Safety syringe abstract
A safety syringe 10 includes a generally tubular body 14 having
a needle end 18 and plunger end 22 needle 38 and retractable needle
seat 30 two-way valve 36 plunger 42 stopper 62 and rear plunger
seal 44. The plunger may be selectively engageable with both the
stopper and the retractable needle seat. During use, the plunger
may be moved to capture the stopper. The user then moves the plunger
and the captured stopper toward the needle end to a displaced position
corresponding to the desired volume of fluid to be withdrawn. A
vacuum is created between the stopper and rear plunger seal, and
helps to draw fluid into the tubular body. At the conclusion of
the patient injection stroke, the plunger engages the needle seat,
and the vacuum between the stopper and rear plunger seal retracts
the needle safely into the tubular body. The two-way valve controls
flow into and out of the body during use.
Safety syringe claims
What is claimed is:
1. A syringe for retracting a needle supported on a needle seat,
comprising: a generally tubular body having a needle end and an
opposing plunger end, the tubular body having a central axis and
an internal throughbore extending between the needle end and the
opposing plunger end, the tubular body receiving the needle seat
therein and having a seat/body retainer at the needle end for axially
initially attaching the needle seat to the generally tubular body;
the needle seat supported on and sealed to the tubular body by the
seat/body retainer when the needle seat is in an initial retained
position, and the needle seat being selectively moveable from the
initial retained position to a needle seat retracted position; a
plunger having a needle seat end positioned within the internal
throughbore of the generally tubular body and an opposing push plate
end positioned external of the generally tubular body, the plunger
being axially moveable relative to the tubular body and within the
throughbore of the tubular body; a stopper selectively moveable
between an initial position in the opposing plunger end of the tubular
body and a displaced position, the stopper axially secured to the
plunger by a plunger/stopper connector and moveable in sealed engagement
within the generally tubular body when moved from the initial position
to the displaced position; a seat/plunger latch for selective engagement
of the needle seat with one of the plunger and the stopper; a rear
plunger seal in sealing engagement between the opposing plunger
end of the tubular body and the plunger for effecting a vacuum chamber
inside of the tubular body between the stopper and the rear plunger
seal; and a two-way normally closed valve for withdrawing fluid
into the tubular body and subsequently expelling fluid from the
tubular body.
2. The syringe as defined in claim 1 wherein the plunger/stopper
connector comprises: a stopper/plunger latch for selectively axially
securing the stopper to the plunger by axial movement of the plunger
with respect to the tubular body.
3. The syringe as defined in claim 2 wherein the stopper is sealingly
secured to the plunger when the stopper/plunger latch is engaged.
4. The syringe as defined in claim 2 wherein the stopper/plunger
latch includes circumferentially spaced protrusions extending radially
outward of a cylindrical surface of the plunger.
5. The syringe as defined in claim 1 wherein the two-way valve
includes a first valve member which is opened in response to fluid
pressure between the needle seat and the stopper for discharging
fluid from the syringe, and a second valve member opened in response
to a vacuum between the needle seat and the stopper for drawing
liquid into the syringe.
6. The syringe as defined in claim 5 wherein the second valve
member seals against the needle seat when closed.
7. The syringe as defined in claim 1 wherein the two-way valve
is secured to the needle seat.
8. The syringe as defined in claim 1 further comprising: graduations
on the tubular body increasing from the plunger end toward the needle
end.
9. The syringe as defined in claim 1 wherein the seat/body retainer
includes a plurality of circumferentially spaced locking tabs each
moveable radially inward in response to the seat/plunger latch to
release from stops on the generally tubular body.
10. The syringe as defined in claim 1 further comprising: a push
plate secured to the push plate end of the plunger for applying
an axial force to the plunger.
11. The syringe as defined in claim 2 wherein: the plunger/stopper
latch includes one of a female connector and a male connector secured
to the plunger and the other of the female connector and the male
connector secured to the stopper; and the seat/plunger latch includes
one of a male connector and a female connector secured to the needle
seat and the other of the male connector and the female connector
secured to the plunger.
12. A method of using a syringe with a needle seat supporting a
needle and sealingly engaged with and retractable into a generally
tubular body having an internal throughbore extending between a
needle end and an opposing plunger end, the method comprising: sealingly
engaging the needle seat with the generally tubular body, the needle
seat being selectively movable from an initial retained position
to a needle seat retracted position; releasably retaining the needle
seat in the initial retained position; positioning the stopper within
the throughbore of the tubular body; positioning the plunger at
least partially within the throughbore of the tubular body; sealingly
engaging a rear plunger seal with the opposing plunger end of the
tubular body and the plunger for effecting a vacuum chamber inside
of the tubular body and between the stopper and the rear plunger
seal; axially connecting the plunger and the stopper; selectively
applying a first axial force to the plunger to move the stopper
from an initial position in the opposing plunger end of the tubular
body to a selected displaced position while the stopper remains
in sealed engagement with the generally tubular body, thereby creating
a vacuum within the tubular body between the stopper and the rear
plunger seal; inserting a needle into a liquid source; withdrawing
a selected volume of liquid from the liquid source through the needle
and into the tubular body between the needle seat and the stopper
and simultaneously moving the stopper from the selected displaced
position to a fluid drawn position; thereafter inserting the needle
into a fluid repository; thereafter applying a second axial force
to the plunger to move the stopper toward the needle end of the
tubular body while discharging liquid from within the tubular body
and simultaneously creating a partial vacuum within the tubular
body between the stopper and the rear plunger seal; engaging a seat/plunger
latch to axially connect the needle seat with one of the plunger
and the stopper; and relaxing the second force to disengage the
needle seat from the generally tubular body and move the plunger
and the connected needle seat from the initial retained position
to the needle seat retracted position.
13. The method as defined in claim 12 further comprising: moving
the plunger to engage a plunger/stopper latch to axially connect
the plunger and the stopper.
14. The method as defined in claim 12 further comprising: releasably
retaining the needle seat in the initial retained position with
a plurality of circumferentially spaced seat/body tabs on the seat
and corresponding stops on the body.
15. The method as defined in claim 12 wherein the needle is inserted
into the liquid source before moving the plunger to the displaced
position, thereby pressurizing the liquid source while the plunger
moves to the displaced position.
16. The method as defined in claim 12 further comprising: providing
a two-way normally closed valve for withdrawing fluid into the tubular
body and subsequently expelling fluid from the tubular body.
17. A method of using a syringe with a needle sealingly supported
on a needle seat, the syringe including a tubular body having an
internal throughbore, the method comprising: sealingly engaging
the needle seat with the generally tubular body, the needle seat
being selectively moveable from an initial retained position to
a needle seat retracted position; positioning a stopper within the
tubular body, the stopper being in sealed engagement with the tubular
body; positioning a plunger at least partially within the throughbore
of the tubular body; sealingly engaging a rear plunger seal with
a plunger end of the tubular body and the plunger for effecting
a vacuum chamber inside of the cylinder body between the stopper
and the rear plunger seal; releasably retaining the needle seat
in the initial retained position; moving the plunger to connect
the plunger with the stopper; thereafter applying a first force
to the plunger to move the stopper from an initial position to a
selected displaced position, thereby creating a vacuum within the
cylinder body between the stopper and the rear plunger seal; withdrawing
a volume of fluid from a fluid source through the needle and into
the cylinder body between the needle seat and the stopper while
simultaneously moving the stopper from the selected displaced position
to a fluid drawn position; thereafter aspirating air from within
the cylinder body through the needle; thereafter inserting the needle
into a fluid repository; thereafter applying a second force to the
plunger for discharging fluid from within the cylinder body through
the needle while creating a vacuum within the cylinder body between
the stopper and the rear plunger seal; engaging a seat/plunger latch
to axially connect the needle seat with the plunger; and relaxing
the second force to disengage the needle seat from the generally
tubular body and move the needle seat and the supported needle to
a needle seat retracted position.
18. The method as defined in claim 17 further comprising: releasably
retaining the needle seat in the initial retained position with
a plurality of circumferentially spaced seat/body tabs on the seat
and corresponding stops on the body.
19. The method as defined in claim 17 wherein the needle is inserted
into the liquid source before moving the plunger to the displaced
position, thereby pressurizing the liquid source while the plunger
moves to the displaced position.
20. The method as defined in claim 17 further comprising: providing
graduations on the tubular body increasing from the plunger end
toward the needle end.
Safety syringe description
FIELD OF THE INVENTION
[0001] The present invention relates generally to syringes and,
more particularly, to syringes having retractable needles. The invention
specifically relates to a disposable syringe which utilizes a vacuum
to automatically retract the needle into the syringe body and thereby
prevent the healthcare practitioner from getting stuck by the needle.
BACKGROUND OF THE INVENTION
[0002] Hypodermic syringes provide an effective, reliable, and
inexpensive way to inject a measured quantity of medicine below
the skin. Syringes typically have exposed needles, however, and
the ease by which a needle may pierce the skin creates a hazard
that the healthcare worker may accidentally be stuck with a needle.
The resulting injury could be as simple as a minor skin laceration,
or as deadly as an infection from a virus in the patient's blood.
[0003] Because syringes are routinely used worldwide, occasional
injuries are inevitable when using conventional syringes. Healthcare
practitioners are exposed to this danger in routine medical practice.
Diabetics, people with arthritis, and others who self-administer
daily injections are at risk, as are members of their household.
After disposal, conventional syringes may continue to pose a risk
to sanitation workers and anyone else who comes in contact with
landfills and waste management processes. Some syringes will undoubtedly
be disposed of or handled improperly prior to disposal, increasing
the chance of injury. Despite their utility, conventional syringes
thus clearly pose a danger to healthcare practitioners.
[0004] The prior art discloses methods of reducing or eliminating
the dangers associated with exposed syringe needles. U.S. Pat. No.
4908022 describes a disposable safety syringe having a retractable
needle. U.S. Pat. No. 5885257 describes a syringe having a spring-loaded,
automatically retractable needle. U.S. Pat. No. 5000736 describes
a syringe having a sealed tubular plunger from which air has been
evacuated and a needle releasably attached to the distal end. After
the patient is injected, the plunger seal is ruptured and the differential
pressure between the vacuum and ambient air causes the needle to
retract safely within the syringe body. U.S. Pat. No. 6193695
describes a syringe having a sealed portion between the plunger
and end cap. As the plunger is pulled away from the needle to fill
the syringe, a one-way valve in the sealed portion opens, allowing
air to be expelled from the sealed portion. During injection, the
plunger is moved toward the needle to expel its contents, the valve
closes, and the pressure in the sealed portion decreases. At the
end of its stroke, the plunger captures the needle, and the relatively
low pressure in the sealed portion causes the plunger and needle
to retract into the syringe body. Other patents of interest include
U.S. Pat. Nos. 4425120; 4643200; 4675005; 4692156; 4747830;
4816022; and 4790822.
[0005] Although the prior art has addressed many of the safety
problems related to conventional hypodermic syringes, numerous shortcomings
remain relating to the cost of manufacturing and the safe use of
syringes with retractable needles (safety syringes). Some safety
syringes require storage of potential energy, which may be unreliable.
For example, sealed vacuum chambers are prone to leakage when the
syringe is stored for an extended period. Other safety syringes
may have needles which retract a limited distance, with the retracted
needle remaining dangerously close to the syringe body opening.
Some syringes are shipped and stored with plungers fully extended,
increasing their packaged size with a corresponding decrease in
the efficiency of shipping and storage. Syringes which utilize springs
are costly, and require additional seals to prevent contamination
of the fluid drawn into the body of the syringe. Further shortcomings
exist in the prior art with regard to manufacturing cost, ease of
use, and reliability of safety syringes. A reliable syringe which
automatically retracts the needle into the syringe body is sought
which overcomes the disadvantages of the prior art.
[0006] The present invention surpasses the prior art, offering
an improved safety syringe that is both reliable and economical.
The retractable-needle or safety syringe of the present invention
is relatively simple and convenient to operate.
SUMMARY OF THE INVENTION
[0007] The present invention is directed to a safety syringe that
retracts its needle into a syringe body to prevent the healthcare
practitioner from accidentally getting stuck by the exposed needle.
The retractable needle protects various people, including healthcare
workers and their patients, and sanitation workers involved with
disposal of medical waste. The invention may prevent or reduce injuries
ranging from minor skin lacerations to serious contamination by
medications, germs, or viruses. The syringe preferably is a disposable,
single-use device, and may be available in various sizes and shapes.
A syringe according to this invention may also be used in non-medical
applications, such as chemical handling processes.
[0008] It is an object of the present invention to provide an improved
vacuum operated, retractable-needle (safety) syringe. A preferred
embodiment includes a selectively retractable needle assembly comprising
a needle seat for supporting a needle, and a generally tubular body
that serves as a reservoir both for injectable or withdrawn fluids
and for a vacuum chamber. A stopper may be selectively engaged by
a plunger and seals against the inside of the tubular body to facilitate
withdrawing fluids and creating the vacuum. The plunger is axially
moved both to draw fluid into the syringe, expel fluid from the
syringe into the patient, and create the vacuum within the tubular
body. A two-way valve regulates the flow of fluid and air flowing
into and out of the tubular body during use. A ridge or other connector
on the plunger may selectively engage the stopper so that the stopper
and plunger therefrom move as an assembly. A latch on the plunger
or the stopper selectively engages the needle seat to withdraw the
needle into the generally tubular body due to created vacuum.
[0009] The syringe may be distributed and stored in a relatively
compact packaged configuration, with the plunger substantially retracted
into the tubular body. A seal between the plunger and tubular body
(plunger seal) allows the plunger to be moved axially within the
generally tubular body while preventing air from passing into or
out of the body through the rear end of the plunger.
[0010] To use the syringe, the healthcare practitioner may first
move the plunger toward the plunger end to capture the stopper.
With the stopper captured, the plunger and stopper may now move
as an assembly within the tubular body. The practitioner then forces
the plunger axially toward the needle end, which increases the volume
of the sealed portion of the tubular body between the stopper and
plunger seal. Because air cannot enter, pressure decreases and a
vacuum is created in the sealed portion between the stopper and
the rear seal. Since the opposing side of the plunger is at atmospheric
pressure, an axial force due to the difference in the fluid pressure
is directed toward the plunger end of the tubular body, with a substantially
equal and opposite force exerted by the practitioner on the plunger.
The tubular body may have a reverse graduation which the practitioner
may use as a reference to axially move the plunger a distance corresponding
to the volume of fluid to be withdrawn from the vial.
[0011] To fill the tubular body, the practitioner may first insert
the needle into a vial or other fluid source and move the plunger
axially toward the needle end of the tubular body as described above,
thereby pressurizing the vial. The practitioner may then move the
plunger axially toward the plunger end, assisted by the vacuum,
to draw fluid into the tubular body. The practitioner may then aspirate
the syringe in a conventional manner, eliminating air and any excess
liquid. To inject the patient, the practitioner inserts the needle
under the skin and forces the plunger toward the needle end of the
body to expel the fluid, thereby again creating a vacuum in the
sealed portion of the tubular body. At the end of the plunger injection
stroke, a latch on the plunger or on the stopper engages the needle
seat, so that the plunger, stopper, and retractable needle assembly
now move as an assembly with respect to the tubular body. The practitioner
may then release the plunger, and the vacuum in the sealed portion
of the tubular body automatically moves the plunger toward the plunger
end, retracting the needle safely within the syringe body.
[0012] It is an object of this invention to provide an improved
safety syringe. The safety syringe may operate more reliably and
consistently than other safety syringes. Because the vacuum which
assists plunger movement is created during use, there is no need
for a potential energy source which may degrade or fail prior to
use. A related object of the invention is to provide an improved
safety syringe which uses a vacuum within the generally tubular
body of the syringe created by movement of the plunger to withdraw
the needle seat and the attached needle into the generally tubular
body.
[0013] Another object of the invention is to provide an improved
method of using a syringe of the type with a needle seat sealingly
engaged within the tubular body for supporting a needle, with the
needle seat being releasably retained on the tubular body in an
initial position. Movement of the plunger and an axially connected
stopper creates a vacuum between a rear plunger seal and the stopper.
A practitioner may apply a first axial force to move the plunger
to a displaced position, then insert the needle into the liquid
source and withdraw a selected volume of liquid into the tubular
body. After aspirating the air, the needle is inserted into a fluid
repository, such as a patient, and a second axial force on the plunger
is used to discharge liquid from the needle and simultaneously create
a vacuum within the tubular body. At the end of the injection stroke,
a seat/plunger latch connects the needle seat with the plunger,
or optionally with the stopper. By relaxing the second force, the
needle seat is disengaged from the tubular body and the plunger
and connected needle seat and needle are moved to the retracted
position within the tubular body.
[0014] A feature of the invention is a syringe which uses a two-way
valve between the needle seat and the generally tubular body to
control the flow of air and liquid into and out of the body. During
use, this two-way normally closed valve also may partially regulate
the force required to move the plunger.
[0015] Another feature of the invention is the use of a stopper/plunger
latch for selectively axially connecting the stopper to the plunger
by axial movement of the plunger with respect to the tubular body.
This feature allows the syringe to have a compact size for shipment
and storage. The stopper/plunger latch may include circumferentially
spaced protrusions extending radially outward from a cylindrical
surface of the plunger.
[0016] Another feature of the invention is that a "reverse"
graduation may be provided on the tubular body increasing from the
plunger end toward the needle end. The reverse graduations are used
by the practitioner to move the plunger to a selected position for
withdrawing the desired quantity of liquid into the syringe.
[0017] A significant advantage of the present invention is that
the syringe may be manufactured at a relatively low cost, and accordingly
the syringe preferably is a disposable single-use device.
[0018] Another significant advantage of the present invention is
that the safety syringe may be easily and safely operated by the
practitioner.
[0019] These and further objects, features, and advantages of the
present invention will become apparent from the following detailed
description, wherein reference is made to the figures in the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] FIG. 1 illustrates in cross-section an embodiment of the
safety syringe according to the present invention in an initial,
packaged configuration.
[0021] FIG. 2 is an enlarged cross-sectional view of a portion
of the syringe shown in FIG. 1.
[0022] FIG. 3 shows the plunger in a fully retracted position engaged
with the stopper.
[0023] FIG. 4 illustrates in greater detail the plunger end of
the cylinder body opposite the needle end, the stopper and the rear
plunger seal.
[0024] FIG. 5 shows the syringe with the needle tip in a vial.
[0025] FIG. 6 shows in greater detail the needle end of the syringe
and the retractable needle seat.
[0026] FIG. 7 shows the syringe after the plunger has been moved
from an initial position to a selected, displaced position.
[0027] FIG. 8 shows the sealed vacuum portion between the stopper
engaged with the plunger and the rear plunger seal.
[0028] FIG. 9 shows in greater detail the two-way valve in the
needle end of the tubular body.
[0029] FIG. 10 shows the syringe with its needle in a fully retracted
position after use.
[0030] FIG. 11 is a pictorial view of the generally tubular body.
[0031] FIG. 12 is a pictorial view of the plunger.
[0032] FIG. 13 is a pictorial view of the needle seat.
[0033] FIG. 14 is a pictorial view of the two-way valve.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0034] FIG. 1 shows a syringe 10 in an initial packaged configuration
for shipment and storage, with greater detail shown in FIG. 2. A
generally tubular body 14 which may house medicine or other liquid
during use of the syringe 10 has a needle end 18 an opposing plunger
end 22 a cylindrical throughbore 26 and a central axis 27. The
tubular body 14 is preferably plastic, but may comprise other nonporous
or leak proof materials.
[0035] As shown in FIG. 2 a needle seat 30 is received within
the throughbore 26 and at least partially within the reduced diameter
portion 29 at the needle end 18 of the tubular body 14. Prior to
use, the needle seat 30 is axially and sealingly attached to the
tubular body 14 held in an initial retained position by a seta/body
retainer 33 on the tubular body 14 which may be a generally annular
bead. The radially outer portion 34 of the needle seat 30 is captured
between the bead 33 and body stop 15 thereby securing the needle
seat to the body 14. The radially outer portion 34 may comprise
a plurality of circumferentially spaced tabs, as shown in FIG. 13.
The radially outer surface 35 of each tab 34 is preferably tapered.
The needle seat 30 is configured for release from the body 14 as
discussed below.
[0036] The needle seat 30 supports a needle 38 (see FIG. 3) which
may pierce a layer of skin to transport medicine or other fluid
subdermally. The needle seat end portion 31 as shown in FIG. 2 may
be configured for attachment to a conventional needle/hub by a quarter-turn
"spiral-lock" conventionally used with syringes, and the
thread for that lock is shown more clearly in FIG. 13. The needle
seat 30 is selectively moveable from the initial retained position
to a needle retracted position (see FIG. 10), at which the attached
needle 38 is substantially internal to the tubular body 14. The
needle seat 30 includes a seat/plunger latch 32 (see FIGS. 6 and
13) opposite the end which receives the needle 38.
[0037] Referring again to FIG. 2 a plunger 42 may be used to expel
the contents of the syringe 10 toward the needle end 18 and out
through the needle 38. The plunger 42 has a needle seat end 46 positioned
within the tubular body 14 and an opposed push plate end 50 extending
from the tubular body 14 the plunger 42 being axially moveable
relative to the tubular body 14. A rear plunger seal 44 is provided
for sealing between the plunger 42 and the plunger end 22 of the
tubular body 14. The plunger has a push plate 51 on the end 50
and the body 14 includes radially opposing finger tabs 53 as shown
in FIGS. 2 and 11. The plunger 42 as shown in FIG. 2 has both a
seat/plunger latch 54 and a plunger/stopper latch 58 near the needle
seat end 46. As disclosed subsequently, the seat/plunger latch 54
on the plunger may selectively engage the seat/plunger latch 32
on the needle seat 30 to axially secure the needle seat 30 to the
plunger 42. The plunger/stopper latch 58 may axially secure a stopper
62 to the plunger 42.
[0038] The initial packaged configuration of the syringe as shown
in FIG. 1 is relatively compact, with the plunger 42 substantially
within the tubular body 14. The needle seat end 46 is preferably
near the needle seat 30 but the seat/plunger latch 54 is not yet
engaged with the latch 32 on the needle seat 30. The stopper 62
is positioned near the plunger end 22 and is in sealed engagement
with the tubular body 14.
[0039] To initiate the filling process (see FIGS. 3 and 4), the
plunger 42 is first moved into a fully retracted position to capture
the stopper 62 via the plunger/stopper latch 58. During this process,
the circumferentially spaced latch tabs 58 as shown in FIG. 12 thus
compress the elastomeric material of stopper 62 against the bore
walls of the throughbore 26 until the tabs 58 move into the stopper
recess 63 with latch shoulder 59 on the plunger 42 engaging stop
surface 61 on the stopper 62.
[0040] The plunger 42 along with the now captured stopper 62
may then be moved from an initial position to a selected displaced
position, as shown in FIG. 7. Because the stopper 62 is sealingly
engaged with the tubular body 14 pressure decreases within the
tubular body 14 between the stopper 62 and the rear seal 44. Simultaneously,
air in the syringe throughbore passes through the needle to pressurize
the vial 66. A reverse gradation 16 as shown in FIG. 11 is preferably
included on the tubular body 14 so the selected displaced position
corresponds to a pre-determined volume of liquid that will be subsequently
withdrawn from a fluid source 66.
[0041] The needle 38 is inserted or previously was inserted into
the vial or other fluid source 66 and the plunger 42 is moved back
toward the plunger end 22 of the tubular body 14 to a fluid withdrawn
position, drawing a desired volume of fluid from the fluid source
66 into the syringe 10. The vacuum described above may assist the
process of withdrawing fluid, although the valve described below
preferably is biased closed with a sufficient force so that the
healthcare practitioner pulls the plunger and thus the stopper toward
the opposing plunger end of the body. Air may then be aspirated
from within the body 14 through the needle 38. The syringe 10 and
its contents are now ready for the injection process.
[0042] After the needle 38 has been inserted below the skin of
a patient, the plunger 42 is forced axially toward the needle end
18 and the fluid forced by the stopper 62 out through the needle
38 and into the patient. At the end of the injection stroke, the
seat/plunger latch 54 on the plunger 42 engages the seat/plunger
latch 32 on the needle seat 30 thereby capturing the needle seat
30. In this fully stroked position, a substantial vacuum exists
between the stopper 62 and the rear plunger seal 44 relative to
the pressure in the tubular body 14 on the opposing side of the
stopper 62. When the practitioner releases the axial force on the
plunger 42 the created vacuum pulls the plunger 42 back toward
the plunger end 22 disengaging the needle seat 30 from the tubular
body 14 and withdrawing the needle seat 30 and attached needle
38 into a retracted position within the tubular body 14 (see FIG.
10). The generally annular bead 33 on the body 14 functions as a
stop for the tabs 34 and thus the seat 30. The outer portion 34
initially engages this stop, but is subsequently moved radially
inward by the latch 54 which both engages the seat via latch 32
and releases the seat 30 by disengaging tabs 34 from bead 33.
[0043] In a preferred embodiment, the syringe 10 includes a two-way
valve 36 and as shown in FIGS. 6 9 and 14 for governing fluid flow
into and out of the tubular body 14. As shown in FIG. 6 the two-way
normally closed valve 36 may include a first valve member 39 which
is opened in response to relatively higher pressure internal to
the tubular body 14 between the stopper 62 and the needle seat 30.
The two-way valve 36 also includes a second valve member 37 which
is opened in response to a relatively higher pressure external to
the tubular body 14. The valve 39 may be referred to as a duck-bill
valve, and the valve 37 which seals against planar surface 35 on
the needle seat 30 may be referred to as an umbrella valve. When
closed, the two-way valve 36 seals off needle seat 30 preventing
liquid and/or air from entering or escaping the tubular body 14.
[0044] The two-way valve 36 may be formed from an elastomer so
that it may be pressed into the central passageway 33 in the seat
30 (see FIG. 13), then locked in place about the reduced neck portion
of the needle seat, with a pair of radially opposing ports as shown
in FIG. 13 providing the flow channels to open the valve 37 releasing
from a surface 65 of seat 30. The duck-bill valve 36 opens as shown
in FIG. 6 to expel air or fluid from the body 14 through the needle.
The inclusion of the two-way valve may also help control the movement
of the plunger 42. For example, the two-way valve may prevent the
plunger 42 from automatically retracting all the way to the plunger
end 22 during the filling process. This may help control the operation
of the syringe 10 for example, by preventing the plunger 42 from
suddenly and unexpectedly snapping back the entire distance to the
plunger end 22.
[0045] In a preferred embodiment, the seat/body retainer as shown
in FIG. 6 may comprise a generally circumferential bead 33 on the
body 14 and a plurality of circumferentially spaced locking tabs
34 each moveable radially inward in response to the seat/plunger
latch 54. As the seat/plunger latch 54 engages with the seat/plunger
latch 32 on the needle seat 30 the seat/plunger latch 54 also moves
the locking tabs 34 radially inward, disengaging the locking tabs
from the bead 33 on the tubular body 14 so that the needle seat
30 may freely retract into the tubular body 14 as described above.
[0046] Preferably the syringe according to the present invention
is a disposable single-use device. The stopper is preferably sealingly
secured to the plunger when the stopper/plunger latch 58 is engaged.
The stopper/plunger latch preferably includes tabs extending radially
outward of the cylindrical surface of the plunger for capturing
the stopper. As explained herein, the plunger is axially connected
to the stopper using the stopper/plunger latch, although in other
embodiments the stopper could be axially secured to the plunger
and the syringe shipped in that configuration to the practitioner.
Since the plunger would extend axially a substantial distance from
the cylinder body, the length of the syringe is undesirably increased,
creating further handling and storage problems.
[0047] The needle may be shipped separately from the syringe, and
the needle then attached to the needle seat in a conventional manner.
In other embodiments, the needle and needle seat could be formed
as a single unit, and the syringe shipped with the needle extending
from the tubular body.
[0048] A preferred plunger/seat latch according to the present
invention may include a female latch member 54 on a plunger and
a male latch member 32 on the seat. The stopper/plunger latch includes
a male member 58 on the plunger, with the body of a plunger serving
as the female member. In other embodiments, the latch member may
be provided on only one of the plunger and the seat for selectively
securing the plunger to a seat, and a latch similarly may be provided
on only one of the plunger and the stopper to selectively connect
these components.
[0049] Various types of rear plunger seals may be used for reliably
sealing between the rear portions of the tubular body and the plunger,
and the seal 44 is merely exemplary. Various types of plungers or
pistons may be used for reliably sealing the tubular body during
axial movement of the plunger. Other types of retainers may be used
for initially retaining the seat 30 in the needle end of the tubular
body, and thereafter yielding or releasing the seat once engaged
by the plunger to withdraw the needle seat and needle into the tubular
body.
[0050] The method of the present invention will be readily understood
to those skilled in the art in view of the above discussion. The
syringe when used has the needle seat sealingly engaging the generally
tubular body and retained in an initial retained position. The stopper
is provided within the throughbore of a tubular body, and a plunger
extends at least partially within the throughbore of the tubular
body. The rear plunger seal is sealingly engaged with the plunger
end of the tubular body and the plunger for effecting a vacuum chamber
inside the tubular body and between the stopper and the rear plunger
seal. A practitioner may axially interconnect the plunger and the
stopper, then apply a selective first axial force to move the stopper
from an initial position toward the opposing plunger end of the
tubular body to a displaced position, thereby creating a partial
vacuum within the tubular body. A needle is then inserted into the
liquid source, but preferably is inserted prior to applying the
first axial force to pressurize the liquid source (typically a vial)
with air. A selected volume of liquid from the liquid source is
then withdrawn into the tubular body between the needle seat and
the stopper while simultaneously moving the stopper from a selected
displaced position to a fluid drawn position. The biasing force
on the closed valve 36 typically is greater than the vacuum force,
so that the practitioner normally pulls the plunger back to draw
fluid into the syringe. After moving the needle from the liquid
source and aspirating the air from the syringe, the needle may be
inserted into a fluid repository, such as the patient. Thereafter,
a second axial force is applied by the practitioner to the plunger
to move the stopper toward the needle end of the tubular body to
discharge liquid from the tubular body and simultaneously create
a partial vacuum within the tubular body between the stopper and
the rear plunger seal. At the end of the injection stroke, the seat/plunger
latch is engaged to connect the needle seat with one of the plunger
and the stopper. The second force is then relaxed to disengage the
needle seat from the tubular body and move the plunger and connected
needle seat from the initial retained position to the needle seat
retracted position.
[0051] In a preferred embodiment, the seat/plunger latch connects
the needle seat with the plunger. In an alternate embodiment, the
plunger may be provided with a latch mechanism for engaging the
needle seat, in which case the seat may be connected to the plunger
through the stopper.
[0052] The two-way normally closed valve is provided for withdrawing
fluid into the tubular body and subsequently expelling the fluid
from the tubular body. The syringe preferably includes graduations
on the tubular body which increase from the plunger end toward the
needle end. These graduations allow the practitioner to withdraw
a selected quantity of liquid into the syringe.
[0053] A particular feature of the present invention is that the
syringe is of relatively low cost, and the needle is reliably drawn
into the tubular body after use. The syringe according to the present
invention is particularly well suited for use when injecting a small
quantity of fluid, e.g., less than 5 cc, and in some applications
the tubular body may hold less than a maximum of about 3 cc.
[0054] In addition to medical applications, the syringe may be
used in other non-medical applications. For example, if using the
syringe for chemical extraction and disposal, rather than injection
into a patient, the syringe 10 may be used to inject fluid into
a different type of fluid receptacle, such as an open flask or other
chemical handling media. The needle 38 may be designed accordingly
to accommodate the desired process. For example, whereas a human
patient may require use of a narrow, sharp needle, chemical extraction
and disposal may require a larger needle to extract larger volumes
of chemical fluids, or fluids with a higher viscosity.
[0055] It may be appreciated that changes to the details of the
illustrated embodiments and systems disclosed are possible without
departing from the spirit of the invention. While preferred and
alternative embodiments of the present invention have been described
in detail, it is apparent that further modifications and adaptations
of the preferred and alternative embodiments may occur to those
skilled in the art. However, it is to be expressly understood that
such modifications and adaptations are within the spirit and scope
of the present invention, as set forth in the following claims. |