Dispenser and method for storing and dispensing sterile product

• US 8,220,507 B2
• Filed: 09/02/2010
• Issued: 07/17/2012
• Est. Priority Date: 10/16/2001
• Status: Expired due to Fees

• Current Assignee: Medical Instill Technologies Inc.
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel, Assion, Norbert M., Chan, Julian V.
• Primary Examiner(s): Douglas, Steve
• Application Number:
  US12/874,744
• Publication Number:
  US 20100331808A1
• Time in Patent Office: 684 Days
• Field of Search: 141/2, 141/18, 141/21, 141/27, 141/85, 141/329, 222/386, 222/390, 222/494, 222/563, 604/256, 604/415
• US Class Current: 141/329
• CPC Class Codes: A45D 2200/055 Piston or plunger for supplying the liquid to the applicator
• CPC Class Codes: A45D 34/04 Appliances specially adapted for applying liquid, e.g. using roller or ball
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 7/0053 Syringes, pipettes or oral dispensers
• CPC Class Codes: B05B 11/02 Membranes or pistons acting on the contents inside the container, e.g. follower pistons
• CPC Class Codes: B65D 51/002 Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining means
• CPC Class Codes: B67D 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G01F 11/027 of the syringe type

Abstract

A dispenser is provided for the delivery of controlled, metered amounts of any of numerous different substances to humans or animals, such as medicaments, pharmaceuticals, cosmetics, and food products, or to deliver materials that may react upon exposure to air, such as glue. Means are provided in the dispenser to effect controlled delivery of a pre-determined amount of the substance contained in the dispenser. A one-way valve is provided to hermetically seal the portion of the dispenser containing the substance to be dispensed.

Claims

1. A method for storing and dispensing a product, comprising the following steps:

i) maintaining a product hermetically sealed within a variable-volume storage chamber of a dispenser including a one-way valve coupled in fluid communication with the variable-volume storage chamber, wherein the one-way valve includes an elastic valve member forming a normally closed valve opening;

ii) dispensing a plurality of different portions of the product at different points in time from the variable-volume storage chamber through the one-way valve by pressurizing product at an inlet to the normally closed valve opening and in turn moving the elastic valve member between a normally closed position and an open position with at least a segment of the valve member spaced away from the closed position to allow the passage of product from the variable-volume storage chamber through the valve opening; and

iii) maintaining the product within the variable-volume storage chamber hermetically sealed with respect to ambient atmosphere throughout steps (i) and (ii).

2. A method as defined in claim 1, further comprising the following steps:

iv) sterile filling the variable-volume storage chamber with the product; and

v) hermetically sealing the product within the variable-volume storage chamber.

3. A method as defined in claim 2, further comprising the step of sterilizing the product prior to the step of sterile filling the variable-volume storage chamber with the product.

4. A method as defined in claim 2, further comprising the step of substantially preventing the ingress of air or other contaminants through the one-way valve and into the variable-volume storage chamber during steps (iv) and (v).

5. A method as defined in claim 4, further comprising the step of sterile filling the variable-volume storage chamber with a sterile product, and maintaining the product within the variable-volume storage chamber sterile throughout steps (i) through (v).

6. A method as defined in claim 1, further comprising the step of applying pressure to the product contained within a chamber of the dispenser and dispensing a portion of the product through the one-way valve.

7. A method as defined in claim 6, wherein the dispensing step includes dispensing a predetermined amount of product from the variable-volume storage chamber through the one-way valve.

8. A method as defined in claim 6, wherein the dispensing step includes dispensing a metered amount of product from the variable-volume storage chamber through the one-way valve.

9. A method as defined in claim 6, wherein the step of applying pressure to the product includes manipulating a device that exerts pressure on the product contained within a chamber of the dispenser and dispensing a portion of the product from the variable-volume storage chamber through the one-way valve.

10. A method as defined in claim 9, wherein the manipulating step includes manually manipulating the device and exerting pressure on the product contained with the chamber of the dispenser.

11. A method as defined in claim 1, wherein the product comprises a food product.

12. A method as defined in claim 1, wherein the product comprises one of a medicament, a drug and a pharmaceutical.

13. A method as defined in claim 1, wherein the dispenser includes a penetrable and resealable portion in fluid communication with the variable-volume storage chamber, and the method further comprises the steps of:

sterilizing an exposed surface of the penetrable and resealable portion;

penetrating the penetrable and resealable portion with a filling member coupled in fluid communication with a source of the product;

introducing the product through the filling member and into the variable-volume storage chamber;

withdrawing the filling member from the penetrable and resealable portion; and

resealing the penetrated region of the penetrable and resealable portion to seal the penetrated region and form a substantially gas-tight seal between the penetrated region and the variable-volume storage chamber.

14. A method as defined in claim 13, wherein the penetrable and resealable portion is thermally resealable, and the resealing step comprises applying sufficient thermal energy to the penetrated region of the penetrable and thermally resealable portion to fuse the penetrated region and form a substantially gas-tight seal between the penetrated region and the variable-volume storage chamber.

35. A method as defined in claim 13, wherein the resealing step comprises applying radiation or energy to the penetrated region of the penetrable and resealable portion.

15. A dispenser for storing and dispensing a product, comprising:

a variable-volume storage chamber, and a one-way valve coupled in fluid communication with the variable-volume storage chamber and including an elastic valve member forming a normally closed, valve opening, wherein the valve member is movable between a normally closed position, and an open position with at least a segment of the elastic valve member spaced away from the closed position to allow the passage of the product through the valve opening, the variable-volume storage chamber is filled with the product, the product is hermetically sealed in the variable-volume storage chamber, and the dispenser maintains the product within the variable-volume storage chamber hermetically sealed with respect to ambient atmosphere throughout dispensing a plurality of different portions of the product from the storage chamber through the one-way valve.

16. A dispenser as defined in claim 15, further comprising a housing including therein the variable-volume storage chamber.

17. A dispenser as defined in claim 15, further comprising a device that exerts pressure on the product contained within a chamber of the dispenser in order to dispense a plurality of different portions of the product from the variable-volume storage chamber through the one-way valve.

18. A dispenser as defined in claim 17, further comprising a mechanism coupled to the device to move the device, exert pressure on the product, and dispense a portion of the product through the one-way valve.

19. A dispenser as defined in claim 17, wherein the device dispenses metered amounts of the product through the one-way valve.

20. A dispenser as defined in claim 15, wherein the product stored within the variable-volume storage chamber is sterile, and the one-way valve and variable-volume storage chamber maintain the product within the variable-volume storage chamber sterile throughout storage and dispensing of product through the one-way valve.

21. A dispenser as defined in claim 15, wherein the product comprises a food product.

22. A dispenser as defined in claim 15, wherein the product comprises one of a medicament, a drug and a pharmaceutical.

23. A dispenser for storing product and dispensing multiple portions of the product therefrom, comprising:

a hermetically sealed, variable-volume storage chamber containing therein multiple portions of the product hermetically sealed with respect to ambient atmosphere;

a one-way valve comprising a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber, wherein the valve member is movable in response to product at the inlet to the valve opening exceeding a valve opening pressure between (i) a normally closed position and (ii) an open position with at least a segment of the valve member spaced away from the closed position to allow product to be dispensed through the valve opening; and

a device configured to exert pressure on product at the inlet of the valve opening to exceed the valve opening pressure and dispense a portion of the product through the one-way valve, wherein during dispensing of product through the one-way valve, the one-way valve and the variable volume storage chamber maintain the product remaining in the variable volume storage chamber sealed with respect to ambient atmosphere.

24. A dispenser as defined in claim 23, further comprising a manually-engageable mechanism coupled to the device to move the device, exert pressure on the product, and dispense a portion of the product through the one-way valve.

25. A dispenser as defined in claim 23, wherein the device is coupled in fluid communication between the variable-volume storage chamber and the one-way valve.

26. A dispenser as defined in claim 23, wherein the product is sterile, and the variable-volume storage chamber and one-way valve are configured to maintain the product in the variable-volume storage chamber sterile throughout dispensing product through the one-way valve.

27. A dispenser as defined in claim 23, wherein the product comprises a food product.

28. A dispenser as defined in claim 23, wherein the product comprises one of a medicament, a drug and a pharmaceutical.

34. A dispenser as defined in claim 23, wherein the valve member is movable radially and in the open position the at least a segment of the valve member is spaced radially away from the closed position.

29. A dispenser for storing and dispensing multiple portions of product, comprising:

a variable-volume storage chamber including a plurality of portions of product hermetically sealed therein;

means coupled in fluid communication with the variable-volume storage chamber for forming a normally closed opening, for moving between a normally closed position, and an open position with at least a segment of said means spaced away from the closed position to allow the passage of product through the opening, and for maintaining the product within the variable-volume storage chamber hermetically sealed with respect to ambient atmosphere throughout dispensing a plurality of different portions of the product from the storage chamber therethrough; and

a device configured to exert pressure on product at the opening and dispense a portion of the product through said means.

30. A dispenser as defined in claim 29, wherein the product in the variable-volume storage chamber is sterile, and said means maintains the product in the variable-volume storage chamber sterile throughout dispensing of portions of the product therethrough.

31. A dispenser as defined in claim 29, wherein said means is a one-way valve comprising a valve member formed of an elastic material and forming a normally closed valve opening and an inlet to the valve opening in fluid communication with the variable-volume storage chamber, the valve member is movable radially in response to product at the inlet to the valve opening exceeding a valve opening pressure between (i) a normally closed position and (ii) an open position with at least a segment of the valve member spaced radially away from the closed position to allow product to be dispensed through the valve opening.

32. A dispenser as defined in claim 29, wherein the product comprises a food product.

33. A dispenser as defined in claim 29, wherein the product comprises one of a medicament, a drug and a pharmaceutical.