Dual chamber syringe assembly with floating stopper

Abstract

A dual chamber syringe facilitates selective drug mixing, dosing and administration, and pre-or post-administration rinsing with a single syringe instrument. The syringe barrel contains an outlet and variable volume primary and secondary fluid chambers separated by a floating stopper. The floating plug defines a dome-shaped split diaphragm having a central slit at an apex thereof. The split diaphragm is a bistable valve that closes the central slit by compression in its warp dimension when the diaphragm is in a first relaxed state and opens the central slit when the diaphragm is flexed or flipped under tension in the warp dimension in a second state. Buckling of the diaphragm wall is caused only by the fluid pressure differential applied by a single plunger, without the diaphragm being in physical contact with any other structure within the syringe.

Description

Technical Field

[0001] The present disclosure generally relates to a dual-chamber syringe assembly for administering two gases or fluids, or for administering and flushing catheters and other vascular access devices (VADs), or for mixing and administering fluids, and a method of flushing a catheter. Background Art

[0002] VADs are commonly used therapeutic devices and include I.V. catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. Without proper maintenance, VADs can become blocked. To ensure the proper use and non-blockage of VADs, practice standards have been developed. These standards include cleaning procedures, which are commonly referred to as flushing procedures or flushing catheters.

[0003] VAD practice standards generally recommend performing flushing procedures after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, infusion, and the administration of parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug incompatibilities, ensure the administration of a complete drug dose, prevent thrombus formation, and minimize the risk of bloodstream infection. Flushing procedures require several types and amounts of flushing solutions. Commonly used flushing solutions are saline and / or heparin lock solutions. The type and amount of flushing solution vary depending on the specific catheter type. The volume of the flushing solution is most commonly between 5 and 10 ml, but can also range from 1 ml to 20 ml.

[0004] For flushing procedures, an I.V. line refers to a system that includes a VAD, a tubing set with a clamp, and may terminate in a port or valve. The most common type of port is covered by a penetrable septum or a septum preformed with a slit and is known in the art and is sometimes referred to as "PRN" (from the Latin pro re nata, meaning "as needed"). The septum is preferably made of rubber or another elastomeric material that allows the insertion of a sharp needle cannula for infusing fluid or withdrawing fluid from the catheter. After the needle cannula is withdrawn, the septum self-seals. Ports with preformed slits are used with the frustoconical end or blunt cannula of a syringe barrel. The syringe end or blunt cannula (generally attached to a syringe) is gently pushed through the preformed slit in the septum to establish fluid communication.

[0005] I.V. valves, as another type of terminal I.V. access device that does not require a needle with a sharp end, are activated by the frustoconical end of a syringe barrel to allow fluid communication between the interior of the syringe and the catheter. These valves can accommodate structures for delivering fluid from a reservoir chamber in the valve to the catheter and are known in the art as positive displacement valves.

[0006] Removing debris or residues is referred to as "flushing" or "irrigation" and prevents blood deposits, blood residues, and I.V. medications from accumulating within the catheter or other VAD device. Such accumulation can cause partial or complete blockage of the fluid path in the catheter system and may also require expensive and potentially dangerous methods to clean the affected catheter or replace the catheter entirely. In many cases, such blockages result in interruption of therapy, which can impact patient care. Accumulation of residues within the catheter also increases the risk of infection by providing a growth medium for microorganisms.

[0007] As will be understood by those skilled in the art, flushing techniques involve injecting a flushing solution (such as a saline solution) into the VAD to clear debris and blockages. The injection is typically accomplished by advancing a plunger rod into a pre-filled syringe barrel to expel the flushing solution into the VAD. When such techniques are used with a catheter, turbulence is introduced within the catheter, moving any debris or residues attached to the catheter. Flushing techniques require applying a substantially constant pressure or force on the plunger rod in the distal direction. Conventional or smooth flushing techniques may also include applying a substantially linearly increasing or decreasing pressure or force on the plunger rod in the distal direction.

[0008] After flushing, the practitioner can then administer a dose of a medical fluid, which is contained in a vial that needs to be withdrawn from or in a separate pre-filled syringe. However, connecting multiple devices to the VAD introduces connectors into a non-sterile external environment, thereby introducing the possibility of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal. To reduce CRBSI cases and ensure proper use and maintenance of the VAD, practice standards have been developed, including disinfection and cleaning procedures.

[0009] In clinical practice, I.V. flushing is performed after intravenous medication administration, typically using two separate syringes.

[0010] There is a need for a syringe assembly having measures for both flushing the VAD and administering a dose of a medical fluid, thereby reducing the risk of CRBSI. There is also a need for a single syringe for performing I.V. flushing after intravenous medication administration to increase clinician efficiency and reduce the costs associated with maintaining syringe inventory and medical waste disposal. SUMMARY OF THE INVENTION

[0011] A dual-chamber syringe facilitates selective drug mixing, metering, and administration through a catheter or other vascular access device (VAD), as well as pre- or post-catheter administration flushing with a single syringe instrument. The syringe barrel includes an outlet, and a variable-volume primary fluid chamber and a secondary fluid chamber separated by a floating plug. A plunger is selectively translatable within the interior of the barrel. The floating plug defines a dome-shaped split diaphragm having a central slit at its apex. The split diaphragm is a bistable valve that closes the central slit by compression in its meridional dimension when the diaphragm is in a first relaxed state, and opens the central slit when the diaphragm buckles (i.e., flips) under tension in the meridional dimension to a second state. The buckling or flipping of the diaphragm wall is caused solely by a fluid pressure differential applied by the plunger, and the diaphragm makes no physical contact with any other structure within the syringe. The isolated secondary chamber configuration advantageously facilitates the use of pre-packaged drugs or flushing solutions in this chamber. In medical procedures where both flushing and drug administration are required through a catheter or other VAD, the use of a syringe of the type disclosed herein reduces the need for multiple infusions and withdrawals with multiple single-function syringes. The use of the disclosed syringe advantageously reduces the risk of patient infection, reduces the costs associated with syringe inventory and subsequent waste disposal, and reduces the clinician time required to complete the associated medical procedure.

[0012] One aspect of the present disclosure relates to a syringe that includes a generally cylindrical barrel defining a first inner wall. The barrel has an open proximal end and a distal end, wherein the distal end of the barrel includes a connector that defines an outlet lumen therethrough. The outlet lumen is in fluid communication with the interior of the barrel; the interior is defined by the open proximal end, the distal end, and the first inner wall of the barrel. The syringe includes a plunger having a proximal end and a distal end, wherein its distal end is disposed within the interior of the barrel. The plunger is selectively translatable along its axis within the interior of the barrel. A plunger stopper is coupled to the distal end of the plunger, wherein the plunger stopper has a distal end surface facing the distal end of the barrel. A monolithic, single-structure floating stopper is oriented within the interior of the barrel and is translatable between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall that defines a stopper lumen that is open to communication with its first axial end. The second axial end of the drum-shaped sidewall is joined to the circumferential base of a dome-shaped diaphragm that defines an apex. The diaphragm wall forming the diaphragm has a first side in communication with the stopper lumen and a second side. The diaphragm wall also defines a central slit that penetrates both its first and second sides at the apex. The diaphragm wall of the dome-shaped diaphragm forms a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state, and opens the central slit when the diaphragm buckles under tension in the radial dimension and is in a second state. The open central slit allows pressurized fluid to flow out of the second side of the diaphragm from the stopper lumen, wherein the buckling of the diaphragm wall is caused only by a pressure differential resulting from the fluid pressure in the stopper lumen on the first side being higher than the fluid pressure on its second side, and the diaphragm wall has no physical contact with any other structure within the syringe. A primary fluid chamber is within the interior of the barrel and is defined between the diaphragm of the floating stopper and the outlet lumen. The primary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume of the primary fluid chamber is selectively variable by translation of the plunger. The syringe has a secondary fluid chamber within the interior of the barrel and is defined between the distal end surface of the plunger stopper and the diaphragm of the floating stopper. The secondary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume and fluid pressure within the secondary fluid chamber can be selectively changed by translation of the plunger. When the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger draws fluid into or dispenses fluid out of the primary chamber only via the outlet lumen. When the fluid pressure differential between the secondary fluid chamber and the stopper lumen is increased enough to cause the wall of the dome-shaped diaphragm to buckle to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen such that further translation of the plunger toward the distal end of the barrel dispenses fluid out of the secondary chamber via the outlet lumen.

[0013] In some embodiments of the syringe disclosed herein, the secondary chamber is pre-filled with a flushing solution. Desirably, in these embodiments, the clinician can administer the medicament to the patient's VAD with the primary chamber by a single continuous forward movement of the plunger and immediately flush the VAD with the second chamber without removing the syringe from the VAD and without manipulating additional valves or plungers.

[0014] Another aspect of the present disclosure relates to a syringe that includes a generally cylindrical barrel defining a first inner wall, where the barrel has an open proximal end and a distal end. The distal end of the barrel includes a connector that defines an outlet lumen therethrough, where the outlet lumen is in fluid communication with the interior of the barrel. The interior of the barrel is defined by the open proximal end, the distal end, and the first inner wall. The syringe includes a plunger having a proximal end and a distal end, the distal end of which is disposed within the interior of the barrel. The plunger is selectively translatable within the interior of the barrel along its axis. A plunger stopper is coupled to the distal end of the plunger. The plunger stopper has a distal end surface facing the distal end of the barrel. An integral, single-structure floating stopper is oriented within the interior of the barrel and is translatable between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall that defines a stopper lumen that is in open communication with its first axial end. The second axial end of the drum-shaped sidewall is joined to the circumferential base of a dome-shaped diaphragm defining a vertex by an intermediate annular flexible hinge. The diaphragm wall forming the diaphragm has a first side and a second side that are in communication with the stopper lumen. The diaphragm wall defines a central slit that penetrates both its first side and its second side at the vertex. The diaphragm wall of the dome-shaped diaphragm forms a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state, where the vertex is closer to the first axial end of the drum-shaped sidewall, and opens the central slit when the diaphragm buckles under tension in its radial dimension and is in a second state, where the vertex is further away from the first axial end of the drum-shaped sidewall. The open central slit allows pressurized fluid to flow out of the second side of the diaphragm from the stopper lumen, where the buckling of the diaphragm wall is caused only by a pressure differential generated by a fluid pressure in the stopper lumen on the first side being higher than a fluid pressure on its second side, and the diaphragm wall has no physical contact with any other structure within the syringe. A primary fluid chamber is defined within the interior of the barrel between the diaphragm of the floating stopper and the outlet lumen. The primary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume of the primary fluid chamber is selectively variable by translation of the plunger. A secondary fluid chamber is defined within the interior of the barrel between the distal end surface of the plunger stopper and the diaphragm of the floating stopper; the secondary fluid chamber is in fluid communication with the central slit of the diaphragm. The volume and fluid pressure within the secondary fluid chamber are selectively variable by translation of the plunger. When the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger draws fluid into or dispenses fluid out of the primary chamber only via the outlet lumen. When the fluid pressure differential within the secondary fluid chamber and the stopper lumen is increased enough to cause the wall of the dome-shaped diaphragm to buckle to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen such that further translation of the plunger toward the distal end of the barrel dispenses fluid out of the secondary chamber via the outlet lumen.

[0015] Another aspect of the present disclosure relates to a syringe that includes a generally cylindrical barrel that defines a first inner wall. The barrel has an open proximal end and a distal end, wherein the distal end of the barrel includes a connector that defines an outlet lumen therethrough. The outlet lumen is in fluid communication with the interior of the barrel; wherein the interior is defined by the open proximal end, the distal end, and the first inner wall of the barrel. The syringe includes a plunger having a proximal end and a distal end, wherein its distal end is disposed within the interior of the barrel. The plunger is selectively translatable within the interior of the barrel along its barrel axis. A plunger plug is coupled to the distal end of the plunger, and the plunger plug has a distal end surface facing the distal end of the barrel. An integral, single-structure floating plug is oriented within the interior of the barrel and is translatable between the plunger plug and the distal end of the barrel. The floating plug has a drum-shaped sidewall that defines a plug lumen that is in open communication with its first axial end. The second axial end of the drum-shaped sidewall is joined to the circumferential base of a dome-shaped diaphragm that defines a vertex. The diaphragm wall forming the diaphragm has a first face in communication with the plug lumen and a second face in an opposed orientation to the distal end of the barrel. The diaphragm wall defines a central slit that penetrates both its first and second faces at the vertex. The floating plug also defines a skirt having a first axial face and a second axial face, the first axial face being concentrically joined to the second face of the diaphragm wall by an annular skirt hinge that surrounds the central slit of the diaphragm wall, and the second axial face projecting from the skirt hinge in an orientation opposed to the distal end of the barrel. The diaphragm wall of the dome-shaped diaphragm forms a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state, wherein the vertex is closer to the first axial end of the drum-shaped sidewall, and opens the central slit when buckled under tension in its radial dimension and is in a second state, wherein the vertex is further away from the first axial end of the drum-shaped sidewall. The open central slit allows pressurized fluid to flow out of the second face of the diaphragm from the plug lumen, wherein the buckling of the diaphragm wall is caused only by a pressure differential generated by a fluid pressure in the plug lumen on the first face being higher than the fluid pressure on its second face, and the diaphragm wall has no physical contact with any other structure within the syringe. A primary fluid chamber is within the interior of the barrel and is defined between the diaphragm of the floating plug and the outlet lumen. The primary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume of the primary fluid chamber is selectively variable by translation of the plunger. A secondary fluid chamber is within the interior of the barrel and is defined between the distal end surface of the plunger plug and the diaphragm of the floating plug. The secondary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume and fluid pressure within the secondary fluid chamber can be selectively changed by translation of the plunger. When the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger draws fluid into the primary chamber or dispenses fluid out of the primary chamber only via the outlet lumen.When the fluid pressure difference in the secondary fluid chamber and the plug inner cavity is increased enough to cause the wall of the dome-shaped diaphragm to buckle into its second state and open the central slit of the diaphragm, the skirt folds or pivots around the annular skirt hinge towards the second face of the diaphragm wall, and the secondary fluid chamber is in fluid communication with the outlet lumen. Further translation of the plunger towards the distal end of the barrel distributes the fluid out of the secondary chamber via the outlet lumen.

[0016] The corresponding features of the aspects and exemplary embodiments of the present disclosure described herein can be applied jointly or separately in any combination or sub-combination. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0018] Figure 1 is a cross-sectional view of an embodiment of a dual-chamber syringe, in which each of the primary chamber and the secondary chamber contains fluid and is isolated from each other by a floating plug;

[0019] Figure 2 is Figure 1 a detailed cross-sectional view of the syringe, showing the dispensing of fluid from the primary chamber, where the floating plug isolates the fluid in the secondary chamber;

[0020] Figure 3 is Figure 1 a detailed cross-sectional view of the syringe, dispensing fluid from the secondary chamber through the floating plug;

[0021] Figure 4 is a cross-sectional view of another embodiment of a dual-chamber syringe, in which its secondary chamber contains fluid;

[0022] Figure 5 is Figure 4 an enlarged partial cross-sectional view of the syringe;

[0023] Figure 6 is Figure 4 an enlarged partial cross-sectional view of the syringe after dispensing fluid from the secondary chamber;

[0024] Figures 7 to 10 are illustrative sequential steps, respectively showing the aspiration and dispensing / infusion of fluid (such as a drug) in the primary chamber, followed by the dispensing of fluid from the secondary chamber.

[0025] For ease of understanding, the same reference numerals are used, where possible, to denote the same elements common to the drawings. The drawings are not drawn to scale. DETAILED DESCRIPTION

[0026] Many aspects of the disclosed embodiments of the dual-chamber syringe facilitate selective drug mixing, metering, and administration via a catheter or other vascular access device (VAD), as well as pre- or post-catheter administration flushing with a single syringe instrument. Generally, in each disclosed embodiment, the syringe includes a generally cylindrical barrel that defines a first inner wall. The barrel has an open proximal end and a distal end; the distal end of the barrel includes a connector, such as a Luer connector, that defines an outlet lumen therethrough. The outlet lumen is in fluid communication with the interior of the barrel. The interior of the barrel is defined by its open proximal end, distal end, and first inner wall. A plunger has a distal end, and a plunger stopper is disposed within the interior of the barrel; the plunger is selectively translatable within the interior of the barrel. An integral, single-structure floating stopper is oriented within the interior of the barrel and is translatable between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall that defines a stopper lumen that is open to communication with its first axial end. The second axial end of the drum-shaped sidewall is joined to the circumferential base of a dome-shaped diaphragm that defines a vertex. The diaphragm wall that forms the diaphragm has a first face and a second face that are in communication with the stopper lumen. The diaphragm wall also defines a central slit that penetrates both its first and second faces at the vertex. The diaphragm wall forms a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state, and opens the central slit when the diaphragm buckles (i.e., flips) under tension in its radial dimension to a second state. When the central slit is open, it allows pressurized fluid to flow out of the second face of the diaphragm from the stopper lumen. The buckling of the diaphragm wall is caused only by a pressure differential created by fluid pressure in the stopper lumen on its first face being higher than the fluid pressure on its second face, and the diaphragm wall has no physical contact with any other structure within the syringe. The pressure differential is created by translating the plunger toward the distal end of the barrel.

[0027] The floating stopper divides the interior of the barrel into a primary fluid chamber and a secondary fluid chamber, with the primary fluid chamber defined between itself and the distal end of the barrel, and the secondary fluid chamber defined between itself and the plunger stopper. When the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger only draws fluid into or dispenses fluid out of the primary chamber via the outlet lumen. When the pressure differential between the secondary fluid chamber and the stopper lumen is increased enough to cause the wall of the dome-shaped diaphragm to buckle or flip to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen such that further translation of the plunger toward the distal end of the barrel dispenses fluid out of the secondary chamber via the outlet lumen.

[0028] The isolated secondary chamber configuration advantageously facilitates the use of pre-packaged drugs or flush solutions in the chamber, whereby a clinician can aspirate and dispense a medicament with an empty primary chamber in a single plunger stroke and thereafter immediately deliver a pre-packaged flush solution from the secondary chamber without the need to manipulate an additional plunger, manual valve, or lock. In other embodiments, the syringe disclosed herein is used as a drug mixing syringe, with a powdered drug pre-packaged in the primary chamber and a diluent pre-packaged in the secondary chamber. In some embodiments, a single forward stroke of the single plunger of the syringe automatically delivers or infuses the flush solution following the drug contained in the primary chamber, sequentially into the VAD.

[0029] In the present disclosure, the following convention is followed, where the distal end of the device is the end that is closest to the patient, e.g., for delivering one or more drugs to the patient, and the proximal end of the device is the end that is away from the patient and closest to the clinician or other healthcare practitioner. With respect to the terms used in the present disclosure, the following definitions are provided.

[0030] As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0031] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way of attaching syringes, catheters, hubbed needles, I.V. tubing, etc. to each other. The Luer connector consists of male and female interlocking tubes that are slightly tapered so that they can be held together better even by a simple press / twist fit. The Luer connector may optionally include an additional threaded outer rim to make it even more secure. The male end of the Luer connector is associated with a flush syringe and can be interlocked and connected to the female end located on a vascular access device (VAD). The Luer connector also has: a distal end channel that releasably attaches the Luer connector to the hub of the VAD; and a proximal end channel that releasably attaches the Luer connector to the barrel of the syringe.

[0032] As used herein, ISO80369-7:2016 defines the specifications for standard luer connectors, including a 6% taper between the distal end and the proximal end. The male standard luer connector increases from the open distal end to the proximal end. The female standard luer connector decreases from the open proximal end to the distal end. According to ISO80369-7:2016, the outer cross-sectional diameter of the male standard luer connector measured at 0.75 mm from the distal end of the tip is between 3.970 mm and 4.072 mm. The length of the male standard luer cone is between 7.500 mm and 10.500 mm. The outer cross-sectional diameter measured at 7.500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm. The phrases "male standard luer connector" and "female standard luer connector" as used herein shall refer to connectors having the dimensions described in ISO80369-7, which is incorporated herein by reference in its entirety.

[0033] As will be readily appreciated by those skilled in the relevant art, although descriptive terms such as "tip", "hub", "thread", "projection / insert", "tab", "ramp", "wall", "top", "side", "bottom", etc. are used in this specification for ease of understanding, they are not intended to limit any components that can be used in combination or alone, or the various aspects of the embodiments of the present disclosure that require a specific spatial orientation for implementation.

[0034] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of the construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in many ways.

[0035] The matters illustrated in this description are to assist in a comprehensive understanding of the exemplary embodiments of the present disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. Additionally, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

[0036] In an exemplary implementation of an embodiment of the present disclosure, the barrel of the syringe includes a distal end having a needleless connection portion. In one or more embodiments, the needleless connection portion includes all combinations of at least one thread and other features to enable it to interact with a corresponding one or more threads of a corresponding connector.

[0037] According to further exemplary embodiments of the present disclosure, the configuration of the structural elements constituting the needleless connector includes a collar protruding from the distal end of the barrel, the collar including at least one thread for connection to a corresponding one or more threads of a corresponding connector. According to other exemplary embodiments of the present disclosure, the syringe includes a needle-type connector for aspirating a drug from a vial, rather than a needleless connector.

[0038] According to still other exemplary embodiments of the present disclosure, the collar or the needleless connector can be bent or elastically deformed to allow for better interference fit compliance with the corresponding connector.

[0039] According to still other exemplary embodiments of the present disclosure, the needleless connector can include: an internal thread sized and threaded to engage with a standard ISO594-2 type male fitting; and / or an external thread sized and threaded to engage with a standard ISO594-2 type female fitting. An example of an ISO594-2 type fitting is a Q-style fitting. According to still other exemplary embodiments of the present disclosure, the needleless connector can be used together with a needle-type connector for aspirating a drug from a vial.

[0040] In one or more embodiments, the female connector can be selected from the group consisting essentially of the following options: a needle-type connector (for direct injection into a patient or insertion into a drug vial to aspirate a drug dose therefrom), a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from 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. In one or more embodiments, the male connector can be an intravenous tube end or a stopcock.

[0041] Now referring to the drawings, in Figures 1 to 3A first aspect of the present disclosure is shown, wherein the syringe 20 includes a generally cylindrical barrel 22 that defines an open proximal end 24 and a distal end 26. The distal end 26 of the barrel 22 includes a luer connector 28 that defines an outlet lumen 30 for attachment to and fluid communication with various associated VAD connectors (not shown). The interior of the barrel 22 is generally defined and bounded by its inner sidewall 32, the open proximal end 24, and its distal end 26. The outlet lumen 30 is in fluid communication with the interior of the barrel. The plunger 34 is selectively translatable within the interior of the barrel. The plunger 34 has a distal end 36 with external threads 38 for coupling to a plunger stopper 40 by mating with internal threads 42 formed in the stopper. The mating external threads 38 and internal threads 42 together include connection features for removably or non-removably coupling the plunger 34 and the plunger stopper 40. Alternatively, in one or more embodiments, the connection features couple the plunger 34 and the plunger stopper 40 by way of an interference fit. In one or more embodiments, the connection features couple the plunger 34 and the plunger stopper 40 by way of a snap fit. In one or more embodiments, the connection features couple the plunger 34 and the plunger stopper 40 by way of a twist-lock fit. In one or more embodiments, the connection features couple the plunger 34 and the plunger stopper 40 by way of sonic welding or a medical-grade adhesive. In one or more embodiments, the plunger stopper 40 is integrally formed to the distal end 36 of the plunger 34. The plunger stopper 40 includes radially oriented ribs 43 and a distal end 44 that faces the distal end 26 of the syringe barrel 22. The distal end 44 of the plunger stopper 40 has an outwardly conical shape. In one or more embodiments, the distal end 44 has a frustoconical shape.

[0042] An integral, single-structure floating stopper 46 is oriented within the interior of the barrel and is translatable between the plunger stopper 40 and the distal end 26 of the syringe barrel 22. The floating stopper 46 has a drum-shaped sidewall 48 that has a first axial end 50 facing the plunger stopper 40, a second axial end 52 facing the distal end 26 of the syringe barrel 22, and an internal cavity 54 that is in open communication with its first axial end 50. The second axial end 52 of the drum-shaped sidewall 48 is joined to the circumferential base of a dome-shaped diaphragm 58 by an intervening annular flexible hinge 56. The wall 59 that forms the diaphragm 58 has a first face 60 that forms the apex 61 of the dome and is in communication with the internal cavity 54. The diaphragm wall 59 that forms the diaphragm has a second face 62 that is opposite its first face 60. In Figures 1 to 3In an embodiment, the wall thickness of the dome-shaped diaphragm 58 increases from its base at the hinge 56 to its apex 61. In other embodiments, the wall thickness of the dome-shaped diaphragm is uniform. The dome-shaped diaphragm 58 defines a central slit 64 between a third separable surface 66 and a fourth separable surface 68 that are oriented meridionally in its wall 59. The central slit 64 penetrates both its first surface 60 and its second surface 62 at the apex 61. The first surface 60 of the diaphragm 59 defines a notch 70 that diverges outwardly from the central slit 64 toward the first axial end 50 of the floating plug 46. In some embodiments, the floating plug 46 comprises a molded elastomeric material such as isoprene rubber.

[0043] The floating plug 46 divides the interior of the syringe barrel 22 into a primary fluid chamber 72 and a secondary fluid chamber 74, with the primary fluid chamber 72 defined between itself and the distal end 26 of the barrel; the secondary fluid chamber 74 is defined between itself and the plunger plug 40. Translation of the plunger 34 creates a pressure differential P on the floating plug 46, where withdrawing the plunger translates the floating plug toward the proximal end 24 of the syringe barrel 22. Conversely, advancing the plunger 34 translates the floating plug 46 toward the distal end 26 of the syringe barrel 22. When the central slit 64 of the dome-shaped diaphragm 58 is closed, the secondary fluid chamber 74 is isolated from the outlet lumen 30, such that translation of the plunger 34 draws fluid into or dispenses fluid from the primary chamber 72 only via the outlet lumen 30.

[0044] The diaphragm wall 59 of the dome-shaped diaphragm 58 forms a bistable valve; when the diaphragm is in a first, default, relaxed state, the valve closes the central slit 64 by compression in its meridional dimension ( Figure 2 dashed line C), where its apex 61 is closer to the first axial end 50 of the drum-shaped sidewall 48. The dome-shaped diaphragm 58 remains in its relaxed, closed state unless and until it buckles and extends under tension in its meridional dimension (i.e., flips as shown by Figure 3 dashed line E), into a second state where its apex 61 is further away from the first axial end 50 of the drum-shaped sidewall 48. When the dome-shaped diaphragm 58 is in its second buckled state, its central slit 64 is open, allowing fluid to flow out of the secondary chamber 74 and out of its second surface 62 through the plug lumen 54. Thereafter, the fluid flows through the primary chamber 72 such that it is dispensed or expelled through the outlet lumen 30.

[0045] Buckling or flipping of the wall 59 of the dome-shaped diaphragm 58 is caused only by applying a sufficiently high buckling fluid pressure differential P on the floating plug 46 by pressing and translating the plunger 34 toward the distal end 26 of the barrel 22 B When the plunger 34 is pressed with sufficient force to exceed the buckling fluid pressure differential level P within the lumen 54 of the floating plug 46 on the first surface 60 of the dome-shaped diaphragm 58 BWhen, its diaphragm wall 59 buckles into Figure 3 the second state shown in, and the diaphragm wall has no physical contact with any other structure within the syringe 20. When the pressure difference P on the first face 60 drops below the buckling pressure difference P B below, the domed plug 58 relaxes to its first state, closing the central slit 64, thereby reclosing the bistable valve and re-isolating the secondary chamber 74 from the primary chamber 72. In some embodiments, the buckling pressure difference P B is greater than approximately 30 pounds per square inch (2.07 bar).

[0046] In one or more embodiments of the syringe 20, the primary chamber 72 is pre-filled or filled in situ with the desired medicament. In one or more embodiments, the secondary chamber 74 is pre-filled with a desired amount of saline flush fluid. In one or more embodiments, the secondary chamber 74 is filled with the desired medicament. In one or more embodiments, both the primary chamber 72 and the secondary chamber 74 are filled with the desired medicament. In one or more embodiments, both the primary chamber 72 and the secondary chamber 74 are filled with a desired amount of saline flush fluid. In one or more embodiments, during or after the assembly of the syringe 20, the primary chamber 72 and / or the secondary chamber 74 are pre-filled with fluid using a sterile filling method. In some embodiments, the connector 28 and its outlet lumen 30 are capped (not shown) to prevent fluid leakage from the syringe 20. In some applications, the syringe 20 having the capped connector 28 is used to reconstitute a powdered medicament that has been pre-filled in the primary chamber 72 by dispersing a pre-filled diluent stored in the secondary chamber 74 into the primary chamber before opening the cap of the connector. In other applications, the primary chamber 72 is used to aspirate and dispense the drug into the VAD, and then the VAD is flushed with a flush solution stored in the secondary chamber 74.

[0047] Another aspect of the present disclosure is in Figures 4 to 10is shown, wherein the syringe 80 includes a generally cylindrical barrel 82 that defines an open proximal end 84 and a distal end 86. The distal end 86 of the barrel 82 includes a threaded Luer connector 88 that defines an outlet lumen 90 for attachment to and fluid communication with various associated VAD connectors (not shown). The interior of the barrel 82 is generally defined and bounded by its inner sidewall 92, the open proximal end 84, and its distal end 86. The outlet lumen 90 is in fluid communication with the interior of the barrel. A plunger 94 is selectively translatable within the interior of the barrel. The plunger 94 has a distal end 95 that is coupled to a plunger stopper 96 by connector features of the type previously described with respect to the syringe 20 embodiment. The plunger stopper 90 includes radially oriented ribs 97 and a distal end 98 that faces the distal end 86 of the syringe barrel 82. The distal end 98 of the plunger stopper 96 has an outwardly conical shape. In one or more embodiments, the distal end 98 has a frustoconical shape.

[0048] The integral, single-structure floating stopper 100 is oriented within the interior of the barrel and is translatable between the plunger stopper 96 and the distal end 86 of the syringe barrel 82. The floating stopper 100 has a drum-shaped sidewall 102 that has radially ribs 103, a first axial end 104 that faces the plunger stopper 96, a lumen 106 that is in open communication with its first axial end, and a second axial end 108 that faces the distal end 86 of the syringe barrel 82. The second axial end 108 of the drum-shaped sidewall 102 is joined to the circumferential base of a dome-shaped diaphragm 110 that defines an apex 112. The wall 113 that forms the diaphragm 110 has a first face 114 that is in communication with the lumen 106 and a second face 116 that is opposite its first face 114 and that defines the apex 112. The second face 116 is in an opposed orientation to the distal end 86 of the syringe barrel 82. In Figures 4 to 6 embodiments, the thickness of the wall 113 of the dome-shaped diaphragm 110 increases from its base at the second axial end 108 of the floating stopper 100 to the apex 112. In other embodiments, the thickness of the wall 113 of the dome-shaped diaphragm is uniform. The dome-shaped diaphragm 110 has a third separable face 118 and a fourth separable face 120 that are radially oriented in its wall 113 and that define a central slit 122 therebetween. The central slit 122 is radially oriented and penetrates both the first face 60 and the second face 62 of the dome-shaped diaphragm 110 at the apex 112.

[0049] The floating plug 110 further includes a generally annular flexible skirt hinge 124 that is coupled to the second face 116 of the dome-shaped diaphragm 110 and surrounds the central slit 122. The frustoconical skirt 126 has a first axial face 127 of smaller diameter and a second axial face 128 of larger diameter. The first axial face 127 is coupled to the skirt hinge 124, and the second axial face 128 projects away from the skirt hinge and is in an opposing orientation to the distal end 86 of the syringe barrel 82. Refer to Figure 6 , the skirt 126 is pivotable about the skirt hinge 124 and is enabled to fold into a recess 130 surrounding the skirt hinge towards the second face 116 of the dome-shaped diaphragm 110. In some other embodiments, the skirt includes a profile different from the frustoconical profile. In some other embodiments, the second face of the dome-shaped diaphragm does not define a recess for receiving the skirt. In some embodiments, the floating plug 100 includes a molded elastomeric material such as isoprene rubber.

[0050] The floating plug 100 divides the interior of the syringe barrel 82 into a primary fluid chamber 140 and a secondary fluid chamber 142. The primary fluid chamber 140 is defined between itself and the distal end 86 of the barrel; the secondary fluid chamber 142 is defined between itself and the plunger plug 96. Translation of the plunger 94 creates a pressure differential P on the floating plug 100, where withdrawing the plunger translates the floating plug towards the proximal end 84 of the syringe barrel 82. Conversely, advancing the plunger 94 translates the floating plug 100 towards the distal end 86 of the syringe barrel 82. When the central slit 122 of the dome-shaped diaphragm 110 is closed, the secondary fluid chamber 142 is isolated from the outlet lumen 90, such that translation of the plunger 94 only draws fluid into the primary chamber 140 or dispenses fluid out of the primary chamber via the outlet lumen 90.

[0051] The diaphragm wall 113 of the dome-shaped diaphragm 110 forms a bistable valve, conceptually similar to Figures 1 to 3 the bistable valve of the dome-shaped diaphragm 58 of the syringe 20. In Figures 4 to 10 the embodiment, when the dome-shaped diaphragm 110 is in a first default relaxed state where its apex 112 is closer to the first axial end 104 of the drum-shaped sidewall 102, the bistable valve closes the central slit 124 by compressing the dome-shaped diaphragm 110 in its meridional dimension. The dome-shaped diaphragm 110 remains in its relaxed, closed state unless ( Figure 5 ) and until it buckles and extends under tension in its meridional dimension (i.e., flips, in Figure 6As shown in [FIGURE], in the second state, its vertex 112 is further away from the first axial end 104 of the drum-shaped sidewall 102. When the dome-shaped diaphragm 110 is in its second buckled state, its central slit 122 opens, allowing fluid to flow out of the secondary chamber 142 and out of its second face 116 through the plug inner cavity 106. Thereafter, the fluid flows through the primary chamber 140, and is thus dispensed or discharged through the outlet lumen 90. The buckling and extension of the dome-shaped diaphragm 110 into its second state also contributes to the folding of the skirt 126 towards the second face 116 and the recess 130.

[0052] The buckling or flipping of the wall 113 of the dome-shaped diaphragm 110 is caused only by applying a sufficiently high buckling fluid pressure difference P on the floating plug 100 by pressing the plunger 94 towards the distal end 86 of the barrel 82 and translating it towards the same. B When the plunger 94 is pressed with sufficient force to exceed the buckling fluid pressure difference level P within the inner cavity 106 of the floating plug 100 on the first face 114 of the dome-shaped diaphragm 110 B its diaphragm wall 113 buckles into the Figure 6 second state shown in [FIGURE], and the diaphragm wall makes no physical contact with any other structure within the syringe 80. When the pressure difference P on the first face 114 drops below the buckling pressure difference P B the dome-shaped plug 110 relaxes to its first state, closing the central slit 122, thereby reclosing the bistable valve and re-isolating the secondary chamber 142 from the first chamber 140, unless otherwise blocked by a barrel protrusion 132 as shown in Figure 6 [FIGURE]. In some embodiments, the buckling pressure difference P B is greater than about 30 pounds per square inch (2.07 bar).

[0053] Referring to Figure 5 and Figure 6 [FIGURE], the distal end 86 of the syringe barrel 82 forms a generally tubular barrel protrusion 132 that projects inwardly towards the dome-shaped diaphragm 110 of the floating plug 100 and is coaxially aligned with the axis of the barrel and the central slit 122. The barrel protrusion 132 has a generally frustoconical tubular profile with a tapered sidewall 133 that defines one or more through notches 134 for fluid communication between the primary chamber 140 and the fluid passage 136 within the barrel protrusion. The fluid passage 136 formed in the barrel protrusion 132 facilitates fluid communication between the primary chamber 140 and the outlet lumen 90, through one or more through notches 134 circumferentially around the sidewall 133 and axially through the blunt end 138. In other embodiments, the tubular barrel protrusion 132 defines other profiles.

[0054] Figure 4 、 Figure 5 and Figure 6Shows the interaction of the dome-shaped diaphragm 110, skirt 126, and barrel projection 132 of syringe 80, where the secondary fluid chamber 142 contains fluid and the primary fluid chamber 140 contains at most the residual fluid between the floating plug 100 and the distal end 86 of the syringe barrel 82. In Figure 5 , the dome-shaped diaphragm 110 is in its first relaxed state with its central slit 122 closed. The second axial face 128 of the skirt 126 projects axially towards the distal end 86 of the syringe barrel 82 and abuts against the distal end 86. In this position, the skirt 126 prevents the barrel projection 132 from entering the central slit 132 of the diaphragm 110. Any fluid in the primary fluid chamber 140 communicates with the through-notch 134 and can flow through the fluid passage 136 of the barrel projection 132 and out of the outlet lumen 90 of the syringe 80. In contrast, any fluid in the secondary fluid chamber 142 cannot pass through the closed central slit 122 and is isolated from the outlet lumen 90. When the dome-shaped diaphragm 110 is in its first relaxed state with its central slit 122 closed, the pressure in the secondary fluid chamber 142 is below the buckling pressure required to buckle or flip the diaphragm to its second state. Refer to Figure 4 and Figure 6 , when the plunger 94 is advanced forward with sufficient force to raise the pressure in the secondary fluid chamber 142 to the buckling pressure P of the floating plug 100 B or higher, the dome-shaped diaphragm 110 buckles or flips to its second state, opening the central slit 122 and rotating / folding the skirt 126 about the skirt hinge 124 of the skirt. As the plunger 94 is further advanced forward, the barrel projection 132 enters the now open central slit 122, allowing the fluid in the secondary fluid chamber 142 to flow through the fluid passage 136 and the outlet lumen 90. Further advancement of the plunger 94 discharges the fluid from the secondary chamber 142 through the outlet lumen. The entry of the barrel projection 132 into the central slit 122 effectively prevents the dome-shaped diaphragm from fully relaxing back to its initial state. Instead, the diaphragm wall 113 flexibly conforms to the abutting contact with the tapered sidewall 133 of the barrel projection 132. Thus, the subsequent decrease in the forward force and pressure applied to the plunger 94 can be reduced to below the buckling pressure P B while still discharging fluid from the secondary chamber 142.

[0055] In one or more embodiments, the primary chamber 140 is pre-filled or filled in situ with the desired medicament. In one or more embodiments, the secondary chamber 142 is pre-filled with a desired amount of saline flush fluid. In one or more embodiments, the secondary chamber 142 is filled with the desired medicament. In one or more embodiments, both the primary chamber 140 and the secondary chamber 142 are filled with the desired medicament. In one or more embodiments, both the primary chamber 140 and the secondary chamber 142 are filled with a desired amount of saline flush fluid. In one or more embodiments, during or after the assembly of the syringe 80, the primary chamber 140 and / or the secondary chamber 142 are pre-filled with fluid using a sterile filling method. In some embodiments, the connector 88 and its outlet lumen 90 are capped (not shown) to prevent fluid leakage from the syringe 80. In some applications, the syringe 80 with the capped connector 88 is used to reconstitute a powdered medicament that has been pre-filled in the primary chamber 140 by dispersing a pre-filled diluent stored in the secondary chamber 142 into the primary chamber before opening the cap of the connector.

[0056] In other applications, such as Figures 4 to 10 shown in, the drug is aspirated into the primary chamber 140 and dispensed into the VAD, and then the VAD is flushed with a flush solution pre-filled in the secondary chamber 142 during the assembly of the syringe 80. A removable C-shaped collar 144 is applied around the exposed portion of the plunger 94 to inhibit its inadvertent forward movement and the inadvertent discharge of the flush solution from the syringe 80. The collar 144 is removed by a healthcare management professional prior to using the syringe.

[0057] Figures 7 to 10 The functional operation of the syringe 80 is depicted, where the secondary fluid chamber 142 is pre-filled with a fluid, such as a flush fluid, while the primary chamber 140 is empty. In Figure 7 the healthcare management professional removes the collar 144, thereby allowing the plunger 94 to be manipulated throughout its full range of motion. The extended skirt 126 of the floating plug 100 prevents the barrel projection 132 from inserting into the dome-shaped diaphragm 110. Although not shown in the figure, the healthcare professional attaches a needle to the Luer connector 88 for aspirating the desired medicament from a drug vial or other container into the empty primary chamber 140 of the syringe 80. In Figure 8 the plunger 94 is retracted in the direction of arrow R, which aspirates the medicament from the vial into the primary fluid chamber 140. By advancing the plunger 94 in the direction of arrow A, the medicament is infused from the primary chamber 140 into the previously flushed VAD of the patient with sufficient pressure below the buckling pressure of the dome-shaped diaphragm 110 to empty the primary chamber while maintaining the diaphragm in its first relaxed state ( Figure 5). After administering the agent to the patient, the plunger rod 94 is advanced forward with a sufficient force A to exceed the buckling pressure P of the dome-shaped diaphragm 110 B , and the VAD is flushed with a flushing solution (such as saline or heparin) pre-packaged in the secondary chamber 142. After completing the flushing procedure, the syringe 80 is then withdrawn from the VAD.

[0058] The syringe embodiments disclosed herein are constructed of medical-grade materials known to those skilled in the art. In some embodiments, the described barrel, plunger, and shaft are made of polypropylene polymer. The seal is made of fiber-filled polytetrafluoroethylene (PTFE) polymer. The stopper is made of polyisoprene polymer.

[0059] Embodiments

[0060] Example (a). A syringe comprising a generally cylindrical barrel that defines a first inner wall, the barrel having an open proximal end and a distal end, the distal end of the barrel including a connector that defines an outlet lumen therethrough, the outlet lumen being in fluid communication with the interior of the barrel, the interior being defined by the open proximal end, distal end, and first inner wall of the barrel; a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the interior of the barrel and being selectively translatable along its axis within the interior of the barrel; a plunger plug coupled to the distal end of the plunger, the plunger plug having a distal end surface facing the distal end of the barrel; an integral, single - structure floating plug oriented within the interior of the barrel and translatable between the plunger plug and the distal end of the barrel, the floating plug having a drum - shaped sidewall that defines a plug lumen that is in open communication with its first axial end, the second axial end of the drum - shaped sidewall being joined to the circumferential base of a dome - shaped diaphragm that defines a vertex, the diaphragm wall of the dome - shaped diaphragm having a first face and a second face that are in communication with the plug lumen, the diaphragm wall further defining a central slit that penetrates both its first and second faces at the vertex, the diaphragm wall of the dome - shaped diaphragm forming a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state and opens the central slit when the diaphragm buckles under tension in the radial dimension and is in a second state, the opened central slit allowing pressurized fluid to flow out of the second face of the diaphragm from the plug lumen, wherein the buckling of the diaphragm wall is caused only by a pressure difference resulting from the fluid pressure in the plug lumen being higher on the first face than the fluid pressure on the second face, and the diaphragm wall has no physical contact with any other structure within the syringe; a primary fluid chamber within the interior of the barrel, defined between the diaphragm of the floating plug and the outlet lumen, the primary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume of the primary fluid chamber being selectively variable by translation of the plunger; and a secondary fluid chamber within the interior of the barrel, defined between the distal end surface of the plunger plug and the diaphragm of the floating plug, the secondary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the secondary fluid chamber being selectively variable by translation of the plunger; wherein when the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger only draws fluid into or dispenses fluid out of the primary chamber via the outlet lumen;And wherein, when the fluid pressure difference in the secondary fluid chamber and the plug inner cavity is increased sufficiently to cause the wall of the dome-shaped diaphragm to buckle to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen such that further translation of the plunger towards the distal end of the barrel distributes fluid out of the secondary chamber via the outlet lumen.;

[0061] Example (b). The syringe according to example (a), further comprising a notch defined by a first face of the diaphragm wall that diverges outwardly from the central slit towards a first axial end of the floating plug.

[0062] Example (c). The syringe according to example (a), wherein the dome-shaped diaphragm buckles from its first relaxed state to its second state when a fluid pressure difference greater than about 30 pounds per square inch (2.07 bar) is applied in the plug inner cavity.

[0063] Example (d). The syringe according to example (a), wherein the floating plug further comprises a skirt having a first axial face and a second axial face, the first axial face being concentrically connected to a second face of the diaphragm wall by an annular skirt hinge that surrounds the central slit of the diaphragm wall, the second axial face projecting from the skirt hinge and being oriented opposite the distal end of the barrel such that buckling of the diaphragm wall to its second state causes the skirt to fold or pivot about the annular skirt hinge towards the second face of the diaphragm wall.

[0064] Example (e). The syringe according to example (d), further comprising a protrusion formed at the distal end of the barrel that projects inwardly towards the dome-shaped diaphragm of the floating plug, the protrusion being coaxial with the axis of the barrel and being received within the central slit when the diaphragm wall is in its second state.

[0065] Example (f). The syringe according to example (e), wherein the protrusion further comprises a blunt-ended tube in fluid communication with the outlet lumen of the connector.

[0066] Example (g). The syringe according to example (a), further comprising a protrusion formed at the distal end of the barrel that projects inwardly towards the dome-shaped diaphragm of the floating plug, the protrusion being coaxial with the axis of the barrel and being received within the central slit when the diaphragm wall is in its second state.

[0067] Example (h). The syringe according to example (a), further comprising a first face of the wall of the diaphragm defining the apex of the dome-shaped diaphragm.

[0068] Example (i). The syringe according to Example (a) further includes a second face of the septum wall defining a vertex of the dome-shaped septum.

[0069] Example (j). A syringe comprising a generally cylindrical barrel defining a first inner wall, the barrel having an open proximal end and a distal end, the distal end of the barrel including a connector defining an outlet lumen therethrough, the outlet lumen being in fluid communication with the interior of the barrel, the interior being defined by the open proximal end, the distal end, and the first inner wall of the barrel; a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the interior of the barrel and being selectively translatable along its axis within the interior of the barrel; a plunger plug coupled to the distal end of the plunger, the plunger plug having a distal end surface facing the distal end of the barrel; an integral, single-structure floating plug oriented within the interior of the barrel and translatable between the plunger plug and the distal end of the barrel, the floating plug having a drum-shaped sidewall defining a plug lumen opening into its first axial end, the second axial end of the drum-shaped sidewall being joined to the circumferential base of a dome-shaped diaphragm defining an apex by an intermediate annular flexible hinge, the diaphragm wall of the diaphragm having a first side in communication with the plug lumen and a second side, the diaphragm wall defining a central slit penetrating both its first and second sides at the apex; the diaphragm wall of the dome-shaped diaphragm forming a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state, wherein the apex is closer to the first axial end of the drum-shaped sidewall, and opens the central slit when the diaphragm buckles under tension in the radial dimension in a second state, wherein the apex is further away from the first axial end of the drum-shaped sidewall, the opened central slit allowing pressurized fluid to flow out of the second side of the diaphragm from the plug lumen, wherein the buckling of the diaphragm wall is caused only by a pressure differential resulting from a fluid pressure in the plug lumen on the first side being higher than the fluid pressure on its second side, and the diaphragm wall has no physical contact with any other structure within the syringe; a primary fluid chamber within the interior of the barrel, defined between the diaphragm of the floating plug and the outlet lumen, the primary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume of the primary fluid chamber being selectively variable by translation of the plunger; and a secondary fluid chamber within the interior of the barrel, defined between the distal end surface of the plunger plug and the diaphragm of the floating plug, the secondary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the secondary fluid chamber being selectively variable by translation of the plunger; wherein when the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger draws fluid into or dispenses fluid out of the primary chamber only via the outlet lumen;And wherein, when the fluid pressure difference in the secondary fluid chamber and the plug inner cavity is increased enough to cause the wall of the dome-shaped diaphragm to buckle to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen, such that further translation of the plunger toward the distal end of the barrel distributes fluid out of the secondary chamber via the outlet lumen.;

[0070] Embodiment (k). The syringe according to embodiment (j), further comprising a notch defined by a first face of the diaphragm wall that diverges outwardly from the central slit toward a first axial end of the floating plug.

[0071] Embodiment (l). The syringe according to embodiment (j), wherein when a fluid pressure difference greater than about 30 pounds per square inch (2.07 bar) is applied in the plug inner cavity, the dome-shaped diaphragm buckles from its first relaxed state to its second state.

[0072] Embodiment (m). The syringe according to embodiment (j), further comprising the diaphragm wall having an increasing thickness from the base to the apex of the dome-shaped diaphragm.

[0073] Embodiment (n). The syringe according to embodiment (j), further comprising a first face of the wall of the diaphragm defining the apex of the dome-shaped diaphragm.

[0074] Example (o). A syringe comprising a generally cylindrical barrel defining a first inner wall, the barrel having an open proximal end and a distal end, the distal end of the barrel including a connector defining an outlet lumen therethrough, the outlet lumen being in fluid communication with the interior of the barrel, the interior being defined by the open proximal end, distal end, and first inner wall of the barrel; a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the interior of the barrel and being selectively translatable along its barrel axis within the interior of the barrel; a plunger plug coupled to the distal end of the plunger, the plunger plug having a distal end surface facing the distal end of the barrel; an integral, single-structure floating plug oriented within the interior of the barrel and translatable between the plunger plug and the distal end of the barrel, the floating plug having a drum-shaped sidewall defining a plug lumen in open communication with its first axial end, the second axial end of the drum-shaped sidewall being joined to the circumferential base of a dome-shaped diaphragm defining a vertex, the diaphragm wall of the diaphragm having a first face in communication with the plug lumen and a second face in an orientation opposed to the distal end of the barrel, the diaphragm wall defining a central slit penetrating both its first and second faces at the vertex, the floating plug further defining a skirt having a first axial face and a second axial face, the first axial face being concentrically joined to the second face of the diaphragm wall by an annular skirt hinge surrounding the central slit of the diaphragm wall, the second axial face projecting from the skirt hinge in an orientation opposed to the distal end of the barrel, the diaphragm wall of the dome-shaped diaphragm forming a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state, wherein the vertex is closer to the first axial end of the drum-shaped sidewall, and opens the central slit when the diaphragm buckles under tension in its radial dimension into a second state, wherein the vertex is further away from the first axial end of the drum-shaped sidewall, the opened central slit allowing pressurized fluid to flow out of the second face of the diaphragm from the plug lumen, wherein the buckling of the diaphragm wall is caused only by a pressure differential resulting from a fluid pressure in the plug lumen on the first face being higher than the fluid pressure on its second face, and the diaphragm wall has no physical contact with any other structure within the syringe; a primary fluid chamber within the interior of the barrel, defined between the diaphragm of the floating plug and the outlet lumen, the primary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume of the primary fluid chamber being selectively variable by translation of the plunger;and a secondary fluid chamber, which is inside the barrel, defined between the distal end surface of the plunger plug and the diaphragm of the floating plug, the secondary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the secondary fluid chamber being selectively variable by translation of the plunger; wherein when the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger draws fluid into the primary chamber or dispenses fluid from the primary chamber only via the outlet lumen; and wherein when the fluid pressure differential between the secondary fluid chamber and the lumen of the plug is increased sufficiently to cause the wall of the dome-shaped diaphragm to buckle into its second state and open the central slit of the diaphragm, the skirt folds or pivots about the annular skirt hinge towards the second face of the diaphragm wall, and the secondary fluid chamber is in fluid communication with the outlet lumen such that further translation of the plunger towards the distal end of the barrel dispenses the fluid from the secondary fluid chamber via the outlet lumen.;

[0075] Example (p). The syringe according to Example (o), wherein when a fluid pressure differential greater than about 30 pounds per square inch (2.07 bar) is applied in the lumen of the plug, the dome-shaped diaphragm buckles from its first relaxed state to its second state.

[0076] Example (q). The syringe according to Example (o), wherein the skirt of the floating plug further includes a frustoconical skirt having a first axial face of a narrower diameter and a diverging second axial face, the first axial face being concentrically connected to the second face of the diaphragm wall by an annular skirt hinge that surrounds the central slit of the diaphragm wall, the second axial face protruding from the skirt hinge and being in an orientation opposite to the distal end of the barrel, such that buckling of the diaphragm wall into its second state folds or pivots the skirt about the annular skirt hinge towards the second face of the diaphragm wall.

[0077] Example (r). The syringe according to Example (q), further comprising a recess defined in the second face of the diaphragm wall for receiving the folded or pivoted skirt when the diaphragm wall buckles to its second state.

[0078] Example (s). The syringe according to Example (r), wherein when the diaphragm wall is in its first state, the skirt prevents contact between the central slit and the distal end of the barrel.

[0079] Example (t). The syringe according to Example (r) further includes a protrusion formed at the distal end of the barrel that protrudes inwardly toward the dome-shaped diaphragm of the floating plug, the protrusion being coaxial with the axis of the barrel, and when the diaphragm wall is in its second state, the protrusion is received within the central slit.

[0080] Example (u). The syringe according to Example (t), wherein the protrusion further includes a blunt-ended tube that is in fluid communication with the outlet lumen of the connector.

[0081] Example (v). The syringe according to Example (o) further includes a second face of the diaphragm wall that defines a recess for receiving a folded or pivoting skirt when the diaphragm wall buckles to its second state.

[0082] Example (w). The syringe according to Example (o), wherein when the diaphragm wall is in its first state, the skirt prevents contact between the central slit and the distal end of the barrel.

[0083] Example (x). The syringe according to Example (o) further includes a protrusion formed at the distal end of the barrel that protrudes inwardly toward the dome-shaped diaphragm of the floating plug, the protrusion being coaxial with the axis of the barrel, and when the diaphragm wall is in its second state, the protrusion is received within the central slit.

[0084] Example (y). The syringe according to Example (x), wherein the protrusion further includes a blunt-ended tube that is in fluid communication with the outlet lumen of the connector.

[0085] Example (z). The syringe according to Example (x) further includes a circumferential surface of the tube that defines a through-orifice for establishing fluid communication between the interior of the tube and the outlet lumen of the connector.

[0086] Example (aa). The syringe according to Example (o) further includes a second face of the diaphragm wall that defines the apex of the dome-shaped diaphragm.

[0087] As used herein, the terms "one embodiment", "certain embodiments", "various embodiments", "one or more embodiments", or "embodiment" mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, phrases such as "in one or more embodiments", "in certain embodiments", "in various embodiments", "in one embodiment", or "in an embodiment" that appear throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Moreover, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. Further, it will be understood that the language and terminology used herein are for the purpose of description and should not be regarded as limiting. As used herein, the terms "comprising", "including", or "having" and variations thereof mean to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless otherwise specified or limited, the terms "mounted", "connected", "supported", and "coupled" and variations thereof will be construed broadly; they include direct and indirect mounting, connection, support, and coupling. Moreover, "connected" and "coupled" are not limited to physical, mechanical, or electrical connection or coupling.

[0088] Although the present disclosure has been described with reference to embodiments, it is to be understood that these embodiments merely illustrate 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 present disclosure without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents. The appended claims are not limited to the construction details and component arrangements of the exemplary embodiments set forth in the specification or shown in the drawings.

Claims

1. A syringe, comprising: A generally cylindrical barrel that defines a first inner wall, the barrel having an open proximal end and a distal end, the distal end of the barrel including a connector that defines an outlet lumen therethrough, the outlet lumen being in fluid communication with the interior of the barrel, the interior being defined by the open proximal end, the distal end, and the first inner wall of the barrel; A plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the interior of the barrel and being selectively translatable along its axis within the interior of the barrel; A plunger plug coupled to the distal end of the plunger, the plunger plug having a distal end surface facing the distal end of the barrel; An integral, single - structure floating plug oriented within the interior of the barrel and translatable between the plunger plug and the distal end of the barrel, the floating plug having a drum - shaped sidewall that defines a plug lumen that is open - communicative with its first axial end, a second axial end of the drum - shaped sidewall being joined to a circumferential base of a dome - shaped diaphragm that defines a vertex, a diaphragm wall of the diaphragm having a first face and a second face that are in communication with the plug lumen, the diaphragm wall further defining a central slit that penetrates both its first and second faces at the vertex, the diaphragm wall of the dome - shaped diaphragm forming a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in a first relaxed state and opens the central slit when the diaphragm buckles under tension in the radial dimension to a second state, the opened central slit allowing pressurized fluid to flow out of the second face of the diaphragm from the plug lumen, wherein the buckling of the diaphragm wall is caused only by a pressure differential resulting from a fluid pressure in the plug lumen on the first face being higher than a fluid pressure on its second face, and the diaphragm wall has no physical contact with any other structure within the syringe; A primary fluid chamber within the interior of the barrel, defined between the diaphragm of the floating plug and the outlet lumen, the primary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume of the primary fluid chamber being selectively variable by translation of the plunger; And A secondary fluid chamber within the interior of the barrel, defined between the distal end surface of the plunger plug and the diaphragm of the floating plug, the secondary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the secondary fluid chamber being selectively variable by translation of the plunger; Wherein, when the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen such that translation of the plunger only draws fluid into or dispenses fluid out of the primary chamber via the outlet lumen; and Wherein, when the fluid pressure difference in the secondary fluid chamber and the inner cavity of the plug is increased enough to cause the wall of the dome-shaped diaphragm to buckle to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen, such that further translation of the plunger toward the distal end of the barrel distributes fluid out of the secondary chamber via the outlet lumen.

2. The syringe according to claim 1, further comprising a notch defined by a first face of the septum wall and diverging outwardly from the central slit towards a first axial end of the floating plug.

3. The syringe according to claim 1, wherein, When the fluid pressure difference applied in the inner cavity of the plug is greater than about 30 pounds per square inch (2.07 bar), the dome-shaped diaphragm buckles from its first relaxed state to its second state.

4. The syringe according to claim 1, wherein the floating plug further comprises a skirt having a first axial face and a second axial face, the first axial face being concentrically connected to a second face of the septum wall by an annular skirt hinge surrounding the central slit of the septum wall, the second axial face protruding from the skirt hinge and being oriented opposite to the distal end of the barrel, such that when the septum wall buckles to its second state, the skirt is folded or pivoted around the annular skirt hinge towards the second face of the septum wall.

5. The syringe according to claim 4, further comprising a protrusion formed at a distal end of the barrel and protruding inwardly towards a dome-shaped septum of the floating plug, the protrusion being coaxial with the axis of the barrel, and when the septum wall is in its second state, the protrusion is received within the central slit.

6. The syringe according to claim 5, wherein the protrusion further comprises a blunt-ended tube in fluid communication with an outlet lumen of the connector.

7. The syringe according to claim 1, further comprising a protrusion formed at a distal end of the barrel and protruding inwardly towards a dome-shaped septum of the floating plug, the protrusion being coaxial with the axis of the barrel, and when the septum wall is in its second state, the protrusion is received within the central slit.

8. The syringe according to claim 1, further comprising a first face of the wall of the septum defining a vertex of the dome-shaped septum.

9. The syringe according to claim 1, further comprising a second face of the wall of the septum defining the vertex of the dome-shaped septum.

10. A syringe, comprising: A generally cylindrical barrel that defines a first inner wall, the barrel having an open proximal end and a distal end, the distal end of the barrel including a connector that defines an outlet lumen therethrough, the outlet lumen being in fluid communication with the interior of the barrel, the interior being defined by the open proximal end, the distal end, and the first inner wall of the barrel; A plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the interior of the barrel and being selectively translatable along its axis within the interior of the barrel; A plunger plug coupled to the distal end of the plunger, the plunger plug having a distal end surface facing the distal end of the barrel; An integral, single-structure floating plug oriented within the interior of the barrel and translatable between the plunger plug and the distal end of the barrel, the floating plug having a drum-shaped sidewall that defines a plug inner cavity that is open in communication with its first axial end, the second axial end of the drum-shaped sidewall being joined to the circumferential base of a dome-shaped diaphragm that defines a vertex by means of an intervening annular flexible hinge, the diaphragm wall of the diaphragm having a first side in communication with the plug inner cavity and a second side, the diaphragm wall defining a central slit that penetrates both its first side and its second side at the vertex; The diaphragm wall of the dome-shaped diaphragm forms a bistable valve that closes the central slit by compression in its radial dimension when the diaphragm is in its first relaxed state, wherein the vertex is closer to the first axial end of the drum-shaped sidewall, and opens the central slit when the diaphragm buckles under tension in its radial dimension to its second state, wherein the vertex is further away from the first axial end of the drum-shaped sidewall, the opened central slit allowing pressurized fluid to flow out of the second side of the diaphragm from the plug inner cavity, wherein the buckling of the diaphragm wall is caused only by the pressure difference generated by the fluid pressure in the plug inner cavity on the first side being higher than the fluid pressure on its second side, and the diaphragm wall has no physical contact with any other structure within the syringe; A primary fluid chamber within the interior of the barrel, defined between the diaphragm of the floating plug and the outlet lumen, the primary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume of the primary fluid chamber being selectively variable by translation of the plunger; And A secondary fluid chamber, which is inside the cylinder, defined between the distal end surface of the plunger plug and the diaphragm of the floating plug. The secondary fluid chamber is in fluid communication with the central slit of the diaphragm. The volume and fluid pressure within the secondary fluid chamber can be selectively changed by the translation of the plunger; wherein when the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen, such that the translation of the plunger only sucks fluid into the primary chamber or distributes fluid out of the primary chamber via the outlet lumen; and wherein when the fluid pressure difference between the secondary fluid chamber and the inner lumen of the plug is increased enough to cause the wall of the dome-shaped diaphragm to buckle to its second state and open the central slit of the diaphragm, the secondary fluid chamber is in fluid communication with the outlet lumen, such that further translation of the plunger towards the distal end of the cylinder distributes fluid out of the secondary chamber via the outlet lumen.

11. The syringe according to claim 10, further comprising a notch defined in a first face of the septum wall and diverging outwardly from the central slit towards a first axial end of the floating plug.

12. The syringe according to claim 10, wherein When the fluid pressure difference applied in the inner lumen of the plug is greater than about 30 pounds per square inch (2.07 bar), the dome-shaped diaphragm buckles from its first relaxed state to its second state.

13. The syringe according to claim 10, further comprising the thickness of the septum wall increasing from a base to a vertex of the dome-shaped septum.

14. The syringe according to claim 10, further comprising a vertex of the dome-shaped septum defined in a first face of the septum wall.

15. A syringe comprising: A generally cylindrical cylinder that defines a first inner wall. The cylinder has an open proximal end and a distal end. The distal end of the cylinder includes a connector that defines an outlet lumen therethrough. The outlet lumen is in fluid communication with the interior of the cylinder, and the interior is defined by the open proximal end, the distal end, and the first inner wall of the cylinder; A plunger having a proximal end and a distal end. The distal end of the plunger is disposed inside the cylinder and is selectively translatable along its cylinder axis inside the cylinder; A plunger plug coupled to the distal end of the plunger. The plunger plug has a distal end surface facing the distal end of the cylinder; Integral, single - structured floating plug, the floating plug being oriented within the interior of the barrel and being translatable between the plunger plug and the distal end of the barrel. The floating plug has a drum - shaped sidewall that defines a plug inner cavity that is in open communication with its first axial end. The second axial end of the drum - shaped sidewall is joined to the circumferential base of a dome - shaped diaphragm that defines an apex. The diaphragm wall of the diaphragm has a first face in communication with the plug inner cavity and a second face, the second face being in an orientation opposite to the distal end of the barrel. The diaphragm wall defines a central slit that penetrates both its first and second faces at the apex. The floating plug further defines a skirt that has a first axial face and a second axial face. The first axial face is concentrically joined to the second face of the diaphragm wall by an annular skirt hinge that surrounds the central slit of the diaphragm wall. The second axial face projects from the skirt hinge and is in an orientation opposite to the distal end of the barrel. The diaphragm wall of the dome - shaped diaphragm forms a bistable valve. When the diaphragm is in a first relaxed state, the central slit is closed by compressing its radial dimension, where the apex is closer to the first axial end of the drum - shaped sidewall. And when the diaphragm buckles under tension in the radial dimension to be in a second state, the central slit is opened, where the apex is further away from the first axial end of the drum - shaped sidewall. The opened central slit allows pressurized fluid to flow out of the second face of the diaphragm from the plug inner cavity. The buckling of the diaphragm wall is caused only by the pressure difference generated by the fluid pressure in the plug inner cavity on the first face being higher than the fluid pressure on its second face, and the diaphragm wall has no physical contact with any other structure within the syringe; A primary fluid chamber that is within the interior of the barrel and is defined between the diaphragm of the floating plug and the outlet lumen. The primary fluid chamber is in fluid communication with the central slit of the diaphragm, and the volume of the primary fluid chamber can be selectively changed by the translation of the plunger; And A secondary fluid chamber that is within the interior of the barrel and is defined between the distal end surface of the plunger plug and the diaphragm of the floating plug. The secondary fluid chamber is in fluid communication with the central slit of the diaphragm, and the volume and fluid pressure within the secondary fluid chamber can be selectively changed by the translation of the plunger; wherein, when the central slit of the diaphragm is closed, the secondary fluid chamber is isolated from the outlet lumen, such that the translation of the plunger only draws fluid into or dispenses fluid out of the primary chamber via the outlet lumen; and Wherein, when the fluid pressure difference in the secondary fluid chamber and the plug inner cavity is increased enough to cause the wall of the dome-shaped diaphragm to buckle into its second state and open the central slit of the diaphragm, the skirt folds or pivots around the annular skirt hinge towards the second face of the diaphragm wall, and the secondary fluid chamber is in fluid communication with the outlet lumen, such that further translation of the plunger towards the distal end of the barrel distributes the fluid out of the secondary fluid chamber via the outlet lumen.

16. The syringe according to claim 15, wherein When the fluid pressure difference applied in the plug inner cavity is greater than about 30 pounds per square inch (2.07 bar), the dome-shaped diaphragm buckles from its first relaxed state to its second state.

17. The syringe according to claim 15, wherein a skirt of the floating plug further comprises a frustoconical skirt having a first axial face of a narrower diameter and a diverging second axial face, the first axial face being concentrically connected to a second face of the septum wall by an annular skirt hinge surrounding a central slit of the septum wall, the second axial face protruding from the skirt hinge and being oriented opposite to a distal end of the barrel such that buckling of the septum wall to its second state folds or pivots the skirt around the annular skirt hinge towards the second face of the septum wall.

18. The syringe according to claim 17, further comprising a recess defined by a second face of the septum wall, the recess being adapted to receive a folded or pivoted skirt when the septum wall is flexed to its second state.

19. The syringe according to claim 18, wherein, When the diaphragm wall is in its first state, the skirt prevents contact between the central slit and the distal end of the barrel.

20. The syringe according to claim 18, further comprising a protrusion formed at a distal end of the barrel and projecting inwardly towards the dome-shaped septum of the floating plug, the protrusion being coaxial with the axis of the barrel and being received within the central slit when the septum wall is in its second state.

21. The syringe according to claim 20, wherein the protrusion further comprises a blunt-ended tube in fluid communication with the outlet lumen of the connector.

22. The syringe according to claim 15, further comprising a recess defined by a second face of the septum wall, the recess being adapted to receive a folded or pivoted skirt when the septum wall is flexed to its second state.

23. The syringe according to claim 15, wherein, When the diaphragm wall is in its first state, the skirt prevents contact between the central slit and the distal end of the barrel.

24. The syringe according to claim 15, further comprising a protrusion formed at a distal end of the barrel and projecting inwardly towards the dome-shaped septum of the floating plug, the protrusion being coaxial with the axis of the barrel and being received within the central slit when the septum wall is in its second state.

25. The syringe according to claim 24, wherein the protrusion further comprises a blunt-ended tube in fluid communication with the outlet lumen of the connector.

26. The syringe according to claim 24, further comprising a through-orifice defined by a circumferential surface of the tube for establishing fluid communication between the interior of the tube and the outlet lumen of the connector.

27. The syringe according to claim 15, further comprising a second face of the septum wall defining a vertex of the dome-shaped septum.

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