Apparatus and method for preventing free flow in an infusion line

• US 7,815,612 B2
• Filed: 09/14/2005
• Issued: 10/19/2010
• Est. Priority Date: 05/11/2000
• Status: Active Grant

• Current Assignee: Zevex (Moog Incorporated)
• Original Assignee: Zevex (Moog Incorporated)
• Inventors: Allen, Blake, Beck, Kent F., Dickey, John, McNally, David J., Cise, David
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew M
• Application Number:
  US11/226,856
• Publication Number:
  US 20060058740A1
• Time in Patent Office: 1,861 Days
• Field of Search: 604/246, 604/247, 604/256, 417476-47714
• US Class Current: 604/246
• CPC Class Codes: A61M 2039/242 designed to open when a predetermined pressure or flow rate has been reached, e.g. check valve actuated by fluid
• CPC Class Codes: A61M 2039/2473 Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
• CPC Class Codes: A61M 2039/2486 Guided stem, e.g. reciprocating stopper
• CPC Class Codes: A61M 39/22 Valves or arrangement of valves A61M39/02, A61M39/0247, A61M39/16 take precedence; regulating valves in infusion systems A61M5/16881; in devices worn by the patient for the reception of urine, faeces, catamenial or other discharge, or in colostomy devices A61F5/4405
• CPC Class Codes: A61M 39/24 Check- or non-return valves
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/14232 Roller pumps

Abstract

An apparatus and method for preventing free flow through an infusion set utilizes an occluder disposed within the infusion set to selectively prevent flow therethrough. The occluder may be responsive to a pressure differential within the infusion set or may respond to compression of the infusion set. The occluder may also be configured to allow flow when the infusion set adjacent the occluder is moved sideways relative to the occluder or maintained at an angle relative to the occluder. When a pair of occluders are used in sequence, an in-line pump may be formed.

Claims

1. An occluder for use in an infusion set, the occluder comprising:

a body having a proximal section and a proximal end, the proximal section and proximal end of the body being configured for disposition in the lumen of a piece of tubing of an infusion set;

an arm attached to the proximal end of the body, the arm being smaller in diameter than the lumen of the piece of tubing so as to not contact the lumen;

a stop attached to the arm and configured for disposition in the lumen of a piece of tubing of an infusion set, the stop having at least one generally annular rib formed thereon and configured for engaging the tubing to form a seal, and wherein the occluder is configured to selectively allow flow by allowing flow between the at least one generally annular rib and the tubing; and

wherein the proximal endmost portion of the body contacting the lumen of the tubing where the body joins the arm is greater in diameter than the at least one generally annular rib.

2. The occluder of claim 1, wherein the proximal end of the body adjacent the stop is greater in diameter than the generally annular rib by between 0.01 and 0.06 inches.

3. The occluder of claim 1, wherein the at least one generally annular rib has a generally cylindrical outer surface having a bevel formed on each side thereof.

4. The occluder of claim 1, wherein the at least one generally annular rib has a generally cylindrical outer surface having a radius formed on each side thereof.

5. The occluder of claim 1, wherein the proximal portion of the stop is tapered and wherein the proximal end of the stop defines a generally flat surface generally perpendicular to the axis of the occluder.

6. An infusion set comprising the occluder of claim 1, and further comprising a section of tubing into which the body and the stop of the occluder are inserted.

7. The infusion set of claim 6, wherein the axis of the tubing adjacent to the occluder stop is disposed at an angle between about 10 degrees and about 40 degrees relative to the long axis of the occluder.

8. An infusion delivery system comprising the infusion set of claim 7, and further comprising a pump rotor, and wherein the axis of the tubing is disposed at an angle relative to the axis of the occluder by selectively positioning the occluder relative to the rotor.

9. An infusion delivery system comprising the infusion set of claim 7, and further comprising a projection, and wherein the projection presses on the tubing adjacent the occluder stop.

10. The infusion set of claim 7, wherein a flow channel is opened adjacent the stop due to the disposition of the tubing.

11. The infusion set of claim 7, wherein the angle is about 25 degrees.

12. A system comprising the occluder of claim 1, and further comprising an infusion tubing into which the body and stop of the occluder are disposed and an infusion pump, the infusion pump comprising a pumping mechanism and a bracket, wherein the bracket is configured for receiving the occluder and disposed such that the axis of the occluder is disposed at an angle relative to the bore of the tubing when the tubing and occluder are mounted into the pump.

13. The system according to claim 12, wherein the occluder is disposed at about a 25 degree angle relative to the tubing bore.

14. A system comprising the occluder of claim 1, and further comprising an infusion tubing into which the occluder body and stop are disposed, and an infusion pump, the pump having a projection disposed such that the projection presses on the tubing adjacent the stop so as to hold the tubing adjacent the stop at an angle relative to the occluder when the occluder and infusion tubing are mounted in the pump to thereby reduce the pressure necessary for fluid to flow past the occluder.

15. The system of claim 14, wherein the angle is between about 10 and 40 degrees.

16. The system of claim 14, wherein a flow channel is opened adjacent the stop between the stop and the tubing.

17. The system of claim 14, wherein the projection is formed as part of a pump door, and wherein the projection pushes against the tubing when the door is closed.

18. A method for selectively preventing flow in an infusion set comprising:

selecting an occluder, the occluder comprising a body having a proximal end and a distal end and a stop attached to the proximal end of the body by an arm, the arm being smaller in diameter than the body; and

disposing the occluder body and stop inside the bore of an infusion set tubing such that a seal is formed between the stop and the tubing, such that the proximal end of the body engages the tubing, and such that the arm does not engage the tubing; and

wherein the end of the body nearest the occluder at the location where the arm attaches to the body contacts the bore of the tubing and is larger in diameter than the stop.

19. The method of claim 18 wherein the method further comprises selecting an occluder having a pair of generally annular ribs formed on the stop, and wherein the proximal end of the body is larger in diameter than the generally annular ribs.

20. The method of claim 18, wherein the method further comprises disposing a section of tubing adjacent the stop at an angle relative to the occluder sufficient to open a flow channel adjacent the stop.

21. The method of claim 18, wherein the method further comprises displacing a section of tubing adjacent the stop with at least one projection to thereby maintain the section of tubing adjacent the stop at an angle relative to the occluder.

22. The method of claim 21, wherein the method comprises engaging the projection to the tube by movement of a pump door.

23. The method of claim 18, wherein the method further comprises mounting the occluder into an infusion pump and closing a door of the infusion pump having at least one projection formed thereon such that the projection on the door displaces the tubing adjacent the stop.

24. The method of claim 18, wherein the method further comprises disposing the occluder and at least a portion of the infusion set in a pump having a pump rotor and disposing the occluder in the pump such that the occluder and pump rotor are oriented to position a section of tubing between the occluder and pump rotor at an angle relative to the occluder.

25. The method of claim 24, wherein the angle between the section of tubing and the occluder changes as the rotor rotates.

26. The method of claim 24, wherein the method further comprises positioning the section of tubing at an angle of about 25 degrees relative to the occluder.

27. The method of claim 18, wherein the method further comprises selecting an occluder wherein the stop has a rib formed thereon and wherein the proximal end of the body is greater in diameter than the rib.

28. A method for controlling flow in an infusion set comprising:

selecting an infusion set, the infusion set having tubing with a bore therethrough;

selecting an occluder having a body having a proximal end configured for disposition in the bore of the infusion set, the occluder having a stop attached to the proximal end of the body by an arm having a diameter less than an outer diameter than the stop, the stop being sufficiently large in diameter so as to form a seal between the stop and the tubing and thereby prevent flow past the stop;

disposing the proximal end of the body and the stop of the occluder in the infusion set so as to prevent flow through the infusion set, and wherein, at the endmost portion of the body where the body is attached to the arm, the arm does not contact the tubing and the endmost portion of the body connected to the arm contacts the infusion set tube and is larger in diameter than the stop;

disposing the infusion set in an infusion pump such that the pumping mechanism occludes flow through the tubing and such that a flow channel is created adjacent the stop so as to allow flow past the occluder.

29. The method of claim 28, wherein the method comprises positioning the tubing adjacent the occluder at an angle relative to the axis of the occluder so as to open a flow channel between the stop and the tubing.

30. The method of claim 28, wherein the method further comprises applying pressure to the tubing adjacent the stop so as to open a flow channel between the stop and the tubing.

31. The method of claim 28, wherein the method further comprises displacing the tubing adjacent the stop with a projection so as to open a flow channel between the stop and the tubing.

32. The method of claim 31, wherein the projection is part of the pump door.

33. The method of claim 28, wherein the method further comprises mounting the occluder in the pump such that the section of tubing between the pumping mechanism and the occluder is positioned at an angle relative to the axis of the occluder so as to open a flow channel between the stop and the occluder.

34. A method for selectively controlling free flow in a delivery set, the method comprising:

selecting an infusion set having tubing having a bore and having an occluder disposed in the bore of the tubing to prevent flow of solution past the occluder, the occluder having a body with an end and a stop attached to the end of the body, wherein fluid flows through the body and exits the body to flow past the stop, and wherein the end of the body attached to the stop, at the location where the fluid exits the body, contacts the bore of the tubing and is larger in diameter than the stop;

mounting the infusion set into an infusion pump so as to allow flow past the occluder.

35. The method according to claim 34, wherein the method comprises applying pressure to the tubing to open a flow channel past the occluder.

36. The method according to claim 34, wherein the method comprises applying force to the tubing adjacent the occluder.

37. The method according to claim 34, wherein the method further comprises applying force to the infusion set tubing to bend the tubing relative to the occluder.

38. The method according to claim 34, wherein the method comprises positioning the tubing adjacent the occluder at an angle of about 10 to 40 degrees relative to the occluder.

39. The method according to claim 34, wherein the method comprises positioning the tubing adjacent the occluder at an angle of about 25 degrees relative to the occluder.

40. An occluder for use in an infusion set, the occluder comprising:

a body configured for disposition in a lumen of a piece of tubing of an infusion set;

an arm attached to a proximal end of the body, the arm being smaller in diameter than the lumen of the piece of tubing so as to not contact the lumen;

a stop attached to the arm and configured for disposition in the lumen of the piece of tubing of an infusion set, being configured for engaging the tubing to form a seal, and wherein the occluder is configured to selectively allow flow by allowing flow between the stop and the tubing; and

wherein, at the location where the body attaches to the arm, the arm does not contact the tubing and the end of the body contacts the lumen of the tubing and is greater in diameter than the stop.

41. The occluder of claim 40, wherein the stop has an annular rib formed thereon, and wherein said end of the body is greater in diameter than the annular rib.

42. An infusion set comprising the occluder of claim 40, and further comprising a section of tubing into which the body and the stop of the occluder are inserted.

43. The infusion set of claim 42, wherein the axis of the tubing adjacent to the occluder stop is disposed at an angle between about 10 degrees and about 40 degrees relative to the long axis of the occluder.

44. The infusion set of claim 43, wherein a flow channel is opened adjacent the stop due to the disposition of the tubing.