Fluent material handling – with receiver or receiver coacting mea – Filling means with receiver or receiver coacting means – With puncturing connecting means
Reexamination Certificate
2001-10-11
2004-04-06
Maust, Timothy L. (Department: 3751)
Fluent material handling, with receiver or receiver coacting mea
Filling means with receiver or receiver coacting means
With puncturing connecting means
C141S002000, C141S097000, C141S319000, C141S366000, C141S383000, C141S384000, C604S411000
Reexamination Certificate
active
06715520
ABSTRACT:
BACKGROUND OF INVENTION
1. Technical Field
The present invention relates to a fluid transfer assembly comprising a bottle connector and a drug bottle, wherein the bottle has a neck with an opening covered by a closure and the connector has a hollow needle for penetrating the closure when establishing a fluid transfer line in the fluid transfer assembly. The invention further relates to a neck element, a bottle connector, and a drug bottle for use in such a fluid transfer assembly, and to a method for fluid transfer using the fluid transfer assembly.
2. Background Information
When preparing drugs, e.g., intended for injection or infusion, demands are made on aseptic conditions. As a rule, special safety boxes or cabinets located in a clean room environment have been utilized in order to achieve such aseptic conditions.
A serious problem in connection with drug preparation and other similar handling is the risk of exposing medical and pharmacological staff to drugs or solvents which might escape into the ambient air. This problem is particularly serious where the preparation of cytotoxins, antiviral drugs, antibiotics and radio-pharmaceuticals are concerned. It has been found that safety boxes according to the present technology often provide insufficient environmental protection. For example, cytotoxins can evaporate at room temperature. Safety boxes and cabinets according to the present technology are provided with filters for filtration of circulating and exhaust air. Conventional, or HEPA filters are able to trap aerosols and particles, but not evaporated substances. Furthermore, aerosols and other particles which are initially trapped in the filters can transform into their gas phase and be released into the ambient air. For these reasons, there is a need for safer systems for handling drugs and other medical substances.
Accordingly, U.S. Pat. No. 4,564,054 to Gustavsson (“the '054 patent”) discloses a fluid transfer device for transferring a substance from one vessel to another vessel while avoiding leakage of liquid and gas contaminants. The device comprises a first member designed as a hollow sleeve and having a piercing member, thereby providing a passageway. The piercing member is attached to the first member, which has a first barrier member at one end just opposite the tip of the piercing member. Thereby, the piercing member can be passed and retracted through the first barrier member that seals one end of the first member.
The fluid transfer device of the '054 patent further comprises a second member that is attached to or attachable to one of the vessels or to means arranged to communicate therewith. The second member has a second barrier member and mating connection means arranged on the first and second members for providing a releasable locking of the members with respect to each other. The barrier members are liquid and gas-proof sealing members, which seal tightly after penetration and retraction of the piercing member and prevent leakage of liquid as well as gas contaminants. In the connected position of the first and second members, the barrier members are located in such a way with respect to each other that the piercing member can be passed there through.
According to the '054 patent, the above-mentioned piercing member is a needle arranged for puncturing the first and second barrier members, wherein the end opposite to the one end of the first member has means for sealingly receiving or being permanently attached to an injection syringe or the like for withdrawing and/or adding substance to the vessel attached to the second member. When attached to the first member, the injection syringe or the like communicates with the passageway of the needle, so that in the retracted position the needle is hermetically enclosed in the first member having the injection syringe or the like connected thereto.
In another system for handling drugs and other medical substances, International Patent Application No. PCT/US98/24665 to Fowles et al. (“the '665 application”) discloses a connector device for establishing fluid communication between a first container and a second container. The connector device has a first sleeve member with a first and second end. The first sleeve member has a first attaching member at the first end that is adapted to attach to the first container. The connector device further has a second sleeve member with a first and second end. The second sleeve member is combinable with the first sleeve member and movable with respect thereto from an inactivated position to an activated position, wherein the second sleeve member has a second attaching member at the second end adapted to attach the second sleeve member to the second container.
According to the '665 application, the connector device further comprises a first and second piercing member projecting from one of the first and second sleeve members for providing a fluid flow path from the first container to the second container. The connector device further provides a means for independently hermetically sealing the first and second members.
Still, it has been found that the current systems for safer handling of hazardous medical substances often are difficult to connect to drug bottles (or other fluid containers) which are used for the handling. Furthermore, in some of the previously known systems there may be a risk that a drug bottle or other handling container accidentally is detached from the handling system. This is of course not acceptable.
One difficulty when connecting several of the present handling systems to a drug bottle having an opening covered by a membrane or another closure is that a hollow needle or other piercing member of a connector device or the like has to penetrate the membrane substantially perpendicularly and with a linear motion in order to avoid that the membrane is ruptured or that the aperture through the membrane formed by the hollow needle becomes too large and allows hazardous substances to escape into the environment. This linear motion can be difficult to achieve with the present fluid transfer systems, and requires a great amount of care and patience from the user coupling such a connector device to a drug bottle.
SUMMARY OF INVENTION
Accordingly, a first object of the present invention is to provide an improved fluid transfer assembly comprising a bottle connector and a drug bottle, which solves the above-mentioned problems and which in a reliable, consistent way reduces the risk of hazardous leakage to the environment. This first object is achieved by means of a fluid transfer assembly having a bottle connector and a drug bottle. The bottle can have a neck with an opening covered by a closure, and the connector can have a hollow needle for penetrating the closure when establishing a fluid transfer line in the fluid transfer assembly. According to the invention, the assembly further comprises a neck element with locking members for irreversible coupling to the neck and to the connector. The neck element and the connector further have interacting guiding members for directing the hollow needle to penetrate the closure at a predetermined angle when establishing the fluid transfer line.
A second object of the present invention is to provide a neck element for use in the fluid transfer assembly according to the invention. This second object is achieved by a neck element for use in a fluid transfer assembly. The neck element has a bottle connector and a drug bottle. The drug bottle has a neck with an opening covered by a closure, and the connector has a hollow needle for penetrating the closure when establishing a fluid transfer line in the fluid transfer assembly. According to the invention, the neck element has locking members for irreversible coupling to the neck and to the connector. The neck element further has guiding members for participating in directing the hollow needle of the connector to penetrate the closure at a predetermined angle when establishing the fluid transfer line.
A third object of the present invention is to provide
Andreasson Kjell
Strandhav Jerry
Carmel Pharma AB
Howrey Simon Arnold & White , LLP
Maust Timothy L.
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