# US 11,992,292 B2 · Diagnostic systems and methods including temperature-sensing vascular devices > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,992,292 B2 - Document ID: US11992292B2 - Status: Granted - Kind: B2 - Application number: 17/143,965 - Filed: 2021-01-07 - Published: 2021-07-08 - Granted: 2024-05-28 - Earliest claimed: 2020-01-07 - Assignees: Bard Access Systems, Inc. - Applicants: Bard Access Systems, Inc. - Inventors: Samuel Akins; Gidon Ofek - Web page: https://patentgrep.com/patent/US11992292B2 ## CPC - A61B 5/01: Measuring temperature of body parts {; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue} (clinical contact thermometers G01K13/20) - A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)} - A61B 5/0008: {Temperature signals} - A61B 5/024: Measuring pulse rate or heart rate - A61B 5/029: Measuring blood output from the heart, e.g. minute volume - A61B 5/318: Heart-related electrical modalities, e.g. electrocardiography [ECG] - A61B 5/6852: {Catheters} - A61B 5/6876: {Blood vessel} - A61B 5/742: {using visual displays (displays for heart-related electrical signals, e.g. ECG, A61B5/339)} - A61B 5/7475: {User input or interface means, e.g. keyboard, pointing device, joystick} - A61B 2562/0271: Thermal or temperature sensors - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) ## Abstract Diagnostic systems and methods including temperature-sensing vascular devices. A diagnostic system can include a catheter assembly for establishing vascular or other access within a body of a patient. The catheter assembly can be equipped with one or more sensors such as temperature sensors that enable monitoring of one or more physiological aspects of the patient, such as temperature, when a portion of the catheter assembly is disposed within the patient. The catheter assembly can be configured to transmit or otherwise forward data relating to the physiological aspects to another location, such as a console, a smartphone or another mobile device, a nurse station, a patient electronic medical record, etc. A method of the diagnostic system can include an instantiating step of instantiating in memory of the console a diagnostic process having one or more functions for at least processing temperature data from the catheter assembly. ## Claims ### Claim 1 A diagnostic system, comprising: a catheter assembly including: a catheter tube defining at least one lumen extending between a proximal end and a distal end; a hub operably attached to the catheter tube; an extension leg operably attached to the hub, the hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube; and a plurality of temperature sensors disposed within the catheter tube including a primary catheter-tube temperature sensor and a secondary catheter-tube temperature sensor proximal of the primary catheter-tube temperature sensor for determining malposition of the catheter tube in a vasculature of a patient, each temperature sensor of the primary and secondary catheter-tube temperature sensors configured for temperature measurement in the catheter tube; a console configured to communicate with the catheter assembly, the console including memory, a processor, and a proportional-integral-derivative (PID) controller, wherein the PID controller is configured to maintain the primary catheter-tube temperature sensor at a set temperature, and monitor an amount of power utilized in maintaining the primary catheter-tube temperature sensor at the set temperature, wherein the amount of power utilized is proportional to blood flowrate, and wherein blood flowrate is indicative of catheter placement or catheter malposition, and wherein the processor is configured to measure a blood temperature with the secondary catheter-tube temperature sensor as the catheter tube is moved through the vasculature, wherein a first blood temperature indicates movement in a direction against blood flow, wherein a second blood temperature elevated in relation to the first blood temperature indicates movement in a direction with blood flow, and wherein determining whether the catheter tube is moving in the direction against blood flood or in the direction with blood flow is indicative of the catheter placement or the catheter malposition; and a display screen configured to communicate with the console, the display screen configured to display a graphical user interface (“GUI”) including at least a temperature reading associated with the plurality of temperature sensors. ### Claim 2 (depends on 1) The diagnostic system of claim 1, wherein the console is configured to instantiate a display server configured to coordinate input to the console and output from the console, the output including the GUI. ### Claim 3 (depends on 1) The diagnostic system of claim 1, wherein the memory includes instructions for processing the temperature measurement from any of the plurality of temperature sensors of the catheter assembly while the catheter tube is disposed in the vasculature of the patient. ### Claim 4 (depends on 1) The diagnostic system of claim 1, wherein each temperature sensor of the plurality of temperature sensors is disposed in a different location of a plurality of locations along a length of the catheter tube for measuring a local temperature. ### Claim 5 (depends on 4) The diagnostic system of claim 4, wherein the memory includes instructions for monitoring local temperature changes or trends thereof of the plurality of temperature sensors or the temperature sensors respectively at one or more locations of plurality of the locations. ### Claim 6 (depends on 1) The diagnostic system of claim 1, wherein the processor is configured to provide a console-based alert when a flushing-compliant temperature change does not occur at the primary catheter-tube temperature sensor, the secondary catheter-tube temperature sensor, or both the primary catheter-tube temperature sensor and the secondary catheter-tube temperature sensor as expected from room-temperature flushate being flushed through the catheter assembly after patient-temperature blood is drawn from the catheter assembly or at recommended intervals or instances. ### Claim 7 (depends on 1) The diagnostic system of claim 1, wherein the PID controller is communicatively coupled to the primary catheter-tube temperature sensor, and wherein the set temperature is a set number of degrees above the blood temperature. ### Claim 8 (depends on 1) The diagnostic system of claim 1, wherein a plurality of electrodes are disposed concentrically on the catheter tube, wherein the plurality of electrodes are employed to obtain volumetric measurements resulting in a determination of a size of a vessel in which the catheter tube is disposed. ### Claim 9 (depends on 8) The diagnostic system of claim 8, wherein the GUI provides an indication of a location of the catheter tube in the vasculature of the patient. ### Claim 10 (depends on 1) The diagnostic system of claim 1, further comprising an electrocardiogram (“ECG”) stylet or leads embedded within the catheter assembly, wherein the ECG stylet or leads obtain ECG data while the ECG stylet is disposed in the catheter tube and the catheter tube is disposed in the vasculature of the patient to confirm location of a tip of the catheter tube, monitor migration of the tip of the catheter tube, determine heart rate, or a combination thereof.