Intravascular catheter care before and after flushing

Abstract

An intravascular catheter care device including a flush syringe with an integrated disinfection unit and an associated method for disinfecting an intravascular catheter, the disinfection unit including a first disinfection pad enclosed between first and second layers of flexible release film. The first layer can be removed from the second layer to expose the first disinfection pad. The second disinfection pad can be enclosed either between the second layer of release film and a third layer of release film, or between the second layer of release film and a cap that can be secured to a connector. The second layer can be removed from the third layer or the cap to expose the second disinfection pad. The first pad can be used to disinfect the connector of the intravascular catheter before flushing, and the second pad can be used after flushing.

Description

[Technical Field]

[0001] This application claims priority to U.S. Utility Application No. 17 / 989,306, entitled "Intravascular Catheter Care Pre- and Post-Flushing," filed November 17, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to catheter device care, and more particularly to an integrated intravascular catheter cleaning and disinfection device for use in disinfecting a catheter's connector before and after flushing the catheter. [Background technology]

[0003] Standards of care and practice for intravascular catheters typically recommend performing flush procedures after catheter placement, before fluid infusion, and before and after drug administration, blood withdrawal, transfusion, and parenteral nutrition. The purpose of these flush procedures is to confirm catheter patency, avoid drug incompatibilities, ensure complete drug administration, prevent thrombus formation, and minimize the risk of bloodstream infection.

[0004] Catheter-associated bloodstream infections are common and caused by bacteria or fungi in patients with intravascular (IV) catheters. These infections can lead to significant illness and death, as well as excessive medical costs. Current recommended practice is for physicians to implement a step-by-step disinfection process. This process requires several disinfection steps, such as pre-flushing and post-flushing, before pushing medications or withdrawing fluids through the catheter port and IV line, making intravascular catheter care and IV line maintenance a very burdensome and time-consuming process.

[0005] Protective caps or syringe collars containing disinfectants and / or antibacterial agents have been designed as a way to reduce these infections. These caps or collars can be attached to the flush syringe outlet port or IV port before connecting the flush syringe to the catheter port as a way to reduce infection. However, these additional caps / collars can be difficult to manipulate or attach to the syringe or IV port, leading to operator error. Furthermore, the use of these caps / collars increases the overall cost of the device due to the increased number of manufactured components, increased packaging costs, and increased storage space due to the larger footprint created by these caps / collars.

[0006] An IV connector cleaning device integrated with a flush syringe to disinfect the connector in a cost-effective manner would be beneficial in reducing infection while reducing manufacturing and storage costs. Summary of the Invention

[0007] Thus, improved systems, devices, products, apparatus, and / or methods are provided for intravascular catheter care and cleaning in a cost-effective manner, having fewer manufacturing parts and requiring less packaging and storage space.

[0008] According to one aspect, the present disclosure is directed to an intravascular catheter care device comprising a flush syringe configured to flush an intravascular catheter and a disinfection unit associated with the flush syringe. The disinfection unit can be attached to the flush syringe, allowing a user to intuitively clean the connector before accessing an IV. According to one embodiment, the disinfection unit can be attached to the distal tip of the flush syringe. According to another embodiment, the disinfection unit can be attached to the outer wall of the barrel of the flush syringe. The disinfection unit can be attached to the flush syringe by any known technique, including, but not limited to, the use of pressure- or temperature-sensitive adhesives, mechanical attachment, thermoforming or injection molding with one or more frangible portions that allow the disinfection unit to be removed from the flush syringe, etc.

[0009] In another embodiment, instead of attaching the sterilization unit to the flush syringe itself, the sterilization unit can be packaged together with the flush syringe.

[0010] The disinfection unit includes at least a first disinfection pad enclosed within a flexible release film. The release film can include a first layer and a second layer, with the first layer configured to be removed from the second layer to expose the first disinfection pad. The first disinfection pad is removable from the disinfection unit for cleaning one of the intravascular catheter's connectors or pre- or post-flush cleaning. The remaining components of the disinfection unit can be set aside for future use. The first disinfection pad can have a patterned surface configured to enhance the efficiency of scrubbing and disinfecting the pad and can be formed from a woven or foam material. The first disinfection pad can be soaked in any known disinfecting or antibacterial material, such as, for example, a 70% aqueous isopropyl alcohol solution.

[0011] According to one embodiment, the first antiseptic pad can be pre-flushed, and the antiseptic unit can further include a second antiseptic pad configured to clean the connector of the intravascular catheter. A second layer of release film can separate the first antiseptic pad from the second antiseptic pad, and the second layer can be configured to be removed from the first layer to expose the second antiseptic pad. According to one design, the release film can include a third layer, and the second antiseptic pad is enclosed between the second and third layers. According to another design, the antiseptic unit can include a cap, and the second antiseptic pad is disposed within the cap, and the second layer forms a seal with the cap to enclose the second antiseptic pad therein. The cap containing the second antiseptic pad can be configured to be removably secured to the connector so that the second antiseptic pad contacts the connector after flushing. It can be understood that the cap can be secured to the connector by any known arrangement, such as a threaded engagement, a slip-fit ​​engagement, or the like.

[0012] Like the first antiseptic pad, the second antiseptic pad can have a patterned surface to enhance its scrubbing and disinfecting efficiency, and can be soaked with a known antiseptic solution.

[0013] According to another aspect, the present disclosure is directed to an intravascular catheter care device including a flush syringe configured to flush an intravascular catheter and a disinfection unit associated with the flush syringe. The disinfection unit can include at least a first disinfection pad enclosed within a flexible release film. The release film includes a first layer and a second layer, the first layer configured to be removed from the second layer to expose the first disinfection pad. The disinfection unit can further include at least a second disinfection pad, the second disinfection pad enclosed (sealed) between either the second layer of release film and a third layer of release film, or between the second layer of release film and a cap. The second layer is configured to be removed from either the third layer or the cap to expose the second disinfection pad. The first disinfection pad is removable from the disinfection unit, allowing a user to disinfect the connector of the intravascular catheter before flushing or pre-flush, and the second disinfection pad can be used to disinfect the intravascular catheter after flushing or flushing.

[0014] The first and second antiseptic pads can have patterned surfaces configured to enhance the scrubbing and disinfecting efficiency of the pads. According to one embodiment, the first and second antiseptic pads can be submerged in a disinfecting solution. It can be appreciated that any known disinfecting or antibacterial material can be used to submerge the first and second antiseptic pads. One example of a disinfecting material that can be used includes a 70% aqueous isopropyl alcohol solution.

[0015] In designs in which the disinfection unit includes a third layer of release film, a second disinfection pad is removable from the disinfection unit and used to disinfect the connector. In alternative designs in which the disinfection unit includes a cap, the cap including the second disinfection pad can be removably secured to the connector after flushing so that the second disinfection pad contacts the connector. It can be understood that any known connecting engagement, such as a threaded engagement or a slip-fit ​​engagement, can be used to secure the cap to the connector.

[0016] According to yet another aspect, the present disclosure relates to a method for disinfecting a connector of an intravascular catheter, the method including providing a flush syringe configured to flush the intravascular catheter, the flush syringe including an integrated disinfection unit including at least a first antiseptic pad and a second antiseptic pad, the first antiseptic pad enclosed in a release film having a first layer and a second layer, and the second antiseptic pad enclosed in at least one of a second layer of release film, a third layer of release film, and a cap. The method further includes removing the first layer of release film and the first antiseptic pad, cleaning and disinfecting the connector with the first antiseptic pad before flushing the intravascular catheter, connecting the flush syringe to the connector and flushing the catheter line, disconnecting the flush syringe from the connector, removing the second layer of release film to expose the second antiseptic pad, and cleaning and disinfecting the connector with the second antiseptic pad after flushing.

[0017] In designs where the second antiseptic pad is enclosed within the second and third layers of release film, the method includes removing the second antiseptic pad from the disinfection unit to clean and disinfect the connector. In designs where the second antiseptic pad is enclosed within the second layer of release film and the cap, the method includes removably securing the cap to the connector such that the second antiseptic pad contacts the connector. [Brief explanation of the drawings]

[0018] The above and other features and advantages of the present disclosure, as well as the manner in which they are achieved, will become apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings. [Figure 1] FIG. 1 is a side perspective view of an intravascular catheter care device with an integrated disinfection unit, according to one embodiment of the present invention. [Figure 2A] 2A is a top perspective view of the disinfection unit of the intravascular catheter care device of FIG. 1 with the first layer of release film removed to reveal a first disinfection pad for pre-flush connector cleaning, according to one embodiment of the present invention. [Figure 2B] FIG. 2B is a top perspective view of the sterilization unit of FIG. 2A with the first sterilization pad removed, according to one embodiment of the present invention. [Figure 2C] FIG. 2C is a top perspective view of the sterilization unit of FIG. 2B prior to removal of the second layer of release film covering the second sterilization pad, according to one embodiment of the present invention. [Figure 2D] FIG. 2D is a top perspective view of the sterilization unit of FIG. 2C with the second layer of release film removed to reveal a second sterilization pad for post-flush connector cleaning, according to one embodiment of the present invention. [Figure 3] FIG. 3 is a side perspective view of an intravascular catheter care device with an integrated disinfection unit, according to one embodiment of the present invention. [Figure 4A] 4A is a top perspective view of the disinfection unit of the intravascular catheter care device of FIG. 3 with the first layer of release film removed to reveal a first disinfection pad for pre-flush connector cleaning, according to one embodiment of the present invention. [Figure 4B]FIG. 4B is a side perspective view of the cap from the disinfection unit of FIG. 4A with the first and second release layers removed to show a second disinfection pad / cap configuration for attachment to a connector for post-flush connector cleaning, according to one embodiment of the present invention.

[0019] Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set forth herein illustrate exemplary embodiments of the present disclosure, and such exemplifications should not be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE INVENTION

[0020] Except in the operating examples or where otherwise indicated, all numbers expressing quantities of components, material properties, and the like used in the specification and claims, as well as the drawings, should be understood to be modified in all instances by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the following specification and appended claims are approximations that may vary depending upon the desired properties to be obtained by the present invention. At the very least, and not as an attempt to limit the scope of the claims by the application of the doctrine of equivalents, each numerical parameter should at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0021] Notwithstanding that the numerical ranges and parameters setting forth the broad scope of the invention are approximations, the numerical values ​​set forth in the specific examples are reported as precisely as possible. However, any numerical value inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Furthermore, when numerical ranges of various scopes are set forth herein, it is contemplated that any combination of these values ​​inclusive of the recited values ​​may be used.

[0022] Hereinafter, for purposes of explanation, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "transverse," "longitudinal," and their derivatives will refer to the present invention as oriented in the drawings. However, it will be understood that the present invention may assume various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the present invention. Hence, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered limiting.

[0023] In the following description, "distal" refers to the direction toward the end of the syringe assembly adapted for patient contact and / or engagement with a separate device, such as a needle assembly or an IV connection assembly, and "proximal" refers to the opposite direction of distal, i.e., the direction away from the end of the syringe assembly adapted for engagement with a separate device. For purposes of this disclosure, the above references are used in describing the components of a syringe assembly according to the present disclosure.

[0024] Reference is now made to FIGS. 1 and 2A-2D, which illustrate an intravascular catheter care device, generally designated 10, having an integrated disinfection unit 12 according to one embodiment of the present invention. The intravascular catheter care device 10 includes a flush syringe 14 having a distal tip 16 configured to connect to a connector of an intravascular catheter (not shown) for flushing the intravascular catheter. The syringe 14 may be any well-known syringe having a barrel 18 for containing a flushing fluid, such as saline, and a plunger rod 20 at its proximal end 22 for dispensing the flushing fluid. While the figures and description refer to a flushing syringe, it can be understood that the disinfection device of the present disclosure may be integrated with any device connected to a connector of an intravascular catheter, such as for injecting medications or withdrawing fluids, to ensure proper disinfection of the connector before and after use of the device with an intravascular device. The disinfection unit 12 is associated with the flush syringe, such as by being removably secured to the distal tip 16 of the flush syringe 14. It can be appreciated that the sterilization unit 12 can be secured to the flush syringe 14 by any known means, such as pressure or temperature sensitive adhesives, mechanical attachment, thermoforming or injection molding with frangible portions, etc. In another embodiment, the sterilization unit 12 is packaged with the flush syringe 14 rather than being physically attached to the flush syringe 14.

[0025] The sanitizing unit 12 includes a first sanitizing pad 30 enclosed within a flexible release film, generally designated as 32. The release film 32 includes a first layer 34 and a second layer 36. The first layer 32 is configured to be detached from the second layer 34 to expose the first sanitizing pad 30, as shown in FIG. 2A. The release film 32 may have a gripping portion 37 for easily removing the first layer 34 from the second layer 36.

[0026] Reference is now made to FIGS. 2B-2D, which illustrate a second antiseptic pad 40. The second antiseptic pad is enclosed between a second layer 36 of release film 32 and at least one third layer 42 of release film 32. As shown in FIGS. 2A-2D, a seal line 38 secures the second layer 36 to the third layer 42. The second layer 36 is configured to be detachable from the third layer 42 to expose the second antiseptic pad 40. It can be appreciated that the first antiseptic pad 30 is removable from the antiseptic unit 12 for pre-flush cleaning of the connector of the intravascular catheter, and the second antiseptic pad 40 is removable from the antiseptic unit 12 for post-flush cleaning of the connector of the intravascular catheter.

[0027] The first and second antiseptic pads 30, 40 may contain an antibacterial composition that is effective in preventing pathogen growth and colonization and is safe for use in infusion systems. Antibacterial compositions according to the present invention generally contain antibacterial or biocide agents that are effective against various forms and strains of bacteria that can cause infection in patients. According to one embodiment, the antiseptic solution may include a 70% aqueous isopropyl alcohol solution, although any known antibacterial or biocide disinfectant may be used. The first and second antiseptic pads 30, 40 may be made of either a nonwoven material or a foam made from a polymer such as polyurethane, polyethylene, or polystyrene, but are not limited to these. The first and second antiseptic pads 30, 40 may be patterned, as shown at 31, 41, for better scrubbing efficiency.

[0028] 3 and 4A-4B, an intravascular catheter care device, generally designated 100, having an integrated disinfection unit 112 according to another design of the present invention is shown. The intravascular catheter care device 100 includes a flush syringe 114 having a distal tip 116 configured to connect to a connector of an intravascular catheter (not shown) for flushing the intravascular catheter. The syringe 114 may be any known syringe having a barrel 118 for containing a flushing fluid, such as saline, and a plunger rod 120 at a proximal end 122 for dispensing the flushing fluid. The disinfection unit 112 is associated with the flush syringe 114, such as by being removably secured to the distal tip 116 of the flushing syringe 114. The disinfection unit 112 includes a first disinfection pad 130 enclosed within a flexible release film, generally designated 132. The release film 132 includes a first layer 134 and a second layer 136. 4A, the first layer 134 is configured to be detached from the second layer 136 to expose the first antiseptic pad 130. The release film 132 can have a gripping portion 137 for easily removing the first layer 134 from the second layer 136.

[0029] Reference is now made to FIG. 4B, which illustrates the second antiseptic pad 140. A cap 150 is provided to hold the second antiseptic pad 140. The cap 150 is removably secured to the distal tip 116 of the flush syringe 114. A second layer 136 of the release film 132 is secured to an end 152 of the cap 150 via a seal line 138. This second layer 136 can be removed from the edge 152 of the cap 150 to expose the second antiseptic pad 140. The cap 150 can then be removably secured to the connector after flushing such that the second antiseptic pad 140 contacts the connector. It can be appreciated that the cap 150 can be secured to the connector by any known engagement, such as a threaded engagement, a friction fit, or a slip fit engagement.

[0030] The first and second antiseptic pads 130, 140 may contain an antimicrobial composition that is effective in preventing pathogen growth and colonization and is safe for use in infusion systems. According to one embodiment, the antiseptic solution may include a 70% aqueous isopropyl alcohol solution, although any known antibacterial or biocide disinfectant may be used. The first and second antiseptic pads 130, 140 may be made of either a nonwoven material or a foam made from a polymer such as polyurethane, polyethylene, or polystyrene, but are not limited to such. The first and second antiseptic pads 130, 140 may be patterned, as indicated by 131, 141, for better scrubbing efficiency.

[0031] The release films 32, 132 can be formed from any well-known release film layer, such as, for example, an aluminum release backing layer including a plastic sealed aluminum, which can be chemically resistant, light-tight, impermeable, and sterile.

[0032] 1, 2A-2D, along with FIG. 3 and FIG. 4A-4B, a method for disinfecting a connector of an intravascular catheter with an intravascular catheter care device 10, 100 of the present invention includes providing a flush syringe 14, 114 configured to flush an intravascular catheter with an integrated disinfection unit 12, 112. The disinfection unit 12, 112 includes at least a first disinfection pad 30, 130 and a second disinfection pad 40, 140. The first disinfection pad 30, 130 is enclosed within a release film 32, 132 having a first layer 34, 134 and a second layer 36, 136. The second disinfection pad 40, 140 is enclosed within the second layer 36, 136 of the release film 32, 132 and at least one of the third layer 42 of the release film 32, 132 or a cap 150. The method further includes removing the first layer 34, 134 of the release film 32, 132 and removing the first antiseptic pad 30, 130; using the first antiseptic pad 30, 130 to clean and disinfect the connector of the intravascular catheter before flushing or pre-flushing; connecting a flush syringe 14, 114 to the connector and flushing the catheter line; disconnecting the flush syringe 14, 114 from the connector; removing the second layer 36, 136 of the release film 32, 132 to expose the second antiseptic pad 40, 140; and using the second antiseptic pad 40, 140 to clean and disinfect the connector after flushing. 1 and 2A-2D, the second antiseptic pad 40 is enclosed within the second layer 36 of the release film 32, 132 and the third layer 42 of the release film, and the method includes removing the second antiseptic pad 40 from the antiseptic unit 12, 112 to clean and disinfect the connector. In the design of FIGS. 3 and 4A-4B, the second antiseptic pad 140 is placed within the cap 150 and sealed by the second layer 136 of the release film 132. The method includes removing the second layer 136 to expose the second antiseptic pad 140 and securing the cap 150 to the connector such that the second antiseptic pad 140 contacts the connector.

[0033] While this disclosure has been described as having exemplary structures, the disclosure can be further modified within the spirit and scope of the disclosure. Accordingly, this application is intended to cover any variations, uses, or adaptations of the disclosure using its general principles. Further, this application is intended to cover such departures from the disclosure as come within known or customary practice in the art to which this disclosure pertains and fall within the scope of the appended claims.

Claims

1. 1. An intravascular catheter care device comprising: a flush syringe configured to flush the intravascular catheter; a disinfection unit associated with the flush syringe, the disinfection unit including at least a first disinfection pad enclosed within a flexible release film, the release film including a first layer and a second layer, the first layer configured to be removed from the second layer to expose the first disinfection pad, the first disinfection pad being removable from the disinfection unit for at least one of pre-flush or post-flush cleaning of a connector of the intravascular catheter; A device comprising:

2. 10. The device of claim 1, wherein the first antiseptic pad has a patterned surface configured to increase the scrubbing and disinfecting efficiency of the pad.

3. 10. The device of claim 1, wherein the first antiseptic pad is used for pre-flush, and the antiseptic unit further comprises a second antiseptic pad configured for post-flush cleaning of the connector of the intravascular catheter.

4. 4. The device of claim 3, wherein the second layer of the release film separates the first antiseptic pad from the second antiseptic pad, the second layer being configured to be removed from the first layer to expose the second antiseptic pad.

5. 5. The device of claim 4, wherein the release film includes a third layer, and the second antiseptic pad is enclosed between the second layer and the third layer.

6. 5. The device of claim 4, wherein the disinfecting unit includes a cap, the second disinfecting pad is disposed within the cap, and the second layer forms a seal with the cap to seal the second disinfecting pad therein.

7. 7. The device of claim 6, wherein the cap containing the second antiseptic pad is configured to be removably secured to the connector post-flushing such that the second antiseptic pad contacts the connector.

8. The device of claim 1 , wherein the first antiseptic pad is soaked in an antiseptic solution.

9. 4. The device of claim 3, wherein the second antiseptic pad has a patterned surface and is soaked in an antiseptic solution.

10. 1. An intravascular catheter care device comprising: a flush syringe configured to flush the intravascular catheter; A disinfection unit associated with the flush syringe, the disinfection unit comprising: at least a first antiseptic pad enclosed within a flexible release film, the release film including a first layer and a second layer, the first layer configured to be removed from the second layer to expose the first antiseptic pad; at least a second antiseptic pad, the second antiseptic pad being enclosed between the second layer of the release film and at least one of a third layer of the release film and a cap, the second layer being configured to be removed from at least one of the third layer and the cap to expose the second antiseptic pad; Including, The device, wherein the first antiseptic pad is removable from the antiseptic unit for pre-flush cleaning of the connector of the intravascular catheter, and the second antiseptic pad is usable for post-flush cleaning of the connector of the intravascular catheter.

11. 11. The device of claim 10, wherein the first and second antiseptic pads have patterned surfaces configured to increase the scrubbing and disinfecting efficiency of the pads.

12. 11. The device of claim 10, wherein the first and second antiseptic pads are soaked in an antiseptic solution.

13. 11. The device of claim 10, wherein the disinfection unit includes the third layer of the release film and the second disinfection pad is removable from the disinfection unit.

14. 11. The device of claim 10, wherein the disinfection unit includes the cap, and the cap including the second disinfection pad is configured to be removably secured to the connector post-flushing such that the second disinfection pad contacts the connector.

15. 1. A method for disinfecting a connector of an intravascular catheter, comprising: providing a flush syringe configured to flush the intravascular catheter, the flush syringe including an integrated antiseptic unit including at least a first antiseptic pad and a second antiseptic pad, the first antiseptic pad enclosed within a release film having a first layer and a second layer, and the second antiseptic pad enclosed within the second layer of release film and at least one of a third layer of release film, a third layer, or a cap; removing the first layer of the release film and removing the first antiseptic pad; cleaning and disinfecting the connector of the intravascular catheter with the first antiseptic pad before flushing; connecting the flush syringe to the connector and flushing the catheter line; removing the flush syringe from the connector; removing the second layer of the release film to expose the second antiseptic pad; After rinsing, cleaning and disinfecting the connector with the second disinfecting pad; A method comprising:

16. 16. The method of claim 15, wherein the second antiseptic pad is enclosed within the second and third layers of the release film, the method including removing the second antiseptic pad from the antiseptic unit for cleaning and disinfecting the connector.

17. 16. The method of claim 15, wherein the second antiseptic pad is enclosed within the second layer of the release film and the cap, the method including the step of removably securing the cap to the connector such that the second antiseptic pad contacts the connector.

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