Infusion line priming adapter

Abstract

The priming device includes a body, a connecting member configured to mate with a corresponding connector of a closed system delivery device, and a handle connected to the body and movable relative to the body between a first position in which the elastomer member and the body define a first volume and a second position in which the elastomer member and the body define a second volume, the second volume being larger than the first volume, the first and second volumes being in fluid communication with the connecting member, and connected to the elastomer member and configured to move the elastomer member between the first and second positions.

Description

[[Technical Field]]

[0001] The present disclosure generally relates to concepts for priming an infusion line. [[Background Art]]

[0002] This application claims priority to U.S. Provisional Application No. 63 / 581,759, filed September 11, 2023, entitled "Priming Adapter for Infusion Line", the disclosure of which is incorporated herein by reference in its entirety.

[0003] Healthcare providers who reconstitute, transport, and administer hazardous drugs such as cancer treatments may expose themselves to the risk of exposure to these drugs and pose hazards to the healthcare environment. Unintentional chemotherapy exposure can affect the nervous system, damage the reproductive system, and increase the risk of developing blood cancer in the future. Some drugs must be dissolved or diluted before they can be administered, which involves transferring solvent from one container via a needle into a sealed vial containing the drug in powder or liquid form. Drugs can be inadvertently released into the atmosphere in gaseous form or by aerosolization during withdrawal of the needle from the vial and while the needle is within the vial if there is a pressure difference between the interior of the vial and the surrounding atmosphere. To reduce the risk of exposure of healthcare providers to toxic drugs, delivery of these drugs is achieved by utilizing closed system delivery devices or systems.

[0004] Three challenges have been observed that cause significant inefficiency during administration of chemotherapy by intravenous (IV) infusion. Given that these procedures occur in an outpatient oncology setting, the consequences of delays can have a significant impact on patient throughput through the facility and patients' personal schedules.

[0005] Infusion of primed saline: Because chemotherapy drugs are dangerous, IV lines are usually primed with a base solution (such as saline) before being connected to a bag containing the drugs, or before the drugs are injected into the bag of base solution via a syringe. Given that IV lines can often contain up to 30 mL of fluid, it can take up to approximately 15 minutes at a given rate (e.g., 120 mL / hour) for the saline in the line to be injected into the patient and for the drugs to first enter the patient.

[0006] Bag Overfill: Measuring the exact volume of the bag to be infused after a pharmacist has prepared the medication can be challenging. Often, pharmacists receive pre-filled saline bags with some inherent variability (approximately +10%) in their volume and add an additional volume (approximately 10-100 mL) when infusing the medication to be injected. As a result, the nurse administering the medication has the exact amount of medication diluted in a somewhat inaccurate amount of saline. In the industry, this is commonly referred to as a "bag overfill" and is observed when the volume displacement pump has finished delivering the volume intended to be infused, but the clinician observes that there is still fluid in the bag containing some of the medication intended to be infused. Therefore, the clinician must reprogram the pump to deliver the contents of the bag. The amount to reprogram is an estimate and can add approximately 30 minutes of infusion time to an outpatient oncological infusion session.

[0007] Flushing: After emptying the bag, it is common for the line to dry out (fill with air) up to the pump's onboard air sensor. When the pump detects air, it alerts the clinician that the infusion is complete. However, some medication remains in the line connecting the bag below the pump to the patient. In certain cases, this amount of medication is clinically significant and requires an additional step by the clinical team to flush with saline at the correct rate. These additional steps can add approximately 10 minutes of infusion time to an outpatient oncological infusion session.

[0008] Combined, these inefficiencies represent up to approximately 55 minutes of potentially wasted time during chemotherapy infusions.

[0009] Yeh et al.'s Patent Document 1 relates to a priming device and method for removing air from a tube coupled to a medical fluid reservoir. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] U.S. Patent No. 10,413,662 [Overview of the project] [Means for solving the problem]

[0011] In one aspect or embodiment, the priming device includes a body, a connecting member configured to mate with a corresponding connector of a closed system delivery device, and a handle connected to the body and movable relative to the body between a first position in which the elastomer member and the body define a first volume and a second position in which the elastomer member and the body define a second volume, the second volume being larger than the first volume, the first and second volumes being in fluid communication with the connecting member, and connected to the elastomer member and configured to move the elastomer member between the first and second positions.

[0012] In further embodiments or designs, the delivery adapter includes a housing; a spike adapter connected to the housing, defining an input channel and an output channel; a connecting member configured to mate with a corresponding connector of a closed system delivery device, the connecting member having fluid communication with the input channel; a priming valve having fluid communication with the input channel, the priming valve including a valve configuration configured to allow flow from the connecting member to the spike and prevent flow from the spike to the connecting member; a flash reservoir having fluid communication with the output channel; an output connector having fluid communication with the flash reservoir and the output channel, the output connector including a check valve preventing fluid flow from the output connector to the flash reservoir; a hydrophilic membrane disposed between the output channel and the output connector; and a valve member disposed between the output channel and the hydrophilic membrane, and between the output channel and the hydrophilic membrane. The valve member is movable between a first position in which the output channel has fluid communication with the flash reservoir and a second position in which the output channel has fluid communication with the hydrophilic member and the output connector.

[0013] In further embodiments or designs, the infusion delivery device includes a drug reservoir comprising an air portion and a fluid portion; a flush reservoir fluid-communicating with the drug reservoir via a channel including a clamp configured to separate the flush reservoir from the drug reservoir; a drip chamber spike adapter fluid-communicating with the drug reservoir; the flush reservoir fluid-communicating with the drip chamber spike adapter via a check valve configured to allow flow only from the flush reservoir to the drip chamber spike adapter; a float ball and a receiving cone positioned between the drug reservoir and the drip chamber spike adapter; and an input port fluid-communicating with the drug reservoir and configured to allow the inflow of fluid into the drug reservoir via the input port.

[0014] In further embodiments or designs, the infusion delivery device includes a drug reservoir having a predetermined volume of fluid, a flush reservoir having a predetermined volume of fluid, a drip chamber spike adapter fluid-communicating with the drug reservoir, the flush reservoir and the drip chamber spike adapter fluid-communicating via a check valve configured to allow flow only from the flush reservoir to the drip chamber spike adapter, a float ball and a receiving cone positioned between the drug reservoir and the drip chamber spike adapter, an input port fluid-communicating with the drug reservoir and configured to allow fluid to flow into the drug reservoir via the input port, and a priming valve fluid-communicating with the input port and the drug reservoir.

[0015] The features and other advantages of this disclosure, as well as the methods for achieving them, will become clearer and the disclosure itself will be better understood by referring to the following description of embodiments of this disclosure in conjunction with the accompanying drawings.

[0016] Corresponding reference numerals indicate corresponding parts through some of the figures. The examples presented herein illustrate exemplary embodiments of the disclosure and should not be construed as limiting the scope of the disclosure in any way. [Brief explanation of the drawing]

[0017] [Figure 1] Figure 1 is a perspective view of a priming device according to one aspect or embodiment of this application. [Figure 2] Figure 2 is a perspective view of the device shown in Figure 1. [Figure 3] Figure 3 is a cross-sectional view of the device shown in Figure 1, indicating the device's position before use. [Figure 4] Figure 4 is a cross-sectional view of the device in Figure 1, showing the transition position of the device. [Figure 5] Figure 5 is a cross-sectional view of the device shown in Figure 1, illustrating the device's usage location. [Figure 6]Figure 6 is a perspective view of a delivery adapter according to one aspect or embodiment of the present application. [Figure 7] Figure 7 is a perspective view of the adapter of Figure 6. [Figure 8] Figure 8 is a front view of the adapter of Figure 6. [Figure 9] Figure 9 is a rear view of the adapter of Figure 6. [Figure 10] Figure 10 is a cross-sectional view of the adapter of Figure 6. [Figure 11] Figure 11 is a partial cross-sectional view of the adapter of Figure 6. [Figure 12] Figure 12 is a side view of a housing of the adapter of Figure 6. [Figure 13] Figure 13 is a perspective view of the housing of the adapter of Figure 6. [Figure 14] Figure 14 is a rear view of the housing of the adapter of Figure 6. [Figure 15] Figure 15 is a perspective view of the housing of the adapter of Figure 6. [Figure 16] Figure 16 is a perspective view of the housing of the adapter of Figure 6. [Figure 17] Figure 17 is a bottom view of the housing of the adapter of Figure 6. [Figure 18] Figure 18 is a cross-sectional view of the adapter of Figure 6, showing an unfilled position of a reservoir. [Figure 19] Figure 19 is a cross-sectional view of the adapter of Figure 6, showing a filled position of the reservoir. [Figure 20] Figure 20 is a front view of the adapter of Figure 6, showing a first position of a valve. [Figure 21] Figure 21 is a partial cross-sectional view of the adapter of Figure 6, showing a fluid path of the valve and the first position of the valve. [Figure 22] Figure 22 is a front view of the adapter of Figure 6, showing a second position of the valve. [Figure 23] Figure 23 is a partial cross-sectional view of the adapter of Figure 6, showing a fluid path of the valve and the first position of the valve. [Figure 24]Figure 24 is a partial cross-sectional view of the adapter in Figure 6, showing the dry-running prevention device. [Figure 25] Figure 25 is a partial perspective view of the adapter in Figure 6, showing the dry-running prevention device. [Figure 26] Figure 26 is a front view of the adapter of Figure 6, illustrating the first step in using the adapter according to one aspect or embodiment of this application. [Figure 27] Figure 27 is a perspective view of the adapter of Figure 6, showing the first step in using the adapter according to one aspect or embodiment of this application. [Figure 28] Figure 28 is a front view of the adapter of Figure 6, illustrating the first step in using the adapter according to one aspect or embodiment of this application. [Figure 29] Figure 29 is a front view of the adapter of Figure 6, illustrating a second step in the use of the adapter according to one aspect or embodiment of this application. [Figure 30] Figure 30 is a front view of the adapter of Figure 6, illustrating a second step in the use of the adapter according to one aspect or embodiment of this application. [Figure 31] Figure 31 is a front view of the adapter of Figure 6, illustrating a third step in the use of the adapter according to one aspect or embodiment of this application. [Figure 32] Figure 32 is a front view of the adapter of Figure 6, illustrating a third step in the use of the adapter according to one aspect or embodiment of this application. [Figure 33] Figure 33 is a schematic diagram showing the components and fluid paths of the adapter of Figure 6 according to one aspect or embodiment of this application. [Figure 34] Figure 34 is a partial cross-sectional view of the adapter in Figure 6, showing the fluid path of the flush valve. [Figure 35] Figure 35 is a partial cross-sectional view of a drying prevention device according to a further aspect or embodiment of the present application. [Figure 36] Figure 36 is a front view of an infusion delivery device according to one aspect or embodiment of the present application. [Figure 37]Figure 37 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application. [Figure 38] Figure 38 is a front view of the device shown in Figure 37. [Figure 39] Figure 39 is a perspective view of the flash chamber housing of the device shown in Figure 37. [Figure 40] Figure 40 is a partial front view of the device shown in Figure 37. [Figure 41] Figure 41 is a partial side view of the device shown in Figure 37. [Figure 42] Figure 42 is a side view of the device shown in Figure 37. [Figure 43] Figure 43 is a front view of the device shown in Figure 37. [Figure 44] Figure 44 is a top view of the device shown in Figure 37. [Figure 45] Figure 45 is a side view of the device shown in Figure 37, showing scale marks or indicators on the reservoir. [Figure 46] Figure 46 is a perspective view of the device shown in Figure 37, illustrating the first step in using the device. [Figure 47] Figure 47 is a perspective view of the device in Figure 37, showing the second step in using the device. [Figure 48] Figure 48 is a perspective view of the device shown in Figure 37, illustrating the third step in using the device. [Figure 49] Figure 49 is a perspective view of the device shown in Figure 37, illustrating the fourth step in using the device. [Figure 50] Figure 50 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application. [Figure 51] Figure 51 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application. [Figure 52] Figure 52 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application. [Figure 53] Figure 53 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application. [Figure 54] Figure 54 is a perspective view of an infusion delivery device according to a further aspect or embodiment of the present application. [Figure 55] Figure 55 is a front view of a delivery bottle according to one aspect or embodiment of this application. [Figure 56] Figure 56 is a side view of the delivery bottle shown in Figure 55. [Figure 57] Figure 57 is a partial cross-sectional view of the delivery bottle shown in Figure 55. [Figure 58] Figure 58 is a perspective view of the bypass plunger of the delivery bottle shown in Figure 55. [Figure 59] Figure 59 is a cross-sectional view of the bypass plunger shown in Figure 58. [Figure 60] Figure 60 is a cross-sectional view of the delivery bottle shown in Figure 55, indicating its position before use. [Figure 61] Figure 61 is a cross-sectional view of the delivery bottle shown in Figure 55, indicating the position of use. [Figure 62] Figure 62 is a cross-sectional view of the delivery bottle shown in Figure 55, indicating its position before use. [Figure 63] Figure 63 is a cross-sectional view of the delivery bottle shown in Figure 55, indicating the position of use. [Figure 64] Figure 64 is an enlarged cross-sectional view of the delivery bottle shown in Figure 63. [Figure 65] Figure 65 is a cross-sectional view of the delivery bottle shown in Figure 55, indicating its usage location. [Figure 66] Figure 66 is an enlarged cross-sectional view of the delivery bottle shown in Figure 65. [Figure 67] Figure 67 is a partial front view of the delivery bottle shown in Figure 55. [Modes for carrying out the invention]

[0018] The following description is provided to enable those skilled in the art to create and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutes will be readily apparent to those skilled in the art. All such modifications, variations, equivalents, and substitutes are intended to be within the spirit and scope of the invention.

[0019] Hereafter, for the purpose of explanation, “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “upper surface,” “lower surface,” “lateral direction,” “vertical direction,” and their derivatives shall be used in reference to the orientation of the invention as described herein in the drawings. However, it will be understood that the invention may be based on various alternative modifications unless explicitly specified otherwise. It should also be understood that the specific devices shown in the accompanying drawings and described below are merely exemplary embodiments of the invention. Therefore, specific dimensions and other physical features relating to the embodiments disclosed herein should not be considered limiting.

[0020] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to include the starting and ending values, as well as any and all subranges or subratios contained therein. For example, a designated range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between the minimum value of 1 and the maximum value of 10 (and including the minimum value of 1 and the maximum value of 10), i.e., all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less.

[0021] The terms “first,” “second,” and similar terms are not intended to refer to any particular order or timeline, but rather to different conditions, characteristics, or elements.

[0022] As used herein, “at least one” is synonymous with “one or more.” 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 A's alone, or one or more B's alone, or one or more C's alone, or one or more A's and one or more B's, or one or more A's and one or more C's, or one or more B's and one or more C's, or all of A, B, and C.

[0023] Referring to Figures 1 to 5, in one aspect or embodiment of the present application, the priming device 10 includes a body, a connecting member 12 configured to mate with a corresponding connector of a closed system delivery device, and a handle 16 connected to the body and movable relative to the body between a first position in which the elastomer member 14 and the body define a first volume and a second position in which the elastomer member 14 and the body define a second volume, the second volume being larger than the first volume, the first and second volumes being in fluid communication with the connecting member, and connected to the elastomer member 14 and configured to move the elastomer member 14 between the first and second positions.

[0024] A healthcare professional or patient attaches the connector 12 to a closed system delivery device installed at the end of the IV line, such as the injector of the BD PhaSeal Optima System, commercially available from Becton, Dickinson and Company. The healthcare user pulls the handle 16 to the extended position. The handle 16 clicks into place and remains extended. This deflects the dome-shaped elastomer member 14, which stores energy in its deflected shape and forces a vacuum into the dome-shaped chamber. The vacuum in the dome-shaped chamber draws all the air out of the IV line. The dome-shaped chamber and elastomer member 14 can be sized to hold the amount of air for a particular set of IVs. Once the IV line is fully primed, the priming device 10 is removed and discarded.

[0025] Referring to Figures 6 to 35, according to one aspect or embodiment of the present application, the delivery adapter 100 includes a housing 102, a spike adapter 104 connected to the housing 102 which defines an input channel 106 and an output channel 108, a connecting member 110 configured to mate with a corresponding connector of a closed system delivery device which is in fluid communication with the input channel 106, and a priming valve 112 which includes a valve configuration 114 configured to prevent flow from the spike 104 to the connecting member 110. The system includes a priming valve 112 that enables flow from the connecting member 110 to the spike 104, an output connector 118 that is in fluid communication with a flash reservoir 116 and an output channel 108, the output connector 118 being provided with a check valve 120 to prevent fluid flow from the output connector 118 to the flash reservoir 116, a hydrophilic membrane 122 disposed between the output channel 108 and the output connector 118, and a valve member 124 disposed between the output channel 108 and the flash reservoir 116, and between the output channel 108 and the hydrophilic membrane 122. The valve member 124 is movable between a first position in which the output channel 108 is in fluid communication with the flash reservoir 116 and a second position in which the output channel 108 is in fluid communication with the hydrophilic member 122 and the output connector 118.

[0026] Referring to Figures 24 and 25, the hydrophilic member 122 forms an anti-dry-run device that guides the fluid through the hydrophilic membrane 122. After the membrane 122 is wet, a large pressure is required to pull the fluid through the micropores. This pressure is greater than the height of the gravity head of the infusion set or the height of the gravity head supplied by the pump. When the bag runs out of fluid, air is drawn into the delivery adapter 100 and cannot be pulled through the membrane 122, and a vacuum is applied to the surface of the check valve 120.

[0027] Referring to Figures 26 to 28, in the first step using the delivery adapter 100, the healthcare worker connects the delivery adapter 100 to a bag filled with saline solution and sets the selector switch 124 to the valve position. The fluid path from the bag is directed to the flush reservoir 116, as shown.

[0028] Referring to Figures 29 and 30, in the second step, the healthcare worker connects a syringe and a closed system delivery device, such as the injector of the BD PhaSeal Optima System, commercially available from Becton, Dickinson and Company, to connector 110 and injects e into the bag. The healthcare worker mixes it properly. The fluid path is as shown in Figure 30. Valve configurations 114, such as a check valve, allow flow in the direction shown in Figure 30.

[0029] Referring to Figures 31 and 32, in the third step achieved at the pharmacy or at the time of administration, the healthcare worker connects the IV line injector to the integrated CSTD connector 110. The healthcare worker then primes the drip chamber, which typically generates H1, as shown in Figure 31. The hydrophilic membrane 122 may be wetted to prevent air from the drip chamber from moving into the bag. In this case, an alternative method of priming the drip chamber or an alternative dry-running prevention approach may be required. Due to the head height difference (H1-H2), the IV line is automatically primed with fluid from the saline bag until H1-H2 equals the sum of all pressure losses in the line, leaving a small amount of air at the end of the IV line. At that point, the healthcare worker presses the priming button 112, which forces all fluids and gases through the valve device 114. The restoring force of the priming button 112 draws a vacuum and draws the fluid through the valve device 114. This cycle is repeated until all air is removed from the IV line and the IV line is fully primed with the drug. The healthcare worker then disconnects the CSTD injector and is ready to administer the drug. If, for any reason, air is found to be present in the IV line, these steps can be repeated during administration.

[0030] Referring to Figures 33 and 34, the pump initially draws 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 by one or both of the following methods: (1) the head height of the drug reservoir is higher than that of the flush reservoir 116, keeping the check valve 120 closed; or (2) the check valve 120 may have a minimum cracking pressure that must be overcome before allowing flow. This cracking pressure may be greater than the head height of the flush reservoir 116, but less than that which can be overcome by the pump. When the drug reservoir is empty, the dry-run prevention device engages as described above, creating a vacuum at the check valve. This causes the pump to draw fluid from the flush reservoir 116. The volume of the flush reservoir 116 is sized to approximately match the tubing priming volume so that the drug on the line continues to inject. Infusion is completed when either of the following two scenarios occurs: (1) the pump reaches its VTBI programmed limit; or (2) the flush pack is empty, an upstream occlusion alarm is triggered on the pump, and all medication and flush fluid has been administered.

[0031] Referring to Figures 35 and 36, according to further aspects or embodiments, the infusion delivery device 200 includes a drug reservoir 202 comprising an air portion 204 and a fluid portion 206, a flush reservoir 208 having fluid communication with the drug reservoir 202 via a channel 210, the channel 210 including a clamp 212 configured to isolate the flush reservoir 208 from the drug reservoir 202, and a drip chamber spike adapter 214 having fluid communication with the drug reservoir 202, the drip chamber spike adapter 214 having fluid communication with the drug reservoir 202, the drip chamber spike adapter 214 having fluid communication with the flush reservoir 208 The device includes a flush reservoir 208 and a drip chamber spike adapter 214, which are in fluid communication via a check valve 216 configured to allow flow only to the drip chamber spike adapter 214; a float ball 218 and a receiving cone 220 positioned between the drug reservoir 202 and the drip chamber spike adapter 214; and an input port 222 which is in fluid communication with the drug reservoir 202 and configured to allow fluid to flow into the drug reservoir 202 via the input port 222.

[0032] The drug reservoir 202 may be a flexible bladder having a portion intended for excess air and a portion intended for the drug having volume scale marks. A ring may be provided to hold the drug portion of the bladder in a cylindrical shape having a constant cross-section. A float ball 218 is included within the bladder, and a receiving cone 220 is included within the base of the bladder. A drip chamber spike adapter 214 is included as an interface between the fluid outlet from the bladder and the IV set. The flush reservoir 208 is hydraulically connected to the spike adapter 214 via a check valve 216 (such as a duckbill valve), the check valve 216 remaining closed under hydraulic pressure at the outlet side of the valve 216, and allowing flow through the valve 216 only when a certain amount of vacuum is applied to the outlet or a high-pressure source is applied to the inlet side of the check valve 216. The check valve 216 is positioned such that its inlet is hydraulically coupled to the flush reservoir 208 and its outlet is hydraulically coupled to the outlet of the bladder.

[0033] The bladder is provided either filled with a predetermined volume of base solution or empty. If empty, the pharmacist first fills the bladder with a harmless base solution, such as saline, for the desired dose (e.g., 500 mL). Once the bladder is filled, both parts are filled and all air is removed from the drug reservoir. The pharmacist then closes clamp 212 to ensure that the flush reservoir 208 is separated from the drug reservoir 202. The flush reservoir 208 contains approximately the same volume (e.g., 30 mL) as the tubing used to inject the drug. The pharmacist may optionally attach an IV line to the spike port 214 but does not prime the line. Instead, the pharmacist clamps the IV line. The pharmacist then prepares the concentrated drug, draws the desired dose from the drug source (e.g., vial) into a syringe, and then injects the desired dose into the bladder through the inlet port. The drug is mixed with the contents of the bladder to obtain a diluted drug mixture intended for infusion. The pharmacist then connects the end of the IV line to the inlet port. The height of the drug head in the bladder is sufficient to allow the drug to flow through the IV line, and air from the IV line to be expelled 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. The administering nurse hangs the bag on the chairside IV pole and records the fluid level in the bag on a corresponding mark. This represents the exact amount to be infused, and the nurse programs the pump to deliver this amount over a predetermined time (e.g., 1 hour). The float ball 218 remains stationary above the fluid surface. As the fluid contents are emptied, the float ball 218 lowers in height until it hits the receiving cone 220, at which point forming a fluid seal with the cone 220. The infusion pump continues to draw the fluid, generating sufficient pressure to open the check valve 216. Next, the contents of the flushing reservoir 208 are made available for delivery, resulting in the complete delivery of the drug in the line to the patient.When the bag is empty, the pump either reaches the end of the volume being injected or detects an upstream blockage and alerts the clinical staff that the injection is complete.

[0034] The infusion delivery device 200 in Figures 35 and 36 advantageously provides a method for safely priming an IV line with a drug to enable the provider to avoid delays associated with waiting for primed saline to be injected; a method for measuring the total volume to be injected to enable the administering nurse to correctly program the pump with the correct volume over the desired period, ensuring the rate is correct and avoiding delays associated with bag overfilling and reprogramming; and a method for automatically flushing the IV line of the drug with a base solution, thereby ensuring the total volume is delivered and avoiding delays associated with the secondary tube flushing step.

[0035] Referring to Figures 37 to 54, according to further aspects or embodiments of the present application, the infusion delivery device 300 includes a drug reservoir 302 having a predetermined volume of fluid, a flush reservoir 304 having a predetermined volume of fluid, a drip chamber spike adapter 306 having fluid communication with the drug reservoir 302, the flush reservoir 304 being configured to have fluid communication with the drip chamber spike adapter 306 via a check valve 308, a float ball 310 and a receiving cone 312 positioned between the drug reservoir 302 and the drip chamber spike adapter 306, an input port 314 having fluid communication with the drug reservoir 302 and configured to allow fluid inflow into the drug reservoir 302 via the input port 314, and a priming valve 316 having fluid communication with the input port 314 and the drug reservoir 302.

[0036] In one embodiment, the flush reservoir 304 is formed by a hemispherical shell 318 and a thin film welded to the hemispherical shell. The flush reservoir 304 is in fluid communication with the drip chamber spike adapter 306 via a tube 320 equipped with a flow control clamp 322, although other suitable arrangements may be available. As shown in Figure 45, the drug reservoir 302 may include scale marks or other markers to indicate volume measurement.

[0037] Referring to Figures 55 to 67, a delivery bottle 400 according to one aspect or embodiment of the present application is shown, which may be used in conjunction with the delivery adapter 100 and device 300 described above. The delivery bottle 400 includes an inner sleeve 404 and a cylinder 402 defining an inner volume 404 that receives a bypass plunger 406. The delivery bottle 400 is configured to allow in-line automated flushing of the drug within an architecture intended for precise measurement of the volume to be injected.

[0038] Referring to Figure 59, the bypass plunger 406 includes a body 408 made of 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 including a one-way valve 414 that requires a specific minimum pressure ("cracking pressure") to open, and a hydrophobic membrane 416 that allows air to bypass the plunger 406.

[0039] Referring to Figures 60 and 61, the inner sleeve 404 includes a thin plastic film that can be compressed and stretched to fill the inner space of the cylinder 402, although other suitable arrangements may be utilized.

[0040] Referring to Figures 62-64, the delivery bottle 400, intended for flushing and pre-filled with a diluent (e.g., saline solution), is contained within a sealed space above the bypass plunger 406. A one-way valve 414 prevents the flushing fluid from mixing with the drug solution. The concentrated drug is injected through the integrated CSTD ports 110, 314 and mixed properly. If air enters the drug chamber, it can bypass the plunger 406 through the hydrophobic membrane 416 and remain within the flush chamber.

[0041] Referring to Figure 65, once the drug is delivered, the plunger 406 is pulled down. The seal between the outer seal 410 and the cylindrical wall is intended so that friction is not a significant source of resistance to the plunger's movement. The inner sleeve 404 is capable of expanding / contracting to equalize the pressure due to the air vent contained in the cap. The inner sleeve 404 ensures that the flush solution or potentially harmful air (vapor) is contained within the cylinder 402.

[0042] Referring to Figure 66, when all the drug has been delivered, the bypass plunger 406 seats completely at the bottom of the cylinder 402. This creates a vacuum from the height of the IV line or pump head. This vacuum overcomes the cracking pressure of the one-way valve 414, allowing the flush solution to flow. The cracking pressure of the one-way valve 414 is greater than the frictional resistance of the outer seal 410 against the cylinder wall. The vacuum formed to pull the inner seal 412 against the corresponding seating shape in the outer cylinder 402 ensures that air is not pulled through the hydrophobic film 416.

[0043] Referring to Figure 67, in some aspects or embodiments of this application, the bypass plunger 406 includes a reference line 418 for a medical professional to measure the volume contents of the cylinder. The reference line 418 is included in the outer seal 410.

[0044] While this disclosure has been described to have an exemplary structure, it is subject to further modification within its spirit and scope. Therefore, this application is intended to encompass any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover any deviations from this disclosure that fall within the scope of the appended claims, within the scope of known or customary practices in the relevant art. Wherever possible, one or more features of any aspect or embodiment described above can be combined with one or more features of any other aspect or embodiment.

Claims

1. It is a priming device, The main unit and A connecting member configured to mate with a corresponding connector of a closed system transport device, An elastomer member connected to the main body and movable relative to the main body, wherein the elastomer member and the main body are movable between a first position defining a first volume and a second position defining a second volume, the second volume being larger than the first volume, and the first and second volumes being in fluid communication with the connecting member, A priming device comprising: a handle connected to the elastomer member and configured to move the elastomer member between a first position and a second position.

2. A delivery adapter, Housing and A spike adapter connected to the housing, comprising a spike adapter that defines an input flow path and an output path, A connecting member configured to mate with a corresponding connector of a closed system delivery device, the connecting member having fluid communication with the input channel, A priming valve having fluid communication with the input flow path, comprising a valve configuration configured to allow flow from the connecting member to the spike and to prevent flow from the spike to the connecting member, A flash reservoir that is in fluid communication with the output channel, An output connector that is in fluid communication with the flash reservoir and the output flow path, the output connector including a check valve for preventing fluid flow from the output connector to the flash reservoir, A hydrophilic membrane is disposed between the output channel and the output connector, A delivery device comprising a valve member disposed between the output channel and the flash reservoir, and between the output channel and the hydrophilic membrane, the valve member being movable between a first position in which the output channel is in fluid communication with the flash reservoir and a second position in which the output channel is in fluid communication with the hydrophilic member and the output connector.

3. Infusion delivery device, A drug reservoir comprising an air portion and a fluid portion, A flush reservoir having fluid communication with the drug reservoir via a channel, wherein the channel includes a clamp configured to separate the flush reservoir from the drug reservoir, A drip chamber spike adapter that is in fluid communication with the drug reservoir, wherein the flash reservoir is in fluid communication with the drip chamber spike adapter via a check valve configured to allow flow only from the flash reservoir to the drip chamber spike adapter, A float ball and a receiving cone are disposed between the drug reservoir and the drip chamber spike adapter, An infusion delivery device comprising: an input port configured to communicate fluidly with the drug reservoir and to allow fluid to flow into the drug reservoir via the input port.

4. Infusion delivery device, A drug reservoir having a predetermined volume of fluid, A flush reservoir having a predetermined volume of fluid, A drip chamber spike adapter that is in fluid communication with the drug reservoir, wherein the flash reservoir is in fluid communication with the drip chamber spike adapter via a check valve configured to allow flow only from the flash reservoir to the drip chamber spike adapter, A float ball and a receiving cone are disposed between the drug reservoir and the drip chamber spike adapter, An input port is configured to communicate fluidly with the drug reservoir and to allow fluid to flow into the drug reservoir via the input port, A transport and delivery device comprising the input port and a priming valve that is in fluid communication with the drug reservoir.

Images