U.S. patent application number 11/232029 was filed with the patent office on 2006-06-08 for safety syringe.
This patent application is currently assigned to MedSafe Technologies, LLC. Invention is credited to G. Samuel Brockway, Thomas R. Ellis, William B.S. SR. Pressly, Charles A. SR. Vaughn.
Application Number | 20060122564 11/232029 |
Document ID | / |
Family ID | 36601218 |
Filed Date | 2006-06-08 |
United States Patent
Application |
20060122564 |
Kind Code |
A1 |
Pressly; William B.S. SR. ;
et al. |
June 8, 2006 |
Safety syringe
Abstract
A syringe apparatus and process for using the same is provided,
the syringe apparatus having a barrel, a plunger movable within the
barrel, a needle assembly attached to an end of the barrel and
having a passageway therethrough, a deformable base positioned
within the barrel, flexible supports included on the deformable
base, a spring within the passageway of the needle assembly, a
hollow needle passing through the passageway, an enlarged head on
the needle, and a rupturable web on an end of the plunger, whereby
when the plunger moves through the barrel toward the needle
assembly, a fluid can be moved from the barrel through the hollow
of the needle, and continued movement of the plunger flexes the
supports and moves the deformable base downwardly until such time a
sufficient force is imparted to the rupturable web by the enlarged
head to tear the web, the deformable base then releasing the needle
due to force applied by the spring to project the needle into the
interior of the plunger. Seals are provided for making a liquid
impervious seal on both ends of the syringe after the needle is
retracted. The seal on the end left open by needle retraction is a
closing member which can be used to seal off the opening without
placing a user's hands in front of the opening. The syringe
includes indicia that is revealed upon needle retraction to label
the syringe as a biohazard. A syringe apparatus using a deformable
base, enlarged needle head and needle assembly of an alternative
embodiment is also provided wherein sacrificial supports in the
needle assembly are utilized and severed by the deformable
base.
Inventors: |
Pressly; William B.S. SR.;
(Greer, SC) ; Vaughn; Charles A. SR.; (Duluth,
GA) ; Brockway; G. Samuel; (Lawrenceville, GA)
; Ellis; Thomas R.; (Lawrenceville, GA) |
Correspondence
Address: |
J. BENNETT MULLINAX, LLC
P. O. BOX 26029
GREENVILLE
SC
29616-1029
US
|
Assignee: |
MedSafe Technologies, LLC
Lawrenceville
GA
|
Family ID: |
36601218 |
Appl. No.: |
11/232029 |
Filed: |
September 21, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10611648 |
Jul 1, 2003 |
|
|
|
11232029 |
Sep 21, 2005 |
|
|
|
09593974 |
Jun 13, 2000 |
6605073 |
|
|
10611648 |
Jul 1, 2003 |
|
|
|
09139008 |
Aug 24, 1998 |
6074370 |
|
|
09593974 |
Jun 13, 2000 |
|
|
|
08783665 |
Jan 15, 1997 |
5800403 |
|
|
09139008 |
Aug 24, 1998 |
|
|
|
08481093 |
Jun 7, 1995 |
5613952 |
|
|
08783665 |
Jan 15, 1997 |
|
|
|
08359001 |
Dec 16, 1994 |
|
|
|
08481093 |
Jun 7, 1995 |
|
|
|
07813115 |
Dec 23, 1991 |
5211629 |
|
|
08359001 |
Dec 16, 1994 |
|
|
|
Current U.S.
Class: |
604/231 ;
604/195 |
Current CPC
Class: |
A61M 2205/6081 20130101;
A61M 5/508 20130101; A61M 2005/3224 20130101; A61M 2005/3223
20130101; A61M 5/3202 20130101; A61M 2005/3106 20130101; A61M 5/502
20130101; A61M 2205/583 20130101; A61M 2005/3101 20130101; A61M
2005/3103 20130101; A61M 5/3234 20130101 |
Class at
Publication: |
604/231 ;
604/195 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Claims
1-39. (canceled)
40. A process for retracting a needle at the completion of
subcutaneous injection with a hypodermic syringe, comprising the
steps of: forcing a plunger of said syringe downwardly to force a
needle support deformable base downwardly and sever sacrificial
supports; forcing an end portion of said needle to tear a base
portion of the plunger; and propelling said needle into a hollow of
said plunger such that said needle is contained entirely within
said plunger.
41. A syringe comprising: a barrel having a first end and an
opposite second end; a plunger having a forward end and movable
within the barrel from the second end of the barrel towards the
first end, the plunger having a hollow interior communicating with
the forward end; a deformable base mounted within the barrel
intermediate the first and second end; sacrificial supports in the
barrel for supporting the deformable base within the barrel; a
hollow needle having a pointed front, extending through the first
end of the barrel and a rear end received within the deformable
base; energy storage means positioned in the barrel between the
first end and the deformable base and in engagement with the
needle; and a rupturable boot on the forward end of the plunger;
whereby a fluid is moved from within the barrel through the needle
as the plunger moves through the barrel to the deformable base, and
when the rupturable boot contacts the deformable base, continued
movement of the plunger moves the deformable base toward the first
end, the rear end of the needle thereby causing the boot to tear
and losing contact with the deformable base to allow the energy
storage means to eject the needle into the interior of the
plunger.
42. A syringe apparatus comprising: a barrel; a plunger movable
within said barrel; a needle assembly attached to an end of said
barrel and defining a passageway therethrough; a deformable base
positioned within said barrel adjacent said needle assembly and
defining a passage therethrough, said deformable base forming a
liquid tight seal between said base and said barrel; energy storage
means within said passageway; a hollow needle passing through said
passageway; an enlarged head on said needle engaged within said
passage of said deformable base; and a rupturable web on an end of
said plunger for moving a fluid within said barrel through the
hollow of said needle when said plunger is moved through said
barrel toward said needle assembly; whereby when said plunger moves
through said barrel toward said needle assembly, a fluid can be
moved from said barrel through the hollow of said needle, and
continued movement of said plunger moves said deformable base
downwardly until such time as sufficient force is imparted to said
rupturable web by said enlarged head of said needle to tear said
rupturable web, said deformable base then releasing said needle
with said enlarged head due to force applied thereto by said energy
storage means to project said needle with said enlarged head into
the interior of said plunger.
43. The apparatus according to claim 42 wherein said enlarged
needle head is cylindrical.
44. The apparatus according to claim 42 wherein said deformable
base is cylindrical.
Description
RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application of
Ser. No. 10/611,648, filed on Jul. 1, 2003, which is a Continuation
of Ser. No. 09/593,974, filed on Jun. 13, 2000, now U.S. Pat. No.
6,605,073, which is a Continuation of Ser. No. 09/139,008, filed on
Aug. 24, 1998, now U.S. Pat. No. 6,074,370, which is a Continuation
of Ser. No. 08/783,665, filed on Jan. 15, 1997, now U.S. Pat. No.
5,800,403, which is a Continuation of Ser. No. 08/481,093, filed on
Jun. 7, 1995, now U.S. Pat. No. 5,613,952, which is a
Continuation-In-Part of Ser. No. 08/359,001, filed Dec. 16, 1994,
now Abandoned, which is a Continuation of Ser. No. 07/813,115,
filed on Dec. 23, 1991, now U.S. Pat. No. 5,211,629.
BACKGROUND OF THE INVENTION
[0002] This invention relates generally to the art of syringes and
more particularly to a syringe which reduces the likelihood of
unintentional puncture or pricking of human skin. 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
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.
[0003] One such device is described in U.S. Pat. No. 4,973,316 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. 4,921,486 to DeChellis, et al. One of the earlier patents
in this regard was U.S. Pat. No. 2,460,039 issued to Scherer, et
al.
[0004] Other references disclosing devices relating to needle
retraction in a syringe include U.S. Pat. Nos. 4,9,94,034 to Botich
et al, U.S. Pat. No. 4,838,869 to Allard, and U.S. Pat. No.
5,114,410 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. While all
such devices seek the same goal of preventing accidental puncture,
considerable room for improvement exists.
SUMMARY OF THE INVENTION
[0005] It is thus an object of this invention to provide a novel
hypodermic syringe which minimizes the likelihood of accidental
puncture.
[0006] It is a further object of this invention to provide such a
syringe which, after utilization, isolates the used needle so as to
render such needle harmless, and automatically indicates that the
syringe represents a biohazard.
[0007] It is a further and more particular object of this invention
to provide such a hypodermic syringe which is operable utilizing
only one hand.
[0008] It is a further and yet more particular object of this
invention to provide such a syringe which automatically, upon the
end of an injection, retracts its needle to prevent its reuse,
while sealing the needle within the body of the syringe to prevent
leakage of residual fluids.
[0009] It is a further object of the invention to provide a simple
device, which is manufacturable in high volumes.
[0010] 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
is housed in a passageway within a needle assembly. 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 an enlarged head of the needle which
enlarged head 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 the flexible supports to flex and move over the needle
assembly, permitting the deformable base to move the enlarged head
of the needle downward until further movement of the enlarged head
is blocked by the needle assembly. With the enlarged needle head
blocked by the needle assembly, continued force at the plunger
causes the deformable base to move around the enlarged needle head.
As the deformable base moves around the needle assembly, the
enlarged needle head begins to protrude from the deformable base
and come into contact with the web on the boot of the plunger.
Continued force causes the enlarged needle head to tear the web of
the boot, positioning the enlarged needle head 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 enlarged needle head looses contact with
the deformable base, which triggers a release of energy from the
energy storage means in the passageway, projecting the needle with
its enlarged head into the hollow portion of the plunger. Once
inside the plunger, the needle 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.
[0011] In an alternative embodiment of the syringe according to
this invention, a barrel, needle assembly, needle head, and
deformable base of different structures than above are utilized
wherein the deformable base is positioned between sacrificial
supports in the needle assembly and an internal wedged end of the
barrel. Upon completion of injection, the boot contacts the
deformable base, and upon application of force at the plunger,
moves the base downward, initially breaking the liquid tight seal
between the base and the barrel. Continued application of force
causes the sacrificial supports within the needle assembly to
sever, permitting the deformable base to move the enlarged head of
the needle downward until further movement of the enlarged head is
blocked by the passageway in the needle assembly. With the enlarged
needle head blocked by the passageway, continued force at the
plunger causes the deformable base to move around the enlarged
needle head. As the deformable base moves forward, the enlarged
needle head begins to protrude from the deformable base and come
into contact with a thin, rupturable web on the boot of the
plunger. Continued force causes the enlarged needle head to
penetrate the web of the boot, positioning the enlarged needle head
just inside a hollow portion of the plunger. As the plunger moves
the deformable (base still further, the enlarged needle head looses
contact with the deformable base, which triggers a release of
energy from the energy storage means in the passageway, projecting
the needle into the hollow portion of the plunger. Once inside the
plunger, the needle is trapped by its enlarged head within the
plunger. Final movement of the plunger causes the plunger to become
captured in the barrel at the back of the syringe.
DETAILED DESCRIPTION
[0012] In accordance with this invention it has been found that a
syringe may be provided for normal operation but, which completion
of normal operation and continued movement of the plunger, results
in a triggering of the needle or cannula 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 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 can be sealed 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.
[0013] FIGS. 1 and 2 of the drawings illustrate the syringe 1 of
this invention with the needle 3 illustrated in FIG. 1 in its
normal pre-injection position. FIG. 2 of the drawings, however,
shows the final position after operation of this invention wherein
the needle 3 has been trapped and rendered harmless after the
injection has taken place, and the plunger 7 has been locked within
the barrel 5 of the syringe. The syringe 1 in accordance with this
invention has relatively few components, which along with their
function, will now be described with reference to the drawings in
sequence beginning with FIG. 1.
[0014] The syringe 1 has a barrel 5 and a plunger 7 mounted
therein. The needle 3 is contained within a needle assembly 9,
which is fixed to barrel 5 by ultrasonic welding means or other
permanent attaching means.
[0015] Needle 3 has an enlarged head 13, generally cylindrical in
shape, positioned within and engaged by deformable base 11.
Enlarged head 13 has a top 14, which is preferably flat and
diametrically cylindrical. The top of enlarged head 13 can be
concave in one embodiment. Below top 14 on enlarged head 13 are a
plurality of diametrically wider areas or gradually extending
bands, illustrated as areas 15 and 17, which are slightly wider
than top 14. The bottom portion of enlarged head 13 is
cylindrically smooth and defines a contacting portion 25 for
contacting the energy storage means. By appropriately positioning
the enlarged needle head 13 within deformable base 11 for a
substantially mating engagement, the geometries of top 14 and area
15 of enlarged head 13 can be substantially mated and locked within
deformable base 11 so that a liquid tight seal between needle head
13 and deformable base 11 is created at top 14 of enlarged head 13.
As seen in FIG. 1, all of enlarged head 13 but a portion of the
bottom portion is contained within the deformable base.
[0016] Needle assembly 9 has contained therein energy storage
means, illustrated as spring 21, within a passageway 23, which is
in contact with contacting portion 25. Deformable base 11 is
positioned between barrel base shelf 2 and one end of needle
assembly 9 wherein supports 31 of base 11 contact the end of the
needle assembly.
[0017] Plunger 7 has a hollow 41 therein and has a boot 43 covering
an end thereof which is fluid impermeable for forced movement of a
fluid in barrel 5 during ordinary injection. A portion of boot 43
is illustrated as having been torn by the needle head in FIG. 2,
with boot web 79 laying over in the front of plunger 7.
[0018] Preferably, plunger 7 has an enlarged thumb push 45 which,
upon completion of a compression stroke is substantially locked
within a mating head portion 47 of barrel 5. As seen in FIG. 2
fitting plunger 7 within barrel 5 also produces a sealing action
between plunger seal 4 and guard ring 16, preventing release of
residual fluids at the back of the syringe, left in the needle
after use. Plunger 7 has needle capturing means 49 therein which is
illustrated in FIG. 2 as preventing the release of needle 3 from
plunger 7. Also illustrated in FIG. 2 is closing member 51,
illustrated as a plug, inserted into the front of needle assembly 9
to prevent residual fluids which may drain from needle 3, after the
capture thereof, from leaking from the front of the syringe. It is
envisioned according, to this invention that various structures of
closing members can be utilized, such as the plug as shown and also
a capping member, as long as the opening left by needle retraction
can be closed.
[0019] Reference will now be made to FIGS. 3 through 11B to more
particularly illustrate the components of this invention as
described above.
[0020] FIG. 3 is an isolated sectional view of needle assembly 9 of
this invention. Passageway 23 is shown and is defined within needle
assembly 9.
[0021] FIG. 3A of the drawings is a cross-sectional view along line
3A-3A of FIG. 3 illustrating the needle assembly 9 of this
invention.
[0022] FIG. 4 is an isolated sectional view illustrating deformable
base 11 which defines a passage therethrough for passage of the
needle head, as discussed in more detail later. Deformable base 11
is designed to substantially matingly engage enlarged head 13. As
seen in FIG. 4 base wedge 6 is provided, below where top 14 of
enlarged head 13 can fit, for proper positioning of the needle in
the deformable base. Further, cylindrical barrel seals 8 are
provided to create proper sealing action between base 11 and barrel
5. The diameter and width of the barrel seals 8 can be made to
create an optimum seal, while minimizing static and dynamic
friction between base 11 and barrel 5. Also illustrated in FIG. 4
are supports 31, preferably formed as opposing, semicircular
cantilevered beams projecting from the upper body 12 of base 11.
Each support 31 has an inward engaging flange 32 for engaging a
lower portion of enlarged head 13 and an end of the needle
assembly, as shown in FIG. 1. Needle head seal 10 is further
illustrated in FIG. 4 and is where top 14 of enlarged head 13 can
fit. The diameter and width of needle head seal 10 is designed to
provide optimum sealing with top 14, while minimizing static and
dynamic friction between enlarged head 13 and base 11.
[0023] FIG. 4A of the drawings is a cross-sectional view along line
4A-4A of FIG. 4 illustrating deformable base 11. A preferred
material for base 11 is an elastomer. Supports 31 are illustrated
in the preferred embodiment as a pair of opposing, semicircular
cantilevered beams, however, it is envisioned according to this
invention that supports 31 could be connected and unitary or
divided up further.
[0024] FIG. 5 of the drawings is an elevational side view of the
energy storage means illustrated as spring 21.
[0025] FIG. 6 of the drawings is an elevational view of plunger
seal 4 illustrated in one embodiment as an O-ring seal.
[0026] FIG. 7 of the drawings is an isolated view of needle 3, or
cannula, with enlarged head 13. Top 14, wider areas 15 and 17, and
contactor 25 on the bottom portion are illustrated. Also
illustrated in phantom is the hollow portion 16 of the needle.
[0027] FIG. 8 shows a side view of a needle guard 12, with closing
member 51 attached at the end thereof. Closing member 51 is
attached or tethered by a breakable tab 52 which can be of plastic
construction and which is broken to remove closing member 51. As
illustrated, closing member 51 is preferably a plug which is
attached by tab 52 to the needle guard at an angle wherein tab 52
connects to closing member 51 away from the end of closing member
51 which can be inserted or plugged into the needle assembly after
needle retraction. As discussed above, the closing member 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 preferred herein and illustrated in FIG. 8 allows a person
completing needle retraction to handle just the needle guard to
insert the closing member into the needle assembly where the needle
was positioned prior to retraction. Quite advantageously, this can
be accomplished with the user's hands always positioned behind the
opening in the needle assembly left as a result of needle
retraction.
[0028] FIG. 9 is an isolated sectional view of boot 43 of this
invention. FIG. 9A of the drawings is a cross-sectional view along
line 9A-9A of FIG. 9 illustrating boot 43. FIG. 9B is an enlarged
sectional view of the encircled area of FIG. 9. Referring to FIGS.
9, 9A and 9B, a thin, rupturable web 79 is shown as a portion of
boot 43. To aid in the rupturing process of the web, tear groove 26
and tear groove 28, shown in FIG. 9B, are provided. The thickness
of web 79 and the tear grooves are selected to withstand normal
operating pressures within syringe 1, as shown in FIG. 1, but to
allow relative ease in the puncturing of web 79 by enlarged needle
head 13, shown in FIG. 6. The preferred material for boot 43 is an
elastomer.
[0029] FIG. 10 is an isolated sectional view of barrel 5. FIG. 10A
of the drawings is a cross-sectional view along line 10A-10A of
FIG. 10 showing finger support flange 81 of barrel 5 of this
invention. Referring to FIGS. 10 and 10A, at the finger support
flange 81 of barrel 5 is shown an undercut 47 for locking the
plunger into the barrel. At the opposite end of barrel 5, base
shelf 2 and nose shelf 14 are illustrated. These internal offsets
receive the base and the needle assembly respectively.
[0030] FIG. 11 of the drawings is an isolated sectional view of
plunger 7 in accordance with this invention. Capturing means 49 is
illustrated. Plunger boot termination 16 is also illustrated and is
designed to receive rupturable boot 43.
[0031] FIG. 11A is an enlarged sectional view of the encircled area
of FIG. 11 and illustrates cavity 30 for receiving plunger seal 4
and inclined surface 18 for fitting and substantially locking the
plunger into the body of the syringe.
[0032] FIG. 11B is a cross-sectional view along line 11B-11B of
FIG. 11 further illustrating needle capturing means 49.
[0033] Given the components described above, assembly in several
primary steps is required to produce the syringe. FIGS. 12 through
16 illustrate these steps so as to result in a finished product.
Needle 3 is first inserted into enlarged head 13. With reference to
FIG. 12, the first assembly step is accomplished by inserting
needle 3 into deformable base 11 between flexible supports 31 for a
substantially mating engagement. Base wedge 6 is positioned between
top 14 and wide area 15 of enlarged head 13 which blocks needle 3
movement in both directions. A liquid tight seal between enlarged
head 13 and needle head seal 10 on base 11 as shown in FIG. 12 is
created around the edge of top 14 of enlarged head 13. With needle
3 blocked into base 11, the next assembly step is accomplished.
[0034] In the next step of the assembly process, the subassembly in
FIG. 12 is inserted into the front end of barrel 5 as shown in FIG.
13, until base 11 contacts and is positioned against base shelf 2.
When base 11 is completely inserted as shown in FIG. 13, base 11 is
compressed circumferentially in the direction of needle head 13,
and a liquid tight seal is produced between base 11 and barrel
5.
[0035] To complete assembly of needle assembly 9 with barrel 5, as
shown in FIG. 14, the energy storage means is first placed into
passageway 23. The preferred embodiment of energy storage means is
spring 21. Needle assembly 9 is then fixed to barrel 5 by threading
needle 3 through the center of spring 21 in passageway 23 and
inserting needle assembly 9 into the front of barrel 5, until
needle assembly 9 contacts and is positioned against nose shelf 14.
Permanently joining needle assembly 9 and barrel 5 can be
accomplished by ultrasonic welding around the circumference of
barrel 5 at overlap 81, or any other permanent attaching means can
be utilized. Attachment of needle assembly 9 to barrel 5 creates a
liquid tight seal between the two parts. As a result of this
assembly step, the end of needle assembly 9 is positioned just in
contact with engaging flanges 32 of supports 31, thus preventing
movement of base 11 and needle 3 contained therein for normal
syringe use.
[0036] In the final step of assembly, plunger seal 4 and boot 43
are placed onto plunger 7 as shown in FIG. 15. Boot 43 is
preferably placed onto plunger 7 so that web 79 is just at the end
of the plunger. Plunger 7 is then inserted into barrel 5. FIG. 15A
is a partial sectional view of the end of the plunger with a
plunger seal showing an alternative embodiment wherein the plunger
seal is formed as an integral and unitary part of the plunger so
that the seal as provided by use of an O-ring is accomplished by
forming the ring as an integral part of the plunger. To complete
the assembly as shown in FIG. 16, needle guard 12 is placed on
needle assembly 9, with closing member 51 tethered at the tip of
needle guard 12. It will be apparent to those in the art that there
exists other possible sequences of assembly other than those
described herein that can be used to produce the completed assembly
as shown in FIG. 16, producing the same syringe ready for
operation.
[0037] The syringe operates on a "force/balance" principal as
depicted in the graph of FIG. 17. 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 7 and body 5,
shown in FIG. 18, for normal operating functions of filling the
syringe and for injections. Positive forces are defined as forces
which move the plunger into the syringe body, while negative forces
are defined as those forces which pull the plunger from the syringe
body. Typical "filling" and "injection" cycles are depicted in
regions I and II, respectively. As long as the positive force
applied between the plunger 7 and body 5 of syringe 1 is below
threshold 34, base 11 balances the operating force and remains in
its assembled position, as shown in FIG. 18. But, for positive
forces applied to the syringe above threshold 34, base 11 becomes
unbalanced and begins to move in the direction of needle assembly
9. Once force above threshold 34 is applied and maintained,
operation of the syringe moves into region II, where the needle is
retracted into the plunger of the syringe. In region III, points
83, 85 and 87 represent a typical device where base 11 first begins
to move, needle head 13 is released and plunger 7 becomes
substantially locked into body 5 respectively.
[0038] The sequence of operation will now be described with regard
to FIG. 1 and FIGS. 18 through 28. As can be seen, FIG. 1 is a
cross-sectional view of safety syringe 1. For normal syringe
operating forces, safety syringe 1 operates as any conventional
syringe. For use, the syringe 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, plunger boot 43 is just mating
with base 11, as shown in FIG. 18, and all fluids, which can be,
are expended from syringe 1 through the needle. Before the syringe
is released or discarded, by the user, the needle retraction cycle
should be accomplished.
[0039] At the beginning of the needle retraction cycle, syringe 1
is usually held between the index finger and the middle finger at
support flange 81, with the thumb resting on thumb push 45,
presumably the same as the syringe was held at completion of the
injection cycle. Plunger 7 is contacting base 11 at boot 43, as
shown in FIG. 18.
[0040] With reference to FIG. 19, force is applied between finger
support flange 81 and thumb push 45. This force is transmitted
along plunger 7 to deformable base 11 and supports 31. As the force
increases sufficiently supports 31 begin to flex open away from one
another as shown in FIG. 19, wherein engaging flanges 32 move away
from and lose contact with the enlarged needle head 13 and flex
open just enough to pass over passageway 23 and to allow further
movement of base 11 and needle 3 toward an end of the barrel.
[0041] As shown in FIG. 20, the continued application of force
applied to plunger 7 continues to cause supports 31 to ride up on
and around the needle assembly as deformable base 11 moves further.
As the deformable base and the enlarged needle head are forced
toward the end of the barrel, the bottom portion of enlarged head
13, which extends partially into the needle assembly prior to the
retraction process, is forced further into the needle assembly,
until wide area 17 contacts the end of the needle assembly and
prevents any further movement of the enlarged head into the needle
assembly by its greater diameter than passageway 23 within the
needle assembly. This allows the plunger to force the base to
deform and pass around the now stationary enlarged needle head.
Spring 21 is fully compressed in the process by contactor 25 of the
needle head.
[0042] With reference now to FIG. 21, as deformable base 11 moves
further toward the end of the barrel, needle head 13 begins to
protrude from base 11 and come into contact with web 79 of boot 43
on plunger 7. Continued force causes further translation of base 11
and needle head 13 to tear web 79 of boot 43, positioning enlarged
needle head 13 just inside hollow 41 of plunger 7 while wide area
17 remains embedded within deformed base 11, as shown in FIG.
21.
[0043] With reference to FIG. 22, continued translation of
deformable base 11 causes wide area 17 to eventually lose contact
with deformable base 11, creating a trigger-like release of
enlarged head 13. Upon this trigger-type action, energy stored
within spring 21 is released and imparted to needle 3 to project
needle 3 into hollow 41 of plunger 7, as illustrated in FIG.
23.
[0044] Referring now to FIG. 24, it is seen that needle 3, at its
enlarged head 3, contacts capturing means 49 which is a flexible
catch that elastically flexes to permit enlarged needle head 13 to
pass through the constriction formed by capturing means 49 and an
inner wall of plunger 7. This is further illustrated in FIG. 25
where needle head 13 is shown having passed capturing means 49 and
being captured within hollow 41 of plunger 7 wherein the needle
head will move back past the capturing means. At this point, it
should be noted that plunger 7 has been matingly and substantially
locked within barrel 5 by mating head portion 47 engaging a portion
of the plunger near thumb push 45. As shown in FIG. 26A, a liquid
tight-seal between plunger seal 4 and guard ring 16 is created.
[0045] To finish the operational sequence, closing member 51
tethered to the end of needle guard 12, can be inserted into
opening 22 of needle assembly 9 as shown in FIG. 26 and described
with reference to FIG. 8. Closing member 51 can be forced into
position by pressing it against a heavy, solid object. Once closing
member 51 is lodged into position, closing member 51 can be
separated from needle guard 12 with a twisting action, leaving
syringe 1 as shown in FIG. 26. This closure process can therefore
be advantageously accomplished with a user's hands always remaining
behind the opening left by the retracted needle.
[0046] As a result of accomplishing the needle retraction cycle as
described, syringe 1 is left as shown in FIG. 26. Also preferably
accomplished during the needle retraction cycle is revelation and
amplification of an indicia or label such as biohazard label 24, as
shown in FIG. 28. Before the needle retraction cycle, base 11 is
under biohazard label 24 as seen in FIG. 27 wherein the label is
not readable. It is preferred that biohazard label 24 be printed in
black, or any other appropriate color, and that base 11 also be the
same or substantially similar color so that biohazard label 24 is
unnoticeable to the user. It is also preferred that boot 43 be of a
different, contrasting color. After the needle retraction cycle,
base 11 is no longer left under the biohazard label, and boot 43 is
under the label, as shown is FIG. 28. Since boot 43 is any
appropriate highly contrasting color relative to base 11 and the
biohazard label, such as orange when the other two are black,
biohazard label 24 is significantly revealed and amplified and
becomes very noticeable to the user or other people, as shown in
FIG. 28.
[0047] FIGS. 29 and 30 of the drawings illustrate the syringe 101
of this invention with the needle 103 illustrated in FIG. 29 in its
normal pre-injection position. FIG. 30 of the drawings, however,
shows the net result of this invention wherein needle 103 has been
trapped and rendered harmless after the injection has taken place,
and the plunger has been locked within the barrel of the syringe.
Syringe 101 in accordance with this invention is similar to syringe
1 described above and has relatively few components. Components of
syringe 101 that are different from syringe 1 above are the
deformable base, the enlarged needle head, and the needle assembly
and the barrel.
[0048] Syringe 101 has a barrel 105 and a plunger 107 mounted
therein. Needle 103 is contained within a needle assembly 109,
which is fixed to barrel 105 by ultrasonic welding means or other
permanent attaching means.
[0049] Needle 103 has an enlarged head 113 mounted within
deformable base 111. Enlarged head 113 has a wedge portion 115 and
a circular flange portion 117. By appropriately positioning the
enlarged head 113 within deformable base 111, the geometries of the
flange portion and, wedge portion of enlarged head 113
substantially lock such enlarged head portion within the deformable
base, while also creating a liquid tight seal between needle head
113 and deformable base 111.
[0050] Needle assembly 109 has contained therein energy storage
means, illustrated as spring 121 within a passageway 123. Enlarged
needle head 113 has a contacting portion 125 which contacts energy
storage means 121. Sacrificial supports 131 position deformable
base 111 within needle assembly 109.
[0051] Plunger 107 has a hollow 141 therein and is terminated by a
boot 143 having a rupturable web 179, the boot being fluid
impermeable for movement of a fluid in the barrel during ordinary
injection. Web 179 of boot 143 is illustrated as having been
ruptured in FIG. 30.
[0052] Preferably, plunger 107 has an enlarged compression section
at thumb push 145 which, upon completion of a compression stroke,
is locked within a mating head portion 147 of barrel 105. Plunger
107 has needle capturing means 149 therein which is illustrated in
FIG. 30 as preventing the release of needle 103 from plunger 107.
Also illustrated in FIGS. 29 and 30 is an absorption means 151,
such as cotton, to collect any fluids which may drain from needle
103 after the capture thereof.
[0053] FIG. 31 of the drawings is an isolated view of needle
assembly 109 of this invention. Sacrificial supports 131 and
passageway 123 are illustrated in partial phantom.
[0054] FIG. 32 is a cross-sectional view along the line 32-32 of
FIG. 31, further illustrating sacrificial supports 131 and
passageway 123 within needle assembly 109.
[0055] FIG. 33 of the drawings is a side view of deformable base
111. A preferred material for base 111 is an elastomer. As seen in
FIG. 33, counterbore 173 and thrubore 175 are provided for proper
positioning of the needle in the deformable base.
[0056] FIG. 34 is a cross-sectional view along the line 34-34 of
FIG. 33 further illustrating deformable base 111.
[0057] FIG. 35 of the drawings is a side view of needle 103 or
cannula. Contactor 125, circular flange 117 and enlarged head 113
with wedge portion 115 are illustrated. Also illustrated in phantom
is the hollow portion 116 of the needle.
[0058] The sequence of operation of syringe 101 will now be
described with regard to FIG. 29 and FIGS. 36 through 43. As can be
seen, FIG. 29 is a cross-sectional view of safety syringe 101. For
normal syringe operating forces safety syringe 101 operates as any
conventional syringe. For use, the syringe 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, plunger 107 is just
mating with base 111, as shown in FIG. 36, and all fluids, which
can be, are expended from syringe 101. Before the syringe is
released, or discarded, by the user, the needle retraction cycle
should be accomplished.
[0059] At the beginning of the needle retraction cycle, syringe 101
is usually held between the index finger and the middle finger at
support flange 181, with the thumb resting on thumb push 145,
presumably the same as the syringe was held at completion of the
injection cycle. Plunger 107 is just mated with base 111 at boot
143, as shown in FIG. 36.
[0060] With reference to FIG. 37, force is applied between finger
support flange 181 and thumb push 145. This force is transmitted
along the plunger to deformable base 111 and sacrificial supports
131. As the force increases sufficiently, the liquid tight seal
between barrel 105 and deformable base 111 is broken, and
sacrificial supports 131 begin to fracture.
[0061] As shown in FIG. 38 further force is applied at plunger 107.
Sacrificial supports 131 are severed and deformable base 111 moves
forward, further compressing energy, storage means 121. Deformable
base 111 moves forward until circular flange 117, on needle head
113 which is in translation with base 111, comes into contact with
the end of needle passageway 123.
[0062] With reference now to FIG. 39 enlarged needle head 113 is
blocked by passageway 123, and continued force at plunger 107
causes deformable base 111 to deform and move around circular
flange 117 on enlarged needle head 113 as deformable base 111 moves
forward, enlarged needle head 113 begins to protrude from base 111
and come into contact with rupturable web 179 of boot 143,
positioning enlarged needle head 113 just inside hollow 141 of
plunger 107 while circular flange 117 remains embedded within
deformed base 111, as shown in FIG. 39.
[0063] With reference to FIG. 40, continued translation of
deformable base 111 causes circular flange 117 to eventually lose
contact with deformable base 111, creating a trigger-like release
of circular flange 117. Upon this trigger-type action, energy
stored within spring 121 is released and imparted to needle 103 to
project needle 103 into hollow 141 of plunger 107, as illustrated
in FIG. 41.
[0064] Referring now to FIG. 42, it is seen that needle 103, at its
enlarged head 113, contacts capturing means 149 which deforms to
permit enlarged head 113 to pass through the constriction formed by
capturing means 149. This is further illustrated in FIG. 43 where
needle 103 is shown captured within hollow 141 of plunger 107. At
this point, it should be noted that plunger thumb push 145 has been
locked within the mating section 147 of barrel 105. As syringe 101
is tilted downward, fluids remaining in needle 103 flow within
hollow 141, down the exterior side of passageway 123 to absorbent
means 151 where the fluids are absorbed and prevented from being
released from the interior of syringe 101.
[0065] FIGS. 44 and 45 of the drawings illustrate syringe 1 of this
invention wherein the flexible supports are not utilized. It has
been found according to this invention that syringe 1 can function
to retract the needle without supports 31 when small syringes, such
as 1 cc syringes are used.
[0066] FIGS. 46 and 47 of the drawings illustrate syringe 101 of
this invention wherein sacrificial supports 131 are not utilized.
It has been found according to this invention that syringe 101 can
function to retract the needle without sacrificial supports 131
when small syringes, such as 1 cc syringes, are used.
[0067] FIG. 48 of the drawings illustrates a preferred embodiment
of a syringe 161 according to the present invention where no
flexible or sacrificial supports are utilized. This embodiment is
particularly suitable for small syringes, such as 1 cc, and
includes a cylindrical deformable base 163 having a central passage
therethrough which matingly engages a cylindrical enlarged needle
head 165 which is attached to an end of hollow needle 167. A needle
assembly 169 is attached to an end of barrel 171 opposite an end
for insertion of plunger 173. Needle 167 passes through a
passageway defined through needle assembly 169, and an energy
storage means such as spring 173 is positioned within the
passageway. Enlarged needle head 165 includes two cylindrical
sections of different diameters with the larger section being held
entirely within base 163 prior to initiation of needle retraction
and the lower cylindrical section extending partially into the
needle assembly and having a contacting portion 175 on an end
thereof for contacting spring 173. Base 163 is biased in position
by spring 173 against shelf 177 and by friction from barrel 171
prior to initiation of needle retraction.
[0068] Needle ejection through web 179 of boot 181 occurs as
discussed with reference to syringe 1 above, which is incorporated
herein, with base 163 being forced downwardly around the needle
assembly except no supports are utilized. As base 163 moves
downwardly, the enlarged needle head tears web 179, and when
enlarged needle head 165 loses contact with base 163, needle 167 is
ejected into plunger 7.
[0069] It is thus seen that this invention provides a novel syringe
apparatus which minimizes the likelihood of accidental puncture, is
operable by a single hand and which upon completion of injection
raptures the utilized needle and renders such harmless within the
plunger and body of the syringe. 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 modifications and variations are embodied within the scope of
this invention as defined by the following appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0070] FIG. 1 of the drawings is a cross-sectional view of the
syringe of this invention in its operational state.
[0071] FIG. 2 of the drawings is a cross-sectional view of the
syringe of this invention in its post-operational state.
[0072] FIG. 3 is an isolated sectional view of the needle assembly
of this invention.
[0073] FIG. 3A of the drawings is a cross-sectional view along line
3A-3A of FIG. 3.
[0074] FIG. 4 of the drawings is an isolated sectional view of the
deformable base.
[0075] FIG. 4A is a cross-sectional view along line 4A-4A of FIG. 4
showing the cavity for the needle head and integral flexible
supports.
[0076] FIG. 5 of the drawings is an elevational side view of the
energy storage means.
[0077] FIG. 6 of the drawings is an elevational view of the plunger
seal.
[0078] FIG. 7 of the drawings is an isolated view of the needle
with it enlarged head.
[0079] FIG. 8 of the drawings is an elevational view of the needle
guard, showing the needle assembly plug tethered to the tip of the
needle guard.
[0080] FIG. 9 of the drawings is an isolated sectional view of the
plunger boot of this invention.
[0081] FIG. 9A is a cross-sectional view along line 9A-9A of FIG.
9, showing the plunger boot.
[0082] FIG. 9B is an enlarged sectional view of the encircled area
of FIG. 9.
[0083] FIG. 10 of the drawings is an isolated sectional view of the
barrel of this invention.
[0084] FIG. 10A is a cross-sectional view along line 10A-10A of
FIG. 10.
[0085] FIG. 11 of the drawings is an isolated sectional view of a
plunger in accordance with this invention.
[0086] FIG. 11A is an enlarged sectional view of the encircled area
of FIG. 11.
[0087] FIG. 11B is a cross-sectional view along line 11B-11B of
FIG. 11 illustrating needle capturing means.
[0088] FIGS. 12, 13, and 14 of the drawings are cross- sectional
subassembly views illustrating assembly of the needle, enlarged
head, base, barrel, needle assembly, and energy storage means.
[0089] FIG. 15 of the drawings is a cross-sectional view of the
plunger of this invention, showing assembly of the plunger boot and
the plunger seal on the plunger.
[0090] FIG. 15A of the drawings is a partial sectional view of the
plunger showing an alternative embodiment for the plunger seal.
[0091] FIG. 16 of the drawings is a cross-sectional view of the
completed assembly of the syringe.
[0092] FIG. 17 of the drawings is a graph depicting the
force/balance relationship upon which the syringe operation is
based.
[0093] FIGS. 18, 19, 20, 21, 22, 23, 24, 25, 26, and 26A of the
drawings are cross-sectional views of the apparatus of this
invention showing the sequence of operation, after the injection
cycle.
[0094] FIG. 27 of the drawings is an elevational view of the
syringe prior to needle retraction.
[0095] FIG. 28 of the drawing is an elevational view of the syringe
subsequent to needle retraction wherein an indicia has been
revealed.
[0096] FIG. 29 of the drawings is a cross-sectional view of an
alternative embodiment of the syringe of this invention in its
operational state.
[0097] FIG. 30 of the drawings is a cross-sectional view of the
alternative embodiment of the syringe of this invention in its
post-operational state.
[0098] FIG. 31 of the drawings is an isolated view of an
alternative embodiment of the needle assembly of this
invention.
[0099] FIG. 32 of the drawings is a cross-sectional view drawn
along line 32-32 of FIG. 31.
[0100] FIG. 33 of the drawings is a side view of an alternative
embodiment of the deformable base of this invention.
[0101] FIG. 34 of the drawings is a cross-sectional view drawn
along line 34-34 of FIG. 33.
[0102] FIG. 35 off the drawings is a side view of the needle with
an enlarged head of an alternative embodiment according to this
invention.
[0103] FIGS. 36, 37, 38, 39, 40, 41, 42 and 43 of the drawings are
sectional views of an alternative embodiment of the syringe of this
invention illustrating the sequence of operation after the
injection cycle.
[0104] FIGS. 44, 45, 46 and 47 of the drawings are sectional views
of embodiments of a syringe where no supports are utilized.
[0105] FIG. 48 of the drawings is a sectional view of a preferred
embodiment of a syringe where no supports are utilized.
* * * * *