Safety syringe abstract
The present invention is a safety syringe for use with a plurality
of interchangeable needles. The plurality of needles may be inserted
by the user into the safety syringe for use. In operations, the
user selects the desired needle, e.g., a needle having a particular
gauge or size or of a particular type. The user inserts the needle
into a safety syringe comprising a barrel, a needle assembly area
located within or attached to the barrel and a plunger. The needle
couples to the syringe by a number of means. For instance, a locking
mechanism may be used by which a needle hub located within the needle
assembly has an area adapted to mate with a corresponding area on
the needle. Or, the needle may be formed as part of a separate needle
assembly, whereby the user will place the entire needle assembly
onto the end of the syringe barrel. During use, the user operates
the syringe, using one hand to depress the plunger, which ultimately
causes a spring to propel the needle into the barrel of the syringe.
Safety syringe claims
What is claimed is:
1. A safety syringe comprising: a) an interchangeable needle; b)
an elongated barrel having first and second ends, the interchangeable
needle attached to a threaded first end of a needle hub; c) a plunger
sized and shaped to be received in the second end of the barrel
and to be moveable therein; d) a moveable base adapted to releasably
constrain a needle hub, said moveable base adapted for slideable
movement of said base and said needle hub within an interior of
said elongated barrel and in the direction of said first end of
said barrel; e) a spring, at least partially compressed, said spring
positioned entirely within the barrel and surrounding a portion
of said needle hub between a base of said needle hub and said threaded
first end of said needle hub, said spring adapted to bias the interchangeable
needle within the barrel; and f) at least one support member having
a first end and a second end, said support member positioned within
said barrel, said first end of said support member engaging said
base and a second end engaging an edge of a needle assembly, said
needle assembly edge positioned along an interior wall of said barrel,
said at least one support member further surrounding an axial portion
of each of said needle hub and said partially compressed spring;
wherein the plunger is moved within the barrel applying force to
the interchangeable needle and causing the spring to retract the
needle hub and associated interchangeable needle within the plunger.
2. The syringe of claim 1 further comprising catches having flexible
supports on the moveable base.
3. The syringe of claim 2 further comprising an integral sacrificial
seal on the moveable base.
4. The safety syringe of claim 3 in which the needle further comprises
an interchangeable needle head, which is adapted for mating insertion
with a needle hub associated with the first end of the barrel.
5. The safety syringe of claim 4 in which the interchangeable needle
head has a portion with threads thereon adapted for mating with
threads of the needle hub and for screwing the interchangeable needle
head to the barrel and wherein the plunger has a rupturable web
on one end through which the needle hub is forced when the spring
triggers.
6. The syringe of claim 5 further comprising a circular groove
on the needle hub for guiding the needle head into the syringe.
7. The syringe of claim 5 wherein the needle head is formed to
lock behind a needle catch in the plunger.
8. The syringe of claim 5 further comprising a needle guard releasably
affixing the needle and needle head therein.
9. The syringe of claim 1 further comprising a block defined by
said needle hub, said block engaging an edge of a passageway defined
by said needle assembly.
10. The syringe of claim 1 further comprising a plurality of fins
defined along an exterior of a needle head, said fins adapted for
mating with a corresponding slot defined by an interior of a needle
guard.
11. A method for operating a safety syringe with an interchangeable
needle selected from a plurality of needles having differing characteristics,
the method comprising: a) selecting a first threaded needle from
the plurality of threaded needles; b) associating the first threaded
needle with a syringe comprising a needle assembly, a threaded barrel
and a plunger; c) injecting a fluid from the syringe; d) moving
a plunger having a seal through the elongated barrel into contact
with a movable base in the elongated barrel, said moveable base
containing a hub of said first needle and in communication with
a spring positioned on said hub between a base of said hub and a
threaded portion of said needle hub, said needle hub and said spring
moveable as said base moves; e) forcing the base containing said
hub of said needle, a support engaging said base and surrounding
an axial portion of said hub and further surrounding said spring
partially supported on said hub, in the direction of the needle
assembly such that said spring is triggered, thereby projecting
the needle into a hollow of the plunger.
12. The method of claim 11 further comprising capturing the needle
hub and the needle within the hollow of the plunger and locking
the needle hub and plunger within the barrel.
13. The method of claim 12 further comprising guiding the needle
head into the syringe by using a circular groove on the needle assembly.
14. The method of claim 13 further comprising the steps of: a)
applying force to a thumb push of the syringe transmitting a force
along the plunger to the base, which is deformable and coupled to
supports; b) continuing the application of force until the supports
flex and close forcing a flange to move along a wall of a needle
assembly allowing forward movement of the deformable base and the
needle therein and compression of an energy storage means; c) deforming
the deformable base causing the flange to lose contact with the
deformable base, which thereby releases energy stored within the
energy storage means to project the interchangeable needle into
a hollow of the plunger; d) locking the interchangeable needle in
the plunger via a measuring means; e) revealing a biohazard label
viewable through the barrel; and f) locking the plunger within the
barrel to form a liquid tight seal between the plunger and the barrel.
Safety syringe description
FIELD OF THE INVENTION
This invention relates generally to the art of safety syringes
and more particularly to a safety syringe with an interchangeable
needle which reduces the likelihood of unintentional puncture or
pricking of human skin.
BACKGROUND OF THE INVENTION
In recent history, the transmission of contagious diseases, particularly
those brought about exclusively by the co-mingling of human body
fluids, has been of great technological interest. One of the particular
problems has been associated with the use and disposal of hypodermic
syringes, particularly among healthcare professionals. There have
been various devices developed for the destruction of the needles
or cannula used in such syringes. Additional devices have been developed
for capping of syringes, while fixed needle safety syringes have
also been designed, all of which attempt to minimize the likelihood
of accidental puncture. The accidental puncture or pricking of a
finger, or any other part of the body, after the treatment of a
patient with a contagious disease, particularly a deadly contagious
disease, results in a high likelihood of transmission of that disease.
Various syringes have been developed in the prior art to attempt
to minimize the likelihood of accidental puncture after patient
treatment.
One such device is described in U.S. Pat. No. 4973316 to Dysarz
wherein a needle is retracted into the barrel of the syringe after
the use thereof. Another such device is described in U.S. Pat. No.
4921486 to DeChellis, et al.
Other references describing devices relating to needle retraction
in a syringe include U.S. Pat. No. 4994034 to Bostich et al.,
U.S. Pat. No. 4838869 to Allard, and U.S. Pat. No. 5114410 to
Batlle, GB 2 197 792 to Powers et al., WIPO 90/06146 to Nacci et
al., and WIPO 90/03196 to Utterberg et al. Additionally, U.S. Pat.
No. 5407431 to Bostich, et al, describes a safety syringe with
an interchangeable needle. While all such devices seek the same
goals of preventing accidental puncture and providing user flexibility,
considerable room for improvement exists.
SUMMARY OF THE INVENTION
These as well as other objects are accomplished by a hypodermic
syringe having a barrel with a plunger movable therein to inject
a fluid through a hollow needle thereof. A hollow needle hub is
housed in a passageway within a needle assembly to which is releasably
attached a replaceable needle. Positioned between the passageway
within the needle assembly and a shelf on an internal wall of the
syringe barrel is a deformable base, with integral flexible supports.
The deformable base forms a liquid tight seal with the barrel, at
the needle end of the barrel. The deformable base houses a head
of the needle hub, forms a liquid tight seal with the base, and
is in contact with energy storage means within the passageway in
the needle assembly. The plunger has a thin, rupturable web on an
end thereof which is part of a boot covering the end of the plunger,
the boot, including the web, being liquid impermeable for forcing
a liquid from the barrel upon movement of the plunger. Upon completion
of an injection, the boot covered plunger contacts the deformable
base, and upon application of force at the plunger, moves such base
downward. Continued application of force causes flexible supports
to flex and move over the sidewall of the needle assembly, permitting
the deformable base to move the head of the needle hub downward
until further movement of the needle hub is blocked by the passageway
in the needle assembly. With the needle hub blocked by the passageway,
continued force at the plunger causes the deformable base to move
around the needle hub. As the deformable base moves further, the
needle hub begins to protrude from the deformable base and come
into contact with a web on the boot of the plunger.
Continued force causes the head of the needle hub to tear the web
of the boot, positioning the needle hub just inside a hollow portion
of the plunger. The torn portion of the web creates a flap just
inside the hollow plunger. As the plunger moves the deformable base
still further, the needle hub eventually looses contact with the
deformable base, which triggers a release of energy from the energy
storage means in the passageway, projecting the needle hub with
its changeable needle attached thereto into the hollow portion of
the plunger. Once inside the plunger, the needle hub is trapped
by its enlarged head behind a flexible catch within the plunger.
Final movement of the plunger causes the plunger to become substantially
locked in the barrel and causes a liquid tight seal to be created
between the plunger and the syringe body. A closing member placed
on the front of the needle assembly completely seals the syringe
to prevent residual fluids from escaping. Completion of the needle
retraction also automatically highlights an indicia such as a biohazard
label which alerts persons handling the device that the syringe
has been used and represents a potential biohazard.
In multiple alternative embodiments presented later, various methods
are taught to effect changeability of the needle. For these embodiments
concepts of operation of the retractable needle may be substantially
the same, or other means of causing the needle to retract may be
used. Rather than focusing on the retraction method, these embodiments
focus on various ways of allowing needles of varying gauges to be
used with same basic syringe body. One embodiment generally accomplishes
this by forming a head on the needle that can mate with, in a detachable
fashion, a needle hub that is formed as part of the syringe body,
simply attached to the syringe body or otherwise associated with
the syringe body. By way of example, the needle head may be formed
with threads for mating with corresponding threads inside the needle
hub. Or, snap-lock ridges may be inscribed on the needle head and
needle hub so that the two can mate in a locking fashion. Many different
mating connections can be used, so long as the needle head can be
detachably inserted into the needle hub without causing the spring
or other propellant means to trigger during the installation process.
In other words, one cannot require substantial force for detachably
inserting and removing the different sizes and types of needles
because otherwise the act of interchanging needles will cause the
syringe to trigger, this rendering it useless.
Other methods may be used for forming an interchangeable needle
while accomplishing this objective. For instance, in stead of simply
inserting the head into a mating needle hub, the needle hub itself
could be detachably connected to the syringe body. This would allow
the user simply to unscrew one complete needle hub assembly and
replace it with another. One advantage to this approach is that
the needle hub could be formed so as completely to contain the mechanism
for restraining the needle against the bias of the spring or other
propelling means. Another advantage is that the assembled needle
hub and needles may be larger and thus easier for the user to deal
with than simply just another gauge needle. Additionally, because
the needle hub can be formed with a ledge or the like to support
a needle guard that will surround the needle before use and prevent
sharps injuries, one can leave a guard on the needle hub while installing
the entire assembly onto the rest of the syringe body.
This invention accordingly aims to provide a hypodermic safety
syringe having one, more or combinations of the following advantages:
the ability to minimize the likelihood of accidental puncture. the
ability to use an interchangeable needle, before syringe utilization,
for selection of the optimum needle type and gauge for patient procedures
and effectiveness and to provide a syringe which also provides automatic
indication that the syringe represents a biohazard after utilization.
the ability to, after utilization with a patient, captures and isolates
the used needle so as to render such needle harmless. the ability
to a hypodermic syringe which is operable utilizing only one hand.
to provide such a syringe which automatically, upon the end of an
injection, retracts the interchanged needle to prevent its reuse,
while sealing the needle within the body of the syringe to prevent
leakage of residual fluids. to provide a simple device, which is
manufacturable in high volumes.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a cross-sectional view illustrating a completed assembly
of the needle hub, base, barrel, needle assembly, and energy storage
means of a syringe of this invention.
FIG. 2 is a sectional view of a replaceable needle head and needle
of this invention.
FIG. 2A is an enlarged view of the encircled area in FIG. 2.
FIG. 3 is a sectional view of a replaceable needle head and a filter
needle of this invention.
FIG. 4 is a sectional view of an alternative embodiment of a replaceable
needle head and needle of this invention.
FIG. 5 is an isolated sectional view of the barrel of this invention.
FIG. 5A is a cross-sectional view along line 5A--5A of FIG. 5.
FIG. 6 is a side view of the needle hub.
FIGS. 6A, 6B, and 6C are enlarged partial side views of the end
of the needle hub of this invention illustrating alternate embodiments
of sealing mechanisms.
FIG. 7 of the drawings is an elevational side view of the energy
storage means.
FIG. 8 is a cross-sectional subassembly view illustrating the assembly
of the needle hub and base.
FIG. 9 is a cross-sectional subassembly view illustrating the assembly
of the needle hub, base, and barrel.
FIG. 10 is isolated sectional view of the needle assembly of this
invention.
FIG. 10A is an isolated sectional view of the guard edge of the
needle guard.
FIG. 11 is an isolated sectional view of a plunger in accordance
with this invention.
FIG. 12 is a cross-sectional view of the plunger of this invention,
showing assembly of the plunger boot and the plunger seal on the
plunger.
FIG. 13 is a cross-sectional view of the syringe of this invention
in an operable pre-activation state.
FIG. 14 is an elevational view of the needle guard, showing the
needle assembly closing member tethered, for example, to the tip
of the needle guard.
FIG. 14A is an enlarged view of the encircled area of FIG. 14.
FIG. 15 is a cross sectional view of the completed assembly of
the syringe, including the needle guard.
FIGS. 16 17 18 19 20 21 22 23 24 and 24A are cross-sectional
views of the syringe of this invention showing the sequence of operation,
after the injection cycle.
FIG. 25 is a graph depicting the Force/Balance relationship upon
which the syringe operation is based.
FIGS. 26 26A, 27 27A, 28 28A, 29 30 31 and 32 are sectional
views of an alternative embodiment of the interchangeable needle
head and needle and subassembly of the needle hub, base, barrel,
needle assembly, and energy storage means of a syringe of this invention,
where no supports are utilized in the subassembly and the needle
hub is blocked in the passageway.
FIGS. 33 33A, 34 34A, 35 35A, 36 37 38 and 39 are sectional
views of another alternative embodiment of the interchangeable needle
head and needle and subassembly of the needle hub, base, barrel,
needle subassembly, and energy storage means of a syringe of this
invention, where no base supports are utilized in the subassembly,
a shelf on the needle assembly contacts the end of the barrel, a
taper on the base mates with a taper in the body, and is blocked
in the needle hub in the needle assembly.
FIGS. 40 40A, 41 42 42A, 43 44 45 46 47 47A, and 48 are
sectional views of an alternative embodiment showing a replaceable
nose and needle assembly cooperating with an assembly of the needle
hub, base, barrel, needle assembly, and energy storage means of
a syringe of this invention.
FIGS. 49 49A, 50 51 51A, 52 53 54 55 55A, 56 and 56A are
sectional views of an alternative embodiment of a replaceable nose
and needle assembly and subassembly of the needle hub, base, barrel,
needle assembly, and energy storage means of a syringe of this invention.
FIG. 57 is an elevational view of the syringe prior to needle retraction.
FIG. 58 is an elevational view of the syringe subsequent to needle
retraction wherein an indicia has been revealed.
DETAILED DESCRIPTION OF THE INVENTION
Before describing the drawings and embodiments in more detail,
several terms are described below in an effort to clarify the terminology
used in this document. Additional and fuller understanding of these
terms will be clear to persons skilled in this art upon reading
this entire document: "Needle assembly": refers to the
area on the end of the syringe in which the needle, spring or base
are assembled. The needle assembly can be a separate, physical piece
that is attached to or associated with the rest of the syringe body.
Alternatively, the needle assembly could be just the section of
the syringe body near which the needle, spring, or base are partially
or completely located. "Needle head": refers to the end
of the needle that is associated with the syringe and which has
an enlarged area. The enlarged area may be formed as part of the
needle itself, or may be an additional piece fitted to the needle
end. The enlarged area may be formed of plastics, metal or other
suitable materials. "Needle hub": refers to a device that
mates with the needle head. The device may be a separate, generally
elongated device placed in the needle assembly area between, e.g.,
a base an one end of the needle assembly. Alternatively, the needle
hub may be formed as part of the base, needle assembly or other
component located in that area. "Attached to": means that
physical parts are actually attached, possibly with an intermediate
member between them, either by welding, gluing, snap-lock fit, screws
or other attachment mechanisms known in the art. The attachment
is designed to be semi-permanent in that the user does not normally
remove the physical parts that are said to be attached. "Associated
with": means that the devices in question are permanently or
detachably coupled. Associated with is intended to be broader in
scope than "attached to," and covers devices that users
may or may not be able to remove.
In accordance with this invention it has been found that a syringe
may be provided for normal operation which permits changing a needle
subsequent to use, but which, upon completion of normal operation
and continued movement of a plunger, results in a triggering of
a needle hub with the interchangeable needle to project such needle
harmlessly into the plunger and body of the syringe.
Once trapped inside the plunger and body of the syringe, the needle
is no longer subject to accidental pricking or poking of human tissue
thus minimizing the likelihood of transfer of a contagious disease
which may be carried by fluids contained on the surface of or within
such needle. To prevent possible leakage of residual fluids in the
needle, the syringe is scaled after use, and after such use an automatic
indication is given that the syringe represents a biohazard. Various
other advantages and features will become apparent from a reading
of the following description given with reference to the various
figures of drawing.
FIG. 1 is a cross-sectional view illustrating a subassembly of
a needle hub 2 base 4 barrel 6 needle assembly 8 and an energy
storage means 10 of a syringe 1 (shown in FIG. 13) of this invention
in a normal pre-injection position. In a preferred embodiment, energy
storage means is a spring 10. Base 4 is shown as a deformable body,
but could be formed of multiple pieces, e.g. one piece that is deformable
(such as an o-ring or the like) and others rigid. Needle assembly
8 is affixed to the barrel 6 by guiding the threaded end of needle
hub 2 through the center of passageway 15 and inserting needle assembly
8 into the front of barrel 6 until mating shelf 17 on needle assembly
8 contacts and is positioned against the top edge of the barrel
6. Permanent joining between the needle assembly 8 and the barrel
6 can be accomplished by ultrasonic welding around the circumference
of barrel 6 at overlap 7 between the two parts, or any other permanent
attaching means can be used. Attachment of the needle assembly 8
to the barrel 6 creates a liquid tight seal between the two parts.
As a result of this assembly step, a terminal edge of the needle
assembly 8 is positioned just in contact with engaging flanges 19
of at least one supports member 21 having a first end and a second
end thus preventing movement of the base 4 and the needle hub 2
contained therein for normal syringe use. If the needle hub 2 is
formed as part of a single molded syringe barrel 6 then the needle
head 2 could be molded with a ridge or the like against which flanges
19 could bear. A preferred material for the base 4 is an elastomer.
Support member 21 is illustrated in the preferred embodiment as
a pair of opposing semicurcular cantilevered beams, however, it
is envisioned according to this invention that supports member 21
could be connected and unitary, divided up further, or in some embodiments,
be eliminated all together.
FIG. 2 shows a sectional view of a replaceable needle head 12 and
needle 14 of this invention. Fixed and sealed into a cavity 13 of
the needle head 12 is the needle 14 by means of adhesive 16 or
other means of fixing needle hub 2 to needle head 12. Female threads
18 are illustrated for releasably attaching, or detaching, the needle
head 12 to the needle hub 2 fixed within the passageway 15 of the
needle assembly 8. A bevel 20 of the needle head 12 mates with a
bevel 22 in the needle hub 2 to create a liquid tight seal between
the two parts. Alternate embodiments of sealing mechanisms are illustrated
in FIGS. 6A, 6B, and 6C. Fins 23 on needle head 12 (as shown in
FIG. 2) mate with slots 25 in a needle guard 27 as seen in figure
14 which releasably fix the needle guard 27 to the needle head
12 and prevent rotation of needle head 12 in the needle guard 27.
This invention provides for releasably attaching a variety of types
and styles of needles to the needle hub 2 within the passageway
15 because the configuration of the needle hub 2 and needle head
12 remain constant and allow mating of needles 14 of various lengths
and features to the syringe 1. For example, needles 14 ranging from
a 18 gauge to a 26 gauge of various lengths may be used with this
invention. Additionally, filter needles which are not intended to
be retractable work with this invention as prescribed in standard
syringe practice. Moreover, the interchangeable needle safety syringes
of this invention may be compatible with syringes of other manufacturers
including those made by Retractable Technologies and New Medical
Technologies, Inc.
FIG. 2A is an enlarged view of the encircled area of FIG. 2 showing
fins 23 and recess 29 on fin 23 used for releasably fixing the needle
guard to the needle head 12.
FIG. 3 shows a sectional view of a replaceable needle head 26 and
a filter needle 24. Adhesive 28 or other satisfactory means binds
the needle 24 to the needle head 26. A filter 30 is positioned between
the needle 24 and the needle head 26 to protect from any debris
entering the barrel during the syringe fill cycle. The uncontaminated
filter needle is not retracted into the syringe but is removed and
thrown away after use and replaced by another replaceable needle
which is generally retractable.
FIG. 4 is an alternative embodiment of a needle 14 disposed within
the needle head 12. The needle head 12 is the same as the needle
head 12 shown in FIG. 2. FIG. 4 shows an example of a different
length and gauge needle 14 where the needle shaft is shorter than
the needle shaft shown in FIG. 2.
FIG. 5 shows an isolated section view of the barrel 6. FIG. 5A
is a cross-sectional view along line 5A--5A of FIG. 5 showing a
finger support flange 40 of the barrel 6 of this invention. Referring
to FIGS. 5 and 5A, an undercut 42 for locking the plunger into the
barrel is shown at the finger support flange 40 of barrel 6. At
the opposite end of the barrel 6 a base shelf 3 and a base relief
shelf 44 are illustrated. These internal offsets receive the base
in the case of shelf 3 while the function of the shelf 44 is to
provide room for base expansion as the base 4 is deformed and travels
over hub 2 during operation.
FIG. 6 shows an isolated view of the needle hub 2. Top 46 flange
48 spring contactor 50 hub catch receiver 52 and hub block 54
are illustrated. Needle hub 2 male threads 56 and bevel 22 are also
illustrated and are used to releasably attach the needle head 12
to needle hub 2 while also creating a liquid tight seal between
the two parts.
FIGS. 6A, 6B, and 6C illustrate alternate embodiments for sealing
mechanisms of needle hub 2 to the needle head. FIGS. 6A and 6B represent
seals 51 and 53 formed as integral and unitary parts of the needle
hub 2 while FIG. 6C illustrates seal 55 as an O-ring seal.
FIG. 7 is an elevational view of the energy storage means 21 illustrated
as a spring 10.
FIG. 8 shows an assembly step accomplished by inserting the needle
hub 2 into the base 4. Once inserted, a base wedge 58 is positioned
for a substantially mating engagement over a flange 48 of the needle
hub 2 which blocks needle hub 2 movement in both directions when
inserted in the barrel 6. A liquid tight seal between the needle
hub 2 and a needle hub seal 60 on the base 4 as shown in FIG. 8
is created at the needle hub 2. With the needle hub 2 blocked into
the base 4 the next assembly step is accomplished.
FIG. 9 shows the next step of the assembly process, where the subassembly
in FIG. 8 is inserted into the front end of the barrel 6 as shown
in FIG. 9 until the base 4 contacts and is positioned against the
base shelf 3. When the base 4 is completely inserted as shown in
FIG. 9 the base 4 is compressed circumferentially in the direction
of the needle hub 2 and a liquid tight seal is produced between
the base 4 and the barrel 6 and needle hub 2 is restrained from
movement.
FIG. 10 shows an isolated sectional view of the needle assembly
8 of this invention. The passageway 15 is shown and is defined within
the needle assembly 8. A circular grove 64 on the needle assembly
8 serves as a guide for positioning the needle head 12. A rotating
shelf 17 contacts and is positioned against the edge of the barrel
6. In an alternative embodiment, the needle assembly 8 is transparent
providing for viewing a joint between the needle hub 2 and the needle
head 12 after the needle 14 is changed.
FIG. 10A shows the circular groove 64 on the needle assembly 8
that serves as an indicator that needle head 12 is in proper position
when a guard edge 65 on the guard 27 (shown in FIG. 14) is over
the center of the groove 64.
FIG. 11 of the drawings is an isolated sectional view of a plunger
66 in accordance with this invention. A capturing means 68 is illustrated
for capturing the needle hub 2 with interchangeable needle 14 attached
thereto into hollow 82 of plunger 66. A plunger boot termination
70 is also illustrated and is designed to receive and mate with
rupturable boot 72.
A plunger seal 74 and the boot 72 are placed onto the plunger 66
as shown in FIG. 12. The boot 72 is preferably placed onto plunger
66 so that a web 76 is just at the end of the plunger.
The plunger 66 is then inserted into the barrel 6. The thickness
of the web 76 and the tear grooves are selected to withstand normal
operating pressures within the syringe 1 yet allow relative ease
in the puncturing of the web 76 by the needle hub 2. The preferred
material for boot 72 is an elastomer. In an alternative embodiment,
the seal 74 is formed as an integral and unitary part of the plunger
66 so that the seal as provided by use of an O ring is obviated,
and the seal is accomplished by forming the ring as an integral
part of the plunger 66.
FIG. 13 is a cross-sectional view of the syringe 1 of this invention
in an operable pre-injection state. Operation of the assembled syringe
is discussed below. The syringe 1 has a barrel 6 and the plunger
66 mounted therein. The interchangeable needle 14 is contained within
the needle assembly 8 which is fixed to barrel 6 by ultrasonic
welding means or other permanent attaching means.
The interchangeable needle 14 has the needle head 12 that is releasably
fixed to the needle hub 2. The needle hub 2 is generally cylindrical
in shape and positioned within and engaged by the deformable base
4. The hub 2 has a top 46 which is preferably concave and diametrically
cylindrical. The top of enlarged needle hub 2 can be flat in some
embodiments. Below the top 46 on needle hub 2 is a diametrically
wider area or flange illustrated by 48 in FIG. 13 which is slightly
wider than top 46. In some embodiments there are a plurality of
diametrically wider areas or gradually extending flanges illustrated
as areas 315 and 317 in FIG. 41 and areas 415 and 417 in FIG. 50.
The back of needle hub 2 is defined by a plurality of decreasing
diameter steps. The steps closest to top 46 defines contacting portion
50 for contacting the energy storage means 10. By appropriately
positioning the needle hub 2 within deformable base 4 for a substantially
mating engagement, the arrangement of top 46 and flange 48 of needle
hub 2 can be substantially mated and held within deformable base
4 so that a liquid tight seal between needle hub 2 and deformable
base 4 is created.
The needle assembly 8 has contained therein the energy storage
means, illustrated as spring 10 at the top of a passageway 15 which
is in contact with contacting portion 50 of the needle hub 2. The
deformable base 4 is positioned between the base shelf 3 on the
barrel 6 and one end of the needle assembly 8 wherein the supports
21 of the base 4 contact the wall of the needle assembly 8.
Further referencing FIG. 13 the plunger 66 has a hollow 82 therein
and has the boot 72 covering an end thereof which is fluid impermeable
for forced movement of a fluid in the barrel 6 during ordinary injection.
A portion of the boot 72 is illustrated as having been torn by needle
hub 2 in FIG. 22 with the boot web 79 laying to the side in the
hollow of plunger 66.
Preferably, the plunger 66 has an enlarged thumb push 84 which,
upon completion of a compression stroke, is substantially locked
within recess 42 in the syringe body 6 by a mating head portion
94 of barrel 6 (shown in FIG. 24A).
FIG. 14 shows a side view of the needle guard 27 with a needle
assembly closing member 90 tethered at the end thereof. The closing
member 90 is attached or tethered by a breakable tab 92 which can
be of plastic construction and which is broken to remove the closing
member 90. As illustrated, the closing member 90 is preferably a
plug which is attached by the tab 92 to the needle guard 27 at an
angle wherein the tab 92 connects to the closing member 90 away
from the end of the closing member 90 which can be inserted or plugged
into the opening of the needle assembly 8 left after needle retraction.
As discussed above, the closing member 90 of this invention can
be of various types, such as a cap or a plug as shown, as long as
the opening left by needle retraction can be closed. Preferably
the opening is closed off so that a liquid tight seal is obtained.
The angular attachment of the closing member 90 preferred herein
and illustrated in FIG. 14 allows a person completing needle retraction
to handle just the needle guard 27 to insert the closing member
90 into the needle assembly 8 where the needle 14 was positioned
prior to retraction. Quite advantageously, this can be accomplished
with the user's hands always position behind the opening in the
needle assembly 8 left as a result of needle retraction.
FIG. 14A is an enlarged view of the encircled area of FIG. 14 showing
slot 25 and bead 57 used in conjunction with recess 29 (shown in
FIG. 2A) for releasably fixing the needle head with its needle into
the guard.
FIG. 15 shows the needle guard 27 placed on the needle head 12
with the needle assembly closing member 90 tethered at the tip of
needle guard 27. The guard is placed into its position by snapping
bead 57 shown in drawing 14A into recess 29 on fin 23 shown in drawing
2A. Fins 23 on needle head 12 as seen in FIG. 2 mate with slots
25 in guard 27 as shown in FIG. 14 and releasably fix the guard
27 to the needle head 12 and prevent rotation of the needle head
12 in the needle guard 27. As depicted in FIG. 15 the needle head
12 has been inserted into the open end of the passageway 15 of the
needle assembly 8. Female mating threads 20 on the needle head 12
(as shown in FIG. 2) are guided by the passageway 15 into the male
threads 22 on the needle hub 2 (as seen in FIG. 6). The needle guard
27 with needle head 12 and its needle 14 releasably fixed therein
has been twisted until the needle head 12 is substantially fixed
to the needle hub 2 and a liquid tight seal is formed between the
two parts, thus completing the assembly process. The circular groove
64 on the needle assembly 8 (shown in FIGS. 10 and 10A) serves as
an indicator that the needle head 12 is in the proper position when
the guard edge 65 (shown in FIG. 10A) on the needle guard 27 is
over the center of the groove 64.
It will be apparent to those in the art that there exists other
possible sequences of assembly other than those described that can
be used to produce the completed assembly as shown in FIG. 15 producing
the same syringe ready for operation.
FIGS. 16 through 24 show the sequence of operation of the interchangeable
needle safety syringe 1 and will now be described with reference
to FIG. 13 and FIGS. 16 through 24. As can be seen, FIG. 13 is a
cross-sectional view of safety syringe 1. For normal syringe operating
forces, the safety syringe 1 operates as any conventional syringe.
For use, the syringe 1 is filled from an ampule in a normal manner,
as standard procedure dictates. Once filled, the injection cycle
is accomplished, again according to standard practice. At completion
of the injection cycle, the plunger boot 72 is just mating with
the base 4 as shown in FIG. 16 and all fluids, which can be, are
expended from syringe 1. Before the syringe is released, or discarded,
by the user, the needle retraction cycle should be accomplished.
At the beginning of the needle retraction cycle, the syringe 1
is usually held between the index finger and the middle finger at
the support flange 40 with the thumb resting on thumb push 84
presumably the same as the syringe was held at completion of the
injection cycle. The plunger 66 is just mated with the base 4 at
the boot 72 as shown in FIG. 16.
With reference to FIG. 17 force is applied between the finger
support flange 40 and the thumb push 84. This force is transmitted
along the plunger 66 to the deformable base 4 and the supports 21.
As the force increases sufficiently, the supports 21 begin to flex
and close towards one another as shown in FIG. 17 forcing the flange
19 to ride up on the interior wall of the needle assembly 8 thus
allowing further forward movement of the base 4 and needle hub 2
with the interchangeable needle 14 contained therein.
As shown in FIG. 18 the continued application of force applied
at the plunger 66 continues to cause the supports 21 to ride up
on the interior wall of the needle assembly 8 and as the deformable
base 4 moves further, energy storage means 10 is further compressed.
The deformable base 4 moves forward until a hub block 54 on needle
hub 2 which is in translation with the base 4 comes into contact
with the top of the passageway 15 preventing further movement of
hub 2. This allows the plunger 66 to force the base 4 to deform
and pass around the now stationary needle hub 2.
With reference now to FIG. 19 as the deformable base 4 moves further
toward the end of the barrel 6 the needle hub 2 begins to protrude
from the base 4 and come into contact with and stretch the web 76
of the boot 72 on the plunger 66. Continued force causes further
translation of the base 4 and the needle hub 2 to tear web 76 of
the boot 72 positioning the needle hub 2 just inside hollow 82
of the plunger 66 while the flange 48 on the needle hub 2 remains
embedded within deformable base 4 as shown in FIG. 19. As the base
4 moves forward in the barrel 6 and transverses the barrel shelf
44 which effectively increases the inter-diameter of barrel 6 holding
forces on the needle hub 2 as a result of circumferential compression
of the base 4 in the narrower part of barrel 6 is diminished, facilitating
release of the needle hub 2 from the base 4.
With reference to FIG. 20 continued translation of the deformable
base 4 causes the flange 48 to eventually lose contact with the
deformable base 4 creating a trigger-like release of the needle
hub 2. Upon this trigger-type action, energy stored within the energy
storage means 10 is released and imparted to the needle hub 2 to
project the needle hub 2 and the replaceable needle 14 into the
hollow 82 of the plunger 66 as illustrated in FIG. 21.
Referring now to FIG. 22 it is seen that the needle hub 2 at
its top 46 contacts a capturing means 68 which elastically flexes
to permit the needle hub 2 to pass through the constriction formed
by the capturing means 68 and the interwall of the barrel 6. This
is further illustrated in FIG. 23 where the needle hub 2 with replaceable
needle 14 is shown having passed the capturing means 68 and captured
within the hollow 82 of the plunger 66 where in the head of the
needle hub 2 has moved back past the capturing means 68. At this
point, it should be noted that the plunger 66 has been substantially
locked within recess 42 of the barrel 6 by a mating head portion
94 engaging a portion of the plunger 66 near a thumb push 84 as
shown in FIG. 24A. A liquid tight seal between a plunger seal 79
and a guard ring 86 is created.
To finish the operational sequence, the closing member 90 tethered
to the end of the needle guard 27 can be inserted into opening
22 of the needle assembly 8 as shown in FIGS. 23 and 24. The closing
member 90 is forced into position by pressing the front of the syringe
against a heavy, solid object. Once the closing member 90 is lodged
into position, the closing member 90 can be separated from the needle
guard 27 with a twisting action, leaving syringe 1 as shown in FIG.
24. This closure process can therefore be advantageously accomplished
with a user's hands always remaining behind the opening left by
the retracted replaceable needle. As a result of accomplishing the
needle retraction cycle, syringe 1 is left as shown in FIG. 24.
The syringe operates on a "Force/Balance" principal as
depicted in the graph of FIG. 25. In the graph normal operation
is represented by regions I and II. In these regions limited positive
and negative forces are applied between the plunger 66 and the body
6 shown in FIG. 15 for normal operating functions of filling the
syringe and for injections. Positive forces are defined as forces
which move the plunger 66 into the syringe body 6 while negative
forces are defined as forces which pull the plunger 66 from the
syringe body 6.
Typical "filling" and "injection" cycles are
depicted in regions I and II, respectively. As long as the positive
force applied between the plunger 66 and body 6 of syringe 1 is
below threshold 39 the base 4 balances the operating force and
remains in its assembled position, as shown in FIG. 15. But, for
positive forces applied to the syringe above threshold 39 the base
4 becomes unbalanced and begins to move in the direction of needle
assembly 8. Once force above threshold 39 is applied and maintained,
operation of the syringe moves into region III, where the needle
is retracted into the plunger of the syringe. In FIG. 25 the item
numbers "83", "85", and "87" in region
III of the graph respectively refer to where in a typical device
the base 4 first begins to move, the needle hub 2 is released and
the plunger 66 becomes substantially locked into the body 6.
At least four alternative embodiments are envisioned for the syringe
invention defined herein. FIGS. 26 through 32 define alternate embodiment
1 as syringe 101 FIGS. 33 through 39 describe alternate embodiment
2 as syringe 201 FIGS. 40 through 48 describe alternate embodiment
3 as syringe 301 and FIGS. 49 through 56A describe alternate embodiment
4 as syringe 401. Each of the embodiments is substantially similar
in operation to syringe 1 and as such differences between alternate
embodiments and syringe 1 will be defined.
FIGS. 26 through 32 show sectional views of an alternative embodiment
of the replaceable needle head and needle, cooperating with an assembly
of a needle hub, base, barrel, needle assembly, and spring, where
no supports are utilized. With reference to FIGS. 26 through 32
components of syringe 101 that are different from syringe 1 taught
herein are needle assembly 109 needle hub 113 base 111 and body
105. With reference to the figures, FIG. 26 is an isolated sectional
view of the needle assembly 109 of this invention showing locking
slots 148 at the entrance of and recessed into the side wall of
a passageway 123 which extend part way through the passageway 123.
FIG. 26A is a cross sectional view of the needle assembly 109 along
line 26A--26A of FIG. 26 showing a front view of the needle assembly
109. FIG. 27 of the drawings is an isolated view of the needle hub
113 showing locking bars 156 which extend radially out from the
sidewall of the needle hub 113. FIG. 27A is a cross sectional view
of the needle hub 113 along line 27A--27A showing a front view of
locking bars 156. FIG. 28 is an isolated sectional view illustrating
the base 111 wherein flexible supports have been eliminated. Assembly
of syringe 101 is accomplished in similar manner to syringe 1. First,
as shown in FIG. 29 the needle hub 113 is inserted into and matingly
held in the base 111. The base 111 and the needle hub 113 are next
inserted into the front of the body 105 until the base 111 comes
into contact with the barrel shelf 102 as shown in FIG. 31. Placing
the base 111 into body 105 circumferentially compresses the base
onto the needle hub 113 prevents movement of the needle hub 113
in the base 111 and insures that a liquid tight seal between the
needle hub 113 and the base 111 and the base 111 and the body 105
is obtained.
With reference to FIG. 31 a spring 121 is placed over the needle
hub 113. The needle assembly 109 is next guided onto the needle
hub 113 such that the outwardly radially extending locking bars
156 on the sides of the needle hub 113 are mating with and engaged
into locking slots 148 in the passageway 123 on the needle assembly
109. The needle assembly 109 is next pushed into the open end of
body 105 which compresses spring 121 until the sidewall of the
needle assembly 109 bottoms out on the barrel shelf 114. The needle
assembly 109 is then permanently fixed to body 105 by heat staking
techniques at position 181 as shown in FIG. 31 or other suitable
permanent fixing means. With the needle assembly positioned into
the body 105 as shown in FIG. 32 a hub block 125 (as shown in FIG.
27) just contacts the bottom of locking slots 148 in the passageway
123 (as shown in FIG. 26), thus restricting further movement of
the needle hub 113 into the passageway. In the opposite direction
the needle hub 113 is restrained from movement by mating engagement
with the base 111 which is blocked by the barrel shelf 102. With
reference to FIG. 32 the next step of the assembly process is accomplished
by placing the boot 143 and a plunger seal 104 on plunger 107 and
inserting the plunger 107 into body 105 as illustrated in FIG. 32.
Before insertion of the plunger 107 into body 105 it is common
manufacturing practice to lubricate the interior wall of body 105.
Silicon is usually the lubricant of choice for this application.
Assembly is completed by placing the needle head 126 which is held
in a needle guard 112 (in identical manner to syringe 1) into the
open end of the needle assembly 109 and twisting the needle head
126 onto the needle hub 113 which completes the assembly process.
Rotation of needle hub 113 is prevented by interlocking bars 156
within slots 148 as depicted in FIG. 31. Operation of syringe 101
is substantially the same as for syringe 1 with one exception in
that needle hub 113 is fixed in passageway 123 and initial forward
movement of the needle hub 113 during the needle retraction cycle
is prevented.
With reference to FIGS. 33 through 39 an alternative embodiment
of a syringe 201 having a replaceable needle is shown. With reference
to the figures, FIG. 33 is an isolated sectional view of a needle
assembly 209 of this invention showing locking slots 248 at the
entrance of and recessed into the side wall of a passageway 223
which extend part way through the passageway 223. FIG. 33A is a
cross sectional view of the needle assembly 209 along line 33A--33A
of FIG. 33 showing a front view of the needle assembly 209. FIG.
34 of the drawings is an isolated view of a needle hub 213 showing
locking bars 256 which extend radially out from the sidewall of
the needle hub 213. FIG. 34A is a cross sectional view of the needle
hub 213 along line 34A--34A showing a front view further illustrating
locking bars 256. FIG. 35 is an isolated sectional view illustrating
a base 211 wherein flexible supports have been eliminated and a
taper 256 along the length of the base 211 is illustrated. Assembly
of syringe 201 is accomplished in similar manner to syringe 1 and
syringe 101.
Referring to FIGS. 36 37 and 38 the needle hub 213 is first inserted
into and matingly held in the base 211. The base 211 and the needle
hub 213 are next inserted into the front of body 205 until the
base 211 comes into contact with the barrel shelf 202.
Placing the base 211 into body 205 circumferentially compresses
the base 211 onto hub 213 prevents movement of the hub 213 in the
base 211 and insures that a liquid tight seal between the hub 213
and the base 211 and the base 211 and the body 205 is obtained.
A spring 221 is placed over the needle hub 213. The needle assembly
209 is next guided onto the needle hub 213 such that the outwardly
extending locking bars 256 on the sides of the needle hub 213 (seen
in FIG. 34) are mating with and engaged into locking slots 248 in
passageway 223 on the needle assembly 209 (as seen in FIG. 33).
The needle assembly 209 is next pushed into the open end of body
205 which compresses spring 221 until the top edge of the body
205 bottoms out on the needle assembly shelf 214. The needle assembly
209 is then permanently fixed to body 205 by ultrasonic welding
techniques at position 281 as shown in FIG. 38 or other suitable
permanent fixing means. With reference to FIG. 39 the needle assembly
209 positioned into the body 205 a hub block 225 just contacts
the bottom of locking slots 248 in the passageway 223 (as shown
in FIG. 33) thus restricting further movement of the needle hub
213 into the passageway. In the opposite direction hub 213 is restrained
from movement by mating engagement with the base 211 which is blocked
by a barrel shelf 202. The next step of the assembly process is
accomplished by placing a boot 243 and a plunger seal 204 on the
plunger 207 and inserting the plunger 207 into body 205 as illustrated
in FIG. 39. It is common manufacturing practice to lubricate the
interior wall of the body 205 usually with silicon, before insertion
of plunger 207 into body 205. Assembly is completed by placing needle
head 226 and needle 203 which is held in a needle guard 212 (in
identical manner to syringe 1) into the open end of the needle assembly
209 and twisting needle head 226 onto the needle hub 213 which
completes the assembly process. Rotation of the needle hub 213 is
prevented by interlocking bars 256 and slots 248 as depicted in
FIGS. 33 and 34. Operation of syringe 201 is substantially the same
as for syringe 1 with two exceptions. First, needle hub 213 is
fixed into passageway 223 and initial forward movement of needle
hub 213 during the needle retraction cycle is prevented, and secondly,
as base 211 moves forward during the retraction cycle, mating tapers
between the two parts spread, providing space at the body for the
base to more easily deform around needle hub 213.
With reference to FIGS. 40 through 48 components of syringe 301
that are different from syringe 1 taught herein is a replaceable
nose and needle cooperating with a body 305.
With reference to the figures, FIG. 40 is an isolated sectional
view of a needle assembly 309 of this embodiment of the invention
showing the base retainer slots 362 positioned at various points
on the exterior sidewall of the needle assembly 309 and threads
360 also positioned on the exterior sidewall of the needle assembly
309. FIG. 40A is a cross sectional view of the needle assembly 309
along line 40A--40A of FIG. 40 showing a front view of the needle
assembly 309. FIG. 41 of the drawings is an isolated view of a needle
head 326 showing diametrically larger areas 315 and 317 than top
310 and a spring contact 325 as described for syringe 1. FIG.
42 is an isolated sectional view of a base 311 illustrating the
mating cavity for needle head 326 and flexible supports 331 with
support flange 332. Also, illustrated are the base retainer catches
364 positioned on the back side of support flange 332. FIG. 42A
is a cross sectional view of the base 311 along line 42A--42A showing
an end view of the base 311. FIG. 43 is an isolated view of needle
303 while FIG. 44 is an illustration of spring 321. FIG. 45 is
a partial isolated sectional view of body 305 showing a taper 314
and mating threads 364. Assembly of syringe 301 is accomplished
in similar manner to syringe 1.
Referring to FIGS. 46 47 47A, and 48 the needle head 326 with
the needle 303 mounted therein, is first inserted into the base
mating cavity and held therein by the base 311 as indicated in FIG.
46. The spring 321 is placed over needle 303 until contact with
a spring contact 325 is made. The sub-assembly consisting of a base
311 spring 321 and needle head 326 is next inserted into the back
of the needle assembly 309 by guiding the needle 303 into and through
a passageway 323 of the needle assembly 309 as shown in FIG. 47.
The needle assembly 309 is next rotated relative to the base 311
to match the base retainer slots 362 on the needle assembly 309
with retainer catches 364 on the base 311 (as shown in FIGS. 47
and 47A). When the two parts are in alignment, the base 311 is forced
into the needle assembly 309 partially compressing spring 321 and
placing a shaft 316 of needle head 326 into passageway 323. Insertion
of the subassembly into the needle assembly 309 is continued until
base retainer catches 364 are latched into the base retainer slots
362 as illustrated in FIG. 47A. Once base retainer catches 364
are positioned into slots 362 position of base 311 and therefore
needle head 326 is restrained in both directions. In the one direction
movement is restrained by the base catch, while movement of the
base 311 and the needle head 326 in the opposite direction is restrained
by the flange 332 against the opposite side of the base retainer
slot 362 and the force of the spring 321 on the needle head 326
at a spring contact 325. Placing the base 311 into the needle assembly
309 also circumferentially compresses the base 311 between the needle
head 326 and the body 305 which insures that a liquid tight seal
between needle head 326 and the base 311 and the base 311 and the
body 305 is established. The needle guard 312 is next placed on
the sub-assembly, and the resulting completed assembly illustrated
in FIG. 47 represents the replaceable needle embodiment of syringe
301. The replaceable needle 303 can then be attached to, or removed
from, the body 305 by inserting the base 311 end of the assembly
into the open end of the body 305 and threading the assembly into
position with the needle guard 312 until top 366 of body 305 (as
shown in FIG. 45) mates with flat area 368 on the needle assembly
309 (shown in FIG. 40). In this position, a taper 314 on body 305
substantially mates with a taper 358 on the needle assembly 309
as shown in FIG. 48 to form a liquid tight seal between the two
parts. To remove the needle assembly from the body 305 the process
described above is reversed. Operation of syringe 301 is substantially
the same as for syringe 1.
With reference to FIGS. 49 through 56A, an alternative embodiment
syringe 401 having a replaceable nose and needle cooperating with
a body 405 is shown. With reference to the figures, FIG. 54 is an
isolated sectional view of a needle assembly 409 of this embodiment
of the invention showing base retainer slots 462 positioned at
various points on the exterior sidewall of the needle assembly 409
and threads 460 also positioned on the exterior sidewall of the
needle assembly 409. FIG. 49A is a cross sectional view of the needle
assembly 409 along line 49A--49A of FIG. 49 showing a front view
of the needle assembly 409. FIG. 50 of the drawings is an isolated
view of a needle head 426 showing diametrically larger areas 415
and 417 than top 410 and a spring contact 425 as described for
syringe 1. FIG. 51 is an isolated sectional view of base 411 illustrating
the mating cavity for the needle head 426 and flexible supports
431 with a support flange 432. Also, illustrated are base retainer
catches 464 positioned on the back side of the support flange 432.
At the front of base 411 is molded a sacrificial seal 470 used to
seal the needle assembly 409 with body 405. FIG. 51A is a cross
sectional view of the base 411 along line 51A--51A showing an end
view of the base 411 further illustrating a seal 470. FIG. 52 is
an isolated view of the needle 403. FIG. 53 is a partial isolated
sectional view of body 405 showing receiving surface 414 for the
needle assembly 409 mating threads 464 and shelf 402. Assembly
of the syringe 401 is accomplished in similar manner to syringe
1 and syringe 301. Referring to FIGS. 54 55 55A, 56 and 56A,
the needle head 426 with the needle 403 mounted therein, is first
inserted into the base 411 mating cavity and held therein by the
base 411 as indicated in FIG. 54. The spring 421 is placed over
the needle hub 426 until contact with a spring contact 425 is made.
The sub-assembly consisting of base 411 spring 421 and needle
head 426 in FIG. 54 is next inserted into the back of the needle
assembly 409 as shown in FIG. 55 by guiding needle 403 into and
through passageway 423 of the needle assembly 409. The needle assembly
409 is next rotated relative to base 411 to match base retainer
slots 462 on the needle assembly with retainer catches 464 on the
base. When the two parts are in alignment, base 411 is forced into
the needle assembly 409 substantially compressing the spring 421
and placing shaft 416 of the needle head 426 into the passageway
423.
Insertion of the subassembly into the needle assembly 409 is continued
until base retainer catches 464 are latched into the base retainer
slots 462 as illustrated in FIG. 55a. With the base 411 locked
into the needle assembly 409 a sacrificial seal 470 is positioned
at the back edge of the needle assembly 409. Once the base retainer
catches 464 are positioned into slots 462 position of the base
411 and therefore the needle head 426 is restrained in both directions.
In the one direction movement is restrained by the base catch 464
while movement of the base 411 and the needle head 426 in the opposite
direction is restrained by the flange 432 against the opposite side
of the base retainer slot 462 and the force of spring 421 acting
on the needle head at the spring contact 425.
Placing the base 411 into the needle assembly 409 also circumferentially
compresses the base between needle head 426 and body 405 which insures
that a liquid tight seal between needle head 426 and the base 411
and the base 411 and the body 405 is established. The needle guard
412 is next placed on the sub-assembly, and the resulting completed
assembly illustrated in FIG. 55 represents the replaceable needle
embodiment of syringe 401. The replaceable needle 403 can then be
attached to, or removed from, the body 405 by inserting the base
end of the assembly into the open end of the body 405 and threading
the assembly into position with a guard 412 until top 466 of body
405 (as shown in FIG. 53) mates with flat area 468 on the needle
assembly 409 as shown in FIG. 49. In this position, the sacrificial
seal 470 is compressed between the body 405 at shelf 402 and needle
assembly 409 as shown in FIG. 56A to form a liquid tight seal between
the two parts. To remove the needle assembly 409 from the body 405
the process described above is reversed. Operation of syringe 401
is substantially the same as for syringe 1.
FIGS. 57 and 58 show an elevational view of the syringe 1 before
and after needle retraction wherein an indicia has been revealed.
During the needle retraction cycle revelation and amplification
of an indicia or label such as biohazard label 512 as shown in
FIG. 58. Before the needle retraction cycle, the base 4 is under
biohazard label 512 as seen in FIG. 57 where in the label is not
readable. It is preferred that biohazard label 512 be printed in
black, or any other appropriate color, and base 4 also be the same
or substantially similar color so that biohazard label 512 is unnoticeable
to the user. It is also preferred that the boot 72 be of a different,
contrasting color. After the needle retraction cycle, the base 4
is no longer left under the biohazard label, and the boot 72 is
under the label as shown is FIG. 58. Since the plunger boot 72 is
any appropriate highly contrasting color relative to the base 4
and the biohazard label 512 such as orange when the other two are
black the biohazard label 512 is significantly revealed and amplified
and becomes very noticeable to the user or other people, as shown
in FIG. 58.
It is thus seen that this invention with the illustrative alternative
embodiments provides a novel syringe apparatus which has a needle
that interchangeable and is operable by a single hand and which
upon completion of injection captures the utilized interchangeable
needle and renders such harmless within the plunger of the syringe.
Further, such used syringe is rendered liquid tight to prevent possible
leakage of contaminated fluids and such used syringe is automatically
marked as a biohazard. As various other advantages and features
will become apparent to those of skill in the art from a reading
of the foregoing description which is exemplary in nature, such
modification and variations are embodied within the scope of this
invention.
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