Dual Chamber Syringe Assembly

Abstract

A syringe having two variable volume portions is described herein. The syringe includes a first stopper and a second stopper, the first stopper being coupled to a plunger. The first variable volume portion is disposed between the first stopper and the second stopper, and the second variable volume portion is disposed between the second stopper and a distal end of the syringe barrel. A flow path structure is disposed at the distal end of the barrel, and the flow path structure extends from the distal end of the barrel along an inner sidewall of the barrel.

Description

[Technical Field]

[0001] SUMMARY OF THE INVENTION Embodiments of the present disclosure relate to a dual chamber syringe assembly for administering two gases or fluids or for administering and flushing a catheter or another vascular access device (VAD), as well as a method for flushing a catheter. [Background technology]

[0002] VADs are commonly used therapeutic devices and include IV catheters. There are two general categories of VADs: peripheral vascular catheters and central venous catheters. If not properly maintained, VADs can become blocked. Practice standards have been developed to ensure VADs are used properly and do not become blocked. These standards include cleaning procedures, commonly referred to as flushing procedures or catheter flushing.

[0003] Standard practice for VADs typically recommends that flush procedures be performed after catheter replacement, before fluid infusion, and before and after medication administration, blood withdrawal, transfusion, and parenteral nutrition. The purpose of these flush procedures is to confirm catheter patency, avoid medication incompatibilities, ensure complete medication administration, prevent thrombus formation, and minimize the risk of bloodstream infection. Flush procedures require different types and amounts of flush solution. The most commonly used flush solutions are saline and / or heparin lock solution. The type and amount of flush solution vary depending on the specific type of catheter. A flush solution volume of 5 to 10 ml is most common, but can range from 1 to 20 ml.

[0004] For flushing procedures, an IV line refers to a system that includes a VAD, a tubing set with a clamp, and may be separated by a port or valve. The most common type of port is covered by a pierced or pre-slit septum, known in the art and sometimes referred to as "PRN," from the Latin "prorenata," meaning "as needed." The septum is preferably made of rubber or another elastomeric material and allows insertion of a sharp needle cannula to inject or withdraw fluids from the catheter. Upon withdrawal of the needle cannula, the septum closes itself. Ports with pre-slit septums are used with blunt cannulas or the frustoconical tip of a syringe barrel. The syringe tip or blunt cannula (usually attached to a syringe) is gently pushed through the pre-slit septum to establish fluid communication.

[0005] IV valves, another type of distal IV access device that does not require a sharp-tipped needle, are activated by a frustoconical tip on the syringe barrel to provide fluid communication between the inside of the syringe and the catheter. These valves may include structure for delivering fluid from a storage compartment in the valve to the catheter and are referred to in the art as positive displacement valves.

[0006] Removal of deposits or debris is referred to as "cleaning" or "flushing" and prevents the buildup of blood, blood debris, and IV medications within the catheter or other VAD device. Such buildup can result in partial or complete blockage of the flow path in the catheter system, necessitating expensive and potentially dangerous procedures to clean the affected catheter or replace the entire catheter. Often, such blockage results in an interruption of therapy that may compromise patient care. Buildup of debris within the catheter can also increase the risk of infection by providing a growth medium for microorganisms.

[0007] As understood by those skilled in the art, flushing techniques involve injecting a flushing solution, such as saline, into the VAD to clear deposits and blockages. Injection is typically accomplished by advancing the plunger rod into a pre-filled syringe barrel, thereby expelling the flushing solution into the VAD. When used in conjunction with a catheter, such techniques introduce turbulent airflow into the catheter to dislodge deposits or debris that have become attached to the catheter. Flushing techniques involve the application of a substantially constant pressure or force to the plunger rod in a distal direction. A traditional or smooth flushing technique may also involve the application of a substantially linearly increasing or decreasing pressure or force to the plunger rod in a distal direction.

[0008] After flushing, the practitioner can then administer a volume of medicinal fluid that is in a vial or a separate prefilled syringe that requires withdrawal. However, connecting multiple devices to a VAD introduces connectors into a non-sterile external environment, thereby introducing the potential for catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal. To reduce CRBSI cases and ensure VADs are used and maintained correctly, standards of practice have been developed, including disinfection and cleaning procedures.

[0009] The administration of intravenous medications followed by an IV flush typically uses two separate syringes in medical practice.

[0010] A need exists for a syringe assembly that is meant to both flush the VAD and administer a consistent amount of medical fluid, thereby reducing the risk of CRBSI. There is also a need for a single syringe for IV flushing after administration of intravenous medication to increase physician efficiency and reduce medical waste, which benefits the environment. Summary of the Invention

[0011] A first embodiment of the present disclosure relates to a flush syringe assembly including a substantially cylindrical barrel, a plunger, first and second stoppers, first and second variable volume portions, and a flow path structure. The substantially cylindrical barrel has an open proximal end, a proximal end, and an inner sidewall, a needleless connector extending from a distal end, and a lumen therethrough, the lumen being in fluid communication with a cavity in the barrel, the cavity being defined by the open proximal end, the distal end, and the inner sidewall. The plunger is disposed within the barrel with a plunger rod. The distal end includes a coupling feature extending distally from the distal end. The first stopper is disposed proximal to the second stopper, the first stopper including a proximal end, a distal end, and an outer surface, the proximal end including an aperture configured to receive the coupling feature of the plunger rod. The second stopper is disposed proximal to the distal end of the barrel, the second stopper having a proximal end, a distal end, and an outer surface. The first variable volume portion is disposed between the first stopper and the second stopper. The second variable volume portion is between the second stopper and the distal end of the barrel. The flow path structure is disposed at the distal end of the barrel, the flow path structure extending from the distal end of the barrel along the inner sidewall of the barrel.

[0012] In one or more embodiments, the flow path structure is a protrusion extending from the inner sidewall of the barrel, the protrusion having a semicircular cross-sectional shape. In one or more embodiments, the flow path structure is a protrusion extending from the inner sidewall of the barrel, the protrusion having a convex cross-sectional shape.

[0013] In one or more embodiments, the flow path structure is a protrusion extending from the inner sidewall of the barrel, the protrusion having a concave cross-sectional shape. In one or more embodiments, the flow path structure is a unitary structure molded into the inner sidewall of the barrel. In one or more embodiments, the flow path structure is a non-unitary structure assembled into the inner sidewall of the barrel.

[0014] In one or more embodiments, the first stopper further comprises a plurality of radial ribs disposed on an outer surface of the first stopper.

[0015] In one or more embodiments, the second stop further comprises a plurality of radial ribs disposed on an outer surface of the second stop.

[0016] In one or more embodiments, the proximal end of the second stopper has an inwardly facing conical shape that is positioned to receive the distal end of the first stopper.

[0017] In one or more embodiments, the distal end of the second stopper has an outwardly conical shape that matches and is received by the distal end of the barrel.

[0018] In one or more embodiments, the interlocking feature comprises a plurality of threads for engaging a plurality of internal threads integral to the aperture of the first stopper.

[0019] In one or more embodiments, the needleless connector is integral with the distal end of the barrel.

[0020] In one or more embodiments, the flow path structure extends at least the length of the second stopper, thereby creating a flow path between the second stopper and the inner sidewall of the barrel when the second stopper abuts the distal end of the barrel.

[0021] In one or more embodiments, the flow path structure creates a flow path from the second variable volume portion to the lumen of the barrel when the second stopper is fully adjacent the distal end of the barrel.

[0022] In one or more embodiments, advancement of the second stopper toward the distal end of the barrel causes deformation of the second stopper by the flow path structure obstructing the second stopper.

[0023] In one or more embodiments, advancement of the second stopper relative to the distal end of the barrel creates a fluid path between the second stopper and the syringe barrel.

[0024] In one or more embodiments, the distal end of the barrel has a frusto-conical shape.

[0025] In one or more embodiments, the flow path structure continues into a frusto-conical shape at the distal end of the barrel. In one or more embodiments, the flow path structure extends into the lumen of the barrel.

[0026] In one or more embodiments, the flow channel structure has a beveled proximal end, thereby allowing for less restrictive advancement of the second stopper relative to the flow channel.

[0027] In one or more embodiments, the flow path structure has a first thickness profile TP1 along the inner sidewall of the barrel and a second thickness profile TP2 along the distal end of the barrel, where the first thickness profile TP1 is greater than the second thickness profile TP2.

[0028] In one or more embodiments, the syringe is in an initial state, an intermediate state, and a final state. In one or more embodiments, the initial state is defined by the plunger fully retracted in the cavity, the first stopper and the second stopper separated within the cavity by the first variable volume portion, and the second stopper and the distal end of the barrel separated within the cavity by the second variable volume portion. In one or more embodiments, the intermediate state is defined by the plunger in a partially advanced position within the cavity, and the second stopper fully advanced relative to the distal end of the barrel, such that advancement of the second stopper causes removal of the contents of the second variable volume portion through the lumen, thereby removing the second variable volume portion. In one or more embodiments, the final state is defined by the plunger fully advanced within the cavity, and the distal end of the first stopper abutting the proximal end of the second stopper, thereby removing the first variable volume portion. [Brief explanation of the drawings]

[0029] [Figure 1]FIG. 1 shows a cross-sectional view of the syringe assembly in an initial state. [Figure 2] FIG. 2 shows a cross-sectional view of the syringe assembly of FIG. 1 in an intermediate state. [Figure 3A] 3A shows a perspective view of a first stopper of the syringe assembly of FIG. 1. FIG. [Figure 3B] 3B shows a perspective view of the first stopper of the syringe assembly of FIG. 1. FIG. [Figure 3C] FIG. 3C shows a cross-sectional view of the first stopper of FIG. 3A. [Figure 4A] 4A shows a perspective view of a second stopper of the syringe assembly of FIG. 1. FIG. [Figure 4B] 4B shows a perspective view of the second stopper of the syringe assembly of FIG. 1. FIG. [Figure 4C] FIG. 4C shows a cross-sectional view of the first stopper of FIG. 4A. [Figure 5A] FIG. 5A shows a cross-sectional view of the syringe assembly of FIG. 1 in a final state. [Figure 5B] FIG. 5B shows a cross-sectional view of the syringe assembly of FIG. 1 in a final state. [Figure 5C] FIG. 5C shows a cross-sectional view of the syringe assembly of FIG. 1 in a final state. [Figure 5D] FIG. 5D shows a cross-sectional view of the syringe assembly of FIG. 1 in a final state. [Figure 6A] FIG. 6A shows a cross-sectional view of the syringe assembly of FIG. 1 in a final state. [Figure 6B] FIG. 6B shows a cross-sectional view of the syringe assembly of FIG. 1 in a final state. DETAILED DESCRIPTION OF THE INVENTION

[0030] (Detailed Description of the Invention) Before describing several specific embodiments of the present invention, it is to be understood that this disclosure is not to be considered as limiting the details of construction or method steps set forth in the following description, as this disclosure may enable other embodiments and may be practiced or carried out in various ways.

[0031] In the embodiments of this disclosure, by convention, the distal end of the device is the end closest to the patient, and the proximal end of the device is the end furthest from the patient and closest to the practitioner.

[0032] The following definitions are provided for terms used in this disclosure.

[0033] As used herein, "a," "an," and "the" include the singular and the plural.

[0034] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection that occurs due to the presence of a catheter or IV line.

[0035] As used herein, the term "Luer connector" refers to an interlocking collar, which is a standard method of attaching syringes, catheters, hub needles, IV tubing, and the like. Luer connectors consist of a slightly tapered, interlocking male and female tube that hold together well with just a simple pressure / slip fit. Luer connectors can optionally include an additional threaded outer rim to make the Luer connector more secure. The male end of the Luer connector typically mates with a flush syringe and can mate with and connect to a female end located on a vascular access device (VAD). Luer connectors also have a distal end channel that releasably attaches the Luer connector to the hub of a VAD and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.

[0036] As used herein, ISO 80369-7:2016 provides details for a standard Luer connector with a 6% taper between the distal and proximal ends. Male standard Luer connectors increase in size from the open distal end to the proximal end. Female standard Luer connectors decrease in size from the open proximal end to the distal end. In accordance with ISO 80369-7:2016, male standard Luer connectors have a cross-sectional outer diameter, measured 0.75 mm from the distal end of the tip, between 3.970 mm and 4.072 mm. The length of the male standard Luer taper is between 7.500 mm and 10.500 mm. The cross-sectional outer diameter, measured 7.500 mm from the distal end of the tip, is between 4.376 mm and 4.476 mm. As used herein, "male standard luer connector" and "female standard luer connector" refer to connectors having dimensions set forth in ISO 80369-7, which is incorporated herein by reference in its entirety.

[0037] As will be readily understood by those skilled in the art, descriptive terms such as "tip," "hub," "thread," "protrusion / insert," "tab," "slope," "wall," "top," "side," "bottom," and others are used throughout this specification to facilitate understanding, but are not intended to limit any components that may be used, in combination or alone, to implement various implementations of embodiments of the present disclosure.

[0038] The matters embodied in this description are provided to facilitate a complete understanding of the exemplary embodiments of the disclosure. Therefore, those skilled in the art will understand that various changes and modifications to the embodiments described herein can be made without departing from the scope and spirit of the present disclosure. Furthermore, descriptions of well-known functions and configurations have been omitted for clarity and conciseness.

[0039] In exemplary implementations of embodiments of the present disclosure, the syringe barrel includes a distal end having a needleless connector, hi one or more embodiments, the needleless connector includes at least one thread and any other features, in any or all combinations, that allow it to interlock with one or more corresponding threads of a corresponding connector.

[0040] According to a further exemplary implementation of an embodiment of the present disclosure, the arrangement of structural elements making up the needleless connector includes a collar protruding from the distal end of the barrel, the collar including at least one thread that interlocks with one or more corresponding threads on a corresponding connector.

[0041] According to still further exemplary implementations of embodiments of the present disclosure, the collar or needleless connector may generally bend or elastically deform to conform with a corresponding connector with a good interference fit.

[0042] According to still further exemplary implementations of embodiments of the present disclosure, the needleless connector may include female threads having a thread pattern that will mate with a standard ISO 594-2 type of male fitting, and / or male threads having a thread pattern that will mate with a standard ISO 594-2 type of female fitting, an example of which is a Q-style fitting.

[0043] In one or more embodiments, the female connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0044] In one or more embodiments, the male connector may be the end of an intravenous tubing or a stopcock.

[0045] Referring now to the drawings, wherein reference numerals indicate like or corresponding parts throughout the several views, embodiments of the present disclosure are shown below.

[0046] A first embodiment of the present disclosure relates to a syringe 100 having a barrel 110 and a plunger 102. As shown in Figures 1 and 2, the barrel 110 is cylindrically shaped with an open proximal end, a distal end 114, and an inner sidewall 112. A needleless connector 116 extends from the distal end 114, and the needleless connector 116 is integral with the distal end 114. The needleless connector 116 has a lumen 118 extending therethrough, which is in fluid communication with a cavity 120 in the barrel 110, which is defined by the open proximal end, the distal end 114, and the inner sidewall 112 of the barrel 110. The distal end 114 has a frustoconical shape.

[0047] The plunger 102 comprises a plunger rod 103 having a distal end 104 coupled to a first stopper 140. The distal end 104 of the plunger rod 103 comprises a coupling feature 106 extending distally from the distal end 104 of the plunger rod 103. The coupling feature 106 is positioned to be removably or non-removably coupled to the first stopper 140. In one or more embodiments, the coupling feature 106 couples with the first stopper 140 via a threaded coupling. In one or more embodiments, the coupling feature 106 couples with the first stopper 140 via an interference fit. In one or more embodiments, the coupling feature 106 couples with the first stopper 140 via a snap fit. In one or more embodiments, the coupling feature 106 couples with the first stopper 140 via a twist-lock fit. In one or more embodiments, the coupling feature 106 couples to the first stopper 140 via ultrasonic welding or a medical-grade adhesive. In one or more embodiments, the first stopper 140 is integrally formed with the distal end 104 of the plunger rod 103.

[0048] 1 and 2, at least two stoppers are disposed within cavity 120, such that the at least two stoppers include a first stopper 140 and a second stopper 150. Second stopper 150 is disposed proximal to distal end 114 of barrel 110, and first stopper 140 is disposed proximal to second stopper 150. Between second stopper 150 and distal end 114 is first variable volume portion 142, which is within cavity 120. Between first stopper 140 and second stopper 150 is second variable volume portion 152, which is within cavity 120.

[0049] As shown in FIGS. 3A-3C , first stopper 140 includes a proximal end 144, a distal end 146, and an outer surface 147 disposed between proximal end 144 and distal end 146. In one or more embodiments, proximal end 144 includes an aperture 160 for receiving coupling feature 106 of plunger rod 103. In one or more embodiments, aperture 160 includes a plurality of internal threads for engaging coupling feature 106 of plunger rod 103. In one or more embodiments, proximal end 144 further includes a plurality of radial protrusions. Distal end 146 of first stopper 140 has an outwardly facing conical shape. In one or more embodiments, distal end 146 has a frustoconical shape. In one or more embodiments, outer surface 147 of first stopper 140 includes a plurality of radial ribs 148.

[0050] As shown in FIGS. 4A-4C , second stopper 150 includes a proximal end 154, a distal end 156, and an outer surface 157 disposed between proximal end 154 and distal end 156. Proximal end 154 of second stopper 150 has an inwardly facing conical shape disposed to receive the distal end (not shown) of first stopper 140. The outwardly facing conical shape of distal end 156 of second stopper 150 is disposed to fit over and be received by distal end 114 of barrel 110. In one or more embodiments, outer surface 157 of second stopper 150 includes a plurality of radial ribs 158. In one or more embodiments, distal end 156 includes a plurality of axial ribs 159, which face toward a central portion of second stopper 150. In one or more embodiments, proximal end 154 has a frusto-conical shape. In one or more embodiments, the distal end 156 has a frusto-conical shape.

[0051] 1 , first stopper 140 is coupled to distal end 104 of plunger rod 103 by coupling feature 106, and the plunger advances within cavity 120 of barrel 110. In a preferred embodiment, coupling feature 106 is at least one external thread disposed on distal end 104 of plunger rod 103, which couples to internal threads disposed within aperture 160 of first stopper 140.

[0052] A second embodiment of the present disclosure relates to a flow channel structure 170 disposed at the distal end 114 of the barrel 110. As shown in Figures 5A-5D, the flow channel structure extends from the distal end 114 along the inner sidewall 112 of the barrel 110. As shown in Figures 5C and 5D, advancement of the second stopper 150 relative to the distal end 114 of the barrel 110 causes deformation of the second stopper 150 by the flow channel structure 170 obstructing the second stopper 150.

[0053] Deformation of the second stopper 150 allows fluid to flow between the flow path structure 170 and the second stopper 150. In particular, as best shown in FIG. 5C , the flow path structure 170 extends at least the length of the second stopper 150, thereby creating a flow path between the second stopper 150 and the inner sidewall 112 of the barrel 110 when the second stopper 150 is adjacent the distal end 114 of the barrel 110. As shown in FIGS. 5A and 5B , the flow path structure 170 continues the frustoconical shape of the distal end 114 of the barrel 110. In one or more embodiments, the flow path structure 170 extends into the lumen 118 of the barrel 110. As shown in FIG. 5C , when the second stopper 150 is completely adjacent the distal end 114 of the barrel 110, the flow path structure 170 creates a flow path from the second variable volume portion 152 to the lumen 118 of the barrel 110. In one or more embodiments, the flow path structure 170 has a sloped proximal end 172, which allows for less restrictive advancement of the second stopper 150 relative to the flow path structure 170. In one or more embodiments, as best shown in FIG. 5B , the flow path structure 170 has a first thickness profile TP1 along the inner sidewall 112 of the barrel 110 and a second thickness profile TP2 along the frustoconical shape of the distal end 114 of the barrel 110. In one or more embodiments, the first thickness profile TP1 is greater than the second thickness profile TP2.

[0054] In one or more embodiments, the flow path structure 170 is in the form of a protrusion extending from the inner sidewall 112 of the barrel 110, the protrusion having a semicircular or convex cross-sectional shape. In one or more embodiments, the flow path structure 170 is in the form of a protrusion extending from the inner sidewall 112 of the barrel 110, the protrusion having a concave cross-sectional shape.

[0055] In one or more embodiments, the flow path structure 170 is a unitary structure molded into the inner sidewall 112 of the barrel 110. In one or more embodiments, the flow path structure 170 is a non-unitary structure assembled into the inner sidewall 112 of the barrel 110.

[0056] FIG. 1 shows syringe 100 in an initial state, with first stopper 140 and second stopper 150 separated within cavity 120 by first variable volume portion 142 or second variable volume portion 152. In the initial state, the plunger is in a position that allows it to be further retracted. FIG. 2 shows syringe 100 in an intermediate state, with plunger 102 partially advanced into cavity 120. In the intermediate state, second stopper 150 is fully advanced relative to distal end 114 of barrel 110, which advancement causes the contents of second variable volume portion 152 to be expelled through lumen 118, thereby essentially removing second variable volume portion 152. 6A and 6B show syringe 100 in its final state, with plunger 102 fully advanced into cavity 120 such that distal end 146 of second stopper 150 abuts distal end 144 of barrel 110, thereby essentially removing second variable volume portion 152. For purposes of illustration, as shown in FIG. 6A, a space is shown between first stopper 140 and second stopper 150 in the final state; however, as shown in FIG. 6B, first stopper 140 is fully adjacent second stopper 150 in the final state.

[0057] Because liquids are incompressible, when advancement of plunger 102 advances first stopper 140 distally within cavity 120, the increased fluid pressure on first variable volume portion 142 causes second stopper 150 to move distally, forcing the fluid or contents of second variable volume portion 152 out of lumen 118 of needleless connector 116. Advancement of first stopper 140 distally to its final position further increases fluid pressure, forcing the fluid or contents of first variable volume portion 142 out through lumen 118 of needleless connector 116 and through the flow path created by flow path structure 170. The steady advancement of plunger 102 into barrel 110 can provide laminar flow in a relatively controlled manner.

[0058] In one or more embodiments, the first variable volume portion 142 is filled with a desired amount of saline flush fluid. In one or more embodiments, the first variable volume portion 142 is filled with a desired medication. In one or more embodiments, the second variable volume portion 152 is filled with a desired amount of saline flush fluid. In one or more embodiments, the second variable volume portion 152 is filled with a desired medication. In one or more embodiments, the first variable volume portion 142 and the second variable volume portion 152 are filled with a desired amount of saline flush fluid. In one or more embodiments, the first variable volume portion 142 and the second variable volume portion 152 are filled with a desired amount of medication. Additionally, the barrel 110 of the syringe 100 may include measurement indicia to indicate the amount of flush solution contained therein. The first variable volume portion 142 and the second variable volume portion 152 may be pre-filled with flush solution during or after use of the syringe 100 assembly using a sterile filling method.

[0059] Exemplary flush solutions include saline flush solutions and / or heparin lock flush solutions. These solutions are known in the art and are readily available. One specific example of a saline flush solution is 0.9% sodium chloride, USP, for injection. One specific example of a heparin lock flush solution is 0.9% sodium chloride with 100 USP units of heparin sodium per ml or 0.9% sodium chloride with 10 USP units of heparin sodium per ml.

[0060] The syringes 100 described herein may include visual or other indicators to indicate the position of the first stopper 140 and the second stopper 150 .

[0061] Throughout this specification, a reference to "one embodiment," "an embodiment," "one or more embodiments," or "an embodiment" means that a particular feature, structure, material, or characteristic described with respect to that embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "in an embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0062] Although the disclosure herein has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A syringe comprising a cylindrical barrel, a plunger, a first stopper, a second stopper, a first variable capacity portion, a second variable capacity portion, and a flow path structure portion, the cylindrical barrel having a proximal end, a distal end, and an inner sidewall, a needleless connector extending from the distal end of the barrel, and a lumen passing through the needleless connector, the lumen being in fluid communication with a cavity of the barrel, the cavity being defined by the proximal end, the distal end, and the inner sidewall; the plunger is disposed within the barrel and has a plunger rod, a distal end, the distal end of the plunger comprising a coupling feature extending distally from the distal end of the plunger, the coupling feature being selected from the group consisting of a threaded coupling, an interference fit, a snap fit, a twist-lock fit, an ultrasonic weld, a medical grade adhesive, and combinations thereof; the first stopper is disposed proximal to the second stopper, the first stopper having a proximal end, a distal end, and an outer surface, the proximal end of the first stopper having an aperture disposed to receive the coupling feature of the distal end of the plunger rod; the second stopper is disposed proximal to the distal end of the barrel, the second stopper having a proximal end, a distal end, and an outer surface; the first variable capacitance portion is disposed between a first stopper and a second stopper, the second variable volume portion is between the second stopper and the distal end of the barrel; the flow path structure is disposed at a distal end of the barrel, the flow path structure extending from the distal end of the barrel along an inner sidewall of the barrel; The flow path structure portion protrudes from the inner sidewall of the barrel to cause deformation of the second stopper, and the flow path structure portion extends at least the length of the second stopper, thereby creating a flow path from the second variable volume portion to the lumen of the needleless connector when the second stopper is adjacent to the distal end of the barrel.

2. The syringe according to claim 1 , wherein the flow path structure has a semicircular cross-sectional shape.

3. The syringe according to claim 1 , wherein the flow path structure has a convex cross-sectional shape.

4. The syringe according to claim 1 , wherein the flow path structure has a concave cross-sectional shape.

5. 10. The syringe of claim 1, wherein the flow path structure is a unitary structure molded into the inner sidewall of the barrel.

6. 10. The syringe of claim 1, wherein the flow path structure is a non-unitary structure assembled into the inner sidewall of the barrel.

7. The syringe of claim 1 , wherein the first stopper further comprises a plurality of radial ribs disposed on an outer surface of the first stopper.

8. The syringe of claim 1 , wherein the second stopper further comprises a plurality of radial ribs disposed on an outer surface of the second stopper.

9. 10. The syringe of claim 1, wherein the proximal end of the second stopper has an inwardly facing conical shape positioned to receive the distal end of the first stopper.

10. 10. The syringe of claim 1, wherein the distal end of the second stopper coincides with the distal end of the barrel and has an outwardly facing conical shape arranged to be received by the distal end of the barrel.

11. The syringe of claim 1 , wherein the interlocking feature comprises a plurality of threads for engaging a plurality of internal threads integral with an aperture of the first stopper.

12. The syringe of claim 1 , wherein the needleless connector is integral with the distal end of the barrel.

13. 2. The syringe of claim 1, wherein advancement of the second stopper relative to the distal end of the barrel causes deformation of the second stopper by a flow path structure that obstructs the second stopper.

14. 14. The syringe of claim 13, wherein advancement of the second stopper relative to the distal end of the barrel creates a flow path between the second stopper and the barrel.

15. The syringe of claim 1 , wherein the distal end of the barrel has a frustoconical shape.

16. 16. The syringe of claim 15, wherein the flow path structure continues into a frusto-conical shape at the distal end of the barrel.

17. The syringe of claim 16 , wherein the flow path structure extends into a lumen of the needleless connector.

18. 10. The syringe of claim 1, wherein the flow path structure has a beveled proximal end, thereby allowing less restrictive advancement of the second stopper relative to the flow path structure.

19. 2. The syringe of claim 1, wherein the flow path structure has a first thickness profile TP1 along an inner sidewall of the barrel and a second thickness profile TP2 along a distal end of the barrel.

20. 20. The syringe of claim 19, wherein the first thickness profile TP1 is greater than the second thickness profile TP2.

21. The syringe of claim 1 , wherein the syringe is in an initial state, an intermediate state, and a final state.

22. 22. The syringe of claim 21, wherein the initial state is defined by the plunger in a fully retracted position in the cavity, and the first stopper and the second stopper are separated within the cavity by a first variable volume portion, and the second stopper and the distal end of the barrel are separated within the cavity by a second variable volume portion.

23. 22. The syringe of claim 21, wherein the intermediate state is defined by the plunger in a partially advanced position within the cavity and the second stopper fully advanced relative to the distal end of the barrel, and advancement of the second stopper causes removal of the contents of the second variable volume portion through the lumen, thereby necessarily removing the second variable volume portion.

24. 22. The syringe of claim 21, wherein the final state is defined by the plunger in a fully advanced position within the cavity and the distal end of the first stopper abutting the proximal end of the second stopper, thereby removing the first variable volume portion.

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