Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Patent
1994-09-26
1996-08-13
Green, Randall L.
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
604186, 604135, A61M 500
Patent
active
055451446
DESCRIPTION:
BRIEF SUMMARY
The present invention is directed to the dosing of liquid preparations. More specifically, the invention refers to a method and a system for the repeated dosing of liquid pharmaceutical preparations which are to be administered. Still more specifically, the invention refers to a method and a system for the repeated dosing and administering of liquid pharmaceutical preparations by parenteral injection from a multi-dose container. Furthermore, the invention also refers to a device for carrying out the method of the invention, especially then in the form of an injection device for repeatedly administering parenteral injections from an injection cartridge.
When a pharmaceutical agent is prescribed by a physician, the amount or dose to be administered to the patient is usually expressed in well-known units, such as milliliters or international units (IU). The dose is determined by such factors as the health status and weight of the patient, for example, and by rules from the health authorities. In those cases where the patient himself is to administer the doses, the physician then selects a suitable multi-dose container, from which a number of doses may be administered. Such a multi-dose container may be a vial, from which each individual dose is withdrawn by means of a hypodermic syringe, or it may be in the form of an injection cartridge, which is to be inserted in an injection device for repeated administrations. Injection cartridges have found a wide use because of the easiness in their handling and the diminished risk of infections, especially when the patient has to give himself repeated administrations. Injection devices in the shape of a pen for repeated injections of such preparations as, for example, insulin and growth hormones are commercially available. The user inserts an injection cartridge in the device and attaches an injection needle to the cartridge, and the device is then ready for repeated injections. The device may be set at different doses and is usually graduated in such units as milliliters or International Units.
It is usually desirable that the dose is set in such a way that there will be a minimum residue of the preparation in the multi-dose container after a series of injections have been administered. This is of special importance when very expensive preparations are administered, such as growth hormones. This is not a problem when the multi-dose container is a vial from which the individual doses are withdrawn. If the remaining amount of preparation in the vial is insufficient for a complete dose, the user simply takes the missing amount from a fresh vial, and there will be no unused residue.
However, this is not possible when an injection cartridge is used in an injection device of a known type, and depending on the relation between the prescribed dose and the contents of the cartridge, the residue may be considerable. For instance, for a cartridge containing 12 I.U. of a preparation, only the doses of 1, 2, 3, 4, 6, and 12 I.U. will leave no residue, but for other doses, there will be a considerable waste. Thus, for example, a dose of 4.5 I.U. will give a residue of 3 I.U. after two administrations, and a dose of 8 I.U. will give a residue of 4 I.U. after one administration. A dose of 6.25 I.U. will give a residue of 5.75 I.U. after one administration, that is, nearly half of the contents of the cartridge. For very expensive preparations, such as growth hormones, this is quite unacceptable.
It is not suitable for the user to give himself two injections to administer the prescribed dose, as this will mean that a new dose value has to be set for the first injection from the second cartridge, and the prescribed dose value then reset. This may easily lead to errors in the calculation and setting of the doses.
For expensive preparations, special dosage schemes have been tried, where the dose is varied from each administration to the subsequent one. This complicates the prescription for the physician, and may also lead to errors. Furthermore, this means that only the average dose will
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Fryklund Linda
Gustavsson Marie-Louise
Hjertman Birger
Kaluski Jacob
Levander Gustav
Green Randall L.
Pharmacia AB
Van Over Perry E.
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