Patent Publication Number: US-2023139121-A1

Title: Catheter system clamp, systems, and methods

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. application Ser. No. 16/841,379, filed Apr. 6, 2020, and entitled CATHETER SYSTEM CLAMP, SYSTEMS, AND METHODS, which claims the benefit of U.S. Application No. 62/830,838, filed Apr. 8, 2019, and entitled CATHETER SYSTEM CLAMP, SYSTEMS, AND METHODS, which are incorporated herein in their entirety. 
    
    
     BACKGROUND 
     Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition, into a patient. Catheters may also be used for withdrawing blood from the patient. 
     A common type of catheter is an over-the-needle peripheral IV catheter (“PIVC”). As its name implies, the over-the-needle PIVC 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 PIVC into the vasculature may follow the piercing of the vasculature by the needle. The needle and the PIVC 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 PIVC in place for future blood withdrawal and/or fluid infusion. 
     In some instances, the PIVC may become unusable or compromised be due to occlusion of the PIVC over time. In response to the PIVC becoming occluded, the PIVC 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. Clinicians are instructed to regularly flush the PIVC to prevent occlusion and extend an indwelling period of the PIVC but some may fail to follow flushing protocols. 
     The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. 
     SUMMARY 
     The present disclosure relates generally to vascular access systems and related devices and methods. In some embodiments, a method to manage flushing of a catheter assembly may include providing a clamp for a fluid tube configured to couple to the catheter assembly. In some embodiments, the clamp may include a sensor configured to detect when the clamp is closed. In some embodiments, the method may include starting a timer in response to the 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, 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 sensor detecting the clamp is closed. 
     In some embodiments, the sensor may be configured to detect the clamp is open. In some embodiments, in response to the 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 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 sensor detecting the clamp is open for the other predetermined duration of time. 
     In some embodiments, another sensor may be provided, which may be configured to detect fluid flowing through the fluid tube. In some embodiments, the other sensor may include a flow sensor. In some embodiments, in response to the sensor detecting the clamp is open and the other sensor detecting fluid flowing through the fluid tube, 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. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which: 
         FIG.  1 A  is an upper perspective view of an example catheter system, according to some embodiments; 
         FIG.  1 B  is an upper perspective view of an example clamp, illustrating the clamp in an open position, according to some embodiments; 
         FIG.  1 C  is an upper perspective view of the clamp of  FIG.  1 B , illustrating the clamp is a closed position, according to some embodiments; 
         FIG.  1 D  is an upper perspective view of an example clinician monitoring device, according to some embodiments; 
         FIG.  1 E  is an example electronic health record that may be presented on a display screen of a clinician monitoring device, according to some embodiments; and 
         FIG.  2    is a block diagram of an example flush management system, according to some embodiments. 
     
    
    
     DESCRIPTION OF EMBODIMENTS 
     Referring now to  FIG.  1 A , an example catheter system  14  is illustrated, according to some embodiments. In some embodiments, the catheter system  14  may include a catheter assembly  16 . In some embodiments, the catheter assembly  16  may include a catheter adapter  18  and a catheter  20  extending distally from the catheter adapter  18 . In some embodiments, the catheter adapter  18  may include a side port  22  in fluid communication with the lumen of the catheter adapter  18 . In some embodiments, the catheter adapter  18  may include a proximal end  23 , a distal end  24 , and a lumen extending there between. In some embodiments, the catheter  20  may include a PIVC. 
     In some embodiments, the catheter assembly  16  may be removably coupled to a needle assembly, which may include a needle hub  26  and an introducer needle  28 . In some embodiments, the introducer needle  28  may include a sharp distal tip  30 . In some embodiments, a proximal end of the introducer needle  28  may be secured within the needle hub  26 . In some embodiments, the introducer needle  28  may extend through the catheter  20  when the catheter assembly  16  is in an insertion position ready for insertion into vasculature of a patient, as illustrated, for example, in  FIG.  1 A . In some embodiments, in response to the introducer needle  28  being inserted into the vasculature of the patient, flashback of blood may flow through the sharp distal tip  30  of the introducer needle  28  and may be visible to a clinician between the introducer needle  28  and the catheter  20  and/or at another location within the catheter assembly  16 . 
     In some embodiments, in response to confirmation via the blood flashback that the catheter  20  is positioned within vasculature of the patient, the needle assembly may be removed from the catheter assembly  16 . In some embodiments, when the needle assembly is coupled to the catheter assembly  16 , as illustrated, for example, in  FIG.  1 A , the introducer needle  28  of the needle assembly may extend through a septum disposed within the lumen of the catheter adapter  18 . 
     In some embodiments, the catheter system  14  may include one or more fluid tubes. In some embodiments, the fluid tubes may include any suitable tube through which fluid may flow to enter the catheter assembly  16 . In some embodiments, the catheter system  14  may include a clamp  36  through which a particular fluid tube may extend. In some embodiments, the fluid tubes may be connected to each other and/or one or more other elements to form a fluid pathway that extends between an IV bag or a fluid delivery device and the catheter assembly  16 . 
     In some embodiments, the fluid tubes may include an extension tube  34 , which may be coupled with the catheter assembly  16 . In further detail, in some embodiments, a distal end of the extension tube  34  may be integrated with the catheter adapter  18 , as illustrated, for example, in  FIG.  1 A . For example, the extension tube  34  may be integrated with the side port  22  of the catheter adapter  18 . In some embodiments, the extension tube  34  may be removably coupled to the catheter adapter  18 . In some embodiments, the fluid tubes may include another tube, which may be disposed proximal to the extension tube  34 . For example, the other tube may be coupled to the IV bag or the fluid delivery device. In some embodiments, the other tube may include an IV line that may extend between the IV bag and the extension tube  24 . 
     In some embodiments, the clamp  36  may selectively close off the particular fluid tube on which the clamp is disposed to prevent blood or another fluid from flowing through the particular fluid tube. In some embodiments, the clinician may activate the clamp  36  by removing a battery isolator  37  or flipping a switch. 
     In some embodiments, an adapter  38  may be coupled to a proximal end of the extension tube  34 . In some embodiments, the adapter  38  may include a Y-adapter or another suitable connector. In some embodiments, a needleless connector  40  may be coupled to the adapter  38 . In some embodiments, the adapter  38  and/or the needleless connector  40  may be used to connect the catheter  20  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  14  may include any suitable catheter assembly, and the clamp  36  may be coupled to any suitable fluid tube. In some embodiments, the extension tube  34  may extend from the proximal end  23  of the catheter adapter  18 . In some embodiments, the catheter assembly  16  may include a peripheral, central, or midline catheter assembly. In some embodiments, a peripherally inserted central catheter (“PICC”) assembly may include pigtail extension tubes, and a particular clamp  36  may be coupled to one or more of the pigtail extension tubes. 
     Referring now to  FIG.  1 B , in response to the clamp  36  being opened, fluid may flow through the fluid tubes, such as, for example, the extension tube  34  and/or the other fluid tube, and through the catheter assembly  16 . For example, fluid may be infused into the patient via a medical device coupled to the adapter  38  or blood may be withdrawn from the patient into a blood collection device coupled to the adapter  38 . In some embodiments, the clamp  36  may include a sensor  42 , which may be configured to detect the clamp  36  is closed and/or open. In some embodiments, the sensor  42  may be positioned to detect movement of the clamp  36 . 
     In some embodiments, the sensor  42  may include an optical sensor, a magnetic sensor, an electro-mechanical sensor, or another suitable type of sensor. As an example, the optical sensor may include a light barrier, which may be realized by a light emitting diode or a laser diode and a phototransistor. As an example, the magnetic sensor may include a reed relay or Hall sensor. As an example, the electromechanical sensor may include a switch or potentiometer. 
     Referring now to  FIG.  1 C , in response to the clamp  36  being closed, fluid may be prevented from flowing through the particular fluid tube on which the clamp  36  is disposed. In some embodiments, the clamp  36  may include a pinch clamp, which may pinch the particular fluid tube in response to movement of the clamp  36  to the closed position. In some embodiments, the clamp  36  may include an arm  44 , which may include a protrusion that contacts and pinches the particular fluid tube. In some embodiments, the clamp  36  may include any suitable clamp, and the sensor  42  may include any suitable sensor. In some embodiments, the sensor  42  may be disposed at various locations. 
     In some embodiments, the clamp  36  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.  FIGS.  1 A- 1 C  illustrate an example light  48 , according to some embodiments. In some embodiments, the status of the light  48  may change in response to the clamp  36  being closed for a predetermined duration of time. For example, the light  48  may turn on or may change color in response to the clamp  36  being closed for the predetermined duration of time. As another example, the light  48  may blink or change a rate of blinking in response to the clamp  36  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  16 . 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  16  is approaching. In some embodiments, the clinically recommended time to flush the catheter assembly  16  may be between about 6 hours and about 8 hours from the previous flushing of the catheter assembly  16 . In some embodiments, the predetermined duration of time may correspond to the clinically recommended time to flush the catheter assembly  16 . In some embodiments, a first alert may be provided by the clamp  36  in response to the clinically recommended time to flush the catheter assembly  16  approaching (such as, for example, in 30 minutes, 10 minutes, or 5 minutes), and a second alert may be provided by the clamp  36  in response to arrival of the clinically recommended time to flush the catheter assembly  16 . 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  48  may be disposed at various locations on the clamp  36 , which may be visible to the clinician. In some embodiments, the clamp  36  may include multiple lights  48 . In some embodiments, the light  48  may extend around a curved edge of the clamp  36 , as illustrated, for example, in  FIGS.  1 A- 1 C . 
     Referring now to  FIG.  1 D , an example clinician monitoring device  46  is illustrated, according to some embodiments. Examples of the clinician monitoring device  46  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  36  or as an alternative to the clamp  36 , the clinician monitoring device  46  may provide the alert. 
     In some embodiments, the clinician monitoring device  46  may include a display screen  50 , 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  50 , such as a portion  51  of the display screen  50  that lights up or changes color. In some embodiments, the portion  51  of the display screen  50  may blink or change a rate of blinking to provide the alert. In some embodiments, the clinician monitoring device  46  may include the light  48 , as described, for example, with respect to  FIG.  1 C . 
     Referring now to  FIG.  1 E , an example electronic health record  52  that may be presented on the display screen  50  of the clinician monitoring device  46  is illustrated, according to some embodiments. In some embodiments, an indication may be provided on the display screen  50  in response to opening and/or closing of the clamp  36 . In some embodiments, the indication may be provided on the display screen  50  in response to opening the clamp  36  for a particular predetermined duration of time and/or closing the clamp  36  for a particular predetermined duration of time. 
     In some embodiments, the indication may include one or more of the following: a time of day 56, a status  58 , and a duration of time  60 . In some embodiments, the duration of time  60  may include a duration of time the clamp  36  has been closed. In some embodiments, the status  58  may include “open” and may be adjacent to the time of day 56, indicating to the clinician the time of day at which the clamp  36  was opened. In some embodiments, the status  58  may include “closed” and may be adjacent to the time of day 56, indicating to the clinician the time of day at which the clamp  36  was closed. 
       FIG.  2    is as block diagram of an example flush management system (FM system)  62 , arranged in accordance with at least one embodiment described in the present disclosure. In some embodiments, the FM system  62  may include the clamp  63 . In some embodiments, the clamp  63  may include or correspond to the clamp  36  described with respect to  FIG.  1   . In some embodiments, the clamp  63  may include a computing system  64 . 
     In some embodiments, the computing system  64  may include a processor  66 , a memory  68 , a data storage  70 , and a communication unit  72 . In some embodiments, the processor  66 , the memory  68 , the data storage  70 , and the communication unit  72  may be communicatively coupled by a bus  74 . The bus  74  may include, but is not limited to, a controller area network (CAN) bus, a memory bus, a storage interface bus, a bus/interface controller, an interface bus, 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 . 
     In general, the processor  66  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  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 circuitry configured to interpret and/or to execute program instructions and/or to process data. Although illustrated as a single processor in  FIG.  2   , the processor  66  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  66  may be present on one or more different electronic devices. 
     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  70 , or the memory  68  and the data storage  70 . In some embodiments, the processor  66  may fetch program instructions from the data storage  70  and load the program instructions in the memory  68 . In some embodiments, after the program instructions are loaded into memory  68 , the processor  66  may execute the program instructions. 
     For example, in some embodiments, a flush module  76  may be included in the data storage  70  as program instructions. In some embodiments, the flush module  76  may be configured to manage flushing of the catheter line  32  and the catheter assembly  16 . The processor  66  may fetch the program instructions of the flush module  76  from the data storage  70  and may load the program instructions of the flush module  76  in the memory  68 . After the program instructions of the flush module  76  are loaded into the memory  68 , the processor  66  may execute the program instructions such that the computing system  64  may implement the operations associated with the flush module  76  as directed by the instructions. 
     The memory  68  and the data storage  70  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  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 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  66  to perform a certain operation or group of operations. 
     In some embodiments, one or more clinician monitoring devices  73  may be connected to the computing system  64  via a 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 configurations. Furthermore, 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 across which multiple devices may 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 communication of data in a variety of different communication protocols. In some embodiments, the clinician monitoring devices  73  may include or correspond to any of the clinician monitoring devices  46  described with respect to  FIG.  1   . 
     In some embodiments, the network  78  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  78  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  72  may be configured to transmit data to and receive data from the clinician monitoring devices  73  via the network  78 . In some embodiments, the communication unit  72  may also be configured to transmit and receive data from a display screen  80  and/or an electronic health record  82 . In some embodiments, the display screen  80  may include or correspond to the display screen  50  described with respect to  FIG.  1 D or  1 E . In some embodiments, the electronic health record  82  may include or correspond to the electronic health record  52  of  FIG.  1 E . In some embodiments, the flush module  76  may be configured to send and receive data via the communication unit  72 . 
     In some embodiments, the communication unit  72  may include a port for direct physical connection to the network  78  and/or another communication channel. For example, the communication unit  72  may include a universal serial bus (USB) port, a secure digital (SD) port, a category 5 cable (CAT-5) port, or similar port for wired communication with another device. In some embodiments, the communication unit  72  may include a wireless transceiver for exchanging data with the clinician monitoring device  46  or other communication channels using one or more wireless communication methods, including IEEE 802.11, IEEE 802.16, BLUETOOTH®, or another suitable wireless communication method. 
     In some embodiments, the communication unit  72  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  72  may also provide other conventional connections to the network  78  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  76  may manage flushing of a catheter assembly is now provided. In some embodiments, in response to a sensor  84  detecting the clamp is closed, the flush module  76  may be configured to start a timer  86 . In some embodiments, the sensor  84  may include or correspond to the sensor  42  described with respect to  FIG.  1   . In some embodiments, in response to the timer  86  reaching a predetermined duration of time, the flush module  76  may be configured to generate one or more alerts at the clamp and/or to transmit an alert signal over the network  78  to the clinician monitoring devices  73 , which may provide one or more alerts. In some embodiments, the alerts may include any of the alerts described with respect to  FIG.  1   . 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  76  may be configured to provide an indication in an electronic health record  88  of a patient in response to the sensors  84  detecting the clamp  63  is closed. In some embodiments, the electronic health record  88  may be stored and/or displayed on the clinician monitoring devices  73 . In some embodiments, the electronic health record  88  may include or correspond to the electronic health record  52  described with respect to  FIG.  1   . In some embodiments, the indication may include or correspond to the indication  54  described with respect to  FIG.  1   . 
     In some embodiments, in response to the sensors  84  detecting the clamp  63  is open or open for another predetermined duration of time, 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 of time to prevent opening of the clamp  63  when adequate flushing could not have occurred. 
     In some embodiments, in response to the sensors  84  detecting the clamp  63  is 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  63 . Additionally or alternatively, in some embodiments, in response to the sensors  84  detecting the clamp  63  is open for the other predetermined duration, the flush module  76  may be configured to transmit another alert signal over the network  78  to the clinician monitoring devices  73  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 electronic health record  88  of the patient in response to the sensors  84  detecting the clamp  63  is open for the other predetermined duration of time. In some embodiments, the other indication may include or correspond to the indication  54  described with respect to  FIG.  1   . 
     In some embodiments, one or more other sensors  90  may be configured to detect fluid flowing through a fluid tube, such as, for example the extension tube  34  of the catheter assembly  16  described with respect to  FIG.  1    or another fluid tube in fluid communication with the catheter assembly  16 . In some embodiments, the other sensors may include a flow sensor and/or a pressure sensor. Example devices that include flow sensors and/or pressure sensors are described in U.S. Patent Application No. 62/830,707, filed Apr. 8, 2019, Attorney Docket Number P-16330@, entitled “OCCLUSION DETECTION DEVICES, SYSTEMS, AND METHODS,” and U.S. Pat. No. 5,533,412, filed Jun. 7, 1995, entitled “PULSED THERMAL FLOW SENSOR SYSTEM,” which are hereby incorporated by reference in their entirety. In some embodiments, in response to the sensors  84  detecting the clamp  63  is open and the other sensors  90  detecting fluid flowing through the fluid tube, the flush module  76  may be configured to stop and/or reset the timer  86 . Although illustrated outside the clamp  63  in  FIG.  2   , it is understood that the other sensors  90  may be part of the clamp  63 . 
     In some embodiments, an external server may include one or more components of the computing system  64 . In some embodiments, the external server may be connected to the clamp  63  and/or the clinician monitoring device  73  via the network  78  or another network. Modifications, additions, or omissions may be made to the FM system  62  without departing from the scope of the present disclosure. 
     All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the invention and the concepts contributed by the inventor to furthering the art, and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention.