Abstract: A needleless luer access connector is disclosed having a septum disposed in a housing. The septum has a proximal portion with a cross section, a medial portion with a cross section smaller than the cross section of the proximal portion, and a distal portion. A longitudinal slit extends through the septum from the proximal portion to the distal portion. The septum and housing are designed so that septum will not be rotated or removed from the housing when the connector is accessed by a male luer taper. In addition, the septum and housing are designed to bias the slit at the distal portion closed and so a male luer connector does not have to extend completely through the distal portion to open the slit at the distal portion. Finally, the septum and housing are designed to minimize the amount of dead space in the connector when accessed with a male luer taper.

Abstract: A sealing component includes an elastomeric material. An exterior side surface of the elastomeric material is to define at least a first seal with a first external mating member into which the sealing component is insertable. An interior surface of the elastomeric material is to define a second seal and a third seal with a second external mating member insertable into the sealing component.

Abstract: Needleless access port valves are generally discussed herein with particular discussions extended to needleless access port valves comprising an inlet coupler. In accordance with aspects of the present invention, a coupler comprises an inlet and an outlet. The inlet is adapted to mate with a first medical implement and the outlet is adapted to mate with an inlet of a valve, which has an outlet adapted to mate with a second medical implement.

Abstract: A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, analgesics, and like medicinal agents from the device reservoir which is provided in the form of a novel bellows-type assembly. The fluid dispenser includes a unique stored energy mechanism which takes the form of a constant force spring member of novel design that provides the force necessary to continuously and substantially uniformly expel fluid from the device reservoir. The device also includes novel adjustable flow rate control assembly that is disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.

Abstract: A drug storage and delivery device (1) comprising a reservoir (2) containing a liquid, a vial (3) containing a dry drug, such as a lyophilized drug, means (6) for forcing the liquid from the reservoir (2) to the vial (3), via an established fluid connection, and locking means adapted to prevent the means (6) for establishing a fluid connection from re-establishing a previously disconnected fluid connection between the reservoir and the vial. Thereby the dry drug is reconstituted, and the forcing means (6) may subsequently be used for forcing reconstituted drug out of the device (1). The reservoir (2), the vial (3), the fluid connection and the forcing means (6) may form an at least substantially integral unit. This is an advantage because the number of steps needed to be performed by the user is reduced, the risk of contamination is reduced, the risk of incorrect reconstitution and dosage is reduced, and the device is easy to operate, e.g. using just one hand.

Abstract: The multiple medication IV pump provides automated intravenous delivery of one or more medications. A carousel assembly holds multiple medication vials, and a computerized control circuit operates the carousel to position a selected medication vial proximate to a spiking unit and mixing chamber to deliver the contents of the vial into an IV solution. The spiking unit and mixing chamber comprise a hollow chamber and a hollow spike, or needle, extending from the hollow chamber. The contents of a medication vial spiked onto the spiking unit flow into the mixing chamber. A fluid entry port located near the top of the mixing chamber is connected to a first pump such that a fluid may be pumped into the mixing chamber. A fluid exit port located near the bottom of the mixing chamber is connected to a second pump such that a fluid may be pumped out from the mixing chamber.

Abstract: A drug mixing and expelling device (1) for mixing a drug with a liquid, thereby forming a reconstituted liquid drug. The device comprises a reservoir (2) containing a liquid, a vial (4) containing a drug, a vial, means (5) for establishing a fluid connection between the reservoir and a vial positioned in the vial adapter (3), means (7, 8) for forcing the liquid from the reservoir to a vial, and means (9) for activating said forcing means during establishment of the fluid connection between the reservoir and the vial. The forcing of liquid into the vial provides a pressure therein, which can be used for infusion of the reconstituted drug directly from the vial. The device also comprises a suction unit (13) for aspiration.

Abstract: A compact fluid dispenser for use in controllably dispensing fluid medicaments, such as, antibiotics, analgesics, and like medicinal agents from the device reservoir which is provided in the form of a novel collapsible bottle-like assembly. The fluid dispenser includes a unique stored energy mechanism which takes the form of a spring member of novel design that provides the force necessary to continuously and substantially uniformly expel fluid from the device reservoir. The device also includes novel adjustable flow rate control assembly that is disposed intermediate the fluid reservoir outlet and the outlet port of the device for precisely controlling the rate of fluid flow from the outlet port toward the patient.

Abstract: This device comprises means for supporting a first and a second chamber, means for allowing these chambers to communicate with each other, and a movable member for applying a suitable force to reduce the volume of the first chamber. The means for supporting the first and second chambers comprise two tubular bodies, each open at one end, the dimensions of these openings being such as to allow these tubular bodies to be brought together and slid one into the other, a double-ended needle, with associated guide means, being interposed between the said chambers in such a way that when the said tubular bodies are slid towards each other, the respective ends of the said needle pass into the chambers and the volume of the chamber is reduced.

Abstract: An attachment arrangement has a housing and a needle located within the housing. The arrangement allows administration ports of different sizes to be inserted into and secured within the housing. In certain embodiments, compliant retainers secure the administration port within the housing. In certain other embodiments, the administration port is secured within the housing when the housing is compressed against the administration port by a housing compression element. Once the administration port is secured within the housing, a fluid-tight seal is formed between the attachment device and the administration port.

Abstract: A dispensing device for dispensing medicaments to a patient which includes a supporting structure; a carriage assembly interconnected with the supporting structure for movement between a first position and a second position and a semi-rigid, collapsible reservoir carried by the carriage assembly. A stored energy source is operably associated with the carriage assembly for moving the carriage assembly between the first and second positions. The device also includes novel structure, including fill-vials, for adding medicaments to the fluid within the fluid reservoir.

Abstract: A medical device has an interior for containment of fluids; an opening into the interior, and an elastomeric wall having at least one perforation. The wall comprises a fixedly placed, flexible barrier across the opening. The device also defines a passageway extending inwardly from adjacent to the elastomeric wall, the passageway being proportioned to receive and form an annular seal with a connector tube that extends into the interior through the perforation.

Abstract: The invention relates to an apparatus comprising a closure-cap and a container in the form of a two-chamber cartridge in which an active ingredient and a solvent can be stored separately until the apparatus is used in a nebulizer, as well as an active substance concentrate in which the active-substance is present as a solution or suspension for storage purposes.

Abstract: The invention relates to an apparatus comprising a closure-cap and a container in the form of a two-chamber cartridge in which an active ingredient and a solvent can be stored separately until the apparatus is used in a nebuliser, as well as an active substance concentrate in which the active substance is present as a solution or suspension for storage purposes.

Abstract: A multi-well assembly according to one embodiment comprises a multi-well block and a guide plate. The multi-well block defines a plurality of wells, with each well having a fluid-impermeable bottom surface. The guide plate defines a plurality of fluid passageways corresponding to the wells of the multi-well block. The guide plate is configured such that, whenever the guide plate is registered with the multi-well block, fluid communication is established between each well and an associated fluid passageway.

Abstract: A mixing/charging port for medical treatment in which no air bubble is retained inside thereof even at the time of priming, and which is capable of infusing a drug solution or transfusing blood into a patient safely.

Abstract: An implantable device for administering a treatment solution has a first chamber for accommodating the active solution to be administered and a second chamber for accommodating a treatment solution bolus, each chamber having a port sealed with a septum. An infusion line leading to the infusion site is connected to the outlet of the first chamber. An inlet line branches off from the infusion line and is connected to the second chamber to accommodate the active solution bolus, and includes a flow device which releases the flow path to the infusion site only when the active solution bolus is supplied at a pressure above a predetermined minimum pressure. The occurrence of life-threatening situations due to sudden administration of a large quantity of active solution is prevented if the active solution is always supplied only at a pressure below the minimum pressure at which the flow path is released.

Abstract: An intravenous drug access system. In one embodiment of the invention, the drug access system includes an IV bag having an inlet port and an outlet port, whereby the inlet port is a female luer integral therewith. The integral female luer fitting may be fitted with a sealed end cap including a male luer insert with a closed end. An alternative embodiment of the present invention comprises a discrete pre-molded connector made with a spike at one end and a female luer fitting at the opposing end. The spike is used to penetrate a standard IV bag through a conventional inlet port.

Abstract: A mixing/charging port for medical treatment capable of cleanly wiping out a residual liquid, residual blood, or the like. The mixing/charging port includes a disk-like valve having an insertion hole at the center, a seating for supporting a lower part of the periphery of the valve, and a cover for restraining the valve. A fitting hole defined by an inner edge portion of the cover works as an anchor for anchoring an insertion member to the mixing/charging port, the thickness of the center of the valve is larger than the thickness of the periphery of the valve, and the thickness of the edge portion of the cover provided with the fitting hole substantially corresponds to the difference between the thickness of the center of the valve and the thickness of the periphery of the valve.

Abstract: A septum penetrable by a member and which maintains a seal following member penetration in an axial direction and withdrawal. The septum includes a first layer of resilient material having first and second opposed surfaces, and a second layer extending across the first surface of the first layer and which is in radial tension. A third layer under tension may extend across the second surface. Septum assemblies and methods of fabricating the septa are also provided.

Abstract: A dispenser in which a dry powder (one component of a two-part adhesive tissue sealant and/or adhesive) is stored in a container (e.g., a carpule) having a septum at one end, an open end opposite the septum, and a movable plug. The powder is retained at the septum end of the container by the movable plug, which is displaced and pushed back as the solvent used for reconstituting the powder is introduced (e.g., through the septum). The second part of the tissue sealant is contained within a second container, also with a movable plug. After the first part is reconstituted, a manifold is fitted which pierces both septums and allows the contents to be dispensed. A dual syringe body supports the containers, and has pistons that enter the open ends to advance the movable plugs. Other embodiments of tissue adhesive and/or sealant dispensers and kits as well as methods of preparing tissue sealants are also described.

Abstract: A dispenser in which a dry powder (one component of a two-part adhesive tissue sealant and/or adhesive) is stored in a container (e.g., a carpule) having a septum at one end, an open end opposite the septum, and a movable plug. The powder is retained at the septum end of the container by the movable plug, which is displaced and pushed back as the solvent used for reconstituting the powder is introduced (e.g., through the septum). The second part of the tissue sealant is contained within a second container, also with a movable plug. After the first part is reconstituted, a manifold is fitted which pierces both septums and allows the contents to be dispensed. A dual syringe body supports the containers, and has pistons that enter the open ends to advance the movable plugs. Other embodiments of tissue adhesive and/or sealant dispensers and kits as well as methods of preparing tissue sealants are also described.

Abstract: The invention relates to an apparatus comprising a closure-cap and a container in the form of a two-chamber cartridge in which an active ingredient and a solvent can be stored separately until the apparatus is used in a nebuliser, as well as an active substance concentrate in which the active substance is present as a solution or suspension for storage purposes.

Abstract: A device for connecting between a recipient and a container, including a base, mounted on the recipient and a bush forming an inner bore, and a plunger adapted to slide in this bore, between a first position disengaged with respect to the stopper of the recipient and a second, so-called transfer position, in which a hollow needle borne by the plunger traverses the stopper. The base is provided with at least one elastic catch for retaining the plunger in the transfer position, this catch projecting, from the bush, towards the interior of the bore and being adapted to cooperate with an outer radial tab of the plunger.

Abstract: A mixing/charging port for medical treatment capable of reliably mixing/charging solutions or collecting the solutions in a medical instrument equipped with a solution feed passage, comprising a disc-like valve (1) having an insertion hole at the center, a cover (2) for restraining the valve (1) by covering at least the upper part of the periphery of the valve (1) with the center on the front surface side of the valve (1) left uncovered, and a round fitting hole (6) formed at the center of the cover (2) as anchor means for anchoring an insertion member to a mixing/charging port, the fitting hole (6) and the insertion member being so fitted to each other as to be capable of anchoring.

Abstract: A dispenser in which a dry powder (one component of a two-part adhesive tissue sealant and/or adhesive) is stored in a container (e.g., a carpule) having a septum at one end, an open end opposite the septum, and a movable plug. The powder is retained at the septum end of the container by the movable plug, which is displaced and pushed back as the solvent used for reconstituting the powder is introduced (e.g., through the septum). The second part of the tissue sealant is contained within a second container, also with a movable plug. After the first part is reconstituted, a manifold is fitted which pierces both septums and allows the contents to be dispensed. A dual syringe body supports the containers, and has pistons that enter the open ends to advance the movable plugs. Other embodiments of tissue adhesive and/or sealant dispensers and kits as well as methods of preparing tissue sealants are also described.

Abstract: A cassette is described including a housing, an inner reservoir located within the housing, a valve coupled to the inner reservoir and coupled to the housing, and a delivery conduit coupled to the inner reservoir and emerging from the delivery opening of the cassette. The cassette also includes a dispensing apparatus that defines a passage and has a first activating device that opens the valve of the cassette. The dispensing apparatus also has a second activating member capable of establishing fluid communication with a medicant container. A method of mixing a powdered drug and a liquid includes establishing fluid communication between the reservoir and the medicant container, dispensing at least a portion of the liquid into the medicant container, and transferring the mixed drug into the reservoir.

Abstract: A cannula lock useful for attachment to a cannula for administration of intravenous fluids to patients. The lock has dual access ports, each closed with a self-healing elastomeric material which can be pierced to introduce fluids into the lock. Having dual openings means one opening can be used for normal saline flushes, and another for injection of medicament fluid. In this way, the lock will last longer and can be more conveniently used at each administration.

Abstract: A spike for facilitating the introduction of liquid under pressure into a container containing a substance is provided which includes an elongate spike shaft having a spike side wall, a longitudinal axis, a distal end and a proximally located end portion, where the distal end has a sharp, pointed tip. An introduction channel is located within the spike shaft for receiving liquid into the container where a portion of the introduction channel is angled to cause liquid to travel out of the introduction channel in a direction non-parallel to the longitudinal axis of the spike shaft. An extraction channel may be included within the spike shaft for removing liquid from the container, where the extraction channel extends through the elongate spike shaft towards the proximally located end portion.

Abstract: The hollow cannula is made with a smooth tip to avoid sharp corners on the inside diameter or outside diameter in order to avoid scraping or scoring of a slit or pre-pre-pierced septum during passage through the septum. The cannula may be employed in various types of embodiments including swabable valve connectors.

Abstract: A luer connector which facilitates connection of a hypodermic syringe to the vial, comprising a luer connectable to a syringe and which extends to a sharpened end capable of being driven through a puncturable vial closure to thereby puncture the closure; a luer support, mountable on a vial, and which initially supports the luer in a first position in which the sharpened end of the conduit is pointed toward the closure; a luer driver such that movement of the driver relative to the support causes the luer to be driven so that the sharpened end punctures the closure and enters the vial.

Abstract: The present invention relates to a dosing device, or mixing device for mixing, in a continuous process, a flowing primary liquid with one or more added secondary liquids of a smaller quantity for obtaining a flowing liquid mixture at a permanent uniform mixing ratio of the mixed liquids.

Abstract: A fluid transfer device connecting a medicinal vessel and an intravenous (IV) bag for enabling the mixing in closed system of the two products contained therein by means of a syringe, comprising a three-way plug valve assembly (3) with a first port ending in a connector (5) for a syringe, and a second and a third port (8, 7), each one provided into a respective spike (1, 2) connected to a housing (16, 17) for a container of medicinal product. Within the first one of the said two spikes (1) a further independent channel (13) is provided for the inlet and the outlet of air, communicating with the external environment through a hydrophobic filter (14). The second one of said two spikes (2) is capable of piercing the rubber closure of the injection point of a bag of medicinal product, and the corresponding housing (17) consists of two flexible arms (18, 19) fastenable to each other at the respective ends, so as to be tightened around the tube of the said injection point.

Abstract: A cassette is described including a housing, an inner reservoir located within the housing, a valve coupled to the inner reservoir and coupled to the housing, and a delivery conduit coupled to the inner reservoir and emerging from the delivery opening of the cassette. The cassette also includes a dispensing apparatus that defines a passage and has a first activating device that opens the valve of the cassette. The dispensing apparatus also has a second activating member capable of establishing fluid communication with a medicant container. A method of mixing a powdered drug and a liquid includes establishing fluid communication between the reservoir and the medicant container, dispensing at least a portion of the liquid into the medicant container, and transferring the mixed drug into the reservoir.

Abstract: An injection site for passing a needle into an enclosed space surrounded by a wall, typically defined by a tubular section incorporated in a tubular set. An aperture in the wall communicates between the enclosed space and the exterior, having an elastic, needle-pierceable member such as a plug occluding the aperture. The plug is exposed to the exterior on one side and defines a route of needle access through the plug and aperture to the enclosed space. A first flange is positioned adjacent to the plug and extends transversely outwardly from the plug. The first flange carries a second flange, which extends longitudinally relative to the plug, and is spaced transversely outwardly from the plug to define a catch area for needles, which catch area surrounds the plug.

Abstract: A prefilled syringe capable of separate storage of different substances before use. It includes a tubular body having an injection needle at one end and a plunger at the other end, and a partition axially slidable in the tubular body. The partition includes a front part and a rear part independent of each other, and as a whole divides the interior space of the tubular body into a front compartment and a rear compartment in a sealing manner for storing mutually different substances. A bypass is disposed generally between the front and rear compartments to introduce the substance in the rear compartment into the front compartment when the partition is slid under pressure provided by the plunger to be adjacent to the bypass to thereby mix the substances immediately prior to injection.

Abstract: An injection site and unsharpened drug transfer spike for facilitating coupling a syringe to a fluid line. The injection site has a uniquely designed housing and septum comprised of only two parts. The drug transfer spike has a positive locking member for restricting retraction from the injection site once it is inserted for injecting a medicant. The positive locking member preferably comprises a annular ridge defined about the shaft of the drug transfer spike. The septum includes a pair of axially aligned, oppositely oriented conical recesses with adjacent apices either separated by a thin membrane or intersecting at the time of manufacture. The housing has an inlet for receiving the septum and comprises a plurality of fingers with inwardly extending tabs for constraining the septum therewithin. The septum is ideally adapted to be applied to injection sites, Y-connectors, vial adaptors, single or multi-dose vials and blood collection tubes.

Abstract: A syringe device for mixing two compounds is provided. The syringe device includes a vial having an opening and a centrally perforable stopper. The syringe device also includes a guide tube for guiding the injection end of the syringe between a withdrawn or storage position and an inserted position. The guide tube includes a second end for receiving the injection end of the syringe, which also includes a seal between the body of the syringe and the guide tube.

Abstract: A needle-less valve connector which employs a pre-slit elastomeric septum capable of axial movement proximally and distally within a housing. Connection of a blunt connector to the housing pushes the septum in the distal direction. A spring member biases the septum toward the proximal direction. The slit through the septum is held in the closed position, when the septum is in the proximal position, by an interference fit between the inside surface of the housing and the peripheral surface of the septum, with the interference fit causing an inward radial compression of the septum, orthogonal to the slit axis. The outer, or proximal, end surface of the septum can be shaped with a concave contour which causes the slit to completely close when the septum is in the proximal position. When a blunt connector is connected to the housing, the septum is pushed to a distal position, where other structure in the housing applies radial stress to the septum to open the slit.

Abstract: A medical valve element has a first solid portion of circular cross-section, a second cylindrical portion with a frustoconical interior passage, and a third hollow cylindrical portion featuring peripheral grooves. The valve element is made of elastomeric material and the first portion is surrounded by a solid metallic collar. The valve element is used in a medical valve. The valve has a cannula mounded on a hub and fixed in a fluid conduit so that the cannula points upstream. The elastomeric valve element is mounted on the hub within the conduit so as to enclose the cannula. In use, the valve element is compressed by application of a medical appliance to the valve element first portion to cause the cannula point to pierce the first portion to provide a path for fluid flow through the conduit. The collar causes the valve first portion to reseal upon removal of the medical appliance and expansion of the valve element back to its original condition.

Abstract: A blood withdrawal device has a withdrawal tube 2, a stopper 14 which closes the front end of the tube, can be pierced, and is retained by a stopper cap 5 which overlaps the tube with a collar 15, and a double cannula 3 which receives the stopper cap in a guide sleeve 4. The stopper cap or the guide sleeve has at least one prominence 17 which at least indirectly deforms the stopper cap in the collar region when this is pushed into the guide sleeve, the guide sleeve is rigid and at least the prominence of the stopper cap is non-rigid, preferably flexible. By this means, on the one hand secure holding of the guide sleeve and stopper cap is possible, without a catch or screw connection, and on the other hand it is possible, in a simple, gentle manner, to couple or connect several withdrawal tubes one after another to a cannula remaining in a vein, without jerking, and to fill several withdrawal tubes with blood.

Abstract: A combination pressure pod and access site apparatus is suitable for use in a medical tubing set. The combination pressure pod and access site comprises a pressure sensing chamber and a measured fluid chamber separated by a pressure transmissive diaphragm. An access site having a needle or needle-less septum is in fluid communication with the measured fluid chamber and permits and withdrawing fluids from, the measured fluid chamber through the access site. One or more of the combination pressure sites and access sites may be provided in a simplified blood tubing set for an extracorporeal blood treatment apparatus, such as a hemodialysis apparatus.

Abstract: Disclosed is a connector for introducing medication into a patient in a safe, convenient way. It comprises a pair of plastic tubular members adapted to be manually pushed together to engage in a male-female relationship, and a locking mechanism that detachably secures the members together. The male member has a sealed entry port at its end, and the female member safely houses within it a needle which centrally pierces the seal of the port upon engagement of the members. Preferably, the locking mechanism provides a "click" sound when it locks the members together.

Abstract: A coupling system for transferring fluids from a medicament-containing cartridge to an injection site comprises a fluid flow channel, a blunt cannula defining the distal end of the fluid flow channel, a needle cannula defining the proximal end of the fluid flow channel, and means for fixedly connecting the needle cannula to the blunt cannula.

Abstract: Improved elastomeric materials useful for medical and therapeutic device applications, such as penetrable septa, are described. In one aspect, the materials are deeply cleaned with solvent to significantly lower levels of undesirable organics. In another aspect, internally lubricated elastomer compositions compatible for use in medical and therapeutic device applications are provided. The lubricating fluid is present in the composition from about 0.5% to 50% by weight, and is initially substantially homogeneously dispersed in the elastomer. The fluid can be integrated into the elastomer by a solvent infusion method. In another aspect an internally lubricated thermoplastic septum, having an appropriate hardness for resealability with multiple penetrations, is provided.

Abstract: A prefilled, two-constituent system is provided with a syringe barrel having a dispensing end with an inwardly directed, stationary, piercing cannula. Within the syringe barrel is a first, sealed, collapsible container holding a first constituent at subatmospheric pressure. The first container is slidably disposed within the syringe barrel adjacent the piercing cannula. A second, sealed, collapsible container holding a liquid second constituent is slidably disposed within the syringe barrel spaced from the first container. A carrier is slidably disposed within the syringe barrel between the first and second containers. The carrier has a double-ended, hollow, piercing needle with oppositely extending first and second ends for piercing the first and second containers, respectively. A plunger is slidably mounted within the syringe barrel for applying a force to the second container.

Abstract: A valve device to enable aseptic injection and withdrawal of medical fluids into/from an infusion container. The valve device comprises a valve body with self-sealing passage portion (2), a surrounding portion (3) and a peripheral portion (4), and has an adhesive application surface (5). Located at the underside of the passage portion is a pressure relief zone (6), and at the upper side an insert zone (7). The surrounding portion (3) has a pronounced upright edge. The valve device is manufactured in one piece of the same material and can be simply applied and handled on the occasion of use while retaining aseptic conditions even by persons of impaired sight.

Abstract: A needle connector assembly for attachment to an IV receptacle which includes a needle hub with a cannula or needle attached thereto and a housing to which the needle hub is mounted. The hub has a plurality of equi-spaced splines thereon and the housing has an aperture in the rear portion thereof defining a plurality of equi-spaced slots therein which mate with the splines when the hub and the housing are secured together. Along the length of the interchangeable splines and slots, an inwardly projecting, one-way barb is provided which has an inclined or cam surface at its leading edge. When the hub is inserted into the housing, the needle is completely surrounded by the housing and the barbs bite into the adjacent material to preclude withdrawal of the hub from the housing. The housing and the receptacle may interlock with each other at a patient IV site to secure the housing to the receptacle.

Abstract: A prefilled syringe is capable of separate storage of different substances before use. It includes a tubular body having an injection needle at one end and a plunger at the other end, and a partition axially slidable in the tubular body. The partition includes a front part and a rear part independent of each other, and as a whole divides the interior space of the tubular body into a front compartment and a rear compartment in a sealing manner for storing mutually different substances. A bypass is disposed generally between the front and rear compartments to introduce the substance in the rear compartment into the front compartment when the partition is slid under pressure provided by the plunger to be adjacent to the bypass to thereby mix the substances immediately prior to injection.

Abstract: An improved closure insert is provided for throat region of a blow-molded container. This closure insert is provided with a scabrous perimeter and is permanently molded into the container throat region during container formation from a parison. The resulting seal resists loosening or disturbance when off-axis force or torque force is applied to the closure insert during container opening. The closure insert can be a subassembly constituted by removable parts that provide a variety of access options to the container contents.