Controlled non-classified filling device and method

• US 10,202,214 B2
• Filed: 02/16/2017
• Issued: 02/12/2019
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Dr Py Institute LLC
• Original Assignee: Dr Py Institute LLC
• Inventors: Py, Daniel
• Primary Examiner(s): Niesz, Jason K
• Application Number:
  US15/434,468
• Publication Number:
  US 20170158365A1
• Time in Patent Office: 726 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 support for releasably holding at least one device defining an interior sealed from ambient atmosphere and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula;

a conveyor defining a path for transporting the support and the at least one 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 an exterior portion of the elastic member;

a dispensing station located on the conveyor path downstream of the de-contamination station and including at least one piercing or penetrating member or cannula coupled or connectible in fluid communication with a source of substance to be dispensed into the interior of the at least one device, wherein one or more of (i) the at least one piercing or penetrating member or cannula or (ii) the at least one device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member;

a sealing station located on the conveyor path downstream of the dispensing station configured to hermetically seal the interior from ambient atmosphere; and

a cap storage configured for storing a cap removed from the at least one piercing or penetrating member or cannula during dispensing of substance into and sealing of the interior.

2. An apparatus as defined in claim 1, further comprising a cap removal device configured to remove the cap from the at least one piercing or penetrating member or cannula prior to dispensing of substance into the device, store the cap in the cap storage, retrieve the cap from the cap storage after dispensing of substance into and sealing of the device, and reapply the cap to the at least one piercing or penetrating member or cannula.

10. An apparatus as defined in claim 1, wherein the at least one piercing or penetrating member or cannula is removable from the dispensing station after the cap is applied thereto, and replaceable with a different piercing or penetrating member or cannula.

11. An apparatus as defined in claim 1, further comprising one or more of (i) a sterile or aseptic connector or (ii) a sterile or aseptic fluid line configured for aseptic or sterile delivery of the substance from one or more of (a) the source of substance to the dispensing station or (b) the device to a patient.

3. An apparatus comprising:

a housing at least partially defining a processing space;

a support for releasably holding at least one device defining an interior sealed from ambient atmosphere, and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula;

a conveyor defining a path for transporting the support and the at least one 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 an exterior portion of the elastic member;

a dispensing station located on the conveyor path downstream of the de-contamination station and including at least one piercing or penetrating member or cannula coupled or connectible in fluid communication with a source of substance to be dispensed into the interior of the device, wherein one or more of (i) the at least one piercing or penetrating member or cannula or (ii) the device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member;

a sealing station located on the conveyor path downstream of the dispensing station configured to hermetically seal the interior from ambient atmosphere; and

a source of substance placeable into and removable from fluid communication with the dispensing station by a sterile or aseptic connector comprising a first connector portion and a second connector portion that are movable between a disconnected position wherein the first and second connector portions are not connected to each other and a connected position wherein the first and second connector portions are connected to each other, and that is configured to provide, in the connected position, a fluid flow path between the source of substance and the dispensing station that is sealed from the ambient atmosphere and the source of substance is placed into fluid communication with the dispensing station, and, in the disconnected position, maintains the fluid flow path sealed from the ambient atmosphere and the source of substance is not in fluid communication with the dispensing station.

4. An apparatus as defined in claim 3, wherein the source of substance comprises a carousel configured to releasably 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 controller disposed between the source of substance and the dispensing station configured to control the fluid flow between the source of substance and the dispensing station.

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

20. An apparatus as defined in claim 3, further comprising:

a formulation container including a formulation chamber that is sealed with respect to ambient atmosphere;

at least one inlet port in fluid communication with the formulation chamber;

at least one outlet port in fluid communication with the formulation chamber;

a plurality of substance supply containers, each containing at least one component of said substance therein;

a plurality of sterile or aseptic connectors sealingly connected in fluid communication with the at least one inlet port, wherein each of the plurality of connectors is normally closed and defines a flow conduit therein that is sterile and sealed with respect to ambient atmosphere for preventing exposure of any substance flowing therein to the ambient atmosphere and is configured to place the at least one inlet port in fluid communication with a respective at least one component from a respective supply container, wherein the plurality of connectors seal the at least one inlet port with respect to ambient atmosphere;

and at least one outlet sterile or aseptic connector sealingly connected in fluid communication with the at least one outlet port, wherein each outlet connector is normally closed and defines a flow conduit therein that is sterile or aseptic and sealed with respect to ambient atmosphere for preventing exposure of any substance flowing therein to the ambient atmosphere, wherein the at least one outlet connector seals the at least one outlet port with respect to ambient atmosphere, and is configured to place the at least one outlet port in aseptic or sterile fluid communication with the dispensing device.

21. An apparatus as defined in claim 20, wherein each of the plurality of connectors and each outlet connector comprises a male connector portion including a piercing or penetrating member or cannula, and a female connector portion including an elastic member, and the male connector and female connector are engageable with each other to define a fluid flow path through the respective connector or outlet connector.

22. An apparatus as defined in claim 20, further comprising a plurality of flexible fluid lines, wherein each flexible fluid line is sealingly connected in fluid communication between the at least one inlet port and one of the connectors or the at least one outlet port and at least one of the at least one outlet connector, and an exterior of each respective flexible fluid line is engageable with a respective peristaltic pump for pumping fluid through the respective fluid line with the respective peristaltic pump.

23. An apparatus as defined in claim 20, further comprising a dispensing device that is sealed from the ambient atmosphere, in fluid communication with at least one of the at least one outlet connector, and configured to receive therefrom multiple doses of a formulation of components from said supply containers while maintaining said doses of formulation sealed with respect to ambient atmosphere.

28. An apparatus as defined in claim 3, wherein

a

the elastic member defines an interior surface in fluid communication with the interior of the at least one device and an exterior surface;

and

during the at least one piercing or penetrating member or cannula penetrating or passing through the elastic member, an annular interface is formed between the elastic member and the at least one piercing or penetrating member or cannula extending axially between a point of contact on the interior surface of and the exterior surface of the elastic member engaging the at least one piercing or penetrating member or cannula, and the piercing or penetrating member or cannula is de-contaminated by one or more of (i) imparting sufficient friction force between the elastic member and the piercing or penetrating member or cannula at the annular interface, or (ii) sufficient elongation of the elastic member at the annular interface.

29. An apparatus as defined in claim 28, wherein the elastic member defines a penetration zone that is penetrable or passable through by the at least one piercing or penetrating member or cannula, and the penetration zone is shaped to enhance pressure exerted by the elastic member onto the at least one piercing or penetrating member or cannula during penetration or passing through thereof by the at least one piercing or penetrating member or cannula.

30. An apparatus as defined in claim 28, further comprising means for reducing strain on the interior surface of the elastic member during penetration or passing through thereof by the at least one piercing or penetrating member or cannula.

31. An apparatus as defined in claim 28, wherein the elastic member is configured to exert pressure onto the at least one piercing or penetrating member or cannula at the annular interface between the elastic member and at least one piercing or penetrating member or cannula to thereby kill organisms at the interface.

32. An apparatus as defined in claim 30, wherein the means for reducing strain includes a groove formed on the interior surface of the elastic member.

8. A method comprising the following steps:

(i) installing at least one piercing or penetrating member or cannula into a dispensing device and in fluid communication with a source of substance, wherein the at least one piercing or penetrating member or cannula is housed within a cap and the dispensing device comprises;

a housing at least partially defining a processing space;

a support for releasably holding at least one device defining an interior sealed from ambient atmosphere, and an elastic member in fluid communication with the interior and penetrable by a piercing or penetrating member or cannula;

a conveyor defining a path for transporting the support and the at least one 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 said elastic member;

a dispensing station located on the conveyor path downstream of the de-contamination station and including the at least one piercing or penetrating member or cannula, wherein one or more of (a) the at least one piercing or penetrating member or cannula or (b) the at least one device is movable relative to the other within the dispensing station to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispense substance through the at least one piercing or penetrating member or cannula and into the interior, and withdraw the at least one piercing or penetrating member or cannula from the elastic member; and

a sealing station located on the conveyor path downstream of the filling station configured to hermetically seal the interior from ambient atmosphere;

(ii) removing the cap from the at least one piercing or penetrating member or cannula;

(iii) storing the cap in the dispensing device at a storage location;

(iv) de-contaminating at least an exterior portion of an elastic member of a device defining an interior sealed from ambient atmosphere in fluid communication with the elastic member;

(v) moving one or more of (a) the at least one piercing or penetrating member or cannula or (b) the device relative to the other to penetrate or pass through the elastic member with the at least one piercing or penetrating member or cannula, dispensing substance through the at least one piercing or penetrating member or cannula and into the interior, and withdrawing the at least one piercing or penetrating member or cannula from the elastic member; and

(vi) sealing the interior from ambient atmosphere.

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

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

(viii) re-attaching the cap to the at least one piercing or penetrating member or cannula.

12. A method as defined in claim 8, further comprising one or more of (i) connecting a source of substance into fluid communication with the at least one piercing or penetrating member or cannula via one or more of a sterile or aseptic connector or sterile or aseptic fluid line;

or (ii) connecting an outlet of the device to a patient delivery device via a one or more of a sterile or aseptic connector or a sterile or aseptic fluid line.

13. A method as defined in claim 8, further comprising:

removing the capped at least one piercing or penetrating member or cannula from the dispensing device; and

replacing the removed at least one piercing or penetrating member or cannula with another capped piercing or penetrating member or cannula.

14. A method as defined in claim 8, further comprising:

aseptically or sterile transferring a plurality of sterile or aseptic components of said substance from respective component supply containers to a formulation container, and combining the plurality of components within the formulation container into a sterile or aseptic formulation defining said substance, wherein each component is sealed with respect to ambient atmosphere in its respective component supply container, the transferring is performed without exposure of the components to the ambient atmosphere, and the components are sealed with respect to ambient atmosphere in the formulation container.

15. A method as defined in claim 14, further comprising aseptically or sterile transferring the formulation from the formulation container to the dispensing device without exposure of the formulation to the ambient atmosphere, wherein the formulation is sealed with respect to ambient atmosphere in the dispensing device.

16. A method as defined in claim 15, further comprising dispensing multiple doses of the formulation through the at least one piercing or penetrating member or cannula while maintaining formulation sterile or aseptic and hermetically sealed with respect to the ambient atmosphere.

17. A method as defined in claim 16, wherein one or more of (i) the transferring of components to the formulation container or (ii) the transferring of formulation to the dispensing device is performed without exposure of the respective components or formulation to germs or other contaminants.

18. A method as defined in claim 15, wherein the transferring of components from the respective component supply containers to the formulation container includes moving one or more of (i) a piercing or penetrating member or cannula or (ii) an elastic member relative to the other between a first position where the piercing or penetrating member or cannula is not penetrating the elastic member and a second position where the piercing or penetrating member or cannula is penetrating or passing through the elastic member, decontaminating the piercing or penetrating member or cannula by one or more of (i) imparting sufficient friction force between the elastic member and piercing or penetrating member or cannula an annular interface between the piercing or penetrating member or cannula, or (ii) sufficient elongation of the elastic member at the annular interface during movement between the first position and the second position, and introducing at least one of the plurality of components through the piercing or penetrating member or cannula in the second position.

19. A method as defined in claim 15, further comprising one or more of (i) connecting a respective sterile or aseptic connector in fluid communication between each respective component supply container and the formulation container, wherein the transferring to the formulation container includes one or more of transferring a respective component through the respective connector, or (ii) connecting an outlet sterile or aseptic connector in fluid communication between the formulation container and the dispensing device, wherein the transferring to the dispensing device includes transferring the formulation from the formulation container through the outlet connector.

24. A method as defined in claim 8, wherein:

the at least one piercing or penetrating member or cannula defines a hollow interior in fluid communication with the source of substance and at least one port in fluid communication with the hollow interior for flowing substance therethrough; and

step (v) includes penetrating or passing through the elastic member with the at least one piercing or penetrating member or cannula so that the at least one port is in fluid communication with the interior of the at least one device, and during the penetrating or passing through step, forming an annular interface between the elastic member and the at least one piercing or penetrating member or cannula extending axially between a point of contact on an interior surface of the elastic member in fluid communication with the interior of the device and an exterior surface of the elastic member engaging the at least one piercing or penetrating member or cannula, and de-contaminating the at least one piercing or penetrating member or cannula by one or more of (i) imparting sufficient friction force between the elastic member and the at least one piercing or penetrating member or cannula at the annular interface, or (ii) sufficient elongation of the elastic member at the annular interface during the penetrating or passing through step.

25. A method as defined in claim 24, wherein the elastic member defines a penetration zone that is penetrated or passed through by the at least one piercing or penetrating member or cannula during the penetrating or passing through step, and the penetration zone is shaped to enhance the pressure exerted by the elastic member onto the at least one piercing or penetrating member or cannula during the penetrating or passing through step.

26. A method as defined in claim 24, further comprising reducing strain on the interior surface of the elastic member within a zone of penetration of the at least one piercing or penetrating member or cannula during the penetrating or passing through step with a groove formed on the interior surface of the elastic member and extending substantially about the zone of penetration.

27. A method as defined in claim 24, wherein the de-contaminating of the at least one piercing or penetrating member or cannula includes exerting pressure with the elastic member onto the at least one piercing or penetrating member or cannula at the annular interface between the elastic member and the at least one piercing or penetrating member or cannula and, in turn, killing organisms at the interface.