Pre-charging adapter for infusion lines

Abstract

A pre-charging device includes a body, a connection member configured to mate with a corresponding connector of a closed system transfer device, an elastic member connected to the body and movable relative to the body between a first position in which the elastic member and the body define a first volume and a second position in which the elastic member and the body define a second volume, wherein the second volume is greater than the first volume, the first and second volumes being in fluid communication with the connection member, and a pull handle connected to the elastic member and configured to move the elastic member between the first and second positions.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 581,759, filed on September 11, 2023, entitled “Priming Adapter for Infusion Line,” the disclosure of which is incorporated herein by reference in its entirety. Technical Background Technical Field

[0002] This disclosure generally relates to the concept of pre-filled delivery pipelines. Background Technology

[0003] The reconfiguration, transportation, and administration of hazardous medications (e.g., cancer treatments) by healthcare providers can expose them to these agents and pose a hazard to the healthcare environment. Unintentional chemotherapy exposure can affect the nervous system, damage the reproductive system, and increase the risk of future blood cancers. Some medications require dissolution or dilution before administration, which involves transferring the solvent from a container to a sealed vial containing the medication in powder or liquid form using a needle. If any pressure difference exists between the inside of the vial and the surrounding atmosphere, the medication may be inadvertently released into the atmosphere as a gas or aerosol during needle withdrawal from the vial and while the needle is inside the vial. To reduce the risk of healthcare providers being exposed to toxic medications, the transfer of these medications is accomplished using a closed system transfer device or system.

[0004] Three challenges leading to significant inefficiencies have been observed in the administration of chemotherapy via intravenous (IV) infusion. Given that these steps are performed in an outpatient oncology setting, delays can have a significant impact on patient throughput through the institution and disrupt patients’ personal schedules.

[0005] Pre-filling with saline infusion: Because chemotherapy drugs are hazardous, IV lines are typically pre-filled with a basic solution (e.g., saline) before being connected to the bag containing the drugs or before the drugs are injected into the bag containing the basic solution via syringe. Given that IV lines can typically hold up to 30 ml (mL) of fluid, the saline in the line is infused into the patient at a prescribed rate (e.g., 120 ml / hour (mL / hr)) and it may take approximately 15 minutes for the drug to first enter the patient's body.

[0006] Bag overfill: Measuring the precise volume of the infusion bag after the pharmacist has prepared the medication is a challenge. Typically, pharmacists receive pre-filled saline bags with some inherent variability in volume (approximately +10%), and then add an extra volume (approximately 10 mL to 100 mL) when administering the medication. Thus, the nurse administering the medication dilutes a precise amount of medication into a less precise amount of saline. In the industry, this is commonly referred to as "bag overfill" and is observed when a volumetric pump has delivered the intended volume for infusion, but the clinician observes fluid remaining in the bag containing a portion of the medication to be infused. Therefore, the clinician must reprogram the pump to deliver the bag's contents. The reprogrammed amount is an estimate and, for outpatient oncology infusion procedures, may add approximately 30 minutes to the infusion time.

[0007] Flushing: After the bag is emptied, the tubing typically dries out (filled with air) up to the pump's onboard air sensor. Once the pump detects air, it alerts the clinician that the infusion is complete. However, the medication remains below the pump in the tubing connecting the bag to the patient. In some cases, this medication volume is clinically significant, requiring the clinical team to take the extra step of flushing with saline at the correct rate. These additional steps can add approximately 10 minutes to the infusion time for outpatient oncology infusion procedures.

[0008] Overall, these inefficiencies represent a potential waste of up to 55 minutes during chemotherapy infusion.

[0009] U.S. Patent No. 10,413,6622, granted to Yeh et al., relates to a pre-filling device and method for venting air from a conduit coupled to a liquid reservoir. Summary of the Invention

[0010] In one aspect or embodiment, a pre-charge device includes: a body; a connecting member configured to mate with a corresponding connector of a closed-system transfer device; an elastic member connected to the body and movable relative to the body between a first position and a second position, wherein in the first position the elastic member and the body define a first volume, and in the second position the elastic member and the body define a second volume, wherein the second volume is larger than the first volume, and the first and second volumes are in fluid communication with the connecting member; and a handle connected to the elastic member and configured to move the elastic member between the first and second positions.

[0011] In another aspect or embodiment, a delivery adapter includes: a housing; a spike adapter connected to the housing, wherein the spike adapter defines an input flow path and an output flow path; a connecting member configured to mate with a corresponding connector of a closed-system transfer device, wherein the connecting member is in fluid communication with the input flow path; a pre-charge ball in fluid communication with the input flow path, wherein the pre-charge ball includes 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 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 that prevents fluid from flowing 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 component is movable between a first position and a second position. In the first position, the output flow path is in fluid communication with the flushing reservoir, and in the second position, the output flow path is in fluid communication with the hydrophilic component and the output connector.

[0012] In another aspect or embodiment, an infusion delivery device includes: a drug reservoir comprising an air portion and a fluid portion; a flushing reservoir in fluid communication with the drug reservoir via a channel, wherein the channel includes a clamp configured to isolate the flushing reservoir from the drug reservoir; a drip chamber needle adapter in fluid communication with the drug reservoir, wherein the flushing reservoir is in fluid communication with the drip chamber needle adapter via a check valve configured to allow flow only from the flushing reservoir to the drip chamber needle adapter; a float and a receiving cone positioned between the drug reservoir and the drip chamber needle adapter; and an input port in fluid communication with the drug reservoir and configured to allow fluid to flow through the input port into the drug reservoir.

[0013] In another aspect or embodiment, an infusion delivery device includes: a drug reservoir having a predetermined fluid volume; a flushing reservoir having a predetermined fluid volume; a drip chamber needle adapter in fluid communication with the drug reservoir, wherein the flushing reservoir is in fluid communication with the drip chamber needle adapter via a check valve configured to allow flow only from the flushing reservoir to the drip chamber needle adapter; a float and a receiving cone positioned between the drug reservoir and the drip chamber needle adapter; an input port in fluid communication with the drug reservoir and configured to allow fluid to flow through the input port into the drug reservoir; and a pre-filled ball in fluid communication with the input port and the drug reservoir. Attached Figure Description

[0014] The above and other features and advantages of this disclosure, as well as the ways in which they are realized, will become more apparent from the following description of various aspects of this disclosure, taken in conjunction with the accompanying drawings, and the disclosure itself will be better understood: Figure 1 This is a perspective view of a pre-charging device according to one aspect or embodiment of this application; Figure 2 yes Figure 1 A three-dimensional view of the device; Figure 3 yes Figure 1 A cross-sectional view of the device, showing the device in its pre-use position; Figure 4 yes Figure 1 A cross-sectional view of the device, showing the transition position of the device; Figure 5 yes Figure 1 A cross-sectional view of the device, showing its location of use; Figure 6 This is a perspective view of a delivery adapter according to one aspect or embodiment of this application; Figure 7 yes Figure 6 A 3D view of the adapter; Figure 8 yes Figure 6 Front view of the adapter; Figure 9 yes Figure 6 Rear view of the adapter; Figure 10 yes Figure 6 A cross-sectional view of the adapter; Figure 11 yes Figure 6 A partial sectional view of the adapter; Figure 12 yes Figure 6 Side view of the adapter housing; Figure 13 yes Figure 6 A 3D view of the adapter's housing; Figure 14 yes Figure 6 Rear view of the adapter housing; Figure 15 yes Figure 6 A 3D view of the adapter's housing; Figure 16 yes Figure 6 A 3D view of the adapter's housing; Figure 17 yes Figure 6 A bottom view of the adapter housing; Figure 18 yes Figure 6 A cross-sectional view of the adapter, showing the unfilled area of ​​the reservoir; Figure 19 yes Figure 6 A cross-sectional view of the adapter, showing the filled position of the reservoir; Figure 20 is Figure 6 The front view of the adapter shows the valve in its first position; Figure 21 yes Figure 6 A partial cross-sectional view of the adapter, showing the fluid path and the first position of the valve; Figure 22 is Figure 6 The front view of the adapter shows the valve in its second position; Figure 23 yes Figure 6 A partial cross-sectional view of the adapter, showing the fluid path and the second position of the valve; Figure 24 yes Figure 6 A partial cross-sectional view of the adapter, showing the anti-drying device; Figure 25 yes Figure 6 A partial perspective view of the adapter, showing the anti-drying device; Figure 26 yes Figure 6 The front view of the adapter shows the first step of using the adapter according to one aspect or embodiment of this application; Figure 27 yes Figure 6 A perspective view of the adapter, which illustrates the first step of using the adapter according to one aspect or embodiment of this application; Figure 28 yes Figure 6 A cross-sectional view of the adapter, which shows the first step of using the adapter according to one aspect or embodiment of this application; Figure 29 yes Figure 6 The front view of the adapter shows the second step of using the adapter according to one aspect or embodiment of this application; Figure 30 yes Figure 6 A partial cross-sectional view of the adapter, which shows the second step of using the adapter according to one aspect or embodiment of this application; Figure 31 yes Figure 6 The front view of the adapter shows the third step of using the adapter according to one aspect or embodiment of this application; Figure 32 yes Figure 6 A cross-sectional view of the adapter, which shows the third step of using the adapter according to one aspect or embodiment of this application; Figure 33 This illustrates one aspect or embodiment of the present application. Figure 6 A schematic diagram of the adapter's components and fluid path; Figure 34 yes Figure 6 A partial cross-sectional view of the adapter, showing the fluid path of the flushing valve; Figure 35 This is a partial cross-sectional view of an anti-drying device according to another aspect or embodiment of this application; Figure 36 This is a front view of an infusion delivery apparatus according to one aspect or embodiment of this application; Figure 37 This is a perspective view of an infusion delivery apparatus according to another aspect or embodiment of this application; Figure 38 yes Figure 37 Front view of the device; Figure 39 yes Figure 37 A perspective view of the flushing chamber housing of the device; Figure 40 yes Figure 37 A partial front view of the device; Figure 41 yes Figure 37 A partial side view of the device; Figure 42 yes Figure 37 A side view of the device; Figure 43 yes Figure 37 Front view of the device; Figure 44 yes Figure 37 A top view of the device; Figure 45 yes Figure 37 A side view of the device, showing scale markings or indicators on the reservoir; Figure 46 yes Figure 37 A perspective view of the device, showing the first step of using the device; Figure 47 yes Figure 37 A perspective view of the device, showing the second step of using the device; Figure 48 yes Figure 37 A perspective view of the device, showing the third step in using the device; Figure 49 yes Figure 37 A perspective view of the device, showing the fourth step in using the device; Figure 50This is a perspective view of an infusion delivery apparatus according to another aspect or embodiment of this application; Figure 51 This is a front view of an infusion delivery apparatus according to another aspect or embodiment of this application; Figure 52 This is a perspective view of an infusion delivery apparatus according to another aspect or embodiment of this application; Figure 53 This is a perspective view of an infusion delivery apparatus according to another aspect or embodiment of this application; Figure 54 This is a perspective view of an infusion delivery apparatus according to another aspect or embodiment of this application; Figure 55 This is a front view of a delivery bottle according to one aspect or embodiment of this application; Figure 56 yes Figure 55 Side view of the delivery bottle; Figure 57 yes Figure 55 A partial cross-sectional view of the delivery bottle; Figure 58 yes Figure 55 A three-dimensional view of the bypass plunger of the delivery bottle; Figure 59 yes Figure 58 A cross-sectional view of the bypass plunger; Figure 60 yes Figure 55 A cross-sectional view of the delivery bottle, showing its position before use; Figure 61 yes Figure 55 A cross-sectional view of the delivery bottle, showing its usage location; Figure 62 yes Figure 55 A cross-sectional view of the delivery bottle, showing its position before use; Figure 63 yes Figure 55 A cross-sectional view of the delivery bottle, showing its usage location; Figure 64 is Figure 63 An enlarged cross-sectional view of the delivery bottle shown; Figure 65 yes Figure 55 A cross-sectional view of the delivery bottle, showing its usage location; Figure 66 yes Figure 65 An enlarged cross-sectional view of the delivery bottle shown; and Figure 67 yes Figure 55 A partial front view of the delivery bottle shown; In all the views, corresponding reference numerals denote corresponding parts. The examples set forth herein illustrate exemplary aspects of this disclosure, and these examples should not be construed as limiting the scope of this disclosure in any way. Detailed Implementation

[0015] The following description is provided to enable those skilled in the art to make and use the aspects contemplated for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will be apparent to those skilled in the art. Any and all such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0016] In the following text, for descriptive purposes, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives shall be used in connection with the present invention as oriented as shown in the accompanying drawings. However, it should be understood that the invention may employ various alternative variations unless explicitly stated otherwise. It should also be understood that the specific apparatus and processes shown in the accompanying drawings and described in the following specification are merely exemplary aspects of the invention. Therefore, specific dimensions and other physical characteristics relating to the aspects disclosed herein should not be considered limiting.

[0017] Unless otherwise stated, all ranges or ratios disclosed herein should be understood to encompass the starting and ending values ​​and any and all subranges or subratios contained therein. For example, the stated range or ratio “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 (inclusive); that is, all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less.

[0018] The terms “first” and “second” are not intended to refer to any particular order or sequence, but rather to different conditions, properties or elements.

[0019] 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 two or more of A, B, or C. For example, “at least one of A, B, and C” includes only one or more A; or only one or more B; or only one or more C; or one or more A and one or more B; or one or more A and one or more C; or one or more B or one or more C; or one or more A, one or more B, and one or more C.

[0020] refer to Figures 1 to 5In one aspect or embodiment of this application, the pre-charge device 10 includes: a body; a connecting member 12 configured to mate with a corresponding connector of a closed-system transfer device; an elastic member 14 connected to the body and movable relative to the body between a first position and a second position, wherein in the first position the elastic member 14 and the body define a first volume, and in the second position the elastic member 14 and the body define a second volume, wherein the second volume is larger than the first volume, and wherein the first and second volumes are in fluid communication with the connecting member; and a handle 16 connected to the elastic member 14 and configured to move the elastic member 14 between the first and second positions.

[0021] Healthcare professionals or patients attach the connecting member 12 to a closed-system transfer device (e.g., a syringe from the BD PhaSeal Optima system, available from Becton, Dickinson and Company), which is installed at the end of the IV line. The medical user pulls the handle 16 to the extended position. The handle 16 engages and remains extended. This causes the dome-shaped resilient member 14 to deflect, storing energy in its deformed shape and creating a vacuum within the dome chamber. The vacuum within the dome chamber evacuates all air from the IV line. The dimensions of the dome chamber and the resilient member 14 can be configured to maintain the air volume of a particular IV set. When the IV line is fully pre-charged, the pre-charge device 10 is removed and discarded.

[0022] refer to Figures 6 to 35According to one aspect or embodiment of this application, the delivery adapter 100 includes: a housing 102; a needle adapter 104 connected to the housing 102, wherein the needle adapter 104 defines an input flow path 106 and an output flow path 108; a connecting member 110 configured to mate with a corresponding connector of a closed-system transfer device, wherein the connecting member 110 is in fluid communication with the input flow path 106; and a pre-charged ball 112 in fluid communication with the input flow path 106, wherein the pre-charged ball 112 includes a valve configuration 114 configured to allow flow from the connecting member 110 to the needle 104. The system includes: a flushing reservoir 116 in fluid communication with the output flow path 108; an output connector 118 in fluid communication with both the flushing reservoir 116 and the output flow path 108, wherein the output connector 118 includes a check valve 120 that prevents fluid from flowing from the output connector 118 to the flushing 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 flushing reservoir 116, and between the output flow path 108 and the hydrophilic membrane 122. The valve member 124 is movable between a first position in which the output flow path 108 is in fluid communication with the flushing reservoir 116, and a second position in which the output flow path 108 is in fluid communication with both the hydrophilic member 122 and the output connector 118.

[0023] refer to Figure 24 and Figure 25 The hydrophilic component 122 forms a flow-proof device that guides fluid through the hydrophilic membrane 122. After the membrane 122 is wetted, a significant pressure is required to draw fluid through the micropores. This pressure is greater than the gravity head of the infusion kit or the pressure provided by the pump. When the fluid in the bag is depleted, air is drawn into the delivery adapter 100 and cannot be drawn through the membrane 122, thus creating a vacuum on the surface of the check valve 120.

[0024] refer to Figures 26 to 28 In the first step of using the delivery adapter 100, healthcare personnel connect the delivery adapter 100 to a bag filled with saline solution and set the selector switch 124 to the valve position. As shown, the fluid path from the bag points to the flush reservoir 116.

[0025] refer to Figure 29 and Figure 30In the second step, healthcare personnel connect the syringe and closed-system transfer device (e.g., a syringe from the BD PhaSeal Optima system, available from Becton Dickinson) to connector 110 and inject the concentrated medication into the bag. The healthcare personnel then mix the medication as usual. The fluid path is as follows: Figure 30 As shown. Valve configuration 114 (e.g., a check valve) allows for... Figure 30 The flow is in the direction shown.

[0026] refer to Figure 31 and Figure 32 In the third step, completed at the pharmacy or point of administration, healthcare personnel connect the IV line syringe to the Integrated Closed System Transfer Device (CSTD) connector 110. Healthcare personnel pre-fill the infusion chamber, typically producing... Figure 31 H1 is shown. The hydrophilic membrane 122 can be wetted, which will prevent air from entering the bag from the infusion chamber. If this is the case, an alternative method of pre-filling the infusion chamber or an alternative anti-drying method may be required. Due to the head difference (H1-H2), the IV line will be automatically pre-filled 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 this point, the healthcare professional presses the pre-fill button 112, which forces all fluid and gas through valve configuration 114. The reset force of the pre-fill button 112 creates a vacuum and draws fluid through valve configuration 114. This cycle is repeated until all air is expelled from the IV line and the IV line is fully pre-filled with medication. The healthcare professional disconnects the CSTD syringe, and medication can now be administered. If air is found in the IV line for any reason, these steps can be repeated during administration.

[0027] refer to Figure 33 and Figure 34Because of the presence of check valve 120, the pump will first draw fluid from the drug reservoir. Check valve 120 uses one or both of the following methods to prevent flow from flush reservoir 116: (1) the head height of the drug reservoir is higher than that of flush reservoir 116, keeping check valve 120 closed; or (2) check valve 120 may be set with a minimum opening pressure that must be overcome before flow is permitted. This opening pressure may be greater than the head height of flush reservoir 116, but less than the pressure that the pump can overcome. When the drug reservoir is empty, the anti-drying device will engage as described above, thereby creating a vacuum on the check valve. This will cause the pump to draw fluid from flush reservoir 116. The volume of flush reservoir 116 will be set to approximately match the pre-filled volume of the pipeline, so that the drug in the pipeline will be continuously infused. Infusion will be completed when either of the following two conditions occurs: (1) the pump reaches the programmed limit of the infusion volume (VTBI); or (2) the flush pack is empty, triggering an upstream blockage alarm on the pump, which means that all medication and flush fluid have been administered.

[0028] refer to Figure 35 and Figure 36 According to another aspect or embodiment, the infusion delivery device 200 includes: a drug reservoir 202 comprising an air section 204 and a fluid section 206; a flushing reservoir 208 in fluid communication with the drug reservoir 202 via a channel 210, wherein the channel 210 includes a clamp 212 configured to isolate the flushing reservoir 208 from the drug reservoir 202; and a drip chamber needle adapter 214 in fluid communication with the drug reservoir 202, wherein the flushing reservoir 208 is connected to a check valve 21. 6. Fluid communication with the infusion chamber needle adapter 214, the check valve 216 is configured to allow only flow from the flush reservoir 208 to the infusion chamber needle adapter 214; a float 218 and a receiving cone 220 are positioned between the drug reservoir 202 and the infusion chamber needle adapter 214; and an inlet port 222 is fluidly communication with the drug reservoir 202 and is configured to allow fluid to flow through the inlet port 222 into the drug reservoir 202.

[0029] The drug reservoir 202 may be a flexible bladder having a portion designed for excess air and a portion with volumetric markings designed for the drug. A ring may be provided to maintain the drug portion of the bladder in a cylindrical shape with a uniform cross-section. A float 218 is included in the bladder, and a receiving cone 220 is included in the base of the bladder. An infusion chamber needle adapter 214 is included as the fluid outlet of the bladder and an interface to the IV kit. The flush reservoir 208 is hydraulically connected to the needle adapter 214 via a check valve 216 (e.g., a duckbill valve), which remains closed under hydraulic pressure on the outlet side of the valve 216 and allows fluid to flow through the valve 216 only when a certain 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 of the valve 216 is hydraulically coupled to the flush reservoir 208, and the outlet of the valve 216 is hydraulically coupled to the outlet of the bladder.

[0030] The capsule is configured to be either filled with a predetermined amount of base solution or empty. If the capsule is empty, the pharmacist will first fill it with a safe base solution (e.g., a predetermined dose of saline, e.g., 500 mL). As the capsule is filled, both portions are filled, and all air is allowed to be incorporated into the drug reservoir. The pharmacist will then close clamp 212, ensuring that flush reservoir 208 is isolated from drug reservoir 202. Flushing reservoir 208 contains approximately the same volume as the tubing used for drug infusion (e.g., 30 mL). The pharmacist may optionally attach an IV line to needle port 214, but without pre-filling the line. Instead, the pharmacist clamps the IV line. The pharmacist then prepares the concentrated drug and draws the desired dose of drug from a drug source (e.g., vial) into a syringe, then injects the desired dose into the capsule through the infusion port. The drug is allowed to mix with the contents of the capsule, resulting in a diluted drug mixture for infusion. The pharmacist then connects the end of the IV line to the infusion port. The head of the medication in the sac is sufficient to allow the medication to flow through the IV line, and air from the IV line is expelled into the sac and rises to the top of the medication 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 pre-filled with medication. The administering nurse hangs the bag on the chair-side IV stand and observes the graduations corresponding to the bag's fluid level. This represents the precise volume to be infused, and the nurse programs the pump to deliver that volume over a specified time (e.g., 1 hour). Float 218 is positioned at the top of the fluid surface. As the fluid contents are emptied, float 218 decreases in height until it abuts against receiving cone 220, at which point float 218 forms a liquid seal with cone 220. The infusion pump continuously draws fluid and generates sufficient pressure to open check valve 216. The contents of flush reservoir 208 are then allowed to be delivered, ensuring the medication in the line is completely delivered to the patient. When the bag is emptied, the pump either reaches the end of the volume to be infused or senses an upstream blockage and alerts clinical staff that the infusion is complete.

[0031] Figure 35 and Figure 36 The infusion delivery device 200 advantageously provides: a method for safely prefilling an IV line with medication, which allows the provider to avoid delays associated with waiting for prefilled saline infusion; a method for measuring the final infusion volume, which allows the administering nurse to correctly program the pump with the accurate volume over the expected duration, thereby ensuring the correct rate and avoiding delays associated with bag overfilling and reprogramming; and a method for automatically flushing the IV line with medication using a basal solution, thereby ensuring that the full dose has been delivered and avoiding any delays associated with a second line flushing step.

[0032] refer to Figures 37 to 54According to another aspect or embodiment of this application, the infusion delivery device 300 includes: a drug reservoir 302 having a predetermined fluid volume; a flushing reservoir 304 having a predetermined fluid volume; an infusion chamber needle adapter 306 in fluid communication with the drug reservoir 302, wherein the flushing reservoir 304 is in fluid communication with the infusion chamber needle adapter 306 via a check valve 308 configured to allow only flow from the flushing reservoir 304 to the infusion chamber needle adapter 306; a float 310 and a receiving cone 312 positioned between the drug reservoir 302 and the infusion chamber needle adapter 306; an input port 314 in fluid communication with the drug reservoir 302 and configured to allow fluid to flow through the input port 314 into the drug reservoir 302; and a pre-filled ball 316 in fluid communication with the input port 314 and the drug reservoir 302.

[0033] In one aspect or embodiment, the flushing reservoir 304 is formed of a hemispherical housing 318 and a membrane welded to the hemispherical housing. The flushing reservoir 304 is in fluid communication with the infusion chamber needle adapter 306 via a conduit 320 having a flow-controlling clamp 322; however, other suitable arrangements may be used. Figure 45 As shown, the drug reservoir 302 may include graduation marks or other markings to indicate volume measurements.

[0034] refer to Figures 55 to 67 The illustration shows a delivery bottle 400 according to one aspect or embodiment of this application, which can be used in conjunction with the aforementioned delivery adapter 100 and device 300. The delivery bottle 400 includes a cylinder 402 defining an internal volume 404 that houses an inner sleeve 404 and a bypass plunger 406. The delivery bottle 400 is configured to enable automated flushing of in-line medication within an architecture designed for accurate measurement of the infusion volume.

[0035] refer to Figure 59 The bypass plunger 406 includes: a body 408 made of rigid plastic; an outer seal 410 designed 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 (“opening pressure”) to open; and a hydrophobic membrane 416 that allows air to bypass the plunger 406.

[0036] refer to Figure 60 and Figure 61 The inner sleeve 404 includes a thin plastic membrane that can be compressed and stretched to fill the internal space of the cylinder 402, but other suitable arrangements may also be used.

[0037] refer to Figures 62 to 6 4. Delivery bottle 400 is configured to be pre-filled with a diluent (e.g., saline). The volume intended for flushing is comprised in an enclosed space above bypass plunger 406. One-way valve 414 prevents the flushing fluid from mixing with the drug fluid. Concentrated drugs are typically injected and mixed via integrated CSTD ports 110, 314. If air enters the drug chamber, it is allowed to bypass plunger 406 through hydrophobic membrane 416 and remain in the flushing chamber above.

[0038] refer to Figure 65 When the drug is delivered, the plunger 406 is pulled downwards. The seal between the outer seal 410 and the cylindrical wall is designed so that friction is not a significant source of resistance to the plunger's movement. The inner sleeve 404 is allowed to expand / contract to balance pressure through vents included in the cap. The inner sleeve 404 ensures that flushing solution or potentially hazardous air (vapor) is contained within the cylinder 402.

[0039] refer to Figure 66 Once all the medication has been delivered, the bypass plunger 406 will be fully seated at the bottom of the cylinder 402. This will allow a vacuum to be created through the IV line head or pump. This vacuum will overcome the opening pressure of the check valve 414, thus allowing the flushing solution to flow. The opening pressure of the check valve 414 is greater than the frictional resistance of the outer seal 410 against the cylinder wall. The created vacuum pulls the inner seal 412 against its corresponding seat structure in the outer cylinder 402, ensuring that air is not drawn in through the hydrophobic membrane 416.

[0040] refer to Figure 67 In some aspects or embodiments of this application, the bypass plunger 406 includes a reference line 418 for medical personnel to measure the volume of the contents of the cylinder. The reference line 418 is included in the outer seal 410.

[0041] While this disclosure has been described as having an exemplary design, it can be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or adaptations of this disclosure using its general principles. Furthermore, this application is intended to cover such deviations from this disclosure within practices known or customary in the art to which this disclosure pertains, and such deviations fall within the limitations of the appended claims. To the extent possible, one or more features of any aspect or embodiment described above may be combined with one or more features of any other aspect or embodiment.

Claims

1. A pre-charge device, comprising: main body; A connecting member configured to mate with a corresponding connector of a closed-system transfer device; An elastic member is connected to the body and is movable relative to the body between a first position and a second position, wherein in the first position the elastic member and the body define a first volume, and in the second position the elastic member and the body define a second volume, wherein the second volume is larger than the first volume, and the first and second volumes are in fluid communication with the connecting member; as well as A handle is attached to the elastic member and configured to move the elastic member between a first position and a second position.

2. A delivery adapter, comprising: case; A needle adapter, which is connected to the housing, defines an input flow path and an output flow path; A connecting member configured to mate with a corresponding connector of a closed-system transfer device, the connecting member being in fluid communication with the input flow path; A pre-charged ball in fluid communication with the input flow path, the pre-charged ball including a valve configuration configured to allow flow from the connecting member to the needle and to block flow from the needle to the connecting member; A flushing 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 that prevents fluid from flowing from the output connector to the flush reservoir; A hydrophilic membrane, positioned between the output flow path and the output connector; and A valve component is positioned between the output flow path and the flushing reservoir and between the output flow path and the hydrophilic membrane. The valve component is movable between a first position and a second position. In the first position, the output flow path is in fluid communication with the flushing reservoir. In the second position, the output flow path is in fluid communication with the hydrophilic component and the output connector.

3. A delivery and infusion device, comprising: A drug reservoir, comprising an air section and a fluid section; A flushing reservoir in fluid communication with the drug reservoir via a channel, the channel including a clamp configured to isolate the flushing reservoir from the drug reservoir; A drip chamber needle adapter in fluid communication with the drug reservoir, wherein the flush reservoir is in fluid communication with the drip chamber needle adapter via a check valve configured to allow flow only from the flush reservoir to the drip chamber needle adapter; A float and a receiving cone, the float and the receiving cone being positioned between the drug reservoir and the infusion chamber needle adapter; as well as An input port is in fluid communication with the drug reservoir and is configured to allow fluid to flow through the input port into the drug reservoir.

4. A delivery and infusion device, comprising: A drug reservoir with a predetermined fluid volume; A flushing reservoir with a predetermined fluid volume; A drip chamber needle adapter in fluid communication with the drug reservoir, wherein the flush reservoir is in fluid communication with the drip chamber needle adapter via a check valve configured to allow flow only from the flush reservoir to the drip chamber needle adapter; A float and a receiving cone, the float and the receiving cone being positioned between the drug reservoir and the infusion chamber needle adapter; An input port, which is in fluid communication with the drug reservoir and is configured to allow fluid to flow through the input port into the drug reservoir; as well as A pre-charged ball in fluid communication with the input port and the drug reservoir.

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