System and method for mixing parenteral nutrition solutions

• US 5,037,390 A
• Filed: 12/28/1989
• Issued: 08/06/1991
• Est. Priority Date: 12/28/1989
• Status: Expired due to Term

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: Burron Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Inventors: Raines, Kenneth, Horner, Gary
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US07/458,418
• Time in Patent Office: 586 Days
• Field of Search: 604/407, 604/411, 604/80-86, 604/246, 604/248, 248/311.2, 248/311.3, 211/204, 211/74
• US Class Current: 604/83
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2433 Valve comprising a resilient or deformable element, e.g. flap valve, deformable disc
• CPC Class Codes: A61M 2039/2466 being fixed in its center
• CPC Class Codes: A61M 2039/2493 Check valve with complex design, e.g. several inlets and outlets and several check valves in one body
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

An apparatus and method for mixing parenteral nutrition solutions from additives in a plurality of vials containing the additives, in which a vented spike is inserted through a disposable rack and into the stoppered end of each vial, with the vials secured on the rack. The rack is engaged on a stand through a quick release fitting, and maintains the vials in a vertical orientation with the labels clearly visible. A dedicated syringe is connected with each vial in aligned relationship therewith through a unique two-way valve which is mounted to a manifold. In one form of the invention, the valve is attached directly on the manifold to reduce dead space volume and consequently reduce residual fluid in the system between purges. A flushing system is attached to one end of the manifold to flush any residual fluids into the final container at the end of a transfer process. The other end of the manifold may be attached in tandem with a further manifold in a further apparatus containing additional vials for admixing even further additives.

Claims

1. An apparatus for preparing parenteral nutrition solutions from a plurality of additives contained in individual vials having sealed ends, comprising:

a rack for supporting the vials in a predetermined relationship adjacent one another, said rack having means thereon for contacting and supporting said vials in said predetermined relationship, and having quick release means for releasable attachment of said rack on a stand, said rack further having openings therethrough aligned with the positions of said vials on said rack means;

means for piercing the sealed ends of said vials to gain access to the contents thereof, through a respective opening in the rack means and into the sealed end of an associated vial, the piercing means being held on one side of the rack and an associated vial being held on the other side, said piercing means including means for attachment thereto of a pump for withdrawing additive from the associated vial, wherein an individual pump is held in associated, aligned relationship with each vial, whereby a plurality of vials and associated piercing means may be assembled to said rack and the assembly of the rack, the vials and the piercing means releasably atached to a stand, wherein;

said rack comprises an elongate, rectangularly shaped, flat bar, said openings being spaced along the length of the bar, said means for contacting and supporting the vials comprises upstanding cylindrical walls on a top surface of the bar, and said quick release means comprises key-hole shaped openings through the opposite ends of the bar; and

said stand includes a pair of elongate arms projecting in a common direction from a base, said arms having headed ends for engagement in said key-hole shaped openings and being flexible to align the headed ends with the larger part of the key-hole shaped openings whereby the headed ends may be passed through the key-hole shaped openings to enable the bar to be attached to and removed from the arms.

2. An apparatus as claimed in claim 1, wherein:

the containers of additives comprise vials each having a stoppered end;

said means for accessing the contents of the containers includes a piercing spike having a piercing end for penetrating the stoppered end;

said pump means each comprises a syringe attached to a respective piercing spike;

a manifold means is connected with the syringes to receive the additives from the syringes attached to the respective vials;

a multi-way valve means is connected with each syringe to control flow from the associated vial, to the syringe and thence into the manifold;

said multi-way valve means comprises a valve body having a first one-way valve to enable flow from a vial into the associated syringe but prevent reverse flow from the syringe into the vial, and a second one-way valve to enable flow from the syringe into the manifold but prevent reverse flow from the manifold to the syringe, said one-way valves being constructed and positioned relative to the manifold so as to minimize residual material in the apparatus; and

a flushing means is connected with the manifold means to flush any residual material from the manifold means following transfer of an additive from its container to the final solution container.

3. A method of mixing a plurality of additives to produce a parenteral nutrition solution, comprising the steps of:

supporting a plurality of vials containing the additives in predetermined relationship to one another;

attaching a plurality of pump means in predetermined aligned relationship with the vials so that a pump means is provided for each vial and is held in aligned relationship thereto;

using the pump means to successively draw the additives from the vials and expel the additives into and through a manifold to a container for the parenteral nutrition solution; and

flushing the manifold with a flushing solution to remove any residual additives from the manifold following a mixing procedure.

4. A method as claimed in claim 3, including the steps of:

supporting the vials and pump means on a disposable rack; and

releasably attaching the rack to a stand, said vials and pump means being assembled to the rack after to attachment of the rack to the stand.