This relates to the field of medical devices and more particularly to devices for cleaning and decontaminating a medical device such as a luer connector.
In catheter assemblies such as are used in hemodialysis, proximal ends of the catheters are terminated in luer connectors that are disposed outside of the patient, and the luer connectors enable easy and rapid connection to respective fluid lines of the hemodialysis apparatus in a manner permitting easy and rapid disconnect. Of course, when unconnected to the fluid lines, the ends of the luer connectors are exposed to debris and contamination and require cleaning and decontamination prior to each connection. Prior art cleaner devices for medical and dental devices, generally, are set forth in U.S. Pat. Nos. 4,439,884; 5,471,706; 6,045,539; and 6,086,275; and in U.S. Patent Publication No. US 2008/0235888.
More recently, devices for cleaning luer connectors are known from U.S. Patent Publication No. 2006/0030827 and from U.S. Pat. No. 7,704,002. The luer cleaners set forth therein include a generally hollow body having an open first end, a closed second end, and a longitudinal axis extending therethrough between the first end and the second end. The first end is sized to receive therein the proximal end of the luer connector and includes a plurality of scrubbing elements extending generally toward the longitudinal axis sufficiently to engage the luer connector disposed therein. The second end comprises a compressible reservoir containing a cleaning fluid, wherein, when the second end is compressed, or the reservoir punctured as in the above-mentioned patent, the fluid is transmitted from the reservoir toward the first end and to the scrubbing elements. When the luer cleaner is inserted over the proximal end of the luer connector and preferably is rotated reciprocally several times about the luer's axis, the scrubbing elements engage and mildly scrub the outer surfaces of the luer connector's proximal end, including the male connector threads, to dislodge debris, and the cleaning fluid washes and thus cleans and decontaminates the luer connector end when the luer cleaner is removed from the luer connector.
It is desired to provide a cleaning device that is simple and economical to manufacture and effective in cleaning a medical device such as a luer connector.
It is further desired to provide an effective cleaning device needing no discrete reservoir for antimicrobial fluid.
Briefly, the present invention is a cleaner assembly having a housing defining a device-receiving cavity open at a first end and extending to a transverse bottom forming a closed second end. One or more scrubbing components are affixed within the cavity containing scrubbing portions that engage surfaces of the medical device inserted into the cavity thereby scrubbing them upon manipulation of the medical device, or manipulation of the cleaner assembly with respect to the medical device. The housing is preferably cup-shaped, and preferably, a cover is affixed across the open first end of the cup housing to seal the interior, which cover is peelable from the cup when desired to clean a medical device. Such a cover could be of a semi-permeable material permitting sterilization of the cleaner assembly upon completion of manufacturing.
In a first embodiment, a scrubber component of easily compressible material is affixed within the device-receiving cavity traversing the transverse bottom, the scrubber being imbued with antimicrobial fluid and preferably comprising an open-celled foam material. Preferably, the scrubber defines an array of compressible fingers extending toward the open first end to be engaged by the inserted end of the medical device. Upon insertion, the device engages and compresses the fingers, releasing the antimicrobial fluid, and as the device is rotated and moved reciprocally, the exterior surfaces adjacent the device end, and the end surfaces and adjacent interior surfaces are scrubbed by the fingers and are sterilized by the antimicrobial fluid.
In a second embodiment, a first scrubber component of easily compressible material is affixed within the device-receiving cavity traversing the transverse bottom, the scrubber being imbued with antimicrobial fluid and preferably comprising an open-celled foam material, similarly to the first embodiment hereinabove described. Preferably the first scrubber defines an array of compressible fingers extending toward the open first end to be engaged by adjacent surface portions of the inserted end of the medical device for scrubbing thereof. Also, upon insertion, the end portion of the device engages and compresses the fingers releasing the antimicrobial fluid, whereby the device surface portions are sterilized by the antimicrobial fluid. The assembly further includes a second scrubber component affixed within the device-receiving cavity proximally of the first scrubber component. The second scrubber component is affixed to the side walls of the cavity adjacent the open first end of the cavity and extending about halfway along the depth of the cavity. The second scrubber component defines an array of scrubber projections protruding radially inwardly from the cavity side walls to engage outer side surfaces of the end portion of the medical device inserted into the device-receiving cavity; the second scrubber may be made of an elastomeric material such as silicone rubber.
In a third embodiment, the cleaner assembly may comprise just the second scrubber component of the previously described embodiment, alone within the device-receiving cavity.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate the presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain the features of the invention. In the drawings:
In the drawings, like numerals indicate like elements throughout. Certain terminology is used herein for convenience only and is not to be taken as a limitation on the present invention. The terms “distal” and “proximal” refer, respectively, to directions closer to and away from a luer connector to be cleaned. The terminology includes the words specifically mentioned, derivatives thereof and words of similar import. The terms and expressions used herein, and the embodiments illustrated below, are not intended to be exhaustive or to limit the invention to the precise form disclosed. These terms, expressions and embodiments are chosen and described to best explain the principle of the invention and its application and practical use and to enable others skilled in the art to best utilize the invention.
One embodiment of cleaner assembly 10 is shown in
Cleaner assembly 10 is shown in cross-section in
First scrubber component 22, as seen in of the first scrubber component toward the open first end of the housing 12. Preferably, the first scrubber component is a one-piece or integral component of easily compressible material, such as open-celled foam material, capable of retaining saturated therein an antimicrobial fluid for sanitizing the medical device (not shown) inserted into the cavity upon compressing the fingers 26 during cleaning.
An exemplary foam material for scrubber component 22 is open-celled or close-celled polyurethane foam. Fingers 26 may be formed in the component by forming a gridwork of cuts 28 into a proximal end of the scrubber component extending about halfway along the length of the scrubber component, to about its medial transverse plane , thus providing separation of the resultant “fingers” 26 from each other. Such cuts may be formed by die cutting. The fingers 26 may be of equal length or, as seen in
Second scrubber component 30 is depicted in
Flexible projections 34 of second scrubber component 30 may be blunt-ended as shown in
Cup-shaped housing 12 may be formed of any suitable plastic materials such as polyethylene, polypropylene and the like; preferably, housing 12 is of PETG, or polyethylene terephthalate glycol material. Peelable lid 22 may preferably be TYVEK (trademark of E. I. DuPont de Nemours & Co.) high density polyethylene material, or similar material, adhered across the proximal end of housing 12, such as by heat sealing. Such a lid forms a semipermeable membrane permitting infusion of sterilization gas into the cleaner assembly, such as ethylene oxide, for sterilization of the assembly after completion of its manufacturing. Preferably, the second scrubber component's proximal edge is recessed slightly into the cavity so as not to interfere with sealing of the lid 40 to the housing proximal end.
In accordance with the present invention, the cleaner assembly may utilize the cup-shaped housing, with peelable lid, and only utilize a single scrubber component at least similar to second scrubber component 30 of
Cleaner assembly 110 is shown in
Scrubber component 22 defines an array of fingers 26 co-extending toward the open first end 114 to engage a medical device inserted into the cavity 118. Fingers 26 extend preferably from about the median transverse plane of the scrubber component to at least proximate the open first end of the housing 112. Preferably, the scrubber component, similarly to scrubber component 22 of
Fingers 26 may be formed in the component by forming a gridwork of cuts 28 into a proximal end of the scrubber component extending about halfway along the length of the scrubber component, to about its medial transverse plane , thus providing separation of the resultant “fingers” 26 from each other. Such cuts may be formed by die cutting. The fingers may be of equal length, as seen in
It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but it is intended to cover modifications within the spirit and scope of the present invention as defined by the appended claims.
This application claims priority from U.S. Provisional Patent Application Ser. No. 61/357,730 filed Jun. 23, 2010.
Number | Date | Country | |
---|---|---|---|
61357730 | Jun 2010 | US |