A pressure-aware electrophysiology catheter

Abstract

The application discloses a pressure-sensing electrophysiological catheter. The electrophysiological catheter comprises a catheter main body, a pressure sensor assembly capable of sensing pressure is arranged at the distal end of the catheter main body; wherein the pressure sensor assembly comprises a strain gauge capable of detecting pressure. The dimension of pressure sensing is increased, not only the magnitude of pressure can be sensed, but also the direction of pressure can be calculated.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of interventional surgery, in particular to a pressure sensing electrophysiology catheter. BACKGROUND

[0002] In the medical field, catheters are widely used in various diagnostic and therapeutic procedures, such as cardiac intervention, digestive endoscopy, etc. During the use of the catheter, the pressure sensing of the catheter head end is crucial. In order to accurately sense and control the pressure of the catheter head end, it is usually necessary to integrate a pressure sensor into the catheter. However, the existing pressure sensors have many problems in terms of size, sensitivity, stability, etc. At present, there are some pressure sensing catheters on the market, but they usually use complex mechanical structures or expensive sensor technology, which not only increases the manufacturing cost, but also may affect the accuracy of pressure sensing due to the installation precision and errors of the sensor.

[0003] Therefore, there is a need for a catheter that is simple in structure, low in manufacturing cost, and can accurately sense pressure. SUMMARY

[0004] In order to solve the problems existing in the prior art, the present application provides a pressure sensing electrophysiology catheter.

[0005] The specific technical scheme of the present application is as follows:

[0006] 1. A pressure sensing electrophysiology catheter, wherein the electrophysiology catheter comprises a catheter body, and a pressure sensor assembly capable of sensing pressure is arranged at the distal end of the catheter body;

[0007] The pressure sensor assembly can detect the magnitude and direction of the force it receives.

[0008] 2. The electrophysiology catheter according to item 1, wherein the pressure sensor assembly comprises a strain gauge assembly capable of detecting pressure; the strain gauge assembly comprises two or more strain gauges; preferably, the strain gauges are three.

[0009] 3. The electrophysiology catheter according to item 1 or 2, wherein the plurality of strain gauges are arranged circumferentially along the catheter body, and the centers of the plurality of strain gauges are located in the same radial section of the catheter body.

[0010] Preferably, the strain gauges are uniformly arranged circumferentially along the catheter body.

[0011] 4. The electrophysiology catheter according to any one of items 1 to 3, wherein the pressure sensor assembly further comprises a radial strain gauge; the radial strain gauge is one.

[0012] 5. The electrophysiological catheter according to any one of claims 1-4, wherein the strain gauges and the radial strain gauge form a half-bridge circuit capable of detecting changes in resistance of the strain gauges.

[0013] The plurality of strain gauges are connected in parallel, and all of the strain gauges are connected in series with the radial strain gauge.

[0014] 6. The electrophysiological catheter according to any one of claims 1-5, wherein a stainless steel body is arranged at a distal end of the catheter body, the pressure sensor assembly is arranged at a distal end of the stainless steel body, a softening hole is formed on the stainless steel body, and the softening hole is formed at a position close to the proximal end of the stainless steel body.

[0015] Preferably, the softening hole is formed by laser engraving.

[0016] 7. The electrophysiological catheter according to any one of claims 1-6, wherein a patch base material is arranged on the stainless steel body, and the pressure sensor assembly is bonded to the patch base material assembly.

[0017] 8. The electrophysiological catheter according to any one of claims 1-7, wherein the patch base material is fixedly connected to the stainless steel body, an outer cladding layer is arranged on the outer periphery of the stainless steel body, and the outer cladding layer is arranged on the outer periphery of the patch base material and fixes the patch base material to the stainless steel body.

[0018] Preferably, the outer cladding layer is a layer of high polymer material or a layer of silicone.

[0019] Further preferably, the outer cladding layer is a layer of silicone.

[0020] 9. The electrophysiological catheter according to claim 2,

[0021] When the electrophysiological catheter is subjected to pressure, the magnitude and direction of the pressure are calculated by obtaining the micro-strain values of the three strain gauges.

[0022] 10. The electrophysiological catheter according to claim 9,

[0023] The axial component of the pressure is calculated using Formula 1:

[0024]

[0025] ε1, ε2, and ε3 are the micro-strain values of the three strain gauges, respectively;

[0026] E is the elastic modulus of the strain gauge pressure sensor,

[0027] A is the cross-sectional area,

[0028] F axi is the axial component.

[0029] 11. The electrophysiology catheter of item 9,

[0030] The radial component of the pressure is calculated by calculating the magnitude and direction of the radial component.

[0031] 12. The electrophysiology catheter of item 9,

[0032] One of the three strain gauges is selected as the reference strain gauge, and the micro-strain value corresponding to the reference strain gauge is ε1; the micro-strain values corresponding to the other two strain gauges are ε2 and ε3, respectively;

[0033] The radial component of the pressure satisfies the following formulas 2-4:

[0034]

[0035] Where E is the elastic modulus of the material, A is the cross-sectional area, and I is the cross-sectional moment of inertia. The formula for calculating the cross-sectional moment of inertia of a circle is: F tan is the radial component, F axi is the axial component, H is the axial distance from the force point on the rigid body to the strain gauge pressure sensor, R is the radius of the cross-sectional circle, and θ is the central angle between the radial component F tan and the reference strain gauge at the center of the cross-sectional circle; H and R are known constants.

[0036] The magnitude and direction of the radial component F tan are calculated.

[0037] 13. The electrophysiology catheter of item 9, the radial component F tan is calculated according to the magnitude of the radial component F tan and the angle θ; and the magnitude and direction of the pressure are calculated in combination with the axial component F axi .

[0038] 14. A method for pressure sensing using the electrophysiology catheter of any one of items 1-13, comprising:

[0039] Using an electrophysiology catheter containing three strain gauges and a radial strain gauge to perform an interventional procedure;

[0040] The three strain gauges form a half-bridge circuit;

[0041] The three strain gauges are connected in parallel and in series with the radial strain gauge;

[0042] The micro-strain values of the three strain gauges when the electrophysiology catheter is subjected to pressure are measured;

[0043] The magnitude of the axial component of the pressure is calculated according to the micro-strain values of the strain gauges;

[0044] The radial component of the pressure is calculated according to the relationship between the micro-strain values of the three strain gauges and the pressure;

[0045] The pressure is calculated according to the radial component and the axial component of the pressure.

[0046] Advantages

[0047] The pressure sensing electrophysiological catheter of the present application has the following advantages:

[0048] 1. The integrated patch type pressure sensor technology is adopted, and the strain gauges of the three pressure sensors are pre-stuck to the patch substrate at specified angles and positions, and then the substrate is wrapped with silicone or other polymer materials to the specified position of the stainless steel body of the catheter. The advantage of this is that the sticking position and angle of the three pressure sensors can be more accurate, and the operation difficulty in actual production is also reduced.

[0049] 2. The silicone or other polymer material with good pressure conductivity and biocompatibility is selected to wrap the patch substrate and strain gauge silicone, which increases the protection of the pressure sensor and improves its service life and stability.

[0050] 3. The design of sticking three strain gauges at an angle of 120 degrees is adopted, which increases the dimension of pressure sensing, not only the size of the force can be sensed, but also the direction of the force can be calculated.

[0051] 4. The stainless steel body is engraved with a specified shape by laser etching technology, which reduces the rigidity of the stainless steel, so that the strain gauge can better respond to the change of force.

[0052] 5. A simple manufacturing process and equipment are adopted, which reduces the manufacturing cost and is conducive to large-scale production and application. BRIEF DESCRIPTION OF DRAWINGS

[0053] Figure 1 is a schematic diagram of the overall structure of the electrophysiological catheter of the present application.

[0054] In the figure, 1 is the catheter body; 2 is the stainless steel body; 3 is the strain gauge; 4 is the softening hole; 5 is the patch substrate; 6 is the head electrode. DETAILED DESCRIPTION

[0055] The present application will be described in detail below. Although specific embodiments of the present application are shown, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. On the contrary, these embodiments are provided to enable a more thorough understanding of the present application and to fully convey the scope of the present application to those skilled in the art.

[0056] It is to be noted that some terms are used in the specification and claims herein for the purpose of reference. Those skilled in the art will appreciate that the same element can be referenced using a different name. The specification and claims are not intended to be limited to the elements illustrated in the figures, which are intended to illustrate concepts of the application. The word "comprising" or "including" as used in the specification and claims when used in reference to a list of elements includes the elements listed, but not excluding additional elements. The description of the preferred embodiments is intended to be illustrative, and not to limit the scope of the application. The scope of the application is defined by the following claims.

[0057] Reference Figure 1 The present application provides a pressure sensing electrophysiological catheter. A pressure sensing electrophysiological catheter, wherein the electrophysiological catheter comprises a catheter body 1, and a pressure sensor assembly capable of sensing pressure is arranged at the distal end of the catheter body 1.

[0058] In the field of interventional medicine, the end close to the operator is defined as "proximal end", and the end away from the operator is defined as "distal end". For a long object, the direction parallel to the extension direction of its length is defined as "axial direction"; for an object with a circular cross section, the direction around the axial direction is defined as "circumferential direction". For a cylindrical object, its extension direction is defined as "axial direction", and the radial direction of the circular cross section is defined as "radial direction".

[0059] When the catheter body 1 moves inside the human body, the catheter body 1 will be in contact with the tissue, and thus the catheter body 1 will be subjected to the abutting force of the tissue. The pressure sensor assembly located at the distal end of the catheter body 1 is used to detect the abutting force of the catheter body at the distal end. The abutting force of the human tissue on the catheter body 1 detected by the pressure sensor assembly includes the magnitude and direction of the force.

[0060] When the operator knows the magnitude and direction of the abutting force through the pressure sensor assembly, the operator can know the situation of the catheter body 1, and thus the probability of causing damage to the human body during the operation can be greatly reduced. Further, the operator can prevent the catheter body 1 from penetrating deeper into the human body before the catheter body 1 will injure the tissue when the catheter body is delivered deeper into the human body according to the magnitude and direction of the abutting force. This not only reduces the damage of the catheter body 1 to the tissue, but also helps to deliver the catheter body 1 to the target position in the human body smoothly.

[0061] The pressure sensor assembly comprises a head electrode 6 arranged at the position of the head of the catheter body 1 at the distal end; the head electrode 6 is located at the distal end of the catheter body 1; when the catheter body 1 advances in the human body, the head electrode 6 is located at the front end of the catheter body 1, the head electrode 6 is used to contact the human tissue and perceive the pressure received by the catheter body 1.

[0062] The pressure sensor assembly comprises a strain gauge assembly capable of detecting pressure, and the strain gauge assembly comprises two or more strain gauges; preferably, the strain gauges are arranged in three.

[0063] In the present application, the strain gauge type pressure sensor is used to detect the abutting force received by the catheter body 1.

[0064] Since the catheter body 1 needs to enter the human body through the blood vessels of the human body, the size of the catheter body 1 is limited, and the strain gauges 3 can be kept at a small size while ensuring sufficient accuracy. Therefore, in the present application, the strain gauges 3 are installed at the distal end of the catheter body 1.

[0065] The number of strain gauges 3 is two or more.

[0066] The strain gauges 3 are used to detect the abutting force, and when the tissue exerts an abutting force on the catheter body 1, the strain gauges 3 can detect the pressure at their positions.

[0067] Since the working principle of the strain gauges 3 is that the strain gauges 3 deform under force, and the size of the deformation is used to measure the size of the force, in the present application, multiple strain gauges 3 are used to detect the forces at different positions of the circumferential periphery of the catheter body 1, and then the abutting force is inversely deduced according to the differences in the components of the abutting force at different positions. Thus, the size and direction of the abutting force are determined. Therefore, the strain gauges 3 are arranged in at least two.

[0068] Specifically, the number of strain gauges 3 is 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15.

[0069] Preferably, the strain gauges 3 are arranged in three.

[0070] In the present application, since the position of the catheter body 1 changes at any time when it penetrates into the human body, the abutting force received by the catheter body 1 is also uncertain. Therefore, the force received by the catheter body 1 is more often a force in three-dimensional space.

[0071] In determining and calculating the size and direction of the abutting force, an equation can be derived from the correlation between the component forces of the abutting force in the three directions of the xyz axis in the three-dimensional space and the abutting force. Therefore, the application sets three strain gauges 3, lists the equation by the different position data detected by the three strain gauges 3, and then calculates the component forces of the abutting force to indirectly calculate the abutting force. Or the size and direction of the abutting force can be directly calculated.

[0072] The plurality of strain gauges 3 are arranged along the circumference of the catheter body 1, and the centers of the plurality of strain gauges 3 are located in the same radial section of the catheter body 1.

[0073] Preferably, the strain gauges 3 are uniformly arranged along the circumference of the catheter body 1.

[0074] The elastic deformation of the catheter body 1 in the axial direction is minimal when it is deeply inserted into the human body, so the catheter body 1 is a rigid body in the axial direction, and the component force of the catheter body 1 in the axial direction is equal everywhere. Therefore, in order to reduce the calculation intensity of calculating the abutting force according to the strain gauges 3, the strain gauges 3 are arranged on the same section, which can eliminate the axial distance component of the pressure sensor, and thus make the calculation of the abutting force more convenient.

[0075] Because of the variability of the force on the catheter body 1 during insertion into the human body, in order to enable the strain gauges 3 to detect more limited abutting forces, the strain gauges 3 are uniformly arranged along the circumference of the catheter body 1 to enable more force situations to be dealt with.

[0076] The pressure sensor assembly further comprises a radial strain gauge; the radial strain gauge is provided with one.

[0077] The strain gauges 3 and the radial strain gauge form a half-bridge circuit capable of detecting the resistance change of the strain gauges 3.

[0078] The plurality of strain gauges 3 are connected in parallel, and all the strain gauges 3 are connected in series with the radial strain gauge.

[0079] The radial strain gauge and the strain gauges 3 jointly form a half-bridge circuit or a full-bridge circuit, preferably a half-bridge circuit; for temperature compensation of the strain gauges 3, to improve the detection accuracy of the strain gauges 3.

[0080] In one specific embodiment, a half-bridge circuit is formed between each strain gauge 3 and the radial strain gauge; the half-bridge circuit can respectively compensate for the temperature of each strain gauge 3, thereby reducing the error caused by temperature during detection of the strain gauges 3, and improving the accuracy of the strain gauges in detecting stress. And improve the accuracy of the electrophysiological catheter in sensing pressure.

[0081] A stainless steel body 2 is arranged at a distal end of the catheter body 1, and the pressure sensor assembly is arranged at a distal end of the stainless steel body 2.

[0082] The stainless steel body 2 is used to bear the pressure sensor; the distal end of the catheter body 1 is connected with the stainless steel body 2, and then the pressure sensor assembly is installed at the distal end of the stainless steel body 2. The stainless steel body 2 is used to connect the pressure sensor assembly and the catheter body 1.

[0083] A softening hole 4 is arranged on the stainless steel body 2; the softening hole 4 is arranged at a position close to the proximal end of the stainless steel body 2.

[0084] Preferably, the softening hole 4 is formed by laser engraving.

[0085] The stainless steel body 2 is a hollow tubular structure. The softening hole 4 is a through hole on the stainless steel body 2. Therefore, under the action of the softening hole 4, the stainless steel body 2 ensures that the stainless steel body 2 has sufficient use strength, while greatly increasing the elasticity of the stainless steel body 2. Therefore, when the pressure sensor assembly is subjected to an abutting force, the stainless steel body 2 can be deformed, so that the pressure sensor has a buffer area. The trend that the abutting force gradually increases as the catheter body 1 penetrates is alleviated, thereby allowing the operator to control the size of the abutting force for a longer time.

[0086] On the other hand, the stainless steel body 2 with the softening hole 4 can also provide elastic deformation, so that when the force of the catheter body 1 and the pressure sensor assembly contacting the tissue is too large, the axial force of the catheter body 1 and the pressure sensor assembly can be offset, thereby reducing the damage of the tissue caused by the puncture.

[0087] A patch substrate 5 is arranged on the outer surface of the stainless steel body 2, and the pressure sensor assembly is bonded to the patch substrate 5.

[0088] The patch substrate 5 is the substrate of the strain gauge 3. The patch substrate 5 can be bonded to the stainless steel body 2.

[0089] The strain gauge 3 is bonded to the patch substrate 5.

[0090] Specifically, in the present application, the patch substrate 5 is a layer of substrate material attached to the outer surface of the stainless steel body 2.

[0091] During installation, three strain gauges 3 are first installed or bonded to the patch substrate 5; and then the patch substrate 5 is bonded to the outer circumferential surface of the stainless steel body 2.

[0092] The size of the patch base material 5 is matched with the outer circumferential size of the stainless steel body 2. The patch base material 5 can fix the strain gauges 3 on the stainless steel body 2; and the patch base material 5 with a proper size can reduce the influence of the patch base material 5 on the stainless steel body 2 and the strain gauges 3, for example, the displacement of the strain gauges 3 caused by too much lamination of the patch base material 5, thereby increasing the positioning accuracy of the strain gauges 3.

[0093] When the strain gauges 3 are installed on the stainless steel body 2, since the stainless steel body 2 is in a cylindrical shape, the strain gauges 3 need to be aligned not only in the axial direction of the stainless steel body 2, but also uniformly arranged in the circumferential direction, that is, the distance between any two strain gauges 3 is equal. Therefore, it is difficult to position the strain gauges 3 when they are fixed on the stainless steel body 2, which reduces the pressure detection accuracy of the strain gauges 3, reduces the yield of the electrophysiological catheter, and increases the manufacturing cost of the electrophysiological catheter.

[0094] Therefore, when the strain gauges 3 are installed on the stainless steel body 2, the strain gauges 3 are first fixed on the patch base material 5. The patch base material 5 is a layer structure, so that the strain gauges 3 are more easily and accurately positioned on the patch base material 5. Compared with the positioning of the strain gauges 3 on the cylindrical surface directly on the plane, the patch base material 5 is more helpful to improve the yield of the electrophysiological catheter and reduce the manufacturing cost of the electrophysiological catheter. After the strain gauges 3 are fixed on the patch base material 5, the patch base material 5 is directly attached to the predetermined position on the stainless steel body 2. Since the strain gauges 3 have been accurately positioned on the patch base material 5, the installation of the strain gauges 3 is realized after the patch base material 5 is attached to the stainless steel body 2.

[0095] The patch base material 5 is used to fix the strain gauges 3 on the stainless steel body 2, so that the strain gauges 3 can detect the abutting force.

[0096] The patch base material 5 is fixedly connected with the stainless steel body 2; an outer wrapping layer is arranged on the outer periphery of the stainless steel body 2; the outer wrapping layer is sleeved on the outer periphery of the patch base material 5, and the patch base material 5 is fixed on the stainless steel body 2;

[0097] Preferably, the outer wrapping layer is a high polymer material layer or a silica gel layer.

[0098] Further preferably, the outer wrapping layer is a silica gel layer.

[0099] The outer wrapping layer wraps the patch base material 5, the strain gauges 3 and the stainless steel body 2. The outer wrapping layer is made of a material with high insulation and tightness, which can isolate the internal structure from the external air or the liquid in the human body.

[0100] Meanwhile, the softening hole 4 is arranged in the stainless steel body 2, and the stainless steel body 2 is wrapped by an outer layer, so that the gas or liquid in the stainless steel body 2 is prevented from entering the catheter body 1.

[0101] When the electrophysiological catheter is subjected to pressure, the magnitude and direction of the pressure are calculated by obtaining the micro-strain values of the three strain gauges 3.

[0102] The axial component of the pressure is calculated by using formula 1:

[0103]

[0104] ε1, ε2, and ε3 are the micro-strain values of the three strain gauges, respectively;

[0105] E is the elastic modulus,

[0106] A is the cross-sectional area,

[0107] F axi is the axial component.

[0108] When the electrophysiological catheter is inserted into the human body, the pressure on the electrophysiological catheter is the abutting force.

[0109] The radial component of the pressure is calculated by calculating the magnitude and direction of the radial component, respectively.

[0110] One of the strain gauges 3 is selected as a reference strain gauge, and the micro-strain value corresponding to the reference strain gauge is ε1; the micro-strain values corresponding to the other two strain gauges 3 are ε2 and ε3, respectively;

[0111] The radial component of the pressure satisfies the following formulas 2-4:

[0112]

[0113] wherein E is the elastic modulus of the material, A is the cross-sectional area, and I is the cross-sectional moment of inertia, and the cross-sectional moment of inertia of a circle is calculated by the following formula: F tan is the radial component, and F axi is the axial component, H is the axial distance from the force point on the rigid body to the strain gauge, and R is the radius of the cross-sectional circle; the angle θ is the central angle corresponding to the reference strain gauge at the center of the cross-sectional circle; and H and R are known constants. tan

[0114] In the present application, H is the distance between the force point of the strain gauge 3 and the head electrode 6.

[0115] The magnitude and direction of the radial component F tan are calculated by combining the three formulas 2-4.

[0116] ​According to the magnitude of the radial force F tan and the angle θ, the radial force F tan is calculated; and in combination with the axial force F axi , the magnitude and direction of the pressure are calculated.

[0117] The display assembly is connected to the electrophysiological catheter, and the display assembly displays the calculated stress results according to the detection of the pressure sensor assembly; and then the display assembly displays the magnitude and direction of the pressure on the electrophysiological catheter, so that the user can directly view the stress on the electrophysiological catheter or the catheter body 1 through the display assembly.

[0118] A method for sensing pressure by using the electrophysiological catheter described above, comprising:

[0119] Using the electrophysiological catheter containing three strain gauges and one radial strain gauge to perform an interventional operation;

[0120] The strain gauges can sense pressure; when the electrophysiological catheter is subjected to pressure, the strain gauges can generate an electrical signal, and the magnitude of the force on the strain gauge can be sensed according to the strength of the electrical signal. Then, according to the positions of the strain gauges and the magnitudes of the forces sensed by the strain gauges, the magnitude and direction of the pressure are calculated.

[0121] The three strain gauges form a half-bridge circuit;

[0122] The three strain gauges are connected in parallel and connected in series with the radial strain gauge;

[0123] The half-bridge circuit and the full-bridge circuit are used for temperature compensation of the strain gauges, so as to reduce the measurement error caused by thermal expansion and contraction of the strain gauges during use. The measurement accuracy of the strain gauges for pressure is improved.

[0124] The micro-strain values of the three strain gauges when the electrophysiological catheter is subjected to pressure are measured;

[0125] The three strain gauges are evenly arranged on the electrophysiological catheter, so that when the electrophysiological catheter is subjected to pressure, the forces of the three strain gauges at different positions will change with the direction of the pressure.

[0126] Therefore, the magnitude of the force of the pressure on the strain gauge position can be calculated according to the micro-strain values of the strain gauges, and then the magnitude and direction of the pressure are calculated according to the magnitudes of the forces of the three strain gauges in three directions and the positional relationship between the three strain gauges and the stress point of the pressure.

[0127] The magnitude of the axial force of the pressure is calculated according to the micro-strain values of the strain gauges;

[0128] The radial force of the pressure is calculated according to the relationship between the micro-strain values of the three radial strain gauges and the pressure.

[0129] In calculating the pressure, the axial and radial components of the pressure need to be calculated respectively, and then the resultant force is calculated, and then the pressure is calculated.

[0130] In calculating the axial component of the pressure, the formula 1 is used to calculate:

[0131]

[0132] ε1, ε2, ε3 are the micro-strain values corresponding to the three strain gauges respectively;

[0133] E is the elastic modulus,

[0134] A is the cross-sectional area,

[0135] F axi is the axial component.

[0136] In calculating the radial component of the pressure, the formula 2-4 are used to calculate the size and direction of the radial component.

[0137]

[0138]

[0139] Wherein, E is the elastic modulus of the material, A is the cross-sectional area, I is the cross-sectional moment of inertia, and the cross-sectional moment of inertia of a circle is calculated by the formula: F tan is the radial component, F axi is the axial component, H is the axial distance from the force point on the rigid body to the strain gauge, R is the radius of the cross-sectional circle, and the angle θ is the central angle corresponding to the radial component F tan and the reference strain gauge at the center of the cross-sectional circle; H and R are both known constants.

[0140] The pressure is calculated according to the radial and axial components of the pressure.

[0141] In summary, the present application provides a pressure-sensing electrophysiological catheter, which is provided with a pressure sensor assembly at the head end of the electrophysiological catheter for sensing the pressure received by the catheter body 1. When the electrophysiological catheter is used to penetrate into the human body, the head electrode 6 at the front end of the electrophysiological catheter will receive pressure, and the strain gauge 3 will sense the pressure received by the head electrode 6, and then the strain gauge 3 will deform; and different sizes of currents are generated according to different positions of the strain gauge 3, and then the size and direction of the axial and radial components of the pressure on the electrophysiological catheter are calculated according to the current size on the strain gauge 3 and the position of the strain gauge 3. Finally, the size and direction of the pressure are calculated according to the axial and radial components, and finally displayed in the display assembly. The user can watch the results in the display assembly.

[0142] The embodiments are only illustrative of the present application, and are not intended to limit the present application. Those skilled in the art can make modifications to the embodiments according to the present application without creative contribution, as long as the modifications are within the scope of the present application.

Claims

1. A pressure-sensing electrophysiology catheter, wherein, The electrophysiological catheter comprises a catheter body, a pressure sensor assembly capable of sensing pressure is arranged at the distal end of the catheter body; The pressure sensor assembly can detect the magnitude and direction of the force it receives; The pressure sensor assembly comprises a strain gauge assembly capable of detecting pressure; the strain gauge assembly comprises two or more strain gauges; the strain gauge is provided with three; The plurality of strain gauges are arranged circumferentially along the catheter body, and the centers of the plurality of strain gauges are located in the same radial section of the catheter body; The strain gauges are uniformly arranged circumferentially along the catheter body; The pressure sensor assembly further comprises a radial strain gauge; the radial strain gauge is provided with one; The strain gauges and the radial strain gauge form a half-bridge circuit capable of detecting changes in strain gauge resistance; The plurality of strain gauges are connected in parallel, and all the strain gauges are connected in series with the radial strain gauge; The axial component of the pressure is obtained using Formula 1: ε1, ε2, ε3 are the micro-strain values corresponding to the three strain gauge pressure sensors, respectively; E is the elastic modulus of the strain gauge pressure sensor, A is the cross-sectional area, F axi is the axial force component; The radial component of the pressure is calculated by calculating the magnitude and direction of the radial component, respectively; One of the strain gauge pressure sensors is selected as a reference strain gauge, and the micro-strain value corresponding to the reference strain gauge is ε1; the micro-strain values corresponding to the other two strain gauge pressure sensors are ε2 and ε3, respectively; The radial component of the pressure satisfies the following Formulas 2-4: Wherein, E is the elastic modulus of the material, A is the cross-sectional area, I is the cross-sectional moment of inertia, the cross-sectional moment of inertia of the circle is calculated by the formula: F tan is the radial component force, F axi is the axial component force, H is the axial distance from the force point on the rigid body to the strain gauge pressure sensor, R is the radius of the cross-section circle; The angle θ is the corresponding central angle of the radial component force F tan and the reference strain gauge at the center of the cross-section circle; H and R are both known constants; The magnitude and direction of the radial force F tan is calculated. The radial force F tan is calculated from the magnitude of the radial component F tan and the angle θ, and the magnitude and direction of the pressure are calculated in combination with the axial force F axi .

2. The electrophysiology catheter of claim 1, wherein, A stainless steel body is arranged at the distal end of the catheter body, and the pressure sensor assembly is arranged at the distal end of the stainless steel body; a softening hole is formed in the stainless steel body; the softening hole is formed in the stainless steel body near the proximal end.

3. The electrophysiology catheter of claim 2, wherein, The softening hole is formed by laser engraving.

4. The electrophysiology catheter of claim 3, wherein, A patch substrate is arranged on the stainless steel body, and the pressure sensor assembly is bonded to the patch substrate assembly.

5. The electrophysiology catheter of claim 4, wherein, The patch substrate is fixedly connected to the stainless steel body; an outer cladding layer is arranged on the outer periphery of the stainless steel body; the outer cladding layer is arranged on the outer periphery of the patch substrate and fixes the patch substrate to the stainless steel body.

6. The electrophysiology catheter of claim 5, wherein, The outer cladding layer is a layer of high molecular material or a layer of silicone.

7. The electrophysiology catheter of claim 6, wherein, The outer cladding layer is a layer of silicone.

8. The electrophysiology catheter of claim 7, wherein, When the electrophysiological catheter is subjected to pressure, the magnitude and direction of the pressure are calculated by obtaining the micro-strain values of the three strain gauges.

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