Fluid dispenser having a one-way valve, pump, variable-volume storage chamber, and a needle penetrable and laser resealable portion

• US 8,240,521 B2
• Filed: 02/10/2006
• Issued: 08/14/2012
• Est. Priority Date: 10/23/2000
• Status: Expired due to Term

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Medical Instill Technologies Inc.
• Inventors: Py, Daniel
• Primary Examiner(s): Shaver, Kevin P
• Assistant Examiner(s): CARTAGENA, MELVIN A
• Application Number:
  US11/351,716
• Publication Number:
  US 20060131338A1
• Time in Patent Office: 2,377 Days
• Field of Search: 222/95, 222/105, 222/386.5, 2224021-40225, 222491-494, 222/1
• US Class Current: 222/492
• 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: B05B 11/0072 A valve member forming part of an outlet opening
• CPC Class Codes: B05B 11/0097 Means for filling or refilling the sprayer through additional openings in the container B05B11/0056
• CPC Class Codes: B05B 11/026 Membranes separating the content remaining in the container from the atmospheric air to compensate underpressure inside the container
• CPC Class Codes: B05B 11/1004 comprising a movable cylinder and a stationary piston
• CPC Class Codes: B05B 11/1074 located outside pump chambers
• CPC Class Codes: B05B 11/1077 characterised by a particular shape or material B05B11/1076 takes precedence
• CPC Class Codes: B05B 11/1092 automatically released from a loaded state at the end of the loading stroke
• CPC Class Codes: B05B 11/1094 having inlet or outlet valves not being actuated by pressure or having no inlet or outlet valve
• CPC Class Codes: B65D 81/245 Internal membrane, floating cover or the like isolating the contents from the ambient atmosphere loosely-attached linings B65D25/16; dispensing pistons B65D83/0005; flexible bags for expelling the contents B65D83/0055
• CPC Class Codes: B65D 83/0055 Containers or packages provided with a flexible bag or a deformable membrane or diaphragm for expelling the contents

Abstract

A dispenser for dispensing a fluid includes a rigid vial that has a main fluid chamber containing a fluid, and a pump assembly that is in fluid communication with the main fluid chamber and is configured to dispense a predetermined quantity of fluid from the main fluid chamber. A flexible bladder is provided which is located within the main fluid chamber and is configured to expand to fill the ullage created within the main fluid chamber during dispensing of fluid by the pump assembly. The resilient bladder tends to force itself outwardly toward the rigid vial and, in turn, increases the pressure within the main fluid chamber in comparison to the interior of the bladder to thereby prevent the ingress of air or vapors through the bladder or otherwise into the main fluid chamber.

Claims

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

(i) storing a sterile fluid in a variable-volume storage chamber of a device hermetically sealed with respect to ambient atmosphere, wherein the device includes a housing, a flexible bladder received within the housing and defining the variable-volume storage chamber, and a one-way valve including an axially-extending valve seat and an elastic valve member having a thickness and forming an axially-extending interface with the valve seat defining an interference fit therewith, the interface having an axial extent greater than the thickness of the valve member and forming a normally closed axially-extending valve opening;

(ii) dispensing a plurality of different portions of the sterile fluid at different points in time from the variable-volume storage chamber through the one-way valve by pumping fluid along a path extending in a direction substantially parallel to an axis of the one-way valve at an inlet to the normally closed valve opening and, in turn, moving the 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 connect the valve opening in fluid communication with the variable-volume storage chamber and thereby allow the passage of fluid from the variable-volume storage chamber through the valve opening, wherein, substantially throughout any period of dispensing fluid through the valve opening, a segment of the valve member engages the valve seat to maintain a hermetic seal between the valve opening and ambient atmosphere; and

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

2. A method as defined in claim 1, wherein the dispensing step includes pumping with a manually-engageable pump the plurality of different portions of the sterile fluid at different points in time from the variable-volume storage chamber through the one-way valve.

3. A method as defined in claim 1, further comprising the steps of:

sterilizing the variable-volume storage chambe while empty; and

sterile filling the variable-volume storage chamber with the sterile fluid.

4. A method as defined in claim 1, wherein the dispensing step includes pumping the plurality of different portions of the sterile fluid at different points in time from the variable-volume storage chamber through the one-way valve.

5. A method as defined in claim 1, wherein the path is substantially straight.

6. A device for storing and dispensing a sterile fluid, comprising:

a relatively rigid outer body, a flexible inner bladder received within the outer body and defining a variable-volume storage chamber, and a one-way valve including an axially-extending valve seat and an elastic valve member having a thickness and forming an axially-extending interface with the valve seat defining an interference fit therewith, the interface having an axial extent greater than the thickness of the valve member and defining a normally closed, axially-extending valve opening, and an inlet to the axially-extending interface defining a fluid flow path in communication with the variable volume storage chamber and extending in a direction substantially parallel to an axis of the one-way valve, 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 connect the valve opening in fluid communication with a sterile fluid from the variable-volume storage chamber and thereby allow the passage of the sterile fluid through the valve opening, wherein the valve member is configured so that substantially throughout any period of dispensing fluid through the valve opening, a segment of the valve member engages the valve seat to maintain a hermetic seal between the inlet and ambient atmosphere, the variable-volume storage chamber is filled with the sterile fluid, the sterile fluid is hermetically sealed in the variable-volume storage chamber, and the flexible bladder and one-way valve maintain the sterile fluid within the variable-volume storage chamber sterile and hermetically sealed with respect to ambient atmosphere throughout dispensing a plurality of different portions of the sterile fluid from the storage chamber through the one-way valve.

7. A device as defined in claim 6, further comprising a pump for pumping a plurality of different portions of the sterile fluid from the variable-volume storage chamber through the one-way valve.

8. A device as in claim 6, wherein the path is substantially straight.

9. A device as in claim 6, wherein the valve seat is conically-shaped at the valve opening.

10. A device for storing sterile fluid and dispensing multiple portions of the stored fluid therefrom, comprising:

an outer body;

a flexible bladder received within the outer body and defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of sterile fluid hermetically sealed with respect to ambient atmosphere;

a one-way valve comprising an axially-extending valve seat and a valve member having a thickness and formed of an elastic material and forming an axially-extending interface with the valve seat defining an interference fit therewith, the interface having an axial extent greater than the thickness of the valve member and defining a normally closed valve opening and an inlet to the valve opening defining a fluid flow path in communication with the variable volume storage chamber and extending in a direction substantially parallel to an axis of the one-way valve, wherein the valve member is movable radially in response to sterile fluid 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 connect the valve opening in fluid communication with the sterile fluid and thereby allow the sterile fluid to be dispensed through the valve opening, wherein the valve member is configured so that substantially throughout any period of dispensing fluid through the valve opening, a segment of the valve member engages the valve seat to maintain a hermetic seal between the inlet and ambient atmosphere, and wherein during dispensing of fluid through the one-way valve, the one-way valve and storage chamber maintain fluid remaining in the storage chamber sterile and sealed with respect to ambient atmosphere; and

a pump coupled between the variable-volume storage chamber and one-way valve and configured to pump sterile fluid from the storage chamber and into the valve opening to dispense the fluid therethrough.

11. A device as defined in claim 10, wherein the one-way valve further includes a valve body defining the axially-extending valve seat and a flow aperture extending through at least one of the valve body and the valve seat, the elastic valve member includes an axially-extending valve portion overlying the valve seat and covering a substantial axially-extending portion thereof, the valve portion and the valve seat define an axially-extending seam therebetween forming the valve opening, and the valve portion engages the valve seat in the closed position.

12. A device as defined in claim 11, wherein the valve portion includes said segment that engages the valve seat substantially throughout any period of dispensing fluid through the valve opening to maintain a hermetic seal between the valve opening and ambient atmosphere, and said segment is substantially annular.

13. A device as defined in claim 10, wherein the variable-volume storage chamber stores the sterile fluid therein in a substantially airless condition during shelf life and dispensing of sterile fluid through the one-way valve.

14. A device as in claim 10, wherein the path is substantially straight.

15. A method for storing sterile fluid and dispensing multiple portions of the stored sterile fluid therefrom, comprising the following steps:

storing a sterile fluid in a variable-volume storage chamber of a device hermetically sealed with respect to ambient atmosphere, wherein the device includes a housing, a flexible bladder received within the housing and defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of sterile fluid hermetically sealed with respect to ambient atmosphere, and a one-way valve comprising an axially-extending valve seat and a valve member having a thickness and formed of an elastic material and forming an axially-extending interface with the valve seat defining an interference fit therewith, the interface having an axial extent greater than the thickness of the valve member and forming a normally closed, axially-extending valve opening and an inlet to the valve opening;

pumping sterile fluid along a path extending in a direction substantially parallel to an axis of the one-way valve at the inlet to the valve opening to a pressure at least equal to a valve opening pressure and, in turn, moving the elastic valve member 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 and, in turn, dispensing sterile fluid from the variable-volume storage chamber through the valve opening, wherein substantially throughout any period of dispensing fluid through the valve opening, a segment of the valve member engages the valve seat to maintain a hermetic seal between the inlet and ambient atmosphere; and

during dispensing of fluid through the one-way valve, maintaining fluid remaining in the storage chamber sterile and sealed with respect to ambient atmosphere.

16. A method as defined in claim 15, further comprising the step of pumping fluid from the storage chamber and into the valve opening to dispense the fluid therethrough.

17. A method as defined in claim 15, wherein the path is substantially straight.

18. A device for storing sterile fluid and dispensing multiple portions of the stored fluid therefrom, comprising:

an outer body;

a flexible bladder received within the outer body and defining a hermetically sealed, variable-volume storage chamber containing therein multiple portions of sterile fluid hermetically sealed with respect to ambient atmosphere;

means for forming an axially-extending interface with a valve seat defining an interference fit therewith and a normally closed opening and an inlet to the opening defining a fluid flow path in communication with the variable volume storage chamber and extending in a direction substantially parallel to an axis of the axially-extending interface, the means also for moving in response to fluid at the inlet to the opening exceeding an opening pressure between (i) a normally closed position and (ii) an open position with at least a segment of said means spaced radially away from the closed position to thereby allow sterile fluid from the variable-volume storage chamber to be dispensed through the opening, for forming a segment that engages the valve seat substantially throughout any period of dispensing fluid through the valve opening to maintain a hermetic seal between the inlet and ambient atmosphere, and for maintaining fluid remaining in the storage chamber sterile and sealed with respect to ambient atmosphere during dispensing of fluid through said means, wherein said means defines a thickness, and the axially-extending interface defines an axial extent greater than the thickness; and

a pump coupled between the variable-volume storage chamber and said means and configured to pump fluid from the storage chamber and into the opening to dispense the fluid therethrough.

19. A device as defined in claim 18, 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, wherein the valve member is movable radially in response to fluid at the inlet to the valve opening exceeding a valve opening pressure between (i) the normally closed position and (ii) the open position with at least a segment of the valve member spaced radially away from the closed position to connect the valve opening in fluid communication with the variable-volume storage chamber and thereby allow fluid from the variable-volume storage chamber to be dispensed through the valve opening.

20. A device as in claim 18, wherein the path is substantially straight.