Swabbable needleless vial access

Abstract

The invention provides for a cleansable, i.e., swabbable, access pot, formed by a stopper having a bore extending from an entry position to an exit position; and a plug in the bore at the entry position and movable in the bore; whereby the location of the plug at the entry position of the stopper permits the cleansing or swabbing of the outer surfaces of the plug and the stopper before the plug is depressed into the bore of the stopper for a vial or container in order to reduce the danger of contamination of the bore by pathogens. To convert from single-use vial access, to multiple-use vial access, the plug is replaced by a swabbable, needleless, multiple-use lock connector in which the plug contains a slit that is closed upon initial depression but is thereafter openable to permit flow through the connector into a vial or container.

Description

FIELD OF THE INVENTION [0001] This is a continuation-in-part of Ser. No. 09 / 073,022, filed May 4, 1998. The invention relates to coupling systems for the transfer of materials from one unit to another, and, more particularly, to coupling units with a first unit including a swabbable access port and a second unit including a blunt cannula. The access port receives the blunt cannula to effect a coupling of particular medicinal applicability for medications and body fluids. The swabbability of the access port allows disinfectant treatment before receipt of the blunt cunnula to limit the extent to which pathogens can enter the cannula after coupling is effected. BACKGROUND OF THE INVENTION [0002] In medical practice, containers for medication typically are bottles capped with rubber-like stoppers. A tamper-evident seal surrounds the stopper and at least the upper portion of the container. To administer medication, the seal is removed, a syringe with a needle or cannula is used to punctu...

AI Technical Summary

Benefits of technology

[0019] In accomplishing the foregoing and related objectives, the invention provides for a cleansable, i.e., swabbable, access port, formed by a stopper having a bore extending from an entry position to an exit position; and a plug in the bore at the entry position and movable in the bore; whereby the location of the plug at the entry position of the stopper permits the cleansing or swabbing of the outer surfaces of the plug and the stopper before the plug is depressed into the bore of the stopper in order to reduce the danger of contamination of the bore by pathogens.

[0026] In another aspect of the method, the steps include engaging a collar of the stopper at the entry position of the bore; engaging external Luer threads of the collar; stretching an apertured membrane that spans the exit position of the bore; and causing fluid to flow in an auxiliary channel of the bore when the plug is depressed in the bore.

[0028] The invention enables the needleless and disinfected transfer of medication using a stopper with a movable plug having an integral surface for engagement of the plug by a fitment, such as the Luer end of a syringe. By using the invention, medication can be withdrawn from a container with or without the use of a needle, after disinfectant treatment of the engagement surface of the plug to remove pathogens and possible contaminants.

Problems solved by technology

The need for a needle of cannula presents a potential hazard, both to medical personnel and to the patient.

There is significant risk of infection by blood-transmitted diseases, AIDS and hepatitis from needle sticks.

Access ports that are pierced by a cannula can be physically damaged by repetitive piercings and produce coring or laceration of the access port, which can result in leakage.

After repeated entries, the stopper can leak because of coring and no longer function as a swabbable sterile barrier.

Alternatively, the pathogens and particulate matter may contaminate the contents of the vial.

Moreover, pointed cannulae used with drug vials pose a health risk to their users because of problems associated with infectious agents.

Despite the fact that personnel using pointed cannulae do so with great care, from time to time accidents occur, and the users are jabbed or suffer needle sticks.

Used needles also present a risk of injury and handling problems for health care facility maintenance and waste removal personnel.

Dispensing pins tend to disengage from the vial stopper with resultant leakage.

Further, it is difficult to maintain sterile conditions on this kind of multiple dose system.

Injection sites used with a blunt cannula have the advantage that the cannula will not pierce the skin of a user, but the pre-slit injection site has to reseal with enough force that fluids do not ooze outwardly and not allow airborne particulate matter, bacterial or viral, to enter.

Unfortunately, the open end of the valve in Brony is below the inlet of the stopper so that germs can collect on the inside wall of the stopper and not be cleansed.

As a result, the use of the vial in Brony can be accompanied by dangerous pathogens.

Further, the injection site should be usable with a blunt cannula with a reasonable level of insertion force that will permit health care personnel to readily insert the cannula, but yet not have the cannula easily displaced after insertion.

This system is both complex and cumbersome.

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