U.S. patent number 3,904,060 [Application Number 05/445,834] was granted by the patent office on 1975-09-09 for three barrier closure system for medical liquid container.
This patent grant is currently assigned to American Hospital Supply Corporation. Invention is credited to Charles J. McPhee.
United States Patent |
3,904,060 |
McPhee |
September 9, 1975 |
Three barrier closure system for medical liquid container
Abstract
A parenteral liquid bottle with a three barrier closure system
that (1) has first and second barriers that withstand pressure
differentials of 10 psi (0.70 Kg/cm.sup.2) during and after steam
sterilization and (2) all three barriers open easily with manual
force. The first barrier is a puncturable diaphragm hermetically
sealing off on inner portion of an opening through an inner closure
of the bottle. The second barrier is a peelable foil hermetically
sealing off an outer portion of the opening through the inner
closure. The third barrier is a tortuously vented outer cap that
fits over the first two hermetic barriers and is secured to the
bottle by a series of manually frangible webs.
Inventors: |
McPhee; Charles J. (Sylmar,
CA) |
Assignee: |
American Hospital Supply
Corporation (Evanston, IL)
|
Family
ID: |
23770370 |
Appl.
No.: |
05/445,834 |
Filed: |
February 26, 1974 |
Current U.S.
Class: |
215/251; D24/121;
604/403; 215/DIG.3 |
Current CPC
Class: |
B65D
51/18 (20130101); B65D 2251/0087 (20130101); B65D
2251/0015 (20130101); B65D 2251/0062 (20130101); B65D
2203/04 (20130101); Y10S 215/03 (20130101) |
Current International
Class: |
B65D
51/18 (20060101); B65D 041/62 (); B65D
051/18 () |
Field of
Search: |
;215/251,DIG.3,320,204
;128/272 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Ross; Herbert F.
Attorney, Agent or Firm: Barger; Larry N. Merrick; Robert
T.
Claims
I claim:
1. In a thermoplastic steam sterilizable medical liquid container,
having a flange on a neck portion and an inner closure and an outer
closure, the improvement of: a tube on the inner closure with a
passage therethrough; a first hermetic seal closing the passage; a
second hermetic seal closing the passage externally of the first
hermetic seal; said outer closure encloses the first and second
hermetic seals; said outer closure having an outwardly extending
brim fused to said flange and includes a vent that equalizes
pressure inside and outside the outer closure, so that the outer
closure is relieved of differential pressure stresses.
2. The combination as set forth in claim 1, wherein the first
hermetic seal remains closed when subjected to a pressure
differential of 10 psi (0.70 Kg/cm) exerted across the first
hermetic seal.
3. The combination as set forth in claim 1, wherein the second
hermetic seal remains closed when subjected to a pressure
differential of 10 psi (0.70 Kg/cm.sup.2) exerted across the second
hermetic seal.
4. The combination as set forth in claim 1, wherein the vent is a
tortuous passage through the outer closure.
5. The combination as set forth in claim 1, wherein the outer
closure has a manually frangible section for opening the outer
closure to gain access to the first and secoind hermetic seal means
on the inner closure.
6. The combination as set forth in claim 5, wherein the manually
frangible section includes an annular venting opening about the
outer closure with one or more frangible webs integral with the
outer closure and extending across the vent opening.
7. The combination as set forth in claim 1, wherein the tube is a
dispensing outlet tube and includes a spike gripping tubular
sleeve.
8. The combination as set forth in claim 7, wherein the spike
gripping sleeve has an inner wall that tapers inwardly toward an
interior of the container.
9. The combination as set forth in claim 8, wherein the spike
gripping sleeve is laterally expandable for grippingly receiving a
tubular administration spike.
10. The combination as set forth in claim 9, wherein the first
hermetic seal in puncturable thermoplastic diaphragm formed
integrally with and closing off a passage through the tubular spike
gripping sleeve.
11. The combination as set forth in claim 10, wherein the spike
gripping sleeve has an integral annular rib extending below the
diaphragm.
12. The combination as set forth in claim 10, wherein the tube
includes an annular support section with the spike gripping sleeve
disposed within and integrally formed with this annular support
section.
13. The combination as set forth in claim 12, wherein the tube
includes an annular space between the annular support section and
the spike gripping sleeve disposed therein.
14. The combination as set forth in claim 1, wherein the second
hermetic seal is a manually peelable thermoplastic-metal foil
bonded to an outer end of the tube.
15. The combination as set forth in claim 1, wherein the outer
closure is a cap having a diameter substantially greater than a
diameter of the tube section, whereby forces to open the first and
second hermetic seals are concentrated in areas substantially
smaller than the outer closure.
16. The combination as set forth in claim 1, wherein the tube is an
outlet tube and the inner closure also includes an additive port
closed by a puncturable resealable diaphragm separate from the
outlet tube and additive medication can be added to the container
through this additive port.
17. The combination as set forth in claim 16, wherein the
puncturable resealable diaphragm is externally sealed off by a
hermetic barrier disposed within the outer closure.
18. The combination as set forth in claim 17, wherein the
puncturable resealable diaphragm is disposed in an additive tube
integrally formed with the inner closure.
19. The combination as set forth in claim 18, wherein the additive
tube section has hermetic barrier external of the puncturable
resealable diaphragm.
20. The combinationn as set forth in claim 19, wherein the hermetic
barrier is a thermoplastic-metal foil.
21. The combination as set forth in claim 1, wherein the outer
closure is a thermoplastic cap and is secured to the container by a
plurality of webs each of which has a cross-sectional area less
than 0.0004 in.sup.2 (0.0026 cm.sup.2) for easy manual breakage by
twisting or cocking the outer cap relative to the container.
22. The combination as set forth in claim 1, wherein the inner
closure has an additive tube, the first hermetic barrier is a
puncturable resealable diaphragm, and the second hermetic barrier
is a metal-thermoplastic laminate foil, both of which are sealed to
the additive tube.
23. For handling and dispensing a sterile medical liquid the
combination of: a thermoplastic bottle having a neck with an outlet
passage therethrough; an integral thermoplastic flange integral
with this neck; an inner closure permanently sealed to the
container neck; said inner closure having an outlet tube formed by
an annular support section and a spike gripping tubular sleeve
integral with and disposed within the annular support section; a
puncturable diaphragm integrally formed with the spike gripping
sleeve and forming a first hermetic barrier to a dispensing passage
that extends through the spike gripping sleeve; a
thermoplastic-metal foil having a thermoplastic surface bonded to
an outer end of the dispensing tube forming a second hermetic
barrier across the dispensing passage through the spike gripping
sleeve; an additive tube integrally formed with the inner closure;
a puncturable resealable diaphragm sealing off a passage through
the additive tube through which additive medications can be
injected into the bottle; a hermetic seal across the additive tube
externally of the puncturable resealable diaphragm, said hermetic
barrier being a thermoplastic-metal foil; a third barrier in the
form of a cap having a top wall, a tubular sidewall, and a
laterally extending brim fitting over and enclosing both the outlet
tube and the additive tube; said cap brim being permanently bonded
to the bottle neck flange and supporting the outer cap's top wall a
distance above the thermoplastic-metal foil; said outer closure
having a tortuous vent at a juncture between the tubular side wall
and the cap brim; and a series of manually frangible web sections
connecting the sidewall to the flange of the outer closure.
Description
BACKGROUND
Sterile medical liquid such as parenteral solution is commonly
infused into a patient's vein from a container hanging above the
patient. The sterile liquid flows by gravity through a tubular
administration set connected at one end to the container and at an
opposite end to a venous needle in the patient.
Sterile parenteral solutions, such as 5% dextrose normal saline
etc. are supplied to the hospital in sealed sterilized containers.
For many years these containers have been glass bottles. Recently
efforts have been made to change to thermoplastic containers to
reduce the problems of breakage, high freight costs, and the
requirement for an air inletting system with a rigid glass bottle.
The Applicant has invented an improved collapsible plastic bottle
which is the subject of a copending application entitled
"THERMOPLASTIC BOTTLE WITH `CONTROLLED LATERAL COLLAPSE` AND METHOD
OF DISPENSING LIQUID THEREFROM", Ser. No. 445,836 2-26-74. That
application involves the structure of the bottle itself and its
particular collapsing feature.
This application has to do with a novel dispensing closure system
for this collapsible thermoplastic bottle. Previous closure systems
for rigid glass bottles are not well suited for thermoplastic
bottles. A typical glass bottle closure is shown in U.S. Pat. No.
2,665,024 and has a rubber stopper wedged into the neck of a glass
bottle and held to the bottle by a crimped annular metal band. The
forces exerted on a thermoplastic bottle neck by the compressed
rubber stopper and crimped metal band could sufficiently deform the
thermoplastic bottle neck with time to cause a crack or opening
through which bacterial contamination could grow. To avoid
excessive pressures tending to deform a thermoplastic neck
frangible thermoplastic closures have been bonded directly to the
thermoplastic bottle. One such closure system is described in U.S.
Pat. No. 3,394,831 which is owned by the Assignee of the present
application. In such a closure the outer cap formed a hermetic seal
and was capable of withstanding pressure differentials of 10 psi
between an inside surface and an outside surface of the outer cap
during and after steam sterilization. The cap that would withstand
such a pressure differential was sometimes hard to manually
fracture to gain access to the bottle's inner closure.
SUMMARY OF THE INVENTION
In this invention a triple barrier system has been provided with
first and second barriers that withstand pressure differentials
during and after steam sterilization and a third barrier attached
after steam sterilization, which third barrier protects the first
two barriers. All three barriers are easy to open with manual
force. In the present closure system there is an inner closure
sealed across the neck of the thermoplastic bottle. This inner
closure has a dispensing outlet tube with a first hermetic seal at
an inner portion and a second hermetic seal at an outer portion. As
used in this application, a hermetic seal is defined as a seal that
will not pass either gas or liquid. These two hermetic barriers
withstand pressure differentials of 10 psi (0.70 Kg/cm.sup.2) and
are capable of withstanding steam sterilization without rupturing.
The first and second barriers are easily opened with manual force
because each barrier is a very small area, approximately one-half
inch (1.27cm) diameter or less.
The third barrier is an enlarged cap, approximately 11/2 inch (3.81
cm) diameter that fits over the first two hermetic barriers and is
sealed to the thermoplastic bottle without exerting any significant
sealing pressure on the first and second hermetic seals. The third
barrier includes a tortuous air vent system for equalizing pressure
inside and outside the outer cap so that as temperature and
atmospheric pressure change during storage, there is no pressure
differential exerted between the outer caps interior and exterior
surfaces. This outer cap has a series of very thin frangible webs
extending across the tortuous air vents. The outer cap or third
barrier does not form a hermetic seal and is not subjected to
stresses from pressure differentials, and since the outer cap is
spaced from the first two barriers, these two barriers do not exert
an internal force on the outer cap. Thus the webs need be only
strong enough to prevent accidental breaking of the cap during
storing and handling. Immediately before use the outer cap is
simply twisted or cocked to manually break it off to gain access to
the two small diameter hermetic seals.
This triple barrier system provides a hermetically sealed closure
that withstands pressure differentials of 10 psi and is also easy
to open.
THE DRAWINGS
FIG. 1 is a front elevational view of the thermoplastic bottle as
it is supplied to the hospitals;
FIG. 2 is an enlarged perspective view of the outer closure cap
showing its vent structure;
FIG. 3 is a perspective view of a top portion of the bottle showing
the outer cap removed from the bottle;
FIG. 4 is an enlarged view of a top portion of the bottle and
closure system with the outer cap shown in cross-sectional
view;
FIG. 5 is a further enlarged sectional view showing the vent
structure of the outer cap;
FIG. 6 is a front elevational view of a top portion of the bottle
closure system showing the outer cap being removed by a cocking
motion; and
FIG. 7 is an enlarged sectional view of the dispensing tube with
the second barrier opened to expose the first barrier.
DETAILED DESCRIPTION
Referring to the above drawings FIG. 1 shows the bottle 1 that has
been sterilized and in the condition it is supplied to the
hospital. In this Figure the bottle 1 is standing upright on a
series of feet, two of which are shown as 2 and 3. A recess 4 in a
base of the bottle between feet 2 and 3 houses a hinged hanger 5.
At an upper end of the bottle 1 is neck 6 with an external flange
7. An outer cap 8 is connected to this flange 7. Sealed within the
bottle is a sterile medical liquid 9 and sterile air 10. A front of
the bottle has a label 60c located between calibrations 60a and
60b.
The outer cap 8 is shown in more detail in FIG. 2. Here the cap has
a top wall 11, a cylindrical side wall 12 and a laterally
protruding external brim 13. Around the side wall 12 are a series
of ribs 14 that aid in gripping the cap during its removal. At a
juncture between side wall 12 and brim 13 are a series of
circumferential vents 15 and 16. Between these vents are a series
of frangible web sections, two of which are shown as 17 and 18.
After the bottle has been received by the hospital and is ready for
use, the nurse or physician grasps the outer cap 8 and with either
a twisting motion or a cocking motion breaks off the outer cap 8.
This break occurs at the frangible webs, two of which are shown at
17 and 18. When this occurs the brim 13 which is fused to flange 7
remains with the bottle. Cap 8 can then be lifted from the bottle
as shown in FIG. 3 to expose an inner cap structure of the closure.
This inner cap structure includes a transverse wall 20 with an
upstanding collar portion 21 sealed to a neck of the bottle in a
hermetic fusion joint. Integral with the transverse wall 20 and
extending upwardly therefrom is a dispensing tube 22 and an
additive tube 23. The outer ends of these two tubes are
hermetically sealed by a peelable thermoplastic-metal foil 24.
The structure of the triple barrier closure system is shown in more
detail in FIG. 4. The triple barrier system will first be described
relative to dispensing tube 22. Here the dispensing outlet tube,
shown generally at 22, includes two tubular sections. First there
is an outer tubular support section 32 that is secured at its lower
end to transverse wall 20 and secondly there is a sleeve section 30
disposed within and spaced from tubular support section 32. The
tubular sleeve section and the tubular support section are
integrally joined at their upper ends to combine and form the
dispensing outlet tube 22. The sleeve section 30 is laterally
expandible and tapers inwardly to grip a spike of an administration
set as it proceeds toward a lower end of sleeve section 30. This
lower end is sealed off by an integral puncturable first barrier 31
of a non-resealable thermoplastic material which is exposed to the
liquid contents within the bottle. As shown in FIG. 7, the sleeve
section 30 has an inner flange at its upper end that seals to
tapered spike 50 prior to puncture of diaphragm 31, so that no
liquid will leak from the container.
A second hermetic barrier is comprised of the laminated
thermoplastic-metal foil 24 that seals off the upper end of
dispensing tube 22. The thermoplastic portion of foil 25 is
peelably bonded to the outlet tube. Preferably the foil 24 is
severed into a first section sealed to the outlet tube 22 and a
second section 30 of the dispensing tube 22 contains a given mass
of air. There is also a mass of air within the bottle below
puncturable diaphragm 31. Both the first barrier 31 and the second
barrier foil 24, are hermetic seals that can withstand pressure
differentials of at least 10 psi (0.70Kg/cm.sup.2) without
rupturing or forming a bacterial leak.
The third barrier in FIG. 4 is an enlarged outer cap 8. As
previously described this outer cap 8 has a top wall 11, a
cylindrical sidewall 12 and a brim 13 that is fused to flange 7.
The tortuous vent 15 at a juncture between the sidewall and brim
allows air to pass freely in and out of the outer cap as pressures
change during storage. This equalizes pressure inside anad outside
outer cap 8, so that no extraordinary strain is placed on frangible
webs 17 and 18 during the pressure changes. Also since the top wall
11 of outer cap 8 is spaced from the first and second hermetic
seals there is no strain placed on frangible webs 17 and 18 by the
first and second hermetic seals. Thus the web as illustrated by 17
and 18 can be very thin with each having a cross-sectional area
less than 0.0004 in.sup.2 (0.0026 cm.sup.2). The webs need be only
strong enough to resist premature breakage during handling and
storage. They do not need to withstand pressure differentials
during steam sterilization, as do the first and second
barriers.
In this invention the large diameter outer cap, approximately 11/2
inch (3.81 cm) in diameter, does not need to be broken loose about
its entire circumference. Only the very thin webs, such as 4 to 6
in number, need to be broken for removal of the cap. Thus the
opening forces are greatly reduced from a non-vented cap structure,
so the nurse or physician can easily break off the outer cap to
gain entrance to the two hermetic seals. The hermetic seals 31 and
34 are very small in area, each less than one-half inch (1.27 cm)
in diameter, so that manual rupturing forces at these barriers are
concentrated at a precise location. This makes the critical
hermetic seals much easier to open than if they were of a large
diameter, such as the diameter of the outer cap.
The tortuous vent of the outer closure is shown in more detail in
the enlarged view of FIG. 5. The torous nature of this vent resists
bacterial transmission, because bacterial growth or movement does
not readily progress through a series of sharp angled turns. While
the third barrier of the outer cap is not a hermetic barrier it
does provide protection for the first and second hermetic seals and
greatly reduces the chance of airborne or water borne bacteria
coming in contact with the second hermetic seal (foil 24) prior to
opening the outer cap.
The details of the air path through tortuous vent 15 is shown in
FIG. 5. Here the cylindrical sidewall 12 is spaced slightly from an
upstanding collar portion to provide an air path. A brim portion 13
of an outer closure 8 is fused to flange 7 at a fusion joint 21.
The tortuous vent, shown generally by numeral 15, is formed by a
recess 42 that extends partially through sidewall 12. Preferably,
sidewall 12 has a slight clearance space 43 for air passage as
shown in the dotted line. However, if the bottom area of the
cylindrical wall 12 does contact flange 7 this would not be an air
tight seal and air could still pass cylindrical wall 12 for
equalizing pressure inside cap 8 with the air outside of cap 8.
The outer cap remains secured to the flange 7 by webs such as 17
and 18 until ready for use. Immediately before use the outer cap is
removed by either a twisting motion or a cocking motion. FIG. 6
shows the preferred cocking motion that tends to break the
frangible webs one at a time reducing the force required. This
makes opening slightly easier for the nurse or physician. A
twisting motion tends to fracture all of the webs at once.
After the outer cap 8 (third barrier) has been removed, the foil 24
(second barrier) is peeled back from outlet tube 22. This exposes
sleeve section 30 of the outlet tube with its tapered inner wall
surface that receives a tubular spike of an administration set.
Such tubular spike 50, shown in dotted line, punctures the end wall
diaphragm 31 (first barrier) after the spike 50 has formed a seal
with the inner flange at a top of the sleeve section 30. For ease
of molding barrier 31 it can be formed with a protrusion 51 formed
by a gate in the mold through which plastic is injected into the
mold. Protrusioon 51 can be located in a center portion of
puncturable wall 31 so as not to intefere with a pointed puncturing
section of spike 50 in dotted line shown engaging a left edge
portion of diaphragm 31 in FIG. 7. To strengthen the joint between
the diaphragm 31 and tubular sleeve 30 and prevent premature
breakage in this area is an integral annular rib that extends below
diaphragm 31.
After the spike 50 of an administration set has been connected, the
bottle is inverted and hung from its hinged hanger 5 for draining
the sterile liquid contents in the bottle through the
administration set.
In the above description the three barrier closure system has been
described relative to the outer tube 22. The additive tube 23 also
forms a three barrier closure system with the outer cap 8 being the
third barrier. With additive tube 23 a puncturable resealable
diaphragm 25 forms the first hermetic barrier, and the foil 24
sealed to the outer end of additive tube 23 forms the second
hermetic barrier. There is a sealed air chamber between diaphragm
25 and foil 24.
It has been found that this invention with the triple barrier
closure system works very well with the collapsible thermoplastic
bottle, the inner closure, and the outer cap all made of a
propyleneethylene copolymer thermoplastic. The foil 24 is a
laminate of a thermoplastic material and an aluminum foil with the
thermoplastic material fused to the dispensing outlet tube.
In the foregoing specification a specific example has been used to
describe the invention. However it is understood by those skilled
in the art that certain modifications can be made to this example
without departing from the spirit and scope of the invention.
* * * * *