A handheld pressure wire system

Abstract

The application relates to the technical field of medical devices, and particularly discloses a handheld pressure guide wire system, which aims to solve the technical contradiction between high-fidelity physiological signal transmission of the pressure guide wire and operation flexibility, rotation freedom and torque feedback accuracy in a coronary intervention operation. The system comprises a pressure guide wire and a handheld operator, the operator is provided with a liquid metal rotary transmission mechanism and a signal interference suppression unit, is used for high-fidelity transmission of physiological signals and differential amplification, dynamic noise suppression and multi-stage filtering. The scheme realizes high-fidelity and stable transmission of microvolt physiological signals, endows the guide wire with infinite rotation freedom, accurate torque feedback and smooth operation feeling, and significantly improves the operation safety, efficiency and accuracy and the portability of the equipment.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a handheld pressure guide wire system. BACKGROUND

[0002] In cardiovascular intervention, physiological assessment of coronary artery stenosis is an important basis for guiding percutaneous coronary intervention (PCI) decision. Among them, fractional flow reserve (FFR) technology as a key progress has become an internationally recognized standard for PCI operation guidance. This technology uses an interventional pressure guide wire or pressure microcatheter system to measure the average pressure of the distal stenosis (Pd) and the average pressure of the coronary artery opening (Pa), and then calculates the pressure gradient ratio to quantitatively assess the actual impact of stenosis on hemodynamics. FFR technology can not only accurately determine whether the coronary artery causes functional ischemia, but also accurately locate the ischemic lesion, providing a key basis for stent implantation decision, and significantly improving patient prognosis.

[0003] With the popularization and in-depth clinical application of FFR technology, a guide wire structure with multi-channel pressure monitoring capability has appeared. This type of guide wire integrates multiple miniature pressure sensor units, enabling multi-point continuous detection of intravascular blood pressure, thereby obtaining more comprehensive physiological information. To ensure that the weak physiological signals collected by each sensor can be reliably transmitted to the external host computer, the existing technology generally lays a wire or conductive film inside the guide wire, connects the sensor to the proximal end of the external electrical connection point, and connects to the external host computer through a fixed connection method to ensure the stability of signal transmission.

[0004] However, when the proximal end of the pressure guide wire is fixed on the connector to maintain electrical connection, it will be subjected to additional mechanical resistance and reverse torque from the fixed end during pushing and rotating operations, making it difficult for the operator to accurately judge the real resistance and torque changes encountered by the guide wire in the blood vessel through hand feeling. Especially during fine rotation operation, the proximal end constraint seriously interferes with the continuity and smoothness of the operation, which may prolong the operation time and increase the risk of operation.

[0005] Therefore, it is necessary to provide a handheld pressure guide wire system to solve the above technical problems. SUMMARY

[0006] The present application overcomes the shortcomings of the prior art, provides a handheld pressure guide wire system that maximally reduces the additional mechanical resistance experienced by the guide wire during axial pushing, retraction and radial rotation while ensuring high-fidelity and low-noise transmission of multi-channel physiological signals. In addition, the present application realizes unlimited rotational freedom of the guide wire and accurately and clearly feeds back the real torque and resistance encountered by the guide wire in the blood vessel to the doctor, thereby significantly improving the safety, accuracy and efficiency of the intervention operation.

[0007] To achieve the above object, the technical scheme adopted by the present application is as follows: a handheld pressure guide wire system comprises:

[0008] a pressure guide wire having a plurality of pressure sensing units, signals of the pressure sensing units being output via a plurality of signal rings and a common connection ring provided at a proximal end of the pressure guide wire; and

[0009] a handheld controller comprising a housing, a rotary transmission mechanism being provided inside the housing, the rotary transmission mechanism comprising:

[0010] a fixing mechanism having a plurality of clamping petals for mechanically clamping the pressure guide wire, pins on inner walls of the clamping petals being electrically connected to the signal rings and the common connection ring of the pressure guide wire;

[0011] a rotor being rotatably provided on the housing through a bearing assembly, the rotor being electrically connected to an electrical contact area on an outer wall of the clamping petals through rotor pins; and

[0012] a stator being fixedly installed in the housing and opposite to the rotor, a plurality of annular grooves being formed on a surface of the stator, a plurality of annular protrusions being provided on a surface of the rotor and matching the annular grooves, a plurality of fluid gaps being formed between the annular protrusions and the annular grooves and filled with liquid metal medium, and stator pins being provided on a side of the stator of the fluid gaps, the stator pins being connected to a signal output module through an internal circuit;

[0013] wherein the handheld controller further comprises:

[0014] a signal output module connected to the stator pins for receiving and pre-processing physiological signals transmitted by the liquid metal medium; and

[0015] a processing module connected to the signal output module for analyzing and processing the pre-processed physiological signals to calculate a fractional flow reserve (FFR) and / or perform pressure difference analysis.

[0016] In a preferred embodiment of the present application, the fixing mechanism is composed of three or four clamping petal rings, main bodies of the clamping petals are made of medical-grade insulating materials, clamping petal pins are embedded in the main bodies of the clamping petals and exposed on inner wall surfaces and outer wall surfaces of the clamping petals in the form of arc-shaped conductive sheets.

[0017] In a preferred embodiment of the present application, outer surfaces of the clamping petals are provided with external threads and are conical surfaces, an inner wall of the rotor is provided with internal threads engaging with the external threads and is a conical surface matching the outer surfaces of the clamping petals; by rotating the rotor, the clamping petal group is driven by the thread pair to generate axial displacement, and then the clamping petals are forced to radially contract to tightly hold the pressure guide wire through the conical surface cooperation.

[0018] In a preferred embodiment of the present application, the front end of the shell is provided with a guide wire inlet, and the outer surface of the guide wire inlet is connected with the shell through a gap or a bearing, so that the guide wire inlet can rotate around the axial direction of the shell relative to the shell.

[0019] In a preferred embodiment of the present application, one end of the plurality of clamping petals towards the guide wire inlet is an integral structure, and is movably connected with the guide wire inlet through a sliding key groove or a spline, so that the clamping petal group can slide in a small range along the axial direction of the pressure guide wire, and cannot rotate independently around the axial line thereof.

[0020] In a preferred embodiment of the present application, the width of the fluid gap is 15-30 μm, and the number of the fluid gaps is consistent with the total number of the signal ring and the common connection ring arranged at the proximal end of the pressure guide wire.

[0021] In a preferred embodiment of the present application, the liquid metal medium is a liquid gallium-based eutectic alloy that remains liquid at room temperature, and its composition is: gallium 66-70%, indium 19-21%, and tin 11-13% by weight percentage.

[0022] In a preferred embodiment of the present application, the stator is provided with a labyrinth seal ring on each side wall of the annular groove, and a micron-level non-contact cooperation is formed between the labyrinth seal ring and the annular protruding structure of the rotor.

[0023] In a preferred embodiment of the present application, the signal output module comprises:

[0024] A differential amplification unit is used for directly receiving and amplifying the differential physiological signal from the stator pin;

[0025] A noise suppression unit is used for digitizing the amplified signal, and identifying and suppressing the dynamic noise in the digitized signal based on an adaptive algorithm;

[0026] A multi-stage filtering unit is used for frequency domain filtering of the noise-suppressed signal, and the filtering link thereof comprises a low-pass filter, a notch filter and a high-pass filter arranged in sequence.

[0027] In a preferred embodiment of the present application, the processing module comprises a data acquisition unit, a signal calibration unit, an FFR calculation unit, a differential pressure analysis unit and a data storage unit.

[0028] In a preferred embodiment of the present application, the handheld controller further comprises a display module arranged on the shell; the display module is used for displaying the physiological parameter information output by the processing module in real time.

[0029] The present application solves the defects in the background art and has the following advantages:

[0030] (1) The present application provides a handheld pressure guide wire system. Through the design of liquid metal medium in the rotary transmission mechanism, multiple fluid gaps filled with specific gallium-based alloy are formed between the stator and the rotor, which meets the characteristics of multi-point pressure monitoring and multi-signal transmission line of the pressure guide wire. The liquid metal has ultra-low viscosity and high electrical conductivity, which makes the rotor almost produce no mechanical resistance when rotating infinitely, and provides a continuous and wear-free stable conductive path for multi-channel physiological signals. It realizes the infinite rotation freedom of the pressure guide wire in operation, avoids the cable winding and operation interruption caused by the fixed multi-signal line, and solves the problems of limited rotation and torque feedback distortion of the proximal end of the guide wire in the prior art. The present application enables the doctor to rotate smoothly like operating a common guide wire, significantly improves the smoothness of navigation in complex vascular paths and the efficiency of surgery, and ensures the synchronous transmission of multi-channel signals without distortion.

[0031] (2) The present application directly processes the micro-volt multi-channel physiological signals transmitted from the liquid metal medium through differential amplification, adaptive noise suppression and multi-stage filtering units in the signal output module. The differential amplification unit has high input impedance and high common-mode rejection ratio, which effectively suppresses common-mode noise; the noise suppression unit dynamically identifies and eliminates transient fluctuations caused by rotation based on algorithm; and the multi-stage filter further removes power frequency interference and baseline drift. This directly ensures the high-fidelity and low-noise transmission of weak physiological signals, making the FFR calculation and pressure difference analysis results more accurate and reliable. Compared with the signal distortion caused by contact resistance fluctuation and electromagnetic interference in the traditional fixed connection method, the present system still maintains high signal-to-noise ratio under dynamic rotation. Further, the high-purity signal provides more reliable physiological evaluation basis for clinical practice, improving the accuracy and safety of surgical decision-making.

[0032] (3) The present application integrates the processing module and the display module into the handheld controller, and combines the infinite rotation characteristics of the rotary transmission mechanism to realize the portability of the device and the integration of the operation. The rotary transmission mechanism enables the doctor to rotate and push the guide wire without limitation, while the display module displays the pressure waveform and FFR value in real time, providing immediate visual feedback. The direct effect is to reduce the dependence on external large host computers, simplify the surgical preparation process, and improve the space utilization efficiency of the operating room. Compared with the inconvenience caused by the need to connect cumbersome equipment in the prior art, the present application greatly improves the convenience, flexibility of clinical application and space efficiency of the operating room. BRIEF DESCRIPTION OF DRAWINGS

[0033] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the accompanying drawings needed to be used in the embodiments or prior art description will be briefly introduced. Obviously, the accompanying drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without any creative effort.

[0034] Figure 1 is a schematic diagram of the overall structure of a handheld pressure guide wire system of the present application;

[0035] Figure 2 is a schematic diagram of a rotary transmission mechanism of the present application;

[0036] Figure 3 is an exploded view of the rotary transmission mechanism of the present application.

[0037] In the figure: 100, pressure guide wire; 110, pressure sensing unit; 120, signal ring; 130, common ground connection ring; 200, handheld controller; 210, housing; 211, guide wire inlet; 300, rotary transmission mechanism; 310, fixing mechanism; 311, clamping part; 320, rotor; 330, stator; 340, fluid gap; 400, signal output module; 500, display module. DETAILED DESCRIPTION

[0038] In a conventional coronary intervention operation, the core of guide wire operation is the highly synchronized mechanical feedback and control between the doctor's hand and the guide wire tip. The key operating elements include: first, smooth axial pushing, which makes the guide wire smoothly advance in the blood vessel; second, free radial rotation, which accurately guides the head end by rotating the proximal end of the guide wire, realizing navigation in complex anatomical structures; third, efficient torque transmission, that is, the hand rotation action should be nearly 1:1 transmitted to the guide wire head end, and when encountering resistance, it can be clearly fed back to the doctor's hand, forming the key "hand feeling". This hand feeling is an important basis for the doctor to judge the blood vessel situation, avoid risks and precise operation.

[0039] However, when the proximal end of the pressure guide wire is fixed to the connector to maintain electrical connection, its core mechanical operation performance is severely restricted, which is specifically manifested as:

[0040] Limited rotation freedom: the doctor cannot achieve continuous and unlimited rotation operation. Usually after rotating several turns, the connecting cable will be wound and tightened, forcing the doctor to reverse the rotation. This interrupted operation not only affects the smoothness, but also may cause the guide wire to be unable to effectively pass through the stenosis or tortuous lesion, prolonging the operation time and increasing the risk.

[0041] Torque transmission and feedback distortion: The proximal fixed point will absorb or offset the torque generated by the resistance encountered by the guide wire in the blood vessel, making it difficult for the doctor to perceive the true state of the guide wire head. The loss of touch is like "blind man touching the elephant", increasing the risk of blood vessel damage, perforation or guide wire failure to reach the site, affecting the safety and accuracy of the operation.

[0042] Axial pushing is blocked: The fixed connection point generates reverse friction resistance when pushing or retracting the guide wire, causing the action to be sluggish and not coherent, weakening the doctor's ability to fine-tune the guide wire position and increasing the difficulty of the operation.

[0043] As can be seen, the proximal fixation method adopted by the existing pressure guide wire to ensure the stability of physiological signal transmission essentially sacrifices the crucial manipulation performance of the interventional guide wire, forming an inherent contradiction between high-fidelity physiological signal transmission and instrument operation flexibility.

[0044] To solve the above problems, the applicant proposes a handheld pressure guide wire system to overcome the inherent technical contradiction between high-fidelity physiological signal transmission and extreme instrument operation flexibility in the existing interventional invasive pressure guide wire. Through precise mechanical structure, advanced material science application and innovative electrical design, the system ensures the stability of microvolt-level physiological signal transmission while giving the pressure guide wire unlimited rotational freedom and precise torque feedback.

[0045] The technical solutions in the embodiments of the present application will be described clearly and completely in the following description of the embodiments of the present application with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor are within the scope of protection of the present application.

[0046] In the following description, many specific details are set forth in order to provide a thorough understanding of the present application, but the present application can also be implemented in other ways different from those described herein, therefore, the scope of protection of the present application is not limited by the specific embodiments disclosed below.

[0047] Figure 1 The overall structure schematic diagram of a handheld pressure guide wire system of the embodiment is shown, which includes: a pressure guide wire 100 and a handheld controller 200; wherein the handheld controller 200 further includes: a shell 210, a rotary transmission mechanism 300, a signal output module 400, a processing module and a display module 500. The overall pressure guide wire system focuses on optimizing the guide wire control touch, signal transmission quality and overall electromagnetic compatibility of the system around the operation needs of medical personnel in coronary intervention surgery.

[0048] The pressure guide wire 100 of the present embodiment has a distal end and a proximal end, wherein the distal end region is provided with a plurality of pressure sensing units 110 distributed along the axial direction at intervals. The pressure sensing units 110 are micro semiconductor piezoresistive sensors, whose size is controlled within 0.1mm-0.3mm, and are directly integrated on the core or the outer surface of the guide wire by micro-electro-mechanical system (MEMS) technology. Each pressure sensing unit 110 includes upper and lower electrodes, wherein the upper electrode is connected as a signal line by an independent conductive strip or wire, for transmitting the pressure signal collected by the pressure sensing unit 110; and the lower electrode is connected as a common ground electrode by a common conductive strip or directly connected with the metal core wire of the pressure guide wire 1 to ensure the uniformity of the potential reference.

[0049] Further, the signal lines and the ground lines are routed from the distal end region to the proximal end region of the pressure guide wire 100 along the axial direction. In order to ensure that these weak physiological signals are not lost and disturbed during transmission, these conductive lines / bands are insulated and packaged by multi-layer polyimide (Polyimide) or parylene C (Parylene C) on the guide wire. In the proximal end region of the pressure guide wire 100, the outer surface of the insulating layer is accurately spaced along the axial direction, and a plurality of signal rings 120 are provided thereon, which are made of high-purity platinum-iridium alloy or gold-plated nickel-titanium alloy, with a ring width of 3-10mm and a thickness of 0.2-1mm. The signal rings 120 are deinsulated at the corresponding signal line and signal ring 120 connection positions, and the signal line and the signal ring 120 are electrically connected, while the other signal lines remain completely insulated and isolated, thereby avoiding signal crosstalk. Further, in the proximal end region of the pressure guide wire 100, the common ground connection ring 130 for common ground connection is exposed by laser ablation or mechanical deinsulation treatment, and the common ground connection ring 130 is directly connected with the common conductive strip or the metal core wire, forming a stable common ground terminal.

[0050] The shell 210 of the handheld controller 200 of the present embodiment constitutes the core support component of the overall external structure of the handheld pressure guidewire system, which is ergonomically designed to ensure that medical personnel can hold it comfortably and stably during long-term surgical operations. The shell 210 is made of high-strength, sterilizable, and biocompatible engineering plastics such as medical-grade polycarbonate (PC) or polyphenylene sulfide (PPS), and its internal surface is coated with a 0.1mm-0.3mm-thick nickel-copper alloy conductive coating, or the shell 210 itself is integrally formed from a conductive polymer-based composite material, thereby forming an overall electromagnetic shielding cavity. The shielding cavity is connected to the system ground through embedded conductive screws, conductive gaskets, or crimping components, thereby ensuring that the handheld operator 200, as a solid Faraday cage, can provide at least 60dB of electromagnetic interference (EMI) attenuation in the frequency range of 10MHz to 1GHz, effectively shielding external electromagnetic interference and protecting internal sensitive electronic components and signal transmission paths.

[0051] Further, the interior of the shell 210 is used to accommodate and fix the shell 210, the rotary transmission mechanism 300, the signal output module 400, the processing module, and the display module 500, and to provide them with precise mounting surfaces, limiting structures, and necessary vibration isolation (such as through silicone rubber damping components) to ensure the stability of the system components during operation. The front end of the shell 210 is provided with a guidewire inlet 211, which is designed as a smooth horn transition with an inlet diameter of 0.8mm-1.2mm and a taper angle of 10°-15°, so as to facilitate smooth insertion of the pressure guidewire 100 and minimize the scratching or damage that the guidewire coating may suffer. Moreover, the outer surface of the guidewire inlet 211 is left with a gap or connected through a bearing to the shell 210, allowing the guidewire inlet 211 to rotate axially relative to the shell 210.

[0052] Figure 2 and Figure 3 respectively show the perspective structural diagram and the exploded view of the rotary transmission mechanism 300 of the present embodiment. The rotary transmission mechanism 300 is the core component that reliably clamps the pressure guidewire 100, transmits the operating torque, and establishes a stable physiological signal transmission path. The rotary transmission mechanism 300 is arranged as a whole inside the front end of the shell 210 and can partially protrude from the shell 210 for ease of operation. The rotary transmission mechanism 300 is composed of a fixing mechanism 310, a rotor 320, and a stator 330. The fixing mechanism 310 is responsible for mechanically clamping the pressure guidewire and initially switching the electrical signal, the rotor 320 is responsible for locking and transmitting the rotary torque, and the stator 330 provides a stationary signal receiving platform and realizes non-contact signal transmission through liquid metal medium.

[0053] Specifically, the core of the fixing mechanism 310 is a clamping unit composed of multiple clamping petals 311. The clamping petals 311 are composed of three or four petals, and the main body is made of medical-grade insulating material polyether ether ketone (PEEK, such as Victrex PEEK 450G) by precise injection molding or CNC machining. A plurality of independent metal conductors are integrated in the insulating main body by precise casting process or fine circuit board (FPC) in advance to form clamping petal pins.

[0054] These clamping petal pins are made of gold-plated beryllium copper alloy, exposed on the inner wall surface of the clamping petal 311 (the side facing the pressure guide wire 100) in the form of an arc-shaped conductive sheet, which is accurately corresponding to the axial distribution position of the plurality of signal rings 120 and the common ground connection ring 130 near the proximal end of the pressure guide wire 100, so as to establish reliable electrical contact with them one by one when clamping. At the same time, the clamping petal pins are also exposed on the outer wall surface of the clamping petal 311 (the side away from the pressure guide wire 100), forming an electrical contact area for establishing electrical connection with the rotor 320. Each clamping petal pin is in the form of an arc-shaped conductive sheet extending along the circumference of the pressure guide wire 100 on the inner wall of a single clamping petal 311, and each clamping petal pin is completely isolated by the main body insulating material, ensuring independent transmission of physiological signals and avoiding cross-talk. After the multiple clamping petals 311 are combined in a ring, the center forms a clamping hole matching the outer diameter of the pressure guide wire 100, and can be fine-tuned. It is worth noting that the outer surface of the clamping petal 311 is provided with external threads along the axial direction.

[0055] Further, the ends of the multiple clamping petals 311 towards the guide wire inlet 211 are designed as one body and are movably connected with the guide wire inlet 211, facilitating the pressure guide wire 100 to directly enter the surrounding area composed of the multiple clamping petals 311 from the horn-shaped guide wire inlet 211.

[0056] Specifically, the end of the clamping petal group is movably connected with the guide wire inlet 211 through sliding key grooves or splines, so that the clamping petal group can slide in a small range along the guide wire axis, but cannot rotate alone around its own axis.

[0057] The rotor 320 of the present embodiment is a component that integrates locking, rotational transmission and physiological signal relay functions. The inner wall of the rotor 320 is threaded, and engages with the external threads on the outer surface of the clamp segment 311. The rotor 320 is mounted on the housing 210 via a bearing assembly (e.g. double-row micro stainless steel bearing) to allow it to rotate freely around the axis of the pressure guidewire 100, with very low friction. The rotor 320 is provided with a handle that extends outside the housing 210, allowing medical personnel to hold the handle outside the housing 210 and rotate the rotor 320. Further, the outer surface of the clamp segment 311 is a conical surface (or similar bevel), and the inner wall of the rotor 320, which matches it, is also a conical surface. When it is necessary to tighten the clamp segment 311 to secure the pressure guidewire 100, the rotor 320 is rotated, which pushes the clamp segment set axially towards the inside of the housing (in the direction away from the guidewire inlet) or towards the outside, via the threads. When the clamp segment set moves axially, the conical inner wall of the rotor 320 presses the clamp segment 311, forcing it to contract radially and grip the guidewire, achieving reliable mechanical fixation and torque transmission.

[0058] On the surface of the rotor 320 facing the clamp segment 311, a plurality of rotor pins are uniformly distributed. The rotor pins are made of elastic conductive elements such as gold-plated spring pins, ensuring that when the clamp segment 311 is tightened, the rotor pins can establish a continuous and stable electrical connection with the electrical contact area on the outer wall surface of the clamp segment 311.

[0059] The stator 330 of the present embodiment is fixedly installed on the housing 210 and remains stationary, with its end surface opposite that of the rotor 320. On the end surface of the stator 330 opposite the rotor 320, the surface of the stator 330 is provided with a plurality of independent annular grooves, with a depth of 1mm-5mm and a width of 1mm-5mm. The surface of the rotor 320 is provided with a plurality of annular protrusions that match and are concentric with the annular grooves of the stator 330. When assembled, the annular protrusions of the rotor 320 and the corresponding annular grooves of the stator 330 form a plurality of small, uniform fluid gaps 340, with a width of 15μm-30μm. The number of these fluid gaps 340 matches the number of physiological signal channels led inside the pressure guidewire 100 (the sum of the number of signal rings 120 and the number of ground connection rings 130), for example, two differential signals and one ground line for FFR measurement, which requires at least three fluid gaps 340.

[0060] It should be noted that each rotor pin provided on the rotor 320 is connected to the outer end face of the rotor 320 through a micro coaxial cable or a flexible printed circuit board (FPC) and extends into the respective corresponding fluid gap 340, ensuring low loss and low crosstalk of signal transmission. On the side of the stator 330 of the fluid gap 340, a stator pin is provided, which is an arc-shaped conductor matching the shape of the respective fluid gap 340 and is made of a high-conductivity gold-plated copper alloy (for example, C17200 beryllium copper alloy, with a gold-plated surface thickness of 3-5 μm). The stator pin is connected to the signal output module 400 through an embedded microstrip line or a shielded cable.

[0061] Each fluid gap 340 is filled with a liquid metal medium, thereby forming a continuous and mechanically wear-free conductive path between the rotor 320 and the stator 330. The liquid metal medium uses a conductive gallium-based eutectic alloy that remains liquid at room temperature (20-30°C), with a standard composition of about 68%±2% gallium (Ga), about 20%±1% indium (In), and about 12%±1% tin (Sn). The melting point of this alloy is below 15°C, with ultra-low viscosity (typically below 2 mPa·s, close to the viscosity of water), and electrical conductivity as high as 3.4 x 10 6 S / m. In addition, this gallium-based alloy also exhibits good biocompatibility (tested by ISO 10993 series) and low vapor pressure, ensuring safe use in medical environments. The ultra-low viscosity of the liquid metal medium is the key to the infinite rotational freedom of the present application, which ensures that almost no mechanical frictional resistance is generated when the rotor 320 rotates relative to the stator 330, and according to fluid mechanics calculations, the shear torque generated is less than 0.0001 Nm when the rotational speed reaches 500 RPM, thereby maximizing the perception accuracy of the medical staff's torque feedback on the pressure wire 100. At the same time, the liquid metal medium can provide uninterrupted and large-area conductive contact, effectively avoiding the contact resistance fluctuations and electrical noise caused by the jumping, wear or oxidation of the contact points of traditional solid brushes, ensuring ultra-low loss (insertion loss less than 0.01 dB) and extremely high stability of the microvolt-level physiological signals (such as FFR signals, with an amplitude typically in the tens of microvolts to hundreds of microvolts), and the typical contact resistance can be stably maintained at the mΩ level, greatly improving the stability and purity of signal transmission.

[0062] Further, a labyrinth seal ring is arranged on the side wall of the annular groove of the stator 330, which is made of non-wetting material, such as polytetrafluoroethylene treated by plasma enhanced chemical vapor deposition (PECVD) or medical-grade ceramic material with a liquid-repellent surface. The PECVD treatment can form a nanostructured layer with extremely low surface energy and high contact angle (> 150°) on the PTFE surface, effectively repelling liquid metal. The minimum feature size of the microfluidic channel is precisely controlled to be between 5 μm and 8 μm to fully utilize the microfluidic effect. The labyrinth seal ring is fixed to the side wall of the annular groove of the stator 330 by an embedded structure (such as a micro barb or laser welding), and forms a non-contact fit with the annular protruding structure of the rotor 320, maintaining a micron-level gap. Its working principle is to utilize the capillary force effect and surface tension generated by the microchannel to effectively constrain the axial flow of the liquid metal medium, preventing medium leakage or contamination due to centrifugal force (at high speed) or long-term use. This dynamic sealing design significantly improves the environmental robustness, reliability and long-term stability of the conductive circuit under the premise of ensuring zero-friction rotation.

[0063] The working principle of the rotary transmission mechanism 300 is as follows: the proximal end of the pressure guide wire 100 is inserted and passed through the rotor 320 and the clamp 311 group; the rotor 320 is rotated to drive the clamp 311 group to radially contract and tightly hold the pressure guide wire 100 through threaded transmission; in this process, the pin on the inner wall of the clamp 311 comes into contact with the annular signal ring 120 / ground connection ring 130 on the surface of the pressure guide wire 100; at the same time, the contact on the outer wall surface of the clamp 311 maintains electrical connection with the rotor pin.

[0064] The physiological signal transmission path is: guide wire signal ring 120 / ground connection ring 130→clamp 311 pin→clamp 311 outer wall electrical contact area→rotor pin→liquid metal medium→stator pin→signal output module 400 and processing module. In the entire operation process, no matter how the rotor 320 rotates, the physiological signals of each channel can be transmitted through their independent paths without loss and cross talk.

[0065] The rotation transmission mechanism 300 of the present application fundamentally solves the inherent contradiction between high-fidelity transmission of physiological signals and flexibility of instrument operation of the pressure guide wire in interventional surgery through its unique "fixed mechanism 310-rotor 320-stator 330" three-stage transmission and signal transmission design. Specifically, the fixed mechanism 310 adopts a multi-clamshell 311 composite structure, and when the independent metal conductor (clamshell pin) pre-embedded in the insulating body is radially clamped around the guide wire, it can simultaneously establish multi-point, parallel electrical connections with the signal ring 120 and the common ground connection ring 130 at the proximal end of the guide wire. Not only does it achieve reliable mechanical clamping of the guide wire, but more importantly, it establishes an initial electrical signal path from the rotating guide wire to the rotating rotor 320, and strict insulation isolation is maintained between the signal channels. The rotational torque applied by the doctor to the guide wire is directly transmitted to the rotor 320 through the clamshell mechanism, ensuring that the torque feedback between the hand and the tip of the guide wire is infinitely close to 1:1, restoring the crucial "hand feel".

[0066] In contrast to the problem of loss of rotational freedom and torque feedback distortion caused by complete fixation of the proximal end of the guide wire in the prior art, the present application realizes electrical signal connection between the rotor 320 and the stator 330 through the fluid gap 340 filled with liquid metal medium. The liquid metal medium (such as gallium-based alloy) has the characteristics of ultra-low viscosity and extremely high electrical conductivity, so that the rotor 320 almost does not produce mechanical friction resistance when it rotates continuously relative to the stator 330, while providing a large-area, uninterrupted stable conduction path. This design allows the doctor to rotate and axially push the pressure guide wire 100 without any number of turns, just like operating a normal interventional guide wire, completely freeing the doctor from the constraints of cable entanglement, and thus achieving precise navigation in complex vascular pathways.

[0067] Further, the liquid metal medium avoids the problems of contact point jumping, wear and oxidation of traditional slip ring brushes, reducing contact resistance fluctuations and electrical noise to a very low level. In combination with the labyrinth seal ring provided on the two side walls of the annular groove of the stator 330, the labyrinth seal ring effectively prevents leakage of the liquid metal through capillary force effect, ensuring the long-term environmental robustness of this ultra-low loss conduction path. In particular, the microvolt-level physiological signals (such as FFR signals) achieve ultra-high performance with an insertion loss of less than 0.01 dB and a contact resistance stabilized at the milliohm level in the entire path from the rotating guide wire to the stationary signal output module 400 and processing module, ensuring extremely high fidelity and stability of physiological signal measurement. In summary, the rotation transmission mechanism 300 successfully integrates the excellent mechanical controllability of the guide wire with the extremely high stability of electronic signal transmission, significantly improving the safety, efficiency and precision of coronary intervention surgery without sacrificing any performance.

[0068] The signal output module 400 of the embodiment is integrated on a micro multi-layer printed circuit board (PCB) at the end of the annular groove of the stator 330 or immediately behind the back side thereof, and is directly connected to the stator pin through an extremely short built-in line. This close integration maximally shortens the wire length from the rotating interface (the junction of the liquid metal and the stator pin) to the first-stage signal processing circuit of the signal output module 400, effectively reduces the noise coupling caused by the line as an antenna effect, and reduces the parasitic capacitance and inductance. It should be noted that one signal output module 400 is provided for each rotating interface, and signals from the signal ring 120 or the common ground connection ring 130 are processed separately.

[0069] Specifically, the signal output module 400 includes a differential amplification unit, a noise suppression unit, a multi-stage filtering unit, and an isolated power supply unit.

[0070] The differential amplification unit directly receives the differential physiological signals transmitted from the liquid metal medium. The differential amplification unit is specifically a high-performance instrumentation amplifier integrated circuit (Instrumentation Amplifier IC), such as Analog Devices AD8421 or Texas Instruments INA188. The integrated circuit has a common-mode rejection ratio (CMRR) greater than 100 dB, and can still maintain a CMRR greater than 80 dB in the power line frequency (50 Hz / 60 Hz) and electrocardiogram bandwidth (0.05 Hz-150 Hz) ranges, thereby efficiently removing external electromagnetic interference or common-mode noise. The input impedance of the differential amplification unit is greater than 1 GΩ (specifically at the 10 12 Ω level, and the input capacitance is less than 5 pF), ensuring that there is no load effect on the weak pressure sensing unit signal. The equivalent input noise voltage is less than 5 nV / √Hz, ensuring a very high signal-to-noise ratio.

[0071] Further, the differential amplification unit also integrates a programmable gain amplifier (PGA) that provides a gain selection of 10 times-1000 times, with a step precision of 1 times-10 times, to adapt to physiological signals of different amplitudes, and amplify the microvolt-level signal (such as several tens of μV) to a millivolt-level range (such as several hundred mV to several V) that can be processed, while effectively suppressing the common-mode noise that may be superimposed on the signal during rotation or external electromagnetic interference, and converting it into a differential signal for amplification processing.

[0072] A noise suppression unit is used to digitize the signal amplified by the differential amplification unit and identify and suppress dynamic noise in the digitized signal. The signal digitization is performed by an analog-to-digital converter (ADC), specifically, a 24-bit resolution Sigma-Delta converter (e.g., Analog Devices AD7177-2 or Texas Instruments ADS129x series bio-signal acquisition ADC) with a sampling rate of up to 10 kHz to 100 kHz per channel, ensuring complete capture of signal details. Further, the identification and suppression of noise is based on the least mean square (LMS) algorithm or recursive least squares (RLS) algorithm, which monitors the signal characteristics and noise spectrum of each channel in real time. By analyzing the dynamic noise components in the signal, such as transient potential fluctuations caused by micro-friction or surface tension changes between liquid metal and interface materials, power line harmonic interference (e.g., 50 Hz / 60 Hz and its higher harmonics), and high-frequency radio frequency noise (e.g., from surgical room electric knives or wireless communication devices), the noise suppression unit generates a noise reference signal highly correlated with the actual noise. Through real-time subtraction operations or adaptive equalization techniques, the noise components identified are accurately removed or suppressed from the physiological signal, achieving precise removal of complex dynamic noise.

[0073] A multi-stage filtering unit is used to receive the signal after differential amplification and noise suppression, and perform multi-stage fine filtering. The multi-stage filtering unit is composed of a multi-stage filter array, including a low-pass filter, a notch filter, and a high-pass filter in sequence. The low-pass filter is a 4th-order Butterworth low-pass filter with a flat passband response and a 100 Hz-150 Hz cutoff frequency, which is used to remove high-frequency noise above the bandwidth of the physiological signal. The passband ripple is less than 0.1 dB, and the stopband attenuation is greater than 40 dB / octave. The notch filter is a narrow-band notch filter specifically targeting 50 Hz / 60 Hz and its second and third harmonics (e.g., 100 Hz / 120 Hz, 150 Hz / 180 Hz), with an adjustable Q factor for efficient elimination of power line interference. The high-pass filter is a 2nd-order Butterworth high-pass filter with a 0.05 Hz cutoff frequency, which is used to remove baseline drift and respiratory motion artifacts, ensuring the accuracy of FFR calculation. The multi-stage filter array works together to further improve the signal-to-noise ratio and purity of the signal, ensuring that the final output signal has the highest fidelity in the frequency range required for clinical diagnosis.

[0074] The isolated power supply unit is a DC-DC converter (e.g. Murata MGJ series or Analog Devices ADuM5010) with 2500Vrms isolation voltage, combined with a low dropout linear regulator (LDO, e.g. Analog Devices ADP7118) with low output noise (less than 10μVrms, typical value 5μVrms) to provide ultra-low noise isolated power supply for the differential amplifier. This isolated design not only ensures patient safety, but also effectively breaks the ground loop that may introduce noise, further improving the purity of the signal.

[0075] The differential physiological signals from the liquid metal medium transmission are directly connected to the input of the signal output module 400, which then performs a series of processing on the received weak physiological signals: first, differential amplification with high common-mode rejection ratio, then dynamic noise suppression based on adaptive algorithm, and finally precise filtering processing through a multi-stage fine filter array. The high-purity signals after processing will be output to the signal output module 400 and further sent to the processing module for real-time analysis. Throughout the operation process, no matter how the medical staff rotates the rotor 320 to operate the guide wire, the physiological signals of each channel are transmitted through their own independent liquid metal path, realizing lossless and crosstalk-free transmission, and the signal integrity is always guaranteed.

[0076] The liquid metal medium of the present application is highly synergistic with the signal output module 400, fundamentally solving the noise and stability problems of microvolt-level physiological signals in infinite rotation transmission. Among them, the liquid metal medium has excellent ultra-low viscosity and high conductivity characteristics, which ensures that when the rotor 320 realizes infinite rotation, the electrical connection between the signal from the rotor pin to the stator pin is always continuous, without mechanical wear and contact resistance fluctuation, and the dynamic contact resistance fluctuation is much lower than that of the traditional solid brush. Due to its fluidity, the liquid metal medium itself produces very low mechanical and electrical noise, providing a clean input signal source for subsequent signal processing, which is the physical basis for ensuring the original integrity of the signal. And the signal output module 400, on the basis of this solid physical foundation, realizes deep noise removal through intelligent and dynamic electronic means. Specifically, the built-in differential amplification unit can efficiently remove the common-mode noise induced on the signal line by external electromagnetic interference (such as the electromagnetic environment in the operating room). Subsequently, the noise suppression unit and the multi-stage fine filter array can identify and accurately filter transient potential fluctuations, power supply ripple and other residual differential noise (such as voltage offset caused by micro-movement) in real time under high-speed or uneven rotation conditions. Through the high synergy of physical and electronic layers, the present application system ensures the extreme purity and stability of microvolt-level physiological signals, greatly improves the signal-to-noise ratio of physiological signal measurement, and fully meets the extreme purity and reliability required for clinical applications.

[0077] The processing module of the present embodiment is integrated on a multi-layer PCB circuit board and installed inside the shell 210 of the handheld controller 200. The processing module includes: a data acquisition unit for communicating with an analog-to-digital converter (ADC) through a high-speed SPI or I2S interface to realize synchronous acquisition of multi-channel physiological signal data, ensure low delay and synchronization of data transmission, and support millisecond-level data update rate; a signal calibration unit for zero-point drift correction, gain calibration and temperature compensation of the acquired physiological signal, real-time adjustment of signal reference through built-in algorithm to ensure the accuracy and stability of pressure measurement; an FFR calculation unit based on real-time acquisition of distal pressure (Pd) and proximal pressure (Pa) data, dynamically calculating the coronary flow reserve fraction (FFR) value according to the Pd / Pa formula, supporting configurable average window setting, and realizing real-time display of fractional flow reserve; a differential pressure analysis unit for synchronous comparison and analysis of distal pressure (Pd) and proximal pressure (Pa) waveforms, identifying the instantaneous pressure gradient before and after the stenosis lesion, and quantifying the dynamic change of pressure difference; a data storage unit with at least 4GB of eMMC flash memory for continuously storing multi-channel physiological waveform data, FFR calculation results and related surgical parameters, supporting at least 10 hours of continuous data recording, facilitating postoperative review and scientific analysis.

[0078] The display module 500 of the embodiment is arranged on the outer upper side of the shell 210, and is used for displaying physiological parameter information output by the processing module in real time. The display module 500 comprises: a display unit, which adopts a 2.8-inch QVGA (320*240 pixels) color liquid crystal display screen, has high contrast, wide viewing angle and sufficient brightness, and is used for clearly displaying point blood pressure information (including systolic pressure, diastolic pressure and mean pressure), FFR values, real-time pressure waveform diagrams and other related physiological parameters (such as heart rate and vascular resistance index); and a driving control unit, which is integrated on a PCB of the processing module, realizes smooth real-time waveform drawing and interface refreshing through an optimized graphics library, and ensures the readability of the display content and the operation response speed under complex lighting conditions.

[0079] The following is a comparative test specially designed to verify the actual performance of the handheld pressure guide wire system provided by the present application. The test is based on an in-vitro environment simulating a real coronary intervention operation, which includes a high-precision blood vessel model whose geometric structure and elastic modulus strictly imitate human coronary arteries, and is equipped with a pump system that can simulate physiological pulsatile blood flow and an adjustable local stenosis module. A calibrated reference pressure sensor (accuracy ±0.005 mmHg) is implanted in the model for providing a true value reference (set to 0.75) of the fractional flow reserve (FFR). During the test, the mean arterial pressure (Pa) is maintained at 90 mmHg to simulate a coronary artery stenosis with an FFR true value of 0.75.

[0080] The test includes five groups, including two groups of preferred embodiments of the present application and three groups of comparative examples.

[0081] Example 1: A pressure guide wire with three pressure sensing units is used, which has an outer diameter of 0.35 mm and an effective length of 180 cm. The distal end is integrated with three micro piezoresistive pressure sensing units, and the signal line and ground line are 5 μm gold-plated tungsten wires insulated by polyimide. The proximal end is provided with three platinum-iridium alloy signal rings and one common ground connection ring, with a width of 0.15 mm. In the rotary transmission mechanism, the clamp, rotor and stator are made of PEEK material, the clamp is embedded with gold-plated beryllium copper pins, the annular groove on the surface of the stator has a depth of 3 mm and a width of 4 mm, the fluid gap between the stator and the rotor is 340 μm, and the width is 20 μm, and the rotor pin and the stator pin are both C17200 beryllium copper alloy. The liquid metal medium filled therein is a eutectic alloy of gallium 68%, indium 20% and tin 12%, which has a dynamic viscosity of 1.8 mPa·s at 25°C and an electrical conductivity of 3.4*10 6 S / m.

[0082] Example 2: Based on Example 1, the difference is that two pressure sensing units are arranged on the pressure guide wire.

[0083] Comparative Example 1 : Based on Example 1, the difference is that the liquid metal medium between the stator and the rotor of the rotary transmission mechanism is not used, but a slip ring assembly consisting of 12 gold-plated beryllium copper alloy multi-contact solid brushes (brush contacts) is used. Each brush provides a contact force of 20 g.

[0084] Comparative Example 2: Based on Example 1, the difference is that the liquid metal medium between the stator and the rotor is replaced by an indium-gallium alloy (In 75%, Ga 25%).

[0085] Comparative Example 3: Based on Example 1, the difference is that the width of the fluid gap 340 between the stator and the rotor is 45 pm.

[0086] The experimental method is as follows: the pressure guide wire of each example and comparative example is inserted into the blood vessel model, so that it passes through the stenosis site, the proximal end is clamped and fixed by the rotary transmission mechanism, and the stator pin output signal is connected to a high-precision data acquisition system. First, the signal is collected for 60 s in the static state to evaluate the signal-to-noise ratio and signal stability of each channel; then, under the dynamic condition of continuously rotating the rotor at 100 rpm / min, the signal drift and the deviation of the FFR calculation value from the true value are recorded. The detailed experimental results are shown in Table 1.

[0087] Table 1. Summary of experimental results

[0088]

[0089] As can be seen from Table 1, the average signal-to-noise ratio of Example 1 in the static state is 62.5 dB, the signal standard deviation is 0.8 pV, the signal drift during dynamic rotation is 5.2 pV, and the average absolute error of FFR calculation is 0.008. The performance of Example 2 is comparable, indicating that the system remains stable output when the number of channels changes. Comparative Example 1 uses solid brush structure, the signal-to-noise ratio is significantly reduced to 42.1 dB, the signal drift reaches 85.0 pV, and the FFR error rises to 0.085, showing the inherent defects of mechanical contact transmission in noise control and long-term stability. Comparative Example 2 has a lower liquid metal conductivity and higher viscosity, with performance between Example 1 and Comparative Example 1, indicating that the medium composition has an important influence on signal quality.

[0090] Comparative Example 3 increases the width of the fluid gap 340 to 45 pm, and its performance shows a significant decline, with a signal drift of 15.7 pV. The increase in gap weakens the capillary constraint of the labyrinth seal, causing uneven distribution of the liquid metal during rotation, dynamic fluctuations in contact resistance, and signal drift. More importantly, the increase in gap increases the volume of the filled liquid metal medium, and the cross-sectional area of the conductive liquid bridge between adjacent signal channels increases, and the effective distance decreases. This significantly enhances the stray capacitance coupling and electromagnetic interference between the channels, leading to an increase in the background noise and a decrease in the channel isolation, thereby causing multi-channel signal crosstalk.

[0091] In summary, the present application, by adopting a liquid metal medium with specific components and a precisely controlled fluid gap 340 structure, effectively guarantees the high-fidelity and low-noise transmission of microvolt-level physiological signals while achieving infinite rotational freedom of the pressure guide wire, significantly outperforming traditional brush slip ring solutions and other non-optimized designs, fully verifying its technical effect of improving operation perception and measurement accuracy in coronary intervention surgery.

[0092] The present application provides a handheld pressure guide wire system, which, through its liquid metal rotary interface, guarantees the ultimate stability and low-friction rotation of signal transmission at the physical level, and combines a signal interference suppression unit to achieve deep noise removal of weak physiological signals at the electronic level. This synergistic effect fundamentally solves the inherent contradiction between high-fidelity transmission of physiological signals and flexibility of instrument operation in traditional pressure guide wires, significantly improving the safety, efficiency, and precision of coronary intervention surgery without sacrificing the performance of either party. Medical personnel can rotate and axially push the pressure guide wire without any round limit, completely freeing themselves from the constraints of traditional cable winding and restoring the precise "hand feeling" feedback of the guide wire head end, thereby achieving more precise navigation and operation in complex vascular paths.

[0093] At the same time, through highly integrated processing modules and display modules, the system eliminates the inconvenience of traditional pressure guide wires that require connection to large external devices to obtain monitoring information, and improves it to a handheld portable device, greatly improving the convenience, flexibility of clinical application, and space efficiency of the operating room. The combination of the technical solutions of the present application cannot be achieved by simply combining or replacing based on existing technology by persons skilled in the art, and it exhibits non-obvious innovation in liquid metal conductive sealing, microvolt-level signal dynamic noise suppression, and high-precision mechanical transmission and electrical coupling integration, thereby achieving performance indicators that traditional solutions cannot achieve.

[0094] Based on the ideal embodiments of the present application, through the above description, relevant personnel can make various changes and modifications without deviating from the scope of the technical idea of the present application. The technical scope of the present application is not limited to the contents of the specification, and must be determined by the scope of the claims.

Claims

1. A hand-held pressure wire system, characterized in that, The application relates to a handheld controller for pressure wire, comprising: a pressure wire with multiple pressure sensing units, the signals of the pressure sensing units being outputted through multiple signal rings and a common connection ring arranged at the proximal end of the pressure wire; and the handheld controller comprising a shell, a rotating transmission mechanism being arranged inside the shell, the rotating transmission mechanism comprising: a fixing mechanism with multiple clamping petals for mechanically clamping the pressure wire, the pins on the inner wall of the clamping petals being electrically connected with the signal rings and the common connection ring of the pressure wire; a rotor being rotatably arranged on the shell through a bearing assembly, the rotor being electrically connected with the electrical contact area on the outer wall of the clamping petals through rotor pins; and a stator being fixedly installed in the shell and opposite to the rotor, multiple annular grooves being arranged on the surface of the stator, multiple annular protruding structures being arranged on the surface of the rotor and matched with the annular grooves, multiple fluid gaps being formed between the annular protruding structures and the annular grooves and filled with liquid metal medium, and stator pins being arranged on the stator side of the fluid gaps. The handheld controller further comprises: a signal output module connected with the stator pins through an internal circuit, used for receiving and pre-processing physiological signals transmitted by the liquid metal medium; a processing module connected with the signal output module, used for analyzing and processing the pre-processed physiological signals to calculate blood flow reserve fraction and / or perform pressure difference analysis; and a display module arranged on the shell and connected with the processing module, used for displaying physiological parameter information in real time. The fixing mechanism is composed of three or four clamping petal ring combinations, the main body of the clamping petal is made of medical-grade insulating material, the clamping petal pins are embedded in the main body of the clamping petal and exposed on the inner wall surface and the outer wall surface of the clamping petal in the form of arc-shaped conductive sheets. The outer surface of the clamping petal is provided with external threads and is a conical surface, the inner wall of the rotor is provided with internal threads matched with the external threads and is a conical surface matched with the outer surface of the clamping petal; by rotating the rotor, the multiple clamping petals are driven to axially displace through the thread pair, and then the clamping petals are forced to radially contract to tightly hold the pressure wire through the conical surface cooperation. The front end of the shell is provided with a wire inlet, the outer surface of the wire inlet is connected with the shell through a gap or a bearing, so that the wire inlet can rotate around the axial direction of the shell relative to the shell. The end of the multiple clamping petals towards the wire inlet is an integral structure and is movably connected with the wire inlet through a sliding key groove or a spline, so that the multiple clamping petals can slide in a small range along the axial direction of the pressure wire and cannot independently rotate around the axial line thereof. The width of the fluid gap is 15-30 mu m, and the number of the fluid gaps is consistent with the total number of the signal rings and the common connection ring arranged at the proximal end of the pressure wire. The liquid metal medium is a liquid gallium-based eutectic alloy at room temperature, and the composition of the liquid metal medium is as follows in terms of weight percentage: gallium 66%-70%, indium 19%-21% and tin 11%-13%. ​ ​ ​ 2. A handheld pressure wire system according to claim 1, characterized in that: ​ 3. The handheld pressure wire system of claim 1, wherein: ​ 4. The handheld pressure wire system of claim 1, wherein: ​ 5. A handheld pressure wire system according to claim 4, wherein: ​ 6. The handheld pressure wire system of claim 1, wherein: ​ 7. The handheld pressure wire system of claim 1, wherein: ​ 8. The handheld pressure wire system of claim 1, wherein: The stator is provided with a labyrinth seal ring on each side wall of the annular groove, and a micron-level non-contact cooperation is formed between the labyrinth seal ring and the annular protruding structure of the rotor.

9. The handheld pressure wire system of claim 1, wherein: The signal output module comprises: A differential amplification unit is configured to directly receive and amplify the differential physiological signal from the stator pin; A noise suppression unit is configured to digitize the amplified signal and identify and suppress the dynamic noise in the digitized signal based on an adaptive algorithm; A multi-stage filtering unit is configured to perform frequency domain filtering on the noise-suppressed signal, and the filtering link comprises a low-pass filter, a notch filter and a high-pass filter arranged in sequence.

10. The handheld pressure wire system of claim 1, wherein: The processing module comprises a data acquisition unit, a signal calibration unit, an FFR calculation unit, a differential pressure analysis unit and a data storage unit.

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