Occlusion detection devices, systems, and methods

Abstract

To provide a monitoring device to monitor a status of a catheter, which may indwell in a vasculature of a patient.SOLUTION: A monitoring device may include a housing, which may include a distal end, a proximal end, and a fluid pathway extending through the proximal end and distal end. The distal end may include a connector configured to couple to a catheter assembly. The monitoring device may include one or more sensors disposed within the fluid pathway. The sensors may facilitate identification of an occlusion within the catheter assembly.SELECTED DRAWING: Figure 3D

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to monitoring devices for monitoring the condition of catheters that may be placed in a patient's vascular system. [Background technology]

[0002] Intravenous therapy, a common medical procedure, can be facilitated by vascular access devices.

[0003] Hospitalized patients, home health care providers, and other patients often receive fluids, medications, and blood products via vascular access devices. Blood draws are another common medical procedure that can be facilitated by vascular access devices.

[0004] Vascular access devices may be inserted into a patient's peripheral and / or central vascular system. Vascular access devices may be left in place for short-term (days), medium-term (weeks), or long-term (months to years). Vascular access devices may be used for continuous or intermittent infusion therapy. Common types of vascular access devices are catheters, such as peripheral intravenous catheters (PIVCs) or peripherally inserted central catheters (PICCs).

[0005] When catheters remain in a patient's vasculature for extended periods of time, they can become more susceptible to obstruction or occlusion due to debris (e.g., fibrin or platelet clots). Obstruction can lead to catheter infection, pulmonary embolism, post-thrombotic syndrome, and other adverse health effects. Also, when obstructions occur within the catheter, the catheter can be removed or replaced, which can result in additional needle sticks, pain to the patient, and higher material costs. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent No. 5,533,412 Summary of the Invention [Problem to be solved by the invention]

[0007] Currently, clinicians are left to their own judgment to assess whether a catheter is occluded. Clinicians may determine whether a catheter is partially or completely occluded based on difficulty in returning blood or syringe pressure. Clinicians may not be adequately trained to determine whether a catheter is approaching complete occlusion. In response to determining that the catheter is partially or completely occluded, the clinician may intervene to relieve the occlusion.

[0008] Current occlusion removal or preventative measures include manually flushing the catheter. Thrombolytic agents can also be used to disrupt occlusions within the catheter. However, thrombolytic agents are often expensive, and their introduction can interrupt infusion therapy through the catheter.

[0009] The subject matter claimed herein is not limited to embodiments that solve all disadvantages or that operate only in environments such as those described above. Rather, this background is provided merely to illustrate technology areas in which some implementations described herein may be practiced. [Means for solving the problem]

[0010] summary The present disclosure generally relates to a monitoring device for monitoring the condition of a catheter that may be placed in a patient's vascular system. In some embodiments, the catheter may include a PIVC, PICC, or midline catheter. In some embodiments, the monitoring device may include a housing having a distal end, a proximal end, and a fluid pathway extending through the proximal end of the housing and the distal end of the housing.

[0011] In some embodiments, the distal end of the housing may include a connector configured to couple to a catheter assembly, which may include a catheter. In some embodiments, the distal end of the housing may include another connector. In some embodiments, the distal end of the housing and / or the proximal end of the housing may include a Luer connector.

[0012] In some embodiments, the monitoring device may include one or more sensors disposed in the fluid pathway. In some embodiments, the monitoring device may include a communication unit configured to wirelessly transmit an output signal to a receiving location. In some embodiments, the output signal may be based on data sensed by the sensor. In some embodiments, the housing may include one or more of a printed circuit board, a power source, and electrical contacts. In some embodiments, the communication unit and / or the processor may be disposed on the printed circuit board.

[0013] In some embodiments, the monitoring device may include another housing that may be removably coupled to the housing. In some embodiments, the another housing may include one or more of a printed circuit board, a power source, and another electrical contact. In some embodiments, the another electrical contact of the another housing may be operably connected to the electrical contact of the housing, which may facilitate communication between a sensor disposed within the housing and a printed circuit board within the another housing.

[0014] In some embodiments, at least one of the sensors disposed in the fluid pathway may include a pressure sensor that may be configured to detect fluid pressure of the fluid in the fluid pathway. In some embodiments, at least one of the sensors may include a flow sensor that may be configured to detect fluid flow rate and / or fluid throughput in the fluid pathway. In some embodiments, the monitoring device may include another pressure sensor that may be disposed proximal to the pressure sensor.

[0015] In some embodiments, the printed circuit board may include a processor. In some embodiments, the presence of an occlusion in the catheter assembly may be determined based on data sensed by the sensor. In some embodiments, the occlusion may be partial, partially blocking fluid flow through the catheter assembly, or complete, completely or substantially completely blocking fluid flow through the catheter assembly. In some embodiments, in response to determining the presence of an occlusion based on data sensed by the sensor and / or other sensors, the communications module may wirelessly transmit an output signal to a receiving location.

[0016] In some embodiments, in response to receipt of the output signal by the receiving location, an alert may be provided at the receiving location. In some embodiments, the alert may include a sound, a tactile vibration, or a visual cue such as, for example, a change in a light condition. In some embodiments, an indicator at the receiving location may be configured to provide the alert. Additionally or alternatively, in some embodiments, an indicator on the housing and / or another housing may be configured to provide the alert in response to determining the presence of an occlusion.

[0017] In some embodiments, the monitoring device may transmit the output signal over a network to a receiving location, which may include a patient's electronic medical record, a storage device, a smartphone or other mobile device, a computer server, a barcode scanner, a laptop computer, a nurse's station, a printer, or another suitable receiving location.

[0018] In some embodiments, a method for determining the presence of an occlusion in a catheter assembly can include coupling a monitoring device to an indwelling catheter assembly. In some embodiments, the method can include determining the presence of an occlusion in the catheter assembly based on data sensed by the sensor. In some embodiments, the method can include transmitting an output signal from the communications module to a receiving location in response to determining the presence of an occlusion in the catheter assembly.

[0019] In some embodiments, determining the presence of an occlusion in the catheter assembly based on data sensed by the sensor may include determining that the occlusion is partial in response to the sensor detecting an average maximum pressure in the fluid path between 14 psi and 42.5 psi. In some embodiments, the method may include providing a warning in response to determining that the occlusion is partial. In some embodiments, determining the presence of an occlusion in the catheter assembly based on data sensed by the sensor may include determining that the occlusion is complete in response to the sensor detecting an average maximum pressure of at least 42.5 psi. In some embodiments, the method may include providing a warning in response to determining that the occlusion is complete.

[0020] In some embodiments, determining the presence of an occlusion in the catheter assembly based on data sensed by the sensor may include determining that a pressure, such as an average maximum pressure, in the catheter assembly is greater than a threshold. In some embodiments, the sensor may include a first pressure sensor and a second pressure sensor that may be positioned proximal to the first pressure sensor in the fluid path. In some embodiments, the method may include determining a direction of fluid flow in the catheter assembly based on data sensed by the first pressure sensor and the second pressure sensor.

[0021] In some embodiments, the sensors may include a first flow sensor and a second flow sensor that may be positioned proximal to the first flow sensor in the fluid pathway. In some embodiments, the method may include determining a direction of fluid flow in the catheter assembly based on data sensed by the first flow sensor and the second flow sensor.

[0022] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and not restrictive. It is to be understood that the various embodiments are not limited to the arrangements and instrumentality shown in the drawings. Also, it is to be understood that the embodiments may be combined or other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the present disclosure, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense.

[0023] Exemplary embodiments of the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Brief explanation of the drawings]

[0024] [Figure 1A] FIG. 1 is a top perspective view of an exemplary monitoring device coupled to an exemplary catheter assembly, according to some embodiments. [Figure 1B] 1B is a top perspective view of the monitoring device of FIG. 1A, according to some embodiments. [Figure 2A] 1B is a cutaway view of the monitoring device of FIG. 1A according to some embodiments. [Figure 2B] 1B is another cutaway view of the monitoring device of FIG. 1A with the example circuit board, example battery, and example sensor removed, according to some embodiments. [Figure 2C] 2C is a cross-sectional view of the monitoring device of FIG. 1A taken along line 2C-2C of FIG. 2A, according to some embodiments. [Figure 2D]1B is another cutaway view of the monitoring device of FIG. 1A according to some embodiments. [Figure 2E] 1B is another cutaway view of the monitoring device of FIG. 1A according to some embodiments. [Figure 3A] FIG. 1 is an exploded view of another exemplary monitoring device, according to some embodiments. [Figure 3B] 3B is a top perspective view of the monitoring device of FIG. 3A, according to some embodiments. [Figure 3C] FIG. 3B is a bottom view of the first housing of the monitoring device of FIG. 3A, according to some embodiments. [Figure 3D] FIG. 3B is a side view of the monitoring device of FIG. 3A, according to some embodiments. [Figure 4] 1 is a top perspective view of an exemplary receiving position, according to some embodiments. FIG. [Figure 5] FIG. 1 is a block diagram of an exemplary monitoring system, according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0025] 1A, an exemplary catheter system 10 is shown, according to some embodiments. In some embodiments, the catheter system 10 may include a monitoring device 12 and a catheter assembly 16 that may be coupled to the monitoring device 12.

[0026] In some embodiments, the catheter assembly 16 may include a catheter adapter 18 and a catheter 20 extending distally from the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a side port 22 in fluid communication with a lumen of the catheter adapter 18. In some embodiments, the catheter adapter 18 may include a proximal end 23, a distal end 24, and a lumen extending therebetween. In some embodiments, the catheter 20 may include a PIVC, PICC, or midline catheter.

[0027] In some embodiments, the catheter assembly 16 may be removably coupled to a needle assembly, which may include a needle hub 26 and an introducer needle 28. In some embodiments, the introducer needle 28 may include a sharp distal tip 30. In some embodiments, the proximal end of the introducer needle 28 may be secured within the needle hub 26. In some embodiments, the introducer needle 28 may extend through the catheter 20 when the catheter assembly 16 is in an insertion position ready for insertion into the patient's vasculature, as shown, for example, in FIG. 1A . In some embodiments, in response to the introducer needle 28 being inserted into the patient's vasculature, blood flashback may flow through the sharp distal tip 30 of the introducer needle 28 and may be visible to the clinician between the introducer needle 28 and the catheter 20 and / or elsewhere within the catheter assembly 16.

[0028] In some embodiments, in response to confirmation via flashback that the catheter 20 is positioned within the patient's vasculature, the needle assembly may be detached from the catheter assembly 16. In some embodiments, for example, as shown in FIG. 1A, when the needle assembly is coupled to the catheter assembly 16, the introducer needle 28 of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter 18.

[0029] In some embodiments, the catheter assembly 16 may include an extension tube 34. In some embodiments, the distal end of the extension tube 34 may be integrated with the catheter adapter 18, for example, as shown in FIG. 1A. For example, the extension tube 34 may be integrated with the side port 22 of the catheter adapter 18. In some embodiments, the extension tube 34 may be removably coupled to the catheter adapter 18.

[0030] In some embodiments, an adapter 38 may be coupled to the proximal end of the extension tube 34. In some embodiments, the adapter 38 may include a Y-adapter or another suitable connector. In some embodiments, a needleless connector 40 may be coupled to the adapter 38. In some embodiments, the adapter 38 and / or the needleless connector 40 may be used to couple the catheter 20 to the monitoring device 12. In some embodiments, a medical device for fluid administration or blood withdrawal may be coupled to the proximal end of the monitoring device 12. The medical device may include an infusion bag, a syringe, or any other suitable medical device.

[0031] 1B, in some embodiments, monitoring device 12 may include a housing 42, which may include a distal end 44, a proximal end 46, and a fluid pathway 48 extending through proximal end 46 and distal end 44. In some embodiments, distal end 44 may include a connector configured to couple to catheter assembly 16. In some embodiments, proximal end 46 may include another connector. In some embodiments, the connector and / or the other connector may include a male or female Luer connector. In some embodiments, the Luer connector may include a Luer slip or Luer lock structure.

[0032] 2A-2E, in some embodiments, monitoring device 12 may include one or more sensors in fluid path 48. In some embodiments, fluid path 48 may be in fluid communication with a fluid path extending through catheter assembly 16. Thus, by detecting a condition in fluid path 48, the sensor may detect a condition in the fluid path extending through catheter assembly 16.

[0033] 2A-2C, in some embodiments, the sensors may include a flow sensor 50 and / or a pressure sensor 52. In some embodiments, the flow sensor 50 may be positioned distal to the pressure sensor 52. In some embodiments, the flow sensor 50 may be positioned proximal to the pressure sensor 52. For example, the positions of the flow sensor 50 and the pressure sensor 52 may be reversed from those shown in FIG. 2A. In some embodiments, the sensors may be positioned in various locations relative to the fluid path 48.

[0034] In some embodiments, flow sensor 50 may be configured to detect a fluid flow velocity and / or a fluid flow rate within fluid path 48. In some embodiments, pressure sensor 52 may be configured to detect a fluid pressure of the fluid within fluid path 48. In some embodiments, fluid path 48 may be enclosed within housing 42 such that fluid cannot leak from fluid path 48 as it flows between distal end 44 and proximal end 46. In some embodiments, fluid path 48 may extend through tunnel 54, which may include one or more holes 56 through which sensors may extend to surround fluid path 48.

[0035] In some embodiments, flow sensor 50 may include any suitable flow sensor capable of detecting fluid flow through fluid path 48. A variety of suitable fluid flow sensors are well known and may be used. Examples of suitable fluid flow sensors may include, but are not limited to, optical sensors, piezoelectric sensors, acoustic sensors, reed switch-based sensors, magnetic sensors, ultrasonic sensors, orifice-type flow meters, Venturi flow meters, and the like.

[0036] In some embodiments, the flow sensor 50 may include a thermal flow meter. In some embodiments, the thermal flow meter may include a heater, which may heat the fluid traveling through the fluid path 48. In some embodiments, the thermal flow meter may be configured to measure fluid temperature at upstream and downstream points in the fluid path 48. In some embodiments, the fluid flow rate may be determined based on the temperature difference between the upstream and downstream points. In some embodiments, the heater may be controlled to maintain a constant temperature at all times, and the fluid flow rate may be determined based on the amount of power required to maintain the constant temperature. An example of a flow sensor may be described in U.S. Patent Application Publication No. 2005 / 0129954, entitled "Pulsed Thermal Flow Sensor System," filed June 7, 1995, which is incorporated herein by reference in its entirety.

[0037] In some embodiments, pressure sensor 52 may include any suitable flow sensor capable of detecting fluid pressure within fluid path 48. In some embodiments, pressure sensor 52 may include a pressure-sensitive device, which may be capacitive, resistive, optical, or ultrasonic. In some embodiments, a first surface of pressure sensor 52 may be exposed to the fluid within fluid path 48, and a second surface (i.e., reference surface) of pressure sensor 52 may be exposed to a liquid or gas at a reference pressure. In some embodiments, a measured pressure difference between the first and second surfaces of pressure sensor 52 may provide an indication of the fluid pressure to which the first surface is exposed.

[0038] In some embodiments, monitoring device 12 may include a communications unit 58 configured to wirelessly transmit an output signal to a receiving location. In some embodiments, the output signal may be based on data sensed by a sensor. In some embodiments, a printed circuit board (“PCB”) 60 and / or a power source 62 may be disposed within housing 42. In some embodiments, power source 62 may include a battery, which may be rechargeable and / or replaceable. In some embodiments, the location of PCB 60 and / or power source 62 within housing 42 may vary.

[0039] In some embodiments, power source 62 may be electrically coupled to the sensor and configured to provide power to the sensor. In some embodiments, power source 62 may be located remotely from PCB 60 and even catheter assembly 16. In some embodiments, a non-volatile memory storage location, such as, for example, flash memory, may be included on PCB 60, allowing data sensed by the sensor to be stored therein, either temporarily or permanently. In some embodiments, the storage location may be accessed by a user and / or transmitted to a receiving location.

[0040] In some embodiments, the communications unit 58 and / or the processor may be disposed on the PCB 60, which may be electrically coupled to the sensors. In some embodiments, the presence of an occlusion in the catheter assembly 16 may be determined based on data sensed by the sensors. In some embodiments, the occlusion may be partial, which partially blocks fluid flow through the catheter assembly, or complete, which completely or substantially completely blocks fluid flow through the catheter assembly. In some embodiments, in response to determining the presence of an occlusion based on data sensed by the sensors, the communications unit 58 may wirelessly transmit an output signal to a receiving location.

[0041] In some embodiments, in response to receipt of the output signal by the receiving location, an alert may be provided at the receiving location. In some embodiments, the alert may include a sound, a tactile vibration, or a visual cue, such as, for example, a change in a light condition. In some embodiments, an indicator at the receiving location may be configured to provide the alert.

[0042] Additionally or alternatively, in some embodiments, an indicator on the housing 42 may be configured to provide a warning in response to determining the presence of an occlusion. In some embodiments, the indicator may include one or more lights, which may be arranged in various configurations. Referring back to FIG. 1B , in some embodiments, the warning may include a visual cue, which may include a change in the state of one or more lights 64. For example, one or more lights 64 may illuminate or change color in response to determining the presence of an occlusion, such as a partial occlusion or a complete occlusion.

[0043] 2A-2E, in some embodiments, the presence of air bubbles in fluid path 48 may be determined in response to pressure sensor 52 detecting a drop in fluid pressure in fluid path 48. In some embodiments, the magnitude of the drop may be greater than a predetermined threshold. In some embodiments, an indicator on housing 42 and / or at a receiving location may be configured to provide a warning in response to determining the presence of an air bubble.

[0044] In some embodiments, the monitoring device 12 may transmit the output signal over a network to a receiving location, which may include a patient's electronic medical record, a storage device, a smart phone or another mobile device, a computer server, a barcode scanner, a laptop computer, a nurse's station, a printer, or other suitable receiving location.

[0045] 2D, for example, the sensors may include at least two pressure sensors, which may include or correspond to pressure sensor 52 of FIG. 2A. In some embodiments, the two pressure sensors may provide a more robust determination of an occlusion in the catheter system 10 and / or may facilitate determining the direction of fluid flow in the fluid path 48. In some embodiments, the direction of fluid flow may be determined in response to a first of the two pressure sensors detecting an increase in fluid pressure in the fluid path 48 before or after a second of the two pressure sensors.

[0046] In some embodiments, the presence of an air bubble in the fluid path 48 may be determined in response to one or more of the two pressure sensors detecting a decrease in fluid pressure in the fluid path 48. In some embodiments, the direction of travel of the air bubble may be determined in response to a first of the two pressure sensors detecting a decrease in fluid pressure in the fluid path 48 before or after a second of the two pressure sensors.

[0047] In some embodiments, for example, as shown in Figure 2E, the sensor may include at least two flow sensors, which may include or correspond to flow sensor 50 of Figure 2A. In some embodiments, the direction of fluid flow may be determined in response to a first of the two flow sensors detecting an increase in fluid pressure in fluid path 48 before or after a second of the two flow sensors.

[0048] 3A-3D , in some embodiments, another housing 66 may be removably coupled to housing 42. In some embodiments, another housing 66 may include one or more of PCB 60, power source 62, and one or more electrical contacts 68. In some embodiments, housing 42 may include one or more other electrical contacts 70, which may be operably coupled to the electrical contacts 68 of another housing 66, such that power source 62 may provide power to the sensors and / or data from the sensors may be transmitted to PCB 60.

[0049] In some embodiments, housing 42 and another housing 66 may be coupled together via any suitable coupling mechanism, including, for example, threads, a snap fit, an interference fit, friction, or adhesive. In some embodiments, housing 42 or another housing 66 may include a groove or cavity 71. In some embodiments, housing 42 or another housing 66 may include a protrusion 72 that may be configured to fit snugly within cavity 71.

[0050] In some embodiments, housing 42 may be discarded after use, and another housing 66 may be reusable. In some embodiments, another housing 66 may be cleaned and reused for the care of another patient. In some embodiments, another housing 66 may be detached from housing 42 and coupled to another housing similar to housing 42. In some embodiments, placement of PCB 60 and / or communication unit 58 within another housing 66 may provide space for sensors within housing 42 and / or may prevent replacement of PCB 60, a relatively expensive component, when housing 42 is replaced.

[0051] In some embodiments, the separate housing 66 may include an indicator configured to provide a warning in response to determining the presence of an occlusion. For example, the separate housing 66 may include lights 64, which may be arranged in various configurations. In some embodiments, the lights 64 and / or legends proximate the lights 64 may be arranged, for example, as shown in FIG. 1B . In some embodiments, the lights 64 may illuminate or change color in response to determining the presence of an occlusion, such as a partial occlusion or a complete occlusion. In some embodiments, the housing 42 and / or the separate housing 66 may include a display 74, which may be an indicator.

[0052] Referring now to FIG. 4 , an exemplary receiving location is shown, according to some embodiments. In some embodiments, the receiving location may include a clinician monitoring device 76. Examples of the clinician monitoring device 76 may include a computing device, a mobile phone, a smartphone, a tablet computer, a laptop computer, a desktop computer, a medical instrument, or a connected device (e.g., a smartwatch, smart glasses, or any other connected device). In some embodiments, the clinician monitoring device 76 may provide an alert in addition to, or as an alternative to, the monitoring device 12 providing an alert. In some embodiments, the clinician monitoring device 76 may include a pump that may be coupled to the proximal end 46 of the monitoring device 12 and configured to infuse the catheter system 10 in response to receiving the output signal.

[0053] In some embodiments, the clinician monitoring device 76 may include a display screen 78 that may provide an alert. In some embodiments, the alert may include phrases such as, for example, "partial occlusion" or "total occlusion." In some embodiments, the alert may include a visual cue on the display screen 78, such as a portion 80 of the display screen 78 that lights up or changes color. In some embodiments, the portion 80 of the display screen 78 may flash or change flashing rate to provide the alert. In some embodiments, an electronic health record may be presented on the display screen 78 of the clinician monitoring device 76.

[0054] 5 is a block diagram of a monitoring device 12 arranged in accordance with at least one embodiment described in this disclosure. In some embodiments, the monitoring device 12 may include a computing system 82, which may include, for example, the PCB 60 described with respect to FIG. 2A.

[0055] In some embodiments, computing system 82 may include processor 84, memory 86, data storage device 88, and communication unit 58. In some embodiments, processor 84, memory 86, data storage device 88, and communication unit 58 may be communicatively coupled by bus 90. Bus 90 may include, but is not limited to, a controller area network (CAN) bus, a memory bus, a storage interface bus, a bus / interface controller, an interface bus, etc., or any combination thereof. In some embodiments, processor 84 may include timer 98. In some embodiments, timer 98 may be a separate component coupled to processor 84.

[0056] In general, processor 84 may include any suitable special-purpose or general-purpose computer, computing entity, or processing device, including various computer hardware or software modules, configured to execute instructions stored on any applicable computer-readable storage medium. For example, processor 84 may include a microprocessor, microcontroller, digital signal processor (DSP), application-specific integrated circuit (ASIC), field-programmable gate array (FPGA), or any other digital or analog circuit configured to interpret and / or execute program instructions and / or process data. Although shown as a single processor in FIG. 5, processor 84 may include any number of processors configured, individually or collectively, to perform any number of operations described in this disclosure. Furthermore, one or more processors 84 may reside on one or more different electronic devices.

[0057] In some embodiments, processor 84 may interpret and / or execute program instructions and / or process data stored in memory 86, data storage device 88, or memory 86 and data storage device 88. In some embodiments, processor 84 may retrieve program instructions from data storage device 88 and write the program instructions to memory 86. In some embodiments, processor 84 may execute the program instructions after they are written to memory 86.

[0058] For example, in some embodiments, the occlusion module 92 may be included as program instructions in the data storage device 88. In some embodiments, the occlusion module 92 may be configured to manage flow conditions within a catheter system, such as, for example, the catheter system 10 described with respect to FIG. 1. The processor 84 may retrieve the program instructions for the occlusion module 92 from the data storage device 88 and write the program instructions for the occlusion module 92 to the memory 86. After the program instructions for the occlusion module 92 are written to the memory 86, the processor 84 may execute the program instructions such that the computer system 82 may perform the operations associated with the occlusion module 92 as directed by the instructions.

[0059] Memory 86 and data storage device 88 may include computer-readable storage media for holding or having computer-executable instructions or data structures stored thereon. Such computer-readable storage media may include any available media that can be accessed by a general-purpose or special-purpose computer, such as processor 84. By way of example, and not limitation, such computer-readable storage media may include tangible or non-transitory computer-readable storage media, including RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage, flash memory devices (e.g., solid-state storage), or any other storage medium that can be used to hold or store desired program code in the form of computer-executable instructions or data structures and that can be accessed by a general-purpose or special-purpose computer. Combinations of the above may also be included within the scope of computer-readable storage media. Computer-executable instructions may include, for example, instructions and data configured to cause processor 84 to perform a particular operation or group of operations.

[0060] In some embodiments, one or more clinician monitoring devices 87 may be connected to the computer system 82 via a network 94. In these and other embodiments, the network 94 may include a wired or wireless network and may have any suitable type, such as a star, token ring, or other type. Further, in some embodiments, the network 94 may include an Ethernet network, a local area network (LAN), a wide area network (WAN) (e.g., the Internet), and / or other interconnected data paths through which multiple devices may communicate. In some embodiments, the network 94 may include a peer-to-peer network. In some embodiments, the network 94 may also be coupled to or include a portion of a telecommunications network that may enable communication of data in a variety of different communication protocols. In some embodiments, the clinician monitoring device 87 may include or correspond to the clinician monitoring device 76 described with respect to FIG. 4.

[0061] In some embodiments, network 94 may include a BLUETOOTH® and / or cellular communication network for transmitting and receiving data, including Short Messaging Service (SMS), Multimedia Messaging Service (MMS), Hypertext Transfer Protocol (HTTP), direct data connection, Wireless Application Protocol (WAP), email, etc. Network 94 may enable communication via a standards-compliant protocol, such as Smart Energy Profile (SEP), Echonet Lite, OpenADR, or another suitable protocol (e.g., Wi-Fi, ZigBee, HomePlug Green, etc.).

[0062] In some embodiments, the communications unit 58 may be configured to transmit data to and receive data from the clinician monitoring device 87 via the network 94. In some embodiments, the communications unit 58 may also be configured to transmit and receive data from the display screen and / or the electronic health record 100. In some embodiments, the display screen may include or correspond to the display screen 78 described with respect to FIG. 4. In some embodiments, the occlusion module 92 may be configured to transmit and receive data via the communications unit 58.

[0063] In some embodiments, the communications unit 58 may include a port for direct physical connection to the network 94 and / or another communications channel. For example, the communications unit 58 may include a Universal Serial Bus (UBS) port, a Secure Digital (SD) port, a Category 5 Cable (CAT-5) port, or a similar port for wired communications with another device. In some embodiments, the communications unit 58 may include a wireless transceiver for exchanging data with the clinician monitoring device 87 or other communications channels using one or more wireless communications methods, including IEEE 802.11, IEEE 802.16, BLUETOOTH, or another suitable wireless communications method.

[0064] In some embodiments, communication unit 58 may include a cellular communication transceiver for transmitting and receiving data over a cellular communication network, including SMS, MMS, HTTP, direct data connection, WAP, email, or another suitable type of electronic communication. Communication unit 58 may also provide other conventional connections to network 94 for distribution of files or media objects using standard network protocols, including Transmission Control Protocol / Internet Protocol (TCP / IP), HTTP, HTTP Secure (HTTPS), and Simple Mail Transfer Protocol (SMTP).

[0065] In some embodiments, examples of how the occlusion module 92 may manage flow conditions within the catheter assembly are now provided. In some embodiments, the occlusion module 92 may determine the presence of an occlusion within the catheter assembly based on data sensed by a sensor, such as, for example, a sensor of the monitoring device 12 described with respect to one or more of FIGS. 1A-3D. In some embodiments, the occlusion module 92 may be configured to transmit an output signal from the communication module to a receiving location in response to determining the presence of an occlusion within the catheter assembly.

[0066] In some embodiments, the occlusion module 92 may be configured to determine that the occlusion is partial in response to the sensor detecting an average maximum pressure of between 14 psi and 42.5 psi in the fluid path proximate the sensor. In some embodiments, the occlusion module 92 may be configured to generate an alarm and / or output signal in response to determining that the occlusion is partial. In some embodiments, the occlusion module 92 may be configured to determine that the occlusion is complete in response to the sensor detecting an average maximum pressure of at least 42.5 psi. In some embodiments, the occlusion module 92 may be configured to generate an alarm and / or output signal in response to determining that the occlusion is complete.

[0067] In some embodiments, the occlusion module 92 can be configured to determine that a pressure, such as an average maximum pressure, in the catheter assembly is greater than a threshold value. In some embodiments, the occlusion module 92 can be configured to determine a direction of fluid flow in the catheter assembly based on data sensed by the sensor.

[0068] In some embodiments, the external server may include one or more components of the computer system 82. In some embodiments, the external server may be connected to the monitoring device 12 and / or the clinician monitoring device 87 via the network 94 or another network. Modifications, additions, or omissions may be made to the computer system 82 without departing from the scope of the present disclosure.

[0069] All examples and conditional language set forth herein are intended as educational objects to aid the reader in understanding the invention and concepts provided by the inventors to further the art, and should be construed as not being limited to such specifically set forth examples and conditions. Although embodiments of the invention may be described in detail, it should be understood that various changes, substitutions, and alterations can be made thereto without departing from the spirit and scope of the invention.

Claims

1. 1. A monitoring device for monitoring a condition of a catheter, the monitoring device comprising: A first housing, the first housing comprising: a distal end; and a proximal end; a fluid pathway extending through the proximal end and the distal end, the distal end including a connector configured to couple to a catheter assembly; and a sensor disposed within the fluid path; the first housing including an electrical contact; a second housing, the second housing comprising: a printed circuit board; a communication unit configured to receive an output signal from the sensor in the first housing and to wirelessly transmit the output signal to a receiving location, the output signal being based on data sensed by the sensor in the first housing, the communication unit being disposed on the printed circuit board; the second housing including an electrical contact; the electrical contacts of the first housing are operably coupled to the electrical contacts of the second housing; The second housing is removably coupled to the first housing.

2. 2. The monitoring device of claim 1, wherein the printed circuit board of the second housing includes a processor configured to determine the presence of an occlusion in the catheter assembly based on data sensed by the sensor, and wherein the communication unit of the first housing transmits the output signal to the receiving location in response to the processor determining the presence of the occlusion based on the data sensed by the sensor.

3. 3. The monitoring device of claim 2, wherein the first housing includes an indicator configured to provide a warning in response to the processor determining that an occlusion exists.

4. 4. The monitoring device according to claim 3, wherein the blockage is a partial blockage or a complete blockage.

5. 2. The monitoring device of claim 1, wherein the sensor includes a pressure sensor configured to detect a fluid pressure of a fluid in the fluid path.

6. 6. The monitoring device of claim 5, wherein the sensor is a flow sensor configured to detect a fluid flow rate of fluid in the fluid path.

7. 6. The monitoring device of claim 5, wherein another pressure sensor is located proximal to the pressure sensor.

8. 10. The monitoring device of claim 1, wherein the proximal end of the housing includes another connector, the other connector including a luer connector.

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