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EXPRESS MAIL LABEL NO.:ER493074446
`
`ATTORNEY DOCKET NO.:
`
`TITLE OF THE INVENTION
`
`Luer Cleaner
`
`CROSS-REFERENCE TO RELATED APPLICATION
`
`[0001] This relates to and claims priority from Provisional U.S. Patent Application
`
`Serial No. 60/587,790 filed July 14, 2004.
`
`FIELD OF THE INVENTION
`
`[0002] The present invention relates to medical device, and more particularly to an
`
`The present invention relates to an apparatus for cleaning male threads on a luer connector that is
`attached to a catheter assembly implanted on a patient.
`
`BACKGROUND OF THE INVENTION
`
`(0003] In catheter assemblies such as are used in hemodialysis, proximal ends of the catheters
`
`are tenninated 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 permit-
`
`ting 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.
`
`SUMMARY OF THE INVENTION
`
`[0004] The present invention is a luer cleaner 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
`
`1
`
`BAXTER EXHIBIT 1018
`Page 1 of 17
`
`

`

`EXPRESS MAIL LABEL NO.: EQ007133298US
`
`ATTORNEY DOCKET NO.: MED-0080
`
`connector and includes a plurality of bristles extending generally toward the longitudinal axis
`
`sufficiently 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 bristles engage and mildly scrub the outer surfaces of the luer connector'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. The method of the present invention includes: inserting a luer connector proximal end
`
`into a luer cleaner open end so that bristles within the luer cleaner engage the luer proximal end
`
`outer surfaces to scrub them; compressing the luer cleaner closed second end to force fluid toward
`
`the open first end through passageways to wash the luer connector end; and rotating the luer cleaner
`
`about the luer connector to scrub and clean it.
`
`[0005] 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.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0006] 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:
`
`2
`
`BAXTER EXHIBIT 1018
`Page 2 of 17
`
`

`

`EXPRESS MAIL LABEL NO.: EQ007133298US
`
`ATTORNEY DOCKET NO.: MED-0080
`
`[0007] Fig. 1 is a perspective view of a luer cleaner according to a first preferred
`
`embodiment of the present invention, with a luer being inserted into the luer cleaner.;
`
`[0008] Fig. 2 is an exploded view of the luer cleaner shown in Fig. 1.;
`
`[0009] Fig. 3 is a sectional view of the luer cleaner shown in Fig. 1.;
`
`[0010] Fig. 4 is an enlarged front view of a scrubber disc shown inside the luer cleaner.;
`
`[0011] Fig. 5 is a sectional view of the scrubber disc of Fig. 4, taken along line 5--5 of Fig.
`
`4.;and
`
`Fig[0012] Figs. 6 is aand 7 are sectional view of a luer scrubberviews ofluer cleaners
`
`according to a second preferred embodimentand third embodiments of the present invention.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0013] 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.
`
`3
`
`BAXTER EXHIBIT 1018
`Page 3 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`The tenninologyterminology 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.
`
`[0014] Referring now to Fig. 1, a luer cleaner 100 according to a first embodiment of the
`
`present invention is shown. The luer cleaner 100 is insertedinsertable over the proximal end of a
`
`luer connector 190 and rotatedrotatable axially about the luer 190. The luer 190 includes male
`
`threads 192 that are used to secure the luer 190 to another connection. The luer. Luer connector,
`
`or luer, 190 is preferably connected to a medical device, such as a hemodialysis catheter 194, or
`
`other . The proximal end ofluer 190 includes male threads 192 that are used to secure luer 190 to
`
`a second medical device (e.g., a hemodialysis apparatus) having fluid lines each terminating in a
`
`corresponding luer connector that
`
`2
`
`BAXTER EXHIBIT 1018
`Page 4 of 17
`
`

`

`incorporates a luer connection with internal, female threads. Prior to connection of the luer 190
`
`with the othersecond medical device, the luerproximal end ofluer 190 is inserted into an open end
`
`of the luer cleaner 100. As the luer cleaner 100 is rotated about the luer 190, antiseptic fluid
`
`contained in the luer cleaner 100 is forced from a reservoir in the luer cleaner 100 such as by
`
`manually applied pressure, over the luer 190, to clean debris and other contaminants that may be
`
`present on or around the luer threads 192. Also shown, along with Figs. 2 and 3, is a body 160
`
`defining a reservoir 166 for a fluid 168.
`
`[0015] Referring now to Figs. 2 and 3, the luer cleaner 100i'00 includes an open end 104, a
`
`closed end 106, and a longitudinal axis 107 extending therethrough between the open end 104 and
`
`the closed end 106. The open end 104 includes a generally tubular body 108 having a longitudinal
`
`passage 110 that extends toward the closed end 106. Preferably, the body 108 is constructed from
`
`polyvinyl chloride or some other suitable biocompatible material. The body 108 includes an
`
`exterior portion 112 that may optionally include a plurality of gripping ribs 114 extending
`
`therefrom, away from the longitudinal axis 107. The gripping ribs 114 allow a user to grip the
`
`body 108 during use of the cleaner 100. The interior of the body 108 includes at least one, and
`
`preferably two, diametrically
`
`BAXTER EXHIBIT 1018
`Page 5 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`opposed alignment notches 116 that extend from the longitudinal passage 110 away from
`
`the longitudinal axis 107.
`
`[0016] 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 the reservoir that has
`
`been forced into the longitudinal passage 110 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-sectioncross- section view of Fig. 3.
`
`4
`
`BAXTER EXHIBIT 1018
`Page 6 of 17
`
`

`

`[0017) 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 Fig. 3). The passages 119 are preferably parallel to the longitudinal axis
`
`107 and each passage 119 is disposed ninety degrees apart from each adjacent passage 119.
`
`[0018) The body 108 also includes an annular ribflange 120 that extends from the body 108,
`
`away from the open end 104 of the luer cleaner 100. The ribflange 120 extends outwardly of the
`
`passages 119, with a lip 122 being formed between the ribflange 120 and the exterior portion 112 of
`
`the body 108.
`
`[0019) A tubular connectorcollar 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
`
`connectorcollar 123 includes a ribcorresponding lip 124 that extends circumferentially around the
`
`connector 123,therearound and that is sized to surround and engage the connector 123 with the
`
`ribflange 120 of the body 108, as is seen in Fig. 3. The connection between the connectorcollar
`
`123 and the body 108 may bemaybe an interference fit, a threaded connection, an adhesive-based
`
`connection, or some other suitable connection known to those skilled in the art.
`
`BAXTER EXHIBIT 1018
`Page 7 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`[0020) The connectorcollar 123 also includes a connectorconnecting passage 125 that extends
`through the connector
`
`collar 123, generally along the longitudinal axis 107. When the connectorcollar 123 and the body
`
`108 are engaged with each other, a generally circular throughway 126 is formed between the body
`
`108 and the connectorcollar 123 that provides fluid communication between the
`
`connectorconnecting passage 125 and the passages 119 in the body 108.
`
`[0021] A scrubber 130 is disposed within the longitudinal passage 110. The scrubber 130
`
`and is preferably constructed from at least one, and preferably a plurality, of scrubber discs 131.
`
`Details of thea scrubber disc 131 are shown in Figs. 4 and 5. Each; each scrubber disc 131 includes
`
`an annular ring 132, with each ring 132 having a plurality of scrubber bristles 134 extending
`
`therefrom toward the
`
`6
`
`BAXTER EXHIBIT 1018
`Page 8 of 17
`
`

`

`longitudinal axis 107. Preferably, the rings 132 and scrubber bristles 134 are constructed from
`
`polypropylene or some other suitable biocompatible material. The bristles 134 extend
`
`sufficiently far toward the center of each ring 132 so as to engage the luer threads 192 of the luer
`
`190 when the luer 190 is inserted into the luer cleaner 100.
`
`[0022) 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 thea
`
`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 into the longitudinal passage 110thereinto.
`
`[0023) Each ring 132 also includes at least one, and preferably, a plurality, of through-
`
`passagesthrough- passages 140 that allow fluid to pass from one side of each ring 132 to an
`
`opposing side of each ring 132. As seen in Fig. 4 fourFour through-passages 140 are preferred, as
`
`shown in Fig. 4, with each through-passage 140 being disposed at ninety degreeninety-degree
`
`spacings from each adjacent through-passage 140, although those skilled
`
`BAXTER EXHIBIT 1018
`Page 9 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`in the art will recognize that more or less than four through-passages 140 may be used.
`
`However, it is preferred that each through passagethrough-passage 140 fluidly communicates with
`
`a passage 119 in the body 108, so that fluid communication exists between all of the passages 140
`
`and the connectorconnecting passage 125.
`
`[0024) Further, a plurality of radiallyofradially extending channels 142 extends along an
`exterior 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
`
`Figs. 4 and 5, four channels 142 are disposed at ninety degreeninety-degree spacings apart from
`
`each adjacent channel 142, with channels 142 disposed on either side of each ring 132, although
`
`those skilled in
`
`7
`
`BAXTER EXHIBIT 1018
`Page 10 of 17
`
`

`

`the art will recognize that, for each through-passage 140, a channel 142 is preferably disposed on
`
`either face of the ring 132.
`
`[0025] With a plurality of rings 132 disposed adjacent one another, as shown in Fig. 23,
`
`the radially extending channels 142 in adjacent rings 132 form radial passages 146 that provide
`
`fluid communication between each through-passage 140 and the longitudinal passage 110 to allow
`
`fluid to be transmitted through the radial passages 146 to the longitudinal passage 110. Fluid
`
`communication is now present between the longitudinal passage 110 and the connector passage
`
`125.
`
`A[0026] Again referring to Fig. 3, sealing ring 150 is disposed between the array of rings
`132
`
`and the open end 104 of the luer cleaner 100. The sealing ring 150 preferably has an internal
`
`diameter that is approximately the same as the external diameter of the luer 190 (see Fig. 1) to
`
`prevent fluid forced manually from the reservoir 168 within bulbous body 160 and into the
`
`longitudinal passage 110, from flowing out of the luer cleaner 100 between the luer 190 and the.
`
`body 108 of the cleaner 100. The sealing ring 150 is preferably constructed from
`
`KratonKRATON™ or other suitable, flexible material, so that the sealing ring 150 generally
`
`provides a seal around the luer 190 when the luer 190 is inserted into the luer cleaner 100.
`
`BAXTER EXHIBIT 1018
`Page 11 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCK.ET NO.:
`MED-0080
`[0027] 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 190 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.
`
`6
`
`BAXTER EXHIBIT 1018
`Page 12 of 17
`
`

`

`[0028] The closed end 106 of the luer cleaner 100 includes a generally bulbous body 160
`
`constructed from KratonKRATON™, 1064 PVC, or some other suitable, compressible material.
`
`The body
`
` 160 includes an open end 162 that is fixedly and sealingly connected to the
`
`connectorcollar 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 connectorconnecting passage 125, the circular
`
`throughway 126, the passages 119, the through-passages 140, and the radial passages 146.
`
`[0029) 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. 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, betadinepovodine iodine or hydrogen peroxide, or any combination
`
`thereof, may be used instead.
`
`[0030) In use, as shown in Figand referring to Figs. 1 and 3, the luer 190, such as on a
`
`proximal end of a catheter 194, is inserted into the open end 104 of the luer cleaner 100. The
`
`sealing ring 150 engages the external
`
`BAXTER EXHIBIT 1018
`Page 13 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`portion of the luer 190, restricting fluid 156166 from being forced out of the open end 104
`
`of the luer cleaner 100.
`
`[0031) 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 out offrom the
`
`reservoir 166, through and eventually into the longitudinal passage 110 of the generally tubular
`
`body 108 by way of being forced through the connectorconnecting 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
`
`8
`
`BAXTER EXHIBIT 1018
`Page 14 of 17
`
`

`

`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 190, the luer 190 is
`
`removed from the luer cleaner 100, and the luer cleaner 100 may be discarded. The luerLuer 190
`
`is now disinfected and may be connected to an external medical device.
`
`[0032] In an alternate embodiment of a luer cleaner 200, shown in Fig. 6, a fluid 268 may be
`
`be retained in a frangible container 270 disposed within the reservoir 166. The fluid 268 may be
`
`significantly less viscous than the fluid 168 described above with respect to the luer cleaner 100
`
`(Fig. 1). The frangible container 270 prevents the fluid 268 from flowing out of the reservoir 166
`
`prior to use.
`
`[0033] To use the luer cleaner 200, the luer 190 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.
`
`BAXTER EXHIBIT 1018
`Page 15 of 17
`
`

`

`EXPRESS MAIL LABEL NO.:ER493074446US
`
`ATTORNEY DOCKET NO.:
`MED-0080
`[0034] 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.
`
`[0035] In Fig. 7, a third embodiment of luer cleaner 300 is shown. A pair of frangible
`
`containers 370 are secured to opposite sides of a tab 372, each containing quantities of fluid 368
`
`that will be expressed into and forwardly through channel 376 of tab 372 when the closed end 360
`
`10
`
`BAXTER EXHIBIT 1018
`Page 16 of 17
`
`

`

`ones of frangible containers 370, to enable the user to compress those indicated surfaces to crush
`
`and open the frangible containers, which are pressed against tab 372.
`
`[0036] 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.
`
`BAXTER EXHIBIT 1018
`Page 17 of 17
`
`

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