Semi-automatic reconstituting system for binary oncolytic pharmaceuticals
First Claim
1. A method of preparing a pharmaceutical solution requiring a mixing of first and second liquid components of the pharmaceutical solution for its subsequent intravenous administration comprising the steps of providing syringe structure including a mixing chamber fluidly coupled to first and second ports which are normally sealed from the chamber, and a reciprocating piston in the chamber;
- furnishing first and second closed vials holding the respective components in their interiors;
establishing flow communication which is sealed to a surrounding environment via the first port between the interior of the first vial and the chamber;
flowing the first component into the chamber;
repeating the establishing and flowing steps with the second vial holding the second component to thereby also mix the components and form the solution;
thereafter resealing the first port from the mixing chamber;
providing an I.V. bag and opening flow communication via the second port between the chamber and an interior of the bag;
flowing the pharmaceutical solution from the chamber into an interior of the I.V. bag; and
thereafter resealing the second port from the mixing chamber;
whereby the solution is formed from the components and transferred into the I.V. bag while preventing contact with the components and the solution from the surrounding environment.
1 Assignment
0 Petitions
Accused Products
Abstract
A method and apparatus for preparing a binary liquid, highly toxic cancer treatment pharmaceutical for administration to a patient from an I.V. bag is disclosed. Liquid components of the pharmaceutical are furnished in septum-sealed vials which are mixed in a syringe structure formed by a body having a mixing chamber in fluid communication with first and second ports. The vials are attached to the body at the first port, their septum is pierced, and a normally closed valve between the first port and the chamber is opened so that the liquid components flow along a sealed path into the chamber to prevent contact between the components and the surrounding environment. The I.V. bag is attached to the body at the second port and is pierced by a needle in response to movement of the bag towards the syringe body. This movement is used to open a valve between the second port and the chamber so that the mixed pharmaceutical can be flowed along a sealed path into the I.V. bag to prevent contact between the pharmaceutical and the environment until the transfer of the pharmaceutical to the bag has been completed. The syringe structure is inexpensive, can be injection molded, and is discarded after its use.
40 Citations
37 Claims
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1. A method of preparing a pharmaceutical solution requiring a mixing of first and second liquid components of the pharmaceutical solution for its subsequent intravenous administration comprising the steps of providing syringe structure including a mixing chamber fluidly coupled to first and second ports which are normally sealed from the chamber, and a reciprocating piston in the chamber;
- furnishing first and second closed vials holding the respective components in their interiors;
establishing flow communication which is sealed to a surrounding environment via the first port between the interior of the first vial and the chamber;
flowing the first component into the chamber;
repeating the establishing and flowing steps with the second vial holding the second component to thereby also mix the components and form the solution;
thereafter resealing the first port from the mixing chamber;
providing an I.V. bag and opening flow communication via the second port between the chamber and an interior of the bag;
flowing the pharmaceutical solution from the chamber into an interior of the I.V. bag; and
thereafter resealing the second port from the mixing chamber;
whereby the solution is formed from the components and transferred into the I.V. bag while preventing contact with the components and the solution from the surrounding environment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
- furnishing first and second closed vials holding the respective components in their interiors;
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12. Apparatus for preparing a pharmaceutical solution requiring a mixing of first and second liquid components of the pharmaceutical solution for its subsequent intravenous administration, the apparatus comprising a syringe structure including a mixing chamber in fluid communication with spaced-apart first and second ports on the structure;
- a normally closed valve for each port in fluid communication with the mixing chamber and the respective ports; and
a holder at each port for attaching containers to the syringe structure, each holder including a linearly reciprocable member operatively coupled to the associated valve for opening the valve in response to movement of the member in a first direction and closing of the valve in response to movement of the member in a second, opposite direction;
whereby containers holding the pharmaceutical components can be sequentially connected to the first port for sequentially flowing the components into the chamber and mixing them therein, and a further container can be connected to the second port for flowing the solution from the chamber into the further container. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26)
- a normally closed valve for each port in fluid communication with the mixing chamber and the respective ports; and
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27. Apparatus for preparing and delivering to an I.V. bag a binary liquid cancer treatment pharmaceutical requiring a mixing of first and second liquid components furnished in first and second vials, each vial having an opening closed by a pierceable septum and leading to an interior of the vial, the apparatus comprising:
- a body including an elongated mixing chamber, a piston for drawing liquid into and expulsing liquid from the chamber, and first and second ports on an exterior of the body and in fluid communication with the chamber;
a vial docking cage reciprocably mounted to the body at the first port and comprising a first member mounting a first needle cannula having a pointed free end, a closed end at an interior of the body, and a lateral orifice proximate the closed end and open to an interior of the cannula;
first means biasing the first member away from the body;
a connector adapted to releasably engage and position a vial on the first member so that the pointed free cannula end pierces the septum of the vial to establish flow communication between the vial interior and the cannula interior which is sealed from a surrounding environment;
an elastomeric tubular first valve mounted in the body, in fluid communication with the chamber, surrounding and covering the orifice of the first needle cannula when the cage is relatively remote from the body and uncovering the orifice and thereby establishing fluid communication between the orifice and the chamber when the cage is proximate the body so that retraction of the piston in the chamber draws liquid from the vial interior via the first needle cannula, its orifice and the first valve into the chamber, and movement of the cage induced by the biasing means to the position remote from the body causes the first valve to cover the first orifice to prevent further fluid communication between the first needle cannula and the chamber;
the second port including a needle carrier mounted to the body and movable towards and away from the body, the carrier including a holder for releasably holding the I.V. bag, a second needle cannula having a pointed free needle end for piercing the I.V. bag, a closed end at the interior of the body and a lateral second orifice proximate the closed end communicating with an interior of the second cannula, and second means biasing the carrier into an extended position away from the body; and
an elastomeric tubular second valve mounted in the body, in fluid communication with the chamber, surrounding and covering the second orifice when the carrier is in its extended position, and uncovering the second orifice and thereby establishing fluid communication between the interior of the second cannula and the chamber when the carrier is in a retracted position proximate the body so that movement of the piston into the chamber flows the mixed pharmaceutical from the chamber via the second valve and the second cannula into the I.V. bag. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34, 35, 36)
- a body including an elongated mixing chamber, a piston for drawing liquid into and expulsing liquid from the chamber, and first and second ports on an exterior of the body and in fluid communication with the chamber;
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37. Apparatus for delivering to an I.V. bag a liquid pharmaceutical made from mixed liquid components furnished in separate containers while precluding contact with components and the pharmaceutical, the apparatus comprising a body including a mixing chamber and first and second ports in liquid communication with the chamber;
- a reciprocating holder for alternatingly positioning first and second septum-sealed vials holding the respective components at the first port;
a first needle cannula mounted on the holder for piercing the septum;
a normally closed first valve between the first cannula and the chamber; and
means operatively coupled with the first cannula and the first valve for opening the first valve in response to movement of the holder in a first direction and for closing the first valve in response to movement of the holder in a second direction;
the second port comprising a carrier movable between proximate and remote positions relative to the housing and adapted to releasably engage a sealed, pierceable port of the I.V. bag for receiving the pharmaceutical from the chamber, the carrier including a second needle cannula with a pointed end for piercing the tubular port;
a normally closed second valve between the second cannula and the chamber; and
means operatively coupled with the second cannula and the second valve for opening and closing the second valve in response to movements of the carrier between the proximate and remote positions;
whereby the components are sequentially drawn into the chamber by attaching and detaching the first and second vials to and from the holder, moving the holder to establish and prevent fluid communication between the chamber and the first and second vials and operating the piston, and whereby the pharmaceutical is subsequently transferred to the I.V. bag after the carrier has at least been partially moved between the proximate and remote positions to uncover the orifice in the second cannula so that the mixed liquid pharmaceutical flows from the chamber into the I.V. bag.
- a reciprocating holder for alternatingly positioning first and second septum-sealed vials holding the respective components at the first port;
Specification