Priming adapter for infusion line

Abstract

A priming device includes a body, a connection member configured to mate with a corresponding connector of a closed system transfer device, an elastomeric member connected to the body and moveable relative to the body between a first position where the elastomeric member and the body define a first volume and a second position where the elastomeric member and the body define a second volume, where the second volume is larger than the first volume, with the first and second volumes in fluid communication with the connection member, and a handle connected to the elastomeric member and configured to move the elastomeric member between the first and second positions.

Description

PRIMING ADAPTER FOR INFUSION LINECROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority to United States Provisional Application No. 63 / 581,759 entitled “Priming Adapter for Infusion Line” filed September 11, 2023, the disclosure of which is hereby incorporated by reference in its entirety.BACKGROUND OF THE INVENTIONField of the Disclosure

[0002] The present disclosure relates generally to concepts for priming an infusion line.Description of the Related Art

[0003] Health care providers reconstituting, transporting, and administering hazardous drugs, such as cancer treatments, can put health care providers at risk of exposure to these medications and present a hazard in the health care environment. Unintentional chemotherapy exposure can affect the nervous system, impair the reproductive system, and bring an increased risk of developing blood cancers in the future. Some drugs must be dissolved or diluted before they are administered, which involves transferring a solvent from one container to a sealed vial containing the drug in powder or liquid form, by means of a needle. Drugs may be inadvertently released into the atmosphere in gas form or by way of aerosolization, during the withdrawal of the needle from the vial and while the needle is inside the vial, if any pressure differential between the interior of the vial and the surrounding atmosphere exists. In order to reduce the risk of health care providers being exposed to toxic drugs, the transfer of these drugs is accomplished by utilizing a closed system transfer device or system.

[0004] During the administration of chemotherapy via intravenous (IV) infusion, three challenges have been observed which cause significant inefficiency. Given these procedures occur in an outpatient oncology setting, the consequence of delays can have significant effects on throughput of patients through the facility and the patients’ personal schedules.

[0005] Infusing primed saline: Because chemotherapy drugs are hazardous, IV lines are commonly primed first with a base solution (such as saline) before either being connected to the bag containing the drug, or before the drug is injected via syringe into the bag of base solution. Given that IV lines can often contain up to 30mL of fluid it can take up to approximately 15 min at the prescribed rate (such as 120 mL / hr.) for the saline in the line to be infused to the patient, and for the drug to first enter the patient.

[0006] Bag Overfill: Measuring the precise volume of the bag to be infused after the drug has been prepared by the pharmacist can pose a challenge. It is often the case that a pharmacist will receive a prefilled saline bag with some inherent variability (approximately +10%) in its volume, and then add additional volume when injecting the drug to be infused (approximately lO-lOOmL). As a result, the nurse administering the drug has a precise amount of drug diluted into a somewhat imprecise amount of saline. In the industry, this is commonly referred to as “bag overfill” and is observed when the volumetric displacement pump has finished delivering the intended volume to be infused, but the clinician observes that there is still fluid in the bag which contains a portion of the drug intended to be infused. The clinician must therefore reprogram the pump to deliver the contents of the bag. The amount to reprogram is an estimation and can add up to approximately 30 min of infusion time to an outpatient oncology infusion session.

[0007] Flushing: After the bag is emptied, it is common that the line will run dry (fill with air) up to the pump’s onboard air sensor. After the pump senses the air, it alerts the clinician that the infusion is complete. However, drug is still left in the line connecting the bag to the patient below the pump. In certain instances, this volume of drug is clinically significant and requires additional steps by the clinical team to flush with saline at the correct rate. These extra steps can add up to approximately 10 min of infusion time to an outpatient oncology infusion session.

[0008] Combined, these inefficiencies represent up to approximately 55 min of potential time wasted during a chemotherapy infusion.

[0009] U.S. Patent No. 10,413,662 to Yeh et al. is directed to a priming apparatus and method to remove air from within tubing coupled to a medical fluid reservoir.SUMMARY OF THE INVENTION

[0010] In one aspect or embodiment, a priming device includes a body, a connection member configured to mate with a corresponding connector of a closed system transfer device, an elastomeric member connected to the body and moveable relative to the body between a first position where the elastomeric member and the body define a first volume and a second position where the elastomeric member and the body define a second volume, where the second volume is larger than the first volume, with the first and second volumes in fluid communication with the connection member, and a handle connected to the elastomeric member and configured to move the elastomeric member between the first and second positions.

[0011] In a further aspect or embodiment, a delivery adapter includes a housing, a spike adapter connected to the housing, with the spike adapter defining an input flow path and an output flow path, a connection member configured to mate with a corresponding connector of a closed system transfer device, with the connection member in fluid communication with the input flow path, a priming bulb in fluid communication with the input flow path, with the priming bulb including a valve arrangement configured to allow flow from the connection member to the spike and prevent flow from the spike to the connection member, a flush reservoir in fluid communication with the output flow path, an output connector in fluid communication with the flush reservoir and the output flow path, with the output connector including a check valve to prevent fluid flow from the output connector to the flush reservoir, a hydrophilic membrane positioned between the output flow path and the output connector, and a valve member positioned between the output flow path and the flush reservoir and between the output flow path and the hydrophilic membrane. The valve member moveable between a first position where the output flow path is in fluid communication with the flush reservoir and a second position where the output flow path is in fluid communication with the hydrophilic member and the output connector.

[0012] In a further aspect or embodiment, an infusion delivery device includes a drug reservoir comprising an air portion and a fluid portion, a flush reservoir in fluid communication with the drug reservoir via a channel, with the channel including a clamp configured to isolate the flush reservoir from the drug reservoir, a drip chamber spike adapter in fluid communication with the drug reservoir, with the flush reservoir in fluid communication with the drip chamber spike adapter via a check valve configured to only allow flow from the flush reservoir to the drip chamber spike adapter, a float ball and receiving cone positioned between the drug reservoir and the drip chamber spike adapter, and an input port in fluid communication with the drug reservoir and configured to allow fluid flow into the drug reservoir via the input port.

[0013] In a further aspect or embodiment, an infusion delivery device includes a drug reservoir with a predetermined volume of fluid, a flush reservoir with a predetermine volume of fluid, a drip chamber spike adapter in fluid communication with the drug reservoir, with the flush reservoir in fluid communication with the drip chamber spike adapter via a check valve configured to only allow flow from the flush reservoir to the drip chamber spike adapter, a float ball and receiving cone positioned between the drug reservoir and the drip chamber spike adapter, an input port in fluid communication with the drug reservoir and configured to allowfluid flow into the drug reservoir via the input port, and a priming bulb in fluid communication with the input port and the drug reservoir.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of aspects of the disclosure taken in conjunction with the accompanying drawings, wherein:

[0015] FIG. 1 is a perspective view of a priming device according to one aspect or embodiment of the present application;

[0016] FIG. 2 is a perspective view of the device of FIG. 1;

[0017] FIG. 3 is a cross-sectional view of the device of FIG. 1, showing a pre-use position of the device;

[0018] FIG. 4 is a cross-sectional view of the device of FIG. 1, showing a transition position of the device;

[0019] FIG. 5 is a cross-sectional view of the device of FIG. 1, showing a use position of the device;

[0020] FIG. 6 is a perspective view a delivery adapter according to one aspect or embodiment of the present application;

[0021] FIG. 7 is a perspective view of the adapter of FIG. 6;

[0022] FIG. 8 is a front view of the adapter of FIG. 6;

[0023] FIG. 9 is a rear view of the adapter of FIG. 6;

[0024] FIG. 10 is a cross-sectional view of the adapter of FIG. 6;

[0025] FIG. 11 is a partial cross-sectional view of the adapter of FIG. 6;

[0026] FIG. 12 is a side view of a housing of the adapter of FIG. 6;

[0027] FIG. 13 is a perspective view of a housing of the adapter of FIG. 6;

[0028] FIG. 14 is a rear view of a housing of the adapter of FIG. 6;

[0029] FIG. 15 is a perspective view of a housing of the adapter of FIG. 6;

[0030] FIG. 16 is a perspective view of a housing of the adapter of FIG. 6;

[0031] FIG. 17 is a bottom view of a housing of the adapter of FIG. 6;

[0032] FIG. 18 is a cross-sectional view of the adapter of FIG. 6, showing an unfilled position of a reservoir;

[0033] FIG. 19 is a cross-sectional view of the adapter of FIG. 6, showing a filled position of a reservoir;

[0034] FIG. 20 is a front view of the adapter of FIG. 6, showing a first position of a valve;

[0035] FIG. 21 is a partial cross-sectional view of the adapter of FIG. 6, showing a fluid path and first position of a valve;

[0036] FIG. 22 is a front view of the adapter of FIG. 6, showing a second position of a valve;

[0037] FIG. 23 is a partial cross-sectional view of the adapter of FIG. 6, showing a fluid path and second position of a valve;

[0038] FIG. 24 is a partial cross-sectional view of the adapter of FIG. 6, showing an anti-run dry device;

[0039] FIG. 25 is a partial perspective view of the adapter of FIG. 6, showing an anti-run dry device;

[0040] FIG. 26 is a front view of the adapter of FIG. 6, showing a first step in using the adapter according to one aspect or embodiment of the present application;

[0041] FIG. 27 is a perspective view of the adapter of FIG. 6, showing a first step in using the adapter according to one aspect or embodiment of the present application;

[0042] FIG. 28 is a cross-sectional view of the adapter of FIG. 6, showing a first step in using the adapter according to one aspect or embodiment of the present application;

[0043] FIG. 29 is a front view of the adapter of FIG. 6, showing a second step in using the adapter according to one aspect or embodiment of the present application;

[0044] FIG. 30 is a partial cross-sectional view of the adapter of FIG. 6, showing a second step in using the adapter according to one aspect or embodiment of the present application;

[0045] FIG. 31 is a front view of the adapter of FIG. 6, showing a third step in using the adapter according to one aspect or embodiment of the present application;

[0046] FIG. 32 is a cross-sectional view of the adapter of FIG. 6, showing a third step in using the adapter according to one aspect or embodiment of the present application;

[0047] FIG. 33 is a schematic view showing components and fluid path of the adapter of FIG. 6 according to one aspect or embodiment of the present application;

[0048] FIG. 34 is a partial cross-sectional view of the adapter of FIG. 6, showing a flush valving fluid path;

[0049] FIG. 35 is a partial cross-sectional view of an anti-dry device according to a further aspect or embodiment of the present application;

[0050] FIG. 36 is a front view of an infusion delivery device according to one aspect or embodiment of the present application;

[0051] FIG. 37 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application;

[0052] FIG. 38 is a front view of the device of FIG. 37;

[0053] FIG. 39 is a perspective view of a flush chamber housing of the device of FIG. 37;

[0054] FIG. 40 is a partial front view of the device of FIG. 37;

[0055] FIG. 41 is a partial side view of the device of FIG. 37;

[0056] FIG. 42 is a side view of the device of FIG. 37;

[0057] FIG. 43 is a front view of the device of FIG. 37;

[0058] FIG. 44 is a top view of the device of FIG. 37;

[0059] FIG. 45 is a side view of the device of FIG. 37, showing a graduation marks or indicators on a reservoir;

[0060] FIG. 46 is a perspective view of the device of FIG. 37, showing a first step of using the device;

[0061] FIG. 47 is a perspective view of the device of FIG. 37, showing a second step of using the device;

[0062] FIG. 48 is a perspective view of the device of FIG. 37, showing a third step of using the device;

[0063] FIG. 49 is a perspective view of the device of FIG. 37, showing a fourth step of using the device;

[0064] FIG. 50 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application;

[0065] FIG. 51 is a front view of an infusion delivery device according to a further aspect or embodiment of the present application;

[0066] FIG. 52 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application;

[0067] FIG. 53 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application;

[0068] FIG. 54 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application;

[0069] FIG. 55 is a front view of a delivery bottle according to one aspect or embodimemt of the present application;

[0070] FIG. 56 is a side view of the delivery bottle of FIG. 55;

[0071] FIG. 57 is a partial cross-sectional view of the delivery bottle of FIG. 55;

[0072] FIG. 58 is a perspective view of a bypass plunger of the delivery bottle of FIG. 55;

[0073] FIG. 59 is a cross-sectional view of the bypass plunger of FIG. 58;

[0074] FIG. 60 is a cross-sectional view of the delivery bottle of FIG. 55, showing a pre-use position;

[0075] FIG. 61 is a cross-sectional view of the delivery bottle of FIG. 55, showing a use position;

[0076] FIG. 62 is a cross-sectional view of the delivery bottle of FIG. 55, showing a pre-use position;

[0077] FIG. 63 is a cross-sectional view of the delivery bottle of FIG. 55, showing a use position;

[0078] FIG. 64 is an enlarged cross-sectional view of the delivery bottle shown in FIG. 63;

[0079] FIG. 65 is a cross-sectional view of the delivery bottle of FIG. 55, showing a use position;

[0080] FIG. 66 is an enlarged cross-sectional view of the delivery bottle shown in FIG. 65; and

[0081] FIG. 67 is a partial front view of the delivery bottle shown in FIG. 55.

[0082] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary aspects of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.DETAILED DESCRIPTION

[0083] The following description is provided to enable those skilled in the art to make and use the described aspects contemplated for carrying out the invention. Various modifications, equivalents, variations, and alternatives, however, will remain readily apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and alternatives are intended to fall within the spirit and scope of the present invention.

[0084] For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary aspects of the invention. Hence, specific dimensions and other physical characteristics related to the aspects disclosed herein are not to be considered as limiting.

[0085] Unless otherwise indicated, all ranges or ratios disclosed herein are to be understood to encompass the beginning and ending values and any and all subranges or subratios subsumed therein. For example, a stated range or ratio of “1 to 10” should be considered to include any and all subranges or subratios between (and inclusive of) the minimum value of 1 and the maximum value of 10; that is, all subranges or subratios beginning with a minimum value of 1 or more and ending with a maximum value of 10 or less.

[0086] The terms “first”, “second”, and the like are not intended to refer to any particular order or chronology, but refer to different conditions, properties, or elements.

[0087] As used herein, “at least one of’ is synonymous with “one or more of’. For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, “at least one of A, B, and C” includes one or more of A alone; or one or more of B alone; or one or more of C alone; or one or more of A and one or more of B; or one or more of A and one or more of C; or one or more of B and one or more of C; or one or more of all of A, B, and C.

[0088] Referring to FIGS. 1-5, in one aspect or embodiment of the present application, a priming device 10 includes a body, a connection member 12 configured to mate with a corresponding connector of a closed system transfer device, an elastomeric member 14 connected to the body and moveable relative to the body between a first position where the elastomeric member 14 and the body define a first volume and a second position where the elastomeric member 14 and the body define a second volume, where the second volume is larger than the first volume, with the first and second volumes in fluid communication with the connection member, and a handle 16 connected to the elastomeric member 14 and configured to move the elastomeric member 14 between the first and second positions.

[0089] A healthcare worker or patient attaches the connection member 12 to a closed system transfer device, such as the injector of the BD PhaSeal Optima System commercially available from Becton, Dickinson and Company, which is installed on the end of an IV line. A healthcare user pulls the handle 16 to the extended position. The handle 16 clicks in place and stays extended. This deflects the domed elastomeric member 14 which stores energy in its deflected shape and forces a vacuum within the domed chamber. The vacuum within the domed chamber pulls all air from the IV line. The domed chamber and elastomeric member 14 can be sized in such a way as to hold the air volume of a specific IV set. When the IV line is fully primed, the priming device 10 is removed and discarded.

[0090] Referring to FIGS. 6-35, according to one aspect or embodiment of the present application, a delivery adapter 100 includes a housing 102, a spike adapter 104 connected tothe housing 102, with the spike adapter 104 defining an input flow path 106 and an output flow path 108, a connection member 110 configured to mate with a corresponding connector of a closed system transfer device, with the connection member 110 in fluid communication with the input flow path 106, a priming bulb 112 in fluid communication with the input flow path 106, with the priming bulb 112 including a valve arrangement 114 configured to allow flow from the connection member 110 to the spike 104 and prevent flow from the spike 104 to the connection member 110, a flush reservoir 116 in fluid communication with the output flow path 108, an output connector 118 in fluid communication with the flush reservoir 116 and the output flow path 108, with the output connector 118 including a check valve 120 to prevent fluid flow from the output connector 118 to the flush reservoir 116, a hydrophilic membrane 122 positioned between the output flow path 108 and the output connector 118, and a valve member 124 positioned between the output flow path 108 and the flush reservoir 116 and between the output flow path 108 and the hydrophilic membrane 122. The valve member 124 moveable between a first position where the output flow path 108 is in fluid communication with the flush reservoir 116 and a second position where the output flow path 108 is in fluid communication with the hydrophilic member 122 and the output connector 118.

[0091] Referring to FIGS. 24 and 25, the hydrophilic member 122 forms an anti-run dry device that directs the fluid through the hydrophilic membrane 122. After the membrane 122 has been wetted out, it requires a large pressure to pull the fluid through the micropores. This pressure is larger than the gravimetric head height of the infusion set or that which is supplied by the pump. When the bag runs out of fluid, air is pulled into the delivery adapter 100 and is unable to be pulled through the membrane 122 causing a vacuum to be applied onto the surface of the check valve 120.

[0092] Referring to FIGS. 26-28, in a first step of using the delivery adapter 100, a healthcare worker connects the delivery adapter 100 to a bag filled with normal saline and sets the selector switch 124 to a valve position. The fluid path from the bag is directed to the flush reservoir 116 as shown.

[0093] Referring to FIG. 29 and 30, in a second step, a healthcare worker connects a syringe and closed system transfer device, such as the injector of the BD PhaSeal Optima System commercially available from Becton, Dickinson and Company, to the connector 110 and injects the concentrated drug into the bag. The healthcare worker mixes normally. The fluid path is as shown in FIG. 30. The valve arrangement 114, such as check valves, allow flow in the direction shown in FIG. 30.

[0094] Referring to FIGS. 31 and 32, in a third step accomplished in pharmacy or at the point of administration, a healthcare worker connects the IV-line injector to the integrated CSTD connector 110. The healthcare worker primes the drip chamber normally creating Hl as shown in FIG. 31. The hydrophilic membrane 122 may be wetted which would not allow the air from the drip chamber to travel into the bag. If this is the case, an alternative method of priming the drip chamber or an alternative anti-run dry approach may need to be utilized. Because of the head height difference (H1-H2), the IV line will automatically prime with fluid from the saline bag until H1-H2 is equivalent to the sum of all pressure losses in the line, leaving a small volume of air at the end of the IV line. At his point, the healthcare worker presses the priming button 112 which forces all fluid and gas through the valve arrangement 114. The restoring force of the priming button 112 pulls a vacuum and draws the fluid through the valve arrangement 114. This cycle is repeated until all air is removed from the IV line and the IV line is fully primed with drug. The healthcare worker disconnects the CSTD injector and the drug is now ready to be administered. These steps can be repeated during administration if, for any reason, air is found to be within the IV line.

[0095] Referring to FIGS. 33 and 34, the pump will first draw fluid from the drug reservoir due to the presence of the check valve 120. The check valve 120 prevents flow from the flush reservoir 116 using one or both of the following methods: (1) the head height of the drug reservoir is higher than the flush reservoir 116, keeping the check valve 120 closed; or (2) the check valve 120 could be provided with a minimum cracking pressure that would need to be overcome before it would allow flow. This cracking pressure could be greater than the head height of the flush reservoir 116 but less than what could be overcome by the pump. When the drug reservoir is empty, the anti-run dry device will engage as described previously resulting in a vacuum on check valve. This will cause the pump to pull fluid from the flush reservoir 116. The flush reservoir 116 volume will be sized to approximately match the tubing priming volume so that the drug in line will continue to infuse. The infusion will be complete when either of the following two scenarios occur: (1) the pump reaches the VTBI programed limit; or (2) the flush pack is empty causing an upstream occlusion alarm on the pump, which means all drug and flush fluid have been administered.

[0096] Referring to FIGS. 35 and 36, according to a further aspect or embodiment, an infusion delivery device 200 includes a drug reservoir 202 comprising an air portion 204 and a fluid portion 206, a flush reservoir 208 in fluid communication with the drug reservoir 202 via a channel 210, with the channel 210 including a clamp 212 configured to isolate the flush reservoir 208 from the drug reservoir 202, a drip chamber spike adapter 214 in fluidcommunication with the drug reservoir 202, with the flush reservoir 208 in fluid communication with the drip chamber spike adapter 214 via a check valve 216 configured to only allow flow from the flush reservoir 208 to the drip chamber spike adapter 214, a float ball 218 and receiving cone 220 positioned between the drug reservoir 202 and the drip chamber spike adapter 214, and an input port 222 in fluid communication with the drug reservoir 202 and configured to allow fluid flow into the drug reservoir 202 via the input port 222.

[0097] The drug reservoir 202 may be a flexible bladder having a portion intended for excess air and a portion intended for drug with volumetric graduation marks. A ring may be provided which holds the drug portion of the bladder into a cylindrical shape with a consistent cross section. The float ball 218 is included within the bladder and the receiving cone 220 is included within the base of the bladder. The drip chamber spike adapter 214 is included as the fluid exit from the bladder and the interface to the IV set. The flush reservoir 208 is hydraulically connected to the spike adapter 214 via the check valve 216 (such as a duckbill valve) which remains closed under hydraulic pressure on the outlet side of the valve 216 and only allows flow through the valve 216 if some amount of vacuum is applied to the outlet or a higher- pressure source is applied to the inlet side of the check valve 216. The check valve 216 is positioned such that the inlet to the valve 216 is hydraulically coupled to the flush reservoir 208 and the outlet to the valve 216 is hydraulically coupled to the outlet of the bladder.

[0098] The bladder is provided either filled with a base solution of a prescribed amount or empty. If empty the pharmacist would first fill the bladder with a non-hazardous base solution such as saline for the intended dose (such as 500mL). As the bladder fills both portions are filled, and all the air is allowed to fill into the drug reservoir. The pharmacist would then close the clamp 212 ensuring that the flush reservoir 208 is isolated from the drug reservoir 202. The flush reservoir 208 contains approximately the same volume as the tubing to be used to infuse the drug (such as 30mL). The pharmacists can optionally attach the IV line to the spike port 214 but does not prime the line. Instead, the pharmacist clamps the IV line. The pharmacists then prepares the concentrated drug, and withdrawals from the drug source (such as a vial) into a syringe the desired dose, then injects the desired dose into the bladder via the inlet port. The drug is allowed to mix with the contents of the bladder resulting in the diluted drug mixture intended to be infused. The pharmacist then connects the end of the IV line to the inlet port. The head height of the drug within the bladder is sufficient to enable the drug to flow through the IV line and the air from the IV line to be emptied into the bladder and rise to the top of the drug reservoir. If the inlet port is a closed system transfer device or connector, the IV line can be safely disconnected from the inlet port, and the line is primed with the drug. Theadministration nurse hangs the bag on the chair- side IV pole and notes the graduation mark corresponding to the liquid level of the bag. This represents the precise volume to be infused, and the nurse programs the pump to deliver this volume over the prescribed time (such as 1 hour). The float ball 218 is resting on the top of the fluid surface. As the fluid contents are emptied, the float ball 218 lowers in height until it rests against the receiving cone 220, and at which point it forms a liquid seal with the cone 220. The infusion pump continues to draw fluid and develops sufficient pressure to open the check valve 216. The contents of the flushing reservoir 208 are then allowed to be delivered, resulting in the drug in the line being completely delivered to the patient. As the bag is emptied, the pump either reaches the end of the volume to be infused or senses an upstream occlusion and alerts the clinical staff that the infusion is complete.

[0099] The infusion delivery device 200 of FIGS. 35 and 36 advantageously provides: a way to safely prime the IV line with the drug to allow the providers to avoid delays associated with waiting for the primed saline to be infused; a way to measure the final volume to be infused to allow the administration nurse to correctly program the pump with an accurate volume, over the intended duration, ensuring that the rate is correct, and avoiding delays associated with bag- overfill and reprogramming; and a way to automatically flush the IV line of the drug with a base solution, thereby ensuring that the entire dose has been delivered, and avoiding any delays associated with the secondary tubing flushing step.

[0100] Referring to FIGS. 37-54, according to a further aspect or embodiment of the present application, an infusion delivery device 300 includes a drug reservoir 302 with a predetermined volume of fluid, a flush reservoir 304 with a predetermine volume of fluid, a drip chamber spike adapter 306 in fluid communication with the drug reservoir 302, with the flush reservoir 304 in fluid communication with the drip chamber spike adapter 306 via a check valve 308 configured to only allow flow from the flush reservoir 304 to the drip chamber spike adapter 306, a float ball 310 and receiving cone 312 positioned between the drug reservoir 302 and the drip chamber spike adapter 306, an input port 314 in fluid communication with the drug reservoir 302 and configured to allow fluid flow into the drug reservoir 302 via the input port 314, and a priming bulb 316 in fluid communication with the input port 314 and the drug reservoir 302.

[0101] In one aspect or embodiment, the flush reservoir 304 is formed by a semi- spherical shell 318 and a thin film welded to the semi- spherical shell. The flush reservoir 304 is in fluid communication with the drip chamber spike adapter 306 via a tube 320 with a clamp 322 controlling flow, although other suitable arrangements may be utilized. As shown in FIG. 45,the drug reservoir 302 may include graduation marks or other marker to indicate a volume measurement.

[0102] Referring to FIGS. 55-67, a delivery bottle 400 according to one aspect or embodiment of the present application is shown, which may be utilized in connection with the delivery adapter 100 and the device 300 discussed above. The delivery bottle 400 includes a cylinder 402 defining an inner volume 404 that receives an inner sleeve 404 and a bypass plunger 406. The delivery bottle 400 is configured enable an automatic flushing of the drug in-line within an architecture intended for precise measurement of the volume to be infused.

[0103] Referring to FIG. 59, the bypass plunger 406 includes a body 408 made from rigid plastic, an outer seal 410 intended to prevent fluid from passing between the plunger 406 and the outer cylinder 402, an inner seal 412 that includes a one-way valve 414 that requires a certain minimum pressure to open (“cracking pressure”), and a hydrophobic membrane 416, which allows air to bypass the plunger 406.

[0104] Referring to FIGS. 60 and 61, the inner sleeve 404 includes a thin plastic film capable of compressing and stretching to fill the inner space of the cylinder 402, although other suitable arrangements may be utilized.

[0105] Referring to FIGS. 62-64, the delivery bottle 400 is provided pre-filled with a diluent (e.g., saline). A volume intended for flushing is included in the enclosed space above the bypass plunger 406. The one-way valve 414 prevents the flush fluid from mixing with the drug fluid. Concentrated drug is injected and mixed normally via the integrated CSTD port 110, 314. If air enters the drug chamber it is allowed to bypass the plunger 406 through the hydrophobic membrane 416 and reside within the flush chamber above.

[0106] Referring to FIG. 65, as the drug is delivered the plunger 406 is pulled down. The seal between the outer seal 410 and the cylindrical wall is intended to be such that friction is not a significant source of resistance to the plunger’s motion. The inner sleeve 404 is allowed to expand / contract to equalize pressure by an air vent included in the cap. The inner sleeve 404 ensures that the flush solution or potentially hazardous air (vapor) is contained within the cylinder 402.

[0107] Referring to FIG. 66, when all drug has been delivered, the bypass plunger 406 will fully seat on the bottom of the cylinder 402. This will allow a vacuum to form from the head height of the IV line or the pump. This vacuum will overcome the cracking pressure of the oneway valve 414, allowing the flush solution to flow. The cracking pressure of the one-way valve 414 is greater than the friction resistance of the outer seal 410 against the cylinder wall. Thevacuum formed, which pulls the inner seal 412 against the corresponding seating geometry in the outer cylinder 402, ensures that air is not pulled through the hydrophobic membrane 416.

[0108] Referring to FIG. 67, in some aspects or embodiments of the present application, the bypass plunger 406 includes a reference line 418 for healthcare workers to measure the volume contents of the cylinder. The reference line 418 is included in the outer seal 410.

[0109] While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims. To the extent possible, one or more features of any aspect or embodiment discussed above can be combined with one or more features of any other aspect or embodiment.

Claims

THE INVENTION CLAIMED IS:

1. A priming device comprising: a body; a connection member configured to mate with a corresponding connector of a closed system transfer device; an elastomeric member connected to the body and moveable relative to the body between a first position where the elastomeric member and the body define a first volume and a second position where the elastomeric member and the body define a second volume, wherein the second volume is larger than the first volume, the first and second volumes are in fluid communication with the connection member; and a handle connected to the elastomeric member and configured to move the elastomeric member between the first and second positions.

2. A delivery adapter comprising: a housing; a spike adapter connected to the housing, the spike adapter defining an input flow path and an output flow path; a connection member configured to mate with a corresponding connector of a closed system transfer device, the connection member in fluid communication with the input flow path; a priming bulb in fluid communication with the input flow path, the priming bulb comprising a valve arrangement configured to allow flow from the connection member to the spike and prevent flow from the spike to the connection member; a flush reservoir in fluid communication with the output flow path; an output connector in fluid communication with the flush reservoir and the output flow path, wherein the output connector includes a check valve to prevent fluid flow from the output connector to the flush reservoir; a hydrophilic membrane positioned between the output flow path and the output connector; and a valve member positioned between the output flow path and the flush reservoir and between the output flow path and the hydrophilic membrane, the valve member moveable between a first position where the output flow path is in fluid communication with the flushreservoir and a second position where the output flow path is in fluid communication with the hydrophilic member and the output connector.

3. An infusion delivery device comprising: a drug reservoir comprising an air portion and a fluid portion; a flush reservoir in fluid communication with the drug reservoir via a channel, the channel comprising a clamp configured to isolate the flush reservoir from the drug reservoir; a drip chamber spike adapter in fluid communication with the drug reservoir, the flush reservoir is in fluid communication with the drip chamber spike adapter via a check valve configured to only allow flow from the flush reservoir to the drip chamber spike adapter; a float ball and receiving cone positioned between the drug reservoir and the drip chamber spike adapter; and an input port in fluid communication with the drug reservoir and configured to allow fluid flow into the drug reservoir via the input port.

4. An infusion delivery device comprising: a drug reservoir with a predetermined volume of fluid; a flush reservoir with a predetermine volume of fluid; a drip chamber spike adapter in fluid communication with the drug reservoir, the flush reservoir is in fluid communication with the drip chamber spike adapter via a check valve configured to only allow flow from the flush reservoir to the drip chamber spike adapter; a float ball and receiving cone positioned between the drug reservoir and the drip chamber spike adapter; an input port in fluid communication with the drug reservoir and configured to allow fluid flow into the drug reservoir via the input port; and a priming bulb in fluid communication with the input port and the drug reservoir.

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