Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-11-19
2002-09-10
Casler, Brian L. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
Reexamination Certificate
active
06447476
ABSTRACT:
BACKGROUND OF THE INVENTION
Safe and hygienic application of predetermined doses of medical fluids such as eye drops and the like rely on an adequate storage of those doses in an ampoule device without danger of introducing contaminants. Substantially, the same holds true for cosmetic samples in form of predetermined amounts of a cosmetic fluid prefilled in an ampoule device for a single use by test persons without danger of contamination through use of other persons.
Usually, those non-refillable ampoule devices should have a construction being as simple as possible, cheap in production and, furthermore, offering, despite of their simple construction, a reliable performance and easy manipulability for the patient or customer, respectively.
These features should also be maintained as far as possible for prefilled ampoule devices in which two or more fluids have to be stored in such a way that it is possible to apply the mixed fluid components.
For the above purposes, there have been developed a plurality of ampoule or vial devices with one or a plurality of chambers offering the possibility of applying a desired amount of fluid by means of a brush or other tool to be inserted into the chamber or chambers, respectively, or alternatively, by means of a syringe or nozzle-like mechanism combined with the vial or ampoule device. (U.S. Pat. No. 5,636,931, Patent Abstracts of Japan vol. 096, no. 011, 29. November 1996 & JP 08 187121 A, EP 0577200A1, U.S. Pat. No. 3,870,147, DE 9202654, U.S. Pat. No. 4,927,282, U.S. Pat. No. 4,793,476, EP 0 295 265 B1, WO 9208506, U.S. Pat. No. 5,330,048, EP 0090413 A1, U.S. Pat. No. 2,478,844, CH 367284, DE 4406503, U.S. Pat. No. 4,391,590).
Before applying the fluid or fluid mixture, the user must operate a mechanism for providing access to the fluid or fluid mixture. A plurality of solutions require rupturing a closure member or a weakened breaking point. Other solutions merely require a telescopic action between at least two device members in order to transfer the application fluid into an accessible chamber. Such a solution is e.g. disclosed in U.S. Pat. No. 4,741,737 and U.S. Pat. No. 4,809,711 of Meyer et al describing a prefilled ampoule-syringe.
Furthermore, the inventor of the present application disclosed in his earlier WO 98/63994 (U.S. Pat. No. 6,227,736 filed on Oct. 20, 1998), assigned to the same assignee as the present application, a prefilled ampoule device with a brush-like application tool, having an outer sleeve and an inner sleeve being subjected to a telescoping movement. The inner sleeve is liquid-tightly and slidingly provided in the outer sleeve, and it has transverse openings near its bottom. Above the openings, the inner sleeve comprises an annular sealing groove which, in the closed storage position of the ampoule device, engages an annular sealing lip protruding from the inner wall of the outer sleeve. In addition to the sealing means, locking means are provided for locking the inner sleeve within the outer sleeve.
Though a plurality of devices have already been developed especially for medical purposes there is still a need for a simplified construction which, nevertheless, is reliable and easy to manipulate.
SUMMARY OF THE INVENTION
The main object of the present invention is to provide an improved prefilled ampoule device which has a simplified construction, can be manufactured and assembled in an easier manner and at less expense, and offers the possibilty of adapting it to various application purposes without changing the basic design.
This main object is achieved in a prefilled telescoping ampoule device comprising:
a receptacle made of elastomeric material including a hollow cylindrical body having a closed lower end, an open upper end, and a peripheral sealing lip projecting radially inwardly from the inner wall of the cylindrical body between the closed lower end and the open upper end thereof;
an insertion member including a cylindrical portion having a closed lower end, an open upper end, a transverse opening radially extending from the outer wall into the interior of the cylindrical portion, and a longitudinal passage axially extending within the interior of the cylindrical portion from the transverse opening to the open upper end of the cylindrical portion;
the cylindrical portion of the insertion member with its closed lower end ahead being inserted into the open upper end of the hollow cylindrical body and being arranged therein for coaxially telescoping movement of the receptacle and the insertion member towards one another from a closed storage position to an open release position;
wherein, in the closed storage position, the closed lower end of the cylindrical portion of the insertion member is spaced a distance from the lower end of the hollow cylindrical body so as to define therein a cylindrical chamber containing a substance, and the peripheral sealing lip of the cylindrical body is sealingly pressed into circumferential contact with the outer wall of the cylindrical portion of the insertion member at a location above the closed lower end of the cylindrical body and below the transverse opening so as to prevent release of substance from the chamber into the transverse opening and to frictionally hold the insertion member in place within the receptacle during transportation and storage, and
wherein in the open release position, after telescoping movement the lower end of the cylindrical portion of the insertion member is positioned at or close to the lower end of the cylindrical body of the receptacle and the transverse opening of the cylindrical portion of the insertion member is located below the sealing lip of the cylindrical body resulting in a reduced volume of the chamber and a release of substance from the chamber into the transverse opening and the longitudinal passage of the cylindrical portion of the insertion member, and the sealing lip of the cylindrical body is sealingly pressed into circumferential contact with the outer wall the cylindrical portion of the insertion member at a location above the transverse opening so as to prevent escape of substance from the chamber to the upper open end of the hollow cylindrical body of the receptacle.
A main advantage of the present invention is that it achieves a reliable performance by providing a single sealing lip without a corresponding sealing groove and any additional locking means.
The prefilled substance is accessible by dipping an applicator tool such as a brush into the insertion member in the open release position of the device or, alternatively, is ejected from the open end of insertion member during the telescoping movement from the closed storage position to the open release position.
In adapting the device of the present invention to the first alternative the longitudinal passage of the cylindrical portion of the insertion member has in relation to the outer diameter of the cylindrical portion a large inner diameter so as to define a cylindrical chamber within the cylindrical portion of the insertion member.
In adapting the device to the second alternative the insertion member includes a coaxially extending tubular portion integrally formed on top of the cylindrical portion having a smaller outer diameter than the cylindrical portion and ending on its upper end in an open tip, and the longitudinal passage is provided in form of a narrow conduit extending from the cylindrical body into the tubular portion up to the open tip thereof.
Furthermore, due to the simple construction, it is possible to provide more than one insertion member such that after telescoping movement of all insertion members and the outermost receptacle two or even more prefilled substances are mixed with each other. Hence, it is possible to mix several prefilled liquid substances or even a prefilled solid substance with liquid substances.
Whenever a second or even a third substance is provided within a first or even a second insertion member an additional sealing lip is provided in the receptacle such that, in the closed storage position, this additional sealing li
Casler Brian L.
Dentaco Dentalindustrie-und Marketing GmbH
Quarles & Brady LLP
Sirmons Kevin C.
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