Diagnostic system including a temperature-sensing blood vessel device

Abstract

A diagnostic system and method including a temperature-sensitive vascular device. The diagnostic system can include a catheter assembly for establishing vascular or other access within a patient's body. The catheter assembly includes one or more sensors, e.g., temperature sensors, capable of monitoring one or more physiological aspects of the patient, e.g., body temperature, when a portion of the catheter is positioned within the patient's body. The catheter assembly can be configured to transmit or forward data related to the physiological aspects to another location, such as a console, a smartphone or another mobile device, a nurse's station, or the patient's electronic medical record. The diagnostic system method includes an instantiation step of instantiating a diagnostic process in a memory of the diagnostic console, the diagnostic process having one or more functions for at least processing temperature data from the catheter assembly.

Description

Background Art

[0001] A patient's body temperature can be measured by any of a number of existing temperature probes, including, but not limited to, skin temperature measurement probes, oral thermometers, tympanic thermometers, esophageal temperature measurement probes, rectal thermometers, temperature-sensing bladder catheters, or the like. Although effective, the aforementioned temperature probes typically only provide instantaneous measurements of temperature data for specific tissues at specific locations, which limits the practicality of such temperature probes in patient treatment. What is needed is a temperature probe having one or more temperature sensors in combination with means for augmenting temperature data to assist in patient diagnosis and expand treatment options.

[0002] Disclosed herein are diagnostic systems and methods including a temperature-sensing blood vessel device to address the foregoing.

Summary of the Invention

[0003] In some embodiments, the present specification discloses a diagnostic system including 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 flow path in fluid communication with the lumen of the catheter tube. A single temperature sensor is disposed within the catheter tube, the hub, or the extension leg and configured to measure the temperature therein. Multiple temperature sensors are disposed within the catheter tube, the hub, the extension leg, or a combination thereof and configured to measure the temperature 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 one or more functions for processing at least temperature data while the catheter tube is disposed within a patient's vascular structure. The display screen is configured to communicate with the console. The display screen is configured to display a graphical user interface (GUI) including at least the measured temperature associated with one or more sensors.

[0004] In some embodiments, the console is configured to instantiate a display server configured to reconcile input to the console and output from the console. The input includes the selection of one or more functions of the diagnostic process. The output includes the GUI.

[0005] In some embodiments, the memory includes one or more temperature data processing algorithms for processing temperature data from any temperature sensor of the catheter assembly using the diagnostic process while the catheter tube is disposed within a patient's vascular structure.

[0006] In some embodiments, the catheter tube includes a plurality of temperature sensors. Each temperature sensor of the plurality of temperature sensors is disposed at a different location among a plurality of locations along the length of the catheter tube for measuring local temperature.

[0007] In some embodiments, the memory includes an infectious disease diagnostic algorithm for diagnosing an infectious disease in a patient's vascular structure or in subcutaneous tissue using a diagnostic process at any one or more of a plurality of locations along the length of the catheter tube. Diagnosis of an infectious disease using the infectious disease diagnostic algorithm follows local temperature changes or trends of the temperature sensors or each of the plurality of temperature sensors at one or more of the plurality of locations.

[0008] In some embodiments, the catheter tube includes at least one catheter tube temperature sensor disposed within the catheter tube, at least one hub temperature sensor disposed within the hub, or a combination thereof, and is configured for temperature measurement at the catheter tube, the hub, or both the catheter tube and the hub.

[0009] In some embodiments, one or more functions of the diagnostic process include a flushing compliance function. The flushing compliance function is configured to issue a console-based alert when the flushing compliant temperature change expected from flushing the catheter assembly with room temperature flushate does not occur at the catheter tube temperature sensor, the hub temperature sensor, or both the catheter tube temperature sensor and the hub temperature sensor, after the patient body temperature blood is drawn from the catheter assembly or at recommended intervals or when recommended.

[0010] In some embodiments, the catheter tube includes a primary catheter tube temperature sensor disposed within the catheter tube. The console includes a proportional-integral-derivative (PID) controller communicatively coupled to the primary catheter tube temperature sensor. The PID controller is configured to maintain the primary catheter tube temperature sensor at a set degree above the blood temperature.

[0011] In some embodiments, one or more functions of the diagnostic process include a blood flow function. In accordance with the blood flow function, the diagnostic process utilizes a blood flow algorithm to monitor the blood flow rate near the primary catheter tube temperature sensor based on the amount of electrical power required to maintain the primary catheter tube temperature sensor at a set degree above the blood temperature. The blood flow rate is proportional to the amount of electrical power required to maintain the primary catheter tube temperature sensor at a set degree above the blood temperature.

[0012] In some embodiments, one or more functions of the diagnostic process include a heart parameter function. In accordance with the heart parameter function, the diagnostic process utilizes a combination of the blood flow algorithm and a heart parameter algorithm to determine heart parameters including cardiac output.

[0013] In some embodiments, one or more functions of the diagnostic process include a catheter tracking function. In accordance with the catheter tracking function, the diagnostic process utilizes a combination of the blood flow algorithm and the catheter tracking function to determine when the primary catheter tube temperature sensor advances beyond the vascular junction as the blood flow rate increases.

[0014] In some embodiments, the diagnostic process is configured to provide catheter tracking data obtained from a catheter tracking algorithm as a display server input for display server output to a GUI on a display screen. The display server output to the GUI indicates to the clinician the location of the catheter tube within the patient's vascular structure.

[0015] In some embodiments, the catheter tube includes a secondary catheter tube temperature sensor disposed within the catheter tube proximal to the primary catheter tube temperature sensor to determine a positional abnormality of the catheter tube within the patient's vascular structure.

[0016] In some embodiments, the catheter tracking function is configured to determine a positional abnormality of the catheter according to temperature data from the secondary catheter tube temperature sensor. The temperature data from the secondary catheter tube temperature sensor indicates the patient's blood temperature when the catheter tube is moved against the blood flow. The temperature data from the secondary catheter tube temperature sensor indicates an elevated blood temperature when the catheter tube is moved along the blood flow because the primary catheter tube temperature sensor is set at a degree above the blood temperature.

[0017] In some embodiments, the diagnostic process further includes an electrocardiogram (ECG) stylet or lead embedded within the catheter assembly. One or more functions of the diagnostic process include an ECG function for processing ECG data when the ECG stylet is disposed within the catheter tube and the catheter tube is disposed within the patient's vascular structure. The ECG function locates the tip of the catheter tube, monitors the movement of the tip of the catheter tube, and determines the heart rate, or a combination thereof.

[0018] Also, in this specification, in some embodiments, a diagnostic system including a vascular access device, a console, and a display screen is also disclosed. The vascular access device includes a long tube and a single temperature sensor. The long tube defines at least one lumen extending between a proximal end and a distal end of the long tube. The single temperature sensor disposed within the distal portion of the long 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 configured to instantiate a diagnostic process having a function of processing at least temperature data while the distal end of the long tube is disposed within the patient's vascular structure. The console also includes a PID controller communicatively coupled to the temperature sensor. The PID controller is configured to maintain the temperature sensor at a set degree above the blood temperature. The display screen is configured to communicate with the console. The display screen is configured to display a GUI including at least the measured temperature associated with the temperature sensor.

[0019] In some embodiments, the function of the diagnostic process is a blood flow function. According to the blood flow function, the diagnostic process utilizes a blood flow algorithm to monitor the blood flow rate near the temperature sensor based on the amount of power required to maintain the temperature sensor at a set degree above the blood temperature. The blood flow rate is proportional to the amount of power required to maintain the temperature sensor at a set degree above the blood temperature.

[0020] In some embodiments, the console is configured to instantiate a display server configured to reconcile input to and output from the console. The input includes a maximum value from blood flow rate data obtained from the blood flow algorithm. The output includes a display on the GUI of the display screen regarding the successful placement of the distal end of the long tube within the patient's vascular structure.

[0021] Also, in this specification, in some embodiments, a method of a diagnostic system is disclosed that includes an instantiation step of instantiating a diagnostic process having one or more functions for processing at least temperature data in the memory of a console. The method also includes a transmission step of transmitting 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. Alternatively, the catheter assembly has a plurality of temperature sensors disposed within a catheter tube, a hub, an extension leg, or a combination thereof. The method also includes a loading step of loading the temperature data into the memory. The method also includes a processing step of processing the temperature data using a processor of the console according to one or more functions for processing the temperature data. The method also includes a display step of displaying a measured temperature associated with at least one or more sensors on a GUI of a display screen configured to communicate with the console.

[0022] In some embodiments, the method also includes a monitoring step of monitoring blood flow near any temperature sensor of a catheter assembly disposed within a patient's vascular structure using a blood flow function that utilizes a blood flow algorithm. The blood flow is proportional to the amount of electrical power required to maintain the temperature of the temperature sensor at a set number of degrees above the blood temperature.

[0023] The blood flow is proportional to the amount of electrical power required to maintain the temperature of the temperature sensor at a set number of degrees above the blood temperature. These and other features of the concepts provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which more particularly describe certain embodiments of such concepts.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0025] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein can be easily separated from the specific embodiments and, optionally, can have features that can be combined with or substituted for the features of any of the many other embodiments disclosed herein.

[0026] Regarding the terms used herein, it should also be understood that the terms are for the purpose of describing some specific embodiments and 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 steps within a group of multiple features or multiple steps and do not provide sequential limitations or numerical restrictions. For example, the "first", "second", and "third" features or steps do not necessarily have to appear in that order, and a specific embodiment including such features or steps does not necessarily have to be limited to three features or steps. Labels such as "left", "right", "front", "rear", "up", "down", and other similar terms are used for convenience and do not, for example, mean a specific fixed position, orientation, or direction. Instead, such notations are used, for example, to reflect relative positions, orientations, or directions. The singular forms "a", "one", and "the" include plural references unless the context clearly dictates otherwise.

[0027] Regarding "proximal", for example, the "proximal portion" or "proximal end portion" of the catheter disclosed in this specification includes the portion of the catheter intended to be near the clinician when the catheter is used in a patient. Similarly, for example, the "proximal length" of the catheter includes the length of the catheter intended to be near the clinician when the catheter is used in a patient. For example, the "proximal end" of the needle includes the end of the catheter intended to be near the clinician when the catheter is used in a patient. The proximal portion, proximal end portion, or proximal length of the catheter can include the proximal end of the catheter, but the proximal portion, proximal end portion, or proximal length of the catheter does not necessarily include the proximal end of the catheter. That is, unless otherwise indicated by the context, the proximal portion, proximal end portion, or proximal length of the catheter is not the distal portion or distal length of the catheter.

[0028] Regarding "distal", for example, the "distal portion" or "distal end portion" of the catheter disclosed in this specification includes the portion of the catheter intended to 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 intended to be near or within the patient when the catheter is used in a patient. For example, the "distal end" of the needle includes the end of the catheter intended to be near or within the patient when the catheter is used in a patient.

[0029] The distal portion, distal end portion, or distal length of the catheter can include the distal end of the catheter, but the distal portion, distal end portion, or distal length of the catheter does not necessarily include the distal end of the catheter. That is, unless otherwise indicated by the context, the distal portion, distal end portion, or distal length of the catheter is not the distal portion or distal length of the catheter.

[0030] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art. Disclosed herein are diagnostic systems and methods that include warm-sensing vascular devices such as catheter assemblies and needles for establishing vascular access or other access within a patient's body. The vascular devices and complementary components such as fixation devices for the vascular devices will be described first, followed by a description of the diagnostic system that includes the vascular devices. Finally, the method of the diagnostic system will be described. Exemplary assemblies, systems, and sensors can be found in U.S. Patent No. 10,433,790 and U.S. Published Patent Application No. 2019 / 0374162, each of which is hereby incorporated by reference in its entirety into this application.

[0031] Vascular Devices and Complementary Components Vascular access devices include catheter assemblies, cannulas, needles, or other such medical devices that include elongate tubes configured for vascular insertion or placement. Catheter assemblies can include peripherally inserted central catheters (PICCs), central venous catheters (CVCs), arterial catheters, Foley catheters or the like, peripheral intravenous (IV) catheters, midline catheters, intermediate dwell catheters, feeding tubes, or the like, some of which will be described in more detail below.

[0032] When a vascular access device is similar and has a long tube that defines at least one lumen extending between a cannula, a needle, or the proximal and distal ends thereof, the long tube can include one or more sensors that enable monitoring of one or more physiological aspects or other parameters of the patient, or, if the vascular access device is disposed within the patient, physical aspects or the operation of the vascular access device itself. For example, the vascular access device can include a single temperature sensor disposed within the distal end of the long tube and configured for temperature measurement therein. Additional details regarding the foregoing are described below with respect to catheter assembly-type vascular access devices.

[0033] The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects or other parameters of the patient, or, if the catheter assembly is disposed within the patient, physical aspects or the operation of the catheter assembly itself. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, and the like. The sensors included in the catheter assembly are positioned to enable detection of data related to these or other parameters. In some embodiments, one or more sensors are disposed within or proximate to the hub of the catheter assembly, although a variety of other locations are possible. Also, other components and structures associated with the catheter assembly (e.g., needleless connectors, etc.) can include one or more sensors for monitoring physiological / physical aspects.

[0034] Furthermore, the catheter assembly includes the ability to wirelessly transmit or otherwise transfer data related to the detected physiological / physical aspects to another location, which is also referred to herein as the receiving location. Examples of data receiving locations include a patient electronic medical record (EMR), a patient monitoring device, a smartphone or other portable device, a tablet, a storage location, a computer server, a nurse station, or a variety of other destinations.

[0035] First, referring to FIG. 1, this depicts various details of a catheter assembly (the "catheter") generally designated 10 in accordance with several embodiments. As shown, catheter 10 includes an elongate catheter tube 12 that defines one or more lumens 14 extending between a proximal end and a distal end 13 of the catheter tube. The proximal end of the catheter tube is operably connected to a hub 16 and further operably connected to one or more extension legs 18 that extend one or more lumens 14 to the remainder of one or more flow paths through the catheter assembly 10. A connector 20, such as a luer connector, is disposed at the proximal end of the extension leg 18. Hub 16 includes two suture wings 22 that extend oppositely from the body of the hub 16. Each suture wing 22 includes a suture hole 24. It should be noted that hub 16 can be a bifurcated hub, a trifurcated hub, etc., depending on the number of flow paths defined therethrough.

[0036] According to several embodiments, one or more sensors, also referred to herein as "sensor array" 30, are included in catheter 10 to enable sensing of data related to one or more physiological aspects of a patient, or, if the catheter tube 12 is disposed within a vascular structure (as described herein) or other suitable interior of the patient's body, the physical aspects of the catheter. A number of sensors can be included in catheter 10, although the number, type, size, location, function, and desired use of the various sensors can differ from those illustrated and described herein. It should be noted that sensor array 30 can, in several embodiments, include only one sensor. When only one particular sensor is described below, it is recognized that multiple sensors of a particular type can be included in the same or different locations within the catheter assembly.

[0037] As shown in FIG. 1, the 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 typically sense the patient's venous pressure through a fluid (such as blood or saline) present in the lumen 14 of the catheter tube 12. As shown, the pressure sensor 32 is operably communicated with the flow path 26 in the hub and is further arranged in the hub 16 such that it is in fluid communication with the lumen 14 of the single lumen catheter tube 12 as shown in FIG. 1. The pressure sensor can also be employed in other locations, including within the catheter tube 12, the extension leg 18, etc. In some embodiments, the pressure sensor 32 is the medical pressure sensor NPC-100 or NPC-120 manufactured by Amphenol Corporation, although other pressure sensors may also be employed. In some other embodiments, the pressure sensor includes a strain-sensitive Wheatstone bridge. The sensing surface of the pressure sensor 32 can be in direct contact with the fluid present in the flow path of the hub 16. It should be noted that the size, shape, and other configurations of the hub 16 may be increased compared to those illustrated and described herein to accommodate the sensor array 30.

[0038] In this specification, an ECG sensor 34, also referred to herein as an ECG electrode or an electrical sensor, is also included in the catheter assembly to enable detection of an ECG signal emanating from a patient's heart in conjunction with an additional ECG sensor / electrode placed external to the patient's skin or in proximity to the catheter assembly. As shown, the ECG sensor 34 can be disposed within the hub 16 so as to be in direct contact with the fluid present within the lumen 14 of the hub flow path 26 and the catheter tube 12. The ECG sensor can also be employed in other locations, including within the catheter tube 12, within the extension leg 18, etc. The ECG sensor 34 includes conductors capable of detecting an ECG signal of the patient's heart that is present within the fluid of the hub fluid flow path 26 and the catheter tube lumen 14, although other types of ECG sensors can also be employed. Further details regarding systems and methods of using an ECG sensor to guide a catheter assembly to a desired location within a patient's body 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 disclosure of which is incorporated herein by reference.

[0039] As described, the sensor array 30 (herein including a pressure sensor 32 and an ECG sensor 34) is disposed within the hub 16 sized to provide the volume necessary for the sensors. It should be noted that the size, shape, and configuration of the hub 16 can be different from those shown and described to accommodate the sensors. The sensors can be placed along the catheter tube 12, the extension leg 18, or other parts of the catheter 10, including at either end thereof, etc. It should also be noted that a variety of sensors for detecting body measurements, the physiological aspects of the patient, or the physical aspects of the catheter can be included in the catheter assembly, some of which are further described below.

[0040] FIG. 1 further shows that the hub 16 (or other suitable location) includes a printed circuit board (PCB) 36 configured to manage the operation of a sensor array 30, which here includes a pressure sensor 32 and an ECG sensor 34. The PCB 36 can include a microprocessor to manage the operation of the sensors. The PCB 36 can further include a power source to supply power to the sensor array 30, although in some embodiments, the power source can be located remotely from the PCB and even from the catheter 10. A non-volatile memory storage location, such as a flash memory, can also be included on the PCB 36 to enable the data sensed by the sensors of the sensor array 30 to be stored therein temporarily or permanently. The storage location can be made accessible to the user or transmitted to a desired location in a manner described below.

[0041] The PCB 36 can 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 referred to above. Such wireless transmission can be performed via Bluetooth®, Wi-Fi®, radio frequency, near-field communication (NFC), GPS, ANT, ZigBee®, or other methods that utilize electromagnetic radiation. The sensor data can be transmitted via a physical connection, such as a removable physical connection, a wire, etc., from the catheter 10. As described above, the sensor data (e.g., central venous pressure, ECG signal, temperature, etc.) is stored in a memory location included on the PCB 36 or other locations on the catheter 10. The PCB 36 can include a clock or timer circuit.

[0042] As shown in FIG. 1, the suture holes 24 of the suture wings 22 are configured to include electrical contacts that supply power to the sensors 30 and 34 of the sensor array 30 and the PCB 36. In particular, each suture hole 24 of the hub suture wing 22 includes an annular electrical contact 40, and the electrical contact is operably connected to the PCB 36 and the sensor array 30. A fixing device 50, such as the fixing device shown in FIGS. 4A-4C, is placed on the patient's skin and is operably connected to the catheter 10 and configured to fix the catheter 10 in place once the distal portion of the catheter has been inserted into the patient. To that end, the fixing device 50 includes a retainer 54 attached to an adhesive pad and a fixing arm that pivotally attaches (in a snap-fit configuration) removably on the suture wings 22 of the hub 16 to fix the hub in place.

[0043] The fixing device 50 can include additional functionality to power 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 operably connected to a battery 62 also included in the fixing device. The posts 58 are configured to be received into corresponding suture holes 24 of the catheter suture wings 22 such that electrical contact is established with the electrical contacts 40 of the suture holes. The battery 62 included on the fixing device 50 can thus power the sensors 32, 34 and the PCB 36 of the catheter hub 16. Of course, other external power sources can also be employed. In some embodiments, the electrical contact between the catheter and the fixing device can also be utilized to transfer sensor data therebetween. In some other embodiments, the fixing device can include a radio or other form to transmit sensor data received from the catheter. In still other embodiments, the PCB or the sensor can be included on the fixing device. It is recognized that the size, shape and other configurations of the fixing device can be different from those illustrated and described herein.

[0044] Figures 5A - 5C depict details of a fixation device 50 according to some embodiments, the fixation device including a pod 70 that includes, for example, a PCB and a battery for use with a sensor array 30 included on a catheter 10. This eliminates the need to place the PCB or battery on the catheter 10 itself. Figures 5A and 5C show that the pod 70 includes electrical contacts 60 on the upper surface of a retainer 54 and is configured to make electrical connection with corresponding electrical contacts on a hub 16 of the catheter 10. Thus, when the hub 16 is removably held by a fixation arm 56 of the fixation device 50, the sensor array 30 is powered and managed by the battery and PCB of the pod 70. The pod 70 can be configured to be removable from the fixation device 50, such that the pod 70 can be reused with a next fixation device. This would be convenient when replacing the catheter 10 or the fixation device 50. Thus, the pod 70 (PCB, battery, one or more sensors, etc.) can be removed from the fixation device and installed elsewhere, resulting in resource and cost savings. Note also that the battery and PCB can be similarly placed elsewhere. Thus, these and other variations are contemplated. Further details regarding the catheter fixation device relevant to what is described herein can be found in U.S. Patent No. 6,770,055, entitled "Universal Catheter Anchoring System", which is hereby incorporated by reference in its entirety.

[0045] In addition, in some embodiments, the fixation device 50 can include an ECG sensor (e.g., an electrode) that can cooperate with the ECG sensor 34 of the catheter 10, and thus can be used to detect a dual ECG signal and determine the proximity of the distal end 13 of the catheter tube 12 to the heart. This configuration can also be used to determine a positional abnormality of the distal end 13 of the catheter tube both during the placement of the first catheter and during the subsequent indwelling of the catheter in the patient. The sensor data from the pressure sensor 30 can also be used in association with the ECG signal to further detect a positional abnormality of the distal end of the catheter tube.

[0046] Figures 2 and 3 show double and triple lumen catheter configurations, respectively, relative to the single lumen configuration of Figure 1. Similar to that of Figure 1, the catheter 10 illustrated in Figures 2 and 3 includes a sensor array 30 similar to that illustrated in Figure 1, each including a corresponding pressure sensor 32, an ECG sensor 34, and a PCB 36. Also shown are electrical contacts 40 for electrical connection with the electrical contacts 60 of the fixation device 50 (Figures 4A - 4C). Note that each extension leg 18 of the catheter 10 in Figures 2 and 3 includes a corresponding one of the pressure sensors 32 so that pressure data can be sensed at each extension leg. More or fewer sensors than those illustrated in Figures 2 and 3 can also be employed, including, for example, a lactate sensor, an oxygen sensor, ultrasonic components, a GPS position sensor, a temperature sensor, a sizing sensor for measuring the lumen inner diameter, a flow rate sensor, a blood glucose meter, an oxygen sensor, a lactate sensor, a cardiac output sensor, an accelerometer, a blood volume and cardiac output sensor, etc., to sense the physiological aspects of the patient or the physical aspects of the catheter assembly.

[0047] FIG. 6 depicts a catheter 10 that includes three pressure sensors 30 at defined locations of corresponding extension legs 18 and an ECG sensor 34 disposed within one of the extension legs, each sensor being operably connected to a PCB 36 disposed within the hub 16. Thus, FIG. 5 demonstrates that the number, type, and arrangement of sensors and PCBs can differ from those already illustrated and described.

[0048] FIG. 7 depicts details of a sensor-equipped catheter 10 according to some embodiments, the hub 16 including an ultrasonic assembly 80 having upper and lower PCBs 82A and 82B configured to control ultrasonic transducers 84A and 84B, respectively. The ultrasonic transducers 84A and 84B can be used to ultrasonically evaluate the flow path 26 of the hub 16 to determine the contents of the lumen, as illustrated in FIGS. 8A-8D. For example, FIG. 8A shows that when air is present in the flow path 26, no ultrasonic signal is present as depicted in the ultrasonic signal graph 90 of FIG. 8A. In contrast, when a fluid such as fluid A is present in the flow path 26, the ultrasonic transducers 84A and 84B return a signal of a defined voltage that matches the composition of fluid A, as can be seen from the graph 90 of FIG. 8B. If a fluid B having a composition different from that of fluid A is present in the flow path 26, the ultrasonic transducers 84A and 84B return a signal of a defined voltage that matches the composition of fluid B, as can be seen from the graph 90 of FIG. 8C. Further, when both fluid and air are present in the flow path 26, the graph 90 of FIG. 8D shows that a voltage signal that varies by the ultrasonic transducers 84A and 84B is detected. Thus, the ultrasonic transducers 84A and 84B, which are coupled to a battery and a PCB as further described above, can assist the user in determining the presence of a particular substance within the flow path 26 of the hub 16 or within the lumen of other catheter components, depending on the arrangement of the ultrasonic transducers. In some other embodiments, only a single ultrasonic transducer is employed.

[0049] Figures 9A and 9B depict details of a sensor-equipped catheter 10 according to some embodiments, where hub 16 includes a PCB 82 disposed therein and operably connected to a temperature sensor 100, such as a thermocouple, positioned to measure deep body temperature via blood or other fluid present within catheter lumen 14. As shown in Figure 9B, temperature sensor 100 can be positioned adjacent to lumen 14 via a skiving or cavity 108 longitudinally defined within catheter tube 12 or hub 16. Potting 106 can optionally be used to fill cavity 108 around temperature sensor 100. If temperature sensor 100 (e.g., a thermistor) is configured to contact the infusion fluid, temperature sensor 100 can be used to measure its flow rate as described herein for blood flow rate. When used with the pressure determination means disclosed herein, more accurate detection of occlusion is possible. In some embodiments, temperature sensor 100 includes a Series 400 Model 401 thermistor available from Cole-Palmer Inc., of Vernon Hills, Illinois.

[0050] Figure 10 shows that various sensors can be included as part of sensor array 30 within hub 16 or other suitable locations. As illustrated in Figure 10, 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 adjacent to flow path 26 of hub 16 as needed to sense relevant parameters detected within the fluid present in the flow path. The particular arrangement of sensors can differ from that shown here.

[0051] As described in some of the above embodiments, FIG. 11 shows that the smartphone 120 can be a receiving location for wirelessly receiving data from one or more of the sensors of the sensor array. Examples of wireless systems capable of transmitting data include Bluetooth (registered trademark), Wi-Fi (registered trademark), radio frequency, near field communication (NFC), ANT, ZigBee (registered trademark), and the like. Such data transmission can be relayed by a software-based application or other intermediate device. Thereby, the clinician can receive mobile updates and other sensor data 124 from the catheter 10 via the display screen 122 of the smartphone 120 (or by other media including sound, vibration, etc.) in order to be able to monitor the patient's progress or condition. As described above, other receiving locations for sensor data include the patient's electronic medical record (EPR), patient monitoring devices, other portable devices including electronic tablets and laptop computers, electronic storage locations, computer servers, nurse stations, medical devices such as pumps attached to the catheter, and a variety of other destinations. It is recognized that devices, components, computers, etc. installed at the receiving location can operate on the received data, including analysis, trend analysis, alarm functions, etc.

[0052] FIG. 12 depicts a catheter 10 according to some embodiments, showing the catheter inserted into the catheter arm 128 such that a majority of the catheter tube 12 is disposed within the patient's vascular structure. A hub 16 that includes one or more sensors is also shown operably connected via a connection wire 134 to an auxiliary device such as an armband 130 positioned around the patient's arm 128. The armband 130 is positioned proximate to the exterior of the catheter 10 in some embodiments, although in other embodiments, its location and specific shape, size, configuration, as well as the body-worn technique may vary. As shown, the armband 130 includes various components that cooperate with the sensors of the catheter 10 via the connection wire 134, including a PCB 36 and a wireless communication module 136 (included in the PCB in other embodiments). Sensor data sensed by the sensors of the catheter 10 can be transferred from the catheter 10 via the connection wire 134 to the components of the armband 130, where the data can be processed (e.g., by the PCB 36) or transmitted to a remote location (e.g., by the wireless communication module 136). In some other embodiments, the operable connection between the catheter 10 and the armband 130 is similarly a wireless connection.

[0053] Placing the PCB 36 and the wireless communication module 136 on the armband 130 can leave space on the catheter and eliminate the need to replace relatively expensive components when the catheter 10 itself is periodically 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 to function with the new catheter as they did with the previous catheter. Note that various other components, including a battery for powering sensors included on the catheter, additional sensors including an ECG sensor, etc., can also be included on the armband 130. As described above, the armband 130 is a representative of other wearable and non-wearable auxiliary devices that can be operably connected to the sensors of the catheter 10 to facilitate its operation. Also note that the components that can be included on the armband / auxiliary device can be made replaceable / reusable. In some embodiments, the PCB, battery, or wireless communication module can be included on the catheter fixing device. In some other embodiments, the aforementioned components can be included on a platform that can be removably attached to the armband. In some other embodiments, the armband or similar components include a disposable shield for separating it from the patient or providing isolation from contaminants.

[0054] Some of the foregoing embodiments include a pressure sensor 32 configured to sense data regarding 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 be further employed to detect when an occlusion, such as a fibrin sheath or thrombus, may be present in the lumen 14 of the catheter tube 12. FIG. 13 shows, for example, a pressure graph 140 including a pressure curve 142 depicting the level of pressure over time within the catheter tube lumen 14 sensed by the pressure sensor 32, such as in the configuration of the pressure sensor of FIG. 10, during a flushing procedure in which a user flushes fluid through the catheter 10 using a syringe connected to the luer connector 20 to maintain the patency of the catheter tube lumen 14. As shown, the pressure curve 142 includes various pressure peaks 144 caused by the user pulsing the syringe at moments of additional pressure. This is done to sweep away any minute obstructions that may have formed within the catheter tube lumen 14 or within other areas of the catheter fluid path. If an occlusion is present at the distal end 13 of the catheter tube or within the lumen 14 (see, for example, occlusion 178 of FIG. 15), the pressure curve 142 either rises (i.e., vertically shifts upward along the pressure y-axis) or broadens (i.e., lengthens along the time x-axis).

[0055] More specifically, the hydrodynamic resistance R of a fluid is generally related to the fluid flow rate Q and the injection pressure P by the following relationship. P = Q * R (1) From this, the following equation can be obtained.

[0056] R = ∫(from t1 to t2) P dt / V (2) In the above formula, V is the known amount of fluid injected into the catheter 10, t1 is the time at the start of the fluid injection process, t2 is the time at the end of the fluid injection process (see FIG. 13), and it should be noted that P indicates the instantaneous pressure at each point in time during the fluid injection procedure. By comparing the resistance R of fluid injection through the catheter tube 12 over a certain period (using the above formula) with the resistance R0 at a previous time point such as when the catheter 10 is first inserted into the patient and is considered to be unobstructed or patent, the percentage possibility of occlusion within the catheter can be obtained by the following formula.

[0057] Occlusion % = R / R0 (3) Detection of the increased pressure in the catheter fluid path by the pressure sensor 32, such as by the above-described calculation, can alert the user to the possibility of occlusion so that corrective measures can be taken. Further, data storage in a memory location (or other remote storage location) installed on the catheter 10 together with the PCB 36 or remotely installed within the patient's electronic medical record is employed to measure the catheter flushing pressure over time to detect pressure changes over time. This comparison of data over time can be performed for any of the sensors installed on the catheter 10 as can be appreciated. Of course, the data detected by the sensor and stored in the memory location can also be used similarly for a variety of other users, including historical trends and the like.

[0058] Figure 14 depicts various details of a pressure - sensitive syringe 150 that includes a housing 152 defining a cavity 154 together with a distal - end fluid outlet 156. A plunger 158 is disposed within the cavity 154 and is initially disposed in a compressed state and is attached to a spring 160 that can be released by a release button 162 disposed at the proximal end of the syringe 150. When the spring 160 is actuated by the release button 162, a known amount of 0.9% saline 164 or other suitable liquid is disposed within the distal cavity of the plunger 158 so that saline exits from the fluid outlet 156. When the syringe is operably attached to a corresponding Luer connector 20, the saline 164 discharged by the syringe 150 is injected into the extension leg 18 and further passes through the hub 16 and lumen 14 of the catheter tube.

[0059] A pressure sensor 166 is included at the fluid outlet 156 to measure the pressure of a known amount of saline 164 as it exits the fluid outlet 156 and enters the catheter 10 to which the syringe 150 is connected. A processor unit 170 and a display / control unit 172 are included to measure and calculate the pressure that exists when the saline 164 is discharged through the fluid outlet 156 by the plunger 158 (such as by the equation described further above). Further calculations can be performed by the processor unit 170 to determine the hydrodynamic resistance of the injection, whereby the amount of occlusion present within the fluid path of the catheter 10 is obtained using the known amount of saline 164 injected, the injection pressure measured by the pressure sensor 166, and the amount of time required to inject the total amount of saline. In some embodiments, the user can input the size and length of the catheter - tube lumen 14 via the display / control unit 172.

[0060] Results describing the amount of occlusion present in the catheter fluid path (e.g., % of occluded fluid path, etc.) can be depicted on the display / control unit 172 or wirelessly transmitted to a receiving location, for example, via a wireless communication module included in the processor unit 170. Then, if necessary, the user can take corrective measures to be evaluated.

[0061] Note that the historical pressure / occlusion data can be stored at a memory location of the processor unit 170 for retrieval and depiction, for example, by the display / control unit 172. In some embodiments, since the plunger 158 of the syringe 150 can be manually depressed by the user, the need for the spring 160 is eliminated or it can be a pressurized gas source or the like for pushing the plunger. The location of the pressure sensor 166 can also be different from that illustrated and described herein.

[0062] Note that in some other embodiments, the pressure sensor 32 can be used to determine when the catheter tube 12 has become malpositioned within the vascular structure by sensing the pressure difference between the expected value of the correct position and the actual sensed value detected by the pressure sensor. When this situation occurs, the correct measures can be taken to correct the malposition. In some other embodiments, the pressure sensor 32 and the electrical (ECG) sensor 34 can cooperate to detect catheter malposition based on venous pressure display readings and ECG signal analysis.

[0063] FIG. 15 depicts various details of the catheter 10 including the ability to detect occlusions such as the partial occlusion 178 shown at the distal end 13 of the catheter tube 12. As shown, the catheter 10 includes a pressure sensing module 180 operably attached to the luer connector 20 of the catheter 10.

[0064] Syringe 182 is attached to the proximal end of pressure sensing module 180 to effect injection of saline or other suitable fluid through flow lumen 184 of pressure sensing module 180 and into extension leg 18 so as to flow into catheter 10.

[0065] As shown, pressure sensing module 180 includes a pressure indicator 188 in fluid communication with flow lumen 184. Pressure indicator 188 is configured to extend an indicator piece outwardly when a predetermined pressure occurs in flow lumen 184 of the pressure sensing module. Thus, during fluid injection into the system by syringe 182 (or other suitable fluid injector), if a fluid pressure exceeding the predetermined pressure occurs in catheter lumen 14, the pressure buildup reaches proximally to hub 16, extension leg 18, and flow lumen 184, causing the indicator piece of the pressure indicator to extend outwardly, thereby notifying the user of the possibility of an occlusion. It is recognized that indicator pieces of different configurations can be employed. Pressure sensing module 180 can be an individual component attachable to catheter 10, and in some other embodiments, the pressure sensing module is integrally formed with the catheter.

[0066] FIG. 16 depicts possible locations of sensors of sensor array 30 in catheter tube 12. As shown, various sensors 200 of sensor array 30 are disposed proximate distal end 13 of catheter tube 12, along with a pressure sensor 32 disposed proximally to other sensors. FIG. 16 further shows that connection wire 192 extends along the central portion of the catheter tube, for example, within a septum separating lumens 14 from each other, to supply power to sensors 200 of sensor array 30. In some other embodiments, connection wire 192 can be disposed within a dedicated lumen extending the length of the catheter tube. Note that by disposing sensors (here, such as pressure sensor 32, etc.) proximally and spaced apart from distal end 13 of the catheter tube, catheter tube 12 can be cut distally in a cuttable manner.

[0067] FIG. 17 depicts another configuration for including sensor 202 within catheter tube 12, where sensor 202 is disposed on the wall of catheter tube 12 within a skive cut 198 longitudinally defined in the wall. Potting 204, such as thermally conductive epoxy, polyurethane, or RTV potting, is included to cover sensor 202. In some embodiments, sensor 202 includes a glucose sensor for sensing blood glucose levels, and the glucose sensor is not potted such that it is in direct contact with blood. Thus, these and other possible sensor locations are contemplated.

[0068] FIG. 18 depicts another configuration for including a sensor within catheter tube 12, where sensor 202 is disposed on an inner surface of one of the lumens 14 of catheter tube 12, proximate to the distal end 13 of catheter tube 12 or within a septum that divides the lumen space within catheter tube 12 into two or more lumens 14. Potting 204 can be included to insulate and cover sensor 202 as needed. In some embodiments, potting 204 protects sensor 202 from exposure to liquids while allowing heat to be conducted. FIG. 18 further shows that wire-based electrodes 210 can be disposed proximate to the distal end 13 of catheter tube 12 and exposed on the outer surface thereof on the wall of catheter tube 12. Electrodes 210 can be formed as concentrically disposed sensors that can be employed to perform volume measurements to determine the size of the vasculature in which the catheter tube is disposed, thus assisting the user in determining the likelihood of catheter tube positional anomalies in undesired vasculature. Thus, these and other possible sensor configurations are contemplated.

[0069] FIG. 19 depicts various details of a flash sensor 222 for detecting when a desired periodic flushing of catheter 10 with fluid, also referred to herein as the flash state of catheter tube 12, has occurred. As shown, flash sensor 222 is disposed within cavity 220 of luer connector 20 of catheter extension leg 18, although other locations within hub 16 or elsewhere can also be employed for the sensor, and optionally, flash sensor 222 is a thermistor. Flash sensor 222, also referred to herein as a detection module, includes a lever 224 biased to a protruding position by a spring 226, as shown. Flash sensor 222 is operably connected to a processor of a PCB (such as PCB 36 shown in FIG. 10) or other suitable component (e.g., disposed within luer connector 20) to manage its operation and process data sensed thereby.

[0070] During operation, when a syringe or other component is inserted into cavity 220 of luer connector 20 to flush catheter 10 with saline or other suitable fluid, lever 224 of flash sensor 222 is depressed, thereby sending a signal to the processor indicating that a flushing procedure is occurring. Flushing time or other data regarding the flushing procedure can be noted, stored, or used by the processor, or wirelessly transmitted to a receiving location as further described above. In some embodiments, flash sensor 222 and the processor of PCB 36 are referred to as a flash sensor assembly, although it is recognized that the assembly can include additional components. In some other embodiments, an electrical sensor can be employed as the flash sensor, the electrical sensor including a circuit that is broken each time a component is inserted into connector 20. The breaking of the circuit can reset a timer circuit and measure the next period until the flash sensor is activated again.

[0071] In some embodiments, for example, it is desirable for the catheter 10 to be flushed at least every 12 hours. When the flush sensor 222 detects a flushing procedure as described above, the timer circuit in the processor is reset to start counting time and measure the next period until the flush sensor 222 is depressed again to indicate a new flushing procedure.

[0072] FIG. 20 shows that in order to visually indicate the flushing state of the catheter 10, a light array 230 such as an assembly of a red LED light, a yellow LED light, and a green LED light can be included on the surface of the luer connector 20. The green light indicates that less than 10 hours have elapsed since the last flushing procedure was detected, the yellow light indicates that more than 10 hours and less than 12 hours have elapsed since the last flushing procedure, and the red light indicates that more than 12 hours have elapsed since the last flushing procedure. The processor manages the operation of the light array, and it is understood that the lights can vary in number, location, purpose, elapsed time shown, etc. Further, it is recognized that other types of sensors can also be employed, including a sensor that detects the presence of liquid in the luer connector cavity 220 to detect the flushing procedure.

[0073] In some embodiments, the light array 230 can be used as follows. The green light flashes after a satisfactory flushing procedure has been performed, the red light blinks after an unsatisfactory or incomplete flushing procedure has occurred, and the yellow light blinks or is turned on to indicate that there may be a blockage in the catheter tube 12. In some other embodiments, the yellow light (or another light) can be lit to serve as a reminder to flush the catheter 10.

[0074] In some other embodiments, the luer connector 20 or other portions of the catheter 10 can include a push button (or other user-activated component) that can be depressed during flushing of the catheter, thus resetting the timer circuit. In this case, a counting circuit can also be included to count the number of times the connector 20 or other component is accessed.

[0075] FIG. 21 shows that a light array 230 can be disposed at other locations on the catheter 10, including on the hub 16. Thus, for example, these and other possible locations are contemplated, such as the catheter tube or extension leg, or the armband 130 of FIG. 12. In some other embodiments, the light array can be employed to alert the user of other sensed conditions, including elevated body temperature / fever, onset of sepsis (see further below), catheter occlusion, low blood oxygen levels, etc. Further, in addition to the light, other indicia can be employed to alert the user regarding sensor data, including sound, vibration, etc., either at the catheter itself or at a remote receiving location where the data is wirelessly transmitted.

[0076] The flush sensor 222 can similarly be included in other areas, including, for example, a needleless connector configured to be operably mounted to the luer connector. In some embodiments, the pressure sensor 32 can be used (either alone or in cooperation with the flash sensor 222 described above) to detect or characterize a flushing procedure. For example, the flash sensor 222 can be used to detect a flushing procedure, while the pressure sensor 32 can detect the amount of pressure present during the flushing procedure and thus detect the potential for occlusion. In fact, in some embodiments, the pressure sensor 32 is used to determine, for example, the flushing frequency, flushing technique, flushing time, number of catheter accesses, elapsed time since the last catheter access, etc. of the catheter 10 by measuring the pressure in the lumen 14 of the catheter as a function of time using a timer circuitry included on the PCB 36. Such sensor data can be stored, for example, in a memory location provided on the PCB 36 or transmitted to another local or remote receiving location, as has been described. The processing for determining such monitoring can be performed by a processor included on the PCB 36 or remotely.

[0077] In some embodiments, sensor data from catheter sensors such as the pressure sensor 32 and the deep body temperature sensor can be employed to detect a patient's condition such as sepsis. In particular, blood flow rate, respiratory rate, heart rate, and body temperature can be sensed via the pressure sensor 32 and the deep body temperature sensor 100 included in the catheter 10, such as in the configuration illustrated in FIG. 10. These three parameters account for three of the four parameters commonly employed 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 complications from sepsis.

[0078] Figure 22 depicts a sensor-based catheter assembly according to some embodiments. Specifically, catheter 10 is shown with its catheter tube 12 disposed within a patient's vascular structure and two luer connectors 20 operably connected to a supply line 240 configured to both supply fluid to and remove fluid from the catheter's lumen. A pump unit 250 is included to enable movement of fluid through supply line 240. A saline fluid drip assembly 252 is also included to supply fluid to the pump unit for movement through the supply line if needed or desired. A syringe, such as syringe 182, is included to provide additional fluid inlets to corresponding ones of supply line 240.

[0079] Figure 23 depicts further details of the pump unit 250 of Figure 22 and includes a fluid inlet 256A and a fluid outlet 256B configured to operably connect to a corresponding supply line 240 (Figure 22) for introducing blood or other fluid from within the patient's vascular structure through catheter 10 (through fluid inlet 256A) to pump unit 250 and returning the fluid through the catheter (through fluid outlet 256B) to the patient's vascular structure. A pump 258 is included within pump unit 250 to effect movement of the fluid. Additionally, various input ports 260 in fluid communication with fluid inlet 256A are included on pump unit 250 to enable introduction of additional fluids, including heparin, saline, arterial input, etc.

[0080] One or more sensors 262 are also included in pump unit 250 and are arranged to measure one or more physiological aspects of the patient's blood. Examples of such sensors include a blood glucose meter, an oxygen sensor, a lactate sensor, a cardiac output sensor, etc. The location of sensors 262 may be different from that shown herein. Placement of sensors 262 within pump unit 250 rather than on catheter 10 itself enables adoption of relatively large-sized sensors without unduly increasing the size of the catheter.

[0081] Diagnostic System FIG. 24 provides a block diagram of a diagnostic system 2400 that includes a catheter assembly 10 configured for either wired or wireless communication and a console 2402, according to some embodiments. FIGS. 25 and 26 show the diagnostic system 2400 in use with a patient, where the diagnostic system of FIG. 25 is configured for wired communication and the diagnostic system of FIG. 26 is configured for wireless communication.

[0082] 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 single-use disposable device, while the console 2402 and the display screen 2414 are capital equipment for multiple uses. The display screen 2414 can be an integrated display screen integrated with the console 2402 as shown, but the display screen 2414 can alternatively be an individual 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 thereon a GUI including at least the measured temperature associated with one or more sensors 30 of the catheter assembly 10 when the catheter tube 12 is disposed within the patient's vascular structure.

[0083] 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 including the console 2402 and the display screen 2414. In fact, alternatively, the vascular access device can be a cannula or a needle. Thus, 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 is specifically directed to the features of the catheter assembly 10 alone.

[0084] 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 corresponding to the number of lumens or flow paths of the catheter assembly 10, and one or more sensors 30 such as a single temperature sensor (e.g., the temperature sensor 100 of FIG. 9A or FIG. 9B) or multiple sensors (e.g., the temperature sensors 100a, 100b, …, 100n shown in FIG. 24).

[0085] When the vascular access device is a cannula or a needle, the cannula or needle can include one or more of the aforementioned sensors 30. For example, such a vascular access device can have a single temperature sensor configured for temperature measurement therein when disposed within the distal end of its elongate tube and within the patient's vascular structure.

[0086] The catheter tube 12 defines at least one lumen extending between the proximal end and the distal end 13 of the catheter tube 12 as shown in FIG. 1. Together with at least one lumen of the hub 16 and at least one lumen of the extension leg 18, the at least one lumen of the catheter tube 12 defines at least one flow path through the catheter assembly 12. The catheter assembly 10 can be a single lumen catheter assembly 10 such as the single lumen catheter assembly 10 of FIG. 1 having only the aforementioned flow path. Alternatively, the catheter assembly 10 can be a multi-lumen catheter assembly such as the double lumen catheter assembly 10 of FIG. 2 having two flow paths through the catheter assembly 10 or the triple lumen catheter assembly 10 of FIG. 2 having three flow paths through the catheter assembly 10.

[0087] The one or more sensors 30 can include a single temperature sensor (e.g., the temperature sensor 100 of FIG. 9A or FIG. 9B) or multiple temperature sensors (e.g., the temperature sensors 100a, 100b, …, 100n shown in FIG. 24).

[0088] When the catheter assembly 10 has a single temperature sensor 100, the single temperature sensor 100 can be disposed within the catheter tube 12, the hub 16, or the extension leg 18 for temperature measurement therein. For example, as described above with respect to the catheter assembly 10 of FIGS. 9A, 9B or 17, the single temperature sensor 100 can be disposed within the wall of the catheter tube 12. Alternatively, the single temperature sensor 100 can be disposed on or within the septum of the catheter tube 12, as described above with respect to the catheter assembly 10 of FIG. 18. Electrical leads for connecting the single temperature sensor 100 to a power source such as the fixation device 50 or the console 2402 can be disposed as needed within the wall of the catheter tube 12, the septum of the catheter tube 12, or both the wall of the catheter tube 12 and the septum of the catheter tube 12.

[0089] When the catheter assembly 10 has a plurality of temperature sensors 100a, 100b, …, 100n, the plurality of temperature sensors 100a, 100b, …, 100n can be disposed within the catheter tube 12, the hub 16, the extension leg 18, or a combination thereof, and are configured for temperature measurement therein. For example, the catheter tube 12 can include at least one temperature sensor disposed within the catheter tube 12 for temperature measurement within the catheter tube 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 tube 12 and the hub 16 can include at least one temperature sensor disposed therein for temperature measurement.

[0090] As described above with respect to the catheter assembly 10 of FIG. 9A, FIG. 9B or FIG. 17, a temperature sensor such as any of the plurality of temperature sensors 100a, 100b, …, 100n can be disposed within the wall of the catheter tube 12. Alternatively, a temperature sensor such as any of the plurality of temperature sensors 100a, 100b, …, 100n can be disposed on or within the septum of the catheter tube 12, as described above with respect to the catheter assembly 10 of FIG. 18. Combinations of the plurality of temperature sensors 100a, 100b, …, 100n within the wall of the catheter tube 12 and within one or more septa of the catheter tube 12 are also possible. Whether the plurality of temperature sensors 100a, 100b, …, 100n are disposed within the wall of the catheter tube 12, on or within the septum of the catheter tube 12, or a combination thereof, the plurality of temperature sensors 100a, 100b, …, 100n can be disposed intermittently along the length of the catheter tube 12. Disposing each of the plurality of temperature sensors 100a, 100b, …, 100n at different locations along the length of the catheter tube 12 is convenient for measuring the local temperature at different locations. Electrical leads for connecting each of the plurality of temperature sensors 100a, 100b, …, 100n to a power source such as the fixing device 50 or the console 2402 can be disposed as needed within the wall of the catheter tube 12, within the septum of the catheter tube 12, or both within the wall of the catheter tube 12 and within the septum of the catheter tube 12.

[0091] The console 2402 includes a memory 2406 such as a primary memory 2408 and a secondary memory 2410. The primary memory 2408 includes a random-access memory (RAM). The secondary memory 2410 includes a non-volatile memory such as a read-only memory (ROM) having instructions 2412 that are loaded into the primary memory 2408 at runtime of the console 2402 to instantiate a diagnostic process of the console 2402 having one or more functions for processing temperature data from at least one or more sensors 30 while the catheter tube 12 is disposed within the patient's vascular structure (see FIGS. 25 and 26 for an example of the catheter tube 12 disposed within the patient's vascular structure). The instructions 2412 can include those for a 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 can also be for instantiating a display server configured to reconcile an input to the console 2402 and an output from the console 2402. The input to the console 2402 includes the selection of one or more functions of the diagnostic process, such as via a GUI on the display screen 2414. The output of the console 2402 includes the GUI on the display screen 2414.

[0092] The console 2402 is configured to communicate with both the catheter assembly 10 and the display screen 2414 and to supply power to the catheter assembly 10 when the fixation device 50 is not in use. Such communication and power options are shown in FIGS. 24 - 26. For example, the catheter assembly 10 can be wired to the console 2402 by a connector 2416, and the wired connection enables power to be supplied from the console 2402 to the catheter assembly 10 and data (e.g., temperature data) to be supplied from the catheter assembly 10 to the console 2402 (see FIG. 24, connection, option A). In another example, the catheter assembly 10 can have a wireless communication module configured to supply data (e.g., temperature data) to the wireless communication module of the console 2402. Again, in embodiments where wireless communication is used for data transfer, power to the catheter assembly 10 can be supplied by the fixation device 50 (see FIG. 24, connection, option B).

[0093] One or more algorithms for processing temperature data are useful for processing temperature data from the temperature sensors of the catheter assembly 50 in a diagnostic process while the catheter tube 12 is disposed within a patient's vascular structure. For example, one or more temperature data processing algorithms can include an infectious disease diagnostic algorithm for diagnosing an infectious disease within the patient's vascular structure or in subcutaneous tissue. (Other temperature data processing algorithms are described below with respect to certain functions of the diagnostic process.) If the catheter assembly 50 includes a plurality of temperature sensors 100a, 100b, …, 100n disposed at a plurality of locations along the length of the catheter tube 12, the infectious disease diagnostic algorithm can be used by the diagnostic process to diagnose an infectious disease within the patient's vascular structure at any one or more of the plurality of locations along the length of the catheter tube 12. The diagnosis of an infectious disease by the infectious disease diagnostic algorithm follows a local temperature change or trend thereof sensed by one or more of the temperature sensors or a plurality of temperature sensors at one or more of the plurality of locations. For example, an infectious disease can be diagnosed at the insertion site by a rising trend in temperature in the temperature data supplied by a temperature sensor at the proximal end of the catheter tube 12. In another example, sepsis can be diagnosed by a rising trend in temperature in the temperature data supplied by some of the plurality of temperature sensors 100a, 100b, …, 100n along the length of the catheter tube 12.

[0094] One or more functions of the diagnostic process can include a flushing compliance function to ensure flushing compliance after blood is drawn from the catheter assembly 50 and then to ensure the patency of the catheter assembly 50. The flushing 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 by the console 2402, when the expected flushing compliant temperature change does not occur due to flushing the catheter assembly 50 with a room temperature flush fluid or flushing the catheter assembly 50 according to a recommended interval (e.g., every 12 hours) after drawing patient temperature blood from the catheter assembly 50. As described above, the catheter assembly 50 can include at least one temperature sensor disposed within the catheter tube 12 for temperature measurement within the catheter tube 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 tube 12 and the hub 16 for temperature measurement therein. The flushing compliance function is configured to alert when the expected flushing compliant temperature change does not occur at the temperature sensor of the catheter tube 12, the temperature sensor of the hub 16, or both temperature sensors, for example, after patient temperature blood is drawn from the catheter assembly 50 and the catheter assembly 50 is flushed with a room temperature flush fluid.

[0095] One or more functions of the diagnostic process can include a blood flow function. In accordance with the blood flow function, the diagnostic process utilizes a blood flow algorithm to monitor a specific or primary temperature sensor disposed at the distal end of the catheter tube 12 or near some other length of the catheter tube 12. The primary temperature sensor is communicatively coupled to the PID controller of the console 2402, and the PID controller is configured to maintain the primary temperature sensor at a set number of degrees above the blood temperature by issuing a control signal thereto. The amount of electrical power required to maintain the primary temperature sensor at a set number of degrees above the blood temperature is monitored by the blood flow algorithm, for example, by a control signal issued by the PID controller. Since the amount of electrical power required to maintain the primary temperature sensor at a set number of degrees above the blood temperature is proportional to the blood flow, the diagnostic process can utilize the blood flow algorithm to determine the blood flow rate with respect to the primary sensor. The blood flow rate can be used to confirm the initial placement of the catheter tube 12 (or the like) into the blood vessel and proper infusion fluid dilution at the distal end 13 of the catheter tube 12. The blood flow rate can also be used to detect movement of the catheter or occlusion of the blood vessel. Additionally, the blood flow rate can optionally be used in conjunction with an infectious disease diagnostic algorithm to diagnose an infectious disease at the insertion site. A decrease in the blood flow rate at the insertion site is often due to an infection-induced swelling, and thus a decrease in the blood flow rate measured by the blood flow algorithm can serve as an indicator of an infectious disease or a test for diagnosing an infectious disease by the infectious disease diagnostic algorithm.

[0096] If the vascular access device is a cannula or a needle and the single temperature sensor at the distal end of its elongate tube is the primary temperature sensor, the input to the console 2402 includes a maximum value from the blood flow rate data obtained from the blood flow algorithm, and the output from the console 2402 to the GUI includes displaying on the display screen 2414 the successful placement of the distal end of the elongate tube into the patient's vascular structure.

[0097] One or more functions of the diagnostic process can include a cardiac parameter function. In accordance with the cardiac parameter function, the diagnostic process utilizes a blood flow algorithm in combination with a cardiac parameter algorithm to determine cardiac parameters including heart rate and cardiac output. The heart rate can be measured by input from a sensor other than a blood flow variation or temperature sensor. For example, the heart rate can be measured by an ECG stylus or an ECG sensor 34.

[0098] One or more functions of the diagnostic process can include a catheter tracking function. In accordance with the catheter tracking function, the diagnostic process utilizes a blood flow algorithm in combination with a catheter tracking algorithm to determine when the primary temperature sensor advances to the tip of the vascular junction as the blood flow volume increases. The blood flow and changes in blood flow obtained in accordance with the foregoing can be tracked as catheter tracking data, and the diagnostic process can use this 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 to the GUI indicates to the clinician the location of the catheter tube 12 within the patient's vascular structure.

[0099] Furthermore, in accordance with the catheter tracking function, the diagnostic process can be configured to determine a positional abnormality of the catheter tube 12 within the patient's vascular structure according to temperature data from a secondary temperature sensor disposed within the catheter tube 12 proximal to the primary temperature sensor described above. The temperature data from the secondary temperature sensor indicates the patient's blood temperature when the catheter tube 12 is moved against or oriented against the blood flow. The temperature data from the secondary temperature sensor indicates an elevated blood temperature when the catheter tube 12 is moved along the blood flow because the primary temperature sensor is set at a degree above the blood temperature. Information regarding the blood temperature or the elevated blood temperature can be provided as individual or continuous inputs to a display server for output to the GUI of the display screen. The output to the GUI indicates to the clinician a positional abnormality of the catheter tube 12 within the patient's vascular structure.

[0100] Notwithstanding the foregoing, the positional abnormality of the catheter tube 12 can also be determined by a change in blood flow rate near the primary sensor by means of a blood flow rate algorithm. One or more functions of the diagnostic process can include an ECG function for processing ECG data. As described above, the catheter assembly 50 can include an ECG sensor 34. Alternatively, the diagnostic system further includes an electrocardiogram (ECG) stylet configured to be disposed within the catheter tube 12. The ECG function is for processing ECG data from the ECG sensor 34 or the ECG stylet when the catheter tube 12 in which the ECG sensor 34 or the ECG stylet is disposed is disposed within the patient's vascular structure. The ECG function identifies the distal end 13 or the tip location of the catheter tube 12, monitors the movement of the tip of the catheter tube 12, and determines the heart rate or a combination thereof. The ECG function of the diagnostic process can be used to identify the location of the tip of the catheter during catheter placement, monitor the movement of the catheter tip, or measure the heart rate for use in the heart parameter function of the diagnostic process.

[0101] 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 regarding the correlation with infusion data about the patient's response to the infusion of a drug. Thereafter, data on the infusion rate of the drug can be used to perform trend analysis on temperature, blood flow, and cardiac output data, and the aforementioned data can be uploaded to an electronic medical record or a patient database, and further the data can be used together with an artificial intelligence algorithm to improve the treatment of the patient.

[0102] Method The method of the diagnostic system 2400 includes an instantiation step of instantiating a diagnostic process having one or more functions for processing at least temperature data in the memory 2406 (e.g., primary memory 2408) of the console 2402.

[0103] The method also includes a transmission step of transmitting temperature data from the temperature sensor 100 or any of the plurality of temperature sensors 100a, 100b,..., 100n to the console 2402 from the catheter assembly 50. The method also includes a loading step of loading the temperature data into the memory 2406 (e.g., primary memory 2408). The method also includes a processing step of processing the temperature data with the processor 2404 of the console 2402 according to one or more functions for processing the temperature data.

[0104] The method also includes a display step of displaying the measured temperature associated with at least any temperature sensor of the catheter assembly 50 on a GUI on the display screen 2414 configured to communicate with the console 2402 while the catheter assembly 50 is disposed within the patient's vascular structure.

[0105] The method can include a monitoring step of monitoring the blood flow rate near any temperature sensor of the catheter assembly 50 disposed within the patient's vascular structure using a blood flow rate function utilizing a blood flow rate algorithm. Here too, the blood flow rate is proportional to the amount of electrical power required to maintain the temperature of the temperature sensor at a set number of degrees above the blood temperature.

[0106] The diagnostic systems and methods disclosed herein provide clinicians with useful clinical data by integrating sensors into vascular access devices. This eliminates the need to place additional vascular devices in the patient and reduces the patient's risk of infection and other infectious diseases. In addition, the diagnostic systems disclosed herein provide additional data and features such as the quality of blood flow around the vascular device, compliance monitoring of the flushing protocol, and monitoring of the position of the vascular device relative to the vascular junction, which are not currently present in such additional vascular devices already on the market.

[0107] Some specific embodiments are disclosed herein, and while a particular embodiment is disclosed to a certain degree of detail, it is not intended to limit the scope of the concepts provided herein. Those skilled in the art can understand that additional adaptations or modifications can be made in a broader aspect, and these adaptations or modifications are also included. Therefore, embodiments may be practiced that depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A diagnostic system, A catheter assembly, A catheter tube defining at least one lumen extending between a proximal end and a distal end, A hub operably attached to the catheter tube, An extension leg operably attached to the hub, wherein the hub and the extension leg define at least one flow path in fluid communication with the lumen of the catheter tube, the extension leg, A plurality of temperature sensors included in the catheter tube, each temperature sensor of the plurality of temperature sensors being disposed at different locations along the length of the catheter tube to measure local temperature, the plurality of temperature sensors A catheter assembly including, A console configured to communicate with the catheter assembly, the console including a memory and a processor configured to process the temperature data using a diagnostic process having one or more functions for processing at least the temperature data while the catheter tube is disposed within a patient's vascular structure, A display screen configured to communicate with the console, the display screen configured to display a graphical user interface (GUI) including at least the measured temperature associated with the one or more sensors A diagnostic system comprising.

2. The console is configured to instantiate a display server configured to reconcile an input to the console and an output from the console, the input including a selection of the one or more functions of the diagnostic process and the temperature data, and the output including the GUI including at least the measured temperature. The diagnostic system according to claim 1.

3. The memory includes one or more temperature data processing algorithms for processing the temperature data from any of the temperature sensors of the catheter assembly using the diagnostic process while the catheter tube is disposed within the patient's vascular structure. The diagnostic system according to claim 1 or 2.

4. The diagnostic system according to claim 1, wherein the memory includes an infectious disease diagnosis algorithm for diagnosing an infectious disease of the vascular structure or subcutaneous tissue of the patient at any one or more of the plurality of locations along the length of the catheter tube according to a change or trend in the local temperature of the temperature sensor, or according to a change or trend in the local temperature of the temperature sensor at one or more of the plurality of locations.

5. The diagnostic system according to any one of claims 1 to 4, wherein the plurality of temperature sensors includes at least one hub temperature sensor disposed in the hub.

6. The one or more functions of the diagnostic process include a flushing compliance function, and the flushing compliance function is configured to issue a console-based alert when a flushing compliant temperature change as expected from flushing the catheter assembly with room temperature flush fluid after patient body temperature blood is withdrawn from the catheter assembly at recommended intervals or when recommended does not occur in the catheter tube temperature sensor, the hub temperature sensor, or both the catheter tube temperature sensor and the hub temperature sensor. The diagnostic system according to claim 5.

7. The catheter tube includes a primary catheter tube temperature sensor disposed therein, and the console includes a proportional integral derivative (PID) controller communicatively coupled to the primary catheter tube temperature sensor, the PID controller being configured to maintain the primary catheter tube temperature sensor at a set degree above blood temperature. The diagnostic system according to any one of claims 1 to 6.

8. The one or more functions of the diagnostic process include a blood flow function, and the blood flow function is such that the diagnostic process monitors the blood flow near the primary catheter tube temperature sensor for the amount of power required to maintain the primary catheter tube temperature sensor at the set degree above blood temperature using a blood flow algorithm, and the blood flow is proportional to the amount of power required to maintain the primary catheter tube temperature sensor at the set degree above blood temperature. The diagnostic system according to claim 7.

9. The one or more functions of the diagnostic process include a cardiac parameter function, and the cardiac parameter function is such that the diagnostic process uses the blood flow algorithm in combination with a cardiac parameter algorithm to determine cardiac parameters including cardiac output. The diagnostic system according to claim 8.

10. The one or more functions of the diagnostic process include a catheter tracking function, and the catheter tracking function is such that the diagnostic process uses the blood flow algorithm in combination with a catheter tracking algorithm to determine when the primary catheter tube temperature sensor advances to the tip of a vascular junction where vessels merge as the blood flow volume increases. The diagnostic system according to claim 8.

11. The diagnostic process is configured to provide catheter tracking data obtained from the catheter tracking algorithm as a display server input for display server output to the GUI of the display screen, and the display server output to the GUI indicates the location of the catheter tube within the patient's vascular structure to the clinician. The diagnostic system according to claim 10.

12. The catheter tube includes a secondary catheter tube temperature sensor disposed within the catheter tube proximal to the primary catheter tube temperature sensor to determine a positional abnormality of the catheter tube within the vascular structure of the patient. The diagnostic system according to claim 10 or 11.

13. The catheter tracking function is configured to determine a positional abnormality of the catheter according to the temperature data from the secondary catheter tube temperature sensor, and the temperature data from the secondary catheter tube temperature sensor includes the patient's blood temperature when the catheter tube is moved against the blood flow, or the increased blood temperature when the catheter tube is moved along the blood flow due to the primary catheter tube temperature sensor being at the set degree above the blood temperature. The diagnostic system according to claim 12.

14. The diagnostic system according to any one of claims 1 to 13 further includes an electrocardiogram (ECG) stylet or lead embedded in the catheter assembly, and the one or more functions of the diagnostic process are such that when the ECG stylet is disposed within the catheter tube and the catheter tube is disposed within the patient's vascular structure, to confirm the location of the tip of the catheter tube, to monitor the movement of the tip of the catheter tube, to determine the heart rate, or to perform a combination thereof, and includes an ECG function for processing ECG data.

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