Automatic liquid drug preparation apparatus for the preparation of a predetermined dosage of liquid drug

• US 8,316,898 B2
• Filed: 05/04/2008
• Issued: 11/27/2012
• Est. Priority Date: 05/02/2007
• Status: Expired due to Fees

• Current Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Zinger, Freddy, Denenburg, Igor, Lev, Amir
• Primary Examiner(s): Maust, Timothy L
• Assistant Examiner(s): BELL III, ROBERT L
• Application Number:
  US12/598,469
• Publication Number:
  US 20100087786A1
• Time in Patent Office: 1,668 Days
• Field of Search: 141/27, 141/97, 141/192, 141/198, 141/319, 141/329, 141/330, 604/224, 604/246
• US Class Current: 141/27
• CPC Class Codes: A61J 1/2031 having openings brought into alignment
• CPC Class Codes: A61J 1/2055 having gripping means
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/3128 Incorporating one-way valves, e.g. pressure-relief or non-return valves
• CPC Class Codes: A61M 2039/042 Shrouds encircling the access needle preventing accidental needle-stick
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/204 connected to external reservoirs for multiple refilling
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing

Abstract

Automatic liquid drug preparation apparatus for preparing a liquid drug assemblage with a predetermined dosage of liquid drug. The liquid drug assemblage is prepared from a preparatory assemblage including a fluid control device having a body member with a syringe port, a vial adapter, and an administration port, a vial pre-filled with powder or liquid medicament, and a syringe pre-filled with diluent for mixing with the medicament. The automatic liquid drug preparation apparatus includes a housing, a cradle for receiving the preparatory assemblage, and a controller for controlling a motorized syringe drive unit for selectively transferring liquid contents between the syringe and the vial, a motorized cradle drive unit for selectively rotating the cradle relative to the housing, and a motorized vial adapter release unit for selectively detaching the vial adapter with its attached spent vial from the body member to form the liquid drug assemblage.

Claims

1. Automatic liquid drug preparation apparatus for preparing a predetermined dosage of liquid drug for administration,

the apparatus intended for use with a preparatory assemblage with liquid drug constituents for processing into a liquid drug assemblage with the predetermined dosage, of liquid drug,

the preparatory assemblage including a fluid control device, a vial prefilled with a medicament and having a vial longitudinal axis, and a syringe with a syringe longitudinal axis and having a syringe end wall with an inside surface and a reciprocal plunger with a proximal plunger head and a distal plunger tip, the syringe being pre-filled with diluent for mixing with the medicament,

the fluid control device including a body member having a syringe port for receiving the syringe, a vial adapter having a downward depending skirt with a plurality of upright slits defining flex members for snap fitting onto the vial, and

a drug administration port for administrating the liquid drug,

the vial adapter and the vial attached thereto being detachable from the body member on rotation with respect thereto,

the fluid control device having a mixing flow path between the syringe port and the vial adapter and an administration flow path between the syringe port and the drug administration port,

the apparatus comprising:

(a) a housing;

(b) a cradle for manual insertion of the preparatory assemblage thereinto; and

(c) a controller for controlling the operation of

(i) a motorized syringe drive unit for selectively reciprocating a plunger head drive member engaging the plunger head for reciprocating the plunger relative to the fluid control device for transferring liquid contents between the syringe and the vial when the syringe longitudinal axis is perpendicular to the vial longitudinal axis,

(ii) a motorized cradle drive unit for selectively rotating said cradle with the preparatory assemblage about the syringe longitudinal axis relative to an initial upright position in said housing, and

(iii) a motorized vial adapter release unit for selectively rotating the vial adapter about the vial longitudinal axis relative to the body member for detaching the vial adapter and its attached spent vial from the body member.

2. Apparatus according to claim 1 wherein said controller executes a syringe linear encoder reset procedure to reset a syringe linear encoder for determining the location of the syringe'"'"'s plunger relative to the syringe'"'"'s barrel for enabling aspiration of the predetermined dosage of liquid drug.

3. Apparatus according to either claim 1 wherein said controller operates said cradle drive unit to rotate said cradle and the preparatory assemblage to a substantially inverted position and operates said syringe drive unit to execute a trapped air displacement procedure involving the repeated transfer of liquid drug contents between the syringe and the vial for entraining air bubbles initially entrapped in the mixing flow path between the syringe and the vial therewith for fragmenting the air bubbles into smaller air bubbles for being progressively added to the vial'"'"'s air volume thereby progressively reducing the accumulated air bubble volume in the liquid drug contents.

4. Apparatus according to claim 3 wherein said trapped air displacement procedure includes an initial series of long strokes of the plunger of the syringe and a subsequent series of short strokes of the plunger of the syringe.

5. Apparatus according to claim 1 wherein said controller operates said cradle drive unit for rotating said cradle and the preparatory assemblage through near 90°

relative to said upright position to a near horizontal position and operates said syringe drive unit to inject the diluent from the syringe into the vial.

6. Apparatus according to claim 1 and further comprising a hinged cover for covering the preparatory assemblage and a cover safety mechanism for preventing operation of the apparatus on detection said cover is not fully closed.

7. Apparatus according to claim 6 wherein said cover is hinged on said cradle whereby said cradle and said hinged cover are rotatable relative to said housing.

8. Apparatus according to claim 1 wherein said syringe drive unit initially urges said plunger head drive member against the plunger head for displacing the plunger toward the fluid control device whereupon, on abutment of the plunger tip against the syringe'"'"'s end wall, said plunger head drive member engages the plunger head.

9. Apparatus according to claim 8 wherein said plunger head drive unit is constituted by a flipper arrangement with a pair of flippers biased towards one another whereupon said pair of flippers initially pivot outwards and subsequently snap fit onto the plunger head on abutment of the plunger tip against the syringe'"'"'s end wall.

10. Apparatus according to claim 1 wherein said vial adapter release unit includes an annular vial adapter gripper for encircling the vial adapter on manual insertion of the preparatory assemblage into said cradle, said vial adapter gripper including at least one flexible leaf spring with an upright section having a radial inwardly protruding tab for insertion into an upright slit of the vial adapter'"'"'s plurality of upright slits for enabling the detachment of the vial adapter from the body member on rotation of the vial adapter relative to the body member.

11. Apparatus according to claim 1 wherein said vial adapter release unit includes a vial adapter release mechanism for selectively raising the vial adapter and its attached spent vial on detachment of the vial adapter from the body member thereby assisting a user to manually remove the vial adapter and its attached spent vial from said cradle.

12. Apparatus according to claim 11 wherein said vial adapter release mechanism includes a rotatable annular member in screw thread arrangement with an open topped upright cylindrical vial holder linearly displaceable with respect to said annular member on rotation of said annular member.

13. Apparatus according to claim 1 wherein said housing includes a blind bore for insertion of a vial for assisting a user to assemblage a preparatory assemblage.

14. Apparatus according to claim 1 wherein said housing includes a V-shaped opener for assisting a user to remove a needle shield from a liquid drug assemblage including a needle with a needle shield.