摘要:
Luer lock type connection device for medical use having a nozzle in which an axial internal passage is formed. The nozzle includes a bearing connection surface and a proximal annular retention zone. The connection device also has a flange forming an axial open seat having a wall that includes a distal part with internal screw thread, and a transverse proximal part in which a central proximal retention opening is formed, and whose diameter is matched to that of the proximal annular zone of the nozzle. The proximal annular retention zone of the nozzle and/or the central proximal retention opening of the flange include a circular band or cord covered or treated with a roughening agent.
摘要:
The invention concerns a plastic package, having a content capable of being sterilised at high temperature, said package comprising at least a fluid communication member (16) between the inside and the outside of said package consisting of at least a frame circumscribing an opening and an inner seal (18) closing the opening, and whereof the peripheral edge (18a, 22a) is continuously linked to said frame, said inner seal including, a selectively sealing material sheet whereof the cutoff threshold from outside inwards, stops contaminating particles and allows through the thermal sterilising fluid, said selectively sealing material being deformable in the plane of said sheet at said high temperature. The invention is characterised in that it comprises means compensating the planar deformation of the selectively sealing material sheet, when said inner seal (18) is in contact with the thermal sterilising fluid, said compensating means being designed to release at least part of the load in the direction opening the fluid communication member (16) applied on the frame as a result of said deformation.
摘要:
A pre-fillable hypodermic syringe is provided. The hypodermic syringe includes a syringe barrel having opposed proximal and distal ends and a drug-receiving chamber therebetween. The distal end of the syringe receives a needle cannula that is sealingly and protectively covered by a cap. The proximal end of the syringe is sealed by a stopper assembly. The stopper assembly includes a distal stopper that is positioned adjacent the drug pre-filled into the syringe barrel. The distal stopper is formed to exhibit acceptably low sliding forces without the presence of lubricants deleterious to the drug. The stopper assembly further includes a proximal stopper formed from a material that exhibits acceptable microbiological sealing. Because the proximal stopper is separated from the drug by the distal stopper the proximal stopper may be treated with any convenient lubricant, such as silicone oil. The distal stopper functions as a barrier between the drug and the lubricant such as silicone oil that is on or near the proximal stopper. The proximal stopper, on the other hand, provides the required microbiological sealing.
摘要:
A resealable vial featuring a fluid access device having a membrane for selectively opening or sealing a fluid passageway between the bottle and the fluid access device. The vial includes a body disposed on said bottle. The fluid access device can be configured as a spike assembly, a needle assembly, or a luer lock assembly, and features a hollowed rod in sliding, fluid-tight relation to an orifice defined by the body. A membrane, preferably formed from an elastomeric material, is secured across both the orifice and the open top of the bottle, and may be retained between the top surface of the bottle and the body. The membrane preferably includes a central area sealing the orifice from the open top of the bottle, with one or more fluid passages defined on a portion of the membrane outside of the central area. A force exerted upon the hollowed rod deflects the membrane towards the interior of the vial, urging the membrane and fluid openings away from the body to open the fluid path between the bottle and the orifice. A sealing rib may be provided around the portion of the periphery of the recess for sealing contact between the central area of the membrane and the orifice.
摘要:
The invention concerns a plastic package, having a content capable of being sterilised at high temperature, said package comprising at least a fluid communication member (16) between the inside and the outside of said package consisting of at least a frame circumscribing an opening and an inner seal (18) closing the opening, and whereof the peripheral edge (18a, 22a) continuously linked to said frame, said inner seal including, a selectively sealing material sheet whereof the cutoff threshold from outside inwards, stops contaminating particles and allows through the thermal sterilising fluid, said selectively sealing material being deformable in the plane of said sheet at said high temperature. The invention is characterised in that it comprises means compensating the planar deformation of the selectively sealing material sheet, when said inner seal (18) is in contact with the thermal sterilising fluid, said compensating means being designed to release at least part of the load in the direction opening the fluid communication member (16) applied on the frame as a result of said deformation.
摘要:
A bottle having a sterility seal and a method for producing same are disclosed. The bottle, which can be configured to retain a medicament in powder or tablet form, features a protective cap configured to engage a transfer assembly associated with the bottle. The cap includes one or more raised ridges on an interior surface engageable with a portion of the transfer assembly. A band or layer configuration of a sealing material such as silicone is applied to the transfer assembly prior to insertion of the cap thereover. As the cap comes into surface contact with the sealing material, the ridges cause the material to "roll up" into a toroidal O-ring configuration, thereby forming a seal between the cap and the bottle adapted to the dimensional variations of those components. The seal, which is resilient, is able to withstand harsh handling treatment and pressure or temperature variations without separation from the cap or bottle, thereby providing a hermetic seal isolating the transfer assembly and, hence, the medicament from the outside environment.
摘要:
A transfer set for transferring fluids from a first container, such as a conventional vial, to a second container, such as a conventional syringe. The transfer set includes an integral tubular housing having a tubular collar surrounding the rim of the vial, a radial portion sealingly engaging the stopper in the vial, an integral tubular transfer member and an outer tubular portion surrounding at least the distal portion of the tubular transfer member, a piercing member within the tubular transfer member and a closure releasably retaining the distal end of the piercing member.
摘要:
A transfer set for transferring fluid, including drugs, vaccines, medicaments, solutions and the like, between a first container, such as a conventional vial, and a second container, such as a conventional syringe having a unique multipurpose resealable member. The transfer set assembly includes an elastomeric tubular fluid transfer and resealable valve member preferably including an open end mounted on the pierceable closure or stopper of a vial and a generally closed distal end having a longitudinal slit and a piercing member is telescopically received within the fluid transfer valve member having a piercing end opposite the pierceable closure. The fluid transfer valve member is preferably formed of silicone and is surrounded by a generally tubular luer connector member having an open end mounted on the pierceable closure and a distal end having male luer threads. This assembly is enclosed within a cup-shaped closure and the assembly is retained to the first container or vial by a collar preferably secured to the vial by crimping. Upon removal of the cup-shaped closure, fluid communication between the vial and a second container, such as a syringe, is achieved by threading the luer connector of the syringe on the luer threads of the tubular luer connector member, which drives the tip through the slit of the elastomeric fluid transfer valve member against the distal end of the piercing member, driving the piercing end through the pierceable closure. In the preferred embodiment, the piercing member includes a generally longitudinal channel which establishes communication between the vial and the syringe through the tubular fluid transfer valve member.
摘要:
A transfer set assembly for transferring fluids between a first container, such as a conventional medical vial, having a sealed open end and a second container such as a conventional IV infusion bag. The transfer set includes a collar having a proximate tubular end portion for securement to the container, a needle cannula and holder assembly, which is telescopically received in a distal tubular portion of the collar, and a closure including a tubular body portion having an open proximate end which is telescopically received over the needle cannula and holder assembly and the distal tubular portion of the collar, a closed distal end portion and an inner tubular portion which is integral with the closed distal end. The inner tubular portion includes a free end having spiral camming surfaces which mate with spiral camping surfaces on the inside surface of the tubular distal portion of the needle cannula holder. The tubular body portion of the closure includes lateral slots which receive projections on the collar and contiguous camming surface which extends toward the proximate open end of the closure. Rotation of the closure relative to the collar first drives the mating spiral camming surfaces of the closure and holder together, thereby driving the needle cannula and holder assembly axially to pierce the seal of the container. Continued rotation of the closure drives the projections on the collar against the contiguous angled camming surface, driving the closure from the collar and providing access to the needle cannula for transfer of fluids to a second container, such as an IV infusion bag.
摘要:
A method of sealing a cartridge having a barrel with a polymeric closure, wherein the polymeric closure includes a tubular collar portion and an integral radial portion, The method includes disposing the tubular collar portion over the radial rim portion of the barrel to surround the reduced diameter neck portion and incrementally rolling and radially deforming the tubular collar portion adjacent its free end into the reduced diameter neck portion with a crimping tool, wherein the polymeric closure is sufficiently malleable to permit radial deformation, yet sufficiently rigid and resistant to creep to retain its shape following deformation The crimping tool or tools include an inclined surface having a gradually decreasing angles of inclination which are driven against the tubular collar portion adjacent the free end and the cartridge assembly and crimping tool are relatively rotated.