Single-use syringe

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S110000, C604S200000, C604S212000, C604S213000, C604S215000, C604S217000

Reexamination Certificate

active

06605064

ABSTRACT:

BACKGROUND OF THE INVENTION
The storage and dispensing of fluids, and more particularly sterile fluids used in medical applications requiring use of a needle, is plagued by a host of difficulties which detract from the optimal use of such sterile fluids. For example, in cost-sensitive applications, multi-dose vials provide an economical means of packaging medical fluids but also increase the likelihood of contamination of the remaining contents when multiple needles are used to penetrate the sterile environment of the vial. This is an even greater problem in animal health applications where the same needle is often used to inject a medical fluid such as a vaccine into multiple animals. Reentry of a contaminated needle into the multi-dose storage container may lead not only to a loss of sterility but to severe contamination of the remaining contents with infectious disease causing organisms. Such contamination may require the disposal of the remaining non-sterile medical fluid if not used immediately, or worse, the transmission of infectious disease organisms between animals.
When conventional syringes are used to draw fluids such as vaccines from multi-dose vials, considerable time and effort can be lost in the process, particularly in animal applications. The user must go to a cold storage area, locate a vial containing the desired fluid, transport the vial to the location where the fluid is to be administered, penetrate the sterile barrier of the vial with a needle, withdraw a single dose of fluid, and administer the dose to the animal. In many instances the vial is stored in a refrigerator at some distance from where the fluid is to be administered, particularly when the animal being treated is located in the field. After use, the vial containing the remaining fluid must be returned immediately to the refrigerator to maintain product quality. The time cost of maintaining cold chain conditions on the medical fluid can be a major inconvenience to the user and can result in variable observation of handling instructions on the product label. For the reasons discussed above, a cost-effective, preloaded, single-use syringe would represent a major advance in the art.
SUMMARY OF THE INVENTION
The present invention relates, in one aspect, to a single-use syringe comprising a needle housing, a bore-containing fluid-delivery needle and a volume-containing element. The needle housing has a top surface to which the volume-containing element is attached, a needle attachment side to which the bore-containing needle is attached, and a fluid delivery channel in communication between the top surface and the needle attachment side. The volume-containing element is fluid-tight but for communication with the fluid-delivery needle and a filling port. Embodiments are disclosed which include vapor-permeable portions which facilitate lyophilization of materials in situ.


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