U.S. patent number 3,721,241 [Application Number 05/026,681] was granted by the patent office on 1973-03-20 for rigid container assembly for syringe.
This patent grant is currently assigned to Sherwood Medical Industries, Inc.. Invention is credited to John W. Beld, Robert Klohr, Elmer A. Koenig, Edward R. Tascher.
United States Patent |
3,721,241 |
Klohr , et al. |
March 20, 1973 |
RIGID CONTAINER ASSEMBLY FOR SYRINGE
Abstract
A rigid packaging container assembly for protecting, and
assisting the arming of a sealed prefilled syringe barrel and
insertable needle assembly including a sheath surrounding the
needle assembly, slidable on the barrel and having a shoulder which
engages a portion of the needle assembly to permit the operator to
grasp the sheath and fully insert the needle assembly from a
partially inserted position, with a sheath retainer surrounding the
sheath and having a plurality of shelf projections extending
through openings in the sheath and engageable with the underside of
the syringe barrel to limit sliding movement of the sheath retainer
upwardly along the syringe barrel so that a cooperating cap
insertable within the sheath retainer and engageable with a portion
of the sheath prevents movement of the sheath when the syringe is
in its packaged condition thereby preventing arming of the syringe
until the cover or cap is removed. There are also provided a
plurality of tabs extending from the sheath so that in the
disassembled condition of the container with only the sheath
surrounding the needle assembly, the syringe will not be permitted
to roll on a supporting surface.
Inventors: |
Klohr; Robert (Fenton, MO),
Tascher; Edward R. (Manchester, MO), Beld; John W.
(O'Fallon, MO), Koenig; Elmer A. (Kirkwood, MO) |
Assignee: |
Sherwood Medical Industries,
Inc. (N/A)
|
Family
ID: |
21833235 |
Appl.
No.: |
05/026,681 |
Filed: |
April 8, 1970 |
Current U.S.
Class: |
604/192; 604/206;
604/242 |
Current CPC
Class: |
A61M
5/3202 (20130101); A61M 5/24 (20130101) |
Current International
Class: |
A61M
5/24 (20060101); A61M 5/32 (20060101); A61m
005/00 () |
Field of
Search: |
;128/215,218R,218N,218NV,218S,218C,218D,218P,220,221 ;206/43 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Mancene; Louis G.
Assistant Examiner: Lever; J. Q.
Claims
We claim: of
1. A sheath and cap assembly for a syringe of the type having a
barrel, a connector and a needle assembly insertable in said
connector, comprising: a needle assembly sheath engageable
laterally with a portion of said needle assembly, said sheath
having an annular upper portion surrounding and engaging the lower
portion of the syringe barrel, said sheath having a shoulder
engageable with a portion of said needle assembly to shift the
needle assembly from a partly inserted to a fully inserted position
in said barrel, a sheath retainer surrounding and engaging said
sheath and having a plurality of radially inwardly projecting
shoulders engageable with said barrel to limit movement on the
sheath retainer and to prevent the sheath retainer from activating
the sheath to insert the needle assembly, projection means on said
sheath and extending within said sheath retainer, and a syringe cap
insertable within said sheath retainer and engageable with said
sheath projection means to prevent movement of the sheath toward
the barrel.
2. A sheath and cap assembly for a syringe of the type having a
barrel, a connector and a needle assembly insertable in said
connector as defined in claim 1, wherein said sheath has a
plurality of openings therein for exposing the bottom portion of
the barrel to the radial projections of the sheath retainer,
camming lobes on said sheath retainer for relatively positioning
said openings with said sheath retainer projections upon relative
movement between said sheath and said sheath retainer.
3. A sheath and cap assembly for a syringe of the type having a
barrel, a connector and a needle assembly insertable in said
connector as defined in claim 2, wherein said sheath has a
plurality of tabs extending radially outwardly and defining said
sheath projection means, said cap having an end portion engageable
with said tabs and selectively preventing movement of said sheath
toward the barrel.
4. A sheath assembly for a syringe having a barrel and a
self-connecting needle assembly, comprising: a sheath for said
needle assembly, means on said sheath engageable with said needle
assembly when in a partly inserted position in said barrel for
moving said needle assembly to a fully inserted position, said
sheath having openings therethrough exposing portions of said
barrel, a sheath retainer engageable with and surrounding said
sheath and having shelf projections extending through said openings
and engageable with said barrel to limit axial movement of the
sheath retainer to a position wherein the sheath does not insert
the needle assembly, and other means selectively engageable with
said sheath and said sheath retainer to prevent relative movement
therebetween when the sheath is in a position where the needle
assembly is partly inserted, said sheath having means engageable
with said barrel to limit lateral movement of the barrel with
respect to the needle assembly.
5. A sheath assembly for a syringe having a barrel and a
self-connecting needle assembly as defined in claim 4 including
means for rotatably aligning the openings and the shelf projections
in response to axial movement of the sheath retainer with respect
to the sheath.
6. A sheath assembly for a syringe having a barrel and a
self-connecting needle assembly as defined in claim 4 wherein said
sheath has a plurality of generally radially extending tabs for
preventing rolling of the syringe with the sheath in position, said
other means selectively engageable with the sheath and the sheath
retainer being engageable with said tabs to prevent movement of
said sheath relative to the barrel to prevent a full insertion of
the needle assembly.
7. A sheath assembly for a syringe having a barrel member, and a
needle assembly connected to said barrel member for relative
movement therewith between an unarmed position and an armed
position in which an interior end portion of the needle assembly is
in fluid communication with the interior of said barrel member,
comprising a removable sheath member surrounding and protecting an
exterior portion of said needle assembly and movable in a direction
toward said barrel member in response to a manually applied force
thereon in said direction to move said needle assembly in said
direction to the armed position, a sheath retainer member connected
with and surrounding said sheath member and extending adjacent said
sheath member for only a portion of the length of said sheath
member, a removable cover member separably connected in engagement
with said retainer member in the assembled condition of the sheath
assembly, and engagement means on said sheath member engageable
with at least one of the other of said members in the assembled
condition of the sheath assembly to limit relative movement between
said sheath member and said barrel member for preventing movement
of said needle assembly to the armed position.
8. The sheath assembly according to claim 7 wherein one of said
members includes other engagement means engageable with said barrel
member to limit axial movement of said barrel member toward said
sheath member when the sheath assembly is in the assembled
condition.
9. The sheath assembly according to claim 8 wherein said other
engagement means is integrally connected with said retainer
member.
10. A sheath assembly for a syringe having a barrel member, and a
needle assembly connected to said barrel member for relative
movement therewith between an unarmed position and an armed
position in which an interior end portion of the needle assembly is
in fluid communication with the interior of said barrel member,
comprising a removable sheath member surrounding and protecting an
exterior portion of said needle assembly and movable in a direction
toward said barrel member in response to a manually applied force
thereon in said direction to move said needle assembly in said
direction to the armed position, a sheath retainer member
engageable with and surrounding said sheath member, a removable
cover member connected with said retainer member in the assembled
condition of the sheath assembly, and engagement means on said
sheath member engageable with at least said cover member in the
assembled condition of the sheath assembly whereby said sheath
member is maintained substantially immovable relative to said
retainer and cover members to limit relative movement between said
sheath member and said barrel member for preventing movement of
said needle assembly to the armed position, said retainer member
having a reduced annular portion slidable on said sheath member and
an integral enlarged annular portion connected to said cover
member, said cover member being closed at one end thereof, and said
sheath, retainer, and cover members together enclosing the entire
syringe in the assembled condition of the sheath assembly.
Description
BACKGROUND OF THE PRESENT INVENTION
There have in the past been provided various types of syringes for
injecting medicament into a patient. These syringes generally
require direct operator contact during arming and use. One type of
syringe of this general construction is a prefilled single dose
syringe where the barrel is filled with the proper medicament prior
to inserting a self-connectable needle assembly through a
pierceable seal at the bottom of the syringe barrel. Such syringes
have in the past required the operator during arming to manually
grasp the needle assembly and force it upwardly through the seal
into communication with the medicament within the syringe barrel.
This increases the likelihood of contaminating the syringe as well
as damaging the syringe and needle assembly. The likelihood of
damage is particularly acute in present day syringes where they are
constructed as inexpensively as possible, consistent with safe use,
to permit the entire syringe and needle assembly to be disposed of
after a single use.
It is therefore a primary object of the present invention to
provide a rigid sheath and container assembly for a prefilled
syringe that protects the syringe and needle assembly from
contamination of damage, and assists in arming the syringe in a
proper manner preparatory to injection of the medicament into the
patient.
SUMMARY OF THE PRESENT INVENTION
In accordance with the present invention a rigid sheath and
container assembly is provided for a prefilled syringe of the type
having a needle assembly shiftable from an inactive position out of
communication with the medicament within the syringe barrel to an
active position in full communication preparatory to patient
injection. A sheath is provided for the needle assembly which
serves the twofold function of protecting the needle assembly as
well as inserting the needle assembly to its fully armed position
as the operator grasps the sheath and urges it upwardly toward the
cylinder barrel.
It is however undesirable that the sheath be permitted to "arm" the
syringe inadvertently and to prevent this means are provided for
limiting upward movement of the sheath when the container is in its
assembled condition. Toward this end an annular sheath retainer
member is slidable over the sheath. A plurality of inwardly
projecting shelf members from the retainer extend through openings
in the sheath and engage the lower end of the cylinder barrel to
prevent movement of the retainer upwardly. A cover for the syringe
is insertable within the retainer and engages tabs on the sheath
within the retainer, preventing relative movement between the
sheath and the sheath retainer when the container is assembled.
Since the retainer cannot move upwardly relative to the cylinder
barrel and since the cover prevents relative movement between the
sheath and the sheath retainer, the sheath is prevented from arming
the syringe by being locked from moving toward the cylinder barrel
when the cover or syringe cap is in position.
For the purpose of aligning the openings in the sheath with the
projections in the retainer as the retainer is slid over the
sheath, a plurality of camming lobes are provided on the sheath
retainer which engage the tabs on the sheath retainer to rotate the
same to the proper angular orientation with respect to the sheath
as the sheath retainer is moved upwardly around the sheath.
Moreover the sheath tabs, described above, serve also to prevent
rolling of the syringe on any horizontal surface that it may be
placed after removal of the sheath retainer and cover.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a sheath and container assembly for
a syringe according to the present invention;
FIG. 2 is a perspective view of a sheath and container assembly for
a syringe accordingly to the present invention with the container
cap removed from the assembly;
FIG. 3 is a partly fragmentary exploded view of the sheath and
sheath retainer, somewhat enlarge from the FIGS. 1 and 2;
FIG. 4 is a top elevation of the sheath retainer;
FIG. 5 is a top elevation of the sheath with the sheath retainer in
its surrounding position;
FIG. 6 is an exemplary prefilled syringe with which the present
sheath and container assembly may be advantageously employed;
FIG. 7 is an enlarged fragmentary section of the present sheath and
container assembly with the syringe shown in its unarmed position
taken generally along line 7--7 of FIG. 5; and
FIG. 8 is a fragmentary section taken generally along line 8--8 of
FIG. 5 illustrating another portion of the sheath and retainer
assembly in position with an unarmed syringe.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to the drawings and particularly FIGS. 1 and 2, the
present sheath and container assembly 10 is illustrated adapted for
use use in protecting a single dose syringe prior to use and
assisting in arming the syringe preparatory to use. The assembly 10
consists generally of a needle assembly sheath 12 which protects
the needle assembly and assists in arming the syringe, and a sheath
retainer 14 that assists in controlling arming movement of the
sheath 12 and serves as one end of an integral cap 16. The
container 10 is adapted to protect and assist in arming a syringe
of the general type shown at 18 in FIGS. 2 and 6.
Such syringes are seen to consist of a cylindrical barrel member
20, a connector 21, a needle assembly 24 and a plunger assembly 25.
The connector 21 has a puncturable seal therein such as shown at 26
in FIG. 7 and a friction fitting 28 that receives and holds a
fitting 30 in both a lower unarmed position such as shown in FIG. 7
and a fully seated armed position (not shown) in which flange 32
engages the underside portion 33 of the connector 21. During
movement from the unarmed position, in which the fitting 30 is
frictionally retained on connector portion 28, to the armed
position of the needle assembly 24, a pointed end 36 of needle 38
pierces the seal 26 and provides communication between the needle
and the interior of barrel 20. One advantage in this type of
syringe is that it may be prefilled sometime prior to use and
requires only a small shifting movement of the needle assembly 24
to arm the syringe and break the aseptic seal.
The syringe 18 is filled with the plunger assembly 25 removed and
thereafter the plunger assembly 25 is inserted with a resilient
piston 40 squeezed within an opening 41 in a tubular sleeve 42.
After the piston 40 on a plunger 43 of the assembly 25 contacts the
medicament within the barrel 20, it is in the position of FIG. 2,
then the sleeve 42 is pulled upward relative to the plunger 43 for
releasing the piston 40 within the barrel 20 and sealing the
medicament within the barrel free from air contamination.
During packaging, with the needle assembly 24 in its frictionally
retained, but unarmed position shown in FIG. 7, the sheath 12 is
inserted over the needle assembly to the position shown in FIG. 7.
As shown clearly in FIGS. 3 and 7, the sheath 12 includes a
tapered, closed lower portion 46 extending a significant distance
below the needle 38, a slightly tapered frusto-conical portion 48
having ribs 49 which are sized to engage the sides of needle
fitting 30 and also having a shoulder 52 which engages the
underside of the needle fitting flange 32. The sheath 12 has an
enlarged annular portion 55 extending upwardly from the
frusto-conical portion 48 and having a plurality of inverted
V-shaped openings 56 therein which, when in the position shown in
FIGS. 7 and 8, expose portions of the lower end of barrel member 20
for a purpose more fully described hereinafter. Extending radially
outwardly adjacent the juncture of the sheath sections 48 and 55
are three triangularly shaped, radially projecting tabs 58 which
serve both to prevent rolling of the syringe when protected only by
the sheath 12 and also to assist in locking the sheath against
inadvertent arming.
The annular upper portion 55 of the sheath 12 has ribs 78 thereon
as shown in FIG. 8 which slidably engage the outside of the barrel
20 so that the barrel may be snugly received therein. This fit in
conjunction with the ribs 49 on the sheath engaging the fitting 30
of the needle assembly 24 maintains proper alignment between the
needle assembly and the syringe barrel 20.
After the sheath 12 is positioned as shown in FIG. 7, the sheath
retainer 14 is inserted over the lower end of the sheath 12 and
moved upwardly to the position shown in FIG. 7. As shown more
clearly in FIGS. 3 and 7, the sheath retainer 14 has a reduced
annular portion 60 which slides over and engages the slightly
conical portion 48 of sheath 12. Interconnected with portion 60 is
a main enlarged annular portion 62 which has a ribbed outer surface
63 as shown in FIG. 3 to facilitate manipulation. Projecting
upwardly from a lower annular wall 65 of the retainer 14 are three
arcuate, axially extending segments 67 having upper shelf portions
68 that engage the underside of barrel member 20 for the purpose of
limiting the upward movement of the retainer 14 with respect to the
barrel member 20. The segmental projections 67 are of sufficient
length so that the retainer 14 when shifted axially to its limit
position shown in FIG. 7, will not move the sheath 12 to a position
causing arming of the needle assembly 24. The segmental projections
67 each extend within one of the inverted V-shaped openings 56
shown in FIG. 3 in the sheath 12.
For the purpose of rotatably aligning the segmental projections 67
on the sheath retainer 14 with the openings 56 in the sheath as the
retainer is moved axially up the sheath toward the position of FIG.
7, V-shaped, arcuate segmental cam lobes 70 are provided also
extending upwardly from the base 65 of the retainer 14. The
V-shaped upper surfaces 72 of the lobes 70 engage the triangularly
shaped radial tabs 58 on the sheath 12 as the retainer 14 is
inserted rotating the segmental projections 67 into alignment with
the openings 56. As seen more clearly in FIGS. 4 and 5, an
interconnecting web portion 75 extends radially between each of the
segments 67 and the adjacent lobe 70. As seen in FIGS. 5 and 7, the
annular portion 55 of the sheath fits between the lobes 70 and the
segments 67 on the retainer 14.
For the purpose of preventing the upward arming movement of the
sheath 12 when the cover 16 is in position, the cover has an
annular lower portion 79 of sufficient length so that it engages
the upper surface of the tabs 58 on the sheath 12. The frictional
engagement between the annular portion 79 and the inside of the
retainer 14 in conjunction with an annular retainer lip 82,
releasably lock the cover to the retainer, although the retension
force may be overcome manually during disassembly. This retension
force however is sufficient to prevent relative movement between
tabs 58 and the retainer 14 which, in turn, through the action of
the shelf portions 68 prevent the upward movement of the sheath 12
when the cover 16 is in position. Thus the operator may not arm the
syringe while the cover or cap 16 is in the position shown in FIGS.
7 and 8.
The assembly of the rigid sheath and container 10 is apparent from
the above description. The complete operation of the container 10
in conjunction with the syringe 18 will be more clearly understood
from the following brief description of disassembly and use.
Assuming the syringe 20 to be prefilled and the needle assembly
positioned in its disarmed but frictionally engaged position shown
in FIG. 7, and the container to be assembled, disassembly is only
begun when the syringe is to be used. The cover 16 is removed
freeing the tabs 58 on the sheath 12. The operator may then with
one hand grasp the syringe barrel 20 and with the other hand pull
the sheath 12 upwardly driving shoulder 52 against flange 32,
piercing the seal 26 and thus arming the syringe 20. The retainer
14 may be slid downwardly over the sheath 12 and the syringe and
sheath placed on a table while the patient is prepared for the
medicament injection. During this time the tabs 58 prevent the
syringe from rolling. After preparation of the patient the sheath
12 is removed from the needle assembly and the syringe is ready for
medicament injection in accordance with conventional procedure.
* * * * *