Systems, methods, and products for event monitoring

Abstract

To provide an improved system, device, product, device, and / or method for event monitoring.SOLUTION: A signal measured by a sensor connected to a needleless connector including a fluid flow channel can be acquired for determining, on the basis of the signal, an event associated with the needleless connector, such as at least one of a cleaning event in which a needleless connector is cleaned with a disinfectant; a washing event in which the needleless connector is washed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or arbitrary combinations of them. Display of the determined event can be provided.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to systems, methods, and articles of manufacture for event monitoring. [Background technology]

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 800,613, entitled "System, Method, and Product for Event Monitoring," filed February 4, 2019, the entire disclosure of which is incorporated herein by reference.

[0003] Drug infusion into the body is often achieved through a catheter inserted into either a peripheral vein (PIVC) or a central vein (PICC / CVC). The catheter may be connected to a pump via a needleless connector.

[0004] Proper catheter maintenance may include cleaning the needleless connector with a disinfectant after every disconnection / connection, regularly flushing the line with a cleaning solution to minimize residue buildup, and / or using a disinfectant cap when the needleless connector is not in use. These maintenance activities may be performed routinely as part of catheter maintenance, along with connecting and disconnecting IV lines, pushing medications from syringes, drawing blood, etc. Proper catheter maintenance helps to (i) reduce or prevent the accumulation and infusion of harmful bacteria into the body (e.g., infusion of harmful bacteria can result in catheter-related bloodstream infections (CRBSIs), which are associated with high mortality rates, and / or central line-associated bloodstream infections (CLABSIs), resulting in significant costs to hospitals due to extended patient stays; and (ii) minimize the likelihood of catheter blockage (e.g., blockages have been shown to lead to increased risk of CRBSIs by providing an inoculum for harmful bacteria, and may require the use of medications to remove the blockage or result in catheter replacement, which further increases patient safety risks due to increased CRBSIs, additional costs to hospitals, etc.).

[0005] Hospitals and home patient settings (e.g., nurses, caregivers, patient maintenance activities, etc.) have adopted protocols intended to ensure proper catheter maintenance. However, multiple studies have demonstrated poor adherence to these existing protocols, leading to suboptimal patient outcomes. Summary of the Invention

[0006] Thus, improved systems, devices, articles of manufacture, apparatus, and / or methods for event monitoring are provided.

[0007] According to some non-limiting embodiments or aspects, a system is provided that includes a needleless connector including a fluid flow path; one or more force sensors connected to the needleless connector; and one or more processors programmed and / or configured to receive force signals from the force sensors and, based on the force signals, determine at least one of a cleaning event where the needleless connector is cleaned with a disinfectant, a flushing event where the needleless connector is rinsed with a solution, a connection event where the needleless connector is connected to a medical device, a disconnection event where the needleless connector is disconnected from a medical device, or any combination thereof.

[0008] In certain non-limiting embodiments or aspects, the system further includes a communications circuit configured to transmit the force signal to a remote computing system.

[0009] In some non-limiting embodiments or aspects, the force sensor includes at least one of a piezoelectric element, a force sensitive resistive film (FSR) sensor, a strain gauge, or any combination thereof.

[0010] In some non-limiting embodiments or aspects, the force sensor is located between an outer surface of an inner wall of the needleless connector that defines a fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0011] In some non-limiting embodiments or aspects, the force sensor includes a plurality of force sensors positioned around the fluid flow path of the needleless connector between an inner wall of the needleless connector that defines the fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0012] In some non-limiting embodiments or aspects, the first end of the needleless connector includes a septum including a surface facing a first direction, the force sensor is configured to detect a force in a second direction that is perpendicular to the surface of the septum facing the first direction, and the one or more processors are further programmed and / or configured to determine a flush event based on the force signal indicative of the periodic force in the second direction that is perpendicular to the surface of the septum facing the first direction, where the flush event includes a pulsating flush event.

[0013] In some non-limiting embodiments or aspects, the force sensor includes a pressure sensor that is one of: in direct contact with fluid in the fluid flow path of the needleless connector; located within an interior wall of the needleless connector that defines the fluid flow path of the needleless connector; and located within a wall of a lumen connected to the needleless connector.

[0014] In certain non-limiting embodiments or aspects, the system further includes an optical sensor configured to detect at least one of a color signature and a reflectance of the medical device, and the one or more processors are further programmed and / or configured to determine a type of the medical device based on at least one of the color signature and the reflectance of the medical device.

[0015] In some non-limiting embodiments or aspects, the optical sensor may detect machine-readable information (e.g., a barcode) that may be used to identify a device, a device family, or a unique individual device, etc.

[0016] In certain non-limiting embodiments or aspects, the one or more processors are further programmed or configured to: determine, based on the force signal, a pattern of events including at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof; and determine, based on the pattern of events, a medication administration event in which a medication is administered to the patient via the needleless connector.

[0017] In certain non-limiting embodiments or aspects, the system further includes an identification sensor configured to detect an identification tag on a medical device connected to or coupled to the needleless connector.

[0018] In some non-limiting embodiments or aspects, the identification sensor includes a magnetometer and the identification tag includes a magnetic material.

[0019] In certain non-limiting embodiments or aspects, the system further includes a position sensor configured to detect movement of the needleless connector, and the one or more processors are further programmed and / or configured to determine at least one of patient movement and patient bed movement based on the detected movement of the needleless connector.

[0020] In certain non-limiting embodiments or aspects, the system further includes a color sensor configured to detect a color of the fluid in the fluid flow path of the needleless connector, and the one or more processors are further programmed and / or configured to determine at least one of withdrawing blood in the needleless connector and retaining blood in the needleless connector based on the color of the fluid detected in the fluid flow path of the needleless connector.

[0021] In certain non-limiting embodiments or aspects, the system further includes a visual indicator configured to provide a visual indication related to at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0022] According to certain non-limiting embodiments or aspects, a method is provided that includes measuring a force signal with a force sensor connected to a needleless connector including a fluid flow path; receiving the force signal from the force sensor with at least one processor; and determining, based on the force signal, with the at least one processor, at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.

[0023] In certain non-limiting embodiments or aspects, the method further includes transmitting, with the communications circuitry, the force signal to a remote computing system.

[0024] In some non-limiting embodiments or aspects, the force sensor includes at least one of a piezoelectric element, a force sensitive resistive film (FSR) sensor, a strain gauge, or any combination thereof.

[0025] In some non-limiting embodiments or aspects, the force sensor is located between an outer surface of an inner wall of the needleless connector that defines a fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0026] In some non-limiting embodiments or aspects, the force sensor includes a plurality of force sensors positioned around the fluid flow path of the needleless connector between an inner wall of the needleless connector that defines the fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0027] In some non-limiting embodiments or aspects, the first end of the needleless connector includes a septum including a surface facing a first direction, and the force sensor is configured to detect a force in a second direction that is perpendicular to the surface of the septum facing the first direction, and the method further includes determining, with at least one processor, a flush event based on the force signal indicative of the periodic force in the second direction that is perpendicular to the surface of the septum facing the first direction, wherein the flush event includes a pulsating flush event.

[0028] In some non-limiting embodiments or aspects, the force sensor includes a pressure sensor that is one of: in direct contact with fluid in the fluid flow path of the needleless connector; located within an interior wall of the needleless connector that defines the fluid flow path of the needleless connector; and located within a wall of a lumen connected to the needleless connector.

[0029] In certain non-limiting embodiments or aspects, the method further includes detecting, using an optical sensor, at least one of a color signature and a reflectance of the medical device, and determining, using at least one processor, a type of the medical device based on at least one of the color signature and the reflectance of the medical device.

[0030] In some non-limiting embodiments or aspects, the method further includes determining, with the at least one processor, a pattern of events based on the force signals, including at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof; and determining, with the at least one processor, a medication administration event in which a medication is administered to the patient via the needleless connector based on the pattern of events.

[0031] In some non-limiting embodiments or aspects, the force sensor for determining an event or a pattern of events based on a force signal includes a force sensor, a pressure sensor, a strain gauge or sensor, an accelerometer, an acoustic sensor, a microphone, a force-sensitive resistor (FSR), a stress sensor, or any combination thereof to measure the signal. The measured signal may be the result of a user's interaction with a device (e.g., a smart device, a needleless connector, a lumen, etc.) when the user handles the device, which may produce a force that can be measured by a force sensor, a pressure sensor, a strain sensor, a stress sensor, or any combination thereof. In some non-limiting embodiments or aspects, forces that are relatively higher frequency in nature may be created, such as forces that may be referred to as vibration and / or acoustic. For example, cleaning a connector may create relatively lower frequency signals (e.g., signals below 20 Hz) from user handling and relatively higher frequency forces from the interaction of a cotton swab with the surface of the connector.

[0032] Instead of or in addition to directly measuring forces using a transducer or the like, measuring changes in connector components can be used to indicate how a device (e.g., a needleless connector, a smart device, a lumen, etc.) is or is being used. For example, in a needleless connector, a central valve or membrane can be compressed along a central axis when a connection is made to another medical device, and the compression of the membrane can be measured using light and / or other encoding techniques (e.g., to determine the amount of compression, distance of compression, frequency of compression, time of compression, frequency, etc.).

[0033] In some non-limiting embodiments or aspects, a chemical sensor, a wetness sensor, an impedance sensor, a temperature sensor, or any combination thereof may be used to determine and / or indicate fluid on the surface of the needleless connector and / or smart device. For example, a chemical sensor, a wetness sensor, an impedance sensor, a temperature sensor, or any combination thereof may be employed to distinguish alcohol as it evaporates from a lumen (e.g., IV fluid), etc.

[0034] In certain non-limiting embodiments or aspects, the method further includes detecting, with an identification sensor, an identification tag on a medical device connected to or coupled to the needleless connector.

[0035] In some non-limiting embodiments or aspects, the identification sensor includes a magnetometer and the identification tag includes a magnetic material.

[0036] In certain non-limiting embodiments or aspects, the method further includes detecting movement of the needleless connector using a position sensor, one or more gyroscopes, one or more accelerometers, or any combination thereof, and determining, using at least one processor, at least one of patient movement and patient bed movement based on the detected movement of the needleless connector.

[0037] In certain non-limiting embodiments or aspects, the method further includes detecting a color of fluid in the fluid flow path of the needleless connector using a color sensor, and determining at least one of drawing blood in the needleless connector and retaining blood in the needleless connector based on the color of fluid detected in the fluid flow path of the needleless connector.

[0038] In certain non-limiting embodiments or aspects, the method further includes providing, with a visual indicator, a visual indication associated with at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0039] According to certain non-limiting embodiments or aspects, a needleless connector is provided, the needleless connector including: a fluid flow path; a force sensor configured to measure a force signal; a visual indicator; and one or more processors programmed and / or configured to: receive the force signal from the force sensor; determine based on the force signal at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof; and control the visual indicator to provide a visual indication related to at least one of the cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof.

[0040] In some non-limiting embodiments or aspects, the force sensor is located between an outer surface of an inner wall of the needleless connector that defines a fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0041] According to certain non-limiting embodiments or aspects, a computer program product is provided that includes at least one non-transitory computer-readable medium comprising program instructions that, when executed by at least one processor, cause the at least one processor to: acquire a force signal measured by a force sensor connected to a needleless connector including a fluid flow path; determine, based on the force signal, at least one of a cleaning event where the needleless connector is cleaned with a disinfectant, a flushing event where the needleless connector is rinsed with a solution, a connection event where the needleless connector is connected to a medical device, a disconnection event where the needleless connector is disconnected from a medical device, or any combination thereof; and provide an indication of the determined event.

[0042] According to certain non-limiting embodiments or aspects, a system is provided that includes a needleless connector including a fluid flow path, an acoustic sensor connected to the needleless connector, and one or more processors programmed and / or configured to receive a signal from the acoustic sensor that includes a sound signature and determine an event associated with the needleless connector based on the signal.

[0043] In certain non-limiting embodiments or aspects, the event associated with the needleless connector includes a connection event in which the needleless connector is connected to a medical device, and the one or more processors are further programmed and / or configured to determine, based on the sound signature, a type of medical device connected to the needleless connector from a plurality of types of medical devices.

[0044] In some non-limiting embodiments or aspects, the plurality of types of medical devices includes two or more of caps, syringes, tubing, medical device connectors, or any combination thereof.

[0045] In certain non-limiting embodiments or aspects, the one or more processors are further programmed and / or configured to determine a subtype of the determined type of medical device connected to the needleless connector from a plurality of subtypes of medical devices of that type based on the sound signature.

[0046] In certain non-limiting embodiments or aspects, the event associated with the needleless connector includes an operation of a medical device connected to the needleless connector, and the one or more processors are further programmed and / or configured to determine a state of the medical device connected to the needleless connector based on the sound signature.

[0047] In some non-limiting embodiments or aspects, the condition of the medical device includes a fresh condition or a used condition.

[0048] In some non-limiting embodiments or aspects, the medical device includes a syringe, and actuation of the syringe includes depressing a plunger of the syringe into a barrel of the syringe, and the depressing of the plunger of the syringe into the barrel of the syringe generates a sound signature.

[0049] In certain non-limiting embodiments or aspects, the syringe plunger includes one or more extrusions that, in combination with the syringe barrel, produce a sound signature when the syringe plunger is depressed into the syringe barrel.

[0050] In some non-limiting embodiments or aspects, the state of the medical device comprises a volume of fluid expelled from a syringe when a plunger of the syringe is depressed into a barrel of the syringe.

[0051] In some non-limiting embodiments or aspects, the medical device includes an antiseptic cap.

[0052] In some non-limiting embodiments or aspects, the sanitizer cap includes a switch, and operation of the sanitizer cap includes connecting the sanitizer cap to a needleless connector, and connecting the sanitizer cap to the needleless connector generates a sound signature when the state of the sanitizer cap includes an unused state, and when the state of the sanitizer cap includes a used state, connecting the sanitizer cap to the needleless connector is one of (i) not generating a sound signature, and (ii) generating another sound signature different from the sound signature generated when the state of the sanitizer cap includes an unused state.

[0053] In some non-limiting embodiments or aspects, the switch includes a bi-stable metal dome switch.

[0054] According to some non-limiting embodiments or aspects, a system is provided that includes a needleless connector including a fluid flow path and a septum; an optical sensor connected to the needleless connector, the optical sensor configured to detect movement of the septum; and one or more processors programmed and / or configured to receive a signal from the optical sensor related to the movement of the septum and determine an event related to the needleless connector based on the signal.

[0055] In certain non-limiting embodiments or aspects, the event associated with the needleless connector includes at least one of a connection event in which the needleless connector is connected to the medical device and a disconnection event in which the needleless connector is disconnected from the medical device.

[0056] In certain non-limiting embodiments or aspects, the septum includes one or more markings, and the optical sensor is configured to detect movement of the one or more markings to detect movement of the septum.

[0057] In certain non-limiting embodiments or aspects, the optical sensor is further configured to detect at least one of a color signature and a reflectance of the medical device, and the one or more processors are further programmed and / or configured to determine a type of the medical device based on at least one of the color signature and the reflectance of the medical device.

[0058] According to some non-limiting embodiments or aspects, a system is provided that includes a needleless connector including a fluid flow path, the needleless connector connected to a catheter hub of a catheter including a catheter lumen and a needle tip for delivering fluid from the catheter hub to a patient at an opposite end of the catheter lumen; a pressure sensor connected to the needleless connector, the pressure sensor configured to sense pressure transmitted through at least one of a fluid in the catheter and a material of the catheter; and one or more processors programmed and / or configured to receive a signal related to the sensed pressure from the pressure sensor and determine an event related to the catheter based on the signal.

[0059] In certain non-limiting embodiments or aspects, the catheter-related event includes a time at which a needle tip of the catheter enters a patient's blood vessel, and the one or more processors are programmed and / or configured to determine the time at which the needle tip of the catheter enters the blood vessel based on at least one of a heart rate, a respiratory rate, a blood pressure, a needle tip penetration force, or any combination thereof, determined from a signal related to the sensed pressure.

[0060] In certain non-limiting embodiments or aspects, the catheter-related event includes a clamping sequence, and the one or more processors are programmed and / or configured to determine the clamping sequence based on one or more changes over time in a signal related to the sensed pressure.

[0061] In certain non-limiting embodiments or aspects, the one or more processors are programmed and / or configured to determine, based on the determined clamping sequence and the type of needleless connector, whether the determined clamping sequence satisfies a clamping protocol associated with the type of needleless connector.

[0062] In certain non-limiting embodiments or aspects, the catheter-related event includes an occlusion of the catheter lumen, and the one or more processors are programmed and / or configured to determine the occlusion of the catheter lumen based on a rate of change of the sensed pressure.

[0063] Further non-limiting embodiments or aspects are described in the following numbered sections.

[0064] Section 1. A system comprising: a needleless connector including a fluid flow path; a force sensor connected to the needleless connector; and one or more processors programmed and / or configured to receive force signals from the force sensor and determine, based on the force signals, at least one of a cleaning event where the needleless connector is cleaned with a disinfectant, a flushing event where the needleless connector is rinsed with a solution, a connection event where the needleless connector is connected to a medical device, a disconnection event where the needleless connector is disconnected from a medical device, or any combination thereof.

[0065] Clause 2. The system of clause 1, further comprising a communications circuit configured to transmit the force signal to a remote computing system.

[0066] Section 3. The system of any one of sections 1 or 2, wherein the force sensor includes at least one of a piezoelectric element, a force sensitive resistive (FSR) sensor, a strain gauge, or any combination thereof. In some non-limiting embodiments or aspects, the force sensor may include an accelerometer, a gyroscope, an acoustic sensor, a microphone, or the like. For example, the force signal measured by the force sensor may be used in combination with information and / or data measured by the accelerometer and / or gyroscope to determine a movement event and classify the movement event as a patient repositioning, a patient fall, or the like.

[0067] Section 4. The system of any one of sections 1 to 3, wherein the force sensor is located between an outer surface of an inner wall of the needleless connector that defines a fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0068] Section 5. The system of any one of sections 1 to 4, wherein the force sensors include a plurality of force sensors positioned around the fluid flow path of the needleless connector between an inner wall of the needleless connector that defines the fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0069] Section 6. The system of any one of clauses 1-5, wherein the first end of the needleless connector includes a septum including a surface facing a first direction, the force sensor configured to detect a force in a second direction that is perpendicular to the surface of the septum facing the first direction, and the one or more processors are further programmed and / or configured to determine a flush event based on a force signal indicative of the periodic force in the second direction that is perpendicular to the surface of the septum facing the first direction, the flush event including a pulsating flush event.

[0070] Section 7. The system of any one of clauses 1 to 6, wherein the force sensor includes a pressure sensor, the pressure sensor being one of: in direct contact with fluid in the fluid flow path of the needleless connector; located within an interior wall of the needleless connector that defines the fluid flow path of the needleless connector; and located within a wall of a lumen connected to the needleless connector.

[0071] Section 8. The system of any one of clauses 1-7, further comprising an optical sensor configured to detect at least one of a color signature and a reflectance of the medical device, wherein the one or more processors are further programmed and / or configured to determine a type of the medical device based on at least one of the color signature and the reflectance of the medical device.

[0072] Section 9. The system of any one of clauses 1-8, wherein the one or more processors are further programmed or configured to: determine a pattern of events based on the force signal, the pattern of events including at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof; and determine a medication administration event in which a medication is administered to the patient via the needleless connector based on the pattern of events.

[0073] Clause 10. The system of any one of clauses 1 to 9, further comprising an identification sensor configured to detect an identification tag on a medical device connected to or coupled to the needleless connector.

[0074] Clause 11. The system of any one of clauses 1 to 10, wherein the identification sensor includes a magnetometer and the identification tag includes a magnetic material.

[0075] Clause 12. The system of any of clauses 1-11, further comprising a position sensor configured to detect movement of the needleless connector, wherein the one or more processors are further programmed and / or configured to determine at least one of patient movement and patient bed movement based on the detected movement of the needleless connector.

[0076] Section 13. The system of any of clauses 1-12, further comprising a color sensor configured to detect a color of fluid in the fluid flow path of the needleless connector, wherein the one or more processors are further programmed and / or configured to determine at least one of withdrawing blood in the needleless connector and retaining blood in the needleless connector based on the color of fluid detected in the fluid flow path of the needleless connector.

[0077] Clause 14. The system of any one of clauses 1-13, further comprising a visual indicator configured to provide a visual indication associated with at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0078] Section 15. A method comprising measuring a force signal with a force sensor connected to a needleless connector including a fluid flow path; receiving, with at least one processor, the force signal from the force sensor; and determining, with the at least one processor, based on the force signal, at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0079] Clause 16. The method of clause 15, further comprising transmitting the force signal to a remote computing system using the communications circuitry.

[0080] Clause 17. The method of clause 15 or clause 16, wherein the force sensor includes at least one of a piezoelectric element, a force sensitive resistive film (FSR) sensor, a strain gauge, or any combination thereof.

[0081] Clause 18. The method of any one of clauses 15 to 17, wherein the force sensor is located between an outer surface of an inner wall of the needleless connector that defines a fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0082] Clause 19. The method of any one of clauses 15 to 18, wherein the force sensors comprise a plurality of force sensors positioned around the fluid flow path of the needleless connector between an inner wall of the needleless connector that defines the fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0083] Clause 20. The method of any one of clauses 15-19, wherein the first end of the needleless connector includes a septum including a surface facing a first direction, and the force sensor is configured to detect a force in a second direction that is perpendicular to the surface of the septum facing the first direction, the method further comprising determining, with at least one processor, a flush event based on a force signal indicative of a periodic force in the second direction that is perpendicular to the surface of the septum facing the first direction, the flush event including a pulsating flush event.

[0084] Clause 21. The method of any one of clauses 15-20, wherein the force sensor includes a pressure sensor, the pressure sensor being one of: in direct contact with fluid in the fluid flow path of the needleless connector; located within an interior wall of the needleless connector that defines the fluid flow path of the needleless connector; and located within a wall of a lumen connected to the needleless connector.

[0085] Clause 22. The method of any one of clauses 15 to 21, further comprising: detecting, with an optical sensor, at least one of a color signature and a reflectance of the medical device; and determining, with at least one processor, a type of the medical device based on at least one of the color signature and the reflectance of the medical device.

[0086] Clause 23. The method of any one of clauses 15 to 22, further comprising: determining, with at least one processor, a pattern of events based on the force signal (and / or information and / or data from one or more gyroscopes and / or one or more accelerometers, etc.), including at least one of a cleaning event where the needleless connector is cleaned with a disinfectant, a flushing event where the needleless connector is rinsed with a solution, a connection event where the needleless connector is connected to a medical device, a disconnection event where the needleless connector is disconnected from a medical device, or any combination thereof; and determining, with the at least one processor, a medication administration event where a medication is administered to a patient via the needleless connector based on the pattern of events.

[0087] Clause 24. The method of any one of clauses 15 to 23, further comprising detecting an identification tag on a medical device connected to or coupled to the needleless connector using an identification sensor.

[0088] Clause 25. The method of any one of clauses 15 to 24, wherein the identification sensor includes a magnetometer and the identification tag includes a magnetic material.

[0089] Clause 26. The method of any one of clauses 15-25, further comprising detecting, with a position sensor, movement of the needleless connector; and determining, with at least one processor, at least one of patient movement and patient bed movement based on the detected movement of the needleless connector.

[0090] Clause 27. The method of any one of clauses 15-26, further comprising detecting a color of a fluid in the fluid flow path of the needleless connector with a color sensor, and determining at least one of withdrawing blood in the needleless connector and retaining blood in the needleless connector based on the color of the fluid detected in the fluid flow path of the needleless connector.

[0091] Clause 28. The method of any one of clauses 15-27, further comprising using a visual indicator to provide a visual indication associated with at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0092] Section 29. A needleless connector comprising: a fluid flow path; a force sensor configured to measure a force signal; a visual indicator; and one or more processors programmed and / or configured to: receive the force signal from the force sensor; determine based on the force signal at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof; and control the visual indicator to provide a visual indication related to at least one of the cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0093] Clause 30. The needleless connector of clause 29, wherein the force sensor is located between an outer surface of an inner wall of the needleless connector that defines a fluid flow path of the needleless connector and an inner surface of an outer wall of the needleless connector that surrounds the inner wall of the needleless connector.

[0094] Section 31. A computer program product comprising at least one non-transitory computer-readable medium containing program instructions that, when executed by at least one processor, cause the at least one processor to: acquire a force signal measured by a force sensor coupled to a needleless connector including a fluid flow path; and, based on the force signal, determine at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof; and provide an indication of the determined event.

[0095] Section 32. A system comprising: a needleless connector including a fluid flow path; an acoustic sensor connected to the needleless connector; and one or more processors programmed and / or configured to receive a signal from the acoustic sensor including a sound signature and determine an event associated with the needleless connector based on the signal.

[0096] Clause 33. The system of clause 32, wherein the event associated with the needleless connector includes a connection event in which the needleless connector is connected to a medical device, and wherein the one or more processors are further programmed and / or configured to determine, based on the sound signature, a type of medical device connected to the needleless connector from a plurality of types of medical devices.

[0097] Clause 34. The system of clause 32 or clause 33, wherein the plurality of types of medical devices includes two or more of a cap, a syringe, a tube, a medical device connector, or any combination thereof.

[0098] Clause 35. The system of any of clauses 32-34, wherein the one or more processors are further programmed and / or configured to determine a subtype of the determined type of medical device connected to the needleless connector from a plurality of subtypes of medical devices of that type based on the sound signature.

[0099] Clause 36. The system of any one of clauses 32-35, wherein the event associated with the needleless connector includes an operation of a medical device connected to the needleless connector, and wherein the one or more processors are further programmed and / or configured to determine a state of the medical device connected to the needleless connector based on the sound signature.

[0100] Clause 37. The system of any one of clauses 32 to 36, wherein the state of the medical device includes an unused state or a used state.

[0101] Clause 38. The system of any one of clauses 32 to 37, wherein the medical device includes a syringe, and actuation of the syringe includes depressing a plunger of the syringe into a barrel of the syringe, and wherein depressing the plunger of the syringe into the barrel of the syringe generates a sound signature.

[0102] Clause 39. The system of any one of clauses 32 to 38, wherein the syringe plunger includes one or more extrusions that, in combination with the syringe barrel, produce a sound signature when the syringe plunger is depressed into the syringe barrel.

[0103] Clause 40. The system of any one of clauses 32 to 39, wherein the state of the medical device comprises a volume of fluid expelled from the syringe when the syringe plunger is depressed into the syringe barrel.

[0104] Clause 41. The system of any one of clauses 32 to 40, wherein the medical device includes a disinfectant cap.

[0105] Clause 42. The system of any one of clauses 32-41, wherein the sanitizer cap includes a switch, and operation of the sanitizer cap includes connecting the sanitizer cap to the needleless connector, wherein connecting the sanitizer cap to the needleless connector generates a sound signature when a state of the sanitizer cap includes an unused state, and when the state of the sanitizer cap includes a used state, connecting the sanitizer cap to the needleless connector generates one of: (i) no sound signature; and (ii) another sound signature different from the sound signature generated when the state of the sanitizer cap includes an unused state.

[0106] Clause 43. The system of any one of clauses 32 to 42, wherein the switch comprises a bistable metal dome switch.

[0107] Section 44. A system comprising: a needleless connector including a fluid flow path and a septum; an optical sensor connected to the needleless connector, the optical sensor configured to detect movement of the septum; and one or more processors programmed and / or configured to receive a signal from the optical sensor related to the movement of the septum and determine an event related to the needleless connector based on the signal.

[0108] Clause 45. The system of clause 44, wherein the event associated with the needleless connector includes at least one of a connection event in which the needleless connector is connected to the medical device and a disconnection event in which the needleless connector is disconnected from the medical device.

[0109] Clause 46. The system of clause 44 or clause 45, wherein the septum includes one or more markings, and the optical sensor is configured to detect movement of the one or more markings to detect movement of the septum.

[0110] Clause 47. The system of any of clauses 44-46, wherein the optical sensor is further configured to detect at least one of a color signature and a reflectance of the medical device, and wherein the one or more processors are further programmed and / or configured to determine a type of the medical device based on at least one of the color signature and the reflectance of the medical device.

[0111] Section 48. A system comprising: a needleless connector including a fluid flow path, the needleless connector connected to a catheter hub of a catheter including a catheter lumen and a needle tip for delivering fluid from the catheter hub to a patient at an opposite end of the catheter lumen; a pressure sensor connected to the needleless connector, the pressure sensor configured to sense pressure transmitted through at least one of a fluid in the catheter and a material of the catheter; and one or more processors programmed and / or configured to receive a signal related to the sensed pressure from the pressure sensor and determine an event related to the catheter based on the signal.

[0112] Clause 49. The system of clause 48, wherein the catheter-related event includes a time at which a needle tip of the catheter enters a blood vessel of the patient, and wherein the one or more processors are programmed and / or configured to determine the time at which the needle tip of the catheter enters the blood vessel based on at least one of a heart rate, a respiratory rate, a blood pressure, a needle tip penetration force, or any combination thereof, determined from the sensed pressure-related signal.

[0113] Clause 50. The system of clause 48 or clause 49, wherein the catheter-related events include a clamping sequence, and wherein the one or more processors are programmed and / or configured to determine the clamping sequence based on one or more changes over time in the sensed pressure-related signal.

[0114] Clause 51. The system of any of clauses 48-50, wherein the one or more processors are programmed and / or configured to determine, based on the determined clamping sequence and the type of needleless connector, whether the determined clamping sequence satisfies a clamping protocol associated with the type of needleless connector.

[0115] Clause 52. The system of any of clauses 48-51, wherein the catheter-related event includes an occlusion of the catheter lumen, and wherein the one or more processors are programmed and / or configured to determine the occlusion of the catheter lumen based on a rate of change of the sensed pressure. [Brief explanation of the drawings]

[0116] [Figure 1] FIG. 1 illustrates a non-limiting embodiment or aspect of an environment in which the systems, devices, products, apparatuses, and / or methods described herein may be implemented. [Figure 2A] 2 is a diagram of a non-limiting embodiment or aspect of an implementation of one or more systems and / or one or more devices of FIG. 1. [Figure 2B] 2 is a diagram of a non-limiting embodiment or aspect of an implementation of one or more systems and / or one or more devices of FIG. 1. [Figure 2C] 2 is a diagram of a non-limiting embodiment or aspect of an implementation of one or more systems and / or one or more devices of FIG. 1. [Figure 3] 1 and 2A-2C are diagrams of non-limiting embodiments or aspects of components of one or more devices and / or one or more systems of FIGS. [Figure 4A] FIG. 10 is a side view of a non-limiting embodiment or aspect of an implementation of a needleless connector. [Figure 4B] FIG. 10 is a side view of a non-limiting embodiment or aspect of an implementation of a smart device and a needleless connector. [Figure 4C]FIG. 10 is a side view of a non-limiting embodiment or aspect of an implementation of a smart device and a needleless connector. [Figure 5A] FIG. 1 is a perspective view of a non-limiting embodiment or aspect of an implementation of a smart device and a needleless connector. [Figure 5B] FIG. 10 is a top view of a non-limiting embodiment or aspect of an implementation of a smart device and a needleless connector. [Figure 5C] 1 is a graph of a non-limiting embodiment or aspect of a force signal over time. [Figure 6A] 2 illustrates a non-limiting embodiment or aspect of an output of one or more systems and / or one or more devices of FIG. 1. [Figure 6B] 2 illustrates a non-limiting embodiment or aspect of an output of one or more systems and / or one or more devices of FIG. 1. [Figure 7] 1A-1C are diagrams of non-limiting embodiments or aspects of implementations of smart devices for detecting drug extravasation and / or infiltration in catheters. [Figure 8] 1 is a flowchart of a non-limiting embodiment or aspect of a process for identifying a lumen. [Figure 9] 1 is a flowchart of a non-limiting embodiment or aspect of a process for identifying a lumen. [Figure 10] 1 is a flowchart of a non-limiting embodiment or aspect of a process for locating a needle tip. [Figure 11] 1 is a flowchart of a non-limiting embodiment or aspect of a process for event monitoring. [Figure 12] FIG. 1 is a side view of a non-limiting embodiment or aspect of a syringe implementation. [Figure 13A] 1A and 1B are perspective and side views of a non-limiting embodiment or aspect of an implementation of a sanitizer cap. [Figure 13B] 1A and 1B are perspective and side views of a non-limiting embodiment or aspect of an implementation of a sanitizer cap. [Figure 13C]1A and 1B are perspective and side views of a non-limiting embodiment or aspect of an implementation of a sanitizer cap. DETAILED DESCRIPTION OF THE INVENTION

[0117] It is to be understood that the present disclosure may assume various alternative variations and step sequences unless expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the accompanying drawings, and described in the following specification, are merely exemplary, non-limiting embodiments or aspects. Hence, specific dimensions and other physical characteristics relating to the embodiments or aspects disclosed herein are not to be considered limiting.

[0118] For purposes of the following description, the terms "end," "top," "bottom," "right," "left," "vertical," "horizontal," "upper," "lower," "transverse," and "longitudinal," and their derivatives, refer to an embodiment or aspect as they refer to orientations in the drawings. However, it should be understood that an embodiment or aspect may assume various alternative variations and step sequences, unless expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are non-limiting, exemplary embodiments or aspects only. Accordingly, specific dimensions and other physical characteristics relating to an embodiment or aspect disclosed herein should not be considered limiting unless otherwise specified.

[0119] As used herein, aspects, components, elements, structures, acts, steps, functions, instructions, and the like should not be construed as critical or essential unless expressly stated as such. Also, as used herein, the articles "a" and "an" are inclusive of one or more items and may be used interchangeably with "one or more" and "at least one." Furthermore, as used herein, the term "set" is inclusive of one or more items (e.g., related items, unrelated items, combinations of related and unrelated items, etc.) and may be used interchangeably with "one or more" or "at least one." Where only one item is intended, the term "one" or similar language is used. Also, as used herein, the terms "has," "have," "having," and the like are intended to be open-ended. Furthermore, the phrase "based on" is intended to mean "based at least in part on," unless expressly stated otherwise.

[0120] As used herein, the terms “communication” and “communicating” may refer to receiving, accepting, sending, forwarding, providing, etc., information (e.g., data, signals, messages, instructions, commands, etc.). One unit (e.g., a device, a system, a component of a device or system, a combination thereof, etc.) in communication with another unit means that one unit can directly or indirectly send and / or receive information to and from the other unit. This may refer to a direct or indirect connection that is wired and / or wireless in nature. Furthermore, two units may be in communication with each other even though the information transmitted may be modified, processed, relayed, and / or routed between the first and second units. For example, a first unit may be in communication with a second unit even though the first unit passively receives information and does not actively transmit information to the second unit. As another example, a first unit may be in communication with a second unit if at least one intermediate unit (e.g., a third unit located between a first unit and a second unit) processes information received from the first unit and communicates the processed information to the second unit. In some non-limiting embodiments or aspects, a message may refer to a network packet (e.g., a data packet, etc.) containing data. It will be appreciated that many other configurations are possible.

[0121] As used herein, the term "computing device" may refer to one or more electronic devices configured to communicate directly or indirectly with or over one or more networks. A computing device may be a mobile or portable computing device, a desktop computer, a server, etc. Furthermore, the term "computer" may refer to any computing device that includes the components necessary to receive, process, and output data, typically including a display, a processor, memory, input devices, and a network interface. A "computing system" may include one or more computing devices or computers. An "application" or "application program interface" (API) refers to computer code or other data organized on a computer-readable medium that can be executed by a processor to facilitate interaction between software components, such as a client-side front-end for receiving data from a client and / or a server-side back-end. An "interface" refers to a generated display, such as one or more graphical user interfaces (GUIs), with which a user may interact directly or indirectly (e.g., through a keyboard, mouse, touchscreen, etc.). Furthermore, multiple computers, e.g., servers or other computing devices, communicating directly or indirectly in a network environment may constitute a "system" or a "computing system."

[0122] It will be apparent that the systems and / or methods described herein may be implemented in different forms, such as hardware, software, or a combination of hardware and software. The actual specialized control hardware or software code used to implement these systems and / or methods does not limit the implementation. Thus, the operation and behavior of the systems and / or methods are described herein without regard to specific software code, and it should be understood that software and hardware can be designed to implement the systems and / or methods based on the description herein.

[0123] Non-limiting embodiments or aspects are described herein in terms of thresholds. As used herein, meeting a threshold may refer to a value being greater than the threshold, more than the threshold, higher than the threshold, equal to or greater than the threshold, less than the threshold, less than the threshold, lower than the threshold, less than or equal to the threshold, or equal to the threshold. In some non-limiting embodiments or aspects, meeting a threshold may refer to the recognition of a pattern in a signal as a result of pattern recognition techniques, data mining techniques, gradient signal analysis, X-ray chart analysis, etc. applied to the signal. For example, meeting a threshold may be based on a dynamic time-based analysis of the signal.

[0124] Improved systems, devices, products, apparatus, and / or methods for event monitoring are provided. Existing systems for monitoring integrity events may not incorporate sensors into the needleless connector for use during an integrity event. As such, existing systems for integrity monitoring may not have a mechanism for automatically detecting cleaning, flushing, connection events, and / or disconnection events in the needleless connector. Therefore, existing systems for integrity monitoring may not ensure proper catheter maintenance and / or may lead to suboptimal patient outcomes.

[0125] Non-limiting embodiments or aspects of the present disclosure are directed to systems, devices, products, apparatus, and / or methods that use a sensor connected to a needleless connector to acquire a signal. For example, non-limiting embodiments or aspects of the present disclosure are directed to systems, devices, products, apparatus, and / or methods that use a force sensor connected to a needleless connector to acquire a force signal (e.g., a signal indicative of at least one of: an instantaneous force, an instantaneous pressure, an instantaneous vibration, a dynamic or changing force and / or force transfer change over time, a dynamic or changing pressure and / or force transfer change over time, a dynamic or changing vibration and / or force transfer change over time, etc.). It should be noted that, as used herein, the term "force sensor connected to a needleless connector" may refer to a force sensor of the present application that is physically coupled to the needleless connector to acquire a force signal. Alternatively, the term "force sensor connected to a needleless connector" may refer to a force sensor of the present application that is provided for indirect communication with the needleless connector to acquire a force signal. In such an indirect configuration, the sensor may be adapted to provide a measure of force and / or position, and the intermediate coupler may communicate the force and / or position from the needleless connector to the sensor. In some non-limiting embodiments or aspects, the force sensor may include at least one of a force sensor, a piezoelectric element, a force sensitive resistive (FSR) sensor, a strain gauge, a mechanical switch, a flow sensor, a pressure sensor, an acoustic sensor, a microphone, an accelerometer, or any combination thereof.

[0126] In some non-limiting embodiments or aspects, the method may include obtaining a signal measured by a sensor connected to a needleless connector including a fluid flow path; determining, based on the signal, at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from the medical device, or any combination thereof; and providing an indication of the determined event.

[0127] In this manner, non-limiting embodiments or aspects of the present disclosure provide for more automatic compliance with catheter maintenance protocols and / or more optimal patient outcomes. For example, non-limiting embodiments or aspects of the present disclosure provide for detecting cleaning, flushing, connecting, and / or disconnecting events at the needleless connector through the incorporation of one or more sensors in and / or at the needleless connector that allow for improved tracking of and feedback regarding catheter compliance protocols, as well as the incorporation of a secondary sensor that can indicate location status to improve patient outcomes.

[0128] Referring now to Figure 1, Figure 1 is a diagram of an example environment 100 in which the devices, systems, methods, and / or products described herein may be implemented. As shown in Figure 1, environment 100 includes a medication source system 102, a smart device 104, a communication network 106, a central computing system 108, and a terminal / mobile computing system 110. The systems and / or devices of environment 100 may be interconnected via wired connections, wireless connections, or a combination of wired and wireless connections.

[0129] In some non-limiting embodiments or aspects, the drug source system 102 includes one or more devices capable of delivering one or more fluids to one or more lumens (e.g., fluid lines, IV lines, etc.). For example, the drug source system 102 may include one or more manual fluid delivery systems (e.g., one or more IV bags, one or more syringes, etc.) and / or an infusion pump system including one or more infusion pumps. In some non-limiting embodiments, the smart device 104 may include multiple smart devices 104 (e.g., one or more other and / or different types of smart devices 104, etc.).

[0130] In some non-limiting embodiments or aspects, the drug source system 102 includes one or more devices capable of receiving information and / or data from and / or communicating information and / or data to the smart devices 104, the communication network 106, the central computing system 108, and / or the terminal / mobile computing system 110. For example, the drug source system 102 may include one or more computing systems (e.g., one or more computing devices, one or more mobile computing devices, etc.) including one or more processors.

[0131] Further details regarding non-limiting embodiments or aspects of the drug source system 102 are provided below with respect to FIGS. 2A, 2C, and 3.

[0132] In some non-limiting embodiments or aspects, the smart device 104 includes one or more devices capable of receiving information and / or data from and / or communicating information and / or data to the drug source system 102, one or more other smart devices 104, the communication network 106, the central computing system 108, and / or the terminal / mobile computing system 110. For example, the smart device 104 may include one or more computing systems (e.g., one or more computing devices, one or more mobile computing devices, etc.) including one or more processors. In some non-limiting embodiments or aspects, the smart device 104 may be capable of receiving information (e.g., from the drug source system 102 (e.g., from the drug source controller 204 and / or from the drug source device 206), from the terminal / mobile computing system 110, from one or more other smart devices 104, etc.) via a short-range wireless communication connection (e.g., an NFC or proprietary communication connection, an RFID communication connection, a Bluetooth® communication connection, etc.) and / or communicating information (e.g., to the drug source system 102 (e.g., to the drug source controller 204 and / or from the drug source device 206), to the terminal / mobile computing system 110, to one or more other smart devices 104, etc.) via a short-range wireless communication connection (e.g., to the drug source system 102 (e.g., to the drug source controller 204 and / or to the drug source device 206), to the terminal / mobile computing system 110, to one or more other smart devices 104, etc.).

[0133] 6B, the smart device 104 may provide direct patient feedback (e.g., via LED illumination to a nurse, etc.) in response to (i) detecting that the needleless connector 214 and / or its lumen 212 have not been cleaned for a predetermined period of time and / or before a scheduled use, (ii) detecting that the needleless connector 214 and / or its lumen 212 have not been cleaned for a sufficient period of time before accessing the catheter line, (iii) detecting that flushing of the needleless connector 214 and / or lumen 212 is scheduled, (iv) detecting that a disinfection cap was not attached after a previous access of the needleless connector 214 and / or lumen 212, etc. For example, the smart device 104 may include the needleless connector 214, which may be configured to detect at least one of a cleaning event, a flushing event, a connecting or capping event, or any combination thereof. As an example, the needleless connector 214 may be configured to provide information and / or data related to a detected cleaning event, a detected flushing event, a detected connecting or capping event, and / or a detected disconnection event (e.g., using the processor 304, memory 306, storage component 308, input component 310, output component 312, etc.) for storing the events and reporting compliance performance for monitoring compliance events.

[0134] Further details regarding non-limiting embodiments or aspects of smart device 104 are provided below with respect to Figures 2A-2C, 3, 4A-4C, 5A-5C, 6A, 6B, and 7.

[0135] In some non-limiting embodiments or aspects, the communication network 106 includes one or more wired and / or wireless networks. For example, the communication network 106 may include a cellular network (e.g., a Long Term Evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., a public switched telephone network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, an optical fiber-based network, a cloud computing network, etc., and / or any combination of these or other types of networks.

[0136] In some non-limiting embodiments or aspects, the central computing system 108 includes one or more devices capable of receiving information and / or data from and / or communicating information and / or data to the medication source system 102, the smart device 104, the communication network 106, and / or the terminal / mobile computing system 110. For example, the medication source system 102 may include one or more computing systems (e.g., one or more computing devices, one or more mobile computing devices, etc.) including one or more processors. In some non-limiting embodiments or aspects, the central computing system 108 includes a secure hospital server and / or one or more secure hospital databases that store personally identifiable information (PII) and / or Health Insurance Portability and Accountability Act (HIPAA) protected information.

[0137] In some non-limiting embodiments or aspects, the terminal / mobile computing system 110 includes one or more devices capable of receiving information and / or data from and / or communicating information and / or data to the medication source system 102, the smart device 104, the communication network 106, and / or the central computing system 108. For example, the terminal / mobile computing system 110 may include one or more computing systems (e.g., one or more computing devices, one or more mobile computing devices, etc.) including one or more processors. In some non-limiting embodiments or aspects, the terminal / mobile computing system 110 includes a nurse's station throughout the hospital. For example, as shown in implementation 600A of FIG. 6A , the terminal / mobile computing system 110 may provide bedside nurse support (e.g., recording each access to the needleless connector 214 and / or lumen 212 in real time and feedback to the nurse when it is determined that cleaning or flushing is scheduled or required according to the recorded access), nursing station manager support (e.g., optimizing the flushing procedure to reduce workflow and improve timing targets for flushing the needleless connector 214 and / or lumen 212), retrospective reporting for nursing management (e.g., cleaning duration of the needleless connector 214 and / or lumen 212, flushing technique, time between flushes, etc.), and the like.

[0138] 2A-2C, which are diagrams of non-limiting embodiments or aspects of an implementation 200 of one or more systems and / or one or more devices of FIG. 1. As shown in FIGS. 2A and 2C, the drug source system 102 may include a drug source controller 204 and / or one or more drug source devices 206 (e.g., multiple drug source devices 206a, 206b, ... 206n, etc.). As an example, the drug source controller 204 may include an infusion pump controller, and / or the drug source device 206 may include an infusion pump. In such an example, the drug source system 102 may include a BD Alaris™ system. For example, the drug source system 102 may include a BD Alaris™ PC unit and one or more BD Alaris™ pump modules. As another example, the drug source controller 204 may include a bedside console or computing device that may be separate from the infusion pump system, and / or the drug source device 206, which may be separate from the infusion pump, may be associated with and / or connected to a drug source (e.g., an IV bag, a syringe, the end of an IV line adjacent to the IV bag or syringe, etc.).

[0139] 2A, multiple drug source devices 206a, 206b, ... 206n may be connected to multiple lumens (e.g., fluid lines, etc.) 202a, 202b, ... 202n (e.g., for receiving fluids and / or drugs in the drug source system 102) and / or multiple lumens (e.g., fluid lines, etc.) 212a, 212b, ... 212n (e.g., for delivering fluids and / or drugs from the drug source system 102, etc.). As shown in FIG. 2C, the drug source device 206 may include a pairing input 208 (e.g., a button, an input component 310, etc.) and / or a visual indicator 210 (e.g., a multi-colored LED, an output component 312, etc.). As shown in FIGS. 2A and 2B, multiple lumens 212a, 212b, ... 212n may be connected to multiple smart devices 104a, 104b, ... 104n.

[0140] In some non-limiting embodiments or aspects, smart device 104 is configured to be removably connected to a portion of lumen 212 proximate needleless connector 214, such as an IV lumen (e.g., a peripherally inserted central venous catheter (PICC), a peripheral intravenous catheter (PIVC), a central venous catheter (CVC), etc.). For example, smart device 104 may include a clamp, adhesive, friction fit, and / or other attachment means configured to removably connect smart device 104 to needleless connector 214 and / or lumen 212 proximate needleless connector 214. By way of example, as shown in FIGS. 2A and 2B , smart device 104a may be connected to a catheter lumen connecting a catheter to needleless connector 214 and / or lumen 212b, and / or smart device 104n may be connected to a catheter lumen connecting a catheter to needleless connector 214 and / or lumen 212a. In some non-limiting embodiments or aspects, the smart device 104 includes a needleless connector 214. For example, the smart device 104 may be integrated with the needleless connector 214 (e.g., within the needleless connector 214 and / or within the catheter hub of the needleless connector of the fluidly invasive device, etc.). As an example, as shown in FIGS. 2A and 2B , the smart device 104b may include the needleless connector 214 and / or a catheter hub connecting a catheter lumen to the lumen 212n via a Y-site connector. In such an example, the smart device 104 may include the needleless connector 214 including the housing 402 of the needleless connector 214 within the housing 250 (e.g., integrated with the housing 250, contained within the housing 250, etc.). For example, the needleless connector 214 may embed the housing 250, the smart device 104, and / or its components within the housing 402 of the needleless connector 214 (or vice versa) or its components connected to the housing 250, the smart device 104, and / or the housing 402.The advantage of adding a sensor to a standard design is that the clinically validated performance characteristics and regulatory reporting remain unchanged. Sterilization techniques that are optimal for fluid path components may not be ideal for electronic devices, therefore. , made A design that does not change identified components that can be added later during construction and assembly or snapped on by the end user can have advantages.

[0141] 4A, which is a side view of a non-limiting embodiment or aspect of an implementation 400A of a needleless connector 214. As shown in FIG. 4A, the needleless connector 214 may include a fluid flow path in a housing 402 between an inlet 404 and an outlet 406 opposite the inlet 404. The inlet 404 may be fluidically sealed by a displaceable septum 408 configured to be displaced to open or connect the inlet 404 to the fluid flow path in response to connection of the needleless connector 214 to a medical device (e.g., an infusion pump, an IV bag, a syringe, an IV line, etc.). For example, the needleless connector 214 may include a BD MaxPlus® connector, a BD MaxZero® needleless connector, etc. However, non-limiting embodiments or aspects are not limited thereto, and the needleless connector 214 may include any needleless connector 214 for use in fluid administration. For example, the needleless connector 214 may include a port, manifold, stopcock, open connector, luer connector, and / or any other connector that does not rely on (but may or may not include) a needle to form a connection with the device and / or patient. In some non-limiting embodiments or aspects, one or more components of the smart device 104 may be included within the housing 402 of the needleless connector 214. For example, the housing 402 of the needleless connector 214 may include the housing 250 of the smart device 104 (e.g., the housing 250 may be integrated with the housing 402, contained within the housing 402, etc.).

[0142] 2C , smart device 104 may include a visual indicator 252 (e.g., one or more visual indicators, multiple visual indicators, multi-colored LED, multiple LEDs, output component 312, etc.), a sensor 254 (e.g., one or more sensors, multiple sensors, a sensor suite, etc.), a pairing input 256 (e.g., one or more buttons, one or more force sensors, one or more accelerometers, input component 310, etc.), a battery 258, and / or an energy harvester 260 (e.g., a thermoelectric energy harvester, a photovoltaic energy harvester, a piezoelectric energy harvester, etc.). All or a portion of visual indicator 252, sensor 254, pairing input 256, battery 258, energy harvester 260, and needleless connector 214 may be included within housing 250 of smart device 104. Visual indicator 252 may be visible through and / or extend from a sidewall of housing 250. The battery 258 and / or energy harvester 260 may provide power to operate components of the smart device 104, such as the visual indicator 252, the sensor 254, the pairing input 256, the rechargeable battery of the battery 258, and one or more components of the device 300 included in the smart device 104.

[0143] In some non-limiting embodiments or aspects, the smart device 104 may include labels (e.g., human-readable labels, etc.) that characterize the visual indicators 252 of the smart device 104. For example, as shown in implementation 400C of FIG. 4C , the smart device 104 may include labels (e.g., on a sidewall of the housing 250, etc.) associated with the visual indicators 252 that characterize each visual indicator 252 so as to provide an indication related to a particular event, such as one of a cleaning event (e.g., labeled "CLEAN") in which the needleless connector 214 is cleaned with a disinfectant, a flushing event (e.g., labeled "Flush") in which the needleless connector 214 is rinsed with a solution, a connecting or capping event (e.g., labeled "CAP") in which the needleless connector 214 is connected to a medical device, etc. In some non-limiting embodiments or aspects, the smart device 104 may include a single visual indicator 252 (e.g., as shown in implementation 400B of FIG. 4B ). For example, the smart device 104 may control the single visual indicator 252 to illuminate in a particular color and / or in a particular pattern to indicate or prompt the user to do things like illuminate a continuous green color in response to the needleless connector 214 being cleaned for a predetermined period of time (e.g., 15 seconds, etc.), illuminate a flashing green color in response to an appropriate pulsating flush being performed, illuminate a flashing red color in response to determining that the needleless connector 214 has not been pulsating flushed for a predetermined period of time (e.g., 88 hours, etc.), illuminate a continuous red color in response to determining that the needleless connector 214 has not been capped with a disinfectant cap for a predetermined period of time (e.g., one minute or more, etc.), etc.

[0144] In some non-limiting embodiments or aspects, the communication circuitry (e.g., communication interface 314, etc.) of the drug source device 206 is configured to establish communication with the communication circuitry (e.g., communication interface 314, etc.) of the smart device 104 based on user input to the pairing input 208 of the drug source device 206 and the pairing input 256 of the smart device 104. For example, the drug source device 206 may establish a short-range wireless communication connection (e.g., an NFC communication connection, an RFID communication connection, a Bluetooth® communication connection, etc.) with the smart device 104. As an example, the visual indicator 210 may be configured to emit a predetermined light pattern (e.g., rapidly blink to indicate that the drug source device 206 is in pairing mode) in response to a predetermined user input to the pairing input 208 of the drug source device 206 (e.g., in response to a user pressing and holding a button on the pairing input 208, etc.). In such an example, the smart device 104 may be configured to establish communication with the drug source device 206 (e.g., pair the drug source device 206 with the smart device 104 and / or activate a pairing sequence for pairing therewith) in response to a predetermined user input to the pairing input 256 of the smart device 104 (e.g., in response to a user pressing and holding a button on the pairing input 256) at the same time that the drug source device 206 is in pairing mode.

[0145] In some non-limiting embodiments or aspects, when the drug source device 206 is paired with the smart device 104, the visual indicator 210 of the drug source device 206 and the visual indicator 252 of the smart device 104 are configured to provide the same type of visual output (e.g., the same color light from a multi-colored LED, the same pattern of light, etc.). For example, referring again to FIG. 2A, drug source device 206a may be paired with smart device 104n, where drug source device 206a and smart device 104n may each output light of a first color (e.g., red light), drug source device 206b may be paired with smart device 104a, where drug source device 206b and smart device 104a may each output light of a second color (e.g., green light), drug source device 206n may be paired with smart device 104b, where drug source device 206n and smart device 104b may each output light of a third color (e.g., blue light), etc.

[0146] In some non-limiting embodiments or aspects, the sensor 254 may include one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.), one or more accelerometers, one or more gyroscopes, one or more pressure sensors, one or more acoustic sensors (e.g., an acoustic sensor configured to detect a sound signature associated with a type, state, and / or operation of a medical device, etc.), one or more optical sensors (e.g., a septum movement, a color signature and / or reflection of a medical device connected to the smart device 104, etc.), one or more optical sensors (e.g., a septum movement, a color signature and / or reflection of a medical device connected to the smart device 104, etc.), one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.), one or more pressure sensors, one or more acoustic sensors (e.g., an acoustic sensor configured to detect a sound signature associated with a type, state, and / or operation of a medical device, etc.), one or more optical sensors (e.g., a septum movement, a color signature and / or reflection of a medical device connected to the smart device 104, etc.), one or more pressure sensors (e.g., one or more pressure sensors ... the needleless connector 214, such as an optical sensor configured to detect a magnetic material, a barcode scanner configured to read a barcode, an identification sensor configured to detect an identification tag on a medical device connected to or attached to the needleless connector 214, etc.), one or more position sensors (e.g., a position sensor configured to detect movement of the smart device 104, etc.), one or more RGB color sensors, one or more mechanical switches, one or more flow sensors (e.g., ultrasonic flow sensors, thermal flow sensors, etc.), or any combination thereof.

[0147] The number and configuration of systems, devices, and networks shown in Figures 1 and 2A-2C are provided as an example. There may be additional, fewer, different, or differently configured systems, devices, and / or networks in the systems, devices, and / or networks shown in Figures 1 and 2A-2C. Furthermore, two or more systems or devices shown in Figures 1 and 2A-2C may be implemented within a single system or device, or a single system or device shown in Figures 1 and 2A-2C may be implemented as multiple, distributed systems or devices. Additionally or alternatively, a set of systems or devices (e.g., one or more systems, one or more devices, etc.) of environment 100 and / or implementation 200 may perform one or more functions described as being performed by another set of systems or another set of devices in environment 100 and / or implementation 200.

[0148] 3, which is a diagram of example components of a device 300. The device 300 may correspond to one or more devices of the drug source system 102, the smart device 104, and / or one or more devices of the communication network 106, one or more devices of the central computing system 108, one or more devices of the terminal / mobile computing system 110, one or more devices of the drug source controller 204, and / or one or more devices of the drug source device 206. In some non-limiting embodiments or aspects, one or more devices of the drug source system 102, the smart device 104, and / or one or more devices of the communication network 106, one or more devices of the central computing system 108, one or more devices of the terminal / mobile computing system 110, one or more devices of the drug source controller 204, and / or one or more devices of the drug source device 206 may include at least one device 300 and / or at least one component of the device 300. As shown in FIG. 3, device 300 may include a bus 302, a processor 304, a memory 306, a storage component 308, an input component 310, an output component 312, and a communication interface 314.

[0149] The bus 302 may include components that enable communication between the components of the device 300. In some non-limiting embodiments or aspects, the processor 304 may be implemented in hardware, firmware, or a combination of hardware and software. For example, the processor 304 may include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and / or any processing component (e.g., a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), a microcontroller (MCU), etc.) that can be programmed to perform functions. The memory 306 may include random access memory (RAM), read-only memory (ROM), and / or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and / or instructions for use by the processor 304.

[0150] The storage component 308 may store information and / or software related to the operation and use of the device 300. For example, the storage component 308 may include a hard disk (e.g., a magnetic disk, optical disk, magneto-optical disk, solid state disk, etc.), a compact disk (CD), a digital versatile disk (DVD), a floppy disk, a cartridge, a magnetic tape, and / or another type of computer-readable medium along with a corresponding drive.

[0151] The input components 310 may include components that enable the device 300 to receive information, such as via user input (e.g., a touchscreen display, a keyboard, a keypad, a mouse, buttons, switches, a microphone, a camera, an electroencephalogram (EEG) monitor, a patient monitoring system, etc.). Additionally or alternatively, the input components 310 may include sensors for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). The output components 312 may include components that provide output information from the device 300 (e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).

[0152] The communication interface 314 may include transceiver-like components (e.g., a transceiver, a separate receiver and transmitter, etc.) that enable the device 300 to communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. The communication interface 314 may enable the device 300 to receive information from and / or provide information to another device. For example, the communication interface 314 may include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi interface, a cellular network interface, etc.

[0153] The device 300 may perform one or more processes described herein. The device 300 may perform these processes based on the processor 304 executing software instructions stored by a computer-readable medium, such as the memory 306 and / or the storage component 308. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A non-transitory memory device includes a memory space located within a single physical storage device or a memory space spread across multiple physical storage devices.

[0154] Software instructions may be read into memory 306 and / or storage component 308 from another computer-readable medium or from another device via communications interface 314. When executed, the software instructions stored in memory 306 and / or storage component 308 may cause processor 304 to perform one or more operations described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more operations described herein. Thus, embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.

[0155] The memory 306 and / or storage component 308 may include data storage or one or more data structures (e.g., databases, etc.). The device 300 may be capable of receiving information from, storing information in, communicating information to, or retrieving information stored in the data storage or one or more data structures in the memory 306 and / or storage component 308. For example, the information may be input data, output data, medical data, or any combination thereof.

[0156] The number and configuration of components shown in Figure 3 are provided as an example. In some non-limiting embodiments or aspects, device 300 may include additional, fewer, different, or differently configured components than those shown in Figure 3. Additionally or alternatively, a set of components (e.g., one or more components) of device 300 may perform one or more functions described as being performed by another set of components of device 300.

[0157] FIG. 5A is a perspective view, and FIG. 5B is a top view, of a non-limiting embodiment or aspect of an implementation 500 of a smart device 104 including a needleless connector 214. Still referring to FIG. 4A, the needleless connector 214 may include a fluid flow path in a housing 402 between an inlet 404 and an outlet 406 opposite the inlet 404. The inlet 404 may be fluidically sealed by a displaceable septum 408 configured to be displaced to open or connect the inlet 404 to the fluid flow path in response to connection of the needleless connector 214 to a medical device (e.g., an infusion pump, an IV bag, a syringe, an IV line, etc.). Referring again to FIGS. 5A and 5B, in some non-limiting embodiments, the smart device 104 may include a sensor 254. For example, the sensor 254 may include a force sensor 502 connected to the needleless connector 214. By way of example, the force sensor 502 may be configured to sense, detect, and / or determine a force signal. In such examples, at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof may be determined based on the force signals (e.g., by the smart device 104, etc.). In such examples, a pattern of events including at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, a time between one or more detected events (e.g., a pause or connection time in which the needleless connector is connected to a medical device between a connection event and a disconnection event, etc.), or any combination thereof may be determined based on the force signals, and a medication administration event in which a medication is administered to a patient via the needleless connector 214 may be determined based on the pattern of events.As an example, standard of care may assume a rinse-flush-rinse-drug administration-rinse-flush-rinse pattern or sequence of events, and thus, the detection of three accesses of the luer connector may be interpreted by the smart device 104 as a drug administration event. For example, FIG. 5C is a graph 550 of a non-limiting embodiment or aspect of a force measurement or signal over time. As shown in FIG. 5C, pulsating flushing may be determined or detected by force measurements, for example, when flushing is accomplished by intermittent pulsations applied to the plunger of a flush syringe, and the smart device 104 can detect the occurrence of pulsating flushing by identifying a periodic force signal between x-y Hz in the force signal perpendicular to the plane of the septum 408 of the needleless connector 214. For example, the smart device 104 may determine a flushing event based on a force signal indicating a periodic force in a second direction that is perpendicular to a surface of the septum facing the first direction, and the flushing event includes a pulsatile flushing event.

[0158] In some non-limiting embodiments or aspects, the smart device 104 may further include communications circuitry configured to transmit the force signal to a remote computing system. For example, the medication source system 102, the central computing system 108, and / or the terminal / mobile computing system 110 may obtain the force signal from the smart device 104 and / or the needleless connector 214 and process the force signal to determine at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof.

[0159] In some non-limiting embodiments or aspects, the force sensor 502 includes at least one of a piezoelectric element, a force sensitive resistive film (FSR) sensor, a strain gauge, or any combination thereof. In some non-limiting embodiments or aspects, the force sensor 502 is located between the outer surface of an inner wall 510 (e.g., an inner, harder plastic wall) of the needleless connector 214 that defines the fluid flow path of the needleless connector 214 and the inner surface of an outer wall 512 (e.g., a softer, more flexible, more pliable, rubber, etc. wall) of the needleless connector 214 that surrounds the inner wall 510 of the needleless connector 214. In some non-limiting embodiments or aspects, the area between the outer surface of the inner wall 510 (e.g., a harder interior plastic wall) of the needleless connector 214 that defines the fluid flow path of the needleless connector 214, which may be held by a user during cleaning and / or connection to another medical device, and the inner surface of the outer wall 512 (e.g., a softer, more flexible, more pliable, rubber, etc. wall) of the needleless connector 214 that surrounds the inner wall 510 of the needleless connector 214, may be filled with rubber or other flexible type material 514 that includes a force sensor 502 as a force-sensing film within the material 514 between the inner wall 510 and the outer wall 512. In some non-limiting embodiments or aspects, the force sensor 502 may be located between the inner wall 510 and the outer wall 512 below the threads on and / or near the inlet 404 of the needleless connector 214.

[0160] In some non-limiting embodiments or aspects, the force sensors 502 include multiple force sensors 502 positioned around the fluid flow path of the needleless connector 214 between an outer surface of an inner wall 510 of the needleless connector 214 that defines the fluid flow path of the needleless connector 214 and an inner surface of an outer wall 512 of the needleless connector 214 that surrounds the inner wall 510 of the needleless connector 214. For example, the inlet 404 of the needleless connector 214 may include a septum 408 including a surface facing a first direction, and the force sensors 502 may be configured to detect a force in a second direction that is perpendicular to the surface of the septum facing the first direction. As an example, a flush event, which may include a pulsating flush event, may be determined based on a force signal indicative of a periodic force in the second direction that is perpendicular to the surface of the septum facing the first direction.

[0161] In some non-limiting embodiments or aspects, the sensor 254 includes a pressure sensor that is one of: in direct contact with the fluid in the fluid flow path of the needleless connector; located within an interior wall of the needleless connector that defines the fluid flow path of the needleless connector; or located within a wall of a lumen connected to the needleless connector. For example, the smart device 104 may determine or detect pulsatile flushing, flushing, and / or medication administration by a pressure sensor in contact with the fluid path in the needleless connector 214 and / or its lumen.

[0162] In some non-limiting embodiments or aspects, the sensor 254 includes an optical sensor configured to detect at least one of a color signature and a reflection of a medical device connected to and / or coupled to the needleless connector 214, and the smart device 104 may determine the type of medical device based on at least one of the color signature and the reflection of the medical device. For example, the color signature and / or reflection of the medical device may be indicative of a syringe, an IV bag, an infusion pump, and / or a particular type thereof.

[0163] In some non-limiting embodiments or aspects, sensor 254 includes an identification sensor configured to detect an identification tag on a medical device connected to or coupled to the needleless connector. For example, the identification sensor may include a magnetometer and the identification tag may include magnetic material on and / or integrated with needleless connector 214.

[0164] In some non-limiting embodiments or aspects, the sensor 254 includes a position sensor configured to detect movement of the needleless connector. For example, patient movement, a patient fall event, movement of the patient's bed can be determined (e.g., by the smart device 104, etc.) based on the detected movement of the needleless connector.

[0165] In some non-limiting embodiments or aspects, the sensor 254 includes an RGB color sensor configured to detect the color of the fluid in the fluid flow path of the needleless connector. For example, at least one of blood collection in the needleless connector and blood retention in the needleless connector can be determined based on the color of the fluid detected in the fluid flow path of the needleless connector (e.g., by the smart device 104, etc.).

[0166] In some non-limiting embodiments or aspects, the smart device 104 including the needleless connector 214 may include a visual indicator 252 that may be configured to provide a visual indication related to at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof. 6B , the smart device 104 may provide direct patient feedback (e.g., via LED illumination to a nurse, etc.) in response to (i) detecting that the needleless connector 214 and / or its lumen 212 have not been cleaned for a predetermined period of time and / or before a scheduled use, (ii) detecting that the needleless connector 214 and / or its lumen 212 have not been cleaned for a sufficient period of time before accessing the catheter line, (iii) detecting that flushing of the needleless connector 214 and / or lumen 212 is scheduled, (iv) detecting that a disinfection cap was not attached after a previous access of the needleless connector 214 and / or lumen 212, etc. For example, the smart device 104 may include the needleless connector 214, which may be configured to detect at least one of a cleaning event, a flushing event, a connecting or capping event, or any combination thereof. As an example, the needleless connector 214 may be configured to provide information and / or data related to a detected cleaning event, a detected flushing event, and / or a detected connecting or capping event (e.g., using the processor 304, memory 306, storage component 308, input component 310, output component 312, etc.) for storing the events and reporting compliance performance for monitoring compliance events.

[0167] 7 is a diagram of a non-limiting embodiment or aspect of a smart device implementation 700 for detecting drug extravasation or infiltration in a catheter. As shown in FIG. 7, the smart device 104 may be connected to or integrated with a needleless connector 214 at the catheter hub of a catheter 702 that includes a catheter lumen or line 704 and a needle tip 706 for delivering fluid to a patient at the opposite end of the catheter line 704 from the smart device 104. The catheter 702 may be inserted into a blood vessel (e.g., a vein, an artery, etc.) of the patient. For example, the location of the needle tip 706 may be within the patient's blood vessel, within the wall of the patient's blood vessel or urinary tract, or outside the patient's blood vessel or urinary tract and the wall of the blood vessel or urinary tract. In some non-limiting embodiments or aspects, the smart device 104 including the catheter 702 may include a wired and / or wireless transmitter configured to transmit (e.g., via a wire, wirelessly, etc.) at least one signal (and / or a variation in at least one signal over a period of time, the location of the needle tip relative to the patient's blood vessel or urinary tract, etc.) to a remote computer system or processing device. However, in some non-limiting embodiments or aspects, the catheter 702 may be configured for insertion into a blood vessel.

[0168] In some non-limiting embodiments or aspects, the smart device 104 may include a sensor 254 (e.g., as shown in FIG. 3 ) located outside the patient's body (e.g., at a needleless connector 214 of a hub of the catheter 702 located outside the patient's body, the sensor 254 may be connected to the hub of the catheter 702 outside the patient's body, etc.). For example, the sensor 254 may include at least one of a pressure sensor and an acoustic sensor (e.g., a piezoelectric transducer, etc.). As an example, the sensor 254 including a pressure sensor and / or an acoustic sensor may be connected to the needleless connector 214 of the hub of the catheter 702 outside the patient's body. 702 For example, the hub of the catheter 702 may be connected to a needleless connector. 214and / or smart device 104, and sensor 254 may be included in needleless connector 214. In such examples, sensor 254 may be configured to sense, detect, and / or measure pressure signals, acoustic signals, and / or time variations of pressure signals and / or acoustic signals using a catheter needle in the patient's body. For example, the pressure signal and / or acoustic signal sensed by sensor 254 may be transmitted through fluid in the catheter and / or through the material of the catheter (e.g., via needle tip 706, catheter lumen 704, needleless connector 214, etc.) for detection by sensor 254. As an example, if needle tip 706 punctures the wall of a patient's blood vessel or urinary tract, the pressure signal and / or acoustic signal sensed by sensor 254 may decrease or drop. In such examples, a decrease and / or absence of a pressure signal (e.g., a decreased amplitude of a heartbeat and / or a drop in blood pressure, etc.) may indicate an absence of a pressure signal associated with an absence of a blood pressure signal, thereby indicating an infiltration event.

[0169] In some non-limiting embodiments or aspects, the smart device 104 may be programmed and / or configured to compare a relatively slower change or variation in the pressure signal over time (e.g., a relatively slower decrease in heart rate amplitude and / or a drop in blood pressure, etc.) with a threshold level to determine an occlusion event rather than an infiltration or extravasation event. For example, an occlusion in the lumen may occur at a relatively slow rate over time (e.g., compared to an infiltration event, extravasation event, disconnection event, etc.), which results in a gradual change in the pressure signal sensed by the sensor 254. As an example, the smart device 104 may determine an occlusion event and provide an alert and / or automatically flush the lumen associated with the occlusion in response to detecting the occlusion event. In some non-limiting embodiments or aspects, the smart device 104 may detect a disconnection event in response to detecting a pressure signal substantially equal to atmospheric pressure by the sensor 254, which indicates connection of the catheter 702, e.g., the needleless connector 214 being disconnected therefrom and providing an alert to the user to address the connection. In some non-limiting embodiments or aspects, the smart device 104 may detect a kink in the catheter lumen 704 in response to detecting a pressure signal associated with the amplitude of the heartbeat dropping abruptly or immediately to zero, as opposed to an occlusion in the lumen, which may cause the amplitude of the heartbeat to drop at a relatively slower rate over time.

[0170] In some non-limiting embodiments or aspects, the smart device 104 can provide a location of the needle tip relative to the patient's blood vessel or urinary tract in real time according to the pressure signal and / or acoustic signal, thereby providing real-time feedback to the user as the catheter is being placed in the patient's blood vessel or urinary tract to indicate whether the catheter is properly positioned within the blood vessel or urinary tract or whether there is one of potential or existing fluid infiltration and potential or existing fluid extravasation. For example, the smart device 104 can determine the patient's heart rate, the patient's respiratory rate, the patient's blood pressure, the catheter needle penetration force, etc. according to the pressure signal and / or acoustic signal (e.g., based on fluid pressure due to fluid entering the catheter path of the smart device 104, etc.). As an example, the smart device 104 can provide an indication of the penetration of the needle tip into the patient's blood vessel or urinary tract in real time according to the pressure signal and / or acoustic signal.

[0171] 8, which is a flowchart of a non-limiting embodiment or aspect of a process 800 for identifying a lumen. In some non-limiting embodiments or aspects, one or more of the steps of process 800 are performed (e.g., completely, partially, etc.) by drug source system 102 (e.g., one or more devices of drug source system 102, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 800 are performed (e.g., completely, partially, etc.) by another device or group of devices separate from or including drug source system 102, such as smart device 104 (e.g., one or more devices of the system of smart device 104, etc.), central computing system 108 (e.g., one or more devices of central computing system 108, etc.), and / or terminal / mobile computing system 110 (e.g., one or more devices of terminal / mobile computing system 110, etc.).

[0172] 8, at step 802, the process 800 includes obtaining a user input associated with a drug source device. For example, the drug source system 102 may obtain the user input associated with the drug source device 206. As an example, the drug source system 102 may obtain (e.g., receive, retrieve, determine, etc.) the user input received via a user input component of the drug source device 206 (e.g., via the pairing input 208, etc.). In such an example, the drug source system 102 may receive data associated with the user input from the drug source device 206.

[0173] 2A , in some non-limiting embodiments or aspects, multiple drug source devices 206a, 206b, ... 206n of the drug source system 102 are connected to multiple lumens 212a, 212b, ... 212n, and each drug source 206 device may include a visual indicator 210, a communication circuit (e.g., communication interface 314, etc.), and a pairing input 208. In some non-limiting embodiments or aspects, the drug source device 206 receives user input via the pairing input 208 of the drug source device 206. For example, the visual indicator 210 may emit a predetermined light pattern (e.g., rapidly blink and / or emit a predetermined color to indicate that the drug source device 206 is in pairing mode) in response to a predetermined user input to the pairing input 208 of the drug source device 206 (e.g., in response to a user pressing and holding a button on the pairing input 208, etc.).

[0174] 8, at step 804, the process 800 includes acquiring user input associated with the smart device. For example, the drug source system 102 may acquire user input associated with the smart device 104. As an example, the drug source system 102 may acquire (e.g., receive, retrieve, determine, etc.) the user input received via a user input component (e.g., pairing input 256, etc.) of the smart device 104. In such an example, the drug source system 102 may receive data associated with the user input from the smart device 104 that is received at the same time that the drug source device 206 is in pairing mode.

[0175] 2A and 2B, in some non-limiting embodiments or aspects, multiple smart devices 104a, 104b, ... 104n may be connected (e.g., removably connected, etc.) or configured to be connected to multiple lumens 212a, 212b, ... 212n, and each smart device 104 may include a visual indicator 252, a communication circuit (e.g., a communication interface 314, etc.), and a pairing input 256. In some non-limiting embodiments or aspects, the smart device 104 receives user input via the pairing input 256 of the smart device 104. For example, the smart device 104 may establish communication with the drug source device 206 (e.g., pair the drug source device 206 with the smart device 104 and / or activate / initiate a pairing sequence for pairing therewith) in response to a predetermined user input to the pairing input 256 of the smart device 104 (e.g., in response to a user pressing and holding a button on the pairing input 256) at the same time that the drug source device 206 is in pairing mode.

[0176] 8 , in step 806, process 800 includes establishing communication between the drug source device and the smart device. For example, drug source system 102 may establish communication between drug source device 206 and smart device 104. As an example, drug source system 102 may establish communication between drug source device 206 and smart device 104 (e.g., an NFC communication connection, an RFID communication connection, a Bluetooth® communication connection, etc.). In such an example, communication circuitry of smart device 104 and communication circuitry of drug source device 206 may establish communication (e.g., a pair, etc.) between smart device 104 and drug source device 206 based on user input received by pairing input 208 of drug source device 206 and user input received by pairing input 256 of smart device 104. For example, drug source device 206 may establish a short-range wireless communication connection (e.g., an NFC communication connection, an RFID communication connection, a Bluetooth® communication connection, etc.) with smart device 104. As an example, the visual indicator 210 may be configured to emit a predetermined light pattern (e.g., to blink rapidly to indicate that the drug source device 206 is in pairing mode, etc.) in response to a predetermined user input to the pairing input 208 of the drug source device 206 (e.g., in response to a user pressing and holding a button on the pairing input 208, etc.). In such an example, the smart device 104 may be configured to establish communication with the drug source device 206 (e.g., to pair the drug source device 206 with the smart device 104 and / or activate a pairing sequence for pairing therewith, etc.) in response to a predetermined user input to the pairing input 256 of the smart device 104 (e.g., in response to a user pressing and holding a button on the pairing input 256, etc.) at the same time that the drug source device 206 is in pairing mode.

[0177] 8 , in step 808, process 800 includes controlling the visual indicators of the drug source device and the smart device to generate the same type of visual output. For example, drug source system 102 may control visual indicator 210 of drug source device 206 and visual indicator 252 of smart device 104 to generate the same type of visual output. As an example, drug source system 102 may control visual indicator 210 (e.g., a multi-colored LED, etc.) of drug source device 206 and visual indicator 252 (e.g., a multi-colored LED, etc.) of smart device 104 to generate the same type of visual output (e.g., light of the same color, etc.) based on communication established between the drug source device and the smart device.

[0178] In some non-limiting embodiments or aspects, when the smart device 104 is paired with the drug source device 206, the drug source device 206 may illuminate the visual indicator 210 in a color not previously used in the drug source system 102 (e.g., a color not associated with another drug source device 206 and another smart device 104 paired in the drug source system 102, a color different from each of the other colors of light generated by each of the other smart devices 104 of the multiple smart devices 104a, 104b, ... 104n and each of the other drug source devices 206 of the multiple drug source devices 206a, 206b, ... 206n in the drug source system 102, etc.), and the smart device 104 may illuminate the visual indicator 252 in the same color as the visual indicator 210 (e.g., the drug source system 102, the drug source device 206, the smart device 104, etc. may control the visual indicator 252 to illuminate in the same color as the visual indicator 210). In some non-limiting embodiments or aspects, the smart device 104 may illuminate the visual indicator 252 the same color as the visual indicator 210 in response to the smart device 104 being connected to the lumen and / or during the period of time that the smart device 104 is connected to the lumen. For example, the smart device 104 may automatically stop illuminating the visual indicator 252 the same color as the visual indicator 210 (e.g., turning off the LED, setting the LED to a default color indicative of an unpaired smart device 104, etc.) in response to the smart device 104 being disconnected from the lumen. As an example, the smart device 104 may include a switch connected to the visual indicator 252 configured to be activated / deactivated in response to a clamp or other connection means being connected / disconnected from the lumen and / or its needleless connector 214.

[0179] In some non-limiting embodiments or aspects, the drug source system 102 determines the same color of light color for the visual indicator 252 of the smart device 104 and the visual indicator 210 of the drug source device 206 to generate based on at least one of a user input received by the pairing input 208 of the drug source device 206 and a user input received by the pairing input 256 of the smart device 104. For example, after the smart device 104 is paired with the drug source device 206, a user may actuate the pairing input 208 and / or the pairing input 256 to cycle through the colors of light available for pairing to select a desired (and / or available or previously unused) color of light for pairing.

[0180] 8 , in step 810, the process 800 includes associating the same type of visual output with the same lumen. For example, the drug source system 102 may associate (e.g., automatically associate, etc.) the same type of visual output with the same lumen. As an example, the drug source system 102 may associate (e.g., store with, pair, link, illuminate with, etc.) the same type of visual output (e.g., the same color light, etc.) with the same lumen (e.g., the same lumen of multiple lumens 212a, 212b, ... 212n, etc.). In such an example, the drug source device 206 and the smart device 104 may be connected to the same lumen. Thus, a user may more easily identify the lumen or line, the location of the lumen or line, the drug that was or is being delivered through the lumen or line, which infusion pump or line the lumen or line is connected to, etc.

[0181] In some non-limiting embodiments or aspects, the drug source system 102 may obtain a user input received by a user input component of the other drug source device, obtain a user input received by a user input component of the other smart device, establish communication between the other drug source device and the other smart device based on the user input received by the user input component of the other drug source device and the user input received by the user input component of the other smart device, and control a visual indicator of the other smart device and a visual indicator of the other drug source device to generate another same type of visual output based on the communication established between the other drug source device and the other smart device, wherein the another same type of visual output is different from the same type of visual output and / or associates the another same type of visual output with another same lumen of the multiple lumens, wherein the other drug source device is connected to the another same lumen. For example, referring again to FIG. 2A, drug source device 206a may be paired with smart device 104n, where drug source device 206a and smart device 104n may each output light of a first color associated with lumen 212a (e.g., red light); drug source device 206b may be paired with smart device 104a, where drug source device 206b and smart device 104a may each output light of a second color associated with lumen 21b (e.g., green light); drug source device 206n may be paired with smart device 104b, where drug source device 206n and smart device 104b may each output light of a third color associated with lumen 212n (e.g., blue light); and so on.

[0182] 8, in step 812, the process 800 includes identifying the lumens. For example, the drug source system 102 may identify the lumens. As an example, the drug source system 102 may identify the same lumens associated with the same type of visual output.

[0183] In some non-limiting embodiments or aspects, the medication source system 102 identifies lumens by automatically associating and / or providing medical data with the same type of visual output associated with the lumen and / or lumen identifier. For example, the medical data may include patient data (e.g., an identifier for a particular patient, information and / or data related to the patient, etc.), medication source data (e.g., an identifier for a particular medication source device 206, etc.), medication data (e.g., an identifier for a type of medication, scheduled delivery of a particular medication, previous delivery of a particular medication, a lumen associated with the medication, etc.), lumen data (e.g., an identifier for a particular lumen, such as an identifier for the same lumen associated with the same type of visual output, etc.), sensor data (e.g., an identifier for a particular sensor 254, information, data, and / or signals sensed, measured, and / or detected by one or more sensors 254 in one or more smart devices 104, etc.), compliance data (e.g., information or data related to a cleaning event in which the needleless connector 214 and / or lumen are cleaned with a disinfectant, information or data related to the needleless connector 214, etc.), or the like. The information or data may include at least one of: information or data related to a flushing event in which the needleless connector 214 and / or lumen is flushed with a solution, information or data related to a connecting or capping event in which the needleless connector 214 or lumen is connected to a medical device, location data (e.g., patient location, location of a previous or scheduled fluid delivery procedure, location of the lumen, location of a drug source device, etc.); time data (e.g., time related to a previous or scheduled fluid delivery procedure, time of connection of the lumen to the drug source device 206, time of connection of the smart device 104 to the lumen, time of pairing of the drug source device 206 and smart device 104, etc.); location of the catheter needle tip of the lumen relative to the patient's blood vessel or urinary tract; or any combination thereof.As an example, the drug source system 102 may obtain medical data from the smart device 104, the central computing system 108, the terminal / mobile computing system 110, one or more databases connected thereto, and / or one or more sensors connected thereto (e.g., a barcode sensor for scanning an identifier for patient identification, a fluid flow sensor for sensing fluid flow, a drug type sensor for sensing a type of drug, etc.). In such an example, the drug source system 102 may identify a lumen having information and / or data associated therewith and provide a visual indication of which lumen of the plurality of lumens 212a, 212b, ... 212n is connected to which drug source device of the plurality of drug source devices 206a, 206b, ... 206n, allowing a user to more easily track a lumen from the patient to the particular drug source device to which it is connected and to more easily reattach the correct drug source device channel to the correct (e.g., the same as before) lumen. With the same type of visual indicator used for the source device pair, it can be possible to enable a connection between the lumen and the drug source device to be removed when the patient is moved (e.g., to a new room, new floor, operating room, bathroom, etc.), to track compliance with best protocols by determining, for example, whether the hub has been cleaned and whether the hub has been cleaned effectively (e.g., enough pressure, cleaned for enough time, etc.), and / or whether the device has been flushed, maintained, etc., to provide reminders and prescriptive help for protocol compliance, etc.

[0184] In some non-limiting embodiments or aspects, the drug source system 102 identifies the lumen by determining and providing one or more alerts or reminders associated with the lumen and / or the same type of visual output associated with the lumen based on the medical data, such as a reminder to flush the lumen and / or its needleless connector 214, a reminder to remove or replace the lumen, BD MedMined™ infection prevention guidance (e.g., identifying and reporting healthcare-associated infections (HAIs), using customized alerts and reports to facilitate timely patient intervention, etc.), an alert to use a different lumen for delivery of a particular drug to reduce the likelihood of chemical blockage formation, an alert indicating whether the lumen should be treated for thrombotic or chemical blockage, an alert that an obstruction has been detected in the lumen, an alert in which the location of the tip of a needle connected to the lumen is associated with one of potential or existing fluid infiltration and potential or existing fluid extravasation, etc.

[0185] In some non-limiting embodiments or aspects, the drug source system 102 identifies the lumen by controlling the drug source device 206 or another medical device (e.g., an electronic valve, etc.) based on medical data to inhibit or prevent the delivery of fluid (e.g., a particular drug, a type of drug, etc.) through the lumen.

[0186] Further details regarding a non-limiting embodiment or aspect of process 800 are provided below with respect to FIG.

[0187] 9, which is a flowchart of a non-limiting embodiment or aspect of a process 900 for identifying a lumen. In some non-limiting embodiments or aspects, one or more of the steps of process 900 are performed (e.g., completely, partially, etc.) by drug source system 102 (e.g., one or more devices of drug source system 102, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 900 are performed (e.g., completely, partially, etc.) by another device or group of devices separate from or including drug source system 102, such as smart device 104 (e.g., one or more devices of the system of smart device 104, etc.), central computing system 108 (e.g., one or more devices of central computing system 108, etc.), and / or terminal / mobile computing system 110 (e.g., one or more devices such as terminal / mobile computing system 110, etc.).

[0188] 9, at step 902, process 900 includes acquiring medication data. For example, medication source system 102 may acquire the medication data. As an example, medication source system 102 may acquire medication data associated with a first type of medication delivered or scheduled to be delivered to a patient through the same lumen and a second type of medication delivered or scheduled to be delivered to a patient through the same lumen. In such an example, the first type of medication may be different from the second type of medication.

[0189] In certain non-limiting embodiments or aspects, the medication data is associated with at least one of an identifier of the type of medication, a scheduled delivery of the medication via a particular medication source device and / or lumen, a previous delivery of the medication via a particular medication source device and / or lumen, an amount of the medication, an identifier of a patient for whom the medication is scheduled to be delivered (or to whom it has been delivered), one or more identifiers of one or more different types of medications that are not compatible for delivery via the same lumen as the medication, and the like.

[0190] 9, in step 904, process 900 includes determining compatibility of the medications. For example, medication source system 102 may determine compatibility of the medications. As an example, medication source system 102 may determine compatibility of a second type of medication for delivery through the same lumen as a first type of medication based on the medication data.

[0191] In some non-limiting embodiments or aspects, the drug source system 102 may use the identifier of the first type of drug and / or the identifier of the second type of drug to access a lookup table that indicates whether the first type of drug and the second type of drug are compatible or incompatible (e.g., compatible or incompatible for delivery via the same lumen, etc.). In some non-limiting embodiments or aspects, the lookup table may be stored in and / or associated with the identifier of the first type of drug and / or the identifier of the second type of drug.

[0192] In certain non-limiting embodiments or aspects, the drug source device 206may obtain medication data related to a third type of medication delivered or scheduled to be delivered to the patient through another same lumen (e.g., different from the same lumen), and determine, based on the medication data, suitability of the second type of medication for delivery through the same other lumen as the third type of medication, wherein the indication further indicates whether the second type of medication is compatible for delivery through another same lumen associated with another same type of visual output. For example, referring again to FIGS. 2A and 2B, the medication source device may indicate that the second type of medication is not compatible for delivery through the first lumen 212a. 206 If determined, the drug source device 206 may determine the suitability of the second type of agent for delivery through an alternative lumen, such as the second lumen 212b, based on the third type of agent delivered or scheduled to be delivered through the second lumen 212b, and may provide an indication that the second type of agent is suitable for delivery through the second lumen 212b if the second type of agent is suitable for delivery through the same lumen as the third type of agent.

[0193] 9, in step 906, the process 900 includes providing an indication of compatibility. For example, the drug source system 102 may provide an indication of compatibility. As one example, the drug source system 102 may provide an indication of whether a second type of drug is compatible for delivery through the same lumen associated with the same type of visual output. As another example, the drug source system 102 may provide an indication of whether a third type of drug is compatible for delivery through another same lumen associated with another same visual output.

[0194] In some non-limiting embodiments or aspects, the drug source system 102 may provide an indication of compatibility by controlling the drug source device 206 to inhibit or prevent delivery of a second drug through the same lumen associated with the same type of visual output. For example, a first type of drug may be delivered to a patient with the same lumen associated with the same type of visual output, and a second type of drug may be scheduled for delivery to the patient through the same lumen. By way of example, and again referring to FIGS. 2A and 2B , the drug source system 102 may determine, based on the medical data including the drug data, that a first type of drug is delivered to the patient through lumen 212a and a second type of drug scheduled or attempting to be delivered through the same lumen 212a is incompatible with the first type of drug (e.g., may cause a blockage, may cause an adverse drug reaction in the patient, etc.). In such an example, the drug source system 102 may control the drug source device 206a to inhibit or prevent (e.g., by stopping the pump, closing a valve, etc.) delivery of a second drug through the same lumen 212a and / or prompting the user to use another lumen (e.g., 212b, ... 212n, etc.) associated with a different type of visual output than the same type of visual output to deliver a second type of drug to the patient.

[0195] In some non-limiting embodiments or aspects, a first type of agent and a second type of agent may be delivered to a patient through the same lumen associated with the same type of visual output, and the agent source system 102 may prompt a user to treat the same lumen associated with the same type of visual output for one of a thrombotic occlusion and a chemical occlusion. For example, when an occlusion occurs that may be detected by the agent source system 102 as described herein, a user (e.g., a nurse, etc.) may need to determine whether the occlusion is thrombotic or chemical due to a drug interaction, and the agent source system 102 can determine which agent was delivered through which lumen to inform the user about the history of the lumen and / or provide an indication of the potential cause of the occlusion, thereby enabling an accurate determination as to whether the lumen should be treated for a thrombotic occlusion or a chemical occlusion. In some non-limiting embodiments or aspects, the drug source system 102 may control the drug source device 206 to automatically perform a flushing operation to deliver flushing fluid to a lumen connected to the drug source device 206 in response to determining that the blockage in the lumen is a chemical blockage.

[0196] 10, which is a flowchart of a non-limiting embodiment or aspect of a process 1000 for locating a needle tip. In some non-limiting embodiments or aspects, one or more of the steps of process 1000 are performed (e.g., completely, partially, etc.) by smart device 104 (e.g., one or more devices in the system of smart device 104, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 1000 are performed (e.g., completely, partially, etc.) by another device or group of devices separate from or including smart device 104, such as drug source system 102 (e.g., one or more devices in the system of drug source system 102), central computing system 108 (e.g., one or more devices in the central computing system 108), and / or terminal / mobile computing system 110 (e.g., one or more devices such as terminal / mobile computing system 110, etc.).

[0197] 10, in step 1002, the process 1000 includes acquiring a signal including at least one of a pressure signal and an acoustic signal. For example, the smart device 104 may acquire the signal including at least one of a pressure signal and an acoustic signal from at least one sensor connected to the catheter. As an example, the smart device 104 may acquire at least one signal including at least one of a pressure signal and an acoustic signal from a sensor 254 connected to the catheter 702 (e.g., from a pressure sensor, from an acoustic sensor, etc.). In some non-limiting embodiments or aspects, and referring to FIG. 7, the catheter 702 includes a needle having a tip 706 for delivering fluid to the patient.

[0198] In some non-limiting embodiments or aspects, the sensor 254 measures at least one signal including at least one of a pressure signal and an acoustic signal. For example, the sensor 254 may measure at least one signal including at least one of a pressure signal and an acoustic signal, and the smart device 104 (and / or the drug source system 102, the central computing system 108, and / or the terminal / mobile computing system 110) may obtain the at least one signal including at least one of the pressure signal and the acoustic signal from the sensor 254. For example, the smart device 104 may include communication circuitry (e.g., communication interface 314, etc.) that wirelessly transmits the at least one signal to a remote computing system. As an example, the smart device 104 may process the pressure and / or acoustic signals on a microprocessor within the housing of the smart device 104 that contains the sensor 254 and the microprocessor, and / or the smart device 104 may wirelessly transmit (and / or transmit via a wired connection) the pressure and / or acoustic signals to a remote computer that performs digital signal processing on the pressure and / or acoustic signals to identify and classify events of interest (e.g., infiltration, extravasation, catheter occlusion, etc.).

[0199] 10, in step 1004, the process 1000 includes determining the location of the catheter needle tip relative to the patient's blood vessel or urinary tract. For example, the smart device 104 may determine the location of the needle tip relative to the patient's blood vessel or urinary tract. As an example, the smart device 104 may determine the location of the needle tip 706 relative to the patient's blood vessel or urinary tract based on the variation of at least one signal over a period of time.

[0200] In some non-limiting embodiments or aspects, the location of the needle tip 706 is determined as one of within a blood vessel or urinary tract, within a wall of a blood vessel or urinary tract, and outside the blood vessel or urinary tract and the wall of the blood vessel or urinary tract. In some non-limiting embodiments or aspects, the smart device 104 and / or one or more components thereof may be connected to or included within (e.g., integrated with) a needleless connector 214 at a catheter hub of the catheter 702 located outside the patient's body. For example, the sensor 254 (e.g., a pressure sensor, an acoustic sensor, etc.) of the smart device 104 may measure at least one signal including at least one of a pressure signal and an acoustic signal, wherein the catheter includes a needle having a tip for delivering fluid to the patient.

[0201] In some non-limiting embodiments or aspects, the smart device 104 determines that the location of the needle tip 706 is associated with one of potential or existing infiltration of fluid and potential or existing extravasation of fluid. For example, the sensor 254 (e.g., one or more pressure sensors, one or more acoustic sensors, etc.) may detect time variations in pressure and / or acoustic signals resulting from the needle tip 706 of the catheter 702 being properly inserted into a blood vessel or urinary tract, being located in the wall of the blood vessel or urinary tract, being located outside the blood vessel or urinary tract, etc. As an example, the smart device 104 may compare variations in at least one signal over a period of time to a threshold variation associated with the patient's heartbeat. For example, variations in the pressure and / or acoustic signals may be associated with pressure and / or acoustic fluctuations in the blood vessel or urinary tract as a result of the patient's heartbeat. As one example, the smart device 104 may compare fluctuations in the detected pressure signal and / or the detected acoustic signal with fluctuations in the pressure signal and / or the acoustic signal associated with the patient's heartbeat to determine whether the needle tip 706 of the catheter 702 is properly positioned within the patient's blood vessel (e.g., artery, vein, etc.). In such an example, if the needle tip 706 of the catheter 702 overshoots the tract or urinary tract (e.g., puncturing the wall of the blood vessel or urinary tract, not properly within the blood vessel or urinary tract, etc.), the pressure and / or acoustic signature of at least one signal measured by the sensor 254 changes. In some non-limiting embodiments or aspects, infiltration or extravasation of a drug into tissue surrounding a blood vessel or urinary tract (rather than within the blood vessel or urinary tract) may result in a characteristic pressure or acoustic signal being detected by the sensor 254 depending on the effect of the infiltration or extravasation on the surrounding tissue (e.g., if the extravasating drug is a strong vesicant, such effect may be severe, etc.).

[0202] In some non-limiting embodiments or aspects, the smart device 104 determines at least one of an occlusion of the catheter and a disconnection of the catheter from the needleless connector based on a variation in the at least one signal over a period of time. For example, the smart device 104 may compare the variation in the at least one signal over a period of time to a threshold period of time associated with the formation of an occlusion in the catheter. As an example, the smart device 104 may compare a relatively slower change or variation in the pressure signal over time (e.g., a relatively slower decrease in heartbeat amplitude and / or a drop in blood pressure compared to an occlusion or an extravasation event, etc.) to a threshold level to determine an occlusion event rather than an infiltration or extravasation event. For example, an occlusion in the lumen may occur at a relatively slow rate over time (e.g., compared to an infiltration event, an extravasation event, a disconnection event, etc.), which may result in a gradual change in the pressure signal sensed by the sensor 254. As an example, the smart device 104 may determine an occlusion event and provide an alert and / or automatically flush the lumen associated with the occlusion in response to detecting the occlusion event. In some non-limiting embodiments, the smart device 104 may detect a disconnection event in response to detecting a pressure signal substantially equal to atmospheric pressure by the sensor 254, which indicates a connection of the catheter 702, e.g., the needleless connector 214, therefrom, and alerts the user to address the connection.

[0203] 10, in step 1006, the process 1000 includes providing a location of the needle tip. For example, the smart device 104 may provide the location of the needle tip. As an example, the smart device 104 may provide the location of the needle tip 706 relative to a blood vessel or urinary tract of the patient.

[0204] In some non-limiting embodiments or aspects, the smart device 104 controls the alert device to issue an alert related to one of a potential or existing infiltration of fluid and a potential or existing extravasation of fluid. For example, the smart device 104 controls the visual indicator 252 of the smart device 104 to output a light color and / or pattern related to one of a potential or existing infiltration of fluid and a potential or existing extravasation of fluid. As an example, in response to determining an event as an infiltration, extravasation, or catheter blockage, the smart device 104 may flash an alert light to a user (e.g., a clinician, a caregiver, a family member, another patient at home or in an assisted living environment, etc.) and / or send a signal to a remote computing system (e.g., the medication source system 102, the central computing system 108, the terminal / mobile computing system 110, etc.) to control (e.g., trigger) the output of an audio and / or visual alarm at the remote computing system to alert appropriate individuals about the determined event.

[0205] In some non-limiting embodiments or aspects, the smart device 104 controls the drug source device 206 or a valve (e.g., a valve controlling fluid delivery to or from the catheter 702, etc.) to stop (e.g., inhibit, prevent, etc.) fluid delivery to and / or from the catheter. As an example, in response to determining an event as infiltration, extravasation, catheter obstruction, or catheter disconnection, the smart device 104 may signal an infusion device to immediately stop drug infusion or signal a valve or mechanical clamp to block further drug from being infused into the catheter and / or patient.

[0206] In some non-limiting embodiments or aspects, the smart device 104 and / or the needleless catheter may include communication circuitry (e.g., communication interface 314, etc.) that wirelessly transmits at least one signal to a remote computing system. As an example, the smart device 104 and / or the needleless connector 214 may process the pressure and / or acoustic signals on a microprocessor within the housing 250 of the smart device 104 and / or within the housing 250 of the needleless connector 214, which includes the sensor 254 and the microprocessor, and / or the smart device 104 and / or the needleless connector 214 may wirelessly transmit (and / or transmit via a wired connection) the pressure and / or acoustic signals to a remote computer that performs digital signal processing on the pressure and / or acoustic signals to identify and classify events of interest (e.g., infiltration, extravasation, catheter obstruction, catheter disconnection, etc.).

[0207] In some non-limiting embodiments or aspects, the smart device 104 may provide real-time feedback during catheter insertion (e.g., via the visual indicator 252, the output component 312, the drug source system 102, etc.) so that a clinician or other person may be alerted as to whether the catheter 702 is properly inserted and / or whether the needle tip 706 of the catheter 702 has penetrated or is in the process of penetrating a blood vessel or urinary tract and / or whether it has been accidentally cut or occluded.

[0208] 11 is a flowchart of a non-limiting embodiment or aspect of a process 1100 for monitoring for matching events. In some non-limiting embodiments or aspects, one or more of the steps of process 1100 are performed (e.g., completely, partially, etc.) by smart device 104 (e.g., one or more devices in the system of smart device 104, etc.). In some non-limiting embodiments or aspects, one or more of the steps of process 1100 are performed (e.g., completely, partially, etc.) by another device or group of devices separate from or including the smart device, such as medication source system 102 (e.g., one or more devices in the system of medication source system 102), central computing system 108 (e.g., one or more devices in the central computing system 108, etc.), and / or terminal / mobile computing system 110 (e.g., one or more devices such as terminal / mobile computing system 110, etc.).

[0209] 11, in step 1102, the process 1100 includes acquiring a signal. For example, the smart device 104 may acquire the signal. As an example, the smart device 104 may acquire a signal (e.g., a force signal, an optical signal, a flow signal, an acoustic signal, a sound signature, a signal related to septum movement, a signal other than a force signal such as a pressure signal, etc.) measured by a sensor 254 (e.g., a force sensor, an optical sensor, a flow sensor, an acoustic sensor, a pressure sensor, etc.) connected to the needleless connector 214 including the fluid flow path. In such an example, the sensor 254 may measure the signal using a sensor connected to the needleless connector including the fluid flow path, and the smart device 104 (and / or the drug source system 101, the central computing system 108, the terminal / mobile computing system 110 ) may obtain a signal from the sensor 254.

[0210] In some non-limiting embodiments or aspects, signals acquired by the smart device 104 may include instantaneous, static, or measurements of values ​​at a single point in time (e.g., force, pressure, sound, vibration, reflection, etc., at a single point in time). In some non-limiting embodiments or aspects, signals acquired by the smart device 104 may include dynamic or time-varying signals (e.g., measurements of values ​​over a time period, etc.). For example, time-varying forces, pressures, stresses, strains, etc. may include low-frequency signals, such as signals that vary at subaudible frequencies (e.g., 20 Hz or less), and / or may include signals in the acoustic range that travel as sound waves propagating through solids, liquids, and / or air. As described in more detail herein with respect to the sensors 254, time-varying signals may be measured using force sensors, seismometers, pressure sensors, optical sensors, microphones, acoustic sensors for atmospheric waves in the audible range, hydrophones, acoustic sensors for liquid waves, pickups or transducers that capture or sense mechanical vibrations, or any combination thereof.

[0211] 11 , in step 1104, the process 1100 includes determining an event associated with the needleless connector based on the signal. For example, the smart device 104 may determine an event associated with the needleless connector 214 based on the signal. As an example, the smart device 104 may determine at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof based on the signal (e.g., a force signal, an optical signal, a flow signal, an acoustic signal, a sound signature, a signal other than a force signal such as a pressure signal, etc.).

[0212] In some non-limiting embodiments or aspects, the sensor 254 may include a force sensor 502. In some non-limiting embodiments or aspects, the force sensor 502 includes at least one of a piezoelectric element, a force sensitive resistive film (FSR) sensor, a strain gauge, or any combination thereof. In some non-limiting embodiments or aspects, the force sensor 502 is located between the outer surface of an inner wall 510 (e.g., an inner, harder plastic wall) of the needleless connector 214 that defines the fluid flow path of the needleless connector 214 and the inner surface of an outer wall 512 (e.g., a softer, more flexible, more pliable, rubber, etc. wall) of the needleless connector 214 that surrounds the inner wall 510 of the needleless connector 214. In some non-limiting embodiments or aspects, the area between the outer surface of the inner wall 510 (e.g., a harder interior plastic wall) of the needleless connector 214 that defines the fluid flow path of the needleless connector 214, which may be held by a user during cleaning and / or connection to another medical device, and the inner surface of the outer wall 512 (e.g., a softer, more flexible, more pliable, rubber, etc. wall) of the needleless connector 214 that surrounds the inner wall 510 of the needleless connector 214, may be filled with rubber or other flexible type material 514 that includes a force sensor 502 as a force-sensing film within the material 514 between the inner wall 510 and the outer wall 512. In some non-limiting embodiments or aspects, the force sensor 502 may be located between the inner wall 510 and the outer wall 512 below the threads on and / or near the inlet 404 of the needleless connector 214.

[0213] In some non-limiting embodiments or aspects, the force sensors 502 include multiple force sensors 502 positioned around the fluid flow path of the needleless connector 214 between an outer surface of an inner wall 510 of the needleless connector 214 that defines the fluid flow path of the needleless connector 214 and an inner surface of an outer wall 512 of the needleless connector 214 that surrounds the inner wall 510 of the needleless connector 214. For example, the inlet 404 of the needleless connector 214 may include a septum 408 including a surface facing a first direction, and the force sensors 502 may be configured to detect a force in a second direction that is perpendicular to the surface of the septum facing the first direction. As an example, a flush event, which may include a pulsating flush event, may be determined based on a force signal indicative of a periodic force in the second direction that is perpendicular to the surface of the septum facing the first direction.

[0214] In some non-limiting embodiments or aspects, the sensor 254 includes a pressure sensor that is one of: in direct contact with the fluid in the fluid flow path of the needleless connector; located within an interior wall of the needleless connector that defines the fluid flow path of the needleless connector; or located within a wall of a lumen connected to the needleless connector. For example, the smart device 104 may determine or detect pulsatile flushing, flushing, and / or medication administration by a pressure sensor in contact with the fluid path in the needleless connector 214 and / or its lumen.

[0215] In some non-limiting embodiments or aspects, the pressure sensor may be configured to sense pressure transmitted through at least one of a fluid in the catheter and a material of the catheter. For example, referring again to FIG. 7 , the needleless connector 214 may be connected to a catheter hub of a catheter 702 that includes a catheter lumen 704 and a needle tip 706 for delivering fluid from the catheter hub to a patient at an opposite end of the catheter lumen 704. As an example, the pressure sensor may be connected to the needleless connector 214 to sense pressure. In such an example, the smart device 104 may receive a signal related to the sensed pressure from the pressure sensor and determine an event related to the catheter 702 based on the signal.

[0216] In some non-limiting embodiments or aspects, the event associated with the catheter 702 includes a time when the needle tip 706 of the catheter 702 entered a patient's blood vessel. For example, the smart device 104 may determine the time when the needle tip 706 of the catheter 702 entered a blood vessel based on at least one of a heart rate, a respiratory rate, a blood pressure, a penetration force of the needle tip 706 determined from a signal related to the sensed pressure, or any combination thereof.

[0217] In some non-limiting embodiments or aspects, the event associated with the catheter 702 includes a clamping sequence, and the smart device 104 may determine the clamping sequence based on one or more changes over time in the sensed pressure-related signal. In such an example, the smart device 104 may determine, based on the determined clamping sequence and the type of needleless connector 214 (e.g., a neutral displacement connector, a positive pressure displacement connector, a negative pressure displacement connector, etc.), whether the determined clamping sequence satisfies a clamping protocol associated with the type of needleless connector 214. For example, different types of needleless connectors 214 (e.g., a neutral displacement connector, a positive pressure displacement connector, a negative pressure displacement connector, etc.) may be associated with different clamping protocols recommended to be performed during a connection event and / or a disconnection event to reduce or prevent backflow into the catheter 702. As an example, failure to follow the clamping protocol associated with the type of needleless connector 214 connected to the catheter 702 may result in a patient infection due to an occlusion in the catheter 702 or backflow into the catheter 702. Thus, the smart device 104 may reduce or prevent such blockages and / or infections by monitoring whether the user performs the recommended clamping protocol associated with the particular type of needleless connector 214 connected to the catheter 702.

[0218] In some non-limiting embodiments or aspects, the event associated with the catheter 702 includes an occlusion of the catheter lumen 704, and the smart device 104 may determine an occlusion of the catheter lumen 704 based on a rate of change of the sensed pressure contained in the signal from the pressure sensor. For example, the smart device 104 may be programmed and / or configured to compare a relatively slower change or variation in the pressure signal over time (e.g., a relatively slower decrease in heartbeat amplitude and / or a drop in blood pressure, etc.) with a threshold level to determine an occlusion event rather than an infiltration or extravasation event. For example, an occlusion in the lumen may occur at a relatively slow rate over time (e.g., compared to an infiltration event, extravasation event, disconnection event, etc.), which results in a gradual change in the pressure signal sensed by the sensor 254. As an example, the smart device 104 may determine an occlusion event and provide an alert and / or automatically flush the lumen associated with the occlusion in response to detecting the occlusion event. In such an example, the smart device 104 may detect a kink in the catheter lumen 704 in response to detecting a pressure signal associated with the amplitude of the heartbeat dropping suddenly or immediately to zero, as opposed to an occlusion in the lumen, which may cause the amplitude of the heartbeat to drop at a relatively slower rate over time.

[0219] In some non-limiting embodiments or aspects, the sensor 254 includes an optical sensor configured to detect movement of the septum 408 of the needleless connector 214. For example, the optical sensor may be connected to the needleless connector including the septum 408 to detect movement of the septum 408. As an example, the smart device 104 may receive a signal related to the movement of the septum from the optical sensor and determine an event related to the needleless connector 214 based on the signal. For example, the event related to the needleless connector may include at least one of a connection event in which the needleless connector 214 is connected to a medical device (e.g., a syringe, a male luer connection, etc.) resulting in movement of the septum 408 (e.g., depression, etc.), a disconnection event in which the needleless connector is disconnected from the medical device resulting in movement of the septum 408 (e.g., release, etc.), or any combination thereof. As an example, the septum 408 may include one or more markings, and the optical sensor may be configured to detect movement of the one or more markings to detect movement of the septum 408.

[0220] In some non-limiting embodiments or aspects, the sensor 254 includes an optical sensor configured to detect at least one of a color signature and a reflection of a medical device connected to and / or coupled to the needleless connector 214, and the smart device 104 may determine the type of medical device based on at least one of the color signature and the reflection of the medical device. For example, the color signature and / or reflection of the medical device may be indicative of a syringe, an IV bag, an infusion pump, and / or a particular type thereof.

[0221] In some non-limiting embodiments or aspects, the sensor 254 includes an acoustic sensor. For example, the acoustic sensor may be connected to the needleless connector 214 and configured to measure one or more sounds, vibrations, etc. (e.g., a sound signature, etc.). As an example, the smart device 104 may receive a signal including the sound signature from the acoustic sensor and determine an event associated with the needleless connector 214 based on the signal.

[0222] In some non-limiting embodiments or aspects, an event associated with the needleless connector 214 includes (i) a connection event in which the needleless connector 214 is connected to a medical device (e.g., a syringe, a cap, etc.) and / or (ii) an operation of a medical device connected to the needleless connector 214. In such examples, the smart device 104 may determine the type of medical device connected to the needleless connector 214 from the multiple types of medical devices and / or the state of the medical device connected to the needleless connector 214 based on a sound signature (e.g., a sound signature generated from connecting the needleless connector 214 to a medical device, a sound signature generated from an operation of the medical device connected to the needleless connector 214, one or more actuation sounds, etc.). For example, the multiple types of medical devices may include two or more of a cap, a syringe, a tube, a medical device connector, or any combination thereof. In some non-limiting embodiments or aspects, the smart device 104 may determine, based on the sound signature, a subtype of the determined type of medical device connected to the needleless connector from multiple subtypes of that type of medical device, such as a syringe subtype (e.g., syringe size, flush syringe, medication syringe, etc.), a cap subtype (e.g., disinfectant cap, etc.), etc. In some non-limiting embodiments or aspects, the state of the medical device includes an unused state or a used state.

[0223] 12 , the medical device includes a syringe 1200. For example, operation of the syringe 1200 may include depressing a plunger 1202 of the syringe 1200 into a barrel 1204 of the syringe 1200, which may generate a sound signature (e.g., one or more actuation sounds, etc.). As an example, the plunger 1202 of the syringe 1200 may include one or more extrusions 1206 that, in combination with the barrel 1204, generate a sound signature (e.g., corresponding to one or more actuation sounds, etc.) when the plunger 1202 of the syringe 1200 is depressed into the barrel 1204 of the syringe 1200. In such an example, the smart device 104 may distinguish the type and / or status of the syringe 1200 based on the sound signature sensed by the acoustic sensor. For example, extrusion 1206 may be positioned or configured to provide an indication of whether the syringe is unused or new (e.g., with plunger 1202 fully extended, such as producing a first sound signature in response to depression of plunger 1202 into barrel 1204), or reused (e.g., with plunger 1202 half-extended, such as producing a second sound signature different from the first sound signature (or sound signature), in response to further depression of plunger 1202 into barrel 1204). In some non-limiting embodiments or aspects, the condition of the medical device includes the volume of fluid expelled from the syringe when plunger 1202 of syringe 1200 is depressed into barrel 1204 of syringe 1200. For example, extrusion 1206 may be positioned or configured to provide a sound signature associated with an indication of the volume applied by syringe 1200 in response to depression of plunger 1202 into barrel 1204 .

[0224] 13A-13C , the medical device includes a disinfectant cap 1300. For example, the disinfectant cap 1300 may include a switch 1302 (e.g., a bi-stable metal dome switch, etc.), and operation of the disinfectant cap 1300 may include connecting the disinfectant cap 1300 to the needleless connector 214. As an example, connecting the disinfectant cap 1300 to the needleless connector 214 may generate a sound signature when the state of the disinfectant cap 1300 includes an unused state, and when the state of the disinfectant cap 1300 includes a used state, connecting the disinfectant cap 1300 to the needleless connector 214 is one of: (i) not generating a sound signature; and (ii) generating another sound signature that is different from the sound signature generated when the state of the disinfectant cap 1300 includes an unused state. In such an example, a bistable metal dome switch incorporated into the disinfectant cap 1300 may create an audio signature (e.g., a tick or click sound) when the disinfectant cap 1300 is attached to the connector, and due to its bistable nature, when the disinfectant cap 1300 is reused, the dome switch may remain in place and not provide an audio signature, thereby enabling detection of the reuse of the disinfectant cap (e.g., if attachment of the cap is detected by the smart device 104 without a tick or click sound, the smart device 104 may determine that the cap is being reused and / or provide an indication of reuse, etc.).

[0225] In some non-limiting embodiments or aspects, sensor 254 includes an identification sensor configured to detect an identification tag on a medical device connected to or coupled to the needleless connector. For example, the identification sensor may include a magnetometer and the identification tag may include magnetic material on and / or integrated with needleless connector 214.

[0226] In some non-limiting embodiments or aspects, the sensor 254 includes a position sensor configured to detect movement of the needleless connector. For example, patient movement, a patient fall event, movement of the patient's bed can be determined (e.g., by the smart device 104, etc.) based on the detected movement of the needleless connector.

[0227] In some non-limiting embodiments or aspects, the sensor 254 includes an RGB color sensor configured to detect the color of the fluid in the fluid flow path of the needleless connector. For example, at least one of blood collection in the needleless connector and blood retention in the needleless connector can be determined based on the color of the fluid detected in the fluid flow path of the needleless connector (e.g., by the smart device 104, etc.).

[0228] 11, in step 1106, the process 1100 includes providing an indication of the event. For example, the smart device 104 may provide an indication of the event. For example, the smart device 104 may provide an indication of the determined event.

[0229] In some non-limiting embodiments or aspects, the smart device 104 including the needleless connector 214 may include a visual indicator 252 that may be configured to provide a visual indication related to at least one of a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is rinsed with a solution, a connection event in which the needleless connector is connected to a medical device, a disconnection event in which the needleless connector is disconnected from a medical device, or any combination thereof. 6B , the smart device 104 may provide direct patient feedback (e.g., via LED illumination to a nurse, etc.) in response to (i) detecting that the needleless connector 214 and / or its lumen 212 have not been cleaned for a predetermined period of time and / or before a scheduled use, (ii) detecting that the needleless connector 214 and / or its lumen 212 have not been cleaned for a sufficient period of time before accessing the catheter line, (iii) detecting that flushing of the needleless connector 214 and / or lumen 212 is scheduled, (iv) detecting that a disinfection cap was not attached after a previous access of the needleless connector 214 and / or lumen 212, etc. For example, the smart device 104 may include the needleless connector 214, which may be configured to detect at least one of a cleaning event, a flushing event, a connecting or capping event, or any combination thereof. As an example, the needleless connector 214 may be configured to provide information and / or data related to a detected cleaning event, a detected flushing event, and / or a detected connecting or capping event (e.g., using the processor 304, memory 306, storage component 308, input component 310, output component 312, etc.) for storing the events and reporting compliance performance for monitoring compliance events.

[0230] In some non-limiting embodiments or aspects, the smart device 104 may include communication circuitry (e.g., communication interface 314, etc.) that wirelessly transmits signals (e.g., force signals, signals other than force signals, etc.) and / or events determined therefrom to a remote computing system. As an example, the smart device 104 may process the signals on a microprocessor within the housing of the smart device 104 that includes the sensor 254 and the microprocessor, and / or the smart device 104 may wirelessly transmit the signals (and / or transmit via a wired connection) to a remote computer that performs digital signal processing on the signals to identify and classify events of interest (e.g., cleaning events, flushing events, connection events, disconnection events, pause or connection times, etc.).

[0231] In some non-limiting embodiments or aspects, a pattern of events including at least one of a cleaning event in which the needleless connector 214 is cleaned with a disinfectant, a flushing event in which the needleless connector 214 is rinsed with a solution, a connecting or capping event in which the needleless connector 214 is connected to a medical device, or any combination thereof can be determined based on the signal (e.g., a force signal, a signal other than a force signal, etc.), and based on the pattern of events, a medication administration event in which a medication is administered to a patient via the needleless connector 214 can be determined.

[0232] In some non-limiting embodiments or aspects, the smart device 104 may detect an identification tag on a medical device connected to or attached to the needleless connector, movement of the needleless connector, the color of fluid in the fluid flow path of the needleless connector, or any combination thereof, and use the visual indicator 252 to provide a visual indication related to any information or data sensed and / or measured by the sensor 254, such as the type of medical device, a medication administration event in which medication is administered to a patient through the needleless connector, the identification of the medical device, a patient movement, a patient fall event, a patient bed movement, the color of fluid in the fluid flow path of the needleless connector 412, blood collection in the needleless connector, blood retention in the needleless connector, a cleaning event in which the needleless connector is cleaned with a disinfectant, a flushing event in which the needleless connector is flushed with a solution, a connecting or capping event in which the needleless connector is connected to a medical device, or any combination thereof.

[0233] While embodiments or aspects have been described in detail for purposes of illustration and description, it should be understood that such details are for that purpose only and are not intended to limit the embodiments or aspects to the disclosed embodiments or aspects, but on the contrary, are intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it should be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect may be combined with one or more features of any other embodiment or aspect. In fact, many of these features may be combined in ways not specifically recited in the claims and / or disclosed herein. Although each dependent claim listed below may depend directly on only one claim, the disclosure of possible implementations includes each dependent claim in combination with any other claims in the claims.

Claims

1. a needleless connector including a fluid flow path; an acoustic sensor connected to the needleless connector; one or more processors, receiving a signal from the acoustic sensor, the signal including sound characteristics indicative of a type, status, and / or operation of a medical device; determining an action associated with the needleless connector based on the signal, the action including at least one of (i) a connection action in which the needleless connector is connected to the medical device, or (ii) an action in which the medical device is connected to the needleless connector; and one or more processors programmed and / or configured to: A system comprising:

2. 2. The system of claim 1, wherein the operation associated with the needleless connector includes a connecting operation in which the needleless connector is connected to the medical device, and the one or more processors are further programmed and / or configured to determine the type of medical device connected to the needleless connector from a plurality of types of medical devices based on the sound characteristics.

3. The system of claim 2 , wherein the multiple types of medical devices include two or more of a cap, a syringe, a tube, a medical device connector, or any combination thereof.

4. The system of claim 3 , wherein the one or more processors are further programmed and / or configured to determine a subtype of the determined type of the medical device connected to the needleless connector from a plurality of subtypes of medical devices of that type based on the sound characteristics.

5. The system of claim 1 , wherein the operation associated with the needleless connector includes the operation of the medical device connected to the needleless connector, and the one or more processors are further programmed and / or configured to determine a status of the medical device connected to the needleless connector based on the sound characteristics.

6. The system of claim 5 , wherein the state of the medical device comprises an unused state or a used state.

7. 6. The system of claim 5, wherein the medical device includes a syringe, and the actuation of the syringe includes depressing a plunger of the syringe into a barrel of the syringe, and the depressing of the plunger of the syringe into the barrel of the syringe produces the sound characteristic.

8. 8. The system of claim 7, wherein the plunger of the syringe includes one or more extrusions that combine with the barrel of the syringe to produce the sound signature when the plunger of the syringe is depressed into the barrel of the syringe.

9. The system of claim 8 , wherein the state of the medical device comprises a volume of fluid expelled from the syringe when the plunger of the syringe is depressed into the barrel of the syringe.

10. The system of claim 6 , wherein the medical device includes a disinfectant cap.

11. 11. The system of claim 10, wherein the antiseptic cap includes a switch, and the operation of the antiseptic cap includes connecting the antiseptic cap to the needleless connector, and the connecting of the antiseptic cap to the needleless connector produces the sound characteristic when the state of the antiseptic cap includes the unused state.

12. 12. The system of claim 11, wherein when the state of the sanitizer cap includes the used state, the connection of the sanitizer cap to the needleless connector results in at least one of: (i) not producing the sound characteristic; and (ii) producing another sound characteristic that is different from the sound characteristic produced when the state of the sanitizer cap includes the unused state.

13. The system of claim 11 , wherein the switch comprises a bi-stable metal dome switch.

14. The system of claim 1 , further comprising an identification sensor configured to detect an identification tag connected to the needleless connector or on the medical device connected to the needleless connector.

15. The system of claim 14 , wherein the identification sensor comprises a magnetometer and the identification tag comprises a magnetic material.

16. 10. The system of claim 1, further comprising a position sensor configured to detect movement of the needleless connector, wherein the one or more processors are further programmed and / or configured to determine at least one of patient movement and movement of the patient's bed based on the detected movement of the needleless connector.

17. The system of claim 1, further comprising a color sensor configured to detect the color of the fluid in the fluid flow path of the needleless connector, wherein the one or more processors are further programmed and / or configured to determine whether the fluid in the fluid flow path is at least one of blood drawn in the needleless connector and blood stagnating in the needleless connector based on the color of the fluid detected in the fluid flow path of the needleless connector.

18. At least one non-transitory computer-readable medium containing program instructions, which when executed by at least one processor, cause the at least one processor to: acquiring a signal provided by an acoustic sensor connected to a needleless connector including a fluid flow path; determining, based on the signal, at least one of a connect operation in which the needleless connector is connected to a medical device, a disconnect operation in which the needleless connector is disconnected from the medical device, or any combination thereof; and providing an indication of the determined action.

19. 20. The at least one non-transitory computer-readable medium of claim 18, wherein the at least one non-transitory computer-readable medium includes program instructions that, when executed by the at least one processor, cause the at least one processor to determine, based on the signal, the type of medical device connected to the needleless connector from a plurality of types of medical devices.

20. detecting an acoustic signal with an acoustic sensor connected to a needleless connector including a fluid flow path; receiving, with at least one processor, information regarding the detected acoustic signal from the acoustic sensor; determining, with at least one processor, based on the information regarding the detected acoustic signal, at least one of a connect operation in which the needleless connector is connected to a medical device, a disconnect operation in which the needleless connector is disconnected from the medical device, or any combination thereof; A method for providing the above.

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