Preservative free sterile fluid dispensing system

• US 5,310,094 A
• Filed: 11/15/1991
• Issued: 05/10/1994
• Est. Priority Date: 11/15/1991
• Status: Expired due to Fees

• Current Assignee: Jsp Partners, L.P.
• Original Assignee: Jsp Partners, L.P.
• Inventors: Bystrom, Steven R., Chan, Peter W., Martinez, F. Jesus
• Primary Examiner(s): Kashnikow, Andres
• Assistant Examiner(s): Kaufman, J. A.
• Application Number:
  US07/792,989
• Time in Patent Office: 907 Days
• Field of Search: 222/189, 222/212, 222/215, 222/476, 222/494, 137/512, 137/846, 137/849
• US Class Current: 222/212
• CPC Class Codes: A61F 9/0008 Introducing ophthalmic products into the ocular cavity or retaining products therein putting in contact lenses A61F9/0061; introducing or retaining media in cavities of the body in general A61M31/00
• CPC Class Codes: A61J 1/145 using air filters
• CPC Class Codes: B05B 11/00444 with provision for filtering or cleaning the air flow drawn into the container
• CPC Class Codes: B05B 11/0075 Two outlet valves being placed in a delivery conduit, one downstream the other
• CPC Class Codes: B05B 11/047 characterised by the outlet or venting means B05B11/041 and B05B11/042 take precedence
• CPC Class Codes: B65D 47/18 for discharging drops; Droppers droppers in general B01L3/00; pipettes connected to container closures B01L3/0282
• CPC Class Codes: B65D 81/24 Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with thermal insulation B65D81/38
• CPC Class Codes: F16K 15/1472 the closure elements being fixed onto an internally extending mount
• CPC Class Codes: Y10T 137/7838 Plural
• CPC Class Codes: Y10T 137/7882 Having exit lip

Abstract

A fluid dispensing system for delivering sterile preservative free solution is disclosed. The system uses double self-sealing valves mounted in series inside a tip compartment which fits on the outlet of a multiple dosage squeeze container to prevent undesirable retrograde flow of the dispensed liquid back into the bottle during the decompression cycle. The valves used are positive acting, normally closed duckbill valves which open to express solution from the container when squeezing pressure is applied to the bottle and which automatically close when the pressure is released. A hydrophobic filter is provided to sterilize the replacement air which enters the container upon release of the squeezing pressure.

Claims

1. A fluid dispensing system for dispensing sterile preservative free solution comprising:

a container having an outer surface and an inner surface;

said container further having a reservoir compartment for storing a sterile solution and a tip compartment adapted to dispense the sterile solution;

said container further having at least part of it elastically deformable;

a dual self-sealing valve dispensing assembly sealed to the inside surface of said tip compartment;

wherein said dual self-sealing valve dispensing assembly further comprises;

a membrane assembly having a membrane housing;

a hydrophobic membrane support connected to said membrane housing;

said hydrophobic membrane support further having a top surface, a bottom surface and a central fluid channel to allow the sterile solution to pass through;

a hydrophobic membrane hermetically sealed to said bottom surface of said hydrophobic membrane support separating said reservoir compartment from said tip compartment, said membrane further connected to a central solution flow port which in turn communicates with said fluid channel of said hydrophobic membrane support to allow the solution to pass through;

a passageway located in said hydrophobic membrane support for ingress of air from outside said container through said hydrophobic membrane;

a valve assembly comprising a vale housing support with a top surface and a bottom surface;

said bottom surface of said valve housing support further connected to said top surface of said hydrophobic membrane support;

a first self-sealing valve hermetically sealed to said bottom surface of said housing support;

a second self-sealing valve hermetically sealed to said top surface of said valve housing support and in series with said first self-sealing valve wherein an outlet of said first valve opened to an inlet of said second valve to allow the solution to pass through; and

a system outlet from which the solution from an outlet of said second valve passes through.

2. A fluid dispensing system of claim 1, wherein said membrane housing is constructed of a thermoplastic material.

3. A fluid dispensing system of claim 2, wherein said thermoplastic material is selected from the group consisting of polyethylene, polypropylene, polystyrene, ethylene-vinyl acetate and combinations thereof.

4. A fluid dispensing system of claim 2, wherein said hydrophobic support is constructed of a thermoplastic material.

5. A fluid dispensing system of claim 4, wherein said thermoplastic material is selected from the group consisting of polyethylene, polypropylene, polystyrene, ethylene-vinyl acetate and combinations thereof.

6. A fluid dispensing system of claim 4, wherein said hydrophobic membrane is constructed of a hydrophobic polymer.

7. A fluid dispensing system of claim 6, wherein said hydrophobic polymer is selected from the group consisting of polyfluoroolefins, polyolefins and combinations thereof.

8. A fluid dispensing system of claim 7, wherein said hydrophobic membrane further has a pore size of about 0.01 to about 1 micron.

9. A fluid dispensing system of claim 8, wherein said hydrophobic membrane further has a pore size of about 0.2 to about 0.24 micron.

10. A fluid dispensing system of claim 9, wherein said hydrophobic membrane is suitable for resisting the passage of bacterial and microbial contamination and has a surface area of about 0.1 to about 0.2 cm².

11. A fluid dispensing system of claim 10, wherein said hydrophobic membrane is suitable for resisting the passage of bacterial and microbial contamination and has a surface area of about 0.13 cm².

12. A fluid dispensing system of claim 9, wherein said housing support is constructed of polyolefins and combinations thereof.

13. A fluid dispensing means of claim 12, wherein said first-sealing valve is a normally closed deformable duckbill valve.

14. A fluid dispensing system of claim 13, wherein said second sealing valve is a normally closed deformable duckbill valve.

15. A fluid dispensing system of claim 14, wherein said system outlet is further provided with a cap having bayonet extension means which displaces residual fluid and hermetically seals said outlet upon closure.

16. A fluid dispensing system of claim 15, wherein said cap is further provided with antislip knurls and threads for sealing to said outlet.

17. A fluid dispensing system of claim 15, wherein said cap is further rendered bactericidal and bacteriostatic with an agent selected from the group consisting of sliver oxide, gold oxide and copper oxide.

18. A fluid dispensing system of claim 14, wherein said system outlet is of a dimension of about 0.050 to about 0.127 cm.

19. A fluid dispensing system for dispensing sterile, preservative-free solutions comprising:

a container having at least part of it elastically deformable;

said container further having an outer surface and an inner surface;

said container further having a reservoir compartment for storing a sterile solution and a tip compartment adapted to dispense the sterile solution;

a dual self-sealing valve dispensing assembly sealed to the inside surface of said tip compartment;

said dual self-sealing valve dispensing assembly further comprising;

a membrane assembly having a polyethylene membrane housing;

a polyethylene hydrophobic membrane support connected to said polyethylene membrane housing;

said polyethylene hydrophobic membrane support further having a top surface, a bottom surface and a central fluid channel to allow the sterile solution to pass through;

a tetrafluoroethylene polymer hydrophobic membrane hermetically sealed to said bottom surface of said polyethylene hydrophobic membrane support separating said reservoir compartment from said tip compartment;

said tetrafluoroethylene polymer hydrophobic membrane further being connected to a central solution flow port which in turn communicates with said fluid channel of said hydrophobic membrane support to allow the solution to pass through;

said tetrafluoroethylene polymer hydrophobic membrane further having a pore size of about 0.22 micron and a surface area of about 0.13 cm² ;

a passageway located in said hydrophobic membrane support for ingress of air from outside said container through said tetrafluoroethylene polymer hydrophobic membrane;

a valve assembly comprising a valve housing support with a top surface and a bottom surface;

said bottom surface of said valve housing support further connecting to said top surface of said hydrophobic membrane support;

a first normally closed deformable self-sealing duckbill valve hermetically sealed to said bottom surface of said housing support;

a second normally closed deformable self-sealing duckbill valve hermetically sealed to said top surface of said valve housing support and in series with said first normally closed deformable self-sealing duckbill valve wherein an outlet of said first normally closed deformable self-sealing duckbill valve opens to an outlet of said second normally closed deformable self-sealing duckbill valve to allow the solution to pass through; and

a system outlet of a dimension of about 0.050 to about 0.127 cm from which the solution from an outlet of said second normally closed deformable self-sealing duckbill valve passes through.