U.S. patent number 3,783,997 [Application Number 05/248,222] was granted by the patent office on 1974-01-08 for syringe package.
This patent grant is currently assigned to Sherwood Medical Industries Inc.. Invention is credited to Alexander M. Brown.
United States Patent |
3,783,997 |
Brown |
January 8, 1974 |
SYRINGE PACKAGE
Abstract
A package for a hypodermic syringe having a relatively shiftable
barrel and needle assembly for arming the syringe is provided which
includes a needle sheath engageable with the needle assembly for
arming the syringe when unpackaged, and a sleeve member encircling
the syringe and holding the proximal end portion of the sheath
radially inwardly against a portion of the syringe to prevent
inadvertent arming.
Inventors: |
Brown; Alexander M. (Daytona
Beach, FL) |
Assignee: |
Sherwood Medical Industries
Inc. (St. Louis, MO)
|
Family
ID: |
22938190 |
Appl.
No.: |
05/248,222 |
Filed: |
April 27, 1972 |
Current U.S.
Class: |
206/365; 604/201;
604/193 |
Current CPC
Class: |
A61M
5/3202 (20130101); A61M 5/002 (20130101); A61M
5/24 (20130101); A61M 2005/247 (20130101); A61M
2005/2407 (20130101); A61M 5/2466 (20130101) |
Current International
Class: |
A61M
5/24 (20060101); A61M 5/00 (20060101); A61M
5/32 (20060101); A61m 003/00 (); B65d 085/54 () |
Field of
Search: |
;206/17.5,43,63.2R,16.5
;128/218D,218NV,218P,218N,218R,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Dixson, Jr.; William T.
Claims
What is claimed is:
1. A package for a syringe and a needle assembly that are
relatively movable from an unarmed condition to an armed condition
comprising a generally cylindrical cover member having an open
proximal end and including a main cover portion receiving the
syringe and a reduced diameter open distal end portion having a
smaller inner diameter than that of said main cover portion, and a
sheath engageable with the needle assembly for assisting in
effecting relative axial movement between the syringe and the
needle assembly to arm the same, said sheath including a main
sheath portion shielding the needle assembly, and a radially
outwardly flexible proximl end portion having a larger inner
diameter than that of said main sheath portion and received in said
main cover portion between a portion of the syringe adjacent the
distal end thereof and said distal end portion of said cover member
for limiting relative axial movement between the syringe and said
sheath, and means connected to said cover member for closing said
open end of said cover, member the inner walls of said main cover
portion being disposed closely adjacent said proximal end portion
of said sheath for preventing radially outward movement thereof to
prevent relative axial movement between the syringe and said sheath
to thereby obviate inadvertent arming of the syringe and needle
assembly in the packaged condition thereof, the syringe and needle
assembly and said sheath being movable together through said open
end of said cover member to remove said cover member therefrom, the
syringe and said sheath being relatively axially movable toward
each other in response to applied forces thereon when said cover
member is removed therefrom to effect flexing of said proximal end
portion of said sheath radially outwardly from said syringe portion
to effect relative axial movement between said syringe and needle
assembly for arming the syringe and needle assembly.
2. The package according to claim 1 wherein said cover member and
said sheath are formed of plastic material.
3. The package according to claim 2 wherein said proximal end
portion of said sheath is generally cylindrical and has a plurality
of slots extending axially from the proximal extremity thereof
defining a plurality of resilient fingers.
4. The package according to claim 1 wherein said distal end portion
of each cover member defines a collar surrounding said main sheath
portion.
5. The package according to claim 1 wherein in the syringe has a
barrel with a radially inwardly extending distal end, and said
sheath is engageable with said distal end of said barrel in the
packaged conditon.
Description
BACKGROUND OF THE INVENTION
This invention relates to packages for syringe and needle
assemblies, and more particularly to a package for a unit dose or
prefilled hypodermic syringe and needle assembly of the type in
which the syringe barrel and needle assembly are relatively
shiftable to effect arming thereof.
U.S. Pat. No. 3,008,570, assigned to the same assignee as the
present application, discloses a package for a hypodermic syringe
and needle assembly having a needle sheath and enclosing sleeve
member which are relatively movable for removing the hypodermic
syringe and needle assembly from the package. The syringe and
needle assembly, however, are not of the shiftable type and the
package does not require means for preventing inadvertent arming of
the syringe. In application Ser. No. 26,681, filed Apr. 8, 1970,
and assigned to the same assignee as the present application, a
package for a unit dose or prefilled syringe having a shiftable
syringe barrel and needle assembly is provided with means for
preventing inadvertent arming of the needle while providing a
sheath which can be utilized in arming the syringe and needle
assembly. While this package has proved very satisfactory in use,
prior packages for syringe and needle assemblies of the shiftable
type have been relatively complicated and expensive in construction
in order to ensure that the assembly cannot be inadvertently armed
when packaged, while at the same time, provide a sheath portion of
the package which can be used to safely assist in the arming of the
syringe and needle assembly.
SUMMARY OF THE PRESENT INVENTION
It is therefore an object of the present invention to provide an
improved package for a unit dose or prefilled syringe and needle
assenbly.
Another object of the present invention is to provide a package for
a syringe and needle assembly of the type that are relatively
movable to effect arming thereof wherein the package is
characterized by simplicity and economy of construction, which
prevents the inadvertent arming of the syringe and needle assembly,
and wherein the package includes a sheath for assisting in the
arming when in an unpacked condition.
Yet another object is to provide a packaged syringe and needle
assembly which is characterized by ease of operation and use and
which prevents inadvertent arming of the syringe and needle
assembly in the packaged condition, yet assists in arming the
syringe and needle assembly when in an unpackaged condition.
In accordance with one form of the present invention a package for
a syringe and needle assembly of the type that are relatively
movable to effect arming is provided that includes a needle sheath
having a proximal end portion engageable with a portion of the
syringe for preventing arming of the syringe and needle assembly
and which is movable radially outwardly away from the syringe
portion to permit arming, and a cover member adapted to encircle
the proximal end portion of the sheath to preent radial movement
thereof and arming of the syringe and needle assembly.
These and other objects and advantages of the present invention
will become apparent from the following detailed description and
accompanying drawings .
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a longitudinal cross-sectional view of a syringe package
according to the present invention enclosing a syringe and needle
assembly;
FIG. 2 is an enlarged cross-sectional view of a portion of the
package and syringe and needle assembly of FIG. 1 with the syringe
and needle assembly armed; and
FIG. 3 is a perspective view of the needle sheath of FIG. 1.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to the drawings, there is shown in FIG. 1 a
hypodermic syringe and needle assembly 10 disposed within a syringe
container or package 12. The syringe and needle assembly 10 is of
the unit dose or prefilled type that includes a syringe 14 and
needle assembly 15 which are relatively axially movable or
shiftable between an unarmed position (FIG. 1) and an armed
position (FIG. 2), as will be discussed more fully hereafter.
The syringe 14 is shown including a barrel 16 open at its proximal
end and having a main reservoir portion 17, and a distal end
portion 18 of reduced diameter which is connected by a generally
radially inwardly extending portion 19 to the main portion 17. The
barrel 16 is also provided with an enlarged flange 20 at its
proximal end which is adapted to be engaged by the fingers during
use of the assembly 10. A connector 21 is shown having an enlarged
annular portion 22 secured to the distal end portion 18 of the
barrel, such as by crimping it over a shoulder 23 provided on the
end portion 18. The connector 21 is provided with an integral,
radially inwardly extending wall 24 and an axially extending
cylindrical portion 26. A seal 27, shown as a relatively thin
rubber diaphragm member, is disposed in the connector 21 between
the distal end of barrel 16 and the interior side of wall 24 to
normally close the distal end of the barrel.
The hypodermic needle assembly 15 is shown including a plastic hub
29 having a double ended cannula 30 connected thereto. The cannula
30 is shown connected to a metal ferrule 32, which may be swaged
thereon, which is secured to the hub 29, for example, by molding
the hub onto the ferrule or by a suitable cement. The hub 29 is
also provided with an annular flange 34. The needle 30 is shown in
the drawings extending through the hub and being pointed at both
the distal end and proximal end thereof. The hub 29 has an internal
bore which slidingly receives the axial portion 26 of the connector
21 with the proximal end of the needle 30 disposed within the
portion 26 of the connector. The internal walls of the hub bore
frictionally engage the outer surface of the axial portion 26. An
annular bead in the hub bore, indicated at 35, is shown in FIG. 1
between a pair of external annular beads 37 provided on the portion
26 of the connector 21 to position and frictionally hold the needle
assembly 10 on the connector in the unarmed position. The hub, when
moved axially towards the barrel, is slidable over beads 37 and
another annular bead 39 and into fluid tight sealing engagement
with the connector 21 in the fully armed position of the syringe
and needle assembly 15, the position shown in FIG. 2. In this
position, the proximal end of the needle cannula pierces the rubber
diaphragm 27 and is in fluid communication with the interior 17 of
the syringe barrel 16.
The package 12 completely encloses the syringe and needle assembly
10 to protect and maintain it in a sterile condition, and also to
prevent the syringe and needle assembly from being inadvertently
armed prior to use. The package 12 includes a needle sheath 40, a
cylindrical cover member or protective sleeve 42 connected to the
sheath, and an end cap 44. In the illustrative embodiment, a hollow
elongated piston rod for the syringe is shown at 46 surrounding and
attached to the sheath 40. An annular groove 47 on the interior
surface of the rod 46 is shown disposed over a bead 48 provided on
the exterior of the sheath 40 so as to maintain the piston rod 46
frictionally attached to the package 12. The rod 46 is provided
with a flange 49 at its proximal end for engagement by the thumb of
a user, and with a reduced diameter threaded end portion 50 at its
distal end which is adapted, during use of the syringe, to be
inserted into a threaded opening 51 in a piston 52, such as a
rubber piston, shown disposed in the barrel 14 in FIG. 1. If
desired, the sleeve 42 may be made long enough so that the piston
rod, such as rod 46, can be enclosed therein instead of positioning
it exteriorally of the sheath as shown in the illustrated
embodiment.
The cover member or sleeve 42 has an enlarged portion at the
proximal end thereof for fitting over the flange 20 of the barrel
16. The cap 44 is secured, for example, by a heat seal, to the
proximal end of the cover member to close the same and is shown
having a pair of resilient integral tabs 54 which engage the
proximal end of the barrel 16 to limit movement thereof. Cover
member 42, in the illustrated embodiment, is provided with a
reduced collar 56 at the distal end thereof which is connected by a
radially inwardly extending portion 57 to the main cylindrical
cover portion indicated at 58. The sheath 40, as seen in FIG. 1,
covers the needle assembly 15 and extends into the cover member.
The needle sheath 40 includes a main, generally tubular or
cylindrical portion 60 which is closed at the distal end thereof,
and an enlarged diameter proximal end portion 62. An integral
radially outwardly extending portion, indicated at 64, connects end
portion 62 with the main portion 60. The proximal end portion 62 is
of greater diameter than the main portion 60 of the sheath and the
collar 56 of cover member 42 to retain the sheath within the
sleeve. The collar 56 frictionally engages the main portion 60 of
the sheath.
The sheath 40 is preferably formed of a plastic material such as
polypropylene, with the proximal end portion 62 made sufficiently
flexible to flare outwardly or move radially outwardly when
unrestrained and in response to an applied force acting to move the
syringe and sheath toward each other. This may be accomplished by
forming the end portion 62 with one or more slots 66 and fingers
68. In the illustrated embodiment, and as more clearly seen in FIG.
3, the proximal end portion 62 is formed with four circumferently
spaced axially extending slots 66 defining four flexible axial
fingers 68.
As seen in FIG. 1, the proximal end portion 62 of the sheath
engages a radially extending portion of the syringe which, in the
drawing, is the radially inwardly extending portion 19 of the
barrel 16 to limit relative movement of the sheath 40 and syringe
14. The fingers 68 extend closely between connector portion 22 and
the interior wall of the main portion 58 of the cover member 42,
and the proximal end of each finger engages the portion 19 of the
barrel 16. Thus, in the packaged condition of syringe and needle
assembly 10, movement of sheath 40 and needle assembly 15 toward
the syringe 14 are positively prevented since the fingers 68 of end
portion 62 engage the syringe 14 and are restrained against radial
outward movement by the cover member 42. Also, the end portion 62
of the sheath is restrained against radial inward movement by the
portion 22 of the connector 21. The interior wall of the radially
outwardly extending portion 64 of the sheath engages the proximal
end flange 34 of needle hub 29 for moving the hub and assisting in
the arming of the syringe and needle assembly during use, as will
be discussed hereinafter, but the sheath cannot move the hub toward
the barrel 16 to effect arming in the packaged condition shown in
FIG. 1 even if forces are applied to the sheath and cover member 42
tending to move them together. With the proximal end portion 62
engaged between the barrel portion 19 and the radial portion 57 of
the cover, the sheath 40 and syringe 14 are immovable in either
direction relative to the cover 42 in the packaged condition of the
assembly.
When it is desired to use the hypodermic syringe and needle
assembly 10, the end cap 44 is removed from the cover by breaking
the heat seal, for example, and piston rod 46 is removed by sliding
it forwardly from the sheath 40. The rod 46 may then be threadedly
connected with the piston 50. The sheath 40 and cover member 42 are
then grasped and urged toward each other to effect relative
movement therebetween so that the syringe and needle assembly 10,
with the sheath 40 disposed thereon, is moved through the cover 42
to thereby remove the cover from the assembly 10. At this point,
the assembly 10 is still unarmed and the sheath is enclosing the
needle 30 and in frictional engagement with the connector 21. The
assembly 10 and sheath 40 can be handled and, for example, placed
on a hard surface without danger of damage or loss of sterility to
the needle.
In order to now arm the syringe or needle assembly 10, that is to
connect the needle lumen in fluid communication with the interior
of the syringe, the syringe barrel 16 and sheath 40 may be manually
grasped and urged toward each other to effect relative axial
movement between the needle assembly 15 and the barrel 16. During
this relative movement, the fingers 68 of the proximal end portion
62 of the sheath flex or move radially outwardly off of the radial
extending portion 19 of the syringe and over the periphery of the
barrel member 16, as shown in FIG. 2, while the radial portion 64
of the sheath engages the flange 34 of the needle hub 29 carrying
the needle assembly 10 toward the barrel 16 until the hub flange 34
engages the radial extending portion 24 of the connector 21 of the
syringe. During this arming of the assembly 10, the proximal end of
the needle 30 pierces the seal 27 to connect the needle in fluid
communication with the interior of the barrel 16. In the armed
position the internal surface of the hub, of course, is sealingly
engaged with the connector 21, as previously mentioned herein. With
the syringe and needle assembly 10 in an armed condition, the
sleeve may be removed in a direction away from the barrel 16 when
it is desired to use the syringe and needle assembly, for example,
for the injection of a medicament. As will be noted, the sheath 40
and the needle assembly 15 remain together as they are removed from
the cover 42 so that the sheath continuously shields the needle
assembly until it is desired to use the syringe.
While the sheath portion 62 in the illustrated embodiment engages
the radial portion 19 of the barrel, it will be apparent that with
slight modification, the portion 62 may engage the radial portion
24 of connector 21 of the syringe.
It is now apparent that applicant has provided an economical and
effective package for a syringe having a sheath of simple and
economical construction for preventing the inadvertent arming of
the syringe and needle assembly while in the packaged condition,
and which can be used in assisting in the arming of the syringe and
needle assembly. Also, the parts of the package may be formed of a
suitable plastic material, for example, polypropylene, so that the
device may be of the single-use or disposable type.
It should be understood, that, although this invention has been
described with reference to the illustrated embodiment,
modification thereto may be made without departing from the true
spirit and scope of the invention.
* * * * *