Patent Application
20240165320
The present disclosure relates generally to the care of a catheter device. More particularly, the present disclosure relates to an integrated intravascular catheter cleaning and disinfecting device for use in disinfecting a connector of the catheter pre-flushing and post-flushing of the catheter.
Intravascular catheter care and standards of practice usually recommend that flush procedures be performed after catheter placement, before fluid infusion, and before and after drug administration, blood sampling, transfusions, and parenteral nutrition. The goal of these flush procedures is to confirm catheter patency, avoid drug incompatibilities, ensure complete drug dose administration, prevent thrombus formation, and minimize the risk of blood stream infections.
Catheter-related bloodstream infections are common and are caused by bacterial/fungi in patients with intravascular (IV) catheters. These infections can result in significant illness, or even death, as well as, excess medical costs. Current recommended practice is for the medical practitioner to perform a stepwise disinfecting process. This process requires several disinfecting steps, such as pre-flushing and post-flushing, prior to medication push or fluid withdrawal through the catheter port and IV line, which makes intravascular catheter care and IV line maintenance a very burdensome and time consuming process.
Protective caps or syringe collars containing disinfectants and/or antimicrobial agents therein have been designed as a way to reduce these infections. These caps or collars can be associated with an exit port of a flush syringe or with an IV port prior to connection of the flush syringe with the catheter port as a way to reduce infections. However, these additional caps/collars may be difficult to manipulate or attach to the syringe or IV port, resulting in an operator error. Additionally, 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.
An IV connector cleaning device that is integrated with the flush syringe to disinfect the connector, pre-flushing and post-flushing, in a cost-effective manner would be beneficial in reducing infections while decreasing manufacturing and storage costs.
Accordingly, provided are improved systems, devices, products, apparatus, and/or methods for intravascular catheter care and cleaning in a cost-effective manner having less manufactured components and require less packaging and storage space.
In accordance with an aspect, the present disclosure is directed to an intravascular catheter care device comprising a flush syringe configured for flushing an intravascular catheter and a disinfecting unit associated with the flush syringe. The disinfecting unit can be attached to the flush syringe, making it intuitive for the user to clean the connector before IV access. According to one embodiment, the disinfecting unit can be attached to the distal tip of the flush syringe. According to another embodiment, the disinfecting unit can be attached to the outer wall of the barrel of the flush syringe. The disinfecting units can be attached to the flush syringe by any well-known technique, including, but not limited to, the use of pressure or temperature sensitive adhesive, mechanical attachment, thermoforming or injection molding with one or more frangible portions enabling the removal of the disinfecting unit from the flush syringe, and the like.
In another embodiment, instead of attaching the disinfecting unit to the flush syringe itself, the disinfecting unit can be co-packaged with the flush syringe.
The disinfecting unit comprises at least a first disinfecting pad enclosed within a flexible peel film. The peel film can include a first layer and a second layer, wherein the first layer is configured for removal from the second layer to expose the first disinfecting pad. The first disinfecting pad is removable from the disinfecting unit for one or pre-flush or post-flush cleaning of a connector of the intravascular catheter. The remaining components of the disinfecting unit can be set aside for future use. The first disinfecting pad can have a patterned surface configured for increasing scrubbing and disinfecting efficiency of the pad and can be formed from a woven or a foam material. The first disinfecting pad can be soaked in any well-known disinfecting or antimicrobial material, such as, for example, a 70% aqueous isopropyl alcohol solution.
According to one embodiment, the first disinfecting pad can be used pre-flushing and the disinfecting unit can further comprise a second disinfecting pad configured for cleaning of the connector of the intravascular catheter post-flushing. The second layer of the peel film can separate the first disinfecting pad from the second disinfecting pad and the second layer can be configured for the removal from the first layer to expose the second disinfecting pad. According to one design, the peel film can comprise a third layer and the second disinfecting pad is enclosed between the second layer and the third layer. According to another design, the disinfecting unit can comprise a cap and the second disinfecting pad is located within the cap and the second layer forms a seal with the cap to enclose the second disinfecting pad therein. The cap, including the second disinfecting pad, can be configured to be removably secured onto the connector such that the second disinfecting pad comes into contact with the connector post-flushing. It can be appreciated that the cap can be secured to the connector by any well-known arrangement such as by a threaded engagement, slip fit engagement, and the like.
Similar to the first disinfecting pad, the second disinfecting pad can have a patterned surface to increase its scrubbing and disinfecting efficiency and can be soaked with a well-known disinfecting liquid.
In accordance with another aspect, the present disclosure is directed to an intravascular catheter care device comprising a flush syringe configured for flushing the intravascular catheter and a disinfecting unit associated with the flush syringe. The disinfecting unit can comprise at least a first disinfecting pad enclosed within a flexible peel film. The peel film includes a first layer and a second layer, wherein the first layer is configured for removal from the second layer to expose the first disinfecting pad. The disinfecting unit can further include at least a second disinfecting pad, wherein the second disinfecting pad is enclosed between either the second layer of the peel film and a third layer of the peel film or between a second layer of the peel film and a cap. The second layer is configured for the removal from either the third layer or the cap to expose the second disinfecting pad. The first disinfecting pad is removable from the disinfecting unit to enable a user to disinfect the connector of the intravascular catheter prior to flushing or pre-flushing and the second disinfecting pad is usable for disinfecting the intravascular catheter after flushing or post-flushing.
The first and second disinfecting pads can have a patterned surface configured for increasing the scrubbing and disinfecting efficiency of the pads. According to one embodiment, the first and second disinfecting pads can be soaked in a disinfecting solution. It can be appreciated that any well-known disinfecting or antimicrobial material can be used for soaking the first and second disinfecting pads. One example of a disinfecting material that can be used comprises a 70% aqueous isopropyl alcohol solution.
In the design where the disinfecting unit comprises the third layer of the peel film, the second disinfecting pad is removable from the disinfecting unit and is used to disinfect the connector. In the alternative design where the disinfecting unit comprises the cap, the cap including the second disinfecting pad can be removably secured onto the connector post-flushing such that the second disinfecting pad comes into contact with the connector. It can be appreciated that any well-known connection engagement can be used, such as a threaded or slip-fit engagement, to secure the cap onto the connector.
In accordance with yet another aspect, the present disclosure is directed to a method for disinfecting a connector of an intravascular catheter comprising providing a flush syringe configured for flushing the intravascular catheter, the flush syringe comprising an integrated disinfecting unit comprising at least a first disinfecting pad and a second disinfecting pad, wherein the first disinfecting pad is enclosed within a peel film having a first layer and a second layer and the second disinfecting pad is enclosed within the second layer of the peel film and at least one of a third layer of a peel film and a cap. The method further comprises removing the first layer of the peel film and removing the first disinfecting pad, cleaning and disinfecting a connector with the first disinfecting pad prior to flushing of the intravascular catheter, connecting the flush syringe to the connector and flushing the catheter line, and disconnecting the flush syringe from the connector, removing the second layer of the peel film to expose the second disinfecting pad, and cleaning and disinfecting the connector with the second disinfecting pad after flushing.
In the design where the second disinfecting pad is enclosed within the second layer of the peel film and the third layer, the method comprises removing the second disinfecting pad from the disinfecting unit for cleaning and disinfecting the connector. In the design where the second disinfecting pad is enclosed within the second layer of the peel film and the cap, the method comprises removably securing the cap onto the connector so that the second disinfecting pad comes into contact with the connector.
The above-mentioned and other features and advantages of this disclosure, and the manner of attaining them, will become more apparent and the disclosure itself will be better understood by reference to the following descriptions of embodiments of the disclosure taken in conjunction with the accompanying drawings, wherein:
Corresponding reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate exemplary embodiments of the disclosure, and such exemplifications are not to be construed as limiting the scope of the disclosure in any manner.
Other than in the operating examples, or where otherwise indicated, all numbers expressing quantities of ingredients, material properties, and so forth used in the specification and claims and Figures are to be understood as being modified in all instances by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon 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 at least be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.
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. Any numerical value, however, inherently contains certain errors necessarily resulting from the standard deviation found in their respective testing measurements. Furthermore, when numerical ranges of varying scope are set forth herein, it is contemplated that any combination of these values inclusive of the recited values may be used.
For purposes of the description hereinafter, the terms “upper”, “lower”, “right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”, “longitudinal”, and derivatives thereof shall relate to the invention as it is oriented in the drawing figures. However, it is to be understood that the invention may assume various alternative variations, except where expressly specified to the contrary. It is also to be understood that the specific devices illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments of the invention. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered as limiting.
In the following discussion, “distal” refers to a direction generally toward an end of a syringe assembly adapted for contact with a patient and/or engagement with a separate device such as a needle assembly or IV connection assembly, and “proximal” refers to the opposite direction of distal, i.e., away from the end of a syringe assembly adapted for engagement with the separate device. For purposes of this disclosure, the above-mentioned references are used in the description of the components of a syringe assembly in accordance with the present disclosure.
Reference is now made to
The disinfecting unit 12 includes a first disinfecting pad 30 enclosed within a flexible peel film, generally indicated as 32. The peel film 32 includes a first layer 34 and a second layer 36. The first layer 32 is configured for removal from the second layer 34 to expose the first disinfecting pad 30, as shown in
Reference is now made to
The first and second disinfecting pads 30, 40 may comprise an antimicrobial composition that is effective in preventing growth and colonization of pathogens, and that is safe for use in an infusion system. An antimicrobial composition in accordance with the present invention generally comprises an antimicrobial or biocidal agent effective against various forms and strains of bacteria which may cause infection within a patient. According to one embodiment, the disinfecting liquid can comprise a 70% aqueous isopropyl alcohol, however, any well-known antimicrobial or biocide disinfecting agent can be used. The first and second disinfecting pads 30, 40 can be made of either non-woven material or foam, made from polymers such as, but not limited to polyurethane, polyethylene, or polystyrene. The first and second disinfecting pads 30, 40 can be patterned, as shown by 31, 41 for better scrubbing efficiency.
Reference is now made to
Reference is now made to
The first and second disinfecting pads 130, 140 may comprise an antimicrobial composition that is effective in preventing growth and colonization of pathogens, and that is safe for use in an infusion system. According to one embodiment, the disinfecting liquid can comprise a 70% aqueous isopropyl alcohol, however, any well-known antimicrobial or biocide disinfecting agent can be used. The first and second disinfecting pads 130, 140 can be made of either non-woven material or foam, made from polymers such as, but not limited to polyurethane, polyethylene, or polystyrene. The first and second disinfecting pads 130, 140 can be patterned, as shown by 131, 141 for better scrubbing efficiency.
The peel film 32, 132, can be formed from any well-known peel film layers, such as, for example, an aluminum peel back layers comprising a plastic sealed aluminum that can be chemically-resistant, light-blocking, non-permeable, and sterile.
Referring back to
While this disclosure has been described as having exemplary designs, the present disclosure can be further modified within the spirit and scope of this disclosure. This application is therefore 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 present disclosure as come within known or customary practice in the art to which this disclosure pertains and which fall within the limits of the appended claims.
