U.S. patent number 3,828,775 [Application Number 05/157,744] was granted by the patent office on 1974-08-13 for self-packaged hypodermic syringe.
This patent grant is currently assigned to Iso Nuclear Corp.. Invention is credited to Jack Armel.
United States Patent |
3,828,775 |
Armel |
August 13, 1974 |
SELF-PACKAGED HYPODERMIC SYRINGE
Abstract
The invention contemplates a self-packaged hypodermic syringe
wherein the body of the syringe is itself an important part of the
package. Removable end seals complete the packaged article and
respectively provide actuating access to the plunger at the rear
end, and to the needle at the forward end. As long as the syringe
is stored, the needle is in a retracted position, protected against
mechanical abuse or contact; upon plunger actuation, the needle is
displaced to its forwardly projected position, in readiness for
use. In the preferred forms which are described, the syringe body
and the seal or closure structures are of a suitable plastic,
shaped for localized frangibility when exposed to gamma irradiation
of such dosage as to achieve sterility of the entire contents of
the sealed structure.
Inventors: |
Armel; Jack (New York, NY) |
Assignee: |
Iso Nuclear Corp. (Ballston
Spa, NY)
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Family
ID: |
26854448 |
Appl.
No.: |
05/157,744 |
Filed: |
June 28, 1971 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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797095 |
Feb 6, 1969 |
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Current U.S.
Class: |
604/196;
604/200 |
Current CPC
Class: |
A61M
5/002 (20130101); A61M 5/178 (20130101); A61M
2005/312 (20130101); A61M 2005/3121 (20130101); A61M
5/3202 (20130101) |
Current International
Class: |
A61M
5/00 (20060101); A61M 5/178 (20060101); A61M
5/31 (20060101); A61m 005/32 () |
Field of
Search: |
;128/215,216,218R,218N,218D,122D,220 ;206/622R,622A,63.3 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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66,437 |
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Oct 1956 |
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FR |
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330,586 |
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Aug 1903 |
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FR |
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897,996 |
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Jun 1944 |
|
FR |
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1,081,785 |
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Jun 1954 |
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FR |
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Primary Examiner: Beich; Joseph S.
Attorney, Agent or Firm: Sandoe, Hopgood & Calimafde
Parent Case Text
This application is a continuation of copending application Ser.
No. 797,095, filed Feb. 6, 1969, now abandoned.
Claims
I claim:
1. A self-packaged hypodermic syringe, comprising an elongated
tubular body having means providing a continuous bore that is open
at a rear end and substantially closed at the other end, said
closed end including an axially outwardly extending neck having
means providing a relatively reduced elongated bore, first
removable means closing the open end of the reduced bore means,
piston means having a position spaced a predetermined distance from
the closed end of said body and having guided support in the
continuous bore means, said piston means including a stem extending
rearwardly beyond the open end of the continuous bore means to at
least the extent of said predetermined distance and including a
flange of radial extent exceeding that of the continuous bore
means, an elongated needle having its forward end positioned within
the reduced bore means, piloting means positioned by the continuous
bore means and forwardly of the piston means for centrally
supporting the rearward end of said needle, second removable means
including a frangible portion peripherally continuously connected
to said flange and body at the rear end of the continuous bore
means and effectively encapsulating the rearwardly projecting end
of said stem, whereby upon removing said first and second removable
means, said stem may be actuated to axially drive said piston and
needle to a forward position in which said needle projects beyond
the neck of said body, in readiness for use.
2. A self-packaged hypodermic syringe, comprising an elongated
tubular body having continuous bore means that is open at a rear
end and substantially closed at the other end; said closed end
having means providing a relatively reduced central elongated bore
closed near an end thereof, an elongated needle adapted to be
centrally and slidably supported by and within said bore means, a
piston movably guided within said continuous bore means and
positioned rearwardly of the needle and having a stem projecting
rearwardly beyond the rear end of said continuous bore means, said
stem including a radially outwardly extending peripheral flange at
its rearwardly projecting end, and a hermetically sealed enveloping
enclosure for the rear end of said stem and peripherally
continuously connecting said flange to said body; said body and
said envelope being of a plastic material for which, at a
sufficiently thin section and for a predetermined gamma-radiation
exposure, the stress necessary to effect rupture at the thin
section will be reduced, such exposure being adequate to achieve
desired sterilization within said body; said body being formed with
a first such localized thin section near the closed end of the
reduced bore means, said envelope having a circumferentially
extending localized groove establishing a second such thin section,
and the remainder of the body being formed with a material
thickness which exceeds that at either of said thin sections;
whereby upon subjection of said syringe to such predetermined
gamma-radiation exposure, the syringe and its contents will be
sterilized and the stress necessary to effect rupture at the thin
sections will have been reduced.
3. The syringe of claim 1, in which said first-mentioned removable
means comprises a frangible diaphragm closing the reduced bore
means.
4. The syringe of claim 1, in which said neck includes means
providing a counterbore intermediate the continuous bore means and
the reduced bore means, and in which said piloting means for said
needle includes an axially elongated hub supporting said needle and
engageable in said counterbore means when in full-forward
position.
5. The syringe of claim 4, in which further central supporting
means for said needle is in slidable contact with said continuous
bore means and in which said body and said further central
supporting means include interlocking means positioned for
engagement at a full-forward position of said central supporting
means adjacent said neck.
6. The syringe of claim 5, in which said interlocking means
includes an elongated ramp detent formed radially inwardly in the
continuous bore means near the forward end thereof, said ramp
terminating in a locking shoulder.
7. The syringe of claim 6, in which said ramp detent is one of a
plurality of like detents formed at angularly spaced locations in
the continuous bore means.
8. The syringe of claim 2, in which said circumferentially
extending groove is at substantially one radial-plane location.
Description
According to present techniques, hypodermic syringes require
individual containers to assure sterility, and special packaging is
required to permit sterilization by gas. To assure sterility, the
packaging must be permeable to gas and, therefore, the package is
generally flimsy and may easily be ruptured after gas
sterilization, thus destroying its sterile condition. A
hermetically sealed container made of durable and puncture-proof
material, usually plastic, can be sterilized by gamma radiation.
Moreover, the bulk now involved in using individual outer
containers represents an undesirable limitation on loading density,
should it be desired to sterilize through gamma irradiation.
It is accordingly an object of the invention to provide an improved
syringe and package construction.
It is another object to provide a construction meeting the above
object and substantially reducing the handling costs, while
assuring the highest standards of sterility in the packaged
article.
It is a specific object to achieve the foregoing objects with a
construction and method which provide positive assurance of initial
sterility and which prevent any further bacterial contamination
from the outside environment.
Still another object is to achieve the foreoing objects without
need for further packaging the individual item, as in an envelope,
box or tube.
It is also an object to provide an improved hypodermic-syringe
construction which permits storing the needle in a fully retracted
and protected position until ready for use.
It is a specific object to achieve the immediately preceding object
with a construction in which the needle, when projected for use, is
automatically locked and positively referenced to the body of the
syringe.
A still further object is to meet the above objects with a
construction in which greater packing density is achievable than at
present, thus enabling a larger number of units to be
gamma-sterilized, per unit volume of space, and thus also providing
storage convenience.
A general object is to achieve the highest quality sterile product,
at reduced cost of manufacture, and inherently lending itself to
the further saving of cost in sterilizing, storage, and
shipping.
Other objects and various further features of novelty and invention
will be pointed out or will occur to those skilled in the art from
a reading of the following specification, in conjunction with the
accompanying drawings. In said drawings, which show, for
illustrative purposes only, preferred forms of the invention:
FIG. 1 is a longitudinal sectional view of a self-packaged syringe
of the invention, shown fully sealed, as for storage;
FIG. 2 is a view similar to FIG. 1, but with the self-stored needle
projected in readiness for taking-on an injection charge;
FIG. 3 is another similar view, to show the plunger or piston fully
retracted, as after the injection charge has been loaded into the
syringe; and
FIGS. 4, 5 and 6 are views similar to FIGS. 1, 2 and 3,
respectively, to show similar manipulations for an alternative
construction.
Briefly stated, the invention contemplates a self-packaged
hypodermic syringe wherein the body of the syringe is itself an
important part of the package. Removable end seals complete the
packaged article and respectively provide actuating access to the
plunger at the rear end, and to the needle at the forward end. As
long as the syringe is stored, the needle is in a retracted
position, protected against mechanical abuse or contact; upon
plunger actuation, the needle is displaced to its forwardly
projected position, in readiness for use. In the preferred forms
which are described, the syringe body and the seal or closure
structures are of a suitable plastic, shaped for localized
frangibility the same being exposed to gamma irradiation of such
dosage as to achieve sterility of the entire contents of the sealed
structure.
Referring to FIGS. 1 to 3 of the drawings, the invention is shown
in application to a self-packaged, sterilized, hypodermic syringe
comprising an elongated tubular body 10 having a barrel 11 with a
continuous bore 12 which is open at the rear or actuating end, and
which is substantially closed at the forward or injection end.
Substantial closure is achieved at an integral forwardly projecting
neck 13, connected to the barrel 11 by a tapering or frusto-conical
wall 14. The neck 13 has an elongated reduced bore 15 to
substantially reduced diameter, sized to accommodate and centrally
support a hypodermic needle 16. Initially, and while my device
remains self-packaged, the forward end of the neck passage 15 is
fully closed, as by the integral formation of an enlarged clsoure
head or knob 17. This closure 17 is severable from the rest of the
body 10 and neck 13 at a frangible section 18, denoted by a
circumferential groove around the reduced forward portion 19 of the
neck 13.
In accordance with a feature of the invention, the needle 16 is
formed as part of a retracted subassembly which includes a support
or piloting structure 20, deriving, from the larger bore 12,
central guided support for the rear end of needle 16. In the form
shown, the piloting structure comprises a dished frusto-conical
element 21 riding bore 12 and including a central, forwardly
projecting hub or boss 22 for the firmly bonded and well-rooted
attachment of the rear end of needle 16. Preferably, the conical
tapers at 14-21 match one another, and a counterbore 23 in the root
end of the reduced bore 15 is sized ultimately to receive boss 22
with a snug fit.
A plunger assembly 25 includes a piston 26 having liquid-sealing,
guided engagement with the continuous bore 12, and an elongated
stem which, in the self-packaged position shown in FIG. 1, projects
rearwardly of body 10 at least substantially to the extent that
piston 26 is spaced from the closed end of the body. Piston 26 is
shown with a short, central, forwardly projecting boss 27 for
abutment with the base of dished element 21. Piston 26 may be
formed integrally with the rearwardly extending stem structure but
it is preferably a separate element, having the desired
contour-conforming local resilience to achieve liquid-sealing
engagement with bore 12. As a separate element, piston 26 is thus
seen as essentially a button which may have snap-fitted or detent
engagement with a suitable formation at the forward end of the
stem; details of such a connected-relationship form no part of the
claimed invention and are therefore not shown.
In the preferred form shown, the stem pilots on bore 12 throughout
its overlap therewith, and it is structured to conserve the plastic
material of which it is made. The stem comprises plural angularly
spaced elongated radial blades 28-29-30, integrally contiguous on
the plunger axis and deriving outer-edge support from bore 12. A
front disc 31 and a rear disc 32 are integrally formed with blades
28-29-30, as are appropriately spaced reinforcing sector members,
as at 33-34. Preferably, the rear disc 32 is radially enlarged to
exceed the bore 12, for ease of thumb manipulation.
In accordance with another feature of the invention, the rearwardly
projecting end of the stem is sealed to the body 10 when in
self-packaged condition. This may be achieved by dipping the rear
end of body 10 and the rearwardly projecting end of the stem into a
bath of liquid plastic which does not adhere to the stem material,
and by allowing a plastic coat to harden to form a continuous
protecting skin or sheath that is hermetically sealed to the rear
end of body 10; such a sheath may be readily removed when desired,
by rip-strip techniques known in the art. However, I prefer to
employ a cupped or envelope enclosure for the rearward projecting
stem and that the continuous hermetically sealed connection thereof
to body 10 shall include a frangible element to make the envelope
removable, when desired.
In the form of FIG. 1, the stem enclosure is afforded by a cup 35
circumferentially secured, as by known heat-sealing techniques, to
the rear or open end of the body 10. As shown, body 10 terminates
in a radially outward flange 36, for ultimate ease of manual
actuation of the syringe. Flange 36 also affords a convenient means
of positioning the open end of the envelope or cup 35, as by
overlap with a circular positioning ring or ridge 37 formed
integrally with flange 36. A short outward flange 39 on cup 35
abuts body flange 36 and facilitates circumferential application of
axial squeezing pressure during the heat-sealing process. The
frangible section of cup 35 is indicated at a circumferential
groove 38 near the location of body attachment, whereby the
thickness of cup material at this location is materially reduced,
as discussed above for the frangible section 18 at the other end of
the device.
In accordance with the invention, the plastic material for the body
10 and for the envelope 35 is selected, as from the polypropylenes,
and the reduced thickness at 18 and 38 is selected for locally
enhanced frangibility at 18 and 38, the sealed syringe and envelope
being exposed to a sterilizing dose of gamma radiation. Stated in
other words, the stress necessary to effect rupture at the
relatively thin portions (18-38) is reduced as a result of gamma
radiation sufficient to provide sterilization. The complete
self-packaged device will thereafter remain hermetically sealed, in
sterile condition, regardless of outside contaminating
environments.
When use is desired, the frangible sections 18 and 38 are simply
severed. At 18, a manually applied side thrust of knob 17, with the
thumb applied at 18, is operative to develop rupture stress to
sever the neck at 18 and thus to open the reduced passage 15. At
38, a manual squeeze applied to any diameter at the central region
of envelope 35 will develop rupture stress to at least partially,
if not completely, sever the envelope from the body, at 38. Local
squeezing at angularly displaced locations is thereafter effective
to complete the removal of the envelope 35.
Having severed the removable closures 17-35, the syringe is then
grasped, at 36 by two fingers of one hand (diametrically spanning
the body 10), and at 32 by applying thumb pressure. Such pressure
advances the plunger and the needle subassembly to the full-forward
position shown in FIG. 2, at which point the skirt 21 of the
needle-piloting subassembly has entered into locked
one-way-engaging relation with plural angularly spaced ridges or
ribs 40 formed in the continuous bore 12 of the body. The ridges 40
are shown as gentle ramps rising from the bore 12, in the radially
inward direction and in the forward direction; ridges 40 terminate
at an abrupt wall to establish a locking hold on the skirt 21 as it
clears the ends of the locking ramps. At this full forward position
(FIG. 2) the boss 22 is snugly fitted into the counterbore 23, thus
establishing a firmly rooted and locked support for the needle 16,
which is now fully forward and in readiness for use. Thereafter,
operation of the syringe is conventional, by submerging the exposed
needle in any serum or other liquid to be injected, while
withdrawing the plunger in order to fill the body 10. Such
withdrawn or fully loaded condition involves the relation of parts
illustrated in FIG. 3. Once the desired injection has been made,
the entire assembly may be discarded.
In the embodiment of FIGS. 4 to 6 many of the same parts will be
recognized from FIGS. 1 to 3, and therefore the same reference
numerals have been employed, but with primed notation. The
embodiments of FIGS. 4 to 6 merely illustrate alternative provision
of frangible closures for the respective ends of the self-packaged
syringe.
Referring to FIG. 4, closure of the reduced passage 15' for the
retracted needle 16' is effected at a diaphragm 50 formed
integrally with the body 10', and of such substantially reduced
thickness as to exhibit the brittle characteristics discussed above
in connection with the grooves 18-38.
FIG. 4 further illustrates alternative provision of the removable
enclosure for the rearwardly extending end of the stem of the
plunger. For this purpose, the closing envelope 35' may be cut from
straight tubular material, and the body flange 36' and diameter of
thumb piece 32' sized to the same circumferential proportions,
whereby the tube 35' may be overlapped with both of members 32' and
36'; alternatively, as shown, the closing envelope 35' may be of
cup-shape, sized at its open end for overlap with flange 36', the
thumb piece 32' being the bottom of the cup shape. Circumferential
sealing is accomplished at the axial overlap of these members, and
the package is thus effectively closed and hermetically sealed.
Circumferential grooves, at 51 near the body flange 36' and at 52
near the thumb piece 32', establish frangible sections in the
manner discussed above in connection with the groove 38 that the
desired local embrittlement is again the result of design of
reduced section thickness at 51-52, for the particular plastic
material and for the gamma-radiation dosage required to establish
sterility of the contents.
In use, a squeeze of the central region of the envelope 35' is
adequate to sever the frangible sections 51-52. Such parting may be
facilitated by additionally providing one or more elongated
generally longitudinal grooves as suggested at 53 (between grooves
51-52) in the envelope 35' so that upon circumferential severance
at 51-52, the circumferential continuity of envelope 35' may also
be broken, and the broken material removed, freeing the plunger for
use. The plunger may then be forwardly projected to break the
diaphgram 50 and establish the needle 16 in its locked firmly
positioned forward position. Thereafter, operation is as described
for FIGS. 1 to 3.
It will be seen that I have described an improved hypodermic
syringe construction meeting all the above-stated objectives and
having a number of important advantages over present constructions,
particularly when viewed in the context of the problems of sealing,
storing and shipping the device. My construction has eliminated
both the need for use of a separate package, and the need for
employment of any particular sterilizing precautions during the
assembly of parts. The parts are not brittle during the mechanical
assembly operations and, therefore, no particular limitations for
careful handling by automated machinery are necessary.
Embrittlement only occurs as a final step at the time when the
fully sealed package is being also sterilized by the radiation
dose. Finally, since the need for a separate container has been
eliminated, the only size limitation created by my construction is
that required for convenient manual manipulation of the syringe
body itself. It is thus possible to accumulate a greater density of
sealed syringes within the given unit volume, thereby optimizing
the loading density within a given irradiation facility.
As intimated in the remarks above, the invention lends itself to
inexpensive mass-production, affording a sterile instrument at
minimum cost. In this connection, all parts except the needle
itself may be of injection-molded plastic, formed, for example, in
multiple-cavity molds in accordance with present technology.
While the invention has been described in connection with the
preferred method and forms shown, it will be understood that
modifications may be made without departing from the scope of the
invention, as defined in the claims.
* * * * *