Smart wing for vascular access catheters and cannulae

Abstract

A smart wing vascular access catheter / cannula (VAC) assembly including a winged receptacle configured to hold a VAC in a fixed position relative to tissue of a patient, where the VAC is positioned in between the winged receptacle and the tissue of the patient. The smart wing VAC assembly includes a battery, a microcontroller, a sensor is configured to sense a physical characteristic of the tissue of the patient or sense a physical characteristic of fluid flowing through the VAC, and a smart wing activation device configured to activate the battery to supply electrical power to the microcontroller in response to the smart wing VAC being released from packaging, or in response to a switch on the smart wing VAC being triggered based on relative movement between the VAC and the winged receptacle.

Description

[0001] SMART WING FOR VASCULAR ACCESS CATHETERS AND CAN NU LAE

[0002] FIELD OF THE INVENTION

[0003]

[0001] The subject matter disclosed herein relates to devices, systems and methods for providing a smart wing for a VAC.

[0004] BACKGROUND OF THE INVENTION

[0005]

[0002] Administering fluids, medications and parenteral nutrition by intravenous (IV) infusion therapy is one of the most common procedures in health care today. Approximately 80% of patients admitted to hospitals receive IV therapy, and around 330 million peripheral IV sets are sold in the United States every year. Simple and effective routine treatment for dehydration, infection and diseases would not be possible without IV therapy. However, even with the advances in this lifesaving procedure over the past years, there is still no simple and effective solution in the market for a battery operated vascular access catheter or cannula device (VAC) that monitors the injection site and monitors fluid flowing through the VAC.

[0006] SUMMARY OF THE INVENTION

[0007]

[0003] A smart wing vascular access catheter / cannula (VAC) assembly including a winged receptacle configured to hold a VAC in a fixed position relative to tissue of a patient, where the VAC is positioned in between the winged receptacle and the tissue of the patient, a battery mechanically supported by the winged receptacle, a microcontroller mechanically supported by the winged receptacle, a sensor mechanically supported by the winged receptacle, where the sensor is configured to sense a physical characteristic of the tissue of the patient and produce sensed data representing the physical characteristic of tissue of the patient, or sense a physical characteristic of fluid flowing through the VAC and produce sensed data representing the physical characteristic of the fluid flowing through the VAC, and a smart wing activation device configured to activate the battery to supply electrical power to the microcontroller in response to the smart wing VAC being released from packaging, or in response to a switch on the smart wing VAC being triggered based on relative movement between the VAC and the winged receptacle.

[0008]

[0004] A method for activating a smart wing vascular access catheter / cannula (VAC) assembly including a winged receptacle configured to hold a VAC in a fixed position relative to tissue of a patient, where the VAC is positioned in between the winged receptacle and the tissue of the patient a battery mechanically supported by the winged receptacle, a microcontroller mechanically supported by the winged receptacle, and a sensor mechanically supported by the winged receptacle. The sensor is configured to sense a physical characteristic of the tissue of the patient and produce sensed data representing the physical characteristic of tissue of the patient, or sense a physical characteristic of fluid flowing through the VAC and produce sensed data representing the physical characteristic of the fluid flowing through the VAC. The method includes activating the battery to supply electrical power to the microcontroller in response to the smart wing VAC being released from packaging, or in response to a switch on the smart wing VAC being triggered based on relative movement between the VAC and the winged receptacle.

[0009] BRIEF DESCRIPTION OF THE FIGURES

[0005] FIG. 1A is a cross-sectional view of a section of skin, according to an aspect of the disclosure.

[0010]

[0006] FIG. IB is a perspective view of a VAC, according to an aspect of the disclosure.

[0011]

[0007] FIG. 2A is a perspective view of a smart wing VAC assembly, according to an aspect of the disclosure.

[0012]

[0008] FIG. 2B is a perspective view of a smart wing, according to an aspect of the disclosure.

[0013]

[0009] FIG. 2C are perspective views of a smart wing VAC assembly, according to an aspect of the disclosure.

[0014]

[0010] FIG. 2D are perspective views of a smart wing VAC assembly, according to an aspect of the disclosure.

[0015] [Oil] FIG. 2E is a perspective view of a smart wing, according to an aspect of the disclosure.

[0016]

[0012] FIG. 3A is a perspective view of a smart wing VAC assembly packaged in a liner, according to an aspect of the disclosure.

[0017]

[0013] FIG. 3B is a perspective view of a smart wing, according to an aspect of the disclosure

[0018]

[0014] FIG. 3C is a perspective view of a smart wing VAC assembly packaged in a liner, according to an aspect of the disclosure.

[0019]

[0015] FIG. 3D are perspective views of the smart wing VAC assembly in FIG. 3C, according to an aspect of the disclosure.

[0020]

[0016] FIG. 4A are perspective views of a smart wing VAC assembly, according to an aspect of the disclosure.

[0017] FIG. 4B are perspective views of a smart wing VAC assembly, according to an aspect of the disclosure.

[0021]

[0018] FIG. 5 is schematic diagram of the smart wing VAC assembly system, according to an aspect of the disclosure.

[0022]

[0019] FIG. 6A is a flowchart showing activation and utilization of the smart wing VAC assembly system, according to an aspect of the disclosure.

[0023]

[0020] FIG. 6B is a flowchart showing activation and utilization of the smart wing VAC assembly system, according to an aspect of the disclosure.

[0024]

[0021] FIG. 6C is a flowchart showing activation and utilization of the smart wing VAC assembly system, according to an aspect of the disclosure.

[0025]

[0022] FIG. 7 is a view of a smart device executing a software application of the smart wing VAC assembly system, according to an aspect of the disclosure.

[0026]

[0023] FIG. 8 is flowchart showing the activation and use of the smart wing VAC assembly system, according to an aspect of the disclosure.

[0027] DETAILED DESCRIPTION OF THE INVENTION

[0028]

[0024] In the following detailed description, numerous specific details are set forth by way of examples in order to provide a thorough understanding of the relevant teachings. However, it should be apparent to those skilled in the art that the present teachings may be practiced without such details. In other instances, well known methods, procedures, components, and circuitry have been described at a relatively high-level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings.

[0029] INTRODUCTION

[0030]

[0025] The device, system and method described herein provide for a smart wing VAC assembly including a smart wing for holding any type of vacular catheter or cannula, such as intravenous catheters, arterial catheters, catheters / cannulae inserted into the arteriovenous (AV) fistula for haemodialysis, and so on. The smart wing VAC assembly generally includes sensors to monitor the IV insertion site and to monitor the fluid flowing through the VAC that will help clinicians and health care providers (e.g. doctors, nurses, technicians) to diagnose IV complications in both the insertion site and in the fluid flowing through the VAC. The device, system and method continuously monitors the VAC insertion site and the fluid flowing through the VAC, and may be integrated with existing patient's electronic medical records (EMR). The device, system and method also ensures that the electronic components of the smart wing VAC assembly are deactivated when not in use (e.g. when in packaging, etc.), and are activated when in use (e.g. when applied to the patient for IV treatment).

[0031]

[0026] FIG. 1A is a cross-sectional view 100 of a section of human skin including epidermis layer 102, dermis layer 104 and subcutaneous layer 106. When inserting a VAC needle into the human skin, the needle pierces epidermis 102, passes anatomical skin features of the skin layers, such as arteries 110, fat cells 112, collagen fibers 114, oil glands 116 and hair follicles 118 on its way to reaching and piercing a destination vein 108.

[0027] An example of a VAC 202 shown in Fig. IB depicts the VAC inserted into a patient's skin. This insertion could occur at various body parts (e.g. arm, hand, neck, etc.). The VAC may include catheter 124, catheter hub 122, finger push off plate 121, flashback chamber 123 and catheter needle 126. During the cannulation process, the VAC is removed from packaging and then catheter needle 126 is inserted into the skin and advanced until flashback is visible in flashback chamber 123 confirming that catheter needle 126 has pierced the destination vein. Once flashback is visible, catheter needle 126 is advanced further into the vein and the entire VAC is lowered flat onto the skin of the patient. Using push off plate 121, catheter 124 is advanced off the needle and into the vein until flashback is visible in catheter 124 confirming that catheter 124 is located in the vein. Once catheter 124 is advanced completely into the vein, the needle is withdrawn from catheter hub 122 and a septum (not visible) closes stopping the flow of blood from catheter hub 122. The VAC is then dressed to the patient. At a later time, when a luer connection is inserted into catheter hub 122, the septum is forced open allowing blood to be withdrawn or medication to be administered to the patient.

[0032]

[0028] Infiltration may occur if IV fluid or medications leak into the surrounding tissue. This may be caused by improper placement or dislodgement of the catheter. In addition, the fluid (e.g. medication) flowing through the VAC may be problematic by having the wrong concentration, bubbles, particulates causing a cloudy mixture and other unwanted physical characteristics. Occlusion (e.g. complete or partial blockage of the catheter tube) could also be a detectable problem. Occlusion may be due to the formation of a thrombus in the tube or kinking of the tube. Occlusion of the catheter tube can adversely impact the flow of liquid through the catheter into the blood vessel. This could be detected by, e.g., a flow sensor.

[0033]

[0029] In one example, in order to monitor and avoid such conditions, a smart wing VAC assembly is utilized. The smart wing VAC assembly generally includes a stabilization platform referred to herein as a smart wing to reduce dislodgement of the catheter. The smart wing includes one or more sensors that may be located between the stabilization platform and the patient's skin for monitoring the injection site, and / or may be located between the smart wing and the VAC for monitoring fluid flowing through the VAC. These sensors may include a temperature sensor, an optical sensor having an emitter and a receiver, osmolality sensor, flow sensor and the like. In one example, a temperature sensor detects the temperature change at the insertion site while the optical sensor emitter uses light, such as near infrared (NIR) light, that is absorbed and reflected by the biological tissue and any fluid present in the biological tissue. In another example, an optical sensor may detect particulates or turbidity in the fluid flowing through the VAC, while a flow rate sensor detects flow rate of the fluid flowing through the VAC, and an osmolality sensor detects concentration of the fluid flowing through the VAC.

[0034]

[0030] The smart wing VAC assembly also includes an activation mechanism (e.g. switch, pull tab, etc.) that activates (e.g. provides electrical power) to the integrated electronic components (e.g. sensors, processor, etc.) when in use. This activation mechanism is designed to ensure that the smart wing VAC is deactivated (no power is consumed) when the smart wing VAC is not in use (e.g. in its packaging, out of its packaging but before cannulation, etc.) to preserve battery life, while also being designed to ensure that the smart wing VAC is active at the time of use on a patient.

[0035] DEVICE / SYSTEM HARDWARE AND ACTIVATION

[0036]

[0031] An example of the smart wing VAC assembly is shown in Fig. 2A where smart wing 204 is mounted to (e.g. on top of) VAC 202. Smart wing 204 generally has an orifice that is slightly smaller than hub 122. Thus, the mounting may be accomplished by snapping smart wing 204 onto hub 122 or flashback chamber 123 of VAC 202. Smart wing 204 also includes electronic components including a processor, a transceiver for wirelessly transmitting / receiving data, and at least one sensor on or in communicative contact with one or more PCBs mounted to smart wing 204 for monitoring the injection site and / or fluid flowing through VAC 202. Although not shown, additional sensors may also be either glued to VAC 202, inserted directly into VAC 202, molded together with VAC 202 soldered or welded to a PCB (not shown) on VAC 202.

[0037]

[0032] An isolated close-up view of smart wing 204 is shown in Fig. 2B, where smart wing 204 includes VAC horn 204A having an orifice for accepting the VAC and stabilization wings 204B and 204C for stabilizing the VAC on the patient's skin. Stabilization wings 204B and 204C also include sensor 204G for detecting fluid flowing through the VAC, optional sensor 204H, microcontroller 204D for controlling the sensors and performing other processing tasks, battery 204E for powering the microcontroller and sensors and flexible circuit / wire 204F for electrically connecting the battery to the microcontroller, and optional switch 205 that electrically couples microcontroller 204D to battery 204E. In practice, switch 205 is mounted on the inside of horn 204A such that it is actuated when smart wing 204 is snapped onto VAC 202. This action powers the microcontroller and other electronic components such as the sensors, transceivers, etc. via battery 204E.

[0038]

[0033] As shown in Fig. 2C, sensors may also be placed in locations below wings 204B and 204C, as well as on portions of VAC 202. For example, sensors 2041 and 204J may be placed below wings 204B and 204C to monitor the patient's skin near the injection site. Likewise, sensors 204K and 204M may be placed on top of wings 204B and 204C. Sensors such as sensor 204L may also be placed on portions (e.g. hub, flashback chamber, etc.) of VAC 202 to monitor fluid flowing through of VAC 202. Although not shown, these sensors are electrically coupled to microcontroller 204D. As shown in Fig. 2D, optical sensors may be configured as transmitter / receiver pairs 207A / 207B that are positioned on opposite sides within horn 204A of smart wing 204. This allows transmitter 207A to transmit light through the flash chamber of VAC 202, which is then received by receiver 207B and processed by microcontroller 204D.

[0039]

[0034] In general, sensors can be placed at any location on smart wing 204. As shown in Fig. 2E, for example, sensors for detecting fluid flowing through VAC 202 can be placed on a side wall 210 within horn 204A or placed on the top wall 212 within horn 204A. Sensors for monitoring the injection site may be placed at positions 214 below wings 204B and 204C. sensors may also be placed on the VAC itself for performing these sensing tasks. These sensors are coupled to the microcontroller 204D which provides power to the sensors from battery 204E, and also reads data from the sensors.

[0040]

[0035] In an effort to save battery life and ensure activation for cannulation, a mechanism is desired to achieve the goals of: 1) ensuring that battery power is not be being consumed by the integrated electronics when the smart wing VAC assembly is not in use, and 2) ensuring that the integrated electronics are activated (i.e. apply electrical power from the battery to the microcontroller and sensors) when the smart wing VAC assembly is in use. Once such mechanism is the switch 205 shown in Fig. 2B that electrically connects microcontroller 204D to battery 204E when smart wing 204 is snapped onto VAC 202. Switches placed at various locations on the smart wing VAC assembly, as well as other mechanisms (e.g. pull tabs), which are described below with reference to Figs. 3A-3D, 4A and 4B may be implemented for achieving these goals.

[0041]

[0036] In a first set of examples, as shown in Figs. 3A-3D, the activation mechanism automatically activates the smart wing VAC assembly upon removal from a plastic liner. For example, as shown in Fig. 3A, the battery may be a metal-air battery such as a Zinc air battery 304 or the like that requires contact with oxygen to begin providing electrical power to the integrated electronics. During packaging, the smart wing VAC assembly may be placed in an air tight plastic liner 302 that ensures that no oxygen is present to activate Zinc air battery 304 during storage and shipment. When the clinician wishes to use the smart wing VAC assembly, they remove the smart wing VAC assembly from the liner (e.g. tear or peel open the plastic liner). Upon removal from the liner, Zinc air battery 304 becomes exposed to oxygen in the air and activates (i.e. begins supplying power to the integrated electronics). In order to ensure that Zinc air battery 304 becomes exposed to oxygen, smart wing 204 may also include air circulation channels 306A / 306B (see Fig.

[0042] 3B) and / or holes (not shown) that allow air to freely circulate throughout smart wing 204 to ensure that Zinc air battery 304 becomes exposed to adequate oxygen when in use.

[0037] In a second example, as shown in Fig. 3C, battery 304 may be a lithium ion cell (e.g. disposable or chargeable) battery or a paper battery (battery formed by combining carbon nanotubes with a conventional sheet of cellulose-based paper) that includes a plastic separator tab 308 inserted during manufacturing and / or packaging to ensure that electrical power does not flow to the integrated electronics during storage and shipment within plastic liner 302. More specifically, one end of plastic separator tab 308 isolates battery 304 from the integrated electronics, while the other end of plastic separator tab 308 is connected (e.g. glued) to release liner 302. When the clinician wishes to use the smart wing VAC assembly, they remove the smart wing VAC assembly from the liner (e.g. tear or peel open the plastic liner). The removal of the smart wing VAC assembly from the liner 302 causes liner 302 to pull and separate tab 308 from battery 304, thereby automatically activating the smart wing VAC assembly (i.e. supplying power to the integrated electronics). Fig. 3D shows the smart wing 204 from Fig. 3C where the plastic liner 308 is inserted into slot 310 of the smart wing. Removal of the smart wing VAC assembly from the liner 302 causes liner 302 to pull and separate tab 308 from battery 304, at which point smart wing 204 becomes active. After cannulation, smart wing 204 is then snapped onto VAC 202 for monitoring VAC 202 and the injection site.

[0043]

[0038] The examples shown in Figs. 3A-3D provide a liner based activation mechanism such that the healthcare worker does not have to take an extra step to activate the smart wing VAC assembly (that could be forgotten) after removing the VAC from the package. For example, the healthcare worker does not have pull the tab after removing the smart wing VAC assembly from the liner. The smart wing VAC assembly is automatically activated (e.g. battery is automatically activated or tab is automatically pulled) when removed from the liner (e.g. the wrapper).

[0044]

[0039] Other automatic activation methods / device are also possible for the electronics of the smart wing VAC assembly after the smart wing VAC assembly is removed from the liner. Specifically, a tab, such as tab 308, may be manually pulled from the assembly. As another example, or a switch may be triggered (or a tab may be removed) by actions taken during the cannulation process. The cannulation process may include, for example, removing a protective cap and then inserting catheter needle 126 into the skin until flashback is visible in flashback chamber 123 confirming that catheter needle 126 has pierced the destination vein. Once flashback is visible, catheter needle 126 is advanced further into the vein and the entire VAC is lowered flat onto the skin of the patient. Using push off plate 121, catheter 124 is advanced off the needle and into the vein until flashback is visible in catheter 124 confirming that catheter 124 is located in the vein. Once catheter 124 is advanced completely into the vein, the needle is withdrawn from catheter hub 122 and guarded by a safety clip. The septum (not visible) also closes stopping the flow of blood from catheter hub 122. At any point, a user action to perform the cannulation process may be used to trigger a switch or otherwise connect power.

[0045]

[0040] For example, FIG. 4A shows how a switch may be activated during the cannulation process. View (i) shows the VAC 202 prior to the cannulation process, in which the VAC 200 is attached to a protective cover 402 and a needle housing 404. The protective cover 402 includes a tab 406 that blocks a gap between a deformable conductive spring clip 408 and the bottom side of the VAC 202. When the protective cover 402 is removed, the tab 406 is removed from the gap, and the gap can now be closed to make electrical contact between the spring clip 408 and the remainder of the electrical circuit to activate the battery. For example, the spring clip 408 may be pressed into contact to activate the battery when the VAC is secured to the patient by a dressing, due to the dressing pulling the VAC 202 against the skin and flexing the parts. As another example, the user may manually compress the spring clip 408 against the remainder of the electrical circuit to activate the battery. In still another example, the spring clip 408 may be biased towards the remainder of the electrical circuit via spring tension such that the spring clip 408 automatically moves into contact to activate the battery when the tab 406 is removed.

[0046]

[0041] View (ii) of FIG. 4A shows an arrangement similar to that of view (i) but in this case the tab 406 is mounted to the needle housing 404. View (iii) shows another similar arrangement, in which the tab 406 is mounted to a safety clip 410 that is removed when the needle 412 is retracted. Other alternatives and embodiments will be apparent to persons of ordinary skill in the art in view of the present disclosure.

[0047]

[0042] Rather than a pull tab as described above, the smart wing VAC assembly may implement a switch to activate the electronic devices. In one example, smart wing 204 may include switch 408 (e.g. tactile spring loaded switch) mounted in the orifice of horn 204A. Prior to activation, switch 408 normally protrudes (e.g. due to spring force) from the orifice. Switch 408 is a normally open switch when protruding from the surface, thereby electrically isolating battery 204E from the integrated electronics 204D. In order to activate the electronics, the clinician inserts VAC 202 into the orifice of horn 204A. This action snaps VAC 202 into the orifice which contacts and depresses switch 408 (i.e. the force of VAC 202 depresses switch 404) and holds it closed, thereby supplying power from battery 204E to the integrated electronics 204D.

[0048]

[0043] It is also noted that the power switch 408 can be an electronic pressure switch rather than a spring loaded switch. For example, power switch 408 can be a pressure sensor that has a resistance or capacitance that varies with applied force. If no force is applied to the switch (e.g. VAC 202 is not snapped into horn 204A), power switch 408 prevents flow of electricity from the battery. If, however, an appropriate amount of force is applied (e.g. VAC 202 is snapped into horn 204A), power switch 408 allows flow of electricity from the battery to activate the device. Although not shown in Figs. 2A-4B, the smart wing 204 can also be mounted directly to the infusion line (not shown) to monitor flow of fluids (e.g. medications) being introduced into the catheter.

[0049] OVERALL SYSTEM AND DATA PROCESSING

[0050]

[0044] As shown in FIG. 5, in addition to the smart wing VAC assembly, the overall smart VAC system 500 may also include a wireless access point (e.g. WiFi, Bluetooth, BLE, etc.), a smart device 506 (e.g. smartphone, tablet, laptop, PDA, etc.) and a medical server 508 that work together to monitor the patient's VAC injection site, output alerts and record results.

[0051]

[0045] In this configuration, integrated electronics 502 may include processor 502A, battery 502B, optical sensor 502C to detect characteristics of the injection site or of the fluid flowing through the VAC, bubble sensor 502D to detect bubbles in the fluid flowing through the VAC, analog-to-digital converter (ADC) 502E to convert analog signals from the sensors to digital signals for processing by 502A, switch 502F to activate / deactivate the smart wing VAC assembly, LED 502G as an indicator light, buzzer 502H as an output device and transceiver 5021 to communicate with access point 504 and / or smart device 506. It is noted that transceiver 5021 could be wireless (e.g. WiFi, Bluetooth, BLE, Cellular or the like) or wired (USB, Micro-USB or the like) to communicate with smart device 506 and / or access point 504. It is also noted that wireless access point 504 and smart device 506 could use various wireless protocols (e.g. WiFi, Bluetooth, BLE, Cellular, or the like). During operation, transceiver 5021 could communicate directly with smart device 506 or indirectly with smart device 506 via wireless access point 504. Although not shown, other sensors, such as a flow rate sensor, a particulate or turbidity sensor, or an osmolality sensor may be included and connected to the ADC 502E.

[0052]

[0046] In one example, all of these integrated electronics devices may be on the same printed circuit board (PCB) that is integrated in either the smart wing or the VAC. In another example, these integrated electronics devices may be on different PCBs integrated in either the smart wing or the VAC. For example, devices 502A-502E may be on a main PCB, whereas devices 502F-502H may be on a separate PCB. These separate PCBs may be electrically connected, for example, via a cable (e.g. flexible circuit cable).

[0053]

[0047] Once integrated electronics 502 are activated by switch 502F (e.g. as a result of VAC 202 being snapped into horn 204A) and the catheter is inserted into the patient, processor 502A illuminates LED 502G to show that assembly is activated, and sensors 502C and 502D begin monitoring the insertion site and the fluid flowing through the VAC. Processor 502A executes a program in the memory to receive digital data via ADC 502E from the sensors and process the sensor data. The processed sensor data indicates characteristics of the injection site and the fluid flowing through the VAC. If the characteristics (e.g. temperature) of the injection site or characteristics of the fluid flowing through the VAC are abnormal, processor 502A may control LED 502G to change color / blink, or control buzzer 502H to buzz indicating an abnormality directly to the patient and clinician.

[0054]

[0048] In addition, processor 502A also executes a program in the memory to control transceiver 5021 to connect wirelessly with either access point 504 or smart device 506. This allows processor 502A to wireless transmit the sensor data, warnings and the like to smart device 506. For example, processor 502A may send raw sensor data or processed sensor data to smart device 506. Processing of the raw data may be performed by processor 502A of the smart wing VAC assembly, by a processor (not shown) of smart device 506 or by a combination of both processors. In either case, the sensor data is processed and the results are displayed to via smart device 506. The sensor data may include temperature information, optical properties of the insertion site and characteristics of fluid flowing through the VAC. In addition, other data and alerts may be computed based on the sensor data and displayed (e.g. alerts of detected infiltration, occlusion, alerts of temperature differences, alerts for flow rate, etc.).

[0055]

[0049] This information may also be transmitted from smart device 506 to server 508 for processing and / or for storage of medical records. In general, VAC assembly electronics 502, smart device 506 and server 508 work in conjunction to monitor the sensors of VAC assembly electronics 502, process the VAC sensor data, make determinations regarding the status of the injection site and status of the fluid flowing through the VAC, and provide feedback to the patient and / or to the clinician.

[0050] FIG. 6A is a flowchart showing activation and utilization of the smart wing VAC assembly system in Figs. 3A and 3B. In step 602 the clinician removes the smart wing VAC assembly from the package, whereby the release liner is automatically removed and the battery is activated. The clinician performs IV cannulation in step 604 and the smart wing VAC assembly monitors the sensors and then wirelessly transmits, in step 606, feedback data (e.g. sensor data, processed sensor data, warnings, etc.) to the clinician. Alternatively, or additionally, feedback may also be provided directly via indicator lights and buzzers on the VAC assembly system.

[0056]

[0051] FIG. 6B is a flowchart showing activation and utilization of the smart wing VAC assembly system in Figs. 3C, 3D and 4A. In step 612 the clinician removes the smart wing VAC assembly from the package. If a plastic pull tab is connected to the package (e.g. the liner) as shown in Figs. 3C and 3D, the plastic pull tab is removed and the battery is activated. The clinician then performs IV cannulation in step 614. If a plastic pull tab, however, is connected between movable portions of the assembly as shown in Fig. 4A, the plastic tab is removed during the cannulation process and the battery is activated. In either case, during step 616, the smart wing VAC assembly monitors the sensors, and then wirelessly transmits the feedback data (e.g. sensor data, processed sensor data, warnings, etc.) to the clinician. Alternatively, or additionally, feedback may also be provided directly via indicator lights and buzzers on the VAC assembly system.

[0057]

[0052] FIG. 6C is a flowchart showing activation and utilization of the smart wing VAC assembly system in Fig. 4B. In step 622 the clinician removes the smart wing VAC assembly from the package. The clinician snaps the VAC 202 into the horn of smart wing 204 in step 624 which triggers the switch 408 to activate the battery as shown in Fig. 4B. The clinician then performs IV cannulation in step 626. The smart wing VAC assembly then monitors the sensors, and then wirelessly transmits, in step 628, the feedback data (e.g. sensor data, processed sensor data, warnings, etc.) to the clinician. Alternatively, or additionally, feedback may also be provided directly via indicator lights and buzzers on the VAC assembly system.

[0058] SOFTWARE APPLICATION AND OPERATIONAL FLOW

[0059]

[0053] FIG. 7 shows an example of the software application executed on the clinician's smart device 506. In this example, smart device 506 displays sensor data 702, patient data 704 and control buttons 706-710.

[0060]

[0054] In one example, sensor data 702 may indicate the quality of the skin at the insertion site as determined by the optical sensor and / or temperature of the skin as determined by the temperature sensor. If this displayed data, for example, exceeds a threshold, then an alert "COMPLICATION" is displayed to alert the caregiver of the situation. For example, in the case of the optical data, the threshold may be: 1) a predetermined threshold of reflected light intensity at specific frequencies that correlate with the presence of infiltration, occlusion, or 2) a comparison between the reflected light intensity at specific frequencies over time. In the case of the temperature data, the threshold may be: 1) a predetermined threshold of temperature at specific frequencies that correlate with the presence of infiltration, occlusion, 2) a comparison between the temperature over time, or 3) a comparison of insertion site temperature with body temperature captured by two or more sensors, such as temperature sensors that are close together near the insertion site, or between a sensor near the insertion site and a remote sensor located on a different part of the same limb or elsewhere on the body (e.g., the torso).

[0061]

[0055] In another example, sensor data 702 may indicate the fluid flowing through the VAC. If this displayed data, for example, indicates that the fluid rate is too high, the concentration of fluid is too high, or that certain particulates are detected in the fluid, then an alert "WARNING" is displayed to alert the caregiver of the situation.

[0062]

[0056] Patient data 704 may include, among others, patient ID, patient age / weight, catheter insertion time and catheter replacement time. Control buttons 706-710 may, among others, allow the caregiver to switch between sensor readings (e.g. temperature and optical properties), access / modify patient information, and navigate to the home screen of the application.

[0063]

[0057] FIG. 8 is flowchart 800 showing the operation of the smart catheter system. In step 802 the patient is admitted to the hospital to receive infusion treatment. In step 804, the patient is registered and then warded in step 806. In step 808, the caregiver (nurse tending to the patient) opens the mobile application on smart device 506. In step 810, the mobile application wirelessly connects to server 508 and sends the patient information (e.g. patient ID) to server 508. Server 508 may then transmit patient medication information to smart device 506. In step 812, the caregiver then activates the smart wing VAC assembly and performs cannulation. In step 814, the sensor module of smart wing VAC assembly then begins monitoring the optical properties and / or temperature of the insertion site, as well as properties of the fluid flowing through the VAC, and connects wirelessly to smart device 506 or to wireless access point 504. In step 816, the monitored data is then analyzed and displayed to the clinician via smart device 506. The data as well as any alerts may be forwarded by smart device 506 to medical server 508 for storage in the patient's medical records. Alternatively, or additionally, feedback may also be provided directly via indicator lights and buzzers on the smart wing VAC assembly system.

[0064] CONCLUSION

[0065]

[0058] The steps in FIGS. 6-8 may be performed by the sensor module, the smart device, the server, or a combination thereof upon loading and executing software code or instructions which are tangibly stored on a tangible computer readable medium, such as on a magnetic medium, e.g., a computer hard drive, an optical medium, e.g., an optical disc, solid-state memory, e.g., flash memory, or other storage media known in the art. In one example, data are encrypted when written to memory, which is beneficial for use in any setting where privacy concerns such as protected health information is concerned. Any of the functionality performed by the computer described herein, such as the steps in FIGS. 6-8 may be implemented in software code or instructions which are tangibly stored on a tangible computer readable medium. Upon loading and executing such software code or instructions by the computer, the controller may perform any of the functionality of the computer described herein, including the steps in FIGS. 6-8 described herein.

[0066]

[0059] It will be understood that the terms and expressions used herein have the ordinary meaning as is accorded to such terms and expressions with respect to their corresponding respective areas of inquiry and study except where specific meanings have otherwise been set forth herein. Relational terms such as first and second and the like may be used solely to distinguish one entity or action from another without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms "comprises," "comprising," "includes," "including," or any other variation thereof, are intended to cover a nonexclusive inclusion, such that a process, method, article, or apparatus that comprises or includes a list of elements or steps does not include only those elements or steps but may include other elements or steps not expressly listed or inherent to such process, method, article, or apparatus. An element preceded by "a" or "an" does not, without further constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises the element.

[0067]

[0060] Unless otherwise stated, any and all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. Such amounts are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain. For example, unless expressly stated otherwise, a parameter value or the like may vary by as much as ± 10% from the stated amount.

[0068]

[0061] In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various examples for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed examples require more features than are expressly recited in each claim. Rather, as the following claims reflect, the subject matter to be protected lies in less than all features of any single disclosed example. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

[0062] While the foregoing has described what are considered to be the best mode and other examples, it is understood that various modifications may be made therein and that the subject matter disclosed herein may be implemented in various forms and examples, and that they may be applied in numerous applications, only some of which have been described herein. It is intended by the following claims to claim any and all modifications and variations that fall within the true scope of the present concepts.

Claims

CLAIMS1. A smart wing vascular access catheter / cannula (VAC) assembly including: a winged receptacle configured to hold a VAC in a fixed position relative to tissue of a patient, the VAC being positioned in between the winged receptacle and the tissue of the patient; a battery mechanically supported by the winged receptacle; a microcontroller mechanically supported by the winged receptacle; a sensor mechanically supported by the winged receptacle, the sensor configured to sense a physical characteristic of the tissue of the patient and produce sensed data representing the physical characteristic of tissue of the patient, or sense a physical characteristic of fluid flowing through the VAC and produce sensed data representing the physical characteristic of the fluid flowing through the VAC; and a smart wing activation device configured to activate the battery to supply electrical power to the microcontroller in response to: the smart wing VAC being released from packaging, or a switch on the smart wing VAC being triggered based on relative movement between the VAC and the winged receptacle.

2. The smart wing VAC assembly of claim 1, further comprising: a transceiver mechanically supported by the winged receptacle, the transceiver configured to transmit the sensed data to a smart device remote from the winged receptacle.

3. The smart wing VAC assembly of claim 1, wherein the at least one sensor includes at least one of a temperature sensor, a NIR emitter, a photodiode, a pressure sensor, a biosensor, or an optical flow sensor for sensing the physical characteristic of the tissue of the patient or the physical characteristic of the fluid flowing through the VAC.

4. The smart wing VAC assembly of claim 1, wherein the sensor is mounted to a portion of the winged receptacle between the VAC and the tissue of the patient to position the sensor against the tissue of the patient, or wherein the sensor is mounted to a portion of the winged receptacle adjacent to the VAC to position the sensor against the VAC.

5. The smart wing VAC assembly of claim 1, further comprising: an indicator device mechanically supported by the winged receptacle, the indicator device configured to output information based on the sensed data.

6. The smart wing VAC assembly of claim 1, wherein the battery is at least one of a metal-air battery that is activated by exposure to air in response to the smart wing VAC being released from packaging, or a paper battery that is activated in response to the smart wing VAC being released from the packaging.

7. The smart wing VAC assembly of claim 1, further comprising: a pull tab electrically insulating the battery from the microcontroller, the pull tab physically connected to the packaging,wherein the pull tab is removed and the battery is activated in response to the packaging pulling the tab when the smart wing VAC is released from packaging.

8. The smart wing VAC assembly of claim 1, a plastic separator electrically insulating the battery from the microcontroller, wherein the plastic separator is displaced, and the battery is activated in response to a physical separation of VAC components.

9. The smart wing VAC assembly of claim 1, wherein the sensor is mounted to a portion of the winged receptacle to position the sensor against a fluid chamber of the VAC.

10. The smart wing VAC assembly of claim 1, wherein the relative movement between the VAC and the winged receptacle is in response to the VAC being mounted to the winged receptacle.

11. A method for activating a smart wing vascular access catheter / cannula (VAC) assembly including a winged receptacle configured to hold a VAC in a fixed position relative to tissue of a patient, the VAC being positioned in between the winged receptacle and the tissue of the patient a battery mechanically supported by the winged receptacle, a microcontroller mechanically supported by the winged receptacle, and a sensor mechanically supported by the winged receptacle, the sensor configured to sense a physical characteristic of the tissue of the patient and produce sensed data representing the physical characteristic of tissue of the patient, or sense a physical characteristic of fluid flowing through the VAC and produce sensed data representingthe physical characteristic of the fluid flowing through the VAC, the method including: activating the battery to supply electrical power to the microcontroller in response to: the smart wing VAC being released from packaging, or a switch on the smart wing VAC being triggered based on relative movement between the VAC and the winged receptacle.

12. The method for activating a smart wing VAC assembly of claim 11, further comprising: transmitting, by a transceiver mechanically supported by the winged receptacle, the sensed data to a smart device remote from the winged receptacle.

13. The method for activating a smart wing VAC assembly of claim 11, wherein the at least one sensor includes at least one of a temperature sensor, a NIR emitter, a photodiode, a pressure sensor, a biosensor, or an optical flow sensor for sensing the physical characteristic of the tissue of the patient or the physical characteristic of fluid flowing through the VAC.

14. The method for activating a smart wing VAC assembly of claim 11, wherein the sensor is mounted to a portion of the winged receptacle between the VAC and the tissue of the patient to position the sensor against the tissue of the patient, or wherein the sensor is mounted to a portion of the winged receptacle adjacent to the VAC to position the sensor against the VAC.

15. The method for activating a smart wing VAC assembly of claim 11, further comprising: outputting, by an indicator device mechanically supported by the winged receptacle, information based on the sensed data.

16. The method for activating a smart wing VAC assembly of claim 11, further comprising: activating the battery by exposure to air in response to the smart wing VAC being released from packaging.

17. The method for activating a smart wing VAC assembly of claim 11, further comprising: activating the battery in response to the packaging pulling a pull tab electrically insulating the battery from the microcontroller.

18. The method for activating a smart wing VAC assembly of claim 11, further comprising: activating the battery in response to displacing a plastic separator electrically insulating the battery from the microcontroller, in response to a physical separation of VAC components.

19. The method for activating a smart wing VAC assembly of claim 18, further comprising: wherein the sensor is mounted to a portion of the winged receptacle to position the sensor against a fluid chamber of the VAC.

20. The method for activating a smart wing VAC assembly of claim 11, activating the battery in response to the VAC being mounted to the winged receptacle.

Images