Intravascular catheter care before and after irrigation

Abstract

An endovascular catheter care device and a method for disinfecting an endovascular catheter, the device including an irrigation syringe having an integrated disinfection unit associated therewith, where the disinfection unit includes a first disinfection pad encapsulated between first and second layers of a flexible release film. The first layer may be removed from the second layer to expose the first sanitizing pad. The second sterilisation pad may be encapsulated between the second layer of release film and the third layer of release film, or between the second layer of release film and a cap that may be secured to the connector. The second layer may be removed from the third layer or cap to expose the second sanitizing pad. The first pad may be used to sterilize a connector of an intravascular catheter prior to irrigation, while the second pad may be used after irrigation.

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Utility Application No. 17 / 989,306, filed on November 17, 2022, entitled "Intravascular Catheter Care Before and After Flushing", the entire disclosure of which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present disclosure generally relates to the care of catheter devices. More particularly, the present disclosure relates to an integrated intravascular catheter cleaning and disinfection device for disinfecting the connectors of a catheter before and after catheter flushing. Background Art

[0004] Intravascular catheter care and practice standards generally recommend flushing procedures after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, blood transfusion, and parenteral nutrition. The purpose of these flushing procedures is to confirm catheter patency, avoid drug incompatibility, ensure complete drug dose administration, prevent thrombosis, and minimize the risk of bloodstream infection.

[0005] Catheter - related bloodstream infections are common in patients with intravascular (IV) catheters and are caused by bacteria / fungi. These infections can lead to serious illness, even death, and excessive medical costs. The currently recommended practice is for physicians to implement a step - by - step disinfection process. This process requires several disinfection steps, such as pre - flush disinfection and post - flush disinfection before injecting drugs or withdrawing fluids through the catheter port and the IV line, making intravascular catheter care and IV line maintenance a very burdensome and time - consuming process.

[0006] As a method of reducing these infections, protective caps or syringe collars containing disinfectants and / or antibacterial agents have been designed. As a method of reducing infections, these caps or collars can be associated with the outlet port of a flush syringe or with an IV port before connecting the flush syringe to the catheter port. However, these additional caps / collars can be difficult to manipulate or difficult to attach to the syringe or IV port, leading to operator error. In addition, using these caps / collars increases the total cost of the device, including due to an increased number of manufactured parts, increased packaging costs, and increased storage space due to the larger footprint of these caps / collars.

[0007] An IV connector cleaning device integrated with a flush syringe disinfects the connector before and after flushing in a cost - effective manner, which would be beneficial for reducing infections while reducing manufacturing and storage costs. Summary of the Invention

[0008] Accordingly, improved systems, devices, products, apparatuses, and / or methods are provided for performing intravascular catheter care and cleaning in a cost-effective manner, which have fewer manufacturing components and require less packaging and storage space.

[0009] In one aspect, the present disclosure relates to an intravascular catheter care device that includes a flush syringe configured to flush an intravascular catheter and a disinfection unit associated with the flush syringe. The disinfection unit may be attached to the flush syringe to enable a user to visually clean the connector prior to accessing the IV. According to one embodiment, the disinfection unit may be attached to the distal end of the flush syringe. According to another embodiment, the disinfection unit may be attached to the outer wall of the barrel of the flush syringe. The disinfection unit may be attached to the flush syringe by any known technique, including but not limited to using a pressure-sensitive or temperature-sensitive adhesive, mechanical attachment, thermoforming, or injection molding to attach to the flush syringe, and one or more frangible portions enabling removal of the disinfection unit from the flush syringe, etc.

[0010] In another embodiment, the disinfection unit may be co-packaged with the flush syringe rather than attaching the disinfection unit to the flush syringe itself.

[0011] The disinfection unit at least includes a first disinfection pad encapsulated within a flexible peelable film. The peelable film may include a first layer and a second layer, where the first layer is configured to be removed from the second layer to expose the first disinfection pad. The first disinfection pad may be removed from the disinfection unit for use in at least one of pre-flush cleaning or post-flush cleaning of the connector of the intravascular catheter. The remaining components of the disinfection unit may be reserved for future use. The first disinfection pad may have a patterned surface configured to enhance the scrubbing and disinfection efficiency of the pad and the first disinfection pad may be formed of a woven material or a foam material. The first disinfection pad may be soaked in any known disinfecting or antibacterial material, such as, for example, a 70% aqueous solution of isopropyl alcohol.

[0012] According to one embodiment, a first disinfection pad can be used before flushing, and the disinfection unit can further include a second disinfection pad configured to clean the connector of the intravascular catheter after flushing. A second layer of the release film can separate the first disinfection pad from the second disinfection pad, and the second layer can be configured to be removed from the first layer to expose the second disinfection pad. According to one design, the release film can include a third layer, and the second disinfection pad is encapsulated between the second layer and the third layer. According to another design, the disinfection unit can include a cap, the second disinfection pad is located within the cap, and the second layer forms a seal with the cap to encapsulate the second disinfection pad therein. The cap including the second disinfection pad can be configured to removably fix to the connector such that the second disinfection pad contacts the connector after flushing. It can be understood that the cap can be fixed to the connector by any known arrangement, such as by threaded engagement, slip fit engagement, etc.

[0013] Similar to the first disinfection pad, the second disinfection pad can have a patterned surface to improve the scrubbing and disinfection efficiency of the second disinfection pad and can be soaked with a known disinfection liquid.

[0014] According to another aspect, the present disclosure relates to an intravascular catheter care device including a flushing syringe configured to flush an intravascular catheter and a disinfection unit associated with the flushing syringe. The disinfection unit can at least include a first disinfection pad encapsulated within a flexible release film. The release film includes a first layer and a second layer, wherein the first layer is configured to be removed from the second layer to expose the first disinfection pad. The disinfection unit can further at least include a second disinfection pad, wherein the second disinfection pad is encapsulated between the second layer and the third layer of the release film or encapsulated between the second layer of the release film and a cap. The second layer is configured to be removed from the third layer or the cap to expose the second disinfection pad. The first disinfection pad can be removed from the disinfection unit to enable a user to disinfect the connector of the intravascular catheter before or during flushing, and the second disinfection pad can be used to disinfect the intravascular catheter after or following flushing.

[0015] The first disinfection pad and the second disinfection pad can have a patterned surface configured to improve the scrubbing and disinfection efficiency of the first disinfection pad and the second disinfection pad. According to one embodiment, the first disinfection pad and the second disinfection pad can be soaked in a disinfection solution. It can be understood that any known disinfection or antibacterial material can be used to soak the first disinfection pad and the second disinfection pad. An example of a disinfection material that can be used includes an aqueous solution of 70% isopropyl alcohol.

[0016] In a design where the disinfection unit includes a third layer of release film, the second disinfection pad can be removed from the disinfection unit and used to disinfect the connector. In an alternative design where the disinfection unit includes a cap, the cap including the second disinfection pad can be removably fixed to the rinsed connector such that the second disinfection pad contacts the connector. It will be appreciated that any known connection engagement (e.g., threaded engagement or slip fit engagement) can be used to fix the cap to the connector.

[0017] According to yet another aspect, the present disclosure relates to a method for disinfecting a connector of an intravascular catheter, the method comprising providing a rinsing syringe configured to rinse an intravascular catheter, the rinsing syringe including an integrated disinfection unit that at least includes a first disinfection pad and a second disinfection pad, wherein the first disinfection pad is encapsulated within a release film having a first layer and a second layer, and the second disinfection pad is encapsulated within at least one of a third layer of the release film and a cap and a second layer of the release film. The method further comprises: removing the first layer of the release film and removing the first disinfection pad; prior to rinsing the intravascular catheter, using the first disinfection pad to clean and disinfect the connector; connecting the rinsing syringe to the connector and rinsing the catheter line; and disconnecting the rinsing syringe from the connector; removing the second layer of the release film to expose the second disinfection pad; and after rinsing, using the second disinfection pad to clean and disinfect the connector.

[0018] In a design where the second disinfection pad is encapsulated within the second and third layers of the release film, the method includes removing the second disinfection pad from the disinfection unit for cleaning and disinfecting the connector. In a design where the second disinfection pad is encapsulated within the second layer of the release film and the cap, the method includes removably fixing the cap to the connector such that the second disinfection pad contacts the connector. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The above and other features and advantages of the present disclosure, and the manner of realizing them, will become more apparent and the present disclosure itself will be better understood by reference to the following description of embodiments of the present disclosure in conjunction with the accompanying drawings, in which:

[0020] Figure 1 is a side perspective view of an intravascular catheter care device having an integrated disinfection unit according to an embodiment of the present invention.

[0021] Figure 2A is according to an embodiment of the present invention Figure 1 a top perspective view of the disinfection unit of the intravascular catheter care device, in which the first layer of the release film is removed to show the first disinfection pad for pre-rinsing connector cleaning.

[0022] Figure 2B is according to an embodiment of the present invention Figure 2ATop perspective view of the disinfection unit, where the first disinfection pad is removed.

[0023] Figure 2C is according to an embodiment of the present invention Figure 2B Top perspective view of the disinfection unit before removing the second layer covering the second disinfection pad of the release film.

[0024] Figure 2D is according to an embodiment of the present invention Figure 2C Top perspective view of the disinfection unit, where the second layer of the release film is removed to show the second disinfection pad for post - flush connector cleaning.

[0025] Figure 3 Side perspective side view of an intravascular catheter care device with an integrated disinfection unit according to an embodiment of the present invention.

[0026] Figure 4A is according to an embodiment of the present invention Figure 3 Top perspective view of the disinfection unit of the intravascular catheter care device, where the first layer of the release film is removed to show the first disinfection pad for pre - flush connector cleaning.

[0027] Figure 4B is according to an embodiment of the present invention Figure 4A Side perspective view of the cap of the disinfection unit, where the first and second release layers are removed to show the second disinfection pad / cap arrangement for attachment to the connector for post - flush connector cleaning

[0028] In several views, corresponding reference numerals refer to corresponding components. The examples set forth herein illustrate exemplary embodiments of the present disclosure, and these examples should not be construed as limiting the scope of the present disclosure in any way. Detailed Description

[0029] Unless otherwise indicated by an operation example or otherwise, all numbers representing amounts of ingredients, material properties, etc. used in this specification, claims, and drawings should be understood to be modified by the term "about" in all cases. Accordingly, unless otherwise indicated, the numerical parameters set forth in the following specification and attached claims are approximations, which may vary depending on the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits reported and by applying ordinary rounding techniques.

[0030] While 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. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Moreover, when numerical ranges of varying scope are set forth herein, it is contemplated that any combination of these values, including the recited values, may be used.

[0031] In the following discussion, for purposes of description, the terms "upper", "lower", "right", "left", "vertical", "horizontal", "top", "bottom", "lateral", "longitudinal", and derivatives thereof shall relate to the orientation of the invention in the drawings. However, it is to be understood that the invention may assume various alternative variations, unless expressly specified to the contrary. It is also to be understood that the specific devices shown in the drawings and described in the following specification are merely exemplary embodiments of the invention. Accordingly, specific dimensions and other physical characteristics relating to the embodiments disclosed herein are not to be considered as limiting.

[0032] In the following discussion, "distal" refers generally to the direction toward that end of the syringe assembly that is adapted to contact a patient and / or engage a separate device (such as a needle assembly or an IV connection assembly), while "proximal" refers to the direction opposite the distal direction, i.e., away from the end of the syringe assembly adapted to engage a separate device. For purposes of the present disclosure, the foregoing references are used when describing components of a syringe assembly in accordance with the present disclosure.

[0033] Now refer to Figure 1 and Figures 2A to 2D, which shows an intravascular catheter care device generally designated as 10 in accordance with an embodiment of the present invention. The intravascular catheter care device has an integrated disinfection unit 12. The intravascular catheter care device 10 includes a flush syringe 14 having a distal end 16 configured to connect to a connector (not shown) of an intravascular catheter for flushing the intravascular catheter. The syringe 14 can be any well-known syringe having a barrel 18 for containing a flush fluid (e.g., saline) and a plunger rod 20 for dispensing the flush fluid at a proximal end 22. Although the drawings and the specification relate to a flush syringe, it is understood that the disinfection device of the present disclosure can be integrated with any device to be connected to the connector of an intravascular catheter, such as for infusing drugs or withdrawing fluids, to ensure proper disinfection of the connector before and after using the device with the intravascular device. The disinfection unit 12 is associated with the flush syringe, for example, removably fixed to the distal end 16 of the flush syringe 14. It is understood that the disinfection unit 12 can be fixed to the flush syringe 14 by any well-known means, such as using a pressure-sensitive or temperature-sensitive adhesive, mechanical attachment, thermoforming, or injection molding, etc., by using a frangible portion. In another embodiment, the disinfection unit 12 is not physically attached to the flush syringe 14 but is co-packaged with the flush syringe 14.

[0034] The disinfection unit 12 includes a first disinfection pad 30 encapsulated within a flexible peelable film (generally labeled 32). The peelable film 32 includes a first layer 34 and a second layer 36. As Figure 2A shown, the first layer 32 is configured to be removed from the second layer 34 to expose the first disinfection pad 30. The peelable film 32 can have a grip portion 37 for easily removing the first layer 34 from the second layer 36.

[0035] Now referring to Figures 2B to 2D , which shows a second disinfection pad 40. The second disinfection pad is encapsulated between the second layer 36 of the peelable film 32 and at least one third layer 42 of the peelable film 32. As Figures 2A to 2D shown, a seal line 38 secures the second layer 36 to the third layer 42. The second layer 36 is configured to be removed from the third layer 42 to expose the second disinfection pad 40. It is understood that the first disinfection pad 30 can be removed from the disinfection unit 12 for pre-flush cleaning of the connector of the intravascular catheter, and the second disinfection pad 40 can be removed from the disinfection unit 12 for post-flush cleaning of the connector of the intravascular catheter.

[0036] The first disinfection pad 30 and the second disinfection pad 40 may comprise an antibacterial composition that is effective in preventing the growth and colonization of pathogens and is safe for use in an infusion system. The antibacterial composition according to the present invention generally comprises an antibacterial agent or bactericide that is effective against various forms and strains of bacteria that may cause infection in a patient. According to one embodiment, the disinfection liquid may comprise 70% aqueous isopropyl alcohol; however, any known antibacterial agent or bactericide may be used. The first disinfection pad 30 and the second disinfection pad 40 may be made of either a non-woven material or a foam, the non-woven material or the foam being made of a polymer (such as, but not limited to, polyurethane, polyethylene, or polystyrene). As indicated by reference numerals 31, 41, the first disinfection pad 30 and the second disinfection pad 40 may be patterned to enhance the scrubbing efficiency.

[0037] Now referring to Figure 3 and Figures 4A to 4B , which shows an intravascular catheter care device (generally labeled 100) according to another design of the present invention, the intravascular catheter care device having an integrated disinfection unit 112. The intravascular catheter care device 100 includes a flush syringe 114 having a distal end 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 flush fluid (such as, saline) and a plunger rod 120 for dispensing the flush fluid at a proximal end 122. The disinfection unit 112 is associated with the flush syringe 114, for example, removably fixed to the distal end 116 of the flush syringe 114. The disinfection unit 112 includes a first disinfection pad 130 encapsulated within a flexible peelable membrane (generally labeled 132). The peelable membrane 132 includes a first layer 134 and a second layer 136. As Figure 4A shown, the first layer 134 is configured to be removed from the second layer 136 to expose the first disinfection pad 130. The peelable membrane 132 may have a gripping portion 137 for easily removing the first layer 134 from the second layer 136.

[0038] Now referring to Figure 4B, which shows the second disinfection pad 140. A cap 150 is provided for holding the second disinfection pad 140. The cap 150 is removably fixed to the distal end 116 of the irrigation syringe 114. The second layer 136 of the release film 132 is fixed to the edge 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 disinfection pad 140. Then, the cap 150 can be removably fixed to the rinsed connector such that the second disinfection pad 140 contacts the connector. It will be appreciated that the cap 150 can be fixed to the connector by any known joining means, such as by threaded engagement, friction fit or slip fit engagement, etc.

[0039] The first disinfection pad 130 and the second disinfection pad 140 may include an antimicrobial composition that is effective in preventing the growth and colonization of pathogens and is safe for use in an infusion system. According to one embodiment, the disinfection liquid may include 70% aqueous isopropyl alcohol; however, any known antimicrobial or bactericidal disinfectant can be used. The first disinfection pad 130 and the second disinfection pad 140 can be made of either a non-woven material or a foam, which is made of a polymer such as, but not limited to, polyurethane, polyethylene or polystyrene. As shown by reference numerals 131, 141, the first disinfection pad 130 and the second disinfection pad 140 can be patterned to improve the scrubbing efficiency.

[0040] The release films 32, 132 can be formed of any known release film layer, such as, for example, an aluminum release backing layer including a plastic seal aluminum, which can be chemical resistant, light blocking, impermeable and sterile.

[0041] Return reference Figure 1 , Figures 2A to 2D and Figure 3 and Figures 4A to 4B, A method for disinfecting a connector of an intravascular catheter using the intravascular catheter care devices 10, 100 of the present invention includes providing a flush syringe 14, 114 with an integrated disinfection unit 12, 112, the flush syringe being configured to flush the intravascular catheter. 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 encapsulated 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 encapsulated within at least one of a third layer 42 of the release film 32, 132 or a cap 150 and the second layer 36, 136 of the release film 32, 132. The method further includes: removing the first layer 34, 134 of the release film 32, 132 and removing the first disinfection pad 30, 130; cleaning and disinfecting the connector of the intravascular catheter with the first disinfection pad 30, 130 before or during flushing; connecting the 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 disinfection pad 40, 140; and cleaning and disinfecting the connector with the second disinfection pad 40, 140 after flushing. In Figure 1 and Figures 2A to 2D designs, the second disinfection pad 40 is encapsulated 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 disinfection pad 40 from the disinfection unit 12, 112 for cleaning and disinfecting the connector. In Figure 3 and Figures 4A to 4B designs, the second disinfection 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 disinfection pad 140 and securing the cap 150 to the connector such that the second disinfection pad 140 contacts the connector.

[0042] Although the present disclosure has been described as having an exemplary design, the present disclosure may be further modified within the spirit and scope of the present disclosure. Accordingly, this application is intended to cover any variations, uses, or modifications of the present disclosure using its general principles. Additionally, 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 limits of the appended claims.

Claims

1. An intravascular catheter care device, the 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 including at least a first disinfection pad encapsulated in a flexible release film, the release film including a first layer and a second layer, wherein the first layer is configured to be removed from the second layer to expose the first disinfection pad, and wherein the first disinfection pad is removable from the disinfection unit for at least one of pre-flush cleaning or post-flush cleaning of a connector of the intravascular catheter.

2. The device according to claim 1, wherein The first disinfection pad has a patterned surface configured to enhance the scrubbing and disinfection efficiency of the pad.

3. The device according to claim 1, wherein The first disinfection pad is for use before flushing, and wherein the disinfection unit further includes a second disinfection pad configured for post-flush cleaning of the connector of the intravascular catheter.

4. The apparatus according to claim 3, wherein, The second layer of the release film separates the first disinfection pad from the second disinfection pad, and wherein the second layer is configured to be removed from the first layer to expose the second disinfection pad.

5. The apparatus according to claim 4, wherein, The release film includes a third layer, and wherein the second disinfection pad is encapsulated between the second layer and the third layer.

6. The device according to claim 4, wherein, The disinfection unit includes a cap, wherein The second disinfection pad is located within the cap and the second layer forms a seal with the cap to encapsulate the second disinfection pad therein.

7. The apparatus according to claim 6, wherein, The cap including the second disinfection pad is configured to be removably fixed to the connector after flushing such that the second disinfection pad contacts the connector.

8. The device according to claim 1, wherein, The first disinfection pad is soaked with a disinfection liquid.

9. The device according to claim 3, wherein The second disinfection pad has a patterned surface and is soaked with a disinfection liquid.

10. An intravascular catheter care device, the intravascular catheter care device comprising: A flush syringe configured to flush the intravascular catheter; And A disinfection unit associated with the flush syringe, the disinfection unit including: At least a first disinfection pad encapsulated in a flexible release film, the release film including a first layer and a second layer, wherein the first layer is configured to be removed from the second layer to expose the first disinfection pad; At least a second disinfection pad, wherein the second disinfection pad is encapsulated between at least one of a cap and a third layer of the release film and the second layer of the release film, wherein the second layer is configured to be removed from at least one of the third layer and the cap to expose the second disinfection pad, Wherein the first disinfection pad is removable from the disinfection unit for pre-flush cleaning of a connector of the intravascular catheter, and the second disinfection pad can be used for post-flush cleaning of the connector of the intravascular catheter.

11. The apparatus according to claim 10, wherein, The first disinfection pad and the second disinfection pad have patterned surfaces configured to enhance the scrubbing and disinfection efficiency of the pads.

12. The device according to claim 10, wherein, The first disinfection pad and the second disinfection pad are soaked in a disinfection solution.

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

14. The device according to claim 10, wherein, The disinfection unit includes the cap, and wherein the cap including the second disinfection pad is configured to be removably fixed to the connector after flushing such that the second disinfection pad contacts the connector.

15. A method for disinfecting a connector of an intravascular catheter, the method comprising: Providing a flushing syringe configured to flush the intravascular catheter, the flushing syringe including an integrated disinfection unit that at least includes a first disinfection pad and a second disinfection pad, wherein the first disinfection pad is encapsulated within a release film having a first layer and a second layer, and the second disinfection pad is encapsulated within at least one of a cap or the third layer of the release film and the second layer of the release film; Removing the first layer of the release film and removing the first disinfection pad; Before flushing, using the first disinfection pad to clean and disinfect the connector of the intravascular catheter; Connecting the flushing syringe to the connector and flushing the catheter line; Disconnecting the flushing syringe from the connector; Removing the second layer of the release film to expose the second disinfection pad; and After flushing, using the second disinfection pad to clean and disinfect the connector.

16. The method according to claim 15, wherein, The second disinfection pad is encapsulated within the second and third layers of the release film, and wherein the method includes removing the second disinfection pad from the disinfection unit for cleaning and disinfecting the connector.

17. The method according to claim 15, wherein, The second disinfection pad is encapsulated within the cap and the second layer of the release film, and wherein the method includes removably fixing the cap to the connector such that the second disinfection pad contacts the connector.

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