I 1111111111111111 11111 1111111111 1111111111 1111111111 111111111111111 IIII IIII
`US008740864B2
`
`c12) United States Patent
`Hoang et al.
`
`(IO) Patent No.:
`(45) Date of Patent:
`
`US 8,740,864 B2
`Jun.3,2014
`
`(54) PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER
`
`(75)
`
`Inventors: Minh Quang Hoang, Sandy, UT (US);
`Jonathan Karl Burkholz, Salt Lake
`City, UT (US)
`
`(73) Assignee: Becton, Dickinson and Company,
`Franklin Lakes, NJ (US)
`
`( *) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 1701 days.
`
`(21) Appl. No.: 11/281,711
`
`(22) Filed:
`
`Nov. 17, 2005
`
`(65)
`
`Prior Publication Data
`
`US 2007 /0112333 Al
`
`May 17, 2007
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61M25/00
`A61M25/16
`A61M25/18
`A61M39/00
`A61M39/10
`(52) U.S. Cl.
`USPC ........................................... 604/267; 604/533
`( 58) Field of Classification Search
`USPC ............... 604/265, 267, 533-537; 15/104.03,
`15/104.062, 104.92, 104.93, 104.94;
`422/28
`See application file for complete search history.
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`2,961,682 A *
`4,280,632 A
`4,282,891 A *
`4,354,490 A *
`
`11/1960 Wurmbock et al.
`7/1981 Yuhara
`132/73.5
`8/1981 Duceppe .
`10/ 1982 Rogers .......................... 604/403
`
`15/104.94
`
`4,432,764 A * 2/1984
`Lopez ........................... 604/533
`4,440,207 A * 4/1984
`Genatempo et al.
`150/154
`4,444,310 A
`4/1984
`Odell
`4,624,664 A * 11/1986
`Peluso et al. .................. 604/256
`4,626,664 A
`12/1986
`Grise
`4,655,762 A * 4/1987
`Rogers .......................... 604/403
`4,671,306 A * 6/1987
`Spector .
`132/73
`4,778,447 A * 10/1988
`Velde et al. ..................... 604/29
`4,991,629 A
`2/1991
`Ernesto et al.
`5,195,957 A * 3/1993
`Tollini ............................ 604/29
`5,242,425 A * 9/1993
`White et al.
`.................. 604/256
`5,334,388 A * 8/1994
`Hoang et al. .................. 424/402
`5,547,662 A
`8/1996
`Khan et al.
`5,554,135 A * 9/1996
`Menyhay ...................... 604/256
`5,639,310 A * 6/1997
`134/6
`Giampaolo, Jr.
`5,694,978 A * 12/1997
`Heilmann et al.
`138/89
`5,706,944 A
`1/1998
`Hoang et al.
`5,792,120 A * 8/1998
`Menyhay ...................... 604/256
`5,817,344 A * 10/1998
`Hoang et al. .................. 424/667
`5,954,957 A
`9/1999
`Chin-Loy et al.
`6,045,539 A * 4/2000
`Menyhay ...................... 604/256
`6,116,468 A
`9/2000
`Nilson
`6,117,114 A * 9/2000
`Paradis ......................... 604/246
`5/2001
`6,227,391 Bl
`King
`6,708,363 B2 * 3/2004
`15/104.92
`Larsen
`6,911,025 B2 * 6/2005
`Miyahara ...................... 604/415
`(Continued)
`
`Primary Examiner - Kevin C Sirmons
`Assistant Examiner - Andrew Gilbert
`(74) Attorney, Agent, or Firm -Jeanne Lukasavage; Craig
`Metcalf; Kirton McConkie
`
`ABSTRACT
`(57)
`Cap and cleaning devices antiseptically maintain patient fluid
`line access valves to minimize the risk of infection via cath(cid:173)
`eters. The devices have a cap that may contain a dry pad
`impregnated with an antimicrobial agent. The cap covers the
`access portion of the access valve when not in use. The
`devices have a hood that contains a wet pad impregnated with
`a cleaning solution and, optionally, an antimicrobial agent.
`The wet pad cleans the access portion of the access valve prior
`to and optionally, after the access valve is utilized to access
`the patient fluid line.
`
`19 Claims, 7 Drawing Sheets
`
`74~
`
`7 8 ~
`
`18
`
`78a
`
`80
`
`74a
`
`BAXTER EXHIBIT 1020
`Page 1 of 14
`
`

`

`US 8,740,864 B2
`Page 2
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`6,994,315 B2 *
`2/2006 Ryan et al. ................. 251/149.6
`7,083,605 B2 *
`8/2006 Miyahara ...................... 604/415
`7,198,611 B2 *
`4/2007 Connell et al. .................. 604/30
`7,452,349 B2 * 11/2008 Miyahara ...................... 604/415
`7,682,561 B2 *
`3/2010 Davis et al. ..................... 422/28
`7,704,935 Bl*
`4/2010 Davis et al. ................... 510/131
`7,922,701 B2 *
`4/2011 Buchman ...................... 604/256
`8,065,773 B2 * 11/2011 Vaillancourt et al.
`15/104.94
`8,113,731 B2 *
`2/2012 Cable et al. ................... 401/134
`2003/0153865 Al*
`8/2003 Connell et al. .................. 604/28
`2004/0004019 Al *
`1/2004 Busch ........................... 206/571
`2004/0258560 Al* 12/2004 Lake et al.
`...................... 422/28
`
`2005/0124970 Al*
`2005/0147524 Al
`2006/0030827 Al *
`2007 /0202177 Al *
`2007 /0225660 Al *
`2008/0027399 Al *
`2008/0147047 Al *
`2008/0177250 Al *
`2009/00287 50 Al *
`2009/0062766 Al*
`2009/0149819 Al *
`2010/0047123 Al
`2010/0049170 Al
`2012/0039765 Al
`
`6/2005 Kunin eta!. .................. 604/508
`7/2005 Bousquet
`2/2006 Raulerson et al. ............ 604/267
`8/2007 Hoang .......................... 424/486
`9/2007 Lynn ............................. 604/265
`1/2008 Harding et al . ............... 604/265
`6/2008 Davis et al . ................... 604/533
`7/2008 Howlett et al.
`............... 604/533
`1/2009 Ryan ............................... 422/28
`3/2009 Howlett et al.
`............... 604/411
`6/2009 Chelak .......................... 604/246
`2/2010 Solomon et al.
`2/2010 Solomon et al.
`2/2012 Solomon et al.
`
`* cited by examiner
`
`BAXTER EXHIBIT 1020
`Page 2 of 14
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`

`

`U.S. Patent
`
`Jun.3,2014
`
`Sheet 1 of 7
`
`US 8,740,864 B2
`
`m
`
`0
`N
`
`(X)
`<{
`
`.....
`N
`
`(0
`
`.....
`
`BAXTER EXHIBIT 1020
`Page 3 of 14
`
`

`

`U.S. Patent
`
`Jun.3,2014
`
`Sheet 2 of 7
`
`US 8,740,864 B2
`
`FIG. 2
`
`16
`
`FIG. 3
`
`16
`
`20
`
`14b
`
`18
`
`A6
`
`A8
`
`BAXTER EXHIBIT 1020
`Page 4 of 14
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`

`

`U.S. Patent
`
`Jun.3,2014
`
`Sheet 3 of 7
`
`US 8,740,864 B2
`
`FIG. 4
`
`18
`
`16a
`
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`Page 5 of 14
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`

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`U.S. Patent
`
`Jun.3,2014
`
`Sheet 4 of 7
`
`US 8,740,864 B2
`
`FIG. 5
`
`40
`
`34
`
`CAP
`
`Clean
`
`36
`
`52
`
`38
`
`54
`
`Cap with
`Cap / Cleaner .-------1
`10a
`
`Cap with
`Clean with
`1 - - -~ alternative 1 - - -~ Cap / Cleaner
`device
`10a
`
`42
`
`46
`
`Clean with
`Cap / Cleaner
`10
`
`Clean with
`Cap / Cleaner
`10a
`
`Cap with
`Cap / Cleaner
`10a
`
`Cap with
`Cap / Cleaner
`10a
`
`Cap with
`Cap / Cleaner
`10b
`
`44
`
`48
`
`50
`
`BAXTER EXHIBIT 1020
`Page 6 of 14
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`

`

`U.S. Patent
`
`Jun.3,2014
`
`Sheet 5 of 7
`
`US 8,740,864 B2
`
`FIG. 6
`
`56~
`
`FIG. 7
`
`64
`
`66
`
`BAXTER EXHIBIT 1020
`Page 7 of 14
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`

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`U.S. Patent
`
`Jun.3,2014
`
`Sheet 6 of 7
`
`US 8,740,864 B2
`
`FIG. 8
`
`58
`
`60
`
`FIG. 9
`
`60
`
`58
`
`70
`
`,....______62
`
`BAXTER EXHIBIT 1020
`Page 8 of 14
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`

`

`U.S. Patent
`
`Jun.3,2014
`
`Sheet 7 of 7
`
`US 8,740,864 B2
`
`FIG. lOA
`
`7 4~
`
`74a
`
`FIG. 10B
`
`78\__
`
`78a
`
`80
`
`BAXTER EXHIBIT 1020
`Page 9 of 14
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`

`

`US 8,740,864 B2
`
`1
`PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER
`
`BACKGROUND OF THE INVENTION
`
`Catheter-related bloodstream infections are caused by bac(cid:173)
`teria/fungi in patients with intravascular catheters. These
`infections are an important cause of illness and excess medi(cid:173)
`cal costs, as approximately 80,000 catheter-related blood(cid:173)
`stream infections occur in U.S. intensive care units each year.
`In addition to the monetary costs, these infections are asso(cid:173)
`ciated with anywhere from 2,400 to 20,000 deaths per year.
`Guidelines from the Centers for Disease Control and Pre(cid:173)
`vention describe various ways to limit catheter-related blood(cid:173)
`stream infections in hospital, outpatient and home care set(cid:173)
`tings. The guidelines address issues such as hand hygiene,
`catheter site care and admixture preparation. Despite these
`guidelines, catheter-related bloodstream infections continue
`to plague our healthcare system.
`Impregnating catheters with various antimicrobial agents
`is one approach that has been implemented to prevent these
`infections. These catheters, however, have given less than
`satisfactory results. In addition, some microbes have devel(cid:173)
`oped resistance to the various antimicrobial agents in the
`system.
`In another system that is commercially available in Europe,
`a catheter hub containing an antiseptic chamber is filled with
`three percent iodinated alcohol. Though it has shown to be
`effective, the catheter hub is expensive and does not fare as
`well in a formal cost-benefit analysis. Therefore, there is a
`need for an effective and inexpensive way to reduce the num-
`ber of catheter-related infections.
`
`BRIEF SUMMARY OF THE INVENTION
`
`The present invention is a device for antiseptically main(cid:173)
`taining a patient fluid line access valve. The device includes a
`housing for covering the access portion of the access valve. A
`pad within the housing contacts the surface of the access
`portion of the access valve prior to (and optionally after)
`accessing the patient fluid line via the access valve to reduce
`the amount of microbes on the valve's access portion.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 is an exploded view ofa first representative embodi(cid:173)
`ment of a cap/cleaner device and a patient fluid line access
`valve.
`FIG. 2 is a cross-sectional side view of the first represen(cid:173)
`tative embodiment of the cap/cleaner device.
`FIG. 3 is a cross-sectional side view of the first cap/cleaner
`device capping a patient fluid line access valve.
`FIG. 4 is a cross-sectional side view of the first cap/cleaner
`device cleaning a patient fluid line access valve.
`FIG. 5 is a flow chart illustrating representative embodi(cid:173)
`ments of methods of using the cap/cleaner device.
`FIG. 6 is a perspective view of a second representative
`embodiment of a cap/cleaner device.
`FIG. 7 is a cross-sectional side view of the second cap/
`cleaner device.
`FIG. 8 is a cross-sectional view of a first separable connec-
`tor.
`FIG. 9 is a side view of a second separable connector.
`FIG. l0A is a cross-sectional view of cleaning device.
`FIG. l0B is a cross-sectional view of a capping device.
`
`DETAILED DESCRIPTION
`
`FIG. 1 shows an exploded view of patient fluid line access
`valve cap/cleaner device 10 with patient fluid line access
`
`10
`
`30
`
`2
`valve A and patient fluid line B. Cap/cleaner 10 includes
`housing 12 with cap end 14, cleaning end 16 and thread 18;
`and lid 20. Access valve A includes housing A2 with thread
`A4 and septum A6 with slit AS. The exposed surface of
`5 septumA6 along with at least a portion of the exposed surface
`ofhousingA2 that surrounds septumA6, form access portion
`Al0 of access valve A. Line B may be any of a number of
`types that include, for example, intravascular (IV) lines and
`catheters, saline wells, arterial lines and hemodialysis lines.
`As will be described in more detail below, cap end 14 of
`cap/cleaner 10 attaches to access portion AlO of access valve
`A. Housing 12 is made from any of a number of types of
`plastic materials such as polycarbonate, polypropylene, poly-
`15 ethylene, glycol-modified polyethylene terephthalate, acry(cid:173)
`lonitrile butadiene styrene or any other moldable plastic
`material used in medical devices.
`Cap end 14 of housing 12 is open and contains thread 18
`along the inside of the opening. Cleaning end 16 is covered by
`20 lid 20. Lid20 is typically made of foil or similar type material
`and completely seals the opening (not shown) of cleaning end
`16. Any type of material or seal may be used as long as a
`moisture barrier is provided.
`FIG. 2 shows cap/cleaner 10 in more detail. In addition to
`25 the structures shown in FIG. 1, cap/cleaner 10 also includes
`internal wall 12a, hood 16a and chamber 16b of cleaning end
`16, cap 14a and cavity 14b of cap end 14, wet pad 22 within
`chamber 16b and dry pad 24 within cavity 14b. Internal wall
`12a separates cap end 14 and cleaning end 16.
`Cap/cleaner 10 is typically distributed and stored in aster-
`ile, sealed package either alone or paired with a patient fluid
`line access valve. One such type of valve is the BD Q-Syte™
`valve from Becton, Dickinson and Company (illustrated in
`FIG. 1). However, cap/cleaner 10 is useful with any type of
`35 needleless or needle-required access valve. Once removed
`from the package, cap/cleaner 10 is ready for use.
`FIG. 3 illustrates cap/cleaner 10 covering access portion
`Al O of access valve A. SeptumA6 provides an accessible seal
`for either a needle or a male luer taper. In the case of a
`40 needleless access device, such as that shown in FIG. 3, slit AS
`extends through septum A6 to provide a port for insertion of
`the male luer taper.
`As shown, cap end 14 includes cap 14a with cavity 14b,
`which contains dry pad 24. Dry pad 24 is impregnated with an
`45 antimicrobial agent to aid in maintaining antiseptic condi(cid:173)
`tions of access portion Al O of valve A. Suitable material for
`dry pad 24 includes non-woven material or a foam sponge pad
`made of polyurethane, polyester, cotton or any bioengineered
`plastic material such as silicone. Any of a number of antimi-
`50 crobial agents may be used to impregnate dry pad 24. Some
`examples include chlorhexidine gluconate, chlorhexidine
`diacetate, chloroxylenol, povidone iodine, Triclosan, benze(cid:173)
`thonium chloride, benzalkonium chloride, octenidine, antibi(cid:173)
`otic, etc. Alternatively, cap end 14 does not contain dry pad 24
`55 and aids in maintaining antiseptic conditions by simply cov(cid:173)
`ering access portion AlO.
`In use, cap end 14 of cap/cleaner 10 is placed over access
`portion Al 0 such that access portion Al 0 is within cavity 14b
`of cap end 14. Cap/cleaner 10 may be attached either prior to
`60 or after placement of valve A for the patient. As shown in FIG.
`3, valve A includes threadA4. By rotating cap/cleaner 10 or
`valve A relative to one another, threads A4 and 18 ( of cap/
`cleaner 10) interlock to provide a secured attachment. It is not
`necessary, however, for valve A to include thread A 4. Cap end
`65 14 will also attach and hold a luer slip, which does not have a
`thread. In other embodiments, cap/cleaner 10 may be manu(cid:173)
`factured without a thread.
`
`BAXTER EXHIBIT 1020
`Page 10 of 14
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`

`US 8,740,864 B2
`
`3
`The amount of material used for dry pad 24 can vary.
`Typically, there is enough material for dry pad 24 to contact at
`least septum A6 of valve A. Enough space should be left in
`cavity 14b of cap end 14 for access portionAlO of valve A to
`be encompassed by cap end 14, thus, maintaining antiseptic 5
`conditions of the surface. By maintaining antiseptic condi(cid:173)
`tions of the surface, the risk of microbes penetrating into
`valve A is minimized.
`To further minimize the opportunity for penetration by
`microbes, access portion AlO is cleaned prior to accessing 10
`valve A with a needle or male luer taper. FIG. 4 illustrates
`cap/cleaner 10 cleaning access portion Al O of valve A.
`As shown in FIG. 4, cleaning end 16 includes hood 16a and
`chamber 16b, which contains wet pad 22. Wet pad 22 is
`impregnated with a cleaning agent and optionally, an antimi- 15
`cro bial agent. Wet pad 22 may be made from materials similar
`to those described for dry pad 24.
`The cleaning solution is typically an alcohol- or water(cid:173)
`based solution. A suitable alcohol-based solution contains
`about 50% to about 100% (no additional water) of an alcohol 20
`solution. The balance of solutions that are less than 100%
`alcohol contain water and other optional materials such as
`fragrance, dye, surfactant, emollient, etc.
`Suitable water-based solutions contain about 1 % to about
`10% alcohol solvent as a wetting agent and about 90% to
`about 99% water. Again, optional materials may also be
`added such fragrance, dye, surfactant, emollient, etc.
`In an alternative embodiment, the cleaning solution also
`includes an antimicrobial agent. Any of a number of antimi(cid:173)
`crobial agents may be used in wet pad 22. Some examples
`include chlorhexidine gluconate, chlorhexidine diacetate,
`chloroxylenol, povidone iodine, Triclosan, benzethonium
`chloride, benzalkonium chloride, octenidine, antibiotic, etc.
`Wet pad 22 and dry pad 24 may be impregnated with the same
`or different antimicrobial agents.
`As shown in the Figures, cleaning end 16 is larger than cap
`end 14. The hood of cleaning end 16 loosely encompasses at
`least access portion Al O of valve A, and chamber 16b is sized
`to allow some movement when access portionAlO is inserted.
`The amount of material used for wet pad 22 will vary, but the
`amount should hold enough cleaning solution and allow
`enough movement for thorough cleaning. Wet pad 22 should
`be contained entirely within hood 16a such that it is recessed
`inside chamber 16b of cleaning end 16.
`In preparation for accessing valve A, cap end 14 is removed
`from valve A either by rotating cap/cleaner 10 to release
`threads 18 and A4 or by simply pulling if valve A does not
`have a thread. Lid 20 is removed from cleaning end 16.
`Cleaning end 16 is then placed over at least access portion
`AlO, such that wet pad 22 contacts septumA6. Though FIG. 50
`4 only shows contact with septum A6, additional pressure
`may be applied such that wet pad 22 extends beyond the edges
`of septum A6 to contact portions of the exposed surface of
`housingA2.
`Next, for thorough cleaning, wet pad 22 should scrub 55
`access portion AlO of valve A. Scrubbing may be accom(cid:173)
`plished by, for example, rotational movement or back and
`forth movement. Scrubbing should be carried out for a time
`long enough to allow the cleaning solution to at least disinfect
`access portion Al O of valve A.
`Once cleaned, valve A is ready to use. A needle or male luer
`taper is inserted to either infuse or withdraw fluid from the
`patient fluid line.
`FIG. 5 is a flowchart illustrating representative embodi(cid:173)
`ments of methods for using cap/cleaner 10. Capping step 34, 65
`cleaning step 36 and accessing step 38 were described above
`and are the same in each embodiment. However, upon with-
`
`4
`drawal after accessing the patient fluid line, access portion
`Al O of valve A may either be immediately capped or cleaned
`again prior to capping. If immediately capped, a new, second
`cap/cleaner 10a is obtained and removed from its package.
`This is represented by step 40. Cap end 14 of cap/cleaner 10a
`is placed over access portionAlO as described above. Clean-
`ing end 16 of cap/cleaner 10a is sealed and ready for the next
`time valve A is utilized.
`Alternatively, access portion AlO may be cleaned again
`prior to capping. This can be performed in one of the follow(cid:173)
`ing ways. First, in step 42, cleaning end 16 of cap/cleaner 10
`is reused to clean access portion Al 0, which is then capped, at
`step 44, with cap end 14 of a new, second cap/cleaner lOa.
`Second, in step 46, cleaning end 16 of a new, second cap/
`cleaner 10a is used to clean access portion Al 0. Then, valve
`A may be capped either with cap end 14 of cap/cleaner 10a
`(step 48) orofanew, third cap/cleaner 10b (step 50). Third, in
`step 52, access portion AlO may be cleaned with an alterna(cid:173)
`tive disposable cleaning device that is well known in the art.
`Examples of such cleaning devices include alcohol wipes,
`iodine swabs, etc. Once cleaned, cap end 14 of a new, second
`cap/cleaner lOa may be attached to valve 26 (step 50).
`Additional embodiments of the present invention include
`separable and individual, uncoupled devices. FIG. 6 shows
`25 separable cap/cleaner 56. Separable cap/cleaner 56 includes
`cap end 58, cleaning end 60 and gap 62. Gap 62 is the sepa(cid:173)
`ration between cap end 58 and cleaning end 60.
`FIG. 7 shows separable cap/cleaner 56 in more detail and
`further includes dry pad 64 within cap end 58, wet pad 66
`30 within cleaning end 60 and breakable connector 68. In use,
`separable cap/cleaner 56 operates as described above for cap/
`cleaner 10 except that cleaning end 60 may be removed after
`cleaning access portion Al O of valve A. Detaching cleaning
`end 60 reduces bulkiness from separable cap/cleaner 56 by
`35 only maintaining cap end 58 over access portion Al 0.
`FIG. 8 shows a representative embodiment of breakable
`connector 68. Connector 68 is typically made of the same
`material from which housing 12 is fabricated. Torsional
`shearing caused by twisting cap end 58 and/or cleaning end
`40 60 relative to each other may be used to break connector.
`Alternatively, a three-point bending force, which consists of a
`fulcrum (connector 68) that directs a force vector contralat(cid:173)
`eral to the direction of the terminal ( cap end 58 and cleaning
`end 60) force vectors, may be applied for breaking connector
`45 68. Once removed, cleaning end 60 may be discarded.
`FIG. 9 is an alternate embodiment showing notched break(cid:173)
`able connector 70. Notch 72 within connector 70 is an area of
`reduced cross-sectional area, which acts as a score to facili(cid:173)
`tate breaking of connector 70.
`Other separation mechanisms may also be used to remove
`cleaning end 60 from cap end 58. For instance, a luer lock type
`mechanism can be utilized to separate ends 58 and 60 from
`each other.
`FIG. lOA shows a representative embodiment of cleaning
`device 74 with lid 74a and wet pad 76. Here, cleaning device
`74 is a stand-alone device that is used as described above for
`cleaning end 16.
`FIG. 10B shows a representative embodiment of cap
`device 78 with lid 78a and pad 80. Cap device 78 is a stand-
`60 alone device where pad 80 may either be a wet pad or a dry
`pad. Where pad 80 is a dry pad, cap device 78 is used as
`described above for cap end 14.
`Where pad 80 is a wet pad, cap device 78 may be used to
`clean access portionAl0 of valve A in addition to its capping
`function. The twisting motion involved in removing and plac(cid:173)
`ing cap device 78 with respect to access potionAl0 provides
`friction for cleaning. Additional cleaning can be accom-
`
`BAXTER EXHIBIT 1020
`Page 11 of 14
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`US 8,740,864 B2
`
`10
`
`15
`
`20
`
`5
`plished by twisting cap device 78 in one direction and then in
`the reverse direction for a desired amount of time.
`Cap device 78 further comprises an inner circumference 82
`that defines a cavity in which pad 80 is housed. In some
`instances, cap device 78 comprises a thread or threading 18 5
`having a length that is less than inner circumference 82.
`With either cleaning device 7 4 or cap device 78, additional
`gripping surface may be added by extending the length of the
`housing. The increased gripping surface would provide easier
`handling of devices 74 and 78.
`Cap/cleaner 10 cleans and maintains access valves in anti(cid:173)
`septic or aseptic condition. This substantially decreases the
`risk of patient infections caused by the ingress of microbes
`into the access valves, particularly for needleless access
`valves.
`Although the present invention has been described with
`reference to preferred embodiments, workers skilled in the art
`will recognize that changes may be made in form and detail
`without departing from the spirit and scope of the invention.
`The invention claimed is:
`1. A device for maintaining a patient fluid line access valve
`having an access portion with an end face that includes a
`septum and external threads on the access portion proximate
`the septum, the device comprising:
`a housing having an opening to an inner cavity for receiv- 25
`ing the access portion of the patient fluid line access
`valve;
`a wet pad holding a cleaning solution prior to receiving the
`access portion of the patient fluid line access valve;
`threading protruding inwardly into the inner cavity from an 30
`inner wall of the housing near the opening, the threading
`to engage the external threads of the access portion of the
`patient fluid line access valve as the housing is placed
`over the access portion of the patient fluid line access
`valve to contact the wet pad with the end face of the 35
`access portion of the patient fluid line access valve, and
`to disinfect the end face and at least a portion of the
`external threads of the access portion of the patient fluid
`line access valve with the cleaning solution from the wet
`pad, wherein the threading threadedly receives the exter- 40
`nal threads thereby causing the end face to advance into
`the inner cavity such that the septum contacts the wet
`pad;and
`a removable lid attached to the opening of the housing
`enclosing the inner cavity to seal inner cavity and to 45
`maintain the wet pad and cleaning solution in the inner
`cavity prior to receiving the access portion of the patient
`fluid line access valve.
`2. The device of claim 1, wherein the inner cavity com(cid:173)
`prises an inner circumference and the threading comprises a 50
`length that is less than the inner circumference.
`3. The device of claim 1, wherein a threaded interaction
`between the threading and the external threads provides
`adjustable positioning of the septum within the inner cavity.
`4. The device of claim 3, wherein adjustable positioning of 55
`the septum within the inner cavity allows the septum to con(cid:173)
`tact the wet pad, and further allows the septum to contact and
`compress the wet pad between the septum and the inner
`cavity.
`5. The device of claim 1, wherein the wet pad is a sponge. 60
`6. The device of claim 1, wherein the housing comprises a
`polyethylene or polypropylene material.
`7. The device of claim 1, wherein the cleaning solution
`comprises an antimicrobial agent.
`8. The device of claim 7, wherein the antimicrobial agent 65
`comprises at least one of chlorhexidine gluconate and chlo(cid:173)
`rhexidine diacetate.
`
`6
`9. The device of claim 7, wherein the cleaning solution is an
`alcohol-based cleaning solution.
`10. A device for maintaining a patient fluid line access
`valve having an access portion with an end face that includes
`a septum and external threads on the access portion proximate
`the septum, the device comprising:
`a housing for covering the access portion of the patient
`fluid line access valve, the housing having an open end,
`a closed end, and a cavity, the housing including a thread
`on an inner wall of the cavity for engaging the external
`threads on the access portion of the patient fluid line
`access valve;
`a wet pad impregnated with a cleaning solution prior to
`attachment of the housing to the access portion of the
`patient fluid line access valve, the wet pad being posi(cid:173)
`tioned within the cavity for contacting the end face to
`disinfect the end face and at least a portion of the exter(cid:173)
`nal threads of the access portion of the patient fluid line
`access valve when the housing is positioned over and
`covers the access portion; and
`a lid over the open end of the housing to seal the cavity with
`the wet pad within the cavity and provide a moisture
`barrier, the lid being removable to expose the wet pad
`and allow insertion of the access portion of the patient
`fluid line access valve into the cavity so that the end face
`of the access portion contacts the wet pad.
`11. The device of claim 10, wherein the cavity comprises
`an inner circumference and the thread comprises a length that
`is less than the inner circumference.
`12. The device of claim 10, wherein the cleaning solution
`comprises an antimicrobial agent.
`13. The device of claim 12, wherein the antimicrobial agent
`comprises at least one of chlorhexidine gluconate and chlo(cid:173)
`rhexidine diacetate.
`14. The device of claim 12, wherein the cleaning solution is
`an alcohol-based cleaning solution.
`15. A device for maintaining a threaded patient fluid line
`access valve, the device comprising:
`a housing having an inner cavity for covering an end face of
`the threaded patient fluid line access valve;
`a wet pad within the housing and impregnated with a clean(cid:173)
`ing solution prior to contacting the threaded patient fluid
`line access valve, the wet pad being configured to con(cid:173)
`tact at least a portion of the threaded patient fluid line
`access valve and the end face of the threaded patient fluid
`line access valve to disinfect the end face and at least a
`portion of an external thread of the threaded patient fluid
`line access valve;
`an internal thread within the inner cavity of the housing and
`positioned close to the wet pad for engaging the external
`thread of the threaded patient fluid line access valve,
`whereby rotational movement of the external thread
`with respect to the internal thread causes the end face to
`advance into the inner cavity such that a septum of the
`end face contacts the wet pad; and
`a lid providing a moisture barrier for the wet pad and the
`cleaning solution prior to contact between the wet pad
`and the threaded patient fluid line access valve, the lid
`being removable to allow the end face of the threaded
`patient fluid line access valve to be inserted into the
`housing and contact the wet pad.
`16. The device of claim 15, wherein the inner cavity com(cid:173)
`prises an inner circumference and the internal thread com(cid:173)
`prises a length that is less than the inner circumference.
`17. The device of claim 15, wherein the wet pad is a sponge.
`18. The device of claim 15, wherein the housing comprises
`a polyethylene or polypropylene material.
`
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`Page 12 of 14
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`

`

`US 8,740,864 B2
`
`7
`19. The device of claim 15, wherein the cleaning solution is
`an alcohol-based cleaning solution.
`* * * * *
`
`8
`
`BAXTER EXHIBIT 1020
`Page 13 of 14
`
`

`

`UNITED STATES PATENT AND TRADEMARK OFFICE
`CERTIFICATE OF CORRECTION
`
`PATENT NO.
`APPLICATION NO. :
`DATED
`INVENTOR(S)
`
`8,740,864 B2
`11/281711
`June 3, 2014
`Hoang et al.
`
`Page 1 of 1
`
`It is certified that error appears in the above-identified patent and that said Letters Patent is hereby corrected as shown below:
`
`On the Title Page:
`
`The first or sole Notice should read --
`
`Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b)
`by 1834 days.
`
`Signed and Sealed this
`Thirtieth Day of May, 2017
`
`Michelle K. Lee
`Director of the United States Patent and Trademark Office
`
`BAXTER EXHIBIT 1020
`Page 14 of 14
`
`