Patent Description:
A common type of catheter is an over-the-needle peripheral IV catheter ("PIVC"), a peripherally inserted central catheter ("PICC"), or a midline catheter. As its name implies, the over-the-needle catheter may be mounted over an introducer needle having a sharp distal tip. The sharp distal tip may be used to pierce skin and the vasculature of the patient. Insertion of the catheter into the vasculature may follow the piercing of the vasculature by the needle. The needle and the catheter are generally inserted at a shallow angle through the skin into the vasculature of the patient with a bevel of the needle facing away from the skin of the patient. Once placement of the needle within the vasculature has been confirmed, the clinician may temporarily occlude flow in the vasculature and withdraw the needle, leaving the catheter in place for future blood withdrawal and/or fluid infusion.

In some instances, the catheter may become unusable or compromised be due to occlusion of the catheter over time. In response to the catheter becoming occluded, the catheter may need to be removed and replaced with a new catheter. Catheter occlusions may be thrombotic, resulting from formation of a thrombus within or surrounding a distal tip of the catheter. Catheter occlusions may also be non-thrombotic, resulting from precipitates, mechanical obstructions, and other factors. Further, catheter occlusions can lead to catheter infection, pulmonary embolism, post-thrombotic syndrome, and other negative health outcomes. post-thrombotic syndrome, and other negative health outcomes. Clinicians may regularly flush the catheter to prevent occlusion and extend an indwelling period of the catheter.

<CIT> discloses a disposable cartridge for producing gas-enriched fluids.

<CIT> discloses an intelligent management system for transfusion.

<CIT> discloses a clip-based vascular closure device to be pre-applied to a blood vessel prior to insertion of a vascular access device.

The present disclosure relates generally to vascular access systems and related devices and methods. According to the invention, a method to monitor fluid flow through a catheter assembly includes providing a clamp for an extension tube of the catheter assembly. According to the invention, the clamp includes an acoustic sensor, which is configured to detect the clamp is open or fluid is flowing through the extension tube of the catheter assembly. The acoustic sensor is configured to detect the clamp is closed or fluid is not flowing through the extension tube of the catheter assembly.

In some embodiments, the method may include starting a timer in response to the acoustic sensor detecting the clamp is closed. In some embodiments, the method may include providing an alert in response to the timer reaching a predetermined duration of time. In some embodiments, the alert may indicate to a clinician that the catheter assembly should be opened and flushed, which may prevent occlusion of the catheter assembly.

In some embodiments, providing the alert may include transmitting an alert signal over a network to a monitoring device, such as a clinician monitoring device. In some embodiments, the alert signal may indicate to the monitoring device to provide the alert. In some embodiments, embodiments, the alert may include a sound, a tactile vibration, or a visual cue. In some embodiments, the visual cue may include a change in status of a light. In some embodiments, an indication may be provided in an electronic health record of a patient in response to the acoustic sensor detecting the clamp is closed.

In some embodiments, the acoustic sensor may be configured to detect the clamp is open. In some embodiments, in response to the acoustic sensor detecting the clamp is open for another predetermined duration of time, the timer may be stopped and/or reset. In some embodiments, in response to the acoustic sensor detecting the clamp is open for the other predetermined duration of time, another alert signal may be transmitted over the network to the monitoring device to stop the alert or provide another alert. In some embodiments, another indication may be provided in the electronic health record of the patient in response to the acoustic sensor detecting the clamp is open for the other predetermined duration of time.

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 disposed distal to the other acoustic sensor. In some embodiments, a fluid flow direction within the extension tube may be determined in response to the acoustic sensor detecting fluid flowing through the extension tube prior to or after the other acoustic sensor detecting fluid flowing through the extension tube. In some embodiments, in response to the other acoustic sensor detecting the clamp is open and fluid is flowing through the extension tube of the catheter assembly, the timer may be stopped and/or reset.

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 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.

Referring now to <FIG>, an example catheter system <NUM> is illustrated, according to some embodiments. In some embodiments, the catheter system <NUM> may include a catheter assembly <NUM>. In some embodiments, the catheter assembly <NUM> may include a catheter adapter <NUM> and a catheter <NUM> extending distally from the catheter adapter <NUM>. In some embodiments, the catheter adapter <NUM> may include a side port <NUM> in fluid communication with the lumen of the catheter adapter <NUM>. In some embodiments, the catheter adapter <NUM> may include a proximal end <NUM>, a distal end <NUM>, and a lumen extending there between. In some embodiments, the catheter <NUM> may include a PIVC.

In some embodiments, the catheter assembly <NUM> may be removably coupled to a needle assembly, which may include a needle hub <NUM> and an introducer needle <NUM>. In some embodiments, the introducer needle <NUM> may include a sharp distal tip <NUM>. In some embodiments, a proximal end of the introducer needle <NUM> may be secured within the needle hub <NUM>.

In some embodiments, the introducer needle <NUM> may extend through the catheter <NUM> when the catheter assembly <NUM> is in an insertion position ready for insertion into vasculature of a patient, as illustrated, for example, in <FIG>. In some embodiments, in response to the introducer needle <NUM> being inserted into the vasculature of the patient, flashback of blood may flow through the sharp distal tip <NUM> of the introducer needle <NUM> and may be visible to a clinician between the introducer needle <NUM> and the catheter <NUM> and/or at another location within the catheter assembly <NUM>.

In some embodiments, in response to confirmation via the blood flashback that the catheter <NUM> is positioned within vasculature of the patient, the needle assembly may be removed from the catheter assembly <NUM>. In some embodiments, when the needle assembly is coupled to the catheter assembly <NUM>, as illustrated, for example, in <FIG>, the introducer needle <NUM> of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter <NUM>.

In some embodiments, the catheter system <NUM> may include a catheter line <NUM>, which may include an extension tube <NUM> and a clamp <NUM> through which the extension tube <NUM> may extend. In some embodiments, a distal end of the extension tube <NUM> may be integrated with the catheter adapter <NUM>, as illustrated, for example, in <FIG>. For example, the extension tube <NUM> may be integrated with the side port <NUM> of the catheter adapter <NUM>. In some embodiments, the extension tube <NUM> may be removably coupled to the catheter adapter <NUM>. In some embodiments, the clamp <NUM> may selectively close off the extension tube <NUM> to prevent blood or another fluid from flowing through the extension tube <NUM>.

In some embodiments, an adapter <NUM> may be coupled to a proximal end of the extension tube <NUM>. In some embodiments, the adapter <NUM> may include a Y-adapter or another suitable connector. In some embodiments, a needleless connector <NUM> may be coupled to the adapter <NUM>. In some embodiments, the adapter <NUM> and/or the needleless connector <NUM> may be used to connect the catheter <NUM> with a medical device for fluid administration or blood withdrawal. The medical device may include a transfusion bag, syringe, or any other suitable medical device.

In some embodiments, the catheter system <NUM> may include any suitable catheter assembly <NUM> and the clamp <NUM> may be coupled to any suitable extension tube. In some embodiments, the extension tube <NUM> may extend from the proximal end <NUM> of the catheter adapter <NUM>. In some embodiments, the clamp <NUM> may be disposed on an IV line, which may extend between an IV bag and the catheter assembly <NUM>. In some embodiments, the catheter assembly <NUM> may include a PIVC, a PICC, or a midline catheter. In some embodiments, a peripherally inserted central catheter ("PICC") assembly may include pigtail extension tubes, and a particular clamp <NUM> may be coupled to one or more of the pigtail extension tubes.

In some embodiments, an extension set may be configured to directly or indirectly couple to the catheter assembly <NUM>. In some embodiments, the extension set may include the IV line, the extension tube <NUM>, or any other extension tube in fluid communication with the catheter assembly <NUM>. In some embodiments, the extension set may include the clamp <NUM>.

Referring now to <FIG>, in response to the clamp <NUM> being opened, fluid may flow through the extension tube <NUM> and the catheter assembly <NUM>. For example, fluid may be infused into the patient via a medical device coupled to the adapter <NUM> or blood may be withdrawn from the patient into a blood collection device coupled to the adapter <NUM>. In some embodiments, the clamp <NUM> may include a first acoustic sensor 42a and/or a second acoustic sensor 42b (which may be collectively referred to in the present disclosure as "acoustic sensors <NUM>"). In some embodiments, each of the acoustic sensors <NUM> may be configured to detect fluid is flowing through the extension tube <NUM> or the clamp <NUM> is open. In some embodiments, each of the acoustic sensors <NUM> may be configured to detect fluid is not flowing through the extension tube <NUM> or the clamp <NUM> is closed. In some embodiments, the first acoustic sensor 42a and/or the second acoustic sensor 42b may include one or more microphones.

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 <NUM> and the clamp <NUM> is open or closed. In some embodiments, the first acoustic sensor 42a may be disposed distal to the second acoustic sensor 42b. In some embodiments, a fluid flow direction within the extension tube <NUM> may be determined in response to the first acoustic sensor 42a detecting fluid flowing through the extension tube <NUM> prior to or after the other acoustic sensor 42b detecting fluid flowing through the extension tube <NUM>. In some embodiments, the fluid flow direction may be determined to be proximal in response to the first acoustic sensor 42a detecting fluid flowing through the extension tube <NUM> prior to the second acoustic sensor 42b detecting fluid flowing through the extension tube <NUM>. In some embodiments, the fluid flow direction may be determined to be distal in response to the second acoustic sensor 42b detecting fluid flowing through the extension tube <NUM> prior to the first acoustic sensor 42a.

In some embodiments, the acoustic sensors <NUM> may be electrically coupled to a circuit board <NUM> and a battery <NUM>. In some embodiments, a location of the circuit board <NUM> and the battery <NUM> may vary. In some embodiments, the circuit board <NUM> may include a communication unit.

Referring now to <FIG>, in response to the clamp <NUM> being closed, fluid may be prevented from flowing through the extension tube <NUM>. In some embodiments, in response to the clamp <NUM> being closed, substantially all fluid may be prevented from flow through the extension tube <NUM>. In some embodiments, the clamp <NUM> may include a pinch clamp, which may pinch the extension tube <NUM> in response to movement of the clamp <NUM> to the closed position.

In some embodiments, the clamp <NUM> may include any clamp that is coupled with an extension tube, such as, for example, the extension tube <NUM>. In some embodiments, an example clamp <NUM> is described in <CIT>, entitled "PINCH CLAMP DEVICE,". In some embodiments, the extension tube <NUM> may extend through the clamp <NUM>. In some embodiments, the clamp <NUM> may include an arm <NUM>, which may include a protrusion that contacts and pinches the extension tube <NUM>. In some embodiments, the clamp <NUM> may include any suitable clamp, and the acoustic sensors <NUM> may include any suitable acoustic sensors. In some embodiments, the acoustic sensors <NUM> may be disposed at various locations.

In some embodiments, the acoustic sensors <NUM> may be embedded in the clamp <NUM>. In these and other embodiments, one or more of the acoustic sensors <NUM> may contact the extension tubing <NUM>. In some embodiments, one or more of the acoustic sensors <NUM> may be spaced apart from the extension tubing <NUM>. In some embodiments, the first acoustic sensor 42a may be disposed distal to the second acoustic sensor 42b.

In some embodiments, a position of the acoustic sensors <NUM> may vary. In some embodiments, the acoustic sensors <NUM> may be disposed on a clamping surface of the clamp <NUM> that contacts the extension tube <NUM> when the clamp <NUM> is in an open position and/or a closed position. In some embodiments, the clamping surface may be generally planar or curved. In some embodiments, the acoustic sensors <NUM> may be disposed on a non-clamping surface. In some embodiments, the acoustic sensors <NUM> may be disposed on opposite sides of the extension tube <NUM>. In some embodiments, the acoustic sensors <NUM> may be disposed on a same side of the extension tube <NUM>.

In some embodiments, the clamp <NUM> may provide an alert which may include a sound, a tactile vibration, or a visual cue. In some embodiments, the visual cue may include a change in status of a light. <FIG> illustrate an example light <NUM>, according to some embodiments. In some embodiments, the status of the light <NUM> may change in response to the clamp <NUM> being closed for a predetermined duration of time. For example, the light <NUM> may turn on or may change color in response to the clamp <NUM> being closed for the predetermined duration of time. As another example, the light <NUM> may blink or change a rate of blinking in response to the clamp <NUM> being closed for the predetermined duration of time.

In some embodiments, the predetermined duration of time may correspond to a time prior to a clinically recommended time to flush the catheter assembly <NUM>. In these embodiments, the alert may include a warning, which may indicate to the clinician that a clinically recommended time to flush the catheter assembly <NUM> is approaching. In some embodiments, the clinically recommended time to flush the catheter assembly <NUM> may be between about <NUM> hours and about <NUM> hours from the previous flushing of the catheter assembly <NUM>.

In some embodiments, the predetermined duration of time may correspond to the clinically recommended time to flush the catheter assembly <NUM>. In some embodiments, a first alert may be provided by the clamp <NUM> in response to the clinically recommended time to flush the catheter assembly <NUM> approaching (such as, for example, in <NUM> minutes, <NUM> minutes, or <NUM> minutes), and a second alert may be provided by the clamp <NUM> in response to arrival of the clinically recommended time to flush the catheter assembly <NUM>. In some embodiments, the first alert may include a yellow or orange light, and the second alert may include a red light.

In some embodiments, the light <NUM> may be disposed at various locations on the clamp <NUM>, which may be visible to the clinician. In some embodiments, the clamp <NUM> may include multiple lights <NUM>. In some embodiments, a size of the light <NUM> may vary.

Referring now to <FIG>, an example clinician monitoring device <NUM> is illustrated, according to some embodiments. Examples of the clinician monitoring device <NUM> may 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 (e.g., a smartwatch, smart glasses, or any other connected device). In some embodiments, in addition to the clamp <NUM> or as an alternative to the clamp <NUM>, the clinician monitoring device <NUM> may provide the alert.

In some embodiments, the clinician monitoring device <NUM> may include a display screen <NUM>, which may provide the 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 <NUM>, such as a portion of the display screen <NUM> that lights up or changes color. In some embodiments, the portion of the display screen <NUM> may blink or change a rate of blinking to provide the alert. In some embodiments, the clinician monitoring device <NUM> may include the light <NUM>, as described, for example, with respect to <FIG>.

Referring now to <FIG>, an example electronic health record <NUM> that may be presented on the display screen <NUM> of the clinician monitoring device <NUM> is illustrated, according to some embodiments. In some embodiments, an indication may be provided on the display screen <NUM> in response to opening and/or closing of the clamp <NUM>. In some embodiments, the indication may be provided on the display screen <NUM> in response to opening the clamp <NUM> for a particular predetermined duration of time and/or closing the clamp <NUM> for a particular predetermined duration of time.

In some embodiments, the indication may include one or more of the following: a time of day <NUM>, a status <NUM>, and a duration of time <NUM>. In some embodiments, the duration of time <NUM> may include a duration of time the clamp <NUM> has been closed. In some embodiments, the status <NUM> may include "open" and may be adjacent to the time of day <NUM>, indicating to the clinician the time of day at which the clamp <NUM> was opened. In some embodiments, the status <NUM> may include "closed" and may be adjacent to the time of day <NUM>, indicating to the clinician the time of day at which the clamp <NUM> was closed.

<FIG> is as block diagram of an example flush management system (FM system) <NUM>, arranged in accordance with at least one embodiment described in the present disclosure. In some embodiments, the FM system <NUM> may include the clamp <NUM>. In some embodiments, the clamp <NUM> may include or correspond to the clamp <NUM> described with respect to <FIG> or the clamp <NUM> described with respect to <FIG>. In some embodiments, the clamp <NUM> may include a computing system <NUM>.

In some embodiments, the computing system <NUM> may include a processor <NUM>, a memory <NUM>, a data storage <NUM>, and a communication unit <NUM>. In some embodiments, the processor <NUM>, the memory <NUM>, the data storage <NUM>, and the communication unit <NUM> may be communicatively coupled by a bus <NUM>. The bus <NUM> 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 <NUM> may include a timer <NUM>. In some embodiments, the timer <NUM> may be a separate component linked to the processor <NUM>.

In general, the processor <NUM> may include any suitable special-purpose 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 media. For example, the processor <NUM> 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 circuitry configured to interpret and/or to execute program instructions and/or to process data. Although illustrated as a single processor in <FIG>, the processor <NUM> may include any number of processors configured to perform, individually or collectively, any number of operations described in the present disclosure. Additionally, one or more of the processors <NUM> may be present on one or more different electronic devices.

In some embodiments, the processor <NUM> may interpret and/or execute program instructions and/or process data stored in the memory <NUM>, the data storage <NUM>, or the memory <NUM> and the data storage <NUM>. In some embodiments, the processor <NUM> may fetch program instructions from the data storage <NUM> and load the program instructions in the memory <NUM>. In some embodiments, after the program instructions are loaded into memory <NUM>, the processor <NUM> may execute the program instructions.

For example, in some embodiments, a flush module <NUM> may be included in the data storage <NUM> as program instructions. In some embodiments, the flush module <NUM> may be configured to manage flushing of the catheter line <NUM> and the catheter assembly <NUM>. In some embodiments, the flush module <NUM> may be configured to monitor fluid flow through the catheter assembly <NUM>. The processor <NUM> may fetch the program instructions of the flush module <NUM> from the data storage <NUM> and may load the program instructions of the flush module <NUM> in the memory <NUM>. After the program instructions of the flush module <NUM> are loaded into the memory <NUM>, the processor <NUM> may execute the program instructions such that the computing system <NUM> may implement the operations associated with the flush module <NUM> as directed by the instructions.

The memory <NUM> and the data storage <NUM> may include computer-readable storage media for carrying or having computer-executable instructions or data structures stored thereon. Such computer-readable storage media may include any available media that may be accessed by a general-purpose or special-purpose computer, such as the processor <NUM>. 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 memory devices), or any other storage medium which may be used to carry or store desired program code in the form of computer-executable instructions or data structures and which may be accessed by a general-purpose or special-purpose computer. Combinations of the above may also be included within the scope of computer-readable storage media. Computer-executable instructions may include, for example, instructions and data configured to cause the processor <NUM> to perform a certain operation or group of operations.

In some embodiments, one or more clinician monitoring devices <NUM> may be connected to the computing system <NUM> via a network <NUM>. In these and other embodiments, the network <NUM> may include a wired or wireless network, and may have any suitable configuration, such as a star configuration, a token ring configuration, or other configurations. Furthermore, in some embodiments, the network <NUM> 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 across which multiple devices may communicate. In some embodiments, the network <NUM> may include a peer-to-peer network. In some embodiments, the network <NUM> may also be coupled to or include portions of a telecommunications network that may enable communication of data in a variety of different communication protocols. In some embodiments, the clinician monitoring devices <NUM> may include or correspond to any of the clinician monitoring devices <NUM> described with respect to <FIG>.

In some embodiments, the network <NUM> may include BLUETOOTH® communication networks and/or cellular communications networks for sending and receiving data including via short messaging service (SMS), multimedia messaging service (MMS), hypertext transfer protocol (HTTP), direct data connection, wireless application protocol (WAP), e-mail, etc. The network <NUM> may enable communication via a standard-based protocol such as smart energy profile (SEP), Echonet Lite, OpenADR, or another suitable protocol (e.g., wireless fidelity (Wi-Fi), ZigBee, HomePlug Green, etc.).

In some embodiments, the communication unit <NUM> may be configured to transmit data to and receive data from the clinician monitoring devices <NUM> via the network <NUM>. In some embodiments, the communication unit <NUM> may also be configured to transmit and receive data from a display screen <NUM> and/or an electronic health record <NUM>. In some embodiments, the display screen <NUM> may include or correspond to the display screen <NUM> described with respect to <FIG>. In some embodiments, the electronic health record <NUM> may include or correspond to the electronic health record <NUM> of <FIG>. In some embodiments, the flush module <NUM> may be configured to send and receive data via the communication unit <NUM>.

In some embodiments, the communication unit <NUM> may include a port for direct physical connection to the network <NUM> and/or another communication channel. For example, the communication unit <NUM> may include a universal serial bus (USB) port, a secure digital (SD) port, a category <NUM> cable (CAT-<NUM>) port, or similar port for wired communication with another device. In some embodiments, the communication unit <NUM> may include a wireless transceiver for exchanging data with the clinician monitoring device <NUM> or other communication channels using one or more wireless communication methods, including IEEE <NUM>, IEEE <NUM>, BLUETOOTH®, or another suitable wireless communication method.

In some embodiments, the communication unit <NUM> may include a cellular communications transceiver for sending and receiving data over a cellular communications network including via SMS, MMS, HTTP, direct data connection, WAP, e-mail, or another suitable type of electronic communication. The communication unit <NUM> may also provide other conventional connections to the network <NUM> for distribution of files or media objects using standard network protocols including transmission control protocol/internet protocol (TCP/IP), HTTP, HTTP secure (HTTPS), and simple mail transfer protocol (SMTP).

An example of how the flush module <NUM> may manage flushing of a catheter assembly or monitor fluid flow through the catheter assembly is now provided. In some embodiments, in response to one or more acoustic sensors <NUM> detecting the clamp is closed, the flush module <NUM> may be configured to start a timer <NUM>. In some embodiments, the acoustic sensors <NUM> may include or correspond to the acoustic sensors <NUM> described with respect to <FIG> or <FIG>. In some embodiments, in response to the timer <NUM> reaching a predetermined duration of time, the flush module <NUM> may be configured to generate one or more alerts at the clamp and/or to transmit an alert signal over the network <NUM> to the clinician monitoring devices <NUM>, which may provide one or more alerts. In some embodiments, the alerts may include any of the alerts described with respect to <FIG> and <FIG>. In some embodiments, the alerts may indicate to the clinician that the clinically recommended time to flush the catheter assembly has arrived or is approaching.

In some embodiments, the flush module <NUM> may be configured to provide an indication in an electronic health record <NUM> of a patient in response to the acoustic sensors <NUM> detecting the clamp <NUM> is closed. In some embodiments, the electronic health record <NUM> may be stored and/or displayed on the clinician monitoring devices <NUM>. In some embodiments, the electronic health record <NUM> may include or correspond to the electronic health record <NUM> described with respect to <FIG>.

In some embodiments, in response to the acoustic sensors <NUM> detecting the clamp <NUM> is open or open for another predetermined duration of time, the flush module <NUM> may be configured to stop and/or reset the timer <NUM>. In some embodiments, the flush module <NUM> may be configured to stop the timer <NUM> only after the clamp <NUM> has been open for the other predetermined duration of time to prevent opening of the clamp <NUM> when adequate flushing could not have occurred.

In some embodiments, in response to the acoustic sensors <NUM> detecting the clamp is open for the other predetermined duration, the flush module <NUM> may be configured to stop the alert at the clamp <NUM> or provide a different alert at the clamp. Additionally or alternatively, in some embodiments, in response to the acoustic sensors <NUM> detecting the clamp is open for the other predetermined duration, the flush module <NUM> may be configured to transmit another alert signal over the network <NUM> to the clinician monitoring devices <NUM> to stop the alert or provide a different alert. In some embodiments, the flush module <NUM> may be configured to provide another indication in the electronic health record <NUM> of the patient in response to the acoustic sensor <NUM> detecting the clamp <NUM> is open for the other predetermined duration of time.

In some embodiments, in response to one or more of the acoustic sensors <NUM> detecting fluid flowing through the extension tube of the catheter assembly, the flush module <NUM> may be configured to stop and/or reset the timer <NUM>. In some embodiments, an external server may include one or more components of the computing system <NUM>. For example, the external server may include the processor <NUM>. In some embodiments, the external server may be connected to the clamp <NUM> and/or the clinician monitoring device <NUM> via the network <NUM> or another network. Modifications, additions, or omissions may be made to the FM system <NUM> without departing from the scope of the present disclosure.

Referring now to <FIG>, a clamp <NUM> is illustrated, according to some embodiments. In some embodiments, the clamp <NUM> may include or correspond to the clamp <NUM> described with respect to <FIG>. In some embodiments, the clamp <NUM> may replace the clamp <NUM> in <FIG>. In some embodiments, the extension tube <NUM> of the catheter system <NUM> of <FIG> may extend through the clamp <NUM>.

In some embodiments, the clamp <NUM> may not include a pinch clamp. In some embodiments, the clamp <NUM> may not be configured to pinch the extension tube <NUM> or stop fluid flow through the extension tube <NUM>. In some embodiments, when the clamp <NUM> is disposed in a closed position, the clamp <NUM> may surround the extension tube <NUM>.

In some embodiments, the extension tube <NUM> may include the clamp <NUM> and/or a pinch clamp. In some embodiments, the clamp <NUM> may be coupled to any suitable extension tube. In some embodiments, the clamp <NUM> may be disposed on an IV line, which may extend between an IV bag and the catheter assembly <NUM>. In some embodiments, a peripherally inserted central catheter ("PICC") assembly may include pigtail extension tubes, and a particular clamp <NUM> may be coupled to one or more of the pigtail extension tubes.

In some embodiments, the clamp <NUM> may open via one or more hinges <NUM> or another suitable mechanism. In some embodiments, the clamp <NUM> may include a channel <NUM> extending there through. In some embodiments, an outer diameter of the extension tube <NUM> may be slightly less than a diameter of the channel <NUM>. In some embodiments, the extension tube <NUM> may contact the channel <NUM>.

In some embodiments, a position of the acoustic sensors <NUM> may vary. In some embodiments, the acoustic sensors <NUM> may be embedded in the channel <NUM>. In some embodiments, the acoustic sensors <NUM> may contact the extension tube <NUM> when the clamp <NUM> is in the closed position, illustrated, for example, in <FIG>. In some embodiments, the acoustic sensors <NUM> may be spaced apart from the extension tube <NUM> when the clamp <NUM> is in the closed position.

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 <NUM> and the clamp <NUM> is open or closed. In some embodiments, the first acoustic sensor 42a may be disposed distal to the second acoustic sensor 42b. In some embodiments, a fluid flow direction within the extension tube <NUM> may be determined in response to the first acoustic sensor 42a detecting fluid flowing through the extension tube <NUM> prior to or after the other acoustic sensor 42b detecting fluid flowing through the extension tube <NUM>. In some embodiments, the fluid flow direction may be determined to be proximal in response to the first acoustic sensor 42a detecting fluid flowing through the extension tube <NUM> prior to the second acoustic sensor 42b. In some embodiments, the fluid flow direction may be determined to be distal in response to the second acoustic sensor 42b detecting fluid flowing through the extension tube <NUM> prior to the first acoustic sensor 42a.

Referring now to <FIG>, an example waveform <NUM> generated by an acoustic sensor is illustrated, according to some embodiments. In some embodiments, a flow portion <NUM> of the waveform <NUM> may indicate a fluid flowing through an extension tube, such as, for example, the extension tube <NUM> described with respect to <FIG> and <FIG>. In some embodiments, a non-flow portion <NUM> of the waveform <NUM> may indicate fluid is not flowing through the extension tube <NUM> or a clamp is closed.

In some embodiments, fluid flow through the extension tube may be determined based on presence of the flow portion <NUM>, which may have a distinct signature, including one or more of the following: a characteristic frequency, a characteristic amplitude, duration, and a characteristic sound energy. In further detail, in some embodiments, the distinct signature of the flow portion <NUM> may include a characteristic frequency, such as, for example, a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a duration of time, or an average frequency over a duration of time. Additionally or alternatively, in some embodiments, the distinct signature of the flow portion <NUM> may include a characteristic amplitude, such as, for example, a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a duration of time, or an average amplitude over a duration of time. In some embodiments, one or more of the following of the distinct signature of the flow portion <NUM> may be greater or equal to one or more threshold values: the characteristic frequency, the characteristic amplitude, and the characteristic sound energy. In some embodiments, amplitudes or frequencies unrelated to fluid flow, such as, for example, human speaking or alerts, may be filtered out.

In some embodiments, the threshold values may be dependent on one or more of the following: a thickness of a wall of the extension tube, a distance of the acoustic sensor from the extension tube, a material from which the extension tube is constructed, and a gauge size of the extension tube and a catheter, such as, for example the catheter <NUM> described with respect to <FIG>. In further detail, in some embodiments, the threshold values may vary based on properties of the extension tube, such as, for example, the thickness of the wall of the extension tube, the material from which the extension tube is constructed, the gauge size of the extension tube, etc. In some embodiments, the threshold values may be measured prior to insertion of the catheter into the patient by infusing fluid through the catheter such that fluid flows through the extension tube of the catheter system and is detected by the acoustic sensor.

In some embodiments, lack of fluid flow through the extension tube may be determined based on presence of the non-flow portion <NUM>, which may have a distinct signature, including one or more of the following: another characteristic frequency, another characteristic amplitude, duration, and another characteristic sound energy. In further detail, in some embodiments, the distinct signature of the non-flow portion <NUM> may include the other characteristic frequency, such as, for example, a maximum frequency, multiple occurrences of the maximum frequency over a duration of time, or an average frequency over a duration of time. Additionally or alternatively, in some embodiments, the distinct signature of the non-flow portion <NUM> may include the other characteristic amplitude, such as, for example, a maximum amplitude, multiple occurrences of the maximum amplitude over a duration of time, or an average amplitude over a duration of time. In some embodiments, one or more of the following of the distinct signature of the non-flow portion <NUM> may be less than the threshold values: the other characteristic frequency, the other characteristic amplitude, and the other characteristic sound energy. In some embodiments, amplitudes or frequencies unrelated to fluid flow, such as, for example, human speaking or alerts, may be filtered out.

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

In some embodiments, in response to the acoustic sensor detecting one or more of the following, it may be determined fluid is not flowing through the extension tube: 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 value. In some embodiments, the particular frequency may include a maximum or peak frequency, multiple occurrences of the maximum or peak frequency over a duration of time, or an average frequency over a duration of time. In some embodiments, the particular amplitude may include a maximum or peak amplitude, multiple occurrences of the maximum or peak amplitude over a duration of time, or an average amplitude over a duration of time.

As illustrated in <FIG>, in some embodiments, the maximum amplitude in the non-flow portion <NUM> may be between about -<NUM> dB and about -<NUM> dB, which may be used as threshold value. In these and other embodiments, the maximum amplitude the flow portion <NUM> may be higher, such as, for example, about <NUM> dB, about -<NUM> dB, or about -<NUM> dB, which may be used as threshold values. In some embodiments, the flow portion <NUM> may correspond to a frequency between about <NUM> and about <NUM>, which may be used as threshold values. In some embodiments, the non-flow portion <NUM> may correspond to a frequency between about <NUM> and about <NUM>, which may be used as threshold values. In some embodiments, the waveform <NUM> of <FIG> may correspond to standard plastic extension tube, such as, for example, that of the Becton Dickinson NEXIVA™ Closed IV Catheter System or a similar catheter system, with the acoustic sensor placed proximate or in close proximity to the extension tube. It is understood that various scales may be used, including seconds, milliseconds, microseconds, or another time unit on the x-axis, and decibels or another unit on the y-axis.

Referring now to <FIG>, an example waveform <NUM> generated by a first acoustic sensor and an example waveform <NUM> generated by a second acoustic sensor are illustrated, according to some embodiments. In some embodiments, the first acoustic sensor may be disposed distal or proximal to the second acoustic sensor.

In some embodiments, a fluid flow direction within an extension tube, such as, for example, the extension tube <NUM> described with respect to <FIG> and <FIG>, may be determined in response to the first acoustic sensor detecting fluid flowing through the extension tube prior to or after the other acoustic sensor detecting fluid flowing through the extension tube. As illustrated in <FIG>, for example, the first acoustic sensor may detect fluid flowing through the extension tube prior to the second acoustic sensor detecting fluid flowing through the extension tube, as indicated by the flow portion <NUM> of the waveform <NUM> occurring earlier in time than the flow portion <NUM> of the waveform <NUM>. In some embodiments, the flow portion <NUM> of the waveform <NUM> may be spaced apart from the flow portion <NUM> the waveform <NUM> by a time delay <NUM>.

In some embodiments, in response to the first acoustic sensor being disposed distal to the second acoustic sensor, the time delay <NUM> illustrated in <FIG> may indicate fluid flowing through the extension tube in a proximal direction. In some embodiments, in response to the first acoustic sensor being disposed proximal to the second acoustic sensor, the time delay <NUM> illustrated in <FIG> may indicate fluid flowing through the extension tube in a distal direction.

Again, it is understood that various scales may be used, including seconds, milliseconds, microseconds, or another time unit on the x-axis, and decibels or another unit on the y-axis. In some embodiments, the time delay <NUM> may be less than one or more milliseconds or less than one or more microseconds. In some embodiments, the time delay <NUM> may be based on a 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 of the waveform <NUM> and the waveform <NUM>, 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 prior to the second acoustic sensor detecting the one or more peaks, it may be determined that fluid is flowing in the proximal direction.

Claim 1:
A method to monitor fluid flow through a catheter assembly (<NUM>), the method comprising:
providing a clamp (<NUM>) comprising:
an open position and a closed position, wherein the open position permits a fluid to flow through an extension tube (<NUM>) positioned within the clamp, and wherein the closed position prevents a fluid from flowing through an extension tube (<NUM>) positioned within the clamp;
a clamping surface in which is embedded an acoustic sensor (<NUM>), wherein the acoustic sensor is configured to contact an extension tube (<NUM>) of a catheter assembly (<NUM>) when the clamp is in either the closed or open positions, and, to detect whether a fluid is flowing through an extension tube positioned within the clamp, wherein the clamp and the acoustic sensor are disposed outside of the extension tube; and
detecting, via the acoustic sensor, a fluid flowing through the extension tube.