(19) United States
`(12) Reissued Patent
`Crawford et al.
`
`USOORE38996E
`
`US RE38,996 E
`(10) Patent Number:
`Feb. 28, 2006
`(45) Date of Reissued Patent:
`
`(54) NEEDLE TIP COVER
`(75) Inventors: Mark A. Crawford, Sandy, UT (US);
`Timothy J. Erskine, Sandy, UT (US);
`Gerald H. Peterson, Salt Lake City,
`UT (US)
`(73) Assignee: Becton, Dickinson and Company,
`Franklin Lakes, NJ (US)
`
`(21) Appl. No.: 09/249,301
`(22) Filed:
`Feb. 11, 1999
`Related U.S. Patent Documents
`
`5,601,536
`Feb. 11, 1997
`08/463,618
`Jun. 5, 1995
`
`Reissue of:
`(64) Patent No.:
`Issued:
`Appl. No.:
`Filed:
`U.S. Applications:
`(62) Division of application No. 08/364,071, filed on Dec. 27,
`1994, now Pat. No. 5,558,651, which is a continuation of
`application No. 08/114.988, filed on Aug. 12, 1993, now
`abandoned, which is a continuation of application No.
`07/512,284, filed on Apr. 20, 1990, now abandoned.
`(51) Int. Cl.
`A6IM 5700
`
`(2006.01)
`
`(52) U.S. Cl. ................... 604/263; 604/166.01; 604/198
`(58) Field of Classification Search ................. 604/110,
`604/162, 164, 166, 167, 168, 192, 197, 198,
`604/263, 53,272; 128/919
`See application file for complete Search history.
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`:
`
`3/1959 White
`2.876,770 A
`3,008,570 A * 11/1961 Roehr et al.
`3,052.241 A * 9/1962 Myerson et al.
`3,134,380 A * 5/1964 Armao
`3,354,881. A * 11/1967 Bloch
`
`
`
`AMENDED
`
`3.370,588 A * 2/1968 Burke
`3,401,693 A * 9/1968 Cohen
`3,468.309 A * 9/1969 Drewe
`3.884.230 A * 5/1975 Wulff
`3,904,033 A * 9/1975 Haerr
`4,139,009 A * 2/1979 Alvarez
`4,237.882 A * 12/1980 Wickham
`4,356,822 A * 11/1982 Winstead-Hall
`4.425,120 A * 1/1984 Sampson et al.
`4,553,962 A * 11/1985 Brunet
`4,573,981. A * 3/1986 McFarlane
`4,610,671. A * 9/1986 Luther
`4,631,057 A * 12/1986 Mitchell
`4,634,428 A * 1/1987 Cuu
`4,643,722 A * 2/1987 Smith, Jr.
`4,650,468 A * 3/1987 Jennings, Jr.
`4,659,330 A * 4/1987 Nelson et al.
`4,660,570 A * 4/1987 Dombrowski
`4,664.259 A * 5/1987 Landis
`4,664,653 A * 5/1987 Sagstetter et al.
`4.675,005 A * 6/1987 Deluccia
`(Continued)
`FOREIGN PATENT DOCUMENTS
`
`EP
`O344606 A2 12/1989
`Primary Examiner Sharon Kennedy
`(74) Attorney, Agent, or Firm Mony R. Ghose
`(57)
`ABSTRACT
`A needle and a cover with a needle having an elongate Shank
`and a tip with a sharpened point. The cover is coaxially
`asSociated with the elongate Shank for movement there along
`toward the tip and includes a part for extending beyond the
`Sharpened point when the cover is positioned near the tip. A
`lock associated with the needle and cover cooperates with
`and holds the cover to prevent axial movement relative to the
`needle tip after positioning the cover near the tip. A retaining
`member on the adapter and on the cover releasably attach the
`cover to the adapter while on the elongate Shank of the
`needle allowing the needle and cover to be disengaged from
`the catheter and adapter after placement.
`
`10 Claims, 9 Drawing Sheets
`
`1
`
`B. Braun 2014
`
`

`

`US RE38,996 E
`Page 2
`
`U.S. PATENT DOCUMENTS
`:
`: A : 8 , Sanderer et al.
`4723,943 A
`3.E. S.
`eCe.
`2 1-2
`p
`4,725,267 A * 2/1988 Vaillancourt
`4,731,059 A * 3/1988 Wanderer et al.
`:
`4,735,618 A 4/1988 Hagen
`:
`4,740.205 A 4f1988 Seltzer et al.
`:
`4,743,233 A 5/1988 Schneider
`4,755,170 A * 7/1988 Golden
`:
`4,762,516 A 8/1988 Luther et al.
`4,772.272 A * 9/1988 McFarland
`4,775,367 A * 10/1988 Schmidt
`2
`- 2
`:
`4,775,369 A 10/1988 Schwartz
`4,781,692 A 11/1988 Jagger et al. ............... 604/164
`:
`4,846,804 A 7/1989 Davis et al.
`4,846,805. A * 7/1989 Sitar
`4,846,811 A 7/1989 Vanderhoof................. 604/263
`:
`4,850,961 A 7/1989 Wanderer et al.
`4.850,977 A * 7/1989 Bayless
`:
`4,904.244. A 2/1990 Harsh et al.
`4,911,694. A * 3/1990 Dolan
`4929,241 A * 5/1990 Kulli
`4,935,012 A * 6/1990 Magreet al.
`
`4,952.207 A * 8/1990 Lemieux
`4.955.866 A * 9/1990 Corey
`4,964,854. A * 10/1990 Luther
`4,973,317 A * 11/1990 Bobrove
`4,990,141. A * 2/1991 Byrne et al.
`:
`4,994,041 A 2/1991 Dombrowski et al.
`:
`5O15242 A 5/1991 Heifetz
`2Y-----
`:
`5,049,136 A 9/1991 Johnson
`2Y- - - 2
`:
`5,051.109 A 9/1991 Simon
`2Y- - -a-
`:
`5,053,017 A 10/1991 Chamuel
`2Y- - -2
`:
`5,059,180 A 10/1991 McLees
`2Y- - - 2
`:
`5,059.184 A 10/1991 Dyke
`2Y- - - 2
`5,085,648 A 2/1992 Purdy et al. ................ 604/198
`5,135,504 A * 8/1992 McLees
`2-a-s-s-s
`:
`5,135,505 A 8/1992 Kaufman
`2-a-s-s-s
`5,137.515 A 8/1992 Hogan ........................ 604/110
`2-a-s-
`:
`5,169,391 A 12/1992 Vogel
`2-Y/ -- a
`:
`5,176,655 A 1/1993 McCormick et al.
`2- . 12
`:
`5,183,468 A 2/1993 McLees
`2-Y-2
`5,195,974 A 3/1993 Hardy ........................ 604/110
`5,215.528 A * 6/1993 Purdy et al.
`5,328,482 A * 7/1994 Si
`tal
`2-1-12
`CO e a
`
`* cited by examiner
`
`2
`
`

`

`U.S. Patent
`
`Feb. 28, 2006
`
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`Feb. 28, 2006
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`Feb. 28, 2006
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`Feb. 28, 2006
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`U.S. Patent
`
`Feb. 28, 2006
`
`Sheet 9 of 9
`
`US RE38,996 E
`
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`
`11
`
`

`

`1
`NEEDLE TIP COVER
`
`US RE38,996 E
`
`appears in the
`Matter enclosed in heavy brackets
`original patent but forms no part of this reissue specifi
`cation; matter printed in italics indicates the additions
`made by reissue.
`This application is a division of patent application Ser.
`No. 08/364,071 filed Dec. 27, 1994, now U.S. Pat. No.
`5,558,691, which is a continuation of patent application Ser.
`No. 08/114,988 filed Aug. 12, 1993, now abandoned, which
`is a continuation of patent application Ser. No. 07/512,284
`filed Apr. 20, 1990, now abandoned.
`FIELD OF THE INVENTION
`This invention relates to a needle tip cover to prevent
`transmission of infection and more particularly, relates to a
`tip cover for locking about the tip of a disposable needle
`after use to prevent accidental delivery of infectious organ
`isms by penetration of the used needle tip into an animal.
`BACKGROUND OF THE INVENTION
`With concern about infection, transmission of AIDS,
`hepatitis and Similar incurable diseases of the blood, meth
`ods and devices to enclose the used disposable needle tip
`have become very important and in great demand. Many
`approaches to guard the needle, protect users and/or other
`wise prevent injury have been proposed. All of them are
`cumberSome, expensive and interfere with the normal and
`accepted procedure for the insertion of an over the needle
`catheter. Typical of such introducers is U.S. Pat. No. 4,846,
`805 wherein the shield slides over the flash chamber body to
`engage the catheter and lock about the used needle tip.
`Specifically, after the catheter has been inserted by an
`over the needle procedure and blood flashback has been
`observed, the catheter is advanced and/or the needle is
`withdrawn. After the catheter is inserted into the vessel as
`desired and the needle is withdrawn and discarded, protec
`tion of the used needle tip becomes important. Needle
`guards are of three types which either hide the withdrawn
`needle within the needle carrying hub, require replacement
`of a separate needle guard or include a sliding Shield which
`can be positioned distally over the used needle. Some of
`these types of guards lock to Secure the guard in the needle
`protecting position thereby preventing injury.
`Those needle guards are cumberSome and interfere with
`the Single hand over the needle catheter placement proce
`dure as disclosed in Stanley, U.S. Pat. No. 3,714,945. The
`needle tip cover disclosed herein does not interfere with or
`require any additional Steps, procedures or cumberSome
`mechanisms which interfere with the accepted over the
`needle technique.
`U.S. Pat. No. 3,134,380 has a needle shield for a hypo
`dermic needle and that needle shield is not provided to
`prevent infection but is included to preserve Sterility and to
`hide the needle prior to use. The device therein includes a
`compressible resilient sleeve which is carried on the distal
`end of a Syringe barrel to extend outwardly therefrom over
`the needle and its tip. The sleeve is axially collapsible during
`placement of the needle in the vessel and reextends due to
`the resilience of the sleeve as the needle is extracted from the
`vessel. The distal end of the sleeve is arranged to be carried
`about the needle and in its extended position rests beyond
`the tip. No means of locking the sleeve in the extended
`position is disclosed.
`U.S. Pat. No. 4,846,804 has a needle tip protector with a
`collapsible sleeve disposed about the shank of the needle
`
`15
`
`25
`
`35
`
`40
`
`45
`
`50
`
`55
`
`60
`
`65
`
`2
`and a protective cap located at the distal end thereof. The cap
`Surrounds and encloses the tip of the needle. A Sealing
`member is located within the cap to enclose the tip until the
`needle is pushed through the Sealing member. Similarly,
`U.S. Pat. No. 3,354,881 has a compressible device extending
`over the needle shank. Rubber septa are provided at the
`opposite ends of the compressible device So as to Surround
`the needle.
`U.S. Pat. No. 4,139,009 has a needle tip protector with a
`permanently attached cover Surrounding the needle and a
`number of elastic arms which extend along the length of the
`needle. The arms are constructed So as to bow outwardly
`from the needle Shank when the needle is pressed against
`and into the patient. U.S. Pat. No. 4,660,570 shows a needle
`tip protector with a membrane extending over the Sharp
`point of the needle whereby penetration causes the needle to
`extend through the membrane and the skin of the patient.
`U.S. Pat. No. 4,650,468 has a device with a sleeve
`concentrically placed about the needle Shank. Asafety shield
`at one end has a rubber membrane extending acroSS an
`opening in the Shield. The membrane is adapted to be
`pierced by the needle tip for use.
`SUMMARY OF THE INVENTION
`The invention most preferably is a needle and cover for
`use with a needle having an elongate Shank relative to an
`axis thereof. The needle has a tip at one axial end with a
`Sharpened point. The cover is coaxially associated with the
`elongate Shank for Sliding movement there along toward the
`tip. The cover includes a part for extending along the axis
`beyond the sharpened point when the cover is positioned
`near the tip. A lock associated with the needle and the cover
`cooperates and holds the cover to prevent axial movement of
`the cover relative to the needle tip after the cover is
`positioned distally along the elongate Shank near the tip with
`the part that extends over the Sharpened point.
`The cover may have a bearing for circumscribing and
`guiding during coaxial sliding on the elongate Shank. The
`part which extends hangs cantilever off the bearing to extend
`beyond the Sharpened point preventing accidental injury.
`The lock may have a change in contour of the needle near
`where the elongate Shank joins the tip So when the cover
`interengages with the change in contour it becomes locked
`relative to the needle preventing further axial movement.
`The bearing has an inside diameter which most preferably
`rides upon the Shank for axial movement therealong and the
`bearing is Such that engagement with the change in contour
`prevents distal travel. The part which extends controls the
`proximal axial movement of the cover up the elongate Shank
`away from the tip after thus locking the cover near the tip.
`The change of contour may be a transition between a
`reduced diameter of the elongate Shank and an enlarged
`diameter of the tip, a roughened Surface on the needle, a
`change in croSS Section from a circular croSS Section for the
`elongate Shank to a non-circular croSS Section near the tip or
`a notch which extends into the needle providing a latch face
`for a pawl on the cover.
`The invention may be a part of a catheter assembly having
`a catheter and an adapter connected to one another for fluid
`communication and carried coaxially about a needle and
`hub. The catheter has a bore therethrough sized to surround
`the elongate shank of the needle for movement therewith
`during insertion and there along during placement. A retain
`ing means on the adapter and on the cover may releasably
`attach the cover to the adapter while the catheter and adapter
`are on the elongate Shank of the needle. The retaining means
`
`12
`
`

`

`3
`permit the needle and cover to be disengaged from the
`catheter and adapter after placement of the catheter in the
`vessel. The lock cooperates and Secures the cover to prevent
`the cover from axial movement relative to the needle tip
`after the cover is positioned near the tip.
`The invention further includes a method of assembly of
`the hub and cover to the needle. The Steps of placing the
`cover coaxially about the elongate Shank with the bearing
`thereof axially slidable there along toward the tip and Secur
`ing the hub to the end of the elongate shank over which the
`bearing was placed thereby capturing the cover between the
`tip and the hub.
`A method of inserting the over the needle catheter assem
`bly is a part of the invention. The preferred method has the
`Steps of applying pressure to the catheter assembly to
`penetrate the skin of the animal with the tip of the needle and
`carry the distal part of the coaxially positioned catheter into
`the body, inserting the catheter further with an over the
`needle procedure by holding the hub thereof between a
`finger and the thumb of the user and moving the cover
`axially along the needle from the hub to the tip with another
`finger while withdrawing the hub and needle from the
`inserted catheter and adapter with the other finger and
`thumb.
`BRIEF DESCRIPTION OF THE DRAWINGS
`FIG. 1 is a side view of a catheter assembly with a needle
`tip cover on the needle Shank between the catheter adapter
`and the needle hub and wherein the needle is fully seated
`within the catheter.
`FIG. 2 is a view of the needle tip cover of FIG. 1 shown
`in a croSS Section taken along line 2-2 of FIG. 1,
`FIG. 3 is a view of the needle tip cover of FIG. 1 shown
`in croSS Section as in FIG. 2 except the needle is shown
`partially withdrawn from the catheter.
`FIG. 4 is a view of the needle tip cover of FIG. 1 shown
`in cross section as in FIGS. 2 and 3 except the needle is
`shown mostly withdrawn from the catheter.
`FIG. 5 is a side view of a catheter assembly of an alternate
`needle tip cover located between the needle hub and the
`catheter adapter and wherein the needle is fully Seated
`within the catheter.
`FIG. 6 is a view of the alternate needle tip cover of FIG.
`4 shown in croSS Section.
`FIG. 7 is a view of the alternate needle tip cover of FIG.
`4 shown in croSS-Section as in FIG. 6 except the needle is
`shown partially withdrawn from the catheter.
`FIG. 8 is a view of the needle tip cover of FIG. 4 shown
`in cross section as in FIGS. 6 and 7 except the needle is
`shown mostly withdrawn from the catheter.
`FIG. 9 is an enlarged side view in partial cross section of
`the cover; the needle tip and a portion of the elongate Shank
`are locked in the cover by the part which extends and one
`form of the change in contour between the enlarged tip and
`a reduced diameter elongate Shank.
`FIG. 10 is an enlarged side view partially in cross section
`of the cover wherein another form of the change in contour
`between the elongate Shank and the tip is shown as a
`roughened Surface Such as by Sandblasting or knurling.
`FIG. 11 is an enlarged side view partially in croSS Section
`of the cover wherein the elongate Shank has a circular
`shaped croSS Section and an alternate form of the change in
`contour is shown as an oval or elliptical shaped croSS Section
`for the tip.
`FIG. 12 is a view in cross section, taken along line 12-12
`of FIG. 11, showing the change in contour between the
`elongate Shank and tip.
`
`15
`
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`
`US RE38,996 E
`
`4
`FIG. 13 is an enlarged Side view partially in croSS Section
`of the cover showing the needle tip locked in the cover
`between the change in contour at the juncture of the enlarged
`tip and reduced diameter of the elongated Shank and the part
`which extends is a resilient metal Spring.
`FIG. 14 is a view in cross section, taken along line 14-14
`of FIG. 13, showing the metal spring retained on the tip
`COVC.
`FIG. 15 is a perspective view showing the tip cover and
`the metal Spring and how they fit one another forming a
`cover for a needle tip.
`FIG. 16 is a perspective view of the metal spring used in
`connection with the tip cover of FIGS. 13, 14 and 15.
`DETAILED DESCRIPTION OF THE
`INVENTION
`While this invention is satisfied by embodiments in many
`different forms, there is shown in the drawings and will
`herein be described in detail, a preferred embodiment and
`alternate embodiments of the invention, with the under
`Standing that the present disclosure is to be considered as
`exemplary of the principles of the invention and is not
`intended to limit the invention to any one of the embodi
`ments illustrated. The scope of the invention will be mea
`Sured by the appended claims and their equivalents.
`FIGS. 1 and 5 are side views of a catheter assembly 10
`with a needle tip cover 11 wherein a needle 12 is fully seated
`within a catheter 13 of the catheter assembly 10. The needle
`12 has an elongate shank 14 relative to an axis “A” thereof.
`The needle 12, preferably made of metal such as medical
`grade stainless Steel, has a tip 15 at its distal axial end 16
`terminating with a sharpened point 17. A cover 11 is
`coaxially associated with the elongate Shank 14 for sliding
`movement therealong toward the tip 15. The cover 11 is
`most preferably made of a polymer and includes a part
`which extends 18 being parallel to the axis “A” to reach
`beyond the sharpened point 17 when the cover 11 is posi
`tioned near the tip 15. FIGS. 4 and 8 show the sharpened
`point 17 surrounded within the part which extends 18 to
`protect against accidental injury of the user. Alternatively,
`and as will be explained in detail the cover 11 shown in
`FIGS. 9 through 16 includes a hooked end 19 on the part
`which extends 18.
`A lock 20 is operatively associated with the needle 12 and
`the cover 11 for cooperation therebetween to hold the cover
`11 in position over the tip in ways to be described.
`Specifically, the lock 20 is for securing the cover 11 to
`prevent the cover 11 from axial movement relative to the
`needle tip 15 after positioning the cover 11 near the tip 15.
`In particular, the lock 20 prevents the cover 11 from being
`removed from the elongate Shank 14.
`The cover 11 has a bearing 21 for circumscribing and
`coaxial sliding on the elongate Shank 14 and the part which
`extends 18 hangs cantilever from the bearing 21. Depending
`upon whether the cover 11, as shown in FIGS. 1 through 8
`or as shown in FIGS. 9 through 15, is considered the part
`which extends 18 may be proximal or distal, respectively.
`The lock 20 includes a change in contour 22 of the needle
`12 where the elongate shank 14 joins the tip 15 so that when
`the cover 11 interengages with the change in contour 22
`further distal movement of the cover 11 is prevented. The
`change of contour 22 may be a transition 23 between a
`reduced diameter elongate Shank 14 and an enlarged diam
`eter on the tip 15 as illustrated in FIG. 9. The change in
`contour 22 may alternately be a roughened Surface 24 on the
`needle 12 as depicted in FIG. 10. As shown in FIG. 10 the
`
`13
`
`

`

`S
`bearing 21 engages with the roughened Surface 24 causing
`the bearing 21 to lock therewith preventing further axial
`movement since the cover 11 is of a relatively soft polymer
`and the roughened Surface 24 is harder and has a coarse
`metallic Surface.
`In FIG. 12 the needle 12 is shown with a circular cross
`Section 25 So that the change of contour 22 leads to a
`non-circular cross section 26 near the tip 15. It should be
`appreciated that while a specific change in contour 22 is
`shown and described herein, any change in contour includ
`ing combinations of those disclosed should be considered
`equivalents. Specifically, FIGS. 11 and 12 include the cir
`cular croSS Section elongate Shank 14 and a oval or elliptical
`cross section for the tip 15 but just pinching the tip 15 to
`effect the change could be an alternative.
`In addition, FIGS. 2 through 4 and 6 through 8 include yet
`another alternate of the change of contour 22. A notch 28, cut
`into the needle 12, provides a latch face 29 and a pawl 30 on
`the cover which engages with the notch 28 at the latch face
`29 and resists axial movement of the cover 11 proximally
`along the needle 12. The pawl 30 extends proximally from
`the bearing 21 and is resiliently Supported thereon and is
`urged toward the elongate Shank 14 So that the alignment of
`the pawl 30 with the notch 28 will cause interengagement
`thereby preventing further movement of the cover 11. The
`particular arrangements shown in FIGS. 2 through 4 and 6
`through 8 have a pair 31 of opposed pawls 30 to seat in the
`notch 28 of the needle 12. The needle 12 may have a bore
`32 therethrough along the axis “A” thereof if that is desired
`for the particular application of the catheter assembly 10.
`Alternatively, the part which extends 18 may be primarily
`distal and the bearing 21 can be proximal, as shown in FIGS.
`9 through 11. To prevent the proximal axial movement of the
`cover 11 away from the tip 15 on the elongate shank 14 after
`the cover 11 is positioned near the tip 15, the bearing 21 fits
`about the elongate Shank 14 allowing sliding engagement
`and limiting distal axial movement of the cover 11 for
`preventing removal of the cover 11 from the elongate Shank
`14. The bearing 21 has an inside diameter to fit about the
`elongate Shank 14 for controlling Sliding axial movement
`therealong toward the change in contour 22.
`The needle tip cover 11 of FIGS. 9 through 11 is a molded
`piece Such as a highly resilient polymer material in order to
`provide the resilience necessary to protect the needle tip 15
`as shown. The tip cover 11, however, should withstand high
`temperatures, Sterilization and long periods wherein the part
`which extends 18 is held with its hooked end 19 in a ready
`to close position. In FIGS. 9 through 11 and 13 the part
`which extends 18 is shown with the hooked end 19 protect
`ing the sharpened point 17.
`To avoid problems of permanent set or distortion of a
`polymeric cover 11 due to maintenance in that ready to close
`position of the part which extends 18, an alternate approach
`is disclosed in FIGS. 13 through 16 wherein the resilience is
`provided by making the part which extends 18 of metal such
`as high Strength medical grade Stainless Spring Steel. The
`exact configuration of the metal part which extends 18 is
`shown in FIG. 15 and includes the hooked end 19 and a
`retainer portion33. The part which extends 18 made of metal
`is, as in the all polymer cover 11 of FIGS. 9 through 11, a
`cantilever with a hooked end 19 and the retainer portion 33
`has a pair of extended wrap around members 34 connected
`transversely to the end thereof opposite the hooked end 19.
`Members 34 cooperate with the molded polymeric tip cover
`11 shown in FIG. 15 wherein the members 34 are spread
`apart, placed about and engaged with a Square Section 35 of
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`the molded tip cover 11 shown in FIG. 14. An additional
`View which illustrates the relationship is the partial croSS
`section shown in FIG. 13. The needle tip cover 11 design is
`not to be limited to the two arrangements shown, these are
`merely for purposes of illustration and are not to be con
`sidered limiting.
`The catheter assembly 10 is of an over the needle type
`wherein a catheter 13 is inserted into a vessel by a single
`hand technique as described in U.S. Pat. No. 3,714,945. The
`catheter assembly 10, shown in FIGS. 2 through 4, 6 through
`11, 13 and 15, has the cover 11 engaged about the outside of
`a catheter adapter 36 that is connected in fluid tight com
`munication with the catheter 13. In FIGS. 2 through 4, 6
`through 11, 13 and 15, the tip cover 11 is distally cupped for
`engagement with the proximal end of the catheter adapter
`36. More particularly, a proximal external Surface 37 of the
`catheter adapter 36 is a preSS fit with the distally cupped
`cover 11 in all but the arrangement of FIGS. 1 through 4
`wherein the catheter adapter 36 has a luer thread 38 on its
`external proximal Surface. The cover 11 has a distally
`extending internally threaded collar 39 located and shaped to
`conjugate in a threaded connection with luer thread 38. The
`preSS fit engagement of the cover 11 and the adapter 36
`shown in FIGS. 6 through 8, 9 through 11 and 13 is such that
`the adapter 36 will retain and pull the cover 11 distally along
`the elongate Shank 14 toward the change in contour 22 as the
`adapter 36 is separated from a needle hub 40. FIGS. 3 and
`7 illustrate the separation of the hub 40 and the cover 11 and
`it should be appreciated that the various arrangements
`shown and described all Separate in the same way whether
`the threaded engagement or the friction engagement is used.
`The separation of the adapter 36 and the hub 3840 causes
`the cover 11 to slide distally on the elongate shank 14 of the
`needle 12 toward the change in contour 22.
`There is a lug 41 on the proximal end of the cover 11 as
`shown in FIGS. 9 through 11 and 13, the lug 41 is arranged
`to engage with a groove 42 in the catheter adapter 36 Such
`that the relative rotary relationship therebetween is main
`tained when the tip cover 11 is assembled with the catheter
`adapter 36. It will also be noted that the cover 11 has its
`cupped shape designed to close the proximal open of the
`catheter adapter 36 thereby retaining any blood or bodily
`fluids obtained during flashback.
`A method of assembly of the needle hub 40 and the cover
`11 to an end 43 opposite the tip 15 of the needle 12 and the
`needle 12 having the change in contour 22 and the cover 11
`having the bearing 21 for circumscribing and coaxial sliding
`on the elongate Shank 14, includes the following Steps:
`placing the cover 11 coaxially about the elongate Shank 14
`with the bearing 21 thereof axially slidable therealong,
`and
`securing the hub 40 to the end 43 in FIGS. 3, 4, 7 and 8
`of the elongate shank 14 over which the bearing 21 was
`placed upon the needle 12 thereby capturing the cover
`11 between the change in contour 22 and the hub 40.
`A method of inserting the catheter assembly 10 by an over
`the needle technique requires the needle 12 and the cover 11
`carried about the needle 12 on the elongate shank 14 thereof
`for movement therealong from the hub 3840 to the tip 15,
`includes the following Steps:
`applying pressure to the catheter assembly 10 to penetrate
`the skin of an animal with the tip 15 of the needle 12
`and carry a distal part 44 of the coaxially positioned
`catheter 13 into the skin;
`inserting the catheter assembly 10 further through the skin
`of the animal by holding the hub 38 40 thereof
`between a finger and the thumb of the user, and
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`moving the cover 11 axially along the needle 12 from the
`hub 40 to the tip 15 with another finger while with
`drawing the hub 40 and needle 12 from the inserted
`catheter 13 and adapter 36 with the other finger and
`thumb to lock the cover 11 over the tip 15.
`We claim:
`1. A catheter introducer Set, comprising:
`a catheter adapter having a distal end and a proximal end
`with an external Surface;
`a cannula Secured to the distal end of the catheter adapter;
`a needle hub having a proximal end and an open distal
`end;
`a needle having a Sharp distal end and a proximal end
`Secured to the needle hub, the needle being coaxially
`disposed within the open distal end of the needle hub
`and the cannula and having a change of contour the
`realong; and
`a needle cover coaxially disposed about the needle and
`disposed between the needle hub and the proximal end
`of the catheter adapter and having a distal end engaging
`the external Surface of the proximal end of the catheter
`adapter to maintain the needle cover in engagement
`with the catheter adapter and a proximal end disposed
`within the open distal end of the needle hub and
`wherein the proximal end of the needle cover engages
`the change in contour along the needle to obstruct the
`sharp distal end of the needle when the sharp distal end
`of the needle is withdrawn into the needle cover.
`2. The catheter introducer set of claim 1 wherein the
`change in contour along the needle is a notch.
`3. The catheter introducer set of claim 1 wherein the
`change in contour along the needle is a non-circular croSS
`Section.
`4. The catheter introducer set of claim 1 wherein the
`change in contour along the needle is a transition between a
`reduced diameter and an increased diameter.
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`5. The catheter introducer set of claim 1 wherein the
`change in contour in the needle is a roughened Surface on the
`needle.
`6. A catheter introducer Set, comprising:
`a catheter adapter having a distal end and a proximal end
`with an external Surface,
`a cannula Secured to the distal end of the catheter
`adapter,
`a needle hub having a proximal end and an Open distal
`end,
`a needle having a Sharp distal end and a proximal end
`Secured to the needle hub, the needle being disposed
`within the open distal end of the needle hub and having
`a change of contour therealong, and
`a needle cover disposed between the needle hub and the
`catheter adapter and engaging the external Surface of
`the catheter adapter to maintain the needle cover in
`engagement with the catheter adapter and having a
`proximal end disposed within the open distal and of the
`needle hub and wherein the needle cover engages the
`change in contour along the needle such that the needle
`cover obstructs the Sharp distal end of the needle when
`the Sharp distal end of the needle is withdrawn into the
`needle cover.
`7. The catheter introducer Set of claim 6 wherein the
`change in contour along the needle is a notch.
`8. The catheter introducer Set of claim 6 wherein the
`change in contour along the needle is a non-circular croSS
`Section.
`9. The catheter introducer Set of claim 6 wherein the
`change in contour along the needle is a transition between
`a reduced diameter and an increased diameter:
`10. The catheter introducer set of claim 6 wherein the
`change in contour in the needle is a roughened Surface On
`the needle.
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