Infusion Pump Sensing System

Abstract

A force sensing assembly for an infusion pump is provided. The force sensing assembly includes a processor and an occlusion sensor coupled to the processor. The occlusion sensor is positioned to oppose the occluder valve when the platen is closed. The force sensing assembly measures one or more forces exerted on the fluid tubing during a pump cycle. Also provided are an infusion pump assembly, a method for operating an infusion pump with a force sensing assembly, and a system for controlling an infusion pump and an infusion device.

Description

[Technical Field]

[0001] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 63 / 030,742, filed May 27, 2020, and entitled "INFUSION PUMP SENSING SYSTEM," the disclosure of which is incorporated herein by reference in its entirety and for all purposes.

[0002] The present disclosure relates generally to infusion pump sensing systems, and more particularly to thin film force sensor systems. [Background technology]

[0003] Flexible tubing for medical fluid infusion has been widely used in the medical field for intravenous (IV), epidural, and enteral applications. Such tubing can be used in typical infusion pumps, such as large volume pumps (LVPs). Infusion pumps typically use a linear peristaltic or similar type of mechanism to create a pumping action by squeezing the IV tubing and generating pressure to force IV medication through the IV tubing and ultimately into the patient. This squeezing action can also be used as a flow closure mechanism. This is used in pumping mechanisms that operate in a cyclical manner by operating in cycles that include a fill portion and a delivery portion. In these cases, the pumping mechanism uses valving that includes an inlet or fill valve and an outlet or delivery valve. Typical operation of a pumping mechanism generally requires the complete closure of these valves when they are not expected to be open. Incomplete closure can cause leaks, which can result in uncontrolled flow, resulting in either not enough medication or too much medication being delivered to the patient. Summary of the Invention [Problem to be solved by the invention]

[0004] To verify that the valving mechanism in an infusion pump is closing properly, the amount of force that needs to be applied to the tubing to ensure that it is pinched completely closed is very important. For this reason, verification that the valving mechanism is operating as expected is desirable. [Means for solving the problem]

[0005] One or more embodiments provide an infusion pump assembly according to some aspects of the present disclosure. The infusion pump assembly includes a body, a door, a tubing path configured to receive a fluid tube, a pumping mechanism having an occluder valve, a platen, and a force sensing assembly. The force sensing assembly includes a processor and an occlusion sensor coupled to the processor, the occlusion sensor positioned on the platen opposite the occluder valve when the platen is closed. The force sensing assembly is configured to measure one or more forces exerted on the fluid tube during a pump cycle.

[0006] One or more embodiments provide a force sensing assembly for an infusion pump according to some aspects of the present disclosure. The force sensing assembly includes a platen, upper and lower occlusion sensors disposed on the platen at locations configured to face corresponding upper and lower occluder valves of the infusion pump when the platen is in a closed position, and a processor electronically coupled to the occlusion sensors. The force sensing assembly is configured to measure one or more forces exerted on fluid tubing disposed between the occlusion sensors and the occluder valves during a pump cycle.

[0007] One or more embodiments provide a method of operating an infusion pump with a force sensing assembly according to some aspects of the present disclosure, including receiving a fluid tubing in a fluid flow path of the infusion pump, causing the infusion pump to perform one or more pumping cycles, each pumping cycle squeezing a portion of the fluid tubing to force fluid flow from an output end of the fluid tubing, measuring, with the force sensing assembly, the force on the fluid tubing during the pumping cycle, comparing the measured force to an established occlusion force threshold, and generating a fluctuation signal if a fluctuation outside the established occlusion force threshold is detected.

[0008] One or more embodiments provide an infusion pump with a force-sensing assembly for controlling, according to some aspects of the present disclosure, an infusion pump system including a force sensor disposed on a platen of the infusion pump opposite a pumping element of the infusion pump and configured to generate one or more force measurements applied during a pump cycle, and a processor configured with specific computer-executable instructions to receive a first force measurement from the force sensor, determine that the first force measurement corresponds to a threshold force value, generate a control message based at least on the first force measurement, and transmit at least the control message to the infusion pump, thereby causing the infusion pump associated with the force sensor to adjust its operation.

[0009] One or more embodiments provide an injection device according to some aspects of the present disclosure, including a transceiver for exchanging messages with a controller, a platen, a pumping element, a force sensor disposed on the platen opposite the pumping element and configured to generate one or more force measurements applied during a pump cycle, a non-transitory computer-readable data store configured to store specific computer-executable instructions, and a processor in communication with the non-transitory computer-readable data store, the processor configured to execute the computer-executable instructions. The instructions cause the transceiver to send a first message to the controller including the force measurements generated by the force sensor, receive a control message from the controller for adjusting an operational state of at least one hardware element of the injection device, and adjust the operational state of the at least one hardware element based at least in part on the control message.

[0010] These and other features, aspects, and advantages of the disclosed embodiments will become more apparent from the following detailed description and the accompanying drawings.

[0011] The accompanying drawings, which are included to provide a further understanding of the present disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the present disclosure and, together with the detailed description, serve to explain the principles of the present disclosure. [Brief explanation of the drawings]

[0012] [Figure 1] FIG. 1 is a front view of an exemplary patient care system having four fluid infusion pumps, each connected to a respective fluid source, for pumping the contents of the fluid source to a patient, according to some embodiments of the present disclosure. [Figure 2] FIG. 2 is a perspective view of one of the fluid infusion pumps of FIG. 1 according to some embodiments of the present disclosure. [Figure 3]FIG. 1 is a perspective view of a fluid infusion pump with a force sensor system according to some embodiments of the present disclosure. [Figure 4] FIG. 4 is a cross-sectional view from above of the fluid injection pump of FIG. 3 according to some embodiments of the present disclosure. [Figure 5] FIG. 1 is a perspective view of a platen assembly according to some embodiments of the present disclosure. [Figure 6] FIG. 1 is a perspective view of a fluid injection pump testing system with a force sensor system according to some embodiments of the present disclosure. [Figure 7] 7 is a graphical representation of force test results from the test system of FIG. 6, according to some embodiments of the present disclosure. [Figure 8] 1 is a flow diagram of a method of using a fluid infusion pump with a force sensor system according to some embodiments of the present disclosure. [Figure 9] 1 is a schematic diagram of a front view of a force sensor system according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] The detailed description provided below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details to provide a thorough understanding of the subject technology. Therefore, dimensions are provided for certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0014] It should be understood that the present disclosure includes examples of the subject technology, but does not limit the scope of the appended claims. Below, various aspects of the subject technology are disclosed according to detailed, but non-limiting examples. Various embodiments described in this disclosure can be implemented in different ways and variations according to a desired application or implementation.

[0015] Referring now in more detail to the drawings, in which like reference numerals used throughout the figures refer to like or corresponding elements, FIG. 1 illustrates a patient care system 20 having a controller 60 (e.g., control interface) and four infusion pumps 22, 24, 26, and 28, each fluidly connected to upstream fluid lines 30, 32, 34, and 36, respectively. The four infusion pumps 22, 24, 26, and 28 are also fluidly connected to downstream fluid lines 31, 33, 35, and 37, respectively. These fluid lines may be any type of fluid conduit through which fluid can flow, such as an intravenous (IV) administration set. It should be noted that any of a variety of pump mechanisms may be used, including syringe pumps.

[0016] The fluid sources 38, 40, 42, and 44 can take a variety of forms, but in this case are shown as bottles that are inverted and suspended above the pumps. The fluid sources can also take the form of bags or other types of containers, including syringes. Both the patient care system 20 and the fluid sources 38, 40, 42, and 44 can be mounted on roller stands, IV poles 46, tabletops, etc.

[0017] Separate infusion pumps 22, 24, 26, and 28 are used to infuse each of the fluid sources into the patient's body. These infusion pumps are flow control devices that act on the respective fluid lines to move fluid from the fluid sources through the fluid lines to the patient 48. Because separate pumps are used, each pump can be individually set to the pumping or operating parameters required to infuse a particular medical fluid from each fluid source into the patient's body at a particular rate prescribed for that fluid by a physician. Such medical fluids may include medications, nutrients, or other fluids.

[0018] Fluid sources 38, 40, 42 and 44 are each coupled to an electronic data tag 81, 83, 85 and 87, respectively, or to an electronic transmitter. Any device or component associated with the infusion system may be equipped with an electronic data tag, reader or transmitter.

[0019] Typically, medical fluid administration sets have many more parts than are shown in Figure 1. Many have check valves, drip chambers, valves with injection ports, connectors, and other devices well known to those skilled in the art. These other devices are not included in the drawings to maintain clarity of the illustration.

[0020] 2, infusion pump 22 having body 27 is shown in a perspective view with front door 50 open, showing upstream fluid line 30 and downstream fluid line 31 operatively engaged with pump 22. Infusion pump 22 acts directly on tubing 66 connecting upstream fluid line 30 to downstream fluid line 31 to form a continuous fluid conduit extending from the respective fluid source 38 to patient 48 (FIG. 1), through which fluid is acted upon by infusion pump 22 to move the fluid downstream to patient 48. In particular, pumping mechanism 70 acts as a flow control device for infusion pump 22 to move fluid through the conduits. Upstream and downstream fluid lines 30, 31 and / or tubing 66 may be coupled to a pump cassette or cartridge configured to be coupled to infusion pump 22.

[0021] The type of pumping mechanism can vary, for example, it can be a multi-finger pumping mechanism. For example, the pumping mechanism can be of the "four-finger" type, including an upstream occlusion finger 72, a primary pumping finger 74, a downstream occlusion finger 76, and a secondary pumping finger 78. This "four-finger" pumping mechanism, and those used in other linear peristaltic pumps, operates by using cam-driven pumping fingers to sequentially depress a segment of the fluid conduit, occluding fingers 72, 74, 76, and 78. Pressure is applied to successive locations on the conduit, starting at the upstream end of the pumping mechanism and moving toward the downstream end. At least one finger is always depressing hard enough to occlude the conduit. As a practical matter, one finger will not retract from occluding the tubing until the next finger in the sequence occludes the tubing; therefore, at any time, there is no direct fluid path from the fluid source to the patient. The operation of peristaltic pumps, including four-finger pumps, is well known to those skilled in the art, and therefore no further details regarding their operation will be provided herein.

[0022] 2 further illustrates a downstream pressure sensor 82 included in pump 22 at a downstream position relative to the pumping mechanism. Downstream pressure sensor 82 is mounted to flow control device 70 and is located adjacent to and downstream of flow control device 70. Because downstream pressure sensor 82 is located downstream of flow control device 70, i.e., at a location between patient 48 (FIG. 1) and flow control device 70, it allows connection of the correct fluid sources 38, 40, 42, and 44 to the correct pumps 22, 24, 26, and 28 to be confirmed before any fluid is delivered to patient 48.

[0023] 2 , an upstream pressure sensor 80 may also be included in pump 22. The upstream pressure sensor 80 is assigned to flow control device or pumping mechanism 70 and, in this embodiment, is also provided as an integral part of pump 22. It is mounted to flow control device 70 and is located adjacent to and upstream of flow control device 70. Because the upstream pressure sensor 80 is located upstream of flow control device 70, i.e., at a location between fluid source 38 ( FIG. 1 ) and flow control device 70, the connection of the correct fluid sources 38, 40, 42, and 44 to the correct pumps 22, 24, 26, and 28 may be confirmed before any fluid is delivered to patient 48.

[0024] Pump 22, or portions of pump 22, may also be equipped with electronic data tags or data transmitters. For example, as shown in FIG. 2, pump 22 may be equipped with a data tag 89 or reader device 90 for providing or receiving infusion data. The data reader device may include an RFID reader (or receiver) or other wireless device compatible with the data tags associated with the fluid containers. The data transmitter may transmit interrogation signals to electronic data tags 81, 83, 85, and 87 associated with fluid containers 38, 40, 42, and 44 to obtain infusion data from those tags. Although referred to as a data transmitting device, RFID tag, or RFID transponder, the data transmitting device may also receive or read data, and may be writable.

[0025] Typically, medical tubing is a disposable product that is used once and then discarded. Medical tubing can be formed from any suitable material (e.g., soft PVC, silicone, TPV (EPDM+PP), TPU, TPS (SBS / SEBS / SIS / SEPS) and its blends with polyolefins, TPEE (polyether ester) rubber). As shown in FIG. 2 , medical tubing 66 can be inserted into or otherwise engaged with pump 22. Pump 22 can include any of a large-volume, patient-controlled analgesia (PCA), ambulatory, or insulin pump that drives tubing segments to deliver controlled amounts of medication or nutrients into a patient's body. Medical tubing 66 is compressed when pump door 50 is closed. With pump door 50 in the closed position, medical tubing 66 is constrained within gap 54 and directly contacts upstream force sensor 80. As previously discussed, there are many sources of variability in measuring the force on medical tubing 66 by sensor 80.

[0026] According to aspects of the present disclosure, proper operation of an infusion pump valve can involve measuring the reaction force from the tubing when it is compressed. For example, a force sensor assembly can measure that reaction force and compare the measured force to a known value to determine if the valve is operating as expected.

[0027] As shown in FIGS. 3-5 , infusion pump 122 having body 127 is shown in a perspective view with front door 150 open, illustrating upstream fluid line 130 and downstream fluid line 131 operatively engaged with infusion pump 122. Infusion pump 122 acts directly on tubing 166 disposed within tubing path 154, connecting upstream fluid line 130 to downstream fluid line 131 to form a continuous fluid conduit. This continuous fluid conduit may extend from fluid source 38 ( FIG. 1 ) to patient 48, through which fluid is acted upon by infusion pump 122 to move the fluid downstream to patient 48. In particular, pumping mechanism 170 acts as a pump flow control device to move fluid through the conduits. Upstream and downstream fluid lines 130, 131 and / or tubing 166 may be coupled to a pump cassette or cartridge configured to be coupled to infusion pump 122.

[0028] Infusion pump 122 includes a stationary member, platen 155, and a moving member, pumping mechanism 170, that compresses tubing 166 against platen 155, creating a pinch and sealing the fluid path. Pumping mechanism 170 includes an upper occluder valve 172, a primary pumping finger 174, a lower occluder valve 176, and a secondary pumping finger 178.

[0029] The force sensing assembly 180 may be at least partially disposed on the platen 155. The force sensing assembly 180 includes an upper occlusion sensor 182 and a lower occlusion sensor 184 (e.g., force sensors). The upper and lower occlusion sensors 182, 184 are positioned on the platen 155 adjacent to (e.g., opposite) the upper and lower occlusion valves 172, 176, respectively, when the platen 155 is in a closed position covering the pumping mechanism 170. In this manner, the tube 166 is sandwiched or engaged between the platen 155 and the pumping mechanism 170. The force sensing assembly 180 is configured to be unobtrusive and not present any uneven surfaces that could interfere with proper sandwiching of the tube 166. Here, the upper and lower occlusion sensors 182, 184 are each piezoresistive thin-film elements that present a substantially flat, unobtrusive surface.

[0030] In some aspects of the present disclosure, the force sensing assembly 180 is coupled via wiring 188 or other coupling (e.g., circuitry, wireless) to a processor 186. The processor 186 provides modulation and signal conditioning to provide an understandable signal that is used by the software of the infusion pump 122 to determine the operational status of the upper and lower occluder valves 172, 176, and then to make a decision as to whether to stop the infusion pump 122 and / or generate an alarm to notify the user of an abnormal condition.

[0031] As shown in FIG. 4 , processor 186 may be enclosed within housing 187 located on an exterior portion of infusion pump 122. In some embodiments of the present disclosure, processor 186 may be integral with the processor of infusion pump 122, or processor 186 may be the main processor that operates infusion pump 122. In some embodiments of the present disclosure, force sensing assembly 180 may be an integral component of infusion pump 122, where the processor of infusion pump 122 is configured to execute the operations of infusion pump 122 and provide force sensing measurements and calculations based on force sensing assembly 180. In some embodiments of the present disclosure, force sensing assembly 180 may be an add-on component configured to function with any type of infusion pump. Here, add-on force sensing assembly 180 may include a replacement platen 155 pre-configured with upper and lower occlusion sensors 182, 184, wiring 188, and housing 187 containing processor 186. Housing 187 can be configured to couple to any infusion pump (e.g., infusion pump 122) via any desired coupling (e.g., clip, screw, glue). In this manner, upper and lower occlusion sensors 182, 184 can be integrated into platen 155 and can measure the reaction force from tubing 166 when corresponding upper and lower occlusion valves 172, 176 are actuated.

[0032] FIG. 6 shows a perspective view of an exemplary system including a fluid infusion pump with a force sensor system according to some embodiments of the present disclosure. System 200 illustrates a configuration of features including force sensing assembly 180 of infusion pump 122. The configuration of FIG. 6 illustrates how force sensing assembly 180 can be added to infusion pump 122. For example, force sensing assembly 180 can include a force sensing disk that can be secured to a pump platen on the door of infusion pump 122. This force sensing disk can include a conductive element for receiving power or data from a control device. This conductive element can additionally or alternatively be used to transmit force data generated by the force sensing disk to the control device.

[0033] FIG. 7 is a graphical representation of force test results from the test system of FIG. 6 , according to some embodiments of the present disclosure. A test system such as test system 200 can be used to test force sensing assembly 180 of infusion pump 122. Testing using test system 200 provides a graphical representation or curve 300 of force test results of a typical force signal over time for infusion pump 122 operating at a nominal flow rate of 125 mL / hr. From this signal information, the force of upper occluder valve 172 and the operation of primary pumping finger 174 can be distinguished. Force test results can be compared to expected values ​​or ranges of values ​​to detect deviations from the expected values.

[0034] For example, the pump cycle 310 of curve 300 has a first portion 320 in which the upper occluder valve 172 is closed, generating a force of 10.7 N (=2.4 lbf). A second portion 330 shows the additional force from the primary pumping finger 174 being fully extended while the upper occluder valve 172 is closed, generating a total force of 25.4 N (5.7 lbf). A third portion 340 shows the upper occluder valve 172 being open with an IV set (e.g., tubing 166) loaded, the front door 150 and platen 155 closed, generating a force of 4.26 N (0.95 lbf). Here, the IV set has a fluid pressure of approximately 6894 Pa (1 psi). Thus, the force is a result of a combination of fluid pressure, the contact surface area of ​​the tubing 166, and the proximity of the upper occlusion sensor 182 to the primary pumping finger 174. Here, the detected or measured force value may indicate a fault in the upper or lower occluder valve 172, 176 or a broken platen 155.

[0035] The shape of curve 300 can also be used to gather information about the condition of tube 166, since the rate of change of compression and relaxation can provide information about whether tube 166 is of the correct thickness and whether the material stretches as expected for tube 166. In this manner, the detected or measured force value can detect incomplete occlusion of tube 166 as a result of tube 166 being improperly positioned or having a tube dimension outside of a specified range.

[0036] Using artificial intelligence (AI) or machine learning algorithms, the shape information of curve 300 can be compared to previous curves from a device (e.g., infusion pump 122) or to a population of infusion pumps in the field to identify other abnormal conditions, such as wear in pumping mechanism 170. This can be used as a preventative measure to identify infusion pumps that should be serviced or removed from service before a failure occurs.

[0037] 8 illustrates a method 800 for operating an infusion pump with a force sensing assembly. The exemplary method 800 may be performed, in whole or in part, by one or more of the devices described herein, such as those shown in the patient care system 20 of FIG. 1. In some implementations, the method may be performed, in whole or in part, by a remote device that receives input messages from and provides output messages to other devices, such as those included in the patient care system 20 of FIG. 1, or by another device accessible by one or more devices included in the patient care system 20.

[0038] In step 810, tubing (e.g., tube 166) is placed or positioned in a fluid flow path of an infusion pump (e.g., infusion pump 122). For example, the tubing can be inserted into the open fluid flow path of the infusion pump, and then the infusion pump door (e.g., front door 150) can be closed to secure the tubing within the fluid flow path of the infusion pump between a platen (e.g., platen 155) and a pump component (e.g., pumping mechanism 170). The infusion pump is cycled (e.g., pump cycle 310) in step 820. For example, the infusion pump can generate a compressive force to squeeze any or all of the tubing in the fluid flow path, causing fluid within the tubing to flow out of the tubing and out of the infusion pump. This compressive force can be a repetitive force, with each compression being a pump cycle. In step 830, the force on the tubing (e.g., first portion 320, second portion 330, third portion 340) during the pump cycle is measured by a sensing assembly (e.g., force sensing assembly 180).

[0039] In step 840, the measured force is compared by a processor (e.g., processor 186) to an established occlusion force threshold. For example, the measured force may be compared to an expected value or range of values ​​based on pump and tubing specifications. In step 850, a variation outside the established occlusion force threshold is detected by the same or another processor (e.g., processor 186, the processor of infusion pump 122). In step 860, if a variation outside the established occlusion force threshold is detected, a variation signal is generated. For example, the variation signal may be a fault signal due to less than complete occlusion of the tubing during the occlusion portion of the pump cycle, improper positioning of the tubing, improper sizing of the tubing, a broken or damaged platen, and / or a broken or damaged occluder valve.

[0040] In step 870, an alarm may be generated based on the generated variability signal. The alarm may be a human-perceptible indication of the variability, including one or more of an audio, visual, or tactile representation. For example, the alarm may be generated on a display of the infusion pump and / or user device.

[0041] In some implementations, it may be desirable to adjust the operation of the pump based on the variability signal. This adjustment may include generating a control message to adjust one or more elements of the infusion pump or an associated patient care system. For example, in step 880, the infusion pump is stopped based on the generated variability signal. For example, software on the infusion pump may automatically stop the pump upon generation or receipt of the variability signal. In another example, the infusion pump may be manually stopped by a user based on receipt of an alarm.

[0042] As discussed above, the type of pumping mechanism can vary, for example, a multi-finger pumping mechanism having fewer or more fingers than a "four-finger" configuration. For example, as shown in FIG. 9 , the pumping mechanism can be a linear peristaltic mechanism 970 (e.g., a valve, an occluder) having 12 fingers 972. A force sensing assembly 980 can be disposed at least partially on the pump platen (platen 155). The force sensing assembly 980 can include one or more occlusion sensors 982. For example, 12 occlusion sensors 982 can be positioned adjacent to (e.g., across from) corresponding fingers 972 on the platen 155 when the platen 155 is in a closed position covering the pumping mechanism 970. Any other configuration of occlusion sensors can also be provided. For example, one long occlusion sensor could cover the entire length of twelve fingers 972, with each finger 972 positioned across from a different portion of its single occlusion sensor 982. A tube (e.g., tube 166) is sandwiched or engaged between platen 155 and pumping mechanism 970. Force sensing assembly 980 is configured to be unobtrusive and not create uneven surfaces that could interfere with proper sandwiching of tube 166. Here, occlusion sensors 982 can each be a piezoresistive thin film element that creates a substantially flat, unobtrusive surface. Force sensing assembly 980 can measure the resulting occlusion force as it moves along the length of tube 166. The force measurements can then be compared to an acceptable force level to determine if the system is operating properly.

[0043] Variations on the steps of the devices and methods discussed above may be provided by certain aspects of the present disclosure. For example, a controller may include a processor configured, with specific computer-executable instructions, to at least receive a first force measurement from the force sensor, determine that the first force measurement corresponds to a threshold force value, generate a control message based at least on the first force measurement, and cause an infusion pump associated with the occlusion sensor to adjust operation by transmitting the control message to the infusion pump. The controller may also receive, from the force sensor or the infusion pump, an identifier for a fluid to be infused by a pump cycle and retrieve, from a data store, a threshold force value based at least in part on the identifier for the fluid. The controller may also receive, from the sensor or the infusion pump, an identifier for tubing used to infuse the fluid during a pump cycle and retrieve, from a data store, a threshold force value based at least in part on the identifier for the tubing. The controller may also generate the control message by at least one of including a first value in the control message to adjust an output element of the infusion pump to provide a human-perceivable indication of a potential error and including a second value in the control message to adjust a pumping element of the infusion pump, including at least one of a power supply, a motor, a pumping finger, or a safety valve, to prevent additional pumping cycles.

[0044] As another example, a transceiver (e.g., a transceiver in an infusion pump) may be included to exchange messages with a controller. A non-transitory computer-readable data store may be configured to store certain computer-executable instructions, and a processor may be in communication with the non-transitory computer-readable data store. The processor may be configured to at least cause the transceiver to send a first message to the controller including a force measurement generated by the force sensor, receive a control message from the controller for adjusting an operational state of at least one hardware element of the infusion device, and execute the computer-executable instructions to adjust the operational state of the at least one hardware element based at least in part on the control message.

[0045] As used herein, the terms "control" or "controlling" encompass a wide variety of actions. For example, "controlling" a device may include sending one or more messages to adjust the operating state or functional elements of the device. The messages may include specific instructions that are executed by the device's processor to make the changes manifest. "Controlling" may include storing a value in a storage device location for later retrieval by the controlled device, directly transmitting a value to the controlled device via at least one wired or wireless communication medium, transmitting or storing a reference to a value, etc. For example, a control message may include a value for adjusting the level of power from a power source of the controlled device. As another example, a control message may activate or deactivate a structural element of the controlled device, such as a light, audio playback, a motor, a lock, a pump, a display, or other component of a device described herein. "Controlling" may include indirect control of a device by adjusting a setpoint used by the controlled device. For example, a control message may include a threshold for a device characteristic (e.g., temperature, speed, frequency, etc.). The threshold value may be stored in a memory location and referenced by the controlled device during operation.

[0046] According to some aspects of the present disclosure, a pump assembly includes a fluid flow pump, a tubing pathway configured to receive a fluid tube, and a tubing dimensioning assembly including a processor, an emitter spaced from the tubing pathway and configured to generate an emission into the tubing pathway, and a collector spaced from the tubing pathway and configured to receive the emission from the emitter, the tubing dimensioning assembly further configured to measure an outer diameter (OD) of the tubing received in the pathway, the measurement based at least in part on the emission.

[0047] It is understood that any particular order or hierarchy of blocks in the disclosed process methods is an example of an example approach. Based on design or implementation preferences, it is understood that the particular order or hierarchy of blocks in the processes may be rearranged, or that not all illustrated blocks may be performed. In some implementations, any of the blocks may be performed simultaneously.

[0048] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure 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.

[0049] Reference to a singular element is not intended to mean "one and only one" unless specifically stated otherwise, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include the feminine and neuter genders (e.g., her and its) and vice versa. Headings and subheadings, if present, are used for convenience only and do not limit the invention.

[0050] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In some aspects, various alternative configurations and operations described herein may be considered at least equivalent.

[0051] As used herein, the phrase "at least one of" preceding a list of items and followed by the word "or" separating any of the items does not modify each item in the list, but rather modifies the list as a whole. The phrase "at least one of" does not require the selection of at least one item, but rather may mean including at least one of any of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" may refer to A only, B only, or C only, or any combination of A, B, and C.

[0052] A phrase such as "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. Disclosure of an aspect may apply to all configurations, or to 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 "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. Disclosure of an embodiment may apply to all embodiments, or to 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 "configuration" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more instances. A phrase such as a configuration may refer to one or more configurations, and vice versa.

[0053] As used herein, the phrase "determine" or "determining" encompasses a wide variety of actions. For example, "determining" can include calculating, computing, processing, deriving, generating, obtaining, referencing (e.g., referencing in a table, database, or another data structure), ascertaining, etc., via a hardware element without user intervention. Also, "determining" can include receiving (e.g., receiving information), accessing (accessing data in memory), etc., via a hardware element without user intervention. "Determining" can include resolving, selecting, choosing, establishing, etc., via a hardware element without user intervention.

[0054] As used herein, the phrase "provide" or "providing" encompasses a wide variety of actions. For example, "providing" may include storing a value at a location on a storage device for later retrieval, transmitting a value directly to a recipient via at least one wired or wireless communication medium, transmitting or storing a reference to a value, etc. "Providing" may also include encoding, decoding, encrypting, decrypting, verifying, authenticating, inserting, etc. via a hardware element.

[0055] As used herein, the term "message" encompasses a wide variety of formats for communicating (e.g., sending or receiving) information. A message may include a machine-readable collection of information, such as an XML document, a fixed-field message, a comma-separated message, or the like. A message, in some implementations, may include signals used to transmit one or more representations of information. Even when written in the singular, it will be understood that a message may be composed, transmitted, stored, received, etc., as multiple parts.

[0056] In certain aspects, unless stated otherwise, all measurements, values, orders, positions, dimensions, sizes, and other specifications given in this specification, including the following claims, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and with that which is customary in the art to which they pertain.

[0057] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of sample approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying method claims (if any) present the various steps, operations, or process elements in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0058] All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed pursuant to 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for" or, in the case of a method claim, unless the element is recited using the phrase "step for." Furthermore, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive, similar to the term "comprise" when interpreted as a transitional phrase in a claim.

[0059] In any embodiment, data may be transferred to a "remote device or location," where "remote" means a location or device separate from the location or device where the program is executed. For example, a remote location may be a different location in the same city (e.g., an office, laboratory, etc.), a different location in a different city, a different location in a different state, a different location in a different country, etc. Thus, when an item is described as being "remote" from another item, what is meant is that the two items may be in the same room and separate, or may be in different rooms or different buildings and separate by at least 1 mile, 10 miles, or 100 miles. "Communicating" information refers to transmitting data representing that information as electrical signals over an appropriate communications channel (e.g., a private or public network). "Transmitting" an item refers to any means of moving the item from one location to another, whether by physically carrying the item or (possibly) otherwise, and includes, at least in the case of data, physically transporting the medium carrying the data or communicating the data. Examples of communication media include radio or infrared transmission channels, as well as network connections between another computer or networked device and the Internet, or the transmission of email, information stored on a website, etc.

[0060] Some embodiments include implementations in a single computer, across a network of multiple computers, or across a network of multiple networks of multiple computers, including, for example, across a network cloud, across a local area network, or in a handheld controller device. The computer can be a physical machine or a virtual machine hosted on another computer. In some embodiments, one or more of the steps described herein are implemented in a computer program. Such a computer program performs one or more of the steps described herein. In some embodiments, implementations of the subject methods include various data structures, categories, and qualifiers described herein, encoded on a computer-readable medium and transmittable over a communications network.

[0061] Software, web, internet, cloud or other storage, and computer network implementations of the present invention may be achieved using standardized programming techniques specifically configured to cause one or more devices to perform the various allocation, calculation, identification, scoring, accessing, generating, or destroying steps described.

[0062] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples, not as a limiting description of the disclosure. They are submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, the detailed description can be seen to provide exemplary illustrations, and that various features have been grouped together in various embodiments to streamline the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in fewer than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0063] The claims are not intended to be limited to the embodiments described herein, but are to be accorded the full scope consistent with the claims and encompass all legal equivalents. Nevertheless, no claim is intended, and should not be construed, to cover subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. The main body and Doors and a tubing pathway configured to receive a fluid tube; a pumping mechanism having an occluder valve; A platen and 1. A force sensing assembly comprising: processor, and an occlusion sensor coupled to the processor, the occlusion sensor positioned on the platen opposite the occluder valve when the platen is closed; a force sensing assembly configured to measure one or more forces exerted on the fluid tube during a pump cycle; Equipped with based on the one or more forces measured by the force sensing assembly a malfunction of the occluder valve; The platen is broken; and Incomplete occlusion of the fluid tube caused by one of improper positioning of the fluid tube in the tubing path and fluid tube dimensions outside of a specified range. One of configured to detect Infusion pump assembly.

2. The infusion pump assembly of claim 1 , wherein the occlusion sensor is coupled to the processor by a wire.

3. The infusion pump assembly of claim 1 , wherein the processor is disposed within a housing coupled to an exterior portion of the body.

4. The infusion pump assembly of claim 1 , wherein the occlusion sensor comprises a piezoresistive thin film element.

5. 2. The infusion pump assembly of claim 1, wherein the pumping mechanism comprises upper and lower occluder valves, and the force sensing assembly comprises upper and lower occlusion sensors positioned opposite the upper and lower occluder valves.

6. 10. The infusion pump assembly of claim 1, wherein the processor is configured to provide modulation and signal conditioning used by infusion pump software.

7. The infusion pump assembly of claim 1 , wherein a processor controlling operation of the infusion pump assembly includes the processor of the force sensing assembly.

8. The infusion pump assembly of claim 1 , wherein the force sensing assembly is configured to measure the force on the fluid tube when the occluder valve is closed.

9. 2. The infusion pump assembly of claim 1, wherein the pumping mechanism comprises pumping fingers, and the force sensing assembly is configured to measure the force on the fluid tube when the pumping fingers are fully extended and the occluder valve is closed.

10. The infusion pump assembly of claim 1 , wherein the force sensing assembly is configured to measure a force on the fluid tube when the occluder valve is open.

11. The infusion pump assembly of claim 1 , configured to generate a force signal curve over time.

12. The infusion pump assembly of claim 11, further comprising: a first infusion pump assembly configured to compare the generated force signal curve over time with one or more force signal curves previously generated for the infusion pump assembly; and to identify an abnormal condition of the infusion pump assembly based on the comparison.

13. The infusion pump assembly of claim 1, configured to one of generate an alarm and automatically stop the infusion pump assembly based on the signal generated by the force sensing assembly.

14. 1. A force sensing assembly for an infusion pump, comprising: A platen and upper and lower occlusion sensors, respectively, disposed on the platen at locations configured to face corresponding upper and lower occluder valves of an infusion pump when the platen is in a closed position; a processor electronically coupled to said upper and lower occlusion sensors; It is equipped with the force sensing assembly is configured to measure one or more forces exerted on fluid tubing disposed between the upper and lower occlusion sensors and the upper and lower occluder valves during a pump cycle; based on the one or more forces measured by the force sensing assembly a failure of one of the upper and lower obturator valves; The platen is broken; and Incomplete occlusion of the fluid tube caused by one of improper positioning of the fluid tube in the infusion pump and fluid tube dimensions outside a specified range. One of configured to detect are Force sensing assembly.

15. 15. The force sensing assembly of claim 14, wherein the upper and lower occlusion sensors each include a piezoresistive thin film element.

16. 1. A method of operating an infusion pump with a force sensing assembly, comprising: receiving a fluid tube in a fluid flow path of the infusion pump; causing the infusion pump to perform one or more pumping cycles, each pumping cycle squeezing a portion of the fluid tubing to force fluid flow from an output end of the fluid tubing; measuring the force on the fluid tube during the pumping cycle with the force sensing assembly; Based on the force measured by the force sensing assembly Faulty occluder valve, The platen is damaged, and Incomplete occlusion of the fluid tube caused by one of improper positioning of the fluid tube in the fluid flow path and fluid tube dimensions outside of a specified range. One of detecting comparing the measured force to an established closure force threshold value; generating a variation signal if a variation outside the established occlusion force threshold is detected; A method comprising:

17. generating an alarm based on the generated fluctuation signal; stopping the infusion pump based on the generated fluctuation signal; 17. The method of claim 16, further comprising one of:

18. 1. A system for controlling an infusion pump, comprising: a force sensor disposed on a platen of the infusion pump opposite a pumping element of the infusion pump and configured to generate one or more force measurements applied during a pump cycle; The specific computer-executable instructions at least: receiving a first force measurement from the force sensor; determining that the first force measurement corresponds to a threshold force value; generating a control message based at least on the first force measurement; transmitting at least the control message to the infusion pump, thereby causing the infusion pump to coordinate its operation; a controller including a processor configured to Equipped with The controller executes at least the following steps according to the specific computer-executable instructions: receiving from the force sensor or the infusion pump one of an identifier for a fluid to be infused by the pump cycle and an identifier for tubing used to infuse fluid during the pump cycle; retrieving the force value threshold from a data store based at least in part on one of the identifier for the fluid and the identifier for the tubing; It is configured as ru, system.

19. The controller, in accordance with the specific computer-executable instructions, including a first value in the control message to adjust an output element of the infusion pump to provide a human-perceptible indication of a potential error; including a second value in the control message to adjust a pumping element of the infusion pump, including at least one of a power supply, a motor, a pumping finger, or a safety valve, to prevent additional pumping cycles; 20. The system of claim 18, configured to generate the control message by at least one of:

20. 1. An injection device comprising: a transceiver for exchanging messages with the controller; A platen and A pumping element; a force sensor disposed on the platen opposite the pumping element and configured to generate one or more force measurements applied during a pump cycle; a non-transitory computer-readable data store configured to store specific computer-executable instructions; a processor in communication with the non-transitory computer-readable data store, the processor comprising at least: causing the transceiver to send a first message to the controller, the first message including a force measurement produced by the force sensor; Based on the force measurement Faulty occluder valve, The platen is damaged, and Incomplete occlusion of the fluid tube caused by one of improper positioning of the fluid tube in the fluid flow path and dimensions of the fluid tube outside of a specified range. One of Detects receiving a control message from the controller for adjusting an operational state of at least one hardware element of the injection device; adjusting the operational state of the at least one hardware element based at least in part on the control message; a processor configured to execute the computer-executable instructions to An injection device comprising:

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