EP4701681A1 - Device, method, and system for automated preconditioning of a syringe during bolus delivery of a fluid - Google Patents

Device, method, and system for automated preconditioning of a syringe during bolus delivery of a fluid

Info

Publication number
EP4701681A1
EP4701681A1 EP23725499.0A EP23725499A EP4701681A1 EP 4701681 A1 EP4701681 A1 EP 4701681A1 EP 23725499 A EP23725499 A EP 23725499A EP 4701681 A1 EP4701681 A1 EP 4701681A1
Authority
EP
European Patent Office
Prior art keywords
bolus
syringe
sub
cycles
syringe pump
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.)
Pending
Application number
EP23725499.0A
Other languages
German (de)
French (fr)
Inventor
Vinay JANI
Alex William PINCHBECK
Adonis Esahi GLASPER
Leo Alexander LORENZETTI
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.)
CareFusion 303 Inc
Original Assignee
CareFusion 303 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 CareFusion 303 Inc filed Critical CareFusion 303 Inc
Publication of EP4701681A1 publication Critical patent/EP4701681A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1456Pressure 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16804Flow controllers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body electrical or electronic

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

Abstract

Automated preconditioning of a syringe during bolus delivery of a fluid is described. A syringe pump controller receives a command for the syringe pump to perform a bolus of fluid, determines that the syringe should be preconditioned for the bolus, determines a characteristic of the syringe delivering the fluid, determines a number of bolus sub-cycles of the bolus to perform the bolus based on a determined characteristic of the syringe, and performs the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe.

Description

DEVICE, METHOD, AND SYSTEM FOR AUTOMATED PRECONDITIONING OF A SYRINGE DURING BOLUS DELIVERY OF A FLUID
TECHNICAL FIELD
[0001] The present disclosure is related generally to delivery of a fluid bolus from a syringe pump.
BACKGROUND
[0002] The infusion of medical fluids, such as parenteral fluids, into the human body is accomplished in many cases by means of a syringe pump in which a syringe containing the parenteral fluid is mounted. Syringe pumps typically secure the barrel in a fixed position and utilize a drive head to push or “drive” the plunger into the barrel at a controlled rate to expel the fluid. Loading boluses - i.e., a first bolus delivered on an unused intravenous (IV) set - has been found to have highly variable and relatively poor performance. This performance is even further degraded in low bolus volumes.
SUMMARY
[0003] The subject technology provides a syringe pump comprising a receptacle for loading a syringe, the syringe comprising a barrel and a plunger; and a controller, the controller configured to: receive a command for the syringe pump to perform a bolus of fluid, the syringe pump configured to deliver the fluid through an infusion line by way of advancing the plunger into a barrel of the syringe when loaded in the receptacle; determine that the syringe should be preconditioned for the bolus; determine a characteristic of the syringe; determine a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic, each bolus sub-cycle comprising advancing the plunger a division of a total distance required to complete the bolus and then stopping before the plunger further advanced to complete the bolus; and perform, responsive to the command, the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe. Other aspects include corresponding methods, systems, and computer program products for implementation of the corresponding syringe pump and its features.
[0004] A machine-implemented method comprises: receiving, by a syringe pump, a command for the syringe pump to perform a bolus of fluid, the syringe pump configured to deliver the fluid through an infusion line by way of advancing a plunger into a barrel of a syringe loaded in the syringe pump; determining that the syringe should be preconditioned for the bolus; determining a characteristic of the syringe; determining a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic, each bolus sub-cycle comprising advancing the plunger a division of a total distance required to complete the bolus and then stopping before the plunger further advanced to complete the bolus; and performing, responsive to the command, the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe. Other aspects include corresponding systems, apparatus, and computer program products for implementation of the corresponding method and its features.
[0005] While the methods and systems disclosed herein are described with regard to syringe pumps, the subject technology is applicable to all infusion pumps. For example, the methods are capable of detecting whether a container volume supplying an infusion fluid (e.g., the medication) is empty. It is understood that other configurations of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0006] For a better understanding of the various described implementations, reference should be made to the Description below, in conjunction with the following drawings. Like reference numerals refer to corresponding parts throughout the figures and description.
[0007] FIG. 1 depicts an example patient care system that includes a syringe pump mounted to a control unit, according to various aspects of the subject technology.
[0008] FIG. 2 depicts a first example syringe pump for use in the patient care system of FIG. 1, according to various aspects of the subject technology.
[0009] FIG. 3 depicts a second example syringe pump, according to various aspects of the subject technology. [0010] FIG. 4A and 4B depict example hysteresis and bolus preconditioning for an example representative syringe, and FIG. 4C depicts an example preconditioning of a syringe by the syringe pump in accordance with FIG. 4B, according to various aspects of the subject technology.
[0011] FIG. 5 depicts an example process for automated preconditioning of a syringe during a bolus delivery of a fluid, according to aspects of the subject technology.
[0012] FIG. 6 is a conceptual diagram illustrating an example electronic system for preconditioning a syringe for bolus delivery, according to aspects of the subject technology.
DESCRIPTION
[0013] Reference will now be made to implementations, examples of which are illustrated in the accompanying drawings. In the following description, numerous specific details are set forth in order to provide an understanding of the various described implementations. However, it will be apparent to one of ordinary skill in the art that the various described implementations may be practiced without these specific details. In other instances, well-known methods, procedures, components, circuits, and networks have not been described in detail so as not to unnecessarily obscure aspects of the implementations.
[0014] In today's syringe-based infusion systems, the very first bolus delivered from the pump has the worst performance, which becomes even worse as the size of the barrel increases. The subject technology solves this problem by dividing the first bolus delivered from a syringe disposable into multiple sub-boluses instead of a continuous bolus. The pump then automatically initiates the bolus by initiating a plurality of smaller, sub-boluses to precondition the syringe for the bolus, iteratively generating a force and then stopping delivery of the fluid for each sub-bolus within the delivered bolus.
[0015] The number of sub-boluses delivered during a particular bolus may vary depending on characteristics of the syringe, the fluid within the syringe, and the amount of bolus requested. According to various aspects, the preconditioning bolus may be a bolus delivered as part of priming the intravenous (IV) tubing. In some implementations, each bolus may be divided into to sub-boluses, with the number of sub-boluses in each bolus decreasing with each bolus as the syringe becomes conditioned. Sub-boluses may be a series of short boluses, or may be long then short, or short than long. In some implementations, the number of sub-boluses is predetermined for each size syringe. In some implementations, the pump monitors the amount of force delivered for each sub-bolus and adjusts the number of sub-boluses in real time during each bolus operation.
[0016] High variability and poor performance increase patient risk, especially for life sustaining drugs and sensitive patient population. By breaking the bolus into sub-boluses and delivering the sub-bolus as part of the bolus, the syringe becomes conditioned and more accurate, and safety is promoted. In this manner, the syringe pump safely administers a bolus to a patient with minimal deviation from the intended amount of fluid to be delivered.
[0017] FIG. 1 depicts an example patient care system 122 that includes a syringe pump 30 mounted to a control unit 14, according to various aspects of the subject technology. According to various implementations, the control unit 14 may provide control and monitoring functionality for the syringe pump 30. In this regard, the control unit may include a display 4 for visually communicating various information, such as the operating parameters of a connected pump and alert indications and alert messages, and control keys 6 for selecting and/or setting control parameters and/or options for controlling connected modules such as syringe pump 30. The control unit 30 may also include a speaker to provide audible alerts. In some implementations, the display 4 may be implemented as a touchscreen display. In such implementations, the control keys 6 may be omitted or reduced in number by providing corresponding interactive elements via a graphical user interface presented via the display 4. In some implementations, each control key 6 may select a corresponding option displayed in display 4.
[0018] The syringe pump 30 can include a control panel 76 providing multiple buttons 78 for control of the pump 26 as well as a display 80 used to present pump-specific information to the operator (see also FIG. 2). The buttons 78 can allow the operator to program the pump 26 for the flow rate, the volume to be infused, and other pump parameters. The display 80 can present the programmed flow rate, the amount of fluid remaining to be infused, as well as alarms and other information.
[0019] The control unit 14 may include a communications system (not shown) with which the control unit 14 may communicate with external equipment such as a medical facility server or other computer and with a portable processor, such as a handheld communication device or a laptop-type of computer, or other information device that a clinician may have to transfer information as well as to download drug libraries to a control unit (such as pump 30 or, e.g., modules of FIG. 4). The communication module may be used to transfer access and interaction information for clinicians encountering the control unit or device coupled therewith (e.g., pump 30 or bar code scanner). The communications system may include one or more of a radio frequency (RF) system, an optical system such as infrared, a BLUETOOTH™ system, or other wired or wireless system. The bar code scanner and communications system may alternatively be included integrally with the infusion pump 30, such as in cases where a control unit is not used, or in addition to one with the control unit 14. Further, information input devices need not be hard-wired to medical instruments, information may be transferred through a wireless connection as well. Additionally, other types of modules may be connected to the pump modules or to the control unit such as a syringe pump module, patient controlled analgesic module, End Tidal CO2 monitoring module, oximeter monitoring module, or the like.
[0020] In some embodiments, the pressure measurements from the upstream and/or downstream pressure sensors are transmitted to a server or other coordination device, and the methods disclosed herein are implemented on the server or other coordination device. For example, a pressure sensor may be used to determine a pressure or force within the infusion line downstream of the pump (e.g., between the patient and the pump). More sophisticated and computationally intensive approaches like machine-learning can be implemented on a server (or on a control unit with a larger memory and/or CPU resources). In some embodiments, machine learning is used to identify empty conditions based on pressure signals received from the pump.
[0021] FIG. 2 depicts an example syringe pump infusion system including a first example syringe pump 30, according to various aspects of the subject technology. Syringe pumps can be used for the infusion of medical fluids, such as parenteral fluids, into the human body. In many cases, smooth delivery of medical fluids is desired. For example, where the medical fluid includes a medication, delivery at a consistent or predicable flow rate allows a medical professional to properly plan and execute a treatment. Mechanical interactions between parts of an infusion system can produce resistance to smooth delivery. Aspects of the embodiments discloses herein address these concerns to provide more consistent and predictable flow during driver operation.
[0022] According to various implementations, the depicted infusion syringe pump 30 includes a drivetrain subsystem. A syringe 32 is shown next to the pump rather than mounted in the pump, for clarity of illustration. The syringe pump 30 includes a cradle/receptacle 34 in which a barrel 236 can rest when mounted in the syringe pump 30. The cradle 34 can include a clamp 38 to securely hold the barrel 36 in a fixed position in the cradle 34 so that axial and lateral movement is resisted. The clamp 38 can be pivoted so that it may be moved into an open position to permit loading or removal of the syringe 32 and a closed position in which it extends over the cradle 34 to hold a mounted barrel 36. A barrel flange 40 of the syringe 32 can be located in a barrel flange groove 42 in the syringe pump 30 to immobilize the barrel 36 from axial movement during movement of the plunger 44 within the barrel 36.
[0023] The syringe 32 can include the barrel 36 and the plunger 44. The plunger 44 can include a push-button 46 having an inner side 48 and being interconnected with a stopper 62 of the plunger 44 by a piston 50. The plunger 44 can include the stopper 62 to sealingly engage an inner wall of the barrel 36 to prevent fluid from leaking past the stopper 62. When mounted in the syringe pump 30, the push-button 46 can be held by a drive head 54 with a plunger retainer comprising a pair of pivotally mounted claws, first retainer claw 56 and second retainer claw 58, shown in the closed position in FIG. 2. The retainer claws 56 and 58 can curve inwardly toward each other to grasp the push-button 46 when mounted in the syringe pump 30. A rotation knob 64 can be used to control the positions of the first and second retainer claws 56 and 58 to allow removal and insertion of the push-button 46 and to release the split-nut from the driveshaft to permit axial positioning of the drive head 54. Syringes can be provided for use with a syringe pump with different quantities of fluid, and the plunger can be located at different positions in relation to the barrel.
[0024] The drive head 54 may allow manual adjustment to accommodate syringes with different beginning plunger positions. A syringe inserted in the cradle 34 can align with the drive head 54 within a particular axial range. The points where the axial center lines of the syringes intersect the driver can change according to the size of the syringe but only in one direction along the drive head 54. A guide device 65 can extend from the drive head 54 to a point within a body of the syringe pump 30.
[0025] According to some implementations, the system can include components for controlling advancement of the plunger 44 within the barrel 36 of the syringe 32. The drive head 54, which engages the push-button 46 of the syringe 32, can be moved by a drivetrain (not shown). For example, the pump 30 can include a motor that operates to rotate a lead screw engaged by a screw drive mechanism, such as a split nut, that translates the rotational motion of the lead screw into linear motion. The drive head 54 is connected to the screw drive mechanism and drives plunger 44 into the barrel 36 in accordance with the movement of the lead screw to expel fluid from the barrel 36.
[0026] According to some embodiments, the motor may include a stepper motor, a brushed DC electric motor, a brushless DC electric motor, a servo motor, an AC motor, or another type of motor. The drivetrain may include appropriate gears, axles, shafts, chains, hydraulics, and/or any other components for translating rotational motion of the motor into linear motion of the drive head 54. According to some embodiments, the drivetrain, including the motor, can include linear actuating components, such as a linear stepper motor. For example, a linear motor can act directly on the drive head, or a component attached thereto, to control linear motion thereof.
[0027] The drive head 54 can interact with the syringe 32 in a manner that facilitates prompt, consistent, and predicable infusion of a fluid from the syringe 32 to the patient. The features described herein can be used individually or in combination to improve the ability of the system to deliver medication promptly and smoothly at low flow rates.
[0028] In some implementations, the syringe pump 30 includes a cradle sensor positioned in or near the cradle 34. For example, the cradle sensor may be configured to detect whether a syringe is loaded in the cradle. In some implementations, the syringe pump 30 includes a barrel clamp sensor positioned on or near the clamp 38. For example, the barrel clamp sensor 348 may be configured to detect movement of the clamp 310. As another example, the barrel clamp sensor may be configured to detect whether or how tightly the clamp 38 grips the barrel of the syringe 32 (e.g., corresponding to a size of the syringe). As yet another example, the barrel clamp sensor may be configured to detect a degree of displacement of the clamp. A completely displaced clamp may indicate that the clamp is open (e.g., for loading or unloading of a syringe). By contrast, a clamp displaced only slightly from a completely closed position may indicate that the clamp is gripping a syringe (e.g., with the degree of displacement corresponding to a diameter of the syringe).
[0029] In some implementations, the syringe pump 30 includes a drive head sensor positioned on or near the drive head 54. For example, the drive head sensor may be configured to detect movement of the drive head. As another example, the drive head sensor 350 be configured to detect a position of the drive head. The position may be used to detect when the syringe is empty (e.g., the plunger 44 fully inserted). In some implementations, the syringe pump module includes a plunger retainer sensor positioned on or near the retainer claw. For example, the retainer sensor may be configured to detect opening and/or closing of the retainer claw. As another example, the retainer sensor may be configured to detect whether or how tightly the retainer claw grips the push-button of the plunger 44. One or more of the foregoing sensors may be used to detect when a new syringe is being loaded into the syringe pump 30, or when a syringe is being unloaded from the pump. In some implementations, a sensor may be used to optically detect when a syringe is emptied (e.g., by detecting the piston 50 at the end of the barrel 36).
[0030] When loading a syringe 32, a clinician releases and raises up the drive head. Such physical interaction may be detected by the drive head sensor. The clinician may then pull out and/or twist the barrel clamp out of the way, activating the barrel clamp sensor. The clinician loads the syringe and the cradle sensor detects the barrel of syringe when its loaded into the cradle/receptacle. A barrel flange sensor detects the flange when the flange is secured by the barrel flange. The clinician twists the barrel clamp back in place to secure the syringe within the cradle/receptacle 34 and barrel clamp sensor may detect the clamp has secured the syringe 32. The clinician opens the retainer claws and lowers the drive head onto the push-button of the plunger, releasing the claws to secure the plunger as the claws close around the push-button. Such physical interaction may be detected by the drive head sensor and retainer sensor, respectively.
[0031] As depicted in FIG. 1, the syringe pump 30 can be mounted to a control unit 14, together forming a modular patient care system. The control unit may perform various functions for the pump such as programming and communications. Control elements and functions can be included with and performed, at least in part, by the control unit 14. In addition to the syringe pump 30 mounted to the control unit 14, other modules, such as those providing patient monitoring or therapies, can also form part of the patient care system. The control unit 14 can provide a centralized interface for the various attached modules. One or more syringe pumps can be mounted to the control unit 14 and/or each other.
[0032] FIG. 3 depicts a second example syringe pump 30 infusion device, according to various aspects of the subject technology. While the example syringe pump 30 is shown as a stand alone device, the syringe pump may be configured as a functional module of a modular infusion system such as a syringe module for the BD Alaris™ system. [0033] When a syringe 32 is loaded in the syringe pump 30, a plunger flange (or push button) 46 at the end of a syringe plunger piston 44 is held in or against a plunger drive head 54 by a flange clamp 104. The barrel 36 is secured by a syringe clamp 108. The drive head 54 includes a pushing surface on which the plunger flange 46 will rest as the drive head 54 moves forward toward the barrel 36 pushing the plunger piston 44 into the barrel 36 of the syringe to expel the syringe contents through an administration tubing 110 to the patient. As will be described further, the drive head 54 may be connected to a screw drive mechanism, including a motor, for connecting the linear motion of the screw drive mechanism to the syringe plunger in order to empty the syringe. The rate at which the drive head moves may be controlled by the syringe pump 100 based on programmed parameters (e.g., desired rate, type of syringe). In some implementations, the drive head and/or the rate may be controlled externally and/or remotely by a computing device communicating with the syringe pump. As will be described further, the drive head may move in predetermined incremental amounts that together form a total amount to be delivered in a bolus.
[0034] Syringe pumps do not typically experience any upstream pressure conditions because the fluid to be infused is housed in the barrel 106 and is pushed into an administration set 110 by way of the plunger piston 44. Downstream pressure conditions can be detected by a force sensor housed in or upon a pump system 112. In some implementations, a force sensor measures the force exerted by the drive head 54 of the syringe pump on the syringe plunger piston 44.
[0035] In some implementations, the syringe pump 30 may include a high-resolution pressure/force sensor that interfaces with a pressure disc (not shown) on the syringe administration set. The pressure disc provides a relatively large area in contact with the pressure sensor. This allows the pressure sensor to measure the pressure inside the administration set more directly (not through the syringe plunger head) and with higher resolution and higher accuracy compared with the drive head force sensor. The measurements from this pressure sensor and the drive head force sensor can be used independently or in conjunction with each other to detect an empty condition in a syringe pump and/or, as will be described further, to detect when a bolus or bolus sub-cycle is complete.
[0036] As well as operating buttons or switches, which the operator may use to activate and program the syringe pump 100, there is a display screen 114. The display screen 114 may be an LCD (liquid crystal display) having a small number of segments, for example seven segments in a figure-of-eight configuration per character, adapted to display a small number of alphanumeric characters. The display may be monochromatic, for example, it might only display red, green, or grey/black characters. Alternatively, the display 114 can be a more complicated liquid crystal display capable of displaying more characters or more complicated characters. The LCD may be backlit, for example, using light emitting diodes (LEDs). In some implementations, the infusion pump may include a TFT LCD. A TFT is a thin-film transistorbased LCD technology. In some implementations, the display screen 114 is also a touchscreen such as a capacitive touchscreen.
[0037] When programming the syringe pump 30, the user may input the type of syringe being used. The syringe pump 100 may store in an internal memory a database of known syringe types containing information such as syringe diameter and stroke. The infusion pump firmware calculates the position of the syringe plunger and syringe piston based on movement of the syringe drive head and the type and size of the syringe. This allows the machine to display the calculation of volume infused, time elapsed, volume remaining and time remaining. As infusion continues and the drive head moves, these calculations can be updated, and the displayed information changed.
[0038] The syringe pump 30 may be provided with an input interface with controls operable to enter, increase or decrease pumping parameters, such as the mass flow rate setting shown on a display, or the VTBI (volume to be infused) setting shown on the display. In some cases, an input key may be physically present on the device (as depicted) or may be graphically displayed in a touchscreen display 114.
[0039] In some implementations, the syringe pump 30 may be configured to identify (e.g., using a sensor) a disposable container loaded by the device. The syringe pump 30 of FIG. 3 may include one or more (or all) of the same or analogous sensors as discussed above with regard to FIG. 2. In this regard, a processor of the syringe pump (e.g. , internally or in the control unit 14) may detect when the syringe becomes empty (e.g., by using a drive head sensor, piston sensor, or pressure sensor), and when the user is loading or unloading the syringe from the syringe pump.
[0040] The syringe pump 30 may perform electro-mechanical measurements on the loaded syringe to identify certain characteristics about the loaded container. For example, a syringe pump may include a sensor that measures the size of the syringe inserted into the pump, for example, based on how tightly the syringe is being hugged (e.g., by the barrel clamp). The clock position may determine the size of the barrel (e.g., whether it is a 6, 10, 50 ml syringe, etc.). Based on the physical measurements made by the pump, the syringe pump may determine a list of possible candidate syringes. The device may then request confirmation via the display whether the container is within that list. During the infusion, volume infused and/or flow rate may be calculated based on the syringe type (e.g., based on the size of the barrel).
[0041] FIG. 4A and 4B depict example hysteresis and bolus preconditioning for an example representative syringe, according to aspects of the subject technology. As depicted in FIG. 4A, some syringes are not purely elastic; energy can be dissipated when a load is applied and then removed. The force of a bolus (402) places a load on the syringe, causing increased stress and strain. When the bolus stops (404), energy is lost (406). Repeated boluses can be thought of as loading and unloading events. The energy is lost due to non-elastic effects of the syringe, and less energy is transferred to the fluid. In the case of the syringe pump 30, force is constant from the drive head 54. According to various implementations, less energy may be transferred to the fluid and the rate may become inaccurate.
[0042] As the size of the syringe increases so does its error potential. For example, a 3 mL syringe may have a mean error in its bolus delivery of ~5%, whereas a 20 mL syringe may have a mean error of ~25% and a 50 mL syringe may have a mean error of ~67% under similar conditions. Such errors may impact delivery of medication from a syringe in view of the expected results in a clinical setting.
[0043] As depicted in FIG. 4B, it has been discovered that the highest energy lost occurs in the first load and unload cycle (408). Preconditioning of the syringe 32 may include the application of multiple load and unload cycles, also called bolus sub-cycles 410 herein. As more load and unload events occur, the syringe reaches a steady state of energy lost (412). Because energy loss decreases after the first several load and unload events, the subject technology may apply a limited number of preconditioning sub-cycles 410 (start and stop) during a bolus, and then either reduce the number, or eliminate, the sub-cycles for subsequent boluses.
[0044] According to various implementations, the subject technology may precondition a syringe by applying multiple low volume bolus cycles to the syringe at a high rate to more effectively break the syringe in. Testing results have shown that such preconditioning can provide a more consistent performance and notable reductions in variability in loading bolus accuracy.
[0045] FIG. 4C depicts an example preconditioning of a syringe by the syringe pump 30 in accordance with FIG. 4B, according to various aspects of the subject technology. The controller associated with syringe pump 30 is configured to move the drive head 54 incrementally and/or at high speeds during a bolus. In this regard, the drive head 54 moves to push 414 the plunger 44 of the syringe 32 incrementally in steps to generate a plurality of bolus sub-cycles 410i-x.
[0046] In the depicted example, each bolus sub-cycle 410 nx includes advancing the plunger a division of a total distance required to complete the bolus. In other words, each bolus subcycle 410i-x delivers a portion of a total volume of the bolus and then pauses delivery before a next/ subsequent bolus sub-cycle. For example, instead of delivering a 1 mL bolus of fluid, the subject technology divides the total target amount (1 mL) into smaller volumes that add up to the target amount (1 mL). It is understood that, while FIG. 4C may appear to depict advancing the plunger 44 the entire length of the syringe chamber 416 to deliver a bolus, the bolus amount may correspond to a portion of the chamber and the depicted sub-cycles 410 may span only the portion of the chamber 416 corresponding to the bolus amount. While FIG. 4 depicts several short bolus sub-cycles followed by a long sub-cycle 41 Ox, it is understood that the sub-cycles may be made up of a series of boluses of different bolus amounts and/or durations, including short boluses, or long then short, or short than long.
[0047] FIG. 5 depicts an example process 500 for automated preconditioning of a syringe during a bolus delivery of a fluid, according to aspects of the subject technology. For explanatory purposes, the various blocks of example process 500 are described herein with reference to FIGS. 1-4C, and the components and/or processes described herein. The one or more of the blocks of process 500 may be implemented, for example, by one or more computing devices including, for example, control unit 14 or internal processor of the syringe pump. In some implementations, one or more of the blocks may be implemented based on one or more machine learning algorithms. In some implementations, one or more of the blocks may be implemented apart from other blocks, and by one or more different processors or devices. Further for explanatory purposes, the blocks of example process 500 are described as occurring in serial, or linearly. However, multiple blocks of example process 500 may occur in parallel. In addition, the blocks of example process 500 need not be performed in the order shown and/or one or more of the blocks of example process 500 need not be performed.
[0048] As previously described with regard to FIGS. 2, 3 and 4C, a syringe may be loaded into a receptacle of a syringe pump 30, and attached to an intravenous (IV) set 110 for delivery of fluids to a patient. The syringe pump 30 is configured to deliver the fluid through the IV line by way of advancing a plunger 44 into a barrel 36 of the syringe when loaded in the receptacle of the pump. According to various implementations, the syringe pump 30 may have an auto-prime function by which a clinician is instructed by the pump to attach the IV set to the pump but not to the patient, and to engage an auto-prime control. The auto-prime control of the pump initiates a bolus into the line to prime the line. According to various other implementations, the clinician may initiate a bolus by specifically programming the bolus at the pump interface.
[0049] In the depicted example, a controller associated with the syringe pump 30 (e.g., onboard the pump, in a control unit 14, or a server or other remotely connected computing device associated with control of the pump) receives receive a command for the syringe pump to perform a bolus of fluid (502). The amount of fluid of the bolus may be programmed by the clinician or may be predetermined (e.g., as part of auto-priming). Before initiating the bolus, the controller determines whether the syringe should be preconditioned (504) (e.g., to increase accuracy and efficacy of the delivery). The preconditioning determination may be based on the pump determining that another bolus has not been delivered from the current syringe loaded into the pump prior to the bolus for which the command was received. In some implementations, the determination may be based on the pump having been idle for a predetermined period of time (e.g., 30 minutes or an hour). The determination may be based on a combination of these factors or other data related to the syringe, pump, patient, or fluids administered to be administered thereby that is accessible to the pump. If the pump determines that no preconditioning should be performed then the programmed bolus is performed without preconditioning (506).
[0050] To appropriately calibrate the pump for syringe preconditioning, the controller determines a characteristic of the syringe (508). The characteristic may include, for example, a size of the syringe, type of syringe, or a manufacturer or part number of the syringe. The characteristic may be input by the clinician using a user interface of the syringe pump (e.g., touch screen 4, 114, key entry 6, 78, etc.) or may be received from a remote device such as a mobile device (e.g., associated with a clinician) paired with the pump or a remotely connected server (e.g., an EMR server).
[0051] In some implementations, as described previously, the syringe pump 30 may automatically determine the characteristic (e.g., size) of the syringe based on sensor measurements and/or may prompt the user to confirm the characteristic (e.g., size) or select the characteristic by way of selecting from a list of characteristics and/or syringes. The candidate list of characteristics and/or syringes may be determined automatically based on indexing a database based on a detected size and/or a medication identification associated with the current infusion. Any characteristic of the syringe may be determined based on indexing a database based on other characteristics (e.g., the size of the syringe may be determined based on the type of syringe and vice versa). Characterizing the syringe may not be based on determining whether a preconditioning should be made; a syringe may be characterized at any point during the infusion process.
[0052] The controller determines a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic (510). According to various implementations, with brief reference to FIG. 4C, each bolus sub-cycle delivers a portion of a total volume of the bolus and then the pump pauses delivery before a next/subsequent bolus sub-cycle is performed. In this regard, each bolus sub-cycle may include advancing the plunger a division of a total distance required to complete the bolus, stopping, and then further advancing the plunger further divisions to complete the bolus.
[0053] In some implementations, the controller determines the number of bolus sub-cycles of the bolus based on indexing a table based on the determined characteristic. The determined number of bolus sub-cycles may be, for example, proportional to the syringe size such that a first syringe size is determined to have a greater number of bolus sub-cycles than a second syringe size when the first syringe size is larger than the second syringe size. In various implementations, the size may be determined based on the type of syringe, part number, and the like. In some implementations, the number of bolus sub-cycles may be determined based on any characteristic of the syringe (e.g., by indexing a database based on the characteristic).
[0054] The controller, responsive to the command, performs the bolus by performing the number of bolus sub-cycles during the bolus to precondition the syringe for the bolus (512). As described previously, the sub-cycles may be made up of a series of boluses of different bolus amounts and/or durations, including short boluses, or long then short, or short than long. In one example, an initial bolus sub-cycle of the number of bolus sub-cycles may be performed for a longer duration or greater volume than subsequent bolus sub-cycles of the number of bolus sub-cycles. In some implementations, the pump will perform a series of short boluses followed by a bolus of a longer duration (e.g., the remaining amount of the fluid programmed for the bolus).
[0055] In some implementations, the bolus in initiated before the number of bolus subcycles is determined. In this regard, the bolus may be initiated and the number of bolus subcycles (and duration of each sub-cycle) determined while performing the bolus. In some implementations, the controller may determine, based on the determined characteristic, a force required for at least one sub-cycle, monitor a force of the bolus using a force sensor associated with the syringe pump, and perform each bolus sub-cycle until a threshold force is measured by the force sensor during the at least one sub-cycle. In some implementations, the controller completes the bolus when a force measured for a respective bolus sub-cycle of the number of bolus sub-cycles is less than a force measured for two or more bolus sub-cycles performed prior to the respective bolus sub-cycle.
[0056] In some implementations, the controller determines, based on the determined characteristic, a force delta threshold and monitors a force of each bolus sub-cycle that is performed by the syringe pump using a force sensor associated with the syringe pump. The bolus may then be completed when a variance between a force measured by the force sensor for a first set of (one or more) consecutive bolus sub-cycles and a force measured by the force sensor for a second subsequent set of (one or more) consecutive bolus sub-cycles satisfies the force delta threshold. In some implementations, the force delta threshold is determined by the controller based on the determined characteristic (e.g., by indexing the database based on the type, size, manufacturer, or part number of the syringe).
[0057] In some implementations, the syringe pump determines a syringe should be preconditioned for bolus delivery (e.g., again) because the syringe pump has been in an idle state for a period of time. For example, the controller may determine that the syringe pump has been in an idle state, with the syringe being loaded, for a predetermined period of time. The controller determines the number of bolus sub-cycles and performs the bolus, after determining that the syringe pump has been in the idle state. [0058] As described previously, the command may be a command to prime the infusion line. In this regard, the controller may determine whether the IV set comprises a priming cap. The controller may prompt the clinician to confirm use of the priming cap on the IV set. In some implementations, the syringe pump may use a force detector to detect the prime cap by initiating a small bolus to determine a force within the line. If the measured force corresponds to a force for detection of a priming cap then the use of the priming cap may be confirmed. When the priming cap is detected and/or confirmed, the controller may determine a threshold force for determining that the bolus is complete (and/or that a respective sub-cycle is complete). Accordingly, the controller may automatically complete the bolus when the force sensor measures the determined threshold force.
[0059] Many of the above-described example process 600, and related features and applications, may also be implemented as software processes that are specified as a set of instructions recorded on a computer readable storage medium (also referred to as computer readable medium), and may be executed automatically (e.g., without user intervention). When these instructions are executed by one or more processing unit(s) (e.g., one or more processors, cores of processors, or other processing units), they cause the processing unit(s) to perform the actions indicated in the instructions. Examples of computer readable media include, but are not limited to, CD-ROMs, flash drives, RAM chips, hard drives, EPROMs, etc. The computer readable media does not include carrier waves and electronic signals passing wirelessly or over wired connections.
[0060] The term “software” is meant to include, where appropriate, firmware residing in read-only memory or applications stored in magnetic storage, which can be read into memory for processing by a processor. Also, in some implementations, multiple software aspects of the subj ect disclosure can be implemented as sub-parts of a larger program while remaining distinct software aspects of the subject disclosure. In some implementations, multiple software aspects can also be implemented as separate programs. Finally, any combination of separate programs that together implement a software aspect described here is within the scope of the subject disclosure. In some implementations, the software programs, when installed to operate on one or more electronic systems, define one or more specific machine implementations that execute and perform the operations of the software programs.
[0061] A computer program (also known as a program, software, software application, script, or code) can be written in any form of programming language, including compiled or interpreted languages, declarative or procedural languages, and it can be deployed in any form, including as a stand-alone program or as a module, component, subroutine, object, or other unit suitable for use in a computing environment. A computer program may, but need not, correspond to a file in a file system. A program can be stored in a portion of a file that holds other programs or data (e.g., one or more scripts stored in a markup language document), in a single file dedicated to the program in question, or in multiple coordinated files (e.g., files that store one or more modules, sub programs, or portions of code). A computer program can be deployed to be executed on one computer or on multiple computers that are located at one site or distributed across multiple sites and interconnected by a communication network.
[0062] FIG. 6 is a conceptual diagram illustrating an example electronic system 600 for automated preconditioning of a syringe during a bolus delivery of a fluid, according to aspects of the subject technology. Electronic system 600 may be a computing device for execution of software associated with one or more portions or steps of method 600, or components and methods provided by FIGS. 1-5, including but not limited to computing hardware within syringe pump 30, control unit 14, and/or any computing devices or associated terminals associated with the syringe pump and/or control unit to control and/or operate the same. In this regard, electronic system 600 may be a personal computer or a mobile device such as a smartphone, tablet computer, laptop, PDA, an augmented reality device, a wearable such as a watch or band or glasses, or combination thereof, or other touch screen or television with one or more processors embedded therein or coupled thereto, or any other sort of computer-related electronic device having network connectivity.
[0063] Electronic system 600 may include various types of computer readable media and interfaces for various other types of computer readable media. In the depicted example, electronic system 600 includes a bus 608, processing unit(s) 612, a system memory 604, a readonly memory (ROM) 610, a permanent storage device 602, an input device interface 614, an output device interface 606, and one or more network interfaces 616. In some implementations, electronic system 600 may include or be integrated with other computing devices or circuitry for operation of the various components and methods previously described.
[0064] Bus 608 collectively represents all system, peripheral, and chipset buses that communicatively connect the numerous internal devices of electronic system 600. For instance, bus 408 communicatively connects processing unit(s) 612 with ROM 610, system memory 604, and permanent storage device 602. [0065] From these various memory units, processing unit(s) 612 retrieves instructions to execute and data to process in order to execute the processes of the subject disclosure. The processing unit(s) can be a single processor or a multi-core processor in different implementations .
[0066] ROM 610 stores static data and instructions that are needed by processing unit(s) 612 and other modules of the electronic system. Permanent storage device 602, on the other hand, is a read-and-write memory device. This device is a non-volatile memory unit that stores instructions and data even when electronic system 600 is off. Some implementations of the subject disclosure use a mass-storage device (such as a magnetic or optical disk and its corresponding disk drive) as permanent storage device 602.
[0067] Other implementations use a removable storage device (such as a floppy disk, flash drive, and its corresponding disk drive) as permanent storage device 602. Like permanent storage device 602, system memory 604 is a read-and-write memory device. However, unlike storage device 602, system memory 604 is a volatile read-and-write memory, such a random access memory. System memory 604 stores some of the instructions and data that the processor needs at runtime. In some implementations, the processes of the subject disclosure are stored in system memory 604, permanent storage device 602, and/or ROM 610. From these various memory units, processing unit(s) 612 retrieves instructions to execute and data to process in order to execute the processes of some implementations.
[0068] Bus 608 also connects to input and output device interfaces 614 and 606. Input device interface 614 enables the user to communicate information and select commands to the electronic system. Input devices used with input device interface 614 include, e.g., alphanumeric keyboards and pointing devices (also called “cursor control devices”). Output device interfaces 606 enables, e.g., the display of images generated by the electronic system 600. Output devices used with output device interface 606 include, e.g., printers and display devices, such as cathode ray tubes (CRT) or liquid crystal displays (LCD). Some implementations include devices such as a touchscreen that functions as both input and output devices.
[0069] Also, as shown in FIG. 6, bus 608 also couples electronic system 600 to a network (not shown) through network interfaces 616. Network interfaces 616 may include, e.g., a wireless access point (e.g., Bluetooth or WiFi) or radio circuitry for connecting to a wireless access point. Network interfaces 616 may also include hardware (e.g., Ethernet hardware) for connecting the computer to a part of a network of computers such as a local area network (“LAN”), a wide area network (“WAN”), wireless LAN, or an Intranet, or a network of networks, such as the Internet. Any or all components of electronic system 600 can be used in conjunction with the subject disclosure.
[0070] These functions described above can be implemented in computer software, firmware or hardware. The techniques can be implemented using one or more computer program products. Programmable processors and computers can be included in or packaged as mobile devices. The processes and logic flows can be performed by one or more programmable processors and by one or more programmable logic circuitry. General and special purpose computing devices and storage devices can be interconnected through communication networks.
[0071] Some implementations include electronic components, such as microprocessors, storage and memory that store computer program instructions in a machine-readable or computer-readable medium (also referred to as computer-readable storage media, machine- readable media, or machine-readable storage media). Some examples of such computer- readable media include RAM, ROM, read-only compact discs (CD-ROM), recordable compact discs (CD-R), rewritable compact discs (CD-RW), read-only digital versatile discs (e.g., DVD- ROM, dual-layer DVD-ROM), a variety of recordable/rewritable DVDs (e.g., DVD-RAM, DVD-RW, DVD+RW, etc.), flash memory (e.g., SD cards, mini-SD cards, micro-SD cards, etc.), magnetic and/or solid state hard drives, read-only and recordable Blu-Ray® discs, ultra density optical discs, any other optical or magnetic media, and floppy disks. The computer- readable media can store a computer program that is executable by at least one processing unit and includes sets of instructions for performing various operations. Examples of computer programs or computer code include machine code, such as is produced by a compiler, and files including higher-level code that are executed by a computer, an electronic component, or a microprocessor using an interpreter.
[0072] While the above discussion primarily refers to microprocessor or multi-core processors that execute software, some implementations are performed by one or more integrated circuits, such as application specific integrated circuits (ASICs) or field programmable gate arrays (EPGAs). In some implementations, such integrated circuits execute instructions that are stored on the circuit itself. [0073] As used in this specification and any claims of this application, the terms “computer”, “server”, “processor”, and “memory” all refer to electronic or other technological devices. These terms exclude people or groups ofpeople. For the purposes ofthe specification, the terms display or displaying means displaying on an electronic device. As used in this specification and any claims of this application, the terms “computer readable medium” and “computer readable media” are entirely restricted to tangible, physical objects that store information in a form that is readable by a computer. These terms exclude any wireless signals, wired download signals, and any other ephemeral signals.
[0074] To provide for interaction with a user, implementations of the subject matter described in this specification can be implemented on a computer having a display device, e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, for displaying information to the user and a keyboard and a pointing device, e.g., a mouse or a trackball, by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; e.g., feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; e.g., by sending web pages to a web browser on a user’s client device in response to requests received from the web browser.
[0075] Embodiments of the subject matter described in this specification can be implemented in a computing system that includes a back end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back end, middleware, or front end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an internetwork (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
[0076] The computing system can include clients and servers. A client and server are generally remote from each other and may interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some embodiments, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.
[0077] Those of skill in the art would appreciate that the various illustrative blocks, modules, elements, components, methods, and algorithms described herein may be implemented as electronic hardware, computer software, or combinations of both. To illustrate this interchangeability of hardware and software, various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. The described functionality may be implemented in varying ways for each particular application. Various components and blocks may be arranged differently (e.g., arranged in a different order, or partitioned in a different way) all without departing from the scope of the subject technology.
[0078] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
[0079] Illustration of Subject Technology as Clauses:
[0080] Various examples of aspects of the disclosure are described as numbered clauses (1, 2, 3, etc.) for convenience. These are provided as examples, and do not limit the subject technology. Identifications of the figures and reference numbers are provided below merely as examples and for illustrative purposes, and the clauses are not limited by those identification
[0081] Clause 1. A syringe pump, comprising: a receptacle for loading a syringe, the syringe comprising a barrel and a plunger; and a controller, the controller configured to: receive a command for the syringe pump to perform a bolus of fluid, the syringe pump configured to deliver the fluid through an infusion line by way of advancing the plunger into a barrel of the syringe when loaded in the receptacle; determine that the syringe should be preconditioned for the bolus; determine a characteristic of the syringe; determine a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic, each bolus sub-cycle comprising advancing the plunger a division of a total distance required to complete the bolus and then stopping before the plunger further advanced to complete the bolus; and perform, responsive to the command, the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe.
[0082] Clause 2. The syringe pump of Clause 1 , wherein the number of bolus sub-cycles is determined before performing the bolus, the controller further configured to: determine the number of bolus sub-cycles of the bolus to perform the bolus based on indexing a table based on the determined characteristic.
[0083] Clause 3. The syringe pump of Clause 1 , wherein the number of bolus sub-cycles is determined while performing the bolus, the controller further configured to: determine, based on the determined characteristic, a force required for at least one sub-cycle; monitor a force of the bolus using a force sensor associated with the syringe pump; and perform each bolus sub-cycle until a threshold force is measured by the force sensor during the at least one sub-cycle.
[0084] Clause 4. The syringe pump of Clause 3, the controller further configured to: complete the bolus when a force measured for a respective bolus sub-cycle of the number of bolus sub-cycles is less than a force measured for two or more bolus sub-cycles performed prior to the respective bolus sub-cycle.
[0085] Clause 5. The syringe pump of Clause 3 or Claim 4, wherein receiving the command comprises receiving a command to prime the infusion line, the controller further configured to: determine whether the infusion line comprises a priming cap; determine the threshold force based on whether the infusion line comprises the priming cap; and automatically complete the bolus when the force sensor measures the threshold force.
[0086] Clause 6. The syringe pump of any one of Clauses 1 and 2 to 5, wherein the number of bolus sub-cycles is determined while performing the bolus, the controller further configured to: determine, based on the determined characteristic, a force delta threshold; monitor a force of each bolus sub-cycle that is performed by the syringe pump using a force sensor associated with the syringe pump; and complete the bolus when a variance between a force measured by the force sensor for a first set of consecutive bolus sub-cycles and a force measured by the force sensor for a second subsequent set of consecutive bolus sub-cycles satisfies the force delta threshold.
[0087] Clause 7. The syringe pump of any one of Clauses 1 to 6, the controller further configured to: determine that another bolus has not been delivered from the syringe to a patient prior to the bolus for which the command was received, or that the syringe pump has been in an idle state, with the syringe being loaded, for a predetermined period of time; and determine the number of bolus sub-cycles and performing the bolus, after determining that the other bolus has not been delivered or that the syringe pump has been in the idle state.
[0088] Clause 8. The syringe pump of any one of Clauses 1 to 7, wherein determining characteristic of the syringe comprises: receiving a user input of a syringe type or a syringe size.
[0089] Clause 9. The syringe pump of Clause 8, wherein the determined number of bolus sub-cycles is proportional to the syringe size such that a first syringe size is determined to have a greater number of bolus sub-cycles than a second syringe size when the first syringe size is larger than the second syringe size.
[0090] Clause 10. The syringe pump of any one of Clauses 1 to 9, wherein performing the bolus comprises: performing an initial bolus sub-cycle of the number of bolus sub-cycles for a longer duration or greater volume than subsequent bolus sub-cycles of the number of bolus sub-cycles.
[0091] Clause 11. A method performed by a syringe pump, comprising: receiving, by a syringe pump, a command for the syringe pump to perform a bolus of fluid, the syringe pump configured to deliver the fluid through an infusion line by way of advancing a plunger into a barrel of a syringe loaded in the syringe pump; determining that the syringe should be preconditioned for the bolus; determining a characteristic of the syringe; determining a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic, each bolus sub-cycle comprising advancing the plunger a division of a total distance required to complete the bolus and then stopping before the plunger further advanced to complete the bolus; and performing, responsive to the command, the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe. [0092] Clause 12. The method of Clause 11, wherein the number of bolus sub-cycles is determined before performing the bolus, the method further comprising: determining the number of bolus sub-cycles of the bolus to perform the bolus based on indexing a table based on the determined characteristic.
[0093] Clause 13. The method of Clause 11, wherein the number of bolus sub-cycles is determined while performing the bolus, the method further comprising: determining, based on the determined characteristic, a force required for at least one sub-cycle; monitoring a force of the bolus using a force sensor associated with the syringe pump; and performing each bolus sub-cycle until a threshold force is measured by the force sensor during the at least one sub-cycle.
[0094] Clause 14. The method of Clause 13, further comprising: completing the bolus when a force measured for a respective bolus sub-cycle of the number of bolus sub-cycles is less than a force measured for two or more bolus sub-cycles performed prior to the respective bolus sub-cycle.
[0095] Clause 15. The method of any one of Clauses 11, 13, and 15, wherein the number of bolus sub-cycles is determined while performing the bolus, the method further comprising: determining, based on the determined characteristic, a force delta threshold; monitoring a force of each bolus sub-cycle that is performed by the syringe pump using a force sensor associated with the syringe pump; and completing the bolus when a variance between a force measured by the force sensor for a first set of consecutive bolus sub-cycles and a force measured by the force sensor for a second subsequent set of consecutive bolus sub-cycles satisfies the force delta threshold.
[0096] Clause 16. The method of any one of Clauses 11 to 15, further comprising: determining that another bolus has not been delivered from the syringe to a patient prior to the bolus for which the command was received, or that the syringe pump has been in an idle state, with the syringe being loaded, for a predetermined period of time; and determining the number of bolus sub-cycles and performing the bolus, after determining that the other bolus has not been delivered or that the syringe pump has been in the idle state.
[0097] Clause 17. The method of any one of Clauses 11 to 16, wherein determining characteristic of the syringe comprises: receiving a user input of a syringe type or a syringe size. [0098] Clause 18. The method of Clause 17, wherein the determined number of bolus sub-cycles is proportional to the syringe size such that a first syringe size is determined to have a greater number of bolus sub-cycles than a second syringe size when the first syringe size is larger than the second syringe size.
[0099] Clause 19. The method of any one of Clauses 11 to 18, wherein performing the bolus comprises: performing an initial bolus sub-cycle of the number of bolus sub-cycles for a longer duration or greater volume than subsequent bolus sub-cycles of the number of bolus sub-cycles.
[0100] Clause 20. A non-transitory machine-readable medium storing instructions that, when executed by a machine, cause the machine to perform a method according to any one of the Claims 11 to 19.
[0101] Further Consideration:
[0102] It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of example approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
[0103] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. The previous description provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects. Thus, the claims are not intended to be limited to the aspects shown herein, but is to be accorded the full scope consistent with the language claims, wherein reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention described herein. [0104] The predicate words “configured to”, “operable to”, and “programmed to” do not imply any particular tangible or intangible modification of a subject, but, rather, are intended to be used interchangeably. For example, a processor configured to monitor and control an operation or a component may also mean the processor being programmed to monitor and control the operation or the processor being operable to monitor and control the operation. Likewise, a processor configured to execute code can be construed as a processor programmed to execute code or operable to execute code.
[0105] The term automatic, as used herein, may include performance by a computer or machine without user intervention; for example, by instructions responsive to a predicate action by the computer or machine or other initiation mechanism. The word “example” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “example” is not necessarily to be construed as preferred or advantageous over other aspects or designs.
[0106] A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such as an “embodiment” may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such as a “configuration” may refer to one or more configurations and vice versa.
[0107] As used herein a “user interface” (also referred to as an interactive user interface, a graphical user interface or a UI) may refer to a network based interface including data fields and/or other control elements for receiving input signals or providing electronic information and/or for providing information to the user in response to any received input signals. Control elements may include dials, buttons, icons, selectable areas, or other perceivable indicia presented via the UI that, when interacted with (e.g., clicked, touched, selected, etc.), initiates an exchange of data for the device presenting the UI. A UI may be implemented in whole or in part using technologies such as hyper-text mark-up language (HTML), FLASH™, JAVA™, .NET™, C, C++, web services, or rich site summary (RSS). In some embodiments, a UI may be included in a stand-alone client (for example, thick client, fat client) configured to communicate (e.g., send or receive data) in accordance with one or more of the aspects described. The communication may be to or from a medical device or server in communication therewith.
[0108] As used herein, the terms “determine” or “determining” encompass a wide variety of actions. For example, “determining” may include calculating, computing, processing, deriving, generating, obtaining, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like via a hardware element without user intervention. Also, “determining” may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like via a hardware element without user intervention. “Determining” may include resolving, selecting, choosing, establishing, and the like via a hardware element without user intervention.
[0109] As used herein, the terms “provide” or “providing” encompass a wide variety of actions. For example, “providing” may include storing a value in a location of a storage device for subsequent retrieval, transmitting a value directly to the recipient via at least one wired or wireless communication medium, transmitting or storing a reference to a value, and the like. “Providing” may also include encoding, decoding, encrypting, decrypting, validating, verifying, and the like via a hardware element.
[0110] As used herein, the term “message” encompasses a wide variety of formats for communicating (e.g. , transmitting or receiving) information. A message may include a machine readable aggregation of information such as an XML document, fixed field message, comma separated message, JSON, a custom protocol, or the like. A message may, in some implementations, include a signal utilized to transmit one or more representations of the information. While recited in the singular, it will be understood that a message may be composed, transmitted, stored, received, etc. in multiple parts.
[OHl] As used herein, the term “selectively” or “selective” may encompass a wide variety of actions. For example, a “selective” process may include determining one option from multiple options. A “selective” process may include one or more of: dynamically determined inputs, preconfigured inputs, or user-initiated inputs for making the determination. In some implementations, an n-input switch may be included to provide selective functionality where n is the number of inputs used to make the selection.
[0112] As user herein, the terms “correspond” or “corresponding” encompasses a structural, functional, quantitative and/or qualitative correlation or relationship between two or more objects, data sets, information and/or the like, preferably where the correspondence or relationship may be used to translate one or more of the two or more objects, data sets, information and/or the like so to appear to be the same or equal. Correspondence may be assessed using one or more of a threshold, a value range, fuzzy logic, pattern matching, a machine learning assessment model, or combinations thereof.
[0113] In any embodiment, data generated or detected can be forwarded to a “remote” device or location, where “remote,” means a location or device other than the location or device at which the program is executed. For example, a remote location could be another location (e.g., office, lab, etc.) in the same city, another location in a different city, another location in a different state, another location in a different country, etc. As such, when one item is indicated as being “remote” from another, what is meant is that the two items can be in the same room but separated, or at least in different rooms or different buildings, and can be at least one mile, ten miles, or at least one hundred miles apart. “Communicating” information references transmitting the data representing that information as electrical signals over a suitable communication channel (e.g., a private or public network). “Forwarding” an item refers to any means of getting that item from one location to the next, whether by physically transporting that item or otherwise (where that is possible) and includes, at least in the case of data, physically transporting a medium carrying the data or communicating the data. Examples of communicating media include radio or infra-red transmission channels as well as a network connection to another computer or networked device, and the internet or including email transmissions and information recorded on websites and the like.

Claims

What is claimed is:
1. A syringe pump, comprising: a receptacle for loading a syringe, the syringe comprising a barrel and a plunger; and a controller, the controller configured to: receive a command for the syringe pump to perform a bolus of fluid, the syringe pump configured to deliver the fluid through an infusion line by way of advancing the plunger into a barrel of the syringe when loaded in the receptacle; determine that the syringe should be preconditioned for the bolus; determine a characteristic of the syringe; determine a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic, each bolus sub-cycle comprising advancing the plunger a division of a total distance required to complete the bolus and then stopping before the plunger further advanced to complete the bolus; and perform, responsive to the command, the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe.
2. The syringe pump of Claim 1, wherein the number of bolus sub-cycles is determined before performing the bolus, the controller further configured to: determine the number of bolus sub-cycles of the bolus to perform the bolus based on indexing a table based on the determined characteristic.
3. The syringe pump of Claim 1, wherein the number of bolus sub-cycles is determined while performing the bolus, the controller further configured to: determine, based on the determined characteristic, a force required for at least one sub-cycle; monitor a force of the bolus using a force sensor associated with the syringe pump; and perform each bolus sub-cycle until a threshold force is measured by the force sensor during the at least one sub-cycle.
4. The syringe pump of Claim 3, the controller further configured to: complete the bolus when a force measured for a respective bolus sub-cycle of the number of bolus sub-cycles is less than a force measured for two or more bolus sub-cycles performed prior to the respective bolus sub-cycle.
5. The syringe pump of Claim 3 or Claim 4, wherein receiving the command comprises receiving a command to prime the infusion line, the controller further configured to: determine whether the infusion line comprises a priming cap; determine the threshold force based on whether the infusion line comprises the priming cap; and automatically complete the bolus when the force sensor measures the threshold force.
6. The syringe pump of any one of Claim 1 and 3 to 5, wherein the number of bolus sub-cycles is determined while performing the bolus, the controller further configured to: determine, based on the determined characteristic, a force delta threshold; monitor a force of each bolus sub-cycle that is performed by the syringe pump using a force sensor associated with the syringe pump; and complete the bolus when a variance between a force measured by the force sensor for a first set of consecutive bolus sub-cycles and a force measured by the force sensor for a second subsequent set of consecutive bolus sub-cycles satisfies the force delta threshold.
7. The syringe pump of any one of Claims 1 to 6, the controller further configured to: determine that another bolus has not been delivered from the syringe to a patient prior to the bolus for which the command was received, or that the syringe pump has been in an idle state, with the syringe being loaded, for a predetermined period of time; and determine the number of bolus sub-cycles and performing the bolus, after determining that the other bolus has not been delivered or that the syringe pump has been in the idle state.
8. The syringe pump of any one of Claims 1 to 7, wherein determining characteristic of the syringe comprises: receiving a user input of a syringe type or a syringe size.
9. The syringe pump of Claim 8, wherein the determined number of bolus subcycles is proportional to the syringe size such that a first syringe size is determined to have a greater number of bolus sub-cycles than a second syringe size when the first syringe size is larger than the second syringe size.
10. The syringe pump of any one of Claims 1 to 9, wherein performing the bolus comprises: performing an initial bolus sub-cycle of the number of bolus sub-cycles for a longer duration or greater volume than subsequent bolus sub-cycles of the number of bolus subcycles.
11. A method performed by a syringe pump, comprising: receiving, by a syringe pump, a command for the syringe pump to perform a bolus of fluid, the syringe pump configured to deliver the fluid through an infusion line by way of advancing a plunger into a barrel of a syringe loaded in the syringe pump; determining that the syringe should be preconditioned for the bolus; determining a characteristic of the syringe; determining a number of bolus sub-cycles of the bolus to perform the bolus based on the determined characteristic, each bolus sub-cycle comprising advancing the plunger a division of a total distance required to complete the bolus and then stopping before the plunger further advanced to complete the bolus; and performing, responsive to the command, the bolus while performing the number of bolus sub-cycles during the bolus to precondition the syringe.
12. The method of Claim 11, wherein the number of bolus sub-cycles is determined before performing the bolus, the method further comprising: determining the number of bolus sub-cycles of the bolus to perform the bolus based on indexing a table based on the determined characteristic.
13. The method of Claim 11, wherein the number of bolus sub-cycles is determined while performing the bolus, the method further comprising: determining, based on the determined characteristic, a force required for at least one sub-cycle; monitoring a force of the bolus using a force sensor associated with the syringe pump; and performing each bolus sub-cycle until a threshold force is measured by the force sensor during the at least one sub-cycle.
14. The method of Claim 13, further comprising: completing the bolus when a force measured for a respective bolus sub-cycle of the number of bolus sub-cycles is less than a force measured for two or more bolus sub-cycles performed prior to the respective bolus sub-cycle.
15. The method of any one of Claims 11, 13, and 14, wherein the number of bolus sub-cycles is determined while performing the bolus, the method further comprising: determining, based on the determined characteristic, a force delta threshold; monitoring a force of each bolus sub-cycle that is performed by the syringe pump using a force sensor associated with the syringe pump; and completing the bolus when a variance between a force measured by the force sensor for a first set of consecutive bolus sub-cycles and a force measured by the force sensor for a second subsequent set of consecutive bolus sub-cycles satisfies the force delta threshold.
16. The method of any one of Claims 11 to 15, further comprising: determining that another bolus has not been delivered from the syringe to a patient prior to the bolus for which the command was received, or that the syringe pump has been in an idle state, with the syringe being loaded, for a predetermined period of time; and determining the number of bolus sub-cycles and performing the bolus, after determining that the other bolus has not been delivered or that the syringe pump has been in the idle state.
17. The method of any one of Claims 11 to 16, wherein determining characteristic of the syringe comprises: receiving a user input of a syringe type or a syringe size.
18. The method of Claim 17, wherein the determined number of bolus sub-cycles is proportional to the syringe size such that a first syringe size is determined to have a greater number of bolus sub-cycles than a second syringe size when the first syringe size is larger than the second syringe size.
19. The method of any one of Claims 11 to 18, wherein performing the bolus comprises: performing an initial bolus sub-cycle of the number of bolus sub-cycles for a longer duration or greater volume than subsequent bolus sub-cycles of the number of bolus subcycles.
20. A non-transitory machine-readable medium storing instructions that, when executed by a machine, cause the machine to perform a method according to any one of the method according to any one of Claims 11 to 19.
EP23725499.0A 2023-04-25 2023-04-25 Device, method, and system for automated preconditioning of a syringe during bolus delivery of a fluid Pending EP4701681A1 (en)

Applications Claiming Priority (1)

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PCT/US2023/019855 WO2024226037A1 (en) 2023-04-25 2023-04-25 Device, method, and system for automated preconditioning of a syringe during bolus delivery of a fluid

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EP4701681A1 true EP4701681A1 (en) 2026-03-04

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EP (1) EP4701681A1 (en)
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WO (1) WO2024226037A1 (en)

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4435173A (en) * 1982-03-05 1984-03-06 Delta Medical Industries Variable rate syringe pump for insulin delivery
US8571881B2 (en) * 2004-11-09 2013-10-29 Spectrum Dynamics, Llc Radiopharmaceutical dispensing, administration, and imaging
EP2093685A1 (en) * 2008-02-21 2009-08-26 F.Hoffmann-La Roche Ag Drug administration device having a bolus administration profile controller
EP3797399B1 (en) * 2018-05-23 2025-01-22 ACIST Medical Systems, Inc. Flow measurement using image data

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