Peripheral venous catheter assembly using sensors and related methods

Abstract

The present invention relates to a catheter (104) equipped with a monitoring function that can upload sensed or acquired data to a smart device (120) and / or a cloud server (130). [Solution] A catheter system 100 comprising: a catheter hub 110 including a hub body having an external and internal structure; a catheter tube having a lumen attached to the catheter hub 110; a sensor 106 attached to at least one of the hub body and the catheter tube for sensing the status of the catheter hub 110 or monitoring the patient's condition; and at least one smart device 120 and a cloud server 130 for collecting data sensed by the sensor 106.

Description

Technical Field

[0001] The present invention generally relates to catheter assemblies, and more particularly to catheter assemblies such as over-the-needle catheter devices having sensors for monitoring the condition of a human and / or the condition of a catheter, and related methods. Safety features such as needle guards or needle shields, and flow control features such as septums, valves, and valve actuators for operating the valves can be incorporated into catheter assemblies such as peripheral IVCs, central venous catheters, peripherally inserted central catheters, and median catheters.

Background Art

[0002] When using catheters such as venous catheters, central venous catheters, peripherally inserted central catheters, and median catheters, it is often necessary for medical personnel to carefully monitor the environmental conditions of the patient and the catheter itself. However, in medical procedures, medical personnel often need to perform multiple tasks, increasing the likelihood of errors. When a catheter assembly is connected to a patient and / or a fluid source (such as an intravenous infusion source), the only visual indication for a physician of the situation of the infused fluid, the state of the catheter device, the position of the catheter hub, etc. usually results from visiting the patient and observing the puncture site and its surroundings.

Summary of the Invention

[0003] Various embodiments of the present catheter system have several features, none of which alone is solely responsible for their desirable attributes. Without limiting the scope of the present embodiments as described in the following claims, their more prominent features are briefly discussed here.

[0004] Aspects of the present disclosure preferably include an intravenous catheter system comprising a catheter hub including a hub body having an external and internal part, a catheter tube attached to the catheter hub, a sensor attached to the hub body for sensing the status of the catheter hub or for monitoring the patient's condition, and at least one of a smart device and a cloud server for collecting data sensed from the sensor.

[0005] Smart devices are preferably suited for wireless communication with sensors in intravenous catheter systems. Smart devices can be electronic devices that are generally connected to other devices or networks via various wireless protocols such as Bluetooth, NFC, Wi-Fi, and 3G, and can operate to some extent bidirectionally and autonomously. Smart devices may include smartphones, phablets and tablets, smartwatches, smart bands, and smart keychains.

[0006] The sensor can be attached to any part of the catheter to monitor its condition. The sensor may be, for example, a first sensor attached inside the hub body.

[0007] The second sensor may be included in the catheter system, or it may be external or coupled to the hub body.

[0008] A second sensor can be coupled to a wing extending from the hub body. Additional or alternative sensors can be incorporated into the catheter tube, such as by forming part of the OD, ID, or the inside of the catheter tube.

[0009] Using one or more sensors, any suitable metric (measurement), such as blood flow, pulse rate, blood pressure, blood oxygen level, body temperature, local skin temperature, pH value, catheter occlusion, and flow rate, can be measured and monitored.

[0010] A suitable wireless transceiver, such as a BLE (Bluetooth Low Energy) module, can be electrically coupled to a sensor, allowing the sensed data to be relayed to a smart device using a wireless connection.

[0011] Wireless transceivers can include, for example, BLE transceivers, Wi-Fi transceivers, infrared transceivers, and RF (radio frequency) transceivers. Such transceivers can either transmit and receive data, or they can be transmitters that only transmit data. BLE modules can be electrically coupled to sensors, and gateways can include BLE modules and Wi-Fi modules. In alternative embodiments, dedicated transmitters and receivers can be used instead of transceivers.

[0012] The detected data can be collected by a cloud server via the gateway's Wi-Fi module.

[0013] The system may include a heat-to-electric converter to power one or more sensors using ambient heat, such as heat from a patient.

[0014] The system may include a flexible supercapacitor to convert heat into electricity to power one or more sensors.

[0015] The hub body of a catheter hub may include a first hub body portion attached to a second hub body portion. The two portions allow access to the inside of the hub body before joining them together, which helps in mounting or installing any number of components, such as sensors.

[0016] The sensor may include multiple individual sensors distributed along the length of the catheter tube.

[0017] Preferably, the intravenous catheter system may further include an optical fiber sensor to which the sensor is connected and which is connected to an electronic connector assembly that is detachably connected to the catheter hub.

[0018] The sensor attached to the catheter tube may be an optical fiber sensor extending to an electronic connector assembly that is detachably connected to the catheter hub.

[0019] A method for monitoring signals collected by a catheter assembly is disclosed. This method may include the steps of: providing a sensor comprising a catheter hub having a hub body comprising an external and internal hub body; wirelessly relaying data collected by the sensor to at least one of a smart device and a cloud server; and displaying information related to the collected data in a report.

[0020] Aspects of the present invention include a method for manufacturing a catheter assembly equipped with one or more sensors.

[0021] A further aspect of the present invention is a method for manufacturing the peripheral intravenous catheter system described herein. Similar manufacturing concepts can be used for the manufacture of central venous catheters, peripherally inserted central catheters, and median catheters.

[0022] Aspects of the present invention preferably further include an intravenous catheter system comprising a catheter hub including an external and internal hub body, a catheter tube having a lumen attached to the catheter hub, a sensor attached to at least one of the hub body and the catheter tube for sensing the status of the catheter hub or monitoring the patient's condition, and at least one of a smart device and a cloud server for collecting data sensed by the sensor.

[0023] The sensor can be designated as the first sensor and can be mounted inside the hub body.

[0024] Preferably, the intravenous catheter system may include a second sensor, which can be mounted outside the hub body.

[0025] The second sensor can be attached to a wing extending from the hub body.

[0026] The second sensor can be attached to a catheter tube.

[0027] Preferably, the intravenous catheter system can further include a BLE module electrically coupled to the sensor for relaying sensed data to a smart device using a BLE connection.

[0028] Preferably, the intravenous catheter system can include a BLE module electrically coupled to the sensor and a gateway including the BLE module and a Wi-Fi module.

[0029] The sensed data can be collected by a cloud server via the Wi-Fi module of the gateway.

[0030] The hub body of the catheter hub can include a first hub body portion attached to a second hub body portion.

[0031] A needle guard for covering the tip of the needle can be included inside the hub body. The needle guard can include a proximal wall with an opening and at least one elastic spring such as a spring arm.

[0032] The hub body can include a side port and an open proximal end. A tube can be connected to the side port, and a fluid adapter such as a needleless valve can be connected to the end of the tube away from the side port. Alternatively, the hub body can include a single formed port, also known as a ported catheter.

[0033] The sleeve can be disposed on the hub body with a side port.

[0034] A valve and a valve opener can be disposed inside the hub body.

[0035] The sensor attached to the catheter tube can be lined inside the catheter tube or embedded in the wall of the catheter tube.

[0036] Further aspects of the present disclosure preferably include a catheter hub comprising a hub body having an external and internal structure, a catheter tube having a lumen attached to the catheter hub, a sensor attached to at least one of the hub body and the catheter tube for sensing the condition of the catheter hub or for monitoring the condition of a patient, and an electrical connector assembly comprising electronic equipment for processing data sensed by the sensor, the electrical connector assembly comprising a connector housing attached to the hub body.

[0037] The electrical connector assembly may include an analog-to-digital converter, and the connector housing can be mounted on the proximal end of the hub body.

[0038] The electrical connector assembly may include an analog-to-digital converter, and the connector housing can be mounted to the side port of the hub body.

[0039] The electrical connector assembly may include a processor and a power supply.

[0040] The connector housing of the electrical connector assembly can be attached to and detached from the hub body.

[0041] Another aspect of the present disclosure preferably includes a catheter hub comprising a hub body having an external and internal structure, a catheter tube having a lumen attached to the catheter hub, and a sensor attached to at least one of the hub body and the catheter tube for sensing the status of the catheter hub or for monitoring the patient's condition.

[0042] Preferably, the intravenous catheter system may include at least one of a smart device and a cloud server for collecting sensed data.

[0043] A further aspect of the present disclosure is a method for monitoring signals collected in a catheter assembly, comprising the steps of: providing a sensor comprising a catheter hub having a hub body having an external and internal; wirelessly relaying data collected by the sensor to at least one of a smart device and a cloud server; and displaying information relating to the collected data in a report.

[0044] The catheter assembly's sensor can electrically communicate with lead wires in a computing core, which may be located outside the housing. The computing core may be part of an electrical connector assembly that can screw onto the proximal end of the catheter hub. The catheter assembly may have a piston located within the housing of the electrical connector assembly. The catheter assembly's flow path may be formed at least partially between the outer surface of the piston and the inner surface of the housing.

[0045] In some examples, fiber optic sensors can be used as sensing elements, also known as intrinsic sensors, or as means for relaying signals from remote sensors to electronic devices that process signals, also known as extrinsic sensors. Fiber optic sensors can be used to measure strain, temperature, pressure, or other quantities. Thus, aspects of this disclosure are understood to include the use of fiber optic sensors for the purposes of intrinsic sensors, extrinsic sensors, or both.

[0046] A system for performing therapeutic infusion therapy with monitoring functions according to the embodiments of this disclosure is disclosed. In one example, the system can monitor and record the patient's condition and / or the condition of the catheter assembly used to perform the treatment while the patient is receiving therapeutic infusion therapy.

[0047] By recording and monitoring various conditions and statuses of the patient and / or catheter, important clinical information can be provided to clinicians, enabling them to modify or continue the treatment course for optimal patient care. In some cases, various conditions can be tracked and recorded in real time to enable up-to-date feedback on the progress of the patient's treatment. In exemplary embodiments, the catheter device may be a central venous catheter, an intravenous catheter, a peripherally inserted central catheter ("PICC"), or a catheter other than a peripheral venous catheter such as a median catheter. According to embodiments of this system, a catheter assembly equipped with sensors includes one or more sensors for monitoring the patient's condition and / or the status of the catheter.

[0048] As used herein, “sensor” includes devices that convert sensed data into measurable electronic signals, such as a piezometer that converts sensed pressure data into a metric for measuring pressure, or a thermometer probe that converts measured current into a metric for measuring temperature. Sensors “mounted” to elements such as inside or outside a catheter hub or needle hub have an exposed input surface that shares the environment with the element. Sensors “embedded” within elements such as the wall of a needle or catheter tube have an input surface that may not be exposed (e.g., a temperature sensor that senses ambient temperature through the wall) or an input surface that may be exposed (e.g., a pH sensor that has an input surface that is in fluid communication with the inner or outer surface of the catheter tube).

[0049] For example, the assembly may have at least one sensor to sense and / or monitor the patient's condition, such as body temperature, or to sense and / or monitor the internal or external environment of the catheter hub, such as flow or pressure. One or more sensors may include, to give some non-limiting examples, accelerometers for detecting motion, pressure sensors, temperature sensors, position and humidity sensors, and may be used to measure and monitor blood flow, pulse, blood pressure, blood oxygen level, body temperature, local skin temperature, pH value, catheter occlusion, flow rate, etc.

[0050] Depending on the size of a typical catheter assembly, the sensor may be appropriately sized and shaped accordingly and may be powered using body heat. For example, a heat-to-electric converter can be used to charge a capacitor, which in turn can power the sensor for use in the device of this disclosure. Alternatively or additionally, a flexible supercapacitor may be used to power the sensor. Flexible supercapacitors capable of storing charge using heat from the surroundings have been discovered and are described in U.S. Patent Application Publication 2014 / 0338715 and U.S. Patent Application Publication 2010 / 0051079.

[0051] The power emitted from a flexible supercapacitor can be configured to power one or more sensors and associated modules, such as a communication module for forwarding detected signals to a server, controller, or other module for further processing. In some embodiments, a flexible supercapacitor can be used to charge a battery or capacitor, which is then used to power one or more electronic devices, such as a sensor or processor.

[0052] Flexible supercapacitors are known to researchers and scientists and have been experimented with in connection with wearable electronic devices. These thermochargeable solid supercapacitors can be made from a solid polymer electrolyte that generates a large thermal induction voltage from a heat source such as body temperature. The voltage can then initiate an electrochemical reaction in the electrolyte for charging. The capacitor can also use conventional charging methods for capacitors. The sensor can be integrated into a wireless data transmission system to send data to a local electronic device used by an app, or to a cloud server via a Wi-Fi gateway, which can then be viewed, recorded, trend analyzed, and analyzed using a web browser dashboard. In a preferred embodiment, the flexible supercapacitor is coupled to an element of a catheter directly connected to the patient, such as the wings of a catheter hub, or to a part of a catheter tube.

[0053] A catheter assembly equipped with the sensor of the present invention can embody catheter devices as shown in U.S. Patent No. 8,382,721, No. 8,540,728, and No. 8,597,249, the contents of which are expressly incorporated herein by reference. The catheter assembly may include one or more sensors arranged with a catheter hub, a needle hub, or both. Depending on the state to be sensed and the type of data to be acquired, the sensors may be located inside the catheter hub and needle hub, and / or outside the catheter hub and needle hub.

[0054] In some cases, the needle guard can be provided with the catheter assembly and positioned outside the catheter hub, such as within a third housing located between the catheter hub and the needle hub. In other cases, the needle can be covered after successful venipuncture using a spring-loaded needle hub with a pushable tab that pushes the needle into a protective barrel or sheath.

[0055] One or more sensors can be integrated with a Bluetooth Low Energy (BLE) module that communicates with a local smart device having a Bluetooth connection, allowing data sensed or acquired by the sensors to be communicated to the local smart device. The local smart device may include a server, laptop computer, desktop computer, handheld device such as a smartphone or tablet, or a combination thereof.

[0056] Custom program software can be provided to a local smart device to process and display the sensed data, allowing for manipulation of the data for viewing and reporting any number of times, such as identifying trends or tracking high or low setpoints. Because the range of Bluetooth communication is limited, the local smart device is usually placed within 15-20 meters of the catheter assembly to ensure a strong wireless connection between the catheter assembly and the smart device.

[0057] Alternatively or additionally, the catheter assembly can communicate with a cloud server via a gateway that can be dedicated to the catheter system. In one example, the gateway may incorporate both a BLE module and a Wi-Fi module. Communication between the catheter assembly and the gateway can be done via a BLE connection, and communication between the gateway and the cloud server can be done via Wi-Fi, for example, by communicating with a router using Wi-Fi and then communicating with the cloud.

[0058] Therefore, data sensed, collected, or acquired by one or more sensors on the catheter assembly can be transmitted to a cloud server via the gateway for recording, monitoring, analysis, and / or viewing. In some examples, a BLE mesh network can be provided to extend the range between the catheter assembly and the gateway. In one example, data analysis and a web browser dashboard are provided to the cloud server, which analyzes the uploaded data for usable information, such as identifying trends, patterns, and causal relationships of various detected states. Reports of the uploaded and collected information can be generated, such as being provided in bar graph format, line graph format, or text / written report format, or a combination thereof.

[0059] Individuals authorized by clinicians or patients can access data stored on cloud servers from anywhere with an internet connection, using web browser dashboards and smart devices, as stipulated by health and hospital policies. Appropriate security and authentication may be required before clinicians and authorized users can access stored data.

[0060] In one example, the catheter hub has a needle hub coupled to the catheter hub and a pair of wings having needles. The catheter hub has a catheter tube attached to the distal end of the hub body and a proximal inlet or opening at the opposite end having a Luer taper for receiving a male Luer tip such as a male infusion line, syringe, or male Luer adapter. One or more sensors can be incorporated with the catheter assembly of this embodiment in the catheter tube, the hub body of the catheter hub, the wings, or a combination thereof. One or more sensors can be positioned inside the hub body, inside the catheter tube, outside the hub body, outside the wings, embedded in the wall of the hub body, or a combination thereof.

[0061] The catheter hub can be positioned to fluidly communicate with the peripheral veins of the patient's hand at the puncture site. In some cases, the puncture site may be in the forearm or another location, rather than connecting to the peripheral veins of the hand, for example, near the chest for central venous catheters, or in the upper arm region for PICC or median catheters.

[0062] The catheter hub can be secured to the hand using a medical bandage that can be fixed to the hand with adhesive. Alternatively or additionally, the medical bandage can be incorporated into the wing without using adhesive, tape, or bandage separately to secure the catheter hub to the hand. One or more sensors of this disclosure can be mounted externally to the catheter hub, such as when an accelerometer is mounted to the wing to detect movement of the catheter hub or hand. In other examples, sensors can be mounted inside the catheter hub, on the wall of the catheter hub, or in the lumen of the catheter tube to detect patient conditions such as pH, oxygen levels, or local temperature.

[0063] In some cases, the electronic components of this system can be located both inside and outside the catheter hub and catheter tube. For example, both the wireless module and the power module can be located outside the catheter hub to supply power to various sensors and modules, or to transmit collected signals to a local smart device or cloud server. Thus, sensors mounted inside the hub body are in fluid communication with fluids passing through the catheter hub, including intravenous fluids and blood, while other modules, such as non-sensor modules, can be located outside and are not exposed to any wet or liquid environments.

[0064] One or more sensors can be coupled to the catheter hub to sense, detect, and / or monitor various patient conditions such as body temperature or local temperature, blood temperature, blood pH level, and / or the status of the catheter hub, such as whether the hub body has moved (e.g., by triggering an alert when an accelerometer detects directional movement), or whether flow has been detected through the catheter hub (e.g., by measuring flow rate or pressure). Thus, this catheter assembly, such as the catheter hub of this catheter assembly, can not only be configured to function as a medium for fluid infusion therapy, but can also include one or more sensors to provide data on several different conditions that clinicians can use to evaluate the effectiveness of the infusion therapy and various other aspects.

[0065] In an exemplary embodiment, the catheter hub has a hub body having a first hub portion attached to a second hub portion. The two hub body portions provide convenient access to the interior of the hub body, facilitating the installation of one or more sensors and, optionally, other components such as valves and valve openers into the hub body. After installing one or more sensors and, where applicable, valves, valve openers, and needle guards, the two hub body portions can be joined and secured to each other by adhesive, bonding, welding, or a combination thereof.

[0066] The catheter tube can be attached to the distal end of the first hub portion using conventional means such as a metal bushing. In some examples, the catheter hub may be an integrated infusion catheter having a lateral fluid port extending from the hub body and a tube attached to the fluid port, and a fluid adapter such as a needleless connector attached to the opposite end of the tube. Baffles may be located inside the hub body of the integrated infusion catheter, proximal to the fluid port, and distal to the proximal catheter hub opening. In alternative embodiments, the catheter hub may include a single-formed port, also called a ported catheter, for directly receiving a male Luer tip without a flexible tube.

[0067] A needle hub, comprising a needle having a needle tip and a change-in-profile portion which may be a crimp, bulge, sleeve, or material buildup, can be removed from the catheter hub after successful venipuncture. The needle hub may have a needle hub body that forms an internal flashback chamber with a proximal opening, usually fitted with a vent plug (not shown), to prevent blood flashback from leaking out of the proximal opening. One or more sensors may be placed inside the needle hub body or elsewhere along with the needle hub to sense blood conditions such as oxygen or pH levels.

[0068] A needle guard or tip protector can be moved to the distal end of the needle to surround or block the needle tip. Embodiments of needle guards are disclosed in U.S. Patents 8,382,721, 8,540,728, and 8,597,249, and are incorporated by reference. In some examples, other needle safety devices or guards to prevent accidental needle sticks can be used with catheter assemblies equipped with one or more sensors. For example, a spring-loaded needle assembly can be activated to push a shield to cover the needle in a protected position after use, or to push the needle into a fixed outer protective barrel used to cover the tip of a used needle.

[0069] The catheter tube comprises a body with a distal opening and an enlarged proximal portion having a proximal opening for receiving a metal bushing for securing the proximal portion inside the catheter hub. In one example, the interior of the tube body may be partially or completely lined with polypyrrole sensing material. For example, the annular space of the catheter tube body may be lined with polypyrrole sensing material for use in detecting one or more of the following: temperature, blood flow, blood pressure, blood oxygen level, pH value, catheter occlusion, etc. In one example, the inner layer of the sensing material may form a complete circumference inside the outer catheter body material, extending the length of the catheter tube or a portion of the length of the catheter tube.

[0070] The body of a catheter tube or catheter hub may have one or more sensors impregnated or embedded in its wall layer. The proximal portion of the catheter tube may be made of a conductive metallic material for connecting to other electronic modules such as a power supply and a wireless signal transmitter that acquire signals from the sensing material and convert them into electricity using heat. In some examples, the proximal portion may be made of a conductive polymer material, also known as an intrinsically conductive polymer (ICP). ICPs are organic polymers known to conduct electricity.

[0071] In one example, a catheter system according to an aspect of the present invention includes a sensing module, a data processing module, and a communication module, which can be arranged on the catheter assembly or across several platforms, such as the catheter assembly and nearby peripheral equipment. A power supply module that uses thermal-to-electrical conversion can be incorporated to supply energy to various sensors.

[0072] The sensing module may comprise one or more individual sensors for detecting any of the various parameters and conditions described elsewhere in this specification. Individual sensors may be located inside the catheter body, in the lumen of the catheter tube, and / or inside the needle hub. Individual sensors may also be mounted externally to the catheter hub body, such as on the wings of the catheter hub, the hub body, and / or the medical bandage. For example, an accelerometer may be mounted on the wings of the catheter hub to detect motion, and a temperature sensor may be used to detect the patient's surface skin temperature or local temperature.

[0073] The sensing modules provided herein may include an analog-to-digital converter (A / D converter) for converting analog signals to digital signals. Optionally, the analog signals may be transmitted directly to a smart device or cloud server via a communication module for processing, conversion, and manipulation remotely, away from the catheter assembly. For example, the analog-to-digital conversion can be performed on the cloud server. This enables the systems of this disclosure to operate with low power requirements and, if the analog-to-digital conversion can be processed elsewhere, may allow for low-cost implementation.

[0074] This system may include a data processing module having a controller that may include a microcontroller and / or microprocessor, which may be embodied on a printed circuit board (PCB). The data processing module may be provided with firmware and software that processes digital signals from an A / D converter and performs one or more functions related to the processed signals, such as transmitting signals to a smart device or transmitting signals to a cloud server via a gateway.

[0075] Optionally, data processing can be performed by a smart device or by data analysis on a cloud server. In a preferred embodiment, the data processing module simply functions as a data queue that transmits sensor data to a transmitter, preferably a wireless transmitter such as wireless communication. The data processing module preferably has temporary or non-temporary memory that stores data received from one or more sensors and transmits them to a remote computer system capable of processing the data, such as a cloud server or a local smart device. In a preferred embodiment, the data processing module adds a unique label to each data segment that uniquely identifies sensors, such as a temperature sensor in a catheter tube and a temperature sensor in a catheter hub, so that the receiving computer system can classify the sensor data accordingly. Such labels can be added using appropriate means, such as XML (Extensible Metalanguage) format. For example, each packet transmitted from the transceiver may include a timestamp, a set of sensor metrics, the type of each sensor, and a unique identifier for each sensor. The unique identifier may be a location or position within the catheter, so that the data processing system can calculate the distance between at least two sensors.

[0076] The remote computer system can process sensor data, compile data reports, or perform appropriate analysis on the data, such as triggering alerts when data threshold metrics are exceeded, such as blood temperature exceeding or falling below a threshold, or blood flow exceeding or falling below a threshold. In some embodiments, the data processing module can be configured to perform such analysis, such as triggering an LED light on a catheter when a predetermined threshold is reached. In preferred embodiments, data from multiple sensors can be analyzed to create metrics, for example, using data metrics from a first temperature sensor at a first location and a second temperature sensor at a second location to calculate the temperature difference between blood measured from the first location to the second location.

[0077] This system may include a data communication module for transmitting sensed signals to a smart device or cloud server using any suitable wireless transceiver, such as a BLE-connected device or Wi-Fi. Data analysis can be used to display the signals on a PC, laptop, or mobile device via charts, tables, and / or reports.

[0078] Sensors described elsewhere in this specification may be made from materials that may include polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoethyl (PAN). One or more sensors, together with or incorporated into the catheter assembly of this embodiment, can be connected physically or wirelessly to a wireless data transmission component such as a BLE module, and the collected data is transferred to a smart device or cloud server for use in data analysis, apps, or web browser dashboards, in order to analyze the uploaded data with respect to usable information, such as trends, patterns, and causal relationships of various detected states.

[0079] In some examples, fiber optic sensors can be used as sensing elements, also known as intrinsic sensors, or as means for relaying signals from remote sensors to electronic devices that process signals, also known as extrinsic sensors. Fiber optic sensors can be used to measure strain, temperature, pressure, and other quantities. Thus, aspects of this disclosure are understood to include the use of fiber optic sensors for both intrinsic sensor purposes, extrinsic sensor purposes, or both purposes.

[0080] With respect to catheter assemblies comprising sensors and assembly components disclosed herein, if features are shown but not explicitly described, and otherwise are the same or similar to one or more features described elsewhere, then any disclosed portion shown in all drawings but not explicitly described for the sake of redundancy or because the knowledge is built upon a foundation established by prior disclosures is understood to still be described or taught by the same or similar features as those explicitly described in the text of the embodiments in which one or more features are described. In other words, subsequent disclosures of this application are built upon the foundations of prior disclosures unless the context indicates otherwise.

[0081] Therefore, it is understood that this disclosure teaches the disclosed embodiments and features of the disclosed embodiments to those skilled in the art without the need to repeat similar parts and features in all embodiments, since skilled in the art will not disregard similar structural features that they have just read about in some preceding paragraphs, nor will they ignore the knowledge gained from previous descriptions in the same specification. Accordingly, the same or similar features shown in the following catheter assemblies incorporate teachings from previous embodiments unless the context indicates otherwise. Accordingly, unless the context indicates otherwise, later disclosed embodiments are intended to enjoy the advantages of earlier explicitly described embodiments, such as the features and structures of the earlier described embodiments.

[0082] In one example, the needle used within the catheter tube may instead be a stylet or a solid needle shaft. In some examples, a guidewire is used with the catheter assembly to help guide the placement of the catheter tube. The catheter hub has a catheter hub body and a catheter tube having a tube body attached to the hub body with a metal bushing or the like. In one example, the inside of the tube body may be partially or completely lined with a sensing material such as polypyrrole sensing material. For example, the annular space of the catheter tube body may be lined with polypyrrole sensing material for use in detecting one or more of the following: temperature, blood flow, blood pressure, blood oxygen level, pH value, catheter occlusion, etc. In some examples, the sensor may be embedded inside the thickness of the catheter tube.

[0083] The catheter tube has a body with a distal opening and a proximal portion made of a conductive material. In some embodiments, the body may include one or more sensors embedded in insulating material that are electronically coupled to the conductive proximal portion via an insulating path, so that the conductive proximal portion can contact an input port of an electronic device, such as an input to an A / D converter or data processing module. Alternatively, the proximal portion may be made of a polymer material and lined with a sensing or conductive material, as will be discussed further below. The distal opening may have a reduced opening compared to the rest of the catheter tube to form a seal around the needle shaft or stylet. The proximal portion of the catheter tube may be made of a conductive material for connecting to other electronic modules, such as a power supply and a radio signal transmitter, which receive signals from the sensing material lining the inside of the tube body and convert them into power using heat. Alternatively, the sensing material may extend beyond the proximal portion, and an electrical connector is used to couple the sensor to the other device.

[0084] In some cases, the proximal portion can be made from a conductive polymer material, also known as an intrinsically conductive polymer (ICP). ICPs are organic polymers known to conduct electricity. The sensor material can be made from a material that may include polypyrrole, carbon nanotubes, glassy carbon, and polyacryloinoityl (PAN). In some cases, the sensing material of the tube body and the sensing material of the proximal portion of the catheter tube may be formed integrally or as a single unit.

[0085] In one example, electrical communication between a sensor placed in a catheter tube and a conductor placed in a catheter hub can be provided via or by using an electrical connector. In one example, the electrical connector is made from a conductive polymer material such as ICP, polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoyl (PAN). In another example, the electrical connector is made from a conductive metallic material such as copper, brass, or an alloy thereof. Alternatively, one or more optical fibers can be used for the sensor and / or conductor, as described above.

[0086] The connector may have a body portion and a flange portion, with a gap between them. The body portion may contact or wedge with the sensor together with the catheter hub. A portion of the sensor with the catheter tube can be positioned in the gap. When a metal bushing is pressed into the catheter hub and the catheter tube is wedge between the catheter hub and the metal bushing, the flange can be clamped to the proximal end of the catheter tube sensor on the catheter hub and to the body portion of the electrical connector.

[0087] In one example, the catheter tube sensor has a proximal end that is longer than the proximal end of the catheter tube body, and as a result, the folded portion of the catheter tube sensor folds around the outside of the catheter tube body and makes direct contact with the main body of the connector. This folded portion allows the catheter tube sensor to make direct contact with the main body of the connector, as well as through contact with the flange.

[0088] The electronic connector assembly can be attached to the proximal end of the catheter hub body. The electronic connector assembly may include a connector housing and an electrical module. The connector housing can be attached to the proximal end of the catheter hub for mounting an electronic module for use with a sensor and conductor.

[0089] In some examples, the optical fiber sensor can be attached to the catheter tube and coupled to the connector assembly. The connector housing can be made of a thermoplastic material and may have a male tip for insertion into the proximal opening of the catheter hub and a threaded collar for screw-in engagement with the male thread in the catheter hub. In other examples, the connector housing can be fixed to the catheter 110 using various fastening means such as adhesive, locking, bonding, welding, or a combination thereof. The connector housing can be elongated and may have a Luer taper for receiving the male Luer tip and may include a male thread for screw-in Luer connection.

[0090] The conductors can also extend outside the connector body, presenting a surface for contact with the conductor attached to the catheter hub. The male tip of the connector can be sized and shaped to wedge the two conductors tightly into contact and seal their interface from fluid flow. The contact between the conductors at the interface between the catheter hub and the electronic connector assembly enables electrical communication between the electrical module and the sensor on the catheter tube.

[0091] In one example, as described elsewhere in this specification, the electronic module may include a sensing interface, a communication interface, and a power supply. A cover may be provided around the electronic module to seal it from damage or unwanted exposure. In one example, the cover may be a silicone material or a coat or layer of a sleeve.

[0092] In one example, the conductor contacts the sensor directly or indirectly within the catheter tube. The conductor can be used as an extension or connector for coupling the sensor within the catheter tube to an electrical connector assembly, which includes a connector or connector housing, an electrical module, and a cover. In an exemplary embodiment, the conductor has a receiving end that may be either a receptacle or a plug. The other receptacle or plug can be attached to the tip of the connector. The receptacle connects to the plug to provide an electrical path between the conductor and the electrical module. Alternatively, an optical fiber sensor can be incorporated into the catheter tube, and the sensor is connected to the electrical connector assembly using an optical fiber. In one example, the electrical assembly is detachable from the catheter hub to disconnect the receptacle and plug. The detachable configuration allows the electrical connector assembly to be removed from the catheter hub and reused or used in another catheter assembly or for another purpose.

[0093] In one example, the connector housing of the electrical assembly is removable from the proximal end of the catheter hub. Removal is possible by providing a connection between the sensor of the catheter tube and the conductor of the electrical assembly using the conductor of the catheter hub. The connector can be removablely secured to the catheter hub by screwing it in via a threaded collar of the connector that engages with the threads of the catheter hub using press-fit or contact mating.

[0094] In exemplary embodiments, the hub body includes a side port having a channel (groove) or flow path that communicates fluid with the internal cavity of the catheter hub. Although not shown, a sleeve-shaped valve can be placed inside the catheter hub to block the fluid path at the intersection of the channel and the internal cavity. The sleeve prevents fluid from the internal cavity from leaking through the side port. However, the fluid pressure flowing through the side port from a syringe or drip line, for example, may cause at least a portion of the sleeve to fold, resulting in fluid flowing into the channel, into the internal cavity, and out through the catheter tube. The valve and valve opener may be located in the proximal portion of the internal cavity, as previously discussed in other catheter embodiments. In some examples, the sleeve and valve may be a single or separate structure. The valve may be located proximal to the folding sleeve.

[0095] Sensors can be placed inside the catheter tube for connection to an electrical connector assembly via conductors located in the catheter hub body and side ports. In one example, the sensor may be formed separately inside the catheter tube and then connected to the electrical connector assembly using a conductor. In some examples, optical fibers can be used as external sensors to relay signals. Alternatively, the connector can be formed continuously using conductive polymer materials, polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoyl (PAN).

[0096] An electrical connector assembly may include a connector housing, an electrical module, and a cover attached to the side port. In one example, the electrical connector assembly is removable from the side port and, if removed, can be refurbished or reused in another catheter hub. Removal is made possible by providing a connection between the sensor and the conductors of the electrical assembly, which is press-fit or contact-mating and is detachably secured by a connector that engages with the side port of the catheter hub, such as by screwing in a threaded collar of the connector that has threads on the catheter hub.

[0097] The electronic components of an electrical connector assembly may include an A / D converter for converting signals from one or more sensors attached to a catheter hub and / or catheter tube, as described above. The A / D converter can be powered from a power source that can be powered using body heat. For example, a heat-to-electric converter can be used to charge a capacitor and power various components. A thermally charged solid supercapacitor can be made from a solid polymer electrolyte that can generate a large thermal induction voltage from a heat source such as body heat to power electronic components. In some examples, the heat-to-electric converter can first charge a battery, which then powers the electronic components.

[0098] The electrical connector assembly may further include a processor or CPU for storing and processing firmware and software, and memory. A pulse-width modulator (PWM) for encoding the amplitude of a signal to the pulse width or duration of another signal for transmission, and a universal asynchronous receiver-transmitter that acts as an interface for exchanging data with communication modules and other serial devices are incorporated for sending and receiving data. In other examples, a Bluetooth Low Energy (BLE) module may be incorporated to communicate with other BLE-enabled devices, such as smartphones, laptops, or tablets, using BLE signals. In some examples, an integrated chip is incorporated into the electrical connector assembly, and the integrated chip may include one or more modules, such as a communication module.

[0099] In one example, data transmitted by an electrical connector assembly can be communicated to a dedicated gateway that has both a BLE module for receiving data from the electrical connector assembly via Bluetooth communication and a Wi-Fi module for communicating the collected data to the cloud. This can be understood as cloud computing, which users can access from anywhere via the internet. Once stored in the cloud, users can access the stored information and view and analyze the collected data using a computing device or a handheld device such as a tablet or smartphone.

[0100] A local display unit can be provided to view, read, and / or analyze data collected from an electrical connector assembly. In one example, a mobile viewing station, including a mobile platform such as a mobile wheeled desk station, comprises a monitor and a computing device such as a computer or laptop programmed to view and process data received from the electrical connector assembly. In another example, a tablet may be used by a physician to view and process data received from the electrical connector assembly. The computing device may include a wireless transceiver module, a CPU, memory, a display screen or area, and a power supply to power the CPU and display screen. In some examples, a dedicated hub with memory can be placed with the electrical connector assembly to collect data. The dedicated hub has wired or wireless connectivity and allows the information it contains to be uploaded and made accessible to users such as physicians, nurses, and caregivers. Using a mobile viewing station with a CPU and monitor, one can move from one patient room to another and access the data from the dedicated hub to check and analyze the patient's condition and the status of the equipment.

[0101] In a further example, an IV catheter system includes a catheter assembly and electronic equipment for monitoring the patient's condition and / or the status of the peripheral venous catheter of the present invention. The electronic connector assembly may not have an integrated power supply. Instead, a removable power supply or module may be provided to supply power to the electrical connector assembly. The removable power supply module may include a rechargeable battery having a light indicator for indicating the power level and firmware for controlling the power charging function. A pin connector may be provided to connect the power output of the battery to the electrical connector assembly.

[0102] Another alternative embodiment of the catheter tube may have a body having a distal opening and a proximal opening for receiving a metal bushing for securing the proximal portion inside a catheter hub, such as one of the catheter hubs described elsewhere herein. In one example, the interior of the tube body may be partially or completely lined with a polypyrrole sensing material for the inside of a conventional catheter tube, such as one made from polyurethane (PU) material. For example, the annular space of the catheter tube body may be lined with a polypyrrole sensing material for use in detecting one or more of the following: temperature, blood flow, blood pressure, blood oxygen level, pH value, catheter occlusion, etc. In this embodiment, the sensing material includes a plurality of spaced or individual sensors distributed along the length of the catheter tube, preferably embedded in the wall of the catheter tube. For example, each individual sensor may embody a ring-shaped, circular, elliptical, or polygonal polypyrrole sensing material to enable sensing at discrete points along the catheter tube. The plurality of individual sensors may also embody a web of polypyrrole sensing material for sensing at individual points along the catheter tube. Individual sensors can be connected by individual conductive traces or conductors, or they can be interconnected via other sensing materials.

[0103] When used herein, discrete sensors have separate electronic output paths coupled in parallel to a data processing module so as not to corrupt data from one sensor with data from another. This allows each sensor to collect data independently from other sensors, even if each sensor is replaceable by another, so that the data processing module or computer system can compare data between multiple sensors in the same catheter system. In some embodiments, a catheter tube may include multiple separate sensors of different types as well as different outputs. For example, separate sensors may include both temperature sensors and pH sensors, and / or even pressure sensors. In some embodiments, different types of sensors can be grouped together; for example, sensors in the first third of the catheter tube may be temperature sensors, sensors in the next third may be pH sensors, and sensors in the last third may be pressure sensors. The outputs of all sensors within a single catheter tube are preferably connected to a common bus, such as an A / D converter bus or processor bus, so that the processor can organize the data into a queue for transfer via transceivers.

[0104] In another example, a catheter tube may have one or more individual sensors impregnated or embedded in its wall layer. The proximal portion of the catheter tube may be made of a conductive metallic material for connecting to other electronic modules such as a power supply and a radio signal transmitter that receive signals from the individual sensors and convert them into electricity using heat. In some examples, the proximal portion may be made of a conductive polymer material, also known as an intrinsically conductive polymer (ICP). ICP is an organic polymer known to conduct electricity. In yet another example, as described elsewhere in this specification, an optical fiber sensor may be used to transmit information from the individual sensors to an electrical connector assembly.

[0105] Individual sensors can be positioned along the length of the catheter tube. In some examples, individual sensors can extend between 10% and 100% of the length of the catheter tube, with 20% to 90% being more preferable. Individual sensors can be positioned at equal intervals along the length of the catheter tube, or at random intervals along the length of the catheter tube. Here, each sensor has two individual sensor inputs, one on the top surface of the catheter tube and the other on the bottom surface of the catheter tube, both connected to an output bus. A wire can be a bus that transmits each sensor output individually. In some embodiments, each set of upper / lower sensors can be coupled to a common bus terminal, and in other embodiments, each set of upper / lower sensors can be coupled to separate bus terminals so that a data processor can compare sensor data between sensors on the top and bottom surfaces of the catheter tube.

[0106] By coupling data sensors to a bus, a data processor can compare sensor data with each other, such as the temperature at one point in the catheter tube and the temperature at another point in the catheter tube. This is particularly useful in embodiments with catheter tubes longer than a few inches, such as a one-foot or two-foot catheter tube. A data processing module receiving sensor data can collect additional data metrics, such as pH or temperature differences between different points along the length of the catheter tube, through comparative analysis of the received sensor data.

[0107] Another alternative catheter assembly includes a conductor that directly or indirectly contacts the sensor within the catheter tube. The conductor can be used as an extension or connector for coupling the sensor within the catheter tube to an electrical connector assembly that includes a connector, an electrical module, and a cover. In one embodiment, the conductor may be one of a receptacle or a plug and has a receiving end which may be a distal end that extends into the catheter tube and connects to the sensor at some point within the catheter tube. The other receptacle or plug can be attached to the tip of the connector. The receptacle connects to the plug to provide an electrical path between the conductor and the electrical module. In one example, the conductor may instead be an optical fiber sensor for transmitting a signal from the sensor to the electrical connector assembly.

[0108] A catheter assembly equipped with a sensor may include a catheter hub comprising a hub body having a pair of wings and a catheter tube attached to the distal end of the hub body, extending distally and ending with a tapered distal opening. The hub body has a first hub portion and a second hub portion, which may be referred to as the distal hub portion and the proximal hub portion, respectively.

[0109] The electrical connector assembly is screwed to the proximal hub portion, or second hub portion, of the catheter hub. The electrical connector assembly comprises a connector housing having a distal end and a proximal end. In one example, the distal end includes a collar for receiving a sensor module, which has a collar for screwing into the male threads of the proximal hub portion. The connector housing has an elongated open end at the proximal end for receiving a male Luer tip, such as an IV connector or syringe tip. In one example, the elongated open end may be a threaded female Luer. The electrical connector assembly can be separated from the catheter hub by unscrewing the collar from the second hub portion of the catheter hub.

[0110] The connector housing of an electrical connector assembly may have an inlet, a threaded female Luer connector at the inlet, and a collar at the opposite end. In one example, the collar is a slip-on collar for receiving a sensor module without threading. The connector housing has a body made of thermoplastic material, a body having a wall structure that forms an internal bore (hole) that is sized and shaped to receive an elastic piston, and a shoulder portion positioned between the inlet and the body.

[0111] A piston that can be fitted into the bore of the housing is made of silicone material and may have a head portion, a neck portion, a shoulder portion, a body portion, and an expanding base which may resemble a flange. The body portion and optionally the shoulder portion can be hollow so that when the piston is positioned inside the housing and pressed by a male tip inserted into the open proximal end of the housing, the piston collapses against the constraint of the sensor module. When the male tip is removed from the open proximal end, the piston expands or returns to its unpressed state so that the piston head expands into the inner bore of the inlet portion, blocking the inlet opening from the flow of fluid.

[0112] In one example, the combination of the sensor module housing, piston, and end fitting resembles a female needleless connector. In a specific example, the combination of the sensor module housing, piston, and end fitting resembles a female needleless connector disclosed in U.S. Patent No. 7,591,449, which is housed within a housing and, in other embodiments, discloses a piston including a Y-slit. The combination of the sensor module housing, piston, and end fitting resembles a female needleless connector disclosed in U.S. Patent No. 9,695,953, which is housed within a wedge and, in other embodiments, discloses a piston including a spiral cut. U.S. Patents No. 7,591,449 and No. 9,695,953 are expressly incorporated herein by reference.

[0113] The sensor module may include a central conduit having a bore for fluid flow and multiple sensors, which may be the same as other sensors described elsewhere in this specification. The central conduit may extend from a male luer and may form a luer fit with the inlet of the proximal hub portion of the catheter hub. A threaded collar surrounds the male luer and is sized and shaped to screw into the male threads of the proximal hub portion of the catheter hub.

[0114] The base drum is connected to a collar and has an outer diameter smaller than the outer diameter of the collar for insertion into the housing collar. The shoulder between the base drum and the sensor module collar is configured to press against or abut against the end of the housing collar. Multiple electrical leads are electrically coupled to multiple sensors by co-molding or insert molding, each having a radial portion and an axial portion. The radial portion of each lead allows the lead to extend radially along the length of the housing, and then axially, to contact the corresponding lead on the computing core.

[0115] The head drum extends from the base drum and has a landing and a projection. The projection is sized and shaped to protrude from the open end of the piston at the base, and the flange of the base is configured to press against the landing. Multiple fluid passages are provided through the head drum and are in fluid communication with the bore and male Luer connector of the central conduit. Thus, when the piston is in operation, fluid passages are provided between the inlet of the head and the annular space between the outer surface of the piston and the inner surface of the housing. The fluid passages are in fluid communication with the multiple passages in the head drum, as well as the bore and male Luer connector of the central conduit. The housing and sensor module can be more permanently fixed to each other by adhesive, welding, or both.

[0116] The computing core can be mounted around the outside of the housing of the main body. In one example, the computing core includes a body with a hollow center for placement above or around the housing. The body of the computing core can be made of a dielectric material and includes leads in the sensor module, traces or leads for connecting to the circuit and power supply mounted on the body. The power supply may include a rechargeable battery. In one example, the circuit may include components described elsewhere herein for use in relaying or processing sensed data from a sensor located in the sensor module to a remote server or processor. In one example, the computing core is detachable from the sensor module leads and housing. For example, the computing core may be detached for reuse after the catheter hub is discarded.

[0117] A protective cover can be provided to protect the computing core, various leads, and various circuits from potential damage and / or short circuits. The protective cover can be made of a non-conductive or dielectric material and can be placed on both the computing core and the housing. In one example, the protective cover can be made of silicone material or silicone rubber and can have enlarged pockets and a raised surface for placement on the computing core and housing without interfering with electrical signals and connections. Such enlarged pockets and a raised surface may allow the body to be positioned within the protective cover in a self-orienting manner. The protective cover has open ends for sliding the computing core and housing and can be made sufficiently flexible to facilitate installation.

[0118] During use, as with the needleless connectors disclosed in U.S. Patents No. 7,591,449 and 9,695,953, when a male medical device such as a syringe tip or IV connector is connected to the inlet of the housing, the piston is pushed in, opening a fluid path between the outer surface of the piston and the inner surface of the housing. The fluid path is also in fluid communication with the fluid path of the head drum and the bore of the central conduit of the sensor module. When the piston is pushed in as described, the fluid can flow from the proximal end of the housing into the catheter hub and catheter tube, such as during intravenous fluid administration, or the fluid can be drawn from the proximal end, for example into the barrel of a syringe.

[0119] When the male medical device is removed from the housing inlet, the piston expands, and the head is returned to the inner area of ​​the housing inlet, closing the inlet to prevent further fluid flow. The electrical connector assembly can be removed and reused after treatment or whenever the catheter hub is replaced with a new catheter.

[0120] A computing device can be efficiently connected to a catheter having multiple sensors by using a computing assembly that allows the computing core to electronically engage with one or more conductive outputs from sensors in a central conduit via a screw connection. In some embodiments, the computing core can be coupled to a single catheter hub, e.g., an intravenous catheter hub, a midline catheter hub, or certain peripherally inserted central catheters such as those disclosed in U.S. Patent No. 6,544,251. In a catheter having multiple hubs, e.g., a central venous catheter as disclosed in U.S. Patent No. 9,504,806 or U.S. Patent No. 6,723,084, each catheter hub may include a separate computing core configured to wirelessly transmit sensor data to a common computer system. A catheter having multiple hubs with secondary branches connected to a common main catheter branch preferably has one catheter hub with conductive buses coupled to sensors embedded in both the main and secondary branches of the catheter, while all other catheter hubs have conductive buses coupled only to sensors in the associated secondary branches of the catheter hub.

[0121] Methods for fabricating and using catheter assemblies equipped with sensors and their components as described herein are within the scope of the present invention. [Brief explanation of the drawing]

[0122] The features and other advantages of this apparatus, system, and method will be better understood by referring to the specification, claims, and accompanying drawings. [Figure 1] This is a schematic system diagram showing an intravenous catheter assembly for performing therapeutic infusion therapy with monitoring capabilities. [Figure 2] This is a bottom plan view of a catheter assembly with one or more sensors, but without a needle or needle hub. [Figure 3] The diagram shows a catheter hub with a catheter tube that penetrates the hand puncture site to gain access to a peripheral vein. [Figure 4] This is a perspective view of a catheter assembly with a multipart hub body, but without a needle or needle hub. [Figure 5] This is an exemplary needle hub and a cross-sectional side view of a needle having a modified outer shape that interacts with a needle guard for covering the tip of the needle. [Figure 6A] A diagram of a catheter tube to which sensor material has been applied is shown. [Figure 6B] A diagram of a catheter tube to which sensor material has been applied is shown. [Figure 6C] This is a cross-sectional end view of either a catheter tube or a catheter hub having one or more sensors embedded within its wall layer. [Figure 7] This diagram shows the sensing and transmission architecture of this system. [Figure 8A] An exemplary report that can be generated using the system of this disclosure is shown to obtain information on infusion therapy using a catheter assembly equipped with one or more sensors. [Figure 8B] An exemplary report that can be generated using the system of this disclosure is shown to obtain information on infusion therapy using a catheter assembly equipped with one or more sensors. [Figure 8C] An exemplary report that can be generated using the system of this disclosure is shown to obtain information on infusion therapy using a catheter assembly equipped with one or more sensors. [Figure 9A] This is a schematic diagram of a catheter assembly that includes sensors and an electrical connector assembly for collecting and transmitting data. [Figure 9B] This is a magnified view of an electrical connector. [Figure 10] This is a schematic diagram of a catheter assembly that includes sensors and an electrical connector assembly for collecting and transmitting data. [Figure 11] This is a schematic diagram of a catheter assembly that includes sensors and an electrical connector assembly for collecting and transmitting data. [Figure 12] This is a schematic diagram of a catheter assembly that includes a sensor and electrical connector assembly for collecting and transmitting data, and a catheter hub with a side port. [Figure 13] This is a schematic flowchart showing an IV catheter system, including a catheter assembly and electronic equipment for monitoring the condition. [Figure 14] This is a schematic flowchart showing an IV catheter system, including a catheter assembly and electronic equipment for monitoring the condition. [Figure 15A] A diagram of a catheter tube with individual sensors distributed along its length is shown. [Figure 15B] A diagram of a catheter tube with individual sensors distributed along its length is shown. [Figure 15C] A diagram of a catheter tube with individual sensors distributed along its length is shown. [Figure 15D] A diagram of a catheter tube with individual sensors distributed along its length is shown. [Figure 16] This is a schematic diagram of a catheter assembly that includes sensors and an electrical connector assembly for collecting and transmitting data. [Figure 17] This document illustrates an embodiment of an intravenous catheter assembly provided by a further aspect of the present invention. [Figure 18] This document illustrates an embodiment of an intravenous catheter assembly provided by a further aspect of the present invention. [Figure 19] This document illustrates an embodiment of an intravenous catheter assembly provided by a further aspect of the present invention. [Modes for carrying out the invention]

[0123] The detailed description below, in relation to the accompanying drawings, is intended as a description of current preferred embodiments of catheter devices or assemblies (e.g., central venous catheters, intravenous catheters, peripherally inserted central catheters, and midline catheters) that provide monitoring functions according to embodiments of the Device, System, and Method, and is not intended to represent the only forms in which the Device, System, and Method may be constructed or used. These catheter devices are also known or referred to as over-the-needle catheter devices. Unless the context indicates otherwise, different types of over-the-needle catheter devices may generally be referred to as catheter devices or assemblies. The description describes features and steps for constructing and using embodiments of the Device, System, and Method in relation to the illustrated embodiments. However, it should be understood that the same or equivalent functions and structures may be achieved by different embodiments, which are also intended to be encompassed within the spirit and scope of this disclosure. As shown elsewhere in this specification, similar element numbers are intended to indicate similar or similar elements or features.

[0124] Figure 1 shows a system 100 for performing therapeutic infusion therapy with monitoring capabilities according to an aspect of the present disclosure. In one example, the system 100 can monitor and record the patient's condition and / or the status of the peripheral venous catheter used to perform the treatment while the patient is receiving therapeutic infusion therapy. By recording and monitoring various conditions and statuses of the patient and / or catheter, important clinical information can be provided to the clinician so that the course of treatment can be modified or continued for optimal patient care. In some examples, various conditions can be tracked and recorded in real time to enable up-to-date feedback on the progress of the patient's treatment. In exemplary embodiments, the catheter device may be a central venous catheter, an intravenous catheter, a peripherally inserted central catheter ("PICC"), or something other than a peripheral venous catheter such as a median catheter. According to an aspect of the system 100, a catheter assembly 104 equipped with sensors comprises one or more sensors for monitoring the patient's condition and / or the status of the peripheral venous catheter. As used herein, “sensor” includes devices that convert sensed data into measurable electronic signals, such as a piezometer that converts sensed pressure data into a metric for measuring pressure, or a thermometer probe that converts measured current into a metric for measuring temperature. Sensors “mounted” to elements such as inside or outside a catheter hub or needle hub have an exposed input surface that shares the environment with the element. Sensors “embedded” within elements such as the wall of a needle or catheter tube have an input surface that may not be exposed (e.g., a temperature sensor that senses ambient temperature through the wall) or an input surface that may be exposed (e.g., a pH sensor that has an input surface that is in fluid communication with the inner or outer surface of the catheter tube).

[0125] In one example, the catheter assembly 104 may have at least one sensor for sensing and / or monitoring the patient's condition, such as body temperature, or for sensing and / or monitoring the internal or external environment of the catheter hub, such as flow or pressure. As will be further described below, one or more sensors may include, to give some non-limiting examples, accelerometers for detecting motion, pressure sensors, temperature sensors, position and humidity sensors, and may be used to measure and monitor blood flow, pulse, blood pressure, blood oxygen level, body temperature, local skin temperature, pH value, catheter occlusion, flow rate, etc. Depending on the size of a typical catheter assembly, the sensors may be appropriately sized and shaped accordingly and may be powered using body temperature. For example, a heat-to-electric converter may be used to charge a capacitor, which then powers the sensor for use in the device of the present disclosure. Alternatively or additionally, a flexible supercapacitor may be used to power the sensor. Flexible supercapacitors capable of storing electric charge using heat from the surroundings have been discovered and are described in U.S. Patent Application Publication 2014 / 0338715 and U.S. Patent Application Publication 2010 / 0051079. The power released from the flexible supercapacitor can be configured to power one or more sensors and associated modules, such as a communications module for transferring detected signals to a server, controller, or other module for further processing. In some embodiments, the flexible supercapacitor can be used to charge a battery or capacitor, which is then used to power one or more electronic devices, such as a sensor or processor.

[0126] Flexible supercapacitors are known to researchers and scientists and have been experimented with in connection with wearable electronic devices. These thermochargeable solid supercapacitors can be made from solid polymer electrolytes that generate a large thermal induction voltage from a heat source such as body temperature. This voltage can then initiate an electrochemical reaction in the electrolyte for charging. The capacitor can also use conventional capacitor charging methods. The sensor can be integrated into a wireless data transmission system to send data to a local electronic device used with an app, or to a cloud server via a Wi-Fi gateway, which can then be viewed, recorded, trend analyzed, and analyzed using a web browser dashboard. In a preferred embodiment, the flexible supercapacitor is coupled to an element of a catheter directly connected to the patient, such as the wings 150a or 150b of a catheter hub 110, or to a portion of a catheter tube 152.

[0127] Referring again to system 100 in Figure 1, the catheter assembly 104 with sensors can embody catheter devices such as those shown in U.S. Patent Nos. 8,382,721, 8,540,728, and 8,597,249, the contents of which are expressly incorporated herein by reference. The catheter assembly 104 may include one or more sensors 106 arranged with the catheter hub 110, the needle hub 112, or both. Depending on the state to be sensed and the type of data to be acquired, the sensors may be located inside the catheter hub and needle hub, and / or outside the catheter hub and needle hub. In some examples, a needle guard may be provided with the catheter assembly 104 and may be located outside the catheter hub, such as in a third housing located between the catheter hub and the needle hub. In other examples, the needle may be covered after successful venipuncture using a spring-fed needle hub with a pushable tab that pushes the needle into a protective barrel or sheath.

[0128] One or more sensors 106 can be integrated with a Bluetooth Low Energy (BLE) module 114 to communicate with a local smart device 120 equipped with Bluetooth connectivity, and data sensed or acquired by the one or more sensors 106 can be communicated to the local smart device. The local smart device 120 may include a server, laptop computer, desktop computer, handheld device such as a smartphone or tablet, or a combination thereof. Custom program software can be provided to the local smart device 120 to process and display the sensed data, and to manipulate the data for viewing and reporting any number of times for purposes such as identifying trends, tracking high or low setpoints. Because the range of Bluetooth communication is limited, the local smart device is usually placed within 15-20 meters of the catheter assembly to ensure a strong wireless connection between the catheter assembly 104 and the smart device 120.

[0129] Alternatively or additionally, the catheter assembly 104 can communicate with a cloud server 130 via a gateway 140, which can be dedicated to the catheter system. In one example, the gateway 140 can incorporate both a BLE module 142 and a Wi-Fi module 144. Communication between the catheter assembly 104 and the gateway 140 can be done via a BLE connection, and communication between the gateway 140 and the cloud server 130 can be done via Wi-Fi, such as communicating with a router using Wi-Fi and then communicating with the cloud. Thus, data sensed, collected, or acquired by one or more sensors in the catheter assembly 104 can be transmitted to the cloud server 130 via the gateway 140 for recording, monitoring, analysis, and / or viewing. In some examples, a BLE mesh network can be provided to extend the range between the catheter assembly 104 and the gateway 140. In one example, the cloud server can be provided with data analysis and a web browser dashboard to analyze the uploaded data for available information, identifying trends, patterns, and causal relationships of various detected states. The report can be generated from the uploaded and collected information in the form of a bar graph as shown in Figure 8A, a line graph as shown in Figure 8B, or a text or written report as shown in Figure 8C, or a combination thereof.

[0130] Individuals authorized by clinicians or patients can access data stored on the cloud server 130 from anywhere with an internet connection, using a web browser dashboard and smart device 120, as stipulated by health and hospital policies. Appropriate security and authentication may be required before clinicians and authorized users can access the stored data.

[0131] Referring here to Figure 2, the catheter hub 110 is shown viewed from the bottom of a pair of wings 150a, 150b with the needle and needle hub removed. The catheter hub 110 has a catheter tube 152 attached to the distal end of the hub body 156, and at the opposite end, a proximal inlet or opening 154 having a Luer taper for receiving a male Luer tip such as a male infusion line, syringe, or male Luer adapter. As will be discussed further below, one or more sensors 106 can be incorporated with the catheter assembly 104 of this embodiment in the catheter tube 152, the hub body 156 of the catheter hub 110, the wings 150a, 150b, or a combination thereof. One or more sensors 106 can be located inside the hub body, inside the catheter tube, outside the hub body, outside the wings, embedded in the wall of the hub body, or a combination thereof.

[0132] Figure 3 is a schematic diagram showing a catheter hub 110 positioned in fluid communication with a peripheral vein in the patient's hand 160 at a puncture site 162, without a fluid line connected to the catheter hub. In some examples, the puncture site may be in the forearm or another location, for example, near the chest for a central venous catheter, or in the upper arm region for a PICC or median catheter, rather than connected to a peripheral vein in the hand. The catheter hub 110 can be secured to the hand 160 using a medical bandage 164, shown by a dashed line, which is fixed to the hand with adhesive. Alternatively or additionally, the medical bandage 164 can be incorporated into wings 150a, 150b without using adhesive, tape, or bandage separately to secure the catheter hub to the hand. One or more sensors of this disclosure may be mounted externally to the catheter hub, such as when an accelerometer is mounted on the wing to detect movement of the catheter hub or hand. In other examples, sensors may be mounted inside the catheter hub, on the wall of the catheter hub, or in the lumen of the catheter tube to detect patient conditions such as pH, oxygen levels, or local temperature.

[0133] In some cases, the electronic components of this system can be located both inside and outside the catheter hub and catheter tube. For example, both the wireless module and the power module can be located outside the catheter hub to supply power to various sensors and modules, or to transmit collected signals to a local smart device or cloud server. Thus, sensors mounted inside the hub body are in fluid communication with the fluids passing through the catheter hub, including intravenous fluids and blood, while other modules, such as non-sensor modules, can be located outside and are not exposed to any wet or liquid environments.

[0134] As will be further explained below, one or more sensors 106 can be coupled to the catheter hub to sense, detect, and / or monitor various conditions relating to the patient, such as body temperature or local temperature, blood temperature, blood pH level, and / or the status of the catheter hub 104, such as whether the hub body 156 has moved (e.g., by triggering an alert when an accelerometer detects directional movement), or whether flow has been detected through the catheter hub (e.g., by measuring flow rate or pressure). Thus, the catheter assembly 104, such as the catheter hub 110 of the catheter assembly, can not only be configured to function as a medium for fluid infusion therapy, but can also include one or more sensors to provide data on several different conditions that can be used by clinicians to evaluate the effectiveness of the infusion therapy and various other aspects.

[0135] Referring here to Figure 4, a perspective view of the catheter hub 110 is shown with wings of a further different shape. The catheter hub 110 is shown together with a hub body 156 having a first hub portion 166a attached to a second hub portion 166b. In this embodiment, the two hub body portions provide convenient access to the interior of the hub body 156, facilitating the installation of one or more sensors 106 and, optionally, other components such as valves and valve openers into the hub body. After installing one or more sensors and, where applicable, valves, valve openers, and needle guards, the two hub body portions can be joined and secured to each other by adhesive, bonding, welding, or a combination thereof.

[0136] A catheter tube 152 is shown attached to the distal end of the first hub portion 166a using conventional means such as a metal bushing. In some examples, the catheter hub 110 may be an integrated infusion catheter having a lateral fluid port extending from the hub body and a tube attached to the fluid port, and a fluid adapter such as a needleless connector attached to the opposite end of the tube. Baffles may be located inside the hub body of the integrated infusion catheter, proximal to the fluid port, and distal to the proximal catheter hub opening. In alternative embodiments, the catheter hub may include a single-formed port, also called a ported catheter, for directly receiving a male Luer tip without a flexible tube.

[0137] Figure 5 is a schematic cross-sectional view of a needle hub 112, which is removed from the catheter hub 110 in Figure 4 after successful venipuncture, etc. The needle hub 112 has a needle hub body 179 that forms an internal flashback chamber 180 with a proximal opening 182, usually fitted with a vent plug (not shown), to prevent blood flashback from leaking from the proximal opening. One or more sensors can be placed inside the needle hub body 179 or elsewhere with the needle hub 112 to sense the state of the blood, such as oxygen or pH level.

[0138] The needle guard or tip protector 190 is shown at the distal end of the needle 174 and surrounds or blocks the tip 176 of the needle. Embodiments of the needle guard are disclosed in U.S. Patents No. 8,382,721, 8,540,728, and 8,597,249 and are incorporated by reference. In some examples, other needle safety devices or guards to prevent accidental needle sticks can be used with a catheter assembly equipped with one or more sensors. For example, a spring-driven needle assembly can be activated to push a shield to cover the needle in a protected position after use, or to push the needle into a fixed outer protective barrel used to cover the tip of a used needle.

[0139] Referring here to Figures 6A and 6B, the catheter tube 152 is shown from different viewpoints. The catheter tube 152 has a body 192 with a distal opening 194 and an enlarged proximal portion 196 having a proximal opening 198 for receiving a metal bushing for securing the proximal portion inside the catheter hub, which is conventional. In one example, the interior of the tube body 192 can be partially or completely lined with polypyrrole sensing material. For example, the annular space of the catheter tube body 192 can be lined with polypyrrole sensing material for use in detecting one or more of the following: temperature, blood flow, blood pressure, blood oxygen level, pH value, catheter occlusion, etc. In one example, the inner layer of the sensing material can form a full circumference inside the outer catheter body material and can extend the length of the catheter tube or a portion of the length of the catheter tube.

[0140] Figure 6C is a schematic cross-sectional end view of a structure that may be a catheter tube 152 or catheter hub 156. As shown, the body of the catheter tube 152 or catheter hub 156 may have one or more sensors 106 impregnated or embedded in its wall layer. The proximal portion 196 of the catheter tube may be made of a conductive metallic material for connecting to other electronic modules such as a power supply and a wireless signal transmitter that acquire signals from the sensing material and convert them into electricity using heat. In some examples, the proximal portion 196 may be made of a conductive polymer material, also known as an intrinsically conductive polymer (ICP). ICPs are organic polymers known to conduct electricity.

[0141] Referring now to Figure 7, a diagram illustrating the sensing and transmission architecture of this system is shown. In one example, system 200 includes a sensing module 212, a data processing module 214, and a communication module 216, which can be located on the catheter assembly 104 or across several platforms, such as the catheter assembly and nearby peripherals. Although not shown, a power supply module using thermal-to-electrical conversion is incorporated to supply energy to the various sensors.

[0142] The sensing module 212 may comprise one or more individual sensors 106 for detecting any of the various parameters and conditions described elsewhere in this specification. Individual sensors may be located inside the catheter body, in the lumen of the catheter tube, and / or inside the needle hub. Individual sensors may also be mounted externally to the catheter hub body, such as on the wings of the catheter hub, the hub body, and / or a medical bandage. For example, an accelerometer may be mounted on the wings of the catheter hub to detect motion, and a temperature sensor may be used to detect the patient's surface skin temperature or local temperature.

[0143] The sensing module 212 may include an analog-to-digital converter 220 (A / D converter) for converting analog signals to digital signals. Optionally, the analog signals may be transmitted directly to a smart device or cloud server via a communication module for processing, conversion, and manipulation at a location away from the catheter assembly or remotely. For example, the analog-to-digital conversion can be performed on the cloud server. This enables the system of this disclosure to operate with low power requirements and may allow for low-cost implementation if the analog-to-digital conversion can be processed elsewhere.

[0144] The system 200 may include a data processing module 214 having a controller 222 which may include a microcontroller and / or microprocessor, embodied on a printed circuit board (PCB). The data processing module 214 may be provided with firmware and software that processes digital signals from an A / D converter and performs one or more functions related to the processed signals, such as transmitting signals to a smart device or transmitting signals to a cloud server via a gateway. Optionally, data processing may be performed by a smart device or by data analysis on a cloud server. In a preferred embodiment, the data processing module simply functions as a data queue that transmits sensor data to a transmitter, preferably a wireless transmitter such as a wireless communication 216. The data processing module 214 preferably has temporary or non-temporary memory that stores data received from one or more sensors and transmits them to a cloud server 130 or a remote computer system capable of processing the data, such as a local smart device 120 (Figure 1). In a preferred embodiment, the data processing module 214 adds a unique label to each data segment that uniquely identifies sensors, such as a temperature sensor in a catheter tube and a temperature sensor in a catheter hub, so that the receiving computer system can classify the sensor data accordingly. Such labels can be added using appropriate means, such as XML (Extensible Metalanguage) format. For example, each packet transmitted from the transceiver may include a timestamp, a set of sensor metrics, the type of each sensor, and a unique identifier for each sensor. The unique identifier could be a location or position within the catheter, allowing the data processing system to calculate the distance between at least two sensors.

[0145] Next, the remote computer system can process the sensor data and perform appropriate analysis on the data, such as compiling a data report or triggering an alert when data threshold metrics are exceeded, such as blood temperature exceeding or falling below a threshold, or blood flow exceeding or falling below a threshold. In some embodiments, the data processing module 214 may be configured to perform such analysis, such as triggering an LED light on the catheter when a predetermined threshold is reached. In a preferred embodiment, data from multiple sensors can be analyzed to create metrics, for example, data metrics from a first temperature sensor at a first location and a second temperature sensor at a second location can be used to calculate the temperature difference between blood measured from the first location to the second location.

[0146] The system 200 may include a data communication module 216 for communicating the sensed signals to a smart device or cloud server using any suitable wireless transceiver such as a BLE-connected device and Wi-Fi. Using data analysis, the signals can be displayed on a PC, laptop, or mobile device via charts, tables, and / or reports.

[0147] Sensors described elsewhere in this specification may be made from materials that may include polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoityl (PAN). One or more sensors incorporated into a catheter assembly or its components in this embodiment may be connected physically or wirelessly to a wireless data transmission component such as a BLE module to transfer the collected data to a smart device or cloud server used by a data analysis, app, or web browser dashboard for analysis of the uploaded data with respect to usable information, such as assembling trends, patterns, and causal relationships of various detected states. In some examples, fiber optic sensors may be used as sensing elements also known as intrinsic sensors, or as means for relaying signals from remote sensors to electronic devices that process signals, also known as extrinsic sensors. Fiber optic sensors may be used to measure strain, temperature, pressure, and other quantities. Thus, aspects of this disclosure are understood to include the use of fiber optic sensors for both intrinsic sensor purposes, extrinsic sensor purposes, or both purposes.

[0148] With respect to catheter assemblies comprising sensors and assembly components disclosed herein, if features are shown but not explicitly described, and otherwise the features are the same or similar to one or more features described elsewhere, as in the above description with reference to Figures 1-7, then any disclosed portion shown in all drawings but not explicitly described for the sake of redundancy or because the knowledge is built upon a foundation established by prior disclosures, it is understood that such one or more features are still described or taught by the same or similar features as those explicitly described in the text of the embodiments in which they are described. In other words, subsequent disclosures of this application are built upon the foundations of prior disclosures unless the context indicates otherwise.

[0149] Therefore, it is understood that this disclosure teaches the disclosed embodiments and features of the disclosed embodiments to those skilled in the art without the need to repeat similar parts and features in all embodiments, since skilled in the art will not disregard similar structural features that they have just read about in some preceding paragraphs, nor will they ignore the knowledge gained from previous descriptions in the same specification. Accordingly, the same or similar features shown in the following catheter assemblies incorporate teachings from previous embodiments unless the context indicates otherwise. Accordingly, unless the context indicates otherwise, later disclosed embodiments are intended to enjoy the advantages of earlier explicitly described embodiments, such as the features and structures of the earlier described embodiments.

[0150] Referring here to Figure 9A, a schematic cross-sectional side view of an alternative catheter assembly 104 is shown together with the catheter hub 110. The catheter assembly 104 is shown without the needle hub and needle for clarity, but is understood to be part of a catheter assembly for use in obtaining intravenous access. The needle can be replaced by a stylet or a solid needle shaft. In some examples, a guidewire is used with the catheter assembly to help guide the placement of the catheter tube. As shown, the catheter hub 110 has a catheter hub body 156 and a catheter tube 152 having a tube body 192 attached to the hub body by a metal bushing 250 or the like. In one example, the interior of the tube body 192 can be partially or completely lined with a sensing material 106, such as polypyrrole sensing material. For example, the annular space of the catheter tube body 192 can be lined with polypyrrole sensing material 106 for use in detecting one or more of the following: temperature, blood flow, blood pressure, blood oxygen level, pH value, catheter occlusion, etc. In some cases, the sensor 106 can be embedded inside the thickness of the catheter tube, as shown in Figure 6C.

[0151] Similar to the catheter tube 152 described with reference to Figures 6A and 6B, the catheter tube has a body 192 with a distal opening 194 and a proximal portion 196 made of a conductive material. In some embodiments, the body 92 may include one or more sensors embedded in insulating material that are electronically coupled to the conductive proximal portion 196 via an insulating path, so that the conductive proximal portion can contact an input port of an electronic device, such as an input to an A / D converter or data processing module. Alternatively, the proximal portion may be made of a polymer material and lined with a sensing or conductive material, as will be discussed further below. The distal opening 194 may have a reduced opening compared to the rest of the catheter tube to form a seal around the needle shaft or stylet. The proximal portion 196 of the catheter tube 152 may be made of a conductive material for connecting to other electronic modules, such as a power supply and a wireless signal transmitter, which receive signals from the sensing material 106 lining the inside of the tube body 192 and convert them into power using heat. Alternatively, the sensing material may extend beyond the proximal portion 196, and an electrical connector may be used to connect the sensor 106 to another device.

[0152] In some examples, the proximal portion 196 can be made from a conductive polymer material also known as an intrinsically conductive polymer (ICP). ICP is an organic polymer known to conduct electricity. The sensor material can be made from a material that may include polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoityl (PAN). In some examples, the sensing material 106 of the tube body and the sensing material of the proximal portion 196 of the catheter tube 152 may be formed integrally or as a single unit.

[0153] Referring further to Figure 9B in addition to Figure 9A, enlarged views are shown of the connection between the sensor 106 and the catheter tube 152, and the connection between the conductor 290 and the catheter hub body 156. In one example, electrical communication between the sensor 106 located in the catheter tube 192 and the conductor 290 located in the catheter hub 110 can be provided via or by using an electrical connector 260. In one example, the electrical connector 260 is made from a conductive polymer material such as ICP, polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoyl (PAN). In other examples, the electrical connector 260 is made from a conductive metallic material such as copper, brass, or an alloy thereof. Alternatively, one or more optical fibers can be used for the sensor 106 and / or conductor 290 as described above.

[0154] The connector 260 may have a body portion 262 and a flange portion 264, with a gap 266 between them. The body portion 262 may contact or wedge with the sensor 106 together with the catheter hub 110. A portion of the sensor 106 with the catheter tube 152 can be positioned in the gap 266. When the metal bushing 250 (Figure 9A) is pressed into the catheter hub 110 and the catheter tube 152 is wedge between the catheter hub and the metal bushing, the flange 264 clamps the proximal end of the catheter tube sensor 106 on the catheter hub and the body portion 262 of the electrical connector 260.

[0155] In one example, the catheter tube sensor 106 has a proximal end 270 that is longer than the proximal end of the catheter tube body 192, and as a result, the folded portion 272 of the catheter tube sensor 106 folds around the outside of the catheter tube body and makes direct contact with the body portion 262 of the connector 260. This folded portion 272 allows the catheter tube sensor 106 to make direct contact with the body portion 262 of the connector, as well as by contact with the flange 264.

[0156] Referring again to Figure 9A, an electronic connector assembly 280 is shown attached to the proximal end of the catheter hub body 156. The electronic connector assembly 280 may include a connector housing 282 and an electrical module 284. The connector housing 282 may be attached to the proximal end of the catheter hub 110 to house the electronic module 284 for use with the sensor 106 and conductor 290. In some examples, an optical fiber sensor may be attached to the catheter tube and coupled to the connector assembly 280. The connector housing 282 may be made of a thermoplastic material and may have a male tip 292 for insertion into the proximal opening of the catheter hub 110 and a threaded collar for screw-in engagement with the male thread in the catheter hub 110. In other examples, the connector housing 282 may be fixed to the catheter hub 110 using various fastening means such as adhesive, locking, bonding, welding, or a combination thereof. The connector housing 282 may be elongated and may have a Luer taper for receiving the male Luer tip 286 and may include a male thread 288 for screw-in Luer connection.

[0157] Conductor 290 can also extend outside the body of connector 282, presenting a surface for contact with conductor 290 attached to catheter hub 110. The male tip 292 of connector 282 can be sized and shaped to wedge the two conductors 290, 290 tightly into contact and seal their interface from fluid flow. Contact between conductor 290 at the interface between catheter hub and electronic connector assembly 280 enables electrical communication between electrical module 284 and sensor 106 on catheter tube. In one example, as described elsewhere in this specification, the electronic module 284 may include a sensing interface, a communication interface, and a power supply. A cover 296 can be provided around the electrical module 284 to seal the module from damage or unwanted exposure. In one example, the cover 296 may be a silicone material or a coat or layer of sleeve.

[0158] Referring here to Figure 10, another alternative catheter assembly 104 is shown, similar to the catheter assembly in Figure 9A, but without the needle and needle hub. In this embodiment, the conductor 300 is in direct or indirect contact with the sensor 106 within the catheter tube 152. The conductor 300 can be used as an extension or coupling to connect the sensor 106 within the catheter tube to an electrical connector assembly 280, which includes a connector or connector housing 282, an electrical module 284, and a cover 296, similar to the electrical connector assembly 280 in Figure 9A. In this embodiment, the conductor 300 has a receiving end 304, which may be either a receptacle 306 or a plug 308. The tip 292 of the connector 282 can be fitted with the other of the receptacle 306 or the plug 308. The receptacle 306 connects to the plug 308 to provide an electrical path between the conductor 300 and the electrical module 284. Alternatively, the optical fiber sensor can be integrated into the catheter tube, and the sensor is connected to the electrical connector assembly 280 using an optical fiber. In one example, the electrical assembly 280 is detachable from the catheter hub 104 to disconnect the receptacle 306 and plug 308. The detachable configuration allows the electrical connector assembly 280 to be removed from the catheter hub and reused or used in another catheter assembly or for a different purpose.

[0159] Figure 11 shows another alternative catheter assembly 104, similar to the catheter assembly in Figure 9A, but without the needle and needle hub. However, in the electrical assembly, as in the electrical connector assembly 280 in Figure 10, the connector housing 282 is removable from the proximal end of the catheter hub. Removal is possible by providing a connection between the sensor 106 in the catheter tube and the conductor 290 of the electrical assembly 280 having the conductor 290 of the catheter hub 110. The connector 282 can be removablely secured to the catheter hub by screwing it in via a threaded collar of the connector that engages with the threads of the catheter hub using press-fit or contact mating.

[0160] Figure 12 shows another alternative catheter assembly 104, which is similar to the catheter assembly in Figure 9A with a few exceptions, but without the needle and needle hub. In this embodiment, the hub body 156 includes a side port 310 having a channel or flow path 312 that communicates fluidly with the internal cavity 314 of the catheter hub 110. Although not shown, a valve in the form of a sleeve can be placed inside the catheter hub to block the fluid path at the intersection of the channel 312 and the internal cavity 314. The sleeve prevents fluid from the internal cavity from leaking through the side port 310. However, the fluid pressure flowing through the side port 310 from a syringe or drip line, etc., can crush (fold) at least a portion of the sleeve, resulting in the fluid flowing into the channel 312, into the internal cavity 314, and out through the catheter tube. The valve and valve opener may be located in the proximal portion of the internal cavity, as previously discussed in other catheter embodiments. In some examples, the sleeve and valve may be a single or standalone structure. The valve can be positioned near a collapsible (compressible) sleeve.

[0161] As shown in Figure 12, the sensor 106 can be placed inside the catheter tube 152 for connection to the electrical connector assembly 280 via conductors located in the catheter hub body 156 and the side port 310. In one example, the sensor 106 may be formed separately inside the catheter tube and then connected to the electrical connector assembly 280 using a conductor. In some examples, an optical fiber can be used as an external sensor to relay the signal. Alternatively, the connector can be formed continuously using conductive polymer materials, polypyrrole, carbon nanotubes, glassy carbon, and polyacrylonoyl (PAN).

[0162] As shown, an electrical connector assembly 280, comprising a connector housing 282, an electrical module 284, and a cover 296, is shown mounted on the side port 310, similar to the electrical assembly 280 in Figure 9A. As in the electrical assembly 280 in Figure 10, the connector 282 in the electrical assembly 280 is removable from the side port 310 and can be refurbished or reused in another catheter hub. Removal is made possible by providing a connection between the sensor 106 and the conductor 290 of the electrical assembly 280, which is press-fit or contact-fit and is detachably secured by the connector 282 engaging with the side port 310 of the catheter hub, for example by screwing a threaded collar into the threads of the catheter hub.

[0163] Referring here to Figure 13, the schematic flowchart shows a catheter system 320 comprising a catheter assembly and electronic equipment for monitoring the patient's condition and / or the status of the catheter device of the present invention. The system includes a capillary or catheter tube of block 322 having one or more sensors, connected to the catheter hub body of block 324, to which connectors such as the electrical connector assembly 280 shown in Figures 9A to 12 are connected.

[0164] Block 326 shows electronic devices and components that may be incorporated into the electrical connector assembly 280 for sensing and monitoring various conditions and circumstances of a peripheral venous catheter and / or patient. As shown, the electronic devices may include an A / D converter for converting signals from one or more sensors attached to the catheter hub and / or catheter tube, as previously stated. The A / D converter can be powered from a power source that can be powered using body temperature. For example, a heat-to-electric converter can be used to charge a capacitor and power various components. A thermally charged solid supercapacitor can be made from a solid polymer electrolyte that can generate a large thermal induction voltage from a heat source such as body temperature to power electronic components. In some examples, the heat-to-electric converter can first charge a battery, which then powers the electronic components.

[0165] The electrical connector assembly may further include a processor, or CPU and memory, for storing and processing firmware and software. A pulse-width modulator (PWM) for encoding the amplitude of a signal to the pulse width or duration of another signal for transmission, and a universal asynchronous receiver-transmitter that acts as an interface for exchanging data with communication modules and other serial devices are incorporated for sending and receiving data. In other examples, a Bluetooth Low Energy (BLE) module may be incorporated to communicate with other BLE-enabled devices such as smartphones, laptops, or tablets using BLE signals. In some examples, an integrated chip is incorporated into the electrical connector assembly, and the integrated chip may include one or more modules, such as a communication module.

[0166] In one example, data transmitted by the electrical connector assembly in block 326 can be communicated to a dedicated gateway having both a BLE module for receiving data from the electrical connector assembly via Bluetooth communication and a Wi-Fi module for communicating the collected data to the cloud. This can be understood as cloud computing, which users can access from anywhere via the internet. Once stored in the cloud, users can access the stored information and view and analyze the collected data using a computing device or a handheld device such as a tablet or smartphone.

[0167] As shown in Figure 13, a local display unit can be provided in block 328 for viewing, reading, and / or analyzing data collected from the electrical connector assembly. In one example, a mobile viewing station, including a mobile platform such as a mobile wheeled desk station, includes a monitor and a computing device, such as a computer or laptop, programmed to view and process data received from the electrical connector assembly in block 326. As shown, the computing device may include a wireless transceiver module, a CPU, memory, a display screen or area, and a power supply to power the CPU and display screen. In some examples, a dedicated hub with memory can be located in block 326 together with the electrical connector assembly for data collection. The dedicated hub has wired or wireless connectivity and allows the uploading of the information it contains, making it accessible to users such as doctors, nurses, and caregivers. Using the mobile viewing station with a CPU and monitor, it is possible to move from one patient room to another and access the data from the dedicated hub to check and analyze the patient's condition and / or the status of the equipment.

[0168] Figure 14 shows an alternative schematic flowchart illustrating an IV catheter system 334 including a catheter assembly and electronic equipment for monitoring the patient's condition and / or the status of the peripheral venous catheter of the present invention. The system in Figure 14 is similar to the system in Figure 13, except that the electronic connector assembly in block 326a does not have an integrated power supply. Instead, a removable power supply or module for supplying power to the electrical connector assembly is provided in block 326b. The removable power supply module may include a rechargeable battery having a light indicator for indicating the power level and firmware for controlling the power charging function. A pin connector may be provided to connect the power output of the battery to the electrical connector assembly.

[0169] Referring here to Figures 15A to 15D, another alternative embodiment of the catheter tube 152 is shown in perspective, section, or end view, side view, and top view, respectively. The catheter tube 152 has a body 192 having a distal opening 194 and a proximal opening 198 for receiving a metal bushing for securing the proximal portion inside a catheter hub, such as one of the catheter hubs described elsewhere herein. In one example, the interior of the tube body 192 may be partially or completely lined with a polypyrrole sensing material 106 for the inside of a conventional catheter tube, such as one made from polyurethane (PU) material. For example, the annular space of the catheter tube body 192 may be lined with a polypyrrole sensing material for use in detecting one or more of the following: temperature, blood flow, blood pressure, blood oxygen level, pH value, catheter occlusion, etc., as in the embodiments of Figures 6A to 6C. In this embodiment, the sensing material 106 includes a plurality of spaced or individual sensors 106a distributed along the length of the catheter tube 152, preferably embedded within the wall of the catheter tube, as shown in Figure 6C. For example, each individual sensor 106a can embody a ring-shaped, circular, elliptical, or polygonal polypyrrole sensing material to enable sensing at discrete points along the catheter tube. The plurality of individual sensors 106a can also embody a web of polypyrrole sensing material for sensing at individual points along the catheter tube. The individual sensors can be coupled with individual conductive traces or conductors, or interconnected via other sensing materials.

[0170] When used herein, discrete sensors have separate electronic output paths coupled in parallel to a data processing module so as not to corrupt data from one sensor with data from another. This allows each sensor to collect data independently from other sensors, even if each sensor is replaceable by another, so that the data processing module or computer system can compare data between multiple sensors in the same catheter system. In some embodiments, a catheter tube may include multiple separate sensors of different types and different outputs. For example, the separate sensor 106a in Figure 15C may include both a temperature sensor and a pH sensor, and / or even a pressure sensor. In some embodiments, different types of sensors can be grouped together; for example, the first third of a catheter tube 152 may contain temperature sensors, the next third may contain pH sensors, and the last third may contain pressure sensors. The outputs of all sensors within a single catheter tube are preferably connected to a common bus, such as an A / D converter bus or processor bus, so that the processor can organize the data into a queue for transfer via transceivers.

[0171] Figure 15B is a cross-sectional end view of the catheter tube 152 of Figure 6A. As shown, the body of the catheter tube 152 may have one or more individual sensors 106a impregnated or embedded in its wall layer. The proximal portion 196 of the catheter tube may be made of a conductive metallic material for connecting to other electronic modules such as a power supply and a wireless signal transmitter that acquire signals from the individual sensors 106a and convert them into electricity using heat. In some examples, the proximal portion 196 may be made of a conductive polymer material, also known as an intrinsically conductive polymer (ICP). ICP is an organic polymer known to conduct electricity. In yet another example, as described elsewhere in this specification, an optical fiber sensor may be used to transmit information from the individual sensors to an electrical connector assembly 280.

[0172] Figures 15C and 15D are side and top views of the catheter tube of Figure 15A, respectively. Individual sensors 106a are shown arranged along the length of the catheter tube 152. In some examples, the individual sensors can extend between 10% and 100% of the length of the catheter tube, with 20% to 90% being more preferable. The individual sensors can be spaced equally along the length of the catheter tube or randomly spaced along the length of the catheter tube. Here, each sensor has two individual sensor inputs, one on the top surface of the catheter tube 152 and the other on the bottom surface of the catheter tube 152, both connected to an output bus. Wire 106b is preferably a bus that transmits each sensor output individually. In some embodiments, each set of upper / lower sensors 106a can be coupled to a common bus terminal, and in other embodiments, each set of upper / lower sensors 106a can be coupled to separate bus terminals so that a data processor can compare sensor data between sensors on the top and bottom surfaces of the catheter tube 152. By coupling data sensors to a bus, a data processor can compare sensor data with each other, such as the temperature at one point in the catheter tube and the temperature at another point in the catheter tube. This is particularly useful in embodiments with catheter tubes longer than a few inches, such as a one-foot or two-foot catheter tube. A data processing module receiving sensor data can collect additional data metrics, such as pH or temperature differences between different points along the length of the catheter tube, through comparative analysis of the received sensor data.

[0173] Referring here to Figure 16, another alternative catheter assembly 104 is shown, similar to the catheter assembly in Figure 10, but without the needle and needle hub. In this embodiment, the conductor 300 is in direct or indirect contact with the sensor 106 within the catheter tube 152. The conductor 300 can be used as an extension or coupling to connect the sensor 106 within the catheter tube to an electrical connector assembly 280, which includes a connector 282, an electrical module 284, and a cover 296, similar to the electrical connector assembly 280 in Figure 10. In this embodiment, the conductor 300 has a receiving end 304 which may be either a receptacle 306 or a plug 308, and which may be a distal end 388 extending into the catheter tube 152 and coupling with the sensor 106 at some point within the catheter tube. The tip 292 of the connector 282 can be fitted with the other of the receptacle 306 or the plug 308. The receptacle 306 connects to the plug 308 to provide an electrical path between the conductor 300 and the electrical module 284. In one example, the conductor 300 could instead be an optical fiber sensor for transmitting signals from the sensor 106 to the electrical connector assembly 280.

[0174] Referring here to Figure 17, a perspective view of a catheter assembly 104 with a sensor is shown, similar to other catheter assemblies described elsewhere in this specification and shown without a needle and needle hub, with a few exceptions. In this embodiment, the catheter hub 110 includes a hub body 156 having a pair of wings 150a, 150b, and a catheter tube 152 attached to the distal end of the hub body 156, extending distally and terminating at a tapered distal opening 104. The hub body 156 has a first hub portion 166a and a second hub portion 166b, which may be referred to as the distal hub portion and the proximal hub portion, respectively.

[0175] The electrical connector assembly 280 is screwed to the proximal hub portion, or second hub portion 166b, of the catheter hub 110. The electrical connector assembly 280 comprises a connector housing 282 having a distal end 350 and a proximal end 352. In one example, the distal end 350 includes a collar 358 for receiving a sensor module 390, which has a collar 398 for screwing into the male thread of the proximal hub portion 166b. The connector housing 282 has an elongated open end 360 at the proximal end 352 for receiving a male Luer tip, such as an IV connector or syringe tip. In one example, the elongated open end 360 may be a threaded female Luer. The electrical connector assembly 280 can be separated from the catheter hub 110 by unscrewing the collar 398 from the second hub portion 166b of the catheter hub 110.

[0176] Figure 18 shows a partial cross-sectional view of the catheter assembly 104 of Figure 17, and Figure 19 shows a diagram of the disassembled parts of the electrical connector assembly 280 of Figure 17. Referring here to Figures 18 and 19, and further to Figure 17, the connector housing 282 of the electrical connector assembly 280 is more clearly shown, which has an inlet 364, a threaded female Luer 360 at the inlet, and a collar 358 on the opposite side. In one example, the collar 358 is a slip-on collar for receiving a sensor module 390 without threading. The connector housing 282 has a body 370 made of thermoplastic material, which has a wall structure that forms an internal bore that is sized and shaped to receive an elastic piston 374, and a shoulder 366 positioned between the inlet 364 and the body 370.

[0177] A piston 374, which can be fitted into the bore of the housing 282, is made of silicone material and may comprise a head portion 376, a neck portion 378, a shoulder portion 380, a body portion 382, ​​and an expanding base 384 which may resemble a flange 386. The body portion 382 and optionally the shoulder portion 380 can be hollow so that when the piston is positioned inside the housing and pushed by a male tip inserted into the open proximal end 360 of the housing, the piston 374 collapses against the constraint of the sensor module 390. When the male tip is removed from the open proximal end 360, the piston 374 expands or returns to an unpressed state so that the head 376 of the piston 374 expands into the inner bore of the inlet portion 364, blocking the inlet opening 360 from the flow of fluid.

[0178] In one example, the combination of the housing 282, piston 374, and end fitting of the sensor module 390 resembles a female needleless connector. In a specific example, the combination of the housing 282, piston 374, and end fitting of the sensor module 390 is similar to a female needleless connector disclosed in U.S. Patent No. 7,591,449, which is housed within a housing and, in other embodiments, discloses a piston including a Y-slit. The combination of the housing 282, piston 374, and end fitting of the sensor module 390 is similar to a female needleless connector disclosed in U.S. Patent No. 9,695,953, which is housed within a housing and, in other embodiments, discloses a piston including a spiral cut. U.S. Patents No. 7,591,449 and No. 9,695,953 are expressly incorporated herein by reference.

[0179] The sensor module 390 shown includes a central conduit 394 having a bore (hole) for fluid flow and a plurality of sensors 106 which may be the same as other sensors described elsewhere in this specification. The central conduit 394 may extend from a male Luer 396 and may form a Luer fit with the inlet of the proximal hub portion 166b of the catheter hub 110. A threaded collar 398 surrounds the male Luer 396 and is sized and shaped to screw into the male thread of the proximal hub portion 166b of the catheter hub 110.

[0180] The base drum 404 is connected to the collar 398 and has an outer diameter smaller than the outer diameter of the collar 398 for insertion into the collar 358 of the housing 282. The shoulder portion 408 between the base drum 404 and the collar 398 of the sensor module 390 is configured to press against or abut the end 408 of the collar 358 of the housing 282. Multiple electrical leads 412 are electrically coupled to multiple sensors 106 by co-forming or insert molding, etc., each having a radial portion and an axial portion. The radial portion of each lead 412 allows the lead to extend radially and then axially along the length of the housing 282 (Figure 18) to contact the corresponding lead 418 in the computing core 420, as will be discussed further below.

[0181] The head drum 414 has a landing 416 and a projection 417 and extends from the base drum 404. The projection 417 is sized and shaped to project from the base 384 toward the open end of the piston 374, and the flange 422 of the base 384 is configured to press against the landing 416. Multiple flow channels 426 are provided through the head drum 414 and are in fluid communication with the bore 428 and male luer 396 of the central conduit 394. Thus, when the piston 374 is actuated, a flow channel is provided between the inlet in the head 376 and the annular space between the outer surface of the piston 374 and the inner surface of the housing 282. This flow channel is in fluid communication with the multiple flow channels 426 in the head drum 414, as well as the bore 428 and male luer 396 of the central conduit 394. The housing 282 and the sensor module 390 can be more permanently fixed to each other by adhesive, welding, or both.

[0182] The computing core 420 is a body portion 370 that can be mounted around the outside of the housing 282. In one example, the computing core 420 comprises a body 430 having a hollow center for placement above or around the housing 282. The body 430 of the computing core 420 can be made of a dielectric material and has traces or leads for connecting to the lead wires 412 in the sensor module 390 and to the circuit 438 and power supply 440 mounted on the body 430. The power supply 440 may include a rechargeable battery. In one example, the circuit 438 may include components described elsewhere herein, such as block 326 in Figure 13, used to relay or process sensed data from the sensor 106 located in the sensor module 390 to a remote server or processor. In one example, the computing core is detachable from the lead wires 412 of the sensor module 390 and the housing 282. For example, the computing core 420 may be detached for reuse after the catheter hub 110 is discarded.

[0183] A protective cover 444 may be provided to cover the computing core 420, various leads, and various circuits from potential damage and / or short circuits. The protective cover 444 may be made of a non-conductive or dielectric material and may be placed on both the computing core 444 and the housing 282. In one example, the protective cover 444 may be made of silicone material or silicone rubber and may have an enlarged pocket 446 and a raised surface 448 to be placed above the computing core 444 and housing 282 without interfering with electrical signals and connections. Such an enlarged pocket 446 and raised surface 448 may allow the body 420 to be placed within the protective cover 444 in a self-orienting manner. The protective cover 444 has an open end for sliding the computing core 444 and housing 282 and may be made sufficiently flexible to facilitate installation.

[0184] During use, as with the needleless connectors disclosed in U.S. Patents No. 7,591,449 and 9,695,953, when a male medical device such as a syringe tip or IV connector is connected to the inlet 364 of the housing 282, the piston 374 is pushed in, opening a fluid path between the outer surface of the piston 374 and the inner surface of the housing 282. The fluid path is also in fluid communication with the fluid path 426 of the head drum 414 and the bore 428 of the central conduit 394 of the sensor module 390. When the piston 374 is pushed in as described, the fluid can flow from the proximal end 352 of the housing 282 into the catheter hub 110 and catheter tube 152, such as during intravenous fluid administration, or the fluid can be drawn from the proximal end 352, for example, into the barrel of a syringe.

[0185] When the male medical device is removed from the housing inlet 364, the piston expands and the head 376 is returned to the inner area of ​​the housing inlet 364, closing the inlet to prevent further fluid flow. The electrical connector assembly 280 can be removed and reused after treatment or whenever the catheter hub is replaced with a new catheter.

[0186] A computing assembly that allows the computing core 444 to electronically engage with one or more conductive outputs from sensors 106 in a central conduit 394 via a screw connection could be used to efficiently connect a computing device to a catheter having multiple sensors. In some embodiments, the computing core can be coupled to a single catheter hub, e.g., an intravenous catheter hub, a midline catheter hub, or certain peripherally inserted central catheters such as those disclosed in U.S. Patent No. 6,544,251. In a catheter having multiple hubs, e.g., a central venous catheter as disclosed in U.S. Patent No. 9,504,806 or U.S. Patent No. 6,723,084, each catheter hub may include a separate computing core configured to wirelessly transmit sensor data to a common computer system. A catheter having multiple hubs with secondary branches connected to a common main catheter branch preferably has one catheter hub with conductive buses coupled to sensors embedded in both the main and secondary branches of the catheter, while all other catheter hubs have conductive buses coupled only to sensors in the associated secondary branches of the catheter hub.

[0187] Methods for fabricating and using catheter assemblies equipped with sensors and their components as described herein are within the scope of the present invention.

[0188] While limited embodiments of catheters equipped with monitoring functions and their components are specifically described and illustrated herein, many modifications and variations will be apparent to those skilled in the art. Furthermore, elements and features explicitly discussed in one embodiment but not in another may be equally applicable, provided that they do not contradict each other in function or structure. Thus, unless the context indicates otherwise, similar features in one embodiment are applicable to another. Therefore, it should be understood that safety needle assemblies and their components constructed in accordance with the principles of the disclosed devices, systems, and methods may be embodied in ways other than those specifically described herein. The disclosure is also defined in the following claims.

Claims

1. A catheter system (100), A catheter hub (110) including a hub body (156) having an external and internal structure, A catheter tube (152) having a lumen attached to a catheter hub (110), A sensor (106) is attached to at least one of the hub body (156) and the catheter tube (152) in order to sense the status of the catheter hub (110) or to monitor the patient's condition, A smart device (120) and at least one cloud server (130) for collecting data sensed by a sensor (106), A catheter system equipped with [a specific feature / feature].

2. The catheter system according to claim 1, wherein the sensor is a first sensor and is mounted inside the hub body.

3. The catheter system according to claim 1 or 2, further comprising a second sensor (106), the second sensor (106) being mounted externally to the hub body (156).

4. The catheter system according to claim 3, wherein a second sensor (106) is attached to wings (150a, 150b) extending from the hub body (156).

5. The catheter system according to claim 2, further comprising a second sensor (106), the second sensor (106) being attached to a catheter tube (152).

6. The catheter system according to any one of claims 1 to 5, further comprising a BLE module (114) electrically coupled to a sensor (106) and relaying the sensed data to a smart device (120) using a BLE connection.

7. A catheter system according to any one of claims 1 to 6, further comprising a BLE module (114) electrically coupled to a sensor (106), and a gateway (140) including a BLE module (142) and a Wi-Fi module (144).

8. The catheter system according to claim 7, wherein the sensed data is collected by a cloud server (130) via a Wi-Fi module (144) of the gateway (140).

9. The intravenous catheter system according to any one of claims 1 to 8, wherein the hub body (156) includes a first hub body portion (166a) attached to a second hub body portion (166b).

10. The catheter system according to any one of claims 1 to 9, further comprising a fiber optic sensor (106) connected to an electronic connector assembly (280) detachably connected to a catheter hub (110).

11. The catheter system according to claim 1, wherein the sensor (106) attached to the catheter tube (152) is an optical fiber sensor extending to an electronic connector assembly (280) that is detachably connected to the catheter hub (110).

12. A method for monitoring signals collected by a catheter assembly (104), A sensor (106) is provided on a catheter hub (110) having an external and internal hub body (156), The data collected by the sensor (106) is wirelessly relayed to at least one of the smart device (120) and the cloud server (130). Displaying information related to the data collected in the report, A method for providing it.

13. The method according to claim 12, wherein the sensor (106) electrically communicates with lead wires (412) in a computing core (420) located outside the housing.

14. A catheter system (100), A catheter hub (110) including a hub body (156) having an external and internal structure, A catheter tube (152) having a lumen attached to a catheter hub (110), A sensor (106) is attached to at least one of the hub body (156) and the catheter tube (152) in order to sense the status of the catheter hub (110) or to monitor the patient's condition, A catheter system equipped with [a specific feature / feature].

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