Bottles and jars – Closures – Self-sealing – piercable-type closure
Reexamination Certificate
1999-10-20
2001-04-03
Shoap, Allan N. (Department: 3727)
Bottles and jars
Closures
Self-sealing, piercable-type closure
C141S329000, C222S083000, C604S413000, C604S414000, C604S415000, C215S258000, C215S307000, C215S355000, C215SDIG003
Reexamination Certificate
active
06209738
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an improved transfer set for vials and other medical containers which may be attached to a conventional vial, for example, having an elastomeric stopper or other closure for transferring fluid under sterile conditions between the medical container and a second container such as a conventional intravenous (IV) infusion bag. The transfer set of this invention assures sterile delivery of the substance in the container, provides clear indication of tampering and protects the healthcare worker.
BACKGROUND OF THE INVENTION
It is conventional to store pharmaceutical substances such as drugs in a sealed vial or other container for later use. Such pharmaceuticals may be in a dry or powdered form to increase the shelf life of the substance and reduce inventory space. Such dry or powdered substances are generally stored in a sealed vial and reconstituted in liquid form for administration to a patient by adding diluent or solvent. Alternatively, the substance may in a liquid or even a gaseous form.
A conventional vial for storing such substances generally includes an open end, a radial rim portion surrounding the open end and a reduced diameter neck portion adjacent the rim portion. The vial is conventionally sealed with an elastomeric stopper or closure which includes a generally tubular portion or an annular rib which is inserted into the neck of the vial and a generally planar rim portion which overlies the vial rim. The stopper is normally secured to the vial with a thin malleable metal cap, such as aluminum. The aluminum cap includes a tubular portion which surrounds the rim portion of the stopper and vial, an inwardly projecting annular rim portion which overlies the rim portion of the stopper and a free end portion which is crimped or deformed radially into the vial neck beneath the vial rim portion. Because aluminum is malleable, the collar accommodates the buildup of tolerances of the dimensions of the stopper and rim portion. The dimensions and tolerances of standard vials and rims are set by the International Standards Organization (ISO).
The radial portion of the aluminum cap which overlies the stopper rim portion may be closed, in which case the aluminum cap is removed by peeling the aluminum cap from the vial. A pre-slit tab located in the midportion is provided which overlies the vial rim, permitting the cap to be torn from the top and peeled from the vial prior to use. This embodiment of an aluminum cap has several disadvantages. First, the tearing the metal cap creates sharp edges which may cut or damage sterile gloves and cut the healthcare person administering the drug, thereby exposing both the healthcare worker and the patient to disease and contamination of the drug. Second, the tearing of the aluminum cap generates metal particles which may also contaminant the drug. The dangers associated with the tearing of an aluminum cap has been solved in part by adding a “flip-off” plastic cap. This embodiment, however, does not eliminate the possibility of tearing the sterile gloves of the healthcare worker. Further, aluminum dust is still created which may contaminant the medicament. It should also be noted that metallic dust is also created by forming and affixing the aluminum collar to the vial, particularly during the crimping of the vial and removal of the flip-off plastic cap.
Aluminum collars have also been used to secure fluid transfer sets on vials. Transfer sets may be utilized, for example, to transfer fluid from a syringe to a vial or an IV infusion bag to a vial such as to reconstitute a dry or powdered drug in a vial by adding diluent or solvent. The reconstituted drug may then be withdrawn from the vial into the IV infusion bag or a syringe. There have been attempts to reduce this problem by applying a coating to the aluminum cap or collar. The prior art also includes snap-on cup-shaped plastic caps or collars having a radially inwardly projecting end portion that is snapped over the rim portion of the vial. Snap-on plastic collars, however, do not assure adequate sealing of the vial or full accommodation of the tolerances of standard vials and stoppers as required.
As discussed below, the disclosed embodiment of the fluid transfer set of this invention is particularly, but not exclusively, adapted for transferring fluids between a sealed container, such a vial having an elastomeric stopper, and an IV infusion bag. A conventional IV infusion bag includes one or a plurality of tubular ports which are sealed prior to use. As set forth above, the vial or other medical container is also sealed. The transfer of fluids between a vial and an IV infusion bag for example requires piercing of the seal in the port to the IV infusion bag and communication with the interior of the vial generally provided by piercing the elastomeric stopper. In a typical application, the vial includes a dry or powdered substance and the IV infusion bag includes a liquid solvent or diluent. It is thus necessary to transfer the liquid in the IV infusion bag to the dry or powdered medicament in the vial to reconstitute the drug, then transfer the reconstituted drug to the IV infusion bag.
Various improvements have been made to transfer sets for transferring fluid between medicament vials and IV infusion sets, particularly the MONOVIAL® prefillable IV infusion system offered by the assignee of the present invention as disclosed, for example, in U.S. Pat. Nos. 5,487,737; 5,533,994; and particularly 5,855,575 assigned to the Assignee of the present invention. These improvements include safeguards against damage and contamination and a shield around the needle cannula used to pierce the tubular port of IV infusion bag which safeguards the healthcare worker. This transfer set system, however, requires a special stopper or closure for the vial. Reference is also made to U.S. Pat. No. 5,250,037 assigned to the assignee of the present invention which discloses an improved syringe having needle isolation features, wherein the needle cannula extends from both ends of the needle holder for transfer of fluids between the syringe and a second container such as an IV infusion bag. The barrel portion includes bayonet grooves and the closure includes projections received in the bayonet grooves, such that rotation of the closure drives the proximate end of the needle cannula through a seal on the syringe. The transfer assembly disclosed in that patent, however, requires a special syringe.
The transfer set assembly of this invention may be utilized with any sealed container including conventional sealed pharmaceutical vials preferably having ports up to 14.5 mm and may be utilized to transfer fluids between the sealed container and any second container, including a conventional IV infusion bag. Further, the transfer set of this invention assures sterile conditions of the transfer set during filling of the container and use of the transfer set and container assembly. Finally, the transfer set of this invention is simple to operate and protects the healthcare worker during use.
SUMMARY OF THE INVENTION
As set forth above, the transfer set assembly of this invention may be utilized to transfer fluids between a first container having a sealed open end, such as a conventional vial having an elastomeric stopper, and a second container, such as a conventional IV infusion bag, under sterile conditions. It is important to emphasize, however that the use of the transfer set assembly of this invention is not limited to any particular container, such as the conventional vial or an IV infusion bag as described herein.
The transfer set assembly of this invention includes a collar, a needle cannula and holder assembly, and a closure. The collar includes a proximate tubular end portion which is adapted to be received over the sealed open end of the first container for securement to the container. In the most preferred embodiment of the transfer set assembly of this invention, the collar is formed of a polymer which is sufficiently malleable to permit radial deformation of the fr
Jansen Hubert
Thibault Jean-Claude
Becton Dickinson and Company
Eloshway Niki M.
Shoap Allan N.
Wark Allen W.
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