[19]
`United States Patent
`5,558,651
`
`Crawford et a].
`[45] Date of Patent:
`Sep. 24, 1996
`
`[11]
`
`Patent Number:
`
`lllllllllllllll|||||||l|l||||l|l||||lllllllllllllllllllll||||||l|||||||||||
`U3005558651A
`
`[54] APPARATUS AND METHOD FOR A NEEDLE
`TIP COVER
`
`[75]
`
`‘
`1
`Inventors: Mark A. Crawford, Sandy; Timothy
`g'f2:32:6(gfalglflo3511:2501" both
`y’
`.
`.
`.
`[73] Ass1gnee: Becton Dleklnson and Company,
`Fraflkhfl Lakesv N-J-
`
`[2]] Appl. No.: 364,071
`[22]
`Filed:
`Dec. 27, 1994
`
`Related U.S. Application Data
`
`[63] Continuation of Ser, No. 114,988, Aug. 12, 1993, aban-
`doned, which is acontinuation of Ser, No. 512,284,Apr. 20,
`1990, abandoned.
`
`Int Cl"
`[51]
`
`[52] U.S. Cl.
`58
`F' 1d
`f S
`le
`
`A61M 5/00
`604/263; 604/110; 604/164;
`GOA/6154601849169:
`h
`831:04/1621661671681 92 197’ 198,
`’
`’
`’
`263 5’3. 128/919
`’
`’
`
`.
`References Cited
`U.S. PATENT DOCUMENTS
`
`
`0
`
`[
`
`1
`
`[56]
`
`323;: $101? 1""""
`602313;);
`22343133?
`
`9/1986 Luca]: we
`604/168
`4,610,671
`
`8/1988 Luther cial
`604/164
`4:762’516
`..........
`604/165
`7/1939 Sim,
`4,846,805
`
`7/1989 Wanderer 01 a1.
`_, 6114/53
`4,850,961
`
`604/198
`7/1989 Bayless .
`4,850,977
`
`3/1990 Dolan
`604/198
`4,911,694
`
`-----
`5/1990 K111“
`604/253
`4-9292“
`leCllX
`,
`,
`
`31333 rag? Cl 3]
`23:11:12:
`23222371
`9/1990 Corey
`4,955,866
`604/192
`4,964,854 10/1990 Luther
`604/166
`
`
`11/1990 Bobrove
`.. 604/198
`4,973,317
`
`
`2/1991 Byrne et al.
`.. 604/198
`4,990,141
`2/1991 Dombrowski
`604/164
`4,994,041
`
`5/1991 Heifetz
`604/198
`5,015,242
`
`1mon
`7
`,
`3:33:
`g’gglfigg
`JS9hnson -
`gfigzg
`5,053,017 10/1991 Charnucl
`604/192
`
`5,059,180 10/1991 McLees ..
`604/110
`
`5,059,184 10/1991 Dyke ..
`604/198
`8/1992 McLees ..
`5,135,504
`604/164
`
`8/1992 Kaufman
`5,135,505
`604/165
`.....
`5,169,391
`12/1992 Vogel
`604/177
`
`
`1/1993 McCormick etal
`5,176,655
`604/198
`2/1993 McLees .................
`.. 604/164
`5,183,468
`
`.. 604/164
`7/1994 Sircom et a].
`.
`5,328,482
`5,458,658
`10/1995 Sircom .......
`604/192
`
`
`5,487,733
`1/1996 Caizza et al.
`604/110
`3/1996 Graves et all
`.
`5,496,274
`604/86
`
`.
`.
`Prlr'nary ExamineriRandall 1'“ Green
`Asszstam Examiner—V. Alexander
`Attorney, Agent, or Firm—Eric M. Lee, Esq.
`[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 therealong
`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 and
`holds the cover to prevent axially movement relative to the
`needle tip after positioning the cover near the tip. The needle
`and cover 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 the needle and
`hub. The catheter has a bore therethrough sized to surround
`the elongate shank for movement therewith during insertion
`and therealong during placement. A retaining means 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
`Edam“ an” placcmcm'
`11 Claims, 9 Drawing Sheets
`
`11
`
`41
`
`36
`
`
`
`
`V ' ”A”, 14",
`
`
`€717%%4E.ié,
` 37
`
`1
`
`B. Braun 2006
`
`1
`
`B. Braun 2006
`
`

`

`U.S. Patent
`
`Sep. 24, 1996
`
`Sheet 1 of 9
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`5,558,651
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`Sep. 24, 1996
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`Sep. 24, 1996
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`Sheet 7 of 9
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`US. Patent
`
`Sep. 24, 1996
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`Sheet 8 of 9
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`5,558,651
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`

`US. Patent
`
`Sep. 24, 1996
`
`Sheet 9 of 9
`
`5,558,651
`
`
`
`10
`
`10
`
`

`

`5,558,651
`
`1
`APPARATUS AND LIETHOD FOR A NEEDLE
`TIP COVER
`
`This application is a continuation of application Ser. No.
`08/114,988, filed Aug. 12, 1993, now abandoned which is a
`continuation of application Ser. No. 07/512,284, filed Apr.
`20, 1990, now abandoned.
`1. 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 pcnetration of the used needle tip into an animal.
`2. Background
`transmission of AIDS,
`With concern about infection,
`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 thcrcin 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. 4,846,809 has a needle tip protector with a
`collapsible sleeve dispOscd about the shank of the needle
`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 acomprcssiblc device extending over
`the needle shank. Rubber septa are provided at the opposite
`ends of the compressible device so as to surround the needle.
`
`5
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`
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`
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`
`2
`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. A safety 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 thercalong 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 elf 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
`intercngages with the change in contour it becomes locked
`relative to the needle preventing further axial movement.
`The hearing 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 aftcr 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 thercthrough sized to surround
`the elongate shank of the needle for movement therewith
`during insertion and therealong during placement. A retainr
`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
`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
`
`11
`
`11
`
`

`

`5,558,651
`
`3
`cover coaxially about the elongate shank with the bearing
`thereof axially slidable therealong toward the tip and secur-
`ing the hub to the end of the elongate shank over which the
`hearing 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, insem‘ng 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 altemate 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.
`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
`
`- 4
`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
`cover.
`
`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 tipvcover of FIGS. 13, 14 and 15.
`DETAILED DESCRIPTION OF THE DRAWINGS
`
`While this invention is satisfied by embodiments in many
`ditferent 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 appendedclaims 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. Specifi—
`cally, 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
`bearing 21 engages with the roughened surface 24 causing
`the beating 21 to lock therewith preventing further axial
`movement since the cover 11 is of a relatively soft polymer
`
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`5,558,651
`
`5
`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 l4 and a oval or elliptical
`cross section for the tip 15 but just pinching the tip 15 to
`ell’cct 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 intercngagement
`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 thercthrough 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
`covcr 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 lit about the
`elongate shank 14 for controlling sliding axial movement
`therealeng 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 protecta
`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 portion 33. 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
`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
`
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`6
`not to be limited to the two arrangements shown, these are
`merely for purposes of illustration and are not to be con-
`sidcrcd 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 US. 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 tit 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 40 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 therealeng,
`and
`securing the hub 40 to the end 43 in FIGS. 3, 4, 7 and 8 of
`the elongate shank 14 over which the hearing 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 38 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 thereof between a finger
`and the thumb of the user, and
`moving the cover 11 axially along the needle 12 from the
`hub 40 to the tip 15 with another finger while withdrawing
`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.
`
`13
`
`13
`
`

`

`5,558,651
`
`7
`
`What is claimed is:
`1. A catheter introducer set, comprising:
`a catheter adapter having a distal end and a proximal end;
`a cannula secured to the distal end of the catheter adapter;
`a needle hub;
`a needle having a sharp distal end and a proximal end
`secured to the needle hub,
`the needle coaxially dis-
`posed initially within the cannula;
`a needle cover coaxially disposed about the needle and
`located distal of the needle hub and proximal of the
`catheter adapter;
`a resilient, self-actuating needle tip guardroperably con—
`nected to the needle cover, the needle tip guard having
`an arm and a single transverse wall extending at an
`angle from the arm to obstruct the sharp distal end of
`the needle when the sharp distal end of the needle is
`withdrawn into the needle cover; and
`a means for limiting proximal movement of the needle
`with respect to the needle cover when the needle is
`withdrawn into the needle cover,
`2. The catheter introducer set of claim 1 wherein the
`means for limiting proximal movement of the needle is a
`change in contour along the needle that engages the needle
`cover.
`3. The catheter introducer set of claim 2 wherein the
`change in contour along the needle is a notch.
`4. The catheter introducer set of claim 2 wherein the
`change in contour along the needle is a non—circular cross—
`section
`5. The catheter introducer set of claim 2 wherein the
`change in contour along the needle is a transition between a
`reduced diameter and an increased diameter.
`6. The catheter introducer set of claim 2 wherein the
`change in contour in the needle is a roughened surface on the
`needle.
`‘
`7. A catheter and introducer needle assembly, of the type
`including a needle and needle cover, for limiting distal
`movement of the needle with respect to the needle cover
`after the needle has been withdrawn from the catheter,
`comprising:
`_
`a needle hub and a needle having a shaft, a tip and a
`proximal end secured to the needle hub:
`
`10
`
`IS
`
`20
`
`25
`
`30
`
`35
`
`4O
`
`8
`a catheter assembly having a catheter adapter and a
`cannula disposed about the needle;
`a cover for shielding the needle, the cover being located
`distal of the needle hub and proximal of the catheter
`adapter, wherein the needle is slidable along the cover
`from a first position in which the needle tip is distal of
`the cover to a second position in which the needle tip
`is shielded by the cover; and
`a resilient, self—actuating needle tip guard operably con-
`nected to the cover and having an arm and a single
`transverse wall extending at an angle from the arm
`wherein when the needle is moved from the first
`. position into the second position, the wall obstructs the
`needle tip to prevent the needle from sliding into the
`first position.
`8. The catheter and introducer needle assembly of claim
`7 wherein the wall automatically obstructs the needle tip
`when the needle is moved from the first position to the
`second position.
`9. The catheter and introducer needle assembly of claim
`8 wherein the wall abuts the needle shaft in the first position,
`10. The catheter and introducer needle assembly of claim
`7 wherein the cover is made of a polymer and the needle tip
`guard is a metal spring with the single transverse wall
`substantially perpendicular to the shaft of the needle to
`obstruct the needle tip when the needle is moved from the
`first position into the second position.
`11. A catheter for use with an introducer needle for
`insertion of the catheter into a patient, comprising:
`a catheter adapter with a proximal end and a distal end;
`a cannula secured, to the distal end of the catheter adapter;
`3 cover removably connected to the proximal end of the
`catheter adapter; and
`a resilient, self-actuating guard connected to the cover, the
`guard having an arm and a single transverse wall
`extending at an angle from the arm, the single trans—
`verse wall located proximal of the proximal end of the
`catheter adapter.
`
`14
`
`14
`
`