(19~ United States
`(12~ Patent Application Publication (lO) Pub. No.." US 2007/0112333 A1
`Hoang et al. (43) Pub. Date: May 17, 2007
`
`US 20070112333A1
`
`(54)
`
`PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER
`
`Publication Classification
`
`(75)
`
`Inventors: Minh Quang Hoang, Sandy, UT (US);
`Jonathan Karl Burkholz, Salt Lake
`City, UT (US)
`
`Correspondence Address:
`BECTON, DICKINSON AND COMPANY
`1 BECTON DRIVE, MCll0
`FRANKLIN LAKES, NJ 07417-1880 (US)
`
`(73)
`
`Assignee: Becton, Dickinson and Company, Fran-
`klin Lakes, NJ
`
`(21)
`
`Appl. No.:
`
`11/281,711
`
`(22)
`
`Filed:
`
`Nov. 17, 2005
`
`(51) Int. CI.
`A61M 39/10
`(2006.01)
`A61M 39/00
`(2006.01)
`A61M 25/16
`(2006.01)
`A61M 25/18
`(2006.01)
`(52) U.S. CI ............................................................... 604/533
`
`(57)
`
`ABSTRACT
`
`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 dxy 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 antinficrobial
`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.
`
`14
`
`A10
`
`A2
`
`A
`
`18
`
`B
`
`16
`
`10
`
`(
`A6
`
`CCI 2004
`
`1
`
`

`

`Patent Application Publication May 17, 2007 Sheet 1 of 7
`
`US 2007/0112333 A1
`
`2
`
`

`

`Patent Application Publication May 17, 2007 Sheet 2 of 7
`
`US 2007/0112333 A1
`
`FIG. 2
`
`lO
`
`j
`
`14
`
`24 14~
`
`FIG. 3
`
`16
`
`12
`/
`
`..10
`
`14
`
`""~2
`
`16b ..._./
`
`22 12a14a 14bl ,,
`
`3
`
`

`

`Patent Application Publication May 17, 2007 Sheet 3 of 7
`
`US 2007/0112333 A1
`
`FIG. 4
`
`16a
`
`4
`
`

`

`Patent Application Publication May 17, 2007 Sheet 4 of 7
`
`US 2007/0112333 A1
`
`FIG. 5
`
`34
`
`36
`
`Clean
`
`S I olean with
`
`ic ces i I~’~l al~ee~ i~;tive~"
`
`54
`
`Cap with
`Cap / Cleaner
`lOa
`
`4O
`
`I Cap with
`
`Cap / Cleaner
`lOa
`
`42
`
`Clean with
`Cap ! Cleaner
`10
`
`Cap / Cleaner
`lOa
`
`Cap with
`Cap / Cleaner
`lOa
`
`Ca~ with
`Cap / Cleaner
`lOa
`
`Cap with
`Cap / Cleaner
`lob
`
`44
`
`48
`
`50
`
`5
`
`

`

`Patent Application Publication May 17, 2007 Sheet 5 of 7
`
`US 2007/0112333 A1
`
`FIG. 6
`
`FIG. 7
`
`58
`
`62
`
`6O
`
`62
`
`6O
`
`6
`
`

`

`Patent Application Publication May 17, 2007 Sheet 6 of 7
`
`US 2007/0112333 A1
`
`FIG. 8
`
`68
`
`6O
`
`FIG. 9
`
`60
`
`58
`
`62
`
`7
`
`

`

`Patent Application Publication May 17, 2007 Sheet 7 of 7
`
`US 2007/0112333 A1
`
`FIG. 10A
`
`k\\\\\\\\\\\\\\
`
`\~,,~
`
`74a
`
`78a
`
`FIG. 10B
`
`80
`
`8
`
`

`

`US 2007/0112333 A1
`
`May 17, 2007
`
`PATIENT FLUID LINE ACCESS VALVE
`ANTIMICROBIAL CAP/CLEANER
`
`[0012] FIG. 7 is a cross-sectional side view of the second
`cap/cleaner device.
`
`BACKGROUND OF THE INVENTION
`
`[0001] 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.
`
`[0002] 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 addxess issues such as
`hand hygiene, catheter site care and admixture preparation.
`Despite these guidelines, catheter-related bloodstream infec-
`tions continue to plague our healthcare system.
`
`[0003] 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
`developed resistance to the various antimicrobial agents in
`the system.
`
`[0004] 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 number of catheter-related infections.
`
`BRIEF SUMMARY OF THE INVENTION
`
`[0005] The present invention is a device for antiseptically
`maintaining 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
`
`[0006] FIG. 1 is an exploded view of a first representative
`embodiment of a cap/cleaner device and a patient fluid line
`access valve.
`
`[0007] FIG. 2 is a cross-sectional side view of the first
`representative embodiment of the cap/cleaner device.
`
`[0008] FIG. 3 is a cross-sectional side view of the first
`cap/cleaner device capping a patient fluid line access valve.
`
`[0009] FIG. 4 is a cross-sectional side view of the first
`cap/cleaner device cleaning a patient fluid line access valve.
`
`[0010] FIG. 5 is a flow chart illustrating representative
`embodiments of methods of using the cap/cleaner device.
`
`[0011] FIG. 6 is a perspective view of a second represen-
`tative embodiment of a cap/cleaner device.
`
`[0013] FIG. 8 is a cross-sectional view of a first separable
`connector.
`
`[0014] FIG. 9 is a side view of a second separable con-
`nector.
`
`[0015] FIG. 10A is a cross-sectional view of cleaning
`device.
`
`[0016] FIG. 10B is a cross-sectional view of a capping
`device.
`
`DETAILED DESCRIPTION
`
`[0017] 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 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 A10 of access valve A. Line B may be
`any of a number of types that include, for example, intra-
`vascular (IV) lines and catheters, saline wells, arterial lines
`and hemodialysis lines.
`
`[0018] As will be described in more detail below, cap end
`14 of cap/cleaner 10 attaches to access portionA10 of access
`valve A. Housing 12 is made from any of a number of types
`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.
`
`[0019] Cap end 14 of housing 12 is open and contains
`thread 18 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 clemfing end 16. Any type of material or seal may
`be used as long as a moisture barrier is provided.
`
`[0020] 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. Internal wall 12a separates cap end 14 and cleaning end
`16.
`
`[0021] 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-SyteTM valve from Becton, Dickinson and Company
`(illustrated in FIG. 1). However, cap/cleaner 10 is useful
`with any type of needleless or needle-reqnired access valve.
`Once removed from the package, cap/cleaner 10 is ready for
`use.
`
`[0022] FIG. 3 illustrates cap/cleaner 10 covering access
`portion A10 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 A8 extends through septum A6 to provide a port
`for insertion of the male luer taper.
`
`9
`
`

`

`US 2007/0112333 A1 May 17, 2007
`2
`
`[0023] 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 A10 of valve A. Suitable
`material for dxy 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 antimicrobial agents may be used to impregnate
`dry pad 24. Some examples include chlorhexidine glucon-
`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 A10.
`
`[0024] In use, cap end 14 of cap/cleaner 10 is placed over
`access portion A10 such that access portion A10 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 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
`luer slip, which does not have a thread. In other embodi-
`ments, cap/cleaner 10 may be manufactured without a
`thread.
`
`[0025] The amount of material used for dry pad 24 can
`vary. Typically, there is enough material for dxy 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 A10 of
`valve A to be encompassed by cap end 14, thus, maintaining
`antiseptic conditions of the surface. By maintaining antisep-
`tic conditions of the surface, the risk of microbes penetrating
`into valve A is minimized.
`
`[0026] To further minimize the opportunity for penetration
`by microbes, access portion A10 is cleaned prior to access-
`ing valve A with a needle or male luer taper. FIG. 4
`illustrates cap/cleaner 10 cleaning access portion A10 of
`valve A.
`
`[0027] 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
`antimicrobial agent. Wet pad 22 may be made from materials
`similar to those described for dry pad 24.
`
`[0028] The cleaning solution is typically an alcohol- or
`water-based solution. A suitable alcohol-based solution con-
`tains 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 fragrance, dye, surfactant, emollient, etc.
`
`[0029] 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.
`
`[0030] In an alternative embodiment, the cleaning solution
`also includes an antimicrobial agent. Any of a number of
`antimicrobial agents may be used in wet pad 22. Some
`examples include chlorhexidine gluconate, chlorhexidine
`diacetate, chloroxylenol, povidone iodine, Triclosan, benze-
`thonium chloride, benzalkonium chloride, octenidine, anti-
`
`biotic, etc. Wet pad 22 and dry pad 24 may be impregnated
`with the same or different antimicrobial agents.
`
`[0031] 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 A10 of valve A, and
`chamber 16b is sized to allow some movement when access
`portion A10 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.
`
`[0032] 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 A10, 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.
`
`[0033] Next, for thorough cleaning, wet pad 22 should
`scrub access portion A10 of valve A. Scrubbing may be
`accomplished 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 A10 of valve A.
`
`[0034] Once cleaned, valve A is ready to use. A needle or
`male luer taper is inserted to either infuse or withdxaw fluid
`from the patient fluid line.
`
`[0035] FIG. 5 is a flowchart illustrating representative
`embodiments 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 withdxawal after accessing the patient fluid
`line, access portion A10 of valve A may either be immedi-
`ately capped or cleaned again prior to capping. If immedi-
`ately 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 portion
`A10 as described above. Cleaning end 16 of cap/cleaner 10a
`is sealed and ready for the next time valve A is utilized.
`
`[0036] Alternatively, access portion A10 may be cleaned
`again prior to capping. This can be performed in one of the
`following ways. First, in step 42, cleaning end 16 of cap/
`cleaner 10 is reused to clean access portion A10, which is
`then capped, at step 44, with cap end 14 of a new, second
`cap/cleaner 10a. Second, in step 46, cleaning end 16 of a
`new, second cap/cleaner 10a is used to clean access portion
`A10. Then, valve A may be capped either with cap end 14
`of cap/cleaner 10a (step 48) or of a new, third cap/cleaner
`10b (step 50). Third, in step 52, access portion A10 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 10a may be attached to
`valve 26 (step 50).
`
`[0037] Additional embodiments of the present invention
`include separable and individual, uncoupled devices. FIG. 6
`shows separable cap/cleaner 56. Separable cap/cleaner 56
`
`10
`
`

`

`US 2007/0112333 A1 May 17, 2007
`3
`
`includes cap end 58, cleaning end 60 and gap 62. Gap 62 is
`the separation between cap end 58 and cleaning end 60.
`
`1. A device for antiseptically maintaining a patient fluid
`line access valve, the device comprising:
`
`[0038] FIG. 7 shows separable cap/cleaner 56 in more
`detail and further includes dxy pad 64 within cap end 58, wet
`pad 66 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 A10 of valve A.
`Detaching cleaning end 60 reduces bulkiness from separable
`cap/cleaner 56 by only maintaining cap end 58 over access
`portion A10.
`
`[0039] 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 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 contralateral to the direction of the terminal (cap end
`58 and cleaning end 60) force vectors, may be applied for
`breaking connector 68. Once removed, cleaning end 60 may
`be discarded.
`
`[0040] 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.
`
`[0041] 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.
`
`[0042] FIG. 10A 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.
`
`[0043] 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.
`
`[0044] Where pad 80 is a wet pad, cap device 78 may be
`used to clean access portion A10 of valve A in addition to its
`capping function. The twisting motion involved in removing
`and placing cap device 78 with respect to access potion A10
`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.
`
`[0045] With either cleaning device 74 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.
`
`[0046] 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 microbes into the access valves, particularly for needle-
`less access valves.
`
`[0047] 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.
`
`a housing for covering an access portion of the access
`valve; and
`
`a pad within the housing for contacting an access portion
`of the access valve to reduce the amount of microbes on
`the access portion.
`2. The device of claim 1 wherein the housing further
`comprises:
`
`a cap with a cavity for covering the access portion;
`
`wherein the pad is within the cavity of the cap.
`3. The device of claim 2 wherein the pad is impregnated
`with an antimicrobial agent.
`4. The device of claim 2 wherein the cap includes a thread
`within the cavity.
`5. The device of claim 2 wherein the pad is one of a dry
`pad and a wet pad.
`6. The device of claim 5 wherein the wet pad contains a
`cleaning solution.
`7. The device of claim 1 wherein the housing further
`comprises:
`
`a hood with a chamber for covering the access portion;
`
`wherein the pad is a wet pad within the chamber.
`8. The device of claim 7 wherein the wet pad contains a
`cleaning solution.
`9. The device of claim 8 wherein the wet pad contains an
`antimicrobial agent.
`10. The device of claim 1 and further comprising:
`
`a lid sealing the pad within the housing.
`11. A device for reducing risk of contamination of a
`patient fluid line access valve, the device comprising:
`
`means for cleaning an access portion of the access valve
`with a cleaning solution;
`
`means for covering the access portion of the access valve;
`and
`
`means for coupling the means for cleaning and the means
`for covering.
`12. The device of claim 11 wherein the means for cou-
`pling comprises a housing.
`13. The device of claim 11 wherein the means for cou-
`pling comprises a separable connector.
`14. The device of claim 11 and filrther comprising:
`
`means for retaining an antimicrobial agent within the
`means for covering.
`15. The device of claim 11 and further comprising:
`
`means for securing the means for covering to the access
`valve.
`16. The device of claim 11 and further comprising:
`
`means for sealing the means for cleaning.
`17. A method of reducing risk of contamination of a
`patient fluid line access valve, the method comprising:
`
`attaching a first cap of a first device to an access portion
`of the access valve;
`
`cleaning the access portion of the access valve with a first
`wet pad of the first device prior to accessing the patient
`fluid line; and
`
`11
`
`

`

`US 2007/0112333 A1 May 17, 2007
`4
`
`attaching a second cap of a second device to the access
`portion of the access valve after accessing the patient
`fluid line.
`18. The method of claim 17 and further comprising:
`
`cleaning the access portion of the access valve with the
`first wet pad of the first device after accessing the
`patient fluid line.
`
`19. The method of claim 17 and further comprising:
`
`cleaning the access portion of the access valve with a
`second wet pad of the second device after accessing the
`patient fluid line.
`
`20. The method of claim 17 and further comprising:
`
`cleaning the access portion of the access valve with one
`of an alcohol wipe and iodine swab after accessing the
`patient fluid line.
`21. The method of claim 17 wherein the first cap of the
`first device is attached to the access portion of the access
`valve after placement of a catheter and the access valve for
`a patient.
`22. The method of claim 17 wherein the first cap of the
`first device is attached to the access portion of the access
`valve prior to placement of a catheter and the access valve
`for a patient.
`
`12
`
`