Sequential drug delivery syringe

Abstract

The utility model relates to a sequential drug delivery syringe. A dual chamber, sequential delivery syringe facilitates selective drug mixing, dispensing, and administration through a catheter or other vascular access device (VAD), as well as post-administration irrigation of the catheter with a single syringe instrument. The syringe barrel contains an outlet, such as a luer connector, a variable volume primary chamber, and a secondary chamber pre-filled with a fluid. A plunger-manipulated telescopic actuator, in combination with a drug stop disposed inside the barrel, forms a valve for selectively isolating the secondary fluid chamber from the primary fluid chamber and / or the outlet fluid communication of the syringe barrel. The valve opening is automatically accomplished by continuous advancement of the plunger.

Description

Technical Field

[0001] The present disclosure generally relates to dual-chamber, sequential drug delivery syringes for administering two fluids, or for administering and flushing catheters and other vascular access devices (VADs), or for mixing and administering fluids, and methods for sequential drug delivery via a single syringe. Background Art

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

[0003] VAD practice standards generally recommend flushing procedures after catheter placement, before infusion, and before and after medication administration, blood sampling, transfusion, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid medication incompatibilities, ensure administration of complete medication doses, prevent thrombosis, and minimize the risk of bloodstream infection. Flushing procedures require different types and amounts of flushing solutions. Commonly used flushing solutions are normal saline and / or heparin lock solutions. The type and amount of flushing solution varies depending on the specific type of catheter. The volume of flushing solution is between 5 ml and 10 ml is most common, 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 be terminated by a port or valve. The most common port type is covered by a penetrable septum or a pre-cut septum and is known in the art and is sometimes referred to as "PRN" from the Latin "pro re nata", meaning "as needed". The septum is preferably made of rubber or another elastomeric material that allows the insertion of a sharp needle cannula to inject fluid or withdraw fluid from the catheter. When the needle cannula is withdrawn, the septum seals itself. The port with a pre-cut septum is used with a blunt cannula or a truncated conical tip of a syringe barrel. Gently push the syringe tip or blunt cannula (which is usually attached to a syringe) through the pre-cut septum to establish fluid communication.

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

[0006] Removal of debris or residue is called "purging" or "flushing" and prevents the accumulation of blood, blood residue, and IV medications within the catheter or other VAD device. Such accumulation can lead to partial or complete blockage of the fluid pathway in the catheter system and can also require expensive and potentially dangerous procedures to purge the affected catheter or replace the catheter entirely. Often, such blockages can result in interruptions in treatment, compromising patient care. The accumulation of residue within the catheter can also increase the risk of infection by providing a breeding ground for microorganisms.

[0007] As will be appreciated by those skilled in the art, the flushing technique involves injecting a flushing solution, such as a saline solution, into the VAD to clear debris and blockages. The injection is typically accomplished by advancing a plunger rod into a pre-filled syringe barrel, thereby expelling the flushing solution into the VAD. When this technique is used in conjunction with a catheter, turbulence is introduced into the catheter, thereby dislodging any debris or residue attached to the catheter. The flushing technique requires applying a substantially constant pressure or force to the plunger rod in the distal direction. Conventional or smooth flushing techniques may also include applying a substantially linearly increasing or decreasing pressure or force to the plunger rod in the distal direction.

[0008] After flushing, the practitioner can then administer a dose of a medical fluid, which is either in a vial and needs to be drawn from the vial, 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 transmitting catheter-related bloodstream infections (CRBSIs), which can be expensive and potentially fatal. In order to reduce cases of CRBSIs and ensure proper use and maintenance of VADs, standards of practice have been developed that include disinfection and cleaning procedures.

[0009] The IV flush following the administration of an IV medication is commonly performed using two separate syringes in clinical practice. The flush is performed after medication administration because residual medication may remain in the luer portion of the drug delivery syringe and in the catheter. Without a subsequent flushing procedure, the full medication dose may not be delivered to the patient. Some medications are sensitive to the time of administration and should not be left in the catheter until a subsequent medication administration flushes the residual amount of the previous medication through the line. The use of a second syringe for a sequential flush is intended to address the issue of residual medication delivery, but the use of a second flush syringe has certain disadvantages, namely: potential errors in delivering medication and the inability to follow up medication delivery using the flushing procedure. Potential medication delivery is possible because the most commonly used flushing solutions are colorless, as are saline and other flushing solutions. If the healthcare professional is distracted during the procedure, there is a possibility that the flushing solution may not be delivered after medication delivery.

[0010] There is a need for a syringe assembly that has 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 single syringe for intravenous flushing after administration of an intravenous medication to increase clinician efficiency and reduce costs associated with maintaining syringe inventory and medical waste disposal. There is also an additional need for a separate syringe for mixing a drug in powder form and then administering the mixed drug to a patient. Utility Model Content

[0011] A dual-chamber, sequential drug delivery syringe facilitates selective drug mixing, dispensing and administration through a catheter or other vascular access device (VAD), as well as post-administration flushing of the catheter with a single syringe device. The syringe disclosed herein is used as a sequential syringe, wherein saline or other flushing fluid is pre-filled in one chamber, and the other chamber is pre-filled with medication or filled on-site by a medical professional. In other embodiments, the sequential drug delivery syringe is used as a drug mixing syringe, pre-filled with saline or another diluent in one chamber and pre-filled with powder / lyophilized medication in the other chamber. The syringe barrel includes an outlet, such as a Luer connector, a primary fluid chamber, and a secondary fluid chamber. A telescopic actuator assembly, which is coupled to a plunger stop, serves as an isolation valve for selectively opening or blocking a through passage formed in the drug stop. The telescopic actuator assembly selectively isolates the secondary chamber from the main chamber only by advancement of the syringe plunger. In medical procedures requiring both flushing and administration of medication through a catheter or other VAD, the use of syringes of the type disclosed herein reduces the need for 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 the time required for clinicians to complete related medical procedures.

[0012] One aspect of the present disclosure relates to a sequential delivery syringe comprising a hollow syringe barrel defining an inner wall, a proximal barrel end, and a distal barrel end. The distal end of the barrel includes a connector defining an outlet chamber extending through the connector. The outlet chamber 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 inner sidewall of the barrel. The syringe includes a plunger disposed with the barrel interior, the plunger having a distal end and a proximal end extending outside the proximal end of the barrel. The syringe includes a secondary stopper or saline stopper disposed within the barrel interior, the secondary stopper or saline stopper having a proximal axial end coupled to the distal end of the plunger and a distal axial end defining a distal cavity. A primary stopper or drug stopper is disposed within the barrel interior between the secondary stopper and the distal end of the barrel. The primary stopper or drug stopper has a proximal axial end defining a proximal cavity, a distal axial end defining a distal cavity having a seat surface, and a through-channel defining a fluid connection with both the proximal cavity and the distal cavity of the primary stopper. A telescopic actuator assembly is oriented with the respective cavities of the primary stopper and the secondary stopper. The actuator assembly acts as a valve to isolate the proximal cavity of the primary stopper from its distal cavity. The actuator assembly includes a reciprocating actuator oriented within the through-channel of the primary stopper. The actuator protrudes into the proximal cavity and the distal cavity of the primary stopper / drug stopper and has: an outer peripheral surface that engages the through-channel in a sliding, frictional manner; and a radially protruding proximal axial face that is oriented within the corresponding distal cavity of the primary stopper, opposite to the orientation of the seat surface. The actuator assembly also includes a tube having: an outer peripheral surface coupled to and within the distal cavity of the secondary stop; and an inner wall that limits the outer peripheral surface of the actuator and engages with the outer peripheral surface of the actuator in a sliding, frictional manner. The syringe has a primary fluid chamber inside the barrel, the primary fluid chamber being defined between the distal end surface of the primary stop and an outlet chamber at the distal end of the barrel. The volume of the primary fluid chamber can be selectively changed by translation of the plunger. The syringe has a secondary fluid chamber inside the barrel, the secondary fluid chamber being defined between the distal end surface of the secondary stop and the through passage of the primary stop. When the proximal axial face of the actuator is spaced apart from the seat surface of the primary stop, the volume of the secondary fluid chamber can be selectively changed by translation of the plunger. In this syringe embodiment, when the proximal axial face of the actuator is spaced apart from the seat surface of the main stopper, the secondary fluid chamber is in fluid communication with the main fluid chamber and the outlet chamber of the syringe, and when the proximal axial face of the actuator is in abutting contact with the seat surface of the main stopper, the secondary fluid chamber is isolated from the main fluid chamber. When the syringe is used, withdrawing the plunger tensions the telescopic actuator assembly, which reciprocates the proximal axial face of the actuator into abutting contact with the seat surface of the main stopper and withdraws the drug stopper / main stopper.When the syringe is used, the plunger advances the primary stop or the drug stop alone, causing the proximal axial surface of the actuator to reciprocate and disengage from abutment contact with the seat surface of the primary stop, advancing the secondary stop or the saline stop, and collapsing the telescopic actuator assembly within the corresponding distal cavity of the secondary stop and the proximal cavity of the primary stop.

[0013] In some embodiments of the syringe disclosed herein, its secondary chamber is pre-filled with a flushing solution. Ideally, a clinician can administer medication into a patient's VAD with the primary chamber and immediately flush the VAD with the secondary chamber without removing the syringe from the VAD. In embodiments of the syringe disclosed herein, a clinician can administer medication through the VAD and then immediately flush the VAD with a single, continuous advancement of a single plunger.

[0014] Another aspect of the present disclosure relates to a sequential drug delivery syringe. The syringe includes a hollow syringe barrel defining an inner wall, a proximal barrel end, and a distal barrel end. The distal end of the barrel includes a connector defining an outlet chamber therethrough, the outlet chamber being in fluid communication with the interior of the barrel. The interior of the barrel is defined by an open proximal end, a distal end, and an inner sidewall. A plunger is disposed with the barrel interior, the plunger having a distal end and a proximal end extending outside the proximal end of the barrel. A secondary stopper or saline stopper is disposed within the barrel interior, the secondary stopper or saline stopper having a proximal axial end coupled to the distal end of the plunger, and a distal axial end defining a distal cavity therein. A primary stopper or drug stopper is disposed within the barrel interior between the secondary stopper and the distal end of the barrel. The primary stopper has a proximal axial end defining a proximal cavity, a distal axial end defining a distal cavity having a seat surface, and a through passage in fluid communication with both the proximal cavity and the distal cavity. The syringe also has a telescoping actuator assembly oriented with the respective cavities of the primary and secondary stops. The telescoping actuator assembly includes a plurality of nested tubes that are slidably and frictionally engaged with each other; each nested tube has an outer peripheral surface and an inner wall, respectively. The outer peripheral surface of the most proximally oriented of the nested tubes is coupled to the distal cavity of the secondary stop and within the distal cavity, while its inner wall is slidably and frictionally engaged with the outer peripheral surface of the adjacent tube captured therein. The reciprocating actuator is oriented within the through passage of the primary stop. The actuator includes a collet bushing having an annular bushing edge, the radially protruding proximal axial face of the annular bushing edge being in opposite orientation to the matching, annular seat surface of the primary stop. The collet bushing has a plurality of collet bushing fingers that protrude away from the proximal axial face of the annular bushing edge and are in frictional contact with the surface defining the through passage. The distal tip of each bushing finger protrudes into the proximal cavity of the main stop. The distal tip of the bushing finger is coupled to a platform oriented on the distal end of the actuator shaft. The outer surface of the proximal end of the actuator shaft engages with the inner wall of the most distally oriented tube in a sliding frictional manner. The seat surface of the main stop is captured between the collet bushing and the platform. The syringe defines a primary fluid chamber inside the barrel between the distal end surface of the main stop and the outlet chamber at the distal end of the barrel. The volume of the primary fluid chamber can be selectively changed by translation of the plunger. The syringe defines a secondary fluid chamber inside the barrel between the distal end surface of the secondary stop and the through passage of the main stop. When the proximal axial face of the annular bushing edge of the collet bushing is spaced apart from the seat surface of the main stop, the volume of the secondary fluid chamber can be selectively changed by translation of the plunger.In the present syringe, when the proximal axial surface of the annular bushing edge of the collet bushing is spaced from the seat surface of the main stopper, the secondary fluid chamber is in fluid communication with the main fluid chamber and the outlet chamber of the syringe, and when the proximal axial surface of the annular bushing edge is in abutment contact with the seat surface of the main stopper, the secondary fluid chamber is isolated from the main fluid chamber. When the syringe is used, the plunger is withdrawn to tension the telescopic actuator assembly, which reciprocates the proximal axial surface of the collet bushing into abutment contact with the seat surface of the main stopper and withdraws the stopper. When the syringe is in use, the advancement of the plunger advances the main stopper alone, reciprocates the proximal axial surface of the collet bushing of the actuator out of abutment contact with the seat surface of the main stopper, advances the secondary stopper, and collapses the telescopic actuator assembly in the respective distal cavities of the secondary stopper and the proximal cavity of the main stopper.

[0015] In some syringe embodiments of the present disclosure, a barrel ring protruding radially inward is formed on the inner wall of the barrel, and a path seal prevents fluid from flowing back from the main chamber to the secondary chamber. The path seal has an inner peripheral surface that limits the outer surface of the tube of the actuator assembly, and the outer peripheral surface is in fluid-tight contact with the proximal cavity of the main stopper.

[0016] Other aspects of the present disclosure relate to a method for manufacturing the sequential delivery syringe disclosed herein by inserting collet bushing fingers into the through passages of the primary stop so that they protrude into the proximal cavity. After inserting the collet bushing, the platform of the actuator assembly is coupled to the tips of the collet bushing fingers, thereby capturing the primary stop between the annular edge of the collet bushing and the cross-shaped platform. Next, before or after coupling the plunger to the secondary stop, the most proximal-oriented tube of the actuator assembly is coupled within the distal cavity of the secondary stop. The now coupled primary stop, actuator assembly, secondary stop, and plunger are inserted into the interior of the syringe barrel.

[0017] The various aspects of the disclosure and the individual features of the exemplary embodiments described herein may be applied together or separately in any combination or sub-combination.

[0018] In some embodiments, the present application relates to a sequential drug delivery syringe, the sequential drug delivery syringe comprising:

[0019] a hollow syringe barrel defining an inner wall, a proximal barrel end, and a distal barrel end, the distal end of the barrel including a connector defining an outlet chamber therethrough, the outlet chamber being in fluid communication with an interior of the barrel defined by the open proximal end, the distal end, and the inner sidewall;

[0020] a plunger disposed with the barrel interior, the plunger having a proximal end extending outside the proximal end of the barrel, and a distal end;

[0021] a secondary stopper disposed within the barrel interior, the secondary stopper having: a proximal axial end coupled to the distal end of the plunger, and a distal axial end defining a distal cavity therein;

[0022] a primary stop disposed within the barrel between the secondary stop and the distal end of the barrel, the primary stop having a proximal axial end defining a proximal cavity, a distal axial end defining a distal cavity having a seat surface, and a through passage defining fluid communication with both the proximal cavity and the distal cavity of the primary stop;

[0023] a telescoping actuator assembly oriented with the respective cavities of the primary and secondary stops, the telescoping actuator assembly having:

[0024] a reciprocating actuator oriented within the through passage of the primary stop, the actuator projecting into the proximal cavity and the distal cavity of the stop and having: an outer peripheral surface that engages the through passage in a sliding, frictional manner; and a radially projecting proximal axial face oriented within a corresponding distal cavity of the primary stop opposite to the orientation of the seat surface, and

[0025] a tube having an outer peripheral surface coupled to and within the distal cavity of the secondary stop and an inner wall constraining and slidingly, frictionally engaging the outer peripheral surface of the actuator;

[0026] a primary fluid chamber within the barrel interior, the primary fluid chamber being defined between the distal end surface of the primary stopper and the outlet chamber at the distal end of the barrel, the volume of the primary fluid chamber being selectively variable by translation of the plunger; and

[0027] a secondary fluid chamber within the barrel interior, the secondary fluid chamber being defined between a distal end surface of the secondary stop and the through passage of the primary stop, the volume of the secondary fluid chamber being selectively variable by translation of the plunger when the proximal axial face of the actuator is spaced apart from the seat surface of the primary stop;

[0028] wherein the secondary fluid chamber is in fluid communication with the primary fluid chamber and the outlet chamber of the syringe when the proximal axial face of the actuator is spaced apart from the seat surface of the primary stopper, and the secondary fluid chamber is isolated from the primary fluid chamber when the proximal axial face of the actuator is in abutting contact with the seat surface of the primary stopper;

[0029] wherein withdrawing the plunger tensions the telescopic actuator assembly, reciprocates the proximal axial surface of the actuator into abutting contact with a seat surface of the main stop, and withdraws the stop; and

[0030] Wherein, the plunger alone pushes the main stopper, causing the proximal axial surface of the actuator to reciprocate and disengage from the abutment contact with the seat surface of the main stopper, pushing the secondary stopper, and causing the telescopic actuator assembly to collapse within the corresponding distal cavity of the secondary stopper and the proximal cavity of the main stopper.

[0031] In some embodiments, the actuator assembly also includes a plurality of nested tubes that are slidably and frictionally engaged with each other, each of the nested tubes having an outer peripheral surface and an inner wall; the outer peripheral surface of the most proximal nested tube is coupled to the distal cavity of the secondary stop and within the distal cavity, wherein its inner wall is slidably and frictionally engaged with the outer peripheral surface of an adjacent tube captured therein; and the inner wall of the most distally oriented nested tube limits the outer peripheral surface of the actuator and is slidably and frictionally engaged with the outer peripheral surface of the actuator.

[0032] In some embodiments, the actuator further comprises: a collet bushing having an annular bushing edge, a radially protruding proximal axial face of the annular bushing edge being in an opposite orientation to the seat surface of the main stop; a plurality of collet bushing fingers protruding away from the proximal axial face of the annular bushing edge, the plurality of collet bushing fingers being in frictional contact with a surface defining the through passage, a distal tip of each bushing finger protruding into the proximal cavity of the main stop.

[0033] In some embodiments, the actuator further comprises: the distal tip of the collet bushing finger coupled to a platform of the distal end of the actuator shaft; the outer surface of the proximal end of the actuator shaft slidingly frictionally engaging the inner wall of the distal-most directed tube, the seat surface of the primary stop being captured between the collet bushing and the platform.

[0034] In some embodiments, at least one of the collet bushing fingers defines a circumferential flange projecting radially outwardly, the circumferential flange being in frictional contact with a surface defining the through passage.

[0035] In some embodiments, the collet bushing includes four evenly circumferentially spaced collet fingers rigidly coupled to corresponding cross-shaped platforms of the actuator, and the proximal outer surface of the actuator shaft defines a spherical surface profile for frictionally engaging a corresponding inner wall surface of the distal-most directed tube.

[0036] In some embodiments, the syringe further comprises three nested tubes, the most proximal oriented nested tube defining a peripheral flange at its distal end, the peripheral flange matingly engaging with a corresponding circumferential groove defined within the distal cavity of the secondary stop, and the inner wall surface of the most distal oriented nested tube being in frictional engagement with the spherical surface of the actuator shaft.

[0037] In some embodiments, the actuator further comprises: a collet bushing having an annular bushing edge, a radially protruding proximal axial face of the annular bushing edge being in an opposite orientation to the seat surface of the main stop; a plurality of collet bushing fingers protruding away from the proximal axial face of the annular bushing edge, the plurality of collet bushing fingers being in frictional contact with a surface defining the through passage, a distal tip of each bushing finger protruding into the proximal cavity of the main stop.

[0038] In some embodiments, the actuator further comprises: the distal tip of the collet bushing finger coupled to a platform of the distal end of the actuator shaft; an outer surface of the proximal end of the actuator shaft slidingly frictionally engaged with the inner wall of the tube, the seat surface of the main stop being captured between the collet bushing and the platform.

[0039] In some embodiments, at least one of the collet bushing fingers defines a circumferential flange projecting radially outwardly, the circumferential flange being in frictional contact with a surface defining the through passage.

[0040] In some embodiments, the collet bushing includes four evenly circumferentially spaced collet fingers rigidly coupled to corresponding cross-shaped platforms of the actuator, and the proximal outer surface of the actuator shaft defines a spherical surface profile for frictionally engaging a corresponding inner wall surface of the tube.

[0041] In some embodiments, the syringe further comprises: a barrel ring formed on the inner wall of the barrel and protruding radially inward; and a path seal having an inner circumferential surface and an outer circumferential surface, wherein the inner circumferential surface limits the outer surface of the tube of the actuator assembly, the outer circumferential surface is in fluid-tight contact with the proximal cavity of the main stopper, and the path seal prevents fluid from flowing back from the main chamber to the secondary chamber.

[0042] In some embodiments, the syringe further comprises a dry or powdered drug in the primary chamber, and a drug diluent in the secondary chamber thereof.

[0043] In some embodiments, the distal end of the main stop and the distal end of the syringe barrel have corresponding, matching contours that contact each other when the main stop is fully inserted into the interior of the syringe barrel, thereby minimizing the volume of the main fluid chamber.

[0044] In some embodiments, the proximal end of the primary stop and the distal end of the secondary stop have corresponding, matching profiles that contact each other when the secondary stop is fully inserted into the interior of the syringe barrel, thereby minimizing the volume of the secondary fluid chamber.

[0045] In some embodiments, the syringe further comprises a flushing fluid in the secondary chamber thereof.

[0046] In some embodiments, advancement of the plunger under a first axial pressure advances the main stop, and advancement of the plunger under a second axial pressure greater than the first pressure causes the proximal axial surface of the actuator to reciprocate away from abutting contact with the seat surface of the main stop, which establishes fluid communication between the secondary fluid chamber, the main fluid chamber, and the outlet chamber and advances the secondary stop.

[0047] In some embodiments, the present application relates to a sequential drug delivery syringe, the sequential drug delivery syringe comprising:

[0048] a hollow syringe barrel defining an inner wall, a proximal barrel end, and a distal barrel end, the distal end of the barrel including a connector defining an outlet chamber therethrough, the outlet chamber being in fluid communication with an interior of the barrel defined by the open proximal end, the distal end, and the inner sidewall;

[0049] a plunger disposed with the barrel interior, the plunger having a distal end and a proximal end extending outside the proximal end of the barrel;

[0050] a secondary stopper disposed within the barrel interior, the secondary stopper having: a proximal axial end coupled to the distal end of the plunger, and a distal axial end defining a distal cavity therein;

[0051] a primary stop disposed within the barrel between the secondary stop and the distal end of the barrel, the primary stop having a proximal axial end defining a proximal cavity, a distal axial end defining a distal cavity having a seat surface, and a through passage defining fluid communication with both the proximal cavity and the distal cavity of the primary stop;

[0052] A telescoping actuator assembly, oriented with the respective cavities of the primary and secondary stops, having:

[0053] a plurality of nested tubes in sliding, frictional engagement with one another, each of the nested tubes having an outer peripheral surface and an inner wall; the outer peripheral surface of a most proximally oriented nested tube being coupled to the distal cavity of the secondary stop and within the distal cavity, wherein its inner wall is in sliding, frictional engagement with the outer peripheral surface of an adjacent tube captured therein, and

[0054] a reciprocating actuator oriented within the through passage of the primary stop, the actuator comprising: a collet bushing having an annular bushing edge, a radially projecting proximal axial face of the annular bushing edge being in opposite orientation to a matching, annular seat surface of the primary stop, a plurality of collet bushing fingers projecting away from the proximal axial face of the annular bushing edge, the plurality of collet bushing fingers being in frictional contact with a surface defining the through passage, a distal tip of each bushing finger projecting into the proximal cavity of the primary stop, a distal tip of each bushing finger being coupled to a platform oriented on a distal end of an actuator shaft, an outer surface of the proximal end of the actuator shaft being in sliding frictional engagement with the inner wall of a distally most oriented tube, the seat surface of the primary stop being captured between the collet bushing and the platform;

[0055] a primary fluid chamber within the barrel interior, the primary fluid chamber being defined between a distal end surface of the primary stopper and the outlet chamber at the distal end of the barrel, the volume of the primary fluid chamber being selectively variable by translation of the plunger; and

[0056] a secondary fluid chamber within the barrel interior, the secondary fluid chamber being defined between a distal end surface of the secondary stop and the through passage of the primary stop, the volume of the secondary fluid chamber being selectively variable by translation of the plunger when the proximal axial face of the annular bushing rim is spaced apart from the seat surface of the primary stop;

[0057] wherein the secondary fluid chamber is in fluid communication with the primary fluid chamber and the outlet chamber of the syringe when the proximal axial face of the annular sleeve edge is spaced apart from the seat surface of the primary stopper, and the secondary fluid chamber is isolated from the primary fluid chamber when the proximal axial face of the annular sleeve edge is in abutting contact with the seat surface of the primary stopper;

[0058] wherein withdrawing the plunger tensions the telescopic actuator assembly, reciprocating the proximal axial surface of the annular bushing edge into abutting contact with the seat surface of the main stopper, and withdrawing the stopper; and

[0059] wherein the advancement of the plunger under a first axial pressure alone advances the main stop, and the advancement of the plunger under an axial second pressure greater than the first axial pressure causes the proximal axial surface of the annular sleeve edge to reciprocate away from the abutting contact with the seat surface of the main stop, which establishes fluid communication between the secondary fluid chamber, the main fluid chamber and the outlet chamber and advances the secondary stop; and the advancement of the plunger under a third axial pressure greater than the second axial pressure causes the telescopic actuator assembly to collapse in the distal cavity of the corresponding secondary stop and the proximal cavity of the main stop.

[0060] In some embodiments, the present application relates to a method for manufacturing a syringe, comprising:

[0061] inserting the collet bushing fingers into the through passages of the primary stop such that they protrude into the proximal cavity of the primary stop;

[0062] rigidly coupling the platform of the actuator assembly to the tips of the collet bushing fingers, capturing the primary stop between the annular edge of the collet bushing and the cross-shaped platform;

[0063] before or after coupling the plunger to the second stopper, coupling the proximal-most oriented tube of the actuator assembly within the distal cavity of the second stopper; and

[0064] The now coupled primary stopper, actuator assembly, secondary stopper, and plunger are inserted into the interior of the syringe barrel.

[0065] In some embodiments, the syringe further comprises: a barrel ring formed on the inner wall of the barrel and protruding radially inward; and a path seal having an inner circumferential surface and an outer circumferential surface, wherein the inner circumferential surface limits the outer surface of the tube of the actuator assembly, the outer circumferential surface is in fluid-tight contact with the proximal cavity of the main stopper, and the path seal prevents fluid from flowing back from the main chamber to the secondary chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0067] Figure 1 is a cross-sectional view of an embodiment of a dual chamber syringe in which the secondary chamber is pre-filled with fluid and the primary, drug delivery chamber is collapsed;

[0068] Figure 2 yes Figure 1 an enlarged cross-sectional view of a distal portion of a syringe;

[0069] Figure 3 yes Figure 1 Exploded view of the syringe;

[0070] Figure 4 yes Figure 1 an axial end view of a drug stopper of a syringe;

[0071] Figure 5 yes Figure 1 A perspective view of a telescoping actuator assembly of a syringe in its fully extended configuration;

[0072] Figure 6 yes Figure 5 A cross-sectional view of a telescopic actuator assembly;

[0073] Figure 7 yes Figure 1 A perspective view of a telescoping actuator assembly of a syringe of in its fully collapsed configuration; Another embodiment of a dual chamber syringe, wherein each chamber contains a fluid;

[0074] Figure 8 Shows from Figure 1 Remove trapped air from the pre-filled chamber of the syringe;

[0075] Fig. 9 yes Figure 8 an enlarged cross-sectional view of a distal portion of a syringe;

[0076] Figures 10 to 13 are illustrative, sequential steps, showing the Figure 8aspiration of a drug from a drug chamber or primary chamber of a syringe, followed by dispensing / infusion of the drug, followed by actuation or opening of a fluid path of a pre-filled or secondary chamber, and finally delivery of a flushing fluid from the secondary chamber;

[0077] Fig.14 is a perspective view of an embodiment of a dual chamber, drug mixing syringe, wherein the secondary chamber is pre-filled with a diluent and the primary, drug delivery chamber is pre-filled with a powdered / lyophilized drug; and

[0078] Fig.15 yes Fig.14 Cross-sectional view of a syringe.

[0079] 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

[0080] Aspects of the dual chamber syringe embodiments disclosed herein facilitate selective drug mixing, dispensing and administration through a catheter or other vascular access device (VAD), as well as post-administration flushing of the catheter with a single syringe device. In general, in each disclosed embodiment, the syringe barrel includes an outlet, such as a Luer connector, a variable volume primary fluid chamber, and a secondary chamber pre-filled with a fluid such as a saline flush fluid. A plunger manipulated by a telescopic actuator assembly, which is coupled to a secondary or saline plunger stop, in conjunction with a primary or drug stop disposed within the barrel, serves as an isolation valve for selectively blocking or opening a through passage formed in the drug stop. The telescopic actuator assembly selectively isolates the secondary fluid chamber from fluid communication with the primary fluid chamber and / or the outlet of the syringe barrel only by retraction of the syringe plunger. The telescopic actuator assembly selectively opens the through passage only by advancement of the syringe plunger.

[0081] The isolated secondary chamber configuration advantageously facilitates the use of prepackaged medications or flushing solutions in the chamber, whereby the clinician is able to draw and dispense medication through the empty primary chamber and then immediately deliver the prepackaged flushing solution from the secondary chamber. In other embodiments, the syringes disclosed herein are used as drug mixing syringes, with a powdered medication prepackaged in the primary chamber and a diluent solution prepackaged in the secondary chamber. In some embodiments, a single advancement stroke on a single plunger of the syringe automatically delivers or injects the medication contained in the primary chamber into the VAD in sequence, followed by the flushing solution.

[0082] In the present disclosure, a convention is followed wherein the distal end of a device is the end closest to the patient, e.g., for delivering one or more medications to the patient, and the proximal end of the device is the end distal to the patient and closest to a clinician or other medical practitioner. With respect to the terms used in the present disclosure, the following definitions are provided.

[0083] As used herein, the use of “a,” “an,” and “the” includes both the singular and the plural.

[0084] As used herein, the term "Luer connector" refers to a connecting collar that is a standard method of attaching syringes, catheters, collared needles, IV tubing, etc. to one another. A Luer connector consists of male and female interlocking tubes that are slightly tapered to better hold together even with a simple press / twist fit. The Luer connector can optionally include an additional threaded outer edge to make it more secure. The male end of the Luer connector is associated with a flush syringe and can interlock and connect to the female end located on a vascular access device (VAD). The Luer connector also has a distal end channel and a proximal end channel, the distal end channel releasably attaching the Luer connector to the hub of the VAD and the proximal end channel releasably attaching the Luer connector to the barrel of the syringe.

[0085] As used herein, ISO 80369-7:2016 defines specifications for standard Luer connectors, including a 6% taper between the distal end and the proximal end. The male standard Luer connector increases from the open distal end to the proximal end. The female standard Luer connector decreases from the open proximal end to the distal end. According to ISO 80369-7:2016, the male standard Luer connector has an outer cross-sectional diameter of 0.75 mm measured between 3.970 mm and 4.072 mm from the distal end of the tip. The length of the male standard Luer taper is between 7.500 mm and 10.500 mm. The outer cross-sectional diameter of 0.75 mm is measured between 4.376 mm and 4.476 mm from the distal end of the tip. As used herein, the terms "male standard Luer connector" and "female standard Luer connector" shall refer to connectors having the dimensions described in ISO 80369-7, which is hereby incorporated by reference in its entirety.

[0086] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "tip", "hub", "thread", "protrusion / insertion", "tab", "inclined surface", "wall", "top", "side", "bottom" and others are used throughout the specification to facilitate understanding, they are not intended to limit any components that can be used in combination, or used alone, or require a specific spatial orientation to implement the various aspects of the embodiments of the present disclosure.

[0087] 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 process 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.

[0088] The matters illustrated in this specification are 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 clarity and brevity, descriptions of well-known functions and configurations are omitted.

[0089] In an exemplary embodiment of the present disclosure, the barrel of the syringe includes a distal end having a needleless connection. In one or more embodiments, the needleless connection includes at least one thread and other features in all combinations, thereby allowing it to engage with a corresponding thread or multiple threads of a corresponding connector.

[0090] According to other exemplary embodiments of the present disclosure, the configuration of the structural element constituting the needleless connector includes a collar protruding from the distal end of the barrel, the collar including at least one thread to connect to a corresponding thread or threads of a corresponding connector.

[0091] According to yet another exemplary implementation of an embodiment 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.

[0092] According to yet another exemplary embodiment of the present disclosure, the needleless connector may include internal threads and / or external threads, the internal threads being of a specific size and having a thread pattern to engage with a standard ISO 594-2 type male fitting, and the external threads being of a specific size and having a thread pattern to engage with a standard ISO 594-2 type female fitting. An example of an ISO 594-2 type fitting is a Q-type fitting.

[0093] In one or more embodiments, the female connector can be selected from the group consisting of a needle connector (for direct injection into a patient or insertion into a vial for drawing 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, Micro ClaveClear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, and the like.

[0094] In one or more embodiments, the male connector can be an IV line end or a stopcock.

[0095] Referring now to the drawings, a first aspect of the present disclosure is Figures 1 to 7 , wherein the syringe 20 includes a generally cylindrical barrel 22 defining an open proximal end 24, an inner sidewall 26, and a distal end 28. In other embodiments, the barrel 22 includes a non-cylindrical profile. The tapered distal end 28 of the barrel 22 includes a threaded Luer tip or connector 30 defining an outlet cavity 32 for attachment to and fluid communication with various associated VAD connectors (not shown). A threaded, selectively removable male Luer cap 34 seals the outlet cavity from ambient air. Reference Figure 1 , Figure 2 and Figure 4 , the main stopper or drug stopper 36 inserted in the syringe barrel 22 has a proximal axial end defining a proximal cavity 42 and a tapered distal axial end 42. The tapered profile of the distal axial end 42 matches the tapered profile of the distal end 28 of the syringe barrel 22 to facilitate complete evacuation of the fluid from the syringe. The proximal cavity 40 is in fluid communication with the fan-shaped through-passage 44 and the distal cavity 46 defined in the medical stopper 36. An axially oriented seat surface 47 is defined in the distal cavity 46, surrounding the fan-shaped through-passage 44.

[0096] refer to Figure 1 and Figure 3, the syringe 20 includes a secondary stopper or saline stopper 48 inserted within the barrel inner wall 26. The saline stopper 48 has a tapered profile distal end 50 that matches the tapered profile distal end of the proximal axial end 38 of the drug stopper 36. The saline stopper 48 defines a distal end cavity 52 having a radial groove 53. The proximal end 54 of the saline stopper 48 is coupled to the distal end 58 of the plunger 56. The proximal end 60 includes a finger pad.

[0097] refer to Figures 1 to 7 When the plunger is withdrawn, the telescoping actuator assembly 60 couples the drug stop 36, the saline stop 48 and the plunger 56 under tension. The actuator assembly 60 includes an actuator 64 having a collet bushing 66. The collet bushing 66 includes an annular bushing edge 68, the proximal side 70 of which is in an opposite orientation to the annular seat surface 47 of the distal cavity 46 of the drug stop 36. Figure 2 As shown, when the proximal side 70 of the annular edge 68 of the collet bushing 66 contacts and abuts the annular surface 47 of the medication stopper 36, it isolates the proximal cavity 40 of the medication stopper 36, and any fluid contained therein, from the outlet 32 ​​of the syringe 20 because the fluid cannot flow through the through passage 44 into the distal cavity 46.

[0098] refer to Figures 5 to 7 , the collet bushing 66 of the telescoping actuator assembly 62 has a plurality of bushing fingers 72 that respectively define a circumferential flange 74 that frictionally engages a cylindrical wall defining a proximal cavity 40 within the drug stop 36. A proximal axial tip 76 of each collet bushing finger 72 is coupled to and in abutting contact with a cross-shaped platform 80 of an actuator shaft 78. The actuator shaft defines a proximal spherical contoured end 82. The nested distal hollow tube 84, intermediate hollow tube 86, and proximal hollow tube 88 of the telescoping actuator assembly 62 couple the saline stop 48 to the actuator 64, as described below.

[0099] When viewed sequentially from the distal end 28 toward the proximal end 24 of the syringe barrel 22, the spherical profile end 82 of the actuator shaft 78 is retained within and in frictional contact with the inner wall surface 90 of the distal telescoping tube 84. The distal telescoping tube 84 defines a through hole 92 for passing fluid therethrough and a circumferential flange 94. The circumferential flange 94 of the telescoping distal tube 84 is retained within and in frictional contact with the inner wall surface 96 of the proximal tube 88. The proximal telescoping tube 88 defines a through hole 98 for passing fluid therethrough and a circumferential flange 100. The circumferential flange 100 of the telescoping intermediate tube 86 is retained within and in frictional contact with the inner wall surface 102 of the proximal tube 88. The proximal telescoping tube 88 defines a through hole 104 for passing fluid therethrough and a circumferential flange 106. The circumferential flange 106 of the telescoping proximal tube 88 is retained within the circumferential groove 53 formed within the distal cavity 52 of the saline stop 48. Figure 5 and Figure 6 ), whose axial length is sufficient to extend the actuator 64 away from contact with the corresponding seat surface 47 of the drug stop 36, thereby enabling selective fluid communication between the secondary chamber 108 and the syringe outlet 32. In order to prevent the telescoping tubes 82, 84, 86 from collapsing during advancement of the syringe plunger 56, during drug delivery, or during air aspiration from the main / drug chamber 110, the friction force generated within the telescoping actuator assembly 62 between any pair of contacting spherical profile ends 82, circumferential flanges 94, 100 and their corresponding inner wall surfaces 90, 96, 102 is greater than the combined friction force generated between the drug stop 36 and the barrel inner wall 22 and the axial force required to advance the collet bushing 66 to the distal side of the seat surface 47 of the drug stop 36. When the external axial force exerted on the advancing plunger 56 exceeds the above combined friction force generated within the telescoping actuator assembly 62, it causes the assembly to collapse.

[0100] When the plunger is fully advanced within the syringe barrel 22, the telescoping distal tube 84, the intermediate tube 86 and the actuator shaft 78 collapse within the proximal telescoping tube 88, as shown in FIG. Fig.13 The collapsed, nested tubes 82, 84, 88, actuator shaft 78, and cruciform platform 80 have an axial length that is less than the combined distal lumen of saline stop 48 and proximal lumen 40 of drug stop 36 such that secondary chamber 108 is fully collapsed.

[0101] While the syringe 20 embodiment includes three nested telescoping tubes 84, 86, and 88 that mate with the actuator shaft 78 of the actuator 64, other syringe embodiments also have a single tube that mates with the actuator shaft. Other syringe embodiments have two nested tubes that mate with the actuator shaft. Still other syringe embodiments include more than three nested telescoping tubes.

[0102] like Figure 1 and Fig.10 As shown, the syringe 20 is a dual chamber syringe having a secondary chamber 108 and a primary chamber 110 that are in series, axially aligned and oriented, and have variable volumes. The primary chamber 110 is circumferentially defined within the barrel inner wall 26 and axially defined by the distal face 42 of the drug stop 36 and the distal axial end 28 of the barrel 22. The secondary chamber 108 is circumferentially defined within the barrel inner wall 26 and axially defined by the distal face 50 of the saline stop 48 and the proximal-distal axial end 38 of the drug stop 36. The telescoping actuator assembly 62 serves as a manually actuated, selectively isolating valve that facilitates the discharge of fluid from the secondary chamber 108. The plunger clamp 112, which is also referred to as a plunger collar, prevents inadvertent advancement of the plunger 56 and is removed by the healthcare practitioner prior to use of the syringe 20 (see, e.g., Figure 1 , Figure 8 , Fig.14 as well as Fig.15 ). In one or more embodiments, the variable volume main chamber 110 is pre-filled with a desired drug or is filled with a desired drug at a patient treatment site. In one or more embodiments, the variable volume secondary chamber 108 is pre-filled with a desired amount of saline or other flushing or diluting fluid. In one or more embodiments, during or after assembly of the syringe 20, the main chamber 108 is pre-filled with a liquid or powdered / lyophilized drug and the secondary chamber 110 is pre-filled with saline, other flushing fluid, or other drug diluent using a sterile filling method. In some embodiments, the barrel 22 of the syringe 20 includes measurement markings (not shown) to indicate the amount of fluid contained therein.

[0103] Figure 1 , Figure 2 , Figures 8 to 14 The functional operation of an embodiment of the syringe 20 is depicted wherein its secondary chamber 108 is pre-filled with a flushing fluid, such as saline, and packaged for transport to and use by a medical facility. Figure 1 The syringe 20 is depicted in its shipping state after the outer packaging has been removed but before the male Luer cap 34 has been removed. The plunger clip / plunger collar 112 surrounds the plunger 56 between the proximal end 60 of the plunger 56 and the proximal end 24 of the syringe barrel 22 to prevent inadvertent advancement of the plunger. During shipping, the distal end 42 of the drug stopper 36 is in abutting contact with the distal end 28 of the syringe barrel 22, causing the primary chamber 108 to be completely collapsed and emptied. The telescoping actuator assembly 62 aligns the secondary chamber with the outlet 32 ​​( Figure 2 ) isolation to prevent saline from leaking out of the syringe. The plunger clip / plunger collar 112 and the male Luer cap 34 are removed from the syringe 20 before use.

[0104] Figure 8and Fig. 9 It is depicted that air trapped within the pre-filled secondary chamber 108 of the prepackaged syringe 20 is removed by advancing the plunger 56 (arrow A) sufficiently to disengage the proximal side 70 of the hub edge 68 of the actuator 64 from contact with the seat surface 47 of the drug stopper 36. In this partially advanced state of the plunger 56, the separation of the actuator 64 from the seat surface 47 allows fluid communication between the secondary chamber 108, the proximal cavity 40, the fluid through-passage 44, and the outlet 32 ​​of the Luer tip 30, thereby allowing the trapped air to escape from the secondary chamber 108.

[0105] Fig.10 Depicted is the drawing of medicament into the primary chamber 110 by withdrawing or retracting the plunger 56 (arrow R). The retraction of the plunger 56 tensions the telescoping actuator assembly 62, which seats the proximal surface 70 of the collet bushing edge 68 against the corresponding seating surface 47 of the medicament stopper 36. The retraction of the plunger 56 also creates a negative pressure differential in the primary chamber 110 relative to the ambient pressure in the outlet 32; this helps maintain contact between the proximal surface 70 and the seating surface 47 (i.e., re-isolating the secondary chamber 108 by closing the valve) while drawing medicament from a vial (not shown) into the primary chamber.

[0106] Fig.11 The delivery of medication to a patient's VAD (not shown) is shown. Medication is infused from the main chamber 110 into the previously flushed VAD by advancing the plunger 56 (arrow A), thereby emptying the main chamber. The advancing pressure applied to the plunger 56 is sufficient to advance the medication stopper 36 into contact with the distal end 28 of the syringe barrel 22, but is insufficient to advance the actuator 64 out of contact with the seat surface 47 of the medication stopper.

[0107] exist Fig.12 and Fig.13 In the embodiment of the present invention, the plunger 56 is pushed with sufficient pressure to push the actuator 64 into contact with the seat surface 47 ( Fig.12 ) is disengaged and the VAD is flushed with a flushing solution (e.g., saline or heparin) prepackaged in the secondary chamber 108. This opens the valve and delivers the flushing solution out of the outlet 32 ​​( Fig.13 ), until the secondary chamber 108 collapses and is emptied. After the flushing process is completed, the syringe 20 is then withdrawn from the VAD.

[0108] Another aspect of the present disclosure is Fig.14 and Fig.151, wherein a dual chamber syringe 120 (having a similar construction to syringe 20) facilitates mixing a pre-filled powder / lyophilized drug in a primary chamber 110 with a pre-filled diluent (e.g., saline) in a secondary chamber 108. A radially inwardly projecting barrel ring 130 formed on the inner wall 126 of the syringe barrel 122 prevents the drug stopper 36 from being advanced distally beyond the ring. The advancement pressure on the plunger 56 required to overcome the advancement resistance of the barrel ring 130 is higher than the advancement pressure required to advance the telescoping actuator assembly 62 beyond engagement with the drug stopper 36 and allow saline to flow from the secondary chamber 108 into the primary / mixing chamber 110. After the plunger clip / collar 112 is removed from the plunger 56 and the plunger is subsequently advanced toward the barrel ring 130, the telescoping actuator assembly 62 opens the drug stopper fluid passage 44, thereby allowing saline or other diluent to mix with the drug. After shaking or otherwise agitating the drug / diluent mixture, the male Luer cap 34 is removed from the syringe 120 and the syringe plunger 56 is advanced sufficiently to remove trapped air from the primary chamber 108. The now mixed drug 120 is delivered after the Luer connector 30 is attached to the VAD. A pathway seal 132 surrounds the telescoping actuator assembly to prevent the diluent / drug mixture from flowing back or refluxing from the primary chamber 110 to the secondary chamber 110 via the drug stopper fluid passage 44. The outer circumference 134 of the pathway seal 132 abuts against or within the proximal cavity 40 in the drug stopper 36, while its inner circumference 136 abuts against the respective outer circumferential surfaces of the intermediate telescoping tube 86 and the proximal telescoping tube 88.

[0109] Although separate and alternative syringe embodiments 20 and 120 are shown and described herein, any embodiment can be used to: (a) sequentially administer different pre-filled medications in both their respective primary chambers 110 and secondary chambers 108, or (b) draw / administer medication in their respective primary chambers and then administer another medication from their respective secondary chambers, or (c) draw / administer medication in their respective primary chambers and then flush the VAD with a pre-filled flush fluid in their respective secondary chambers, or (d) administer pre-filled medications in their respective primary chambers and then flush the VAD with a pre-filled flush fluid in their respective secondary chambers, or (e) mix pre-filled powdered / lyophilized medications in their respective primary chambers and then flush the VAD with a pre-filled flush fluid in their respective secondary chambers.

[0110] Through a single, continuous stroke of the syringe plunger 56, a single syringe 20 facilitates sequential delivery of pre-filled or field-drawn drugs to a patient's VAD within its main chamber 110, and then immediately flushes the VAD with pre-filled saline or other flushing fluids contained within its main chamber. The syringe 20 does not require the manipulation of multiple plungers, non-linear or compound plunger movements, or external valves to sequentially deliver drugs and flushing fluids. A single syringe 20 performs both drug delivery and flushing processes that are usually performed with a separate syringe. As previously described, by simplifying drug delivery and flushing with a single syringe 20, the costs associated with purchasing multiple syringes are reduced. In some embodiments, a single syringe 20 reduces the risk of patient drug delivery errors because the drug and / or flushing solution are already pre-filled in the syringe. In some embodiments, a single syringe 20 reduces the risk of a patient's VAD not being flushed after administering a drug due to a distracted medical professional because the flushing solution has been pre-filled in the secondary chamber 108. Simply put, a professional is more likely to complete the advancement of a single plunger 56 stroke with a syringe 20 that is delivered sequentially after she or he completes drug administration, without the need to replace the drug syringe with a new and separate flushing syringe. Sequential drug administration and VAD flushing with a single syringe 20 also reduces the risk of infection caused by multiple punctures of the VAD's septum by separate syringes. Finally, the syringe 20 utilizing its telescoping actuator assembly 64 does not need to puncture the drug stopper 36 to expel flushing solution from its secondary chamber 108; this reduces the possibility of a damaged stopper particulate matter infiltrating the VAD or the patient.

[0111] The syringe 120 facilitates mixing of a powdered / lyophilized drug pre-filled in the primary chamber 110 with a diluent (e.g., saline) pre-filled in the secondary chamber, and subsequently delivering the mixed drug via a single, continuous stroke of the syringe plunger 56. The syringe 120 does not require manipulation of multiple plungers, non-linear or compound plunger motions, or external valves to sequentially mix and administer medications. In some embodiments, a single syringe 120 reduces the risk of medication delivery errors to a patient because the medication and diluent are already pre-filled in the syringe. Finally, the syringe 120, utilizing its telescoping actuator assembly 64, does not require piercing of a medication stopper 36 to expel diluent from its secondary chamber 108 into the primary chamber 110; this reduces the likelihood of a damaged stopper and particulate matter infiltration into the VAD or the patient.

[0112] The syringe embodiments disclosed herein are made of medical grade materials known to those skilled in the art. In some embodiments, the barrel, plunger and shaft described are made of polypropylene polymer. The seal is made of fiber-filled polytetrafluoroethylene (PTFE) polymer. The stopper is made of polyisoprene polymer.

[0113] A method for manufacturing a syringe is disclosed herein, the method comprising: inserting the collet bushing fingers into the through passages of the primary stop so that they protrude into the proximal cavity of the primary stop; rigidly coupling the platforms of the actuator assembly to the tips of the collet bushing fingers, thereby capturing the primary stop between the annular edge of the collet bushing and the cross-shaped platform; coupling the proximal-most-directed tube of the actuator assembly within the distal cavity of the secondary stop either before or after coupling the plunger to the secondary stop; and inserting the now coupled primary stop, actuator assembly, secondary stop, and plunger into the interior of the syringe barrel.

[0114] 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 various places throughout the 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 may 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. "Including", "including" or "having" and their variations used herein are intended to cover the items listed below and its equivalents and other 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, "connected" and "coupled" are not limited to physical, mechanical or electrical connections or couplings.

[0115] Although the disclosure herein provides a description with reference to embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations 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 exemplary embodiment details of the construction and arrangement of the components set forth in the specification or illustrated in the drawings.

Claims

1. A sequential drug delivery syringe, characterized in that: The sequential drug delivery syringe comprises: a hollow syringe barrel defining an inner wall, a proximal barrel end, and a distal barrel end, the distal end of the barrel including a connector defining an outlet chamber therethrough, the outlet chamber being in fluid communication with an interior of the barrel defined by the open proximal end, the distal end, and the inner wall; a plunger disposed with the barrel interior, the plunger having a proximal end extending outside the proximal end of the barrel, and a distal end; a secondary stopper disposed within the barrel interior, the secondary stopper having: a proximal axial end coupled to the distal end of the plunger, and a distal axial end defining a distal cavity therein; a primary stop disposed within the barrel between the secondary stop and the distal end of the barrel, the primary stop having a proximal axial end defining a proximal cavity, a distal axial end defining a distal cavity having a seat surface, and a through passage defining fluid communication with both the proximal cavity and the distal cavity of the primary stop; a telescoping actuator assembly oriented with the respective cavities of the primary and secondary stops, the telescoping actuator assembly having: a reciprocating actuator oriented within the through passage of the primary stop, the actuator projecting into the proximal cavity and the distal cavity of the stop and having: an outer peripheral surface that engages the through passage in a sliding, frictional manner; and a radially projecting proximal axial face oriented within a corresponding distal cavity of the primary stop opposite to the orientation of the seat surface, and a tube having an outer peripheral surface coupled to and within the distal cavity of the secondary stop and an inner wall constraining and slidingly, frictionally engaging the outer peripheral surface of the actuator; a primary fluid chamber within the barrel interior, the primary fluid chamber being defined between the distal end surface of the primary stopper and the outlet chamber at the distal end of the barrel, the volume of the primary fluid chamber being selectively variable by translation of the plunger; and a secondary fluid chamber within the barrel interior, the secondary fluid chamber being defined between a distal end surface of the secondary stop and the through passage of the primary stop, the volume of the secondary fluid chamber being selectively variable by translation of the plunger when the proximal axial face of the actuator is spaced apart from the seat surface of the primary stop; wherein the secondary fluid chamber is in fluid communication with the primary fluid chamber and the outlet chamber of the syringe when the proximal axial face of the actuator is spaced apart from the seat surface of the primary stopper, and the secondary fluid chamber is isolated from the primary fluid chamber when the proximal axial face of the actuator is in abutting contact with the seat surface of the primary stopper; wherein withdrawing the plunger tensions the telescopic actuator assembly, reciprocates the proximal axial surface of the actuator into abutting contact with a seat surface of the main stop, and withdraws the stop; and Wherein, the plunger alone pushes the main stopper, causing the proximal axial surface of the actuator to reciprocate and disengage from the abutment contact with the seat surface of the main stopper, pushing the secondary stopper, and causing the telescopic actuator assembly to collapse within the corresponding distal cavity of the secondary stopper and the proximal cavity of the main stopper.

2. The syringe according to claim 1, characterized in that The actuator assembly also includes a plurality of nested tubes that are slidably and frictionally engaged with each other, each of the nested tubes having an outer peripheral surface and an inner wall; The outer peripheral surface of a most distally oriented nested tube is coupled to and within the distal cavity of the secondary stop, wherein its inner wall is slidingly, frictionally engaged with the outer peripheral surface of an adjacent tube captured therein; and the inner wall of a most distally oriented nested tube constrains and is slidingly, frictionally engaged with the outer peripheral surface of the actuator.

3. The syringe according to claim 2, characterized in that The actuator also includes a collet bushing having an annular bushing edge, the radially projecting proximal axial face of the annular bushing edge being in opposite orientation to the seat surface of the primary stop; a plurality of collet bushing fingers projecting away from the proximal axial face of the annular bushing edge, the plurality of collet bushing fingers being in frictional contact with a surface defining the through passage, the distal tip of each bushing finger projecting into the proximal cavity of the primary stop.

4. The syringe according to claim 3, characterized in that The actuator further includes: the distal tip of the collet bushing finger coupled to a platform of the distal end of the actuator shaft; the outer surface of the proximal end of the actuator shaft slidingly frictionally engaging the inner wall of the distal-most directed tube, the seat surface of the primary stop being captured between the collet bushing and the platform.

5. The syringe according to claim 4, characterized in that At least one of the collet bushing fingers defines a circumferential flange projecting radially outwardly, the circumferential flange being in frictional contact with a surface defining the through passage.

6. The syringe according to claim 5, characterized in that The collet bushing includes four evenly circumferentially spaced collet fingers rigidly coupled to corresponding cross-shaped platforms of the actuator, the proximal outer surface of the actuator shaft defining a spherical surface profile for frictionally engaging a corresponding inner wall surface of the distal-most directed tube.

7. The syringe according to claim 6, characterized in that The syringe also includes three nested tubes, the most proximal-oriented nested tube defining a peripheral flange at its distal end, the peripheral flange matingly engaging with a corresponding circumferential groove defined in the distal cavity of the secondary stop, and the inner wall surface of the most distal-oriented nested tube being in frictional engagement with the spherical surface of the actuator shaft.

8. The syringe according to claim 1, characterized in that The actuator also includes a collet bushing having an annular bushing edge, the radially projecting proximal axial face of the annular bushing edge being in opposite orientation to the seat surface of the primary stop; a plurality of collet bushing fingers projecting away from the proximal axial face of the annular bushing edge, the plurality of collet bushing fingers being in frictional contact with a surface defining the through passage, the distal tip of each bushing finger projecting into the proximal cavity of the primary stop.

9. The syringe according to claim 8, characterized in that The actuator further includes: the distal tip of the collet bushing finger coupled to a platform of the distal end of the actuator shaft; an outer surface of the proximal end of the actuator shaft slidingly frictionally engaged with the inner wall of the tube, the seat surface of the primary stop being captured between the collet bushing and the platform.

10. The syringe according to claim 9, characterized in that At least one of the collet bushing fingers defines a circumferential flange projecting radially outwardly, the circumferential flange being in frictional contact with a surface defining the through passage.

11. The syringe according to claim 10, characterized in that The collet bushing includes four evenly circumferentially spaced collet fingers rigidly coupled to corresponding cross-shaped platforms of the actuator, the proximal outer surface of the actuator shaft defining a spherical surface profile for frictionally engaging a corresponding inner wall surface of the tube.

12. The syringe according to claim 1, characterized in that The syringe also includes: a barrel ring formed on the inner wall of the barrel and protruding radially inward; and a path seal having an inner circumferential surface and an outer circumferential surface, wherein the inner circumferential surface limits the outer surface of the tube of the actuator assembly, the outer circumferential surface is in fluid-tight contact with the proximal cavity of the main stopper, and the path seal prevents fluid from flowing back from the main fluid chamber to the secondary fluid chamber.

13. The syringe according to claim 12, characterized in that The syringe is sterile and prepackaged, wherein the syringe further comprises a dry or powdered drug in the primary fluid chamber, and a drug diluent in the secondary fluid chamber thereof.

14. The syringe according to claim 1, characterized in that The distal end of the main stop and the distal end of the syringe barrel have corresponding, matching profiles that contact each other when the main stop is fully inserted into the interior of the syringe barrel, thereby minimizing the volume of the primary fluid chamber.

15. The syringe according to claim 1, characterized in that The proximal end of the primary stop and the distal end of the secondary stop have corresponding, matching profiles that contact each other when the secondary stop is fully inserted into the interior of the syringe barrel, thereby minimizing the volume of the secondary fluid chamber.

16. The syringe according to claim 1, characterized in that The syringe is sterile and prepackaged, wherein the syringe also includes a flushing fluid in its secondary fluid chamber.

17. The syringe according to claim 1, characterized in that in: The advancement of the plunger under a first axial pressure advances the main stop, and the advancement of the plunger under a second axial pressure greater than the first axial pressure causes the proximal axial surface of the actuator to reciprocate away from the abutting contact with the seat surface of the main stop, which establishes fluid communication between the secondary fluid chamber, the main fluid chamber and the outlet chamber and advances the secondary stop.

18. A sequential drug delivery syringe, characterized in that: The sequential drug delivery syringe comprises: a hollow syringe barrel defining an inner wall, a proximal barrel end, and a distal barrel end, the distal end of the barrel including a connector defining an outlet chamber therethrough, the outlet chamber being in fluid communication with an interior of the barrel defined by the open proximal end, the distal end, and the inner wall; a plunger disposed with the barrel interior, the plunger having a distal end and a proximal end extending outside the proximal end of the barrel; a secondary stopper disposed within the barrel interior, the secondary stopper having: a proximal axial end coupled to the distal end of the plunger, and a distal axial end defining a distal cavity therein; a primary stop disposed within the barrel between the secondary stop and the distal end of the barrel, the primary stop having a proximal axial end defining a proximal cavity, a distal axial end defining a distal cavity having a seat surface, and a through passage defining fluid communication with both the proximal cavity and the distal cavity of the primary stop; A telescoping actuator assembly, oriented with the respective cavities of the primary and secondary stops, having: a plurality of nested tubes in sliding, frictional engagement with one another, each of the nested tubes having an outer peripheral surface and an inner wall; the outer peripheral surface of a most proximally oriented one of the nested tubes being coupled to and within the distal cavity of the secondary stopper, wherein its inner wall is in sliding, frictional engagement with the outer peripheral surface of an adjacent tube captured therein, and a reciprocating actuator oriented within the through passage of the primary stop, the actuator comprising: a collet bushing having an annular bushing edge, a radially projecting proximal axial face of the annular bushing edge being in opposite orientation to a matching, annular seat surface of the primary stop, a plurality of collet bushing fingers projecting away from the proximal axial face of the annular bushing edge, the plurality of collet bushing fingers being in frictional contact with a surface defining the through passage, a distal tip of each bushing finger projecting into the proximal cavity of the primary stop, a distal tip of each bushing finger being coupled to a platform oriented on a distal end of an actuator shaft, an outer surface of the proximal end of the actuator shaft being in sliding frictional engagement with the inner wall of a distally most oriented tube, the seat surface of the primary stop being captured between the collet bushing and the platform; a primary fluid chamber within the barrel interior, the primary fluid chamber being defined between a distal end surface of the primary stopper and the outlet chamber at the distal end of the barrel, the volume of the primary fluid chamber being selectively variable by translation of the plunger; and a secondary fluid chamber within the barrel interior, the secondary fluid chamber being defined between a distal end surface of the secondary stop and the through passage of the primary stop, the volume of the secondary fluid chamber being selectively variable by translation of the plunger when the proximal axial face of the annular bushing rim is spaced apart from the seat surface of the primary stop; wherein the secondary fluid chamber is in fluid communication with the primary fluid chamber and the outlet chamber of the syringe when the proximal axial face of the annular sleeve edge is spaced apart from the seat surface of the primary stopper, and the secondary fluid chamber is isolated from the primary fluid chamber when the proximal axial face of the annular sleeve edge is in abutting contact with the seat surface of the primary stopper; wherein withdrawing the plunger tensions the telescopic actuator assembly, reciprocating the proximal axial surface of the annular bushing edge into abutting contact with the seat surface of the main stopper, and withdrawing the stopper; and wherein the advancement of the plunger under a first axial pressure alone advances the main stop, and the advancement of the plunger under a second axial pressure greater than the first axial pressure causes the proximal axial surface of the annular sleeve edge to reciprocate away from the abutting contact with the seat surface of the main stop, which establishes fluid communication between the secondary fluid chamber, the main fluid chamber and the outlet chamber and advances the secondary stop; and the advancement of the plunger under a third axial pressure greater than the second axial pressure causes the telescopic actuator assembly to collapse in the distal cavity of the corresponding secondary stop and the proximal cavity of the main stop.

19. The syringe according to claim 18, characterized in that The syringe also includes: a barrel ring formed on the inner wall of the barrel and protruding radially inward; and a path seal having an inner circumferential surface and an outer circumferential surface, wherein the inner circumferential surface limits the outer surface of the tube of the actuator assembly, the outer circumferential surface is in fluid-tight contact with the proximal cavity of the main stopper, and the path seal prevents fluid from flowing back from the main fluid chamber to the secondary fluid chamber.

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