I 1111111111111111 1111111111 111111111111111 IIIII IIIII IIIII 111111111111111111
`US010335584B2
`
`c12) United States Patent
`Hoang et al.
`
`(IO) Patent No.: US 10,335,584 B2
`(45) Date of Patent:
`*Jul. 2, 2019
`
`(54) PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER
`
`(71) Applicant: Becton, Dickinson and Company,
`Franklin Lakes, NJ (US)
`
`(72)
`
`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 671 days.
`
`EP
`EP
`
`This patent is subject to a terminal dis(cid:173)
`claimer.
`
`(58) Field of Classification Search
`CPC .. A61M 39/162; A61M 39/165; A61M 39/16;
`A61M 39/20
`See application file for complete search history.
`
`(56)
`
`References Cited
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`(Continued)
`
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`1 649 890 Al
`6/2013
`2 606 930 Al
`(Continued)
`
`OTHER PUBLICATIONS
`
`(21) Appl. No.: 15/041,939
`
`(22) Filed:
`
`Feb. 11, 2016
`
`(65)
`
`Prior Publication Data
`
`US 2016/0158521 Al
`
`Jun. 9, 2016
`
`Related U.S. Application Data
`
`(63) Continuation of application No. 14/159,959, filed on
`Jan. 21, 2014, now Pat. No. 9,283,367, which is a
`(Continued)
`
`(51)
`
`Int. Cl.
`A61M 39/16
`A61M 39102
`
`(2006.01)
`(2006.01)
`(Continued)
`
`(52) U.S. Cl.
`CPC .......... A61M 39/162 (2013.01); A61M 39102
`(2013.01); A61M 39/16 (2013.01);
`(Continued)
`
`"Corrected Petition for Inter Partes Review Under 35 U.S.C.
`.sctn .. sctn. 311-319 and 37 C.F.R .. sctn. 42,100 et seq.," USPTO,
`Patent Trial and Appeal Board, Excelsior Medical Corporation v.
`Becton, Dickinson and Company, Case IPR2014-00880, U.S. Pat.
`No. 8,740,864, pp. 1-48, Jun. 23, 2014.
`(Continued)
`
`Primary Examiner - Andrew M Gilbert
`(74) Attorney, Agent, or Firm - Dickinson Wright, PLLC
`ABSTRACT
`(57)
`Cap and cleaning devices antiseptically maintain patient
`fluid line access valves to minimize the risk of infection via
`catheters. 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.
`18 Claims, 7 Drawing Sheets
`
`20
`
`14
`
`A2
`
`A
`
`12 \ 10
`
`16
`
`AB
`
`A4
`
`BAXTER EXHIBIT 1001
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`

`US 10,335,584 B2
`Page 2
`
`Related U.S. Application Data
`
`continuation of application No. 11/281,711, filed on
`Nov. 17, 2005, now Pat. No. 8,740,864.
`
`(51)
`
`(2006.01)
`(2006.01)
`(2006.01)
`
`Int. Cl.
`A61M 39/20
`A61M 39/04
`A61M 39/10
`(52) U.S. Cl.
`CPC ........... A61M 39/20 (2013.01); A61M 39/045
`(2013.01); A61M 2039/1033 (2013.01); A61M
`2039/1072 (2013.01); Yl0T 137/4259
`(2015.04)
`
`(56)
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`BAXTER EXHIBIT 1001
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`US 10,335,584 B2
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`
`* cited by examiner
`
`BAXTER EXHIBIT 1001
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`U.S. Patent
`
`Jul. 2, 2019
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`Sheet 1 of 7
`
`US 10,335,584 B2
`
`m
`
`(X)
`<(
`
`N ..-
`
`co
`..-
`
`0
`N
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`BAXTER EXHIBIT 1001
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`U.S. Patent
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`Jul. 2, 2019
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`Sheet 2 of 7
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`US 10,335,584 B2
`
`FIG. 2
`
`16
`
`FIG. 3
`
`16
`
`20
`
`14b
`
`18
`
`A6
`
`A8
`
`BAXTER EXHIBIT 1001
`Page 5 of 14
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`U.S. Patent
`
`Jul. 2, 2019
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`Sheet 3 of 7
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`US 10,335,584 B2
`
`FIG. 4
`
`18
`
`BAXTER EXHIBIT 1001
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`U.S. Patent
`
`Jul. 2, 2019
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`Sheet 4 of 7
`
`US 10,335,584 B2
`
`FIG. 5
`
`40
`
`34
`
`CAP
`
`Clean
`
`36
`
`52
`
`38
`
`54
`
`Cap with
`Cap I Cleaner - - -
`10a
`
`Cap with
`Clean with
`- -~ alternative 1 - - -~ Cap / Cleaner
`10a
`device
`
`42
`
`46
`
`Clean with
`Cap / Cleaner
`10
`
`Clean with
`Cap / Cleaner
`10a
`
`Cap with
`Cap / Cleaner
`10a
`
`Cap with
`Cap I Cleaner
`10a
`
`Cap with
`Cap / Cleaner
`10b
`
`44
`
`48
`
`50
`
`BAXTER EXHIBIT 1001
`Page 7 of 14
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`U.S. Patent
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`Jul. 2, 2019
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`Sheet 5 of 7
`
`US 10,335,584 B2
`
`FIG. 6
`
`56~
`
`FIG. 7
`
`64
`
`66
`
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`U.S. Patent
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`Jul. 2, 2019
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`Sheet 6 of 7
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`US 10,335,584 B2
`
`FIG. 8
`
`58
`
`60
`
`FIG. 9
`
`60
`
`58
`
`70
`
`,....._____ 62
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`U.S. Patent
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`Jul. 2, 2019
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`Sheet 7 of 7
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`US 10,335,584 B2
`
`FIG. lOA
`
`74~
`
`74a
`
`FIG. 10B
`
`78~
`
`78a
`
`so---
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`BAXTER EXHIBIT 1001
`Page 10 of 14
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`US 10,335,584 B2
`
`1
`PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER
`
`RELATED APPLICATIONS
`
`5
`
`This application is a continuation of U.S. application Ser.
`No. 14/159,959, filed Jan. 21, 2014, titled PATIENT FLUID
`LINE ACCESS VALVE ANTIMICROBIAL CAP/
`CLEANER, now U.S. Pat. No. 9,283,368, which is a con(cid:173)
`tinuation of U.S. application Ser. No. 11/281,711, filed Nov. 10
`17, 2005, titled PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER, now U.S. Pat. No.
`8,740,864, which are incorporated herein in their entirety.
`
`2
`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
`connector.
`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
`
`BACKGROUND OF THE INVENTION
`
`15
`
`FIG. 1 shows an exploded view of patient fluid line access
`valve cap/cleaner device 10 with patient fluid line access
`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
`20 A4 and septum A6 with slit AS. The exposed surface of
`septum A6 along with at least a portion of the exposed
`surface of housing A2 that surrounds septum A6, form
`access portion Al 0 of access valve A. Line B may be any of
`a number of types that include, for example, intravascular
`25 (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 Al0 of access
`valve A. Housing 12 is made from any of a number of types
`30 of plastic materials such as polycarbonate, polypropylene,
`polyethylene, glycol-modified polyethylene terephthalate,
`acrylonitrile butadiene styrene or any other moldable plastic
`material used in medical devices.
`Cap end 14 of housing 12 is open and contains thread 18
`35 along the inside of the opening. Cleaning end 16 is covered
`by lid 20. Lid 20 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
`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.
`45 Internal wall 12a separates cap end 14 and cleaning end 16.
`Cap/cleaner 10 is typically distributed and stored in a
`sterile, 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
`50 (illustrated in FIG. 1). However, cap/cleaner 10 is useful
`with any type of 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
`55 Al0 of access valve A. Septum A6 provides an accessible
`seal for either a needle or a male luer taper. In the case of a
`needleless access device, such as that shown in FIG. 3, slit
`AS extends through septumA6 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 antimicrobial agent to aid in maintaining antiseptic
`conditions of access portion AlO of valve A. Suitable
`material for dry pad 24 includes non-woven material or a
`65 foam sponge pad made of polyurethane, polyester, cotton or
`any bioengineered plastic material such as silicone. Any of
`a number of antimicrobial agents may be used to impregnate
`
`Catheter-related bloodstream infections are caused by
`bacteria/fungi in patients with intravascular catheters. These
`infections are an important cause of illness and excess
`medical costs, as approximately 80,000 catheter-related
`bloodstream infections occur in U.S. intensive care units
`each year. In addition to the monetary costs, these infections
`are associated with anywhere from 2,400 to 20,000 deaths
`per year.
`Guidelines from the Centers for Disease Control and
`Prevention describe various ways to limit catheter-related
`bloodstream infections in hospital, outpatient and home care
`settings. The guidelines address issues such as hand hygiene,
`catheter site care and admixture preparation. Despite these
`guidelines, 15 catheter-related bloodstream infections con(cid:173)
`tinue 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 40
`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 number 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 of a first representative
`embodiment of a cap/cleaner device and a patient fluid line 60
`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.
`
`BAXTER EXHIBIT 1001
`Page 11 of 14
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`

`US 10,335,584 B2
`
`5
`
`3
`dry pad 24. Some examples include chlorhexidine glucon(cid:173)
`ate, chlorhexidine diacetate, chloroxylenol, povidone iodine,
`Triclosan, benzethonium chloride, benzalkonium chloride,
`octenidine, antibiotic, etc. Alternatively, cap end 14 does not
`contain dry pad 24 and aids in maintaining antiseptic con-
`ditions by simply covering access portion AlO.
`In use, cap end 14 of cap/cleaner 10 is placed over access
`portion Al0 such that access portion Al0 is within cavity
`14b of cap end 14. Cap/cleaner 10 may be attached either
`prior to or after placement of valve A for the patient. As 10
`shown in FIG. 3, valve A includes thread A4. 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 A4. Cap end 14 will also attach and hold a 15
`luer slip, which does not have a thread. In other embodi(cid:173)
`ments, cap/cleaner 10 may be manufactured without a
`thread.
`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 portion AlO of valve
`A to be encompassed by cap end 14, thus, maintaining
`antiseptic conditions of the surface. By maintaining antisep(cid:173)
`tic conditions of the surface, the risk of microbes penetrating
`into valve A is minimized.
`To further minimize the opportunity for penetration by
`microbes, access portion Al0 is cleaned prior to accessing
`valve A with a needle or male luer taper. FIG. 4 illustrates
`cap/cleaner 10 cleaning access portion AlO 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 anti(cid:173)
`microbial 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
`solution. The balance of solutions that are less than 100%
`alcohol contain water and other optional materials such as 40
`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 anti(cid:173)
`microbial 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 encom(cid:173)
`passes at least access portion AlO of valve A, and chamber
`16b is sized to allow some movement when access portion
`Al O 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
`
`4
`16. Cleaning end 16 is then placed over at least access
`portion Al0, such that wet pad 22 contacts septum A6.
`Though FIG. 4 only shows contact with septum A6, addi-
`tional pressure may be applied such that wet pad 22 extends
`beyond the edges of septum A6 to contact portions of the
`exposed surface of housing A2.
`Next, for thorough cleaning, wet pad 22 should scrub
`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 AlO 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,
`cleaning step 36 and accessing step 38 were described above
`and are the same in each embodiment. However, upon
`20 withdrawal 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 lOA is obtained and removed from
`its package. This is represented by step 40. Cap end 14 of
`25 cap/cleaner lOA is placed over access portion Al0 as
`described above. Cleaning end 16 of cap/cleaner l0A is
`sealed and ready for the next time valve A is utilized.
`Alternatively, access portion Al0 may be cleaned again
`prior to capping. This can be performed in one of the
`30 following ways. First, in step 42, cleaning end 16 of cap/
`cleaner 10 is reused to clean access portion Al0, 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 lOA is used to clean access portion
`35 Al0. Then, valve A maybe capped either with cap end 14 of
`cap/cleaner l0A (step 48) or of a new, third cap/cleaner lOB
`(step 50). Third, in step 52, access portion Al0 may be
`cleaned with an alternative 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 1 0A may be attached to
`valve 26 (step 50).
`Additional embodiments of the present invention include
`separable and individual, uncoupled devices. FIG. 6 shows
`45 separable cap/cleaner 56. Separable cap/cleaner 56 includes
`cap end 58, cleaning end 60 and gap 62. Gap 62 is the
`separation 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
`50 within cleaning end 60 and breakable connector 68. In use,
`separable cap/cleaner 56 operates as described above for 10
`cap/cleaner 10 except that cleaning end 60 may be removed
`after cleaning access portion Al0 of valve A. Detaching
`cleaning end 60 reduces bulkiness from separable cap/
`55 cleaner 56 by only maintaining cap end 58 over access
`portion Al0.
`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
`60 shearing caused by twisting cap end 58 and/or cleaning end
`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 contral(cid:173)
`ateral to the direction of the terminal ( cap end 58 and
`65 cleaning end 60) force vectors, may be applied for breaking
`connector 68. Once removed, cleaning end 60 may be
`discarded.
`
`BAXTER EXHIBIT 1001
`Page 12 of 14
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`

`US 10,335,584 B2
`
`5
`FIG. 9 is an alternate embodiment showing notched
`breakable connector 70. Notch 72 within connector 70 is an
`area of reduced cross-sectional area, which acts as a score to
`facilitate breaking of connector 70.
`Other separation mechanisms may also be used to remove 5
`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. l0A 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-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 20
`placing cap device 78 with respect to access potion Al0
`provides friction for cleaning. Additional cleaning can be
`accomplished 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 25
`82 that defines a cavity in which pad 80 is housed. In some
`instances, cap device 78 comprises a thread or threading 18
`having a length that is less than inner circumference 82.
`With either cleaning device 74 or cap device 78, addi(cid:173)
`tional 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
`antiseptic or aseptic condition. This substantially decreases
`the risk of patient infections caused by the ingress of 35
`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 40
`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 a distalmost end face 45
`that includes a septum and external threads on the access
`portion proximate the distalmost end face, the device com(cid:173)
`prising:
`a housing having an inner cavity, wherein an opening to
`the inner cavity is configured for receiving the access 50
`portion of the patient fluid tine access valve;
`a material impregnated with a liquid antimicrobial agent
`prior to receiving the access portion of the patient fluid
`line access valve, wherein the material is disposed in
`the inner cavity;
`threading protruding inwardly into the inner cavity from
`an inner wall of the housing near the opening, the
`threading configured 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 60
`patient fluid line access valve to contact the material
`with the distalmost end face of the access portion of the
`patient fluid line access valve, and configured to dis(cid:173)
`infect the distalmost end face and at least a portion of
`the external threads of the access portion of the patient
`fluid line access valve with the liquid antimicrobial
`agent from the material,
`
`6
`wherein the threading receives the external threads of the
`access portion of the access valve thereby causing the
`distalmost end face to advance into the inner cavity
`such that the septum contacts the material.
`2. The device of claim 1, wherein a threaded interaction
`between the threading and the external threads is configured
`to provide adjustable positioning of the septum within the
`inner cavity.
`3. The device of claim 2, wherein adjustable positioning
`10 of the septum within