STERILE SAMPLING METHODS AND APPARATUS

• US 20130152707A1
• Filed: 02/13/2013
• Published: 06/20/2013
• Est. Priority Date: 11/19/2003
• Status: Active Grant

• Current Assignee: Noble House Hotels & Resorts Limited
• Original Assignee: Noble House Hotels & Resorts Limited
• Inventors: NORRELL, STEPHANIE M., MOBBS, WILLIAM LEONARD, WILSON, CRAIG DOUGLAS, KASHMIRIAN, AVTAR SINGH
• Granted Patent: US 8,777,921 B2
• Time in Patent Office: Days
• US Class Current: 73/863.86
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150366 Blood collection bags, e.g. connected to the patient by a catheter comprising means for removing a small sample of collected blood from the bag collection bags as such A61J1/05, A61M1/0209
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: A61B 5/1545 comprising means for indicating vein or arterial entry
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61J 1/12 with means for holding samples of contents
• CPC Class Codes: A61M 2039/0202 for taking samples
• CPC Class Codes: A61M 39/146 by cutting and welding
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 39/20 Closure caps or plugs for connectors or open ends of tubes
• CPC Class Codes: G01N 1/10 in the liquid or fluent state burettes, pipettes B01L3/02; sampling of ground water E02D1/06; metering by volume of fluids or fluent solid material G01F11/00, G01F13/00
• CPC Class Codes: Y10T 137/8593 Systems

Abstract

An apparatus and method that allow multiple samples of a liquid in a primary container (here called a ‘pouch’) to be taken with minimal danger of contaminating the liquid in the container during the sampling process are disclosed. In an embodiment, a closed sterile sight chamber is connected with the pouch in a sterile manner to allow fluid to flow into the chamber while at the same time allowing air within the chamber to be displaced through a bacterial filter to atmosphere. The connection between the sight chamber and the pouch is then terminated (severed or closed), isolating the pouch from the sampling apparatus. Only then are samples of liquid withdrawn from the sight chamber, while allowing air to flow into the chamber through the bacterial filter.

Claims

1. A method for providing at least one sample of liquid from a quantity of liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the method comprising:

establishing a sterile fluid connection between the pouch and an inlet tube having proximal and distal ends, the proximal end connected to an inlet of a sterile sight chamber, the chamber comprising;

a vent fitted with a bacterial filter through which air can flow to and from the chamber; and

an outlet;

the inlet tube comprising a tube clamp thereon, wherein the connection is established distal to the tube clamp;

after establishing the connection, opening the tube clamp and allowing a quantity of liquid to flow into the chamber from the pouch while venting displaced air from the chamber through the vent;

closing the tube clamp to prevent fluid flow between the pouch and the chamber;

after closing the tube clamp, terminating the connection between the pouch and the inlet tube; and

after terminating the connection, withdrawing at least one sample of liquid from the chamber into at least one sample phial while allowing air to enter the chamber via the vent to replace the liquid withdrawn.

2. The method of claim 1, wherein the pouch comprises a sealed flexible thermoplastic outlet tube, and the inlet tube comprises a flexible thermoplastic inlet tube, and wherein

said establishing a sterile fluid connection between the pouch and the inlet tube is performed by:

clamping the inlet tube to block flow of liquid therethrough;

sterile-docking the inlet tube with the outlet tube to provide a sterile fluid connection therebetween; and

unclamping the inlet tube to permit flow of liquid from the pouch to the chamber; and

said terminating the connection is effected by clamping the inlet tube to block further flow of liquid into the chamber and then heat-sealing the outlet tube from the pouch.

3. The method of claim 1, wherein the vent has an opening to the environment, the method additionally comprising:

restricting the vent by partially covering the opening to restrict flow of air from the chamber when liquid is flowing into the chamber so as to limit the rate of fluid flow and to thereby facilitate the termination of the connection between the pouch and the chamber when a desired amount of liquid has flowed into the chamber.

4. The method of claim 1, wherein the sight chamber is marked with graduations to indicate the volume of liquid therein, wherein the vent has an opening to the environment, and wherein the method additionally comprises:

restricting the vent by partially covering the opening to restrict flow of air into the chamber when said at least one sample is being withdrawn so as to slow the rate of withdrawal of liquid from the chamber, thereby facilitating termination of said withdrawing step when a predetermined volume of liquid has been withdrawn from the chamber into the sample phial, as indicated by reference to said graduations of the chamber.

5. The method of claim 1, wherein a cup-like sample port having an open end and a tubular peripheral wall is connected to the outlet of the chamber, the sample port has an internal diameter adapted to receive a first sample phial having an external diameter approximating the internal diameter of the sample port, and the method additionally comprises:

inserting a tubular spacer into the sample port, the tubular spacer having an internal diameter adapted to receive a second sample phial having an external diameter substantially smaller that the external diameter of the first sample phial; and

inserting the second sample phial into the spacer and sample port, and withdrawing a sample of liquid from the chamber into the second phial.

10. The method of claim 1, wherein the liquid comprises blood, blood serum or blood platelets.

11. The method of claim 1, wherein:

the sight chamber is tubular and transparent and has an upper end and a lower end;

the inlet is located at the upper end and the outlet is located at the lower end;

the vent is located at the upper end;

the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent;

the method comprises maintaining the sight chamber substantially vertical with the upper end above the lower end, and filling a minor quantity of the liquid to one of the graduations, thereby maintaining an air gap between the liquid in the sight chamber and the inlet during said allowing a quantity of the liquid in the pouch to flow into the chamber; and

maintaining the sight chamber substantially vertical with the upper end above the lower end while withdrawing the at least one sample.

12. The method of claim 1, wherein the chamber is transparent and rigid.

13. The method of claim 1, wherein said at least one sample flows into said at least one sample phial under the action of gravity or a vacuum in said at least one sample phial.

14. The method of claim 1, wherein said at least one sample has the same composition as the liquid in the pouch.

15. The method of claim 1, wherein the inlet tube comprises a frangible, and the method comprises breaking the frangible to allow the quantity of liquid to flow into the chamber from the pouch.

6. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:

an inlet tube having proximal and distal ends, wherein the distal end is closed, and the proximal end is connected to an inlet of a sterile sight chamber, the chamber comprising;

a vent fitted with a bacterial filter through which air can flow to and from the chamber; and

an outlet;

the inlet tube comprising a tube clamp thereon, wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; and

the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection.

7. Apparatus according to claim 6, wherein the inlet tube comprises a flexible thermoplastic inlet tube.

8. Apparatus according to claim 7, additionally comprising:

a cup-like sample port having an open end and a tubular peripheral wall for dispensing liquid in the chamber into at least one sample phial in a substantially sterile manner, wherein the sample port is connected to the outlet of the chamber;

the sample port having an internal diameter adapted to receive a first sample phial having an external diameter approximating the internal diameter of the sample port; and

a tubular spacer having an internal diameter adapted to receive a second sample phial having an external diameter substantially smaller than the external diameter of the first sample phial;

the spacer being adapted to be slidably received within the sample port, and the spacer having a lower end;

a clip for clipping the spacer into the sample port when the spacer is received therein;

opposed tabs on the lower end of the spacer, the tabs adapted to extend radially outwards from the open end of the sample port when the spacer is received therein; and

the tabs are adapted to be gripped between a thumb and finger of a user for insertion of the spacer into the sample port so that neither the thumb nor finger enter the sample port during insertion of the spacer into the sample port.

9. Apparatus according to claim 7, wherein:

the sight chamber is tubular and transparent and has an upper end and a lower end;

the inlet is located at the upper end, and the outlet is located at the lower end;

the sample port is joined to the outlet in a rigid manner so that the sight chamber can be supported substantially upright by a user holding the sample port in one hand while inserting a phial into the open end of the sample port with the other hand.

16. Apparatus according to claim 6, wherein:

the inlet tube includes at least one marking positioned between the distal end and the tube clamp indicative of a preferred area for sterile docking

17. Apparatus according to claim 16, wherein:

the inlet tube includes two spaced apart markings positioned between the distal end and the tube clamp indicative of a preferred area for sterile docking

18. Apparatus according to claim 6, wherein:

the sight chamber is tubular and transparent and has an upper end and a lower end;

the inlet is located at the upper end, and the outlet is located at the lower end;

the vent is located at the upper end;

the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent.

19. Apparatus according to claim 8, comprising:

a port cap mounted for rotation about an axis to the open end of the sample port;

the port cap movable to a closed position to close the open end; and

the port cap comprising a releasable lock adapted to hold it in the closed position, wherein the lock comprises a first radially extending tab on the open end of the sample port and a second radially extending tab on the port cap, the tabs being adapted to engage one another when the port cap is in the closed position.

20. Apparatus according to claim 6, wherein the vent has an opening to the environment, and a hinged cap is mounted adjacent the opening, the cap movable between a closed position in which the cap blocks the opening and an open position in which the opening is unblocked and positions therebetween in which the opening is partially blocked.

21. Apparatus according to claim 9, wherein the chamber is transparent and rigid.

22. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:

an inlet tube having proximal and distal ends, and comprising a frangible, the proximal end connected to an inlet of a sterile sight chamber, the chamber comprising;

a vent fitted with a bacterial filter through which air can flow to and from the chamber; and

an outlet;

the inlet tube comprising a tube clamp thereon, wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp; and

the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection.

23. Apparatus according to claim 22, wherein the chamber is transparent and rigid.

24. Apparatus according to claim 22, wherein the inlet tube comprises a flexible thermoplastic inlet tube.

25. Apparatus according to claim 22, wherein the frangible is between the proximal and distal ends of the inlet tube.

26. Apparatus according to claim 22, wherein:

the chamber is tubular and transparent and has an upper end and a lower end;

the inlet is located at the upper end, and the outlet is located at the lower end;

a sample port is joined to the outlet in a rigid manner so that the sight chamber can be supported substantially upright by a user holding the sample port in one hand while inserting a phial into the open end of the sample port with the other hand.

27. Apparatus according to claim 22, wherein:

the sight chamber is tubular and transparent and has an upper end and a lower end;

the inlet is located at the upper end, and the outlet is located at the lower end;

the vent is located at the upper end;

the sight chamber is marked with graduations to indicate the volume of liquid therein, the uppermost of the graduations being below the inlet and vent.

28. Apparatus according to claim 22, wherein the inlet tube is attached to a platelet pouch of an aphaeresis kit.

29. Apparatus for providing at least one sample of a liquid contained in a pouch while mitigating the danger of contaminating the liquid in the pouch, the apparatus comprising:

an inlet tube having proximal and distal ends, and comprising a frangible, the proximal end connected to an inlet of a sterile sight chamber that is transparent, the chamber comprising;

a vent fitted with a bacterial filter through which air can flow to and from the chamber; and

an outlet;

the inlet tube comprising a tube clamp thereon, wherein the tube clamp is a sufficient distance from the distal end to permit a sterile fluid connection to be established with the inlet tube at a point distal to the tube clamp;

the tube clamp operable to regulate liquid flow through the inlet tube to the chamber when the connection is established and operable to block fluid flow in the absence of the connection; and

a cup-like sample port having an open end and a tubular peripheral wall connected to the outlet of the chamber in a rigid manner, wherein the open end is opposite the outlet.

30. Apparatus according to claim 29, wherein the inlet tube is attached to a platelet pouch of an aphaeresis kit.