JPWO2021137903A5 - - Google Patents

Description

TECHNICAL FIELD The present invention relates generally to sensors for instruction compliance systems.

Infusion systems allow patients to continue their medical treatment at home or at a remote location after being discharged from a medical facility such as a hospital. Such systems facilitate slow and steady flow of drug into the patient. A treatment plan may require continuous, periodic treatment over a period of time to completely treat symptoms. However, patients do not always follow prescribed treatment plans, and some may refuse their treatment altogether. If a compliance visit is expected, some patients may even throw away medication to disguise compliance. Patients who do not comply with such instructions are more likely to result in poor health outcomes, including amputation, readmission, and even death.

Infusion therapy may use electronic infusion pumps (ie, pumps that operate based on electric motors or drivers) or mechanical infusion pumps (ie, pumps that use non-electrical mechanical forces). Many hospitals and medical facilities use electronic infusion pumps, while many remote or home treatments use mechanical infusion pumps, such as elastomeric ball pumps. Elastomeric pumps are driven by elasticity in the container and include a flow regulating valve, such as a steel cannula, to control the flow to the patient.

Electronic infusion pumps, including portable ones, may include a heating mechanism to increase the temperature of drugs or infusion fluids stored in cold storage. Managing the temperature of fluids to the patient is important for patient comfort and to avoid possible adverse physiological effects due to the introduction of cold fluids.

In mechanical infusion pumps, the pump containing the infusion fluid is typically set for a given period of time to allow the fluid temperature to rise toward room temperature. After the set time has elapsed, the mechanical infusion pump is connected to the patient line and treatment begins.

Since some patients do not follow treatment plans, a compliance protocol can be implemented for patient-administered treatment at a remote location or at home. Compliance benefits the patient and also benefits hospitals, payers, insurance companies, Medicare, etc. by reducing the likelihood of recurrence or even death.

Some portable electronic infusion pumps have electronic data logging mechanisms to record treatments. These data log records may be recorded on an electronic memory device and collected periodically when the patient is at the medical facility or when a traveling clinician visits the patient. Some electronic pumps may include computer connections or communication components to send data logging to a database. These devices may also include heating components, pressure sensors, and regulatory systems to prevent improper delivery.

Unlike electronic pumps, mechanical infusion pumps do not have data logging capabilities or integrated systems to ensure that therapy is being administered properly. These pumps are typically disposable pumps that are disposed of by the person after use. As such, compliance often requires someone to visit a remote location or home to monitor treatment or check stored medication to ensure the correct amount is left. This leaves many loopholes for non-compliance that cannot be accurately ascertained, such as whether the patient is administering the treatment properly at the right time and in the right manner, or whether the patient is discarding the medication. .

US Patent Application Publication No. 2011/0224603 discloses a pressure sensor device for detecting the flow rate through a series connection and/or whether there is a blockage in a tube. In this device, pressure sensors are placed around a restriction applied to fluid flow.

US Patent Application Publication No. 2011/0224603

The present disclosure teaches an Infusion Monitoring Device (IMD) and a patient instruction compliance system for an infusion pump. The instruction compliance system works with all infusion pumps, including mechanical infusion pumps such as elastomeric ball pumps. Because the IMD is infusion pump agnostic, it provides a compliance test aid applicable to remote and home infusion environments that previously did not have a compliance test aid option available. IMDs also address the psychological effects associated with loneliness, which can lead to noncompliance, for example, when patients believe that no one cares about whether they are taking their medication because they are alone. can be reduced. In some embodiments, the IMD communicates with the patient's social and clinical support organizations.

In some embodiments, the IMD includes a housing having a foldable cap that is biased to a closed position, with the foldable cap abutting a side of the housing. Examples may include a spring, elastic body, or other biasing mechanism connecting the collapsible cap to the housing. The collapsible cap and the abutting sides of the housing may define a tunnel or passageway into which the tube is fitted. Embodiments may include corresponding channels in the collapsible cap and the sides of the housing, which together form a tube tunnel. When used in a compliance system, the tunnel may fit around the infusion pump tubing and retain the sensor to the tubing.

In some examples, the housing includes flow sensors (e.g., temperature sensors, bubble sensors, pressure sensors, etc.), control electronics (e.g., microprocessors, central processing units, microcontrollers, etc.), communication components (e.g., cellular chips, Wi-Fi chips, etc.), memory, and power supplies. In some examples, a location component (eg, a Global Positioning System (GPS) module, a LORAN module, etc.) may be included. In some examples, an IMD may include a control interface, such as a switch or button, for a user to control the device. Some examples may include lights, displays, speakers, or other outputs that provide operational feedback to the user.

In some examples, a temperature sensor may be positioned within or against the tunnel to measure the temperature of the tube. Temperature sensors measure temperature periodically or provide constant temperature information. Temperature information may be stored in memory. In some examples, temperature information may be sent to other system components via the communication component, either directly or indirectly via stored memory.

In some embodiments, the IMD is attached to tubing extending from a mechanical infusion pump. To attach the IMD to the tube, the collapsible cap is opened, the tube is placed in the channel on the side of the housing, and then the collapsible cap is closed onto the tube. The IMD may measure the temperature of the tube, etc. In some examples, a temperature sensor or control electronics may be configured to determine the temperature of the fluid within the tube.

In some examples, the IMD may include a connector or latch that holds the collapsible cap against the housing. Connectors may include snap-fits, buttons, friction connectors or other connector components. In some embodiments, the IMD includes a release device that disengages the connector. In some examples, a separate sensor may determine whether the connector is engaged or disengaged.

IMD embodiments may include additional sensors to initiate operation. In some examples, the engagement sensor may initiate the monitoring process when the IMD is connected to the tube. An inertial measurement unit may be included to initiate the process when the IMD is moved. In rechargeable embodiments, the IMD may include a charging sensor and initiate the process when the charging connection is disengaged.

In some embodiments, the IMD is a mechanism for an instruction compliance system. The directive compliance system may include an IMD, a communication network, a cloud system, and a monitoring system having a directive compliance database that receives and stores directive compliance information from the IMD.

In some examples, the instruction compliance database may also receive a patient treatment plan corresponding to the IMD. The system may use anonymized data to link the treatment plan with compliance information from the IMD. In some embodiments, the monitoring system includes a computer, such as an analysis system, that determines whether the received compliance information is in accordance with the expected treatment from the treatment plan.

In some examples, the system may also include a user device for the patient or other designated person, such as the patient's physician, agent, surrogate, or decision maker. In the event that a compliance discrepancy is identified, the computer or compliance database may send a communication to the patient or the patient's designee. In some embodiments, the system may be designed to send a reminder message in advance of any compliance-related matter.

In some examples, a communication module of the IMD may be configured to receive signals from the system. The IMD may also provide output to the patient based on system signals such as reminder lights, acoustic beeps, or vibration alerts. In some examples, the IMD may include a display that displays stored messages corresponding to instruction compliance notifications and reminders. In other examples, compliance notifications and reminders may be sent to the user's mobile phone for display.

In some embodiments of the compliance system, a patient removes a mechanical infusion pump containing an infusion fluid, such as a drug, insulin, or antibiotic, from cold storage and attaches an IMD to the infusion pump tubing. Once the IMD is attached, the IMD may begin sensing the temperature of the tube automatically or based on user selection. The patient then leaves the pump and IMD in place for a predetermined period of time while the fluid temperature increases toward room temperature. While standing, the IMD continues to sense temperature and store or transmit readings.

Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: FIG.

1 is an example of an infusion pump and an infusion monitoring device. 1 is an example of an infusion pump and an infusion monitoring device. 1 is an example of an infusion monitoring device. FIG. 2 is a block diagram of an example of an infusion monitoring device. 1 is an example of an instruction compliance system having an infusion monitoring device. 2 is another example of an infusion monitoring device.

Although the invention may be embodied in many different forms, this disclosure is to be considered as an exemplification of the principles of the invention, and it is not intended to limit the broad aspects of the invention to the examples shown. Preferred embodiments of the invention are described in detail herein with the understanding that the invention is not intended to be exhaustive. It will be understood that the invention may be embodied in other specific forms without departing from its spirit or central characteristics. Accordingly, this example is to be considered in all respects as illustrative and not restrictive, and the invention is not to be limited to the details provided herein.

In the context of the examples provided, the device is referred to as an "infusion monitoring device." Those skilled in the art will appreciate that the device taught is a tube monitoring device that can be used in additional environments and contexts.

FIG. 1A shows an infusion monitoring device (IMD) 102 attached to a tube 106 extending from an infusion pump 104. Infusion pump 104 in this example is shown as an elastomeric ball infusion pump that uses pressure created by elastic forces to move medication or other infusion fluid through tube 106. Elastomeric ball infusion pumps are an example of mechanical infusion pumps. Those skilled in the art will recognize that IMD 102 may be used with other infusion pumps. Additionally, IMD 102 may be attached to tubing 106 extending from other infusion pumps, fluid delivery systems, or other components.

IMD 102 includes a main body or housing 110 and a slidable cap 112. The sides of the housing 110 and the slidable cap 112 include corresponding channels that form a tunnel 116 when the slidable cap 112 is closed relative to the housing 110. In other examples, alternative movable cap configurations for the slidable cap 112 may be used to allow for open and closed positions, such as a hinged cap. Tunnel 116 fits around tube 106 and attaches IMD 102 to tube 106. Cap controller 114 allows a user to move slidable cap 112 to an open position to fit tube 106 into place.

FIG. 1B illustrates the IMD 102 with the cap controller 114 moved to the second position to place the slidable cap 112 in the open configuration. In this open configuration, IMD 102 may be connected to or removed from tube 106.

In this example, IMD 102 includes a switch 118 on main housing 110. Switch 118 may be used as a controller to power on and off IMD 102 . Other embodiments may be configured to automatically power on and off based on movement or operation of the IMD 102. For example, IMD 102 may be powered on to begin the monitoring process when slidable cap 112 is opened and then closed by cap controller 114. In such illustrative examples, IMD 102 may include a sensor or other component within or adjacent tunnel 116 to determine whether tube 106 is present within tunnel 116. If tube 106 is present, IMD 102 is powered on. Conversely, when tube 106 is not present, IMD 102 may be powered off or may remain off.

FIG. 2 shows an alternative embodiment of an infusion monitoring device 200. Similar to IMD 102, this embodiment includes a body portion 210 and a hinged cap 212. IMD 200 is illustrated in an open configuration with hinged cap 212 attached to body portion 210 at joint 216. Joint 216 may be a hinged connection that joins two parts together. Alternatively, the body portion 210 and the hinged cap 212 may be made integrally with a joint 216 configured to allow the hinged cap 212 to flex between open and closed positions. For example, joint 216 may have a thinner plastic or polymer portion than the housing. Thinner sections may allow bending or bending.

In some examples, joint 216 may include a spring or other resilient component that biases hinged cap 212 into a closed position against a side of body portion 210. IMD 200 may include a latch, clip, or other mechanism to hold hinged cap 212 in place when it is in the closed position.

IMD 200 also includes buttons 214 to control IMD 200. In some examples, button 214 may control a latching mechanism that releases hinged cap 212 from body portion 210 to remove or connect IMD 200 from tube 106. Alternatively, button 214 may be used to select an action or provide system feedback.

A housing channel 222 is located on the side of the housing 210 and a cap channel 220 is located within the hinged cap 212. When housing 210 and hinged cap 212 are in the closed configuration, housing channel 222 and cap channel 220 align to create a tunnel. During operation of IMD 200, the tube is retained within this tunnel.

IMD 200 includes a sensor that measures tube information. For example, IMD 200 may include a temperature sensor to determine tube temperature. Additional sensors may be present within the housing 210 having sensing surfaces within or relative to the housing channel 222. For example, a flow sensor may be directed into the tunnel. In some examples, a sensor may direct a sensing mechanism, such as a lens of an optical sensor, into the housing channel 222.

In this example, IMD 200 includes a series of lights, such as light emitting diodes (LEDs) 226. These may be individual LEDs or an LED array. The LEDs 226 may each have a defined color, or the one or more LEDs 226 may be RGB (red, green, blue) LEDs allowing each LED to indicate multiple color options. good. Additionally, the LEDs 226 can each be configured to provide alternative display options, such as fading in and out, flashing, and the like. In conjunction with this, LED 226 may provide a cooperative display. For example, each LED may dim one by one after all four are lit.

LED 226 may be used to indicate the status of IMD 200. For example, one LED 226 may indicate the operational status of the device (eg, active or inactive). Another LED 226 may indicate battery status (eg, green for full charge, yellow for low charge, red for nearly empty). A third LED 226 may indicate data storage activity (eg, a light may be on when logging data to onboard memory). Finally, a fourth LED 226 may indicate communication status (eg, a blue light may indicate that communication with a networked system is in progress).

IMD 200 also includes buttons 230 and 232. These may be used for user control or information gathering. For example, a user can press button 230 to indicate that the user is in a happy or positive mood, or press button 232 to indicate that the user is in a sad or negative mood. . In some examples, the number of times buttons 230 and 232 are pressed may indicate the level of happiness or sadness that the user is currently feeling. For example, a user may press button 230 three times to indicate that the user is having a lot of fun. Alternatively, the user may press button 232 once to indicate that they are feeling a little depressed. IMD 200 may prompt the user to select options at various times during treatment. For example, buttons 230 and 232 may flash when IMD 200 is attached to a tube, when a user initiates therapy, and when a user completes therapy.

FIG. 3 provides a block diagram of an infusion monitoring device 300. In this embodiment, the IMD 300 includes a central processing unit (CPU) 302, a memory 304, a power supply 306, a communication circuit 308, and a Global Positioning Satellite System (GPS) receiver 310. , a temperature sensor 312 , a temperature sensor 314 , a removable memory 316 , and a user interface 318 .

Embodiments may also include alternative or additional components. For example, IMD 300 may include a pressure sensor to determine if IMD 300 is connected to a tube. A pressure sensor may also be included to determine if the pressure within the tube has changed. Additionally, the tube sensor may include a bubble sensor that determines whether a bubble has passed through the tube. A flow sensor may be used to determine whether fluid is flowing through the tube.

Control circuit 302 is illustrated as a CPU and may be a microprocessor, microcontroller, programmable integrated circuit, or other computer chip. Control circuit 302 is programmed or configured to access a program with operating instructions. In some embodiments, control circuit 302 may include an integrated memory component having an operating program. Control circuit 302 is connected to memory 304, which may store data logging instructions, analysis instructions, instruction compliance criteria, and data acquired by sensors in IMD 300. Control circuit 302 may be directly wired to memory 304 or may be indirectly connected through a bus or another component. Control circuit 302 is also connected directly or indirectly to communication circuit 308, GPS receiver 310, temperature sensors 312 and 314, and user interface 318.

In some embodiments, in addition to memory 304, IMD 300 also includes removable memory 316, such as an SD card. In some embodiments, memory 304 may be on-board memory for operational instructions, and removable memory 316 may contain sensor information, user interface information, and any additional device logging data. may receive and store data acquired during operations such as; In such embodiments, IMD 300 may be returned to the facility and removable memory 316 may be removed and replaced with new removable memory 316. The IMD 300 with new removable memory can be sent to another user without any risk of user data being communicated. In some embodiments, IMD 300 may include only one form of memory: memory 304 or removable memory 316. In other embodiments, IMD 300 may include multiple memory components. Memory 304 and removable memory 316 may be random access memory, read-only memory, programmable read-only memory, programmable read/write memory, solid state memory, or any other type of memory.

A power supply 306 is also included to provide power to each component in the IMD. Power source 306 may be a battery, such as a lithium-ion coin cell or another power storage component.

Communication circuitry 308 collectively refers to communication structures such as communication chips and antennas. In this example, communications circuitry 308 is shown as a cellular communications chip. Examples of communication modules 308 include BLUETOOTH communication modules, Wi-Fi communication modules, cellular communication modules, and other communication network modules. In this example, communication circuit 308 may be a cellular network card that provides communication over a cellular network.

In this embodiment, IMD 300 includes a GPS receiver 310, which determines the location of IMD 300. Other embodiments may use alternative location determination circuits or systems. For example, the communication system may be used to locate the IMD 300 through a number of known techniques, such as triangulation from or to a known location. A local receiver or structural component for a location system within a device may be referred to as a location receiver.

The IMD 300 includes two temperature sensors 312 and 314 that are spaced apart along a channel or tunnel of the IMD 300. Temperature sensors 312 and 314 may be any type of contact or non-contact thermometer operable to measure temperature, such as thermometers, thermistors, thermocouples, resistance temperature detectors, and semiconductor-based temperature sensors. good. In some embodiments, temperature sensors 312 and 314 are the same type of sensor. In other embodiments, temperature sensors 312 and 314 are different sensor types.

When IMD 300 is attached to the tube, temperature sensors 312 and 314 periodically acquire temperature and sensor data is recorded in memory 304. In some embodiments, temperature sensors 312 and 314 incorporate hardware, firmware, or software that converts sensed information to a temperature output before the sensor data is stored in memory 304. In other embodiments, temperature conversion may be performed within control circuit 302. In yet other embodiments, the recorded data (such as current or voltage) is maintained and the temperature gradient analysis uses the recorded data without converting it to a temperature output.

User interface 318 on IMD 300 may be any type of user interface, such as one or more buttons, switches, touch screen controls, knobs, voice-activated controls, etc. User interface 318 may include input and output components. Output components may include visual outputs such as lights and displays, audio outputs, tactile outputs, vibrational outputs, or other outputs that communicate information to a user. In some embodiments, user interface 318 may be supported through communication circuitry 308. For example, a user may provide input through a telephone application. These inputs may be sent from the telephone to the communications circuitry 308 of the IMD 300. Additionally, communication circuit 308 may send output to the user's phone. For example, communication circuit 308 may send an alert that IMD 300 has been attached to a tube. IMD 300 may then send a notification to the user's phone when temperature sensors 312 and 314 indicate the drug is ready for administration.

User interface 318 may be used for user input for operational control or information gathering. Examples of operational controls include on/off control, start/stop control, communication control, timer control, or any other control for the operation of IMD 300. Options for information gathering may include input controls that allow the user to provide identification data, social information (such as mood information), or other data separate from the operation of the IMD 300.

FIG. 4 shows a networked system for IMD 102 attached to infusion pump 104. In addition to IMD 102, the illustrated system includes a network 402, a database 404, an instruction compliance computer 406, and a mobile device 408. IMD 102 includes communication components that communicate with network 402 . This communication may be a direct connection, such as a cellular connection to the Internet, or an indirect connection, such as a WIFI connection to a networked router that provides access to the Internet.

Network 402 may be any type of network that facilitates telecommunications. For example, network 402 may be the Internet. In some embodiments, network 402 is integrated with database 404 as part of a larger cloud-based network that houses and aggregates data. In some embodiments, database 404 may be independent of larger network 402, or database 404 may include a portion within network 402 and a portion of a stand-alone server or computer location.

Instruction compliance computer 406 may be a smart phone, laptop, desktop, tablet, or other computer. Instruction compliance computer 406 evaluates data from database 404 to determine whether the user has properly administered his or her medication. In addition to the instruction compliance evaluation, the instruction compliance computer 406 may also evaluate data for other information. For example, the compliance computer may evaluate social indicators received from the user of the IMD 102 to determine whether the individual's indicated mood is associated with compliance with the treatment plan instructions. These social indicators can also influence whether a personal visit, phone call, or correspondence can be scheduled to address matters unrelated to compliance.

Mobile device 408 may be any type of mobile device such as a smart phone, tablet, laptop computer, etc. Mobile device 408 may be any device used to communicate with a patient, a patient's clinician, a personal representative, or a representative of the patient's medication. The user's mobile device 408 may receive notifications, reminders, or other information from the database reflecting the user's compliance with the instructions. For example, when the compliance computer 406 sends confirmation to the database 404 that the user has properly administered the treatment, the database 404 may send a positive feedback response to the mobile device 408 to promote successful treatment. In some examples, database 404 may have a trigger to send a reminder when a specified amount of time has elapsed after the first treatment. For example, the database 404 may send a reminder to the mobile device 408 to retrieve the next infusion pump 104 and attach the IMD 102 eight hours after the morning treatment.

Those skilled in the art will recognize that this is an example of a networked system. The system may be implemented with other networks, connection points, components and configurations. For example, the system may be built in a cloud environment with network 402, database 404, and instruction compliance computer 406 as integrated components. The system may automatically aggregate data received from the IMD 102 into a cloud database 404 and perform instruction compliance checks through a cloud-based instruction compliance computer 406. Following the instruction compliance check, the system may send a notification or other output to the mobile device 408.

Once a patient is discharged from a medical facility for remote administration of medications, the patient may be referred to home infusions. The home infusion provider seeks approval from the payer and registers the necessary data for the compliance system database 404.

The data includes the medical treatment plan for the patient, such as drug type and amount, treatment duration and schedule, as well as contact information of the user, clinician, home infusion provider, representative, or other authority for house calls. Contains holder contact information. Those skilled in the art will appreciate that other information may be required for the particular situation, such as individual medical dosing guidelines, drug summaries, customized adjustments for treatment plans, social analysis baseline information, and other information. Let's be aware of that. Data may be stored and organized within database 404.

In some embodiments, this data may be encrypted and anonymized to a degree that allows for protection of patient data. In some examples, patient identification information may be maintained in the home infusion provider's database and made available only when a notification is sent. In such cases, the data required by the assigned IMD 102, treatment plan, and instruction compliance system may be associated with a secure identifier that is independent of personal information.

Upon receiving the IMD 102 request and related data, the instruction compliance service assigns the IMD 102 a unique identifier for all instruction compliance checks and sends the IMD 102 with instructional information for using the IMD 102. In some examples, the instruction compliance service may have the number of the user's mobile device 408 and may send instructional information to the user via the mobile device 408. This process may include requesting any additional information to set up an account. In some situations, a home infusion supplier or instructional compliance service may deliver the IMD 102 with an initial application that teaches or demonstrates how to use the IMD 102 and infusion pump 104.

To use IMD 102, a patient may remove infusion pump 104 from the freezing or cooling device and attach IMD 102 to tubing 106 extending from infusion pump 104. For example, cap 112 is opened, tube 106 is placed within the channel forming tunnel 116, and then cap 112 is closed. In some examples, IMD 102 may include a verification component such as a camera, a wireless tag reader, an optical reader, or other verification mechanism. For example, a camera may be used to verify that the patient has selected the correct medication, such as by taking an image of the infusion pump 104. As another example, a camera may be used to read the medication code on the infusion pump 104 and provide an output indicating that the medication is compatible with the patient's treatment plan. The matching component may be constructed anywhere outwardly facing within the housing of the IMD 102. In some examples, a verification component may be present on the top of the IMD 102 and a patient code may be attached to the bottom of the infusion pump 104. Once the IMD 102 is properly attached to the tube, the verification component can read the patient code to confirm the appropriate medication for treatment. Matching information may be sent to network 402 and stored in database 404.

Once IMD 102 is attached to tube 106, IMD 102 may begin measuring the temperature of tube 106. IMD 102 may also remember the start time of when IMD 102 was attached to the tube. In other examples, the IMD 102 may begin measuring temperature when the cap 112 is opened to first determine the ambient room temperature.

IMD 102 continues to measure tube temperature at a given test rate, such as every 3 milliseconds, every second, three times a minute, or any other rate. The default rate may be based on expected rate of temperature change, power usage, medications, treatment timelines, and other factors. For example, if a drug is known to change average room temperature by one degree every second, the IMD 102 can provide enough readings to track changes in temperature without taking many readings at the same temperature. The default rate may be every 10 milliseconds so that the If IMD 102 is used for an extended treatment plan, the default rate may be reduced to every 25 milliseconds to reduce power usage and extend IMD 102 battery life. The rate may also change during operation based on current battery charge, current temperature, expected treatment timeline, and other factors. For example, because it takes time to properly raise the temperature, the rate of temperature readings may start slowly and increase as the temperature approaches the administration temperature of the drug.

During operation, IMD 102 may send data to network 402. In some embodiments, data is collected when the IMD 102 is connected to the tube 106, if a temperature spike occurs, when the drug begins to flow, and when the IMD 102 is removed. may include notices of, as well as other notices. The data may also include social button indicators for mood or other personal indicators from the user. A complete log of temperature readings stored in removable memory may be sent when the treatment is completed. In some examples, temperature readings may be sent periodically in small packets, such as a packet of temperature readings every two minutes.

IMD 102 may collect specific times associated with initiation (eg, attachment to tube), start of treatment, and end of treatment. These times can be determined by opening and closing the clip, the beginning of drug flow, and the end of drug flow. IMD 102 may include bubble sensors, flow monitors, and other mechanisms to monitor operation of infusion pump 104.

In other embodiments, the IMD 102 may send notifications only when the compliance computer 406 sends a request for detailed data logging. For example, the IMD 102 may send individual temperature measurements and timing information related to the removal of the infusion pump 104 from storage and the initiation of the user's treatment. Compliance computer 406 may verify that timing and temperature information is consistent with treatment compliance. If there is no match, or if the compliance computer 406 includes a flag to audit the treatment, the compliance computer 406 may send a request to the IMD 102 for the specified data set.

If the data resides in storage associated with network 402 separate from database 404, the data may also be sent to database 404 for further processing and analysis by instruction compliance computer 406. Compliance computer 406 may be associated with an infusion system provider, an insurance company, or a compliance monitoring company that may be independent of or part of the medical facility.

In some embodiments, the database 404 receives notifications and temperature data in near real-time with the treatment, and the compliance computer 406 performs compliance checks on the user's treatment plan. Directive compliance checking may include ensuring that the medication is removed from storage in an appropriate time frame to allow the medication to warm up through the treatment window. Directive compliance checks may also confirm that treatment has been initiated within a given treatment window. For example, for a patient treatment plan with morning treatment at 8:00 a.m., the instruction compliance check would occur if the IMD 102 was attached to the infusion pump between 6:45 and 7:15, and between 30 and 45 minutes after IMD attachment. It can be confirmed that treatment has started during this period. If the treatment plan calls for treatments every 12 hours, the window can be adjusted to follow the previous treatment. For example, if the first treatment was scheduled at 8:00 AM, but the user administers the treatment late at 9:00 AM, the next treatment will be scheduled by the compliance computer 406 at 9:00 PM. Database 404 may store update schedule information set by instruction compliance computer 406.

The instruction compliance check also tracks temperature gradient changes logged by the IMD 102 and posts this gradient change pattern into the database 404 to ensure that the temperature changes match the expected changes in the temperature of the specified drug. Compare with the stored slope change pattern. Each drug may have the expected temperature gradient pattern when removed from chilled storage and placed in an ambient room temperature environment. Database 404 may include multiple temperature gradient patterns for multiple drugs, starting temperatures, ambient temperatures, and treatment temperatures.

Instruction compliance computer 406 determines a baseline slope pattern by selecting a set of baseline slope patterns that have a starting tube temperature and ambient room temperature that are close to the corresponding data points from IMD 102 and averaging these slope patterns. It is possible. Instruction compliance computer 406 may then compare the baseline slope pattern to the current slope pattern from IMD 102. If the current gradient pattern is the same as the base gradient pattern or within a set deviation of the base gradient pattern, the compliance computer 406 removes the infusion pump 104 from storage and allows the medication to reach the therapeutic temperature. Decide on a treatment process to allow for treatment. The allowed deviation may be based on a deviation analysis of the gradient pattern in multiple similar situations. Upon making this determination, instruction compliance computer 406 may update database 404 to reflect that the user has followed the proper process. If the user follows the appropriate process and also meets other compliance requirements (e.g., time of treatment, duration of treatment, etc.), the system provides positive feedback that encourages further compliance throughout the process. message to the patient or caregiver. For example, the system may send a text message to the user's mobile device 408 and the caregiver's phone indicating successful treatment.

If the current slope pattern deviates by more than an allowable deviation from the expected slope pattern, the instruction compliance computer 406 creates an alert in the database and identifies the deviation. The instruction compliance computer 406 may determine that the deviation is indicative of handling error, inadvertent non-compliance with the instructions, or intentional non-compliance with the instructions and may set an alert based on this determination. For example, if the infusion pump 104 is inadvertently placed on a surface that is warmer than ambient temperature but not warm enough to damage the medication, the shift in the gradient pattern will indicate a rapid increase in temperature early in the process. This returns to the expected pattern, and treatment delivery appears to meet expected timelines and appropriate temperature changes. Compliance computer 406 may determine that the distorted gradient pattern is not indicative of a disturbance in overall compliance of the treatment. In such cases, the instruction compliance computer 406 may update the database 404 with a flag that checks for reoccurrence of patterns indicative of this deviation. The first time a distorted pattern is determined, the system may provide the same positive compliance output. However, if a pattern emerges, the compliance contact may receive a notification to further investigate the matter to determine why this deviation is occurring.

For another example, the instruction compliance computer 406 may determine that the IMD 102 data indicates that the user started treatment before the temperature rose sufficiently. Patterns of usage may indicate that this error is not a deliberate attempt to result in noncompliance with instructions. For example, if the database 404 shows a history of proper IMD 102 and infusion pump 104 usage with compliance, this one minor instance of non-compliance may be classified as inadvertent. Instruction compliance computer 406 may update database 404 to indicate the classification of instruction non-compliance and inattention. The system may then send a positive response to the patient's portable device 408 with an additional reminder to allow the infusion pump 104 to reach the appropriate temperature.

For another example, the instruction compliance computer 406 may determine that the user was intentionally noncompliant. For example, the IMD 102 data may indicate that the drug flowed at a faster flow rate than expected and began flowing before the temperature reached the correct dosing temperature. As another example, the data may show that the temperature increased rapidly, indicating that the drug may have been compromised by exposure to high temperatures. If the directive compliance computer 406 determines that these or other data indicate intentional noncompliance, the directive compliance computer 406 may contact the home care provider, health care facility, or other person to address the problem. The database 404 is updated with alerts that notify interested parties. Additionally, the system may send a response to the user indicating that the previous treatment did not follow the expected process. This may be presented on the mobile phone 408 as motivational text encouraging the user to properly follow the treatment plan.

The system may also send updates to home care providers, insurance companies, medical facilities, or other groups authorized to receive compliance updates. The system may also generate reports for involved parties. Reports may be used to improve medical treatment and for other purposes. For example, a positive compliance report in the medical file allows a physician to adjust and improve the treatment plan if the patient is readmitted. In contrast, a negative compliance report indicates that the drug plan may be appropriate, but a new method of administration or additional supervision may be needed for the drug plan to be successful. can be shown.

The system may also use social responses from the user to help adjust the response to best match the attitude exhibited by the patient. In some applications, the patient provides a psychosocial overview that establishes a baseline from which additional indicators throughout the treatment plan can be analyzed. Response and visit schedules may be established based on psychosocial analysis and compliance patterns obtained through the IMD 102 for the purpose of improving user compliance for medical treatment.

The system may continue to develop comparative data in database 404 and improve the accuracy of expected temperature gradients by aggregating and analyzing incoming temperature gradients over time. Database 404 may limit the aggregation of new slope patterns with respect to those flagged as related to compliant treatment. The system may anonymize all temperature gradient information built into the aggregated system.

In addition, the system continues to learn aggregated user patterns and user-specific patterns from infusion monitoring devices. Based on these patterns, which may continue to evolve, the system modifies communication behavior for the user. If the system detects a potential compliance problem for a particular drug over a period of time, the system can send notifications in advance of that period to encourage the patient to continue adhering to the treatment plan. obtain. For example, a 10-day treatment plan for antibiotics can often lead to compliance problems on the seventh day, when many patients feel better and compliance is no longer necessary. The system may send reminders of the need to properly complete the 10-day plan to help prevent recurrence. As another example, the system may recognize that patterns of social indicators are often indicative of possible compliance problems and may increase communications encouraging compliance. Alternatively, certain results may indicate a pattern of successful compliance with instructions that does not benefit from additional communication and reminders.

FIG. 5 shows another embodiment of an infusion monitoring device 502. Similar to IMD 102, this embodiment includes a body 504 and a cap 506. IMD 502 is shown in a closed configuration with cap 506 abutting body portion 504 about tube 508 . Cap 506 may be connected to body portion 504 by a sliding, hinged, flexible, or other connection.

In some examples, cap 506 may include a spring or other resilient component that biases cap 506 into a closed position against a side of body portion 504. This embodiment of IMD 502 includes a latch that holds cap 506 in place when cap 506 is in the closed position. The latch includes two protrusions 510 attached to the cap 506 and an arrow-shaped protrusion 512 extending from the body portion 504. When cap 506 is closed around tube 508, protrusion 510 passes by the side of arrow-shaped protrusion 512, which flexes inward to allow passage of the protrusion. The sides of arrow-shaped projection 512 then flex behind projection 510 back to the open position, preventing cap 506 from opening. In some embodiments, the latch holds the cap 506 in place during operation, but does not allow the user to reopen the cap 506 to remove the tube 508 and use the IMD 502 in another infusion pump. may be configured to do so.

In this example, IMD 502 has a visual output 514, which may be a light array, light bar, or display. In some examples, visual output 514 may be partitioned to allow various visual information to be presented along the bar. Visual output 514 may also provide feedback information as an alphanumeric output display. As discussed in FIG. 2, visual output 514 may provide various lighting characteristics indicative of various status information.

The invention being thus described and further illustrated in the claims, it will be obvious that the invention may be varied in many ways. Such variations are not to be considered a departure from the spirit and scope of the invention, and all such modifications are within the scope of the described apparatus and method, as will be apparent to those skilled in the art. intended to be included in