US20050150855A1

US20050150855A1 - Medicament container

Info

Publication number: US20050150855A1
Application number: US10/754,646
Authority: US
Inventors: Karl Woods
Original assignee: Individual
Current assignee: Individual
Priority date: 2004-01-09
Filing date: 2004-01-09
Publication date: 2005-07-14

Abstract

A container for injectable medicines includes an inner wall and an outer wall, with a sterile environment disclosed therebetween. A method for using the container includes inserting a needle for a hypodermic syringe through a seal in the outer wall, and intaking sterile air into the syringe. The hypodermic needle is then inserted through a seal in the inner wall and into the medicine contained therein. A proper dosage of the medicine is then intaken into the syringe, and it is withdrawn from the medicine container.

Description

FIELD OF THE INVENTION

The present invention relates to an improved sterile medicament container for containing medicines, particularly injectable medicines.

BACKGROUND OF THE INVENTION

Sterile containers are standard for injectable medicaments or medicines are standard and are known in the art. An example of a container for injectable medicines can be found in, for example, U.S. Pat. No. 4,364,485 which discloses an injectable fluid container and method. This patent discloses a container which is provided with an anti-tampering seal. U.S. Pat. No. 4,364,485 is hereby incorporated by reference as if set forth in its entirety herein.
With multi-use medicament bottles, especially for those designed for home use by a person who is not necessarily a trained medical professional, it is important to maintain the purity of the medicament inside the container.
Maintaining a sterile environment is an important consideration for medicament containers, especially those containing injectable medications. Most medicament containers of this type include a bottle with a neck, and an elastomeric seal at the top of the neck. The seal is designed to be penetrated by a syringe while maintaining purity of the medicament within. Typically, before inserting a hypodermic needle, or other delivery system, into the container, the seal is sterilized by application of alcohol, or an equivalent disinfectant.
U.S. Pat. No. 5,803,284 discloses a sterile closure assembly for sealing a medicament container. This patent shows a membrane which is hermetically disposed over an elastomeric plug in the container. The membrane insures a sterile environment prior to the first use of the container. U.S. Pat. No. 5,803,284 is hereby incorporated by reference as if set forth in its entirety herein.
Many individuals, with needs for ongoing injections, need to self-administer the injections. An example of this is that many diabetic individuals need to self-administer insulin injections. In order to prevent contamination, several steps are generally recommended for users. The medicament containers are typically vacuum sealed to prevent contamination. The stopper in the container is preferably penetrable by the needle, but is essentially impermeable to the surrounding atmosphere. Syringes and needles are generally recommended to only be used once and then discarded. It is generally recommended that the syringe, plunger and needle be boiled, or in the alternative, if this is impracticable, that they be immersed in alcohol (e.g. isopropyl alcohol) for a period of time before use. The stopper in the bottle is to be wiped with alcohol prior to insertion of the needle.
One drawback to known containers is that typical injections require that air be drawn into the syringe prior to inserting the needle of a syringe through the seal into the medicament container. This air is then inserted into the medicament container, and the medicament is drawn into the syringe. The air drawn into the syringe from the surrounding atmosphere can be contaminated and can thus contaminate the medicament inside the vial.

SUMMARY OF THE INVENTION

The present invention provides an improved system, whereby a region of sterile air is maintained within the container, thus allowing the user to draw sterile air into the syringe prior to the insertion of the hypodermic needle into the medicament itself. This can help maintain the purity of the medicament, and can prevent impurities from subsequently being injected into the user's body.

BRIEF DESCRIPTION OF THE DRAWING

The above, as well as other advantages of the present invention will become readily apparent to those skilled in the art from the following detailed description when considered in the light of the accompanying drawings in which:
The FIGURE is an illustration of a medicament container in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

It is to be understood that the invention may assume various alternative orientations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification are simply exemplary embodiments of the inventive concepts defined in the appended claims. Hence, specific dimensions, directions or other physical characteristics relating to the embodiments disclosed are not to be considered as limiting, unless the claims expressly state otherwise.
The FIGURE shows a medicament container 10 which has an outer housing or wall 12 and an inner housing or wall 14. Disposed between the outer housing 12 and the inner housing 14 is an annular region 22. The annular region 22 is filled with sterile gas or air to maintain a sterile environment. The gas in the annular region 22 can be at atmospheric pressure, or can be pressurized or at a negative pressure. In a preferred embodiment of the present invention, the gas is originally at a positive pressure, to ensure that as air is removed from the annular region 22, sufficient gas remains in the annular region 22 for future applications. In any case, the annular region 22 should contain sufficient gas to allow for eventual displacement of all of the medicament contained within the inner housing 14.
The outer housing 12 has a seal or stopper 16 which is designed to allow penetration by a hypodermic needle or other delivery device. Similarly, the inner housing 14 also has a seal or stopper 18 which is also designed to allow penetration by the hypodermic needle.
Each of the inner housing 14 and the outer housing 12 can preferably be made from glass or a plastic material. Generally, any material known in the art which is suitable for containment of the medicament in question is acceptable for use in the present invention. The seals 16, 18 are preferably made of an elastomeric material suitable for penetration by a hypodermic needle, but resistant to permeation by gas or fluid. Such seal materials are well known in the art, and any such known material is suitable for use herein. In at least one embodiment of the present invention, at least one of the seals comprises rubber. As is standard in the art, the container is preferably vacuum sealed to prevent contamination of the contents. In a preferred embodiment of the present invention, the gas in the annular region 22 is inert, i.e. not active with regards to the medicament contained in the inner housing 14. Also, the gas in the annular region 22 should be generally be inert with regards to its effect on the human body, should trace amounts of the gas be inadvertently left in the syringe in addition to the medicament. In general, sterilized atmospheric air is suitable for use herein. Other gases may, however, be preferred for certain medicaments.
In at least one embodiment of the present invention, the inner 14 and outer 12 housings have a common base 20. In other possible, but not shown embodiments of the present invention, the inner and outer housings can have separate bases. In such a case the separate bases should be adhered to each other in a manner to maintain the inner and outer housings in position relative to each other.
In a method according to the present invention, a hypodermic needle of a syringe is inserted through the stopper 16 of the outer housing 12. Subsequent to the insertion, sufficient gas is withdrawn into the syringe to displace the desired dosage of medicament. After gas is taken into the syringe, the needle is inserted through the stopper 18 of the inner housing 14 and into the medicament to be withdrawn. The gas is then displaced from the syringe and the proper dosage of medicament is taken into the syringe. The syringe is then withdrawn, and the medicament is ready to be injected into the patient. By following the above method, contamination of the medicament can be minimized, and thus, delivery of contaminants to the patient can also be minimized.
In a preferred embodiment of the present invention, the outer seal 16 is made from a material which can collapse or deform upon the application of pressure. This can be advantageous in that: subsequent to the intake of air into the syringe, the user can apply pressure to the syringe which can be transmitted to the outer seal 16, which will press the outer seal 16 near or against the inner seal 18. This deformation of the outer seal 16 can then allow shorter hypodermic needles to penetrate into the interior of the inner housing 14 to retrieve the medicament.
The above method and device are suitable for both self-administered medicaments, and medicaments which must be delivered by another person. Additionally, the above method and device are suitable for single use medicament containers, and medicament containers containing sufficient medicament for multiple doses. While the above container and method are believed to be suitable for application of a variety of injectable medicaments, it is believed that the container and method are especially suitable for the administration of insulin to diabetic patients, which is commonly a self-administered medicament.
In accordance with the provisions of the patent statutes, the present invention has been described in what is considered to represent its preferred embodiments. However, it should be noted that the invention can be practiced otherwise than as specifically illustrated and described without departing from its spirit or scope.

Claims

1. An improved container for an injectable medicament, comprising:

an inner housing containing a medicament disposed therein, said inner housing having a seal disposed therein, said seal being penetrable by a hypodermic needle;

an outer housing, said outer housing having a seal disposed therein, said seal being penetrable by a hypodermic needle;

said seal of said inner housing being aligned with said seal of said outer housing to allow a hypodermic needle to pass through each of said seals; and

a sterile environment contained between said inner and outer housings.

2. The medicament container according to claim 1, wherein said sterile environment contains sterile air.

3. The medicament container according to claim 1, wherein each of said inner and outer housings comprise glass or plastic.

4. The medicament container according to claim 1, wherein said medicament comprises insulin.

5. The medicament container according to claim 1, wherein each of said inner and outer seals comprise an elastomeric material.

6. A method for preparing a sterile medicament injection comprising:

providing a container having an outer housing with a penetrable seal, an inner housing with a penetrable seal, and a sterile atmosphere disposed therebetween, the container containing a medicament within the inner housing;

providing a hypodermic needle;

inserting the hypodermic needle through the seal in the outer housing;

drawing air into the hypodermic needle from the sterile atmosphere;

inserting the hypodermic needle through the seal in the inner housing; and

drawing medicament into the hypodermic needle from inside the inner housing of the container.