GUIDE WIRE

Abstract

Provided is a guide wire including a detection portion, a housing, and a distal end side-covering. The detection portion includes a detection element configured to detect information about a vessel from inside of the vessel, and includes an extension portion extending from the detection element toward a proximal end side of the guide wire. The extension portion is configured to transmit the detected information. The housing includes a first accommodating portion housing the detection element, and includes a second accommodating portion housing the extension portion. The distal end side-covering covers the second accommodating portion. A distal end portion of the distal end side-covering is connected to a proximal end portion of the first accommodating portion.

Claims

1. A guide wire comprising: a detection portion comprising: a detection element configured to detect information about a vessel from inside of the vessel; and an extension portion extending from the detection element toward a proximal end side of the guide wire, and that is configured to transmit the detected information; a housing comprising: a first accommodating portion housing the detection element; and a second accommodating portion housing the extension portion; and a distal end side-covering that covers the second accommodating portion, wherein a distal end portion of the distal end side-covering is connected to a proximal end portion of the first accommodating portion.

2. The guide wire according to claim 1, wherein: an outer diameter of the distal end portion of the distal end side-covering is substantially equal to an outer diameter of the proximal end portion of the first accommodating portion, and the distal end side-covering is arranged coaxially with the first accommodating portion.

3. The guide wire according to claim 1, wherein the second accommodating portion comprises, at a distal end side of the second accommodating portion, a diameter-decreasing portion having an outer diameter gradually decreasing from a proximal end side of the second accommodating portion to the distal end side of the second accommodating portion.

4. The guide wire according to claim 3, wherein the proximal end portion of the first accommodating portion comprises a stepped portion that is engaged with the distal end portion of the distal end side-covering.

5. The guide wire according to claim 1, further comprising: a shaft disposed adjacent to a proximal end of the second accommodating portion; and a proximal end side-covering that covers (i) a part of a proximal end side of the second accommodating portion not covered with the distal end side-covering, (ii) a boundary portion between the second accommodating portion and the shaft, and (iii) a part of a distal end side of the shaft, wherein: a second region has a stiffness equal to or larger than a stiffness of a first region, the first region being a region of the second accommodating portion covered with the distal end side-covering but not covered with the proximal end side-covering, and the second region being a region of the second accommodating portion not covered with the distal end side-covering but covered with the proximal end side-covering.

6. The guide wire according to claim 5, wherein: a third region has a stiffness equal to or larger than the stiffness of the second region, the third region being a region of the shaft covered with the proximal end side-covering.

7. The guide wire according to claim 6, wherein: a fourth region has a stiffness equal to or larger than the stiffness of the third region, the fourth region being a region of the shaft not covered with the proximal end side-covering.

8. The guide wire according to claim 5, wherein: the first accommodating portion, the second accommodating portion, and the proximal end side-covering are formed of a hyperelastic material, and the distal end side-covering and the shaft are formed of a material that is more plastically deformable than the hyperelastic material.

9. The guide wire according to claim 5, wherein: the first accommodating portion and the second accommodating portion are formed of a hyperelastic material, and the distal end side-covering, the proximal end side-covering, and the shaft are formed of a material that is more plastically deformable than the hyperelastic material.

10. The guide wire according to claim 1, wherein the distal end side-covering is a coil body comprising one or more element wires wound spirally.

11. The guide wire according to claim 1, wherein the detection element is configured to detect a pressure of a body fluid flowing through the inside of the vessel.

12. The guide wire according to claim 1, further comprising: a distal end coil disposed adjacent to a distal end of the first accommodating portion, the distal end coil comprising one or more element wires wound spirally.

13. The guide wire according to claim 2, wherein the second accommodating portion comprises, at a distal end side of the second accommodating portion, a diameter-decreasing portion having an outer diameter gradually decreasing from a proximal end side of the second accommodating portion to the distal end side of the second accommodating portion.

14. The guide wire according to claim 13, wherein the proximal end portion of the first accommodating portion comprises a stepped portion that is engaged with the distal end portion of the distal end side-covering.

15. The guide wire according to claim 2, further comprising: a shaft disposed adjacent to a proximal end of the second accommodating portion; and a proximal end side-covering that covers (i) a part of a proximal end side of the second accommodating portion not covered with the distal end side-covering, (ii) a boundary portion between the second accommodating portion and the shaft, and (iii) a part of a distal end side of the shaft, wherein: a second region has a stiffness equal to or larger than a stiffness of a first region, the first region being a region of the second accommodating portion covered with the distal end side-covering but not covered with the proximal end side-covering, and the second region being a region of the second accommodating portion not covered with the distal end side-covering but covered with the proximal end side-covering.

16. The guide wire according to claim 15, wherein: a third region has a stiffness equal to or larger than the stiffness of the second region, the third region being a region of the shaft covered with the proximal end side-covering.

17. The guide wire according to claim 16, wherein: a fourth region has a stiffness equal to or larger than the stiffness of the third region, the fourth region being a region of the shaft not covered with the proximal end side-covering.

18. The guide wire according to claim 15, wherein: the first accommodating portion, the second accommodating portion, and the proximal end side-covering are formed of a hyperelastic material, and the distal end side-covering and the shaft are formed of a material that is more plastically deformable than the hyperelastic material.

19. The guide wire according to claim 15 wherein: the first accommodating portion and the second accommodating portion are formed of a hyperelastic material, and the distal end side-covering, the proximal end side-covering, and the shaft are formed of a material that is more plastically deformable than the hyperelastic material.

20. A guide wire comprising: a sensor comprising: a sensor head configured to detect information about a vessel from inside of the vessel; and a sensor cable extending from the sensor head toward a proximal end side of the guide wire, and that is configured to transmit the detected information; a housing comprising: a first accommodating portion housing the sensor head; and a second accommodating portion housing the sensor cable; and a distal end side-covering that covers the second accommodating portion, wherein a distal end portion of the distal end side-covering is connected to a proximal end portion of the first accommodating portion.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0022] FIG. 1 shows an illustrative diagram of a cross-sectional configuration of a guide wire according to a first aspect of the disclosed embodiments.

[0023] FIG. 2 shows an illustrative diagram of a cross-sectional configuration along the A-A line in FIG. 1.

[0024] FIG. 3 shows an illustrative diagram of the configuration of an intermediate portion.

[0025] FIG. 4 shows an illustrative diagram of the configuration of a proximal end portion.

[0026] FIG. 5 shows an illustrative diagram of the configuration of an intermediate portion of a guide wire according to a second aspect of the disclosed embodiments.

[0027] FIG. 6 shows an illustrative diagram of the configuration of a proximal end portion of the guide wire according to the second aspect of the disclosed embodiments.

[0028] FIG. 7 shows an illustrative diagram of the configuration of an intermediate portion of a guide wire according to a third aspect of the disclosed embodiments.

[0029] FIG. 8 shows an illustrative diagram of the configuration of an intermediate portion of a guide wire according to a fourth aspect of the disclosed embodiments.

[0030] FIG. 9 shows an illustrative diagram of the configuration of a proximal end portion of a guide wire according to a fifth aspect of the disclosed embodiments.

[0031] FIG. 10 shows an illustrative diagram of the configuration of an intermediate portion of a guide wire according to a sixth aspect of the disclosed embodiments.

[0032] FIG. 11 shows an illustrative diagram of a cross-sectional configuration of a guide wire according to a seventh aspect of the disclosed embodiments.

[0033] FIG. 12 shows an illustrative diagram of a cross-sectional configuration of a guide wire according to an eighth aspect of the disclosed embodiments.

[0034] FIG. 13 shows an illustrative diagram of the configuration of the intermediate portion of a guide wire according to a ninth aspect of the disclosed embodiments.

DETAILED DESCRIPTION OF EMBODIMENTS

First Aspect of the Disclosed Embodiments

[0035] FIG. 1 shows an illustrative diagram of a cross-sectional configuration of a guide wire 1 according to a first aspect of the disclosed embodiments. The guide wire 1 according to the present aspect of the disclosed embodiments is a device which is to be inserted into a blood vessel, and can be used to detect blood pressure (intravascular pressure). The blood pressure detected with the guide wire 1 can be used to derive a coronary fractional flow reserve (FFR). The coronary fractional flow reserve, which represents a pressure after a stenotic segment relative to a pressure before the stenotic segment, is used as a measure of the physiological severity of stenosis.

[0036] In FIG. 1, an axis line O (a dot-and-dash line) represents an axis passing through the center of the guide wire 1. The following descriptions assume that the axis passing through the center of the guide wire 1 and an axis passing through the center of each of the members of the guide wire 1 coincide with the axis line O, but they each may be different. It is noted that the XYZ axes intersecting orthogonally to each other are shown in FIG. 1. The X-axis corresponds to the axis direction of the guide wire 1 (the insertion direction of the guide wire 1), and the Y-axis corresponds to the height direction of the guide wire 1, and the Z-axis corresponds the width direction of the guide wire 1. The left side (the X axis direction) in FIG. 1 is referred to a distal end side of the guide wire 1 and constituent members thereof, and the right side (the +X axis direction) in FIG. 1 is referred to as a proximal end side of the guide wire 1 and constituent members thereof. Further, with regard to the guide wire 1 and constituent members thereof, an end portion and the vicinity thereof located at the distal end side is referred to an distal end portion or simply a distal end, and an end portion and the vicinity thereof located at the proximal end side is referred to an proximal end portion or simply a proximal end. The distal end side is to be inserted into the inside of a body, and the proximal end side is to be operated by an operator such as a physician. These also apply to the figures other than FIG. 1.

[0037] As shown in FIG. 1, the guide wire 1 includes a distal end portion 100, an intermediate portion 200, and a proximal end portion 300. The distal end portion 100 is disposed at the distal end side of the guide wire 1, and includes a distal end core 101, a distal end tip 105, and a distal end coil 110.

[0038] The distal end core 101 is a solid member disposed along the axis line O of the guide wire 1 and having an outer diameter decreasing from the proximal end side to the distal end side thereof. The distal end core 101 has a distal end portion 101b disposed at the distal end side thereof, a flange portion 101a disposed at the proximal end side thereof, and a tapered portion 101c disposed between the distal end portion 101b and the flange portion 101a. The distal end portion 101b is a member with a substantially cylindrical shape having a substantially constant outer diameter, and a region from the distal end portion 101b through the middle of the tapered portion 101c has been subjected to an annealing process (annealed). The flange portion 101a is a member with a substantially cylindrical shape having a substantially constant outer diameter larger than that of the distal end portion 101b. The tapered portion 101c is a member having an outer diameter smaller than that of the flange portion 101a at the proximal end side thereof and gradually decreasing from the proximal end side to the distal end side thereof. The distal end core 101 is formed of a hyperelastic material, for example, a NiTi (nickel-titanium) alloy or an alloy of NiTi with an additional metal(s).

[0039] The distal end coil 110 is disposed so as to circumferentially surround the distal end core 101, and has a substantially constant outer diameter from the proximal end side through the distal end side thereof. The distal end coil 110 has a first coil body 102 disposed inside and a second coil body 103 disposed outside. The first coil body 102 is a single-thread coil configured such that a single element wire is twisted to be single-threaded. The second coil body 103 is also a single-thread coil configured such that a single element wire is wound to be single-threaded. It is noted that the first coil body 102 and the second coil body 103 each may be a single-thread coil configured such that a single element wire is wound to be single-threaded, or may be a multi-thread coil configured such that a plurality of element wires are wound to be multi-threaded, or may be a single-thread twisted wire coil configured such that a twisted wire in which a plurality of element wires are twisted is wound to be single-threaded, or may be a multi-thread twisted wire coil configured such that a plurality of twisted wires in which a plurality of element wires are twisted are each wound to be multi-threaded. It is noted that the first coil body 102 and the second coil body 103 constitute the distal end coil.

[0040] The proximal end portion of the first coil body 102 and the proximal end portion of the second coil body 103 are each joined to the proximal end portion of the tapered portion 101c of the distal end core 101 through a joining region 106. Joining can be achieved by using any joining agent, for example, a metal solder such as silver solder, gold solder, zinc, an SnAg alloy, and an AuSn alloy; and an adhesive such as an epoxy-based adhesive. In the example as shown in FIG. 1, an element wire of the second coil body 103 has a larger wire diameter than an element wire of the first coil body 102. However, they may have the substantially same wire diameter, or the element wire of the second coil body 103 may have a smaller wire diameter than the element wire of the first coil body 102. The first coil body 102 and the second coil body 103 may be formed of, for example, a material more plastically deformable than a hyperelastic material, for example, a stainless steel alloy such as SUS304 and SUS316.

[0041] The distal end tip 105 is disposed at the distal end portion 100 of the guide wire 1, and joins and holds the distal end portion of the distal end core 101, the distal end portion of the first coil body 102, and the distal end portion of the second coil body 103 together. The distal end tip 105 can be formed of any joining agent, for example, a metal solder such as silver solder, gold solder, zinc, an SnAg alloy, and an AuSn alloy; and an adhesive such as an epoxy-based adhesive.

[0042] FIG. 2 shows an illustrative diagram of a cross-sectional configuration along the A-A line in FIG. 1. FIG. 3 shows an illustrative diagram of the configuration of the intermediate portion 200. As shown in FIGS. 1 and 3, the intermediate portion 200 is disposed between the distal end portion 100 and the proximal end portion 300 of the guide wire 1, and includes a sensor 201, an accommodating portion 202, a hollow twisted wire 203, and a covering layer 204.

[0043] The sensor 201 is an optical pressure sensor for detecting the pressure of a body fluid flowing through the inside of a blood vessel, and is disposed on the proximal end side of the distal end core 101 along the axis line O of the guide wire 1. The sensor 201 has a sensor head 201a disposed at the distal end portion thereof and a sensor cable 201b disposed at the proximal end side thereof. The sensor head 201a is a detection element (a microchip) for detecting blood pressure by a Fabry-Perot resonator which performs wavelength modulation of light in response to a change in an external pressure. It is noted that the sensor head 201a may be an optical detection element for detecting blood pressure by a means other than a Fabry-Perot resonator, or may be a non-optical detection element. The sensor cable 201b is an optical fiber for transmitting information detected with the sensor head 201a. The sensor cable 201b has a distal end portion connected to the sensor head 201a, and extends from the sensor head 201a toward the proximal end side of the guide wire 1, and has a proximal end portion connected to a controller (not shown) and a display (not shown). It is noted that the sensor 201 corresponds the detection portion, and the sensor head 201a corresponds to the detection element, and the sensor cable 201b corresponds to the extension portion.

[0044] The accommodating portion 202 is a member for protecting the sensor 201 by accommodating the sensor 201 (the sensor head 201a and the sensor cable 201b) inside. The accommodating portion 202 has a housing portion 202a disposed at the distal end side thereof, a proximal end portion 202c disposed at the proximal end side thereof, and an intermediate portion 202b disposed between the housing portion 202a and the proximal end portion 202c.

[0045] The housing portion 202a is a member with a substantially closed-end cylindrical shape having the substantially same outer diameter as the second coil body 103. The sensor head 201a is housed in an inner space HG of the housing portion 202a. As indicated by broken lines in FIG. 2, through-holes (a first hole 202d and a second hole 202e) allowing communication between the inside and the outside of the housing portion 202a are formed on the side of the housing portion 202a at a part along the direction of the axis line O (the X-axis direction) and a part along the circumferential direction. During use of the guide wire 1, the first hole 202d and the second hole 202e each serve as a blood flow channel which allows blood in a blood vessel to flow into the inner space HG where the sensor head 201a is housed. Further, as shown in FIGS. 1 and 3, a through-hole for insertion of the sensor cable 201b is formed on the bottom of the housing portion 202a. A housing distal end portion 202f having no communication hole is disposed at the distal end of the housing portion 202a. The inner surface of the housing distal end portion 202f is joined to the flange portion 101a of the distal end core 101 through a first joining region 109. The first joining region 109 can be formed by laser welding of the housing distal end portion 202f with the flange portion 101a. The first joining region 109 may be formed of any joining agent or adhesive.

[0046] The intermediate portion 202b is a member with a substantially cylindrical shape having a smaller outer diameter than the housing portion 202a. An inner cavity of the intermediate portion 202b is in communication with a through-hole at the bottom of the housing portion 202a, and accommodates the sensor cable 201b. A first tapered portion 202x having an outer diameter decreasing from the proximal end side to the distal end side thereof is disposed at the the distal end side of the intermediate portion 202b. A second tapered portion 202y having an outer diameter increasing from the proximal end side to the distal end side thereof is disposed at the the proximal end side of the intermediate portion 202b. The proximal end portion 202c is a member with a substantially cylindrical shape having a smaller outer diameter than the intermediate portion 202b. An inner cavity of the proximal end portion 202c is in communication with the inner cavity of the intermediate portion 202b, and accommodates the sensor cable 201b. The accommodating portion 202 including the housing portion 202a, the intermediate portion 202b, and the proximal end portion 202c is formed of a hyperelastic material, for example, a NiTi alloy, or an alloy of NiTi with an additional metal(s). It is noted that the accommodating portion 202 corresponds to the housing, the housing portion 202a corresponds to the first accommodating portion, and the intermediate portion 202b and the proximal end portion 202c correspond to the second accommodating portion, and the first tapered portion 202x corresponds to the diameter-decreasing portion.

[0047] The hollow twisted wire 203 is disposed so as to surround the intermediate portion 202b and the proximal end portion 202c in the circumferential direction of the guide wire 1, and covers the intermediate portion 202b, the proximal end portion 202c, and the distal end portion of a shaft 302. As shown in the lower panel of FIG. 3, the hollow twisted wire 203 in the present aspect of the disclosed embodiments is a multi-thread coil configured such that a plurality of element wires 203s are wound to be multi-threaded. The hollow twisted wire 203 may be a single-thread coil configured such that a single element wire is wound to be single-threaded, or may be a single-thread twisted wire coil configured such that a twisted wire in which a plurality of twisted element wires are twisted is wound to be single-threaded, or may be a multi-thread twisted wire coil configured such that a plurality of twisted wires in which a plurality of element wires are twisted are each wound to be multi-thread. The intermediate portion 202b, the proximal end portion 202c, and the distal end portion of the shaft 302 are accommodated in an inner cavity 203h of the hollow twisted wire 203. The distal end portion of the hollow twisted wire 203 is connected (joined) to the proximal end portion of the housing portion 202a through a second joining region 209. The second joining region 209 can be formed of any joining agent, for example, a metal solder such as silver solder, gold solder, zinc, an SnAg alloy, and an AuSn alloy; and an adhesive such as an epoxy-based adhesive. It is noted that the hollow twisted wire 203 corresponds to the distal end side-covering.

[0048] The hollow twisted wire 203 has the substantially same outer diameter at least at the distal end portion thereof (the maximum diameter of the outside of an element wire) as the proximal end portion of the housing portion 202a, and the hollow twisted wire 203 is preferably arranged side by side in the direction of the axis line O so as to be substantially coaxial with the housing portion 202a. In the examples as shown in FIGS. 1 and 3, the hollow twisted wire 203 has the same outer diameter as the proximal end portion of the housing portion 202a throughout the entire region from the distal end side through the proximal end side thereof, and the hollow twisted wire 203 and the housing portion 202a are arranged side by side in the direction of the axis line O so as to be centered with respect with the axis line O. The hollow twisted wire 203 is formed of, for example, a material more plastically deformable than a hyperelastic material, for example, a stainless steel alloy such as SUS304 and SUS316.

[0049] The covering layer 204 is a hydrophilic coating layer covering the hollow twisted wire 203. In the example as shown in FIG. 1, the covering layer 204 covers each of the hollow twisted wire 203, the second joining region 209 disposed at the distal end portion of the hollow twisted wire 203, and a third joining region 309a disposed at the proximal end portion of the hollow twisted wire 203. The covering layer 204 can be formed of, for example, a hydrophilic resin such as urethane, polyimide, and nylon.

[0050] FIG. 4 shows an illustrative diagram of the configuration of the proximal portion 300. As shown in FIGS. 1 and 4, the proximal end portion 300 is disposed at the proximal end side of the guide wire 1, and includes a hollow shaft 301, the shaft 302, and a proximal end side-covering layer 304.

[0051] As shown in FIG. 1, the hollow shaft 301 is a member for protecting the sensor cable 201b by accommodating the sensor cable 201b inside. The hollow shaft 301 has a distal end portion 301a disposed at the distal end side thereof, and a proximal end portion 301b continuing to the proximal end side.

[0052] The distal end portion 301a is a member with a substantially cylindrical shape having the substantially same bending stiffness as the proximal end portion 202c of the accommodating portion 202. As shown in FIG. 4, the hollow shaft 301 is connected to the shaft 302, and the shaft 302 is connected to the accommodating portion 202. That is, the hollow shaft 301 is connected to the accommodating portion 202 through the shaft 302. Connection between the hollow shaft 301 and the shaft 302, and between the shaft 302 and the accommodating portion 202 can be achieved by using any joining agent, for example, a metal solder such as silver solder, gold solder, zinc, an SnAg alloy, and an AuSn alloy, and an adhesive such as an epoxy-based adhesive. In FIG. 4, the distal end portion of the distal end portion 301a and the proximal end portion of the proximal end portion 202c of the accommodating portion 202 are not connected to each other, but they may be connected. Hereinafter, the boundary portion between the distal end portion of the distal end portion 301a and the proximal end portion of the proximal end portion 202c may also be referred to as a boundary portion BP (FIG. 4). An inner cavity of the distal end portion 301a is in communication with the inner cavity of the proximal end portion 202c of the accommodating portion 202, and houses the sensor cable 201b. A tapered portion 301x having an outer diameter decreasing gradually from the proximal end side to the distal end side thereof is formed at the proximal end side of the distal end portion 301a.

[0053] The proximal end portion 301b is a member with a substantially cylindrical shape having the substantially same outer diameter as the shaft 302. An inner cavity of the proximal end portion 301b is in communication with the inner cavity of the distal end portion 301a, and houses the sensor cable 201b. The hollow shaft 301 including the distal end portion 301a, the tapered portion 301x, and the proximal end portion 301b is formed of a material more plastically deformable than a hyperelastic material, for example, a stainless steel alloy such as SUS304 and SUS316. It is noted that the hollow shaft 301 corresponds to the shaft.

[0054] As shown in FIG. 4, the shaft 302 is a member covering the vicinity of the boundary portion BP between the accommodating portion 202 and the hollow shaft 301 to protect the boundary portion BP, and also enabling the stiffness of the guide wire 1 to be gradually changed. Specifically, the shaft 302 covers a part of the proximal end side of the accommodating portion 202 not covered with the hollow twisted wire 203 (that is, the proximal end portion 202c), the boundary portion BP between the accommodating portion 202 and the hollow shaft 301, and a small-diameter part of the distal end side of the hollow shaft 301 (that is, the distal end portion 301a). The shaft 302 has a tapered portion 302x formed at the distal end side thereof, and a proximal end portion 302a formed at the proximal end side thereof. The proximal end portion 302a is a member with a substantially cylindrical shape having the substantially same outer diameter as the proximal end portion 301b of the hollow shaft 301, and having a smaller inner diameter than the hollow twisted wire 203.

[0055] The tapered portion 302x is a portion having an outer diameter decreasing from the proximal end side to the distal end side thereof. As shown in FIG. 4, a part of the distal end side of the tapered portion 302x enters into the inside of the hollow twisted wire 203. The outer surface of the tapered portion 302x is joined to the proximal end portion of the hollow twisted wire 203 through the third joining region 309a. The inner surface of the proximal end portion 302a and the tapered portion 302x is joined to the outer surface of the proximal end portion 202c of the accommodating portion 202 through a fourth joining region 309b. Further, the proximal end portion 302a of the shaft 302 is joined to the tapered portion 301x of the hollow shaft 301 through a fifth joining region 309c. The third and fourth joining regions 309a and 309b can be formed of any joining agent, for example, a metal solder such as silver solder, gold solder, zinc, an SnAg alloy, and an AuSn alloy; and an adhesive such as an epoxy-based adhesive. The third joining region 309a can be formed by laser welding of the hollow shaft 301 with the shaft 302. The third joining region 309a may be formed of any joining agent or adhesive. The shaft 302 including the tapered portion 302x and the proximal end portion 302a is formed of a material more plastically deformable than a hyperelastic material, for example, a stainless steel alloy such as SUS304 and SUS316. It is noted that the shaft 302 corresponds to the proximal end side-covering portion.

[0056] Here, as shown in FIG. 4, a region where the accommodating portion 202 is covered with the hollow twisted wire 203, but not covered with the shaft 302 is referred to as a first region A1. Similarly, a region where the accommodating portion 202 is covered with the shaft 302, but not covered with the hollow twisted wire 203 is referred to as a second region A2. A region where the hollow shaft 301 is covered with the shaft 302 is referred to as a third region A3. A region where the hollow shaft 301 is not covered with the shaft 302 is referred to as a fourth region A4. Here, the stiffness of the second region A2 is equal to or larger than that of the first region A1. Further, the stiffness of the third region A3 is equal to or larger than that of the second region A2. Moreover, the stiffness of the fourth region A4 is equal to or larger than that of the third region A3. That is, the first to fourth regions have a stiffness gradually increasing from the distal end side toward the proximal end side thereof (stiffness: A1A2A3A4). The difference in stiffness as described above is achieved by the different diameters of the accommodating portion 202 between the first and second regions A1 and A2, the different materials of the accommodating portion 202 and the hollow shaft 301 between the second and third regions A2 and A3, the different diameters of the shaft 302 between the second and third regions A2 and A3, and the different diameters of the hollow shaft 301 between the third and fourth regions A3 and A4.

[0057] The proximal end side-covering layer 304 is a fluorine-based resin coating layer covering an area from the fifth joining region 309c through the proximal end portion of the hollow shaft 301. The proximal end side-covering layer 304 can be formed of a fluorine-based resin, for example, polytetrafluoroethylene (PTFE), perfluoroalkoxyethylene (PFA). fluorinated ethylene propylene (FEP), and the like.

[0058] In general, as shown in FIG. 1, the sensor cable 201b (the extension portion) for transmitting information detected with the sensor head 201a (the detection element) for detecting information about a vessel such as a blood vessel has a smaller diameter than the sensor head 201a. The guide wire 1 according to the first aspect of the disclosed embodiments includes the hollow twisted wire 203 (the covering portion) further covering the intermediate portion 202b and the proximal end portion 202c (the second accommodating portion) of the accommodating portion 202 accommodating the sensor cable 201b having a small diameter. In this configuration, the hollow twisted wire 203 can prevent scattering of the guide wire 1, and can also prevent a scattered piece from remaining in the body even if a breakage occurs at the intermediate portion 202b and the proximal end portion 202c of the accommodating portion 202. Further, the distal end portion of the above hollow twisted wire 203 is connected to the proximal end portion of the housing portion 202a (the first accommodating portion) of the accommodating portion 202 accommodating the sensor head 201a. This configuration can prevent scattering of the guide wire 1 at the boundary between the housing portion 202a and the intermediate portion 202b, and can also prevent a scattered piece from remaining in the body. Furthermore, the configuration where the distal end portion of the hollow twisted wire 203 is connected to the proximal end portion of the housing portion 202a can improve the torquability when the guide wire 1 is rotationally operated. These features of the guide wire 1 according to the first aspect of the disclosed embodiments can reduce the risk of scattering for the the guide wire 1 capable of obtaining information about a vessel (blood pressure and coronary fractional flow reserve in the case of the first aspect of the disclosed embodiments) in the inside of the vessel.

[0059] Further, as shown in FIG. 1, the distal end portion of the hollow twisted wire 203 (the covering portion) has the substantially same outer diameter as the proximal end portion of the housing portion 202a (the first accommodating portion), and the hollow twisted wire 203 is arranged side by side (side by side in the direction of the axis line O) so as to be substantially coaxial with the housing portion 202a (centered with respect to the axis line O). This configuration can allow an outer surface shape L (FIG. 3) at the connecting portion section between the distal end portion of the hollow twisted wire 203 and the proximal end portion of the housing portion 202a to be shaped to be flat without unevenness, preventing damages to tissues inside a blood vessel (a vessel).

[0060] Moreover, the configuration where the first tapered portion 202x (the diameter decreasing portion) having an outer diameter gradually decreasing from a proximal end side to the distal end side thereof is formed at the distal end portion of the intermediate portion 202b (the second accommodating portion) of the accommodating portion 202 as shown in FIG. 3 can allow the distal end portion of the intermediate portion 202b to be more flexible as compared with the proximal end side of the intermediate portion 202b.

[0061] Furthermore, as shown in FIG. 4, the stiffness of the region (the second region A2) of the intermediate portion 202b and the proximal end portion 202c (the second accommodating portion) of the accommodating portion 202 covered with the shaft 302 (the proximal end side-covering portion) but not covered with the hollow twisted wire 203 (the covering portion) is equal to or larger than the stiffness of the region (the first region A1) of the intermediate portion 202b and the proximal end portion 202c of the accommodating portion 202 covered with the hollow twisted wire 203 but not covered with with the shaft 302. Further, the stiffness of the region (the third region A3) of the hollow shaft 301 (the shaft portion) covered with the shaft 302 is equal to or larger than that of the second region A2. Moreover, the stiffness of the region (the fourth region A4) of the hollow shaft 301 (the shaft portion) not covered with the shaft 302 is equal to or larger than that of the third region A3. The above configuration enables the stiffness of the guide wire to be gradually decreased from the proximal end side to the distal end side thereof, and can provide a guide wire excellent in supporting capability, torquability, and vascular selectivity. Furthermore, the configuration where the shaft 302 covers the boundary portion BP between the accommodating portion 202 and the hollow shaft 301 and the both ends thereof (that is, a part of the proximal end side of the accommodating portion 202 not covered with the hollow twisted wire 203, and a part of the distal end side of the hollow shaft 301) can prevent occurrence of a breakage and/or a kink at the boundary portion BP between the accommodating portion 202 and the hollow shaft 301, improving the durability of the guide wire 1.

[0062] Further, the fracture durability at the housing portion 202a (the first accommodating portion) and the intermediate portion 202b and the proximal end portion 202c of the accommodating portion 202 (the second accommodating portion) can be improved, for example, by using a hyperelastic material having high fatigue strength such as a NiTi alloy and an alloy of NiTi with an additional metal(s). Moreover, when a material more plastically deformable than a hyperelastic material, for example, a stainless steel alloy such as SUS304 and SUS316 is used for the hollow twisted wire 203 (the covering portion), the shaft 302 (the proximal end side-covering portion), and the hollow shaft 301 (the shaft portion), the guide wire 1 can have a stiffness gradually decreasing from the proximal end side to the distal end side thereof, thereby providing the guide wire 1 excellent in supporting capability, torquability, and vascular selectivity.

[0063] Moreover, in the configuration where the shaft 302 (the covering portion) is a coil body configured such that one or more element wires are wound spirally, breakage at both the shaft 302 and the intermediate portion 202b and the proximal end portion 202c (the second accommodating portion) of the accommodating portion 202, if it occurs, would merely cause the element wire(s) of the shaft 302 to unwind and extend. This can further prevent scattering of the guide wire, and can further prevent a scattered piece from remaining in the body.

[0064] Furthermore, in the configuration where the sensor head 201a (the detection element) is for detecting the pressure of a body fluid flowing through the inside of a vessel such as a blood vessel, the guide wire 1 can serve as a device for detecting (measuring) blood pressure. Further, the presence of the distal end coil 110 disposed on the distal end side of the housing portion 202a (the first accommodating portion) and configured such that one or more element wires are wound spirally can improve the flexibility at the distal end side, and thus can reduce the risk of damage to tissues inside a vessel.

Second Aspect of the Disclosed Embodiments

[0065] FIG. 5 shows an illustrative diagram of the configuration of the intermediate portion 200 of a guide wire 1A according to a second aspect of the disclosed embodiments. The guide wire 1A according to the second aspect of the disclosed embodiments includes an accommodating portion 202A at the intermediate portion 200 in place of the accommodating portion 202. For the accommodating portion 202A, a stepped portion 202n for engaging with the distal end portion of the hollow twisted wire 203 is formed at the proximal end portion of the housing portion 202a. The stepped portion 202n is a notch formed at the bottom corner of the housing portion 202a, and extends in the circumferential direction of the guide wire 1A. The hollow twisted wire 203 is joined to the second joining region 209 in a state where the distal end portion of the hollow twisted wire 203 is in engagement with the stepped portion 202n of the accommodating portion 202A.

[0066] FIG. 6 shows an illustrative diagram of the configuration of the proximal portion 300 of the guide wire 1A according to the second aspect of the disclosed embodiments. The guide wire 1A according to the second aspect of the disclosed embodiments includes a shaft 302A at the proximal end portion 300 in place of the shaft 302. The shaft 302A is formed of a material different from the first aspect of the disclosed embodiments, specifically, formed of a hyperelastic material, for example, a NiTi alloy or an alloy of NiTi with an additional metal(s). Here, as shown in FIG. 6, a region where the accommodating portion 202A is covered with the hollow twisted wire 203, but not covered with the shaft 302A is referred to as a first region A11. Similarly, a region where the accommodating portion 202A is covered with the shaft 302A, but not covered with the hollow twisted wire 203 is referred to as a second region A21. A region where the hollow shaft 301 is covered with the shaft 302A is referred to as a third region A31. A region where the hollow shaft 301 is not covered with the shaft 302A is referred to as a fourth region A41. Here, the stiffness of the second region A21 is equal to or larger than that of the first region A11 as in the first aspect of the disclosed embodiments. The stiffness of the third region A31 is equal to or larger than that of the second region A21. The stiffness of the fourth region A41 is equal to or larger than that of the third region A31. (stiffness: A11A21A31A41).

[0067] The shape of the housing portion 202a of the accommodating portion 202A may optionally be changed as described above. For example, the stepped portion 202n for engaging with the hollow twisted wire 203 may be formed. Alternatively, the housing portion 202a may be configured, for example, to have a shape other than the substantially closed-end cylindrical shape (for example, a spherical shape having an inner space HG and a through-hole serving as a blood flow channel). Further, the material of the shaft 302A may optionally be changed. For example, the aforementioned hyperelastic materials or resin materials may be used. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments. Moreover, the configuration of the guide wire 1A according to the second aspect of the disclosed embodiments where the stepped portion 202n engaging with the distal end portion of the hollow twisted wire 203 (the covering portion) is formed at the proximal end portion of the housing portion 202a (the first accommodating portion) enables easy positioning of the housing portion 202a with the hollow twisted wire 203 at the time of manufacture. Moreover, locally increased stiffness can be avoided at the connection section between the housing portion 202a and the hollow twisted wire 203 (that is, a portion in which the second joining region 209 is disposed) as compared with the configuration described in the first aspect of the disclosed embodiments where the stepped portion 202n is not disposed.

[0068] Further, the guide wire 1A according to the second aspect of the disclosed embodiments where the shaft 302A (the proximal end side-covering portion) is made of a hyperelastic material enables the stiffness to be gradually changed over the first to fourth regions A11 to A41. Moreover, the fracture durability at the housing portion 202a (the first accommodating portion) and the intermediate portion 202b and the proximal end portion 202c (the second accommodating portion) of the accommodating portion 202A can be improved, for example, by using a hyperelastic material having high fatigue strength such as a NiTi alloy and an alloy of NiTi with an additional metal(s). Furthermore, use of a material more plastically deformable than a hyperelastic material, for example, a stainless steel alloy such as SUS304 and SUS316 for the hollow twisted wire 203 (the covering portion) and the hollow shaft 301 (the shaft portion) enables the stiffness of the guide wire 1A to be gradually decreased from the proximal end side to the distal end side thereof, thereby providing the guide wire 1A excellent in supporting capability, torquability, and vascular selectivity.

Third Aspect of the Disclosed Embodiments

[0069] FIG. 7 shows an illustrative diagram of the configuration of the intermediate portion 200 of a guide wire 1B according to a third aspect of the disclosed embodiments. The guide wire 1B according to the third aspect of the disclosed embodiments includes an accommodating portion 202B at the intermediate portion 200 in place of the accommodating portion 202. The housing portion 202a of the accommodating portion 202B has an outer diameter smaller than that of the hollow twisted wire 203. This creates a step (white arrow heads in FIG. 7) at an outer surface shape L of the guide wire in the connection section between the distal end portion of the hollow twisted wire 203 and the proximal end portion of the housing portion 202a of the guide wire 1B. As described above, the outer diameter of each constituent member of the guide wire 1B (for example, the distal end coil 110, the accommodating portion 202B, the hollow twisted wire 203, the hollow shaft 301, and the shaft 302) can optionally be changed. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments.

Fourth Aspect of the Disclosed Embodiments

[0070] FIG. 8 shows an illustrative diagram of the configuration of the intermediate portion 200 of a guide wire 1C according to a fourth aspect of the disclosed embodiments. The guide wire 1C according to the fourth aspect of the disclosed embodiments includes an accommodating portion 202C at the intermediate portion 200 in place of the accommodating portion 202. In the accommodating portion 202C, the diameter-decreasing portion (the first tapered portion 202x in FIG. 3) is not formed at the distal end of the intermediate portion 202b. As described above, the diameter-decreasing portions and the diameter-increasing portions in each constituent member of the guide wire 1C (for example, the first tapered portion 202x and the second tapered portion 202y of the accommodating portion 202C, the tapered portion 101c of the distal end core 101, the tapered portion 302x of the shaft 302, the tapered portion 301x of the hollow shaft 301, and the like) may be omitted. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments.

Fifth Aspect of the Disclosed Embodiments

[0071] FIG. 9 shows an illustrative diagram of the configuration of the proximal portion 300 of a guide wire 1D according to a fifth aspect of the disclosed embodiments. In the proximal end portion 300, the guide wire 1D according to the fifth aspect of the disclosed embodiments includes neither the shaft 302 (FIG. 4) nor the fifth joining region 309c (FIG. 4), but includes a hollow shaft 301D in place of the hollow shaft 301. The hollow shaft 301D has the substantially same outer diameter as the hollow twisted wire 203, and has a distal end portion 301a in which a stepped portion for fitting the proximal end portion 202c of the accommodating portion 202 at the internal surface thereof, and the proximal end portion 301b continuously extending to the proximal end side of the distal end portion 301a. The proximal end portion 202c of the accommodating portion 202 in a state where it is fitted into the stepped portion of the distal end portion 301a is joined through the fourth joining region 309b and the boundary portion BP.

[0072] Here, as shown in FIG. 9, a region where the accommodating portion 202 is covered with the hollow twisted wire 203 is referred to as a fifth region A5. Further, a region where the accommodating portion 202 is covered with the hollow shaft 301D is referred to as a sixth region A6. Moreover, a region where the accommodating portion 202 is not covered with the hollow shaft 301D is referred to as a seventh region A7. Here, the stiffness of the sixth region is equal to or larger than that of the fifth region. The stiffness of the seventh region is equal to or larger than that of the sixth region (stiffness: A5A6A7). Such difference in stiffness is brought by the difference in diameters of the accommodating portion 202 over the fifth to seventh regions A5 to A7 and the difference in inner diameters of the hollow shaft 301D.

[0073] As described above, the configuration of the proximal end portion 300 can optionally be changed. For example, the shaft 302 may be omitted, or a plurality of shafts 302 may be included, or the configuration of the hollow shaft 301D may be changed. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments.

Sixth Aspect of the Disclosed Embodiments

[0074] FIG. 10 shows an illustrative diagram of the configuration of the intermediate portion 200 of a guide wire 1E according to a sixth aspect of the disclosed embodiments. The guide wire 1E according to the sixth aspect of the disclosed embodiments includes an accommodating portion 202E at the intermediate portion 200 in place of the accommodating portion 202. In the accommodating portion 202E, a plurality of sets (3 sets in the example of the figure) of the first holes 202d and the second holes 202e are formed at the housing portion 202a. As described above, the shape of the housing portion 202a of the accommodating portion 202A can optionally be changed. For example, a plurality of sets of the first holes 202d and the second holes 202e may be formed. Further, for example, either one of the first hole 202d and the second hole 202e may be omitted to have a configuration where a single through-hole is formed, or the housing portion 202a may be configured to be a porous body. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments. Further, the guide wire 1E according to the sixth aspect of the disclosed embodiments can promote an easier flow of intravascular blood into the inner space HG where the sensor head 201a is housed.

Seventh Aspect of the Disclosed Embodiments

[0075] FIG. 11 shows an illustrative diagram of a cross-sectional configuration of a guide wire 1F according to a seventh aspect of the disclosed embodiments. The guide wire 1F according to the seventh aspect of the disclosed embodiments does not include the distal end coil 110 (FIG. 1), but includes a distal end core 101F at the distal end portion 100 in place of the distal end core 101. In the distal end core 101F, the tapered portion 101c (FIG. 1) is not disposed at the distal end portion of the flange portion 101a, but the distal end portion 101b is directly disposed. Further, the proximal end portion of the distal end tip 105 is joined to the housing distal end portion 202f of the accommodating portion 202. As described above, the configuration of the distal end portion 100 can optionally be changed. For example, the distal end coil 110 may be omitted, or the shape of the distal end core 101F may be changed, or the distal end tip 105 may be omitted. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments.

Eighth Aspect of the Disclosed Embodiments

[0076] FIG. 12 shows an illustrative diagram of a cross-sectional configuration of a guide wire 1G according to an eighth aspect of the disclosed embodiments. The guide wire 1G according to the eighth aspect of the disclosed embodiments includes a distal end coil 110G at the distal end portion 100 in place of the distal end coil 110. The distal end coil 110G includes a first tubular body 102G of a substantially cylindrical tube in place of the first coil body 102 (FIG. 1) as a coil body. The first tubular body 102G may be formed of a similar material as the first coil body 102, or may be formed of a resin material. As described above, the configuration of the distal end portion 100 can optionally be changed. For example, at least one of the first coil body 102 and the second coil body 103 (FIG. 1) may be configured as a tubular body, or at least one of the first coil body 102 and the second coil body 103 may be omitted. These configurations can also produce similar effects as in the first aspect of the disclosed embodiments.

Ninth Aspect of the Disclosed Embodiments

[0077] FIG. 13 shows an illustrative diagram of the configuration of the intermediate portion 200 of a guide wire 111 according to a ninth aspect of the disclosed embodiments. The guide wire 111 according to the ninth aspect of the disclosed embodiments includes an accommodating portion 202H at the intermediate portion 200 in place of the accommodating portion 202. The accommodating portion 202H include a housing portion 202aH in which a tapered portion 202z and a stepped portion 202m are formed. The tapered portion 202z has an inclination formed at the bottom of the housing portion 202aH, and has an outer diameter gradually increasing from the proximal end side to the distal end side thereof. The stepped portion 202m corresponds to a notch formed at the tapered portion 202z. In the example as shown in FIG. 13, the hollow twisted wire 203 is joined through a second joining region 209H in a state where the distal end portion thereof is engaged with the stepped portion 202m.

[0078] As described above, the shape of the housing portion 202aH can optionally be changed. The tapered portion 202z having an outer diameter gradually increasing from the proximal end side to the distal end side thereof may be disposed at the proximal end portion of the housing portion 202aH. This configuration can also produce similar effects as in the first aspect of the disclosed embodiments. Further, the configuration according to the ninth aspect of the disclosed embodiments where the tapered portion 202z is disposed at the proximal end portion of the housing portion 202aH can relieve a stress concentration occurring between the housing portion 202aH and the first tapered portion 202x. This in turn can improve fatigue strength of the accommodating portion 202H, improving durability against fracture due to bending and twisting.

Variations of Disclosed Embodiments

[0079] The present invention shall not be limited to the above embodiments, but can be implemented according to various aspects without departing from the scope and spirit of the present invention. For example, the following variations may be possible.

Variation 1

[0080] In the above first to ninth aspects of the disclosed embodiments, the configurations of the guide wires 1, and 1A to 1H are exemplified. However, various changes may be made in the configuration of the guide wire 1. For example, each of the guide wires according to the above aspects of the disclosed embodiments is described as a device which can be inserted into a blood vessel and used to detect blood pressure. However, the guide wire 1 may be configured as a device which can be inserted into a vessel such as the vascular system and the lymph gland system, and used to detect/obtain information (temperature, pressure, an image, and the like) about the vessel. Further, the guide wire 1 may be configured as a device which can be inserted into an organ in the human body such as the vascular system, the lymph gland system, the biliary tract system, the urinary tract system, the respiratory tract system, the digestive organ system, secretory glands, reproductive organs, and the like, and used to detect/obtain information (temperature, pressure, an image, and the like) about a body lumen.

Variation 2

[0081] In the above first to ninth aspects of the disclosed embodiments, the configurations of the intermediate portions 200 are exemplified. However, various changes may be made in the configurations of the intermediate portions 200. For example, the hollow twisted wire 203 may be configured as a substantially cylindrical tube (a tubular body) instead of a coil body. For example, at least one of the outer diameter and the inner diameter of the hollow twisted wire 203 may not necessarily be constant. For example, the proximal end portion of the hollow twisted wire 203 may be connected to the distal end portion of the hollow shaft 301. In this case, the shaft 302 may be omitted, or the shaft 302 may be arranged inside the hollow twisted wire 203 (which corresponds to a configuration where the shaft 302 is covered with the hollow twisted wire 203). For example, the covering layer 204 may be omitted, or the covering layer 204 may be configured so as to cover each portion of the distal end portion 100. For example, at least one of the accommodating portion 202 and the hollow twisted wire 203 may be formed of a material (for example, a resin material) other than those listed above.

Variation 3

[0082] In the above first to ninth aspects of the disclosed embodiments, the configurations of the proximal portions 300 are exemplified. However, various changes may be made in the configurations of the intermediate portions 300. For example, the hollow shaft 301 and the shaft 302 may be formed integrally. For example, the hollow shaft 301 may be composed of a core shaft and a coil body covering the core shaft. For example, the hollow shaft 301 and the shaft 302 may be omitted, and the accommodating portion 202 and the hollow twisted wire 203 may extend to the proximal end portion of the guide wire 1. For example, the stiffness of the first regions A1 and A11, the second regions A2 and A21, the third regions A3 and A31, and the fourth regions A4 and A41 may not necessarily follow the relationship of stiffness of A1A2A3A4 and A11A21A31A41.

[0083] For example, the proximal end side-covering layer 304 may be omitted, or the proximal end side-covering layer 304 and the covering layer 204 may be formed integrally. For example, the proximal end side-covering layer 304 and the covering layer 204 may be formed in layers (stacked in the circumferential direction of the guide wire 1). For example, at least one of the hollow shaft 301 and the shaft 302 may be formed of a material (for example, a resin material) other than those listed above.

Variation 4

[0084] The configurations of the guide wires 1 and 1A to 1H according to the first to ninth aspects of the disclosed embodiments, and the configurations of the guide wires 1 and 1A to 1H according to the variations 1 to 3 may be combined in an appropriate manner. For example, the configurations of the distal end portions 100 described in any of the ninth and eighth aspects of the disclosed embodiments, the configurations of the intermediate portions 200 described in the second, third, fourth, sixth, and ninth aspects of the disclosed embodiments, and the configurations of the proximal end portions 300 described in the second and fifth aspects of the disclosed embodiments can each be combined in any fashion.

[0085] As described above, the present aspect is described based on the aspects of the disclosed embodiments and variations, but the aforementioned modes of implementing the aspect are provided merely for better understanding of the present aspect, and shall not be construed as limiting the present aspect. Alternations and improvements may be made in the present aspect without departing from the scope and spirit of the claims, and equivalents thereof fall within the scope of the present aspect. Moreover, a technical feature may be omitted, if desired, unless otherwise stated as essential in the present specification.