Patient infusion regulation system and method

Abstract

Closed-loop systems and methods are described herein for regulating an intermittent infusion of a drug to a patient based on one or more vital signs. The dose rate of the drug can be periodically adjusted as needed to ensure that the patient's vital signs remain within a target range. Various safeguards can be used to ensure the safety and effectiveness of the closed-loop systems and methods.

Description

[0001] This application claims priority to U.S. Nonprovisional Application No. 17 / 365,730, filed July 1, 2021, which itself claims priority to U.S. Provisional Application No. 63 / 199,034, filed December 3, 2020. The entire contents of these cited external materials, and of all other cited external materials, are hereby incorporated by reference. In the event of inconsistencies between the definitions or uses of terms in the references incorporated by reference and the definitions provided herein, the definitions provided herein control. TECHNICAL FIELD

[0002] The field of the invention is closed loop infusion systems and methods, and in particular systems and methods for intravenous infusion pumps. BACKGROUND

[0003] The following description includes information that can be useful in understanding the present application. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed application, or that any patentable prior art has been

[0004] Maintaining a patient’s blood pressure or other vital signs can be difficult, and if not well controlled, can impact the patient’s health. Hypotension often occurs during surgery, and this hypotension can have a negative impact on patient outcomes. For example, patients who experience a mean arterial pressure (MAP) of less than 55-65 mmHg for only 1 minute during surgery have a higher probability of death than patients whose blood pressure remains stable.

[0005] Unfortunately, manually controlling medications to maintain blood pressure and other vital signs during surgery can be challenging. Optimization of blood pressure or other vital signs requires repeated measurements of the patient’s vital signs, and frequent manual adjustments to medication dose rates. Since this manual adjustment often requires the medical staff’s constant attention, it is cost prohibitive and difficult to achieve.

[0006] Figure 1 A typical workflow for manually maintaining a patient’s vital signs is shown. A nurse or other medical staff member views the patient’s vital signs, for example, on a monitor, and then manually adjusts the medication dose rate being administered to the patient. Since the medical staff member often cares for multiple patients at a time, the patient’s vital signs are checked periodically but infrequently, missing opportunities for further correction. In addition, arbitrary adjustments can be made based on a snapshot view of the patient’s vital signs.

[0007] Manual control of blood pressure often results in patients being outside of the patient's target range for a significant amount of time. For example, one study found that manual control of blood pressure resulted in patients being outside of the target range for over 50% of the time, with 10-15% of the time the patients were hypotensive (below the target range) and 30-40% of the time the patients were hypertensive (above the target range).

[0008] All patent publications herein are incorporated by reference to the same extent as if each individual patent publication or patent application was specifically and individually indicated to be incorporated by reference. To the extent that the definition or usage of a term in this specification differs from the definition or usage of the same term in an incorporated reference, the definition or usage of the term in this specification shall apply.

[0009] Accordingly, there remains a need for closed loop systems and methods to continually optimize the dosage rate of medication administered to a patient over time. SUMMARY

[0010] The subject matter of the present invention provides apparatuses, systems, and methods for regulating the flow of medication or other fluids to a patient. Information about the patient, such as one or more vital signs, can be received from at least one source including, for example, a transducer or other sensor. A target value and / or range for the one or more vital signs can be received. In one example, the target value and / or range can be input using a graphical user interface. An initial dosage rate of medication or other fluid to be administered to the patient can also be received.

[0011] Such vital signs can include, for example, the mean arterial pressure of the patient, but can also include any other vital sign that can be controlled, for example, by administering medication through intermittent infusion using an intravenous infusion apparatus.

[0012] Based on the received information about the patient, such as the one or more vital signs, a first control algorithm can be used to generate a revised dosage rate for delivery of the medication or other fluid to the patient. The first control algorithm determines a difference by comparing the value of the first vital sign to the target value, and then generates a revised dosage rate based on the initial (first) or current dosage rate and the difference. Once the medication is generated, the medication can be delivered to the patient according to the revised dosage rate. The first control algorithm can be configured to continually monitor the information of the patient (e.g., the one or more vital signs) and continually revise the dosage rate of the medication or other fluid as needed to keep the vital sign of the patient within a target range (i.e., a predetermined range from the target value of the vital sign).

[0013] In another embodiment, a non-transitory computer readable medium stores a computer program that includes commands that cause a processor to perform a method of adjusting a medication flowing to a patient. The program can receive information (i) a first vital sign of the patient from a first source and (ii) a target value for the first vital sign. An initial or current dose rate of the medication administered to the patient can also be received.

[0014] The processor can execute the computer program and compare a current value of the first vital sign to the target value or range to determine a difference, and then generate a revised dose rate for delivering the medication to the patient based on the initial (first) or current dose rate and the difference. Once the medication is generated, the medication can be delivered to the patient according to the revised dose rate.

[0015] The different objects, features, aspects and advantages of the present subject matter will become more apparent with reference to the drawings, from the detailed description, and by practising the present subject matter as disclosed and taught herein. BRIEF DESCRIPTION OF DRAWINGS

[0016] Figure 1 A prior art flowchart for manually adjusting a patient vital sign is shown.

[0017] Figure 2 A flowchart for automatically adjusting a patient vital sign is shown.

[0018] Figure 3 A diagram showing one embodiment of a method for adjusting a medication flow to a patient is shown.

[0019] Figure 4 An exemplary embodiment of a first control algorithm is shown.

[0020] Figure 5 An exemplary embodiment of a rules engine is shown.

[0021] Figure 6 An example of comparing target times of patients using manual control versus automatic control is shown.

[0022] Figure 7 One embodiment of a system for automatically adjusting a patient vital sign is shown. DETAILED DESCRIPTION

[0023] In the following discussion, numerous references can be made to servers, services, interfaces, portals, platforms, or other systems formed by computing devices. It should be understood that use of such terms is deemed to be equivalent to one or more computing devices having at least one processor configured to execute software instructions stored on a computer-readable tangible, non-transitory medium. For example, a server can include one or more computers operating as a web server, database server, or other type of computer server in a manner that fulfills the recited responsibilities, duties, or functions.

[0024] The following discussion provides many examples of implementing the inventive subject matter. Although each embodiment represents a single combination of the inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, and D, even if not explicitly stated.

[0025] Figure 2 A simplified flowchart is shown for automatically adjusting a patient's vital signs using automatic adjustment of a medication dosage rate to the patient based on changes in one or more vital signs of the patient.

[0026] Figure 3 A first embodiment of a method 100 for adjusting a flow of a medication 122 delivered to a patient 114 is shown. A first vital sign target value and an initial (first) or current dosage rate of the medication 122 to be administered to the patient 114 can be received, for example via an input to a graphical user interface 116.

[0027] Information 112 regarding a first vital sign of the patient 114 can be received from a first source 110, for example directly from a sensor, or indirectly, for example from a patient monitoring device. Based on the received information 112, a revised dosage rate 118 can be generated using a first control algorithm. The medication 122 can then be delivered to the patient 114 according to the revised dosage rate, for example using an infusion pump 120. In this manner, the first vital sign of the patient 114 can be monitored and the dosage rate of the medication 122 adjusted periodically and continuously according to the difference between the first vital sign and the target value or range, among other factors. In some embodiments, the adjustment to the dosage rate can take into account the initial (first) or current dosage rate, the difference between the current vital sign and the target value or range, and a scalar rate associated with the medication 122. While vasopressor medication is shown as the medication, it is contemplated that the systems and methods described herein can be used with any other medication that can be used to control one or more vital signs of a patient and that is intermittently infused to the patient.

[0028] In some contemplated embodiments, the processor runs a first control algorithm that compares a value of the first vital sign of the patient to a target value or range to determine a difference, and then generates a revised dose rate based on the initial (first) or current dose rate and the difference.

[0029] As one example, it is contemplated that the systems and methods herein can be used to regulate a patient's blood pressure, for example, by controlling the dose rate of a vaso-pressant drug that is intermittently administered to the patient. In such embodiments, it is contemplated that the first vital sign can comprise the mean arterial pressure (MAP) of the patient, which can be measured using a transducer attached to the patient. The system and method is preferably configured to monitor and track the MAP of the patient, and utilize a first control algorithm to generate a revised dose rate when the MAP of the patient changes, thereby maintaining the first vital sign of the patient within a target range of a target value (e.g., within 5 mmHg). For example, the revised dose rate can be communicated to an IV infusion device, which can then, for example, change the dose rate of the drug being administered to the patient.

[0030] It is further contemplated that additional safeguards can be used to help ensure that the systems and methods described herein do not conceal the fact that the patient's physical condition is continuing to deteriorate, for example, in a manner that maintains the patient's blood pressure or other vital sign by continuing to increase the dose rate of the drug. In one such example, it is contemplated that the initial (first) dose rate, a set of previous dose rates, the current dose rate (if applicable), and the revised dose rate can be stored in a memory communicatively coupled to the processor, and the processor can analyze the set of stored drug dose rates for the patient. If the rate of change of the drug dose rates exceeds a predetermined threshold over a set period of time, then the medical team can be notified that the patient can be deteriorating, even if the patient's vital sign is within the target range.

[0031] Additionally or alternatively, another safeguard that can be used is to require that a set period of time has elapsed between dose rate changes before making further adjustments to the dose rate of the drug. For example, it is contemplated that in the step of generating the revised dose rate, a first time period is determined that measures the time that has elapsed since the last change in the dose rate of the drug. Then, if the first time period is less than a minimum time period, then the dose rate is not changed. However, if the first time period is greater than or equal to the minimum time period, then the revised dose rate can be set to the initial (first) or current dose rate of the drug for the patient.

[0032] In such embodiments, the minimum time period is preferably greater than or equal to a line interval for the drug being delivered, which can be calculated by understanding the length of tubing through which the drug flows from the drug source to the patient and the flow rate of the drug through the tubing. General estimates are also possible. Importantly, the system and method will not change the dose rate until the patient has received the drug according to the existing dose rate. Since the line interval can be followed by one to two minutes or more, depending on the circumstances, this safeguard helps ensure that the system and method will not overcompensate by adjusting the drug dose rate without regard for the line interval, but rather allow time for the dose rate change to take effect.

[0033] To further ensure that the closed loop system and method are safe for the patient, minimum and maximum dose rates for the drug being delivered to the patient are preferably input. In the event that this does not occur, the system and method can be expected to either prompt the medical professional for the information or can have default values that can be used, which can be dependent on the drug being delivered to the patient.

[0034] In such embodiments, the first control algorithm can be expected to further determine whether the revised dose rate is greater than the minimum dose rate and less than the maximum dose rate. If not, the initial (first) or current dose rate can be expected to be maintained (not adjusted) and the drug can be delivered to the patient according to the initial (first) or current dose rate. In this case, it is further expected that an alarm state can be generated to alert the medical professional to the issue. Alternatively, the revised dose rate can be expected to be adjusted from the current dose rate to the minimum or maximum dose rate (if applicable) and an alarm state can be generated.

[0035] In still further embodiments, the system and method can be expected to further ensure that the change in dose rate at any one adjustment does not exceed a set amount (limit change threshold). For example, the first control algorithm can be expected to calculate the difference between the revised dose rate and the initial (first) current dose rate before the drug is delivered to the patient according to the revised dose rate. If the difference between the two dose rates exceeds the limit change threshold, the revised dose rate can be set to the limit change threshold plus the initial (first) or current dose rate. Thus, in such embodiments, while the dose rate will be changed, it will only be adjusted by the value of the limit change threshold. In such cases, it is further expected that an alarm state can be generated to alert the medical professional to the issue.

[0036] It is further contemplated that, in addition to the first source, a second source can independently monitor the first vital sign. Information about the first vital sign can be received from the second source and the information received from the second source can be compared to the information received from the first source about the first vital sign. If the difference between the information of the first and second sources exceeds a predetermined threshold, an alert command can be generated. It is contemplated that the information received from one of these sources can be converted in order to compare these values, regardless of whether the units of the measured vital signs differ between the information measured by the first and second sources. For example, for blood pressure monitoring, it is contemplated that the first source can monitor the MAP of the patient while the second source can monitor the systolic (SBP) and diastolic (DBP) blood pressures of the patient. In this case, the systolic pressure can be converted to MAP using the following formula:

[0037]

[0038] In addition to the first vital sign that can be monitored, it is contemplated that other vital signs of the patient can be monitored, including, for example, oxygen saturation level (Sp02), body temperature, and electrical signals from the heart (EKG). Additionally or alternatively, perfusion and / or metabolic activity of the patient can also be monitored.

[0039] As just one example, in monitoring the blood pressure of a patient, it is contemplated that the first source can be a transducer attached to the patient and the second source can be a blood pressure monitor configured to monitor the systolic pressure.

[0040] In another aspect, a non-transitory computer readable medium having a computer program stored thereon is provided. Preferably, the computer program includes commands that cause a processor of a server to execute a method for regulating the flow of a medication to a patient. Thus, for example, an intravenous infusion device can include a processor communicatively coupled with a non-transitory computer readable medium storing a computer program that can include or incorporate the first control algorithm discussed above. The intravenous infusion device can be a control unit that monitors and calculates the dosage rate, or a separate control unit can communicate with the intravenous infusion device to control the dosage rate of the medication administered to the patient.

[0041] The computer program can be configured to receive information about a first vital sign of a patient from a first source via a control unit. A target value for the first vital sign and an initial (first) or current dosage rate of a medication to be or being administered to the patient can also be received, for example, via a GUI connected with the control unit.

[0042] Based on the received information, the processor of the control unit can execute a computer program and compare the value of the first vital sign to a target value or range to determine a difference. A revised dose rate can then be generated based on the initial (first) or current dose rate and the difference and communicated to the infusion device to deliver the medication to the patient at the revised dose rate, and the current dose rate can be adjusted to the revised dose rate.

[0043] The medication can then be delivered to the patient using the infusion device according to the revised dose rate.

[0044] In some embodiments, the first vital sign can include mean arterial pressure of the patient, and the medication can include a vasopressor. In such embodiments, the first source can be a transducer attached to the patient or another sensor capable of measuring MAP or other indicators of blood pressure of the patient.

[0045] The first, previous, current (if applicable), and revised dose rates can be stored in the same or different non-transitory computer-readable media. A set of stored medication dose rates can be analyzed, and an alert command can be generated if the rate of change of the dose rate exceeds a predetermined threshold over a particular time period.

[0046] As noted above, various other safeguards can be implemented in the computer program to ensure that adjustments to the dose rate are safe for the patient. Examples include setting minimum and maximum dose rates for the medication, limiting the frequency with which the dose rate can be adjusted, and / or setting a maximum value for a single adjustment to the dose rate.

[0047] Thus, for example, it is contemplated that generating the revised dose rate includes first determining whether at least a preset amount of time or minimum time period has passed since the last change in dose rate, and if not, the dose rate can remain unchanged. If the amount of time that has passed exceeds the minimum time period, the dose rate can be adjusted. Preferably, in such embodiments, the minimum time period can be greater than or equal to the line spacing permitted to exist for the medication being administered to the patient. As noted above, this line spacing is based on the length of tubing measured between the source of the medication and the patient and the flow rate of the medication through the tubing.

[0048] It is also contemplated that generating the revised dose rate can include calculating a difference between the revised dose rate and the initial (first) or current dose rate. If the difference between the current dose rate and the revised dose rate exceeds a limit change threshold, the revised dose rate can be set to the limit change threshold plus the initial (first) or current dose rate.

[0049] Various systems for adjusting the flow of medication to a patient are also contemplated. In Figure 7In particular embodiments, one embodiment of system 200 can include a control unit 220 having a processor 222 communicatively coupled with a memory 224 configured to store a first control algorithm. Control unit 220 is configured to receive information about a first vital sign of patient 240, a target value or range for the first vital sign, and an initial (first) or current dosage rate for intermittently delivering a medication to the patient from a first source. The medication can be delivered using an infusion device that can or can not include control unit 220.

[0050] If the vital sign is outside the target range, control unit 220 generates a revised dosage rate for delivering the medication to patient 240 using the first control algorithm. The first control algorithm is programmed to compare the value of the first vital sign to the target value or range to determine a difference, and then generate the revised dosage rate based on the initial (first) or current dosage rate and the difference. For example, if the vital sign of the patient exceeds the target value or range, a difference between the vital sign and the target value or range can be calculated. Control unit can then calculate an additional amount of medication (an increase to the dosage rate) needed to lower the vital sign into the target range. This increase to the dosage rate can then be added to the current dosage rate to generate the revised dosage rate.

[0051] Control unit 220 can then send a command signal to cause the medication to be delivered to patient 240 via infusion pump 230 at the revised dosage rate.

[0052] In some contemplated embodiments, the first vital sign includes mean arterial pressure of patient 240 and the first source includes a transducer attached to patient 240.

[0053] It is also contemplated that control unit 220 can store a history of initial dosage rates and adjustments to the dosage rate or revised dosage rate, and analyze the stored medication dosage rates for patient 240. Control unit 220 can generate an alarm command when the rate of change of the dosage rate over a period of time exceeds a predetermined threshold.

[0054] As mentioned above, various other safety measures can be implemented in the control algorithm of control unit 220 to ensure that the dosage rate is safe for patient 240. Examples include setting minimum and maximum dosage rates, limiting the frequency of adjusting the dosage rate, and / or setting a maximum value for the dosage rate adjustment.

[0055] Example implementations of computer software or the first control algorithm include Figure 4A PID controller can be used to determine the dose rate change based on the target value for the vital sign, the current value for the vital sign, and optionally the patient's blood pressure history. The resulting value can be multiplied by the drug scalar to obtain a dose rate change value, which can then be combined with the current dose rate to generate a revised dose rate. The revised dose rate can be analyzed by the rules engine to ensure that the new dose rate is safe for the patient, for example by implementing some or all of the above-mentioned safeguards to ensure such safety.

[0056] An example rules engine is shown in FIG. 7. Figure 5 As shown, the revised dose rate calculated using the control algorithm can be analyzed to ensure that it is safe for the patient. Although shown in a particular order, it is contemplated that the order of the analysis can be changed without departing from the scope of the invention.

[0057] As shown, the time elapsed since the last dose rate change for the drug can be monitored. When the revised dose rate is calculated, the time elapsed can be compared to a first threshold. If the time elapsed is less than the first threshold, then the dose rate will not be adjusted (no change). If the time elapsed is greater than or equal to the first threshold, then the dose rate will be adjusted if all other programmed criteria are met.

[0058] The adjustment to the dose rate can also be analyzed to ensure that the adjustment is greater than a minimum value and less than a maximum value. This helps to ensure that no adjustment is made unless a minimum amount is exceeded, for example the minimum change allowed by the infusion device. It also ensures that any adjustment to the dose rate is gradual, rather than occurring in large changes over a short period of time. If the adjustment is between the two values, then the dose rate will be adjusted if all other programmed criteria are met. If not, then the dose rate will not be adjusted (no change).

[0059] The revised dose rate can also be compared to minimum and maximum dose rate values to ensure that the revised dose rate is not outside of these thresholds. If the revised dose rate is between the two values, then the dose rate will be adjusted if all other programmed criteria are met. If not, then the dose rate will not be adjusted (no change).

[0060] Figure 6 A comparison of manual control of patient blood pressure to automatic control using the closed loop system and method described herein is shown in FIG. 8. As shown, the automatic control target time (95%) far exceeds the manual control target times (46% and 59%). The target time is calculated by determining how long the patient's blood pressure is within ±5 mmHg of the target value set by the patient for a specified period of time.

[0061] The use of the closed-loop system and method described herein also resulted in a 40% lower total dose of vasopressor in those patients using the closed-loop system and method than in those patients using manual control (control group). In addition, the closed-loop system adjusted the rate of vasopressor dose to over 1,000 per patient, compared to an average of 15 per patient in the control group.

[0062] During surgery, the percentage of patients using the closed-loop system and method who experienced hypotension (defined as MAP < 90% of patient baseline MAP) was 1.2%, while the percentage of those patients using manual control who experienced hypotension was 21.5%. During surgery, the percentage of patients using the closed-loop system who experienced MAP < 65 mmHg was also lower than the percentage of patients in the control group (average 0% vs 1.9%). The percentage of time that patients using the closed-loop system and method were in the target MAP range (± 10 mmHg of baseline MAP value) was 97.2% on average, while the percentage of time that patients using manual control were in the target MAP range was 58.8% on average. The percentage of time that patients using the closed-loop system and method were hypertensive (defined as MAP > 10 mmHg of MAP target) was also lower than the percentage of time that patients in the control group using manual control were hypertensive (average 2.5% vs 12.9%).

[0063] As used herein, and unless the context clearly indicates otherwise, the term "coupled to" is intended to include both direct coupling (in which two elements that are coupled to each other contact each other) and indirect coupling (in which at least one additional element is located between the two elements). Therefore, the terms "coupled to" and "coupled with" are used synonymously.

[0064] In some embodiments, numbers expressing quantities of ingredients, such as concentrations, reaction conditions, and other numerically- expressed items, in the written description and claims should be understood as being modified in some instances by the term "about." Accordingly, in some embodiments, numerical parameters are approximations and can vary depending upon the desired properties sought to be obtained by the particular embodiments. In some embodiments, numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the application are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the present application can contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0065] All ranges recited herein are inclusive of the recited endpoints and open-ended ranges are inclusive of the excluded endpoints. Similarly, all lists recited herein are inclusive of all members individually and also inclusive of other non-specified members and ranges.

[0066] As used in the description of the application and the appended claims, the meanings of "a", "an", and "the" include plural references. In addition, as used in the description of the application, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.

[0067] The recitation of numerical ranges by endpoints herein is merely intended to serve as a shorthand method of referring individually to each integer falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein. The use of any and all examples, or exemplary language (e.g., "such as") provided herein, is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[0068] Groupings of alternative elements or embodiments of the application disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other alternative elements or embodiments found in the disclosure. One or more group members can be included in, or deleted from, a group for reasons of convenience and / or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the proper language by which the claimer intended to encompass that variation.

[0069] It will be obvious to a person skilled in the art that, in addition to the modifications already described, many modifications can be made to the application as described herein without, however, departing from the inventive concept thereof. Consequently, the subject matter of the application is not limited to the spirit of the attached claims only, but is otherwise not restricted. Furthermore, all terms are to be interpreted in the broadest possible way in accordance with the context in which they are used in the specification and claims. In particular, the terms "comprising", "comprise" and "comprised of" should be interpreted as referring to elements, components or steps in a non-exclusive manner, indicating that not all of them are necessarily present or involved in the process or method described or claimed. In the description and claims of the application, relative terms such as "first", "second", "third", etc. are used to distinguish one element from another. However, the application is not limited to these exact terms. It should be understood that when an element is referred to as being "connected to" or "coupled to" another element, it can be directly connected or coupled to the other element or intervening elements can be present. In contrast, when an element is referred to as being "directly connected to" or "directly coupled to" another element, there are no intervening elements present. In the description and claims of the application, all transitional phrases such as "comprising", "including", "carrying", "having", "containing", "involving", "holding", "composed of", and the like are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of and "consisting essentially of" are to be construed as being closed or semi-closed transitional phrases, respectively, meaning that the application includes only the elements that are recited in the claim or, in the case of a "consisting essentially of" claim, that the application includes the elements as set forth in the claim in addition to any other non-essential elements.

Claims

1. A non-transitory computer-readable medium storing a computer program, characterized in that, The computer program includes commands that cause the server's processor to execute a method for regulating the flow of medication to a patient, including: The control unit receives information representing the current value of the patient's primary vital signs from a first source. The target value of the first vital sign is received through the control unit; The control unit receives and stores the first dose rate of the drug delivered to the patient. The control unit compares the current value of the first vital sign with the target value to determine the difference; The control unit uses a computer program to generate a corrected dose rate for delivering the drug to the patient based on the first dose rate and the dose adjustment amount; The corrected dose rate is stored in the non-transitory computer-readable medium; Analyze the set of dose rates of the drug for the patient, including the first dose rate; If the rate of change of the dose rate exceeds a predetermined threshold within a set time period, an alarm command is generated; Before delivering the drug to the patient according to the revised dose rate, it is determined whether a first time period exceeds a minimum time period, wherein the first time period is defined as the elapsed time since the last dose rate change occurred. If the first time period is less than the minimum time period, then the corrected dose rate is set to the first dose rate; If the first time period is longer than the minimum time period, the drug is delivered to the patient according to the corrected dose rate; and Wherein, the minimum time period is greater than or equal to the pipeline delay time; and The drug is delivered to the patient according to the modified dose rate.

2. The non-transitory computer-readable medium according to claim 1, characterized in that, The first vital sign includes the patient’s mean arterial pressure, and the first source includes a transducer connected to the patient.

3. The non-transitory computer-readable medium according to claim 1, characterized in that, The method further includes: Receive a minimum dose rate and store the minimum dose rate in the non-transitory computer-readable medium; receive a maximum dose rate and store the maximum dose rate in the non-transitory computer-readable medium; and Determine whether the corrected dose rate is greater than the minimum dose rate and less than the maximum dose rate; and If not, then (i) the modified dose rate is set to the first dose rate, (ii) the drug is delivered to the patient according to the first dose rate, and (iii) an alarm command is generated.

4. The non-transitory computer-readable medium according to claim 1, characterized in that, The method further includes: Before delivering the drug to the patient according to the corrected dose rate, the difference between the corrected dose rate and the first dose rate is calculated; and If the difference exceeds the limit threshold, the corrected dose rate is set to the limit threshold plus the first dose rate.

5. The non-transitory computer-readable medium according to claim 1, characterized in that, The method further includes: Information about the first vital signs is received from a second source, the second source including a blood pressure monitor configured to monitor the patient's systolic blood pressure; Compare the information received from the first source and the second source regarding the first vital sign; If the difference between the first vital sign measured from the first source and the second source exceeds a predetermined threshold, an alarm command is generated.

6. The non-transitory computer-readable medium according to claim 1, characterized in that, The medication includes a vasopressor, the first vital sign includes the patient’s mean arterial pressure, and a first control algorithm is configured to generate the modified dose rate to keep the first vital sign within 5 mmHg of the target value.

7. The non-transitory computer-readable medium according to claim 1, characterized in that, The method further includes: The flow rate of the receiving carrier fluid; The pipeline delay time is calculated based on the flow rate of the carrier fluid. Set the minimum time period to be equal to the pipeline delay time; and The step of generating the corrected dose rate further includes first determining whether a first time period exceeds the minimum time period, wherein the first time period is the time elapsed since the last dose rate change.

8. A system for regulating the flow rate of a drug delivered to a patient, comprising: A control unit includes a processor and a memory communicatively connected to the processor, wherein the memory stores a first control algorithm; The control unit is configured to receive information from a first source regarding the current value of the patient's first vital signs; The control unit is also configured to receive a target value or range of the first vital sign and a first dose rate for delivering the drug to the patient. The control unit uses a first control algorithm to generate a corrected dose rate for delivering the drug to the patient. Before delivering the drug to the patient according to the revised dose rate, it is determined whether a first time period exceeds a minimum time period, wherein the first time period is defined as the elapsed time since the last dose rate change occurred. If the first time period is less than the minimum time period, then the corrected dose rate is set to the first dose rate; If the first time period is longer than the minimum time period, the drug is delivered to the patient according to the corrected dose rate; and Wherein, the minimum time period is greater than or equal to the pipeline delay time; The control unit sends a command signal to deliver the drug to the patient at the corrected dose rate; The first control algorithm includes the following steps: The current value of the first vital sign is compared with the target value or range to determine the difference; a dose adjustment is calculated based on the difference and the drug scaling value; and The corrected dose rate is generated as a function of the dose adjustment amount and the first dose rate; and The control unit is further configured as follows: Store the first dose rate and the corrected dose rate; Analyze the dose rate set of the drug for the patients; and If the rate of change of the dose rate exceeds a predetermined threshold within a set time period, an alarm command is generated.

9. The system according to claim 8, characterized in that, The first vital sign includes the patient’s mean arterial pressure, and the first source includes a transducer connected to the patient.

10. The system according to claim 8, characterized in that, The control unit is also configured to: Receive minimum and maximum dose rates; Determine whether the corrected dose rate is greater than the minimum dose rate and less than the maximum dose rate; as well as If not, (i) set the corrected dose rate to the first dose rate, (ii) maintain the first dose rate and deliver the drug to the patient, and (iii) generate an alarm command.

11. The system according to claim 8, characterized in that, The control unit is also configured to: Before delivering the drug to the patient according to the corrected dose rate, the difference between the corrected dose rate and the first dose rate is calculated; as well as If the difference exceeds the limit threshold, the corrected dose rate is set to the limit threshold plus the first dose rate.

12. The system according to claim 8, characterized in that, The control unit is also configured to: Information about the first vital signs is received from a second source, the second source including a blood pressure monitor configured to monitor the patient's systolic blood pressure; Compare the information received from the first source and the second source regarding the first vital sign; If the difference between the first vital sign measured from the first source and the second source exceeds a predetermined threshold, an alarm command is generated.

13. The system according to claim 8, characterized in that, The medication includes a vasopressor, the first vital sign includes the patient’s mean arterial pressure, and the first control algorithm is configured to generate the modified dose rate to keep the first vital sign within 5 mmHg of the target value.

14. The system according to claim 8, characterized in that, The control unit is also configured to: The flow rate of the receiving carrier fluid; The pipeline delay time is calculated based on the flow rate of the carrier fluid. Set the minimum time period to be equal to the pipeline delay time; and The step of generating the corrected dose rate further includes first determining whether a first time period exceeds the minimum time period, wherein the first time period is the time elapsed since the last dose rate change.

15. The system according to claim 8, characterized in that, The control unit is also configured to: Before generating the corrected dose rate, the information about the first vital sign is compared with stored vital signs, which represent the vital signs prior to receiving the first vital sign. as well as If the first vital sign is equal to the stored vital sign, then the corrected dose rate is set to the first dose rate.

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