Method For Powdered Drug Reconstitution

• US 20140358272A1
• Filed: 12/03/2012
• Published: 12/04/2014
• Est. Priority Date: 12/02/2011
• Status: Active Grant

• Current Assignee: Omnicell Incorporated
• Original Assignee: Aesynt Topco B.V
• Inventors: Fioravanti, Fabio, Bianco, Walter, Marinkovic, Sasa, Kucich, Gabriele
• Granted Patent: US 9,804,586 B2
• Time in Patent Office: Days
• US Class Current: 700/117
• CPC Class Codes: A61J 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: B01F 21/00 Dissolving separating by dissolving B01D; dissolving to effect cooling F25D5/00
• CPC Class Codes: B01F 21/02 Methods
• CPC Class Codes: B01F 21/30 Workflow diagrams or layout of plants, e.g. flow charts; Details of workflow diagrams or layout of plants, e.g. controlling means
• CPC Class Codes: B01F 2101/22 Mixing of ingredients for pharmaceutical or medical compositions
• CPC Class Codes: B01F 31/10 with a mixing receptacle rotating alternately in opposite directions
• CPC Class Codes: B01F 31/201 Holders therefor
• CPC Class Codes: B01F 31/22 with supporting means moving in a horizontal plane, e.g. describing an orbital path for moving the containers about an axis which intersects the receptacle axis at an angle
• CPC Class Codes: B01F 31/25 the containers being submitted to a combination of movements other than within a horizontal plane, e.g. rectilinear and pivoting movement with a receptacle submitted to a combination of movements, i.e. at least one movement being vibratory or oscillatory B01F31/50
• CPC Class Codes: B01F 31/44 with stirrers performing an oscillatory, vibratory or shaking movement B01F31/40, B01F31/42 take precedence
• CPC Class Codes: B01F 35/2207 Use of data, i.e. barcodes, 3D codes or similar type of tagging information, as instruction or identification codes for controlling the computer programs, e.g. for manipulation, handling, production or compounding in mixing plants B01F33/848 takes precedence
• CPC Class Codes: B01F 35/422 having a jaw-type or finger-type shape
• CPC Class Codes: G05B 19/4155 characterised by programme execution, i.e. part programme or machine function execution, e.g. selection of a programme
• CPC Class Codes: Y10S 901/02 Arm motion controller

Abstract

Method of robot control is disclosed that includes the steps of: providing a user interface for introducing data indicative of a drug to be subjected to a reconstitution process; accessing an internal data base for outputting, for a selected drug, a list of primitive movements P1, P2, . . . Pi, . . . Pn to be used in the reconstructing process; operating the robot for executing sequentially the primitives and moving a container according to the instructions of the primitives; measuring, during the movement of the container under robot action, physical positions in the space and dynamic parameters of the container creating a list of registered data; comparing the measured positions in the space and the dynamic parameter with the corresponding ones of the primitive movements for selecting a list of eligible primitives if a sufficient approximation level is reached; elaborating selected eligible primitives together to generate instructions for the robot allowing a complex movement encompassing the simple movements; and using the robot for shaking the container according to the complex movement.

Claims

1. A method of control of a robot (2) having a movable element for carrying a container (3) elongated along one axis (H) and holding a pulverized drug (4) and diluents (5);

said robot (2) being designed to agitate the container for enabling a reconstruction process wherein the pulverized drug is fully dissolved in the diluents, the method comprising the following steps;

providing a user interface (22) for introducing data indicative of the drug to be subjected to reconstitution process;

accessing to an internal data base (DB) based on said introduced data for outputting, for a selected drug, a list of primitive movements P1, P2, . . . Pi, . . . Pn to be used in said reconstructing process;

each primitive movement including the computerized instruction for the robot in order to move the container according to a pre-determined trajectory that, in three dimensional space, defines a predefined simple movement that mimics a movement made under manual reconstitution;

operating the robot (2) for executing sequentially the primitives that have been outputted and moving the container (3) according to the instructions of the primitives;

measuring, during the movement of the container under robot action, physical positions in the space and dynamic parameters of the container (3) creating a list of registered data;

comparing the measured positions in the space and the dynamic parameter with the corresponding ones of the primitive movements for selecting a list of eligible primitives if a sufficient approximation level is reached;

elaborating selected eligible primitives together to generate instruction for the robot allowing a complex movement encompassing said simple movements; and

using said robot (2) for shaking said container that is moved in the space according to said complex movement.

2. Method according to claim 1, wherein said data base (DB) provides for each primitive movement a list of constraints.

3. Method according to claim 1, further comprising the step of definition of a number of kinematic parameters that are related to any selected primitive before operating the robot (2) for executing sequentially the primitives;

the method further comprising the step of

modifying said kinematic parameters if the approximation level is not reached; and

operating the robot for executing the primitives with updated kinematic parameters.

4. Method as defined in claim 1, wherein the list of said primitive comprises two or more of the following primitives movement:

Primitive movement P1 (NONE) in which the elongated container (3) containing the drug is shacked by the robot (2) along a trajectory comprising first direction D1 parallel to its main axis H and a second direction D2 perpendicular to the first direction D1 without applying any further revolution or rotary movement to the container (3) during the above translation;

Primitive movement P2 (SWEEP_CONE) in which the axis H of the container moves along a trajectory that rest on the surface of a cone, and wherein the angular speed of the rotating container 3 may be constant, sinusoidal or have a saw tooth profile;

the cone is swept entirely or limited to an arc;

Primitive movement P3 (SWEEP_CYLINDER) in which the axis H of the container moves along a trajectory that rests on the surface of a cylinder, wherein the angular speed of the rotating container may be constant, sinusoidal or have a saw tooth profile; and

wherein the cone is swept entirely or limited to an arc;

Primitive movement P4 (CUSTOM) in which the axis H of the container moves along a trajectory that rests on a parametric custom surface defined in the 3D space;

Primitive movement P5 (PENDULUM_—

AXIS) in which the axis H is subject to a pendular rotating movement on a variable plane;

wherein the container (3) may be subject to an angular speed that may be constant, sinusoidal or follow a saw tooth profile; and

wherein rotation around the rotation axis of the robot can be limited to an arc.

5. Method according to claim 2, wherein constraint may comprise one or more of the following:

constraints indicative of limit positions that robot parts (2) or container (3) must not exceed during the reconstitution phase;

maximum speed values that parts of the robot (2) or container (3) must not exceed, during the reconstitution phase;

maximum inclination angles that parts of the robot (2) or container (3) must not exceed, during the reconstitution phase;

maximum acceleration values that parts of the robot (2) or container (3) must not exceed, during the reconstitution phase.

6. Method according to claim 1, wherein the primitive movements are created in a setting phase wherein:

inertial measuring means (IM) are coupled with the container (3) to measure the movements of the container (3) while a trained operator manually holds and shakes the container to effect a reconstitution phase according to a predetermined protocol;

said inertial measuring means measure positions and dynamic parameters that describe a three dimensional drug-reconstitution movement for the reconstitution of the drug;

analyzing said three dimensional drug-reconstitution movement to extracts primitive movements that approximate the single movements that the operator has manually operated.

7. Method according to claim 1, wherein elaborating said primitives together involves at least one of the following actions:

a) setting the number of repetition of each primitive;

b) setting a possible contemporaneous execution of two or more primitives at the same time;

c) setting the pause between two adjacent primitives;

d) setting the number of repetition of the whole list of primitives.