Syringe with disinfection feature

Abstract

An injector assembly is described that includes an absorbent pad containing a disinfectant and a rotatable cap to ensure compliance with aseptic technique for use in a flushing procedure of a vascular access device (VAD). A method of disinfecting a vascular access device is also described.

Description

[0001] This application is a divisional application of Chinese patent application No. PCT / US2020 / 018760, Chinese application No. 202080015642.2, filed on February 19, 2020, entitled "Instrument with Sterilization Feature". Technical Field

[0002] This disclosure relates to syringe assemblies, and more particularly to syringe assemblies including sterilization caps for use in flushing procedures of vascular access devices (VADs). Background Technology

[0003] Vascular access devices are commonly used therapeutic devices and include intravenous (IV) catheters. Vascular access devices are generally classified into two categories: peripheral catheters and central venous catheters. To ensure the proper use and maintenance of vascular access devices, several practice standards have been established, including cleaning procedures, often referred to as catheter flushing.

[0004] Standard practice guidelines for vascular access devices typically recommend flushing procedures after catheter placement and before fluid infusion, as well as before and after drug administration, blood collection, transfusion, and parenteral nutrition. The goals of these flushing procedures are to confirm catheter patency, avoid drug incompatibilities, ensure complete drug dosing, prevent thrombosis, and minimize the risk of bloodstream infection. Flushing procedures require different types and volumes of flushing solutions. The most commonly used flushing solutions are normal saline and / or heparinized locking solution. The type and volume of flushing solution vary depending on the specific type of catheter. Flushing solution volumes of 5 to 10 ml are most common, but the range can be from 1 to 20 ml.

[0005] For flushing procedures, intravenous lines refer to systems that may include vascular access devices, tubing assemblies with clamps, and vascular access device connectors as terminals. Common types of vascular access device connectors are covered by a puncture-resistant diaphragm or a pre-stitched diaphragm made of rubber or other elastic materials, which allows insertion of a sharp needle cannula to inject or withdraw fluid into or from the catheter. The diaphragm self-seales upon needle cannula removal. Ports with pre-stitched diaphragms are used with the blunt, truncated conical tip of a plastic cannula or syringe barrel. The syringe tip or blunt plastic cannula (usually attached to a syringe) is gently pushed through the pre-stitched diaphragm to establish fluid communication.

[0006] Intravenous valves are another type of vascular access device connector that does not require a needle with a sharp tip. These valves are actuated by a truncated conical tip of the syringe barrel to allow fluid communication between the syringe interior 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.

[0007] When connecting to a vascular access device to deliver fluids or medications, bacteria and other microorganisms can enter the patient's vascular system from the access hub and port / valve. Each access hub (or port / valve or connection) carries a risk of catheter-associated bloodstream infection (CRBSI), which can be costly and potentially fatal. Contamination can occur during medication mixing, cannulation attachment, and insertion into the access hub. Currently, the risk to hospitals and patients largely depends on the diligence of clinicians performing the connection, which is largely uncontrollable.

[0008] Currently available products designed to address issues related to contaminated vascular access device connectors are: This device sterilizes the vascular access device connector by covering it and protecting it from contact and airborne contamination after a cap has been applied. When When screwed onto the vascular access device connector, the foam pad inside the cap is compressed, releasing isopropyl alcohol upon placement to passively sterilize the top and threads of the connector. Because As it is a separate component, errors are possible, and the cap may become unusable after each step of the rinsing process. Therefore, this cap cannot guarantee compliance with aseptic techniques.

[0009] Therefore, there is a need for a flushing syringe assembly that facilitates compliance with aseptic techniques by eliminating additional wiping and disinfection steps. Summary of the Invention

[0010] This disclosure relates to syringe assemblies for use in rinsing applications and methods for sterilizing syringes. A syringe assembly (e.g., a rinsing syringe assembly according to a first aspect of this disclosure) includes a barrel comprising a sidewall, a proximal end with an opening, and a distal end including a distal sidewall having an outer surface and an inner surface defining a chamber for retaining fluid, wherein a distal tip extends distally from the distal sidewall, the distal tip having a first channel in fluid communication with the chamber; a removable seal disposed on the distal peripheral surface; a cap disposed between the removable seal and the distal tip; and an absorbent pad containing a disinfectant, the cap being rotatable from a first position covered by the cap from the distal tip to a second position where the distal tip of the barrel is exposed through the distal end of the opening of an outer sleeve. In some embodiments, the assembly further includes an outer sleeve slidably engaged with the outer surface of the cylinder, the outer sleeve including an inner surface, an outer surface, and an open distal end including a peripheral distal surface, wherein relative sliding movement between the outer sleeve and the cylinder causes the distal tip of the cylinder and the distal end of the outer sleeve to move closer together, thereby causing the distal tip to rotate the cap from a first position to a second position.

[0011] In a second embodiment, the syringe assembly (e.g., a flushing syringe assembly) includes a barrel comprising a sidewall, a proximal end with an opening, and a distal end including a distal sidewall. The sidewall has an outer surface and an inner surface defining a chamber for holding fluid. A distal tip extends distally from the distal sidewall, having a first channel in fluid communication with the chamber. A cap covers the distal tip, the cap comprising a proximal side covering the distal tip and a distal side on which an absorbent pad is mounted, the cap being pivotally movable from a first position where the cap covers the distal tip to a second position where the cap is removed from the distal tip.

[0012] A second aspect of this disclosure relates to a method for disinfecting a vascular access device. According to one embodiment, the method includes: exposing an absorbent pad containing a disinfectant at the distal end of a flushing syringe assembly including a barrel having a distal tip covered by a cap; contacting the vascular access device with the absorbent pad; and rotating the cap to expose the distal tip of the barrel. Attached Figure Description

[0013] Figure 1 This is an exploded perspective view of a flushing syringe assembly according to one embodiment of the present disclosure;

[0014] Figure 2 This is a perspective view of a flushing syringe assembly according to an embodiment of the present disclosure;

[0015] Figure 3 yes Figure 2 Enlarged partial sectional side view of the flushing syringe assembly;

[0016] Figure 4It is shown Figure 2 A partial three-dimensional view of the distal portion of the flushing syringe assembly;

[0017] Figure 5 yes Figure 2 A three-dimensional view of a flushing syringe, in which the cap extends from the distal end of the flushing syringe;

[0018] Figure 6 yes Figure 2 A magnified partial sectional side view of the flushing syringe, in which the cap extends from the distal end of the flushing syringe;

[0019] Figure 7 yes Figure 2 A partial three-dimensional view of a flushing syringe, in which the cap extends from the distal end of the flushing syringe;

[0020] Figure 8A yes Figure 2 A three-dimensional view of the distal side of the cap of a flushing syringe;

[0021] Figure 8B yes Figure 2 A three-dimensional view of the near-side view of the cap of the rinsing syringe;

[0022] Figure 9 yes Figure 2 A three-dimensional view of the alignment collar of the flushing syringe;

[0023] Figure 10 This is an exploded perspective view of the flushing syringe assembly according to the second embodiment of the present disclosure;

[0024] Figure 11 This is a perspective view of the flushing syringe assembly according to the second embodiment of the present invention;

[0025] Figure 12 yes Figure 11 Enlarged partial sectional side view of the flushing syringe assembly, with the cap in the retracted position;

[0026] Figure 13 yes Figure 11 A magnified partial cross-sectional side view of the flushing syringe assembly, wherein the cap is shown moving from the retracted position to the extended position;

[0027] Figure 14 yes Figure 11 A magnified partial sectional side view of the flushing syringe assembly, wherein the cap is positioned to extend from the distal end of the flushing syringe;

[0028] Figure 15 It is a partial three-dimensional view of the distal end of the flushing syringe assembly, with the cap in the extended position;

[0029] Figure 16A yes Figure 11 A perspective view of the distal side of the cap of the flushing syringe assembly;

[0030] Figure 16B yes Figure 11 A perspective view of the cap of the flushing syringe assembly from near the side; and

[0031] Figure 17 yes Figure 11 A perspective view of the alignment collar of the flushing syringe assembly. Detailed Implementation

[0032] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can be implemented in other ways and can be practiced or performed in various manner.

[0033] The following definitions are provided for the terms used in this disclosure.

[0034] The “flushing syringe assembly” mentioned includes syringes specified for use in the flushing of vascular access devices. Flushing practices ensure and maintain catheter patency and help prevent the mixing of incompatible drugs.

[0035] As used herein, the words “a,” “one,” and “the” include both singular and plural forms. The term “catheter-associated bloodstream infection” or “CRBSI” as used herein refers to any infection resulting from the presence of a catheter or intravenous line. The term “microbe” as used herein refers to a single-celled organism or microorganism living in a community of cellular organisms. Microbes are highly diverse; they include, but are not limited to, bacteria, fungi, archaea, and protozoa. Microbes are commonly the cause of CRBSI. The most common microbes associated with CRBSI include, but are not limited to, Staphylococcus aureus and Staphylococcus epidermidis, Enterococcus faecalis, Escherichia coli, Pseudomonas aeruginosa, and Candida albicans.

[0036] 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. Antimicrobial agents either kill microorganisms or prevent their growth. The term "disinfectant" as used herein refers to an antimicrobial substance applied to inanimate objects or externally (e.g., on the skin). In one or more embodiments, disinfectants or antimicrobial agents include, but are not limited to, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, and mixtures thereof.

[0037] As used herein, the terms "absorbent material" and "absorbent pad" refer to materials that have the ability or tendency to absorb or adsorb another substance. In one or more embodiments, the absorbent material or absorbent pad has a tendency to absorb disinfectants or antibacterial agents. Absorbent materials and absorbent pads may include sponges, absorbent cotton, foam, other absorbent fabrics, and synthetic polymer matrices.

[0038] As used herein, the term "Luer connector" refers to a connecting collar, a standard method for attaching syringes, catheters, hubed needles, intravenous catheters, etc., to each other. Luer connectors consist of a convex-concave interlocking tube that tapers slightly to better hold them together, even under simple pressure / torsion fits. Luer connectors may optionally include additional threaded outer edges for added strength. The convex end of the Luer connector is typically associated with a flushing syringe and can interlock with and connect to the concave end on a vascular access device. The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a shaped central channel for fluid communication from the syringe barrel chamber to the hub of the vascular access device. The Luer connector also has a distal end channel for releasable attachment of the Luer connector to the hub of the vascular access device and a proximal end channel for releasable attachment of the Luer connector to the syringe barrel.

[0039] According to one or more embodiments, a syringe assembly is provided, comprising an absorbent material or pad containing a disinfectant or antimicrobial substance, the absorbent material or pad being removed 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, allowing access to ports that are typically difficult to access, such as Y-connectors. According to one or more embodiments, device actuation is achieved by squeezing two portions of the syringe assembly together to expose the disinfectant. This allows the user of the assembly to actuate the device with one hand, thus preventing workflow interruptions.

[0040] Now refer to Figures 1 to 9 This illustration shows a first embodiment of a flushing syringe assembly 100. The flushing syringe assembly 100 includes a barrel 102, which includes a sidewall 104 having an outer surface 106 and an inner surface 108 defining a chamber 110 for holding fluid. The barrel 102 also includes a proximal end 112 with an opening and a distal end 114 including a distal sidewall 116, wherein a distal tip 118 extends distally from the distal sidewall 116, the distal tip 118 having a first channel 120 in fluid communication with the chamber 110.

[0041] Figures 1 to 11The illustrated embodiment also includes an outer sleeve 132 slidably engaged with the outer surface 106 of the barrel 102, the outer sleeve 132 including an inner surface 134, an outer surface 136, and a distal end 138 including an opening with a distal peripheral surface 140. The syringe assembly 100 also includes a removable seal 150 disposed on the distal peripheral surface 140. The device also includes a cap 152 disposed between the removable seal 150 and the distal tip, and an absorbent pad 154 containing disinfectant, the cap 152 being rotatable between a first position where the distal tip 118 of the barrel 102 is covered by the cap 152 and a second position where the distal tip 118 of the barrel 102 is exposed through the opening distal end 138 of the outer sleeve 132.

[0042] Figures 2 to 4 A flushing syringe assembly 100 in a first position is shown, wherein the distal tip 118 of the barrel 102 is covered by a 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. Figures 1 to 9 In the illustrated embodiment, the cap 152 includes a recess 156 on its proximal side 151 for receiving the distal tip 118 of the tube when the cap 152 is in a first position, which is a folded-down or covered position. Furthermore, in Figures 1 to 9 In the illustrated embodiment, the absorbent pad 154 is located on the distal side 153 of the cap 152. In the illustrated embodiment, the distal side 153 of the cap 152 includes a housing 158 for receiving the absorbent pad 154.

[0043] Therefore, in Figures 1 to 9 In the illustrated embodiment, the syringe assembly including the barrel 102 includes a cap 152 covering the distal tip 118 of the barrel 102, wherein the cap 152 includes a proximal side 151 covering the distal tip 118 and a distal side 153 thereon on which an absorbent pad 154 is mounted. The cap 152 can be pivotally moved from a first position where the cap 152 covers the distal tip 118 to a second position where the cap 152 is removed from the distal tip 118. In some embodiments, the cap 152 is rotatably disposed between the distal tip 118 and the distal end 138 of the opening of the outer sleeve.

[0044] Now refer to Figures 5 to 7 The relative sliding motion between the outer sleeve 132 and the sleeve 102 causes the distal tip 118 of the sleeve 102 and the distal end 138 of the opening of the outer sleeve 132 to move closer together, which pushes the distal tip 118, thereby causing the distal tip to rotate the cap 152 from the first position to the second position. Figure 5The cap 152 is shown, rotating along the direction of arrow 165 from a first position 152a covering the distal tip 118, to position 152b, to position 152c, and then to position 152d, where the cap 152 is in an uncovered position, thus exposing the distal tip 118. Figure 7 As shown. When the user of the syringe assembly applies a proximal force (along the outer sleeve flange 139) to the syringe assembly... Figure 2 (in the direction of the middle arrow 141) and simultaneously apply a force pointing distally to the cylinder flange 119 (along the direction of the middle arrow 141). Figure 2 When the direction of the middle arrow 121 is indicated, a relative sliding movement occurs between the outer sleeve 132 and the body. According to one or more embodiments, a user can clean the vascular access device with the syringe assembly 100 and then connect the syringe assembly to the vascular access device with one hand. For example, the user can grasp the outer sleeve by placing it between the index and middle fingers of their hand while the cap is in position. Figures 2 to 4 The syringe assembly is held in the first position shown. The user can then remove the cap 152 and absorbent pad 154 by grasping the outer sleeve 132, applying a proximal force to the outer sleeve flange 139 by placing the outer sleeve between the user's fingers, and applying a distal force to the barrel flange 119 by pressing it into the user's palm or thumb as needed. The user of the syringe assembly 100 applies force in this way to press the outer sleeve flange 139 and barrel flange 119 toward each other, removing the cap 152 from the distal tip 118 and exposing the distal tip 118, which can then be connected to a vascular access device.

[0045] The syringe assembly 100 is also shown as including a connecting collar 170 surrounding a distal tip 118 and an alignment collar 172 coaxial with the connecting collar 170. The alignment collar 172 includes a peripheral tab 174 that engages with an outer sleeve 132. The outer sleeve 132 includes a slot 135 that engages with the peripheral tab 174 to align the cap 152 with the distal end 138 of the opening of the outer sleeve 132 and to guide relative sliding between the syringe body 102 and the outer sleeve 132. Figure 7 In the preferred embodiment shown, the slot 135 in the outer sleeve includes a stop 137 to prevent accidental relative movement between the syringe barrel 102 and the outer sleeve 132. Figure 2 and Figure 4 A peripheral tab 174 is shown below a stop 137 in slot 135, which holds the assembly in a ready-to-use position. The peripheral tab 174 and the stop 137 in slot 135 are configured such that the user must apply sufficient force to push the peripheral tab 174 through the stop 137, thereby moving the cap from a first position to a second position. Figure 7 This shows the peripheral protrusion 174 after it has been advanced through the stop 137, which is in the distal direction (by...) Figure 2 (Indicated by the middle arrow 121) Movement advances the distal tip 118 through the distal end 138 of the opening in the outer sleeve, allowing the distal tip to be connected to the vascular access device. In one or more embodiments, the alignment collar 172 may include a plurality of peripheral tabs 174, such as two, three, or more. The outer sleeve 132 may similarly include a plurality of slots 135 that engage with the peripheral tabs 174 to guide the outer sleeve 132 and the sleeve 102 during relative sliding movements.

[0046] Now refer to Figures 10 to 17 This illustrates a second embodiment of the flushing syringe assembly 200. The flushing syringe assembly 200 includes a barrel 202, which includes a sidewall 204 having an outer surface 206 and an inner surface 208 defining a chamber 210 for holding fluid. The barrel 102 also includes a proximal end 112 with an opening and a distal end 114 including a distal sidewall 216, wherein a distal tip 218 extends distally from the distal sidewall 216, the distal tip 218 having a first channel 220 in fluid communication with the chamber 210.

[0047] Figures 10 to 17 The illustrated embodiment also includes an outer sleeve 232 slidably engaged with the outer surface 206 of the barrel 202, the outer sleeve 232 including an inner surface 234, an outer surface 236, and an open distal end 238 including a peripheral distal surface 240. The syringe assembly 200 also includes a removable seal 250a disposed on the peripheral distal surface 240. The device also includes a cap 252 disposed between the removable seal 250 and the distal tip, and an absorbent pad 254 containing disinfectant. Figures 10 to 17 The embodiment also includes a fixing seal 250b disposed between the cap 252 and the absorbent pad 254. The cap 252 can be rotated from a first position where the distal tip 218 of the cylinder 202 is covered by the cap 252 to a second position where the distal tip 218 of the cylinder 202 is exposed through the distal end 238 of the opening of the outer sleeve 232.

[0048] Now refer to Figure 11 and Figure 12 The relative sliding motion between the outer sleeve 232 and the cylinder 202 causes the distal tip 218 of the cylinder 202 and the distal end 238 of the opening of the outer sleeve 232 to move closer together, which pushes the distal tip 218, thereby causing the distal tip to rotate the cap 252 from the first position to the second position. Figure 13The cap 252 is shown in the direction of arrow 265, starting from a first position 252a covering the distal tip 218, rotating to position 252b, then to position 252c, and finally to position 252d. In position 252d, the cap 252 is in a second position, which is an uncovered position, with the distal tip 218 exposed, as shown... Figure 14 and Figure 15 As shown. When the user of the syringe assembly applies a proximal force (along the outer sleeve flange 239) to the syringe assembly... Figure 11 (in the direction of the middle arrow 241) and simultaneously apply a force pointing distally to the cylinder flange 219 (along the direction of the middle arrow 241). Figure 11 When the direction of the middle arrow 221 is indicated, a relative sliding movement occurs between the outer sleeve 232 and the body. According to one or more embodiments, a user can clean the vascular access device with the syringe assembly 100 and then connect the syringe assembly to the vascular access device with one hand. For example, the user can grasp the outer sleeve by placing it between the index and middle fingers of their hand while the cap is in position. Figures 2 to 4 The syringe assembly is held in the first position shown. The user can then remove the cap 252 and absorbent pad 254 by grasping the outer sleeve 232, applying a proximal force to the outer sleeve flange 239 by placing the outer sleeve between the user's fingers, and applying an outward force to the barrel flange 219 by pressing it into the user's palm or thumb as needed. The user of the syringe assembly 200 applies force in this way to press the outer sleeve flange 239 and barrel flange 219 toward each other, removing the cap 252 from the distal tip 218 to expose the distal tip 218, which can then be connected to the vascular access device. Figures 10 to 17 In the embodiment shown, the rotation of the cap 252 pierces the fixed seal 250b and pushes it through the absorbent pad 254.

[0049] The syringe assembly 200 is also shown to include a connecting collar 270 surrounding a distal tip 218 and an alignment collar 272 coaxial with the connecting collar 270. The alignment collar 272 includes a peripheral tab 274 that engages with an outer sleeve 232. The outer sleeve 232 includes a slot 235 that engages with the peripheral tab 274 to align the cap 252 with the distal end 238 of the opening of the outer sleeve 232 and to guide relative sliding movement between the syringe body 202 and the outer sleeve 232. Figure 7 In the preferred embodiment shown, the slot 235 in the outer sleeve includes a stop 237 to prevent accidental relative movement between the syringe barrel 202 and the outer sleeve 232. Figure 11 and 12A peripheral tab 274 is shown below a stop 237 in slot 235, which holds the assembly in a ready-to-use position. The peripheral tab 274 and the stop 237 in slot 235 are configured such that the user must apply sufficient force to push the peripheral tab 274 through the stop 237, thereby moving the cap from a first position to a second position. Figure 15 This shows the peripheral protrusion 274 after it has been advanced through the stop 237, which is in the distal direction (by...) Figure 11 (Indicated by the middle arrow 221) Movement advances the distal tip 218 through the distal end 238 of the opening in the outer sleeve, allowing the distal tip to be connected to the vascular access device. In one or more embodiments, the alignment collar 272 may include a plurality of peripheral tabs 274, such as two, three, or more. The outer sleeve 232 may similarly include a plurality of slots 235 that engage with the peripheral tabs 274 to guide the outer sleeve 232 and the sleeve 202 during relative sliding movements.

[0050] exist Figures 10 to 17 In the illustrated embodiment, the cap 252 may include a sharp edge 257 to aid in piercing the retaining seal 250b as the cap 252 moves from a first position to a second position. The alignment collar 272 may also include a sharp feature 277, such as a stud, which may also pierce the retaining seal 252 when the user squeezes the outer sleeve flange 239 and the body flange 219 to actuate the device, exposing the distal tip 218. The absorbent pad has a thickness and may have a cut pattern extending through that thickness to allow the cap 252 to be pushed through the absorbent pad 254.

[0051] In use, when the user peels off the removable seal 250 from the syringe assembly 200, the absorbent pad 254 is exposed and can be used to clean or replace the vascular access device. During cleaning, the cap 252 is in a first position, and the absorbent pad 254 is exposed through the distal end of the opening of the outer sleeve 232. When the user has finished 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 distal end 238 of the opening of the outer sleeve 232 to expose the distal tip 218 of the barrel 202.

[0052] According to one or more embodiments, the removable seal of the embodiments described herein comprises an aluminum or multilayer polymer film peel-off back top. The removable seal provides a liquid-tight seal via a suitable adhesive that adheres the removable seal to the distal peripheral surface of the outer sleeve. The removable seal prevents disinfectant from dissipating too quickly and helps extend shelf life. The removable seal may be chemically resistant, light-shielding, impermeable, or sterile. In one or more embodiments, the connecting collar comprises a Luer connector.

[0053] Although not shown in the figures, the syringe assembly according to one or more embodiments may also include a plunger rod including a distal end comprising a plug slidably positioned to fluid-tightly engage with an inner surface of the barrel for drawing in or expelling fluid from a chamber by movement of the plug relative to the barrel. The plunger rod extends outward from the proximal end of the opening of the barrel.

[0054] The absorbent pad according to one or more embodiments absorbs a disinfectant or antibacterial agent. The disinfectant or antibacterial agent may be a fluid or gel selected from the group consisting of ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, and mixtures thereof.

[0055] The syringe assembly described herein can be filled with a flushing solution using known methods. Furthermore, the syringe assembly may be pre-filled by the manufacturer or supplier. The flushing solution can be any solution used for flushing or maintaining the performance of a vascular access device. The flushing solution can be selected from suitable flushing solutions such as normal saline flushing solutions and heparin lock flushing solutions. These solutions are known in the art and are readily available. Examples of saline flushing solutions include, but are not limited to, 0.9% sodium chloride for injection (USP). Examples of heparin lock flushing solutions include, but are not limited to, 0.9% sodium chloride containing 100 USP units of heparin sodium per milliliter or 10 USP units of heparin sodium per milliliter.

[0056] Syringe assemblies can be used to flush vascular access devices such as catheters or intravenous kits. Intravenous kits can be very complex and may include multiple injection ports, valves, and / or other components.

[0057] Vascular access devices are generally classified into two categories: peripheral catheters and central venous catheters. Peripheral catheters are used to access veins in the four peripheral limbs, such as the hand and arm. Peripheral catheters are relatively short, ranging in length from approximately 14 mm to 48 mm, and are available in sizes from approximately 16 to 24. The most commonly used peripheral catheters are considered to be size 20 (approximately 0.81 mm, 0.032 inches) in diameter and approximately 25 mm to 32 mm in length) and size 22 (approximately 0.66 mm, 0.026 inches) in diameter and approximately 25 mm to 32 mm in length). The term "peripheral catheter" as used herein refers to size 20 or 22 catheters with a length of approximately 25 mm. Central venous catheters are significantly longer than peripheral catheters and are inserted into the patient's body, terminating near the heart.

[0058] Another aspect of this disclosure relates to a method of disinfecting a vascular access device. The method includes: exposing an absorbent pad containing disinfectant at the distal end of a flushing 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 implementations using the syringe assembly described herein, such as a syringe assembly including an outer sleeve having an open distal end and a distal end face slidably engaged with the syringe barrel, and the method further includes sliding the syringe barrel and outer sleeve relative to each other, causing the cap to rotate away from the distal tip. Before sliding the outer sleeve and barrel relative to each other, a 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 break the plug. After wiping the vascular access device connector, the user slides the outer sleeve to expose the syringe tip, attaches the syringe tip to the vascular access device connector, and then flushes the vascular access device. The syringe assembly is then removed and discarded after the flushing procedure.

[0059] While the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. Therefore, it is understood that various modifications and other arrangements can be contemplated of the illustrated embodiments without departing from the spirit and scope of this disclosure.

Claims

1. A flushing syringe assembly, comprising: A cylindrical body, the cylindrical body comprising: a sidewall having an outer surface and an inner surface defining a chamber for retaining fluid; a proximal end with an opening; and a distal end including a distal sidewall, wherein a distal tip extends distally from the distal sidewall, the distal tip having a first channel through which it is in fluid communication with the chamber; An outer sleeve slidably engages with the outer surface of the cylinder, the outer sleeve including an inner surface, an outer surface, a distal end of an opening, and an outer sleeve flange, the distal end of the opening including a distal outer peripheral surface; A removable seal is provided on the distal surface of the outer periphery; and A cap covering the distal tip, the cap including a proximal side and a distal side, the proximal side covering the distal tip of the tube body, the distal side including an absorbent pad mounted thereon and containing disinfectant, wherein, when a proximal force is applied to the outer sleeve flange and a distal force is applied to the tube body flange, a relative sliding movement occurs between the outer sleeve and the tube body, and the distal tip of the tube body and the distal end of the opening of the outer sleeve are brought closer together, thereby causing the distal tip (118) to rotate the cap from a first position in which the distal tip is covered by the cap to a second position in which the cap moves away from the distal tip and the distal tip of the tube body is exposed through the distal end of the opening of the outer sleeve to allow the distal tip to be connected to a vascular access device, and after moving to the second position, the cap remains connected to the outer sleeve.

2. The flushing syringe assembly as claimed in claim 1, wherein, The removable seal comprises aluminum or a multilayer polymer film.

3. The flushing syringe assembly as claimed in claim 1, wherein, The cylinder also includes a connecting collar surrounding the distal end and an alignment collar coaxial with the connecting collar, the alignment collar including an outer peripheral tab that engages the outer sleeve.

4. The flushing syringe assembly as claimed in claim 3, wherein, The connecting collar includes a Luer connector.

5. The flushing syringe assembly as claimed in claim 1, wherein, The outer sleeve includes a flange at the proximal end of the outer sleeve, and the cylinder body includes a cylinder body flange at the proximal end of the cylinder body.

6. The flushing syringe assembly as claimed in claim 1, wherein, Removing the removable seal will expose the absorbent pad.

7. The flushing syringe assembly as claimed in claim 1, wherein, The cap includes a recess on its proximal side for receiving the distal tip of the tube when the cap is in a first position, which is a downward folded or covered position.

8. The flushing syringe assembly as claimed in claim 1, wherein, The distal side of the cap includes a housing for receiving the absorbent pad.

9. The flushing syringe assembly as claimed in claim 3, wherein, The alignment collar includes peripheral tabs that engage with the outer sleeve.

10. The flushing syringe assembly of claim 9, wherein, The outer sleeve includes a slot that engages with the peripheral tab to align the cap with the distal end of the opening of the outer sleeve and to guide relative sliding between the sleeve and the outer sleeve.

11. The flushing syringe assembly of claim 10, wherein, The slot in the outer sleeve includes a stop to prevent accidental relative movement between the syringe barrel and the outer sleeve.

12. The flushing syringe assembly of claim 11, wherein, The peripheral tab is located below the stop in the slot, and the peripheral tab holds the flushing syringe assembly in a ready-to-use position.

13. The flushing syringe assembly of claim 12, wherein, The peripheral tab and the stop in the slot are configured such that the user must apply sufficient force to push the peripheral tab through the stop, thereby moving the cap from the first position to the second position.

14. The flushing syringe assembly of claim 13, wherein, After the peripheral tab has been advanced through the stop, the distal tip is advanced through the distal end of the opening of the outer sleeve, so that the distal tip can be connected to the vascular access device.

15. The flushing syringe assembly of claim 14, wherein, The alignment collar includes a plurality of peripheral tabs, and the outer sleeve includes a plurality of slots that cooperate with the peripheral tabs to guide the outer sleeve and the sleeve during relative sliding motion.

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