(19) United States
`(12) Patent Application Publication (lO) Pub. No.: US 2009/0205151 A1
`Fisher et al. (43) Pub. Date: Aug. 20, 2009
`
`US 20090205151A1
`
`(54)
`
`LUER CLEANER WITH SELF-PUNCTURING
`RESERVOIR
`
`(75)
`
`Inventors:
`
`Mark S. Fisher, Sellersville, PA
`(US); W. Shaun Wall, North Wales,
`PA (US); Kevin Sanford, Chalfont,
`PA (US)
`
`Correspondence Address:
`Fox Rothschild LLP
`Blue Bell
`2000 Market Street, Tenth Floor
`Philadelphia, PA 19103 (US)
`
`(73)
`
`Assignee:
`
`Medical Components, Inc,
`Harleysville, PA (US)
`
`(21)
`
`Appl. No.:
`
`12/372,057
`
`(22)
`
`Filed:
`
`Feb. 17, 2009
`
`Related U.S. Application Data
`
`(60)
`
`Provisional application No. 61/066,262, filed on Feb.
`19, 2008.
`
`Publication Classification
`
`(51)
`
`Int. Cl.
`BO8B 1/00
`
`(2006.01)
`
`(52) U.S. Cl ...................................................... 15/104.04
`
`(57)
`
`ABSTRACT
`
`A luer cleaner assembly (100) for cleaning luer fittings (190)
`secured to proximal ends of medical tubing. The luer cleaner
`(100) includes a luer-receiving cavity (124) within which are
`contained scrubbers (110) that scrub exposed outer surfaces
`ofa luer fitting inserted thereinto through an open distal end
`(106) of the luer cleaner housing (102). The luer cleaner
`includes at a proximal end a fluid reservoir (160) containing a
`cleaning fluid (162) such as isopropyl alcohol. The assembly
`further includes a reservoir-penetrating array of sharp pointed
`projections (132), such that during luer cleaning the reservoir
`(160) is pressed distally toward the luer fitting inthe cavity for
`the array of projections to penetrate a distal cover (166) of the
`reservoir to access the cleaning fluid (162) which then flows
`distally through passageways (134,126) into the luer-receiv-
`ing cavity and onto the scrubbers (110) and the outer surfaces
`of the luer fitting (190).
`
`166
`1 16
`
`132
`
`130
`124
`
`110
`
`198
`
`190
`
`11
`
`CCI 2003
`
`1
`
`

`

`116
`
`j 160
`~/./
`j 104
`~ 102
`
`100
`
`Fig. 1
`
`106
`
`28 ZJOIwas6002‘0z'3HVuozmuqndHoneouddvmmm
`
`
`
`
`
`
`
`16
`
`114
`
`66
`
`16
`
`Fig. 2
`
`32
`
`3O
`
`110
`
`190
`
`Fig. 5
`
`IVISISOZ0/600ZSfl
`
`2
`
`

`

`Patent Application Publication Aug. 20, 2009 Sheet 2 of 2 US 2009/0205151 A1
`
`60
`
`!~16
`
`/106.
`
`.~102
`
`t4
`
`10.4
`
`1 O0/
`
`1 O0~
`
`Fig. 3
`
`3
`
`

`

`US 2009/0205151 A1
`
`Aug. 20, 2009
`
`LUER CLEANER WITH SELF-PUNCTURING
`RESERVOIR
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`[0001] This application claims priority from U.S. Provi-
`sional Patent Application Ser. No. 61/066,262, filed Feb. 19,
`2008.
`
`FIELD OF THE INVENTION
`
`[0002] This relates to the field of medical devices, andmore
`particularly to devices for cleaning luer connectors on medi-
`cal tubing.
`
`BACKGROUND OF THE INVENTION
`
`[0003] In catheter assemblies such as are used in hemodi-
`alysis, 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-
`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 connectors
`are exposed to debris and contamination and they require
`cleaning and decontamination prior to each connection.
`[0004] A device for cleaning luer connectors is known from
`U.S. Patent Publication No. 2006/0030827. The luer cleaner
`set forth therein 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 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 contain-
`ing a cleaning fluid, wherein, when the second end is com-
`pressed, 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 recipro-
`cally several times about the luer’s axis, the scrubbing ele-
`ments 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.
`[0005] It is desired to provide a mechanism for controlla-
`bly, assuredly and easily accessing the fluid-containing res-
`ervoir.
`
`BRIEF SUMMARY OF THE INVENTION
`
`[0006] Briefly, the present invention is a luer cleaner assem-
`bly having an actuation section within the housing that, when
`activated, accesses the fluid reservoir from within the luer
`cleaner assembly, permitting the cleaning fluid in the reser-
`voir to enter the distal cleaning end of the luer cleaner assem-
`bly.
`[0007] In a preferred embodiment, the actuation section is
`disposed between the distal cleaning end and the proximally
`disposed fluid reservoir, which preferably is a blister pack.
`The housing includes one or more reservoir-penetrating pro-
`jections or spikes extending proximally toward the reservoir,
`for controllably puncturing the reservoir’s penetrable distal
`wall, permitting cleaning fluid therein to flow through one or
`more openings through the actuation section to the distal luer
`
`cleaning end. A biasing component maintains a spacing
`between the fluid reservoir distal end and the spikes, prevent-
`ing unintentional distal movement of the reservoir during
`shipping and handling. Distally of the fluid reservoir, one or
`more passageways extend from openings adjacent the reser-
`voir to establish fluid communication with the luer-receiving
`cavity in the distal end of the housing. Actuation is brought
`about by axially pressing the proximal end of the fluid reser-
`voir to urge it distally against the spikes which then penetrate
`a distal cover of the reservoir to access the fluid. After actua-
`tion and use of the luer cleaner assembly, it is discarded.
`[0008] Advantages of the present invention include control
`of the puncturing of the reservoir, which preferably is in the
`form of a blister pack, such that the cleaning fluid assuredly
`flows only through the openings created by the spikes of the
`actuation section, and only when the technician intends to use
`the luer cleaner assembly.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`[0009] The accompanying drawings, which are incorpo-
`rated 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:
`[0010] FIG. 1 is an isometric view of the luer cleaner
`assembly of the present invention;
`[0011] FIG. 2 is a cross-sectional view of the luer cleaner
`assembly of FIG. 1;
`[0012] FIG. 3 is an exploded isometric view of the luer
`cleaner assembly of FIGS. 1 and 2;
`[0013] FIG. 4 is an isometric view of the luer cleaner
`assembly of FIGS. 1 to 3 and a luer fitting positioned to be
`inserted thereinto for cleaning thereof; and
`[0014] FIG. 5 is a cross-sectional view of the luer cleaner
`assembly with the luer fitting of FIG. 4 inserted thereinto, and
`the fluid reservoir punctured to access the fluid.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`[0015] In the drawings, like numerals indicate like ele-
`ments 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 simi-
`lar import. The embodiments illustrated below are not
`intended to be exhaustive or to limit the invention to the
`precise form disclosed. These 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.
`[0016] Luer cleaner assembly 100, shown in FIGS. 1 to 3,
`includes a housing having a distal housing portion 102 and a
`proximal housing portion 104 affixed thereto, to which is
`secured a fluid reservoir 160 containing fluid 162 utilized to
`clean a luer fitting. Distal housing portion 102 defines a
`luer-receiving open distal end 106 and houses an array 108,
`preferably, of scrubbers 110. Scrubbers 110 are more particu-
`larly disclosed and discussed in U.S. Patent Publication No.
`2006/0030827 which disclosure is incorporated hereinto by
`reference in that regard, and which function to scrub outer
`surface portions of a luer fitting that is inserted into the open
`
`4
`
`

`

`US 2009/0205151 A1 Aug. 20, 2009
`2
`
`distal end 106. A distal cap 112 is affixed to the distal end of
`distal housing portion 102 to securely retain the array of
`scrubbers within the luer cleaner assembly. It should be noted
`that, in FIG. 2, several scrubbers 110 are not shown, in order
`to clearly show the luer-receiving cavity 124
`[0017] Shown in FIG. 4 is the proximal end of an extension
`tube assembly 192 for a catheter assembly. Assembly 192
`includes an extension tube 194, a clamp 196 such as a Roberts
`clamp disposed therealong, and a luer fitting 190 affixed to the
`proximal end of the extension tube. Luer fitting 190 is seen to
`have a female thread, used to couple the luer fitting and thus
`the catheter assembly, to tubing of medical apparatus such as
`a hemodialysis machine (not shown).
`[0018] Fluid reservoir 160 of the luer cleaner assembly 100
`is preferably a bulbous blister pack containing cleaning fluid
`162 such as an antiseptic like alcohol, preferably isopropyl
`alcohol in a polymer suspension such as polyvinyl alcohol
`and sold commercially by GOJO Industries as PURELL
`(trademark) cleanser, although other fluids may be used such
`as povodine iodine or hydrogen peroxide, or a combination
`thereof. Reservoir 160 includes a distal annular flange 164
`extending radially outwardly, which is seated in a recess 114
`of proximal housing portion 104.
`[0019] Referring now to FIGS. 2 and 3, a collar 116 is
`affixed to the proximal end of proximal housing portion 104
`proximally of distal annular flange 164 of reservoir 160,
`while a biasing component such as a wave washer 118 is
`positioned in recess 114 distally of annular flange 164. Wave
`washer 118 abuts ledge 120 of proximal housing portion 104
`and provides spring bias urging annular flange 164 proxi-
`mally against collar 116 until luer cleaning is to be performed.
`[0020] Also shown in FIG. 2 is a guide member 122 extend-
`ing distally toward open distal end 106 centrally disposed in
`luer-receiving cavity 124, adapted to be received into the
`central opening of the luer fitting during cleaning of the luer
`fitting, stabilizing and centering the luer fitting during scrub-
`bing. Scrubbing elements of the scrubbers 110 extend radially
`inwardly toward guide member 122. At least one, and pref-
`erably a plurality of first passageways 126 are defined in the
`transverse wall 128 at the proximal end of the luer-receiving
`cavity 124, extending from luer-receiving cavity 124 proxi-
`mally toward proximal housing portion 104 and fluid reser-
`voir 160, which will be described below.
`[0021] Proximal housing portion 104 includes a transverse
`wall 130 which defines ledge 120 that supports wave washer
`118. Projecting proximally from transverse wall 130 is at
`least one, and preferably a plurality of sharply pointed pro-
`jections or spikes 132. As shown in FIG. 5, spikes 132 serve
`to penetrate and puncture the distal cover of the fluid reservoir
`160 when the luer cleaner is activated to clean a luer fitting
`inserted into its open distal end and the reservoir 160 is
`pressed distally against the spring bias of wave washer 118.
`Second passageways 134 are in fluid communication with
`first passageways 126, and extend proximally through trans-
`verse wall 130. Fluid 162 escaping from now-punctured res-
`ervoir 160 is pressed into second passageways 134 and flows
`through first passageways 126 and into luer-receiving cavity
`124 and also into additional channels defined in the scrubbers
`
`110 to eventually coat the luer fitting in luer-receiving cavity
`124 for cleaning thereof, as described in U.S. Patent Publica-
`tion 2006/0030827. Reservoir 160 is pressed and crushed
`after puncturing to express substantially all cleaning fluid
`therefrom and into the luer-receiving cavity 124.
`[0022] The luer cleaner of the present invention incorpo-
`rates a self-contained penetration system for penetrating the
`fluid reservoir to access the cleaning fluid when desired, for
`the cleaning of a luer fitting inserted into the assembly. The
`present invention also provides that inadvertent puncturing of
`the reservoir is avoided.
`[0023] 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 assembly for cleaning a luer fitting
`inserted thereinto, comprising:
`a housing having an open distal end and further having a
`fluid reservoir secnred to a proximal end thereof, the
`housing defining a luer-receiving cavity within which
`are contained scrubber components adapted to scrub
`outer surfaces of a luer fitting inserted into the luer-
`receiving cavity to be cleaned, and also defining at least
`one passageway extending from an opening adjacent the
`fluid reservoir and in fluid communication with the luer-
`receiving cavity,
`the housing further including at least one reservoir-pen-
`etrating projection distally of the fluid reservoir and
`extending proximally theretoward and also including a
`biasing component disposed between the housing and
`the fluid reservoir maintaining the fluid reservoir spaced
`proximally from the at least one reservoir-penetrating
`projection, yet enabling the fluid reservoir to be urged
`distally against spring bias when desired during luer
`fitting cleaning such that the at least one reservoir-pen-
`etrating projection penetrates a distal cover of the fluid
`reservoir thus accessing the cleaning fluid which then
`flows distally through the at least one passageway into
`the luer-receiving cavity.
`2. The luer cleaner assembly of claim 1, wherein a proxi-
`mal collar secures the fluid reservoir to the proximal end of
`the housing.
`3. The luer cleaner assembly of claim 1, wherein the bias-
`ing component is a wave washer.
`4. The luer cleaner assembly of claim 1, wherein the hous-
`ing includes a plurality of passageways.
`5. The luer cleaner assembly of claim 1, wherein the hous-
`ing includes a plurality of reservoir-penetrating proj ections.
`6. The luer cleaner assembly of claim 5, wherein the hous-
`ing includes a like plurality of passageways associated with
`respective ones of the plurality of reservoir-penetrating
`projections.
`
`5
`
`