Catheter assembly with monitoring function

Abstract

The invention relates to a catheter assembly with a monitoring function. A catheter assembly or other elongate tubular device for establishing a vascular or other access within a body of a patient is provided. The catheter assembly is equipped with one or more sensors that allow monitoring one or more physiological aspects of the patient or physical aspects of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG cardiac signals, oxygen content, ultrasound data, glucose, and the like. The catheter assembly has functionality for wirelessly transmitting or otherwise forwarding data related to the detected physiological parameter to another location, such as a patient electronic medical record, a smartphone or other mobile device, a nurse station, and the like. Catheter assemblies configured to detect catheter irrigation frequency, irrigation quality, and the like are also disclosed.

Description

[0001] Case division information

[0002] This application is a divisional application of the invention patent application with application number 202111026810.0 filed on September 23, 2016 and invention name “Catheter assembly with monitoring function”, which is in turn a divisional application of the invention patent application with application number 201680055380.6 filed on September 23, 2016 and invention name “Catheter assembly with monitoring function”.

[0003] Cross-references to Related Patent Applications

[0004] This patent application claims the benefit of U.S. Provisional Patent Application No. 62 / 233,184, filed September 25, 2015, and entitled “Catheter Assembly Including Monitoring Capabilities,” which is incorporated herein by reference in its entirety. Summary of the Invention

[0005] In short, embodiments of the present invention relate to the catheter assembly or other elongated tubular devices for setting up blood vessel or other access in patient body.This catheter assembly is equipped with one or more sensors, and when catheter assembly is arranged in patient body, described one or more sensors allow monitoring patient's one or more physiological aspects or other parameters and / or catheter assembly itself or the physical aspect of its operation.Such parameters comprise central venous pressure, body temperature, ECG heart signal, oxygen content, ultrasonic data, glucose etc.The catheter assembly has the function that is used for the data wireless transmission relevant to detected physiological / physical aspect or otherwise forwarded to another position (for example, patient's electronic medical record, smart phone or other mobile device, nurse station etc.).The present invention also discloses catheter assembly, this catheter assembly is configured to detect catheter flushing frequency, flushing quality etc.

[0006] Therefore in one embodiment, disclose the conduit tube assembly for inserting in patient's body, this conduit tube assembly comprises elongated catheter body, and this elongated catheter body is limited at least one lumen extending between proximal end and distal end; The shunt hub that is operably attached to conduit tube body; And the extension leg that is operably attached to shunt hub, described shunt hub and extension leg limit at least one fluid channel that is communicated with at least one lumen fluid of conduit tube body.At least one sensor is included together with conduit tube assembly, and described at least one sensor is configured to detect the physiological aspects and / or the physical aspects of conduit tube assembly of patient.Also comprise communication module, it is configured to be transmitted to receiving position by the data wireless that at least one sensor is sensed.

[0007] These and other features of the embodiments of the present invention will become more fully 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] A more particular description of the present disclosure will be given by reference to specific embodiments of the present disclosure shown in the accompanying drawings. It should be recognized that these drawings only illustrate typical embodiments of the present invention and are therefore not to be considered as limiting its scope. Exemplary embodiments of the present invention will be described and explained in more detail through the use of the accompanying drawings, in which:

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

[0010] Figure 2 is a plan view of a catheter assembly according to one embodiment;

[0011] Figure 3 is a plan view of a catheter assembly according to one embodiment;

[0012] Figures 4A to 4C are various views of a catheter securing device according to one embodiment;

[0013] Figures 5A to 5C are various views of a catheter securing device according to one embodiment;

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

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

[0016] Figures 8A to 8D It is various views of ultrasonic signal diagram;

[0017] Figure 9A and Figure 9B are various views of a catheter assembly according to one embodiment;

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

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

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

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

[0022] Figure 14 is a partial cross-sectional view of a pressure sensing syringe according to one embodiment;

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

[0024] Figure 16 is a view of a distal portion of a catheter assembly according to one embodiment;

[0025] Figure 17 is a view of a distal portion of a catheter assembly according to one embodiment;

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

[0027] Figure 19 is a perspective view of a Luer connector according to one embodiment;

[0028] Figure 20 is a perspective view of a Luer connector of a catheter assembly according to one embodiment;

[0029] Figure 21 is a perspective view of a shunt hub of a catheter assembly according to one embodiment;

[0030] Figure 22 is a simplified illustration of a pump system for use with a catheter, according to one embodiment; and

[0031] Figure 23 yes Figure 22 A side view of a pump unit of the pump system is shown. DETAILED DESCRIPTION

[0032] Referring now to the drawings, wherein like structures will have like reference numerals, it should be understood that the drawings are diagrammatic and representative of exemplary embodiments of the invention and are not limiting of the invention and are not necessarily drawn to scale.

[0033] For the sake of clarity, it should be understood that the word "proximal" refers to a direction relatively closer to a clinician using the device to be described herein, while the word "distal" refers to a direction relatively away from the clinician. For example, the end of a catheter placed in a patient's body is considered to be the distal end of the catheter, while the end of the catheter remaining outside the body is the proximal end of the catheter. In addition, the words "including" and "having" as used herein (including the claims) should have the same meaning as the word "comprising".

[0034] Embodiments of the present disclosure generally relate to catheter assemblies or other elongated tubular devices used, together with associated components, to establish a vascular or other access route within a patient's body. Examples of such catheters include PICCs, central venous catheters, arterial catheters, Foley-type and urinary catheters, peripheral intravenous catheters, indwelling catheters, feeding tubes, and the like.

[0035] Conduit tube assembly or related parts are equipped with one or more sensors, and when conduit tube assembly was arranged in the patient, described one or more sensors allowed to monitor one or more physiological aspects or other parameters and / or conduit tube assembly itself or the physical aspects of its operation of the patient.This type of aspect comprises central venous pressure, body temperature, ECG heart signal, oxygen content, ultrasonic data etc.The sensor that is included with conduit tube assembly is arranged to so that allow to detect the data relevant to these and / or other parameters. In one embodiment, described one or more sensors are arranged in or near the hub of conduit tube assembly, but also can adopt various other positions. In addition, other parts associated with conduit tube assembly and structure (such as needleless connector) can comprise one or more sensors that are used to monitor physiological / physical aspects.

[0036] In addition, the catheter assembly has the functionality to wirelessly transmit or otherwise forward data related to the detected physiological / physical aspects to another location, also referred to herein as a receiving location. Examples of data receiving locations include a patient electronic medical record ("EMR"), a patient monitoring device, a smartphone or other mobile device, a tablet computer, a storage location, a computer server, a nurse's station, or various other destinations.

[0037] First reference Figure 1 , which shows various details of a catheter assembly ("catheter") generally designated 10 according to one embodiment. As shown, the catheter 10 includes an elongated catheter body 12, which defines one or more lumens 14 extending between its proximal end 12A and distal end 12B. The proximal end 12A of the catheter body is operably connected to a shunt hub ("hub") 16, which in turn is operably connected to one or more extension legs 18. A connector 20 (e.g., a Luer connector) is provided on the proximal ends of the extension legs 18. The hub 16 includes two suture wings 22 extending in opposite directions from the 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 as a "shunt hub" herein, even when only one fluid channel is defined therethrough.

[0038] According to one embodiment, one or more sensors are included with catheter 10, these sensors are also referred to as " sensor array " 30 in this article, when catheter tube body 12 is arranged in the vascular system of patient's health (as described herein) or other suitable inner part, allow to detect the data relevant to the physical aspect of one or more physiological aspects and / or catheter of patient.In the present embodiment, a plurality of sensors are included with catheter 10, but the number, type, size, arrangement, function and the desired use of each sensor can be different with shown and described in this article.It should be noted that in one embodiment, sensor array 30 can comprise only a sensor.Also should be noted that, although only a specific sensor is discussed hereinafter, it should be appreciated that the same or different positions in the catheter assembly can comprise more than one specific type sensor.

[0039] like Figure 1 As shown, a pressure sensor 32 is included as part of the sensor array 30. In the present embodiment, the pressure sensor 32 comprises a central venous pressure ("CVP") sensor and is configured to allow for sensing of the patient's venous pressure via the fluid (e.g., blood and / or saline) typically present in the lumen 14 of the catheter tube 12. As shown, in the present embodiment, the pressure sensor 32 is disposed within the hub 16 so as to be in operable communication with the fluid channel 26 within the hub, which in turn is in communication with the catheter tube 12. Figure 1 The lumen 14 of the single lumen catheter body 12 is shown to be in fluid communication. Other pressure sensor locations may also be used, including extension legs 18, etc. within the catheter body 12. In one embodiment, the pressure sensor 32 is a medical pressure sensor NPC-100 or NPC-120 manufactured by Amphenol Corporation, but other pressure sensors may also be used. In another embodiment, the pressure sensor includes a strain-sensitive Wheatstone bridge. The sensing surface of the pressure sensor 32 in this embodiment is in direct contact with the fluid present in the fluid channel of the hub 16. It should be noted that in one embodiment, the size, shape and other configurations of the hub 16 may be larger than shown and described herein to accommodate the sensor array 30.

[0040] In one embodiment, ECG sensor 34 (also referred to as ECG electrode or electrical sensor in this article) is also included with catheter assembly, in conjunction with other ECG sensor / electrode that is positioned at patient's skin or catheter assembly external part / near catheter assembly, allows ECG signal to pass from patient's heart to be detected.As shown in the figure, in the present embodiment, ECG sensor 34 is also arranged in hub 16, so that directly contact with the fluid in the lumen 14 that is present in hub fluid channel 26 and catheter tube body 12.Other ECG sensor positions can also be adopted, and it comprises extension leg 18 etc. in catheter tube body 12.In the present embodiment, ECG sensor 34 comprises conduction line, and this conduction line can detect the patient's heart ECG signal that is present in the fluid in hub fluid channel 26 and catheter tube body lumen 14, but also can adopt other types of ECG sensors. Additional details regarding systems and methods for guiding a catheter assembly to a desired location within a patient's body using an ECG sensor can be found in U.S. Patent 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 above, the sensor array 30 (here including the pressure sensor 30 and the ECG sensor 34) is disposed within the hub 16, which can be sized to provide the required volume for such sensors. It should be noted that the size, shape, and configuration of the hub 16 can vary from that shown and described in order to accommodate the sensors. In other embodiments, the sensors can be located in other portions of the catheter 10, including extension legs 18, etc., along the catheter tubing 12 or at either end of the catheter tubing. It should also be noted that various sensors for detecting body measurements, physiological aspects of the patient, and / or physical aspects of the catheter can be included with the catheter assembly, some of which will be discussed further below.

[0042] Figure 1Also shown, the hub 16 (or other suitable location) includes a printed circuit board ("PCB") 36 that is configured to control the operation of the sensor array 30, which here includes a pressure sensor 30 and an ECG sensor 34. In one embodiment, the PCB 36 includes a microprocessor for controlling the operation of the sensors. In one embodiment, the PCB 36 may also include a power supply for powering the sensor array 30, but in other embodiments, the power supply may be located remotely from the PCB, or even remotely from the catheter 10. A non-volatile memory storage location (such as flash memory) may also be included on the PCB 36 to allow data sensed by the sensors of the sensor array 30 to be temporarily or permanently stored thereon. The storage location may be accessible by a user or may be transferred to a desired location as described below.

[0043] In the present embodiment, PCB 36 also includes a transmission module, such as a radio component that allows PCB to wirelessly transmit sensor data to another receiving location (such as those further described above). Such wireless transmission can be carried out by Bluetooth, Wi-Fi, radio frequency, near field communication ("NFC"), GPS, ANT, ZigBee or other modes utilizing electromagnetic radiation. In another embodiment, the sensor data can be transmitted from the catheter 10 via a physical connection, such as via a removable physical connection, line, etc. In another embodiment, as previously described, the sensor data (such as 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. In yet another embodiment, PCB 36 includes a clock / timer circuit.

[0044] exist Figure 1 In the present embodiment, 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. Specifically, each suture hole 24 of the shunt hub suture wings 22 includes an annular electrical contact 40 therein, wherein the electrical contacts are operatively connected to the PCB 36 and the sensor array 30. Figures 4A to 4C The illustrated securing device 50 is configured to be positioned on the patient's skin once the distal portion of the catheter 10 is inserted into the patient's body and to be operatively coupled to the catheter and to secure it in place. To this end, the securing device 50 includes a retainer 54 mounted to an adhesive pad and a securing arm that is hinged so as to removably pivot (using a snap-fit arrangement) on top of the suture wings 22 of the shunt hub 16 to secure the shunt hub in place.

[0045] In this embodiment, the fixture 50 includes the additional functionality of providing power to the sensor array 30 and PCB 36. Specifically, the fixture 50 includes two cylindrical members 58, each configured to function as an electrical contact 60 and each operably connected to a battery 62, which is also contained within the fixture. The cylindrical members 58 are configured to be received in corresponding suture holes 24 of the catheter suture wings 22, establishing electrical contact through the electrical contacts 40 of the suture holes. The battery 62, thus included in the fixture 50, can provide power to the sensors 32, 34 and the PCB 36 of the catheter hub 16. Of course, other external power sources may be employed. In one embodiment, the electrical contacts between the catheter and the fixture can also be utilized to transmit sensor data between the two. In another embodiment, the fixture can include a radio or other means for transmitting sensor data received from the catheter. In another embodiment, the PCB or sensors can be included within the fixture. It should be appreciated that the size, shape, and other configurations of the fixture may vary from those shown and described herein.

[0046] Figures 5A to 5C Details of a fixture 50 according to another embodiment are depicted, wherein the fixture includes a pod 70 that includes a PCB and battery for use with, for example, a sensor array 30 included in a catheter 10. This eliminates the need to provide the PCB and / or battery on the catheter 10 itself. Figure 5A and Figure 5C As shown, pod 70 includes electrical contacts 60 on the upper surface of retainer 54, wherein the electrical contacts are configured to electrically connect to corresponding electrical contacts on hub 16 of catheter 10. Thus, when hub 16 is removably retained by retaining arm 56 of fixture 50, sensor array 30 is powered and controlled by the battery and PCB of pod 70. In one embodiment, pod 70 is configured to be removable from fixture 50, allowing it to be reused with a subsequent fixture. This may be useful when replacing catheter 10 and / or fixture 50. Thus, pod 70, including the PCB, battery, and / or one or more sensors, can be removed from the fixture and placed in another location, saving resources and costs. It should also be noted that the battery and PCB can also be located in other locations. These and other variations are contemplated. Further details regarding catheter fixtures related to those described herein can be found in U.S. Patent 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 can include an ECG sensor (e.g., an electrode) that can cooperate with the ECG sensor 34 of the catheter 10, thereby allowing dual ECG signals to be detected and used to determine the distance of the distal end 12B of the catheter tube 12 relative to the heart. This configuration can also be used to determine misalignment of the catheter tube distal end 12B during initial catheter placement and subsequent placement of the catheter in the patient. In one embodiment, sensor data from the pressure sensor 30 can also be used in conjunction with the ECG signal to further detect misalignment of the catheter tube distal end.

[0048] and Figure 1 Compared with the single lumen structure, Figure 2 and Figure 3 Double and triple lumen catheter configurations are shown, respectively. Figure 1 The structure is the same as Figure 2 and Figure 3 The catheters 10 shown each include Figure 1 A similar sensor array 30 is shown, including corresponding pressure sensors 32, ECG sensors 34 and PCB 36. Also shown are electrical contacts 60 ( Figures 4A to 4C ) Electrical contacts 40 for electrical connection. Note that Figure 2 and Figure 3 Each extension leg 18 of the mid-catheter 10 includes a corresponding one of the pressure sensors 32 so that pressure data can be sensed in each extension leg. In other embodiments, more or fewer sensors than shown here can be used to sense physiological aspects of the patient and / or physical aspects of the catheter assembly, including, for example, lactate sensors, oxygen sensors, ultrasonic element portions, GPS location sensors, size sensors for measuring the inner diameter of the lumen, fluid velocity sensors, blood glucose meters, cardiac output sensors, accelerometers, blood volume and cardiac output sensors, etc.

[0049] Figure 6 A catheter 10 is depicted according to one embodiment, the catheter including three pressure sensors 30 in designated locations of respective extension legs 18 and an ECG sensor 34 disposed in one extension leg, wherein each sensor is operably connected to a PCB 36 disposed in the hub 16. FIG5 thus illustrates that the number, type, and arrangement of sensors and PCBs may vary from that shown and described.

[0050] Figure 7Detail of a sensor-equipped catheter 10 is depicted according to one embodiment, wherein the hub 16 includes an ultrasound assembly 80 comprising an upper PCB 82A and a lower PCB 82B configured to control ultrasonic transducers 84A and 84B, respectively. Ultrasonic transducers 84A and 84B can be used to ultrasonically evaluate a fluid channel or lumen 92 of the shunt hub 16 to determine the contents of the lumen, such as Figures 8A to 8D For example, Figure 8A As shown, when air is present in the lumen 92, there is no ultrasonic signal. Figure 8A The ultrasonic signal is shown in FIG90. In contrast, if a fluid (such as fluid A) is present in lumen 92, ultrasonic transducers 84A and 84B return a signal of a specified voltage that is consistent with the composition of fluid A, as determined by Figure 8B If fluid B, which has a different composition than fluid A, is present in lumen 92, ultrasonic transducers 84A and 84B return signals of a specified voltage that corresponds to the composition of fluid B, as determined by Figure 8C When there is both fluid and air in the lumen 92, Figure 8D Graph 90 shows the changing voltage signals detected by ultrasonic transducers 84A and 84B. Thus, ultrasonic transducers 84A and 84B, coupled to a battery and PCB as described further above, can help a user determine the presence of a specific substance within the lumen 92 of hub 16 or within the lumen of other catheter components (depending on the placement of the ultrasonic transducers). In another embodiment, only a single ultrasonic transducer is employed.

[0051] Figure 9A and 9B Detail of a sensor-equipped catheter 10 according to another embodiment is depicted, wherein the hub 16 includes a PCB 82 disposed therein and operably 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 in the lumen 14 of the catheter. Figure 9B As shown, the temperature sensor 100 can be placed adjacent to the lumen 14 (via shaving) or cavity 108 longitudinally defined in the catheter tubing 12 and / or hub 16. An encapsulant 106 can be used to fill the cavity 108 about the temperature sensor 100. In one embodiment, the temperature sensor 100 comprises a Series 400 Model 401 thermistor available from Cole-Palmer Inc., Vernon Hills, IL.

[0052] Figure 10As shown, in one embodiment, each sensor may be included in the hub 16 or other suitable location as part of a sensor array 30. Figure 10 As depicted, 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), an upper ultrasonic transducer 84A and a lower ultrasonic transducer 84B, a temperature sensor 100, and an oxygen sensor 110. Each sensor is positioned adjacent to the fluid channel 26 of the hub 16 as desired to sense relevant parameters detected in the fluid present in the fluid channel. The specific arrangement of the sensors may vary from that shown here.

[0053] Figure 11 As shown, in one embodiment, the smart phone 100 can be a receiving location for wirelessly receiving data from one or more sensors of the sensor array, as described in the above embodiments. Examples of wireless modes that can be used to transmit data include Bluetooth, Wi-Fi, radio frequency, near field communication (NFC), ANT, ZigBee, etc. The data transmission can be relayed by a software-based application or other intermediate device. This allows the clinician to receive mobile updates and other sensor data 124 from the catheter 10 via the display screen 122 of the smart phone 120 (or through other media, including sound, vibration, etc.) so that the patient's progress or condition can be monitored. As described above, other locations for receiving sensor data include patient electronic medical records ("EPR"), patient monitoring devices, other mobile devices including electronic tablets and laptops, electronic storage locations, computer servers, nurse stations, medical devices such as pumps attached to catheters, and various other destinations. It should be appreciated that the devices, components, computers, etc. located at the receiving location can perform operations on the received data, including analysis, trend prediction, alarm functions, etc.

[0054] Figure 12Described conduit 10 according to another embodiment, wherein shown is the arm 128 of catheter insertion patient, so that the major part of conduit body 12 is arranged in the patient's vascular system.Also shown is the hub 16 that comprises one or more sensors, this hub is operably connected to auxiliary device, such as arm band 130, and this arm band is arranged around patient's arm 128 via connecting line 134.In the present embodiment, arm band 130 is arranged near the outer part of conduit 10, but its position and concrete shape, size, construction and attachment scheme can be different in other embodiments.As shown in the figure, arm band 130 comprises various parts to cooperate the sensor work of conduit 10 via connecting line 134, and these parts comprise PCB 36 and wireless communication module 136 (this wireless communication module is included with PCB in other embodiments).The sensor data detected by the sensor of conduit 10 can be forwarded to the parts of arm band 130 from conduit 10 via connecting line 134, wherein can process data (for example, by PCB 36) and / or data are transmitted to distal position (for example, by wireless communication module 136). In another embodiment, the operable connection between the catheter 10 and the armband 130 may also be 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 can prevent the need to replace relatively expensive components if the catheter 10 itself is periodically replaced with a new one. In this case, the armband 130 can be directly connected to the new catheter, and the PCB 36 and wireless communication module 136 can be used to initiate the new catheter's use just as with the previous one. It should be noted that the armband 130 may also include various other components, including a battery for powering sensors included with the catheter, additional sensors including an ECG sensor, and so on. As described, the armband 130 is representative of other wearable and non-wearable auxiliary devices that can be operably connected to the sensors of the catheter 10 to facilitate their operation. It should also be noted that, in one embodiment, the components included on the armband / auxiliary device are replaceable / reusable. In one embodiment, the PCB, battery, and / or wireless communication module may be included on the catheter fixture. In another embodiment, these components may be included on a platform that is removably attached to the armband. In another embodiment, the armband or similar component includes a disposable cover to isolate it from the patient and / or provide contaminant isolation.

[0056] Several of the above-described embodiments include a pressure sensor 32 configured to sense data related to the central venous pressure of a patient in whom the catheter 10 is disposed. In another embodiment, the data sensed by the pressure sensor 32 can be used to detect a possible occlusion within the lumen 14 of the catheter tubing 12, such as a fibrous sheath or a thrombus. Figure 13A pressure graph 140 is shown including a pressure curve 142 depicting the pressure level over time in the catheter tubing lumen 14 during a flushing procedure, as sensed by the pressure sensor 32, such as Figure 10 The pressure sensor is constructed in such a way that during this flushing process, the user uses a syringe connected to the Luer connector 20 to flush the fluid through the catheter 10 to maintain the openness of the catheter body lumen 14. As shown, the pressure curve 142 includes several pressure peaks 144, which are formed when the user pulses the syringe to apply additional pressure. This operation is performed to clear micro-emboli that may have formed in the catheter body lumen 14 or other areas of the catheter fluid path. If an occlusion exists in the distal end 12B of the catheter body and / or in the lumen 14 (see, for example, Figure 15 If there is an occlusion 178 in the pressure curve 142, the pressure curve 142 will rise (ie, move vertically upward along the pressure y-axis) or become wider (ie, become longer along the time x-axis).

[0057] More specifically, the hydraulic resistance R of a fluid is generally related to the fluid flow rate Q and the injection pressure P by the following relationship:

[0058] P = Q * R, (1)

[0059] This formula yields:

[0060] R = t1 ∫ t2 P dt / V, (2)

[0061] Where V is the known volume of fluid to be injected into the catheter 10, t1 is the start time of the fluid injection process, and t2 is the end time of the fluid injection process (refer to Figure 13 ), noting that P indicates the instantaneous pressure at each moment of the fluid injection process. Comparing the resistance to fluid injection through catheter 12 for a certain period of time, R (using the above formula) and comparing it with the resistance R0 at a previous time, such as when catheter 10 was first inserted into the patient and was considered unoccluded or patent, the percentage of possible occlusion in the catheter tubing can be obtained according to the following formula:

[0062] % occlusion = R / R0 (3)

[0063] Detection of elevated pressure in the catheter fluid path via pressure sensor 32, such as via the calculations described above, can alert the user to a possible occlusion, allowing corrective action to be taken. Additionally, data storage located in a memory location 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 irrigation pressure over time to detect pressure changes over time. It should be appreciated that this data comparison over time can be performed for any of the sensors located on catheter 10. Of course, the data sensed by the sensors and stored in the memory location can also be used for a variety of other purposes, including historical trending, etc.

[0064] Figure 14 Various details of a pressure sensing syringe 150 according to one embodiment are depicted, including a housing 152 defining a cavity 154 with a distal end fluid outlet 156. A plunger 158 is disposed within the cavity 154 and is attached to a spring 160, which is initially compressed and releasable via a release button 162 disposed on the proximal end of the syringe 150. A known amount of 0.9% normal saline 164 or other suitable liquid is disposed in the cavity distal to the plunger 158, such that the saline flows out of the fluid outlet 156 when the spring 160 is actuated by the release button 162. When the syringe is operably attached to a corresponding luer connector 20, the saline 164 ejected from the syringe 150 is injected into the extension legs 18 and then passes through the hub 16 and the lumen 14 of the catheter tubing.

[0065] A pressure sensor 166 is included on the fluid outlet 156 to measure the pressure of a known amount of saline 164 as it flows out of the fluid outlet 156 and into 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 (such as via the formula further described above) the pressure present when the saline 164 is ejected by the plunger 158 through the fluid outlet. Additional calculations can be performed by the processor unit 170 to determine the hydraulic resistance to injection, thereby deriving the amount of occlusion present in the fluid path of the catheter 10 using the known volume of saline 164 injected, the injection pressure measured by the pressure sensor 166, and the amount of time required to perform all the saline injections. In one embodiment, the user can input the size of the catheter tubing lumen 14 and its length via the display / control unit 172.

[0066] Results describing the amount of any occlusion present in the catheter fluid path (such as as a percentage of the fluid path that is occluded) may be depicted on the display screen / control unit 172 or wirelessly transmitted to a receiving location via, for example, a wireless communication module included with the processor unit 170. Corrective action may then be taken by the user as needed.

[0067] Note that in one embodiment, historical pressure / occlusions can be stored in a memory location of the processor unit 170, for example, for recall and display via the display screen / control unit 172. In one embodiment, the plunger 158 of the syringe 150 can be manually depressed by the user, thereby obviating the need for the spring 160, or a pressurized gas source can be used to push the plunger. The location of the pressure sensor 166 can also vary from that shown and described herein.

[0068] It is noted that, in another embodiment, the pressure sensor 32 can be used to determine if the catheter tubing 12 has been misplaced within the vasculature by sensing the pressure difference between the expected value for correct placement and the actual value detected by the pressure sensor. When this occurs, corrective steps can be taken to correct the misplacement. In another embodiment, the pressure sensor 32 and the electrical (ECG) sensor 34 can collaborate to detect catheter misplacement based on venous pressure readings and ECG signal analysis.

[0069] Figure 15 Various details of a catheter 10 capable of detecting occlusions according to one embodiment are depicted, such as a partial occlusion 178 shown at the distal end 12B of the catheter tubing 12. As shown, the catheter 10 includes a pressure detection 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 detection module 180 to provide an infusion of saline or other suitable liquid through a flow lumen 184 of the pressure detection module 182 and into the extension leg 18 to flow through the catheter 10.

[0070] As shown, the pressure detection module 180 includes a pressure indicator 188 in fluid communication with the flow lumen 184. The pressure indicator 188 is configured to extend an indicator device outward when a predetermined pressure is encountered in the flow lumen 184 of the pressure detection module. Thus, during the injection of fluid into the system via the syringe 182 (or other suitable fluid injection device), when the catheter lumen 14 encounters a fluid pressure exceeding the predetermined pressure, the pressure accumulation extends proximally through the hub 16, the extension leg 18, and the flow lumen 184, causing the indicator device of the pressure indicator to extend outward, thereby indicating to the user that there may be an occlusion. It should be appreciated that indicator devices of different configurations may be used. In this embodiment, the pressure detection module 180 is a separate component that can be attached to the catheter 10; in other embodiments, the pressure detection module is formed integrally with the catheter.

[0071] Figure 16Depicted are possible locations of sensors of sensor array 30 within catheter tubing 12. As shown, each sensor 200 of sensor array 30 is positioned proximate distal end 12B of catheter tubing 12, along with pressure sensor 32 positioned proximal to the other sensors. Figure 16 Also shown is a connecting wire 192 that extends along a central portion of the catheter conductor (e.g., at the septum separating the lumens 14 from one another) to power the sensors 200 of the sensor array 30. In another embodiment, the connecting wire 192 can be disposed within a dedicated lumen extending the length of the catheter tube. Note that the placement of sensors (such as the pressure sensor 32 in this example) at a distance proximal to the distal end 12B of the catheter tube allows the catheter tube 12 to be distally adjustable.

[0072] Figure 17 Another configuration for including a sensor 200 in the catheter tubing 12 is depicted, wherein the sensor 200 is disposed in the wall of the catheter tubing 12 within a milled cutout 198 defined longitudinally in the wall. An encapsulant 204, such as a thermally conductive epoxy, polyurethane, or RTV encapsulant, is included to cover the sensor 200. In one embodiment, the sensor 200 comprises a glucose sensor for sensing blood glucose levels and is not encapsulated, such that the glucose sensor is in direct contact with the blood. These and other possible sensor locations are contemplated.

[0073] Figure 18 Another configuration for including a sensor within the catheter tube 12 is depicted, wherein the sensor 200 is disposed on an interior surface within the lumen 14 of the catheter tube 12, near the distal end 12B of the lumen. An encapsulant 204 may be included to isolate and cover the sensor 200 as needed. In one embodiment, the encapsulant 200 protects the sensor 200 from exposure to liquid while allowing heat to be transferred therethrough. Figure 18 Additionally shown, a wire-based electrode 210 may be disposed in the wall of the catheter tube 12 proximate the distal end 12B of the catheter tube 12 so as to be exposed on its outer surface. The sensors 210 may be formed as concentrically disposed sensors that can be used to perform volumetric measurements to determine the size of the vessel in which the catheter tube is disposed, thereby helping the user determine if the catheter tube is incorrectly positioned in an undesired vessel. These and other possible sensor configurations are contemplated.

[0074] Figure 19Various details of a flush sensor 222 for detecting when a desired periodic flushing of the catheter 10 by a fluid occurs, also referred to herein as a flush state of the catheter tubing 12, are depicted. As shown, the flush sensor 222 is disposed within the cavity 220 of the luer connector of the catheter extension leg 18, although other locations for the sensor may be employed. The flush sensor 222, also referred to herein as a detection module, includes a rod 224 that is biased to an extended position by a spring 226 as shown. The flush sensor 222 is operably connected to a PCB (such as a Figure 10 A processor or other suitable component (eg, disposed within the Luer connector 20) of a PCB (eg, PCB 36) shown in FIG. 1 may be provided to control the operation of the flush sensor and process the data sensed thereby.

[0075] In operation, when a syringe or other component is inserted into the lumen 220 of the luer connector 20 to flush the catheter 10 with saline or other suitable fluid, the stem 224 of the flush sensor 222 is depressed, which causes a signal to be sent to the processor indicating that the flushing process is in progress. The time of the flush or other data related to the flushing process can be recorded, stored, or used by the processor, or such data can be wirelessly transmitted to a receiving location in a manner similar to that further described above. In one embodiment, the flush sensor 222 and the processor of the PCB 36 are referred to as a flush sensor assembly, but it should be understood that the assembly may include additional components. In another embodiment, an electrical sensor can be used as the flush sensor, wherein the electrical sensor includes a circuit that is disconnected each time a component is inserted into the connector 20. The disconnection of the circuit resets a timer circuit to measure the next period until the flush sensor is activated again.

[0076] In one embodiment, for example, it is desirable that the catheter 10 be flushed at least once every 12 hours. When the flush sensor 222 detects a flushing process as described above, a timer circuit in the processor is reset to begin counting time, thereby measuring the next period of time until the flush sensor 222 is depressed again to indicate a new flushing process.

[0077] Figure 20A light array 230 is shown, such as a collection of red, yellow, and green LED lights. These lights can be included on the surface of the luer connector 20 to indicate the flushing status of the catheter 10. In one embodiment, a green light indicates that less than 10 hours have passed since the last detected flushing event; a yellow light indicates that more than 10 hours but less than 12 hours have passed since the last flushing event; and a red light indicates that more than 12 hours have passed since the last flushing event. A processor controls the operation of the light array, and it should be understood that the lights can vary in number, size, location, purpose, elapsed time indication, etc. It should also be understood that other sensors can be used to detect flushing events, including sensors that detect the presence of liquid in the luer connector cavity 220.

[0078] In another embodiment, the light array 230 can be used as follows: a green light flashes after an acceptable flushing process has been performed; a red light flashes when an unacceptable or incomplete flushing process occurs; a yellow light flashes or illuminates to indicate that there may be an occlusion in the catheter tube 12; in another embodiment, the yellow light (or other light) can be illuminated to serve as a reminder to flush the catheter 10.

[0079] It should be appreciated that in another embodiment, the Luer connector 20 or other portion of the catheter 10 may include a button (or other user-activated component) that can be depressed when flushing the catheter, thereby resetting the timer circuit. In this case, a counting circuit may also be included to count the number of times the connector 20 or other component is accessed.

[0080] Figure 21 It is shown that the light array 230 can be positioned in other locations on the catheter 10, including in this embodiment on the hub 16. These and other possible locations are thus contemplated, such as the catheter tube or extension legs, or for example Figure 12 In other embodiments, a light array may be used to alert the user to other sensed conditions, including elevated body temperature / fever, sepsis (described below), catheter occlusion, low blood oxygen levels, etc. Additionally, in addition to lights, other indicia may be used to alert the user to sensor data, including sounds, vibrations, etc., either on the catheter itself or at a remote receiving location to which the data is wirelessly transmitted.

[0081] Note that the flush sensor 222 may also be included in other areas, including a needleless connector configured to operably attach to, for example, a Luer connector.

[0082] In one embodiment, a pressure sensor 32 (used alone or in combination with the above-mentioned flushing sensor 222) can be used to detect and / or characterize the flushing process. For example, in one embodiment, the flushing sensor 222 can be used to detect the flushing process, while the pressure sensor 32 can sense the amount of pressure during the flushing process, thereby detecting possible occlusion. In fact, in one embodiment, the pressure sensor 32 can be used to determine the flushing frequency, flushing technique, flushing time, number of catheter accesses, time elapsed since the last catheter access, etc. of the catheter 10 by using a timer circuit included on, for example, the PCB 36 to measure the pressure within the catheter lumen 14 as a function of time. Such sensor data can be stored by a memory location located on, for example, the PCB 36, or transmitted to another local or remote receiving location, as previously described. Processing to determine such monitoring can be performed by a processor included on the PCB 36, or performed remotely.

[0083] In one embodiment, sensor data from catheter sensors, such as pressure sensor 32 and core body temperature sensor, can be used to detect patient conditions, such as sepsis. Specifically, respiratory rate, heart rate, and body temperature can be sensed via pressure sensor 32 and core body temperature sensor 100 included with catheter 10, such as using Figure 10 These three parameters include three of the four parameters commonly used to determine the onset of sepsis. Therefore, in one embodiment, monitoring of these parameters via the catheter 10 described herein can be used to prevent, detect, and ameliorate complications from sepsis.

[0084] Figure 22 A sensor-based catheter assembly according to another embodiment is depicted. Specifically, a catheter 10 is shown having a catheter body 12 disposed in the patient's vascular system and two Luer connectors 20 operably connected to a supply line 240, both of which are configured to provide fluid to or remove fluid from the lumen of the catheter. A pump unit 250 is included to allow fluid to move through the supply line 240. If needed or desired, a saline fluid drop assembly 252 is also included to provide fluid to the pump unit to move through the supply line. A syringe, such as syringe 182, is included to provide an additional fluid inlet in a respective one of the supply lines 240.

[0085] Figure 23 Depicts Figure 22 Further details of the pump unit 250 include a fluid inlet 256A and a fluid outlet 256B configured to operatively connect to a corresponding supply line 240 ( Figure 22) to bring blood or other fluid from 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 in the pump unit 250 to move the fluid. In addition, various input ports 260 are included in the pump unit 250 in fluid communication with the liquid inlet 256A to allow for additional fluid input, including heparin, saline, arterial input, etc.

[0086] One or more sensors 200 are also included and arranged in the pump unit 250 to measure one or more physiological aspects of the patient's blood. Examples of such sensors include glucose meters, oxygen sensors, lactate sensors, cardiac output sensors, etc. The location of the sensors 200 may vary from that shown here. The placement of the sensors 200 in the pump unit 250 rather than on the catheter 10 itself enables the use of relatively larger sensors without unduly increasing the size of the catheter.

[0087] The embodiments of the present invention may be embodied in other specific forms without departing from the essence of the present disclosure. The embodiments described are to be considered in all respects as illustrative only and not restrictive. The scope of these embodiments is therefore indicated by the appended claims rather than the foregoing description. All variations coming within the meaning and range of equivalence of the claims are intended to be encompassed by the claims.

Claims

1. A catheter assembly for insertion into a patient's body, the catheter comprising: an elongated catheter tube defining at least one lumen extending between a proximal end and a distal end; a pressure indicator disposed in fluid communication 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 in the fluid passageway, at least the second position of the pressure indicator being visually discernible by a user; The pressure indicator is included in a pressure detection module, and the pressure detection module includes the fluid channel. 2 . The catheter assembly of claim 1 , wherein the pressure detection module is removably attached to the catheter assembly. The catheter assembly according to claim 1 , wherein the pressure detection module is integrally formed with the catheter.

4. The catheter assembly according to claim 2, wherein the pressure detection module is configured to be inserted between the proximal end of the catheter assembly and a fluid injection device, and the fluid injection device is configured to be operably connected to the fluid channel of the pressure detection module.

5. The catheter assembly of claim 4, wherein the fluid injection device comprises a syringe.

6. The catheter assembly of claim 2, wherein the pressure detection module is operably attached to a luer connector of the catheter.

7. The catheter assembly of claim 1, wherein moving from the first position to the second position comprises extending an indicator feature of the pressure indicator outwardly.

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