UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`
`Our Docket No.: B819.12-0004
`
`I Date: November 17, 2005
`
`First Named Inventor: Minh Quang Hoang
`
`Title:
`
`PATIENT FLUID LINE ACCESS VALVE ANTIMICROBIAL
`CAP/CLEANER
`
`0
`
`Express Mail No.: EV655619585US
`
`APPLICATION ELEMENTS
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1. [X] Fee Calculation Sheet
`(Submit an original and a duplicate for fee processing)
`
`2. [ J Applicant claims small entity status
`
`Total Pages [12)
`3. [ X] Specification
`- Descriptive title of the invention
`- Cross References to Related Applications
`- Statement Regarding Fed. Sponsored R&D
`- Reference to Microfiche Appendix
`- Background of the Invention
`- Brief Summary of the Invention
`- Brief Description of the Drawings (if filed)
`- Detailed Description
`- Claims
`- Abstract of the Disclosure
`4. [X] Drawings (35 U.S.C. 113)
`5. [X] Oath or Declaration
`a. [X] Newly Executed (original or copy)
`b. [ J Copy from a prior application (37 C.F.R. 1.63(d) - for
`continuation/divisional with Box 18 completed)
`[Mark Box 5 below]
`I. [ ) DELETION OF INVENTOR(Sl
`Signed statement attached deleting inventor(s) named
`in the prior application, see 37 C.F.R. 1.63(d)(2) and
`1.33(b)
`[X) Application Data Sheet. See 37 CFR 1.76.
`
`Total Sheets (7)
`Total Pages [2]
`
`6.
`
`7.
`
`8.
`
`[ ] CD-ROM or CD-R in duplicate, large
`table or Computer Program (Appendix)
`Nucleotide and/or Amino Acid Sequence Submission
`(If applicable, all necessary)
`a. [ ] Computer Readable Copy (CRF)
`b. Specification Sequence Listing on:
`i. [ J CD-ROM or CD-R (2 copies; or
`ii. [ ] Paper
`c. [ ] ~tatements verifying identify of above copies
`
`ACCOMPANYING APPLICATION PARTS
`
`9.
`10.
`
`11.
`12.
`
`13.
`14.
`
`15.
`
`16.
`
`17.
`
`[X] Assignment Papers (cover sheet & document(s))
`( ] 37 C.F.R. 3.73(b) Submission
`[ ] Power of Attorney
`[ ] English Translation Document (if applicable)
`[ ]
`Information Disclosure Statement with copies of Citations
`as necessary
`Total Pages [ ]
`[ ] Preliminary Amendment
`[X] Return Receipt Postcard (Should be specifically
`itemized)
`( ) Certified Copy of Priority document(s) (If foreign priority is
`claimed)
`[ J Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`Application must attach form PTO/SB/35 or its equivalent
`[ ] Other
`
`18. If a CONTINUING APPLICATION, check appropriate box and supply the requisite information below and in a preliminary amendment, or in an
`Application Data Sheet under 37 CFR 1. 76:
`( ] Continuation
`[ ) Division [ ] Continuation-in-part (CIP) of prior Application No.
`
`Prior Application Information: Examiner_ Group Art Unit_
`For CONTINUATION OR DIVISIONAL APPS only: The entire disclosure of the prior application, from which an oath or declaration is supplied under
`Box 5b is considered a part of the disclosure of the accompanying continuation or divisional application and is hereby incorporated by reference. The
`incorporation can only be relied upon when a portion has been inadvertently omitted from the submitted application parts.
`
`19. CORRESPONDENCE ADDRESS
`
`ATTY NAME
`AND REG. NO.
`
`ADDRESS
`
`David R. Fairbairn
`Reg. No. 26,047
`
`Kinney & Lange, P.A.
`THE KINNEY & LANGE BUILDING
`312 South Third Street
`Minneapolis, MN 55415-1002
`
`SIGNATURE: VQ ~~ --
`
`TELEPHONE
`
`(612) 339-1863
`
`FAX: (612) 339-6580
`
`BAXTER EXHIBIT 1021
`Page 1 of 385
`
`

`

`FEE TRANSMITTAL
`
`Total Amount of Pavment $ 1 140.00
`
`METHOD OF PAYMENT (Check One)
`1. 00 The Commissioner is hereby authorized to charge any additional fee
`required under 37 C.F.R. 1.16 and 1.17 and credit any over payments to
`Deposit Account No.11-0982. Deposit Account Name: Kinney & Lange,
`P.A. A duplicate copy of this communication is enclosed.
`
`2. [X] Check Enclosed
`
`1. BASIC FILING FEE
`
`FEE CALCULATION
`
`FILING FEE SEARCH FEES EXAM FEES
`Appn. Type FEE/SMALL FEE/SMALL
`FEE/SMALL
`FEES
`!:Q.c
`
`Application No.
`
`Filing Date
`
`Complete if Known
`
`November 17, 2005
`
`First Named Inventor
`
`Minh Quang Hoang
`
`Group Art Unit
`
`Examiner Name
`
`Atty. Docket Number
`
`8819.12-0004
`
`FEE CALCULATION (Continued)
`3. ADDITIONAL FEES
`
`Large Entity Small Entity
`Fee
`Fee Fee
`Fee
`Code
`Code
`($)
`($)
`
`Fee Description
`
`Fee paid
`
`1051
`
`130 2051
`
`65
`
`Surcharge - Late filing fee or oath
`
`1052
`
`50 2052
`
`25
`
`1053
`
`130 1053
`
`130
`
`Surcharge - late provisional filing fee
`or cover sheet
`Non-English specification
`
`1812
`
`2,520 1812 2,520
`
`For Filing a Request for Reexamination
`
`1251
`
`120 2251
`
`60
`
`Extension for reply within first month
`
`Utility
`
`300 / 150
`
`500 / 250
`
`200 / 100
`
`1252
`
`450 2252
`
`225
`
`Extension for reply within second month
`
`Design
`
`200 / 100
`
`100 / 50
`
`130 / 65
`
`Reissue
`
`300 / 150
`
`500 / 250
`
`600 / 300
`
`Provisional 200 / 100
`
`-0- I -0-
`
`-0-
`
`I -0-
`
`1253
`
`1,020 2253
`
`510
`
`Extension for reply within third month
`
`1254
`
`1,590 2254
`
`795
`
`Extension for reply within fourth month
`
`1255
`
`2,160 2255
`
`1,080
`
`Extension for reply within fifth month
`
`500 2402
`
`250
`
`Filing a brief in support of an appeal
`
`Subtotal (1) $1,000.00
`
`2. EXTRA CLAIM FEES
`Number
`Prior
`Claims
`20 = _£ X
`22
`-
`Total
`lndep. _i _i = _Q_ X
`
`Extra
`
`Multiple Dependent Claims
`
`Fee from Fee Paid
`Below
`_§.Q = 100
`200 = _0_
`_o =_o_
`
`Insert 3 and 20, or number previously paid if greater; Reissue see
`below
`Large Entity
`Fee
`Fee
`~ ..ill
`
`Small Entity
`Fee
`Fee
`ill
`Code
`
`Description
`
`1202
`1201
`
`1203
`1204
`
`1205
`
`50
`200
`
`360
`200
`
`50
`
`2202
`2201
`
`2203
`2204
`
`2205
`
`25
`100
`
`180
`100
`
`25
`
`Claims in excess of 20
`Independent claims in excess
`of 3
`Multiple Dependent Claim
`Reissue Independent Claims
`Over Original Patent
`Reissue claims in excess of 20
`and over original patent
`
`3. APPLICATION SIZE FEE
`If the specification and drawings exceed 100 sheets of paper, the
`application size fee due is $250 ($125 small) for each additional 50
`sheets or fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 C.F.R.
`s-o-
`1.16(s).
`
`Subtotal (2) $100.00
`
`1402
`
`1403
`
`1,000 2403
`
`500
`
`Request for oral hearing
`
`1814
`
`130 2814
`
`65
`
`Terminal Disclaimer Fee
`
`1452
`
`500 2452
`
`250
`
`Petition to revive • unavoidable
`
`1453
`
`1,500 2453
`
`750
`
`Petition to revive : unintentional
`
`1501
`
`1,400 2501
`
`700
`
`Utility/Reissue issue fee
`
`1502
`
`800 2502
`
`400
`
`Design issue fee
`
`1460
`
`130 1460
`
`130
`
`Petitions to the Commissioner
`
`1807
`
`50 1807
`
`50
`
`Petitions related to provisional applications
`
`1806
`
`180 1806
`
`180
`
`Submission of Information Disclosure
`Statement
`
`8021
`
`40 8021
`
`40
`
`Recording each patent assignment per
`property (limes number of properties)
`
`1801
`
`790 2801
`
`395
`
`Request for Continued Examination
`(RCE)
`
`Other fee (specify) ____________ _
`
`Subtotal (3) $40.00
`
`___ = _____ -_ Reg. No. ----=26""'""'0""'"4"'""7 _______ _
`_____ [5L
`
`Deposit Account No. ___ 1_1--0_9~8-2 ____ _
`
`Signature_~W&-~_·
`8
`.... ;,...!J-_________ _
`
`Date ___ D_,a,-+~....,2-i'/_· ~rl'-a~/4 ....
`
`
`
`1/
`
`BAXTER EXHIBIT 1021
`Page 2 of 385
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`First Named
`Inventor
`
`Appln. No.
`
`Filed
`
`Title
`
`Minh Quang Hoang
`
`November 17, 2005
`
`PATIENT FLUID LINE ACCESS VAL VE
`ANTIMICROBIAL CAP/CLEANER
`
`Docket No.
`
`B819.12-0004
`
`Group Art Unit:
`
`Examiner:
`
`EXPRESS MAIL COVER SHEET
`
`Commissioner For Patents
`P.O. Box 1450
`Alexandria, VA 22313-14 5 0
`
`SENT VIA EXPRESS MAIL
`
`Express Mail No.: I I rEV b5 561958 SU sJ
`
`The following papers are being transmitted via EXPRESS MAIL to the U.S. Patent and
`
`Trademark Office on the date shown below:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Fee Calculation Form with attached checks for $1,100.00 and $40.00;
`
`Utility Patent Application Transmittal;
`
`Utility Patent Application (12 pages);
`
`Drawings (7 sheets);
`
`Declaration;
`
`Patent Recordation Cover Sheet;
`
`Assignment; and
`
`File Data Form.
`
`Date:
`
`If /i~'r
`I
`
`DRF:CJB:kmm
`
`Respectfully submitted,
`KINNEY & LANGE, P.A.
`
`By~~
`David R. Fairbairn, Reg. No. 26,047
`THE KINNEY & LANGE BUILDING
`312 South Third Street
`Minneapolis, MN 55415-1002
`Telephone: (612) 339-1863
`Fax: (612) 339-6580
`
`BAXTER EXHIBIT 1021
`Page 3 of 385
`
`

`

`UTILITY
`PATENT APPLICATION
`TRANSMITTAL
`
`Our Docket No.: B819.12-0004
`
`I Date: November 17, 2005
`
`First Named Inventor: Minh Quang Hoang
`
`Title:
`
`PATIENT FLUID LINE ACCESS VALVE ANTIMICROBIAL
`CAP/CLEANER
`
`0
`
`Express Mail No.: EV655619585US
`
`APPLICATION ELEMENTS
`
`ADDRESS TO:
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`1. [X] Fee Calculation Sheet
`(Submit an original and a duplicate for fee processing)
`
`2. [ J Applicant claims small entity status
`
`Total Pages [12)
`3. [ X] Specification
`- Descriptive title of the invention
`- Cross References to Related Applications
`- Statement Regarding Fed. Sponsored R&D
`- Reference to Microfiche Appendix
`- Background of the Invention
`- Brief Summary of the Invention
`- Brief Description of the Drawings (if filed)
`- Detailed Description
`- Claims
`- Abstract of the Disclosure
`4. [X] Drawings (35 U.S.C. 113)
`5. [X] Oath or Declaration
`a. [X] Newly Executed (original or copy)
`b. [ J Copy from a prior application (37 C.F.R. 1.63(d) - for
`continuation/divisional with Box 18 completed)
`[Mark Box 5 below]
`I. [ ) DELETION OF INVENTOR(Sl
`Signed statement attached deleting inventor(s) named
`in the prior application, see 37 C.F.R. 1.63(d)(2) and
`1.33(b)
`[X) Application Data Sheet. See 37 CFR 1.76.
`
`Total Sheets (7)
`Total Pages [2]
`
`6.
`
`7.
`
`8.
`
`[ ] CD-ROM or CD-R in duplicate, large
`table or Computer Program (Appendix)
`Nucleotide and/or Amino Acid Sequence Submission
`(If applicable, all necessary)
`a. [ ] Computer Readable Copy (CRF)
`b. Specification Sequence Listing on:
`i. [ J CD-ROM or CD-R (2 copies; or
`ii. [ ] Paper
`c. [ ] ~tatements verifying identify of above copies
`
`ACCOMPANYING APPLICATION PARTS
`
`9.
`10.
`
`11.
`12.
`
`13.
`14.
`
`15.
`
`16.
`
`17.
`
`[X] Assignment Papers (cover sheet & document(s))
`( ] 37 C.F.R. 3.73(b) Submission
`[ ] Power of Attorney
`[ ] English Translation Document (if applicable)
`[ ]
`Information Disclosure Statement with copies of Citations
`as necessary
`Total Pages [ ]
`[ ] Preliminary Amendment
`[X] Return Receipt Postcard (Should be specifically
`itemized)
`( ) Certified Copy of Priority document(s) (If foreign priority is
`claimed)
`[ J Nonpublication Request under 35 U.S.C. 122(b)(2)(B)(i).
`Application must attach form PTO/SB/35 or its equivalent
`[ ] Other
`
`18. If a CONTINUING APPLICATION, check appropriate box and supply the requisite information below and in a preliminary amendment, or in an
`Application Data Sheet under 37 CFR 1. 76:
`( ] Continuation
`[ ) Division [ ] Continuation-in-part (CIP) of prior Application No.
`
`Prior Application Information: Examiner_ Group Art Unit_
`For CONTINUATION OR DIVISIONAL APPS only: The entire disclosure of the prior application, from which an oath or declaration is supplied under
`Box 5b is considered a part of the disclosure of the accompanying continuation or divisional application and is hereby incorporated by reference. The
`incorporation can only be relied upon when a portion has been inadvertently omitted from the submitted application parts.
`
`19. CORRESPONDENCE ADDRESS
`
`ATTY NAME
`AND REG. NO.
`
`ADDRESS
`
`David R. Fairbairn
`Reg. No. 26,047
`
`Kinney & Lange, P.A.
`THE KINNEY & LANGE BUILDING
`312 South Third Street
`Minneapolis, MN 55415-1002
`
`SIGNATURE: VQ ~~ --
`
`TELEPHONE
`
`(612) 339-1863
`
`FAX: (612) 339-6580
`
`BAXTER EXHIBIT 1021
`Page 4 of 385
`
`

`

`FEE TRANSMITTAL
`
`Total Amount of Pavment $ 1 140.00
`
`METHOD OF PAYMENT (Check One)
`1. 00 The Commissioner is hereby authorized to charge any additional fee
`required under 37 C.F.R. 1.16 and 1.17 and credit any over payments to
`Deposit Account No.11-0982. Deposit Account Name: Kinney & Lange,
`P.A. A duplicate copy of this communication is enclosed.
`
`2. [X] Check Enclosed
`
`1. BASIC FILING FEE
`
`FEE CALCULATION
`
`FILING FEE SEARCH FEES EXAM FEES
`Appn. Type FEE/SMALL FEE/SMALL
`FEE/SMALL
`FEES
`!:Q.c
`
`Application No.
`
`Filing Date
`
`Complete if Known
`
`November 17, 2005
`
`First Named Inventor
`
`Minh Quang Hoang
`
`Group Art Unit
`
`Examiner Name
`
`Atty. Docket Number
`
`8819.12-0004
`
`FEE CALCULATION (Continued)
`3. ADDITIONAL FEES
`
`Large Entity Small Entity
`Fee
`Fee Fee
`Fee
`Code
`Code
`($)
`($)
`
`Fee Description
`
`Fee paid
`
`1051
`
`130 2051
`
`65
`
`Surcharge - Late filing fee or oath
`
`1052
`
`50 2052
`
`25
`
`1053
`
`130 1053
`
`130
`
`Surcharge - late provisional filing fee
`or cover sheet
`Non-English specification
`
`1812
`
`2,520 1812 2,520
`
`For Filing a Request for Reexamination
`
`1251
`
`120 2251
`
`60
`
`Extension for reply within first month
`
`Utility
`
`300 / 150
`
`500 / 250
`
`200 / 100
`
`1252
`
`450 2252
`
`225
`
`Extension for reply within second month
`
`Design
`
`200 / 100
`
`100 / 50
`
`130 / 65
`
`Reissue
`
`300 / 150
`
`500 / 250
`
`600 / 300
`
`Provisional 200 / 100
`
`-0- I -0-
`
`-0-
`
`I -0-
`
`1253
`
`1,020 2253
`
`510
`
`Extension for reply within third month
`
`1254
`
`1,590 2254
`
`795
`
`Extension for reply within fourth month
`
`1255
`
`2,160 2255
`
`1,080
`
`Extension for reply within fifth month
`
`500 2402
`
`250
`
`Filing a brief in support of an appeal
`
`Subtotal (1) $1,000.00
`
`2. EXTRA CLAIM FEES
`Number
`Prior
`Claims
`20 = _£ X
`22
`-
`Total
`lndep. _i _i = _Q_ X
`
`Extra
`
`Multiple Dependent Claims
`
`Fee from Fee Paid
`Below
`_§.Q = 100
`200 = _0_
`_o =_o_
`
`Insert 3 and 20, or number previously paid if greater; Reissue see
`below
`Large Entity
`Fee
`Fee
`~ ..ill
`
`Small Entity
`Fee
`Fee
`ill
`Code
`
`Description
`
`1202
`1201
`
`1203
`1204
`
`1205
`
`50
`200
`
`360
`200
`
`50
`
`2202
`2201
`
`2203
`2204
`
`2205
`
`25
`100
`
`180
`100
`
`25
`
`Claims in excess of 20
`Independent claims in excess
`of 3
`Multiple Dependent Claim
`Reissue Independent Claims
`Over Original Patent
`Reissue claims in excess of 20
`and over original patent
`
`3. APPLICATION SIZE FEE
`If the specification and drawings exceed 100 sheets of paper, the
`application size fee due is $250 ($125 small) for each additional 50
`sheets or fraction thereof. See 35 U.S.C. 41(a)(1)(G) and 37 C.F.R.
`s-o-
`1.16(s).
`
`Subtotal (2) $100.00
`
`1402
`
`1403
`
`1,000 2403
`
`500
`
`Request for oral hearing
`
`1814
`
`130 2814
`
`65
`
`Terminal Disclaimer Fee
`
`1452
`
`500 2452
`
`250
`
`Petition to revive • unavoidable
`
`1453
`
`1,500 2453
`
`750
`
`Petition to revive : unintentional
`
`1501
`
`1,400 2501
`
`700
`
`Utility/Reissue issue fee
`
`1502
`
`800 2502
`
`400
`
`Design issue fee
`
`1460
`
`130 1460
`
`130
`
`Petitions to the Commissioner
`
`1807
`
`50 1807
`
`50
`
`Petitions related to provisional applications
`
`1806
`
`180 1806
`
`180
`
`Submission of Information Disclosure
`Statement
`
`8021
`
`40 8021
`
`40
`
`Recording each patent assignment per
`property (limes number of properties)
`
`1801
`
`790 2801
`
`395
`
`Request for Continued Examination
`(RCE)
`
`Other fee (specify) ____________ _
`
`Subtotal (3) $40.00
`
`___ = _____ -_ Reg. No. ----=26""'""'0""'"4"'""7 _______ _
`_____ [5L
`
`Deposit Account No. ___ 1_1--0_9~8-2 ____ _
`
`Signature_~W&-~_·
`8
`.... ;,...!J-_________ _
`
`Date ___ D_,a,-+~....,2-i'/_· ~rl'-a~/4 ....
`
`
`
`1/
`
`BAXTER EXHIBIT 1021
`Page 5 of 385
`
`

`

`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`First Named
`Inventor
`
`Appln. No.
`
`Filed
`
`Title
`
`Minh Quang Hoang
`
`November 17, 2005
`
`PATIENT FLUID LINE ACCESS VAL VE
`ANTIMICROBIAL CAP/CLEANER
`
`Docket No.
`
`B819.12-0004
`
`Group Art Unit:
`
`Examiner:
`
`EXPRESS MAIL COVER SHEET
`
`Commissioner For Patents
`P.O. Box 1450
`Alexandria, VA 22313-14 5 0
`
`SENT VIA EXPRESS MAIL
`
`Express Mail No.: I I rEV b5 561958 SU sJ
`
`The following papers are being transmitted via EXPRESS MAIL to the U.S. Patent and
`
`Trademark Office on the date shown below:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`8.
`
`Fee Calculation Form with attached checks for $1,100.00 and $40.00;
`
`Utility Patent Application Transmittal;
`
`Utility Patent Application (12 pages);
`
`Drawings (7 sheets);
`
`Declaration;
`
`Patent Recordation Cover Sheet;
`
`Assignment; and
`
`File Data Form.
`
`Date:
`
`If /i~'r
`I
`
`DRF:CJB:kmm
`
`Respectfully submitted,
`KINNEY & LANGE, P.A.
`
`By~~
`David R. Fairbairn, Reg. No. 26,047
`THE KINNEY & LANGE BUILDING
`312 South Third Street
`Minneapolis, MN 55415-1002
`Telephone: (612) 339-1863
`Fax: (612) 339-6580
`
`BAXTER EXHIBIT 1021
`Page 6 of 385
`
`

`

`PATIENT FLUID LINE ACCESS VAL VE ANTIMICROBIAL CAP/CLEANER
`
`P-6836
`
`BACKGROUND OF THE INVENTION
`
`5
`
`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
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`10
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`20,000 deaths per year.
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`Guidelines from the Centers for Disease Control and Prevention
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`describe various ways to limit catheter-related bloodstream infections in hospital,
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`outpatient and home care settings. The guidelines address issues such as ;hand
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`hygiene, catheter site care and admixture preparation. Despite these guidelines,
`
`1s
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`catheter-related bloodstream infections continue to plague our healthcare system.
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`Impregnating catheters with various antimicrobial agents is one
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`. approach that has been implemented to prevent these infections. These catheters,
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`however, have given less than satisfactory results. In addition, some microbes have
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`developed resistance to the various antimicrobial agents in the system.
`
`20
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`In another system that is commercially available in Europe, a
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`catheter hub containing an antiseptic chamber is filled with three percent iodinated
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`alcohol. Though it has shown to be effective, the catheter hub is expensive and
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`does not fare as well in a formal cost-benefit analysis. Therefore, there is a need for
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`an effective and inexpensive way to reduce the number of catheter-related
`
`2 s
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`infections.
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`BRIEF SUMMARY OF THE INVENTION
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`The present invention is a device for antiseptically maintaining a
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`patient fluid line access valve. The device includes a housing for covering the
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`access portion of the access valve. A pad within the housing contacts the surface of
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`30
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`the access portion of the access valve prior to (and optionally after) accessing the
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`2
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`patient fluid line via the access valve to reduce the amount of microbes on the
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`valve's access portion.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`Figure 1 is an exploded view of a first representative embodiment of
`
`5
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`a cap/cleaner device and a patient fluid line access valve.
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`Figure 2 is a cross-sectional side view of the first representative
`
`embodiment of the cap/cleaner device.
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`Figure 3 is a cross-sectional side view of the first cap/cleaner device
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`capping a patient fluid line access valve.
`
`10.
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`Figure 4 is a cross-sectional side view of the first cap/cleaner device
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`cleaning a patient fluid line access valve.
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`Figure 5 is a flow chart illustrating representative embodiments of
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`methods of using the cap/cleaner device.
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`Figure 6 is a perspective view of a second representative
`
`15
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`embodiment of a cap/cleaner device.
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`Figure 7 is a cross-sectional side view of the second cap/cleaner
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`device.
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`Figure 8 is a cross-sectional view of a first separable connector.
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`Figure 9 is a side view of a second separable connector.
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`20
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`Figure 1 0A is a cross-sectional view of cleaning device.
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`Figure I OB is a cross-sectional view of a capping device.
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`DETAILED DESCRIPTION
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`Figure 1 shows an exploded view of patient fluid line access valve
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`cap/cleaner device 10 with patient fluid line access valve A and patient fluid line B.
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`25
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`Cap/cleaner 10 includes housing 12 with cap end 14, cleaning end 16 and thread
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`18; and lid 20. Access valve A includes housing A2 with thread A4 and septum A6
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`with slit A8. The exposed surface of septum A6 along with at least a portion of the
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`exposed surface of housing A2 that surrounds septum A6, form access portion A 10
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`3
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`of access valve A Line B may be any of a number of types that include, for
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`example, intravascular (IV) lines and catheters, saline wells, arterial lines and
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`hemodialysis lines.
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`As will be described in more detail below, cap end 14 of cap/cleaner 10
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`5
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`attaches to access portion Al0 of access valve A Housing 12 is made from any of
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`a number of types of plastic materials such as polycarbonate, polypropylene,
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`polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene
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`styrene or any other moldable plastic material used in medical devices.
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`Cap end 14 of housing 12 is open and contains thread 18 along the inside of
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`10
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`the opening. Cleaning end 16 is covered by lid 20. Lid 20 is typically made of foil
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`or similar type material and completely seals the opening (not shown) of cleaning
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`end 16. Any type of material or seal may be used as long as a moisture barrier is
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`provided.
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`Figure 2 shows cap/cleaner 10 in more detail. In addition to the structures
`
`15
`
`shown in Figure 1, cap/cleaner 10 also includes internal wall 12a, hood 16a and
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`chamber 16b of cleaning end 16, cap 14a and cavity 14b of cap end 14, wet pad 22
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`within chamber 16b and dry pad 24 within cavity 14b. Internal wall 12a separates
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`cap end 14 and cleaning end 16.
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`Cap/cleaner 10 is typically distributed and stored in a sterile, sealed package
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`2 o
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`either alone or paired with a patient fluid line access valve. One such type of valve
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`· is the BD Q-Syte™ valve from Becton, Dickinson and Company (illustrated in
`
`Figure 1 ). However, cap/cleaner 10 is useful with any type of needleless or needle(cid:173)
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`required access valve. Once removed from the package, cap/cleaner 10 is ready for
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`use.
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`25
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`Figure 3 illustrates cap/cleaner 10 covering access portion A 10 of access
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`valve A Septum A6 provides an accessible seal for either a needle or a male luer
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`taper. In the case of a needleless access device, such as that shown in Figure 3, slit
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`A8 extends through septum A6 to provide a port for insertion of the male luer taper.
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`4
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`As shown, cap end 14 includes cap 14a with cavity 14b, which contains dry
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`pad 24. Dry pad 24 is impregnated with an antimicrobial agent to aid in
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`maintaining antiseptic conditions of access portion AlO of valve A. Suitable
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`material for dry pad 24 includes non-woven material or a foam sponge pad made of
`
`s
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`polyurethane, polyester, cotton or any bioengineered plastic material such as
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`silicone. Any of a number of antimicrobial agents may be used to impregnate dry
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`pad 24. Some examples include chlorhexidine gluconate, chlorhexidine diacetate,
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`chloroxylenol, povidone iodine, Triclosan, benzethonium chloride, benzalkonium
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`chloride, octenidine, antibiotic, etc. Alternatively, cap end 14 does not contain dry
`
`10
`
`pad 24 and aids in maintaining antiseptic conditions by simply covering access
`
`portion Al0.
`
`In use, cap end 14 of cap/cleaner 10 is placed over access portion A 10 such
`
`that access portion A 10 is within cavity 14b of cap end 14. Cap/cleaner 10 may be
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`attached either prior to or after placement of valve A for the patient. As shown in
`
`1s
`
`Figure 3, valve A includes thread A4. By rotating cap/cleaner 10 or valve A
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`relative to one another, threads A4 and 18 ( of cap/cleaner 10) interlock to provide a
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`secured attachment. It is not necessary, however, for valve A to include thread A4.
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`Cap end 14 will also attach and hold a luer slip, which does not have a thread. In
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`other embodiments, cap/cleaner 10 may be manufactured without a thread.
`
`20
`
`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
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`space should be left in cavity 14b of cap end 14 for access portion A 10 of valve A
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`to be encompassed by cap end 14, thus, maintaining antiseptic conditions of the
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`surface. By maintaining antiseptic conditions of the surface, the risk of microbes
`
`2 s
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`penetrating into valve A is minimized.
`
`To further minimize the opportunity for penetration by microbes, access
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`portion Al 0 is cleaned prior to accessing valve A with a needle or male luer taper.
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`Figure 4 illustrates cap/cleaner 10 cleaning access portion Al0 of valve A.
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`5
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`As shown in Figure 4, cleaning end 16 includes hood 16a and chamber 16b,
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`which contains wet pad 22. Wet pad 22 is impregnated with a cleaning agent and
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`optionally, an antimicrobial agent. Wet pad 22 may be made from materials similar
`
`to those described for dry pad 24.
`
`5
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`The cleaning solution is typically an alcohol- or water-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 fragrance, dye,
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`surfactant, emollient, etc.
`
`1 o
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`Suitable water-based solutions contain about 1 % to about 10% alcohol
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`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 antimicrobial agents may be used in wet
`
`1s
`
`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
`
`2 o
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`hood of cleaning end 16 loosely encompasses at least access portion A 10 of valve
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`A, and chamber 16b is sized to allow some movement when access portion A 10 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
`
`2 s
`
`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
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`valve A does not have a thread. Lid 20 is removed from cleaning end 16. Cleaning
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`6
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`end 16 is.then placed over at least access portion A 10, such that wet pad 22 contacts
`
`septum A6. Though Figure 4 only shows contact with septum A6, additional
`
`pressure may be applied such that wet pad 22 extends beyond the edges of septum
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`A6 to contact portions of the exposed surface of housing A2.
`
`5
`
`Next, for thorough cleaning, wet pad 22 should scrub access portion A 10 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 AIO of valve A.
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`Once cleaned, valve A is ready to use. A needle or male luer taper is
`
`1 o
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`inserted to either infuse or withdraw fluid from the patient fluid line.
`
`Figure 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
`
`withdrawal after accessing the patient fluid line, access portion Al 0 of valve A may
`
`15
`
`either be immediately capped or cleaned again prior to capping.
`
`If immediately
`
`capped, a new, second cap/cleaner 1 0a is obtained and removed from its package.
`
`This is represented by step 40. Cap end 14 of cap/cleaner 1 0a is placed over access
`
`portion Al Oas described above. Cleaning end 16 of cap/cleaner 1 0a is sealed and
`
`ready for the next time valve A is utilized.
`
`20
`
`Alternatively, access portion AIO 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 A 10, 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 1 0a is used to clean access portion
`
`25 AIO. 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
`
`A 10 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
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`7
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`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. Figure 6 shows separable cap/cleaner 56. Separable
`
`s
`
`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.
`
`Figure 7 shows separable cap/cleaner 56 in more detail and further includes
`
`dry 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
`
`10
`
`cap/cleaner 10 except that cleaning end 60 may be removed after cleaning access
`
`portion AlO of valve A. Detaching cleaning end 60 reduces bulkiness from
`
`separable cap/cleaner 56 by only maintaining cap end 58 over access portion AI0.
`
`Figure 8 shows a representative embodiment of breakable connector 68.
`
`Connector 68 is typically made of the same material from which housing 12 is
`
`1s
`
`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(cid:173)
`
`point bending force, which consists of a fulcrum ( connector 68) that directs a force
`
`vector contralateral to the direction of the terminal ( cap end 5 8 and cleaning end 60)
`
`force vectors, may be applied for breaking connector 68. Once removed, cleaning
`
`2 o
`
`end 60 may be discarded.
`Figure 9 is an alternate embodiment showing notched breakable connector
`70. Notch 72 within connector 70 is an area ofreduced cross-sectional area, which
`
`acts as a score to facilitate breaking of connector 70.
`
`Other separation mechanisms may also be used to remove cleaning end 60
`
`2s
`
`from cap end 58. For instance, a luer lock type mechanism can be utilized to
`
`separate ends 58 and 60 from each other.
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`8
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`Figure 1 OA shows a representative embodiment of cleaning device 7 4 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.
`
`Figure 1 OB shows a representative embodiment of cap device 78 with lid
`
`s
`
`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
`
`portion AIO of valve A in addition to its capping function. The twisting motion
`
`10
`
`involved in removing and placing cap device 78 with respect to access potion Al 0
`
`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.
`
`With either cleaning device 7 4 or cap device 78, additional gripping surface
`
`1s 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 microbes into the access valves, particularly for needleless access valves.
`
`2 o
`
`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.
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`9
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`CLAIMS:
`
`1.
`
`A device for antiseptically maint