Medical syringe abstract
Medical syringe containment in a telescoping leakproof two-piece
container for an individual medical syringe, especially as an inner
container enclosing a radiopharmaceutical-filled syringe, and being
enclosed in turn within a radiation-shielding outer container useful
for shipment to a use location, where the respective containers
are uncapped and the syringe is removed and used--whereupon the
used syringe is re-inserted into the inner container before recapping,
and the outer container is recapped about the recapped inner container
and contents, for shipment to a disposal or reclamation site.
Medical syringe claims
1. Containment method for medical syringes, especially for syringes
containing a radiopharmaceutical;
comprising the steps of
selecting a syringe having a thumb-actuatable plunger slidably
positioned partially within a syringe barrel having a lateral finger
grip at one of its ends, a needle junction at its opposite end,
and a needle extending from the junction and capped to preclude
inserting the syringe barrel needle-end first into the open upper
end of an upright tubular container body extending laterally and
upward at its open end configured to fit non-rotatively about the
syringe finger grip and otherwise long and wide enough to its closed
bottom end to surround the syringe barrel from the finger grip to
and past the needle; and
covering the syringe plunger with a tubular container cap open
at its bottom end and extending laterally and downward at its open
end configured to fit non-rotatively about the syringe finger grip
and otherwise long and wide enough to surround the syringe plunger
to the extent it protrudes above the barrel finger grip; and
assembling the cap and the body by telescoping their respective
open ends together, one within the other, and press-fitting them
in snugly contiguous relationship and so forming a leakproof container.
2. Containment method for the container assembled according to
claim 1 including the step of inserting said container as an inner
container into an outer radiation-shielding container as an outer
container, to protect the surroundings from radiation when the syringe
contains a radiopharmaceutical composition.
3. Containment method according to claim 2 including the step
of shipping a filled syringe enclosed in the inner container enclosed
in the radiation-shielding outer container to a usage destination
for radiopharmaceutical-residue syringes.
4. Containment method according to claim 3 including the step
of shipping the syringe after usage enclosed in the inner container
enclosed in the radiation-shielding outer container to a disposal
destination for the radiopharmaceutical-filled syringe.
5. Containment method according to claim 2 including the steps
of first shipping a filled syringe enclosed in the inner container
enclosed in the radiation-shielding outer container to a usage destination
for the radiopharmaceutical-filled syringe, and then shipping the
syringe, after usage, enclosed in the inner container enclosed in
the radiation-shielding outer container to a disposal destination
for radiopharmaceutical-residue syringes.
6. Containment method according to claim 5 including the steps
of uncapping both the inner container and the outer container, and
removing the syringe from the inner container while leaving the
body of the inner container within the body of the outer container.
7. Containment method according to claim 1 including the step
of preliminary providing one of the open ends of the inner container
with a detent adapted to overlap an adjacent part of the other end
of the inner container with an audible and tactile snap to deter
disassembly after the respective open ends are press-fit assembled.
8. Leakproof container produced by the method of claim 1.
9. Leakproof radiation-shielding composite container produced with
inner and outer containers by the method of claim 2.
10. Filled syringe packaged and shipped according to the method
of claim 3.
11. Used syringe packaged and shipped according to the method of
12. Syringe first packed and shipped filled, and then packed and
shipped used, all according to the method of claim 5.
13. Containment method according to claim 1 including the steps
of preliminarily providing at least one of the open ends of the
inner container with a slight taper relative to the other open end,
facilitating insertion of one open end into the other open end,
and assuring a mutually contiguous snugly leakproof relationship
of the ends when so assembled.
14. Containment method according to claim 10 including the step
of preliminarily providing one open end of the outer container with
a recess to receive the laterally extending portion of the inner
container about the similarly extending syringe finger grip, to
assure non-rotation of the containers relative to each other.
15. Containment method according to claim 1 including the preliminary
step of providing an open end of the inner container with a taper
relative to its other open end to aid in telescoping them contiguously
to form the resulting leakproof container.
16. Containment method according to claim 2 including the preliminary
step of configuring an inner part of the outer container to fit
non-rotatively about the inner container therewithin.
17. Assembly method comprising the following sequential steps:
selecting a syringe including a piston axially movable within a
cylindrical barrel, the barrel having a top end closed thereby,
a finger grip protruding transversely from the barrel top end, and
a bottom end tip fitted with a needle having a removable cover;
enclosing the syringe within an inner container including a lower
or body portion closed at its bottom end and individually open at
its top end, and an upper cap portion closed at its top end and
individually open at its bottom end, the respective individual open
ends fitting telescopically one within the other, together sealing
the inner container about the syringe, in non-rotative relationship
to the finger-grip protrusion from the barrel, and being retained
disengageably by a detent on one such body portion as so assembled;
enclosing the inner container, so assembled about the syringe,
within an outer container including a lower or body portion closed
at its bottom end and openable at its top end, and an upper cap
portion closed at its top end and openable at its bottom end, the
respective openable ends fitting one within the other in sealing
relationship around the inner container with the syringe inside,
one of the outer container body portions laterally fitting non-rotatively
about finger-grip protrusion of the inner container.
18. Method according to the method of claim 17 including the steps
of transporting a syringe containing radioactive material within
the assembled inner container, within the assembled outer container,
to a use location, disassembling the containers there to enable
manipulation of the syringe to dispense radioactive material, then
reassembling the inner container around the syringe, and then reassembling
the outer container around the inner container, and sending same
to a disposal site for syringe and inner container.
Medical syringe description
This invention relates to containment of medical syringes, and
concerns especially their safe shipment for use and for disposal,
especially such syringes with radiopharmaceutical contents/residues.
BACKGROUND OF THE INVENTION
Many or most medical syringes nowadays are intended for single
use only, and for disposal promptly thereafter, to guard against
the possibility of contaminating a subsequent patient or a health
care professional with the blood of any patient or with any residual
medication in the syringe. Where a medication comprises radioactive
material, special care must be taken to prevent not only leakage
of blood or medication liquid from the syringe but also exposure
of the surroundings to radiation.
Collective disposal of used syringes with their needles (and other
"sharps" such as scalpels and stitch cutters) is known,
as in U.S. Pat. Nos. to Haniff 4657139; and McCarthy 5273221.
The trend toward one-time usage is conducive to immediate individual
disposal, for which packages are known, as in Clanton 4979616
and in Yates et al. 5293616. Such one-syringe packages are bulkier
than those for new syringes, as in Windischman 4106622 and in
Cuu 4634428. Yet packaging of new syringes lacks provision for
syringe disposal, so a new package is not convertible to a disposal
package. Reich U.S. Pat. No. 5519931 teaches a two-part inner
container useful within an outer two-part radiation-shielding container
wherein (i) a filled syringe can be shipped along with the lower
part (only) of the inner container, (ii) the used syringe can be
reshipped after capping the inner container--which itself provides
Hence, a need exists for fluid leakproof disposal packages to hold
individual filled and used syringes, and a related need exists for
radiation shielding in the packaging of such syringes containing
radiopharmaceutical medications and, after use, their residues.
The present invention undertakes to meet these and related necessities.
SUMMARY OF THE INVENTION
A primary object of the present invention is to provide a fluid
leakproof package for an individual medical syringe.
Another object of this invention is to accommodate, lengthwise
in such package, a hypodermic syringe with a needle in place on
A further object of the invention is to accommodate, lengthwise
in such package, a plunger incompletely depressed into the barrel.
Yet another object of this invention is to provide a press-fit
telescoping snap-lock leakproof structure for such package.
A still further object of the invention is to simplify the shipment
of radiopharmaceutical compositions to a use location and from that
location after use, shielding the surroundings from radiation.
In general, the objects of the present invention are attained by
providing containers adapted to enclose a medical syringe, which
may contain a radiopharmaceutical, sufficiently securely to seal
off its contents, to protect the surroundings against fluid leakage
therefrom, both when shipped (filled) to a place of use, and then
when--with residual contents--likewise shipped to a disposal site.
For radiopharmaceutical medicaments, an inner container leakproof
to liquids and an outer container impervious to radiation are provided,
such that the filled syringe can be enclosed in the inner container
within the outer container, and the used syringe can be sent in
the inner container replaced in the outer container to a disposal
A preferred embodiment of this first or inner container has a two-piece
tubular structure providing a press-fit leakproof junction of the
open ends of the component pieces assembled by juxtaposition.
Further, this fluid leakproof container is adapted to be used in
combination with a surrounding radiation-shielding container, to
protect the surroundings from radiation contamination therefrom,
as whenever the filled syringe contains a radiopharmaceutical material.
The press-fit fluid leakproof inner container fits for shipment
within the radiation-shielding outer container, which may have a
twist-fit or equivalent closure.
Although reopenable manually under intentional extensive force,
such inner container will not reopen or leak liquid contents under
normal shipping or handling. Hence, it can protect the surroundings
from possible leakage from a filled syringe before use, as shipped
in filled condition, and from possible residue from a used syringe
as when shipped to a disposal site. Radiopharmaceutical contents
or residue are similarly secure and will not contaminate such an
outer radiation-shielding container (or "pig") in its
shipment either way.
Other objects of the present invention, together with means and
methods for accomplishing the various objects, will be apparent
from the following description and accompanying diagrams of a preferred
embodiment being presented by way of example rather than limitation.
SUMMARY OF THE DRAWINGS
FIG. 1 is a side elevation of a conventional (prior art) disposable
single-use medical syringe with attached needle, suitable for disposal
according to this invention, as in subsequent views;
FIG. 2 is a plan view of the syringe of FIG. 1 (prior art);
FIG. 3 is an exploded side elevation of tubular components of a
container of the present invention, open at adjacent ends but closed
at opposite ends, to press-fit together around syringe and needle;
FIG. 4 is a plan view of the container components of FIG. 3;
FIG. 5A is a transverse sectional detail (enlarged) of corner features
of a syringe container of this invention being assembled;
FIG. 5B is a transverse sectional detail (enlarged) of a second
corner feature of a fully assembled container of this invention;
FIG. 5C is a transverse sectional detail (enlarged) of a corner
feature partly similar to but partly different from that of FIG.
FIG. 6 is a side elevation of such a container, assembled from
the components of FIG. 3 by press-fitting their open ends into
fluid leakproof relationship about a syringe (and needle) of FIG.
FIG. 7 is an exploded side elevation of components of another container
(partly cut-away) useful along with the container of the preceding
views according to this invention, having open adjacent ends (opposite
ends closed) adapted, as by threading, to be twisted together and
so assembled around the the medical syringe container;
FIG. 8 is a transverse sectional elevation through a composite
container at the junction of the FIG. 7 components assembled around
the FIG. 6 container with the syringe of FIG. 1 inside;
FIG. 9 is a similar transverse sectional elevation through the
mid-part of a lower portion of the same composite container; and
FIG. 10 is a similar transverse sectional elevation through an
even lower part of the same resulting composite container.
FIG. 11 is a block diagram showing various operation steps in practicing
the method of this invention from beginning to end.
DESCRIPTION OF THE EMBODIED INVENTION
FIG. 1 shows, in side (or longitudinal) elevation, conventional
(PRIOR ART) disposable single-use medical syringe 1 with attached
needle 9 optionally surrounded by protective cover 10 (in phantom).
The syringe itself has two main members: cylindrical barrel 7 and
piston-like plunger 3 fitting slidably into the cylindrical barrel.
The barrel is open at its plunger-receiving end 5 where it flares
outward at opposite sides as finger-grip 6 and at its other end
is constricted to tip 8 (open), where protective cover 10 encloses
needle 9. The plunger is closed from its end 4 within the barrel
and shown here nearly fully inserted, to its flared round (thumb-actuated)
opposite exposed or top end 2.
A person holding such a conventional syringe can fill it wholly
or partially with medicating liquid by manually withdrawing the
plunger (partially) from the barrel with the (uncovered) needle
end immersed in the liquid, and contrariwise can dispense the liquid
from the syringe (after de-aerating it) via the needle by squeezing
thumb and fingers to depress the plunger further into the barrel.
A radiopharmaceutical should be given appropriate radiation-shielding.
Hence, a syringe usually would be filled with a radiopharmaceutical
by mechanical means rather than being filled manually. Any medical
personnel manipulating such a syringe should be radiation-shielded.
FIG. 2 shows, in top plan, thumb-actuated end 2 of the syringe
plunger, and finger-grip 6 (of the syringe barrel) protruding to
the right and left sides. Otherwise both the plunger and the barrel
are hidden behind or below that top end so are not visible in this
view. The finger-grip hexagonal outline appears as elliptically
FIG. 3 shows, in exploded side elevation, two-piece embodiment
11 of the syringe container of this invention, an"inner"
container. Upper tubular container member or"cap" 13 has
cylindrical upper portion 12 closed hatlike overhead, and has adjacent
tubular brim porton 14 (hexagonal plan) open downward. Lower tubular
container or "body" member 17 has, at upper end 15 similarly
outlined portion 16 open cuplike upward and open axially downward
to a long tubular housing portion terminating in closed bottom end
18. Open lower end portion 14 of cap 13 is so dimensioned to enable
it to be press-fit telescopically, contiguously, and snugly within
upper end portion 16 of housing 17 thereby providing the respective
tubular container members with a fluid leakproof junction.
FIG. 4 shows in plan, and FIG. 6 shows in side elevation, cap 13
and body 17 of container 11 as assembled. A generally hexagonal
outline of the upper end portion 16 of the body closely surrounds
slightly smaller similarly hexagonal lower end portion 14 of the
cap 13 which also surrounds circular top 12 from this vantage point.
FIGS. 5A, 5B, and 5C show fragmentarily, in enlarged transverse
section, and with wall thickness somewhat exaggerated, the corner
detail(s) at a junction of open ends of both cap and body. Assembly
of the container, as shown, depends upon telescoping of the close-fitting
open lower end of the cap within the open upper end of the container
body. Of course, if desired, the container parts could be resized
from the illustrated inner/outer cap/body relationship to put the
cap on the outside of the body, with like sealing effect, so long
as the adjacent walls of cap and body become snugly contiguous,
which provides the leakproof capability of the resulting container.
FIG. 5A shows downturned brim portion 14 of cap 13 entering (see
arrow) the upper part of overlapping inner wall surface of cupped
upper end portion 16 of body 17. It will be understood that the
illustrated snugly contiguous relationship exists completely around
the vertical axis of the cap and the body of this container. The
downturned entering end is dimensioned to enter the upturned receiving
end and to tighten therein, as both surfaces yield a bit until fully
assembled. To assure leakproof contiguity of the wall surfaces while
maintaining ready press-fit assembling of such open ends when they
are juxtaposed, the entering end (here, the cap brim) may be tapered
slightly inward (e.g., angle B as much as several degrees less than
90.degree.) and/or the receiving end (here, the body top) may be
tapered slightly outward (e.g., angle A as much as several degrees
more than 90.degree.). In fact, both angles might actually depart
from a right angle in the same direction, so long as they differ
at most about several degrees from one another in relative orientation.
FIGS. 5B and 5C show two arrangements of detent means effective
to retain the assembled container in its fully assembled condition,
as distinct from the leakproof characteristic--also present here.
(Reference characters similar to those in FIG. 5A are single-primed
in FIG. 5B, and double-primed in FIG. 5C, to denote alternatives.)
Both embodiments are effective to keep the container securely closed
once fully assembled. Yet it may be safely disassembled manually
(pulled apart) by applying an extensive force to the respective
end portions, just enough for them to flex or yield enough to restore
the container to its separate original upper and lower members.
Suitable polymeric compositions for the container are noted below.
FIG. 5B shows ridgelike detent R protruding from a portion of the
inner edge of the cupped upturned end of top portion (here 16')
of the body just above and overlapping the external shoulder corner
of the downturned brim (here 14') of the cap. It will be understood
that such overlapping secures the cap and housing together unless
the resulting container is forcibly pulled apart, as by a person.
FIG. 5C is a similar view where the top body portion (here 16")
engages complementary indentation or groove G optionally present
in the corner of the brim shoulder portion (here 14") of the
During assembly, a noticeable audible and tactile "snap"
occurs as ridge R passes the brim corner, whether groove G is present
there or not. Later disassembly whether unintentional or intentional,
is deterred, although (as already indicated) remaining quite possible.
A detent (such as R)--and, when present, an indentation (such as
G)--for receiving the detent--should occupy only a relatively minor
part of the peripheral extent of the mating surfaces to enable convenient
assembling (and disassembling) of this inner container. Preferably
a pair of detents are used, one along the center third of each inside
top edge of the furthest off-axial upturned narrow ends.
FIG. 6 shows in side elevation (reduced scale) fluid leakproof
container 11 assembled from the FIG. 3 members by press-fitting
the open end of cap 13 into fluid leak-proof relation, within the
open end of body 17. The assembled container is understood here
to be enclosing a syringe (and needle) of FIG. 1. Further enhanced
protection may be obtained, as by enclosing container 11 as an inner
container within an outer container, to form a composite container
effective to shield the surroundings from radiation contamination
as well as to preclude leakage of residual fluid.
FIG. 7 shows, in longitudinally exploded side elevation (on a like
scale), a two-piece radiation-shielding container embodiment having
cap 23 as its upper tubular member, and body 21 as its lower tubular
member. Plastic outer skin layer 20 covers metallic (lead) radiation-shielding
inner layer (uniformely shaded). The cap has sombrero-shaped top
portion 22 opening downward within enlarged brim portion 24 whose
metallic internal perimeter 24' is threaded.
Body 21 has plastic outer skin 29 including, at its open upper
end 25 portion 29' externally threaded complementarily to the open
internally threaded overlying cap. The metallic inner part of the
body opens axially downward into long tubular portion 27 tapering
to closed bottom end 28. When threaded together, the cap and body
fit snugly and provide a radiation-shielding container--well adapted
to holding an inner container shaped to accommodate the finger-grip
portion of a syringe. As orienting the syringe finger-grip to fit
into the hexagonal open end of the inner container assures secure
assembly of that container, orienting the hexagonal outline of the
inner container to fit into the receptive recess in the body of
the outer container assures secure assembly of the outer container.
FIGS. 8 9 and 10 show, in fragmentary transverse section at several
levels, the composite container of this invention assembled on the
outer (FIG. 7) container, enclosing the inner (FIG. 6) container,
itself holding the FIG. 1 syringe (whether filled or used).
FIG. 8 shows through the outer container junction (from outside
in) cap (23) skin layer 20 threaded inner wall 24', in mesh with
threaded part 29' of body (21) skin layer 29. Recess 36 in body
layer 27 of inner container (11) is hexagonal and accommodates similar
horizontal portion 16 of the body of the inner container. The inner
container is sectioned here just below the finger grip (not shown)
of enclosed syringe barrel 7 and plunger 3 (both shown).
FIG. 9 shows a corresponding sequence of features through the mid-part
of the same resulting composite container and its contents. Here
the similarly directed sequence lacks the outer parts in FIG. 8
but shows skin 29 and body 27 of lower wall member 21 of the outer
container, then the lower wall of inner container member 17 and
finally cylindrical barrel 7 and plunger 3 of the syringe.
FIG. 10 resembles FIG. 9 at smaller diameter, and with needle 9
substituted for the syringe elements now above the plane of view.
FIG. 11 is a block diagram of the nature and the order of steps
preferred according to the present invention. It renders operational
aspects of this invention even more apparent--given the specified
inner and outer containers or their equivalent(s). Preliminarily
essential (at top of leftmost of two columns) is FILL SYRINGE WITH
RADIOPHARMACEUTICAL THEN CAP THE NEEDLE, as medicament customarily
is drawn in through the immersed needle by withdrawing the plunger
far enough to fill the syringe with the intended quantity thereof.
Next INSERT FULL SYRINGE INTO BODY OF INNER CONTAINER AND THEN CAP
INNER CONTAINER. A syringe filled with a non-radioactive medicament
could be shipped in the so-called "inner" container, alone
or with others suitably wrapped, but when filled with a radiopharmaceutical,
syringes are shipped individually and in a radiation-shielding (here
called simply "outer") container. The final pre-shipment
step is WITH FILLED INNER CONTAINER IN BODY OF OUTER CONTAINER,
CAP OUTER CONTAINER. Then SHIP TO USAGE SITE as indicated by arrows
leading to the top of the rightmost or second of the block diagram
According to FIG. 11 the first block at the usage site reads UNCAP
OUTER CONTAINER, UNCAP INNER CONTAINER, REMOVE & USE SYRINGE.
Of course, a syringe containing a radiopharmaceutical is manipulated
with special care in use. Similarly, its disposal demands special
handling and shipment, as the used syringe may properly contain
a radioactive residue. Hence, INSERT USED SYRINGE INTO BODY OF INNER
CONTAINER AND RECAP THE INNER CONTAINER rendering it leakproof here.
As the inner container body may have been left in the outer container
body, or may have been removed preparatory to syringe usage, the
next block reads WITH REFILLED INNER CONTAINER IN BODY OR OUTER
CONTAINER RECAP THE OUTER CONTAINER. Finally SHIP TO DISPOSAL SITE,
where proper steps can be taken to recover whatever is worth reusing
and to destroy or reprocess appropriately whatever is recoverable.
No unusual materials of construction are required. The syringe
may be made of organic polymeric material (plastic) or even glass,
or the plunger may be made of one such composition, and the barrel
be made of another such composition. The syringe inner container
may be made of polyalkylene, polycarbonate, or like composition
from the textile and plastic film arts. The outer container's ability
to shield the surroundings from radiation contamination is a function
of mass, so it is preferably mainly lead, and thick enough to meet
radiation health and safety standards, usually covered by plastic.
Instead of threaded turns as in the illustrated embodiment of outer
container, an equivalent twist-fit junction (not shown) may have
one member's transverse end surface vertically slotted and ramped
to admit two or more evenly spaced balls on respective stems extending
from the opposite member's like end surface, enabling the ends to
be drawn together with a simple partial turn.
Advantages and benefits of practicing the present invention in
its various aspects have been stated above and doubtless will become
most apparent to those persons who actually undertake its practice.
Included should be the following, (i) a leakproof inner container,
(ii) with a snap-lock closure precluding accidental reopening but
enabling safe handling and intentional manual reopening, (iii) a
radiation-shielding outer container receptive to the inner container
properly assembled, (iv) shippable to and (v) manually reopenable
at a use location; and, after usage to dispense contained medicament,
(iv) the syringe is readily replaceable in the still leakproof inner
container, (v) which is readily replaceable in the outer container,
for (vi) safe shipment to a disposal/reclamation site, where (vii)
the outer container may be reclaimed and the rest including residual
blood or other bodily fluids be appropriately destroyed or otherwise
disposed of according to accepted safe practices.
Other benefits are uniform and systematic handling of new, or filled,
and later used medical syringes, and the resulting savings, not
least a reduction in costs of dealing with (or insuring against)
possible economic consequences of personal encounters with harmful
syringes and their residues through negligent handling or otherwise.
Preferred embodiments and variants have been suggested for this
invention. Other modifications may be made, as by adding, combining,
deleting, or subdividing compositions, parts, or steps, while retaining
all or some of the advantages and benefits of the present invention--which
itself is defined in the following claims.