Smart venous 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 on June 17, 2021. The content of this application is hereby incorporated by reference in its 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 Art

[0003] The administration of fluids, medications, and parenteral nutrition by intravenous (IV) infusion therapy is one of the most common procedures in modern medicine. Approximately 80% of hospitalized patients receive IV therapy, and about 330 million disposable IV sets are sold annually in the United States. IV therapy is essential for simple and effective daily medical treatment of dehydration, infections, and diseases. However, despite the progress this life - saving procedure has made in recent years, there is still no simple solution that can continuously monitor and automatically detect when a disposable IV infusion fluid begins to leak, and thus when the medications and infusions intended for IV administration leak into and accumulate in the subcutaneous tissue. When wetting occurs, the damage to the patient can range from pain and redness to nerve / tissue damage and limb amputation. The frequency of IV wetting is surprisingly high. In addition to IV wetting, other complications such as phlebitis and catheter - related bloodstream infection (CRBSI) are also problematic. Phlebitis, which is related to inflammation of the vein, is the second most frequently occurring IV complication. CRBSI, caused by the presence of bacteremia due to an intravenous catheter (IVC), is one of the most serious complications that can lead infected patients to surgical intervention and possibly death. Therefore, it is important to detect IV complications as early as possible before they become severe.

Summary of the Invention

[0004] A smart venous catheter (IVC) assembly includes a stabilization platform configured to hold the IVC in a predetermined position relative to the patient's tissue, and a sensor module mechanically supported by the stabilization platform. The sensor module includes at least one sensor and a transceiver, the sensor being configured to detect the physical characteristics of the patient's tissue and generate detection data representing the physical characteristics of the patient's tissue, and the transceiver being configured to transmit the detection data from the stabilization platform to a remote smart device.

[0005] A smart intravenous catheter (IVC) method involves detecting the physical characteristics of a patient's tissue using sensors in a sensor module mounted on a stabilization platform that holds the IVC in a predetermined position relative to the patient's tissue. The sensor module's sensors generate detection data representing the physical characteristics of the patient's tissue, the sensor module's transceiver transmits the detection data from the stabilization platform to a remote smart device, and the smart device outputs output data related to the detection data to the patient or healthcare provider.

[0006] The smart venous catheter (IVC) assembly comprises a central processor and a sensor module, the sensor module comprising a first temperature sensor configured to measure body temperature at the patient's IVC insertion site and 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 body temperature at a reference site of the patient away from the IVC insertion site and 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 the temperature difference and to generate a signal when the temperature difference reaches a predetermined threshold. [Brief explanation of the drawing]

[0007] [Figure 1A]A cross-sectional view of a part of the skin relating to one aspect of this disclosure. [Figure 1B] A perspective view of a venous catheter according to one aspect of this disclosure. [Figure 2A] A perspective view of a smart venous catheter connected to a leader band according to one aspect of the present disclosure. [Figure 2B] A perspective view of a sensor module for a smart venous catheter shown in Figure 2A, relating to one aspect of the present disclosure. [Figure 2C] Figure 2B is a perspective view of the sensor module according to one aspect of the present disclosure, showing an example of light reflection from a part of human skin. [Figure 2D] A side view of the smart venous catheter shown in Figure 2A, which includes a venous catheter inserted into a patient, according to one aspect of the present disclosure. [Figure 2E] A perspective view of a smart venous catheter assembly comprising a remotely located NIR emitter and connected to a sensor module via a cable, according to one aspect of the present disclosure. [Figure 2F] A side view of the smart venous catheter assembly shown in Figure 2E, which includes a venous catheter inserted into a patient, according to one aspect of the present disclosure. [Figure 2G] A cross-sectional view of a smart venous catheter assembly, Figure 2A, having a gap for holding a sensor module, according to one aspect of the present disclosure. [Figure 2H] A perspective view of a sensor module equipped with multiple temperature sensors according to one aspect of the present disclosure. [Figure 3A] Three perspective views of a smart venous catheter assembly with stabilizing wings according to one aspect of the present disclosure. [Figure 3B] This is a perspective view of a smart venous catheter assembly equipped with a stabilizing wing and an internal sensor module according to one aspect of the present disclosure. [Figure 4] Two perspective views of the sensor module shown in Figure 3B, relating to one aspect of this disclosure. [Figure 5] A diagram of a smart venous catheter system according to one aspect of this disclosure. [Figure 6]A flowchart illustrating data collection and processing for a smart venous catheter system according to one aspect of this disclosure. [Figure 7] A diagram of a smart device that runs a software application for a smart venous catheter system according to one aspect of this disclosure. [Figure 8] A flowchart illustrating the operation of a smart venous catheter system according to one aspect of this disclosure. [Modes for carrying out the invention]

[0008] The following detailed explanation includes numerous specific details as examples, for the purpose of providing a complete understanding of the relevant teachings. However, it should be apparent to those skilled in the art that these teachings can be carried out without such details. In other cases, well-known methods, procedures, components, and circuits are described at a relatively high level, with details omitted, for the purpose of avoiding unnecessary ambiguity of the aspects of these teachings.

[0009] Introduction The devices, systems, and methods disclosed herein are provided for the early detection of venous catheter (IVC) complications such as phlebitis, infiltration, and CRBSI. The devices, systems, and methods help clinicians and healthcare providers (e.g., physicians, nurses, and technicians) to diagnose venous complications as early as possible before they worsen. The devices, systems, and methods can continuously monitor the IVC insertion site and be integrated with the patient's existing electronic medical record (EMR). The devices, systems, and methods also help to secure the catheter and prevent IVC dislodgement or twisting.

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

[0011] The example of an IVC shown in Figure 1B illustrates an IVC inserted into the patient's skin. This insertion can occur in various parts of the body (e.g., arm, hand, neck, etc.). The IVC may include a catheter 124, a catheter hub 122, a finger depressure plate 121, a flashback chamber 123, and a catheter needle 126. During the procedure, the catheter needle 126 is inserted into the skin and advanced until a flashback is visible in the flashback chamber 123 and it is confirmed that the catheter needle 126 has punctured the target vein. Once the 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 depressure plate 121, the catheter 124 is withdrawn from the needle and advanced into the vein until a flashback is visible in the catheter 124 and it is confirmed that the catheter 124 is positioned in the vein. Once catheter 124 is fully inserted into the vein, the needle is withdrawn from catheter hub 122, a septum (not shown) closes, and the flow of blood from catheter hub 122 is stopped. When a Luer connector is inserted into catheter hub 122, the septum is forcibly opened, allowing blood to be collected or medication to be administered to the patient.

[0012] However, as mentioned above, leakage of IV fluid or medication into surrounding tissue can lead to wetting. This can occur due to improper catheter placement or removal. In one example, a smart IVC assembly is used to avoid or monitor such conditions. A smart IVC assembly includes a stabilization platform (e.g., made of a soft material) to reduce catheter removal, and a sensor module placed between the stabilization platform and the patient's skin. The sensor module may 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 that is absorbed and reflected by biological tissue and any fluid present within it, such as near-infrared (NIR) light. The spectrum associated with NIR is penetrating, and changes in reflected energy are captured by the sensor's receiver and processed to determine whether the area around the IVC site is normal or wet. In one example, an NIR emitter emits NIR into the skin tissue, and a photodetector collects the emitted optical signal. When IV fluid wets the interstitial space, the optical density of the tissue changes, resulting in a change in the collected optical signal. The difference in the measured signals suggests that the wetting fluid is present in the subcutaneous layer.

[0013] Device / System Hardware An example of a smart IVC assembly is shown in FIG. 2A, and the smart IVC catheter assembly 201 is connected (either wired or wirelessly) to the 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 lamp portion 202B, a catheter mount 202C, and slots (not shown) for holding the sensor module 204 in place. The stabilization platform 202 may be manufactured from a sufficiently robust material (e.g., plastic, rubber, etc.) to hold the IVC 212 in place while providing a comfortable and hygienic state for the patient. The IVC 212 may be any type of catheter as long as it 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) for fixation.

[0014] In fact, when the 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. When the patient is housed in a hospital room, a nurse uses a mobile application (not shown) via a mobile device (not shown) to register the patient, and the patient's information becomes visible within the application. Then, the nurse performs an IVC procedure on the patient, inserts the catheter using the catheter stabilization platform with the sensing module inserted as normal, and places a bandage on the smart IVC assembly to secure 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 is rested on the patient's skin (e.g., arm, hand, etc.), and a bandage may be attached to the base portion 202A to prevent unwanted movement. The stabilization platform 202 holds the IVC 212 at an appropriate angle to avoid kinking or removal of the catheter.

[0015] Next, a connection is established between the sensor module and the reader band (e.g., wirelessly via a wireless connection 208A or wired via a 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 (Registered trademark) , Bluetooth (Registered trademark) , radio frequency identification (RFID), or any other equivalent wireless protocol. Once the connection is complete, the nurse begins monitoring the initial clinical signs and symptoms of the injection site through a mobile application on the mobile device. The patient can also receive direct auditory and visual notifications 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 photodetector 213, a temperature sensor 214, a battery 219, support electronics 215, and a processor 217, which are 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 called a micro battery (e.g., 0.5 mm × 3.6 mm × 5.6 mm, 45 mAh), such a battery may be replaceable and may be designed to last the operating 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 supplied 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. The dimensions of the sensor module 204 may vary depending on the dimensions of the stabilization platform 202 and the mounted electronic equipment. For example, the dimensions of the sensor module 204 may be designed to fit into the lower mounting slot of the stabilization platform 20. The entire sensor module may be sealed and sterilized (e.g., cleaned with alcohol) for later reuse on another patient.

[0018] During operation, as shown in Figure 2C, the sensor module 204 is used to monitor the presence of a wetting fluid in the patient's skin. For example, in Figure (A), the sensor module 204 emits light (e.g., NIR light) 216 toward the patient's skin located beneath the stabilizing platform 202. The light 226 is then absorbed / reflected in different ways depending on the presence or absence of the wetting fluid. The reflected light 224 is then detected by an NIR receiver (e.g., a photodiode) and processed by a processor 214 (to determine, for example, the presence or absence of the wetting fluid). Another schematic of this processing is shown in Figure (B), where an NIR source 228 penetrates the skin tissue 102 and interacts with molecules of the injected fluid 232. The infrared radiation 224 reflected by these molecules is detected by an NIR detector 230 and processed by a processor 214. Although not shown, the sensor module may include a biosensor that detects specific molecules in the patient's biological sample. For example, a biosensor may include a probe that comes into contact with a patient's blood to determine the presence of molecules indicating wetness or other medical problems.

[0019] Figure 2D shows an example of a smart IVC assembly 240 that is inserted and monitors the patient's insertion site. In this example, the catheter of the smart IVC assembly 242 is inserted into the patient's vein 108, and the 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 leader band monitor the patient's skin. The sensor module analyzes reflected light from the skin 102 to detect the presence or absence of infiltration 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 whether the temperature of the injection site is above or below body temperature, which may indicate complications at the injection site.

[0020] For example, if a nurse receives a notification from a mobile application that there is an average temperature rise (e.g., 2°C) detected by a 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 / exudation. According to one study, a temperature drop of less than 0.7°C / cm is the optimal cutoff for assessing exudation in a patient. If the body temperature monitored via the mobile application exceeds 38.3°C, critically ill patients should be evaluated for infection and may be diagnosed with CRBSI.

[0021] In another example, in the smart IVC assembly 250 shown in Figure 2E, the NIR emitter 252 is 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 wire (or wirelessly) to 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, Figure 2F shows an example of a smart IVC assembly 254 that is inserted and monitors the patient's insertion site. In this example, the catheter of the smart IVC assembly 254 is inserted into the patient's vein 108, and the stabilization platform of the smart IVC assembly 254 is fixed to the patient's skin (e.g., arm). During IVC monitoring, an optical emitter 252 is positioned 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 the sensor module) analyzes the reflected light 262 from the skin 102 to detect the presence or absence of infiltrating fluid 248. This configuration is beneficial because it allows monitoring of the entire length of the catheter from the insertion point to the distal end located in the patient's vein (e.g., NIR light traverses the length of the catheter). The infiltrating fluid 248 present along this entire region can be detected by the absorption / reflection of NIR light by the fluid.

[0023] Figure 2G shows a cross-sectional view of the smart IVC assembly 201 shown in Figure 2A. This figure clearly shows that the stabilization platform 202 includes a slot 203 on its bottom surface for inserting and holding a sensor module 204 (not 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 at a certain distance from the user's skin (when inserted into the slot 203). Alternatively, the stabilization platform 202 may be configured to accommodate a contact temperature sensor by not having a gap 260, so that the sensor module 204 is held directly against the user's skin (when inserted into the slot 203). This configuration ensures that the sensor makes reliable contact with the user's skin, allowing for accurate sensor readings.

[0024] Although the sensor module is described as having one temperature sensor 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 a configuration may include a primary temperature sensor at the insertion site and at least one proximal temperature sensor further away from the insertion site. Rather than comparing the reading of the primary temperature sensor to the threshold, the reading of the primary temperature sensor is compared to the reading of the proximal temperature sensor to determine the presence of fluid infiltration.

[0025] For example, Figure 2H shows a perspective view of a sensor module 270, which has a temperature sensor 272 (e.g., a primary sensor located closest to the insertion site) for measuring the insertion site temperature (IST), and one or more additional temperature sensors 274, 276, 278 located at various positions near the insertion site for measuring the proximal reference temperature (PRT). In this example, the PRT can be calculated as the average reading of all three additional temperature sensors.

[0026] In either case, the temperature difference ΔT is calculated between ISR and PRT (ΔT = IST - PRT). Under normal conditions, ΔT should be close to zero. However, when the insertion site begins to heat up due to fluid wetting, ΔT becomes non-zero (for example, ISR becomes greater than PRT). Therefore, ΔT can be compared to a non-zero threshold to determine whether or not fluid wetting is occurring.

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

[0028] In one example, the IVC 302 of the smart IVC assembly in Figure 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 leader band (not shown) monitor the patient's skin. The optical sensor 310 (having an integrated emitter or a remotely located emitter) emits / detects light, which is then analyzed by a processor (not shown) to determine the presence or absence of infiltration fluid. To determine whether the temperature at the injection site is above or below body temperature, 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.

[0029] Rather than placing the optical sensor and temperature sensor separately under different stabilization 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 stabilization wings 324A / 324B, as shown in Figure 3B, or 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 the IVC 320 in place.

[0030] The sensor module 328 may be configured to be disposable (e.g., integrated with a stabilization platform) or reusable (e.g., insertable into and removable from a 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 Figures 4(A) and (B). The sensor circuit board 408 may be electrically connected to pins 404 to provide access to data input / output and / or charging power. The autoclave housing and pins may be sealed within a steam-sterilizable and reusable material (e.g., glass, metal, ceramic, etc.). In practice, at least a portion of the autoclave housing is transparent so that the optical sensor can monitor the patient's skin. This reusable configuration allows the healthcare provider to insert the sensor module into the IVC stabilization platform for use with the first patient. Once the first patient's IVC treatment is complete, the healthcare provider removes, sterilizes, and inserts the sensor module into a new IVC stabilization platform for use with a second patient.

[0031] In any configuration, the smart IVC assembly provides an integrated solution in which the sensor module and stabilization platform are integrated with the IVC. This avoids bulky equipment and provides comfort to the patient. The sensor module, which is to be inserted into 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 transparent plastic case) so that it can be disinfected with alcohol, and this waterproof coating ensures that the electronic components are waterproof. In another example, the sensor module is sealed in a reusable material (e.g., glass, metal, ceramic, etc.) that can be sterilized by steam.

[0032] The entire system and data processing As shown in Figure 5, in addition to the smart IVC assembly 501 and the leader band 504, the entire smart IVC system 500 includes a smart device 506 (e.g., a smartphone, tablet, laptop, etc.) and a medical server 508, which work together to monitor the patient's IVC injection site, issue warnings, and record results. For example, when the smart IVC assembly 502 is inserted into a slot in the stabilization platform and driven (e.g., by a switch or button not shown) and the catheter is inserted into the patient, the sensor module 502 begins monitoring the insertion site. Specifically, the processor 502E executes a program in memory and controls the transceiver 502H to wirelessly connect with the leader band 504, the NIR emitter 502A to start emitting NIR light, the NIR receiver 502B to start detecting NIR light, and the temperature sensor 502C to start monitoring the temperature of the insertion site. The NIR emitter 502A, temperature sensor 502C, and photodiode 502B are controlled via an analog-to-digital converter (ADC) 502G. Various devices / components within the sensor module 502 are powered by a power supply 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 readerband 504. Specifically, the processor 502E may transmit raw or processed sensor data to the readerband 504. The sensor data can then be transferred from the readerband 504 to the smartphone 506. Processing of the raw data may be performed by the processor 502E of the sensor module, by the processor of the readerband 504 (not shown), by the processor of the smartphone 506 (not shown), or by a combination of all three processors. In any case, the sensor data is processed, and the results are displayed to the patient via the readerband 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 warnings may also be calculated and displayed based on the sensor data (e.g., warnings of detected infiltration and / or warnings of temperature differences between the insertion site temperature and the readerband temperature).

[0034] Figure 6 is a flowchart 600 illustrating an example of data acquisition and processing in a smart IVC system. In the 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 of the insertion site. In an optional step 604, the processor 502E records data readings (e.g., to a local memory device) representing the received light and detected temperature. In step 606, the processor 502E controls the transceiver 502H to transmit the sensor data to the readerband 504, and then in step 608, the readerband 504 transmits the sensor data to the smart device 506. In step 610, the readerband 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 readerband 504 and to the healthcare provider via the smart device 506. In particular, the displayed information may include skin quality, skin temperature, warnings, and other patient information. Next, in step 614, sensor data and / or alerts may be sent from the smart device 506 to the medical server 508 for storage in the patient's medical record.

[0035] Software applications and operational flows Figure 7 shows 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. Sensor data 702 may indicate the quality of the skin at the insertion site as determined by an optical sensor and / or the skin temperature as determined by a temperature sensor. For example, if this displayed data exceeds a threshold, a warning "COMPLICATION" is displayed to alert the healthcare provider to the situation. For example, in the case of optical data, the threshold may be 1) a predetermined threshold of reflected light intensity at a specific frequency correlated with the presence of infiltration, or 2) a comparison of reflected light intensity at a specific frequency over time. In the case of temperature data, the threshold may be 1) a predetermined threshold of temperature at a specific frequency correlated with the presence of infiltration, 2) a comparison of temperature over time, or 3) a comparison of the temperature at the insertion site with body temperature.

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

[0037] Figure 8 is a flowchart 800 illustrating the operation of the smart catheter system. In step 802, the patient is admitted to the hospital to receive intravenous therapy. In step 804, the patient is registered and provided with a readerband 504, and then in step 806, the patient is admitted to a hospital room. In step 808, the healthcare provider (a nurse caring for the patient) opens a mobile application on the smart device 506 and connects wirelessly to the readerband 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 readerband 504 and begins monitoring the optical properties and / or temperature of the insertion site. Next, in step 816, the monitored data is analyzed and displayed to the patient via the readerband 504 and to the healthcare provider via the smart device 506. The data, as well as any alerts, may be transferred by the smart device 506 to the medical server 508 for storage in the patient's medical record.

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

[0039] The terms and expressions used herein will be understood to have the ordinary meanings given to them in relation to the respective fields of the corresponding research and study, unless otherwise specified herein. The first and second, etc., relational terms are used solely to distinguish one entity or action from another and do not necessarily require or suggest any actual relationship or hierarchy between those entities or actions. The terms “equip,” “include,” or variations thereof are intended to cover non-exclusive inclusion. A process, method, article, or apparatus that “equips” or “includes” an enumeration of elements or steps may not include only those elements or steps, but may include other elements or steps not explicitly enumerated, or other elements or steps not inherently present in those elements or steps. An element preceded by “a” or “an” does not, unless specifically restricted, prevent the presence of additional identical elements within a process, method, article, or apparatus that “equips” that element.

[0040] Unless otherwise stated, all measurements, numerical values, ratings, locations, sizes, dimensions, and other specifications described herein, including in the claims, are approximate and not precise. Such quantities are intended to have a reasonable range that is consistent with the relevant function and what is customary in the relevant art. For example, unless explicitly stated otherwise, parameter values, etc., may vary by ±10% from the quantities described.

[0041] Furthermore, as can be seen in the detailed description above, various features are grouped into various examples for the purpose of streamlining the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed examples require more features than are explicitly stated in each claim. Rather, as the following claims reflect, the subject matter to be protected is less than all the features of any single disclosed example. Therefore, the following claims are thus incorporated into the detailed description, and each claim stands alone as individually claimed subject matter.

[0042] While the above describes what is considered the best mode and other examples, it should be understood that various modifications can be made therein, that the subject matter disclosed herein can be implemented in various forms and examples, and that it is applicable to many uses, of which only some are described here. The following claims are intended to assert all modifications and variations that fall within the true scope of this concept.

Claims

1. A stabilization platform (202) configured to hold the IVC in a predetermined position relative to the patient's tissue, A sensor module (204) mechanically supported on the stabilization platform (202), Includes, The sensor module (204) At least one sensor configured to detect the physical characteristics of the patient's tissue and to generate detection data representing the physical characteristics of the patient's tissue, The system includes a transceiver (502H) configured to transmit the detection data from the stabilization platform to a remote smart device (506), The first of the at least one sensors is a temperature sensor (502C), The second sensor among the at least one of the sensors is an optical sensor (253) comprising an NIR emitter (502A) and a receiver. The optical sensor (253) is configured to analyze reflected light (262) from the skin (102) in order to detect the presence or absence of a wetting fluid (248). 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). The smart venous catheter (IVC) assembly (201) according to claim 1.

3. The at least one sensor includes at least one of a photodiode (502B), a pressure sensor, a biosensor, or an optical flow sensor to detect the physical characteristics of the patient's tissue. A smart venous 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 patient's tissue in order to position the at least one sensor at a predetermined distance from the patient's tissue. A smart venous catheter (IVC) assembly (201) according to claim 1 or 2.

5. The at least one of the sensors is either directly attached to the sensor module (204) or connected to the sensor module (204) at a distance. A smart venous catheter (IVC) assembly (201) according to claim 1 or 2.

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

7. The stabilization platform (202) is A base portion (202A) for stabilizing the stabilization platform (202) with respect to the tissue of the patient, A ramp section (202B) for holding the IVC (212) at a predetermined position and angle relative to the tissue of the patient, A smart venous catheter (IVC) assembly (201) according to claim 1 or 2.

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

9. The stabilization platform (202) includes wings (304A, 304B) that extend laterally to stabilize the stabilization platform (202) relative to the patient's tissue. A smart venous 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 part of the stabilization platform (202) between the wings (304A, 304B). The smart venous catheter (IVC) assembly (201) according to claim 9.

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