Infusion device for medical use

• US 20060058774A1
• Filed: 06/12/2003
• Published: 03/16/2006
• Est. Priority Date: 07/09/2002
• Status: Active Grant

• Current Assignee: Gambro Lundia AB (Baxter International Inc.)
• Original Assignee: Gambro Lundia AB (Baxter International Inc.)
• Inventors: Caleffi, Luca, Delnevo, Annalisa
• Granted Patent: US 7,316,662 B2
• Time in Patent Office: Days
• US Class Current: 604/500
• CPC Class Codes: A61M 5/165 Filtering accessories, e.g. blood filters, filters for infusion liquids A61M1/14 , A61M1/34, A61M1/3627, A61M1/3679, A61M1/3687 take precedence; needle sets with incorporated air inlet filters A61M5/162
• CPC Class Codes: A61M 5/16845 by weight
• CPC Class Codes: A61M 5/16895 by monitoring weight change, e.g. of infusion container
• CPC Class Codes: A61M 5/36 with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281

Abstract

An infusion device for medical use has a container designed to hold a specified quantity of a liquid to be infused into a patient, a weighing device associated for operation with the container to measure the weight of the container and emit a corresponding signal, a transport line connected to the container, a pump, and a control unit associated with the weighing device and with the pump. The control unit is capable of detecting the end of infusion condition and of commanding the pump to stop the transport of fluid. A separator for continuously separating fluid into a gaseous portion and a liquid portion operates in the infusion line downstream of the pump and prevents the infusion of gas during the stopping transient of the pump at the end of infusion.

Claims

1. An infusion device for medical use, comprising:

at least one container designed to hold a specified quantity of a liquid to be infused into a patient;

a weighing device associated for operation with said container to measure the weight of the container and emit a corresponding control signal;

a transport line connected to said container to convey the liquid, in operating conditions, towards an infusion point;

means for moving a flow of the liquid along said line;

a control unit associated with said weighing device and with said movement means, the control unit receiving said control signal and being capable of detecting at least one end of infusion condition;

a continuous fluid separator capable of separating the fluid into a gaseous portion and a liquid portion, said separator operating in said transport line.

2. The device of claim 1, wherein said separator comprises a containing body having:

at least one inlet for receiving a fluid from said container;

at least a first outlet for receiving a liquid portion of said fluid; and

selector means interposed between said inlet and said first outlet and capable of continuously separating said fluid into a gaseous portion and a liquid portion.

3. The device of claim 2, wherein said containing body of the separator comprises at least a second outlet for receiving said gaseous portion of said fluid.

4. The device of claim 2, wherein said selector means comprise at least one hydrophilic membrane having one side facing said first outlet and one side facing said inlet, for receiving said fluid and transferring only liquid towards said first outlet.

5. The device of claim 3, wherein said selector means comprise at least one hydrophobic membrane having one side facing said second outlet and one side facing said inlet, for receiving said fluid and transferring only gas towards said second outlet.

6. The device of claim 1, wherein said separator is interpositioned between said movement means and said infusion point.

7. The device of claim 1, wherein said separator is positioned immediately downstream of said movement means.

8. The device of claim 1, comprising a rigid support holding opposite ends of a first length of tubing of said line designed to interact with said movement means, said first length of tubing having a curved shape and a predetermined axial extension.

9. The device of claim 8, wherein said line comprises a second length of tubing extending between said container and said rigid support and put into fluid communication with said first length.

10. The device of claim 8, wherein said rigid support comprises a first lateral portion forming said containing body.

11. The device of claim 10, wherein said rigid support comprises a second lateral portion with a tubular profile to which are fixed corresponding ends of said first and said second length of tubing of said line, said second lateral portion being distanced from said first portion.

12. The device of claim 3, wherein said containing body comprises a base and a cover portion, interacting with each other to form a passage for fluid between said inlet and said first and second outlets.

13. The device of claim 12, wherein said base forms a through channel for putting said passage into fluid communication with the exterior, a hydrophobic membrane operating in said channel.

14. The device of claim 12, wherein said base comprises an incorporated first tubular connecting element.

15. The device of claim 14, wherein said cover portion comprises an incorporated second tubular connecting element having an axis of extension which is inclined with respect to an axis of extension of said first tubular connecting element.

16. The device of claim 12, wherein said hydrophilic membrane is interpositioned between said base and said cover portion, and extends throughout said containing body.

17. The device of claim 12, wherein each of said base and said cover portion comprises a corresponding base wall and a corresponding perimeter edge emerging from said base wall, a hydrophilic membrane extending parallel to said base wall and distanced there-from.

18. The device of claim 17, wherein said containing body has a plurality of projections emerging from said base wall of said base.

19. The device of claim 17, wherein said containing body has a plurality of projections emerging from said base wall of said cover portion.

20. The device of claim 18, wherein said base projections comprise teeth distributed uniformly over the surface of said base wall of said base.

21. The device of claim 19, wherein said cover portion projections comprise deflectors spaced angularly to guide a flow of liquid towards said first outlet.

22. The device of claim 11, wherein said first and second lateral portions are rigidly connected by a rigid cross-piece.

23. The device of claim 22, wherein said base of said containing body, said rigid cross-piece and said second lateral portion are made in a single piece.

24. The device of claim 22, wherein said rigid cross-piece is essentially flat and parallel to a lie plane of said first length of tubing.

25. The device of claim 1, wherein said control unit is configured to perform an appropriate end of infusion procedure when an end of infusion condition is detected.

26. The device of claim 25, wherein said end of infusion procedure comprises a stage of commanding said movement means to stop transport of said fluid along said line.

27. The device of claim 25, wherein said end of infusion procedure comprises a stage of signalling that the end of infusion condition has been reached.

28. The device of claim 1, comprising a plurality of said containers, said transport line exhibiting a plurality of branches for fluid connection of each container to said infusion point, and a corresponding flow shut-off element acting on each of said branches.

29. The device of claim 28, wherein said control unit is capable of performing an appropriate end of infusion procedure when the end of infusion condition is detected, said end of infusion procedure comprising a stage of commanding an opening of a shut-off element associated with a container which is not empty.

30. The device of claim 1, comprising at least one check valve, predisposed on said transport line to prevent a flow which is inverse to an infusion direction.

31. The device of claim 30, wherein said check valve is arranged between said continuous fluid separator and said infusion point.

32. The device of claim 31, wherein said check valve is arranged immediately downstream of said continuous fluid separator.

33. The device of claim 30, wherein said check valve is an integral part of a rigid support holding opposite ends of a first length of tubing of said line designed to interact with said moving means.

34. The device of claim 30, wherein said check valve is arranged internally of a containing body in a zone comprised between said selector means interposed between an inlet and an outlet of said containing body and said outlet, said selector means being capable of continuously separating said fluid into a gaseous portion and a liquid portion.

35. The device of claim 30, wherein said check valve comprises a mobile obturator organ, which operates on a passage mouth of said liquid portion.

36. The device of claim 35, wherein said passage mouth is associated with a cover portion of said containing body.

37. The device of claim 36, wherein said cover portion comprises a base wall and wherein said selector means comprises at least one hydrophilic membrane facing and distanced from said base wall, said passage mouth being associated to said base wall).

38. The device of claim 5, wherein said containing body internally defines a fluid passage between said separator inlet and said first outlet, said hydrophobic membrane being situated in an upper zone of a fluid passage portion located upstream of said hydrophilic membrane, said hydrophobic membrane facing upwards in a use configuration of said support element.

39. The device of claim 38, wherein said upstream passage portion for fluid passage has at least one passage section which progressively increases in a direction towards said hydrophobic membrane.

40. The device of claim 39, wherein said hydrophobic membrane is located superiorly with respect to an upper point of the operative surface of said hydrophilic membrane.

41. The device of claim 11, wherein said containing body has a development which is prevalently in a transversal direction proceeding from said first lateral portion to said second lateral portion, said first outlet being located in a lateral end zone of said transversal development, in proximity of said second lateral portion.

42. The device of claim 41, wherein said second outlet is arranged in an intermediate zone of said transversal development.

49. An apparatus for extracorporeal blood treatment, comprising a device according to claim 1.

50. An apparatus for extracorporeal blood treatment, comprising a device according to claim 1, an extracorporeal circuit and a blood treatment unit positioned in said circuit, said second connecting element being directly and removably connected to a connector of said extracorporeal blood circuit upstream or downstream of said blood treatment unit.

43. An infusion device for medical use, comprising:

at least one container designed to hold a specified quantity of a fluid to be infused into a patient;

a transport line connected to said container to convey said fluid, in operating conditions, in an infusion direction leading from said container towards an infusion point;

at least one continuous fluid separator, operating on said transport line and separating said fluid into a gaseous portion and a liquid portion;

at least one check valve, operating on said transport line for preventing a flow in an inverse direction to said infusion direction;

a rigid containing body having at least one inlet and at least a first outlet for a fluid, inserted in said transport line, said containing body contains said separator and said check valve, both of which separator and check valve are arranged between said at least one inlet and said at least one outlet.

44. The device of claim 43, wherein said continuous fluid separator further comprises a containing body having:

at least one inlet for receiving fluid from said container;

at least a first outlet for receiving a liquid portion of said fluid; and

selector means interposed between said inlet and said first outlet and capable of continuously separating said fluid into a gaseous portion and a liquid portion.

45. The device of claim 44, wherein said check valve is arranged internally of said containing body in a zone comprised between said selector means and said first outlet.

46. The device of claim 43, wherein said check valve comprises a mobile obturating organ operating on a passage mouth of said liquid portion.

47. The device of claim 44, wherein said passage mouth is associated with said cover portion of said containing body.

48. The device of claim 47, wherein said cover portion comprises a base wall, and wherein said selector means comprise at least one hydrophilic membrane which faces said base wall and is distanced therefrom, said passage mouth being associated to said base wall.