Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-03-12
2001-11-20
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S082000, C604S191000
Reexamination Certificate
active
06319225
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an injection syringe including a device for preparation of an injection in situ, useful to the injection which is liable to suffer chemical changes if left for long time in the state of solution or dispersion ready to inject. This invention particularly relates to an injection syringe portable by a patient who may prepare a necessary injection for himself in situ with use of a device included in the syringe which will automatically perform an injection with a prescribed dosage.
DESCRIPTION OF THE RELATED ART
Traditionally where a patient has to sit for injections regularly for a long period, for instance, injections of human growth hormones or insulin, such system has been employed as the patient always carries a kit of injection syringe and performs injections for himself. In this application in situ, an injection syringe is designed to be ready to be assembled by himself as well as to be suitable to multiple usage by exchange of ampules and needles. In this category, there has been known a portable syringe made up to be similar to a fountain pen.
On the other hand, in such application in situ as noted, some chemical substances including human growth hormones as well as interferon are subject to suffer unnegligible chemical changes only due to stirring or shake which may he occur in the process of dissolution or storage after the dissolution. Such environmentally sensitive substances are normally stored in ampules in the freeze-dried state, but careful treatment is required so that excessive mechanical force will not affect to such solution (or injecto. Plural form is “injections”) during handling in dissolution or storage thereafter.
In view of such technical requirement as noted, in the case of an injection syringe including a multichambered cylindrical ampule which contains a solid medicine in a front space and a medicinal solvent in a rear space, and in the step of forwarding the rear gasket to let the solvent flow slowly into the front space en route of bypass, the known art has often employed the mechanism comprised of a manually turnable thread and a plunger connected with the rear gasket in order lo control a inflow rate. But complexity involved in such operations as well as stirring or shake with the syringe due to manual turning is unavoidable, and thus harmful affections to solutions or injections remain as task to be solved.
Further the front face of the space wherein a solid medicine was contained is sealed during the dissolution step and a remnant gas under compression remains at a tip of the space and then in the stop of injection or in the step of mounting an injection needle at the front tip of the space, as a result, the remnant gas will spout. Such action will exert an impact to the solution. Unfavorable consequence.
Heretofore such various systems have been proposed as will prepare injections with use of the multichambered ampule, but such systems heretofore admit of further improvement in the point of preventing possible stirring or disturbance to flow and other mechanical impacts affecting to the injections.
SUMMARY OF THE INVENTION
This invention is intended to offer an injection syringe in including a device for preparation of an injection, whereby mechanical impacts affecting to the medicine and consequently, chemical changes with a medicine would be minimized during the step of dissolving the medicine sealed in a space of the multichambered ampule and during the steps of storing and injecting the injection after the dissolution, and the injection syringe also including a device for dosage control as well as automatic injection, convenience to a patient who carries such injection syringe.
The target application of this invention lies in an injection syringe which will handle various polypeptides of environmentally sensitive nature including human growth hormones, interferon and which may be operated by a layman patient himself with readiness in situ.
The studies prove that a best suitable process for dissolution of an unstable freeze dried machine with a medicinal solvent is performed by manual control of the solvent flow with adequate slowness which will be monitored by eye observation on mixing conditions, and as for the injection step, it is proved that the dosage control will be optimized with use of an injection operator to be provided with syringe. In order for the syringe to be suitable for such requirements, a cylindrical ampule is sheathed or inset within a two-part case which will be retractable/extensibly by telescopic move between the two cases and which will be connected with an injection controllar or dosage controller. Thus dissolution will be performed with no working of the injection controllar which will work at the step of injection. Further, because the injection will possibly cause a back-flow due to the remnant gas as noted above, a reverse prevented mechanism may be optionally employed.
REFERENCES:
patent: 5281198 (1994-01-01), Hber et al.
patent: 5549561 (1996-08-01), Hjertman
patent: 5569191 (1996-10-01), Meyer
patent: 5630800 (1997-05-01), Blank et al.
patent: 5807323 (1998-09-01), Kriesel et al.
Igarashi Yutaka
Ishikawa Hiromichi
Kirihara Sei
Sugita Koichi
Nihon Chemical Research Co., Ltd.
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Seidel Richard K.
Thanh Loan H.
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