Ambulatory energized container system

• US 5,738,657 A
• Filed: 12/19/1996
• Issued: 04/14/1998
• Est. Priority Date: 06/15/1992
• Status: Expired due to Fees

• Current Assignee: Hospira Incorporated (Pfizer Inc.)
• Original Assignee: Abbott Laboratories
• Inventors: Williams, John C., Mittag, Rodney M., Tripp, Edward S., Bryant, Peter L., Drivas, Nicolaos A., Rudzena, William L., Moore, John K.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): RUHL, DENNIS WILLIAM
• Application Number:
  US08/769,822
• Time in Patent Office: 481 Days
• Field of Search: 604/403, 604/408, 604/410, 604/411, 604/140, 604/141, 604/145, 604/122, 441/98-101, 441/30, 441/31, 222/95
• US Class Current: 604/145
• CPC Class Codes: A61M 2005/1403 Flushing or purging
• CPC Class Codes: A61M 39/225 Flush valves, i.e. bypass valves for flushing line
• CPC Class Codes: A61M 5/16804 Flow controllers
• CPC Class Codes: B01J 7/02 by wet methods

Abstract

An ambulatory infusion and/or KVO (keep vein open) system (12, 18) has a gas-pressurized bladder arrangement (12) including a gas barrier associated therewith. The system includes a flexible bag of solution (13) inserted in a sleeve portion (36) of the bladder arrangement (12). Internal gas pressure which is developed within the bladder arrangement by a selectively initiated chemical reaction exerts a continuing pressure against the solution bag (13) to cause the solution to flow therefrom. A tubing set (18) of the system includes a flow restrictor (24) which is sized for minimal flow rates for indwelling catheter patency maintenance.

Claims

1. An ambulatory energized container system for delivering a solution from a flexible bag of solution into a patient'"'"'s indwelling vein access device, said ambulatory energized container system comprising:

a combination sleeve and bladder member, said combination member having a bladder portion and a sleeve portion, said bladder member comprising first and second sheets of a laminar material, said first and second sheets welded together along a top weld line, said first and second sheets welded together along a bottom weld line substantially parallel to and spaced from said top weld line, said first and second sheets welded together along a first side weld line substantially perpendicular to said top and bottom weld lines, said first and second sheets welded together along a second side weld line substantially parallel to and spaced from said first side weld line, said first and second sheets welded together along a first corner weld line, said first corner weld line intersecting said top weld line and said first side weld line at substantially 135°

angles, said first and second sheets welded together along a second corner weld line, said second corner weld line intersecting said top weld line and said second side weld line at substantially 135°

angles, said first and second sheets welded together along a third corner weld line, said third corner weld line intersecting said bottom weld line and said second side weld line at substantially 135°

angles; and

said first and second sheets welded together along a fourth corner weld line intersecting said bottom weld line and said first side weld line at substantially 135°

angles;

gas-generating means disposed within said bladder portion, said gas-generating means comprising a first reactive composition, a second reactive composition, and a segregating means for segregating said first and second reactive compositions, said segregating means being openable by manual manipulation thereof resulting in an exposure of said first reactive composition to said second reactive composition, said first and second reactive compositions being selected such that exposure of said first reactive, composition to said second reactive composition produces a chemical reaction resulting in a formation of a volume of gas sufficient to expand said bladder portion.

2. An ambulatory energized container system in accordance with claim 1, wherein said laminar material comprises a plurality of lamina of varying elastic moduli, said plurality of lamina arranged in order of decreasing elastic moduli from an interior of said bladder member to an exterior of said bladder member.

3. An ambulatory energized container system for delivering a solution from a flexible bag into a patient'"'"'s indwelling vein access device, said ambulatory energized container system comprising:

a combination sleeve and bladder member, said combination member having a bladder portion and a sleeve portion, said bladder portion comprising a laminar material having a plurality of lamina of varying elastic moduli, said plurality of lamina arranged in order of decreasing elastic moduli from an interior of said bladder member to an exterior of said bladder member,

said sleeve portion being constructed of a flexible material and being capable of receiving therein a flexible container for solution in a position in said sleeve portion alongside said bladder portion of said combination member,

gas-generating means disposed within said bladder portion, said gas-generating means comprising a first reactive composition, a second reactive composition, and a segregating means for segregating said first and second reactive compositions, said segregating means being openable by manual manipulation thereof resulting in an exposure of said first reactive composition to said second reactive composition, said first and second reactive compositions being selected such that exposure of said first reactive composition to said second reactive composition produces a chemical reaction resulting in a formation of a volume of gas sufficient to expand said bladder portion.

4. The ambulatory energized container system of claim 3, wherein said gas-generating means is disposed within a barrier means for retaining moisture and debris, and wherein said barrier means for retaining moisture and debris is disposed within said bladder portion of said combination member.

5. The ambulatory energized container system of claim 3, wherein said gas-generating means contains quantities of said first and second reactive compositions sufficient to exert a pressure on said flexible bag for solution for at least 2 hours.

6. The ambulatory energized container system of claim 3, wherein said laminar material comprises an inner layer constructed of a fabric-reinforced polyurethane material, an intermediate, barrier layer constructed of a polyvinylidene chloride material, and an outer layer constructed of a non-reinforced polyurethane material.

7. The ambulatory energized container system of claim 3 wherein said system further comprises a means for signalling an empty condition of said flexible container, said means for signalling comprising an indicia on said sleeve portion of said combination bladder and sleeve member.

8. The ambulatory energized container system of claim 3, wherein said first reactive composition comprises sodium bicarbonate and wherein said second reactive composition comprises citric acid.

9. The ambulatory energized container system of claim 8, wherein said segregating means for segregating said gas-generating reactive chemical means comprises a frangible ampoule, and wherein one of said first and second reactive compositions is disposed within said frangible ampoule and the other of said first and second reactive compositions is disposed outside said frangible ampoule.