JP2016182213A - Sensor-attached guide wire - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a sensor-attached guide wire which has good operability and is excellent in joint strength between housings located on both sides of a sensor holder holding a pressure sensor and wires joined with each of the housings so as not to cause positional deviation in a radial direction.SOLUTION: A sensor-attached guide wire includes a pressure sensor 50, a sensor holder 30 having cylindrical housings 31, 32, and a first wire 10 and a second wire 20 which are joined with the housings 31, 32 respectively. The tip parts of a first core wire 11 and a first inside coil 12 are inserted into the inside of the housing 31. The housing 31 and the first wire 10 are joined with each other while the top surface of a first outside coil 13 abuts to the base end surface of the housing 31. The base end parts of a second core wire 21 and a second inside coil 22 are inserted into the inside of the housing 32. The housing 32 and the second wire 20 are joined with each other while the base end surface of a second outside coil 23 abuts to the tip surface of the housing 32.SELECTED DRAWING: Figure 1

Description

  The present invention relates to a sensor-equipped guide wire having a pressure sensor at a distal end portion.

  Conventionally, as a means for measuring the coronary artery pressure on the proximal side and the distal side of the stenosis in order to calculate the fractional flow reserve ratio (Fractional Flow Reserve) that is an index of necessity of PCI treatment, A sensor-equipped guide wire having a pressure sensor in its part is used.

As such a guide wire with a sensor, the following Patent Document 1 introduces a sensor / guide wire assembly as shown in FIG.
The sensor guide wire assembly 1 includes a hollow tube 2, a first coil 4 attached to the tip of the hollow rod 2, and a jacket 6 (short tube) joined to the tip of the first coil 4. The second coil 5 joined to the tip of the jacket 6, the tip 7 joined to the tip of the second coil 5, and the rear end portion thereof are disposed in the hollow cage 2, and the first coil 4 and A core wire 3 inserted into the inside of the jacket 6, the tip portion extending to the tip side of the jacket 6 and inserted into the second coil 5, and a sensor element attached to the core wire 3 located in the jacket 6 8 and an electric wire 9 for connecting the sensor element 8 to an electronic unit (not shown). The sensor element 8 located in the jacket 6 comes into contact with the blood surrounding the tip of the sensor guide wire assembly 1 through the opening 10 formed in the jacket 6.

Japanese Patent No. 4819040 (FIG. 1)

  However, the sensor-equipped guidewire (sensor / guidewire assembly) described in Patent Document 1 has the following problems.

(1) As shown in FIG. 5, the wire portion on the proximal end side of the first coil 4 is constituted by a hollow tube 2 in order to insert the electric wire 9 of the sensor element 8.
However, compared with a solid wire, the hollow tube has low rigidity such as bending rigidity, and the guide wire constituted by the hollow tube 2 is easily bent and inferior in pushing characteristics.
The guide wire constituted by the hollow tube 2 is easily bent when it is inserted through the blood vessel, and the guide wire with the bent flange is greatly reduced in torque transmission.
As described above, the sensor-equipped guide wire described in Patent Document 1 is inferior in operability as a guide wire because most of the guide wire is constituted by the hollow tube 2.

(2) The first coil 4 and the jacket 6 are in contact with the former distal end surface and the latter proximal end surface. However, since the contact area is small, the first coil 4 and the jacket 6 are disposed between the first coil 4 and the jacket 6. The bonding strength (connection strength) is low.
The second coil 5 and the jacket 6 are in contact with the former proximal end surface and the latter distal end surface, but since the contact area is small, the junction between the second coil 5 and the jacket 6 is performed. The force (connection strength) is also low.

(3) At the time of manufacturing the sensor-equipped guidewire described in Patent Document 1, it is difficult to join the jacket 6 and the first coil 4 in a state where the center axes thereof are exactly matched with each other. It is easy to cause displacement in the radial direction between the jacket 6 and the first coil 4.
In addition, it is difficult to join the jacket 6 and the second coil 5 in a state where the center axes of the jacket 6 and the second coil 5 are exactly aligned with each other, and the positional deviation in the radial direction between the jacket 6 and the second coil 5 is difficult. Easy to wake up.

  And the guide wire with a sensor which caused the position shift of radial direction between the jacket 6 and the 1st coil 4 and / or between the jacket 6 and the 2nd coil 5 transmits torque as a guide wire. It is extremely inferior.

  Further, when such a radial displacement occurs, a step is formed on the outer periphery of the joint between the first coil 4 and the jacket 6 and / or the joint between the jacket 6 and the second coil 5. Is formed. This step becomes an obstacle when introducing a medical instrument such as a catheter, and the medical instrument cannot be smoothly introduced along the sensor-equipped guide wire.

  It is possible to increase the diameter of the core wire 3 to the same extent as the inner diameter of the jacket 6 so as not to cause such a radial displacement. However, the sensor-equipped guide wire obtained in this way is flexible. It becomes inferior to.

The present invention has been made based on the above situation.
It is an object of the present invention to have a high operability and a high bonding strength between a housing on both sides of a sensor holder holding a pressure sensor and a wire bonded to each of the housings. An object of the present invention is to provide a sensor-equipped guide wire that does not cause displacement.

The sensor-equipped guidewire of the present invention is a sensor-equipped guidewire comprising a pressure sensor at the tip portion,
A pressure sensor capable of wireless communication;
A sensor holder having a cylindrical housing of the same shape on the proximal end side and the distal end side of the sensor holding portion;
A first wire having a double coil structure joined to the proximal housing;
A second wire having a double coil structure joined to the housing on the distal end side,
The first wire is a solid first core wire;
The first core wire has an inner diameter that is the same as or slightly larger than the diameter of the tip of the first core wire, and an outer diameter that is the same as or slightly smaller than the inner diameter of the housing, and covers the outer periphery of the tip of the first core wire. A first inner coil attached to the tip of one core wire;
The first inner coil having an inner diameter that is the same as or slightly larger than the outer diameter of the first inner coil, and an outer diameter that is substantially the same as the outer diameter of the housing, excluding the tip of the first inner coil A first outer coil attached to the tip of the first core wire so as to cover the outer periphery of the first core wire,
The second wire is a solid second core wire;
An inner diameter that is the same as or slightly larger than the diameter of the second core wire and an outer diameter that is the same as or slightly smaller than the inner diameter of the housing, and is attached to the second core wire so as to cover the outer periphery of the second core wire. A second inner coil,
The second inner side having an inner diameter that is the same as or slightly larger than the outer diameter of the second inner coil, and an outer diameter that is substantially the same as the outer diameter of the housing, excluding the base end of the second inner coil A second outer coil attached to the second core wire so as to cover the outer periphery of the coil,
The distal end portion of the first core wire and the distal end portion of the first inner coil are inserted into the housing on the proximal end side of the sensor holder, and on the proximal end surface of the housing on the proximal end side of the sensor holder. With the front end surface of the first outer coil being in contact, the housing and the first wire are joined,
A proximal end portion of the second core wire and a proximal end portion of the second inner coil are inserted into the housing on the distal end side of the sensor holder, and on the distal end surface of the housing on the distal end side of the sensor holder. The housing and the second wire are joined in a state where the base end surface of the second outer coil is in contact.

  According to the sensor-equipped guide wire having such a configuration, since the pressure sensor capable of wireless communication is provided, the lead wire of the pressure sensor and a space for inserting the pressure sensor are unnecessary, and the first core wire is solid. This wire can be used, and the solid first core wire can exhibit good operability.

  Further, according to the guide wire with a sensor having such a configuration, not only the distal end surface of the first outer coil is in contact with the proximal end surface of the housing on the proximal end side of the sensor holder, but also the first inner coil inside the housing. Since the housing and the first wire (the first core wire, the first inner coil, and the first outer coil) are joined in a state where the distal end portion of the one core wire and the distal end portion of the first inner coil are inserted, both The bonding strength (the connection strength between the sensor holder and the first wire) is sufficiently high.

  Furthermore, not only the proximal end surface of the second outer coil is in contact with the distal end surface of the housing on the distal end side of the sensor holder, but also the proximal end portion of the second core wire and the proximal end of the second inner coil are disposed inside the housing. Since the housing and the second wire (the second core wire, the second inner coil, and the second outer coil) are joined in a state where the portion is inserted, the joint strength between the two (the sensor holder and the second wire) The connection strength) is sufficiently high.

Further, according to the sensor-equipped guide wire having such a configuration, the first inner coil is mounted so as to cover the outer periphery of the tip portion of the first core wire, and the first inner coil is covered so as to cover the outer periphery of the first inner coil. By mounting the outer coil, the tip of the first core wire, the first inner coil, and the first outer coil that constitute the first wire have a common central axis.
Further, the distal end portion of the first core wire and the distal end portion of the first inner coil are inserted into the housing on the proximal end side of the sensor holder (the inner portion of the housing is inserted by the distal end portion of the first core wire and the distal end portion of the first inner coil). Since the space is embedded), the central axis of the housing and the common central axis of the first core wire, the first inner coil, and the first outer coil can be matched (so-called centering). There is no radial displacement with the first wire. Further, since the housing and the first outer coil have substantially the same outer diameter, a step may be formed on the outer periphery at the joint between the housing and the first wire (first outer coil). Absent.

Further, the second inner coil is mounted so as to cover the outer periphery of the second core wire, and the second outer coil is mounted so as to cover the outer periphery of the second inner coil, thereby constituting the second wire. The second core wire, the second inner coil, and the second outer coil have a common central axis.
Further, the proximal end portion of the second core wire and the proximal end portion of the second inner coil are inserted into the housing on the distal end side of the sensor holder (by the proximal end portion of the second core wire and the proximal end portion of the second inner coil). Since the inner space of the housing is embedded), the central axis of the housing can coincide with the common central axis of the second core wire, the second inner coil, and the second outer coil (so-called centering). This housing and the second wire do not cause radial displacement. Further, since the housing and the second outer coil have substantially the same outer diameter, a step may be formed on the outer periphery at the joint between the housing and the second wire (second outer coil). Absent.

  In addition, the sensor-equipped guide wire having such a configuration does not cause radial displacement between each of the housings on both sides of the sensor holder and the wires (first wire and second wire). Also excellent.

(2) In the guide wire with a sensor of the present invention, the tip of the first core wire and the diameter of the second core wire are 0.04 to 0.22 mm,
The outer diameter of the first inner coil and the second inner coil is 0.18 to 0.28 mm,
It is preferable that outer diameters of the first outer coil and the second outer coil are 0.30 to 0.36 mm.

(3) The sensor-equipped guidewire of the present invention is preferably used for measurement of coronary artery pressure for obtaining a coronary blood flow reserve ratio.

  The sensor-equipped guide wire of the present invention has good operability with a highly rigid wire (particularly, a solid first core wire), and includes housings on both sides of a sensor holding portion for holding a pressure sensor, The bonding strength between the wires (first wire or second wire) to be bonded to each other is high and the housing and the wire (first wire or second wire) do not cause a positional deviation in the radial direction. .

  Further, the guide wire with sensor of the present invention does not cause radial displacement between each of the housings on both sides of the sensor holder and the wire (first wire or second wire). In addition to being excellent in transmission, no step is formed on the outer periphery of the joint between each of the housings and the wire (first wire or second wire).

It is sectional drawing which shows one Embodiment of the guide wire with a sensor of this invention. It is a schematic diagram for showing the effect of the present invention. It is explanatory drawing which shows the simulation apparatus for testing the torque transmission property of a guide wire with a sensor. It is a graph which shows the torque transmissibility of a guide wire with a sensor. It is sectional drawing which shows the conventional guide wire with a sensor.

Hereinafter, an embodiment of the present invention will be described.
A sensor-equipped guide wire 100 according to the present embodiment shown in FIG. 1 is a sensor-equipped guide wire having a pressure sensor at the tip, and has the same cylindrical housings 31 and 32 as the pressure sensor 50 capable of wireless communication. Sensor holders 30 on both sides of the sensor holding plate 35, a first wire 10 having a double coil structure joined to a housing 31 on the proximal end side, and a double coil structure joined to a housing 32 on the distal end side. The first wire 10 has a solid first core wire 11, an inner diameter that is the same as or slightly larger than the diameter of the tip of the first core wire 11, and the inner diameter of the housing 31. Alternatively, the first inner wire has a slightly smaller outer diameter and is attached to the distal end portion of the first core wire 11 so as to cover the outer periphery of the distal end portion of the first core wire 11. The first inner side excluding the tip of the first inner coil 12, having an inner diameter that is the same as or slightly larger than the outer diameter of the coil 12, the first inner coil 12, and the outer diameter of the housing 31. A first outer coil 13 attached to the tip of the first core wire 11 so as to cover the outer periphery of the coil 12, and the second wire 20 includes a solid second core wire 21 and a second core wire 21. A second inner side that has an inner diameter equal to or slightly larger than the diameter and an outer diameter equal to or slightly smaller than the inner diameter of the housing 32 and is attached to the second core wire 21 so as to cover the outer periphery of the second core wire 21. The second inner coil 22 has an inner diameter that is the same as or slightly larger than the outer diameter of the second inner coil 22, and an outer diameter that is the same as the outer diameter of the housing 32, excluding the proximal end of the second inner coil 22. Inner coil 2 and a second outer coil 23 mounted on the second core wire 21 so as to cover the outer periphery of the first core wire 11 and the first inner coil 12 in the housing 31 of the sensor holder 30. In the state where the distal end surface 131 of the first outer coil 13 is in contact with the proximal end surface 311 of the housing 31 of the sensor holder 30, the housing 31 and the first wire 10 are joined, The proximal end portion of the second core wire 21 and the proximal end portion of the second inner coil 22 are inserted into the housing 32 of the holder 30, and the second outer coil 23 is inserted into the distal end surface 321 of the housing 32 of the sensor holder 30. The housing and the second wire 20 are joined with the base end face 231 being in contact therewith.

The pressure sensor 50 constituting the sensor-equipped guide wire 100 is a small and thin film sensor element (MEMS) that can communicate wirelessly. The pressure sensor 50 is attached to one surface of the sensor holding plate 35 of the sensor holder 30.
Since this pressure sensor 50 is a sensor that can communicate wirelessly, it does not have a conducting wire.

  The sensor holder 30 constituting the sensor-equipped guide wire 100 is located on the sensor holding plate 35 that holds the pressure sensor 50, the housing 31 that is located on the proximal side of the sensor holding plate 35, and the distal side of the sensor holding plate 35. And a housing 32.

  The housings 31 and 32 are integrally formed with the sensor holding plate 35, respectively. The housing 31 has a cylindrical shape that opens on the proximal end side, and the first wire 10 is joined to the housing 31. Further, the housing 32 has a cylindrical shape (the same shape as the housing 31) that opens at the distal end side, and the second wire 20 is joined to the housing 32.

The length of the sensor holder 30 is, for example, 1.5 to 3.5 mm.
The outer diameters of the housings 31 and 32 constituting the sensor holder 30 are, for example, 0.30 to 0.36 mm, and 0.36 mm if a suitable example is shown.
The inner diameters of the housings 31 and 32 are, for example, 0.18 to 0.33 mm, and 0.26 mm as a suitable example.
Although it does not specifically limit as a constituent material of the sensor holder 30, Stainless steel etc. can be illustrated.

  The first wire 10 constituting the sensor-equipped guide wire 100 is disposed at the distal end portion of the first core wire 11 so as to cover the outer periphery of the first core wire 11 and the distal end portion (the distal end side small diameter portion 113) of the first core wire 11. The outer circumference of the first inner coil 12 except the attached first inner coil 12 and the tip of the first inner coil 12 (for example, the portion corresponding to 5 pitches from the tip shown in FIG. 1) is covered. The first outer coil 13 is attached to the distal end portion (the distal end side small diameter portion 113 and the intermediate diameter portion 112) of the first core wire 11.

The first core wire 11 that constitutes the first wire 10 includes a proximal-side large-diameter portion 111, an intermediate-diameter portion 112, and a distal-end-side small-diameter portion 113.
The length of the 1st core wire 11 shall be 1720-1970 mm, for example.
The diameter of the base end side large-diameter portion 111 of the first core wire 11 is 0.30 to 0.36 mm, and is 0.36 mm if a suitable example is shown. The length of the base end side large-diameter portion 111 is 1420 to 1960 mm.
The diameter of the middle diameter portion 112 of the first core wire 11 is 0.15 to 0.26 mm, and is 0.23 mm if a suitable example is shown. The length of the medium diameter portion 112 is 10 to 300 mm.
The diameter of the distal end side small diameter portion 113 of the first core wire 11 is 0.04 to 0.22 mm, and is 0.08 mm if a suitable example is shown. The length of the distal end side small diameter portion 113 is 5 to 200 mm.
The shape of the first core wire 11 is not limited to these.

The first core wire 11 is a solid wire, unlike a hollow tube that constitutes a conventional guide wire with a sensor, because it is not necessary to secure a space for inserting the lead wire of the pressure sensor. As a result, the sensor-equipped guidewire 100 constituted by the first core wire 11 has good operability equivalent to that of a normal guidewire (guidewire constituted by a solid wire).
Here, solid means that the interior is clogged and there is substantially no space (innocent).

Although it does not specifically limit as a constituent material of the 1st core wire 11, Although metals, such as stainless steel (for example, SUS316, SUS304), gold | metal | money, platinum, aluminum, tungsten, tantalum, or these alloys, can be mentioned, this book In the embodiment, it is made of stainless steel.
A water repellent resin layer may be formed on the outer peripheral surface of the first core wire 11.
As the resin constituting the water-repellent resin layer, any resin that is used for medical purposes and has water repellency can be used, and suitable resins include fluorine-based resins such as PTFE.

  The first inner coil 12 constituting the first wire 10 is attached to the distal end portion of the first core wire 11 so as to cover the outer periphery of the distal end portion (the distal end side small diameter portion 113) of the first core wire 11.

  The first inner coil 12 has an inner diameter that is the same as or slightly larger than the diameter of the distal end portion (the distal-side small diameter portion 113) of the first core wire 11 and an outer diameter that is the same as or slightly smaller than the inner diameter of the housing 31.

  Here, the inner diameter of the first inner coil 12 that is “slightly larger” than the diameter of the tip portion (tip-side small diameter portion 113) of the first core wire 11 is, for example, 1.3 of the diameter of the tip portion of the first core wire 11. It is set to not more than twice, preferably not more than 1.1 times.

The outer diameter of the first inner coil 12 “slightly smaller” than the inner diameter of the housing 31 is, for example, 0.5 times or more, preferably 0.9 times or more the inner diameter of the housing 31.
When the outer diameter of the first inner coil 12 is too small with respect to the inner diameter of the housing 31, the housing 31 and the first wire 10 may be displaced in the radial direction.

The inner diameter of the first inner coil 12 that satisfies the above conditions is, for example, 0.055 to 0.23 mm, and 0.09 mm if a suitable example is shown.
Moreover, as an outer diameter of the 1st inner side coil 12 which satisfy | fills said conditions, it will be 0.18-0.28 mm, for example, and will be 0.23 mm if a suitable example is shown.

  The material of the wire constituting the first inner coil 12 is not particularly limited, and examples include stainless steel (for example, SUS316, SUS304), Ni—Ti alloy, and the like. The diameter of the wire constituting the first inner coil 12 is 0.03 to 0.06 mm.

  The first outer coil 13 constituting the first wire 10 covers the outer periphery of the first inner coil 12 excluding the distal end portion of the first inner coil 12, and the distal end portion (the distal end side small diameter) of the first core wire 11 is covered. Part 113 and medium diameter part 112).

The tip of the first inner coil 12 inserted in the housing 31 is not covered with the outer periphery by the first outer coil 13.
Here, the length of the distal end portion of the first inner coil 12 varies depending on the length of the housing 31 into which the distal end portion is inserted, for example, 0.1 to 0.8 mm.

  The first outer coil 13 has an inner diameter that is the same as or slightly larger than the outer diameter of the first inner coil 12 and an outer diameter that is the same as the outer diameter of the housing 31.

  Here, the inner diameter of the first outer coil 13 "slightly larger" than the outer diameter of the first inner coil 12 is, for example, 1.3 times or less the outer diameter of the first inner coil 12, and preferably 1. 1 time or less.

The outer diameter of the first outer coil 13 is the same as the outer diameter of the housing 31.
Thereby, when the central axis of the housing 31 and the central axis of the first outer coil 13 are matched, a step is formed on the outer periphery of the joint portion between the housing 31 and the first outer coil 13 (first wire 10). Never formed.

The inner diameter of the first outer coil 13 that satisfies the above conditions is, for example, 0.19 to 0.26 mm, and is 0.24 mm if a suitable example is shown.
Moreover, as an outer diameter of the 1st outer side coil 13 which satisfy | fills said conditions, it is 0.30-0.36 mm, for example, and will be 0.36 mm if a suitable example is shown.

  Although it does not specifically limit as a material of the wire which comprises the 1st outer side coil 13, Stainless steel (for example, SUS316, SUS304), Ni-Ti alloy etc. can be illustrated. The diameter of the wire constituting the first outer coil 13 is 0.05 to 0.07 mm.

The second core wire 21 constituting the second wire 20 is a solid wire having the same diameter over the entire length.
The diameter of the 2nd core wire 21 is the same as the diameter of the small diameter part 113 of the front end side of the 1st core wire 11, and the length of the 2nd core wire 21 shall be 10-50 mm.
Although the constituent material of the 2nd core wire 21 is not specifically limited, The metal similar to the constituent material of the 1st core wire 11 can be mentioned, In this embodiment, it is comprised with stainless steel. A water repellent resin layer may be formed on the outer peripheral surface of the second core wire 21.

  The second inner coil 22 constituting the second wire 20 is attached to the second core wire 21 so as to cover the outer periphery of the second core wire 21.

  The second inner coil 22 has an inner diameter that is the same as or slightly larger than the diameter of the second core wire 21 and an outer diameter that is the same as or slightly smaller than the inner diameter of the housing 32.

  Here, the inner diameter of the second inner coil 22 “slightly larger” than the diameter of the second core wire 21 is, for example, 1.3 times or less, preferably 1.1 times or less, the diameter of the second core wire 21. is there.

In addition, the outer diameter of the second inner coil 22 “slightly smaller” than the inner diameter of the housing 32 is, for example, 0.5 times or more, preferably 0.9 times or more the inner diameter of the housing 32.
When the outer diameter of the second inner coil 22 is too small with respect to the inner diameter of the housing 32, the housing 32 and the second wire 20 may be displaced in the radial direction.

The inner diameter of the second inner coil 22 that satisfies the above conditions is, for example, 0.055 to 0.23 mm, and 0.09 mm if a suitable example is shown.
Moreover, as an outer diameter of the 1st inner side coil 22 which satisfy | fills said conditions, it will be 0.18-0.28 mm, for example, and will be 0.23 mm if a suitable example is shown.

  The material of the wire constituting the second inner coil 22 is not particularly limited, and examples thereof include stainless steel (for example, SUS316, SUS304), Ni—Ti alloy, and the like. The diameter of the wire constituting the second inner coil 22 is 0.03 to 0.06 mm.

  The second outer coil 23 constituting the second wire 20 is attached to the second core wire 21 so as to cover the outer periphery of the second inner coil 22 excluding the base end portion of the second inner coil 22.

  The base end portion of the second inner coil 22 inserted into the housing 32 is not covered with the second outer coil 23.

  Here, the length of the base end portion of the second inner coil 22 varies depending on the length of the housing 32 into which the base end portion is inserted, but is, for example, 0.1 to 0.8 mm.

  The second outer coil 23 has an inner diameter that is the same as or slightly larger than the outer diameter of the second inner coil 22 and an outer diameter that is the same as the outer diameter of the housing 32.

  Here, the inner diameter of the second outer coil 23 that is “slightly larger” than the outer diameter of the second inner coil 22 is, for example, 1.3 times or less the outer diameter of the second inner coil 22, preferably 1. 1 time or less.

The outer diameter of the second outer coil 23 is the same as the outer diameter of the housing 32.
Thereby, when the central axis of the housing 32 and the central axis of the second outer coil 23 are matched, a step is formed on the outer periphery at the joint between the housing 32 and the second outer coil 23 (second wire 20). Never formed.

The inner diameter of the second outer coil 23 that satisfies the above conditions is, for example, 0.19 to 0.26 mm, and is 0.24 mm if a suitable example is shown.
The outer diameter of the second outer coil 23 that satisfies the above conditions is, for example, 0.30 to 0.36 mm, and is 0.36 mm if a suitable example is shown.

  The material of the wire constituting the second outer coil 23 is not particularly limited, but platinum, platinum alloy (for example, Pt / W = 92/8), gold, gold-copper alloy, tungsten, tantalum, etc. Examples thereof include materials (X-ray opaque materials) having good contrast properties for X-rays. The diameter of the wire constituting the second outer coil 23 is 0.05 to 0.07 mm.

  In the guide wire with sensor 100 of the present embodiment, the first inner coil 12 is mounted so as to cover the outer periphery of the distal end portion of the first core wire 11, and the first outer side is covered so as to cover the outer periphery of the first inner coil 12. By attaching the coil 13, the distal end portion of the first core wire 11 constituting the first wire 10, the first inner coil 12, and the first outer coil 13 have a common central axis. Become.

In the guide wire with sensor 100, the distal end portion of the first core wire 11 and the distal end portion of the first inner coil 12 are inserted into the housing 31 of the sensor holder 30, and the proximal end surface 311 of the housing 31 is inserted. The housing 31 and the first wire 10 (the first core wire 11, the first inner coil 12, and the first outer coil 13) are joined by the solder 61 in a state in which the front end surface 131 of the first outer coil 13 is in contact. Has been.
The first outer coil 13 constituting the first wire 10 extends to the proximal end side so as to cover the middle diameter portion 112 of the first core wire 11, and the proximal end portion of the first outer coil 13 is intermediated by the solder 63. It is fixed to the diameter portion 112.

FIG. 2 (1) schematically shows a state in which the distal end portion of the first core wire 11 and the distal end portion of the first inner coil 12 are inserted into the housing 31.
As shown in the figure, the first core wire 11 (113) and the distal end portion of the first inner coil 12 are inserted into the housing 31 together with the distal end portion of the first core wire 11 (113). As a result of the tip of the first inner coil 12 being embedded in the gap between the tip of the core wire 11 and the housing 31, the central axis of the housing 31, the tip of the first core wire 11, the first inner coil 12, and the first outer The common central axis of the coil 13 (not shown in FIG. 2A) can be matched (so-called centering). Thereby, it is possible to prevent a positional displacement in the radial direction between the housing 31 and the first wire 10 (the first core wire 11, the first inner coil 12, and the first outer coil 13).

  When only the distal end portion of the first core wire 11 is inserted without inserting the distal end portion of the first inner coil 12 into the housing 31, the central axis of the housing 31 and the distal end portion of the first core wire 11 are inserted. When it becomes difficult to match the center axis, and the center axis of the housing 31 and the center axis of the tip of the first core wire 11 do not match as shown in FIG. A positional deviation in the radial direction occurs with respect to one wire 10.

  Instead of the first inner coil 12, a sleeve having an outer diameter that is the same as or slightly smaller than the inner diameter of the housing 31 is disposed between the first core wire 11 and the first outer coil 13. When the tip of the sleeve is inserted into the housing 31 together with the tip of the first core wire 11, a sufficient amount of solder is filled between the inner periphery of the housing 31 and the outer periphery of the sleeve. Therefore, the bonding force between the housing 31 and the first wire cannot be secured sufficiently. Moreover, when a sleeve is arranged between the first core wire 11 and the first outer coil 13 to form the first wire, the obtained guide wire with sensor is inferior in flexibility.

  On the other hand, in the sensor-equipped guide wire 100, the second inner coil 22 is mounted so as to cover the outer periphery of the second core wire 21, and the first outer coil 23 is mounted so as to cover the outer periphery of the second inner coil 22. Thus, the second core wire 21, the second inner coil 22, and the second outer coil 23 constituting the second wire 20 have a common central axis.

In the sensor-equipped guide wire 100, the proximal end portion of the second core wire 21 and the proximal end portion of the second inner coil 22 are inserted into the housing 32 of the sensor holder 30, and the distal end surface of the housing 32 is inserted. The housing 32 and the second wire 10 (the second core wire 21, the second inner coil 22, and the second outer coil 23) are connected to the solder 62 in a state where the base end surface 231 of the second outer coil 23 is in contact with the 321. Are joined by.
The second core wire 21, the second inner coil 22, and the second outer coil 23 that constitute the second wire 20 are fixed to each other at the tip by solder 64 to form a tip 25.

  When the second inner coil 22 is inserted into the housing 32 together with the base end portion of the second core wire 21, the central axis of the housing 32, the second core wire 21, the second inner coil 22, and the second outer coil 23 are inserted. Can coincide with the common central axis (so-called centering). Thereby, it is possible to prevent a positional displacement in the radial direction between the housing 32 and the second wire 20 (the second core wire 21, the second inner coil 22, and the second outer coil 23).

  When only the proximal end portion of the second core wire 21 is inserted without inserting the second inner coil 22 into the housing 32, the central axis of the housing 32 and the central axis of the second core wire 21 are made to coincide. When the center axis of the housing 32 and the center axis of the second core wire 21 do not coincide with each other, a radial position shift occurs between the housing 32 and the second wire 20.

  In place of the second inner coil 22, a sleeve having an outer diameter that is the same as or slightly smaller than the inner diameter of the housing 32 is disposed between the second core wire 21 and the second outer coil 23. When the base end portion of the sleeve is inserted into the housing 32 together with the base end portion of the second core wire 21, a sufficient amount of solder is provided between the inner periphery of the housing 32 and the outer periphery of the sleeve. Therefore, the bonding force between the housing 32 and the second wire cannot be secured sufficiently. Further, when the second wire is configured by arranging a sleeve between the second core wire 21 and the second outer coil 23, the obtained guide wire with sensor is inferior in flexibility.

  According to the guide wire with sensor 100 of the present embodiment, since the pressure sensor 50 capable of wireless communication is provided, the lead wire of the pressure sensor 50 and a space for inserting the pressure sensor 50 are not necessary. A solid wire can be used, and good operability with the solid first core wire 10 can be exhibited.

  Further, according to the guide wire with sensor 100 of the present embodiment, not only the distal end surface 131 of the first outer coil 13 is in contact with the proximal end surface 311 of the housing 31 of the sensor holder 30 but also inside the housing 31. With the distal end portion of the first core wire 11 and the distal end portion of the first inner coil 12 inserted, the housing 31 and the first wire 10 (the first core wire 11, the first inner coil 12, and the first outer coil 13) are connected. Since they are bonded, the bonding strength between them (the connection strength between the sensor holder 30 and the first wire 10) is sufficiently high.

  Further, not only the proximal end surface 231 of the second outer coil 23 is in contact with the distal end surface 321 of the housing 32 of the sensor holder 30, but also the proximal end portion of the second core wire 21 and the second inner end of the second outer coil 23 are disposed inside the housing 32. Since the housing 32 and the second wire 20 (the second core wire 21, the second inner coil 22, and the second outer coil 23) are joined in a state in which the proximal end portion of the coil 22 is inserted, the joint strength between the two is obtained. (The connection strength between the sensor holder 30 and the second wire 20) is sufficiently high.

Further, according to the guide wire with sensor 100 of the present embodiment, the first inner coil 12 is mounted so as to cover the outer periphery of the distal end portion of the first core wire 11, and the outer periphery of the first inner coil 12 is covered. Since the first outer coil 13 is mounted, the distal end portion of the first core wire 11 constituting the first wire 10, the first inner coil 12, and the first outer coil 13 have a common central axis. Will have.
Further, by inserting the distal end portion of the first core wire 11 and the distal end portion of the first inner coil 12 into the housing 31 of the sensor holder 30, the central axis of the housing 31, the first core wire 11, and the first inner wire Since the central axis common to the coil 12 and the first outer coil 13 can be made coincident (so-called centering), the housing 31 and the first wire 10 do not cause a positional deviation in the radial direction. Further, since the housing 31 and the first outer coil 13 have the same outer diameter, no step is formed on the outer periphery at the joint between the housing 31 and the first wire 10 (first outer coil 13).

Further, the second inner coil 22 is mounted so as to cover the outer periphery of the second core wire 21, and the second outer coil 23 is mounted so as to cover the outer periphery of the second inner coil 22, thereby The second core wire 21, the second inner coil 22, and the second outer coil 23 constituting the wire 20 have a common central axis.
Further, by inserting the proximal end portion of the second core wire 21 and the proximal end portion of the second inner coil 22 into the housing 32 of the sensor holder 30, the central axis of the housing 32, the second core wire 21, Since the central axis common to the two inner coils 22 and the second outer coil 23 can be made coincident (so-called centering), the housing 32 and the second wire 20 do not cause radial displacement. Further, since the housing 32 and the second outer coil 23 have the same outer diameter, no step is formed on the outer periphery at the joint between the housing 32 and the second wire 20 (second outer coil 23). .

  In the guide wire 100 with sensor according to the present embodiment, each of the housings 31 and 32 on both sides of the sensor holder 30 and the wires (the first wire 10 and the second wire 20) joined thereto are positioned in the radial direction. Since there is no deviation, torque transmission is excellent.

<Example 1>
A sensor holder 30 having cylindrical housings 31 and 32 on both sides of the sensor holding plate 35 is prepared, and the first core wire 11 and the first inner coil 12 are mounted on the proximal end side housing 31 constituting the sensor holder 30. The first wire 10 having a double coil structure including the first outer coil 13 and the first outer coil 13 are joined by soldering, and the second core wire 21 and the second inner coil 22 are connected to the housing 32 on the distal end side constituting the sensor holder 30. The second wire 20 having a double coil structure provided with the second outer coil 23 is joined by soldering, and a pressure sensor 50 made of a thin film sensor element is attached to one surface of the sensor holding plate 35, whereby FIG. The sensor-equipped guide wire of the present invention as shown in FIG.
The details of the components of this sensor-equipped guidewire are shown below.

(1) Pressure sensor 50:
・ Miniature wireless sensor (MEMS)

(2) Sensor holder 30:
・ Material: Stainless steel ・ Length: About 3mm
・ Length of sensor holding plate 35: about 2 mm
・ Length of housings 31 and 32: about 0.4 mm
・ Outer diameter of housings 31 and 32: 0.36 mm
・ Inner diameter of housings 31 and 32: 0.26 mm

(3) First core wire 11:
-Material: Stainless steel-Total length: 1870 mm
-Base end side large diameter part 111: 0.36 mm in diameter
Medium diameter part 112: Diameter 0.23 mm, length 150 mm
・ Side end small diameter part 113: Diameter 0.08mm, length 30mm

(4) First inner coil 12:
-Material: Stainless steel-Total length: 30 mm
-Length of the tip portion inserted into the housing 31: 0.4 mm
-Coil inner diameter: 0.09 mm (1.1 times the diameter of the tip side small diameter portion 113)
-Coil outer diameter: 0.23 mm (0.9 times the inner diameter of the housing 31)
・ Coil wire diameter: 0.07mm

(5) First outer coil 13:
-Material: Stainless steel-Total length: 180 mm
-Coil inner diameter: 0.24 mm (1.1 times the coil outer diameter of the first inner coil 12)
-Coil outer diameter: 0.36 mm (same as outer diameter of housing 31)
・ Coil wire diameter: 0.06mm

(6) Second core wire 21:
-Material: Stainless steel-Total length: 30 mm
・ Diameter: 0.08mm

(7) Second inner coil 22:
-Material: Stainless steel-Total length: 30 mm
-Length of the base end portion inserted into the housing 32: 0.4 mm
-Coil inner diameter: 0.09 mm (1.1 times the diameter of the second core wire 21)
-Coil outer diameter: 0.23 mm (0.9 times the inner diameter of the housing 32)
・ Coil wire diameter: 0.07mm

(8) Second outer coil 23:
・ Material: Platinum alloy (X-ray opaque material)
・ Total length: 30mm
-Coil inner diameter: 0.24 mm (1.1 times the coil outer diameter of the second inner coil 22)
-Coil outer diameter: 0.36 mm (same as outer diameter of housing 32)
・ Coil wire diameter: 0.06mm

<Comparative Example 1>
A first wire is produced without mounting the first inner coil 12 between the first core wire 11 and the first outer coil 13, and the second inner coil 12 is inserted between the second core wire 21 and the second outer coil 23. A comparative sensor-equipped guide wire was produced in the same manner as in Example 1 except that the second wire was produced without mounting.

<Evaluation (torque transmission)>
Each of the sensor-equipped guidewires obtained in Example 1 and Comparative Example 1 was inserted into a jig simulating the human coronary artery shown in FIG. 3, and the proximal end (hand side) of the guidewire was The tip was rotated by a motor at a predetermined hand side angle of 0 to 360 °, and the tip rotation angle (twist angle) at the distal end (tip) of the guide wire was examined. The results are shown in FIG. The closer to the theoretical line shown in FIG. 4, the better the torque transmission and the better the operability. When the torque transmission is good, the rotational force on the proximal side is easily transmitted to the tip, and it becomes easy to advance to the target blood vessel by selecting the blood vessel branch, and the insertion workability is improved.

  From the results shown in FIG. 4, the sensor-equipped guide wire obtained in Example 1 has a small delay in the rotation operation on the distal end side with respect to the rotation operation on the proximal end side, and has excellent torque transmission. . On the other hand, the guide wire obtained in Comparative Example 1 had a large delay in rotational operation on the distal end side and was inferior in torque transmission.

10 First wire 11 First core wire 111 Proximal end large diameter portion 112 Medium diameter portion 113 Distal end small diameter portion (distal end portion)
12 First inner coil 13 First outer coil 131 First outer coil tip surface 20 Second wire 21 Second core wire 22 Second inner coil 23 Second outer coil 231 Second outer coil proximal end surface 25 Tip tip 30 Sensor holder 31 Housing (base end side)
311 Base end surface 32 of housing Housing (front end side)
321 Housing front end surface 35 Sensor holding plate 50 Pressure sensor 61-64 Solder

Claims (3)

A guide wire with a sensor provided with a pressure sensor at the tip,
A pressure sensor capable of wireless communication;
A sensor holder having a cylindrical housing of the same shape on the proximal end side and the distal end side of the sensor holding portion;
A first wire having a double coil structure joined to the proximal housing;
A second wire having a double coil structure joined to the housing on the distal end side,
The first wire is a solid first core wire;
The first core wire has an inner diameter that is the same as or slightly larger than the diameter of the tip of the first core wire, and an outer diameter that is the same as or slightly smaller than the inner diameter of the housing, and covers the outer periphery of the tip of the first core wire. A first inner coil attached to the tip of one core wire;
The first inner coil having an inner diameter that is the same as or slightly larger than the outer diameter of the first inner coil, and an outer diameter that is substantially the same as the outer diameter of the housing, excluding the tip of the first inner coil A first outer coil attached to the tip of the first core wire so as to cover the outer periphery of the first core wire,
The second wire is a solid second core wire;
An inner diameter that is the same as or slightly larger than the diameter of the second core wire and an outer diameter that is the same as or slightly smaller than the inner diameter of the housing, and is attached to the second core wire so as to cover the outer periphery of the second core wire. A second inner coil,
The second inner side having an inner diameter that is the same as or slightly larger than the outer diameter of the second inner coil, and an outer diameter that is substantially the same as the outer diameter of the housing, excluding the base end of the second inner coil A second outer coil attached to the second core wire so as to cover the outer periphery of the coil,
The distal end portion of the first core wire and the distal end portion of the first inner coil are inserted into the housing on the proximal end side of the sensor holder, and on the proximal end surface of the housing on the proximal end side of the sensor holder. With the front end surface of the first outer coil being in contact, the housing and the first wire are joined,
A proximal end portion of the second core wire and a proximal end portion of the second inner coil are inserted into the housing on the distal end side of the sensor holder, and on the distal end surface of the housing on the distal end side of the sensor holder. A guide wire with a sensor, wherein the housing and the second wire are joined in a state in which a base end surface of the second outer coil is in contact. The tip of the first core wire and the diameter of the second core wire are 0.04 to 0.22 mm,
The outer diameter of the first inner coil and the second inner coil is 0.18 to 0.28 mm,
The guide wire with a sensor according to claim 1, wherein outer diameters of the first outer coil and the second outer coil are 0.30 to 0.36 mm.   The sensor-equipped guide wire according to claim 1 or 2, which is used for measuring coronary artery pressure to obtain a coronary flow reserve ratio.

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