WO2022095993A1

WO2022095993A1 - Infusion control method and device, infusion system, and pump body device

Info

Publication number: WO2022095993A1
Application number: PCT/CN2021/129254
Authority: WO
Inventors: 吕剑峰
Original assignee: 微泰医疗器械(杭州)股份有限公司
Priority date: 2020-11-09
Filing date: 2021-11-08
Publication date: 2022-05-12
Also published as: CN112472913A

Abstract

Disclosed are an infusion control method and device, an infusion system, and a pump body device, facilitating improving the safety and reliability of the infusion process. The infusion system comprises a controller and a pump body used for infusion. The controller is configured to control the pump body to perform infusion, obtain an infusion historical record stored in the pump body, determine, according to the latest historical record stored in the pump body, whether the pump body is performing infusion, and output prompt information according to a determination result; and the pump body is configured to perform infusion and store infusion historical records of the pump body.

Description

Infusion control method and device and infusion system and pump device

technical field

The present invention relates to the technical field of machinery, and in particular, to an infusion control method and device, as well as an infusion system and a pump body device.

Background technique

Insulin pump is an insulin infusion system that simulates the secretion of insulin by the human pancreas. It can control the blood sugar level of diabetic patients and reduce blood sugar fluctuations through continuous and micro-infusion of insulin into the human body. The traditional insulin pump mostly adopts the integrated design of the medicine reservoir, the injection mechanism and the control display panel. The user inputs various insulin pump operating parameters such as the basal rate plan and the large-dose injection volume through the control panel buttons on the pump body, and controls the insulin. Various states such as start and stop of the pump. It is usually necessary to set up regular and quantitative routine infusions to ensure the basic control of blood sugar levels; in addition, in special circumstances, for example, before a large amount of food is required in some occasions, the injection volume can be additionally increased. To meet the current special needs for insulin. When performing a bolus infusion, the user is required to manually operate the controller to send infusion instructions to the pump.

As a portable medical device that requires 24 hours of long-term work, insulin pumps have been developing in the direction of miniaturization and portability. Since the integrated structure is not conducive to the reduction of the size of the device, new products with the injection mechanism and the controller separated have appeared in recent years. form. Fig. 1 is a schematic diagram of the basic components of an infusion system related to the present invention. As shown in Fig. 1, the infusion system mainly includes a pump body and a controller, wherein the pump body is fixed on the human body and is connected with the controller (Fig. Take the handheld controller as an example) to communicate.

As the injection execution unit, the insulin pump body has no control and display panel and other components, and the volume can be made very small, and can even be directly attached to the injection site of the human body; while the portable handheld controller is responsible for inputting control commands, monitoring the operation of the pump body, etc. function and interact with the pump body through short-range wireless communication such as Bluetooth. Since there is no size limit, the controller can be developed based on the latest mobile intelligent terminal platform, similar in appearance to a mobile phone, and equipped with modern human-computer interaction interfaces such as a large-size color touch screen, which greatly improves the user experience and the degree of device intelligence.

The product design that controls the insulin pump wirelessly increases the user's convenience, but also creates some new problems. Since short-range wireless communication technologies such as bluetooth and wifi usually have the limitation of communication distance and the communication quality is easily affected by the environment, users will inevitably encounter abnormal situations such as poor communication connection or failure during daily use, which may lead to Overinfusion, as shown in FIG. 2, which is a schematic diagram of a flow of overdose caused by a communication failure.

Therefore, when designing the wireless communication protocol between the controller and the pump, the fault tolerance and failure recovery mechanism in the case of abnormal communication should be fully considered, and the insulin infusion process should be guaranteed to the greatest extent by means of communication data verification, confirmation, failure detection, and retransmission. security and reliability.

However, different from other control commands such as the basal rate setting, the special operation of large-dose infusion has the characteristics of superposition of multiple commands. Only relying on the fault tolerance and failure recovery mechanism of communication, the safety and reliability of the infusion process There is still room for improvement.

SUMMARY OF THE INVENTION

In view of this, the present invention provides an infusion control method and device, as well as an infusion system and a pump body device, which help to improve the safety and reliability of the infusion process.

The present invention provides the following technical solutions:

An infusion system, comprising a controller and a pump body for infusion, wherein: the controller is used to control the pump body for infusion, and obtain the infusion history record saved by the pump body, and according to the latest history saved by the pump body Record and judge whether the pump body is infusion, and output prompt information according to the judgment result; the pump body is used for infusion and save the infusion history record of the pump body.

Optionally, in the case that the judgment result is yes, the prompt information includes the current infusion progress.

Optionally, the controller is further configured to terminate the current process when the communication with the pump body times out.

Optionally, in the case that the judgment result is no, the controller is further configured to acquire the last infusion history record saved by the pump body and present it on the man-machine interface, so that the user can confirm whether to send an infusion instruction.

Optionally, in the case that the judgment result is no, the controller is also used to synchronize the locally saved infusion history record and the infusion history record saved by the pump body, and synchronize the latest local last time after synchronization. The infusion history is presented on the human-machine interface for the user to confirm whether the controller is required to send an infusion instruction to the pump.

Optionally, the pump body is an insulin pump.

An infusion control method, comprising: step 1: a controller receives an infusion operation instruction initiated by a user through a man-machine interface; step 2: the controller queries the latest infusion history record cached by a pump body; step 3: the controller according to The last infusion history record determines whether the pump body is undergoing infusion, if so, go to step 10, otherwise go to step 4; step 4: the controller obtains the latest infusion history record saved locally; step 5: the controller compares Whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, go to step 7, otherwise go to step 6; Step 6: The controller obtains the infusion cached by the pump body from the pump body History record and save to the local; Step 7: The controller presents the information of the last infusion saved locally through the man-machine interface, for the user to confirm whether the controller needs to send the infusion instruction to the pump body; Step 8: The controller according to the user If the user confirms the result is yes, go to step 9, otherwise end the process; step 9: the controller sends an infusion instruction to the pump body; step 10: the controller presents the current infusion progress through the human-machine interface.

An infusion control device, comprising: a first module, used for receiving an infusion operation instruction initiated by a user through a man-machine interface; a second module, used for querying the latest infusion history record cached by a pump body; and a third module, for judging whether the pump body is undergoing infusion according to the last infusion history record, if so, trigger the tenth module, otherwise trigger the fourth module; the fourth module is used to obtain the latest infusion history record saved locally; The fifth module is used to compare whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, trigger the seventh module, otherwise trigger the sixth module; the sixth module, used for Obtain the infusion history record buffered by the pump body from the pump body and save it locally; the seventh module is used to present the information of the latest infusion saved locally through the human-machine interface, so that the user can confirm whether the controller needs to send the pump body to the pump body. Infusion instruction; the eighth module is used to judge according to the user's confirmation result, if the user's confirmation result is yes, then the ninth module is triggered, otherwise the process ends; the ninth module is used to send the infusion instruction to the pump body; Ten modules are used to present the current infusion progress through the human-machine interface.

Optionally, the infusion control device is provided in the controller of the insulin pump.

A pump body device is arranged in the pump body, comprising: a recording module for recording the progress of this infusion after the infusion starts; a sending module for sending the latest infusion history record buffered by the pump body to a controller , and all infusion history records of the pump buffer are sent to the controller; the receiving module is used to receive the infusion instructions sent by the controller.

Optionally, the pump body is an insulin pump.

According to the technical solution of the embodiment of the present invention, the pump body records the infusion facts and is acquired by the controller, which is then presented to the user, so that the user can know whether the infusion has been actually performed recently and decide whether to perform the infusion. When the user grasps the real situation of the infusion, the occurrence of overinfusion can be avoided more effectively.

Description of drawings

For purposes of illustration and not limitation, the present invention will now be described in accordance with preferred embodiments thereof, particularly with reference to the accompanying drawings, wherein:

Figure 1 is a schematic diagram of the essential components of an infusion system relevant to the present invention;

Fig. 2 is a schematic diagram of a process of over-infusion caused by communication failure;

3 is a schematic diagram of an infusion control method according to an embodiment of the present invention.

Detailed ways

In the embodiment of the present invention, taking the processing of large-dose insulin infusion as an example, when the user initiates large-dose insulin infusion, the controller determines whether the pump is infusion according to the latest historical record saved by the pump, and controls The man-machine interface of the device presents prompt information. Specifically, if an infusion is in progress, the current infusion progress is displayed, otherwise, text such as "currently no bolus infusion" or other text is displayed. Each history record contains bolus infusion status information that can be used to determine whether an infusion is in progress. This status information can be represented by the bolus infusion rate, when the rate is greater than zero, it indicates that a bolus infusion is in progress, and a rate of zero indicates that there is currently no infusion. At the start time and end time of high-dose infusion (marked by the start and stop of the insulin pump administration mechanism), the pump will generate a history record. In the history of the moment, the bolus rate is equal to zero. The bolus infusion rate is determined by the structure of the product. Therefore, if the bolus rate of the last history of the pump is not zero, it means that the bolus infusion is still in progress. Compared with the method of directly detecting the liquid flow, this method of judging according to the speed is easier to realize. In addition, the infusion volume of this bolus can be calculated according to the historical records of the infusion start and end: infusion volume = initial bolus infusion rate × (end time - start time). According to this, the infusion volume and time of the last large dose can be obtained for the user to confirm.

If the bolus infusion is not currently performed, the time of the last bolus infusion is presented to the user on the man-machine interface, so that the user can decide whether to perform the bolus infusion at this time. In an embodiment of the present invention, the pump can keep a historical record of its infusion, so the controller can obtain this record from the pump and provide it to the user.

Because the controller can be equipped with a larger memory than the pump body to save more history for the user to view or perform data analysis, the controller can also save the above history locally, and present the most recent high dose. During infusion, the controller first obtains the locally saved historical records. Considering that the abnormal communication may cause the historical records not to be completely transmitted to the controller, the controller compares the local recent historical records with the most recent historical records obtained from the pump body. Compare and take the one saved by the pump body as the criterion, that is, synchronize the content saved by the controller to the content saved by the pump body if the two are inconsistent.

In addition, in the above processing process, if the communication times out, the process ends, and the user is prompted to use the controller to re-initiate the large-dose infusion operation. The above process is shown in FIG. 3 , which is a schematic diagram of an infusion control method according to an embodiment of the present invention, including the following steps 1 to 10 .

Step 1: the controller receives the infusion operation instruction initiated by the user through the man-machine interface;

Step 2: The controller queries the latest infusion history record cached by the pump body;

Step 3: The controller determines whether the pump body is infusion according to the last infusion history record, if so, it goes to step 10, otherwise it goes to step 4;

Step 4: The controller obtains the last infusion history record saved locally;

Step 5: The controller compares whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, go to step 7, otherwise go to step 6;

Step 6: The controller performs record synchronization, obtains the infusion history record buffered by the pump body from the pump body and saves it locally;

Step 7: The controller presents the latest infusion history record saved locally through the man-machine interface, so that the user can confirm whether the controller is required to send an infusion instruction to the pump body;

Step 8: The controller judges whether to send an infusion instruction according to the user's confirmation result, if the user's confirmation result is yes, then go to Step 9, otherwise end the process;

Step 9: The controller sends an infusion instruction to the pump body;

Step 10: The controller presents the current infusion progress through the man-machine interface.

In order to simplify the description, the steps of timeout processing are omitted in the above listed steps. In the implementation, the timeout judgment as shown in the figure can be added to the relevant steps, and the process is directly ended when the communication between the controller and the pump is overtime. , and can present prompt information to the user.

The infusion control device software is set in the controller to realize the above control method, which may include the following functional modules:

The first module is used for receiving the infusion operation instruction initiated by the user through the man-machine interface;

The second module is used to query the latest infusion history record of the pump cache;

The third module is used for judging whether the pump body is undergoing infusion according to the last infusion history record, if so, triggering the tenth module, otherwise triggering the fourth module;

The fourth module is used to obtain the latest infusion history record saved locally;

The fifth module is used to compare whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, trigger the seventh module, otherwise trigger the sixth module;

The sixth module is used to obtain the infusion history record buffered by the pump body from the pump body and save it locally;

The seventh module is used to present the information of the last infusion saved locally through the man-machine interface, so that the user can confirm whether the controller is required to send an infusion instruction to the pump body;

The eighth module is used to judge according to the user's confirmation result, if the user's confirmation result is yes, then trigger the ninth module, otherwise end the process;

The ninth module is used to send an infusion instruction to the pump body;

The tenth module is used to present the current infusion progress through the man-machine interface.

Generally speaking, the above control methods can be set in various types of infusion controllers to control the pump body that performs the infusion operation, for example, in the controller of an insulin pump. In addition, a timeout processing module can also be set in the software to terminate the current process when the communication between the controller and the pump body times out, and can also issue a prompt to the user. Correspondingly, a pump body device as software can also be provided in the pump body, including a recording module, a sending module and a receiving module, wherein the recording module is used to record the progress of this infusion after the start of the infusion; The controller sends the last infusion history record buffered by the pump body, and is used to send all the infusion history records buffered by the pump body to the controller; the receiving module is used to receive the infusion instruction sent by the controller. The recording module here records after the start of the infusion to confirm that the record matches the fact that the infusion occurred.

In the prior art, a special high-dose infusion control and confirmation process is used to ensure that safety risks such as wrong infusion or over-infusion will not occur. For example, when the user initiates a large-dose injection command through the controller, the pump body is After receiving this command, it will start to inject a large dose, and the pump body needs to return the confirmation information of the command to the controller, so that the controller knows that the command has been successfully received. If the confirmation information is not received by the controller due to wireless communication interference and other reasons at this time, the controller will consider the command sending failed and display the relevant prompt information. The user mistakenly believes that the large-dose infusion of the pump has not started, and it is very likely that the large-dose infusion command will be issued again through the controller. If the new large-dose command is also received by the pump and starts to inject, the two superimposed large-dose will Causes an overdose of insulin, potentially putting the user at risk of hypoglycemia. According to the technical solution of the embodiment of the present invention, the pump body records the infusion facts and acquires them by the controller, which is then presented to the user, so that the user can know whether the infusion has been actually performed recently and decide whether to perform the infusion. When the user grasps the real situation of the infusion, the occurrence of overinfusion can be avoided more effectively.

The above-mentioned specific embodiments do not constitute a limitation on the protection scope of the present invention. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may occur depending on design requirements and other factors. Any modifications, equivalent replacements and improvements made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

An infusion system, comprising a controller and a pump body for infusion, wherein:

The controller is used to control the pump body for infusion, obtain the infusion history record saved by the pump body, and judge whether the pump body is infusion according to the latest history record saved by the pump body, and output prompt information according to the judgment result;

The pump is used to make infusions and save the pump's infusion history.
The infusion system according to claim 1, wherein in the case that the judgment result is yes, the prompt information includes the current infusion progress.
The infusion system of claim 1, wherein the controller is further configured to terminate the current process if communication with the pump times out.
The infusion system according to claim 1, 2 or 3, characterized in that, in the case that the judgment result is no, the controller is further configured to acquire the latest infusion history record saved by the pump body and present it On the human-machine interface, for the user to confirm whether to send the infusion instruction.
The infusion system according to claim 1, 2 or 3, characterized in that, in the case that the judgment result is no, the controller is further configured to store the locally saved infusion history record and the pump body saved infusion history record. The infusion history record is synchronized, and the local latest infusion history record after synchronization is presented on the man-machine interface, so that the user can confirm whether the controller needs to send an infusion instruction to the pump body.
The infusion system according to claim 1, 2 or 3, wherein the pump body is an insulin pump.
An infusion control method, comprising:

Step 1: the controller receives the infusion operation instruction initiated by the user through the man-machine interface;

Step 2: The controller queries the latest infusion history record cached by the pump body;

Step 3: The controller determines whether the pump body is infusion according to the last infusion history record, if so, it goes to step 10, otherwise it goes to step 4;

Step 4: The controller obtains the last infusion history record saved locally;

Step 5: The controller compares whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, go to step 7, otherwise go to step 6;

Step 6: The controller obtains the infusion history record buffered by the pump body from the pump body and saves it locally;

Step 7: The controller presents the information of the last infusion saved locally through the human-machine interface, so that the user can confirm whether the controller is required to send an infusion instruction to the pump body;

Step 8: The controller judges according to the user's confirmation result, if the user's confirmation result is yes, then enters Step 9, otherwise ends the process;

Step 9: The controller sends an infusion instruction to the pump body;

Step 10: The controller presents the current infusion progress through the man-machine interface.
An infusion control device, characterized in that it comprises:

The first module is used for receiving the infusion operation instruction initiated by the user through the man-machine interface;

The second module is used to query the latest infusion history record of the pump cache;

The third module is used for judging whether the pump body is undergoing infusion according to the last infusion history record, if so, triggering the tenth module, otherwise triggering the fourth module;

The fourth module is used to obtain the latest infusion history record saved locally;

The fifth module is used to compare whether the last infusion history record saved locally is consistent with the last infusion history record cached by the pump body, if so, trigger the seventh module, otherwise trigger the sixth module;

The sixth module is used to obtain the infusion history record buffered by the pump body from the pump body and save it locally;

The seventh module is used to present the information of the last infusion saved locally through the man-machine interface, so that the user can confirm whether the controller is required to send an infusion instruction to the pump body;

The eighth module is used to judge according to the user's confirmation result, if the user's confirmation result is yes, then trigger the ninth module, otherwise end the process;

The ninth module is used to send an infusion instruction to the pump body;

The tenth module is used to present the current infusion progress through the man-machine interface.
The infusion control device according to claim 8, characterized in that it is provided in the controller of the insulin pump.
A pump body device, arranged in the pump body, is characterized in that, comprising:

The recording module is used to record the progress of the infusion after the infusion starts;

The sending module is used to send the last infusion history record of the pump body buffer to the controller, and is used to send all the infusion history records of the pump body buffer to the controller;

The receiving module is used for receiving the infusion instruction sent by the controller.
The pump body device according to claim 10, wherein the pump body is an insulin pump.