WO2018228290A1 - 应变片、压力传感器以及介入医疗导管 - Google Patents

应变片、压力传感器以及介入医疗导管 Download PDF

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Publication number
WO2018228290A1
WO2018228290A1 PCT/CN2018/090483 CN2018090483W WO2018228290A1 WO 2018228290 A1 WO2018228290 A1 WO 2018228290A1 CN 2018090483 W CN2018090483 W CN 2018090483W WO 2018228290 A1 WO2018228290 A1 WO 2018228290A1
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WIPO (PCT)
Prior art keywords
sensitive
strain gauge
gate
gates
substrate
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PCT/CN2018/090483
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English (en)
French (fr)
Inventor
沈磊
苗涛
梁波
王妹
王慧
孙毅勇
Original Assignee
上海微创电生理医疗科技股份有限公司
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Application filed by 上海微创电生理医疗科技股份有限公司 filed Critical 上海微创电生理医疗科技股份有限公司
Priority to US16/622,743 priority Critical patent/US11596493B2/en
Priority to EP18817780.2A priority patent/EP3640578B1/en
Priority to ES18817780T priority patent/ES2939950T3/es
Publication of WO2018228290A1 publication Critical patent/WO2018228290A1/zh
Priority to US18/162,903 priority patent/US20230165656A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B7/00—Measuring arrangements characterised by the use of electric or magnetic techniques
    • G01B7/16—Measuring arrangements characterised by the use of electric or magnetic techniques for measuring the deformation in a solid, e.g. by resistance strain gauge
    • G01B7/18—Measuring arrangements characterised by the use of electric or magnetic techniques for measuring the deformation in a solid, e.g. by resistance strain gauge using change in resistance
    • G01B7/20—Measuring arrangements characterised by the use of electric or magnetic techniques for measuring the deformation in a solid, e.g. by resistance strain gauge using change in resistance formed by printed-circuit technique
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01B—MEASURING LENGTH, THICKNESS OR SIMILAR LINEAR DIMENSIONS; MEASURING ANGLES; MEASURING AREAS; MEASURING IRREGULARITIES OF SURFACES OR CONTOURS
    • G01B7/00—Measuring arrangements characterised by the use of electric or magnetic techniques
    • G01B7/16—Measuring arrangements characterised by the use of electric or magnetic techniques for measuring the deformation in a solid, e.g. by resistance strain gauge
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L1/00—Measuring force or stress, in general
    • G01L1/20—Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress
    • G01L1/22—Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress using resistance strain gauges
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01L—MEASURING FORCE, STRESS, TORQUE, WORK, MECHANICAL POWER, MECHANICAL EFFICIENCY, OR FLUID PRESSURE
    • G01L1/00—Measuring force or stress, in general
    • G01L1/20—Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress
    • G01L1/22—Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress using resistance strain gauges
    • G01L1/2287—Measuring force or stress, in general by measuring variations in ohmic resistance of solid materials or of electrically-conductive fluids; by making use of electrokinetic cells, i.e. liquid-containing cells wherein an electrical potential is produced or varied upon the application of stress using resistance strain gauges constructional details of the strain gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0261—Strain gauges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04—Arrangements of multiple sensors of the same type
    • A61B2562/046—Arrangements of multiple sensors of the same type in a matrix array
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0001—Catheters; Hollow probes for pressure measurement
    • A61M2025/0002—Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a strain gauge, a pressure sensor and an interventional medical catheter.
  • strain gauges are typically placed to measure the contact force of the distal end of the catheter with the tissue or vessel wall to accurately monitor the implementation of the ablation procedure to ensure a successful surgical outcome. Due to the low price, fast response, large measuring range and stable performance of strain gauges, it has been widely used in the field of interventional medicine.
  • the strain gauge is made by attaching a metal sensitive grid to a base film of plastic.
  • the metal sensitive gate is a set of parallel wires formed by a narrow conductor zigzag arrangement. When it is stretched, the sensitive gate becomes narrower and longer, and the resistance becomes larger. When it is compressed, the sensitive gate becomes thicker and shorter. The resistance becomes smaller. Then, the strain gauge is disposed on the circumferential side of the elastic body, and when the electrode on the head end of the elastic body is pressed, the elastic body is directly deformed, thereby triggering the lengthening or shortening of the sensitive grid of the strain gauge on the elastic body, thereby Causes a corresponding change in resistance.
  • strain gauges commonly used on the market are strain gauges based on copper-nickel alloys. Generally, they only have a longitudinally arranged sensitive grid, and the circumferential surface area of the grid wire is large. Although the sensitivity coefficient can reach 2.0, it is significantly affected by the external temperature. The effect is therefore that the strain gauge can only be used under conditions of dryness, no scouring and tight temperature control. However, for a cardiac radiofrequency ablation catheter, it will produce a temperature change of 25 ° C to 75 ° C during ablation in the body, resulting in a corresponding change in the ambient temperature of the field to bring a temperature error to the measurement. There are two main factors that cause temperature error in the strain gauge: first, the influence of the temperature coefficient of the resistive grid itself; second, the thermal expansion coefficient of the strain gauge base material and the test material.
  • the existing strain gauges are large in size, so that the application of the strain gauges on the ablation catheter has certain limitations and cannot be fitted in the axial direction with the ablation catheter.
  • the existing strain gauges have certain limitations, and it is necessary to develop a strain gauge, which has a small size, is easy to install on the interventional medical catheter, and has good performance in precision and sensitivity. It is also unaffected by temperature.
  • the present invention provides a strain gauge comprising a substrate and at least two sensitive gates disposed on the substrate, the at least two sensitive gates being arranged in two mutually perpendicular directions and sharing a ground port.
  • the sensitive gate includes at least one longitudinal sensitive gate and at least one lateral sensitive gate, the substrate having a first direction and a second direction, the first direction being one of a length and a width direction of the substrate The second direction is the other of the length and width directions of the substrate; at least one of the longitudinal sensitive gates is disposed along the first direction, and at least one of the laterally sensitive gates is disposed along the second direction.
  • the number of the vertical sensitive gates and the lateral sensitive gates is one, the gate width of the vertical sensitive gate is aligned with the gate length of the lateral sensitive gate or the gate length of the longitudinal sensitive gate is The gate width of the laterally sensitive gate is aligned.
  • the number of the longitudinal sensitive gates is plural, and the number of the horizontal sensitive gates is at least one; the plurality of the longitudinal sensitive gates are aligned side by side and arranged along the first direction, and any two adjacent One of the lateral sensitive gates is disposed between the longitudinal sensitive gates, and all of the longitudinal sensitive gates and the lateral sensitive gates share a grounding port;
  • the gate width of the vertical sensitive gate is aligned with the gate length of the lateral sensitive gate or the gate length of the vertical sensitive gate is aligned with the gate width of the lateral sensitive gate.
  • all of the sensitive gates share a ground lead, the ground lead is connected to the ground port, and all the sensitive gates are integrally formed.
  • the one of the common grounding leads is located on a central axis of the substrate, the central axis being parallel to one of a length and a width direction of the substrate.
  • each of the sensitive gates also has a non-grounded port, and each of the non-grounded ports of the sensitive gate is connected to a non-grounded lead, and all of the grounding leads are disposed in parallel with all of the non-grounded leads and extend in the same direction.
  • a gate width and a gate length of each of the longitudinal sensitive gate and the lateral sensitive gate are equal, and all of the longitudinal sensitive gates and the lateral sensitive gate have the same grid structure.
  • the substrate is a semi-rigid substrate.
  • the material of the substrate is selected from one or more combinations of polyimide and polyetheretherketone.
  • the substrate has a length and a width of no more than 2.0 mm.
  • the present invention also provides a pressure sensor comprising an elastomer and at least one strain gauge as described above, the strain gauge being disposed on the elastomer.
  • the strain gauges are plural, and the plurality of strain gauges are located on different circumferences of the elastic body in the circumferential direction and are arranged in a circumferential direction, and the longitudinal sensitive grating edges of each of the strain gauges are The axial arrangement of the elastomers, each of the laterally sensitive gates being arranged along the circumference of the elastomer.
  • the orthographic projections of the plurality of strain gauges in the same plane in the axial direction are evenly distributed in the circumferential direction.
  • the strain gauge is plural, and includes at least a first strain gauge and a second strain gauge;
  • the first strain gauge includes a substrate, a longitudinal sensitive gate and a lateral sensitive grid, the one longitudinal sensitive gate being arranged along an axial direction of the elastic body, the one lateral sensitive gate being along a circumference of the elastic body Arrange
  • the second strain gauge includes another base, a plurality of longitudinal sensitive gates and at least one lateral sensitive grid, and the plurality of longitudinal sensitive gates are aligned side by side and arranged along the axial direction of the elastic body, and any two adjacent One lateral sensitive gate is disposed between the longitudinal sensitive gates, the at least one lateral sensitive gate is disposed along a circumference of the elastic body, and all of the longitudinal sensitive gates and the lateral sensitive gates of the second strain gauge Share a ground port.
  • the elastic body is provided with a plurality of hollow grooves, each of the hollow grooves extending along a circumferential direction of the elastic body, and the plurality of hollow grooves are located on different circumferences of the elastic body in the axial direction. And arranged in a circumferentially staggered manner, and a strain gauge is disposed between opposite ends of each of the hollow grooves.
  • each of the opposite ends of each of the hollow slots is provided with an axial groove extending along an axial direction of the elastic body.
  • the sensitive grid of the strain gauge is axially aligned with the axial groove along the elastic body.
  • the present invention also provides an interventional medical catheter comprising a distal end of the catheter, and the distal end of the catheter is provided with a pressure sensor as described above.
  • the interventional medical catheter further comprises an electrode connected to the pressure sensor, the pressure sensor comprises a first strain gauge and a second strain gauge;
  • the first strain gauge comprises a base and a longitudinal sensitive grid And a laterally sensitive grid disposed along an axial direction of the conduit, the one laterally sensitive grid being disposed along a circumference of the conduit;
  • the second strain gauge including another substrate, a plurality of longitudinal directions a sensitive gate and at least one lateral sensitive gate, wherein the plurality of longitudinal sensitive gates are aligned side by side and arranged along an axial direction of the conduit, and one of the lateral sensitive gates is disposed between any two adjacent longitudinally sensitive gates ???said at least one lateral sensitive gate is arranged along a circumference of the conduit, all of the longitudinal sensitive gates and the lateral sensitive gate of the second strain gauge share a ground port; the first strain gauge is compared to the The second strain gauge is closer to the electrode.
  • the pressure sensor and the interventional medical catheter provided by the present invention, by sharing all the sensitive gates of the strain gauge with one grounding port, the number of grounding ports on the strain gauge can be reduced, thereby saving strain gauges on the one hand.
  • the wiring space for installation and use on the interventional medical catheter facilitates the smooth installation and use of the strain gauge on the interventional medical catheter, improves the adaptability of the strain gauge, and on the other hand reduces the size of the strain gauge, thereby shortening the pressure sensor The length of the elastomer, while reducing the size of the interventional medical catheter.
  • a plurality of longitudinal sensitive gates may be disposed on one substrate of a strain gauge according to a preferred embodiment of the present invention, and a plurality of longitudinal sensitive gates are arranged in the same direction, but one between adjacent two longitudinal sensitive gates is disposed.
  • the horizontal sensitive gate, and all the sensitive gates share a grounding port.
  • the strain gauge in the preferred embodiment of the present invention has all the sensitive gates disposed to share a single grounding port, and the size of the strain gauge integrated with the plurality of longitudinal sensitive grids is reduced as a whole, so that the hollowing of the elastic body of the pressure sensor is opened.
  • the length of the groove along the circumference of the elastomer can be machined longer, thereby allowing the strain gauges located between the opposite ends of the hollow groove to sense a stronger strain signal for better measurement.
  • FIG. 1 is a schematic structural view of a conventional strain gauge in which a longitudinal sensitive gate and a lateral sensitive gate are independent of each other;
  • FIG. 2 is an isometric view of a strain gauge according to Embodiment 1 of the present invention.
  • Figure 3 is a plan view of the strain gauge shown in Figure 2;
  • Figure 4 is a Wheatstone half bridge circuit composed of the strain gauge shown in Figure 2;
  • FIG. 5 is a schematic structural view of a pressure sensor connected to an electrode according to Embodiment 1 of the present invention.
  • FIG. 6 is a schematic view showing the three strain gauges uniformly distributed on an elastic body according to Embodiment 1 of the present invention.
  • FIG. 7 is a schematic view of a strain gauge provided on an elastic body according to a first embodiment of the present invention.
  • FIG. 8 is a schematic view showing the strain of the wire when the elastic body is stretched under force according to the first embodiment of the present invention
  • FIG. 9 is a schematic view showing the strain of the wire when the elastic body is heated and expanded according to the first embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a strain gauge according to a second embodiment of the present invention, the strain gauge includes two longitudinal sensitive gates and two lateral sensitive gates;
  • FIG. 11 is a schematic structural view of a preferred strain gauge according to Embodiment 2 of the present invention.
  • Figure 12 is a plan view of the strain gauge shown in Figure 11;
  • Figure 13 is a Wheatstone half bridge circuit composed of the strain gauge shown in Figure 10;
  • Figure 14 is a Wheatstone half bridge circuit composed of the strain gauge shown in Figure 12;
  • FIG. 15 is a schematic structural view of a pressure sensor according to Embodiment 2 of the present invention when connected to an electrode;
  • Figure 16 is a right side view of the pressure sensor of Figure 15.
  • Figure 1 provides a schematic view of the structure of a prior art strain gauge.
  • the strain gauge includes two sensitive gates 1, 2.
  • any one sensitive gate it has a grid structure S, a grounding port 3, a non-grounding port 4, and a grounding lead connected to the grounding port 3 (the grounding lead is a grid wire, and a grid of sensitive gates)
  • One end of the structure S is connected) and a non-grounded lead connected to the non-grounded port 4 (the ungrounded lead is also a wire connected to the other end of the grid structure S).
  • the ground port 3 of any one of the sensitive gates can be further connected to the power supply ground via a wire, and the ungrounded port 4 of any one of the sensitive gates can be further connected to the power output through the wire.
  • one of the sensitive grids 1 is used to sense the strain of the measured object in a first direction (such as an axial direction), and the other sensitive grid 2 is used to sense the measured object in a direction perpendicular to the first direction.
  • the strain in the second direction (such as the circumferential direction).
  • the sensitive grid 1 is arranged along the axial direction of the object to be measured such that it can be stretched or contracted in a direction parallel to the axial direction of the object to be measured, along which the sensitive grid 2 is measured.
  • the object is circumferentially arranged such that it can be stretched or shrunk in a direction parallel to the circumferential direction of the object to be measured.
  • the inventors have found that there are some problems with the above strain gauges. Specifically, the two sensitive gates 1 and 2 have a total of four ports. In actual use, the four ports need to be connected to an external power source through a single wire. Obviously, the number of connected wires is increased, thereby increasing The strain gauge is in the wiring space on the interventional medical catheter, which in turn increases the size of the interventional medical catheter.
  • the ground ports of the two sensitive gates 1 and 2 are independent of each other (that is, respectively connected to the grid structure S through a ground lead), when the two sensitive gates 1 and 2 are arranged, two The spacing formed by the person is relatively large, so that the size of the strain gauge is increased, and accordingly, the size of the corresponding interventional medical catheter is also increased, which in turn limits the smooth use of the strain gauge on the interventional medical catheter.
  • the present invention provides a strain gauge, which can reduce the usage of the grounding port, reduce the overall size of the strain gauge, and reduce the use of the strain gauge on the pressure sensor.
  • the amount of the pressure sensor can be shortened, and the size of the interventional medical catheter can be reduced, so that the limitation of the application of the strain gauge on the interventional medical catheter can be overcome, thereby improving the adaptability of the strain gauge, thereby improving the success of the interventional treatment. rate.
  • strain gauges, pressure sensors and interventional medical catheters of the present invention will be further described below with reference to Figures 2 to 16 of the specification.
  • the invention is not limited to the specific embodiment, and general replacements well known to those skilled in the art are also encompassed within the scope of the invention.
  • proximal and distal are relative orientations, relative positions, orientations of elements or actions relative to each other from the perspective of the physician using the product, although “near end” and “distal” are not Restrictive, but “proximal” generally refers to the end of the product that is near the physician during normal operation, while “distal” generally refers to the end that first enters the patient.
  • proximal generally refers to the end of the product that is near the physician during normal operation
  • distal generally refers to the end that first enters the patient.
  • Axial and “circumferential” refer to the axial direction and the circumferential direction of the elastomer, respectively.
  • FIG. 2 is an isometric view of a strain gauge 10 according to a first embodiment of the present invention
  • FIG. 3 is a plan view of the strain gauge 10 shown in FIG.
  • the strain gauge 10 includes a substrate 11 and a longitudinal sensitive gate 12 and a lateral sensitive gate 13 disposed on the substrate 11.
  • the longitudinal sensitive gate 12 is generally arranged along the axial direction of the object to be measured (ie, the direction in which the gate length L' of the longitudinal sensitive gate is located is parallel to the axial direction of the object to be measured, and the gate width W' of the longitudinally sensitive gate is located.
  • the direction is parallel to the circumferential direction of the object to be measured, and the lateral sensitive gate 13 is arranged along the direction perpendicular to the axial direction of the object to be measured (ie, the direction in which the gate width W' of the lateral sensitive gate is parallel to the axial direction of the object to be measured, but The direction of the gate length L' of the lateral sensitive gate is parallel to the circumferential direction of the object to be measured, the same below.
  • the longitudinal sensitive gate 12 is disposed along one of the length direction and the width direction of the substrate 11, and the lateral sensitive gate 13 is disposed along the other of the length direction and the width direction of the substrate 11.
  • the longitudinal sensitive gates 12 are arranged along the length direction of the substrate 11, and the lateral sensitive gates 13 are arranged along the width direction of the substrate 11 as a schematic for further explanation.
  • the length of the substrate 11 is defined by L
  • the width of the substrate 11 is defined by W.
  • the direction in which the gate length L' of the longitudinal sensitive gate 12 is located is parallel to the length direction of the substrate 11
  • the direction in which the gate width W' of the lateral sensitive gate 12 is located is parallel to the length direction of the substrate 11.
  • the length direction of the substrate 11 can be parallel to the axial direction of the object to be measured, so that the two sensitive gratings can sense the strain of the measured object in the axial direction and the circumferential direction perpendicular to the axial direction (at this time
  • the measured object is schematically defined as a cylindrical shape, a truncated cone shape, a rectangular parallelepiped or other cylindrical shape.
  • the two sensitive gratings are deformed in opposite ways, that is, when one of the sensitive gratings is elongated and deformed along its own length.
  • the other sensitive grid is shortened and deformed along its length.
  • the longitudinal sensitive gate 12 is elongated and deformed in the stretching direction
  • the lateral sensitive gate 13 is shortened in deformation perpendicular to the stretching direction.
  • the direction of expansion and contraction of the longitudinal sensitive gate 12 is parallel to the length direction of the substrate 11
  • the direction of expansion and contraction of the lateral sensitive gate 13 is parallel to the width direction of the substrate 11.
  • Each of the sensitive gates includes a grid structure 121, a non-ground port 122 and a ground port 123, a non-ground lead 124, and a ground lead 125.
  • the grid structure 121 is a set of parallel wires formed by a zigzag arrangement of narrow conductors, and the set of parallel wires has a grid shape.
  • the ungrounded port 122 and the grounded port 123 are disposed at opposite ends of the grid structure 121, and the ungrounded port 122 is connected to one end of the grid structure 121 through the non-grounding wire 124.
  • the non-grounding lead 124 is formed by extending the parallel wires provided in the foregoing manner.
  • the grounding port 123 is connected to the other end of the grid structure 121 through a grounding lead 125.
  • the grounding lead 125 can also be formed by extending parallel wires of the grid structure. .
  • the longitudinal sensitive gate 12 and the lateral sensitive gate 13 are disposed to share one ground port 123, and the one common ground port 123 can pass through the wire and the outside.
  • the grounding end of the power source is connected, and can be connected to the grating structure 121 of the longitudinal sensitive gate 12 and the lateral sensitive gate 13 through the same grounding lead 125, and thus the original four ports are reduced to three ports, thereby reducing
  • the number of wires connected to the external power supply of the strain gauges saves the space for the strain gauges when used on the interventional medical catheter, and facilitates the smooth installation and use of the strain gauges on the interventional medical catheter, thereby improving the adaptability of the strain gauges.
  • the reduction in the number of ports correspondingly reduces the size of the strain gauge, thereby reducing the size of the pressure sensor carrying the strain gauge and the interventional medical catheter, which is beneficial to reduce the cost of interventional treatment and the probability of infection of the patient, thereby improving the intervention.
  • the success rate of treatment is beneficial to reduce the cost of interventional treatment and the probability of infection of the patient, thereby improving the intervention.
  • all of the sensitive grids are integrally formed to further reduce the size of the strain gauges.
  • the longitudinal sensitive gate 12 and the lateral sensitive gate 13 are preferably arranged side by side, that is, one of the gate width W' and the gate length L' of the longitudinal sensitive gate 12 and the gate width of the lateral sensitive gate 13 Align with the other of the gate length L'. As shown in FIG.
  • the gate length L' of the longitudinal sensitive gate 12 is aligned with the gate width W' of the lateral sensitive gate 13, that is, when When the longitudinal sensitive gate 12 is arranged along the length direction of the substrate 11, the projection of the gate length L' of the longitudinal sensitive gate 12 in the longitudinal direction of the substrate 11 coincides with the gate width W' of the lateral sensitive gate 13; in other embodiments When the longitudinal sensitive gate 12 is arranged along the width direction of the substrate 11, the gate width W' of the longitudinal sensitive gate 12 is aligned with the gate length L' of the lateral sensitive gate 13, that is, the longitudinal sensitive gate 12 The projection of the gate width W' in the length direction of the substrate 11 coincides with the gate length L' of the lateral sensitive gate 13.
  • the longitudinally sensitive grating and the lateral sensitive grid arranged side by side can eliminate the strain gauge in the axial direction of the interventional medical catheter.
  • the temperature drift effect that is, the horizontally sensitive gate 13 and the longitudinal sensitive gate 12 disposed side by side, can provide temperature compensation for the strain gauge 10.
  • the “temperature drift” means that when the ambient temperature is changed, the strain gauge parameter changes, which may cause instability of the strain gauge output signal, make the measurement result unstable, and even make the strain gauge unable to work normally.
  • the temperature generated during the ablation of the distal ablation electrode will be conducted in the proximal direction through the distal end of the catheter such that the catheter has different temperatures in the axial direction, that is, The conduits have different temperatures at different axial heights.
  • the two sensitive grids are arranged side by side in the axial direction of the catheter.
  • the longitudinal sensitive gate 12 and the lateral sensitive gate 13 are arranged side by side, that is, at the same axial height, in addition to eliminating the influence of temperature drift, and each sensitive grid can better sense strain and improve signal output.
  • the strength can also further reduce the size of the strain gauge 10.
  • the three lead wires 124, 125 extend in parallel and in the same direction, preferably extending toward the proximal end of the interventional medical catheter, and extending in a direction parallel to the axial direction of the interventional medical catheter.
  • the longitudinal sensitive gate 12 and the lateral sensitive gate 13 are juxtaposed in the width direction of the substrate 11 and simultaneously aligned in the length direction of the substrate 11, thereby ensuring that the two sensitive gates can eliminate contact force measurement. The effect of temperature drift.
  • the longitudinal sensitive gate 12 and the lateral sensitive gate 13 are arranged in a square shape, that is, the maximum dimension of the profile along the length of the substrate 11 coincides with the largest dimension along the width direction of the substrate 11. More specifically, the size and shape of the grating structure 121 of the longitudinal sensitive gate 12 and the lateral sensitive gate 13 are preferably the same. Further, the grating structure 121 of each sensitive gate is more preferably square, that is, the gate width W' It is equal to the gate length L', so that the length and width of the strain gauge can be reduced at the same time, so that the size of the strain gauge is smaller.
  • the grating structure 121 of each sensitive gate may be made of a nickel-chromium alloy foil etched into a grid shape. More optional, each sensitive gate has a sensitivity coefficient of 2.2 and a resistance value between 120 ⁇ and 350 ⁇ for obtaining strain gauges with better sensitivity and accuracy.
  • the grounding lead 125 connected to the common grounding port 123 is located on the central axis of the substrate 11 (ie, collinear with the central axis), the central axis being parallel to one of the length and width directions of the substrate 11, Taking the grounding lead 125 as a reference line for installation, the mounting position of the strain gauge can be determined according to the reference line, and, in actual installation, the central axis is parallel to the axial direction of the object to be measured, so that the two sensitive grids are The same axial height of the measured object senses the strain of the measured object.
  • the substrate 11 is preferably made of a semi-rigid plastic material.
  • the material of the substrate 11 is selected from one or more combinations of a special high molecular material polyimide (PI) and polyetheretherketone (PEEK). More preferably, the substrate 11 is machined from a PEEK material such that the substrate 11 has excellent rigidity and flexibility.
  • the substrate 11 has a thickness of between 5 ⁇ m and 10 ⁇ m to impart a certain flexibility.
  • the length and width of the substrate 11 are not more than 2.0 mm, but preferably the width is between 1.5 mm and 2.0 mm, and the size of the substrate is small to facilitate the installation of the strain gauge.
  • the strain gauge 10 further includes a cover film (not shown) covering each of the sensitive grids.
  • the cover film may be made of PEEK material.
  • FIG. 4 is a Wheatstone half-bridge circuit composed of the strain gauges 10 shown in FIG. 2 and FIG. 3, wherein R0 is a fixed resistor, U0 is a power supply voltage, and U BD is an output voltage (ie, a half bridge circuit).
  • the output electrical signal) R1 represents the longitudinal sensitive gate 12, and R2 represents the lateral sensitive gate 13.
  • the change of the resistance values of R1 and R2 can be amplified into a voltage change by the Wheatstone half-bridge circuit, and the direction and magnitude of the force of the measured object can be determined by the change of the voltage.
  • U BA is the voltage that R1 has
  • U AD is the voltage that R2 has.
  • the electrical signal output by the Wheatstone half-bridge circuit is higher, which is 1.33 times that of the ordinary single-bridge output electrical signal.
  • FIG. 5 is a schematic structural view of the pressure sensor 20 connected to the ablation electrode 30 according to the first embodiment of the present invention.
  • 6 is a schematic view in which the three strain gauges 10 are uniformly distributed in the elastic body 21 of the pressure sensor 20, and
  • FIG. 7 is a schematic view showing the position where the strain gauge 10 is pasted on the elastic body 21.
  • the following embodiments are schematically illustrated with the elastomer 21 as a cylindrical hollow elastomer.
  • the pressure sensor 20 includes an elastic body 21 and at least three strain gauges 10.
  • the at least three strain gauges 10 are disposed on the outer surface of the elastomer 21 to sense axial and circumferential strain at least at three different locations of the elastomer 21.
  • the at least three strain gauges 10 are preferably located on different circumferences and are arranged offset in the circumferential direction.
  • the strain gauges 10 of the present embodiment are preferably selected to be three, which can control the cost and avoid increasing the conduit volume while satisfying the actual contact force measurement requirements.
  • the projections of the three strain gauges 10 on the same plane are preferably evenly distributed along the circumferential direction of the elastic body 21, that is, the orthographic projections of the three strain gauges 10 on the same plane are uniformly 120° in the circumferential direction. Arrange.
  • the structure of the three strain gauges 10 is taken as an illustration to further illustrate the technical solution of the present invention, but it is not limited to three strain gauges 10, and may be three or more, and three or more strain gauges are
  • the orthographic projections on the same plane are also preferably evenly distributed along the circumferential direction of the elastic body 21.
  • the distal end of the elastic body 21 can be connected to the ablation electrode 30.
  • the ablation electrode 30 is fixed on the outer surface of the elastic body 21 by epoxy or acrylic glue, or can be fixed by welding.
  • the elastic body 21 may be a flexible plastic or rubber tube or a cut metal tube.
  • the preferred material for the plastic or rubber tube is a polymer material such as TPU, PVC, PEBAX, nylon, silicone rubber or natural rubber.
  • the metal tube is preferably a metal material having a shape memory function such as nickel titanium alloy or stainless steel.
  • the metal pipe may be cut in such a manner that a hollow portion (ie, a hollow groove formed by cutting the outer wall of the elastic body 21) is formed on the surface of the pipe body, and the hollow portion may be a hollow groove along the circumferential direction or the axial direction of the elastic body 21, Or other spiral cutting hollow grooves and other cutting methods that can impart elasticity to the metal tube.
  • a hollow portion ie, a hollow groove formed by cutting the outer wall of the elastic body 21
  • the hollow portion may be a hollow groove along the circumferential direction or the axial direction of the elastic body 21, Or other spiral cutting hollow grooves and other cutting methods that can impart elasticity to the metal tube.
  • the elastic body 21 preferably has three hollow grooves 211 cut in the circumferential direction, and a strain gauge 10 is preferably disposed between opposite ends of each hollow groove 211.
  • the three hollow grooves 211 are located on different circumferences in the axial direction and are staggered in the circumferential direction. More preferably, the projections of the three hollow grooves 211 on the same plane are preferably evenly distributed along the circumferential direction of the elastic body 21, that is, the orthographic projections of the three hollow grooves 211 on the same plane are evenly arranged at 120° in the circumferential direction.
  • each of the hollow grooves 211 are respectively provided with an axial groove 212 extending along the axial direction of the elastic body 21, and the axial groove 212 is axially along the elastic body 21.
  • the length is not less than the gate width W' or the gate length L' of the sensitive gate.
  • the length of the axial groove 212 along the axial direction of the elastic body 21 is equal to the gate width W' or the gate length L', and the dimensions of the two are uniform.
  • the sticking position of the strain gauge 10 is indicated, and the grid structure 121 of the strain gauge 10 (ie, the grid region) has the largest strain in the region corresponding to the axial groove 212, and the output signal is stronger, and the measurement effect is better.
  • the gate length L' of the longitudinal sensitive gate 12 is preferably axially aligned with the axial groove 212 along the elastic body 21, and the gate width W' and the axial direction of the lateral sensitive gate 13 are The slots 212 are axially aligned along the elastomer 21.
  • each of the strain gauges 10 is preferably disposed on the same circumference as the hollow groove 211.
  • each sensitive gate has a circumferential line along the circumferential direction of the elastic body 21 corresponding to the hollow groove 211 in the circumferential direction. The centerline is on the same circumference so that the strain can be better sensed.
  • the strain gauge 10 senses The strain is the largest and the output signal is the strongest, so the measurement is the most accurate.
  • the longer the length of the hollow groove cut in the circumferential direction the larger the strain electrical signal that can be sensed by the strain gauge of the present invention. Therefore, when the size of the strain gauge provided by the present invention (here, the size of the strain gauge may be the width W or the length L) is reduced, for example, by 0.5 mm in width, it is advantageous to form a length in the circumferential direction.
  • the long hollow groove then, makes the strain electrical signal that the strain gauge can sense correspondingly stronger.
  • the strain gauge provided by the invention can also reduce the amount of ports used, and correspondingly reduce the number of wires connected to the port, for example, for strain gauges having vertical and horizontal sensitive grids, at least A 38AWG wire, then, for the entire interventional medical catheter, the wiring space inside the catheter is greatly saved, not only the cable is more convenient, but also the catheter size can be smaller.
  • this embodiment only gives the results of the strain when the elastic body is subjected to tensile stretching and thermal expansion, but the above derivation processes are also applicable to the case where the elastic body is pressed and cooled.
  • strain gauge and the pressure sensor provided in this embodiment are basically the same as those in the first embodiment, and the following description is only for different points.
  • two side-aligned longitudinal sensitive gates 12 are spaced apart along the width direction of the substrate, and the two longitudinal sensitive gates 12 are mounted in a direction parallel to the length of the substrate (ie, longitudinally sensitive).
  • the gate length L' of the gate 12 is in a direction parallel to the length direction of the substrate).
  • the two longitudinal sensitive gates 12 are disposed with two lateral sensitive gates 13 spaced along the width direction of the substrate.
  • the two lateral sensitive gates 13 are aligned side by side and the mounting direction is parallel to the width direction of the substrate (ie, laterally sensitive)
  • the gate length L' of the gate 13 is in a direction parallel to the width direction of the substrate).
  • one of the lateral sensitive gates 13 is formed in a group with one of the adjacent longitudinal sensitive gates 12, and the other of the laterally sensitive gates 13 is also formed in a group with the other longitudinally sensitive gate 12 adjacent thereto, and in each group.
  • the two sensitive gates share a grounding port. Therefore, the strain gauge 40 formed by the four sensitive grids actually has six ports, so that not only the number of wires connected to the ports is large, but also the strain gauge 40
  • the width dimension is relatively large, and the width W thereof is increased by about one time compared to the width W of the strain gauge 10 in the first embodiment.
  • the two longitudinal sensitive gates 12 are spaced apart along the width direction of the substrate and arranged side by side, and only one lateral sensitive gate 13 is disposed between the two longitudinal sensitive gates 12.
  • the two longitudinal sensitive gates 12 share a horizontal sensitive gate 13
  • the two longitudinal sensitive gates 12 share a grounding port with a laterally sensitive gate 13 , whereby the strain gauge 50 composed of the three sensitive gates.
  • the wire is used in a relatively small amount, and the width W of the strain gauge 50 can be limited to 2 mm or less.
  • the strain gauge 50 can reduce two 38AWG wires compared to the strain gauge 40, and further save the wiring space inside the conduit.
  • FIG. 13 also provides a Wheatstone half bridge circuit composed of the strain gauge 40 shown in FIG. 10
  • FIG. 14 provides another Wheatstone half bridge circuit composed of the strain gauge 50 shown in FIG. 11 and FIG. .
  • R0 is a fixed resistor
  • the resistor R1 indicated by the upward arrow is the longitudinal sensitive gate 12
  • the resistor R2 indicated by the downward arrow is the lateral sensitive gate 13.
  • the Wheatstone half-bridge circuit provided in Figure 14 has a simpler structure, less wiring, and is more convenient to calculate.
  • the present embodiment further provides a pressure sensor 60, as shown in FIG. 15 and FIG. 16, which will be described below only with respect to the point of the pressure sensor 20 in the first embodiment.
  • the pressure sensor 60 includes an elastic body 61 and at least two strain gauges disposed on the elastic body 61.
  • the at least two strain gauges are located on different circumferences of the elastic body 61 in the axial direction and are arranged in a circumferentially staggered manner.
  • the two strain gauges are respectively a first strain gauge and a second strain gauge.
  • the first strain gauge is the strain gauge 10 according to the first embodiment, and the second strain gauge is as described in the second embodiment.
  • Strain gauge 50 that is, the strain gauge 10 includes a substrate, a longitudinal sensitive gate 12, and a lateral sensitive gate 13, the strain gauge 50 including another substrate, at least two longitudinal sensitive gates 12, and at least one laterally sensitive gate 13.
  • the two strain gauges combined with the first strain gauge and the second strain gauge can also sense the strain at three different positions on the elastic body 61, thereby ensuring the actual contact force.
  • the measurement requirement has the advantage of reducing the actual amount of strain gauges on the pressure sensor 20, thereby allowing the axial length of the elastomer 61 to be made shorter, thereby correspondingly the length of the interventional medical catheter carrying the pressure sensor 60. It can also be shortened, which saves the cost of use.
  • the number of the hollow grooves 611 formed on the elastic body 61 in the circumferential direction can be reduced to at least two, preferably two, to meet the basic measurement requirements, and therefore, the length of the elastic body 61 is longer than the conventional one. Shorter.
  • a strain gauge is disposed between opposite ends of each of the hollow grooves 611.
  • each of the opposite ends of each of the hollow grooves 611 is also provided with an axial groove 612, which is the same as that of the first embodiment.
  • the distal end is connected to the pressure sensor 60, and the hardness of the distal end is relatively high relative to other places, so that the axial pressure is applied to allow the ablation electrode 30 to contact the vessel wall or tissue, then,
  • the length of the distal end of the radiofrequency ablation catheter can be shortened accordingly, which facilitates the bending of the catheter during implantation and facilitates smooth introduction.
  • the strain gauge 10 is closer to the end of the pressure sensor and the electrode than the strain gauge 50.
  • at least four wires connected to the strain gauge 50 are allowed to enter the outer surface of the elastic body 61. Wire holes on the wire to shorten the wire travel.
  • the two strain gauges 10, 50 are preferably evenly distributed at 180 in the circumferential direction of the elastic body 61.
  • the present invention also provides an interventional medical catheter comprising a catheter and a pressure sensor coupled to the distal end of the catheter, the pressure sensor being the pressure sensor provided by the present invention.
  • the interventional medical catheter also includes an electrode coupled to the pressure sensor.
  • the present invention does not limit the electrode connected to the pressure sensor to be an ablation electrode, and may also be a mapping electrode.
  • the pressure sensor is connected to the ablation electrode, and those skilled in the art should be able to modify the above description, and the description will be applied to other types of electrodes after appropriate modifications in detail.
  • the force exerted by the distal end of the catheter on the vessel wall or tissue causes the vessel wall or tissue to act on the distal end of the catheter, which is the contact force to be measured by the present invention.
  • preferred embodiments of the present invention are as described above, but are not limited to the scope disclosed in the above embodiments, for example, not limited to two longitudinal sensitive gates on one substrate, but also three or more, and The adjacent two longitudinal sensitive gates share a horizontal sensitive gate.
  • the plurality of longitudinal sensitive gates are preferably arranged side by side, and the lateral sensitive gates and the longitudinal sensitive gates are preferably aligned side by side.
  • a plurality of hollow grooves which are non-displaced on different circumferences and circumferentially may be formed in a group, and a strain gauge may be disposed between opposite ends of the set of hollow spaces.
  • the pressure sensor and the interventional medical catheter provided by the present invention, by setting all the sensitive grids of the strain gauge to share one grounding port, the number of grounding ports on the strain gauge can be reduced, and the strain gauge is saved.
  • the wiring space during installation and use of the interventional medical catheter facilitates the smooth installation and use of the strain gauge on the interventional medical catheter, improves the adaptability of the strain gauge, and on the other hand reduces the size of the strain gauge, thereby shortening the pressure sensor.
  • the length of the elastomer while reducing the size of the interventional medical catheter.
  • a plurality of longitudinal sensitive gates may be disposed on one substrate of a strain gauge according to a preferred embodiment of the present invention, and a plurality of longitudinal sensitive gates are arranged in the same direction, but one between adjacent two longitudinal sensitive gates is disposed.
  • the horizontal sensitive gate, and all the sensitive gates share a grounding port.
  • the strain gauge in the preferred embodiment of the present invention has all the sensitive gates disposed to share a single grounding port, and the size of the strain gauge integrated with the plurality of longitudinal sensitive grids is reduced as a whole, so that the hollowing of the elastic body of the pressure sensor is opened.
  • the length of the groove along the circumference of the elastomer can be machined longer, thereby allowing the strain gauges located between the opposite ends of the hollow groove to sense a stronger strain signal for better measurement.

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Abstract

一种应变片(10,40,50)、压力传感器(20,60)和介入医疗导管。应变片(10,40,50)包括基底(11)以及设置在基底(11)上的至少两个敏感栅(1,2)，至少两个敏感栅(1,2)沿两个相互垂直的方向布置并共用一个接地端口(3)。压力传感器(20,60)包括弹性体(21,61)以及设置在弹性体(21,61)上的应变片(10,40,50)。介入医疗导管包括导管远端以及设置在导管远端的压力传感器(20,60)。一方面节省了应变片(10,40,50)在介入医疗导管上安装使用时的走线空间，便于应变片(10,40,50)能够在介入医疗导管上顺利安装使用，提升了应变片(10,40,50)的适配性，另一方面减小了应变片(10,40,50)的尺寸，进而缩短压力传感器(20,60)之弹性体(21,61)的长度，同时缩减介入医疗导管的尺寸。

Description

应变片、压力传感器以及介入医疗导管 技术领域
本发明涉及医疗器械技术领域，具体涉及一种应变片、压力传感器以及介入医疗导管。
背景技术
对于心脏射频消融导管，其上通常会配置应变片来测量导管远端与组织或血管壁的接触力，以此来精确监控消融治疗的实施过程，从而确保手术的成功率。由于应变片的价格低、反应速度快、测量范围大以及性能稳定等优点，故而在介入医疗领域得到了广泛的应用。
一般地，应变片是由塑料的基底薄膜上贴上金属敏感栅制作而成。金属敏感栅为由一条窄导体曲折排列形成的一组平行导线，当其受到拉伸时，敏感栅变窄、变长，电阻变大，当其受到压缩时，敏感栅变粗、变短，电阻变小。那么，将应变片设置在弹性体的周侧，当弹性体的头端上电极受压时直接引起弹性体产生形变，进而触发该弹性体上应变片之敏感栅的变长或变短，从而引起电阻的相应改变。
目前市场上常用的电阻应变片为基于铜镍合金的应变片，一般仅具有纵向排布的敏感栅，且栅丝周表面积较大，虽然其灵敏度系数可以达到2.0，但显著地受到外界温度的影响，因此，该应变片只能在干燥、无冲刷和严格控制温度的条件下使用。然而，对于心脏射频消融导管而言，其在体内消融过程中会产生25℃～75℃的温度变化，导致现场测量环境温度相应改变而给测量带来温度误差。应变片产生温度误差的主要因素有两个：第一，敏感栅自身电阻温度系数的影响；第二，应变片基底材料和测试材料的热膨胀系数。
此外，现有的应变片尺寸较大，使得应变片在消融导管上的应用存在一定的局限性，无法与消融导管在轴向方向进行贴合。
因此，现有的应变片都有一定的局限性，很有必要开发出一种应变片，具有较小的尺寸，且在介入医疗导管上安装方便，又在精度和灵敏度上具有良好的性能，同时不受温度影响。
发明内容
本发明的目的在于提供一种应变片、压力传感器以及介入医疗导管，以解决现有技术中介入医疗导管上应变片尺寸过大，应用存在局限性的问题。
为实现上述目的，本发明提供一种应变片，包括基底以及设置在所述基底上的至少二个敏感栅，所述至少二个敏感栅沿二个相互垂直的方向布置并共用一个接地端口。
可选的，所述敏感栅包括至少一个纵向敏感栅和至少一个横向敏感栅，所述基底具有第一方向和第二方向，所述第一方向为所述基底的长度和宽度方向中的一个，所述第二方向为所述基底的长度和宽度方向中的另一个；至少一个所述纵向敏感栅沿所述第一方向布置，至少一个所述横向敏感栅沿所述第二方向布置。
可选的，所述纵向敏感栅和所述横向敏感栅的数量均为一个，所述纵向敏感栅的栅宽与所述横向敏感栅的栅长对齐或者所述纵向敏感栅的栅长与所述横向敏感栅的栅宽对齐。
可选的，所述纵向敏感栅的数量为多个，所述横向敏感栅的数量至少为一个；多个所述纵向敏感栅并排对齐且沿所述第一方向布置，且任意相邻二个所述纵向敏感栅之间设置一个所述横向敏感栅，所有所述纵向敏感栅和所述横向敏感栅共用一个接地端口；
其中，所述纵向敏感栅的栅宽与所述横向敏感栅的栅长对齐或者所述纵向敏感栅的栅长与所述横向敏感栅的栅宽对齐。
可选的，所有敏感栅共用一根接地引线，所述接地引线与所述接地端口相连接，且所有敏感栅为一体成型。
可选的，共用的所述一根接地引线位于所述基底的中轴线上，所述中轴线平行于所述基底的长度和宽度方向中的一个。
可选的，每个敏感栅还具有一个非接地端口，每个敏感栅的非接地端口连接一根非接地引线，所有的接地引线与所有的非接地引线平行设置且向同一个方向延伸。
可选的，每个所述纵向敏感栅和所述横向敏感栅的栅宽和栅长相等，且所 有所述纵向敏感栅和所述横向敏感栅的栅状结构相同。
可选的，所述基底为半刚性基底。
可选的，所述基底的材料选自聚酰亚胺以及聚醚醚酮中的一种或多种组合。
可选的，所述基底的长度和宽度均不大于2.0mm。
进一步，本发明还提供了一种压力传感器，包括弹性体以及至少一个如上所述的应变片，所述应变片设置在所述弹性体上。
可选的，所述应变片为多个，多个所述应变片位于所述弹性体轴向上的不同圆周上且沿周向错开布置，各所述应变片的所述纵向敏感栅沿所述弹性体的轴向布置，各所述横向敏感栅沿所述弹性体的周向布置。
可选的，多个所述应变片在轴向方向上在同一平面内的正投影沿周向均匀分布。
可选的，所述应变片为多个，至少包括第一应变片和第二应变片；
所述第一应变片包括一个基底、一个纵向敏感栅和一个横向敏感栅，所述一个纵向敏感栅沿所述弹性体的轴向布置，所述一个横向敏感栅沿所述弹性体的周向布置；
所述第二应变片包括另一个基底、多个纵向敏感栅和至少一个横向敏感栅，多个所述纵向敏感栅并排对齐且沿所述弹性体的轴向布置，且任意相邻二个所述纵向敏感栅之间设置一个所述横向敏感栅，所述至少一个横向敏感栅沿所述弹性体的周向布置，所述第二应变片的所有所述纵向敏感栅和所述横向敏感栅共用一个接地端口。
可选的，所述弹性体上开设有多个镂空槽，每个所述镂空槽沿所述弹性体的周向延伸，多个所述镂空槽位于所述弹性体轴向上的不同圆周上且沿周向错开布置，且每个所述镂空槽的相对两端之间设置有一个应变片。
可选的，每个所述镂空槽的相对两端各设置有一个轴向槽，所述轴向槽沿所述弹性体的轴向延伸。
可选的，所述应变片的敏感栅与所述轴向槽沿所述弹性体轴向对齐。
更进一步的，本发明还提供了一种介入医疗导管，包括导管远端，且所述导管远端设置有如上所述的压力传感器。
可选的，所述介入医疗导管还包括与所述压力传感器相连接的电极，所述压力传感器包括第一应变片和第二应变片；所述第一应变片包括一个基底、一个纵向敏感栅和一个横向敏感栅，所述一个纵向敏感栅沿所述导管的轴向布置，所述一个横向敏感栅沿所述导管的周向布置；所述第二应变片包括另一个基底、多个纵向敏感栅和至少一个横向敏感栅，多个所述纵向敏感栅并排对齐且沿所述导管的轴向布置，且任意相邻二个所述纵向敏感栅之间设置一个所述横向敏感栅，所述至少一个横向敏感栅沿所述导管的周向布置，所述第二应变片的所有所述纵向敏感栅和所述横向敏感栅共用一个接地端口；所述第一应变片相较于所述第二应变片更靠近所述电极。
综上所述，在本发明提供的应变片、压力传感器以及介入医疗导管中，通过将应变片的所有敏感栅共用一个接地端口，可以减少应变片上接地端口的数量，从而一方面节省了应变片在介入医疗导管上安装使用时的走线空间，便于应变片能够在介入医疗导管上顺利安装使用，提升了应变片的适配性，另一方面减小了应变片的尺寸，进而缩短压力传感器之弹性体的长度，同时缩减介入医疗导管的尺寸。
此外，在本发明较佳实施例的一个应变片的一个基底上可以设置多个纵向敏感栅，且多个纵向敏感栅沿同一方向布置，但相邻二个纵向敏感栅之间还设置有一个横向敏感栅，并且所有敏感栅共用一个接地端口，这样的设置，可以减少压力传感器上应变片的使用数量，即应变片的数量可以由原来的至少三个减少至至少二个，从而可以减小压力传感器的长度，进而可以缩小介入医疗导管远端的长度，降低使用成本。
另外，本发明较佳实施例中的应变片将所有敏感栅设置为共用一个接地端口，整体上缩减了集成有多个纵向敏感栅的应变片的尺寸，使得压力传感器之弹性体上开设的镂空槽沿弹性体周向的长度可以加工得更长，由此使得位于该镂空槽相对二端之间的应变片能够感测到更强的应变信号，测量效果更好。
附图说明
图1是一种传统的应变片的结构示意图，其中纵向敏感栅和横向敏感栅相 互独立；
图2是本发明实施例一提供的应变片的等轴视图；
图3是图2所示的应变片的俯视图；
图4是图2所示应变片所组成的惠斯通半桥电路；
图5是本发明实施例一提供的压力传感器与电极相连时的结构示意图；
图6是本发明实施例一提供的三个应变片在弹性体上均匀分布的示意图；
图7是本发明实施例一提供的应变片在弹性体上安装时的示意图；
图8是本发明实施例一提供的弹性体在受力拉伸时栅丝的应变示意图；
图9是本发明实施例一提供的弹性体在受热膨胀时栅丝的应变示意图；
图10是本发明实施例二提供的应变片的结构示意图，该应变片包括二个纵向敏感栅和二个横向敏感栅；
图11是本发明实施例二提供的优选应变片的结构示意图；
图12是图11所示应变片的俯视图；
图13是图10所示应变片所组成的惠斯通半桥电路；
图14是图12所示应变片所组成的惠斯通半桥电路；
图15是本发明实施例二提供的压力传感器与电极相连时的结构示意图；
图16是图15所示压力传感器的右视图。
图中的附图标记说明如下：
1、2-敏感栅；3-接地端口；4-非接地端口；
10、40、50-应变片；11-基底；12-纵向敏感栅；121-栅状结构；122-非接地端口；123-接地端口；124-非接地引线；125-接地引线；13-横向敏感栅；
20、60-压力传感器；21、61-弹性体；211、611-镂空槽；212、612-轴向槽；
30-消融电极。
具体实施方式
图1提供了一种现有应变片的结构示意图。如图1所示，该应变片包括二个敏感栅1、2。针对任意一个敏感栅，其具有一个栅状结构S、一个接地端口3、一个非接地端口4、与接地端口3相连的一根接地引线(该接地引线是一栅丝， 与敏感栅之栅状结构S的一端相连)以及与非接地端口4相连的一根非接地引线(该非接地引线亦是一根栅丝，与栅状结构S的另一端相连)。任意一个敏感栅的接地端口3可进一步通过导线与电源接地端连接，任意一个敏感栅的非接地端口4可进一步通过导线与电源输出端连接。
实际使用时，其中一个敏感栅1用于感测被测物体在第一方向(比如轴向)上的应变，另一个敏感栅2用于感测所述被测物体在垂直于第一方向的第二方向(比如周向)上的应变。举例来说，所述敏感栅1沿被测物体的轴向布置，以使其在平行于测被测物体轴向的方向上能够被拉伸或收缩，所述敏感栅2沿所述被测物体的周向布置，以使其在平行于被测物体周向的方向上能够被拉伸或收缩。
但是，发明人研究发现，上述应变片存在一些问题。具体来说，所述二个敏感栅1、2总共具有四个端口，实际使用时，该四个端口需分别通过一根导线与外部电源连接，显然，连接的导线数量较多，从而增加了该应变片在介入医疗导管上的走线空间，进而会加大介入医疗导管的尺寸。另外，由于该二个敏感栅1、2的接地端口相互独立(即分别通过一根接地引线与栅状结构S连接)，这样一来，在排设该二个敏感栅1、2时，两者形成的间距比较大，那么便会加大该应变片的尺寸，相应地，其对应的介入医疗导管的尺寸也随之增加，进而会限制该应变片在介入医疗导管上的顺利使用。
为此，基于上述应变片所存在的技术问题，本发明提供了一种应变片，不但能够减少接地端口的使用量，减小应变片的整体尺寸，而且还可以减少压力传感器上应变片的使用量，从而缩短压力传感器的长度，同时还可以缩减介入医疗导管的尺寸，故而可以克服应变片在介入医疗导管上应用的局限性，从而提升应变片的适配性，进而可以提升介入治疗的成功率。
为使本发明的内容更加清楚易懂，以下结合说明书附图2～16，对本发明的应变片、压力传感器以及介入医疗导管做进一步说明。当然本发明并不局限于该具体实施例，本领域的技术人员所熟知的一般替换也涵盖在本发明的保护范围内。
其次，本发明利用示意图进行了详细的表述，但这些示意图仅为了便于详 述本发明实例，不应对此作为本发明的限定。
在本文中，“近端”和“远端”是从使用产品的医生角度来看相对于彼此的元件或动作的相对方位、相对位置、方向，尽管“近端”和“远端”并非是限制性的，但是“近端”通常指该产品在正常操作过程中靠近医生的一端，而“远端”通常是指首先进入患者体内的一端。“轴向”和“周向”分别指弹性体的轴线方向及圆周面方向。
如在本说明书和所附权利要求中所使用的，单数形式“一”、“一个”以及“该”包括复数对象，除非内容另外明确指出外。如在本说明书和所附权利要求中所使用的，术语“或”通常是以包括“和/或”的含义而进行使用的，除非内容另外明确指出外。
<实施例一>
图2是本发明实施例一提供的应变片10的等轴视图，图3是图2所示的应变片10的俯视图。如图2和图3所示，所述应变片10包括基底11以及设置在基底11上的一个纵向敏感栅12和一个横向敏感栅13。在此，纵向敏感栅12通常是沿被测物体的轴向布置(即纵向敏感栅的栅长L’所在的方向平行于被测物体的轴向，而纵向敏感栅的栅宽W’所在的方向平行于被测物体的周向)，横向敏感栅13是沿被测物体垂直于轴向的方向布置(即横向敏感栅的栅宽W’所在的方向平行于被测物体的轴向，但横向敏感栅的栅长L’所在的方向平行于被测物体的周向)，下同。
本实施例中，所述纵向敏感栅12沿基底11的长度方向和宽度方向中的一个布置，所述横向敏感栅13沿基底11的长度方向和宽度方向中的另一个布置。以下为了便于叙述，以纵向敏感栅12沿基底11的长度方向布置，以及横向敏感栅13沿基底11的宽度方向布置作为示意来进一步说明。
本文中，基底11的长度以L定义，基底11的宽度以W定义。其中，所述纵向敏感栅12的栅长L’所在的方向平行于基底11的长度方向，所述横向敏感栅12的栅宽W’所在的方向平行于基底11的长度方向。实际使用时，可令基底11的长度方向平行于被测物体的轴向，从而使得该二个敏感栅可以感测被测物体在轴向以及垂直于轴向之周向上的应变(此时的被测物体示意性定义为圆 柱形、圆台形、长方体或其他柱形)，显然在应变的作用下，该二个敏感栅的变形方式相反，即当其中一个敏感栅沿自身长度方向伸长变形时，另一个敏感栅则沿自身长度方向缩短变形。具体的，当沿基底11的长度方向拉伸被测物体时，所述纵向敏感栅12沿拉伸方向伸长变形，而所述横向敏感栅13在垂直于拉伸方向缩短变形。换而言之，所述纵向敏感栅12的伸缩方向平行于基底11的长度方向，所述横向敏感栅13的伸缩方向平行于基底11的宽度方向。
其中，每个敏感栅均包括一个栅状结构121、非接地端口122和接地端口123、非接地引线124和接地引线125。所述栅状结构121为由一条窄导体曲折排列形成的一组平行导线，该一组平行导线呈栅状。对于任一个敏感栅来说，所述非接地端口122和接地端口123设置在栅状结构121的相对两端，且所述非接地端口122通过非接地引线124与栅状结构121的一端相连，该非接地引线124为前述设置的平行导线延伸形成，所述接地端口123通过一根接地引线125与栅状结构121的另一端相连，该接地引线125同样可为栅状结构之平行导线延伸形成。
进而，为了节省应变片上与外部电源的接地端连接的接地端口数量，将所述纵向敏感栅12和横向敏感栅13设置为共用一个接地端口123，该一个共用的接地端口123可通过导线与外部电源的接地端连接，且可通过同一根接地引线125分别与纵向敏感栅12和横向敏感栅13的栅状结构121相连，如此设置，便将原本的四个端口缩减至三个端口，从而减少应变片与外部电源连接的导线数量，进而一方面节省了应变片在介入医疗导管上使用时的走线空间，便于应变片能够在介入医疗导管上顺利安装使用，提升了应变片的适配性，另一方面端口数量的减少相应缩小了应变片的尺寸，进而减小了携带该应变片的压力传感器以及介入医疗导管的尺寸，有利于降低介入治疗的成本以及患者感染的机率，从而提升介入治疗的成功率。
较佳地，所有敏感栅一体成型，可以进一步缩小应变片的尺寸。
本实施例中，所述纵向敏感栅12和横向敏感栅13优选并排对齐设置，即所述纵向敏感栅12的栅宽W’和栅长L’中的一个与横向敏感栅13的栅宽W’和栅长L’中的另一个对齐。如图2所示，当所述纵向敏感栅12沿基底11的长度 方向布置时，所述纵向敏感栅12的栅长L’与横向敏感栅13的栅宽W’相对齐，即当所述纵向敏感栅12沿基底11的长度方向布置时，所述纵向敏感栅12的栅长L’在基底11长度方向上的投影与所述横向敏感栅13的栅宽W’重合；在其他实施例中，当所述纵向敏感栅12沿基底11的宽度方向布置时，所述纵向敏感栅12的栅宽W’与横向敏感栅13的栅长L’相对齐，即所述纵向敏感栅12的栅宽W’在基底11长度方向上的投影与所述横向敏感栅13的栅长L’重合。
更为具体的，当所述基底11的长度方向与被测物体，如介入医疗导管的轴向平行时，并排对齐设置的纵向敏感栅和横向敏感栅可以消除应变片在介入医疗导管轴向上的温度漂移影响，即并排对齐设置的横向敏感栅13和纵向敏感栅12可以为应变片10提供温度补偿功能。在此，所述“温度漂移”是指，测量环境温度变化时会引起应变片参数的变化，这样会造成应变片输出信号的不稳定，使测量结果不稳定，甚至使应变片无法正常工作。例如，针对射频消融导管，其远端的消融电极在体内消融过程中产生的温度，将通过导管的远端向近端方向进行传导，使得导管在轴向上具有不同的温度，也就是说，导管在不同轴向高度所具有的温度并不相同。因而，为了能够消除在同一测量温度下的温漂(温度漂移的简称)影响，该二个敏感栅在导管轴向上并排对齐设置。将所述纵向敏感栅12和横向敏感栅13并排对齐设置，即位于同一轴向高度处，除可以消除温漂的影响，还可以使得每个敏感栅可以更好地感受应变，提高信号输出的强度，也可以进一步缩减应变片10的尺寸。
其中，为了得到尺寸较小的应变片10，三根引线124、125平行且朝同一个方向延伸，较佳地朝向介入医疗导管的近端方向延伸，且延伸方向平行于介入医疗导管的轴线方向。结合图3来说，所述纵向敏感栅12和横向敏感栅13在基底11的宽度方向上并排，且同时在基底11的长度方向上对齐，以此确保该二个敏感栅能够消除接触力测量时温漂的影响。
更优选的，所述纵向敏感栅12和横向敏感栅13排布形成的轮廓为正方形，即该轮廓在沿基底11长度方向的最大尺寸与沿基底11宽度方向的最大尺寸一致。更为具体的，所述纵向敏感栅12和横向敏感栅13之栅状结构121的尺寸 和形状优选为相同，此外，每个敏感栅的栅状结构121更优选为正方形，即栅宽W’和栅长L’相等，这样可以同时缩减应变片的长度和宽度，使应变片的尺寸更小。可选，每个敏感栅的栅状结构121可以由镍铬合金箔腐蚀成栅状制成。更可选，每个敏感栅的灵敏度系数为2.2，且电阻值在120Ω～350Ω之间，以获取灵敏度和精度更好的应变片。
可选的，与所述一个共同的接地端口123相连的接地引线125位于基底11的中轴线上(即与中轴线共线)，该中轴线平行于基底11的长度和宽度方向中的一个，以将该接地引线125作为安装时的参考线，根据该参考线可以确定应变片的安装位置，而且，实际安装时，该中轴线平行于被测物体的轴向，以令二个敏感栅在被测物体的同一轴向高度感测被测物体的应变。
本实施例中，所述基底11优选由半刚性塑料材料制成。例如，所述基底11的材料选自特种高分子材料聚酰亚胺(PI)以及聚醚醚酮(PEEK)中的一种或多种组合。更优选，所述基底11采用PEEK材料加工而成，使得基底11具有优异的刚性和柔性。可选，所述基底11的厚度在5μm～10μm之间，以赋予其一定的柔韧性。可选，所述基底11的长度和宽度均不大于2.0mm，但优选宽度在1.5mm～2.0mm之间，基底的尺寸较小便于应变片的安装使用。
进一步的，所述应变片10还包括覆盖膜(未图示)，覆盖在每个敏感栅之上，另外，所述覆盖膜可选用PEEK材质。当所述半刚性的基底11和覆盖膜均具备一定的柔韧性时，该应变片10可用于曲率较高的表面上，有助于应变片的安装使用。
接着，参阅图4，其为图2和图3所示应变片10所构成的惠斯通半桥电路，其中，R0是固定电阻，U0是电源电压，U BD是输出电压(即半桥电路输出的电信号)，R1代表的是纵向敏感栅12，R2代表的是横向敏感栅13。
根据图4所示，R1和R2阻值的变化可通过惠斯通半桥电路放大为电压的变化，即可通过电压的变化来确定被测物体受力的方向和大小。
其中，U BD＝U BA-U AD
U BA为R1所具有的电压，U AD为R2所具有的电压。
进一步的，U BD所反映的应变大小为：
ε force＝ε force1-ε force2
当所述纵向敏感栅12的栅丝变长，R1电阻变大，即对应为正应变ε force1，与此同时，所述横向敏感栅13的栅丝缩短，R2电阻变小，即对应为负应变ε force2。
进而，根据材料泊松比原理：ε force2＝-ν*ε force1
其中，ν为泊松比，且一般为0.33。即ε force＝1.33*ε force1。
相比于单桥电路，采用该惠斯通半桥电路输出的电信号质量更高，是普通单桥输出电信号的1.33倍。
更进一步的，本实施例还提供了一种压力传感器20，具体如图5至图7所示，图5是本发明实施例一提供的压力传感器20与消融电极30相连时的结构示意图，图6是三个应变片10在压力传感器20之弹性体21均匀分布的示意图，图7是应变片10在弹性体21上粘贴位置的示意图。本文中，以弹性体21为圆柱形中空弹性体示意来描述下述实施例。
具体来说，所述压力传感器20包括弹性体21和至少三个应变片10。该至少三个应变片10设置在弹性体21的外表面上，以至少在弹性体21的三个不同位置感测轴向和周向应变。该至少三个应变片10优选位于不同的圆周上且沿周向错开布置。
本实施例的应变片10较佳地选择为三个，可在满足实际的接触力测量要求的前提下控制成本并避免增大导管体积。如图6所示，所述三个应变片10在同一平面上的投影优选沿弹性体21的周向均匀分布，即三个应变片10在同一平面上的正投影沿周向呈120°均匀排布。
以下实施例中均以三个应变片10的结构作为示意，来进一步说明本发明的技术方案，但包括且不限于三个应变片10，还可以是三个以上，三个以上的应变片在同一平面上的正投影同样较佳地在沿弹性体21的周向均匀分布。
继续参考图5，所述弹性体21的远端可与消融电极30相连，例如消融电极30通过环氧类或丙烯酸类胶水固定在弹性体21的外表面上，也可以通过焊接的方式固定在弹性体21的外表面上。所述弹性体21可以是具有弹性的塑料或橡胶管，也可以是经切割的金属管。塑料或橡胶管优选的材料是TPU、PVC、PEBAX、尼龙、硅橡胶或天然橡胶等高分子材料。金属管优选具有形状记忆功 能的金属材料，如镍钛合金或不锈钢等。金属管的切割方式可以是在管体表面刻设有镂空部(即切透弹性体21的外壁形成的镂空槽)，该镂空部可以是沿弹性体21的圆周方向或轴向的镂空槽，或者是螺旋形的镂空槽等其他可赋予金属管弹性的切割方式。
本实施例中，所述弹性体21较佳地具有三个沿圆周方向切割的镂空槽211，且每个镂空槽211的相对两端之间较佳地设置有一个应变片10。在本发明实施例中，三个镂空槽211在轴向上位于不同的圆周上且沿周向错开分布。更优选的，该三个镂空槽211在同一平面上的投影优选沿弹性体21的周向均匀分布，即三个镂空槽211在同一平面上的正投影沿周向呈120°均匀排布。
一个优选方案中，每个镂空槽211的相对两端分别设置有一个轴向槽212，该轴向槽212沿弹性体21的轴向延伸，且该轴向槽212沿弹性体21轴向的长度不小于敏感栅的栅宽W’或栅长L’，优选地所述轴向槽212沿弹性体21轴向的长度与栅宽W’或栅长L’相等，二者的尺寸一致便于指示应变片10的粘贴位置，且应变片10的栅状结构121(即栅区)在对应于轴向槽212所在区域的应变最大，输出的信号更强，测量效果更好。实际安装时，如图7所示，所述纵向敏感栅12的栅长L’优选与轴向槽212沿弹性体21轴向对齐，且所述横向敏感栅13的栅宽W’与轴向槽212沿弹性体21轴向对齐。
此外，每个应变片10优选与镂空槽211设置在同一圆周上，具体的，针对一个应变片10，其每个敏感栅沿弹性体21周向的中心线与镂空槽211相应沿周向的中心线在同一个圆周上，这样可以更好地感测应变。另外，经实验分析得到，当所述应变片10沿弹性体21轴向的中轴线与弹性体21的轴线平行，以及其敏感栅与轴向槽212对齐时，所述应变片10感测的应变最大，输出的信号最强，因此，测量最为精确。
一般地，沿圆周方向切割的镂空槽的长度越长，本发明的应变片所能感测到的应变电信号越大。因此，当本发明提供的应变片的尺寸(本文中，应变片的尺寸可以是宽度W，也可以是长度L)减小时，比如在宽度上缩减0.5mm，则有利于在圆周方向形成长度更长的镂空槽，那么，使得应变片所能感测到的应变电信号相应更强。另外，与现有相比，本发明提供的应变片还可以减少其 端口的使用量，相应地减少与端口相连的导线数量，比如对于具有纵、横敏感栅的应变片来说，至少可以减少一根38AWG导线，那么，对于整个介入医疗导管来说，较大节省了导管内部的走线空间，不仅排线更为方便，而且导管尺寸可以更小。
接着，再结合图8和图9，更为详细说明本实施例的应变测量原理。首先，参阅图8，当所述压力传感器20的弹性体21受力F在轴向上被拉伸时，所述纵向敏感栅12的栅丝变长，R1电阻变大，产生正应变ε force1，同时所述横向敏感栅13受压N在周向上被压缩，其栅丝变短，R2电阻变小，产生负应变ε force2，那么，根据ε force1和ε force2，可以获得最终的应变ε force。
之后，参阅图9，当所述压力传感器20的弹性体21受热膨胀时，该弹性体21沿各个方向受拉F，但各个方向的膨胀量相同。其中，所述纵向敏感栅12和横向敏感栅13的栅丝均被拉伸，R1、R2电阻变大，从而分别产生正应变ε tem1和ε tem2，ε tem1对应于纵向敏感栅12，ε tem2对应于横向敏感栅13，而ε tem1和ε tem2的大小相同，那么，通过图4所示的惠斯通半桥电路可以得到总的应变ε tem＝ε tem1-ε tem2，即为零，也就是说，具有纵、横敏感栅的应变片所组成的惠斯通半桥电路可以完全消除温漂的影响。
此外，当所述弹性体21同时受力拉伸和受热膨胀时，总的应变ε comb＝ε force+ε tem，其中，ε tem始终为零，因此，ε comb＝ε force。
另外，本实施例只给出了弹性体受力拉伸和受热膨胀时的应变结果，但是，上述这些推导过程同样适用于弹性体受压和受冷等情况。
<实施例二>
本实施例中提供的应变片、压力传感器与实施例一基本相同，以下仅针对不同点进行描述。
为了减少弹性体上应变片的使用量，发明人发现，可以在同一个基底上设置至少二个纵向敏感栅，同样可以保证实际的接触力测量要求。为了便于叙述，以二个纵向敏感栅作为示意，对本实施例的技术方案作进一步的说明。
在一种做法中，如图10所示，二个并排对齐的纵向敏感栅12沿基底的宽度方向间隔布置，且该二个纵向敏感栅12的安装方向平行于基底的长度方向(即 纵向敏感栅12的栅长L’所在的方向平行于基底的长度方向)。其中，该二个纵向敏感栅12之间设置有沿基底的宽度方向间隔布置的二个横向敏感栅13，该二个横向敏感栅13并排对齐且安装方向平行于基底的宽度方向(即横向敏感栅13的栅长L’所在的方向平行于基底的宽度方向)。
图10中，其中一个横向敏感栅13与其相邻的一个纵向敏感栅12形成一组，另一个横向敏感栅13同样与其相邻的另一个纵向敏感栅12形成一组，且在每一组中，二个敏感栅共用一个接地端口，由此，由该四个敏感栅所构成的应变片40实际对应有六个端口，故而，不但与这些端口连接的导线数量较多，而且应变片40的宽度尺寸相对较大，其宽度W相比于实施例一中应变片10的宽度W，将增大一倍左右。
在另一种做法中，如图11和图12所示，二个纵向敏感栅12沿基底的宽度方向间隔且并排对齐布置，且该二个纵向敏感栅12之间仅设置一个横向敏感栅13，以使该二个纵向敏感栅12共用一个横向敏感栅13，且二个纵向敏感栅12与一个横向敏感栅13共用一个接地端口，由此，由该三个敏感栅所构成的应变片50实际只需四个端口，即仅需连接四根导线，因此，导线的使用量相对较少，而且该应变片50的宽度W可以限定在2mm以内，尺寸相对较小。本实施例中，所述应变片50相较于前述应变片40，可以减少二根38AWG导线，更进一步节省了导管内部的走线空间。
此外，图13还提供了图10所示应变片40所组成的惠斯通半桥电路，以及图14提供了图11和图12所示应变片50所组成的另一惠斯通半桥电路。其中，R0是固定电阻，向上箭头所指的电阻R1为纵向敏感栅12，向下箭头所指的电阻R2为横向敏感栅13。显然，图14提供的惠斯通半桥电路，结构更为简单，接线更少，且计算更为方便。
进一步的，本实施例另提供了一种压力传感器60，具体如图15和图16所示，以下仅针对与实施例一中的压力传感器20相区别的点进行说明。
所述压力传感器60包括弹性体61以及设置在弹性体61上的至少二个应变片，该至少二个应变片位于弹性体61沿轴向的不同圆周上且沿周向错开布置。以二个应变片为例，分别是第一应变片和第二应变片，所述第一应变片采用实 施例一所述的应变片10，所述第二应变片采用实施例二所述的应变片50。也就是说，所述应变片10包括一个基底、一个纵向敏感栅12和一个横向敏感栅13，所述应变片50包括另一个基底、至少二个纵向敏感栅12以及至少一个横向敏感栅13。
与前述压力传感器20所不同的是，所述第一应变片和第二应变片相结合组成的二个应变片同样可以感测弹性体61上三个不同位置的应变，保证了接触力的实际测量要求，然而，优点在于减少了压力传感器20上应变片的实际使用量，由此令弹性体61的轴向长度可以做得更短，从而，携带该压力传感器60的介入医疗导管的长度相应也可以缩短，便节省了使用成本。
继而，所述弹性体61上沿周向切割形成的镂空槽611之数量可缩减至至少二个，较佳地为二个即可满足基本测量要求，因此，弹性体61的长度相较传统的更短。与实施例一相同的，每个镂空槽611的相对两端之间设置一个应变片即可。当然，每个镂空槽611的相对两端还各设置有一个轴向槽612，与实施例一相同。
结合射频消融导管来说，其远端与压力传感器60相连，且远端的硬度相对于其它地方的硬度高，以便于轴向施压使消融电极30能够与血管壁或组织接触，那么，为了获取较好的柔顺性，该射频消融导管远端的长度可以相应缩短，有利于导管在植入过程中弯曲，便于顺利导入。
在一个优选方案中，所述应变片10相对于应变片50更为靠近压力传感器与一电极相连的一端，该情况下，有利于与应变片50连接的至少四根导线进入弹性体61外表面上的导线孔，从而缩短导线行程。如图16所示，所述二个应变片10、50优选沿弹性体61的圆周方向呈180°均匀分布。
最后，基于上述实施例，本发明还提供了一种介入医疗导管，其包括导管以及与该导管远端连接的压力传感器，该压力传感器即为本发明提供的压力传感器。所述介入医疗导管还包括与压力传感器连接的电极。然而，本发明并不限定与压力传感器连接的电极为消融电极，也可以为标测电极。为了简明起见，在上述描述中假设与压力传感器连接的为消融电极，本领域技术人员应当能够修改上述描述，在细节上作适当修改后将所述描述用于其它类型的电极。导管 远端对血管壁或组织施加的力，使血管壁或组织作用于导管远端上的反作用力，该反作用力即是本发明所要测量的接触力。
此外，本发明较佳实施例如上所述，但并不限于上述实施例所公开的范围，例如不限于一个基底上仅设置二个纵向敏感栅，还可以是三个或三个以上，且相邻二个纵向敏感栅共用一个横向敏感栅即可。其中，多个纵向敏感栅较佳为并排对齐设置，且横向敏感栅与纵向敏感栅较佳为并排对齐。另外，在不同圆周上且周向非错开的多个镂空槽可以构成一组，在该一组镂空槽的相对两端之间可设置一个应变片。
综上所述，在本发明提供的应变片、压力传感器以及介入医疗导管中，通过将应变片的所有敏感栅设置为共用一个接地端口，可以减少应变片上接地端口的数量，节省了应变片在介入医疗导管上安装使用时的走线空间，便于应变片能够在介入医疗导管上顺利安装使用，提升了应变片的适配性，另一方面减小了应变片的尺寸，进而缩短压力传感器之弹性体的长度，同时缩减介入医疗导管的尺寸。
此外，在本发明较佳实施例的一个应变片的一个基底上可以设置多个纵向敏感栅，且多个纵向敏感栅沿同一方向布置，但相邻二个纵向敏感栅之间还设置有一个横向敏感栅，并且所有敏感栅共用一个接地端口，这样的设置，可以减少压力传感器上应变片的数量，即应变片的数量可以由原来的至少三个减少至至少二个，从而可以减小压力传感器的长度，进而可以缩小介入医疗导管远端的长度，降低使用成本。
另外，本发明较佳实施例中的应变片将所有敏感栅设置为共用一个接地端口，整体上缩减了集成有多个纵向敏感栅的应变片的尺寸，使得压力传感器之弹性体上开设的镂空槽沿弹性体周向的长度可以加工得更长，由此使得位于该镂空槽相对二端之间的应变片能够感测到更强的应变信号，测量效果更好。
上述描述仅是对本发明较佳实施例的描述，并非对本发明范围的任何限定，本发明领域的普通技术人员根据上述揭示内容做的任何变更、修饰，均属于权利要求书的保护范围。

Claims (20)

  1. 一种应变片，其特征在于，包括基底以及设置在所述基底上的至少二个敏感栅，所述至少二个敏感栅沿二个相互垂直的方向布置并共用一个接地端口。
  2. 根据权利要求1所述的应变片，其特征在于，所述敏感栅包括至少一个纵向敏感栅和至少一个横向敏感栅，所述基底具有第一方向和第二方向，所述第一方向为所述基底的长度和宽度方向中的一个，所述第二方向为所述基底的长度和宽度方向中的另一个；至少一个所述纵向敏感栅沿所述第一方向布置，至少一个所述横向敏感栅沿所述第二方向布置。
  3. 根据权利要求2所述的应变片，其特征在于，所述纵向敏感栅和所述横向敏感栅的数量均为一个，且所述纵向敏感栅的栅宽与所述横向敏感栅的栅长对齐或者所述纵向敏感栅的栅长与所述横向敏感栅的栅宽对齐。
  4. 根据权利要求2所述的应变片，其特征在于，所述纵向敏感栅的数量为多个，所述横向敏感栅的数量至少为一个；多个所述纵向敏感栅并排对齐且沿所述第一方向布置，且任意相邻二个所述纵向敏感栅之间设置一个所述横向敏感栅，所有所述纵向敏感栅和所述横向敏感栅共用一个接地端口；
    其中，所述纵向敏感栅的栅宽与所述横向敏感栅的栅长对齐或者所述纵向敏感栅的栅长与所述横向敏感栅的栅宽对齐。
  5. 根据权利要求1-4中任一项所述的应变片，其特征在于，所有敏感栅共用一根接地引线，所述接地引线与所述接地端口相连接，且所有敏感栅为一体成型。
  6. 根据权利要求5所述的应变片，其特征在于，共用的所述一根接地引线位于所述基底的中轴线上，所述中轴线平行于所述基底的长度和宽度方向中的一个。
  7. 根据权利要求5所述的应变片，其特征在于，每个敏感栅还具有一个非接地端口，每个敏感栅的非接地端口连接一根非接地引线，所有的接地引线与所有的非接地引线平行设置且向同一个方向延伸。
  8. 根据权利要求7所述的应变片，其特征在于，每个所述纵向敏感栅和所述横向敏感栅的栅宽和栅长相等，且所有所述纵向敏感栅和所述横向敏感栅的栅状结构相同。
  9. 根据权利要求1-4中任一项所述的应变片，其特征在于，所述基底为半刚性基底。
  10. 根据权利要求9所述的应变片，其特征在于，所述基底的材料选自聚酰亚胺以及聚醚醚酮中的一种或多种组合。
  11. 根据权利要求1-4中任一项所述的应变片，其特征在于，所述基底的长度和宽度均不大于2.0mm。
  12. 一种压力传感器，其特征在于，包括弹性体以及至少一个如权利要求1-11中任一项所述的应变片，所述应变片设置在所述弹性体上。
  13. 根据权利要求12所述的压力传感器，其特征在于，所述应变片为多个，多个所述应变片位于所述弹性体轴向上的不同圆周上且沿周向错开布置，各所述应变片的所述纵向敏感栅沿所述弹性体的轴向布置，各所述横向敏感栅沿所述弹性体的周向布置。
  14. 根据权利要求12所述的压力传感器，其特征在于，多个所述应变片在轴向方向上在同一平面内的正投影沿周向均匀分布。
  15. 根据权利要求13所述的压力传感器，其特征在于，所述应变片为多个，至少包括第一应变片和第二应变片，所述第一应变片为权利要求3所述的应变片；所述第二应变片为权利要求4所述的应变片。
  16. 根据权利要求12所述的压力传感器，其特征在于，所述弹性体上开设有多个镂空槽，每个所述镂空槽沿所述弹性体的周向延伸，多个所述镂空槽位于所述弹性体轴向上的不同圆周上且沿周向错开布置，且每个所述镂空槽的相对两端之间设置有一个应变片。
  17. 根据权利要求16所述的压力传感器，其特征在于，每个所述镂空槽的相对两端各设置有一个轴向槽，所述轴向槽沿所述弹性体的轴向延伸。
  18. 根据权利要求17所述的压力传感器，其特征在于，所述应变片的敏感栅与所述轴向槽沿所述弹性体轴向对齐。
  19. 一种介入医疗导管，包括导管远端，其特征在于，所述导管远端设置有如权利要求12-18中任一项所述的压力传感器。
  20. 一种介入医疗导管，包括导管远端和电极，其特征在于，所述导管远端设置有如权利要求15所述的压力传感器，所述电极与所述压力传感器相连接，其中所述第一应变片相较于所述第二应变片更靠近所述电极。
PCT/CN2018/090483 2017-06-15 2018-06-08 应变片、压力传感器以及介入医疗导管 WO2018228290A1 (zh)

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