Safety syringe abstract
A safety syringe comprising a casing having a neck and a plunger
having a distal portion, a weak portion, and a coupling portion
covered by a hollow stopper having a membrane. The plunger is channeled
in the casing and is moveable between an extended position and a
compressed position. A needle holder, in the neck, contains a distally
facing arrowhead and a proximally facing needle. Moving the plunger
from an extended position to a compressed position, causes the arrowhead
to puncture the membrane and engage the coupling portion. If the
plunger is returned to the extended position, the needle is drawn
into the casing and the distal portion of the plunger can be removed.
If the plunger is re-compressed, the needle encounters a wall in
the neck preventing the needle from exiting the casing. The syringe
is easy to manufacture and prevents manufacturing burrs from being
injected into patients.
Safety syringe claims
We claim:
1. A safety syringe comprising: a syringe barrel; a needle holder
sealingly installed onto a front end of the syringe barrel, the
needle holder having an arrowhead at a rear portion thereof; a needle
sleeved onto the needle holder; a plunger having an coupling portion
dimensioned to engage the arrowhead, the plunger moveable between
an extended position and an compressed position at which an injection
is completed; and a cylindrical rubber stopper, having a membrane
at one end and a bore at the other end, is coupled to the plunger;
wherein the rubber stopper and the plunger are sequentially installed
into the syringe barrel, wherein the arrowhead has a circumferential
groove disposed at a base of the arrowhead, wherein the rubber stopper
is hollow and sleeved over the coupling portion, wherein the membrane
end of the rubber stopper faces the arrowhead, wherein at the completion
of the injection, the arrowhead pierces the membrane and engages
the coupling portion, and wherein when the plunger is drawn backwards
towards the extended position after the engagement of the arrowhead
and the plunger coupling portion, the needle holder and the needle
are drawn into the syringe barrel.
2. The syringe according to claim 1 further comprising: an inner
sealing channel on an internal side of the front end of the syringe
barrel; and a sealing ring sleeved onto the needle holder and dimensioned
to match the inner sealing channel,
wherein a rear portion of the inner sealing channel has a smaller
arc than an arc of the sealing ring, wherein a frontal portion of
the inner sealing channel has an inclined face having an arc larger
than the arc of the rear portion, wherein the needle holder is slideably
engaged in the front end of the syringe barrel by means of the sealing
ring, and wherein the needle holder can move in the direction of
the syringe barrel when the plunger is withdrawn after engagement
of the arrowhead and coupling portion.
3. The syringe according to claim 1 wherein a plane forming the
base of the arrowhead is not perpendicular to a central axis of
the syringe barrel, wherein after the needle is drawn into the syringe
barrel, an axis of the needle is directed toward an inner wall of
the syringe barrel, and wherein a subsequent re-compression of the
plunger toward the compressed position causes the needle to abut
the inner wall of the syringe barrel.
4. The syringe according to claim 1 wherein said plunger comprises
a weak portion and a resistance plate fixedly connected to the coupling
portion, wherein said plunger has a "+" shape comprised
of a vertical rib plate and a horizontal cross rib plate, wherein
the vertical rib plate is weakly connected to the resistance plate
by means of a plurality of tines, and wherein after completion of
the injection and after the needle holder and needle are drawn into
the syringe barrel, the weak portion can be broken upon application
of a bending moment.
5. The syringe according to claim 4 further comprising: a safety
mechanism having a wing plate, a check plate, and a flexible film
connecting the wing plate and the check plate, wherein the safety
mechanism is positioned on an exterior surface of the syringe barrel
at a position proximate to an insertion bore into which the plunger
is inserted, wherein one rib of said vertical rib plate has a groove,
wherein the check plate has a groove, wherein the groove of the
check plate and the groove of the vertical rib plate may be engaged
if the check plate is rotated toward the vertical rib plate by means
of the flexible film, and wherein if the groove of the check plate
and the groove of the vertical rib plate are engaged, premature
completion of the injection is prevented.
6. A safety syringe comprising: a syringe casing having a distal
end and a proximal end; a plunger channeled in the syringe casing
and moveable from an extended position to a compressed position,
wherein the plunger has a weak portion, a distal portion, and a
coupling portion comprising a plurality of hooks; a stopper having
a membrane, wherein the stopper is affixed to the coupling portion
of the plunger, and wherein the membrane is between the proximal
end of the syringe casing and the plunger; a needle holder initially
coupled to the proximal end of the syringe casing; a distally facing
arrowhead attached to a distal end of the needle holder; a proximally
facing needle attached to a proximal end of the needle holder, wherein
when the plunger is moved from the extended position to the compressed
position, the arrowhead punctures the membrane and lockingly engages
each of the hooks of the coupling portion of the plunger, and wherein
when the plunger is returned to the extended position after engagement
of the arrowhead and coupling portion, the needle holder and needle
are drawn into an interior of the syringe casing.
7. The syringe according to claim 6 further comprising: a plurality
of o-rings formed on an outer surface of the stopper, wherein the
plurality of o-rings frictionally engage an inner surface of the
syringe casing when the plunger is moved between the extended position
and the compressed position.
8. The syringe according to claim 6 wherein the proximal end of
the syringe casing comprises a cylindrical neck portion which houses
the needle holder.
9. The syringe according to claim 6 wherein the weak part of the
plunger includes a plurality of tines.
10. The syringe according to claim 9 wherein when the plunger
is returned to the extended position from the compressed position,
the distal portion of the plunger may be disengaged from the weak
portion by breaking the tines.
11. A safety syringe comprising: a syringe casing having a distal
end and a proximal end; a plunger channeled in the syringe casing
and moveable from an extended position to a compressed position,
wherein the plunger has a weak portion, a distal portion, and a
coupling portion; a stopper having a membrane, wherein the stopper
is affixed to the coupling portion of the plunger, and wherein the
membrane is between the proximal end of the syringe casing and the
plunger; a needle holder initially coupled to the proximal end of
the syringe casing; a distally facing arrowhead attached to a distal
end of the needle holder; and a proximally facing needle attached
to a proximal end of the needle holder, wherein when the plunger
is moved from the extended position to the compressed position,
the arrowhead punctures the membrane and lockingly engages the coupling
portion of the plunger, wherein when the plunger is returned to
the extended position after engagement of the arrowhead and coupling
portion, the needle holder and needle are drawn into an interior
of the syringe casing, wherein the proximal end of the syringe casing
comprises a cylindrical neck portion which houses the needle holder,
wherein the cylindrical neck portion comprises a circumferential
channel formed on an inner surface thereof, and wherein the needle
holder comprises a circumferential o-ring on an outer surface thereof
which is sized to substantially fill the channel.
12. The syringe according to claim 11 further comprising: a plurality
of o-rings formed on an outer surface of the stopper, wherein the
plurality of o-rings formed on the outer surface of the stopper
frictionally engage an inner surface of the syringe casing when
the plunger is moved between the extended position and the compressed
position.
13. The syringe according to claim 11 wherein the stopper substantially
covers the coupling portion of the plunger when the plunger is in
the extended position, and wherein the stopper substantially covers
the arrowhead and the coupling portion when the plunger is in the
compressed position.
14. The syringe according to claim 11 wherein the needle has a
longitudinal axis, wherein the syringe casing has a longitudinal
axis, wherein before engagement of the arrowhead and the coupling
portion, the needle axis and the syringe casing axis are substantially
parallel, and wherein after engagement of the arrowhead and the
coupling portion and after the needle holder and the needle are
drawn into the interior of the syringe casing, a mechanism alters
the orientation of the needle axis with respect to the syringe axis
so that they are not substantially parallel.
15. The syringe according to claim 14 wherein the proximal end
of the syringe casing comprises a cylindrical neck portion which
houses the needle holder, wherein a circumferential wall extends
from an interior end of the cylindrical neck portion to an outer
surface of the proximal end of syringe casing, and wherein the needle
will contact the wall if the plunger is moved toward the compressed
position.
16. A safety syringe comprising: a syringe casing having a distal
end and a proximal end; a plunger channeled in the syringe casing
and moveable from an extended position to a compressed position,
wherein the plunger has a weak portion, a distal portion, and a
coupling portion; a stopper having a membrane, wherein the stopper
is affixed to the coupling portion of the plunger, and wherein the
membrane is between the proximal end of the syringe casing and the
plunger; a needle holder initially coupled to the proximal end of
the syringe casing; a distally facing arrowhead attached to a distal
end of the needle holder; a proximally facing needle attached to
a proximal end of the needle holder; a safety mechanism comprising
a check plate affixed to an outer surface of the syringe casing,
the check plate adapted to move from an unlocked position to a locked
position; and a notch in a side of the distal portion of the plunger,
wherein when the plunger is moved from the extended position to
the compressed position, the arrowhead punctures the membrane and
lockingly engages the coupling portion of the plunger, wherein when
the plunger is returned to the extended position after engagement
of the arrowhead and coupling portion, the needle holder and needle
are drawn into an interior of the syringe casing, and wherein when
the check plate is in the locked position, it engages the notch
thereby preventing the plunger from moving from the extended position
to the compressed position.
17. A method of preventing reuse of a syringe including a syringe
casing having a longitudinal axis, a distal end, and a proximal
end having a cylindrical neck portion, a circumferential wall extending
from an interior end of the cylindrical neck portion to an outer
surface of the proximal end of syringe casing; a plunger having
a weak portion, a distal portion, and a coupling portion comprising
a plurality of hooks, wherein the plunger is channeled in the syringe
casing and is moveable from an extended position to a compressed
position; a stopper having a membrane, wherein the stopper is affixed
to the coupling portion of the plunger, and wherein the membrane
is between the proximal end of the syringe casing and the plunger;
a needle holder housed in the cylindrical neck portion of the syringe
casing; a distally facing arrowhead attached to a distal end of
the needle holder; a proximally facing needle attached to a proximal
end of the needle holder and having a needle axis and a needle tip,
the method comprising the steps of: moving the plunger from the
extended position to the compressed position; puncturing the membrane
with the arrowhead when the plunger is in the compressed position;
coupling the arrowhead to each of the hooks of the coupling portion;
returning the plunger to the extended position and thereby drawing
the needle holder and the needle into an interior of the syringe
casing; and preventing needle reuse by performing a step selected
from the group consisting of: altering the orientation of the needle
axis with respect to the syringe casing axis from an orientation
in which the axes are substantially parallel to an orientation in
which the needle tip will encounter the circumferential wall if
the plunger is moved back toward the compressed position; and disengaging
the distal portion of the plunger from the weak part.
18. The method according to claim 17 further comprising the step
of: bending the needle when the needle tip encounters the circumferential
wall and when the plunger is moved toward the compressed position
after the step of altering the orientation of the needle axis with
respect to the syringe casing axis.
19. The method according to claim 17 wherein the weak part of
the plunger includes a plurality of tines, and wherein the step
of disengaging the distal portion of the plunger from the weak part
comprises breaking the tines.
Safety syringe description
BACKGROUND OF THE INVENTION
This application claims priority to, and incorporates by reference,
Chinese Patent Application No. 00205827.8 filed on Feb. 24 2000.
1. Field of the Invention
The present invention relates to a syringe, particularly, to a
safety syringe, belonging to the medical device technical field.
Safety syringes are designed for one-time use and are, therefore,
not re-useable.
2. Background of the Art
In the medical field, there is a great need to avoid cross-contamination
or infection which may be caused when a syringe is used more than
once. Single use syringes have long been thought as being one way
to avoid these potential problems. However, current single use syringes
present a variety of problems. Some syringes which claim to be "single
use" in actuality can be reused with user intervention. Some
syringes are designated as "single use" solely because
they are to be discarded after use pursuant to a regulation; nothing
prevents their reuse. Some syringe designs expose the drug or bodily
fluid contained therein to reactive components of the syringe (e.g.
a spring used to retract the plunger). In addition, some syringes,
although not capable of being reused, present health risks to the
medical personnel handling them. Accordingly, there is a need for
a single use syringe which is: (a) easy to use; (b) incapable of
being reused; (c) presents little or no danger to medical personnel
after use; (d) designed in such a way as to prevent contact between
reactive syringe components and the fluid contained within the syringe;
and (e) capable of being manufactured at low cost.
Currently, there are mainly two classes of safety syringes. One
class of syringes, which employs a spring to retract a needle into
the syringe, is represented in U.S. Pat. Nos. 5769822 5980494
and 6039713. Although these syringes are effective and easy to
use, the also have inherent disadvantages. First, the spring-loaded
structure is complicated because of the number of parts involved
creates difficulties in constructing the syringe. Second, due to
the complicated structure, the costs of manufacturing are high making
marketing difficult. Third, due to the location of the spring at
the needle end of the syringe, it is difficult to position the fluid
close to the inlet to the needle; this increases fluid residue and
makes removal of air bubbles more difficult.
The second class of syringes employs a locking mechanism on the
plunger which engages a corresponding structure at the base of the
needle when the plunger is completely compressed. A subsequent withdrawal
of the plunger pulls the needle into the syringe barrel. The structure
of these syringes is simpler and the cost of production lower in
comparison to the former class. However, this class of syringes
also has disadvantages. For example, in Chinese Patent CN2270509Y,
the corresponding parts of the locking mechanism between the needle
and the plunger are exposed to fluid contained within the syringe.
Accordingly, any burrs on the parts which result from manufacturing
may fall into the fluid and be thereafter accidentally transmitted
to the patient giving rise to a potentially dangerous situation.
In addition, in many of these syringes, the locking mechanism can
be disengaged and the syringe reused.
U.S. Pat. No. 5601534 discloses a one-time-use safety syringe
comprising a simple structure which reliably releases gases and
retains a very small amount of residual fluid. However, it also
presents disadvantages. The structure employs an inward facing needle
extension which is bent by an arrowhead attached to the plunger.
The extension is bent into a cavity in the plunger such that when
the plunger is pulled away from the needle, the needle is pulled
into the syringe barrel.
A first disadvantage is that the size of the extension must correspond
to the size of the needle; a large needle requires a large extension
which is not as easily bent thereby degrading the integrity of the
engagement with the plunger.
A second disadvantage is that the rubber stopper, which houses
the cavity, is solid. Due to the solid nature of the stopper, the
extension must completely pierce the stopper to create a strong
engagement with the cavity. To create this strong engagement requires
a strong compression of the plunger at the completion of the injection;
this can be difficult when the needle and needle extension are large.
A third disadvantage results with large needles. A large compressive
force needs to be applied to the plunger to complete an injection
with a large needle. This force counteracts the force necessary
for the needle extension to puncture the plunger. To address this
problem, the needle's engagement with the barrel head needs to enhanced.
However, by enhancing the needle's engagement with the barrel head,
it becomes more difficult to withdraw the needle into the syringe
barrel after the injection is complete.
Fourth, the engagement of the needle extension and the plunger
is such that upon withdrawal of the needle into the syringe barrel,
residual fluid in the barrel can leak out of the syringe.
Fifth, the size of the plunger cavity corresponds to the size of
the needle. Accordingly, one plunger can not be used with a variety
of needle sizes. Therefore, medical personnel must maintain an inventory
of various sizes of plungers which is costly and which occupies
precious storage space.
SUMMARY
A solution to the aforementioned deficiencies in the art are resolved
by the safety syringe herein described. Specifically, the presently
described syringe has the following advantages over the prior art:
(a) the hooks within the stopper which engage the arrowhead are
not in contact with the fluid contained in the syringe thereby reducing
the potential for manufacturing burrs to fall into the fluid and
thereby be injected into the patient. The structure is possible
because the engagement of the needle holder and the plunger occurs
when the arrowhead pierces the stopper membrane. After the completion
of the injection thereby establishing this engagement, the syringe
can not be reused. Moreover, the puncturing of the membrane requires
a force which is much smaller than the force necessary to compromise
the o-ring seal in the plunger neck; accordingly the counteractive
force problems in the prior art are eliminated; (b) the o-ring positioned
in the syringe neck prevents fluid from escaping when the needle
is initially pulled toward the syringe barrel; (c) the syringe has
a simple structure which is both easy to use and manufacture; (d)
the cavity in the stopper and the arrowhead can be used with any
size needle (i.e. the size of the cavity and the arrowhead is not
dependent on the size of the needle); and (e) the size of the needle
does not compromise the integrity of the locking between the plunger
and the needle holder.
These and other advantages are made possible by a safety syringe
comprising a syringe casing having a distal end and a proximal end.
A plunger is channeled in the syringe casing and is capable of moving
from an extended position to a compressed position. The plunger
has a weak portion, a distal portion, and a coupling portion. A
stopper, having a membrane, is affixed to the coupling portion of
the plunger; the membrane is between the proximal end of the syringe
casing and the plunger. A needle holder, initially coupled to the
proximal end of the syringe casing, has a distally facing arrowhead
and a proximally facing needle. When the plunger is moved from the
extended position to the compressed position, the arrowhead punctures
the membrane and lockingly engages the coupling portion of the plunger.
Subsequently, when the plunger is returned to the extended position,
the needle holder and needle are drawn into an interior of the syringe
casing.
In the safety syringe above-described, the weak part of the plunger
may include a plurality of tines. In this situation, when the plunger
is returned to the extended position from the compressed position,
the distal portion of the plunger may be disengaged from the weak
portion by breaking the tines.
In a preferred embodiment, the safety syringe includes a plurality
of o-rings formed on an outer surface of the stopper. The plurality
of o-rings frictionally engage an inner surface of the syringe casing
when the plunger is moved between the extended position and the
compressed position.
In the safety-syringe above-described, the proximal end of the
syringe casing comprises a cylindrical neck portion which houses
the needle holder. The cylindrical neck portion comprises a circumferential
channel formed on an inner surface thereof. The needle holder comprises
a circumferential o-ring on an outer surface thereof which is sized
to substantially fill the channel.
The safety-syringe may also include a safety mechanism. The safety
mechanism comprises a check plate which is affixed to an outer surface
of the syringe casing and which is adapted to move from an unlocked
position to a locked position. The check plate is designed to engage
a notch in a side of the distal portion of the plunger. When the
check plate is in the locked position, it engages the notch thereby
preventing the plunger from moving from the extended position to
the compressed position.
In the presently described safety syringe, the needle and the syringe
casing have longitudinal axes. Before engagement of the arrowhead
and the coupling portion, the needle axis and the syringe casing
axis are substantially parallel. By way of contrast, after the needle
holder and the needle are drawn into the interior of the syringe
casing, a mechanism alters the orientation of the needle axis with
respect to the syringe axis so that they are not substantially parallel.
Additionally, the proximal end of the syringe casing comprises a
cylindrical neck portion which houses the needle holder; a circumferential
wall extends from an interior end of the cylindrical neck portion
to an outer surface of the proximal end of syringe casing. Due to
the misalignment of the needle axis and the syringe casing axis,
the needle will contact the wall if the plunger is moved toward
the compressed position.
Ideally, the stopper substantially covers the coupling portion
of the plunger when the plunger is in the extended position. Moreover,
when the plunger is in the compressed position (i.e., after engagement
of the arrowhead and the coupling portion housed within the stopper),
the stopper substantially covers the arrowhead and the coupling
portion.
A second embodiment of a safety syringe includes a syringe barrel
and a needle holder, having an arrowhead at a rear portion thereof,
sealingly installed onto a front end of the syringe barrel. The
arrowhead has a circumferential groove disposed at its base. A needle
is sleeved onto the needle holder. A cylindrical rubber stopper,
coupled to a plunger, has a membrane at on one end and a bore at
the other end. The plunger has an coupling portion dimensioned to
engage the arrowhead. The rubber stopper is hollow and is sleeved
over the plunger coupling portion. Moreover, the plunger is moveable
between an extended position and an compressed position at which
an injection is completed. The rubber stopper and the plunger are
sequentially installed into the syringe barrel.
In the syringe of this type, the membrane end of the rubber stopper
faces the arrowhead; at the completion of the injection, the arrowhead
pierces the membrane and engages the coupling portion. After this
engagement, when the plunger is drawn backwards towards the extended
position, the needle holder and the needle are drawn into the syringe
barrel.
Preferably, the syringe also includes an inner sealing channel
on an internal side of the front end of the syringe barrel. Correspondingly,
a sealing ring sleeved onto the needle holder is preferably dimensioned
to match the inner sealing channel. A rear portion of the inner
sealing channel should have a smaller arc than an arc of the sealing
ring. Moreover, a frontal portion of the inner sealing channel should
have an inclined face having an arc larger than the arc of the rear
portion. In a syringe having these channel characteristics, the
needle holder can be slideably engaged in the front end of the syringe
barrel by means of the sealing ring and can be moved in the direction
of the syringe barrel when the plunger is withdrawn are engagement
of the arrowhead and coupling portion.
The plunger in a safety syringe of this nature preferably comprises
a weak portion and a resistance plate fixedly connected to the coupling
portion. Moreover, the plunger preferably has a "+" shaped
formed by a vertical rib plate and a horizontal cross rib plate.
The vertical rib plate is weakly connected to the resistance plate
by means of a plurality of tines. After completion of the injection
and after the needle holder and needle are drawn into the syringe
barrel, the tines of the weak portion can be broken upon application
of a bending moment.
Similar to the first embodiment, the safety syringe may also include
a mechanism by which premature use of the syringe is prevented.
Specifically, the syringe may include a safety mechanism having
a wing plate, a check plate, and a flexible film connecting the
wing plate and the check plate. The safety mechanism is positioned
on an exterior surface of the syringe barrel at a position proximate
to an insertion bore into which the plunger is inserted. The check
plate and one rib of the vertical rib plate have corresponding grooves
which may be engaged if the check plate is rotated toward the vertical
rib plate by means of the flexible film. If the grooves of the check
plate and the vertical rib plate are engaged, premature completion
of the injection is prevented.
Ideally, a plane forming the base of the arrowhead is not perpendicular
to a central axis of the syringe barrel. In this fashion, after
the needle is drawn into the syringe barrel, the axis of the needle
will be directed toward an inner wall of the syringe barrel; a subsequent
re-compression of the plunger toward the compressed position will
cause the needle to abut the inner wall of the syringe barrel.
The present invention also contemplates a method for preventing
reuse of a syringe. The method uses a syringe having a syringe casing
which, in turn, has a longitudinal axis, a distal end, and a proximal
end having a cylindrical neck portion. In the syringe used by the
method, a circumferential wall extends from an interior end of the
cylindrical neck portion to an outer surface of the proximal end
of syringe casing. A plunger having a weak portion, a distal portion,
and a coupling portion, is channeled in the syringe casing and is
moveable from an extended position to a compressed position. A stopper
having a membrane is affixed to the coupling portion of the plunger;
the membrane is between the proximal end of the syringe casing and
the plunger. A needle holder, housed in the cylindrical neck portion
of the syringe casing, has a distally facing arrowhead and a proximally
facing needle having an axis and a needle tip.
The method includes: (I) moving the plunger from the extended position
to the compressed position; (II) puncturing the membrane with the
arrowhead when the plunger is in the compressed position; (III)
coupling the arrowhead to the coupling portion; (IV) returning the
plunger to the extended position and thereby drawing the needle
holder and the needle into an interior of the syringe casing; and
(V) preventing reuse of the needle by either (a) altering the orientation
of the needle axis with respect to the syringe casing axis from
an orientation in which the axes were substantially parallel to
an orientation in which the needle tip will encounter the circumferential
wall if the plunger is moved back toward the compressed position
or (b) disengaging the distal portion of the plunger by breaking
the weak part.
In the method in which the preventing reuse of the needle is preformed
by altering the orientation of the needle axis with respect to the
syringe casing, a further step is possible. This method may also
include bending the needle when the needle tip encounters the circumferential
wall when the plunger is subsequently moved toward the compressed
position.
In addition, in the method in which the preventing reuse of the
needle is performed by disengaging the distal portion of the plunger
from the weak part, the disengagement may occur if the weak part
of the plunger is comprised of a plurality of tines which are easily
broken upon application of a bending moment applied to the plunger
when the plunger is in the extended position.
BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying figures, which are incorporated in and constitute
a part of the specification, illustrate presently preferred embodiments
of the invention. Together with the above general description and
the following detailed description, the figures serve to explain
the principles of the invention.
FIG. 1 is a cross sectional side view of a syringe showing the
syringe prior to complete compression of the plunger and where a
locking mechanism, in a locked position, prevents such compression;
FIG. 2 is a cross sectional side view of a syringe showing the
needle drawn into the chamber after the syringe's one-time use;
FIG. 3 is a cross sectional side view of a syringe showing the
needle destroyed where a user tried to reuse the syringe;
FIG. 4 is a cross sectional side view of a syringe showing how
the plunger can be broken, after use, to prevent reuse of the syringe;
FIG. 5 is a perspective view of the needle holder;
FIG. 6 is a cross sectional side view of a syringe casing;
FIG. 7 is a side view of a plunger.
FIG. 8 is a side view of a weak part of a plunger at which the
plunger may be broken after the syringe is used showing the needle
end and the pushing end portions of the plunger attached at the
weak part;
FIG. 9 is a side view of the weak part of the plunger of FIG. 8
showing only the needle end portion attached to the weak part;
FIG. 10 is a cross-sectional view of a stopper into which the needle
portion of the stopper is inserted;
FIG. 11 is a cross sectional side view showing the engagement of
the plunger and the needle holder; and
FIG. 12 is a top end view of the syringe casing showing the locking
mechanism and finger supports.
DETAILED DESCRIPTION
A preferred embodiment of a safety syringe 1 will be hereafter
described with reference to the figures. FIG. 1 shows a non-activated
safety syringe 1 comprising a plunger 2 having a weak part 3 a
coupling portion 4 and a distal portion 5. The plunger sits within
a syringe casing 24. Attached to the coupling portion 4 of the plunger
2 is a stopper 11. The area within the casing 24 between a needle
holder 16 and the stopper 11 defines a fluid chamber 14 which contains
a fluid to be administered to a patient.
FIG. 7 shows a side view of the plunger 2 whereas FIG. 8 focuses
on the weak part 3 of the plunger 2. On either side of the weak
part 3 are the coupling portion 4 and the distal portion 5. The
coupling portion 4 has a front resistance plate 42. The resistance
plate 42 has a transitional arc brim on its front face whereas its
rear face is substantially flat. The outer diameter of the resistance
plate 42 is equal to or slightly smaller than the inner diameter
of the syringe casing 24. Although the diameter of the resistance
plate 42 can be 0.1 mm smaller than the inner diameter of the syringe
casing 24 it should be larger than the inner diameter of a resistance
ring 37 (hereafter described) circumferentially formed on the inner
surface of the syringe casing 24 (as shown in FIG. 6). Preferably,
the weak part 3 is comprised of a small number of tines 8 which
are attached to and positioned between the front resistance plate
42 and the distal portion 5. The tines 8 are designed to break easily
when a bending moment is applied to the distal portion 5 when the
plunger 2 is in a fully extended position. However, numerous other
embodiments can be employed to create a breakable weak part 3.
The coupling portion 4 contains a plurality of hooks 6 which are
designed to engage an arrowhead 7 as described below. The distal
portion 5 on the other hand, can have a variety of cross sections.
To balance cost and effectiveness, a "+" shape is preferable
for the distal portion 5; if this configuration is used, it is preferable
to have a flat plate 32 affixed to the end of the plunger 2 so that
a user will have a broad flat surface on which to place a thumb
when compressing the plunger 2 into the syringe casing 24. If the
"+" shape is employed to form the distal portion 5 one
plane of the distal portion 5 (i.e. a vertical rib plate 43) may
have tines 8 extend therefrom (and attach to the front resistance
plate 43) whereas the other plane of the "+" shaped distal
portion 5 (i.e. a horizontal rib plate 44) may have no such tines
8. Moreover, if the "+" shape is employed, in one of the
sides of the cross section, a notch 9 may be positioned. The notch
9 is designed to engage a safety mechanism 10 which is preferably
attached to the syringe casing 24 as described below.
As can be seen in FIG. 10 centrally positioned in one end of a
stopper 11 is a bore 12 which leads to a cavity 45. The bore 12
does not completely penetrate the stopper 11. Rather, the other
end of the stopper 11 comprises a membrane 13 the function of which
is hereafter described. However, the bore 12 is extended by a smaller
diameter bore 41 which extends to an inner side of the membrane
13. In construction, the coupling portion 4 of the plunger 2 is
completely inserted into the bore 12 of the stopper 11 until it
rests in the cavity 45. Preferably, the stopper 11 is made of rubber
or a rubber-like material which allows the stopper to prevent the
fluid (to be administered to a patient) from escaping a fluid chamber
14 in the syringe 1. In preventing the passage of such fluids, the
stopper 11 has a plurality of o-rings 15 formed along its outer
circumference which frictionally engage the inner surface of the
fluid chamber 14. The stopper 11 substantially covers the hooks
6 of the coupling portion 4 of the plunger 2; the hooks 6 are positioned
in the cavity 45 and are covered by the membrane 13 prior to an
activation of the syringe described below.
FIG. 5 which shows a perspective view of a needle holder 16 depicts
another o-ring 17 in a central portion of the needle holder 16.
The o-ring 17 of the needle holder 16 sits within a circumferential
channel and prevents the fluid (to be administered to a patient)
from escaping the syringe 1 through a bore 18 described below,
and also prevents accidental needle ejection when large compressive
loads are applied to the plunger 2. The o-ring 17 is designed to
engage a circumferential channel 26 in the cylindrical neck portion
25 of the syringe casing 24 (as shown in FIG. 2) as hereafter described.
On one side of the o-ring 17 is a needle adapter 19 onto which
a needle 20 is fixed. The needle adapter 19 is conical in shape
which allows needles of various sizes to be fixed on the needle
holder 16. On the other side of the o-ring 17 is an arrowhead 7.
On one end of the arrowhead is a point 29. At the base of the arrowhead
7 is a circumferential groove 28 designed to engage the hooks 6
of the plunger 2 as described below. The base of the arrowhead
7 is made to be inclined, i.e. the angle of the base is at an angle
a with respect to a coplanar line which is perpendicular to the
axis of the syringe casing 24; the angle is preferably approximately
5 degrees. This angular orientation allows the needle holder 16
to be oriented at an angle when it is withdrawn into the syringe
casing 24 as described below.
At the base of the groove 28 there are two flaps 40 which are designed
to engage the wall 31 (as shown in FIG. 2) in the cylindrical neck
25 when the needle holder 16 is positioned in the cylindrical neck
25. By engaging the wall 31 the flaps 40 prevent the needle holder
16 from being ejected when the plunger 2 is compressed. Moreover,
the engagement of the flaps 40 and the wall 31 reduces injection
residue.
A needle holder axis 23 is defined by a line passing through the
arrowhead 7 in the direction of the needle adapter 19. Positioned
in the needle adapter 19 of the needle holder 16 is a bore 22 which
travels from the needle adapter end of the needle holder 16 along
the axis 23 to a position on needle holder 16 which is on the arrowhead
7 side of the o-ring 17; the bore 22 does not extend into the arrowhead
7. A trans-bore 21 is perpendicularly drilled through the needle
holder 16 at the end of the bore 22 i.e. perpendicular to the axis
23 of the needle holder 16. The two bores 21 and 22 thereby form
a "T" shaped channel in the needle holder 16. When a needle
20 is attached to the needle adapter 19 the "T" shaped
channel extends into the needle. This construction allows a fluid,
housed within the fluid chamber 14 to pass through the "T"
shaped channel (when the plunger 2 is depressed), through the needle
20 and into a patient.
FIG. 6 shows a cross sectional side view of the syringe casing
24. The casing 24 is substantially cylindrical and hollow. On one
end of the casing 24 there is a narrower cylinder 25 which extends
from the casing 24. Prior to use, the cylinder 25 (which comprises
bore 18) holds the needle holder 16 with the arrowhead 7 distally
extending into the fluid chamber 14. In the cylinder 25 there is
a circumferential channel 26 on the inner surface of the cylinder
25. O-ring 17 of the needle holder 16 initially rests within channel
26 and thereby prevents drugs, stored in the fluid chamber 14 from
being able to leak out of the syringe 1. The circumferential channel
26 has an asymmetric cross-section; the rear portion 38 has the
same arc as the o-ring 17 whereas the frontal portion 39 (i.e. the
portion closest to the needle end of the syringe 1) has a larger
arc.
Attached to the other end of the casing 24 are two finger supports
33 (as shown in FIG. 12) and the safety mechanism 10. Safety mechanism
10 is formed onto the casing in such a way as to allow it to swing
toward and away from the plunger 2 when the plunger 2 is positioned
within the casing 24. To allow the safety mechanism 10 to swing,
the safety mechanism is comprised of a wing plate 34 (which is a
part of the finger support 33) which is connected to a check plate
35 by means of a thin plastic film 36. Preferably, the check plate
35 has a notch 27 (as shown in FIG. 12) which is sized to correspond
to the thickness of one of the sides of the "+" shaped
plunger. When the check plate 35 is rotated from an unlocked position
and toward the plunger 2 and thereby into a locked position, the
notch 27 of the check plate 35 may engage the notch 9 in one of
the sides of the "+" shaped plunger 2. A user will be
unable to activate (as described below) the syringe 1 by depressing
the plunger 2 while the notch 27 is engaged with notch 9 as this
engagement prevents further compression of the plunger 2; accordingly,
completely activation of the syringe 1 is avoided.
In addition, the rear end of the syringe casing 24 also comprises
a resistance ring 37 formed on the interior of the casing 24 near
the end of the casing 24 in which the plunger is inserted. The resistance
ring 37 has a cross-section substantially triangular in shape. The
cross-section of the ring 37 is such that the portion 47 of the
cross-section facing the needle end of the syringe 1 is steeper
than the portion 48 facing the plunger 2 end of the syringe 1. In
this fashion, the portion 47 of the ring 37 facing the needle 20
end of the syringe 1 has a larger axial angle with respect to the
axis of the syringe casing 24; the angle is preferably about 60
degrees. The side of the ring 37 facing the plunger 2 end of the
syringe 1 has a smaller axial angle with respect to the axis of
the syringe casing 24; the angle is preferably about 10 degrees.
During assembly, the needle holder 16 is channeled into the syringe
casing 24 through the plunger 2 end of the casing 24. The needle
holder 16 is then pushed forward until the o-ring 17 snaps into
the circumferential channel 26 and the flaps 40 hit a circumferential
rim 46 located in the cylindrical neck portion 25 adjacent the circumferential
wall 31. The hooks 6 of the plunger 2 are inserted into the bore
12 in the stopper 11 until the are housed in the cavity 45; the
combination of the plunger 2 and the stopper 11 is then inserted
into the syringe casing 24. In so doing, the front resistance plate
42 of the plunger 2 rides over the resistance ring 37 to become
permanently housed with the syringe casing 24. The check plate 35
of the safety mechanism 10 should be turned down toward the plunger
2 (i.e. into the locked position) by means of the bendable film
plastic film 36 and its notch 27 should be aligned with the side
of the "+" shaped plunger containing the corresponding
notch 9 so that an engagement of the notches 9 27 can occur thereby
preventing complete compression of the plunger 2 in the syringe
casing 24.
Activation of the syringe 1 occurs as follows. When the safety
mechanism 10 is not engaged with one of the sides of the plunger
2 and a user depresses the plunger 2 to compress the fluid chamber
14 drugs in the fluid chamber are forced into the "T"
shaped channel of the needle holder 16 and into (and out of) the
needle 20. As the plunger is compressed, the membrane 13 of the
stopper 11 approaches the arrowhead 7. With continued compression,
the point 29 of the arrowhead 7 pierces the membrane 13 causing
the arrowhead 7 to pass through bore 41 and into cavity 45 in which
the arrowhead 7 engages the hooks 6. Again, with continued compression,
the arrowhead 7 radially separates the hooks 6 to a point at which
the hooks 6 snap into the circumferential groove 28 around the base
of the arrowhead 7 as shown in FIG. 11. In this fashion the arrowhead
7 and the plunger 2 become permanently engaged within the stopper
11. Due to the engagement of the hooks 6 with the circumferential
groove 28 when a user pulls on the plunger 2 the needle holder
16 (to which the arrowhead 7 is attached) and the needle 20 are
pulled into the syringe casing 24. The user is unable to pull the
plunger (with needle attached) out of the syringe casing 24 because
front resistance plate 42 of the plunger 2 engages the frontal portion
47 of the resistance ring 37.
As shown in FIG. 4 when the needle 20 is completely pulled into
the syringe casing 24 the distal portion 5 of the plunger 2 extends
well out of the casing 24. With a small bending moment applied to
a side of the distal portion 5 the tines 8 of the weak point 3
break. As shown in FIGS. 4 and 9 when the tines 8 break, the distal
portion 5 of the plunger 2 becomes disengaged from the coupling
portion 4 of the plunger 2. Without the distal portion 5 attached
to the coupling portion 4 of the plunger 2 a user is unable to
push the needle 20 back out of the casing 24. If, on the other hand,
the user does not break the distal portion 5 and instead tries to
push the needle 20 out of the casing 24 the user will be unable
to push the needle 20 out of the casing 24 for the reason discussed
below.
As shown in FIG. 2 when the needle holder 16 is drawn into the
casing 24 (after complete activation) and the skin contact end 30
of the needle 20 clears the bore 18 of the cylinder 25 the skin
contact end 30 of the needle 20 is forced toward the inner surface
of the casing 24. The needle 20 is tipped toward the inner surface
of the casing 24 because the arrowhead 7 and hooks 6 are engaged
at an angle of approximately 5 degrees; the angular orientation
is caused by the inclined base of the arrowhead 7 as previously
described. In this fashion, the axis defined by the needle 20 (when
completely within the casing 24) is not parallel to the axis upon
which the plunger 2 is pulled by the user. As shown in FIG. 3 if
a user tries to push the needle 20 back out of the casing 24 the
skin contact end 30 of the needle 20 does not pass through bore
18 but rather contacts a wall 31 of the casing which extends circumferentially
from the outer surface of the casing 24 toward the cylinder 25.
Due to the contact between the skin contact end 30 of the needle
20 and the wall 31 the needle is unable to exit the casing 24.
Moreover, if the user continuously increases the force applied to
the plunger 2 the needle will collapse.
Although the aforementioned described a preferred embodiment of
the invention, the invention is not so restricted. The foregoing
description is for exemplary purposes only and is not intended to
be limiting. Accordingly, alternatives which would be obvious to
one of ordinary skill in the art upon reading the teachings herein
disclosed, are hereby within the scope of this invention. The invention
is limited only as defined in the following claims and equivalents
thereof. |