The present invention relates to medical device, and more particularly to an apparatus for cleaning a luer connector that is attached to a catheter assembly implanted on a patient.
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 they require cleaning and decontamination prior to each connection.
The present invention is a cleaner for a medical device such as a luer connector, or luer, that includes 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 scrubber to engage the luer connector disposed therein. The second end comprises a compressible reservoir containing a fluid, wherein, when the second end is compressed, the fluid is transmitted from the reservoir toward the first end. 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 scrubber engages and mildly scrubs the outer surfaces of the luer's proximal end, including the male connector threads, to dislodge debris, and the fluid washes and thus cleans and decontaminates the luer connector end when the luer cleaner is removed from the luer connector. Preferably, the scrubber includes a plurality of generally pointed flexible projections or bristles, extending generally radially inwardly toward the longitudinal axis sufficiently to engage the luer. The scrubber may comprise at least one disc, or preferably a plurality of discs, each having a plurality of flexible projections or bristles on a ring thereof.
The present invention further includes a scrubber having a peripheral body and a plurality of flexible generally pointed projections extending radially inwardly therefrom, to engage outer surfaces of a medical device inserted therethrough. Even further, the present invention includes a cleaner for a medical device including a hollow body containing one or more scrubbers each having flexible projections extending radially inwardly to engage and scrub outer surfaces of a medical device inserted into the hollow body.
The method of the present invention includes: inserting a luer proximal end into a luer cleaner open end so that a scrubber within the luer cleaner engages the luer proximal end outer surfaces to scrub them; compressing the luer cleaner's closed second end to force fluid toward the open first end through passageways to wash the luer's proximal end. The method preferably includes the step of rotating or reciprocally rotating the luer cleaner about the thus-inserted luer to scrub and clean it.
Other embodiments of the luer cleaner provide a frangible capsule within the reservoir at the second luer cleaner end that contains the fluid and that expresses the fluid when crushed; and provide a pair of frangible capsules within the reservoir, that contain the fluid and together express the fluid.
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 words “proximal” and “distal” refer to directions away from and closer to, respectively, the inserted portion of the catheter assembly within the patient's vasculature. The terminology includes words specifically mentioned, derivatives thereof, and words of similar import. The following describes preferred embodiments of the invention. However, it should be understood based on this disclosure that the invention is not limited by the preferred embodiments described herein.
Referring now to
Referring now to
The body 108 further includes a guide member 117 that extends partially into the longitudinal passage 110 along the longitudinal axis 107 toward the open end 104. The guide member 117 preferably includes a male luer taper 118 to engage a female luer connection on the luer 190. The guide member 117 prevents fluid from entering the catheter 194 through the interior of the luer 190 after the fluid has been forced into the longitudinal passage 110 from the reservoir. The guide member 117 is preferably integrally molded with the body 108, as seen in the cross-section view of
At least one and preferably four passages 119 are disposed within the body 108 between the exterior portion 112 of the body 108 and the guide member 117 (although only two passages 119 are shown in
The body 108 also includes an annular flange 120 that extends from the body 108, away from the open end 104 of the luer cleaner 100. The flange 120 extends outwardly of the passages 119, with a lip 122 being formed between the flange 120 and the exterior portion 112 of the body 108.
A tubular collar 123, having an approximately “T-shaped” cross section, is fixedly connected to the body 108, distal from the open end 104 of the luer connector 100. The collar 123 includes a corresponding lip 124 that extends circumferentially therearound and that is sized to surround and engage with the flange 120 of the body 108, as is seen in
The collar 123 also includes a connecting passage 125 that extends through the collar 123, generally along the longitudinal axis 107, with the connecting passage having a small diameter, as seen in
A scrubber 130 is disposed within the longitudinal passage 110 and is preferably constructed from at least one, and preferably a plurality, of scrubber discs 131. Details of a scrubber disc 131 are shown in
Preferably, the ring 132 for each scrubber disc 131 includes at least one, and preferably two diametrically opposed, alignment posts 136 that extend from the outer perimeter of the ring 132 away from the center of the ring 132. Each post 136 is sized and shaped to fit into a respective alignment notch 116 cut into the body 108. Each post 136 engages the alignment notch 116 in a generally tight, frictional fit so that each ring 132 remains within the longitudinal passage 110 after insertion thereinto.
Each ring 132 also includes at least one, and preferably, a plurality of through-passages 140 that allow fluid to pass from one side of each ring 132 to an opposing side of each ring 132. Four through-passages 140 are preferred, as shown in
Further, a plurality of radially extending channels 142 extends along transverse surfaces of each ring 132 from the outer perimeter of the ring 132 to the inner diameter of the ring 132, with each channel 142 fluidly communicating with a through-passage 140. As can be discerned from
With a plurality of rings 132 disposed adjacent one another, as shown in
Again referring to
A cap 152 is disposed on the open end 104 of the luer cleaner 100 to retain the sealing ring 150 and the array of scrubber rings 132 within the luer cleaner 100. The cap 152 is preferably annular, with a generally circular central opening 154 that is sized to allow the luer to be inserted therethrough. The cap 152 is preferably fixedly connected to the body 108, such as with an adhesive, although those skilled in the art will recognize that the cap 152 may be retained by other methods, such as by interference fit, or a threaded connection.
The closed end 106 of the luer cleaner 100 includes a generally bulbous body 160 constructed from KRATON™, 1064 PVC, or some other suitable, compressible material. The body 160 includes an open end 162 that is fixedly and sealingly connected to the collar 123 and a closed end 164 disposed away from the open end 162. The interior of the bulbous body 160 defines a compressible reservoir 166. A fluid 168 is disposed within the reservoir 166 such that the reservoir 166 fluidly communicates with the longitudinal passage 110 of the generally tubular body 108 through the connecting passage 125, the circular throughway 126, the passages 119, the through-passages 140, and the radial passages 146.
Preferably, the fluid 168 is a fluid having antiseptic properties, such as alcohol. More preferably, the fluid 168 is sufficiently viscous to remain in the reservoir 166 in the absence of a compressive force on the body 160 of the reservoir 166, considering the small diameter of connecting passage 125. Such a preferred fluid 168 is isopropyl alcohol in a polymer suspension, such as polyvinyl alcohol, sold commercially by GOJO Industries as PURELL®, although those skilled in the art will recognize that other fluids, including, but not limited to, povodine iodine or hydrogen peroxide, or any combination thereof, may be used instead.
In use, and referring to
After the luer 190 is fully inserted into the open end 104 of the luer cleaner 100, the bulbous body 160 is then compressed, forcing the fluid 168 in the reservoir 166 from the reservoir 166 and eventually into the longitudinal passage 110 of the generally tubular body 108 by way of being forced through the connecting passage 125, the circular throughway 126, the passages 119, the through-passages 140, and the radial passages 146, to the longitudinal passage 110 and thus to the exterior of the luer 190. The luer 190 is rotated about the longitudinal axis 107 of the luer cleaner 100, in a preferably back-and-forth motion, so that the bristles 134 on the scrubber discs 131, in conjunction with the fluid 168, clean contaminants from the exterior of the luer 190, including the luer threads 192. After several seconds of scrubbing, the luer is removed from the luer cleaner 100, and the luer cleaner 100 may be discarded. Luer 190 is now disinfected and may be connected to an external medical device.
In an alternate embodiment of a luer cleaner 200, shown in
To use the luer cleaner 200, the luer is inserted into the open end 104 as described above with respect to the luer cleaner 100. The user compresses the reservoir 166 toward the longitudinal axis 107, breaking the frangible container 270, and allowing the fluid 268 to flow from the reservoir 166 and to the longitudinal passage 110 as described above with respect to the luer cleaner 100.
The frangible container 270 may be constructed from a material that is easily broken open under compression. The fluid 268 may be the same as the fluid 168 described above, or the fluid 268 may be a less viscous fluid, such as, for example, isopropyl alcohol without any suspension.
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 relates to and claims priority from Provisional U.S. Patent Application Ser. No. 60/587,790 filed Jul. 14, 2004.
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