1111111111111111 IIIIII IIIII 11111 1111111111 11111 1111111111 1111111111 111111111111111 11111111
`US 20060030827 Al
`
`(19) United States
`(12) Patent Application Publication
`Raulerson et al.
`
`(10) Pub. No.: US 2006/0030827 Al
`Feb. 9, 2006
`(43) Pub. Date:
`
`(54) LUER CLEANER
`
`Publication Classification
`
`(75)
`
`Inventors: J. Daniel Raulerson, Brewton, AL
`(US); Timothy Schweikert, Levittown,
`PA (US); William Shaun Wall, North
`Wales, PA (US); Mark S. Fisher,
`Sellersville, PA (US)
`
`Correspondence Address:
`MONTE & MCGRAW, PC
`4092 SKIPPACK PIKE
`P.O. BOX 650
`SKIPPACK, PA 19474 (US)
`
`(73)
`
`Assignee: Medical Components,
`leysville, PA
`
`Inc., Har(cid:173)
`
`(21)
`
`Appl. No.:
`
`11/180,142
`
`(22)
`
`Filed:
`
`Jul. 13, 2005
`
`Related U.S. Application Data
`
`(60)
`
`Provisional application No. 60/587,790, filed on Jul.
`14, 2004.
`
`(51)
`
`Int. Cl.
`A61M 25/00
`(2006.01)
`(52) U.S. Cl. .............................................................. 604/267
`
`(57)
`
`ABSTRACT
`
`A luer cleaner (100) including a generally hollow body (112)
`having an open first end (104), a closed second end (106),
`and a longitudinal axis extending therethrough between the
`first end and the second end. The first end (104) is sized to
`receive therein a luer connector (190) proximal end and
`includes a plurality of bristles (134) extending generally
`toward the longitudinal axis sufficiently to engage the outer
`surfaces of the luer proximal end disposed therein. The
`second end comprises a compressible reservoir (166) con(cid:173)
`taining a fluid (168), wherein, when the second end is
`compressed, the fluid is transmitted from the reservoir
`toward the first end through passageways to wet the luer
`proximal end. A method for cleaning luer connectors is also
`disclosed.
`
`100
`
`164
`/
`
`106
`
`BAXTER EXHIBIT 1011
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`Patent Application Publication Feb. 9, 2006 Sheet 1 of 6
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`BAXTER EXHIBIT 1011
`Page 2 of 11
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`

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`Patent Application Publication Feb. 9, 2006 Sheet 2 of 6
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`US 2006/0030827 Al
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`
`BAXTER EXHIBIT 1011
`Page 3 of 11
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`

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`Patent Application Publication Feb. 9, 2006 Sheet 4 of 6
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`BAXTER EXHIBIT 1011
`Page 5 of 11
`
`

`

`Patent Application Publication Feb. 9, 2006 Sheet 5 of 6
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`BAXTER EXHIBIT 1011
`Page 6 of 11
`
`

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`Patent Application Publication Feb. 9, 2006 Sheet 6 of 6
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`BAXTER EXHIBIT 1011
`Page 7 of 11
`
`

`

`US 2006/0030827 Al
`
`Feb.9,2006
`
`1
`
`LUER CLEANER
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`[0001] This relates to and claims priority from Provisional
`U.S. Patent Application Ser. No. 60/587,790 filed Jul. 14,
`2004.
`
`FIELD OF THE INVENTION
`[0002] 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.
`
`BACKGROUND OF THE INVENTION
`
`[0003]
`In catheter assemblies such as are used in hemo(cid:173)
`dialysis, 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 respec(cid:173)
`tive 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 connec(cid:173)
`tors are exposed to debris and contamination and they
`require cleaning and decontamination prior to each connec(cid:173)
`tion.
`
`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 con(cid:173)
`nector and includes a plurality of bristles extending gener(cid:173)
`ally 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 con(cid:173)
`nector 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 con(cid:173)
`nector 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 incorpo(cid:173)
`rated herein and constitute part of this specification, illus-
`
`trate 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:
`[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
`[0012] FIGS. 6 and 7 are sectional views of luer cleaners
`according to second and third embodiments of the present
`invention.
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`
`[0013]
`In the drawings, like numerals indicate like ele(cid:173)
`ments throughout. Certain terminology is used herein for
`convenience only and is not to be taken as a limitation on the
`present invention. The terminology includes words specifi(cid:173)
`cally 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 accord(cid:173)
`ing to a first embodiment of the present invention is shown.
`The luer cleaner 100 is insertable over the proximal end of
`a luer connector 190 and rotatable axially about the luer.
`Luer connector, or luer, 190 is preferably connected to a
`medical device, such as a hemodialysis catheter 194. The
`proximal end of luer 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 incorporates internal
`female threads. Prior to connection of the luer 190 with the
`second medical device, the proximal end of luer 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
`100 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. Pref(cid:173)
`erably, 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
`
`BAXTER EXHIBIT 1011
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`

`

`US 2006/0030827 Al
`
`Feb.9,2006
`
`2
`
`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 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 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 FIG. 3.
`
`[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 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.
`[0019] 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 FIG. 3. The connection between the collar 123 and the
`body 108 may be an interference fit, a threaded connection,
`an adhesive-based connection, or some other suitable con(cid:173)
`nection known to those skilled in the art.
`
`[0020] The collar 123 also includes a connecting passage
`125 that extends through the collar 123, generally along the
`longitudinal axis 107. When the collar 123 and the body 108
`are engaged with each other, a generally circular through(cid:173)
`way 126 is formed between the body 108 and the collar 123
`that provides fluid communication between the connecting
`passage 125 and the passages 119 in the body 108.
`
`[0021] 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 FIGS. 4 and 5; each
`scrubber disc 131 includes an annular ring 132, with each
`ring 132 having a plurality of scrubber bristles 134 extend(cid:173)
`ing therefrom toward the longitudinal axis 107. Preferably,
`the rings 132 and scrubber bristles 134 are constructed from
`polypropylene or some other suitable biocompatible mate(cid:173)
`rial. The bristles 134 extend sufficiently far toward the center
`of each ring 132 so as to engage the luer threads of the luer
`when the luer 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 a respective
`alignment notch 116 cut into the body 108. Each post 136
`engages the alignment notch 116 in a generally tight, fric(cid:173)
`tional fit so that each ring 132 remains within the longitu(cid:173)
`dinal passage 110 after insertion thereinto.
`[0023] 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 pre(cid:173)
`ferred, as shown in FIG. 4, with each through-passage 140
`being disposed at ninety-degree spacings from each adjacent
`through-passage 140, although those skilled in the art will
`recognize that more or less than four through-passages 140
`may be used. However, it is preferred that each through(cid:173)
`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 connecting passage 125.
`[0024] Further, a plurality of radially 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-degree
`spacings apart from each adjacent channel 142, with chan(cid:173)
`nels 142 disposed on either side of each ring 132, although
`those skilled in the art will recognize that, for each through(cid:173)
`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. 3, the radially extending channels
`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.
`[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 and the
`body 108 of the cleaner 100. The sealing ring 150 is
`preferably constructed from KRATON™ or other suitable,
`flexible material, so that the sealing ring 150 generally
`provides a seal around the luer when the luer is inserted into
`the luer cleaner 100.
`[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 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.
`[0028] The closed end 106 of the luer cleaner 100 includes
`a generally bulbous body 160 constructed from KRA-
`
`BAXTER EXHIBIT 1011
`Page 9 of 11
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`

`

`US 2006/0030827 Al
`
`Feb.9,2006
`
`3
`
`TON™, 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.
`
`[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, povodine iodine or hydrogen
`peroxide, or any combination thereof, may be used instead.
`
`In use, and referring to FIGS. 1 and 3, the luer 190,
`[0030]
`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 portion of the luer 190, restricting
`fluid 166 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 from
`the reservoir 166 and eventually into the longitudinal pas(cid:173)
`sage 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,
`[0032]
`shown in FIG. 6, a fluid 268 may 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 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.
`
`[0034] The frangible container 270 may be constructed
`from a material that is easily broken open under compres-
`
`sion. 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 suspen(cid:173)
`s10n.
`In FIG. 7, a third embodiment of luer cleaner 300
`[0035]
`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 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.
`
`What is claimed is:
`1. A luer cleaner comprising:
`
`a generally hollow body having:
`
`an open first end, a closed second end, and a longitu(cid:173)
`dinal axis extending therethrough between the first
`end and the second end,
`
`wherein the first end is sized to receive therein a luer
`and wherein the first end includes a plurality of
`bristles extending generally toward the longitudinal
`axis sufficiently to engage the luer disposed therein;
`and
`
`wherein the second end comprises a compressible
`reservoir containing a fluid, wherein, when the sec(cid:173)
`ond end is compressed, the fluid is transmitted from
`the reservoir toward the first end.
`2. The luer cleaner according to claim 1, wherein the fluid
`is an antiseptic fluid.
`3. The luer cleaner according to claim 1, wherein the
`plurality of bristles comprises at least one ring disposed in
`the open end, and wherein the plurality of bristles extend
`from the at least one ring toward the longitudinal axis.
`4. The luer cleaner according to claim 3, wherein the at
`least one ring comprises a plurality of rings.
`5. The luer cleaner according to claim 1, wherein the
`reservoir is defined within an initially separate compressible
`body joined to the hollow cleaner body remote from the
`open first end.
`6. The luer cleaner according to claim 5, wherein the
`separate compressible body further comprises a collar dis(cid:173)
`posed thereon forwardly of the reservoir, for being joined
`sealingly with the hollow cleaner body.
`7. The luer cleaner according to claim 1, wherein the body
`further comprises an exterior portion, wherein the exterior
`portion comprises a plurality of ribs extending therefrom,
`away from the longitudinal axis.
`8. The luer cleaner according to claim 1, further compris(cid:173)
`ing a centering post disposed along the longitudinal axis and
`within the open first end, complementary to the open proxi(cid:173)
`mal end of a luer connector that closes the open proximal
`end upon full insertion of the luer connector proximal end
`into the open first end of the luer cleaner body.
`
`BAXTER EXHIBIT 1011
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`

`US 2006/0030827 Al
`
`Feb.9,2006
`
`4
`
`9. The luer cleaner according to claim 1, wherein the fluid
`is retained in a frangible capsule within the compressible
`reservmr.
`10. The luer cleaner according to claim 1, wherein the
`fluid is retained in two frangible capsules within the com(cid:173)
`pressible reservoir, separated from each other by a tab
`having a channel extending forwardly toward the luer
`cleaner first end.
`11. The luer cleaner according to claim 1, wherein, in the
`absence of compression of the reservoir, the fluid is suffi(cid:173)
`ciently viscous to remain within the reservoir.
`12. The luer cleaner according to claim 1, comprising at
`least one passageway for communicating the fluid from the
`reservoir to the first end.
`13. A method of cleaning a luer comprising the steps of:
`
`(a) providing a luer cleaner comprising:
`
`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,
`
`wherein the first end is sized to receive therein a luer
`and wherein the first end includes a plurality of
`bristles extending generally toward the longitudinal
`axis sufficiently to engage the luer disposed therein;
`and
`
`wherein the second end comprises a compressible
`reservoir adapted to receive and retain a fluid,
`
`wherein, when the second end is compressed, the
`fluid is transmitted toward the first end;
`
`(b) inserting a luer into the open end, wherein the
`plurality of bristles engage an exterior of the luer;
`and
`
`(c) compressing the second end and transmitting the
`fluid to the luer and to the plurality of bristles.
`14. The method according to claim 13, further comprising
`rotating the luer about the longitudinal axis.
`15. The method according to claim 14, wherein rotating
`the luer about the longitudinal axis further comprises recip(cid:173)
`rocally rotating the luer in each of two directions.
`16. A luer cleaner comprising:
`
`a generally hollow body having:
`
`an open first end, a closed second end, and a longitu(cid:173)
`dinal axis extending therethrough between the first
`end and the second end,
`
`means for scrubbing a luer disposed at the first end; and
`
`a reservoir for retaining a fluid at the second end and for
`transmitting the fluid from the second end toward the
`first end.
`
`* * * * *
`
`BAXTER EXHIBIT 1011
`Page 11 of 11
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