SANITIZING ARTICLES FOR LUER ACCESS DEVICES

Abstract

Single-use devices configured to sanitize accessible surfaces of luer access devices (e.g., needleless medical valves) at risk of contamination with infectious agents are described, as are methods for making and using such devices. In particularly preferred embodiments, such devices include a container (e.g., laminated foil pouches or packets) that contain a sanitizing component that includes a substrate with a cleaning port or recess, a cleansing matrix associated with the substrate, and a sanitizing reagent dispersed in the cleansing matrix.

Claims

1. A patentable single-use sanitizing article configured to sanitize a luer access device, optionally a needleless medical valve, or portion thereof, the article comprising: a. a container formed to provide a sealed internal cavity and adapted for manual opening; and b. disposed in the internal cavity of the container, a sanitizing component comprising: (i) a substrate comprising a cleaning port or recess; (ii) a cleansing matrix associated with the substrate and covering the cleaning port or recess; and (iii) a sanitizing reagent dispersed in the matrix, wherein the article optionally is sterile.

2. An article according to claim 1, wherein the cleansing matrix comprises an absorbent material selected from the group consisting of a naturally occurring material and a synthetic material, wherein when the substrate is a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the substrate is a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel.

3. An article according to claim 1, wherein the sanitizing reagent is a liquid formulation, optionally an aqueous solution, optionally a solution comprising an alcohol and water, optionally isopropyl alcohol and water, optionally 70% isopropyl alcohol and water.

4. An article according to claim 1, wherein the sanitizing reagent comprises one or more sanitizing compounds selected from the group consisting of an alcohol, chlorhexidine, hydrogen peroxide, iodine, silver ions, and a combination of any two or more of the foregoing.

5. An article according to claim 1, wherein the container comprises a laminated foil and further optionally comprises an access port sealingly covered by a cover removably adhered or attached to a portion of the container surrounding the access port that, when removed, allows access to the sanitizing component disposed in the internal cavity of the container.

6. An article according to claim 1, wherein an outer surface of the container is labeled.

7. A package comprising a plurality of articles according to claim 1.

8. A patentable method of sanitizing an accessible surface of a luer access device (optionally a needleless medical valve) comprising contacting an accessible surface of the luer access device (optionally a needleless medical valve) with a single-use sanitizing article according to claim 1 to sanitize the accessible surface, thereby sanitizing the accessible surface of the luer access device (optionally a needleless medical valve).

9. A method according to claim 8 wherein sanitizing of the accessible surface of the luer access device (optionally a needleless medical valve) results in at least a 10-fold reduction in microorganism contamination on the accessible surface, optionally more than a 100-fold, a 10.sup.3-fold, a 10.sup.4-fold, a 10.sup.5-fold, a 10.sup.6-fold, or 10.sup.7-fold reduction in microorganism contamination on the accessible surface.

10. A patentable method of reducing infection risk in a patient connected to a venous catheter having at least one luer access device (optionally a needleless medical valve), comprising contacting an accessible surface of a luer access device (optionally a needleless medical valve) of the venous catheter with a single-use sanitizing article according to claim 1 so as to sanitize the accessible surface of a luer access device (optionally a needleless medical valve), thereby reducing infection risk in the patient.

11. A patentable single-use sanitizing article configured to sanitize a luer access device, optionally a needleless medical valve, or portion thereof, the article comprising: a. a container formed to provide a sealed internal cavity, wherein the container comprises an access port sealingly covered by a cover removably adhered or attached to an exterior portion of the container surrounding the access port that, when removed, allows access to the internal cavity of the container; and b. disposed in the internal cavity of the container, a sanitizing component comprising: (i) a cleansing matrix associated with the substrate and covering cleaning port or recess; (ii) a sanitizing reagent dispersed in the matrix; and, optionally (iii) a substrate comprising a cleaning port or recess, wherein the article optionally is sterile.

12. An article according to claim 11, wherein the cleansing matrix comprises an absorbent material selected from the group consisting of a naturally occurring material and a synthetic material, wherein when the substrate is a naturally occurring material, the naturally occurring material is optionally a natural sponge, and wherein when the substrate is a synthetic material, the synthetic material is optionally selected from the group consisting of a fibrous composition, a foam, and a gel.

13. An article according to claim 11, wherein the sanitizing reagent is a liquid formulation, optionally an aqueous solution, optionally a solution comprising an alcohol and water, optionally isopropyl alcohol and water, optionally 70% isopropyl alcohol and water.

14. An article according to claim 11, wherein the sanitizing reagent comprises one or more sanitizing compounds selected from the group consisting of an alcohol, chlorhexidine, hydrogen peroxide, iodine, silver ions, and a combination of any two or more of the foregoing.

15. An article according to claim 11, wherein the container comprises a laminated foil.

16. An article according to claim 11, wherein an outer surface of the container is labeled.

17. A package comprising a plurality of articles according to claim 11.

18. A patentable method of sanitizing an accessible surface of a luer access device (optionally a needleless medical valve) comprising contacting an accessible surface of the luer access device (optionally a needleless medical valve) with a single-use sanitizing article according to claim 11 to sanitize the accessible surface, thereby sanitizing the accessible surface of the luer access device (optionally a needleless medical valve).

19. A method according to claim 18 wherein sanitizing of the accessible surface of the luer access device (optionally a needleless medical valve) results in at least a 10-fold reduction in microorganism contamination on the accessible surface, optionally more than a 100-fold, a 10.sup.3-fold, a 10.sup.4-fold, a 10.sup.5-fold, a 10.sup.6-fold, or 10.sup.7-fold reduction in microorganism contamination on the accessible surface.

20. A patentable method of reducing infection risk in a patient connected to a venous catheter having at least one luer access device (optionally a needleless medical valve), comprising contacting an accessible surface of a luer access device (optionally a needleless medical valve) of the venous catheter with a single-use sanitizing article according to claim 11 so as to sanitize the accessible surface of a luer access device (optionally a needleless medical valve), thereby reducing infection risk in the patient.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0037] FIG. 1 is a drawing of a representative needleless connector (1), a type of luer access device suited for cleansing by the devices and methods of the invention. The needleless connector shown is a valve or port that provides a flow path (6 to 5) through the valve's proximal end (2) to its distal end (4). The proximal end (2) has luer threads (3) that allow it to be connected to a complementary female luer fitting. The distal end (4) includes a female luer fitting adapted to engage the threaded male portion of another device.

[0038] FIGS. 2-10 show several drawings of different representative embodiments of sanitizing articles according to the invention and some of the components thereof.

DESCRIPTION OF REPRESENTATIVE EMBODIMENTS

[0039] FIGS. 2-10 depict several representative embodiments of sanitizing articles according to the invention. FIG. 2 shows a cross-section of a sanitizing article (10) having a sealed container 15 that forms an internal cavity (20) in which a multi-part sanitizing component (30) is disposed. Preferably, such an article is provided to end users in sterile form, although sterilization is not essential in all embodiments. The sanitizing component (30) shown has two parts, a cleansing matrix (36) and a substrate (32). The substrate (32) includes a cleaning port or recess (34), and is in a top (or bottom) view in FIG. 3. The cleansing matrix (36) includes a sanitizing reagent (shown as particles) dispersed therein. As will be appreciated, in the embodiment shown in this Figure, the sanitizing article's container does not contain an access port or a removable cover (see instead FIG. 8, described below); instead, the article (10) is designed to be opened (for example, by peeling, tearing, or otherwise opening the container (15)) and the sanitizing component (30) removed therefrom prior to use to sanitize a luer access device (not shown).

[0040] FIG. 4 has 2 panels, panel 4A and panel 4B. Each panel shows a different embodiment of representative associations between the cleansing matrix (36) and substrate (32) of two different representative sanitizing component (30) structures. These sanitizing component (30) structures can be employed in embodiments of the invention wherein they remain inside the sanitizing article (10) and are thus accessed through an access port (16) in the container (15) or after they have been removed from the container (15).

[0041] In panel 4A, the upper drawing shows a substrate (32) underneath a substantially flat cleansing matrix (36) impregnated with a sanitizing reagent. To use the sanitizing component (30) (for example, after removing it from a container), a user would push the portion of the luer access device to be sanitized into the cleansing matrix (36) so as to force the luer access device and cleansing matrix into the cleaning port (34) so as to bring the luer access device and cleansing matrix into sanitizing association, as shown in the lower drawing of panel 4A.

[0042] Similarly, in panel 4B, the upper drawing shows a substrate (32) underneath a bunched cleansing matrix (36) impregnated with a sanitizing reagent. Here, the bunched cleansing matrix (36) is larger than that shown in panel 4A so as to ensure that as the matrix is pushed into the cleaning port (34), sufficient material remains so as to prevent some or all of the cleansing matrix from being completely pushed through the cleaning port (34), which could reduce the association between the matrix and luer access device in the region being cleaned, thus possibly limiting the efficacy of the device. To use the sanitizing component (30) (for example, after removing it from a container), a user would push the portion of the luer access device to be sanitized into the cleansing matrix (36) so as to force the luer access device and cleansing matrix into the cleaning port (34) so as to bring the luer access device and cleansing matrix into sanitizing association, as shown in the lower drawing of panel 4B. During this process, a user will preferably rotate the luer access device and cleansing matrix in relation to each other while it is in sanitizing association with the cleansing matrix so as to optimize the mechanical friction between the luer access device and cleansing matrix. As will be appreciated, such pushing and rotating provides a scrubbing action to sanitize a portion of the luer access device. Again, such a sanitizing component (30) structure can be employed in embodiments of the invention wherein it remains inside a sanitizing article (10) and is thus accessed through an access port (16) in the container (15) or after it has been removed from the container (15)

[0043] FIG. 5 shows two drawings of a representative embodiment of a sanitizing component wherein the substrate includes engaging structures (40) to further facilitate sanitizing association between the substrate (32) and cleansing matrix (36). As shown in the embodiment depicted in FIG. 5, the engaging structures (40) begin in the same plane as the substrate and are defined by the perimeter of the cleaning port (34). As a luer access device is pushed into the cleansing matrix (36) and into the cleaning port (34), the engaging structures (40) are pushed downward. Here, they may be, for example, pie slice-shaped pieces of material in a region of the substrate that has been processed to produce such features, for example, by scoring the surfaces of the substrate to provide for such pieces when another item, for example, a needlefree connector and associated portion of a cleansing matrix, are pushed into the substrate with sufficient force so as to cause the engaging structures (40) to be pushed downward and apart from each other. Those in the art will also appreciate that the invention envisions the use of any suitable engaging structure, or set of structures, to provide the functionality of forming a sanitizing association between region of a luer access device and the cleansing matrix. This also includes adding another article, e.g., an engaging element insert, to the substrate in the region of the cleaning port. In many embodiments, it is desirable that the engaging elements (40) have some degree of resilience so as to facilitate formation and maintenance of a sanitizing association, including friction, between the luer access device and cleansing reagent. As is the case with other embodiments, such a sanitizing component (30) structure can be employed in embodiments of the invention wherein it remains inside a sanitizing article (10) and is thus accessed through an access port (16) in the container (15) or after it has been removed from the container (15)

[0044] FIG. 6 contains two drawings, an upper drawing and a lower drawing, each showing a cross-section of a sanitizing component (30) in which the substrate includes a recess that forms a well (33). The upper drawing shows a cross-section of a sanitizing component (30) prior to insertion of a luer access device such as a needleless connector. The lower drawing shows the same sanitizing component (30) after to insertion of a luer access device into the cleansing matrix (36) and into the well (33). Again, such a sanitizing component (30) structure can be employed in embodiments of the invention wherein it remains inside a sanitizing article (10) and is thus accessed through an access port (16) in the container (15) or after it has been removed from the container (15).

[0045] FIG. 7 also contains two drawings, an upper drawing and a lower drawing, each of which shows a cross-section of yet another sanitizing component (30) embodiment in which the substrate (32) includes a depression adapted to receive the cleansing matrix (36) that contains a sanitizing reagent. In the lower drawing, the substrate (32) further includes a cleansing recess that forms a well (33) in a portion of the substrate that contains the depression adapted to receive the cleansing matrix (36). As is the case for many embodiments, sanitizing component (30) structures such as shown in FIG. 7 can be used in embodiments wherein it remains inside a sanitizing article (10) and is thus accessed through an access port (16) in the container (15) or after it has been removed from the container (15).

[0046] FIG. 8 is an illustration showing a representative embodiment of a sanitizing article (10) wherein the sanitizing component (30) is retained in the internal cavity (20) of the container (15) and is accessed via a access port (16) or opening in the upper portion of the container (15) after removal of a removable cover (17) adhered or otherwise attached so as to seal the container until the cover (17) is removed, for example, by peeling. The cover (17) can be attached to an outer surface of the container (15) using any approach suitable for the particular materials, etc. Such attachment can be, for example, through the use of a suitable adhesive (18), by heating sealing, ultrasonic welding, or the like. The sanitizing component (30) is typically positioned in the internal cavity (20) of the container (15) such that the cleansing matrix is disposed between the substrate (32) and access port (16). When the cover (17) is removed (e.g., peeled off) from the sanitizing article (10), the access port (16) is exposed. A user wishing to sanitize a needleless connector, for example, can then insert the connector through the access port (16). This allows the valve portion (2) of the connector to contact the cleansing matrix (36) and, as the user further pushes the connector into the sanitizing article (10), the cleansing matrix (36) and valve portion (2) are inserted into the cleaning port (34) (or recess; see, e.g., FIG. 6) in sanitizing association. Rotation of the sanitizing article (10) in relation to the connector (1), by movement of one, the other, or both of them, for example, for 1-30 or more seconds, allows the connector (or other luer access device) to be sanitized. Such sanitizing is preferably performed immediately before a fluid connection is made to the luer access device. Compliance with such “scrub the hub” procedures helps to reduce the risk that a patient into whom fluid was administered via such luer access device will contract a blood stream infection due to microbial contamination. Those in the art will appreciate that other multi-part sanitizing component configurations, for example, those shown in FIGS. 4, 5, 6, 7, and 9, can alternatively be used.

[0047] FIG. 9 is an illustration of another representative embodiment of a multi-part sanitizing component (30) useful in practicing the invention. In this and related embodiments, the surface of the substrate (32) that faces the cleansing matrix (36) includes one or more retention features or elements (60) that engage one or more areas of the cleansing matrix (36) to help it. Such embodiments preferably utilize cleansing matrices (36) that include sufficient extra material to allow a portion of it to extend into and through the cleaning port when pushed into it by a luer access device.

[0048] FIG. 10 shows a representative embodiment of the invention wherein the sanitizing component lacks a substrate. Instead, the sanitizing article (11) contains a sanitizing matrix (36) housed in a container (15) that includes an access port (16) and cover (17) therefor adhered or otherwise attached to the container's (15) upper surface. In use, the lower portion of the container, beneath the sanitizing matrix (36), can be used as the substrate. For example, a user could grip the sanitizing article (11) between the fingers of one hand and remove and discard the cover (17) with her/his other hand. S/he could then grasp a luer access device, for example, a needleless connector (see, e.g., FIG. 1) with her/his free hand and insert its threaded valve portion into the article's internal cavity (20) so as to bring it into contact with the sanitizing matrix (36). The user's gripping action of the container can form a well into which the sanitizing matrix (36) and luer access device can be brought into sanitizing association such that the luer access device can then be sanitized.

[0049] Again, such a sanitizing component (30) structure can be employed in embodiments of the invention wherein it remains inside a sanitizing article (10) and is thus accessed through an access port (16) in the container (15) or after it has been removed from the container (15).

[0050] All of the compositions, articles, and methods described and claimed herein can be made and executed without undue experimentation in light of the present disclosure. While the, articles and methods of this invention have been described in terms of preferred embodiments, it will be apparent to those of skill in the art that variations may be applied to the articles, methods, and compositions without departing from the spirit and scope of the invention. All such variations and equivalents apparent to those skilled in the art, whether now existing or later developed, are deemed to be within the spirit and scope of the invention as defined by the appended claims.

[0051] All patents, patent applications, and publications mentioned in the specification are indicative of the levels of those of ordinary skill in the art to which the invention pertains. All patents, patent applications, and publications are herein incorporated by reference in their entirety for all purposes and to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference in its entirety for any and all purposes.

[0052] The invention illustratively described herein suitably may be practiced in the absence of any element(s) not specifically disclosed herein. Thus, for example, in each instance herein any of the terms “comprising”, “consisting essentially of”, and “consisting of” may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.