Apparatus and method for making a sterile connection of flexible tubing

Patent metadata

Field	Value
Publication number	US-10195416-B2
Application number	US-201414892649-A
Country	US
Kind code	B2
Filing date	May 19, 2014
Priority date	May 20, 2013
Publication date	Feb 5, 2019
Grant date	Feb 5, 2019

Abstract

An apparatus for substantially sterile connection of flexible tubing, including at least one tubing holder, which is adapted to receive one or more lengths of flexible tubing and which is also equipped with one or more sterilant applicators. The sterilant applicator is adapted to apply a sterilant to the length of tubing when the tubing length is received in the tubing holder. At least one cutter, which is movable in relation to the tubing holder and adapted to cut the length of tubing. A connector holder, which includes a compartment housing and a substantially sterile tubing connector. The connector holder is movable in relation to the tubing holder to a position where the length of tubing and the sterile tubing connector are aligned and can be urged together.

First claim

The invention claimed is:

1. An apparatus for substantially sterile connection of flexible tubing in a non-heating process, comprising:
at least one tubing holder, adapted to receive one or more lengths of said tubing and equipped with one or more sterilant applicators adapted to apply a sterilant to the one or more lengths of tubing upon reception of the one or more lengths of tubing in the at least one tubing holder;
at least one cutter, movable in a direction transverse to the one or more lengths of the tubing received in the at least one tubing holder and configured to cut the one or more lengths of tubing upon moving; and
a connector holder comprising:
the at least one cutter at an edge thereof and adjacent to the at least one tubing holder, and
a compartment housing a substantially sterile tubing connector, said connector holder being movable in relation to the tubing holder wherein the connector holder is moved to a position where the at least one cutter cuts the one or more lengths of tubing and the one or more lengths of tubing cut become aligned with the sterile tubing connector and urged together with the sterile tubing connector.

2. The apparatus of claim 1 , further comprising a sterilant reservoir, adapted to supply the sterilant to the one or more sterilant applicators.

3. The apparatus of claim 2 , wherein the sterilant reservoir comprises a breakable ampoule containing the sterilant.

4. The apparatus of claim 3 , wherein the sterilant in the breakable ampoule is an aqueous solution comprising hydrogen peroxide.

5. The apparatus of claim 4 , wherein the solution comprises 3 to 60 wt % hydrogen peroxide.

6. The apparatus of claim 5 , wherein the solution comprises 25 to 35 wt % hydrogen peroxide.

7. The apparatus according to claim 1 , further comprising a movable cover, which in a closed position delimits a cutting and connecting compartment and in an open position allows removal of the cut and connected one or more lengths of tubing.

8. The apparatus according to claim 1 , wherein the tubing connector is a hose barb connector.

9. The apparatus according to claim 1 , wherein the tubing connector comprises a port covered with a removable protective film or cap.

10. The apparatus of claim 1 , wherein each of the at least one tubing holder is adapted to receive a respective one of the one or more lengths of tubing at a point distant from the ends of said one of the one or more lengths of tubing.

11. The apparatus according to claim 1 , wherein the tubing connector is prepared from a deformable plastic and a central part of said tubing connector is concentrically contained in a notched metal tube adapted to upon external compression cut off the tubing connector and fluidically seal off ends of the tubing connector that are cut.

12. The apparatus according to claim 1 , wherein one or more of the at least one cutter comprises a blade or a sharp edge of the connector holder.

13. The apparatus according to claim 1 , which has been sterilized, using ionizing radiation.

14. The apparatus according to claim 1 , wherein the at least one cutter and connector holder are rotationally or linearly movable in relation to the at least one tubing holder.

15. A method for a substantially sterile connection of flexible tubing in a non-heating process, comprising the steps of:
providing the apparatus of claim 1 and at least one length of flexible tubing;
placing the at least one length of tubing in the at least one tubing holder and applying sterilant to the at least one length of tubing with the one or more sterilant applicators;
moving the at least one cutter to cut the at least one length of tubing;
moving the connector holder to the position where the connector is aligned with the at least length of tubing that is cut;
urging the connector and the at least one length of tubing that is cut together to form a connected assembly; and
removing the connected assembly from the apparatus.

16. The method of claim 15 , further comprising, before placing the at least one length of tubing in the at least one tubing holder and applying the sterilant to the at least one length of tubing with the one or more sterilant applicators, a step of fluidically connecting the sterilant in the sterilant reservoir with the one or more sterilant applicators.

17. The method of claim 16 , further comprising a step of breaking an ampoule containing the sterilant.

18. The method of claim 15 , wherein the at least one cutter and the connector holder are rotationally or linearly moved.

Assignees

• Ge Healthcare Bio Sciences Ab

Inventors

• Gebauer Klaus
• Faldt Eric
• Karmarkar Nachiket

Classifications

• A61M2207/00

  Methods of manufacture, assembly or production · CPC title

• A61M39/18 Primary

  Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking · CPC title

• F16L2201/44

  sterile · CPC title

• F16L33/30

  comprising parts inside the hoses only (F16L33/24 takes precedence) · CPC title