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 recompressed, 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 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, 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, 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.
2. The syringe according to claim 1 wherein the weak part of the
plunger includes a plurality of tines.
3. The syringe according to claim 2 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.
4. The syringe according to claim 1 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.
5. The syringe according to claim 1 wherein the proximal end of
the syringe casing comprises a cylindrical neck portion which houses
the needle holder.
6. The syringe according to claim 5 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.
7. The syringe according to claim 1 further comprising: 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 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.
8. 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 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.
9. The syringe according to claim 1 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.
10. The syringe according to claim 9 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.
11. The syringe according to claim 1 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.
12. 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
channel 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.
13. The syringe according to claim 12 further comprising: an inner
sealing groove 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 groove, wherein a rear portion of the
inner sealing groove has a smaller arc than an arc of the sealing
ring, wherein a frontal portion of the inner sealing groove 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.
14. The syringe according to claim 12 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.
15. The syringe according to claim 14 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.
16. The syringe according to claim 12 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 recompression
of the plunger toward the compressed position causes the needle
to abut the inner wall of the syringe barrel.
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, 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 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
[0001] This application claims priority to, and incorporates by
reference, Chinese Patent Application No. 00205827.8 filed on Feb.
24 2000.
[0002] 1. Field of the Invention
[0003] 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.
[0004] 2. Background of the Art
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] 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.
[0011] 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.
[0012] 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
[0013] 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.
[0014] 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.
[0015] 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.
[0016] 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.
[0017] 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.
[0018] 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.
[0019] 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.
[0020] 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.
[0021] 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 channel 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.
[0022] 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.
[0023] Preferably, the syringe also includes an inner sealing groove
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 groove. A rear portion of the inner sealing
groove should have a smaller arc than an arc of the sealing ring.
Moreover, a frontal portion of the inner sealing groove should have
an inclined face having an arc larger than the arc of the rear portion.
In a syringe having these groove 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.
[0024] 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.
[0025] 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.
[0026] 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 recompression of the plunger toward the compressed
position will cause the needle to abut the inner wall of the syringe
barrel.
[0027] 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.
[0028] 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.
[0029] 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.
[0030] 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
[0031] 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.
[0032] 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;
[0033] 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;
[0034] FIG. 3 is a cross sectional side view of a syringe showing
the needle destroyed where a user tried to reuse the syringe;
[0035] 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;
[0036] FIG. 5 is a perspective view of the needle holder;
[0037] FIG. 6 is a cross sectional side view of a syringe casing;
[0038] FIG. 7 is a side view of a plunger.
[0039] 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;
[0040] 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;
[0041] FIG. 10 is a cross-sectional view of a stopper into which
the needle portion of the stopper is inserted;
[0042] FIG. 11 is a cross sectional side view showing the engagement
of the plunger and the needle holder; and
[0043] FIG. 12 is a top end view of the syringe casing showing
the locking mechanism and finger supports.
DETAILED DESCRIPTION
[0044] 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.
[0045] 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.
[0046] 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.
[0047] 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.
[0048] 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.
[0049] 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
.alpha. 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.
[0050] 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.
[0051] 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.
[0052] 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 crosssection; 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.
[0053] 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.
[0054] 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.
[0055] 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.
[0056] 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.
[0057] 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 FIG. 9 when the tines 8 break, the distal
portion 5 of the plunger 2 becomes disengaged from the plunger 2.
Without the distal portion 5 attached to 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.
[0058] 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.
[0059] 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. |