Catheter assembly clamp having acoustic sensor

Abstract

To provide a method for monitoring a flow of fluid flowing through a catheter assembly.SOLUTION: A method is for monitoring a flow of fluid passing a catheter assembly and includes: a step which provides a clamp disposed to fasten an extension tube of the catheter assembly, the clamp provided with an acoustic sensor arranged to detect fluid flowing through the extension tube and the clamp and acoustic sensor disposed outside the extension tube; and a step which detects a flow of fluid flowing through the extension tube via the acoustic sensor.SELECTED DRAWING: Figure 1A

Description

[Technical field]

[0001] Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline solution, various medicines, and parenteral nutrients into a patient. Catheters may also be used to withdraw blood from a patient. [Background technology]

[0002] Common types of catheters are over-the-needle peripheral intravenous catheters ("PIVC"), peripherally inserted central catheters ("PICC"), or midline catheters. As the name implies, over-the-needle catheters may be mounted over an introducer needle with a sharp distal tip. The sharp distal tip may be used to pierce the skin and the patient's blood vessel. Insertion of the catheter into the blood vessel may follow piercing of the vessel with the needle. The needle and catheter are typically inserted at a shallow angle through the skin into the patient's vasculature, with the bevel of the needle facing away from the patient's skin. Once placement of the introducer needle in the vasculature has been confirmed, the physician may temporarily shut off flow in the vasculature and withdraw the introducer needle, leaving the catheter in place within the vessel for subsequent blood withdrawal and / or fluid injection.

[0003] For example, catheters may become unstable or compromise due to catheter occlusion over time. In response to a catheter becoming occluded, the catheter may need to be removed and replaced with a new catheter. Catheter occlusion may be thrombotic, resulting from the formation of a clot in or around the distal end of the catheter. Catheter occlusion may be non-thrombotic, resulting from deposits, mechanical obstruction, and other factors. Additionally, catheter occlusion may result in catheter infection, acute pulmonary embolism, post-thrombotic syndrome, and other negative health outcomes. Physicians may periodically flush catheters to prevent occlusion and prolong the duration of catheter placement.

[0004] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. Summary of the Invention

[0005] The present disclosure relates generally to vascular access systems and associated devices and methods. In some embodiments, a method of managing cleaning of a catheter assembly may include providing a clamp for an extension tube of the catheter assembly. In some embodiments, the clamp may include an acoustic sensor that may be positioned to detect whether the clamp is open or fluid is flowing through the extension tube of the catheter assembly. In some embodiments, the acoustic sensor may be positioned to detect whether the clamp is closed or fluid is not flowing through the extension tube of the catheter assembly.

[0006] In some embodiments, the method may include initiating a timer in response to the acoustic sensor detecting that the clamp is closed. In some embodiments, the method may include providing an alert in response to the timer reaching a predetermined amount of time. In some embodiments, the alert may indicate to a physician that the catheter assembly should be opened and cleaned to prevent blockage of the catheter assembly.

[0007] In some embodiments, providing the alert may include sending an alert signal over a network to a monitoring device so that a physician can monitor the device. In some embodiments, the alert signal may instruct the monitoring device to provide an alert. In some embodiments, the alert may comprise a sound, a tactile vibration, or a visual cue. In some embodiments, the visual cue may comprise a change in state of a light. In some embodiments, in response to the acoustic sensor detecting that the clamp is closed, an indication may be provided in the patient's electronic health record.

[0008] In some embodiments, an acoustic sensor may be positioned to detect that the clamp is open. In some embodiments, in response to the acoustic sensor detecting the clamp being open for another predetermined amount of time, the timer may be stopped and / or reset. In some embodiments, in response to the acoustic sensor detecting the clamp being open for another predetermined amount of time, a different alert signal may be sent over the network to the monitoring device to stop the alert or provide a different alert. In some embodiments, in response to the acoustic sensor detecting the clamp being open for another predetermined amount of time, a different indication may be provided on the patient's electronic health record.

[0009] In some embodiments, another acoustic sensor may be provided. In some embodiments, the acoustic sensor and the other acoustic sensor may provide a robust determination of whether fluid is flowing through the extension tube and the clamp is open or closed. In some embodiments, the acoustic sensor may be located distal to the other acoustic sensor. In some embodiments, the direction of fluid flow in the extension tube may be determined in response to the acoustic sensor detecting fluid flow through the extension tube before or after the other acoustic sensor detecting fluid flow through the extension tube. In some embodiments, a timer may be stopped and / or reset in response to the other acoustic sensor detecting that the clamp is open and fluid is flowing through the extension tube of the catheter assembly.

[0010] The object and advantages of the embodiments will be realized and achieved at least by the elements, features, and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention, as claimed. [Brief description of the drawings]

[0011] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings.

[0012] [Figure 1A] FIG. 1 is a top perspective view of an exemplary catheter system according to some embodiments. [Figure 1B] FIG. 1 is a top perspective view of an exemplary clamp showing the clamp in an open position according to some embodiments. [Figure 1C] FIG. 1C is a top perspective view of the clamp of FIG. 1B showing the clamp in a closed position according to some embodiments. [Figure 2A] FIG. 1 is a top perspective view of an exemplary physician monitoring device according to some embodiments. [Figure 2B]1 is an exemplary electronic health record that may be shown on a display screen of an exemplary physician monitoring device according to some embodiments. [Diagram 3] 1 is a block diagram of an example cleaning management system according to some embodiments. [Figure 4A] 1B is a top perspective view of another exemplary clamp that may be used in the catheter system of FIG. 1A, showing the clamp in an open position. [Figure 4B] FIG. 4B is a top perspective view of the clamp of FIG. 4A, showing the clamp in a closed position. [Figure 5A] 4 is a graph of an exemplary waveform generated by an acoustic sensor. [Figure 5B] 1 is a graph of exemplary waveforms generated by two acoustic sensors. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] 1A, an exemplary catheter system 14 is shown according to some embodiments. In some embodiments, the catheter system 14 may include a catheter assembly 16. In some implementations, the catheter assembly 16 may include a catheter adapter 18 and a catheter 20 extending distally from the catheter adapter 18. In some implementations, the catheter adapter 18 may include a side port 22 in fluid communication with a lumen of the catheter adapter 18. In some implementations, the catheter adapter 18 may include a proximal end 23, a distal end 24, and a lumen extending therebetween. In some implementations, the catheter 20 may include a PIVC.

[0014] In some embodiments, the catheter assembly 16 may be movably 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 sharpened distal end. In some embodiments, the proximal end of the introducer needle 28 may be fixed within the needle hub 26.

[0015] 1A, when the catheter assembly 16 is in a pre-insertion position for insertion into a patient's blood vessel, an introducer needle 28 may extend through the catheter 20. In some embodiments, in response to the introducer needle 28 being inserted into a patient's blood vessel, a flashback of blood may flow through the sharpened distal end 30 of the introducer needle 28 and be visible to the physician between the introducer needle 28 and the catheter 20 and / or elsewhere in the catheter assembly 16.

[0016] In some embodiments, in response to confirmation via blood flashback that the catheter 20 is disposed within the patient's blood vessel, the needle assembly may be removed 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, an introducer needle 28 of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter 18.

[0017] In some embodiments, the catheter system 14 may include a catheter line 32, which may include an extension tube 34 and a clamp 36 through which the extension tube 34 may extend. In some embodiments, the distal end of the extension tube 34 may be integral with the catheter adapter 18, as shown, for example, in FIG. 1A. For example, the extension tube 34 may be integral with the side port 24 of the catheter adapter 18. In some embodiments, the extension tube 34 may be movably coupled to the catheter adapter 18. In some embodiments, the clamp 36 may selectively close the extension tube 34 to prevent blood or another fluid from flowing through the extension tube 34.

[0018] 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 comprise 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 connect the catheter 20 to a medical device for administering fluids or withdrawing blood. The medical device may comprise an infusion bag, a syringe, or any other suitable medical device.

[0019] In some embodiments, the catheter system 14 may comprise any suitable catheter assembly 16, and the clamp 36 may be coupled to any suitable extension tube. In some embodiments, the extension tube 34 may extend from the proximal end 23 of the catheter adapter 18. In some embodiments, the clamp 36 may be placed on an IV line, which may extend between an IV bag and the catheter assembly 16. In some embodiments, the catheter assembly 16 may comprise a PIVC, PICC, or midline catheter. In some embodiments, a peripherally inserted central catheter ("PICC") assembly may be coupled to one or more pigtail extension tubes.

[0020] In some embodiments, the extension set may be configured to be directly or indirectly coupled to the catheter assembly 16. In some embodiments, the extension set may comprise an IV line, extension tubing 34, or any other extension tubing in fluid communication with the catheter assembly 16. In some embodiments, the extension set may comprise a clamp 36.

[0021] 1B, in response to the clamp 36 being open, fluid may flow through the extension tube 34 and the catheter assembly 16. For example, fluid may be infused into the patient via a medical device coupled to the adapter 38, or blood may be drawn from the patient into a blood collection device coupled to the adapter 38. In some embodiments, the clamp 38 may include a first acoustic sensor 42a and / or a second acoustic sensor 42b (collectively referred to herein as "acoustic sensors 42"). In some embodiments, each of the acoustic sensors 42 may be positioned to detect that fluid flows through the extension tube 34 or that the clamp 36 is open. In some embodiments, each of the acoustic sensors 42 may be positioned to detect that fluid does not flow through the extension tube 34 or that the clamp 36 is closed. In some embodiments, the first acoustic sensor 42a and / or the second acoustic sensor 42b may include one or more microphones.

[0022] In some embodiments, the first acoustic sensor 42a and the second acoustic sensor 42b may provide a robust determination of whether fluid is flowing through the extension tube 34 and the clamp 36 is open or closed. In some embodiments, the first acoustic sensor 42a may be disposed at a distal end of the second acoustic sensor 42b. In some embodiments, the direction of fluid flow within the extension tube 34 may be determined in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before or after the other acoustic sensor 42b detects fluid flow through the extension tube 34. In some embodiments, the direction of fluid flow may be determined to be proximal in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before the second acoustic sensor 42b detects fluid flow through the extension tube 34. In some embodiments, the direction of fluid flow may be determined to be distal in response to the second acoustic sensor 42b detecting fluid flow through the extension tube 34 before the first acoustic sensor 42a.

[0023] In some embodiments, the acoustic sensor 42 may be electrically coupled to a circuit board 43 and a charger 44. In some embodiments, the locations of the circuit board 43 and the charger 44 may vary. In some embodiments, the circuit board 43 may include a transmitting unit.

[0024] 1C , in response to clamp 36 being closed, fluid may be prevented from flowing through extension tube 34. In some embodiments, in response to clamp 36 being closed, substantially all of the fluid may be prevented from flowing through extension tube 34. In some embodiments, clamp 36 may be a clamping clamp, which may clamp extension tube 34 in response to movement of clamp 36 to a closed position.

[0025] In some embodiments, clamp 36 may be any clamp coupled to an extension tube, such as extension tube 34. In some embodiments, an exemplary clamp 36 is described in U.S. Patent Application 15 / 286,248, filed October 5, 2016, entitled "CLAMPING CLAMP DEVICE," which is incorporated herein by reference. In some embodiments, extension tube 34 may extend through clamp 36. In some embodiments, clamp 36 may include arm 47, which may include a protrusion that contacts and clamps extension tube 34. In some embodiments, clamp 36 may include any suitable clamp, and acoustic sensor 42 may include any suitable acoustic sensor. In some embodiments, acoustic sensor 42 may be positioned in a variety of locations.

[0026] In some embodiments, the acoustic sensor 42 may be embedded in the clamp 36. In these and other embodiments, one or more acoustic sensors 42 may be in contact with the extension tube 34. In some embodiments, one or more acoustic sensors 42 may be spaced apart from the extension tube 34. In some embodiments, the first acoustic sensor 42a may be positioned distally relative to the second acoustic sensor 42b.

[0027] In some embodiments, the portion of the acoustic sensor 42 may vary. In some embodiments, the acoustic sensor 42 may be located on a clamping surface of the clamp 36 that contacts the extension tube 34 when the clamp 36 is in an open and / or closed position. In some embodiments, the clamping surface may be generally flat or curved. In some embodiments, the acoustic sensor 42 may be located on a non-clamping surface. In some embodiments, the acoustic sensor 42 may be located on opposite sides of the extension tube 34. In some embodiments, the acoustic sensor 42 may be located on the same side of the extension tube 34.

[0028] In some embodiments, the clamp 36 may provide an alert, which may comprise a sound, a tactile vibration, or a visual cue. In some embodiments, the visual cue may include a change in the state of a light. FIGS. 1B-1C show an example light 48 according to some embodiments. In some embodiments, in response to the clamp being closed for a predetermined amount of time, the state of the light 48 may change. For example, in response to the clamp being closed for a predetermined amount of time, the light 48 may be illuminated or change color. As another example, in response to the clamp 36 being closed for a predetermined amount of time, the light 38 may flash or change a flashing rate.

[0029] In some embodiments, the predetermined amount of time may correspond to a time prior to a medically recommended time to flush the catheter assembly 16. In these embodiments, the alert may include a warning that may indicate to a physician that the medically recommended time to flush the catheter assembly 16 is approaching. In some embodiments, the medically recommended time to flush the catheter assembly 16 may be between about 6 hours and about 8 hours since the last flush of the catheter assembly 16.

[0030] In some embodiments, the predetermined amount of time may correspond to a medically recommended time to flush the catheter assembly 16. In some embodiments, a first alert may be provided by the clamp 36 in response to approaching a medically recommended time (such as 30 minutes, 10 minutes, or 5 minutes) to flush the catheter assembly 16, and a second alert may be provided by the clamp 36 in response to reaching the medically recommended time to flush the catheter assembly 16. In some embodiments, the first alert may comprise a yellow or orange light, and the second alert may comprise a red light.

[0031] In some embodiments, the light 48 may be positioned at various locations on the clamp 36 that may be visible to the physician. In some embodiments, the clamp 36 may include multiple lights 48. In some embodiments, the size of the light 48 may vary.

[0032] 2A, an exemplary physician monitoring device 46 is shown, according to some embodiments. Examples of physician monitoring device 46 may include a computing device, a mobile phone, a smart phone, a tablet computer, a laptop computer, a desktop computer, a medical device, or a coupling device (e.g., a smart phone, smart glasses, or any other coupling device). In some embodiments, in addition to or as an alternative to clamp 36, physician monitoring device 46 may provide an alert.

[0033] In some embodiments, the physician monitoring device 46 may include a display screen 50 that may provide an alert. In some embodiments, the alert may include a phrase such as, for example, "Flush Due." In some embodiments, the alert may include a visual cue on the display screen 50, such as a portion of the display screen 50 that lights up or changes color. In some embodiments, a portion of the display screen 50 may flash or change a flash rate to provide the alert. In some embodiments, the physician monitoring device 46 may include a light 48, such as described with respect to FIG. 1C.

[0034] 2B, an exemplary electronic health record 52 shown on a display screen 50 of a physician monitoring device 46 is shown according to some embodiments. In some embodiments, an indication may be provided on the display screen 50 in response to opening and / or closing the clamp 36. In some embodiments, an indication may be provided on the display screen 50 in response to opening the clamp 36 for a particular predetermined amount of time and / or closing the clamp 36 for a particular predetermined amount of time.

[0035] In some embodiments, the display may include one or more of the following: date and time 56, current state 58, and length of time 60. In some embodiments, length of time 60 may include the amount of time that clamp 36 has been closed. In some embodiments, current state 58 may include "open" and may be adjacent to date and time 56, indicating to the physician when clamp 36 is open. In some embodiments, current state 58 may include "closed" and may be adjacent to date and time 56, indicating to the physician when clamp 36 is closed.

[0036] 3 is a block diagram of an exemplary cleaning management system (FM system) 62 arranged in accordance with at least one embodiment described herein. In some embodiments, FM system 62 may include a clamp 63. In some embodiments, clamp 63 may include or correspond to clamp 63 described with respect to FIG. 1 or clamp 90 described with respect to FIG. 4. In some embodiments, clamp 63 may include a computing system 64.

[0037] In some embodiments, the computing system 64 may include a processor 66, a memory 68, a data store 70, and a communication unit 72. In some embodiments, the processor 66, the memory 68, the data store 70, and the communication unit 72 may be communicatively coupled by a bus 74. The bus 74 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, the processor 66 may include a timer 75. In some embodiments, the timer 75 may be a separate component linked to the processor 66.

[0038] Generally, the processor 66 may be any suitable special or general purpose computer, computer entity, or processor device comprising a variety of computer hardware and software modules and configured to execute instructions stored on an applicable computer-readable storage medium. For example, the processor 66 may comprise a microprocessor, a microcontroller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other digital or analog circuitry configured to decode and / or execute program instructions and / or process data. Although one processor is shown in FIG. 3, the processor 66 may comprise multiple processors configured to perform many operations, individually or collectively, as described in this disclosure. Furthermore, one or more of the processors 66 may reside on one or more different electronic devices.

[0039] In some embodiments, processor 66 may decode and / or execute program instructions and / or process data stored in memory 68, data store 70, or memory 68 and data store 70. In some embodiments, processor 66 may retrieve program instructions from data store 70 and load the program instructions into memory 68. In some embodiments, processor 66 may execute the program instructions after the program instructions are loaded into memory 68.

[0040] For example, in some embodiments, the cleaning module 76 may be included in the data store 70 as program instructions. In some embodiments, the cleaning module 76 may be configured to manage cleaning of the catheter line 32 and the catheter assembly 16. In some embodiments, the cleaning module 76 may be configured to monitor fluid flow through the catheter assembly 16. The processor 66 may retrieve the program instructions for the cleaning module 76 from the data store 70 and load the program instructions for the cleaning module 76 into the memory 68. After the program instructions for the cleaning module 76 are loaded into the memory 68, the processor 66 may execute the program instructions and the computing system 64 may perform operations associated with the cleaning module 76 as indicated by the instructions.

[0041] Memory 68 and data storage 70 may comprise computer-readable storage media for holding or having computer-executable instructions or data structures stored thereon. Such computer-readable storage media may comprise any available media that can be accessed by a general-purpose or special-purpose computer, such as processor 66. For example, and without limitation, such computer-readable storage media may be used to execute or store desired program code in the form of computer-executable instructions or data structures stored thereon, and may comprise tangible or non-transitory computer-readable storage media, including any other available media 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 comprise, for example, instructions or data arranged to cause processor 66 to perform a certain operation or group of operations.

[0042] In some embodiments, one or more physician monitoring devices 73 may be coupled to computing system 64 via network 78. In these and other embodiments, network 78 may comprise a wired or wireless network and may have any suitable structure, such as a star structure, a token ring structure, or other structure. Additionally, in some embodiments, network 78 may comprise an Ethernet network, a local area network (LAN), a wide area network (WAN) (e.g., the Internet), and / or other interconnected data path access to multiple devices that may communicate. In some embodiments, network 78 may couple with or comprise portions of a communications network that may enable data communications in a number of different communications protocols. In some embodiments, physician monitoring device 73 may comprise or correspond to any of physician monitoring devices 46 described with respect to FIG. 2.

[0043] In some embodiments, network 78 may comprise a BLUETOOTH® communications network and / or a cellular communications network for transmitting and receiving data, including via Short Message Service (SMS), Multimedia Message Service (MMS), Hypertext Transfer Protocol (HTTP), Direct Data Connection, Wireless Application Protocol (WAP), e-mail, etc. Network 78 may enable communications via standards-based protocols such as Smart Energy Profile (SEP), Echonet Lite, OpenADR, or another suitable protocol (e.g., Wireless Fidelity (Wi-Fi), ZigBee, HomePlug Green, etc.).

[0044] In some embodiments, the communication unit 72 may be configured to transmit data to and receive data from the physician monitoring device 73 via the network 78. In some embodiments, the communication unit 72 may be configured to transmit and receive data from a display screen 80 and / or an electronic health record 82. In some embodiments, the display screen 80 may comprise or correspond to the display screen 50 described with respect to FIG. 2A or 2B. In some embodiments, the electronic health record 82 may comprise or correspond to the electronic health record 52 of FIG. 2B. In some embodiments, the cleaning module 76 may be configured to transmit and receive data via the communication unit 72.

[0045] In some embodiments, the communications unit 72 may include a port for direct physical connection to the network 78 and / or another communications channel. For example, the communications unit 72 may include a Universal Serial Bus (USB) port, an 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 72 may include a wireless transceiver for exchanging data with the physician monitoring device 46 or another communications channel using one or more wireless communications methods, including IEEE 802.11, IEEE 802.16, BLUETOOTH, or another suitable wireless communications method.

[0046] In some embodiments, communications unit 72 may comprise a cellular communications transceiver for sending and receiving data over cellular communications including SMS, MMS, HTTP, direct data connection, WAP, e-mail, or another suitable type of electronic transmission. Communications unit 72 may provide other conventional connections to network 78 for delivery 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).

[0047] Specific examples of how the cleaning module 76 may manage cleaning of or monitor flow through the catheter assembly are now provided. In some embodiments, in response to one or more acoustic sensors 84 detecting that the clamp is closed, the cleaning module 76 may be arranged to initiate a timer. In some embodiments, the acoustic sensors 84 may comprise or correspond to the acoustic sensors 42 described in connection with FIG. 1 or 4. In some embodiments, in response to the timer 86 reaching a predetermined amount of time, the cleaning module 76 may be arranged to generate one or more alerts at the clamp and / or transmit an alert signal over the network 78 to the physician monitoring device 73, which may provide one or more alerts. In some embodiments, the alert may indicate any alert as described in connection with FIG. 1 and 2. In some embodiments, the alert may indicate to the physician that a medically recommended time to clean the catheter assembly has been reached or is approaching.

[0048] In some embodiments, in response to one or more acoustic sensors 84 detecting that clamp 63 is closed, cleaning module 76 may be configured to display in a patient's electronic health record 88. In some embodiments, electronic health record 88 may be stored and / or displayed on physician monitoring device 73. In some embodiments, electronic health record 88 may comprise or correspond to electronic health record 52 described in connection with FIG. 2.

[0049] In some embodiments, in response to one or more acoustic sensors 84 detecting that clamp 63 is open or has been open for another predetermined amount of time, cleaning module 76 may be arranged to stop and / or reset timer 86. In some embodiments, cleaning module 76 may be arranged to stop timer 86 only after clamp 63 has been open for another predetermined amount of time to prevent clamp 63 from opening if sufficient cleaning has not occurred.

[0050] In some embodiments, in response to the one or more acoustic sensors 84 detecting that the clamp is open for another predetermined amount of time, the cleaning module 76 may be configured to stop the alert at the clamp 63 or provide a different alert at the clamp. Additionally or alternatively, in some embodiments, in response to the acoustic sensor 84 detecting that the clamp is open for another predetermined amount of time, the cleaning module 76 may be configured to send another alert signal over the network 78 to stop the alert or provide a different alert to the physician monitoring device 73. In some embodiments, the cleaning module 76 may be configured to provide another indication in the patient's electronic health record 88 in response to the one or more acoustic sensors 88 detecting that the clamp 63 is open for another predetermined amount of time.

[0051] In some embodiments, in response to one or more acoustic sensors detecting fluid flow through the extension tube of the catheter assembly, the flushing module 76 may be configured to stop or reset the timer 86. In some embodiments, the external server may comprise one or more components of the computing system 64. For example, the external server may comprise the processor 66. In some embodiments, the external server may be connected to the clamp 63 and / or the physician monitoring device 73 via the network 78 or another network. Modifications, additions, or deletions may be made to the FM system 62 without departing from the scope of the present disclosure.

[0052] 4A-4B, a clamp 90 is shown according to some embodiments. In some embodiments, the clamp 90 may comprise or correspond to the lamp 36 described in connection with FIG. 1. In some embodiments, the clamp 90 may replace the clamp 36 in FIG. 1. In some embodiments, the extension tube 34 of the catheter system of FIG. 1 may extend through the clamp 90.

[0053] In some embodiments, the clamp 90 may not comprise a clamping clamp. In some embodiments, the clamp 90 may be positioned to clamp the extension tube 34 or stop the flow of fluid through the extension tube 34. In some embodiments, the clamp 90 may encircle the extension tube 34 when the clamp 90 is in a closed position.

[0054] In some embodiments, the extension tube 34 may include a clamp 90 and / or a clamping clamp. In some embodiments, the clamp 90 may include any suitable extension tube. In some embodiments, the clamp 90 may be placed on an IV line that may extend between an IV bag and the catheter assembly 16. In some embodiments, a peripherally inserted central catheter ("PICC") assembly may include a pigtail extension tube, and a special clamp 90 may be coupled to one or more of the pigtail extension tubes.

[0055] In some embodiments, the clamp 90 may open via one or more hinges 92 or another suitable mechanism. In some embodiments, the clamp 90 may include a channel 94 extending therethrough. In some embodiments, the outer diameter of the extension tube 34 may be slightly smaller than the diameter of the channel 94. In some embodiments, the extension tube 34 may contact the channel 94.

[0056] In some embodiments, the portion of the acoustic sensor 42 may vary. In some embodiments, the acoustic sensor 42 may be embedded in a channel 94. In some embodiments, the acoustic sensor 42 may contact the extension tube 34 when the clamp 90 is in the closed position, as shown, for example, in FIG. 4B. In some embodiments, the acoustic sensor 42 may be spaced from the extension tube 34 when the clamp 89 is in the closed position.

[0057] In some embodiments, the first acoustic sensor 42a and the second acoustic sensor 42b may provide a robust determination of whether fluid is flowing through the extension tube 34 and whether the clamp 36 is open or closed. In some embodiments, the first acoustic sensor 42a may be located distal to the second acoustic sensor 42b. In some embodiments, the direction of fluid flow in the extension tube 34 may be determined in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before or after the other acoustic sensor 42b detecting fluid flow through the extension tube 34. In some embodiments, the direction of fluid flow may be determined to be proximal in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before the second acoustic sensor 42b. In some embodiments, the direction of fluid flow may be determined to be distal in response to the second acoustic sensor 42b detecting fluid flow through the extension tube 34 before the first acoustic sensor 42a.

[0058] In some embodiments, the acoustic sensor 42 may be electrically coupled to a circuit board 43 and a charger 44. In some embodiments, the locations of the circuit board 43 and the charger 44 may vary. In some embodiments, the circuit board 43 may include a transmitting unit.

[0059] 5A, an exemplary waveform 98 produced by an acoustic sensor is shown, according to some embodiments. In some embodiments, a flow portion 100 of the waveform 98 may indicate fluid flow through an extension tube, such as the extension tube 34, as described with respect to FIGS. 1 and 2. In some embodiments, a non-flow portion 102 of the waveform 98 may indicate that fluid is not flowing through the extension tube 34 or that a clamp is closed.

[0060] In some embodiments, the flow of fluid through the extension tube may be determined based on the presence of a flow segment 100, which may have one or more of the following distinct signatures: a characteristic frequency, a characteristic amplitude, a length, and a characteristic sound energy. In further detail, in some embodiments, the distinct signature of the flow segment 100 may comprise a characteristic frequency, such as, for example, a maximum or peak frequency, multiple occurrences of a maximum or peak frequency over a period of time, or an average frequency over a period of time. Additionally or alternatively, in some embodiments, the distinct signature of the flow segment 100 may comprise a characteristic amplitude, such as, for example, a maximum or peak amplitude, multiple occurrences of a maximum or peak amplitude over a period of time, or an average amplitude over a period of time. In some embodiments, one or more of the following distinct signatures of the flow segment 100 may be greater than or equal to one or more threshold values: a characteristic frequency, a characteristic amplitude, and a characteristic sound energy. In some embodiments, the amplitude or frequency may be absent, such as, for example, a person speaking or an alert, and is not associated with the flow of fluid.

[0061] In some embodiments, the threshold depends on one or more of the following: the wall thickness of the extension tube, the distance of the acoustic sensor from the extension tube, the material from which the extension tube is constructed, the gauge size of the extension tube, and the catheter, such as catheter 20 shown with respect to FIG. 1. In further detail, in some embodiments, the threshold may vary depending on the characteristics of the extension tube, such as the wall thickness of the extension tube, the material from which the extension tube is constructed, and the gauge size of the extension tube. In some embodiments, the threshold may be measured prior to inserting the catheter into the patient by flushing the catheter with fluid, such that the fluid flows through the extension tube of the catheter system and is detected by the acoustic sensor.

[0062] In some embodiments, the lack of fluid flow through the extension tube may be determined based on the presence of a non-flow portion 102, which may have a distinct signature including one or more of the following: a distinct characteristic frequency, a distinct characteristic amplitude, a length, and a distinct characteristic sound energy. In further detail, in some embodiments, the distinct signature of the non-flow portion 102 may comprise another characteristic frequency, such as, for example, a maximum or peak frequency, multiple occurrences of a maximum or peak frequency over a period of time, or an average frequency over a period of time. Additionally or alternatively, in some embodiments, the distinct signature of the non-flow portion 102 may comprise another characteristic amplitude, such as, for example, a maximum or peak amplitude, multiple occurrences of a maximum or peak amplitude over a period of time, or an average amplitude over a period of time. In some embodiments, one or more of the following distinct signatures of the non-flow portion 102 may be less than one or more threshold values: a distinct characteristic frequency, a distinct characteristic amplitude, and a distinct characteristic sound energy. In some embodiments, the amplitude or frequency may be absent, such as, for example, a person speaking or an alert, and is not associated with fluid flow.

[0063] In some embodiments, the fluid flow through the extension tube may be determined in response to the acoustic sensor detecting one or more of the following: a particular frequency greater than a particular threshold, or a particular amplitude greater than a particular threshold, or a particular sound energy greater than a particular threshold. In some embodiments, the particular frequency may comprise a maximum or peak frequency, multiple occurrences of a maximum or peak frequency over a period of time, or an average frequency over a period of time. In some embodiments, the particular amplitude may comprise a maximum amplitude, multiple occurrences of a maximum or peak amplitude over a period of time, or an average amplitude over a period of time. In some embodiments, the particular sound energy may be based on the sum of the integrated potential and velocity energy densities over the volume of interest.

[0064] In some embodiments, it may be determined that fluid is not flowing through the extension tube in response to the acoustic sensor detecting one or more of the following: a particular frequency less than a particular threshold, a particular amplitude less than a particular threshold, or a particular sound energy less than a particular threshold. In some embodiments, the particular frequency may comprise a particular frequency, such as a maximum or peak frequency, multiple occurrences of a maximum or peak frequency over a period of time, or an average frequency over a period of time. In some embodiments, the particular amplitude may comprise a maximum or peak amplitude, multiple occurrences of a maximum or peak amplitude over a period of time, or an average amplitude over a period of time.

[0065] As now shown in FIG. 5A, in some embodiments, the peak amplitude of the non-flow portion 102 may be between about −18 dB and about −24 dB, which may be used as a threshold value. In these and other embodiments, the peak amplitude of the flow portion 100 may be higher, such as, for example, about 0 dB, about −2 dB, or about −5 dB, which may be used as a threshold value. In some embodiments, the flow portion 100 may correspond to a frequency between about 80 and about 200 Hz, which may be used as a threshold value. In some embodiments, the non-flow portion 102 may correspond to a frequency between about 40 and about 80 Hz, which may be used as a threshold value. In some embodiments, the waveform 98 in FIGS. 5A-5B may correspond to a standard plastic extension tube, such as, for example, a Becton Dickinson NEXIVA™ closed IV catheter system or similar catheter system, with an acoustic sensor located at or near the proximal end of the extension tube. It is understood that a variety of scales may be used, including seconds, milliseconds, or other units of time on the x-axis, and decibels, or other units of time on the y-axis.

[0066] 5B, in some embodiments, an example waveform 104 generated by a first acoustic sensor and an example waveform 106 generated by a second acoustic sensor are shown. In some embodiments, the first acoustic sensor may be located distally or proximally relative to the second acoustic sensor.

[0067] In some embodiments, the direction of fluid flow within an extension tube, such as extension tube 34 as described with respect to Figures 1 and 2, may be determined in response to a first acoustic sensor detecting fluid flow through the extension tube before or after another acoustic sensor detects fluid flow through the extension tube. For example, a first acoustic sensor may detect fluid flow through the extension tube, as shown in Figure 5B, before a second acoustic sensor detects fluid flow through the extension tube, as shown by flow portion 100 of waveform 104 occurring at an earlier time than flow portion 100 of waveform 106. In some embodiments, flow portion 100 of waveform 104 may be spaced from flow portion 100 of waveform 106 due to a time delay.

[0068] In some embodiments, the time delay 108 shown in FIGURE 5B in response to the first acoustic sensor being disposed distally relative to the second acoustic sensor may indicate fluid flowing through the extension tube in a proximal direction. In some embodiments, the time delay 108 shown in FIGURE 5B in response to the first acoustic sensor being disposed proximally relative to the second acoustic sensor may indicate fluid flowing through the extension tube in a distal direction.

[0069] Again, it is understood that a variety of scales may be used, including seconds, milliseconds, or other units of time on the x-axis, and decibels, or other units of time on the y-axis. In some embodiments, the time delay 108 may be less than a few milliseconds or less than a few microseconds. In some embodiments, the time delay 108 may be based on the distance between the first acoustic sensor and the second acoustic sensor, which may vary. In some embodiments, the first acoustic sensor and / or the second acoustic sensor may detect a distance or time delay between one or more peaks in the waveform 104 and the waveform 106, which may indicate fluid flowing through the extension tube in a particular direction. For example, if the first acoustic sensor detects one or more peaks before the second acoustic sensor detects one or more peaks, it may be determined that fluid is flowing in a proximal direction.

[0070] All examples and conditional language described herein are intended for educational purposes to aid the reader in understanding the concepts contributed by the inventor to further the invention and the art, and should be construed as having no limitations on such specifically described examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions, and alterations can be made herein without departing from the spirit and scope of the invention.

Claims

1. 1. A method for monitoring fluid flow through a catheter assembly, the method comprising: providing a clamp arranged to clamp an extension tube of a catheter assembly, the clamp comprising an acoustic sensor arranged to detect fluid flow through the extension tube, the clamp and the acoustic sensor being disposed on an exterior of the extension tube; and detecting fluid flow through the extension tube via an acoustic sensor.

2. 2. The method of claim 1, wherein detecting fluid flow through the extension tube via an acoustic sensor includes detecting a frequency of fluid flow through the extension tube, an amplitude of fluid flow through the extension tube, or a sound energy of fluid flow through the extension tube via the acoustic sensor.

3. 10. The method of claim 1, wherein detecting fluid flow through the extension tube via an acoustic sensor comprises detecting a frequency between 80 Hz and 200 Hz via the acoustic sensor.

4. 10. The method of claim 1, further comprising detecting a lack of fluid flow through the extension tube via an acoustic sensor.

5. 5. The method of claim 4, wherein detecting via the acoustic sensor that no fluid flows through the extension tube comprises detecting via the acoustic sensor a frequency between 40 Hz and 80 Hz.

6. The method of claim 4, further comprising: initiating a timer in response to detecting via the acoustic sensor that no fluid flows through the extension tube; and In response to the timer reaching a predetermined amount of time, providing an alert.

7. 7. The method of claim 6, wherein the step of providing an alert comprises transmitting an alert signal over a network to the monitoring device, the alert signal instructing the monitoring device to provide the alert.

8. 7. The method of claim 6, further comprising providing an indication in the patient's electronic health record in response to the timer reaching the predetermined amount of time.

9. 7. The method of claim 6, further comprising stopping or resetting the timer in response to detecting fluid flow through the extension tube via the acoustic sensor for another predetermined amount of time.

10. 10. The method of claim 9, further comprising sending another alert signal over the network to the monitoring device in response to the acoustic sensor detecting fluid flow through the extension tube for another predetermined length of time via the acoustic sensor, the other alert signal instructing the monitoring device to stop the alert or provide another alert.

11. 7. The method of claim 6, further comprising providing a different alert in response to the timer reaching a different predetermined amount of time.

12. 12. The method of claim 11, wherein the other predetermined length of time is greater than the predetermined length of time and corresponds to a time of flow through the catheter assembly, the other predetermined length of time being between about 6 hours and about 8 hours.

13. 10. The method of claim 1, further comprising providing an indication in the patient's electronic health record in response to detecting fluid flowing or not flowing through the extension tube via the acoustic sensor.

14. 10. The method of claim 1, wherein the clamp comprises another acoustic sensor disposed to detect fluid flow through the extension tube, the other acoustic sensor disposed outside the extension tube and the acoustic sensor disposed distally relative to the other acoustic sensor, and further comprising determining a direction of fluid flow in response to detecting fluid flow through the extension tube via the other acoustic sensor before or after fluid flow through the extension tube.

15. The method of claim 1 , wherein the clamp is a clamping clamp.

16. 1. A catheter assembly comprising: Catheter adapter, an extension tube connected to the catheter adapter; and a clamp disposed on the extension tube, the clamp comprising an acoustic sensor disposed to detect fluid flow through the extension tube; Catheter assembly.

17. 17. A catheter assembly according to claim 16, The catheter assembly, wherein the clamp comprises a clamping clamp and the acoustic sensor is embedded in the clamping clamp.

18. 17. A catheter assembly according to claim 16, The catheter assembly, wherein the clamp comprises a non-constricting clamp, the clamp having a channel extending therethrough, and the acoustic sensor is embedded in the channel.

19. 1. An extension set for a catheter assembly, comprising: A clamp comprising an acoustic sensor; and an extension tube extending through the clamp; The acoustic sensor is an extension set positioned to detect fluid flow through the extension tube.

20. 20. The extension set of claim 19, The clamp includes another acoustic sensor. The other acoustic sensor is disposed proximally relative to the acoustic sensor, an extension set.

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