Syringe fluid pressure management device

Abstract

An adapter device assembly is provided that includes a housing defining a first chamber, 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. 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 irrigation syringe.

Description

Technical Field

[0001] Many aspects of this disclosure relate to pressure management adapter devices configured for use with syringes, such as flushing syringes for flushing catheters and other vascular access devices (VADs), and methods for regulating the pressure of fluid discharged from the syringe. Background Technology

[0002] Vascular angioplasty (VAD), such as intravenous (IV) catheters, is a commonly used therapeutic device. VADs are generally classified into two types: peripheral catheters and central venous catheters. Without proper maintenance, VADs can become blocked. To ensure correct use of VADs and prevent blockage, standard practices, including flushing procedures, have been established to maintain patency.

[0003] Different flushing procedures may involve different types and amounts of flushing solution. Commonly used flushing solutions are normal saline and / or heparin-locked solution. Flushing procedures can be enhanced using "start-stop," "push-pause" (also known as "push-pulse"), or turbulent flushing techniques to remove debris or residue from the catheter. During a flushing procedure, the user may apply force to the plunger rod, which can cause the pressure inside the canister to increase to 25 psi or higher, potentially leading to catheter or other VAD overpressure and interruption of therapy that could impair patient care. Furthermore, excessive pressure within the syringe during flushing can also cause a buildup of transient pressure in the vein near the catheter tip, potentially leading to thrombosis and venous rupture. High pressure can also cause the breakup of existing debris buildup, which can lead to embolism. If the practitioner cannot sense catheter obstruction, catheter buildup may be pushed into the bloodstream, potentially causing further problems.

[0004] Nurses and practitioners need to intermittently flush IV lines for multiple patients during typical shifts, which can make it difficult to determine and differentiate the infusion pressure limits for each individual patient. Average flushing pressure depends on a variety of factors, including catheter type, size, location, and patient condition. These factors present challenges in assessing whether the injection pressure is within one or more clinically acceptable limits. Furthermore, accurately identifying the infusion pressure limits for a specific patient can be even more difficult for each individual practitioner.

[0005] There is a need for a flushing syringe assembly that can be used with both manually administered fluids and fluids administered using an infusion pump, and provides controlled pulsatile flushing. Additionally, there is a need for devices to prevent catheter and vein injury due to transient pressure build-up during IV line flushing, in order to improve clinical outcomes. Summary of the Invention

[0006] A first aspect of this disclosure relates to an adapter device assembly comprising: a housing defining a first chamber, a distal end, and a proximal end, the first chamber being configured to retain fluid, the distal end being connectable to a patient connector, and the proximal end being connected to a flushing syringe to form a passage through which it is in fluid communication with the adapter device assembly; and a fluid pressure calibration module disposed within the first chamber, the fluid pressure calibration module being configured to determine the fluid pressure of fluid discharged from the flushing syringe. Attached Figure Description

[0007] Figure 1 This is a perspective view of an adapter device assembly connected to the flushing syringe assembly and the patient connector, according to a first exemplary embodiment of the present disclosure;

[0008] Figure 2 The diagram illustrates the connection between the patient connector and the flushing syringe assembly. Figure 1 Side view of the adapter device assembly;

[0009] Figure 3A The diagram shows... Figure 1 Top view of the adapter assembly before calibration;

[0010] Figure 3B The diagram shows... Figure 3A The adapter assembly is shown in a top view after calibration.

[0011] Figure 4A The illustration shows a top view of an adapter device assembly according to a second exemplary embodiment of the present disclosure;

[0012] Figure 4B The diagram shows... Figure 4A Bottom view of the adapter device components;

[0013] Figure 5 A perspective view of a third exemplary embodiment of the adapter device assembly is illustrated, which is shown as being connected to a patient connector;

[0014] Figure 6 A side perspective view of an adapter device assembly according to a fourth exemplary embodiment of the present disclosure is shown, the adapter device assembly being connected to a patient connector;

[0015] Figure 7A The illustration shows a side view of an adapter device assembly according to a fifth exemplary embodiment of the present disclosure, the adapter device assembly including an inflatable diaphragm in a collapsed configuration prior to fluid pressure measurement;

[0016] Figure 7B The diagram shows... Figure 7AThe side view of the adapter assembly shown illustrates an inflatable diaphragm in an inflatable configuration during fluid pressure measurement;

[0017] Figure 7C The diagram shows... Figure 7A The adapter assembly shown is a side view, and an inflatable diaphragm in a collapsed configuration is shown after fluid pressure measurement.

[0018] Figure 8A The illustration shows a side view of an adapter device assembly according to a sixth exemplary embodiment of the present disclosure before obtaining fluid pressure measurements;

[0019] Figure 8B The diagram illustrates the process after obtaining the calibrated fluid pressure values. Figure 8A Fluid pressure management device;

[0020] Figure 8C The diagram illustrates the situation after the fluid pressure value is obtained for the second time during the flushing procedure. Figure 8A and Figure 8B Fluid pressure management device;

[0021] Figure 9A The illustration shows a side view of an adapter device assembly including a chamber containing a bellows, according to a seventh exemplary embodiment of the present disclosure;

[0022] Figure 9B The diagram shows... Figure 9A An enlarged partial side view of the bellows-containing chamber of the adapter assembly shown.

[0023] Figure 10A The illustration shows a side view of an adapter device assembly according to an eighth exemplary embodiment of the present disclosure, the adapter device assembly including a pressure measuring chamber comprising a plurality of diaphragms;

[0024] Figure 10B The diagram shows the contents. Figure 9A An enlarged partial side view of the pressure measurement chambers containing multiple thin films shown;

[0025] Figure 11A A side view of an adapter device assembly according to a ninth exemplary embodiment of the present disclosure is illustrated;

[0026] Figure 11B The diagram shows... Figure 11A A partial side view of the measuring instrument of the adapter device assembly shown;

[0027] Figure 12A A side view of an adapter device assembly is shown, which includes a strain gauge according to a tenth exemplary embodiment of the present disclosure, the strain gauge being connected to the flushing syringe along the flushing syringe barrel and plunger;

[0028] Figure 12B The diagram shows... Figure 12A A magnified partial view of the strain gauge of the adapter device shown, with no pressure applied;

[0029] Figure 12C The diagram shows... Figure 12A A magnified partial view of the strain gauge of the adapter device shown, wherein the pressing force is applied centered on the plunger;

[0030] Figure 12D The diagram shows... Figure 12A A magnified partial view of the strain gauge of the adapter device shown, wherein pressure is applied along the outer edge of the plunger;

[0031] Figure 13 The illustration shows a side view of an adapter device assembly according to an eleventh exemplary embodiment of the present disclosure, the adapter device assembly including a pressure sensor disc connected to a flushing syringe assembly and a patient connector;

[0032] Figure 14A A side cross-sectional view of an adapter device assembly including a mechanical dial according to a twelfth exemplary embodiment of the present disclosure is shown, illustrating the adapter device assembly when there is no fluid flow.

[0033] Figure 14B The illustration shows the flow of fluid from the flushing syringe assembly through the adapter assembly. Figure 14B Adapter device components;

[0034] Figure 15A The illustration shows a side view of an adapter device assembly connected to a flushing syringe assembly, which first utilizes a fluid pressure column according to a thirteenth exemplary embodiment of the present disclosure;

[0035] Figure 15B The diagram shows... Figure 15A The side view of the fluid pressure column of the adapter assembly shown. Detailed Implementation

[0036] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can have other embodiments and can be practiced or carried out in various ways.

[0037] Rapidly injecting flushing fluid into an IV catheter can cause a transient pressure build-up in the vein near the catheter tip. This pressure can lead to venous injury and clinical complications such as thrombosis. The inability of practitioners to sense catheter blockages can cause catheter build-up to be pushed into the bloodstream, potentially causing significant problems for the patient. Embodiments of this disclosure address this pressing need by providing an adapter device that can be located between the patient connector and the flushing syringe, allowing practitioners (e.g., nurses and clinicians) to calibrate the flushing pressure and use the calibrated flushing pressure as a reference for subsequent flushing cycles. The adapter device assembly described herein provides a method to avoid catheter / vein injury due to transient pressure build-up during IV line flushing by clinicians / nurses, thereby improving clinical outcomes and increasing patient safety.

[0038] In use, the adapter device assembly can be used as follows: First, the needleless connector is connected to the catheter after catheter insertion. Then, the practitioner can infuse the proposed device and connect it to the needleless connector. The device is then calibrated by flushing the tubing, and the maximum flushing pressure obtained by the device is recorded. The calibration setting is then changed to the usage setting. During subsequent flushing, if the flushing pressure exceeds the calibrated value, the device is configured to provide a warning, such as an audible or visual indication. The device will stop the flushing process until the overpressure is resolved, and the device is reset by the user.

[0039] The adapter device components described herein can be used with pre-filled saline and heparin products to meet clinical needs, including syringes in external sterile packaging for aseptic field applications. Examples of products that can be used with the adapter device components described herein include the BD PosiFlush™ series of pre-filled syringes, providing a reliable and cost-effective alternative to vial-based flushing systems.

[0040] refer to Figure 1According to exemplary embodiments of the present disclosure, a first aspect of the present disclosure relates to an adapter device assembly 100 configured to connect to a patient connector 105 and a flushing syringe assembly 110. The illustrated adapter device assembly 100 generally includes a housing 120 defining a first chamber 122 and a fluid pressure calibration module 140, the first chamber 122 being configured to hold fluid. The fluid pressure calibration module 140 is configured to measure the pressure of fluid discharged from the flushing syringe assembly 110. The housing 120 includes a distal end 124 connectable to a patient connector 104 and a proximal end 126 connectable to the flushing syringe assembly 110 to form a passage 128 in fluid communication with the adapter device assembly 100. In the illustrated embodiment, the fluid pressure calibration module 140 is disposed within the first chamber 122. The flushing syringe assembly includes a distal end 112, a syringe barrel 114, and an elongated plunger rod 116. The elongated plunger rod 116 has a plunger stopper 117 attached to the distal end of the elongated plunger rod 116 and a thumb press portion 118 at the proximal end of the elongated plunger rod 116. The syringe barrel 114 is configured to contain fluid, and when a distally directed force is applied to the thumb press portion, causing the plunger rod 116 to move forward in a distal direction, the fluid is expelled from the syringe barrel. The plunger stopper forms a fluid-impermeable engagement with the inner wall of the syringe barrel, and the application of the distally directed force causes fluid in the syringe barrel 114 to be expelled from the distal end 112 of the flushing syringe assembly 110.

[0041] As understood in the art, the distal end 112 of the flushing syringe assembly is configured to connect to an intravenous catheter such that the catheter can be flushed, as further described herein. In one or more embodiments disclosed herein, an adapter assembly 100 is configured to connect to or be connectable to the distal end 112 of the flushing syringe assembly 110, and the adapter assembly 100 is disposed between the flushing syringe assembly and the intravenous catheter (not shown) during a flushing procedure. The connection between the adapter assembly 100 and the distal end 112 of the flushing syringe assembly 110 can be achieved by a threaded connection, for example by a Luer locking fitting. Alternatively, the connection between the adapter assembly 100 and the distal end 112 of the flushing syringe assembly 110 can occur by a Luer sliding fitting.

[0042] In one or more embodiments, the fluid pressure calibration module 140 includes a mechanical fluid pressure indicator ( Figure 2 and Figures 3A to 3B (Exemplary embodiments shown) or electromechanical fluid pressure indicator ( Figures 4A to 4B , Figures 12A to 12D and Figure 13(Exemplary embodiments shown in the figure). The fluid pressure calibration module 140 is configured to determine the fluid pressure of the fluid discharged from the flushing syringe assembly 110 when a distally directed force is applied to the plunger rod to force fluid away from the distal end of the syringe assembly.

[0043] Now for reference Figure 2 and Figures 3A to 3B The adapter assembly 100 includes a housing 120, which includes an outer surface 134 and a distal end 124. The distal end includes an internal thread 130, a proximal end 126 further including a Luer locking collar 132, and a slidable bracket 136. The outer surface 134 of the housing 120 further includes a graduated pressure scale 152 and two grooves 138 axially disposed along opposite sides of the housing. The slidable bracket 136 slidably engages with the grooves 138 along the outer surface 134 of the housing 120. The fluid pressure calibration module 140 includes a retractable sleeve 142, which further includes a bellows 148 disposed within a first chamber 122, connected to a connector 144 and a coupling 146, facilitating fluid communication between the patient connector 105, the retractable sleeve 142, and the flushing syringe assembly 110. The degree or amount of retraction of the bellows 148 is related to the calibrated fluid pressure value. For example, a larger degree of contraction can be associated with a higher pressure value compared to a smaller degree of contraction that may indicate a lower pressure value. The retractable sleeve 142 can be an elastomer that contracts due to fluid pressure and helps provide a visual indication of the pressure required to flush the line.

[0044] In use, clinicians obtain an initial calibration setting by flushing the syringe with flushing solution, causing the sleeve to contract according to the flushing pressure. The clinician can then use a sliding bracket on the adapter device to set the calibration setting to the level of the bellows contraction. During subsequent infusions, the clinician can ensure that the pressure does not exceed the initial setting limits. If the infusion pressure exceeds the calibration level, it will provide an early indication of in-catheter thrombus buildup, allowing for timely intervention for longer indwelling times.

[0045] According to one or more embodiments, a calibration mode is set during the initial flushing cycle after catheter insertion to determine the appropriate pressure, and the pressure obtained during the calibration mode is used as a reference for subsequent flushing cycles. Clinicians need to intermittently flush the tubing for multiple patients during shifts, making it difficult to know the infusion pressure limits for each patient. The procedure can become complicated due to differences in catheter length and type (multi-lumen vs. single-lumen), patient catheter insertion location, and patient vein and blood pressure. The advantage of the embodiments described here is that clinicians can set the calibration mode during use, regardless of the patient's age or condition; the device can be used for any patient population, from newborns to elderly patients.

[0046] Now for reference Figure 4A and Figure 4B A second embodiment of the adapter assembly 200 includes a housing 220, which includes an outer surface 234, a distal end 224 further including an internal thread 230, a proximal end 226 further including a Luer locking collar 232, and a calibration bracket 236 and a magnetic sensor 246 further including two external notches 237. The housing 220 defines an inner chamber 222 therethrough, which facilitates fluid communication between the patient connector 205 and a flushing syringe assembly 210 having a distal end 212 and a fluid passage 228 through which fluid is discharged. A fluid pressure calibration module 240 includes a electromechanical pressure indicator, which further includes a floating disk 242 containing a magnet 244 disposed within the inner chamber 222. The floating disk 242 moves linearly along the longitudinal axis of the inner chamber 222 in response to changes in fluid pressure discharged from the distal end 212 of the flushing syringe assembly 210. The outer surface 234 of the housing 220 further includes two grooves 238 axially disposed along opposite sides of the housing. The outer notch 237 of the calibration bracket 236 slidably engages with the grooves 238 along the outer surface 234 of the housing 220. A magnetic sensor 246 detects the location of the magnet 244. The calibration bracket 236 is configured to slide axially along the grooves 238 on the outer surface 234 of the housing 220 in response to changes in the position of the magnet 244 within the floating disk 242.

[0047] According to a second embodiment, in use, a housing is connected between a patient connector and a flushing syringe, which houses a calibration holder, a float with a magnet, and a Hall sensor with a magnet. During the first calibration infusion, the clinician pushes flushing solution from a pre-filled syringe, causing the float to move according to the flushing pressure. The clinician can then slide the calibration holder to the level of the float. During subsequent infusions, the clinician can ensure that the pressure does not exceed the initial set limit obtained during calibration. If the infusion pressure exceeds the calibration level, it results in an early indication of thrombus buildup in the catheter (e.g., via an audible alarm or visual indication) to allow for early action for a longer indwelling time.

[0048] Now for reference Figure 5A third embodiment of the adapter assembly 300 includes a first chamber 318, a second chamber 322 disposed adjacent to the first chamber 318, a housing 320 including an outer surface 334, a distal end 324 further including an internal thread 330, a proximal end 326 further including a Luer locking collar 332, and a sliding door 336. The first chamber 318 includes a first fluid pressure indicator scale 352 on the first chamber 318 and a reference plug disk 342 disposed within the first chamber 318, and the second chamber 322 includes a second fluid pressure indicator scale 354 on the second chamber 322 and a working plug disk 344 disposed within the second chamber 322. The reference plug disk 342 and the working plug disk 344 move linearly in response to changes in fluid pressure. The sliding door 336 is movable between a first position 346 and a second position 348. In the first position 346, the sliding door 336 is configured to allow fluid to flow into the first chamber 318 while preventing fluid from flowing into the second chamber 322 to obtain a calibrated fluid pressure value. In the second position 348, the sliding door 336 is configured to allow fluid to flow into the second chamber 322 while preventing fluid from flowing into the first chamber 318 to obtain a flushing pressure value. The housing 320 further includes a hydrophobic membrane 350 configured to separate the first chamber 318 and the second chamber 322 from the distal end 324. When pressure is applied by the user, the hydrophobic membrane 350 allows air to escape from the distal end and does not allow air in the chambers to compress.

[0049] In the third embodiment, the clinician infuses the device and then connects it between a syringe and a catheter / extension kit. The slider position of the device is set in calibration mode. When a flushing procedure is performed, the flushing pressure within the line acts on and pushes upwards the plug in the first chamber. The plug in the first chamber stops at the peak pressure achieved during the initial flush. This value is used as a reference for future readings. The slider moves to the second chamber, and subsequent readings are reflected in the second chamber. The device has a slightly tapered chamber with a vent at the top containing a plug. When a flushing procedure is performed, the flushing pressure within the line acts on and pushes upwards the plug. As the plug moves upwards due to the slight taper, interference continuously increases. The plug stops at the point indicating the peak pressure.

[0050] Now for reference Figure 6A fourth embodiment of the adapter assembly 400 includes a first conical chamber 418 adjacent to the second conical chamber 422, a housing 420 including an outer surface 434, a distal end 424 further including an internal thread 430, a proximal end 426 further including a Luer locking collar 432, and a sliding door 436. The first conical chamber 418 includes a first inflatable diaphragm 442 disposed within the first conical chamber 418 and a first fluid pressure indication scale 452 on the first conical chamber. The second conical chamber 422 includes a second inflatable diaphragm 444 disposed within the second conical chamber 422 and a second fluid pressure indication scale 454 on the second conical chamber 422, the second fluid pressure indication scale 454 further including a reference strip 456 for indicating the achieved peak pressure. The first inflatable diaphragm 442 and the second inflatable diaphragm 444 inflate in response to changes in fluid pressure. The first conical chamber 418 indicates a calibrated fluid pressure value, and the second conical chamber 422 indicates a flushing pressure value. A sliding door 436 is disposed on the housing 420 and is movable between a first position 446 and a second position 448. In the first position 446, the sliding door 436 is configured to allow fluid to flow into the first conical chamber 418 while preventing fluid from flowing into the second conical chamber 422 to obtain the calibrated fluid pressure value. In the second position 448, the sliding door 436 is configured to allow fluid to flow into the second conical chamber 422 while preventing fluid from flowing into the first conical chamber 418 to obtain the flushing pressure value.

[0051] In the fourth embodiment, during the flushing procedure, the flushing pressure within the tubing inflates the balloon, which is then pressed against the conical chamber. The upper surface of the balloon has ink or other types of markings. The inner surface of the scale has absorbent material. As the balloon inflates, it presses against the scale, and the ink is absorbed onto the scale, indicating the calibration marks. When the balloon deflates after the procedure, the ink absorbed by the strips indicates the peak pressure achieved. As the pressure increases, the contact area between the balloon and the conical shell increases, and the scale reading increases. The first chamber records the initial flushing pressure reading, and the device is then used in monitoring mode. When using a flushing syringe, a pressure reading is captured in the second chamber and compared to the reading obtained in the first chamber. If the reading in the second chamber exceeds the reference chamber value, this indicates an obstruction.

[0052] Now for reference Figures 7A to 7CA fifth embodiment of the adapter assembly 500 includes a conical chamber 518, a housing 520 including an outer surface 534, a distal end 524 further including an internal thread 530, and a proximal end 526 further including a Luer locking collar 532. The conical chamber 518 includes an inflatable diaphragm 542 disposed within the conical chamber 518 and a pressure scale 522 on the conical chamber 518. The pressure scale 522 includes an ink-absorbing strip 556 disposed on the conical chamber 518. The inflatable diaphragm 542 is positioned and configured to press against the ink-absorbing strip 556 on the conical chamber 518 and indicate a calibrated fluid pressure value.

[0053] In the fifth embodiment, during the flushing procedure, the flushing pressure within the pipeline inflates the balloon, which then presses against a conical chamber containing an ink-absorbing strip / paper strip and a scale. As the balloon deflates after the procedure, the ink absorbed by the strip indicates the achieved peak pressure. With increasing pressure, the contact area between the balloon and the conical shell increases, and the scale reading increases. A variation of this concept features a chamber with a preset acceptable pressure marking.

[0054] Now for reference Figures 8A to 8C A sixth embodiment of the adapter assembly 600 includes a distal end 624, a proximal end 626, a first chamber 618 extending from a housing 620, and a second chamber 622 extending from the housing 620 and adjacent to the first chamber 618. The housing includes an outer surface 634, a stop switch 636, a distal end 624 further including internal threads 630, and a proximal end 626 further including a Luer locking collar 632. The first chamber 618 includes a first graduated pressure scale 652 disposed on the first chamber 618 and a first plug 646 disposed within the first chamber 618. The second chamber 622 includes a second graduated pressure scale 654 disposed on the second chamber 622 and a second plug 648 disposed within the second chamber 622. The first chamber 618 provides a calibrated fluid pressure value, and the second chamber 622 provides a flushing pressure value. First stopper 646 and second stopper 648 move linearly along first chamber 618 and second chamber 622, respectively, in response to changes in fluid pressure. A stop switch 636 is movable between a first position 642 and a second position 644. In the first position 642, stop switch 636 is configured to allow fluid to flow into the first chamber 618 while blocking fluid flow into the second chamber 622 to obtain a calibrated fluid pressure value. In the second position 644, stop switch 636 is configured to allow fluid to flow into the second chamber 622 while blocking fluid flow into the first chamber 618 to obtain a flushing pressure value. After obtaining the calibrated fluid pressure value, the user can configure stop switch 636 to the second position 644 to obtain a flushing pressure value for comparison.

[0055] In the sixth embodiment, the clinician infuses the device and then connects it between the syringe and the catheter / extension kit. During the flushing procedure, flushing pressure within the line acts on the stopper and pushes it upwards. As the stopper moves upwards due to a slight taper in the device, interference continuously increases. The stopper stops at a point indicating peak pressure. The first chamber is a calibration chamber for recording the first reading, and a switch is then used to close the first chamber and activate the second chamber, which is the actual use chamber.

[0056] Now for reference Figures 9A to 9B A seventh embodiment of the adapter assembly 700 includes: a first chamber 718 extending from a housing 720 and a second chamber 722 extending from and adjacent to the first chamber 718, comprising a housing with an outer surface 734, a stop switch 736, a distal end 724 further including an internal thread 730, and a proximal end 726 further including a Luer locking collar 732. The first chamber 718 includes a first graduated pressure scale 752 disposed on the first chamber 718 and a bellows 746 disposed within the first chamber 718. The second chamber 722 includes a second graduated pressure scale 754 disposed on the second chamber 722 and a second bellows 748 disposed within the second chamber 722. The first chamber 718 provides a calibrated fluid pressure value, and the second chamber 722 provides a flushing pressure value. In response to changes in fluid pressure, the first bellows 746 and the second bellows 748 expand linearly along the first chamber 718 and the second chamber 722, respectively. The blocking switch 736 is movable between a first position 742 and a second position 743. In the first position 742, the blocking switch 736 is configured to allow fluid to flow into the first chamber 718 while blocking fluid flow into the second chamber 722 to obtain a calibrated fluid pressure value. In the second position 743, the blocking switch 736 is configured to allow fluid to flow into the second chamber 722 while blocking fluid flow into the first chamber 718 to obtain a flushing pressure value. After obtaining the calibrated fluid pressure value, the user can configure the blocking switch 736 to the second position 743 to obtain a flushing pressure value for comparison.

[0057] In the seventh embodiment, the clinician infuses the device and then connects it between a syringe and a catheter / extension kit. Because the device has chambers containing bellows, each fold of the bellows has a gradually increasing thickness from top to bottom. When a flushing procedure is performed, flushing pressure within the tubing acts on the bellows, and based on the pressure, the top few bellows folds will expand. Bellows folds with thicker cross-sections will require higher pressure to expand. The saline solution used to inflate the bellows in the calibration chamber is retained within the calibration chamber. The first chamber is the calibration chamber for recording the first reading. A switch is then used to close the first chamber and activate the second chamber, which is the actual use chamber.

[0058] Now for reference Figures 10A to 10B An eighth embodiment of the adapter device assembly 800 includes a first chamber 818 extending from a housing 820 and a second chamber 822 extending from and adjacent to the first chamber 818. The housing 820 includes an outer surface 834, a blocking switch 836, a distal end 824 further including an internal thread 830, and a proximal end 826 further including a Luer locking collar 832. The first chamber 818 includes a first graduated pressure scale 852 disposed on the first chamber 818, a first plurality of films 846 disposed within the first chamber 818, and a first distal end 858 including a first hydrophobic film 860 and a first vent port 862. The second chamber 822 includes a second graduated pressure scale 854 disposed on the second chamber 822, a second plurality of films 848 disposed within the second chamber 822, and a second distal end 868 including a second hydrophobic film (not shown but similar to the first hydrophobic film 860) and a second vent port (not shown but similar to the first vent port 862). The first chamber 818 provides a calibrated fluid pressure value, and the second chamber 822 provides a flushing pressure value. A first plurality of diaphragms 846 and a second plurality of diaphragms 848 increase their rupture pressure as they approach the first distal end 858 and the second distal end 868. As the fluid pressure in the first chamber 818 and the second chamber 822 increases, the first plurality of diaphragms 846 and the second plurality of diaphragms 848 rupture one after another to indicate the calibrated fluid pressure value or the flushing pressure value. A blocking switch 736 is movable between a first position 842 and a second position 844. In the first position 842, the blocking switch 836 is configured to allow fluid to flow into the first chamber 818 while blocking fluid to flow into the second chamber 822 to obtain the calibrated fluid pressure value. In the second position 844, the blocking switch 836 is configured to allow fluid to flow into the second chamber 822 while blocking fluid to flow into the first chamber 818 to obtain the flushing pressure value. After obtaining the calibrated fluid pressure value, the user can configure the stop switch 836 to the second position 844 to obtain the flushing pressure value for comparison with the actual flushing pressure reading.

[0059] In the use of the eighth embodiment, the clinician infuses the device and then connects it between a syringe and a catheter or extension kit. This embodiment has a chamber with a series of membranes. The pressure required to tear or rupture increases progressively from the bottom membrane to the top membranes. When a flushing procedure is performed, the flushing fluid pressure will cause one set of membranes (e.g., four membranes) to rupture. If subsequent use causes any additional membranes to rupture, this means there is a blockage. This concept can also be used in a dual-chamber configuration, where the first chamber is a calibration chamber for recording initial readings, and a switch is then used to block the first chamber and enable a second chamber, which is the actual use chamber.

[0060] Now for reference Figures 11A to 11B A ninth embodiment of the adapter assembly 900 includes: a fluid pressure calibration module 918 further comprising a bellows 912, a spring 914, and a dial 916; a housing 920 including an outer surface 934; a sliding door 936; a distal end 924 further comprising an internal thread 930; and a proximal end 926 further comprising a Luer locking collar 932. The dial 916 further includes the bellows 912, a reference pin 946, and an indicator pin 948. The reference pin 946 and the indicator pin 948 move in response to the expansion of the bellows 912 caused by an increase in flushing pressure to indicate a fluid pressure value. The reference pin 946 indicates a calibrated fluid pressure value, and the indicator pin 948 indicates a flushing pressure value. The sliding door 936 is movable between a first position 942 and a second position 944. In the first position 942, the sliding door 936 is configured to allow movement of the reference pin 946 while preventing movement of the indicator pin 948 to obtain the calibrated fluid pressure value. In the second position 944, the sliding door 936 is configured to allow movement of the indicator pin 948 while preventing movement of the reference pin 946 to obtain a flushing pressure value. After obtaining the calibration fluid pressure value, the user can configure the sliding door 936 to the second position 944 to obtain a flushing pressure value for comparison.

[0061] In the ninth embodiment, the clinician infuses the device and then connects it between a syringe and a catheter / extension kit. This embodiment features a dial with an indicator pin linked to a spring and bellows via a pivot point. The calibration indicator pin also retains a stop pin, which can be pushed but not pulled back. As the indicator pin moves due to pressure in the bellows, it also pushes the stop pin. The pin then stops at the peak pressure value. This embodiment is shown with dual indicator pins; the first pin is the calibration pin that records the first reading. The stop pin stops at the peak of the initial calibration reading. The user activates a switch, which then activates the second indicator pin, the regular use chamber. All subsequent readings are reflected in the second indicator pin.

[0062] Now for reference Figures 12A to 12DA tenth embodiment of the adapter assembly 1000 includes a mechanical pressure indicator 1030 comprising a strain gauge 1032 disposed on a thumb press portion 1018 of an elongated plunger rod 1016 of a flushing injector assembly 1010, and a potentiometer 1034 disposed along a syringe barrel 1014 of the flushing injector assembly 1010. The strain gauge 1032 is positioned relative to the elongated plunger rod 1016 and configured to indicate the force applied to the elongated plunger rod 1016. The potentiometer 1034 is positioned along the syringe barrel 1014 to indicate the volume of fluid discharged from the flushing injector assembly 1010. The strain gauge 1032 and the potentiometer 1034 are configured to read the flushing pressure by obtaining the ratio of the applied force to the infused volume. The obtained first flushing pressure value is used as a reference for subsequent readings.

[0063] In the tenth embodiment, this electromechanical device is mounted on a flushing syringe. The device may have a fixed slot and an adjustable retainer, with a barrel flange fitting within the fixed slot and the adjustable retainer for the plunger, similar to an arrangement in a syringe pump. The device can be configured to continuously record the volume infused and the force applied. A potentiometer linked to the plunger end is used to record the volume of fluid infused. A strain gauge attached to the plunger is used to record the applied force. The ratio of the applied force to the volume infused is recorded during the first flushing procedure. This serves as a reference for subsequent readings. If this ratio exceeds a certain value, equal to the initial calibration reading plus some predefined tolerance, an alarm indicating blockage can be triggered.

[0064] Now for reference Figure 13 An eleventh embodiment of the adapter assembly 1100 includes a fluid pressure calibration module 1118, which includes a pressure sensor disk 1130. The pressure sensor disk 1130 includes a distal end 1132 configured to connect to a patient connector 1105 and a proximal end 1134 configured to connect to a distal end 1112 of the irrigation syringe assembly 1110.

[0065] In the eleventh embodiment, the clinician connects the device between the syringe and the catheter / extension kit, and then infuses it. In this embodiment, a disposable adapter and a reusable electromechanical device may be present. The adapter has a diaphragm-based pressure sensor disc (similar to the pressure sensor disc used in an infusion pump kit), a male Luer connector on each side of the sensor, and a needleless connector. The electromechanical device is configured to track the movement of the diaphragm to detect pressure within the tubing during a flushing operation. A calibration mode is configured to store and display initial pressure readings, and then enable a practical use mode to run subsequent flushing operations. This reusable device may have a recess / slot for holding the syringe assembled with the pressure sensor adapter. In one or more embodiments, this electromechanical device will be compact, as it will only have pressure sensor detection, alarm, and signal processing circuitry. It will extend from the pressure sensor disc to the syringe barrel, surrounding approximately two-thirds of the barrel, making the scale visible to the user. This embodiment of the electromechanical device may be battery-powered, or, for weight reduction, it may be powered using a wired adapter.

[0066] Now for reference Figures 14A to 14B A twelfth embodiment of the adapter assembly 1200 includes a housing 1220, which includes a distal end 1224 configured to connect to a patient connector 1205, for example, via a Luer locking collar 1232. The adapter assembly further includes an outer surface 1234 and a proximal end 1226 configured to connect to a distal end 1212 of the flushing syringe assembly 1210, which may include internal threads 1230 or any other suitable feature for engaging the adapter assembly 1200. The adapter assembly 1200 further includes a first chamber 1218 and a dial 1236. The dial 1236 includes a fluid pressure gauge 1252 and a pointer 1250 connected to an indicating pin 1248, which provides a flushing pressure value in response to changes in the fluid flow rate through the first chamber 1218.

[0067] In the twelfth embodiment, the clinician connects the device to a syringe to remove air from the system, then connects the device to the patient connector and pushes the plunger on the syringe. Due to fluid pressure, the portion of the pointer in contact with the fluid path tilts, causing the pointer on the dial to also shift. As the pointer on the dial shifts, it pushes a reference pin within the dial. The reference pin remains in the same position, but the pointer in fluid contact returns to its original position. When the next flush is performed, the pointer on the dial will indicate whether the infusion pressure corresponds to the clinically safe range / limit.

[0068] Now for reference Figures 15A to 15BA thirteenth embodiment of the adapter assembly 1300 includes a housing 1320, which includes a distal end 1324, a proximal end 1326, a collar 1322, and a first chamber 1318. The first chamber 1318 includes a graduated pressure scale 1330 and extends vertically from the housing 1320. The flushing pressure value is indicated by the rise of fluid in the first chamber 1318.

[0069] In the use of the thirteenth embodiment, the clinician connects the device to a syringe to remove air from the system, and then connects the device to a patient connector. The clinician ensures the column remains vertically oriented to utilize gravity. A rotatable collar can be used for connection to the patient connector. The clinician pushes the plunger on the syringe, flushing the fluid level up in the vertical column during infusion, and the clinician observes and marks the maximum fluid level during the first flush (calibration flush). Instead of a mark, the device may have a float serving as a marker. When the next flush is performed, if the fluid level exceeds the calibration mark, this indicates that the infusion pressure corresponds to a clinically safe range or limit.

[0070] As used herein, the terms "correspondence" or "relative correspondence" encompass structural, functional, quantitative, and / or qualitative correlations or relationships between two or more objects, datasets, information, and / or the like when used to describe relationships between two or more elements (e.g., infusion pressure and clinical limits or ranges). Preferably, the correspondence or relationship can be used to transform one or more of the two or more objects, datasets, information, and / or the like to appear identical or equal. Correspondence can be evaluated using one or more of the following: thresholds, value ranges, fuzzy logic, pattern matching, machine learning evaluation models, or combinations thereof.

[0071] In this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or simply "embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in an embodiment" in various places throughout the specification does not necessarily refer to the same embodiment of this disclosure. Furthermore, specific features, structures, materials, or characteristics may be combined in one or more embodiments in any suitable manner.

[0072] Although this disclosure has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, this disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. An adapter device assembly comprising: A housing defining a first chamber, a distal end, and a proximal end, the first chamber being configured to retain fluid, the distal end being connectable to a patient connector, and the proximal end being connected to a flushing syringe to form a passage through which it is in fluid communication with an adapter assembly; as well as A fluid pressure calibration module is disposed in the first chamber and is configured to determine the fluid pressure of the fluid discharged from the flushing syringe.

2. The adapter device assembly as claimed in claim 1, wherein, The fluid pressure calibration module includes a mechanical fluid pressure indicator.

3. The adapter device assembly as claimed in claim 1, wherein, The fluid pressure calibration module includes an electromechanical fluid pressure indicator.

4. The adapter device assembly as claimed in claim 2, wherein, The mechanical fluid pressure indicator includes a retractable sleeve disposed in the first chamber and a sliding bracket disposed on the housing and configured to set a calibrated fluid pressure value.

5. The adapter device assembly as claimed in claim 4, wherein, The collapsible sleeve includes a bellows, and the slidable bracket is slidable to a position indicating the collapsible level of the bellows, the collapsible level being consistent with a calibrated fluid pressure value.

6. The adapter device assembly of claim 3, wherein, The electromechanical fluid pressure indicator includes a floating disk and a magnet disposed in the first chamber, and a calibration bracket disposed around the outside of the housing, the calibration bracket being configured to set a calibrated fluid pressure value.

7. The adapter device assembly of claim 6, wherein the floating disk and the magnet move linearly along the longitudinal axis of the first chamber in response to changes in fluid pressure.

8. The adapter device assembly of claim 6, wherein, The calibration bracket further includes a magnetic sensor to detect the location of the floating disk and the magnet.

9. The adapter device assembly of claim 2, wherein, The housing includes a second chamber disposed adjacent to the first chamber, the first chamber including a first stopper disc disposed within the first chamber, and the second chamber including a second stopper disc disposed within the second chamber.

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. The adapter device assembly of claim 10, further comprising a sliding door movable between a first position and a second position, wherein, In the first position, the sliding door is configured to allow fluid to flow into the first chamber while preventing fluid from flowing into the second chamber, and to obtain a calibrated fluid pressure value, and wherein, in the second position, fluid is prevented from flowing into the first chamber while allowing the fluid to flow into the second chamber, and a flushing pressure value is obtained.

12. The adapter device assembly of claim 11, further comprising a hydrophobic membrane separating the first chamber and the second chamber from the distal end of the housing.

13. The adapter device assembly of claim 2, wherein, The housing includes a first conical chamber adjacent to the second conical chamber, the first conical chamber including a first inflatable diaphragm disposed within the first conical chamber and a first fluid pressure indicator scale on the first conical chamber, and the second conical chamber including a second inflatable diaphragm disposed within the second conical chamber and a second fluid pressure indicator scale on the second conical chamber.

14. The adapter device assembly of claim 13, wherein, The first conical chamber indicates the calibrated fluid pressure value, and the second conical chamber indicates the flushing pressure value.

15. The adapter device assembly of claim 14, wherein, The second fluid pressure indication scale further includes stripes for indicating the peak pressure achieved.

16. The adapter device assembly of claim 14, further comprising a sliding door on the housing, the sliding door being configured to move between a first conical chamber for obtaining a calibrated fluid pressure value and a second conical chamber for obtaining a flushing pressure value.

17. The adapter device assembly of claim 2, wherein the housing further includes a single conical chamber, a pressure scale of an ink absorption strip on the interior of the single conical chamber, and the fluid pressure calibration module includes an inflatable diaphragm.

18. The adapter device assembly of claim 17, wherein, The inflatable diaphragm is positioned and configured to press against the ink-absorbing strip disposed on the single conical chamber and to indicate a calibrated fluid pressure value.

19. The adapter device assembly of claim 2, wherein the housing includes a first chamber extending from the housing and a second chamber extending from the housing adjacent to the first chamber, the first chamber including a first pressure scale and a first plug disposed within the first chamber, and the second chamber including a second pressure scale and a second plug disposed within the second chamber.

20. The adapter device assembly of claim 19, wherein, The first chamber provides a calibrated fluid pressure value, and the second chamber provides a flushing pressure value.

21. The adapter device assembly of claim 20, further comprising a blocking switch on the housing, the blocking switch being movable between the first chamber and the second chamber.

22. The adapter device assembly of claim 2, wherein the housing includes a first chamber extending from the housing and a second chamber extending from the housing adjacent to the first chamber, the first chamber including a first pressure scale and a first bellows disposed within the first chamber, and the second chamber including a second pressure scale and a second bellows disposed within the second chamber.

23. The adapter device assembly of claim 22, wherein, The first chamber provides a calibrated fluid pressure value, and the second chamber provides a flushing pressure value.

24. The adapter device assembly of claim 23, further comprising a blocking switch on the housing, the blocking switch being movable between the first chamber and the second chamber.

25. The adapter device assembly of claim 2, wherein, The housing includes a first chamber extending from the housing, the first chamber including a first graduated pressure scale, a plurality of thin films disposed within the first chamber, and a distal end including a hydrophobic membrane and a vent port.

26. The adapter device assembly of claim 25, wherein the plurality of films have a range of burst pressures that increase as they approach the distal end.

27. The adapter device assembly of claim 2, wherein, The fluid pressure calibration module includes a bellows, a spring, and a dial.

28. The adapter device assembly of claim 27, wherein, The dial further includes a bellows, a reference pin, a first indicator pin for indicating a calibrated fluid pressure value, and a second indicator pin for indicating a flushing pressure value, wherein the first indicator pin moves to indicate the flushing pressure value in response to the expansion of the bellows caused by an increase in flushing pressure.

29. The adapter device assembly of claim 28, further comprising a sliding door on the housing, the sliding door being movable between the first indicator pin and the second indicator pin.

30. The adapter device assembly of claim 3, wherein, The electromechanical pressure indicator includes a strain gauge and a potentiometer configured to read flushing pressure.

31. The adapter device assembly of claim 30, wherein, The strain gauge is positioned relative to the flushing injector plunger and configured to indicate the force applied to the flushing injector plunger, and the potentiometer is positioned along the flushing injector barrel to indicate the volume of fluid discharged from the flushing injector.

32. The adapter device assembly of claim 3, wherein, The fluid pressure calibration module includes a pressure sensor disk.

33. The adapter device assembly of claim 2, wherein the housing includes the first chamber and the dial.

34. The adapter device assembly of claim 33, wherein the dial further includes a fluid pressure gauge and a pointer connected to an indicator pin, which provides a flushing pressure value in response to changes in fluid flow rate.

35. The adapter device assembly of claim 2, wherein, The housing includes a first chamber extending vertically from the housing, the first chamber including a graduated pressure scale disposed on the first chamber.

36. The adapter device assembly of claim 35, wherein the flushing pressure value is indicated by the rise of fluid in the first chamber.

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