CATHETER ASSEMBLY INCLUDING MONITORING CAPABILITIES - Patent application

Abstract

A catheter assembly or elongated tubular device is proposed for use in establishing vascular or other access into the body of a patient. The catheter assembly (10), when deployed within a patient, is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspects of the catheter assembly itself. Such aspects include central venous pressure, body temperature, ECG cardiac signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the capability to wirelessly transmit or otherwise transfer data related to the detected physiological parameters to another location, such as the patient's electronic medical record, a smartphone or other mobile device, a nurse's station, etc. Catheter assemblies configured to detect catheter flushing frequency, flushing quality, etc. are also disclosed.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 233,184, entitled "Catheter Assembly Including Monitoring Capabilities," filed Sep. 25, 2015, which is incorporated by reference in its entirety. [Technical field]

[0002] [Background technology]

[0003] Summary of the Invention

[0004] [Means for solving the problem]

[0005] Briefly summarized, embodiments of the present invention are directed to a catheter assembly or other elongated tubular device for use in establishing vascular or other access within a patient's body. The catheter assembly is equipped with one or more sensors that allow monitoring of one or more physiological aspects or other parameters of the patient and / or physical aspects of the catheter assembly itself or its operation when the catheter assembly is disposed in the patient. Such parameters include central venous pressure, body temperature, ECG cardiac signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise transfer data related to the detected physiological / physical aspects to another location, such as, for example, the patient's electronic medical record, a smartphone or other mobile device, a nurse's station, etc. Catheter assemblies configured to detect catheter flushing frequency, flushing quality, etc. are also disclosed.

[0006] Thus, in one embodiment, a catheter assembly for insertion into a patient's body is disclosed, the catheter assembly comprising an elongated catheter tube defining at least one lumen extending between a proximal end and a distal end, a bifurcation hub operably attached to the catheter tube, and an extension leg operably attached to the bifurcation hub, the bifurcation hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube. At least one sensor is included in the catheter assembly, the at least one sensor configured to detect a physiological aspect of the patient and / or a physical aspect of the catheter assembly. A communication module is also included and configured to wirelessly transmit data sensed by the at least one sensor to a receiving site.

[0007] These and other features of the embodiments of the present invention will become more apparent from the following description and appended claims, or may be learned by the practice of the embodiments of the invention as set forth hereinafter. [Brief description of the drawings]

[0008] The present disclosure will now be described in more detail by reference to certain embodiments that are illustrated in the accompanying drawings. It will be understood that these drawings depict only typical embodiments of the invention and are therefore not to be considered as limiting its scope. Exemplary embodiments of the invention will be described and explained with greater specificity and detail using the following accompanying drawings.

[0009] [Figure 1] FIG. 1 is a plan view of a catheter assembly, according to one embodiment.

[0010] [Diagram 2] FIG. 2 is a plan view of a catheter assembly, according to one embodiment.

[0011] [Diagram 3] FIG. 3 is a plan view of a catheter assembly, according to one embodiment.

[0012] [Figure 4A] 4A-4D are various views of a catheter fixation device according to one embodiment. [Figure 4B] 4A-4B are various views of a catheter fixation device according to one embodiment. [Figure 4C] 4A-4C are various views of a catheter fixation device according to one embodiment.

[0013] [Figure 5A] 5A-5D are various views of a catheter fixation device according to one embodiment. [Figure 5B] 5A-5B are various views of a catheter fixation device according to one embodiment. [Figure 5C] 5A-5C are various views of a catheter fixation device according to one embodiment.

[0014] [Figure 6] FIG. 6 is a perspective view of a catheter assembly, according to one embodiment.

[0015] [Figure 7] FIG. 7 is a partial cross-sectional view of a catheter assembly according to one embodiment.

[0016] [Figure 8A] FIG. 8A shows various views of an ultrasound signal graph. [Figure 8B] FIG. 8B shows various views of an ultrasound signal graph. [Figure 8C] FIG. 8C shows various views of an ultrasound signal graph. [Figure 8D] FIG. 8D shows various views of an ultrasound signal graph.

[0017] [Figure 9A] 9A-9D are various views of a catheter assembly according to one embodiment. [Figure 9B] 9A-9B are various views of a catheter assembly according to one embodiment.

[0018] [Figure 10] FIG. 10 is a partial cross-sectional view of a hub of a catheter assembly according to one embodiment.

[0019] [Figure 11] FIG. 11 is a diagram of a smartphone according to one embodiment.

[0020] [Figure 12] FIG. 12 is a perspective view of a catheter assembly and an auxiliary device according to one embodiment.

[0021] [Figure 13] FIG. 13 is a pressure graph of the catheter assembly.

[0022] [Figure 14] FIG. 14 is a partial cross-sectional view of a pressure sensitive syringe according to one embodiment.

[0023] [Figure 15] FIG. 15 is a partial cross-sectional view of a pressure indicating catheter assembly according to one embodiment.

[0024] [Figure 16] FIG. 16 is a diagram of a distal portion of a catheter assembly according to one embodiment.

[0025] [Figure 17] FIG. 17 is a diagram of a distal portion of a catheter assembly according to one embodiment.

[0026] [Figure 18] FIG. 18 is a perspective view of a distal portion of a catheter assembly according to one embodiment.

[0027] [Figure 19] FIG. 19 is a perspective view of a luer connector according to one embodiment.

[0028] [Figure 20] FIG. 20 is a perspective view of a luer connector of a catheter assembly according to one embodiment.

[0029] [Figure 21] FIG. 21 is a perspective view of a bifurcated hub of a catheter assembly according to one embodiment.

[0030] [Figure 22] FIG. 22 is a simplified diagram of a pump system for use with a catheter according to one embodiment.

[0031] [Diagram 23] FIG. 23 is a side view of the pump unit of the pump system shown in FIG. BEST MODE FOR CARRYING OUT THEINVENTION

[0032] Reference will now be made to the figures, in which similar structure is designated with the same reference designators, and it will be understood that the drawings are diagrammatic and schematic representations of exemplary embodiments of the present invention and are not limited to or necessarily drawn to scale.

[0033] For clarity, it is understood that the term "proximal" refers to a direction relatively closer to a clinician using the devices described herein, while the term "distal" refers to a direction relatively further from the clinician. For example, the end of a catheter that is placed inside a patient's body is considered to be the distal end of the catheter, while the end of the catheter that remains outside the body is the proximal end of the catheter. Also, as used herein, including the claims, the terms "including," "having," and "having" are intended to have the same meaning as the term "comprising."

[0034] Embodiments of the present disclosure are generally directed to catheter assemblies or other elongated tubular devices, together with associated components, for use in establishing vascular or other access into a patient's body. Examples of such catheters include PICCs, central venous catheters, arterial catheters, Foley-type and urinary catheters, peripheral IVs, midline catheters, mid-dwelling catheters, feeding tubes, and the like.

[0035] The catheter assembly or associated components are equipped with one or more sensors that allow for monitoring one or more physiological aspects or other parameters of the patient and / or physical aspects of the catheter assembly itself or its operation. Such aspects include central venous pressure, body temperature, ECG cardiac signals, oxygen levels, ultrasound data, etc. The sensor(s) included in the catheter assembly are positioned to allow for detection of data related to these and / or other parameters. In one embodiment, the one or more sensors are disposed in or proximate to the hub of the catheter assembly, although various other locations are possible. Additionally, other components and structures associated with the catheter assembly, such as, for example, the needleless connector, can include one or more sensors for monitoring physiological / physical aspects.

[0036] Additionally, the catheter assembly includes the capability to wirelessly transmit or otherwise transfer data related to the detected physiological / physical aspects to another location, also referred to herein as a receiving site, examples of which include a patient electronic medical record ("EMR"), a patient monitoring device, a smart phone or other mobile device, a tablet, a storage location, a computer server, a nurse's station, or various other destinations.

[0037] Referring initially to FIG. 1, FIG. 1 depicts various details of a catheter assembly ("catheter"), generally designated 10, according to one embodiment. As shown, the catheter 10 includes an elongated catheter tube 12 defining one or more lumens 14 extending between a proximal end 12A and a distal end 12B of the catheter 10. The proximal end 12A of the catheter tube is operably connected to a bifurcated hub ("hub") 16, which in turn is operably connected to one or more extension legs 18. A connector 20, such as a Luer connector, is disposed on the proximal end of the extension leg 18. The hub 16 includes two suture wings 22 extending in opposite directions from a body of the hub 16. Each suture wing 22 includes a suture hole 24. It should be noted that the hub 16 is also referred to herein as a "bifurcated hub" even if only one fluid passageway is defined therein.

[0038] According to one embodiment, one or more sensors, also referred to herein as a "sensor array" 30, are included in the catheter 10, which enable detection of data related to one or more physiological aspects of the patient and / or physical aspects of the catheter when the catheter tube 12 is disposed in a vasculature (as discussed herein) or other suitable internal portion of the patient's body. In this embodiment, multiple sensors are included in the catheter 10, however, the number, type, size, location, function, and desired use of the various sensors may differ from those shown and described herein. It is noted that the sensor array 30, in one embodiment, may include only one sensor. It is also noted that when only one of a particular sensor is discussed below, it is understood that two or more of a particular type of sensor may be included in the same or different locations within the catheter assembly.

[0039] As shown in FIG. 1, a pressure sensor 32 is included as part of the sensor array 30. In this embodiment, the pressure sensor 32 comprises a central venous pressure ("CVP") sensor, which is disposed to allow the patient's venous pressure to be sensed via fluid (such as blood and / or saline) that is typically present within the lumen 14 of the catheter tube 12. As shown, in this embodiment, the pressure sensor 32 is disposed within the hub 16 so as to be in operative communication with a fluid passageway 26 within the hub that is in turn in fluid communication with the lumen 14 of the single lumen catheter tube 12 shown in FIG. 1. Other pressure sensor locations may also be used, including within the catheter tube 12, within the extension leg 18, and the like. In one embodiment, 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 another embodiment, the pressure sensor comprises a strain-sensing Wheatstone bridge. The sensing surface of the pressure sensor 32 in this embodiment is in direct contact with the fluid present within the fluid passageway of the hub 16. It should be noted that the size, shape, and other configuration of the hub 16 may be increased from that shown and described herein to accommodate the sensor array 30, in one embodiment.

[0040] An ECG sensor 34, also referred to herein as an ECG electrode or electrical sensor, is also included in the catheter assembly, and in one embodiment, the ECG sensor, in conjunction with additional ECG sensors / electrodes located on the patient's skin or external / proximal to the catheter assembly, allows ECG signals emanating from the patient's heart to be detected. As shown, in this embodiment, the ECG sensor 34 is also disposed within the hub 16 such that it is in direct contact with the fluid present in the hub fluid passageway 26 and the lumen 14 of the catheter tube 12. Other ECG sensor locations may also be used, including within the catheter tube 12, within the extension legs 18, etc. In this embodiment, the ECG sensor 34 includes a conductive wire capable of detecting ECG signals of the patient's heart present in the fluid of the hub fluid passageway 26 and the catheter tube lumen 14, although other types of ECG sensors may be used. Further details regarding systems and methods using ECG sensors to guide a catheter assembly to a desired location within a patient's body can be found in U.S. Pat. No. 8,849,382, entitled "Apparatus and Display Methods Relating to Intravascular Placement of a Catheter," which is incorporated herein by reference in its entirety.

[0041] As described, the sensor array 30, here including a pressure sensor 30 and an ECG sensor 34, is disposed within the hub 16, which is sized to provide the necessary volume for such sensors. It should be noted that the size, shape, and other configuration of the hub 16 may vary from that shown and described herein to accommodate the sensor(s). In other embodiments, the sensors may be located in other portions of the catheter 10, including along the catheter tube 12 or at either end of the catheter tube 12, in the extension leg(s) 18, etc. It should be noted that a variety of sensors, some of which are discussed further below, may be included in the catheter assembly to detect body measurements, physiological aspects of the patient, and / or physical aspects of the catheter.

[0042] FIG. 1 further illustrates that the hub 16 (or other suitable location) includes a printed circuit board ("PCB") 36 configured to manage the operation of the sensor array 30, here including a pressure sensor 32 and an ECG sensor 34. In one embodiment, the PCB 36 includes a microprocessor for managing sensor operation. In one embodiment, the PCB 36 can further include a power supply for powering the sensor array 30, although in other embodiments the power supply can be disposed remotely from the PCB and even from the catheter 10. Non-volatile memory storage locations, such as, for example, flash memory, can also be included in the PCB 36, allowing data sensed by the sensors of the sensor array 30 to be stored therein, either temporarily or permanently. The storage locations can be accessible by a user or can be transmitted to a desired location in the manner described below.

[0043] In this embodiment, the PCB 36 further includes a transmission module, such as a wireless communication, to enable the PCB to wirelessly transmit the sensor data to another receiving site, such as those mentioned above. Such wireless transmission may be via Bluetooth, Wi-Fi, radio frequency, near field communication ("NFC"), GPS, ANT, ZigBee, or other methods utilizing electromagnetic radiation. In another embodiment, the sensor data may be transmitted from the catheter 10 via a physical connection, such as via a removable physical connection, wire, or the like. In another embodiment, and as described above, the sensor data, e.g., central venous pressure, ECG signal, temperature, etc., is stored in a memory location included in the PCB 36 or elsewhere in the catheter 10. In yet another embodiment, the PCB 36 includes a clock / timer circuit.

[0044] In the present embodiment of FIG. 1, the suture holes 24 of the suture wings 22 are configured to include electrical contacts to provide power to the sensors 30 and 34 of the sensor array 30 and the PCB 36. In particular, an annular electrical contact 40 is included in each suture hole 24 of the suture wings 22 of the bifurcation hub, with the electrical contacts operably connected to the PCB 36 and the sensor array 30. A fixation device, such as the fixation device 50 shown in FIGS. 4A-4C, is configured to be placed on the patient's skin and operably couple to the catheter 10 and secure the catheter in place once the distal portion of the catheter has been inserted into the patient. To that end, the fixation device 50 includes a retainer 54 attached to an adhesive pad and a fixation arm that is hinged to releasably pivot (in a snap-fit ​​arrangement) atop the suture wings 22 of the bifurcation hub 16 to secure the bifurcation hub in place.

[0045] In this embodiment, the fixation device 50 includes additional functionality to provide power to the sensor array 30 and the PCB 36. In particular, the fixation device 50 includes two posts 58 configured to function as electrical contacts 60, each of which is operably connected to a battery 62 also included in the fixation device. The posts 58 are configured to be received in 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 in the fixation device 50 can thus provide power to the sensors 32, 34 and the PCB 36 of the catheter hub 16. Of course, other external power sources can be used. In one embodiment, electrical contacts between the catheter and the fixation device can also be utilized to transfer sensor data between them. In another embodiment, the fixation device can include a wireless or other mode for transmitting sensor data received from the catheter. In yet another embodiment, the PCB or the sensor can be included in the fixation device. It is understood that the size, shape, and other configurations of the fixation device can vary from those shown and described herein.

[0046] 5A-5C depict details of a retention device 50 according to another embodiment, where the retention device includes a pod 70 including a PCB and a battery for use with the sensor array 30 included in the catheter 10, for example, thereby eliminating the need for the PCB and / or battery to be disposed on the catheter 10 itself. FIGS. 5A and 5C show that the pod 70 includes electrical contacts 60 on the top surface of the holder 54, where the electrical contacts 60 are configured to make electrical contact with corresponding electrical contacts on the hub 16 of the catheter 10. Thus, when the hub 16 is removably held by the retention arm 56 of the retention device 50, the sensor array 30 is powered and managed by the battery and PCB of the pod 70. In one embodiment, the pod 70 is configured to be removable from the retention device 50, thus making the pod reusable in a subsequent retention device. This can be useful when the catheter 10 and / or retention device 50 are replaced. In this manner, the pod 70, including the PCB, battery, and / or one or more sensors, etc., can be removed from the anchoring device and placed in another location, thus saving resources and costs. Note that the battery and PCB may be disposed in other locations as well. These and other variations are therefore contemplated. Further details regarding catheter anchoring devices related to those described herein may be found in U.S. Patent No. 6,770,055, entitled "Universal Catheter Anchoring System," which is incorporated herein by reference in its entirety.

[0047] Additionally, in one embodiment, the fixation device 50 may include an ECG sensor (e.g., electrodes) that may cooperate with the ECG sensor 34 of the catheter 10, thus allowing dual ECG signals to be detected and used to determine the proximity of the distal end 12B of the catheter tube 12 to the heart. This configuration may also be used to determine malposition of the distal end 12B of the catheter tube, both during initial catheter placement and subsequently during placement of the catheter within the patient. In one embodiment, sensor data from the pressure sensor 30 may also be used in conjunction with the ECG signal to further detect malposition of the distal end of the catheter tube.

[0048] Figures 2 and 3 show dual and triple lumen catheter configurations, respectively, as opposed to the single lumen configuration of Figure 1. Like that of the catheter of Figure 1, the catheters 10 shown in Figures 2 and 3 each include a sensor array 30 similar to that shown in Figure 1, including corresponding pressure sensors 32, ECG sensors 34, and PCBs 36. Also shown are electrical contacts 40 for electrical connection to electrical contacts 60 of fixation device 50 (Figures 4A-4C). Note that each extension leg 18 of catheter 10 of Figures 2 and 3 includes a corresponding one of pressure sensors 32 such that pressure data can be sensed at each extension leg. In other embodiments, more or fewer sensors than those illustrated herein may be used to sense physiological aspects of the patient and / or physical aspects of the catheter assembly, including, for example, lactate sensors, oxygen sensors, ultrasound components, GPS position sensors, temperature sensors, sizing sensors for measuring intraluminal diameter, fluid velocity sensors, glucose meters, oxygen sensors, lactate sensors, cardiac output sensors, accelerometers, blood volume and cardiac output sensors, and the like.

[0049] Figure 6 depicts a catheter 10 according to one embodiment including three pressure sensors 32 at specific locations on corresponding extension legs 18 and an ECG sensor 34 disposed on one extension leg, each sensor operatively connected to a PCB 36 disposed within the hub 16. Figure 5 thus demonstrates that the number, type, and placement of the sensor(s) and PCBs may vary from that previously shown and described.

[0050] FIG. 7 depicts a detailed view of a sensor-equipped catheter 10 according to one embodiment, in which the hub 16 includes an ultrasound assembly 80 with upper and lower PCBs 82A and 82B configured to control ultrasound transducers 84A and 84B, respectively. As shown in FIGS. 8A-8D, the ultrasound transducers 84A and 84B can be used to ultrasonically evaluate a fluid passageway, or lumen 92, of the bifurcated hub 16 to determine the contents of the lumen. For example, FIG. 8A shows that when air is present in the lumen 92, no ultrasound signal is present, as depicted in ultrasound signal graph 90 of FIG. 8A. In contrast, when a fluid, such as Fluid A, is present in the lumen 92, the ultrasound transducers 84A and 84B return signals of a particular voltage consistent with the composition of Fluid A, as seen in graph 90 of FIG. 8B. If fluid B, which has a different composition than fluid A, is present in lumen 92, ultrasonic transducers 84A and 84B will return a particular voltage signal consistent with the composition of fluid B, as seen in graph 90 of FIG. 8C. Also, if both fluid and air are present in lumen 92, graph 90 of FIG. 8D shows that a fluctuating voltage signal is detected by ultrasonic transducers 84A and 84B. In this manner, as further described above, ultrasonic transducers 84A and 84B coupled to a battery and PCB can assist a user in determining the presence of a particular substance in lumen 92 of ultrasonic transducer hub 16, or in the lumen of other catheter components, depending on the placement of the ultrasonic transducer. In another embodiment, only a single ultrasonic transducer is used.

[0051] 9A and 9B depict details of a sensor-equipped catheter 10 according to another embodiment, where the hub 16 includes a PCB 82 and is operatively connected to a temperature sensor 100, such as a thermocouple in one embodiment, positioned to measure core body temperature via blood or other fluid present within the catheter lumen 14. As shown in FIG. 9B, the temperature sensor 100 may be placed proximate to the lumen 14 via a milling or cavity 108 defined longitudinally within the catheter tube 12 and / or hub 16. Potting 106 may be used to fill the cavity 108 around the temperature sensor 100. In one embodiment, the temperature sensor 100 includes a Series 400 Model 401 thermistor available from Cole-Palmer Inc., Vernon Hills, Ill.

[0052] FIG. 10 illustrates that in one embodiment, various sensors may be included as part of a sensor array 30 within the hub 16 or other suitable location. As depicted in FIG. 10, in one embodiment, the hub 16 includes disposed therein 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. The various sensors are positioned proximate to the fluid passageway 26 of the hub 16 as needed to sense relevant parameters detected in the fluid present within the fluid passageway. The specific placement of the sensors may vary from that shown herein.

[0053] FIG. 11 illustrates that in one embodiment, a smartphone 120 can be a receiving site for wirelessly receiving data from one or more sensors of the sensor array, as in the embodiment described above. Examples of wireless modes by which data can be transmitted include Bluetooth, Wi-Fi, radio frequency, near field communication (NFC), ANT, ZigBee, etc. Such data transmission can be relayed through a software-based application or other intermediary device. This allows a clinician to receive mobile updates and other sensor data 124 from the catheter 10 via the display 122 of the smartphone 120 (or by other mediums including sound, vibration, etc.) so that the clinician can monitor the progress or condition of the patient. Other locations for receipt of sensor data as described above include the patient's electronic medical record ("EPR"), patient monitoring equipment, electronic tablets and other mobile devices including laptop computers, electronic storage locations, computer servers, nurses' stations, medical equipment such as pumps attached to the catheter, and various other destinations. It is understood that devices, components, computers, etc. located at the receiving site can perform operations on the received data, including analysis, trending, alarm functions, etc.

[0054] FIG. 12 depicts a catheter 10 according to another embodiment, where the catheter is shown inserted into a patient's arm 128 such that the majority of the catheter tube 12 is disposed within the patient's vasculature. The hub 16, including one or more sensors, is also shown operatively connected to an auxiliary device, such as an arm band 130, positioned around the patient's arm 128 via a connecting wire 134. Although the arm band 130 is positioned adjacent to an external portion of the catheter 10 in this embodiment, in other embodiments, its location and specific shape, size, configuration, and body attachment manner may vary. As shown, the arm band 130 includes various components that cooperate with the sensor(s) of the catheter 10 via the connecting wire 134, including the PCB 36 and a wireless communication module 136 (included in the PCB in other embodiments). Sensor data detected by the sensor(s) of the catheter 10 can be transferred from the catheter 10 via connecting wires 134 to components of the armband 130, where the data can be processed (e.g., by the PCB 36) and / or transmitted to a remote location (e.g., by the wireless communication module 136). In another embodiment, the operative connection between the catheter 10 and the armband 130 can be: It is also a wireless connection.

[0055] The placement of the PCB 36 and wireless communication module 136 on the armband 130 frees up space on the catheter and obviates 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 wireless communication module 136 can begin to function with the new catheter as they did with the previous catheter. It is noted that the armband 130 may also include various other components, such as a battery for powering the sensor(s) included in the catheter, additional sensors including an ECG sensor, etc. As mentioned above, the armband 130 represents other wearable and non-wearable auxiliary devices that may be operatively connected to the sensor(s) of the catheter 10 to facilitate their operation. It is also noted that the components included in the armband / auxiliary device may be replaceable / reusable in one embodiment. In one embodiment, the PCB, battery, and / or wireless communication module may be included in the catheter fixation device. In another embodiment, the above components may be included on a platform that may be removably attached to the armband. In another embodiment, the armband or similar component includes a disposable shield to separate it from the patient and / or provide isolation from contaminants.

[0056] Some of the above embodiments include a pressure sensor 32 configured to sense data related to the central venous pressure of the patient in which the catheter 10 is disposed. In another embodiment, the data sensed by the pressure sensor 32 may be further used to detect when an obstruction, such as a fibrin sheath or a thrombus, may be present in the lumen 14 of the catheter tube 12. FIG. 13 shows a pressure graph 140 including a pressure curve 142 depicting the pressure level over time in the catheter tube lumen 14 sensed by the pressure sensor 32, such as in the pressure sensor configuration of FIG. 10 during a flushing procedure, where a user flushes fluid through the catheter 10 using a syringe connected to the luer connector 20 to maintain patency of the catheter tube lumen 14. As shown, the pressure curve 142 includes various pressure peaks 144 caused by the user pulsating the syringe at moments of applied pressure. This is done to clear any trace obstructions that may form in the catheter tube lumen 14 or other areas of the catheter fluid path. If an occlusion is present within the distal end 12B and / or lumen 14 of the catheter tube (see, e.g., occlusion 178 in FIG. 15), the pressure curve 142 will be elevated (i.e., shifted vertically upward along the pressure y-axis) or widened (i.e., lengthened along the time x-axis).

[0057] 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) As for R, R = t1 ∫ t2 P dt / V, (2)

[0058] Note that in the formula, V is the known volume 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 P denotes the instantaneous pressure at each moment of the fluid injection procedure. By comparing the resistance R of fluid injection through the catheter tube 12 at a particular time (using the above equation) and comparing it to a previous resistance R0, such as when the catheter 10 was first inserted into the patient and deemed unoccluded or patent, one can obtain a percentage of possible occlusion in the catheter tube according to: Blockage%=R / R0 (3)

[0059] Detection of high pressure in the catheter fluid path by pressure sensor 32, such as via the calculations described above, can alert the user to a possible blockage so that necessary action can be taken. Additionally, data storage in memory located on catheter 10 with PCB 36 or remotely located in the patient's electronic medical record (or other remote storage location) can be used to measure catheter flushing pressure over time to detect pressure changes over time. This comparison of data over time can be performed for any one of the sensors located on catheter 10, as can be appreciated. Of course, the data sensed by the sensors and stored in memory can be used for a variety of other applications as well, including historical trending, and the like.

[0060] 14 depicts various details of a pressure sensitive syringe 150 according to one embodiment, including a housing 152 defining a cavity 154 having a distal fluid outlet 156. A plunger 158 is disposed within the cavity 154 and is initially disposed in a compressed state and attached to a spring 160 that is releasable 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 disposed within the cavity distal to the plunger 158 such that when the spring 160 is actuated by the release button 162, the saline exits through the fluid outlet 156. The saline 164 expelled by the syringe 150 is injected into the extension leg 18 and then through the hub 16 and lumen 14 of the catheter tube when the syringe is operably attached to a corresponding luer connector 20.

[0061] A pressure sensor 166 is included in the fluid outlet 166 to measure the pressure of the 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 (e.g., further via the equations above) the pressure present when the saline 164 is expelled by the plunger 158 through the fluid outlet. Using the known volume of saline 164 injected, the injection pressure measured by the pressure sensor 166, and the amount of time required to inject all of the saline, further calculations are performed by the processor unit 170 to determine the hydrodynamic resistance of the injection and therefore the amount of occlusion present in the fluid path of the catheter 10. In one embodiment, a user can input the size of the catheter tube lumen 14 and its length via the display / control unit 172.

[0062] Results depicting the amount of any obstruction present in the catheter flow path (such as, for example, the percentage of the flow path that is obstructed) can be displayed on the display / control unit 172 or can be wirelessly transmitted to a receiving site, for example, via a wireless communication module included in the processor unit 170. If necessary, the user can take necessary action.

[0063] It should be noted that in one embodiment, the pressure / occlusion history data may be stored by a memory location in the processor unit 170, for example, for recall and depiction by the display / control unit 172. In one embodiment, the plunger 158 of the syringe 150 may be manually depressible by a user, thus eliminating the need for a spring 160, or a source of pressurized gas to depress the plunger, etc. The location of the pressure sensor 166 may also vary from that shown and described herein.

[0064] In another embodiment, the pressure sensor 32 can be used to determine when the catheter tab 12 becomes malpositioned within the vasculature by detecting the pressure difference between an expected value for proper placement and the actual detected value detected by the pressure sensor. When this occurs, appropriate steps can be taken to correct the malposition. In another embodiment, the pressure sensor 32 and the electrical (ECG) sensor 34 can work in concert to detect catheter malposition based on venous pressure readings and ECG signal analysis.

[0065] 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 12B of the catheter tube 12, according to one embodiment. As shown, the catheter 10 includes a pressure sensing module 180 operably attached to the luer connector 20 of the catheter 10. A syringe 182 is attached to the proximal end of the pressure sensing module 180 to provide an injection of saline or other suitable fluid through a fluid lumen 184 of the pressure sensing module 180 and into the extension leg 18 to flow through the catheter 10.

[0066] As shown, the pressure sensing module 180 includes a pressure indicator 188 in fluid communication with the fluid lumen 184. The pressure indicator 188 is configured to extend an indicator component outwardly when a predetermined pressure is created in the fluid lumen 184 of the pressure sensing module. In this manner, when a fluid pressure exceeding a predetermined pressure is created in the catheter lumen 14 during fluid injection into the system with the syringe 182 (or other suitable fluid injection device), the pressure increase extends through the hub 16, the extension leg 18, and the fluid lumen 184, causing the indicator component of the pressure indicator to extend outwardly, thus indicating to the user that an occlusion may be present. It is understood that indicator components of different configurations may be used. In this embodiment, the pressure sensing module 180 is a separate component that is attachable to the catheter 10, while in other embodiments, the pressure sensing module is integrally formed with the catheter.

[0067] FIG. 16 illustrates possible locations of the sensors of the sensor array 30 within the catheter tube 12. As illustrated, the various sensors 200 of the sensor array 30 are disposed proximate the distal end 12B of the catheter tube 12 with the pressure sensor 32 disposed proximate the other sensors. FIG. 16 further illustrates that the connecting wires 192 extend along the central portion of the catheter tube, for example within the bulkheads that separate the lumens 14 from one another, to power the sensors 200 of the sensor array 30. In another embodiment, the connecting wires 192 can be disposed within a dedicated lumen that extends the length of the catheter tube. It should be noted that the placement of the sensor(s) at a distance proximate the catheter tube distal end 12B, such as the pressure sensor 32 herein, allows the catheter tube 12 to be distally cuttable.

[0068] 17 depicts another configuration for including a sensor 200 in the catheter tube 12, where the sensor 200 is disposed in the wall of the catheter tube 12 within a skive cut 198 defined longitudinally in the wall. A potting 204, such as a thermally conductive epoxy, polyurethane, or RTV potting, is included to cover the sensor 200. In one embodiment, the sensor 200 includes a glucose sensor for sensing blood glucose levels, where the glucose sensor is not implanted such that it is in direct contact with the blood. Thus, these and other possible sensor locations are contemplated.

[0069] FIG. 18 depicts another configuration for including a sensor in the catheter tube 12, where the sensor 200 is disposed on the inner surface of one of the lumens 14 of the catheter tube 12 proximate the distal end 12B of the catheter tube 12. Potting 204 may be included to insulate and cover the sensor 200, if desired. In one embodiment, the potting 200 prevents the sensor 200 from being exposed to liquid while allowing heat to be transferred through the liquid. FIG. 18 further illustrates that a wire-based electrode 210 may be disposed on the wall of the catheter tube 12 proximate the distal end 12B of the catheter tube 12 so as to be exposed on the outer surface of the catheter tube 12. The sensor 210 may be formed as a concentrically disposed sensor that may be used to perform volumetric measurements to determine the size of the blood vessel in which the catheter tube is disposed, thus aiding the user in determining possible malpositioning of the catheter tube within an undesired vessel. Thus, these and other possible sensor configurations are contemplated.

[0070] 19 depicts various details of a flush sensor 222 for detecting when a desired periodic flushing of the catheter 10 with fluid has occurred, also referred to herein as a flush state of the catheter tube 12. As shown, the flush sensor 222 is disposed within a cavity 220 of the luer connector of the catheter extension leg 18, although other locations for the sensor may be used. The flush sensor 222, also referred to herein as a detection module, includes a lever 224 biased to an extended position by a spring 226, as shown. The flush sensor 222 is operatively connected to a processor on a PCB (e.g., PCB 36 shown in FIG. 10) or other suitable component (e.g., disposed within the luer connector 20) to govern its operation and process its sensed data.

[0071] 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 a flushing procedure is occurring. The time of flushing or other data related to the flushing procedure may be recorded, stored, or used by the processor, or may be wirelessly transmitted to a receiving site in a manner similar to that discussed above. In one embodiment, the flush sensor 222 and the processor of the PCB 36 are referred to as a flush sensor assembly, although it is understood that this assembly may include additional components. In another embodiment, an electrical sensor may be used as the flush sensor, which includes a circuit that is disconnected each time a component is inserted into the connector 20. The disconnection of the circuit may reset a timer circuit to time the next period until the flush sensor is activated again.

[0072] In one embodiment, for example, it is desirable for catheter 10 to be flushed at least once every 12 hours. When flush sensor 222 detects a flushing procedure as described above, the timing circuitry within the processor is reset and begins timing to measure the next time period until flush sensor 222 is pressed again, indicating a new flushing procedure.

[0073] 20 illustrates that in one embodiment, a light array 230, such as a collection of red, yellow, and green LED lights, may be included on the surface of the luer connector 20 to visually indicate the flushing status of the catheter 10, with green light indicating that less than 10 hours have passed since the last flushing procedure was detected, yellow light indicating that more than 10 hours but less than 12 hours have passed since the last flushing procedure, and red light indicating that more than 12 hours have passed since the last flushing procedure. It is understood that a processor manages the operation of the light array, and that the lights can vary in number, size, location, purpose, elapsed time to indicate, etc. Additionally, it is understood that other types of sensors that detect the presence of liquid within the luer connector cavity 220 may also be used to detect a flushing procedure.

[0074] In another embodiment, the light emitter array 230 may be used as follows: a green light flashes after an acceptable flushing procedure has been performed, a red light blinks after an unacceptable or incomplete flushing procedure has been performed, and a yellow light blinks or is illuminated to indicate that a possible blockage is present in the catheter tube 12. In yet another embodiment, a yellow light (or other light) may be illuminated to act as a cue to flush the catheter 10.

[0075] It will be appreciated that in another embodiment, the luer connector 20 or other portion of the catheter 10 can include a push button (or other user controlled component) that can be depressurized upon flushing of the catheter, thereby resetting a 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.

[0076] 21 illustrates that the light array 230 may be disposed in other locations on the catheter 10, including, in this embodiment, on the hub 16. These and other possible locations are also contemplated, such as on the catheter tube or extension leg, or, for example, on the armband 130 of FIG. 12. In other embodiments, the light array may be used to alert the user to other sensed conditions, including elevated body temperature / fever, onset of sepsis (see further below), catheter blockage, low blood oxygen levels, etc. Additionally, in addition to lights, other indications, including sound, vibration, etc., may be used to alert the user to sensor data, either on the catheter itself or at a remote receiving site to which the data is wirelessly transmitted.

[0077] It should be noted that the flush sensor 222 may be included in other areas as well, including, for example, a needleless connector configured to operably attach to a luer connector.

[0078] In one embodiment, the pressure sensor 32 can be used alone or in conjunction with the flush sensor 222 described above to detect and / or characterize a flushing procedure. For example, in one embodiment, the flush sensor 222 can be used to detect a flushing procedure, while the pressure sensor 32 can sense the amount of pressure present during the flushing procedure, thereby detecting possible occlusions. Indeed, in one embodiment, the pressure sensor 32 can be used to determine the flushing frequency, flushing technique, flushing time, number of catheter accesses, time since last catheter access, etc. of the catheter 10 by measuring the pressure in the catheter lumen 14 as a function of time, for example, using a timer circuit included on the PCB 36. Such sensor data can be stored, for example, by a memory location located on the PCB 36, or transmitted to another local or remote receiving site, as mentioned. Processing for determining such monitoring can be performed by a processor included on the PCB 36 or remotely located.

[0079] In one embodiment, sensor data from catheter sensors, such as pressure sensor 32 and core temperature sensor, can be used to detect a patient condition, such as sepsis. In particular, respiratory rate, heart rate, and body temperature can be sensed via pressure sensor 32 and core temperature sensor 100 included in catheter 10, such as in the configuration shown in FIG. 10. These three parameters comprise three of four parameters typically used to determine the onset of sepsis. Thus, monitoring of these parameters via catheter 10 described herein can be used, in one embodiment, to prevent, detect, and ameliorate complications from sepsis.

[0080] 22 depicts a sensor-based catheter assembly according to another embodiment. In particular, a catheter 10 is shown with its catheter tube 12 disposed within the patient's vasculature and two luer connectors 20 operably connected to supply lines 240 configured to both provide fluid to and remove fluid from the lumen of the catheter. A pump unit 250 is included to allow fluid to move through the supply lines 240. A saline drip assembly 252 is also included to provide fluid to the pump unit if needed or desired. A syringe, such as syringe 182, is included to provide an additional fluid inlet in a corresponding one of the supply lines 240.

[0081] FIG 23 depicts further details of the pump unit 250 of FIG 22, including a fluid inlet 256A and a fluid outlet 256B configured to operatively connect with a corresponding supply line 240 (FIG 22) to bring blood or other fluid from within the patient's vasculature to the pump unit 250 via the catheter 10 (through the fluid inlet 256A) and return the fluid to the patient's vasculature via the catheter (through the fluid outlet 256B). A pump 258 is included within the pump unit 250 to effect the movement of fluid. Additionally, various input ports 260 are included on the pump unit 250 in fluid communication with the fluid inlet 256A to allow additional fluids to be input, including heparin, saline, arterial input, etc.

[0082] One or more sensors 200 are also included within the pump unit 250 and positioned to measure one or more physiological aspects of the blood in the patient. Examples of such sensors include glucose sensors, oxygen sensors, lactate sensors, cardiac output sensors, etc. The location of the sensor 200 may vary from that shown herein. The placement of the sensor 200 in the pump unit 250, as opposed to placement on the catheter 10 itself, allows a relatively large sized sensor to be used without unduly increasing the size of the catheter.

[0083] The embodiments of the present invention may be embodied in other specific forms without departing from the spirit of the present disclosure. The described embodiments should be construed in all respects as merely illustrative and not restrictive. The scope of the embodiments is therefore defined by the appended claims, rather than the above description. All changes that come within the meaning and range of equivalence of the claims are embraced within their scope. The invention as originally claimed in the present application is set forth below. [1] A catheter assembly for insertion into a patient's body, comprising: an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end; a bifurcated hub operably attached to the catheter tube; an extension leg operatively attached to the bifurcation hub, the bifurcation hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube; at least one sensor included in the catheter assembly, the at least one sensor configured to detect at least one of a physiological aspect of the patient and a physical aspect of the catheter assembly; a communications module configured to wirelessly transmit data sensed by the at least one sensor to a receiving location. [2] The catheter assembly described in [1], wherein the communication module is included on a printed circuit board, and the printed circuit board is included in the catheter assembly. [3] The catheter assembly of [1], wherein the receiving location includes a smartphone, a storage device, a patient electronic medical record, a mobile device, a computer server, a laptop computer, a nurse's station, and a printer. [4] The catheter assembly described in [1], wherein the at least one sensor includes a pressure sensor, an oxygen sensor, a temperature sensor, an ultrasound transducer, an electrical sensor configured to detect an ECG signal, and a glucose sensor. [5] A catheter assembly as described in [1], wherein the at least one sensor and the printed circuit board are disposed within the branch hub. [6] The catheter assembly described in [1], wherein the communication module is configured to transmit the data detected by the at least one sensor via at least one of Bluetooth, Wi-Fi, near-field communication, and radio frequency signals. [7] The catheter assembly described in [1], wherein the at least one sensor is configured to detect when the catheter assembly is flushed with fluid. [8] The catheter assembly described in [7], wherein the at least one sensor includes a flash sensor configured to be activated when a component is operably connected to the catheter assembly. [9] The catheter assembly described in [8], wherein the flash sensor includes a lever configured to be displaced when the component is operably connected to the catheter assembly.

[10] The catheter assembly described in [9], wherein the flash sensor is included within at least one of a Luer connector and a needleless connector included in the catheter assembly.

[11] The catheter assembly described in

[10] , further comprising a pressure sensor configured to operate with the flush sensor to detect when the catheter assembly is flushed with fluid.

[12] The catheter assembly described in [1], further comprising at least one light emitter disposed on the catheter assembly, the light emitter configured to operate together with the at least one sensor to alert a user regarding an aspect of the at least one sensor.

[13] The catheter assembly described in [1], further comprising a pressure sensor and a temperature sensor, the pressure sensor and the temperature sensor configured to detect the patient's respiratory rate, heart rate, and body temperature to determine whether a septic condition exists.

[14] The catheter assembly described in [1], further comprising a battery configured to power at least one of the at least one sensor and the printed circuit board included in the catheter assembly.

[15] The catheter assembly described in

[14] , wherein the battery is contained within a fixation device configured to be attached to a skin surface of the patient, and the fixation device is configured to removably secure the catheter assembly to the patient.

[16] The catheter assembly described in

[15] , wherein the fixation device includes first and second electrical contacts configured to operably connect with corresponding electrical contacts of the catheter assembly.

[17] A catheter assembly for insertion into a patient's body, comprising: an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end; a bifurcated hub operably attached to the catheter tube; an extension leg operatively attached to the bifurcation hub, the bifurcation hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube; a plurality of sensors included in the catheter assembly and configured to detect at least one of a physiological aspect of the patient and a physical aspect of the catheter assembly, at least one of the sensors including an electrical sensor configured to detect an ECG signal of the patient's heart; a communications module configured to wirelessly transmit data sensed by the plurality of sensors.

[18] The catheter assembly described in

[17] , wherein the electrical sensor is contained within the hub.

[19] The catheter assembly described in

[17] , wherein the electrical sensor is disposed in a wall of the catheter tube adjacent the distal end of the catheter tube.

[20] The catheter assembly described in

[17] , further comprising a battery configured to power at least one of the plurality of sensors and at least one of the printed circuit boards included in the catheter assembly.

[21] The catheter assembly described in

[20] , wherein the battery is contained within a fixation device configured to be attached to a skin surface of the patient, and the fixation device is configured to removably secure the catheter assembly to the patient.

[22] The catheter assembly described in

[21] , wherein the fixation device includes first and second electrical contacts configured to operably connect with corresponding electrical contacts of the catheter assembly.

[23] A catheter assembly for insertion into a patient's body, comprising: an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end; at least one sensor included in the catheter assembly, the at least one sensor configured to detect at least one of a physiological aspect of the patient and a physical aspect of the catheter assembly; and and an auxiliary device disposed remotely from the catheter tube, the auxiliary device operably attached to the at least one sensor, the auxiliary device configured to provide assistance to the at least one sensor in detecting the at least one of the physiological aspect of the patient and the physical aspect of the catheter assembly.

[24] A catheter assembly as described in

[23] , wherein the auxiliary device is configured to be worn on the patient's body or clothing.

[25] The catheter assembly described in

[23] , wherein the auxiliary device includes at least one removable or reusable component.

[26] The catheter assembly described in

[23] , wherein the auxiliary device includes a printed circuit board and a battery, the printed circuit board and the battery being operably connected to the at least one sensor of the catheter assembly via a connecting wire.

[27] The catheter assembly described in

[23] , wherein the auxiliary device includes a wireless communication module.

[28] The catheter assembly described in

[23] , wherein the auxiliary device includes an armband.

[29] A catheter assembly for insertion into a patient's body, comprising: an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end; a pressure indicator disposed within a fluid passage associated with the catheter assembly, the pressure indicator configured to move from a first position to a second position when a predetermined fluid pressure is present within the fluid passage.

[30] The catheter assembly described in

[29] , wherein the pressure indicator is contained within a pressure detection module that is removably attached to the catheter assembly, and the pressure detection module includes the fluid passage.

[31] The catheter assembly described in

[30] , wherein the pressure detection module is configured to be sandwiched between a proximal end of the catheter assembly and a syringe, and the syringe is configured to be operatively connected to the fluid passage of the pressure detection module.

[32] A catheter assembly for insertion into a patient's body, comprising: an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end; a bifurcated hub operably attached to the catheter tube; an extension leg operatively attached to the bifurcation hub, the bifurcation hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube; at least one sensor included in the catheter assembly, the at least one sensor configured to detect a physical aspect of the catheter assembly; and a communications module configured to wirelessly transmit data sensed by the at least one sensor to a receiving location.

[33] The catheter assembly according to

[32] , wherein the physical aspect includes a state of occlusion of the catheter tube.

[34] The catheter assembly described in

[33] , wherein the at least one sensor includes a pressure sensor.

[35] The catheter assembly described in

[32] , wherein the physical aspect includes a flushing state of the catheter tube and the at least one sensor includes a flush sensor.

[36] The catheter assembly described in

[32] , wherein the at least one sensor includes a pressure sensor and the physical aspect includes an abnormality in position of the distal end of the catheter tube.

[37] The catheter assembly of

[36] , further comprising an ECG sensor configured to assist in detecting the malposition of the distal end of the catheter tube.

[38] A catheter flush sensor assembly for detecting fluid flushing of a lumen of a catheter tube inserted into a patient's body, comprising: a detection module configured to detect when a medical component is at least indirectly operably connected to the catheter tube; a processor configured to process data associated with the detection of the at least indirect connection of the medical component to the catheter tube.

[39] The catheter flush sensor assembly described in

[38] , wherein the detection module includes a flush sensor disposed within a cavity of a luer connector of the catheter assembly, the flush sensor configured to be activated when a medical component is received within the cavity of the luer connector.

[40] A catheter flush sensor assembly as described in

[39] , wherein the flush sensor includes a lever biased to a first position by a spring, the lever being movable to a second position when the medical component is received within the cavity of the luer connector.

Claims

1. 1. A catheter assembly for insertion into a patient's body, comprising: an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end; two or more sensors included in the catheter assembly configured to detect at least one of a physiological aspect of a patient and a physical aspect of the catheter assembly when fluid is present in the at least one lumen; an extension leg in fluid communication with the at least one lumen of the catheter tube, the extension leg having each of the sensors operably connected thereto via a connecting wire; an auxiliary device disposed remotely from the catheter tube, operably connected to each of the sensors via the connecting wires, and configured to assist each of the sensors in detecting at least one of the physiological aspect of the patient and the physical aspect of the catheter assembly; A catheter assembly, wherein each of the sensors is disposed on the extension leg.

2. The catheter assembly of claim 1 , wherein the auxiliary device is configured to be worn on the patient's body or clothing.

3. The catheter assembly of claim 1 , wherein the auxiliary device includes at least one removable or reusable component.

4. The catheter assembly of claim 1 , wherein the auxiliary device includes a printed circuit board and a battery, the printed circuit board and the battery operatively connected to each of the sensors via the connecting wires.

5. The catheter assembly of claim 1 , wherein the auxiliary device includes a wireless communication module.

6. The catheter assembly of claim 1 , wherein the auxiliary device includes an arm band.

Images