Title:
PIERCEABLE ACCESS PORT FOR PARENTERAL SOLUTION CONTAINERS
United States Patent 3746001
Abstract:
A picerceable access port for parenteral solution containers, including a flexible plastic tube communicating at one end with the interior of the container and closed at its other end to seal the container. A gripping sleeve is positioned about the flexible plastic tube so that the free end of the plastic tube is positioned within the bore of the sleeve. By this arrangement, the free end of the flexible tube defines a puncturable diaphragm within the gripping sleeve accessible to a piercing spike passing through the sleeve to gain access to the container.
US Patent References:
Molded container having discharge spout
Meissner - September 1967 - 3339812
Collection system for body fluids
Folkman et al. - December 1967 - 3357429
Molded container having discharge spout
Meissner - September 1967 - 3339812
Collection system for body fluids
Folkman et al. - December 1967 - 3357429
Application Number:
05/190875
Publication Date:
07/17/1973
Filing Date:
10/20/1971
View Patent Images:
Export Citation:
Assignee:
Baxter Laboratories, Inc. (Morton Grove, IL)
Primary Class:
Other Classes:
D24/118, 383/22, 215/247, 383/96
International Classes:
A61J1/00; A61J1/05; A61M5/14
Field of Search:
128/214D,214,272 150/8 215/42
Primary Examiner:
Laudenslager, Lucie H.
Claims:
That which is claimed is
1. In a parenteral solution container having a container wall, a pierceable access wall which comprises a flexible plastic tube formed as an integral part of said container wall, said tube communicating at one end with the interior of said container and closed at its outer end to seal said container, and an open ended, tubular gripping sleeve positioned about said flexible plastic tube, with said outer end positioned in the bore of said sleeve to define a puncturable diaphragm accessible to a piercing spike which is passed through said sleeve to gain access to said container, said gripping sleeve having a bore of uniform transverse dimension outwardly from said outer tube end, said gripping sleeve being positioned so that a portion of said flexible plastic tube adjacent said container is not within said sleeve, to provide spacing between said sleeve and the container.
2. The parenteral solution container of claim 1 in which the tubular gripping sleeve has an outer portion of greater wall thickness than its inner portion, to cooperate with said tube to provide a bore of uniform diameter through said access port.
3. The parenteral solution container of claim 2 in which said sleeve is made of semirigid plastic.
4. The parenteral solution container of claim 3 which comprises a blow-molded, collapsible plastic container.
5. The parenteral solution container of claim 1 which has a plurality of said pierceable access ports.
1. In a parenteral solution container having a container wall, a pierceable access wall which comprises a flexible plastic tube formed as an integral part of said container wall, said tube communicating at one end with the interior of said container and closed at its outer end to seal said container, and an open ended, tubular gripping sleeve positioned about said flexible plastic tube, with said outer end positioned in the bore of said sleeve to define a puncturable diaphragm accessible to a piercing spike which is passed through said sleeve to gain access to said container, said gripping sleeve having a bore of uniform transverse dimension outwardly from said outer tube end, said gripping sleeve being positioned so that a portion of said flexible plastic tube adjacent said container is not within said sleeve, to provide spacing between said sleeve and the container.
2. The parenteral solution container of claim 1 in which the tubular gripping sleeve has an outer portion of greater wall thickness than its inner portion, to cooperate with said tube to provide a bore of uniform diameter through said access port.
3. The parenteral solution container of claim 2 in which said sleeve is made of semirigid plastic.
4. The parenteral solution container of claim 3 which comprises a blow-molded, collapsible plastic container.
5. The parenteral solution container of claim 1 which has a plurality of said pierceable access ports.
Description:
BACKGROUND OF THE INVENTION
Parenteral solution containers must be constructed to provide absolute sterility to their contents until they are opened. Also, it is necessary that the means for access to the contents of the parenteral solution container allow such access to take place under absolutely sterile conditions.
In the conventional glass bottles, elaborate seals made of several separate parts are used, such as are shown in U.S. Pat. Nos. 2,969,158 and 3,313,439. In plastic blood bags, a large variety of complex seals are also used, such as that shown in U.S. Pat. Nos. 3,509,879 and 3,030,955. In these structures, it is contemplated that the bag material itself serves as a sealing diaphragm, while a needle-supporting structure is attached to the bag, for example, by means of a saddle-like structure or a flange extending over and glued to the bag. The saddle or flange must have sufficient surface area to provide good adhesion in order to prevent the accidental removal of the needle-supporting structure.
In accordance with this invention, a simpler and more convenient structure for access to a parenteral solution container is provided. This structure is particularly useful in conjunction with extruded parenteral solution containers, similar to those disclosed in U.S. Pat. No. 3,589,422, which can be blow-molded and simultaneously filled with the solution, for example, in accordance with the teachings of U.S. Pat. No. 3,325,860.
By the term "parenteral solution container" it is generally contemplated to include containers for blood as well as for all solutions injectable for medical purposes or the like.
DESCRIPTION OF THE INVENTION
In accordance with this invention, a parenteral solution container is provided having a pierceable access port, which comprises a flexible plastic tube, formed as an integral part of the container wall, communicating at one end with the interior of the container and closed at its other end to seal said container. Such plastic tubes can be simultaneously molded as part of the parenteral solution container during the blow-molding operation by appropriate design of the mold. A tubular gripping sleeve is positioned about each flexible plastic tube with the free end of the flexible tube positioned within the bore of the sleeve. Thus, the free end of the flexible tube defines a puncturable diaphragm which is accessible to a piercing spike which is passed through the sleeve to gain access to the container. Outwardly from the free tube end, the sleeve has a bore of uniform transverse dimension, which provides sealing around a piercing spike of appropriate size, to sealingly fit within the bore of the sleeve. An area of most effective sealing is provided as the spike passes through the free end of the flexible tube, forcing the flexible tube material against the walls of the bore of the sleeve in a pressure sealing relation.
Referring to the drawings, FIG. 1 shows an elevational view of a typical parenteral solution container of this invention having a pair of pierceable access ports at the bottom of the container in position of use.
FIG. 2 shows the same parenteral solution container rotated 90° about its vertical axis.
FIG. 3 is a magnified fragmentary view of the container of FIG. 1 shown partly in vertical section, with a piercing spike in connection with an access port.
Referring to the drawings, flexible plastic container or bag 10 is illustrated, being typically manufactured by a blow-molding operation from a tubular parison of polyvinyl chloride, polypropylene homopolymers or copolymers, or another appropriate plastic material. Bag 10 is collapsible as parenteral solution is drained from the bag, so that it becomes unnecessary to vent it in order to obtain its contents.
Bag 10 has V-shaped grooves 12, 14 running along its length, which tend to assist in the flat collapsing of the bag. Integral hanger 16 is simultaneously made from a portion of the parison as the rest of bag 10 is fabricated.
At the other end from hanger 16, bag 10 defines head 18, which in turn carries a pair of pierceable access ports 20, 21. One access port 21 is sealed with a latex plug 22 as an injection site, while the other access port is sealed with a tubular cover of vinyl 24 having a removal tab, to maintain sterility. Both plug 22 and vinyl removal tab 24 are conventionally used at the present time in the commercially available VIAFLEX TM solution container marketed by Baxter Laboratories, Inc..
In accordance with this invention, each access port 20, 21 comprises a flexible plastic tube 26, which is integrally fabricated with the remainder of container 10 and which communicates with the interior thereof. The outer or free end 28 of tube 26 is closed to seal the container. Gripping sleeve 30, typically made out of a semirigid plastic to provide a site for firm gripping with the fingers, is positioned about tube 26, with free tube end 28 being typically positioned with the bore of sleeve 30. Sleeve 30 is usually solvent sealed or otherwise firmly attached to tube 26. Sleeve 30 is easily attached to bag 10 with less danger of separation than in the prior art structures.
Sleeve 30 is shown to have an outer thickened portion 31 to compensate for the wall thickness of tube 26 in order to provide a bore of generally uniform diameter through the access port for improved sealing. Alternatively, sleeve 30 can carry a short, inner sleeve to reduce its bore diameter at its outer portion.
By this arrangement, end 28 of tube 26 defines a puncturable diaphragm accessible to a piercing spike 32, which is inserted in the bore of gripping sleeve 30 after removing cover 24 and forced through end 28 to gain access to the contents of container 10. Simultaneously, the broken end 28 is firmly pressed by spike 32 against the inner wall of tube 26 to provide an added pressure seal, to assure that parenteral solution does not leak out of the container around the spike. Additionally, tube 26 and sleeve 30 provides sealing against the outside of spike 32.
Hence, aseptic, nonleaking access to container 10 is provided by the pierceable access port of this invention.
Some spacing is typically provided between sleeve 30 and head 18 to provide added flexibility to access ports 20, 21 for ease of gripping and piercing.
The second access port 21 can be used for the addition of supplemental medication by a needle through latex plug 22 and the corresponding tube end 28, if desired.
The above has been offered for purposes of illustration only, and is not to be construed as limiting the invention of this application as defined by the claims.
Parenteral solution containers must be constructed to provide absolute sterility to their contents until they are opened. Also, it is necessary that the means for access to the contents of the parenteral solution container allow such access to take place under absolutely sterile conditions.
In the conventional glass bottles, elaborate seals made of several separate parts are used, such as are shown in U.S. Pat. Nos. 2,969,158 and 3,313,439. In plastic blood bags, a large variety of complex seals are also used, such as that shown in U.S. Pat. Nos. 3,509,879 and 3,030,955. In these structures, it is contemplated that the bag material itself serves as a sealing diaphragm, while a needle-supporting structure is attached to the bag, for example, by means of a saddle-like structure or a flange extending over and glued to the bag. The saddle or flange must have sufficient surface area to provide good adhesion in order to prevent the accidental removal of the needle-supporting structure.
In accordance with this invention, a simpler and more convenient structure for access to a parenteral solution container is provided. This structure is particularly useful in conjunction with extruded parenteral solution containers, similar to those disclosed in U.S. Pat. No. 3,589,422, which can be blow-molded and simultaneously filled with the solution, for example, in accordance with the teachings of U.S. Pat. No. 3,325,860.
By the term "parenteral solution container" it is generally contemplated to include containers for blood as well as for all solutions injectable for medical purposes or the like.
DESCRIPTION OF THE INVENTION
In accordance with this invention, a parenteral solution container is provided having a pierceable access port, which comprises a flexible plastic tube, formed as an integral part of the container wall, communicating at one end with the interior of the container and closed at its other end to seal said container. Such plastic tubes can be simultaneously molded as part of the parenteral solution container during the blow-molding operation by appropriate design of the mold. A tubular gripping sleeve is positioned about each flexible plastic tube with the free end of the flexible tube positioned within the bore of the sleeve. Thus, the free end of the flexible tube defines a puncturable diaphragm which is accessible to a piercing spike which is passed through the sleeve to gain access to the container. Outwardly from the free tube end, the sleeve has a bore of uniform transverse dimension, which provides sealing around a piercing spike of appropriate size, to sealingly fit within the bore of the sleeve. An area of most effective sealing is provided as the spike passes through the free end of the flexible tube, forcing the flexible tube material against the walls of the bore of the sleeve in a pressure sealing relation.
Referring to the drawings, FIG. 1 shows an elevational view of a typical parenteral solution container of this invention having a pair of pierceable access ports at the bottom of the container in position of use.
FIG. 2 shows the same parenteral solution container rotated 90° about its vertical axis.
FIG. 3 is a magnified fragmentary view of the container of FIG. 1 shown partly in vertical section, with a piercing spike in connection with an access port.
Referring to the drawings, flexible plastic container or bag 10 is illustrated, being typically manufactured by a blow-molding operation from a tubular parison of polyvinyl chloride, polypropylene homopolymers or copolymers, or another appropriate plastic material. Bag 10 is collapsible as parenteral solution is drained from the bag, so that it becomes unnecessary to vent it in order to obtain its contents.
Bag 10 has V-shaped grooves 12, 14 running along its length, which tend to assist in the flat collapsing of the bag. Integral hanger 16 is simultaneously made from a portion of the parison as the rest of bag 10 is fabricated.
At the other end from hanger 16, bag 10 defines head 18, which in turn carries a pair of pierceable access ports 20, 21. One access port 21 is sealed with a latex plug 22 as an injection site, while the other access port is sealed with a tubular cover of vinyl 24 having a removal tab, to maintain sterility. Both plug 22 and vinyl removal tab 24 are conventionally used at the present time in the commercially available VIAFLEX TM solution container marketed by Baxter Laboratories, Inc..
In accordance with this invention, each access port 20, 21 comprises a flexible plastic tube 26, which is integrally fabricated with the remainder of container 10 and which communicates with the interior thereof. The outer or free end 28 of tube 26 is closed to seal the container. Gripping sleeve 30, typically made out of a semirigid plastic to provide a site for firm gripping with the fingers, is positioned about tube 26, with free tube end 28 being typically positioned with the bore of sleeve 30. Sleeve 30 is usually solvent sealed or otherwise firmly attached to tube 26. Sleeve 30 is easily attached to bag 10 with less danger of separation than in the prior art structures.
Sleeve 30 is shown to have an outer thickened portion 31 to compensate for the wall thickness of tube 26 in order to provide a bore of generally uniform diameter through the access port for improved sealing. Alternatively, sleeve 30 can carry a short, inner sleeve to reduce its bore diameter at its outer portion.
By this arrangement, end 28 of tube 26 defines a puncturable diaphragm accessible to a piercing spike 32, which is inserted in the bore of gripping sleeve 30 after removing cover 24 and forced through end 28 to gain access to the contents of container 10. Simultaneously, the broken end 28 is firmly pressed by spike 32 against the inner wall of tube 26 to provide an added pressure seal, to assure that parenteral solution does not leak out of the container around the spike. Additionally, tube 26 and sleeve 30 provides sealing against the outside of spike 32.
Hence, aseptic, nonleaking access to container 10 is provided by the pierceable access port of this invention.
Some spacing is typically provided between sleeve 30 and head 18 to provide added flexibility to access ports 20, 21 for ease of gripping and piercing.
The second access port 21 can be used for the addition of supplemental medication by a needle through latex plug 22 and the corresponding tube end 28, if desired.
The above has been offered for purposes of illustration only, and is not to be construed as limiting the invention of this application as defined by the claims.