Single-pump dialysis machine automatic priming detection method and system

Abstract

The present application relates to the field of medical apparatus and instruments, more particularly to a single-pump dialysis machine automatic priming detection method and system, the specific steps comprising: dialysate is used to automatically prime the single-pump dialysis machine through the series connection of the ultra-clean filter; the single-pump dialysis machine comprises a dialyzer, an arterial pipeline and a venous pipeline; after the priming fluid enters the single-pump dialysis machine, the alarm system is used to monitor and warn the leakage existing in the venous pipeline and the arterial pipeline; the present application is used to solve the problem that the dialysate in the single-pump dialysis device does not meet the replacement fluid requirements, affecting the replacement effect; manual priming is prone to errors, physiological saline bags are consumed in large quantities; and the air tightness cannot be detected; the ultra-clean filter is used to reach the priming fluid standard, improve the priming effect, reduce the use of physiological saline in the traditional steps, and reduce the use cost; the automatic priming can be completed in both hemodialysis (HD) and hemodiafiltration (HDF) modes; the alarm system is used for leakage monitoring, avoiding serious accidents caused by improper use.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and more specifically, to an automatic pre-fill detection method and system for a single-pump dialysis machine. Background Technology

[0002] To remove metabolic waste and harmful bioactive substances and maintain homeostasis within the body, the most common dialysis equipment includes three modes: hemodialysis (HD), hemodiafiltration (HDF), and hemoperfusion (HP).

[0003] Pre-filling the tubing in the dialysis equipment before treatment is a necessary procedure. The purposes of pre-filling include: purging the dialyzer and tubing of gas to prevent gas embolism; wetting the dialysis membrane to facilitate full contact between blood and solute during dialysis, improving blood membrane biocompatibility, achieving better clearance, and reducing the occurrence of blood membrane reactions; and removing particulate contamination from the dialysis tubing to minimize the entry of particles carried by the extracorporeal circulation tubing into the body through blood circulation, which could cause inflammation and harm the patient's health.

[0004] Current single-pump dialysis equipment only supports HD mode and not online HDF mode. Therefore, pre-filling relies on medical staff manually filling the tubing with saline. How to ensure the dialysate meets the replacement fluid supply requirements in single-pump dialysis equipment, reducing patient reactions to the replacement fluid and making it more suitable for the patient's blood; and how to achieve automatic pre-filling to reduce the possibility of manual pre-filling errors, ensure the pre-filling effect of the equipment tubing, reduce the consumption of disposable saline bags, and lower the operating cost of the equipment have become pressing problems that need to be solved in current technology. Summary of the Invention

[0005] This invention aims to overcome at least one of the defects (deficiencies) of the prior art mentioned above, and provides an automatic pre-filling detection method and system for single-pump dialysis machines. This system addresses the problems of dialysate in single-pump dialysis equipment not meeting replacement fluid requirements and the inability to achieve automatic pre-filling, thus affecting the patient's blood exchange effect; manual pre-filling of single-pump dialysis equipment not only increases the possibility of operational errors but also increases the consumption of disposable saline bags, resulting in higher operating costs for dialysis equipment; the inability to detect the pre-filling status of the dialysis equipment to determine whether the pre-filling effect meets expectations; and the inability to automatically alarm and detect airtightness issues in the entire extracorporeal circulation tubing during connection and assembly or within the tubing itself.

[0006] The technical solution adopted in this invention is an automatic pre-fill detection method for a single-pump dialysis machine, wherein the specific steps include:

[0007] S1. The dialysate passes through a series of ultra-clean filters to generate ultrapure dialysate, which is used as pre-filling fluid to automatically pre-fill the entire single-pump dialysis machine.

[0008] S2. The single-pump dialysis machine includes a dialyzer, an arterial line, and a venous line. The pre-filling solution flows into the arterial line and the dialyzer and venous line respectively, and the immersion status of the two lines is detected separately.

[0009] S3. After the pre-filled solution enters the single-pump dialysis machine, the alarm system monitors and alerts staff to any leaks in the venous or arterial tubing, enabling them to detect problems promptly.

[0010] It facilitates the purification of ordinary dialysate into ultrapure dialysate through an ultra-clean filter, meeting the standards for pre-filling solution and reducing the use of physiological saline as pre-filling solution in traditional pre-filling steps; it facilitates automatic pre-filling in both hemodialysis (HD) and hemodiafiltration (HDF) modes by connecting arterial and venous tubing to the dialyzer; and it facilitates monitoring for leaks in arterial and venous tubing through an alarm system, preventing serious blood leakage accidents caused by improper use.

[0011] Furthermore, the single-pump dialysis machine in step S1 also includes a blood pump, a replacement fluid outlet, and a waste liquid outlet. The ultra-clean filter includes a first ultra-clean filter and a second ultra-clean filter. The blood pump is started before the ultra-clean filter is started. The dialysate passes through the first ultra-clean filter and the second ultra-clean filter in sequence and flows into the replacement fluid outlet and the dialyzer supply port, respectively. The waste liquid outlet is used to discharge the waste liquid from the first ultra-clean filter and the air from the intravenous tubing.

[0012] It is beneficial to ensure that the purity of the ultrapure dialysate meets the replacement standard by connecting the first and second ultrapure filters in series; it is also beneficial to start the automatic pre-filling process by turning on the blood pump. The ultrapure dialysate flows out through the replacement fluid outlet and is automatically pre-filled into the arterial line, venous line and dialyzer. Then, the air and waste liquid after pre-filling are discharged through the waste liquid outlet.

[0013] Furthermore, the specific steps for detecting the state of the arterial conduit in step S2 include:

[0014] S21. Start the ultra-clean filter. The pre-filled solution enters the arterial line through the replacement fluid outlet. The arterial line includes an arterial chamber connected between the blood pump and the dialyzer. The pre-filled solution enters the blood pump through the replacement fluid outlet and then flows out of the blood pump into the arterial chamber.

[0015] S22. During the pre-filling fluid level detection in the arterial pipeline, the flow of the pre-filling fluid is not interrupted. The arterial pipeline also includes a first level reservoir detector, a pre-pressure interface, and a negative pressure device. The first level reservoir detector is installed on the arterial reservoir and is used to detect the level of the pre-filling fluid in the arterial reservoir. The negative pressure device includes an arterial level reservoir pump and a pressure sensor, which are connected to the arterial reservoir through the pre-pressure interface. The arterial level reservoir pump is started to pump air. When the first level reservoir detector detects that the pre-filling fluid in the arterial reservoir has reached the standard line and the pressure monitoring value of the pressure sensor is stable, it is determined that the pre-filling fluid has fully wetted the arterial pipeline.

[0016] S23. If the pre-filled fluid in the arterial reservoir does not reach the standard line, and / or the pressure monitoring value of the pressure sensor is unstable, repeat steps S21 and S22 until the pre-filled fluid fully wets the arterial pipeline. At this time, stop running the arterial level reservoir pump to complete the status detection of the arterial pipeline.

[0017] It is beneficial to set pressure acquisition points when performing status detection of arterial tubing through the arterial reservoir; it is beneficial to achieve a negative pressure state by evacuating the arterial reservoir through the arterial level reservoir pump, detect the negative pressure value in the arterial reservoir through the pressure sensor, and detect whether the liquid level of the pre-filled fluid in the arterial reservoir reaches the preset standard line under the negative pressure state through the first liquid level reservoir detector, thereby determining whether the entire arterial tubing has been fully saturated.

[0018] Furthermore, the specific steps for detecting the status of the venous tubing in step S2 include:

[0019] S24. Start the ultra-clean filter. The pre-filled solution enters the venous line through the supply port of the dialyzer. The venous line includes a venous reservoir connected between the dialyzer and the waste port. After the pre-filled solution enters the venous reservoir from the dialyzer, it flows out of the venous reservoir and into the waste port.

[0020] S25. During the level detection of the pre-filled fluid in the venous tubing, the flow of the pre-filled fluid is not interrupted. The venous tubing also includes a second level reservoir detector, a venous pressure interface, and a negative pressure device. The second level reservoir detector is installed on the venous reservoir and is used to detect the level of the pre-filled fluid in the venous reservoir. The negative pressure device includes a venous level reservoir pump and a pressure sensor, which are connected to the venous reservoir through the venous pressure interface. The venous level reservoir pump is started to pump air. When the second level reservoir detector detects that the pre-filled fluid in the venous reservoir has reached the standard line and the pressure monitoring value of the pressure sensor is stable, it is determined that the pre-filled fluid has fully wetted the venous tubing.

[0021] S26. If the pre-filled fluid in the venous reservoir does not reach the standard line, and / or the pressure monitoring value of the pressure sensor is unstable, repeat steps S24 and S25 until the pre-filled fluid fully wets the venous tubing. At this point, stop running the venous level reservoir pump to complete the status detection of the venous tubing.

[0022] It is beneficial to set pressure acquisition points when monitoring the status of the venous tubing through the venous reservoir, and to achieve a negative pressure state by evacuating the venous reservoir through the venous level reservoir pump. The negative pressure value in the venous reservoir is detected by the pressure sensor, and the liquid level of the pre-filled liquid in the venous reservoir is detected by the second liquid level reservoir detector to determine whether the liquid level of the venous reservoir reaches the preset standard line under the negative pressure state, thereby determining whether the entire venous tubing has been fully saturated.

[0023] Furthermore, the single-pump dialysis machine also includes a replacement fluid line, and the arterial line also includes an arterial pressure interface. One end of the replacement fluid line is connected to both the venous chamber and the arterial chamber through the arterial pressure interface, and the other end is connected to the replacement fluid outlet.

[0024] It is advantageous to directly provide replacement fluid that can be used for automatic pre-filling through the replacement fluid pipeline, thereby replacing the filtration function of the ultra-clean filter. The replacement fluid flows directly into the venous and arterial chambers, shortening the pre-filling time. It is also advantageous to switch between normal pre-filling and rapid pre-filling by connecting the replacement fluid outlet to the replacement pipeline and the ultra-clean filter. In normal pre-filling, the pre-filling fluid is formed by dialysis fluid filtered through the ultra-clean filter, while in rapid pre-filling, the pre-filling fluid is the replacement fluid.

[0025] Furthermore, the intravenous tubing also includes a flow-blocking clamp connected between the venous reservoir and the waste outlet, used to block the discharge from the venous reservoir and automatically detect air bubbles therein; the alarm system in step S3 is used to reduce the flow rate of the blood pump to the control value and close the flow-blocking clamp, and to measure and determine the venous pressure value in the intravenous tubing.

[0026] It is beneficial to form a closed state of the pre-filled fluid flowing in the venous tubing by using the flow-blocking clamp, and to determine whether there is a leak in the venous tubing by detecting the venous pressure value; the bubble detection device set in the flow-blocking clamp can detect whether bubbles appear when the fluid discharged from the venous pot flows through the flow-blocking clamp.

[0027] Furthermore, the judgment method steps of the alarm system include:

[0028] S31. Determine whether the venous pressure value exceeds the threshold. If not, proceed to step S32; if yes, proceed to step S33.

[0029] S32. Determine if the measurement time exceeds the set value. If not, continue with the next measurement of venous pressure. If so, send a signal to stop the blood pump and activate the alarm.

[0030] S33. Determine whether the venous pressure value exceeds the threshold. If so, send a signal to control the blood pump to stop running and proceed to step S34.

[0031] S34. Determine whether the measurement time exceeds the set value. If not, send a signal to control the blood pump to stop running and start the alarm. If yes, send a signal to indicate no leakage.

[0032] This allows for the establishment of judgment logic based on the numerical information of venous pressure and measurement time measured in the venous tubing. Different alarm states can be displayed according to different feedback states, thereby enabling timely reminders of venous tubing leaks and preventing blood leakage accidents.

[0033] Furthermore, the single-pump dialysis machine also includes a heparin pump. The pre-filled fluid in S2 flows out from the blood pump, mixes with the anticoagulant in the heparin pump, and then enters the arterial chamber.

[0034] It helps to inhibit blood clotting when flowing in a single-pump dialysis machine by using the anticoagulant in the heparin pump. The anticoagulant and prefill solution are mixed before entering the arterial chamber, which enhances the efficiency of clearing blood clots in the arterial tubing and improves the efficiency of automatic prefilling.

[0035] Furthermore, the blood pump's flow rate control value ranges from 20 to 700 ml / min; the threshold value for venous pressure ranges from 50 to 700 mmHg; and the measurement time setting value ranges from 5 to 60 seconds.

[0036] It is beneficial to achieve precise control of leaks in venous lines by using specific flow rate control ranges, specific venous pressure threshold ranges, and specific measurement time set ranges.

[0037] An automatic pre-charge detection system for a single-pump dialysis machine is also provided, comprising:

[0038] Extracorporeal circulation tubing: including arterial tubing, venous tubing, dialyzer, replacement fluid outlet and waste fluid outlet, wherein the dialyzer inlet is connected to the arterial tubing outlet, the dialyzer outlet is connected to the venous tubing inlet, the arterial tubing inlet is connected to the replacement fluid outlet, and the venous tubing outlet is connected to the waste fluid outlet;

[0039] A pre-filling device is used to generate pre-filling fluid that flows through the extracorporeal circulation tubing. The pre-filling device is connected to the arterial tubing through the replacement fluid outlet and to the venous tubing through the dialyzer.

[0040] The detection device includes a first liquid level reservoir detector and a second liquid level reservoir detector, which are used to detect the immersion status of the prefilling fluid in the arterial and venous lines, respectively; the alarm system includes a flow-blocking clamp and a control board, wherein the flow-blocking clamp is installed on the venous line and is used to detect the air pressure status of the venous line; the control board is used to control the blood pump in the arterial line to reduce the flow rate, control the flow-blocking clamp to close, and issue an alarm when a leak occurs in the extracorporeal circulation line.

[0041] It facilitates the pre-filling of the extracorporeal circulation circuit with pre-filling fluid generated by the pre-filling device, enabling single-pump dialysis machines to achieve automatic pre-filling function in hemodialysis (HD) mode. This reduces the disposable consumption of saline bags, lowers the possibility of errors in manual pre-filling, ensures the hemodialysis effect for patients, and reduces operating costs. It also facilitates the detection of the pre-filling fluid level through the detection device. The pre-filling fluid filling the extracorporeal circulation tubing is sealed by the flow clamp, making it easy to detect leaks caused by damage to the extracorporeal circulation tubing or by medical staff forgetting to close the clamp.

[0042] Compared with the prior art, the beneficial effects of the present invention are as follows: Ordinary dialysate is purified into ultrapure dialysate through an ultra-clean filter to meet the standards for pre-filling solution, improving the pre-filling effect and reducing the use of physiological saline as the pre-filling solution in the traditional pre-filling step, thus reducing operating costs; Automatic pre-filling can be completed in both hemodialysis (HD) and hemodiafiltration (HDF) modes through the connection of arterial and venous tubing to the dialyzer; Leakage monitoring is performed through an alarm system to avoid serious blood leakage accidents caused by improper use, reducing the possibility of manual pre-filling operation errors, and timely detection of problems with poor tubing sealing, thus improving the performance of the single-pump dialysis machine. Attached Figure Description

[0043] Figure 1 This is a flowchart of the arterial and venous tubing status detection process of the present invention.

[0044] Figure 2 This is a flowchart of the alarm system detection process of the present invention.

[0045] Figure 3 This is a schematic diagram of the automatic pre-charge detection system of the present invention.

[0046] Explanation of reference numerals in the attached diagram:

[0047] Dialyzer 1000, supply port 1100, return port 1200;

[0048] Extracorporeal circulation circuit 2000, arterial tubing 2100, arterial reservoir 2130, arterial pressure interface 2131, first level reservoir detector 2132, blood pump 2140, heparin pump 2150, venous tubing 2200, venous reservoir 2230, venous pressure interface 2231, second level reservoir detector 2232, flow clamp 2240, pre-filled end 2500, waste outlet 2600, first ultra-clean filter 2700, second ultra-clean filter 2800. Detailed Implementation

[0049] The accompanying drawings are for illustrative purposes only and should not be construed as limiting the invention. To better illustrate the following embodiments, some parts in the drawings may be omitted, enlarged, or reduced, and do not represent the actual product dimensions; it is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings. Example 1

[0050] like Figure 1-2 As shown, this embodiment provides an automatic pre-charge detection method for a single-pump dialysis machine, the specific steps of which include:

[0051] S1. The dialysate passes through a series of ultra-clean filters to generate ultrapure dialysate, which is used as pre-filling fluid to automatically pre-fill the entire single-pump dialysis machine.

[0052] S2. The single-pump dialysis machine includes a dialyzer, an arterial line 2100, and a venous line 2200. Prefilling solution flows into the arterial line 2100 and the dialyzer and venous line 2200 respectively, and the immersion status of the two lines is detected respectively.

[0053] S3. After the pre-filled solution enters the single-pump dialysis machine, the alarm system monitors and alerts staff to any leaks in the venous line 2200 and the arterial line 2100, enabling staff to detect problems in a timely manner.

[0054] The single-pump dialysis machine in step S1 also includes a blood pump 2140, a replacement fluid outlet, and a waste liquid outlet 2600. The ultra-clean filter includes a first ultra-clean filter 2700 and a second ultra-clean filter 2800. The blood pump 2140 is started before the ultra-clean filter is started. The dialysate passes through the first ultra-clean filter 2700 and the second ultra-clean filter 2800 in sequence and flows into the replacement fluid outlet and the dialyzer supply port, respectively. The waste liquid outlet 2600 is used to discharge the waste liquid from the first ultra-clean filter 2700 and the air from the intravenous tubing 2200.

[0055] In this embodiment, during dialysis treatment, the arterial line 2100 connects to the patient's artery, and the venous line 2200 connects to the patient's vein. Blood flows out after passing through the arterial line 2100, dialyzer 1000, and venous line 2200. Solute exchange occurs between the blood and dialysate in the dialyzer 1000, achieving the therapeutic effect. The first ultra-clean filter 2700 and the second ultra-clean filter 2800 are the same type of filter; dual filtration is used to filter out the dialysate to form ultrapure dialysate for use as pre-filling fluid, improving the pre-filling effect of the single-pump dialysis machine. The arterial line 2100 is equipped with a blood pump 2140 to power the fluid.

[0056] The specific steps for the status detection of arterial line 2100 in step S2 include:

[0057] S21. Start the ultra-clean filter. The pre-filled solution enters the arterial line 2100 through the replacement fluid outlet. The arterial line 2100 includes an arterial chamber 2130 connected between the blood pump 2140 and the dialyzer. After the pre-filled solution enters the blood pump 2140 through the replacement fluid outlet, it flows out of the blood pump 2140 and into the arterial chamber 2130.

[0058] S22. During the level detection of the pre-filled fluid in the arterial line 2100, the flow of the pre-filled fluid is not interrupted. The arterial line 2100 also includes a first level reservoir detector 2132, a pre-pressure interface, and a negative pressure device. The first level reservoir detector 2132 is installed on the arterial reservoir 2130 and is used to detect the level of the pre-filled fluid in the arterial reservoir 2130. The negative pressure device includes an arterial level reservoir pump and a pressure sensor, which are connected to the arterial reservoir 2130 through the pre-pressure interface. The arterial level reservoir pump is started to pump air. When the first level reservoir detector 2132 detects that the pre-filled fluid in the arterial reservoir 2130 has reached the standard line and the pressure monitoring value of the pressure sensor is stable, it is determined that the pre-filled fluid has fully wetted the arterial line 2100.

[0059] S23. If the pre-filled fluid in the arterial reservoir 2130 does not reach the standard line, and / or the pressure monitoring value of the pressure sensor is unstable, repeat steps S21 and S22 until the pre-filled fluid fully wets the arterial line 2100. At this time, stop running the arterial level reservoir pump and complete the status detection of the arterial line 2100.

[0060] The specific steps for the status detection of the venous line 2200 in step S2 include:

[0061] S24. Start the ultra-clean filter. The pre-filled solution enters the venous line 2200 through the supply port of the dialyzer. The venous line 2200 includes a venous reservoir 2230 connected between the dialyzer and the waste port 2600. After the pre-filled solution enters the venous reservoir 2230 from the dialyzer, it flows out from the venous reservoir 2230 and into the waste port 2600.

[0062] S25. During the level detection of the pre-filled fluid in the intravenous line 2200, the flow of the pre-filled fluid is not interrupted. The intravenous line 2200 also includes a second level reservoir detector 2232, an intravenous pressure interface 2231, and a negative pressure device. The second level reservoir detector 2232 is installed on the intravenous reservoir 2230 and is used to detect the level of the pre-filled fluid in the intravenous reservoir 2230. The negative pressure device includes an intravenous level reservoir pump and a pressure sensor. It is connected to the intravenous reservoir 2230 through the intravenous pressure interface 2231. The intravenous level reservoir pump is started to pump air. When the second level reservoir detector 2232 detects that the pre-filled fluid in the intravenous reservoir 2230 has reached the standard line and the pressure monitoring value of the pressure sensor is stable, it is determined that the pre-filled fluid has fully wetted the intravenous line 2200.

[0063] S26. If the pre-filled fluid in the venous reservoir 2230 does not reach the standard line, and / or the pressure monitoring value of the pressure sensor is unstable, repeat steps S24 and S25 until the pre-filled fluid fully wets the venous tubing 2200. At this time, stop running the venous level reservoir pump and complete the status detection of the venous tubing 2200.

[0064] In this embodiment, the arterial pipeline 2100 is equipped with an arterial reservoir 2130, which has an arterial pressure interface 2131 and a first liquid level reservoir detector 2132. The arterial pressure interface 2131 is connected to an air inlet. The venous pipeline 2200 is equipped with a venous reservoir 2230, which has a venous pressure interface 2231 and a second liquid level reservoir detector 2232. The venous pressure interface 2231 is connected to an air inlet. The first liquid level reservoir detector 2132 and the second liquid level reservoir detector 2232 can detect the presence of gas. If gas is detected, the arterial liquid level reservoir pump and the venous liquid level reservoir pump respectively create negative pressure at the arterial pressure interface 2131 and the venous pressure interface 2231 to expel the gas, achieving sufficient venting without affecting the liquid path.

[0065] The single-pump dialysis machine also includes a replacement fluid line, and the arterial line 2100 also includes an arterial pressure interface 2131. One end of the replacement fluid line is connected to both the venous reservoir 2230 and the arterial reservoir 2130 through the arterial pressure interface 2131, and the other end is connected to the replacement fluid outlet.

[0066] In this embodiment, during dialysis treatment, the replacement fluid line is simultaneously connected to the arterial reservoir 2130 and the venous reservoir 2230 via the arterial pressure interface 2131 to provide pre-filling fluid. This automatic pre-filling system for the dialysis machine utilizes the pre-filling fluid end 2500 originally used for dialysis treatment and the replacement fluid line, placing them in the same location, simplifying the pre-filling operation and making it convenient for medical staff to use.

[0067] The intravenous tubing 2200 also includes a flow-blocking clamp 2240 connected between the venous reservoir 2230 and the waste outlet 2600, used to block the discharge from the venous reservoir 2230 and automatically detect air bubbles therein; the alarm system in step S3 is used to reduce the flow rate of the blood pump 2140 to the control value and close the flow-blocking clamp 2240, and to measure and determine the venous pressure value in the intravenous tubing 2200.

[0068] In this embodiment, the flow-blocking clamp 2240 not only serves the ordinary function of blocking the flow of the pipeline, but also detects the presence of air bubbles in the pipeline. The flow-blocking clamp 2240 is installed on the drain pipe from the venous reservoir 2230 to the waste liquid outlet 2600. When the flow-blocking clamp 2240 is closed, it does not affect the flow of pre-filled fluid in the venous pipeline 2200 and the arterial pipeline 2100 before the flow-blocking clamp 2240, which facilitates the detection of the airtightness of the arterial pipeline 2100 and the venous pipeline 2200 before the flow-blocking clamp 2240.

[0069] The judgment method of the alarm system includes the following steps:

[0070] S31. Determine whether the venous pressure value exceeds the threshold. If not, proceed to step S32; if yes, proceed to step S33.

[0071] S32. Determine if the measurement time exceeds the set value. If not, continue with the next measurement of venous pressure. If so, send a signal to control blood pump 2140 to stop running and activate the alarm.

[0072] S33. Determine whether the venous pressure value exceeds the threshold. If so, send a signal to control the blood pump 2140 to stop running and proceed to step S34.

[0073] S34. Determine whether the measurement time exceeds the set value. If not, send a signal to control the blood pump 2140 to stop running and start the alarm prompt; if so, send a signal to show that there is no leakage.

[0074] The single-pump dialysis machine also includes a heparin pump 2150. The pre-filled fluid in S2 flows out from the blood pump 2140, mixes with the anticoagulant in the heparin pump 2150, and then enters the arterial chamber 2130.

[0075] In this embodiment, the anticoagulant in the heparin pump 2150 is connected between the blood pump 2140 and the arterial chamber 2130. The anticoagulant can clean up the blood clots that have been deposited in the arterial line 2100 before automatic pre-filling.

[0076] The blood pump 2140 has a flow rate control range of 20-700 ml / min; the venous pressure threshold range is 50-700 mmHg; and the measurement time setting range is 5-60 seconds.

[0077] In this embodiment, when the pre-filled fluid reaches the target pre-filled volume, the flow rate of the blood pump 2140 is reduced to 120 ml / min, and the flow clamp 2240 is closed. The venous pressure value is measured at the venous pressure port 2231. If the venous pressure value is greater than or equal to 250 mmHg, the operation of the blood pump 2140 is stopped. The venous pressure value is continuously measured at the venous pressure port 2231. If the venous pressure value is less than 250 mmHg, and simultaneously, the venous pressure value measured in the venous reservoir 2230 is also less than 250 mmHg, and no increase in venous pressure occurs within the same 15 seconds, the operation of the blood pump 2140 is stopped, and a leak alarm is triggered to indicate a leak in the pipeline. If the venous pressure value is greater than 200 mmHg and the measurement time exceeds 10 seconds, the airtightness is deemed acceptable.

[0078] This embodiment also includes a controller (not shown) and an operation panel (not shown). The controller has an automatic pre-filling mode for timed and quantitative control of the inflow and outflow of pre-filling fluid. The operation panel is used to input signals to the controller. Medical staff can input signals to the controller through the operation panel to control the operation of the single-pump dialysis machine's automatic pre-filling system, including but not limited to starting, pausing, and ending pre-filling. Its high degree of automation saves medical staff operating time, and the precise timing and quantitative control reduces errors, minimizing potential human error and greatly improving convenience and safety. Example 2

[0079] like Figure 3 As shown, this embodiment provides an automatic pre-charge detection system for a single-pump dialysis machine, comprising:

[0080] Extracorporeal circulation tubing 2000 includes an arterial tubing 2100, a venous tubing 2200, a dialyzer, a replacement fluid outlet, and a waste fluid outlet 2600. The inlet of the dialyzer is connected to the outlet of the arterial tubing 2100, the outlet of the dialyzer is connected to the inlet of the venous tubing 2200, the inlet of the arterial tubing 2100 is connected to the replacement fluid outlet, and the outlet of the venous tubing 2200 is connected to the waste fluid outlet 2600.

[0081] A pre-filling device is used to generate pre-filling fluid that flows through the extracorporeal circulation tubing. The pre-filling device is connected to the arterial tubing 2100 through the replacement fluid outlet and to the venous tubing 2200 through the dialyzer.

[0082] The detection device includes a first liquid level reservoir detector 2132 and a second liquid level reservoir detector 2232, which are used to detect the immersion status of the prefilled fluid in the arterial line 2100 and the venous line 2200, respectively.

[0083] The alarm system includes a flow-blocking clamp 2240 and a control board. The flow-blocking clamp 2240 is installed on the venous line 2200 and is used to detect the air pressure status of the venous line 2200. The control board is used to control the blood pump 2140 in the arterial line 2100 to reduce the flow rate, control the flow-blocking clamp 2240 to close, and issue an alarm when a leak occurs in the extracorporeal circulation line.

[0084] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the technical solution of the present invention, and are not intended to limit the specific implementation of the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the claims of the present invention should be included within the protection scope of the claims of the present invention.

Claims

1. An automatic pre-charge detection method for a single-pump dialysis machine, characterized in that, The specific steps include: S1. The dialysate passes through a series of ultra-clean filters to generate ultrapure dialysate, which is used as pre-filling fluid to automatically pre-fill the entire single-pump dialysis machine. S2. A single-pump dialysis machine includes a dialyzer, an arterial line, and a venous line. Prefill solution flows into the arterial line and the dialyzer and venous line respectively, and the immersion status of the two lines is detected separately. S3. After the pre-filled solution enters the single-pump dialysis machine, the alarm system monitors and alerts staff to any leaks in the venous and arterial tubing, enabling them to detect problems promptly. The single-pump dialysis machine in step S1 also includes a blood pump, a replacement fluid outlet, and a waste liquid outlet. The ultra-clean filter includes a first ultra-clean filter and a second ultra-clean filter. The blood pump is started before the ultra-clean filter is started. The dialysate passes through the first ultra-clean filter and the second ultra-clean filter in sequence and flows into the replacement fluid outlet and the dialyzer supply port, respectively. The waste liquid outlet is used to discharge the waste liquid from the first ultra-clean filter and the air from the intravenous tubing. The specific steps for detecting the status of the arterial conduit in step S2 include: S21. Start the ultra-clean filter. The pre-filled solution enters the arterial line through the replacement fluid outlet. The arterial line includes an arterial chamber connected between the blood pump and the dialyzer. The pre-filled solution enters the blood pump through the replacement fluid outlet and then flows out of the blood pump into the arterial chamber. S22. During the level detection of the pre-filled fluid in the arterial pipeline, the flow of the pre-filled fluid is not interrupted. The arterial pipeline also includes a first level reservoir detector, a pre-pressure interface, and a negative pressure device. The first level reservoir detector is installed on the arterial reservoir and is used to detect the level of the pre-filled fluid in the arterial reservoir. The negative pressure device includes an arterial level reservoir pump and a pressure sensor, which are connected to the arterial reservoir through the pre-pressure interface. The arterial level reservoir pump is started to pump air. When the first level reservoir detector detects that the pre-filled fluid in the arterial reservoir has reached the standard line and the pressure monitoring value of the pressure sensor is stable, it is determined that the pre-filled fluid has fully wetted the arterial pipeline. S23. If the pre-filled fluid in the arterial chamber does not reach the standard line, and / or the pressure monitoring value of the pressure sensor is unstable, repeat steps S21 and S22 until the pre-filled fluid fully wets the arterial pipeline. At this time, stop running the arterial fluid level pump to complete the status detection of the arterial pipeline. The intravenous tubing also includes a flow-blocking clamp connected between the venous reservoir and the waste outlet, used to block the discharge from the venous reservoir and automatically detect air bubbles therein; the alarm system in step S3 is used to reduce the flow rate of the blood pump to the control value and close the flow-blocking clamp, and to measure and determine the venous pressure value in the intravenous tubing; The judgment method of the alarm system includes the following steps: S31. Determine whether the venous pressure value exceeds the threshold. If not, proceed to step S32; if yes, proceed to step S33. S32. Determine if the measurement time exceeds the set value. If not, continue with the next measurement of venous pressure. If so, a signal is sent to stop the blood pump and an alarm is activated; S33. Determine if the venous pressure exceeds the threshold. If so, a signal is sent to stop the blood pump and proceed to step S34; S34. Determine if the measurement time exceeds the set value. If not, send a signal to stop the blood pump and activate the alarm; if so, send a signal to indicate no leakage. The specific steps for detecting the status of the venous tubing in step S2 include: S24. Start the ultra-clean filter. The pre-filled solution enters the venous line through the supply port of the dialyzer. The venous line includes a venous reservoir connected between the dialyzer and the waste port. After the pre-filled solution enters the venous reservoir from the dialyzer, it flows out of the venous reservoir and into the waste port. S25. During the level detection of the pre-filled fluid in the intravenous tubing, the flow of the pre-filled fluid is not interrupted. The intravenous tubing also includes a second level reservoir detector, a venous pressure interface, and a negative pressure device. The second level reservoir detector is installed on the intravenous reservoir and is used to detect the level of the pre-filled fluid in the intravenous reservoir. The negative pressure device includes an intravenous level reservoir pump and a pressure sensor, which are connected to the intravenous reservoir through the venous pressure interface. The intravenous level reservoir pump is started to pump air. When the second level reservoir detector detects that the pre-filled fluid in the intravenous reservoir has reached the standard line and the pressure monitoring value of the pressure sensor is stable, it is determined that the pre-filled fluid has fully wetted the intravenous tubing. S26. If the pre-filled fluid in the venous reservoir does not reach the standard line, and / or the pressure monitoring value of the pressure sensor is unstable, repeat steps S24 and S25 until the pre-filled fluid fully wets the venous tubing. At this point, stop running the venous level reservoir pump to complete the status detection of the venous tubing.

2. The detection method according to claim 1, characterized in that, The single-pump dialysis machine also includes a replacement fluid line, and the arterial line includes an arterial pressure interface. One end of the replacement fluid line is connected to both the venous chamber and the arterial chamber through the arterial pressure interface, and the other end is connected to the replacement fluid outlet.

3. The detection method according to claim 1, characterized in that, The single-pump dialysis machine also includes a heparin pump. The pre-filled fluid in S2 flows out from the blood pump, mixes with the anticoagulant in the heparin pump, and then enters the arterial chamber.

4. The detection method according to claim 1, characterized in that, The blood pump's flow rate control range is 20-700 ml / min; the venous pressure threshold range is 50-700 mmHg; and the measurement time setting range is 5-60 seconds.

5. An automatic pre-charge detection system for a single-pump dialysis machine, applied to the automatic pre-charge detection method for a single-pump dialysis machine as described in any one of claims 1 to 4, characterized in that, include: Extracorporeal circulation tubing: includes arterial tubing, venous tubing, dialyzer, replacement fluid outlet, and waste fluid outlet. The dialyzer inlet is connected to the outlet of the arterial tubing, the dialyzer outlet is connected to the inlet of the venous tubing, the arterial tubing inlet is connected to the replacement fluid outlet, and the venous tubing outlet is connected to the waste liquid outlet. A pre-filling device is used to generate pre-filling fluid that flows through the extracorporeal circulation tubing. The pre-filling device is connected to the arterial tubing through the replacement fluid outlet and to the venous tubing through the dialyzer. The detection device includes a first liquid level reservoir detector and a second liquid level reservoir detector, which are used to detect the wetting status of the prefilled fluid in the arterial line and the venous line, respectively. The alarm system includes a flow-blocking clamp and a control board. The flow-blocking clamp is installed on the venous line and is used to detect the air pressure status of the venous line. The control board is used to control the blood pump in the arterial line to reduce the flow rate, control the flow-blocking clamp to close, and issue an alarm when a leak occurs in the extracorporeal circulation line.

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