Infusion set loading tray
The infusion pump loading tray addresses misalignment and cost issues in existing systems by aligning pumping segments with infusion pumps, ensuring consistent and accurate infusion through reusable alignment, reducing production costs and false alarms.
Patent Information
- Application Number
- PCT/US2024/034835
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2024-06-20
- Publication Date
- 2025-12-26
AI Technical Summary
Existing infusion pumps face issues with hinge-door assemblies leading to misplacement of pumping elements, affecting infusion accuracy, and cassette loading systems increase production costs and user influence on alignment, resulting in inconsistent performance.
A loading tray is used to present the pumping segment to the infusion pump, aligning it with pumping mechanisms and safety features, allowing for precise positioning and reusable operation, decoupling set loading from performance and safety features.
The loading tray reduces production costs, minimizes misalignment issues, and ensures consistent infusion performance by automating precise alignment, reducing false alarms and improving infusion accuracy.
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Figure US2024034835_26122025_PF_FP_ABST
Abstract
Description
INFUSION SET LOADING TRAYTECHNICAL FIELD
[0001] The present disclosure relates generally to intravenous infusion pump mechanisms. In particular, the present disclosure relates to the loading and presentation of an infusion set pumping segment into an infusion pump.BACKGROUND
[0002] In the medical field, infusion pumps are used often to administer accurate amounts of infusates from an external bag to a patient via an intravenous (IV) administration set. The IV administration set is used to administer fluids, medications, or blood products directly into the patient's bloodstream. It typically consists of a plastic or flexible tubing with connectors on either end — one end attaches to a fluid source such as a saline bag or medication vial, while the other end connects to a needle or catheter inserted into a vein. The IV administration set includes a pumping segment — a section of tubing in the IV administration set — that loads into the infusion pump and passes through the pump's rollers or squeeze mechanism. As the pump compresses and releases the tubing of the pumping segment in a rhythmic motion, it generates a pulsatile flow, effectively propelling fluid through the tubing of the IV administration set and into the patient's bloodstream.
[0003] Typical infusion pumps contain a hinge-door assembly which the user must open to load the pumping segment into the bay of the infusion pump. The use of the door to access the pumping segment bay is problematic for a number of reasons. In order to open the door, the user must apply force to the door, as the typical hinge-door assembly utilizes a spring- loaded opening mechanism. Consistent application of force on the door can lead to eventual misplacement of the pumping elements within the infusion pump, leading to pumping inaccuracies over time as the pumping elements become more heavily mispositioned. Furthermore, once the user places the pumping segment into the pumping segment bay, the user must close the door before pumping can begin. Closing the door inconsistently, such as with additional force, can affect the position of the pumping segment itself, causing a potential interference in the infusion performance.
[0004] Other infusion pump systems use a cassette loading system rather than a hinge-door assembly. Cassette loading mechanisms involve the use of a pre-assembled cassette containingthe pumping segment and other components, which is loaded into a dedicated compartment of the pump. While cassette loading may provide a higher level of automation, there an additional cost and burden of building the cassette on each individual disposable administration set, which must be disposed of after each infusion to a patient. The cassette itself is typically a plastic piece built to interface and load the pumping segment into the infusion pump, and typically contains a plastic rigid element for the pumping fingers to pump against. These pieces further add to production costs. Some cassettes may even contain certain performance features that are traditionally built into the pump, such as the rigid element, the air-in-line (AIL) sensor and / or pressure sensor, which may further increase costs of the set. Furthermore, manual loading of a cassette into a pump allows for user influence on the alignment of these critical performance features.SUMMARY
[0005] The present disclosure addresses the aforenoted problems by utilizing a loading tray to present the pumping segment to the infusion pump rather than a traditional hinge-door assembly or cassette loading system. In some implementations, the loading tray couples to the pumping segment and, when loaded into the pump with the pumping segment, aligns the pumping segment with the pumping mechanism and any performance features. In some implementations, the loading tray is integrated with a pumping segment. In some implementations, the loading tray may be built into the infusion pump itself and is reusable without having to dispose of the tray after each infusion.
[0006] According to various implementations, the loading tray allows the pumping segment to be consistently presented between the pumping fingers, pumping occluders, and the rigid element to ensure sufficient and stable compression. The loading tray (e.g., with the pumping segment therein) may be pushed into the infusion pump by the user and thereafter locked into precise position by the infusion pump. Alternatively, after the tray is pushed into the infusion pump by the user, the infusion pump may adjust the pumping elements themselves to align themselves in relation to the pumping segment in the loading tray (e.g., based on an identification of alignment markers on the loading tray). After infusion, the loading tray may be ejected from the pump, and the loading tray and / or administration set disposed of.
[0007] The use of a loading tray to load the infusion pump with the pumping segment provides many benefits over the existing hinge-door assembly and cassette loading systems.The loading tray greatly reduces production costs over the cassette loading system as the loading tray can be reusable, rather than having to be disposed of like a cassette on an administration set. Instead, after infusion, the user may simply eject the loading tray, remove and dispose of the administration set, and load a new administration set into the loading tray to begin another infusion. This removes the requirement of having to build in a cassette loader into each individual administration set.
[0008] Additionally, the use of the loading tray reduces the likelihood of pumping elements shifting out of place over time, as the infusion pump itself may precisely shift the pumping elements and safety systems into place in relation to the pumping segment rather than the user doing so manually. The loading tray system allows decoupling of the loading of the set from the performance and safety features of the infusion pump. Because the tray is used solely to present and align the pumping segment to the infusion pump, and because the pumping elements and safety features are all located within the pump itself, the performance features of the pump will not be influenced by inconsistent user loading and aligning the pumping segment into the pump. The presentation of the pumping segment to the pump using the loading tray of the subject technology is understood as being more consistent and uninfluenced by the user than traditional methods, and the performance and safety features may operate more optimally due to the alignment of the pumping segment by the tray.
[0009] According to various implementations, an apparatus for loading a pumping segment of an infusion set into an infusion pump, comprises a rigid surface comprising one or more supports configured to align and constrain the pumping segment in a fixed linear position; and one or more alignment features configured to, when the apparatus is inserted within the infusion pump, align the constrained pumping segment with respect to a pumping mechanism of the infusion pump and the rigid surface, wherein the apparatus is configured to be inserted into and removed from the infusion pump and to engage the constrained pumping segment with the pumping mechanism when inserted and to disengage the constrained pumping segment from the pumping mechanism when removed. Other aspects include corresponding systems and methods for implementation of the corresponding apparatus and its features.
[0010] 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 differentconfigurations 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
[0011] For a better understanding of the various described implementations, reference should be made to the Description of Implementations below, in conjunction with the following drawings. Like reference numerals refer to corresponding parts throughout the figures and description.
[0012] FIG. 1A depicts a perspective view of an example infusion pump showing an infusion set in place within the infusion pump, according to various aspects of the subject technology.
[0013] FIG. IB depicts an example patient care unit shown, according to various aspects of the subject technology.
[0014] FIG. 2 depicts an example pumping mechanism of an infusion pump, according to various aspects of the subject technology.
[0015] FIG. 3 depicts an example cam phase diagram corresponding to a fluid delivery cycle of an infusion pump, according to various aspects of the subject technology.
[0016] FIG. 4 depicts a cutaway view of the internal components of a large volume pump, according to aspects of the subject technology.
[0017] FIG. 5 depicts a top view of an example loading tray for an infusion set, according to various aspects of the subject technology.
[0018] FIGS. 6A to 6F depict various views of an example loading tray drawer for assisted loading of the tray and pumping segment into an infusion pump, according to aspects of the subject technology.
[0019] FIG. 6G depicts another example loading tray drawer for assisted loading of the tray and pumping segment into an infusion pump, according to aspects of the subject technology.
[0020] FIG. 7 depicts an example process for utilizing an infusion set loading tray, according to aspects of the subject technology.
[0021] FIG. 8 is another example infusion pump, according to various aspects of the subject technology.
[0022] FIG. 9 is a conceptual diagram illustrating an example electronic system for operating an infusion pump with an infusion set loading tray, according to aspects of the subject technology.DESCRIPTION
[0023] 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.
[0024] As will be described further, the subject technology includes a loading tray for loading and unloading a pumping segment of an infusion set to and from an infusion pump is disclosed. The tray includes a rigid planar surface that includes one or more supports for aligning and constraining the pumping segment in a fixed linear position, and one or more alignment features configured to, when the tray is inserted within the pump, align the rigid planar surface and the constrained pumping segment with respect to a pumping mechanism. The tray is configured to be inserted into and removed from the pump and to engage the pumping segment with the pumping mechanism when inserted, and to disengage the constrained pumping segment from the pumping mechanism when removed. In some implementations, the loading tray may be inserted into, or can be part of a drawer of, the pump for quick insertion of the pumping segment into the pump or removal therefrom.
[0025] For infusion pump applications, the proper placing of an infusion tubing within the pump casing is a critical step. When the infusion tubing is not placed properly, the air-in-line sensor may tend to sound an alarm for improper positioning. Additionally, pressure sensors within the device may provide erroneous pressure readings, causing further alarms or otherunintended results. In this regard, existing systems may generate multiple false alarms when the infusion tubing is not properly placed within the pump with respect to these performance features. Accordingly, health care personnel may have to repeatedly accommodate the infusion tubing to guarantee a proper medication infusion procedure. This causes inefficiencies and may create serious health care outcomes when a medical emergency demands quick and reliable operation.
[0026] For example, a false alarm may be caused by an improper installation of the IV set, because a user forgets to hand-thread the IV line in the air-in-line slot so that the alarm goes off as soon as the user closes the door / latch due to improper placement of the infusion tubing within the air-in-line housing. False alarms may occur after infusion starts, when the infusion tubing is near the edge of the air-in-line sensor range, e.g., too far inside, or not far enough within the slot in the air-in-line sensor. Accordingly, the infusion tubing may be displaced out of the sensing area after infusion starts due to mechanical adjustment, thus trigger a false alarm.
[0027] The subject technology disclosed herein largely mitigates the above problem by automating the precise location of the infusion tubing with respect to performance features of an infusion pump to avoid a false alarm activation and other unintended consequences. Additionally, implementations of the present disclosure include features for applying a constant strain relief to the infusion tubing by having the tubing that is subject to the pumping mechanism of the pump be in a fixed linear position at all times. Such configuration has the added benefit of facilitating the positioning of the pump, and the handling of the infusion tubing without the risk of inducing kinks or tears in the tubing.
[0028] Some of the advantages of embodiments consistent with the present disclosure include a secure and reliable mechanism for placing infusion tubing in place for IV medication delivery, and simplifying the handling of infusion setups including infusion tubing and pumps in the vicinity of a patient.
[0029] FIG. 1A depicts a perspective view of an example infusion pump showing an infusion set in place within the infusion pump, according to various aspects of the subject technology. An infusion system for parenteral infusion of a medical fluid to a patient comprises a pump unit 10, a major part of which comprises a housing or casing 22 which accommodates, in manner known per se, a cam system (not shown) controlling a plurality of fingers of a pumping mechanism, an electric motor and associated gearing, driving said cam mechanism,and further accommodates electronic control and processing circuitry for controlling such motor and processing signals from pressure sensors etc. provided on the unit. The pump unit, as shown, may also comprise an electronically operated display, an alarm light, an input keyboard or other manually operated controls, all in manner known per se.
[0030] As shown in FIG. 1A, the infusion pump 10 (aka an “infusion device”) is shown in perspective view with the front door 50 open, showing the upstream fluid line 30 (e.g., portion between fluid container and the infusion pump 30) and downstream fluid line 31 (e.g., portion between the infusion pump 31 and a patient) in operative engagement with the infusion pump 10. An infusion set tubing may include a continuous fluid conduit formed from the upstream fluid line 30 to the downstream fluid line 31, extending from a respective fluid supply to a patient, through which fluid is acted upon by the pump to move fluid downstream to the patient. The infusion pump 10 directly acts on a pumping segment 66 of the infusion set that passes through the pumping mechanism 70 of the pump. Specifically, the pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit. The depicted references 30, 31, 66 may be used to describe herein portions of one continuous fluid line or, in some implementations, may individually describe portions that are fluidly connected together to form a continuous fluid line. The upstream and downstream fluid lines and / or tube 30, 31, 66 may also be coupled to a pump cassette or cartridge that is configured to be coupled to the pump 10.
[0031] As shown in FIG. 1 A, the face plate 50 which may be opened to reveal the internal loading mechanism for an infusion set. Within the housing of the infusion pump (e.g., behind the door or face place), the infusion pump includes a pumping mechanism including a group of serially-aligned pumping elements configured to compress an elongated compressible channel of the pumping segment 66, when loaded within the pumping mechanism of the pump. The pumping mechanism includes a group of serially-aligned pumping elements (e.g., occluders and / or pumping finger(s)) configured to compress the elongated compressible channel (e.g., an IV tubing segment) loaded within the pumping mechanism.
[0032] The infusion set includes an intermediate section of the resiliently compressible tubing 66, for example of silicone rubber and, in some implementations, upper and / or lower fittings which each tubing section may be connected respectively with a respective upper line 30 and with the lower line 31. In use, each upper line 30 extends upwardly to a source of the medical fluid to be administered whilst the lower line 31 extends from the infusion pump to aninfusion needle or the like inserted into the patient. In use, the infusion set 66 is extended across the face or deck of the pump unit so that its fittings (not labeled) are received in respective brackets respectively and so that the tubing segment extends over a pumping mechanism. In the depicted example, the pumping mechanism includes a four finger pump assembly 72, 74, 76, 78. In the depicted example, the infusion set is fitted in place in this fashion whilst the door 50 is in the open position. After the infusion line has been so fitted, the door 50 may be moved to the closed position and is secured by a catch 52 which may include a lever mounted on the outer edge of the door.
[0033] The four finger pump assembly 72, 74, 76, 78 includes respective fingers that are moveable by a cam system inwards and outwards from the face or deck of the pump to compress a respective tubing segment against a counter surface or anvil to propel fluid within the infusion line. In order to make it easier to maintain sterile conditions, these fingers may be covered by a thin flexible membrane, (not shown), sealed at its edges with respect to the deck. The fingers of the pump assembly periodically press the flexible resilient tubing against the counter surface which may be configured on an opposite side, for example, on an inner portion of the door 50.
[0034] The type of pumping mechanism may vary, including the number of fingers in the pumping mechanism. In the depicted example, the pumping mechanism includes an upstream occluding element or finger 72, a primary pumping element or finger 74, a downstream occluding element or finger 76, and a secondary pumping element or finger 78. The pumping mechanism (and mechanisms used in other linear peristaltic pumps) operate by sequentially pressing on a segment of the fluid conduit by means of the cam-following pumping elements (e.g., pumping fingers and valve fingers) 72, 74, 76, and 78, which in the depicted example make a four finger pump assembly. Each element may be sequentially activated by a respective cam lobe on a camshaft to apply a downward compression against tubing 66, to move the fluid in the tubing 66 downstream. Intermediate pumping mechanism 74 may include multiple intermediate elements or fingers (not shown) that sequentially activate according to positioning of the cam lobes. In some implementations, the pressure is applied in sequential locations of the conduit, beginning at the upstream end of the pumping mechanism, and working toward the downstream end. At least one finger is always pressing hard enough to occlude the conduit. As a practical matter, one finger does not retract from occluding the tubing until the next one in sequence has already occluded the tubing; thus, at no time is there a direct fluid path fromthe fluid supply to the patient. The operation of peristaltic pumps including four finger pumps is well known to those skilled in the art and no further operational details are provided here.
[0035] An upstream pressure sensor 80 may also be included in the pump 10. The upstream pressure sensor may be mounted to pumping mechanism 70 or located adjacent and upstream in relation to the pumping mechanism 70 between a fluid supply and the pumping mechanism 70, so that the connection of the correct fluid supply with the correct pump may be verified before any fluid is pumped to the patient. A downstream pressure sensor 82 is also included in the example infusion pump 10 at a downstream location with respect to the pumping mechanism, that is, at a location between the patient and the flow control device, so that the connection of the correct fluid supply with the correct pump may be verified before any fluid is pumped to the patient. Downstream pressure sensor 82 may be used to detect a pressure change adjacent to occluder 76 and / or downstream finger 78, to determine whether these elements are functioning properly.
[0036] The pump 10 also includes an air-in-line (AIL) sensor 84. In some implementations, air-in-line sensor 84 may be mounted at a bottom end of chassis 22. air-in-line sensor 84 may include two sensing elements disposed on opposite sides of a slot through which the infusion tubing 66 passes. The air-in-line sensor 84 includes a signal (e.g., an ultrasound signal) traveling across the tubing that includes the infusion fluid). Accordingly, infusion tubing 66 should be seated appropriately so that the ultrasound signal in air-in-line sensor 84 traverses the fluid.
[0037] In some implementations, the infusion set 66 may include a cartridge 86 that clips into a compartment 88 of the pump for proper positioning. In the depicted example, the cartridge 86 includes a flow stop that is received into a corresponding compartment 88 in the casing 22 above the air-in-line sensor 84. In this regard, the flow stop cartridge plugs into the compartment and facilitates alignment of the fluid line 66 with the pumping components, and further facilitates alignment of the downstream line 31 with the air-in-line sensor 84.
[0038] FIG. IB depicts an example patient care unit 12 shown, according to various aspects of the subject technology. FIG. IB shows two functional infusion pumps 10 (e.g., “infusion pump modules”) mounted at either side of a main frame infusion controller 14, and the displays and control keys of each, with the main frame infusion controller 14 being capable of programming both infusion pumps. The infusion pump includes a door 5a and a handle 5b thatoperates to lock the door in a closed position for operation and to unlock and open the door for access to the internal pumping and sensing mechanisms and to load administration sets for the pump. When the door 5a is open, the tube can be connected with the pump 10. When the door 5a is closed, the tube is brought into operating engagement with the pumping mechanism, the upstream and downstream pressure sensors, and the other equipment of the pump. A display 5c, such as an LED display, is located in plain view on the door in this embodiment and may be used to visually communicate various information relevant to the pump 10, such as alert indications (e.g., alarm messages). Control keys 5e-h may exist for programming and controlling operations of the infusion pump as desired. In some implementations, the control keys may be presented as interactive elements on the display 5c (e.g., touchscreen display). The main frame and / or functional module may also include audio alert equipment in the form of a speaker (not shown).
[0039] The main frame infusion controller 14 of the patient care unit 12 includes a display 6a for visually communicating various information, such as the operating parameters of a connected pump and alert indications and alert messages, and control keys 6b and 6c for selecting and / or setting control parameters and / or options for controlling the patient care unit 12 and connected modules. The main frame infusion controller 14 may also include a speaker to provide audible alerts. In some implementations, the display 6a may be implemented as a touchscreen display. In such implementations, the control keys 6b may be omitted or reduced in number by providing corresponding interactive elements via a graphical user interface presented via the display 6a. In some implementations, each control key 6b (or 6c) may select a corresponding option displayed in display 6b.
[0040] The main frame infusion controller 14 may include a communications system (not shown) with which the main frame infusion controller 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 functional module 10. The communication module may be used to transfer access and interaction information for clinicians encountering the main frame infusion controller or device coupled therewith (e.g., pump 10 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 andcommunications system may alternatively be included integrally with the infusion pump 10, such as in cases where a main frame infusion controller is not used, or in addition to one with the main frame infusion controller 14. Further, information input devices need not be hardwired 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 main frame infusion controller such as a syringe pump module, patient controlled analgesic module, end tidal CO2 monitoring module, oximeter monitoring module, or the like.
[0041] FIG. 2 depicts an example pumping mechanism 120 of an infusion pump 10, according to various aspects of the subject technology. A typical medical pump for IV infusion delivery has two occluders, a first occluder 100 located upstream and a second occluder 110 located downstream, with a plunger 120 (e.g., pumping element 74) in between. The occluders and plunger coordinate with each other in programmable, sequential steps, controlled by a cam shaft to have two phases: 1) a filling phase, and 2) a delivery phase. The occluders move fluid in a tubing 103 by sequentially compressing the tubing, thereby causing a flow in a direction 104 according to the particular compression sequence of the occluders.
[0042] During the medication infusion process, in the filling phase, the upstream occluder 100 lifts to suck the medication into the tubing segment, which creates a pause, followed by the delivery phase to push the fluid out. These sequences can repeat through multiple cycles. To specify, when the plunger of a single plunger / tubing design is lifted from the tubing segment during the filling phase, there will be a disruption in the continuous infusion process.
[0043] FIG. 3 depicts an example cam phase diagram corresponding to a fluid delivery cycle of an infusion pump, according to various aspects of the subject technology. Each row depicted in FIG. 5 corresponds to a pumping element 72, 74, 76, 78, and illustrates an example pumping function of the element according to a complete cam rotation (360°). That is which pumping elements are closing (compressing the tube) and which elements are opening, thereby creating an aspiration phase and a dispensing phase.
[0044] In the depicted example, initially, from 0° to 90°, the upper occluder 72 is open, while the lower occluder remains closed. The upper occluder 72 completes closing at about 120°; however, the fluid tubing may be sufficiently compressed to stop aspiration of the fluid at about 110°. The lower occluder remains closed until the cam reaches 140°. While the upper occluder 72 is open — until it begins to close at about 90° — the upper finger 74 is aspirating.The upper occluder closes between 90-120°, and the lower occluder begins to open at 140°. At this point, the lower finger will begin to deliver the fluid. In the depicted example, delivery begins at about 145°, with about 5° rotation accounting for the time to decompress the tubing.
[0045] FIG. 4 depicts a cutaway view of the internal components of a large volume pump, according to aspects of the subject technology. The internal components of the pump are observable along the infusion tubing path 120 within a housing 122. A door 124 that confines the infusion line in position for action upon the infusion line by the internal components.
[0046] The motor block 126, situated opposite the door 124 within the housing, accommodates a camshaft 128 that orchestrates the synchronized movement of occluders 72, 76 and pumping fingers 74, 78, which make up at least a portion of the pumping mechanism of the infusion pump. This mechanism facilitates peristaltic motion, ensuring precise fluid propulsion through the tubing. Positioned on the camshaft within the motor block, the occluders 72, 76 and pumping fingers 74, 78 work in tandem to create peristaltic motion. The occluders 72, 76, strategically placed along the tubing path 120, prevent backflow and maintain unidirectional fluid flow, while the pumping fingers 74, 78 compress and release tubing to propel the fluid through the system. In some implementations, the occluders and / or pumping fingers may be fluidically isolated from the infusion set 66 by way of a flexible membrane 121.
[0047] According to various implementations, the occluders 72, 76 and the pumping fingers 74, 78 press against an infusion line, with the door 124 and / or a rigid element 134 mounted on the door providing a stable foundation for proper compression of the fluid tubing. In the depicted example, the rigid element includes a platen is part of the door assembly and provides counter-support for the occluders 72, 76, while a portion 136 of the door (hard surface) provides counter-support for the pumping fingers 74, 78. A door latch secures the door (and these rigid elements) during operation and prevents unauthorized access to the internal components.
[0048] Safety features include an air-in-line sensor 84 a / b positioned along the tubing path to detect air bubbles in the infusion line 66. In the event of detection, the sensor triggers alarms, preventing potential complications and ensuring uncontaminated fluid delivery. A pressure sensor(s) 80 and / or 82 monitors tubing pressure, providing real-time feedback for instantaneous adjustments, ensuring accurate and consistent fluid delivery tailored to patient needs.
[0049] While the infusion line may be constrained vertically by a force of the door 124 against it, the infusion line may be subject to lateral movement. After extended operation the infusion line may shift and become misaligned with respect to the occluders 72, 76 and / or pumping fingers 74, 78, subjecting the line to decreased or uneven compression forces which, in turn, cause unexpected fluid flow deviations and / or erroneous readings from the air-in-line and / or pressure sensors.
[0050] Incorporating the rigid element into the pump as a platen 134 within a hinged door assembly can result in inaccuracy of the fluid being delivered due to the angle at which the platen supports the segment and the varying distance of the platen inherent with the positioning of the door assembly and how it is locked in place (e.g., by latch 136). Moreover, the platen 134 may rest on a spring 138, further exaggerating the angle.
[0051] As will be described further, the subject technology places inside the pump a simple infusion set loading tray that decouples the positioning and removal of the infusion set 66 (FIG. 1) from the operation of the pumping mechanics of the infusion pump 10 (e.g., the occluders, fingers, and air-in-line and / or pressure sensor(s)). The infusion set 66 is constrained by the loading tray and, with reference to FIG. 4, the infusion set loading tray is inserted in a fixed position within the pumping gap between the chassis and the door structures. The loading tray may then be removed after an infusion, thereby removing the constrained infusion set.
[0052] The decoupling of the loading and unloading of the infusion set 66 from the operation of the pumping mechanism has several advantages. For example, because the platen typically rests atop a spring to provide the necessary force against the opposing occluder(s) and / or fingers, the platen may be subject to shifting and / or angling upon the spring when the infusion set is not properly aligned. The tray of the subject technology aligns the infusion set 66 to prevent angling of the platen so that the plant may consistently present the infusion line to the pumping fingers. The try further provides more precise control of the gap between the pumping fingers / occluders and the platen resulting in better rate accuracy, and allows for less compression force applied to the pumping segment, as a result of force necessary to pop open the door upon release of the door’s latch. Reduced compression force will prevent damage to the tubing that could result in gross under infusion to the patient.
[0053] FIG. 5 depicts a top view of an example loading tray 200 for an infusion set, according to various aspects of the subject technology.
[0054] The depicted loading tray is disclosed herein for loading a pumping segment of an infusion set into an infusion pump 10, injecting the pumping segment 66 directly into the infusion tubing path 120 (see FIG. 4). According to various aspects, the loading tray 200 includes a rigid planar surface 202 that includes (or is made up of) one or more supports 204 configured to align and constrain a pumping segment 66 in a fixed linear position with respect to the tray 200. In some implementations, one or more supports 204 may include clips into which the infusion line 66 may snap into such that it maintains a stretched orientation across the tray 200. In some implementations, the one or more supports 204 is implemented as a linear slot that, for example, may traverse the tray and constrain the pumping segment 66 within the slot.
[0055] The tray 200 further includes one or more alignment features 206 configured to, when the apparatus is inserted within the infusion pump, align the rigid planar surface 202 and the constrained pumping segment 66 with respect to a pumping mechanism of the infusion pump. In this regard, the tray 200 is configured to be inserted into and removed from the infusion pump and to engage the constrained pumping segment with the pumping mechanism when inserted and to disengage the constrained pumping segment from the pumping mechanism when removed.
[0056] In some implementations, the alignment features 206 includes a flange circumscribing the rigid planar surface. The flange may, for example, be a thin frame (e.g., plastic or metal) encompassing the components of the tray (e.g., supports, rigid areas, etc.), and thereby defining the tray. In some implementations, the alignment features (e.g., a flange may snap into a groove, clips, or other fastener type system within the pump for securing / confining and aligning the constrained pumping segment 66 thereon with the internal pumping components.
[0057] In some implementations, the rigid planar surface may include an area equal to the area defined by the frame 206 (e.g., a surface taking up the entire area within the frame). In some implementations, the rigid planar surface may only include surface areas corresponding to supports 204. In some implementations, the rigid planar surface 202 includes a tubing support surface 208. In such implementations, the one or more supports 204 may be configured to align and constrain the pumping segment 66 in the fixed linear position against the tubing support surface 208 such that a compression force that is applied upon the pumping segmentby the pumping mechanism from a side of the pumping segment opposite the tubing support surface 208 compresses the pumping segment against the tubing support surface 208.
[0058] In some implementations, the tray 200 includes one or more first recesses 210 in a topmost surface of the tray, which are each configured to accommodate one or more of (1) a first air-in-line sensing component of the infusion pump, (2) the pumping mechanism, and (3) a first pressure sensing component of the infusion pump (e.g., a pressure sensor 80, 82 or a receiver or transmitter of the pressure sensor when both are present) when the apparatus is inserted within the infusion pump. In a similar manner, the tray 200 may include one or more second recesses 210 in a bottom surface of the tray, which are each configured to accommodate one or more of a corresponding second air-in-line sensing component of the infusion pump and a corresponding second pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump.
[0059] According to various implementations, the one or more supports 204 and / or the one or more alignment features 206 are further configured to align the constrained pumping segment with at least one of an air-in-line sensing component (e.g., receiver or transmitter 84a or 84b) of the infusion pump 10 and a pressure sensing component (e.g., a pressure sensor 80, 82) of the infusion pump 10 when the apparatus is inserted within the infusion pump 10.
[0060] In such implementations, the rigid planar surface 202 may include respective cutouts 210 in respective regions under the constrained pumping segment that correspond to one or more of the air-in-line sensing component of the infusion pump, the pumping mechanism of the infusion pump, and the pressure sensing component of the infusion pump.
[0061] In some implementations, the tray 200 may include (e.g., instead of a cutout 210), a disposable air-in-line sensing component (e.g., 84a or 84b) that is in a predetermined fixed position (e.g., 210) with respect to the constrained pumping segment such that, when the apparatus is inserted into the infusion pump, the disposable air-in-line sensing component is aligned with and communicates with a corresponding non-disposable air-in-line sensing component of the infusion pump to cause detection of air within a portion of the pumping segment when the air is present. Similarly, the tray 200 may include (e.g., instead of a cutout 210), a disposable pressure sensing component (e.g., a transmitter or receiver of each pressure sensor 80, 82) that is in a predetermined fixed position with respect to the constrained pumping segment such that, when the apparatus is inserted into the infusion pump, the disposablepressure sensing component is aligned with and communicates with a corresponding nondisposable pressure sensing component of the infusion pump to cause detection of a fluid pressure within the pumping segment.
[0062] By way of using the tray 200 of the subject technology, accuracy by the pumping mechanism, fluid pressure accuracy and air-in-line accuracy are improved due to consistent presentation of the pump segment 66 to the elements acting on or sensing off of the infusion set tubing. Consistent presentation means the pump segment is directly between the pump fingers and the platen, the air-in-line transmitter and receiver, and the pressure sensor and the tubing support surface. It also means that these surfaces are parallel to each other and the distances between these pump elements have little variation.
[0063] In other systems, segment over compression resulting from additional force applied to spring the door open upon release of the latch can damage the tubing and result in gross under-infusion. By way of the tray 200 decoupling the pumping and sensing elements from the set loading features and removal mechanism, better rate, pressure and air-in-line accuracy can be achieved. The disclosed tray design eliminates the variability of the door angle and the positioning of the door on these sub-systems.
[0064] FIGS. 6A to 6E depict various views of an example loading tray drawer for assisted loading of the tray and pumping segment into an infusion pump, according to aspects of the subject technology. In the depicted examples, the loading tray 200 is included or forms at least part of a drawer that may be removed from the infusion pump. While depicted as a single unit, the loading tray drawer may include a drawer and the previously described loading tray, which may be loaded into the drawer when the drawer is in an open and extended position. In this regard, the alignment features 206 of the loading tray 200 may couple to corresponding alignment features in the drawer, so that the loading tray may become aligned as previously described with respect to the pumping mechanism 205 and / or sensor(s). Accordingly, the terms “loading tray” and “loading tray drawer” may be used interchangeably when referring to FIGS. 6 A to 6E.
[0065] In the depicted examples, the loading tray drawer 200 is built into the infusion pump 10 and, in some implementations, includes a sliding track 202 that provides movement of the tray 200 into and out of the infusion pump 10 for quick engagement and disengagement of the pumping segment with the pumping mechanism 205 of the infusion pump 10. The sliding trackmay include, for example, a ridge and recess configuration, wherein the tray incorporates a linear ridge along a side of the tray which slides within a groove in the pump casing 22. In some implementations, the sliding track 202 may be below the tray 200. In this regard, as depicted in FIG. 6A, the tray 200 or the sliding track may interact with a spring 206 and a latch 208, 210 to allow for the apparatus to be ejected from the infusion pump when the latch 208 is released and then pushed back into a locked position in the infusion pump and locked in the locked position by the latch.
[0066] According to some various implementations, the latch may include a locking feature 218 located on a bottom surface of the tray 200, which is configured to lock into a corresponding recess 220 (visible in FIG. 6D) within the infusion pump to lock the tray 200 into the locked position and to align the constrained pumping segment 66 with the pumping mechanism 205 (and, in some implementations, an air-in-line sensor and / or a pressure sensor) when the apparatus is inserted within the infusion pump. In this regard, the locking feature 218 may be configured such that, to remove the tray 200 from the infusion pump, the tray is lifted out of the locking position, as depicted by the arrows 212 in FIG. 6 A. In some implementations, the latch may include a button that either lifts the drawer enough for the latch to be released (e.g., by disengaging the locking feature 218 from the recess 220), or that retracts the locking feature 218 into the bottom of the drawer, thereby releasing the drawer. It should be understood that the locking feature 218 and recess 220 may be positioned anywhere with respect to the drawer; e.g., on a side of the drawer or top of the drawer. For example, the locking feature 218 may be positioned on the top of the drawer (and the actuator 214), when moved away as depicted in FIG 6B, moves the recess 220 away thereby causing the drawer to be released.
[0067] As depicted in FIG. 6B, the infusion pump 10 may include an actuator 214 configured to, when the apparatus is being disengaged from the infusion pump, move at least the pumping mechanism or one sensor component away from the loading tray 200 and the pumping segment 66 and, when the apparatus is being inserted into the infusion pump, move the pumping mechanism and / or sensor component(s) toward the loading tray 200 and the pumping segment 66 to engage the pumping segment 66.
[0068] According to various implementations, the actuator 214 may drop a mounting plate for the air-in-line transmitter 84a, pumping finger 205, and pressure sensor 216a into place with the insertion of the tray 200 and raise the mounting plate for unloading of the tray 200 andremoval of the pumping segment 66, instead of recesses in the uppermost surface of the of the inner surface of the back tray. In some implementations, an alternative to the recesses in the bottom of the innermost tray surface may include a mounting plate for the air-in-line receiver 84b, platen 134 and tubing support surface for the pressure sensor could be raised and lowered in the same way.
[0069] FIG. 6C depicts another cutaway view of the example loading tray drawer 200 in which the air-in-line components 84a and 84b are visible. In the depicted example, one air-in- line component 84a is part of the pump 10, and another air-in-line component 84b is part of the tray 200. In such implementations, particularly wherein the tray component 200 is removable from the drawer component, the air-in-line component 84b may be disposable, while the air- in-line component 84a that is part of the pump may not be disposable. In some implementations, the tray component 84b may a transmitter while the sensor component 84a is the receiver, while in other implementations the components may be reversed.
[0070] FIG. 6D depicts the same cutaway view as 6C but with the loading tray drawer 200 moved out of the infusion tubing path 120 wherein the pumping segment is disengaged from the pumping mechanism and sensor(s). As shown, when the locking feature 208 is disengaged from the recess 210, the spring 206 pushes the loading tray 200 (via the track 202) out of the infusion pump 10 so that the pumping segment 66 is accessible to the user. In some implementations, wherein the drawer and tray are separate pieces, the loading tray 200 (as depicted in FIG. 4) can be removed from the loading tray drawer. In this manner, the loading tray is disposable while the drawer remains part of the infusion pump. In some implementations, the sensor component(s) (e.g., 84b) may remain in the drawer as part of the pump when the loading tray 200 is lifted out of the drawer, leaving the sensor(s) ready to receive a new tray.
[0071] FIGS. 6E and 6F depict a cutaway view of the portion of the tray that includes pressure sensing components (e.g., a transmitter(s) and receiver(s) of pressure sensor(s) 80 and / or 82). The operation of the tray 200 as it relates to the actuator is the same as in FIGS. 6A and 6B. As in FIG. 6C, one pressure sensing component 216a is part of the pump 10, and another pressure sensing component 216b is part of the tray 200. In such implementations, particularly wherein the tray component 200 is removable from the drawer component, the pressure sensing component 216b may be disposable, while the pressure sensing component 216a that is part of the pump may not be disposable. In some implementations, the pressuresensing component 216b may a transmitter while the pressure sensing component 216a is the receiver, while in other implementations the components may be reversed.
[0072] FIG. 6G depicts another example loading tray drawer for assisted loading of the tray and pumping segment into an infusion pump, according to aspects of the subject technology. In the depicted example, the tray 200 is configured as a drawer that can swing 228 in and out of the pump 10. As previously described with regard to FIG. 5, the tray may include one or more supports configured to align and constrain a pumping segment 66 in a fixed linear position with respect to the tray 200. In the depicted example, the one or more supports are implemented as a linear slot 204 that traverses the tray and constrain the pumping segment 66 within the slot.
[0073] As depicted, the pump 10 (e.g., the pump’s housing) may include a lower portion 230 and an upper portion 232, with the tray 200 pivotably attached to a pivot 234 so that it can swing out from between the lower and upper portions. The tray is pivoted outward 228, pivoting about pivot 206, for loading of the infusion set 66. Once loaded, the tray may be pivoted inward between the lower and upper portions, and latched into place. One of the lower or upper portions may include the pumping mechanism 205 (and in some implementations, actuator 214), while the other portion may include a rigid planar surface against which the infusion administration set 66 is compressed, when inserted into the tray and the tray positioned between the upper and lower portions, as depicted in FIG. 6G.
[0074] FIG. 7 depicts an example process 300 for utilizing an infusion set loading tray, according to aspects of the subject technology. For explanatory purposes, the various blocks of example process 300 are described herein with reference to FIGS. 1 through 6, and the components and / or processes described herein. The one or more of the blocks of process 300 may be implemented, for example, by the infusion pump 10 described herein. In some implementations, one or more of the blocks may be implemented based on electromechanical and / or computer control. For explanatory purposes, the blocks of example process 300 are described as occurring in serial, or linearly. However, the blocks of example process 300 may occur in parallel. In addition, the blocks of example process 300 need not be performed in the order shown and / or one or more of the blocks of example process 300 need not be performed.
[0075] In the depicted example, a loading tray 200 is provided that constrains a pumping segment 66 of an infusion set in a fixed linear position (302). The loading tray 200 may includeone or more supports (or fasteners) for constraining the pumping segment 66 (e.g., in a stretched position). The tray further includes at least alignment feature for aligning the tray in the proper position within the pump - such as to align the pumping segment 66 with the functional components of the pump.
[0076] In some implementations, the tray 200 may include cutouts in each region where the air-inline sensor 84, pumping mechanism 205, and pressure sensor elements act on the pumping segment 66. As depicted in FIG. 6, the tray 200 may incorporate an inner surface parallel to the front case of the instrument that is of sufficient height to allow a spring(s) 206 to push the tray out of the pump when the latch is released.
[0077] The loading tray drawer 200 may incorporate a locking feature 208 that drops / snaps into place 210 when the loading tray drawer 200 is pushed into position. In some implementations, the loading tray drawer 200 may be lifted out of a locking position in order for the springs 206 to push the tray out. As described previously, tracks inside the pump will guide the operation of the tray.
[0078] The tray is inserted into the infusion pump 10 to engage the constrained pumping segment 66 with the functional components of the pump (304). As described previously with regard to FIGS. 6 A - 6F, the pump may include a loading tray drawer into which the loading tray may be placed. In some implementations, the loading tray itself is the drawer, and may be loaded onto one or more tracks within the pump (to complete operation as a drawer). Opening and closing of the drawer may be accomplished with a latch or by electromechanical and / or computer control.
[0079] In some implementations, recesses in the topmost surface of the inner tray surface may accommodate one or more of the air-in-line transmitter, pumping mechanism, and pressure sensor elements during loading and ejection of the tray 200. Similarly, recesses in the bottom most surface of the inner tray surface may also accommodate one or more of the air-in- line receiver, the pumping platen, and a tubing support surface for the pressure sensor support.
[0080] When the infusion is completed, the tray 200 is removed from the infusion pump to disengage the constrained pumping segment 66 from the functional components of the pump 10 (306). The tray and / or the pumping segment 66 may be discarded. In implementations in which the tray is reusable, the tray may be removed from the pump, the pumping segmentdetached and discarded, the tray cleaned, and then reused with a new infusion set and new pumping segment 66.
[0081] Many of the above-described devices, systems and methods, may also be controlled by 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.
[0082] 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 subject 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.
[0083] 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.
[0084] FIG. 8 is another example infusion pump, according to various aspects of the subject technology. A tray 300 is illustrated for drop in loading of an infusion administration set 66. In the depicted example, the tray 300 is integrated into the infusion pump 10. Similar to FIG. 4, the housing 122 encloses an air-in-line sensor 84 and a pressure sensor(s) 80, 82, with a pumping mechanism 304 (including motor block 126 and or pumping elements 72-28) positioned therebetween. The infusion administration set 66 can be received by an opening 306 in the infusion pump housing 122 and urged into place using a presser bar 308 on a hinged lid 310. In this regard, the lid 310 may replace the door 124 of FIG. 4 in that the lid is positioned to the side of the pumping mechanism 304, such that the infusion administration set 66 can be pushed laterally into opening 306 rather than a door 124 vertically pushing the set 66 against the pumping mechanism. In other words, the pumping region 304 may not press against the lid 310 but rather against a rigid planar surface within the pump, for example, an inner wall of housing 122, opposite the pumping mechanism 304.
[0085] In some implementations, the tray 300 may be a unit that is dropped into a pump, as a cartridge. In this regards, the depicted housing 122 may be inserted into a like opening within the pump 10, whereby the depicted pumping mechanism 304 may receive the various components of the motor block, such as the occluder(s) 72, 76 and / or pumping finger(s) 74, 78. In some implementations, the depicted pumping mechanism 304 may include one or more openings that align with and / or receive pumping elements 72-28 of the pump’s pumping mechanism when the tray 300 is inserted into the pump 10. In this regard, the depicted pumping mechanism 304 may include the flexible membrane 121 of FIG. 4 such that the entire tray 300 is fluidically isolated from the mechanical and electrical components of the pump 10 (e.g., shown in FIG. 4).
[0086] FIG. 9 is a conceptual diagram illustrating an example electronic system 600 for operating an infusion pump 10 with an infusion set loading tray, according to aspects of the subject technology. Electronic system 600 may be representative of a control unit and / or computing device for execution of software associated with one or more components and processes provided by FIGS. 1 through 8, including but not limited to infusion pump 10 (e.g., a processing system of controller 14 or within infusion pump 10) or a electromechanical system for opening and closing the disclosed loading tray drawer 200. Electronic system 600 may be representative of a device used in connection or combination with the disclosure regarding FIGS. 1 through 7. In this regard, electronic system 600 may be a device connected to theinfusion pump 10, for example, to activate the occluders and / or pumping fingers, the cam 142, or to monitor or control same. For example, system 600 may be representative of a personal computer or a mobile device such as a smartphone, tablet computer, laptop, personal digital assistant (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 specifically configured to implement one or more of the features described.
[0087] 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 processes previously described.
[0088] Bus 608 collectively represents all system, peripheral, and chipset buses that communicatively connect the numerous internal devices of electronic system 600. For instance, bus 608 communicatively connects processing unit(s) 612 with ROM 610, system memory 604, and permanent storage device 602.
[0089] From these various memory units, processing unit(s) 612 retrieves specific 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.
[0090] 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.
[0091] 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 permanentstorage 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 as randomaccess 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.
[0092] 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.
[0093] Also, as shown in FIG. 9, 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, a personal area network (“PAN”), 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.
[0094] The 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.
[0095] 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 specific instructions for performing various operations described herein. 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.
[0096] 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 (FPGAs) specifically configured with one or more of the features described. In some implementations, such integrated circuits execute instructions that are stored on the circuit itself.
[0097] 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 of people. For the purposes of the 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.
[0098] To provide for interaction with a user, implementations of the subject matter described in this specification can be implemented on a specifically configured 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 specifically configured 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.
[0099] Implementations of the subject matter described in this specification can be implemented in a specifically configured 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 inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).
[0100] The computing system can include clients and servers. A client and server are generally remote from each other (e.g., physically separated) 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 implementations, 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.
[0101] 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.
[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] Illustration of Subject Technology as Clauses:
[0104] 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 identifications.
[0105] Clause 1. An apparatus for loading a pumping segment of an infusion set into an infusion pump, comprising: a rigid surface comprising one or more supports configured to align and constrain the pumping segment in a fixed linear position; and one or more alignment features configured to, when the apparatus is inserted within the infusion pump, align the constrained pumping segment with respect to a pumping mechanism of the infusion pump and the rigid surface, wherein the apparatus is configured to be inserted into and removed from the infusion pump and to engage the constrained pumping segment with the pumping mechanism when inserted and to disengage the constrained pumping segment from the pumping mechanism when removed.
[0106] Clause 2. The apparatus of Clause 1, wherein the rigid surface comprises a tubing support surface, and wherein the one or more supports are configured to align and constrain the pumping segment in the fixed linear position against the tubing support surface such that a compression force that is applied upon the pumping segment by the pumping mechanism froma side of the pumping segment opposite the tubing support surface compresses the pumping segment against the tubing support surface.
[0107] Clause 3. The apparatus of Clause 1 or Clause 2, wherein the one or more alignment features are further configured to align the constrained pumping segment with at least one of an air-in-line sensing component of the infusion pump and a pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump.
[0108] Clause 4. The apparatus of Clause 3, wherein the rigid surface further comprises respective cutouts in respective regions under the constrained pumping segment that correspond to one or more of the air-in-line sensing component of the infusion pump, the pumping mechanism of the infusion pump, and the pressure sensing component of the infusion pump.
[0109] Clause 5. The apparatus of any one of Clauses 1-4, further comprising: a flange circumscribing the rigid surface; and one or more first recesses in a topmost surface of the apparatus and configured to accommodate one or more of a first air-in-line sensing component of the infusion pump, the pumping mechanism, and a first pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump; and one or more second recesses in a bottom surface of the apparatus and configured to accommodate one or more of a corresponding second air-in-line sensing component of the infusion pump and a corresponding second pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump.
[0110] Clause 6. The apparatus of any one of Clauses 1-5, wherein the one or more alignment features comprises a linear slot.[OHl] Clause 7. The apparatus of any one of Clauses 1-6, wherein the apparatus further comprises: a disposable air-in-line sensing component that is in a predetermined fixed position with respect to the constrained pumping segment such that, when the apparatus is inserted into the infusion pump, the disposable air-in-line sensing component is aligned with and communicates with a corresponding non-disposable air-in-line sensing component of the infusion pump to cause detection of air within a portion of the pumping segment when the air is present.
[0112] Clause 8. The apparatus of any one of Clauses 1-7, wherein the loading tray further comprises: a disposable pressure sensing component that is in a predetermined fixed position with respect to the constrained pumping segment such that, when the apparatus is inserted into the infusion pump, the disposable pressure sensing component is aligned with and communicates with a corresponding non-disposable pressure sensing component of the infusion pump to cause detection of a fluid pressure within the pumping segment.
[0113] Clause 9. The apparatus of any one of Clauses 1-8, wherein the apparatus is built into the infusion pump and comprises a sliding track or a pivot that provides movement of the apparatus into and out of the infusion pump for engagement and disengagement of the pumping segment with the pumping mechanism of the infusion pump.
[0114] Clause 10. The apparatus of Clause 9, wherein the apparatus comprises the sliding track and the apparatus or the sliding track interacts with a spring and a latch to allow for the apparatus to be ejected from the infusion pump when the latch is released and then pushed back into a locked position in the infusion pump and locked in the locked position by the latch.
[0115] Clause 11. The apparatus of Clause 10, further comprising: a locking feature located on a bottom surface of the apparatus and configured to lock into a corresponding recess within the infusion pump to lock the apparatus into the locked position and to align the constrained pumping segment with the pumping mechanism and at least one of the air-in-line sensor and the pressure sensor when the apparatus is inserted within the infusion pump, wherein the locking feature is configured such that to remove the apparatus from the infusion pump the apparatus is lifted out of the locking position.
[0116] Clause 12. The apparatus of any one of Clauses 9-11, wherein the infusion pump comprises: an actuator configured to, when the apparatus is being disengaged from the infusion pump, move at least one sensor component or the pumping mechanism away from the apparatus and the pumping segment and, when the apparatus is being inserted into the infusion pump, move the at least one sensor component or the pumping mechanism toward the apparatus and the pumping segment to engage the pumping segment.
[0117] Clause 13. A fluid administration set comprising: a fluid tubing configured to receive a fluid from a fluid source and to deliver the fluid to a target by way of being compressed by a peristaltic pump; the apparatus of any one of Clauses 1-8.
[0118] Clause 14. A system comprising: the infusion pump of Clause 1; and the apparatus of any one of Claims 1-12.
[0119] Clause 15. A method, comprising: providing the apparatus of any one of Clauses 1- 12.
[0120] Clause 16. The apparatus of any one of Clauses 1-15, wherein the apparatus is an infusion set loading tray.
[0121] Further Consideration:
[0122] In some embodiments, any of the clauses herein may depend from any one of the independent clauses or any one of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) may be combined with any other one or more clauses (e.g., dependent or independent clauses). In one aspect, a claim may include some or all of the words (e.g., steps, operations, means or components) recited in a clause, a sentence, a phrase or a paragraph. In one aspect, a claim may include some or all of the words recited in one or more clauses, sentences, phrases or paragraphs. In one aspect, some of the words in each of the clauses, sentences, phrases or paragraphs may be removed. In one aspect, additional words or elements may be added to a clause, a sentence, a phrase or a paragraph. In one aspect, the subject technology may be implemented without utilizing some of the components, elements, functions or operations described herein. In one aspect, the subject technology may be implemented utilizing additional components, elements, functions or operations.
[0123] 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 subj ect technology, and the subj ect 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.
[0124] The term website, as used herein, may include any aspect of a website, including one or more web pages, one or more servers used to host or store web related content, etc. Accordingly, the term website may be used interchangeably with the terms, web page and server. 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™, web services, or rich site summary (RSS). In some implementations, 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, diagnostic device, monitoring device, or server in communication therewith.
[0125] 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.
[0126] 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.
[0127] As used 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 orrelationship 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.
[0128] 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 “implementation” does not imply that such implementation is essential to the subject technology or that such implementation applies to all configurations of the subject technology. A disclosure relating to an implementation may apply to all implementations, or one or more implementations. An implementation may provide one or more examples. A phrase such as an “implementation” may refer to one or more implementations 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.
Claims
WHAT IS CLAIMED IS:
1. An apparatus for loading a pumping segment of an infusion set into an infusion pump, comprising: a rigid surface comprising one or more supports configured to align and constrain the pumping segment in a fixed linear position; and one or more alignment features configured to, when the apparatus is inserted within the infusion pump, align the constrained pumping segment with respect to a pumping mechanism of the infusion pump and the rigid surface, wherein the apparatus is configured to be inserted into and removed from the infusion pump and to engage the constrained pumping segment with the pumping mechanism when inserted and to disengage the constrained pumping segment from the pumping mechanism when removed.
2. The apparatus of Claim 1, wherein the rigid surface comprises a tubing support surface, and wherein the one or more supports are configured to align and constrain the pumping segment in the fixed linear position against the tubing support surface such that a compression force that is applied upon the pumping segment by the pumping mechanism from a side of the pumping segment opposite the tubing support surface compresses the pumping segment against the tubing support surface.
3. The apparatus of Claim 1 or Claim 2, wherein the one or more alignment features are further configured to align the constrained pumping segment with at least one of an air-in-line sensing component of the infusion pump and a pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump.
4. The apparatus of Claim 3, wherein the rigid surface further comprises respective cutouts in respective regions under the constrained pumping segment that correspond to one or more of the air-in-line sensing component of the infusion pump, the pumping mechanism of the infusion pump, and the pressure sensing component of the infusion pump.
5. The apparatus of any one of Claims 1-4, further comprising: a flange circumscribing the rigid surface; andone or more first recesses in a topmost surface of the apparatus and configured to accommodate one or more of a first air-in-line sensing component of the infusion pump, the pumping mechanism, and a first pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump; and one or more second recesses in a bottom surface of the apparatus and configured to accommodate one or more of a corresponding second air-in-line sensing component of the infusion pump and a corresponding second pressure sensing component of the infusion pump when the apparatus is inserted within the infusion pump.
6. The apparatus of any one of Claims 1-5, wherein the one or more alignment features comprises a linear slot.
7. The apparatus of any one of Claims 1-6, wherein the apparatus further comprises: a disposable air-in-line sensing component that is in a predetermined fixed position with respect to the constrained pumping segment such that, when the apparatus is inserted into the infusion pump, the disposable air-in-line sensing component is aligned with and communicates with a corresponding non-disposable air-in-line sensing component of the infusion pump to cause detection of air within a portion of the pumping segment when the air is present.
8. The apparatus of any one of Claims 1-7, wherein the loading tray further comprises: a disposable pressure sensing component that is in a predetermined fixed position with respect to the constrained pumping segment such that, when the apparatus is inserted into the infusion pump, the disposable pressure sensing component is aligned with and communicates with a corresponding non-disposable pressure sensing component of the infusion pump to cause detection of a fluid pressure within the pumping segment.
9. The apparatus of any one of Claims 1-8, wherein the apparatus is built into the infusion pump and comprises a sliding track or a pivot that provides movement of the apparatus into and out of the infusion pump for engagement and disengagement of the pumping segment with the pumping mechanism of the infusion pump.
10. The apparatus of Claim 9, wherein the apparatus comprises the sliding track and the apparatus or the sliding track interacts with a spring and a latch to allow for the apparatus tobe ejected from the infusion pump when the latch is released and then pushed back into a locked position in the infusion pump and locked in the locked position by the latch.
11. The apparatus of Claim 10, further comprising: a locking feature located on a bottom surface of the apparatus and configured to lock into a corresponding recess within the infusion pump to lock the apparatus into the locked position and to align the constrained pumping segment with the pumping mechanism and at least one of the air-in-line sensor and the pressure sensor when the apparatus is inserted within the infusion pump, wherein the locking feature is configured such that to remove the apparatus from the infusion pump the apparatus is lifted out of the locking position.
12. The apparatus of any one of Claims 9-11, wherein the infusion pump comprises: an actuator configured to, when the apparatus is being disengaged from the infusion pump, move at least one sensor component or the pumping mechanism away from the apparatus and the pumping segment and, when the apparatus is being inserted into the infusion pump, move the at least one sensor component or the pumping mechanism toward the apparatus and the pumping segment to engage the pumping segment.
13. A fluid administration set comprising: a fluid tubing configured to receive a fluid from a fluid source and to deliver the fluid to a target by way of being compressed by a peristaltic pump; and the apparatus of any one of Claims 1-8.
14. A system comprising: the infusion pump of Claim 1; and the apparatus of any one of Claims 1-12.
15. A method, comprising: providing the apparatus of any one of Claims 1-12.
Citation Information
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