Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1998-11-18
2001-04-10
Bockelman, Mark (Department: 3734)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S192000, C604S198000
Reexamination Certificate
active
06213977
ABSTRACT:
The present invention is related to facilitating injection, especially subcutaneous injection by providing a means and methods which enable a correct penetration depth of the needle and thereby to achieve a correct therapeutical effect from the injected drug even if the injection site is altered by the patient.
It is highly desirable for a manufacturer and supplier of pharmaceuticals to meet the demands from patients who are confined to a long time regimen of adminstration by self-injections. Such patients require safe and convenient equipment which to the highest possible extent will liberate them from the burden of repeated drug taking by injections. It must also be considered that many such patients are elderly or of infant age and might have a reduced physical strength and a strong aversion of needles. Many attempts have therefore been made to provide injection devices which hide or cover the needle for the user and only exposes it at the moment of adminstration. These devices also have the advantage that they cover the needle from inadvertent contamination before adminstration and also provide safety from accidental needle sticks from a used needle. Another requirement of self-injections is that they must be repeatable in order to provide the patient with a correct dose of the pharmaceutical. Since the bioabsorption may vary considerably for a given drug depending on the whether it is administered subcutaneously or intramuscularly, it is of high importance to have a fixed penetration depth of the needle for repeated injections. An inaccurate injection depth may even in certain applications lead to varied effect of the drug which for example for a diabetic dependent on insulin might have fatal consequences.
A means which can be used on an injection device for limiting the penetration of the needle which also entirely covers the needle for the user is disclosed in the International patent application PCT/SE92/00596. With this needle cover it is, however, not, possible to adjust the penetration depth of the needle, which is a drawback for especially when it is desired to inject the drug into the subcutaneous fat layer. A penetration depth adjustment is especially advantageous when injecting drugs subcutaneously, because the subcutaneous fat layer not only varies considerably between individual patients, it also varies between different parts of an individual body, for example between the thigh, the abdominal area, the arms and the legs. For many drugs, especially polypeptides or proteins like insulin, factor VIII and human growth hormone, also the bioabsorption may vary considerably between intramuscular and subcutaneous adminstration and also many times locally between different subcutaneous injection sites. In addition, many such drugs might demonstrate an improved activity when administered subcutaneously such as the factor VIII-preparations disclosed in the International patent applications WO 95/01804 and PCT/SE95/00348.
It would therefore be a significant improvement in convenience and safety for many patients to obtain an injection device which can give them a higher freedom to select and alter the injection site, while retaining a correct injection depth for each adminstration so a repeated drug effect is maintained.
It would also be an improvement to be able to benefit from the advantages of subcutaneous adminstration and be able to freely select subcutaneous injection sites based on individual desire.
An object of the present invention is to provide a device which maintains all the advantages of a needle covering device while also making it possible to readily adjust the needle penetration depth between different pre-set values. This object is attained by the needle covering device as defined herein.
It is also an object of the present invention to is provide a method of adjusting the penetration depth of the needle of an injection apparatus.
Another object of the present invention is to provide an improved method of administering a drug by subcutaneous injection so that a correct penetration depth of the injection needle in the subcutaneous fat layer of patient always is obtained.
A further object of the invention is to provide a kit for subcutaneous injection comprising an injection apparatus and a tubular needle covering device attachable thereto, by means of which a correct subcutaneous injection can be obtained irrespective of the injection site.
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Cseke Rudolf
Hertig Guido
Hjertman Birger
Pavlu Bohdan
Bockelman Mark
Hamilton LLP Pepper
Pharmacia AB
Pouliquen Corinne M.
Villacorta Gilberto M.
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