Method for providing a circuit for biological liquid and circuit obtained

• US 10,195,605 B2
• Filed: 05/23/2016
• Issued: 02/05/2019
• Est. Priority Date: 01/23/2009
• Status: Active Grant

• Current Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Original Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Inventors: Reinbigler, Rene, Weissenbach, Jean-Louis
• Primary Examiner(s): Khare, Atul P.
• Application Number:
  US15/161,768
• Publication Number:
  US 20160264923A1
• Time in Patent Office: 988 Days
• Field of Search: 264500, 264512, 264513, 264516, 264523, 264524, 264529, 264537, 264572, 264573, 264325, 264488, 264525, 264545
• CPC Class Codes: A61L 2/0035 Gamma radiation
• CPC Class Codes: B01L 2200/0689 Sealing
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0487 fluid pressure, pneumatics
• CPC Class Codes: B01L 2400/0655 pinch valves
• CPC Class Codes: B01L 3/502707 characterised by the manufacture of the container or its components by shaping or joining plastic parts B29C59/00, B29C65/00; by laminating B32B37/00; manufacture of microstructural devices in general B81C
• CPC Class Codes: B29C 2049/4805 by closing the mould halves
• CPC Class Codes: B29C 2049/4807 by movable mould parts in the mould halves
• CPC Class Codes: B29C 2949/08 Preforms made of several individual parts, e.g. by welding or gluing parts together
• CPC Class Codes: B29C 33/02 with incorporated heating or cooling means
• CPC Class Codes: B29C 49/0691 using sheet like material, e.g. sheet blow-moulding from joined sheets
• CPC Class Codes: B29C 49/06914 using parallel sheets as a preform
• CPC Class Codes: B29C 49/06916 Means for avoiding parts of the sheets to stick together, e.g. to provide blow opening
• CPC Class Codes: B29C 49/4815 by means of movable mould parts
• CPC Class Codes: B29C 65/02 by heating, with or without pressure
• CPC Class Codes: B29K 2023/0616 VLDPE, i.e. very low density polyethylene
• CPC Class Codes: B29K 2023/083 EVA, i.e. ethylene vinyl acetate copolymer
• CPC Class Codes: B29K 2023/086 : EVOH, i.e. ethylene vinyl alcohol copolymer
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2031/7148 : Blood bags, medical bags
• CPC Class Codes: C12M 23/14 : Bags
• CPC Class Codes: C12M 23/26 : flexible flexible containers for laboratory use B01L3/505
• CPC Class Codes: C12M 23/28 : disposable or single use
• CPC Class Codes: C12M 29/04 : Filters; Permeable or porous membranes or plates, e.g. dialysis
• CPC Class Codes: C12M 47/10 : Separation or concentration of fermentation products bioreactors combined with means for distillation or extraction of liquid fuel C12M43/02
• CPC Class Codes: Y10T 137/8593 : Systems
• CPC Class Codes: Y10T 137/9029 : With coupling

Abstract

The method comprises the step of forming pipes (12) by clamping a bag between shells (13, 14) and by injecting an inflating agent via an inflating connector.

The circuit comprises a bag (126) and a press (10) comprising two shells (13, 14) clamping said bag in a state in which pipes (12) are formed between the films (25, 26) of the bag.

Claims

1. A method comprising:

forming a circuit for routing biological liquid, the circuit comprising a press, a disposable bag, routing network connectors, and a routing network of pipes through which said routing of the liquid is conducted between said connectors, said forming being conducted by;

providing the disposable bag as two flexible films attached together by a seal delimiting a closed contour defined by the two films with each of said routing network connectors and an inflating connector opening respectively inside and outside of said closed contour;

providing the press as two shells, at least one of said shells comprising recessed channels; and

forming said pipes of said routing network between said films by clamping said bag between said shells and injecting a pneumatic inflating agent into said bag between said shells via said inflating connector, said bag and said press being configured such that at least one of said pipes has a contour of which at least one portion is delimited exclusively by cooperation with said press upon said inflating, the portion of the contour of each of the at least one pipe which is delimited exclusively by cooperation with the press comprising opposed contact zones between the films, said contact zones bordering each of said at least one pipe and being fluid-tight, and said injecting causing said pipes to each be formed into conformity with a respective one of said recessed channels so as to define said pipe contour,

wherein said bag remains clamped between said shells during use of the circuit for said routing of the biological liquid, and wherein said pipes of the routing network are not pre-formed in the bags prior to said forming such that said pipes are exclusively delimited within said bag by cooperation of said bag with said press during said use.

2. A method according to claim 1, wherein said inflating connector is separate from said routing network connectors.

3. A method according to claim 1, wherein the step of forming said pipes further comprises beginning the step of injecting said inflating agent before said clamping of said bag between said shells.

4. A method according to claim 3, wherein the step of injecting said inflating agent is preceded by pre-closing said press while said bag is in immediate proximity to each of the two shells.

5. A method according to claim 2, wherein the step of forming said pipes further comprises beginning the step of injecting said inflating agent before said clamping of said bag between said shells.

6. A method according to claim 5, wherein the step of injecting said inflating agent is preceded by pre-closing said press while said bag is in immediate proximity to each of the two shells.

7. A method according to claim 1, wherein said one or more recessed channels of each of said shells has a semi-circular cross-section.

8. A method according to claim 1, wherein the press comprises actuators of pinch valves, and sensors of a physico-chemical value.

9. A method according to claim 8, wherein the actuators each comprise a body attached to one of said shells and a moveable finger capable of adopting a retracted position and a working position projecting from a respective one of said recessed channels of said shell to which the actuator body is attached.

10. A method according to claim 9, wherein each of the actuators enables one of said pipes to be pinched between said moveable finger and the shell to which the actuator is not attached so as to allow or prevent the passage of said liquid at that location.

11. A method according to claim 8, wherein the sensors each comprise a body attached to one of said shells in register with said recessed channels thereof, a distal end of the body opening into each of the recessed channels.

12. A method according to claim 11, wherein the physico-chemical value is a temperature or pressure which can be measured by contact of the distal end with a respective one of said pipes within a respective one of said recessed channels without the sensors contacting said fluid running through the respective pipe.

13. A method according to claim 1, wherein said shells are each formed from stainless steel and are each of a generally parallelepiped shape.

14. A method according to claim 1, wherein the seal delimiting the closed contour is formed at a periphery of the films.

15. A method according to claim 1, further comprising providing obturating plugs on each of the routing network connectors and on the inflating connector and sterilizing the bag by gamma irradiation.

16. A method according to claim 1, wherein said pneumatic inflating agent is compressed air purified through a hydrophobic filter.

17. A method according to claim 1, wherein said recessed channels are bordered on each side thereof at said contact zones by a groove in which is accommodated a respective bead of a network of beads serving to apply said flexible films against each other along said pipes.

18. A method according to claim 1, further comprising a filter enclosed within said disposable bag.

19. A method according to claim 1, further comprising using said circuit to route said biological liquid.

20. A method according to claim 1, wherein each of the two shells comprise said recessed channels, each of the recessed channels of the two shells being substantially semi-circular in cross-section, and each of the recessed channels of one of the two shells cooperating with a respective one of the recessed channels of the other of the two shells so as to define said contour for each of said pipes of which at least one portion of said pipes is delimited exclusively by cooperating with respective recessed channels of the two shells.

21. A method comprising:

forming a circuit for routing biological liquid, the circuit comprising a press, a disposable bag, routing network connectors, and a routing network of pipes through which said routing of the liquid is conducted between said connectors, said forming being conducted by;

providing the disposable bag as two flexible films attached together by a seal delimiting a closed contour defined by the two films with each of said routing network connectors and an inflating connector opening respectively inside and outside of said closed contour;

providing the press as two shells, at least one of said shells comprising recessed channels; and

forming said pipes of said routing network between said films by clamping said bag between said shells and injecting a pneumatic inflating agent into said bag between said shells via said inflating connector, said bag and said press being configured such that at least one of said pipes has a contour of which at least one portion is delimited exclusively by cooperation with said press upon said inflating, the portion of the contour of each of the at least one pipe which is delimited exclusively by cooperation with the press comprising opposed contact zones between the films, said contact zones bordering each of said at least one pipe and being fluid-tight, and said injecting causing said pipes to each be formed into conformity with a respective one of said recessed channels so as to define said pipe contour,

wherein said bag remains clamped between said shells during use of the circuit for said routing of the biological liquid, and wherein said recessed channels are bordered on each side thereof at said contact zones by a groove in which is accommodated a respective bead of a network of beads serving to apply said flexible films against each other along said pipes.

22. A method according to claim 21, wherein said inflating connector is separate from said routing network connectors.

23. A method according to claim 21, wherein the step of forming said pipes further comprises beginning the step of injecting said inflating agent before said clamping of said bag between said shells.

24. A method according to claim 23, wherein the step of injecting said inflating agent is preceded by pre-closing said press while said bag is in immediate proximity to each of the two shells.

25. A method according to claim 22, wherein the step of forming said pipes further comprises beginning the step of injecting said inflating agent before said clamping of said bag between said shells.

26. A method according to claim 25, wherein the step of injecting said inflating agent is preceded by pre-closing said press while said bag is in immediate proximity to each of the two shells.

27. A method according to claim 21, wherein said one or more recessed channels of each of said shells has a semi-circular cross-section.

28. A method according to claim 21, wherein the press comprises actuators of pinch valves, and sensors of a physico-chemical value.

29. A method according to claim 28, wherein the actuators each comprise a body attached to one of said shells and a moveable finger capable of adopting a retracted position and a working position projecting from a respective one of said recessed channels of said shell to which the actuator body is attached.

30. A method according to claim 29, wherein each of the actuators enables one of said pipes to be pinched between said moveable finger and the shell to which the actuator is not attached so as to allow or prevent the passage of said liquid at that location.

31. A method according to claim 28, wherein the sensors each comprise a body attached to one of said shells in register with said recessed channels thereof, a distal end of the body opening into each of the recessed channels.

32. A method according to claim 31, wherein the physico-chemical value is a temperature or pressure which can be measured by contact of the distal end with a respective one of said pipes within a respective one of said recessed channels without the sensors contacting said fluid running through the respective pipe.

33. A method according to claim 21, wherein said shells are each formed from stainless steel and are each of a generally parallelepiped shape.

34. A method according to claim 21, wherein the seal delimiting the closed contour is formed at a periphery of the films.

35. A method according to claim 21, further comprising providing obturating plugs on each of the routing network connectors and on the inflating connector and sterilizing the bag by gamma irradiation.

36. A method according to claim 21, wherein said pneumatic inflating agent is compressed air purified through a hydrophobic filter.

37. A method according to claim 21, wherein said pipes of the routing network are not pre-formed in the bags prior to said forming.

38. A method according to claim 21, further comprising a filter enclosed within said disposable bag.

39. A method according to claim 21, further comprising using said circuit to route said biological liquid.

40. A method according to claim 21, wherein each of the two shells comprise said recessed channels, each of the recessed channels of the two shells being substantially semi-circular in cross-section, and each of the recessed channels of one of the two shells cooperating with a respective one of the recessed channels of the other of the two shells so as to define said contour for each of said pipes of which at least one portion of said pipes is delimited exclusively by cooperating with respective recessed channels of the two shells.