Pierceable access port assembly

• US 3,905,368 A
• Filed: 02/15/1974
• Issued: 09/16/1975
• Est. Priority Date: 02/15/1974
• Status: Expired due to Term

• Current Assignee: Dan Lewis Jr, Myron R. Prouty, Raymond D. Von Alven
• Original Assignee: Dan Lewis Jr, Myron R. Prouty, Raymond D. Von Alven
• Inventors: Lewis, Dan Jr., Von Alven, Raymond D., Prouty, Myron R.
• Primary Examiner(s): Gaudet, Richard A.
• Assistant Examiner(s): Layton, Henry S.
• Application Number:
  US05/443,011
• Time in Patent Office: 578 Days
• Field of Search: 128/272,214D,DIG.24,227 150/.5,1 222/92,107,212,215
• US Class Current: 604/415
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1431 Permanent type, e.g. welded or glued
• CPC Class Codes: A61J 1/1462 Containers with provisions for hanging, e.g. integral adaptations of the container accessories for hanging the container A61M5/1414
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/1487 with friction fit, e.g. connecting tubes directly to a protruding port
• CPC Class Codes: A61J 1/18 Arrangements for indicating condition of container contents, e.g. sterile condition
• CPC Class Codes: Y10S 128/24 Medical-surgical bags

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.

Claims

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.