Device for administration of enteral fluids from pre-filled shape retentive containers

• US 4,921,138 A
• Filed: 07/29/1988
• Issued: 05/01/1990
• Est. Priority Date: 01/15/1988
• Status: Expired due to Fees

• Current Assignee: CORPAK MedSystems, Inc. (Avanos Medical, Inc.)
• Original Assignee: Corpak LLC
• Inventors: Quinn, David G., Andersen, Erik, Edwards, Robert B. II
• Primary Examiner(s): Shaver, Kevin P.
• Assistant Examiner(s): Huson, Gregory L.
• Application Number:
  US07/226,380
• Time in Patent Office: 641 Days
• Field of Search: 222/80, 222/81, 222/83.5, 222/85, 222/86, 222/88, 222/105, 222/155, 222/158, 222/159, 222/49, 222/50, 222/180, 222/181, 222/183, 222/185, 222/189, 222/475, 222/478, 222/481 , 222/481.5, 222/541, 294/22, 294/103.1, 294/902, 294/34, 248/311.2, 248/313, 248/318, 248/231.4, 248/316.4, 604/262, 604/405, 604/406, 604/246, 604/257, 604/260, 604/411, 604/414, 141/329, 141/330, 220/284, 220/278, 220/18, 220/450, 220/454, 220/458, 220/461
• US Class Current: 222/85
• CPC Class Codes: A61M 2005/1623 Details of air intake
• CPC Class Codes: A61M 5/1417 Holders or handles for hanging up infusion containers
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: B67B 7/26 combined with spouts
• CPC Class Codes: B67B 7/28 and associated with receptacle hodlers
• CPC Class Codes: F01K 23/101 Regulating means specially adapted therefor F01K23/105, F01K23/108 take precedence

Abstract

An improved device for aspetic dispensing of enteral feeding solutions from shape retentive, pre-filled containers. The device including a distensible hanger member formed around only the end panels of the container to suspend the container in an orientation to define only a single uppermost corner and a single lowermost corner. The device further including corner attachment members for firmly securing a therapeutic fluid dispensing column only to the uppermost and lowermost corners of the container. The fluid dispensing column having venting and dispensing spikes. The spikes having an outer configuration which forms leak-proof seals with an aperture formed in the container. The spikes further including an arrangement of laterally opposed inlet ports joined to a large diameter axial bore.

Claims

1. A device for aseptic dispensing of therapeutic fluids from a shape retentive container having a plurality of corners, two opposing face panels and a plurality of side panels, comprising:

distensible and formable hanger means for suspending the container in such an orientation to define one uppermost corner and one lowermost corner, the hanger means being wrapped and formed around only the side panels of the container;

means for dispensing therapeutic fluid from the container, said dispensing means having at least an uppermost spike for penetrating the container near the uppermost corner and a lowermost spike for penetrating the container near the lowermost corner, said spikes each having an axial bore being in fluid communication through an enclosed passage in the dispensing means, the uppermost spike venting ambient air into the container through an upper end of the passage, the lowermost spike dispensing fluid out of the container through a lower end of the passage; and

,

one corner member for attachment to only the uppermost corner of the container, an other corner member detached from the one corner member, the other corner member for attachment to only the lowermost corner of the container, each of said corner members being carried on the means for dispensing therapeutic fluid, the uppermost spike passing through the one corner member, the lowermost spike passing through the other corner member.

2. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 1 wherein the distensible hanger means wraps around only the side panels of the container.

3. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 1 wherein one face panel of the container includes:

at least one removable segment for concealing areas of one face panel for inserting a spike; and

a two-sided adhesive layer adhered to the area of one face panel and underneath the removable segment.

4. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 3 wherein the one face panel of the container includes one removable tab concealing an area near the uppermost corner of the container and an other removable tab concealing an area near the lowermost corner of the container.

5. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 1 wherein each corner member includes two legs being in an angular orientation corresponding to the angle defined by the corner of the container, the legs each having an inner surface for abutting against a portion of the side panels of the carton proximate to the corner, the legs being joined to each other by at least one brace member, each corner member having an apex defined by the intersection of the legs, the spikes for penetrating the uppermost corner and lowermost corner of the carton being positioned proximate to the apex of each corner member.

6. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 5 wherein the inner surface of each leg includes ribs for facilitating insertion of the uppermost corner and lowermost corner into each corner member.

7. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 5 wherein the brace member includes an opening to permit passage of the spike.

8. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 1 wherein the fluid passage includes a transparent tubular column.

9. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 8 wherein the container includes:

graduated volumetric indicia positioned parallel to the tubular column.

10. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 8 wherein the container includes:

columnar indicia being applied to the container and visible through the tubular column, the indicia being color contrasting to the therapeutic fluid to permit a user to ascertain the volume of fluid within the container by aligning the meniscus of fluid within the column with a volumetric marking of the columnar indicia.

11. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 8 wherein an uppermost end of the tubular column carries a filtered vent for screening debris from ambient air.

12. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 1 wherein the uppermost spike and the lowermost spike each include:

a conical tip portion for initially forming an aperture in the container, the tip portion having side walls defining an axially centered point;

a body portion joined to the tip portion, the body portion having side walls less angularly inclined than the side walls of the conical portion;

a generally cylindrical base portion joined to the body portion, the base portion having an axial bore for passing fluid into the channel; and

a plurality of fluid inlet ports positioned near the junction of body portion and the base portion, the ports being in fluid communication with the axial bore of the base portion.

13. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 12 wherein the conical tip portion, the body portion and the base portion are integrally formed to define a unitary spike structure.

14. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 12 wherein the inlet ports are positioned in the base portion.

15. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 12 wherein the inlet ports are in fluid communication with a lateral bore, the lateral bore being perpendicular to and in fluid communication with the axial bore in the base portion.

16. A device for aseptic dispensing of therapeutic fluids from a shape retentive container having a plurality of corners, two opposing face panels and a plurality of side panels, comprising:

means for suspending the container in such an orientation to define one uppermost corner and one lowermost corner, the suspending means being wrapped and formed around the container without contacting the two opposing face panels of the container;

means for dispensing therapeutic fluid from the container, said dispensing means having at least an uppermost spike for penetrating the container near the uppermost corner and a lowermost spike for penetrating the container near the lowermost corner, said spikes each having an axial bore being in fluid communication through an enclosed passage, the uppermost spike venting ambient air into the container through an upper end of the passage, the lowermost spike dispensing fluid out of the container through a lower end of the passage; and

,

one corner member for attachment to only the uppermost corner of the container, an other corner member detached from the one corner member, the other corner member for attachment to only the lowermost corner of the container, each of said corner members being carried on the dispensing means, the uppermost spike passing through the one corner member, the lowermost spike passing through the other corner member.

17. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 16 wherein the uppermost spike and the lowermost spike each include:

a conical tip portion for initially forming an aperture in the container, the tip portion having side walls defining an axially centered point;

a body portion joined to the tip portion, the body portion having side walls less angularly inclined than the side walls of the conical portion;

a generally cylindrical base portion joined to the body portion, the base portion having an axial bore for passing fluid into the channel; and

a plurality of fluid inlet ports positioned near the junction of body portion and the base portion, the ports being in fluid communication with the axial bore of the base portion.

18. A device for aseptic dispensing of therapeutic fluids from a shape retentive container having a plurality of corners, two opposing face panels and a plurality of side panels, the container being formed by folding and adhering a sheet of container material, the container having at least one corner fold extending from one end panel and being normally adhered onto an adjacent side panel, the one corner fold may be detached from the adjacent side panel and bent outward, comprising:

hanger means for suspending the container in such an orientation to define one uppermost corner and one lowermost corner, the hanger means suspending the container only from the detached one corner fold;

means for dispensing therapeutic fluid from the container, said dispensing means having at least an uppermost spike for penetrating the container near the uppermost corner and a lowermost spike for penetrating the container near the lowermost corner, said spikes each having an axial bore being in fluid communication through an enclosed passage in the dispensing means, the uppermost spike venting ambient air into the container through an upper end of the passage, the lowermost spike dispensing fluid out of the container through a lower end of the passage; and

,

one corner member for attachment to only the uppermost corner of the container, an other corner member detached from the one corner member, the other corner member for attachment to only the lowermost corner of the container, each of said corner members being carried on the means for dispensing therapeutic fluid, the uppermost spike passing through the one corner member, the lowermost spike passing through the other corner member.

19. The device for aseptic dispensing of therapeutic fluids from a shape retentive container described in claim 18 wherein the hanger means includes:

a rigid hanger having a pocket for receiving the one corner fold and a tab member having an aperture, the pocket and tab member being joined in a relative angular configuration to suspend the container in said orientation defining one uppermost corner and one lowermost corner.

20. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 18 wherein the uppermost spike and the lowermost spike each include:

a conical tip portion for initially forming an aperture in the container, the tip portion having side walls defining an axially centered point;

a body portion joined to the tip portion, the body portion having side walls less angularly inclined than the side walls of the conical portion;

a generally cylindrical base portion joined to the body portion, the base portion having an axial bore for passing fluid into the channel; and

a plurality of fluid inlet ports positioned near the junction of body portion and the base portion, the ports being in fluid communication with the axial bore of the base portion.

21. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 20 wherein the conical tip portion, the body portion and the base portion are integrally formed to define a unitary spike structure.

22. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 20 wherein the laterally opposed inlet ports are positioned in the base portion.

23. The device for aseptic dispensing of therapeutic fluids from shape retentive containers described in claim 20 wherein the laterally opposed inlet ports are in fluid communication with a lateral bore, the lateral bore being perpendicular to and in fluid communication with the axial bore in the base portion.