Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
  • A61J1/10—Bag-type containers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1406—Septums, pierceable membranes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/1475—Inlet or outlet ports
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/18—Arrangements for indicating condition of container contents, e.g. sterile condition
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/01—General aspects dealing with the joint area or with the area to be joined
  • B29C66/05—Particular design of joint configurations
  • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
  • B29C66/11—Joint cross-sections comprising a single joint-segment, i.e. one of the parts to be joined comprising a single joint-segment in the joint cross-section
  • B29C66/112—Single lapped joints
  • B29C66/1122—Single lap to lap joints, i.e. overlap joints
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/01—General aspects dealing with the joint area or with the area to be joined
  • B29C66/05—Particular design of joint configurations
  • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
  • B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
  • B29C66/128—Stepped joint cross-sections
  • B29C66/1282—Stepped joint cross-sections comprising at least one overlap joint-segment
  • B29C66/12821—Stepped joint cross-sections comprising at least one overlap joint-segment comprising at least two overlap joint-segments
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/01—General aspects dealing with the joint area or with the area to be joined
  • B29C66/05—Particular design of joint configurations
  • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
  • B29C66/12—Joint cross-sections combining only two joint-segments; Tongue and groove joints; Tenon and mortise joints; Stepped joint cross-sections
  • B29C66/128—Stepped joint cross-sections
  • B29C66/1286—Stepped joint cross-sections comprising at least one bevelled joint-segment
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/01—General aspects dealing with the joint area or with the area to be joined
  • B29C66/05—Particular design of joint configurations
  • B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
  • B29C66/13—Single flanged joints; Fin-type joints; Single hem joints; Edge joints; Interpenetrating fingered joints; Other specific particular designs of joint cross-sections not provided for in groups B29C66/11 - B29C66/12
  • B29C66/131—Single flanged joints, i.e. one of the parts to be joined being rigid and flanged in the joint area
  • B29C66/1312—Single flange to flange joints, the parts to be joined being rigid
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
  • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
  • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
  • B29C66/532—Joining single elements to the wall of tubular articles, hollow articles or bars
  • B29C66/5326—Joining single elements to the wall of tubular articles, hollow articles or bars said single elements being substantially flat
  • B29C66/53261—Enclosing tubular articles between substantially flat elements
  • B29C66/53262—Enclosing spouts between the walls of bags, e.g. of medical bags
  • B29C66/53263—Enclosing spouts between the walls of bags, e.g. of medical bags said spouts comprising wings, e.g. said spouts being of ship-like or canoe-like form to avoid leaks in the corners
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
  • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
  • B29C66/53—Joining single elements to tubular articles, hollow articles or bars
  • B29C66/534—Joining single elements to open ends of tubular or hollow articles or to the ends of bars
  • B29C66/5344—Joining single elements to open ends of tubular or hollow articles or to the ends of bars said single elements being substantially annular, i.e. of finite length, e.g. joining flanges to tube ends
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/50—General aspects of joining tubular articles; General aspects of joining long products, i.e. bars or profiled elements; General aspects of joining single elements to tubular articles, hollow articles or bars; General aspects of joining several hollow-preforms to form hollow or tubular articles
  • B29C66/51—Joining tubular articles, profiled elements or bars; Joining single elements to tubular articles, hollow articles or bars; Joining several hollow-preforms to form hollow or tubular articles
  • B29C66/54—Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles
  • B29C66/542—Joining several hollow-preforms, e.g. half-shells, to form hollow articles, e.g. for making balls, containers; Joining several hollow-preforms, e.g. half-cylinders, to form tubular articles joining hollow covers or hollow bottoms to open ends of container bodies
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
  • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
  • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
  • B29C66/7234—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer
  • B29C66/72341—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer for gases
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
  • B29C66/72—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined
  • B29C66/723—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered
  • B29C66/7234—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer
  • B29C66/72343—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the structure of the material of the parts to be joined being multi-layered comprising a barrier layer for liquids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
  • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
  • A61J1/14—Details; Accessories therefor
  • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
  • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
  • A61J1/2006—Piercing means
  • A61J1/201—Piercing means having one piercing end
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/10—Tube connectors; Tube couplings
  • A61M39/16—Tube connectors; Tube couplings having provision for disinfection or sterilisation
  • A61M39/165—Shrouds or protectors for aseptically enclosing the connector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/08—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using ultrasonic vibrations
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
  • B29C65/02—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure
  • B29C65/14—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor by heating, with or without pressure using wave energy, i.e. electromagnetic radiation, or particle radiation
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/70—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material
  • B29C66/71—General aspects of processes or apparatus for joining preformed parts characterised by the composition, physical properties or the structure of the material of the parts to be joined; Joining with non-plastics material characterised by the composition of the plastics material of the parts to be joined
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
  • B29C66/00—General aspects of processes or apparatus for joining preformed parts
  • B29C66/80—General aspects of machine operations or constructions and parts thereof
  • B29C66/83—General aspects of machine operations or constructions and parts thereof characterised by the movement of the joining or pressing tools
  • B29C66/832—Reciprocating joining or pressing tools
  • B29C66/8322—Joining or pressing tools reciprocating along one axis
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
  • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
  • B29L2031/00—Other particular articles
  • B29L2031/712—Containers; Packaging elements or accessories, Packages
  • B29L2031/7148—Blood bags, medical bags

Definitions

• the present invention relates to the field of containers for holding medical fluids for administration to patients.
• medical fluids includes medical, biological and veterinary fluids.
• the "patients” could be humans, fish, animals, reptiles, amphibians, birds, etc.
• the present invention relates to flexible autoclavable intravenous (IV) fluid containers or bags and non-PVC polyolefin film for their construction.
• the invention provides long shelf life flexible IV fluid containers that have a low moisture vapor transmission rate and can be terminally sterilized using high temperature treatment, i.e., sterilized after filling to deactivate microorganisms inside the containers (e.g., autoclaving) .
• Polyvinyl Chloride is a standard, widely used plastic packaging material used to manufacture flexible containers (bags and pouches) for the administration of small volume parenterals (SVP), often referred to as mini-bags; large volume parenterals (LVP) ; and various enteral nutritional and liquid preparations. These containers are often utilized for patient hydration and/or to supply pharmaceutical preparations, medicines, vitamins, nutritionals , and the like.
• SVP small volume parenterals
• LVP large volume parenterals
• enteral nutritional and liquid preparations enteral nutritional and liquid preparations.
• PVC has proven to be advantageous because of its resistance to heat, which allows the containers to be terminally sterilized using high temperature treatment.
• PVC also has its shortcomings.
• PVC films in the thickness range needed to be acceptably flexible for IV fluid containers typically do not provide a high moisture vapor barrier (MVB) .
• the moisture vapor transmission rate (MVTR) of flexible PVC containers is so high that an overwrap is required to increase the shelf life of the fluids contained therein by providing improved moisture vapor barrier (MVB) properties, as compared to the MVB properties of PVC alone.
• an overwrap is used to contain any leakage and help the port system of the flexible containers to survive autoclaving (i.e., high temperature treatment) or shipping and handling damage.
• SVP packages or bags
• multiple SVP packages are placed into one overwrap package.
• the shelf life of the individual SVP packages contained therein is limited to approximately 30 days, because of the poor MVB properties of PVC.
• the SVP packages must be discarded approximately 30 days after the overwrap is opened.
• LVPs large volume parentals
• the overwrap represents added packaging cost and weight, contributes to environmental waste, and depletes petroleum and other resources.
• an intravenous medical fluid container must: 1) drain uniformly, preferably with a readable falling meniscus; 2) have minimal air volume so that patient air embolisms are not an issue; and 3) leave minimal residual volume upon draining so the patient accurately receives the prescribed amount of drug or fluid. Only if the container is flexible, can all of these objectives can be met simultaneously.
• a flexible container means a container that collapses upon draining, such as a bag for example.
• Rigid containers do not change shape substantially upon draining.
• Semi-rigid containers have substantially the same shape in a filled state and in a drained state, i.e., they may deform some while draining but do not permanently collapse without application of external forces when drained.
• Semi-rigid containers or plastic bottles also require significant amounts of included air or venting to drain properly.
• anyone who has poured milk from a semi-rigid plastic container or oil from a semi-rigid can will appreciate that semi-rigid containers tend to drain sporadically and often unpredictably unless properly vented.
• Access ports are commonly used in infusion solution containers to administer solutions to a patient, or to add medicaments or other solutions to the container prior to administration.
• Current solution containers typically may include a dedicated outlet port for solution administration to a patient and a dedicated inlet port for the addition of diluent or other ingredients to the container.
• the outlet port is intended to be coupled to an administrative set and is therefore commonly referred to as the administrative port, whereas the inlet port is designed to permit the injection of therapeutic agents and nutrients into the partially filled container and is sometimes identified as the additive port.
• Such a container may contain a partial filling of a sterile solution such as saline or dextrose to function as a diluent for the injected additive.
• the container may house the drug and the diluent can be added by injection into the container through the additive port.
• the diluted drug or nutrient is then administered to a patient by means of the administrative port and an administrative set that may be either directly or indirectly (i.e., through another solution set) coupled to the patient.
• Strict limits or tolerances are often imposed on the assay or concentration of the drug to be delivered. Meeting these limits, especially if the filled container is stored for an extended period of time, is difficult if the moisture barrier of the container is too high.
• an object of this invention is to provide an improved medical fluid container.
• Another object of the invention is to provide a port fill tube configuration that increases container sealing reliability, as well as the ease and efficiency of manufacture .
• a further object of the invention is to provide a container with container wall formed of a multiple layer polyolefin material selected so as to meet the demanding requirements for terminally sterilized IV containers.
• a further object of the invention is to provide a flexible container with a longitudinal side seam configuration that is more ergonomic for handling purposes, and reduces wrinkling and undesired material tacking or blocking.
• a further object of the invention is to provide an improved method of fabricating and filling medical fluid containers .
• a further object of the invention is to provide an improved method of packaging and storing medical fluid containers .
• a further object of the invention is to provide a container that weighs less than PVC but provides a better moisture vapor transmission rate.
• a container for medical fluids has a container body formed of a multiple layer polyolefin film and includes one or more fluid ports therein.
• the ports can include a fill tube and a port closure system for association with the fill tube to seal the port closed.
• the container body, fill tube, and port closure system is free of PVC and DEHP.
• a port closure system for use with a fluid container having fluid ports may include administrative and additive port closure assemblies.
• the administrative port closure assembly receives a piercing pin and includes an administrative housing which seals closed one fluid port.
• a sleeve extends from an interior surface past a base surface in the administrative housing. The sleeve has an upper portion and a lower portion, of differing diameters.
• a cap assembly mates with the administrative housing, sealing the interior surface of the administrative housing.
• a removable cap provides access to the interior surface.
• the additive port closure assembly receives a needle and includes a reseal housing which seals closed another fluid port.
• a cap assembly mates with the reseal housing, sealing an interior face of the reseal housing.
• a removable cap provides access to the interior face.
• a reseal element is mechanically retained, secured or captured between the reseal housing and cap assembly.
• the port housings and the fill tubes include various features which facilitate the reliable fabrication and use of the container.
• the fluid container includes a flexible elongated container body having a fluid reservoir formed therein surrounded by a container wall including a front portion and a back portion and one or more longitudinal side edges.
• the front and back portions are sealed together along an outer peripheral seam, which is adjacent to at least one of the longitudinal side edges, to define the fluid reservoir.
• the outer peripheral seam follows a concave path with respect to a longitudinal axis of the container, and can also curve inwardly with respect to one or more of the side edges.
• the side edges can be straight or curve inwardly toward the central axis of the container as well.
• the container with a concave curved side seam is easy to grasp and handle, resistant to interior and exterior wrinkling, and resistant to tacking or blocking of the film inside the container near the corners .
• FIG. 1 is a partial exploded perspective view of the port closure system of the present invention in use with a fluid container .
• FIG. 2 is a partial perspective view of the port closure system of the present invention in use with a fluid container, needle and piercing pin set .
• FIG. 3A is a partial sectional exploded view of the port closure system of the present invention in use with a fluid container .
• FIG. 3B is a partial sectional assembled view of the port closure system of the present invention in use with a fluid container .
• FIG. 4 is a sectional view of the additive port closure assembly of the present invention.
• FIG. 5 is a sectional view of the additive port closure assembly of the present invention in use with a needle.
• Fig. 6A is a side view of the cap assembly of the present invention .
• Fig. 6B is a perspective view of the cap assembly of the present invention.
• Fig. 6C is an enlarged partial sectional view of the notched portion of the cap assembly taken along line 6C-6C in
• FIG. 6B is a diagrammatic representation of FIG. 6B.
• Fig. 7 is a sectional view of the reseal element of the present invention.
• FIG. 8 is a perspective view of the reseal element of the present invention.
• Fig. 9 is a sectional view of the administrative port closure assembly of the present invention in use with a piercing pin set.
• Figs. 10 is a cross sectional view of one embodiment of the administrative port closure assembly of the present invention .
• FIGS. 11-15 are cross sectional views of additional administrative port closure assembly embodiments.
• FIGS. 16-17 are perspective views of additional port closure system embodiments.
• Fig. 18 is a cross sectional view similar to Fig. 4 of an alternative embodiment of the additive port closure assembly.
• Fig. 20 is an enlarged partial cross sectional view of the additive port closure assembly and shows the area encircled by the line 20-20 in Fig. 18. Fig. 20 is similar to
• Fig. 19 shows the same area after the cap assembly is joined to the reseal housing.
• Fig. 21 is a front plan view of a fill tube port according to one embodiment of the invention.
• Fig. 22 is a sectional view of the fill tube taken along line 22-22 in Fig. 21 and shows the non-circular transverse cross-section of the lower portion of the fill tube.
• Fig. 23 is a side elevation view of the fill tube of Fig.
• Fig. 24 is a longitudinal sectional view of the fill tube taken along line 22-22 in Fig. 21.
• FIG. 25 is a top plan view of a container according to one embodiment of the present invention.
• FIG. 25A is top plan view of a container according to another embodiment of the present invention.
• FIG. 25B is top plan view of a container according to another embodiment of the present invention.
• Fig. 26A-26C is a series of sectional views showing the tooling, film and the lower portion of the fill tube of Fig.
• FIG. 27 is an enlarged cross-sectional view of the container of the present invention taken along line 27-27 in
• Fig. 28 is a simplified schematic diagram that shows the composition of one embodiment a multilayer polyolefin film which can be used to form the front and back portions of the container wall.
• the flexible long shelf life autoclavable fluid container 12 has a container body 1 with a fluid reservoir 2 formed therein surrounded by a flexible container wall 3.
• the container wall 3 has a front portion 3A and a back portion 3B.
• the container body has at least one port 14, 16 formed therein. In one embodiment, such as shown in Figs. 1-3B, there are two ports 14, 16 located at the same end of the container 12, which has an elongated container body 1.
• a port closure system 10 is shown for use with a fluid container 12 which has a flexible container body 1 having at least one port 14, 16 therein.
• a pair of ports i.e., two ports
• Fluid ports 14, 16 include fill tubes 13, 15 respectively, which are elongated in one embodiment.
• the fill tubes 13, 15 can be substantially identical in one embodiment and each have a distal end 17, a proximal end 19 and a fluid passage 21 that extends from the proximal end 19 to the distal end 17.
• the fill tubes 13, 15 are attached to the container body 1 as described below so that the fluid passage 21 of the fill tube 13, 15 is in fluid communication with the fluid reservoir 2 in the interior of the container body 1.
• the fill tubes 13, 15 have a generally cylindrical upper portion 23 adjacent to the distal end 17 and a lower portion 25 adjacent to the proximal end 19.
• the upper portion 23 of the fill tube 13, 15 has a generally cylindrical cavity 27 formed therein for receiving one of the port closure assemblies described in greater detail herein.
• the upper portion 23 of the fill tube 13, 15 also includes an annular flange 29 that extends radially outward.
• the flange 29 helps protect the user's fingers from inadvertent contact with a needle, cannula or spike when accessing the ports 14, 16.
• the upper portion 23 of the fill tube 13, 15 has an outer surface 31 below the flange 29. [58]
• the outer surface 31 has at least one notch 33 formed thereon. In one embodiment, the outer surface 31 has a plurality of circumferentially spaced notches 33 formed thereon. In another embodiment, a pair of equally space opposing notches 33 is provided.
• the notch or notches 33 can be used to orient the fill tube 13, 15 for attachment to the container body 1.
• the notch or notches 33 can take on many possible configurations and shapes.
• the notch 33 has a flat bottom and extends longitudinally along the outer surface 31 of the fill tube 13, 15, it provides a useful place for the user to grasp and hold the fill tube 13, 15.
• the lower portion 25 of the elongated fill tube 13, 15 has a non-circular transverse cross-section for a substantial portion of its length.
• the non-circular cross-section is rhomboidal or semi-rhomoidal .
• the non-circular cross-section is selected from a group of shapes consisting of oval, semi-oval, elliptical, semi-elliptical, rhomboidal and semi-rhomboidal .
• the non-circular cross-section is defined by a first axis and a second axis transverse to the first axis.
• the first axis terminates at opposite ends that define the width of the lower portion 25 of the fill tube 13, 15.
• the second axis terminates at opposite ends that define the depth of the lower portion 25 of the fill tube 13, 15.
• the width of the lower portion 25 of the fill tube is greater than the depth, such that the first axis is a major axis and the second axis is a minor axis of the transverse cross-section of the lower portion 25 of the fill tube 13, 15.
• the notch or notches 33 on the upper portion 23 of the fill tube 13, 15 can be perpendicular to the first or major axis of the lower portion 25, so that automated equipment can easily orient the fill tube 13, 15 properly for attachment to the container body 1 as described below.
• the lower portion 25 of the fill tube 13, 15 has an outside radius Rl formed on the opposite ends of the major axis of the transverse cross-section.
• the radius Rl is approximately 0.005 to 0.015 inch.
• the radius Rl is approximately 0.005 to 0.010 inch.
• the radius Rl is approximately 0.008 inch.
• the radius Rl has been found to contribute to the strength and reliability of the fill tube/container body interface or heat seal weld. Improved material flow and fusion at the critical junction Y of the container back, container front and fill tube has been observed with the improved fill tube design.
• the lower portion 25 of the fill tube 13, 15 can have an outside radius R2 formed on at least one of the opposite ends of the minor axis of the transverse cross-section.
• an outside radius R2 of approximately 1/8 to H inch is formed on both of the opposite ends of the minor axis.
• the radius R2 is approximately 0.150 to 0.200 inch.
• the radius R2 is approximately 0.178 inches.
• the radius R2 provides a large, smooth area for heat sealing, adhesion or other attachment means and a light, uniform, unwrinkled stretch of the container body film over the lower portion 25 of the fill tube 13, 15 without over-stretching or over-thinning the container body film material.
• fill tubes 13, 15 having a lower portion 25 with a width of approximately H inch and a depth of about H inch have been found to provide acceptable filling and draining characteristics.
• the fill tube 13, 15 is about 0.75 to two inches long.
• the length of the fill tube 13, 15 is about 1.4 to 1.8 inches.
• the fill tube 13, 15 is about 1.5 inches long. The relatively long fill tube lengths help to prevent a standard one inch or ⁇ ⁇ M inch long needle, spike or cannula from accidentally penetrating the container wall 3 of the container 12 or IV bag through the passage 21 of the fill tube 13, 15.
• the fill tube 13, 15 has a fill tube wall 35 that has sufficient thickness and rigidity to prevent an eighteen gauge needle from being pushed through the wall 35 on a path P that is perpendicular to the wall 35 when a force of three to six lbs. is applied.
• the fill tube wall 35 has a substantially uniform thickness of between about 0.9 and 1.5 mm.
• the wall 35 is approximately 1.2 mm.
• the rigidity of the wall 35 is derived from its material, which is described in greater detail below. Table 1 below is a comparison of the force required to puncture the fill tube wall with an eighteen gauge needle perpendicular to the surface for the present invention and commercially available IV bags or flexible containers.
• the ports 14, 16 are connected by a body portion 124 that comprises a flexible web of top and bottom sheets of multilayer film extending transversely across and sealed by heat welding or other means to each other and to the fill tubes 13, 15.
• the fill tubes 13, 15 of the ports 14, 16 can be independently moved or manipulated.
• the lower portion 25 of each of the fill tubes 13, 15 is attached to the container body 1 and the fill tubes 13, 15 are spaced apart sufficiently for a user to insert at least one finger therebetween ("fingers" as used herein can include a thumb) .
• the port closure system 10 includes two port closure assemblies; with the first port assembly being an additive port closure assembly 22 adapted to provide needle 18 sterile access to the first fluid port 14.
• the additive port closure assembly 22 is adapted to be assembled and sterilized as a subassembly prior to association and use with the fluid container 12.
• a sealed opening 42 is provided in cap assembly 38, and a removable cap 44 provides access to the sealed opening 42 and the interior face 28.
• the additive port closure assembly 22 need not be re-sterilized, as the cap assembly 38 operates as a sterile barrier to shield the interior face 28 from potential contamination.
• Removable cap 44 is tamper evident as it cannot be reconnected once removed. Furthermore, if the cap 44 is pierced while still in place, it clearly shows that a hole has been made in the cap (i.e., tampering has taken place) .
• the cap assembly 38 is of unitary construction and includes a crown 46 connected to the removable cap 44 by an annular frangible area 48.
• frangible area refers to any breakable area or any area with some form of breakable seal.
• the crown 46 of the cap assembly 38 has an outer shell 50.
• the sealed opening 42 extends between the outer and under shells 50 and 40 and provides access to the interior face 28 when the removable cap 44 is detached.
• a retaining rim 54 extends from the under shell 40 and around the sealed opening 42.
• a crown flange 56 extends generally radially from the sealed opening 42. The crown flange 56 protects the user from accidental pricks when applying needle 18 to the additive port closure assembly 22.
• a notch area 58 is formed on the cap assembly 38 and is operatively associated with the frangible area 48 to weaken the frangible area 48 near the notch area 58.
• the notch area 58 can be on the removable cap 44, as shown in Fig. 6C, or on the crown 46 without detracting from the invention.
• the notch area 58 can be formed in a variety of force focusing shapes, including but not limited to a partial pyramid shape, a V-shape, or a partial conical shape.
• a cover 60 of the removable cap 44 is sealed over the sealed opening 42 by the frangible area 48.
• the cover 60 has a thickness sufficient to resist manual piercing by needle 18 or piercing pin 20.
• the cover 60 Due to the melt temperature of the material of the cover 60 being in the range of 129 - 144 0 C and the presence of an air chamber under the cover once assembled, the cover 60 is adapted to shape changes during heat sterilization, which allows a user to discern the sterilized state of the additive port closure assembly 22 due to the shape of cover 60.
• a pull element 62 of the removable cap 44 is connected to the cover 60 to allow a user to manually tug on the pull element 62 to sever the frangible area 48 and separate the cover 60 from the crown 46.
• the pull element 62 includes a lever 64 connected to one side of the cover and adjacent to the crown 46.
• the lever 64 is positioned adjacent the notch area 58 and focuses the user tugging force on the pull element 62 at the notch area 58.
• the lever 64 includes an area of narrowed cross section that defines a pull force concentrator.
• the pull force concentrator is adjacent the frangible area 48 and near the notch area 58.
• the pull force concentrator is defined by a transverse groove 65 having rounded side walls in the top of the lever 64, although other shapes, orientations and locations will not detract from the invention so long as the structure focuses or concentrates the user tugging force on the pull element at the notch area 58.
• a pull tab 66 is connected to the lever 64 by a pull ring 68 and positioned opposite the lever 64 on the pull ring 68. The pull tab 66 provides an area for a user to manually grip and tug on the pull element 62.
• a reseal element 72 of the removable cap 44 is positioned between the under shell 40 of the crown 46 and the interior face 28 of the reseal housing 24.
• the reseal element 72 has an annular shoulder 74 extending radially from a central core 76.
• the annular shoulder 74 splits the central core 76 into an upper core 78 having a raised surface 80 and a lower core 82.
• the raised surface 80 extends beyond the sealed opening 42 in the cap assembly 38 when the removable cap 44 is detached.
• the exposed raised surface 80 provides a convenient swabbable area to sterilize during subsequent uses.
• the lower core 82 is received within the open cylinder 30 of the reseal housing 24.
• the diameter of the lower core 82 is selected relative to the diameter of the open cylinder 30 such that the open cylinder 30 presses radially inward on the lower core 82 to provide a seal therebetween and to re-seal the reseal element 72 itself when punctured.
• the lower core 82 is frictionally fitted or forcibly pressed into the open cylinder 30 of the reseal housing 24. This frictional fit provides one means of securing or retaining the reseal element 72 in the reseal housing 24 for subsequent assembly operations.
• An annular lip element 84 is connected to an outer rim 86 of the annular shoulder 74.
• the junction of the rim 86 and the lip element 84 has a fillet or inside radius 85.
• the lip element 84 extends transversely to the annular shoulder 74 in two directions.
• the upper and lower inside edges of the lip element 84 have a chamfer, inside radius or fillet 87 thereon to assist in molding and guide the retaining rim 54 or rim 32 toward the annular shoulder 74.
• the annular lip element 84 has an inside diameter greater than the outside diameter of the retaining rim 54 and an outside diameter less than the outer diameter of the crown flange 56.
• the rims 32, 54 abut or contact the lower surface and upper surface respectively of the annular shoulder 74.
• the cap assembly 38 provides a removable cap 44 that seals the reseal element 72 from contamination until use.
• an administrative port closure assembly 88 is shown as the second port closure assembly of the port closure system 10.
• the administrative port closure assembly 88 is adapted to provide piercing pin set 20 sterile access to the second fluid port 16.
• the administrative port closure assembly 88 is also adapted to be assembled and sterilized as a subassembly prior to association and use with the fluid container 12. [81] With reference to Figs. 1, 9 and 10, the administrative port closure assembly 88 includes a second port housing 90 (hereinafter "administrative housing 90") adapted to seal closed the second fluid port 16 by attachment to the fill tube
• a base surface 92 is adapted to be associated with the second fluid port 16 or fill tube 15 and an interior surface 94 is adapted to face outwardly from the second fluid port 16.
• a seal ring 95 extends from the base surface 92 and is adapted to be sealably received within the second fluid port
• the seal ring 95 has a stiff construction and large diameter of about 5/8" to provide improved user handling of administrative port closure assembly 88.
• An optional stiffening hoop or rib 97 more preferably a pair of spaced ribs 97, extends radially inwardly on the seal ring 95 to stiffen the seal ring and resist deformation during heat sealing to the port 16 and later autoclave heat sterilization.
• a sleeve 96 extends from the interior surface 94 past the base surface 92 and within the seal ring 95. The sleeve 96 is recessed below sealed opening 42 of second cap assembly 38 connected to the administrative housing 90.
• the upper portion 98 has a substantially uniform wall thickness and is tapered inwardly into a bullet nose configuration where the exterior surface is convex and the interior surface is concave.
• the taper can be formed by any number of well-known manufacturing techniques, including but not limited to cutting, rolling (with or without heat) and swaging.
• the taper of the upper portion 98 is preferably curvilinear, but linear taper can also be used. During use the user's fingers are within W of the sleeve 96, allowing the user to easily control the position of the sleeve 96 with respect to piercing pin sets 20.
• the sleeve 96 and the seal ring 95 are connected at a flexible annular junction 102 at a base 114 for the sleeve to form a unitary body.
• the flexible junction 102 allows for some minor displacement of the sleeve 96 with respect to the rigid seal ring 95 during use.
• An air-filled moat 106 is positioned between the seal ring 95 and the sleeve 96 on the base surface 92.
• the moat 106 allows the seal ring 95 to contract and expand as needed based on internal pressure of the container 12 during the heat sterilization cycle.
• the moat 106 protects the sleeve 96 from significant permanent deformation that could lead to leaks or unacceptable insertion or withdrawal force requirements.
• the connection between the seal ring 95 and sleeve 96 provides a clamping or sealing force on piercing pin set 20 (not shown) during pin insertion and withdrawal.
• the sleeve 96 is protected by the seal ring 95 and moat 106 from potential distortion during autoclaving, since the moat 106 reduces outside pressure against sleeve 96 during autoclaving.
• An administrative diaphragm 110 is connected to the sleeve 96 to seal the sleeve 96 closed to fluid flow.
• the administrative diaphragm 110 is opened to fluid flow once pierced by piercing pin set 20.
• An administrative flange 112 extends generally radially from the seal ring 95, and thus from the sleeve 96.
• the administrative flange 112 around the sleeve 96 creates an effective target area for the user to apply the piercing pin set 20 toward and protects the user from accidental pricks.
• a second cap assembly 38 is connected to the administrative housing 90 to form the administrative port closure assembly 88.
• the under shell 40 is shaped to mate with the interior surface 94 of the administrative housing 90. Once mated, the cap assembly 38 seals the interior surface 94 from potential contamination.
• the removable cap 44 provides access to the sealed opening 42 and thus the interior surface 94.
• the administrative port closure assembly 88 need not be re-sterilized, as the cap assembly 38 operates as a sterile barrier to shield the interior surface 94 from potential contamination.
• port housings 24/90, cap assembly 38 and reseal element 72 are mold formed.
• the additive port closure assembly 22 is formed by positioning reseal element 72 between the cap assembly 38 to the port housing 24, and permanently connecting the cap assembly 38 to the port housing 24.
• the administrative port closure assembly 88 is formed by connecting the cap assembly 38 to the port housing 90.
• Port closure assemblies 22/88 are connected together by ultrasonically welding or radiant thermofusion welding the cap assembly 38 to the port housing 24/90.
• Port closure assemblies 22/88 are sterilized by irradiation.
• the irradiated pre-sterilized port closure assemblies 22/88 form subassemblies that are subsequently associated with or attached to the fluid container 12.
• the fluid container 12 is sealed to the irradiated port closure assemblies 22/88 by conventional means, including but not limited to ultrasonically welding, radiant thermofusion welding, or hot tongue heat sealing.
• the associated port closure assemblies 22/88 and fluid container 12 are then terminally heat sterilized by autoclaving after filling.
• Port closure assemblies 22/88 are formed of a polymer blend that does not degrade during the irradiation, sterilization, radiant thermofusion welding, and ultrasonic welding.
• degrade refers to degradation to such an extent that the material is no longer suitable for its intended purpose.
• the polymer blend also provides ultrasonic sealability, radiant thermofusion sealability, and prevents coring when the polymer is punctured.
• coring refers to the process of a polymer fragmenting upon piercing so as to result in the formation of loose polymer particulate.
• polymer blend to be sealed by ultrasonic bonding and/or radiant thermofusion eliminates the need for any solvent or swaged bonding; and also eliminates the need to provide additional frictional force fit components to hold the port closure system 10 together. Additionally, the polymer blend provides a balance between insertion and withdrawal forces for improved handling by users.
• polystyrene resin includes but is not limited to a blend of 70% commercially available Atofina Z9470 and 30% commercially available Basell KS359P.
• Other suitable polypropylene copolymers and polyethylene copolymer blend could also be used without departing from the present invention .
• the fill tube 13, 15 is formed of a material that is sealable to the inner sealant surface of the IV fluid container 12 and the port housings 24, 90. It must be able to be autoclaved without deformation that significantly affects its appearance or function of providing a channel between the container 12 and the ports 14, 16.
• the fill tube 13, 15 preferably comprises a polypropylene homopolymer or copolymer.
• a homopolymer provides better dimensional stability through autoclaving, while a copolymer provides better compatibility with an IV container 12 that has a copolymer sealant surface.
• the fill tube 13, 15 preferably comprises a random polypropylene copolymer with ethylene content from about 2% to about 6% and a melting point from about 129°C to about 145°C.
• the random polypropylene copolymer more preferably has an ethylene content of about 2.4-3.5% and a melting point of about 145°C.
• a random polypropylene copolymer has been found to produce the best results at autoclave temperatures up to about 125 0 C with a container 12 with polypropylene copolymer sealant layer and port housings 24, 90 comprising a blend of polypropylene copolymers.
• the administrative port housing 90 must be heat sealable to both the fill tube 13 and cap assembly 38, as well as be stable to gamma radiation from 18-45 kGy, or at least 18-32 kGy.
• the administrative port housing 90 must be autoclavable up to about 125°C without deformation that significantly affects its function of being able to accept and retain a piercing pin 20 with acceptable forces.
• the material selected for the administrative port housing 90 has a high melt temperature and good elastomeric properties .
• a material blend is preferred to provide properties not available from individual materials.
• a polypropylene based material is preferred primarily for its chemical compatibility with the polypropylene fill tube 13.
• a high ethylene content random copolymer is used as the base material.
• the high ethylene content improves radiation stability and lowers the modulus while maintaining acceptable resistance to autoclave deformation. It also reduces the concentration of the softening material required.
• softening material often has a lower melting point or is tacky and difficult to injection mold.
• a high ethylene content random polypropylene copolymer such as Total Petrochemicals Z9470, is used for the base material.
• an unmodified high ethylene content random polypropylene copolymer may provide acceptable performance with a single piercing pin diameter
• it is preferable to soften the material with polypolyolefin copolymers such as thermoplastic polypolyolefin elastomers (TPEs) or plastomers to broaden the range of acceptable piercing pin diameters and improve radiation stability.
• Acceptable performance also may be obtained with low ethylene content polypropylene random copolymer base materials with an appropriate selection of TPE/plastomer and blend ratio. Similar to polypropylene copolymers, softer TPEs and plastomers generally have lower melting points.
• Ethylene-hexene and ethylene-octene copolymer flexomers or plastomers have very low moduli and melting points (72°C and 55°C, respectively) substantially below the autoclave temperature of 125°C.
• a low ethylene content random copolymer at a ratio of 70% polypropylene copolymer/30% flexomer or plastomer, they provide adequate softening and autoclave dimensional stability.
• An ethylene-octene flexomer or plastomer, such as Dow Affinity EG8100, can be used to reduce piercing pin insertion force.
• the port cap assembly 38 must be sealable to both the administrative and additive port housings 90, 24 and stable to gamma radiation from 18-45 kGy, or at least 18-32 kGy. It must be autoclavable up to about 125°C without deformation that significantly affects its function of maintaining sterility and being opened with an acceptable pull force. Key to an acceptable opening performance is developing an appropriate combination of material stiffness and tear detail thickness.
• the pull ring 68 or pull element 62 may snap off prior to opening the cap 44 with an excessively stiff material or thick tear detail.
• the pull ring 68 may stretch without opening the cap 44 or the cap 44 may deform during autoclaving with a material that is too soft.
• the range may be adjusted depending upon diaphragm thickness, with thicker diaphragms generally requiring a higher elastomeric concentration.
• the blend of resins used for the various parts to be sonic or heat welded must provide melting points that are not so dissimilar as to prevent proper sealing security or reliability.
• a still further embodiment of administrative port closure assembly 88 includes some of the features of the embodiment of Figs. 9-11 but further includes a pre-pierced administrative seal washer 118 having a wiping diameter 119, retained, secured, held, or more particularly (especially once heat sterilized) clamped in place between the retaining rim 54 and an administrative rim 120 extending from shoulder 102.
• the administrative seal washer 118 seals against piercing pin set 20 (not shown) .
• the wiping diameter 119 can be centrally located and the pre-pierced diameter can be gradually increased as distance from the wiping diameter increases.
• a still further embodiment of administrative port closure assembly 88 includes some of the features of the embodiment of Fig. 12 but includes an administrative reseal 118A similar to the reseal element 72 of the additive port closure assembly 22, retained, secured, held, or more particularly clamped in place between the retaining rim 54 and an administrative rim 120 extending from shoulder 102. Similar to the reseal element in the additive port closure assembly 22, the administrative reseal 118A is clamped by the rims 54 and 120, especially once the assembly 88 is heat sterilized. The administrative reseal 118A seals against piercing pin set 20 (not shown) .
• the diaphragm 110 is optionally excludable in this embodiment.
• the central diaphragm 121 of the reseal 118A is relatively thick (greater than 0.050 inch or 1.27 mm) in the embodiment of Fig. 13.
• a still further embodiment can combine the features of Figs. 12 and 13 so that the reseal element 118A includes a thin (0.010-0.050 inch or 0.254-1.27 mm) central diaphragm 121 rather than a pre-pierced opening or wiping diameter 119 or the thick central diaphragm 121 of at least .050 inch or 1.27 mm shown in Fig.
• a still further embodiment of administrative port closure assembly 88 includes a small wiper 116 similar to the embodiment of Fig. 11, but the wiper 116 and sleeve 96 form a unitary body that is molded through co- injection molding so that small wiper 116 has a different polymer content than sleeve 96.
• the wiper 116 is formed of isoprene and will generate holding forces during activation with the piercing pin set 20 (not shown) .
• FIG. 16 Another embodiment of port closure system 10 replaces cap assemblies 38 with cover foils 122.
• the cover foils 122 are made of pealable film stock.
• reseal element 72 is swaged in place.
• a body portion 124 joins the administrative port assembly 88 and additive port assembly 22.
• a further embodiment of port closure system 10 includes the same features as the embodiment of Fig. 16, and further includes a handle element 126 joining the port assemblies 22, 88 so as to define a space 127 between the handle portion 126 and the fluid container 12, thus permitting a user to loop fingers around handle portion 126. Additionally, additive port assembly 22 is sized smaller than administrative port assembly 88 and is positioned lower with respect to the administrative port assembly 88, to further distinguish the additive port assembly 22 from the administrative port assembly 88. [106] With reference to Figs. 18-20, a further embodiment of the additive port closure assembly 22 includes a reseal housing 24 and reseal element 72 as described above.
• the sealing element 150 can take various forms and shapes, in the embodiment shown, the sealing element 150 includes at least one protrusion 152 that extends downwardly from the under shell 4OA and defines 154, 156 troughs on either side thereof.
• the protrusion 152 can be generally V- shaped in cross section and have angled sides 158, 160 that converge to form a blunt, rounded tip 162.
• the protrusion 152 extends around the under shell 4OA in a circular pattern. The circular pattern can be broken to form circumferentially spaced protrusions or can be unbroken to form a continuous annular protrusion.
• the sealing element 150 can include a plurality of concentrically arranged protrusions 152.
• the sealing element 150 engages the lip 84 between the under shell 4OA and the interior or inner surface 28 when the under shell 4OA of the crown 46 is connected, attached or joined to the inner surface 28 of the reseal housing 24 as described above.
• the tip 162 and angled sides 158, 160 of the protrusion 152 or sealing element 150 contact and sealingly engage the top surface 89 of the lip 84.
• the reseal element 72 resiliently deforms around the protrusion 152.
• the engagement of the protrusion 152 with the resilient reseal element 72 provides a clamping force on the lip 84, clamping it between the protrusion 152 on the under shell 4 OA and the inner surface 28 of the reseal housing 24.
• the sealing element 150 includes one or more protrusions 152 arranged a sufficiently closed annular pattern, this arrangement provides an effective seal against liquids, vapors and gases that might otherwise pass around the reseal element 72.
• the invention assists in preventing contamination from reaching the inner surface 28 when the user removes the detachable cap 44. Undesirable ingress and egress of liquids, vapors or gases is prevented during the sterilization of the port closure assembly 22 or the fluid container 12 to which the port closure assembly is attached.
• This embodiment of the invention provides the additional benefit of further restraining the reseal element 72 against movement that might otherwise occur during insertion or withdrawal of a needle 18 or similar piercing member.
• Figs. 18-20 can be applied alone or in combination with other features disclosed herein.
• the principles are applicable to administrative port closure assemblies that utilize a reseal element, such as the embodiment of Fig. 13.
• the port housings 24, 90 which are sealingly attached to the cap assembly 38 and fluidly seal the ports 14, 16 respectively in one embodiment by attachment to the flange 29 of the fill tube 13, 15, each can include additional beneficial features.
• the port housing 24, 90 has an undercut or annular recess 91 formed on an annular portion of the base face 26 or base surface 92 respectively.
• the annular portion of the base face 26 or base surface 92 also has a chamfered outer edge 93 and a contact ring 99 located between the annular recess 91 and the chamfered outer edge 93.
• the contact ring 99 is smooth, planar and substantially horizontal.
• the recessed, chamfered, and ringed configuration provides a good contact surface at the ring 99 for attaching the port housing 24, 90 to the cap assembly 38 by ultrasonic welding, and later for attaching the port closure system or assemblies 22, 88 to the fill tubes 13, 15 at the flange 29 by hot tongue welding or other means.
• the annular recess 91 and the chamfered outer edge 93 also help eliminate or redirect into harmless areas any flash from molding of the port housing 24, 90 or hot tongue welding.
• the container 12 includes a container body 1.
• the container body 1 has front and back portions 3A, 3B, which can be separate double wound sheets of flexible multiple layer polyolefin film sealed together by heat sealing or other means along an outer peripheral seam 5.
• the front and back portions 3A, 3B could be formed by folding a single sheet of film over upon itself.
• a conventional non-PVC polypolyolefin film commercially available from Sealed Air Corporation under the trade designation CRYOVAC M312 is used in the container 12 with the port closure system of the present invention.
• This material has been found to exhibit excellent compatibility with the non-PVC materials preferred for the fill tubes 13, 15 and port closure systems.
• each sheet of the CRYOVAC M312 material defining the front and back portion 3A, 3B has five layers.
• the first layer Ll which is also referred to herein as a sealant layer or the inner layer, is a polypropylene layer that is adapted to be heat sealed, welded or fused to itself using conventional attachment techniques, including but not limited to heat welding.
• the second layer L2 which is also referred to as a base, outer or release layer, is a polyester layer adapted to contact and release from the heat sealing tool.
• a polyethylene middle barrier layer L3 is disposed between the inner and outer layers Ll, L2.
• An inner tying layer L4 is located between the middle layer L3 and the inner layer Ll.
• An outer tying layer L5 is located between the middle layer L3 and the outer layer L2.
• the tying layers L4, L5 attach the first layer Ll and the second layer L2 respectively to the third or middle layer L3.
• Containers 12 filled with approximately 500 ml or 1000 ml of medical fluids, with the port closure system 10 described herein and a container wall 3 of CRYOVAC M312 film having an overall thickness of about 8 mils have been shown to provide a shelf life up to or greater than 24 months and a moisture vapor transmission rate (MVTR) of less than about 0.060 g/100 in 2 -day. On-going tests indicate that the shelf life might be extendable up to 36 months, dependent on acceptable fill volume and assay values for the product.
• Containers 12 of 500 ml or larger made of this film and the port closure system disclosed herein do not require supplemental moisture barriers or overwraps on the individual containers to achieve these results. As shown in Table 2 below, these containers 12 compare favorably in terms of MVTR to conventional containers constructed of monolayer PVC film.
• the polyolefin container 12 can be fabricated by taking double wound film from either a blown film or cast film process and feeding it into a bag fabricator as a continuous web.
• the containers 12 or bags are normally made side by side on the web of film with the fill ports 13, 15 protruding from one edge of the web.
• the film first has label copy applied to it via one or more conventional processes. Hot stamping, lithography, thermal transfer printing or a combination of these can be employed to place any necessary label information onto the container .
• the film is then opened and fill tubes 13, 15 are place between the two film sheets or front and back portions 3A, 3B as illustrated in Figs. 26A.
• the fill tubes 13, 15 are then heat sealed to the two sheets of film or the front and back portion 3A, 3B by a tool T.
• 3A, 3B creates the perimeter or outer peripheral seal 5, and separates the containers.
• the filled containers 12 are placed into an autoclave for steam heat sterilization to assure that the final product is sterile.
• the container contents are steam sterilized using a cycle of 121 + 4/- 0 degrees C with a peak dwell of 15 minutes for the coldest container.
• the flexible container or IV bag 12 of Fig. 25 has substantially straight longitudinal sides.
• the container has an outer peripheral seam 5 that joins together the front and back portions 3A, 3B of the container wall 3.
• the seam 5 can be formed by well known conventional processes, including but not limited to heat welding, ultrasonic welding, etc.
• the seam 5 or weld extends straight along the substantially straight longitudinal sides of the container body 1 and curves in a convex manner at the corners of the bag 12.
• changes in the path of the outer peripheral seam 5 of the container 12 near the corners can cause kinking, wrinkling and undesired tacking together of the material in the interior of the container near the corner when the bag 12 is filled.
• the tacking is especially evident after autoclaving, may detract from the clarity of the film, may adversely affect drainage, and may be perceived by users as a defect of the bag 12 or its contents.
• the present invention provides a solution to these problems by providing a flexible fluid container or bag 12, as exemplified in Figs. 25A, 25B and 27.
• the container or bag 12 has a flexible elongated container body 1. As seen in Fig. 27, the body 1 has a fluid reservoir 2 formed therein.
• the fluid reservoir 2 is surrounded by a container wall 3 that includes front and back portions 3A, 3B.
• both of the opposing longitudinal edges 37, 39 are straight and the seam 5 curves inwardly with respect to both of the opposing longitudinal edges 37, 39.
• the longitudinal side edges 37, 39 also curve inwardly.
• the side edges 37, 39 can vary in distance from or be parallel to the curved seam 5. The latter embodiment can be helpful in reducing the amount of material present in the finished container 1 without endangering the integrity and reliability of the welded seam 5.
• the front and back portions 3A, 3B can be formed in a variety of ways and from a variety of materials, including but not limited to the film can be the low MVTR polyolefin DEHP- free and PVC-free multiple layer film previously discussed in this application, without departing from the scope of this aspect of the invention.
• the front portion 3A and the back portion 3B can each be formed of a separate sheet of flexible film.
• the film of the front portion 3A can be identical from a materials standpoint to the film of the back portion 3B or differing films and/or materials can be used.
• the front portion 3A and the back portion 3B are formed from a unitary sheet of the film that is folded along the top, bottom or side to form the front portion 3A and the back portion 3B. This positions the inner layer of the front portion 3A in facing or superimposed relation to the inner layer of the back portion 3B.
• the shape of the front portion 3A can also differ from the shape of the back portion 3B.
• the shape or shapes of the front and back portions 3A, 3B can be multilateral.
• the sheet or sheets of film that make up the front and back portions 3A, 3B cam be substantially rectangular.
• the container of the present invention with a curved side seam is easy to grasp and handle, resistant to interior and exterior wrinkling, and resistant to tacking or blocking of the film inside the container near the corners.
• the invention can be applied to flexible containers for enteral nutritional or other medical fluids as well.
• the invention provides a port closure system that reduces the possibilities of contamination during storage and use, improves the ease of handling when fluids are to be withdrawn or introduced, and increases the ease and efficiency of manufacture.
• the invention provides a container that is free of PVC and DEHP.
• the container has a low MVTR, which enables greater manufacturing tolerances around the target fill volume .

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• Health & Medical Sciences (AREA)
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• Pharmacology & Pharmacy (AREA)
• Life Sciences & Earth Sciences (AREA)
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• 2007
  • 2007-06-28 WO PCT/US2007/072361 patent/WO2008003045A2/en active Application Filing
  • 2007-06-28 EP EP07799133.9A patent/EP2037830A4/de not_active Withdrawn
  • 2007-06-28 JP JP2009518556A patent/JP2009542367A/ja active Pending
  • 2007-06-28 AU AU2007265010A patent/AU2007265010B2/en not_active Expired - Fee Related
  • 2007-06-28 CA CA002656488A patent/CA2656488A1/en not_active Abandoned

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