Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1997-09-02
2001-08-28
Dawson, Glenn K. (Department: 3761)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S019000, C604S181000, C604S187000, C604S192000
Reexamination Certificate
active
06280418
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a container to be used for long-term storage, as well as for direct dispensing of injection, infusion, and diagnostic preparations, having fill volumes in the range of 10 to 200 ml. In particular, the invention relates to a storing and dispensing container comprising a glass barrel having, on a top end, a sealed portion that can be opened for dispensing into a hollow needle or infusion tube, and having, on a base end, a grip, a stopper that serves as a plunger, and a connection point where a supporting plunger rod can be connected.
2. Description of the Prior Art
For the purpose of dispensing injection, infusion, and diagnostic preparations, glass containers for storing the preparations are distributed as fully filled and sealed with a rubber stopper. This rubber stopper is formed in such a way as to be self-sealing when repeatedly pierced by a syringe needle, particularly by one of the plastic, disposable syringes now in common use This allows the needle to be drawn repeatedly from the storage container.
It is also known that the aforementioned storage containers can be made, or rather equipped with additional components, in such a way that they can retain the function of syringes, and their respective preparations can be dispensed directly from the container itself. This eliminates the need for transferring from a container to a now standard plastic syringe, significantly reducing the energy expended and the risks of confusing and contaminating the preparations. In addition, when considering the total cost of drug delivery, administering preparations directly from the container represents by far the most economical possibility.
Such a container is known from European Patent No. 0,298,585 A1, having a fill volume between 20 and 100 ml and is in principle a vial with a variable bottom. With a total height to diameter ratio of no more than 2.5:1, this container corresponds to typical injection vials that have analogous dimensions of less than 2.9:1. In place of a glass bottom, this vial has a rubber stopper to which a plunger rod can be mounted. Similarly, section 1, the mouth of the vial is designed as a flared flange, sealed with a rubber stopper similar to DIN ISO 8362, section 2, and has an aluminum flange cap, to secure the rubber stopper in its position.
To activate, the center area of the rubber stopper must be accessible. For flange caps that do not have an existing center opening, but are instead sealed, the center area is first removed. For this, an opening mechanism with a preset breaking point is provided. Then, in the next step, the exposed area of the rubber stopper must be disinfected, followed by the actual activation of the vial by placing an activating fixture over the flange cap. The activating fixture is equipped with a needle that is centered on the side facing the rubber stopper such that the rubber is pierced when the fixture is put into place, providing access to the preparation. For injection purposes, the needle can be two sided, i.e., the one side serves to puncture the rubber for activation, while the other, longer side of the needle functions as a hypodermic needle. For other purposes, the activation fixture is only provided with the needle on the one side, while the other side is designed as an interlocking, conical joint. A hollow needle or, alternatively, an infusion tube can be connected to this joint.
The disadvantage to this familiar container is that only once the activation fixture is in place does the function of the variable bottom vial become that of a syringe. The dimensions of this syringe, however, have a total height to outer diameter ratio of no more than 2.5:1, making the syringe unusable for common syringe pumps, as these are envisioned for the non-filled, disposable, plastic syringes currently on the market.
Being able to insert the syringe into a syringe pump is nevertheless a significant demand, as the preparation in many medicinal applications is dispensed by means of a syringe pump, into which a syringe is inserted. The supporting plunger is moved by an adjustable feed, while the body of the syringe is fixed, thus expelling the preparation into an infusion tube. In practice, forces of over 50 N can be applied to the syringe grip, and so the grip of any syringe suitable for syringe pumps must be able to withstand tractive forces significantly higher than 50 N.
An overview of typical syringe pumps currently on the market is given in the American Journal of Hospital Pharmacy, Vol. 48, October 1991, Suppl. 1, pp. S36-S51 (publisher, American Society of Hospital Pharmacists, Inc.).
A further disadvantage of this known container system lies in the need for an activating fixture in addition to the container. Cleaning the rubber stopper in the area where the activating needle pierces the stopper, as well as where the activating fixture is placed, requires a significant amount of handling.
Furthermore, rubber stoppers must always be punctured, possibly producing tiny rubber particles, which can be problematic from a medical point of view.
A further disadvantage of the known system lies in the necessary use of aluminum flange caps, which, on the one hand, produce abrasive particles during the filling process and, on the other hand, complicate recycling and separation of materials in non-pharmaceutical areas.
Yet another barrel that can be packaged with a syringe is known from German Patent No. DE 3,924,830 A1. This barrel consists of a glass pipe having, on one end, a retractable plunger rod with finger support and, on the cannula, a locking component in the form of a pierceable rubber stopper with headpiece. This syringe barrel is noted for its complicated design and numerous pieces; when using the syringe, rubber components must be punctured, leading to the disadvantages explained earlier. Inclusion of a finger support and headpiece increases the diameter of the syringe barrel to wider ranges, thereby having the disadvantage of making impossible the use of such syringes in syringe pumps. The same is true of the analogously built syringes found in German Patent No. DE 3,916,101 A1 and PCT Patent Publication No. WO 91/01152.
SUMMARY OF THE INVENTION
The task underlying this invention is to create a container of the type described in the introduction, which requires a minimum amount of handling when dispensing the preparation, allows for dispensing with typical syringe pumps currently on the market, does not require any rubber parts to be punctured, contains no metal components, and is particularly economical to manufacture.
The solution to this task is achieved in the present invention by:
converting the dimensions of the container, with respect to the total height to outer diameter ratio, to the dimensions of a standard syringe (ratio is larger than 2.5:1),
molding a tapered glass headpiece onto the glass barrel, thereby forming a single unit with a connector cone at the top end that serves as a nozzle,
attaching a separate, threaded section of a plastic, interlocking, conical joint concentric to the connector cone,
designing the threaded section to accommodate a sealing cap that serves as a stopper and can be sealed via the connector cone, and
mounting a plastic grip, which can withstand a tractive force of at least 100 N, onto the interior wall of the glass barrel.
This design has the advantage that, when dispensing the preparation, an infusion tube or needle can be immediately attached after the simple process of removing the sealing cap. Another particularly important feature is that a plastic grip is mounted on the inside of the syringe barrel. In this way, the grip and barrel can be designed in such a way that the exterior contour of the container—even in the transition area from the grip to the syringe barrel—is identical to the exterior contour of plastic syringes now used in syringe pumps. This guarantees that the container of the present invention can be accommodated by all current syringe pumps. In addition, the small number of
Reinhard Michael
Spallek Michael
Dawson Glenn K.
Kilpatrick & Stockton LLP
Schott Glaswerke
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