IP Library Granted Patent US 12708708
Granted Patent B2
US 12708708 · App. 17/587,796 · Granted Aug 18, 2026

Patency checking system

Inventors: Yiping Ma (Layton, UT); Joseph Spataro (Cottonwood Heights, UT); Huy Tran (Riverton, UT); Kathryn Willybiro (Park City, UT); Jonathan Karl Burkholz (Salt Lake City, UT); Bart D. Peterson (Farmington, UT)
Assignee: Becton, Dickinson and Company
A61M5/158A61M39/1011A61M39/22A61M2005/1588
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Quick Facts
Patent No.
US 12708708
App. No.
17/587,796
Granted
Aug 18, 2026
Kind
B2
Abstract

A patency checking system, may include a fluid path to be coupled to an intravenous (IV) device at a distal end of the fluid path; a patency port formed along a length of the fluid path; and a plunger fluidically coupled to the fluid path at the patency port to selectively draw blood into the fluid path to confirm patency of the fluid path.

Claims (45)

1 . An intravenous (IV) system, comprising:

(1) a patency checking system comprising:

a housing that forms a three-way valve comprising a fluid path coupler forming a flush port, a fluidic port, and a patency port, the housing including a valve actuator having a first position in which the flush port and the patency port are fluidly coupled and isolated from the fluidic port and a second position in which the patency port and the fluidic port are fluidly coupled and isolated from the flush port;

a syringe comprising a barrel and a plunger that is configured to be actuated from a non-drawn state to a drawn state by withdrawing the plunger proximally within the barrel, wherein the barrel is mechanically coupled directly to the patency port, wherein the syringe further comprises a spring that mechanically couples the plunger to an interior surface of the barrel, wherein the spring is biased to pull the plunger distally into the barrel and to prevent the plunger from being removed from the barrel;

a force sensor to detect a force used to withdraw the plunger from the non-drawn state to the drawn state; and

a notification module that is configured to receive the force from the force sensor, the notification module being further configured to compare the force to a threshold and to output a first indication when the force is below the threshold and to output a second indication when the force is above the threshold;

(2) an IV device that is separate from the patency checking system, the IV device comprising:

a catheter at a distal end of the IV device, wherein the catheter is configured to be inserted into a patient's vasculature; and

translucent tubing that extends proximally from the catheter to a proximal coupler, wherein the proximal coupler is configured to be coupled to the fluid path coupler of the patency checking system to thereby enable the patency checking system to be positioned off-site from the catheter of the IV device, the catheter and the translucent tubing forming a fluid path into and out from the patient's vasculature; and

(3) a fluid flush reservoir that is fluidly coupled to the fluidic port, the fluid flush reservoir containing a flushing fluid;

wherein the patency checking system is further configured such that, while the catheter of the IV device remains within the patient's vasculature and the patency checking system is positioned off-site from the catheter of the IV device, the following steps are performed without handling the IV device:

when the valve actuator is in the first position and the plunger is in the non-drawn state, the plunger may be withdrawn to the drawn state to draw blood from the patient's vasculature proximally into the translucent tubing to provide a visual indication of patency of the catheter and then the spring pulls the plunger distally to automatically expel the blood from the translucent tubing back into the patient's vasculature, and wherein the force sensor detects the force used to withdraw the plunger and the notification module compares the force used to withdraw the plunger to the threshold, and wherein, when the force used to withdraw the plunger is below the threshold, the notification module outputs the first indication to notify the clinician that the IV device maintains its patency whereas, when the force used to withdraw the plunger is above the threshold, the notification module outputs the second indication to notify the clinician that the IV device does not maintain its patency;

when the valve actuator is in the second position and the plunger is in the non-drawn state, the plunger may be withdrawn to the drawn state to draw the flushing fluid from the fluid flush reservoir into the syringe through the fluidic port and the patency port; and

when the valve actuator is moved to the first position after the plunger has been withdrawn into the drawn state to fill the syringe with flushing fluid, the spring causes the plunger to be advanced back to the non-drawn state to automatically force the flushing fluid from the syringe through the patency port and the flush port to thereby flush the fluid path formed by the translucent tubing and the catheter.

2 . The IV system of claim 1 , wherein the barrel includes measurement indicators for measuring a volume of gas that is drawn into the syringe when the plunger is withdrawn to the drawn state while the valve actuator is in the first position.

3 . The IV system of claim 1 , wherein the syringe includes a locking device to lock the plunger in the non-drawn state.

4 . The IV system of claim 3 , wherein the locking device is configured to lock the plunger in the drawn state after the flushing fluid has been drawn into the syringe.

5 . The IV system of claim 1 , further comprising a linear motor that advances the plunger between the non-drawn state and the drawn state.

6 . The IV system of claim 5 , wherein the linear motor advances the plunger a set distance based on a length of the fluid path.

7 . A method of operating the IV system of claim 1 , the method comprising:

without handling the IV device, positioning the valve actuator in the first position;

with the valve actuator in the first position and without handing the IV device, withdrawing the syringe from the non-drawn state to the drawn state to attempt to draw blood proximally into the fluid path;

after attempting to draw blood into the fluid path and without handling the IV device, positioning the valve actuator in the second position;

with the valve actuator in the second position and without handling the IV device, withdrawing the syringe from the non-drawn state to the drawn state to draw flushing fluid into the syringe;

after drawing flushing fluid into the syringe and without handling the IV device, positioning the valve actuator in the first position; and

with the valve actuator in the first position and without handling the IV device, allowing the spring to advance the syringe from the drawn state to the non-drawn state to force the flushing fluid through the fluid path formed by the translucent tubing and the catheter.

8 . The method of claim 7 , wherein the valve actuator is positioned in the first position after attempting to draw blood into the fluid path upon determining that insufficient blood was drawn into the fluid path.

9 . A method for checking patency of an IV device during indwell without handling the IV device during indwell, the method comprising:

obtaining a patency checking system comprising:

a housing that forms a three-way valve comprising a fluid path coupler forming a flush port, a fluidic port, and a patency port, the housing including a valve actuator having a first position in which the flush port and the patency port are fluidly coupled and isolated from the fluidic port and a second position in which the patency port and the fluidic port are fluidly coupled and isolated from the flush port;

a syringe comprising a barrel and a plunger that is configured to be actuated from a non-drawn state to a drawn state by withdrawing the plunger proximally within the barrel, wherein the barrel is mechanically coupled directly to the patency port, wherein the syringe further comprises a spring that mechanically couples the plunger to an interior surface of the barrel, wherein the spring is biased to pull the plunger distally into the barrel and to prevent the plunger from being removed from the barrel, wherein the barrel further comprises a locking device to lock the plunger in place within the barrel;

a force sensor to detect a force used to withdraw the plunger from the non-drawn state to the drawn state; and

a notification module that is configured to receive the force from the force sensor, the notification module being further configured to compare the force to a threshold and to output a first indication when the force is below the threshold and to output a second indication when the force is above the threshold;

coupling the patency checking system to an IV device that includes a catheter and translucent tubing, the catheter being at a distal end of the IV device and being configured to be inserted into a patient's vasculature, the translucent tubing extending proximally from the catheter to a proximal coupler, wherein the proximal coupler is configured to be coupled to the fluid path coupler of the patency checking system such that the patency checking system is positioned off-site from the catheter of the IV device when the catheter is inserted into the patient's vasculature and while the catheter and the translucent tubing form a fluid path into and out from the patient's vasculature;

coupling a fluid flush reservoir to the fluidic port, the fluid flush reservoir containing a flushing fluid; and

while the catheter of the IV device is inserted into the patient's vasculature and the patency checking system is positioned off-site from the catheter of the IV device, checking the patency of the IV device without handling the IV device by performing the following:

with the valve actuator in the first position, withdrawing the plunger from the non-drawn state to the drawn state to draw blood from the patient's vasculature proximally into the translucent tubing to provide a visual indication of patency of the catheter;

releasing the plunger to thereby allow the spring to pull the plunger distally back into the non-drawn state to automatically expel the blood from the translucent tubing back into the patient's vasculature;

while the plunger is withdrawn from the non-drawn state to the drawn state, detecting, via the force sensor, the force used to withdraw the plunger;

comparing, via the notification module, the force used to withdraw the plunger to the threshold such that when the force used to withdraw the plunger is below the threshold, the notification module outputs the first indication to notify the clinician that the IV device maintains its patency whereas, when the force used to withdraw the plunger is above the threshold, the notification module outputs the second indication to notify the clinician that the IV device does not maintain its patency;

moving the valve actuator to the second position;

with the valve actuator in the second position, withdrawing the plunger from the non-drawn state to the drawn state to draw the flushing fluid from the fluid flush reservoir into the syringe through the fluidic port and the patency port;

activating the locking device to retain the plunger in the drawn state while the flushing fluid is drawn into the syringe;

moving the valve actuator to the first position; and

with the valve actuator in the first position, releasing the locking device to allow the spring to advance the plunger back to the non-drawn state to automatically force the flushing fluid from the syringe through the patency port and the flush port to thereby flush the fluid path formed by the translucent tubing and the catheter.