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Claims for Patent: 7,806,265

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Claims for Patent: 7,806,265

Title:Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application
Abstract: An apparatus for preparing a pharmaceutical for transient application includes a tray having a sealed compartment, a vial of an ophthalmic formulation of mitomycin-C, a diluent carrier containing sterilized water, and a syringe that are all contained together in a single package. The component parts of the apparatus are used together to reconstitute the contents of the vial with the water in the diluent carrier, and then draw the reconstituted drug into the sealed compartment of the tray by a suction force produced by the syringe. In the tray compartment, the reconstituted drug is absorbed in an absorbent pad. The tray is opened to remove the pad and the absorbed drug from the tray compartment for use of the pad in transient application of the drug.
Inventor(s): Timm; Edward J. (Cumming, GA)
Assignee: Mobius Therapeutics, LLC (St. Louis, MO)
Application Number:11/484,998
Patent Claims: 1. An apparatus for preparation and application of a single dose of an ophthalmic formulation of mitomycin-C comprising: a sealed container containing a single dose of an ophthalmic formulation of mitomycin-C; a sealed container containing sterilized liquid for mixing with the single dose of an ophthalmic formulation of mitomycin-C and preparing the single dose of an ophthalmic formulation of mitomvcin-C for operative use; a means for applying the single dose of an ophthalmic formulation of mitomycin-C prepared with the sterilized liquid to body tissue; the sealed container containing the single dose of an ophthalmic formulation of mitomycin-C, the sealed container containing sterilized liquid, and the means for applying the single dose of an ophthalmic formulation of mitomycin-C prepared with the sterilized liquid to body tissue all being contained as a kit in a single package; a tray having a compartment; at least one absorbent pad provided for positioning in the tray compartment, the pad being provided for containing the single dose of an ophthalmic formulation of mitomycin-C prepared with the sterilized liquid, and the pad being removable from the tray compartment for transient application of the single dose of an ophthalmic formulation of mitomycin-C prepared with the sterilized liquid from the pad; the tray having a cover that is movable between opened and closed positions of the cover relative to the tray where in the opened position the cover is displaced from the tray compartment providing access to the compartment and the pad in the compartment, and in the closed position the cover covers over and seals closed the compartment preventing access to the compartment and the pad in the compartment; a carrier provided for containing the single dose of an ophthalmic formulation of mitomycin-C prepared with sterilized liquid, the carrier being separate from the tray; the tray having a first passage that extends between the tray compartment and an exterior of the tray and is communicatable with the carrier containing the single dose of an ophthalmic formulation of mitomycin-C prepared with sterilized liquid to communicate the single dose of an ophthalmic formulation of mitomycin-C prepared with sterilized liquid from the carrier to the pad in the tray compartment; the tray first passage being removably connectable with the carrier containing the single dose of an ophthalmic formulation of mitomycin-C prepared with sterilized water.

2. The apparatus of Claim 1, further comprising: the sealed container containing a single dose of an ophthalmic formulation of mitomycin-C being a vial, the vial having a top that can be pierced by a needle and seals closed after the needle is removed from the top.

3. The apparatus of claim 2, further comprising: the single dose being one cc.

4. An apparatus for application of a pharmaceutical comprising: the pharmaceutical being a single dose of an ophthalmic formulation of mitomycin-C; a sealed container containing the pharmaceutical; a means for applying the single dose of the ophthalmic formulation of mitomycin-C to body tissue; a tray having a compartment; at least one absorbent pad in the tray compartment, the pad containing the pharmaceutical, and the pad being removable from the tray compartment for transient application of the pharmaceutical from the pad; the tray having a cover that is movable between opened and closed positions of the cover relative to the tray where in the opened position the cover is displaced from the tray compartment providing access to the compartment and the pad in the compartment, and in the closed position the cover covers over and seals closed the compartment preventing access to the compartment and the pad in the compartment; a carrier containing the pharmaceutical, the carrier being separate from the tray; the tray having a first passage that extends between the tray compartment and an exterior of the tray and is communicatable with the source of the pharmaceutical to communicate the pharmaceutical from the source to the pad in the tray compartment; and; the tray first passage being removably connectable with the carrier containing the pharmaceutical; a source of a suction force that is separate from the tray; and, the tray having a second passage that is separate from the first passage and extends between the tray compartment and the exterior of the tray and is communicatable with the source of the suction force to communicate the suction force from the source of the suction force to the tray compartment and the tray first passage.

5. The apparatus of claim 4, further comprising: a syringe that operates as the source of the suction force, the syringe being removably connectable to the second passage of the tray.

6. The apparatus of claim 5, further comprising: a vial containing the pharmaceutical, the vial being separate from the tray and the carrier and being connectable to the carrier to communicate the pharmaceutical contained in the vial to the carrier and to the tray compartment.

7. The apparatus of claim 6, further comprising: the carrier containing a liquid that reconstitutes the pharmaceutical communicated from the vial to the carrier.

8. An apparatus for preparation and application of a single dose of an ophthalmic formulation of mitomycin-C comprising: a tray having a compartment in the tray; an absorbent pad in the tray compartment, the pad being removable from the compartment; a carrier containing a single dose of an ophthalmic formulation of mitomycin-C, the carrier being connectable to the tray to communicate the single dose of an ophthalmic formulation of mitomycin-C to the compartment and to communicate the single dose of an ophthalmic formulation of mitomvcin-C to the pad to be absorbed by the pad, whereby the pad with the single dose of an ophthalmic formulation of mitomycin-C absorbed by the pad are removable from the tray compartment for transient application of the single dose of an ophthalmic formulation of mitomvcin-C from the pad; the tray, the absorbent pad and the carrier all being contained as a kit in a single package; and a syringe that is connectable to the tray to communicate the syringe with the tray compartment, the syringe being operable to produce a suction force that is communicated to the tray compartment and to the carrier connected to the tray to draw the single dose of an ophthalmic formulation of mitomycin-C from the carrier into the tray compartment.

9. The apparatus of claim 8, further comprising: the tray having a cover that covers over and seals the tray compartment and is movable from the tray compartment to provide access to the compartment and enable removing the pad from the compartment.

10. The apparatus of claim 9, further comprising: a vial containing the single dose of an ophthalmic formulation of mitomycin-C that is connectable to the carrier to communicate the single dose of an ophthalmic formulation of mitomycin-C to the carrier.

11. An apparatus for application of a pharmaceutical comprising: a tray having a body with an exterior surface and a cavity recessed into the exterior surface, the cavity forming a compartment inside the tray that has a compartment interior volume and a compartment opening through the tray exterior surface that provides access to the compartment interior volume, the tray also having a first passage and a second passage that are separate from each other and from the compartment opening and that extend through the tray to the compartment and communicate the compartment interior volume with an exterior environment of the tray; at least one absorbent pad in the compartment interior volume, the at least one pad being a pharmaceutical transient application pad; a diluent carrier having an interior bore containing a diluent liquid, the diluent carrier being connectable to the tray first passage to communicate the interior bore through the first passage with the tray compartment interior volume; a pharmaceutical container containing a pharmaceutical, the pharmaceutical container being connectable to the diluent carrier to communicate the pharmaceutical in the pharmaceutical container with the diluent in the diluent carrier; and, a suction device that is operable to produce a vacuum suction force, the suction device being connectable to the tray second passage to communicate the suction device through the second passage with the tray compartment interior volume, whereby operation of the suction device produces a vacuum suction force that is communicated through the tray second passage, the tray compartment and the tray first passage to the diluent carrier connected to the tray.

12. The apparatus of claim 11, further comprising: the pharmaceutical being a single dose of an ophthalmic formulation of mitomycin-C.

13. The apparatus of claim 11, further comprising: the tray having a cover that is movable between opened and closed positions of the cover relative to the tray where in the opened position the cover is displaced from the tray compartment providing access to the compartment and the pad in the compartment, and in the closed position the cover covers over and seals closed the compartment preventing access to the compartment and the pad in the compartment.

14. The apparatus of claim 13, further comprising: the tray, the carrier, the pharmaceutical container, and the syringe being packaged together as a kit.
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