CN112472913A - Infusion control method and device, infusion system and pump body device - Google Patents

Infusion control method and device, infusion system and pump body device Download PDF

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Publication number
CN112472913A
CN112472913A CN202011240128.7A CN202011240128A CN112472913A CN 112472913 A CN112472913 A CN 112472913A CN 202011240128 A CN202011240128 A CN 202011240128A CN 112472913 A CN112472913 A CN 112472913A
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infusion
pump body
controller
module
history
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Chinese (zh)
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吕剑峰
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Micro Tech Medical Hangzhou Co ltd
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Micro Tech Medical Hangzhou Co ltd
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Priority to CN202011240128.7A priority Critical patent/CN112472913A/en
Publication of CN112472913A publication Critical patent/CN112472913A/en
Priority to PCT/CN2021/129254 priority patent/WO2022095993A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M2005/14208Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow
    • A61M2205/3334Measuring or controlling the flow rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention discloses an infusion control method and device, an infusion system and a pump body device, which are beneficial to improving the safety and reliability of an infusion process. The infusion system includes a controller and a pump body for infusion, wherein: the controller is used for controlling the pump body to carry out infusion, acquiring an infusion history record stored in the pump body, judging whether the pump body is carrying out infusion or not according to the latest infusion history record stored in the pump body, and outputting prompt information according to a judgment result; the pump body is used for infusion and for keeping the infusion history of the pump body.

Description

Infusion control method and device, infusion system and pump body device
Technical Field
The invention relates to the technical field of machinery, in particular to an infusion control method and device, an infusion system and a pump body device.
Background
An insulin pump is an insulin infusion system for simulating the pancreas of a human body to secrete insulin, and achieves the purposes of controlling the blood sugar level of a diabetic patient and reducing blood sugar fluctuation by continuously infusing a small amount of insulin into the human body. The traditional insulin pump mostly adopts the design of integrating a medicine storage device, an injection mechanism and a control display panel, a user inputs various insulin pump operation parameters such as a basal rate plan and a large-dose injection amount through control panel buttons on a pump body, and various states such as starting and stopping of the insulin pump are controlled. Regular, quantitative, routine infusions are typically provided to ensure basic control of blood glucose levels; in addition, in special cases, such as in some cases before a large amount of food is needed, the injection amount may be increased additionally, in which case the large dose is administered to meet the current special demand for insulin. When a bolus infusion is performed, the user is required to manually operate the controls to send infusion instructions to the pump body.
As a portable medical device requiring a long-term operation for 24 hours, an insulin pump has been developed in a direction of being miniaturized and portable, and since an integrated structure is not favorable for reducing the volume of the device, a new product form in which an injection mechanism and a controller are separated has appeared in recent years. Fig. 1 is a schematic diagram of the basic components of an infusion system in connection with the present invention, and as shown in fig. 1, the infusion system generally includes a pump body and a controller, wherein the pump body is secured to a person and communicates with the controller (exemplified by a hand-held controller).
The insulin pump body as the injection execution unit has no parts such as a control display panel and the like, the volume can be made small, and even the insulin pump body can be directly pasted on the injection part of a human body; and the portable handheld controller bears the functions of inputting control commands, monitoring the operation of the pump body and the like, and interacts with the pump body in short-distance wireless communication modes such as Bluetooth and the like. Because the size is not limited, the controller can be developed based on the latest mobile intelligent terminal platform, the appearance of the controller is similar to that of a mobile phone, and the controller is provided with modern human-computer interaction interfaces such as a large-size color touch screen, so that the user experience and the equipment intelligence degree are greatly improved.
The design of a product for controlling an insulin pump in a wireless manner can raise the convenience of users and also create new problems. Since the short-distance wireless communication technologies such as bluetooth and wifi generally have limitations on communication distance and communication quality is susceptible to environment, a user inevitably encounters abnormal situations such as unsmooth communication connection or failure in a daily use process, which may cause excessive infusion, as shown in fig. 2, fig. 2 is a schematic diagram of a flow of excessive infusion caused by communication failure.
Therefore, when a wireless communication protocol of the controller and the pump body is designed, a fault tolerance and failure recovery mechanism under the condition of abnormal communication needs to be fully considered, and the safety and reliability of the insulin infusion process are ensured to the maximum extent through communication data verification, confirmation, failure detection, retransmission and other means.
However, unlike other control commands such as basal rate setting, the special operation of bolus infusion has the characteristic of superposition of effects of multiple commands, and the safety and reliability of the infusion process are still to be improved only by means of fault tolerance and failure recovery mechanisms on communication.
Disclosure of Invention
In view of the above, the present invention provides an infusion control method and device, an infusion system and a pump body device, which are helpful to improve the safety and reliability of the infusion process.
The invention provides the following technical scheme:
an infusion system comprising a pump body for infusion and a controller, wherein: the controller is used for controlling the pump body to carry out infusion, acquiring an infusion history record stored in the pump body, judging whether the pump body is carrying out infusion or not according to the latest infusion history record stored in the pump body, and outputting prompt information according to a judgment result; the pump body is used for infusion and for keeping the infusion history of the pump body.
Optionally, in a case that the determination result is yes, the prompt information includes a current infusion progress.
Optionally, the controller is further configured to terminate the current process if the communication with the pump body times out.
Optionally, in a case that the determination result is negative, the controller is further configured to obtain a last infusion history stored in the pump body and present the last infusion history on a human-computer interface, so that a user can confirm whether to send an infusion instruction.
Optionally, in a case that the determination result is negative, the controller is further configured to synchronize the infusion history stored locally with the infusion history stored in the pump body, and present the local latest infusion history after synchronization on a human-machine interface, so that a user can confirm whether the controller needs to send an infusion instruction to the pump body.
Optionally, the pump body is an insulin pump.
An infusion control method comprising: step 1: the controller receives an infusion operation instruction initiated by a user through a human-computer interface; step 2: the controller inquires the last infusion history cached by the pump body; and step 3: the controller judges whether the pump body is infusing according to the last infusion history record, if so, the step 10 is carried out, and if not, the step 4 is carried out; and 4, step 4: the controller acquires a local-saved last infusion history record; and 5: the controller compares whether the locally stored last infusion history is consistent with the last infusion history cached by the pump body, if so, the step 7 is carried out, and if not, the step 6 is carried out; step 6: the controller acquires the cached infusion history of the pump body from the pump body and stores the infusion history to the local; and 7: the controller presents the information of the latest infusion stored locally through a human-computer interface so that a user can confirm whether the controller needs to send an infusion instruction to the pump body; and 8: the controller judges according to the confirmation result of the user, if the user confirms that the result is yes, the step 9 is entered, otherwise, the flow is ended; and step 9: the controller sends an infusion instruction to the pump body; step 10: the controller presents the current infusion schedule via a human-machine interface.
An infusion control device comprising: the first module is used for receiving an infusion operation instruction initiated by a user through a human-computer interface; the second module is used for inquiring the last infusion history cached by the pump body; the third module is used for judging whether the pump body is infusing according to the last infusion history record, if so, the tenth module is triggered, and otherwise, the fourth module is triggered; the fourth module is used for acquiring a local-stored latest infusion history; the fifth module is used for comparing whether the locally stored last infusion history is consistent with the last infusion history cached by the pump body or not, if so, the seventh module is triggered, and otherwise, the sixth module is triggered; the sixth module is used for acquiring the cached infusion history of the pump body from the pump body and storing the infusion history to the local; the seventh module is used for presenting the information of the latest infusion stored locally through a human-computer interface so as to enable a user to confirm whether the controller is required to send an infusion instruction to the pump body; the eighth module is used for judging according to the confirmation result of the user, if the confirmation result of the user is yes, the ninth module is triggered, and if not, the process is ended; the ninth module is used for sending an infusion instruction to the pump body; and the tenth module is used for presenting the current infusion progress through a human-computer interface.
Optionally, the infusion control device is provided in a controller of the insulin pump.
A pump body arrangement, provided in a pump body, comprising: the recording module is used for recording the infusion progress after the infusion is started; the sending module is used for sending the last infusion history cached by the pump body to the controller and sending all the infusion histories cached by the pump body to the controller; and the receiving module is used for receiving the infusion instruction sent by the controller.
Optionally, the pump body is an insulin pump.
According to the technical scheme of the embodiment of the invention, the pump body records the infusion fact and obtains the infusion fact by the controller, and the controller presents the infusion fact to the user so that the user can know whether the infusion is actually performed recently and decide whether the infusion is performed. When the user grasps the real situation of the infusion, the occurrence of the over-infusion can be more effectively avoided.
Drawings
For purposes of illustration and not limitation, the present invention will now be described in accordance with its preferred embodiments, particularly with reference to the accompanying drawings, in which:
FIG. 1 is a schematic diagram of the basic components of an infusion system relevant to the present invention;
FIG. 2 is a schematic diagram of a flow chart in which communication failure causes excessive infusion;
fig. 3 is a schematic diagram of an infusion control method according to an embodiment of the present invention.
Detailed Description
In the embodiment of the invention, taking the treatment of large-dose insulin infusion as an example, when a user initiates the large-dose insulin infusion, the controller judges whether the pump body is infusing according to the latest historical record stored in the pump body, and prompt information is presented on a human-computer interface of the controller. Specifically, the current infusion schedule is displayed if an infusion is being performed, otherwise text such as "bolus infusion is not currently performed" or other text is displayed. Each history record contains bolus infusion status information from which it can be determined whether an infusion is ongoing. The status information may be indicated by a bolus infusion rate, when the rate is greater than zero indicating that a bolus infusion is in progress, and the rate is zero indicating that no infusion is currently in progress. At the beginning and ending time of the bolus infusion (marked by the start and stop of the dosing mechanism of the insulin pump), the pump body respectively generates a historical record, in the historical record of the beginning time, the bolus infusion rate is greater than zero, and in the historical record of the ending time, the bolus infusion rate is equal to zero. The bolus infusion rate is determined by the structure of the product. Thus, if the bolus rate of the pump body is not zero in the last history, it is an indication that bolus infusion is still in progress. This manner of rate-dependent determination is easier to implement than directly detecting liquid flow. In addition, the infusion volume for this bolus can be calculated from the history of the infusion start and end: infusion amount × (end time-start time) bolus infusion rate at start. Therefore, the infusion amount and time of the last large dose can be obtained for the user to confirm.
If no bolus infusion is currently being performed, the user is presented with the time of the last bolus infusion at the human machine interface for the user to decide whether or not to perform a bolus infusion at that time. In embodiments of the invention, the pump body can maintain a history of its infusions, so the controller can retrieve the record from the pump body and provide it to the user.
The controller can also save the history records to the local because the controller can be provided with larger memory compared with the pump body so as to save more history records for a user to view or perform data analysis, and when a large-dose infusion is performed for the last time, the controller firstly obtains the locally saved history records, and the local recent history records are compared with the recent history records obtained from the pump body by the controller at the moment and the content saved by the controller is synchronized as the content saved by the pump body under the condition that the local recent history records and the recent history records are not completely transmitted to the controller due to communication abnormality.
In addition, during the above process, if the communication times out, the process is ended and the user is prompted to reinitiate the bolus infusion operation using the controller. The above flow is shown in fig. 3, and fig. 3 is a schematic diagram of an infusion control method according to an embodiment of the present invention, including steps 1 to 10 as follows.
Step 1: the controller receives an infusion operation instruction initiated by a user through a human-computer interface;
step 2: the controller inquires the last infusion history cached by the pump body;
and step 3: the controller judges whether the pump body is infusing according to the last infusion history record, if so, the step 10 is carried out, and if not, the step 4 is carried out;
and 4, step 4: the controller acquires a local-saved last infusion history record;
and 5: the controller compares whether the last infusion history stored locally is consistent with the last infusion history cached by the pump body, if so, the step 7 is carried out, and if not, the step 6 is carried out;
step 6: the controller carries out recording synchronization, acquires the infusion history cached by the pump body from the pump body and stores the infusion history to the local;
and 7: the controller presents the infusion history of the last infusion stored locally through a human-computer interface so that a user can confirm whether the controller needs to send an infusion instruction to the pump body;
and 8: the controller judges whether to send an infusion instruction according to the confirmation result of the user, if so, the step 9 is carried out, otherwise, the flow is ended;
and step 9: the controller sends an infusion instruction to the pump body;
step 10: the controller presents the current infusion schedule via a human-machine interface.
For the purpose of describing simplification, the step of timeout processing is omitted from the steps listed above, and in implementation, a timeout judgment as shown in the figure can be added to the related steps, and the flow is directly ended in the case that the communication between the controller and the pump body is timed out, and prompt information can be presented to a user.
The controller is provided with infusion control device software to realize the control method, and the infusion control device software can comprise the following functional modules:
the first module is used for receiving an infusion operation instruction initiated by a user through a human-computer interface;
the second module is used for inquiring the last infusion history cached by the pump body;
the third module is used for judging whether the pump body is infusing according to the last infusion history record, if so, the tenth module is triggered, and otherwise, the fourth module is triggered;
the fourth module is used for acquiring a local-stored latest infusion history;
the fifth module is used for comparing whether the locally stored last infusion history is consistent with the last infusion history cached by the pump body or not, if so, the seventh module is triggered, and otherwise, the sixth module is triggered;
the sixth module is used for acquiring the cached infusion history of the pump body from the pump body and storing the infusion history to the local;
the seventh module is used for presenting the information of the latest infusion stored locally through a human-computer interface so as to enable a user to confirm whether the controller is required to send an infusion instruction to the pump body;
the eighth module is used for judging according to the confirmation result of the user, if the confirmation result of the user is yes, the ninth module is triggered, and if not, the process is ended;
the ninth module is used for sending an infusion instruction to the pump body;
and the tenth module is used for presenting the current infusion progress through a human-computer interface.
Generally, the above control method can be provided in various infusion controllers for controlling a pump body for performing an infusion operation, such as a controller of an insulin pump. In addition, the software can also be provided with an overtime processing module, the current flow is stopped under the condition that the communication between the controller and the pump body is overtime, and a prompt can be sent to a user. Correspondingly, a pump body device serving as software can be arranged in the pump body and comprises a recording module, a sending module and a receiving module, wherein the recording module is used for recording the infusion progress after the infusion starts; the sending module is used for sending the last infusion history cached by the pump body to the controller and sending all the infusion histories cached by the pump body to the controller; and the receiving module is used for receiving the infusion instruction sent by the controller. The recording module here records only after the infusion has started, confirming that the record corresponds to the fact that the infusion occurred.
In the prior art, a special large-dose infusion control and confirmation process is adopted to ensure that safety risks such as wrong infusion or excessive infusion cannot occur, for example, when a user initiates a large-dose injection command through a controller, the pump body starts large-dose injection after successfully receiving the command, and meanwhile, the pump body needs to return confirmation information of the command to the controller so that the controller knows that the command is successfully received. If the confirmation information is not received by the controller due to wireless communication interference, the controller considers that the command transmission fails and displays the related prompt information. The user mistakenly believes that the infusion of the pump body bolus does not start, and possibly sends out a bolus infusion command again through the controller, if a new bolus command is also received by the pump body and starts to inject, the two superposed bolus doses can cause excessive insulin infusion, and the dangerous condition of hypoglycemia can occur to the user. According to the technical scheme of the embodiment of the invention, the pump body records the infusion fact and the infusion fact is acquired by the controller, and the controller presents the infusion fact to the user so that the user can know whether the infusion is actually performed recently and decide whether the infusion is performed. When the user grasps the real situation of the infusion, the occurrence of the over-infusion can be more effectively avoided.
The above-described embodiments should not be construed as limiting the scope of the invention. Those skilled in the art will appreciate that various modifications, combinations, sub-combinations, and substitutions can occur, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (11)

1. An infusion system comprising a controller and a pump body for infusion, wherein:
the controller is used for controlling the pump body to carry out infusion, acquiring an infusion history record stored in the pump body, judging whether the pump body is carrying out infusion or not according to the latest infusion history record stored in the pump body, and outputting prompt information according to a judgment result;
the pump body is used for infusion and for keeping the infusion history of the pump body.
2. The infusion system of claim 1, wherein the prompting message includes a current infusion progress if the determination is yes.
3. The infusion system of claim 1, wherein the controller is further configured to terminate a current process if communication with the pump body times out.
4. The infusion system of claim 1, 2 or 3, wherein in the event that the determination is negative, the controller is further configured to obtain a last infusion history stored in the pump body and present the last infusion history in the human-machine interface for the user to confirm whether to send the infusion instruction.
5. The infusion system of claim 1, 2 or 3, wherein in the event that the determination is negative, the controller is further configured to synchronize the locally stored infusion history with the infusion history stored in the pump body, and present the locally most recent infusion history after synchronization to the human machine interface for the user to confirm whether the controller is required to send an infusion instruction to the pump body.
6. The infusion system of claim 1, 2 or 3, wherein the pump body is an insulin pump.
7. An infusion control method, comprising:
step 1: the controller receives an infusion operation instruction initiated by a user through a human-computer interface;
step 2: the controller inquires the last infusion history cached by the pump body;
and step 3: the controller judges whether the pump body is infusing according to the last infusion history record, if so, the step 10 is carried out, and if not, the step 4 is carried out;
and 4, step 4: the controller acquires a local-saved last infusion history record;
and 5: the controller compares whether the locally stored last infusion history is consistent with the last infusion history cached by the pump body, if so, the step 7 is carried out, and if not, the step 6 is carried out;
step 6: the controller acquires the cached infusion history of the pump body from the pump body and stores the infusion history to the local;
and 7: the controller presents the information of the latest infusion stored locally through a human-computer interface so that a user can confirm whether the controller needs to send an infusion instruction to the pump body;
and 8: the controller judges according to the confirmation result of the user, if the user confirms that the result is yes, the step 9 is entered, otherwise, the flow is ended;
and step 9: the controller sends an infusion instruction to the pump body;
step 10: the controller presents the current infusion schedule via a human-machine interface.
8. An infusion control device, comprising:
the first module is used for receiving an infusion operation instruction initiated by a user through a human-computer interface;
the second module is used for inquiring the last infusion history cached by the pump body;
the third module is used for judging whether the pump body is infusing according to the last infusion history record, if so, the tenth module is triggered, and otherwise, the fourth module is triggered;
the fourth module is used for acquiring a local-stored latest infusion history;
the fifth module is used for comparing whether the locally stored last infusion history is consistent with the last infusion history cached by the pump body or not, if so, the seventh module is triggered, and otherwise, the sixth module is triggered;
the sixth module is used for acquiring the cached infusion history of the pump body from the pump body and storing the infusion history to the local;
the seventh module is used for presenting the information of the latest infusion stored locally through a human-computer interface so as to enable a user to confirm whether the controller is required to send an infusion instruction to the pump body;
the eighth module is used for judging according to the confirmation result of the user, if the confirmation result of the user is yes, the ninth module is triggered, and if not, the process is ended;
the ninth module is used for sending an infusion instruction to the pump body;
and the tenth module is used for presenting the current infusion progress through a human-computer interface.
9. The infusion control device of claim 8, being provided in a controller of an insulin pump.
10. A pump body device provided in a pump body, characterized by comprising:
the recording module is used for recording the infusion progress after the infusion is started;
the sending module is used for sending the last infusion history cached by the pump body to the controller and sending all the infusion histories cached by the pump body to the controller;
and the receiving module is used for receiving the infusion instruction sent by the controller.
11. The pump body device of claim 10, wherein the pump body is an insulin pump.
CN202011240128.7A 2020-11-09 2020-11-09 Infusion control method and device, infusion system and pump body device Pending CN112472913A (en)

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PCT/CN2021/129254 WO2022095993A1 (en) 2020-11-09 2021-11-08 Infusion control method and device, infusion system, and pump body device

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