Safety syringe abstract
A safety syringe is formed of an inner sleeve receiving a cartridge
with liquid, an outer sleeve through which said inner sleeve is
telescopically reciprocated, and a plunger assembly that is attached
to the inner sleeve and used to eject the liquid. The needle is
mounted on a front end of the inner sleeve and in a retracted position
is wholly contained within the outer sleeve while in a protracted
position the needle is exposed so that it can be used for an injection.
Advantageously, in one embodiment, the inner sleeves can rotate
with respect to each other causing the needle to rotate both when
the needle is extended and when is retracted into the outer sleeve.
Another feature of the invention is that in one embodiment the inner
sleeve has an internal puncture member for puncturing the cartridge.
Therefore, instead of a dental needle with two sharp tips, a standard
needle with a single tip and a Luer connection may be used.
Safety syringe claims
I claim:
1. A safety syringe comprising: a plunger assembly including a
rod; an inner sleeve sized and shaped to receive a cartridge with
liquid and said plunger assembly, said plunger assembly being adapted
to force the liquid from said cartridge when said rod is moved with
respect to said inner sleeve, said inner sleeve having a front end
adapted to receive a needle, said needle being in communication
with said cartridge to receive said liquid; an outer sleeve telescopically
receiving said inner sleeve; and a stop mechanism adapted to permanently
retain said inner sleeve within said outer sleeve while allowing
said inner sleeve to slide telescopically within said outer sleeve.
2. The safety syringe of claim 1 further comprising a first intermittent
lock means for locking said inner and outer sleeves in a first position
and a second intermittent lock means for locking said inner and
outer sleeve in a second position, said sleeves being prevented
from moving telescopically with respect to each other when one of
said first and second lock means is active.
3. The safety syringe of claim 2 wherein said lock means includes
a pivoting lever disposed on said outer sleeve and respective first
and second lever engagement members associated with said inner sleeve.
4. The safety syringe of claim 1 wherein said outer sleeve is formed
with a circumferential collar.
5. The safety syringe of claim 4 wherein said rod further includes
a finger ring, said finger ring cooperating with said collar to
cause said rod to eject liquid from said cartridge through said
needle when said finger ring and collar are manually squeezed together.
6. The safety ring of claim 1 wherein said rod has a rod end received
in said cartridge for ejecting said liquid, and at least O-ring
mounted on said rod end and arranged to stabilize said rod end as
it reciprocates through said cartridge.
7. A safety syringe comprising: a plunger assembly including a
rod; an inner sleeve with a front end adapted to receive a needle
and a rear end with a mouth for receiving a cartridge with a liquid,
said liquid being ejected through said needle when said rod is inserted
into said cartridge within said inner sleeve; an outer sleeve cooperating
with said inner sleeve to define a retracted and a protracted position,
wherein said needle is exposed in said protracted position and is
fully contained within said outer sleeve in said retracted position;
an actuating mechanism telescopically and selectively moving said
inner sleeve with respect to said outer sleeve between protracted
and retracted positions; and a rotation mechanism simultaneously
rotating said inner and outer sleeves with respect to each other
as said inner and outer sleeves move between said positions, said
needle rotating with said inner sleeve.
8. The syringe of claim 7 further comprising a spring urging said
sleeves toward said protracted position.
9. The syringe of claim 7 further comprising a first lock intermittently
locking said sleeves in said protracted position, and a second lock
intermittently locking said sleeves in said retracted position.
10. The syringe of claim 9 wherein said first and second lock includes
a lever disposed on said outer sleeve and first and second lever
engaging holes formed in said inner sleeve.
11. The syringe of claim 10 further comprising a spring urging
said sleeves toward said retracted position, wherein said sleeves
are moved automatically to said protracted position, when said sleeves
are in said protracted position and said lever is released.
12. The syringe of claim 7 further comprising a permanent lock
that when activated immobilizes said needle within said outer sleeve.
13. The syringe of claim 12 wherein said permanent lock includes
a tab formed on said outer sleeve and a frangible member that deforms
when said tab is pressed to cause said tab to permanently engage
said inner sleeve.
14. A safety syringe comprising: a plunger assembly including a
rod; an inner sleeve with a front end adapted to receive a needle
and a rear end with a mouth for receiving a cartridge with a liquid,
said liquid being ejected through said needle when said rod is inserted
into said cartridge within said inner sleeve; an outer sleeve cooperating
with said inner sleeve to define a retracted and a protracted position,
wherein said needle is exposed in said protracted position and is
fully contained within said outer sleeve in said retracted position;
an actuating mechanism telescopically and selectively moving said
inner sleeve with respect to said outer sleeve between protracted
and retracted positions; and an aspiration mechanism automatically
providing aspiration when said actuating mechanism is released.
15. The syringe of claim 14 wherein said aspiration mechanism includes
a flexible member that urges said cartridge away from said front
end.
16. The syringe of claim 15 wherein said flexible member is coil
spring.
17. The syringe of claim 15 wherein said flexible member is a plastic
member formed integrally in said inner sleeve.
18. The syringe of claim 15 wherein said sleeves are formed with
elongated windows arranged and constructed to allow cartridge removal,
venting and direct viewing of the cartridge contained therein.
19. A safety syringe comprising: a plunger assembly including a
rod; an inner sleeve with a front end adapted to receive a needle
and a rear end with a mouth for receiving a cartridge with a liquid,
said liquid being ejected through said needle when said rod is inserted
into said cartridge within said inner sleeve, said inner sleeve
including an inner member arranged to puncture said cartridge when
said cartridge is inserted into inner sleeve, said inner sleeve
further including a threaded member disposed at said front end to
receive a needle, said threaded member and said puncture member
cooperating to provide liquid from said cartridge to said needle
without said needle extending into said inner sleeve; an outer sleeve
cooperating with said inner sleeve to define a retracted and a protracted
position, wherein said needle is exposed in said protracted position
and is fully contained within said outer sleeve in said retracted
position; and an actuating mechanism telescopically and selectively
moving said inner sleeve with respect to said outer sleeve between
protracted and retracted positions.
20. The syringe of claim 19 wherein said puncture member is a hollow
spike.
21. The syringe of claim 19 wherein said threaded member is a Luer
lock adapted to accept a needle with matching Luer connector.
Safety syringe description
RELATED APPLICATIONS
[0001] This application is a continuation-in-part of patent application
Ser. No. 10/209415 filed Jul. 31 2002 which is a divisional application
of patent application Ser. No. 09/506484 filed Feb. 17 2000 (now
U.S. Pat. No. 6428517 issued Aug. 6 2002) and which claimed priority
to provisional applications Ser. No. 60/133397 filed May 10 1999
and Ser. No. 60/173374 filed Dec. 28 1999 all incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] A. Field of Invention
[0003] This invention pertains to a syringe used to inject a therapeutic
fluid into human or animal tissues, and more particularly to a syringe
that includes a needle movable along a longitudinal axis, which
needle is optionally rotating about said axis as well. Importantly,
prior to and immediately after the injection, the needle is disposed
in a protective sleeve that prevents needle sticks. Preferably,
after an injection is completed, a permanent locking mechanism is
activated to trap the needle within the sleeve.
[0004] B. Description of the Prior Art
[0005] Traditional dental syringes are metal and designed to accommodate
a double-ended needle on the threaded hub of the syringe. A pre-filled
glass local anesthetic cartridge fits in the barrel of the syringe.
The cartridge is pierced by a sharp working end of the needle that
projects into the barrel of the syringe penetrating the diaphragm
of the cartridge. It is often necessary for the dentist or other
health care provider to provide multiple injections for a single
patient throughout a dental procedure or appointment. The standard
practice is to recap the needle after initial injection and then
uncap and reuse the same needle on the one patient for subsequent
injections. Frequently, the cartridge is changed, but the needle
is rarely changed for a single patient. In certain situations however,
the replacement of a needle may be necessary do to dulling of needle
or the need for a different needle length or gauge. This then requires
the removal and replacement of the needle. To accomplish this, the
user recaps the needle, typically using a one-handed scoop technique
or adaptive needle cap holder or add-on shield. The user must still
manually manipulate the needle when removing it from the syringe,
thus exposing the sharp end that protrudes into the anesthetic cartridge.
This procedure provides a risk of percutaneous injury to users when
handling anesthetic needles.
[0006] An important goal of dentistry and medicine in general is
to insure that during any procedure involving interaction between
a dentist or other care giver and a patient, utmost care is taken
to protect the care giver from injury and/or infection with diseases.
It has been recognized that the use of hypodermic needles, which
activity is endemic in the field, is one particularly hazardous
area. More particularly, the use of a hypodermic needle in dentistry
and other medical fields has been shown to put the user at risk
to inadvertent needle sticks, and presents a potential high risk
to infection disease transmission for health care workers.
[0007] The use of hollow-core needles is the standard in drug delivery
in medicine and dentistry. The use of the hollow-core needle dates
back over 150 years when Charles Pravaz, a French general surgeon,
patented such a device.
[0008] Currently several auto-retraction type syringes are known
that provide increased safety by allowing the protruding needle.about.to
be retracted into a protective sheath after use. However, these
systems where found to be unsatisfactory by the health care provider
community. Other syringes are provided with removal caps. Some prior
art syringes and needles with protectors are disclosed in the following
U.S. patents: U.S. Pat. Nos. 5120310; 5188613; 5267961; 5389076;
5423758; 5578011; 5632733; 5637092; 5810775; 5030209;
4911693; 4900310; 4813426; 4795432; 4664654; 4695274;
4966592; 4747831; 4900311; 5411487; 5106379; 5713873.
[0009] Other systems are also known (e.g., U.S. Patent Application
Publications 2002/0169421 and 2002/0068921 published Nov. 14 2002
and Jun. 6 2002 respectively) and U.S. Pat. Nos. 5207646 and
6413236. However, these systems are awkward to use and explicitly
describes means for preventing needle rotation.
[0010] Generally, these prior art references have either one or
more of the following deficiencies.
[0011] 1) Hollow core needle that is rigidly affixed to the end
of a syringe-, tubing or handle. The protruding needle presents
a risk of inadvertent needle stick to the operator.
[0012] 2) Existing auto-retracting syringes are difficult to use
[0013] 3) Cannot be locked permanently to prevent reuse.
[0014] In the past 15 years regulatory agencies such as OSHA have
attempted to improve the use and safety of needles in the health
care industry. With the rise of infectious diseases, i.e., hepatitis
and AIDS, protection of the health care workers has become a needed
priority. It is supported in the medical/dental literature that
inadvertent needle sticks represents a significant risk to our health
care providers.
[0015] The proposed invention has been designed to eliminate the
potential of inadvertent needle sticks after and during use.
[0016] For example, various medical organizations have suggested
and several states have instituted rules for the protection of care
givers while providing injections to patients. More specifically,
rules have been promulgated requiring that injection needles on
syringes be provided which can be easily removed prior to an injection
and re-installed immediately after an injection.
[0017] Another related problem addressed by the present invention
pertains to the deflection or bending of needles as they are inserted
into the tissues of a patient. This deformation occurs because the
needle is usually flexible because of its relatively small cross-sectional
area and cannot resist effectively the axial and radial forces present
during the insertion. This deflection is undesirable because it
provides additional resistance during the insertion, to the movement
of the needle and/or syringe, makes it difficult to guide the needle
to a particular site preselected by the care giver. Moreover, if
a needle is deflected, bent or otherwise deformed during insertion,
it may cause more paint to the patient, trauma to the local tissues
and other undesirable effect. It has been discovered (as disclosed
in co-pending patent application Ser. No. 60/173374 filed Dec.
28 1999), incorporated herein by reference, that these disadvantages
are eliminated or at least alleviated if the needle is rotated about
its longitudinally about its axis as it is advanced along the axis
into the patient tissues. Other syringes do not allow the use of
a rotational insertion and removal technique to be used during a
power assisted injection process.
SUMMARY OF THE INVENTION
[0018] This syringe described herein overcomes the known disadvantages
of existing syringes. It is a capable of both intermittent locking
during use as well as permanent locking after use. In addition,
an optional design configuration utilizes a single ended medical
Luer-lock needle in combination with a standard local anesthetic
cartridge enhancing the safety to the operator. An additional benefit
of this device is an innovative design element in the barrel of
the syringe that guides the needle into translation/rotation during
injection, resulting in the reduction of force needed to penetrate
the patient's tissue and also reduces needle deflection. Needle
deflection in local anesthetic injections has been associated with
increased failure rates. This same feature of simultaneous rotation/translation
of needle will also result in a reduced amount of force to remove
the needle from the patients' tissues, once again aiding in the
safety and comfort to both the operator and patient. An auto-aspiration
design is an innovative safety element in one of the potential designs
of this device. The inclusion of this feature ensures greater safety
for patients during the use of this device. Currently, no dental
syringe is available with these features.
[0019] Because of the potential for nerve damage during dental
anesthetic injections, it is desirable to have proper aspiration
during certain injections. This helps prevent damage that may result
in permanent loss of feeling and function in areas of the mouth,
tongue and lip.
[0020] Because of its design, the subject syringe can be manufactured
with fewer components then other syringes currently available in
the marketplace.
[0021] Briefly, a safety syringe constructed in accordance with
this invention includes two telescoping sleeves and a plunger assembly.
Means are provided to selectively interlock the two sleeves in either
a protracted and a retracted position. A cartridge filled with a
liquid is disposed in the inner sleeve and is in fluid communication
with a needle coupled to the inner sleeve. A user can advance the
needle out of the outer sleeve . Preferably, as the needle is advanced
it is rotated about its longitudinal axis at the same time for an
angle of between 25 and 270 degrees. In one embodiment, the liquid
is expressed as the needle is moving and rotating forward. In another
embodiment the needle is advanced and rotated until it reaches the
protracted position, and then the liquid is injected. In either
case, at the end of the injection, the inner sleeve is withdrawn
from the outer sleeve causing the needle to rotate as it retracted
into the outer sleeve.
[0022] Once the needle is retracted into the second sleeve means
provided on the outer sleeve are used to permanently capture the
needle so that it cannot be removed.
[0023] In an alternate embodiment, means are provided that selectively
urge the cartridge away from the needle thereby providing aspiration.
[0024] In an alternate embodiment, means are provided to puncture
a membrane on the cartridge to provide access for the liquid. In
this embodiment, a single ended standard medical needle can be used
instead of a dental needle that possess a double ended needle with
two sharp points.
BRIEF DESCRIPTION OF THE FIGURES
[0025] FIG. 1 shows an orthogonal blown up view of a syringe constructed
in accordance with this invention;
[0026] FIG. 2 shows an orthogonal view of the syringe of FIG. 1
with the needle protracted;
[0027] FIG. 3 shows an orthogonal view of the syringe of FIG. 1
with the needle extended;
[0028] FIG. 4 shows a side view of the push rod for the syringe
of FIGS. 1-3;
[0029] FIG. 5 shows a side view of the push rod guide cap for the
syringe of FIGS. 1-3;
[0030] FIGS. 6 and 6A show a side view of the inner sleeve for
the syringe of FIGS. 1-3;
[0031] FIG. 7 shows a side view of the outer sleeve for the syringe
of FIGS. 1-3;
[0032] FIG. 8 shows an enlarged partial cross-sectional view of
outer sleeve of FIG. 7;
[0033] FIG. 8A shows a second enlarged partial cross-sectional
view of the syringe taken along lines 8A-8A in FIG. 7;
[0034] FIG. 8B shows an enlarged partial top view of the outer
sleeve of FIG. 7;
[0035] FIG. 9 shows an enlarged partial cross-sectional view of
the syringe of FIGS. 1-3 with the inner sleeve being pushed into
the outer sleeve;
[0036] FIG. 10 shows a cross-sectional view of the syringe in the
protracted position;
[0037] FIG. 11 shows a partial cross-sectional view of the inner
sleeve with a rim providing aspiration;
[0038] FIG. 12 shows a partial cross-sectional view of the inner
sleeve with a coil spring providing aspiration; and
[0039] FIG. 13 shows a partial cross-sectional view of the inner
sleeve with integral flexible fingers providing aspiration.
DETAILED DESCRIPTION OF THE INVENTION
[0040] Referring first to FIGS. 1-10 a safety syringe 10 constructed
in accordance with this invention includes a plunger assembly 12
an inner sleeve 14 and an outer sleeve 16 terminating at its distal
end with an aperture 20. Briefly, a cartridge 18 filled with a desired
liquid is inserted into the inner sleeve 14 and the inner sleeve
14 is the closed by inserting therein an end of the plunger assembly
12. A coil spring 22 is positioned on one end of the inner sleeve
12 a standard dental needle assembly 24 having a needle tip 25
is attached to the inner sleeve as shown in FIG. 2. The syringe
10 is then operated by forcing the inner sleeve 12 and its cartridge
18 through the outer sleeve 14 so that a portion of the needle assembly
24 exits through aperture 20. As the needle assembly exits through
the aperture, the liquid within the cartridge is expressed through
the needle and therefore the injection may be started as soon as
the needle tip appears through the aperture. Preferably, as the
needle tip 25 is advancing toward its final position shown in FIG.
3 it is simultaneously rotated about its longitudinal axis.
[0041] After the injection is complete, the inner sleeve can be
released and the coil spring 22 causes the needle assembly 24 to
be rapidly withdrawn into the outer sleeve 14. The syringe can be
reused, or alternatively, a permanent lock mechanism can be activated
to trap the needle assembly 24 within the outer sleeve 16. The whole
syringe 10 can then be discarded safely since the needle tip 25
is not exposed. Details of the syringe elements and how they interact
to provide the described functions are provided below.
[0042] The plunger assembly 12 consists of an elongated push rod
30 (shown in FIG. 4) and a guide cap 40 (shown in FIG. 5). Push
rod 30 has a shaft 31 attached at one end to a finger ring 32 or
other similar means for engaging the thumb or finger of a health
care provider. At the opposite end, shaft 31 has a reduced diameter
portion 33 formed with preferably two O-rings 34. The end face 36
may be provided with a hook or a barb 37. The two O-ring design
is somewhat preferable because it provides a suitable frictional
grip and therereby the following advantages:
[0043] 1. Two O-ring design allows the plunger to be properly stabilized
within the anesthetic cartridge at two axially spaced contact points
within the glass cartridge. With a single O-ring design the plunger
may pivot within the inner surface of the glass cartridge making
the plunger unstable during use.
[0044] 2. The two O-ring design provides increased frictional drag
of the plunger as it is moved within the glass cartridge. This serves
2 additional important purposes:
[0045] a. The increased drag of the two O-rings ensures a slower
rate of delivery because of the increased friction force encountered
against the glass cartridge while depressing the plunger thus ensuring
that the anesthetic solution will be expressed at a slower rate
producing a more comfortable injection for the patient. It is well
documented in the dental and medical literature that a slower injection
is a more comfortable injection for the patient.
[0046] b. The increased drag of the two O-ring design enables the
glass cartridge to be removed simultaneously with the plunger assembly
as the plunger assembly is disconnected or withdrawn from the inner
cylinder. This can add in the efficiency of removal or replacing
the cartridge at the end of the injection.
[0047] The design of the plunger is not limited to a two o-ring
design and may use more or less number of O-rings to accomplish
the same objectives. It is also conceivable that another type of
"gasket component" could be used such as a flexible collar
that is made from a soft material such as silicone, but not limited
to silicone, to achieve a similar outcome.
[0048] Between its two ends, rod 30 supports the push rod cap 40
shown in more detail in FIG. 5. The cap 40 is formed with a short
sleeve 41 formed with two snap tabs 42. Cap 40 can be glued to the
rod 30 can be held in place by two O-rings (not shown) or the push
rod 30 and the cap 40 can be molded unitarily.
[0049] As discussed above, the cartridge 18 holds a desired liquid
such as an anesthetic. Typically, such a cartridge has a cylindrical
glass or plastic sidewall 44 (FIG. 1), with a rubber piston 38 at
one end, and a rubber membrane 46 encased in a metal sheath at the
other end.
[0050] The inner sleeve 14 shown in detail in FIGS. 6 and 6A is
formed with a cylindrical sidewall 48 with an open mouth 50A at
one end, and a closure 50 at the other end. The closure 50 includes
a shoulder 52 surrounding a hub 54. The cylindrical wall 48 is formed
with one or more elongated (preferably two) windows 56. In addition,
the wall 48 with two similarly shaped transversal openings 58A,
58B, one near each end of sleeve 14. The two openings 58A, 58B are
angularly offset from each other. The sleeve 14 is further provided
with two additional openings or depressions 60 spaced peripherally
about wall 48 preferably opposite to each other. These openings
60 are formed with a flexible tongue 60A. As seen in FIG. 6A, the
tongues 60A are formed so that their ends normally extend outwardly
of the surface 48. Between openings or depressions 60 there is butterfly-shaped
opening 61. Wall 48 is also formed with a pin 62.
[0051] Referring to FIGS. 7 8 and 8A, the outer sleeve 16 is
formed with a cylindrical outer wall 70 with a mouth 72 at one end
and opening 20 at the other. A finger collar 74 is formed around
mouth 72 having about the same diameter as the push rod cap 40.
Adjacent to collar 74 there is a control lever 76. The control lever
76 includes a curved arm 78 shaped and sized to be operated with
a finger (like the trigger of a pistol) and a tong 80 extending
inside the outer sleeve 16. The control lever 76 is preferably molded
unitarily with the outer wall 70 and collar 74 in such a manner
that it can be slightly pivoted when pulled by a finger as indicated
by arrow A to cause the tong 80A to rise outwardly of the sleeve
14 as indicated by arrow B. When the arm 78 is released, the tong
moves back to the position show in FIG. 8. As seen in FIGS. 7 and
8B, axially spaced from the control lever 76 there is a tab 80.
This tab 80 is supported by a frangible strip 82 attached to the
sidewall 70 and includes a tooth 84 extending into the sleeve 16.
Two or more tabs 80 may also be provided.
[0052] Optionally, the sidewall 70 can be formed with two elongated
windows windows 56A having generally the same size and shape as
windows 56 on the inner sleeve. The purpose of the two sets of coinciding
windows 56 56A is as follows:
[0053] 1. The oral cavity is a moist and humid environment and
it is possible that the humidity encountered by the device may result
in a fogging effect of the materials used thus hampering the ability
of the user to see the cartridge 18 contained within the syringe
assembly 10. However, in some instances (for example, aspiration)
it is important that user be able to see the contents of the cartridge
18. The two set of elongated windows 56 56A are conincident to
ensures that proper ventilation is provided to prevent the fogging
or clouding when being used.
[0054] 2. In addition, the windows allows the sleeves to be molded
of a material that is not translucent and is relatively opaque but
still enables the user to see cartridge 18
[0055] 3. The windows may be used to remove the cartridge from
the sleeve 14.
[0056] Advantageously, sleeve 16 also includes two fingers 86.
Each finger 86 includes a respective inwardly extending projection
88 as shown in FIGS. 8A and 8B.
[0057] The sleeve 16 also includes a helical channel 90. The channel
is disposed on the inner surface of sleeve 16 and is sized and shaped
to receive pin 62. Preferably, the sleeve 18 includes a rib 92 forming
channel 90 although, if the sleeve 16 is thick enough, rib 92 may
not be necessary. The sleeve 16 is preferably made from a molded
plastic material.
[0058] Returning to FIGS. 1-3 initially, the syringe 10 may be
supplied in two parts: sleeves 14 and 16 form one part, the plunger
assembly 12 forms another part and the health care provider supplies
the needle and the cartridge. The sleeve 14 is disposed in the protracted
position of FIG. 3 so that it is essentially all the way inside
sleeve 16. The two sleeve are being biased by the spring 22 is compressed
between the two sleeves, however they are maintained in this protracted
position by the tongue 80A being disposed in hole 58A and thereby
engaging the inner sleeve.
[0059] A user applies an injection to a patient using the syringe
10 as follows. First, he attaches an appropriate needle 24 by mounting
on hub 54. In this position, the needle tip 25 extends outwardly,
as shown in FIG. 2 while the inner needle end 25A extends inside
the sleeve 14. Next, the user pulls the lever 76 causing the tongue
80A to disengage from the sleeve 14. As a result, the spring 22
causes the sleeve 14 outward to the retracted position and shifting
the needle into the sleeve 16 so that it is no longer exposed. Sleeve
14 moves back until the tongues 60A come into contact with the inwardly
extending projections 88 on fingers 86. Thus, tongues 60A, fingers
86 and projections 88 are slightly flexible to allow the sleeve
14 to be inserted into sleeve 16 but once the sleeve 14 is inserted,
these elements cooperate to form a stop that prevents the sleeve
14 to be removed from sleeve 16. Moreover, the control lever 76
also engages the sides of opening 58B thereby capturing sleeve 14
in the retracted position.
[0060] Next, the user inserts a cartridge 18 into sleeve 14. The
user pushes the cartridge all the way, causing the needle end 25A
to penetrate the membrane 46 and is immersed in the liquid contained
therein.
[0061] Next, the user inserts the plunger assembly into the sleeves.
More particularly, he pushes the rod 30 into the sleeve 14. The
rod 30 and the sleeve 14 are dimensioned so that as the end 36 of
rod 30 comes into contact with the piston 38 the inner surface
of the sleeve 14 telescopically fits over short sleeve 41 and a
frictional engagement is created between the sleeve 14 and the snap
tabs 42. The assembled syringe is shown in FIGS. 2 and 8. If the
rod 30 has a barb 37 the barb penetrates and engages the piston
38.
[0062] The syringe could be used in two modes. In one mode, the
user holds the syringe with the thumb extending through ring 32
and two fingers trained around finger collar 74. One finger is used
to release the sleeve 14 by pushing control lever 76. The user then
squeezes the syringe between his fingers and thumb together in a
normal fashion. As the user is squeezing the syringe three events
occur simultaneously. First, the piston 38 is pushed by rod 30 into
the cartridge 18 causing the liquid to be expressed through needle
25. Second, the sleeve 14 with cartridge 18 starts moving forward
so that the needle starts extending outwardly of aperture 20. Once
a substantial portion of the needle tip 25A is visible, the injection
can be started. Third, as discussed above, the pin 62 is disposed
in groove 90 so that as the sleeve 14 advances through sleeve 16
groove 90 forces the sleeve 14 and needle 24 through pin 62 to rotated
about their common longitudinal axis. In other words, the needle
24 is translated and rotated simultaneously while the liquid is
ejected and injected. This composite motion continues until the
sleeve 14 reaches it initial protracted position. At this position,
the control lever 76 again engages the sleeve 14 through opening
58A. FIG. 9 shows an intermediate position with the plunger assembly
12 and sleeve 14 advancing, and FIG. 10 shows the syringe during
this final, intermediate locked position. Once this position is
reached, the user can just continue injecting the patient. As disclosed
in my earlier applications, this three-fold action is very advantageous
because it reduces the pain normally associated with the injection,
reduces tissue damage, and so forth.
[0063] Once the injection is complete, the user stops squeezing
the syringe and activates the control lever 76 again. Once again,
the needle 24 jumps back into the outer sleeve. Because pin 62 still
engages groove 90 during this motion, the needle is still caused
to translate and rotate simultaneously thereby reducing pain and
trauma, and also reducing unnecessary tissue damage. The user can
now remove the plunger assembly and the spent cartridge, replace
the cartridge in the inner sleeve and start a new injection. This
operation is facilitated by the fact that there are one or more
(preferably two) O-rings 34 engage the sidewall of the cartridge
and stabilize the plunger assembly as it is being withdrawn from
the inner sleeve, and when the plunger assembly is removed, the
cartridge is pulled out and discarded at the same time. However,
if it becomes too difficult to remove the cartridge, the user can
remove the cartridge by hand by pushing it axially through windows
56.
[0064] After the injection is completed, the plunger assembly is
discarded together with the spent cartridge. As discussed above,
the control lever 76 is used to selectively and temporarily lock
sleeve 14 in either the retracted or protracted positions. However,
recently some authorities have recommended or mandated that the
needle should be immobilized after one use so that it and the syringe
cannot be reused. In the present invention, after the sleeve 14
is pushed into the retracted position, tab 80 is pushed inward causing
it to bend and engage the sidewalls of hole 61. The frangible strip
82 is permanently deformed by this action so that it is no longer
flexible and cannot be used to retract tab 80. This tab 80 permanently
engages hole 61 and does not allow the sleeve 14 to be shifted or
removed from sleeve 16. In this manner, the needle 24 is captured
within sleeve 16.
[0065] In a second mode of operation, the user first squeezes the
push rod cap 40 and the finger collar 74 together. This action causes
the inner sleeve to move into the outer sleeve, as described above,
without the liquid being injected. When the inner sleeve reaches
the Protracted position (FIG. 3), the needle can then be inserted
into a patient tissue and liquid can be injected in the normal manner.
After the injection is completed, the needle can be retracted into
the outer sleeve, as described above.
[0066] In some instances, it may be recommended that the syringe
be aspirated at the beginning of the injection. For this purpose,
in one embodiment of the invention, shown in FIG. 11 the inner
sleeve is provided with an annular rim 96 on the end wall of sleeve
14 positioned adjacent to the membrane 46. During injection, the
cartridge 18 is pushed forward so that the membrane 16 bears against
rim 96. The membrane is soft and resilient and therefore it is deformed
by the rim 96. If aspiration is desired, the user releases the finger
ring and the rim pushes the membrane 46 and cartridge 18 toward
the right, away from needle 24. This action causes the syringe to
aspirate some blood or other body fluid. When injection is resumed,
the membrane 46 is pushed back, against the rim 96. In an alternate
embodiment of the invention, instead of, or in addition to the rim
96 the sleeve 14 is provided with a coil spring 96A. Again, if
the finger ring 32 is released, the spring 96A causes the cartridge
18 to pull back and aspirate. In another embodiment shown in FIG.
13 the inner sleeve 14 is formed or molded with integral flexible
fingers 96B on its inner wall as shown. The fingers 96B are bent
forward by the cartridge 18 while the plunger assembly is advanced.
When the plunger assembly is released, the fingers spring back,
causing the cartridge to move backwards, away from front end of
the inner sleeve 12.
[0067] In another advantageous embodiment shown in FIG. 12 the
sleeve 14 is provided on its end wall with a hollow spike 98. The
spike is sized and shaped to penetrate the membrane 46 when the
cartridge 18 is pushed into the sleeve 14. The inner lumen of the
spike is in communication with the hub 54. In this embodiment, instead
of using a dental needle with two needle tips, a needle assembly
27 can be used with a single hollow needle 27A that receives the
liquid from cartridge 18 through spike 98. Again, the needle assembly
27 is provided with a Luer lock so that it can be readily mounted
onto the hub 54. Thus, the needle 24 could be a standard needle.
[0068] While it is preferable to have the needle rotate as it is
advanced out of the outer sleeve and retracted back into the outer
sleeve, obviously safety syringe can be modified to eliminate this
rotation, for example, by omitting the pin 72 the groove 90 or
both.
[0069] Obviously, the safety syringe provides numerous advantages
not found in the prior art. More specifically, the safety syringe
prevents or at least reduces the sharps injuries from exposed needles.
Moreover, by reducing or eliminating exposure to sharp needles,
the safety syringe also reduces the risk to exposure to blood and
other potentially infections substances. The syringe meets the requirements
set forth for this purpose by various state and federal agencies
for preventing sharps injuries and exposure to potentially contaminated
or infectious substances.
[0070] The syringe is highly innovative and includes many desirable
characteristics not currently available in other syringes, in the
dental or medical market place. These features include a smaller
and compact size, one-handed operation from a single position on
the device, reduced needle insertion force, reduced needle deflection,
integrated aspiration function, selectively intermittent or permanent
locking the needle within the syringe. These features provide the
following advantages:
[0071] a. The compact design insures that the syringe can be used
by health care providers having various hand-sizes;
[0072] b. One-handed operation insures that that syringe is operated
reliably and consistently;
[0073] c. Multiple injections can be performed on the same patient
safely, without requiring the recaping of the needle in between
injections;
[0074] d. The intermittent locking reduces the risk of accidental
needle stick during normal use;
[0075] e. Permanent locking insures that the needle can be safely
disposed while it is completely encapsulated and captured within
the outer sleeve. |