Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-09-11
2003-04-08
Nguyen, Anhtuan T. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S090000
Reexamination Certificate
active
06544213
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a dual compartment, mixing and dispensing device suitable for packaging and premixing pharmaceutical preparations just prior to direct administration to a patient.
BACKGROUND OF THE INVENTION
Due to degradation and formation of unwanted by-products, many two component pharmaceutical formulations must be stored separately prior to administration. Formulations characterized as two components, wherein the components must be pre-mixed in specified proportions prior to administration, i.e. in vitro mixing, are placed in separate containers for distribution. Prior to administration, exact amounts of each component must be pre-measured, combined, and mixed to provide a formulated dosage. Often these two-component preparations are not accurately measured or improperly mixed, and sometime multiple doses of pre-mixed formulation are stored for excess time. Typical of the two component preparations are oral vaccines and medications, opthalmic and nasal preparations, etc.
Prior art devices having multiple compartments for the separate containment of enclosed components for mixing prior to use are disclosed in U.S. Pat. Nos. 3,340,873, 3,354,883, 3,397,694, 3,411,503, 4,412,836, 4,330,531, 4,331,146, 4,950,237 and 5,217,433. These references disclose various novelties from mixing mechanisms to hydraulic pressure seal removing devices.
It is an objective of the present invention to provide a device for easily pre-mixing and administering a multi- or unit-dose of formulation just prior to the use thereof. Yet another objective of the invention is directed to processes for filling the device, and pre-mixing and dispensing a formulation from the device.
This and other objectives of the present invention will become apparent from the description and drawings herein.
SUMMARY OF THE INVENTION
The present invention is directed to a dual compartment, mixing and dispensing device suitable for containment and premixing of two separate components prior to administration to a patient, comprising:
a. first and second tubular-shaped compartments having open ends and walls for internal containment of first and second components, respectively, wherein the compartments are axially aligned;
b. an orifice connecting the first and second compartments together at an open end of each compartment along the axial alignment;
c. a transition wall on the second compartment at the orifice-second compartment interface comprising a reciprocally inverting conical-shape, concave wall, which funnels towards the orifice, and a continuous edge defined as the circumference of the second compartment leading to the conical-shape, concave wall, wherein the conical-shape, concave wall being perpendicular to the axially alignment of the compartments, said conical-shape, concave wall second compartment capable of inverting to a conical-shape, convex wall by forcing the first and second compartments towards each other along the axial alignment thereof;
d. closing means at the open end of the first compartment opposite the orifice to prevent flow of components therefrom;
e. a dish seal located inside the orifice being axially removable to the second compartment, the dish seal having first and second closed ends, the first end abutting the first compartment and the second end extending into the second compartment, the second end having a seal-pushing element attached thereto, wherein the dish seal prevents intermixing of the first and second components, and wherein the seal-pushing element moves perpendicular to the axial alignment;
f. a disc-shaped, flange element located on the exterior of the orifice at the orifice-first compartment interface, perpendicular to the axial alignment, wherein the diameter of the flange is proximal to the continuous edge of the transition wall of the second compartment; and
g. sealing means at the open end of the second compartment opposite the orifice to prevent flow of the components therefrom,
the first component being dispensed into the first compartment; the second compartment being reciprocally inverting along the axial alignment toward the first compartment to invert the conical-shape, concave wall to the conical-shape, convex wall so that the continuous edge of the second compartment contacts the flange element, wherein the concave-shape of the transition wall inverts to the convex-shape; the dish seal being placed in the orifice to contain the first component in the first compartment; a second component being dispensed into the second compartment; the second compartment being sealed to contain the second component, wherein forcing the compartments away from one another along the axial alignment at the orifice, causes the convex, transition wall to contact the seal-pushing element, thereby removing the dish seal from the orifice, wherein the conical-shape, convex wall inverts to a conical-shape, concave wall.
The dual compartment, mixing and dispensing device is useful for separate containment of two, pre-measured pharmaceutical components that a pre-mixable in the device immediately prior the direct administration to a patient. Upon flexing and pulling the compartments apart, the dish seal, which prevents flow of the two components to opposite compartments, is dislodged from the orifice allowing the components to readily mix in the compartments to provide a formulated multi- or unit-dose of medication. A multi-dose is defined as a formulation suitable for storage for about 30 days. After complete mixing of the components by way of diffusion or agitation of the device, the closing means can be removed from the first compartment to administer the formulated dose to a patient.
REFERENCES:
patent: 3340873 (1967-09-01), Solowey
patent: 3354883 (1967-11-01), Southerland
patent: 3397694 (1968-08-01), Ogle
patent: 3411503 (1968-11-01), Santomieri
patent: 4330531 (1982-05-01), Alliger
patent: 4331146 (1982-05-01), Brignola
patent: 4412836 (1983-11-01), Brignola
patent: 4950237 (1990-08-01), Henault
patent: 5122117 (1992-06-01), Haber et al.
patent: 5217433 (1993-06-01), Bunin
patent: 5472422 (1995-12-01), Ljungquist
patent: 5630800 (1997-05-01), Blank et al.
patent: 5637100 (1997-06-01), Sudo
Daniel Mark R.
Hunter, Jr. James M.
Merck & Co. , Inc.
Nguyen Anhtuan T.
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