Occlusion detection system and method for flow control devices

Abstract

A flow control system and method for detecting a condition of a pump set attached to an apparatus. The system is configured to perform a method for advancing a first amount of administered nutrient through an administration pump via an administered nutrient conduit. The system can further acquire a reading from a first pressure sensor in the administered nutrient conduit. The system can further advance a second amount of administered nutrient through the administration pump via the administered nutrient conduit, the second amount being a second volume of liquid. The system can further acquire a reading from a second pressure sensor in the administered nutrient conduit and a reading from a third pressure sensor in the administered nutrient conduit. The system can further detect an occlusion in the administered nutrient conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

Description

[Technical Field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Patent Application No. 63 / 396,882, entitled "OCCLUSION DETECTION SYSTEM AND METHOD FOR A FLOW CONTROL APPARATUS," filed August 10, 2022, which is incorporated herein by reference in its entirety.

[0002] [Technical field] FIELD OF THE DISCLOSURE The present disclosure relates generally to flow control systems and methods capable of detecting conditions in a pump set attached to a device, and more particularly to occlusion detection for the administration of viscous nutritional formulas. [Background technology]

[0003] Administering fluids, including medications or nutrients, to a patient is generally known in the art. Typically, the fluid is delivered to the patient by a pump set received by a flow control device, such as a pump, 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 an administration feeding set installed during operation of the flow control device. Generally, flow monitoring systems capable of monitoring and detecting flow conditions may rely on sensors positioned relative to the administration feeding set. Summary of the Invention [Means for solving the problem]

[0004] The following presents a simplified summary of one or more implementations of the present disclosure in order to provide a basic understanding of such implementations. This summary is not an extensive overview of all contemplated implementations, and is not intended to identify key or critical elements of all implementations or 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 the more detailed description that is presented later.

[0005] In one aspect, the present disclosure provides a system, method, and non-transitory computer-readable medium storing computer-executable instructions executable by a processor for detecting fluid flow through a control device. The system, method, and non-transitory computer-readable medium may include a housing configured to receive an administration set, a pump device configured to generate fluid flow within the administration set, and a processor configured to determine an occlusion in the fluid flow based on sensor detection, wherein the fluid flow is a viscous nutritional solution.

[0006] In some aspects, the technology described herein relates to a method of detecting an occlusion in an administration pump, the method including determining when an administration set containing a liquid is engaged with the administration pump, the liquid being a nutrient; advancing a first amount of the nutrient through the administration pump via a nutrient conduit, the first amount being a first volume of liquid; obtaining a first pressure sensor reading of the nutrient conduit; advancing a second amount of the nutrient through the administration pump via the nutrient conduit, the second amount being a second volume of liquid; obtaining a second pressure sensor reading of the nutrient conduit; obtaining a third pressure sensor reading of the nutrient conduit; and detecting when an occlusion is present in the nutrient conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

[0007] In some aspects, the technology described herein relates to an administration pump configured for occlusion detection, including one or more memories; and one or more processors coupled to the one or more memories and configured, individually or in combination, to determine when an administration set containing a liquid is engaged with the administration pump; advance a first quantity of administered nutrient through the administration pump via a nutrient conduit, the first quantity of the liquid; obtain a first pressure sensor reading of the administered nutrient conduit; advance a second quantity of administered nutrient through the administration pump via the nutrient conduit, the second quantity of the liquid; obtain a second pressure sensor reading of the administered nutrient conduit; obtain a third pressure sensor reading of the administered nutrient conduit; and detect when an occlusion is present in the administered nutrient conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading, wherein the liquid is the administered nutrient.

[0008] In some aspects, the techniques described herein relate to a computer-readable medium including stored instructions for occlusion detection, the instructions being executable by one or more processors, individually or in combination, to determine when an administration set containing a liquid is engaged with a nutritional pump; advance a first amount of administered nutrient through the nutritional pump via an administered nutrient conduit, the first amount being a first volume of liquid; obtain a first pressure sensor reading of the administered nutrient conduit; advance a second amount of administered nutrient through the nutritional pump via the administered nutrient conduit, the second amount being a second volume of liquid; obtain a second pressure sensor reading of the administered nutrient conduit; obtain a third pressure sensor reading of the administered nutrient conduit; and detect when an occlusion is present in the administered nutrient 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 an administration set configured for occlusion detection in a feeding pump, the administration set including a liquid that is a nutritional supplement and a nutritional supplement conduit, the feeding pump configured to advance a first amount of the nutritional supplement through the nutritional supplement conduit, the first amount being a first volume of the liquid, the feeding pump obtaining a first pressure sensor reading of the nutritional supplement conduit, advancing a second amount of the nutritional supplement through the nutritional supplement conduit and through the feeding pump, obtaining a second pressure sensor reading of the nutritional supplement conduit, obtaining a third pressure sensor reading of the nutritional supplement conduit, and detecting when an occlusion is present in the nutritional supplement conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

[0010] Additional advantages and novel features of implementations of the present disclosure will be set forth in part in the description that follows, and in part will become apparent to those skilled in the art upon examination of the description or learned by practice. [Brief explanation of the drawings]

[0011] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0012] The novel features believed characteristic of the present disclosure are set forth in the appended claims. In the following description, like parts will be designated throughout the specification and drawings with the same reference numerals. The drawings are not necessarily drawn to scale, and certain figures may be shown in exaggerated or generalized form for clarity and conciseness. However, the present disclosure itself, as well as its preferred modes of use, further objects and advances, will best be understood by reference to the following detailed description of illustrative aspects of the disclosure when read in conjunction with the accompanying drawings. [Figure 1]FIG. 1 is a fragmentary, partial perspective view of an exemplary enteral feeding pump and an administration set (administration / flush) received on the pump, according to an embodiment of the present disclosure. [Figure 2] FIG. 2 is a perspective view of FIG. 1 with the cassette housing of the administration set removed. [Figure 3] FIG. 3 is a perspective view of FIG. 2 with the administration set removed. [Figure 4] FIG. 1 is a block diagram illustrating elements of an exemplary enteral feeding pump including a flow monitoring system, according to aspects of the present disclosure. [Figure 5] 10 is a flowchart of an exemplary method of an occlusion detection routine, consistent with implementations of the present disclosure. [Figure 6] FIG. 1 is an exemplary 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. [Figure 7] FIG. 1 is a block diagram of various exemplary system components for use in accordance with aspects of the present disclosure. [Figure 8A] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8B] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8C] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8D] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8E] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8F] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8G] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8H] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8I]10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8J] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8K] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8L] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8M] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure. [Figure 8N] 10 illustrates example results associated with an occlusion detection routine according to one embodiment of the present disclosure.

[0013] Corresponding reference characters indicate corresponding parts throughout the drawings. DETAILED DESCRIPTION OF THE INVENTION

[0014] This will be explained in detail below.

[0015] Referring now to the exemplary embodiment shown schematically in FIGS. 1-3 , an enteral feeding pump (broadly a “flow control device”), hereinafter interchangeably referred to as the “pump” throughout this disclosure, is generally designated 1. Pump 1 can include a housing 3 configured to load a cassette, generally designated 5, an administration set (broadly designated a “pump set”), and a piecemeal portion, generally designated 7, removably received within the cassette. Administration set 7 can include tubing, generally designated 77, that provides a fluid path between a source of nutritional liquid and a flushing liquid ( FIG. 1 ). Left tube 77 can be considered the upstream tubing portion connected to an administration bag, and right tube 77 can be considered the upstream tubing portion connected to a flush bag. Tubing 83 provides a fluid path from pump 1 to a user. In embodiments of the present disclosure, the end user may be a patient or one of the administrators of the enteral feeding pump. As described in more detail below, pump 1 can include a flow monitoring system 6 ( FIG. 4 ) that can detect and identify the status of administration set 7 loaded into the pump. More specifically, for occlusion detection in the administration of viscous nutritional formulas. As used herein, the term "loading" means that the administration set 7 is engaged with the pump 1 so that the administration set is ready to operate with the pump to deliver fluid to a patient. As used herein, the term "conduit" means a tubing section.

[0016] In the illustrated embodiment, the cassette 5 is removably received in a cassette recess 8 of the housing 3 ( FIG. 3 ). It will be understood that “housing,” as used herein, can include many forms of support structure (not shown), including, but not limited to, multi-piece structures and structures that do not enclose or house the operating components of the pump 1. Additionally, various aspects and features of the present invention can be implemented without the recess 8. The pump 1 can also include a display screen 9 on the housing 3 that can display information regarding the status and operation of the pump. One or more buttons 11, which may be proximate to the display screen 9, can be provided for use in controlling and obtaining information from the pump 1, and one or more light-emitting devices (“LEDs”) 13 can provide pump status information. In one embodiment 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, or the like. For example, the LED 13 can indicate proper or improper functioning of the pump 1. Additionally, for example, the LEDs can also indicate when fluid is flowing properly, improperly, or not flowing through the administration set 7. Feet (not shown) may be placed at the bottom of the housing 3 to support the housing so that the display screen 9 is angled slightly upwards for ease of viewing by the user.

[0017] Display screen 9 may be part of the front panel (generally designated 19) of housing 3 or may be removably attached to the housing. Pump 1 may further include a pump unit, generally designated 23, including a pump motor 27 (FIG. 4) connected to a rotor shaft. A battery (not shown) may be housed within housing 3 to power the pump motor. Power sources other than, or in addition to, batteries can be used to operate a pump, including one or more prime movers that drive the pump unit via a rotor shaft. Another example of a pump having a rotor shaft is disclosed in U.S. Patent Application Publication No. 2020 / 0352827, the entire disclosure of which is incorporated herein by reference.

[0018] The pump unit 23 may have a rotor (generally designated 37) that 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, only two of which are shown). The inner disk 39 and the outer disk 41 preferably lie in parallel planes spaced apart from one another and are rotatable about a common axis. The rollers 43 are mounted between the inner disk 39 and the outer disk 41 for planetary rotation about a shared axis of the disks 39, 41. Each roller 43 is also mounted to the disks 39, 41 for rotation relative to the disks 39, 41 about its own longitudinal axis (FIGS. 2 and 3), which may be parallel to the shared axis of the disks 39, 41. As rollers 43 rotate about the axes of discs 39, 41, they engage tubing 45 (FIG. 2) of administration set 7, delivering fluid through the administration set to the patient via peristaltic engagement when the administration set is received within cassette 5 and the cassette is attached to housing 3. Other numbers of rollers may also be envisioned and implemented. For example, without limitation, five or six rollers may be used without departing from the scope of the present disclosure.

[0019] Rollers 43 may engage administration set 7 to move fluid through the administration set. Delivery of fluid through the administration set may hereinafter be referred to as providing an aliquot of a viscous nutritional formula. In the illustrated embodiment, pump motor 27, rotor shaft, and rotor 37 may be broadly considered a "pump device." These components may also be individually considered a "pump device." It is understood that peristaltic pumps using mechanisms other than rollers may be included within the scope of the present disclosure. However, other pump devices (e.g., non-rotating devices) are also contemplated.

[0020] As used herein, the portion of the tubing 77 of the administration set 7 that leads to the rotor 37 is referred to as "upstream," while the tubing 83 that leads away from the rotor 37 to the patient is referred to as "downstream." Rotation of the rotor 37 compresses the tubing 45 of the administration set 7, driving fluid (e.g., nutritional liquid) from the upstream side of the administration set to the downstream side toward the patient. While an exemplary administration set 7 is shown, other configurations of administration sets and other types of pump sets (not shown) can be used.

[0021] 2-4, the monitoring system 6 (FIG. 4) can detect and identify the status of an administration set 7 loaded into the device. For example, the status of the administration set 7 may relate to fluid flow through the set, whether the set is properly attached to the pump, whether there is an occlusion, or other conditions related to the administration set or its operation. For example, fluid flow through the set may include a lack of or improper flow of fluid through the set. Furthermore, for example, if the set is improperly attached to the pump, fluid may not flow properly through the set. Furthermore, for example, if the set is improperly attached to the pump, an occlusion may exist in the tubing.

[0022] The pump 1 may further include a microprocessor 62 communicatively associated with the sensor 64. The microprocessor 62 may control and manage the operation of various components of the pump 1. A software subsystem 66 may be operatively associated with the microprocessor 62 and with the monitoring system 6 to provide a means for the pump 1 to detect and identify the condition of the administration set 7. It should be understood that, in the described embodiment, the flow monitoring system 6, the software subsystem 66, the pump electronics 68, the microprocessor 62, and the memory 70 may be broadly considered a "control circuit." These components may be individually considered a "control circuit." Additionally, other types of control circuitry may be used within the scope of the present disclosure. As described below with reference to FIGS. 6 and 7, the control circuitry may be implemented in association with various components. The switch 72 may include multiple switches, such as a start button, as described below.

[0023] The sensor 64 may include one or more ultrasonic sensors and / or pressure sensors. The sensor 64 may be located on the housing 3 of the pump 1 and positioned to detect the presence of fluid as well as one or more characteristics of the fluid in the administration set 7, such as an occlusion of the fluid in the administration set. In the illustrated embodiment, the sensor 64 is disposed within the recess 8 and is adapted to securely receive a portion of the tubing 45 therein when the administration set 7 is loaded into the pump 1. For the sensor 64 to detect the presence of fluid in the tubing 45 of the administration set 7, the tubing may be engaged and held within a sensor track 105 ( FIG. 3 ) configured to receive upstream and downstream portions of the tubing 45. Once the tubing 45 is engaged within the sensor track 105 and the remainder of the administration set 7 is engaged with the pump 1, the monitoring system 6 may be operable; for example, the monitoring system 6 may become operative when secure engagement of the tubing 45 within the sensor track 105 is identified by receipt of an acceptable signal, such as an ultrasonic signal, by one or more detectors or receivers. The sensor 64 may be positioned perpendicular to the orientation of the administration set 7. For example, the sensor 64 may be positioned to read horizontally, while the administration set 7 may be positioned to direct fluid flow vertically.

[0024] 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 pipe 45, respectively, and a second sensor component 107, 109 configured to receive and detect the ultrasonic signals emitted 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 within the pipe 45 based on 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 identical or substantially identical sensor configurations. For example, each sensor component 107, 109 may include an ultrasonic crystal, thereby allowing each sensor component to operate as a transmitter for transmitting ultrasonic signals or as a detector for detecting ultrasonic signals, depending on how the component is energized. Thus, the direction of the ultrasonic signal is not limited to a single direction between the sensor components 107, 109, but instead may be directed in both directions between the sensor components. In another aspect of the present disclosure, the sensor 64 may be a pressure sensor or a force sensor.

[0025] The sensor 64 may detect the presence or absence of fluid in the tubing to provide a basic indication of the operating status of the pump 1. The ultrasonic signals emitted from the sensor components 107, 109 may respond to the presence of fluid in the tubing 45 such that fluid in the tubing generates an increase in the amplitude of the signal compared to the signal when no fluid is in the tubing. Thus, an ultrasonic signal that passes through all air media will not generate a signal at the detector. Based on the characteristics of the received ultrasonic signal communicated to the microprocessor 62, the software subsystem 66 may determine whether fluid is present in the administration set 7. Other types of sensors, other than ultrasonic sensors, for measuring one or more fluid properties or characteristics, including viscosity, may be used. The flow monitoring system 6 may also detect other conditions of the administration set 7, the fluid in the administration set, and the fluid coupled to the administration set without departing from the scope of this disclosure.

[0026] In one embodiment of the present disclosure, the pump 1 described above can be configured to operate with thickened enteral nutrition formulas and mixed tube feedings ("BTF"). Thickened enteral nutrition formulas and BTF are administered to prevent or reduce enteral nutrition-related complications and intolerance symptoms, such as nausea, vomiting, and gastroesophageal reflux. However, greater force is required to push highly viscous dosages through connectors and tubing, which often causes false blockage alarms when administered via an enteral feeding pump. Additionally, administration of mixed tube feedings can be complicated by small pieces of solid food that can clog the feeding tube.

[0027] The International Dysphagia Diet Standardization Initiative (IDDSI) is a global standard with terminology and definitions for describing texture-modified foods and thickened liquids used by individuals. The IDDSI framework consists of a continuum of eight levels (0-7). The levels are, for example, as follows: 7 is normal food; 6 is soft, bite-sized food; 5 is minced, moist food; 4 is pureed food / highly viscous; 3 is liquid food / moderately viscous; 2 is slightly viscous food; 1 is slightly viscous food; and 0 is non-viscous food. Furthermore, the IDDSI framework has two distinct parts: solid foods and liquids. Specifically, solid foods are classified as levels 3-7, and liquids are classified as levels 0-4. Thus, levels 3 and 4 overlap between solid foods and liquids. In one embodiment of the present disclosure, fluids designated for use with high-viscosity administration, thickened enteral formulas, or mixed tube feedings are rated between levels 2 and 4 on the IDDSI framework. In another aspect of the present disclosure, fluids referred to as for use with high viscosity dosages, thickened enteral nutritional formulas, or mixed tube dosages also include slightly viscous foods, non-viscous foods, and liquids rated between levels 0 and 4 on the IDDSI framework.

[0028] Referring to FIG. 5, a flowchart of an exemplary method 500 of an occlusion detection routine according to one embodiment of the present disclosure is shown. Specifically, FIG. 5 is directed to an occlusion detection routine for use with high-viscosity formulas and pump 1, such as those shown in FIGS. 1-4 and described above. Most pump-based occlusion detection algorithms use a force sensor to detect an increase in pressure within the tubing, which can indicate an occlusion limiting the flow of enteral nutrients. Due to their high viscosity, normal pumping of thickened enteral formulas and mixed tube feeds often exceeds the force threshold indicating an occlusion in the administration set. Typically, mixed tube feeds are administered via syringe or gravity feed to avoid the use of enteral feeding pumps, which can cause false occlusion alarms. Nurses and / or caregivers can dilute mixed tube feeds with 2-8 oz of fluid before administering them via the administration pump. The addition of this liquid can exceed the patient's food tolerance and limit the patient's ability to receive sufficient calories. Furthermore, pumps and / or administration sets are sometimes modified by nurses and / or caregivers to disable occlusion detection and disable safety features to avoid false alarms.

[0029] In consideration of these known problems described above, to distinguish between thin commercial nutritional formulas that build pressure when an occlusion is present and thicker nutritional formulas that pump normally without an occlusion, method 500 measures pressure decay at the end of an administration cycle. For example, a pressure decay of about 4 pounds per square inch (psi) or greater may indicate that the administration set is not occluded. In another example, a pressure decay of about 3 psi or greater may indicate that the administration set is not occluded. These 3 psi and 4 psi thresholds are examples and depend on the fluid flow rate, e.g., mL / hr. If this decay does not occur at the end of the administration cycle, the relative pressure change of the administration set is evaluated. A relative pressure increase of about 5 psi during the administration cycle may indicate an occlusion. If an administration set is attached to pump 1 with an occlusion present, pump 1 may not sense a significant pressure decay at the end of the delivery cycle and a significant pressure increase during delivery. In this example, force values associated with the last 12 aliquots are evaluated for erratic behavior. While 12 aliquots is an example, any number of aliquots may be averaged. In an occluded administration set, the average change in the magnitude of the force readings obtained after each aliquot delivery is >= 3 PSI. In an unclogged administration set, the force readings obtained per aliquot are more stable. In addition to these basic steps, if fluid is detected with a high-viscosity nutrient solution, as set at installation, the rotor advances 0.5 aliquots before the cassette valve opens. When the valve opens at the start of delivery, residual pressure is released and the administration set returns to a non-pressurized state. This returns a previously used set to baseline conditions, allowing pressure changes to be easily evaluated. Note that the thresholds listed above are for illustrative purposes and are not excluded from this disclosure as a whole, as thresholds may be set based on different factors, such as delivery rate, tubing size, and / or IDDSI level.

[0030] As known in the art, an aliquot is an amount that is an exact divisible amount of the total amount of material. The dosing cycle of X aliquots is determined by time. For example, one dosing cycle is one minute of dosing time. Furthermore, as noted above, the PSI values / thresholds listed above are converted from force readings using calibration constants from the pump.

[0031] Referring to block 502 of the method 500 for occlusion detection for thick nutritional formula administration, a thick nutritional formula cassette is loaded into or onto the pump 1 by a nurse and / or caregiver. At block 504, the system determines whether fluid is present upstream. The pump 1 may be configured to execute a fluid detection routine whereby an ultrasonic sensor is operated to emit an ultrasonic signal through a portion of the tubing to determine the status of the administration set. If the sensor reading exceeds a predetermined threshold, the pump provides an initial indication that fluid is present in the tubing. If the sensor reading is equal to or less than the predetermined threshold, the pump provides an indication that fluid is not present in the tubing.

[0032] If the system determines that no fluid is present in the system, the system opens the valve at block 506. As described with reference to Figures 1-3, valve 12 is where the upstream tubing enters pump 1. Valve 12 closes / opens the lumen of the tubing located within the administration set and is a component of the cassette. The physical opening and closing is accomplished by rotating a mechanical mechanism on the pump that mates with the cassette when attached to pump 1. At block 508, the system primes the cassette. The system may prime the cassette by filling the supply tubing with a portion of the mixed tubing dose. At block 510, the "start" or activation button on pump 1 is pressed by the user. At block 512, the system collects data from the force sensor, as described above. The collected data is referred to as the "A-value." The A-value is the force reading obtained at the beginning of the first administration cycle before the pump is started by the system in a normal aliquot pause administration algorithm. An example of a typical aliquot pause dosing algorithm is disclosed in U.S. Patent Application No. 17 / 750,041, the entire disclosure of which is incorporated herein by reference. Additionally, note that force values are taken as PSI.

[0033] Returning to block 504, if the system determines that fluid is present upstream, the system moves to block 514. In block 514, the rotor advances 0.5 aliquots. In block 510, the "Start" or activation button on Pump 1 is pressed by the user. In block 516, the system opens the valve. In block 518, the system pauses, for example, two seconds, but may be between one and three seconds. During the two-second pause, the pressure in the system stabilizes. In block 520, the system collects data from the force sensor, such as the A value, as described above. In block 522, the rotor advances again 0.5 aliquots to complete the delivery of the first aliquot of thickened enteral formula.

[0034] At block 524, the system steps converge to perform the same steps regardless of the presence or absence of upstream fluid. At block 524, the system executes delivery via an aliquot pause high viscosity nutrient dosing algorithm. As noted above, an example of an aliquot pause dosing algorithm is disclosed in U.S. Patent Application No. 17 / 750,041, the entire disclosure of which is incorporated herein by reference. At block 536, the system collects data from the force sensor, as described above. The L value is a force reading obtained after the final aliquot of the cycle is delivered, but before the intentional pause in the system. At block 528, the intentional pause is, for example, 5 seconds. In another embodiment of the present disclosure, the intentional pause may be between 2 and 7 seconds.

[0035] At block 530, the system collects data from the force sensor, as described above. The C value is a force reading obtained after an intentional pause at the end of the administration cycle. For example, the C value is obtained after a 5-second pause in the system at block 528.

[0036] At block 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 of PSI (X1). The first threshold value may be between -10 PSI and 2 PSI, more specifically between -6 PSI and -2 PSI, and more specifically -4 PSI. If the comparison is yes, the system determines there is no obstruction at block 540. If the result is greater than the first threshold value, the system moves to block 534.

[0037] In block 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 in PSI (X2). The second threshold may be 0-10 PSI, more specifically 4-8 PSI, more specifically 5 PSI. If the comparison is positive, the system is determined to be occluded. In block 538, the system triggers an alarm to notify the nurse / caregiver of the occlusion. In one embodiment of the present disclosure, the alarm may be visual, audible, or a combination thereof. A visual alert may be provided to the user via the display screen 9 (FIG. 1) and / or LED 13, and an audible alert may be provided to the user via a speaker. The alarm may be provided to the user to correct, correct, or adjust the problem with the system. If the result is less than the second threshold, the system moves to block 536.

[0038] At block 536, the system determines whether the average ΔLy is greater than or equal to a third threshold of PSI(X3). The third threshold may be between -6 and 8 PSI, more specifically between -2 and 5 PSI, and even more specifically 3 PSI. Here, ΔLy is the average change in magnitude of the force readings obtained after each aliquot pause between the last two complete rotor revolutions. In one embodiment of the present disclosure, this results in a total of 12 force readings. Note that this value may not include the C value. Furthermore, if the administration rate is less than 21 mL / hr, only 11 force readings may be performed for this calculation. If the comparison is yes, the system determines that an occlusion exists. At block 538, the system triggers an alarm to notify the nurse / caregiver of the occlusion. If the comparison is no, the system determines that no occlusion exists at block 540.

[0039] Additionally, block 536 may be implemented independently or dependently on the downstream occlusion algorithm when pump 1 is operating in bolus max mode. Bolus max mode is when pump 1 is operating at the maximum delivery rate (e.g., 800 mL / hr). Bolus max mode is available when a standard delivery cassette (non-viscous nutritional formula) is loaded into pump 1. When operating in bolus max mode, pump 1 may operate on a 6-minute cycle. Thus, portions of the method and / or system, such as block 536, may be implemented in any pump 1.

[0040] 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 particular tasks or implement particular abstract data types. Aspects of the present disclosure may be implemented using any number and organization of such components or modules. For example, aspects of the present disclosure are not limited to the specific computer-executable instructions or specific components or modules illustrated in the figures and described herein. Other aspects of the present disclosure may include different computer-executable instructions or components having more or less functionality than those illustrated and described.

[0041] Furthermore, the order of execution or performance of operations in the aspects of the present disclosure illustrated and described herein is not required unless otherwise specified. That is, operations may be performed in any order unless otherwise specified, and the aspects of the present disclosure may include more or fewer operations than those disclosed herein. For example, it is contemplated that executing or performing a particular operation before, contemporaneously with, or after another operation is within the scope of the aspects of the present disclosure.

[0042] In operation, the microprocessor 62 executes computer-executable instructions, such as those illustrated in the figures, to implement aspects of the present disclosure. Aspects of the present disclosure may also be practiced in distributed computing environments where tasks are performed by remote processing devices that are linked through a communications network. In a distributed computing environment, program modules may be located in both local and remote computer storage media, including memory storage devices.

[0043] 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 one aspect of the present disclosure, features are directed to one or more computer systems capable of performing the functions described herein. An example of such a computer system 600 is shown in FIG. 6.

[0044] Computer system 600 includes one or more processors, such as processor 604. Processor 604 is connected to a communications infrastructure 606 (e.g., a communications bus, crossover bar, or network). Various software implementations are described in terms of this exemplary computer system. After reading this description, it will become apparent to one skilled in the art how to implement implementations of the present disclosure using other computer systems and / or architectures.

[0045] Computer system 400 may include a display interface 602 that transfers graphics, text, and other data from a communications infrastructure 606 (or from a frame buffer, not shown) for display on a display unit 630. Computer system 600 also includes a main memory 608, preferably random access memory (RAM), and may also include a secondary memory 610. Secondary memory 610 may include, for example, a hard disk drive 612 and / or a removable storage drive 614, representing a floppy disk drive, magnetic tape drive, optical disk drive, Universal Serial Bus (USB) flash drive, etc. Removable storage drive 614 reads from and / or writes to removable storage unit 618 in well-known fashion. Removable storage unit 618 represents a floppy disk, magnetic tape, optical disk, USB flash drive, etc. that is read by removable storage drive 614 and written to removable storage drive 210. As will be appreciated, the removable storage unit 618 includes a computer-usable storage medium having stored thereon computer software and / or data.

[0046] Alternative implementations of the present disclosure may include secondary memory 610 and other similar devices for allowing computer programs or other instructions to be loaded into computer system 600. Such devices may include, for example, removable storage units 622 and interfaces 620. Such examples may include program cartridges and cartridge interfaces (such as those found in video game devices), removable memory chips (such as erasable programmable read-only memories (EPROMs) or programmable read-only memories (PROMs)) and associated sockets, and other removable storage units 622 and interfaces 620 that allow software and data to be transferred from the removable storage units 622 to the computer system 600.

[0047] Computer system 600 may also include a communications interface 624. Communications interface 624 allows software and data to be transferred between computer system 600 and external devices. Examples of communications interface 624 may include a modem, a network interface (such as an Ethernet card), a communications port, a Personal Computer Memory Card International Association (PCMCIA) slot and card, etc. The software and data transferred via communications interface 624 are in the form of signals 628, and signals 310 may be electronic, electromagnetic, optical, or other signals capable of being received by communications interface 624. These signals 628 are provided to communications interface 624 via communications path (e.g., channel) 626. This path 626 carries signals 628 and may be implemented using wire or cable, optical fiber, telephone line, cellular link, radio frequency (RF) link, and / or other communications channels. As used herein, the terms "computer program medium" and "computer usable medium" are used generally to refer to media such as removable storage unit 618, a hard disk installed in hard disk drive 612, and signal 628. These computer program products provide software to computer system 600. Implementations of the present disclosure are directed to such computer program products.

[0048] Computer programs (also called computer control logic) are stored in main memory 608 and / or secondary memory 610. Computer programs may be received via communications interface 624. Such computer programs, when executed, enable computer system 600 to perform features according to implementations of the present disclosure as described herein. In particular, the computer programs, when executed, enable processor 604 to perform features according to embodiments of the present disclosure. Thus, such computer programs represent controllers of computer system 600.

[0049] In aspects in which the present disclosure is implemented using software, the software may be stored on a computer program product and loaded into computer system 600 using removable storage drive 614, hard drive 612, or communications interface 620. The control logic (software), when executed by processor 604, causes 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 application specific integrated circuits (ASICs). Implementation of hardware state machines to perform the functions described herein will be apparent to those skilled in the art.

[0050] FIG. 7 is a block diagram of various exemplary system components according to embodiments of the present disclosure. FIG. 7 illustrates a communication system 700 including one or more accessors 760 (also referred to herein as one or more “users”), one or more terminals 742. The terminals 742 may include systems 100 and / or 200, or related systems, described above, or the like. In one embodiment, data for use in accordance with embodiments described herein may be entered and / or accessed by the accessors 760 via terminals 742, such as personal digital assistants (“PDAs”) and RFID readers (e.g., handheld, mobile, cabinet, etc.), coupled to a server 743, such as a PC, minicomputer, mainframe computer, microcomputer, telephone device, or other device having a processor and a repository of data and / or connecting to a repository of data, via 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 exemplary variation, methods and systems according to aspects described herein operate in a standalone environment, such as on a single terminal.

[0051] Aspects described herein may also be described and implemented in the context of a computer-readable storage medium that stores computer-executable instructions. Computer-readable storage media include computer storage media and communication media, and may be flash memory drives, digital versatile disks (DVDs), compact disks (CDs), floppy disks, and tape cassettes. Computer-readable storage media may include volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer-readable instructions, data structures, modules, or other data.

[0052] 8A-8N, exemplary results associated with an occlusion detection routine according to one embodiment of the present disclosure are shown, which are exemplary results illustrating the steps taken to determine the threshold determined and implemented in block 500 of FIG.

[0053] Referring to FIG. 8A, as described above, interval plot changes during pump pauses are shown. In particular, the graphs show the difference in behavior over time during periods of pump inactivity between various mixed / high-viscosity formulas, occluded and non-occluded administration sets, with IDDSI levels 2-4. The graphs show the change in pressure (psi) from time zero (L), when the last aliquot was delivered in a given administration cycle, to the elapsed time shown on the x-axis. This average demonstrates that non-occluded administration sets provide a pressure drop during periods of inactivity that is not observed with occluded sets. Note that there is some overlap in the highlighted distributions.

[0054] Referring to Figure 8B, a second interval plot of changes during pump pauses, as described above, is shown. This graph shows the unoccluded administration sets from the graph of Figure 8A, but separated by formula type. In particular, this graph shows that mixed, generally more viscous formulas (e.g., IDDSI Level 4) exhibit a more significant pressure drop during periods of pump inactivity compared to more homogenous, generally less viscous formulas (e.g., IDDSI Level 2).

[0055] Referring to FIG. 8C, the distribution of unoccluded mixed formula and occluded formula is shown. Specifically, the graph shows a histogram of pressure change during a 5-second pause period (pump inactivity) from the time the last aliquot was delivered in an administration cycle, comparing occluded administration sets (all formula types) with occluded mixed formula. The graph demonstrates that there is a separation in the distribution, thereby allowing a threshold to be established. In particular, this graph provides the basis for how the first part of the occlusion detection algorithm for high viscosity formula (as described above with reference to block 532 of FIG. 5) was derived, where the L value is the force reading obtained after the last aliquot of the administration cycle is delivered, and the C value is the force reading obtained after the intentional 5-second pause. As described above, if this criterion is met, the system can determine that the administration set is not occluded.

[0056] Referring to FIG. 8D, a histogram of C minus A values for both occluded and non-occluded homogeneous formula is shown. This graph illustrates the absence of a pressure drop during the 5-second pause after the last aliquot is delivered in a dosing cycle. Specifically, this graph demonstrates that there is a clear pressure increase only in the occluded set, as measured from the beginning of the first dosing cycle before pumping (value A) to 5 seconds after pumping in a given dosing cycle (value C). Furthermore, there is a separation of the distributions that allows a threshold to be established. Specifically, this graph provides the basis for how the second criterion of the occlusion detection algorithm for viscous formulas was derived (as described above with reference to block 534 of FIG. 5): (CA) >= 5 psi.

[0057] Referring to Figure 8E, a flowchart / algorithm determined based on the data interpreted by Figures 8A-8D is shown schematically. The accuracy of the algorithm in Figure 8E was tested using a high viscosity mixed formula (IDDSI4) and water (IDDSI0) using various nasogastric tube sizes at various administration rates. The results of this test for normal conditions are shown in Figure 8F, described below. The normal conditions indicate that an unoccluded administration set was loaded into the pump, the administration set was then primed, and feeding was initiated without issue, and an occlusion was simulated during a normal feeding by clamping the administration set. The conditions shown in Figure 8F were sufficient to detect an occlusion during these use conditions.

[0058] The accuracy of the algorithm in Figure 8E was tested using a high viscosity mixed formula (IDDSI4) and water (IDDSI0) using various nasogastric tube sizes at various administration rates. The results of this test for a non-normal condition are shown in Figure 8G. A non-normal condition occurs when an occluded set is loaded into the pump before feeding begins. The criteria shown in Figure 8G were not sufficient to detect an occlusion during this use condition.

[0059] Referring to Figure 8H, when observing force readings (as measured using analog-to-digital conversion, ADC, e.g., digital values proportional to analog readings) over time, as illustrated by the time-lapse sequence by aliquot, there was a more erratic and noisy pressure profile evident in the occluded administration set than in the non-occluded administration set. This erratic behavior was quantified by taking the average change in magnitude from aliquot to aliquot for the last two rotor revolutions (12 aliquots). The absolute value of the point-to-point force difference was 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 -FL-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). Standard deviation for assessing noise in the pressure response is not required to characterize noise relative to the mean, but may be implemented in the system / method. For example, standard deviation may be implemented to further quantify trends and / or behavior in any of the pressure signal readings.

[0060] Referring to Figure 8I, the average change in pressure magnitude from aliquot to aliquot for the last two rotor revolutions between occlusion and non-occlusion is shown. Specifically, an occluded administration set (a non-normal condition as described and illustrated in connection with Figure 8G and shown in this graph as high pressure vs. high pressure, or H2H) was compared to an occluded administration set (in this case shown as low pressure vs. low pressure, L2L). Figure 8I shows plots of individual values for this data using six pumps: four different nutrient types, and two different administration rates. Figures 8J-8L show the same data, but categorized by pump, nutrient type, and administration rate, respectively.

[0061] Referring to Figure 8M, there is shown the final flow chart illustrating the decision tree for the blockage detection algorithm for a viscous nutritional formula after considering Figures 8A-8L as described above. For reference, and as described above, the C force value is taken at the end of the 1-minute cycle, 5 seconds after the last aliquot is delivered. The L force value is taken after the last aliquot is delivered. The A force value is taken at the start of dosing, just before the first aliquot is delivered. Avg(ΔL12) is the average change in magnitude from aliquot to aliquot for the last two rotor revolutions.

[0062] Referring to Figure 8N, test results of the flowchart from Figure 8M are shown using the various pumps, dosing rates, formulation types, and use conditions under test. 99.4% of occlusions were detected after three 1-minute dosing cycles, with only 0.05% resulting in false alarms. These results are a significant improvement over systems that do not use an algorithm.

[0063] While the embodiments described herein are described in conjunction with the exemplary embodiments outlined above, various alternatives, modifications, variations, improvements, and / or substantial equivalents, whether known or not currently foreseen or may not be foreseen, may become apparent to at least those skilled in the art. Accordingly, the exemplary embodiments described above are intended to be illustrative and not limiting. Various changes may be made without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to embrace all known or later-developed alternatives, modifications, variations, improvements, and / or substantial equivalents.

[0064] Accordingly, the scope of the claims is not intended to be limited to the embodiments set forth herein but is to be accorded the full scope consistent with the language of the claims, and reference to an element in the singular is not intended to mean "one and only one," unless specifically so stated, but rather "one or more." All structural and functional equivalents to the elements of the various embodiments described throughout this disclosure that are known or later become known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase "means for."

[0065] It is understood that the specific order or hierarchy of the processes / flowcharts disclosed is an example of a sample approach. Based on design preferences, it is understood that the specific order or hierarchy of the processes / flowcharts may be rearranged. Additionally, some features / steps may be combined or omitted. The accompanying method claims present elements of the various features / steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0066] Furthermore, any aspect described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects. Unless otherwise specified, 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 multiples of A, multiples of B, or multiples of C. In particular, 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 A only, B only, C only, A and B, A and C, B and C, or A and B and C, and any such combination may include one or more members of A, B, or C. Nothing disclosed herein is intended to be made public, regardless of whether such disclosure is expressly recited in the claims.

Claims

1. 1. A method for detecting occlusion in a dose pump, comprising: determining when an administration set containing a liquid is engaged with the administration pump, the liquid being a nutritional formula; advancing a first amount of the nutrient through the administration pump and via a nutrient conduit, the first amount being a first volume of the liquid; obtaining a reading of a first pressure sensor in the administered nutritional formula conduit; advancing a second amount of the nutrient dosage through the dosage pump and via the nutrient dosage conduit, the second amount being a second volume of the liquid; obtaining a second pressure sensor reading of the administered nutritional formula conduit; obtaining a third pressure sensor reading of the administered nutritional formula conduit; and detecting when an occlusion is present in the administered nutrient conduit based on at least one of the first pressure sensor reading, the second pressure sensor reading, and the third pressure sensor reading.

2. 10. The method of claim 1, wherein the administered nutritional formula is rated as Level 0-4 on the International Dysphagia Diet Standardization Initiative (IDDSI) framework.

3. 3. The method of claim 2, wherein the administered nutritional supplement is further rated as Level 2-4 on the IDDSI framework.

4. 10. The method of claim 1, further comprising pausing the administration pump for a predetermined period of time after advancing the first amount of the administered nutritional formula and before obtaining a reading of the first pressure sensor.

5. The method of claim 4, wherein the predetermined period is between 1 and 3 seconds.

6. 5. The method of claim 4, further comprising pausing the administration pump for a second predetermined period of time after advancing the second amount of the administered nutritional formula and before obtaining the third pressure sensor reading.

7. 7. The method of claim 6, wherein pausing the dose pump for the second predetermined period occurs after performing obtaining the second pressure sensor reading.

8. The method of claim 6, wherein the second predetermined period is between 2 and 7 seconds.

9. 10. The method of claim 1, further comprising pausing the administration pump for a predetermined period of time after advancing the second amount of the administered nutritional formula and before obtaining a third pressure sensor reading.

10. 10. The method of claim 9, wherein pausing the dose pump for the predetermined period occurs after taking the second pressure sensor reading.

11. The method of claim 10, wherein the predetermined period is between 2 and 7 seconds.

12. 10. The method of claim 1, wherein the administered nutritional formula conduit is a tube pressurably engaged with a rotor of an administration set.

13. 10. The method of claim 1, wherein the first volume of liquid and the second volume of liquid are one aliquot.

14. 10. The method of claim 1, wherein advancing the first amount primes the administration set.

15. 10. The method of claim 1, further comprising determining that the administered nutrient conduit is not obstructed when the difference between the reading of the third pressure sensor and the reading of the second pressure sensor is less than or equal to X pounds per square inch (PSI).

16. When the difference between the reading of the third pressure sensor and the reading of the second pressure sensor is greater than X pounds per square inch, and when the difference between the reading of the third pressure sensor and the reading of the first pressure sensor is X pounds per square inch, ２ 10. The method of claim 1, further comprising: the administered nutrient conduit being blocked when the nutrient supply is below 100 psi.

17. When the difference between the reading of the third pressure sensor and the reading of the second pressure sensor is greater than X PSI, the difference between the reading of the third pressure sensor and the reading of the first pressure sensor is X ２ PSI and the average of multiple previous second pressure sensor readings is X ３ 10. The method of claim 1, further comprising: when the administered nutrient conduit is occluded.

18. X is between -10 and 2 PSI, and X ２ is between 0 and 10 PSI, and X ３ 18. The method of claim 17, wherein the pressure is between -6 and 8 PSI.

19. X is between -6 and -2 PSI, and X ２ is between 4 and 8 PSI, and X ３ 19. The method of claim 18, wherein the pressure is between -2 and 5 PSI.

20. X is -4 PSI, and X ２ is 5 PSI, and X ３ 20. The method of claim 19, wherein the pressure is 3 PSI.

21. 18. The method of claim 17, wherein the plurality of previous second pressure sensor readings are pressure readings for 12 seconds or less.

22. 1. A dose pump configured for occlusion detection, comprising: one or more memories; one or more processors coupled to the one or more memories, individually or in combination: determining when an administration set containing a liquid is engaged with the administration pump, the liquid being a nutritional formula; advancing a first amount of the nutrient dosage through the dosage pump and via a nutrient dosage conduit, the first amount being a first volume of the liquid; obtaining a first pressure sensor reading of the administered nutritional formula conduit; advancing a second amount of the nutrient dosage through the dosage pump and via the nutrient dosage conduit, the second amount being a second volume of the liquid; obtaining a second pressure sensor reading in the administered nutritional formula conduit; obtaining a third pressure sensor reading in the administered nutrient conduit; and one or more processors configured to detect when an occlusion exists in the administered nutrient conduit based on at least one of a reading of the first pressure sensor, a reading of the second pressure sensor, and a reading of the third pressure sensor.

23. 1. A computer-readable medium comprising stored instructions for occlusion detection, the instructions being executable by one or more processors and comprising, individually or in combination: determining when an administration set containing a liquid is engaged with the administration pump, the liquid being a nutritional formula; advancing a first amount of the nutrient dosage through the dosage pump and via a nutrient dosage conduit, the first amount being a first volume of the liquid; obtaining a first pressure sensor reading of the administered nutritional formula conduit; advancing a second amount of the nutrient dosage through the dosage pump and via the nutrient dosage conduit, the second amount being a second volume of the liquid; obtaining a second pressure sensor reading in the administered nutritional formula conduit; obtaining a third pressure sensor reading in the administered nutrient conduit; A computer-readable medium for detecting when an occlusion exists in the administered nutritional formula conduit based on at least one of a reading of the first pressure sensor, a reading of the second pressure sensor, and a reading of the third pressure sensor.

24. 1. An administration set configured for administration pump occlusion detection, comprising: a liquid, the liquid being a nutrient; and a nutrient administration conduit, wherein the administration pump is configured to advance a first amount of the nutrient administration through the nutrient administration conduit, the first amount being a first volume of the liquid; The dosing pump comprises: obtaining a first pressure sensor reading of the administered nutritional formula conduit; advancing a second amount of the nutrient dosage through the dosage pump and via the nutrient dosage conduit, the second amount being a second volume of the liquid; obtaining a second pressure sensor reading in the administered nutritional formula conduit; obtaining a third pressure sensor reading in the administered nutrient conduit; the administration set is further configured to detect when an occlusion is present in the administered nutrient conduit based on at least one of a reading of the first pressure sensor, a reading of the second pressure sensor, and a reading of the third pressure sensor.

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