Abstract: Nested piston apparatus is disclosed for making free pistons used to provide multi-chamber mixing and sequential delivery syringes within conventional syringe barrels. Each such syringe comprising one or more free pistons made according to the instant invention whereby syringe contents are selectively kept disparate until acted upon by forced displacement of an associated plunger rod. As well, nested piston apparatus is disclosed for using nested piston apparatus as multiple free pistons for making triple chamber syringes.

Abstract: Methods and apparatus for sterilizing and filling vessels which are kept in a sterile environment while being filled are capped before filling and immediately thereafter are ready to be displaced into a potentially contaminating environment while retaining a predetermined SAL are disclosed. Such vessels can be syringes use for dispensing Avastin or conventional syringes. Also method and apparatus for making an eye drop bottle using a conventional medical syringe which can be used in kits made according to the present invention are disclosed. In addition, a method for modifying conventional eye drop bottles for use in kits made according to the instant invention is disclosed. Further, a method for linking single convenience kits to form increased numbers of vessels filled by the same single act, used to fill a single convenience kit, is also disclosed.

Abstract: Methods for providing a plurality of convenience kits for sterilizing and delivering a quantity of medicine into the safety of a sterile chamber inside closed system (which can be disposed in a potentially contaminating field environment) are disclosed for container filling applications including Avastin. fortified antibiotic eye drops, mitomycin and hazardous drugs, in general. The containers can include medical syringes, eye drop bottles, vials and product quality assurance containers. A syringe needle cap effective in containment of fluids dispensed from a syringe while being primed is also disclosed.

Abstract: Method and apparatus are disclosed for capping a plurality of bottles enclosed and sealed in a plastic bag. The method comprises disposing the plurality of bottles in a tray in a predetermined array such that caps, disposed in a plate can be displaced for convenient capping in a single step. Ratchet tools are disclosed for facile threading of caps to bottles.

Abstract: Method and apparatus are disclosed for capping a plurality of bottles enclosed and sealed in a plastic bag. The method comprises disposing the plurality of bottles in a tray in a predetermined array such that caps, disposed in a plate can be displaced for convenient capping in a single step. Ratchet tools are disclosed for facile threading of caps to bottles.

Abstract: Methods and apparatus for preparing autologous blood serum eye drops within a potentially contaminating environment are disclosed. Key convenience kit apparatus providing novel methodology includes a plastic bag in which an innovative tray securely holds a plurality of empty eye drop bottles and associated caps disposed and sealed therein. Providing the only access pathway into the bag is a sterilizing filter appliance which filters all fluid entering the bag and provides a nozzle for dispensing into bottles disposed in the tray. The key convenience kit apparatus is sterilized prior to use, assuring all components disposed within the bag are within a desired sterility assurance level. The sterilized state of items associated with the key apparatus is maintained by the single pathway for fluid. Capping and sealing the bottles before opening the bag permits delivery of sterile product for use outside the bag.

Abstract: Methods and apparatus for preparing autologous blood serum eye drops within a potentially contaminating environment are disclosed. Key convenience kit apparatus providing novel methodology includes a plastic bag in which an innovative tray securely holds a plurality of empty eye drop bottles and associated caps disposed and sealed therein. Providing the only access pathway into the bag is a sterilizing filter appliance which filters all fluid entering the bag and provides a nozzle for dispensing into bottles disposed in the tray. The key convenience kit apparatus is sterilized prior to use, assuring all components disposed within the bag are within a desired sterility assurance level. The sterilized state of items associated with the key apparatus is maintained by the single pathway for fluid. Capping and sealing the bottles before opening the bag permits delivery of sterile product for use outside the bag.

Abstract: A convenience kit for sterilizing and delivering liquids into the safety of a sterile environment inside a plastic bag (which can be disposed in a field environment) wherein a so sterilized liquid is dispensed into a vessel which is capped and sealed before removal from the bag. The convenience kit can be provided in a solitary format or, as a subkit combined with other associated items in a more inclusive convenience kit. In short, convenience kits made according to the present invention provide opportunity for accomplishing an aseptic liquid sterilizing transfer, a task which is commonly associated with on-hand capability of a laminar flow hood, in field environments and other areas which are remote from facilities having laminar flow hoods.

Abstract: A convenience kit for sterilizing and delivering liquids into the safety of a sterile environment inside a plastic bag (which can be disposed in a field environment) wherein a so sterilized liquid is dispensed into a vessel which is capped and sealed before removal from the bag. The convenience kit can be provided in a solitary format or, as a subkit combined with other associated items in a more inclusive convenience kit. In short, convenience kits made according to the present invention provide opportunity for accomplishing an aseptic liquid sterilizing transfer, a task which is commonly associated with on-hand capability of a laminar flow hood, in field environments and other areas which are remote from facilities having laminar flow hoods.

Abstract: A convenience kit for sterilizing and delivering liquids into the safety of a sterile environment inside a plastic bag (which can be disposed in a field environment) wherein a so sterilized liquid is dispensed into a vessel which is capped and sealed before removal from the bag. The convenience kit can be provided in a solitary format or, as a subkit combined with other associated items in a more inclusive convenience kit. In short, convenience kits made according to the present invention provide opportunity for accomplishing an aseptic liquid sterilizing transfer, a task which is commonly associated with on-hand capability of a laminar flow hood, in field environments and other areas which are remote from facilities having laminar flow hoods.

Abstract: Two embodiments of a normally closed asymmetric tapered fitting valve are disclosed. Each tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a correspondingly sized female tapered fitting. Use of the valve specifically targets use with medical luer fittings, but is not limited thereto. The preferred embodiment of an actuator portion of the valve has dimensions which are identical those of a female tapered fitting into which the valve is inserted to open. The valve opens by compressing a slit which is disposed along a major axis of the asymmetric valve as it is advanced through a tapered circular duct. The valve has back-to-back closure features which maintain the valve closed when not inserted. A stand-alone male adapter comprising the tapered fitting valve is disclosed.

Abstract: A plurality of embodiments of mixing syringes are provided. Inventive key to all of the embodiments is a piston valve which divides a barrel to create a pair of chambers in which matter and liquid can be disparately and securely disposed before mixing. Each disclosed piston valve is actuated by force on an associated plunger rod which produces pressure within an associated syringe resulting in a change of the valve state from closed to open. In addition, each such valve comprises check valve action which is permissive to only distal flow through the syringe. Embodiments for both a basic mixing syringe and a mixing syringe with flush are disclosed. Considerations and methods for chamber filling without valve actuation are provided. A mixing syringe system with flush system utilizing a dual chamber syringe having a male luer fitting and a separate diluent containing vessel having a female luer fitting is also disclosed.

Abstract: A dual-chamber syringe system is disclosed. Critical system oriented elements are disclosed, including plunger valve designs for accurate measurement and true, non-canting displacement; tamper and inadvertent valve actuation indicators, as well as, valve status indicators; anti-reflux construction; novel indicia patterns for dual-chamber syringe operation; structure and method for quality assurance that no gas can be delivered from a proximal chamber of the dual-chamber syringe and a kit for single step dose transfer. In addition, a tapered fitting valve is disclosed. The tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a tapered fitting. The preferred embodiment of an actuator portion of the valve is elliptical in shape.

Abstract: A dual-chamber syringe system is disclosed. Critical system oriented elements are disclosed, including plunger valve designs for accurate measurement and true, non-canting displacement; tamper and inadvertent valve actuation indicators, as well as, valve status indicators; anti-reflux construction; novel indicia patterns for dual-chamber syringe operation; structure and method for quality assurance that no gas can be delivered from a proximal chamber of the dual-chamber syringe and a kit for single step dose transfer. In addition, a tapered fitting valve is disclosed. The tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a tapered fitting. The preferred embodiment of an actuator portion of the valve is elliptical in shape.

Abstract: A plurality of embodiments of mixing syringes are provided. Inventive key to all of the embodiments is a piston valve which divides a barrel to create a pair of chambers in which matter and liquid can be disparately and securely disposed before mixing. Each disclosed piston valve is actuated by force on an associated plunger rod which produces pressure within an associated syringe resulting in a change of the valve state from closed to open. In addition, each such valve comprises check valve action which is permissive to only distal flow through the syringe. Embodiments for both a basic mixing syringe and a mixing syringe with flush are disclosed. Considerations and methods for chamber filling without valve actuation are provided. A mixing syringe system with flush system utilizing a dual chamber syringe having a male luer fitting and a separate diluent containing vessel having a female luer fitting is also disclosed.

Abstract: Two embodiments of a normally closed asymmetric tapered fitting valve are disclosed. Each tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a correspondingly sized female tapered fitting. Use of the valve specifically targets use with medical luer fittings, but is not limited thereto. The preferred embodiment of an actuator portion of the valve has dimensions which are identical those of a female tapered fitting into which the valve is inserted to open. The valve opens by compressing a slit which is disposed along a major axis of the asymmetric valve as it is advanced through a tapered circular duct. The valve has back-to-back closure features which maintain the valve closed when not inserted. A stand-alone male adapter comprising the tapered fitting valve is disclosed.

Abstract: A convenience kit which is usable in an ambulatory environment for bagged products which have exposed and potentially contaminated sharps as an end product. Preferred use focus of the kit is for bagged syringes. The kit provides accessible sections for accessing the unused bagged parts and for storing excess parts once a bag is opened. A removable protective cover is provided for the unused product storage. A single step used parts disposal system comprises an elongated orifice and a pair of opposing chutes which are constructed to provide a one-way path into a containment compartment which is expanded in volume as new products are removed. As the kit may be used in an ambulatory environment permissive to rotational and vibratory forces, the upper chute is pivotally affixed to rotate and close the elongated orifice by the same forces which urge products within the compartment toward the orifice.

Abstract: Two embodiments of a normally closed tapered fitting valve are disclosed. Each tapered fitting valve comprises a single molded incompressible, but supple part and a skeletal support whereby the tapered fitting valve is opened by insertion into a female tapered fitting. Use of the valve specifically targets use with medical luer fittings. The preferred embodiment of an actuator portion of the valve is preferably elliptical in shape. The valve opens by compressing a slit which is disposed along a major elliptical axis as it is advanced through a tapered circular duct. A stand-alone male adapter comprising the tapered fitting valve is disclosed. Also, a syringe barrel comprising a skeletal support structure for a securely affixed valve to thereby provide a syringe barrel with an integrally affixed male adapter is disclosed.

Abstract: A self-closing twisted slit valve which is opened by compression inside a receiving tapered female orifice. For luer fittings, internal taper of a female luer fitting provides sufficient distortion of an asymmetrical valve to distort a closed, preferably planar slit to a patent fluid pathway. The slit may be opened by valve displacement into a female connector orifice or by being pierced by a blunt cannula. The valve may be effectively used for both needleless connectors and for needleless connector adapters.

Abstract: A self-closing slit valve which is opened by compression inside a receiving tapered female orifice. For luer fittings, internal taper of a female luer fitting provides sufficient distortion of an asymmetrical valve to distort a closed, preferably planar slit to a patent fluid pathway. The slit may be opened by valve displacement into a tapered female connector orifice or by being forced open by a blunt cannula. The valve may be effectively used as a valving part in needleless connector adapters. A special method for constructing the valve when imposed upon by restrictive tolerances of a luer fitting is also disclosed. Examples of uses of the self-closing valve in male luer needleless connector adapters and closed mixing systems and closed mixing systems with flush are also disclosed. An application providing a closed male luer adapter, a closed valved male luer replacement for a syringe is disclosed as well as applications associated with closed system mixing syringes.