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WO2018022355A1 - Clonage de configurations de dispositif médical - Google Patents

Clonage de configurations de dispositif médical Download PDF

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Publication number
WO2018022355A1
WO2018022355A1 PCT/US2017/042633 US2017042633W WO2018022355A1 WO 2018022355 A1 WO2018022355 A1 WO 2018022355A1 US 2017042633 W US2017042633 W US 2017042633W WO 2018022355 A1 WO2018022355 A1 WO 2018022355A1
Authority
WO
WIPO (PCT)
Prior art keywords
medical devices
child
parent
operating parameters
medical device
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2017/042633
Other languages
English (en)
Inventor
Donald Eugene DIEZ
Glen James LARSON
Jennifer Lynn Pavlovic
James B. Drost
Grant A. Adams
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Smiths Medical ASD Inc
Original Assignee
Smiths Medical ASD Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smiths Medical ASD Inc filed Critical Smiths Medical ASD Inc
Publication of WO2018022355A1 publication Critical patent/WO2018022355A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3561—Range local, e.g. within room or hospital
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502—User interfaces, e.g. screens or keyboards
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/008—Racks for supporting syringes or needles

Definitions

  • Embodiments relate generally to communication and control components and systems for medical devices and, more particularly, to informational, advisory, and control devices and systems for infusion pumps and other coordinated medical devices. Embodiments specifically include systems, methods and apparatus for locally transferring operating parameters between medical devices.
  • infusion pumps have been useful for managing the delivery and dispensation of a prescribed amount or dose of a drug, fluid, fluid- like substance, or medicament (hereinafter, collectively, an "infusate") to patients.
  • Infusion pumps can provide some significant advantages over manual infusion techniques, by accurately delivering and dispensing infusates over an extended period of time.
  • Infusion pumps are particularly useful for treating diseases and disorders that require regular pharmacological intervention, including cancer, diabetes, and vascular, neurological, and metabolic disorders. They also enhance the ability of healthcare providers to deliver anesthesia and manage pain.
  • Infusion pumps are used in various settings, including hospitals, nursing homes, and other short-term and long-term medical facilities, as well as in residential care settings.
  • Infusion pumps can include various constructions, modes of operation, and types.
  • infusion pumps include portable or ambulatory pumps, large volume pumps (LVPs), patient-controlled analgesia (PCA) pumps, peristaltic pumps, elastomeric pumps, syringe pumps, enteral pumps, and insulin pumps.
  • LVPs large volume pumps
  • PCA patient-controlled analgesia
  • peristaltic pumps elastomeric pumps
  • syringe pumps elastomeric pumps
  • enteral pumps syringe pumps
  • insulin pumps Depending upon their specific designs and intended uses, infusion pumps can be used to administer infusates through various delivery methods, including intravenously, intraperitoneally, intra-arterially, subcutaneously, neuraxially, and specifically into an intraoperative site, epidural space, and subarachnoid space.
  • the "five rights of medication administration”, commonly referenced in connection with ensuring safe infusions, are: the right medication (determining if a particular infusate has been prescribed correctly); the right patient (determining if the infusate was prescribed for the correct patient); the right dose (determining what volume or how many milliliters, tablets, or doses of the infusate are to be given to the patient); the right route (determining if the infusate should be given to the patient intravenously or by mouth, feeding tube, or other injection, etc.); and the right time (determining what time of day the infusate should be delivered to the patient). Accordingly, most infusion pump manufacturers and users have been keenly interested in ensuring that these "five rights" are implemented, observed, and verified.
  • Infusion pumps may be controlled locally via the programming of each individual pump. For example, a medical practitioner can configure an infusion pump to execute a delivery profile that corresponds to a patient's treatment needs, or a patient can configure an infusion pump according to their individual requirements within pre-defined limits without the involvement of a physician.
  • infusion pumps may be controlled via other techniques such as by, for example, a network server that communicates with the pumps.
  • Hospital information systems (HIS) and electronic medical record (EMR) systems may, in some circumstances, provide such network functionality.
  • an infusion pump is specifically programmed or configured according to certain physiological, pharmacokinetic, and operational parameters or limits that are often predefined and with the safety provisions of the "five rights" in mind.
  • infusion pumps have become increasingly sophisticated and may include such features as close error reduction software, which enable infusion pumps to perform functions that assist in proper programming and calculating of dosing and delivery rates in an effort to reduce medication errors and potentially consequential patient harm.
  • Infusion pumps can also be programmed or configured to access databases (often referred to as "drug libraries") containing information relating to medications that can be used with a specific pump, as well as information corresponding to dosing guidelines, drug concentrations, dose limits, and clinical advisories.
  • drug libraries databases
  • Such features can include medication safety software and "guard toolboxes" and servers.
  • healthcare facilities can integrate infusion pumps with electronic medical records, computerized order entry systems, and medication recognition systems, such as, e.g., barcode scanning systems, to further enhance safety and efficacy.
  • Healthcare facilities can also choose to generally or specifically implement dosing and delivery limitations, commonly called hard and soft limits, on preselected drugs.
  • infusion pumps are individually programmed, meaning that concentration limits, volume limits, and other limits or boundaries, as well as other medicament or drug programming parameters are set individually for each such infusate and the pump is programmed within those boundaries.
  • concentration limits, volume limits, and other limits or boundaries, as well as other medicament or drug programming parameters are set individually for each such infusate and the pump is programmed within those boundaries.
  • a medical practitioner or doctor must spend time programming each of the infusion pumps separately, and respectively program each of the infusion pumps. It can take substantial effort and time to program all of the infusion pumps needed for a particular patient or procedure. Over the course of a week, this can easily mean hours of infusion pump programming. This sort of repetitive, individual programming of pumps can be laborious, time-consuming, and subject to human error.
  • Embodiments described or otherwise contemplated herein substantially provide the aforementioned advantages of providing or improving patient safety, workflow efficiency, programming, control, and operational parameters or limits, among possible other advantages.
  • One embodiment relates to a system of localized cloning of a plurality of child medical devices with common operating parameters of a parent medical device.
  • the system includes a rack including a plurality of mounting structures configured to physically and removably couple a plurality of child medical devices and a parent medical device.
  • the system also includes a digital communication bus provided on the rack that enables communication between the parent medical device and the plurality of child medical devices that are coupled to the rack.
  • the parent medical device can adjust one or more operating parameters of the plurality of child medical devices with communications sent via the digital communication bus.
  • Another embodiment relates to a system for configuring a selected operating parameter for a plurality of medical devices.
  • the system includes a rack, configured to physically and removably couple the plurality of medical devices as well as a router, configured to enable digital communications between the plurality of medical devices that are physically and removably coupled to the rack with a local area network. Further, a selected one of the plurality of medical devices communicates the selected operating parameter to others of the plurality of medical devices depending upon whether the plurality of medical devices are physically coupled to the rack and communicatively coupled to the local area network through the router.
  • An embodiment relates to a mounting rack for localized cloning of a plurality of child medical devices with operating parameters of a parent medical device.
  • the mounting rack includes a mounting structure including a plurality of coupleable receptacles that are each structured to receive one of a plurality of medical devices as well as a digital communication bus including a set of communication hardware integrated between the plurality of coupleable receptacles.
  • the plurality of medical devices are releaseably coupled to the rack and readily transfer a set of operating parameters from a parent medical device to one or more child medical devices.
  • the infusion pump includes a pump housing, a pumping mechanism, a pump control system and a control module.
  • the pumping mechanism is coupled to the pump housing that selectively delivers an infusate to a patient.
  • the pump control system includes a processor and a memory programmable to control operation of the pumping mechanism.
  • the control module relays commands to the pump control system including a user interface.
  • the user interface provides selection of multiple operation modes including a parent clone mode, enabling transfer of operating parameters and a child clone mode, enabling receipt of operating parameters.
  • the parent clone mode includes searching to locate one or more child infusion pumps connected to a common local access point for medical devices, displaying one or more child clone pumps on a pump screen/display, establishing a connection with each of the one or more child clone pumps, transferring desired operating parameters and information to each of the child clone pumps, verifying transferred operating parameters and information is correct, and collecting information regarding the transfer.
  • the child clone mode includes: searching to locate a parent clone infusion pump connected to a common local access point for medical devices, displaying the parent pump on a pump screen, establishing a connection with the parent clone infusion pump, receiving desired operating parameters and information from the parent clone infusion pump, verifying transferred operating parameters and information is correct, and collecting information regarding the transfer.
  • Another embodiment includes a method of localized cloning of a medical device.
  • the method includes: connecting a parent medical device to a mounting rack, connecting one or more child medical devices to the mounting rack, establishing a set of operating parameters for the parent medical device, initiating a search enabling the parent medical device and the one or more child medical devices to recognize one another to establish a connection, and approving transfer of the set of operating parameters from the parent medical device to the one or more child medical devices. Some embodiments further including verifying that the set of operating parameters was transferred.
  • a further embodiment relates to a method of localized cloning of a medical device.
  • the method includes: searching for one or more child medical devices to the medical device that are connected to a common a digital communication bus and coupled to a common mounting structure, displaying the one or more child medical devices on a display of the medical device, establishing a connection with each of the one or more child medical devices, transferring operating parameters to each of the one or more child medical devices, verifying that the operating parameters transferred are correct, and collecting information regarding transfer of the operating parameters.
  • FIGS. 1 A-C are various infusion pumps that are examples of medical devices that can be part of localized cloning systems, applications or methods, according to various embodiments.
  • FIG. 2 is a block diagram of various elements of an infusion pump system that can be part of localized cloning systems, applications or methods, according to various embodiments.
  • FIG. 3 is an example of a mounting rack including a plurality of infusion pumps coupled to the mounting rack, according to an embodiment.
  • FIG. 4 is a diagram of a localized cloning system for medical devices, according to an embodiment.
  • FIG. 5 is a diagram showing a localized cloning of medical devices arrangement, according to an embodiment.
  • FIG. 6 is a diagram showing a localized cloning of medical devices arrangement, according to an embodiment.
  • FIG. 7 is a diagram showing a localized cloning arrangement, according to an embodiment.
  • FIG. 8 is a flow chart of a method of localized cloning of a medical device, according to an embodiment.
  • FIG. 9 is a flow chart of a method of localized cloning of a medical device, according to an embodiment.
  • Medical device systems including multiple programmed infusion pumps and/or other medical devices are increasingly complex.
  • the need for and advantages of a simplified setup and control for these types of systems has been recognized by applicants.
  • the following disclosure relates to specifically to technology and methods aimed at this.
  • “Inform” pertains to a linking and transfer of patient and medical device data for both use and view by means of a portal or user interface; "Advise” pertains to use of the “Inform” data to derive clinical suggestions or recommendations for a particular patient's therapy; and "Control” pertains to use of, for example, algorithms and/or real-time patient data to change a therapy, with or without direct involvement of a medical practitioner.
  • "Inform” (if included in a particular embodiment) could assist in meeting a practitioner's need or desire for easily and efficiently obtaining data from a medical device or coordinated group of devices in treatment of a particular patient.
  • data could include, for example, information on the status and operating parameters of the device or group of devices and/or so-called Continuous Quality Improvement or "CQI" data.
  • CQI Continuous Quality Improvement
  • the data could also be used, for example, to populate the EMR.
  • “Advise” (if included in a particular embodiment) could assist in meeting a practitioner's need or desire for easily and efficiently obtaining more information on how to improve clinical outcomes and/or provide recommended therapies.
  • Embodiments of an Inform / Advise / Control system could be decidedly advantageous in provision or improvement of patient safety, workflow efficiency, programming, control, and operational parameters or limits, etc., for infusion pumps and other coordinated medical devices.
  • One specific area involving an Inform / Advise / Control type system which applicants have identified for improvement relates to efficiently programming multiple medical devices such as infusion pumps. Users often would prefer not to set up multiple related medical devices manually. In general, setting up multiple medical devices manually can be time-consuming, repetitive, or otherwise undesirable as a task for users, such as medical staff or professionals. Accordingly, the described cloning system or device, where one medical device readily reconfigures other medical devices to be generally identical copies or at least contain a set of common operating parameters, is highly desirable.
  • a parent medical device set-up can locally originate from another source. Once the parent medical device is configured, it can then be used to transfer information to other "child" medical devices by localized transfer and subsequent local transfers throughout the facility or healthcare system.
  • the type of localized cloning systems contemplated by this disclosure can be advantageous in many ways. For example, many facilities currently do not have server systems for sharing operational configurations in a large system-wide fashion. This method provides cloning of medical devices without requiring a server system or computer to be present. This system can also be adapted to provide a level of security to the medical device configurations themselves.
  • FIGS. 1A-C show various pumps 100 as examples of medical devices that can be used in Inform / Advise / Control systems.
  • the pumps 100 also referred to and distinguished more specifically as pumps 100A, 100B and lOOC, respectively, in FIGS 1A, IB, and 1C
  • the pumps 100 are examples of various infusion pumps that can be used in a localized cloning system or method.
  • Infusion pumps 100A and 100B are a syringe-type pumps that can be used to deliver a wide range of drug therapies and treatments.
  • Infusion pumps 100A and 100B include a pharmaceutical container or syringe 110, which is supported on and secured to housing 120 by clamp 130, respectively.
  • syringe 110 can be separately supplied from the respective pump 100.
  • syringe 110 is an integrated component of pump 100.
  • Syringe 110 includes a plunger 140 that forces fluid outwardly from syringe 110 via infusion line 160 that is connected to a patient.
  • a motor and lead screw arrangement internal to housing 120 of pump 100 cooperatively actuates a pusher or plunger driver mechanism 170, to move plunger 140.
  • a sensor can monitor force and/or position of the plunger 140 in the syringe 110 according to system specifications.
  • depicted on the pumps 100A and 100B is at least one user interface 172 for operator input and/or display 174.
  • the display 174 can also be combined with or serve as part of a user interface 172 as a touch screen or touchless interface, for example.
  • Infusion pump lOOC shown in FIG. 1C is an example of an ambulatory infusion pump that can be used to deliver a wide range of drug therapies and treatments.
  • Such ambulatory pumps can be comfortably worn by or otherwise removably coupled to a user for in-home ambulatory care by way of belts, straps, clips or other simple fastening means, and can also be alternatively provided in ambulatory pole-mounted arrangements within hospitals and other medical care facilities.
  • Infusion pump lOOC generally includes a peristaltic type infusion pump mechanism that controls the flow of medication from a reservoir (not shown in FIG. 1C) of fluid coupled to pump lOOC through a conduit from the reservoir which matingly passes along bottom surface 180 of pump lOOC.
  • the reservoir can comprise a cassette that is attached to the bottom of pump lOOC at surface 180, or an IV bag or other fluid source that is similarly connected to pump lOOC via an adapter plate (not shown) at surface 180.
  • pump lOOC uses valves and an expulsor located on bottom surface 180 to selectively squeeze a tube of fluid (not shown) connected to the reservoir to effect the movement of the fluid supplied by the reservoir through the tube and to a patient in peristaltic pumping fashion.
  • Pump lOOC also has at least one user interface 182 for operator input and/or display 184.
  • the display 184 can also be combined with or serve as part of a user interface 182 as a touch screen or touchless interface, for example.
  • Infusion pumps 100A, 100B, and lOOC are each examples of infusion pumps that can be suitable for use with embodiments discussed herein, though other pumps and devices can be used in various other embodiments of infusion systems utilizing subject matter hereof.
  • FIG. 2 is a block diagram of an infusion pump system 200.
  • System 200 includes infusion pump 100 having pump control system 202 with processor 204 and memory 206 programmable with selected protocols, profiles, segments of profiles, and other settings for controlling operation of pumping mechanism 208 such as, for example, the aforementioned syringe and ambulatory or peristaltic type mechanisms that can draw infusate from a reservoir or other fluid or infusate source 210.
  • reservoir 210 can comprise any suitable infusate supply, such as an IV bag, syringe, continuous supply, or other infusate storage.
  • Processor 204 can be any programmable device that accepts digital data as input, is configured to process the input according to instructions or algorithms, and provides results as outputs.
  • processor 204 can be a central processing unit (CPU) configured to carry out the instructions of a computer program.
  • processor 204 can be an application specific integrated circuit (ASIC) or a field-programmable gate array (FPGA).
  • ASIC application specific integrated circuit
  • FPGA field-programmable gate array
  • memory 206 can comprise volatile or non-volatile memory as required by the coupled processor 204 to not only provide space to execute the instructions or algorithms, but to provide the space to store the instructions themselves.
  • volatile memory can include random access memory (RAM), dynamic random access memory (DRAM), or static random access memory (SRAM), for example.
  • non-volatile memory can include read-only memory, flash memory, ferroelectric RAM, hard disk, floppy disk, magnetic tape, or optical disc storage, for example.
  • the infusion pump 100 also includes a control module 220 for relaying commands to the pump control system 245.
  • Control module 220 includes at least one user interface 230 utilizing an operator input including input mechanism(s) 235, that works cohesively with a display screen 225. In some cases, the display 225 will be considered part of the user interface(s) 230. In some embodiments, operation modes including a parent clone mode and a child clone mode may be selectable by this user interface 230.
  • User interface 230 generally allows a user to enter various operating parameters, including but not limited to names, drug information, limits, delivery shapes, information relating to hospital facilities, as well as various user-specific operating parameters (e.g., patient age and/or weight).
  • the infusion pump 100 includes a USB port or other appropriate input/output (I/O) interface port 240 for connecting the infusion pump 100 to a network or computer 250 having software designed to interface with the infusion pump 100.
  • I/O input/output
  • the input/output port 240 may also be useful for connecting to a rack or other hardware for localized wired or wireless networking or connectivity. Embodiments relating to rack and other subnet or hardware arrangements will be discussed later in greater detail. Power to the infusion pump 100 is accomplished via an AC power cord or internally provided battery.
  • User inputs 260 to the system are provided by programming of a user such as a nurse, physician, or other medical practitioner. These inputs 260 can include a variety of forms. The inputs 260 are generally received by the operator input mechanisms 235.
  • pole 310 may be any suitable and generally vertical support structure such as is commonly used for suspending elevated intravenous (IV) fluid reservoirs, bags, and the like.
  • a rack 302 is coupled to pole 310 by way of pole clamp and pumps 100 are each removably couplable to rack 302. In other embodiments, rack 302 may be freestanding or coupled to other structures or support features.
  • mounting rack 302 includes a plurality of infusion pumps 100 coupled to the mounting rack 302 that are vertically aligned, stacked, and coupled to the mounting rack 302.
  • Infusion pumps 100 merely represent one type of medical device that could be mounted on a rack 302.
  • Other medical devices of various shapes sizes and functions could be coupled to a rack as well.
  • Examples of other medical devices include various types of monitors, sensors and status/ alerting devices (e.g. pulse oximeters, blood pressure monitors, blood gas sensors, breathing assistance devices, and core temperature sensors, among others) that are routinely used in hospital settings for patient care.
  • the system is "localized" as cloned parameters are configured and transmitted in close physical proximity and/or to a limited group of interconnected devices. Cloning is not performed in a system-wide, centralized manner but through local device to device interactions, via rack 302, local router, or other intermediary structures in certain embodiments, in which local transmission of information or operating parameters from one physical device to another is made possible.
  • FIG. 4 depicts a diagram of a localized cloning system 400, similar to the specific localized cloning system 300 shown in FIG. 3.
  • the system 400 includes a rack 402, digital communication bus 404, router 406, and a plurality of medical devices 410, 420, 430, 440 and 450.
  • System 400 can be understood in certain embodiments as providing localized cloning of operating parameters of one medical device to a plurality of other medical devices, all coupled to a common local component or interface.
  • the one medical device will be identified as a parent medical device 410 and the plurality of other medical devices will be referred to as child medical devices 420, 430, 440 and 450.
  • any of the medical devices could be deemed the parent device as this function is not necessarily dictated by pump physical location or position.
  • four child medical devices are shown, this number of child medical devices should not be viewed as limiting. Fewer or additional medical devices may be present in certain embodiments.
  • rack 402 can take on various shapes and sizes.
  • rack 402 may be similar to the rack 302 shown in FIG. 3. However, the shape and size of rack 402 is not limited to such an arrangement and can be a structure suitably adapted to effectively mount and connect the various medical devices desired.
  • Rack 402 generally includes at least a plurality of mounting structures 460 configured to physically and removably couple the plurality of child medical devices 420, 430, 440 and 450 to a parent medical device 410.
  • Mounting structures 460 can include any attachment structure or mechanism used to physically couple the medical devices to the rack 402.
  • Digital communication bus 404 is shown as integrated with or on rack 402.
  • Digital communication bus 404 enables communication between the parent medical device 410 and the plurality of child medical devices 420, 430, 440 and 450 that are coupled to the rack 402.
  • Medical devices 410, 420, 430, 440 and 450 may be infusion pumps 100, as shown in FIGS. 1 A-C and/or FIG. 2 in some embodiments.
  • Digital communication bus 404 generally refers to a communication system that transfers data between components inside a computing device, or between computing devices.
  • bus 404 can cover all related hardware components (wire, optical fiber, etc.) and software, including communication protocols.
  • Bus 404 could utilize an Ethernet, SPI, CAN, RS232, wireless or other communication architecture or method.
  • Bus 404 can include a wireless digital communications bus or other wireless communications architecture.
  • digital communication bus 404 may include a router 406.
  • Router 406 can be configured to enable digital communications between the medical devices 410, 420, 430, 440 and 450 that are physically and removably coupled to the rack 402 and into a local area network (LAN) 408, in certain embodiments.
  • LAN local area network
  • medical devices may not be physically coupled to a common rack, but rather, be part of a group of devices associated with one another by way of a connection to a common local access point. In some cases, this local access point can be a wired or wireless router that manages devices in close proximity.
  • a rack 402 of medical devices 410, 420, 430, 440 and 450 can be an isolated subnet in a larger communication network.
  • the medical devices on rack 402 can identify that only the medical devices also mounted to the rack are viable partners for the operation. This obviates the possibility that random medical devices in a facility will mistakenly be re-configured. For example, such identification can be implemented by any suitable "five rights" scheme or procedure.
  • the medical devices mounted to the rack can be identified by a hardware ID such as a media access control (MAC) address, a software ID such as a message header or unique packet identifier, or a network ID such as a subnet mask.
  • MAC media access control
  • a data structure can be configured to store the subset of medical devices that are identified as viable configuration partners.
  • the complete internal set-up of a single medical device 410 can be passed to other medical devices 420, 430, 440 and 450 using a digital communication pathway through mounting rack 402.
  • the "complete" set-up includes any downloaded information and modifications to the medical device set-up done on the parent medical device 410.
  • the locally-made configuration may include how alarms are handled (i.e. alarm settings), display intensity and mode, drug library used and any other operating characteristic that can be modified at the medical device 410.
  • medical device set-up may include cloning firmware or various pieces of software.
  • cloning a configuration can include sharing alarms or patient data, for example.
  • operating parameters can relate to firmware updates or medical device set-up.
  • medical device set-up includes networking of infusion pumps (including syringe pumps and LVPs) for a particular facility.
  • medical device set-up includes establishing Ethernet connections or credentials.
  • Medical device set-up can include setting up authentication protocols, permission levels, or passwords.
  • medical device set-up includes a merger of event histories. For example, the event history of a parent infusion pump can merge with the event history of a cloned child infusion pump, so as to create a single data file of event history information for both devices.
  • the parent medical devices 410 can be configured from a server, PC-based configuration tool, or in manufacturing, to be the "source" and have its information passed to other child medical devices 420, 430, 440 and 450.
  • FIG. 5 Shown in FIG. 5 is a diagram of a system 500 providing localized cloning of medical devices. See medical devices 502, 504, 506, 508 and 510.
  • a child medical device 504a after cloning by a parent clone 502a, can become a parent clone 504b to another medical device 506 in a "train the trainers" relationship.
  • child clone 506a could become parent clone 506b to clone medical device 508.
  • Child clone 508a would become parent clone 508b to clone medical device 510. This parent and child cloning arrangement can, accordingly, continue as extensively as desired.
  • medical devices 502, 504, 506, 508 and 510 can have two additional operating modes: a "clone parent" mode; and "clone child” mode.
  • a "clone parent” mode When placed into their respective parent or child cloning mode, the medical devices 502, 504, 506, 508 and 510 will search for appropriate partners on the digital communication bus 404. As partners are found, they are displayed on the display screen of the medical device, such as, for example, display 174 or 184 in Figs. 1A-C. Two "clone parents” would be an error as one, and only one, parent would be allowed. However, there can be one or more "clone children". Once a successful configuration has been made consisting of one parent and one or more children, the cloning operation may be started.
  • Cloning will include transferring the configuration and verifying that the transfer was correct. In some embodiments, cloning will not be permitted while a medical device is in operation for safety reasons. For example, while an infusion pump is performing an infusion it will typically not be involved in cloning parameters in other medical devices in any way. In some embodiments, cloning parameters can be downloaded and installed after an infusion is complete. In some embodiments, a user may be prompted to complete cloning or initiate downloading of parameters. In other embodiments, robust communications, software, and safety measures will enable simultaneous updates at any time regardless of whether an infusion delivery to a patient is ongoing.
  • Some embodiments can require that an infusion pump or medical device be placed in a particular operating mode for cloning operations to take place. In some embodiments, no particular operating mode is necessary for cloning operations.
  • the system can be arranged to so that a parent medical device and a rack can operate as a type of production fixture in which a many child pumps can be attached to the rack at once for rapid cloning. See FIGS. 6 and 7 also.
  • eleven child infusion pumps can be attached to a rack and cloned simultaneously. This type of cloning could be made persistent and accordingly, provide a semi-automatic arrangement in which a parent is left in a rack and child pumps are added and removed under the assumption that newly added pumps to the rack are child pumps.
  • default relationships of parent and child pumps can be established for cloning operations. Using such default parameters and relationships enables safety measures to be built and put in place.
  • cloning changes to certain portions of an infusion pump drug library can be restricted or entirely prevented. This type of restriction can segregate out parts of a drug library which present a high level of safety risk if incorrectly altered or compromised.
  • an pump administering anesthesia or a pump administering infusions in a NICU may include restrictions. Restrictions on cloning may be put in place to prevent syringe pump programming from being cloned to LVP pumps and vise versa. In general, restrictions can be implemented to prevent cloning operating parameters that are vastly different from one another.
  • Authorization restrictions can also be implemented in medical device cloning based on event history data.
  • event history data When cloning operations take place, the who, when, and where of these data transfers is recorded. For example, the location of infusion pumps being cloned can be recorded (whether wired on a rack or wireless) as well as a time and date stamp. This can be done with the aid of information such as IP location, GPS, or other location-based identifiers. The serial number of the parent cloning pump and the child receiving pump can, likewise, be recorded for tracking and approval purposes. Tracking this information lends itself to numerous safety and ease-of-use advantages. In terms of creating a record, embodiments that create a merged event history record each time a cloning operation takes place, enables a consolidated data file for both pumps. Consolidated data files of this type can be of assistance in the review of medical device information.
  • Cloning medical devices can also provide benefits in difficult operating environments, such as the battlefield. Simplifying programming and reducing the possibility of user errors can be extremely important in these locations where efficiency is at a premium and the margin for errors is reduced.
  • FIG. 6 is another diagram of a system 600 providing localized cloning of medical devices
  • the system uniformly uses medical device 602 as a parent clone 602a to concurrently program a plurality of medical devices 604, 614 and 624.
  • these medical devices can, in turn, be used to accept operating parameters or other programming as a child clone 604a, 614a and 624a.
  • the medical devices then can subsequently be configured to operate as a parent clone 604b and 624b in some cases to further pass on operating parameters to other devices such as medical devices 606, 608, 610, and 626 using parent and child cloning relationships as discussed above.
  • Systems 600 can be configured in various ways and are not limited to one particular configuration, number of devices, or structure.
  • FIG. 7 is a diagram showing a system 700 representing a localized cloning arrangement.
  • cloning between pumps 710, 720 and 730 is local, however, cloning does not necessarily require transfer of operating parameters over a structure, such as a piece of physical hardware with a digital communication bus.
  • parent infusion pump 710 transfers operating parameters wirelessly to infusion pumps 720 and 730, such that each pump need not be individually programmed by the user.
  • Even pumps commonly mounted to a rack or other structure may communicate wirelessly, rather than via a physical wired connection of a bus at times.
  • Wireless communication technologies that can be used to interconnect medical devices with one another include: infrared communication; ultrasonic communication; Bluetooth®; peer-to-peer or network-based WiFi; short range communication (i.e. ZigBee, ANT, etc.); near-field communication (NFC); and radio-frequency identification (RFID) communication.
  • These wireless technologies can enable the rapid expansion of protocols from one medical device to many medical devices. Accordingly, use of a series of medical devices connected to a common access point, such as a wireless router, can make up a wireless local cloning system. For example, a single access point in a hospital ICU could be responsible for managing cloning infusion pumps in that ICU.
  • Bluetooth® for example can be effectively used as the communications vehicle in various cloning arrangements. Due to the localized nature of Bluetooth® communications, the inherent proximity limitations of such an arrangement can serve as a control safety measure.
  • a further cloning arrangement relates to use of a USB stick to provide the localized cloning arrangement.
  • a rack or router can include a USB port that can supply information to a local group of medical devices.
  • the device containing the USB stick accordingly, acts as the parent device and connected devices serve as child devices.
  • the USB stick would include a configuration file in a format that can be readily accessed and the medical device is permitted to write to that same media.
  • This arrangement can simplify merger of history files onto a single file on the USB stick.
  • the USB stick can then provide automatic uploads and creates a convenient reporting mechanism for reports.
  • FIG. 8 sets forth a flow chart of a method 800 of localized cloning of a medical device.
  • the operator connects a parent medical device (i.e. medical device 410 from FIG. 4), to a mounting rack (i.e. rack 402).
  • the operator connects one or more child medical devices (i.e. medical devices 420, 430, 440, and 450) to the mounting rack.
  • a set of operating parameters is established for the parent medical device. Once operating parameters are established, as at 808, the operator can initiate a search enabling the parent medical device and the one or more child medical devices to recognize one another to establish a connection.
  • transfer of the operating parameters is approved from the parent medical device to the one or more child medical devices.
  • verification of the desired set of operating parameters transferred can take place.
  • FIG. 9 Shown in FIG. 9 is another flow chart of a method 900 of localized cloning of a medical device.
  • the method 900 includes searching, at 902, for one or more child medical devices (i.e. medical devices 420, 430, 440, and 450 from FIG. 4) to a medical device (i.e. medical device 410) that are connected to a common a digital communication bus (i.e. bus 404) and coupled to a common mounting structure (i.e. mounting structure 460).
  • the one or more child medical devices are displayed on a display (such as displays 174, 184 and/or 225) of the medical device.
  • a connection is established with each of the one or more child medical devices and at 908 operating parameters are transferred to each of the one or more child medical devices.
  • the correctness of the operating parameters transferred is verified and, at 912, information regarding transfer of the operating parameters is collected.
  • the one medical device controller could "clone" a pump 100 in a rack 302 of pumps 100 (referred to as a smart pump stack). See FIG. 3, for example. Accordingly, if one of the pumps 100 in the rack a pump 100 faults or needs to be taken out of service, another pump 100, that is in a rack 302 but not being used, could receive the full programming and current status of pump 100. All programming and status parameters could be transferred to pump 100. A syringe or other reservoir could be quickly moved from pump to pump with very little delay in therapy and no loss of data. A location in the rack 302 could be designated as the spare pump spot. A fault in any other pump 100 in the rack 302 could cause the medical device controller to program the spare pump 100 so that it can be quickly swapped with the pump 100 that has faulted.
  • methods, systems, and software for downloading, editing, and/or integrating drug delivery profiles or segments of profiles for infusion pumps may allow for complex delivery patterns. It is further to be appreciated and understood that any of the aforementioned delivery profiles or segments of delivery profiles can be stored and/or performed in the infusion pump itself or a computer server, in the pump internally or separately or otherwise remotely from the pump. Further, it is to be appreciated that the aforementioned delivery profiles or segments of delivery profiles can be created by or with outside software or systems and subsequently downloaded to or integrated with the systems and software described herein.

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Abstract

Des modes de réalisation de la présente invention concerne un système de clonage localisé d'une pluralité de dispositifs médicaux enfants présentant des paramètres de fonctionnement commun avec un dispositif médical parent. Le système comprend un bâti comprenant une pluralité de structures de montage configurées pour s'accoupler physiquement et de manière amovible à une pluralité de dispositifs médicaux enfants et de dispositifs médicaux parents. Le système comprend également un bus de communication numérique prévu sur le bâti qui permet la communication entre le dispositif médical parent et la pluralité de dispositifs médicaux enfants qui sont accouplés au bâti. De manière additionnelle, le dispositif médical parent règle un ou plusieurs paramètres de fonctionnement de la pluralité de dispositifs médicaux enfants avec des communications envoyées par l'intermédiaire du bus de communication numérique.
PCT/US2017/042633 2016-07-25 2017-07-18 Clonage de configurations de dispositif médical Ceased WO2018022355A1 (fr)

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US11167081B2 (en) 2016-06-16 2021-11-09 Smiths Medical Asd, Inc. Assemblies and methods for infusion pump system administration sets
WO2019018658A2 (fr) 2017-07-19 2019-01-24 Smiths Medical Asd, Inc. Agencements de boîtier pour pompes à perfusion
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