Catheter Assembly Clamp with Sound Sensor

Abstract

The present disclosure relates to a method for managing the flushing of a catheter assembly, the catheter assembly including a clamp configured to grip an extension tube of the catheter assembly. The clamp may include a sound sensor configured to detect fluid flow through the extension tube. The clamp and the sound sensor may be disposed outside the extension tube. The clamp may include a pinch clamp or a non-pinch clamp. The sound sensor may be embedded in the clamp. The method may include detecting fluid flow through the extension tube via the sound sensor.

Description

Technical Field

[0001] The present disclosure relates to the field of medical devices. More particularly, the present disclosure relates to vascular access systems and related devices and methods. Background Art

[0002] Catheters are commonly used in various infusion therapies. For example, a catheter can be used to infuse fluids such as saline solutions, various drugs, and total parenteral nutrition into a patient. A catheter can also be used to draw blood from a patient.

[0003] Common types of catheters include over-the-needle peripheral intravenous catheters ("PIVCs"), peripherally inserted central catheters ("PICCs"), or midline catheters. As the name implies, an over-the-needle catheter can be mounted over a guide needle having a sharp distal tip. The sharp distal tip can be used to pierce the skin and vasculature of a patient. The catheter can be inserted into the vasculature after the needle has pierced the vasculature. The needle and catheter are typically inserted into the patient's vasculature through the skin at a relatively shallow angle, and the bevel of the needle faces away from the patient's skin. Once the placement of the needle in the vasculature is confirmed, the clinician can temporarily occlude the flow in the vasculature and withdraw the needle, leaving the catheter in place for future blood draws and / or infusions.

[0004] In some cases, a catheter may become unusable or damaged due to blockage over time. In response to the catheter beginning to become blocked, the catheter may need to be removed and replaced with a new catheter. Catheter blockage can be thrombotic, which is caused by a blood clot formed inside or around the distal tip of the catheter. Catheter blockage can also be non-thrombotic, which is caused by precipitation, mechanical blockage, and other factors. In addition, catheter blockage can lead to catheter infections, pulmonary embolisms, post-thrombotic syndrome, and other negative health consequences. Clinicians can flush the catheter regularly to prevent blockage and extend the dwell time of the catheter.

[0005] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or operate only in environments such as those described above. Rather, this background art is only provided to illustrate one example technical field in which some implementations described herein may be practiced. Summary of the Invention

[0006] The present disclosure generally relates to vascular access systems and related devices and methods. In some embodiments, a method for managing flushing of a catheter assembly can include providing a clamp for an extension tube of the catheter assembly. In some embodiments, the clamp can include a sound sensor that can be configured to detect when the clamp is open or when fluid is flowing through the extension tube of the catheter assembly. In some embodiments, the sound sensor can be configured to detect when the clamp is closed or when fluid is not flowing through the extension tube of the catheter assembly.

[0007] In some embodiments, the method may include starting a timer in response to a sound sensor detecting that a clamp is closed. In some embodiments, the method may include providing an alert in response to the timer reaching a predetermined duration. In some embodiments, the alert may indicate to a clinician that the catheter assembly should be opened and flushed, thereby preventing blockage of the catheter assembly.

[0008] In some embodiments, providing the alert may include sending an alert signal over a network to a monitoring device (such as a clinician monitoring device). In some embodiments, the alert signal may instruct the monitoring device to provide an alert. In some embodiments, the alert may include an audible sound, a tactile vibration, or a visual cue. In some embodiments, the visual cue may include a change in the state of a light. In some embodiments, in response to the sound sensor detecting that the clamp is closed, an indication may be provided in the patient's electronic health record.

[0009] In some embodiments, the sound sensor may be configured to detect that the clamp is open. In some embodiments, in response to the sound sensor detecting that the clamp has been open for another predetermined duration, the timer may be stopped and / or reset. In some embodiments, in response to the sound sensor detecting that the clamp has been open for the other predetermined duration, another alert signal may be sent over a network to the monitoring device to stop the alert or provide another alert. In some embodiments, in response to the sound sensor detecting that the clamp has been open for the other predetermined duration, another indication may be provided in the patient's electronic health record.

[0010] In some embodiments, another sound sensor may be provided. In some embodiments, the sound sensor and the other sound sensor may reliably determine whether fluid is flowing through the extension tube and whether the clamp has been opened or closed. In some embodiments, the sound sensor may be disposed distal to the other sound sensor. In some embodiments, in response to the sound sensor detecting fluid flow through the extension tube before or after the other sound sensor detects fluid flow through the extension tube, the direction of fluid flow within the extension tube may be determined. In some embodiments, in response to the other sound sensor detecting that the clamp is open and fluid is flowing through the extension tube of the catheter assembly, the timer may be stopped and / or reset.

[0011] The objects and advantages of these embodiments will be realized and attained at least by the elements, features, and combinations particularly pointed out in the claims. It should be understood that 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

[0012] The example embodiments will be described and illustrated with additional features and details by using the accompanying drawings, in which:

[0013] Figure 1A is a top perspective view of an exemplary catheter system in accordance with some embodiments;

[0014] Figure 1B is a top perspective view of an exemplary clamp in accordance with some embodiments, showing the clamp in an open position;

[0015] Figure 1C is in accordance with some embodiments Figure 1B of a clamp, showing the clamp in a closed position;

[0016] Figure 2A is a top perspective view of an exemplary clinician monitoring device in accordance with some embodiments;

[0017] Figure 2B is an exemplary electronic health record that may be presented on a display screen of a clinician monitoring device in accordance with some embodiments;

[0018] Figure 3 is a block diagram of an exemplary irrigation management system in accordance with some embodiments;

[0019] Figure 4A is another exemplary clamp that may be used with Figure 1A the catheter system, showing the clamp in an open position;

[0020] Figure 4B is Figure 4A of a clamp, showing the clamp in a closed position;

[0021] Figure 5A is a view of an exemplary waveform generated by a sound sensor; and

[0022] Figure 5B is a view of exemplary waveforms generated by two sound sensors. DETAILED DESCRIPTION

[0023] Now referring to Figure 1A , there is shown an exemplary catheter system 14 in accordance with some embodiments. In some embodiments, catheter system 14 may include a catheter assembly 16. In some embodiments, catheter assembly 16 may include a catheter adapter 18 and a catheter 20 extending distally from catheter adapter 18. In some embodiments, catheter adapter 18 may include a side port 22 that is in fluid communication with the lumen of catheter adapter 18. In some embodiments, catheter adapter 18 may include a proximal end 23, a distal end 24, and a lumen extending therebetween. In some embodiments, catheter 20 may include a PIVC.

[0024] In some embodiments, the catheter assembly 16 may be removably coupled to a needle assembly that may include a needle hub 26 and a guide needle 28. In some embodiments, the guide needle 28 may include a sharp distal tip 30. In some embodiments, the proximal end of the guide needle 28 may be fixed within the needle hub 26.

[0025] In some embodiments, such as Figure 1A shown, when the catheter assembly 16 is in an insertion position ready to be inserted into a patient's vasculature, the guide needle 28 may extend through the catheter 20. In some embodiments, in response to the guide needle 28 being inserted into the patient's vasculature, a blood flashback may flow through the sharp distal tip 30 of the guide needle 28 and may be visible to a clinician between the guide needle 28 and the catheter 20 and / or at another location within the catheter assembly 16.

[0026] In some embodiments, in response to confirming that the catheter 20 is within the patient's vasculature via a blood flashback, the needle assembly may be removed from the catheter assembly 16. In some embodiments, such as Figure 1A shown, when the needle assembly is coupled to the catheter assembly 16, the guide needle 28 of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter 18.

[0027] In some embodiments, the catheter system 14 may include a catheter line 32 that may include an extension tube 34 and a clamp 36 through which the extension tube 34 may extend. In some embodiments, such as Figure 1A shown, the distal end of the extension tube 34 may be integrally formed with the catheter adapter 18. For example, the extension tube 34 may be integrally formed with a side port 24 of the catheter adapter 18. In some embodiments, the extension tube 34 may be removably coupled to the catheter adapter 18. In some embodiments, the clamp 36 may selectively close the extension tube 34 to prevent blood or other fluid from flowing through the extension tube 34.

[0028] 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 - shaped 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 fluid administration or blood withdrawal. The medical device may include a blood transfusion bag, a syringe, or any other suitable medical device.

[0029] In some embodiments, the catheter system 14 may include 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 disposed on an intravenous line that may extend between an intravenous bag and the catheter assembly 16. In some embodiments, the catheter assembly 16 may include a PIVC, a PICC, or a midline catheter. In some embodiments, a peripherally inserted central catheter (“PICC”) assembly may include a pigtail extension tube, and a particular clamp 36 may be coupled to one or more pigtail extension tubes.

[0030] In some embodiments, the extension kit may be configured to be directly or indirectly coupled to the catheter assembly 16. In some embodiments, the extension kit may include an intravenous line, the extension tube 34, or any other extension tube in fluid communication with the catheter assembly 16. In some embodiments, the extension kit may include the clamp 36.

[0031] Now referring Figure 1B , in response to the clamp 36 being opened, fluid may flow through the extension tube 34 and the catheter assembly 16. For example, fluid may be infused into a patient through a medical device coupled to the adapter 38, or blood may be withdrawn from the patient into a blood collection device coupled to the adapter 38. In some embodiments, the clamp 36 may include a first sound sensor 42a and / or a second sound sensor 42b (which may be collectively referred to as “sound sensors 42” in the present disclosure). In some embodiments, each sound sensor 42 may be configured to detect fluid flowing through the extension tube 34 or the clamp 36 being opened. In some embodiments, each sound sensor 42 may be configured to detect fluid not flowing through the extension tube 34 or the clamp 36 being closed. In some embodiments, the first sound sensor 42a and / or the second sound sensor 42b may include one or more microphones.

[0032] In some embodiments, the first acoustic sensor 42a and the second acoustic sensor 42b can reliably determine 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 can be disposed distally of the second acoustic sensor 42b. In some embodiments, in response to the first acoustic sensor 42a detecting fluid flow through the extension tube 34 before or after the second acoustic sensor 42b detects fluid flow through the extension tube 34, the direction of fluid flow within the extension tube 34 can be determined. In some embodiments, before the second acoustic sensor 42b detects fluid flowing through the extension tube 34, in response to the first acoustic sensor 42a detecting fluid flowing through the extension tube 34, the direction of fluid flow can be determined to be proximal. In some embodiments, in response to the second acoustic sensor 42b detecting fluid flowing through the extension tube 34 prior to the first acoustic sensor 42a, the direction of fluid flow can be determined to be distal.

[0033] In some embodiments, the acoustic sensor 42 can be electrically coupled to the circuit board 43 and the battery 44. In some embodiments, the positions of the circuit board 43 and the battery 44 can vary. In some embodiments, the circuit board 43 can include a communication unit.

[0034] Now referring Figure 1C , in response to the clamp 36 being closed, fluid flow through the extension tube 34 can be prevented. In some embodiments, in response to the clamp 36 being closed, substantially all fluid flow through the extension tube 34 can be prevented. In some embodiments, the clamp 36 can include a pinch clamp that can pinch the extension tube 34 in response to the clamp 36 moving to the closed position.

[0035] In some embodiments, the clamp 36 can include any clamp that couples 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 on October 5, 2016, with the title "PINCH CLAMP DEVICE", the entire contents of which are incorporated herein by reference. In some embodiments, the extension tube 34 can extend through the clamp 36. In some embodiments, the clamp 36 can include an arm 47 that can include a protrusion that contacts and pinches the extension tube 34. In some embodiments, the clamp 36 can include any suitable clamp, and the acoustic sensor 42 can include any suitable acoustic sensor. In some embodiments, the acoustic sensor 42 can be disposed at various locations.

[0036] In some embodiments, the sound sensor 42 can be embedded in the clamp 36. In these and other embodiments, one or more sound sensors 42 can contact the extension tube 34. In some embodiments, one or more sound sensors 42 can be spaced apart from the extension tube 34. In some embodiments, the first sound sensor 42a can be disposed distally of the second sound sensor 42b.

[0037] In some embodiments, the position of the sound sensor 42 can vary. In some embodiments, the sound sensor 42 can be disposed on the clamping surface of the clamp 36 that contacts the extension tube 34 when the clamp 36 is in the open position and / or the closed position. In some embodiments, the clamping surface can be generally flat or curved. In some embodiments, the sound sensor 42 can be disposed on a non-clamping surface. In some embodiments, the sound sensors 42 can be disposed on opposite sides of the extension tube 34. In some embodiments, the sound sensors 42 can be disposed on the same side of the extension tube 34.

[0038] In some embodiments, the clamp 36 can provide an alarm, which can include a sound, a tactile vibration, or a visual cue. In some embodiments, the visual cue can include a change in the state of a light. Figure 1B - 1C An exemplary light 48 is shown in accordance with some embodiments. In some embodiments, the state of the light 48 can change in response to the clamp 36 being closed for a predetermined duration. For example, the light 48 can turn on or change color in response to the clamp 36 being closed for a predetermined duration. As another example, the light 38 can blink or change the rate of blinking in response to the clamp 36 being closed for a predetermined duration.

[0039] In some embodiments, the predetermined duration can correspond to a time before the clinically recommended time for flushing the catheter assembly 16. In these embodiments, the alarm can include a warning that can indicate to the clinician that the clinically recommended time for flushing the catheter assembly 16 is approaching. In some embodiments, the clinically recommended time for flushing the catheter assembly 16 can be between about 6 hours and about 8 hours from the previous flushing of the catheter assembly 16.

[0040] In some embodiments, the predetermined duration can correspond to the clinically recommended time for flushing the catheter assembly 16. In some embodiments, the clamp 36 can provide a first alarm in response to the clinically recommended time for flushing the catheter assembly 16 approaching (e.g., within 30 minutes, 10 minutes, or 5 minutes), and the clamp 36 can provide a second alarm in response to the clinically recommended time for flushing the catheter assembly 16 having arrived. In some embodiments, the first alarm can include a yellow or orange light, and the second alarm can include a red light.

[0041] In some embodiments, the lamp 48 can be disposed at different positions on the fixture 36 that can be seen by the clinician. In some embodiments, the fixture 36 can include multiple lamps 48. In some embodiments, the size of the lamp 48 can vary.

[0042] Now referring Figure 2A , an exemplary clinician monitoring device 46 according to some embodiments is shown. Examples of the clinician monitoring device 46 can include a computing device, a mobile phone, a smartphone, a tablet computer, a laptop computer, a desktop computer, a medical device, or a connected device (such as a smartwatch, smart glasses, or any other connected device). In some embodiments, in addition to or as an alternative to the fixture 36, the clinician monitoring device 46 can provide an alert.

[0043] In some embodiments, the clinician monitoring device 46 can include a display screen 50, and the display screen 50 can provide an alert. In some embodiments, the alert can include a phrase, such as "Rinse period has arrived". In some embodiments, the alert can include a visual cue on the display screen 50, such as a portion of the display screen 50 lighting up or changing color. In some embodiments, this portion of the display screen 50 can blink or change the blinking rate to provide an alert. In some embodiments, for example, as described with respect to Figure 1C , the clinician monitoring device 46 can include a lamp 48.

[0044] Now referring Figure 2B , an exemplary electronic health record 52 that can be presented on the display screen 50 of the clinician monitoring device 46 according to some embodiments is shown. In some embodiments, an indication can be provided on the display screen 50 in response to the opening and / or closing of the fixture 36. In some embodiments, an indication can be provided on the display screen 50 in response to the fixture 36 having been open for a specific predetermined duration and / or the fixture 36 having been closed for a specific predetermined duration.

[0045] In some embodiments, the indication can include one or more of the following: a time point 56, a status 58, and a duration 60. In some embodiments, the duration 60 can include the duration for which the fixture 36 has been closed. In some embodiments, the status 58 can include "open" and can be adjacent to the time point 56, thereby indicating to the clinician the time point at which the fixture 36 was opened. In some embodiments, the status 58 can include "closed" and can be adjacent to the time point 56, thereby indicating to the clinician the time point at which the fixture 36 was closed.

[0046] Figure 3It is a block diagram of an exemplary Flush Management System (FM system) 62 arranged according to at least one embodiment described in the present disclosure. In some embodiments, the FM system 62 may include a clamp 63. In some embodiments, the clamp 63 may include or correspond to the clamp 36 described with reference to FIG. 1 or the clamp 90 described with reference to FIG. 4. The clamp 63 may include a computing system 64.

[0047] In some embodiments, the computing system 64 may include a processor 66, a memory 68, a data storage device 70, and a communication unit 72. In some embodiments, the processor 66, the memory 68, the data storage device 70, and the communication unit 72 may be communicatively coupled via 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, or the like, 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.

[0048] Generally, the processor 66 may include any suitable dedicated or general-purpose computer, computing entity, or processing device including various computer hardware or software modules, and may be configured to execute instructions stored on any applicable computer-readable storage medium. For example, the processor 66 may include a microprocessor, a microcontroller, a Digital Signal Processor (DSP), an Application Specific Integrated Circuit (ASIC), a Field Programmable Gate Array (FPGA), or any other digital or analog circuit for interpreting and / or executing program instructions and / or processing data. Although shown as a single processor in Figure 3 the processor 66 may include any number of processors configured to perform any number of operations described in the present disclosure, either individually or jointly. Additionally, one or more processors 66 may be present on one or more different electronic devices.

[0049] In some embodiments, the processor 66 may interpret and / or execute program instructions and / or process data stored in the memory 68, the data storage device 70, or both the memory 68 and the data storage device 70. In some embodiments, the processor 66 may obtain program instructions from the data storage device 70 and load the program instructions into the memory 68. In some embodiments, after loading the program instructions into the memory 68, the processor 66 may execute the program instructions.

[0050] For example, in some embodiments, the flush module 76 may be included in the data storage device 70 as program instructions. In some embodiments, the flush module 76 may be configured to manage the flushing of the catheter line 32 and the catheter assembly 16. In some embodiments, the flush module 76 may be configured to monitor the fluid flowing through the catheter assembly 16. The processor 66 may obtain the program instructions of the flush module 76 from the data storage device 70 and may load the program instructions of the flush module 76 into the memory 68. After loading the program instructions of the flush module 76 into the memory 68, the processor 66 may execute the program instructions so that the computing system 64 can perform operations associated with the flush module 76 as indicated by the instructions.

[0051] The memory 68 and the data storage device 70 may include computer-readable storage media for carrying or containing 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 or special purpose computer such as the processor 66. 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 devices, flash memory devices (e.g., solid state storage devices), or any other storage media that can be used to carry or store the desired program code in the form of computer-executable instructions or data structures and that can be accessed by a general 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 the processor 66 to perform a certain operation or a set of operations.

[0052] In some embodiments, one or more clinician monitoring devices 73 may be connected to the computing system 64 via the network 78. In these and other embodiments, the network 78 may include a wired or wireless network and may have any suitable configuration, such as a star configuration, a token ring configuration, or other configuration. Additionally, in some embodiments, the network 78 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 can communicate. In some embodiments, the network 78 may include a peer-to-peer network. In some embodiments, the network 78 may also be coupled to or include portions of a telecommunications network that may enable data communication using a variety of different communication protocols. In some embodiments, the clinician monitoring device 73 may include or correspond to any of the clinician monitoring devices 46 described with reference to FIG. 2.

[0053] In some embodiments, network 78 may include a Bluetooth® communication network and / or a cellular communication network for sending and receiving data via, including Short Message Service (SMS), Multimedia Messaging Service (MMS), Hypertext Transfer Protocol (HTTP), direct data connection, Wireless Application Protocol (WAP), and email. Network 78 may enable communication via standards-based protocols (such as Smart Energy Profile (SEP), Echonet Lite protocol, OpenADR protocol) or another suitable protocol (such as, Wireless Fidelity (Wi-Fi), ZigBee, HomePlug Green, etc.).

[0054] In some embodiments, communication unit 72 may be configured to send data to and receive data from clinician monitoring device 73 via network 78. In some embodiments, communication unit 72 may also be configured to send and receive data from display screen 80 and / or electronic health record 82. In some embodiments, display screen 80 may include or correspond to the display screen 50 described with reference to Figure 2A or 2B. In some embodiments, electronic health record 82 may include or correspond to Figure 2B the electronic health record 52. In some embodiments, irrigation module 76 may be configured to send and receive data via communication unit 72.

[0055] In some embodiments, communication unit 72 may include ports for direct physical connection to network 78 and / or another communication channel. For example, communication unit 72 may include a Universal Serial Bus (USB) port, a Secure Digital (SD) port, a Category 5 cable (CAT-5) port, or a similar port for wired communication with another device. In some embodiments, communication unit 72 may include a wireless transceiver for exchanging data with clinician monitoring device 46 or other communication channels using one or more wireless communication methods (including IEEE802.11, IEEE 802.16, Bluetooth®, or another suitable wireless communication method).

[0056] In some embodiments, communication unit 72 may include a cellular communication transceiver for sending and receiving data via a cellular communication network via, including SMS, MMS, HTTP, direct data connection, WAP, email, or another suitable type of electronic communication. By using standard network protocols including Transmission Control Protocol / Internet Protocol (TCP / IP), HTTP, Secure HTTP (HTTPS), and Simple Mail Transfer Protocol (SMTP), communication unit 72 may also make other conventional connections with network 78 for distributing files or media objects.

[0057] Examples are now provided of how the flush module 76 may manage flushing of the catheter assembly or monitor fluid flow through the catheter assembly. In some embodiments, in response to one or more acoustic sensors 84 detecting clamp closure, the flush module 76 may be configured to initiate a timer 86. In some embodiments, the acoustic sensor 84 may include or correspond to the acoustic sensor 42 described with reference to FIG. 1 or FIG. 4. In some embodiments, in response to the timer 86 reaching a predetermined duration, the flush module 76 may be configured to generate one or more alerts at the clamp and / or send an alert signal to the clinician monitoring device 73 via the network 78, which may provide one or more alerts. In some embodiments, the alerts may include any of the alerts described with reference to FIGS. 1 and 2. In some embodiments, the alerts may indicate to the clinician that the time clinically recommended for flushing the catheter assembly has arrived or is approaching.

[0058] In some embodiments, the flush module 76 may be configured to provide an indication in the patient's electronic health record 88 in response to the acoustic sensor 84 detecting clamp 63 closure. In some embodiments, the electronic health record 88 may be stored and / or displayed on the clinician monitoring device 73. In some embodiments, the electronic health record 88 may include or correspond to the electronic health record 52 described with reference to FIG. 2.

[0059] In some embodiments, in response to the acoustic sensor 84 detecting that the clamp 63 is open or has been open for another predetermined duration, the flush module 76 may be configured to stop and / or reset the timer 86. In some embodiments, the flush module 76 may be configured to stop the timer 86 only after the clamp 63 has been open for the other predetermined duration to prevent the clamp 63 from being opened when there may not have been sufficient flushing.

[0060] In some embodiments, in response to the acoustic sensor 84 detecting that the clamp has been open for the other predetermined duration, the flush 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 has been open for another predetermined duration, the flush module 76 may be configured to send another alert signal to the clinician monitoring device 73 via the network 78 to stop the alert or provide a different alert. In some embodiments, the flush module 76 may be configured to provide another indication in the patient's electronic health record 88 in response to the acoustic sensor 88 detecting that the clamp 63 has been open for another predetermined duration.

[0061] In some embodiments, in response to one or more sound sensors 84 detecting that fluid is flowing through the extension tube of the catheter assembly, the flushing module 76 can be configured to stop and / or reset the timer 86. In some embodiments, the external server can include one or more components of the computing system 64. For example, the external server can include the processor 66. In some embodiments, the external server can be connected to the clamp 63 and / or the clinician monitoring device 73 via the network 78 or other network connections. Without departing from the scope of the present disclosure, the FM system 62 can be modified, added to, or simplified.

[0062] Now referring Figure 4A - 4B , a clamp 90 is shown according to some embodiments. In some embodiments, the clamp 90 can include or correspond to the clamp 36 described with reference to FIG. 1. In some embodiments, the clamp 90 can replace the clamp 36 in FIG. 1. In some embodiments, the extension tube 34 of the catheter system 14 of FIG. 1 can extend through the clamp 90.

[0063] In some embodiments, the clamp 90 may not include a pinch clamp. In some embodiments, the clamp 90 may not be configured to pinch the extension tube 34 or prevent fluid from flowing through the extension tube 34. In some embodiments, when the clamp 90 is set in the closed position, the clamp 90 can surround the extension tube 34.

[0064] In some embodiments, the extension tube 34 can include the clamp 90 and / or a pinch clamp. In some embodiments, the clamp 90 can be coupled to any suitable extension tube. In some embodiments, the clamp 90 can be disposed on an intravenous line that can extend between an intravenous bag and the catheter assembly 16. In some embodiments, a peripherally inserted central catheter (“PICC”) assembly can include a pigtail extension tube, and a particular clamp 90 can be coupled to one or more pigtail extension tubes.

[0065] In some embodiments, the clamp 90 can be opened via one or more hinges 92 or another suitable mechanism. In some embodiments, the clamp 90 can include a channel 94 extending therethrough. In some embodiments, the outer diameter of the extension tube 34 can be slightly smaller than the diameter of the channel 94. In some embodiments, the extension tube 34 can contact the channel 94.

[0066] In some embodiments, the position of the sound sensor 42 can vary. In some embodiments, the sound sensor 42 can be embedded in the channel 94. In some embodiments, when the clamp 90 is in the closed position, such as Figure 4B shown in, the sound sensor 42 can contact the extension tube 34. In some embodiments, when the clamp 89 is in the closed position, the sound sensor 42 can be spaced apart from the extension tube 34.

[0067] In some embodiments, the first sound sensor 42a and the second sound sensor 42b can reliably determine whether fluid is flowing through the extension tube 34 and whether the clamp 36 is open or closed. In some embodiments, the first sound sensor 42a can be disposed distally of the second sound sensor 42b. In some embodiments, in response to the first sound sensor 42a detecting fluid flow through the extension tube 34 before or after the second sound sensor 42b detects fluid flow through the extension tube 34, the direction of fluid flow within the extension tube 34 can be determined. In some embodiments, in response to the first sound sensor 42a detecting fluid flow through the extension tube 34 prior to the second sound sensor 42b, the direction of fluid flow can be determined to be toward the proximal side. In some embodiments, in response to the second sound sensor 42b detecting fluid flow through the extension tube 34 prior to the first sound sensor 42a, the direction of fluid flow can be determined to be toward the distal side.

[0068] In some embodiments, the sound sensor 42 can be electrically coupled to the circuit board 43 and the battery 44. In some embodiments, the positions of the circuit board 43 and the battery 44 can vary. In some embodiments, the circuit board 43 can include a communication unit.

[0069] Now referring Figure 5A , an exemplary waveform 98 generated by a sound sensor is shown in accordance with some embodiments. In some embodiments, the flow portion 100 of the waveform 98 can indicate fluid flow through the extension tube (e.g., the extension tube 34 described with reference to FIGS. 1 and 2). In some embodiments, the non-flow portion 102 of the waveform 98 can indicate that fluid is not flowing through the extension tube 34 or that the clamp is closed.

[0070] In some embodiments, it can be determined that fluid is flowing through the extension tube based on the presence of the flow portion 100, and the flow portion 100 can have distinguishing features including one or more of the following: characteristic frequency, characteristic amplitude, duration, and characteristic sound energy. More specifically, in some embodiments, the distinguishing features of the flow portion 100 can include a characteristic frequency, such as a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a duration, or an average frequency over a duration. Additionally or alternatively, in some embodiments, the distinguishing features of the flow portion 100 can include a characteristic amplitude, such as a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a duration, or an average amplitude over a duration. In some embodiments, one or more of the following distinguishing features of the flow portion 100 can be greater than or equal to one or more thresholds: characteristic frequency, characteristic amplitude, and characteristic sound energy. In some embodiments, amplitudes or frequencies unrelated to fluid flow, such as human voices or alarms, can be filtered out.

[0071] In some embodiments, the threshold may depend on one or more of the following: the thickness of the wall of the extension tube, the distance from the sound sensor to the extension tube, the material of which the extension tube is constructed, and the specifications of the extension tube and the catheter (e.g., the catheter 20 described with reference to FIG. 1). More specifically, in some embodiments, the threshold may vary based on the characteristics of the extension tube (such as the thickness of the wall of the extension tube, the material of which the extension tube is constructed, and the specifications of the extension tube, etc.). In some embodiments, the threshold can be measured before inserting the catheter into a patient by infusing fluid through the catheter such that the fluid flows through the extension tube of the catheter system and is detected by the sound sensor.

[0072] In some embodiments, it may be determined that no fluid is flowing through the extension tube based on the presence of a non-flow portion 102, which may have distinguishing features including one or more of the following: another characteristic frequency, another characteristic amplitude, a duration, and another characteristic sound energy. More specifically, in some embodiments, the distinguishing features of the non-flow portion 102 may include other characteristic frequencies, such as a maximum frequency, multiple occurrences of the maximum frequency over a duration, or an average frequency over a duration. Additionally or alternatively, in some embodiments, the distinguishing features of the non-flow portion 102 may include other characteristic amplitudes, such as a maximum amplitude, multiple occurrences of the maximum or peak amplitude over a duration, or an average amplitude over a duration. In some embodiments, one or more of the following distinguishing features of the non-flow portion 102 may be less than the threshold: another characteristic frequency, another characteristic amplitude, and another characteristic sound energy. In some embodiments, amplitudes or frequencies unrelated to fluid flow, such as human voices or alarms, may be filtered out.

[0073] In some embodiments, in response to the sound sensor detecting one or more of the following, it may be determined that fluid is flowing through the extension tube: a specific frequency greater than a specific threshold, a specific amplitude greater than a specific threshold, or a specific sound energy greater than a specific threshold. In some embodiments, the specific frequency may include a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a duration, or an average frequency over a duration. In some embodiments, the specific amplitude may include a maximum amplitude, multiple occurrences of the maximum or peak amplitude over a duration, or an average amplitude over a duration. In some embodiments, the specific sound energy may be based on the sum of the potential and kinetic energy densities integrated over a volume of interest.

[0074] In some embodiments, in response to a sound sensor detecting one or more of the following, it may be determined that fluid is not flowing through the extension tube: a specific frequency less than a specific threshold, a specific amplitude less than a specific threshold, or a specific sound energy less than a specific threshold. In some embodiments, the specific frequency may include a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a duration, or an average frequency over a duration. In some embodiments, the specific amplitude may include a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a duration, or an average amplitude over a duration.

[0075] As Figure 5A shown, in some embodiments, the maximum amplitude in the non-flow portion 102 may be between approximately -18 dB and approximately -24 dB, which may be used as a threshold. In these and other embodiments, the maximum amplitude of the flow portion 100 may be higher, such as approximately 0 dB, approximately -2 dB, or approximately -5 dB, which may be used as a threshold. In some embodiments, the flow portion 100 may correspond to a frequency between approximately 80 Hz and approximately 200 Hz, which may be used as a threshold. In some embodiments, the non-flow portion 102 may correspond to a frequency between approximately 40 Hz and approximately 80 Hz, which may be used as a threshold. In some embodiments, Figure 5A - 5B the waveform 98 may correspond to a standard plastic extension tube (such as the extension tube of the NEXIVA™ Closed IV Catheter System from BD, USA or a similar catheter system), where the sound sensor is placed proximal to or adjacent to the extension tube. It should be understood that various scales may be used, including seconds, milliseconds, microseconds, or another unit of time on the x-axis, and decibels or another unit on the y-axis.

[0076] Now referring to Figure 5B , an exemplary waveform 104 generated by a first sound sensor and an exemplary waveform 106 generated by a second sound sensor are shown according to some embodiments. In some embodiments, the first sound sensor may be disposed distal or proximal to the second sound sensor.

[0077] In some embodiments, the direction of fluid flow within the extension tube (such as the extension tube 34 described with reference to FIGS. 1 and 2) is determined in response to the first sound sensor detecting fluid flow through the extension tube before or after another sound sensor detects fluid flow through the extension tube. As Figure 5B shown, for example, as indicated by the flow portion 100 of waveform 104 occurring earlier in time than the flow portion 100 of waveform 106, the first sound sensor may detect fluid flow through the extension tube before the second sound sensor detects fluid flow through the extension tube. In some embodiments, the flow portion 100 of waveform 104 may be separated from the flow portion 100 of waveform 106 by a time delay 108.

[0078] In some embodiments, in response to the first sound sensor being disposed distally of the second sound sensor, Figure 5B the time delay 108 shown in FIG. may indicate that fluid is flowing through the extension tube in the proximal direction. In some embodiments, in response to the first sound sensor being disposed proximally of the second sound sensor, Figure 5B the time delay 108 shown in FIG. may indicate that fluid is flowing through the extension tube in the distal direction.

[0079] Likewise, it should be understood that various scales may be used, including seconds, milliseconds, microseconds or another unit of time on the x-axis, and decibels or another unit on the y-axis. In some embodiments, the time delay 108 may be less than one or more milliseconds or less than one or more microseconds. In some embodiments, the time delay 108 may be based on the distance between the first sound sensor and the second sound sensor, and this distance may vary. In some embodiments, the first sound sensor and / or the second sound sensor may detect the distance or time delay between one or more peaks of the waveforms 104 and 106, which may indicate that fluid is flowing through the extension tube in a particular direction. For example, if the first sound sensor detects one or more peaks before the second sound sensor, it may be determined that the fluid is flowing in the proximal direction.

[0080] All of the examples and conditional language recited herein are intended for pedagogical purposes to aid the reader in understanding the invention and the concepts contributed by the inventor to the art, and are to be construed as not being limited to such specifically recited examples and conditions. Although the embodiments of the invention have been described in detail, it should be understood that various modifications, substitutions and alterations can be made thereto without departing from the spirit and scope of the invention.

Claims

1. A catheter assembly, comprising: a catheter adapter; an extension tube coupled to the catheter adapter; and a pinch-type clamp disposed on the extension tube and configured to pinch the extension tube in response to the clamp moving to a closed position, wherein the clamp comprises: arms including protrusions that contact and pinch the extension tube; a clamping surface; a first sound sensor and a second sound sensor embedded in the clamping surface, wherein the first sound sensor is distal to the second sound sensor; a light; and a computing system configured to: detect, via the first sound sensor and the second sound sensor, that fluid is not flowing through the extension tube; initiate a timer in response to detecting, via the first sound sensor and the second sound sensor, that fluid is not flowing through the extension tube; provide an alarm in response to the timer reaching a predetermined duration, the alarm including a visual indication provided by the light; detect, via the first sound sensor and the second sound sensor, that fluid is flowing through the extension tube; and stop and / or reset the timer and stop the light from providing the indication in response to the second sound sensor detecting that fluid is flowing through the extension tube.

2. The catheter assembly according to claim 1, wherein the light is embedded in the arm.

3. The catheter assembly according to claim 1, wherein the computing system includes a processor, a memory, a data storage device, and a communication unit, the data storage device including a flushing module configured to monitor fluid flowing through the catheter assembly.

4. The catheter assembly according to claim 1, wherein the predetermined duration corresponds to a clinically recommended time for flushing the catheter assembly, the clamp provides a first alarm in response to the clinically recommended time for flushing the catheter assembly approaching, and the clamp provides a second alarm in response to the clinically recommended time for flushing the catheter assembly having arrived.

5. The catheter assembly according to claim 4, wherein the first alarm and the second alarm are different colors.

6. The catheter assembly according to claim 1, wherein the computing system detects fluid flowing in a distal direction in the extension tube by determining, based on signals received from the first sound sensor and the second sound sensor, that the second sound sensor generates a signal indicating fluid flow before the first sound sensor generates a signal indicating fluid flow.

7. The catheter assembly according to claim 6, wherein the computing system identifies a signal indicating fluid flow by determining that the amplitude of the corresponding signal is greater than a threshold.

8. The catheter assembly according to claim 7, wherein the amplitude is an average amplitude.

9. The catheter assembly according to claim 7, wherein the threshold is based on the thickness of the extension tube.

10. The catheter assembly according to claim 1, wherein the first sound sensor and the second sound sensor contact the extension tube.

11. An extension kit for a catheter assembly, comprising: an extension tube; a pinch-type clamp disposed on the extension tube and configured to pinch the extension tube in response to the clamp moving to a closed position, wherein the clamp comprises: arms including protrusions that contact and pinch the extension tube; a clamping surface; a first sound sensor and a second sound sensor embedded in the clamping surface, wherein the first sound sensor is distal to the second sound sensor; a light; and a computing system configured to: detect, via the first sound sensor and the second sound sensor, that fluid is not flowing through the extension tube; initiate a timer in response to detecting, via the first sound sensor and the second sound sensor, that fluid is not flowing through the extension tube; provide an alarm in response to the timer reaching a predetermined duration, the alarm including a visual indication provided by the light; detect, via the first sound sensor and the second sound sensor, that fluid is flowing through the extension tube; and stop and / or reset the timer and stop causing the light to provide the indication in response to the second sound sensor detecting that fluid is flowing through the extension tube.

12. The extension kit according to claim 11, wherein the light is embedded in the arm.

13. The extension kit according to claim 11, wherein the computing system includes a processor, a memory, a data storage device, and a communication unit, the data storage device including a flushing module configured to monitor fluid flowing through the catheter assembly.

14. The extension kit according to claim 13, wherein the predetermined duration corresponds to a clinically recommended time for flushing the catheter assembly, the clamp provides a first alarm in response to the clinically recommended time for flushing the catheter assembly approaching, and the clamp provides a second alarm in response to the clinically recommended time for flushing the catheter assembly having arrived.

15. The extension kit according to claim 14, wherein the first alarm and the second alarm are different colors.

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