Infusion pump sensing system

By introducing force sensing components and a processor system into the infusion pump, the force changes during the pumping process can be monitored and adjusted in real time, solving the problem of incomplete valve closure in the infusion pump, ensuring accurate drug delivery and reducing leakage, and improving the reliability of the infusion process.

CN115916288BActive Publication Date: 2026-04-14CAREFUSION 303 INC
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
CAREFUSION 303 INC
Filing Date
2021-05-19
Publication Date
2026-04-14

AI Technical Summary

Technical Problem

The valve mechanism of existing infusion pumps may not close completely when shutting down, leading to drug leakage or inaccurate delivery. There is a lack of effective force sensing methods to verify the operating status of the valves.

Method used

The system employs force sensing components, including upper and lower blockage sensors, to measure the force on the fluid pipe. Combined with a processor and controller, it monitors and adjusts force changes in the pumping cycle in real time, generating alarms or adjusting pumping operations.

Benefits of technology

It enables real-time monitoring and adjustment of infusion pump valves, ensuring accurate drug delivery, reducing leakage, and improving the reliability and safety of the infusion process.

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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 opposite the occluder valve when the platen is closed. The force sensing assembly measures one or more forces exerted on a fluid tube during a pumping cycle. Methods of operating an infusion pump having a force sensing assembly, systems for controlling an infusion pump and an infusion device are also provided.
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Description

Technical Field

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 63 / 030,742 entitled “Infusion Pump Sensing System”, filed May 27, 2020, pursuant to 35 USC §119, the entire contents of which are incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure generally relates to infusion pump sensing systems, particularly thin-film element force sensor systems. Background Technology

[0004] Tubing for medical fluid infusion is widely used in the medical field for intravenous (IV), epidural, and enteral applications. This tubing can be used with typical infusion pumps, such as high-volume pumps (LVPs). Infusion pumps typically use a linear peristaltic or similar mechanism that generates pressure by squeezing the IV tubing, creating a pumping action that causes the IV medication to flow through the tubing and ultimately into the patient. The squeezing action can also be used as a flow-closing mechanism. This is used in pumping mechanisms that operate in a cyclic manner by functioning in a circulation (comprising an infusion section and a delivery section). In these cases, the pumping mechanism uses valves including an inlet valve or infusion valve and an outlet valve or delivery valve. Typical operation of a pumping mechanism usually requires these valves to be completely closed when they are not intended to be opened. Incomplete closure can cause leakage, which can lead to uncontrolled flow, resulting in insufficient or excessive medication being delivered to the patient.

[0005] To verify that the valve mechanism in the infusion pump closes correctly, it is crucial to apply the appropriate amount of force to the tubing to ensure it is compressed and fully closed. Therefore, it is essential to verify that the valve mechanism operates as expected. Summary of the Invention

[0006] According to aspects of this disclosure, one or more embodiments provide an infusion pump assembly. The infusion pump assembly includes a body, a door, a conduit path configured to receive a fluid tube, a pumping mechanism having an occluder valve, a pressure plate, and a force sensing assembly. The force sensing assembly includes a processor and an occlusion sensor coupled to the processor, the occlusion sensor being positioned on the pressure plate opposite the occluder valve when the pressure plate is closed. The force sensing assembly is configured to measure one or more forces applied to the fluid tube during a pumping cycle.

[0007] According to aspects of this disclosure, one or more embodiments provide a force sensing assembly for an infusion pump. The force sensing assembly includes a pressure plate, an upper occlusion sensor, and a lower occlusion sensor, each occlusion sensor being positioned on the pressure plate in a closed position, configured to be opposite to corresponding upper and lower occlusion valves of the infusion pump, and a processor electrically coupled to the occlusion sensor. The force sensing assembly is configured to measure one or more forces applied to a fluid line disposed between the occlusion sensor and the occlusion valve during a pumping cycle.

[0008] According to aspects of this disclosure, one or more embodiments provide a method of operating an infusion pump having a force sensing component. The method includes receiving a fluid tube in a fluid flow path of the infusion pump; causing the infusion pump to perform one or more pumping cycles, wherein each pumping cycle forces fluid to flow from an output end of the fluid tube by squeezing a portion of the fluid tube; during the pumping cycle, measuring a force on the fluid tube by the force sensing component; comparing the measured force to the predetermined obstruction force threshold; and generating a change signal if a change exceeding the predetermined obstruction force threshold is detected.

[0009] According to aspects of this disclosure, one or more embodiments provide a system for controlling an infusion pump having a force-sensing component. The system includes a force sensor disposed on the pressure plate of the infusion pump opposite to a pumping element of the infusion pump, wherein the force sensor is configured to generate a measurement of one or more forces applied during a pumping cycle, and the controller includes a processor configured with specific computer-executable instructions. Instructions receive a first force measurement from the force sensor; determine that the first force measurement corresponds to a force value threshold; generate a control message based at least on the first force measurement; and cause the infusion pump associated with the force sensor to adjust its operation by at least transmitting the control message to the infusion pump.

[0010] According to aspects of this disclosure, one or more embodiments provide an infusion device. The infusion device includes a transceiver for exchanging messages with a controller, a pressure plate, a pumping element, a force sensor disposed on the pressure plate opposite to the pumping element, wherein the force sensor is configured to generate a measurement of one or more forces applied during a pumping cycle, a non-transitory computer-readable data memory configured to store specific computer-executable instructions, and a processor communicating with the non-transitory computer-readable data memory, the processor being configured to execute the computer-executable instructions. The instructions cause the transceiver to transmit a first message to the controller, the first message including the force measurement generated by the force sensor; receive from the controller a control message for adjusting the operating state of at least one hardware element of the infusion device; and adjust the operating state of at least one hardware element at least in part based on the control message.

[0011] The foregoing and other features, aspects and advantages of the disclosed embodiments will become more apparent from the following detailed description and accompanying drawings. Attached Figure Description

[0012] 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 specification, serve to explain the principles of the present disclosure.

[0013] Figure 1 A front view of an example patient care system having four fluid infusion pumps according to some aspects of this disclosure is depicted, each fluid infusion pump being connected to a corresponding fluid supply unit for pumping the contents of the fluid supply unit to the patient.

[0014] Figure 2 Depicting aspects according to this disclosure Figure 1 A perspective view of one of the fluid infusion pumps.

[0015] Figure 3 A perspective view of a fluid infusion pump with a force sensor system according to aspects of this disclosure is depicted.

[0016] Figure 4 Depicting aspects according to this disclosure Figure 3 A top view of the cross-section of a fluid infusion pump.

[0017] Figure 5 A perspective view of a pressure plate assembly according to aspects of this disclosure is depicted.

[0018] Figure 6 A perspective view of a test system for a fluid infusion pump with a force sensor system according to aspects of this disclosure is depicted.

[0019] Figure 7 It is based on aspects of this disclosure. Figure 6 Graphical representation of the force test results of the test system.

[0020] Figure 8 A flowchart is provided illustrating a method for using a fluid infusion pump with a force sensor system according to aspects of this disclosure.

[0021] Figure 9 A front schematic diagram of a force sensor system according to aspects of this disclosure is depicted. Detailed Implementation

[0022] The detailed description below illustrates various configurations of the subject matter and is not intended to represent the only configuration in which the subject matter can be practiced. The detailed description includes specific details for the purpose of providing a comprehensive understanding of the subject matter. Therefore, the dimensions provided with respect to particular aspects are non-limiting examples. However, it will be apparent to those skilled in the art that the subject matter can be practiced without these specific details. In some cases, well-known structures and components are shown in the form of block diagrams to avoid obscuring the concepts of the subject matter.

[0023] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter will now be disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure may be implemented in different ways and variations, and depending on the desired application or implementation.

[0024] Referring now to the accompanying drawings in more detail, similar reference numerals refer to similar or corresponding elements in the various views. Figure 1 The diagram illustrates a patient care system 20 with a controller 60 (e.g., a control interface) and four infusion pumps 22, 24, 26, and 28, each fluidly connected to upstream fluid lines 30, 32, 34, and 36, respectively. Each of the four infusion pumps 22, 24, 26, and 28 is also fluidly connected to downstream fluid lines 31, 33, 35, and 37, respectively. The fluid lines can be any type of fluid conduit, such as an IV delivery device, through which fluid can flow. It should be understood that any of a variety of pumping mechanisms can be used, including infusion pumps.

[0025] Fluid supply units 38, 40, 42, and 44 can take various forms, but in this case they are shown as bottles, which are inverted and suspended above the pump. Fluid supply units can also take the form of bags or other types of containers, including syringes. The patient care system 20 and fluid supply units 38, 40, 42, and 44 are mounted on roller frames, IV stands 46, desktops, etc.

[0026] Individual infusion pumps 22, 24, 26, and 28 are used to infuse each fluid from the fluid supply unit to the patient. The infusion pumps are flow-controlled devices that act on the corresponding fluid lines to move fluid from the fluid supply unit through the fluid lines to the patient 48. Because individual pumps are used, each pump can be individually set to the pumping or operating parameters required to infuse a specific medical fluid from the corresponding fluid supply unit to the patient at a specific rate prescribed by the physician for that fluid. Such medical fluids may include medications, nutrients, or other fluids.

[0027] Fluid supply components 38, 40, 42, and 44 are each coupled to electronic data tags 81, 83, 85, and 87, or to electronic transmitters, respectively. Any device or component associated with the infusion system may be equipped with an electronic data tag, reader, or transmitter.

[0028] Typically, medical fluid delivery devices have a higher efficiency than... Figure 1 More components are shown. Numerous devices are included, such as check valves, drip chambers, valves with inlets, connectors, and other devices well known to those skilled in the art. These other devices are not included in the figures to maintain clarity of illustration.

[0029] Now go to Figure 2 With the front door 50 open, the infusion pump 22 with body 27 is shown in the perspective view, along with an upstream fluid line 30 and a downstream fluid line 31 operatively engaged with the pump 22. The infusion pump 22 acts directly on a tube 66 connecting the upstream fluid line 30 to the downstream fluid line 31 to form a continuous fluid conduit extending from the respective fluid supply unit 38 to the patient 48. Figure 1 The infusion pump 22 acts on the fluid through the fluid conduit to move the fluid downstream to the patient 48. Specifically, the pumping mechanism 70 acts as a flow control device for the infusion pump 22 to move the fluid through the conduit. Upstream and downstream fluid lines 30, 31 and / or tube 66 may be coupled to a pump housing or canister, which are configured to be coupled to the infusion pump 22.

[0030] The type of pumping mechanism can vary and can be, for example, a multiple-finger pumping mechanism. For instance, the pumping mechanism can be of a "four-finger" type and includes an upstream blocking finger 72, a main pumping finger 74, a downstream blocking finger 76, and a secondary pumping finger 78. The "four-finger" pumping mechanism and other mechanisms used in linear peristaltic pumps are operated by means of cams that follow the pumping fingers and blocking fingers 72, 74, 76, and 78 in sequence to press a section of the fluid conduit. Pressure is applied to the sequential position of the conduit, starting from the upstream end of the pumping mechanism and working towards the downstream end. At least one finger is always pressed with sufficient force to block the conduit. As a practical problem, a finger may not retract from the blocked tube until the next finger in the sequence has blocked the tube, thus there is no direct fluid path from the fluid supply to the patient at any given time. The operation of peristaltic pumps including four-finger pumps is well known to those skilled in the art, and further operational details are not provided here.

[0031] Figure 2A downstream pressure sensor 82, included in pump 22, is also shown, located downstream of the pumping mechanism. The downstream pressure sensor 82 is mounted to flow control device 70 and is located adjacent to and downstream of flow control device 70. The downstream pressure sensor 82 is located downstream of flow control device 70, i.e., downstream of patient 48. Figure 1 The position between the fluid supply units 38, 40, 42 and 44 and the flow control device 70 allows the correct connection of the fluid supply units 38, 40, 42 and 44 to the correct pumps 22, 24, 26 and 28 to be verified before any fluid is pumped to the patient 48.

[0032] Still referencing Figure 2 An upstream pressure sensor 80 may also be included in the pump 22. The upstream pressure sensor 80 is assigned to the flow control device or pumping mechanism 70, and in this embodiment, is also provided as a component of the pump 22. It is mounted on the flow control device 70 and located adjacent to and upstream of the flow control device 70. The upstream pressure sensor 80 is located upstream of the flow control device 70, i.e., upstream of the fluid supply unit 38. Figure 1 The position between the fluid supply units 38, 40, 42 and 44 and the flow control device 70 allows the correct connection of the fluid supply units 38, 40, 42 and 44 to the correct pumps 22, 24, 26 and 28 to be verified before any fluid is pumped to the patient 48.

[0033] Pump 22 or a portion thereof may also be equipped with an electronic data tag or data transmitter. For example, such as Figure 2 As shown, 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 these tags. Although referred to as a data transmitter, RFID tag, or RFID repeater, the data transmitter may also receive or read data and may be writable.

[0034] Medical tubing is typically a single-use product, discarded after a single application. It can be formed from any suitable material (e.g., soft PVC, silicone, TPV (EPDM+PP), TPU, TPS (SBS / SEBS / SIS / SEPS) and mixtures with polyolefins, TPEE (polyether ester) rubber). Figure 2As shown, the medical tubing 66 can be inserted into or otherwise engaged with pump 22. Pump 22 can include any of the following: high-capacity, patient-controlled analgesia (PCA), mobile pump, or insulin pump, which drives one or more tubing segments to deliver medication or nutrients to a patient in a controlled manner. When pump door 50 is closed, medical tubing 66 is compressed. With pump door 50 closed, medical tubing 66 is constrained within gap 54 and in direct contact with upstream force sensor 80. As discussed above, there are many sources of variation when measuring the force on medical tubing 66 via sensor 80.

[0035] According to aspects of this disclosure, proper operation of an infusion pump valve can be achieved by measuring the reaction force from the tubing when it is compressed. For example, a force sensor assembly can measure the reaction force and then compare the measured force with a known value to determine whether the valve is operating as intended.

[0036] like Figures 3 to 5 As shown, with the front door 150 open, an infusion pump 122 with a body 127 is shown in the perspective view, along with an upstream fluid line 130 and a downstream fluid line 131 operatively engaged with the infusion pump 122. The infusion pump 122 acts directly on a pipe 166 arranged within a conduit passage 154 and connects the upstream fluid line 130 to the downstream fluid line 131 to form a continuous fluid conduit. The continuous fluid conduit can be drawn from a fluid supply unit 38 ( Figure 1 Extending to patient 48, the infusion pump 122 acts fluid through this fluid conduit to move fluid downstream to patient 48. Specifically, the pumping mechanism 170 serves as a flow control device for the pump to move fluid through the conduit. Upstream and downstream fluid lines 130, 131 and / or tube 166 may be coupled to a pump housing or canister, which are configured to be coupled to the infusion pump 122.

[0037] The infusion pump 122 includes a pressure plate 155 as a static component and a pumping mechanism 170 as a moving component. The pumping mechanism 170 presses the tubing 166 against the pressure plate 155 to create compression and seal the fluid passage. The pumping mechanism 170 includes an upper plug valve 172, a main pumping finger 174, a lower plug valve 176, and a secondary pumping finger 178.

[0038] Force sensing assembly 180 may be at least partially arranged on pressure plate 155. Force sensing assembly 180 includes an upper blockage sensor 182 and a lower blockage sensor 184 (e.g., force sensors). The upper blockage sensor 182 and the lower blockage sensor 184 are positioned on pressure plate 155 such that when pressure plate 155 is in the closed position covering pumping mechanism 170, they are adjacent (e.g., opposite) to upper plug valve 172 and lower plug valve 176, respectively. Thus, tube 166 is clamped or engaged between pressure plate 155 and pumping mechanism 170. Force sensing assembly 180 is configured to be non-protruding and does not create uneven surfaces that could prevent proper clamping of tube 166. Here, both upper blockage sensor 182 and lower blockage sensor 184 are piezoresistive thin-film elements that produce generally smooth and non-protruding surfaces.

[0039] In some aspects of this disclosure, the force sensing component 180 is coupled to the processor 186 via a wire 188 or other coupler (e.g., circuitry, wireless). The processor 186 provides modulation and signal conditioning to provide an understandable signal used by the infusion pump 122 software to determine the operating status of the upper occluder valve 172 and the lower occluder valve 176, and then makes a decision on whether to stop the infusion pump 122 and / or generate an alarm to notify the user of the abnormal condition.

[0040] like Figure 4 As shown, processor 186 can be enclosed within housing 187 arranged on the exterior of infusion pump 122. In this aspect of the disclosure, processor 186 can be integrated with the processor of infusion pump 122, and processor 186 can be the main processor operating infusion pump 122. In this aspect of the disclosure, force sensing component 180 can be an integral part of infusion pump 122, wherein one or more infusion pump 120 processors are configured to operate infusion pump 112 and provide force sensing measurements and calculation results based on force sensing component 180. In this aspect of the disclosure, force sensing component 180 can be an additional component configured to work with any type of infusion pump. Here, additional force sensing component 180 can include replacement pressure plate 155 pre-configured with upper occlusion sensor 182, lower occlusion sensor 184 and wire 188, and housing 187 containing processor 186. The housing 187 can be configured to couple with any infusion pump (e.g., infusion pump 122) via any desired coupling (e.g., clamping, screwing, adhesive). Therefore, the upper occlusion sensor 182 and the lower occlusion sensor 184 can be integrated into the pressure plate 155 and measure the reaction force from the tube 166 when the corresponding upper occlusion valve 172 and lower occlusion valve 176 are actuated.

[0041] Figure 6A perspective view of an example system including a fluid infusion pump with a force sensor system, according to aspects of this disclosure, is depicted. System 200 shows the configuration of features of a force sensing component 180 including an infusion pump 122. Figure 6 The configuration shown illustrates how a force sensing assembly 180 can be added to an infusion pump 122. For example, the force sensing assembly 180 may include a force sensing disc that can be attached to a pumping plate on the door of the infusion pump 122. The force sensing disc may include conductive elements to receive electrical or data signals from a control device. The conductive elements may be additionally or alternatively used to transmit force data generated by the force sensing disc to the control device.

[0042] Figure 7 It is based on aspects of this disclosure. Figure 6 A graphical representation of the force test results from the testing system. A testing system such as testing system 200 can be used to test the force sensing component 180 of the infusion pump 122. Tests performed with testing system 200 provide a graphical representation or curve 300 of the typical force signal of the infusion pump 122 operating at a rated flow rate of 125 mL / hr over time. Based on this signal information, the force of the upper occluder valve 172 and the operation of the main pumping fingers 174 can be detected. The force test results can be compared with expected values ​​or numerical ranges to detect changes from one or more expected values.

[0043] For example, the pumping cycle 310 of curve 300 has a first section 320 in which the upper plug valve 172 is closed, generating a force of 2.4 lbf. The second section 330 shows the additional force generated when the upper plug valve 172 is closed, with the main pumping finger 174 fully extended, generating a total force of 5.7 lbf. The third section 340 shows a force of 0.95 lbf generated when the upper plug valve 172 is open (where the IV device (e.g., tube 166) is loaded) and the front door 150 and pressure plate 155 are closed. Here, the fluid pressure of the IV device is approximately 1 psi. Therefore, the force is a result of the combination of fluid pressure, the contact surface area of ​​tube 166, and the close proximity of the upper plug sensor 182 to the main pumping finger 174. Here, the detected or measured force value can indicate a malfunction of the upper plug valve 172 or the lower plug valve 176, or a breakage of the pressure plate 155.

[0044] The shape of curve 300 can also be used to gather information about the condition of tube 166, as the rate of change of compression and relaxation can provide information about whether tube 166 is of the correct thickness and whether the elastic properties of the material of tube 166 are not as expected. Therefore, the detected or measured force values ​​can detect incomplete blockage of tube 166 due to improper positioning or tube dimensions outside the specified range.

[0045] Using artificial intelligence (AI) or machine learning algorithms, the shape information of curve 300 can also be compared with previous curves from instruments (e.g., infusion pump 122) or with the group of infusion pumps in the field to identify other anomalies, such as wear on the pumping mechanism 170. This can be used as a predictive measure to identify infusion pumps that should be repaired or taken out of service before a failure occurs.

[0046] Figure 8 A method 800 for operating an infusion pump with a force-sensing component is illustrated. The exemplary method 800 can be performed wholly or partially by one or more devices described in this application, such as... Figure 1 The patient care system 20 is illustrated with the device shown. In some embodiments, all or part of the method can be performed by a remote device that receives input messages from other devices and provides output messages to other devices, such as those included in [the system]. Figure 1 The device in the patient care system 20 or another device that can be accessed by one or more devices included in the patient care system 20.

[0047] In step 810, a tube (e.g., tube 166) is placed or arranged in the fluid path of an infusion pump (e.g., infusion pump 122). For example, the tube can be inserted into the fluid path of an open infusion pump, and then the pump door (e.g., front door 150) can be closed to secure the tube within the fluid path of the infusion pump between a pressure plate (e.g., pressure plate 155) and a pumping component (e.g., pumping mechanism 170). In step 820, the infusion pump is circulated (e.g., pumping cycle 310). For example, the infusion pump can induce a compressive force to squeeze any or all of the tube in the fluid path, causing fluid in the tube to flow out of the tube leaving the infusion pump. The compressive force can be a recurring force, where each compression is a pumping cycle. In step 830, the force on the tube during the pumping cycle (e.g., first section 320, second section 330, third section 340) is measured by a sensing component (e.g., force sensing component 180).

[0048] In step 840, the measured force is compared by a processor (e.g., processor 186) to a predetermined obstruction force threshold. For example, the measured force may be compared to an expected value or range based on pump and tubing specifications. In step 850, a change exceeding the predetermined obstruction force threshold is detected by the same or another processor (e.g., processor 186, infusion pump 122 processor). In step 860, if a change exceeding the predetermined obstruction force threshold is detected, a change signal is generated. For example, the change signal may be a fault signal caused by: incomplete tubing blockage during a blocked portion of the pumping cycle, improper tubing positioning, improper tubing size, broken or damaged pressure plate, and / or broken or damaged plug valve.

[0049] In step 870, an alarm may be generated based on the generated change signal. The alarm may be a human-perceptible indication of change, including one or more of audio, visual, or policy representations. For example, an alarm may be generated on the display of the infusion pump and / or on the user's device.

[0050] In some implementations, it may be desirable to regulate pump operation based on a changing signal. This regulation may include generating control messages to adjust one or more components of the infusion pump or associated patient care system. For example, in step 880, the infusion pump is stopped based on the generated changing signal. For instance, the infusion pump's software may automatically stop the pump upon generating or receiving a changing signal. In another example, the infusion pump may be manually stopped by the user based on receiving an alarm.

[0051] As mentioned above, the type of pumping mechanism can vary, and it can be, for example, a multi-finger pumping mechanism with fewer or more fingers than a "four-finger" configuration. For example, such as Figure 9 As shown, the pumping mechanism can be a linear peristaltic mechanism 970 (e.g., a valve, a plug) with twelve fingers 972. A force sensing assembly 980 can be at least partially arranged on the pumping platen (e.g., platen 155). The force sensing assembly 980 can include one or more obstruction sensors 982. For example, twelve obstruction sensors 982 can be positioned on platen 155 such that when platen 155 is in the closed position covering the pumping mechanism 970, it is adjacent to (e.g., opposite to) the corresponding fingers 972. Any other configuration of the obstruction sensors can be configured. For example, a long obstruction sensor can cover the length of the twelve fingers 972, such that each finger 972 is positioned opposite a different portion of a single obstruction sensor 982. A tube (e.g., tube 166) is clamped or engaged between platen 155 and the pumping mechanism 970. The force sensing assembly 980 is configured not to protrude and not to create an uneven surface that could prevent proper compression of tube 166. Here, each of the obstruction sensors 982 can be a piezoresistive thin-film element, producing a generally smooth and non-protruding surface. The force sensing assembly 980 can measure the combined obstruction force as it travels along the length of the tube 166. The force measurement can then be compared with an acceptable force level to determine whether the system performs satisfactorily.

[0052] According to aspects of this disclosure, variations of the apparatus and method steps discussed above may be provided. For example, the controller may include a processor configured with specific computer-executable instructions to receive at least a first force measurement from a force sensor, determine that the first force measurement corresponds to a force threshold, generate a control message based at least on the first force measurement, and cause the infusion pump associated with the blockage sensor to regulate operation by transmitting the control message at least to the infusion pump. The controller may also receive from the force sensor or the infusion pump an identifier of the fluid infused by the pumping cycle and retrieve the force threshold from a data memory based at least in part on the fluid identifier. The controller may also receive from the sensor or the infusion pump an identifier of the tubing used to infuse fluid during the pumping cycle and retrieve the force threshold from a data memory based at least in part on the tubing identifier. The controller can also generate control messages by at least one of the following: including a first value in the control message to adjust the output element of the infusion pump, presenting an indication of a potential error that is perceptible to humans; and including a second value in the control message to adjust the pumping element of the infusion pump to prevent additional pumping cycles, wherein the pumping element includes at least one of a power supply, a motor, a pumping finger, or a safety valve.

[0053] As another example, a transceiver (e.g., an infusion pump transceiver) may be included for exchanging messages with a controller. A non-transitory computer-readable data memory may be configured to store specific computer-executable instructions, and a processor may communicate with the non-transitory data memory. The processor may be configured to execute the computer-executable instructions to at least cause the transceiver to transmit a first message to the controller, the first message including a force measurement generated by a force sensor, receiving a control message from the controller for adjusting the operating state of at least one hardware element of the infusion device, and adjusting the operating state of at least one hardware element at least in part based on the control message.

[0054] As used herein, the term "control" or "under control" encompasses a wide variety of actions. For example, "controlling" a device may include transmitting one or more messages to adjust the operating state or functional elements of the device. The message may include specific instructions to be executed by the device's processor to indicate the change. "Control" may include storing values ​​in a location in a storage device for subsequent retrieval by the controlled device, transmitting values ​​directly to the controlled device via at least one wired or wireless communication medium, transmitting or storing references to values, etc. For example, a control message may include a value for adjusting the power level from a power source supplied to the controlled device. As another example, a control message may activate or deactivate structural elements of the controlled device, such as lights, audio playback devices, motors, locks, pumps, displays, or other components of the device described herein. "Control" may include indirectly controlling the device by adjusting configuration values ​​used by the controlled device. For example, a control message may include threshold values ​​for device characteristics (e.g., temperature, rate, frequency, etc.). The threshold may be stored in a memory location and referenced by the controlled device during operation.

[0055] According to some aspects of this disclosure, the pump assembly includes a fluid flow pump, a conduit path configured to receive a fluid tube, and a pipe size measurement assembly. The pipe size measurement assembly includes: a processor; a transmitter spaced apart from the conduit path and configured to generate a projectile into the conduit path; and a collector spaced apart from the conduit path, arranged to receive the projectile from the transmitter, wherein the pipe size measurement assembly is further configured to measure the outer diameter (OD) of a tube accommodated in the path, said measurement being at least partially based on the projectile.

[0056] It should be understood that any specific order or hierarchy of blocks in the disclosed process is illustrative of the method. Based on design or implementation preferences, it should be understood that the specific order or hierarchy of blocks in the process may be rearranged, or all shown blocks may be executed. In some implementations, any block may be executed concurrently.

[0057] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject matter techniques, and the subject matter techniques are not limited to these examples. Various modifications to these aspects will be apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0058] Unless otherwise specified, references to singular elements do not mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" means one or more. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Titles and subtitles (if any) are for convenience only and do not limit the invention.

[0059] The term “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 one respect, the various alternative configurations and operations described herein may be considered at least equivalent.

[0060] As used herein, the phrase "at least one" preceding a list of items, separated by the term "or," modifies the list as a whole rather than each item in the list. The phrase "at least one" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one item from any given item and / or at least one item from any combination of items. For example, the phrase "at least one of A, B, or C" could refer to: only A, only B, or only C; or any combination of A, B, and C.

[0061] Phrases such as "aspect" do not imply that the aspect is essential to the subject matter or that the aspect is applicable to all configurations of the subject matter. Disclosures relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. Phrases such as "aspect" may refer to one or more aspects, or vice versa. Phrases such as "embodiment" do not imply that the embodiment is essential to the subject matter or that the embodiment is applicable to all configurations of the subject matter. Disclosures relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. Phrases such as "embodiment" may refer to one or more embodiments, or vice versa. Phrases such as "configuration" do not imply that such a configuration is essential to the subject matter or that such a configuration is applicable to all configurations of the subject matter. Disclosures relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. Phrases such as "configuration" may refer to one or more configurations, or vice versa.

[0062] As used herein, the terms "determine" or "determine" encompass a wide variety of actions. For example, "determine" can include performing calculations, operations, processing, derivation, generation, retrieval, searching (e.g., searching in a table, database, or other data structure), and ascertaining information via hardware components without user intervention. Furthermore, "determine" can include receiving (e.g., receiving information) and accessing (e.g., accessing data in memory) via hardware components without user intervention. "Determine" can also include parsing, selecting, picking, and building via hardware components without user intervention.

[0063] As used herein, the terms “providing” or “providing” encompass a wide variety of actions. For example, “providing” can 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” can also include encoding, decoding, encrypting, decrypting, authenticating, verifying, inserting, etc., via hardware components.

[0064] As used herein, the term "message" encompasses a variety of formats used to convey (e.g., send or receive) information. A message can include summaries of machine-readable information such as XML documents, fixed-field messages, comma-separated messages, etc. In some implementations, a message may include signals of one or more representations used to transmit information. Although stated in the singular, it is understood that a message can consist of multiple parts, be transmitted, stored, received, etc.

[0065] In one respect, unless otherwise stated, all measurements, values, ratings, positions, amplitudes, dimensions, and other specifications set forth in this specification (including the following claims) are approximate, not precise. In another respect, they are intended to have a reasonable range that is consistent with the functions they address and the conventions of the fields to which they pertain.

[0066] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is an illustration of an exemplary method. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes can be performed simultaneously. Some or all steps, operations, or processes can be performed automatically without user intervention. The appended method claims (if any) present the elements of the various steps, operations, or processes in a sample order, but this does not imply limitation to the presented specific order or hierarchy.

[0067] All structural and functional equivalents of elements throughout the various aspects described in this disclosure that are known or subsequently known to those skilled in the art are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, nothing disclosed herein is intended to be exclusive to the public, whether or not the disclosure is expressly stated in the claims. No claim element shall be construed pursuant to 35 U.S.SC § 112(f) unless the element is expressly stated using the phrase “means for…” or, in the case of a method claim, using the phrase “steps for…”. Furthermore, with regard to the use of the terms “comprising,” “having,” etc., when such terms are intended to be interpreted in a manner similar to the term “including,” as if “comprising” were used as a transitional word in a claim.

[0068] In any embodiment, data may be forwarded to a “remote” device or location, where “remote” means a location or device other than the location or device where the program is executed. For example, a remote location could be another location in the same city (e.g., an office, laboratory, etc.), another location in a different city, another location in a different state, another location in a different country, etc. Therefore, when an item is indicated as being “remote” to another item, it means that the two items may be in the same room but separated, or at least in different rooms or different buildings, and may be at least one mile, ten miles, or at least one hundred miles apart. “Transmitting” information refers to the transmission of data representing that information as an electrical signal via an appropriate communication channel (e.g., a private or public network). “Forwarding an item” refers to any means of moving the item from one location to another, whether by physical transmission or other means (if possible), at least in the case of data, including physically transmitting the medium carrying the data or conveying the data. Examples of communication media include radio or infrared transmission channels and network connections to another computer or networked device, as well as the Internet, or include email transmissions and recording information on websites, etc.

[0069] Some embodiments include implementations on a single computer, or across a network of computer networks, or across a network of computer networks, such as implementations across a network cloud, across a local area network, or across handheld computer devices. The computer may be a physical machine or a virtual machine hosted by another computer. In certain embodiments, one or more steps described herein are implemented on one or more computer programs. Such computer programs perform one or more steps described herein. In some embodiments, implementations of the subject method include the various data structures, categories, and modifiers described herein, which are encoded on one or more computer-readable media and can be transmitted over one or more communication networks.

[0070] The software, webpage, Internet, cloud or other storage and computer network implementations of the present invention can be implemented through standardized programming techniques, which are particularly suitable for enabling one or more devices to perform the various allocation, calculation, identification, scoring, access, generation or discard steps described.

[0071] The title, background, summary, description of drawings, and abstract of this disclosure are incorporated herein by reference and are provided as illustrative examples rather than limiting descriptions. It is understood at the time of filing that they are not intended to limit the scope or meaning of the claims. Furthermore, as will be apparent from the detailed description, it provides illustrative examples and, for the purpose of simplifying this disclosure, various features are summarized together in the various embodiments. The methods of this disclosure should not be construed as reflecting an intention to require more features than expressly recited in each claim. Rather, as reflected in the following claims, the inventive subject matter does not lie in all features of a single disclosed configuration or operation. The following claims are incorporated herein by reference in a detailed description, wherein each claim stands independently as a separate claimed subject matter.

[0072] The claims are not intended to be limited to the aspects described herein, but should be consistent with the full scope of the language of the claims and cover all legal equivalents. Nevertheless, the claims are not intended to include subject matter that does not comply with the requirements of 35 USC §101, 102, or 103, nor should they be construed in this manner.

Claims

1. An infusion pump assembly, comprising: main body; Door; Piping path configured to accommodate fluid conduits; Pumping mechanism with plug valve; Pressure plate; as well as Force sensing component, the force sensing component comprising: processor; and A blocking sensor coupled to the processor is positioned on the pressure plate opposite the plug valve when the pressure plate is closed. The force sensing component is configured to measure one or more forces applied to the fluid pipe during a pumping cycle. The infusion pump assembly is configured to generate a force signal over time curve, compare the generated force signal over time curve with one or more previously generated force signal over time curves of the infusion pump assembly, and identify abnormal conditions of the infusion pump assembly based on the comparison, wherein the abnormal conditions include at least the following: failure of the plug valve, breakage of the pressure plate, and incomplete blockage of the fluid tube, wherein the incomplete blockage is caused by one of incorrect positioning of the fluid tube in the pipeline path and tube size outside a specified range.

2. The infusion pump assembly according to claim 1, wherein, The blocking sensor is coupled to the processor via a wire.

3. The infusion pump assembly according to claim 1, wherein, The processor is housed within a housing that is coupled to an external portion of the main body.

4. The infusion pump assembly according to claim 1, wherein, The blocking sensor includes a piezoresistive thin-film element.

5. The infusion pump assembly according to claim 1, wherein, The pumping mechanism includes an upper plug valve and a lower plug valve, and the force sensing component includes an upper blockage sensor and a lower blockage sensor respectively arranged opposite to the upper plug valve and the lower plug valve.

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

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

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

9. The infusion pump assembly according to claim 1, wherein, The pumping mechanism includes pumping fingers, wherein the force sensing component is configured to measure the force on the fluid conduit when the pumping fingers are fully extended and the plug valve is closed.

10. The infusion pump assembly according to claim 1, wherein, The force sensing component is configured to measure the force on the fluid tube when the plug valve is open.

Citation Information

Patent Citations

  • In situ tubing measurements for infusion pumps

    US20100106082A1