CONTROLLED NON-CLASSIFIED FILLING DEVICE AND METHOD

• US 20170158365A1
• Filed: 02/16/2017
• Published: 06/08/2017
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Dr Py Institute LLC
• Inventors: Py, Daniel
• Granted Patent: US 10,202,214 B2
• Time in Patent Office: Days
• CPC Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 1/1406 Septums, pierceable membranes
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/201 having one piercing end
• 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 2200/10 Coring prevention means, e.g. for plug or septum piecing members
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 5/002 Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics needle protection, e.g. caps, A61M5/3202; for sharps A61B50/3001
• 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: B65B 39/12 movable towards or away from container or wrapper during filling or depositing
• CPC Class Codes: B65B 43/42 Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position by means of filling-nozzles B65B39/00; Supporting containers or receptacles during the filling operation by filling-nozzles B65B39/00
• CPC Class Codes: B65B 55/04 Sterilising wrappers or receptacles prior to, or during, packaging sterilising bottles B67C7/00
• CPC Class Codes: B65B 7/16 Closing semi-rigid or rigid containers or receptacles not deformed by, or not taking-up shape of, contents, e.g. boxes or cartons

Abstract

An injection member penetrates an elastic septum of a device defining a sealed, empty, sterile chamber in fluid communication with the septum. During penetrating, an annular interface is formed between the septum and the injection member extending axially between a penetration point on an interior surface of the septum in fluid communication with the sterile chamber, and an exterior surface of the septum engaging the injection member. The injection member is de-contaminated by (i) friction between the septum and injection member at the annular interface, and (ii) elongation of the septum at the annular interface. A substance is introduced through the injection member and into the sterile chamber of the device, the injection member is then withdrawn from the septum, the septum reseals itself at the resulting penetration aperture, and the chamber is maintained sterile throughout the foregoing steps.

Claims

1. An apparatus comprising:

a housing at least partially defining a processing space;

a device support for releasably holding a sealed device defining a sealed chamber for storing a substance therein, and a penetrable portion in fluid communication with the chamber and penetrable by a filling or injection member;

a conveyor defining a path for transporting the support and the device along the path and through the processing space; and

within the processing space;

a de-contamination station located on the conveyor path and configured to de-contaminate at least the penetrable surface of the penetrable septum;

a filling station located on the conveyor path downstream of the de-contamination station and including at least one filling or injection member coupled or connectable in fluid communication with a source of substance to be filled into the chamber of the device, wherein one or more of (i) the filling or injection member or (ii) the device is movable relative to the other within the filling station to penetrate the penetrable septum with the filling or injection member, introduce substance through the filling or injection member and into the chamber, and withdraw the filling or injection member from the septum;

a resealing station located on the conveyor path downstream of the filling station configured to reseal an aperture formed in the septum during the filling of the chamber of the device at the filling station; and

a cap storage station configured for storing a cap removed from the filling or injection member during filling and resealing of the device.

2. An apparatus as defined in claim 1, further comprising a cap removal device configured to remove the cap from the filling or injection member prior to filling of the device, store the cap in a cap storage station, retrieve the cap from the storage station after filling and resealing of the device, and reapply the cap to the filling or injection member.

3. An apparatus comprising:

a housing at least partially defining a processing space;

a device support for releasably holding a sealed device defining a sealed chamber for storing a substance therein, and a penetrable portion in fluid communication with the chamber and penetrable by a filling or injection member;

a conveyor defining a path for transporting the support and the device along the path and through the processing space; and

within the processing space;

a de-contamination station located on the conveyor path and configured to de-contaminate at least the penetrable surface of the penetrable septum;

a filling station located on the conveyor path downstream of the de-contamination station and including at least one filling or injection member coupled or connectable in fluid communication with a source of substance to be filled into the chamber of the device, wherein one or more of (i) the filling or injection member or (ii) the device is movable relative to the other within the filling station to penetrate the penetrable septum with the filling or injection member, introduce substance through the filling or injection member and into the chamber, and withdraw the filling or injection member from the septum;

a resealing station located on the conveyor path downstream of the filling station configured to reseal an aperture formed in the septum during the filling of the chamber of the device at the filling station; and

a source of substance placeable into and removable from fluid communication with the filling station by a sterile connector that is configured to provide a fluid flow path between the source of substance and the filling station that is sealed from the ambient atmosphere when the source of substance is placed into fluid communication with the filling station and maintains the fluid flow path sealed from the ambient atmosphere when the source of substance is not in fluid communication with the filling station.

4. An apparatus as defined in claim 3, wherein the source of substance comprises a carousel configured to releasable retain one or more substance supply containers.

5. An apparatus as defined in claim 4, wherein each of the one or more substance supply containers contains a different substance or formula.

6. An apparatus as defined in claim 3, further comprising a control disposed between the source of substance and the filling station configured to control the fluid flow between the source of substance and the filling station.

7. An apparatus as defined in claim 3, wherein the fluid flow path is sterile.

8. A method comprising the following step:

(i) conveying a filling or injection member into a filling device, wherein the filling or injection member is housed within a cap and the filling device comprises;

a housing at least partially defining a processing space;

a device support for releasably holding a sealed device defining a sealed chamber for storing a substance therein, and a penetrable portion in fluid communication with the chamber and penetrable by a filling or injection member;

a conveyor defining a path for transporting the support and the device along the path and through the processing space; and

within the processing space;

a de-contamination station located on the conveyor path and configured to de-contaminate at least the penetrable surface of the penetrable septum;

a filling station located on the conveyor path downstream of the de-contamination station and including at least one filling or injection member coupled or connectable in fluid communication with a source of substance to be filled into the chamber of the device, wherein one or more of (a) the filling or injection member or (b) the device is movable relative to the other within the filling station to penetrate the penetrable septum with the filling or injection member, introduce substance through the filling or injection member and into the chamber, and withdraw the filling or injection member from the septum; and

a resealing station located on the conveyor path downstream of the filling station configured to reseal an aperture formed in the septum during the filling of the chamber of the device at the filling station;

(ii) removing the filling or injection member from the cap and fluidly connecting the filling or injection member to a source of substance;

(iii) storing the cap of the filling or injection member in the filling device at a storage position;

(iv) de-contaminating at least a penetrable surface of a device including a needle penetrable portion or septum penetrable by a filling or injection member and a sealed chamber in fluid communication with the penetrable septum;

(v) moving one or more of (a) the filling or injection member or (b) the device relative to the other to penetrate the penetrable septum with the filling or injection member, introducing substance through the filling or injection member and into the chamber, and withdrawing the filling or injection member from the septum; and

(vi) sealing the penetrated region of the septum.

9. A method as defined in claim 8, further comprising the steps of:

(vii) retrieving the cap from the storage position; and

(viii) re-attaching the cap to the filling or injection member.