Compounding systems and methods for safe medicament transport

• US 9,877,895 B2
• Filed: 08/04/2014
• Issued: 01/30/2018
• Est. Priority Date: 08/02/2013
• Status: Active Grant

• Current Assignee: Cormed Ltd.
• Original Assignee: J&J Solutions, Inc.
• Inventors: Garfield, Jared, Lyon, Gregory
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US14/908,169
• Publication Number:
  US 20160206511A1
• Time in Patent Office: 1,275 Days
• Field of Search: 141319, 141329
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/2003 Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2072 for internal venting
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 5/31 Details
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like
• CPC Class Codes: B65B 3/12 mechanically, e.g. by pistons or pumps
• CPC Class Codes: B65B 3/28 by weighing
• CPC Class Codes: B65B 63/08 for heating or cooling articles or materials to facilitate packaging

Abstract

An automatic or semi-automatic preparation system and process is provided for forming a medicament solution from a vial containing one of a liquid and a non-liquid material.

Claims

1. An automatic or semi-automatic preparation system for forming a medicament solution from a vial containing one of a liquid and a non-liquid material, the preparation system comprising:

a carousel configured to provide three axes of motion, the carousel including a manipulator having;

at least one first rail defining a first axis;

at least one second rail defining a second axis, the second axis being oriented orthogonal to the first axis;

at least one third rail defining a third axis, the third axis being oriented orthogonal to the each of the first axis and the second axis;

a first gear belt movably supported on at least one of the first rails, the second rails or the third rails, wherein the first gear belt, the first gear belt is movably supported on a series of sprockets;

a second gear belt movably supported on at least one of the first rails, the second rails or the third rails, wherein the second gear belt, the first gear belt is movably supported on a series of sprockets;

the first gear belt and the second gear belt being spaced apart from one another and being arranged in parallel with one another;

at least one component holder supported on at least one of the first gearbelt and the second gear belt, each component holder being configured to selectively hold a syringe, a vial, a syringe adapter or a vial adapter; and

at least one of a rotation station, a transfer station, and a weigh station disposed about the carousel;

wherein the rotation station is configured for inverting and reverting a syringe and vial assembly;

wherein the transfer station is configured for transferring material from a vial to a syringe; and

wherein the weigh station is configured for weighing at least one of the syringe, the vial, and the syringe and vial assembly.

2. The preparation system according to claim 1, wherein the first gearbelt is movable in a first plane defined by the first axis that is defined by the first rail and the second axis that is defined by the second rail.

3. The preparation system according to claim 2, wherein the second gearbelt is movable in a second plane defined by the first axis that is defined by the first rail and the second axis that is defined by the second rail, the second plane being parallel to the first plane and being spaced a distance therefrom.

4. The preparation system according to claim 3, wherein at least one component holder is movable along the third axis, between the first plane and the second plane.

5. The preparation system according to claim 1, further comprising:

at least one syringe adapter manipulatable by a component holder of the carousel, each syringe adapter including;

a body portion defining a lumen therethrough; and

a seal member connected to a distal end of the body portion and extending across the lumen thereof; and

at least one vial adapter connectable to a neck of a vial and configured to receive the body portion of the syringe adapter, the vial adapter including;

a base having at least one retainer configured to engage the neck of the vial, the base defining an opening having a seal member disposed therewithin;

a stem extending from the base, the stem defining a lumen therethrough and being in operative communication with the opening of the base, the stem defining an opening through a wall thereof;

a needle shuttle valve slidably disposed within the lumen of the stem, the needle shuttle valve forming a fluid tight seal with the stem, the needle shuttle valve supporting a transfer needle such that the transfer needle extends from a first and a second end thereof and supporting a vacuum needle such that the vacuum needle extends from the first end of the needle shuttle valve; and

a vacuum cup slidably supported on the stem, the vacuum cup being in fluid tight contact with the stem and with the base, wherein a vacuum chamber is defined in the space between the base, the stem and the vacuum cup, the vacuum chamber being in fluid communication with the lumen of the stem through the opening formed in the wall of the stem.

6. The preparation system according to claim 5, further comprising a transfer station having a first condition in which the needle shuttle valve of the vial adapter is in a retracted position such that the transfer needle and the vacuum needle do not extend through the seal member of the base of the vial adapter, and the vacuum cup is in an advanced position such that the volume of the vacuum chamber is at a minimum.

7. The preparation system according to claim 6, wherein the transfer station has a second condition in which the body portion of the syringe adapter is advanced through the lumen of the stem such that the second end of the transfer needle penetrates through the seal member of the body portion and the needle shuttle valve is advanced through the lumen of the stem to penetrate the first end of the transfer needle and a tip of the vacuum needle through the seal member of the vial adapter, and wherein the vacuum needle is brought into fluid communication with the opening formed in the wall of the stem.

8. The preparation system according to claim 7, wherein the transfer station has a third condition in which the vacuum cup is moved to a proximal position thereby enlarging the vacuum chamber and drawing a vacuum through the vacuum needle.

9. The preparation system according to claim 8, wherein the carousel is configured to connect a syringe adapter to a syringe, and to transport the assembled syringe and syringe adapter to a vial having a vial adapter connected thereto.

10. The preparation system according to claim 9, wherein the carousel is configured to connect the syringe adapter, that is connected to the syringe, to the vial adapter, that is connected to the vial.

11. The preparation system according to claim 1, wherein a component holder includes a gripper having:

a first pair of fixed, spaced apart jaws, the first pair of jaws including a first jaw and a second jaw; and

a second pair of fixed, spaced apart jaws, the second pair of jaws including a first jaw and a second jaw;

wherein the first pair of jaws is translatable relative to the second pair of jaws; and

wherein the first jaw of the first pair of jaws is interposed between the second pair of jaws, and the second jaw of the second pair of jaws is interposed between the first pair of jaws.

12. The preparation system according to claim 11, wherein operation of the gripper includes translation of the first pair of jaws relative to the second pair of jaws to grip a component at:

a first gripping position located between the first jaw of the first pair of jaws and the first jaw of the second pair of jaws;

a second gripping position located between the second jaw of the first pair of jaws and the first jaw of the second pair of jaws; and

a third gripping position located between the second jaw of the first pair of jaws and the second jaw of the second pair of jaws.

13. The preparation system according to claim 12, wherein the first pair of jaws supports a rack, and the second pair of jaws supports a rack, and wherein a pinion interconnects the each rack, wherein rotation of the pinion results in axial translation of the first pair of jaws and the second pair of jaws relative to one another.

14. The preparation system according to claim 12, further comprising an error trapping protocol to check and confirm that correct components are being manipulated about the carousel relative to one another,

wherein, for a particular stage in the process, the error trapping protocol compares a known dimension of a component expected in the gripper against a real-time dimension of a components gripped within the gripper, and triggers an alert when a known expected dimension for the component is different than a real-time measured dimension of the component that is present in the gripper.