A new automatic arterial compression device

Abstract

The application discloses a novel automatic artery compression device, and belongs to the technical field of medical hemostasis equipment. The device comprises a fully-transparent compression main body, a sterile hemostatic gel sheet, an automatic inflation and deflation gas path system, a pressure detection and display system, an intelligent timing control system, a dorsalis pedis artery pulsation and skin temperature double-monitoring closed-loop protection system and a dual-power safety system. The device realizes precise pressure control and intelligent intermittent inflation and deflation by relying on a single-chip microcomputer module, the pressure detection precision can reach ±2mmHg, the lower limb peripheral circulation state can be monitored in real time, a four-dimensional closed-loop protection mechanism is constructed, and sound and light alarm is automatically triggered when an abnormality occurs. Meanwhile, the device has the advantages of wound visual observation, sterile anti-infection and dual-power continuous power supply, effectively solves the problems of inaccurate pressure, lack of intelligent control, lack of remote protection and easy infection of traditional devices, replaces manual pressing, reduces the intensity of medical care, improves postoperative hemostasis safety, and has strong clinical adaptability.

Description

Technical Field

[0001] This invention belongs to the field of medical interventional hemostasis equipment technology, specifically relating to a novel automatic arterial compression device, which is suitable for compression hemostasis and limb monitoring after femoral artery puncture in cardiology, interventional radiology, and vascular surgery. Background Technology

[0002] Femoral artery puncture is a routine clinical interventional procedure in cardiology, interventional radiology, and vascular surgery. Post-procedure, prolonged and constant pressure is required at the puncture site to prevent complications such as bleeding, subcutaneous hematoma, pseudoaneurysm, and arteriovenous fistula. Currently, post-procedure hemostasis primarily relies on manual pressure from the physician or the use of traditional femoral artery compression devices.

[0003] Manual compression has many drawbacks: prolonged manual compression can easily lead to insufficient force, resulting in continuous bleeding from the wound; excessive pressure can weaken or eliminate the dorsalis pedis artery pulse, causing adverse reactions such as vagal reflex in the patient. At the same time, manual compression is labor-intensive, has poor pressure stability, and cannot be performed in a standardized manner. The existing femoral artery compression devices on the market have significant technical defects: First, most devices use opaque materials, making it difficult for medical staff to visually observe the puncture site and detect abnormalities such as bleeding, hematoma, and bruising in a timely manner, resulting in a high incidence of postoperative complications. Second, the pressure detection accuracy is poor, and there is no standardized pressure unit. Most devices cannot quantify and display pressure values. Clinical hemostasis is based on mmHg, and pressure imbalance can easily lead to hemostasis failure or damage to the patient's lower limbs and body. Third, they only support fixed-duration compression and lack intelligent intermittent inflation and deflation functions, making them unsuitable for the hemostasis needs of different patients and different surgeries. Fourth, they lack distal lower limb monitoring structures and dual monitoring functions for dorsalis pedis artery pulsation and skin temperature, resulting in a lack of distal lower limb blood supply protection mechanisms and a high risk of lower limb ischemia and injury. Fifth, there are no dedicated sterile hemostatic dressings, making the puncture wound prone to infection and affecting postoperative healing.

[0004] In summary, existing arterial compression devices have technical shortcomings such as the inability to directly observe the puncture point, inaccurate pressure, lack of intelligent control, lack of distal limb protection, and poor anti-infection capabilities. As a result, their clinical safety and practicality are poor. There is an urgent need for a new type of arterial compression device that is intelligent, high-precision, visual, and has closed-loop protection. Summary of the Invention

[0005] The purpose of this invention is to solve the problems of obstructed field of vision, poor pressure accuracy, lack of intelligent intermittent control, lack of distal limb monitoring and protection, and easy occurrence of wound infection and lower limb injury in the existing hemostasis devices after femoral artery puncture. The invention provides a new type of automatic arterial compression device that realizes visual monitoring, precise pressure control, intelligent timed inflation and deflation, dual-parameter closed-loop protection of the distal lower limb, and aseptic hemostasis protection, thereby reducing the workload of medical staff and improving the safety of postoperative hemostasis and the quality of wound healing.

[0006] To achieve the above objectives, the present invention employs the following technical means:

[0007] A novel automatic arterial compression device includes a compression body, a sterile hemostatic gel sheet, an automatic inflation and deflation air circuit system, a millimeter mercury pressure detection and display system, a timed inflation and deflation intelligent control system, a dual monitoring and closed-loop protection system for dorsalis pedis artery pulsation and skin temperature, and a dual power supply safety system.

[0008] The compression body is a completely transparent product with an inflatable airbag embedded inside. A sterile hemostatic gel sheet can be detachably attached to the part of the compression body that contacts the skin. A thigh support and a calf support are fixedly installed at the lower end of the compression body. The sides of the thigh support and the calf support are provided with reserved grooves for fixing the monitoring probe.

[0009] The automatic inflation and deflation air circuit system includes a miniature air pump and a silicone connecting tube. The miniature air pump is connected to the internal air bladder of the compression body through the silicone connecting tube. The miniature air pump integrates a pressure sensor, and the miniature air pump housing is fixedly integrated with an audible and visual alarm module.

[0010] The millimeter-mercury pressure detection and display system includes an LCD screen mounted on the outside of the miniature air pump;

[0011] The timed inflation and deflation intelligent control system is a single-chip microcomputer control module built into the micro air pump.

[0012] The dual monitoring and closed-loop protection system for dorsalis pedis artery pulsation and skin temperature includes a metal monitoring probe that is snapped into a pre-reserved groove.

[0013] The dual-power safety system includes a rechargeable battery built into the miniature air pump and an external power supply interface. The dual-power safety system supplies power to all electrical components of the device.

[0014] The miniature air pump, audible and visual alarm module, pressure sensor, metal monitoring probe, and LCD screen are all electrically connected to the microcontroller control module. The pressure signal collected by the pressure sensor is processed by the microcontroller control module and then transmitted to the LCD screen for real-time display.

[0015] Preferably, the compression body, the calf support, and the thigh support are all equipped with fixing straps on both sides, which are used to fix the hip joint, thigh, and calf respectively, so as to achieve stable fit between the device and the puncture site of the human body.

[0016] Preferably, the contact surfaces of the calf support and thigh support with the skin are made of breathable and moisture-wicking soft fabric.

[0017] Preferably, the sterile hemostatic gel sheet is a disposable absorbable sterile consumable that is adhered and fixed to the outer contact surface of the airbag, and has the functions of hemostasis, wound cushioning, and infection prevention.

[0018] Preferably, the metal monitoring probe is a highly sensitive flat cylindrical metal induction probe with a total probe connection length of 80cm. It is retractable, stretchable, and detachable, and can be snapped into the reserved groove in the leg support. It is used to collect dorsalis pedis artery pulsation signals and distal lower limb skin temperature simulation signals in real time.

[0019] Preferably, the pressure sensor has a pressure detection accuracy of ±2 mmHg and a pressure parameter adjustment range of 0-300 mmHg.

[0020] Preferably, the dual monitoring system for dorsalis pedis artery pulsation and skin temperature, along with the closed-loop protection system, uses pressure, time, pulsation, and skin temperature to construct a four-dimensional closed-loop linkage protection mechanism. When the monitoring data exceeds the preset safety threshold or the lower limb blood supply is abnormal, the microcontroller control module triggers the audible and visual alarm module and controls the air circuit system to automatically depressurize.

[0021] Preferably, the audible and visual alarm module integrates a buzzer and an LED warning light to provide simultaneous sound and light warnings.

[0022] Preferably, the LCD screen can simultaneously display real-time compression pressure, remaining compression time, inflation / deflation status, dorsalis pedis artery pulsation waveform, and skin temperature value, and supports emergency manual deflation and customizable alarm parameter settings.

[0023] Preferably, the microcontroller control module has a built-in preset standard hemostasis program with a timing adjustment range of 1min-180min. It supports two working modes: single-time timed continuous compression and multi-level cyclic intermittent inflation and deflation. The inflation duration and depressurization interval can be set independently. After the device is started, it automatically counts down. After the countdown ends, the air circuit system is controlled to slowly and uniformly depressurize.

[0024] The present invention has the following beneficial effects:

[0025] 1. This invention adopts a fully transparent compression main structure to achieve 360-degree unobstructed visual monitoring. Medical staff can observe abnormalities such as bleeding, hematoma, and bruising at the puncture site in real time and intervene in a timely manner, which greatly reduces the incidence of postoperative complications.

[0026] 2. Equipped with a high-precision millimeter-mercury pressure detection system, the pressure detection accuracy is ±2mmHg. The pressure parameters are quantifiable and precisely adjustable, strictly conforming to the clinical mmHg hemostasis standard. This avoids the problems of excessive pressure damaging the blood supply to the lower limbs and insufficient pressure failing to stop the hemostasis, thus achieving standardized and precise hemostasis operations.

[0027] 3. It is equipped with an intelligent timed and intermittent automatic inflation and deflation control system, which supports multiple working modes and can adapt to the hemostasis needs of patients of different ages and physical conditions as well as different interventional surgeries. It eliminates the need for repeated manual adjustment, has a high degree of automation, greatly reduces the workload of medical staff, and replaces the traditional manual continuous compression.

[0028] 4. It is the first to have a dual-parameter synchronous monitoring function of dorsalis pedis artery pulsation and skin temperature, and to build a four-dimensional closed-loop linkage protection mechanism of pressure, time, pulsation and skin temperature. When the blood supply to the lower limb is abnormal, it can automatically release pressure and sound and light alarms. Multiple safety protections completely avoid the risk of lower limb ischemia and necrosis. The safety level of the equipment is far higher than that of existing products.

[0029] 5. It is equipped with disposable absorbable sterile hemostatic gel sheets to achieve sterile isolation of the wound, effectively prevent infection of the puncture wound, and at the same time have the functions of wound buffering and auxiliary hemostasis, improving the quality of postoperative wound healing. The consumables are simple and convenient to replace and have strong clinical applicability.

[0030] 6. Adopting a dual-power safe power supply mode to ensure continuous and stable operation of the equipment, it is equipped with a retractable monitoring probe and a breathable and moisture-wicking soft leg rest, making it comfortable to wear, easy to operate, and widely adaptable. It can be widely used in postoperative hemostasis scenarios in cardiology, interventional radiology, and vascular surgery departments of medical institutions at all levels, and has high promotional value. Attached Figure Description

[0031] Figure 1 This is a schematic diagram of the structure of the present invention;

[0032] Figure label:

[0033] Compression body 1, sterile hemostatic gel sheet 2, fixation strap 3, calf support 4, reserved groove 5, metal monitoring probe 6, silicone connecting tube 7, miniature air pump 8, external power supply interface 9, rechargeable battery 10, audible and visual alarm module 11, LCD screen 12, single-chip microcomputer control module 13, thigh support 14. Detailed Implementation

[0034] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0035] like Figure 1 As shown, the present invention provides a novel automatic arterial compression device, including a compression body 1, a sterile hemostatic gel sheet 2, an automatic inflation and deflation air circuit system, a millimeter mercury column pressure detection and display system, a timed inflation and deflation intelligent control system, a dual monitoring and closed-loop protection system for dorsalis pedis artery pulsation and skin temperature, and a dual power supply safety system.

[0036] The compression body 1 is a fully transparent product with an internal inflatable air bladder. A sterile hemostatic gel sheet 2 can be detachably attached to the skin contact area of ​​the compression body 1, providing hemostasis, cushioning, and infection prevention. The lower end of the compression body 1 features an integrated thigh support 14 and calf support 4. Both the thigh support 14 and calf support 4 have pre-drilled grooves 5 on their sides for securing and storing the metal monitoring probe 6. The compression body 1, thigh support 14, and calf support 4 are equipped with fixing straps 3 on both sides to secure the hip joint, thigh, and calf respectively, ensuring a stable fit of the device to the puncture site and preventing displacement that could affect hemostasis. Furthermore, the skin contact surfaces of the thigh support 14 and calf support 4 are made of breathable, moisture-wicking, and soft fabric, improving patient comfort and reducing skin stuffiness and pressure marks.

[0037] The automatic inflation / deflation air circuit system includes a miniature air pump 8 and a silicone connecting tube 7. The miniature air pump 8 is connected to the internal airbag of the compression body 1 through the silicone connecting tube 7, realizing automatic inflation and deflation of the airbag. The miniature air pump 8 integrates a high-precision pressure sensor, which can collect the airbag compression pressure in real time. The housing of the miniature air pump 8 integrates an audible and visual alarm module 11 for abnormal condition warning.

[0038] The millimeter-Hg pressure detection and display system consists of an LCD screen 12 installed on the outside of the miniature air pump 8. It can accurately display standardized mmHg pressure values, with a pressure detection accuracy of ±2 mmHg and a pressure adjustment range covering 0-300 mmHg, fully adapting to clinical hemostasis pressure standards.

[0039] The timed inflation and deflation intelligent control system uses a single-chip microcomputer control module 13 built into the micro air pump 8 as the core control unit. The timed adjustment range is 1min-180min. It supports two working modes: single timed continuous compression and multi-level cyclic intermittent inflation and deflation. The inflation duration and depressurization interval can be set independently. After the device starts, it automatically counts down. After the countdown ends, the air circuit system is controlled to slowly and uniformly depressurize, adapting to the personalized hemostasis needs of different patients and different surgeries.

[0040] The dual monitoring and closed-loop protection system for dorsalis pedis artery pulsation and skin temperature employs a highly sensitive flat cylindrical metal monitoring probe 6. The probe's connecting cable is 80cm long, stretchable, retractable, and detachable, and snaps into a pre-reserved groove 5. It can collect real-time dorsalis pedis artery pulsation signals and simulated skin temperature signals from the distal lower limb. This system links pressure, time, pulsation, and skin temperature to construct a four-dimensional closed-loop linkage protection mechanism. When the monitored data exceeds the preset safety threshold or the lower limb blood supply is abnormal, the microcontroller control module 13 immediately triggers the audible and visual alarm module 11, and simultaneously controls the airway system to automatically depressurize, eliminating the risk of lower limb ischemia and necrosis.

[0041] The dual power supply safety system includes a rechargeable battery 10 built into the miniature air pump 8 and an external power supply interface 9. The dual power supply mode ensures the continuous and stable operation of the equipment, avoids equipment shutdown and hemostasis interruption caused by power failure of a single power supply mode, and improves the safety of clinical use.

[0042] Furthermore, the LCD screen 12 can simultaneously display real-time compression pressure, remaining compression time, inflation / deflation status, dorsalis pedis artery pulsation waveform, and skin temperature value. It also features emergency manual deflation and customizable alarm parameter settings, making it easy to operate and suitable for clinical emergency scenarios.

[0043] Furthermore, the sterile hemostatic gel sheet 2 is a disposable absorbable sterile consumable that is easy to replace. It can always maintain the sterility of the puncture wound, effectively prevent postoperative infection, and at the same time, it can buffer and decompress the wound, improving the hemostatic effect and patient comfort.

[0044] Working principle

[0045] This novel automatic arterial compression device relies on a mechanical fixation structure, a controllable pneumatic compression principle, high-precision pressure detection, intelligent timed inflation and deflation control, dual-parameter monitoring of the lower limb distal end, and a four-dimensional closed-loop safety protection logic to work collaboratively. It replaces traditional manual compression and simple compression devices, achieving precise, visual, intelligent, and highly safe automatic hemostasis and limb monitoring after femoral artery puncture. The overall working principle can be divided into six core modules: structural fixation, pneumatic pressure hemostasis, intelligent timing control, real-time monitoring and sampling, closed-loop safety protection, and dual-power regulated power supply, as detailed below:

[0046] I. Overall structural fixation and aseptic protection principle

[0047] The device uses multiple sets of fixing straps 3, consisting of a compression body 1, thigh support 14, and calf support 4, to secure the patient's hip joint, thigh, and calf respectively. This ensures that the fully transparent compression body 1 precisely and stably conforms to the femoral artery puncture wound, effectively preventing hemostasis failure caused by device displacement or pressure deviation. A disposable absorbable sterile hemostatic gel sheet 2 is adhered to the skin-contact interface of the compression body 1. This maintains a sterile wound environment during pressure application, preventing infection of the puncture wound. Simultaneously, the flexible cushioning properties of the gel material evenly distribute the airbag pressure, preventing excessive local pressure that could damage the skin and blood vessels, aiding in wound clotting, and improving hemostasis. Furthermore, the thigh support 14 and calf support 4 are made of breathable, moisture-wicking, soft fabric, ensuring comfort during prolonged wear and preventing stuffiness and pressure sores.

[0048] II. Working Principle of Automatic Pneumatic Pressure Hemostasis

[0049] The device uses pneumatic flexible compression as its core hemostatic principle, with a microcontroller control module 13 as the control core, driving the micro air pump 8. The micro air pump 8 delivers gas at a uniform speed to the inflatable bladder inside the compression body 1 through the silicone connecting tube 7, causing the bladder to expand and generate continuous and uniform pressure on the femoral artery puncture site. A built-in high-precision pressure sensor collects the air pressure value inside the bladder in real time, with a detection accuracy of ±2mmHg, and transmits the analog signal to the microcontroller control module 13 in real time. After data processing, the standardized mmHg pressure value is synchronously displayed on the LCD screen 12.

[0050] Medical staff can precisely set the hemostatic pressure within the range of 0-300 mmHg according to the patient's body size, surgical type, and coagulation status. The equipment automatically stabilizes the pressure and maintains a constant pressure throughout the process, completely solving the defects of unstable pressure during manual compression and the inability to quantify pressure in traditional equipment, thus achieving standardized and precise pneumatic hemostasis.

[0051] III. Principle of Intelligent Timed and Intermittent Gas Inflation and Discharge Control

[0052] The microcontroller control module 13 has a built-in dedicated hemostasis control program, supporting a wide timer range of 1min-180min. It has two working modes: single continuous compression and multi-level cyclic intermittent inflation / deflation. Medical staff can independently set the inflation duration and depressurization interval. The device automatically enters a countdown working state after startup.

[0053] In intermittent operation mode, the device automatically completes the cycle of inflation and pressure stabilization, short-term depressurization, and re-inflation according to a preset program. This effectively improves local microcirculation in the lower limbs and avoids limb ischemia, numbness, and pain caused by continuous high pressure compression, making it suitable for the hemostasis needs of elderly patients, patients with poor vascular conditions, and other special populations. When the preset total compression time countdown ends, the microcontroller control module 13 controls the micro air pump 8 to automatically and slowly depressurize at a uniform speed, avoiding secondary bleeding from the wound caused by rapid depressurization and completing the postoperative hemostasis process.

[0054] IV. Principle of Real-time Dual-Parameter Monitoring of Lower Extremities

[0055] The device relies on a retractable, highly sensitive metal monitoring probe 6 to achieve distal lower limb monitoring. The metal monitoring probe 6 is positioned and fixed by a pre-reserved groove 5 on the leg rest. The 80cm stretchable connecting cable can be freely adapted to the length of the patient's lower limb. The probe extends to the dorsum of the foot area and collects two core parameters in real time: one is the dorsalis pedis artery pulsation signal, which is used to determine the patency of lower limb arterial blood supply; the other is the distal lower limb skin temperature simulation signal, which is used to reflect the peripheral blood circulation status of the limb.

[0056] The collected pulsation waveform and skin temperature data are transmitted to the microcontroller control module 13 in real time and simultaneously displayed on the LCD screen 12. This allows medical staff to monitor the peripheral circulation status of the patient's lower limbs in real time without repeated physical examinations, solving the technical drawbacks of traditional compression devices that lack remote monitoring and involve blind compression.

[0057] V. Four-dimensional closed-loop linkage safety protection principle

[0058] The core safety logic of this device is a four-dimensional closed-loop linkage protection mechanism based on pressure, time, dorsalis pedis artery pulsation, and skin temperature. The single-chip microcomputer control module 13 compares the four parameters with the preset safety threshold in real time to achieve intelligent protection at all times.

[0059] During operation, if any abnormal blood supply situation occurs, such as excessively high / low compression pressure, weakened / absent dorsalis pedis artery pulsation, or abnormally low lower limb skin temperature, the microcontroller control module 13 will immediately trigger the audible and visual alarm module 11. This will provide a dual warning through a buzzer sound and LED light, while simultaneously controlling the air circuit system to automatically depressurize, relieving the high pressure on the femoral artery and quickly restoring blood supply to the lower limbs. This will fundamentally prevent serious complications such as limb ischemia, nerve damage, vagal reflex, and vascular necrosis, achieving intelligent closed-loop safety management with "abnormality is protection".

[0060] VI. Working principle of dual power supply for safe operation

[0061] The device employs a dual power supply mode, combining a built-in rechargeable battery (10) with an external power interface (9) for connecting to mains power. These two power supply methods can be seamlessly switched and serve as backups for each other. The built-in rechargeable battery (10) allows the device to be used independently without a power cord, suitable for ward transport and patient positioning scenarios. The external power interface (9) provides uninterrupted power for extended periods, meeting the needs of prolonged hemostasis surgeries. The dual power system provides stable power to all electrical components, including the miniature air pump (8), microcontroller control module (13), monitoring probe, audible and visual alarm module (11), and LCD screen (12), eliminating the risk of equipment shutdown, pressure interruption, or monitoring failure due to a single power supply failure, ensuring stable operation throughout the entire process.

[0062] VII. Working Principle of Visual Monitoring

[0063] The compression body 1 is made of a completely transparent material. During the entire process of applying pressure to stop bleeding, medical staff can directly observe the condition of the puncture wound from 360° without any obstruction. They can check for bleeding, subcutaneous hematoma, skin bruising, and other abnormalities in real time. This allows for the immediate detection and intervention of potential postoperative complications, making up for the shortcomings of traditional opaque compression devices that cannot observe the wound and have delayed detection of complications, thus greatly improving the safety of postoperative hemostasis.

[0064] Example 1: Continuous Compression Hemostasis after Conventional Femoral Artery Intervention

[0065] This embodiment is applicable to ordinary adult patients who have undergone percutaneous femoral artery puncture coronary intervention surgery, have good vascular conditions, normal coagulation function, and no underlying vascular disease, and use the device's single-time timed continuous compression hemostasis mode.

[0066] During device assembly, a brand-new disposable absorbable sterile hemostatic gel sheet 2 is first attached to the contact surface of the airbag of the compression body 1 to ensure sterile protection of the puncture wound. The patient's hip joint, thigh, and calf are then secured using the fixing straps 3 on both sides of the compression body 1, thigh support 14, and calf support 4, ensuring the fully transparent compression body 1 precisely conforms to the femoral artery puncture point, and the entire device is firmly attached without displacement. The high-sensitivity metal monitoring probe 6 is then clipped into the pre-reserved grooves 5 on the sides of the calf support 4 and thigh support 14. The 80cm connecting cable is stretched to fix the metal monitoring probe 6 at the location of the dorsalis pedis artery pulsation, completing the monitoring and positioning.

[0067] The operating parameters are set via the LCD screen 12 on the outside of the miniature air pump 8: Based on standard adult hemostasis criteria, the compression pressure is set to 120 mmHg, with the pressure error precisely controlled within ±2 mmHg by the device's pressure sensor. The duration of a single continuous compression is set to 60 minutes. Real-time monitoring of dorsalis pedis artery pulsation and skin temperature is enabled, and a preset safety threshold is established. After parameter settings are completed, the device is started. The microcontroller control module 13 controls the miniature air pump 8 to inflate the air bladder of the compression body 1 at a uniform speed through the silicone connecting tube 7, quickly reaching the preset pressure and automatically stabilizing it, continuously applying constant pressure to the puncture point.

[0068] During hemostasis, the dual-power safety system adopts an external power supply interface 9 with AC power supply mode to ensure continuous and stable operation of the equipment; medical staff can observe the puncture point in real time through the fully transparent compression body 1 to visually check for bleeding and hematoma; the metal monitoring probe 6 collects the waveform of the dorsalis pedis artery pulsation and the skin temperature of the lower limb in real time and displays them simultaneously on the LCD screen 12; the single-chip microcomputer control module 13 compares the four parameters of pressure, time, pulsation and skin temperature in real time to maintain four-dimensional closed-loop protection.

[0069] Throughout the procedure, the patient's lower limb blood supply remained stable, skin temperature was normal, and no abnormal alarms were triggered. After 60 minutes, the device slowly and uniformly depressurized under the control of the single-chip microcomputer module 13. After depressurization, the device was removed. There was no bleeding or subcutaneous hematoma at the puncture site, the dorsalis pedis artery pulse was normal, and the skin temperature was normal. The hemostasis effect was good, and no postoperative complications occurred.

[0070] Example 2: Intermittent inflation and deflation for hemostasis in elderly patients with fragile blood vessels

[0071] This embodiment is suitable for elderly patients over 75 years old. After femoral artery puncture, the patient has poor vascular elasticity, weak peripheral circulation, and has a history of insufficient blood supply to the lower limbs. Therefore, it is not suitable for long-term continuous high pressure compression. The device adopts a multi-level cyclic intermittent inflation and deflation working mode.

[0072] The pre - installation and aseptic protection process of the device is the same as that in Example 1. Replace the brand - new aseptic hemostatic gel sheet 2, and stably fix the compression main body 1, thigh support 14, and calf support 4 through the fixing strap 3 to complete the clamping and positioning installation of the metal monitoring probe 6. Considering the fragile blood vessels of elderly patients, the compression pressure parameter is adjusted personalizedly. Set the working pressure to 90 mmHg through the liquid crystal display screen 12, control the pressure accuracy within ±2 mmHg, set the total compression duration to 120 min, turn on the intermittent inflation and deflation mode, customize the inflation maintenance duration to 10 min and the pressure relief interval duration to 2 min, reserve sufficient time for the recovery of peripheral microcirculation, and at the same time turn on the whole - process monitoring and sound - light alarm functions.

[0073] After the device is started, the single - chip microcomputer control module 13 automatically operates in a cyclic manner according to the preset program: inflate and stabilize the pressure for 10 min, automatically relieve the pressure briefly for 2 min, and then inflate and pressurize again, repeating in a cycle. During the working process, the built - in power supply mode of the rechargeable battery 10 is adopted, which is convenient for the patient to slightly adjust the body position and avoids the influence of the power cord pulling on the device fitting degree. The metal monitoring probe 6 continuously monitors the skin temperature and arterial pulsation state of the lower limbs, and the four - dimensional closed - loop system is linked for protection throughout the process, effectively avoiding problems such as lower limb ischemia, numbness, and vasospasm caused by continuous high pressure.

[0074] During the intermittent pressure relief stage, the peripheral microcirculation of the patient's lower limbs recovers rapidly, the skin temperature is stable, the pulsation is regular, and there is no limb coldness, numbness or discomfort; there are no abnormal pressure and circulation conditions throughout the process, and the sound - light alarm module 11 does not trigger an early warning. After the total duration of 120 min ends, the device automatically relieves all the pressure completely. After removing the device, the puncture wound heals well, without blood leakage or bruising. The patient's lower limbs can move normally, and no adverse reactions such as vasovagal reflex and ischemic injury occur, meeting the hemostasis requirements of elderly and vulnerable patients.

[0075] Example 3: Closed - loop protection hemostasis after complex long - time surgery

[0076] This example is applicable to patients undergoing complex vascular intervention surgery with an operation duration exceeding 3 h. After the operation, the puncture site wound is relatively large and the bleeding risk is high. Long - time precise compression + whole - process high - risk monitoring and protection are required, and the four - dimensional closed - loop linkage protection and abnormal automatic intervention functions of the device are mainly verified.

[0077] After the device is assembled and fixed conventionally, replace the thickened aseptic hemostatic gel sheet 2 to strengthen the wound protection. Set the high - pressure hemostasis parameters through the liquid crystal display screen 12: the compression pressure is 150 mmHg, accurately controlled within an error range of ±2 mmHg, the total compression duration is 180 min, and the continuous compression mode is adopted. At the same time, strictly lock the warning thresholds of pulsation, skin temperature, and pressure, and turn on the highest - level safety protection mechanism. The device adopts a dual - power backup mode of an external power supply interface 9 + rechargeable battery 10 to eliminate the risk of power failure during long - time operation.

[0078] For the first 100 minutes of normal operation, the pressure was stable, the dorsalis pedis artery pulsation was steady, and the lower limb skin temperature was normal. No bleeding or hematoma was observed at the puncture site through the transparent compression body 1, and the equipment operated smoothly. At 102 minutes, due to a slight change in the patient's position, local pressure on the lower limb caused a decrease in peripheral skin temperature and a weakening of the dorsalis pedis artery pulsation amplitude. The monitored data were below the preset safety threshold.

[0079] At this moment, the microcontroller control module 13 immediately identifies the abnormality of the four parameters and instantly triggers the audible and visual alarm module 11. The LED warning light flashes and the buzzer sounds continuously. Simultaneously, it actively controls the airway system to automatically and slowly depressurize, relieving the high-pressure compression and quickly restoring blood supply to the patient's lower limbs. Medical staff promptly check the patient's position based on the alarm prompts. After fine-tuning the lower limb placement, the peripheral circulation parameters return to normal. After confirming that the parameters are within acceptable limits via the LCD screen 12, the medical staff restart the equipment to continue the remaining time of compression hemostasis.

[0080] Throughout the procedure, the equipment employed intelligent closed-loop protection to promptly mitigate the risk of lower limb ischemia caused by changes in body position, preventing any limb injury to the patient. After the entire 180-minute compression process was completed, the equipment automatically depressurized, ensuring thorough hemostasis at the puncture site without postoperative complications. This fully validated the core advantages of the equipment—high-precision monitoring, intelligent early warning, and proactive protection—and demonstrated its ability to meet the safety requirements for hemostasis in complex, high-risk surgical procedures.

[0081] The examples provided in this invention are not intended to limit the implementation. Those skilled in the art will recognize that various variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations, and any obvious variations or modifications derived therefrom are still within the scope of this invention.

Claims

1. A novel automatic arterial compression device, characterized in that: Includes a compression body (1), a sterile hemostatic gel sheet (2), an automatic inflation and deflation airway system, a millimeter mercury column pressure detection and display system, a timed inflation and deflation intelligent control system, a dual monitoring and closed-loop protection system for dorsalis pedis artery pulsation and skin temperature, and a dual power supply safety system; The compression body (1) is a fully transparent product with an inflatable airbag embedded inside. A sterile hemostatic gel sheet (2) can be detachably pasted at the point where the compression body (1) contacts the skin. A thigh support (14) and a calf support (4) are fixedly installed at the lower end of the compression body (1). The sides of the thigh support (14) and the calf support (4) are provided with reserved grooves (5) for fixing the monitoring probe. The automatic inflation and deflation air circuit system includes a micro air pump (8) and a silicone connecting tube (7). The micro air pump (8) is connected to the internal air bladder of the compression body (1) through the silicone connecting tube (7). The micro air pump (8) integrates a pressure sensor inside and has an audible and visual alarm module (11) fixedly integrated in the housing of the micro air pump (8). The millimeter-mercury pressure detection and display system includes an LCD screen (12) installed on the outside of the micro air pump (8). The timed charging and discharging intelligent control system is a single-chip microcomputer control module (13) built into the micro air pump (8). The dual monitoring and closed-loop protection system for dorsalis pedis artery pulsation and skin temperature includes a metal monitoring probe (6) that is snapped into a reserved groove (5). The dual power safety system includes a rechargeable battery (10) built into the micro air pump (8) and an external power supply interface (9). The dual power safety system supplies power to all electrical structures of the device. The micro air pump (8), the sound and light alarm module (11), the pressure sensor, the metal monitoring probe (6), and the LCD screen (12) are all electrically connected to the microcontroller control module (13). The pressure signal collected by the pressure sensor is processed by the microcontroller control module (13) and then transmitted to the LCD screen (12) for real-time display.

2. The novel automatic arterial compression device according to claim 1, characterized in that: The compression body (1), the lower leg support (4), and the thigh support (14) are all equipped with fixing straps (3) on both sides, which are used to fix the hip joint, thigh and lower leg respectively, so as to achieve stable fit between the device and the human puncture site.

3. The novel automatic arterial compression device according to claim 2, characterized in that: The calf support (4) and thigh support (14) are made of breathable and moisture-wicking soft fabric in contact with the skin.

4. The novel automatic arterial compression device according to claim 1, characterized in that: The sterile hemostatic gel sheet (2) is a disposable absorbable sterile consumable that is attached to the outer contact surface of the airbag and has the functions of hemostasis, wound buffering and infection prevention.

5. The novel automatic arterial compression device according to claim 1, characterized in that: The metal monitoring probe (6) is a highly sensitive flat cylindrical metal induction probe with a total probe connection length of 80cm. It can be stored, stretched, and detachably snapped into the reserved groove (5) in the leg support. It is used to collect the dorsalis pedis artery pulsation signal and the simulated skin temperature signal of the lower extremity in real time.

6. The novel automatic arterial compression device according to claim 1, characterized in that: The pressure sensor has a pressure detection accuracy of ±2 mmHg and a pressure parameter adjustment range of 0-300 mmHg.

7. The novel automatic arterial compression device according to claim 1, characterized in that: The dual monitoring of dorsalis pedis artery pulsation and skin temperature, along with the closed-loop protection system, establishes a four-dimensional closed-loop linkage protection mechanism based on four parameters: pressure, time, pulsation, and skin temperature. When the monitoring data exceeds the preset safety threshold and the blood supply to the lower limbs is abnormal, the single-chip microcomputer control module (13) triggers the sound and light alarm module (11) to work and controls the air circuit system to automatically depressurize.

8. The novel automatic arterial compression device according to claim 1, characterized in that: The sound and light alarm module (11) integrates a buzzer and an LED warning light to provide simultaneous sound and light warning prompts.

9. A novel automatic arterial compression device according to claim 1, characterized in that: The LCD screen (12) can simultaneously display real-time compression pressure, remaining compression time, inflation / deflation status, dorsalis pedis artery pulsation waveform, and skin temperature value, and supports emergency manual deflation and custom settings of alarm parameters.

10. A novel automatic arterial compression device according to claim 1, characterized in that: The microcontroller control module (13) has a built-in preset standard hemostasis program with a timing adjustment range of 1min-180min. It supports two working modes: single-time timed continuous compression and multi-level cyclic intermittent inflation and deflation. The inflation duration and depressurization interval can be set independently. After the device starts, it automatically counts down. After the countdown ends, it controls the air circuit system to slowly and uniformly depressurize.

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