U.S. patent application number 09/767236 was filed with the patent office on 2001-06-07 for syringe tip cap.
Invention is credited to Imbert, Claude.
Application Number | 20010003150 09/767236 |
Document ID | / |
Family ID | 23397466 |
Filed Date | 2001-06-07 |
United States Patent
Application |
20010003150 |
Kind Code |
A1 |
Imbert, Claude |
June 7, 2001 |
Syringe tip cap
Abstract
A tip cap is provided for positive sealing engagement with the
tip of a syringe barrel. The tip cap includes an inner cap formed
from an elastomeric material dimensioned for sealing engagement
with the tip of the syringe barrel. The tip cap further includes an
outer cap engaged with the inner cap to limit or prevent both axial
movement and rotational movement therebetween. The outer cap
includes an array of threads for threaded engagement with a luer
collar. The luer collar may be a separate component mountable to a
syringe barrel or an integral part of the syringe barrel.
Inventors: |
Imbert, Claude; (La Tronche,
FR) |
Correspondence
Address: |
BECTON, DICKINSON AND COMPANY
1 BECTON DRIVE
FRANKLIN LAKES
NJ
07417-1880
US
|
Family ID: |
23397466 |
Appl. No.: |
09/767236 |
Filed: |
January 22, 2001 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09767236 |
Jan 22, 2001 |
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09382263 |
Aug 24, 1999 |
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6190364 |
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Current U.S.
Class: |
604/256 ;
604/111 |
Current CPC
Class: |
A61M 5/3134 20130101;
A61M 2005/3104 20130101; A61M 39/1011 20130101; A61M 5/5086
20130101; A61M 5/344 20130101; A61M 5/50 20130101 |
Class at
Publication: |
604/256 ;
604/111 |
International
Class: |
A61M 005/00 |
Claims
What is claimed is:
1. A tip cap assembly for a hypodermic syringe barrel having a
distally projecting tip with a fluid passageway extending
therethrough, said tip cap assembly comprising: a collar securely
engageable around said tip; an inner cap sealingly engageable with
said tip; an outer cap securely disposed around said inner cap and
releasably engaged with said collar; and said assembly being
configured so that said inner cap sealingly engages said tip when
said collar is securely engaged around said tip, and said inner cap
is disengageable from said tip in response to disengagement of said
outer cap from said collar.
2. The tip cap assembly of claim 1, wherein said collar includes
needle mounting means for releasably engaging a needle assembly,
said outer cap being releasably engageable with said needle
mounting means of said collar.
3. The tip cap assembly of claim 2, wherein the needle mounting
means of said collar comprises an array of threads, said outer cap
comprising thread means for releasable threaded engagement with
said threads of said collar.
4. The tip cap assembly of claim 1, wherein said inner and outer
caps includes means for preventing relative axial movement
therebetween.
5. The tip cap assembly of claim 1, wherein said inner cap is
formed from an elastomeric material, and wherein said outer cap is
formed from a rigid plastic materia.
6. The tip cap assembly of claim 1, further comprising tamper
indicator means extending between said collar and said outer cap
for indicating separation of said outer cap from said collar.
7. The tip cap of claim 1, wherein said inner cap, a cylindrically
shaped side wall defining a cavity to accept said tip and a vent
aperture in said side wall for preventing generation of a vacuum
during removal of said tip cap assembly from said tip.
8. A tip cap for a hypodermic syringe barrel having a distally
projecting tip with a fluid passage extending therethrough and a
luer collar concentrically surrounding said tip, and luer collar
including an array of internal threads for threadingly engaging a
needle hub, said tip cap comprising: a resilient inner cap and
having opposed proximal and distal ends, said proximal end defining
a tip engaging portion for sealingly engaging said tip of said
syringe barrel; and a rigid outer cap securely engaged around at
least portions of said inner cap, said outer cap having an array of
external threads threadably engageable with the threads of said
luer collar such that said outer cap securely and releasably
retains said inner cap in sealing engagement with said tip.
9. The tip cap of claim 8, wherein said inner and outer cap
includes means for limiting relative rotational movement between
said inner and outer caps.
10. The tip cap of claim 9, wherein the means for limiting relative
rotational movement comprises interdigitated axially aligned
anti-rotation ribs on said inner and outer caps respectively.
11. The tip cap assembly of claim 8, wherein said inner and outer
caps further include means for limiting relative axial movement
therebetween.
12. The tip cap assembly of claim 8, wherein one of said inner and
outer caps includes an annular rib, and wherein the other of said
inner and outer caps comprises an annular groove engaged with said
annular rib for preventing relative axial movement between said
inner and outer caps.
13. The tip cap assembly of claim 8, wherein said proximal end of
said inner cap includes a cylindrically shaped side wall defining a
cavity for accepting said tip and a vent conduit in said side wall
for minimizing suction during removal of said inner cap from said
tip.
14. A tip cap assembly for a glass syringe barrel having a distally
projecting tip with a fluid passage extending therethrough, said
tip cap assembly comprising: a luer collar formed from a
thermoplastic material and having means for securely locking said
luer collar to said tip, said luer collar having an array of
internal threads in spaced concentric relationship around said tip;
an resilient inner cap having opposed proximal and distal ends,
said proximal end being configured for sealingly engaging said tip,
said proximal end having at least one axially extending projection,
porions of said inner cap intermediate said proximal and distal
ends defining a locking surface; and a rigid outer cap disposed in
generally surrounding relationship to said inner cap, said outer
cap including at least one axially extending projection engaged
with said rib of said inner cap for controlling relative rotation
between said inner and outer caps, said outer cap further
comprising at least one surface engaged with said locking surface
of said inner cap for preventing relative axial movement
therebetween, and said outer cap comprising an array of external
threads threadedly engaging said threads of said luer collar, said
threads being disposed for urging said inner cap into tight sealing
engagement with said tip in response to tightening of said outer
cap to said luer collar whereby threaded disengagement of said
outer cap from said luer collar disengages said inner cap from said
tip.
15. The tip cap assembly of claim 14, further comprising vent means
in said inner cap for minimizing vacuum during separation of said
inner cap from said tip.
16. The tip cap assembly of claim 14, further comprising a
frangible tamper evident seal extending between and connecting said
outer cap and said luer collar.
Description
[0001] 1. Field of the Invention
[0002] The subject invention relates to a tip cap for securely
sealing the tip of a hypodermic syringe barrel.
[0003] 2. Description of the Prior Art
[0004] The prior art hypodermic syringe includes a barrel having an
open proximal end and an opposed distal. A cylindrical wall extends
between the ends and defines a fluid-receiving chamber. An elongate
tip projects from the distal end of the prior art syringe barrel
and includes a narrow passage which communicates with the
fluid-receiving chamber of the barrel. A plunger may be inserted
into the open proximal end of the prior art syringe barrel for
sliding fluid-tight engagement with the cylindrical chamber wall.
Sliding movement of the plunger in a distal direction urges fluid
in the chamber through the passage in the tip. Conversely, sliding
movement of the plunger in a proximal direction draws fluid through
the passage in the tip and into the chamber of the prior art
syringe barrel.
[0005] Prior art syringe barrels typically are made of plastic or
glass. Glass exhibits lower gas transmissivity than plastic. Thus,
glass syringe barrels are used for medications that are
particularly susceptible to interaction with ambient gases. Glass
syringe barrels also are preferably used for medications that are
pre-filled into the syringe barrel and stored for a considerable
period of time prior to use.
[0006] The prior art hypodermic syringe further includes a needle
assembly with a needle cannula having a proximal end, a pointed
distal end and a lumen extending axially therethrough. The prior
art needle assembly also includes a hub which is engageable with
mounting means on the syringe barrel for selectively placing the
lumen of the needle cannula in fluid communication with the passage
through the tip of the syringe barrel. One prior art mounting means
includes a luer collar disposed in spaced concentric relationship
around the tip of the syringe barrel. The luer collar includes an
array of threads for threaded engagement with corresponding
structure on the hub of the needle. For example, the luer collar
may include an array of internal threads which are engageable with
projections extending outwardly from the hub of the needle cannula.
Prior art syringe barrels formed from plastic may have the luer
collar unitarily molded therewith. However, glass syringe barrels
cannot be formed with a unitary luer collar. Thus, glass syringe
barrels and some plastic syringe barrels may have a separately
formed luer collar securely mounted to the tip of the syringe
barrel. The luer collar may rely upon a slip fit interengagement, a
snap fit or other such secure mounting engagement around the tip of
the syringe barrel.
[0007] Medications that are pre-filled into a syringe barrel must
be sealed to prevent contamination or loss of the medication. Seals
also prevent health care workers from being needlessly exposed to
medications. The prior art has included stoppers mounted over the
tip at the distal end of the syringe barrel to prevent leakage and
to avoid contamination of the medication. Prior art tip caps have
been formed from elastomeric material frictionally and/or
resiliently retained in engagement with the tip of the prior art
syringe barrel. The prior art tip cap may be removed from the
syringe tip shortly prior to usage of the hypodermic syringe. The
hub of the needle assembly may then be securely engaged with the
luer collar or other mounting means adjacent the exposed tip of the
syringe barrel. For example, the needle hub may be threadedly
engaged within the luer collar such that the lumen of the prior art
needle cannula communicates with the exposed tip of the prior art
syringe barrel.
[0008] Prior art elastomeric tip caps on the ends of pre-loaded
prior art syringe barrels generally perform well. However, the
resiliently and/or frictionally engaged prior art tip cap may be
accidentally disengaged from the prior art syringe barrel in
response to inadvertent forces imposed thereon or due to
dimensional changes or instability of the elastomeric seal.
Additionally, the vacuum created as the prior art elastomeric tip
cap is removed from the tip can lead to the loss of medication and
unnecessary personal contact with medication that the tip cap is
intended to avoid. Additionally, the prior art elastomeric tip cap
provides no evidence of tampering or misuse of a pre-loaded
hypodermic syringe.
SUMMARY OF THE INVENTION
[0009] The subject invention is directed to an effective tip cap
assembly for a hypodermic syringe, and to a hypodermic syringe
assembly having a more effectively sealed tip. A hypodermic syringe
in accordance with the subject invention includes a barrel having a
proximal end, a distal end and a chamber wall extending
therebetween. The chamber wall defines a fluid-receiving chamber
which may be pre-loaded with a selected dose of medication. The
distal end of the syringe barrel includes a tip having a passage
extending therethrough. The distal end may further include needle
mounting means for selective engagement with mounting structure on
a needle cannula. The mounting means may comprise a luer collar
that is either unitarily formed with the syringe barrel or that is
securely mounted to the syringe barrel in proximity to the tip.
[0010] The tip cap of the subject invention includes an elastomeric
inner cap frictionally and/or resiliently engagement with portions
of the tip for sealing the passage through the tip. The tip cap
assembly further includes a substantially rigid outer cap
engageable with the needle mounting means of the syringe barrel and
protectively enclosing the inner cap. For example, the outer cap
may include projections or threads engageable with threads of a
luer collar integral with or mounted to the syringe barrel. The
outer cap may be frictionally, resiliently and/or mechanically
engaged with the inner cap. Thus, disengagement of the outer cap
from the needle mounting means of the syringe barrel may
simultaneously disengage the inner cap from the tip of the syringe
barrel.
[0011] The inner cap and the outer cap may be separately
manufactured and assembled to one another after manufacture.
Alternatively, the inner cap and the outer cap may be integral with
one another. In this regard, the inner or outer cap may define an
insert in a mold cavity employing insert molding technology.
Alternatively, the inner and outer caps may be formed by
coinjection of appropriate materials into the mold cavity of an
injection molding apparatus. Still further, the inner and outer
caps may be formed respectively by sequential injection molding
techniques using a single mold cavity.
[0012] The inner and outer caps may be assembled or molded together
and subsequently attached to a needle mounting structure unitarily
formed at the distal end of a plastic syringe barrel.
Alternatively, the inner and outer caps may be assembled or formed
together and then engaged with a plastic mounting collar for a
glass syringe barrel. The assembled inner and outer caps and the
mounting collar engaged therewith may then be securely mounted to
the tip of a syringe barrel.
[0013] The subject invention may further include a tamper evident
seal for connecting the outer cap to the needle mounting means of
the syringe barrel. The tamper evident seal may comprise a
severable label extending across the interface between the outer
cap and the collar. Alternatively, a frangible spot weld may
connect the outer cap to the luer collar or other such needle
mounting means.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is an exploded perspective view of a syringe barrel
and a tip cap assembly in accordance with the subject
invention.
[0015] FIG. 2 is an exploded side elevational view of a syringe
barrel and the tip cap assembly of FIG. 1.
[0016] FIG. 3 is a side elevational view of the tip cap assembly
and the syringe barrel of FIGS. 1 and 2 in their fully assembled
condition.
[0017] FIG. 4 is a cross-sectional view taken along line 4-4 in
FIG. 3.
[0018] FIG. 5 is a cross-sectional view taken along the
longitudinal axis of the inner cap of the tip cap assembly.
[0019] FIG. 6 is a side elevational view, partly in section of the
outer cap of the tip cap assembly.
[0020] FIG. 7 is a cross-sectional view taken along the
longitudinal axis of the luer collar of the tip cap assembly.
[0021] FIG. 8 is a cross-sectional view similar to FIG. 4 but
showing a syringe barrel having a unitary needle mounting
collar.
[0022] FIG. 9 is a partial side elevational view of an alternative
syringe barrel of the subject invention.
[0023] FIG. 10 is a partial side elevational view of another
alternative syringe barrel of the subject invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0024] Adverting to FIGS. 1-7, a hypodermic syringe in accordance
with the subject invention is identified generally by the numeral
10. With reference to FIG. 1, hypodermic syringe 10 includes a
syringe barrel 12 unitarily formed from a transparent material,
such as glass or plastic. Syringe barrel 12 includes a proximal end
14, a distal end 16 and a cylindrical wall 18 extending
therebetween. Cylindrical wall 18 defines a fluid-receiving chamber
20 in barrel 12. The distal end of syringe barrel 12 includes a tip
22 having a passageway 24 extending therethrough and communicating
with the chamber 20. A plunger rod assembly 26 extends into
proximal end 14 of syringe barrel 12, and includes a stopper 28,
which is in sliding fluid-tight engagement with cylindrical wall 18
of chamber 20.
[0025] Syringe barrel 12 is used with a needle assembly 30 which
includes a needle cannula 32 having a proximal end 34, a distal end
36 and a lumen 38 extending therebetween. Distal end 36 of the
needle hub preferably includes sharpened tip 37. A mounting hub 40
is securely affixed to proximal end 434 of needle cannula 32 and
includes projections 42 extending therefrom for threaded engagement
with a luer collar.
[0026] As noted above, syringe barrel 12 may be formed from glass,
and hence does not have an integral luer collar for engaging
mounting hub 40 of needle assembly 30. Rather, a thermoplastic luer
collar 44 is provided for selective engagement over tip 22 of
syringe barrel 30. More particularly, luer collar 44 is a generally
hollow cylindrical structure having opposed proximal and distal
ends 46 and 48. Proximal end 46 of luer collar 44 includes an array
of inwardly directed projections 50 for frictionally engaging tip
22 of syringe barrel 12 and retaining luer collar 44 thereon.
Distal end 48 of luer collar 44 includes an array of internal
threads 52 dimensioned and pitched for threaded engagement by
projections 42 of mounting hub 40 on needle assembly 30. Thus,
proximal end 46 of luer collar 44 can be urged in a proximal
direction over tip 22 of syringe barrel 12. Mounting projections 50
will deflect slightly and frictionally engage tip 22 to resist
separation of luer collar 44 from syringe barrel 12. Mounting hub
40 may then be threadedly engaged with luer collar 44 to place
lumen 38 of needle cannula 32 in communication with passage 24
through tip 22, and further in communication with chamber 20 of
syringe barrel 12.
[0027] As noted above, needle assembly 30 may be maintained
separate from syringe barrel 12, and may be mounted to syringe
barrel 12 a short time prior to usage of hypodermic syringe 10.
Syringe barrel 12 may be pre-filled with medication, and stored in
its pre-filled condition prior to mounting needle assembly 30
thereto. To prevent contamination or leakage of medication stored
in syringe barrel 12, a tip cap assembly is provided.
[0028] A tip cap assembly in accordance with the subject invention
is identified generally by the numeral 54 in FIGS. 1-4, and
includes an inner cap 56 and an outer cap 58. Inner cap 56, as
shown most clearly in FIG. 5 is unitarily molded from an
elastomeric material and includes opposed proximal and distal ends
60 and 62 respectively. Portions of inner cap 56 extending
proximally from distal end 62 define a tip-engaging portion 64
having a cavity 66 dimensioned to tightly resilient engage tip 22
of syringe barrel 12. This preferred embodiment preferably includes
a stopper 67 projecting proximally from portions of tip engaging
portion 64 and defines the inner-most end of cavity 66. Stopper 67
is disposed and dimensioned to pass into passage 24 of tip 22 for
further enhancing the sealing ability of inner cap 56. Inner cap 56
preferably includes a vent aperture 69 extending through tip
engaging portion 64 for reducing the vacuum created as inner cap 56
is being removed from tip 22. Vent aperture 69 is disposed to be
blocked by tip 22 when the inner cap 56 is fully seated. However,
vent aperture 69 will permit gas communication to cavity 66 as
inner cap 56 is being removed to minimize vacuum as inner cap 56 is
being removed from tip 22.
[0029] Portions of inner cap 56 extending proximally from distal
end 62 define a plurality of axially extending anti-rotation ribs
68 which are spaced at approximately 45.degree. from one another
about the outer circumference of inner cap 56. Anti-rotation ribs
68 define an outer diameter "a" as illustrated in FIG. 5.
[0030] Inner cap 56 further includes an annular undercut 70
extending around the outer periphery thereof at a location spaced
distance "b" from distal end 62 of inner cap 56. Undercut 70
defines an outside diameter "c".
[0031] Outer cap 58, as illustrated most clearly in FIG. 6, is a
generally tubular member unitarily formed from a rigid
thermoplastic material. Outer cap 58 includes opposed proximal and
distal ends 72 and 74 respectively and a stepped aperture 76
extending entirely therethrough. Portions of aperture 76 adjacent
distal end 74 define a major inside diameter "d" which is
approximately equal to the outer diameter "a" defined by
anti-rotation ribs 68 adjacent distal end 62 of inner cap 56.
However, portions of aperture 76 adjacent distal end 74 of outer
cap 58 are characterized by inwardly extending anti-rotation ribs
78. Distal ends of ribs 78 are generally pointed for urging
anti-rotation ribs 68 of inner cap 56 into positions intermediate
adjacent ribs 78 during assembly of inner and outer caps 56 and
58.
[0032] Stepped aperture 76 further includes an inwardly extending
annular rib 80 disposed and dimensioned to engage in annular
undercut 70 in inner cap 56. More particularly, annular rib 80 is
spaced a distance "e" from distal end 74, which is approximately
equal to or greater than the distance "b" between undercut 70 and
distal end 62 of inner cap 54. Annular rib 80 also defines an
inside diameter "f" which is approximately equal to the outside
diameter "c" defined by the undercut 70 in inner cap 56. Distal
portions of annular rib 80 are chamfered to facilitate deflection
of inner cap 56 during assembly of inner cap 56 and outer cap 58,
as explained further herein.
[0033] Portions of stepped aperture 76 extending between annular
rib 80 and proximal end 72 of outer cap 58 define an inside
diameter "g" which is greater than the outside diameter of tip
engaging portion 64 of inner cap 56, such that tip engaging portion
64 can be loosely engaged therein with room for expansion as the
entire tip cap assembly is urged over tip 22, as explained further
below.
[0034] Exterior portions of outer cap 58 extending distally from
proximal end 72 are characterized by an array of external threads
82. Threads 82 are disposed and dimensioned to threadedly engage
internal threads 52 on luer collar 44 as shown in FIG. 4 above and
described in greater detail below. Exterior portions of outer cap
58 extending proximally from distal end 74 are characterized by
ribs 84 which are dimensioned and configured to facilitate manual
gripping and rotation of outer cap 58.
[0035] Inner and outer caps 56 and 58 are assembled by urging
proximal end 60 of inner cap 56 in a proximal direction into distal
end 74 of outer cap 58. Tip engaging portion 64 of inner cap 56
will engage the chamfer of inwardly extending rib 80 on outer cap
58 and will be deflected inwardly. After sufficient distal movement
of inner cap 56, anti-rotation ribs 68 of inner cap 56 may engage
anti-rotation ribs 78 of outer cap 58. The pointed or tapered
distal shape of anti-rotation ribs 78 will cause inner cap 56 to
rotate slightly, such that anti-rotation ribs 68 of inner cap 56
will align respectively intermediate a pair of adjacent
anti-rotation ribs 78 on outer cap 58. Further advancement of inner
cap 56 into outer cap 58 will cause undercut 70 to align with
annular rib 80. Inner cap 56 then will resiliently return toward an
undeflected condition, such that annular rib 80 of outer cap 58 is
trapped in undercut 70 to substantially prevent further axial
movement between inner and outer caps 56 and 58 respectively. In
this position, the interdigitation of anti-rotation ribs 68 and 78
will prevent or limit rotation between inner and outer caps 56 and
58.
[0036] Assembly 54 of inner and outer caps 56 and 58 can be
threadedly engaged with luer collar 44 as shown in FIG. 2, and the
threadedly engaged cap assembly 54 and luer collar 44 can be urged
onto tip 22 of syringe barrel 12 as shown in FIGS. 3 and 4.
Projections 50 on proximal end 46 of luer collar 44 will deflect
and engage tip 22 for securely retaining luer collar 44 and the
inner and outer caps 56 and 58 threadedly engaged therewith on the
tip 22. Simultaneously, tip engaging portion 64 of inner cap 56
will sealingly engage tip 22. In this regard, tip engaging portion
64 will resiliently engage outer circumferential portions of tip
22, while stopper 67 will pass into and sealingly engage passage 24
through tip 22. In this fully seated position, vent aperture 69
will be blocked by tip 22.
[0037] FIGS. 9 and 10 illustrate alternative syringe barrels having
structure for improving the engagement of projections 50 on
proximal end 46 of the luer collar with the syringe barrel tip. In
particular, alternative syringe barrel 212 includes distal end 216
having tip 222. Recess 226 is provided at the base of tip 222 for
providing a more positive engagement with projection 50 on proximal
end 46 of luer collar 44. Likewise, alternative syringe barrel 312
having distal end 316 and tip 322 includes annular rib 323 for
improving the engagement of the luer collar to the barrel. During
assembly, projections 50 on proximal end 46 of the luer collar must
deflect and snap over annular rib 323 to secure the collar to the
barrel tip. Projections 50 can be angled or chamfered to make the
engagement force substantially less than the force required to pull
the luer collar from the tip. Also, luer collar 44 can be attached
to a syringe barrel tip through the use of other means such as
adhesives.
[0038] The threaded engagement of outer cap 58 with luer collar 44
and the simultaneous engagement of outer cap 58 with inner cap 56
positively prevent inadvertent separation of inner cap 56 from its
sealing engagement with tip 22. However, tip 22 of syringe barrel
12 can be accessed readily by merely rotating outer cap 58 relative
to luer collar 44. Engagement of anti-rotation ribs 68 and 78
ensures that inner cap 56 will rotate with outer cap 58.
Additionally, engagement of annular rib 80 of outer cap 58 with
undercut 70 in inner cap 56 ensures that inner cap 56 will move
axially in response to the threaded disengagement of outer cap 58
from luer collar 44.
[0039] As illustrated in FIGS. 1-7, cap assembly 54 is threadedly
engaged with a thermoplastic luer collar that is mounted to the tip
of a glass syringe barrel. However, cap assembly 54 can be employed
with similar advantages to a thermoplastic syringe barrel having a
luer collar molded thereto. In this regard, FIG. 8 hows a
thermoplastic syringe barrel 112 having a distal end 116 with a tip
122 projecting therefrom. A luer collar 144 projects unitarily from
distal end 116 in spaced concentric relationship about tip 122. Cap
assembly 54, as identified and described above is threadedly
engaged with luer collar 144 such that elastomeric inner cap 56
sealingly engages tip 122 of syringe barrel 112. Unintended
separation of inner cap 56 from tip 122 is substantially prevented
by the threaded engagement of cap assembly 54 with the luer collar
144 unitarily formed with syringe barrel 112. However, tip 122 can
be accessed readily by rotating outer cap 58 for threaded
disengagement from luer collar 144.
[0040] As noted above, misuse of or tampering with medication
pre-loaded in a syringe barrel 112 should be guarded against. To
provide such tamper evidence, a frangible label 86 is adhesively
applied across the interface of the threadedly engaged outer cap 58
and luer collar 144. Label 86 will serve in response to initial
separation of cap assembly 54 from luer collar 44 to provide
unmistakable evidence of tampering with syringe barrel 112 and the
medication therein.
[0041] While the invention has been described with respect to
certain preferred embodiments, it is apparent that various changes
can be made without departing from the scope of the invention as
defined by the appended claims. For example, the inner and outer
caps need not be separate parts that are assembled after
manufacture. Rather, the inner and outer caps may be simultaneously
molded using injection technology or sequential injection
technology. Alternatively, the inner cap or the outer cap may
define an insert in an injection molding cavity in which the other
of the inner and outer caps is molded.
* * * * *