Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-06-27
2004-07-20
Thanh, LoAn H. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06764463
ABSTRACT:
FIELD OF THE INVENTION
The following invention relates generally to a method and apparatus for storing a first substance, preferably dry, activating the first substance with a second substance, preferably a liquid, and subsequently transferring the diluted, mixed substance from storage into a syringe or cannula without the need for a needle and without appreciable contact with ambient air. More particularly, the present invention relates to a storage container for storing a substance that has undergone a lyophilization process and is ready for the introduction of a substance to evolve into a medium that may be then utilized according to its appropriate prescription. More specifically, the instant invention is specifically tailored to inhibit the lability of pharmaceuticals or extend its useful shelf life.
BACKGROUND OF THE INVENTION
The potency, efficacy, freshness and/or safety of many substances degrade over time. For example, powder mixed with a diluent has a shelf life of 72 hours or less, while lyophilized powder alone has a shelf life of years. FDA regulations require manufacturers to mark their ready to use and unmixed products identifying a date of expiration which states explicitly that the contents contained therein will not be as effective, fresh or safe to use subsequent to the date printed on the identification mark. This is of particular concern to pharmaceutical companies dealing with the efficacy of their pharmaceutical products degrading over time, because of many pharmaceuticals' labile nature. This degradation may reach a point where using the particular pharmaceutical product beyond the date imprinted on the bottle could result in the pharmaceutical providing no effect, not enough effect or negative effects on persons taking the product as prescribed by the pharmaceutical manufacturer's directions, distributor's directions, seller's directions, product's directions, pharmacy's directions and/or the attending physician's directions. With lyophilized products, directions for use after mixing typically mandate use before a certain number of hours. The onus for proper use at this point shifts from the manufacturer to the caregiver.
The instant invention chronicles the ongoing efforts of the applicant to address the needs of the medical community. Applicant's issued patents are as follows: U.S. Pat. Nos. 5,102,398; 5,370,626; 5,538,506; 5,716,346; and 6,045,538.
SUMMARY OF THE INVENTION
The instant invention inhibits the labile nature of substances. In its most elemental form, the instant invention is a specialized container to store dry product. In particular, the instant invention takes advantage of the lyophilic process and provides a container for storing the lyophilisate to inhibit the lability of pharmaceutical products. In this patent application, the container is to be called an ampule. This container provides an aseptic environment that prevents bacteria from propagating to the pharmaceutical product which would effect the product in an adverse manner. The container is configured to receive liquid in such a way that the dry product can be diluted without appreciable exposure to ambient air. Because powder alone and powder mixed with a substance can be mutagenic, confined mixing without dispersion, released/aero solution or contamination is critical, and the instant invention addresses these critical concerns.
Further, the instant invention provides for a process that dissolves a dry, powdery or dry, pelletized substance stored in a dry, plastic ampule. The ampule has a first coupler defining an outlet which has been sealed during manufacture by occluding the first coupler outlet with a first cap.
To use the dry substance, it must first be dissolved. The cap is removed, exposing the coupler/outlet and liquid is introduced. The powder is dissolved and the resulting mixture is removed for use.
The container is constructed to discourage any appreciable ambient air from contaminating the system. This minimizes nosocomial infections.
Further, the instant invention completely avoids the use of a needle. The instant invention takes advantage of a coupling that is the standard on a majority of syringes which had heretofore only been used in the past to support the hypodermic needle on the syringe. This coupling, called a luer fitting, has a male component and a female component. Typically, the syringe is configured with the “male” luer coupling which appears as a truncated cone that has an opening at its end. Some luer couplings are threaded. The luer coupling typically diverges toward an interior cylindrical hollow portion of the syringe. The coupler of the instant invention replicates the “female” luer coupling normally associated with the needle per se. Preferably liquid is introduced via a syringe by connecting the respective luer couplers of the syringe and ampule. The coupler provides a tight, reliable seal. The walls of the ampule are flexible. Flexible walls not only promote removal of liquid, but also avoid introducing ambient air into the ampule. Instead of venting air at the coupler, the walls of the ampule flex.
The syringe can be prefilled in as described in U.S. Pat. No. 5,102,398 or can be filled as described in U.S. Pat. No. 5,716,346.
Once filled, the syringe feeds the ampule with liquid for mixing. After mixing, the contents of the ampule is then retransferred back to the syringe (while preferably still docked to the ampule) with none or a minimal, negligible amount of ambient air introduced. The flexible side walls of the ampule can collapse as the liquid from the ampule is loaded into the syringe but it is primarily the coupling that eliminates ambient air invasion.
Once the ampule has been removed, a syringe has the intended mixture of medication disposed therewithin. Unlike the prior art, no needle has yet been involved. Also, no air from the ambient environment has been mixed with the sterile fluid as was the case with rigid wall containers that require pressurization.
In one form of the invention, it is contemplated that the opening associated with the ampule is provided with a removable cap having a luer-type coupling and an indicia bearing tab. The medicinal contents of the ampule is stamped on the tab for identification purposes. With such an arrangement, it is possible to transfer the cap and tab from the ampule and connect the cap to the syringe to provide a tell tale of the contents of the fluid contained within the syringe. As an alternative, the ampule could remain docked to the syringe until actual use to act both as a sterility cap and identify the substance in the syringe because the ampule would also note the contents on a surface thereof.
As a result of this system, the entire process for dissolving and mixing a dry substance and then filling a syringe has been accomplished without the use of a needle. Personnel are able to operate more quickly with less fear of either inadvertent needle stick or inadvertent exposure to the medicine contained within the syringe.
It is to be noted that for many in-patients, the standard procedure in a hospital is to tap into a person's vein only once with an infusion catheter and to leave the catheter needle in place with tubing communicating therewith so that subsequent fluids such as intravenous drips and the like can be used. With such a system, a needle would never be needed with the syringe according to the present invention. “Y” connectors are well known in the art, one branch of which and would have a complemental female luer coupling. Thus, for a patient's entire stay at a hospital, the only needle associated with that one patient, ideally, would be the one which initially had been placed in the patient's vein to support the infusion catheter. In this way, the opportunity for inadvertent needle sticks would be reduced to a minimum.
OBJECTS OF THE INVENTION
Accordingly, the primary object of the present invention is to provide a method and apparatus for transferring sterile fluid from an ampule to a hypodermic syringe after mixing
Kreten Bernhard
Thanh LoAn H.
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