Continuously sealing one way valve assembly and fluid delivery system and formulations for use therein

Abstract

A reusable continuously sealing one-way valve assembly and delivery system flows a sterile flowable substance from a source to an outlet orifice and prevents any backflow of contaminants through the continuously sealing one way valve assembly when the flowable substance ceases to flow. The valve assembly includes an elastomeric membrane which aids in preventing any backflow of contaminants when dispensing of the flowable substance is stopped. Multiple dosing of preservative-free flowable substance is provided.

1 . A continuously sealing one way valve assembly and delivery system for dispensing a flowable substance, comprising:
 a source for storage of the flowable substance, the source having an opening;   a valve assembly coupled to the opening of the source, said valve assembly including
 (i) an inner core having an inlet opening for receiving the flowable substance into a passageway and at least one port opening from the passageway, 
 (ii) a hollow flexible membrane having a first end and a second end, the first end being thicker than the second end, wherein the hollow flexible membrane is fitted over an outer surface of the inner core and when the flowable substance is placed under pressure the flowable substance exits through the at least one port opening and expands said membrane outwardly from said outer surface of said inner core; 
   a cover enclosing the flexible membrane and having an outlet orifice for dispensing the flowable substance from the valve assembly when pressure is applied to the flowable substance and   wherein when the pressure on the flowable substance is released, the first end of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of the inner core before the remainder of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of said inner core.   
   
   
       2 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the hollow flexible membrane has an axially extending uninterrupted continuous band at the first end of the hollow flexible membrane adjacent the outlet orifice in the cover and completely encircling the core. 
   
   
       3 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein said membrane has a radially outwardly extending flange at the second end thereof adjacent to the passageway of the inner core, and the cover also has a radially outwardly extending flange pressing the flange on the membrane into fluid tight contact with a radially outwardly extending flange at the passageway opening into the inner core. 
   
   
       4 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 3 , wherein a collar and connector member on the source secure the valve assembly to the source. 
   
   
       5 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 4  wherein the connector member is a threaded screw which mates to the collar. 
   
   
       6 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 4  wherein a collar and connector member on the source secure the valve assembly to the source and effect a positive lock preventing opening of the source. 
   
   
       7 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the outlet orifice in the cover is arranged so that it can dispense a selected quantity of the flowable substance. 
   
   
       8 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the outlet orifice in the cover is formed of a soft material. 
   
   
       9 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the outlet orifice in the cover is formed of a flexible material. 
   
   
       10 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the cover is formed of an inner axially extending flexible member laterally enclosed by an axially extending rigid plastic shell. 
   
   
       11 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein an overcap is arranged to fit over and form a seal with said valve assembly sufficient to prevent external contamination from coming in contact with the valve assembly during storage. 
   
   
       12 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein at least two ports extend from the passageway through the inner core and to the inner surface of the flexible membrane. 
   
   
       13 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the source comprises a collapsible reservoir reducible in volume in proportion as the flowable substance is dispensed from of the collapsible reservoir. 
   
   
       14 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 13 , wherein said collapsible reservoir is one of a bellows, a tube and an internal bag. 
   
   
       15 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein an axially extending housing laterally encloses the source. 
   
   
       16 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 15 , wherein the housing has a slot extending in the axial direction for applying dispensing pressure to an actuator of the collapsible reservoir. 
   
   
       17 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the cover has a closed outlet orifice which opens for dispensing the flowable substance from the cover when dispensing pressure is applied to the source. 
   
   
       18 . A continuously sealing one way valve assembly and delivery system, as set forth in  claim 17 , wherein the outlet orifice in the cover is impervious to the flowable substance and does not retain the flowable substance inwardly of the outlet orifice. 
   
   
       19 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1  wherein the inner core is connected to a pump assembly and to an actuator such that flowable substance is dispensed from the outlet orifice when the actuator is depressed. 
   
   
       20 . A one-way valve assembly and delivery system of  claim 1 , wherein the source is filled with a preservative free product. 
   
   
       21 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product is selected from one of opthalmological products, otorhinolarygological products, dermatological products, gynecological products, and products for the treatment or prevention of anorectal disorders, dermatological disorders, pulmonary disorders or any product which can be administered to the body through mucus membranes. 
   
   
       22 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of methycellulose, hyaluronic acid, polyethelene glycol 400 0.4%, propylene glycol 0.3%, glycerin, and mineral oils. 
   
   
       23 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of timolol 0.25%/0.50%, brimonidine tartrate 0.1%, bimatoprost 0.03% and travaprost 0.004%. 
   
   
       24 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of olopatadine HCL 0.1% and prednisolone acetate 1%. 
   
   
       25 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of ketorolac 0.5% and diclofenac 0.1%. 
   
   
       26 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of phenylephrine 0.25% and pseudoephedrine 30 mg. 
   
   
       27 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of skin preparations; scalp preparations; corticosteroid creams, lotions and ointments; topical antibiotics and topical anti-fungal agents. 
   
   
       28 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of skin preparations; scalp preparations; corticosteroid creams, lotions and ointments; topical antibiotics; topical anti-fungal agents; therapeutic skin creams including anti-bacterial, anti-fungal/parasitic, allergic and non-specific dermatitis creams and emollients and cosmetic dermatologic compounds used for dermatologic disorders 
   
   
       29 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of creams, topical anaesthetics, lubricating jellies and other preparations for hemorrhoid treatment, prevention or management. 
   
   
       30 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of B-adrenergic, anticholinergic, corticosteroid and theophyline derivatives. 
   
   
       31 . A one-way valve assembly and delivery system of  claim 20  wherein said preservative-free product comprises a product selected from one of azoles, nystatins, butoconazole, butoconalzole 2%, clotrimazole, clotrimazole 1%, metronidazole and trichomonas treatments. 
   
   
       32 . A one-way valve assembly and delivery system of  claim 19 , wherein said product is a contact lens care product. 
   
   
       33 . A one-way valve assembly and delivery system of  claim 19 , wherein said product is selected from one of: herbal, cosmetic, eye wash or skin care products. 
   
   
       34 . A continuously sealing one way valve assembly and delivery system as set forth in  claim 1 , wherein the continuously sealing one way valve assembly and delivery system can dispense multiple doses of preservative-free product. 
   
   
       35 . A continuously sealing one way valve assembly and delivery system for dispensing a preservative-free flowable substance, comprising:
 a source for storage of the preservative-free flowable substance, the source having an opening;   a valve assembly coupled to the opening of the source, said valve assembly including
 (i) an inner core having an inlet opening for receiving the preservative-free flowable substance into a passageway and at least one port opening from the passageway, 
 (ii) a hollow flexible membrane having a first end and a second end, the first end being thicker than the second end, wherein the hollow flexible membrane is fitted over an outer surface of the inner core and when the preservative-free flowable substance is placed under pressure the preservative-free flowable substance exits through the at least one port opening and expands said membrane outwardly from said outer surface of said inner core; 
   a cover enclosing the flexible membrane and having an outlet orifice for dispensing the preservative-free flowable substance from the valve assembly when pressure is applied to the preservative-free flowable substance and   wherein when the pressure on the preservative-free flowable substance is released, the first end of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of the inner core before the remainder of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of said inner core.   
   
   
       36 . A continuously sealing one way valve assembly and delivery system for dispensing multiple doses of a preservative-free flowable substance, comprising:
 a source for storage of the preservative-free flowable substance, the source having an opening;   a valve assembly coupled to the opening of the source, said valve assembly including
 (i) an inner core having an inlet opening for receiving the preservative-free flowable substance into a passageway and at least one port opening from the passageway, 
 (ii) a hollow flexible membrane having a first end and a second end, the first end being thicker than the second end, wherein the hollow flexible membrane is fitted over an outer surface of the inner core and when the preservative-free flowable substance is placed under pressure the preservative-free flowable substance exits through the at least one port opening and expands said membrane outwardly from said outer surface of said inner core; 
   a cover enclosing the flexible membrane and having an outlet orifice for dispensing the preservative-free flowable substance from the valve assembly when pressure is applied to the preservative-free flowable substance and   wherein when the pressure on the preservative-free flowable substance is released, the first end of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of the inner core before the remainder of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of said inner core.   
   
   
       37 . A delivery system comprising:
 a source for storage of a flowable substance, the source having an opening;   a valve assembly coupled to the opening of the source, said valve assembly including
 (i) an inner core having an inlet opening for receiving the flowable substance into a passageway and at least one port opening from the passageway, 
 (ii) a hollow flexible membrane having a first end and a second end, the first end being thicker than the second end, wherein the hollow flexible membrane is fitted over an outer surface of the inner core and when the flowable substance is placed under pressure the flowable substance exits through the at least one port opening and expands said membrane outwardly from said outer surface of said inner core; 
   a cover enclosing the flexible membrane and having an outlet orifice for dispensing the flowable substance from the valve assembly when pressure is applied to the flowable substance and   wherein when the pressure on the flowable substance is released, the first end of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of the inner core before the remainder of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of said inner core.   
   
   
       38 . A continuously sealing one way valve assembly and delivery system for dispensing a flowable substance, comprising:
 a source for storage of the flowable substance, the source having an opening;   a valve assembly coupled to the opening of the source, said valve assembly including
 (i) an inner core having an inlet opening for receiving the flowable substance into a passageway and at least one port opening from the passageway, 
 (ii) a hollow flexible membrane having a first end and a second end, the first end being thicker than the second end, wherein the hollow flexible membrane is fitted over an outer surface of the inner core and when the flowable substance is placed under pressure the flowable substance exits through the at least one port opening and expands said membrane outwardly from said outer surface of said inner core; 
   a cover enclosing the flexible membrane and having an outlet orifice for dispensing the flowable substance from the valve assembly when pressure is applied to the flowable substance and   wherein when the pressure on the flowable substance is released, the first end of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of the inner core before the remainder of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of said inner core, and   wherein at least one of said inner core, hollow flexible membrane and cover comprises an antimicrobial material.   
   
   
       39 . A one-way valve assembly and delivery system of  claim 38 , wherein said antimicrobial material is selected from one of silver ions contained within a ceramic carrier and sustained-release ionic silver compounds. 
   
   
       40 . A continuously sealing one way valve assembly and delivery system for dispensing a flowable substance, comprising:
 a source for storage of the flowable substance, the source having an opening;   a valve assembly coupled to the opening of the source, said valve assembly including
 (i) an inner core having an inlet opening for receiving the flowable substance into a passageway and at least one port opening from the passageway, 
 (ii) a hollow flexible membrane having a first end and a second end, the first end being thicker than the second end, wherein the hollow flexible membrane is fitted over an outer surface of the inner core and when the flowable substance is placed under pressure the flowable substance exits through the at least one port opening and expands said membrane outwardly from said outer surface of said inner core; 
   a cover enclosing the flexible membrane and having an outlet orifice for dispensing the flowable substance from the valve assembly when pressure is applied to the flowable substance and   wherein when the pressure on the flowable substance is released, the first end of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of the inner core before the remainder of the hollow flexible membrane moves back into tightly fitting contact with the outer surface of said inner core, and   wherein at least one of said hollow flexible membrane and cover comprises a hydrophobic material.   
   
   
       41 . A one-way valve assembly and delivery system of  claim 40 , wherein said hydrophobic material is selected from one of positively charged material, low friction material, high surface tension material, or anti-wetting material. 
   
   
       42 . A one-way valve assembly and delivery system of  claim 41 , wherein said wherein said low friction material is Teflon.