U.S. patent number 3,896,805 [Application Number 05/412,164] was granted by the patent office on 1975-07-29 for multi-chamber syringe.
This patent grant is currently assigned to The Kendall Company. Invention is credited to Charles Z. Weingarten.
United States Patent |
3,896,805 |
Weingarten |
July 29, 1975 |
Multi-chamber syringe
Abstract
A syringe has a floating barrier seal located at approximately
the middle of the syringe chamber, thereby forming (at least) two
different chambers on opposite sides of the barrier to provide
separate storage space for (at least) two different medicines. A
hypodermic needle projects inwardly into the adjacent one of the
chambers, far enough to pierce the floating barrier after the first
medicine has been substantially all dispensed. The needle passes
through the barrier to dispense the second medicine on the other
side of the barrier, at which time there is a relief of back
pressure which otherwise would result from a compression of the
first medicine. At this time, the barrier seals the first medicine
away from the needle so that it cannot mix with or contaminate the
second medicine. A catch may be provided to prevent the barrier
from raising and thereby allows the first medicine to reach the
needle after the second medication has begun to flow.
Inventors: |
Weingarten; Charles Z.
(Evanston, IL) |
Assignee: |
The Kendall Company (Walpole,
MA)
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Family
ID: |
26944432 |
Appl.
No.: |
05/412,164 |
Filed: |
November 2, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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255099 |
May 19, 1972 |
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Current U.S.
Class: |
604/191;
604/203 |
Current CPC
Class: |
A61M
5/284 (20130101); A61M 5/32 (20130101); A61M
5/3129 (20130101); A61M 5/286 (20130101); A61M
5/19 (20130101); A61M 2005/1787 (20130101) |
Current International
Class: |
A61M
5/28 (20060101); A61M 5/31 (20060101); A61M
5/32 (20060101); A61M 5/19 (20060101); A61 () |
Field of
Search: |
;128/221,218N,218R,218D,218DA,220,215,216,DIG.5,276,218M,218NV,DIG.28
;215/6 ;206/219-222 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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996,168 |
|
Jun 1965 |
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GB |
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1,201,009 |
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Sep 1965 |
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DT |
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488,003 |
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Dec 1953 |
|
IT |
|
934,524 |
|
Aug 1963 |
|
GB |
|
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: McGowan; J. C.
Attorney, Agent or Firm: Sprunger; Powell L.
Parent Case Text
This is a continuation-in-part of my earlier filed, co-pending
application Ser. No. 255,099, filed May 19, 1972, now abandoned.
Claims
I claim:
1. A multi-chamber syringe, comprising: a cylinder having a cavity,
a plunger having one end received in the cavity, at least one
floating barrier means in said cavity forming at least first and
second fluid chambers first and second liquids in said first and
second chambers, needle means communicating with the first chamber
and projecting into said cavity a sufficient distance to puncture
said barrier means and communicate with the second chamber when
said barrier means nears the end of its travel as said syringe is
emptied, openable port means for selectively relieving back
pressure on said barrier means without mixing said liquids in said
first and second chamber, whereby said barrier means may continue
to settle after having relieved said pressure and means for
selectively opening said port means.
2. The syringe of claim 1 wherein said floating barrier means
comprises a soft plug having at least one integrally formed
circumferential piston ring and an axial bore closed by a
membrane.
3. The syringe of claim 1 wherein said port means comprises an
evacuation port in a wall of said cylinder.
4. The syringe of claim 3 wherein said evacuation port comprises an
opening having a tab associated therewith for opening said port,
and absorbent means adjacent the opening for accumulating at least
some of the liquid passing through said opening.
5. The syringe of claim 3 wherein said evacuation port comprises an
opening having a peel off closing tab associated therewith for
opening said port.
6. The syringe of claim 3 including means associated with said port
for accumulating at least some of the liquid after relief of said
back pressure.
7. The syringe of claim 1 including means for capturing said
barrier means after said puncture whereby the second chamber may be
used for extraction.
8. The syringe of claim 7 wherein said capture means comprises
means associated with the internal wall of said cylinder.
9. The syringe of claim 7 wherein said capture means comprises
means associated with the end of said needle means which punctures
said barrier means.
10. The syringe of claim 7 wherein said capture means comprises an
enlarged portion of the needle means adjacent its puncture end.
11. A syringe comprising a cylinder having a floating barrier
therein, a piston having one end received in the cylinder, a needle
extending into said cylinder to pierce said barrier with an end of
the needle at a predetermined point in the stroke of said piston,
means for capturing said barrier when punctured, whereby said
syringe may be used for injection before capture of the barrier or
for extraction after capture means for relieving pressure in the
syringe at least prior to complete passage of the needle through
the barrier.
12. A syringe assembly, comprising:
a cylinder having a fluid receiving cavity:
a plunger having one end received in one end of the cavity;
a floating barrier means received in the cavity and defining first
and second chambers, said second chamber being located intermediate
the barrier means and the plunger;
needle means adjacent the other end of the cavity, said needle
means projecting into and communicating with said first chamber,
said needle means puncturing the barrier means and communicating
with the second chamber when the barrier means is moved toward the
needle means responsive to movement of the plunger into the
cavity;
means for capturing the barrier means adjacent the other end of the
cavity with the needle means communicating with the second chamber,
whereby the plunger may be withdrawn for subsequent use of the
second chamber in pumping fluid means for relieving pressure in the
first chamber at least prior to complete passage of the needle
through the barrier means.
13. The syringe assembly of claim 12 wherein the capturing means
comprises, an enlarged portion of the needle means for retaining
the barrier means after the needle means punctures the barrier
means.
14. The syringe assembly of claim 13 wherein the enlarged portion
of the needle means comprises a cone adjacent the puncturing end of
the needle means.
15. The syringe assembly of claim 13 wherein the enlarged portion
of the needle means comprises a barb adjacent the puncturing end of
the needle means.
16. The syringe assembly of claim 12 wherein the capturing means
comprises, an enlarged portion on the inner surface of the cylinder
and located adjacent the barrier means in the second chamber after
the barrier means is punctured by the needle means.
17. The syringe assembly of claim 16 wherein the enlarged portion
comprises a plurality of bosses on the inner surface of the
cylinder.
Description
This invention relates to syringes for giving multimedicine
injections and, more particularly, to syringes which do not allow
two or more medicines to mix prior to their sequential injection
into a patient.
Syringes are used to inject medicine into the body of a human or an
animal. Usually, the injected medication is a single fluid or a
mixture, in which case the syringe has a single compartment and a
single needle. Sometimes, the medication includes two chemicals or
drugs which must be mixed immediately prior to the injection. Here,
the syringe usually has two compartments separated by a barrier
which either ruptures or opens at the time of injection so that the
injected medicine is a single chemical mixture as it passes into
the patient's body.
When it has been necessary to inject two separate and unmixed
chemicals, the customary practice has been to use two separate
syringes. This doubles the cost of preparing and administering the
mixtures for injection, and it doubles the pain by requiring two
punctures of the patient's skin.
A suggested alternative is to provide twin, rigidly interconnected
syringes which does nothing for the cost, but supposedly gives a
single sensation of pain since the two needles are physically too
close together to be perceived as more than a single point of
contact. Aside from the double cost, this twin syringe requires
greater skill on the part of the doctor or nurse administering the
medication.
The foregoing assumes the syringe is being used for injection.
However, syringes are also used for extraction by creating a vacuum
in the chamber. In essence, by reversing the process of injection
one is able to produce an extraction.
Accordingly, an object of this invention is to provide a syringe
for administering two medications which are completely separate and
unmixed at the time of injection. Here an object is to provide a
syringe having substantially the same cost as a single medication
syringe. In this connection, an object is to provide a disposable,
double compartment syringe having such a low cost that it may be
filled with two or more medications and prepackaged in a sterile
container by a pharmaceutical company.
Another object is to enable the unimpeded flow of a second
medication by precluding the back pressure which otherwise might
build from the remaining portions of the first medication. This
object is accomplished by having a point of evacuation in the first
chamber which is effective after the second medication has begun to
flow, thus enabling that chamber's residual medication to be
released.
The object, furthermore, is to convert a multiple chamber syringe
which may be used for an injection, into a single chamber syringe,
which may be used for extraction. This object is accomplished by
capturing the floating barrier dividing the two compartments at the
base of the syringe chamber. In this way, the object of converting
to a single chamber syringe is achieved.
Moreover, an object of the invention is to reduce the skill level
required to administer a multi-medication injection. Here, an
object is to reduce the patient's pain and psychological suffering
in anticipation of and during the injection.
In keeping with an aspect of this invention, these and other
objects of the invention are accomplished by a syringe having a
floating barrier therein at approximately the middle of the syringe
chamber. Two different chambers are thereby formed on opposite
sides of the floating barrier to separate the two different
medications. A single hypodermic needle projects inwardly into the
bottom of a first of the chambers far enough to pierce the floating
barrier after substantially all of the first medication has been
dispensed. The needle passes through the barrier to thereafter
dispense the second medication on the other side of the barrier. In
this way, the barrier seals the first medication away from the
needle so that it cannot mix with or contaminate the second
medication. At this time, the residual medication is released
through a point of evacuation of the first chamber, thus precluding
back pressure from the second medication. Moreover, if desired, the
floating barrier may be captured at the base of the chamber, thus
enabling the syringe to be used for extraction.
The nature of a preferred embodiment of the invention may be
understood best from an inspection of the attached drawings
wherein:
FIG. 1 is an exploded view, in perspective, of the inventive
syringe;
FIGS. 2-5 are stop motion views schematically showing how two
medications are separately dispensed so that neither mixes with or
contaminates the other prior to injection;
FIG. 6 schematically shows the first embodiment of evacuating the
remainder of a first medication after it is no longer being
injected into a patient;
FIG. 7 perspectively shows a second embodiment of the needle
assembly for evacuation of medication;
FIG. 8 shows perspectively a third embodiment with absorbent
material to accumulate escaping medication and prevent a dribbling
of the first medication at the port;
FIG. 9 is a cross section view of a fourth embodiment utilizing the
syringe tube as a point for a weakened rupture area;
FIG. 10 perspectively shows a fifth embodiment with a weakened area
in the needle assembly; and
FIGS. 11-13 are partly cross sectional and partly perspective views
of several embodiments for capturing the floating barrier in order
to enable the syringe to be used for evacuation.
This is a very sophisticated syringe into which many optional
features can be easily incorporated. One such option provides an
evacuation port which will preclude any buildup of back pressure.
This port can be a weakened wall structure or a stationary outlet
with any of various forms of peel off tabs. Due to the equal
effectiveness of any such means, the manufacturer may select the
one means which is suited to his manufacturing or processing
procedure. Another easily incorporated option enables this syringe
to be used for extraction as well as injection by either simply
modifying the design of the needle or the inside wall of the
chamber. Again this choice allows the use of the most economical
means for the manufacturers facilities.
The inventive syringe 20 comprises a needle assembly 21, a cylinder
22, a floating barrier seal 23, and a plunger assembly 24. The
needle is separated into first and second parts 26,27,
respectively. The first part 26 is sharpened and adapted to pierce
the skin of a person or animal receiving the medication. The second
part 27 of the needle projects into the cylinder 22 for a distance
which is adequate to puncture the barrier 23 when it teaches the
bottom of the cylinder. A preferably plastic collar 28 is firmly
attached to the needle 21 at the junction point between the two
parts 26, 27. The collar 28 includes two oppositely disposed ears
29, 30 which cooperate with internal threads in the syringe to
attach the needle thereto.
The cylinder 22 is an elongated hollow tube of uniform cross
section, terminated at the bottom in an internally threaded coupler
35. Concentrically positioned inside coupler 35 is a tube 36 having
an axial opening therein to receive the needle 27 with a
sufficiently tight seal to preclude leaking. The threads 37 inside
the coupler 35 engage and receive the ears 29,30 on the collar 28.
Thus, as the assembly 28 is rotated, the two parts 28,35 come
together with a tight seal.
The upper end of the cylinder 22 has opposing tabs 38, 39 which are
held by the index and middle fingers of the person administering
the injection. The upper end 40 of the cylinder 22 is beveled to
provide a conical entrance for guiding and directing the barrier 23
and plunger 24 members upon entrance into the cylinder. The entire
unit is preferably made from low cost, this-walled, transparent
plastic material so that the person administering the injection can
watch the operation to be sure that the medications are properly
fed into the patient.
According to one aspect of this invention, a floating barrier
member 23 is provided for forming two separate chambers in the
tube. Preferably, this barrier is a soft rubber plug which has two
longitudinally displaced piston rings 41,42 for making a good seal
against the interior wall of the cylinder 22. The bottom 44 of the
plug is somewhat conical to help guide it on its entrance into the
cylinder 22. An axial bore 45 almost completely pierces the plug
forming the floating barrier member 23. However, the bottom of the
bore 45 does not quite extend through the bottom of the plug.
Therefore, the bottom of the bore 45 is covered by a thin membrane
46 to prevent any fluid from passing through the barrier.
The plunger assembly 24 comprises a ram rod 50 having a soft rubber
plug 51 attached to the bottom and a thumb pad 52 attached to the
other end. The plugs 23 and 51 are almost identical, both slide
inside the cylinder 22.
The method of its use is illustrated by the stop motion views of
FIGS. 2-5. Preferably, a pharmaceutical manufacturer loads the
inventive syringe in his laboratory or factory by depositing a
first medicine 54 in the bottom of the cylinder 22. Then, the
barrier 23 is placed in the tube and brought down into contact with
the top of the medicine surface, to eliminate all entrapped air.
One way of doing this is to invert the syringe, allow the entrapped
air to escape through a tube located intermediate the barrier 23
and cylinder 22, and then to seal the tube.
After the first medicine 54 is loaded into the first compartment, a
second medicine 55 is loaded into the second compartment. Then the
plunger assembly 24 is brought down into contact with the upper
surface of the second medicine, and all entrapped air is withdrawn.
One way to withdraw the entrapped air is to slip a small tube of
hypodermic needle stock between the soft rubber plug 51 and the
inside surface of the cylinder 22 and to vacuum pump the air from
the upper chamber. The inventive syringe (FIG. 2) is now preloaded
with two completely separated medications 54,55, held securely
apart, one from the other.
As the injection is given (FIG. 3), only the first medicine passes
out of the chamber 22 and through the needle 26, into the patient.
As the first medicine is exhausted, the floating barrier 23 engages
and is pierced by the upper end 27 of the needle 21. It is easy to
so pierce the floating barrier since only the thin membrane 46 is
present at this point. Thereafter, the needle end 27 is in the bore
45 which provides an unimpeded passage for the medicine in the
upper chamber. The rubber-like material of the floating barrier
surrounds and seals the outside of the needle 27 and prevents any
more of the first medicine 54 from passing through the needle.
At this time (FIG. 4), the second medicine 55 passes through the
needle 27 and into the patient receiving the injection. The second
medicine is not mixed with or contaminated by the first medicine at
any time before or during the injection.
At the bottom of the stroke (FIG. 5), the plug 51 reaches the top
of the barrier 23 or the needle 27, where it terminates the flow of
the medicine through the needle. The medicine is now exhausted, and
the spent syringe is discarded.
It is apparent that the same principle may be extended to an
administration of a larger number of medicines by increasing the
number of floating barriers and, therefore, the number of separate
compartments inside the cylinder 22. The membrane member 46 is thin
enough and the rubber plug 23 is soft enough to admit the second
medicine 55 to the needle. However, sometimes the first medicine 54
entrapped under the floating barrier 23 should be evacuated to
relieve pressure and to allow the barrier 23 to settle further into
the cylinder 22. This is especially true if there are two or more
floating barriers. The first barrier must settle to allow the
second barrier to be pierced by the needle 27.
Therefore, another aspect of this invention is to insure the flow
of medication after the barrier reaches the needle top by relieving
any possible back pressure in the first chamber. This is
accomplished by incorporating a port for evacuation of the first
chamber, into the design inventive syringe 20. There are several
possibilities for both the placement of this port and a method of
evacuation (FIGS. 6-10).
The first embodiment involves a weakening of cylinder 22 at a point
60 in the entrapped area 61. An adjacent chamber 62 is positioned
to communicate with the entrapped area 61 when the weakened point
60 ruptures. As the first medicine 54 is ejected from the cylinder
22, the pressure does not exceed the rupture strength of the
weakened area 60. However, when the medication 54 flow is blocked
by the needle end 27 passing through the floating barrier, the
fluid pressure builds in the entrapped area 61. Weakened area 60
ruptures under the augmented pressure, and the entrapped medication
flows from area 61 into a closed and, perhaps, evacuated chamber
62. As the fluid flows from area 61, the barrier 23 settles further
into cylinder 22 in order to enable the needle end 27 to properly
perform its penetration function. There cannot be a reverse flow
since the punctured membrane 46 of the floating barrier 23 seals
itself around the outside periphery of the needle. Moreover, any
pressure differential is such that the flow will be from the
cylinder 22 into the chamber 62.
A second embodiment of a syringe device with an evacuation port
(FIG. 7) has the location of the evacuation port 74 in collar 28 of
the needle assembly 21. This evacuation port 74 has a flexible
plastic peel off or otherwise removable tab 70. Preferably, an
adhesive is applied to a portion of the removable tab 70 to form
adhesive cover portion 71 which is large enough to cover the port
74. This tab is affixed to collar 28, over evacuation port 74, thus
sealing it from premature evacuation of the first medication 54
during the injection thereof. The nonadhesive edge of the removable
tab 70 forms tab grip 72. By holding tab grip 72 between index
finger and thumb or by catching it with a fingernail, one can
easily peel the adhesive cover 71 from collar 28. This procedure is
used to release entrapped medication 54. After peeling the
removable tab 70 from the collar 28, any entrapped medication 54
flows through the evacuation port 74, thus relieving back
pressure.
Yet another embodiment for evacuation (FIG. 8) is a variation of
the second embodiment (FIG. 7). This variation provides a means for
accumulating or sponging up the first medication 54 after its
release through evacuation point 74. Here the peel off tab 76 is
somewhat in the nature of an adhesive bandage. A non-releasable
adhesive binds the straight or vertical fastener portion 80, to the
plastic collar 28. Bulge 78 holds a pad of absorbent material 82 in
a position to catch the medication at port 74 when the syringe is
in a generally vertical position. Therefore, when first medication
54 is released, by pushing back the tab portion 71, it is soaked up
by absorbent material 82.
Still another embodiment for total evacuation (FIG. 9 and 10) is
essentially the first embodiment (FIG. 6) without provision of an
evacuation chamber 62. Here, weakened area 86 in the syringe
ruptures when pressure builds from first medication 54 becoming
entrapped under floating barrier 23. However, instead of utilizing
an adjacent chamber, the entrapped medication simply flows from
cylinder 22, thus enabling floating barrier 23 to settle. In FIG.
10, the location of the weakened wall structure 88 is in the collar
28 of the needle assembly. The choice of location, with comparable
effectiveness, enables a manufacturer to choose the position best
suited to its manufacturing techniques.
A further aspect of this invention is to provide a syringe which is
not only capable of injecting, but also of extracting. Therefore,
the multiple chamber inventive syringe 20 is made capable of
converting itself into a single chamber syringe. This is
accomplished by capturing the floating barrier 23 at the base of
cylinder 22 thus enabling inventive syringe 20 to perform as if it
were a single chambered device.
As shown in FIG. 12, a capture means is provided in the form of two
or more bosses or knobs 92 and 94 which are molded on the inside
surface walls of the cylinder 22. Their distance from the base of
cylinder 22 is slightly greater than the height of floating barrier
23. These bosses or knobs 92 and 94 are small enough to enable the
flexible material at piston rings 41 and 42 to slide over them
during injection; yet large enough to trap floating barrier 23 at
the base of cylinder 22 during extraction. The lower and upper
edges of the bosses 92, 94 may be shaped to enable the barrier to
be captured and yet to preclude any release thereof. The trapping
of floating barrier 23 converts cylinder 22 into a single chamber
and therefore enables the inventive syringe 20 to be used for
extraction, after evacuation of second medicine 55.
In FIG. 11, the capture means is a cone 90 preferably made by an
expansion of a hypodermic needle. It could also be a separate piece
slipped on over the needle and dimpled in place. Cone 90 is
positioned at the top of second part 27 at needle to trap floating
barrier 23 at base of cylinder 22. The diameter of the base of cone
90 is formed relative to the diameter of the axial bore 45 for
enabling it to trap floating barrier 23 after clearing the top of
it. The soft rubber construction of floating barrier 23 affords
little resistance as cone 90 passes through axial bore 45.
In the FIG. 13 modification, the design of the needle's second part
27 includes a barb-like capture means. Here, the tip of the second
part 27 is bent back upon itself to form a hook 96. The top end of
the hook may be sharpened to facilitate a penetration of the
barrier. Hook 96 holds floating barrier 23 stationary after
clearing the top of it. Since the materials of both the needle's
second part 27 and floating barrier 23 are quite flexible, little
resistance is encountered as hook 96 passes through axial bore
45.
The wall of the bent needle may be broken at the top or it may be
left intact so that medication centers the needle at the barb end
of the hook, which is pointing downward in FIG. 13. Due to the
pressure of medication flowing around the needle, the medication
may enter the barb end of this point as effectively as the end of a
straight hypodermic needle. This enables manufacturers to simply
use a bent section of conventional hypodermic needle stock, rather
than to produce a special closed end.
It should be understood that modifications may be made without
departing from the scope of the invention. Therefore, the appended
claims should be construed to cover all equivalent structures.
* * * * *