CN-122003264-A - Injector fluid pressure management device

Abstract

An adapter device assembly is provided that includes a housing defining a first chamber, a distal end and a proximal end, the housing configured to hold a fluid, the distal end connectable with a patient connector, the proximal end connected to a flush syringe to form a passageway therethrough in fluid communication with the adapter device assembly. The adapter device assembly further includes a fluid pressure calibration module disposed within the first chamber, the fluid pressure calibration module configured to determine a fluid pressure of fluid expelled from the flush syringe.

Inventors

• GADHINGLAJKAR SHRIPAD
• S. PRASAD
• R. R. Putucard

Assignees

• 贝克顿·迪金森公司

Dates

Publication Date

20260508

Application Date

20241015

Priority Date

20231016

Claims (20)

1. 1. An adapter device assembly, comprising: A housing defining a first chamber configured to hold a fluid, a distal end connectable with a patient connector, and a proximal end connected to a flush syringe to form a passageway therethrough in fluid communication with the adapter device assembly, and A fluid pressure calibration module disposed within the first chamber, the fluid pressure calibration module configured to determine a fluid pressure of fluid discharged from the flush syringe.
2. 2. The adapter device assembly of claim 1, wherein the fluid pressure calibration module comprises a mechanical fluid pressure indicator.
3. 3. The adapter device assembly of claim 1, wherein the fluid pressure calibration module comprises an electromechanical fluid pressure indicator.
4. 4. The adapter device assembly of claim 2, wherein the mechanical fluid pressure indicator comprises a collapsible sleeve disposed within the first chamber and a slidable bracket disposed on the housing and configured to set a calibrated fluid pressure value.
5. 5. The adapter device assembly of claim 4, wherein the collapsible sleeve comprises a bellows and the slidable bracket is slidable to a position indicating a collapse level of the bellows, the collapse level being consistent with the calibrated fluid pressure value.
6. 6. The adapter device assembly of claim 3, wherein the electromechanical fluid pressure indicator includes a floating disc and a magnet disposed within the first chamber, and a calibration bracket disposed about an exterior of the housing, the calibration bracket configured to set a calibrated fluid pressure value.
7. 7. The adapter device assembly of claim 6, wherein the floating disc and the magnet move linearly along a longitudinal axis of the first chamber in response to a change in fluid pressure.
8. 8. The adapter device assembly of claim 6, wherein the calibration stand further comprises a magnetic sensor to detect the location of the floating disk and the magnet.
9. 9. The adapter device assembly of claim 2, wherein the housing includes a second chamber disposed adjacent the first chamber, the first chamber including a first plug disk within the first chamber, and the second chamber including a second plug disk disposed within the second chamber.
10. 10. The adapter device assembly of claim 9, wherein the first chamber includes a reference plug and the second chamber includes a working plug that moves linearly in response to changes in fluid pressure.
11. 11. The adapter device assembly of claim 10, further comprising a slidable door movable between a first position and a second position, wherein in the first position the slidable door is configured to allow fluid flow into the first chamber while blocking fluid flow into the second chamber and obtaining a calibrated fluid pressure value, and wherein in the second position fluid flow into the first chamber is blocked while allowing fluid flow into the second chamber and obtaining a flush pressure value.
12. 12. The adapter device assembly of claim 11, further comprising a hydrophobic membrane separating the first and second chambers from a distal end of the housing.
13. 13. The adapter device assembly of claim 2, wherein the housing comprises a first conical chamber adjacent a second conical chamber, the first conical chamber comprising a first inflatable membrane disposed within the first conical chamber and a first fluid pressure indicating scale on the first conical chamber, and the second conical chamber comprising a second inflatable membrane disposed within the second conical chamber and a second fluid pressure indicating scale on the second conical chamber.
14. 14. The adapter device assembly of claim 13, wherein the first conical chamber is indicative of a calibrated fluid pressure value and the second conical chamber is indicative of a flush pressure value.
15. 15. The adapter device assembly of claim 14, wherein the second fluid pressure indication scale further comprises a band for indicating the peak pressure achieved.
16. 16. The adapter device assembly of claim 14, further comprising a sliding door on the housing, the sliding door configured to move between the first conical chamber for obtaining the calibrated fluid pressure value and the second conical chamber for obtaining the flush pressure value.
17. 17. The adapter device assembly of claim 2, the housing further comprising a single conical chamber, a pressure scale comprising an ink absorbing strip on an interior of the single conical chamber, and the fluid pressure calibration module comprising an inflatable membrane.
18. 18. The adapter device assembly of claim 17, wherein the inflatable membrane is positioned and configured to press against the ink absorbing strip disposed on the single conical chamber and indicate a calibrated fluid pressure value.
19. 19. The adapter device assembly of claim 2, the housing comprising the first chamber extending from the housing and a second chamber extending from the housing adjacent the first chamber, the first chamber comprising a first graduated pressure scale and a first plug disposed within the first chamber, and the second chamber comprising a second graduated pressure scale and a second plug disposed within the second chamber.
20. 20. The adapter device assembly of claim 19, wherein the first chamber provides a calibrated fluid pressure value and the second chamber provides a flush pressure value.

Description

Injector fluid pressure management device Technical Field Aspects of the present disclosure relate to pressure management adapter devices configured for use with syringes, such as flush syringes for flush catheters and other Vascular Access Devices (VADs), and methods of regulating the pressure of fluid expelled from a syringe. Background VADs such as Intravenous (IV) catheters are common therapeutic devices. There are two general classifications of VADs, peripheral catheters and central venous catheters. Without proper maintenance, the VAD may be blocked. To ensure proper use of the VAD and no occlusion, practice standards including flushing procedures have been developed to maintain patency. Different wash procedures may involve different types and amounts of wash solutions. Common flushing solutions are physiological saline and or heparin lock solutions. The flushing procedure may be enhanced by using "start-stop", "push-pause" (also referred to as "push-pulse") or turbulent flushing techniques to remove debris or residue from the catheter. During a flush procedure, the user may exert a force on the plunger rod that may cause the pressure within the barrel to increase up to 25 psi and above, which may cause over-pressurization of the catheter or other VAD, and may also cause interruption of therapy that may impair patient care. In addition, excessive pressure within the syringe during flushing can also lead to transient pressure build-up within the vein near the catheter tip, potentially leading to thrombosis and vein bursting. The high pressure may also cause breaking up of existing debris accumulation, which may lead to embolism. If the practitioner is unable to sense catheter occlusion, it may result in catheter accumulation being pushed into the blood stream, which may lead to further problems. Nurses and practitioners need to flush the IV lines of multiple patients intermittently during a typical shift, which can make it difficult to determine and distinguish the infusion pressure limits for each individual patient. The average flush pressure depends on a variety of factors including catheter type, size, location and patient condition. These various factors present challenges in assessing whether the injection pressure is within clinically acceptable limit(s). Furthermore, it may be more difficult for each different practitioner to accurately discern the infusion pressure limits of a particular patient. There is a need for a flush syringe assembly that can be used with manually administered fluids and fluids administered using infusion pumps and that provides controlled pulsatile flushing. Additionally, there is a need to provide a means for practitioners to avoid catheter and vein damage due to transient pressure build-up during IV line flushing to improve clinical outcome. Disclosure of Invention A first aspect of the present disclosure relates to an adapter device assembly including a housing defining a first chamber configured to hold a fluid, a distal end connectable with a patient connector, and a proximal end connected to an irrigation syringe to form a passageway therethrough in fluid communication with the adapter device assembly, and a fluid pressure calibration module disposed within the first chamber, the fluid pressure calibration module configured to determine a fluid pressure of the fluid expelled from the irrigation syringe. Drawings Fig. 1 is a perspective view of an adapter device assembly connected to a flush syringe assembly and a patient connector according to a first exemplary embodiment of the present disclosure; FIG. 2 illustrates a side view of the adapter device assembly of FIG. 1 connected to a patient connector and flush syringe assembly; FIG. 3A illustrates a top view of the adapter device assembly of FIG. 1 prior to calibration; FIG. 3B illustrates a top view of the adapter device assembly of FIG. 3A after calibration; FIG. 4A illustrates a top view of an adapter device assembly according to a second exemplary embodiment of the present disclosure; FIG. 4B illustrates a bottom view of the adapter device assembly of FIG. 4A; FIG. 5 illustrates a perspective view of a third exemplary embodiment of an adapter device assembly shown connected to a patient connector; FIG. 6 illustrates a side perspective view of an adapter device assembly according to a fourth exemplary embodiment of the present disclosure, the adapter device assembly shown connected to a patient connector; FIG. 7A illustrates a side view of an adapter device assembly including an inflatable membrane in a deflated configuration prior to fluid pressure measurement, in accordance with a fifth exemplary embodiment of the present disclosure; FIG. 7B illustrates a side view of the adapter device assembly shown in FIG. 7A, showing the inflatable membrane in an inflated configuration during fluid pressure measurement; FIG. 7C illustrates a side view of the adapter device assembly shown in FIG. 7A and showing the infl