Safety syringe abstract
A disposable safety syringe has a needle shuttle slidably located
within a main syringe barrel. The shuttle has a pair of outwardly
extending guide tabs which engage a guide slot formed in the barrel
wall. The upper end of the needle shuttle is configured to accept
a luer lock needle assembly and has a downwardly extending spike
used to penetrate the septum of an ampoule mounted in the barrel.
A sleeve and rod assembly are mounted in the barrel below the ampoule
and can be used to translate the ampoule from a suspended shipping
position to an injecting position in which the septum is penetrated
by the spike. The sleeve and rod assembly is removed after use,
the spent ampoule is withdrawn and the needle shuttle is maneuvered
downwardly by means of the guide tabs to a locking position in which
the needle assembly is housed within the barrel for safe disposal.
Safety syringe claims
What is claimed is:
1. A disposable syringe for use with an attachable needle assembly
and an ampoule having a main body portion, a dispensing end with
a neck rim, a penetrable closure for the dispensing end and an opposite
end with a piston for expelling the contents of the ampoule, said
syringe comprising:
a main housing having a wall portion with an interior volume, said
wall portion having a guide slot with a tab support portion and
a tab lock portion;
a needle shuttle having a needle attachment portion, a closure
penetrating member with a passageway, a pair of spaced detent members
engageable with the neck rim of an ampoule when located in said
interior volume of said main housing for providing first and second
detent positions for the ampoule, and a guide tab engageable in
said guide slot; and
a sleeve and rod assembly insertable within said interior volume
of said main housing for engaging the opposite end of an ampoule
when located in said interior volume and for shifting the ampoule
within said interior volume from said first detent position to said
second detent position,
said needle closure penetrating member of said needle shuttle being
arranged to penetrate the ampoule closure when the ampoule is shifted
between said first and second detent positions and the needle shuttle
guide tab is located in the tab support portion of the housing guide
slot,
said sleeve and rod assembly further including means engageable
with the ampoule piston for translating the piston towards the dispensing
end of the ampoule to expel the contents via the needle shuttle
passageway,
said needle shuttle maintaining an attached needle assembly within
said interior volume of said main body housing when the needle shuttle
guide tab is located in the tab lock position of said guide slot.
2. The invention of claim 1 wherein said main housing interior
volume includes a limit stop region for limiting movement of said
needle shuttle therealong.
3. The invention of claim 1 wherein said needle attachment portion
of said needle shuttle includes an internally threaded end portion.
4. The invention of claim 3 wherein said internally threaded end
portion is formed with luer lock threads.
5. The invention of claim 1 wherein said needle shuttle closure
penetrating member comprises a spike portion extending longitudinally
of said needle shuttle and located centrally thereof.
6. The invention of claim 5 wherein said needle shuttle passageway
extends centrally of said spike portion.
7. The invention of claim 6 wherein said needle shuttle further
includes an elongated crossbore formed through said spike portion
in communication with said passageway.
8. The invention of claim 1 wherein said needle shuttle includes
a pair of laterally spaced tab portions.
9. The invention of claim 8 wherein said needle shuttle includes
a pair of longitudinally extending wall members; and wherein said
laterally spaced tab portions are formed on one of said wall members.
10. The invention of claim 9 wherein said one of said wall members
is flexible.
11. The invention of claim 1 wherein said sleeve and rod assembly
includes a sleeve member having a first longitudinally extending
bore with a first diameter, a counterbore having a second diameter
larger than said first diameter, and a threaded portion located
intermediate said first bore and said counterbore.
12. The invention of claim 11 wherein said sleeve and rod assembly
further includes a rod member having a threaded portion engageable
with said threaded portion of said sleeve member.
13. The invention of claim 12 wherein said sleeve member is provided
with a longitudinally extending cut-away for enabling said rod member
to be press fitted into said first bore and said counterbore.
Safety syringe descriptionBACKGROUND OF THE INVENTION
This invention relates to a relatively low cost, disposable syringe
designed to reduce or eliminate accidental needle strikes by enabling
selective position control of the needle from an injecting position
to a retracted and locked position.
Hypodermic syringes are used for a variety of injection procedures
including the delivery of medicinal drug and anesthetics to a patient.
Once the injection procedure is completed, problems can arise if
the syringe is not disposed of properly and adequately. Healthcare
workers are susceptible to accidental and potentially infectious
needle strikes if the needle is carelessly handled or broken during
disposal of the syringe after use. If an accidental needle strike
does occur, a blood test is typically required to determine whether
the worker has been infected. The cost of performing such tests
and the loss of personnel time attendant upon such tests can be
particularly damaging to a healthcare facility striving for economy
and efficiency.
There are several known syringes designed to provide retraction
of a syringe needle after use. In some such designs, the apparatus
is designed such that the needle is retracted within the same ampoule
which initially housed the medication dispensed with the syringe.
In other known devices, the retraction mechanism is designed to
retract the used needle within the syringe housing and lock the
needle in the retracted position.
While such known designs have been found suitable in a wide variety
of applications, none is compatible with a standard syringe needle
using the luer-lock design. In the luer lock design, a single ended
needle is bonded to a plastic carrier member, the needle being received
within a central opening formed in the carrier and bonded to the
carrier by suitable adhesive. The carrier is provided with externally
formed threads designed to threadably engage the syringe housing.
Such needles have found wide use, and are available in several standard
sizes. Consequently, the need exists for an economical disposable
syringe which is compatible with the luer-lock type of needle assembly
and which provides safe handling and disposal for such needle assemblies,
as well as other attachable needle assemblies, after use.
SUMMARY OF THE INVENTION
The invention comprises a disposable safety syringe which is designed
for use with the luer lock standard needle assembly, is relatively
simple in design and use, and provides retractable locking for the
needle after use, with the needle being positioned safely within
the syringe barrel.
In the preferred embodiment, the invention includes a main housing
having a wall portion with an interior volume, the wall portion
having a guide slot with a tab support portion and a tab lock portion.
The main housing interior volume preferably includes a limit stop
region for limiting movement of a needle shuttle within the interior
volume.
A needle shuttle dimensioned to be insertable within the interior
volume of the main housing has a needle attachment portion, a penetrating
member with a passageway, a pair of spaced detent members, and a
guide tab locatable in the main housing guide slot. The needle attachment
portion is designed to secure an attachable needle assembly, preferably
a luer lock type needle assembly, and includes an internally threaded
end portion preferably formed with luer lock threads. The closure
penetrating member is designed to pierce a penetrable closure on
the dispensing end of an ampoule when the ampoule is positioned
within the main housing interior volume, the closure penetration
member preferably comprising a spike portion extending longitudinally
of the needle shuttle and located centrally thereof. The closure
penetrating member is formed with a longitudinally extending fluid
passageway, which preferably extends centrally of the spike portion,
and the spike portion is preferably provided with an elongated crossbore
in communicating with the passageway to facilitate the transfer
of liquid therealong. The spaced detent members are engageable with
the neck rim of an ampoule inserted in the main housing interior
volume and provide detent support for the ampoule and two positions
longitudinally of the main housing.
The needle shuttle guide tab enables manipulation of the needle
shuttle between an injection position in which the guide tab is
located in the tab support portion of the guide slot and a lock
position in which the guide tab is located in the tab lock portion
of the guide slot. In the locked position, the needle shuttle maintains
an attached needle assembly within the interior volume of the main
housing so that the needle is locked in a totally retracted position.
The needle shuttle preferably includes a pair of longitudinally
extending wall members, and a pair of laterally spaced guide tabs
formed on one of the pair of wall members. To facilitate insertion
of the needle shuttle within the interior of the main housing, the
wall member on which the guide tabs is located in inwardly flexible.
A sleeve and rod assembly is dimensioned to be inserted within
the interior volume of the main housing for engaging the opposite
end of an ampoule located in the interior volume and for shifting
the ampoule within the interior volume from a first detent position
to a second detent position. The sleeve and rod assembly further
includes means engageable with a slidable piston located within
the ampoule for translating the piston towards the dispensing end
of the ampoule to expel the contents thereof via the needle shuttle
passageway. The sleeve and rod assembly preferably includes a sleeve
member having a first longitudinally extending bore, a counterbore
with a larger diameter than the first bore, and a threaded portion
located intermediate the first bore and the counterbore. The sleeve
and rod assembly further preferably includes a rod member having
a threaded portion engageable with the threaded portion of the sleeve
member so that the sleeve member and the rod member may be moved
in unison or separately. The sleeve member is preferably provided
with a longitudinally extending cut-away for enabling the rod member
to be press fitted into the first bore and the counterbore.
The invention is preferably configured for shipment in two subassemblies:
a first subassembly including the main housing and the needle shuttle,
and a second subassembly comprising the sleeve and rod. An ampoule
may be included in the first subassembly, or may be supplied by
the user. When the ampoule is supplied with the first subassembly,
the ampoule is inserted within the interior of the main housing
and maneuvered to the first detent position in which the penetrable
closure member is located below the tip of the needle shuttle closure
penetrating member. Similarly, the needle assembly may be supplied
by the user or shipped along with the two subassemblies. When shipped
with the two subassemblies, the needle assembly is preferably detached
from the needle shuttle.
In use, the ampoule is inserted in the main housing/needle shuttle
sub-assembly to the first detent position by the user (unless already
supplied), and the needle assembly is attached to the needle shuttle.
Thereafter, the sleeve and rod assembly is inserted into the interior
of the main housing and used to shift the ampoule from the first
detent position to the second detent position. During this movement,
the ampoule closure is penetrated by the needle shuttle closure
penetrating member. Thereafter, the rod is detached from the sleeve,
and the rod is used to force the ampoule piston towards the dispensing
end of the ampoule, thereby expelling the ampoule contents.
After the ampoule contents are expelled, the sleeve and rod are
withdrawn and the ampoule is ejected from the main housing by manipulating
the needle shuttle by means of the guide tab toward the locking
position. The needle assembly, which is attached to the needle shuttle,
is automatically withdrawn within the interior of the main housing
and locked in place by means of the locking engagement between the
needle shuttle guide tab and the tab lock portion of the main housing
guide slot.
For a fuller understanding of the nature and advantages of the
invention, reference should be had to the ensuing detailed description
taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a preferred embodiment of the invention;
FIG. 2 is a sectional view illustrating the preferred embodiment
of the invention prepared for packaging;
FIG. 3 is a side elevational view of the needle shuttle;
FIG. 4 is a sectional view of the invention after penetration of
the ampoule septum; and
FIG. 5 is a sectional view of the invention in condition for disposal
and illustrating the needle in the retracted locked position.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Turning now to the drawings, FIG. 1 is an exploded perspective
view of the preferred embodiment of the invention. As seen in this
Figure, the disposable syringe includes a main body member generally
designated with reference numeral 10 having a barrel portion 12
with oppositely disposed upwardly extending angled finger tabs 13
14 integrally formed at the bottom end thereof, and a beveled nose
portion 15. Extending longitudinally of barrel portion 12 is a guide
slot 16 terminating at the upper end in a laterally extending slot
portion 17. Guide slot 16 also has a pair of mutually facing, inwardly
tapering wall portions 18 terminating in an enlarged, generally
rectangular lock slot portion 20. As best seen in FIG. 2 barrel
12 has an essentially cylindrical inner wall structure terminating
at the upper end in a portion having a reduced diameter and forming
an internal abutment edge 22.
Again with reference to FIG. 1 a one piece needle shuttle generally
designated with reference numeral 25 has a generally cylindrical
upper body section 26 an enlarged circumferentially extending waist
portion 27 and a lower portion consisting of a pair of downwardly
depending wall members 29 30 each having a partially cylindrical
configuration. Formed on wall member 30 is a pair of outwardly extending
guide tabs 34 35 which are laterally spaced by an amount which
ensures a locking fit in lock slot 20 in the manner described more
fully below.
As best seen in FIGS. 1 and 2 the upper body portion 26 of needle
shuttle 25 has an internally threaded annular wall portion 37 and
a centrally located tapered nose portion 38. Needle shuttle 25 also
has a downwardly depending central spike portion 40 provided with
a slightly elongated cross bore 41. A centrally located passageway
43 extends from the cross bore 41 to the top of the nose portion
38.
Lower wall portions 29 30 are each provided with a pair of axially
spaced detent ridges 46 47 which are positioned and configured
to engage the ampoule in the manner described below. It should be
noted that threaded portion 37 of needle shuttle 25 is configured
to accept a luer lock standard needle assembly shown in FIG. 1 and
generally designated with reference numeral 50.
Needle assembly 50 includes a single ended needle 51 bonded within
a unitary housing 52. Housing 52 has an internal passageway 54 (see
FIG. 5) which is slightly tapered at the upper end to facilitate
the insertion of needle 51 and the lower end of needle 51 is bonded
within the lower portion of passageway 54 typically by means of
a suitable adhesive. Needle housing 52 is provided with a pair of
oppositely extending thread engaging tab portions 55 56 designed
to be rapidly engaged with threads 37 formed in the needle shuttle
25.
Again with reference to FIG. 1 a standard medicine cartridge or
ampoule 60 typically fabricated from glass or pharmaceutically
compatible plastic material, has an open lower end 61 and upper
end with a central opening and an enlarged rim 62 (see FIG. 2).
Ampoule 60 is sealed in a known manner using a septum 64 and a metal
band 65 with a central opening formed therein. A sealing piston
67 is located in the bottom interior of ampoule 60 and seals the
fluid contents 68 within ampoule 60 prior to dispensing.
An activation sleeve generally designated with reference numeral
70 has a generally cylindrical main body portion 71 terminating
in an outwardly extending lower flange 72. Sleeve 70 is provided
with a longitudinally extending bore 74 (see FIG. 2) communicating
with an enlarged counter bore 75 dimensioned to accommodate the
bottom end of ampoule 60. An intermediate threaded portion 77 is
provided to enable a activation rod 80 to be removably attached
to sleeve 70 in the manner described below. A portion of main body
member 71 and flange 72 is cut away from sleeve 70 so that the stem
portion 81 of the activation rod 80 can be pressed into the interior
of sleeve 70.
In addition to stem portion 81 activation rod 80 has an upper
threaded section 82 engageable with threaded section 77 of sleeve
70 and a lower enlarged base portion 84.
In use, the device is assembled in the following fashion. The nose
portion 38 of needle shuttle 25 is inserted into the bore of barrel
12 from below and manipulated upwardly. The wall members 29 30
are flexed together in order to permit locking tabs 34 35 to clear
the first portion of the inner wall of barrel 12. Shuttle 25 is
manipulated further upwardly within barrel 12 until the locking
tabs 34 35 extend through the guide slot 16 in barrel 12. Thereafter,
shuttle 25 can be manipulated upperwardly by means of the protruding
guide tabs 34 35 until the shuttle 25 is in the uppermost position
at which the upper edges of the guide tabs 34 35 encounter the
upper edge of the slot portion 17. Thereafter, shuttle 25 is rotated
by means of the guide tabs 34 35 into the slot portion 17 so that
the shuttle is supported by the lower edge of slot portion 17. If
the syringe is to be shipped with the ampoule 60 ampoule 60 is
now inserted via the bottom opening in barrel 12 and maneuvered
upwardly therein until the lower edge of rim 62 passes the lower
detent ridges 46 formed in shuttle 25. Ampoule 60 is now supported
within barrel 12 in the attitude illustrated in FIG. 2 in which
the tip of the spike 40 is positioned above band 65 and septum 64.
The stem 81 of rod 80 is pressed fitted into shuttle 70 and may
be threadably attached by rotating rod 80 in the proper direction.
This shipping configuration for the invention is illustrated in
FIG. 2. In some applications, the end user will supply the needle
assembly 50: in such applications, the two subassemblies illustrated
in FIG. 2 are shipped in the package to the user. In other applications,
the needle assembly 50 is supplied along with the two subassemblies
in the same package.
When the syringe is scheduled to be used for an injection, the
upper end of sleeve 70 is inserted into the lower end of barrel
16 and maneuvered upwardly until the lower end of ampoule 60 is
snugly received in counter bore 75 of sleeve 70. Next, an upward
force is applied by the user to sleeve 70 by means of rod 80 which
causes sleeve 70 to force ampoule 60 upwardly to the second detent
position illustrated in FIG. 4 in which the rim 62 of ampoule 60
is engaged by upper detent ridges 47. As seen in FIG. 4 in this
position, spike 40 has pierced through the septum 64 and is located
within the interior of ampoule 60 with the cross bore 41 immersed
in the liquid within ampoule 60. Although not illustrated in FIG.
4 (due to space limitations), it is envisioned in normal use that
the needle assembly 50 will be threaded onto the needle shuttle
25 prior to piercing of the septum 64.
Next, rod 80 is rotated in the appropriate direction to release
rod 80 from sleeve 70 and permit free upper translation of rod 80
within barrel 12. This causes piston 67 within ampoule 60 to be
translated upwardly and expel the contents of ampoule 60 via cross
bore 41 passageway 43 and needle 51.
After the contents of ampoule 60 have been expelled by the required
amount, rod 80 and sleeve 70 are manually withdrawn through the
bottom opening in barrel 12. Thereafter, needle shuttle 25 is rotated
by rotating guide tabs 34 35 to the guide slot 16 and needle shuttle
25 is manipulated downwardly until the guide tabs 34 35 are engaged
in the lock slot 20. As the needle shuttle 25 is manipulated downwardly,
the needle assembly is withdrawn into the interior of barrel 12
until the position illustrated in FIG. 5 is achieved. As seen in
this Figure, the needle 51 is locked in place entirely within the
barrel 12. Both subassemblies illustrated in FIG. 5 may now be disposed
of.
As will now be apparent, disposable syringes fabricated according
to the teachings of the invention are completely compatible with
standard luer lock needle assemblies, and provide a safe and economical
technique for disposing of used luer lock type needles. In addition,
the invention affords additional protection by virtue of the fact
that the needle need only be attached to the syringe just prior
to puncturing the septum 64 in the ampoule 60. Further, during installation
of ampoule 60 inadvertent pressure buildup within the ampoule 60
due to the accidental application of force to the bottom of piston
67 can be completely avoided by using the shuttle 70 and rod 80
to maneuver the ampoule 60 upwardly into the second detent position.
In addition, due to the simplicity of the design of the invention,
the ampoule 60 may be readily inserted at the user end in those
applications in which it is not desired to transmit the ampoule
60 from the syringe supplier to the user.
While the above provides a full and complete disclosure of the
preferred embodiment of the invention, various modifications, alternate
constructions and equivalents may be employed as desired. For example,
although expressly designed for use with luer lock type needle assemblies,
the device can be adapted for use with any other type of standard
or custom designed attachable needle assemblies in which the needle
is housed in a base capable of interlocking engagement with a needle
shuttle. Therefore, the above description should not be construed
as limiting the scope of the invention, which is defined by the
appended claims. |