Torca

Abstract

To provide a torquer that can stably and accurately measure the operating state of the guide wire during operation. [Solution] The torquer comprises a holding component (12), an operating component (30), 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 plurality of strain gauges (50) are located inside the operating component (30). The operating component (30) has a gap outside the plurality of strain gauges (50).

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 perform the insertion of this guide wire more safely and easily, Patent Document 1 discloses a sensing system that is located on the torquer and includes sensors for measuring the tip position, orientation, and tip contact pressure of the guide wire, and sensors for measuring the torque, the feed amount, and the rotation amount of the guide wire in the proximal end side driver.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] However, the guide wire is operated while the operator holds the handle of the driver. Therefore, the sensor located on the torquer is heated by the heat transmitted from the operator's hand, and there is a problem that the sensor is affected and the measured value is likely to deviate from the correct value.

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

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 connects to the aforementioned holding component to operate the guide wire, Multiple strain gauges for measuring the strain of the guide wire, Equipped with, The plurality of strain gauges are located within the operating component, The operating component has a gap on the outside of the plurality of strain gauges. It's Torca. [Effects of the Invention]

[0007] According to the present invention, the operating state of the guide wire can be measured stably and with greater accuracy during the operation of the torquer. [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. [Figure 7] 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 maintaining 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 for example, it may be a substantially cylindrical shape. 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 according to the operation of the operating part 30, and in the fixed state, it can rotate integrally with the guide wire 500. Further, the holding part 12 may be able to relatively move the guide wire 500 particularly in the X direction, that is, feed it out to the tip side and accommodate it from the tip side. The through-hole of the holding part 12 is at least partly of a size similar to the diameter of the guide wire 500, but it may also have a part 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 increase in diameter on the base end side (-X side) opposite to the tip.

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

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

[0015] The substrate holding component 31 is the main body 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, for example, a substantially cylindrical shape, with a through hole 30a along the central axis L. The tip position on the +X side 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 components. 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 inside the operating component 30, 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 when fixed. Examples of adhesives include synthetic resin adhesives such as epoxy, acrylic, and silicone adhesives, instant adhesives such as cyanoacrylate, and rubber adhesives. The substrate 40 does not flex in this state and 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] Multiple strain gauges 50 and connecting wires connected to each strain gauge 50 are located on the substrate 40. A connector 60 (connecting terminal) may also be located on the substrate 40. The strain gauges 50 measure the strain of the guide wire 500, i.e., the load applied to the tip of the guide wire 500, by measuring the strain of the substrate 40. The strain gauges 50 output an electrical signal corresponding to the strain. At least the strain gauges 50 are separated from the other components mentioned above. Each strain gauge 50 may be connected to the connector 60 via connecting wires. The mounting areas for the strain gauges 50, connecting wires, and connectors 60 may be directly patterned on the substrate 40. The connector 60 may be located near the base end (-X side) of the substrate 40, or at a location where the substrate 40 is supported by a substrate holding component 31. By connecting external wiring to the connector 60, signals related to the strain gauge 50 can be easily drawn out to the outside through the open surface of the through hole 30a. For example, the connecting wiring may be soldered to the mounting area of ​​the connector 60 patterned on the substrate by reflow soldering or the like. The electrical signals drawn out from the external wiring can be analyzed by an information processing device or the like to identify the state of the guide wire 500, and based on the identification result, appropriate notification operations such as display can be performed. The substrate 40 is an insulating strain-generating material with an appropriate Young's modulus and has thermal expansion characteristics as close as possible to the metal of the strain gauge 50, i.e., it may have a low coefficient of thermal expansion. If the Young's modulus is high, the stress applied to the guide wire 500 will not be transmitted to the strain gauge 50. For example, the substrate 40 may have an epoxy resin layer. The base of the substrate 40 may have a single-layer structure of epoxy resin. Alternatively, the substrate 40 may be made of glass fiber, ceramic, silicon wafer, polyimide, urethane rubber sheet, glass, etc. Since the substrate 40 is flat 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] Figure 7 is 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. The torquer 100 may have a retaining part 33 in which the substrate retaining part 31 and the substrate 40 are integrated. The retaining part 33 may have a groove 33b that does not penetrate the torquer 100 radially, i.e., in the Z direction, from the side of the through hole 30a. The position of the retaining part 33 that overlaps with the groove 33b in the Z direction is the connecting part 331. The strain gauge 50 is positioned at a location that overlaps with the connecting part 331 in a plan view from the Z direction. As a result, the strain gauge 50 is in contact with the notch 31a on the +Z side and adjacent to the groove 33b on the -Z side, with the connecting part 331 in between. Therefore, the heat insulation of the strain gauge 50 is improved, heat is less likely to be transferred from the cover member 32, etc., and the temperature rise of the strain gauge 50 due to body temperature is reduced. The groove 33b may also have a portion that extends in the ±Y direction and penetrates the retaining component 33.

[0034] As described above, the Torker 100 of this embodiment comprises a holding component 12, an operating component 30, 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 operates the guide wire 500 in connection with the holding component 12. The plurality of strain gauges 50 are located inside the operating component 30. The operating component 30 has a gap formed by a notch 31a on the outside of the plurality of strain gauges 50. In this way, a layer of air is located between the outer surface of the operating component 30 and the strain gauges 50 due to the gap, so that body heat transmitted when the user holds the operating component 30 is less likely to be transmitted to the strain gauges 50. As a result, temperature changes in the strain gauges 50 are reduced, and measurement noise corresponding to temperature changes is reduced. Therefore, this Torker 100 can measure the operating state of the guide wire 500 more stably and accurately during operation.

[0035] Furthermore, the operating component 30 may include a cylindrical substrate holding component 31 having a plurality of strain gauges 50, and a cover member 32 positioned outside the substrate holding component 31, spaced apart from the strain gauges 50, and held by the user. By having the substrate holding component 31 on which the strain gauges 50 are located and the cover member 32 as separate components, less heat is transferred to the strain gauges 50, thereby reducing the temperature rise of the strain gauges 50.

[0036] Furthermore, the substrate holding component 31 may have a notch 31a in which a part of its cylindrical shape is cut out parallel to the insertion path. Multiple strain gauges 50 may be located on the notch 31a. The cover member 32 may have an inner surface along the outer edge of the cylindrical shape. In this way, since a gap is obtained by the inner substrate holding component 31 having a notch 31a, the size of the operating component 30 does not become unnaturally large, and ease of holding is not reduced.

[0037] Furthermore, the cover member 32 may have a hole 32a that penetrates between the gap and the outside. This allows air to flow more easily through the gap, reducing the temperature rise of the strain gauge 50 from the ambient temperature.

[0038] Furthermore, the above-mentioned gap may be open on the base end side of the Torker 100, opposite to the tip direction of the guide wire 500. By opening the gap to the outside, the air inside the gap can be easily exchanged, which further suppresses the rise in temperature of the strain gauge 50 from the ambient temperature.

[0039] It should be noted that the present invention is not limited to the embodiments described above, and various modifications are possible. For example, the gap does not have to be formed by the notch 31a of the cylindrical substrate holding component 31. Also, the inner surface of the cover member 32 does not have to be circumferentially shaped. The outer shape of the substrate holding component 31 and / or the inner surface of the cover member 32 may have any irregular shape with gaps between them.

[0040] Furthermore, the operating component 30 does not necessarily have to consist of a substrate holding component 31 and a cover member 32 as separate components. The operating component 30 may also have a one-piece shape with a gap between them.

[0041] Furthermore, although the base end surface of the torquer 100 was open in the above description, the entire surface does not need to be open as long as there is an opening large enough to allow the guide wire 500 and external wiring to be pulled out. In other words, the area overlapping with the notch 31a does not need to be open.

[0042] Furthermore, although the above description states that the area of ​​the substrate 40 overlapping with the strain gauge 50 was separated from the cover member 32 and the substrate holding component 31 on both the ±Z sides, this is not limited to this. If there is separation on the +Z side, it is acceptable for part or all of the substrate holding component 31 to be in contact on the -Z side.

[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 that secures the guide wire along the insertion path through which the guide wire is inserted, An operating component that connects to the aforementioned holding component to operate the guide wire, Multiple strain gauges for measuring the strain of the guide wire, Equipped with, The plurality of strain gauges are located within the operating component, The operating component has a gap on the outside of the plurality of strain gauges. Torca.

2. The torquer according to claim 1, wherein the operating component comprises a cylindrical main body having the plurality of strain gauges, and a cover member positioned outside the main body at a distance from the strain gauges and held by the user.

3. The main body portion has a notch in which a part of the cylindrical shape is cut out parallel to the insertion path, The plurality of strain gauges are located on the notch, The cover member has an inner surface along the outer edge of the cylindrical shape, Torque car according to claim 2.

4. The torquer according to claim 2, wherein the cover member has a hole that penetrates between the gap and the outside.

5. The torquer according to claim 1, wherein the gap is open on the base end side of the torquer opposite to the tip direction of the guide wire.

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