Sterile sensor insertion

Patent metadata

Field	Value
Publication number	US-11499126-B2
Application number	US-201515500623-A
Country	US
Kind code	B2
Filing date	Jul 30, 2015
Priority date	Aug 8, 2014
Publication date	Nov 15, 2022
Grant date	Nov 15, 2022

Abstract

The present invention provides a system for the insertion of a pre-sterilized sensor probe into a sterile vessel. The system of the invention provides a reliable and straightforward way to insert one or more sterile probes into a sterile vessel. The present invention also provides a sterile vessel that includes one or more of the systems of the invention. The sterile vessel can be a flexible or semi-rigid bag or tubing of the type typically used for carrying out biochemical and/or biological processes and/or manipulating liquids and other products of such processes. Furthermore, the present invention provides a method for aseptically inserting a probe into a sterile vessel where the method makes use of the system of the invention.

First claim

The invention claimed is:

1. A system for insertion of a sterile probe into a sterile vessel, the system comprising:
a body formed of plastic and comprising a sterile bore formed through at least a portion of an interior of the body, the body further comprising a first end and a second end, the second end comprising a body sterile face connection, wherein the body further comprises a sterilization port therethrough accessing the sterile bore;
a plunger formed of plastic and contained within the sterile bore of the body, the plunger having a shape substantially corresponding to a shape of the sterile bore and being of a diameter less than a diameter of the sterile bore, the plunger also having an inner channel opening onto a first aperture on a first end of the plunger and a second aperture on a second end of the plunger, wherein the first end and the second end of the plunger correspond respectively to the first end and the second end of the body, and wherein the plunger is moveable relative to the body between a first position and a second position;
a sterile probe positioned within the inner channel of the plunger, wherein the sterile probe comprises an electrical connection end, a sensor end, and a sensor body between the electrical connection end and the sensor end, and wherein the sterile probe is movable relative to the body between a retracted position within the body and an extended position with at least the sensor end outside the body by movement of the plunger between the first position and the second position;
one or more first seals positioned between the plunger and the sterile bore and configured to form a liquid-tight seal between respective portions of the plunger and the sterile bore; and
a handle configured to cooperate with the plunger to direct movement of the plunger within the sterile bore between the first position and the second position.

2. The system as defined in claim 1 , wherein the sterile probe is selected from the group consisting of metabolic sensors, biologic sensors, and physical sensors.

3. The system as defined in claim 2 , wherein the sterile probe is a glucose sensor, a lactate sensor, a pH sensor, a temperature sensor, a conductivity sensor, or a cell mass and cell viability sensor.

4. The system as defined in claim 1 , wherein each of the body and the plunger is independently formed of a plastic selected from the group consisting of polyetherimides (PEI), polyetheretherketone (PEEK), polyetherketone (PEK), polysulphones, polyarylsulphones, polyalkoxysulphones, polyethersulphones, polyphenyleneoxide, polyphenylenesulphide, polycarbonate, and blends thereof.

5. The system as defined in claim 1 , further comprising a sterilization gas in the sterile bore and sterilization port.

6. The system as defined in claim 1 , further comprising one or more second seals positioned between the sterile probe and the inner channel of the plunger.

7. The system as defined in claim 1 , wherein the handle is configured to rotate around a longitudinal axis of the system to direct movement of the plunger within the sterile bore between the first position and the second position.

8. The system as defined in claim 1 , wherein, between the first end of the plunger and the one or more first seals, the plunger comprises a plunger thread on an outer surface of the plunger, wherein the handle comprises a central opening configured to accommodate the plunger, and wherein the central opening comprises a handle thread that cooperates with the plunger thread such that rotational movement of the handle directs the movement of the plunger within the sterile bore between the first position and the second position.

9. The system as defined in claim 8 , wherein the central opening further comprises a recess, wherein the body further comprises a first notch protruding outwardly from a surface of the body and located substantially at first end of the body, and wherein the first notch is received in the recess.

10. The system as defined in claim 9 , wherein the body further comprises a second notch protruding outwardly from the surface of the body, and wherein the second notch provides mechanical support to the interaction of the first notch and the recess.

11. The system as defined in claim 10 , further comprising a cam formed on an outer surface of the plunger and contained within a cam slot defined by the body, wherein the cam is moveable between a first position within the cam slot and a second position within the cam slot, wherein the first position of the plunger is concurrent with the first position of the cam in the cam slot, and wherein the second position of the plunger is concurrent with the second position of the cam in the cam slot.

12. The system as defined in claim 11 , wherein the plunger is locked into the second position.

13. The system as defined in claim 1 , wherein the sensor end of the sterile probe comprises a sheath.

14. The system as defined in claim 1 , wherein the sterile vessel is a biocontainer or a bioreactor.

15. A sterile vessel comprising one or more of the system as defined in claim 13 .

16. The sterile vessel as defined in claim 15 , wherein the sterile vessel is a biocontainer.

17. The sterile vessel as defined in claim 16 , wherein the sterile vessel is a bioreactor.

18. The sterile vessel as defined in claim 17 , wherein the sterile vessel is a flexible bag supported within a rigid holder.

19. The sterile vessel as defined in claim 18 , wherein the sterile vessel comprises a wall including a vessel sterile face connection, and wherein the body sterile face connection is mated with the vessel sterile face connection.

20. The sterile vessel as defined in claim 19 , wherein the body sterile face connection and the vessel sterile face connection are each a single-use aseptic connection.

21. A method for the insertion of a sterile probe into a sterile vessel, wherein the sterile probe is provided as a part of the system as defined in claim 13 , and wherein the sterile vessel comprises a vessel sterile face connection, the method comprising:
mating the body sterile face connection with the vessel sterile face connection; and
actuating the handle so as to move the plunger from the first position to the second position.

22. The method as defined in claim 21 , wherein actuating the handle comprises rotating the handle around a longitudinal axis of the system.

Assignees

• Global Life Sciences Solutions Usa Llc

Inventors

• Pizzi Vincent Francis
• Carter Jeffrey
• Stankowski Ralph

Classifications

• C12M37/00

  Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination (C12M23/38 takes precedence; filtration in general and filters per se B01D24/00-B01D41/00; autoclaves B01J3/04; treatment of microorganisms with electrical or wave energy C12N13/00) · CPC title

• C12M23/28

  disposable or single use · CPC title

• C12M23/00

  Constructional details, e.g. recesses, hinges (flow directing inserts in C12M27/18-C12M27/24; apparatus for chemical or physical processes in general B01J, chemical or physical laboratory apparatus in general B01L) · CPC title

• C12M23/48

  Holding appliances; Racks; Supports (holding devices for laboratory apparatus B01L9/00) · CPC title

• C12M41/00

  Means for regulation, monitoring, measurement or control, e.g. flow regulation (controlling or regulating chemical, physical or physicochemical processes B01J19/0006; heating or cooling apparatus for laboratory use B01L7/00; electro optical investigation of individual particles, flow cytometers G01N15/14; automatic analysis G01N35/00; controlling or regulating in general G06N) · CPC title