Sequential medication administration device

Abstract

A device for sequential administration of medical fluids through a patient connector. The device includes features to interface with a secondary fluid container such as a prefilled saline syringe, to allow aspiration and administration of the primary fluid followed by the secondary fluid without the need for multiple needles or syringes. A system for sequential administration of medical fluids having a flush syringe and device for sequential administration described herein. A kit for sequential administration of medical fluids including a flush syringe and device for sequential administration described herein.

Description

Attorney Docket No. P-30543.W001 BDX0340-00WO1SEQUENTIAL MEDICATION ADMINISTRATION DEVICETechnical Field

[0001] The present invention relates to medical devices, and in particular, devices for sequential medication administration. The present disclosure also generally relates to a dual chamber syringe assembly for administering two gases or fluids, or for administering and flushing catheters and other vascular accessing devices (VADs), or for mixing and administering fluids.Background

[0002] In many clinical settings where a fluid is administered to a patient, it may be desirable to administer two or more fluids in rapid succession to ensure the desired therapeutic effect.

[0003] One example is when an intravenous fluid is administered via a catheter. The fluid is often accompanied with flushing to ensure that the full dose of medication is delivered to the patients. An easy way to accomplish this task would be beneficial and there is an unmet need to provide a device capable of accomplishing both an IV push accompanied with flushing in a quick and efficient manner, especially in high risk and urgent situations. One example of a high risk and urgent situation is adenosine delivery. Adenosine is a medication administered to slow the heart rate of patients in supra ventricular tachycardia (SVT) or assumed to be in SVT based on the presenting cardiac rhythm and heart rate. Adenosine has a roughly six second half-life for it to reach the receptor sites for efficacy. This means the drug is no longer effective / active outside of the first six seconds of delivery. If it takes longer than six seconds to reach the heart, there is no therapeutic effect.

[0004] Current methods for administration are a rapid bolus of the medication, preferably in an intravenous line that is closer to the heart than distally (AC vs Hand), followed by a rapid fluid bolus via syringe, usually 20mL. The fluid bolus is at a distal port or y-site that is distal to the connection of the adenosine site administration.

[0005] One example of a current workflow for administration of adenosine includes: (1) a patient is in a critical heart rhythm and has a symptomatic need to resolve or diagnose the rhythm (due to high rate); (2) a drug is drawn up in syringe, typically a stop cock or distal port is established, and a flush syringe is attached. Once the drug is delivered, an immediate delivery of the flush solution is administered to move the drug to the heart which is imperative forAttorney Docket No. P-30543.W001 BDX0340-00WO2effective treatment. Often a second clinician is present to turn the stopcock and inject the flush for efficacy. The dose can be repeated if there is no therapeutic result. Current method of drug delivery followed by saline involves use of stopcock which requires two people to quickly turn stopcock to deliver the drug to receptor site.

[0006] Intravenous (IV) push of medication in catheters is accompanied with flushing to ensure that the full dose of medication is delivered to the patients. There is an unmet need to provide an easy way to accomplish both an IV push in catheters accompanied with flushing which would be beneficial, especially in high risk and urgent situations. It is desirable to provide new or improved features to deliver a rapid sequence of fluids via a syringe. Delivering fluids or medication, such as adenosine or other medication, via rapid intravenous flush can ensure the desired dose of the therapeutic fluid is expelled from the administration tubing and reaching the receptor sites to achieve desired efficacy.

[0007] There is a need for a medication administration device or assembly which has the means to both flush a VAD and administer a dosage of medical fluid, thereby also reducing the risk of a catheter related bloodstream infection (CRB SI). There is also a need for a sequential medication administration device for administration of intravenous medication followed by I.V. flush, to increase clinician efficiency, and reduce costs associated with maintaining syringe inventory, and medical waste disposal.SUMMARY

[0008] One aspect of the present disclosure pertains to a device for sequential medication administration including a syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen; a plunger having a central flange, a distal end with male threads, a proximal end with a connection interface, and a central passageway extending from the distal end of the plunger to the proximal end of the plunger; and a slitted stopper having a central slit.

[0009] In one or more embodiments, the connection interface is configured to attach to a needleless luer connector. In one or more embodiments, the connection interface is configured as a threaded post.

[0010] In one or more embodiments, the device further includes a tip cap is threaded onto the Luer connector at the distal end of the barrel.Attorney Docket No. P-30543.W001 BDX0340-00WO3

[0011] In one or more embodiments, the slitted stopper is made of a molded, elastomer material. In one or more embodiments, the elastomer material is isoprene rubber.

[0012] Another aspect of the present disclosure pertains to an integrated device for sequential medication administration including a first syringe comprising a syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen, and a chamber to hold a fluid; a first plunger comprising a plunger rod, thumb press, flange and stopper; a second syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen, a second plunger disposed in the second barrel, the second plunger having a central flange, a distal end with male threads, a proximal end with a connection interface, and a central passageway extending from the distal end of the plunger to the proximal end of the plunger; and a slitted stopper having a central slit, wherein the Luer connector on the distal end of the first syringe is configured to attach to the connection interface on the proximal end of the second plunger to allow fluid communication between the first syringe and the slitted stopper.

[0013] In one or more embodiments, the connection interface is configured to attach to a needleless luer connector. In one or more embodiments, the connection interface is configured as a threaded post.

[0014] In one or more embodiments, the integrated device further includes a tip cap configured to be threaded onto the Luer connector at the distal end of the barrel.

[0015] In one or more embodiments, the slitted stopper is made of a molded, elastomer material. In one or more embodiments, the elastomer material is isoprene rubber.

[0016] Another aspect of the present disclosure pertains to a kit including a first syringe comprising a syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen, and a chamber to hold a fluid; a first plunger comprising a plunger rod, thumb press, flange and stopper; a second syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen; a second plunger disposed in the second barrel, the second plunger having a central flange, a distal end with male threads, a proximal end with a connection interface, and a central passageway extending from the distal end of the plunger to the proximal end of the plunger; and a slitted stopper having a central slit, wherein the luer connector on the distal end of the first syringe is configured to attach to the connection interface on the proximal end of the second plunger to allow fluid communication between the first syringe, and the slitted stopper.Attorney Docket No. P-30543.W001 BDX0340-00WO4

[0017] In one or more embodiments, the connection interface is configured to attach to a needleless luer connector.

[0018] In one or more embodiments, the connection interface is configured as a threaded post.

[0019] In one or more embodiments, a tip cap is threaded onto the Luer connector at the distal end of the barrel of the first syringe or the distal end second syringe.

[0020] In one or more embodiments, the slitted stopper is made of a molded, elastomer material. In one or more embodiments, the elastomer material is isoprene rubber.

[0021] Another aspect of the present disclosure pertains to method for sequential medication administration including providing a flush syringe having a barrel, plunger rod, thumb press, flange and stopper a Luer connector; providing the device for sequential medication administration of the present disclosure; attaching the luer connector of the flush syringe to the connection interface of the device for sequential medication administration of the present disclosure; attaching an aspiration element to the luer connector on the distal end of the device for sequential medication administration of the present disclosure; aspirating a fluid into the device for sequential medication administration of the present disclosure by pulling back the flush syringe; connecting the device for sequential medication administration of the present disclosure to a patient connector;exerting pressure on the plunger rod of the flush syringe to expel the aspirated fluid from the device for sequential medication administration of the present disclosure; continuing to exert pressure until the slitted stopper is pushed to the distal end of the device for sequential medication administration of the present disclosure; continuing to apply pressure on the to open the central slit of the slitted stopper to communicate the flush fluid through the slitted stopper and into the patient connector.Brief Description of the Drawings

[0022] FIG. 1 shows a configuration for sequential medication administration using a stopcock with a drug syringe and a saline syringe in current practice.

[0023] FIG. 2 shows a configuration for sequential medication administration using two needles piercing a septum in current practice.

[0024] FIG. 3 shows an example sequential medication administration device according to the present disclosure.

[0025] FIG. 4 shows a sequential medication administration device.Attorney Docket No. P-30543.W001 BDX0340-00WO5

[0026] FIGs. 5A and 5B shows an example workflow of sequential medication administration using the device of FIG. 4.

[0027] FIG. 6 shows two example stoppers that may be included in a sequential medication administration device.

[0028] FIG. 7 shows an example workflow of sequential medication administration using the device of FIG. 3.Detailed Description

[0029] It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and / or features of any embodiment can be combined in any way and / or combination. Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the preferred embodiments that follow, such description being merely illustrative of the present invention.

[0030] The embodiments described herein provide improved rapid delivery of sequential fluids. In addition to the delivery of other medications that require a rapid flush, the utilization of these features offer improvements to current administration practices. One benefit is infection reduction by reducing the number of catheter accesses with a decrease in touch contamination. Another benefit is potentially longer dwell times for catheters. With a decrease in touch contamination from the reduced access attempts, there should be a decrease in catheter (e.g., peripheral interventional catheter (PIV)) failure. Because the device can be prefilled by the pharmacy or purchased prefilled from a pharmaceutical manufacturer, the number of steps and potential for administration errors and / or medication errors can be reduced. The reduction in procedural steps also allows for saving steps in the medication administration process and increased clinician satisfaction.

[0031] The embodiments described herein offer distinct advantages over the two current practices for sequential administration. The features may be useful in different locations where medication is administered such as: acute care settings, emergency medical services, alternate care settings (e.g., urgent care), non-acute care settings (e.g., doctor’s office), in-home care setting, infusion centers, or where medications may be self-administered (e.g., chronically ill patients).Attorney Docket No. P-30543.W001 BDX0340-00WO6

[0032] FIG. 1 shows a configuration for sequential medication administration using a stopcock with a drug syringe and a saline syringe as used in current practice. In this configuration, the clinician uses two syringes, one for the drug and the other for saline. These are connected to a stopcock that needs to be activated immediately after administration from the first syringe to administer from the second syringe. One disadvantage of this configuration is that it requires the stopcock arrangement, including additional preparation time for administration and increased medical waste. Another disadvantage of this current configuration is that it requires manual manipulation of syringes and stopcock which may result in potential error or delay. A further disadvantage of the configuration of FIG. 1 is that the weight of the syringes and stopcock may place extra strain on the catheter causing possible dislodgment or patient discomfort. An example of this practice in action can be seen here: https: / / www.youtube.com / watch?v=WBQrddqWhzo.

[0033] FIG. 2 shows another currently practiced configuration for sequential medication administration using two needles piercing a septum. In this configuration, a clinician uses two syringes, one for the drug and the other for saline. These are simultaneously introduced into the catheter septum and activated sequentially. One disadvantage of this practice is drug leakage as two needles are piercing the septum that may be designed to accommodate only one needle. Another disadvantage is delay in treatment due to needle slippage from septum during administration. A third disadvantage is the configuration relies on needles which carries the risk of accidental needle sticks and associated clinical hazards (e.g., cross-contamination, unintended exposure to drugs or fluids, infection, etc.). An example of this practice in action can be seen here : h t tps : / / w w.you tube . c om / a tc h?v= WB QrddqWhzo .

[0034] Referring now to the drawings, a first aspect of the present disclosure is shown in FIGs.3 is a system 10 for disinfecting and flushing an intravenous patient connector, the system 10 comprising a flush syringe 100 and a sequential medication administration device 200. The flush syringe 100 comprises a syringe barrel 102, which defines an open proximal end 104, and a distal end 106. In one or more embodiments, syringe barrel 102 defines a chamber that may contain a flushing solution. The distal end 106 of the barrel 102 includes a Luer connector 108 defining an outlet lumen 110, for attachment to and fluid communication with various associated VAD connectors, including sequential medication administration device 200. An interior of the barrel 102 is generally defined and bounded by its inner side wall 112, open proximal end 104, and its distal end 106. The outlet lumen 110 is in fluid communication with the interior of the barrel. A plunger 114 is capable of selective translation within the barrelAttorney Docket No. P-30543.W001 BDX0340-00WO7interior. The plunger 114 has a distal end 116 with male threads 118 for coupling to a first plunger stopper 120 by mating female threads 122 formed in the stopper. The mating male 118 and female 122 threads collectively comprise a connection feature to removably or non-removably couple the plunger 114 and plunger stopper 120. Alternatively, in one or more embodiments, the connection feature couples the plunger 114 and the plunger stopper 120 by way of an interference fit. In one or more embodiments, the connection feature couples the plunger 114 and the plunger stopper 120 by way of a snap fit. In one or more embodiments, the connection feature couples the plunger 114 and the plunger stopper 120 by way of a twistlock fit. In one or more embodiments, the connection feature couples the plunger 114 and the plunger stopper 120 by way of sonic welding or a medical grade adhesive. In one or more embodiments, plunger stopper 120 is integrally formed to the distal end 116 of the plunger 114. The distal end 116 of the plunger stopper 120 has an outwardly conical shape. In one or more embodiments, the distal end 116 of the plunger stopper 120 has a frustoconical shape.

[0035] As shown in FIG. 3, system 10 includes a flush syringe 100 that is coupled to the sequential medication administration device 200. Sequential medication administration device 200 comprises syringe barrel 202, the syringe barrel 202 having an open proximal end 204, a distal end 206 that includes a Luer connector 208 defining an outlet lumen 210, Luer connector 208 allow for attachment to and fluid communication with various associated VAD connectors (not shown). A tip cap 212 is threaded onto the Luer connector 208 at the distal end 206 of the barrel to provide closure integrity for the syringe contents through the shelf life and is removed by the user prior to use or administration of medication and flush.

[0036] The barrel 202 is generally defined and bounded by its inner side wall 214, open proximal end 204, and its distal end 206. The outlet lumen 210 is in fluid communication with the interior of the barrel. A secondary plunger 220 is capable of selective translation within the barrel interior. The secondary plunger 220 comprises a central flange 222, a distal end 224 with male threads 225 for coupling to a slitted stopper 230 by mating female threads 232 formed in the stopper. The mating male threads 225 and female 232 threads collectively comprise a connection feature to removably or non-removably couple the secondary plunger 220 and slitted stopper 230. Alternatively, in one or more embodiments, the connection feature couples the plunger 220 and the slitted stopper 230 by way of an interference fit. In one or more embodiments, the connection feature couples the secondary plunger 220 and the slitted stopper 230 by way of a snap fit. In one or more embodiments, the connection feature couples theAttorney Docket No. P-30543.W001 BDX0340-00WO8secondary plunger 220 and the slitted stopper 230 by way of a twist-lock fit. In one or more embodiments, the connection feature couples the secondary plunger 220 and the slitted stopper 230 by way of sonic welding or a medical grade adhesive. In one or more embodiments, slitted stopper 230 is integrally formed to the distal end 224 of the secondary plunger 220. The distal end 232 of the slitted stopper 230 has an outwardly conical shape. In one or more embodiments, the distal end 232 of the slitted stopper 230 has a frustoconical shape. The secondary plunger 220 has a proximal end 226 with an interface configured as a threaded post 228 configured for coupling to the distal end 106 of the barrel 102 of the flush syringe 100 which includes a Luer connector 108 defining an outlet lumen 110 formed in the flush syringe. The secondary plunger 220 comprises a central passageway extending from the distal end 224 through the proximal end 226 to allow for fluid communication between the flush syringe 100 and slitted stopper 230.

[0037] The slitted stopper 230 is oriented in the barrel interior 202 and is translatable between the open proximal end 204 and the distal end 206 of the barrel 202. The slitted stopper 230 has a side wall 238 with a first thickness, with a first axial end 239 facing the secondary plunger 220, a second axial end 240 facing the distal end 206 of the syringe barrel 202, and an internal cavity 242 that is in open communication with its first axial end 239. The second axial end 240 of the side wall 238 forms a dome-shaped septum 248 having a central slit 250. The central slit 250 allows for fluid communication between the internal cavity 242, the outlet lumen 210, the central passageway of the secondary plunger 220 and the outlet lumen 110 of the flush syringe 100. In some embodiments, the slitted stopper 230 comprises a molded, elastomer material, such as isoprene rubber.

[0038] The slitted stopper 230 separates the interior of the syringe barrel 202 into a primary fluid chamber 250, defined between the distal end of the slitted stopper 230 and the distal end 206 of the barrel; and a secondary fluid chamber defined between itself and the contents of the interior of the barrel 102, e.g. a flush solution. Translation of the secondary plunger 220 generates a differential pressure P on the slitted stopper 230, wherein withdrawing the secondary plunger 220 translates the slitted stopper towards the proximal end 204 of the barrel 202. Conversely, advancing the secondary plunger 220 translates the slitted stopper 230 towards the distal end 206 of the syringe barrel 202. When the central slit 250 of the dome-shaped septum 248 is closed, the secondary fluid chamber is isolated from the outlet lumen 210, so that translation of the secondary plunger 220 only aspirates fluid into or dispenses fluid out of the primary chamber 250, via the outlet lumen 210.Attorney Docket No. P-30543.W001 BDX0340-00WO9

[0039] Opening the central slit 250 or flipping of the flap of a flap type stopper is caused solely by application of sufficiently high, differential fluid pressure P, on the slitted stopper 230 or 330 by pressing and translating the plunger 230 towards the distal end 206 of the barrel 202. When differential pressure P on the central slit 250 or the flap of a flap type stopper falls below a buckling differential pressure PB, the central slit 250 or the flap of a flap type stopper relaxes to its first state, closing the central slit 250 or flap, thereby re-closing the slitted stopper or flap type stopper and re-isolating the secondary chamber from the primary chamber 250.

[0040] In one or more embodiments, the primary chamber 250 is pre-filled or filled on site with a desired medicine. In one or more embodiments, the secondary chamber of the flush syringe is pre-filled with a desired amount of a saline flush fluid. In one or more embodiments, the secondary chamber of the flush syringe is filled with a desired medicine. In one or more alternate embodiments, both the primary chamber 250 and secondary chambers are filled with a desired medicine. In one or more alternate embodiments, both the primary chamber 250 and secondary chambers are filled with desired amounts of saline flush fluid. In one or more embodiments, the primary chamber 250 and / or the secondary chamber are pre-filled with fluid during or after the assembly of the syringe 20 using sterile filling methods. A tip cap 212 is threaded onto the Luer connector 208 at the distal end 206 of the barrel to provide closure integrity and to prevent fluid leakage for the syringe contents through the shelf life and is removed by the user prior to use or administration of medication and flush. A tip cap may also be threaded onto the Luer connector 108 at the distal end 106 of the barrel of the flush syringe 100 to provide closure integrity and to prevent fluid leakage for the syringe contents through the shelf life and is removed by the user prior to use or administration of medication and flush.

[0041] FIG. 4 shows an exemplary sequential medication administration device of the present disclosure. The sequential medication administration device 200 may be configured to receive and connect with a prefilled fluid syringe 100 such as a saline flush (e.g., BD PosiFlush™ prefilled saline syringe from Becton, Dickinson and Company in Franklin Lakes, NJ). One specific configuration includes a saline syringe which is integrated with the sequential medication administration device 200 through plunger barrel interface with each other. The device can comes as integrated in packaging making it easier and quicker for the healthcare professional to aspirate and deliver adenosine (or similar) drug to patient in quick possible time.

[0042] In some implementations, the sequential medication administration device may be preattached by the medical device manufacturer. In an alternate embodiment, the sequentialAttorney Docket No. P-30543.W001 BDX0340-00WO10medication administration device is provided to a drug manufacturer or pharmacy in an empty state. The prefilled secondary syringe may then be attached to the sequential medication administration device by the drug manufacturer or pharmacy once filled. In other embodiments, the sequential medication administration device is provided to clinical facility for filling on site, on demand as described.

[0043] FIGs. 5A and 5B shows an example workflow of sequential medication administration using the device of FIG. 4. The steps 4-1, 4-2, 4-3, 4-4, and 4-5 of the workflow shown in FIGs.5A and 5B may be performed manually or by a robotic medication administration system. At step 5-1, the prefilled secondary syringe is inserted into and attached to the sequential medication administration device. In the example shown in FIG. 5A and 5B, the sequential medication administration device is empty and can be filled by, at step 5-2, attaching an aspiration element (e.g., a blunt needle) to one end of the sequential medication administration device. The fluid is aspirated into the sequential medication administration device as the prefilled element is pulled back. In some implementations, the sequential medication administration device includes a dislodgement element on the interior surface to ensure the stopper does not fall out. Once filled, at step 5-3, the loaded sequential medication administration device is connected to a patient connector. At step 5-4, the prefilled element is used to push the stopper which in turn expels the aspirated fluid. Because of the fluid pressure of the aspirated fluid in the sequential medication administration device, the stopper will remain sealed until stopper is pushed to the bottom of the sequential medication administration device. At step 5-5, continued pressure on the prefilled element will urge the fluid in the prefilled element through the duckbill valve stopper and into the patient connector.

[0044] FIG. 6 shows two example stoppers that may be included in a sequential medication administration device. The second slitted stopper 230 includes check valve that prevents the mixing of the aspirated drug with the saline (or other fluid loaded for secondary, sequential delivery). As shown in FIG. 6, the slitted stopper 230 may include a flap type geometry or duckbill valve type geometry. A duckbill type valve is a type of check valve made from rubber or synthetic elastomer, designed to allow fluid to flow in one direction while preventing backflow. It gets its name from its shape, which resembles a duck’s beak. When fluid is pumped through the valve, the “beak” opens to let the fluid pass. When the pressure stops, the beak closes to prevent any backflow. A flap type geometry valve 700, also known as a flap gate, is another type of check valve used to control the flow of fluids. It allows fluid to flow in one directionAttorney Docket No. P-30543.W001 BDX0340-00WO11while preventing backflow. The valve consists of a hinged flap that opens when fluid flows in the desired direction and closes when the flow stops or reverse. As shown in FIG. 6, the flap is formed in a shape of the letter U though other flap geometries such as a V, star, or similar that provide the desired pressure characteristics for sequential medication administration may be implemented.

[0045] In some embodiments, a sterilized sequential medication administration device 200 is separately packaged for coupling with a separate sterile flush syringe 100 (pre-filled or filled on site) prior to patient administration. In other embodiments, the sterilized sequential medication administration device 200 and a pre-filled flush syringe 100 are coupled during manufacture and shipped in sterile packaging, for patient administration by a healthcare provider.

[0046] A sequential medication administration device 200 shown in FIG. 3 may be prefilled / prepared by pharmaceutical company or manufacture. The sequential medication administration device 200 may include a tip cap 212 at maintain sterility of the device 200. A webbing 600 may cover the opposing end of the device 200. If the sequential medication administration device 200 is packaged to prevent contamination, the webbing 600 may be omitted. Once the webbing 600 is removed (or the sequential medication administration device 200 is removed from the packaging), a prefilled syringe can be connected via the interface configured as a threaded post 228 in FIG. 3. The interface may also be configured as a threaded luer connection. The interface includes a fluid path to allow fluid to flow from a connected device 100 and into the sequential medication administration device 200 toward a second slitted stopper 230 (see, e.g., FIG. 6). The operation of the sequential medication administration device in FIG.3 is similar to the operation described in the previous figures. Namely, the secondary fluid syringe can be connected to the interface and used to drive the first stopper 120 to expel the fluid from the sequential medication administration device 200 via outlet lumen 210. Once the first stopper 120 bottoms, the secondary fluid will expel from the secondary fluid syringe through the second stopper 230.

[0047] The sequential medication administration device 200 may come as modified drug syringe in a packaging. The connector at the sequential medication administration device allowing any saline syringe connection to it making it easier and quicker for the healthcare professional to deliver drug (Adenosine or similar) to patient in quick possible time.Attorney Docket No. P-30543.W001 BDX0340-00WO12

[0048] FIG. 7 shows another example sequential medication administration device. The plunger rod 104 in the device in FIG. 7 can be a part of the assembly equipment at the drug manufacturer. The drug manufacturer attaches the plunger rod 104 with the modified drug syringe stopper, aspirate the drug, and then remove the plunger rod to repeat the drug filling process of the next modified drug syringe. The sequential medication administration device 700 shown in FIG. 7 is either assembled or co-packaged with a prefilled flush syringe by the drug manufacturer or the drug manufacturer may supply the filled device 700 to the pharmacy for attaching with the prefilled flush syringe (or other secondary fluid syringe). In some implementations, the plunger 104 may be removed from the interface (e.g., similar to interface 106) sequential medication administration device 700 once filled and ready to be transferred to a clinical care area. In some implementations, the sequential medication administration device 700 may include a cap (e.g., similar to cap 602).

[0049] FIG. 8 shows an example workflow of sequential medication administration using the device of FIG. 6. The steps 8-1, 8-2, 8-3, and 8-4 of the workflow shown in FIG. 8 may be performed manually or by a robotic medication administration system. At 8-1, the prefilled sequential medication administration device is unpacked. At 8-2, a secondary fluid syringe is either obtained (e.g., prefilled or empty and filled with the secondary fluid). At 8-3, the secondary fluid syringe is connected via the interface to the sequential medication administration device. Once secured, the cap may be removed to allow connecting the sequential medication administration device to a patient connector. At 8-4, the secondary fluid syringe is pushed into the sequential medication administration device to cause the stopper to expel the prefilled fluid. Once the stopper hits bottom of the sequential medication administration device, the secondary fluid syringe plunge will urge the secondary fluid syringe stopper toward the sequential medication administration device. In doing so, the secondary fluid will be expelled through the interface to the patient connector.

[0050] The sequential medication administration device features described offer distinct advantages over current methods. One advantage is the single integrated device that can be used quickly for time sensitive sequential medication deliveries. Another advantage is that once the device is connected with the secondary syringe, it does not rely on overly complicated maneuvers to aspirate or administer the primary fluid. Further, the proposed features allow the primary fluid to be provided in a smaller, contaminant free, prefilled form.

Claims

Attorney Docket No. P-30543.W001 BDX0340-00WO13CLAIMSWe claim:

1. A device for sequential medication administration comprising:a syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen,a plunger having a central flange, a distal end with male threads, a proximal end with a connection interface, and a central passageway extending from the distal end of the plunger to the proximal end of the plunger; anda slitted stopper having a central slit.

2. The device of claim 1, wherein the connection interface is configured to attach to a needleless luer connector.

3. The device of claim 1, wherein the connection interface is configured as a threaded post.

4. The device of claim 1, further comprising a tip cap is threaded onto the Luer connector at the distal end of the barrel.

5. The device of claim 1, wherein the slitted stopper is made of a molded, elastomer material.

6. The device of claim 4, wherein the elastomer material is isoprene rubber.

7. An integrated device for sequential medication administration comprising:a first syringe comprising a syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen, and a chamber to hold a fluid;a first plunger comprising a plunger rod, thumb press, flange and stopper; a second syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen,a second plunger disposed in the second barrel, the second plunger having a central flange, a distal end with male threads, a proximal end with a connection interface, and a central passageway extending from the distal end of the plunger to the proximal end of the plunger; and a slitted stopper having a central slit,Attorney Docket No. P-30543.W001 BDX0340-00WO14wherein the Luer connector on the distal end of the first syringe is configured to attach to the connection interface on the proximal end of the second plunger to allow fluid communication between the first syringe and the slitted stopper.

8. The integrated device of claim 7, wherein the connection interface is configured to attach to a needleless luer connector.

9. The integrated device of claim 7, wherein the connection interface is configured as a threaded post.

10. The integrated device of claim 7, further comprising a tip cap is threaded onto the Luer connector at the distal end of the barrel.

11. The integrated device of claim 7, wherein the slitted stopper is made of a molded, elastomer material.

12. The integrated device of claim 11, wherein the elastomer material is isoprene rubber.

13. A kit comprising:a first syringe comprising a syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen, and a chamber to hold a fluid;a first plunger comprising a plunger rod, thumb press, flange and stopper a second syringe barrel having an open proximal end, a distal end having a Luer connector defining an outlet lumen,a second plunger disposed in the second barrel, the second plunger having a central flange, a distal end with male threads, a proximal end with a connection interface, and a central passageway extending from the distal end of the plunger to the proximal end of the plunger; and a slitted stopper having a central slit,wherein the luer connector on the distal end of the first syringe is configured to attach to the connection interface on the proximal end of the second plunger to allow fluid communication between the first syringe, and the slitted stopper.Attorney Docket No. P-30543.W001 BDX0340-00WO1514. The integrated device of claim 13, wherein the connection interface is configured to attach to a needleless luer connector.

15. The integrated device of claim 13, wherein the connection interface is configured as a threaded post.

16. The integrated device of claim 13, further comprising a tip cap is threaded onto the Luer connector at the distal end of the barrel.

17. The integrated device of claim 13, wherein the slitted stopper is made of a molded, elastomer material.

18. The integrated device of claim 17, wherein the elastomer material is isoprene rubber.

19. A method for sequential medication administration comprising:providing a flush syringe having a barrel, plunger rod, thumb press, flange and stopper a Luer connector;providing the device of claim 1 ;attaching the luer connector of the flush syringe to the connection interface of the device of claim 1 ;attaching an aspiration element to the luer connector on the distal end of the device of claim 1;aspirating a fluid into the device of claim 1 by pulling back the flush syringe; connecting the device of claim 1 to a patient connector;exerting pressure on the plunger rod of the flush syringe to expel the aspirated fluid from the device of claim 1 ;continuing to exert pressure until the slitted stopper is pushed to the distal end of the device of claim 1 ;continuing to apply pressure on the to open the central slit of the slitted stopper to communicate the flush fluid through the slitted stopper and into the patient connector.

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