Digital communication module for self-contained medical device communication platform

Abstract

A digital communication module for a self-sufficient medical device communication platform is disclosed herein. In one example, the digital communication module is communicatively coupled to a therapy module of a medical device to forward medical device data to an electronic medical record ("EMR") server connected to a medical network. The digital communication module connects to at least one other digital communication module via a wireless proprietary network separate from the medical network. The digital communication module determines that medical device data from the medical device is to be transmitted to one of the other digital communication modules via the wireless proprietary network, the other digital communication module being connected to the EMR server via the medical network. The other digital communication module receives the medical device data, which is subsequently routed to the EMR server via the medical network.

Description

Background Technology

[0001] Medical networks used in healthcare facilities typically connect to a large number of medical devices. Known medical networks generally include local area networks (“LANs”) and / or wireless LANs (“WLANs”), such as Wi-Fi or Ethernet connections. In such networks, connected medical devices transmit medical data and / or medical event data (e.g., warnings or alarms) to a central gateway or server. The central server or gateway then stores the medical data and / or medical event data in the appropriate patient electronic medical record (“EMR”). The central server may also transmit medical data and / or medical event data to clinicians’ computers for monitoring. Where permissible, the central server may also route prescriptions and / or medical device scheduling instructions to the appropriate medical devices.

[0002] In the aforementioned medical network, the medical devices are only configured with the destination network address of the central server or gateway. Therefore, communication is limited to the connection between the medical device and the central server or gateway. As mentioned above, the server or gateway determines how to route medical data and / or medical event data on the medical network. Known medical networks leave medical devices at the edge or endpoint of the network, which limits or prevents the interconnectivity of medical devices.

[0003] Another known problem with medical networks is that their overall operability is limited by the network configuration specified by the healthcare facility. Because medical networks in healthcare facilities are designed for security and reliability, enhanced features or device interconnectivity are typically not considered or deployed in known medical networks. In one example, a medical device might include enhanced network operability, such as the ability to communicate with other medical devices or sensors. However, such features are only operable if the medical network is configured to allow inter-device communication. Due to cost, workload, and potential risks, healthcare facilities typically do not modify or upgrade their networks to support such features. Adapting a network to support the specific features of dozens to hundreds of different medical devices is cumbersome and risks having one feature or medical device break the entire network. Due to the limited functionality offered by medical networks, some medical device functionalities are never used or even designed or implemented.

[0004] Therefore, there is a need for a medical system that does not limit the characteristics or operation of medical devices. There is also a need for a medical system that enables interconnectivity of medical devices. Summary of the Invention

[0005] This document discloses example systems, methods, and apparatuses for creating self-contained networks implemented within medical devices. The medical devices disclosed herein include or are connected to a digital communication module (“DCM”). A digital communication module may also be referred to as a digital communication device. An example DCM is located between the processor (or therapeutic module) of the medical device and a medical network. In some embodiments, the DCM is external to the medical device (connected via a serial connection or Ethernet connection). In other embodiments, the DCM is included within or integrated with the medical device.

[0006] According to the first independent aspect, a medical system is provided, comprising: - At least one medical device (104), comprising: • One or more sensors and one or more actuators, • Memory, and The processor (107) is configured to receive data from the one or more sensors and control the one or more actuators to perform medical tasks. The processor (107) is able to access the memory and is configured to store data including medical device data (303); • A communication unit connected to the processor (107), the communication unit including at least one of a serial input port, an Ethernet input port and a wireless input port; - At least one digital communication module (102) associated with the medical device (104), the digital communication module (102) comprising: • An input interface (304) is coupled for communicating with a communication unit of the medical device (104), and the input interface (304) includes at least one of a serial input port, an Ethernet input port, and a wireless input port; • An output interface (306) is configured to be communicatively coupled to (i) an electronic medical record (EMR) server (108) via a medical network (106) and communicatively coupled to (ii) at least one other digital communication module (102A) via a wireless private network (400). The output interface (306) includes at least one of a serial output port, an Ethernet output port, or a wireless output port. • A file configuration manager (330) is configured to store at least one configuration file (332) having an identifier of a digital communication module (102); and • Data manager (302), communicatively coupled to input interface (304), output interface (306), and file configuration manager (330), is configured as follows: ■ Upon power-on, a wake-up message is transmitted via a wireless private network (400) to the at least one other digital communication module (102A). The wake-up message includes the identifier of the digital communication module (102) and a date / time indication of power-on. ■ Receives a response message from each of at least one other digital communication module (102A) via a wireless private network (400). The response message includes the identifier or network address of each other digital communication module (102A) and a date / time indication of when each other digital communication module (102A) is powered on. ■ Receive medical device data (303) from medical device (104), ■ Determine the medical device data (303) to be transmitted to the EMR server (108) via the first digital communication module (102A) having the earliest date / time indication, and ■ Transmit medical device data (303) to the first digital communication module (102) for transmission to the EMR server (108).

[0007] In a second independent aspect, a medical system is provided, comprising: - At least one medical device (104), comprising: • One or more sensors and one or more actuators, • Memory, and • A processor (107) is configured to receive data from the one or more sensors and control the one or more actuators to perform medical tasks, wherein the processor (107) is able to access the memory and is configured to store data including medical device data (303); • A communication unit connected to the processor (107), the communication unit including at least one of a serial input port, an Ethernet input port and a wireless input port; - At least one digital communication module (102) associated with the medical device (104), the digital communication module (102) comprising: • An input interface (304) is coupled for communicating with a communication unit of the medical device (104), and the input interface (304) includes at least one of a serial input port, an Ethernet input port, and a wireless input port; • Output interface (306) is configured to be communicatively coupled to (i) at least one other digital communication module (102A) via a wireless proprietary network (400) and to (ii) a clinician device via a wireless proprietary network (400) or a direct wireless link. The output interface (306) includes at least one of an Ethernet output port or a wireless output port. • A file configuration manager (330) is configured to store at least one configuration file (332), the at least one configuration file having a network address or identifier of the clinician device and criteria for transmitting notifications to the clinician device; and • Data manager (302), communicatively coupled to input interface (304), output interface (306), and file configuration manager (330), is configured as follows: o Receives medical device data (303) from medical device (104), o Determine that at least some of the medical device data in the medical device data (303) meets the standard. o Transmits a notification message to the clinician device (322) via a proprietary network (400) or a direct wireless link, the notification message indicating that at least some of the medical device data (303) meets the standard.

[0008] In another independent aspect, a method is provided for transmitting medical device data (303) from at least one medical device (104) to an EMR server (108) via at least one digital communication module (102), wherein the medical device (104) includes: • One or more sensors and one or more actuators, • Memory, and • A processor (107) is configured to receive data from the one or more sensors and control the one or more actuators to perform medical tasks, wherein the processor (107) is able to access the memory and is configured to store data including medical device data (303); • A communication unit connected to the processor (107), the communication unit including at least one of a serial input port, an Ethernet input port and a wireless input port; The digital communication module (102) includes: • An input interface (304) is coupled for communicating with a communication unit of the medical device (104), and the input interface (304) includes at least one of a serial input port, an Ethernet input port, and a wireless input port; • An output interface (306) is configured to be communicatively coupled to (i) an electronic medical record (EMR) server (108) via a medical network (106) and to (ii) at least one other digital communication module (102A) via a wireless private network (400). The output interface (306) includes at least one of a serial output port, an Ethernet output port, or a wireless output port. • A file configuration manager (330) is configured to store at least one configuration file (332) having an identifier of a digital communication module (102); and • The data manager (302) is communication-coupled to the input interface (304), the output interface (306), and the file configuration manager (330). The method includes: ■ The digital communication module (102) is coupled to the medical device (104). ■ Couple the digital communication module (102) to the EMR server (108), ■ Upon power-on, a wake-up message is transmitted via a wireless private network (400) to the at least one other digital communication module (102A) through a data manager (302). The wake-up message includes the identifier of the digital communication module (102) and a date / time indication of power-on. ■ Receive a response message from each of the at least one other digital communication module (102A) via a wireless private network (400). The response message includes the identifier or network address of each other digital communication module (102A) and a date / time indication of when each other digital communication module (102A) is powered on. ■ Receive medical device data (303) from medical device (104), ■ Determine the medical device data (303) to be transmitted to the EMR server (108) via the first digital communication module (102A) having the earliest date / time indication, and ■ Transmit medical device data (303) to the first digital communication module (102) for transmission to the EMR server (108).

[0009] Further details of the system and the process are provided in the following paragraphs. The following aspects relate to the system and communication modules (either themselves or part of the system); however, process steps performed by one or more processors of the medical device and one or more data managers of the digital communication modules may also be part of the methods described above for transferring data from the medical device.

[0010] In a third aspect according to any of the foregoing aspects, the medical system includes a plurality of medical devices (104) and a plurality of digital communication modules (102A-0, ..., 102A-6), each of the plurality of medical devices (104) being associated with one of the plurality of digital communication modules (102).

[0011] In the fourth aspect of the foregoing, the plurality of medical devices (104) include medical devices of different natures selected from the group consisting of one or more devices for treating kidney disease, one or more infusion pumps, one or more nutrient fluid delivery devices, one or more plasma exchange machines, and one or more medical purified water preparation machines.

[0012] In the fifth aspect according to either of the two aspects mentioned above, the digital communication module (102) is configured as a gateway that enables the digital communication modules (102A-0, ..., 102A-6) in the mesh configuration network to communicate with each other independently of the medical network (106) associated with the healthcare facility.

[0013] In the sixth aspect according to any of the three aspects mentioned above, the plurality of digital communication modules (102A-0, ..., 102A-6) are configured to designate one digital communication module (102) as a node gateway connected (optionally, uniquely connected) to the medical network (106). In particular, each of the plurality of digital communication modules (102A-0, ..., 102A-6) transmits its respective medical device data (303) to the node gateway digital communication module at least once, which routes the received medical device data (303) to the medical network (108). Optionally, the node gateway digital communication module communicates with the medical network (106) at periodic intervals.

[0014] In the seventh aspect according to any of the four aspects mentioned above, the plurality of digital communication modules (102A-0, ..., 102A-6) are configured to communicate with each other and create a self-contained proprietary wireless network (400) hosted by the plurality of digital communication modules (e.g., IoT gateways) associated with the plurality of medical devices (104).

[0015] In the eighth aspect according to the foregoing, the self-contained patented wireless network (400) is configured to transmit medical device data (303) in digital communication modules (102A-0, ..., 102A-6) for single-point transmission to a medical network (106).

[0016] In another aspect 8, the self-contained proprietary wireless network (400) is configured to share the same medical device data (303) among digital communication modules (102A-0, ..., 102A-6) connected to the self-contained proprietary wireless network (400).

[0017] In the ninth aspect according to any of the foregoing aspects, the medical device (104) is a medical fluid delivery machine, wherein the one or more actuators include one or more pumps.

[0018] In the 10th aspect according to any of the foregoing aspects, the medical device (104) is a device for treating kidney disease, such as a continuous renal replacement therapy “CRRT” machine, a hemodialysis machine or a peritoneal dialysis machine, including a disposable tubing set, wherein the one or more actuators include one or more pumps.

[0019] In the eleventh aspect according to any of the foregoing aspects, the medical device (104) is a device for treating kidney disease using extracorporeal blood circulation, comprising: - The filtration unit has a primary chamber and a secondary chamber separated by a semi-permeable membrane; - Blood circulation circuits, including: • The blood collection tubing extends between a first end, which connects to the inlet of the primary chamber, and a second end, which connects to the patient; and • A blood return line extends between a first end that connects to the outlet of the primary chamber and a second end that connects to the patient; - A blood pump is used to circulate blood in the blood circuit; - Dialysis fluid line, connected to the outlet of the secondary chamber; - Optionally, one or more tubing lines for transferring their respective solutions into the bloodstream.

[0020] In the 12th aspect according to any of the foregoing aspects, the medical device data (303) includes both medical treatment data and medical event data, such as warnings or alarms.

[0021] In the 13th aspect according to any of the foregoing aspects, the system also includes a medical network (106) and an electronic medical record (EMR) server (108).

[0022] In the 14th aspect according to any of the foregoing aspects, the digital communication module (102) is located outside the housing of the medical device (104) and is physically connected to the medical device (104) via a serial connection or an Ethernet connection, or alternatively, via a wireless connection.

[0023] In the 15th aspect according to any one of the foregoing aspects 1 to 13, the digital communication module (102) is included within or integrated with the housing of the medical device (104).

[0024] In the 16th aspect according to any of the foregoing aspects, the system further includes a medical network and an electronic medical record (EMR) server (108), wherein the medical network (106) includes at least one of a Wi-Fi network or an Ethernet network, and the digital communication module (102) transmits medical device data (303) to the medical network for inclusion in the EMR server (108).

[0025] In the 17th aspect of the foregoing, the medical network (106) includes at least one of a local area network (LAN), a wireless LAN (WLAN), an Ethernet network, and a Wi-Fi network, as well as one or more communication elements from the group consisting of a gateway, a router, a system hub, a switch, and network devices for establishing communication connections and routing data. In particular, the medical network (106) includes one or more firewalls that restrict access to authorized remote devices only.

[0026] In aspect 18 according to any of the foregoing aspects, when subordinate to aspect 7, the proprietary wireless communication network (400) is separated from the medical network.

[0027] In another aspect of any of the foregoing aspects, the medical system includes a clinician device (322) connected to the digital communication module (102) via a proprietary network (400) or a direct wireless link, wherein the clinician device (322) does not need to be connected to the medical network (106) to receive notification messages, and in particular, the clinician device (322) is not connected to the medical network (106).

[0028] In a 19th independent aspect, a digital communication module (102) is provided, comprising: an input interface (304) configured for communication coupling to a medical device (104); the input interface (304) including at least one of a serial input port, an Ethernet input port, and a wireless input port; The output interface (306) is configured to be communicatively coupled to (i) an electronic medical record (EMR) server (108) via a medical network (106) and (ii) communicatively coupled to (ii) at least one other digital communication module (102A) via a wireless private network (400), the output interface (306) including at least one of a serial output port, an Ethernet output port or a wireless output port; A file configuration manager (330) is configured to store at least one configuration file (332) having an identifier for a digital communication module (102); and The data manager (302), communicatively coupled to the input interface (304), output interface (306), and file configuration manager (330), is configured as follows: After power-on, a wake-up message is transmitted via a wireless private network (400) to at least one other digital communication module (102A). The wake-up message includes the identifier of the digital communication module (102) and a date / time indication of power-on. A response message is received via a wireless private network (400) from each of the at least one other digital communication module (102A). The response message includes the identifier or network address of the corresponding other digital communication module (102A) and a date / time indication of when the corresponding other digital communication module (102A) is powered on. Receive medical device data (303) from medical device (104), The medical device data (303) to be transmitted to the EMR server (108) via the first digital communication module (102A) with the earliest date / time indication is determined, and The medical device data (303) is transmitted to the first digital communication module (102) for transmission to the EMR server (108).

[0029] In the 20th independent aspect, a digital communication module (102) is provided, comprising: An input interface (304) is configured for communication coupling to a medical device (104), and the input interface (304) includes at least one of a serial input port, an Ethernet input port, and a wireless input port; The output interface (306) is configured to be communicatively coupled to (i) at least one other digital communication module (102A) via a wireless proprietary network (400) and to (ii) a clinician device via a wireless proprietary network (400) or a direct wireless link. The output interface (306) includes at least one of an Ethernet output port or a wireless output port. A file configuration manager (330) is configured to store at least one configuration file (332), the at least one configuration file having a network address or identifier of a clinician device and standards for transmitting notifications to the clinician device; and The data manager (302), communicatively coupled to the input interface (304), output interface (306), and file configuration manager (330), is configured as follows: Receive medical device data (303) from medical device (104), Determine that at least some of the medical device data in the medical device data (303) meets the standard. Notification messages are transmitted to the clinician's device via a private network (400) or a direct wireless link. The notification message indicates that at least some of the data in the medical device (303) meet the criteria.

[0030] Independent aspects 19 and 20 can be combined with any of aspects 1 to 18 mentioned above and the following aspects.

[0031] In accordance with aspect 21 of the foregoing, the wireless private network (400) includes Wireless protocols Wireless protocols At least one of a wireless protocol or a low-power wide-area network (“LPWAN”) wireless protocol, and Among them, direct wireless link is used Wireless protocols Mesh wireless protocol or It is provided by at least one of the 5.0 wireless protocols.

[0032] In aspect 22 of either of the two aforementioned aspects, the direct wireless link is included as part of the wireless private network (400).

[0033] In aspect 23, which is based on any of the three aspects mentioned above, the standard used for notification corresponds to at least one of a warning, alarm, or event.

[0034] In the 24th aspect according to any of the four aspects mentioned above, the data manager (302) is further configured as follows: Allow authorized connections from the clinician device (322); Provide a template form for requesting data about which notifications are expected, including setting thresholds and / or conditions for when to generate notifications, and in particular, a template form for requesting the priority of warnings, events, or alarms; Use template table data to set standards.

[0035] In aspect 25 of any of the five aspects mentioned above, the data manager (302) is configured to broadcast and rebroadcast notification messages to ensure that the messages reach the clinician device (322), wherein the data manager (302) is configured to rebroadcast notification messages until a maximum broadcast time is reached, a maximum number of broadcasts has been performed, or an acknowledgment message is received from the clinician device (322) upon receiving the notification message.

[0036] In aspect 26 according to any of the foregoing aspects, the data manager (302) is further configured to: Receive a power-off message from the first digital communication module (102) indicating that the first digital communication module (102) is no longer available; Remove the date / time indicator from the first digital communication module (102); Receive data (303) from the second medical device from the medical device (104); It is determined that the data from the second medical device (303) will be transmitted to the EMR server (108) via a second digital communication module (102A) with the earliest date / time indication, wherein the date / time indication of the first digital communication module (102) is removed; and The data (303) from the second medical device is transmitted to the second digital communication module (102) for transmission to the EMR server (108).

[0037] In aspect 27 according to any of the foregoing aspects, the data manager (302) is further configured to: Receive a power-off message from the first digital communication module (102) indicating that the first digital communication module (102) is no longer available; Remove the date / time indicator from the first digital communication module (102); Receive data (303) from the second medical device from the medical device (104); Based on the fact that the digital communication module (102) has the earliest date / time indication among the other digital communication modules (102A), it is determined that the second medical device data (303) will be transmitted to the EMR server (108) via the digital communication module (102); and The second medical device data (303) is transmitted to the EMR server (108) via communication coupling from the output interface (306) to the medical network (106).

[0038] In accordance with aspect 28 of the foregoing, the data manager (302) is further configured as follows: Receive data (303) from a third medical device from one of the other digital communication modules (102A); and The third medical device data (303) is transmitted to the EMR server (108) via communication coupling from the output interface (306) to the medical network (106).

[0039] In aspect 29, according to either of the two aspects mentioned above, the data manager (302) is further configured as follows: The new first digital communication module (102) is designated as the node gateway for transmitting medical device data (303); and After receiving a power failure message from the first digital communication module (102) and determining that the new digital communication module (102) has the earliest date / time indication among the other digital communication modules (102A), the new digital communication module (102) is designated as the node gateway.

[0040] In the 30th aspect of the foregoing, the data manager (302) is further configured to disable communication coupling to the EMR server (108) via the output interface (306) after designating the new first digital communication module (102) as the node gateway.

[0041] In aspect 31 according to any of the foregoing aspects, the data manager (302) is further configured to: Receive first disposable or consumable usage information from the medical device (104); Receive second disposable or consumable usage information from other digital communication modules (102A); combine the first disposable or consumable usage information with the second disposable or consumable usage information; and Through communication coupling from the output interface (306) to the medical network (106), combined first disposable or consumable usage information and second disposable or consumable usage information are transmitted to at least one of the EMR server (108) or medical supply server.

[0042] In aspect 32 of the foregoing, the digital communication module (102) further includes a database and a log manager (334) that maintains log files in the database (324) that track the use of disposable items / consumables.

[0043] In the 33rd aspect of either of the two preceding aspects, the first and second disposable product usage information includes information indicating the use of filters, disposable cartridges, tubing sets, dialysis solutions, saline solutions, renal replacement solutions, warming bags, or disposable sensors.

[0044] In the 34th aspect according to any of the three aspects mentioned above, the processor (107) is configured to monitor the treatment delivery through the medical device and determine information on the use of disposable or consumable items, particularly at the end of the treatment phase, the information on the use of disposable or consumable items includes: • The type and quantity of single-use, disposable items that have been used and must be replaced to perform subsequent treatments, such as disposable tubing sets; and / or • The type and quantity of semi-disposable components that are depleted or must be replaced, such as concentrates used for dialysis fluid preparation or ultrafiltration; and / or • The type and number of broken components that must be replaced, such as sensors or actuators. The processor (107) stores the usage information of disposable items or consumables in the memory, and the usage information of disposable items or consumables is transferred to the digital communication module (102) through the communication unit.

[0045] In aspect 35 according to any of the four aspects mentioned above, the data manager (302) of each of the plurality of digital communication modules (102) (102A-0, ..., 102A-6) is configured to communicate its disposable or consumable usage information to the other digital communication modules, and each digital communication module retains fleet aggregate information of all medical devices associated with the respective digital communication module portions of the wireless proprietary network (400).

[0046] In the 36th aspect according to any of the five aspects mentioned above, the digital communication module (102) receives an indication of available inventory, which is input into at least one of the medical devices or received from a server of the medical network (106) via the medical network interface (310); the data manager (302) compares the usage information of disposable items or consumables with the indication of available inventory and generates a supplementary message including information about disposable items or consumables that must be replenished. The supplementary message is sent to the medical network (106) for inventory tracking with the supplier.

[0047] In aspect 37 according to any of the foregoing aspects, the wireless private network (400) includes Wireless protocols Mesh wireless protocol 5.0 wireless protocol Wireless protocols Wireless protocols At least one of a wireless protocol or a low-power wide-area network (“LPWAN”) wireless protocol, and The medical network (106) includes at least one of a Wi-Fi network or an Ethernet network.

[0048] In the 38th aspect according to any of the foregoing aspects, the configuration file (332) specifies the destination network address of the EMR server (108), the identifier of the medical device (104) type of the connected medical device (104), the identifier of the medical device (104) serial number, and a timestamp, according to which medical data received is generated by the medical device (104) or received from the medical device (104) by the data manager (302).

[0049] In aspect 39 according to any of the foregoing aspects, the data manager (302) is further configured to: Receives a stream of data (303) from the medical device; Snapshots of medical device data (303) are created at periodic intervals; and A snapshot of the medical device data (303) is provided as the medical device data (303) transmitted to the first digital communication module (102).

[0050] According to aspect 40 of the foregoing, the periodic interval has a period between five and sixty seconds.

[0051] In aspect 41, according to either of the two aspects mentioned above, the data manager (302) is further configured as follows: Event tracking is used to identify changes in medical device data (303) between snapshots; and only medical device data (303) that has changed from previous snapshots is included as medical device data (303) transmitted to the first digital communication module (102).

[0052] In aspect 42 according to any of the foregoing aspects, the medical device (104) includes at least one of a continuous renal replacement therapy (“CRRT”) machine, a peritoneal dialysis machine, a hemodialysis machine, a water purifier, or a nutrient synthesis machine.

[0053] In the second aspect of the 42nd aspect according to any of the foregoing aspects, the digital communication module (102) is configured to receive medical device data (303) from the medical device, and the communication between the digital communication module (102) and the medical device is unidirectional.

[0054] In aspect 43 according to any of the foregoing aspects, the medical device data (303) includes at least one of the following: Event information, including the transitions between the filling, residence, and discharge phases of the dialysis cycle; Warning, alarm, or event information; Treatment plan information; or Medical treatment data, including at least one of the estimated filling rate, discharge rate, or amount of ultrafiltration removed.

[0055] In aspect 44, as described in any of the foregoing aspects, the data manager (302) is further configured to: A configuration message is received via the output interface (306), which indicates the network address and standard of the clinician device for transmitting notifications to the clinician device; Determine that at least some of the medical device data in the medical device data (303) meets the criteria; and transmit a notification message via a proprietary network (400) to a clinician device, the notification message indicating that the at least some of the medical device data in the medical device data (303) meets the criteria.

[0056] In aspect 45 according to any of the foregoing aspects, the medical system or module further includes at least one other medical device, said at least one other medical device being an infusion pump, wherein the medical device (104) is a dialysis machine. Among them, the at least one other digital communication module (102A) is associated with the infusion pump, and The medical device data (303) from the dialysis machine includes a patient identifier, and the second medical device data (303) from the at least one infusion pump includes the same patient identifier and infusion rate. The data manager (302) is further configured as follows: Receives an indication that adaptive fluid removal operation is enabled; Receive parameter data associated with the patient identifier, which includes one or more of the following: • The flow rate of fresh dialysis fluid entering the filtration unit, • The flow rate of waste liquid leaving the filtration unit • The pre-infusion flow rate entering the extracorporeal blood circuit • Post-infusion flow rate into the extracorporeal blood circuit • Target fluid removal volume and removal cycle • Fluid removal rate Data (303) of the second medical device is received from at least one other digital communication module (102A) via a wireless private network (400); Determine whether the at least one infusion pump is associated with the same patient identifier; The amount of fluid or infusion rate infused into the patient is determined based on data from the second medical device (303); Updated parameter data (303) is determined based on parameter data and the amount or rate of fluid infused into the patient determined from data from the second medical device. In particular, taking into account the fluid infused using the infusion pump, the updated parameters maintain the patient’s fluid balance during dialysis. The updated parameter data is transmitted to the dialysis machine via the input interface (304).

[0057] In accordance with aspect 46 of the foregoing, the data manager (302) is further configured to: receive parameter data related to a patient identifier, the parameter data including: • Target fluid removal volume and removal cycle; or • Fluid removal rate of patients associated with patient identifiers; The updated parameter data is based on at least one updated flow rate for the dialysis machine, such as the fluid removal rate: i) The fluid removal target and removal cycle, or the fluid removal rate; and ii) The volume or rate of fluid infused into the patient; The at least one updated flow rate (such as an updated fluid removal rate) is transmitted to the dialysis machine via the input interface (304).

[0058] In the 46th aspect of the foregoing, determining the at least one updated flow rate includes recalculating one or more flow rates used by the dialysis machine to maintain the patient's fluid balance, the one or more flow rates including one or more of the following: fresh dialysis fluid flow rate entering the filtration unit, waste fluid flow rate leaving the filtration unit, pre-infusion flow rate entering the extracorporeal blood circuit, post-infusion flow rate entering the extracorporeal blood circuit, and fluid removal rate.

[0059] For example, the pre-infusion or post-infusion flow rate can be reduced by the same amount as the infusion flow rate from the infusion pump, thereby keeping all other flow rates constant. Alternatively, the patient fluid removal rate can be increased by the same amount as the infusion flow rate from the infusion pump, thereby keeping all other flow rates constant. Of course, any other combination of fluid alterations that maintains patient fluid balance can be used.

[0060] In aspect 47 of the foregoing, the dialysis machine is a CRRT machine, and the data manager (302) is configured to receive the fluid removal rate of a patient associated with a patient identifier, and to determine an updated fluid removal rate of the dialysis machine and the amount of fluid infused into the patient or the infusion rate based on the fluid removal rate.

[0061] In aspect 48, according to either of the two preceding aspects, the transmission of the updated fluid removal rate causes the dialysis machine to display a recommendation on the screen indicating the updated fluid removal rate.

[0062] In aspect 49 according to any of the three aspects mentioned above, the transmission of the updated fluid removal rate enables the dialysis machine to automatically reprogram the treatment based on the updated fluid removal rate, and enables the processor to drive the actuator to achieve the updated fluid removal rate.

[0063] In aspect 50, according to any of the four aspects mentioned above, the processor (107) of the dialysis machine is configured to compare the updated fluid removal rate with the maximum permissible fluid removal rate and to display an alarm if the updated fluid removal rate exceeds the maximum permissible fluid removal rate.

[0064] In accordance with aspect 51 of the foregoing, if the updated fluid removal rate exceeds the maximum permissible fluid removal rate, the processor (107) proposes a fluid removal rate substantially equal to the maximum permissible fluid removal rate.

[0065] In aspect 52, according to any of the foregoing aspects, the data manager (302) is further configured to: Sensor data is received from the EMR server (108) via the medical network (106); and the sensor data is transmitted to the medical device (104) via the input interface (304) for display on the screen of the medical device (104).

[0066] In aspect 53 according to any of the foregoing aspects, the data manager (302) is further configured as follows: Compare at least some of the medical device data from the sensor data and medical device data (303) with stored standards; and At least one suggestion message is transmitted to the medical device (104) via the input interface (304) to cause the screen to display information indicating the comparison.

[0067] In the 54th aspect according to either of the two aforementioned aspects, sensor data from the EMR server (108) is transmitted to the mailbox (340) of the digital communication module (102), and in particular, sensor data from the EMR server (108) cannot be directly written to the medical device (104).

[0068] In the 55th aspect according to the foregoing, the medical device manager (336) processes sensor data in the mailbox to determine which data will be transmitted to the medical device (104), and in particular, the medical device manager (336) converts the data into a compatible format and transmits it to the processor (107) of the medical device (104).

[0069] According to aspect 56 of any of aspects 53 to 55 above, the data manager (302) is further configured as follows: The ID code of the sensor data that identifies the patient is compared with the patient identifier contained in the medical device data transmitted by the medical device; When the same patient is identified by ID code and patient identifier, sensor data is transmitted to medical device (104) via input interface (304).

[0070] The DCM disclosed herein is configured as a gateway (such as an Internet of Things (“IoT”) gateway), enabling DCMs in a mesh configuration to communicate with each other independently of the healthcare facility’s healthcare network. As disclosed herein, the DCM provides a self-sufficient network without requiring other networking components such as switches, routers, gateways, and / or access points. This self-sufficient configuration allows the DCM to be deployed separately from and / or on top of an established healthcare network without requiring any modifications to the healthcare network. This self-sufficient configuration also enables the DCM to be deployed in locations where no network infrastructure has been established, such as rural or remote areas.

[0071] As disclosed herein, the DCM is configured to provide a proprietary communication network (e.g., a private personal area network). In some embodiments, the DCM may use a wireless protocol to implement the proprietary communication network, such as... Reticulate Low power 5.0 And / or LoRa (Low Power Wide Area Network (“LPWAN”) network protocol). In other examples, proprietary communication networks may use protocols defined by the medical device manufacturer.

[0072] In some embodiments, the DCM receives medical data and / or medical event data (collectively referred to herein as medical device data) from the processor or treatment module of a medical device, such as a continuous kidney replacement therapy (“CRRT”) machine. The DCM transmits at least one stream of the medical device data to a medical network for inclusion in an appropriate EMR. The medical device data may be in JavaScript Object Notation (“JSON”) format, Hypertext Markup Language (“HTML”) format, Extensible Markup Language (“XML”) format, Comma Separated Values ​​(“CSV”) format, text format, and / or Health-Level-7 (“HL7”) format.

[0073] In some embodiments, the DCMs of the medical devices are configured to communicate with each other via a proprietary communication network separate from the hospital network. The DCMs can transmit ping messages to identify other DCMs within the proprietary communication network. In some embodiments, a DCM can designate another DCM as a node gateway connected to the medical network. In these embodiments, the DCM transmits medical device data to the designated node gateway DCM, which routes the received medical device data to the medical network. This configuration of the DCMs provides a singularity in the connection to the medical network, thereby improving the security of the DCMs and reducing network complexity.

[0074] The interconnectivity of the DCMs disclosed herein provides enhanced operability for healthcare providers. In one example, a DCM is configured to track the use of disposable and / or consumable items, such as filters, cartridges, tubing sets, dialysis solutions, kidney replacement solutions, warming bags, etc. DCMs within the same proprietary communications network can share disposable and / or consumable usage information or provide such information to designated node gateway DCMs. At periodic intervals, one of the DCMs (such as a node gateway DCM) communicates total usage information to the healthcare network and / or supplemental servers.

[0075] It should be understood that the DCMs disclosed herein may be incorporated into or connected to more than one type of medical device. In one example, a DCM may be connected to a CRRT machine, while one or more DCMs are equipped with infusion pumps. The example DCMs communicate via a dedicated communication network to determine which DCMs are associated with or provide treatment to the same patient (using patient identifiers entered into the CRRT machine and infusion pumps). The DCMs then communicate medical device data to each other (or the DCM of the infusion pump communicates data to the DCM of the CRRT machine), providing a more comprehensive, data-driven picture of the patient's treatment. In one example, the DCM of the CRRT machine uses infusion rate data from the infusion pump to set and / or modify the patient's fluid removal rate to meet programmed fluid removal goals. In this configuration, the communication of infusion data and the modification of the patient's CRRT treatment occur outside the medical network, making this operability possible via a dedicated communication network provided by a compatible medical device.

[0076] In another embodiment, the example DCM (connected to the CRRT machine) can communicate with the EMR system of a medical facility via a medical network. Certain medical devices (such as blood pressure monitors or blood gas analyzers) are configured to transmit measurement data to the EMR system via the hospital network. The EMR system can then send the measured data to the DCM. In some cases, the DCM causes the received data to be displayed on the CRRT machine. In other cases, the DCM is configured to analyze the received data in conjunction with data from the CRRT machine to determine a treatment recommendation, which is displayed on the CRRT machine's monitor. In still other cases, the DCM is configured to analyze the received data in conjunction with data from the CRRT machine to determine a treatment adjustment, which is then transmitted to the CRRT machine to adjust the ongoing treatment.

[0077] In another embodiment, an example DCM (connected to or integrated with a CRRT machine) can be configured to provide instructions on medical device data to a clinician's device (e.g., a smartphone or tablet). In this example, the clinician device may be wirelessly coupled to the DCM via a dedicated communication network rather than through a hospital network. By configuration, the DCM is provided with the network or hardware address of the clinician device and instructions on what information to transmit. The DCM receives medical device data from the CRRT machine's treatment processor and determines whether any conditions are met for transmitting a notification. The DCM is configured such that if at least one condition is met, a notification message including information indicating the medical device data is transmitted via the dedicated communication network to the designated clinician device. This configuration enables a medical device provider to provide remote alerts and / or warnings directly to clinicians via the example DCM without adapting or limiting the operability of the medical network, or without relying on the medical network to route alerts and / or warnings to the appropriate clinician.

[0078] In the above embodiments, the DCM can communicate with a clinician device via a first protocol, such as those provided in many mobile devices. Furthermore, DCMs can communicate with other DCMs using a different protocol and / or proprietary protocols, which is uncommon in mobile devices. This configuration enables integration of DCMs with mobile devices that have relatively more limited transceivers (options) for wireless communication via proprietary networks.

[0079] The example DCM can operate with any type of medical device or machine, such as those used for fluid delivery in treatments like plasma removal, hemodialysis (“HD”), hemofiltration (“HF”), hemodiafiltration (“HDF”), and continuous renal replacement therapy (“CRRT”). The DCM described herein can also be used for peritoneal dialysis (“PD”), intravenous drug delivery, and nutritional fluid delivery. The different forms of treatment and related devices described above may be collectively referred to herein, or generally individually, as medical fluid delivery or treatment and the associated devices or machines.

[0080] The above-described form can be provided by a medical fluid delivery system that houses the components required for delivering medical fluids, such as one or more pumps, valves, heaters (if needed), in-line medical fluid generation equipment (if needed), sensors (such as any one, multiple, or all of pressure sensors, conductivity sensors, temperature sensors, air detectors, blood leak detectors, etc.), a user interface, and a control unit. The medical fluid delivery system may employ one or more processors and memory to control the aforementioned equipment. The medical fluid delivery system may also include one or more filters, such as dialysis machines or blood filters for cleaning blood, and / or ultrafilters for purifying water, dialysis fluids, or other therapeutic fluids.

[0081] The DCM and medical fluid delivery system described herein can be used with home-based machines. For example, the system can be used with home HD, HF, HDF, or PD machines that operate at the patient's convenience. One such home system is described in U.S. Patent No. 8,029,454 (“'454 Patent”), issued October 4, 2011, entitled “High Convection Home Hemodialysis / Hemofiltration And Sorbent System,” filed November 4, 2004, assigned to the assignee of this application. Other such home systems are described in U.S. Patent No. 8,393,690 (“'690 Patent”), issued March 12, 2013, entitled “Enclosure for a Portable Hemodialysis System,” filed August 27, 2008. The entire contents of each of the above references are incorporated herein by reference and depend on them.

[0082] As described in detail below, the DCM of this disclosure can operate within a comprehensive medical network comprising numerous machines, including various types of devices, patients, clinicians, service personnel, electronic medical record (“EMR”) databases, websites, resource planning systems that process data generated through patient and clinician communications, and business intelligence. The DCM of this disclosure operates seamlessly within the medical network without violating network rules and protocols.

[0083] Therefore, based on this disclosure and the above aspects, the advantage of this disclosure is that it provides a self-contained proprietary wireless network hosted by a digital communication module (e.g., an IoT gateway) associated with a medical device.

[0084] Another advantage of this disclosure is the use of a self-contained network to transmit medical device data and / or consumable / disposable product usage data within a digital communication module for single-point transmission to a medical network.

[0085] Another advantage of this disclosure is that it enables the use of digital communication modules for edge computing in decision support for CRRT machines.

[0086] Another advantage of this disclosure is that it provides a system that provides wireless alarms, warnings or other notifications directly from a medical device to a mobile clinician device.

[0087] Additional features and advantages are described in the following detailed description and accompanying drawings, and will be apparent thereto. The features and advantages described herein are not exhaustive, and in particular, many additional features and advantages will be apparent to those skilled in the art from the accompanying drawings and description. Moreover, no particular embodiment need have all the advantages listed herein, and it is expressly intended that individual advantageous embodiments be claimed separately. Furthermore, it should be noted that the language used in the specification has been chosen primarily for readability and guidance purposes, and therefore does not limit the scope of the subject matter of the invention. Attached Figure Description

[0088] Figure 1 This is an illustration of a DCM environment including a DCM and a medical device, according to an exemplary embodiment of the present disclosure.

[0089] Figure 2 This is another illustration of a DCM environment according to an exemplary embodiment of the present disclosure.

[0090] Figure 3 According to exemplary embodiments of this disclosure Figure 1 and Figure 2 A diagram of an example DCM.

[0091] Figure 4 This is an illustration of an example proprietary communication network hosted by multiple DCMs according to an example embodiment of this disclosure.

[0092] Figure 5 This illustrates when the DCM is activated according to an example embodiment of this disclosure. Figure 4 A data flow diagram of the message passing protocol for a proprietary communication network.

[0093] Figure 6 This illustrates an example embodiment of the present disclosure in the case of registration. Figure 5 A diagram of at least a portion of the configuration file that exists after the DCM is activated.

[0094] Figure 7 This illustrates an example embodiment of the present disclosure when the DCM is powered off. Figure 4 A data flow diagram of the message passing protocol for a proprietary communication network.

[0095] Figure 8 It is one of the exemplary embodiments according to this disclosure. Figure 4An illustration of an embodiment of a proprietary communication network used to track the use of disposable or consumable items in medical devices.

[0096] Figure 9 It is configured for patient fluid management according to an example embodiment of this disclosure. Figure 4 A diagram of a proprietary communication network.

[0097] Figure 10 This is a use of exemplary embodiments based on this disclosure. Figure 9 A flowchart of an example program that calculates fluid removal rate using a proprietary communication network.

[0098] Figure 11 It is configured to provide decision support for clinicians according to an example embodiment of this disclosure. Figures 1 to 3 A diagram of the DCM.

[0099] Figure 12 This illustrates an example embodiment according to the present disclosure. Figure 4 An illustration of how a proprietary communication network is used to provide notification messages to clinician devices.

[0100] Figure 13 This illustrates an example embodiment according to the present disclosure. Figures 1 to 3 How is the DCM configured to direct to Figure 12 An illustration of a clinical physician's device transmitting notification messages. Detailed Implementation

[0101] This document discloses methods, systems, and apparatus for hosting or otherwise providing proprietary wireless communication networks separate from medical networks. In one embodiment, these methods, systems, and apparatus are implemented via a digital communication module (“DCM”) such as a gateway. The example DCMs disclosed herein may be integrated into a medical device or provided separately from the medical device. In either configuration, the DCM is configured to receive medical device data from the medical device. The DCM transmits the medical device data to a hospital network for storage in patient records managed by an EMR server.

[0102] A sample DCM is provided via configuration files and / or configuration routines that specify input interface parameters, output interface parameters, device driver parameters, and / or data conversion parameters. The configuration files and / or configuration routines also define how the DCM communicates with other DCMs within the proprietary wireless communication network. DCMs within the same proprietary wireless communication network can form a mesh network, where the network is self-contained and hosted exclusively by the DCMs, without utilizing the hospital's network infrastructure.

[0103] The DCM is configured to operate with many different types of medical devices and communicates via various interfaces, such as serial connections (e.g., RS-232 or RS-485 connections), Ethernet connections, and Wi-Fi connections. The DCM can be connected via a Universal Serial Bus (“USB”) connection or any other wireless connection disclosed herein. Its configurability allows it to be used with many different types of medical devices, such as peritoneal dialysis machines, intensive care dialysis machines, continuous renal replacement therapy (“CRRT”) machines, hemodialysis machines, water preparation / purification devices, nutrient synthesis machines, infusion pumps, etc. Furthermore, the DCM's configurability allows it to be used within hospital systems with varying configurations. Therefore, the DCM's configurability enables the transmission of medical device data to a medical network without requiring modifications to the medical device or hospital system's connectivity or network.

[0104] This document references medical device data. As disclosed herein, medical device data is generated at the medical device and transmitted to the DCM. The medical device data includes treatment planning information. Treatment planning information includes one or more parameters that define how the medical device operates to administer treatment to the patient. For CRRT treatment, these parameters may specify the flow rate of fresh dialysis fluid, the total flow rate of dialysis fluid (or volume per bag), the dialysis fluid concentration of one or more substances, the desired dialysis dose, particularly in terms of flow rate (such as waste fluid flow rate, urea clearance rate, etc.), the total number of fresh dialysis bags connected to the CRRT medical device, the target UF removal, the blood flow rate, the total number of connected discharge bags, blood filter or dialyzer information, the replacement fluid volume and / or flow rate, and / or the amount (and / or rate) of heparin or other drugs / additives to be added to the patient's recirculated blood.

[0105] For peritoneal dialysis treatment, this parameter can specify the volume (or rate) of fresh dialysis fluid to be pumped into the patient's peritoneal cavity, the amount of time the fluid will remain in the patient's peritoneal cavity (i.e., residence time), and the volume (or rate) of used dialysis fluid and ultrafiltration (“UF”) to be pumped or drained from the patient after the residence period expires. For treatments with multiple cycles, this parameter can specify the fill volume, residence volume, and drain volume for each cycle, as well as the total number of cycles to be performed during the treatment process (where one treatment is provided daily, or separate treatments are provided during the day and night). Additionally, the parameter can specify the date / time / day (e.g., a schedule) on which the medical fluid delivery machine will administer the treatment. Furthermore, the parameters for the prescribed treatment can specify the total volume of dialysate to be administered for each treatment, in addition to the concentration level of the dialysis fluid, such as blood glucose levels. For infusion treatments, this parameter may include the volume to be infused, the drug to be infused, the drug concentration, the drug dose, and / or the infusion rate.

[0106] Medical device data also includes event information related to the administration of treatment. Event information may include data on measured, detected, or determined parameter values ​​generated by the medical device. For example, while a prescribed treatment may specify five separate cycles, each with a residence time of forty-five minutes, a medical fluid delivery device may administer treatment with fewer cycles, each with a residence time of thirty minutes. The medical device monitors how treatment is administered and provides parameters indicating the operation accordingly. Parameters used for treatment data may include, for example, the total amount of dialysis fluid administered to the patient, blood flow rate, dialysis fluid flow rate, dialysis dose, replacement fluid flow rate, used dialysis fluid for waste fluid flow rate, anticoagulant (e.g., citrate or heparin) flow rate, calcium flow rate, dialysis fluid temperature, intravenous drug flow rate, number of cycles performed, infusion volume per cycle, residence time per cycle, drainage time / volume per cycle, estimated amount of UF removed, treatment start time / date, and / or treatment end time / date. Treatment data can be prescribed or calculated, such as fill rate and discharge rate, which are determined by dividing the volume of fluid pumped by the time taken to pump. Treatment / event data may also include identification of warnings that occurred during treatment, duration of the warning, time of the warning, events associated with the warning, and / or indications of whether the problem that caused the warning was resolved or whether the warning was silenced.

[0107] Medical device data also includes the device's machine log, which contains diagnostic information, fault information, etc. Diagnostic information may include information indicating the internal operation of the medical device, such as faults related to pump operation, signal errors, communication errors, software problems, etc. Medical device data may be transmitted as a data stream or provided at periodic intervals. In some cases, medical device data may be transmitted as events or other changes in the data occur.

[0108] This document also references log data generated by the example DCM disclosed herein. The log data includes an identifier for the treatment device type, an identifier for the treatment device serial number, a timestamp indicating that treatment data was generated or received from the treatment device, an identifier for the DCM, a timestamp of the snapshot, and / or a DCM monotonic timestamp. I. DCM Environment Example

[0109] Figure 1 An illustration of a DCM environment 100 according to an exemplary embodiment of the present disclosure is shown. The exemplary DCM environment 100 includes at least one DCM 102 communicatively coupled to a medical device 104. The DCM 102 can be connected via a serial connection, Ethernet connection, USB connection, Wi-Fi connection, etc. The connection is made to the medical device 104. Example DCM 102 may include a network gateway, such as an IoT gateway.

[0110] In an example embodiment, DCM 102 is configured to receive medical device data from medical device 104. This unidirectional communication configuration prevents another device from accessing, programming, or otherwise communicating with medical device 104 via DCM 102. However, in some embodiments, DCM 102 may have a bidirectional communication link with medical device 104 to enable the transmission of data, planning instructions, or information to the medical device. Although in Figure 1 Only one DCM 102 and medical device 104 are shown in the diagram, but it should be understood that environment 100 may include dozens to hundreds or thousands of medical devices and corresponding DCMs forming a proprietary wireless communication network.

[0111] Example medical device 104 is configured to accept one or more parameters (i.e., treatment plan information) for a specified treatment or prescription. During operation, medical device 104 writes event, diagnostic, and / or operational data to one or more log files. In some embodiments, medical device 104 may periodically store medical device data to log files, such as every five to sixty seconds and / or after data changes. New medical device data written to the log files is transmitted to DCM 102. In some embodiments, the medical device creates medical device data in JavaScript Object Notation (“JSON”), Hypertext Markup Language (“HTML”) format, Extensible Markup Language (“XML”) format, Comma Separated Values ​​(“CSV”) format, text format, and / or Health-Level-7 (“HL7”) format.

[0112] The example medical device 104 may include one or more control interfaces 105 for displaying instructions and receiving control input from a user. The control interface 105 may include buttons, control panels, or a touchscreen. The control interface 105 may also be configured to allow the user to navigate to specific windows or user interfaces on the screen of the medical device 104. The control interface 105 may also provide instructions for operating or controlling the medical device 104.

[0113] The example medical device 104 also includes a processor or treatment module 107. The processor or treatment module 107 of the medical device 104 operates according to one or more instructions for performing treatment on a patient. These instructions can be obtained via a control interface 105. The processor or treatment module 107 also monitors for problems with equipment components, which are recorded as diagnostic information. The processor or treatment module 107 combines the operation of one or more pumps or other components to perform treatment to create medical device data. The processor or treatment module 107 transmits medical device data to a DCM 102.

[0114] The example DCM environment 100 also includes a medical network 106 that couples DCM 102 communications to an EMR server 108 and one or more hospital systems 110. The medical network 106 may include any number of gateways, routers, system hubs, switches, and / or network devices for establishing communication connections and routing data. The medical network 106 may include one or more firewalls that restrict access to authorized remote devices and / or servers only. The medical network 106 may include any local area network (“LAN”), wireless LAN (“WLAN”), Ethernet, Wi-Fi network, or a combination thereof.

[0115] like Figure 1 As shown, DCM 102 can be coupled to medical network 106 via wired or wireless means. In some embodiments, the connection may include an Ethernet connection, a Wi-Fi connection, and / or a cellular connection. Additionally or alternatively, DCM 102 may have a serial connection to EMR server 108 (or hospital system 110), which bypasses medical network 106.

[0116] Figure 2 Another illustration shows a DCM environment 100 according to an exemplary embodiment of the present disclosure. In this embodiment, a DCM 102 is included within and / or integrated with a medical device 104. The DCM 102 may include, for example, Digi The 6UL module features an NXP i.MX6UL-2 CPU, a Cortex-A7 528MHz CPU, and 256MB / 1GB NAND and DDR3 flash memory drives. The DCM 102 can be connected to the communication bus of the medical device 104 to receive data from the medical device. The DCM 102 (including...) Figure 1 The DCM also includes 802.11a / b / g / n / ac Wi-Fi radio and / or 4.2 Radio. The DCM 102 may include the Yocto Linux operating system and includes a driver for the Digi chipset.

[0117] Figure 1 and Figure 2Example EMR server 108 is configured to manage patient EMRs stored in a database on storage device 112. EMR server 108 is configured to receive medical device data, parse the data based on patient identifiers, locate the corresponding patient EMR in storage device 112, and store the parsed medical device data in the identified EMR. EMR server 108 can also access one or more EMRs in response to a request message identifying the corresponding patient. EMR server 108 can store medical device data in HL7 format, binary version 2 format, binary version 3 format, or Fast Medical Interoperability Resource (“FHIR”) format.

[0118] Example hospital system 100 may include any of the following: a service portal, an enterprise resource planning system, a web portal, a business intelligence portal, a HIPAA-compatible database, a pharmacy system, etc. Hospital system 100 may also include a middleware system and / or an integration engine. Hospital system 100 enables user devices (e.g., smartphones, laptops, workstations, tablets, etc.) to read and / or write medical device data stored in the EMR of memory device 112.

[0119] In the example shown, medical device 104 is a PrisMax manufactured by Baxter International. TM CRRT machine. It should be understood that in other embodiments, medical device 104 may include any other renal failure treatment machine, infusion pump, physiological sensor, etc. Medical device 104 may include, for example, infusion pumps (e.g., syringe pumps, linear peristaltic pumps, high-volume pumps (“LVP”), non-stationary pumps, multichannel pumps), nutrient synthesizers, oxygen sensors, respiratory monitors, blood glucose meters, blood pressure monitors, electrocardiogram (“ECG”) monitors, scales, and / or heart rate monitors.

[0120] Regarding treatment for kidney failure, the kidneys may fail due to various reasons. Kidney failure causes several physiological disturbances. For example, patients experiencing kidney failure are no longer able to balance water and minerals or excrete the daily metabolic load. Toxic end products of nitrogen metabolism (urea, creatinine, uric acid, etc.) can accumulate in the patient's blood and tissues. Kidney failure and decreased kidney function are treated with dialysis. Dialysis removes waste products, toxins, and excess water from the body that would otherwise be removed by normally functioning kidneys. Dialysis treatment, used to replace kidney function, is crucial for many people because this treatment is life-saving.

[0121] One type of treatment for kidney failure is hemodialysis (“HD”), which typically uses diffusion to remove waste products from a patient’s blood. A diffusion gradient travels between the blood and an electrolyte solution called dialysate or dialysate fluid through a semi-permeabilizer to induce diffusion.

[0122] Hemofiltration (“HF”) is an alternative kidney replacement therapy that relies on the convective transport of toxins from the patient’s blood. HF is achieved by adding replacement or replacement fluid (typically ten to ninety liters) to the extracorporeal circuit during treatment. During HF treatment, the replacement fluid and the fluid accumulated by the patient between treatments are ultrafiltered to provide a convective transport mechanism, which is particularly beneficial in removing medium and large molecules (in hemodialysis, small amounts of waste are removed along with the fluid acquired between dialysis treatment steps; however, the solute drag from the ultrafiltrate is insufficient to provide convective clearance).

[0123] Hemodialysis filtration (“HDF”) is a form of treatment that combines convective and diffusion clearance. HDF uses dialysate flowing through the dialyzer, similar to standard hemodialysis, to provide diffusion clearance. Additionally, a replacement solution is provided directly to the extracorporeal circuit to provide convective clearance.

[0124] Another type of treatment for kidney failure is peritoneal dialysis, which involves infusing a dialysis solution, also known as dialysis fluid, into the patient's peritoneal cavity. The dialysis fluid comes into contact with the peritoneum of the peritoneal cavity. Due to diffusion and osmosis (i.e., the formation of a transmembrane osmotic gradient), waste, toxins, and excess water flow from the patient's bloodstream through the peritoneum into the dialysis fluid. The osmotic agent in dialysis provides the osmotic gradient. Used or waste dialysis fluid is drained from the patient, removing waste, toxins, and excess water from the patient's body. This cycle is repeated, for example, multiple times.

[0125] Various types of peritoneal dialysis treatments exist, including continuous ambulatory peritoneal dialysis (“CAPD”), automated peritoneal dialysis (“APD”), tidal flow dialysis, and continuous flow peritoneal dialysis (“CFPD”). CAPD is a manual dialysis treatment. Here, the patient manually connects the implanted catheter to the drain outlet to allow used or waste dialysate fluid to drain from the peritoneal cavity. The patient then connects the catheter to a bag of fresh dialysate fluid to infuse fresh dialysate fluid into the patient's body through the catheter. The patient disconnects the catheter from the bag of fresh dialysate fluid, allowing the dialysate fluid to remain in the peritoneal cavity, where waste, toxins, and excess water are transferred. After the retention period, the patient repeats the manual dialysis procedure, for example, four times a day, with each treatment lasting approximately one hour. Manual peritoneal dialysis requires a significant amount of time and effort from the patient, leaving ample room for improvement.

[0126] Automated peritoneal dialysis (“APD”) is similar to CAPD in that dialysis treatment includes drainage, filling, and retention cycles. However, APD machines typically perform cycles automatically while the patient is asleep. APD machines eliminate the need for patients to manually perform treatment cycles and transport supplies during the day. An APD machine is fluidly connected to an implanted catheter, a source or bag of fresh dialysis fluid, and a fluid drain outlet. The APD machine pumps fresh dialysis fluid from the source through the catheter into the patient's peritoneal cavity. The APD machine also allows dialysis fluid to remain in the cavity and allows for the transfer of waste, toxins, and excess water. The source may include multiple sterile dialysis fluid bags.

[0127] The APD machine pumps used or waste dialysate from the peritoneal cavity through a catheter to the drain. Similar to the manual process, several cycles of draining, filling, and retention occur during dialysis. "Final filling" occurs at the end of the APD and remains in the patient's peritoneal cavity until the next treatment.

[0128] This system and associated methods are applicable to any of the above-mentioned forms of renal failure treatment. II. DCM Example

[0129] Figure 3 An example embodiment according to this disclosure is shown. Figure 1 and Figure 2 An illustration of an example DCM 102 is provided. The example DCM 102 includes a data manager 302 and an input interface 304 for communicatively coupling with a medical device 104. The input interface 304 may include at least one of a serial input port, an Ethernet port, and / or a wireless input port. The input interface 304 may include a wired or wireless transceiver for communicating with the medical device 104. In some embodiments where the DCM 102 is integrated within the medical device 104, the input interface 304 may be connected to a data bus or output connector on the PCB board of the medical device 104.

[0130] Input interface 304 is configured to receive medical device data 303 from the medical device, which is routed to data manager 302. In some embodiments, as described below, input interface 304 may also be configured to transmit information for display on the screen or control interface 105 of medical device 104. Additionally or alternatively, input interface 304 may transmit instructions for changing treatment parameters or treatment controls provided by treatment module 107 of medical device 104.

[0131] Example data manager 302 is configured to route medical device data 302 to the appropriate port of output interface 306. This routing depends on the configuration of DCM 102. For example, output interface 306 includes medical network interface 310, where medical device data 303 will be routed to EMR server 108 via medical network 106. Medical network interface 310 may include wired and / or wireless Ethernet transceivers, Wi-Fi transceivers, and / or serial transceivers for RS-232 or RS-485 connections to medical network 106. Data manager 302 is configured to select medical network interface 310 when medical device data 303 will be routed directly to EMR server 108 rather than via a proprietary communications network through another DCM 102A.

[0132] Example output interface 306 includes a proprietary network interface 312 for routing medical device data 303 to other DCM102As over a proprietary communications network. The proprietary network interface 312 may include a transceiver configured to... Reticulate Low power 5.0 It communicates with at least one of LoRa and / or LoRa. The proprietary network interface 312 is configured to initiate DCMs within communication range of each other to form a communication network with... Figure 1 and Figure 2 The illustrated medical network 106 is a separate proprietary communication network. When conditions and / or configuration indicate that data will be transmitted to another medical device / DCM 102A, the data manager 302 selects the proprietary network interface 312 for the transmission of medical device data 303, as will be discussed below at least in conjunction with... Figures 4 to 11 Let's discuss this in more detail.

[0133] In some embodiments, example output interface 306 includes a clinician device interface 314 that enables medical device data 303 (and / or notifications from notification processor 316) to be transmitted to clinician device 322. Clinician device interface 314 may include components configured for transmission via… Reticulate Low power 5.0 And / or a transceiver that communicates with at least one of any other wireless protocols (or hardware accessories such as transceivers with USB or lighting port interfaces) supported by the clinician device 322. Data manager 302 selects the clinician device interface 314 for medical device data 303 and / or notifications from the clinician device 322d.

[0134] If communication with the clinician device is desired, but a proprietary communication network with other DCMs 102A is provided via a wireless network protocol not supported by the clinician device, then output interface 306 includes clinician device interface 314. In this arrangement, data manager 302 uses proprietary network interface 312 for communication between DCMs 102A on the proprietary communication network, while providing communication with clinician device 322 via clinician device interface 314. In some embodiments, clinician device interface 314 is omitted if DCM 102 does not support or requires communication with clinician device 322. Additionally, clinician device interface 314 is omitted if communication with the clinician device can occur via proprietary network interface 312. For example, the proprietary communication network can implement a proprietary communication network supported by the known clinician device 322. Protocol. In this configuration, the clinician device 322 is part of a proprietary communications network hosted by the DCM 102 and other DCM 102As.

[0135] As mentioned above, Figure 3 The DCM 102 includes a notification processor 316, which is communicatively coupled to the data manager and the database 324. An example notification processor 316 is configured to generate event and / or warning notifications for the clinician device 322. The example notification processor 316 compares medical device data 303 received from the medical device 104 with one or more criteria stored in the database 324. If at least one criterion matches, the notification processor 316 creates a notification message for the appropriate clinician device 322. As described in more detail below, the clinician can use the clinician device 322 to access the notification processor 316, which may include one or more APIs to a template notification table in the database 324. The template notification table includes options for selecting criteria for receiving notification messages. Criteria may include, for example, patient identifiers, event conditions (such as low discharge bag, medical device pause), warning conditions (such as tubing blockage), and / or alarm conditions (such as treatment completion or a downward trend in UF removal). The criteria may also include options for selecting medical device data 303 for transmission to clinician device 322 (such as dialysis parameters) and / or how much background information is needed for display in conjunction with warnings / alarms / event notifications. The selection criteria via a template causes notification processor 316 to create logic, conditions, and / or thresholds for comparison with medical device data 303. The logic, conditions, and / or thresholds are stored in a criteria file in database 324 and associated with the destination network address, hardware address, and / or identifier of clinician device 322. After the criteria file is created, the notification processor accesses the file in database 324 to determine when to generate a notification message and the information to be included in the message.

[0136] Example DCM 102 also includes a file configuration manager 330, which enables the specification of routing for medical device data 303. The file configuration manager 330 stores at least one configuration file 332. In some embodiments, the file configuration manager 330 receives the configuration file 332 from a computer connected to the medical network 106 via a medical network interface 310 and / or from other DCMs 102A via a proprietary network interface 312.

[0137] Configuration manager 330 reads configuration file 332 and configures log manager 334, medical device manager 336, notification processor 316, data manager 302, and / or output interface 306 accordingly. For log manager 334, this may include reading configuration file 332 containing DCM identifier, medical device type, medical device identifier, etc., and writing this information to registers, parameters, and / or variables of log manager 334.

[0138] For data manager 302 and output interface 306, this may include reading configuration file 330 to determine which network interfaces 310 to 314 will receive medical device data 303. In one example, configuration file 332 may specify that medical device data 303 will be routed to medical network interface 310, because, for example, DCM 102 is designated as a node gateway or node for routing medical device data to EMR server 108. In another example, configuration file 332 may specify that medical device data 303 will be routed to private network interface 312, because another DCM 102A is a node gateway. In this example, configuration file 332 may include the identifier, network address, and / or hardware address of the receiving DCM 102A. In these examples, configuration file manager 330 may determine which of the other DCMs 102A will receive medical device data 303 based on a specified order, which may correspond to the activation date / time or robustness of the connection to medical network 106. Log manager 334 can determine the date / time when DCM 102 is activated or otherwise turned on (or medical device 104 is activated), and this date / time is stored in configuration file 332 so that configuration file manager 330 can determine which network interface 310 or 312 will receive medical device data 303.

[0139] In these examples, the configuration file manager 330 is configured to at least partially host the proprietary network interface 312. The configuration file manager 330 can specify conditions for connecting DCM 102 to other DCMs 102A in the proprietary communication network via parameters in the configuration file 332, including node identification broadcast messages, handshake messages, cross-network configuration messages, deactivation messages, and / or specifying parameters such as specifying node gateways, message timeout durations, network failover conditions, and networking protocols for transmission / reception channels / frequency / sub-frequency and / or data rates. The information in the configuration file 332 specifies the parameters and protocols of the proprietary communication network established and hosted by DCM 102 and other DCMs 102A.

[0140] In some examples, configuration file manager 330 can also specify the conversion file types used for network interfaces 310 to 314. Furthermore, configuration file manager 330 configures data manager 302 based on the duration between snapshots, the type of medical device data to be included in separate streams and / or subsets, and / or the type of data received from medical device 104 (e.g., JSON data, HTML data, binary data, HL7 data, XML data, etc.). Configuration file manager 330 also reads configuration file 332 to specify network certificates, authentication information, encryption keys, API identifiers, destination IP addresses, etc., for network interfaces 310 to 314.

[0141] Figure 3 The example log manager 334 creates and / or manages log data. As disclosed herein, the log data may include information indicating the medical device 104, such as an identifier of the medical device type, an identifier of the medical device serial number, a timestamp of the medical device data 303 generated from or received from the medical device 104, an identifier of the DCM 102, a timestamp of a snapshot (disclosed below) created by the device data manager 302, and a monotonic timestamp. The identifier of the medical device type, the identifier of the medical device serial number, and the identifier of the DCM 102 may be specified in a configuration file 332. In some cases, the identifier of the medical device type and the identifier of the medical device serial number may be reported by the medical device 104. The log manager 334 is configured to store this information and create appropriate timestamps when the medical device data 303 is received and / or when a snapshot is created. The log manager 334 may then transfer at least some of the log data to the data manager 302 for inclusion with the medical device data 303 routed to designated interfaces 310 to 314.

[0142] In some embodiments, the example data manager 302 is configured to create snapshots of medical device data 303 at discrete points in time, rather than processing / transmitting a continuous stream of medical device data. The time periods can be specified by configuration file 332 and include, for example, five-second intervals, ten-second intervals, thirty-second intervals, sixty-second intervals, etc. For each snapshot, the data manager 302 reads the most recently received data from the medical device 104. In this way, the data manager 302 provides periodic updates on the state of the medical device 104.

[0143] In one example, medical device 104 may transmit medical device data 303 in a continuous stream, at periodic intervals, or after data changes. Medical device 104 may transmit medical device data 303 in a medical device log file or a stream of messages. Data manager 302 compiles data received since the last snapshot interval. When the next interval approaches, data manager 302 compiles the most recent data into the snapshot to provide a representation of medical device 104 at that point in time. If multiple events occur during the compilation period, data manager 302 may include only the most recent event or all events that occurred during that time period.

[0144] In some examples, data manager 302 can compare the current snapshot with previous snapshots. Based on this comparison, data manager 302 can include only medical device data that has changed in the current snapshot since the previous snapshot. This comparison reduces the amount of data transmitted in each snapshot, allowing only new and / or updated medical device data 303 to be communicated. For example, CRRT medical device 104 can continuously transmit estimated UF removal values, delivered dialysis fluid, delivered replacement fluid, and / or removed waste fluid. Therefore, when there is a change in that value, data manager 302 only includes the UF removal value. In another example, a warning may be activated at a specific time. Device status can be included in medical device data 303 indicating that the warning is still active. However, data manager 302 only includes notification of the time the warning was activated (and the warning type) and the time the warning was silenced or reset in a second subsequent snapshot in the first snapshot, without including indication that the warning was active in intermediate snapshots.

[0145] In other embodiments, medical device 104 may selectively transmit only medical device data that has changed from previous values ​​or reflects new events. In such cases, data manager 302 writes the received medical device data 303 to an appropriate snapshot.

[0146] Data Manager 302 is configured to format any log data combined with medical device data 303 into a data format compatible with or required by EMR Server 108, other DCM 102A, and / or Clinician Device 322. In other words, Data Manager 302 creates transformations of medical device data 303 and / or log data. The transformation type can be specified by configuration file 332. This transformation can be, for example, from JSON to HL7, binary, and / or FHIR. Data Manager 302 may include one or more files and / or algorithms that specify how medical data 303 and / or log data in formats such as JSON, XML, HTTP, or HTML will be transformed into HL7, binary v2, binary v3, and / or FHIR. Files and / or algorithms can identify JSON data by location, data tags, field names, and / or metadata, and specify how the data will be transformed, including transformations of data tag names, metadata names, number formats, locations, etc. Data Manager 302 then transfers the transformed data to designated interfaces 310 to 314.

[0147] In some embodiments, DCM 102 is capable of bidirectional communication with medical device 104. An example medical device manager 336 of DCM 102 is configured to process data and / or information for transmission to medical device 104. Medical device manager 336 includes, for example, a mailbox 340 that allows external data or information to be written to DCM 102 for transmission to medical device 104. In other words, data from EMR server 108 (or other DCM 102A) is not written directly to medical device 104. Instead, data is written to or transmitted to mailbox 340. Example medical device manager 336 processes information in mailbox 340 to determine which data or information to transmit to medical device 104. In some embodiments, mailbox 340 and / or the criteria used for transmission to medical device 104 are stored in database 324.

[0148] In one embodiment, the medical device manager 336 receives sensor data or laboratory data related to a patient being treated by the medical device 104 from the EMR server 108. In some embodiments, the EMR server 108 may transmit the data to the medical network interface 310. In other embodiments, data is received in the DCM 102 from other DCMs 102A on a proprietary communication network (one of which is connected to the EMR server 108 via the medical network 106). This data is transmitted to a mailbox 340. The medical device manager 336 compares the received data with criteria specified in the database 324. In one example, the medical device manager 336 determines that the received data meets the criteria used to transmit the data itself to the medical device. Therefore, the medical device manager 336 converts the data into an appropriate format and transmits it via the input interface 304 to the treatment module 107 of the medical device 104, which causes the treatment module 107 to display the data on the control interface 105. In other examples, the medical device manager 336 compares the received data (including any relevant medical device data 303) with one or more conditions specified in the database 324 to determine recommendations for the medical device. The medical device manager 336 transmits one or more messages with recommendations to the medical device 104 for display. These recommendations may specify suggested changes to dialysis treatment, such as increasing residence time or changing the blood glucose concentration of the dialysis fluid. In other examples, the medical device manager 336 uses received data (including any relevant medical device data 303) and one or more conditions specified in the database 324 to determine treatment adjustments. The medical device manager 336 transmits one or more messages with treatment adjustments to the treatment module 107 of the medical device to change or modify current or future treatment (such as switching from non-tidal treatment to tidal treatment, increasing fill, residence, or drain time, increasing / decreasing fluid removal rate, etc.).

[0149] In the following sections, reference is made to the operations performed by components 302, 304, 306, 310, 312, 314, 316, 330, 334, and 336 of the DCM 102. The example operations performed by components 302, 304, 306, 310, 312, 314, 316, 330, 334, and 336 of the DCM 102 can be implemented using one or more computer programs and / or application software. The program or application software can be defined by a set of computer instructions stored on any computer-readable medium, including random access memory (“RAM”), read-only memory (“ROM”), flash memory, magnetic disk or optical disk, optical storage, or other storage media. These instructions can be configured to be executed by the processor of the DCM 102, and when executed, they perform or facilitate the execution of all or part of the methods and programs disclosed herein. The permanent storage device or database 324 may include any memory device, including RAM, ROM, flash memory, etc. III. Example of a proprietary communication network implementation

[0150] As mentioned above, Figures 1 to 3 Example DCM 102 is configured to be hosted or otherwise participate in a proprietary communications network separate from the medical network. Figure 4 An illustration is shown of an example proprietary communication network 400 hosted by multiple DCMs according to an exemplary embodiment of this disclosure. In the illustrated diagram, reference is made only to DCM 102, wherein each DCM is connected to a respective medical device 104 (i.e., CRRT machine).

[0151] like Figure 4 As shown, the proprietary communication network 400 formed by DCMs 102 includes a mesh network, wherein each DCM 102 can wirelessly communicate with other DCMs within range. Any DCM outside range can connect to the network 400 via at least one other DCM. In other examples, the DCMs 102 may arrange themselves to communicate in an ordered sequence, such that each DCM acts as a router or switch between other DCMs.

[0152] In the illustrated embodiment, DCM 102 shares the same proprietary communication network 400 protocol and is able to include additional DCMs when they are online and within range of network 400. Figure 4A DCM 102A-1 is shown, designated as a node gateway, providing a primary interface (via its medical network interface 310) to the EMR server 108 via the medical network 106. In this configuration, other DCMs 102A-2 through 102A-6 transmit medical device data 303 to DCM 102A-1 for transmission to the EMR server 108. Gateway node DCM 102A-1 provides a single point of access for other DCMs 102A-2 through 102A-6, reducing the number of ports required to connect to the medical network 106. This reduces configuration time when each DCM 102 comes online because no network certificate installation is required. Conversely, if a new DCM comes online as part of a protocol for a proprietary communications network 400, DCM 102 can share the network certificate with the new DCM. The illustrated configuration also enhances security by restricting network access to DCMs 102A-2 through 102A-6.

[0153] Figure 5 A data flow diagram 500 according to an example embodiment of this disclosure is shown, indicating the messaging protocol of the proprietary communication network 400 when DCM 102 is activated. In the illustrated embodiment, DCMs 102A-1 and 102A-2 initially host the proprietary communication network 400. Furthermore, 102A-1 is designated as the host gateway communicating with the EMR server 108. In this example, the host gateway is determined based on which DCM 102 was activated earliest. In other examples, the host gateway may be determined based on which DCM 102 has a more robust communication connection to the EMR server 108, which DCM 102 is connected to the most other DCMs, or any other arrangement specified by the protocol of the proprietary communication network 400.

[0154] In this example, DCM 102A-3 comes online or is activated. Its activation can occur when its corresponding medical device 104 is powered on for treatment. Upon power-on, DCM 102A-3 (via profile manager 330) broadcasts a wake-up message 502 on the proprietary communication network 400. Wake-up message 502 may include an identifier for DCM 102A-3. Wake-up message 502 may also include a request for an acknowledgment message. In other examples, DCMs 102A-1 and 102A-2 (via profile manager 330) are configured to automatically transmit a response message 504 to wake-up message 502. Response message 504 may include the address and / or identifier of the respective DCMs 102A-1 and 102A-2. This initial handshake provides DCM 102 with indication of which other DCMs are within wireless communication range of each other.

[0155] Subsequently, using the identifier or address provided in response message 504, example DCM 102A-3 can transmit registration message 506 to each of DCMs 102A-1 and 102A-2 respectively. In other examples, DCM 102A-3 can broadcast registration message 506. Registration message 506 includes the address and / or identifier of DCM 102A-3, and may include network authentication information that ensures only DCMs (or medical devices) of a specific manufacturer can form or connect to the proprietary communications network 400. Registration information 506 also includes date / time information (via log manager 334) indicating when DCM 102A-3 was powered on or activated.

[0156] If necessary, DCMs 102A-1 and 102A-2 authenticate DCM 102A-3 and record the registration information in their respective configuration files 332. DCMs 102A-1 and 102A-2 can also retransmit the registration information to other DCMs in network 400 to ensure that any DCM outside the coverage area receives the registration information. If registration is successful, DCMs 102A-1 and 102A-2 (including any DCM outside the coverage area) each transmit a registration response message 508. Example message 508 indicates successful registration and that DCM 102A-3 is part of network 400. Response message 508 may also include the date / time each of DCMs 102A-1 and 102A-2 was opened and / or other information from their respective configuration files 332, such as the activation time of other DCMs, the settings of medical network 106, etc.

[0157] Figure 6 At least a portion of a configuration file 332 is shown after a DCM 102A-3 according to an example embodiment of this disclosure has been registered. Configuration file 332 shows the date / time on which each DCM is activated, turned on, or otherwise powered. It should be understood that each DCM 102 includes... Figure 6 This is a portion of configuration file 332 shown. This allows DCM 102 to independently determine the node gateway based on protocol rules without relying on the master DCM. In the illustrated embodiment, DCM 102A-1 has the earliest date / time and is designated as the node gateway by each DCM 102, as... Figure 4 As shown.

[0158] return Figure 5After registration, DCM 102 periodically (e.g., every second, five seconds, ten seconds, thirty seconds, one minute, etc.) broadcasts a heartbeat message 510 (for simplicity, heartbeat messages from DCM 102A-1 are not shown). The heartbeat message 510 may include the DCM's identifier and indicate that DCM 102 is still the active node on network 400. If DCM 102 does not receive a heartbeat message within a specified time limit, DCM 102 may broadcast a ping message for the lost DCM or specify that the lost DCM is disconnected (by removing its date / time activation information). It should be understood that, in conjunction with... Figure 5 The communication discussed occurs through the proprietary network interface 312 of each DCM 102.

[0159] Figure 5 It is also shown that, since DCM 102A-1 is a node gateway, DCMs 102A-2 and 102A-3 transmit their medical device data 303 to DCM 102A-1. DCM 102A-1 then co-transmits the received medical device data 303 to EMR server 108 (via medical network interface 310). In some embodiments, as part of a proprietary protocol, DCM 102 can coordinate the recording / transmission of snapshots of medical device data. In one example, DCMs can record snapshots at different offsets, making the data transmission to node gateway DCM 102 tapered (thus reducing transmission bottlenecks due to network bandwidth limitations). This allows node gateway DCM 102 to extend the transmission of medical device data 303 to EMR server 108 over time.

[0160] Figure 7A data flow diagram 700 illustrating the messaging protocol of a proprietary communication network 400 when DCM 102 is powered down, according to an example embodiment of this disclosure, is shown. In the illustrated embodiment, node gateway DCM 102A-1 is deactivated and / or its corresponding medical device 104 is powered down or deactivated. Before DCM 102A-1 is powered down, it transmits or broadcasts a deactivation message 702, which may include an identifier of DCM 102A-1. The deactivation message 702 indicates that DCM 102A-1 will be offline (and unavailable as a node gateway). In some embodiments, DCMs 102A-2 and 102A-3 transmit a response message 704 indicating receipt of the deactivation message 702. The response message can also be used to replay the deactivation information to other DCMs outside the communication range of DCM 102A-1. After receiving at least one response message 704, DCM 102A-1 is powered down. Additionally, other DCMs 102A-2 and 102A-3 update their configuration file 332 to remove entries for DCM 102A-1 or otherwise indicate that DCM 102A-1 is not active.

[0161] Using protocol rules, DCM 102 independently determines that DCM 102A-2 is now the node gateway. The configuration file manager 330 of DCM 102A-2 can restart its medical network interface 310 to communicate with EMS server 108. In some embodiments, this may include DCM 102A-2 transmitting an activation message indicating to EMS server 108 that DCM 102A-2 is the node gateway. In other examples, because DCM 102 can share network settings (including destination IP addresses), switching to DCM 102A-2 is seamless, as it can use the network settings to communicate seamlessly with EMS server 108 instead of DCM 102A-1. In some examples, DCM 102A-2 may transmit acknowledgment messages via proprietary network interface 312 to other DCM 102A-3, indicating that DCM 102A-2 is available as a node gateway. At this time, DCM 102 broadcasts heartbeat messages 510 at periodic intervals. In order to transmit data, DCM 102A-3 transmits medical device data 303 to DCM 102A-2, and then DCM 102A-2 transmits the received medical device data 303 and its medical device data 303 to EMR server 108 at a specified time (or snapshot interval). IV. Example one-time Supplies / Consumables Tracking Implementation Examples

[0162] As described above, the proprietary communication network 400 hosted via DCM 102 enables features that may not be supported by the medical network 106 and / or EMR server 108. Figure 8 The illustration shows an example embodiment of the present disclosure, in which a proprietary communication network 400 is used to track the use of medical devices for disposable items or consumables in a medical facility or patient's home 800.

[0163] In some embodiments, the log manager 334 of the DCM 102 is configured to analyze medical device data 303 to obtain information on disposable supplies / consumables. The log manager 334 maintains log files in a database 324 that track the use of disposable supplies / consumables. The log manager 334 can track the use and / or replacement of filters, cartridges, tubing sets, dialysis solutions, saline solutions, renal replacement solutions, warming bags, and / or disposable sensors. The medical device 104 may include usage information as event information including medical device data. For example, the medical device may detect or determine each time a solution bag is replaced, a sensor is replaced, etc. In some cases, some consumables / disposable supplies may be replaced after each treatment or after a specific number of treatments.

[0164] DCM 102 can communicate their consumable / disposable item usage information with each other. In this configuration, each DCM 102 maintains a fleet total for all medical devices as part of network 400. Node gateway DCM 102 can periodically transmit messages to EMR server 108 or hospital inventory management server via medical network 106, causing consumables / disposable items to be reordered as estimated quantities decrease. Therefore, if node gateway DCM 102 goes offline, the next DCM 102 also has the fleet total. In other embodiments, only designated DCMs, such as node gateway DCM 102, maintain the fleet total quantity.

[0165] In some embodiments, DCM 102 is configured to manage inventory replenishment via profile manager 330. In these embodiments, DCM 102 receives an indication of available inventory. This indication may be entered into at least one medical device or received from a server via medical network interface 310. In some cases, medical network interface 310 may be configured to communicate with a wide area network such as the Internet to provide inventory tracking with the vendor.

[0166] like Figure 8As shown, DCM 102 tracks the use of consumables / disposable supplies for each corresponding medical device. For example, DCM 102A-1 determines that a corresponding CRRT 1 has consumed two M100 filter assemblies, five dialysis solution bags, and two replacement solution bags. The DCM uses a proprietary communication network 400 to share and total the use of disposable supplies / consumables. The node gateway DCM 102 compares this total with automatically generated limits to determine when a replenishment message will be generated. In some embodiments, the node gateway and / or all DCMs 102 may track the consumption rate to estimate when inventory will fall below a threshold and generate a replenishment message accordingly. V. Example of patient fluid management implementation

[0167] In some embodiments, multiple medical devices 104 on the same proprietary communication network 400 (hosted by a corresponding DCM 102) can communicate with each other to facilitate medical treatment. In one example, an infusion pump and a dialysis machine can communicate for fluid management. Figure 9 An example embodiment of the present disclosure is shown configured for patient fluid management. Figure 4 A diagram of the proprietary communication network 400.

[0168] In the illustrated embodiment, the DCM 102A-0 of the CRRT medical device 104A-0 is part of a proprietary communication network 400 having three infusion pump medical devices 104A-1 to 104A-3 and corresponding DCMs 102A-1 to 102A-3. Figure 9 Other medical devices, which may also be part of the dedicated communication network 400, are omitted. The DCM 102 shown is determined via its respective configuration file manager 330 to be assigned to the same patient. In one example, the medical device 104 is programmed with a patient identifier as part of the treatment setup. Before treatment begins, the DCM 102 receives the patient identifier, identified by the log manager 334. Subsequently, the DCM 102 can broadcast the patient identifier and the corresponding device address and / or identifier to determine which other DCMs are associated with the same treatment. DCMs as part of the same treatment can share medical device data 303 with each other to facilitate treatment management provided by the medical device manager 336.

[0169] In the example shown, the clinician uses the control interface 105 of the CRRT medical device 104A-0 to input or program adaptive patient fluid removal, which includes fluid volume parameters and removal cycle parameters (e.g., 1000 ml of fluid is removed over 24 hours). The medical device manager 336 calculates the corresponding fluid removal rate and transmits this data to the CRRT medical device 104A-0.

[0170] During treatment, each DCM 102A-1 to 102A-3 receives medical device data 303 from its corresponding infusion pump medical device 104A-1 to 104A-3. Medical device data 303 includes the infusion rate transmitted from DCM 102A-1 to 102A-3 to DCM 102A-0 over a proprietary communication network 400. Infusion pump medical device 104A-1 can infuse a first fluid at a rate of 10 ml / h, while infusion pump medical device 104A-2 can infuse a second fluid at a rate of 20 ml / h, and infusion pump medical device 104A-3 can infuse a third fluid at a rate of 25 ml / h.

[0171] For example, medical device data can be broadcast along with the transmission of the DCM identifier, allowing DCM 102A-0 to determine, under protocol rules, that the destination of the broadcast transmission is its mailbox 340. In another example, DCMs 102A-1 through 102A-3 can transmit messages with the destination address or identifier of DCM 102A-0 to ensure that only DCM 102A-0 processes the received data. The medical device manager 336 of DCM 102A-0 receives the infusion rate, combines it with the dialysis infusion rate of CRRT medical device 104A-0, and determines a new target volume removal rate to meet specified parameters. The medical device manager 336 transmits the new fluid removal rate to CRRT medical device 104A-0, which can be displayed as a suggestion by control interface 105 or as a control command to treatment module 107 for changing the prescribed treatment. It should be understood that this configuration eliminates the need for clinicians to manually calculate fluid clearance rates based on medical device data from multiple medical devices. The above configuration also enables near real-time adjustment of the fluid removal rate to reflect any changes in the infusion rate.

[0172] Figure 10 This is for use according to an exemplary embodiment of the present invention. Figure 4 A flowchart of an example program 1000 for calculating fluid removal rates using a proprietary communication network 400. (Although referenced...) Figure 10 The flowchart shown illustrates procedure 1000, but it should be understood that many other methods can be used to perform the steps associated with procedure 1000. For example, the order of many boxes can be changed, some boxes can be combined with other boxes, and many of the boxes described can be optional. In one embodiment, the number of boxes can be varied. Furthermore, the steps of updating the infusion pump medical devices 104A-1 to 104A-3 and providing notification messages to clinicians can be omitted. The actions described in procedure 1000 are specified by one or more instructions and can be performed in multiple devices, including, for example, DCM 102A-0 and / or medical device 104A-0.

[0173] The example procedure 1000 begins when DCM 102A-0 (via Event Medical Device Data 303) receives an indication that a clinician has selected the fluid volume parameter for removal and the removal cycle parameter (and other parameters) for CRRT treatment. DCM 102A-0 also receives an indication that the clinician has selected an adaptive fluid removal feature (box 1004). The selection of the adaptive fluid removal feature causes DCM 102A-0 to transmit a broadcast message with its identifier and / or address to identify other medical devices also associated with the same patient (box 1006). In response to the broadcast message, DCMs 102A-1 to 102A-3 of infusion pump medical devices 104A-1 to 104A-3 transmit response messages indicating the same patient identifier and / or medical device type. In some cases, after receiving a response message, DCM 102A-0 transmits or broadcasts a message for DCMs 102A-1 to 102A-3 requesting the transmission of infusion rate medical device data 303. In other embodiments, the initial broadcast message may identify the required medical device data.

[0174] like Figure 10 As shown, DCMs 102A-1 to 102A-3 transmit messages with the destination address and / or identifier of DCM 102A-0, including infusion rate medical device data 303 (box 1008). DCM 102A-0 receives data 303 and adds it to the dialysis filling rate included in medical device data 303 from CRRT medical device 104A-0 to determine the total rate of fluid supplied to the patient (box 1010). DCM 102A-0 then compares the total fluid rate with adaptive fluid parameters to ensure that the fluid volume to be removed is met within a specified time period (box 1012). DCM 102A-0 uses this comparison to determine whether adjustments to the infusion therapy and / or CRRT therapy are needed (box 1014). This determination can be made by the medical device manager 336 of DCM 102A-0 to determine whether the fluid removal trend will meet the desired removal rate.

[0175] If no adjustment is required, DCM 102A-0 returns to box 1008, where it receives subsequent medical device data 303 (e.g., the next data snapshot). If adjustment is required, the medical device manager 336 of DCM 102A-0 determines a new fluid removal rate for CRRT medical device 104A-0 to meet fluid volume and time parameters (box 1016). DCM 102A-0 then transmits a message 1017 indicating the new fluid removal rate to CRRT medical device 104A-1. In some embodiments, CRRT medical device 104A-1 displays the removal rate as a treatment recommendation on control interface 105. In other embodiments, CRRT medical device 104A-1 routes message 1017 to treatment module 107 for updating CRRT treatment using the new fluid removal rate.

[0176] In some embodiments, DCM 102A-0 may also determine adjustments to one or more infusion rates (block 1018). In these embodiments, DCM 102A-0 transmits messages 1019 for appropriate DCMs 102A-1 to 102A-3 with modified infusion rates. Similarly, designated DCMs 102A-1 to 102A-3 display suggested or modified treatments.

[0177] Furthermore, in some embodiments, the notification processor 316 may generate a notification message 1021 (block 1020) indicating a change / recommendation in the fluid removal rate and / or a change / recommendation in the infusion pump rate. The DCM 102A-1 transmits the notification message 1021 to the designated clinician device 322 via the network 400 and / or via a separate wireless communication link via the clinician device interface 314. Figure 10 The example program 1000 continues by returning to box 1008 for a subsequent snapshot (or stream) of the medical device data 303. VI. Clinical physician decision support examples

[0178] In some embodiments, the DCM 102 (Medical Device Manager 336) is configured to analyze medical device data 303 from the connected medical device 104 by combining medical device data and / or laboratory results from devices outside the dedicated communications network. Conversely, medical device data from these other devices is stored in the patient's EMR via the EMR server 108 and is only available via the medical network 106. Figure 11 An illustration of a clinician decision support embodiment according to an example embodiment of the present disclosure is shown, wherein DCM 102 is configured to use medical device data received from EMR server 108 in part to provide decision support for a connected medical device 104.

[0179] Figure 11 This illustration shows an example embodiment of a device configured to provide decision support for clinicians, according to an example embodiment of this disclosure. Figures 1 to 3 A diagram of DCM 102 is shown. In the example shown, DCMs 102A-1 and 102A-2 are associated with CRRT medical devices 104A-1 and 104A-2. Each of DCMs 102A-1 and 102A-2 (e.g., respective medical network interfaces 310) is connected to EMR server 108 via medical network 106. Additionally, EMR server 108 is communicatively coupled to blood pressure monitor 1102, blood gas analyzer 1104, infusion delivery system 1106, and other devices 1108 via medical network 106. Other devices may include a laboratory server providing laboratory results, a pharmacy server providing prescription drugs, a weighing scale, a thermometer, a heart rate monitor, etc.

[0180] In the illustrated embodiment, the medical device managers 336 of DCMs 102A-1 and 102A-2 are configured to communicate bidirectionally with the EMR server 108. To receive data from the EMR server 108, the medical device manager 336 can determine the patient identifier of the patient connected to the corresponding CRRT medical device 104 or associated with it. The medical device manager 336 transmits a request message to the EMR server 108 via the medical network interface 310. This request message includes the patient identifier and the identifier and / or network address of DCM 102.

[0181] EMR server 108 identifies the patient's EMR record and the requested data. EMR server 108 then transmits the identified data to mailbox 340 of the requesting DCM 102. In some cases, a request from DCM 102 causes EMR server 108 to provide a data stream when data is received from the relevant device 1102 to 1108 within a specified duration and / or treatment period.

[0182] The example medical device manager 336 of DCM 102 is configured to combine data received from EMR server 108 with medical device data 303 received from the corresponding medical device 104. The medical device manager 336 can then apply one or more rules or criteria to the combined data.

[0183] In some embodiments, the one or more rules or criteria may specify that certain portions of the received data will be displayed at the medical device 104. The medical device manager 336 accordingly transmits the specified data to the treatment module 107 for display on the control interface 105 of the medical device 104. In other examples, the medical device manager 336 may store the specified data in a mailbox 340. In these other cases, the treatment module 107 may periodically poll the mailbox 340 to obtain the data to be displayed. In some cases, the medical device manager 336 may identify treatment suggestions or adjustments, wherein information indicating suggestions or adjustments is stored in the mailbox 340 and / or transmitted to the medical device 104 for display. In further embodiments, the medical device manager 336 may determine parameters and / or treatment adjustments based on comparisons with rules and / or criteria. In these embodiments, the medical device manager 336 transmits new parameter or adjustment information to the mailbox 340 or the treatment module 107 to alter the ongoing or subsequent treatment provided by the medical device 104.

[0184] In one example, DCM 102 may receive blood pressure data from EMR server 108 during CRRT treatment. In response, DCM 102 may determine, based on one or more rules and / or criteria stored in database 324, whether the stay or discharge phase of the CRRT treatment should be extended. DCM 102 may transmit a recommendation to increase the stay or discharge phase, or cause CRRT medical device 104 to increase the duration of the stay or discharge phase.

[0185] It should be understood that, in one embodiment, DCM 102 is an edge computing node in the medical network 106. For proprietary communication networks, multiple DCMs 102 are used as edge computing nodes, where at least some clinical decisions occur at the edge of the medical network 106 rather than at a central location, such as at EMR server 108. This configuration can reduce computing resources at EMR server 108 and prevent processing bottlenecks that might be common to central clinical support. VII. Clinical physician event notification example

[0186] As mentioned above, Figures 1 to 3 The DCM 102 includes a notification processor 316 for generating notification messages for the clinician device 322. Figure 12 An example embodiment of this disclosure is shown, illustrating the following regarding... Figure 4The illustration shows how the proprietary communication network 400 is used to provide notification messages to the clinician device 322. In the illustrated embodiment, the DCM 102 of the medical device 104 is configured to transmit notification messages to the registered clinician device 322. This is in the case where the clinician device 322 is able to connect to the proprietary communication network 400 via an interface (e.g., via...). The DCM 102 is configured to use its proprietary network interface 312 for transceivers. In cases where a separate connection to the clinician device 322 is required, the DCM 102 is configured to use the clinician device interface 314.

[0187] Figure 12 The configuration shown enables the clinician device 322 to receive notifications about the status of the connected medical device 104 without requiring the clinician to be physically present with the device. Status may include warnings, alarms, and / or events. Remote access to the medical device can be important when it is not feasible for clinicians to be at the patient's bedside for extended periods, such as in the treatment of highly infectious diseases like COVID-19. Furthermore, as... Figure 12 As shown, a single clinician device 322 can be used to simultaneously monitor, for example, nine different medical devices 102.

[0188] It should be understood that the disclosed embodiments enable personal mobile devices to receive medical notifications, even when the medical network 106 does not have such capability. Therefore, medical device manufacturers can provide remote monitoring and control for the clinician device 322 without affecting the medical network 106. This configuration provides an additional layer of security, eliminating potential security entry points into the network since the clinician device 322 never needs to connect to the medical network 106 for configuration or receiving notifications. Furthermore, access to network 400 and / or DCM 102 is local, preventing even remote malicious applications from reaching network 400 or the associated medical device.

[0189] During the registration phase (described below), clinicians access DCM 102 to complete a template form outlining which notifications they expect, including setting thresholds and / or conditions for when to generate notifications. For example, clinicians can complete the form to receive pressure warnings, empty bag warnings, filter condensation warnings, low fresh bag warnings, etc. The form also allows clinicians to prioritize when and / or which notifications to provide.

[0190] The example notification processor 316 of DCM 102 compares medical device data 303 with criteria specified by a clinician. When at least one criterion is met, the notification processor 316 creates a notification message (e.g., a text or SMS message or push notification) that is transmitted to clinician device 322 via clinician device interface 314 and / or proprietary network interface 312. In some cases, clinician device 322 may be outside the wireless range of at least one monitored medical device 104. To address this issue, the DCM of proprietary communication network 400 is configured to broadcast and rebroadcast notification messages to ensure that messages reach clinician device 322. Network 400 may have protocol rules regarding the number of times a notification is rebroadcast. Furthermore, in some embodiments, clinician device 322 may provide an acknowledgment message upon receiving a notification message to cause DCM 102 to stop broadcasting the notification.

[0191] Figure 13 This illustration shows how to configure DCM 102 to direct traffic to... (The sentence is incomplete and requires more context to translate accurately.) Figure 12 The illustration shows the transmission of notification messages by the clinician device 322. In the illustrated embodiment, the computer 1300 includes an application 1302 that enables the clinician to access and edit forms on a designated DCM 102. The computer 1300 can access the DCM 102 via a medical network interface 310 through a medical network 106. In this example, the application 1302 may include fields for an identifier or network address of the DCM 102 and / or the medical device 104. Input of the identifier or address enables the application 1302 to access the DCM 102 or transmit a request message for a notification form. Upon receiving the form, the application 1302 displays fields entered by the clinician regarding criteria and / or conditions for receiving notifications. The clinician may also provide an identifier for their clinician device 322 for subscribing to designated notifications.

[0192] In other embodiments, application 1302 may additionally include fields corresponding to the form at DCM 102. Clinicians complete these fields, including the DCM / medical device identifier, criteria / conditions, and target device. After completing these fields, the clinician causes application 1302 to transmit one or more messages containing data from these fields to, for example, an API at the desired DCM 102's notification processor 316 (or broadcasts the message, where only the designated DCM 102 processes the request), for storing the received information in a notification record stored in database 324.

[0193] In some embodiments, application 1302 can also configure clinician device 322. For example, application 1302 can provide instructions for pairing clinician device 322 with proprietary communication network 400 and / or designated DCM 102. In other examples, application 1302 causes notification messages to be transmitted to clinician device 322. The notification messages include links to scripts that, when selected at clinician device 322, automatically configure device 322 to connect to network 400 and / or designated DCM 102. After configuration, clinician device 322 is able to receive notification messages from DCM 102 regarding events, warnings, and / or alarms related to the corresponding medical device 104.

[0194] The aforementioned notification features provide benefits to clinicians using CRRT medical devices. Typically, CRRT medical devices have a specific number of fresh dialysis fluid bags and a specific number of drain bags. Instead of requiring clinicians to periodically check the bag status, DCM 102 transmits notifications when the fresh bags are nearly empty (e.g., within 15 to 20 minutes of draining). DCM 102 also uses specified criteria to transmit notifications when the drain bags are nearly full. Therefore, DCM 102 only provides clinician notifications via device 322 when attention to a specific medical device is needed, or even when the medical network may not support clinician device connectivity. VIII. in conclusion

[0195] It should be understood that various changes and modifications to the presently preferred embodiments described herein will be apparent to those skilled in the art. Such changes and modifications can be made without departing from the spirit and scope of the invention and without diminishing its advantages. Therefore, such changes and modifications are intended to be covered by the appended claims.

Claims

1. A digital communication module (102), comprising: - An input interface (304) is configured to be communicatively coupled to a medical device (104), the input interface (304) including at least one of a serial input port, an Ethernet input port and a wireless input port; - Output interface (306) is configured to be communicatively coupled to (i) an electronic medical record (EMR) server (108) via a medical network (106) and communicatively coupled to (ii) at least one other digital communication module (102A) via a wireless private network (400), said output interface (306) including at least one of a serial output port, an Ethernet output port or a wireless output port; - A file configuration manager (330) is configured to store at least one configuration file (332) having an identifier of the digital communication module (102); and - A data manager (302), communicatively coupled to the input interface (304), the output interface (306), and the file configuration manager (330), wherein the data manager (302) is configured to: Upon power-on, a wake-up message is transmitted via the wireless private network (400) to at least one other digital communication module (102A). The wake-up message includes the identifier of the digital communication module (102) and a date / time indication of power-on. The system receives a response message from each of the at least one other digital communication module (102A) via the wireless private network (400). The response message includes an identifier or network address of each other digital communication module (102A) and a date / time indication of when each other digital communication module (102A) is powered on. Receive medical device data (303) from the medical device (104). The medical device data (303) to be transmitted to the EMR server (108) via the first digital communication module (102A) having the earliest date / time indication, and The medical device data (303) is transmitted to the first digital communication module for transmission to the EMR server (108).

2. The digital communication module (102) according to claim 1, wherein, The data manager (302) is further configured to: Receive a power-off message from the first digital communication module indicating that the first digital communication module is no longer available; Remove the date / time indicator from the first digital communication module; Receive data (303) from the second medical device from the medical device (104). It is determined that the second medical device data (303) will be transmitted to the EMR server (108) via the second digital communication module (102A) which has the earliest date / time indication, wherein the date / time indication of the first digital communication module is removed; as well as The second medical device data (303) is transmitted to the second digital communication module for transmission to the EMR server (108).

3. The digital communication module (102) according to claim 1, wherein, The data manager (302) is further configured to: Receive a power-off message from the first digital communication module indicating that the first digital communication module is no longer available; Remove the date / time indicator from the first digital communication module; Receive data (303) from the second medical device from the medical device (104). Based on the fact that the digital communication module (102) has the earliest date / time indication among the other digital communication modules (102A), it is determined that the second medical device data (303) will be transmitted to the EMR server (108) via the digital communication module (102); and The second medical device data (303) is transmitted to the EMR server (108) via communication coupling from the output interface (306) to the medical network (106).

4. The digital communication module (102) according to claim 3, wherein, The data manager (302) is further configured to: Receive third medical device data (303) from one of the other digital communication modules (102A); and The data (303) of the third medical device is transmitted to the EMR server (108) via communication coupling from the output interface (306) to the medical network (106).

5. The digital communication module (102) according to claim 3, wherein, The data manager (302) is further configured to: The new first digital communication module is designated as the node gateway for transmitting data from the medical device (303); and After receiving the power outage message from the first digital communication module and determining that the new first digital communication module has the earliest date / time indication among the other digital communication modules (102A), the new first digital communication module is designated as the node gateway.

6. The digital communication module (102) according to claim 5, wherein, The data manager (302) is further configured to: After designating the new first digital communication module as the node gateway, communication coupling to the EMR server (108) via the output interface (306) is disabled.

7. The digital communication module (102) according to claim 4, wherein, The data manager (302) is further configured to: The new first digital communication module is designated as the node gateway for transmitting data from the medical device (303); and After receiving the power outage message from the first digital communication module and determining that the new first digital communication module has the earliest date / time indication among the other digital communication modules (102A), the new first digital communication module is designated as the node gateway.

8. The digital communication module (102) according to claim 7, wherein, The data manager (302) is further configured to: After designating the new first digital communication module as the node gateway, communication coupling to the EMR server (108) via the output interface (306) is disabled.

9. The digital communication module (102) according to any one of claims 3 to 8, wherein, The processor (107) of the medical device (104) is configured to monitor therapeutic delivery through the medical device and determine first disposable or consumable usage information, the first disposable or consumable usage information including: The type and quantity of single-use items that have been used and must be replaced to perform subsequent treatment; and / or The type and quantity of semi-disposable components that are exhausted or must be replaced; and / or The types and quantities of broken components that must be replaced. The processor (107) stores the usage information of the first disposable item or consumable in a memory, and the usage information of the first disposable item or consumable is transferred to the digital communication module (102) through the communication unit. The data manager (302) is further configured as follows: Receive first disposable or consumable usage information from the medical device (104); Receive second disposable or consumable usage information from the other digital communication module (102A); Combine the usage information of the first disposable item or consumable with the usage information of the second disposable item or consumable; and The combined first disposable item or consumable usage information and the second disposable item or consumable usage information are transmitted to at least one of the EMR server (108) or medical supply server via the communication coupling from the output interface (306) to the medical network (106).

10. The digital communication module (102) according to claim 9, wherein, The processor (107) is configured to determine the usage information of the first disposable item or consumable at the end of the treatment session.

11. The digital communication module (102) according to claim 9, wherein, The single-use disposable items include disposable pipeline sets; or The semi-disposable element includes a concentrate for dialysis fluid preparation or ultrafiltration; or The damaged component includes a sensor or actuator.

12. The digital communication module (102) according to claim 9, wherein, The first and second disposable product or consumable usage information includes information indicating the use of filters, disposable cartridges, tubing sets, dialysis solutions, saline solutions, kidney replacement solutions, warming bags, or disposable sensors.

13. The digital communication module (102) according to any one of claims 1 to 8 and 10 to 12, wherein, The configuration file (332) specifies the destination network address of the EMR server (108), the identifier of the medical device (104) type of the connected medical device (104), the identifier of the medical device (104) serial number, and the timestamp. The medical data received according to the timestamp is generated by the medical device (104) or received by the data manager (302) from the medical device (104).

14. The digital communication module (102) according to any one of claims 1 to 8 and 10 to 12, wherein, The data manager (302) is further configured to: - Receive the data stream from the medical device (303); - Create snapshots of the medical device data (303) at periodic intervals; and - Provide a snapshot of the medical device data (303) as the medical device data (303) transmitted to the first digital communication module. The medical device data (303) includes at least one of the following: Event information, including the transitions between the filling, residence, and discharge phases of the dialysis cycle; Warning, alarm, or event information; Treatment plan information; or Medical treatment data, including at least one of the estimated filling rate, discharge rate, or amount of ultrafiltration removed.

15. The digital communication module (102) according to any one of claims 1 to 8 and 10 to 12, wherein, The data manager (302) is further configured to: Event tracking was used to identify changes in medical device data (303) between snapshots; and Only the medical device data (303) that has changed from the previous snapshot is included as medical device data (303) transmitted to the first digital communication module.

16. The digital communication module (102) according to any one of claims 1 to 8 and 10 to 12, wherein, The data manager (302) is further configured to: A configuration message is received via the output interface (306), the configuration message indicating the network address of the clinician device and the standard for transmitting notifications to the clinician device; It is determined that at least some of the medical device data in the medical device data (303) meets the criteria; and A notification message is transmitted to the clinician device via the proprietary network (400), the notification message indicating that at least some of the medical device data (303) in the medical device data meets the criteria.

17. The digital communication module (102) according to any one of claims 1 to 8 and 10 to 12 is also coupled to at least one other medical device, said at least one other medical device being an infusion pump, wherein, The medical device (104) is a dialysis machine. The at least one other digital communication module (102A) is associated with the infusion pump, and The medical device data (303) from the dialysis machine includes a patient identifier, and the second medical device data (303) from at least one infusion pump includes the same patient identifier and infusion rate. The data manager (302) is further configured to: Receives an indication that adaptive fluid removal operation is enabled; Receive parameter data associated with the patient identifier, the parameter data including one or more of the following: The flow rate of fresh dialysis fluid entering the filtration unit. The flow rate of the waste liquid leaving the filtration unit. The pre-infusion flow rate entering the extracorporeal blood circuit, Post-infusion flow rate after entering the extracorporeal blood circuit. Fluid removal target volume and removal cycle Fluid removal rate, The second medical device data (303) is received from the at least one other digital communication module (102A) via the wireless private network (400). Determine whether the at least one infusion pump is associated with the same patient identifier; The amount of fluid or infusion rate infused into the patient is determined based on the data from the second medical device (303); Updated parameter data is determined based on the parameter data and the amount of fluid or the infusion rate determined from the second medical device data (303) infused into the patient. The updated parameter data is transmitted to the dialysis machine via the input interface (304).

18. The digital communication module (102) according to claim 17, wherein, Taking into account the fluid infused using the infusion pump, the updated parameter data maintains the patient's fluid balance during dialysis.

19. The digital communication module (102) according to claim 17, wherein, The data manager (302) is further configured to: Receive parameter data associated with the patient identifier, the parameter data including: Fluid removal target quantity and removal cycle; or The fluid removal rate of the patient associated with the patient identifier; The updated parameter data is based on at least one updated flow rate for the dialysis machine: The fluid removal target and the removal cycle, or the fluid removal rate; and The volume of fluid infused into the patient or the infusion rate; The at least one updated flow rate is transmitted to the dialysis machine via the input interface (304).

20. The digital communication module (102) according to claim 19, wherein, The delivery of an updated flow rate causes the dialysis machine to display a suggestion on the screen indicating the updated flow rate, or to update the programmed treatment based on the updated flow rate.

21. The digital communication module (102) according to claim 19 or 20, wherein, The updated flow rate includes the fluid removal rate.

22. The digital communication module (102) according to any one of claims 19 and 20, wherein, Determining the at least one updated flow rate includes recalculating one or more flow rates used by the dialysis machine to maintain the patient's fluid balance, the one or more flow rates including one or more of the following: fresh dialysis fluid flow rate entering the filtration unit, waste fluid flow rate leaving the filtration unit, pre-infusion flow rate entering the extracorporeal blood circuit, post-infusion flow rate entering the extracorporeal blood circuit, and fluid removal rate.

23. The digital communication module (102) according to any one of claims 1 to 8, 10 to 12 and 19 to 20, wherein, The data manager (302) is further configured to: Sensor data is received from the EMR server (108) via the medical network (106); The sensor data is transmitted to the medical device (104) via the input interface (304) for display on the screen of the medical device (104); At least some of the medical device data from the sensor data and the medical device data (303) are compared with a stored standard; and At least one suggestion message is transmitted to the medical device (104) via the input interface (304) to cause the screen to display information indicating the comparison.

24. A medical system comprising: -At least one medical device (104), including One or more sensors and one or more actuators, Memory, and The processor (107) is configured to receive data from the one or more sensors and control the one or more actuators to perform medical tasks. The processor (107) is able to access the memory and is configured to store data including medical device data (303); A communication unit is connected to the processor (107), the communication unit including at least one of a serial input port, an Ethernet input port and a wireless input port; - At least one digital communication module (102) according to any one of claims 1 to 23 is associated with the medical device (104).

25. The medical system according to claim 24, further comprising: - A plurality of medical devices (104) and a plurality of digital communication modules (102A-0 to 102A-6), each of the plurality of medical devices (104) being associated with a respective digital communication module (102) of the plurality of digital communication modules (102A-0 to 102A-6). The plurality of digital communication modules (102A-0 to 102A-6) are configured to designate one digital communication module (102) as a node gateway that is uniquely connected to the medical network (106).

26. The medical system according to claim 25, wherein, Each of the plurality of digital communication modules (102A-0 to 102A-6) transmits its own medical device data (303) to the node gateway digital communication module at least once, and the node gateway digital communication module routes the received medical device data (303) to the medical network (106).

27. The medical system according to any one of claims 24 to 26, wherein, The medical device (104) is a medical fluid delivery machine, wherein the one or more actuators include one or more pumps.

28. The medical system according to claim 27, wherein, The medical device (104) is a device for treating kidney disease using extracorporeal blood circulation, comprising: - The filtration unit has a primary chamber and a secondary chamber separated by a semi-permeable membrane; - Blood circulation circuits, including: A blood collection line extends between a first end connected to the inlet of the primary chamber and a second end for connection to the patient; and A blood return line extends between a first end connected to the outlet of the primary chamber and a second end for connection to the patient; - A blood pump, used to circulate blood in the blood circuit; - A dialysate line is connected to the outlet of the secondary chamber.

29. The medical system according to claim 28, wherein, The medical device (104) also includes: One or more tubing lines are used to transfer their respective solutions into the bloodstream.

30. The medical system according to any one of claims 24 to 26 and 28 to 29 further includes a medical network and an electronic medical record (EMR) server (108). in, The medical network (106) includes at least one of a Wi-Fi network or an Ethernet network, and the digital communication module (102) transmits the medical device data (303) to the medical network for inclusion in the EMR server (108), wherein the proprietary wireless communication network is separate from the medical network.

31. A digital communication module (102), comprising: An input interface (304) is configured to be communicatively coupled to a medical device (104), the input interface (304) including at least one of a serial input port, an Ethernet input port, and a wireless input port; An output interface (306) is configured to be communicatively coupled to (i) at least one other digital communication module (102A) via a wireless proprietary network (400) and communicatively coupled to (ii) a clinician device (322) via the wireless proprietary network or a direct wireless link, the output interface (306) including at least one of an Ethernet output port or a wireless output port; Memory device (112) is configured to store at least one configuration file (332), the at least one configuration file having a network address or identifier of a clinician device (322) and standards for transmitting notifications to the clinician device; and A data manager (302), communicatively coupled to the input interface (304), the output interface (306), and the memory device (112), is configured to: Receive a stream of medical device data (303) from the medical device (104), the stream of medical device data (303) comprising at least one of the following: Event information, including the transitions between the filling, residence, and discharge phases of the dialysis cycle; Warning, alarm, or event information; Treatment plan information; or Medical treatment data, including at least one of the estimated filling rate, discharge rate, or amount of ultrafiltration removed; Determine that at least some of the medical device data in the medical device data (303) meet the criteria; Snapshots of the medical device data (303) are created at periodic intervals; A notification message is transmitted to the clinician device (322) via the wireless private network (400) or the direct wireless link, the notification message indicating that at least some of the medical device data in the medical device data meets the standard; Provide a snapshot of the medical device data (303) as medical device data (303) transmitted via the wireless proprietary network (400) to the first digital communication module in the at least one other digital communication module (102A). The data manager (302) is further configured as follows: Event tracking is used to identify changes in the medical device data (303) between snapshots; and Only the medical device data (303) that has been modified from the previous snapshot is included as the medical device data (303) transmitted via the wireless proprietary network (400) to the first digital communication module in the at least one other digital communication module (102A).

32. The digital communication module (102) according to claim 31, wherein, The data manager (302) is further configured to: - Authorized connections from the clinician device (322) are permitted; - Provide a template form that requests data about which notifications are expected, including setting thresholds and / or conditions for when to generate notifications; - Use template table data to set the criteria.

33. The digital communication module (102) according to claim 32, wherein, The template form requests the priority of warnings, events, or alerts.

34. The digital communication module (102) according to any one of claims 31 to 33, wherein, The data manager (302) is configured to broadcast and rebroadcast the notification message to ensure that the message reaches the clinician device (322), wherein the data manager (302) is configured to rebroadcast the notification message until a maximum broadcast time, a maximum number of broadcasts have been performed, or an acknowledgment message is received from the clinician device (322) when the notification message is received.

35. The digital communication module (102) according to any one of claims 31 to 33, wherein, The wireless private network (400) includes at least one of the following: Zigbee® wireless protocol, Z-Wave® wireless protocol, WeMo® wireless protocol, or Low Power Wide Area Network ("LPWAN") wireless protocol. The direct wireless link is provided using at least one of the Bluetooth® wireless protocol, the Bluetooth® mesh wireless protocol, or the Bluetooth® 5.0 wireless protocol.

36. The digital communication module (102) according to any one of claims 31 to 33, wherein, The direct wireless link is included as part of the wireless private network (400).

37. The digital communication module (102) according to any one of claims 31 to 33, wherein, The criteria used for notification correspond to at least one of a warning, alarm, or event.

38. A method for transferring medical device data (303) from at least one medical device (104) to an EMR server (108) via at least one digital communication module (102), in, The medical device (104) includes: One or more sensors and one or more actuators, Memory, and The processor (107) is configured to receive data from the one or more sensors and control the one or more actuators to perform medical tasks. The processor (107) is able to access the memory and is configured to store data including medical device data (303); A communication unit is connected to the processor (107), the communication unit including at least one of a serial input port, an Ethernet input port and a wireless input port; The digital communication module (102) includes: An input interface (304) is coupled for communicating with a communication unit of the medical device (104), the input interface (304) including at least one of a serial input port, an Ethernet input port and a wireless input port; The output interface (306) is configured to be communicatively coupled to (i) an electronic medical record (EMR) server (108) via a medical network (106) and communicatively coupled to (ii) at least one other digital communication module (102A) via a wireless private network (400), the output interface (306) including at least one of a serial output port, an Ethernet output port or a wireless output port; The file configuration manager (330) is configured to store at least one configuration file (332) having an identifier of the digital communication module (102); and The data manager (302) is communicatively coupled to the input interface (304), the output interface (306), and the file configuration manager (330). The method includes: The digital communication module (102) is coupled to the medical device (104). The digital communication module (102) is coupled to the EMR server (108). After power-on, the data manager (302) transmits a wake-up message via the wireless private network (400) to the at least one other digital communication module (102A). The wake-up message includes the identifier of the digital communication module (102) and a date / time indication of power-on. The system receives a response message from each of the at least one other digital communication module (102A) via the wireless private network (400). The response message includes an identifier or network address of each other digital communication module (102A) and a date / time indication of when each other digital communication module (102A) is powered on. Receive medical device data (303) from the medical device (104). The medical device data (303) to be transmitted to the EMR server (108) via the first digital communication module (102A) having the earliest date / time indication, and The medical device data (303) is transmitted to the first digital communication module for transmission to the EMR server (108).

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