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BR-112021020184-B1 - CATHETER INSTALLATION

BR112021020184B1BR 112021020184 B1BR112021020184 B1BR 112021020184B1BR-112021020184-B1

Abstract

CATHETER ASSEMBLY CLAMP HAVING AN ACOUSTIC SENSOR. A method for managing flushing of a catheter assembly is a clamp configured to secure an extension tube of a catheter assembly. The clamp may include an acoustic sensor configured to detect fluid flowing through the extension tube. The clamp and acoustic sensor may be disposed outside the extension tube. The clamp may include a pinch clamp or a non-pinch clamp. The acoustic sensor may be incorporated into the clamp. The method may include detecting, through the acoustic sensor, fluid flowing through the extension tube.

Inventors

  • S. Ray Isaacson

Assignees

  • BECTON, DICKINSON AND COMPANY

Dates

Publication Date
20260317
Application Date
20200407
Priority Date
20200406

Claims (3)

  1. 1. Catheter assembly (16) comprising: a catheter adapter (18); an extension tube (34) coupled to the catheter adapter (18); a clamping device (36) having an open position and a closed position, wherein the open position allows fluid to flow through the extension tube (34), and wherein the closed position prevents fluid from flowing through the extension tube (34), the clamping device (36) comprising: a first arm (47) having a protrusion forming a clamping surface in which is embedded an acoustic sensor (42) configured to contact the extension tube (34) when the clamping device (36) is in the closed or open positions, and to detect whether fluid is flowing through the extension tube (34); a second arm (47) opposite the first arm (47), wherein the distal ends of the first arm (47) and the second arm (47) are connected by means of a hinge (92), and wherein the proximal ends of the first arm (47) and the second arm (47) are selectively engageable to cause the protrusion to clamp the extension tube (34) positioned between the first and second arms (47, 47); CHARACTERIZED by a first microphone embedded in the second arm (47); a second microphone embedded in the second arm (47) proximal to the first microphone; and a computer system (64) to detect, from signals coming from the first and second microphones, whether fluid is flowing inside the extension tube (34).
  2. 2. Catheter assembly (16), according to claim 1, CHARACTERIZED in that the acoustic sensor (42) is a third microphone.
  3. 3. Catheter assembly (16), according to claim 1, CHARACTERIZED in that it further comprises a light (48), wherein the computing system (64) is further configured to: in response to detecting that fluid is not flowing inside the extension tube (34), start a timer (75) for a predetermined amount of time; in response to the timer (75) having elapsed, cause the light (48) to provide an indication on the clamping device (36) that fluid has not flowed through the extension tube (34) for the predetermined amount of time; detect, from signals received from the first and second microphones, that fluid is flowing in a distal direction inside the extension tube (34); and in response to detecting that fluid is flowing in the distal direction inside the extension tube (34), stop causing the light (48) to provide the indication.

Description

BACKGROUND [001] Catheters are commonly used for a variety of infusion therapies. For example, catheters can be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to withdraw blood from the patient. [002] A common type of catheter is a peripheral IV through-needle catheter ("PIVC"), a peripherally inserted central catheter ("PICC"), or a midline catheter. As its name indicates, the through-needle catheter can be mounted on an introducer needle having a sharp distal tip. The sharp distal tip can be used to puncture the patient's skin and vasculature. Insertion of the catheter into the vasculature may follow puncture of the vasculature by the needle. The needle and catheter are generally inserted at a shallow angle through the skin into the patient's vasculature with a bevel of the needle facing away from the patient's skin. After confirming placement of the needle in the vasculature, the clinician may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood draw and/or fluid infusion. [003] In some instances, the catheter may become unusable or compromised due to catheter occlusion over time. In response to catheter occlusion, the catheter may need to be removed and replaced with a new catheter. Catheter occlusions can be thrombotic, resulting from the formation of a thrombus within or around a distal tip of the catheter. Catheter occlusions can also be non-thrombotic, resulting from precipitates, mechanical obstructions, and other factors. Additionally, catheter occlusions can lead to catheter infection, pulmonary embolism, post-thrombotic syndrome, and other negative health outcomes. Clinicians can regularly flush the catheter to prevent occlusion and prolong the catheter's dwell time. [004] The subject matter claimed in the present invention is not limited to embodiments that resolve any disadvantages or that operate only in environments such as those described above. Rather, such background is provided only to illustrate an area of exemplary technology where some implementations described in the present invention may be put into practice. SUMMARY [005] The present disclosure relates generally to vascular access systems and related devices and methods. In some embodiments, a method of managing flushing of a catheter assembly may include providing a fastener for an extension tube of the catheter assembly. In some embodiments, the fastener may include an acoustic sensor, which may be configured to detect that the fastener is open or fluid is flowing through the extension tube of the catheter assembly. In some embodiments, the acoustic sensor may be configured to detect that the fastener is closed or fluid is not flowing through the extension tube of the catheter assembly. [006] In some embodiments, the method may include initiating a timer in response to the acoustic sensor detecting that the fastener is closed. In some embodiments, the method may include providing an alert in response to the timer reaching a predetermined time duration. 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. [007] 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 instruct 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 the status of a light. In some embodiments, an indication may be provided in a patient's electronic health record in response to the acoustic sensor detecting that the fastener is closed. [008] In some embodiments, the acoustic sensor can be configured to detect that the fastener is open. In some embodiments, in response to the acoustic sensor detecting that the fastener is open for another predetermined duration of time, the timer can be stopped and/or reset. In some embodiments, in response to the acoustic sensor detecting that the fastener is open for another predetermined duration of time, another alert signal can be transmitted over the network to the monitoring device to stop the alert or provide another alert. In some embodiments, another indication can be provided in the patient's electronic health record in response to the acoustic sensor detecting that the fastener is open for another predetermined duration of time. [009] 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