodiment, the shape of the cross section of the wire 41 is a circle. However, the shape of the cross section of the wire 41 is not limited to the circle. The shape of the cross section of the strand 41 may be, for example, an ellipse or a quadrangle. In the present specification, the "cross section of the wire" refers to a cut end (cut surface) when the wire is cut in a plane perpendicular to the axis extending in the longitudinal direction of the wire.

Further, in the coil 4 of the guide wire 1 shown in FIG. 1, the spirally wound strands 41 are densely arranged without any gap in a state where no external force is applied. However, the arrangement form of the strands 41 is not limited to this. A gap may be formed between the strands 41 in a state where no external force is applied.

The constituent material of the coil 4 (wire 41) may be either a metal material or a resin material, and is more preferably a metal material. As the metal material used for the coil 4, stainless steel, superelastic alloys, cobalt-based alloys, metals such as gold, platinum, and tungsten, or alloys containing these can be used. The coil 4 may have a tip end portion and a base end portion made of different materials. The tip of the coil 4 can be made of a material having X-ray opacity, and the base end of the coil 4 can be made of a material or the like that is more permeable to X-rays than the tip. Is. When the coil 4 is made of an X-ray opaque material such as a precious metal, X-ray contrast can be obtained at the tip of the guide wire 1. As a result, the operator can insert the guide wire 1 into the living body while confirming the position of the tip portion under fluoroscopy.

As shown in FIG. 1, the coil 4 is fixed to the wire body 10 at two points. The tip of the coil 4 is fixed to the tip of the first wire 2 via the tip unit 7. That is, the tip unit 7 is fixed to the coil 4 and the first wire 2 by solder (wax material), an adhesive, or the like. The base end portion of the coil 4 is fixed in the middle of the first wire 2 (near the boundary between the first diameter constant portion 21 and the second tapered portion 24) by the fixing material 53. By fixing the coil 4 to the wire body 10 at such a location, the coil 4 can be reliably connected to the wire body 10 without impairing the flexibility of the tip portion (the portion where the coil 4 exists) of the guide wire 1. It is fixed. The fixing location and the fixed number of the coil 4 with respect to the wire main body 10 are not limited to this.

Each of the fixing materials 53 is composed of solder (wax material). The fixing material 53 is not limited to solder, and may be, for example, an adhesive. Further, the method of fixing the coil 4 to the wire body 10 and the tip unit 7 is not limited to the method using a fixing material, and may be, for example, welding.

As shown in FIG. 1, the wire main body 10 has resin coating layers 8 and 9 as a coating layer covering all or a part of the outer peripheral surface (outer surface). The resin coating layer 8 is provided at least in a region from the tip of the guide wire 1 to the vicinity of the base end of the second tapered portion 24. In the guide wire 1 shown in FIG. 1, the resin coating layer 8 is provided on the outer periphery of the coil 4. Further, the resin coating layer 9 is provided on a part of the first wire 2 and on the outer periphery of the second wire 3.

The resin coating layer 8 is preferably made of a hydrophilic material. Since the hydrophilic material becomes wet and provides lubricity, the frictional resistance of the guide wire 1 is reduced and the operability of the guide wire 1 is improved. Examples of the hydrophilic material include a cellulose-based polymer substance, a polyethylene oxide-based polymer substance, and a maleic anhydride-based polymer substance (for example, a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer). , Acrylamide-based polymer substances (for example, polyacrylamide, block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

The resin coating layer 9 is preferably made of a material that can reduce friction. Examples of materials capable of reducing such friction include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, and fluororesin (fluorine-based resin). PTFE, ETFE, etc.), or composite materials thereof.

The thickness of the resin coating layers 8 and 9 is not particularly limited, and both are preferably about 1 to 100 μm, and more preferably about 1 to 30 μm.

In the present embodiment, the outer peripheral surfaces of the coil 4 and the wire body 10 are subjected to treatments (roughening, chemical treatment, heat treatment, etc.) for improving the adhesion of the resin coating layers 8 and 9. An intermediate layer that can improve the adhesion of the resin coating layers 8 and 9 may be provided.

The tip unit 7 is provided at the tip of the coil 4 and is fixed to the coil 4 and the first wire 2 by solder (wax material), an adhesive or the like. The tip unit 7 has a tip rotating body 71 and a support portion 72. The tip rotating body 71 is provided at the tip of the coil 4. The guide wire 1 shown in FIG. 1 is an example in which the "rotating body" of the present invention includes the "tip rotating body". The "rotating body" may include a "side rotating body" provided on the side of the outer layer portion. An example in which the "rotating body" includes the "side rotating body" will be described later with reference to FIGS. 21 to 26. A part of the tip rotating body 71 protrudes or is exposed outward from the surface of the coil 4 or the support portion 72. The other part of the tip rotating body 71 is housed inside the support portion 72. The tip rotating body 71 is provided as a sphere or a rotating ellipsoid, and can rotate while being housed inside the support portion 72. As used herein, the term "spheroid" refers to a solid formed by rotating an ellipse around the major axis of the ellipse or the minor axis of the ellipse. The tip rotating body 71 rotates when it comes into contact with a portion in the living lumen such as the inner wall of a blood vessel or a narrowed portion and receives an external force. The operation of the tip rotating body 71 will be further described with reference to the drawings.

FIG. 2 is a cross-sectional view showing the tip end portion of the guide wire of the present embodiment.
FIG. 3 is a cross-sectional view showing a state in which the guide wire of the present embodiment is in contact with the narrowed portion.
FIG. 4 is a cross-sectional view showing a state in which the guide wire of the present embodiment is in contact with the stent.
Note that FIG. 2A is a cross-sectional view showing a state before the tip of the guide wire of the present embodiment is inserted into the living lumen. FIG. 2B is a cross-sectional view showing a state in which the tip end portion of the guide wire of the present embodiment is inserted into the living lumen and is in contact with the wall surface in the living lumen. Further, in FIGS. 2 and 3, for convenience of explanation, the tip unit 7 is represented as a perspective view.

In general, the guide wire travels through a bent blood vessel and inserts (penetrates) a lesion. At this time, the tip of the guide wire may be pressed against the wall surface in the living lumen. When the tip of the guide wire is pressed against the wall surface in the biological lumen, the frictional resistance between the guide wire and the wall surface in the biological lumen increases, and the operability of the guide wire may decrease.

Further, when the frictional resistance at the tip of the guide wire increases, the tip of the guide wire is likely to be caught in a narrowed portion including a calcified lesion in the living lumen, which may reduce the operability of the guide wire. When the stent is placed in the living lumen, the guide wire may get caught in the stent strut at the tip or enter the gap between the wall surface in the living lumen and the stent strut. There is a risk that the operability of the Further, if the guide wire is pushed in while the tip of the guide wire is caught, the tip of the guide wire may be bent. The movement of the tip of the guide wire that occurs when this bending is eliminated may damage the wall surface in the lumen of the living body.

On the other hand, the guide wire 1 according to the present embodiment includes a tip unit 7 provided at the tip of the coil 4. As shown in FIG. 2A, the tip of the coil 4 extends in a substantially straight line before being inserted into the living lumen. On the other hand, as shown in FIG. 2B, the tip of the coil 4 may be pressed against the wall surface 55 in the living lumen as it travels through the living lumen.

According to the guide wire 1 according to the present embodiment, a part of the tip rotating body 71 protrudes or is exposed outward from the surface of the coil 4 or the support portion 72. Then, as shown by the arrow A1 shown in FIG. 2B, the tip rotating body 71 rotates when it comes into contact with a portion in the living lumen (for example, a wall surface or a narrowed portion) and receives an external force. As a result, in the guide wire 1 according to the present embodiment, the frictional resistance between the tip portion of the coil 4 and the portion of the biological lumen is reduced, and the deterioration of the operability of the guide wire 1 is suppressed. Further, the tip rotating body 71 rotates by receiving an external force in contact with the wall surface 55 in the living lumen even if magnetic or electrical power is not supplied. Thereby, the guide wire 1 according to the present embodiment can reduce the frictional resistance between the coil 4 or the tip unit 7 and the wall surface 55 in the biological lumen by a simple structure.

Further, the guide wire 1 according to the present embodiment reduces the frictional resistance at the tip of the guide wire 1. As a result, as shown in FIG. 3, the tip of the guide wire 1 is less likely to be caught in the narrowed portion 56 including the calcified lesion 57, and the deterioration of the operability of the guide wire 1 and the occurrence of bending are suppressed. Further, as shown in FIG. 4, even when the stent is placed in the lumen of the living body, the tip of the guide wire 1 is less likely to be caught by the strut 58 of the stent, and the operability of the guide wire 1 is improved. The occurrence of reduction and bending is suppressed.

As shown in FIGS. 1 to 2 (b), the tip unit 7 is preferably provided in a portion (region) including at least the tip of the guide wire 1. It is more preferable that the tip rotating body 71 is provided at least at the tip of the guide wire 1. As shown in FIG. 2 (b), the tip of the guide wire 1 first reaches a portion in the biological lumen (wall surface 55 in FIG. 2 (b)) when the guide wire 1 advances in the biological lumen. Is likely to come into contact with. Further, since the tip of the guide wire 1 is a portion to which the load is most applied when the guide wire is operated, the frictional resistance tends to increase. Therefore, by providing the rotating body at the tip of the guide wire 1 (the rotating body includes the tip rotating body 71), the frictional resistance between the surface of the tip of the guide wire 1 and the portion of the biological lumen is reduced. , The deterioration of the operability of the guide wire 1 is further suppressed. In particular, by reducing the frictional resistance at the tip of the guide wire 1, the guide wire 1 can effectively prevent the tip from entering the gap between the wall surface 55 and the stent in the living lumen.

Next, the tip unit of the present embodiment will be further described with reference to the drawings.
FIG. 5 is a perspective view showing the tip unit of the present embodiment.
FIG. 6 is a perspective view showing a support portion of the present embodiment.
FIG. 7 is a perspective view illustrating a modified example of the method of fixing the support portion of the present embodiment.
FIG. 8 is a perspective view showing a first manufacturing method of the tip unit of the present embodiment.
FIG. 9 is a perspective view showing a second manufacturing method of the tip unit of the present embodiment.

As shown in FIG. 5, the tip unit 7 of the present embodiment has a tip rotating body 71 and a support portion 72. The tip rotating body 71 is a sphere or a rotating ellipsoid. Hereinafter, in the description of FIGS. 5 to 14 (b) and FIGS. 18 to 26, a case where the tip rotating body is a sphere will be taken as an example. Further, in the description of FIGS. 15 to 17 (c), a case where the tip rotating body is a rotating ellipsoid will be given as an example.

The constituent material of the tip rotating body 71 may be either a metal material or a resin material, and is more preferably a metal material. Examples of the metal material used for the tip rotating body 71 include the same materials as those mentioned in the constituent materials of the first wire 2 and the second wire 3. Among these, it is more preferable that Ni—Ti alloy or stainless steel is used as a constituent material of the tip rotating body 71. Alternatively, the constituent material of the tip rotating body 71 may be a fluororesin (PTFE, ETFE, etc.) or the like. In this case, the frictional resistance between the tip of the guide wire 1 and the wall surface 55 in the living lumen is further reduced.

The surface of the tip rotating body 71 may be coated with a coating capable of reducing frictional resistance. Examples of the coating material include a fluororesin and a hydrophilic material that provides lubricity when wet. Further, the tip rotating body 71 may reduce the frictional resistance between the surface of the tip rotating body 71 and the wall surface 55 in the living lumen by providing a fine uneven shape on the surface.

The size (diameter) of the tip rotating body 71 is not particularly limited, but is about 0.1 mm to 0.8 mm.

The support portion 72 has a pedestal bottom surface portion 721, a pedestal side surface portion 722, an opening portion 724, and a joint portion 726.

The pedestal bottom surface portion 721 receives the tip rotating body 71 on the surface (main surface). The shape of the pedestal bottom surface portion 721 is preferably circular, as shown in FIG. The shape of the pedestal bottom surface portion 721 is not limited to a circular shape, and may be a polygon such as a triangle, a quadrangle, or a pentagon.

The pedestal side surface portion 722 corresponds to the side surface (outer surface) of the pillar body having the pedestal bottom surface portion 721 as the bottom surface. The pedestal side surface portion 722 is connected to the edge portion (specifically, the outer peripheral edge portion) of the pedestal bottom surface portion 721, covers the periphery of the tip rotating body 71, and accommodates a part of the tip rotating body 71 together with the pedestal bottom surface portion 721. .. That is, at least a part of the tip rotating body 71 is housed in the space 725 formed between the pedestal side surface portion 722 and the pedestal bottom surface portion 721. The pedestal side surface portion 722 has a tapered shape whose outer shape shrinks toward the tip end side of the support portion 72. That is, the pedestal side surface portion 722 is a part of a cone having the pedestal bottom surface portion 721 as the bottom surface. As shown in FIGS. 5 and 6, when the pedestal bottom surface portion 721 is circular, the pedestal side surface portion 722 is a part of the conical shape. The pedestal side surface portion 722 is not limited to a part of the conical shape, and may be a pillar shape, a barrel shape in which the middle abdomen is curved outward, or a pincushion type in which the middle abdomen is curved inward. Good.

The opening 724 is provided on the tip end side of the support portion 72. In other words, the opening 724 corresponds to the bottom surface of the pillar body having the pedestal bottom surface portion 721 as the bottom surface, which is opposite to the pedestal bottom surface portion 721. As shown in FIGS. 5 and 6, when the pedestal bottom surface portion 721 is circular and the pedestal side surface portion 722 is a part of a conical shape, the opening 724 is circular.

The opening 724 projects a part of the tip rotating body 71 housed in the space 725 outward from the surface of the support portion 72. The protrusion amount L1 of the tip rotating body 71 protruding from the opening 724 is not particularly limited, and is in terms of volume ratio or diameter ratio (when the tip rotating body 71 is a spheroid, the major axis ratio or the minor axis ratio). It is 1% or more and less than 50%, more preferably 20% or more and 30% or less. When the protrusion amount L1 of the tip rotating body 71 is small, the guide wire 1 is suppressed from increasing in length and the outer diameter of the tip portion, and is also suppressed from falling off from the tip rotating body 71. On the other hand, when the protruding amount L1 of the tip rotating body 71 is large, the guide wire 1 has a high probability that the tip rotating body 71 comes into contact with the wall surface 55 in the living lumen. In a state where the tip rotating body 71 is pushed toward the base end side of the guide wire 1, that is, in a state where the tip rotating body 71 and the pedestal bottom surface portion 721 are in contact with each other, the tip rotating body 71, the edge portion of the opening 724, and the edge portion of the opening 724. The gap L2 between them is not particularly limited, but is, for example, 0.002 mm or more on one side and 0.010 mm or less on one side.

The joint portion 726 is a portion fixed to the coil 4 and the first wire 2. The joint portion 726 extends from the pedestal bottom surface portion 721 toward the base end side of the guide wire 1. As shown in FIG. 1, the shape of the joint portion 726 is a cylinder or a cylinder. The outer diameter of the joint portion 726 is equal to or less than the inner diameter of the coil 4, and is inserted into the inside of the coil 4 from the tip end side of the coil 4. The outer peripheral surface of the joint portion 726 is fixed to the inner peripheral surface of the coil 4. When the joint portion 726 has a cylindrical shape, the joint portion 726 is fixed to the tip of the first wire 2 and the bottom surface of the joint portion 726 (the main surface opposite to the pedestal bottom surface portion 721). When the joint portion 726 has a cylindrical shape, the joint portion 726 is fixed at the tip end portion of the first wire 2 and the pedestal bottom surface portion 721. The joint portion 726, the coil 4 and the first wire 2 are fixed by solder (wax material), an adhesive or the like.

As shown in FIGS. 7 (a) and 7 (b), when the shape of the joint portion 726H of the support portion 72H is cylindrical, the inner diameter of the joint portion 726H is equal to or larger than the outer diameter of the coil 4. May be good. The joint portion 726H extends from the bottom surface portion 721 of the pedestal toward the base end side, and is arranged so as to cover the outer peripheral surface on the tip end side of the coil 4 as shown by the arrow A2 shown in FIG. 7A. The inner peripheral surface of the joint portion 726H is fixed to the outer peripheral surface of the coil 4 by solder (wax material), an adhesive, or the like.

The tip unit 7 can be manufactured by pushing the tip rotating body 71 from the opening 724 into the space 725 between the pedestal side surface portion 722 and the pedestal bottom surface portion 721 as shown by the arrow A3 shown in FIG. Alternatively, as shown by the arrow A4 shown in FIG. 9, the tip unit 7 pushes the tip rotating body 71 into the pedestal side surface portion 722 provided as a separate member from the pedestal bottom surface portion 721, and then pedestals the pedestal bottom surface portion 721. It may be manufactured by joining to the edge portion of the side surface portion 722.

According to the present embodiment, since the tip rotating body 71 is supported by the support portion 72, the tip rotating body 71 is stably arranged and the tip rotating body 71 is suppressed from falling off. Further, the tip rotating body 71 is supported by the support portion 72 and easily rotates. Further, the support portion 72 that supports the tip rotating body 71 is fixed to the wire body 10 (specifically, the first wire 2) and the coil 4. Therefore, the guide wire 1 is ensured to have torque transmissibility.

Further, the pedestal side surface portion 722 has a tapered shape whose outer shape shrinks toward the tip end side of the support portion 72. Therefore, the tip of the guide wire 1 can be easily inserted into the narrow living lumen. Further, as shown in FIGS. 5 and 6, when the pedestal bottom surface portion 721 is circular and the pedestal side surface portion 722 is a part of the conical shape, the opening 724 is circular. When the opening 724 is circular, the tip rotating body 71 can be a sphere having a larger diameter. When the tip rotating body 71 is a sphere, the protruding amount L1 of the tip rotating body 71 protruding from the opening 724 can be increased, so that the tip rotating body 71 easily comes into contact with the wall surface 55 in the biological lumen. As a result, the frictional resistance between the guide wire 1 and the wall surface 55 in the living lumen can be reduced more reliably.

Further, since the joint portion 726 extending from the pedestal bottom surface portion 721 is fixed to the coil 4 and the wire main body 10, the support portion 72 can stably support the tip rotating body 71. Further, since the joint portion 726 is fixed to the coil 4 and the wire main body 10, the torque transmissibility of the guide wire 1 is ensured. Further, when the joint portion 726 is fixed to the inner peripheral surface of the coil 4, the outer shape of the support portion 72 may be larger than the outer shape of the coil, or a step may occur between the support portion 72 and the coil 4. Therefore, the deterioration of the operability of the guide wire 1 is suppressed.

The space 725 between the pedestal side surface portion 722 and the pedestal bottom surface portion 721 may be filled with a chemical agent, a lubricant, or the like. In this case, the tip rotating body 71 rotates in contact with a lesion such as a narrowed portion 56 in the living lumen, so that a drug or a lubricant filled in the space 725 can be applied. ..

Next, a modification of the tip unit of the present embodiment will be described with reference to the drawings.
When the components of the tip unit according to the modified example are the same as the components of the tip unit 7 of the present embodiment described above with respect to FIGS. 1 to 9, duplicate description will be omitted as appropriate, and the following will be different. The explanation will focus on the points.

FIG. 10 is a perspective view showing a first modification of the tip unit of the present embodiment.
The tip unit 7A of this modification has a tip rotating body 71 and a support portion 72A. The support portion 72A has a pedestal ring portion 727 provided in a space 725 between the pedestal side surface portion 722 and the pedestal bottom surface portion 721. In this respect, the tip unit 7A of this modification is different from the tip unit 7 described above with respect to FIGS. 1 to 9. The pedestal ring portion 727 is fixed to the inner peripheral surface of the pedestal side surface portion 722. Therefore, the pedestal ring portion 727 receives the outer peripheral portion (outer surface) of the tip rotating body 71 on the tip end side of the pedestal bottom surface portion 721.

According to this modification, since the pedestal ring portion 727 receives the tip rotating body 71 on the tip side of the pedestal bottom surface portion 721, the tip rotating body 71 can be stably supported. Further, the axial length of the pedestal side surface portion 722 (the axial length from the pedestal bottom surface portion 721 to the opening 724) can be increased as compared with the case where the pedestal ring portion 727 is not provided. As a result, the tapered shape of the side surface portion 722 of the pedestal can be lengthened, so that the guide wire can be inserted into a narrow living lumen and penetrated into a lesion such as a stenosis or an obstruction.

Further, according to this modification, since the pedestal ring portion 727 receives the tip rotating body 71 on the tip side of the pedestal bottom surface portion 721, a gap is formed between the tip rotating body 71 and the pedestal bottom surface portion 721. Becomes possible. Therefore, the accommodation space of the tip rotating body 71 (the space 725 between the pedestal bottom surface portion 721 and the pedestal side surface portion 722) can be made wider. As a result, the accommodation space of the tip rotating body 71 can hold a larger amount of the drug or the lubricant.

11 to 14 are views showing the second to fifth modified examples of the tip unit of the present embodiment.
11 (b) is a cross-sectional view of the cut planes C1-C1 shown in FIG. 11 (a). 12 (b) is a cross-sectional view of the cut surface C2-C2 shown in FIG. 12 (a). 13 (b) is a plan view when viewed from the direction of arrow A5 shown in FIG. 13 (a). 14 (b) is a plan view seen from the direction of arrow A6 shown in FIG. 14 (a).

As shown in FIGS. 11A to 12B, the tip rotating body 71 may be provided at a portion other than the tips of the tip units 7B and 7C. In other words, the tip rotating body 71 may be provided on the pedestal side surface portions 722B and 722C. Further, as shown in FIGS. 11A and 11B, the tip rotating body 71 may not be provided at the tip of the tip unit 7B. Even when the rotating body is provided at a portion other than the tip of the tip unit, the tip unit is provided at the tip of the outer layer portion (coil 4 in this embodiment), and the rotating body is located at the tip of the outer layer portion. As far as it goes, the rotating body corresponds to the "tip rotating body".

The tip units 7B and 7C shown in FIGS. 11A to 12B have a plurality of tip rotating bodies 71. The pedestal side surface portions 722B and 722C have a number of openings 724 corresponding to the number of tip rotating bodies 71. The openings 724 of the pedestal side surface portions 722B and 722C are arranged at different positions in the circumferential direction of the guide wire 1, respectively. A part of the tip rotating body 71 projects outward from the surfaces of the support portions 72B and 72C through the opening 724.

According to the tip units 7B and 7C shown in FIGS. 11A to 12B, a plurality of tip rotating bodies 71 project from the pedestal side surface portions 722B and 722C of the support portions 72B and 72C. Therefore, even when the tip of the guide wire 1 is bent in various directions, the tip rotating body 71 can come into contact with the wall surface 55 in the living lumen and rotate. As a result, even when the tip of the guide wire 1 is bent in various directions, the frictional resistance between the tip of the guide wire 1 and the wall surface 55 in the living lumen can be reduced.

The sizes of the plurality of tip rotating bodies 71 may be the same as each other or may be different from each other. When the sizes of the plurality of tip rotating bodies 71 are different, for example, as shown in FIG. 12A, a relatively large tip rotating body 71 is arranged in the central portion of the space 725 and is relatively small. The tip rotating body 71 can be arranged around the relatively large tip rotating body 71.

Further, as in the tip units 7D and 7E shown in FIGS. 13 (a) to 14 (b), a part of the plurality of tip rotating bodies 71 may protrude from one opening. The tip unit 7D shown in FIGS. 13 (a) and 13 (b) has two tip rotating bodies 71 and a support portion 72D. The pedestal bottom surface portion 721 of the support portion 72D has a circular shape. The pedestal side surface portion 722D of the support portion 72D has an elliptical opening 724D provided at the tip thereof. At this time, the pedestal side surface portion 722D is smoothly formed from the circular pedestal bottom surface portion 721 toward the elliptical opening 724D. A part of the two tip rotating bodies 71 projects outward from the surface of the support portion 72D through the elliptical opening 724D.

The tip unit 7E shown in FIGS. 14A and 14B has three tip rotating bodies 71 and a support portion 72E. The pedestal bottom surface portion 721 of the support portion 72E has a circular shape. The pedestal side surface portion 722E of the support portion 72E has an opening 724 provided at the tip. The shape of the opening 724 may be circular or elliptical. A part of the three tip rotating bodies 71 projects outward from the surface of the support portion 72E through the opening 724.

Next, the guide wire according to the modified example of the present embodiment will be described with reference to the drawings.
When the component of the guide wire 1A according to the modified example is the same as the component of the guide wire 1 according to the present embodiment described above with respect to FIGS. 1 to 9, duplicate description will be omitted as appropriate and described below. , The difference will be mainly explained.

FIG. 15 is a cross-sectional view showing a guide wire according to a modified example of the present embodiment.
FIG. 16 is a perspective view showing the tip unit of this modified example.
FIG. 17 is a plan view showing the tip unit of this modified example.
Note that FIG. 17A is a plan view when viewed from a direction orthogonal to the axis 11 of the wire body 10 and the major axis 711 of the tip rotating body 71F. FIG. 17B is a plan view of the tip rotating body 71F when viewed from a direction parallel to the long axis 711. FIG. 17C is a plan view of the wire body 10 when viewed from the tip side along the axis 11.

In the guide wire 1A according to the present modification, the first wire 2A has a first diameter constant portion 21, a second diameter constant portion 23, a first taper portion 22, and a flat plate portion 26. That is, as compared with the first wire 2 described above with respect to FIG. 1, the first wire 2A of the guide wire 1A according to this modification further has a flat plate portion 26. The flat plate portion 26 is provided on the tip end side of the second diameter constant portion 23. The first diameter constant portion 21, the first taper portion 22, the second diameter constant portion 23, and the flat plate portion 26 are arranged in this order from the proximal end side to the distal end side of the first wire 2A. That is, the flat plate portion 26 is arranged on the tip side of the second diameter constant portion 23 and is connected to the second diameter constant portion 23.

The flat plate portion 26 has a flat plate shape (ribbon shape), and may be deformed into a desired shape before use. That is, the operator may bend the tip of the guide wire into a desired shape in advance in order to enhance the vascular selectivity of the guide wire at the bifurcation of the blood vessel. Bending the tip of the guide wire into a desired shape in this way is called reshaping or preforming. In the present specification, the direction in which the tip of the guide wire is curved by the reshape is referred to as the "reshape direction". When the operator reshapes the tip of the guide wire 1A, the operator bends the tip of the guide wire 1A with the main surface of the flat plate portion 26 as the inner surface or the outer surface. Therefore, the reshape direction of the guide wire 1A is a direction perpendicular to the main surface of the flat plate portion 26. That is, the reshape direction is the direction perpendicular to the vertical cross section when the guide wire 1A is cut in the plane including the axis 11 of the wire body 10 (the vertical cross section of the guide wire shown in FIG. In the depth direction).

Further, the guide wire 1A according to this modification includes a tip unit 7F provided at the tip of the coil 4. The tip unit 7F is fixed to the coil 4 and the first wire 2A (specifically, the flat plate portion 26) by solder (wax material), an adhesive, or the like.

As shown in FIG. 16, the tip unit 7F of this modified example has a tip rotating body 71F and a support portion 72F. The guide wire 1A according to the present modification is an example in which the "rotating body" of the present invention includes the "tip rotating body". The tip rotating body 71F is a rotating ellipsoid. The pedestal bottom surface portion 721 of the support portion 72F of this modified example has a circular shape. That is, the length L3 (diameter of the pedestal bottom surface portion 721) shown in FIG. 17 (a) is shown in the length L4 (diameter of the pedestal bottom surface portion 721) shown in FIG. 17 (b) and FIG. 17 (c). It is the same as the length L5 (diameter of the bottom surface portion 721 of the pedestal). The pedestal side surface portion 722F of the support portion 72F is provided at the tip and has an elliptical opening 724F that follows the shape of the tip rotating body 71F. At this time, the pedestal side surface portion 722F is smoothly formed from the circular pedestal bottom surface portion 721 toward the elliptical opening 724F. The support portion 72F has a pedestal ring portion 727F provided in a space 725 between the pedestal side surface portion 722F and the pedestal bottom surface portion 721. The pedestal ring portion 727F is fixed to the inner peripheral surface of the pedestal side surface portion 722F. Therefore, the pedestal ring portion 727F receives the outer peripheral portion (outer surface) of the tip rotating body 71F on the tip end side of the pedestal bottom surface portion 721.

As shown by arrows A7 and A8 shown in FIG. 16, when the tip rotating body 71F comes into contact with the wall surface 55 in the biological lumen and receives an external force, the long axis 711 of the tip rotating body 71F (the long axis of the rotating ellipsoid). Rotates around. That is, the tip rotating body 71F has anisotropy in the rotation direction.

The long axis 711 of the tip rotating body 71F extends in a direction (diameter direction) orthogonal to the axis 11, and the long axis 711 of the tip rotating body 71F is parallel to the main surface of the flat plate portion 26. That is, the long axis 711 of the tip rotating body 71F is included in the plane (vertical cross section of the guide wire shown in FIG. 15) including the axis 11 of the wire body 10 of the guide wire 1A.

According to this modification, since the tip rotating body 71F is a rotating ellipsoid, the tip rotating body 71F has anisotropy in the rotation direction. Therefore, the guide wire 1A can reduce the frictional resistance between the tip of the guide wire 1A and the wall surface 55 in the living lumen, and can control the moving direction of the tip of the guide wire 1A in an arbitrary direction. As a result, the guide wire 1A has improved blood vessel selectivity.

Further, the long axis 711 of the tip rotating body 71F extends in a direction (diameter direction) orthogonal to the axis 11 and is parallel to the main surface of the flat plate portion 26. Therefore, when the tip portion of the guide wire 1A is reshaped, the operator can make the reshape direction and the long axis 711 of the tip rotating body 71F orthogonal to each other. As a result, the guide wire 1A has further improved blood vessel selectivity. The reshape direction and the long axis 711 of the tip rotating body 71F may be arranged in parallel with each other.

According to this modification, the opening 724F provided at the tip of the support 72F has an elliptical shape that follows the shape of the tip rotating body 71F. As a result, the opening 724F can prevent the tip rotating body 71F from falling off and can control the rotation direction of the tip rotating body 71F.

Further, according to the present modification, the support portion 72F has a pedestal ring portion 727F provided in the space 725 between the pedestal side surface portion 722F and the pedestal bottom surface portion 721. Since the pedestal ring portion 727F receives the tip rotating body 71F on the tip side of the pedestal bottom surface portion 721, the tip rotating body 71F can be stably supported. Further, the axial length of the pedestal side surface portion 722F (the axial length from the pedestal bottom surface portion 721 to the opening 724F) can be increased as compared with the case where the pedestal ring portion 727F is not provided. As a result, the tapered shape of the pedestal side surface portion 722F can be lengthened, so that the guide wire 1A has improved insertability into a narrow living lumen and penetration into a lesion such as a stenosis or an obstruction. ..

In the guide wire 1A according to this modification, the support portion 72F does not have to have the pedestal ring portion 727F. In this case, the tip rotating body 71F receives the outer peripheral portion (outer surface) of the tip rotating body 71F at the pedestal bottom surface portion 721.

In the guide wire 1A according to the present modification, the tip rotating body may be a sphere as described above with respect to FIG. When the tip rotating body is a sphere, the tip rotating body 71 (see FIG. 5) can rotate uniformly over the entire circumferential direction (360 ° direction). As a result, the tip rotating body 71 rotates stably regardless of the angle at which the guide wire 1A contacts the wall surface 55 in the living lumen, and the tip of the guide wire 1A and the wall surface 55 in the living lumen 55. The frictional resistance between them can be reduced.

Next, a modified example of the support portion of the present embodiment will be described with reference to the drawings.
FIG. 18 is a cross-sectional view showing a first modification of the support portion of the present embodiment.
In FIG. 18, for convenience of explanation, the coil 4 is shown as a cross-sectional view, and the support portion 72G (cylindrical member) is shown as a perspective view.

The support portion 72G of this modification is a cylindrical member. A circular opening 724G is provided on the tip end side of the support portion 72G. A bottom surface portion 721G is provided on the base end side of the support portion 72G. The bottom surface portion 721G of the support portion 72G has a circular shape. Inside the support portion 72G, a space 725G extending from the opening 724G toward the bottom surface portion 721G is formed. The diameter of the space 725G when viewed along the shaft 11 may be the same along the shaft 11 or may decrease from the tip end to the base end. As described above, the support portion 72G of the present modification has a cylindrical shape in which the front end side portion is opened as the opening portion 724G and the base end side portion is closed as the bottom surface portion 721G.

The support portion 72G is fixed to the coil 4 and the first wire 2A by solder (wax material), an adhesive, or the like inside the coil 4. Specifically, the support portion 72G is fixed to the inner peripheral surface of the coil 4 and the flat plate portion 26 of the first wire 2A. The flat plate portion 26 of the first wire 2A is fixed to the bottom surface portion 721G of the support portion 72G with an adhesive in a state where the tip portion thereof is inserted into the bottom surface portion 721G of the support portion 72G. The support portion 72G supports the outer peripheral portion of the tip rotating body 71 by receiving it at the edge of the opening 724G.

As shown in FIG. 18, the outer diameter and the inner diameter of the tip portion of the coil 4 provided with the tip rotating body 71 are reduced toward the tip side. The tip rotating body 71 is provided between the tip portion of the coil 4 whose outer diameter and inner diameter are reduced and the support portion 72G. A part of the tip rotating body 71 projects outward from the surface of the coil 4. The other part of the tip rotating body 71 is housed inside the coil 4. It should be noted that the coil 4 need only have its inner diameter reduced, and its outer diameter does not have to be reduced.

According to this modification, the support portion 72G can have a simple structure in which the cylindrical member is fixed to the inner peripheral surface of the coil 4. Further, since the support portion 72G is fixed to the wire main body 10 (specifically, the flat plate portion 26 of the first wire 2A), the torque transmissibility of the guide wire 1A is ensured.

FIG. 19 is a cross-sectional view showing a second modification of the support portion of the present embodiment.
FIG. 20 is a cross-sectional view showing a third modification of the support portion of the present embodiment.
The support portions 4A and 4B shown in FIGS. 19 and 20 are coils formed by spirally winding a wire 43. The support portions 4A and 4B shown in FIGS. 19 and 20 are examples of the "second coil" of the present invention. Further, the coil 4 arranged on the outer periphery of the tip of the wire body 10 and covering the tip of the wire body 10 shown in FIGS. 19 and 20 is an example of the "first coil" of the present invention.

The support portions 4A and 4B cover at least a part of the wire body 10 (specifically, the first wire 2), and the inner peripheral surface of the coil 4 and the inner peripheral surface of the coil 4 are provided by a fixing material 59 such as solder (wax material) or an adhesive. It is fixed to both of the wire bodies 10. Alternatively, the support portions 4A and 4B may be fixed to the wire body 10 or may be fixed to the coil 4. That is, the support portions 4A and 4B are fixed to at least one of the coil 4 and the wire body 10.

As shown in FIGS. 19 and 20, the support portions 4A and 4B are fixed to the inner peripheral surface of the coil 4 and the wire body 10 at two points by the fixing material 59. The tip portions of the support portions 4A and 4B are fixed to both the inner peripheral surface of the coil 4 and the wire body 10 in the vicinity of the tip rotating body 71. The base ends of the support portions 4A and 4B are fixed to both the inner peripheral surface of the coil 4 and the wire body 10 at the base ends of the support portions 4A and 4B. The fixing points and the fixed number of the support portions 4A and 4B to the coil 4 and the wire main body 10 are not limited to this.

As shown in FIG. 19, the support portion 4A receives the tip rotating body 71 at the tip portion. The support portion 4B receives the tip rotating body 71 at the tip portion (the portion where the outer diameter is expanded). As shown in FIG. 20, the outer diameter of the tip portion of the support portion 4B may increase toward the tip end side.

As shown in FIGS. 19 and 20, the outer diameter and inner diameter of the tip portion of the coil 4 provided with the tip rotating body 71 are reduced toward the tip side. The tip rotating body 71 is provided between the tip of the coil 4 whose outer diameter and inner diameter are reduced and the tip of the support portions 4A and 4B. A part of the tip rotating body 71 projects outward from the surface of the coil 4. The other part of the tip rotating body 71 is housed inside the coil 4.

As shown in FIGS. 19 and 20, the tip of the wire body 10 is separated from the tip rotating body 71.

According to the support portion 4A of the second modification described above with respect to FIG. 19 and the support portion 4B of the third modification described above with respect to FIG. 20, the support portions 4A and 4B are formed by spirally winding the wire 43. It is a coil (second coil). The tip rotating body 71 is supported by the tip portions of the support portions 4A and 4B. Since the support portions 4A and 4B, which are coils, are flexible and elastic, the tip rotating body 71 is the shaft of the guide wire 1 according to the pushing amount of the tip rotating body 71 supported by the tip portions of the support portions 4A and 4B. It can move in 11 directions. Therefore, the tip of the guide wire 1 is excellent in flexibility. Further, since the support portions 4A and 4B are fixed to both the inner peripheral surface of the coil 4 and the wire body 10, the guide wire 1 is excellent in torque transmission. Since the fixing material 59 is provided near the tip rotating body 71, the support portions 4A and 4B are fixed near the tip of the wire body 10. Therefore, the torque transmissibility of the guide wire 1 is ensured. Further, since the tip of the wire body 10 is separated from the tip rotating body 71, the tip rotating body 71 can rotate smoothly. As shown in FIG. 20, when the outer diameter of the tip portion of the support portion 4B increases toward the tip side, the support portion 4B can support the tip rotating body 71 more stably.

Next, the guide wire according to another embodiment of the present invention will be described with reference to the drawings.
When the components of the guide wires 1B and 1C according to other embodiments of the present invention are the same as the components of the guide wires 1 according to the above-described embodiment with respect to FIGS. 1 to 9, they overlap. The description will be omitted as appropriate, and the differences will be mainly described below.

FIG. 21 is a cross-sectional view showing a guide wire according to a second embodiment of the present invention.
FIG. 22 is an example of a cross-sectional view of the cut planes C3-C3 shown in FIG.

The guide wire 1B according to the present embodiment includes a wire main body 10, a covering portion (outer layer portion) 4C that covers the tip end portion of the wire main body 10, a tip rotating body 71, and a side rotating body 73. That is, the guide wire 1B according to the present embodiment is an example in which the "rotating body" of the present invention includes a "tip rotating body" and a "side rotating body". The “covered portion” of the present embodiment is an example of the “outer layer portion” of the present invention. The wire body 10 is as described above with respect to FIG. However, the shape of the wire body 10 of the guide wire 1B according to the present embodiment does not necessarily have to be the same as the shape of the wire body 10 described above with respect to FIG.

The covering portion 4C is formed of a resin material. Examples of the resin material forming the coating portion 4C include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, silicone resin, polyurethane elastomer, polyester elastomer, polyamide elastomer and the like. Examples thereof include various rubber materials such as thermoplastic elastomers, latex rubbers, and silicone rubbers, or composite materials such as polymer alloys or polymer blends in which two or more of them are combined. Further, the covering portion 4C may have a structure (laminated structure) in which a plurality of layers are stacked. It is preferable that the covering portion 4C is flexible enough not to interfere with the bending of the wire body 10, and the outer surface is a smooth surface without unevenness.

The resin material constituting the covering portion 4C preferably contains an X-ray opaque substance. Examples of the X-ray opaque substance include elemental metals such as tungsten, barium sulfate, bismuth, gold, and platinum, or alloys, and fine particles made of compounds. The particle size of the X-ray opaque substance is preferably 1 to 4 μm. The content of the X-ray opaque substance in the synthetic resin is 70% by weight or more, and particularly preferably 70 to 85% by weight. More preferably, it is 75 to 85% by weight.

The surface of the coating portion 4C is preferably coated with a hydrophilic material. Examples of the hydrophilic material of the coating portion 4C include the hydrophilic material of the resin coating layer 8 described above with respect to FIG.

The tip rotating body 71 and the side rotating body 73 are provided at the tip of the covering portion 4C. Specifically, the tip rotating body 71 is provided at the tip of the covering portion 4C. The side rotating body 73 is provided on the side (outer peripheral portion) of the covering portion 4C. The tip rotating body 71 and the side rotating body 73 are rotatably fitted in the hole portion 41C formed in the tip portion of the covering portion 4C. The constituent materials of the tip rotating body 71 are as described above with respect to FIG. The constituent material of the side rotating body 73 is the same as the constituent material of the tip rotating body 71. The lateral rotating body 73 is a sphere or a rotating ellipsoid. Each of the tip rotating body 71 and the side rotating body 73 of the guide wire 1B shown in FIGS. 21 and 22 is a sphere. The range in which the side rotating body 73 is provided is preferably about 25 cm from the tip of the guide wire 1B to the proximal end side, and more preferably about 1 cm from the distal end of the guide wire 1B to the proximal end side. The number of lateral rotating bodies 73 provided on the outer peripheral portion of the covering portion 4C in the cross section when cut in a plane intersecting the shaft 11 is not particularly limited, and is as shown in FIG. It may be four, three or less, or five or more.

According to the guide wire 1B according to the present embodiment, a part of the tip rotating body 71 and the side rotating body 73 protrudes or is exposed outward from the surface of the covering portion 4C. Then, the tip rotating body 71 and the side rotating body 73 rotate when they come into contact with a portion in the living lumen (for example, a wall surface or a narrowed portion) and receive an external force. As a result, in the guide wire 1B according to the present embodiment, the frictional resistance between the tip and side surfaces of the covering portion 4C and the portion of the biological lumen is reduced, and the operability of the guide wire 1B is reduced. It can be suppressed. Further, the tip rotating body 71 and the side rotating body 73 rotate by coming into contact with the wall surface 55 in the living lumen and receiving an external force even if magnetic or electrical power is not supplied. Thereby, the guide wire 1B according to the present embodiment can reduce the frictional resistance between the covering portion 4C and the wall surface 55 in the living lumen by a simple structure.

Further, the guide wire 1B according to the present embodiment reduces the frictional resistance at the tip of the guide wire 1B. As a result, the tip of the guide wire 1B is less likely to be caught in the narrowed portion or the stent in the living lumen, and the guide wire 1B is suppressed from being lowered in operability and bending of the guide wire 1B.

Further, in the guide wire 1B according to the present embodiment, the side rotating body 73 is provided in the covering portion 4C in a range of about 1 cm from the tip end side of the guide wire 1B to the proximal end side. The range from the tip of the guide wire 1B to about 1 cm toward the proximal end comes into contact with the blood vessel wall when the operator deforms (reshapes) the tip of the guide wire 1B into a curved shape in order to improve blood vessel selectivity. This is the part that is likely to be done. Therefore, when the operator deforms the tip of the guide wire 1B into a curved shape, the guide wire 1B according to the present embodiment has frictional resistance between the lateral surface of the covering portion 4C and the portion of the biological lumen. Is reduced, and the deterioration of the operability of the guide wire 1B is suppressed.

FIG. 23 is a plan view showing a guide wire according to a third embodiment of the present invention.
FIG. 24 is an enlarged view of the region A11 shown in FIG. 23.
FIG. 25 is a plan view when viewed from the direction of arrow A9 shown in FIG. 24.
FIG. 26 is a cross-sectional view of the cut planes C4-C4 shown in FIG. 24.

The guide wire 1C according to the present embodiment includes a wire main body 10, a tubular member (outer layer portion) 4D, a tip rotating body 71, a side rotating body 73, and a support film 47. That is, the guide wire 1C according to the present embodiment is an example in which the "rotating body" of the present invention includes a "tip rotating body" and a "side rotating body". The "cylindrical member" of the present embodiment is an example of the "outer layer portion" of the present invention. The tip of the tubular member 4D is fixed to the tip of the wire body 10 by a fixing material 51 such as solder (wax) or an adhesive. The base end portion of the tubular member 4D is fixed in the middle of the wire body 10 by a fixing material 53 such as solder (wax material) or an adhesive. The shape and constituent materials of the wire body 10 are as described above with respect to FIG. However, the shape of the wire body 10 of the guide wire 1C according to the present embodiment does not necessarily have to be the same as the shape of the wire body 10 described above with respect to FIGS. 1 and 15.

The tubular member 4D is manufactured by processing, for example, a metal pipe or the like. As the metal used for forming the tubular member 4D, a metal having biocompatibility is preferable, and for example, cobalt such as stainless steel, tantalum or tantalum alloy, platinum or platinum alloy, gold or gold alloy, and cobalt-chromium alloy. Examples include base alloys and nickel-titanium alloys. The tip of the first wire 2 is inserted into the internal space of the tubular member 4D. A slit 45 is formed on the outer peripheral portion of the tubular member 4D to connect the internal space of the tubular member 4D and the external space of the tubular member 4D. As shown in FIGS. 24 to 26, the tubular members 4D adjacent to each other via the slit 45 are connected by a link portion 46. As a result, the tubular member 4D can have flexibility, and the blood vessel followability is ensured. The number of link portions 46 when viewed along the circumferential direction of the tubular member 4D is not limited to two, and may be three or more.

The tip rotating body 71 and the side rotating body 73 are provided at the tip portion of the tubular member 4D. Specifically, the tip rotating body 71 is provided at the tip of the tubular member 4D in a state in which a part of the tip rotating body 71 projects outward from the surface of the support portion 72. The side rotating body 73 is rotatably provided while being sandwiched between the support film 47 and the tubular member 4D. As shown in FIGS. 24 and 26, a part of the side rotating body 73 projects to the outside of the tubular member 4D through the slit 45 of the tubular member 4D. That is, the side rotating body 73 is provided in the portion of the slit 45. The constituent materials of the tip rotating body 71 are as described above with respect to FIG. The constituent material of the side rotating body 73 is the same as the constituent material of the tip rotating body 71. The lateral rotating body 73 is a sphere or a rotating ellipsoid. Each of the tip rotating body 71 and the side rotating body 73 of the guide wire 1C shown in FIG. 23 is a sphere.

The range in which the side rotating body 73 is provided is preferably about 25 cm from the tip of the guide wire 1C to the proximal end side, and more preferably about 1 cm from the distal end of the guide wire 1C to the proximal end side. However, the installation position of the side rotating body 73 is not limited to the example shown in FIG. 23, and may be provided from the tip end portion to the base end portion of the tubular member 4D. Further, in the guide wire 1C shown in FIG. 23, the side rotating body 73 is continuously provided in the portion of the slit 45 along the shaft 11 of the wire main body 10. However, the installation position of the side rotating body 73 is not limited to the example shown in FIG. 23, and may be provided in the slit 45 portion at intervals along the axis 11 of the wire main body 10. For example, when viewed along the shaft 11 of the wire body 10, even if the slit 45 provided with the side rotating body 73 and the slit 45 not provided with the side rotating body 73 are alternately arranged. Good. In this case, the flexibility of the portion of the guide wire 1C provided with the tubular member 4D is further increased as compared with the case where the side rotating body 73 is continuously provided in the portion of the slit 45. .. Further, in the guide wire 1C shown in FIG. 23, the lateral rotating bodies 73 adjacent to each other in the axial direction of the guide wire 1C are provided at the same positions in the circumferential direction of the tubular member 4D. However, the installation positions of the lateral rotating bodies 73 adjacent to each other in the axial direction of the guide wire 1C are not limited to the example shown in FIG. 23, and may be provided at different positions in the circumferential direction of the tubular member 4D. ..

The tip rotating body 71 is provided at the tip (portion of the fixing material 51) of the guide wire 1C by using, for example, the support portion 72 described above with respect to FIGS. 5 and 6. That is, in the guide wire 1C shown in FIG. 23, the tip unit 7 is fixed to the tip of the tubular member 4D and the wire body 10 by a fixing material 51 such as solder (wax material) or an adhesive. The details of the tip unit 7 are as described above with respect to FIGS. 5 and 6.

The support film 47 is, for example, a tubular body such as a tube, and is fixed inside the tubular member 4D. The support film 47 receives and supports the side rotating body 73 in a state in which the side rotating body 73 is rotatable. Examples of the material of the support film 47 include various urethane-based rubber materials such as polyurethane and polyurethane elastomer, and composite materials such as a polymer alloy or a polymer blend in which a plurality of rubber materials are combined.

As shown in FIG. 25, the width L6 of the slit 45 in the axis 11 direction is smaller than the diameter D1 of the side rotating body 73. Therefore, the lateral rotating body 73 is prevented from falling off to the outside of the tubular member 4D through the slit 45. Further, inside the slit 45, an arc portion 48 formed as a part of the circumference is provided. The arc portion 48 has an inner diameter D2 smaller than the diameter D1 of the side rotating body 73, and holds the side rotating body 73. That is, the side rotating body 73 is arranged at the position of the arc portion 48 in the slit 45, and the arc portion 48 suppresses the movement in the direction of the shaft 11 or the circumferential direction of the tubular member 4D.

According to the guide wire 1C according to the present embodiment, a part of the tip rotating body 71 and the side rotating body 73 protrudes or is exposed outward from the surface of the tubular member 4D. Then, the tip rotating body 71 and the side rotating body 73 rotate when they come into contact with a portion in the living lumen (for example, a wall surface or a narrowed portion) and receive an external force. As a result, in the guide wire 1C according to the present embodiment, the frictional resistance between the tip and side surfaces of the tubular member 4D and the portion of the biological lumen is reduced, and the operability of the guide wire 1C is reduced. Is suppressed. Further, the tip rotating body 71 and the side rotating body 73 rotate by coming into contact with the wall surface 55 in the living lumen and receiving an external force even if magnetic or electrical power is not supplied. Thereby, the guide wire 1C according to the present embodiment can reduce the frictional resistance between the tubular member 4D and the wall surface 55 in the biological lumen by a simple structure.

Further, the guide wire 1C according to the present embodiment reduces the frictional resistance at the tip of the guide wire 1C. As a result, the tip of the guide wire 1C is less likely to be caught in the narrowed portion or the stent in the living lumen, and the guide wire 1C is suppressed from being lowered in operability and bending of the guide wire 1C.

Further, in the guide wire 1C according to the present embodiment, the side rotating body 73 is provided in a range of about 1 cm from the tip end side of the guide wire 1C to the proximal end side of the tubular member 4D. The range from the tip of the guide wire 1C to about 1 cm toward the proximal end comes into contact with the blood vessel wall when the operator deforms (reshapes) the tip of the guide wire 1C into a curved shape in order to improve blood vessel selectivity. This is the part that is likely to be done. Therefore, when the operator deforms the tip of the guide wire 1C into a curved shape, the guide wire 1C according to the present embodiment has friction between the lateral surface of the tubular member 4D and the portion of the biological lumen. The resistance is reduced, and the deterioration of the operability of the guide wire 1C is suppressed.

The embodiment of the present invention has been described above. However, the present invention is not limited to the above embodiment, and various modifications can be made without departing from the scope of claims. The configuration of the above embodiment may be partially omitted or may be arbitrarily combined so as to be different from the above.

1, 1A, 1B, 1C ... Guide wire, 2, 2A ... 1st wire, 3 ... 2nd wire, 4 ... Coil, 4A, 4B ... Support part, 4C ... Coating part, 4D ... Cylindrical member, 6 ... Joint part, 7, 7A, 7B, 7C, 7D, 7E, 7F ... Tip unit, 8, 9 ... Resin coating layer, 10 ...・ Wire body, 11 ・ ・ ・ Shaft, 21 ・ ・ ・ 1st diameter constant part, 22 ・ ・ ・ 1st taper part, 23 ・ ・ ・ 2nd diameter constant part, 24 ・ ・ ・ 2nd taper part, 25 ・・ ・ Third diameter constant part, 26 ・ ・ ・ flat plate part, 41 ・ ・ ・ wire, 41C ・ ・ ・ hole part, 43 ・ ・ ・ wire, 45 ・ ・ ・ slit, 46 ・ ・ ・ link part, 47・ ・ ・ Support membrane, 48 ・ ・ ・ Arc part, 51, 53 ・ ・ ・ Fixing material, 55 ・ ・ ・ Wall surface, 56 ・ ・ ・ Narrow part, 57 ・ ・ ・ Mineralized lesion, 58 ・ ・ ・ Strut, 59 ... Fixed material, 71, 71F ... Tip rotating body, 72, 72A, 72B, 72C, 72D, 72E, 72F, 72G, 72H ... Support part, 73 ... Lateral rotating body, 711.・ ・ Long axis, 721 ・ ・ ・ pedestal bottom part, 721G ・ ・ ・ bottom part, 722, 722B, 722C, 722D, 722E, 722F ・ ・ ・ pedestal side part, 724, 724D, 724F, 724G ・ ・ ・ opening , 725, 725G ... Space, 726, 726H ... Joint, 727, 727F ... Pedestal ring

Claims (12)

With a long wire body,
An outer layer portion that is arranged on the outer circumference of the tip portion of the wire body and covers the tip portion, and
A rotating body whose part protrudes toward the outside of the outer layer portion and rotates when it comes into contact with a portion inside the living lumen and receives an external force.
A guide wire characterized by being equipped with. The first aspect of the present invention is characterized in that the rotating body includes at least one of a tip rotating body provided at the tip of the outer layer portion and a lateral rotating body provided on the side of the outer layer portion. Described guide wire. The wire body has a flat plate portion provided on the tip end side of the wire body, and has a flat plate portion.
The tip rotating body is a rotating ellipsoid formed when an ellipse is rotated about a major axis or a minor axis.
The guide wire according to claim 2, wherein the long axis of the spheroid is parallel to the main surface of the flat plate portion. The guide wire according to claim 2 or 3, further comprising a support portion fixed to at least one of the wire main body and the outer layer portion and supporting the tip rotating body. The support portion
The bottom surface of the pedestal that receives the tip rotating body and
A tapered pedestal that is connected to the edge of the bottom surface of the pedestal, covers the periphery of the rotating tip, accommodates at least a part of the rotating tip together with the bottom surface of the pedestal, and shrinks in outer shape toward the tip side. Side part and
An opening for projecting the part of the tip rotating body and
The guide wire according to claim 4, wherein the guide wire has. The guide wire according to claim 5, wherein the support portion further has a joint portion extending from the bottom surface portion of the pedestal and fixed to the outer layer portion. The guide wire according to claim 5 or 6, wherein the support portion further has a pedestal ring portion fixed to the pedestal side surface portion and receiving an outer peripheral portion of the tip rotating body. The outer layer portion is a coil formed by spirally winding a wire.
The guide wire according to claim 4, wherein the support portion is a cylindrical member fixed to the coil and having an opening for receiving an outer peripheral portion of the tip rotating body. The outer layer portion is a first coil formed by spirally winding a wire.
The support portion is a second coil formed by spirally winding a wire and covering at least a part of the wire body.
The guide wire according to claim 4, wherein the second coil receives the tip rotating body at the tip. The outer layer portion is a covering portion that covers the tip end portion of the wire body.
The guide wire according to any one of claims 1 to 3, wherein the rotating body is rotatably fitted in a hole formed in the covering portion. The outer layer portion is a tubular member having an internal space through which the tip end portion of the wire body is inserted and having a slit connecting the internal space and the external space.
The tubular members adjacent to each other via the slit are connected by a link portion.
The lateral rotating body is rotatably provided while being sandwiched between the tubular member and a support film fixed inside the tubular member.
The guide wire according to claim 2 to 7, wherein a part of the lateral rotating body projects to the outside of the tubular member through the slit. The tubular member has an arc portion provided at a position of the lateral rotating body inside the slit.
The guide wire according to claim 11, wherein the width of the slit and the inner diameter of the arc portion are smaller than the diameter of the lateral rotating body.

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