U.S. patent number 3,905,368 [Application Number 05/443,011] was granted by the patent office on 1975-09-16 for pierceable access port assembly.
This patent grant is currently assigned to Cutter Laboratories, Inc.. Invention is credited to Dan Lewis, Jr., Myron R. Prouty, Raymond D. Von Alven.
United States Patent |
3,905,368 |
Lewis, Jr. , et al. |
September 16, 1975 |
**Please see images for:
( Certificate of Correction ) ** |
Pierceable access port assembly
Abstract
The pierceable access port assembly includes a container having
a mounting flange formed at one end thereof and an access port unit
having an assembly mounting flange which is hermetically sealed to
the container flange. In one embodiment, the access port unit
includes a sidewall which engages the inner surface of the neck of
the container over substantially the entire periphery thereof and
includes port means spaced inwardly from the sidewall which
terminates within the confines of the sidewall. In a second
embodiment, the access port unit extends outwardly from the
container neck and employs a unitary container closure as a
pierceable diaphragm and a double-walled flange. Both embodiments
employ an access unit mounting flange sealed to a container
mounting flange to provide a strong, reinforced flange structure
which may be firmly grasped to facilitate the insertion of a spike
or needle into the access port assembly.
Inventors: |
Lewis, Jr.; Dan (Concord,
CA), Von Alven; Raymond D. (San Raphael, CA), Prouty;
Myron R. (Oakland, CA) |
Assignee: |
Cutter Laboratories, Inc.
(Berkeley, CA)
|
Family
ID: |
23759077 |
Appl.
No.: |
05/443,011 |
Filed: |
February 15, 1974 |
Current U.S.
Class: |
604/415; 215/249;
215/253; 383/22; 128/DIG.24; 215/251; 222/212; 383/96 |
Current CPC
Class: |
A61J
1/1431 (20150501); A61J 1/18 (20130101); A61J
1/1406 (20130101); A61J 1/1487 (20150501); A61J
1/1462 (20130101); A61J 1/1468 (20150501); Y10S
128/24 (20130101) |
Current International
Class: |
A61J
1/00 (20060101); A61j 001/00 () |
Field of
Search: |
;128/272,214D,DIG.24,227
;150/.5,1 ;222/92,107,212,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Layton; Henry S.
Attorney, Agent or Firm: Gardiner, Sixbey, Bradford &
Carlson
Claims
We claim:
1. A sealed unit for storing and dispensing a sterile solution
comprising a container including wall means formed to provide a
container body and a container neck section extending from said
body, and a peripheral mounting flange formed integrally with said
wall means of said neck section and extending laterally outward
therefrom completely around the outermost end of said neck section,
and an access port assembly sealed to said mounting flange, said
access port assembly including sidewall means formed to engage the
inner surface of the neck section over substantially the entire
periphery of said assembly sidewall means, port means spaced
inwardly from said assembly sidewall means and connected thereto,
and an assembly mounting flange formed around the periphery of said
assembly sidewall means and extending laterally outward from one
end thereof, said assembly mounting flange overlying the peripheral
mounting flange of said container and being sealed thereto, said
port means including at least one port having an inner bore
extending longitudinally therethrough, said inner bore being closed
by a pierceable diaphragm, the outermost end of said container neck
section being closed by a closure means formed integrally with said
wall means of said neck section, said closure means providing a
pierceable diaphragm across the internal bore of said port when the
access port assembly is secured to the peripheral mounting flange
of said container.
2. The sealed unit of claim 1 wherein said closure means is formed
to provide the peripheral mounting flange for said container.
3. The sealed unit of claim 2 wherein said closure means includes a
flange section formed by two spaced walls forming an upper and a
lower wall for said flange section extending around said neck
section and laterally outward therefrom, the ends of said upper and
lower walls being joined outboard of said neck section, said upper
and lower walls being forced into contact beneath said access port
assembly to form a double walled peripheral mounting flange.
4. The sealed unit of claim 3 wherein the lower wall of said flange
section is formed integrally with the neck section of said
container, said closure means including a crown section extending
from the upper wall of the flange section across the outermost end
of the container neck section, said crown section being formed to
extend around and beneath said access port assembly within said
neck section.
5. The sealed unit of claim 4 wherein said container and closure
means are formed of flexible plastic material as a unitary
structure.
6. The sealed unit of claim 4 wherein said container wall means are
shaped to provide a neck section of smaller cross sectional area
than the cross sectional area of said container body, said neck
section terminating at an outer open end spaced from said body,
said outer open end being closed by said closure means.
7. A sealed unit for storing and dispensing a sterile solution
comprising a container including wall means formed to provide a
container body and a container neck section extending from said
body, and a peripheral mounting flange formed integrally with said
wall means of said neck section and extending laterally outward
therefrom completely around the outermost end of said neck section,
and an access port assembly sealed to said mounting flange, said
access port assembly including assembly sidewall means formed to
engage the inner surface of the neck section over substantially the
entire periphery of said assembly sidewall means, port means
including at least one port substantially coextensive with said
assembly sidewall means spaced inwardly from said assembly sidewall
means and integrally connected thereto, said port having an inner
bore extending longitudinally therethrough, said inner bore being
closed by a pierceable diaphram, and an assembly mounting flange
formed around the periphery of said assembly sidewall means and
extending laterally outward from one end thereof, said assembly
mounting flange overlying the peripheral mounting flange of said
container and being hermetically sealed thereto.
8. The sealed unit of claim 7 wherein said access port means is
formed to extend longitudinally through substantially the entire
extent of said neck section.
9. The sealed unit of claim 8 wherein said assembly sidewall means
is formed to engage substantially the entire inner surface of said
neck section.
10. A sealed unit for storing and dispensing a sterile solution
comprising a container including wall means formed to provide a
container body and a container neck section extending from said
body, and a peripheral mounting flange formed integrally with said
wall means of said neck section and extending laterally outward
therefrom completely around the outermost end of said neck section,
and an access port assembly sealed to said mounting flange, said
access port assembly including assembly sidewall means formed to
engage the inner surface of the neck section over substantially the
entire periphery of said assembly sidewall means, port means spaced
inwardly from said assembly sidewall means and connected thereto,
and an assembly mounting flange formed around the periphery of said
assembly sidewall means and extending laterally outward from one
end thereof, said assembly mounting flange overlying the peripheral
mounting flange of said container and being sealed thereto, said
assembly sidewall means defining an open ended assembly body
member, said access port assembly including a bottom wall connected
to said sidewall means and closing one end of said assembly body
member, said port means including at least one port extending from
said bottom wall toward the opposite end of said assembly body
member, said port having an inner bore extending longitudinally
therethrough and through said bottom wall.
11. The sealed unit of claim 10 wherein said port extends from said
bottom wall to a terminal end positioned within the confines of
said assembly body.
12. The sealed unit of claim 11 wherein said assembly sidewall
means is formed to engage substantially the entire inner surface of
said neck section whereby said access port assembly occupies
substantially the entire volume of said neck section.
13. The sealed unit of claim 12 wherein the inner bore of said port
is closed by a pierceable diaphragm positioned within said bore
intermediate and in spaced relationship to the ends thereof.
14. The sealed unit of claim 10 wherein said port means includes an
entry port and an additive port extending from said bottom wall
toward the opposite end of said assembly body member, both said
entry and additive ports terminating at a terminal end positioned
within the confines of said assembly body and including an inner
bore extending longitudinally therethrough and through said bottom
wall.
15. The sealed unit of claim 14 wherein the open end of said
assembly body member opposite to said bottom wall is closed by a
cover secured to said assembly mounting flange.
16. The sealed unit of claim 15 wherein a removable stopper of
resilient material is inserted in the bore of said additive
port.
17. The sealed unit of claim 14 wherein said entry and additive
ports are joined to said assembly sidewall means by reinforcing
ribs connected to said bottom wall and terminating between said
bottom wall and a point spaced inwardly from the terminal ends of
said entry and additive ports.
18. The sealed unit of claim 17 wherein said cover includes a tear
out section, said tear out section having a tab adapted to be
forced inwardly toward the bottom wall of said access port
assembly, said cover and assembly mounting flange each being
provided with an indicator means positioned to control the position
of said tab, alignment of said assembly mounting flange and cover
indicator means operating when said cover is secured to the
assembly mounting flange to position said tab relative to said
additive and entry ports.
19. The sealed unit of claim 14 wherein the bores of said entry and
additive ports are closed by a pierceable diaphragm.
20. The sealed unit of claim 19 wherein the pierceable diaphragm in
the bores of said additive and entry ports is positioned within
each such bore intermediate and in spaced relationship to the ends
thereof.
21. The sealed unit of claim 19 wherein the outermost end of said
container neck section is closed by a closure means formed
integrally with said wall means, said closure means providing a
pierceable diaphragm across the internal bores of said entry and
additive ports when the access port assembly is secured to the
peripheral mounting flange of said container.
22. The sealed unit of claim 21 wherein said closure means is
formed to provide the peripheral mounting flange for said
container.
23. A sealed unit for storing and dispensing a sterile solution
comprising a container including wall means formed to provide a
completely closed container body, at least one flanged mount
integrally formed on said wall means, said flanged mount including
a neck portion extending outwardly from said wall means having an
internal bore in communication with the interior of said container
and a flanged closure integral with said neck portion and closing
the outermost end thereof, said flanged closure including a lower
wall surrounding said neck portion and extending laterally outward
from the outermost end thereof, and an upperclosure wall extending
across the terminal end of said neck portion above said lower wall
and being joined to said lower wall outboard of said neck portion,
said lower and closure walls being secured together to form a
double walled flange extending outwardly from said neck portion,
and an access port sealed to said double walled flange, said access
port having a body with an access bore extending therethrough, said
body being sealed at one end to said double walled flange with the
access bore positioned above said closure wall, said closure wall
providing a pierceable diaphragm closing the lower end of said
access bore.
24. The sealed unit of claim 23 wherein two spaced flanged mounts
are provided at one end of said container body, each of said
flanged mounts having an access port sealed to the double walled
flange thereof.
25. The sealed unit of claim 24 wherein one of said access ports is
an entry port and the remaining access port is an additive port,
both of said access ports including a port mounting flange formed
at one end of said body and extending laterally outward therefrom
completely around said body, said port mounting flange being
secured to said double walled flange.
26. The sealed unit of claim 25 wherein the access bore of said
additive port is closed by a removable stopper of resilient
material inserted in the end thereof opposite to said port mounting
flange, said stopper being covered by a removable cover secured to
the body of said access port.
27. The sealed unit of claim 26 wherein the access bore of said
entry port is closed by a closure cap having cap sidewall means
which enclose the sides of the body of said entry port and a cap
endwall which extends from said cap sidewall means across the end
of said body opposite to said port mounting flange, the end of said
capsidewall means opposite said cap endwall including an outwardly
extending cap flange extending around said cap sidewall means, said
cap flange being sealed to the port mounting flange for said entry
port.
28. An access port assembly for installation within the neck of a
container for storing and dispensing a sterile solution comprising
a body member having a sidewall means defining an open end of said
body member, a bottom wall extending from the end of said sidewall
means opposite said body member open end to close one end of said
body member, and at least one access port extending from said
bottom wall in spaced relationship to said sidewall means and
terminating at a terminal end adjacent to the open end of said body
member but positioned within the confines of said sidewall
means.
29. The access port assembly of claim 28 wherein an entry port and
an additive port extend from said bottom wall toward the open end
of said body member in spaced relationship to one another and to
said sidewall means, both said entry and additive ports terminating
at a terminal end positioned within the confines of said sidewall
means and including an inner bore extending longitudinally
therethrough and through said bottom wall.
30. The access port assembly of claim 29 wherein said body member
is a unitary member including a first reinforcing rib extending
between said entry and additive ports and a plurality of
reinforcing ribs extending between said sidewall means and said
additive and entry ports respectively.
31. The access port assembly of claim 29 wherein the access bore of
said entry port is closed by a pierceable diaphragm positioned
intermediate the ends thereof.
32. The access port assembly of claim 29 which includes a mounting
flange extending laterally and outwardly from said sidewall means
about the periphery of the open end of said body member.
33. A sealed unit for storing and dispensing a sterile solution
comprising a container including wall means formed to provide a
container body and at least one open ended container neck section
extending from said body, and a peripheral container mounting
flange formed integrally with the wall means of said neck section
and extending annularly about the open end of said neck section and
laterally outward therefrom, and an access port sealed to said
container mounting flange and extending outwardly therefrom away
from said neck section, said access port having a body with an
access bore extending longitudinally therethrough and an integral
bottom wall extending one end of said body to close said bore, said
bottom wall extending laterally outward beyond said body around one
end thereof to form a port mounting flange, said port mounting
flange being hermetically sealed to said container mounting flange.
Description
BACKGROUND OF THE INVENTION
For effective safe storage and use of parenteral fluids and similar
sterile solutions, it is necessary that such fluids be stored in
sterile, tamper proof containers provided with means to facilitate
withdrawal of the fluid without a substantial sacrifice of
sterility. Some containers or bags are formed of flexible plastic
in such a manner as to enclose parenteral fluid or other sterile
fluid. The container is later entered through a sealed port
structure in order to dispense measured amounts of the contents
therefrom. As the liquid contents from such flexible sealed plastic
containers are dispensed, the container collapses, and therefore no
venting of the container with air which might carry contaminants is
required. Initially, it was necessary to provide the sealed bag
containers with entry or exit ports constructed so that an entry
spike or needle could be inserted through the port and retained in
tight sealed relationship therewith. Often the port consisted of a
tubular needle supporting structure secured at an end or in some
cases on a wall of the bag by a flange or similar structural
element. In some instances the portion of the bad enclosed by the
tubular element served as a pierceable diaphragm. A resilient plug
would then be fitted into the tubular element to hold the needle
inserted through the plug in the side of the bag. Bag-like sealed
containers provided with outlet fittings of this type are disclosed
in U.S. Pat. Nos. 2,838,046 to Butler and 3,368,560 to Gewecke.
Some previously developed plastic bag containers have been formed
of two plastic sheets sealed together with a plastic tube sealed
between the two sheets at one end to provide a narrow neck portion.
One known flexible bag container of this type includes a rather
short pierceable access port assembly which is inserted into the
open end of the longer neck portion of the bag. This particular
port assembly is tubular in configuration and has outwardly
extending ribs which project from the tubular walls thereof and
engage the inner surface of the neck portion. It also has an
annular flange which is sealed to a flange on the outer end of the
neck portion. The outer end of the access port assembly is closed
by a cover member which is sealed to the annular flange of the
access port assembly. The central portion of such cover is provided
with a frangible web connected to a projecting tear tab, so that
the central portion of the cover may be opened by operating the
tear tab. A spike is then inserted through this opening into the
tubular body of the access port assembly until the spike pierces a
diaphragm at the bottom of the tubular portion thereof to gain
entry to the contents of the bag. Although the rib structure of the
port assembly does provide some support for the neck portion so
that the neck may be more firmly grasped during the insertion of
the spike, these ribs have a disadvantage in that they define small
compartments or dead spaces between the surface of the neck portion
and the surface of the tubular member of the access port assembly.
It is possible for additive solutions introduced into the container
through such a port to be trapped in more or less undiluted form in
these dead spaces so that not all the additive is delivered to the
patient.
Generally, tubular access port assemblies for insertion in the neck
of a flexible bag include only a single entry port, and after an
entry spike has been installed therein, it is necessary to have
another fitting adjacent to the first port or on a side of the
container if additives are to be supplied to the solution within
the container. Also, conventional access port assemblies occupy
only a portion of the space in the neck of the bag-like container,
so that it is possible for additive solutions introduced through
the access port or an adjacent additive port to layer in the neck
area of the container without becoming diluted completely by the
fluid contained in the body of the container. If a concentrated
additive solution is not uniformly mixed with a parenteral solution
in the container, an essentially undiluted portion of the additive
might be administered to a patient. This could be very harmful if
the additive were a potent, highly reactive drug.
Finally, the diaphragm in known access port assemblies is generally
positioned at the bottom of the tubular portion of the port a spike
has to be inserted completely through the port before the diaphragm
is penetrated. This means that the tapered terminal portion of the
spike may be in the area of the ruptured diaphragm, and there is a
tendency for the stretched resilient material of the diaphragm to
exert a backward force on the tapered portion of the spike tending
to dislodge the spike from the diaphragm.
Recently, interest has developed in the use of blow molded flexible
containers as containers for sterile solutions. Such containers may
be blow molded to provide a neck end which is sealed, and before
the sealing of the neck end, sterile solution may be introduced
into the container. In some instances, integral closed end access
ports have been formed on the neck portion of such containers
during the molding operation as is proposed by U.S. Pat. Nos.
3,589,422 to Bellamy and 3,746,001 to Ralston. Also in some
instances, containers may be blow molded to provide a large open
end or neck, and in these cases, integral access ports cannot be
formed, and additional means must be provided for closing the
container.
It is a primary object of the present invention to provide a novel
and improved pierceable access port assembly for a flexible sterile
solution container which may be effectively and easily secured to
the container, and which operates to facilitate the introduction of
an additive into the container or the withdrawal of fluid from the
container without danger of contamination.
Another object of the present invention is to provide a novel and
improved pierceable access port assembly for a flexible sterile
solution container which may be readily sealed to the neck portion
of conventional blow molded flexible containers to hermetically
seal the container.
A further object of the present invention is to provide a novel and
improved pierceable access port assembly for a flexible sterile
solution container which constitues a unitary structure with access
and dispensing ports recessed within the container neck and adapted
to fill substantially the entire volume of the container neck to
insure direct injection of an additive into a solution contained in
the body of the container.
Another object of the present invention is to provide a novel and
improved pierceable access port assembly for a flexible sterile
solution container which includes an access port closed by a
pierceable diaphragm which is positioned to enhance the retention
of an inserted spike.
A further object of the present invention is to provide a novel and
improved pierceable access port assembly particularly adapted for
attachment to a dome shaped neck closure for an enclosed blow
molded container.
Another object of the present invention is to provide a novel
enclosed blow molded flexible sterile solution container having
attached additive and dispensing port means secured to a dome
shaped neck closure member formed integrally on the container
during the blow molding process.
Yet another object of the present invention is to provide a novel
enclosed blow molded flexible solution container with a pierceable
access port assembly having flange means for grasping to facilitate
the insertion of a spike member.
A still further object of the present invention is to provide a
novel enclosed blow molded flexible sterile solution container
wherein an integral portion of the container is employed as a
mounting flange for a pierceable access port assembly.
These and other objects of the present invention will become
readily apparent upon consideration of the following specification
and claims taken in conjunction with the accompanying drawings in
which:
FIG. 1 is a partially sectioned view illustrating a conventional
open neck blow molded flexible container for sterile solutions;
FIG. 2 is a sectional view of a closed neck embodiment adapted to
replace the open neck of the blow molded container of FIG. 1;
FIG. 3 is a sectional view of a second embodiment of a closed neck
adapted to replace the open neck of the blow molded container of
FIG. 1;
FIG. 4 is a sectional view of the pierceable access port assembly
of the present invention secured to the neck of the container of
FIG. 1;
FIG. 5 is a plan view of the pierceable across port assembly of
FIG. 4 with the cover section intact;
FIG. 6 is a plan view of the pierceable access port assembly of
FIG. 4 with a frangible portion of the cover removed;
FIG. 7 is a sectional view of a second embodiment of the pierceable
access port assembly of the present invention secured within the
container neck of FIG. 2;
FIG. 8 is a sectional view of a third embodiment of the pierceable
access port assembly of the present invention secured to the
container neck of FIG. 3; and
FIG. 9 is a sectional view of a fourth embodiment of the pierceable
access port assembly of the present invention.
Referring now to the drawings, FIG. 1 discloses a flexible plastic
container 10 adapted for use in storing and dispensing sterile
solutions such as parenteral solutions, blood plasma, blood, etc.
The container 10 constitutes a collapsible container having a
closed body member 12 formed by a blow molding process to any shape
employed for such containers. During the blow molding process, the
body member is provided with a large open neck, and this body
member tapers to a neck portion 14 which terminates at a relatively
large open end 16. Generally, a hanger portion 18 will be formed at
the end of the container opposite the neck 14. The container 10 is
formed of plastic material which is compatible with the particular
sterile solution to be contained. For example, with parenteral
solutions, the container may be formed of polyvinyl chloride,
polyalkylenes such as polyethylene, polypropylene or copolymers of
ethylene and propylene.
During the formation of a blow molded container 10, it is often
desirable to completely close the container and omit the open end
16 of FIG. 1. To accomplish this, the container body and neck are
first formed, the sterile solution is introduced into the
container, and then the neck is closed by sealing. One form of
closure for the neck 14 is illustrated in FIG. 2 wherein the
closure indicated generally at 20 for the container neck includes a
flange section 22 formed integrally with the wall of the container
neck and a side wall 24 which tapers upwardly from the flange
section to a crown closure wall 26.
In FIG. 3, a second closure embodiment for the neck 14 of the
container 10 is disclosed wherein two closed button-like
projections 28 and 30 are provided on the closed end during the
blow molding process. Each of these button-like projections
includes a neck portion 32 extending upwardly from a top closure
wall 34 that extends across the terminal end of the neck portion
14. The neck portions 32 are each formed with an outwardly
extending flange section 35 which extends upwardly to a top closure
wall 36.
Referring now to FIGS. 4-6, the pierceable access port assembly of
the present invention indicated generally at 38 is illustrated in
position within the open neck 14 of the container 10 of FIG. 1. The
pierceable access port assembly includes a substantially tubular
side wall 40 which terminates at a bottom wall 42 formed integrally
therewith. The opposite end of the tubular side wall includes an
outwardly extending flange 44 which is formed annularly to define
an opening 46.
Integrally formed with the bottom wall 42 and extending upwardly
therefrom are two spaced, open-ended ports 48 and 50 which are
substantially tubular in structure. These ports define inner bores
or channels 52 and 54 respectively which extend between the open
ends thereof, each such bore being completely closed by a diaphragm
or web 56 positioned substantially at the mid-point of each port
and extending between the side walls thereof.
The upper open ends 58 and 60 of each of the ports 48 and 50
terminate at a position spaced below the uppermost surface 62 of
the flange 44. A plurality of annular, spaced inwardly projecting
beaded projections 66 may be formed on the inner wall of each of
the ports 48 and 50 adjacent the open ends 58 and 60. These
projections are formed in the portions of the wall above the
diaphragms 56. They provide greater interference fit for retention
of an inserted spike or stopper.
A reinforcing rib 68 extends between the ports 48 and 50, and
reinforcing ribs 72, 74 and 76 extend between the port 48 and the
side wall 40, while reinforcing ribs 78, 80 and 82 extend between
the port 50 and the side wall 40. Although each of these
reinforcing ribs extends upwardly from the bottom wall 42, it
should be noted that the upper surfaces thereof terminate well
below the upper terminal ends 58 and 60 of the ports 48 and 50.
The opening 46 in the pierceable access port assembly 38 is closed
by a suitable cover 84 which is secured to the upper surface 62 of
the flange 44. This cover may include a frangible removable
portion, which, when removed, exposes the upper ends 58 and 60 of
the ports 48 and 50 as illustrated in FIG. 6. Any known frangible
cover suitable to perform this purpose may be employed, such as
covers with vertical pull tabs, tear strips, etc. To prevent
accidental opening of the cover and contamination of the portions
of the access port assembly enclosed therein, it is preferable that
no outwardly projecting tear tabs which may be accidentally caught
or snagged be included in the cover structure. Instead, the cover
of FIG. 5 is preferable having score lines 86 and 88 which define
the tear away portion. These score lines also define an enlarged
push-in section 90 which, when pushed inwardly, is adapted to tear
along the acore line and to permit removal of the tear away portion
of the cover. This push-in section 90 is positioned above an open
space which is defined by the ribs 68, 76 and 82 and the bottom
wall 42. To assure that the push-in section is properly positioned,
both the cover 84 and the flange 44 are provided with alignment
indicators 92 and 94 respectively. These alignment indicators
merely constitute outwardly projecting tabs, and when the tab 92 of
the cover 84 is aligned with the tab 94 on the flange 44, the
push-in section 90 is properly positioned.
The upper end of the one of the ports 48 or 50 above the diaphragm
56 is closed by a rubber stopper 96 which substantially fills the
space between the upper end of the port and the lower surface of
the cover 84. The stopper is designed to receive the needle of an
additive container when an additive is injected into the body 12 of
the sterile solution container.
In the formation of the sterile container 10 with the pierceable
access port assembly 38, the container is first blow molded as
illustrated in FIG. 1, washed and the desired solution introduced
therein. Then a pierceable access port assembly 38 is inserted into
the neck of the container and, as will be noted in FIG. 4, the
outermost terminal portion of the container neck 14 is formed
outwardly to provide a support flange 102 beneath the flange 44.
Then the flanges 44 and 102 and the cover 84 are all hermetically
sealed together in the flange area by a suitable sealing method
such as sealing by radio frequency energy, ultrasonic welding, or
solvent sealing. The sealing of the three parts may occur
simultaneously, or the flange 102 of neck 14 may first be sealed to
the flange 44 and subsequently the cover 84 may be sealed to the
flange 44. The sealed container and its contents are then
sterilized.
The sealed, three-layered flange portion offers a means for firm
grasping of the port structure so that a spike of an administration
set may more readily be inserted through the entry port.
The pierceable access port assembly 38 is preferably a unitary
molded assembly which is preferably formed of the same material
employed to form the container 10. This unitary assembly provides
both an entry port and an additive port without requiring the
provision of two separate fittings for the container. It is
significant to note the tubular wall 40 of the access port assembly
is designed to fit tightly against the inner surface of the neck
portion 14 for the container and leaves no dead spaces where
additives might be trapped. Also of extreme importance is the fact
that the tubular wall 40 contacts the inner wall of the neck
portion 14 over substantially the entire extent thereof, and the
access port assembly occupies substantially the complete volume of
the neck portion of the container. Therefore, no dead spaces are
present in the container neck where sn additive introduced through
the stopper 96 could concentrate, and instead, the additive will be
directly introduced into the body 12 of the container and be
readily dispersed.
When entry spikes, which are generally fairly short in length and
tapered near the tip portion, are introduced into the port 48, the
tip of the spike punctures the diaphragm 56 and projections 66 aid
in firmly sealing the spike within the port. It is advantageous to
position the diaphragm at least midway up the port, for otherwise,
the diaphragm tends to dislodge the spike after puncture of the
diaphragm occurs. If just the tapered tip portion of the spike is
in the area of the ruptured diaphragm, there is a tendency for the
resilient material of the diaphragm to push upwardly on the spike,
thus resulting in dislodgement of the spike.
The stopper 96 is employed where an additive solution is added
through a needle, but the stopper would not be required for an
additive package which utilizes a spike. Where a needle is
employed, it is not necessary to have both the stopper 96 and the
diaphragm 56 present in the port 50, but the diaphragm does assure
that the solution in the container will not be discharged should
the stopper become dislodged.
The plurality of ribs between the ports and the side wall 40 of the
access port assembly stabilizes the individual ports relative to
each other and to the neck of the container. These ribs help
rigidify the neck portion of the container so that the neck can be
more firmly held by an operator while manipulating a spike for
insertion or while introducing an additive solution into the
container. Since the ports 48 and 50 are recessed within the
container and protected bythe outer wall thereof, these ports are
not subjected to impacts which might occur with projecting ports
and therefore damage to the ports and possible contamination during
transportation and storage is minimized.
Referring now to FIG. 7, there is illustrated a second embodiment
of the pierceable access port assembly indicated generally at 104
which includes no internal diaphragms but which incorporates the
closure 20 of the container of FIG. 2 as a diaphragm and mounting
unit. The pierceable access port assembly 104 incorporates a
structure which is substantially identical to the structure
included above the diaphragms 56 of the pierceable access port
assembly 38, and therefore the reference numerals of FIGS. 4-6 will
be employed for identical components illustrated in FIG. 7.
The pierceable access port assembly 104 is preferably designed to
completely fill the interior of the neck portion 14 for the
container 10, although in some instances, only the upper portion of
the neck would be occupied thereby. The tubular siide wall 40 which
engages the inner surface of the container neck terminates at the
bottom wall 42 from which the ports 48 and 50 project. It will be
noted, however, that the ports 48 and 50 contain no internal
diaphragm, but instead employ the crown portion 26 of the container
closure for this purpose. Thus, in providing the container of FIG.
2 with the pierceable access port assembly 104, the container is
formed then the sterile contents are injected therein, and
subsequently the closure 20 is formed to seal the container.
Initially, the closure 20 is in the dotted line position of FIG. 7,
and it will be noted that the side wall 24 and crown closure wall
26 thereof are formed to approximate the configuration of the side
wall 40 and bottom wall 42 of the pierceable access port assembly.
Also, the flange portion 22 of the closure 20 is formed to
approximate the width of the flange 44.
Once the enclosed container of FIG. 2 is formed and filled with
sterile solution, the pierceable access port assembly 104 is
mounted thereon by first depressing the cover 20 into the neck 14
of the container as illustrated. This causes an outer side wall 106
of the flange portion 22 to be folded down tightly against a bottom
wall 108 of the flange portion to form a double walled mounting
flange 110 extending annularly about the container opening. This
double walled annular flange is then sealed to the flange 44 of the
pierceable access port assembly 104 in the manner previously
described in connection with FIGS. 4-6. When sealed, by radio
frequency energy for example, the bottom surface of flange 44 fuses
to the top surface of flange 110 and at the same time the abutting
surfaces of the walls 106 and 108 also fuse together. The coveer 84
may then be sealed to the flange 44.
The insertion of the pierceable access port assembly 104 into the
neck 14 of the container 10 after the closure 20 has been inserted
therein causes the side wall 24 of the closure to seal tightly
against the surface of the neck portion 14 and provide a double
wall for the neck portion. The side wall 24 now becomes the inner
wall of the neck portion against which the side wall 40 of the
access port assembly engages, while the crown portion 26 of the
closure extends along the bottom wall 42. Thus, the crown portion
26 provides a pierceable diaphragm for both the port 48 and the
port 50 which may then be subsequently pierced by a spike or needle
inserted into one of the ports.
The embodiment of the pierceable access port assembly disclosed by
FIG. 8 is adapted for the closed container of FIG. 3, and separate
ports are sealed to double walled flanges provided by the
button-like projections 28 and 30. Referring to FIG. 8, an additive
port 112, is secured to the button-like projection 28 of the
container 10. This additive port is of substantially open ended
tubular configuration to define an inner bore 114, and the port
includes a side wall 116, the lower end of which terminates at an
outwardly projecting annular flange 118. The side wall 116 is
thickened at the end thereof opposite the flange 118 to provide an
annular cap retaining lip 120. The inner surfaces of the additive
port adjacent to the lip 120 may be provided with annular beaded
projections 122 to aid in retaining a stopper 124 which is inserted
into the port.
Stopper 124 operates in combination with a cap structure 130 which
is contained by the lip 120 to seal the additive port 112. The cap
structure 130 includes a stopper retainer 132, a resilient disc
134, and a tear offcap 136. The tear off cap includes a tear away
portion 138 which overlies the disc 134 and, with the remainder of
the tear off cap, forms a relatively solid metallic backing for the
disc. The stopper retainer 132 and the tear off cap 136 are engaged
beneath the lip 120 so that the tear off cap imparts a compressive
force to the disc 134.
In addition to the additive port 112, an entry port 140 is provided
on the container 10 and is secured to the buttonlike projection 30
thereof. Entry port 140 is also of open ended tubular configuration
and includes a substantially tubular side wall 142 which defines an
innerbore 144. Side wall 142 terminates at one end in an outwardly
projecting annular flange 146, and the inner surface of the side
wall at the end opposite the flange 146 may be provided with
annular beaded projections 148. These projections are adapted to
seal and retain a spike inserted in the port 140 in the manner
previously described in connection with the pierceable port
assemblies 38 and 104.
The end of the entry port 140 adjacent the bead like projections
148 is closed by a protector member 150 formed of polyvinyl
chloride or other suitable plastic or metal materials. The
protector 150 includes a tubular side wall 152 adapted to fit
tightly about the side wall 142 of the entry port, one end of the
side wall 152 terminating in an outwardly extending annular flange
154 which is adapted to engage and overlie the flange 146. The end
of the protector opposite the flange 154 is closed by a top closure
wall 156 which is provided with an integral support projection 158
extending in the direction of the flange 154. The projection 158 is
adapted to extend into the bore 144 when the protector is in
position over the entry port 140 as disclosed in FIG. 8.
An annular groove 160 is formed in the inner surface of the side
wall 152 to reduce the thickness of the side wall and provide a
thin frangible area 162. A tab 164 is formed integrally with the
side wall 152 and projects upwardly above the top wall 156. To gain
access to the entry port 140, the tab 164 is pulled to cause the
protector 140 to rupture at the thin frangible section 162 so that
the upper portion of the protector may be removed.
The additive port 112 and the entry port 140 are attached to the
container 10 in much the same manner as was the pierceable entry
port assembly 104 of FIG. 7. After the container of FIG. 3 is
formed, filled, and closed, the upper surface 36 of the button-like
projections 28 and 30 is compressed downwardly causing flange
sections 35 to flatten so that a portion of the upper surface 36
and a lower annular wall section 166 form an annular, double walled
flange 168 at the top of each of the button-like projections. The
flanges 118 and 146 of the ports 112 and 140 are sealed thereto in
the manner previously described. This sealed, multi-layered flange
portion allows one to grasp the entry or additive port structure
firmly so as to facilitate the insertion of a spike or needle. The
flange 154 of the protector 150 is sealed to the flange 146, and
this may occur separately or as a single operation involved in
sealing the access port to the flange 168.
It will be noted that the top walls 36 of the button-like
projections 28 and 30 operate as a pierceable diaphragm for the
additive port 112 and the entry port 140.
FIG. 9 discloses a modification of the pierceable access port
assembly of FIG. 8 which is adapted for use on open neck containers
of the type shown by FIG. 1 or containers similar to that shown by
FIG. 3 without the button-like closure projections 28 and 30. The
structure shown in FIG. 9 is substantially identical to the entry
port 140 of FIG. 8, the only modification being the provision of a
bottom wall 170 contiguous with the flange 146. This bottom wall
extends across the open end of the container 10 and provides a
pierceable diaphragm and closure for the container. The flange 146
is sealed to a flange 172 formed about the open end of the
container in the manner previously described. Obviously the
structure of FIG. 9 could also be used for the additive port 112 of
FIG. 8.
It will be readily apparent to those skilled in the art that the
present invention provides improved pierceable entry port
assemblies for blow molded or otherwise formed plastic containers
which may be easily formed and used with no danger of container
content contamination. The flange structure at the bottom of each
assembly which cooperates with an annular flange integrally formed
at the top of the container permits a very effective hermetic seal
to be achieved through the use of radio frequency, ultrasonic, or
solvent sealing techniques. Not only does the cooperating annular
flange formed integrally with the container neck provide a strong
mounting flange for the port assembly, but it also is designed to
simplify the sealing process. It is quite simple to insert
conventional sealing apparatus over the various port assembly
embodiments to engage the outwardly projecting flange structure and
achieve the desired hermetic seal between the container and the
pierceable port assembly. Therefore, the manufacturing process
involved is greatly simplified.
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