Smart Intravenous Catheter System

Abstract

The smart intravenous catheter (IVC) assembly (201) includes a stabilization platform (202) configured to hold the IVC (212) in a defined position relative to a patient's tissue, and a sensor module (204) mechanically supported on the stabilization platform (202). The sensor module (204) includes at least one sensor configured to detect a physical characteristic of the patient's tissue and generate detected data representative of the physical characteristic of the patient's tissue, and a transceiver (502H) configured to transmit the detected data from the stabilization platform (202) to a remote smart device (506).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority from U.S. Provisional Application No. 63 / 211,677, filed June 17, 2021, the contents of which are incorporated herein by reference in their entirety for all purposes. [Technical field]

[0002] The subject matter disclosed herein relates to devices, systems, and methods for providing a smart intravenous catheter system. [Background technology]

[0003] Administration of fluids, medications, and parenteral nutrition through intravenous (IV) infusion therapy is one of the most common procedures in healthcare today. Approximately 80% of hospitalized patients receive IV therapy, and approximately 330 million peripheral IV sets are sold annually in the United States. IV therapy is essential for simple and effective routine medical treatment of dehydration, infection, and illness. However, despite advances in this life-saving procedure over the past few years, there is still no simple solution on the market that can continuously monitor and automatically detect when peripheral IV infusions begin to leak, causing medications and fluids intended for IV administration to leak into the subcutaneous tissue and accumulate. When infusions occur, damage to the patient can range from pain and redness to nerve / tissue damage and amputation of the limb. The frequency of IV infusions is alarming. Besides IV infusions, other complications such as phlebitis and CRBSI (catheter-related bloodstream infection) are also problematic. Phlebitis, associated with inflammation of the veins, is the second most common IV complication. CRBSI caused by the presence of bacteremia due to intravenous catheters (IVC) is one of the most serious complications that can lead infected patients to surgical intervention and even death. Therefore, it is important to detect IV complications as early as possible before they become catastrophic. Summary of the Invention

[0004] The smart intravenous catheter (IVC) assembly includes a stabilization platform configured to hold the IVC in a defined position relative to a patient's tissue, and a sensor module mechanically supported by the stabilization platform, the sensor module including at least one sensor and a transceiver, the sensor configured to detect a physical characteristic of the patient's tissue and generate sensed data representative of the physical characteristic of the patient's tissue, and the transceiver configured to transmit the sensed data from the stabilization platform to a remote smart device.

[0005] A smart intravenous catheter (IVC) method includes detecting a physical characteristic of a patient's tissue with a sensor of a sensor module attached to a stabilization platform that holds the IVC in a defined position relative to the patient's tissue, generating detected data representative of the physical characteristic of the patient's tissue with the sensor of the sensor module, transmitting the detected data from the stabilization platform to a remote smart device with a transceiver of the sensor module, and outputting output data related to the detected data by the smart device to a patient or a healthcare provider.

[0006] The smart intravenous catheter (IVC) assembly includes a central processor and a sensor module, the sensor module including a first temperature sensor configured to measure a body temperature at a patient's IVC insertion site to generate first temperature data, and a first transceiver configured to transmit the first temperature data to the central processor. A second temperature sensor is configured to measure a body temperature at a reference site on the patient remote from the IVC insertion site to generate second temperature data. The second transceiver is configured to transmit the second temperature data to the central processor. The central processor is configured to compare the first temperature data with the second temperature data to determine a temperature difference and generate a signal when the temperature difference reaches a predetermined threshold. [Brief description of the drawings]

[0007] [Figure 1A]1 illustrates a cross-sectional view of a portion of skin according to one embodiment of the present disclosure. [Figure 1B] FIG. 1 is a perspective view of a venous catheter according to one aspect of the present disclosure. [Figure 2A] FIG. 1 is a perspective view of a smart intravenous catheter connected to a leader band, according to one aspect of the present disclosure. [Figure 2B] FIG. 2B is a perspective view of a sensor module for the smart venous catheter of FIG. 2A according to one embodiment of the disclosure. [Figure 2C] FIG. 2C is a perspective view of the sensor module of FIG. 2B illustrating an example of light reflection from a portion of human skin according to one embodiment of the present disclosure. [Figure 2D] FIG. 2B is a side view of the smart venous catheter of FIG. 2A with the venous catheter inserted into a patient, according to one embodiment of the present disclosure. [Figure 2E] FIG. 1 illustrates a perspective view of a smart intravenous catheter assembly with a remotely located NIR emitter and connected to a sensor module via a cable, according to one embodiment of the present disclosure. [Figure 2F] FIG. 2F is a side view of the smart venous catheter assembly of FIG. 2E with the venous catheter inserted into a patient, according to one embodiment of the present disclosure. [Figure 2G] FIG. 2B is a cross-sectional view of the smart venous catheter assembly of FIG. 2A with a gap for holding a sensor module according to one embodiment of the present disclosure. [Figure 2H] FIG. 2 is a perspective view of a sensor module including multiple temperature sensors according to one aspect of the disclosure. [Figure 3A] 1A-1D are three perspective views of a smart intravenous catheter assembly with stabilization wings, according to one embodiment of the present disclosure. [Figure 3B] FIG. 1 is a perspective view of a smart intravenous catheter assembly with stabilization wings and an internal sensor module according to one aspect of the present disclosure. [Figure 4] 3C shows two perspective views of the sensor module of FIG. 3B according to one embodiment of the present disclosure. [Diagram 5] FIG. 1 is a diagram of a smart venous catheter system according to one aspect of the present disclosure. [Figure 6]1 is a flow chart illustrating data collection and processing of a smart venous catheter system according to one aspect of the present disclosure. [Figure 7] FIG. 1 is a diagram of a smart device executing a software application for the smart venous catheter system, according to one aspect of the disclosure. [Figure 8] 1 is a flow chart illustrating the operation of a smart venous catheter system according to one aspect of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] In the following detailed description, numerous specific details are set forth by way of example in order to provide a thorough understanding of the relevant teachings. However, it will be apparent to one of ordinary skill in the art that the present teachings may be practiced without such details. In other instances, well-known methods, procedures, components, and circuits have been described at a relatively high level, without detail, in order to avoid unnecessarily obscuring aspects of the present teachings.

[0009] Introduction The devices, systems, and methods disclosed herein are provided to detect intravenous catheter (IVC) complications such as phlebitis, infiltration, CRBSI, etc., at an early stage. The devices, systems, and methods help clinicians and healthcare providers (e.g., doctors, nurses, technicians) to diagnose venous complications as early as possible before they worsen. The devices, systems, and methods continuously monitor the IVC insertion site and can be integrated with existing patient electronic medical records (EMRs). The devices, systems, and methods also help secure the catheter and prevent IVC dislodgement or kinking.

[0010] 1A is a cross-sectional view 100 of a portion of human skin including an epidermal layer 102, a dermal layer 104, and a subcutaneous layer 106. When the needle of the IVC is inserted into the human skin, it penetrates the epidermis 102, passes through anatomical features of the skin layers such as arteries 110, fat cells 112, collagen fibers 114, oil glands 116, hair follicles 118, etc., and perforates the vein 108 of interest.

[0011] The example IVC shown in FIG. 1B shows an IVC inserted into a patient's skin. This insertion can occur at various locations on the body (e.g., arm, hand, neck, etc.). The IVC can include a catheter 124, a catheter hub 122, a finger pusher plate 121, a flashback chamber 123, and a catheter needle 126. During the procedure, the catheter needle 126 is inserted and advanced into the skin until a flashback is visible in the flashback chamber 123, confirming that the catheter needle 126 has pierced the desired vein. Once a flashback is visible, the catheter needle 126 is advanced further into the vein and the entire IVC is lowered and laid flat on the patient's skin. Using the pusher plate 121, the catheter 124 is advanced out of the needle and into the vein until a flashback is visible in the catheter 124, confirming that the catheter 124 is located in the vein. Once the catheter 124 is fully advanced into the vein, the needle is withdrawn from the catheter hub 122 and a septum (not shown) closes, stopping the flow of blood from the catheter hub 122. When a Luer connection is inserted into the catheter hub 122, the septum is forced open, allowing blood to be withdrawn or medication to be administered to the patient.

[0012] However, as mentioned above, wetting can occur when IV fluids or medications leak into the surrounding tissue. This can occur due to improper placement or removal of the catheter. In one example, a smart IVC assembly is utilized to prevent or monitor for such a condition. The smart IVC assembly includes a stabilization platform (e.g., made of a soft material) to reduce catheter removal, and a sensor module disposed between the stabilization platform and the patient's skin. The sensor module can include a temperature sensor and an optical sensor having an emitter and a receiver. The temperature sensor detects temperature changes at the insertion site, while the emitter of the optical sensor uses light, such as near-infrared (NIR) light, that is absorbed and reflected by biological tissue and any fluids present therein. A spectrum associated with NIR can be transmitted through tissue, and changes in the reflected energy are captured by the receiver of the sensor and processed to determine whether the area around the IVC site is healthy or wet. In one example, the NIR emitter emits NIR into the skin tissue, and a photodetector collects the received light signal. As IV fluid wets the interstitial space, it changes the optical density of the tissue, resulting in a change in the collected optical signal. The difference in the measured signal is an indication of the presence of wetting fluid in the subcutaneous layer.

[0013] Device / System Hardware An example of a smart IVC assembly is shown in FIG. 2A, where a smart IVC catheter assembly 201 is connected (wired or wirelessly) to a reader band 206. More specifically, the smart IVC catheter assembly 201 includes an IVC 212, a stabilization platform 202, and a sensor module 204. In this example, the stabilization platform 202 includes a base portion 202A, a ramp portion 202B, and a catheter mount 202C, as well as a slot (not shown) for holding the sensor module 204 in place. The stabilization platform 202 may be manufactured from a material (e.g., plastic, rubber, etc.) that is sufficiently sturdy to hold the IVC 212 in place while providing comfortable and hygienic conditions for the patient. The IVC 212 may be any type of catheter that is mechanically supported by the stabilization platform 202. For example, the IVC 212 is slid or snapped into the catheter mount 202C (e.g., a sleeve opening).

[0014] In fact, when a patient is admitted to the hospital, the patient is provided with a reader band 206. During registration, the patient is assigned a patient ID and information regarding the patient's medication and treatment is collected. Once the patient is admitted to the room, a nurse registers the patient using a mobile application (not shown) via a mobile device (not shown), and the patient's information is visible in the application. The nurse then performs an IVC procedure on the patient, performs the intubation procedure as usual using the catheter stabilization platform in which the sensing module is inserted, and places a dressing on the smart IVC assembly to fix both the IVC and the sensor module. In fact, the catheter insertion may be performed before or after attaching the IVC 212 to the stabilization platform 202. Once the catheter is inserted, the base portion 202A of the stabilization platform 202 rests on the patient's skin (e.g., arm, hand, etc.) and a dressing may be placed on the base portion 202A to avoid unwanted movement. The stabilization platform 202 holds the IVC 212 at a proper angle to avoid kinking or dislodging the catheter.

[0015] A connection is then established between the sensor module and the reader band (e.g., wirelessly via wireless connection 208A or wired via physical wire 208B). Although not shown, the reader band also wirelessly connects to the nurse's mobile device. A wireless connection such as connection 208A may be Wi-fi, Bluetooth, radio frequency identification (RFID), or any other equivalent wireless protocol. Once the connection is complete, the nurse begins to monitor early clinical signs and symptoms at the injection site through a mobile application on the mobile device. The patient can also receive audio and visual notifications directly from the reader band. These notifications may indicate signs and symptoms of complications at the injection site.

[0016] The sensor module 204 is shown in more detail in FIG. 2B and includes a NIR light source 212, a NIR light detector 213, a temperature sensor 214, a battery 219, support electronics 215, and a processor 217 mounted on a printed circuit board 216. Note that the battery 219 (e.g., lithium ion) may be a rechargeable battery or a thin battery also referred to as a microbattery (e.g., 0.5 mm×3.6 mm×5.6 mm, 45 mAh), and such batteries may be replaceable and designed to last the operational life of the sensor module 204. The battery 219 is mounted on the sensor module in a configuration where the sensor module is wireless. In a configuration where the sensor module is wired, power may be provided directly from the reader band via a cable.

[0017] In this example, the sensor module 204 has a width of 10 mm and a length of 20 mm. Note that the dimensions of the sensor module 204 may vary depending on the dimensions of the stabilization platform 202 and on-board electronics. For example, the dimensions of the sensor module 204 may be designed to fit into a mounting slot on the underside of the stabilization platform 202. Note that the entire sensor module is sealed and may be sterilized (e.g., washed with alcohol) for later reuse on another patient.

[0018] In operation, as shown in FIG. 2C, the sensor module 204 is used to monitor the presence of wetting fluid in the patient's skin. For example, in FIG. (A), the sensor module 204 emits light (e.g., NIR light) 216 toward the patient's skin located under the stabilizing platform 202. The light 226 is then absorbed / reflected differently depending on the presence or absence of wetting fluid. The reflected light 224 is then detected by an NIR receiver (e.g., a photodiode) and processed by the processor 214 (e.g., to determine the presence or absence of wetting fluid). Another schematic diagram of this process is shown in FIG. (B), where an NIR source 228 penetrates the skin tissue 102 and interacts with molecules of the infusion fluid 232. The infrared radiation 224 reflected by the molecules is detected by the NIR detector 230 and processed by the processor 214. Although not shown, the sensor module may include a biosensor that detects specific molecules in a biological sample of the patient. For example, a biosensor may include a probe that contacts a patient's blood to determine the presence of molecules that are indicative of moisture or other medical problems.

[0019] 2D shows an example of a smart IVC assembly 240 being inserted and monitoring an insertion site of a patient. In this example, a catheter of the smart IVC assembly 242 is inserted into a patient's vein 108 and a stabilization platform of the smart IVC assembly 242 is secured to the patient's arm. During monitoring, the optical sensor 241 of the sensor module, the temperature sensor 243 of the sensor module, and the temperature sensor 245 of the reader band monitor the patient's skin. The sensor module analyzes the reflected light from the skin 102 to detect the presence or absence of infiltrating fluid 246. The temperature of the insertion site measured by the temperature sensor 243 is compared to the patient's body temperature detected by the temperature sensor 245 to determine if the temperature of the injection site is above or below the body temperature, which may indicate a complication at the injection site.

[0020] For example, if a nurse receives a notification from the mobile application that there is an average temperature increase (e.g., 2°C) detected by the sensor module, the patient may be diagnosed with phlebitis. If there is a change in the optical properties of the tissue due to fluid leakage, the patient may be diagnosed with infiltration / extravasation. According to one study, a temperature drop of less than 0.7°C / cm is the optimal cutoff to assess a patient as having extravasation. If the body temperature monitored through the mobile application exceeds 38.3°C, the critically ill patient needs to be evaluated for infection and may be diagnosed with CRBSI.

[0021] In another example, the smart IVC assembly 250 shown in FIG. 2E has the NIR emitter 252 physically separated from the NIR detector 254. For example, the NIR detector 254 may be located on the sensor module as described above. However, the NIR emitter 252 is extended via wires (or wirelessly) so that it can be attached to a remote location on the user's skin. This may be useful for monitoring the entire length of the catheter inserted into the patient's skin.

[0022] For example, FIG. 2F illustrates an example of a smart IVC assembly 254 being inserted and monitoring an insertion site of a patient. In this example, a catheter of the smart IVC assembly 254 is inserted into a patient's vein 108 and a stabilization platform of the smart IVC assembly 254 is secured to the patient's skin (e.g., arm). During IVC monitoring, a light emitter 252 is placed at a remote location on the user's skin away from the smart IVC assembly 254 and emits light 262 into the patient's skin. An optical sensor 253 (located on a sensor module) analyzes the reflected light 262 from the skin 102 to detect the presence or absence of wetting fluid 248. This configuration is beneficial because it allows the entire length of the catheter to be monitored from the insertion point to the distal end located within the patient's vein (e.g., NIR light traverses the length of the catheter). Any wetting fluid 248 present along this entire region is detectable due to absorption / reflection of the NIR light by the fluid.

[0023] FIG. 2G shows a cross-sectional view of the smart IVC assembly 201 shown in FIG. 2A. In this view, it is apparent that the stabilization platform 202 includes a slot 203 on the bottom surface for inserting and holding the sensor module 204 (not explicitly shown). The stabilization platform 202 may be configured to accommodate a non-contact temperature sensor by having a gap 260 to hold the sensor module 204 (when inserted into the slot 203) at a fixed distance from the user's skin. Alternatively, the stabilization platform 202 may be configured to accommodate a contact temperature sensor by not having the gap 260 such that the sensor module 204 (when inserted into the slot 203) is held directly against the user's skin. This configuration ensures that the sensor contacts the user's skin, allowing for an accurate reading of the sensor.

[0024] Although the sensor module has been described as having one temperature sensor that is compared to a temperature threshold, in other configurations the sensor module may have multiple temperature sensors to obtain temperature readings at multiple locations near the insertion site for comparison. Such configurations may include a primary temperature sensor at the insertion site and at least one proximal temperature sensor further from the insertion site. Rather than comparing the primary temperature sensor reading to a threshold, the primary temperature sensor reading is compared to a proximal temperature sensor reading to determine the presence of fluid infiltration.

[0025] 2H shows a perspective view of a sensor module 270 having a temperature sensor 272 (e.g., a primary sensor located closest to the insertion site) that measures the insertion site temperature (IST) and one or more additional temperature sensors 274, 276, 278 located at various locations near the insertion site to measure the proximal reference temperature (PRT). In this example, the PRT may be calculated as the average reading of all three additional temperature sensors.

[0026] In either case, a temperature difference ΔT is calculated between the ISR and the PRT (ΔT=IST-PRT). Under normal circumstances, ΔT should be close to zero. However, if the insertion site begins to heat up due to fluid wetting, ΔT will no longer be zero (e.g., the ISR becomes larger than the PRT). Therefore, ΔT can be compared to a non-zero threshold to determine whether fluid wetting is occurring.

[0027] Although FIG. 2A shows a smart IVC assembly having a stabilization platform 202 with a base portion and a ramp portion, the stabilization platform may take different forms. In one example, as shown in FIG. 3A, the stabilization platform may take the form of stabilization wings that hold the IVC in place. For example, as shown in FIG. (A), the stabilization platform may include stabilization wings 304A / 304B and mounting slots 308. The stabilization wings 304A / 304B may be hinged, flexible, or curved to lie flat on the user's skin. The mounting slots 308 hold the IVC 302 in place. As shown in FIG. (C), the stabilization platform includes a sensor module having an optical sensor 310 and a temperature sensor 312 mounted under the stabilization wings 304A / 304B. A cross-sectional view (B) is also shown for clarity. The optical sensor 310 and the temperature sensor 312 operate in a similar manner as described above with respect to the sensor module of FIG. 2A.

[0028] In one example, the IVC 302 of the smart IVC assembly of FIG. 3A is inserted into the patient's vein 108 and the stabilizing wings 304A / 304B are secured to the patient's skin (e.g., arm). During monitoring, the optical sensor 310 of the sensor module, the temperature sensor 312 of the sensor module, and the temperature sensor 243 of the reader band (not shown) monitor the patient's skin. The optical sensor 310 (with an integrated emitter or a remotely located emitter) emits / detects light that is then analyzed by a processor (not shown) to determine the presence or absence of infiltrating fluid. The temperature measured by the temperature sensor 312 at the insertion site is compared to the patient's body temperature detected by the temperature sensor of the band to determine if the temperature at the injection site is above or below body temperature.

[0029] Rather than separately placing the optical and temperature sensors under different stabilizing wings, the sensors may be integrated in a common sensor module 328 as shown in Figure 3B. The sensor module 328 may be located between the stabilizing wings 324A / 324B as shown in Figure 3B, or may be located under one of the wings (not shown). Also, rather than completely surrounding the IVC 320, the mounting slot / bracket 326 may only partially surround the IVC 320, clamping it in place.

[0030] The sensor module 328 may be configured to be disposable (e.g., integral with the stabilization platform) or reusable (e.g., insertable and extractable from the stabilization platform). For example, a reusable sensor module may include a sensor circuit board 408 covered by an autoclave housing having a compartment 402 and a lid 406, as shown in FIGS. 4A and 4B. The sensor circuit board 408 may be electrically connected to the pins 404 to provide access to data input / output and / or charging power. The autoclave housing and pins may be sealed in a material (e.g., glass, metal, ceramic, etc.) that is steam sterilizable and reusable. In practice, at least a portion of the autoclave housing will be transparent so that an optical sensor can monitor the patient's skin. This reusable configuration allows a healthcare provider to insert the sensor module into an IVC stabilization platform for use with a first patient. Once the IVC treatment of the first patient is complete, the healthcare provider removes the sensor module, sterilizes it, and inserts it into a new IVC stabilization platform for use with a second patient.

[0031] In either configuration, the smart IVC assembly provides an integrated solution where the sensor module and the stabilization platform are integrated together with the IVC. This avoids bulkiness of the device and provides comfort to the patient. The sensor module to be inserted at the bottom of the stabilization platform may be reusable and rechargeable (e.g., direct electrical connection charging or inductive charging). In one example, the sensor module is covered (e.g., with a clear plastic case) to allow disinfection using alcohol, and this waterproof coating ensures that the electronics are impermeable to water. In another example, the sensor module is sealed in a material (e.g., glass, metal, ceramic, etc.) that is steam sterilizable and reusable.

[0032] Overall system and data processing As shown in FIG. 5, in addition to the smart IVC assembly 501 and the reader band 504, the overall smart IVC system 500 includes a smart device 506 (e.g., a smartphone, tablet, laptop, etc.) and a medical server 508, which cooperate to monitor the patient's IVC injection site, output warnings, and record results. For example, when the smart IVC assembly 502 is inserted into the slot of the stabilization platform and activated (e.g., by a switch or button, not shown), and the catheter is inserted into the patient, the sensor module 502 starts monitoring the insertion site. Specifically, the processor 502E executes a program in the memory, controls the transceiver 502H to wirelessly connect with the reader band 504, controls the NIR emitter 502A to start emitting NIR light, controls the NIR receiver 502B to start detecting NIR light, and controls the temperature sensor 502C to start monitoring the temperature of the insertion site. Control of the NIR emitter 502A, temperature sensor 502C, and photodiode 502B is performed through an analog-to-digital converter (ADC) 502G. The various devices / components within the sensor module 502 are powered by a power source 502F (e.g., a rechargeable battery or a replaceable microbattery).

[0033] The monitored light and temperature data are then transmitted (e.g., wirelessly) to the reader band 504. Specifically, the processor 502E may transmit raw or processed sensor data to the reader band 504. The sensor data may then be transferred from the reader band 504 to the smartphone 506. The processing of the raw data may be performed by the sensor module's processor 502E, by a processor (not shown) in the reader band 504, by a processor (not shown) in the smartphone 506, or by a combination of all three processors. In either case, the sensor data is processed and the results are displayed to the patient via the reader band 504 and to the healthcare provider via the smart device 506. The sensor data may include temperature information and optical properties of the insertion site. Other data and alerts may also be calculated and displayed based on the sensor data (e.g., alerts of detected infiltration and / or alerts of temperature difference between the temperature of the insertion site and the temperature of the reader band).

[0034] FIG. 6 is a flow chart 600 illustrating an example of data collection and processing of a smart IVC system. In a first step 602, the processor 502E controls the NIR emitter 502A to emit light, the NIR receiver 502B to receive the emitted light, and the temperature sensor 502C to monitor the temperature at the insertion site. In an optional step 604, the processor 502E records (e.g., in a local memory device) data readings representing the received light and the detected temperature. In step 606, the processor 502E controls the transceiver 502H to transmit the sensor data to the reader band 504, which then transmits the sensor data to the smart device 506 in step 608. In step 610, the reader band 504 and / or the smart device 506 analyze the sensor data, and then in step 612, the analyzed sensor data is displayed to the patient via the reader band 504 and to the healthcare provider via the smart device 506. In particular, the displayed information includes skin quality, skin temperature, warnings, and other patient information. In step 614, the sensor data and / or alerts may then be transmitted from the smart device 506 to the medical server 508 for storage in the patient's medical record.

[0035] Software Applications and Operational Flows FIG. 7 illustrates an example of a software application running on a healthcare provider's smart device 506. In this example, the smart device 506 displays sensor data 702, patient data 704, and control buttons 706-710. The sensor data 702 may indicate the quality of the skin at the insertion site as determined by an optical sensor and / or the temperature of the skin as determined by a temperature sensor. For example, if this displayed data exceeds a threshold, a "COMPLICATION" warning may be displayed to alert the healthcare provider to the situation. For example, for optical data, the threshold may be 1) a predetermined threshold of reflected light intensity at a particular frequency that correlates with the presence of an infiltrate, or 2) a comparison of reflected light intensity at a particular frequency over time. For temperature data, the threshold may be 1) a predetermined threshold of temperature at a particular frequency that correlates with the presence of an infiltrate, 2) a comparison of temperature over time, or 3) a comparison of the temperature at the insertion site to body temperature.

[0036] Patient data 704 includes, among other things, patient ID, patient age / weight, catheter insertion time, and catheter exchange time. Control buttons 706-710 allow the healthcare provider to, among other things, toggle between sensor readings (e.g., temperature and optical properties), access / change patient information, and navigate to the application's home screen.

[0037] FIG. 8 is a flow chart 800 showing the operation of the smart catheter system. In step 802, a patient is admitted to the hospital to receive IV therapy. In step 804, the patient is registered and provided with a reader band 504, and then in step 806, the patient is admitted to a room. In step 808, the healthcare provider (nurse taking care of the patient) opens a mobile application on the smart device 506 and wirelessly connects to the reader band 504. In step 810, the mobile application connects to the server 508 and transmits patient information (e.g., patient ID) to the server 508. The server 508 may then transmit the patient's medication information to the smart device 506. Then in step 812, the healthcare provider inserts the smart IVC assembly into the patient. Then in step 814, the sensor module of the smart IVC assembly 501 connects to the reader band 504 and starts monitoring the optical properties and / or temperature of the insertion site. The monitored data is then analyzed and displayed to the patient via the reader band 504 and to the healthcare provider via the smart device 506 in step 816. The data, as well as any alerts, may be forwarded by the smart device 506 to a medical server 508 for storage in the patient's medical record.

[0038] conclusion The steps of Figures 6-8 are performed by the sensor module, reader band, smart device, server, or combination thereof, by loading and executing software code or instructions tangibly stored in a tangible computer readable medium, such as a magnetic medium, such as a computer hard drive, an optical medium, such as an optical disk, a solid state memory, such as a flash memory, or other storage medium known in the art. In one example, the data is encrypted when written to memory, making it beneficial for use in any environment where privacy issues are a concern, such as protected health information. Any of the computer-implemented functions described herein, such as the steps of Figures 6-8, may be implemented in software code or instructions tangibly stored in a tangible computer readable medium. Upon loading and executing such software code or instructions by the computer, the controller may perform any of the computer functions described herein, including the steps of Figures 6-8 described herein.

[0039] The terms and expressions used herein shall be understood to have the ordinary meanings as given to such terms and expressions with respect to their respective fields of inquiry and study, unless a specific meaning is otherwise indicated herein. Relational terms such as first and second are used only to distinguish one entity or action from another and do not necessarily require or imply an actual relationship or hierarchy between the entities or actions. The terms "comprises", "includes", or variations of these terms are intended to cover a non-exclusive inclusion. A process, method, article, or apparatus that "comprises" or "includes" a list of elements or steps may include other elements or steps not expressly listed or that are not inherent to the element or step, rather than including only that exact element or step. An element preceded by "a" or "an" does not preclude the presence of additional identical elements in the process, method, article, or apparatus that "comprises" that element, unless otherwise constrained.

[0040] Unless otherwise stated, all measurements, values, ratings, positions, dimensions, sizes, and other specifications described in this specification, including the claims, are approximate and not exact. Such quantities are intended to have reasonable ranges consistent with the relevant functions and those customary in the relevant technical field. For example, unless expressly stated otherwise, parameter values, etc. may vary by ±10% from the quantities described.

[0041] It will also be seen that in the foregoing Detailed Description, 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, protected subject matter lies in less than all features of any single disclosed example. Accordingly, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0042] While the above describes what is believed 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 embodied in a variety of forms and examples and is applicable to many applications, only a few of which are described herein. It is intended that the following claims claim any and all modifications and variations that fall within the true scope of the present concepts.

Claims

1. a stabilization platform (202) configured to hold the IVC in a defined position relative to the patient's tissue; a sensor module (204) mechanically supported on said stabilization platform (202); Including, The sensor module (204) at least one sensor configured to detect a physical characteristic of the tissue of the patient and generate detected data representative of the physical characteristic of the tissue of the patient; a transceiver (502H) configured to transmit the detection data from the stabilization platform to a remote smart device (506). A smart intravenous catheter (IVC) assembly (201).

2. the stabilization platform (202) includes a slot (203), and the sensor module (204) includes a circuit board inserted into the slot (203); 2. The smart intravenous catheter (IVC) assembly (201) of claim 1.

3. the at least one sensor includes at least one of a temperature sensor (502C), a NIR emitter (502A), a photodiode (502B), a pressure sensor, a biosensor, or an optical flow sensor for detecting the physical characteristic of the tissue of the patient; A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

4. the sensor module (204) is attached to a portion of the stabilization platform between the IVC (212) and the tissue of the patient to position the at least one sensor at a determined distance from the tissue of the patient; A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

5. The at least one sensor is directly attached to the sensor module (204) or is remotely connected to the sensor module (204); A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

6. the sensor module (204) is at least one of covered with an antimicrobial coating, enclosed in medical grade shrink wrap, or enclosed in a hermetically sealed housing; A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

7. The stabilizing platform (202) comprises: a base portion (202A) for stabilizing the stabilization platform (202) relative to the tissue of the patient; a ramp portion (202B) for holding the IVC (212) at a defined position and angle relative to the tissue of the patient. A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

8. the stabilization platform (202) is made of a flexible rubber or flexible plastic material; A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

9. the stabilization platform (202) includes laterally extending wings (304A, 304B) for stabilizing the stabilization platform (202) relative to the tissue of the patient; A smart intravenous catheter (IVC) assembly (201) according to claim 1 or 2.

10. the sensor module (204) is attached to the wings (304A, 304B) or to a portion of the stabilization platform (202) between the wings (304A, 304B); 10. The smart intravenous catheter (IVC) assembly (201) of claim 9.

11. detecting a physical characteristic of the tissue of the patient with a sensor in a sensor module (204) attached to a stabilization platform (202) that holds an IVC (212) in a defined position relative to the tissue of the patient; generating, by the sensor of the sensor module (204), sensed data representative of the physical characteristic of tissue of the patient; transmitting the sensed data from the stabilization platform (202) to a remote smart device (506) via a transceiver (502H) of the sensor module (204); outputting data related to the detection data to the patient or to a healthcare provider by the smart device (506); A smart intravenous catheter (IVC) method comprising:

12. The smart device (506) outputs at least one of the detection data or a warning as output data.

12. The smart intravenous catheter (IVC) method of claim 11.

13. transmitting the detection data by the transceiver (502H) of the sensor module (204) to an electronic reader band of the smart device (506) worn by the patient; 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

14. transmitting the detection data by the transceiver (502H) of the sensor module (204) to the smart device (506) operated by the healthcare provider; 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

15. detecting, by the sensor of the sensor module (204), at least one of the following physical characteristics: a temperature of the tissue, an optical property of the tissue, or a biological sample of the tissue; 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

16. sending a control signal to the sensor module (204) by a software application of the smart device (506), the control signal controlling the sensor module (204) to detect the physical characteristic of the tissue of the patient and to transmit the detected data to the smart device (506); 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

17. transmitting, by the transceiver (502H) of the sensor module (204), the detected data to a medical database server for storage in the patient's record.

13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

18. calculating, by the sensor module (204) or the smart device (506), a health status of the tissue of the patient; outputting the health status of the tissue as output data by the smart device (506); 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

19. detecting the physical characteristic of the tissue at a location between the stabilization platform and the tissue with the sensor of the sensor module (204); 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

20. detecting the physical characteristic of the tissue at a location remote from the stabilization platform with the sensor of the sensor module (204); 13. A smart intravenous catheter (IVC) method according to claim 11 or 12.

21. A central processor; a first temperature sensor configured to measure a temperature of the patient at an IVC insertion site and generate first temperature data; and a first transceiver configured to transmit the first temperature data to the central processor; A sensor module (204) comprising: a second temperature sensor configured to measure a temperature of the patient at a reference site remote from the IVC insertion site and generate second temperature data; a second transceiver configured to transmit the second temperature data to the central processor; Equipped with the central processor is configured to compare the first temperature data to the second temperature data to determine a temperature differential and generate a signal when the temperature differential reaches a predetermined threshold. A smart intravenous catheter (IVC) assembly (201).

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