Clinical multi-modal guided painless flying needle blood sampling system

Abstract

This invention discloses a clinical multimodal guided painless flying needle blood collection system, belonging to the field of medical device technology. The system includes a collection tube, a blood collection needle, a flying needle transmitter, an infrared vascular imaging device, a multimodal fusion control unit, and a machine learning optimization module. The flying needle transmitter drives the blood collection needle through an elastic element to complete the puncture at ultra-high speed, with the puncture time shorter than the pain transmission time window, achieving physical painlessness. The blood collection needle integrates an optical sensing unit, utilizing a gradient refractive index lens and a micro-mirror array to achieve multi-directional optical detection and real-time feedback of the three-dimensional interaction state between the needle tip and the tissue. The system integrates infrared images and optical sensing data, and through machine learning optimization, can automatically adjust puncture parameters to achieve precise and adaptive puncture guidance.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a clinical multimodal guided painless flying needle blood collection system. Background Technology

[0002] Venous blood collection is one of the most routine procedures for obtaining blood samples in clinical diagnosis and treatment. Traditional manual venipuncture by medical staff is slow, painful, and highly dependent on experience for accuracy, easily leading to failure due to inaccurate judgment of the location, direction, and depth of subcutaneous vessels. To reduce pain, existing technologies such as spring-driven capillary blood collection devices, miniaturized needles, or "painless flying needle" manual techniques either have designs that are incompatible with standard venipuncture or are difficult to standardize and popularize, thus failing to meet the widespread clinical needs. In terms of precise guidance, technologies such as infrared vascular imaging can only provide a two-dimensional surface projection of the blood vessel, lacking depth information and unable to provide real-time feedback on the positional relationship between the needle tip and the blood vessel, resulting in delays and uncertainties in the operation. Furthermore, in the field of clinical teaching, training in venipuncture skills has long faced challenges: trainees cannot intuitively perceive the changes in mechanical feedback when the needle tip penetrates different tissue layers, nor can they objectively assess the relationship between their own operational key parameters and puncture success rate. Instructional guidance often relies on subjective experience descriptions, resulting in a long learning curve for trainees, and existing teaching models cannot realistically reproduce the tissue mechanical interaction characteristics during the puncture process. In recent years, with the development of artificial intelligence technology, some studies have attempted to apply machine learning to puncture guidance. A typical approach involves using a large amount of infrared images and corresponding puncture result data to train a classification model to predict the success probability under specific puncture parameters. However, this method has a fundamental flaw: the determination of "puncture success," which serves as the "label" for model training, usually relies on the indirect, delayed, and multi-factor-affected clinical phenomenon of blood return. Blood return cannot precisely correspond to the physical moment when the needle tip enters the blood vessel lumen, and it cannot distinguish between different situations such as "blood return after puncturing the contralateral wall of the blood vessel" and "blood return after precise entry into the lumen." Therefore, there is an urgent clinical need for an integrated intelligent device that combines ultra-high-speed painless puncture, real-time precise guidance, and compatibility with vacuum blood collection. This device not only needs to achieve supraphysiological reaction speed at the mechanical level to avoid pain, but also needs to solve two core problems at the information level: first, how to acquire real-time data on the interaction between the needle tip and tissue; and second, how to build a high-precision predictive model based on this data. Summary of the Invention

[0003] This invention aims to provide a clinical multimodal guided painless flying needle blood collection system. Through integrated mechanical design, it enables operators to achieve supraphysiological reaction speed venous puncture in a standardized and easy-to-master manner. By introducing an optical sensing unit, it realizes intelligent guidance and adaptive control of the puncture process from two-dimensional planar positioning to three-dimensional spatial interaction.

[0004] The present invention adopts the following technical solution: A clinical multimodal guided painless needle aspiration system includes a collection tube, a needle at the front end of the collection tube, and a needle launcher connected to the collection tube. The needle launcher includes a guide rod, an elastic element sleeved on the guide rod, and a button for actuating the elastic element. The launcher drives the needle to perform high-speed puncture at an average speed of not less than 200 mm / s, enabling it to complete the process from initiation to hitting the target subcutaneous blood vessel in less than 0.3 seconds, thereby achieving painless or minimally painless blood aspiration at the physical level within the physiological pain transmission time window.

[0005] To achieve real-time and precise guidance during the puncture process, the tip region of the blood collection needle integrates an optical sensing unit. This unit includes an optical fiber extending along the axial direction of the blood collection needle. The distal end of the optical fiber is fixed within the needle tube via a helical path and is secured with a gradient refractive index lens. A micromirror array is circumferentially distributed on the outer surface of the lens. In dynamic environments where the needle tip penetrates tissue at speeds exceeding 200 mm / s, traditional optical detection methods cannot effectively handle highly dynamic, multi-source mixed transient signals. The principle of the optical sensing unit of this invention lies in the fact that the interaction between the needle tip and different tissue layers induces instantaneous mechanical disturbances in the tissue's microstructure, thereby modulating the optical path of the reflected light and leaving a unique imprint in the optical phase. By capturing this phase fluctuation in real time using high-sensitivity interferometric detection technology and employing phase fluctuation power spectral analysis for deep feature extraction, the system can convert the frequency domain features contained in the phase fluctuations, which are highly correlated with tissue physical properties (such as viscoelasticity and density) and dynamic events (such as penetration of blood vessel walls), into decodeable signals. This enables clear and reliable real-time identification of the precise tissue state at the needle tip and the moment of critical event transition during the transient process of high-speed puncture.

[0006] The near end of the gradient refractive index lens is optically coupled to the far end of the optical fiber, and the length of the gradient refractive index lens is designed such that a beam of light input from its near end has a predetermined divergence angle when it reaches its outer peripheral surface. θ , where 30°≤ θ ≤60°; The micromirror array includes at least three mirror surfaces, which are equally spaced along the circumference of the gradient refractive index lens. The micromirror array is used to guide the light signal from the gradient refractive index lens to at least two different spatial directions and couple the backscattered light signal from the at least two directions back to the gradient refractive index lens.

[0007] The divergence angle θ The value range is 30°≤ θ≤60° is an optimized design parameter determined based on the geometric matching relationship with the micromirror array. Its core lies in balancing the relationship between beam coverage and light energy utilization efficiency. If the divergence angle... θ If the angle is too small (<30°), the emitted beam will be too focused and unable to effectively cover all the reflecting mirrors distributed along the circumference, resulting in missing detection signals and making it difficult to achieve the functional goal of multi-directional synchronous monitoring; if the divergence angle is too small... θ If the divergence angle is too large (>60°), the emitted beam will diffuse excessively, significantly reducing the light energy density and resulting in insufficient illumination intensity received by each reflector, thus lowering the intensity and signal-to-noise ratio of the backscattered signal. Simultaneously, an excessively large divergence angle will cause aliasing of scattered light returning from different directions within the gradient refractive index lens, weakening the separation capability and axial resolution of the multi-channel signal. To achieve optimized matching between the divergence angle and the reflector surfaces, this invention further defines the following geometric relationship: Assume the micromirror array comprises N reflector surfaces, and the angle between the center of each reflector surface and the optical axis of the gradient refractive index lens is... ( i =1,2,...,N), where The value ranges from 0° to 30°, then the divergence angle θ Must meet θ ≥2·max( ) + ,in The redundant angle is set between 5° and 10° to ensure that each reflector is within the effective illumination range, while avoiding excessive redundancy that could lead to wasted light energy.

[0008] The specific implementation steps are as follows: The probe light from the external integrated unit is transmitted to the gradient refractive index lens via optical fiber. The gradient refractive index lens first converts the point light source output at the end of the optical fiber into a light with a predetermined divergence angle. θThe conical beam of light then illuminates an array of micromirrors, whose mirrors are precisely angled—some mirrors reflect the light forward, while others reflect it to the side and forward at a specific tilt angle, thus splitting a single beam of light into multiple spatial directions; these split probe beams simultaneously illuminate tissue at different spatial locations in front of the needle tip. Each beam of light interacts with the corresponding tissue (axial anterior wall of the blood vessel, radial lateral wall of the blood vessel, and surrounding tissue). The dynamic mechanical disturbance of the tissue microstructure modulates the optical path of the scattered light, implanting a phase fingerprint with spatial orientation characteristics into the optical phase. The backscattered light modulated by the tissue returns along an approximately original path. The micro-mirror array and the gradient refractive index lens form an angle-matched light-gathering system—the axial return light is reflected and recovered by the forward mirror, while the lateral return light is selectively captured by the lateral mirror at the corresponding angle. All recovered light signals are re-converged by the gradient refractive index lens and coupled back to the optical fiber. The light signal carrying multi-directional mixed phase information is transmitted back to the external integrated unit, where high-speed demodulation technology separates the phase fluctuation components of different optical paths (corresponding to different spatial directions). Then, it is input into the phase fluctuation power spectrum analysis module for feature decoding, ultimately realizing the real-time discrimination of the needle tip-tissue spatial relationship and action state. This multi-directional synchronous sampling mechanism not only provides rich three-dimensional spatial information to accurately determine the relative positional relationship between the needle tip and the blood vessel wall, but also enhances the robustness of the system in a high-speed dynamic puncture environment through signal redundancy design—even if the signal in one direction deteriorates in quality due to tissue heterogeneity or instantaneous contamination, the signals in other directions can still provide continuous and reliable status feedback.

[0009] Specifically, the optical sensing unit adopts a single-fiber bidirectional optical path structure. The optical fiber is a single fiber, used to transmit the probe light to the gradient refractive index lens and the backscattered light returned from the gradient refractive index lens to the external integrated unit. The micro-mirror array is also distributed inside the tip of the blood collection needle, used to reflect or scatter the probe light from the optical fiber at the needle tip into the surrounding tissue, forming a return light modulated by the refractive index of the tissue medium. The optical characteristics of the formed return light are modulated differently due to the different optical coupling states between each mirror and the surrounding tissue medium. The design of the single-fiber bidirectional optical path structure greatly simplifies the internal structure of the needle and reduces the integration complexity. Through the synergy of the gradient refractive index lens and the micro-mirror array, a point-to-multi-beam optical function is realized in the limited space of the needle tip: the single beam of probe light is efficiently split and guided to multiple spatial directions, simultaneously acquiring information on the interaction between the tissue in front of and to the side of the needle tip, and then the multiple backscattered lights are accurately recovered by the same optical system and coupled back to the single fiber.

[0010] Furthermore, the optical sensing unit also includes an external integration unit, which is connected to the proximal end of the optical fiber via a pluggable connector. The external integration unit includes: a light source module for emitting probe light to the tissue through the optical fiber; a photoelectric detection module for receiving backscattered light from the optical fiber and converting it into an electrical signal; an interference detection module for analyzing the optical phase change information contained in the backscattered light; and a processing module for identifying the tissue state based on the phase change information. The external integration unit internally includes a circulator or fiber coupler to directionally guide the probe light emitted by the light source module into the optical fiber and to directionally separate the backscattered light returning from the same optical fiber to the photoelectric detection module. When using a single-fiber bidirectional optical path, the emitted light and backscattered light transmit in the same fiber, posing a risk of signal crosstalk. Therefore, the external integration unit incorporates a fiber circulator with an isolation of no less than 40dB, effectively separating the bidirectional optical signals. The light source uses a pulse mode (pulse width 10ns~100ns), and the photoelectric detection module acquires the signal within the time window after the pulse ends, achieving time-domain separation. The interferometric detection module employs balanced detection and orthogonal demodulation, achieving a common-mode rejection ratio of over 30dB. The photoelectric detection module has a dynamic range of no less than 60dB, ensuring unsaturated signal acquisition.

[0011] The external integration unit performs the following signal processing procedure: S1: Receive the mixed optical signal from the optical fiber, and separate the mixed signal into multiple independent channel signals corresponding to the directions of each mirror in the micro-mirror array through a digital signal processing algorithm; S2: Perform time-frequency analysis on each independent channel signal to extract characteristic parameters including signal intensity change rate, power spectral density, characteristic wavelength light absorption ratio, and coherence or phase difference between multiple channels; S3: Input the extracted multi-channel feature parameters into a trained machine learning model or decision tree model to obtain the classification probability of the current tissue state of the needle tip. The tissue state includes at least: located in subcutaneous tissue, in contact with the outer wall of a blood vessel, inserted into the blood vessel wall, located in the blood vessel lumen, and in a state of being attached to the blood vessel wall.

[0012] Furthermore, this invention also includes an infrared vascular imaging device, a multimodal fusion control unit, and a machine learning optimization module. The infrared vascular imaging device is used to acquire structural image information of subcutaneous blood vessels. The multimodal fusion control unit is communicatively connected to the optical sensing unit and the infrared vascular imaging device, and is configured to: receive real-time tissue state information from the optical sensing unit and vascular structure information from the infrared vascular imaging device; and generate instructions for controlling the flying needle launcher. The system integrates the infrared vascular imaging device, the multimodal fusion control unit, and the machine learning optimization module to construct a complete intelligent puncture guidance system. Further, the elastic element of the flying needle launcher is a pre-compression spring, coupled with a pre-tension adjustment mechanism. The multimodal fusion control unit can control the pre-tension adjustment mechanism based on the output of the machine learning optimization module or the operator's input, setting the pre-tension of the pre-compression spring to a target value. The machine learning optimization module continuously collects and analyzes historical puncture data (including vascular image features, optical signal features at successful puncture, etc.) to continuously optimize its prediction model. This model can predict the optimal spring preload required for the puncture angle and depth of a specific blood vessel based on real-time acquired infrared vascular image features, and automatically set the parameters through a multi-modal fusion control unit. Furthermore, it includes a parameter recording module comprising: a displacement sensor mounted on the guide rod for real-time monitoring of the puncture depth of the blood collection needle; an attitude sensor mounted on the flying needle launcher for real-time monitoring of the puncture angle of the blood collection needle; and a data synchronization unit connected to the optical sensing unit, the displacement sensor, and the attitude sensor. The data synchronization unit is configured to: generate a trigger signal when the optical sensing unit determines that the needle tip is stably positioned within the blood vessel lumen; and based on the trigger signal, record the first value output by the displacement sensor at the current moment as the actual puncture depth, and the second value output by the attitude sensor as the actual puncture angle. The core value of this parameter recording module lies in providing the machine learning model with precise depth and angle data corresponding to the "successful puncture" moment verified by the optical sensing unit.

[0013] The flying needle launcher incorporates several structural optimizations to enhance puncture performance and operational safety. Regarding puncture dynamics optimization, this invention introduces a magnetostrictive vibration mechanism. A permanent magnet is mounted on the guide rod, and a static interactive magnetic array is arranged parallel to the launcher's movement path inside. This array consists of at least two linearly arranged unit magnets with opposite magnetization directions, forming an alternating magnetic field along the path. When the guide rod is driven at high speed by an elastic element, the permanent magnet interacts with the alternating magnetic field, experiencing periodic Lorentz forces, thus causing the blood collection needle to generate high-frequency, micro-amplitude lateral vibrations. Magnetostrictive vibrations continue to act during the needle tip contact and penetration of the skin and subcutaneous tissue. These high-frequency, micro-amplitude vibrations cause the needle tip to act on the tissue with dynamic alternating stress, effectively decomposing the continuous compressive mechanical load experienced in traditional punctures. For precise end-effector braking, this invention incorporates a kinetic energy absorption module based on electromagnetic induction. This module includes a conductor ring coaxially arranged with the guide rod. The moment the blood collection needle tip pierces the target blood vessel, the guide rod moves to its end, and the permanent magnet on it simultaneously enters the effective electromagnetic coupling region of the conductor ring. A rapidly changing magnetic field induces eddy currents within the conductor ring, generating a damping force opposite to the direction of motion. This mechanism not only eliminates needle tip bounce and vibration, preventing secondary mechanical damage to the blood vessel wall, but also ensures the needle tip remains stably suspended in the center of the blood vessel lumen, creating crucial stability conditions for subsequent smooth blood collection. The multimodal fusion control unit can control the axial position of the conductor ring on the guide rod's movement path or the electrical parameters of the conductor ring circuit based on the output of the machine learning optimization module or operator input, thereby adjusting the magnitude or timing of the damping force. Regarding overall structural reliability, the collection tube is securely connected to the flying needle launcher via an externally mounted mounting base and fixing bracket, ensuring the stability of the force transmission path. Furthermore, the flying needle launcher is equipped with a safety locking mechanism, which includes a manually switchable physical latch or electronic switch, effectively preventing accidental triggering during storage, transportation, and preparation.

[0014] The core advantage of this invention is: (1) Through a high-speed ejection mechanism of 200~300 mm / s, puncture is completed within the physiological reaction time of the pain nerve in 0.3 seconds, fundamentally blocking the generation of pain. Combined with the ultra-fine blood collection needle (0.2~0.25 mm diameter) and double bevel needle tip design, the puncture contact area is reduced by 60% and the cutting area is reduced by 35% compared with traditional needles, thereby reducing nerve ending stimulation. By generating high-frequency micro-amplitude vibration of the needle tip during puncture, "dynamic cutting" is achieved, reducing tissue resistance and further reducing pain. The device also absorbs the remaining kinetic energy through eddy current damping to prevent needle tip rebound and secondary damage. Combined with the bioimpedance intelligent feedback system, the puncture accuracy is significantly improved. Clinical tests show that the VAS pain score of adults is ≤0.8 points and that of children is ≤1 point, with a pain reduction of about 73% compared with traditional manual blood collection and about 44% compared with existing portable spring blood collection devices.

[0015] (2) By integrating an infrared vascular imaging device, an optical sensing unit, and a machine learning optimization module, intelligent guidance and adaptive control of the puncture process are achieved, moving from two-dimensional planar positioning to three-dimensional spatial interaction. The infrared vascular imaging device provides two-dimensional structural information of subcutaneous blood vessels, while the optical sensing unit integrated into the blood collection needle interprets the backscattered light phase in real time, providing feedback on the three-dimensional mechanical interaction state between the needle tip and the tissue, thereby obtaining depth information of the penetration process. The multimodal fusion control unit synchronizes the event and precise data to the machine learning module at the moment the needle tip enters the cavity to optimize the model. The optimized model can predict personalized puncture parameters based on infrared images. In clinical applications, the system can be simplified to a guidance mode that relies solely on infrared imaging and a pre-trained model, eliminating the need for an optical sensing unit and achieving a high success rate of puncture by automatically adjusting the flying needle parameters. Attached Figure Description

[0016] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0017] Figure 1 This is a schematic diagram of the overall clinical painless flying needle blood collection device in Example 1.

[0018] Figure 2 This is a schematic diagram of the internal structure of the blood collection needle used for model training in Example 2.

[0019] Figure 3 This is a schematic diagram of the optical sensing unit in Embodiment 2.

[0020] Figure 4 This is a schematic diagram of the mounting base and fixing bracket in Embodiment 1.

[0021] Figure 5 This is a cross-sectional schematic diagram of the clinical painless flying needle blood collection device in Example 1.

[0022] Figure 6 This is a schematic diagram of the overall clinical painless flying needle blood collection device in Example 1 (from another angle).

[0023] Figure 7 This is a cross-sectional schematic diagram of the flying needle launcher in Example 3.

[0024] Figure 8 This is a schematic diagram of the operating platform in Example 4.

[0025] Figure descriptions: 1-Collection tube; 2-Collection needle; 3-Flying needle emitter; 31-Button; 32-Fixed bracket; 33-Guide rod; 34-Elastic element; 35-Static interactive magnetic array; 36-Conductor ring; 4-Mounting base; 5-Optical sensing unit; 51-Optical fiber; 52-Gradient refractive index lens; 53-Micromirror array; 54-External integrated unit; 6-Infrared vascular imaging device. Detailed Implementation

[0026] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0027] The concepts involved in this application will first be described with reference to the accompanying drawings. It should be noted that the following descriptions of various concepts are only for the purpose of making the content of this application easier to understand and do not constitute a limitation on the scope of protection of this application; furthermore, the embodiments and features in the embodiments of this application can be combined with each other unless otherwise specified. This application will now be described in detail with reference to the accompanying drawings and embodiments.

[0028] Example 1 like Figure 1 , Figures 4-6 As shown, this embodiment provides a clinical painless flying needle blood collection device, which adopts a modular and detachable design. The device includes a collection tube 1 and a blood collection needle 2 located at the front end of the collection tube. The collection tube 1 is connected to the flying needle launcher 3 via a mounting base 4. The flying needle launcher 3 includes a button 31, a fixing bracket 32, a guide rod 33, and an elastic element 34 sleeved on the guide rod. The elastic element 34 is preferably a pre-compressed spring. The fixing bracket 32 ​​is fixedly connected to the mounting base 4 to ensure the stability of the entire structure.

[0029] This invention provides a clinical painless flying needle blood collection device. Its core working principle is to complete high-speed and precise vascular puncture within the time window of physiological pain transmission through efficient conversion and precise control of mechanical energy, thereby achieving painless or minimally painful blood collection at the physical level.

[0030] Human pain receptors transmit stimulation signals from the skin to the cerebral cortex, generating pain sensation. The typical physiological reaction time is approximately 0.1 to 0.3 seconds. Based on this physiological mechanism, this invention uses the instantaneous release of the elastic element 34 to drive the blood collection needle 2 at extremely high acceleration, ensuring that the entire process from initiation to hitting the target subcutaneous blood vessel takes less than 0.3 seconds, preferably controlled between 0.05 and 0.2 seconds. This high-speed puncture time is significantly shorter than the effective transmission time of the pain signal, allowing the puncture operation to be completed before the nerve endings have triggered and completed the pain signal transmission. This directly avoids pain perception from a physical mechanism perspective, laying the physiological foundation for a painless experience.

[0031] The working process of this invention includes the following steps: Before activation, the elastic element 34 is compressed or stretched by a mechanical structure to store elastic potential energy; after activation, the stored energy is efficiently converted into the linear motion kinetic energy of the guide rod 33 and the blood collection needle 2. In use, the operator adjusts the preload of the preload spring to about 8N through the scale adjustment mechanism, locks it, and presses button 31. The preload spring instantly releases its elastic potential energy, pushing the guide rod 33 and the blood collection needle 2 to move at high speed along a linear trajectory.

[0032] The puncture depth is controlled at around 1.5mm, which is suitable for most superficial veins.

[0033] The device is also equipped with a safety locking mechanism to prevent accidental triggering.

[0034] The flying needle launcher 3 also includes a scale adjustment mechanism coupled to the preload spring, which is used to adjust and lock the preload of the preload spring within the range of 5N to 15N.

[0035] The device employs a high-speed ejection technology of 200-300 mm / s, far exceeding the physiological reaction time of pain nerves (0.3 seconds), ensuring that nerve endings are punctured before pain is perceived. Combined with an ultra-fine blood collection needle (0.2-0.25 mm diameter) and a double-beveled needle tip design, the puncture contact area is reduced by 60% and the cutting area by 35% compared to traditional needles, further minimizing nerve stimulation. A scale adjustment mechanism coupled with a pre-compression spring ensures an ejection speed error of ≤5%, and a puncture depth error of ≤0.05 mm is achieved through stroke limiting, resulting in a puncture success rate of over 99% (compared to ≤88% for existing portable devices), providing precise depth control.

[0036] Example 2 like Figure 2 and Figure 3As shown, this embodiment further integrates an optical sensing unit 5 based on Embodiment 1. This unit not only provides real-time guidance for the puncture process, but its high-precision optical signals and tissue state data are also key data sources for subsequent machine learning model training. The optical sensing unit 5 includes an optical component integrated into the needle tip region of the blood collection needle 2 and an external integrated unit 54 disposed on the outside. The optical component mainly includes an optical fiber 51 extending along the needle tube axis, a gradient refractive index lens 52 fixed at its distal end, and a micro-mirror array 53 distributed around the lens. The external integrated unit 54 includes a light source module, a photoelectric detection module, an interference detection module, and a processing module. In a specific implementation of the present invention, the distal end of the optical fiber 51 of the optical sensing unit 5 is fixed inside the needle tube of the blood collection needle 2 via a spiral path. This design improves the mechanical reliability of the system in a high-speed puncture environment. When the flying needle emitter 3 drives the blood collection needle 2 with extremely high acceleration, the needle body and internal components are subjected to severe impact stress, which tightly winds and fixes the optical fiber 51 in a spiral shape. This effectively disperses the axial inertial impact force and converts it into a continuous radial friction force, preventing the optical fiber 51 from sliding, bending or breaking inside the tube, and ensuring the absolute stability of the optical path connection during high-speed dynamic processes.

[0037] During operation, the probe light emitted by the light source is transmitted via optical fiber 51 to a gradient refractive index lens 52, which shapes the beam into a conical beam with a predetermined divergence angle. A micromirror array 53 splits the beam and directs it in at least two different spatial directions to irradiate the tissue in front of the needle tip. Backscattered light generated after the beams interact with the tissue in each direction is collected and coupled back to optical fiber 51, transmitting it back to the external integrated unit 54. The processing module analyzes the phase fluctuations and other characteristics of the backscattered light to determine the tissue state of the needle tip in real time (e.g., whether it is located in the subcutaneous fat layer, in contact with the blood vessel wall, or has entered the blood vessel lumen).

[0038] Preferably, the gradient refractive index lens 52 is a cylindrical optical element with a parabolic refractive index distribution along the radial direction, and its length is configured to give the emitted beam a divergence angle of 30° to 60°. This parameter design achieves a crucial balance within the needle tip's limited space: a narrow beam less than 30° is difficult to cover the vessel wall and surrounding effective detection area, easily leading to signal loss; a wide beam greater than 60° causes a sharp drop in light energy density due to excessive diffusion and induces aliasing of scattered light from tissues at different depths, weakening axial resolution. The divergence angle of 30° to 60° ensures sufficient illumination coverage while maintaining the axial resolution required for a high signal-to-noise ratio. This conical beam can uniformly illuminate each reflective surface of the micromirror array 53, ensuring the efficiency of multi-channel beam splitting and signal uniformity. During high-speed puncture, this divergence angle forms a dynamic optical detection field with reasonable depth, which can simultaneously capture forward-looking and real-time tissue signals, providing the system with a continuous and smooth flow of status information. This is a key design parameter for achieving high-reliability optical sensing in a high-speed dynamic puncture environment. The gradient refractive index lens 52 is externally covered by a light-transmitting protective cover, which encloses the gradient refractive index lens 52 and / or the micromirror array 53. The modular design of the light-transmitting protective cover enables the optical front end to be cleanable, sterilizable, and replaceable.

[0039] To meet the real-time requirements of high-speed punctures (200-300 mm / s), the optical sensing unit 5 employs the following processing architecture: a 10MHz bandwidth balanced detector coupled with FPGA for real-time demodulation at a demodulation rate of 100 MSPS; multi-channel parallel sampling (250 MSPS, 12-bit); feature extraction and lightweight model inference outputting classification results every 10 μs, corresponding to a state update every 2.5 μm. The multimodal fusion control unit performs fusion analysis based on the real-time tissue state information fed back by the optical sensing unit 5 and the vascular structure information provided by the infrared vascular imaging device 6. When it is determined that the needle tip has entered the vascular lumen, the multimodal fusion control unit triggers a braking command while simultaneously recording the puncture depth and angle data corresponding to that precise moment. These successful puncture data, precisely calibrated by the optical sensing unit, are transmitted to the machine learning optimization module for continuous training and optimization of the puncture parameter prediction model. For example, by analyzing massive amounts of successful puncture data, the machine learning optimization module can establish a nonlinear mapping relationship between vascular imaging features (such as contrast, width, and curvature) and the optimal spring preload. Once the system acquires a new infrared vascular image, the optimized model can output a personalized preload force recommendation value for that vascularity. The multimodal fusion control unit then drives the preload force adjustment mechanism to automatically set the preload force of the flying needle launcher 3 to the target value. This process represents a leap from manual experience-based adjustment to data-driven intelligent pre-setting, ensuring that the kinetic energy of each ejection precisely matches the depth and tissue characteristics of the target vascularity.

[0040] Example 3 like Figure 7 As shown, this embodiment further optimizes the internal structure of the flying needle launcher. A permanent magnet is fixed on the guide rod 33, and a static interactive magnetic array 35 is arranged parallel to its movement path. This array consists of multiple unit magnets with opposite magnetization directions.

[0041] When the guide rod moves at high speed, the permanent magnet interacts with the alternating magnetic field, generating lateral micro-vibrations at a frequency of approximately 500Hz. This enables the blood collection needle to achieve "dynamic cutting," reducing tissue resistance and pain. By introducing a magnetic coupling mechanism, the blood collection needle 2 undergoes high-frequency micro-amplitude vibration during high-speed puncture, improving tissue compatibility and operational precision. This vibration, replacing "static compression" with "dynamic cutting," effectively reduces the peak resistance encountered by the needle tip when penetrating the skin and blood vessel walls, minimizing tissue deformation and continuous pressure stimulation of nerve endings, thereby further enhancing the painless effect at a physical level. Simultaneously, the micro-amplitude vibration helps suppress lateral slippage of blood vessels at the moment of puncture, increasing the success rate of hitting the target blood vessel on the first attempt, especially advantageous for blood vessels with poor elasticity or deep locations. This design is achieved purely mechanically / magnetically, requiring no external power supply or complex control circuitry, ensuring the reliability, compactness, and portability of the device while improving puncture performance.

[0042] To achieve stable lateral vibration with a frequency of approximately 500 Hz and an amplitude of approximately 10 micrometers, the static interactive magnetic array 35 in this embodiment is configured with the following parameters: N52 grade neodymium iron boron rectangular magnets (1.5 mm × 2.0 mm × 5.0 mm) are arranged in a straight line with a spacing of λ = 0.5 mm along the guide rod's movement path, with adjacent magnets having opposite magnetization directions. When the guide rod passes at a speed of v = 250 mm / s, the frequency of the lateral force on the permanent magnet is f = v / λ = 500 Hz. Through finite element magnetic field simulation and dynamic analysis, this force amplitude is optimized to approximately 0.1 N. Under this excitation, the system generates a lateral vibration amplitude of approximately 12 μm. This micro-vibration effectively reduces puncture resistance without observably affecting the straightness of the puncture. The lateral vibration amplitude can also be estimated using dynamic equations: simplifying the guide rod-blood collection needle system to a single-degree-of-freedom spring-mass system, the lateral equivalent stiffness k is determined by the fit clearance between the fixed bracket 32 ​​and the guide rod 33, with a measured value of 8.5 × 10⁻⁶. 3 N / m. Under simple harmonic excitation with an amplitude of 0.1N and a frequency of 500Hz, the steady-state response amplitude is A = F / k·Q, where Q is the system quality factor (measured Q≈10). The calculated value is A≈11.8μm, which is rounded to 12μm in the design.

[0043] A conductor ring 36 is also provided at the end of the guide rod, with its axis coinciding with the axis of motion of the guide rod. When the blood collection needle pierces the blood vessel, the permanent magnet enters the conductor ring area, generating eddy current damping through electromagnetic induction to absorb the remaining kinetic energy and prevent needle tip rebound or secondary damage. At the moment the guide rod 33 drives the permanent magnet to its end at high speed, i.e., the instant the blood collection needle tip pierces the blood vessel, the permanent magnet quickly passes through or approaches the conductor ring 36. The changing magnetic field induces strong eddy currents within the conductor, generating a powerful damping force opposite to the direction of motion. This damping force absorbs the remaining kinetic energy of the needle in a smooth and continuous manner, eliminating needle tip rebound and vibration caused by traditional mechanical collisions, thereby avoiding secondary scratches to the blood vessel wall and significantly reducing the risk of subcutaneous bleeding, bruising, and hematoma. Through optimized configuration of the conductor ring 36's installation position, the timing of the permanent magnet entering its effective area is highly synchronized with the physiological event of the needle tip piercing the blood vessel. This design ensures that the damping force is precisely activated the moment the needle tip breaks through the blood vessel wall, which can absorb the remaining kinetic energy in time and prevent blood vessel damage, while avoiding the impact on puncture speed due to premature damping activation or the inability to suppress the initial rebound due to late activation.

[0044] To address the potential for insufficient damping at low speeds, this invention optimizes the process to ensure sufficient braking force at the critical moment when the needle tip pierces the blood vessel: the installation position of the conductor ring 36 is precisely calibrated so that the starting point of its effective range corresponds to 0.3mm~0.5mm from the needle tip to the anterior wall of the blood vessel. At this point, the guide rod 33 is still in high-speed motion, generating more than 70% of the peak damping force. Simultaneously, a multi-stage conductor ring structure can be employed: 2~3 independent conductor rings 36 are spaced along the movement path of the guide rod 33, with differentiated designs for axial position, inner diameter, material thickness, and conductivity of each conductor ring; the first-stage conductor ring near the starting end uses a thin-walled, high-conductivity material (such as oxygen-free copper, 0.2mm~0.4mm thick) to generate a large initial damping force during the high-speed motion of the guide rod; the intermediate-stage conductor ring uses a medium-thickness material (0.5mm~0.7mm thick) to maintain the damping effect after the speed decreases; and the final conductor ring uses a thick-walled material (0.8mm~1.0mm thick) to enhance the magnetic field coupling efficiency at low speeds. Each conductor ring can be independently connected in series with an adjustable resistor. The multi-modal fusion control unit presets the circuit impedance parameters according to the target puncture depth, so that the damping force remains relatively stable throughout the braking process, ensuring that sufficient braking force can still be generated to absorb the remaining kinetic energy after the needle tip enters the blood vessel.

[0045] Example 4 See Figure 8 This embodiment provides a method for machine learning training and clinical guidance of puncture parameters for a clinical painless flying needle blood collection system. The method includes a model training and configuration stage and a clinical guidance operation stage. During the model training configuration phase, the following steps are performed: (a) A blood collection needle 2 containing an optical sensing unit 5 is assembled on a clinical painless flying needle blood collection system, and an infrared vascular imaging device 6 is activated to form a data acquisition system. (b) Perform multiple puncture tests using the data acquisition system; in each test, simultaneously perform: acquire vascular structure images of the target area through the infrared vascular imaging device 6, perform puncture motion through the flying needle launcher 3, and monitor and record the timing status information of the needle tip passing through different tissue layers in real time through the optical sensing unit 5. (c) Based on the time-series state information recorded by the optical sensing unit 5, determine the precise moment when the needle tip pierces the blood vessel wall and is stably located in the blood vessel lumen, and extract the actual puncture depth value and actual puncture angle value corresponding to that moment; (d) Use the vascular structure images obtained from each experiment as input samples, and use the corresponding actual puncture depth values ​​and actual puncture angle values ​​as labels to form a set of training data; collect multiple sets of the training data to construct a training dataset; (e) Use the training dataset to train a machine learning model that can learn the mapping relationship from vascular structure image features to the optimal puncture depth and angle, and obtain a trained puncture parameter prediction model. During the clinical guidance phase, the following steps are performed: (f) Switch the clinical painless flying needle blood collection system to the working state of equipping a conventional blood collection needle 2 without the optical sensing unit 5, and activate the infrared vascular imaging device 6; (g) Obtain an image of the vascular structure at the puncture site using the infrared vascular imaging device 6; (h) Input the real-time vascular structure image into the puncture parameter prediction model, and the model outputs the recommended puncture depth and recommended puncture angle for the current target; (i) Based on the recommended puncture depth and recommended puncture angle, the operator is guided to adjust the puncture parameters of the flying needle launcher 3 through a visual interface, or the flying needle launcher 3 automatically adapts to the parameters, and then the clinical puncture operation is performed.

[0046] In the clinical painless flying needle blood collection system constructed in this invention, the optical sensing unit 5 is not only a real-time guidance component, but also a key data engine and high-precision calibration source for realizing system intelligence. Its core value lies in transforming the traditional puncture process, which relies on operator experience and fuzzy visual judgment, into a quantifiable, learnable, and reproducible precise physical model. Specifically, during the system's model training and optimization phase, the optical sensing unit 5 integrated into the needle tip captures the backscattered light phase fluctuations caused by the interaction between the needle tip and different tissue layers during high-speed puncture. Through real-time interpretation of these signals, the system can quickly and accurately determine the tissue state of the needle tip—especially the crucial moment of "the needle tip stably entering the blood vessel lumen." Simultaneously, the system records the precise puncture depth and angle corresponding to this moment and aligns it with the vascular structure image acquired by the infrared vascular imaging device 6. Thus, each puncture test generates a set of high-quality training data: the infrared image serves as the input feature, and the "optimal puncture" depth and angle determined by the optical sensing serve as the target label. Through training with a large amount of such data, the machine learning model can establish an accurate mapping relationship from two-dimensional visual features of blood vessels to three-dimensional optimal puncture parameters. In actual use, only the flying needle launcher 3, the blood collection needle 2, and the infrared vascular imaging device 6 with a built-in trained model are required. After the medical staff selects the blood vessel through the infrared image, the system calls up the model in real time and directly outputs the recommended puncture depth and angle, which is presented intuitively in the form of superimposed guide lines. The operator can then perform a high-success-rate puncture by setting it accordingly.

[0047] The embodiments and / or implementation methods described above are merely preferred embodiments and / or implementation methods for implementing the technology of the present invention, and are not intended to limit the implementation methods of the technology of the present invention in any way. Any person skilled in the art may make some modifications to other equivalent embodiments without departing from the scope of the technical means disclosed in the content of the present invention, but these should still be regarded as the technology or embodiments that are substantially the same as the present invention.

[0048] This document uses specific examples to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the methods and core ideas of this application. The above descriptions are only preferred embodiments of this application. It should be noted that due to the limitations of written expression, while there are objectively infinite specific structures, those skilled in the art can make several improvements, modifications, or changes without departing from the principles of this application, and can also combine the above technical features in an appropriate manner. These improvements, modifications, changes, or combinations, or the direct application of the inventive concept and technical solution to other situations without modification, should all be considered within the scope of protection of this application.

Claims

1. A clinical multimodal guided painless flying needle blood collection system, comprising a collection tube (1) and a blood collection needle (2) disposed at the front end of the collection tube (1), characterized in that, The collection tube (1) is connected to the flying needle launcher (3). The flying needle launcher (3) includes a guide rod (33), an elastic element (34) sleeved on the guide rod (33), and a button (31) for actuating the elastic element (34). The flying needle launcher (3) is used to drive the blood collection needle (2) to perform puncture movement. The blood collection needle (2) integrates an optical sensing unit (5). The optical sensing unit (5) includes an optical fiber (51) extending along the axial direction of the blood collection needle (2). The distal end of the optical fiber is fixed in the needle tube of the blood collection needle (2) in a spiral path. A gradient refractive index lens (52) is fixed at the distal end of the optical fiber. A micro-mirror array (53) is distributed circumferentially on the gradient refractive index lens (52).

2. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, The near end of the gradient refractive index lens (52) is optically coupled to the far end of the optical fiber (51), and the length of the gradient refractive index lens (52) is designed such that a light beam input from its near end has a predetermined divergence angle when it reaches its outer peripheral surface. θ , where 30°≤ θ ≤60°; the micro-mirror array (53) includes at least three mirror surfaces that are equally spaced along the circumference of the gradient refractive index lens (52), and the micro-mirror array (53) is used to guide the light signal from the gradient refractive index lens (52) to at least two different spatial directions.

3. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, It also includes an infrared vascular imaging device (6), a multimodal fusion control unit, and a machine learning optimization module. The infrared vascular imaging device (6) is used to acquire structural image information of subcutaneous blood vessels. The multimodal fusion control unit is communicatively connected to the optical sensing unit (5) and the infrared vascular imaging device (6), and is configured to: receive real-time tissue state information from the optical sensing unit (5) and vascular structure information from the infrared vascular imaging device (6); and generate instructions for controlling the flying needle transmitter (3).

4. The clinical multimodal guided painless flying needle blood collection system according to claim 3, characterized in that, The elastic element (34) is a preloaded spring. The flying needle launcher (3) also includes a preload adjustment mechanism coupled to the preloaded spring. The multimodal fusion control unit can control the preload adjustment mechanism to set the preload of the preloaded spring to a target value according to the output of the machine learning optimization module or the operator input.

5. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, A permanent magnet is provided on the guide rod (33), and a static interactive magnetic array (35) parallel to the movement path of the guide rod (33) is provided inside the flying needle launcher (3). The magnetic field direction of the static interactive magnetic array (35) changes alternately along the movement path of the guide rod (33) to interact with the permanent magnet when the guide rod (33) moves, so that the blood collection needle (2) generates high-frequency micro-amplitude vibration.

6. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, It also includes a kinetic energy absorption module, which includes a conductor ring (36) and a permanent magnet on the guide rod (33). When the guide rod (33) moves to the end, the permanent magnet passes through or approaches the conductor ring (36) and generates a damping force to suppress the rebound of the guide rod (33) through electromagnetic induction.

7. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, The optical sensing unit (5) further includes an external integration unit (54), which is connected to the proximal end of the optical fiber (51) via a pluggable connector. The external integration unit (54) includes: a light source module for emitting probe light to the tissue through the optical fiber (51); a photoelectric detection module for receiving backscattered light from the optical fiber (51) and converting it into an electrical signal; an interference detection module for analyzing the optical phase change information contained in the backscattered light; and a processing module for identifying the tissue state based on the phase change information.

8. The clinical multimodal guided painless flying needle blood collection system according to claim 7, characterized in that, The optical sensing unit (5) adopts a single-fiber bidirectional optical path structure. The optical fiber (51) is a single optical fiber, which is used to transmit the probe light to the gradient refractive index lens (52) and to transmit the backscattered light returned from the gradient refractive index lens (52) to the external integrated unit (54).

9. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, It also includes a parameter recording module, which includes: a displacement sensor set on the guide rod (33) for real-time monitoring of the puncture depth of the blood collection needle (2); an attitude sensor set on the flying needle launcher (3) for real-time monitoring of the puncture angle of the blood collection needle (2); and a data synchronization unit, which is connected to the optical sensing unit (5), the displacement sensor and the attitude sensor respectively.

10. The clinical multimodal guided painless flying needle blood collection system according to claim 1, characterized in that, The gradient refractive index lens (52) is a cylindrical optical element, with the central axis of the cylinder coinciding with the central axis of the needle tube of the blood collection needle (2). The refractive index of the gradient refractive index lens (52) is parabolic in the radial direction.

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