`
` Utility Patent Application Transmittal
`
`
`
`Docket Number
`
`1 131-024.204
`
`
`
`
`
`Address To
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`First Named Inventor
`
`Mailing Address
`Danziger Strasse 2
`City —-—
`—M Postal Code
`34587
`City of Residence
`State of Residence
`Country of Residence Germany
`Citizenship
`Title of Invention
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`United States of America
`
`Assignee Information“
`
`B. BRAUN MELSUNGEN AG
`
`e
`
`C2 rl-Bra un‘Strasse 1
`
` ity
`
`State
`“W Postal Code
`*Complete this section if applicant wants the patent application publication to include assignee information. Providing this information
`does not substitute for compliance with any requirement of Part 3 of 37 CFR to have an assignment recorded by the Patent Office.
`
`Application Elements
`See MPEP chapter 600 concerning utility patent application contents.
`1. E] USPTO Filing Fee (as calculated infra)
`.
`Application Data Sheet (37 CFR 1.76)
`2
`. I] Applicant claims small entity status
`,
`CD-ROM or CD-R in duplicate, large table or
`Computer Program (Appendix)
`See 37 CFR 1.27
`U Landscape Table on CD
`
`.
`
`Specification
`Total number of pages
`Both the claims and abstract must start on a new page
`(Foriniormation on the preferred arrangement. see MPEP 608mm)
`
`b. E]
`
`Nucleotide andlor Amino Acid Sequence Submission
`(if applicable, items a. ' Q are required}
`a. D Computer Readable Form (CRF)
`
`b.
`
`Specification Sequence listing on:
`i. D CD-ROM or CD-R (2 copies), or
`ii. D Paper
`c, E]
`Statements verifying identity of above copies
`
`.
`
`.
`
`Drawing(s) (35 USC. 113)
`Total number of sheets
`Oath orDeclaration
`Newly executed (original or copy), or D Unexecuted
`A copy from a prior application (37 CFR i.63(d))
`(for Continuation or Divisional Application)
`
`10
`
`a.
`
`i. [j DELETlON OFlNVENTOR(S)
`Signed statement attached deleting inventor(s)
`named in the prior application (see 37 CFR
`1,63(d) and i.33(b).)
`
`Page 1 of 4
`
`1
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`B. Braun 2003
`
`1
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`B. Braun 2003
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`

`

`Utility Patent Application Transmittal &W
`
`1 131-024.204
`
`Accompanying Application Parts
`
`18. El Certificate of Mailing
`9. D Assignment
`a. E First Class Mail. or
`a. D Recordation Form Cover Sheet
`b. D Express Mail
`37 CFR 3.73(b) Statement (when there is an assignee)
`Label Number
`Via EFS
`
`10.
`
`11_
`
`12.
`
`13.
`
`DUDEEDGE
`
`Power of Attorney
`
`E] No Power of Attorney
`
`19
`
`Other'
`
`Certification and Request for Prioritized
`Examination Under 37 CFR 1.l02(e) (] page)
`
`English Translation Document (if applicable)
`
`Information Disclosure Statement
`
`a. m Copies of citations attached
`
`Preliminary Amendment
`
`Return Receipt Postcard (MPEP 503)
`(Should be specifically itemized)
`Certified Copy of Priority Documentis)
`(if foreign priority is claimed)
`Nonpublication Request under 35 USC 122(b)(2)(B)(i)
`
`
`
`in abandonment of this application (35 U.S.C. 122(b)(2)(B)(iii)).
`
`20.
`
`If a CONTINUING APPLICATION, check appropriate box, and supply the requisite information below and in the first
`sentence of the specification following the title, or in an Application Data Sheet under 37 CFR 1. 76:
`
`Continuation D Divisional D Continuation-in—part(ClP) of prior application No.
`
`13/667,261
`(XX/WY,YYY)
`
`Prior application information:
`
`Examiner
`
`Not Yet Assigned
`
`Art Unit:
`
`Not Yet Assigned
`
`Request Not To Publish“
`21. D Applicant hereby requests that the attached application not be published under 35 USS. 122(b).
`Applicant hereby certifies that the invention disclosed in the attached application has not and will not be the
`subject of an application filed in another country, or under a multilateral international agreement, that requires
`publication at eighteen months after filing.
`
`*Warning
`This request must be signed in compliance with 37 CFR 1.33(b) and submitted with the application upon filing.
`
`If applicant rescinds a request that an application not
`Applicant may rescind this nonpublication request at any time.
`be published under 35 U.S.C. 122(b), the application will be scheduled for publication at eighteen months from the
`earliest claimed filing date for which a benefit is claimed.
`
`lf applicant subsequently files an application directed to the invention disclosed in the attached application in
`another country, or under a multilateral international agreement, that requires publication of applications eighteen
`months after filing, the applicant must notify the United States Patent and Trademark Office of such filing within
`forty-five (45) days after the date of the filing of such foreign or international application. Failure to do so will result
`
`pursuant to 37 CFR 1.219 as provided in 37 CFR 1.215(0).
`
`Request To Publish Early
`Applicant hereby requests the publication of this patent application earlier than as set forth in 37 CFR 1.211(a)
`
`22,
`
`Page 2 of 4
`
`2
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`

`

` Utility Patent Application Transmittal
`
`
`
`Docket Number
`
`1 131324.204
`
`Fee Calculation
`
`
`Utility Patent Application Fee
`Claims as Filed
`
`
`
`
`
`For
`Totalcraims
`Total lndep. Claims
`
`#Filed
`
`#Allowed
`
`Rate
`x 62 =
`x 250 =
`— 3 =
`Multiple Dependent Claims (check if applicable)
`
`_
`
`
`
`
`
`
`
`
`
`Fee
`$620
`
`$0
`
`D E-Filin small enti must be selected to at Filino Fee discount Basic Filin Fee
`Number of Specification Pages
`Number of Drawing Sheets
`Total Pages
`Application Size Fee
`
`32
`
`Pre-Grant Publication Fee
`a
`
`tion fee as set forth in 37 CFR 1.18(d)
`
`Early publi
`
`2E!
`
`$300
`
`
`
`
`
`
`
`Processing fee for publication or repubiication as set forth in 37 CFR 1.170)
`
`
`
`Assignment Recordal Fee
`Examination Feel
`
`
`Enter Number of Properties Affected by Recordal
`
`
`Examination Feei$250
`
`
`
`
`
`Search Fee
`
`Search Fee
`
`TOTAL
`
`$620
`
`$2180
`
`x 40
`
`
`
`Method of Payment
`
`
`[I Deposit Account m Credit Card D Check E] Money Order D Other;
`11-1159 —
`DepositAccount Number
`
`
`For the above-identified deposit account, the Director is hereby authorized to: (check all that apply)
`
`
`
`
`
`
`
`
`
`
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`Er] Charge any additional fee(s) or underpayments of fee(s) under 37 CFR 1.16 and 1.17
`D Charge fee(s) indicated above, except for the filing fee
`m Credit any overpayments
`WARNING: Information on this form may become public. Credit card information should not be included
`on this form. Provide credit card information and authorization on form PTO-2038.
`Amount Grand Total
`
`
`$2180
`
`
`
`
`
`
`
`
`
`Page 3 of 4
`
`3
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`

`

`
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`Utility Patent Application Transmittal
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`I hereby certify that this Patent Application, accompanying documents. and fee
`are being deposited with the United States Postal Service with sufficient postage
`as first class mail in an envelope addressed to Commissioner for Patents, PO.
`Box 1450, Alexandria, Virginia 22313—1450 on the date indicated below:
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`CATHETER ASSEMBLY AND COMPONENTS THEREOF
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`1
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`I
`rLegal Name
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`
`
`I Kevin I Woehr I
`
`Residence Information (Select One) 0 US Residency @ Non US Residency Q Active US Military Service
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`City
`[Felsberg
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`Efzestrasse 4
` Address 1
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`Address 2
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`City
`1 Wabem
`I—StatelProvince
`
`r—
`.
`L-
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`Postal Code 1 DE :1 34590 ICountryl
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`Correspondence Information:
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`
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`
`Mailing Address of Inventor:
`
`Danziger Strasse 2
`
`I
`
`Address 1
`Address 2
`I
`{StatelProvince
`J Feisberg
`City
`
`Countryi
`DE
`Postal Code
`
`
`Inventor 2
`Legal Name
`
`Prefix Given Name
`Middle Name
`Family Name
`Suffix
`
`
`Michael
`Zerbes
`
`Residence Information (Select One) 0 US Residency @ Non US Residency 0 Active US Military Service
`
`City Wabern
`Country of Residence
`g
`1 DE
`‘3
`1
`
`
`
`
`
`5
`
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`

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`CATHETER ASSEMBLY AND COMPONENTS THEREOF
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`LAttorney Docket Number Hat—024.204
`Email Entity Status Claimed
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`1 Continuation of
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`2012-11—02
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`a. BRAUN MELSUNGEN AG
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`l Melsungen
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`
`Countryl
`DE
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`34212
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`Can—Braunosnasse 1
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`Tom
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`Attorney Docket No: l 131~024.204
`Via EFS
`
`CATHETER ASSEMBLY AND COMPONENTS THEREOF
`
`CROSS-REFERENCE TO RELATED APPLICATION
`
`[0001]
`
`This is a continuation of application Ser. No. 13/667261, filed November 2.
`
`2012, bearing Attorney Docket No. 1131-024203, which is a continuation of application Ser.
`
`No. 13/407,395, filed February 28. 2012. which is a continuation application of application Ser.
`
`No. 12‘768,155,
`
`filed April 27, 2010, which is a continuation of application Serial No.
`
`11/592,595. filed on November 3, 2006, the entire contents of which are hereby expressly
`
`incorporated herein by reference.
`
`Technical Field
`
`[0002}
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`Catheter assemblies are generally discussed herein with particular discussions
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`extended to catheter assemblies having a tip protector. a valve, a valve opener, and optionally a
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`needle wiper.
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`BACKGROUND
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`[0003]
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`Insertion procedure for an IV catheter assembly contains four basic steps: (1) the
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`healthcare worker inserts the needle and catheter together into the patient‘s vein; (2) after
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`insertion into the vein with the needle point. the catheter is forwarded into the vein of the patient
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`by the healthcare worker pushing the catheter with his or her finger; (3) the healthcare worker
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`withdraws the needle by grasping the hub end (opposite the point end) while at the same time
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`applying pressure to the patient's skin at the insertion site with his or her free hand to stop the
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`flow of blood through the catheter; and (4) the healthcare worker then tapes the exposed end of
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`the catheter (the catheter hub) to the patient's skin and connects it to the source of the fluid to be
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`administered into the patient's vein.
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`[0004]
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`The problem is that, immediately after the withdrawal of the needle from the
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`patient's vein.
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`the healthcare worker, who is at
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`this time involved in at
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`least
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`two urgent
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`procedures, must place the exposed needle tip at a nearby location and address the tasks required
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`to accomplish the needle withdrawal.
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`It is at this juncture that the exposed needle tip creates a
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`danger of an accidental needle stick. which, under the circumstances,
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`leaves the healthcare
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`worker Vulnerable to the transmission of various dangerous blood-borne pathogens, including
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`AIDS and hepatitis.
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`10
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`10
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`

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`Attorney Docket No: l 131-024204
`Via EFS
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`[0005]
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`Other needle types similarly expose healthcare workers to risks of accidental
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`needle sticks. For example. a doctor administering an injection. using a straight needle. a Huber
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`needle. an epidural needle, etc.. may place the used needle on a tray for subsequent disposal by a
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`nurse. For the period between placing the used needle on a tray or a work station to the time it is
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`discarded. the used needle is a potential source for disease transmissions for those that work near
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`or around the needle.
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`[0006]
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`Accordingly, all needles should be covered immediately following use to ensure
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`greater worker safety.
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`Ideally. the procedure for covering the needle tip should be passive. self
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`activating, or at least simple to perform.
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`In addition, the device for covering the needle should
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`be reliable and robust.
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`{0007]
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`More advantageously. a valve should be incorporated in the catheter assembly to
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`minimize blood exposure following successful catherization.
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`In addition. as blood comes in
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`contact with the needle and is deposited on the needle, the needle assembly should further
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`incorporate means for wiping the needle of the deposited blood upon retracting the needle.
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`SUMMARY
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`[0008]
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`In accordance with aspects of the present invention, there is provided a catheter
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`assembly comprising: a first hub comprising a housing comprising an exterior surface and an
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`interior surface defining an interior cavity; a tube attached to the first hub and extending distally
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`of the first hub; a second hub comprising a housing comprising an exterior surface and an
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`interior surface defining an interior cavity; a needle having a needle tip attached to the second
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`hub and projecting distally of the second hub and into the tube; a valve comprising a top surface.
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`a skirt depending therefrom. and an opening on the top surface having the needle projecting
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`therethrough; a valve opener comprising an actuating end. at least one leg extending proximally
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`therefrom. and a wiper comprising a perimeter defining an opening and the needle in contact
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`with the perimeter for wiping the needle as the needle is retracted away from the tube.
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`[0009]
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`Other aspects of the present invention include a catheter assembly comprising: a)
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`a catheter hub comprising a housing comprising an exterior surface and an interior surface
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`defining an interior cavity; b) a catheter tube attached to the catheter hub and extending distally
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`of the catheter hub; c) a needle hub comprising a housing; d) a needle having a needle tip
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`attached to the needle hub and projecting distally of the needle hub and into the catheter tube; e)
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`[\J
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`11
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`11
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`

`

`Attorney Docket No: l 131024.204
`Via EFS
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`a valve for limiting blood backflow positioned in the interior cavity of the catheter hub; f) a
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`valve opener for opening the valve positioned proximally of the valve; and g) a tip protector
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`positioned adjacent the valve opener for blocking the needle tip. wherein the tip protector
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`comprises: (1) a tip protector housing having an interior surface; (2) a first arm extending from a
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`distal wall of the tip protector housing biased towards the interior surface of the catheter hub; {30)
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`a second arm extending from a proximal wall of the tip protector housing biased towards the
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`interior surface of the catheter hub; and (4) a third arm extending from the proximal wall of the
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`tip protector housing biased against a side of the needle.
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`[0010]
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`In accordance with other aspects of the present invention, there is provided a
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`catheter assembly comprising: a catheter hub comprising a housing defining an interior cavity
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`and having a catheter tube extending distally thereof; a needle hub comprising a housing defining
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`an interior cavity and having a needle having a needle tip extending distally thereof; the needle
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`projecting into the catheter tube; a hemostatic valve positioned within the interior cavity of the
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`catheter hub having an opening; a valve opener positioned adjacent the hemostatic valve and
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`comprising an actuating end comprising a cone section and a pair of legs defining a gap
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`extending proximally thereof; a wiper having the needle passing therethrough for wiping the
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`needle as the needle is retracted from the catheter tube; and wherein a tip protector comprising an
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`arm and a wall comprising an opening and is positioned in the gap defined by the two legs.
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`[0011]
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`In accordance with other aspects of the present invention, there is provided a
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`method of wiping blood from a needle during a process of emplacing a catheter using a catheter
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`assembly. The method comprises puncturing a person’s vasculature with a sharp distal tip of the
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`needle of the catheter assembly. The needle extends distally from a first hub including a housing
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`having an exterior surface and an interior surface defining an interior cavity. The method further
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`comprises penetrating the vasculature with the catheter of the catheter assembly. The catheter is
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`disposed about the needle and extends distally from a second hub including a housing having an
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`exterior surface and an interior surface defining an interior cavity. The first and second hubs
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`releasably engage one another. The method further comprises withdrawing the needle from the
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`vasculature while maintaining the catheter within the vasculature by disengaging the first hub
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`from the second hub and moving the first hub proximally with respect to the second hub. The
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`proximal movement causes the needle to withdraw from the catheter. The method further
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`comprises wiping blood from the needle as it withdraws by passing the needle through a wiper.
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`DJ
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`12
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`12
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`

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`Attorney Docket No.: 1131-0241204
`Via EF S
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`The wiper has a continuous perimeter defining an opening. The perimeter is in contact with the
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`needle for wiping the needle.
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`[0012]
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`In accordance with other aspects of the present invention. there is provided a
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`method of cleaning an exterior of a needle during a process of emplacing a catheter using a
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`catheter assembly. The method comprises inserting the needle of the catheter assembly into a
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`person’s vasculature at an access site. The needle extends distally from a proximal hub. The
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`method further comprises inserting the catheter of the catheter assembly into the vasculature at
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`the access site. The catheter is disposed about the needle and extends distally from a distal hub.
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`The proximal and distal hubs releasably engage one another. The method further comprises
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`disengaging the proximal hub from the distal hub and moving the proximal hub proximally with
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`respect to the distal hub. The proximal movement draws the needle out of the vasculature and
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`the catheter while the catheter remains within the vasculature. The method further comprises
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`passing the needle through a wiper as it withdraws. The wiper removes blood from the exterior
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`of the needle. The wiper has a continuous perimeter defining an opening. The perimeter is in
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`contact with the exterior of the needle for wiping the needle.
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`[0013]
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`Still yet
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`in accordance with other aspects of the present
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`invention include
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`provisions for registering a pair of legs on the valve opener to the catheter hub by formng two
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`axially extending undercut within the interior wall surface of the catheter hub for cooperating
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`with the two legs.
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`[0014]
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`In a preferred embodiment of the present invention. a raised bump or projection is
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`formed within the interior cavity of the catheter hub for retaining a tip protector within the
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`catheter hub during retraction of the needle hub away from the catheter hub.
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`[0015]
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`In yet other aspects of the present invention. a wiper in the form of an O-ring is
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`used to wipe the needle from blood deposits.
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`[0016]
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`Other aspects and features of the catheter assemblies provided herein may be
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`better appreciated as the same become better understood with reference to the specification.
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`claims, and appended drawings.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0017]
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`The appended drawings include:
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`13
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`

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`Attorney Docket No.: l 131024.204
`Via EFS
`
`[0018]
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`FIG.
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`I
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`is a cross-sectional side view of a catheter assembly provided in
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`accordance with aspects of the present invention:
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`[0019]
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`FIG. 2 is a cross-sectional side view of the catheter of FIG. 1 with the needle and
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`needle hub removed therefrom:
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`[0020]
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`FIG. 3 is a partial cross-sectional side view ofa safety catheter assembly provided
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`in accordance with aspects of the present invention. which includes a valve. a valve opener. and
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`a tip protector;
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`[0021]
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`FIG. 4 is a partial cross-sectional side view of the safety catheter assembly of
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`FIG. 3 with the needle hub, needle. and tip protector removed therefrom;
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`[0022]
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`FIG. 5A is a cross~sectional side View of the catheter assembly of FIG. 4 with an
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`IV set luer connector coupled to the catheter hub and pushing a valve opener distally into the
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`valve;
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`[0023]
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`FIG. 5B is a cross-sectional side View of an alternative catheter assembly. similar
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`to the assembly of FIGS. 3—5A. wherein the valve opener does not incorporate barbs to permit
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`disengagement with the valve upon retraction of the IV-set luer connector;
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`[0024]
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`FIG. 6 is a cross-sectional side view of a needle hub and needle with a tip
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`protector covering the needle tip;
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`[0025]
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`FIG. 7 is a perspective view of the tip protector of FIG. 6;
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`[0026]
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`FIG. 8A is a plan View of a wiper provided in accordance with aspects of the
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`present invention, which includes two cut—outs;
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`[0027]
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`FIG. SB is a perspective view of a valve opener provided in accordance with
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`aspects of the present invention having a wiper. according to FIG. 8A. attached to a proximally
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`facing attachment surface;
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`[0028]
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`FIG. 8C is a cros