Flush syringe assembly and method for disinfecting a vascular access device - Patents.com

Abstract

A syringe assembly is described that includes an absorbent pad containing a disinfectant and a rotatable cap to ensure adherence to aseptic technique for use in vascular access device (VAD) flushing procedures. Also described is a method for disinfecting a vascular access device.

Description

[Technical field]

[0001] The present invention relates to a syringe with a disinfecting function, and more particularly to a syringe assembly including a disinfecting cap for use in flushing procedures for vascular access devices (VAD's). [Background technology]

[0002] Vascular access devices (VAD's) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VAD's: peripheral catheters and central venous catheters. To ensure that VAD's are used and maintained correctly, standards of practice have been developed that include cleaning procedures commonly referred to as catheter flushing.

[0003] VAD protocols (standards of practice) usually recommend performing flush procedures after catheter placement, before fluid infusion, drug administration, blood withdrawal, transfusion, and parenteral nutrition. The purpose of these flush procedures is to confirm catheter patency, avoid drug incompatibility, ensure complete drug administration, prevent clot formation, and minimize the risk of bloodstream infection. Flush procedures require different types and amounts of flush solutions. The most commonly used flush solutions are saline and / or heparin lock solution. The type and amount of flush solution varies depending on the specific type of catheter. A flush solution volume of 5-10 ml is most common, but may range from 1 ml to 20 ml.

[0004] For flush procedures, the IV line refers to a system that may include the VAD, a tubing set with clamps, and a VAD connector as a termination. A common type of VAD connector is covered with a pierceable septum or pre-slit septum made of rubber or another elastomeric material, which allows a sharp needle cannula to be inserted to inject or withdraw fluids from the catheter. When the needle cannula is withdrawn, the septum seals itself. Ports with pre-slit septa are used with a blunt plastic cannula or the frusto-conically shaped tip of a syringe barrel. The tip of the syringe or a blunt plastic cannula (usually attached to a syringe) is gently pushed into the pre-slit septum to establish fluid communication.

[0005] IV valves, another type of VAD connector that does not require a sharp-tipped needle, are actuated by the frusto-conical tip of the syringe barrel and allow fluid communication between the interior of the syringe and the catheter. These valves may include features for delivering fluid from a storage compartment within the valve to the catheter and are referred to in the art as positive displacement valves. An example of such a valve is disclosed in U.S. Patent No. 6,206,861.

[0006] Bacteria and other microorganisms may enter the patient's vascular system through the access hub and ports / valves upon connection to a VAD for delivery of fluids or medications. Each access hub (or access port / valve or connection) carries some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. Contamination can occur during mixing of drugs, attachment of the cannula, and insertion into the access hub. Currently, risk to the hospital and patient is essentially a function of the diligence of the clinician making the connection, and this diligence is largely uncontrollable.

[0007] A currently available product aimed at combating the problems associated with contaminated VAD connectors is the SwabCap®. This device disinfects the VAD connector by covering it and protecting it from touch and airborne contamination after the cap is installed. When the SwabCap® is screwed onto the VAD connector, a foam pad within the cap compresses and releases isopropyl alcohol, which passively disinfects the top and threads of the VAD connector while the cap is in place. Because the SwabCap® is a separate component, there is room for error and the cap may not be available after all steps of the flushing process. Thus, the cap does not ensure compliance with sterile technique.

[0008] Therefore, there is a need for a flush syringe assembly that facilitates compliance with aseptic technique by eliminating additional wiping and disinfecting steps. Summary of the Invention

[0009] An embodiment of the present disclosure relates to a syringe assembly for use in flush applications and methods of disinfecting syringes. A syringe assembly, for example a flush syringe assembly according to a first embodiment of the present disclosure, includes a barrel including a sidewall having an outer surface, an inner surface defining a chamber for holding a fluid, an open proximal end, and a distal end including a distal wall from which extends a distal tip having a first passageway therethrough in fluid communication with the chamber, a removable seal disposed on the peripheral distal surface, and a cap and absorbent pad containing a disinfectant disposed between the removable seal and the distal tip, the cap being rotatable from a first position in which the distal tip is covered by the cap and a second position in which the distal tip of the barrel is exposed through the open distal end of the outer sleeve. In some embodiments, the assembly further includes an outer sleeve in slidable engagement with an exterior surface of the barrel, the outer sleeve including an open distal end having an interior surface, an exterior surface, and a peripheral distal surface, and relative sliding motion of the outer sleeve and the barrel brings a distal tip of the barrel and a distal end of the outer sleeve toward one another such that the distal tip rotates the cap from the first position to the second position.

[0010] As a second embodiment, a syringe assembly, e.g., a flush syringe assembly, includes a barrel including a sidewall having an exterior surface, an interior surface defining a chamber for holding a fluid, an open proximal end, and a distal end, a distal tip extending distally therefrom and including a distal wall having a first passageway in fluid communication with the chamber, and a cap covering the distal tip, the cap including a proximal side covering the distal dip and a distal side including an absorbent pad mounted thereon, the cap pivotally movable from a first position where the cap covers the distal tip to a second position where the cap is moved in a direction away from the distal tip.

[0011] A second aspect of the present disclosure relates to a method of disinfecting a vascular access device, the method according to one embodiment including exposing an absorbent pad containing a disinfectant at a distal end of a flush syringe assembly including a barrel having a distal tip covered by a cap, contacting the vascular access device with the absorbent pad, and then rotating the cap to expose the distal tip of the barrel. [Brief description of the drawings]

[0012] [Figure 1] FIG. 1 is an exploded perspective view of a flush syringe assembly according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of a flush syringe assembly according to one embodiment of the present disclosure. [Diagram 3] 3 is an enlarged, partially cross-sectional side view of the flush syringe assembly of FIG. 2. FIG. [Figure 4] 4 is a partial perspective view of a distal portion of the flush syringe assembly of FIG. 2. FIG. [Diagram 5] FIG. 5 is a perspective view of the flush syringe of FIG. 2 with a cap extended from the distal end of the flush syringe. [Figure 6] 6 is an enlarged, partial cross-sectional side view of the flush syringe of FIG. 2 with a cap extended from the distal end of the flush syringe. [Figure 7] FIG. 7 is a partial perspective view of the flush syringe of FIG. 2 with a cap extended from the distal end of the flush syringe. [Figure 8A] 8A is a perspective view of the distal side of the cap of the flush syringe of FIG. 2. FIG. [Figure 8B] The perspective view of FIG. 8B shows the proximal side of the cap of the flush syringe of FIG. [Figure 9] 9 is a perspective view of an alignment collar of the flush syringe of FIG. 2. FIG. [Figure 10] FIG. 10 is an exploded perspective view of a flush syringe assembly according to a second embodiment of the present disclosure. [Figure 11] FIG. 11 is a perspective view of a flush syringe assembly according to a second embodiment of the present disclosure. [Figure 12] 12 is an enlarged, partial cross-sectional side view of the flush syringe assembly of FIG. 11 with the cap in the retracted position. [Figure 13] 13 is an enlarged, partial cross-sectional side view of the flush syringe assembly of FIG. 11, showing the cap moving from the retracted position to the extended position. [Figure 14] 14 is an enlarged, partial cross-sectional side view of the flush syringe of FIG. 11 with a cap extended from the distal end of the flush syringe. [Figure 15] FIG. 15 is a partial perspective view of the distal end of the flush syringe assembly with the cap in the extended position. [Figure 16A] 16A is a perspective view of the distal side of the cap of the flush syringe assembly of FIG. 11. FIG. [Figure 16B] 16B is a perspective view of the proximal side of the cap of the flush syringe assembly of FIG. [Figure 17] 17 is a perspective view of an alignment collar of the flush syringe assembly of FIG. 11. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] Before describing certain example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description as being capable of other embodiments and of being practiced or carried out in various ways.

[0014] The following definitions are provided for terms used in this disclosure.

[0015] References to a "flush syringe assembly" include syringes indicated for use in flushing a VAD, which ensures and maintains catheter patency and prevents mixing of incompatible medications.

[0016] As used herein, the use of "a," "an," and "the" includes the singular and plural. As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or IV line. As used herein, the term "microorganism" refers to a microorganism or organism that is single-celled or lives in a colony of cellular organisms. Microorganisms are highly diverse and include, but are not limited to, bacteria, fungi, archaea, and protozoa. Microorganisms are often the cause of CRBSI. The most common microorganisms associated with CRBSI include, but are not limited to, Staphylococcus aureus and epidermidis, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans.

[0017] As used herein, the term "antimicrobial agent" or "antimicrobial" refers to a substance that kills or inhibits the growth of microorganisms, such as bacteria, fungi, archaea, or protozoa. An antimicrobial agent kills or prevents the growth of microorganisms. As used herein, the term "antiseptic" refers to an antimicrobial substance used on a non-living body or outside the body, for example, on the skin. In one or more embodiments, the antiseptic or antimicrobial agent may be ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chlorooxylenol, chlorhexidine, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, and mixtures thereof.

[0018] As used herein, the terms "absorbent material" and "absorbent pad" refer to a material that has the ability or tendency to absorb or absorb another substance. In one or more embodiments, the absorbent material has a tendency to absorb a disinfectant or antibacterial agent. Absorbent materials and absorbent pads may include sponges, absorbent cotton, foams, other absorbent fabrics, and synthetic polymer matrices.

[0019] As used herein, the term "Luer connector" refers to a connecting collar that is a standard method of attaching syringes, catheters, hubbed needles, IV tubing, and the like to one another. Luer connectors consist of male and female interlocking tubes that are slightly tapered to allow a secure connection, even with a simple press / twist fit. Luer connectors can optionally include a threaded outer rim to make it more secure. The male end of the Luer connector is typically associated with a flush syringe and can be mated to a female end on a VAD. The Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, and a profiled central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. The Luer connector also has a distal end channel that removably attaches the Luer connector to the hub of the VAD, and a proximal end channel that removably attaches the Luer connector to the barrel of the syringe.

[0020] According to one or more embodiments, a syringe assembly is provided that includes an absorbent material or pad containing a disinfectant or antimicrobial material that moves away from the distal end of the syringe to expose the distal tip of the syringe. In one or more embodiments, the absorbent material is positioned to minimize obstruction to the distal tip of the syringe, which allows the distal tip of the syringe to access ports that are typically difficult to access, such as a Y-connector. According to one or more embodiments, activating the device to expose the disinfectant is accomplished by squeezing two parts of the syringe assembly together. This allows a user of the assembly to activate the device with one hand, thus preventing interruptions in workflow.

[0021] 1-9, a first embodiment of a flush syringe assembly 100 is shown. The flush syringe assembly 100 includes a barrel 102 including a sidewall 104 having an exterior surface 106, with an interior surface 108 defining a chamber 110 for holding a fluid. The barrel 102 further includes an open proximal end 112 and a distal end 114 including a distal wall 116 having a distal tip 118 having a first passageway 120 in fluid communication with the chamber 110.

[0022] 1-11 further includes an outer sleeve 132 slidably engaging the exterior surface 106 of the barrel 102, the outer sleeve 132 including an inner surface 134, an outer surface 136, and an open distal end 138 including a periphery of a distal surface 140. The syringe assembly 100 further includes a removable seal 150 disposed on the peripheral distal surface 140. The device further includes a cap 152 and an absorbent pad 154 including an antiseptic disposed between the removable seal 150 and the distal tip, the cap 152 being rotatable from a first position in which the distal tip 118 of the barrel 102 is covered by the cap 152 and a second position in which the distal tip 118 of the barrel 102 is exposed through the open distal end 138 of the outer sleeve 132.

[0023] 2-4 show the flush syringe assembly 100 in a first position with the distal tip 118 of the barrel 102 covered by the cap 152. In this embodiment, the cap 152 includes a proximal side 151 and a distal side 153. In the first position, the proximal side 151 of the cap 152 covers the distal tip 118 of the barrel 102. In the embodiment shown in FIGS. 1-9, the cap 152 includes a recess 156 on the proximal side 151 of the cap for receiving the distal tip 118 of the barrel when the cap 152 is in the first position, which is the collapsed or covered position. Additionally, in the embodiment shown in FIGS. 1-9, an absorbent pad 154 is disposed on the distal side 153 of the cap 152. In the embodiment shown, the distal side 153 of the cap 152 includes a housing 158 that receives the absorbent pad 154.

[0024] 1-9, a syringe assembly including a barrel 102 includes a cap 152 that covers a distal tip 118 of the barrel 102, the cap 152 including a proximal side 151 that covers the distal tip 118, and a distal side 153 that includes an absorbent pad 154 mounted thereon. The cap 152 is pivotable from a first position in which the cap 152 covers the distal tip 118, to a second position in which the cap 152 is moved away from the distal tip 118. (rotate) In some embodiments, the cap 152 is rotatably disposed between the distal tip 118 and the open distal end 138 of the outer sleeve. In short, as shown (see Figures 10 to 17 for cap 252 described later), cap 152 is supported so as to be rotatable (pivotable) about a rotation axis located to the side of distal tip 118 of barrel 102, and cap 152 is positioned at a first position covering distal tip 118 and is supported so as to be rotatable (pivotable) to a second position away from distal tip 118 at the first position.

[0025] 5-7, the relative sliding motion of the outer sleeve 132 and barrel 102 moves the distal tip 118 of the barrel 102 and the open distal end 138 of the outer sleeve 132 toward one another, pushing the distal tip 118 and rotating the cap 152 at the distal tip from a first position to a second position. FIG. 5 shows the cap 152 being rotated in the direction of arrow 165 from a first position 152a, where the cap 152 covers the distal tip 118, to position 152b, where the cap 152 is rotated away from the distal tip to position 152c, and then to position 152d, where the cap 152 is in an uncovered position and the distal tip 118 is exposed, as shown in FIG. Relative sliding motion of the outer sleeve 132 and barrel occurs when a user of the syringe assembly applies a proximal force (in the direction of arrow 141 in FIG. 2) to the outer sleeve flange 139 while applying a distal force (in the direction of arrow 121 in FIG. 2) to the barrel flange 119. According to one or more embodiments, a user can use the syringe assembly 100 to flush a VAD and then use one hand to connect the syringe assembly to the VAD. For example, a user can hold the capped syringe assembly in a first position, as shown in FIGS. 2-4, by grasping and placing the outer sleeve between the index finger and middle finger. The user can then move the cap 152 and absorbent pad 154 out of the way by grasping the outer sleeve 132, placing the outer sleeve between the user's fingers, and applying a proximal force to the outer sleeve flange 139 by pressing the barrel flange 119 into the user's palm or thumb, as appropriate, thereby applying a distal force to the barrel flange 119. A user of the syringe assembly 100 applying force in this manner can squeeze the outer sleeve flange 139 and the barrel flange 119 toward each other, moving the cap 152 away from the distal tip 118 and exposing the distal tip 118, which can then be connected to a VAD.

[0026] Syringe assembly 100 is further shown as including a connection collar 170 surrounding distal tip 118 and an alignment collar 172 coaxial with connection collar 170, the alignment collar 172 including a peripheral tab 174 that engages outer sleeve 132. Outer sleeve 132 includes a slot 135 that cooperates with peripheral tab 174 to align cap 152 with open distal end 138 of outer sleeve 132 and guide relative sliding movement between barrel 102 and outer sleeve 132. In the illustrated embodiment and best seen in FIG. 7, outer sleeve slot 135 includes a detent 137 to prevent unintended relative movement of syringe barrel 102 and outer sleeve 132. FIGS. 2 and 4 show peripheral tab 174 below detent 137 in slot 135, which holds the assembly in a ready-to-use position. The peripheral tabs 174 and detents 137 in the slots 135 are configured such that a user must apply a sufficient amount of force to advance the peripheral tabs 174 past the detents 137 and move the cap from the first position to the second position. FIG. 7 shows the peripheral tabs 174 after they have advanced past the detents 137 and moved in a distal direction (indicated by arrow 121 in FIG. 2 ) to advance the distal tip 118 past the open distal end 138 of the outer sleeve to allow the distal tip to be connected to a VAD. In one or more embodiments, the alignment collar 172 can include multiple peripheral tabs 174, e.g., two, three, or more. The outer sleeve 132 can similarly include multiple slots 135 that cooperate with the peripheral tabs 174 to guide the outer sleeve 132 and barrel 102 during their relative sliding movement.

[0027] 10-17, a second embodiment of a flush syringe assembly 200 is shown. The flush syringe assembly 200 includes a barrel 202 including a sidewall 204 having an exterior surface 206, with an interior surface 208 defining a chamber 210 for holding a fluid. The barrel 102 further includes an open proximal end 112 and a distal end 114 including a distal wall 216 extending distally to a distal tip 218 having a first passageway 220 in fluid communication with the chamber 210.

[0028] The embodiment shown in Figures 10-17 further includes an outer sleeve 232 slidably engaged with the exterior surface 206 of the barrel 202, the outer sleeve 232 including an interior surface 234, an exterior surface 236, and an open distal end 238 at a peripheral distal surface 240. The syringe assembly 200 further includes a removable seal 250a disposed at the peripheral distal surface 240. The device further includes a cap 252 including an antiseptic and an absorbent pad 254 disposed between the removable seal 250 and the distal tip. The embodiment of Figures 10-17 further includes a stationary seal 250b disposed between the cap 252 and the absorbent pad 254. The cap 252 is rotatable from a first position in which the distal tip 218 of the barrel 202 is covered by the cap 252, and a second position in which the distal tip 218 of the barrel 202 is exposed through the open distal end 238 of the outer sleeve 232.

[0029] 11 and 12, the relative sliding motion of the outer sleeve 232 and barrel 202 moves the distal tip 218 of the barrel 202 and the open distal end 238 of the outer sleeve 232 toward one another, pushing the distal tip 218 and causing the distal tip to rotate the cap 252 from a first position to a second position. FIG. 13 shows the cap 252 rotating in the direction of arrow 265 from a first position 252a covering the distal tip 218 to position 252d, and as shown in FIGS. 14 and 15, the cap 252 rotates away from the distal tip to position 252c, and then to position 252d, a second position in which the cap 252 is uncovered and the distal tip 218 is exposed. Relative sliding motion of the outer sleeve 232 and barrel occurs when a user of the syringe assembly applies a proximal force (in the direction of arrow 241 in FIG. 11 ) to the outer sleeve flange 239 while applying a distal force (in the direction of arrow 221 in FIG. 11 ) to the barrel flange 219. According to one or more embodiments, a user can use the syringe assembly 100 to flush a VAD and then use one hand to connect the syringe assembly to the VAD. For example, a user can hold the capped syringe assembly in a first position, as shown in FIGS. 2-4 , by grasping and placing the outer sleeve between the index finger and middle finger. The user can then move the cap 252 and absorbent pad 254 out of the way by grasping the outer sleeve 232, placing the outer sleeve between the user's fingers, and pressing the barrel flange 219 into the user's palm or thumb, as appropriate, thereby applying a proximal force to the outer sleeve flange 139, which in turn applies a distal force to the barrel flange 119. A user of the syringe assembly 200 applying force in this manner can squeeze the outer sleeve flange 239 and the barrel flange 219 toward one another, moving the cap 252 away from the distal tip 118 and exposing the distal tip 218 for connection to a VAD. In the embodiment shown in Figures 10-17, rotation of the cap 252 pierces the static seal 250b and pushes the absorbent pad 254 through.

[0030] The syringe assembly 200 is further shown as including a connection collar 270 surrounding the distal tip 218 and an alignment collar 272 coaxial with the connection collar 270, the alignment collar 272 including a peripheral tab 274 that engages the outer sleeve 232. The outer sleeve 232 includes a slot 235 that cooperates with the peripheral tab 274 to align the cap 252 with the open distal end 238 of the outer sleeve 232 and guide relative sliding movement between the barrel 202 and the outer sleeve 232. In the illustrated embodiment and best seen in FIG. 7, the slot 235 in the outer sleeve includes a detent 237 to prevent unintended relative movement of the syringe barrel 202 and the outer sleeve 232. FIGS. 11 and 12 show the peripheral tab 274 below the detent 237 in the slot 235, which holds the assembly in a ready-to-use position. The peripheral tabs 274 and detents 237 in the slots 235 are configured such that a user must apply a sufficient amount of force to advance the peripheral tabs 274 past the detents 237 and move the cap from the first position to the second position. FIG. 15 shows the peripheral tabs 274 after they have advanced past the detents 237 and moved in a distal direction (indicated by arrow 221 in FIG. 11 ) to advance the distal tip 218 past the open distal end 238 of the outer sleeve to allow the distal tip to be connected to a VAD. In one or more embodiments, the alignment collar 272 can include multiple peripheral tabs 274, e.g., two, three, or more. The outer sleeve 232 can similarly include multiple slots 235 that cooperate with the peripheral tabs 274 to guide the outer sleeve 232 and barrel 202 during their relative sliding movement.

[0031] 10-17, the cap 252 may include a sharp edge 257 to aid in piercing the static seal 250b when the cap 252 is moved from the first position to the second position. The alignment collar 272 may also include a sharp feature 277, such as a spike, that may also pierce the static seal 252 when the user squeezes the outer sleeve flange 239 and barrel flange 219 to activate the device and expose the distal tip 218. The absorbent pad has a thickness and may have a pattern cut through its thickness to allow the cap 252 to push through the absorbent pad 254.

[0032] During use, a user of the syringe assembly 200 peels back the removable seal 250 to expose the absorbent pad 254, which can be used to clean or replace the VAD. During cleaning, the cap 252 is in a first position and the absorbent pad 254 is exposed through the open distal end 238 of the outer sleeve 232. Once the user has completed cleaning, the user can actuate the device as described above to place the cap 252 in a second position and rotate the cap 252 through the open distal end 238 of the outer sleeve 232 to expose the distal tip 218 of the barrel 202.

[0033] According to one or more embodiments, the removable seal of the embodiments described herein includes a peel back top of aluminum or multi-layer polymer film. The removable seal provides a liquid tight seal with a suitable adhesive that adheres the removable seal to the peripheral distal surface of the outer sleeve. The removable seal prevents the disinfectant from dissipating quickly, promoting a long shelf life. The removable seal can be chemically resistant, light-tight, impermeable, or sterile. In one or more embodiments, the connection collar includes a luer connector.

[0034] Although not shown in the figures, a syringe assembly according to one or more embodiments can further include a plunger rod including a distal end including a stopper slidably disposed in fluid-tight engagement with an inner surface of the barrel to draw fluid into and drive fluid from the chamber upon movement of the stopper relative to the barrel. The plunger rod extends outwardly from the open proximal end of the barrel.

[0035] The absorbent pad according to one or more embodiments absorbs a disinfectant or antimicrobial agent, which may be a liquid or gel selected from the group consisting of ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, and mixtures thereof.

[0036] The syringe assemblies described herein can be filled with flush solutions using known methods. Additionally, the syringe assemblies may be provided pre-filled from a manufacturer or supplier. The flush solution is any solution intended to flush or maintain the performance of the VAD. The flush solution can be selected from suitable flush solutions, such as saline flush solutions and heparin lock flush solutions. These solutions are known in the art and readily available. Examples of saline flush solutions include, but are not limited to, 0.9% sodium chloride USP for injection. Examples of heparin lock flush solutions include, but are not limited to, 0.9% sodium chloride with 100 USP units of heparin sodium per mL or 10 USP units of heparin sodium per mL.

[0037] Syringe assemblies can be used to flush vascular access devices such as catheters and IV sets, which can be quite complex and may contain multiple injection ports, valves, and / or other components.

[0038] There are two general classifications of VAD's: peripheral catheters and central venous catheters. Peripheral catheters are used to access veins at peripheral ends, such as the hand or annulus. Peripheral catheters are relatively short, ranging in length from about 14 mm to 48 mm, and are available in gauge sizes from about 16 to 24. The most commonly used peripheral catheters are believed to be 20 gauge, having an ID of about 0.8 lmm (0.032 inches), and 22 gauge, having an ID of about 0.66 mm (0.026 inches), and having a length of about 25 mm to 32 mm. As used herein, the term "peripheral catheter" is intended to refer to a 20 gauge or 22 gauge catheter having a length of about 25 mm. Central venous catheters are significantly longer than peripheral catheters, are inserted into the patient, and terminate close to the heart.

[0039] Another aspect of the present disclosure relates to a method of disinfecting a vascular access device, the method including exposing an absorbent pad containing a disinfectant at a distal end of a flush syringe assembly including a barrel having a distal tip covered by a cap, contacting the vascular access device with the absorbent pad, and then rotating the cap to expose the distal tip of the barrel. The method may further include utilizing an embodiment of a syringe assembly described herein, such as a syringe assembly including an outer sleeve having an open distal end and a distal end face that slidably engages the syringe barrel, the method further including sliding the syringe barrel and the outer sleeve relative to each other and rotating the cap away from the distal tip. Sliding the syringe barrel and the outer sleeve relative to each other rotates the cap away from the distal tip. Before sliding the outer sleeve and the barrel relative to each other, the user removes a removable seal from the distal end face of the outer sleeve to expose the absorbent pad. Before (or after) removing the removable seal, the user may remove the stopper. After scrubbing the VAD connector, the user slides off the outer sleeve to expose the syringe tip, attaches the syringe tip to the VAD connector, and the VAD is flushed. The syringe assembly is removed and discarded after the flushing procedure.

[0040] Although the present disclosure has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It is therefore to be understood that numerous modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope of the present disclosure as disclosed.

Claims

1. a barrel including a sidewall having an exterior surface, an interior surface defining a chamber for holding a fluid, an open proximal end, and a distal end including a distal wall extending distally therefrom with a distal tip having a first passageway through which said distal tip is in fluid communication with said chamber; an outer sleeve in slidable engagement with an outer surface of the barrel, the outer sleeve including an inner surface and an outer surface; a removable seal disposed on a peripheral distal surface of the outer sleeve; a cap containing an antiseptic and an absorbent pad disposed between the removable seal and the distal tip, the cap being rotatably supported about an axis of rotation located laterally of the distal tip of the barrel from a first position where the distal tip is covered by the cap to a second position where the distal tip of the barrel is exposed through the open distal end of the outer sleeve, the flush syringe assembly further comprising a static seal disposed between the cap and the removable seal, wherein rotation of the cap moves the cap through the static seal and through the absorbent pad to the second position.

2. 2. The flush syringe assembly of claim 1, further comprising an open distal end including a peripheral distal surface, wherein relative sliding movement of the outer sleeve and the barrel causes the distal tip to rotate the cap from the first position to the second position when the distal tip of the barrel and the distal end of the outer sleeve are brought closer together.

3. 3. The flush syringe assembly of claim 2, wherein the barrel further comprises a connection collar surrounding the distal tip and an alignment collar coaxial with the connection collar, the alignment collar comprising peripheral tabs that engage the outer sleeve.

4. 4. The flush syringe assembly of claim 3, wherein the outer sleeve includes a slot that cooperates with the peripheral tab to align the cap with the open distal end of the outer sleeve and guide relative sliding movement between the barrel and the outer sleeve.

5. 5. The flush syringe assembly of claim 4, wherein the slot in the outer sleeve includes a detent to prevent unintended relative movement of a syringe barrel and the outer sleeve.

6. The flush syringe assembly of claim 2 , wherein the absorbent pad is contained within the cap.

7. 7. The flush syringe assembly of claim 6, wherein said removable seal is peeled away to expose said absorbent pad.

8. 8. The flush syringe assembly of claim 7, wherein when the cap is in the first position, the absorbent pad is exposed through the open distal end of the outer sleeve, and when the cap is in the second position, the cap is rotated through the open distal end of the outer sleeve to expose the distal tip of the barrel.

9. The flush syringe assembly of claim 4 , wherein the absorbent pad is contained within the cap.

10. 10. The flush syringe assembly of claim 9, wherein when the cap is in the first position, the absorbent pad is exposed through the open distal end of the outer sleeve, and when the cap is in the second position, the cap is rotated through the open distal end of the outer sleeve to expose the distal tip of the barrel.

11. 10. The flush syringe assembly of claim 1, wherein the removable seal comprises a peel back top of aluminum or a multi-layer polymeric film.

12. The flush syringe assembly of claim 3 , wherein the connection collar comprises a Luer connector.

13. The flush syringe assembly of claim 1 , wherein the outer sleeve includes a flange at a proximal end and the barrel includes a barrel flange at the proximal end.

14. a barrel including a sidewall having an exterior surface, an interior surface defining a chamber for holding a fluid, an open proximal end, and a distal end including a distal wall extending distally therefrom with a distal tip having a first passageway through which said distal tip is in fluid communication with said chamber; an outer sleeve in slidable engagement with the barrel, the outer sleeve including an open distal end having an inner surface, an outer surface, and a peripheral distal surface; 11. A flush syringe assembly comprising: a cap covering the distal tip, the cap including a proximal side covering the distal tip and a distal side including an absorbent pad having an antiseptic or antimicrobial material mounted thereon, the cap supported for pivotal movement about an axis of rotation located to the side of the distal tip of the barrel from a first position where the cap covers the distal tip to a second position where the cap is spaced from the distal tip, allowing the distal tip to be connected to a vascular access device, the cap remaining connected to the outer sleeve after movement to the second position.

15. The flush syringe assembly of claim 14 , further comprising a removable seal disposed on the peripheral distal surface.

16. 16. The flush syringe assembly of claim 15, wherein the removable seal is peeled away to expose the absorbent pad.

17. 15. The flush syringe assembly of claim 14, wherein the relative sliding movement of the outer sleeve and the barrel brings a distal tip of the barrel and an open distal end of the outer sleeve into approximation, thereby pushing the distal tip, which rotates the cap from a first position to a second position.

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