Blockage detection systems and methods for flow control devices

By installing pressure sensors and force sensors in the feeding pump and detecting blockages with specific algorithms, the problem of inaccurate blockage detection in the feeding products in the prior art is solved, and the blockage detection effect of high accuracy and low false alarms is achieved.

CN119744187APending Publication Date: 2025-04-01KPR U S LLC
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Patent Information

Application Number
CN202380058932.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-08-10
Filing Date
2023-08-10
Publication Date
2025-04-01

AI Technical Summary

Technical Problem

The prior art is difficult to effectively detect and distinguish the blockages in thick formula feeding, especially in high viscosity feeding and mixed tube feeding, which are prone to false blockage alarms, affecting the treatment effect of patients.

Method used

By installing a pressure sensor in the feeding pump, the pressure attenuation at the end of the feeding cycle is measured, combined with the force sensor data, a specific algorithm (such as the C-A value and the ΔLy average) is used to detect the blockage and avoid false alarms.

Benefits of technology

Accurate detection of blockage in dense formula feeding products is achieved, reducing the occurrence of false alarms, and ensuring the quality and safety of nutrients received by patients.

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Abstract

A flow control system and method that detects the condition of a pump assembly mounted on a device. The system is configured to perform a method of advancing a first amount of a feed recipe through a feed pump via a feed recipe conduit. In addition, the system may obtain a first pressure sensor reading of the feed recipe conduit. Further, the system may propel a second amount of the feed formulation through the feed pump via the feed formulation conduit, where the second amount is a second volume of the liquid. Further, the system may acquire a second pressure sensor reading of the feed recipe conduit and acquire a third pressure sensor reading of the feed recipe conduit. Further, the system may detect clogging in the feed recipe conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.
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Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 396,882, filed on August 10, 2022, entitled "OCCLUSION DETECTION SYSTEM AND METHOD FOR A FLOW CONTROL APPARATUS," which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to a flow control system and method capable of detecting the condition of a pump assembly mounted on a device, and more particularly, to blockage detection for thick formula feedings. Background Art

[0004] Administration of fluids containing medications or nutrients to a patient is well known in the art. Typically, the fluid is delivered to the patient by a pump assembly that is contained by a flow control device (such as a pump) that is connected to a fluid source that delivers the fluid to the patient. The flow control device may be capable of monitoring and detecting fluid flow conditions that may occur within a loaded administration feeding assembly during operation of the flow control device. Typically, a flow monitoring system capable of monitoring and detecting flow conditions may rely on a sensor disposed relative to the administration feeding assembly. Summary of the invention

[0005] A simplified overview of one or more implementations of the present disclosure is presented below in order to provide a basic understanding of such implementations. This overview is not an extensive overview of all contemplated implementations, and is neither intended to identify key or important elements of all implementations nor to delineate the scope of any or all implementations. Its sole purpose is to present some concepts of one or more implementations of the present disclosure in a simplified form as a prelude to a more detailed description presented later.

[0006] In one aspect, the present disclosure provides a system, method, and non-transitory computer-readable medium storing computer-executable instructions that can be executed by a processor for detecting the flow of a fluid via a control device. The system, method, and non-transitory computer-readable medium may include: a housing configured to house a feeding assembly, a pumping device, and a processor, the housing being configured to house a feeding assembly; the pumping device being configured to generate a fluid flow in the feeding assembly; the processor being configured to determine a blockage in the fluid flow based on sensor detection; wherein the fluid flow has a thick formula.

[0007] In some aspects, the technology described herein relates to a method for detecting an occlusion in a feeding pump, the method comprising: determining when a feeding assembly including a liquid is engaged in a feeding pump, wherein the liquid is a feeding formula; advancing a first amount of the feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid; obtaining a first pressure sensor reading of the feeding formula conduit; advancing a second amount of the feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; obtaining a second pressure sensor reading of the feeding formula conduit; obtaining a third pressure sensor reading of the feeding formula conduit; and detecting when an occlusion exists in the feeding formula conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

[0008] In some aspects, the technology described herein relates to a feeding pump configured for occlusion detection, comprising: one or more memories; and one or more processors, the one or more processors coupled to the one or more memories and configured, alone or in combination, to: determine when a feeding assembly comprising a liquid is engaged in the feeding pump, wherein the liquid is a feeding formula; advance a first amount of the feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid; obtain a first pressure sensor reading of the feeding formula conduit; advance a second amount of the feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; obtain a second pressure sensor reading of the feeding formula conduit; obtain a third pressure sensor reading of the feeding formula conduit; and detect when an occlusion exists in the feeding formula conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

[0009] In some aspects, the technology described herein relates to a computer-readable medium comprising stored instructions for occlusion detection, wherein the instructions are executable by one or more processors, alone or in combination, to: determine when a feeding assembly comprising a liquid is engaged in a feeding pump, wherein the liquid is a feeding formula; advance a first amount of the feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid; obtain a first pressure sensor reading of the feeding formula conduit; advance a second amount of the feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; obtain a second pressure sensor reading of the feeding formula conduit; obtain a third pressure sensor reading of the feeding formula conduit; and detect when an occlusion exists in the feeding formula conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

[0010] In some aspects, the technology described herein relates to a feeding assembly configured for blockage detection of a feeding pump, comprising: a liquid and a feeding formula line, wherein the liquid is a feeding formula, and the feeding pump is configured to advance a first amount of the feeding formula through the feeding formula line, the first amount being a first volume of the liquid; wherein the feeding pump is further configured to: obtain a first pressure sensor reading of the feeding formula line; advance a second amount of the feeding formula through the feeding pump via the feeding formula line, wherein the second amount is a second volume of the liquid; obtain a second pressure sensor reading of the feeding formula line; obtain a third pressure sensor reading of the feeding formula line; and detect when a blockage exists in the feeding formula line based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

[0011] Additional advantages and novel features associated with implementations of the present disclosure will be set forth in part in the description that follows and in part will become apparent upon examination of the following or upon learning by practice thereof. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The novel features believed to be characteristic of the present disclosure are set forth in the appended claims. In the following description, like parts are designated by the same reference numerals throughout the specification and drawings, respectively. The drawings are not necessarily drawn to scale, and certain drawings may be shown in exaggerated or generalized form for the sake of clarity and conciseness. However, the disclosure itself, as well as the preferred modes of use, further objects and improvements thereof, will be best understood by reference to the following detailed description of illustrative aspects of the disclosure when read in conjunction with the accompanying drawings, in which:

[0013] Figure 1 is a perspective view of a fragmentary portion of an example enteral feeding pump and a feeding assembly (feeding / irrigation) housed on the pump according to aspects of the present disclosure;

[0014] Figure 2 yes Figure 1 A perspective view of the feeding assembly with the cassette housing removed;

[0015] Figure 3 yes Figure 2 A perspective view of the invention with the feed assembly removed;

[0016] Figure 4 is a block diagram illustrating components of an example enteral feeding pump including a flow monitoring system according to aspects of the present disclosure;

[0017] Figure 5 is a flow chart of an example method of a jam detection routine according to an implementation of the present disclosure;

[0018] Figure 6is an example block diagram of various hardware components and other features of a computer system that may operate an access control system according to aspects of the present disclosure;

[0019] Figure 7 is a block diagram of various example system components used in accordance with aspects of the present disclosure; and

[0020] Figure 8A-Figure 8N Example results associated with a jam detection routine are shown in accordance with implementations of the present disclosure.

[0021] Corresponding reference characters indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION

[0022] Now refer to Figure 1-Figure 3 In the exemplary aspects schematically shown in the accompanying drawings, an enteral feeding pump (broadly, a "flow control device") is interchangeably referred to as a "pump" in the following disclosure and is generally indicated at 1. Pump 1 may include a housing 3 and a feeding assembly (broadly, a "pump set"), wherein housing 3 is configured to be mounted on a cassette, generally indicated at 5, and the feeding assembly is generally a segmented portion, generally indicated at 7, which is removably received in the cassette. Feeding assembly 7 may include a tube, generally indicated at 77, which provides a fluid path between a source of nutrient liquid and an irrigation liquid ( Figure 1 ). The left tube 77 can be considered to be the upstream tube portion connected to the feeding bag, while the right tube 77 can be considered to be the upstream tube portion connected to the flushing bag. Tube 83 provides a fluid path from the pump 1 to the user. In aspects of the present disclosure, the end user can be one of the patient or the administrator of the enteral feeding pump. As will be explained in more detail below, the pump 1 can include a flow monitoring system 6 ( Figure 4 ), which is capable of detecting and identifying the condition of the feeding assembly 7 loaded on the pump. More specifically, for blockage detection of thick formula feedings. As used herein, the term "loaded" refers to the engagement of the feeding assembly 7 with the pump 1 so that the feeding assembly is ready to operate with the pump to deliver fluid to the patient. As used herein, the term "conduit" refers to a tube section.

[0023] In the aspect shown, the cartridge 5 is removably received in a cartridge recess 8 in the housing 3 ( Figure 3). It should be understood that "housing" as used herein may include many forms of support structures (not shown), including but not limited to multi-part structures and structures that do not enclose or house the working parts of the pump 1. In addition, various aspects and features of the present disclosure can be implemented without the recess 8. The pump 1 may also include a display screen 9 on the housing 3, and the display screen 9 is capable of displaying information related to the status and operation of the pump. One or more buttons 11 that can access the display screen 9 can be provided for controlling the pump 1 and obtaining information from the pump 1, and one or more light emitting devices ("light emitting devices, LEDs") 13 can provide status information for the pump. In one aspect of the present disclosure, the light emitting device can be any form of device that emits light, such as an optical fiber, a light emitting diode, etc. For example, the LED 13 can indicate the correct or incorrect function of the pump 1. In addition, for example, the LED can also indicate when the fluid is flowing or not flowing through the feeding assembly 7 correctly or incorrectly. Legs (not shown) can be provided at the bottom of the housing 3 to support the housing so that the display screen 9 is slightly angled upward for easy viewing by the user.

[0024] The display screen 9 may be part of a front panel (generally indicated at 19) of the housing 3 and may be detachably attached to the housing. The pump 1 may further include a pumping unit generally indicated at 23, the pumping unit including a pump motor 27 ( Figure 4 ). A battery (not shown) may be housed in the housing 3 for powering the pump motor. A power source other than a battery or batteries may be used to power a pump, which includes one or more prime movers that drive the pumping unit via a rotor shaft. Another example of a pump with a rotor shaft is disclosed in U.S. Patent Publication No. 2020 / 0352827, which is incorporated herein by reference in its entirety.

[0025] The pumping unit 23 may have a rotor (generally indicated at 37) which may be coupled to a rotor shaft. The rotor 37 may include an inner disk 39, an outer disk 41, and rollers 43 (preferably four, but only two of which are indicated). The inner disk 39 and the outer disk 41 are preferably located in parallel planes, spaced apart from each other, and rotatable about a common axis. The rollers 43 are mounted between the inner disk 39 and the outer disk 41 for planetary rotation about the common axis of the disks 39, 41. Each roller 43 is also mounted to the disks 39, 41 for rotating relative to the disks 39, 41 about its own longitudinal axis ( Figure 2 and Figure 3 ) rotates, the longitudinal axis may be parallel to the common axis of the discs 39, 41. When the rollers 43 rotate about the axis of the discs 39, 41, they engage the tube 45 ( Figure 2) to deliver fluid through the feeding assembly to the patient via peristaltic engagement when the feeding assembly is contained in the box 5 and the box is attached to the housing 3. Other numbers of rollers are also contemplated and implemented. For example, but not limited to, five or six rollers may also be used without departing from the scope of the present disclosure.

[0026] Roller 43 can engage feeding assembly 7 so that fluid moves through feeding assembly. The delivery of fluid through feeding assembly can be referred to as providing aliquots of thick formula feed material below. In the aspects shown, pump motor 27, rotor shaft and rotor 37 can be broadly regarded as "pumping device". These components can be considered as "pumping device" individually. It will be understood that peristaltic pumps using mechanisms other than rollers can fall within the scope of the present disclosure. However, other pumping devices (e.g., non-rotating devices) can be envisioned.

[0027] As used herein, the portion of tube 77 of feeding assembly 7 that leads to rotor 37 is referred to as "upstream," while tube 83 that leads away from rotor 37 to the patient is referred to as "downstream." Rotation of rotor 37 compresses tube 45 of feeding assembly 7 to drive fluid (e.g., nutrient solution) from the upstream side of the feeding assembly to the downstream side in the direction of the patient. Although an example feeding assembly 7 is shown, other configurations of feeding assemblies and other types of pump assemblies (not shown) may be used.

[0028] refer to Figure 2-Figure 4 , Monitoring System 6( Figure 4 ) can detect and identify the condition of the feeding assembly 7 loaded on the device. For example, the condition of the feeding assembly 7 may relate to the flow of liquid through the assembly, whether the assembly is correctly installed on the pump, whether there is a blockage, or other conditions related to the feeding assembly or its operation. For example, the flow of liquid through the assembly can include a lack of liquid or an incorrect flow through the assembly. In addition, for example, if the assembly is not correctly installed on the pump, the fluid may not flow through the assembly correctly. In addition, for example, when the assembly is incorrectly installed on the pump, there may be a blockage in the tube.

[0029] The pump 1 may further include a microprocessor 62 in communication with the sensor 64. The microprocessor 62 can control and manage the operation of various components of the pump 1. The software subsystem 66 can be operably associated with the microprocessor 62 and operably associated with the monitoring system 6 to provide a means for the pump 1 to detect and identify the condition of the feeding assembly 7. It should be understood that in the described aspects, the flow monitoring system 6, the software subsystem 66, the pump electronics 68, the microprocessor 62 and the memory 70 can be broadly viewed as a "control circuit." These components can be individually viewed as a "control circuit." In addition, other types of control circuits can be used within the scope of the present disclosure. As described below with reference to Figure 6and Figure 7 As described, control circuitry may be implemented in association with various components. Switches 72 may include a plurality of switches, such as activation buttons, as described below.

[0030] Sensor 64 may include one or more ultrasonic sensors and / or pressure sensors. Sensor 64 may be located on housing 3 of pump 1 and positioned to detect the presence of fluid in feeding assembly 7 and one or more characteristics of the fluid, such as a blockage of fluid in the feeding assembly. In the illustrated aspect, sensor 64 is positioned in recess 8 and is adapted to securely receive a portion of tube 45 therein when feeding assembly 7 is loaded onto pump 1. In order for sensor 64 to detect the presence of fluid in tube 45 of feeding assembly 7, the tube may engage and be retained in sensor track 105 ( Figure 3 ), the sensor track 105 is configured to accommodate the upstream and downstream portions of the tube 45. Once the tube 45 is engaged in the sensor track 105 and the rest of the feeding assembly 7 is engaged with the pump 1, the monitoring system 6 can be operated. For example, when positive engagement of the tube 45 in the sensor track 105 is identified by receiving an acceptable signal (e.g., an ultrasonic signal) by one or more detectors or receivers, the monitoring system 6 can be operationally activated. The sensor 64 can be positioned perpendicular to the direction of the feeding assembly 7. For example, the sensor 64 can be positioned to read horizontally, while the feeding assembly 7 can be positioned to allow fluid to flow vertically.

[0031] In one aspect of the present disclosure, the sensor 64 may include: a first sensor component 107, 109 for transmitting ultrasonic signals through the upstream and downstream portions of the tube 45, respectively; and a second sensor component 107, 109 configured to receive and detect the ultrasonic signals transmitted from the first sensor component. Upon receiving the ultrasonic signals from the first sensor component 107, 109, the second sensor component 107, 109 may detect the presence of fluid in the tube 45 based on the characteristics of the ultrasonic signals received by the second sensor component and communicated to the microprocessor 62. The first and second sensor components 107, 109 may each include the same or substantially the same sensor configuration. For example, each sensor component 107, 109 may include an ultrasonic crystal, whereby each sensor component may operate as a transmitter for transmitting ultrasonic signals or as a detector for detecting ultrasonic signals, depending on the manner in which these components are powered. Therefore, the direction of the ultrasonic signal is not limited to a single direction between the sensor components 107, 109, but may be directed in two directions between the sensor components. In another aspect of the present disclosure, the sensor 64 may be a pressure sensor or a force sensor.

[0032] Sensor 64 can detect the presence or absence of fluid in the tube to give a basic indication of the operating status of pump 1. The ultrasonic signal emitted from sensor components 107, 109 can respond to the presence of fluid in tube 45, so that the fluid in the tube will produce an increase in signal amplitude compared to the signal when the fluid is not in the tube. In this way, an ultrasonic signal passing through an all-air medium will not produce a signal at the detector. Based on the characteristics of the received ultrasonic signal transmitted to microprocessor 62, software subsystem 66 can determine whether there is fluid in feeding assembly 7. In addition to ultrasonic sensors, other types of sensors for measuring one or more fluid properties or characteristics (including viscosity) can be used. The flow monitoring system 6 can also detect other conditions of feeding assembly 7, fluid in feeding assembly, and fluid coupled to feeding assembly without departing from the scope of the present disclosure.

[0033] In one aspect of the present disclosure, the pump 1 described above can be configured to operate with thickened enteral formulas and blended tube feeds ("blenderized tube feed, BTF"). Thickened enteral formulas and BTF are administered to prevent or reduce complications and intolerance symptoms associated with enteral nutrition, such as nausea, vomiting, and gastroesophageal reflux. However, the increased force required to push high viscosity feeds through connectors and tubes often causes false blockage alarms when administered via an enteral feeding pump. In addition, the administration of blended tube feeds may be complicated by solid food fragments clogging the feeding tube.

[0034] The International Dysphagia Diet Standardization Initiative (IDDSI) is a global standard with terms and definitions for describing texture-modified foods and thickened liquids for individuals. The IDDSI framework consists of 8 levels (0-7) in a row. For example, the levels are as follows: 7 is regular food; 6 is soft and palatable food; 6 is small pieces and moist food; 4 is pureed food / very thick; 3 is liquefied food / medium thick; 2 is slightly viscous food; 1 is slightly thick food; 0 is thin food. In addition, the IDDSI framework has two different parts, solid food and liquid. Specifically, solid food is classified into levels 3-7 and liquid is classified into levels 0-4. Therefore, levels 3 and 4 overlap between solid food and liquid. In one aspect of the present disclosure, fluids used for feedings referred to as high-viscosity feeds, thickened enteral formulas, or blended tube feeds are rated between levels 2-4 on the IDDSI framework. In another aspect of the present disclosure, fluids referred to as high viscosity feeds, thickened enteral formulas, or for use with blended tube feeds also include slightly thick foods, thin foods, and liquids that are rated between 0-4 on the IDDSI framework.

[0035] Steering Figure 5 , which shows a flowchart of an example method 500 of a jam detection routine according to an implementation of the present disclosure. Specifically, Figure 5 Concerning a blockage detection routine for high viscosity feedstock and the above Figure 1-Figure 4 Pump 1 shown. Most occlusion detection algorithms with pumps use a force sensor to detect an increase in pressure within the tube, which may indicate that an occlusion is restricting the flow of enteral nutrition. Due to their high viscosity, normal pumping of thickened enteral formulas and blended tube feeds often exceeds a force threshold that might otherwise indicate that the feeding assembly is blocked. Typically, blended tube feeds are administered via a syringe or gravity feed to avoid the use of an enteral feeding pump that causes false occlusion alarms. Prior to administration via a feeding pump, the nurse and / or caregiver may dilute the blended tube feed with 2-8 ounces of fluid. The addition of this fluid may exceed the volume of food that the patient can tolerate and limit the patient's ability to receive adequate calories. In addition, sometimes nurses and / or caregivers modify pumps and / or feeding assemblies to override safety features, thereby turning off occlusion detection and avoiding false alarms.

[0036] In view of these known problems, in order to distinguish between thin, commercial formulas that build pressure when there is a blockage and thick formulas that are usually pumped without blockage, method 500 measures the pressure decay at the end of the feeding cycle. For example, a pressure decay equal to or exceeding about 4 pounds per square inch (psi) may indicate that the feeding assembly is not blocked. In another example, for example, a pressure decay equal to or exceeding about 3psi may indicate that the feeding assembly is not blocked. These thresholds of 3psi and 4psi are examples and depend on the fluid flow rate, for example, mL / hr. If the decay does not occur at the end of the feeding cycle, the relative pressure change of the feeding assembly is evaluated. During the feeding cycle, a relative pressure increase of about 5psi may indicate a blockage. If the feeding assembly is installed in a pump 1 with an existing blockage, the pump 1 will not sense a significant pressure decay at the end of the feeding cycle, and may not sense a significant pressure increase during feeding. In this example, the force values ​​associated with the last 12 aliquots are evaluated for unstable behavior. Although 12 aliquots are examples, any number of aliquots can be averaged. In a blocked feeding assembly, the average change in the magnitude of the force reading obtained after conveying each aliquot is >= 3PSI. In an unblocked feeding assembly, the force readings obtained by aliquot to aliquot are more stable. In addition to these basic steps, when the fluid in the thick formula assembly is detected at installation, the rotor advances 0.5 aliquots before the cassette valve opens. When the valve is opened at the beginning of feeding, any residual pressure is released, and the feeding assembly is returned to an unpressurized state. This returns the previously used assembly to a baseline condition and allows pressure changes to be easily assessed. Note that the threshold values ​​listed above are for example purposes and do not depart from the present disclosure as a whole, because threshold values ​​can be set based on different factors (e.g., feeding rate, tube size and / or IDDSI level, etc.).

[0037] As is known in the art, an aliquot is an amount that is an exact divisor of the total amount of a substance. The feeding cycle of X aliquots is determined by time. For example, 1 feeding cycle is 1 minute of feeding time. In addition, as described above, the PSI values / thresholds listed above are converted from the force readings using the calibration constants from the pump.

[0038] Turning to block 502 of method 500 for blockage detection of thick formula feeding, a thick formula box is loaded into or onto pump 1 by a nurse and / or caregiver. At block 504, the system determines whether fluid is present upstream. Pump 1 can be configured to run a fluid detection routine, thereby operating an ultrasonic sensor to transmit an ultrasonic signal through a portion of a tube to determine the condition of a feeding assembly. If the sensor reading is above a predetermined threshold, the pump provides an initial indication that fluid is present in the tube. If the sensor reading is equal to or below a predetermined threshold, the pump provides an indication that fluid is not present in the tube.

[0039] If the system determines that there is no fluid in the system, the system opens the valve at box 506. Figure 1-Figure 3 As described, valve 12 is the location where the upstream tube enters pump 1. Valve 12 closes / opens the lumen of the tube located in the feeding assembly and is a component of the box. Physical closing / opening is performed by rotating a mechanical mechanism on the pump, which cooperates with the box when installed in pump 1. At box 508, the system primes the box. The system can prime the box by filling the feeding tube with a portion of the blending tube feed. At box 510, the user presses the "start" button or activation button on pump 1. At box 512, the system collects data from the force sensor, as described above. The collected data is called "A value". The A value is a force reading obtained at the beginning of the first cycle of the feeding cycle before the system starts pumping in the normal aliquot-pause feeding algorithm. An example of a normal aliquot-pause feeding algorithm is disclosed in U.S. patent application No. 17 / 750,041, the entire contents of which are incorporated herein by reference. In addition, note that the force value is as PSI.

[0040] Returning to box 504, if the system determines that fluid is present upstream, the system moves to box 514. At box 514, the rotor advances 0.5 aliquots. At box 510, the "start" button or activation button on the pump 1 is pressed by the user. At box 516, the system opens the valve. At box 518, the system pauses, for example, for 2 seconds, but can be between 1-3 seconds. During the 2 second pause, the pressure in the system stabilizes. At box 520, the system collects data from the force sensor, as described above as the A value. At box 522, the rotor advances again 0.5 aliquots to complete the delivery of the first aliquot of the thickened enteral formula.

[0041] At frame 524, the system steps converge to perform the same steps, regardless of whether there is fluid upstream. At frame 524, the system performs feeding by an aliquot-pause thick formula feeding algorithm. As described above, the example of an aliquot-pause feeding algorithm is disclosed in U.S. Patent Application No. 17 / 750,041, the entire contents of which are incorporated herein by reference. At frame 536, the system collects data from a force sensor, as described above. The collected data is referred to as "L value". The L value is a force reading obtained after the final aliquot cycle that has been delivered but before the deliberate pause in the system. At frame 528, a deliberate pause is, for example, 5 seconds. On the other hand of the present disclosure, a deliberate pause can be between 2-7 seconds.

[0042] At box 530, the system collects data from the force sensor, as described above. The data collected is referred to as a "C value". The C value is a force reading obtained after an intentional pause at the end of a feeding cycle. For example, at box 528, the C value is taken after a 5 second pause in the system.

[0043] At box 532, the system subtracts the L value from the C value and determines whether the result is less than or equal to a first threshold value (X1) in PSI. The first threshold value can be between -10PSI and 2PSI, more specifically, between -6PSI and -2PSI, more specifically -4PSI. If the comparison is yes, then at box 540 it is determined that the system is not blocked. If the result is greater than the first threshold value, then the system moves to box 534.

[0044] At box 534, the system subtracts the A value from the C value and determines whether the result is greater than or equal to a second threshold value (X2) in PSI. The second threshold value can be between 0PSI and 10PSI, more specifically, between 4PSI and 8PSI, more specifically 5PSI. If the comparison is yes, the system is determined to be blocked. At box 538, the system triggers an alarm to notify the nurse / caregiver of the blockage. In one aspect of the present disclosure, the alarm can be visual, audible, or a combination thereof. The display 9 ( Figure 1 ) and / or LED 13 provide a visual alert to the user, and an audible alert can be provided to the user through the speaker. The user can be provided with an alert to correct, repair or adjust the problem with the system. If the result is less than the second threshold, the system moves to box 536.

[0045] At block 536, the system determines Δ Ly Is the average value greater than or equal to a third threshold value (X3) in PSI. The third threshold value may be between -6PSI and 8PSI, more specifically, between -2PSI and 5PSI, more specifically, 3PSI.Ly is the average change in the magnitude of the force readings obtained after each aliquot pause of the last two complete rotor revolutions. In one aspect of the present disclosure, this will be a total of 12 force readings. Note that this value may not include the C value. In addition, if the feeding rate is less than 21 mL / hour, only 11 force readings may be implemented for this calculation. If the comparison is yes, the system is determined to be blocked. At box 538, the system triggers an alarm to notify the nurse / caregiver of the blockage. If the comparison is no, it is determined at box 540 that the system is not blocked.

[0046] In addition, when pump 1 is operated in maximum dosage mode, frame 536 can also be implemented independently or subordinately to the downstream clogging algorithm. Maximum dosage mode is when pump 1 is operated at maximum feeding rate (e.g., 800mL / / hr). When standard feeding box (non-thick formula) is loaded into pump 1, maximum dosage mode can be obtained. When operating in maximum dosage mode, pump 1 can operate in a cycle of 6 minutes. Therefore, parts of the method and / or system (e.g., frame 536) can be implemented with any pump 1.

[0047] Aspects of the present disclosure may be described in the general context of computer executable instructions (such as program modules) executed by one or more computers or other devices. Computer executable instructions may be organized into one or more computer executable components or modules, including but not limited to routines, programs, objects, components, and data structures that perform specific tasks or implement specific abstract data types. Aspects of the present disclosure may be implemented with such components or modules of any number and organization. For example, aspects of the present disclosure are not limited to specific computer executable instructions or specific components or modules illustrated in the accompanying drawings and described herein. Other aspects of the present disclosure may include different computer executable instructions or components with more or less functionality than that illustrated and described.

[0048] Further, unless otherwise indicated, the order of implementation or execution of the operations in the aspects of the present disclosure shown and described herein is not necessary. That is, unless otherwise specified, the operations can be performed in any order, and aspects of the present disclosure may include more or fewer operations than those disclosed herein. For example, it is expected that implementing or performing a particular operation before, simultaneously with, or after another operation is within the scope of aspects of the present disclosure.

[0049] In operation, the microprocessor 62 executes computer executable instructions (such as those shown in the figure) to implement aspects of the present disclosure. Aspects of the present disclosure can also be practiced in a distributed computing environment in which tasks are performed by remote processing devices linked via a communication network. In a distributed computing environment, program modules can be located in local and remote computer storage media including memory storage devices.

[0050] Aspects of the present disclosure may be implemented using hardware, software, or a combination thereof, and may be implemented in one or more computer systems or other processing systems. In aspects of the present disclosure, features relate to one or more computer systems capable of performing the functions described herein. Figure 6 An example of such a computer system 600 is shown in .

[0051] Computer system 600 includes one or more processors, such as processor 604. Processor 604 is connected to communication infrastructure 606 (e.g., a communication bus, a crossbar, or a network). Different software implementations are described with respect to this example computer system. After reading this description, it will become apparent to those skilled in the relevant art how to implement the disclosed implementations using other computer systems and / or architectures.

[0052] The computer system 400 may include a display interface 602 that forwards graphics, text, and other data from the communication infrastructure 606 (or from a frame buffer not shown) for display on a display unit 630. The computer system 600 also includes a main memory 608, preferably a random access memory (RAM), and may also include a secondary memory 610. The secondary memory 610 may include, for example, a hard disk drive 612 and / or a removable storage drive 614, which represents a floppy disk drive, a tape drive, an optical disk drive, a universal serial bus (USB) flash drive, etc. The removable storage drive 614 reads from and / or writes to a removable storage unit 618 in a well-known manner. The removable storage unit 618 represents a floppy disk, a tape, an optical disk, a USB flash drive, etc., which is read by and written to the removable storage drive 614. As will be appreciated, the removable storage unit 618 includes a computer-usable storage medium having computer software and / or data stored therein.

[0053] Alternative implementations of the present disclosure may include secondary memory 610, and may include other similar devices for allowing computer programs or other instructions to be loaded into computer system 600. Such devices may include, for example, a removable storage unit 622 and an interface 620. Such examples may include a program cartridge and cartridge interface (such as that found in video game devices), a removable memory chip (such as an erasable programmable read only memory (EPROM) or a programmable read only memory (PROM)) and an associated socket, and other removable storage units 622 and interfaces 620 that allow software and data to be transferred from the removable storage unit 622 to the computer system 600.

[0054] The computer system 600 may also include a communication interface 624. The communication interface 624 allows software and data to be transferred between the computer system 600 and external devices. Examples of the communication interface 624 may include a modem, a network interface (such as an Ethernet card), a communication port, a PCMCIA slot and card, etc. The software and data transmitted via the communication interface 624 are in the form of a signal 628, which may be an electronic, electromagnetic, optical or other signal that can be received by the communication interface 624. These signals 628 are provided to the communication interface 624 via a communication path (e.g., a channel) 626. The path 626 carries the signal 628 and may be implemented using a wire or cable, an optical fiber, a telephone line, a cellular link, a radio frequency (RF) link and / or other communication channels. In this document, the terms "computer program medium" and "computer-usable medium" are used to refer generally to media such as a removable storage unit 618, a hard disk installed in a hard disk drive 612, and a signal 628. These computer program products provide software to the computer system 600. Embodiments of the present disclosure relate to such a computer program product.

[0055] Computer programs (also referred to as computer control logic) are stored in the main memory 608 and / or the secondary memory 610. The computer programs may also be received via the communication interface 624. Such computer programs, when executed, enable the computer system 600 to perform features according to implementations of the present disclosure, as discussed herein. Specifically, the computer programs, when executed, enable the processor 604 to perform features according to implementations of the present disclosure. Thus, such computer programs represent controllers of the computer system 600.

[0056] In aspects where the present disclosure is implemented using software, the software may be stored in a computer program product and loaded into the computer system 600 using a removable storage drive 614, a hard disk drive 612, or a communication interface 620. The control logic (software), when executed by the processor 604, causes the processor 604 to perform the functions described herein. In another aspect of the present disclosure, the system is implemented primarily in hardware using, for example, hardware components such as an application specific integrated circuit (ASIC). It will be apparent to those skilled in the relevant art to implement a hardware state machine in order to perform the functions described herein.

[0057] Figure 7 is a block diagram of various example system components according to aspects of the present disclosure. Figure 7 A communication system 700 is shown, which includes one or more accessors 760 (also interchangeably referred to herein as one or more "users"), one or more terminals 742. Terminal 742 may include the above-mentioned system 100 and / or 200, or related systems, etc. In one aspect, data used according to aspects described herein can be input and / or accessed by accessor 760 via terminal 742, such as a personal computer (PC), a minicomputer, a mainframe computer, a microcomputer, a telephone device, or a wired / wireless device (such as a personal digital assistant (PDA) and an RFID (radio frequency identification device) reader (e.g., handheld, mobile, cabinet, etc.), which is coupled to a server 743, such as a PC, a minicomputer, a mainframe computer, a microcomputer, or other device having a processor and a repository for data and / or connected to the repository for data via, for example, a network 744 (such as the Internet or an intranet) and couplings 745, 746, 764. The couplings 745, 746, 764 may include wired, wireless or fiber optic links. In another example variation, methods and systems according to aspects described herein operate in a standalone environment, such as on a single terminal.

[0058] Aspects discussed herein may also be described and implemented in the context of computer-readable storage media storing computer-executable instructions. Computer-readable storage media include computer storage media and communication media, and may be flash drives, digital versatile discs (DVDs), compact discs (CDs), floppy disks, and magnetic tape cassettes. Computer-readable storage media may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storing information such as computer-readable instructions, data structures, modules, or other data.

[0059] refer to Figure 8A-Figure 8N , which shows example results associated with a jam detection routine according to an implementation of the present disclosure. Figure 8A-Figure 8N It indicates that Figure 5 Example results of the steps taken to determine and achieve the threshold in block 500.

[0060] refer to Fig. 8A , which shows the interval curve changes during the pause of the pump, as described above. In particular, the figure shows the difference in behavior between a blocked feeding assembly and an unblocked feeding assembly with 2-4 levels of various blended / thickened formulations IDDSI over time during the pump inactive period. The figure shows the change in pressure (psi) from time zero (L) (when the last aliquot was delivered in a given feeding cycle) to the elapsed time shown on the x-axis. This method shows that the unblocked feeding assembly provides a pressure drop during the inactive period that is not observed in the blocked assembly. Note that there is some overlap in the highlighted distributions.

[0061] refer to Figure 8B , which shows the second interval curve of the change during the pause period of the pump, as described above. Fig. 8A , but separated by formulation type. In particular, the graph shows that blended and generally thicker formulations (e.g., IDDSI Grade 4) exhibit a more significant drop during the pump's inactive time than more uniform and generally thinner formulations (e.g., IDDSI Grade 2).

[0062] refer to Figure 8C, which shows the distribution of unblocked blended formulations and blocked formulations. Specifically, the figure shows a histogram of the pressure change during the 5 second rest (pump inactivity) period from the time the last aliquot was delivered in the feeding cycle, comparing blocked feeding components (all formulation types) to unblocked blended formulations. The figure shows that there is a separation in the distribution that allows thresholds to be established. In particular, the figure provides the basis for how to derive the first part of the thick formulation blockage detection algorithm: (CL) <= -4 psi (as described above with reference to Figure 5 ), where the L value is the force reading obtained after the feeding cycle of the last aliquot that has been delivered, and the C value is the force reading obtained after an intentional 5 second pause. As described above, if this criterion is met, the system can determine that the feeding assembly is not blocked.

[0063] refer to Fig.8D , where a histogram of the C values ​​minus the A values ​​is shown for both blocked and unblocked homogeneous formulas. The figure shows that there is no pressure drop during the 5 second pause after the last aliquot was delivered in the feeding cycle. Specifically, the figure shows that there is a significant pressure increase only in the blocked component, as measured from the beginning of the first feeding cycle before pumping (value A) to 5 seconds after pump activity in a given feeding cycle (value C). Additionally, there is a separation in the distribution that allows a threshold to be established. Specifically, the figure provides the basis for how the second criterion of the thick formula blockage detection algorithm is derived: (CA)>=5psi (as described above with reference to Figure 5 534 as described above).

[0064] refer to Fig. 8E , which generally shows the Figure 8A-8D Flowchart / algorithm for interpreting data determination. Testing with various nasogastric (NG) tube sizes at several feeding rates using thick blended formula (IDDSI Grade 4) and water (IDDSI Grade 0) Fig. 8E The results of this test for normal conditions are shown in the following description Figure 8F Normal conditions indicate that an unobstructed feeding assembly is loaded onto the pump, the feeding assembly is then primed, feeding is started without problems, and an obstruction is simulated during normal feeding by clamping the feeding assembly. Figure 8F The conditions shown in are sufficient to detect blockage during these usage conditions.

[0065] Thick blended formula (IDDSI Grade 4) and water (IDDSI Grade 0) were tested at several feeding rates using various nasogastric tube sizes. Fig. 8E The accuracy of the algorithm. Figure 8GThe results of this test for an abnormal condition are shown in . The abnormal condition occurs when a blocked assembly is loaded onto the pump before feeding begins. Figure 8G The criteria shown in are not sufficient to detect blockage during this use condition.

[0066] refer to Figure 8H When observing force readings over time (as measured by an analog-to-digital conversion ADC (e.g., a digital value proportional to an analog measurement)), as shown by the aliquots in time sequence, there is a more erratic and noisy pressure profile in the blocked feed assembly compared to the unblocked feed assembly. This erratic behavior is quantified by taking the average change in magnitude from aliquot to aliquot (12 aliquots) over the last two rotor revolutions. The absolute value of the point-to-point difference in force is calculated and then averaged ((|F L-11 -F L-10 |+|F L-10 -F L-9 |+|F L-9 -F L-8 |+|F L-8 -F L-7 |+|F L-7 -F L-6 |+|F L-6 -F L-5 |+|F L-5 -F L-4 |+|F L-4 -F L-3 |+|F L-3 -F L-2 |+|F L-2 -F L-1 |+|F L-1 -F L- |) / 11). Although evaluating the standard deviation of the noise in the pressure response may not be necessary to characterize the noise relative to the mean, it may be implemented into the system / method. For example, the standard deviation may be implemented to further quantify trends and / or behaviors in any pressure signal reading.

[0067] refer to Figure 8I , shows the average change in pressure from aliquot to aliquot the last time the two rotors rotated between blocked and unblocked. In particular, the blocked feed assembly (abnormal condition, such as Figure 8G Described and shown, in the figure labeled High Pressure to High Pressure or H2H) is compared to an unblocked feeding assembly (in this case Low Pressure to Low Pressure labeled L2L). Figure 8I Various numerical graphs of this data are shown using 6 pumps, 4 different formulation types, and 2 different feed rates. Figure 8J-Figure 8LThe same data is shown, but broken down by pump, recipe type, and feed rate.

[0068] refer to Figure 8M , shows that the above considerations Figure 8A-8L Final flow chart of the decision tree for the thick recipe jam detection algorithm. For reference, as described above, the C force value is obtained at the end of the 1 minute period 5 seconds after the last aliquot was delivered. The L force value is obtained after the last aliquot was delivered. The force value is obtained immediately before the first aliquot is delivered at the beginning of the feed. Avg(Δ L12 ) is the average change in size from aliquot to aliquot over the last two rotor revolutions.

[0069] refer to Figure 8N , showing the results when using various pumps under test, feed rates, formulation types and usage conditions. Figure 8M The results of the test of the flow chart are shown in Figure 1. 99.4% of the blockages were detected after 3 1 minute feeding cycles, of which only 0.05% resulted in false alarms. These results are a significant improvement over a system that does not use an algorithm.

[0070] Although the aspects described herein have been described in conjunction with the example aspects summarized above, different alternatives, modifications, variations, improvements and / or substantial equivalents (whether known or currently unforeseeable or possibly currently unforeseeable) will be apparent to those skilled in the art. Therefore, the example aspects as set forth above are intended to be illustrative rather than restrictive. Various changes may be made without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to cover all known or later developed alternatives, modifications, variations, improvements and / or substantial equivalents.

[0071] Therefore, the claims are not intended to be limited to the aspects shown herein, but to be consistent with the full scope consistent with the language of the claims, wherein, unless specifically stated otherwise, reference to an element in the singular is not intended to mean "one and only one", but rather "one or more". All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to one of ordinary skill in the art are expressly incorporated herein by reference and are intended to be covered by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element should be interpreted as a component plus function unless the element is expressly recited using the phrase "component for..."

[0072] It should be understood that the specific order or hierarchy of the disclosed processes / flowcharts is an illustration of an example method. Based on design preferences, it should be understood that the specific order or hierarchy in the processes / flowcharts may be rearranged. Further, some features / steps may be combined or omitted. The attached method claims present elements of various features / steps in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0073] Further, the word "example" is used herein to mean "serving as an example, instance, or illustration." Any aspect described herein as an "example" is not necessarily to be construed as being preferred or advantageous over other aspects. Unless specifically stated otherwise, the term "some" refers to one or more. Combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" include any combination of A, B, and / or C, and may include multiple A, multiple B, or multiple C. Specifically, combinations such as "at least one of A, B, or C," "at least one of A, B, and C," and "A, B, C, or any combination thereof" may be only A, only B, only C, A and B, A and C, B and C, or A and B and C, wherein any such combination may include one or more members of A, B, or C. Regardless of whether such disclosure is explicitly recited in the claims, nothing disclosed herein is intended to be dedicated to the public.

Claims

1. A method for detecting blockage of a feeding pump, the method comprising: determining when a feeding assembly comprising a liquid is engaged in the feeding pump, wherein the liquid is a feeding formula; advancing a first amount of a feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid; obtaining a first pressure sensor reading of the feeding formula conduit; advancing a second amount of feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; Obtaining a second pressure sensor reading of the feeding formula conduit; obtaining a third pressure sensor reading of the feeding formula conduit; and Based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading, detecting when a blockage exists in the feeding formula conduit.

2. The method according to claim 1, wherein: The feeding formula was rated 0-4 on the International Dysphagia Diet Standardization Initiative IDDSI framework.

3. The method according to claim 2, wherein: The feeding recipes were further rated as level 2-4 on the IDDSI framework.

4. The method according to claim 1, further comprising: After advancing the first amount of feeding formula and before performing acquisition of the first pressure sensor reading, the feeding pump is paused for a predetermined period of time.

5. The method according to claim 4, wherein: The predetermined time period is 1-3 seconds.

6. The method according to claim 4, further comprising: After advancing the second amount of feeding formula and before performing the acquisition of the third pressure sensor reading, the feeding pump is paused for a second predetermined period of time.

7. The method according to claim 6, wherein: The feeding pump is paused for the second predetermined period of time after the acquisition of the second pressure sensor reading is performed.

8. The method according to claim 6, wherein: The second predetermined time period is 2-7 seconds.

9. The method according to claim 1, further comprising: After advancing the second amount of feeding formula and before performing the acquisition of the third pressure sensor reading, the feeding pump is paused for a predetermined period of time.

10. The method according to claim 9, wherein: The feeding pump is paused for the predetermined period of time after the acquisition of the second pressure sensor reading is performed.

11. The method according to claim 10, wherein: The predetermined time period is 2-7 seconds.

12. The method according to claim 1, wherein: The feeding formula conduit is a tube that is compressibly engaged with the rotor of the feeding assembly.

13. The method according to claim 1, wherein: The first volume of liquid and the second volume of liquid are an aliquot.

14. The method according to claim 1, wherein: Advancing the first amount primes the feeding assembly.

15. The method according to claim 1, further comprising: When the difference between the third pressure sensor reading and the second pressure sensor reading is less than or equal to X pounds per square inch (PSI), the feeding formula conduit is not blocked.

16. The method according to claim 1, further comprising: The feeding formula conduit is blocked when the difference between the third pressure sensor reading and the second pressure sensor reading is greater than X psi and when the difference between the third pressure sensor reading and the first pressure sensor reading is less than or equal to X2 psi.

17. The method of claim 1, further comprising: When the difference between the third pressure sensor reading and the second pressure sensor reading is greater than X PSI, and when the difference between the third pressure sensor reading and the first pressure sensor reading is greater than X2 PSI, and when the average of multiple previous second pressure sensor readings is greater than or equal to X3, the feeding formula conduit is blocked.

18. The method according to claim 17, wherein: X is between -10PSI and 2PSI, X2 is between 0PSI and 10PSI, and X3 is between -6PSI and 8PSI.

19. The method according to claim 18, wherein: X is between -6PSI and -2PSI, X2 is between 4PSI and 8PSI, and X3 is between -2PSI and 5PSI.

20. The method according to claim 19, wherein: X is -4PSI, X2 is 5PSI, and X3 is 3PSI.

21. The method according to claim 17, wherein: The plurality of previous second pressure sensor readings is less than or equal to 12 second pressure readings.

22. A feeding pump configured for occlusion detection, comprising: one or more memories; as well as one or more processors, the one or more processors being coupled to the one or more memories and configured, individually or in combination, to: determining when a feeding assembly comprising a liquid is engaged in the feeding pump, wherein the liquid is a feeding formula; advancing a first amount of a feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid; obtaining a first pressure sensor reading of the feeding formula conduit; advancing a second amount of feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; Obtaining a second pressure sensor reading of the feeding formula conduit; obtaining a third pressure sensor reading of the feeding formula conduit; and Based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading, detecting when a blockage exists in the feeding formula conduit.

23. A computer readable medium comprising stored instructions for occlusion detection, wherein: The instructions are executable by one or more processors, alone or in combination, to: determining when a feeding assembly including a liquid is engaged in a feeding pump, wherein the liquid is a feeding formula; advancing a first amount of a feeding formula through the feeding pump via a feeding formula conduit, wherein the first amount is a first volume of the liquid; obtaining a first pressure sensor reading of the feeding formula conduit; advancing a second amount of feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; Obtaining a second pressure sensor reading of the feeding formula conduit; obtaining a third pressure sensor reading of the feeding formula conduit; and Based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading, detecting when a blockage exists in the feeding formula conduit.

24. A feeding assembly configured for occlusion detection of a feeding pump, comprising: a liquid, wherein the liquid is a feeding formula; and a feeding formula conduit, wherein the feeding pump is configured to advance a first amount of a feeding formula through the feeding formula conduit, the first amount being a first volume of the liquid; Wherein, the feeding pump is further configured as: obtaining a first pressure sensor reading of the feeding formula conduit; advancing a second amount of feeding formula through the feeding pump via the feeding formula conduit, wherein the second amount is a second volume of the liquid; Obtaining a second pressure sensor reading of the feeding formula conduit; obtaining a third pressure sensor reading of the feeding formula conduit; and Based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading, detecting when a blockage exists in the feeding formula conduit.

Citation Information

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