Torca

Abstract

To provide a torquer that can measure the operating status of a guide wire more easily and accurately. [Solution] The torquer comprises a holding component (12), an operating component (30), a substrate (40), and a plurality of strain gauges (50) for measuring the strain of a guide wire (500). The holding component (12) fixes the guide wire (500) along the insertion path through which the guide wire (500) is inserted. The operating component (30) is connected to the holding component (12) and operates the guide wire (500). The substrate (40) is a strain generating body and is connected to the operating component (30). The plurality of strain gauges (50) are located on the substrate (40).

Description

Technical Field

[0001] This invention relates to a torquer.

Background Art

[0002] In a catheter system, a guide wire for guiding the insertion of a catheter is inserted and rotated by a torquer on the proximal end side. In order to more safely and easily insert this guide wire, Patent Document 1 discloses a sensing system that is located on the torquer and includes a sensor for measuring the tip position, orientation, and contact pressure of the guide wire, and a sensor for measuring the torque, feed amount, and rotation amount of the guide wire in the driver on the proximal end side.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, in the conventional technology, the structure and control are complex, and it is not easy to incorporate and operate in a torquer.

[0005] An object of this invention is to provide a torquer that can more easily and accurately measure the operating conditions of a guide wire.

Means for Solving the Problems

[0006] To achieve the above object, this invention provides a holding component that fixes the guide wire along an insertion path through which the guide wire is inserted, an operating component that is connected to the holding component and operates the guide wire, a substrate that is a strain body and is connected to the operating component, A plurality of strain gauges located on the substrate for measuring the strain of the guide wire, It is a torquer equipped with [the necessary features]. [Effects of the Invention]

[0007] According to the present invention, the operating status of the guide wire can be measured more easily and accurately. [Brief explanation of the drawing]

[0008] [Figure 1] This is an external perspective view of the Torker. [Figure 2] These are a bottom view and a cross-sectional view of the torquer, looking at the base end. [Figure 3] This is a diagram explaining strain gauges. [Figure 4] This figure shows an example of strain gauge placement on a circuit board. [Figure 5] These are a bottom view and a cross-sectional view illustrating a torquer of another embodiment. [Figure 6] These are a bottom view and a cross-sectional view illustrating a torquer of another embodiment. [Modes for carrying out the invention]

[0009] Hereinafter, embodiments of the present invention will be described based on the drawings. Figure 1 is an external perspective view of the torquer 100 of this embodiment. The Torker 100 is used to hold the guide wire 500 and control its movement. The Torker 100 has a substantially cylindrical shape around a central axis L along the insertion path of the guide wire 500. Here, the X-axis is defined along the central axis L. The plane perpendicular to the central axis L is the YZ plane. The Y and Z directions will be described later. Note that the XYZ directions are not related to the orientation during use. That is, the user may operate the Torker 100 in any orientation.

[0010] The guidewire 500 is inserted along the central axis L of the torquer 100, with the +X side facing the tip. The guidewire 500 is extended outward from the opening 10a located at the +X end of the torquer 100 in response to the operation of the torquer 100, and is inserted to a desired location such as a blood vessel of the subject.

[0011] Figure 2 shows a bottom view and a cross-sectional view of the Torker 100 as seen from the base end. The cross-sectional view shown in Figure 2(b) shows the cross-section AA, i.e., the XZ section, which passes through the central axis in the bottom view shown in Figure 2(a). The Torker 100 includes a holding part 10 that fixes and holds the base end (-X side) of the guide wire 500, which is the side closest to the user, and an operating part 30 for operating the guide wire 500.

[0012] The holding part 10 includes a center maintenance part 11 and a holding part 12. The holding part 12 has a cylindrical shape with a through hole along the central axis L, and may be, for example, substantially cylindrical. The through hole is an insertion path through which the guide wire 500 is inserted. The holding part 12 can fix the guide wire 500 in accordance with the operation of the operating part 30, and in the fixed state, it can rotate integrally with the guide wire 500. The holding part 12 may also be able to move the guide wire 500 relative to it, particularly in the X direction, i.e., feed it out toward the tip and retract it from the tip side. The through hole of the holding part 12 is at least partially the same size as the diameter of the guide wire 500, but may have a portion that is thicker than the diameter of the guide wire 500. For example, the through hole of the holding part 12 may have a tapered shape at the tip (+X side). The through hole of the holding part 12 may have a stepped diameter at the base end side (-X side) opposite to the tip.

[0013] The center maintaining component 11 has a hollow shape with a through hole 11a along the X-axis. By holding the holding component 12 in the through hole 11a, the position of the holding component 12 in the YZ plane is defined. The +X side tip position of the holding component 12 is on the -X side of the +X side tip position of the center maintaining component 11 and does not protrude from the opening 10a to the +X side. The center maintaining component 11 can tightly constrict the holding part 10 in the radial direction. By the tightening operation of the center maintaining component 11, the guide wire 500 is fixed to the holding component 12. When the tightening is loosened, the guide wire 500 can move relative to the holding component 12.

[0014] The operating component 30 is a substantially cylindrical member located on the proximal end side of the guide wire 500 relative to the holding part 10. The operating component 30 can be held by the user and receive operations of inserting, pulling out, and rotating the guide wire 500. The operating component 30 has a substrate holding component 31 and a cover member 32.

[0015] The substrate holding component 31 is the main body part of the operating component 30, is connected to the holding component 12, and operates integrally with the holding component 12. Therefore, the substrate holding component 31 can rotate around the central axis L together with the holding component 12 and the guide wire 500. The substrate holding component 31 has a cylindrical shape with a through hole 30a along the central axis L, for example, a substantially cylindrical shape. The +X side tip position of the substrate holding component 31 is where the proximal end portion of the guide wire 500 fixed to the holding component 12 passes through the through hole 30a. The substrate holding component 31 has a notch 31a located on the +Z side and a hole 31b connecting between the through hole 30a and the notch 31a. The notch 31a may be formed by cutting the cylindrical substrate holding component 31 parallel to the through hole 30a and extending in the X direction. The notch 31a may be open on the proximal end side (-X side) of the substrate holding component 31. These notch 31a and hole 31b form a gap portion of the operating component 30.

[0016] A substrate 40 is located on the -Z side bottom surface of the notch 31a. That is, the substrate 40 may be located along the XY plane. The substrate 40 floats above the hole 31b, separated from other members. The substrate 40 may be longer in the X direction and shorter in the Y direction than the planar size of the hole 31b viewed from the +Z side. If the width of the substrate 40 in the Y direction is wider than the width of the hole 31b in the Y direction, the notch 31a may have a two-stage recess structure located in the center, lower than both ends and on the -Z side. Therefore, the substrate 40 is supported and fixed at both ends in the X direction by the substrate holding component 31, forming a plate-like portion (bridged structure) connecting the two ends in a bridge-like manner. The substrate 40 may be fixed to the substrate holding component 31 with an adhesive. The adhesive has high rigidity in the fixed state. An example of this adhesive is a silicone-based adhesive. The substrate 40 does not flex in this state and, in particular, has sufficient strength to prevent relative movement of a non-negligible magnitude relative to the substrate holding component 31 in response to movement and vibration during use. The strength can be obtained by appropriately determining the material and thickness of the substrate 40 for the required length and width. For example, the length of the substrate 40 may be 10 to 100 mm, the width 3 to 30 mm, and the thickness 0.025 to 2.0 mm.

[0017] On the substrate 40, a plurality of strain gauges 50 and connection wirings respectively connected to the strain gauges 50 are located. A connector 60 (connection terminal) may be located on the substrate 40. The strain gauge 50 measures the strain of the substrate 40, thereby measuring the strain of the guide wire 500, that is, the load applied to the tip of the guide wire 500. The strain gauge 50 outputs an electrical signal corresponding to the strain. At least the strain gauge 50 is separated from the other members. Each strain gauge 50 may be connected to the connector 60 via a connection wiring. The mounting portions of the strain gauge 50, the connection wiring, and the connector 60 may be directly patterned on the substrate 40. The connector 60 may be near the end portion on the proximal end side (-X side) of the substrate 40, or may be at a position where the substrate 40 is supported by the substrate holding component 31. By connecting an external wiring to the connector 60, the signal related to the strain gauge 50 can be easily drawn out to the outside from the open surface of the through hole 20a. For example, the connection wiring may be soldered and connected to the mounting portion of the connector 60 patterned on the substrate by reflow or the like. The electrical signal drawn out from the external wiring is analyzed by an information processing device or the like, the state of the guide wire 500 is specified, and a notification operation such as appropriate display may be performed based on the specified result. The substrate 40 is an insulating strained body having an appropriate Young's modulus and having a thermal expansion characteristic as close as possible to that of the metal of the strain gauge 50, that is, the thermal expansion coefficient may be low. If the Young's modulus is high, the stress applied to the guide wire 500 is not transmitted to the strain gauge 50. For example, the substrate 40 may have an epoxy resin layer. Alternatively, the substrate 40 may be a glass fiber system, a ceramic system, a silicon wafer, a polyimide, a urethane rubber sheet, glass, or the like. The base portion of the substrate 40 may have a single-layer structure of an epoxy resin layer. Since the substrate 40 has a flat plate shape and the notch 31a is parallel to the central axis L, the substrate 40 is also parallel to the insertion path of the guide wire 500.

[0018] The cover member 32 covers at least the notch 31a of the substrate holding component 31, allowing the user to hold the torquer 100 without touching the substrate 40. The cover member 32 may cover the entire outer circumference of the substrate holding component 31 in a substantially circular shape when viewed from the bottom in the -X direction. The inner surface of the cover member 32 may be shaped to follow the cylindrical outer edge of the substrate holding component 31 in the absence of the notch 31a. Therefore, the cover member 32 is spaced apart from the strain gauge 50 according to the depth of the notch 31a. The cover member 32 may have a surface shape that is easy for the user to hold, or it may be surface-treated. The cover member 32 is made of a material suitable for secure holding by the user, such as polypropylene resin.

[0019] Figure 3 is a diagram illustrating the strain gauge 50. As shown in Figure 3(a), the strain gauge 50 has two electrodes 51 and a strip-shaped resistor 52 located between the electrodes 51, with a thin wire (signal wire) bent in a zigzag pattern. The direction perpendicular to the direction of extension of each thin wire within the plane of the strain gauge 50 is defined as the gauge direction v. The resistance of the resistor 52 changes due to expansion and contraction in response to the stress applied in the direction perpendicular to the gauge direction v, i.e., the direction of extension of the thin wire, and the strain can be calculated from this change in resistance. By determining an appropriate gauge direction v, the desired strain can be measured. The conductor may be, for example, a copper-nichrome alloy, chromium, or chromium nitride.

[0020] As shown in Figure 3(b), strain may be determined using a bridge circuit, such as a Wheatstone bridge. The Wheatstone bridge circuit has resistors R1 to R4. Of these, resistors R1 and / or R2 may be the resistors 52 of the strain gauge 50. The resistors R1 to R4 that are not resistors 52 may be reference fixed resistors. In a strain-free state, the resistance values ​​of resistors R1 to R4 may be the same. The stress is determined by the output voltage e with respect to the input voltage E.

[0021] Figure 3(c) shows an example of the arrangement of strain gauges 50 and connectors 60 on the substrate 40. Here, two strain gauges 50 are positioned, but the number of strain gauges 50 is not limited to this. The ends of the substrate 40, each separated by two dotted lines, are located on the substrate holding component 31, and the portion between the dotted lines does not come into contact with other components such as the substrate holding component 31 or the cover member 32. In other words, the strain gauges 50 are located on the surface (front) of the bridge-like portion of the substrate 40 that does not come into contact with other components, on the side furthest from the central axis L. Note that other components 70, etc., besides the strain gauges 50 and connectors 60 may be located on the substrate 40 as needed.

[0022] As described above, the cover member 32 is held by the user, and its temperature rises due to the user's body heat. In an examination or surgical environment of about 25°C, a temperature rise of about 11-12°C can be expected, as the human body temperature is 36-37°C. When such a temperature change is transmitted to the strain gauge 50, the resistance value changes due to thermal expansion, which becomes noise for strain detection. By ensuring that the part of the substrate 40 that is in contact with the strain gauge 50 does not come into contact with other components, especially the cover member 32 and the substrate holding component 31, heat can be less likely to be transmitted to the strain gauge 50. Furthermore, heat conduction through air is even slower than the indirect heat conduction through the holding component 12, so it can be ignored. In addition, as described above, the notch 31a and the through hole 30a are open on the -X side, so the exchange of air within the notch 31a, hole 31b, and through hole 30a prevents the internal air from rising.

[0023] The change in the resistance of the resistor 52 due to temperature changes depends on the temperature coefficient α of the resistor 52 and the thermal expansion of the strain gauge 50 and the object on which the strain is measured, in this case the substrate 40. The thermal expansion coefficient of the strain gauge 50 is denoted as βg, and the thermal expansion coefficient of the substrate 40 is denoted as βs. The strain ε, given the gauge factor K of the strain gauge 50, is expressed by the following formula (1).

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[0024] Using a Wheatstone bridge circuit where the two gauges are resistors 52, with resistance values ​​R1 and R2 for resistors R1 and R2 respectively, and gauge factors K1 and K2, if the resistors 52 undergo the same temperature change, taking the difference in equation (4) for each strain gauge yields the following equation (5).

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[0025] As is clear from equations (4) and (5), if the temperature change ΔT is small, the change in resistance ΔR corresponding to the temperature change ΔT is small. T It is also small. Furthermore, as mentioned above, if the difference between the thermal expansion coefficient βg of the strain gauge 50 and the thermal expansion coefficient βs of the substrate 40 is small, then the change in resistance ΔR is small compared to the temperature change ΔT. T The difference also becomes smaller. For example, the difference between βs and βg is 0.5 to 150 (×10 -6 If the temperature is less than or equal to / K, it may be judged that βs ≈ βg. By positioning the strain gauge 50 on a substrate 40 made of an appropriate material rather than directly on the operating part 30, both the temperature change ΔT and the difference between the thermal expansion coefficients βg and βs can be reduced. Therefore, this torquer 100 effectively reduces noise due to temperature effects, enabling more accurate strain measurement.

[0026] Figure 4 shows an example of the arrangement of strain gauges 50 on the substrate 40. As shown in Figure 4(a), the gauge directions v of the four strain gauges 50a to 50d may be aligned at a 90-degree difference in the X and Y directions within the XY plane. The alignment of the gauge directions v of strain gauges 50a and 50b along the Y direction allows for the detection of stress in the expansion and contraction direction of the guide wire 500, i.e., compressive and tensile stresses. By using these strain gauges 50a and 50b in combination with strain gauges 50c and 50d, whose gauge direction v is aligned along the X direction, the effects of noise can be detected and the magnitude of the strain corrected.

[0027] As shown in Figure 4(b), the gauge direction v of the strain gauges 50c and 50d may be inclined at 45 degrees with respect to the X and Y directions. With strain gauges 50c and 50d oriented in this way, the rotational strain, i.e., torque, of the guide wire 500 can be detected. The strain gauges 50c and 50d may be combined with a strain gauge 50a whose gauge direction is aligned with the Y direction, and a strain gauge 50b whose gauge direction v is aligned with the X direction, to simultaneously detect the effects of expansion and contraction, rotational strain, and noise.

[0028] In the above example, four strain gauges 50a to 50d oriented in different directions are positioned on the substrate 40, but there may also be multiple strain gauges 50 oriented in the same direction. This improves the sensitivity of strain detection. Furthermore, five or more strain gauges 50 may be positioned on the substrate 40. Also, as shown in Figure 4(c), the substrate holding component 31 may have two notches 31a, with a substrate 40 positioned in each of them. In this case, four strain gauges 50 may be positioned on each substrate 40, for a total of eight.

[0029] Figure 5 is a bottom view and a cross-sectional view illustrating the torquer 100 of another embodiment. The cross-sectional position is the same as in Figure 2. In this embodiment, the Torker 100 has a substrate holding component 31 which has a beam 311. The beam 311 crosses the hole 31b perpendicular to the Y direction, i.e., the extending direction of the substrate 40, and supports the substrate 40 by contacting its bottom surface (the -Z side surface). The beam 311 and the substrate 40 may be bonded and fixed together with the same adhesive used to bond both ends of the substrate 40 to the substrate holding component 31.

[0030] The beam 311 supports the substrate 40 at a position that does not overlap with the strain gauge 50 in a plan view from the Z direction. This reduces the increase in heat transferred from the user to the strain gauge 50 while providing stronger support for the substrate 40. Therefore, stress on the guide wire 500 can be detected by the strain gauge 50 with low noise.

[0031] Figure 6 shows a bottom view and a cross-sectional view illustrating a torquer of another embodiment. The cross-sectional position is the same as in Figure 2. In this embodiment, the torquer 100 has a cover member 32 having a hole 32a. The hole 32a penetrates the cover member 32 and connects the notch 31a to the outside. There may be one or more holes 32a. The hole 32a may or may not overlap with the strain gauge 50 in a plan view from the Z direction. The shape of the hole 32a may be circular in plan view, or it may be another shape. For example, the hole 32a may be an elongated hole or a slit.

[0032] The hole 32a provides an air passage to the outside in addition to the -X side end, thereby promoting airflow. Consequently, heated air is less likely to accumulate in the notch 31a, hole 31b, and through hole 30a, further reducing the temperature rise of the strain gauge 50 due to the user's body temperature. Multiple holes 32a can further promote airflow. Also, even if some of the holes 32a are blocked when the user holds the strain gauge, air can still enter and exit through the remaining holes 32a. The hole 32a does not have to be located in the center of the notch 31a in the Y direction. If the hole 32a is directly above the strain gauge 50, the air above the strain gauge 50 moves easily, but direct exposure to wind may have adverse effects. Therefore, the hole 32a may be located in a position that does not overlap with the strain gauge 50 in a plan view.

[0033] As described above, the Torker 100 of this embodiment comprises a holding component 12, an operating component 30, a substrate 40, and a plurality of strain gauges 50 for measuring the strain of the guide wire 500. The holding component 12 fixes the guide wire 500 along the insertion path through which the guide wire 500 is inserted. The operating component 30 is connected to the holding component 12 and operates the guide wire 500. The substrate 40 is a strain generating body and is connected to the operating component 30. The plurality of strain gauges 50 are located on the substrate 40. Having the strain gauges 50 on the substrate 40 allows for easy introduction of the plurality of strain gauges 50 into the Torker 100. Furthermore, the position of the substrate 40 can be easily adjusted according to the number of strain gauges 50 and the size of the operating component 30, making design and manufacturing easy. Furthermore, while the resistor 52 of the strain gauge 50 is originally a conductor with a small coefficient of thermal expansion, the thermal expansion coefficient of the general insulating operating component 30 tends to differ significantly from that of the resistor 52. By inserting a substrate 40, which can be appropriately selected, the adverse effects of thermal expansion are reduced, and measurement accuracy is improved. This makes it possible for users to understand potential problems during operation of the Torker 100 and operate it more safely, even if they are not empirically familiar with the appropriate operating method of the Torker 100.

[0034] Furthermore, the resistors 52 of multiple strain gauges 50 and the connecting wires that connect the resistors 52 to the outside may be directly patterned on the circuit board 40. Since it is not necessary to run wiring cables or lead wires from each of the multiple strain gauges 50 within the torquer 100, the manufacturing process is simplified, and the possibility of wiring cables or lead wires breaking is reduced.

[0035] Furthermore, the circuit board 40 may have a connector 60 for connecting to external wiring. The above-mentioned connection wiring may be connected to the connector 60. Since the external connection cables can be connected to the connector 60 all at once, it is less likely to interfere with the operation of the torquer 100. Also, since the external connection cables can be easily attached and detached, it is easy to replace the torquer 100 connected to the external detection device.

[0036] Furthermore, the substrate 40 may have an epoxy resin layer. Among resins, it has a relatively low coefficient of thermal expansion, and the difference in coefficient of thermal expansion between it and the resistor 52 is small, so noise corresponding to temperature changes can be reduced.

[0037] The operating component 30 may also include a substrate holding component 31 and a cover member 32. The substrate holding component 31 has a cylindrical shape, is connected to the substrate 40 and the holding component 12, and is positioned along the insertion path of the guide wire 500. The cover member 32 covers at least a plurality of strain gauges 50 on the substrate holding component 31 and is held by the user. The plurality of strain gauges 50 may be spaced apart from the cover member 32. By positioning the substrate 40 on the substrate holding component 31, the strain of the substrate holding component 31, which is linked to the guide wire 500, can be detected with high accuracy. In addition, since the substrate 40 is spaced apart from the cover member 32 held by the user, the transmission of the user's body heat to the substrate 40 and the strain gauges 50 on the substrate 40 is reduced, and measurement noise due to temperature changes can be reduced.

[0038] It should be noted that the present invention is not limited to the embodiments described above, and various modifications are possible. For example, the above describes a configuration in which the substrate 40 is supported at both ends in a bridge-like manner and does not come into contact with other components near the center, and a configuration in which a part of the substrate 40 is supported by the beam 311, but the invention is not limited to these. The entire back surface of the substrate 40 may be in contact with the substrate holding component 31.

[0039] Furthermore, the circuit board 40 does not necessarily have to have a connector 60. Wiring may be soldered directly to the wiring pattern on the circuit board. Also, the connector 60 may be separate for each of the multiple strain gauges 50.

[0040] Furthermore, not all connection wiring on the circuit board 40 is patterned. Some may include wired cables or wires.

[0041] Furthermore, the substrate 40 does not have to be a single layer; it may be a multilayer substrate. Also, the substrate 40 does not have to be a rectangle in plan view extending in the X direction; it may have protruding portions or bent portions in the YZ direction. In this case, the protruding portions or bent portions may have bent or curved surfaces such that the surfaces are parallel to the central axis L. The multiple strain gauges 50 do not have to be arranged in a line in the X direction on the substrate 40. By positioning the multiple strain gauges 50 at different positions in the circumferential direction, particularly asymmetrically with respect to the central axis L, it becomes possible to detect strains that are asymmetrical with respect to the central axis L, such as strains corresponding to bending in the X-axis direction or the Y-axis direction. Also, the multiple strain gauges 50a to 50d may each be located on separate substrates 40.

[0042] Furthermore, the cover member 32 does not have to cover the entire substrate holding component 31 in a circumferential manner. For example, the cover member 32 may be partially located within the area where the notch 31a is covered.

[0043] Furthermore, the specific configurations, processing operations, and procedures shown in the above embodiments can be modified as appropriate without departing from the spirit of the present invention. The scope of the present invention includes the scope of the invention described in the claims and its equivalents. [Explanation of Symbols]

[0044] 10 Holding part 10a opening 11 Center Maintenance Parts 11a Through hole 12 Retaining parts 30 Operating parts 30a through hole 31. Circuit board holding components 31a Notch 31b Hole 311 Beam 32 Cover component 32a hole 33 Retaining parts 33b Groove 331 Connection part 40 circuit boards 50, 50a~50d strain gauges 51 electrode 52 Resistors 60 connectors 70 parts 100 Torca 500 guide wires

Claims

1. A retaining component for fixing the guide wire along the insertion path through which the guide wire is inserted, and an operating component connected to the retaining component for operating the guide wire, A strain-generating body, which is a substrate connected to the operating component, A plurality of strain gauges located on the substrate for measuring the strain of the guide wire, Torque car equipped with a torque converter.

2. Torque car according to claim 1, wherein the resistors of the plurality of strain gauges and connecting wires connecting the resistors to the outside are directly patterned on the substrate.

3. The torquer according to claim 2, wherein the circuit board has connection terminals for connecting to external wiring, and the connection wiring is connected to the connection terminals.

4. The torquer according to claim 1, wherein the substrate has an epoxy resin layer.

5. The operating component comprises a cylindrical main body connected to the substrate and the retaining component and positioned along the insertion path, and a cover member that covers at least the plurality of strain gauges of the main body and is held by the user. The plurality of strain gauges are spaced apart from the cover member. Torque car according to claim 1.

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