Formulation of pharmaceutical solutions in free fall

• US 5,941,867 A
• Filed: 05/08/1998
• Issued: 08/24/1999
• Est. Priority Date: 07/15/1997
• Status: Expired due to Term

• Current Assignee: Mark Levy & Associates, PLLC
• Original Assignee: Ti Kao
• Inventors: Kao, Ti
• Primary Examiner(s): Stright, Jr., Ronald
• Assistant Examiner(s): GRING, NOELLE K
• Application Number:
  US09/075,145
• Time in Patent Office: 473 Days
• Field of Search: 604/82, 604/83, 604/84, 604/85, 604/87, 604/89, 604/403, 604/408, 604/405, 604/406, 604/410, 604/416, 604/903, 604/500, 221/636, 221/91, 221/2
• US Class Current: 604/416
• CPC Class Codes: A61J 1/067 Flexible ampoules, the contents of which are expelled by squeezing
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe

Abstract

Sterile solutions containing pharmaceuticals suitable for use in low and micro-gravity environments are prepared with unit dose pharmaceutical dispensers having a pre-measured quantity of medicament. A compressed air reservoir may be activated to rupture the dispenser and positively expel the unit dose into solution. This can be accomplished by inverting a bag containing the pharmaceutical or by operation of a piston which pushes all the pharmaceutical from the dispenser. A robot either places the pharmaceutical dispensers inside a mixing chamber or connects the dispensers to the mixing chamber, which comprises a flexible bag expandable to receive sterile water and pharmaceuticals. The mixing chamber may collapse under cabin pressure to drive prepared solutions from the chamber through a sterilization filter into an intravenous bag or dispensing unit. Sterile water or saline solution is contained in pre-measured dispensing units employing similar principles to the pharmaceutical dispensers, with a positive expulsion bladder similar to that employed in a zero gravity fuel tank. A robotic, manually activated, or squib-activated valve injects a pre-determined quantity of air into the solution container, where the air expands again a membrane or the surface of the fluid, causing it to flow through a check valve into the mixing container. The mixing container is mounted on a vibrating arm driven by a rotary electric motor or a piezoelectric motor which causes agitation until the mixture is uniformly mixed. A sensor may monitor the progress of dissolution of the pharmaceutical suspension through observing optical index of refraction.

Claims

1. A method for remotely preparing solutions for administration to humans comprising the steps of:

extracting a mixing bag from a store of mixing bags;

introducing a container of a predetermined amount of a medicament into the mixing bag in response to a remotely transmitted signal;

introducing water into the mixing bag from an attached liquid supply bag;

breaking the container to eject the medicament into the mixing bag;

mixing the water and the medicament to form a solution; and

detecting the degree of mixing of the medicament and the water by a sensor positioned exterior to the mixing bag;

after a desired level of mixture has been obtained as detected by the sensor, applying negative pressure to a second bag connected to the mixing bag through a filter to draw a filtered solution into the second bag.

2. The method of claim 1 further comprising the steps of:

transmitting a radio signal containing instructions as to which solution to prepare; and

receiving the transmitted signal at a location remote from the location from which it was transmitted, and performing the steps of claim 1 in response to the instructions.

3. The method of claim 1 wherein the step of introducing water into the mixing bag comprises actuating a valve interposed between the supply bag and the mixing bag and applying pressure to the supply bag.

4. The method of claim 1 wherein the means for drawing the solution from the mixing bag comprises a negative pressure chamber enclosing the administration bag.

5. The method of claim 1 wherein the step of breaking the container comprises rupturing the container prior to its introduction into the mixing bag.

6. The method of claim 1 wherein the step of breaking the container comprises engaging the container within the bag to rupture the container and discharge the contents therefrom.

7. The method of claim 1 further comprising the steps of:

preserving the mixing chamber and broken container after administration of the solution to a patient;

reviewing the contents of the mixing chamber at a time subsequent to the preparation of the solution to verify the contents of the solution administered to the patient.

8. The method of claim 1 further comprising the step of visually identifying the contents of the mixing chamber after the preparation of the solution to determine the contents of the solution.

9. The method of claim 1 wherein the mixing step further comprises engaging a portion of the mixing bag and mechanically agitating it.

10. A method for remotely preparing solutions for administration to humans comprising the steps of:

extracting a mixing bag from a store of mixing bags;

introducing a container of a predetermined amount of a medicament into the mixing bag in response to a remotely transmitted signal;

introducing water into the mixing bag from an attached liquid supply bag;

breaking the container to eject the medicament into the mixing bag;

mixing the water and the medicament to form a solution;

applying negative pressure to a second bag connected to the mixing bag through a filter to draw a filtered solution into the second bag; and

detecting the signals from an electric eye positioned to view the mixing bag, and halting the introduction of water into the mixing bag when the level detected by the electric eye satisfies a predetermined value.

11. A method for remotely preparing solutions for administration to humans comprising the steps of:

extracting a mixing bag from a store of mixing bags;

introducing a container of a predetermined amount of a medicament into the mixing bag in response to a remotely transmitted signal;

introducing water into the mixing bag from an attached liquid supply bag;

breaking the container to eject the medicament into the mixing bag;

mixing the water and the medicament to form a solution; and

applying negative pressure to a second bag connected to the mixing bag through a filter to draw a filtered solution into the second bag;

wherein the mixing step comprises agitating a ferromagnetic metal bar positioned within the mixing bag by rotating a magnetic element exterior to the mixing bag.