Baseline blood oxygen saturation and pulse wave waveform continuous monitoring system and method
By designing a continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform, the problems of dependence on manual operation and lack of standardization in the traditional Allen test were solved. It achieved precise arterial positioning and stable compression without patient cooperation, thus improving the safety and efficiency of the test.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- ZHEJIANG PROVINCIAL PEOPLES HOSPITAL
- Filing Date
- 2026-04-15
- Publication Date
- 2026-05-29
AI Technical Summary
The traditional Allen test relies on manual operation, which is not suitable for patients who cannot cooperate voluntarily. It poses safety risks and has a low degree of standardization, making it difficult to achieve precise arterial positioning and stable compression, thus affecting the reliability and efficiency of the test results.
A baseline blood oxygen saturation and pulse waveform continuous monitoring system was designed, including a wrist fixation unit, an arterial compression unit, a positioning adjustment unit, a compression control unit, and a blood oxygen monitoring module. Through mechanical structure, it achieves wrist fixation, precise arterial positioning, synchronous compression, and real-time monitoring, making it suitable for special populations such as comatose patients and infants, and providing reliable physiological indicator references.
This enables standardized procedures that do not require manual compression, making it suitable for diverse patients, improving the safety and efficiency of the trial, ensuring the standardization of arterial compression and the reliability of monitoring data, and reducing the waste of medical resources.
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Figure CN122096745A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of medical device technology, and in particular to a system and method for continuous monitoring of baseline blood oxygen saturation and pulse wave waveform. Background Technology
[0002] In clinical medicine, the Allen test is a classic method for assessing collateral circulation in the palmar arch of the hand. It is widely used for safety assessments before invasive procedures such as radial artery puncture, catheterization, and interventional surgery. Its core purpose is to avoid postoperative hand ischemia and ensure the safety of medical procedures. Meanwhile, blood oxygen saturation and pulse wave waveforms, as core physiological indicators for assessing human circulatory function, are important auxiliary bases for the objective interpretation of Allen test results. Especially in baseline physiological state monitoring, stable and accurate blood oxygen and pulse wave data can provide a reliable reference for assessing collateral circulation function, further enhancing the scientific rigor of the test results. However, the traditional Allen test uses manual bimanual compression, which is highly dependent on patient cooperation and cannot be applied to patients who are comatose, anesthetized, stroke-paralyzed, or infants and young children who lack the ability to cooperate, posing potential medical safety risks. Furthermore, the procedure has low standardization; the pressure, location, and duration all depend on the operator's experience, resulting in highly subjective and unreliable results. It is also inefficient and consumes valuable medical resources.
[0003] In addition, a similar patent, CN105030217A, discloses a portable motion monitoring device and method. It selects two different wavelengths of red or infrared light as incident light, perpendicularly incident on the finger. One of the incident lights has a wavelength of 805nm infrared light. The pulse wave and blood oxygen concentration are measured using a reflective method. The arterial blood oxygen saturation is calculated by measuring the AC component (IAC) and DC component (IDC) of the reflected light signals from the two different wavelengths of red or infrared light, using a formula. Compared to the transmission method, this reduces baseline drift caused by light dispersion interference and motion interference. It significantly improves accuracy and practicality compared to traditional transmission pulse measurement. This invention improves the accuracy and practicality of monitoring in motion scenarios. However, this solution focuses on portable monitoring during motion and lacks the ability to locate and stabilize arteries such as the radial and ulnar arteries, failing to address the issue of inconsistent manual compression in the traditional Allen test. Furthermore, it lacks a dedicated body position fixation and compression control mechanism, making it difficult to ensure stability during long-term continuous monitoring. Summary of the Invention
[0004] To address the aforementioned technical problems in existing Allen tests, this invention provides a system that stabilizes the patient's wrist and maintains the testing position via a wrist fixation unit, making it suitable for comatose patients, infants, and other patients lacking voluntary cooperation, thus mitigating potential medical risks. The positioning adjustment unit, utilizing a slide rail, scale, and slider locking mechanism, adjusts the distance between the two compression heads to align with the projection points of the radial and ulnar arteries on the body surface. Combined with a flexible contact pad, it standardizes the compression position. The compression control unit enables simultaneous stable compression of both arteries and selective release on one side, improving operational standardization. Furthermore, it integrates a blood oxygen monitoring module to collect real-time blood oxygen saturation and pulse wave data, providing a reliable baseline blood oxygen saturation and pulse wave waveform continuous monitoring system for collateral circulation assessment.
[0005] The device includes a base, and integrated on the base are a wrist fixation unit, an arterial compression unit, a positioning adjustment unit, a compression control unit, and a blood oxygen monitoring module. The wrist fixation unit supports and stabilizes the patient's wrist to maintain the testing position. The arterial compression unit includes two independent compression heads, each with a flexible contact pad at its end, for compressing the radial and ulnar arteries respectively. The positioning adjustment unit includes a transverse slide rail mechanism on the base, with the two compression heads mounted on the slide rail via sliders. The sliders have a locking mechanism, and the slide rails have graduations for adjusting and locking the distance between the two compression heads to align with the surface projection points of the radial and ulnar arteries. The compression control unit includes a synchronous pressure application mechanism, an independent locking and release mechanism, and an anti-accidental contact mechanism to achieve simultaneous and stable compression of both arteries and selective release on one side. The blood oxygen monitoring module is integrated into the inner side of the wrist fixation unit to collect real-time blood oxygen saturation values and pulse wave data of the patient's palm area.
[0006] This invention utilizes a wrist fixation unit to stably support the patient's wrist, ensuring consistent testing positioning without requiring patient cooperation. It is perfectly suited for special populations such as those in a coma, under anesthesia, and infants, completely avoiding the medical safety risks associated with traditional manual operations due to patient non-cooperation. The positioning adjustment unit, employing a transverse slide rail, scale markings, and a slider locking mechanism, allows for flexible adjustment and precise locking of the distance between the two compression heads, ensuring accurate alignment with the radial and ulnar artery projection points. Combined with the flexible contact pads at the ends of the compression heads, this ensures standardized compression positioning and enhances patient comfort. The compression control unit's synchronous pressure application, independent locking and release, and anti-accidental activation mechanisms enable standardized operation of simultaneous stable compression of both arteries and selective release on one side, eliminating reliance on operator experience and significantly improving operational standardization. An integrated blood oxygen monitoring module within the wrist fixation unit collects real-time data on blood oxygen saturation and pulse wave waveforms in the palm area, providing reliable physiological indicators for assessing collateral circulation function and enhancing the scientific rigor and objectivity of the test results. The overall solution eliminates the need for manual compression by both hands, significantly improving operational efficiency and saving medical resources. At the same time, it ensures the stability and continuity of the assessment process, fully adapts to the diverse application scenarios of the clinical Allen test, and provides strong support for the safety assessment before radial artery-related invasive procedures.
[0007] Preferably, the wrist fixation unit for supporting and stabilizing the patient's wrist to maintain the testing position includes:
[0008] The wrist fixation unit first conforms to the palmar and dorsal contours of the patient's wrist through an ergonomic curved structure, forming a comprehensive support structure for the patient's wrist and generating support and fit data that is adapted to the patient's wrist.
[0009] Based on the generated support and fit data, the elastic restraint component of the wrist fixation unit automatically adjusts the tightness of the restraint to keep the patient's wrist in the preset Allen test standard position, generating wrist position fixation data.
[0010] Using the generated wrist position fixation data, the anti-slip limiting component of the wrist fixation unit limits the radial and ulnar sides of the patient's wrist to prevent the patient's wrist from shifting during the test, and generates wrist displacement anti-deviation data.
[0011] In this invention, the wrist fixation unit adopts an ergonomic curved surface structure, conforming fully to the palmar and dorsal contours of the patient's wrist to generate appropriate support and fit data, ensuring both comfort and fit. The elastic restraint component automatically adjusts its tightness based on the fit data, keeping the wrist stably in the standard Allen test position and generating positional fixation data, maintaining a standardized testing posture without requiring active patient cooperation. Anti-slip limiting components further limit the radial and ulnar sides of the wrist, generating anti-deviation data to prevent wrist displacement from affecting test results during the test. This step overcomes the dependence on patient cooperation in traditional manual operation, perfectly adapting to special populations such as those who are comatose, anesthetized, or infants and young children who lack the ability to cooperate independently, completely avoiding the risk of operation interruption or result deviation due to positional changes. Simultaneously, standardized positional fixation ensures consistency of test conditions between different patients and operators, laying the foundation for the reliability of subsequent arterial compression and monitoring data, and improving the standardization and safety of the test.
[0012] Preferably, the two compression heads of the arterial compression unit compress the radial artery and the ulnar artery respectively, including:
[0013] The arterial compression unit first retrieves the compression head spacing locking data generated by the positioning adjustment unit, determines the surface projection positions of the radial and ulnar arteries corresponding to the two compression heads respectively, and generates arterial compression target point positioning data.
[0014] Based on the generated arterial compression target location data, the flexible contact pads of the two compression heads synchronously adhere to the corresponding arterial surface locations, generating contact data between the contact pads and the arterial surface.
[0015] Using the generated contact data, the pressure head applies a preset pressure value to the corresponding artery, so that the blood flow in the radial and ulnar arteries is synchronously blocked, generating arterial blood flow blocking status data.
[0016] In this invention, the arterial compression unit retrieves the spacing locking data from the positioning adjustment unit to precisely determine the surface projection positions of the radial and ulnar arteries, generating compression target point positioning data. This ensures that the compression head can accurately align with the target artery, eliminating reliance on operator experience. The flexible contact pads of the two compression heads synchronously adhere to the corresponding arterial surfaces based on the positioning data, generating contact data to ensure sufficient contact between the compression surface and the artery. The flexible material also enhances patient comfort. The compression heads apply preset pressure to synchronously block blood flow in both arteries, generating blood flow occlusion status data. This avoids experimental errors caused by uneven force and asynchronous occlusion during traditional manual compression. This step overcomes the limitations of similar patents that lack arterial positioning and stable compression structures, achieving standardized and precise control of arterial compression, ensuring consistent bilateral arterial occlusion effects, providing a stable experimental basis for subsequent collateral circulation function assessment, and improving the reliability and objectivity of Allen's test results.
[0017] Preferably, the compression head applies a preset pressure value to the corresponding artery to synchronously block the blood flow in the radial and ulnar arteries, including:
[0018] The compression head first retrieves arterial blood flow occlusion status data, determines the correlation between the current compression pressure and arterial blood flow occlusion, and generates pressure-blood flow occlusion correlation data;
[0019] Based on the generated pressure-blood flow occlusion correlation data, the pressure adjustment component of the compression head gradually increases the compression pressure, monitors the arterial blood flow status in real time, and generates dynamic monitoring data on pressure increase and blood flow changes.
[0020] Using the dynamic monitoring data of pressure increase and blood flow change generated, the compression head adjusts the pressure value to the preset blood flow complete blockage pressure threshold and keeps it stable, generating arterial blood flow blockage status data.
[0021] In this invention, the compression head retrieves blood flow occlusion status data, clarifies the correlation between compression pressure and blood flow occlusion, and generates pressure-blood flow correlation data, providing a scientific basis for pressure adjustment. The pressure adjustment component gradually increases the pressure based on the correlation data, monitors blood flow changes in real time, and generates dynamic monitoring data, accurately capturing the critical state of blood flow occlusion. Accordingly, the pressure is adjusted to a preset complete occlusion threshold and maintained stably, generating blood flow occlusion status data. This ensures complete occlusion of blood flow in the radial and ulnar arteries while avoiding excessive compression that could cause patient discomfort or vascular damage. This step overcomes the limitations of traditional manual compression relying on experience to judge the force, achieving quantitative control and dynamic optimization of blood flow occlusion, and ensuring consistent occlusion effects under different patient vascular conditions. A stable blood flow occlusion state ensures the accuracy of subsequent collateral circulation assessment, reduces the risk of misjudgment due to incomplete occlusion, and further enhances the scientific rigor and clinical safety of the Allen test.
[0022] Preferably, the pressure regulating component of the compression head gradually increases the compression pressure, and real-time monitoring of the arterial blood flow status includes:
[0023] The pressure regulation component first retrieves the generated pressure-blood flow occlusion correlation data, starts the pressure increment program and sets the pressure increment gradient, and generates pressure gradient increment control data.
[0024] Based on the generated pressure gradient incremental control data, the pressure sensor collects the pressure value applied to the arterial surface by the compression head in real time, and generates real-time pressure acquisition data.
[0025] Using the generated real-time pressure acquisition data, the blood flow monitoring module synchronously detects changes in arterial blood flow velocity and volume, generating dynamic monitoring data on pressure increases and blood flow changes.
[0026] In this invention, the pressure regulation component retrieves pressure-blood flow occlusion correlation data, initiates a pressure increment program, and sets a reasonable gradient to generate standardized pressure control data, avoiding sudden pressure increases that could cause patient discomfort or vascular damage. The pressure sensor collects compression pressure values in real time, synchronously linking with the blood flow monitoring module to detect changes in arterial flow velocity and flow rate, generating dynamic correlation data between pressure and blood flow. This allows the operator to clearly understand the correspondence between pressure increment and blood flow occlusion. This step overcomes the limitations of traditional manual compression based solely on experience, achieving visualized and dynamic control of pressure regulation and blood flow status. It ensures accurate capture of the critical pressure for complete blood flow occlusion, avoiding both insufficient pressure leading to incomplete occlusion affecting test results and excessive pressure causing additional damage. Simultaneously, the standardized pressure increment process ensures consistency across different operators and patients, providing a scientific basis for the stable maintenance of subsequent blood flow occlusion and further improving the standardization and reliability of the Allen test results.
[0027] Preferably, the positioning adjustment unit adjusts and locks the distance between the two compression heads to align with the surface projection points of the radial and ulnar arteries, including:
[0028] The positioning adjustment unit first drives the slider to move on the transverse slide rail mechanism according to the size parameters of the patient's wrist, adjusts the distance between the two compression heads, and generates compression head distance adjustment data;
[0029] Based on the generated pressure head spacing adjustment data, the scale markings next to the slide rail accurately calibrate the position of the pressure head, generating pressure head position calibration data;
[0030] Using the generated pressure head position calibration data, the slider locking mechanism locks the position of the pressure head to prevent the spacing from changing during the detection process, generating pressure head spacing lock data.
[0031] In this invention, the positioning and adjustment unit drives a slider to flexibly move along a transverse slide rail based on the patient's wrist size parameters, adjusting the spacing between the compression heads and generating spacing adjustment data suitable for different patients, thus achieving personalized compression position adaptation. The position of the compression heads is calibrated using scale markings next to the slide rail, generating precise positional data that allows the compression heads to accurately align with the surface projection points of the radial and ulnar arteries, eliminating reliance on operator experience. The slider locking mechanism locks the compression head position based on the calibration data, generating spacing locking data to prevent compression failure due to spacing deviation during testing. This step establishes a standardized positioning and adjustment process, overcoming the shortcomings of traditional manual compression positioning, such as ambiguity and easy deviation, ensuring the accuracy and stability of bilateral arterial compression target points. Regardless of the size difference between patients' wrists, precise adjustment and locking ensure consistent compression positions, laying the foundation for subsequent synchronous and stable compression, and significantly improving the adaptability and operational standardization of the experiment.
[0032] Preferably, the synchronous pressure application mechanism of the compression control unit achieves synchronous and stable compression of both arteries by:
[0033] The synchronous pressure application mechanism first receives the pressure head spacing locking data generated by the positioning adjustment unit, determines the initial position of the two pressure heads, and generates pressure head initial position confirmation data;
[0034] Based on the generated initial position confirmation data of the compression head, the lever-link system of the synchronous pressure application mechanism drives the two compression heads to press down synchronously and vertically through a single driving action, generating synchronous downward pressure driving data of the compression heads;
[0035] Using the generated synchronous pressing drive data of the pressure head, the synchronous pressing mechanism controls the stroke and force of the pressing to keep the pressure applied by the two pressure heads consistent, thus generating pressure synchronization control data.
[0036] In this invention, the synchronous pressure application mechanism receives the locking data of the distance between the pressure heads, confirms the initial position, and generates position confirmation data to ensure consistent pressure initiation benchmarks. Utilizing a lever-link system, a single drive action achieves synchronous vertical pressure from both pressure heads, generating synchronous drive data and avoiding differences in the timing and stroke of pressure on both sides during manual operation. Simultaneously, precise control of the pressure stroke and force ensures consistent pressure applied by both pressure heads, generating pressure synchronization control data and achieving synchronous occlusion of bilateral arterial blood flow. This step overcomes the limitations of similar patents lacking stable pressure structures, completely eliminating the subjective differences in manual pressure and achieving standardized and synchronized control of the pressure action. Bilateral pressure balance ensures consistent blood flow occlusion effects, avoiding misjudgments in collateral circulation assessment due to incomplete occlusion on one side. It also simplifies the operation process, allowing for precise pressure without the need for two-person collaboration, improving operational efficiency, saving medical resources, and adapting to the diverse testing needs of clinical patients.
[0037] Preferably, the lever-link system of the synchronous pressure application mechanism drives the two pressure heads to press down synchronously and vertically through a single driving action, including:
[0038] The lever-link system first retrieves the synchronous downward pressure drive data of the pressure head, starts the drive component and transmits the drive force to the lever assembly, and generates drive force transmission data;
[0039] Based on the generated driving force transmission data, the lever assembly converts the driving force into a vertically downward pressure and transmits it to the linkage structure, generating force direction conversion data;
[0040] Using the generated force direction conversion data, the linkage structure drives the two compression heads to move downward synchronously, so that the compression heads gradually come into contact with the surface of the artery, generating synchronous downward pressure drive data for the compression heads.
[0041] In this invention, a lever-link system retrieves synchronous downward pressure drive data, activates the drive component, and stably transmits the drive force to the lever assembly, generating precise drive force transmission data to ensure lossless and unbiased transmission. The lever assembly converts the drive force into vertically downward pressure and transmits it to the linkage structure, generating standardized force direction conversion data to avoid interference from lateral forces on compression accuracy. The linkage structure drives the two compression heads to move synchronously downward, achieving gradual contact with the arterial surface and generating stable synchronous downward pressure data. This step overcomes the limitation of traditional manual double-hand compression in achieving synchronous movement, achieving synchronous vertical downward pressure from both compression heads through a single drive action, ensuring that the timing and stroke of bilateral arterial compression are completely consistent, laying the foundation for subsequent pressure equalization control. Simultaneously, the standardized force transmission and conversion process eliminates reliance on operator experience, improves the standardization and stability of compression movements, avoids inconsistent compression effects due to differences in movement, further enhances the reliability of Allen test results, and adapts to the diverse testing needs of clinical patients.
[0042] Preferably, the linkage structure drives the two compression heads to move downwards synchronously, so that the compression heads gradually come into contact with the surface of the artery, including:
[0043] The linkage structure first retrieves the force direction conversion data, controls the two pressure heads to move downwards according to the preset motion trajectory, and generates pressure head motion trajectory control data;
[0044] Based on the generated motion trajectory control data of the compression head, the flexible contact pad of the compression head first contacts the patient's skin and gradually conforms to the surface of the artery, generating skin contact data of the contact pad;
[0045] Using the generated skin contact data, the linkage structure continues to drive the compression head down to the preset initial compression position, so that the compression head gradually contacts the arterial surface, generating synchronous compression head down pressure drive data.
[0046] In this invention, a linkage structure retrieves force direction conversion data and controls the compression head to move downwards along a preset trajectory, generating precise motion trajectory control data to ensure smooth and controllable movement of the compression head, avoiding deviation or wobbling. The flexible contact pad of the compression head first contacts the skin and gradually conforms to the arterial surface, generating conformation data. Utilizing the cushioning properties of the flexible material reduces skin irritation during the initial compression, improving patient comfort. Based on the conformation data, the compression continues to the preset initial compression position, generating stable synchronous compression drive data, achieving a smooth transition from contact to initial compression. This step overcomes the pain points of traditional manual compression, which easily leads to uneven force and patient discomfort. Through progressive conformation and trajectory control, the contact between the compression head and the arterial surface is gentler and more fully conformed. At the same time, the standardized motion trajectory and conformation process ensures consistency in the compression contact process for different patients, avoiding the impact of differences in contact methods on the accuracy of subsequent pressure adjustment, providing a guarantee for the stability of blood flow occlusion, and further improving the standardization of the test and patient compliance.
[0047] Preferably, the independent locking and releasing mechanism of the compression control unit enables selective release of the unilateral compression head by including:
[0048] The independent locking and releasing mechanism first receives pressure synchronization control data. When the pressure head is pressed down to the working position, it triggers the pawl assembly to engage with the ratchet rack of the pressure head support rod, generating pressure head locking status data.
[0049] Based on the generated compression head locking status data, the independent locking and release mechanism detects the trigger signals of the two release buttons, determines the side of the compression head that needs to be released, and generates release side determination data;
[0050] Using the generated release side determination data, the release button on the corresponding side is triggered to disengage the pawl from the ratchet rack, and the corresponding pressure head automatically pops up under the action of the return spring, generating single-side pressure head release status data;
[0051] Based on the generated data on the release status of the unilateral compression head, the compression head on the unreleased side remains locked, maintaining compression on the corresponding artery, thus generating data on continuous unilateral arterial compression.
[0052] In this invention, an independent locking and release mechanism receives pressure synchronization control data. When the compression head reaches the working position, the pawl assembly engages with the ratchet rack to lock, generating reliable locking status data. This ensures stable pressure maintenance and prevents pressure decay or compression head displacement during testing. The release side is determined by detecting the release button trigger signal, generating precise release side determination data for accurate unilateral release control. Triggering the corresponding side release button disengages the pawl, and the compression head automatically springs back under the action of the return spring, generating clear unilateral release data. The unreleased side remains locked to maintain pressure, generating stable unilateral continuous compression data. This step overcomes the limitations of traditional manual compression, which requires continuous force from both hands, and the risk of accidental release on the other side. It achieves precise unilateral selective release after simultaneous compression of both arteries, perfectly matching the core process requirement of "double compression followed by single release" in the Allen test. Simultaneously, the mechanical locking and automatic release mechanism eliminates the subjectivity of manual operation, ensuring reliable locking and accurate release, avoiding test interruptions or misjudgments due to operational errors, improving the convenience and safety of test operations, and providing crucial assurance for accurate assessment of collateral circulation function.
[0053] Preferably, the independent locking and releasing mechanism detects the trigger signals of the two release buttons to determine which side of the pressure head needs to be released, including:
[0054] The independent locking and releasing mechanism first retrieves the release side determination data, monitors the voltage signal changes of the two release buttons in real time, and generates button trigger signal monitoring data;
[0055] Based on the generated button trigger signal monitoring data, compare it with the preset button trigger threshold to determine whether there is a valid trigger signal and generate trigger signal validity determination data;
[0056] Using the generated trigger signal validity determination data, determine the release button side corresponding to the valid trigger signal and generate release side determination data.
[0057] In this invention, the independent locking and releasing mechanism retrieves release side identification data, monitors the voltage signal changes of the two release buttons in real time, and generates monitoring data to ensure real-time capture of trigger actions. Based on a preset trigger threshold, the validity of the signal is compared and judged, generating validity identification data. This filters out invalid signals such as accidental touches and jitter, avoiding release side errors caused by operational mistakes. Based on this, the side corresponding to the valid trigger signal is determined, and release side identification data is generated, providing a clear basis for subsequent accurate release. This step overcomes the limitations of traditional manual compression relying entirely on experience to determine the release side, constructing a standardized signal monitoring and judgment process, achieving accurate identification and reliable determination of the release side. Regardless of the operator's skill level, objective signal analysis ensures accurate release side identification, avoiding confusion in the experimental process or misjudgment of results due to side identification errors. It also improves operational convenience, reduces the waste of medical resources caused by repetitive operations, and provides precise side identification control for the core process of Allen's experiment: double pressure followed by single release.
[0058] Preferably, triggering the release button on the corresponding side causes the pawl to disengage from the rack, and the corresponding pressing head automatically springs up under the action of the return spring, including:
[0059] The independent locking and releasing mechanism first retrieves the release side determination data, triggers the release button to drive the pawl assembly to retract, and generates pawl retraction drive data;
[0060] Based on the generated pawl contraction drive data, the pawl disengages from the ratchet rack to release the lock on the compression head support rod, generating compression head lock release data;
[0061] Using the generated data on the locking and unlocking of the pressure head, the reset spring releases its elastic potential energy, causing the pressure head to move upward, thus generating data on the reset motion of the pressure head.
[0062] Based on the generated compression head reset motion data, the compression head returns to its initial position to release the compression on the corresponding artery, generating unilateral compression head release status data.
[0063] In this invention, the independent locking and releasing mechanism retrieves release-side determination data and precisely drives the corresponding side's pawl assembly to contract, generating drive data to ensure accurate unlocking of the locking mechanism. The pawl disengages from the ratchet rack, releasing the lock on the compression head support rod and generating lock release data, reliably terminating the compression state. The return spring releases elastic potential energy, driving the compression head upwards and generating return motion data, allowing the compression head to smoothly return to its initial position, completely releasing pressure on the corresponding artery and generating clear release state data. This step overcomes the limitations of similar patents that lack a stable compression release structure, eliminates the subjective differences during manual compression release, and achieves standardized and mechanized control of unilateral compression release. The release process is smooth and controllable, avoiding patient discomfort due to excessively rapid release and preventing incomplete release from affecting the monitoring effect of collateral circulation blood flow recovery. Simultaneously, the non-released side remains locked, ensuring continuous pressure on the other artery, perfectly meeting the requirements of the Allen test procedure and further improving the standardization of the test operation and the reliability of the results.
[0064] Preferably, the method of releasing elastic potential energy by the reset spring to drive the pressing head to move upward includes:
[0065] The reset spring first retrieves the locking release data of the pressure head, releases the stored elastic potential energy and generates an upward driving force, thus generating spring driving force data;
[0066] Based on the generated spring driving force data, the driving force drives the pressure head support rod to move upward, generating support rod motion data;
[0067] Using the generated support rod motion data, the compression head moves according to the preset reset trajectory, generating compression head reset trajectory data;
[0068] Based on the generated compression head reset trajectory data, it is detected whether the compression head has reached the preset initial position, and compression head reset motion data is generated.
[0069] In this invention, the reset spring retrieves the locking release data, releases the stored elastic potential energy, and generates an upward driving force, producing spring driving force data to provide stable power support for the reset movement. The driving force drives the pressure head support rod upward, generating support rod motion data to ensure smooth transmission of the reset power. The pressure head moves along a preset reset trajectory and generates trajectory data, preventing deviation or jamming during the reset process and ensuring smooth movement. By detecting whether the pressure head has reached the preset initial position, reset motion data is generated to ensure proper reset, providing assurance for subsequent operations or device return to its original position after the experiment. This step overcomes the limitation of traditional manual release where the pressure head lacks a standardized reset path, constructing a standardized reset process that achieves stable, accurate, and controllable pressure head reset. A stable reset process not only avoids discomfort caused by the pressure head colliding with the patient but also ensures the consistency of the device's state after reset, facilitating continuous testing on different patients and improving device reusability and operational efficiency. Simultaneously, accurate reset provides an accurate benchmark for the next pressure positioning, further strengthening the standardization and stability of the entire experimental process.
[0070] Preferably, the anti-accidental activation mechanism of the pressure control unit to prevent accidental activation of the release button during detection includes:
[0071] The anti-accidental touch mechanism first retrieves the reset motion data of the pressure head, forms a physical partition between the two release buttons, and generates button physical isolation data;
[0072] Based on the generated button physical isolation data, the logic control component of the anti-accidental touch mechanism restricts the triggering conditions of the release button, setting that the release button can only be triggered after synchronous compression is completed, and generating button triggering logic restriction data;
[0073] Using the generated button trigger logic limit data, the anti-accidental touch mechanism monitors the trigger status of the release button in real time. When an unexpected trigger signal is detected, an alarm is issued, generating accidental touch alarm data.
[0074] In this invention, the anti-accidental touch mechanism retrieves the resetting motion data of the compression head and generates isolation data by placing a physical partition between the two release buttons, spatially blocking accidental touches and preventing the triggering of non-target buttons due to hand shaking or accidental contact during operation. The logic control component further restricts the triggering conditions of the release buttons, setting them to be triggered only after synchronous compression is completed, generating logical restriction data to avoid operational errors of premature release from the process. Simultaneously, the button triggering status is monitored in real time, and an alarm prompt is issued and alarm data is generated when an unexpected signal is detected, promptly reminding the operator to correct the error. This step overcomes the limitations of traditional manual operation lacking accidental touch protection, constructing a triple anti-accidental touch system of physical isolation, logical control, and alarm prompts, ensuring that the release operation strictly conforms to the experimental procedure requirements. Regardless of the operator's skill level, the risk of misoperation can be reduced through objective protection mechanisms, ensuring the continuity and stability of the experimental procedure, avoiding the waste of medical resources due to repeated operations caused by accidental touches, and further improving the operational safety and result reliability of the Allen test.
[0075] Preferably, the present invention also provides a method for continuous monitoring of baseline blood oxygen saturation and pulse waveform. This method is implemented based on the baseline blood oxygen saturation and pulse waveform continuous monitoring system described above. The method includes the following steps:
[0076] S01: Place the patient's wrist in the wrist fixation unit, which supports, restrains, and limits the wrist, generating wrist position fixation data.
[0077] S02: Adjust the distance between the two pressure heads by adjusting the positioning adjustment unit, mark the position with the scale marks and then lock the slider to generate pressure head distance locking data;
[0078] S03: Activate the synchronous pressure application mechanism of the compression control unit, drive the two compression heads to press down synchronously and apply the preset pressure, so as to synchronously block the blood flow of the radial artery and ulnar artery and generate arterial blood flow blockage status data;
[0079] S04: Start the blood oxygen monitoring module to collect the baseline blood oxygen saturation value and pulse wave waveform of the patient's palm area and generate baseline physiological monitoring data;
[0080] S05: Passively simulates a fist-clenching blood-dripping action for patients without the ability to cooperate voluntarily. After completion, the ulnar artery side release button is triggered to relieve the ulnar artery compression and generate unilateral artery compression release data.
[0081] S06: Real-time collection of blood oxygen saturation values and pulse waveforms in the palm area via the blood oxygen monitoring module to generate real-time physiological monitoring data;
[0082] S07: Compare the generated real-time physiological monitoring data with the baseline physiological monitoring data to determine whether the blood oxygen saturation has returned to the baseline level and whether the pulse wave waveform has returned to normal within a preset time, and generate Allen test result judgment data;
[0083] S08: Based on the generated test results, determine the data, output a side circulation function evaluation report, and complete the entire Allen test process.
[0084] This invention utilizes wrist fixation, compression head positioning and locking, and synchronous compression to block blood flow, generating standardized body position and compression data to ensure consistent initial experimental conditions and eliminate reliance on operator experience. A blood oxygen monitoring module is activated to collect baseline physiological data, providing a reliable reference for subsequent result comparison and enhancing the scientific rigor of the assessment. A passive simulated fist-clenching blood-expelling action is designed for patients without voluntary cooperation, overcoming the limitations of traditional tests on patient autonomy and making it suitable for special populations such as those in a coma, under anesthesia, and infants, thus avoiding potential medical safety risks. Real-time physiological data is continuously collected after unilateral release, and compared with baseline data to determine the recovery of blood oxygen and pulse wave, generating objective experimental results data that replace subjective judgment based on traditional manual observation, improving the reliability of the results. Finally, a collateral circulation assessment report is output, forming a complete standardized process. This step establishes a fully automated and standardized Allen test system, overcoming the limitations of similar patents that lack arterial localization and stable compression structures. It not only ensures the standardization of the test and the objectivity of the results, but also improves operational efficiency, saves medical resources, and perfectly adapts to the diverse testing needs of clinical patients, providing strong support for safety assessment before radial artery-related invasive procedures.
[0085] The present invention has the following specific beneficial effects:
[0086] (1) By placing the patient's wrist in the wrist fixation unit, its ergonomic curved structure provides all-around support. The elastic restraint component automatically adjusts the tightness to maintain the wrist in the standard test position, and the anti-slip limiting component further restricts radial and ulnar displacement, ultimately generating complete wrist position fixation data. This step completely eliminates the dependence on patient cooperation in traditional manual operation. Even special populations such as those who are comatose, anesthetized, or infants and young children who lack the ability to cooperate independently can maintain a standardized position through mechanical fixation, avoiding risks such as test interruption and result deviation caused by patient agitation or inability to cooperate. At the same time, the standardized position fixation process ensures the consistency of test conditions between different patients and different operators, avoiding errors caused by the randomness of position in manual operation, laying the foundation for subsequent precise arterial positioning, synchronous compression, and stable monitoring, and greatly improving the operational standardization and applicability of the Allen test.
[0087] (2) The positioning adjustment unit can flexibly drive the slider to move on the transverse slide rail according to the patient's wrist size difference, adjust the distance between the two compression heads, and then complete the position calibration with the help of the scale markings next to the slide rail. Finally, the slider is locked by the locking mechanism to generate accurate compression head distance locking data. This step breaks through the limitation of traditional manual compression that relies solely on experience to judge the artery position, realizes the visualization and standardized positioning of the compression target point, and ensures that the two compression heads can be accurately aligned with the surface projection points of the radial and ulnar arteries, avoiding compression failure or accidental compression of other blood vessels due to positioning deviation. The stable locking mechanism prevents the distance deviation during the test, ensuring the consistency of the compression position. No matter how large the difference in the patient's wrist size, it can achieve precise adaptation through personalized adjustment, providing a key guarantee for subsequent synchronous and stable compression, and improving the adaptability and operational reliability of the test.
[0088] (3) After activating the synchronous pressure application mechanism of the compression control unit, the lever-linkage system drives the two compression heads to press down vertically synchronously through a single drive action, precisely applying the preset pressure to achieve synchronous blockage of blood flow in the radial and ulnar arteries, generating clear arterial blood flow blockage status data. This step completely eliminates the pain point of inconsistent force and rhythm when manually applying pressure with both hands, avoiding situations where blood flow blockage is incomplete due to insufficient pressure on one side, or discomfort is caused by excessive pressure on one side. The standardized pressure application process ensures the consistency of compression effect among different operators, achieving stable blood flow blockage without relying on operator experience. At the same time, it simplifies the operation process, allowing a single person to complete synchronous compression of both arteries without the need for two-person collaboration, greatly improving operational efficiency, saving valuable medical resources, and providing a core guarantee for the accuracy of subsequent baseline physiological data collection.
[0089] (4) After simultaneous occlusion of blood flow in the radial and ulnar arteries, the blood oxygen monitoring module is activated to collect baseline blood oxygen saturation values and pulse waveforms in the palm region, generating complete baseline physiological monitoring data. This step compensates for the shortcomings of traditional manual tests that rely solely on visual observation of hand color changes, providing an objective reference standard for assessing collateral circulation function using quantified physiological indicators. Stable baseline data can accurately reflect the patient's baseline circulatory status before occlusion, avoiding misjudgments due to individual differences in basic physiological characteristics. At the same time, the blood oxygen monitoring module is integrated into the inner side of the wrist fixation unit, close to the palm monitoring area, ensuring the stability of data acquisition. This overcomes the limitations of similar patents that focus on motion monitoring and are difficult to adapt to the baseline monitoring requirements of the Allen test, providing a reliable benchmark for subsequent real-time data comparison and objective judgment of test results, and enhancing the scientific validity and persuasiveness of the test results.
[0090] (5) For patients who are comatose or anesthetized and unable to clench their fists voluntarily, a passive simulation of clenching the fist to expel blood is designed to ensure that the blood in the hand is fully drained. Then, the release button on the ulnar artery side is precisely triggered to relieve the ulnar artery compression and generate unilateral artery compression release data. This step overcomes the core pain point of the traditional Allen test, which relies on the patient's voluntary fist clenching to expel blood. It completes the blood expulsion process through mechanical assistance, achieving effective adaptation for special populations and avoiding the risk of incomplete blood drainage due to the patient's inability to clench their fist, which in turn affects the collateral circulation assessment results. At the same time, the unilateral release operation is based on the pre-locked compression head position and is precisely executed through independent locking and release mechanisms, avoiding the situation of accidentally pressing the release button on the other side during manual operation. This ensures that only the ulnar artery compression is relieved and the radial artery is maintained in a occluded state, perfectly meeting the core process requirement of the Allen test of first applying double pressure and then releasing unilaterally, thus improving the standardization and safety of the operation.
[0091] (6) After the ulnar artery compression is relieved, the blood oxygen monitoring module continuously and in real time collects the blood oxygen saturation value and pulse waveform of the palm area, generating dynamic real-time physiological monitoring data. This step breaks through the subjective limitations of traditional manual tests that rely solely on visual observation of the recovery of hand color, and realizes the quantitative and visual monitoring of the circulatory function recovery process. Real-time data can accurately capture the trend of blood oxygen saturation recovery and the details of pulse waveform changes, avoiding misjudgments caused by individual visual differences and untimely observation in manual observation. At the same time, the monitoring module is integrated into a fixed unit and maintains stable contact with the wrist, ensuring the continuity and stability of data acquisition, overcoming the shortcomings of similar patents that cannot guarantee the stability of long-term continuous monitoring. Continuous real-time data provides rich dynamic evidence for subsequent comparison with baseline data, making the assessment of collateral circulation function more scientific and objective.
[0092] (7) The real-time physiological monitoring data is systematically compared with the baseline physiological monitoring data. Quantitative Allen test result judgment data is generated based on two core dimensions: whether blood oxygen saturation recovers to the baseline level within a preset time and whether the pulse wave waveform returns to normal. This step completely eliminates the subjective experience-based judgment mode of traditional manual tests, which judges the test as qualified simply by the recovery of hand color. Through the quantitative comparison of objective physiological indicators, the judgment criteria for test results are clarified, avoiding differences in results caused by different operators using different interpretation standards. The setting of preset time thresholds further standardizes the judgment process, ensuring the consistency of results. At the same time, it can accurately identify situations of insufficient collateral circulation function, such as slow recovery of blood oxygen and failure of the pulse wave to return to normal, effectively avoiding the risk of postoperative hand ischemia caused by misjudgment in traditional tests. Quantitative judgment data makes the test results more convincing and provides a reliable basis for clinical diagnosis and treatment decisions.
[0093] (8) Based on the test results, determine the data and output an assessment report containing core information such as baseline data, real-time data comparison results, and collateral circulation function level, completing the entire process. This step constructs a complete closed-loop management of the test, breaking through the limitations of traditional manual tests that rely solely on verbal notification or simple written records. The standardized report format facilitates data archiving, retrieval, and traceability, meeting the requirements of standardized management of clinical medical documents. The assessment report clearly presents the key data of each stage of the test, enabling medical staff to quickly grasp the patient's collateral circulation function status and providing a comprehensive basis for the safety assessment of invasive procedures such as radial artery puncture and catheterization. At the same time, the complete process record facilitates subsequent medical quality control and academic research, enhancing the clinical application value of the Allen test. This step further strengthens the standardization and normalization of the test, ensuring the traceability and authority of the test results, and providing the ultimate guarantee for ensuring the safety of medical operations. Attached Figure Description
[0094] Other features, objects, and advantages of the invention will become more apparent from the following detailed description of non-limiting embodiments with reference to the accompanying drawings:
[0095] Figure 1 This is a schematic diagram of the baseline blood oxygen saturation and pulse wave waveform continuous monitoring system of the present invention;
[0096] Figure 2 This is a detailed flowchart illustrating the steps of the continuous monitoring method for baseline blood oxygen saturation and pulse wave waveform of the present invention. Detailed Implementation
[0097] The present invention will be further described below with reference to the accompanying drawings and embodiments, but this should not be construed as limiting the present invention.
[0098] To achieve the above objectives, please refer to Figure 1This invention provides a baseline blood oxygen saturation and pulse wave waveform continuous monitoring system, including a base, and a wrist fixation unit, an arterial compression unit, a positioning adjustment unit, a compression control unit, and a blood oxygen monitoring module integrated on the base. The wrist fixation unit supports and stabilizes the patient's wrist to maintain the detection position. The arterial compression unit includes two independent compression heads, each with a flexible contact pad at its end for compressing the radial and ulnar arteries respectively. The positioning adjustment unit includes a transverse slide rail mechanism on the base, with the two compression heads mounted on the slide rail via sliders. The sliders have a locking mechanism, and the slide rails have graduations for adjusting and locking the distance between the two compression heads to align with the surface projection points of the radial and ulnar arteries. The compression control unit includes a synchronous pressure application mechanism, an independent locking and release mechanism, and an anti-accidental contact mechanism to achieve synchronous and stable compression of both arteries and selective release on one side. The blood oxygen monitoring module is integrated into the inner side of the wrist fixation unit to collect real-time blood oxygen saturation values and pulse wave waveform data of the patient's palm area. The entire system is powered by DC5V / 1A. The system uses a 2.4-inch LCD to display SpO2, pulse wave, pressure and status in real time. The system uses Bluetooth BLE5.0 or USB communication and locally stores 1000 sets of test data in a loop.
[0099] In this embodiment of the invention, the core of the system is a base made of ABS engineering plastic. The base integrates all mechanical transmission components internally and has an externally molded structure adapted to wrist placement, providing a foundation for the installation and support of each functional unit. The wrist fixation unit is a concave wrist rest molded on top of the base. The curved surface of the wrist rest conforms to the anatomical curve of the human wrist, stabilizing the patient's wrist through a fully enclosed support structure and maintaining the required position for testing. The arterial compression unit includes two independently arranged compression heads. Each compression head has a detachable flexible contact pad made of medical-grade silicone material at its end. The surface of the contact pad has an anti-slip texture to ensure close contact with the skin during compression and to avoid skin damage. The positioning adjustment unit consists of a transverse linear slide rail mechanism, a slider, and a locking mechanism. The slide rail is fixed to the top of the base, and precise scale markings are engraved next to the slide rail. The two compression heads slide in conjunction with the slide rail via the slider. A rotary locking knob is located on the side of the slider. The knob is linked to an internal friction pad; tightening it allows the slider to fit tightly against the slide rail for locking. By moving the slider and aligning with the scale markings, the distance between the two compression heads can be adjusted to accurately align with the surface projection points of the radial and ulnar arteries. The compression control unit integrates a synchronous pressure application mechanism, an independent locking and release mechanism, and an anti-accidental activation mechanism. The synchronous pressure application mechanism includes a downward linkage rod hinged to the rear of the base and symmetrical connecting rods, enabling synchronous downward pressure from both compression heads. The independent locking and release mechanism consists of a ratchet rack, a spring pawl, and independent release buttons on both sides, enabling locking and releasing of one compression head. The anti-accidental activation mechanism is a physical partition located between the two release buttons. The blood oxygen monitoring module is integrated on the inner side of the concave wrist rest, corresponding to the thenar eminence of the palm. It adopts a reflective monitoring structure. The module is connected to the control circuit board on the side of the base via wires. The circuit board integrates signal processing and display components for real-time acquisition and display of blood oxygen saturation values and pulse waveform data.
[0100] In addition, the baseline blood oxygen saturation and pulse wave waveform continuous monitoring system includes a base, and a wrist fixation unit, an arterial compression unit, a positioning adjustment unit and a compression control unit integrated on the base. The wrist fixation unit supports and stabilizes the patient's wrist, maintaining the testing position. The arterial compression unit includes two independent compression heads with flexible contact pads at their ends, used to compress the radial and ulnar arteries respectively to increase patient comfort and ensure proper compression. The positioning adjustment unit includes a transverse slide rail mechanism on the base. The two compression heads are mounted on the slide rail via sliders with locking mechanisms. A scale is provided next to the slide rail to adjust and lock the distance between the two compression heads, ensuring precise alignment with the surface projection points of the radial and ulnar arteries near the radial styloid process and ulnar styloid process. The compression control unit is the core of the baseline oxygen saturation and pulse wave waveform continuous monitoring system, including: a synchronous pressure application mechanism using a mechanical linkage design, such as a lever-linkage system, where a single driving action pushes down the linkage lever to drive the two compression heads to synchronously and vertically press down, applying stable and sufficient pressure to both arteries to achieve synchronous blood flow occlusion, with a compression pressure range of 30-100 kPa; and an independent locking and release mechanism, with a ratchet rack on the support rod of each compression head and a spring-driven pawl at a corresponding position within the base. When the compression head is pressed down to the working position, the pawl engages with the ratchet teeth to achieve self-locking, thereby maintaining the compression state. Each pawl is connected to an independent release button, corresponding to the radial artery side and the ulnar artery side respectively. Triggering the release button on a specific side disengages the pawl on that side from the ratchet teeth, and the corresponding compression head automatically springs up under the action of the internal return spring, releasing the compression, while the compression head on the other side remains locked, thus achieving selective unilateral release. An anti-accidental touch mechanism is provided, with a physical partition between the two release buttons, or designed in the operation logic to prevent accidental activation of the wrong release button in critical steps. A blood oxygen saturation monitoring module can also be integrated. This module includes an optical probe, which adopts a reflective blood oxygen detection probe similar to that of smartwatches and phone watches, miniaturized and integrated into a specific position of the wrist fixation unit, such as the inner side of the wrist rest corresponding to the thenar or hypothenar eminence of the palm, so that it can naturally conform to the skin surface after the wrist is fixed. A processing and display unit can be integrated into the system body or connected to external devices via wired / wireless means to process photoelectric signals, calculate and display blood oxygen saturation values and pulse wave volume waveforms in real time. After integration, the workflow is upgraded to the following: once the patient's wrist is immobilized, the integrated optical probe automatically contacts the skin and begins continuous monitoring of baseline blood oxygen saturation and pulse wave waveform. The operator drives the synchronous pressure mechanism to compress both arteries, and the monitoring module displays the disappearance or significant attenuation of the pulse wave waveform, objectively confirming that blood flow is effectively blocked. After assisting the patient or passively simulating a fist-clenching action for those who are unable to do so, the operator triggers the unilateral release mechanism—the ulnar artery side.The observation and monitoring module displays whether the pulse wave waveform recovers within a set time, such as 10 seconds, or whether the blood oxygen saturation returns to the baseline. This serves as an objective criterion for the Allen test results, replacing the traditional subjective color observation.
[0101] Furthermore, the wrist fixation unit, used to support and stabilize the patient's wrist to maintain the testing position, includes:
[0102] The wrist fixation unit first conforms to the palmar and dorsal contours of the patient's wrist through an ergonomic curved structure, forming a comprehensive support structure for the patient's wrist and generating support and fit data that is adapted to the patient's wrist.
[0103] Based on the generated support and fit data, the elastic restraint component of the wrist fixation unit automatically adjusts the tightness of the restraint to keep the patient's wrist in the preset Allen test standard position, generating wrist position fixation data.
[0104] Using the generated wrist position fixation data, the anti-slip limiting component of the wrist fixation unit limits the radial and ulnar sides of the patient's wrist to prevent the patient's wrist from shifting during the test, and generates wrist displacement anti-deviation data.
[0105] In this embodiment of the invention, the wrist fixation unit achieves support and stability through a concave wrist rest molded on an ABS engineering plastic base. The curved surface of the concave wrist rest strictly matches the anatomical curves of the palmar and dorsal sides of an adult wrist. The curvature of the surface is gradually designed along the longitudinal direction of the wrist, conforming to the contour of the area from the wrist joint to the palm base, forming a fully enclosed support structure. When the wrist is placed in the wrist rest, the curved surface is in full contact with the wrist skin. The mechanical feedback generated by the contact and fit generates support and fit status data. Based on this data, the elastic restraint straps integrated on both sides of the concave wrist rest begin to move. The elastic restraint straps are made of medical-grade elastic rubber. Through the built-in mechanical linkage mechanism, the restraint straps are pulled towards the wrist and tightened. During the tightening process, the degree of fit is sensed through the mechanical contact points on the inside of the restraint straps until the wrist is fixed in the Allen test standard position, that is, the wrist joint is naturally extended, the palm is slightly relaxed, and the radial and ulnar artery pulsation points are fully exposed. At this time, the mechanical linkage mechanism locks the position of the restraint straps, forming wrist position fixation data. Based on this fixed data, the rigid plastic limiting blocks set at both ends of the concave wrist support move towards the radial and ulnar sides of the wrist simultaneously. The inner side of the limiting block conforms to the lateral contour of the wrist and forms a cooperative limiting structure with the curved surface of the concave wrist support, preventing the wrist from shifting left and right or sliding forward and backward during the test. The locking state of the limiting block forms wrist displacement anti-deviation data, ensuring the continuous stability of the test position.
[0106] Furthermore, the two compression heads of the arterial compression unit respectively compress the radial artery and the ulnar artery, including:
[0107] The arterial compression unit first retrieves the compression head spacing locking data generated by the positioning adjustment unit, determines the surface projection positions of the radial and ulnar arteries corresponding to the two compression heads respectively, and generates arterial compression target point positioning data.
[0108] Based on the generated arterial compression target location data, the flexible contact pads of the two compression heads synchronously adhere to the corresponding arterial surface locations, generating contact data between the contact pads and the arterial surface.
[0109] Using the generated contact data, the pressure head applies a preset pressure value to the corresponding artery, so that the blood flow in the radial and ulnar arteries is synchronously blocked, generating arterial blood flow blocking status data.
[0110] In this embodiment of the invention, the two compression heads of the arterial compression unit retrieve compression head spacing locking data generated by the positioning adjustment unit. This data is determined by a slider locking position on a linear slide rail. After the slider slides along the graduated linear slide rail, it is fixed by a mechanical latch. The locked spacing directly corresponds to the distance between the radial and ulnar artery projection positions on the body surface. Based on this, the precise positioning points of the two compression heads are determined, forming arterial compression target point positioning data. Based on this positioning data, the replaceable silicone pads at the ends of the two compression heads are simultaneously applied to the corresponding arterial body surface positions. The silicone pads are made of soft medical-grade silicone material with an anti-slip texture on the surface. During the application process, the mechanical pressure contacts built into the compression heads sense the contact state between the silicone pads and the skin, ensuring that the silicone pads completely cover the arterial body surface projection area, forming contact data. Using this contact data, a linkage rod is driven by a downward pressure lever with a 1:1 ratio and a total stroke of 15mm. This allows the two pressure heads to overcome the weak preload of the internal springs and apply pressure to the corresponding arteries. During pressure transmission, the downward pressure amplitude is controlled by the meshing structure between the ratchet on the pressure head support rod and the spring pawl in the base, until the blood flow in the radial and ulnar arteries is synchronously blocked. At this point, the ratchet and pawl are fully engaged and self-locked, maintaining the current pressure state and forming arterial blood flow blocking status data. Simultaneously, the integrated blood oxygen monitoring probe provides real-time feedback that the pulse wave waveform has disappeared, confirming the blood flow blocking effect.
[0111] Furthermore, the compression head applies a preset pressure value to the corresponding artery to synchronously block the blood flow in the radial and ulnar arteries, including:
[0112] The compression head first retrieves arterial blood flow occlusion status data, determines the correlation between the current compression pressure and arterial blood flow occlusion, and generates pressure-blood flow occlusion correlation data;
[0113] Based on the generated pressure-blood flow occlusion correlation data, the pressure adjustment component of the compression head gradually increases the compression pressure, monitors the arterial blood flow status in real time, and generates dynamic monitoring data on pressure increase and blood flow change; the blood flow complete occlusion threshold is 60-80 kPa, and the pressure increase gradient is 5 kPa / step;
[0114] Using the dynamic monitoring data of pressure increase and blood flow change generated, the compression head adjusts the pressure value to the preset blood flow complete blockage pressure threshold and keeps it stable, generating arterial blood flow blockage status data.
[0115] In this embodiment of the invention, the compression head retrieves pre-generated arterial blood flow occlusion status data. This data includes the mechanical locking position corresponding to the current compression pressure and the pulse wave signal status fed back by the blood oxygen probe. The correspondence between the two clarifies the relationship between the current compression pressure and arterial blood flow occlusion, forming pressure-blood flow occlusion correlation data. Based on this correlation data, the pressure adjustment component gradually increases the compression pressure by adjusting the engagement position of the ratchet and spring pawl on the compression head support rod. During the adjustment process, the blood oxygen monitoring probe synchronously acquires a pulse wave waveform signal once for each ratchet increment, recording the change in pulse wave amplitude during the pressure increase, thus forming dynamic monitoring data on pressure increase and blood flow changes. Using this dynamic monitoring data, the position of the ratchet is continuously adjusted until the pulse wave waveform fed back by the blood oxygen monitoring probe completely disappears and maintains a flat baseline. At this point, the current pressure value is determined to have reached the pressure threshold for complete blood flow occlusion. Pressure locking is achieved through the precise engagement of the spring pawl and the ratchet, maintaining this pressure state and ensuring continuous occlusion of blood flow in the radial and ulnar arteries. The pulse wave signal fed back by the blood oxygen probe and the pressure locking position data are collected again to generate the final arterial blood flow occlusion status data, providing benchmark data for subsequent monitoring after unilateral release of pressure.
[0116] Furthermore, the pressure regulating component of the compression head gradually increases the compression pressure, and real-time monitoring of the arterial blood flow status includes:
[0117] The pressure regulation component first retrieves the generated pressure-blood flow occlusion correlation data, starts the pressure increment program and sets the pressure increment gradient, and generates pressure gradient increment control data.
[0118] Based on the generated pressure gradient increment control data, the pressure sensor collects the pressure value applied to the arterial surface by the compression head in real time, generating real-time pressure acquisition data; the pressure sensor has a range of 0-150 kPa and an accuracy of ±1 kPa.
[0119] Using the generated real-time pressure acquisition data, the blood flow monitoring module synchronously detects changes in arterial blood flow velocity and volume, generating dynamic monitoring data on pressure increases and blood flow changes.
[0120] In this embodiment of the invention, the pressure regulating component first retrieves the generated pressure-blood flow occlusion correlation data, which includes the correspondence between past pressure values and blood flow occlusion states. Based on this, a pressure increment program is initiated. A fixed pressure increment gradient is set through the meshing structure of the ratchet and spring pawl on the compression head support rod. The effective stroke of the compression head is 8-12 mm, and the ratchet tooth pitch is 1 mm. Each rotation of the ratchet tooth pitch corresponds to a fixed pressure increment, forming pressure gradient increment control data. Based on this control data, the pressure sensor integrated inside the silicone pad of the compression head begins to collect the pressure value applied by the compression head to the arterial surface in real time. The pressure sensor transmits pressure information through the signal generated by mechanical deformation, ensuring that the collected pressure data is completely synchronized with the actual pressure applied by the compression head, generating real-time pressure acquisition data. Using the real-time pressure data, a reflective blood flow monitoring module embedded in the concave wrist rest corresponding to the thenar eminence of the palm is simultaneously activated. It senses changes in arterial blood flow velocity and volume through photoelectric signals. When pressure increases, causing a change in blood flow, the photoelectric signal changes accordingly. The monitoring module correlates the pressure data with the corresponding blood flow signal changes, generating dynamic monitoring data on pressure increases and blood flow changes. This data is fed back to the system's display module in real time, providing a basis for determining whether blood flow is blocked.
[0121] Furthermore, the positioning adjustment unit adjusts and locks the distance between the two compression heads to align with the surface projection points of the radial and ulnar arteries, including:
[0122] The positioning adjustment unit first drives the slider to move on the transverse slide rail mechanism according to the size parameters of the patient's wrist, adjusts the distance between the two compression heads, and generates compression head distance adjustment data;
[0123] Based on the generated pressure head spacing adjustment data, the scale markings next to the slide rail accurately calibrate the position of the pressure head, generating pressure head position calibration data;
[0124] Using the generated pressure head position calibration data, the slider locking mechanism locks the position of the pressure head to prevent the spacing from changing during the detection process, generating pressure head spacing lock data.
[0125] In this embodiment of the invention, the positioning adjustment unit first extracts wrist size parameters based on the support and fit data formed when the patient's wrist is placed on the concave wrist support. Based on these parameters, it drives the sliders connected to the bottom of the two compression heads to translate along a transverse linear slide rail mechanism. The sliders and slide rail achieve smooth movement through precise sliding cooperation. During translation, the two compression heads move closer or further apart, thereby adjusting the distance between them and generating compression head distance adjustment data. Based on this distance adjustment data, the scale markings engraved next to the slide rail accurately calibrate the current position of the compression heads. The minimum division value of the scale markings ensures the accuracy of the compression head position calibration. The current distance is determined by reading the scale values aligned with the sides of the compression heads, generating compression head position calibration data. Using this position calibration data, the mechanical locking mechanism on the side of the slider activates. By rotating the locking knob, the internal friction pad is pushed to fit tightly against the slide rail. Friction prevents any displacement of the slider on the slide rail, firmly locking the position of the compression heads and preventing changes in distance due to external force or vibration during detection. This generates compression head distance locking data, providing positional assurance for subsequent precise arterial compression.
[0126] Furthermore, the synchronous pressure application mechanism of the compression control unit achieves synchronous and stable compression of both arteries by including:
[0127] The synchronous pressure application mechanism first receives the pressure head spacing locking data generated by the positioning adjustment unit, determines the initial position of the two pressure heads, and generates pressure head initial position confirmation data;
[0128] Based on the generated initial position confirmation data of the compression head, the lever-link system of the synchronous pressure application mechanism drives the two compression heads to press down synchronously and vertically through a single driving action, generating synchronous downward pressure driving data of the compression heads;
[0129] Using the generated synchronous pressing drive data of the pressure head, the synchronous pressing mechanism controls the stroke and force of the pressing to keep the pressure applied by the two pressure heads consistent, thus generating pressure synchronization control data.
[0130] In this embodiment of the invention, the synchronous pressure applying mechanism first receives the pressure head spacing locking data generated by the positioning adjustment unit. The data confirms that the two pressure heads are in fixed positions aligned with the projection points of the radial and ulnar arteries on the body surface, without any offset or loosening, generating initial position confirmation data for the pressure heads. Based on this initial position confirmation data, the lever-link system of the synchronous pressure applying mechanism begins to operate. The downward linkage pressure rod, hinged to the rear of the base, acts as a single driving component. When subjected to downward pressure, the driving force is evenly transmitted to the support rods of the two pressure heads through two symmetrical connecting rods connected below the pressure rod, driving the two pressure heads to press down synchronously in the vertical direction. The connection points between the connecting rods, pressure rods, and pressure heads are hinged to ensure no offset during the transmission of driving force, generating synchronous downward pressure driving data for the pressure heads. Vertical guidance and limiting ensure no swaying or jamming. Using this synchronous downward pressure drive data, the ratchet on the compression head support rod cooperates with the spring pawl in the base to precisely control the downward stroke and force. The evenly distributed tooth pitch of the ratchet ensures that the downward stroke of the two compression heads is completely consistent, thus keeping the pressure applied by both the compression heads the same. At the same time, the elastic preload of the spring pawl provides stable support for the pressure, avoids pressure fluctuations, generates pressure synchronization control data, and achieves synchronous and stable compression of the radial and ulnar arteries.
[0131] Furthermore, the lever-link system of the synchronous pressure application mechanism drives the two pressure heads to press down synchronously and vertically through a single driving action, including:
[0132] The lever-link system first retrieves the synchronous downward pressure drive data of the pressure head, starts the drive component and transmits the drive force to the lever assembly, and generates drive force transmission data;
[0133] Based on the generated driving force transmission data, the lever assembly converts the driving force into a vertically downward pressure and transmits it to the linkage structure, generating force direction conversion data;
[0134] Using the generated force direction conversion data, the linkage structure drives the two compression heads to move downward synchronously, so that the compression heads gradually come into contact with the surface of the artery, generating synchronous downward pressure drive data for the compression heads.
[0135] In this embodiment of the invention, the lever-link system first retrieves the synchronous downward pressure drive data of the pressure head. This data clarifies the activation threshold and driving force transmission path of the driving component. Based on this, a single driving component, the downward linkage pressure rod hinged to the rear of the base, is activated. When the driving component is subjected to a downward force, the driving force is transmitted to the lever assembly through the hinge point between the pressure rod and the base. The input end of the lever assembly is rigidly connected to the downward linkage pressure rod, ensuring lossless transmission of the driving force and generating driving force transmission data. Based on this driving force transmission data, the lever assembly converts the input driving force into a vertically downward pressure through the lever arm amplification principle. The output end of the lever assembly is hinged to the top of two symmetrically arranged connecting rods. The hinge point uses a precision bearing design to reduce transmission resistance, accurately transmitting the vertically downward pressure to the connecting rod structure, completing the conversion of the force from the horizontal to the vertical direction, and generating force direction conversion data. Using the force direction conversion data, the two connecting rods synchronously transmit vertical pressure to the corresponding compression head support rod. The connection point between the connecting rod and the compression head support rod is designed to be coaxial, ensuring that the two compression heads move downward synchronously in the vertical direction. During the movement, the compression head is always aligned with the preset arterial surface projection point, gradually approaching and contacting the arterial surface, generating synchronous downward pressure drive data for the compression head, ensuring the synchronicity and accuracy of dual artery compression.
[0136] Furthermore, the linkage structure drives the two compression heads to move downwards synchronously, gradually bringing the compression heads into contact with the arterial surface, including:
[0137] The linkage structure first retrieves the force direction conversion data, controls the two pressure heads to move downwards according to the preset motion trajectory, and generates pressure head motion trajectory control data;
[0138] Based on the generated motion trajectory control data of the compression head, the flexible contact pad of the compression head first contacts the patient's skin and gradually conforms to the surface of the artery, generating skin contact data of the contact pad;
[0139] Using the generated skin contact data, the linkage structure continues to drive the compression head down to the preset initial compression position, so that the compression head gradually contacts the arterial surface, generating synchronous compression head down pressure drive data.
[0140] In this embodiment of the invention, the linkage structure first retrieves the force direction conversion data and, combined with the initial position confirmation data of the compression head, sets a vertically downward linear motion trajectory. The rigid connection between the linkage and the compression head support rod controls the two compression heads to move strictly along the preset trajectory, avoiding lateral deviation, thus generating compression head motion trajectory control data. Based on this motion trajectory control data, the replaceable silicone pad at the end of the compression head, acting as a flexible contact pad, first contacts the patient's wrist skin. The softness of the silicone pad causes it to deform slightly upon contact, conforming to the curvature of the skin surface. Simultaneously, the anti-slip texture on the surface of the silicone pad increases its adhesion to the skin. The mechanical deformation feedback generated by the contact generates contact pad skin adhesion data. Using this contact pad skin adhesion data, the linkage structure continues to drive the compression head to slowly press down along the vertical trajectory until the compression head moves to the preset initial compression position. At this point, the silicone pad completely covers the artery surface projection area, forming a uniform contact pressure surface, avoiding excessive local pressure that could damage the skin. Simultaneously, it ensures comprehensive and stable contact between the compression head and the artery surface, generating synchronous downward pressure drive data for the compression head, laying the foundation for subsequent precise application of compression pressure.
[0141] Furthermore, the independent locking and release mechanism of the compression control unit enables selective release of the unilateral compression head, including:
[0142] The independent locking and releasing mechanism first receives pressure synchronization control data. When the pressure head is pressed down to the working position, it triggers the pawl assembly to engage with the ratchet rack of the pressure head support rod, generating pressure head locking status data.
[0143] Based on the generated compression head locking status data, the independent locking and release mechanism detects the trigger signals of the two release buttons, determines the side of the compression head that needs to be released, and generates release side determination data;
[0144] Using the generated release side determination data, the release button on the corresponding side is triggered to disengage the pawl from the ratchet rack. The corresponding pressure head automatically springs up under the action of the return spring, generating single-side pressure head release status data; the return spring's restoring force is 3-5N.
[0145] Based on the generated data on the release status of the unilateral compression head, the compression head on the unreleased side remains locked, maintaining compression on the corresponding artery, thus generating data on continuous unilateral arterial compression.
[0146] In this embodiment of the invention, the independent locking and releasing mechanism first receives pressure synchronization control data. When it detects that the pressure head has been pressed down to a preset working position and the pressure has reached the initial pressure threshold, it triggers the synchronous action of two sets of spring pawl assemblies in the base. Under the action of spring preload, the pawls engage with the tooth grooves of the ratchet rack on the pressure head support rod. Mechanical self-locking is achieved through the meshing of the pawls and the ratchet rack, fixing the pressure head in the current working position and generating pressure head locking status data. Based on this pressure head locking status data, the independent locking and releasing mechanism continuously monitors the trigger signals of the radial and ulnar sides of the two independent release buttons on the system. Mechanical contacts are provided at the bottom of the release buttons. When the button is pressed, the contacts close to generate a trigger signal. The mechanism determines the side of the pressure head that needs to be released by identifying the corresponding circuit of the closed contacts and generates release side determination data. Using this release side determination data, when the release button on the corresponding side is triggered, the internal transmission rod pushes the spring pawl on that side to overcome the preload and disengage from the ratchet rack groove, releasing the self-locking state. The corresponding compression head automatically springs up vertically under the elastic restoring force of the return spring, disengaging from the arterial surface, generating unilateral compression head release status data. Based on this unilateral compression head release status data, the release button on the other side, which has not been triggered, remains in its initial state. The corresponding spring pawl remains engaged and locked with the ratchet rack, and the compression head remains in the working position, continuously applying stable pressure to the corresponding artery, generating unilateral arterial continuous compression data, thus achieving precise control of unilateral release and unilateral continuous compression.
[0147] Furthermore, the independent locking and releasing mechanism detects the trigger signals of the two release buttons to determine which side of the pressure head needs to be released, including:
[0148] The independent locking and releasing mechanism first retrieves the release side determination data, monitors the voltage signal changes of the two release buttons in real time, and generates button trigger signal monitoring data;
[0149] Based on the generated button trigger signal monitoring data, compare it with the preset button trigger threshold to determine whether there is a valid trigger signal and generate trigger signal validity determination data;
[0150] Using the generated trigger signal validity determination data, determine the release button side corresponding to the valid trigger signal and generate release side determination data.
[0151] In this embodiment of the invention, the independent locking and releasing mechanism first retrieves the release side identification data and initiates signal monitoring of the two independent release buttons on the radial and ulnar sides of the system. The bottom of each release button integrates a mechanical contact and a signal transmission component. In the untriggered state, the contact remains open, and the signal transmission component outputs a stable reference voltage signal. During monitoring, the voltage signal fluctuations are captured in real time, generating button trigger signal monitoring data. Based on this monitoring data, the internal signal comparison module compares the real-time voltage signal with a preset button trigger threshold. The trigger threshold corresponds to the voltage signal characteristics when the contact is closed. When the monitored voltage signal drops below the threshold and remains stable, a valid trigger signal is determined to exist. If the signal fluctuation does not reach the threshold or is only momentary, it is determined to be an invalid signal, generating trigger signal validity identification data. Using this validity identification data, the signal positioning module identifies the transmission circuit path corresponding to the valid trigger signal, determining whether the trigger signal originates from the radial or ulnar release button, thereby clarifying the side of the pressure head that needs to be released and generating release side identification data, providing precise direction for subsequent targeted unlocking operations.
[0152] Furthermore, the triggering of the release button on the corresponding side causes the pawl to disengage from the ratchet rack, and the corresponding pressing head automatically springs up under the action of the return spring, including:
[0153] The independent locking and releasing mechanism first retrieves the release side determination data, triggers the release button to drive the pawl assembly to retract, and generates pawl retraction drive data;
[0154] Based on the generated pawl contraction drive data, the pawl disengages from the ratchet rack to release the lock on the compression head support rod, generating compression head lock release data;
[0155] Using the generated data on the locking and unlocking of the pressure head, the reset spring releases its elastic potential energy, causing the pressure head to move upward, thus generating data on the reset motion of the pressure head.
[0156] Based on the generated compression head reset motion data, the compression head returns to its initial position to release the compression on the corresponding artery, generating unilateral compression head release status data.
[0157] In this embodiment of the invention, the independent locking and releasing mechanism first retrieves the release side determination data. After identifying the side of the pressure head that needs to be released, it triggers the release button on the corresponding side through the internal transmission link. When the release button is pressed, it pushes the transmission rod to move towards the pawl assembly. The wedge-shaped structure at the end of the transmission rod squeezes the tail of the pawl, driving the pawl to overcome the preload of the internal spring and contract away from the ratchet rack, generating pawl contraction drive data. Based on this contraction drive data, the meshing teeth at the front end of the pawl gradually disengage from the tooth groove of the ratchet rack on the pressure head support rod. The mechanical self-locking state originally achieved through meshing is released, and the pressure head support rod is no longer constrained by the pawl, generating pressure head locking release data. Using this locking release data, the return spring fitted at the bottom of the pressure head support rod loses the pressure constraint of the pawl and begins to release the pre-stored elastic potential energy. The elastic potential energy is converted into an upward driving force, pushing the pressure head support rod to move upward in the vertical direction. The support rod drives the pressure head at the top to move synchronously, generating pressure head reset motion data. Based on the reset motion data, the compression head continues to move upward along the vertical trajectory until the limiting block at the bottom of the support rod contacts the limiting platform inside the base. At this time, the compression head returns to the initial height position, and the flexible contact pad at the end completely detaches from the surface of the artery, relieving the compression effect on the corresponding artery and generating unilateral compression head release status data.
[0158] Furthermore, the release of elastic potential energy by the reset spring to drive the pressure head upward includes:
[0159] The reset spring first retrieves the locking release data of the pressure head, releases the stored elastic potential energy and generates an upward driving force, thus generating spring driving force data;
[0160] Based on the generated spring driving force data, the driving force drives the pressure head support rod to move upward, generating support rod motion data;
[0161] Using the generated support rod motion data, the compression head moves according to the preset reset trajectory, generating compression head reset trajectory data;
[0162] Based on the generated compression head reset trajectory data, it is detected whether the compression head has reached the preset initial position, and compression head reset motion data is generated.
[0163] In this embodiment of the invention, the return spring first retrieves the locking release data of the compression head. After confirming that the pawl has completely disengaged from the ratchet rack and the limiting constraint of the compression head support rod has been released, it begins to release the elastic potential energy stored during the previous compression process. The elastic potential energy is converted into an upward driving force along the axial direction of the compression head support rod. The driving force acts directly on the force-bearing end face at the bottom of the support rod, generating spring driving force data. Based on this driving force data, the upward driving force overcomes the weight of the compression head itself and the frictional resistance during the movement, driving the compression head support rod to move upward along the guide rail inside the base. The guide rail adopts a precision sliding fit structure, restricting the support rod to move only in the vertical direction to avoid lateral deviation, generating support rod motion data. Using this support rod motion data, the compression head, driven by the support rod, strictly follows the trajectory defined by the guide rail to reset upward. The trajectory completely coincides with the trajectory of the previous downward movement, ensuring that the compression head does not interfere with other components during the reset process, generating compression head reset trajectory data. Based on the reset trajectory data, the limit detection component integrated on the top of the guide rail monitors the position of the support rod in real time. When the limit block at the bottom of the support rod contacts the limit platform, the detection component confirms that the pressure head has reached the preset initial position through the feedback signal generated by the mechanical contact. This position confirmation information is integrated with the reset motion process data to generate the pressure head reset motion data, thus completing the closed-loop confirmation of the reset process.
[0164] Furthermore, the anti-accidental activation mechanism of the pressure control unit to prevent accidental activation of the release button during detection includes:
[0165] The anti-accidental touch mechanism first retrieves the reset motion data of the pressure head, forms a physical partition between the two release buttons, and generates button physical isolation data;
[0166] Based on the generated button physical isolation data, the logic control component of the anti-accidental touch mechanism restricts the triggering conditions of the release button, setting that the release button can only be triggered after synchronous compression is completed, and generating button triggering logic restriction data;
[0167] Using the generated button trigger logic limit data, the anti-accidental touch mechanism monitors the trigger status of the release button in real time. When an unexpected trigger signal is detected, an alarm is issued, generating accidental touch alarm data.
[0168] In this embodiment of the invention, the anti-accidental touch mechanism first retrieves the resetting motion data of the pressure head. After confirming that the pressure head is in its initial position or has completed synchronous pressure locking, the physical partition between the two release buttons remains in its initial state. This partition is made of rigid plastic, is higher than the top of the release buttons, and its width completely covers the gap between the two buttons, forming a physical barrier to prevent fingertips from touching both buttons simultaneously during operation, generating button physical isolation data. Based on this physical isolation data, the logic control component of the anti-accidental touch mechanism is linked to the locking state of the synchronous pressure mechanism and sets the trigger condition: the release button's trigger transmission link is only in a conductive state when the downward linkage rod of the synchronous pressure mechanism is fully depressed, the pawl and ratchet are fully engaged and locked, and the pressure head is in the working pressure position. If this condition is not met, the transmission rod at the bottom of the release button is blocked by the limit block and cannot push the pawl assembly to move, generating button trigger logic restriction data. Using this trigger logic to limit data, the status monitoring component of the anti-accidental touch mechanism monitors the position of the release button and the continuity of the transmission link in real time. When the trigger condition is not met but a pressing action is detected on the release button, the monitoring component triggers the audible and visual prompt component on the side of the base through mechanical transmission to issue an alarm prompt. At the same time, it locks the further pressing action of the release button through the internal linkage to prevent the release of pressure caused by accidental touch, and generates accidental touch alarm prompt data to ensure that the detection process is carried out according to the preset procedure and to avoid the impact of misoperation on the detection results. That is, the release button only enters the effective trigger state after the dual arteries are synchronously compressed and locked. When an unexpected trigger is detected, the audible and visual alarm is immediately activated and the button is mechanically locked to prevent accidental release.
[0169] For further details, please refer to Figure 2 Embodiment 2 of the present invention also provides a method for continuous monitoring of baseline blood oxygen saturation and pulse waveform. The method is implemented based on the baseline blood oxygen saturation and pulse waveform continuous monitoring system described above. The method for continuous monitoring of baseline blood oxygen saturation and pulse waveform includes the following steps:
[0170] S01: Place the patient's wrist in the wrist fixation unit, which supports, restrains, and limits the wrist, generating wrist position fixation data.
[0171] In this embodiment of the invention, the patient's wrist is placed within a concave wrist rest formed on a base. The curved surface of the wrist rest conforms to the anatomical curves of the palmar and dorsal sides of the wrist, forming a fully enclosed support. Mechanical feedback generated by the contact and contact produces support and fit data. Based on this data, medical elastic rubber restraints on both sides of the wrist rest are tightened through a built-in mechanical linkage mechanism. Mechanical contacts on the inner side of the restraints sense the degree of fit until the wrist is fixed in a standard position with the wrist joint naturally extended and the radial and ulnar artery pulsation points fully exposed. The mechanical linkage mechanism locks the position of the restraints, generating wrist position fixation data. Simultaneously, the rigid plastic limiting blocks at both ends of the wrist rest move towards the radial and ulnar sides of the wrist, forming a cooperative limiting with the curved surface of the wrist rest to prevent wrist displacement. The locking state of the limiting blocks generates wrist displacement prevention data, ensuring continuous stability of the detected position.
[0172] S02: Adjust the distance between the two pressure heads by adjusting the positioning adjustment unit, mark the position with the scale marks and then lock the slider to generate pressure head distance locking data;
[0173] In this embodiment of the invention, based on the patient's wrist size parameters, the sliders at the bottom of the two compression heads are pushed to move along the transverse linear slide rail at the top of the base. The sliders and the slide rail work precisely to achieve smooth movement, causing the compression heads to move closer or further apart to adjust the spacing. The side positions of the compression heads are precisely calibrated using the scale markings engraved next to the slide rail, generating compression head position calibration data. After confirming that the spacing matches the surface projection distance between the radial and ulnar arteries, the locking knob on the side of the slider is rotated, pushing the internal friction pad to fit tightly against the slide rail. Friction locks the slider position, preventing spacing changes during detection and generating compression head spacing locking data, providing positional assurance for precise arterial compression.
[0174] S03: Activate the synchronous pressure application mechanism of the compression control unit, drive the two compression heads to press down synchronously and apply the preset pressure, so as to synchronously block the blood flow of the radial artery and ulnar artery and generate arterial blood flow blockage status data;
[0175] In this embodiment of the invention, the synchronous pressure application mechanism of the compression control unit is activated, pressing down the linkage pressure rod hinged to the rear of the base. The pressure rod transmits the driving force evenly to the two pressure head support rods through two symmetrical connecting rods below. The hinged design of the connecting rods, pressure rods, and pressure heads ensures that the driving force is transmitted vertically, causing the two pressure heads to press down synchronously and vertically. The flexible silicone contact pads at the ends of the pressure heads gradually conform to the surface projection areas of the radial and ulnar arteries. The downward pressure amplitude is controlled by the meshing structure between the ratchet on the pressure head support rod and the spring pawl inside the base until the applied pressure reaches a preset threshold, achieving synchronous occlusion of blood flow in the radial and ulnar arteries. At this time, the pawl and ratchet are fully engaged and self-locking to maintain stable pressure. At the same time, the blood oxygen monitoring module reports the disappearance of the pulse wave waveform, integrating the pressure lock-in state and blood flow occlusion signal to generate arterial blood flow occlusion state data.
[0176] S04: Start the blood oxygen monitoring module to collect the baseline blood oxygen saturation value and pulse wave waveform of the patient's palm area and generate baseline physiological monitoring data;
[0177] In this embodiment of the invention, after arterial blood flow is blocked, a reflective blood oxygen monitoring module integrated on the inner side of the concave wrist brace corresponding to the thenar eminence of the palm is activated. The module collects blood oxygen saturation values and pulse wave waveforms in the palm area through photoelectric signals. The monitoring module converts the photoelectric signals into recognizable physiological data and transmits them to the control circuit board on the side of the base. The signal processing component on the circuit board filters and reduces noise on the data to generate stable baseline blood oxygen saturation values and pulse wave waveform data, i.e., baseline physiological monitoring data. This data is simultaneously displayed on the display component integrated on the circuit board, providing a benchmark for subsequent comparisons.
[0178] The blood oxygen monitoring module employs reflective photoplethysmography (PPG) technology. The module incorporates at least two light-emitting diodes (LEDs) of different wavelengths, including red light at 660nm and infrared light at 940nm, along with a photodetector. During operation, the LEDs sequentially emit light towards the palm tissue, and the photodetector receives the reflected light signal. This light signal contains a periodic variation component caused by arterial blood pulsation (AC component) and a constant component caused by absorption by tissue and venous blood (DC component). The signal processing component on the control circuit board first amplifies and filters the received raw PPG signal to remove high-frequency noise and baseline drift. Subsequently, a waveform analysis algorithm identifies the peaks and troughs of the pulse wave, calculates the instantaneous heart rate, and extracts complete pulse wave data for real-time display.
[0179] Blood oxygen saturation is calculated based on a modified formula of Lambert-Beer's law. The signal processing component extracts the AC and DC components of two wavelength light signals respectively. The reflective blood oxygenation module uses 660nm red light and 940nm infrared light. The photoplethysmography signal extracts the AC and DC components and calculates their ratio R=(AC... 660 / DC 660 )÷(AC 940 / DC 940 ),
[0180] Finally, using the preset empirical calibration curve SpO2=A−B×R, where A and B are constants obtained through clinical trials, the ratio R is converted into a real-time blood oxygen saturation value. Through the above signal processing and calculation process, stable baseline physiological monitoring data and real-time physiological monitoring data are generated.
[0181] S05: Passively simulates a fist-clenching blood-dripping action for patients without the ability to cooperate voluntarily. After completion, the ulnar artery side release button is triggered to relieve the ulnar artery compression and generate unilateral artery compression release data.
[0182] In this embodiment of the invention, for patients without voluntary cooperation, the wrist fixation unit, equipped with a finger support structure, passively flexes the metacarpophalangeal joints 3-5 times, holding each flexion for 1 second, completing the blood-draining action of the palm. This pushes the patient's palm to repeatedly clench and relax, promoting venous return in the palm and making the palm paler more noticeable. After the blood-draining is completed, the release button on the ulnar artery side is triggered. The mechanical contact at the bottom of the button closes, generating a trigger signal. This signal, transmitted through an internal transmission rod, pushes the spring pawl on the ulnar artery side to overcome the preload and disengage from the ratchet rack, releasing the lock on the support rod of the ulnar artery side compression head. The ulnar artery side compression head springs upward under the elastic restoring force of the return spring, disengaging from the ulnar artery surface and relieving pressure. The release action and the pressure relief state are integrated to generate unilateral arterial pressure release data. At this time, the radial artery side compression head remains locked and continues to apply pressure.
[0183] S06: Real-time collection of blood oxygen saturation values and pulse waveforms in the palm area via the blood oxygen monitoring module to generate real-time physiological monitoring data;
[0184] In this embodiment of the invention, simultaneously with the relief of ulnar artery compression, the blood oxygen monitoring module continuously collects blood oxygen saturation values and pulse wave waveforms in the palm area, capturing physiological signal changes during the blood flow recovery process in real time. The monitoring module transmits the dynamically changing photoelectric signals to the control circuit board, where the signal processing component processes the signals in real time and generates continuous real-time physiological data, i.e., real-time physiological monitoring data. This data is simultaneously displayed on the display component, intuitively presenting the fluctuations in blood oxygen saturation values and the recovery status of the pulse wave waveform, providing real-time data support for determining the experimental results.
[0185] S07: Compare the generated real-time physiological monitoring data with the baseline physiological monitoring data to determine whether the blood oxygen saturation has returned to the baseline level and whether the pulse wave waveform has returned to normal within a preset time, and generate Allen test result judgment data;
[0186] In this embodiment of the invention, the data comparison component within the control circuit board retrieves real-time physiological monitoring data and baseline physiological monitoring data, performing item-by-item comparison and analysis. The focus is on determining whether the real-time blood oxygen saturation value recovers to the baseline level within a preset time, and simultaneously verifying whether the pulse wave waveform recovers from a flat baseline under occlusion to a normal fluctuating waveform. After ulnar artery compression is relieved, if blood oxygen saturation recovers to the baseline level ±2% within 10 seconds, and the pulse wave waveform returns to normal, both indicators meet the standards, indicating good palmar arch collateral circulation function; if either indicator fails to meet the standards, collateral circulation function is considered poor. The comparison results and judgment conclusions are integrated to generate Allen test result judgment data, ensuring the objectivity and accuracy of the judgment criteria.
[0187] S08: Based on the generated test results, determine the data, output a side circulation function evaluation report, and complete the entire Allen test process.
[0188] In this embodiment of the invention, based on the Allen test results, the display component of the control circuit board outputs a collateral circulation function assessment report, clearly indicating the test conclusions, baseline and real-time physiological data comparison results, and judgment criteria. The assessment report can be stored through the device's built-in recording component or transmitted to an external storage device via a data transmission component. Subsequently, pressing the radial artery side release button releases the radial artery side compression head lock, resetting it and completing the entire Allen test procedure. All test data and operation records are integrated and archived, providing complete data support for clinical diagnosis and treatment.
[0189] Therefore, the embodiments should be considered as exemplary and non-limiting in all respects, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of the equivalents of the application are intended to be included within the invention.
[0190] The above description is merely a specific embodiment of the present invention, enabling those skilled in the art to understand or implement the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the present invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features of the invention herein.
Claims
1. A continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform, characterized in that, The device includes a base, and integrated on the base are a wrist fixation unit, an arterial compression unit, a positioning adjustment unit, a compression control unit, and a blood oxygen monitoring module. The wrist fixation unit supports and stabilizes the patient's wrist to maintain the testing position. The arterial compression unit includes two independent compression heads, each with a flexible contact pad at its end, for compressing the radial and ulnar arteries respectively. The positioning adjustment unit includes a transverse slide rail mechanism on the base, with the two compression heads mounted on the slide rail via sliders. The sliders have a locking mechanism, and the slide rails have graduations for adjusting and locking the distance between the two compression heads to align with the surface projection points of the radial and ulnar arteries. The compression control unit includes a synchronous pressure application mechanism, an independent locking and release mechanism, and an anti-accidental contact mechanism to achieve synchronous and stable compression of both arteries and selective release on one side. The blood oxygen monitoring module is integrated into the inner side of the wrist fixation unit to collect real-time blood oxygen saturation values and pulse wave data of the patient's palm area.
2. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 1, characterized in that, The wrist fixation unit is used to support and stabilize the patient's wrist to maintain the examination position, including: The wrist fixation unit first conforms to the palmar and dorsal contours of the patient's wrist through an ergonomic curved surface structure, forming a comprehensive support structure for the patient's wrist and generating support and fit data that is adapted to the patient's wrist. Based on the generated support and fit data, the elastic restraint component of the wrist fixation unit automatically adjusts the tightness of the restraint to keep the patient's wrist in the preset Allen test standard position and generate wrist position fixation data. Using the generated wrist position fixation data, the anti-slip limiting component of the wrist fixation unit limits the radial and ulnar sides of the patient's wrist to prevent the patient's wrist from shifting during the test, and generates wrist displacement anti-deviation data.
3. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 1, characterized in that, The two compression heads of the arterial compression unit respectively compress the radial artery and the ulnar artery, including: The arterial compression unit first retrieves the compression head spacing locking data generated by the positioning adjustment unit, determines the surface projection positions of the radial and ulnar arteries corresponding to the two compression heads respectively, and generates arterial compression target point positioning data. Based on the generated arterial compression target location data, the flexible contact pads of the two compression heads synchronously adhere to the corresponding arterial surface locations, generating contact data between the contact pads and the arterial surface. Using the generated contact data, the pressure head applies a preset pressure value to the corresponding artery, so that the blood flow in the radial and ulnar arteries is synchronously blocked, generating arterial blood flow blocking status data.
4. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 1, characterized in that, The positioning adjustment unit adjusts and locks the distance between the two compression heads to align with the surface projection points of the radial and ulnar arteries, including: The positioning adjustment unit first drives the slider to move on the transverse slide rail mechanism according to the size parameters of the patient's wrist, adjusts the distance between the two compression heads, and generates compression head distance adjustment data; Based on the generated pressure head spacing adjustment data, the scale markings next to the slide rail accurately calibrate the position of the pressure head, generating pressure head position calibration data; Using the generated pressure head position calibration data, the slider locking mechanism locks the position of the pressure head to prevent the spacing from changing during the detection process, generating pressure head spacing lock data.
5. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 1, characterized in that, The synchronous pressure application mechanism of the compression control unit achieves synchronous and stable compression of both arteries, including: The synchronous pressure application mechanism first receives the pressure head spacing locking data generated by the positioning adjustment unit, determines the initial position of the two pressure heads, and generates pressure head initial position confirmation data; Based on the generated initial position confirmation data of the pressure head, the lever-link system of the synchronous pressure application mechanism drives the two pressure heads to press down synchronously and vertically through a single driving action, generating synchronous downward pressure driving data of the pressure head; Using the generated synchronous pressing drive data of the pressure head, the synchronous pressing mechanism controls the stroke and force of the pressing to keep the pressure applied by the two pressure heads consistent, thus generating pressure synchronization control data.
6. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 5, characterized in that, The lever-link system of the synchronous pressure application mechanism drives two pressure heads to press down synchronously and vertically through a single driving action, including: The lever-link system first retrieves the synchronous downward pressure drive data of the pressure head, starts the drive component and transmits the drive force to the lever assembly, and generates drive force transmission data; Based on the generated driving force transmission data, the lever assembly converts the driving force into a vertically downward pressure and transmits it to the linkage structure, generating force direction conversion data; Using the generated force direction conversion data, the linkage structure drives the two compression heads to move downward synchronously, so that the compression heads gradually come into contact with the surface of the artery, generating synchronous downward pressure drive data for the compression heads.
7. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 6, characterized in that, The linkage structure drives the two compression heads to move downwards synchronously, gradually bringing the compression heads into contact with the arterial surface, including: The linkage structure first retrieves the force direction conversion data, controls the two pressure heads to move downwards according to the preset motion trajectory, and generates pressure head motion trajectory control data; Based on the generated motion trajectory control data of the compression head, the flexible contact pad of the compression head first contacts the patient's skin and gradually conforms to the surface of the artery, generating skin contact data of the contact pad; Using the generated skin contact data, the linkage structure continues to drive the compression head down to the preset initial compression position, so that the compression head gradually contacts the arterial surface, generating synchronous compression head down pressure drive data.
8. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 7, characterized in that, The independent locking and releasing mechanism of the compression control unit enables selective release of the unilateral compression head, including: The independent locking and releasing mechanism first receives pressure synchronization control data. When the pressure head is pressed down to the working position, it triggers the pawl assembly to engage with the ratchet rack of the pressure head support rod, generating pressure head locking status data. Based on the generated compression head locking status data, the independent locking and release mechanism detects the trigger signals of the two release buttons, determines the side of the compression head that needs to be released, and generates release side determination data; Using the generated release side determination data, the release button on the corresponding side is triggered to disengage the pawl from the ratchet rack, and the corresponding pressure head automatically pops up under the action of the return spring, generating single-side pressure head release status data; Based on the generated data on the release status of the unilateral compression head, the compression head on the unreleased side remains locked, maintaining compression on the corresponding artery, thus generating data on continuous unilateral arterial compression.
9. The continuous monitoring system for baseline blood oxygen saturation and pulse wave waveform according to claim 8, characterized in that, The independent locking and releasing mechanism detects the trigger signals of the two release buttons to determine which side of the pressure head needs to be released, including: The independent locking and releasing mechanism first retrieves the release side determination data, monitors the voltage signal changes of the two release buttons in real time, and generates button trigger signal monitoring data; Based on the generated button trigger signal monitoring data, compare it with the preset button trigger threshold to determine whether there is a valid trigger signal and generate trigger signal validity determination data; Using the generated trigger signal validity determination data, determine the release button side corresponding to the valid trigger signal and generate release side determination data.
10. A method for continuous monitoring of baseline blood oxygen saturation and pulse wave waveform, characterized in that, The method is implemented based on the baseline oxygen saturation and pulse waveform continuous monitoring system as described in any one of claims 1-9 above, and the baseline oxygen saturation and pulse waveform continuous monitoring method includes the following steps: S01: Place the patient's wrist in the wrist fixation unit, which supports, restrains, and limits the wrist, generating wrist position fixation data. S02: Adjust the distance between the two pressure heads by adjusting the positioning adjustment unit, mark the position with the scale marks and then lock the slider to generate pressure head distance locking data; S03: Activate the synchronous pressure application mechanism of the compression control unit, drive the two compression heads to press down synchronously and apply the preset pressure, so as to synchronously block the blood flow of the radial artery and ulnar artery, and generate arterial blood flow blockage status data; S04: Start the blood oxygen monitoring module to collect the baseline blood oxygen saturation value and pulse wave waveform of the patient's palm area and generate baseline physiological monitoring data; S05: Passively simulates a fist-clenching blood-dripping action for patients without the ability to cooperate voluntarily. After completion, the ulnar artery side release button is triggered to relieve the ulnar artery compression and generate unilateral artery compression release data. S06: Real-time collection of blood oxygen saturation values and pulse waveforms in the palm area via the blood oxygen monitoring module to generate real-time physiological monitoring data; S07: Compare the generated real-time physiological monitoring data with the baseline physiological monitoring data to determine whether the blood oxygen saturation has returned to the baseline level and whether the pulse wave waveform has returned to normal within a preset time, and generate Allen test result judgment data; S08: Based on the generated test results, determine the data, output a side circulation function evaluation report, and complete the entire Allen test process.