Medical devices

Abstract

Simplify the configuration of medical devices. [Solution] The medical device disclosed in this embodiment comprises a core shaft, an outer layer coil, a tip, a fixing part, and an inner layer coil. The outer layer coil is located outside the core shaft. The tip fixes the tip of the core shaft to the tip of the outer layer coil. The fixing part is located on the proximal end side of the tip. The fixing part fixes the core shaft to the outer layer coil. The inner layer coil is located outside the core shaft. The inner layer coil is located inside the outer circumference of the outer layer coil. The inner layer coil contains a radiopaque base metal. The inner layer coil is located between the tip and the fixing part. The inner layer coil is not fixed by the tip and the fixing part. Both ends of the inner layer coil are free ends.

Description

Technical Field

[0001] The technology disclosed in this specification relates to medical devices.

Background Art

[0002] A guide wire, which is a medical device, is used, for example, when treating a lesion in a biological lumen such as a blood vessel or a digestive organ. The guide wire has a core shaft, an outer layer coil located outside the core shaft, a tip chip that fixes the tip of the core shaft and the tip of the outer layer coil, and a fixing portion that is located on the proximal side of the tip chip and fixes the core shaft and the outer layer coil.

[0003] Known guide wires include an inner layer coil having radiopacity. Further, known guide wires have a distal stopper and a proximal stopper to restrict the movement of the inner layer coil (see, for example, Patent Document 1).

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Known guide wires have a distal stopper and a proximal stopper. Therefore, the configuration of the guide wire is complicated.

[0006] This specification discloses a technology capable of solving the above problems.

Means for Solving the Problems

[0007] The technology disclosed in this specification can be realized, for example, in the following forms.

[0008] The medical device disclosed in this embodiment comprises a core shaft, an outer layer coil, a tip, a fixing part, and an inner layer coil. The outer layer coil is located outside the core shaft. The tip fixes the tip of the core shaft to the tip of the outer layer coil. The fixing part is located proximal to the tip. The fixing part fixes the core shaft to the outer layer coil. The inner layer coil is located outside the core shaft. The inner layer coil is located inside the outer circumference of the outer layer coil. The inner layer coil contains a radiopaque base metal. The inner layer coil is located between the tip and the fixing part. The inner layer coil is not fixed by the tip and the fixing part. Both ends of the inner layer coil are free ends. [Brief explanation of the drawing]

[0009] [Figure 1] An explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10 in the first embodiment. [Figure 2] Explanatory diagram showing the cross-section (XY section) of the guide wire 10 in the first embodiment. [Figure 3] An explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10a in the second embodiment. [Figure 4] Explanatory diagram showing the cross-section (XY section) of the guide wire 10a in the second embodiment. [Figure 5] An explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10b in the third embodiment. [Figure 6] An explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10c in the fourth embodiment. [Figure 7] An explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10d in the fifth embodiment. [Figure 8] An explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10e in the sixth embodiment. [Modes for carrying out the invention]

[0010] (First Embodiment) (Configuration of guide wire 10) Figure 1 is an explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10 in the first embodiment. Figure 2 is an explanatory diagram showing the cross section (XY section) of the guide wire 10 in the first embodiment.

[0011] The positive Z-axis side of the guidewire 10 is the distal end (tip) that is inserted into the body. The negative Z-axis side of the guidewire 10 is the proximal end (proximal) that is manipulated by the surgeon. In the guidewire 10 and its components, "tip" means the tip end, "tip portion" means the tip and its vicinity, "proximal end" means the proximal end, and "proximal portion" means the proximal end and its vicinity. In the guidewire 10 and its components, "longitudinal section" means a section parallel to the central axis Ax of the guidewire 10, and "transverse section" means a section perpendicular to the central axis Ax of the guidewire 10. In the guidewire 10 and its components, "radial direction" means the direction perpendicular to the central axis in the longitudinal direction.

[0012] The guidewire 10 is a long medical device. The guidewire 10 is used, for example, to guide a catheter to a lesion in a biological lumen.

[0013] The guidewire 10 includes a core shaft 40, an outer layer coil 100, a tip 50, a base end fixing portion 61, an intermediate fixing portion 62, and an inner layer coil 200. Hereinafter, the base end fixing portion 61 and the intermediate fixing portion 62 will be collectively referred to as fixing portions 61 and 62.

[0014] The core shaft 40 is a long, rectangular member. The core shaft 40 has a narrow diameter section 43, a tapered section 42, and a wide diameter section 41. The tip of the narrow diameter section 43 is the same as the tip of the core shaft 40. The tapered section 42 has an outer diameter that increases from the tip to the base end. The tip of the tapered section 42 is connected to the base end of the narrow diameter section 43. The tip of the wide diameter section 41 is connected to the base end of the tapered section 42. The position of the base end of the wide diameter section 41 is the same as the position of the base end of the core shaft 40. The shape of the outer edge of the cross-section of the core shaft 40 is, for example, approximately circular. The shape of the outer edge of the cross-section may differ for each part of the core shaft 40. For example, metal can be used as the forming material for the core shaft 40. More specifically, the core shaft 40 can be made from materials such as stainless steel (SUS302, SUS304, SUS316, etc.), Ni-Ti alloy, or piano wire.

[0015] The outer layer coil 100 is a coil-shaped member formed into a hollow cylindrical shape by spirally winding individual wires. The outer layer coil 100 is, for example, a tightly wound coil. The outer layer coil 100 is located outside the core shaft 40 in the radial direction of the guide wire 10 and is located at the outermost part of the guide wire 10. The base end of the outer layer coil 100 is connected to the middle part of the core shaft 40. As the material for forming the outer layer coil 100, for example, a radiopaque material is used. Examples of materials for forming the outer layer coil 100 include stainless steel (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, and Co-Cr alloys. The outer layer coil 100 may be formed from the same material throughout. The outer layer coil 100 may be formed from different materials in different parts.

[0016] The tip 50 fixes the tip of the core shaft 40 to the tip of the outer layer coil 100. The position of the tip of the tip 50 is the same as the position of the tip of the guide wire 10. As the material for forming the tip 50, for example, brazing material (aluminum alloy brazing, silver brazing, gold brazing, etc.), metal solder (Ag-Sn alloy, Au-Sn alloy, etc.), adhesive (epoxy adhesive, etc.) can be used.

[0017] The fixing parts 61 and 62 fix the core shaft 40 and the outer layer coil 100. The fixing parts 61 and 62 are located on the base end side with respect to the tip chip 50. At least one of the base end side fixing part 61 and the intermediate fixing part 62 is an example of the fixing parts 61 and 62. The intermediate fixing part 62 fixes the intermediate part of the outer layer coil 100 and the intermediate part of the core shaft 40. The base end side fixing part 61 fixes the base end of the outer layer coil 100 and the intermediate part of the core shaft 40. The base end side fixing part 61 is located on the base end side with respect to the intermediate fixing part 62. As the forming material of the fixing parts 61 and 62, for example, brazing materials (such as aluminum alloy brazing, silver brazing, gold brazing, etc.), metal solder (such as Ag-Sn alloy, Au-Sn alloy, etc.), adhesives (such as epoxy-based adhesives, etc.) are used.

[0018] The inner layer coil 200 is a coil-shaped member formed in a hollow cylindrical shape by winding a strand wire in a spiral shape. The inner layer coil 200 is, for example, a closely wound coil. The inner layer coil 200 is located outside the core shaft 40 in the radial direction of the guide wire 10. The inner layer coil 200 is not arranged outside the outer layer coil 100 in the radial direction of the guide wire 10. The outer diameter OD200 of the inner layer coil 200 is smaller than the outer diameter OD100 of the outer layer coil 100 over the entire length of the guide wire 10 in the long axis direction of the guide wire 10. At this time, a second circumscribed circle C200 is formed by connecting the points having the maximum outer diameter from the central axis Ax to the inner layer coil 200. Hereinafter, the second circumscribed circle C200 means the outer circumference of the inner layer coil 200. A first circumscribed circle C100 is formed by connecting the points having the maximum outer diameter from the central axis Ax to the outer layer coil 100. Hereinafter, the first circumscribed circle C100 means the outer circumference of the outer layer coil 100. At this time, the second circumscribed circle C200 is located inside the first circumscribed circle C100 in the radial direction of the guide wire 10. In other words, the inner layer coil 200 is located inside the outer circumference of the outer layer coil 100 in the radial direction of the guide wire 10.

[0019] (Detailed configuration of the guide wire 10) The inner layer coil 200 of the present embodiment is positioned between the tip chip 50 and the fixing parts 61 and 62. The inner layer coil 200 is not fixed by the tip chip 50 and the fixing parts 61 and 62. Both ends of the inner layer coil 200 are free ends. A free end is an end that is not fixed by other members. The position of the inner layer coil 200 is on the proximal end side from the position of the tip chip 50. The tip of the inner layer coil 200 and the base end of the tip chip 50 may be in contact. In other words, the inner layer coil 200 can be in contact with the tip chip 50. The position of the proximal end 200P of the inner layer coil 200 is on the distal end side from the position of the proximal end 100P of the outer layer coil 100. More specifically, the position of the proximal end 200P of the inner layer coil 200 is at least one of the position of the tip 62D of the intermediate fixing part 62 and a position on the distal end side from the position of the tip 62D of the intermediate fixing part 62. As the material for forming the inner layer coil 200, for example, a base metal with radiation impermeability is used. A base metal is a metal having an ionization tendency greater than that of hydrogen. Examples of the material for forming the inner layer coil 200 include tungsten, tin, bismuth, rhenium, etc. The inner layer coil 200 may be formed of the same material throughout. The inner layer coil 200 may be formed of mutually different materials for each part. In the present embodiment, tungsten is used as the material for forming the inner layer coil 200.

[0020] The strands of the inner layer coil 200 are twisted between the strands of the outer layer coil 100. In other words, in at least a part of the guide wire 10 in the long axis direction of the guide wire 10, the outer diameter OD200 of the inner layer coil 200 is larger than the inner diameter ID100 of the outer layer coil 100. In a part where the outer diameter OD200 of the inner layer coil 200 is larger than the inner diameter ID100 of the outer layer coil 100, the difference between the outer diameter OD200 of the inner layer coil 200 and the inner diameter ID100 of the outer layer coil 100 (hereinafter referred to as "the first difference") is, for example, 0.01 times or more and 0.95 times or less of the strand diameter of the outer layer coil 100 (hereinafter referred to as "the first width"). The above first difference may be 0.05 times or more and 0.70 times or less of the above first width, or may be 0.10 times or more and 0.50 times or less of the above first width.

[0021] (Method of manufacturing guide wire 10) The guide wire 10 is manufactured, for example, by the following method. First, the worker prepares the core shaft 40. Next, the worker places the inner layer coil 200 on the outside of the core shaft 40, and the outer layer coil 100 on the outside of the inner layer coil 200. Next, the worker supplies the material for forming the tip tip 50 and fixing parts 61 and 62 to the positions where the tip tip 50 and fixing parts 61 and 62 will be formed, and performs heat treatment. This forms the tip tip 50 and fixing parts 61 and 62 that join the outer layer coil 100 and the core shaft 40. The outer layer coil 100 and the core shaft 40 are joined by the tip tip 50 and fixing parts 61 and 62. The material of the inner layer coil 200 is tungsten. Tungsten has the property of not joining with members formed from materials such as brazing material or metal solder. Therefore, the inner layer coil 200 is not joined to the tip tip 50 and fixing parts 61 and 62. Therefore, the tip of the inner coil 200 is not fixed by the tip 50. The base end of the inner coil 200 is not fixed by the fixing parts 61 and 62. In other words, both ends of the inner coil 200 are free ends. The guide wire 10 of this embodiment is manufactured by the method described above.

[0022] (Effects of the first embodiment) As described above, the guide wire 10 of this embodiment includes a core shaft 40, an outer layer coil 100, a tip 50, fixing parts 61 and 62, and an inner layer coil 200. The outer layer coil 100 is located outside the core shaft 40. The tip 50 fixes the tip of the core shaft 40 to the tip of the outer layer coil 100. The fixing parts 61 and 62 are located on the base end side of the tip 50. The fixing parts 61 and 62 fix the core shaft 40 to the outer layer coil 100. The inner layer coil 200 is located outside the core shaft 40. The inner layer coil 200 is located inside the outer circumference of the outer layer coil 100. The inner layer coil 200 contains a radiopaque base metal. The inner layer coil 200 is located between the tip 50 and the fixing parts 61 and 62. The inner layer coil 200 is not fixed by the tip 50 and the fixing parts 61 and 62. Both ends of the inner layer coil 200 are free ends. In this embodiment, there is no stopper to position the inner layer coil 200 in the axial direction. Therefore, the structure of the guide wire 10 can be simplified. Furthermore, there are no joints between the inner layer coil 200 and other members. Therefore, the difference in rigidity in the inner layer coil 200 can be reduced.

[0023] In the guide wire 10 of this embodiment, in at least a portion of the guide wire 10 in the longitudinal direction, the outer diameter OD200 of the inner coil 200 is larger than the inner diameter ID100 of the outer coil 100. Therefore, the strands of the inner coil 200 are sandwiched between the strands of the outer coil 100. Thus, the outer diameter of the guide wire 10 can be reduced. Furthermore, the positional relationship between the strands of the outer coil 100 and the strands of the inner coil 200 is more easily fixed. Therefore, it is possible to suppress the inner coil 200 from being unevenly positioned in the area between the base end 50P of the tip 50 and the tip of the fixing parts 61 and 62.

[0024] In the guide wire 10 of this embodiment, the inner layer coil 200 is capable of contacting the tip 50. In this embodiment, the tip 200D of the inner layer coil 200 can be easily positioned.

[0025] In the guide wire 10 of this embodiment, the position of the base end 200P of the inner layer coil 200 is on the tip side of the position of the base end 100P of the outer layer coil 100. In this embodiment, the accuracy of positioning the base end 200P of the inner layer coil 200 can be improved.

[0026] In this embodiment, the base metal is tungsten. Therefore, the visibility of the guide wire 10 can be improved.

[0027] (Second Embodiment) Figure 3 is an explanatory diagram showing the longitudinal section (YZ section) of the guide wire 10a in the second embodiment. Figure 4 is an explanatory diagram showing the cross section (XY section) of the guide wire 10a in the second embodiment. In the following, for components of the guide wire 10a in the second embodiment that are the same as those of the guide wire 10 in the first embodiment described above, the same reference numerals are used, and their explanations will be omitted as appropriate.

[0028] The guide wire 10a of the second embodiment includes a core shaft 40, an outer layer coil 100, a tip 50, fixing parts 61 and 62, and an inner layer coil 200a.

[0029] The inner coil 200a is located inside the outer coil 100 in the radial direction of the guide wire 10a. In other words, the outer diameter OD200a of the inner coil 200a over the entire length of the guide wire 10a in the longitudinal direction is less than or equal to the inner diameter ID100 of the outer coil 100. The outer diameter OD200a of the inner coil 200a is, for example, 0.10 times or more and 0.99 times or less the inner diameter ID100 of the outer coil 100. The outer diameter OD200a of the inner coil 200a may also be 0.30 times or more and 0.99 times or less the inner diameter ID100 of the outer coil 100, or 0.50 times or more and 0.99 times or less the inner diameter ID100 of the outer coil 100.

[0030] The guide wire 10a of this embodiment, like the guide wire 10 of the first embodiment, is located outside the core shaft 40 and inside the outer circumference of the outer layer coil 100, contains a radiopaque base metal, and has an inner layer coil 200a located between the tip 50 and the fixing parts 61, 62, the inner layer coil 200a is not fixed by the tip 50 and the fixing parts 61, 62. Both ends of the inner layer coil 200a are free ends. In this embodiment, the structure of the guide wire 10a can be simplified. Furthermore, the difference in rigidity in the inner layer coil 200a can be reduced.

[0031] In this embodiment, the guide wire 10a has an outer diameter OD200a of the inner coil 200a that is less than or equal to the inner diameter ID100 of the outer coil 100 along the entire length of the guide wire 10a in the longitudinal direction. In this embodiment, the inner coil 200a is not twisted between the strands of the outer coil 100. Therefore, the positional relationship between the strands of the outer coil 100 and the strands of the inner coil 200a is not fixed. As a result, contact between the strands of the inner coil 200a and the strands of the outer coil 100 is suppressed. Friction between the strands of the inner coil 200a and the strands of the outer coil 100 is suppressed. Thus, the durability of the inner coil 200a and the outer coil 100 can be improved.

[0032] (Third embodiment) Figure 5 is an explanatory diagram showing a longitudinal section (YZ section) of the guide wire 10b in the third embodiment. In the following, for components of the guide wire 10b in the third embodiment that are the same as those of the guide wire 10 in the first embodiment described above, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0033] The guide wire 10b of the third embodiment includes a core shaft 40, an outer layer coil 100, a tip 50, fixing parts 61 and 62, an inner layer coil 200, and a wire 70.

[0034] The wire 70 is a long, elongated member. The wire 70 is positioned to align with the tip of the core shaft 40. Furthermore, the wire 70 is located inside the inner layer coil 200 in the radial direction of the guide wire 10b. The tip of the wire 70 is connected to the tip 50. The base end of the wire 70 is located on the base side of the tip of the intermediate fixing part 62. Furthermore, the base end of the wire 70 is located on the tip side of the base end of the outer layer coil 100. The wire 70 is fixed by the tip 50 and the intermediate fixing part 62. The wire 70 in this embodiment includes stranded wire. Stranded wire is formed by twisting together a plurality of strands. Examples of materials for forming the wire 70 include stainless steel (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, piano wire, Ni-Cr alloys, Co alloys, tungsten, etc.

[0035] The guide wire 10b of this embodiment, like the guide wire 10 of the first embodiment, is located outside the core shaft 40 and inside the outer circumference of the outer layer coil 100, and contains a radiopaque base metal, and has an inner layer coil 200 located between the tip 50 and the fixing parts 61, 62, the inner layer coil 200 is not fixed by the tip 50 and the fixing parts 61, 62. Both ends of the inner layer coil 200 are free ends. In this embodiment, the structure of the guide wire 10b can be simplified. Furthermore, the difference in rigidity in the inner layer coil 200 can be reduced.

[0036] The guide wire 10b of this embodiment further includes a wire 70 arranged to align with the tip of the core shaft 40. Therefore, the tensile strength of the guide wire 10b of this embodiment can be improved.

[0037] The guide wire 10b of this embodiment further includes a wire 70 fixed by a tip 50 and an intermediate fixing portion 62. Therefore, the tensile strength of the tip and base end of the wire 70 can be improved.

[0038] The wire material 70 of the guide wire 10b in this embodiment includes stranded wire. Therefore, the tensile strength of the guide wire 10b in this embodiment can be further improved.

[0039] (Fourth Embodiment) Figure 6 is an explanatory diagram showing a longitudinal section (YZ section) of the guide wire 10c in the fourth embodiment. In the following, for components of the guide wire 10c in the fourth embodiment that are the same as those of the guide wire 10 in the first embodiment described above, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0040] The guide wire 10c of the fourth embodiment includes a core shaft 40, an outer layer coil 100, a tip 50, fixing parts 61 and 62, and an inner layer coil 200c.

[0041] The inner layer coil 200c is formed of radiopaque and radiopaque materials. The region containing the radiopaque material is designated as the first region R1. The region not containing the radiopaque material is designated as the second region R2. The second region R2 contains a radiopaque metal. Examples of radiopaque metals included in the second region R2 include stainless steel (SUS302, SUS304, SUS316, etc.), superelastic alloys such as Ni-Ti alloys, and Co-Cr alloys. The positions of the first region R1 and the second region R2 differ in the longitudinal direction of the guide wire 10c. The first region R1 is located at the tip and base of the inner layer coil 200c. The first region R1 is also located in the middle of the inner layer coil 200c. The first region R1 and the second region R2 are adjacent to each other. The first region R1 and the second region R2 may or may not be joined.

[0042] The guide wire 10c of this embodiment, like the guide wire 10 of the first embodiment, is located outside the core shaft 40 and inside the outer circumference of the outer layer coil 100, contains a radiopaque base metal, and has an inner layer coil 200c located between the tip 50 and the fixing parts 61, 62, the inner layer coil 200c is not fixed by the tip 50 and the fixing parts 61, 62. Both ends of the inner layer coil 200c are free ends. In this embodiment, the structure of the guide wire 10c can be simplified. Furthermore, the difference in rigidity in the inner layer coil 200c can be reduced.

[0043] The inner coil 200c of this embodiment has a first region R1 containing a radiopaque material and a second region R2 not containing a radiopaque material. In this embodiment, under radiation irradiation, the visibility differs for each part of the inner coil 200c. The first region R1 can be provided in the inner coil 200c where identification is required. Therefore, the convenience of the guide wire 10c can be improved.

[0044] In this embodiment, the first region R1 and the second region R2 are positioned at different locations along the long axis of the guide wire 10c. Therefore, under radiation irradiation, the visibility of the inner layer coil 200c from its tip to its base can be ensured.

[0045] In this embodiment, the first region R1 is located at the tip and base of the inner coil 200c. In this embodiment, the operator can distinguish between the tip and base of the inner coil 200c under radiation irradiation. Therefore, the operator can more easily grasp the entire inner coil 200c under radiation irradiation. Thus, the convenience of the guidewire 10c can be further improved.

[0046] (Fifth embodiment) Figure 7 is an explanatory diagram showing a longitudinal section (YZ section) of the guide wire 10d in the fifth embodiment. In the following, for components of the guide wire 10d in the fifth embodiment that are the same as those of the guide wire 10 in the first embodiment described above, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0047] The guide wire 10d of the fifth embodiment includes a core shaft 40, an outer layer coil 100, a tip 50, fixing parts 61 and 62, and an inner layer coil 200d.

[0048] The wire diameters of the inner coil 200d are not the same as those of the guide wire 10d in the longitudinal direction. More specifically, the inner coil 200d has a first part P1 and a second part P2. The wire diameter of the second part P2 is smaller than that of the first part P1. The wire diameter of the first part P1 is, for example, 0.02 mm or more and 1.0 mm or less. The wire diameter of the first part P1 may be 0.05 mm or more and 0.50 mm or less, or 0.05 mm or more and 0.20 mm or less. The wire diameter of the second part P2 is, for example, 0.01 mm or more and 1.0 mm or less. The wire diameter of the second part P2 may be 0.02 mm or more and 0.50 mm or less, or 0.02 mm or more and 0.10 mm or less. The difference between the wire diameter of the first part P1 and the wire diameter of the second part P2 is, for example, 0.01 mm or more and 1.0 mm or less. The difference between the wire diameter of the first part P1 and the wire diameter of the second part P2 may be 0.02 mm or less and 0.50 mm or less, or 0.02 mm or more and 0.10 mm or less. The positions of the first part P1 and the second part P2 are different in the longitudinal direction of the guide wire 10d. The first part P1 is located at the tip and base of the inner layer coil 200d. The first part P1 may be located in the middle of the inner layer coil 200d. The second part P2 is located in the middle of the inner layer coil 200d. The first part P1 and the second part P2 are adjacent to each other. The first part P1 and the second part P2 may or may not be joined.

[0049] The guide wire 10d of this embodiment, like the guide wire 10 of the first embodiment, is located outside the core shaft 40 and inside the outer circumference of the outer layer coil 100, and contains a radiopaque base metal, and has an inner layer coil 200d located between the tip 50 and the fixing parts 61, 62, the inner layer coil 200d is not fixed by the tip 50 and the fixing parts 61, 62. Both ends of the inner layer coil 200d are free ends. In this embodiment, the structure of the guide wire 10d can be simplified. Furthermore, the difference in rigidity in the inner layer coil 200d can be reduced.

[0050] In this embodiment, the inner layer coil 200d has a first portion P1 and a second portion P2. The wire diameter of the second portion P2 is smaller than the wire diameter of the first portion P1. This improves the visibility of the inner layer coil 200d under radiation irradiation. Therefore, the convenience of the guide wire 10d can be further improved.

[0051] In this embodiment, the positions of the first portion P1 and the second portion P2 are different in the longitudinal direction of the guide wire 10d. Therefore, under radiation irradiation, the visibility of the inner layer coil 200d from the tip to the base can be ensured.

[0052] (Sixth Embodiment) Figure 8 is an explanatory diagram showing a longitudinal section (YZ section) of the guide wire 10e in the sixth embodiment. In the following, for components of the guide wire 10e in the sixth embodiment that are the same as those of the guide wire 10 in the first embodiment described above, the same reference numerals are used, and their descriptions will be omitted as appropriate.

[0053] The guide wire 10e of the sixth embodiment includes a core shaft 40, an outer layer coil 100, a tip 50, a base end fixing portion 61, and an inner layer coil 200.

[0054] The guide wire 10e has a base-end fixing portion 61. The guide wire 10e does not have an intermediate fixing portion 62. The position of the base end 200P of the inner layer coil 200 is on the tip side of the position of the base end 100P of the outer layer coil 100.

[0055] The guide wire 10e of this embodiment, like the guide wire 10 of the first embodiment, is located outside the core shaft 40 and inside the outer circumference of the outer layer coil 100, contains a radiopaque base metal, and has an inner layer coil 200 located between the tip 50 and the base end fixing portion 61, the inner layer coil 200 is not fixed by the tip 50 and the base end fixing portion 61. Both ends of the inner layer coil 200 are free ends. According to this embodiment, there is no stopper provided for axial positioning of the inner layer coil 200. There is no intermediate fixing portion 62 provided between the base end 100P of the outer layer coil 100 and the base end 200P of the inner layer coil 200 for positioning the base end 200P of the inner layer coil 200. Therefore, the structure of the guide wire 10e can be further simplified. Furthermore, there are no joints between the inner layer coil 200 and other members. Therefore, the difference in rigidity in the inner layer coil 200 can be reduced.

[0056] (modified version) The technologies disclosed herein are not limited to the embodiments described above and can be modified in various forms without departing from their essence, for example, the following modifications are possible.

[0057] The material used to form the outer layer coil 100 in the above embodiment may include a radiolucent material or a radiopaque material. The outer layer coil 100 in the above embodiment may not be a tightly wound coil, for example, it may be a loosely wound coil. The base end of the outer layer coil 100 in the above embodiment may be connected to a position other than the middle part of the core shaft 40. The material used to form the inner layer coils 200, 200a, 200c, and 200d in the above embodiment may include a radiolucent material. The inner layer coils 200, 200a, 200c, and 200d in the above embodiment may not be a tightly wound coil, for example, it may be a loosely wound coil.

[0058] In the above embodiment, the intermediate fixing portion 62 may fix the portion of the outer layer coil 100 other than the intermediate portion and the portion of the core shaft 40 other than the intermediate portion. In the above embodiment, the base end fixing portion 61 may fix the portion of the outer layer coil 100 other than the base end and the portion of the core shaft 40 other than the intermediate portion.

[0059] In the first embodiment described above, the outer circumference of the outer layer coil 100 and the outer circumference of the inner layer coil 200 may have shapes other than circular.

[0060] The guide wire 10 in the first embodiment described above may have a portion in which the outer diameter OD200 of the inner layer coil 200 is less than or equal to the inner diameter ID100 of the outer layer coil 100.

[0061] In the third embodiment described above, the wire 70 does not have to be fixed by at least one of the tip 50 and the intermediate fixing portion 62. In the third embodiment described above, the wire 70 may include materials other than stranded wire. In the third embodiment described above, the wire 70 may be formed by, for example, a single wire.

[0062] In the fourth embodiment described above, the first region R1 and the second region R2 may overlap in the longitudinal direction of the inner coil 200c. In other words, in the fourth embodiment described above, the positions of the first region R1 and the second region R2 may be the same in the longitudinal direction of the guide wire 10c. In the fourth embodiment described above, the number of first regions R1 and the number of second regions R2 may be one or multiple. In the fourth embodiment described above, the first region R1 and the second region R2 may be located only at the tip of the inner coil 200c or only at the base of the inner coil 200c. In the fourth embodiment described above, the first region R1 and the second region R2 may not be located at the tip of the inner coil 200c or at the base of the inner coil 200c.

[0063] In the fifth embodiment described above, the first portion P1 and the second portion P2 may overlap in the longitudinal direction of the inner coil 200d. In other words, in the fifth embodiment described above, the positions of the first portion P1 and the second portion P2 may be the same in the longitudinal direction of the guide wire 10d. In the fifth embodiment described above, the number of first portions P1 and the number of second portions P2 may be one or multiple. In the fifth embodiment described above, the first portion P1 and the second portion P2 may be positioned at other locations. In the fifth embodiment described above, the position of the first portion P1 may be at a location other than the tip of the inner coil 200d. In the fifth embodiment described above, the position of the first portion P1 may be at a location other than the base of the inner coil 200d. In the fifth embodiment described above, the position of the first portion P1 may be at a location other than the middle of the inner coil 200d. In the fifth embodiment described above, the position of the second portion P2 may be at a location other than the middle of the inner coil 200d.

[0064] In the sixth embodiment described above, the position of the base end 200P of the inner layer coil 200 may be substantially the same as the position of the base end 100P of the outer layer coil 100.

[0065] The materials of each component in the guide wires 10, 10a, 10b, 10c, 10d, and 10e in the above embodiment are merely examples and can be modified in various ways.

Claims

1. It is a medical device, Core shaft (40) and An outer layer coil (100) located outside the core shaft (40), A tip (50) that fixes the tip of the core shaft (40) and the tip of the outer layer coil (100), A fixing portion (61, 62) is located on the proximal end side of the tip (50) and fixes the core shaft (40) and the outer layer coil (100), A medical device comprising: inner layer coils (200, 200a, 200c, 200d) located outside the core shaft (40) and inside the outer circumference of the outer layer coil (100), comprising a radiopaque base metal, located between the tip (50) and the fixing parts (61, 62), and not fixed by the tip (50) and the fixing parts (61, 62), and both ends of the inner layer coils (200, 200a, 200c, 200d) being free ends.

2. A medical device according to claim 1, A medical device wherein, in at least a portion of the medical device in the longitudinal direction, the outer diameter (OD200) of the inner layer coil (200, 200c, 200d) is larger than the inner diameter (ID100) of the outer layer coil (100).

3. A medical device according to claim 1, A medical device in which, over the entire length axis of the medical device, the outer diameter (OD200a) of the inner coil (200a) is less than or equal to the inner diameter of the outer coil (100).

4. A medical device according to any one of claims 1 to 3, The inner layer coils (200, 200a, 200c, 200d) are in contact with the tip (50) of the medical device.

5. A medical device according to any one of claims 1 to 4, A medical device in which the position of the base end (200P) of the inner layer coil (200, 200a, 200c, 200d) is on the tip side of the position of the base end (100P) of the outer layer coil (100).

6. A medical device according to any one of claims 1 to 5, The medical device further comprises a wire (70) arranged in line with the tip of the core shaft (40).

7. A medical device according to claim 6, A medical device in which the wire (70) is fixed by the tip (50) and the fixing part (62).

8. A medical device according to claim 6 or claim 7, The wire (70) is a medical device including stranded wire.

9. A medical device according to any one of claims 1 to 8, The inner layer coil (200c) is a medical device having a first region (R1) containing a radiopaque material and a second region (R2) not containing a radiopaque material.

10. A medical device according to claim 9, A medical device in which the first region (R1) and the second region (R2) are located at different positions in the longitudinal axis direction of the medical device.

11. A medical device according to claim 10, The first region (R1) is located between the tip and base end of the inner layer coil (200c) of the medical device.

12. A medical device according to any one of claims 1 to 11, The inner layer coil (200d) comprises a first portion (P1) and a second portion (P2) having a wire diameter smaller than that of the first portion (P1), in a medical device.

13. A medical device according to claim 12, A medical device in which the first part (P1) and the second part (P2) are positioned at different locations in the longitudinal axis direction of the medical device.

14. A medical device according to any one of claims 1 to 13, The aforementioned base metal is tungsten, in this medical device.

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