Rapid occlusion detection in infusion devices

Abstract

The invention relates to a method for detecting an occlusion in a fluidic channel of an infusion device, comprising: flowing a fluid within the fluidic channel during a first time period, wherein a flow rate of the fluid is set to a first flow rate; pausing the flow rate for a second time period; measuring a first pressure at a location along the fluidic channel during the second time period; after measuring the first pressure, increasing the flow rate to a second flow rate; pausing the flow rate for a fourth time period; after pausing the flow rate, measuring a second pressure at the location during the fourth time period; calculating, at a processor, a difference between the first pressure and the second pressure; and providing an indication that an occlusion is present based on a determination that a magnitude of the difference satisfies a threshold.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 016,918, filed April 28, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application generally relates to detecting blockages in infusion devices. Background Technology

[0004] Medical devices, such as infusion devices, are used to deliver medical fluids to a patient. During operation of the infusion device, an obstruction (e.g., a blockage) can form along the infusion path along which the medical fluid is delivered to the patient (e.g., within an intravenous line), thereby interrupting the delivery of the medical fluid to the patient.

[0005] There is a need for faster detection of blockages in infusion devices in order to, for example, save device resources and minimize potential harm to patients. Summary of the Invention

[0006] Blockages in infusion lines (e.g., intravenous lines) can cause harm to patients due to treatment interruption and can lead to unintentional bolus infusions even after the blockage is cleared. It is desirable to detect blockages as early as possible to minimize the size of such unintentional and potentially harmful boluses. The earlier a blockage is detected, the smaller the total bolus volume infused to the patient after clearance. Similarly, early detection of blockages reduces the harmful effects of infusion interruptions on patients. Furthermore, early detection of blockages can reduce pressure on pumps, thus saving resources required for fluid delivery, such as power, pump motor circulation, and wear on pump fingers. Additionally, early detection can reduce strain on the fluid delivery components (e.g., fittings) by quickly identifying pressure events and taking corrective action to prevent further pressure increases and, in some cases, reduce pressure within the assembly. Therefore, methods and systems capable of detecting blockages more quickly to reduce their harmful effects are needed.

[0007] Time to Alarm (TTA) describes the time from the onset of an obstruction (upstream and / or downstream) in the infusion pathway to the time the infusion device issues an alarm to alert the clinician or patient. Table 1-3 shows typical TTA and bolus size after obstruction clearance for large volume pumps (LVPs) and infusion pumps. TTA values ​​for both LVPs and infusion pumps can reach several hours. Unintentional bolus volumes in infusion pumps can be as high as 1 ml, and in LVPs as high as 0.6 ml.

[0008]

[0009] Table 1 TTA for downstream occlusion and upstream occlusion in LVPs.

[0010]

[0011] Table 2 TTA for syringe pumps with and without pressure disk.

[0012]

[0013] Table 3 Unintentional bolus amount released after release of occlusion for LVP pumps and syringe pumps.

[0014] The methods and systems described herein allow for faster detection of occlusion conditions in infusion pumps. The methods and systems are applicable to all infusion pumps, including large volume pumps (LVPs) and syringe pumps. For example, the methods are capable of detecting downstream occlusion and upstream occlusion conditions in LVP pumps, including LVP pumps of different technologies, such as peristaltic pumps, piston pumps, and diaphragm pumps, among others. Thus, the methods are not limited to infusion pumps of any particular technology. The methods described herein take advantage of the difference in the measured dynamic force (or pressure) when an infusion pump is in an occlusion condition compared to when the infusion pump is operating in a normal infusion condition without occlusion. Using a specific diagnostic (e.g., probe) flow rate profile, the methods generate a measurable pressure signal that distinguishes between an occlusion condition and a normal infusion condition.

[0015] The methods and systems disclosed herein allow for earlier detection of occlusion conditions in infusion devices. The methods are particularly helpful in reducing (e.g., significantly reducing) TTAs at low flow rates compared to conventional systems. Although the description below focuses on detection of downstream occlusion conditions, the methods are equally applicable to upstream occlusion detection.

[0016] The disclosed subject matter relates to a method for detecting an occlusion in a jet flow channel in an infusion device. According to some implementations, the method includes calculating, at a processor, a difference between a first pressure at a location along the jet flow channel during a first time interval and a second pressure at the location during a second time interval later than the first time interval. The method includes determining whether a magnitude of the difference satisfies a threshold value, and in accordance with a determination that the magnitude of the difference satisfies the threshold value: providing an indication of a presence of an occlusion at an output of the infusion device. The first time interval is separated from the second time interval by a third interval. A first flow rate during the first time interval and a second flow rate during the second time interval are both lower than a third flow rate during the third time interval.

[0017] The disclosed subject matter also relates to a machine-readable medium containing instructions that, when executed by a machine, cause the machine to perform a method for detecting an occlusion as described herein.

[0018] The disclosed subject matter also relates to a system for detecting an occlusion. The system includes one or more processors and a memory including instructions that, when executed by the one or more processors, cause the one or more processors to perform the steps of the methods described herein.

[0019] The subject technology provides a system for detecting an occlusion, the system including one or more processors and a memory. The memory includes instructions that, when executed by the one or more processors, cause the one or more processors to calculate a difference between a first pressure at a location along a jet stream channel during a first time interval and a second pressure at the location during a second time interval later than the first time interval; determine whether a magnitude of the difference satisfies a threshold; and in accordance with a determination that the magnitude of the difference satisfies the threshold: provide an indication that an occlusion exists along the jet stream channel. The first time interval is separated from the second time interval by a third interval, a first flow rate during the first time interval and a second flow rate during the second time interval are both lower than a third flow rate during the third time interval. Other aspects include corresponding methods, apparatus, and computer program products for implementing the corresponding systems and features thereof.

[0020] It is understood that other configurations of the subject technology will become readily apparent to those skilled in the art from the following detailed description, wherein various configurations of the subject technology are shown and described by way of illustration. As will be realized, the subject technology is capable of other and different configurations and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. BRIEF DESCRIPTION OF DRAWINGS

[0021] For a better understanding of the various implementations described herein, reference should be made to the following descriptions taken in connection with the accompanying drawings. In all the drawings and descriptions, like reference numerals refer to the same or corresponding components throughout the specification and figures.

[0022] Figure 1A is an example patient care system including an infusion device.

[0023] Figure 1B is Figure 1A is a close-up view of a portion of the patient care system shown.

[0024] Figure 1C Examples of institutional patient care systems of healthcare organizations in accordance with aspects of the subject technology are described.

[0025] Figure 2 is an example syringe infusion pump that can detect an occlusion condition in accordance with aspects of the subject technology.

[0026] Figure 3AA method for detecting downstream blockage using a fixed-point blocking threshold is described.

[0027] Figure 3B A method for detecting upstream blockage using a fixed-point blocking threshold is described.

[0028] Figure 4 The flow velocity distribution curves are described based on various aspects of the technology in this subject.

[0029] Figure 5A Described Figure 4 The downstream pump pressure (or force) distribution curve shown is the velocity distribution curve.

[0030] Figure 5B The downstream pump pressure (or force) distribution curve describes an alternative flow velocity distribution curve.

[0031] Figure 6 Described Figure 4 The velocity distribution curve shown is the upstream pump pressure (or force) distribution curve in the LVP pump.

[0032] Figure 7 This is a flowchart illustrating a method for detecting blockages according to various aspects of the art in this subject matter.

[0033] Figure 8 The diagram shows two consecutive flow pulses at a programmed flow rate in an LVP pump.

[0034] Figure 9 This shows the effect during normal operation when there is no obstruction. Figure 8 The flow velocity distribution curve shown is the output of the downstream pump pressure sensor in the LVP pump.

[0035] Figure 10A yes Figure 9 A magnified view of the portion.

[0036] Figure 10B This shows the effect of downstream congestion. Figure 8 The flow velocity distribution curve shown is the output of the downstream pump pressure sensor in the LVP pump.

[0037] Figure 11 This shows the effect during normal operation when there is no obstruction. Figure 8 The velocity distribution curve shown is the output of the upstream pressure sensor in the LVP pump.

[0038] Figure 12 This shows the effect of upstream congestion. Figure 8 The velocity distribution curve shown is the output of the upstream pump pressure sensor in the LVP pump.

[0039] Figure 13An exemplary method for detecting occlusions in accordance with aspects of the subject technology is described.

[0040] Figure 14 is a conceptual diagram illustrating an exemplary electronic system for automatically adjusting control of a medical device in response to detecting a hostile environment in accordance with aspects of the subject technology. DETAILED DESCRIPTION

[0041] Reference will now be made to implementations, examples of which are illustrated in the accompanying drawings. In the following description, numerous specific details are set forth in order to provide an understanding of the various implementations described herein. However, it will be apparent to one skilled in the art that the various implementations described herein can be practiced without such specific details. In other instances, well-known methods, procedures, components, circuits, and networks have not been described in detail so as not to unnecessarily obscure aspects of the implementations.

[0042] Figure 1A is an exemplary patient care system in accordance with aspects of the subject technology. Figure 1A The illustrated patient care system 20 includes four fluid infusion pumps 22, 24, 26, and 28, each in operable engagement with a respective fluid administration set 30, 32, 34, and 36. Fluid supply sources 38, 40, 42, and 44 can take various forms, but are shown in this case as bottles that are inverted and suspended above the pumps. The fluid supply sources can also take the form of bags or other types of containers. The patient care system 20 and the fluid supply sources 38, 40, 42, and 44 are both mounted on a roller stand or pole 46. The particular fluid supply sources, as well as their orientation (e.g., mounting location, mounting height, mounting type, etc.) can generate one or more interaction records. For example, an administration set’s interaction record can be generated in part by detecting a scannable code associated with the set or detecting a physical structure on the set that encodes identification information for the set prior to use.

[0043] As Figure 1A As shown in the implementation of FIG. 1, each administration set 30, 32, 34, and 36 is connected between a respective fluid supply source 38, 40, 42, and 44 and the same patient 48, so that the patient can receive fluid from all of the fluid supply sources. The administration sets can be actively identified by, for example, a clinician’s scan, or passively identified by, for example, wireless or optical detection of the administration sets.

[0044] Individual infusion pumps 22, 24, 26, and 28 are used to infuse each fluid from the fluid supply source into the patient. The infusion pump is a flow control device that acts on the corresponding tubing or fluid conduit of the fluid delivery kit to move fluid from the fluid supply source through the conduit to the patient 48. Because of the use of individual pumps, each pump can be individually set to infuse a specific medical fluid from the corresponding fluid source into the patient at a specific rate prescribed by the clinician for that fluid, according to desired pumping or operating parameters.

[0045] Typically, medical fluid delivery kits have more parts than those shown in Figure 1. Many have check valves, drip chambers, valved ports, connectors, and other devices well known to those skilled in the art. These other devices are not included in the figures for the sake of clarity of illustration.

[0046] Figure 1B It is based on various aspects of the technology in this subject matter. Figure 1A A near-side view of a portion of the exemplary patient care system shown. Figure 1B Two fluid infusion pumps mounted on either side of a programming module are shown, along with a display and control keys for each pump, wherein the programming module is capable of programming both infusion pumps. Pump 22 includes a door 50 and a handle 52 for locking the door in a closed position for operation, and for unlocking and opening the door to access the internal pumping and sensing mechanisms and load the pump's drug delivery kit. When the door 50 is open, tubing can be connected to pump 22. When the door 50 is closed, the tubing operatively engages with the pumping mechanism, upstream and downstream pressure sensors, and other pump components. In this embodiment, a display 54 (e.g., an LED display) is located in a plan view on the door and can be used to visually convey various information related to pump 22, such as alarm indications (e.g., alarm messages). Control keys 56 are used to program and control the operation of the infusion pumps as needed. In some embodiments, the control keys may be omitted and presented as an interactive element on display 54 (e.g., a touchscreen display). Infusion pump 24 also includes an audio alarm device in the form of a speaker (not shown).

[0047] exist Figure 1A In the illustrated embodiment, the programming module 60 is attached to the left side of the infusion pump 24. For example... Figure 1AAs shown, other devices or modules including another infusion pump can be attached to the right side of the infusion pump 24 or the left side of the programming module 60. In such a system, each attached pump represents a pump channel of the overall patient care system 20. In one embodiment, the programming module is used to provide an interface between the infusion pump 24 and external devices, and provides most of the operator interface for the infusion pump 24. It should be noted that U.S. Pat. No. 5,713,856 to Eggers et al., entitled "Modular Patient Care System," incorporated herein by reference, describes a programming module as a high-level interface unit.

[0048] Returning to Figure 1B , the programming module 60 includes a display 62 for visually communicating various information, such as operating parameters of the pump 24 as well as alarm indications and alarm messages. The programming module 60 can also include a speaker to provide audible alarms. In some embodiments, the display 62 can be implemented as a touch screen display. In such embodiments, the control keys 64 can be omitted or reduced in number by providing corresponding interactive elements through a graphical user interface presented via the display 62. The programming module 60 can include a communication system (not shown) by which the programming module 60 can communicate with external devices, such as a medical facility server or other computer, and with portable processors, such as a hand-held communication device or a notebook computer, or other information devices that a clinician can have to transmit information and download drug libraries to the programming module 60 or pump. The communication module can be used to communicate access and interaction information for a clinician accessing or interfacing with a device coupled to the programming module, e.g., the pump 22 or a bar code scanner. The communication system can include one or more radio frequency (RF) systems, optical systems such as infrared, BLUETOOTH TM systems, or other wired or wireless systems. The bar code scanner and communication system can alternatively be integrated with the infusion pump 24, such as in embodiments that do not use a programming module, or in addition to the programming module 60. Thus, the information input devices need not be hard-wired to the medical appliance, and information can also be transmitted through a wireless connection.

[0049] Figure 1B The illustrated embodiment includes a second pump module 26 connected to the programming module 60. As Figure 1A shown, more pump modules can be connected. In addition, other types of modules can be connected to the pump modules or the programming module, such as an injection pump module, as Figure 2 shown, a patient-controlled analgesia module, an end-tidal CO2monitoring module, an oximeter monitoring module, and the like.

[0050] In some implementations, pressure measurements from the upstream pressure sensor and / or the downstream pressure sensor are transmitted to a server or other coordinating device, and the methods disclosed herein are implemented on the server or other coordinating device. For example, more complex and computationally intensive methods, such as machine learning, can be implemented on the server (or on a PCU with greater memory and / or CPU resources). In some implementations, machine learning is used to identify blockages in pressure signals received from the pump.

[0051] Figure 1C Examples of a healthcare organization’s institutional patient care system 100 in accordance with aspects of the subject technology are described. In Figure 1C In general, patient care devices (or “medical devices” in general) 12 are connected to a hospital network 10. The term patient care device (or “PCD”) can be used interchangeably with the term patient care unit (or “PCU”), either of which can include various ancillary medical devices such as infusion pumps, vital signs monitors, medication dispensing devices (e.g., a medication cart, a tote), medication preparation devices, automated dispensing devices, modules coupled to one of the aforementioned devices (e.g., a syringe pump module configured to attach to an infusion pump), or other similar devices. Each element 12 is connected to the internal medical network 10 by a transmission channel 31. Transmission channel 31 is any wired or wireless transmission channel, such as an 802.11 wireless local area network (LAN). In some implementations, network 10 also includes computer systems located in various departments throughout the hospital. For example, Figure 1C Network 10 can optionally include computer systems associated with an admitting department, a finance department, a biomedical engineering department, a clinical laboratory, a central supply department, one or more unit station computers, and / or a medical decision support system. As described further below, network 10 can include discrete sub-networks. In the described example, network 10 includes a device network 41 through which patient care devices 12 (and other devices) communicate in accordance with normal operations.

[0052] In addition, institutional patient care system 100 can incorporate a separate information system server 130, the functions of which will be described in greater detail below. Furthermore, although information system server 130 is shown as a separate server, the functions and programming of information system server 30 can be incorporated into another computer if desired by the engineers designing the institutional information system. Institutional patient care system 100 can also include one or more device terminals 132 for connecting and communicating with information system server 130. Device terminals 132 can include personal computers, personal data assistants, mobile devices such as laptops, tablets, augmented reality devices, or smartphones configured with software for communicating with information system server 130 via network 10.

[0053] The patient care device 12 includes a system for providing patient care, such as the system described by Eggers et al., which is incorporated herein by reference. The patient care device 12 can include or incorporate pumps, physiological monitors (e.g., heart rate, blood pressure, ECG, EEG, pulse oximeter, and other patient monitors), therapy devices, and other drug delivery devices that can also be used in accordance with the teachings set forth herein. In the described example, the patient care device 12 includes a control module 14, also referred to as an interface unit 14, which is connected to one or more functional modules 116, 118, 120, 122. The interface unit 14 includes a central processing unit (CPU) 50 connected to a memory, such as random access memory (RAM) 58, and one or more interface devices, such as a user interface device 54, a coded data input device 60, a network connection 52, and an auxiliary interface 62 for communicating with additional modules or devices. Although not necessary, the interface unit 14 also includes a main non-volatile memory unit 56, such as a hard disk drive or non-volatile flash memory, for storage of software and data and one or more internal buses 64 for interconnecting the above elements.

[0054] In various implementations, the user interface device 54 is a touch screen for displaying information to the user and allowing the user to input information by touching defined areas of the screen. Additionally or alternatively, the user interface device 54 can include any device for displaying and inputting information, such as a monitor, printer, keyboard, soft keys, mouse, trackball, and / or light pen. The data input device 60 can be a bar code reader capable of scanning and interpreting data printed in bar code format. Additionally or alternatively, the data input device 60 can be any device for inputting coded data into a computer, such as a device for reading a magnetic strip, a radio frequency identification (RFID) device in which the reader 60 captures digitally encoded data in an RFID tag or smart tag (defined below) via radio waves, a PCMCIA smart card, a radio frequency card, a memory stick, CDs, DVDs, or any other analog or digital storage media. Other examples of data input devices 60 include voice activation or recognition devices or portable personal data assistants (PDAs). Depending on the type of interface device used, the user interface device 54 and the data input device 60 can be the same device. Although the data input device 60 is shown as a separate element from the user interface device 54, the data input device 60 can be incorporated into the user interface device 54. Figure 1CWhile shown as being located within interface unit 14, it should be understood that data input device 60 may be integrated within pharmacy system 34 or located externally, communicating with pharmacy system 34 via an RS-232 serial interface or any other suitable communication means. Auxiliary interface 62 may be an RS-232 communication interface; however, without departing from the subject matter, any other means for communicating with peripheral devices (such as printers, patient monitors, infusion pumps, or other medical devices) may be used. Furthermore, data input device 60 may be a standalone functional module, such as modules 116, 118, 120, and 122, and configured to communicate with controller 14 or any other system on the network using suitable programming and communication protocols.

[0055] Network connection 52 can be a wired or wireless connection, such as via Ethernet, WiFi, Bluetooth, Integrated Services Digital Network (ISDN) connection, Digital Subscriber Line (DSL) modem, or cable modem. Any direct or indirect network connection can be used, including but not limited to telephone modems, MIB systems, RS232 interfaces, auxiliary interfaces, optical links, infrared links, radio frequency links, microwave links, or WLAN connections or other wireless connections.

[0056] Functional modules 116, 118, 120, and 122 are any devices used to provide care to patients or to monitor patient conditions. For example... Figure 1C As shown, at least one of functional modules 116, 118, 120, and 122 can be an infusion pump module, such as an intravenous infusion pump for delivering medications or other fluids to a patient. For the purposes of discussion, functional module 116 is an infusion pump module. Each of functional modules 118, 120, and 122 can be any patient treatment or monitoring device, including but not limited to infusion pumps, syringe pumps, PCA pumps, epidural pumps, enteral pumps, blood pressure monitors, pulse oximeters, EKG monitors, electroencephalogram monitors, heart rate monitors, intracranial pressure monitors, etc. Functional modules 118, 120, and / or 122 can be printers, scanners, barcode readers, near-field communication readers, RFID readers, or any other peripheral input, output, or input / output device.

[0057] Each functional module 116, 118, 120, and 122 communicates directly or indirectly with the interface unit 14, which provides comprehensive monitoring and control of the device 12. Functional modules 116, 118, 120, and 122 can be physically and electronically connected to one or both ends of the interface unit 14 in a serial manner, such as... Figure 1CAs shown, or as described by Eggers et al. It should be recognized, however, that other ways of connecting the functional modules and interface units can be used without departing from the subject technology. It should also be understood that devices that provide sufficient programmability and connectivity, such as a pump or a patient monitoring device, can operate as standalone devices and can communicate directly with the network without connecting through a separate interface unit or control unit 14. As noted above, additional medical devices or peripheral devices can be connected to the patient care device 12 through one or more auxiliary interfaces 62.

[0058] Each functional module 116, 118, 120, 122 can include module-specific components 76, a microprocessor 70, volatile memory 72, and non-volatile memory 74 for storing information. It should be noted that although Figure 1C Although four functional modules are shown in FIG. 1, any number of devices can be connected directly or indirectly to the central controller 14. The number and type of functional modules described herein are illustrative and do not limit the scope of the subject technology in any way. The module-specific components 76 include any components necessary for the operation of the specified module, such as a pumping mechanism for the infusion pump module 116.

[0059] Although each functional module is capable of at least some degree of independent operation, the interface unit 14 monitors and controls the overall operation of the device 12. For example, as will be described in greater detail below, the interface unit 14 provides programming instructions to the functional modules 116, 118, 120, 122 and monitors the status of each module.

[0060] The patient care device 12 is capable of operating in a number of different modes or personalities, each defined by a configuration database. The configuration database can be a database 56 internal to the patient care device or an external database 37. The specified configuration database is selected based at least in part on patient-specific information, such as patient location, age, physical characteristics, or medical characteristics. Medical characteristics include, but are not limited to, patient diagnosis, treatment prescription, medical history, medical record, patient care provider information, physiological characteristics, or psychological characteristics. As used herein, patient-specific information also includes care provider information (e.g., physician information) or the location of the patient care device 10 in a hospital or hospital computer network. Patient care information can be entered through the interface devices 52, 54, 60, or 62 and can come from anywhere in the network 10, for example from a pharmacy server, an admissions server, a laboratory server, etc.

[0061] Medical devices incorporating aspects of the subject technology can be equipped with a network interface module (NIM) allowing the medical device to participate as a node in a network. Although the subject technology will be described for clarity in an Ethernet network environment using Internet Protocol (IP), it should be understood that the concepts of the subject technology are equally applicable to other network environments and that such environments are intended to be within the scope of the subject technology.

[0062] Data between the various data sources can be converted to network-compatible data by existing technology, and information movement between the medical devices and the network can be accomplished in various ways. For example, the patient care devices 12 and the network 10 can communicate via automatic interaction, manual interaction, or a combination of automatic and manual interaction. Automatic interaction can be continuous or intermittent and can occur through a direct network connection 54 (as shown) or through an RS232 link, an MIB system, an RF link such as Bluetooth, an IR link, a WLAN, a digital cable system, a telephone modem, or other wired or wireless communication means. For example, manual interaction between the patient care devices 12 and the network 10 includes physically transferring data between the systems intermittently or periodically using a user interface device 54, a coded data input device 60, a bar code, a computer diskette, a portable data assistant, a memory card, or any other medium for storing data. In various aspects, the communication means is bidirectional, enabling access to data from as many distributed data source points as possible. Decisions can be made in multiple places within the network 10. For example, decisions can be made in the health information system (HIS) server 30, the decision support 48, the remote data server 49, a hospital department or unit station 46, or in the patient care devices 12 themselves, among others. Figure 1C

[0063] According to the subject technology, all direct communication with medical devices operating on the network can be performed through an information system server 30 referred to as a remote data server (RDS). According to aspects of the subject technology, a network interface module incorporated into a medical device, such as an infusion pump or a vital signs measurement device, for example, ignores all network traffic not originating from an authenticated RDS. The primary responsibility of the RDS of the subject technology is to keep track of the location and status of all networked medical devices with NIMs and to maintain open communication.

[0064] Figure 2 ​An exemplary infusion device of an infusion pump 200 according to various aspects of the subject matter is illustrated. The infusion pump 200 has a drive head including a plunger holder 202 and a finger-like clamping release member 204. When pressed, the finger-like clamping release member 204 causes the fingers of the plunger holder 202 to disengage to receive a syringe plunger. A syringe 206 holds medical fluid to be infused by the infusion pump 200. The syringe 206 is secured by a syringe clamp 208. To deliver the medical fluid, the infusion pump 200 moves the drive head to press the plunger of the syringe 206. This rate is controlled by the infusion pump 200 based on programmed parameters (e.g., desired rate) and the type of syringe.

[0065] The infusion pump typically does not experience any upstream obstruction because the fluid to be infused is contained in syringe 206 and pushed into the drug delivery kit 210 via plunger 202. According to the method described herein, downstream obstruction can be detected by a force sensor housed in or on the pump system 212, a method readily applicable to the infusion pump. The force sensor measures the force applied to the syringe plunger 202 by the drive head 204 of the infusion pump.

[0066] In some embodiments, the infusion pump may include a high-resolution pressure sensor that engages with a pressure disc (not shown) on the syringe delivery kit. The pressure disc provides a relatively large contact area with the pressure sensor. This allows the pressure sensor to measure the pressure inside the delivery kit more directly (without passing through the syringe plunger head) and provides higher resolution and accuracy compared to a drive head force sensor. Measurements from this pressure sensor and the drive head force sensor may be used independently or in combination to detect blockages in the infusion pump.

[0067] In some implementations, the syringe pump includes a retraction function that provides pressure relief, allowing the syringe to reduce the volume of the bolus after the blockage is released.

[0068] In an infusion pump, various components located in the infusion path, such as the dosing kit, cannula, filters, and valves, possess both resistance and flexibility. During normal operation, when there is no obstruction, the pump generates pressure (called the operating pressure) to overcome the resistance of these and other components in the infusion path. The operating pressure depends on the flow rate of the fluid in the infusion path. Specifically:

[0069] Working pressure = resistance × flow velocity (1)

[0070] Figure 3AAn exemplary jet pressure profile of an infusion path as a function of time, and how some methods detect downstream occlusion conditions, is shown in accordance with various aspects of the subject technology. Working pressure 310 is the typical jet pressure in the infusion path under normal operation of the infusion pump. When an occlusion occurs, at time 302, the jet pressure (P) in the infusion path rises along slope 304 until the jet pressure reaches a set occlusion threshold 306 (P alarm ) and the pump sounds an occlusion alarm. Typically, the rate of pressure increase depends on the flow rate and compliance of the administration set, pump, or syringe in the syringe pump and other components in the infusion path. Compliance is the inverse of stiffness (which is a measure of the resistance of an elastomer to deformation), and can be measured in units of meters per Newton.

[0071]

[0072] Alarm time (TTA) 308 is the time from the start of the occlusion at time 302 until the infusion path reaches the set occlusion threshold 306, P alarm . TTA 308 depends on the set occlusion threshold 306, P alarm , and the compliance of the administration set, pump, or syringe in the syringe pump and other components in the infusion path.

[0073]

[0074] According to equation (3), TTA 308 increases at lower flow rates and / or larger compliance values.

[0075] Figure 3B An exemplary jet pressure profile of an infusion path as a function of time, and how some methods detect upstream occlusion conditions, is shown in accordance with various aspects of the subject technology. Working pressure 330 is the typical upstream jet pressure in the infusion path under normal operation of the infusion pump. When an occlusion occurs, at time 322, the jet pressure (P) in the infusion path decreases along slope 324 until the jet pressure reaches a set upstream occlusion threshold 326 (P alarm ) and the pump sounds an occlusion alarm. As with the downstream jet pressure, the rate of pressure decrease depends on the flow rate and compliance of the administration set, pump, or syringe in the syringe pump and other components in the infusion path. As Figure 3B shown, for the upstream jet pressure, the pressure slope is negative. In contrast, as Figure 3A shown, for the downstream jet pressure, the pressure slope is positive. TTA 328 is the time from the start of the upstream occlusion until the jet pressure falls to the set upstream occlusion threshold 326.

[0076] Figure 4-7 The methods and systems described in the middle detect occlusion conditions in infusion devices earlier (e.g., much earlier) than methods operating according to Figure 3A and Figure 3B As shown in Figure 3A and Figure 3B , the measured dynamic pressure (or force) behaves differently under an occlusion condition (after time 302 in Figure 3A and after time 322 in Figure 3B ) compared to a normal infusion condition (before time 302 and 322, respectively, in Figure 3A and Figure 3B ). Although Figure 4 and FIG. 5 focus on detection of downstream occlusions, the disclosed methods are also applicable to upstream occlusion detection without any general loss.

[0077] In normal operation (e.g., when there is no occlusion), the pressure measured along the infusion path varies directly with flow rate according to equation (1). When the pump is varied between two different flow rates (e.g., Fl and F2), the corresponding measured pressure (or force) also varies between two different values (e.g., Pl and P2).

[0078] As shown in Figure 4 , according to various aspects of the subject technology, if the flow rate is varied from Fl to F2 and back to Fl, the measured pressure will vary from Pl to P2 and then back to Pl as shown in Figure 5A . Figure 4 A pump flow rate profile 400 is shown. In the pump flow rate profile 400, during a first time interval Tl, the pump flow rate is set to Fl (or 0 mh / hour). During a second time interval T2, the pump flow rate is set to F2, and during a third time interval T3, the pump flow rate is again set to Fl.

[0079] Generally, the pump can be set to a third flow rate F3 during the third time interval T3. In some implementations, the third flow rate F3 is equal to the first flow rate Fl. In some implementations, the first flow rate Fl (and the third flow rate F3) is 0 mh / hour. The pump flow rate profile 400 is shown with the set flow rates F set running.

[0080] The value of the fluidic pressure remains approximately constant (e.g., flat) within each of these intervals: the Pl value is approximately constant within the first time interval Tl when the system is running at the first flow rate (Fl), and the P2 value is approximately constant within the second time interval T2 when the system is running at the second flow rate (F2).

[0081] When an occlusion condition exists, the measured pressure (or force) signal can behave differently. For a given flow rate, when an occlusion condition exists downstream, the fluidic pressure does not remain constant, but rather gradually increases. The amount of pressure increase (AP) over a certain time interval is directly proportional to the amount of fluid volume injected (AV) over that time interval, i.e.,

[0082]

[0083] where AV = flow rate x time interval of infusion

[0084] The methods and systems disclosed herein include monitoring the pressure (or force) while changing the flow rate over a short period of time. In some embodiments, the method includes the following steps:

[0085] First, during a first time interval T1, the infusion device (e.g., an infusion pump) changes the flow rate from a programmed (set) rate F Set to F1. F1 is 0 ml / h, or a rate much smaller than F Set .

[0086] Second, the infusion device subsequently changes the flow rate from F1 to F2 during a second time interval T2. F2 is a flow rate much larger than F Set . T2 is between tens of milliseconds to one second. The values of F2 and T2 are selected such that the volume injected over T2 (AV = F2 x T2) is at least a few microliters.

[0087] Third, the infusion device subsequently changes the flow rate from F2 to F3 (e.g., F3 = F1) over a third time interval T3. In some embodiments, the values of F1, F2, T1, T2, and T3 are selected such that:

[0088] (T1+T2+T3) x F set = [(T1+T3) x F1 + (T2 x F2)] (5)

[0089] For the case where F1 = 0 mh / h, equation (5) becomes:

[0090] (T1+T2+T3) x F set = T2 x F2 (6)

[0091] Fourth, at the end of T3, the infusion device returns to the flow rate of F Set and continues normal infusion.

[0092] For the case where F1 = 0 mh / h, the flow rate profile described in the above four steps is shown in FIG. 4. Figure 4 Figure 5A FIG. 3 shows a flow rate profile when an occlusion condition is present, according to various aspects of the subject technology. Figure 4 ​The dashed curve 502 of the corresponding downstream jet pressure (or force) profile in the infusion path shown in the flow rate profile 400 during normal infusion in the absence of a downstream occlusion condition. The pressure value 504 before (e.g., P before ) and the pressure value 506 after (e.g., P after ) time interval T2. In the absence of an occlusion, the pressure change between time intervals T1 and T2 (e.g., ΔP = P2 - P before ) is given by:

[0093] (P2 - P before ) = flow rate x resistance (7)

[0094] where the resistance refers to the resistance introduced by the administration set, the cannula, the subject’s vein, the valve, and other components along the infusion path.

[0095] In some embodiments, the flow rate F1 and / or F3 can be set to a negative value. For example, when the flow rate has a negative value, the infusion pump moves fluid in the opposite direction for a period (e.g., a shorter) of time (e.g., during T1 and / or T3). The slope of the rise in jet pressure during T2 depends on the flow rate F2 (during T2), which is independent of F1. Based on equation 5, F2 can be higher and the slope during T2 can also be larger for negative F1.

[0096] In Figure 5A , the curve 508 shows the downstream jet pressure (or force) profile in the infusion path under a downstream occlusion condition. The pressure flow profile during T1 (pressure 510) and T3 (pressure 512) is flat because there is no flow during these time intervals. F1 = 0 mh / hour in the flow rate profile 400 shown. Figure 4 Due to the large flow rate F2, the pressure 514 rises rapidly during T2. The pressure 512 after (e.g., P after ) time interval T2 is greater than the pressure 510 before (e.g., P before ) time interval T2. The change in pressure ΔP is directly proportional to the volume pumped (F2 x T2) during the time interval T2. That is,

[0097]

[0098] The pressure change ΔP is controlled by adjusting F2 and T2, where F2 x T2 = ΔV, the volume infused during the time interval T2. ΔV is typically a few microliters.

[0099] Figure 5AThe pressure curves 502 and 508 shown in the middle are for demonstration purposes and are not drawn to scale. The smaller drop in pressure in curve 508 at the start of T1 and the start of T3 is due to the lower flow rate (F1) during T1 and T3 (e.g., F1 < F2 or F Set ). The lower flow rate means that less pressure is needed to overcome the resistance in the infusion path.

[0100] Both the syringe pump and the LVP pump exhibit downstream pressure profiles similar to curves 502 and 508.

[0101] Figure 4 The pump flow rate profile curve 400 shown includes a time period T1 in which the flow is paused (flow rate F1 is 0 mh / hour during time period T1), followed by a time period T2 which includes a pulse of fluid flow (flow rate F2 > 0 mh / hour during time period T2), followed by a second pause time period T3 (flow rate F1 is 0 mh / hour during second pause time period T3). In some embodiments, the pulse helps maintain continuity of the volume of fluid delivered while allowing for assessment of the pressure differential. In some embodiments, as shown, an alternative pump flow rate profile curve omits the pulse. Figure 5B

[0102] Figure 5B A downstream pump pressure (or force) profile curve is described for another flow rate profile curve. Curve 520, which includes a flat portion with substantially constant pressure 524, shows a downstream jet pressure (or force) profile curve in the infusion path under a downstream occlusion condition. The pressure profile curve during T1 (across pressure range 522) and T3 (across pressure range 526) is elevated due to the non-zero flow rate in the alternative pump flow rate profile curve. Due to the presence of the downstream occlusion condition, the pressure range 526 after time interval T2 is greater than the pressure range 522 before time interval T2. The first pressure measurement (P a ) is taken at T before . The second pressure measurement (P after ) is taken at T b . The two measurements are compared and a pressure differential is determined. In response to determining that the difference between the two measurements is less than a threshold value (e.g., the difference between the two measurements is small or there is no difference), the system will signal that an occlusion is detected, and an alarm is sounded or displayed. In response to detecting that the difference between the two measurements (e.g., is greater than the threshold value), the system will determine that there is no occlusion, and the pump resumes pumping fluid.

[0103] Figure 5B ​A dashed curve 530 showing the corresponding downstream jet pressure (or force) profile in the infusion path when subjected to an alternative pump flow rate profile curve during normal infusion in the absence of a downstream occlusion condition is shown in accordance with various aspects of the subject technology. The pressure change ΔΡ between Ρ a at T before and Ρ b at T after is much greater compared to the pressure change ΔΡ in the absence of an occlusion. When the pressure change ΔΡ reaches or is less than a threshold (e.g., ΔΡ ~ 0), an occlusion can occur. By omitting a pump flow rate profile curve that includes a pulse of fluid flow (e.g., pump flow rate profile curve 400 with flow rate F2 during T2), the system can obtain an occlusion detection signal faster than when using a pulsed mode. The occlusion detection mode with pump flow rate profile curves that include a pulse of fluid flow after a period of flow pause is referred to as "pulsed." The occlusion detection mode with pump flow rate profile curves that omit a pulse of fluid flow after a period of flow pause is referred to as "non-pulsed." A trade-off between these two occlusion detection modes can include, for example, better fluid continuity for the "pulsed" occlusion detection mode and faster detection speed for the "non-pulsed" occlusion detection mode.

[0104] In some implementations, both occlusion detection modes ("pulsed" and "non-pulsed") can be dynamically selected. For example, certain medications or care areas (such as a neonatal intensive care unit) can have critical delivery characteristics, and therefore continuity is an important safety factor. For these medications or care areas, the system can use the "pulsed" mode to ensure continuity of fluid. For other medications or care areas, the system can use the "non-pulsed" mode. An indication of which occlusion detection mode to use can be included in a medication library entry for a medication or care area configuration for an infusion system. Once a care area or medication is programmed into a pump, the appropriate occlusion algorithm (e.g., including the recommended occlusion detection mode) can be activated.

[0105] Figure 6 Upstream jet pressure curves 602 and 604 in accordance with various aspects of the subject technology are shown. These curves are for illustration purposes and are not drawn to scale. The upstream jet pressure curve 602 is recorded in the case of normal operation of the infusion device (e.g., no occlusion occurs). In contrast, the upstream jet pressure curve 604 is recorded when an upstream occlusion condition exists. In some implementations, the LVP pump exhibits similar upstream pressure profile curves as curves 602 and 604, respectively, in the normal and occlusion conditions. Generally, when an upstream occlusion condition occurs, a relative negative pressure (e.g., vacuum) is generated in the jet path between the point of upstream occlusion and the pump (or upstream pressure sensor).

[0106] The jet pressure curve 602 shows that the pressure 606 before the time interval T2 (P before ) is the same as the pressure 608 after this time interval (P after ).

[0107] The upstream pressure distribution curve under the upstream blockage condition is shown as the jet pressure curve 604. In some embodiments, the flow rates during the first time interval T1 and the third time interval T3 are both zero (i.e., F1 = 0 mh / hour, and F1 = 0 mh / hour). In such conditions, the pressure distribution curves (e.g., 612 and 616) during T1 and T3 are flat. Due to the relatively large flow rate F2 (e.g., as shown in Figure 4 ), the pressure drops rapidly during T2. In some embodiments, the dropping pressure begins to approach the vacuum condition in the jet channel. Therefore, the pressure (P after ) after the time interval T2 is lower than the pressure (P before ) before the time interval T2. The change in pressure ΔP is proportional to the volume (F2 × T2) pumped within the time interval T2. That is,

[0108]

[0109] the pressure change ΔP is controlled by adjusting F2 and T2, where the product of F2 and T2 reflects the volume of fluid ΔV injected during the time interval T2 (i.e., F2 × T2 = ΔV). ΔV is typically a few microliters.

[0110] Figure 6 The small increase in pressure at the start of T1 and T3 in Set is due to the relatively low flow rate (F1) during the time intervals T1 and T3 (e.g., F1 < F2 or F Set ). The relatively low flow rate means that a smaller negative pressure is required to draw fluid from the upstream of the pump. Therefore, at the start of T1 and T3, the pressure increases slightly.

[0111] In some embodiments, the downstream fluid flow rate and / or the upstream P<00000​​​​​​​​​​before ) is greater than a set upstream threshold (e.g., threshold upstream ). In some embodiments, machine learning is implemented on a server (or on a PCU with greater memory and / or CPU resources) and is used to identify blockages in pressure signals received from the pump. For example, machine learning techniques are used to adaptively adjust the threshold (e.g., between P before and P after ). In this way, the methods and systems described herein intelligently adjust the threshold, rather than using a fixed value for all pumps. In some embodiments, the machine learning includes training a model for determining whether a blockage is present using a training data set of threshold values associated with known blockage conditions.

[0113] For downstream jet pressure, a downstream blockage condition is present if ΔΡ (e.g., P after - P before ) is greater than a threshold downstream . For upstream jet pressure, an upstream blockage condition is present if ΔΡ is less than a threshold upstream . Equivalently, for upstream jet pressure, an upstream blockage condition is present if the absolute value of the pressure difference |ΔΡ| is greater than the absolute value of a threshold upstream (e.g., |threshold upstream |). Typically, threshold downstream is a positive value, and threshold upstream is a negative value. But the absolute value / magnitude of the upstream threshold |threshold upstream | is positive.

[0114] In some embodiments, to obtain a confidence in the measured pressure features recorded in the infusion path, the flow rate profile curve 400 is repeatedly generated for multiple measurements taken before and after a time interval T2 (e.g., as shown in FIG. 5 or Figure 6 In some embodiments, these measurements record upstream pressure features. In some embodiments, these measurements record downstream pressure features. In some embodiments, these measurements record both upstream and downstream pressure features (e.g., simultaneously). In some embodiments, the ΔΡ values in equations (8) and (9) are averages of multiple measurements.

[0115] In some embodiments, the pump activates the appropriate flow rate profile curve, such as Figure 4The illustrated flow rate profile 400 is generated by the pump to produce the above-described downstream pressure signature and upstream pressure signature. In some embodiments, the trigger for the pump to generate the flow rate profile is the detection of an upward slope in the downstream jet pressure or the detection of a downward slope in the upstream pressure. In some embodiments, the pump periodically (e.g., every few minutes) generates the flow rate profile (e.g., flow rate profile 400). In some embodiments, the pump takes about a second to generate the flow rate profile 400 in the infusion path. In some embodiments, the pump uses the slope change as a trigger and also periodically generates the flow rate profile 400.

[0116] Figure 7 A flowchart of a method 700 in accordance with various aspects of the subject technology is shown. The method 700 can be performed or coordinated by one or more coordinating devices, such as an infusion pump, an infusion pump module, a patient care unit (PCU) associated with an infusion pump that delivers a fluid, a server, an infusion pump controller, etc.

[0117] At step 702, the coordinating device begins to infuse fluid at a programmed flow rate F set The fluid is infused. At a subsequent step 704, the coordinating device monitors a downstream pressure value and an upstream pressure value. In some embodiments, the downstream pressure value is measured using a downstream pressure sensor. In some embodiments, the upstream pressure value is measured using an upstream pressure sensor. The methods described herein are applicable to all LVPs, regardless of their pressure sensor configuration. For example, most LVP pumps have two pressure sensors, one to sense the upstream pressure and the other to sense the downstream pressure. Some pumps do not have an upstream sensor and only have a downstream pressure sensor.

[0118] The methods described herein are also applicable to LVP pumps that have only one pressure sensor that measures both the downstream pressure and the upstream pressure (just not at the same time). For example, the flow rate profile during the downstream and upstream measurements is applied separately. At step 706, one counter (e.g., counter us ) is set to zero and another counter (e.g., counter ds ) is set to zero for upstream occlusion conditions.

[0119] At a later step 708, the coordinating device applies a flow rate profile similar to the one shown in Figure 4 over a first time interval (e.g., T1), a second time interval (e.g., T2), and a third time interval (e.g., T3). The flow rate profile includes a flow rate that is much greater than the programmed flow rate F setthe second flow rate F2 (e.g., at the second time interval). Moreover, at the programmed flow rate, the total volume of fluid flow over the sum of the first time interval, the second time interval, and the third time interval is the same as the total volume of fluid flow under the flow rate profile (for the first flow rate Fl, the second flow rate F2, and the third flow rate F3). For example, when the first flow rate is equal to the third flow rate, the following equation holds: (T1+T2+T3) x F set = [(T1+T3) x Fl] + (T2 x F2). More generally, the following equation holds: (T1+T2+T3) x F set = (T1 x Fl) + (T2 x F2) + (T3 x F3).

[0120] In some embodiments, the flow profile applied at step 708 is applied periodically during the infusion (e.g., throughout the infusion). In some embodiments, the infusion device applies the flow profile at step 708 when the time variation of the jet pressure (e.g., the slope of the jet pressure or “pressure slope”) varies faster than a certain threshold. In other words, at step 708, the pressure slope triggers the application of the flow profile. The jet pressure can be the downstream jet pressure or the upstream jet pressure.

[0121] At step 710, the coordination device measures the downstream pressure values and the upstream pressure values before and after the time interval with the high flow rate (e.g., when the flow rate is F2, Figure 4 the second time interval T2) respectively, resulting in P before and P after .

[0122] The coordination device processes the measured downstream jet pressure and the upstream jet pressure respectively.

[0123] Downstream jet pressure

[0124] At step 712a, the coordination device calculates the downstream jet pressure difference (or pressure difference) AP between P before and P after . In some embodiments, the calculation of the pressure difference AP is performed by subtracting P after from P before (i.e., P after - P before ). As Figure 5A shown, when the downstream occlusion condition is present, P after is greater than P before , resulting in a positive pressure difference AP.

[0125] When the pressure difference AP is greater than a set threshold of the downstream jet pressure (threshold downstreamthe counter for the downstream occlusion condition is incremented. Subsequently, the coordinating device checks whether the value of the counter for the downstream occlusion condition is greater than a set value. In some embodiments, the set value is 3, indicating the number of measurements of the downstream occlusion condition before an alarm goes off. If the value of the counter for the downstream occlusion condition is less than the set number, the coordinating device again applies the flow profile curve shown in FIG. 7B, and repeats steps 710 and 712a. Conversely, if the value of the counter for the downstream occlusion condition is greater than the set value, the infusion process is stopped, and the coordinating device issues a downstream occlusion alarm. Figure 4

[0126] When the pressure difference ΔΡ is less than a threshold value downstream , the infusion device continues to infuse at the programmed flow rate F set , and returns to step 704.

[0127] Upstream jet pressure

[0128] In step 712b, the coordinating device calculates the upstream jet pressure difference (or pressure differential) ΔΡ between P before and P after . In some embodiments, the calculation of the pressure differential ΔΡ is made by subtracting P before from P after (i.e., P after - P before ). As shown in FIG. 7B, when an upstream occlusion condition exists, P after is less than P before , resulting in a negative pressure differential ΔΡ. Figure 6

[0129] When this pressure difference ΔΡ is less than (i.e., more negative) a set threshold value (threshold value upstream ) for the upstream jet pressure, the counter for the upstream occlusion condition is incremented.

[0130] In some embodiments, the magnitude of the pressure differential is taken, and the absolute value of ΔΡ is compared to the threshold value upstream . In this case, when |ΔΡ| is greater than the threshold value upstream , the counter for the upstream occlusion condition is incremented. Subsequently, the coordinating device checks whether the value of the counter for the upstream occlusion condition is greater than a set value. In some embodiments, this set value is the same as the set value for the downstream occlusion condition. Alternatively, a different value is set if the tolerance for the upstream occlusion condition is different from the tolerance for the downstream occlusion condition. In some embodiments, the set value is 3, indicating the number of measurements of the upstream occlusion condition before an alarm goes off. If the value of the counter for the upstream occlusion condition is less than the set number, the coordinating device again applies the flow profile curve shown in FIG. 7B, and repeats steps 710 and 712a. Conversely, if the value of the counter for the upstream occlusion condition is greater than the set value, the infusion process is stopped, and the coordinating device issues an upstream occlusion alarm. Figure 4 ​​The flow distribution curve shown is used, and steps 710 and 712B are repeated. Conversely, if the value of the counter used for upstream blockage is greater than the set value, the infusion process stops, and the coordinating device issues an upstream blockage alarm.

[0131] When the pressure difference ΔP is less than the threshold downstream At this point, the infusion device continues to infuse at the programmed flow rate Fset and returns to step 704.

[0132] In some implementations, for example, such as Figure 8-12 As shown, in F set Infusion devices operating in pulse mode have been manufactured. Figure 4 The flow distribution curve is shown without needing to generate separate sequences of flow velocities F1, F2, and F3. In this case, step 708 is optional.

[0133] Figure 8-12 Examples of implementing the methods described in this disclosure according to various aspects of the subject matter are provided. These examples utilize existing velocity profiles generated by LVP pumps. At flow rates below 40 mH / h, the velocity profile generated by an LVP pump is similar to... Figure 2 The velocity distribution curves shown allow for convenient demonstration of the feasibility of the methods described in this disclosure.

[0134] When the flow rate is below 40 mH / h, the LVP pump operates in pulse mode. For example, in some implementations, each pulse causes the stepper motor to move 25 steps. For a motor operating at 1 kHz, these 25 steps are completed within 25 milliseconds. In some cases, there are 200 pulses in one mechanism cycle.

[0135] Figure 8 Two consecutive flow pulses 802 and 806, with a flow rate of 1 mH / h, are shown according to various aspects of the subject matter. Each flow pulse and its ripple lasts approximately 200 milliseconds. The volume injected in each pulse is approximately 1-2 μL. The two flow pulses have peaks separated by a time interval 806. The time between pulses depends on the flow rate. For example, at a programmed flow rate of 1 mH / h, this time is approximately 3.25 seconds. The flow rate between pulses 802 and 804 is 0 mH / h. Therefore, each flow pulse (e.g., flow pulse 802 and flow pulse 804) is similar to... Figure 4 The high flow rate shown is (e.g., T2). Figure 8 The example shown uses a flow rate distribution curve to measure the pressure before and after each pulse in order to distinguish normal operation of the infusion pump (e.g., no blockage) from downstream or upstream blockage conditions.

[0136] Figure 9 and Figure 10Bare shown for a system operating under the flow rate profile shown in Figure 9 ) and a downstream occlusion condition Figure 10B ) in accordance with various aspects of the subject technology. Figure 8 The corresponding measured downstream pump pressure profile for the flow rate profile shown in Figure 9 . In this example, a first measured pressure peak 902 corresponds to the flow pulse 802 shown in Figure 8 , and a second measured pressure peak 904 corresponds to the flow pulse 804 shown in Figure 8 . The measured pressure peaks 902 and 904 are measured in volts from the voltage output of the downstream pressure sensor. The two measured pressure peaks are separated by a time interval 906. Figure 10A An expanded time scale representation of the portion 908 shown in Figure 9 .

[0137] Figure 10A and Figure 10B are presented on the same time scale to facilitate comparison of the pressure measurements under normal operation Figure 10A ) and a downstream occlusion condition Figure 10B .

[0138] Figure 11 and Figure 12 show the corresponding measured upstream pump pressure profile from an upstream pump pressure sensor for a system operating under the flow rate profile shown in Figure 8 in accordance with various aspects of the subject technology. Figure 11 The measurements recorded by the upstream pressure sensor when the system is operating normally are shown. Figure 12 The measurements recorded by the upstream pressure sensor when the system experiences an upstream occlusion are shown.

[0139] Figure 11 A first measured pressure peak 1102 corresponds to the flow pulse 802 shown in Figure 8 , and a second measured pressure peak 1104 corresponds to the flow pulse 804 shown in Figure 8 . The measured pressure peaks 1102 and 1104 are measured in volts from the voltage output of the downstream pressure sensor. The two measured pressure peaks are separated by a time interval 1106 that matches the time interval 806.

[0140] As shown in Figure 9 and Figure 10A , the value of the first (downstream) pressure 910 before the flow pulse 802 is approximately the same as the value of the second (downstream) pressure 912 after the pulse 802. In contrast, in Figure 10BUnder the downstream blockage condition shown, the value of the fourth (downstream) pressure 1006 after the flow pulse 802 is shifted upward (e.g., by approximately 10-15 mV) compared to the value of the third (downstream) pressure 1004 before the flow pulse 802.

[0141] Figure 12 The pressure measurements recorded under upstream blockage conditions are shown. The value of the second (upstream) pressure 1206 after flow pulse 802 is shifted downward (e.g., approximately 30 mV) compared to the value of the first (upstream) pressure 1204 before the flow pulse.

[0142] In some implementations, the measured pressure values ​​are averaged (e.g., using an averaging function) over a selected duration (e.g., several hundred milliseconds (ms), about 700 ms, about 600 ms, about 500 ms, about 400 ms, about 300 ms, about 200 ms, about 100 ms).

[0143] The second (downstream) pressure 912, the fourth (downstream) pressure 1006, and the second (upstream) pressure 1206 are all jet pressures P following the flow pulse. after Example. The first (downstream) pressure 910, the third (downstream) pressure 1004, and the first (upstream) pressure 1204 are the jet pressures P before the flow pulse. before Examples.

[0144] ΔP is P after and P before The difference between them (e.g., P) after -P before ), or differential pressure. Choose an appropriate threshold for ΔP to determine if the measured pressure value corresponds to a blockage condition. If the measured ΔP(P) after -P before If the threshold is exceeded, a decision can be made to issue a blocking alert.

[0145] When the measured pressure difference ΔP (i.e., P) after -P before The value is greater than the set downstream threshold (e.g., threshold). downstream When the measured pressure difference ΔP (i.e., P) is reached, downstream blockage exists. after -P before The threshold is less than the set upstream threshold (e.g., threshold). upstream When the measured pressure difference ΔP (i.e., P) is positive, an upstream blockage exists. after -P before The value of ) is greater than the set upstream threshold (e.g., threshold). upstream If ), then upstream blockage exists.

[0146] In some embodiments, a low pass filter is used to further improve the signal-to-noise ratio of pressure measurements from the upstream sensor and / or downstream sensor. In some embodiments, the low pass filter is used for signals between less than 40 Hz, such that noise from higher repetition rate sources (e.g., a pump motor running at 1 kHz or random electrical noise) will be reduced (e.g., eliminated).

[0147] In some embodiments, a band pass filter is used to further improve the signal-to-noise ratio of pressure measurements from the upstream sensor and / or downstream sensor. In some embodiments, the band pass filter is used for signals between 1 Hz and 40 Hz, such that noise from higher repetition rate sources (e.g., a pump motor running at 1 kHz or random electrical noise) will be reduced (e.g., eliminated).

[0148] Figure 13 Example methods for detecting occlusions in accordance with aspects of the subject technology are described. For purposes of explanation, various block diagrams of example method 1300 are described herein with reference to FIGS. 1-12, as well as the components and / or methods described herein. For example, one or more block diagrams of method 1300 can be implemented by one or more computing devices, such as infusion device 12. In some embodiments, one or more block diagrams can be separate from other block diagrams and implemented by one or more different processors or devices. Further, for purposes of explanation, the block diagrams of example method 1300 are described as occurring serially or linearly. However, multiple block diagrams of example method 1300 can occur in parallel. Further, the block diagrams of example method 1300 need not be performed in the order shown, and / or one or more block diagrams of example method 1300 need not be performed.

[0149] In the described example, the infusion device causes a flow of fluid within a fluidic channel of the infusion device during a first time period, during which the flow rate of the fluid is set to a first flow rate. The infusion device pauses the flow rate for a second time period after the first time period; and measures a first pressure at a location along the fluidic channel during the second time period after pausing the flow rate. After measuring the first pressure, the infusion device increases the flow rate to a second flow rate that is substantially higher than the first flow rate for a third time period; and pauses the flow rate for a fourth time period after the third time period. After pausing the flow rate, the infusion device measures a second pressure at the location during the fourth time period; and calculates a difference between the first pressure and the second pressure at the processor (1302).

[0150] The processor determines whether the difference satisfies a threshold (1304).

[0151] In response to the value satisfying the threshold, the output of the infusion device provides an indication of the presence of the occlusion (1306). The indication can be a human perceptible indication, such as via a user interface, light, sound, or haptic feedback. In addition, the infusion device can send an alert message (indicating the occlusion) to a remote receiver, such as a nursing station in a hospital, via a server. In some embodiments, the infusion device can additionally or alternatively adjust the operation of one or more physical elements included therein. For example, the infusion device can cut power to a motor driving a pump, initiate a fallback (e.g., reverse the syringe pump drive head to pull the plunger back), etc., to prevent additional pressure buildup. The display of the infusion device can additionally or alternatively be adjusted. The infusion device can adjust the operation of a second infusion device (e.g., an infusion module). For example, if two modules are pumping different fluids to a patient, if one line is occluded, the administration of the second fluid via the second infusion device can need to be adjusted (or prevented).

[0152] The example method 1300 repeats steps 1302-1306 until the infusion is complete (1308).

[0153] Figure 14 FIG. 14 is a conceptual diagram illustrating an example electronic system 1400 for automatically adjusting control of a medical device in response to detecting a hostile environment, in accordance with aspects of the subject technology. The electronic system 1400 can be a computing device for executing software associated with one or more portions or steps of the method 1400, or components and methods provided by FIGS. 1-13, including but not limited to the information system server 30, the production server 204, computing hardware within the patient care device 12, or the terminal device 37. In conjunction with the disclosure provided with respect to FIGS. 1-13, the electronic system 1400 can be representative. In this regard, the electronic system 1400 can be a personal computer or a mobile device (such as a smartphone, tablet, laptop, PDA, augmented reality device), a wearable device (such as a watch or a band or glasses or the like or combinations thereof), or other touchscreen or television with one or more processors embedded or coupled thereto, or any other type of computer-related electronic device having network connectivity.

[0154] The electronic system 1400 can include various types of computer-readable media and interfaces for various other types of computer-readable media. In the depicted example, the electronic system 1400 includes a bus 1408, processing unit(s) 1412, a system memory 1404, a read-only memory (ROM) 1410, a permanent storage device 1402, an input device interface 1414, an output device interface 1406, and one or more network interfaces 1416. In some embodiments, the electronic system 1400 can include or be integrated with other computing devices or circuitry for running the aforementioned various components and methods.

[0155] Bus 1408 collectively represents all system, peripheral and chipset buses that communicatively connect the various internal devices of the electronic system 1400. For instance, bus 408 communicatively connects the (multiple) processing unit(s) 1412 with the ROM 1410, the system memory 1404, and the persistent storage device 1402.

[0156] The (multiple) processing unit(s) 1412 retrieve instructions to execute and data to process from these various memory units, using bus 1408. The (multiple) processing unit(s) can be single-processor or multi-core processors in different implementations.

[0157] ROM 1410 stores static data and instructions that are needed by the (multiple) processing unit(s) 1412 and other modules of the electronic system. The persistent storage device 1402, on the other hand, is a read-and-write memory device. This device is a non-volatile memory unit that stores instructions and data even when the electronic system 1400 is off. Some implementations of the subject disclosure use a mass-storage device (such as a magnetic or optical disk and its corresponding disk drive) as the persistent storage device 402.

[0158] Other implementations use a removable storage device (such as a floppy disk, flash drive and its corresponding disk drive) as the persistent storage device 1402. Like the persistent storage device 1402, the system memory 1404 is a read-and-write memory device. However, unlike the persistent storage device 1402, the system memory 1404 is a volatile read-and-write memory, such as a random access memory. The system memory 1404 stores some of the instructions and data that the processor needs at runtime. In some implementations, the processes of the subject disclosure are stored in the system memory 1404, the persistent storage device 1402, and / or the ROM 1410. From these various memory units, the (multiple) processing unit(s) 1412 retrieves instructions to execute and data to process in order to execute the processes of some implementations.

[0159] Bus 1408 also connects to the input and output devices interface 1414 and 1406. The input devices interface 1414 enables a user to communicate information and select commands to the electronic system. Input devices used with the input devices interface 1414 include, for example, alphanumeric keyboards and pointing devices (also called “cursor control devices”). Output devices interface 1406 enables, for example, the display of images generated by the electronic system 1400. Output devices used with the output devices interface 1406 include, for example, printers and display devices, such as cathode ray tubes (CRT) or liquid crystal displays (LCD). Some implementations include devices that function as both input and output devices, such as a touch screen.

[0160] Furthermore, as Figure 14As shown, bus 1408 also couples electronic system 1400 to a network (not shown) via network interface 1416. Network interface 1416 may include, for example, a wireless access point (e.g., Bluetooth or WiFi) or radio communication circuitry for connecting to a wireless access point. Network interface 1416 may also include hardware (e.g., Ethernet hardware) for connecting the computer to a part of a computer network, such as a local area network (“LAN”), a wide area network (“WAN”), a wireless LAN or intranet, or a network of networks, such as the Internet. Any or all components of electronic system 1400 may be used in conjunction with this disclosure.

[0161] The above functions can be implemented in computer software, firmware, or hardware. These technologies can be implemented using one or more computer program products. Programmable processors and computers can be contained in or packaged as mobile devices. Processes and logical flows can be implemented by one or more programmable processors and one or more programmable logic circuits. General-purpose and special-purpose computing devices and storage devices can be interconnected through communication networks.

[0162] Some implementations include electronic components, such as microprocessors, storage, and memory, that store computer program instructions in a machine-readable medium or computer-readable medium (also known as a computer-readable storage medium, machine-readable medium, or machine-readable storage medium). Examples of such computer-readable media include RAM, ROM, read-only optical disc (CD-ROM), recordable optical disc (CD-R), rewritable optical disc (CD-RW), read-only digital versatile optical disc (e.g., DVD-ROM, dual-layer DVD-ROM), various recordable / rewritable DVDs (e.g., DVD-RAM, DVD-RW, DVD+RW, etc.), flash memory (e.g., SD card, mini SD card, micro SD card, etc.), magnetic and / or solid-state hard disk drives, read-only and recordable... Optical discs, high-density optical discs, any other optical or magnetic media, and floppy disks. Computer-readable media may store computer programs executable by at least one processing unit and include a set of instructions for performing various operations. Examples of computer programs or computer code include, for example, machine code generated by a compiler, and files containing high-level code executed by a computer, electronic components, or a microprocessor using an interpreter.

[0163] While the above discussion primarily concerns microprocessors or multi-core processors that execute software, some implementations utilize one or more integrated circuits, such as application-specific integrated circuits (ASICs) or field-programmable gate arrays (FPGAs). In some implementations, such integrated circuits execute instructions stored on the circuit itself.

[0164] As used in this specification and any claims of this application, the terms “computer”, “server”, “processor”, and “memory” all refer to electronic or other technological devices. These terms exclude people or groups of people. For purposes of this specification, the term display or displaying means displaying on an electronic device. As used in this specification and any claims of this application, the terms “computer readable medium” and “computer readable media” are entirely restricted to tangible, physical objects that store information in a form that is readable by a computer. These terms exclude any wireless signals, wired download signals, and any other ephemeral signals.

[0165] To provide for interaction with a user, implementations of the subject matter described in this specification can be implemented on a computer having a display device, e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor, for displaying information to the user and a keyboard and a pointing device, e.g., a mouse or a trackball, by which the user can provide input to the computer. Other kinds of devices can be used to provide for interaction with a user as well; for example, feedback provided to the user can be any form of sensory feedback, e.g., visual feedback, auditory feedback, or tactile feedback; and input from the user can be received in any form, including acoustic, speech, or tactile input. In addition, a computer can interact with a user by sending documents to and receiving documents from a device that is used by the user; for example, by sending web pages to a web browser on a user’s client device in response to requests received from the web browser.

[0166] Implementations of the subject matter described in this specification can be implemented in a computing system that includes a back-end component, e.g., as a data server, or that includes a middleware component, e.g., an application server, or that includes a front-end component, e.g., a client computer having a graphical user interface or a Web browser through which a user can interact with an implementation of the subject matter described in this specification, or any combination of one or more such back-end, middleware, or front-end components. The components of the system can be interconnected by any form or medium of digital data communication, e.g., a communication network. Examples of communication networks include a local area network (“LAN”) and a wide area network (“WAN”), an inter-network (e.g., the Internet), and peer-to-peer networks (e.g., ad hoc peer-to-peer networks).

[0167] The computing system can include clients and servers. A client and server are generally remote from each other and typically interact through a communication network. The relationship of client and server arises by virtue of computer programs running on the respective computers and having a client-server relationship to each other. In some embodiments, a server transmits data (e.g., an HTML page) to a client device (e.g., for purposes of displaying data to and receiving user input from a user interacting with the client device). Data generated at the client device (e.g., a result of the user interaction) can be received from the client device at the server.

[0168] Those skilled in the art will appreciate that the various illustrative block diagrams, modules, elements, components, methods, and algorithms described herein can be implemented as electronic hardware, computer software, or combinations of both. To illustrate the interchangeability of hardware and software, various illustrative blocks, modules, elements, components, methods, and algorithms have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application. Various components and blocks can be differentially arranged in different orientations (e.g., arranged in a different order, or arranged differently in a different manner), all of which are within the scope of the subject technology.

[0169] It should be understood that the particular order in which the steps of the disclosed processes have been presented is exemplary. It should be appreciated that unless otherwise specifically stated the particular order in which the steps of such processes have been presented can differ in other implementations. In some embodiments, some of the steps can be performed concurrently, in different orders, or omitted. The accompanying claims are presented to protect the scope of the subject technology and are not intended to limit the particular order or manner in which the various steps are performed.

[0170] Summary of the subject technology:

[0171] For convenience, a number of example embodiments of various aspects of the present disclosure are described below by numbering clauses (1, 2, 3, etc.). These are provided as examples only and do not limit the subject technology. Reference signs and identifications of the figures are shown below as examples and for illustrative purposes only, and the clauses are not limited by these identifications.

[0172] Clause 1. A method for detecting an occlusion in a fluidic channel of an infusion device, the method comprising: flowing a fluid within the fluidic channel during a first time period, during which the flow rate of the fluid is set to a first flow rate; pausing the flow rate for a second time period after the first time period; measuring a first pressure at a location along the fluidic channel during the second time period after pausing the flow rate; increasing the flow rate to a second flow rate that is substantially higher than the first flow rate for a third time period after measuring the first pressure; pausing the flow rate for a second time period after the first time period; measuring a second pressure at the location during the fourth time period after pausing the flow rate; calculating a difference between the first pressure and the second pressure at the processor; determining whether a magnitude of the difference between the first pressure and the second pressure satisfies a threshold; and providing an indication of the presence of an occlusion at an output of the infusion device in accordance with a determination that the magnitude of the difference satisfies the threshold.

[0173] Clause 2. The method of clause 1, further comprising: receiving a selection to change an occlusion detection mode; and based on the received selection: pausing the flow rate for a fifth time period after receiving the selection to change the occlusion detection mode; measuring a third pressure at a beginning portion of the fifth time period; measuring a fourth pressure at an ending portion of the fifth time period; and calculating a second difference between the third pressure and the fourth pressure at the processor; determining whether a magnitude of the second difference satisfies a second threshold; and providing an indication of the presence of an occlusion at an output of the infusion device in accordance with a determination that the magnitude of the second difference satisfies the second threshold.

[0174] Clause 3. The method of clause 2, further comprising stopping infusion of the fluid and presenting an alert indicating an occlusion condition when the magnitude of the second difference is equal to or less than the second threshold.

[0175] Clause 4. The method of clause 2, further comprising continuing infusion of the fluid when the magnitude of the second difference is greater than the second threshold.

[0176] Clause 5. The method of clause 1, wherein the fluid is infused along the fluidic channel at a preset flow rate, and the preset flow rate is driven by an infusion pump operating in a pulsed mode.

[0177] Clause 6. The method of clause 1, further comprising stopping infusion of the fluid and presenting an alert indicating a downstream occlusion condition when the first pressure is less than the second pressure and the magnitude of the difference is greater than the threshold.

[0178] Clause 7. The method of clause 1, further comprising stopping infusion of the fluid and presenting an alert indicating an upstream occlusion condition when the first pressure is greater than the second pressure and the magnitude of the difference is greater than the threshold.

[0179] Clause 8. The method of clause 1, wherein calculating the difference between the first pressure and the second pressure comprises calculating the difference from a determination of a rising slope of the fluidic pressure of the fluid in the fluidic channel detected by the downstream pressure sensor.

[0180] Clause 9. The method of clause 1, wherein calculating the difference between the first pressure and the second pressure comprises calculating the difference from a determination of a falling slope of the fluidic pressure of the fluid in the fluidic channel detected by the upstream pressure sensor.

[0181] Clause 10. The method of clause 1, wherein the product of the second flow rate and the third time period is a few microliters.

[0182] Clause 11. The method of clause 1, wherein, when the first pressure is less than the second pressure and the difference is greater than a threshold value, the occlusion comprises a downstream occlusion.

[0183] Clause 12. The method of clause 1, wherein, when the first pressure is greater than the second pressure and a magnitude of the difference is greater than a threshold value, the occlusion comprises an upstream occlusion.

[0184] Clause 13. The method of clause 1, further comprising: averaging over a first duration of a second time period to obtain the first pressure; and averaging over a second duration of a fourth time period to obtain the second pressure.

[0185] Clause 14. The method of clause 13, wherein the first duration is a few hundred milliseconds.

[0186] Clause 15. The method of clause 1, further comprising obtaining an average difference by calculating additional pressure differences at the location at different time intervals, and providing the indication of the presence of the occlusion when a magnitude of the average difference satisfies a threshold value.

[0187] Clause 16. The method of clause 1, wherein providing the indication of the presence of the occlusion comprises providing the indication at an output of the infusion device after a set number of repeated calculations and determinations.

[0188] Clause 17. The method of clause 16, wherein providing the indication of the presence of the occlusion comprises increasing a value of a counter each time a magnitude of the difference satisfies a threshold value, and providing the indication of the presence of the occlusion when the value of the counter equals the set number.

[0189] Clause 18. The method of clause 1, further comprising adjusting a duration of the third time period and a value of the second flow rate.

[0190] Clause 19. The method of clause 1, wherein the flow rate profile is formed by the first flow rate, the second flow rate, and a third flow rate, and the infusion device generates the flow rate profile to detect the occlusion.

[0191] Clause 20. The method of clause 1, wherein providing the indication at the output of the infusion device comprises sounding an alarm at the infusion device.

[0192] Clause 21. The method of clause 1, wherein providing the indication at the output of the infusion device comprises displaying a warning message on a display screen of the infusion device.

[0193] Clause 22. The method of clause 1, wherein the processor is a processor of the infusion device.

[0194] Clause 23. The method of clause 1, wherein the processor is a processor of the server with which the infusion device is in electronic communication.

[0195] Clause 24. The method of clause 1, wherein the threshold is adaptively adjusted based at least in part on a parameter of the infusion device.

[0196] Clause 25. The method of clause 24, wherein the threshold is adaptively adjusted between a first pressure and a second pressure.

[0197] Clause 26. The method of clause 1, further comprising using machine learning to determine the threshold.

[0198] Clause 27. The method of clause 26, wherein using machine learning comprises using a training data set of values of thresholds associated with known occlusion conditions.

[0199] Clause 28. A non-transitory machine-readable storage medium containing instructions that, when executed by a machine, allow the machine to perform a method of detecting an occlusion in a fluidic channel according to the method of one of clauses 1-27.

[0200] Clause 29. A system comprising: one or more processors; and a memory comprising instructions that, when executed by the one or more processors, cause the one or more processors to perform the method of one of clauses 1-27.

[0201] Clause 30. A non-transitory machine-readable storage medium containing instructions that, when executed by a machine, allow the machine to perform a method for detecting an occlusion in a fluidic channel of an infusion device, the method comprising: flowing a fluid within the fluidic channel during a first time period, during which the flow rate of the fluid is set to a first flow rate; pausing the flow rate for a second time period after the first time period; measuring a first pressure at a location along the fluidic channel during the second time period after pausing the flow rate; increasing the flow rate to a second flow rate that is substantially higher than the first flow rate for a third time period after measuring the first pressure; pausing the flow rate for a second time period after the first time period; measuring a second pressure during a fourth time period after pausing the flow rate; calculating a difference between the first pressure and the second pressure at the processor; determining whether a magnitude of the difference between the first pressure and the second pressure satisfies a threshold value; and providing an indication that an occlusion exists at an output of the infusion device in accordance with a determination that the magnitude of the difference satisfies the threshold value.

[0202] Clause 31. An infusion system comprising: an infusion device; and a processor configured to: control the infusion device to flow a fluid within a fluidic channel of the infusion jet during a first time period, during which a flow rate of the infusion jet is set to a first flow rate; control the infusion device to pause the flow rate for a second time period after the first time period, receive a measurement of a first pressure at a location along the fluidic channel during the second time period after pausing the flow rate; control the infusion device to increase the flow rate to a second flow rate that is substantially higher than the first flow rate for a third time period after measuring the first pressure; control the infusion device to pause the flow rate for a fourth time period after the third time period; receive a measurement of a second pressure at the location during the fourth time period after pausing the flow rate; calculate a difference between the first pressure and the second pressure; determine whether a magnitude of the difference between the first pressure and the second pressure satisfies a threshold value; and in accordance with a determination that the magnitude of the difference satisfies the threshold value: present an indication that an occlusion exists at an output of the infusion device.

[0203] Further considered:

[0204] In some embodiments, any of the clauses herein can rely on any of the independent clauses or any of the dependent clauses. In one aspect, any of the clauses (e.g., dependent or independent clauses) can be combined with any other one or more clauses (e.g., dependent or independent clauses). In one aspect, a claim can include some or all of the language recited in a clause, sentence, phrase, or paragraph (e.g., steps, operations, means, or elements). In one aspect, a claim can include some or all of the language recited in one or more clauses, sentences, phrases, or paragraphs. In one aspect, some of the language in each of the clauses, sentences, phrases, or paragraphs can be removed. In one aspect, additional language or elements can be added to the clauses, sentences, phrases, or paragraphs. In one aspect, the subject technology can be practiced without utilizing some of the components, elements, functions, or operations recited in the herein. In one aspect, the subject technology can be practiced with additional components, elements, functions, or operations.

[0205] The foregoing description is provided to enable any person skilled in the art to practice the various aspects described herein. The description provided above is not intended as an exhaustive description of either the various aspects or the subject technology described herein. Various modifications can be made to the aspects described, and equivalents can be substituted, without departing from the true scope of the subject technology. Thus, the claims are not intended as being limited to the aspects shown herein, but rather they are to be accorded the full scope consistent with the language claims, wherein connection to the singular form includes the plural and vice versa, unless explicitly stated otherwise. The description herein is presented for purposes of illustration and description and is not intended to limit the scope of the subject technology to the precise form described, and the scope of the subject technology is to be accorded the broadest scope consistent with the principles and novel features disclosed herein.

[0206] The predicates “configured to,” “operable to,” and “programmed to” do not imply any specific tangible or intangible modification to the subject, but rather merely that the subject is capable of performing the recited operation. For example, a processor configured to monitor and control an operation or a component can also mean a processor programmed to monitor and control the operation or a processor operable to monitor and control the operation. Likewise, a processor configured to execute code can be interpreted as a processor programmed to execute the code or a processor operable to execute the code.

[0207] The term "automatic" as used herein can include performance of a computer or machine without the need for user intervention; for example, by responding to action-based instructions of a computer or machine or other initiation mechanism. The word "example" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "example" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

[0208] The phrase "in one aspect" does not necessarily refer to the same aspect, although it can. "Aspects" or "embodiments" of the subject matter described herein can comprise one or more aspects or implementations. The disclosure herein can use "a" or "one" to describe features, implementations and / or aspects of the subject matter. This does not exclude multiple from the feature, implementation and / or aspect being performable. The disclosure herein can use "an" or "one" to describe features, implementations and / or aspects of the subject matter. This does not exclude multiple from the feature, implementation and / or aspect being performable. The disclosure herein can use "a" or "one" to describe features, implementations and / or aspects of the subject matter. This does not exclude multiple from the feature, implementation and / or aspect being performable. The phrase "in one aspect" does not necessarily refer to the same aspect, although it can. The phrase "in one embodiment" does not necessarily refer to the same embodiment, although it can. The phrase "in one configuration" does not necessarily refer to the same configuration, although it can. The phrase "in one configuration" does not necessarily refer to the same configuration, although it can. The phrase "in one configuration" does not necessarily refer to the same configuration, although it can. The phrase "in one configuration" does not necessarily refer to the same configuration, although it can.

[0209] As used herein, a "user interface" (also referred to as an interactive user interface, graphical user interface, or UI) can refer to a web-based interface that includes data fields and / or other control elements for receiving input signals or providing electronic information and / or for providing information to a user in response to any received input signals. Control elements can include dials, buttons, icons, selectable areas, or other perceptible indicia presented via the UI that, when interacted with (e.g., clicked, touched, selected, etc.), cause the device presenting the UI to initiate an exchange of data. A UI can be implemented in whole or in part using technologies such as HyperText Markup Language (HTML), FLASH TM , JAVA TM ,.NET TM , C, C++, web services, or Rich Site Summary (RSS). In some embodiments, a UI can be included in a standalone client (e.g., thin client, fat client) that is configured to communicate (e.g., send or receive data) in accordance with one or more aspects described. The communication can be to or from a medical device or server with which it is in communication.

[0210] As used herein, the term "determining" or "determine" encompasses a wide variety of actions. For example, "determining" can include calculating, computing, processing, deriving, generating, obtaining, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like via a hardware element based on at least in part information received. Also, "determining" can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like via a hardware element based on at least in part information. "Determining" can include resolving, selecting, choosing, establishing and the like via a hardware element based on at least in part information.

[0211] As used herein, the term "providing" or "provide" encompasses a wide variety of actions. For example, "providing" can include storing values in the location in a storage for subsequent retrieval, sending a value directly to a recipient via at least one wired or wireless communication medium, sending or storing a reference to the value, and the like. "Providing" can also include encoding, decoding, encrypting, decrypting, authenticating, verifying and the like via a hardware element.

[0212] As used herein, the term "message" includes a wide variety of formats for communicating (e.g., sending or receiving) information. A message can include a collection of machine-readable information such as an XML document, a fixed field message, a comma separated message, JSON, a custom protocol, and the like. In some embodiments, a message can include a signal or signals for transmitting one or more representations of information. Although recited in the singular, it is understood that a message can be composed of, sent, stored, received and the like by multiple parts.

[0213] As used herein, the term "selectively" or "selectivity" can encompass a wide variety of actions. For example, a "selective" process can include determining one option from a plurality of options. A "selective" process can include one or more of: dynamically determined input, pre-configured input, or user initiated input for making a determination. In some embodiments, an n-input switch can be included to provide selective functionality, where n is the number of inputs for making a selection.

[0214] As used herein, the term "corresponding" or "correspondence" encompasses a structural, functional, quantitative and / or qualitative association or relationship between two or more objects, data sets, information and the like, preferably wherein the correspondence or relationship can be used to interpret one or more of the two or more objects, data sets, information and the like so as to appear the same or equal. The correspondence can be evaluated using one or more of a threshold, a range of values, fuzzy logic, pattern matching, a machine learning evaluation model or combinations thereof.

[0215] In any embodiment, data generated or detected can be forwarded to a "remote" device or location, where "remote" refers to a location or device other than the location or device where the procedure is performed. For example, a remote location can be another location (e.g., office, laboratory, etc.) in the same city, another location in a different city, another location in a different state, another location in a different country, etc. Thus, when one item is indicated as being "remote" from another item, this means that the two items can be in the same space but independent, or at least in different spaces or different buildings, and can be at least one mile, ten miles, or at least one hundred miles apart. "Communicating" information refers to the transmission of data representing the information as electrical, electromagnetic or optical signals which are capable of being carried on a suitable communication channel (wire, cable, microwave, optical link, etc.). "Forwarding" an item refers to any means of moving that item from one location to the next, whether by physically transferring the item or otherwise (where possible), and in the case of data at least includes physically communicating a medium carrying the data or transmitting the data. Examples of communication media include a wireless or infrared transmission channel, and a network connection to another computer or networking device, as well as the Internet or information including electronic mail transmission and information recorded on websites, etc.

Claims

1. An infusion system comprising: Infusion device; as well as The processor is configured as follows: The infusion device is controlled to cause fluid to flow in the jet channel during a first time period, wherein the flow rate of the fluid is set to a first flow rate; After the first time period, the infusion device is controlled to suspend fluid flow in a second time period; After the flow is paused in the second time period and at the same time as the flow is paused, a measurement of the first pressure at the location along the jet channel is received during the second time period. After measuring the first pressure, the infusion device is controlled to increase the fluid flow from a suspended flow to a second flow rate significantly higher than the first flow rate during a third time period. After the third time period, the infusion device is controlled to suspend fluid flow in the fourth time period; After the flow is paused in the fourth time period and at the same time as the flow is paused, a measurement of the second pressure at the location is received during the fourth time period. After measuring the second pressure, the infusion device is controlled to reduce the fluid flow from a paused flow to a flow rate significantly lower than the second flow rate; Calculate the difference between the first pressure and the second pressure; Determine whether the magnitude of the difference between the first pressure and the second pressure meets a threshold. as well as Based on the determination that the magnitude of the difference satisfies the threshold, An indication of blockage is displayed at the output of the infusion device.

2. The infusion system according to claim 1, wherein, The processor is further configured as follows: Receive the option to change the blocking detection mode; and Based on receiving the aforementioned selection: After receiving the selection to change the congestion detection mode, the flow rate is paused in the fifth time period; The third pressure was measured at the beginning of the fifth time period; The fourth pressure was measured at the end of the fifth time period; as well as The processor calculates a second difference between the third pressure and the fourth pressure. Determine whether the value of the second difference meets the second threshold; as well as Based on the determination that the magnitude of the second difference satisfies the second threshold, an indication of the presence of the blockage is provided at the output of the infusion device.

3. The infusion system according to claim 2, wherein, The processor is further configured to stop fluid delivery and display an alarm indicating a blockage when the magnitude of the second difference is equal to or less than the second threshold.

4. The infusion system according to claim 2, wherein, The processor is further configured to continue fluid infusion when the magnitude of the second difference is greater than the second threshold.

5. The infusion system according to claim 1, wherein, Fluid is injected along the jet channel at a preset flow rate, and the preset flow rate is driven by an injection pump operating in a pulse mode, the pulse mode comprising pulses of fluid flow following a period of pause in fluid flow.

6. The infusion system according to claim 1, wherein, The processor is further configured to stop the fluid delivery and display an alarm indicating downstream blockage when the first pressure is less than the second pressure and the difference is greater than the threshold.

7. The infusion system according to claim 1, wherein, The processor is further configured to stop fluid delivery and display an alarm indicating an upstream blockage when the first pressure is greater than the second pressure and the magnitude of the difference is greater than the threshold.

8. The infusion system according to claim 1, wherein, Calculating the difference between the first pressure and the second pressure includes determining the slope of the rise in the jet pressure of the fluid in the jet channel in response to a downstream pressure sensor detecting the difference.

9. The infusion system according to claim 1, wherein, Calculating the difference between the first pressure and the second pressure includes determining the slope of the decrease in jet pressure of the fluid in the jet channel in response to the upstream pressure sensor detecting the difference.

10. The infusion system according to claim 1, wherein, The product of the second flow rate and the third time period is on the order of microliters.

11. The infusion system according to claim 1, wherein, When the first pressure is less than the second pressure and the difference is greater than the threshold, the blockage includes downstream blockage.

12. The infusion system according to claim 1, wherein, When the first pressure is greater than the second pressure and the magnitude of the difference is greater than the threshold, the blockage includes upstream blockage.

13. The infusion system according to claim 1, wherein, The processor is further configured as follows: The average value of the detected pressure is calculated over a first duration within the second time period to obtain the first pressure; and the average value is calculated over a second duration within the fourth time period to obtain the second pressure.

14. The infusion system according to claim 13, wherein, The first duration is several hundred milliseconds.

15. The infusion system according to claim 1, wherein, The processor is further configured to obtain an average difference by calculating an additional pressure difference at the location at different time intervals, and to provide an indication of the presence of the blockage when the magnitude of the average difference meets the threshold.

16. The infusion system according to claim 1, wherein, Providing an indication of the presence of blockage includes providing an indication at the output of the infusion device after repeated calculations and determination of the set number of times.

17. The infusion system according to claim 16, wherein, Providing an indication of the presence of a blockage includes incrementing a counter value each time the magnitude of the difference is determined to satisfy the threshold, and providing an indication of the presence of a blockage when the value of the counter equals a set number of times.

18. The infusion system according to claim 1, wherein, The processor is further configured to adjust the duration of the third time period and the value of the second flow rate.

19. The infusion system according to claim 1, wherein, The flow rate distribution curve is formed by the first flow rate, the second flow rate, and the third flow rate, and the infusion device generates the flow rate distribution curve to detect the blockage.

20. The infusion system according to claim 1, wherein, Indication is provided at the output of the infusion device, including the sounding of an alarm at the infusion device.

21. The infusion system according to claim 1, wherein, Indications are provided at the output of the infusion device, including displaying warning messages on the display screen of the infusion device.

22. The infusion system according to claim 1, wherein, The processor is the processor of the infusion device.

23. The infusion system according to claim 1, wherein, The processor is the processor of the server, and the infusion device communicates electronically with the server.

24. The infusion system according to claim 1, wherein, The threshold is adaptively adjusted, at least in part, based on the parameters of the infusion device.

25. The infusion system according to claim 24, wherein, The threshold is adaptively adjusted between the first pressure and the second pressure.

26. The infusion system according to claim 1, wherein, The processor is further configured to use machine learning to determine the threshold.

27. The infusion system according to claim 26, wherein, Using machine learning involves training a dataset with threshold values ​​associated with known congestion conditions.

28. The infusion system according to claim 1, wherein, The third time period is shorter than the second time period.

29. A non-transitory machine-readable storage medium containing instructions that, when executed by a machine, allow the machine to perform a method for detecting obstruction in a jet channel of an infusion apparatus, the method comprising: During a first time period, fluid is allowed to flow within the jet channel, wherein the flow of the fluid is set to a first flow rate; After the first time period, the fluid flow is paused for a second time period; After the flow is paused in the second time period and at the same time as the flow is paused, a first pressure is measured at a location along the jet channel during the second time period. After measuring the first pressure, the fluid flow is increased from a paused flow to a second flow rate that is significantly higher than the first flow rate during a third time period; After the third time period, the fluid flow is paused for a fourth time period; After the flow is paused in the fourth time period and at the same time as the flow is paused, the second pressure during the fourth time period is measured. After measuring the second pressure, the control delivery device reduces the fluid flow from a paused flow to a flow rate significantly lower than the second flow rate; The difference between the first pressure and the second pressure is calculated at the processor. Determine whether the magnitude of the difference between the first pressure and the second pressure meets a threshold. as well as Based on the determination that the magnitude of the difference satisfies the threshold, an indication of the presence of obstruction is provided at the output of the infusion device.

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