Syringe

Abstract

The utility model relates to a syringe. A dual chamber syringe facilitates selective drug mixing, dosing and administration, and pre-or post-administration irrigation by 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 meridian 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 meridian dimension in a second state. Buckling of the diaphragm wall is caused only by the fluid differential pressure applied by a single plunger, and the diaphragm is not in physical contact with any other structure within the syringe.

Description

Technical Field

[0001] The present disclosure generally relates to dual chamber syringe assemblies 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 methods of flushing catheters. Background Art

[0002] VADs are commonly used therapeutic devices and include intravenous catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. VADs can become clogged if not properly maintained. To ensure that VADs are used correctly and do not become clogged, standards of practice have been developed. These standards include cleaning procedures, which are often referred to as flushing procedures or flushing the catheter.

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

[0004] For flushing procedures, an IV line refers to a system that includes a VAD, a tube set with a clamp, and can terminate with a port or a valve. The most common type of port is covered by a pierceable septum or a pre-slit septum, and is known in the art and is sometimes referred to as "PRN" from Latin pro re nata, meaning "when needed". The septum is preferably made of rubber or another elastomeric material that allows the insertion of a sharp needle cannula to infuse fluid or to withdraw fluid from a catheter. After the needle cannula is withdrawn, the septum seals itself. The port with a pre-slit septum is used with the truncated conical tip of a blunt cannula or a syringe barrel. The syringe tip or blunt cannula (which is usually attached to a syringe) is gently pushed through the pre-slit septum to establish fluid communication.

[0005] An IV valve (another type of terminal IV access device that does not require a needle with a sharp tip) is activated by the frustoconical tip of the syringe barrel to allow fluid communication between the interior of the syringe and the catheter. These valves may contain structure for delivering fluid from a reservoir in the valve to the catheter and are referred to in the art as positive displacement valves.

[0006] The removal of debris or residue is called "cleaning" or "flushing" and prevents blood deposits, blood residues, and intravenous medications from accumulating within the catheter or other VAD device. Such accumulation may result in partial or complete blockage of the fluid pathway in the catheter system and may also require expensive and potentially dangerous procedures for cleaning the affected catheter or full catheter exchange. Often, such blockages result in interruptions in treatment that may affect patient care. The accumulation of residue within the catheter may also increase the risk of infection by providing a medium for microorganisms to reproduce.

[0007] As will be appreciated by those skilled in the art, flushing techniques involve injecting a flushing solution (e.g., saline solution) into the VAD to clear debris and obstruction. Injection is usually accomplished by advancing a plunger rod into a pre-filled syringe barrel to discharge the flushing solution into the VAD. When such techniques are used in conjunction with a catheter, turbulence is introduced into the catheter to move any debris or residue attached to the catheter. Flushing techniques require applying substantially constant pressure or force to the plunger rod in a distal direction. Conventional or smooth flushing techniques may also include applying substantially linearly increasing or decreasing pressure or force to the plunger rod in a distal direction.

[0008] After flushing, the practitioner can then administer a dose of medical fluid, either in a bottle that needs to be drawn from, or in a separate pre-filled syringe. However, connecting multiple devices to the VAD introduces the connector to a non-sterile external environment, thereby introducing the possibility of a delivery catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. In order to reduce CRBSI instances and ensure proper use and maintenance of the VAD, standards of practice have been developed that include disinfection and cleaning procedures.

[0009] Administration of an IV medication followed by an IV flush is typically performed using two separate syringes in clinical practice.

[0010] There is a need for a syringe assembly having a means to both flush a VAD and administer a dose of a medical fluid, thereby reducing the risk of CRBSI. There is also a need for a syringe for administering an IV medication followed by an IV flush to increase clinician efficiency and reduce costs associated with maintaining syringe inventory and medical waste disposal. Utility Model Content

[0011] The dual chamber syringe facilitates selective drug mixing, dosing and administration through a catheter or other vascular access device (VAD), and flushing before or after administration of a catheter by a single syringe apparatus. The barrel of the syringe comprises an outlet and a variable volume main fluid chamber and an auxiliary fluid chamber separated by a floating stopper. The plunger can selectively translate within the barrel interior. The floating stopper is defined by a dome-shaped slit diaphragm with a central slit at its apex. The slit diaphragm is a bistable valve that closes the central slit by compression in its meridian dimension when the diaphragm is in a first relaxed state, and opens the central slit when the diaphragm is flexed (i.e., turned over) under tension in the meridian dimension in a second state. The flexion or turnover of the diaphragm wall is caused only by the fluid differential pressure applied by the plunger, and the diaphragm has no physical contact with any other structure in the syringe. The isolated auxiliary chamber structure advantageously facilitates the use of prepackaged drugs or flushing solutions in the chamber. In medical procedures requiring flushing and administration of medications through a catheter or other VAD, use of a syringe of the type disclosed herein reduces the need to perform multiple infusions and withdrawals of multiple single-function syringes. Use of the disclosed syringes advantageously reduces the risk of infection to the patient, reduces costs associated with syringe inventory and subsequent waste disposal, and reduces clinician time required to complete associated medical procedures.

[0012] One aspect of the present disclosure relates to a syringe comprising a substantially cylindrical barrel defining a first inner sidewall. The barrel has an open proximal end and a distal end, wherein the distal end of the barrel includes a connector defining an outlet lumen passing 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 sidewall of the barrel. The syringe comprises a plunger having a proximal end and a distal end, wherein its distal end is disposed within the barrel interior. The plunger is selectively translatable along its axis within the barrel interior. 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. An integral unistructural floating stopper is oriented within the barrel interior and is translatable between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall defining a stopper internal cavity that is openly communicated with its first axial end. The second axial end of the drum-shaped sidewall is connected to the peripheral base of the dome-shaped diaphragm defining the apex. The wall forming the diaphragm has a first face in communication with the plug internal cavity and a second face. The diaphragm wall further defines a central slit piercing both its first face and the second face at the apex. The diaphragm wall of the dome-shaped diaphragm forms a bistable valve that closes the central slit by compression in its meridian dimension when the diaphragm is in a first relaxed state, and opens the central slit when the diaphragm flexes under tension in the meridian dimension in a second state. The open central slit allows pressurized fluid to flow from the internal plug cavity to the outside of the second face of the diaphragm, wherein the flexion of the diaphragm wall is caused only by a higher differential pressure of the fluid in the plug internal cavity on the first face than on the second face, and the diaphragm wall has no physical contact with any other structure in the syringe. A main fluid chamber within the barrel interior is defined between the diaphragm and the outlet lumen of the floating plug. The main fluid chamber is in fluid communication with the central slit of the diaphragm; the volume of the main fluid chamber can be selectively changed by translation of the plunger. The syringe has an auxiliary fluid chamber, which is defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper. The auxiliary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume and fluid pressure within the auxiliary fluid chamber can be selectively varied by translation of the plunger. When the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger only draws fluid into the main chamber or dispenses fluid out of the main chamber via the outlet lumen. When the central slit of the diaphragm is opened by increasing the differential pressure of the fluid in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to flex the wall of the dome-shaped diaphragm into its second state, the auxiliary fluid chamber is in fluid communication with the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses fluid out of the auxiliary chamber via the outlet lumen.

[0013] In some embodiments of the syringe disclosed herein, its auxiliary chamber is pre-filled with a flushing solution. Desirably, in those embodiments, a clinician can administer medication to a patient's VAD through the primary chamber and immediately flush the VAD through the secondary chamber by a single continuous advancement of the plunger, 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, which includes a substantially cylindrical barrel, the barrel defining a first inner sidewall, wherein the barrel has an open proximal end and a distal end. The distal end of the barrel includes a connector defining an outlet lumen passing therethrough, wherein the outlet lumen is in fluid communication with the interior of the barrel. The barrel interior is defined by the open proximal end, the distal end, and the first inner sidewall of the barrel. The syringe includes a plunger having a proximal end and a distal end; its distal end is disposed within the barrel interior. The plunger is selectively translatable along its axis within the barrel interior. 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 barrel interior and is translatable between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall defining a stopper internal cavity that is openly communicated with its first axial end. The second axial end of the drum sidewall is connected to the peripheral base of the dome-shaped diaphragm defining the apex by an intermediate annular flexible hinge. The wall forming the diaphragm has a first face communicating with the internal cavity of the stopper and a second face. The diaphragm wall defines a central slit piercing both its first face and its second face at the apex. The diaphragm wall of the dome-shaped diaphragm forms a bistable valve, closing the central slit by compression in its warp dimension when the diaphragm is in a first relaxed state, in which the apex is closer to the first axial end of the drum sidewall, and opening the central slit when the diaphragm flexes under tension in the warp dimension in a second state, in which the apex is farther away from the first axial end of the drum sidewall. The open central slit allows pressurized fluid to flow from the internal stopper cavity to the outside of the second face of the diaphragm, wherein the flexion of the diaphragm wall is caused only by a higher differential pressure of the fluid in the internal cavity of the stopper on the first face than on the second face, and the diaphragm wall has no physical contact with any other structure in the syringe. The main fluid chamber within the barrel interior is defined between the diaphragm and the outlet lumen of the floating stopper. The main fluid chamber is in fluid communication with the central slit of the diaphragm, and the volume of the main fluid chamber can be selectively changed by the translation of the plunger. An auxiliary fluid chamber within the barrel is defined between the distal end surface of the plunger plug and the diaphragm of the floating plug, and the auxiliary fluid chamber is in fluid communication with the central slit of the diaphragm. The volume and fluid pressure in the auxiliary fluid chamber can be selectively changed by the translation of the plunger. When the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that the translation of the plunger only draws the fluid into the main chamber or distributes the fluid out of the main chamber via the outlet lumen. When the central slit of the diaphragm is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the plug enough to bend the wall of the dome-shaped diaphragm into its second state, the auxiliary fluid chamber is in fluid communication with the outlet lumen, so that further translation of the plunger toward the distal end of the barrel distributes the fluid out of the auxiliary chamber via the outlet lumen.

[0015] Another aspect of the present disclosure relates to a syringe, which includes a substantially cylindrical barrel that defines a first inner sidewall. The barrel has an open proximal end and a distal end, wherein the distal end of the barrel includes a connector defining an outlet lumen passing 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 sidewall of the barrel. The syringe includes a plunger having a proximal end and a distal end, wherein its distal end is disposed within the barrel interior. The plunger is selectively translatable along its barrel axis within the barrel interior. A plunger stopper is coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel. An integral single structure floating stopper is oriented within the barrel interior and is translatable between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall that defines an internal stopper cavity that is openly communicated with its first axial end. The second axial end of the drum-shaped sidewall is connected to the peripheral base of a dome-shaped diaphragm defining an apex. The wall forming the diaphragm has a first face communicating with the internal cavity of the stopper and a second face in an opposite orientation to the distal end of the barrel. The diaphragm wall defines a central slit piercing both of its first and second faces at an apex. The floating stopper further defines a skirt having a first axial face concentrically connected to the second face of the diaphragm wall by an annular skirt hinge around the central slit, and a second axial face extending from the skirt hinge in an opposite orientation 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 warp dimension when the diaphragm is in a first relaxed state, in which the apex is closer to the first axial end of the drum-shaped sidewall, and opens the central slit when the diaphragm flexes under tension in the warp dimension in a second state, in which the apex is farther from the first axial end of the drum-shaped sidewall. The open central slit allows pressurized fluid to flow from the internal stopper cavity to the outside of the second face of the diaphragm, wherein the flexure of the diaphragm wall is caused only by a higher differential pressure of the fluid in the internal cavity of the stopper on the first face than on the second face thereof, and the diaphragm wall is not in physical contact with any other structure in the syringe. A primary fluid chamber within the barrel interior 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, and the volume of the primary fluid chamber can be selectively varied by translation of the plunger. An auxiliary fluid chamber within the barrel interior is defined between the distal end surface of the plunger stopper and the diaphragm of the floating stopper. The auxiliary fluid chamber is in fluid communication with the central slit of the diaphragm; the volume and fluid pressure within the auxiliary fluid chamber can be selectively varied by translation of the plunger. When the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger only draws fluid into the primary chamber or dispenses fluid out of the primary chamber via the outlet lumen.When the central slit of the septum is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to flex the wall of the dome-shaped septum into its second state, the skirt folds or pivots about the annular skirt hinge toward the second face of the septum wall, and the auxiliary fluid chamber is in fluid communication with the outlet lumen. Further translation of the plunger toward the distal end of the barrel dispenses the fluid out of the auxiliary chamber via the outlet lumen.

[0016] The various aspects of the present disclosure and the respective features of the exemplary embodiments described herein may be applied jointly or individually in any combination or sub-combination.

[0017] In some embodiments, the syringe of the present application comprises:

[0018] a substantially cylindrical barrel defining a first inner sidewall, 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 an interior of the barrel defined by the open proximal end of the barrel, the distal end, and the first inner sidewall;

[0019] a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the barrel interior and selectively translatable along its axis within the barrel interior;

[0020] a plunger stopper coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel;

[0021] An integral unitary structure floating stopper oriented within the barrel interior and capable of translating between the plunger stopper and the distal end of the barrel, the floating stopper having a drum-shaped sidewall defining an internal stopper cavity in open communication with a first axial end thereof, a second axial end of the drum-shaped sidewall being joined to a peripheral base of a dome-shaped diaphragm defining an apex, the wall forming the diaphragm having a first face in communication with the internal stopper cavity and a second face, the diaphragm wall further defining a central slit piercing both the first face and the second face thereof at the apex, the dome wherein the diaphragm wall of the diaphragm forms a bistable valve, the bistable valve closing the central slit by compression in the meridional dimension thereof when the diaphragm is in a first relaxed state, and opening the central slit when the diaphragm flexes under tension in the meridional dimension in a second state, the open central slit allowing pressurized fluid to flow from the internal stopper cavity out of the second face of the diaphragm, wherein the flexure of the diaphragm wall is caused solely by a higher differential pressure of the fluid in the stopper internal cavity on the first face than on the second face thereof, the diaphragm wall having no physical contact with any other structure within the syringe;

[0022] a primary fluid chamber defined within the barrel interior between the diaphragm and the outlet lumen of the floating plug, 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

[0023] an auxiliary fluid chamber defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper, the auxiliary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the auxiliary fluid chamber being selectively variable by translation of the plunger;

[0024] wherein, when the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger draws fluid into or dispenses fluid out of the main chamber only via the outlet lumen; and

[0025] wherein, when the central slit of the diaphragm is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to cause the wall of the dome-shaped diaphragm to flex into its second state, the auxiliary fluid chamber is fluidically connected to the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses the fluid out of the auxiliary chamber via the outlet lumen.

[0026] In some embodiments, the syringe of the present application includes that the first face of the septum wall defines recesses that diverge outwardly from the central slit toward the first axial end of the floating stopper.

[0027] In some embodiments, the dome-shaped diaphragm flexes from its first, relaxed state to its second state when a fluid differential pressure greater than about 30 pounds per square inch (2.07 bar) is applied within the plug interior cavity.

[0028] In some embodiments, the floating plug further comprises a skirt having a first axial face concentrically connected to the second face of the diaphragm wall by an annular skirt hinge surrounding the central slit of the diaphragm wall, and a second axial face extending from the skirt hinge in an orientation relative to the distal end of the barrel, whereby flexure of the diaphragm wall to its second state causes the skirt to fold or pivot about the annular skirt hinge toward the second face of the diaphragm wall.

[0029] In some embodiments, the syringe of the present application also includes a protrusion formed at the distal end of the barrel, which protrudes inwardly toward the dome-shaped septum of the floating stopper, is coaxial with the barrel axis, and is received in the central slit when the septum wall is in its second state.

[0030] In some embodiments, the protrusion further comprises a blunt-tipped tube in fluid communication with the outlet lumen of the connector.

[0031] In some embodiments, the syringe of the present application also includes a protrusion formed at the distal end of the barrel, which protrudes inwardly toward the dome-shaped septum of the floating stopper, is coaxial with the barrel axis, and is received in the central slit when the septum wall is in its second state.

[0032] In some embodiments, the syringe of the present application further comprises: the first surface of the septum wall defines the apex of the dome-shaped septum.

[0033] In some embodiments, the syringe of the present application further comprises: the second surface of the septum wall defines the apex of the dome-shaped septum.

[0034] In some embodiments, the syringe of the present application comprises:

[0035] a substantially cylindrical barrel defining a first inner sidewall, 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 an interior of the barrel defined by the open proximal end of the barrel, the distal end, and the first inner sidewall;

[0036] a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the barrel interior and selectively translatable along its axis within the barrel interior;

[0037] a plunger stopper coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel;

[0038] an integral unitary structure floating stopper oriented within the barrel interior and capable of translating between the plunger stopper and the distal end of the barrel, the floating stopper having a drum-shaped sidewall defining an internal stopper cavity in open communication with a first axial end thereof, a second axial end of the drum-shaped sidewall being joined by an intermediate annular flexible hinge to a peripheral base of a dome-shaped diaphragm defining an apex, the wall forming the diaphragm having a first face in communication with the internal stopper cavity and a second face, the diaphragm wall defining a central slit piercing both the first face and the second face thereof at the apex;

[0039] said diaphragm wall of said dome-shaped diaphragm forming a bistable valve, said bistable valve closing said central slit by compression in its meridional dimension when said diaphragm is in a first relaxed state in which said apex is closer to said first axial end of said drum-shaped sidewall, and opening said central slit when said diaphragm flexes under tension in said meridional dimension in a second state in which said apex is further away from said first axial end of said drum-shaped sidewall, the open central slit permitting pressurized fluid to flow from said internal stopper cavity out of said second face of said diaphragm, wherein flexion of said diaphragm wall is caused solely by a higher differential pressure of fluid in said stopper internal cavity on said first face than on its second face, said diaphragm wall having no physical contact with any other structure within said syringe;

[0040] a primary fluid chamber defined within the barrel interior between the diaphragm and the outlet lumen of the floating plug, 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

[0041] an auxiliary fluid chamber defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper, the auxiliary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the auxiliary fluid chamber being selectively variable by translation of the plunger;

[0042] wherein, when the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger draws fluid into or dispenses fluid out of the main chamber only via the outlet lumen; and

[0043] wherein, when the central slit of the diaphragm is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to cause the wall of the dome-shaped diaphragm to flex into its second state, the auxiliary fluid chamber is fluidically connected to the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses the fluid out of the auxiliary chamber via the outlet lumen.

[0044] In some embodiments, the syringe of the present application further comprises: the first face of the septum wall defines a notch diverging outwardly from the central slit toward the first axial end of the floating stopper.

[0045] In some embodiments, the dome-shaped diaphragm flexes from its first, relaxed state to its second state when a fluid differential pressure greater than about 30 pounds per square inch (2.07 bar) is applied within the plug interior cavity.

[0046] In some embodiments, the syringe of the present application further comprises that the thickness of the septum wall increases from the base to the apex of the dome-shaped septum.

[0047] In some embodiments, the syringe of the present application further comprises: the first surface of the septum wall defines the apex of the dome-shaped septum.

[0048] In some embodiments, the syringe of the present application comprises:

[0049] a substantially cylindrical barrel defining a first inner sidewall, 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 an interior of the barrel defined by the open proximal end of the barrel, the distal end, and the first inner sidewall;

[0050] a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the barrel interior and selectively translatable within the barrel interior along a barrel axis thereof;

[0051] a plunger stopper coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel;

[0052] An integral unitary floating stopper oriented within the barrel interior and capable of translating between the plunger stopper and the distal end of the barrel, the floating stopper having a drum-shaped sidewall defining an internal stopper cavity in open communication with a first axial end thereof, a second axial end of the drum-shaped sidewall being joined to a peripheral base of a dome-shaped diaphragm defining an apex, a wall forming the diaphragm having a first face in communication with the internal stopper cavity and a second face oriented oppositely to the distal end of the barrel, the diaphragm wall defining a central slit piercing both the first face and the second face thereof at the apex, the floating stopper further defining a skirt having a first axial face concentrically connected to the second face of the diaphragm wall by an annular skirt hinge surrounding the central slit of the diaphragm wall, and a peripheral base oriented at the distal end of the barrel. said diaphragm wall of said dome-shaped diaphragm forming a bistable valve at an oppositely oriented second axial face extending from said skirt hinge, said diaphragm wall of said dome-shaped diaphragm closing said central slit by compression in its warp dimension when said diaphragm is in a first relaxed state wherein said apex is closer to said first axial end of said drum-shaped sidewall, and opening said central slit when said diaphragm flexes under tension in said warp dimension in a second state wherein said apex is further away from said first axial end of said drum-shaped sidewall, the open central slit permitting pressurized fluid to flow from said internal stopper cavity out of said second face of said diaphragm, wherein flexing of said diaphragm wall is caused solely by a higher differential pressure of fluid in said stopper internal cavity on said first face than on its second face, said diaphragm wall having no physical contact with any other structure within said syringe;

[0053] a primary fluid chamber defined within the barrel interior between the diaphragm and the outlet lumen of the floating plug, 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

[0054] an auxiliary fluid chamber defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper, the auxiliary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the auxiliary fluid chamber being selectively variable by translation of the plunger;

[0055] wherein, when the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger draws fluid into or dispenses fluid out of the main chamber only via the outlet lumen; and

[0056] wherein, when the central slit of the diaphragm is opened by increasing the differential pressure of the fluid in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to flex the wall of the dome-shaped diaphragm into its second state, the skirt folds or pivots about the annular skirt hinge toward the second face of the diaphragm wall, and the auxiliary fluid chamber is in fluid communication with the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses the fluid out of the auxiliary chamber via the outlet lumen.

[0057] In some embodiments, the dome-shaped diaphragm flexes from its first, relaxed state to its second state when a fluid differential pressure greater than about 30 pounds per square inch (2.07 bar) is applied within the plug interior cavity.

[0058] In some embodiments, the skirt of the floating plug also includes a frustoconical skirt having a first axial face of narrower diameter concentrically connected to the second face of the diaphragm wall by the annular skirt hinge surrounding the central slit of the diaphragm wall, and a diverging second axial face extending from the skirt hinge in a relative orientation to the distal end of the barrel, whereby flexure of the diaphragm wall to its second state causes the skirt to fold or pivot about the annular skirt hinge toward the second face of the diaphragm wall.

[0059] In some embodiments, the syringe of the present application further comprises: the second face of the septum wall defines a recessed portion, the recessed portion being configured to receive the folded or pivoted skirt when the septum wall is flexed to its second state.

[0060] In some embodiments, wherein the skirt blocks contact between the central slit and the distal end of the barrel when the septum wall is in its first state.

[0061] In some embodiments, the syringe of the present application also includes a protrusion formed at the distal end of the barrel, which protrudes inwardly toward the dome-shaped septum of the floating stopper, is coaxial with the barrel axis, and is received in the central slit when the septum wall is in its second state.

[0062] In some embodiments, the protrusion further comprises a blunt-tipped tube in fluid communication with the outlet lumen of the connector.

[0063] In some embodiments, the syringe of the present application further comprises: the second face of the septum wall defines a recessed portion, the recessed portion being configured to receive the folded or pivoted skirt when the septum wall is flexed to its second state.

[0064] In some embodiments, wherein the skirt blocks contact between the central slit and the distal end of the barrel when the septum wall is in its first state.

[0065] In some embodiments, the syringe of the present application also includes a protrusion formed at the distal end of the barrel, which protrudes inwardly toward the dome-shaped septum of the floating stopper, is coaxial with the barrel axis, and is received in the central slit when the septum wall is in its second state.

[0066] In some embodiments, the protrusion further comprises a blunt-tipped tube in fluid communication with the outlet lumen of the connector.

[0067] In some embodiments, the syringe of the present application further comprises: a peripheral surface of the tube defines a through hole, and the through hole is used to establish fluid communication between the interior of the tube and the outlet lumen of the connector.

[0068] In some embodiments, the syringe of the present application further comprises: the second surface of the septum wall defines the apex of the dome-shaped septum. BRIEF DESCRIPTION OF THE DRAWINGS

[0069] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0070] Figure 1 is a cross-sectional view of an embodiment of a dual chamber syringe, wherein each of a primary chamber and an auxiliary chamber contains a fluid, isolated from each other by a floating stopper;

[0071] Figure 2 yes Figure 1 Detailed cross-sectional view of a syringe of , showing dispensing of fluid from a primary chamber with a floating stopper isolating fluid in an auxiliary chamber;

[0072] Figure 3 yes Figure 1 Detailed cross-sectional view of a syringe dispensing fluid from an auxiliary chamber via a floating stopper;

[0073] Figure 4 is a cross-sectional view of another embodiment of a dual chamber syringe, wherein an auxiliary chamber thereof contains a fluid;

[0074] Figure 5 yes Figure 4 An enlarged partial cross-sectional view of a syringe;

[0075] Figure 6 After dispensing fluid from the auxiliary chamber Figure 4 an enlarged partial cross-sectional view of a syringe of; and

[0076] Figures 7 to 10 are illustrative sequential steps showing, respectively, aspiration and dispensing / infusion of a fluid (such as a drug) in a primary chamber, followed by dispensing of the fluid from the auxiliary chamber.

[0077] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures. The figures are not drawn to scale. DETAILED DESCRIPTION

[0078] Aspects of the dual-chamber syringe embodiments disclosed herein facilitate selective drug mixing, dosing and administration through a catheter or other vascular access device (VAD), as well as pre- or post-administration flushing of the catheter through a single syringe apparatus. In general, in each disclosed embodiment, the syringe includes a substantially cylindrical barrel that defines a first inner sidewall. 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, defining an outlet lumen passing 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 sidewall. The plunger has a distal end, wherein the plunger stopper is disposed within the interior of the barrel; the plunger can selectively translate within the interior of the barrel. An integral single structure floating stopper is oriented within the barrel interior and can translate between the plunger stopper and the distal end of the barrel. The floating stopper has a drum-shaped sidewall that defines an internal cavity of the stopper that is openly communicated with its first axial end. The second axial end of the drum-shaped sidewall is connected to the peripheral base of the dome-shaped diaphragm defining the apex. The wall forming the diaphragm has a first face and a second face that are communicated with the internal cavity of the stopper. The diaphragm wall further defines a central slit that pierces both its first face and the second face at the apex. The diaphragm wall forms a bistable valve that closes the central slit by compression in its meridian dimension when the diaphragm is in a first relaxed state, and opens the central slit when the diaphragm is flexed (i.e., flipped) under tension in the meridian dimension in the second state. When the central slit is open, it allows pressurized fluid to flow from the internal stopper cavity to the outside of the second face of the diaphragm. The flexion of the diaphragm wall is caused only by a higher fluid differential pressure on the first face than on the second face in the internal cavity of the stopper, and the diaphragm wall has no physical contact with any other structure in the syringe. The differential pressure is generated by translating the plunger toward the distal end of the barrel.

[0079] The floating plug separates the interior of the barrel into a primary fluid chamber defined between itself and the distal end of the barrel; and an auxiliary fluid chamber defined between itself and the plunger plug. When the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger only draws fluid into or dispenses fluid out of the primary chamber via the outlet lumen. When the central slit of the diaphragm is opened by increasing the differential pressure of the fluid in the auxiliary fluid chamber and in the internal cavity of the plug sufficient to flex or flip the wall of the dome-shaped diaphragm into its second state, the auxiliary fluid chamber is in fluid communication with the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses fluid out of the auxiliary chamber via the outlet lumen.

[0080] The isolated auxiliary chamber configuration advantageously facilitates the use of prepackaged medication or flushing solutions in the chamber, whereby in a single plunger stroke, the clinician can aspirate and dispense medication with the empty main chamber and then immediately deliver the prepackaged flushing solution from the auxiliary chamber without having to manipulate additional plungers, manual valves, or locks. In other embodiments, the syringe disclosed herein is used as a drug mixing syringe that is prepackaged with a powdered medication in the main chamber and a diluent solution in the auxiliary chamber. In some embodiments, a single advancement stroke on a single plunger of the syringe automatically delivers or infuses the medication contained in the main chamber followed by the flushing solution sequentially into the VAD.

[0081] In this disclosure, a convention is followed where the distal end of a device is the end 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 away from the patient and closest to a clinician or other medical practitioner. For terms used in this disclosure, the following definitions are provided.

[0082] As used herein, the use of “a”, “an” and “the” includes both the singular and the plural.

[0083] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way of attaching syringes, catheters, needles with hubs, IV tubing, etc. to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered so that they can be held together better with even a simple press / twist fit. Luer connectors can optionally include an additional threaded outer rim, allowing them to be more secure. The male end of the Luer connector is associated with a flush syringe and can interlock and connect with 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.

[0084] As used herein, ISO 80369-7:2016 defines the specifications of 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 ISO 80369-7:2016, the male standard Luer connector has an outer cross-sectional diameter between 3.970mm and 4.072mm measured at 0.75mm from the distal end of the tip. The length of the male standard Luer taper is between 7.500mm and 10.500mm. The outer cross-sectional diameter measured at 7.500mm from the distal end of the tip is between 4.376mm and 4.476mm. As used herein, the phrases "male standard Luer connector" and "female standard Luer connector" shall refer to connectors with the dimensions described in ISO 80369-7, the entire contents of which are incorporated herein by reference.

[0085] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "tip", "needle seat", "thread", "protrusion / insert", "tab", "bevel", "wall", "top", "side", "bottom", etc. are used throughout the specification to facilitate understanding, they are not intended to limit any components that can be combined or used separately or require a specific spatial orientation to implement the various aspects of the embodiments of the present disclosure.

[0086] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or processing steps set forth in the following description. The present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0087] The content illustrated in this description is provided to help fully understand the exemplary embodiments of the present disclosure. Therefore, 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. In addition, for the sake of clarity and simplicity, descriptions of well-known functions and structures are omitted.

[0088] In an exemplary embodiment of the present disclosure, the barrel of the syringe includes a distal end having a needleless connector. In one or more embodiments, the needleless connector includes at least one thread and other features in all combinations, thereby allowing it to engage with one or more corresponding threads of a corresponding connector.

[0089] According to another exemplary embodiment of the present disclosure, the configuration of the structural elements constituting the needleless connector includes a collar extending from the distal end of the barrel, the collar including at least one thread to connect to one or more corresponding threads of the corresponding connector. According to another exemplary embodiment of the present disclosure, the syringe includes a needle-type connector for aspirating a drug from a bottle, rather than a needleless connector.

[0090] According to further additional exemplary implementations of embodiments of the present disclosure, the collar or needleless connector may bend or elastically deform to allow for better interference fit compliance with a corresponding connector.

[0091] According to further additional exemplary embodiments of embodiments of the present disclosure, the needleless connector may include female threads sized and having a thread pattern to engage with a standard ISO594-2 type male connector, and / or male threads sized and having a thread pattern to engage with a standard ISO594-2 type female connector. An example of an ISO594-2 type connector is a Q-type connector. According to further additional exemplary embodiments of embodiments of the present disclosure, the needleless connector may be used with a needle-type connector for inhaling medication from a bottle.

[0092] In one or more embodiments, the female connector can be selected from the group consisting essentially of a needle connector (for direct injection into a patient or insertion into a vial to inhale a dose of medication 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-type 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 IV line end or a stopcock.

[0093] Referring now to the accompanying drawings, Figures 1 to 3, wherein a syringe 20 comprises a substantially cylindrical barrel 22 defining an open proximal end 24 and a distal end 26. The distal end 26 of the barrel 22 comprises a Luer connector 28 defining 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 delimited 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. A plunger 34 is selectively translatable within the barrel interior. The plunger 34 has a distal end 36 with a male thread 38 for coupling to a plunger stopper 40 by mating with a female thread 42 formed in the stopper. The mating male thread 38 and the female thread 42 together constitute a connection feature to removably or non-removably couple the plunger 34 and the plunger stopper 40. Alternatively, in one or more embodiments, the connection feature couples the plunger 34 and the plunger stopper 40 by an interference fit. In one or more embodiments, the connection feature couples the plunger 34 and the plunger stopper 40 by a snap fit. In one or more embodiments, the connection feature couples the plunger 34 and the plunger stopper 40 by a twist lock fit. In one or more embodiments, the connection feature couples the plunger 34 and the plunger stopper 40 by sonic welding or a medical grade adhesive. In one or more embodiments, the plunger stopper 40 is integrally formed with the distal end 36 of the plunger 34. The plunger stopper 40 includes radially oriented ribs 43 and a distal end 44 facing 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 truncated conical shape.

[0094] An integral, unitary structure floating stopper 46 is oriented within the barrel interior and is capable of translating 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 having 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 in open communication with its first axial end 50. The second axial end 52 of the drum-shaped sidewall 48 is connected to the peripheral base of a dome-shaped diaphragm 58 by an intermediate annular flexible hinge 56. The wall 59 forming the diaphragm 58 has a first face 60 forming the apex 61 of the dome and is in communication with the internal cavity 54. The wall 59 forming the diaphragm has a second face 62 opposite its first face 60. In Figures 1 to 3In some embodiments, 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 the third and fourth separable faces 66, 68 of its wall 59 that are oriented along the meridian. The central slit 64 pierces both its first face 60 and second face 62 at the apex 61. The first face 60 of the diaphragm wall 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 includes a molded elastomeric material, such as isoprene rubber.

[0095] The floating stopper 46 separates the interior of the syringe barrel 22 into a primary fluid chamber 72 defined between itself and the distal end 26 of the barrel; and an auxiliary fluid chamber 74 defined between itself and the plunger stopper 40. Translation of the plunger 34 generates a differential pressure P across the floating stopper 46, wherein withdrawing the plunger translates the floating stopper toward the proximal end 24 of the syringe barrel 22. Conversely, advancing the plunger 34 translates the floating stopper 46 toward the distal end 26 of the syringe barrel 22. When the central slit 64 of the dome-shaped septum 58 is closed, the auxiliary fluid chamber 74 is isolated from the outlet lumen 30, so that translation of the plunger 34 draws fluid into or dispenses fluid out of the primary chamber 72 only via the outlet lumen 30.

[0096] 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 is closed by its meridian dimension ( Figure 2 The dome-shaped diaphragm 58 is compressed on the dashed line C of the embodiment of the present invention to close the central slit 64, with its apex 61 being closer to the first axial end 50 of the drum-shaped sidewall 48 in the first default relaxed state. The dome-shaped diaphragm 58 remains in its relaxed closed state unless and until it is flexed and extended (i.e., flipped, as shown in the second state) under tension in its warp dimension. Figure 3 4 (shown as dashed line E in FIG. 4 ), in the second state 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 flexed state, its central slit 64 is open, thereby allowing fluid to flow out of the auxiliary chamber 74, through the internal stopper cavity 54, and out of its second face 62. Thereafter, the fluid flows through the primary chamber 72 so that it is dispensed or discharged through the outlet lumen 30.

[0097] Flexion or inversion of the wall 59 of the dome-shaped diaphragm 58 is caused only by applying a sufficiently high flexion fluid differential pressure 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 differential pressure level P on the first face 60 of the dome-shaped diaphragm 58 within the internal cavity 54 of the floating plug 46, the BWhen the diaphragm wall 59 is bent to its second state (such as Figure 3 As shown in FIG. 1 , the septum wall has no physical contact with any other structure in the syringe 20. When the differential pressure P on the first surface 60 drops below the buckling differential pressure P B , the dome-shaped plug 58 relaxes to its first state, thereby closing the central slit 64, thereby reclosing the bistable valve and reisolating the auxiliary chamber 74 from the first chamber 72. In some embodiments, the buckling differential pressure P B Greater than about 30 pounds per square inch (2.07 bar).

[0098] In one or more embodiments of the syringe 20, the main chamber 72 is pre-filled or filled on-site with the desired medicament. In one or more embodiments, the auxiliary chamber 74 is pre-filled with a desired amount of saline flushing fluid. In one or more embodiments, the auxiliary chamber 74 is filled with a desired medicament. In one or more embodiments, the main chamber 72 and the auxiliary chamber 74 are both filled with the desired medicament. In one or more embodiments, the main chamber 72 and the auxiliary chamber 74 are both filled with a desired amount of saline flushing fluid. In one or more embodiments, the main chamber 72 and / or the auxiliary chamber 74 are pre-filled with fluid using a sterile filling method during or after the assembly of the syringe 20. 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 with the capped connector 28 is used to reconstitute the powdered medicament that has been pre-filled in the main chamber 72 by dispersing the pre-filled dilution liquid stored in the auxiliary chamber 74 into the main chamber before the connector is uncovered. In other applications, medication is drawn into and dispensed into the VAD via primary chamber 72 , and the VAD is subsequently flushed via a flushing solution stored in auxiliary chamber 74 .

[0099] exist Figures 4 to 10 Another aspect of the present disclosure is shown in , wherein a syringe 80 includes a substantially cylindrical barrel 82, which 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 defining 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 delimited 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 barrel interior. The plunger 94 has a distal end 95 connected to a plunger stopper 96 by a connector feature of the type previously described with respect to the embodiment of the syringe 20. The plunger stopper 90 includes a radially oriented rib 97 and a distal end 98 facing 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 truncated conical shape.

[0100] An integral, unitary structure floating stopper 100 is oriented within the barrel interior and is capable of translating 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 having radial ribs 103, a first axial end 104 facing the plunger stopper 96, an internal cavity 106 in open communication with the first axial end thereof, and a second axial end 108 facing the distal end 86 of the syringe barrel 82. The second axial end 108 of the drum-shaped sidewall 102 is joined to a peripheral base of a dome-shaped diaphragm 110 that defines an apex 112. A wall 113 forming the diaphragm 110 has a first face 114 in communication with the internal cavity 106 and a second face 116 opposite the first face 114 thereof, the second face defining the apex 112. The second face 116 is in an opposing orientation to the distal end 86 of the syringe barrel 82. Figures 4 to 6 In some 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 plug 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 of its wall 113 oriented along the warp, which define a central slit 122 in between. The central slit 122 is oriented along the warp and pierces both the first face 60 and the second face 62 of the dome-shaped diaphragm 110 at the apex 112.

[0101] The floating stopper 110 also includes a generally annular flexible skirt hinge 124 coupled to the second face 116 of the dome-shaped septum 110, which surrounds the central slit 122. A frustoconical skirt 126 has a first axial face 127 of smaller diameter coupled to the skirt hinge 124 and a second axial face 128 of larger diameter extending away from the skirt hinge in an opposing orientation to the distal end 86 of the syringe barrel 82. Figure 6 , the skirt 126 is capable of pivoting about the skirt hinge 124 and allowing it to fold toward the second side 116 of the dome-shaped diaphragm 110 into a recess 130 about the skirt hinge. In other embodiments, the skirt includes a profile other than a frustoconical profile. In other embodiments, the second side 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.

[0102] The floating stopper 100 separates the interior of the syringe barrel 82 into a primary fluid chamber 140 defined between itself and the distal end 86 of the barrel; and an auxiliary fluid chamber 142 defined between itself and the plunger stopper 96. Translation of the plunger 94 generates a differential pressure P across the floating stopper 100, wherein withdrawing the plunger translates the floating stopper toward the proximal end 84 of the syringe barrel 82. Conversely, advancing the plunger 94 translates the floating stopper 100 toward the distal end 86 of the syringe barrel 82. When the central slit 122 of the dome-shaped septum 110 is closed, the auxiliary fluid chamber 142 is isolated from the outlet lumen 90, so that translation of the plunger 94 draws fluid into or dispenses fluid out of the primary chamber 140 only via the outlet lumen 90.

[0103] The diaphragm wall 113 of the dome-shaped diaphragm 110 forms a bistable valve, which is conceptually similar to Figures 1 to 3 The dome-shaped diaphragm 58 of the syringe 20 is a bistable valve. Figures 4 to 10 In the embodiment of the present invention, the bistable valve closes the central slit 124 by compression of the dome-shaped diaphragm 110 in its meridian dimension when the diaphragm is in a first default relaxed state in which its apex 112 is closer to the first axial end 104 of the drum-shaped sidewall 102. The dome-shaped diaphragm 110 remains in its relaxed closed state unless ( Figure 5 ) and until it flexes and extends under tension in its warp dimension in a second state (i.e., flips, as Figure 6 102, wherein the dome-shaped diaphragm 110 is in its second flexed state, wherein the apex 112 thereof 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 flexed state, its central slit 122 is open, thereby allowing fluid to flow out of the auxiliary chamber 142, through the internal stopper cavity 106, and out of its second face 116. Thereafter, the fluid flows through the primary chamber 140 so that it is dispensed or discharged through the outlet lumen 90. The flexion and extension of the dome-shaped diaphragm 110 to its second state also facilitates the folding of the skirt 126 toward the second face 116 and the recessed portion 130.

[0104] Flexion or inversion of the wall 113 of the dome-shaped diaphragm 110 is caused only by applying a sufficiently high flexion fluid differential pressure P on the floating plug 100 by pressing and translating the plunger 94 toward the distal end 86 of the barrel 82. B When the plunger 94 is pressed with sufficient force to exceed the buckling fluid differential pressure level P on the first face 114 of the dome-shaped diaphragm 110 within the internal cavity 106 of the floating plug 100, B When the diaphragm wall 113 is bent to its second state (such as Figure 6 As shown in FIG. 1 , the septum wall has no physical contact with any other structure in the syringe 80. When the differential pressure P on the first surface 114 drops below the buckling differential pressure P B Unless Figure 6 As shown, the dome-shaped plug 110 is blocked by the barrel protrusion 132, otherwise the dome-shaped plug 110 relaxes to its first state, thereby closing the central slit 122, thereby reclosing the bistable valve and reisolating the auxiliary chamber 142 from the first chamber 140. In some embodiments, the buckling differential pressure P B Greater than about 30 pounds per square inch (2.07 bar).

[0105] Reference Figure 5 and Figure 6 , the distal end 86 of the syringe barrel 82 forms a generally tubular barrel protrusion 132 that projects inwardly toward the dome-shaped septum 110 of the floating stopper 100 and is coaxially aligned with the barrel axis 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 main chamber 140 and a fluid passage 136 within the barrel protrusion. The fluid passage 136 formed in the barrel protrusion 132 facilitates fluid communication between the main chamber 140 and the outlet lumen 90 through the one or more through-notches 134 around the perimeter of the sidewall 133 and axially through the blunt tip 138. In other embodiments, the tubular barrel protrusion 132 defines other profiles.

[0106] Figure 4 , Figure 5 and Figure 6 The interaction of the septum 110, skirt 126 and barrel projection 132 of a certain shape of syringe 80 is shown, wherein the auxiliary fluid chamber 142 contains fluid and the main fluid chamber 140 contains at most residual fluid between the floating stopper 100 and the distal end 86 of the syringe barrel 82. Figure 5 , the dome-shaped diaphragm 110 is in its first, relaxed state with the central slit 122 closed. The second axial face 128 of the skirt 126 extends axially toward and abuts the distal end 86 of the syringe barrel 82. In this position, the skirt 126 prevents the barrel protrusion 132 from entering the central slit 132 of the diaphragm 110. Any fluid in the primary fluid chamber 140 is in communication with the through-recess 134 and can flow through the fluid passage 136 of the barrel protrusion 132 and out of the outlet lumen 90 of the syringe 80. In contrast, any fluid in the auxiliary 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 the central slit 122 closed, the pressure in the auxiliary fluid chamber 142 is below the flexion pressure required to flex or flip the diaphragm to its second state. Referring to FIG. Figure 4 and Figure 6 When the plunger 94 is pushed with sufficient force to raise the pressure in the auxiliary fluid chamber 142 to a level higher than the buckling pressure P of the floating plug 100,B 122 and the skirt 126 rotates / folds about the latter's skirt hinge 124. As the plunger 94 is further advanced, the barrel protrusion 132 enters the now-opened central slit 122, thereby allowing fluid in the auxiliary fluid chamber 142 to flow through the fluid passage 136 and the outlet lumen 90. Further advancement of the plunger 94 discharges the fluid out of the auxiliary chamber 142 through the outlet lumen. The entry of the barrel protrusion 132 into the central slit 122 effectively prevents the dome-shaped diaphragm from completely relaxing back to its initial state. Instead, the diaphragm wall 113 flexibly conforms to abutting contact with the tapered sidewall 133 of the barrel protrusion 132. Therefore, the subsequent reduction in the advancing force and pressure applied to the plunger 94 can be reduced to below the buckling pressure P B , while still draining fluid from the auxiliary chamber 142.

[0107] In one or more embodiments, the main chamber 140 is pre-filled or filled on-site with a desired medicament. In one or more embodiments, the auxiliary chamber 142 is pre-filled with a desired amount of saline flushing fluid. In one or more embodiments, the auxiliary chamber 142 is filled with a desired medicament. In one or more embodiments, both the main chamber 140 and the auxiliary chamber 142 are filled with a desired medicament. In one or more embodiments, both the main chamber 140 and the auxiliary chamber 142 are filled with a desired amount of saline flushing fluid. In one or more embodiments, the main chamber 140 and / or the auxiliary chamber 142 are pre-filled with fluid using a sterile filling method during or after the assembly of the syringe 80. 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 a capped connector 88 is used to reconstitute a powdered medicament that has been pre-filled in the main chamber 140 by dispersing the pre-filled dilution liquid stored in the auxiliary chamber 142 into the main chamber before the connector is uncovered.

[0108] In other applications, such as Figures 4 to 10 As shown, medication is drawn and dispensed into the VAD through the primary chamber 140, and the VAD is subsequently flushed by a flushing solution prefilled in the auxiliary chamber 142 during organization of the syringe 80. A removable C-shaped collar 144 is applied around the exposed portion of the plunger 94 to prevent inadvertent advancement thereof and inadvertent expulsion of the flushing solution from the syringe 80. The collar 144 is removed by the administering health care professional prior to use of the syringe.

[0109] Figures 7 to 10 The functional operation of the syringe 80 is depicted with the auxiliary fluid chamber 142 pre-filled with a fluid (such as a flushing fluid) and the main chamber 140 empty. Figure 7In the embodiment of the present invention, the administering health care professional removes the collar 144, thereby allowing the plunger 94 to be manipulated throughout its range of motion. The extended skirt 126 of the floating stopper 100 prevents the barrel projection 132 from being inserted into the dome-shaped septum 110. Although not shown in the figures, the health care professional secures the needle to the Luer connector 88 for use in drawing the desired medication from a vial or other container into the empty main chamber 140 of the syringe 80. In the embodiment of the present invention, the administering health care professional removes the collar 144, thereby allowing the plunger 94 to be manipulated throughout its range of motion. The extended skirt 126 of the floating stopper 100 prevents the barrel projection 132 from being inserted into the dome-shaped septum 110. Although not shown in the figures, the health care professional secures the needle to the Luer connector 88 for use in drawing the desired medication from the vial or other container into the empty main chamber 140 of the syringe 80. Figure 8 In the embodiment of the present invention, plunger 94 is retracted in the direction of arrow R, which draws the drug from the bottle into primary fluid chamber 140. The drug is infused from primary chamber 140 into the patient's previously flushed VAD by advancing plunger 94 in the direction of arrow A with sufficient pressure below the buckling pressure of dome-shaped diaphragm 110 to empty the primary chamber while maintaining the diaphragm in its first relaxed state ( Figure 5 ). After the drug is administered to the patient, the buckling pressure P of the dome-shaped diaphragm 110 is exceeded. B The plunger rod 94 is advanced with sufficient force A to flush the VAD with a flushing solution (e.g., saline or heparin) prepackaged in the auxiliary chamber 142. Once the flushing procedure is completed, the syringe 80 is withdrawn from the VAD.

[0110] The syringe embodiments disclosed herein are constructed of medical grade materials known to those skilled in the art. In certain embodiments, the barrel, plunger and shaft are made of polypropylene polymers. The seal is made of fiber-filled polytetrafluoroethylene (PTFE) polymers. The stopper is made of polyisoprene polymers.

[0111] In this specification, references to "one embodiment", "certain embodiments", "various embodiments", "one or more embodiments" or "embodiments" mean that the specific features, structures, materials or characteristics described in conjunction with the embodiments are included in at least one embodiment of the present disclosure. Therefore, the appearance of phrases (such as "in one or more embodiments", "in certain embodiments", "in various embodiments", "in one embodiment" or "in an embodiment") in different places throughout this specification does not necessarily refer to the same embodiment of the present disclosure. In addition, in one or more embodiments, specific features, structures, materials or characteristics can be combined in any suitable manner. In addition, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered as limiting. The use of "including", "comprising" or "having" and its variations herein is meant to cover the items listed thereafter and their equivalents and additional items. Unless otherwise specified or limited, the terms "mounting", "connecting", "supporting" and "coupling" and their variations should be interpreted broadly; they include direct and indirect mounting, connection, support and coupling. In addition, "connecting" and "coupling" are not limited to physical, mechanical or electrical connections or couplings.

[0112] Although the disclosure herein provides descriptions with reference to embodiments, it should be understood that these embodiments are merely illustrations of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and variations 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, characterized in that: The syringe comprises: a cylindrical barrel defining a first inner sidewall, 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 an interior of the barrel defined by the open proximal end of the barrel, the distal end, and the first inner sidewall; a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the barrel interior and selectively translatable along its axis within the barrel interior; a plunger stopper coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel; An integral unitary structure floating stopper oriented within the barrel interior and capable of translating between the plunger stopper and the distal end of the barrel, the floating stopper having a drum-shaped sidewall defining an internal stopper cavity in open communication with a first axial end thereof, a second axial end of the drum-shaped sidewall being joined to a peripheral base of a dome-shaped diaphragm defining an apex, the wall forming the diaphragm having a first face in communication with the internal stopper cavity and a second face, the diaphragm wall further defining a central slit piercing both the first face and the second face thereof at the apex, the dome-shaped diaphragm wall further defining a central slit piercing both the first face and the second face thereof at the apex, the dome-shaped diaphragm wall further defining a central slit piercing both the first face and the second face thereof at the apex, the dome-shaped diaphragm wall being connected to a peripheral base of a dome-shaped diaphragm defining an apex said diaphragm wall of the dome-shaped diaphragm forms a bistable valve, said bistable valve closing said central slit by compression in its meridional dimension when said diaphragm is in a first relaxed state, and opening said central slit when said diaphragm flexes under tension in said meridional dimension in a second state, said open central slit allowing pressurized fluid to flow from said internal stopper cavity out of said second face of said diaphragm, wherein flexure of said diaphragm wall is caused solely by a higher differential pressure of fluid in said stopper internal cavity on said first face than on its second face, said diaphragm wall having no physical contact with any structure within said syringe; a primary fluid chamber defined within the barrel interior between the diaphragm and the outlet lumen of the floating plug, 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 an auxiliary fluid chamber defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper, the auxiliary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the auxiliary fluid chamber being selectively variable by translation of the plunger; wherein, when the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger draws fluid into or dispenses fluid out of the main fluid chamber only via the outlet lumen; and wherein, when the central slit of the diaphragm is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to cause the wall of the dome-shaped diaphragm to flex into its second state, the auxiliary fluid chamber is fluidically connected to the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses the fluid out of the auxiliary fluid chamber via the outlet lumen.

2. The syringe according to claim 1, characterized in that Also included is that the first face of the diaphragm wall defines notches that diverge outwardly from the central slit toward the first axial end of the floating plug.

3. The syringe according to claim 1, characterized in that wherein the dome-shaped diaphragm flexes from its first, relaxed state to its second state when a fluid differential pressure greater than about 30 pounds per square inch (2.07 bar) is applied within the plug interior cavity.

4. The syringe according to claim 1, characterized in that The floating plug also includes a skirt having a first axial face concentrically connected to the second face of the diaphragm wall by an annular skirt hinge surrounding the central slit of the diaphragm wall, and a second axial face extending from the skirt hinge in an opposite orientation to the distal end of the barrel, whereby flexion of the diaphragm wall to its second state causes the skirt to fold or pivot about the annular skirt hinge toward the second face of the diaphragm wall.

5. The syringe according to claim 4, characterized in that Also included is a protrusion formed at the distal end of the barrel, the protrusion extending inwardly toward the dome-shaped diaphragm of the floating plug, coaxial with the barrel axis, and received in the central slit when the diaphragm wall is in its second state.

6. The syringe according to claim 5, characterized in that The projection also includes a blunt-tipped tube in fluid communication with the outlet lumen of the connector.

7. The syringe according to claim 1, characterized in that Also included is a protrusion formed at the distal end of the barrel, the protrusion extending inwardly toward the dome-shaped diaphragm of the floating plug, coaxial with the barrel axis, and received in the central slit when the diaphragm wall is in its second state.

8. The syringe according to claim 1, characterized in that Also included is that the first face of the diaphragm wall defines the apex of the dome-shaped diaphragm.

9. The syringe according to claim 1, characterized in that Also included is that the second side of the diaphragm wall defines the apex of the dome-shaped diaphragm.

10. A syringe, characterized in that: The syringe comprises: a cylindrical barrel defining a first inner sidewall, 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 an interior of the barrel defined by the open proximal end of the barrel, the distal end, and the first inner sidewall; a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the barrel interior and selectively translatable along its axis within the barrel interior; a plunger stopper coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel; an integral unitary structure floating stopper oriented within the barrel interior and capable of translating between the plunger stopper and the distal end of the barrel, the floating stopper having a drum-shaped sidewall defining an internal stopper cavity in open communication with a first axial end thereof, a second axial end of the drum-shaped sidewall being joined by an intermediate annular flexible hinge to a peripheral base of a dome-shaped diaphragm defining an apex, the wall forming the diaphragm having a first face in communication with the internal stopper cavity and a second face, the diaphragm wall defining a central slit piercing both the first face and the second face thereof at the apex; said diaphragm wall of said dome-shaped diaphragm forming a bistable valve, said bistable valve closing said central slit by compression in its meridional dimension when said diaphragm is in a first relaxed state wherein said apex is closer to said first axial end of said drum-shaped sidewall, and opening said central slit when said diaphragm flexes under tension in said meridional dimension in a second state wherein said apex is further away from said first axial end of said drum-shaped sidewall, the open central slit permitting pressurized fluid to flow from said internal stopper cavity out of said second face of said diaphragm, wherein flexing of said diaphragm wall is caused solely by a higher differential pressure of fluid in said stopper internal cavity on said first face than on its second face, said diaphragm wall having no physical contact with any structure within said syringe; a primary fluid chamber defined within the barrel interior between the diaphragm and the outlet lumen of the floating plug, 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 an auxiliary fluid chamber defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper, the auxiliary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the auxiliary fluid chamber being selectively variable by translation of the plunger; wherein, when the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger draws fluid into or dispenses fluid out of the main fluid chamber only via the outlet lumen; and wherein, when the central slit of the diaphragm is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to cause the wall of the dome-shaped diaphragm to flex into its second state, the auxiliary fluid chamber is fluidically connected to the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses the fluid out of the auxiliary fluid chamber via the outlet lumen.

11. The syringe according to claim 10, characterized in that Also included is that the first face of the diaphragm wall defines notches that diverge outwardly from the central slit toward the first axial end of the floating plug.

12. The syringe according to claim 10, characterized in that wherein the dome-shaped diaphragm flexes from its first, relaxed state to its second state when a fluid differential pressure greater than about 30 pounds per square inch (2.07 bar) is applied within the plug interior cavity.

13. The syringe according to claim 10, characterized in that Also included is that the thickness of the diaphragm wall increases from the base to the apex of the dome-shaped diaphragm.

14. The syringe according to claim 10, characterized in that Also included is that the first face of the diaphragm wall defines the apex of the dome-shaped diaphragm.

15. A syringe, characterized in that: The syringe comprises: a cylindrical barrel defining a first inner sidewall, 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 an interior of the barrel defined by the open proximal end of the barrel, the distal end, and the first inner sidewall; a plunger having a proximal end and a distal end, the distal end of the plunger being disposed within the barrel interior and selectively translatable within the barrel interior along a barrel axis thereof; a plunger stopper coupled to the distal end of the plunger, the plunger stopper having a distal end surface facing the distal end of the barrel; An integral unitary structure floating stopper oriented within the barrel interior and capable of translating between the plunger stopper and the distal end of the barrel, the floating stopper having a drum-shaped sidewall defining an internal stopper cavity in open communication with a first axial end thereof, a second axial end of the drum-shaped sidewall being joined to a peripheral base of a dome-shaped diaphragm defining an apex, a wall forming the diaphragm having a first face in communication with the internal stopper cavity and a second face in an opposite orientation to the distal end of the barrel, the diaphragm wall defining a central slit piercing both the first face and the second face thereof at the apex, the floating stopper further defining a skirt having a first axial face concentrically connected to the second face of the diaphragm wall by an annular skirt hinge surrounding the central slit of the diaphragm wall, and a peripheral base of the diaphragm wall defining an apex. a second axial face extending from said skirt hinge in an opposite orientation, said diaphragm wall of said dome-shaped diaphragm forming a bistable valve, said bistable valve closing said central slit by compression in its warp dimension when said diaphragm is in a first relaxed state wherein said apex is closer to said first axial end of said drum-shaped sidewall, and opening said central slit when said diaphragm flexes under tension in said warp dimension in a second state wherein said apex is further from said first axial end of said drum-shaped sidewall, the open central slit permitting pressurized fluid to flow from said internal stopper cavity out of said second face of said diaphragm, wherein flexing of said diaphragm wall is caused solely by a higher differential pressure of fluid in said stopper internal cavity on said first face than on its second face, said diaphragm wall having no physical contact with any structure within said syringe; a primary fluid chamber defined within the barrel interior between the diaphragm and the outlet lumen of the floating plug, 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 an auxiliary fluid chamber defined within the barrel interior between the distal end surface of the plunger stopper and the diaphragm of the floating stopper, the auxiliary fluid chamber being in fluid communication with the central slit of the diaphragm, the volume and fluid pressure within the auxiliary fluid chamber being selectively variable by translation of the plunger; wherein, when the central slit of the diaphragm is closed, the auxiliary fluid chamber is isolated from the outlet lumen, so that translation of the plunger draws fluid into or dispenses fluid out of the main fluid chamber only via the outlet lumen; and wherein, when the central slit of the diaphragm is opened by increasing the fluid differential pressure in the auxiliary fluid chamber and in the internal cavity of the stopper sufficient to flex the wall of the dome-shaped diaphragm into its second state, the skirt folds or pivots about the annular skirt hinge toward the second face of the diaphragm wall, and the auxiliary fluid chamber is in fluid communication with the outlet lumen, so that further translation of the plunger toward the distal end of the barrel dispenses fluid out of the auxiliary fluid chamber via the outlet lumen.

16. The syringe according to claim 15, characterized in that wherein the dome-shaped diaphragm flexes from its first, relaxed state to its second state when a fluid differential pressure greater than about 30 pounds per square inch (2.07 bar) is applied within the plug interior cavity.

17. The syringe according to claim 15, characterized in that The skirt of the floating plug also includes a frustoconical skirt having a first axial face of narrower diameter concentrically connected to the second face of the diaphragm wall by the annular skirt hinge surrounding the central slit of the diaphragm wall, and a diverging second axial face extending from the skirt hinge in an opposite orientation to the distal end of the barrel, so that flexure of the diaphragm wall to its second state causes the skirt to fold or pivot about the annular skirt hinge toward the second face of the diaphragm wall.

18. The syringe according to claim 17, characterized in that Also included is that the second face of the diaphragm wall defines a recessed portion for receiving the folded or pivoted skirt when the diaphragm wall is flexed to its second state.

19. The syringe according to claim 18, characterized in that Wherein when the septum wall is in its first state, the skirt blocks contact between the central slit and the distal end of the barrel.

20. The syringe according to claim 18, characterized in that Also included is a protrusion formed at the distal end of the barrel, the protrusion extending inwardly toward the dome-shaped diaphragm of the floating plug, coaxial with the barrel axis, and received in the central slit when the diaphragm wall is in its second state.

21. The syringe according to claim 20, characterized in that The projection also includes a blunt-tipped tube in fluid communication with the outlet lumen of the connector.

22. The syringe according to claim 15, characterized in that Also included is that the second face of the diaphragm wall defines a recessed portion for receiving the folded or pivoted skirt when the diaphragm wall is flexed to its second state.

23. The syringe according to claim 15, characterized in that Wherein when the septum wall is in its first state, the skirt blocks contact between the central slit and the distal end of the barrel.

24. The syringe according to claim 15, characterized in that Also included is a protrusion formed at the distal end of the barrel, the protrusion extending inwardly toward the dome-shaped diaphragm of the floating plug, coaxial with the barrel axis, and received in the central slit when the diaphragm wall is in its second state.

25. The syringe according to claim 24, characterized in that The projection also includes a blunt-tipped tube in fluid communication with the outlet lumen of the connector.

26. The syringe according to claim 24, characterized in that Also included is that the peripheral surface of the tube defines a through hole, and the through hole is used to establish fluid communication between the interior of the tube and the outlet tube cavity of the connector.

27. The syringe according to claim 15, characterized in that Also included is that the second side of the diaphragm wall defines the apex of the dome-shaped diaphragm.

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