Diagnostic systems and methods including a temperature sensing vasculature device

Abstract

Diagnostic systems and methods, including a temperature-sensing vascular device. The diagnostic system can include a catheter assembly for establishing a vascular or other access in a patient. The catheter assembly can be equipped with one or more sensors, such as temperature sensors, that can monitor 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 related to the physiological aspects to another location, such as a console, a smartphone or another mobile device, a nurse station, a patient's electronic medical record, etc. The method of the diagnostic system can include an instantiation step: instantiating a diagnostic process in a memory of the console, the diagnostic process having one or more functions for at least processing temperature data from the catheter assembly.

Description

[0001] Priority

[0002] This application claims the benefit of priority of U.S. Provisional Application No. 62 / 958,299, filed on January 7, 2020, the entire contents of which are incorporated herein by reference. Background Art

[0003] A patient's body temperature can be measured by any of a number of existing temperature probes, including but not limited to skin temperature probes, oral thermometers, tympanic thermometers, esophageal temperature probes, rectal thermometers, temperature-sensing bladder catheters, etc. While effective, the foregoing temperature probes are generally limited to making instantaneous measurements and providing temperature data for specific tissues at specific locations, which limits the application of such temperature probes in treating patients. There is a need for a temperature probe having one or more temperature sensors, the temperature probe being combined with an enhancement device for enhancing temperature data to assist in patient diagnosis and expand treatment options.

[0004] Disclosed herein are diagnostic systems and methods including a temperature-sensing vascular device that solve the above problems. Summary of the Invention

[0005] Disclosed herein is a diagnostic system that, in some embodiments, includes a catheter assembly, a console, and a display screen. The catheter assembly includes a catheter tube, a hub operably attached to the catheter tube, an extension leg operably attached to the hub, and a single temperature sensor or multiple temperature sensors. The catheter tube defines at least one lumen extending between a proximal end and a distal end. The hub and the extension leg define at least one fluid channel in fluid communication with the lumen of the catheter tube. The single temperature sensor is disposed within the catheter tube, the hub, or the extension leg and is configured for temperature measurement therein. The multiple temperature sensors are disposed within the catheter tube, the hub, the extension leg, or a combination thereof and are configured for temperature measurement therein. The console is configured to communicate with the catheter assembly. The console includes a memory and a processor configured to instantiate a diagnostic process having at least one or more functions for processing temperature data when the catheter tube is placed within a patient's vascular system. The display screen is configured to communicate with the console. The display screen is configured to display a graphical user interface (“GUI”) that includes at least temperature readings associated with the one or more sensors.

[0006] In some embodiments, the console is configured to instantiate a display server that is configured to coordinate input to and output from the console. The input includes selection of the one or more functions of the diagnostic process. The output includes the GUI.

[0007] In some embodiments, the memory includes one or more temperature data processing algorithms for processing temperature data from any temperature sensors of the catheter assembly using the diagnostic process when the catheter lumen is placed in a patient's vasculature.

[0008] In some embodiments, the catheter lumen includes the plurality of temperature sensors. Each of the plurality of temperature sensors is disposed at a different one of a plurality of positions along the length of the catheter lumen for measuring local temperature.

[0009] In some embodiments, the memory includes an infection diagnostic algorithm for diagnosing an infection in the patient's vasculature or subcutaneous tissue using the diagnostic process at any one or more of the plurality of positions along the length of the catheter lumen. Diagnosis of the infection with the infection diagnostic algorithm is based on the local temperature change or its trend of the temperature sensor or temperature sensors at one or more of the plurality of positions, respectively.

[0010] In some embodiments, the catheter lumen includes at least one catheter lumen temperature sensor disposed within the catheter lumen, at least one hub temperature sensor disposed within the hub, or a combination thereof, which is configured for temperature measurement within the catheter lumen, the hub, or both the catheter lumen and the hub.

[0011] In some embodiments, one or more functions of the diagnostic process include a flush compliance function. The flush compliance function is configured to provide a console-based alert when there is no temperature change indicative of a compliant flush at the catheter lumen temperature sensor, the hub temperature sensor, or both the catheter lumen temperature sensor and the hub temperature sensor when room temperature flush fluid is flushed through the catheter assembly after withdrawal of patient body temperature blood from the catheter assembly or at a recommended time interval or instance.

[0012] In some embodiments, the catheter lumen includes a main catheter lumen temperature sensor disposed within the catheter lumen. The console includes a proportional-integral-derivative (“PID”) controller that is communicatively coupled to the main catheter lumen temperature sensor. The PID controller is configured to maintain the main catheter lumen temperature sensor at a set number of degrees above blood temperature.

[0013] In some embodiments, one or more functions of the diagnostic process include a blood flow rate function. According to the blood flow rate function, the diagnostic process utilizes a blood flow rate algorithm to monitor the blood flow rate around the main catheter lumen temperature sensor by the amount of power required to maintain the main catheter lumen temperature sensor at a set number of degrees above blood temperature. The blood flow rate is proportional to the amount of power required to maintain the main catheter lumen temperature sensor at a set number of degrees above blood temperature.

[0014] In some embodiments, one or more functions of the diagnostic process include a cardiac parameter function. According to the cardiac parameter function, the diagnostic process utilizes a blood flow rate algorithm in combination with a cardiac parameter algorithm to determine cardiac parameters including cardiac stroke volume.

[0015] In some embodiments, one or more functions of the diagnostic process include a catheter tracking function. According to the catheter tracking function, the diagnostic process utilizes a blood flow rate algorithm in combination with a catheter tracking algorithm to determine when a main catheter lumen temperature sensor is advanced past a vascular junction based on an increase in the volume of blood flow.

[0016] In some embodiments, the diagnostic process is configured to provide catheter tracking data generated by the catheter tracking algorithm as a display server input for display server output to a GUI on a display screen. The display server output of the GUI provides an indication of the position of the catheter lumen within the patient's vasculature to the clinician.

[0017] In some embodiments, the catheter lumen includes an auxiliary catheter lumen temperature sensor disposed within the catheter lumen proximal to the main catheter lumen temperature sensor for determining misalignment of the catheter lumen within the patient's vasculature.

[0018] In some embodiments, the catheter tracking function is configured to determine misalignment of the catheter based on temperature data from the auxiliary catheter lumen temperature sensor. When the catheter lumen moves against the blood flow, the temperature data from the auxiliary catheter lumen temperature sensor indicates the patient's blood temperature. Since the main catheter lumen temperature sensor is at a set number of degrees higher than the blood temperature, when the catheter lumen moves with the blood flow, the temperature data from the auxiliary catheter lumen temperature sensor indicates an increase in blood temperature.

[0019] In some embodiments, the diagnostic system further includes an electrocardiogram (“ECG”) probe or wire embedded within the catheter assembly. One or more functions of the diagnostic process include an ECG function for processing ECG data when the ECG probe is placed within the catheter lumen and the catheter lumen is placed within the patient's vasculature. The ECG function confirms the position of the catheter lumen tip, monitors migration of the catheter lumen tip, determines heart rate, or a combination thereof.

[0020] The present disclosure also discloses a diagnostic system. In some embodiments, the diagnostic system includes a vascular access device, a console, and a display screen. The vascular access device includes an elongate tube and a single temperature sensor. The elongate tube defines at least one lumen extending between a proximal end and a distal end of the elongate tube. The single temperature sensor disposed within a distal portion of the elongate tube is configured for temperature measurement therein. The console is configured to communicate with the vascular access device. The console includes a memory and a processor, which are configured to instantiate a diagnostic process having at least a function of processing temperature data when the distal portion of the elongate tube is placed within a patient's vascular system. The console further includes a PID controller communicatively coupled to the temperature sensor. The PID controller is configured to maintain the temperature sensor at a set number of degrees above the blood temperature. The display screen is configured to communicate with the console. The display screen is configured to display a GUI, which at least includes a temperature reading associated with the temperature sensor.

[0021] In some embodiments, the function of the diagnostic process is a blood flow rate function. According to the blood flow rate function, the diagnostic process utilizes a blood flow rate algorithm to monitor the blood flow rate around the temperature sensor by the amount of power required to maintain the temperature sensor at a set number of degrees above the blood temperature. The blood flow rate is proportional to the amount of power required to maintain the temperature sensor at a set number of degrees above the blood temperature.

[0022] In some embodiments, the console is configured to instantiate a display server, which is configured to coordinate inputs to and outputs from the console. The inputs include local maxima of blood flow rate data generated by the blood flow rate algorithm. The outputs include an indication of successful placement of the distal portion of the elongate tube within the patient's vascular system in the GUI on the display screen.

[0023] The present disclosure also discloses a method for a diagnostic system. In some embodiments, the method includes an instantiation step: instantiating a diagnostic process in the memory of the console, the diagnostic process having at least one or more functions for processing temperature data. The method further includes a sending step: sending temperature data from a catheter assembly to the console. The catheter assembly has a single temperature sensor disposed within a catheter tube, a hub, or an extension leg of the catheter assembly. Optionally, the catheter assembly has a plurality of temperature sensors disposed within the catheter tube, the hub, the extension leg, or a combination thereof. The method further includes a loading step: loading the temperature data into the memory. The method further includes a processing step: processing the temperature data with a processor of the console according to the one or more functions for processing temperature data. The method further includes a display step: displaying at least a temperature reading associated with the one or more sensors in a GUI on a display screen configured to communicate with the console.

[0024] In some embodiments, the method further includes a monitoring step: monitoring the blood flow rate around any temperature sensors of a catheter assembly disposed within a patient's vasculature using a blood flow rate algorithm through a blood flow rate function. The blood flow rate is proportional to the power required to maintain the temperature of the temperature sensor at a set number of degrees above the blood temperature.

[0025] These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the drawings and the following description, which more particularly describes specific embodiments of these concepts. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 A plan view of a catheter assembly according to some embodiments is provided.

[0027] Figure 2 A plan view of a catheter assembly according to some embodiments is provided.

[0028] Figure 3 A plan view of a catheter assembly according to some embodiments is provided.

[0029] Figures 4A-4C Various views of a catheter fixation device according to some embodiments are provided.

[0030] Figures 5A-5C Various views of a catheter fixation device according to some embodiments are provided.

[0031] Figure 6 A perspective view of a catheter assembly according to some embodiments is provided.

[0032] Figure 7 A partial cross-sectional view of a catheter assembly according to some embodiments is provided.

[0033] Figures 8A-8D Various views of an ultrasonic signal graph according to some embodiments are provided.

[0034] Figure 9A and Figure 9B Various views of a catheter assembly according to some embodiments are provided.

[0035] Figure 10 A partial cross-sectional view of a hub of a catheter assembly according to some embodiments is provided.

[0036] Figure 11 A view of a smart phone according to some embodiments is provided.

[0037] Figure 12 A perspective view of a catheter assembly and an auxiliary device according to some embodiments is provided.

[0038] Figure 13 A pressure map of a catheter assembly according to some embodiments is provided.

[0039] Figure 14 A partial cross-sectional view of a pressure-sensing syringe according to some embodiments is provided.

[0040] Figure 15 A partial cross-sectional view of a pressure-indicating catheter assembly according to some embodiments is provided.

[0041] Figure 16 A view of a distal portion of a catheter assembly according to some embodiments is provided.

[0042] Figure 17 A view of a distal portion of a catheter assembly according to some embodiments is provided.

[0043] Figure 18 A perspective view of a distal portion of a catheter assembly according to some embodiments is provided.

[0044] Figure 19 A perspective view of a Luer connector according to some embodiments is provided.

[0045] Figure 20 A perspective view of a Luer connector of a catheter assembly according to some embodiments is provided.

[0046] Figure 21 A perspective view of a double-forked socket of a catheter assembly according to some embodiments is provided.

[0047] Figure 22 A simplified view of a pump system for use with a catheter according to some embodiments is provided.

[0048] Figure 23 provided Figure 22 A side view of the pump unit of the illustrated pump system is provided.

[0049] Figure 24 A block diagram of a diagnostic system according to some embodiments is provided, the diagnostic system including a catheter assembly and a console configured for wired or wireless communication.

[0050] Figure 25 A diagnostic system configured for wired communication for use on a patient according to some embodiments is shown.

[0051] Figure 26 A diagnostic system configured for wireless communication for use on a patient according to some embodiments is shown. DETAILED DESCRIPTION

[0052] Before providing some specific embodiments in more detail, it should be understood that the specific embodiments provided herein do not limit the scope of the concepts disclosed herein. It should also be understood that the features of the specific embodiments disclosed herein can be easily separated from the specific embodiments and optionally combined with or substituted for the features of any one of the multiple other embodiments disclosed herein.

[0053] Regarding the terms used herein, it should also be understood that the terms are for the purpose of describing some specific embodiments, and the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or different steps in a group of features or a group of steps, and do not provide a sequence or numerical limitation. For example, the "first", "second", and "third" features or steps do not necessarily need to occur in that order, and specific embodiments including such features or steps do not necessarily need to be limited to these three features or steps. Labels such as "left", "right", "top", "bottom", "front", "rear", etc. are used for convenience and do not imply, for example, any specific fixed position, orientation, or direction. Instead, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms of "a", "an", and "the" include the plural forms unless the context clearly indicates otherwise.

[0054] For example, the "proximal", "proximal portion", or "proximal part" of a catheter disclosed herein includes the portion of the catheter that should be close to the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes a certain length of the catheter that should be close to the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes one end of the catheter that should be close to the clinician when the catheter is used on a patient. The proximal portion, proximal part, or proximal length of the catheter may include the proximal end of the catheter; however, the proximal portion, proximal part, or proximal length of the catheter does not need to include the proximal end of the catheter. That is, unless the context otherwise indicates, the proximal portion, proximal part, or proximal length of the catheter is not the terminal portion or terminal length of the catheter.

[0055] For example, the "distal", "distal portion", or "distal end portion" of the catheter disclosed herein includes the portion of the catheter that should be near or within the patient when the catheter is used in a patient. Similarly, for example, the "distal length" of the catheter includes the length of the catheter that should be near or within the patient when the catheter is used in a patient. For example, the "distal end" of the catheter includes one end of the catheter that should be near or within the patient when the catheter is used in a patient. The distal portion, distal end portion, or distal length of the catheter may include the distal end of the catheter; however, the distal portion, distal end portion, or distal length of the catheter need not include the distal end of the catheter. That is, unless the context otherwise indicates, the distal portion, distal end portion, or distal length of the catheter is not the terminal portion or terminal length of the catheter.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0057] Diagnostic systems and methods are disclosed herein, including temperature-sensing vascular devices for establishing a vascular or other access within a patient, such as catheter assemblies and needles. The vascular devices and complementary components such as fixation devices are first described, and then diagnostic systems including the vascular devices are described. Finally, methods of the diagnostic systems are described. Exemplary components, systems, and sensors can be found in U.S. Patent No. 10,433,790 and U.S. Publication No. 2019 / 0374162, the entire contents of which are incorporated herein by reference.

[0058] Vascular Devices and Complementary Components

[0059] A vascular access device includes a catheter assembly, cannula, needle, or other such medical device including an elongate tube configured for vascular insertion or placement. The catheter assembly may include a peripherally inserted central catheter ("PICC"), central venous catheter ("CVC"), arterial catheter, Foley-type urinary catheter, etc., peripheral intravenous ("IV") catheter, midline catheter, intermediate-dwell catheter, feeding tube, etc., some of which will be described in more detail below.

[0060] When the vasculature access device is a cannula, needle, or the like having an elongate conduit that defines at least one lumen extending between its proximal and distal ends, the elongate conduit may include one or more sensors that are capable of monitoring one or more physiological aspects or other parameters of the patient, or physical aspects of the vasculature access device itself or its operation when the vasculature access device is disposed within the patient. For example, the vasculature access device may include a single temperature sensor disposed within the distal portion of the elongate conduit and configured for temperature measurements therein. Additional details of the foregoing will be set forth hereinafter with respect to a catheter assembly type vasculature access device.

[0061] The catheter assembly is equipped with one or more sensors that are capable of monitoring one or more physiological aspects or other parameters of the patient, or physical aspects of the catheter assembly itself or its operation when the catheter assembly is disposed within the patient. These aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, and the like. The one or more sensors included in the catheter assembly are placed to be able to detect data related to these or other parameters. In some embodiments, the one or more sensors are disposed in or near the hub of the catheter assembly, although various other locations are possible. Additionally, other components and structures associated with the catheter assembly, such as a needleless connector, may include one or more sensors for monitoring physiological / physical aspects.

[0062] In addition, the catheter assembly includes the ability to wirelessly transmit or otherwise forward data related to the detected physiological / physical aspects to another location, which is also referred to herein as a receiving location. Examples of data receiving locations include a patient's electronic medical record (“EMR”), a patient monitoring device, a smartphone or other mobile device, a tablet, a storage location, a computer server, a nurse's station, or various other destinations.

[0063] Referring first to Figure 1 , which depicts various details of a catheter assembly (“catheter”) according to some embodiments, the catheter assembly being generally designated 10. As shown, catheter 10 includes an elongate catheter conduit 12 that defines one or more lumens 14 extending between a proximal end and a distal end 13 of the catheter conduit 12. The proximal end of the catheter conduit is operatively connected to a hub 16, which in turn is operatively connected to one or more extension legs 18 that extend the one or more lumens 14 through the remainder of one or more fluid channels of the catheter assembly 10. A connector 20, such as a Luer connector, is disposed at the proximal end of the extension legs 18. The hub 16 includes two suture wings 22 that extend relatively from the body of the hub 16. Each suture wing 22 includes a suture hole 24. Note that the hub 16 can be a bifurcated hub, a trifurcated hub, etc. depending on the number of fluid channels defined therethrough.

[0064] According to some embodiments, the catheter 10 includes one or more sensors, also referred to herein as a "sensor array" 30, to be able to detect data related to one or more physiological aspects of the patient or physical aspects of the catheter when the catheter conduit 12 is disposed in the vasculature (as described herein) or other suitable internal part of the patient's body. The catheter 10 may include multiple sensors, but the number, type, size, placement, function, and intended use of the various sensors may be different from those shown and described herein. Note that in some embodiments, the sensor array 30 may include only one sensor. Also note that in the case where only one of the specific sensors is discussed below, it should be understood that more than one sensor of a specific type may be included at the same or different locations within the catheter assembly.

[0065] As Figure 1 shown, a pressure sensor 32 is included as part of the sensor array 30. The pressure sensor 32 includes a central venous pressure ("CVP") sensor and is arranged such that it can sense the patient's venous pressure through a fluid (such as blood or saline) that is normally present within the lumen 14 of the catheter conduit 12. As shown in the figure, the pressure sensor 32 is disposed within the hub 16 so as to be operably in communication with a fluid passage 26 within the hub, which in turn is in fluid communication with Figure 1 the lumen 14 of the single-lumen catheter conduit 12 shown. Other pressure sensor locations may also be employed, including within the catheter conduit 12, within the extension leg 18, etc. In some embodiments, the pressure sensor 32 is a medical pressure sensor NPC-100 or NPC-120 manufactured by Amphenol Corporation, although other pressure sensors may also be used. In some other embodiments, the pressure sensor includes a strain-sensitive Wheatstone bridge. The sensing surface of the pressure sensor 32 may be in direct contact with the fluid present in the fluid passage of the hub 16. Note that the size, shape, and other configurations of the hub 16 may be increased from those shown and described herein to accommodate the sensor array 30.

[0066] The ECG sensor 34, also referred to herein as an ECG electrode or electrical sensor, is also included in the catheter assembly to enable detection of an ECG signal emanating from a patient's heart, along with additional ECG sensors / electrodes located on the patient's skin or external to / near the catheter assembly. As shown, the ECG sensor 34 can be disposed within the hub 16 to be in direct contact with the fluid present in the hub fluid passage 26 and the lumen 14 of the catheter conduit 12. Other ECG sensor locations can also be employed, including within the catheter conduit 12, within the extension leg 18, etc. The ECG sensor 34 includes a lead wire that is capable of detecting the ECG signal of the patient's heart present in the fluid within the hub fluid passage 26 and the catheter conduit lumen 14, although other types of ECG sensors can also be employed. More details regarding systems and methods for using an ECG sensor to guide a catheter assembly to a desired location within a patient can be found in U.S. Patent No. 8,849,382, entitled "Apparatus and Display Methods Relating to Intravascular Placement of a Catheter", the entire contents of which are incorporated herein by reference.

[0067] As described above, the sensor array 30 (including herein the pressure sensor 32 and the ECG sensor 34) is disposed within the hub 16, and the hub is sized to provide the required volume for these sensors. Note that the size, shape, and configuration of the hub 16 can be different from those shown and described to accommodate the one or more sensors. The sensors can be located in other parts of the catheter 10, including along the catheter conduit 12, within the extension leg 18, etc. or at either end thereof. It should also be noted that the catheter assembly can include various sensors for detecting body measurements, patient physiology, or physical aspects of the catheter, some of which will be discussed further below.

[0068] Figure 1 Further shown is that the hub 16 (or other suitable location) includes a printed circuit board ("PCB") 36 that is configured to control the operation of the sensor array 30, including herein the pressure sensor 32 and the ECG sensor 34. The PCB 36 can include a microprocessor for controlling the operation of the sensors. The PCB 36 can further include a power source for powering the sensor array 30, although in some embodiments, the power source can be remote from the PCB and even remote from the catheter 10. Non-volatile memory storage locations, such as flash memory, can also be included on the PCB 36 to enable data sensed by the sensors of the sensor array 30 to be stored thereon temporarily or permanently. The storage locations can be accessed by a user or can be transmitted to a desired location in the manner described below.

[0069] The PCB 36 may further include a transmission module, such as a radio, to enable the PCB 36 to wirelessly transmit sensor data to another receiving location, such as those further mentioned above. Such wireless transmission may be performed via Bluetooth, Wi-Fi, radio frequency, near field communication (“NFC”), GPS, ANT, ZigBee, or other means utilizing electromagnetic radiation. The sensor data may be transmitted from the conduit 10 via a physical connection, such as a removable physical connection, wires, etc. As described above, sensor data, such as central venous pressure, ECG signal, temperature, etc., is stored at a storage location on the PCB 36 or at other locations on the conduit 10. The PCB 36 may include a clock or timer circuit.

[0070] As Figure 1 shown, the suture holes 24 of the suture wings 22 are configured to include electrical contacts to supply power to the sensors 30 and 34 of the sensor array 30 and the PCB 36. In particular, annular electrical contacts 40 are included in each suture hole 24 of the hub suture wings 22, and the electrical contacts are operably connected to the PCB 36 and the sensor array 30. A fixing device, such as Figures 4A-4C the fixing device 50 shown, is configured to be placed on the skin of a patient, operably connected to the conduit 10 and fixed in place once the distal portion of the conduit has been inserted into the patient. To this end, the fixing device 50 includes a holder 54 mounted on an adhesive pad, and a hinged fixing arm to pivot removably (in a snap-fit arrangement) on top of the suture wings 22 of the hub 16 so as to fix the hub in place.

[0071] The fixing device 50 may include additional functionality to supply power to the sensor array 30 and the PCB 36. Specifically, the fixing device 50 includes two posts 58, each configured to serve as an electrical contact 60, and each post is operably connected to a battery 62, which is also included in the fixing device. The posts 58 are configured to be received within corresponding suture holes 24 of the conduit suture wings 22 such that electrical contact is established with the electrical contacts 40 of the suture holes. In this way, the battery 62 included in the fixing device 50 may supply power to the sensors 32, 34 and the PCB 36 of the conduit hub 16. Of course, other external power sources may also be used. In some embodiments, the electrical contacts between the conduit and the fixing device may also be used to transmit sensor data therebetween. In some other embodiments, the fixing device may include a radio or other mode for transmitting the sensor data received from the conduit. In other embodiments, the PCB or the sensor may be included on the fixing device. It should be understood that the size, shape and other configurations of the fixing device may be different from those shown and described herein.

[0072] Figures 5A-5CDepicts details of the fixture 50 according to some embodiments, where the fixture includes a pod 70 that includes, for example, a PCB and a battery for use with a sensor array 30 included on the catheter 10. This eliminates the need to dispose the PCB or the battery on the catheter 10 itself. Figure 5A and Figure 5C Shows that the pod 70 includes electrical contacts 60 on the upper surface of the holder 54, where it is configured to be electrically connected to corresponding electrical contacts on the socket 16 of the catheter 10. Thus, when the socket 16 is removably held by the fixing arm 56 of the fixture 50, the sensor array 30 is powered and controlled by the PCB and the battery of the pod 70. The pod 70 can be configured to be removable from the fixture 50, enabling it to be reused with a subsequent fixture. This can be helpful when replacing the catheter 10 or the fixture 50. Thus, the pod 70 (including the PCB, the battery, or one or more sensors, etc.) can be removed from the fixture and placed into another fixture, thus saving resources and costs. Note that the battery and the PCB can also be placed in other locations. Thus, these and other variations are expected. Further details regarding the catheter fixture related to the present disclosure can be found in U.S. Patent No. 6,770,055 titled "Universal Catheter Anchoring System", the entire content of which is incorporated herein by reference.

[0073] In addition, in some embodiments, the fixture 50 can include an ECG sensor (e.g., electrodes) that can cooperate with the ECG sensor 34 of the catheter 10, enabling the detection of a dual ECG signal and its use for determining the proximity of the distal end 13 of the catheter lumen 12 to the heart. This configuration can also be used to determine the misalignment of the distal end 13 of the catheter lumen during the initial catheter lumen placement and during subsequent catheter retention within the patient. The sensor data from the pressure sensor 30 can also be used in combination with the ECG signal to further detect the misalignment of the distal end of the catheter lumen.

[0074] Figure 2 and Figure 3 respectively show dual-lumen and triple-lumen catheter configurations, in contrast to Figure 1 the single-lumen configuration of Figure 1 . Similar to Figure 2 and Figure 3 , the catheters 10 shown both include a sensor array 30 similar to Figure 1 shown, including corresponding pressure sensors 32, ECG sensors 34, and PCBs 36. Electrical contacts 40 for electrical connection to the electrical contacts 60 of the fixture 50 are also shown ( Figures 4A-4C ). Note that Figure 2 and Figure 3Each extension leg 18 of the catheter 10 therein includes a respective one of the pressure sensors 32 such that pressure data can be sensed in each extension leg. More or fewer sensors than Figure 2 and Figure 3 shown therein can be used to sense physiological aspects of a patient or physical aspects of the catheter assembly, including, for example, lactate sensors, oxygen sensors, ultrasonic components, GPS position sensors, temperature sensors, dimensional sensors for measuring the inner diameter of a lumen, fluid velocity sensors, glucose meters, oxygen sensors, lactate sensors, cardiac output sensors, accelerometers, blood volume and cardiac output sensors, and the like.

[0075] Figure 6 FIG. 5 depicts the catheter 10 including three pressure sensors 30 located at specific positions in respective extension legs 18 and an ECG sensor 34 disposed in one extension leg, each sensor being operatively connected to a PCB 36 disposed in the hub 16. Thus, FIG. 5 shows that the number, type, and placement of the one or more sensors and the PCB can be different from those already shown and described.

[0076] Figure 7 FIG. 12 depicts details of the sensor-equipped catheter 10 according to some embodiments, where the hub 16 includes an ultrasonic assembly 80 that includes an upper PCB 82A and a lower PCB 82B configured to control ultrasonic transducers 84A and 84B, respectively. As Figures 8A-8D shown, the ultrasonic transducers 84A and 84B can be used to ultrasonically evaluate the fluid passage 26 of the hub 16 to determine the contents of the lumen. For example, Figure 8A FIG. 16 shows that when air is present in the fluid passage 26, no ultrasonic signal exists, as shown by the ultrasonic signal graph 90 of Figure 8A FIG. 18. In contrast, when a fluid such as Fluid A is present in the fluid passage 26, the ultrasonic transducers 84A and 84B return a signal of a specific voltage consistent with the composition of Fluid A, as shown by the graph 90 of Figure 8B FIG. 20. If a fluid B different in composition from Fluid A is present in the fluid passage 26, the ultrasonic transducers 84A and 84B return a specific voltage signal consistent with the composition of Fluid B, as shown by the graph 90 of Figure 8C FIG. 21. And when both fluid and air are present in the fluid passage 26, Figure 8D the graph 90 of FIG. 24 shows a varying voltage signal detected by the ultrasonic transducers 84A and 84B. Thus, the ultrasonic transducers 84A and 84B, coupled to a battery and a PCB as further discussed above, can assist a user in determining the presence of a particular substance in the fluid passage 26 of the hub 16 or the lumen of other catheter components based on the placement of the ultrasonic transducers. In some other embodiments, only a single ultrasonic transducer is used.

[0077] Figure 9A and Figure 9B depicts details of a sensor-equipped catheter 10 according to some embodiments, where the hub 16 includes a PCB 82 disposed therein, the PCB being operably connected to a temperature sensor 100, such as a thermocouple, the temperature sensor being positioned to measure core body temperature via blood or other fluid present in the lumen 14 of the catheter. As Figure 9B shown, the temperature sensor 100 can be placed near the lumen 14 through a longitudinal incision or cavity 108 defined in the catheter conduit 12 or hub 16. Potting 106 can optionally be used to fill the cavity 108 around the temperature sensor 100. If the temperature sensor 100 (e.g., a thermistor) is configured to contact the infusion, the temperature sensor 100 can be used to measure its flow rate, as described herein for blood flow rate. When used in combination with the pressure determination device disclosed herein, occlusions can be detected more precisely. In some embodiments, the temperature sensor 100 includes a Type 401 thermistor of the 400 series available from Cole-Palmer Inc., Vernon Hills, IL.

[0078] Figure 10 illustrates that various sensors can be included within the hub 16 or other suitable locations as part of a sensor array 30. As Figure 10 shown, the hub 16 can include a pressure sensor 32, a PCB 36 (including a processor 36A and a wireless communication module 36B), upper and lower ultrasonic transducers 84A and 84B, a temperature sensor 100, and an oxygen sensor 110 disposed therein. The various sensors are arranged as needed near the fluid passage 26 of the hub 16 to sense relevant parameters detected in the fluid present in the fluid passage. The specific arrangement of the sensors can be different from that shown here.

[0079] Figure 11Illustrated is that the smart phone 120 can be a receiving location for wirelessly receiving data from one or more sensors of a sensor array, as discussed in some of the above embodiments. Examples of wireless modes in which data can be transmitted include Bluetooth, Wi-Fi, radio frequency, near field communication (NFC), ANT, ZigBee, etc. Such data transmission can be relayed by a software-based application or other intermediate device. This enables a clinician to receive mobile updates and other sensor data 124 from the catheter 10 via the display screen 122 of the smart phone 120 (or via other media including sound, vibration, etc.) in order to be able to monitor a patient's progress or condition. As described above, other locations for receiving sensor data include a patient electronic medical record (“EPR”), a patient monitoring device, other mobile devices including electronic tablets and laptop computers, an electronic storage location, a computer server, a nurse's station, medical equipment such as a pump attached to the catheter, and various other destinations. It should be understood that the devices, components, computers, etc. located at the receiving location can perform operations on the received data, including analysis, trending, alarm functions, etc.

[0080] Figure 12 Depicted is a catheter 10 according to some embodiments, where the catheter is shown inserted into a patient's arm 128 such that most of the catheter conduit 12 is disposed within the patient's vasculature. Also shown is a hub 16 including one or more sensors operatively connected to an auxiliary device, such as an armband 130, which is placed around the patient's arm 128 via a connecting line 134. In some embodiments, the armband 130 is placed near the outside of the catheter 10, although in other embodiments its position and specific shape, size, configuration, and body attachment scheme can vary. As shown, the armband 130 includes various components that work in concert with the one or more sensors of the catheter 10 via the connecting line 134, including a PCB 36 and a wireless communication module 136 (in other embodiments, it is included in the PCB). Sensor data detected by the one or more sensors of the catheter 10 can be forwarded from the catheter 10 to the components of the armband 130 via the connecting line 134, where the data can be processed (e.g., by the PCB 36) or transmitted to a remote location (e.g., via the wireless communication module 136). In some other embodiments, the operative connection between the catheter 10 and the armband 130 is also a wireless connection.

[0081] Placing the PCB 36 and the wireless communication module 136 on the armband 130 frees up space on the catheter and can prevent the need to replace relatively expensive components when the catheter 10 itself is regularly replaced with a new catheter. In such a case, the armband 130 can simply be connected to the new catheter, and the PCB 36 and the wireless communication module 136 can begin working with the new catheter just as they did with the previous catheter. Note that the armband 130 can also include various other components, including a battery for powering the one or more sensors included on the catheter, additional sensors including an ECG sensor, etc. As described above, the armband 130 represents other wearable and non-wearable auxiliary devices that can be operatively connected to the one or more sensors of the catheter 10 to facilitate their operation. Also note that the components on the armband / auxiliary device can be replaceable / reusable. In some embodiments, the PCB, battery, or wireless communication module can be included on the catheter fixation device. In some other embodiments, the above components can be included on a platform removably attached to the armband. In some other embodiments, the armband or similar component includes a disposable cover to isolate it from the patient or provide isolation from contaminants.

[0082] Several of the above embodiments include a pressure sensor 32 configured to sense data related to the central venous pressure of a patient in which the catheter 10 is disposed. In some other embodiments, the data sensed by the pressure sensor 32 can further be used to detect when an occlusion, such as a fibrin sheath or a blood clot, may be present in the lumen 14 of the catheter conduit 12. Figure 13 A pressure graph 140 including a pressure curve 142 is shown, which depicts the change in the pressure level in the lumen 14 of the catheter conduit sensed by the pressure sensor 32 over time, e.g., in Figure 10 the pressure sensor configuration where, during a flushing process, for example, the user uses a syringe connected to the Luer connector 20 to flush fluid through the catheter 10 to maintain the patency of the lumen 14 of the catheter conduit. As shown, the pressure curve 142 includes various pressure peaks 144, which are caused by the user applying a pulse to the syringe at the moment of additional pressure. This is done to clear any minor obstructions that may have formed within the lumen 14 of the catheter conduit or other areas of the catheter conduit fluid path. When an occlusion is present in the distal end 13 or the lumen 14 of the catheter conduit (e.g., see Figure 15 the occlusion 178 in), the pressure curve 142 will increase (i.e., move vertically upward along the pressure y-axis) or widen (i.e., become longer along the time x-axis).

[0083] More specifically, the hydraulic resistance R of a fluid is generally related to the fluid flow rate Q and the infusion pressure P by the following relationship:

[0084] P = Q * R, (1)

[0085] This gives:

[0086] R = ∫[t1 to t2] P dt / V, (2)

[0087] where V is the known volume of fluid to be infused into the catheter 10, t1 is the time at the start of the fluid infusion process, and t2 is the time at the end of the fluid infusion process (see Figure 13 ), note that P represents the instantaneous pressure at each moment of the fluid infusion process. Compare the resistance R of the fluid infusion through the catheter lumen 12 over a certain period of time (using the above equation) with the previous resistance R0. For example, when the catheter 10 is first inserted into the patient's body and is considered unoccluded or patent, the percentage of possible occlusion in the catheter lumen can be obtained according to the following equation:

[0088] % occlusion = R / R0 (3)

[0089] The detection by the pressure sensor 32 of the elevated pressure within the catheter fluid path, for example through the above calculations, can warn the user of a possible occlusion, enabling corrective measures to be taken. Additionally, data stored at a storage location on the catheter 10 with the PCB 36 or remotely in the patient's electronic medical record (or other remote storage location) can be used to measure the change in catheter flush pressure over time in order to detect the change in pressure over time. It will be understood that data comparison over time can be performed on any one of the sensors located on the catheter 10. Of course, the data sensed by the sensors and stored at the storage location can also be used for various other purposes, including historical trends and the like.

[0090] Figure 14 Depicts various details of the pressure-sensing syringe 150, which includes a housing 152 that defines a cavity 154 having a distal fluid outlet 156. A plunger 158 is disposed within the cavity 154 and is attached to a spring 160 that is initially set in a compressed state and can be released by a release button 162 disposed at the proximal end of the syringe 150. A known amount of 0.9% saline 164 or other suitable liquid is placed within the cavity distal to the plunger 158 such that when the spring 160 is actuated by the release button 162, the saline flows out of the fluid outlet 156. When the syringe is operatively attached to the corresponding Luer connector 20, the saline 164 discharged from the syringe 150 is injected into the extension leg 18 and then through the lumen 14 of the cannula 16 and the catheter lumen.

[0091] A pressure sensor 166 is included at the fluid outlet 156 to measure the pressure of a known quantity of brine 164 as it leaves the fluid outlet 156 and enters the catheter 10 connected to the syringe 150. A processor unit 170 and a display / control unit 172 are included to measure and calculate (e.g., via the equations further described above) the pressure present when the plunger 158 expels brine 164 through the fluid outlet 156. The processor unit 170 may perform further calculations to determine the hydraulic resistance of the injection, and thereby obtain the amount of occlusion present in the fluid path of the catheter 10 using the known volume of the injected brine 164, the injection pressure measured by the pressure sensor 166, and the amount of time required to inject all of the brine. In some embodiments, the user may input the dimensions and length of the catheter lumen 14 of the catheter tubing via the display / control unit 172.

[0092] Results describing any amount of occlusion present in the catheter fluid path (e.g., expressed as a percentage of the occluded fluid path) may be depicted on the display / control unit 172 or wirelessly transmitted, for example, via a wireless communication module included in the processor unit 170 to a receiving location. If desired, the user may take corrective action.

[0093] Note that historical pressure / occlusion data may be stored by a storage location of the processor unit 170, e.g., for invocation and depiction by the display / control unit 172. In some embodiments, the plunger 158 of the syringe 150 may be manually depressed by the user, and thus a spring 160 is not required, or it may be a pressurized gas source that pushes the plunger, etc. The location of the pressure sensor 166 may also be different from that shown and described herein.

[0094] Note that in some other embodiments, a pressure sensor 32 may be used to determine when the catheter tubing 12 has become misaligned within the vasculature by sensing the pressure difference between an expected value for correct placement and the actual sensed value detected by the pressure sensor. When this occurs, appropriate steps may be taken to correct the misalignment. In some other embodiments, the pressure sensor 32 and an electrocardiogram (ECG) sensor 34 may work in concert to detect catheter misalignment based on venous pressure readings and ECG signal analysis.

[0095] Figure 15 Various details of the catheter 10 are depicted, which include the ability to detect occlusion, such as a partial occlusion 178 shown at the distal end 13 of the catheter tubing 12. As shown, the catheter 10 includes a pressure detection module 180 operably attached to a Luer connector 20 of the catheter 10. A syringe 182 is attached to the proximal end of the pressure detection module 180 to provide an injection of brine or other suitable fluid through a flow lumen 184 of the pressure detection module 180 and into an extension leg 18 to flow through the catheter 10.

[0096] As shown, pressure detection module 180 includes a pressure indicator 188 in fluid communication with flow lumen 184. The pressure indicator 188 is configured to cause an indicator member to extend outwardly when a predetermined pressure is encountered in flow lumen 184 of the pressure detection module. Thus, when fluid is injected into the system through syringe 182 (or other suitable fluid injection device), and a fluid pressure exceeding the predetermined pressure is encountered in catheter lumen 14, the pressure buildup extends proximally through pedestal 16, extension leg 18, and flow lumen 184, causing the indicator member of the pressure indicator to extend outwardly, thereby indicating to the user that an occlusion may be present. It should be understood that indicator members of different configurations may be employed. The pressure detection module 180 may be a separate component attachable to catheter 10; in some other embodiments, the pressure detection module is integrally formed with the catheter.

[0097] Figure 16 Depicts possible locations of sensors of sensor array 30 within catheter conduit 12. As shown, various sensors 200 of sensor array 30 are disposed proximal to distal end 13 of catheter conduit 12, and pressure sensor 32 is disposed proximal to the other sensors. Figure 16 Further shown is that connection line 192 extends along a central portion of the catheter conduit, such as within a septum separating lumens 14 from each other, to power sensors 200 of sensor array 30. In some other embodiments, connection line 192 may be disposed within a dedicated lumen extending the length of the catheter conduit. Note that the one or more sensors are placed a certain distance proximal to distal end 13 of the catheter conduit, such as pressure sensor 32 here, such that catheter conduit 12 can be trimmed distally.

[0098] Figure 17 Depicts another configuration for including sensor 202 within catheter conduit 12, where sensor 202 is disposed within a longitudinally defined cutout 198 in the wall of catheter conduit 12. Encapsulation 204, such as a thermally conductive epoxy, polyurethane, or RTV encapsulation, is included to cover sensor 202. In some embodiments, sensor 202 includes a glucose sensor for sensing blood glucose levels and is not encapsulated such that the glucose sensor is in direct contact with blood. Thus, these and other possible sensor locations are contemplated.

[0099] Figure 18Depicts another configuration for including a sensor in the catheter lumen 12, where the sensor 202 is disposed on the inner surface of one of the lumens 14 of the catheter lumen 12, proximal to the distal end 13 of the catheter lumen 12, or disposed within a septum that divides the lumen space within the catheter lumen 12 into two or more lumens 14. An encapsulation 204 may be included to insulate and cover the sensor 202 as needed. In some embodiments, the encapsulation 204 protects the sensor 202 from exposure to liquids while allowing heat to be transferred therethrough. Figure 18 Further shown is that wire-based electrodes 210 may be disposed within the wall of the catheter lumen 12, proximal to the distal end 13 of the catheter lumen 12, such that they are exposed on its outer surface. The electrodes 210 may be formed as concentrically arranged sensors, which may be used to perform volume measurements to determine the size of the blood vessel in which the catheter lumen is disposed, thereby assisting the user in determining a possible misalignment of the catheter lumen within an undesired blood vessel. Thus, these and other possible sensor configurations are contemplated.

[0100] Figure 19 Depicts various details of a flush sensor 222 for detecting when a desired periodic flush of the catheter 10 with fluid has occurred, also referred to herein as the flush state of the catheter lumen 12. As shown, the flush sensor 222 is disposed within the cavity 220 of the Luer connector 20 of the catheter extension leg 18, although other locations may also be used for the sensor, such as within the hub 16, where the flush sensor 222 is optionally a thermistor. As shown, the flush sensor 222, also referred to herein as the detection module, includes a lever 224 biased to a protruding position by a spring 226. The flush sensor 222 is operatively connected to a processor or other suitable component (e.g., disposed within the Luer connector 20) of a PCB (such as Figure 10 the PCB 36 shown) to control its operation and process the sensed data.

[0101] In operation, when a syringe or other component is inserted into the cavity 220 of the Luer connector 20 to flush the catheter 10 with saline or other suitable fluid, the lever 224 of the flush sensor 222 is depressed, which causes a signal to be sent to the processor indicating that the flushing process is occurring. The flush time or other data related to the flushing procedure may be recorded, stored, or used by the processor, or wirelessly transmitted to a receiving location in a manner similar to that further discussed above. In some embodiments, the flush sensor 222 and the processor of the PCB 36 are referred to as a flush sensor assembly, but it should be understood that the assembly may include additional components. In some other embodiments, an electrical sensor may be used as the flush sensor, where the electrical sensor includes a circuit that is broken whenever a component is inserted into the connector 20. The breaking of the circuit resets a timer circuit to measure the next cycle until the flush sensor is activated again.

[0102] For example, in some embodiments, it is desirable to flush the catheter 10 at least once every 12 hours. When the flush sensor 222 detects a flush procedure as described above, the timer circuit in the processor is reset to start timing to measure the next time period until the flush sensor 222 is pressed again to indicate a new flush procedure.

[0103] Figure 20 It is shown that a light array 230 (e.g., a collection of red LED lights, yellow LED lights, and green LED lights) can be included on the surface of the Luer connector 20 to visually indicate the flush status of the catheter 10: a green light indicates that less than 10 hours have passed since the last detected flush procedure; a yellow light indicates that more than 10 hours but less than 12 hours have passed since the last flush procedure; a red light indicates that more than 12 hours have passed since the last flush procedure. The processor controls the operation of the light array, and it should be understood that the lights can vary in number, size, location, purpose, elapsed time indicated, etc. In addition, it should be understood that other types of sensors, including sensors that detect the presence of liquid within the Luer connector cavity 220, can also be used to detect the flushing process.

[0104] In some other embodiments, the light array 230 can be used as follows: after an acceptable flush procedure has been performed, the green light blinks; after an unacceptable or incomplete flush procedure occurs, the red light blinks; the yellow light blinks or turns on to indicate a possible occlusion in the catheter conduit 12. In some other embodiments, the yellow light (or other light) can be illuminated to alert to flush the catheter 10.

[0105] It should be understood that in some other embodiments, the Luer connector 20 or other parts of the catheter 10 can include a button (or other user-activated component) that can be pressed during catheter flushing to reset the timer circuit. In this case, a counting circuit can also be included to count the number of times the connector 20 or other components are accessed.

[0106] Figure 21 It is shown that the light array 230 can be set at other locations on the catheter 10, including on the hub 16. Thus, these and other possible locations can be considered, such as the catheter conduit or extension leg, or, for example Figure 12 the armband 130. In some other embodiments, the light array can be used to warn the user of other sensed conditions, including elevated body temperature / fever, onset of sepsis (see below), catheter occlusion, low oxygen levels, etc. In addition, in addition to lights, other indicators can be used to alert the user about sensor data, including sounds, vibrations, etc., either on the catheter itself or at a remote receiving location that wirelessly transmits data.

[0107] Note that the flush sensor 222 may also be included in other areas, such as including a needleless connector configured to be operably attached to a luer connector.

[0108] In some embodiments, the pressure sensor 32 can be used alone or in combination with the above-described flush sensor 222 to detect or characterize the flushing process. For example, the flush sensor 222 can be used to detect the flushing process, while the pressure sensor 32 can sense the amount of pressure present during the flushing process to detect a possible occlusion. In fact, in some embodiments, the pressure sensor 32 can be used to determine the flushing frequency, flushing technique, flushing time, number of catheter insertions, time elapsed since the last catheter insertion, etc. of the catheter 10, e.g., by using a timer circuit included on the PCB 36 to measure the pressure within the lumen 14 of the catheter over time. As described above, such sensor data can be stored at a storage location, e.g., located on the PCB 36, or transmitted to another local or remote receiving location. The processing to determine such monitoring can be performed by a processor included on the PCB 36 or remotely.

[0109] In some embodiments, sensor data from catheter sensors (e.g., pressure sensor 32 and core body temperature sensor) can be used to detect patient conditions, such as sepsis. In particular, blood flow rate, respiratory rate, heart rate, and body temperature can be sensed by the pressure sensor 32 and the core body temperature sensor 100 included in the catheter 10, e.g., in the Figure 10 configuration shown. These three parameters include three of the four parameters commonly used to determine the onset of sepsis. Thus, monitoring these parameters via the catheter 10 as described herein can be used to prevent, detect, and improve the complications of sepsis.

[0110] Figure 22 Depicted is a sensor-based catheter assembly according to some embodiments. Specifically, the catheter 10 is shown with its catheter lumen 12 disposed within a patient's vasculature, and two luer connectors 20 are operably connected to a supply line 240 configured to provide fluid to and remove fluid from the lumen of the catheter lumen. A pump unit 250 is included to enable fluid movement through the supply line 240. If desired or needed, a saline drip assembly 252 is also included to provide fluid to the pump unit for movement through the supply line. A syringe, such as syringe 182, is included to provide an additional fluid inlet in a respective one of the supply lines 240.

[0111] Figure 23 Depicted is Figure 22 further details of the pump unit 250, including a fluid inlet 256A and a fluid outlet 256B, which are configured to be operably associated with respective supply lines 240 ( Figure 22) are connected to bring blood or other fluids from within the patient's vasculature to the pump unit 250 via the catheter 10 (via the fluid inlet 256A) and return the fluid to the patient's vasculature via the catheter (via the fluid outlet 256B). The pump unit 250 includes a pump 258 to cause the movement of the fluid. Additionally, the pump unit 250 includes various input ports 260 that are in fluid communication with the fluid inlet 256A to enable the input of additional fluids, including heparin, saline, arterial input, etc.

[0112] One or more sensors 262 are also included in the pump unit 250 and are arranged to measure one or more physiological aspects of the patient's blood. Examples of such sensors include blood glucose meters, oxygen sensors, lactate sensors, cardiac output sensors, etc. The location of the sensors 262 can be different from that shown here. Setting the sensors 262 in the pump unit 250 rather than on the catheter 10 itself enables the use of relatively large-sized sensors without overly increasing the size of the catheter.

[0113] Diagnostic system

[0114] Figure 24 A block diagram of a diagnostic system 2400 according to some embodiments is provided, the diagnostic system including a catheter assembly 10 and a console 2402 configured for wired or wireless communication. Figure 25 and Figure 26 Illustrated is a diagnostic system 2400 being used on a patient, where Figure 25 the diagnostic system is configured for wired communication, while Figure 26 the diagnostic system is configured for wireless communication.

[0115] As shown, the diagnostic system 2400 includes a catheter assembly 10, a console 2402, and a display screen 2414, where the catheter assembly 10 is a disposable device and the console 2402 and the display screen 2414 are capital equipment for multiple uses. Although the display screen 2414 can be an integrated display screen integrated into the console 2402 as shown, the display screen 2414 can also be a separate display screen of a monitor compatible with the diagnostic system 2400 or its console 2402. In any case, the display screen 2414 is configured to communicate with the console 2402 and display a GUI thereon, the GUI including at least temperature readings associated with one or more sensors 30 of the catheter assembly 10 while the catheter conduit 12 is disposed in the patient's vasculature.

[0116] It should be understood that the catheter assembly 10 is an example of a vascular access device that can be used in a diagnostic system 2400 having a console 2402 and a display screen 2414. In fact, the vascular access device can be changed to a cannula or a needle. Therefore, the disclosure regarding the catheter assembly 10 should be understood to include other vascular access devices, such as the aforementioned cannula or needle, unless the disclosure specifically pertains to the features of the catheter assembly 10.

[0117] As described above, the catheter assembly 10 includes a catheter tube 12, a hub 16 operably attached to the catheter tube 12, one or more extension legs 18 operably attached to the hub 16 and commensurate with a plurality of lumens or fluid channels of the catheter assembly 10, and one or more sensors 30, such as a single temperature sensor (e.g., Figure 9A the temperature sensor 100 in Figure 24 or 9B) or multiple temperature sensors (e.g., the temperature sensors 100a, 100b,..., 100n shown in

[0118] If the vascular access device is a cannula or a needle, the cannula or the needle may include the aforementioned one or more sensors 30. For example, such a vascular access device may have a single temperature sensor disposed within the distal portion of its elongate tube, the temperature sensor being configured for temperature measurement therein when disposed within a patient's vascular system.

[0119] As Figure 1 shown, the catheter tube 12 defines at least one lumen extending between a proximal end and a distal end 13 of the catheter tube 12. Together with at least one lumen of the hub 16 and at least one lumen of the extension legs 18, the at least one lumen of the catheter tube 12 defines at least one fluid channel through the catheter assembly 12. The catheter assembly 10 can be a single-lumen catheter assembly 10, such as Figure 1 the single-lumen catheter assembly 10 having only the aforementioned fluid channel. Alternatively, the catheter assembly 10 can be a multi-lumen catheter assembly, such as Figure 2 the double-lumen catheter assembly 10 having two fluid channels through the catheter assembly 10, or Figure 3 the triple-lumen catheter assembly 10 having three fluid channels through the catheter assembly 10.

[0120] The one or more sensors 30 may include a single temperature sensor (e.g., Figure 9A or Figure 9B the temperature sensor 100 in Figure 24 or multiple temperature sensors (e.g., the temperature sensors 100a, 100b,..., 100n shown in

[0121] When the catheter assembly 10 has a single temperature sensor 100, the single temperature sensor 100 can be disposed within the catheter lumen 12, the hub 16, or the extension leg 18 for temperature measurement therein. For example, as described above with respect to Figure 9A , Figure 9B or Figure 17 of the catheter assembly 10, the single temperature sensor 100 can be disposed within the wall of the catheter lumen 12. Optionally, the single temperature sensor 100 can be disposed on or within the septum of the catheter lumen 12, as described above with respect to Figure 18 of the catheter assembly 10. As needed, electrical leads for connecting the single temperature sensor 100 to a power source (e.g., the fixture 50 or the console 2402) can be disposed within the wall of the catheter lumen 12, within the septum of the catheter lumen 12, or within both the wall and the septum of the catheter lumen 12.

[0122] When the catheter assembly 10 has multiple temperature sensors 100a, 100b, …, 100n, the multiple temperature sensors 100a, 100b, …, 100n can be disposed within the catheter lumen 12, the hub 16, the extension leg 18, or a combination thereof, and are configured for temperature measurement therein. For example, the catheter lumen 12 can include at least one temperature sensor disposed within the catheter lumen 12 for temperature measurement within the catheter lumen 12, the hub 16 can include at least one temperature sensor disposed within the hub 16 for temperature measurement within the hub 16, or each component of the catheter assembly 50 of the catheter lumen 12 and the hub 16 can include at least one temperature sensor disposed therein for temperature measurement.

[0123] As described above with respect to Figure 9A , Figure 9B or Figure 17 of the catheter assembly 10, a temperature sensor, such as any of the multiple temperature sensors 100a, 100b, …, 100n, can be disposed within the wall of the catheter lumen 12. Alternatively, a temperature sensor, such as any of the multiple temperature sensors 100a, 100b, …, 100n, can be disposed on or within the septum of the catheter lumen 12, as described above with respect to Figure 18described for the catheter assembly 10. A combination of a plurality of temperature sensors 100a, 100b, …, 100n within the wall of the catheter lumen 12 and one or more diaphragms of the catheter lumen 12 is also possible. Whether the plurality of temperature sensors 100a, 100b, …, 100n are disposed within the wall of the catheter lumen 12, on or within a diaphragm of the catheter lumen 12, or a combination thereof, the plurality of temperature sensors 100a, 100b, …, 100n may be intermittently disposed along the length of the catheter lumen 12. Disposing each of the plurality of temperature sensors 100a, 100b, …, 100n at different ones of a plurality of positions along the length of the catheter lumen 12 is useful for measuring local temperatures at different positions. Optionally, electrical leads for connecting the plurality of temperature sensors 100a, 100b, …, 100n to a power source such as the fixture 50 or the console 2402 may be disposed within the wall of the catheter lumen 12, within a diaphragm of the catheter lumen 12, or within both the wall of the catheter lumen 12 and a diaphragm of the catheter lumen 12.

[0124] The console 2402 includes a memory 2406, such as a main memory 2408 and a secondary memory 2410. The main memory 2408 includes a random access memory (“RAM”). The secondary memory 2410 includes non-volatile memory, such as a read only memory (“ROM”), having instructions 2412 for loading into the main memory 2408 when the console 2402 is operating, for instantiating a diagnostic process of the console 2402, the diagnostic process having one or more functions for at least processing temperature data from one or more sensors 30 when the catheter lumen 12 is placed within a patient's vasculature. (For examples of catheter lumens 12 placed within a patient's vasculature, see Figure 25 and Figure 26 .) The instructions 2412 may include instructions for the diagnostic process, one or more functions of the diagnostic process, one or more algorithms for processing temperature data, or a combination thereof. The instructions 2412 may also be used to instantiate a display server configured to coordinate inputs to and outputs from the console 2402. Inputs to the console 2402 include selection of the one or more functions of the diagnostic process, such as via a GUI on the display screen 2414. Outputs from the console 2402 include the GUI on the display screen 2414.

[0125] The console 2402 is configured to communicate with the catheter assembly 10 and the display screen 2414 and to power the catheter assembly 10 when the fixture 50 is not in use. Such communication and power options are described in Figures 24-26is shown. For example, the catheter assembly 10 may have a wired connection to the console 2402 through the connector 2416, where the wired connection allows power to be provided from the console 2402 to the catheter assembly 10 and data (e.g., temperature data) to be provided from the catheter assembly 10 to the console 2402. (See Figure 24 , connection, option A.) In another example, the catheter assembly 10 may have a wireless communication module configured to provide data (e.g., temperature data) to the wireless communication module of the console 2402. Similarly, in embodiments using wireless communication to transmit data, power may be supplied to the catheter assembly 10 by the fixture 50. (See Figure 24 , connection, option B.)

[0126] One or more algorithms for processing temperature data are useful for processing temperature data from any temperature sensors of the catheter assembly 50 during a diagnostic procedure when the catheter tube 12 is placed in a patient's vasculature. For example, one or more temperature data processing algorithms may include an infection diagnosis algorithm for diagnosing an infection in a patient's vasculature or subcutaneous tissue. (Other temperature data processing algorithms will be elaborated below for certain functions of the diagnostic procedure.) When the catheter assembly 50 includes a plurality of temperature sensors 100a, 100b, …, 100n disposed at multiple locations along the length of the catheter tube 12, the infection diagnosis algorithm can be used by the diagnostic procedure to diagnose an infection in the patient's vasculature at any one or more of the multiple locations along the length of the catheter tube 12. Diagnosing an infection with the infection diagnosis algorithm is based on local temperature changes or trends thereof sensed by one or more temperature sensors at one or more of the multiple locations, respectively. For example, an infection at the insertion site can be diagnosed by a rising trend in the temperature data provided by a temperature sensor proximal to the proximal end of the catheter tube 12. In another example, sepsis can be diagnosed by a rising trend in the temperature data provided by several of the plurality of temperature sensors 100a, 100b, …, 100n along the length of the catheter tube 12.

[0127] One or more functions of the diagnostic process may include a flush compliance function to ensure flush compliance after blood is withdrawn from the catheter assembly 50, which in turn ensures patency of the catheter assembly 50. The flush compliance function is configured to provide an alert, such as a visual alert on the console 2402 or the display screen 2414, or an audible alert of the console 2402, when the temperature change of the compliant flush does not occur as expected due to the withdrawal of blood at the patient's body temperature from the catheter assembly 50 and subsequent flushing of the catheter assembly 50 with room temperature flush fluid or flushing of the catheter assembly 50 at recommended intervals (e.g., every 12 hours) to maintain device patency. As described above, the catheter assembly 50 may include at least one temperature sensor disposed within the catheter lumen 12 for temperature measurement within the catheter lumen 12, at least one temperature sensor disposed within the hub 16 for temperature measurement within the hub 16, or at least one temperature sensor disposed within each component of the catheter lumen 12 and the hub 16 for temperature measurement therein. The flush compliance function is configured to provide an alert when the temperature change of the compliant flush does not occur as expected at the temperature sensor of the catheter lumen 12, at the temperature sensor of the hub 16, or at both temperature sensors when room temperature flush fluid is flushed through the catheter assembly 50 (e.g., after blood at the patient's body temperature is withdrawn from the catheter assembly 50).

[0128] One or more functions of the diagnostic process may include a blood flow rate function. According to the blood flow rate function, the diagnostic process utilizes a blood flow rate algorithm to monitor the blood flow rate around a specific or primary temperature sensor disposed in the distal portion of the catheter lumen 12 or some other length of the catheter lumen 12. The primary temperature sensor is communicatively coupled to a PID controller of the console 2402, which is configured to maintain it at a set number of degrees above the blood temperature by sending a control signal to the primary temperature sensor. The amount of power required to maintain the primary temperature sensor at a set number of degrees above the blood temperature is monitored by the blood flow rate algorithm, such as the control signal sent by the PID controller. Since the amount of power required to maintain the primary temperature sensor at a set number of degrees above the blood temperature is proportional to the blood flow rate, the diagnostic process may utilize the blood flow rate algorithm to determine the blood flow rate around the primary sensor. The blood flow rate can be used to confirm the initial position of the catheter lumen 12 (or the like) in the blood vessel and to ensure sufficient dilution of the infusion at the distal end 13 of the catheter lumen 12. The blood flow rate can also be used to detect catheter migration or vascular occlusion. In addition, the blood flow rate can be used to diagnose an infection at the insertion site, optionally in combination with an infection diagnostic algorithm. Since a decrease in the blood flow rate at the insertion site is typically due to swelling caused by infection, a decrease in the blood flow rate measured by the blood flow rate algorithm can be used as an indicator of infection or as a check for infection diagnosis by the infection diagnostic algorithm.

[0129] When the vasculature access device is a cannula or a needle and the single temperature sensor in the distal portion of its elongate lumen is the primary temperature sensor, the input to the console 2402 includes the local maximum of the blood flow rate data generated from the blood flow rate algorithm, and the output from the console 2402 to the GUI includes an indication of successful placement of the distal portion of the elongate lumen in the patient's vasculature on the display screen 2414.

[0130] One or more of the functions of the diagnostic process may include a cardiac parameter function. According to the cardiac parameter function, the diagnostic process uses a blood flow rate algorithm in combination with a cardiac parameter algorithm to determine cardiac parameters, including heart rate and cardiac stroke volume. The heart rate may be measured by input from sensors other than blood flow fluctuations or temperature sensors. For example, the heart rate may be measured by an ECG probe or an ECG sensor 34.

[0131] One or more of the functions of the diagnostic process may include a catheter tracking function. According to the catheter tracking function, the diagnostic process uses a blood flow rate algorithm in combination with a catheter tracking algorithm to determine when the primary temperature sensor is advanced past a vasculature junction based on the volumetric increase of the blood flow. The blood flow and the resulting change in blood flow may be tracked as catheter tracking data, and the diagnostic process may use this data to determine the trend of the blood flow. The diagnostic process is configured to provide the catheter tracking data or the trend determined therefrom as an input to a display server for output to the GUI of the display screen. The output of the GUI provides an indication of the position of the catheter lumen 12 in the patient's vasculature to the clinician.

[0132] In addition, according to the catheter lumen tracking function, the diagnostic process may be configured to determine misalignment of the catheter lumen 12 in the patient's vasculature based on temperature data from an auxiliary temperature sensor disposed within the catheter lumen 12, proximal to the aforementioned primary temperature sensor. When the catheter lumen 12 is moving against or is oriented against the blood flow, the temperature data from the auxiliary temperature sensor indicates the patient's blood temperature. Since the primary temperature sensor is at a set number of degrees higher than the blood temperature, when the catheter lumen 12 is moving with the blood flow, the temperature data from the auxiliary temperature sensor indicates an increase in blood temperature. Information regarding the blood temperature or the increased blood temperature may be provided as a discrete or continuous input to the display server for output to the GUI of the display screen. The output of the GUI provides an indication of the misalignment of the catheter lumen 12 in the patient's vasculature to the clinician.

[0133] Notwithstanding, misalignment of the catheter lumen 12 may also be determined by a change in the blood flow rate around the primary sensor by the blood flow rate algorithm.

[0134] One or more of the functions of the diagnostic process may include an ECG function for processing ECG data. As described above, the catheter assembly 50 may include an ECG sensor 34. Optionally, the diagnostic system further includes an electrocardiogram ("ECG") probe configured to be disposed within the catheter lumen 12. The ECG function is for processing ECG data from the ECG sensor 34 or the ECG probe when the catheter lumen 12 in which the ECG sensor 34 or the ECG probe is disposed is positioned within a patient's vasculature. The ECG function confirms the position of the distal end 13 or tip of the catheter lumen 12, monitors migration of the tip of the catheter lumen 12, determines heart rate, or a combination thereof. The ECG function of the diagnostic process can be used to confirm the position of the catheter tip during catheter placement, monitor migration of the catheter tip, or measure heart rate for the cardiac parameter function of the diagnostic process.

[0135] The various functions of the diagnostic process can be used together to provide clinical data for patient monitoring. This is particularly useful when the diagnostic system 2400 is coupled to an infusion system or a patient monitoring system. For example, with respect to an infusion system, the diagnostic system 2400 can be configured to provide clinical data for correlation with drug infusion data regarding a patient's response to drug infusion. Temperature, blood flow rate, and cardiac output data can then be trended with drug infusion rate data, and the foregoing data can be uploaded to an electronic medical record or a database of patient data, and then these data can be used with artificial intelligence algorithms to improve patient care.

[0136] Method

[0137] The method of the diagnostic system 2400 includes an instantiation step: instantiating a diagnostic process in a memory 2406 (e.g., main memory 2408) of the console 2402, the diagnostic process having one or more functions for at least processing temperature data.

[0138] The method further includes a sending step: sending temperature data from the catheter assembly 50 to the console 2402 from any of the temperature sensors 100 or multiple temperature sensors 1001, 100b, …, 100n. The method further includes a loading step: loading the temperature data into the memory 2406 (e.g., main memory 2408). The method further includes a processing step: processing the temperature data with a processor 2404 of the console 2402 according to the one or more functions for processing temperature data.

[0139] The method further includes a display step: displaying at least a temperature reading associated with any temperature sensor of the catheter assembly when the catheter assembly 50 is placed within a patient's vasculature in a GUI on a display screen 2414 configured to communicate with the console 2402.

[0140] The method can include a monitoring step: monitoring the blood flow rate around any temperature sensors of a catheter assembly 50 disposed within a patient's vasculature through a blood flow rate function using a blood flow rate algorithm. Also, the blood flow rate is proportional to the amount of power required to maintain the temperature sensor temperature at a set number of degrees above the blood temperature.

[0141] The diagnostic systems and methods disclosed herein provide valuable clinical data to clinicians by integrating one or more sensors into a vasculature access device. This eliminates the need to place additional vasculature devices within the patient and reduces the risk of patient infection and other complications. In addition, the diagnostic systems disclosed herein provide additional data and features not currently present in such additional vasculature devices already on the market, such as blood flow quality around the vasculature device, compliance monitoring of a flushing protocol, and monitoring of the position of the vasculature device relative to a vascular junction.

[0142] Although some specific embodiments have been disclosed herein and although some details of the specific embodiments have been disclosed, these specific embodiments are not intended to limit the scope of the concepts provided herein. Additional adaptations or modifications will be apparent to those of ordinary skill in the art and, in a broader sense, these adaptations or modifications are also included. Thus, departures may be made from the specific embodiments provided herein without departing from the scope of the concepts disclosed herein.

Claims

1. A diagnostic system, comprising: A catheter assembly, the catheter assembly comprising: A catheter tube that defines 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 channel 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 main catheter tube temperature sensor and an auxiliary catheter tube temperature sensor proximal to the main catheter tube temperature sensor, for determining misalignment of the catheter tube within a patient's vasculature, each of the main catheter tube temperature sensor and the auxiliary catheter tube temperature sensor being configured for temperature measurement within the catheter tube; A console configured to communicate with the catheter assembly, the console including a memory, a processor, and a proportional-integral-derivative controller for instantiating a diagnostic process having at least one or more functions for processing temperature data when the catheter tube is disposed within a patient's vasculature, Wherein the proportional-integral-derivative controller is configured to maintain the main catheter tube temperature sensor at a set temperature and monitor the amount of power used to maintain the main catheter tube temperature sensor at the set temperature, wherein the amount of power used is proportional to the blood flow rate, and wherein the blood flow rate indicates catheter placement or catheter misalignment, and Wherein the processor is configured to measure blood temperature with the auxiliary catheter tube temperature sensor as the catheter tube moves through the vasculature, wherein a first blood temperature indicates movement against the blood flow direction, wherein a second blood temperature that is elevated relative to the first blood temperature indicates movement with the blood flow direction, and wherein determining whether the catheter tube is moving against or with the blood flow direction indicates catheter placement or catheter misalignment; and A display screen configured to communicate with the console, the display screen being configured to display a graphical user interface that includes at least temperature readings associated with the plurality of temperature sensors.

2. The diagnostic system according to claim 1, wherein the console is configured to instantiate a display server that is configured to coordinate inputs to and outputs from the console, the inputs including selection of the one or more functions of the diagnostic process, and the outputs including the graphical user interface.

3. The diagnostic system according to claim 1 or 2, wherein the memory includes one or more temperature data processing algorithms for processing the temperature data from the plurality of temperature sensors of the catheter assembly using the diagnostic process when the catheter tube is placed within the patient's vasculature.

4. The diagnostic system according to claim 1, wherein each of the plurality of temperature sensors is disposed at a different one of a plurality of positions along the length of the catheter tube for measuring local temperature.

5. The diagnostic system according to claim 4, wherein the memory includes an infection diagnosis algorithm for diagnosing an infection in the patient's vasculature or subcutaneous tissue at any one or more of the plurality of positions along the length of the catheter lumen during the diagnostic process based on local temperature changes or trends thereof of the temperature sensor or the plurality of temperature sensors at the one or more of the plurality of positions, respectively.

6. The diagnostic system according to claim 1, wherein the catheter lumen includes at least one catheter lumen temperature sensor disposed within the catheter lumen, at least one hub temperature sensor disposed within the hub, or a combination thereof, configured for temperature measurement within the catheter lumen, the hub, or both the catheter lumen and the hub.

7. The diagnostic system according to claim 6, wherein one or more functions of the diagnostic process include a flush compliance function configured to provide a console-based alert when a temperature change indicative of a compliant flush does not occur as expected at the catheter lumen temperature sensor, the hub temperature sensor, or both the catheter lumen temperature sensor and the hub temperature sensor when room temperature flush fluid is flushed through the catheter assembly after withdrawal of patient body temperature blood from the catheter assembly or at a recommended time interval or instance.

8. The diagnostic system according to claim 1, wherein the proportional integral derivative controller is communicatively coupled to the main catheter lumen temperature sensor, and wherein the set temperature is a set number of degrees above the blood temperature.

9. The diagnostic system according to claim 8, wherein one or more functions of the diagnostic process include a blood flow rate function in which the diagnostic process monitors the blood flow rate around the main catheter lumen temperature sensor using a blood flow rate algorithm based on the amount of power required to maintain the main catheter lumen temperature sensor at the set number of degrees above the blood temperature.

10. The diagnostic system according to claim 9, wherein one or more functions of the diagnostic process include a cardiac parameter function in which the diagnostic process determines cardiac parameters including cardiac stroke volume using the blood flow rate algorithm in combination with a cardiac parameter algorithm.

11. The diagnostic system according to claim 9, wherein one or more functions of the diagnostic process include a catheter tracking function in which the diagnostic process determines when the main catheter lumen temperature sensor is advanced past a vascular junction based on an increase in the volume of blood flow using the blood flow rate algorithm in combination with a catheter tracking algorithm.

12. The diagnostic system according to claim 11, wherein the diagnostic process is configured to provide catheter pathway tracking data generated by the catheter pathway tracking algorithm as a display server input for display server output to the graphical user interface on the display screen, and the display server output to the graphical user interface provides an indication of the position of the catheter pathway in the vasculature of the patient to the clinician.

13. The diagnostic system according to claim 1, further comprising an electrocardiogram probe or wire embedded within the catheter assembly, and one or more functions of the diagnostic process include an electrocardiogram function for processing electrocardiogram data when the electrocardiogram probe is placed within the catheter pathway and the catheter pathway is placed within the vasculature of the patient to confirm the position of the tip of the catheter pathway, monitor migration of the tip of the catheter pathway, determine heart rate, or a combination thereof.

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