Novel medical balloon pressure pump device

Abstract

The invention provides a novel medical balloon pressure pump device which is characterized in that the novel medical balloon pressure pump device comprises a pump body used for pumping a medium into a balloon and pressurizing or depressurizing the balloon to enable the balloon to expand or retract; the monitoring part comprises a pressure monitoring assembly arranged in the pump main body and used for monitoring the volume of the balloon and a flow monitoring sensor used for monitoring the volume of an input medium in the balloon; the control part is electrically connected with the pressure monitoring assembly and the flow monitoring sensor and used for processing and displaying data monitored by the pressure monitoring assembly and data monitored by the flow monitoring sensor.

Description

Technical Field

[0001] This invention relates to the technical field of medical devices, specifically to a novel medical balloon pressure pump device. Background Technology

[0002] Vascular occlusive diseases are a group of diseases characterized by narrowing and occlusion of blood vessels. Obstructed blood flow leads to insufficient perfusion of ischemic tissues and organs, resulting in organ damage and a series of pathological changes. Based on the location and cause of the occlusion, thromboocclusive diseases can be classified into various types, commonly including arterial occlusion, venous thrombosis, and microvascular complications. Common types include coronary artery occlusion, peripheral artery occlusion, cerebral vascular occlusion, and deep vein thrombosis. The main risk factors for the development of these diseases are usually closely related to hypertension, diabetes, atherosclerosis, thrombosis, smoking, and alcohol consumption. The goal of treating vascular occlusive diseases is to restore blood perfusion, alleviate symptoms, and prevent complications; currently, angioplasty is a commonly used treatment for vascular occlusive diseases.

[0003] Angioplasty is a minimally invasive interventional treatment technique that primarily uses minimally invasive surgery to restore blood flow. A dilating balloon is inserted through a catheter into the narrowed or blocked area of ​​the blood vessel. A pressure pump inflates the balloon, causing it to expand and compress plaque or thrombus on the vessel wall, helping to dilate the vessel, improve blood flow, and restore vascular patency.

[0004] Balloon inflation is a core step in angioplasty. To ensure effective balloon dilation and avoid vascular damage, the inflation pressure and time need precise control. Excessive pressure may cause vascular rupture, while insufficient pressure may fail to dilate the vessel effectively, leading to poor treatment outcomes. Therefore, specialized balloon dilation pressure pumps are often used in angioplasty to precisely control the inflation pressure and time. These devices not only provide stable high pressure but also adjust the inflation time and pressure according to different types of stenosis or occlusion, ensuring a safe and efficient balloon dilation process, making them a core component of the balloon dilation system. The device pumps in liquid or gas manually or electrically to achieve balloon dilation and pressure application. The working principle of the balloon dilation pressure pump is based on the Paul Kalman law, which states that in a closed space, gas volume is inversely proportional to pressure; when the gas volume decreases, the gas pressure increases. The balloon dilation pressure pump reduces the gas volume inside the balloon by drawing air out of the pump body, thus shrinking the balloon. When air is injected into the balloon, the gas volume inside the balloon increases, and the balloon dilates. During this process, the pressure inside the balloon increases as the balloon expands, thereby expanding and fixing the expanded lumen to achieve the purpose of dilating the blood vessel or placing a stent in the blood vessel.

[0005] While balloon dilation pressure pumps play a crucial role in ensuring efficiency and safety during balloon dilation, current research and technological advancements have focused primarily on updating and improving the balloon itself. In contrast, there has been less innovation in balloon dilation pressure pumps, with most relying on existing, mature technologies to support the balloon dilation process. Currently, balloon dilation pressure pumps have some limitations in practical use:

[0006] While a pressure gauge can display the pressure inside the balloon, it cannot detect the volume of the medium (mainly liquid) inside the balloon in real time. Furthermore, because the balloon's size cannot be observed in real time, it's difficult to accurately determine the balloon's pressure release status. Although imaging equipment can be used to observe the balloon's image status, the imaging is two-dimensional (2D), making it difficult to accurately assess the balloon's actual condition. This can easily lead to vascular damage and complications due to improper pressure or liquid volume control.

[0007] Based on the problems existing in the clinical application of current balloon dilation devices and our years of experience, we recognize that there is still room for improvement in certain aspects. Therefore, we propose an innovation aimed at addressing the shortcomings of existing technologies and further optimizing the efficacy and safety of balloon dilation. Summary of the Invention

[0008] This invention was made to solve the above-mentioned problems, and its purpose is to provide a novel medical balloon pressure pump device.

[0009] A novel medical balloon pressure pump device is characterized by comprising: a pump body for pumping media into a balloon and pressurizing or depressurizing the balloon to inflate or deflate it, including a syringe; a monitoring unit including a pressure monitoring component disposed inside the pump body for monitoring the balloon volume and a flow monitoring sensor for monitoring the volume of the input media within the balloon; a control unit electrically connected to the pressure monitoring component and the flow monitoring sensor for processing and displaying the data monitored by the pressure monitoring component and the flow monitoring sensor; a first catheter, one end of which is connected to the outlet end of the syringe; and a second catheter, one end of which is connected to the other end of the first catheter and the other end of which is connected to the balloon.

[0010] The novel medical balloon pressure pump device provided by the present invention may also have the following features: wherein the pump body further includes: an operating handle for medical personnel to hold and move to pump the medium into the balloon, and to pressurize or depressurize the balloon to expand or retract the balloon; a syringe is connected to the operating handle; and a switch is provided on the syringe.

[0011] The novel medical balloon pressure pump device provided by this invention may also have the following features: wherein the pressure monitoring component is disposed inside the syringe, and the pressure monitoring component includes: a pressure sensor, which is a silicon piezoresistive pressure sensor; and a temperature sensor, which is a forward-biased silicon microdiode disposed in the non-diaphragm region of the silicon piezoresistive pressure sensor chip, for monitoring changes in ambient temperature T and performing temperature compensation.

[0012] The novel medical balloon pressure pump device provided by the present invention may also have the following feature: the syringe is provided with a microchannel, and pressure sensors are provided at both ends of the microchannel to monitor the pressure difference ΔP between the two ends of the microchannel.

[0013] The novel medical balloon pressure pump device provided by this invention may also have the following feature: wherein the volumetric flow rate Q is linearly related to ΔP.

[0014] Q = (π D 4 ) / (128 L) · ΔP / μ(T) (1)

[0015] Wherein, the geometric constant K_geo = πD 4 / (128 L); K_geo is determined by the fabrication dimensions of the microchannel; D is the diameter of the microchannel; L is the length of the microchannel; μ(T) is the dynamic viscosity of the liquid, which varies exponentially with temperature:

[0016] μ(T) = μ_ref · exp[γ (T_ref - T)] (2)

[0017] After correcting for temperature drift, ΔP is substituted into equations (1) and (2) to complete zero-point sensitivity compensation and viscosity correction within a 1 ms period, and output the temperature-compensated flow rate value in real time.

[0018] The novel medical balloon pressure pump device provided by this invention may also have the following features: the inner diameter of the microchannel is 50–200 µm, the length is 3–10 mm, the wall thickness is < 0.1 mm, and its inner wall is coated with a hydrophilic coating.

[0019] The novel medical balloon pressure pump device provided by this invention may also have the following features: the chip is encapsulated with medical epoxy or silicone on the side near the microchannel, and the other side is encapsulated with Parylene-C.

[0020] The novel medical balloon pressure pump device provided by this invention may also have the following features: the flow monitoring sensor is a MEMS hot film chip, which integrates a silicon diode and a hot film. The MEMS hot film chip is encapsulated with medical epoxy resin and embedded in the syringe wall.

[0021] The novel medical balloon pressure pump device provided by this invention may also have the following feature: wherein the flow rate calculation formula is:

[0022]

[0023] Where Q: volumetric flow rate mL / min, k: flow coefficient, ΔT: temperature difference between the thermal film and the environment °C, P heater Heating power (mW, kWh) loss Heat loss coefficient (mW / ℃)

[0024] The novel medical balloon pressure pump device provided by the present invention may also have the following features: the control unit includes a display screen and a microcontroller (MCU), both of which are electrically connected to the pressure monitoring component and the flow monitoring sensor, and the microcontroller is set on the display screen.

[0025] The role and effect of invention

[0026] The novel medical balloon pressure pump device according to the present invention has the following beneficial effects:

[0027] The pressure pump device of this invention comprises a pump body, a monitoring unit, and a control unit. The monitoring unit includes a pressure monitoring component and a flow monitoring sensor. By incorporating the pressure monitoring component, the volume of the balloon can be monitored in real time; by incorporating the flow monitoring sensor, the flow rate of the input medium within the balloon can be monitored in real time. The control unit is electrically connected to the pressure monitoring component and the flow monitoring sensor, and is used to process and display the data monitored by the pressure monitoring component and the flow monitoring sensor. The data transmission frequency is 10 Hz, i.e., updated every 100 milliseconds, ensuring the real-time nature and accuracy of the data. This invention, through more precise monitoring and control, enables the pressure pump device to operate more accurately in interventional procedures such as angioplasty, reducing vascular damage and complications caused by improper pressure or volume control, and improving the success rate and safety of the surgery. This invention upgrades the pressure display device in the prior art to a dual flow and pressure display, making the data display more intuitive and facilitating real-time monitoring and analysis by physicians. Attached Figure Description

[0028] Figure 1 This is a schematic diagram of the overall structure of the novel medical balloon pressure pump device in an embodiment of the present invention, wherein, Figure 1 A is a schematic diagram of the pump body; Figure 1 B is a schematic diagram of the structure of the first catheter and the second catheter; Figure 1 C is a schematic diagram of the balloon structure; Figure 1 D is a schematic diagram of the display screen and microcontroller; Figure 1 E is a schematic diagram of the structure of a novel medical balloon pressure pump device.

[0029] Figure 2 This is a schematic diagram of the monitoring unit in an embodiment of the present invention.

[0030] Figure 3 This is a schematic diagram illustrating the working principle of the silicon piezoresistive pressure sensor in this embodiment of the invention.

[0031] Figure 4 This is a schematic diagram illustrating the principle of the temperature compensation method in an embodiment of the present invention.

[0032] Figure 5 This is a schematic diagram of the structure of the first pressure sensor and the first temperature sensor in an embodiment of the present invention.

[0033] Figure 6 This is a schematic diagram of the internal structure of the microchannel in an embodiment of the present invention.

[0034] Figure 7 This is a graph showing the regression analysis results in an embodiment of the present invention.

[0035] Explanation of symbols for main components:

[0036] In the diagram: 100. Novel medical balloon pressure pump device; 1. Operating handle; 2. Connector; 3. Syringe; 4. Switch; 5. Indicator; 6. Scale marking; 8. First catheter; 9. Second catheter; 10. First pressure sensor; 11. First temperature sensor; 12. Second pressure sensor; 13. Second temperature sensor; 14. Microchannel; 16. Balloon; 17. Flow monitoring sensor; 19. Microcontroller; 20. Alarm module; 21. Microcontroller integrated information module; 22. NFC communication module; 23. Display screen. Detailed Implementation

[0037] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication between two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0038] To make the technical means, creative features, objectives and effects of this invention easy to understand, the following embodiments, in conjunction with the accompanying drawings, provide a detailed description of the novel medical balloon pressure pump device of this invention.

[0039] Figure 1 This is a schematic diagram of the overall structure of the novel medical balloon pressure pump device in an embodiment of the present invention, wherein, Figure 1 A is a schematic diagram of the pump body; Figure 1 B is a schematic diagram of the structure of the first catheter and the second catheter; Figure 1 C is a schematic diagram of the balloon structure; Figure 1 D is a schematic diagram of the display screen and microcontroller; Figure 1 E is a schematic diagram of the structure of a novel medical balloon pressure pump device.

[0040] like Figure 1 As shown, the novel medical balloon pressure pump device (hereinafter referred to as the pressure pump device) 100 in this embodiment includes a pump body, a monitoring unit, a control unit, a first catheter 8, and a second catheter 9.

[0041] The monitoring unit includes a pressure monitoring component for monitoring the volume of the balloon 16, which is located inside the pump body, and a flow monitoring sensor 17 for monitoring the volume of the input medium inside the balloon 16.

[0042] The control unit includes a display screen 23 and a microcontroller MCU 19, both electrically connected to the pressure monitoring components and the flow monitoring sensor 17. The display screen 23 uses a high-resolution LCD screen, clearly displaying pressure and flow data. The microcontroller 19 is embedded on the side of the display screen 23 furthest from the screen. The microcontroller 19 has a microcontroller integrated information module 21 and an NFC communication module 22, supporting NFC functionality with a data transmission frequency of 10 Hz, updating every 100 milliseconds. Pressure is measured in atm with an accuracy of 0.01 atm; flow is measured in mL / min with an accuracy of ±3%FS. Furthermore, the display screen 23 can also display alarm information, indicating abnormal conditions such as excessive pressure or abnormal flow, and can display pressure and flow curves for the past 10 minutes, facilitating real-time monitoring and data analysis by the physician. The microcontroller 19 also includes an alarm module 20, including a speaker and a vibration motor. When the pressure or flow exceeds a preset threshold, it will alert the physician through sound and vibration alarms, ensuring the safety of the surgical procedure. The sound alarm emits an alarm sound through a speaker, while the vibration alarm provides tactile feedback through a vibration motor. This dual alarm mechanism ensures that doctors receive timely alerts in any situation.

[0043] The pump body is used to pump the medium into the balloon 16 and pressurize or depressurize the balloon 16 to expand or retract the balloon 16. It includes: an operating handle 1, a connector 2, a syringe 3, and a switch 4.

[0044] The operating handle 1 is for medical personnel to hold and is connected to the syringe 3 via the connector 2. By moving the operating handle 1, the medium can be pumped into the balloon 16 and pressure can be applied or depressurized to the balloon 16, causing the balloon 16 to expand or contract.

[0045] The syringe 3 has graduations 6 on its tube wall, which can visually display the volume of medium pumped into the balloon 16. The switch 4 is located on the syringe 3 and has an indicator 5 that can indicate the open and closed state of the switch 4.

[0046] One end of the first catheter 8 is connected to the outlet end of the syringe 3. One end of the second catheter 9 is connected to the other end of the first catheter 8, and the other end is connected to the balloon 16.

[0047] The syringe 3 also contains a microchannel 14, which is circular with an inner diameter of 50–200 µm, a length of 3–10 mm, and a wall thickness of <0.1 mm, without increasing the outer diameter of the syringe 3. Its inner wall is coated with a hydrophilic coating. The hydraulic diameter of the microchannel 14 is much smaller than that of a conventional blood vessel, and the flow is in a fully developed laminar flow region at an extremely low Reynolds number (Re ≪ 2000).

[0048] Figure 2 This is a schematic diagram of the monitoring unit in an embodiment of the present invention.

[0049] like Figure 2 As shown, the pressure monitoring component is disposed within the microchannel 14 and includes a pressure sensor and a temperature sensor, which are electrically connected to the microcontroller 19.

[0050] The pressure sensor includes a first pressure sensor 10 and a second pressure sensor 12, both of which are silicon piezoresistive pressure sensors.

[0051] Figure 3 This is a schematic diagram illustrating the working principle of the silicon piezoresistive pressure sensor in this embodiment of the invention.

[0052] like Figure 3 As shown, a silicon piezoresistive pressure sensor is a sensor made using the piezoresistive effect of single-crystal silicon material and integrated circuit technology. It converts pressure changes into resistance changes by utilizing the piezoresistive effect of semiconductor material (silicon), and then obtains the corresponding electrical signal through circuit measurement, which is transmitted to the pressure digital display device through the chip.

[0053] When a single-crystal silicon material is subjected to force, the crystal lattice deforms, causing charge carriers to scatter from one energy valley to another. This alters the carrier mobility, perturbing the average longitudinal and lateral charge carrier amounts, thus changing the resistivity of silicon (piezoresistive effect). Furthermore, four equivalent resistors are diffused onto a single-crystal silicon substrate using integrated circuit technology, forming a Wheatstone bridge (R1-R4 are used to convert the resistance difference into a differential voltage). Due to the piezoresistive effect, the diffused resistance value on the diaphragm changes, causing the bridge to become unbalanced and output a voltage signal proportional to the stress. This weak voltage signal is amplified and calibrated using a standard pressure for pressure detection.

[0054] Figure 4 This is a schematic diagram illustrating the principle of the temperature compensation method in an embodiment of the present invention.

[0055] Figure 5 This is a schematic diagram of the structure of the first pressure sensor and the first temperature sensor in an embodiment of the present invention.

[0056] like Figure 4-5 As shown, the temperature sensor includes two first temperature sensors 11 and two second temperature sensors 13, all of which are forward-biased silicon micro diodes, disposed in the non-diaphragm area of ​​the chip of the silicon piezoresistive pressure sensor (i.e., the first temperature sensor 11 is disposed in the non-diaphragm area of ​​the chip of the first pressure sensor 10, and the second temperature sensor 13 is disposed in the non-diaphragm area of ​​the chip of the second pressure sensor 12), and is used to monitor changes in ambient temperature T and perform temperature compensation.

[0057] Specifically, because silicon piezoresistive pressure sensors use silicon semiconductor materials, their sensitivity changes with temperature. As the temperature rises, the piezoresistive coefficient decreases, and the sensitivity drops. Therefore, during this process, the silicon micro-diode on the chip monitors the change in ambient temperature T in real time and performs temperature compensation.

[0058] Specifically, the temperature compensation method is as follows: the forward voltage drop V_F of the silicon micro-diode decreases linearly with increasing temperature (≈ −2 mV / °C). This V_F temperature signal is first amplified by a low-noise amplifier and then transmitted to the second ADC. To ensure the consistency of pressure and temperature data in time, the system is designed to synchronously sample the pressure signal channel and the temperature signal channel (i.e., synchronous sampling by two ADCs), with a sampling time alignment error of < 1 ms between the two channels. The pressure and temperature data acquired through synchronous sampling are transmitted to the microcontroller 19 for real-time processing. Within the microcontroller 19, a two-dimensional calibration model of "temperature-zero point-sensitivity" is used to make real-time corrections to the pressure output, and the corrected output minimizes errors to the greatest extent.

[0059] Figure 6This is a schematic diagram of the internal structure of the microchannel in an embodiment of the present invention.

[0060] like Figure 2 and 6 As shown, the first pressure sensor 10 is located at the end of the microchannel 14 near the operating handle 1, and the second pressure sensor 12 is located at the end of the microchannel 14 away from the operating handle 1, for monitoring the pressure difference ΔP between the two ends of the microchannel 14. The chips of the two pressure sensors are encapsulated with medical epoxy or silicone on the side near the microchannel 14, and Parylene-C encapsulation on the other side to ensure that no media leakage occurs.

[0061] According to Hagen-Poiseuille's law, the volumetric flow rate Q is linearly related to ΔP:

[0062] Q = (π D 4 ) / (128 L) · ΔP / μ(T) (1)

[0063] Wherein, the geometric constant K_geo = πD 4 / (128 L) is determined in one step by the processing dimensions of microchannel 14, and μ(T) is the dynamic viscosity of the liquid, which varies exponentially with temperature:

[0064] μ(T) = μ_ref · exp[γ (T_ref - T)] (2)

[0065] The microcontroller 19 inputs ΔP after temperature drift correction into equations (1) and (2), and completes zero-point sensitivity compensation and viscosity correction within a 1 ms period, outputting the temperature-compensated flow rate value in real time. The overall system error is ≤ ±2 %FS.

[0066] Meanwhile, when the microcontroller 19 processes the pressure data, it can convert the pressure data into the volume of the balloon 16 according to Boyle's law.

[0067] The flow monitoring sensor 17 is a MEMS hot-film chip, integrating a silicon diode and a hot-film. The MEMS hot-film chip is encapsulated in medical-grade epoxy resin and embedded within the wall of the syringe 3. The surface of the MEMS hot-film chip is flush with the inner wall of the syringe 3. The MEMS hot-film chip is electrically connected to the microcontroller 19.

[0068] The formula for calculating flow rate is:

[0069]

[0070] Where Q: volumetric flow rate mL / min, k: flow coefficient, ΔT: temperature difference between the thermal film and the environment °C, P heater Heating power (mW, kWh)loss Heat loss coefficient (mW / ℃)

[0071] Based on the hot-film / hot-wire principle, flow rate is calculated by measuring the heat carried away by the fluid during flow. The accuracy of flow rate measurement using the heat method is affected by fluid temperature because the fluid's specific heat capacity and thermal conductivity change with temperature. To ensure measurement accuracy, temperature compensation is required. The temperature compensation principle of the silicon diode in this case is the same as that of the silicon microdiode in silicon piezoresistive pressure sensors.

[0072] The pressure pump unit 100 also features a power module, which is a rechargeable lithium-ion battery. It supports fast charging via USB-C interface and provides a battery life of over 8 hours, meeting the needs of long-duration surgeries.

[0073] Working principle: During surgery, medical staff hold the operating handle 1 and turn on the switch 4. By moving the operating handle 1, saline, contrast agent, or other media are pumped into the balloon 16, and pressure is applied or depressurized to inflate or deflate the balloon 16. During this process, the first pressure sensor 10, the second pressure sensor 12, and the flow monitoring sensor 17 transmit real-time monitored data to the microcontroller 19 for processing. The processed data is then transmitted to the display screen 23, allowing medical staff to view the pressure, flow rate, volume of the pumped media, and the volume of the balloon 16 in real time.

[0074] When data anomalies occur, display screen 23 shows alarm information, indicating abnormal conditions such as excessive pressure or abnormal flow, and can display pressure and flow curves for the past 10 minutes. Simultaneously, when pressure or flow exceeds preset thresholds, it will alert the doctor through both sound and vibration alarms to ensure the safety of the surgical procedure. The sound alarm emits an audible alert through a speaker, while the vibration alarm provides tactile feedback through a vibration motor. This dual alarm mechanism ensures that the doctor receives timely alerts in any situation.

[0075] In this invention, the microcontroller 19 supports NFC functionality. The stored data can be read via an NFC reader. Post-operatively, the card information is read from the reader and transmitted to a computer database, assisting in the establishment of a balloon dilation information database system. This invention writes real-time pressure, flow rate data, and alarm information into the MCU storage module. This data can be transmitted to an external display via NFC, and post-operatively, other devices can easily export the stored data via the NFC chip for database construction and analysis.

[0076] This embodiment tests the output stability and accuracy of the pressure monitoring component and flow monitoring sensor 17 used in the pressure pump device 100, and evaluates the safety of the pressure pump device 100.

[0077] Pressure sensor pressure accuracy test

[0078] The testing steps for the first pressure sensor 10 and the second pressure sensor 12 are the same. The first pressure sensor 10 will be used as an example for explanation.

[0079] The uninflated balloon 16 is connected to the first pressure sensor 10, the standard pressure gauge, and the pressure pump through a four-way pipe to form a closed port.

[0080] First, test the effectiveness of the connection by slowly pressing the pressure pump handle to increase the pressure inside the entire device. Observe the overall smoothness of the device. If the smoothness is good, release the pressure and proceed with subsequent experiments.

[0081] Immerse the balloon in a constant temperature water bath at 37°C, allow the device to equilibrate in the water bath for 2 minutes, and continue the experiment after the temperature has stabilized.

[0082] Slowly press the pressure pump to start pressurizing, and pause to observe the values ​​of the two testing devices at different standard atmospheric pressures (atm).

[0083] The standard pressure gauge outputs 0, 2, 4, 6, 8, and 10 atm as pause points. At each pause, the pressure value output by the first pressure sensor 10 is read, the data is recorded, and the error between the two is calculated.

[0084] Experimental results show that repeated tests and statistical analysis were conducted on the output of the first pressure sensor 10 at different set pause points (0, 2, 4, 6, 8, 10 atm). There were no statistically significant differences between the measured values ​​and the set values ​​at each pause point (P > 0.05), indicating that the first pressure sensor 10 has stable output across the entire measurement range and exhibits small measurement error.

[0085] Flow sensor flow accuracy test

[0086] The unfilled balloon 16 with the installed flow monitoring sensor 17, the injection pump, an exhaust pipe, and the pressure pump are connected to form a closed port via a four-way pipe.

[0087] First, test the effectiveness of the connection by slowly pressing the pressure pump handle to increase the pressure inside the entire device. Observe the overall smoothness of the device. If the smoothness is good, release the pressure and proceed with the subsequent experiments.

[0088] Before the test begins, all the air in the exhaust pipe cavity is purged. Then, the air in the entire device is slowly pushed into the pre-set exhaust pipe by pushing the injection pump.

[0089] The syringe pump is set to different pumping speeds: 5, 10, 15, and 20 ml / min. Each speed is set to run for 60 seconds.

[0090] Each time the syringe pump is started, record the pumping speed and time, observe the value of the flow monitoring sensor 17 on the display, and record its reading.

[0091] After data collection, statistical analysis was performed to calculate the average flow rate and percentage error of the 10 samples and to evaluate linearity.

[0092] Table 1. Statistics of flow rate results displayed by the flow monitoring sensor at different set flow rates.

[0093]

[0094]

[0095] Figure 7 This is a graph showing the regression analysis results in an embodiment of the present invention.

[0096] As shown in Table 1 and Figure 7 As shown, repeated measurements and statistical analysis were performed on the flow monitoring sensor 17 at different set flow rates (5, 10, 15, 20 ml / min). The measured values ​​at each detection point were basically consistent with the set values, with an error range within ±2%FS. Regression analysis results showed a good linear correlation between the measured values ​​and the set values ​​(R²≈1).

[0097] No adverse events such as balloon rupture, contrast agent leakage, leakage current, or short circuit occurred during the two experiments, indicating that the device has good operational stability and electrical safety.

[0098] The role and effect of the embodiments

[0099] The novel medical balloon pressure pump device 100 according to the present invention has the following beneficial effects:

[0100] The pressure pump device 100 of the present invention includes a pump body, a monitoring unit, and a control unit. The monitoring unit includes a pressure monitoring component and a flow monitoring sensor 17. By setting up the pressure monitoring component, the volume of the balloon 16 can be monitored in real time; by setting up the flow monitoring sensor 17, the flow rate of the input medium inside the balloon 16 can be monitored in real time. The control unit is electrically connected to the pressure monitoring component and the flow monitoring sensor 17, and is used to process and display the data monitored by the pressure monitoring component and the flow monitoring sensor 17. The data transmission frequency is 10 Hz, that is, updated once every 100 milliseconds, ensuring the real-time performance and accuracy of the data. The present invention, through more precise monitoring and control, makes the operation of the pressure pump device 100 in interventional surgeries such as angioplasty more precise, reduces vascular damage and complications caused by improper pressure or volume control, and improves the success rate and safety of the surgery. The present invention upgrades the pressure display device in the prior art to a dual flow and pressure display, making the data display more intuitive and easier for doctors to monitor and analyze the data in real time.

[0101] The pressure monitoring component includes a pressure sensor and a temperature sensor. The pressure sensor is a silicon piezoresistive pressure sensor. The temperature sensor is a forward-biased silicon microdiode located in the non-diaphragm region of the silicon piezoresistive pressure sensor chip. It is used to monitor changes in the temperature environment and perform temperature compensation, preventing the sensitivity of the silicon piezoresistive pressure sensor from changing due to temperature, and ensuring the accuracy of the monitored pressure data.

[0102] The syringe 3 contains a microchannel 14. A first pressure sensor 10 is located at the end of the microchannel 14 near the operating handle 1, and a second pressure sensor 12 is located at the end of the microchannel 14 away from the operating handle 1. These sensors monitor the pressure difference ΔP between the two ends of the microchannel 14 and convert ΔP into the flow rate of the medium according to the Hagen-Poiseuille law. In existing balloon pressure pumps, directly measuring the liquid volume or instantaneous flow rate within the balloon is very difficult. However, by designing the microchannel 14 and utilizing the small pressure difference generated at its two ends, the flow rate measurement problem is transformed into a more easily solved pressure difference measurement problem. This allows for high-precision calculation of the volumetric flow rate of the liquid medium, improving the accuracy of monitoring.

[0103] The flow monitoring sensor 17 is a MEMS hot-film chip that integrates a silicon diode and a hot-film. The MEMS is embedded in the wall of the syringe 3, and the surface of the MEMS hot-film chip is flush with the inner wall of the syringe 3, thereby obtaining the degree of blood vessel lumen acquisition and assisting clinicians in achieving better diagnosis and treatment.

[0104] The microcontroller 19 also includes an alarm module 20, comprising a speaker and a vibration motor. When the pressure or flow exceeds a preset threshold, it will alert the doctor through both sound and vibration alarms, ensuring the safety of the surgical procedure. The sound alarm emits an alarm sound through the speaker, while the vibration alarm provides tactile feedback through the vibration motor. This dual alarm mechanism ensures that the doctor receives timely alerts in any situation.

[0105] In this invention, the microcontroller 19 supports NFC functionality. The stored data can be read via an NFC reader. Post-operatively, the card information is read from the reader and transmitted to a computer database, assisting in the establishment of a balloon dilation information database system. This invention writes real-time pressure, flow rate data, and alarm information into the MCU storage module. This data can be transmitted to an external display via NFC, and post-operatively, other devices can easily export the stored data via the NFC chip for database construction and analysis.

[0106] Those skilled in the art should understand that this invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to this invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A novel medical balloon pressure pump device, characterized in that, include: The pump body, used to pump the medium into the balloon and pressurize or depressurize the balloon to expand or retract it, includes a syringe; The monitoring unit includes a pressure monitoring component for monitoring the volume of the balloon and a flow monitoring sensor for monitoring the volume of the input medium inside the balloon, both located inside the pump body. The control unit, electrically connected to the pressure monitoring component and the flow monitoring sensor, is used to process and display the data monitored by the pressure monitoring component and the data monitored by the flow monitoring sensor; The first catheter has one end connected to the outlet end of the syringe; The second catheter has one end connected to the other end of the first catheter and the other end connected to the balloon.

2. The novel medical balloon pressure pump device according to claim 1, characterized in that: in, The pump body also includes: An operating handle is provided for medical personnel to hold and move to pump the medium into the balloon, and to pressurize or depressurize the balloon, causing it to expand or contract. The syringe is connected to the operating handle. A switch is provided on the syringe.

3. The novel medical balloon pressure pump device according to claim 1, Its features are: The pressure monitoring component is disposed within the syringe, and the pressure monitoring component includes: The pressure sensor is a silicon piezoresistive pressure sensor. The temperature sensor is a forward-biased silicon microdiode located in the non-diaphragm region of the pressure sensor chip, used to monitor changes in ambient temperature T and perform temperature compensation.

4. The novel medical balloon pressure pump device according to claim 3, characterized in that: in, The syringe is also equipped with a microchannel, and pressure sensors are installed at both ends of the microchannel to monitor the pressure difference ΔP between the two ends of the microchannel.

5. The novel medical balloon pressure pump device according to claim 4, characterized in that: in, The volumetric flow rate Q is linearly related to ΔP: Q = (π D 4 ) / (128 L) ΔP / μ(T) (1) Wherein, the geometric constant K_geo = πD 4 / (128 L); K_geo is determined by the processing dimensions of the microchannel; D is the diameter of the microchannel; L is the length of the microchannel; μ(T) is the dynamic viscosity of the liquid, which varies exponentially with temperature: μ(T) = μ_ref · exp[γ (T_ref - T)] (2) After correcting for temperature drift, ΔP is substituted into equations (1) and (2) to complete zero-point sensitivity compensation and viscosity correction within a 1 ms period, and output the temperature-compensated flow rate value in real time.

6. The novel medical balloon pressure pump device according to claim 4, characterized in that: in, The microchannel has an inner diameter of 50–200 µm, a length of 3–10 mm, and a wall thickness of < 0.1 mm, with its inner wall coated with a hydrophilic coating.

7. The novel medical balloon pressure pump device according to claim 6, characterized in that: in, The chip is encapsulated with medical epoxy or silicone on one side near the microchannel, and Parylene-C is used on the other side.

8. The novel medical balloon pressure pump device according to claim 1, characterized in that: in, The flow monitoring sensor is a MEMS hot-film chip that integrates a silicon diode and a hot-film. The MEMS hot-film chip is encapsulated in medical epoxy resin and embedded in the syringe wall.

9. The novel medical balloon pressure pump device according to claim 8, characterized in that: in, The formula for calculating flow rate is: ， Where Q: volumetric flow rate mL / min, k: flow coefficient, ΔT: temperature difference between the thermal film and the environment °C, P heater Heating power (mW, kJ) loss Heat loss coefficient (mW / ℃).

10. The novel medical balloon pressure pump device according to claim 1, characterized in that: in, The control unit includes a display screen and a microcontroller (MCU), both of which are electrically connected to the pressure monitoring component and the flow monitoring sensor. The microcontroller is mounted on the display screen.

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