Safety syringe abstract
A safety syringe includes a barrel, a needle-carrier and a plunger.
The plunger and the needle-carrier each have a coupling system which
connects them by a simple axial push of the plunger. The distal
part of the barrel has an internal annular stop. The central part
of the needle-carrier has an external diameter corresponding to
the internal diameter of the annular stop while the proximal extremity
of this part of the needle-carrier has a diameter corresponding
to the internal diameter of the distal part of the barrel. Elements
are provided to prevent temporarily the needle-carrier from being
pushed inside the barrel through axial pressure against the distal
tip of the needle-carrier.
Safety syringe claims
What is claimed is:
1. A safety syringe for medical use comprising:
a barrel having a distal part and a proximal part;
a needle-carrier sliding in a watertight fashion in the distal
part of the barrel;
a plunger having a shaft and sliding in a watertight fashion in
the proximal part of the barrel;
the plunger and the needle-carrier each comprising a coupling organ
interconnecting by a simple axial push on the plunger to enable
the needle-carrier with its needle to be withdrawn inside the barrel
after injection;
the distal part of the barrel having an internal annular stop which
prevents the needle-carrier from being pulled or pushed out of the
barrel through its distal opening;
a central part of the needle-carrier having an external diameter
greater than the internal diameter of the annular stop;
a proximal part of the needle-carrier having a diameter corresponding
to the internal diameter of the distal part of the barrel;
manually operated control means slidably mounted on the barrel
and comprising locking members, displaceable from a forward locking
position where said members positively lock the needle-carrier in
its forward-most distal position in the barrel and prevents said
needle-carrier from being pushed inside the barrel due to an axial
pressure applied to a distal end of the needle-carrier, or from
being withdrawn inside the barrel by the plunger to a retracted
unlocked position after the locking members are disengaged from
the needle-carrier, which is then free to be pulled or withdrawn
inside the barrel.
2. The syringe according to claim 1 wherein the manually operable
control means comprise a cursor formed by a ring sliding freely
around the barrel and including at least one flexible locking finger
having a tip which lodges, when in its forward locking position,
in a groove of the needle-carrier.
3. The syringe according to claim 2 wherein the barrel has an
annular groove around its distal part for parking the fingers of
the cursor when in a slid-back position to free the needle-carrier.
4. The syringe according to claim 1 wherein the coupling organ
comprises a catch covering only one part only of a tronconical internal
surface of the proximal part of the needle-carrier, while a member
of the plunger which couples the plunger to the needle-carrier comprises
at least three fingers fixed to the shaft of the plunger advancing
axially in the direction of the distal extremity of the barrel;
said fingers comprising ends having an external conical surface
and a hooking ridge designed to cooperate with a conical wall of
the needle-carrier and the catch by elastic deformation of said
fingers upon pushing the plunger against the needle-carrier.
5. The syringe according to claim 4 wherein the catch and the
needle-carrier do not occupy the entire periphery of the internal
conical surface of the proximal part of the needle-carrier so that
due to the elasticity of the fingers of the plunger, the needle-carrier
takes up an oblique position, inclined in relation to the axis of
the syringe when said needle-carrier is withdrawn inside the barrel.
6. The syringe according to claim 5 wherein the internal annular
stop is formed by a rim facing in the direction of the axis of the
syringe which reduces the diameter of the distal opening of the
barrel.
7. The syringe according to claim 1 wherein the plunger comprises
a head provided with a groove in which a seal is positioned sliding
in a watertight fashion against the inner wall of the barrel.
8. The syringe according to claim 1 wherein the proximal extremity
of the barrel comprises a stop ring formed by an internal annular
projection of the barrel wall; said projection presenting a conical
part decreasing in the direction of the proximal end of the barrel
and an annular face in the direction of the distal part of the barrel;
said stop ring preventing the plunger from being withdrawn from
the barrel through its proximal opening.
9. The syringe according to claim 1 wherein the central part of
the needle-carrier comprises an annular groove.
10. The syringe according to claim 1 wherein the external surface
of the proximal part of the needle-carrier has a groove in which
is housed a circular seal.
11. The syringe according to claim 1 wherein the shaft of the
plunger has a general shape of a Y.
12. The syringe according to claim 1 wherein the distal tip of
the plunger has a passage connecting distal and proximal chambers
of the barrel separated by said plunger; an element of variable
resistance held between the fingers for holding means of blocking
said passage; said element having a mechanical resistance which
is lower when wet than when dry.
13. The syringe according to claim 1 wherein the barrel comprises
a finger-grip collar positioned at a distance of between 1 to 2
cm from the proximal extremity of the barrel.
14. The syringe according to claim 1 wherein the coupling of the
plunger into the needle-carrier is unlockable by a simple axial
pulling.
Safety syringe description
FIELD OF THE INVENTION
The present invention concerns safety syringes for medical uses
which permit the limitation and if possible the avoidance of injury
to healthcare workers. The aim of these safety syringes is evidently
to avoid risk of contamination during handling of the syringe and
to prevent the needle, after administering an injection into a patient
suffering from an illness such as viral hepatatis or AIDS, from
injuring the nurse before the needle has been safely protected
BACKGROUND OF THE INVENTION
Such safety syringes are known in documents WO 90/06148 EP 0.326.983
EP 0.347.742 U.S. Pat. No. 4507177 or U.S. Pat. No. 4675005.
All of the syringes described in these documents necessitate the
retracting of the needle into the syringe barrel after use, but
by complicated manipulations involving rotary movements, coupling
by bayonet etc. which are impractical movements which hospital personnel
are not used to carrying out and which require the use of two hands,
one of which can approach the sharp tip of an infected needle.
SUMMARY OF THE INVENTION
The aim of the present invention is to create a safety syringe
for medical use permitting the needle to be retracted inside the
cylinder after use but which can be utilized in the same way as
all standard syringes for its preparation and use, that is to say
fixing the required needle, filling, changing needle if necessary,
coupling onto an air filter if necessary, evacuation of air-bubbles
and injection. Nevertheless, the difference and the advantage compared
to standard syringes is that the operator's hands cannot approach
the dangerous distal zone of the syringe which is a source of injury
because it is obligatory that the active hand which pulls the piston
is occupied at the proximal extremity of the syringe.
Another aim of the invention is to prevent the user to try to re-cap
the infected needle or to have to dispose of this needle in a specialized
disposal box which is not always handy. Yet another aim is to facilitate
the reading of the volume of liquid introduced through the needle.
Another aim of the present invention is the creation of a purely
mechanical syringe having a small number of parts, easy to manufacture
and at low cost compared to other known safety syringes, and with
a cost comparable to existing low-cost standard single-use syringes.
Another aim of the present invention is the creation of a safety
syringe which allows the user, before employing the syringe, to
choose the appropriate standard needle and to fix it onto the syringe
the same as with low-cost conventional single use syringes, which
is often not possible with safety syringes.
The objective of the present invention is a safety syringe which
avoids the disadvantages of existing syringes permitting the above
mentioned aims to be reached, comprising a barrel, a plunger which
can be moved linearly and remain watertight and a needle carrier
similarly movable linearly inside the barrel and which distinguishes
itself by the characteristics listed in claim 1.
BRIEF DESCRIPTION OF THE DRAWINGS
The annexed drawings show schematically and as an example a form
of execution and variant of the safety syringes according to the
invention.
FIG. 1 illustrates a longitidunal section of the syringe according
to the invention in its position before use, during storage.
FIG. 2 illustrates a longitudinal section of a standard needle
in its protection cap, intended to be fixed onto the distal end
of the needle carrier by push-fit.
FIG. 3 illustrates the coupling of the needle carrier onto the
plunger.
FIG. 4 illustrates a longitudinal section of the syringe at the
end of its stroke, the cursor having been slid back to allow the
needle carrier to be retracted with its needle inside the cylinder.
FIG. 5 illustrates the needle carrier and its needle retracted
inside the barrel.
FIG. 6 illustrates a variant of the distal extremity of the syringe,
particularly of the plunger, rendering the syringe automatically
non-reusable after a single use.
DETAILED DESCRIPTION OF THE INVENTION
The safety syringe illustrated particularly in FIG. 1 constitutes
a barrel 1 moulded by injection of, for example, transparent polypropylene.
This barrel 1 has a length and a diameter which depend on the capacity
of the syringe, of its ease of use and other normal features such
as the length of the standard needles.
This barrel 1 of the syringe has at its proximal extremity a flange
2 moulded integrally with the barrel, but of a larger diameter or
having a lengthened shape in plan view.
The syringe consists further of a plunger having a shaft 3 of which
the proximal extremity which emerges out of the barrel 1 has a push-button.
The plunger head 4 situated at the distal extremity of shaft 3 includes
a housing 5 to hold an O-ring 6 which slides in a watertight fashion
within the barrel 1.
The use of an O-ring to ensure the watertightness between the plunger
and the barrel is advantageous because this type of joint costs
less than a full piston head moulded in rubber; furthermore it can
be injection moulded in a synthetic elastomer which meets all medical
requirements.
The distal extremity of the shaft 3 situated beyond the O-ring
6 of the plunger in the direction of the distal extremity of barrel
1 consists of the male organs 8 of a coupling system of the plunger
3-6 with a needle carrier 7. These male coupling organs are formed
by projections 8 extending axially in the direction of the distal
extremity of the barrel 1 these projections 8 being situated around
a circumference centred on the axis of barrel 1 and of which the
radial extension is in the order of 40.degree. to 120.degree. according
to the number of the projections 8. Generally one uses three or
four projections 8 uniformly distributed around the axis of plunger
3-6 and presenting an angular spread included between 45.degree.
and 70.degree.. Each of the projections 8 has at its tip an inclined
plane 9 on its external face widening in the direction of the proximal
extremity of barrel 1 and forming a retaining ridge 10 on the cylindrical
face of the proximal extremity of projection 8. The distal part
11 of barrel 1 presents a smaller diameter extension with an annular
internal stop 12 at its distal extremity formed by a circular brim
facing towards the axis of barrel 1 so as to reduce the distal opening
of barrel 1. This distal part 11 of the barrel has an annular groove
lla situated on its external peripheral surface.
The syringe also includes a needle carrier 7 comprising a distal
end consisting of a hollow cone 13 designed to hold an hypodermic
needle 14 by push-fit. The proximal end 15 of the needle carrier
comprises a cylindrical portion 16 having an external diameter which
corresponds of the internal diameter of the distal extension 11
of barrel 1. This proximal extremity 16 of the needle-carrier 7
slides in a watertight manner inside the distal part of the barrel.
A seal, for example an O-ring, 16a lodged in an annular channel
around the needle-carrier ensures a perfectly watertight fit between
the barrel 1 and the needle-carrier 7. It is possible to retract
the needle-carrier into barrel 1 when it has been freed by sliding
the cursor 21 22. The external diameter of the distal part of needle-carrier
7 does not exceed the diameter of the distal opening of barrel 1.
The median section 17 of this needle-carrier presents a diameter
which corresponds to the internal diameter of the brim situated
at the distal extremity 11 of the barrel. Thus the furthest distal
position of the needle-carrier 7 in the barrel 1 is defined by the
contact of the shoulder separating the proximal part 16 of the median
section 17 of the needle-carrier 7 with the stop 12 of barrel 1.
This median section 17 of needle-carrier 7 has a circular groove
18 with a proximal annular face situated, when the needle-carrier
7 is in its furthest distal position, in the extension of the frontal
face of the rim of the distal extremity 11 of barrel 1.
In the standby or storage position of the syringe illustrated in
FIG. 1 the needle-carrier 7 is lodged in the distal part 11 of
barrel 1.
On part of its internal circumference, about 60.degree. to 120.degree.,
the proximal portion 16 of the needle-carrier 8 includes a ridge
or catch 19 which constitutes the female part of the coupling of
the plunger into the needle-carrier intended to cooperate, as we
shall see later, with the catch 10 of the tip of at least one of
the fingers 8 of the plunger.
The coupling comprised by the catches 10 of one or two fingers
8 and the catch 19 of the needle-carrier 7 is unlockable. It thus
possible to re-lock together the plunger and the needle-carrier
after these have already been locked together once, and the needle
can then still be pulled inside the barrel 1 after use as soon as
the user has slid back the cursor 22 and thus freed the needle-carrier
7.
In its initial position during storage (FIG. 1) an operator can
push-fit a needle 14 onto the distal projection 13 of the needle-carrier
7 and also change the needle as required, in the same way as is
done with conventual syringes. The needle carrier 7 is locked in
this position in relation to the barrel 1 by a cursor. This cursor
consists of a ring 21-22 sliding freely around the barrel. This
ring 21 has at least one flexible locking finger 22 extending in
the direction of the distal tip of the barrel 1. In its operational
position (FIG. 1), the cursor is in its distal position and the
ends of its fingers 22 are lodged in groove 18 of the needle-carrier
7. Thus the needle-carrier 7 is locked in its service position and
cannot be pulled out or pushed into the barrel for example during
needle fixing, aspiring a liquid from a bottle or administering
an injection.
This cursor is transparent and in no way interferes with visibility
when filling the syringe.
The operator can then carry out all necessary clinical requirements;
aspire a liquid and inject it into a patient, or sample blood from
a patient's vein and empty it into a test tube using traditional
manipulations.
When the operator has finished and wishes to dispose of the syringe,
the operator must never cap the needle nor discard the naked needle,
which always presents a great potential danger of needlestick injury,
but at the end of the injection stroke a slightly firmer pressure
is applied to the plunger thus causing the coupling together of
the plunger and the needle-carrier, the catch 10 of fingers 8 locking
by elastic deformation of the fingers 8 onto the catch 19 of the
needle-carrier 7 as shown in FIG. 4.
As long as the cursor 21-22 remains in its distal service position,
the plunger 4 can still be unlocked from the needle-carrier 7. This
is important because this coupling at the end of the distal stroke
of the plunger can sometimes happen unintentionally.
Before pulling the needle-carrier 7 inside the barrel 1 by means
of the plunger, the user must unlock the needle-carrier 7 by sliding
the cursor 21-22 in a proximal direction along barrel 1 which pulls
the fingers 22 out of the groove 18 of the needle-carrier 7 which
fingers 22 can then be parked in the annular external depression
lla around the barrel.
From this moment, the plunger and the needle-carrier are coupled
together and, after having slid back the cursor 21-22 to free the
needle-carrier, in withdrawing the plunger one withdraws the needle-carrier
7 and its needle 14 inside the barrel 1 (FIG. 5).
Because of the flexibility of the fingers 8 and that only one or
two of these are coupled with catch 19 of the needle carrier 7
this latter is inclined in relation to the axis of the barrel (FIG.
5) so that when the plunger has been sufficiently retracted, the
needle can no longer emerge from the barrel.
The proximal extremity of the barrel 1 contains an internal stop
ring 23 with an inclined ramp which allows the plunger to be inserted
into the barrel 1 but which stop ring blocks its being pulled out.
Thus, the operator cannot pull the needle out of the barrel through
its proximal opening and the used needle is irrevocably interred
inside the barrel 1. This stop ring is considerably more prominent
than the stop rings normally included in standard syringes where
the plunger can easily be removed from the barrel through its proximal
opening.
In a variant, the plunger shaft can have a Y-section instead of
an X-section. This can provide an economy of around 25% of plastic
used for this part while still providing it with sufficient rigidity.
By this means the manufacturing cost of these syringes can be reduced.
The principal advantages of this safety syringe are:
1. It will eliminate any possibility for healthcare personnel to
suffer accidental needlestick injury with an infected needle, after
having administered an injection.
2. It's mode of use (filling/injection) remains exactly the same
as the existing procedure for use with standard syringes.
3. To render it totally non-reusable, it is merely necessary to
push the plunger to the limit of its stroke, which couples the distal
tip of the plunger into the needle carrier. The needle is then withdrawn
by the plunger, after the cursor has been slid back, inside the
barrel where it is blocked.
4. The needle having by these actions been inclined and pressed
against the interior of the barrel, it cannot by any means re-emerge
through the distal opening of the barrel. Because of the stop ring
23 it furthermore cannot be pulled out of the barrel through the
proximal opening.
5. During the push-fitting of a needle onto the needle carrier
and during the entire cycle of use of the syringe, it is impossible
to push the needle carrier inside the the barrel, as it is locked
by the cursor 2122.
6. On the other hand, the coupling with the needle carrier by the
plunger (see 3 above) presents no difficulty.
7. The syringe cannot be reused and can be discarded for incineration
without the slightest danger.
8. Neither hand can approach the dangerous distal zone which can
cause needlestick accidents. One hand is holding the syringe by
its barrel while the other hand is pulling the plunger.
9. It consists of four moulded plastic components, plus two standard
elastomeric seals.
10. It accepts all standard needles and all volumes of the syringe
incorporate the same sized needle carrier.
11. The manufacturing costs are comparable to those of a standard
non-safety single use syringe.
12. The dead volume at the end of an injection is within the ISO
international standards.
FIG. 6 illustres a form of execution of the syringe which is self-destructing,
in other words once it has been used it can no longer be used, even
intentionally.
To realise this, the distal tip of the plunger shaft has a passage
30 connecting the spaces on barrel 1 situated each side of the watertight
seal 6 of the plunger.
This passage 30 is blocked and rendered watertight by a blocking
means, for example a ball 31 preferably elastomeric, held in position
by an element 32 lodged and held between the fingers 8 which carry
internal rims 33 for this purpose. This element 32 has the characteristic
of having a variable resistance to compression depending on whether
it is dry or wet. In its dry state it is hard and presses the ball
31 strongly against its seating, thus blocking the passage 30.
As soon as the syringe has been filled with the liquid the element
32 has its mechanical resistance diminished. Thus, while the user
empties the liquid contained in the syringe, ball 31 is constantly
pressed against its seating, the pressure applying in the distal
chamber of barrel 1 being greater than that applying in the proximal
chamber of said barrel.
On the other hand, if the user wishes to refill the syringe he
must, to aspire the liquid through the needle, pull back the plunger
which causes a depression in the distal chamber of the barrel. At
this moment, ball 31 moves by deforming element 32 which is now
soft and it is air that fills the distal chamber of the barrel,
which is now unable to be filled with a liquid.
It is evident that in this second form of execution the user can
equally well push the plunger to the limit of its stroke in the
barrel and to definitely couple this to the needle-carrier then
pull the needle-carrier and the needle it is carrying inside the
barrel so as to then discard the syringe in perfect safety.
Thus, this variant, in addition to the advantages of the first
version of the syringe that has been described, is self-destructing;
it cannot be re-used, even intentionally.
In another variant and with the aim of reducing even more the amount
of plastic required for manufacture of the syringe, it is possible
to mould the finger-grip flange 2 not at the proximal extremity
of the barrel 1 but at a distance of 1 to 2 cm from this proximal
extremity of the barrel. In so doing, it is thus possible to shorten
the length of the plunger shaft 3 advancing the position of its
push-button (2) to abut, when the plunger head 4 has been pushed
to the limit of its stroke inside the barrel, against the opening
of the barrel at its proximal extremity, without affecting the ease
of manipulation of the plunger. |