Infusion set adaptor

• US 6,852,094 B2
• Filed: 06/25/2003
• Issued: 02/08/2005
• Est. Priority Date: 04/16/2001
• Status: Expired due to Term

• Current Assignee: Zevex (Moog Incorporated)
• Original Assignee: Zevex (Moog Incorporated)
• Inventors: Beck, Kent F., Miles, Scott D., Malmstrom, James A.
• Primary Examiner(s): Look, Edward K.
• Assistant Examiner(s): Fristoe, Jr., John K.
• Application Number:
  US10/606,262
• Publication Number:
  US 20040097885A1
• Time in Patent Office: 594 Days
• Field of Search: 251/4, 251/5, 251/6, 604/449, 604/65, 604/30, 604/31, 604/34, 604/66, 604/67, 604/118, 604/119, 604/246
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/16868 Downstream occlusion sensors
• CPC Class Codes: A61M 2005/16872 Upstream occlusion sensors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3331 Pressure; Flow
• CPC Class Codes: A61M 39/281 Automatic tube cut-off devices, e.g. squeezing tube on detection of air
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/365 Air detectors A61M5/1684 takes precedence; in extracorporeal blood circuits A61M1/3626
• CPC Class Codes: F04B 43/0072 of tubular flexible members
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing

Abstract

A feeding set adaptor and related system for delivering solutions utilize a feeding set adaptor which engages a pump engaging portion of an infusion set and the feeding set adaptor structure to provide monitoring portions for detecting pressures within the infusion set, a sample cell for determining the presence of air within an infusion set, and an anti-freeflow device for selectively preventing freeflow through the infusion set. The feeding set adaptor is configured for mounting on an infusion pump which moves solution through the infusion set for delivery to a patient.

Claims

1. A feeding system comprising:

an infusion set comprising tubing configured for carrying a fluid, the tubing forming at least an inflow line, an outflow line, and a central pump engaging portion;

a first connector configured for attachment to the inflow line of the infusion set and the central pump engaging portion of the infusion set;

a second connector configured for attachment to the outflow line of the infusion set and the central pump engaging portion of the infusion set;

an anti-freeflow mechanism disposed inside the central pump engaging portion of the tubing; and

an optical pressure sensor disposed in optical communication with the infusion set the optical pressure sensor comprising an optical emitter and an optical detector disposed on opposite sides of a section of the infusion set.

2. A feeding system according to claim 1, wherein the anti-freeflow mechanism is attached to and spaced apart at a predetermined distance from one of the first connector and the second connector.

3. A feeding system according to claim 1, wherein the anti-freeflow mechanism comprises a generally ball-shaped member configured for disposition in the tubing of the infusion set.

4. A feeding system according to claim 3, wherein the ball-shaped member is attached to one of the first connector and the second connector and continually spaced away from the connector to which the ball-shaped member is attached so that a flow channel may be formed around the ball-shaped member and into the connector to which the ball-shaped member is attached.

5. The feeding system according to claim 1 wherein the central pump engaging portion extends between the first connector and the second connector.

6. The feeding system according to claim 5, wherein the anti-freeflow mechanism is disposed in one of the inflow line, pump engaging portion and outflow line.

7. The feeding system according to claim 6, wherein the anti-freeflow mechanism is attached to the second connector and disposed in the central pump engaging portion of the infusion set.

8. The feeding system according to claim 7, wherein the outside diameter of the anti-freeflow mechanism is slightly larger than the inside diameter of the pump engaging portion of the infusion set.

9. The feeding system according to claim 5, wherein the anti-freeflow mechanism is a generally ball-shaped member.

10. The feeding system according to claim 1, wherein the optical pressure sensor is configured to monitor the change in size of the infusion set tubing due to changes in pressure within the tubing.

11. The feeding system according to claim 10, wherein the central pump engaging portion comprises at least one protrusion configured to minimize movement of the central pump engaging portion when the pump engaging portion is worked by a pumping mechanism.

12. The feeding set according to claim 11, wherein the at least one protrusion comprises at least one annular ridge formed on the central pump engaging portion.

13. The feeding set according to claim 1, wherein the optical pressure sensor comprises an optical emitter is disposed on one side of a section of the central pump engaging portion and wherein the optical detector is disposed on the opposite side of the section of the central pump engaging portion such that the central pump engaging portion of tubing partially obstructs the flow of light from the emitter to the detector.

14. The feeding set according to claim 13, wherein the section of the central pump engaging portion adjacent the optical emitter and optical detector is sufficiently elastic to expand somewhat in response to changes in pressure within the tubing and thereby change the amount of light emitted from the emitter which strikes the detector.

15. The feeding set according to claim 1, further comprising an optical bubble detector.

16. The feeding set according to claim 15, wherein the optical bubble detector comprises a triangular conduit formed from a transparent material, an optical emitter disposed adjacent one side of the conduit, and an optical emitter disposed along the opposite side of the conduit such that light emitted from the emitter passes through the conduit and is received by the detector, and such that the presence of an air bubble in the conduit changes the amount of light received by the detector.

17. The feeding set according to claim 16, wherein the triangular conduit further comprises a portion having substantially parallel outer walls such that light passing through the portion of the conduit is not substantially refracted, thus allowing a portion of the light emitted from the emitter to be received by the detector regardless of the presence or absence of a bubble in the conduit.

18. The feeding system according to claim 1, wherein the optical sensor monitors pressure at a point along the central pump engaging portion.

19. A solution delivery system comprising:

a feeding set comprising;

an infusion set comprising tubing configured for carrying a fluid and being attached to a first connector and a second connector, the tubing forming at least an inflow line, an outflow line, and a central pump engaging portion, the central pump engaging portion extending between the first connector and the second connector and wherein the central pump engaging portion comprises at least one monitoring portion for optically monitoring pressure within the infusion set and at least one abutment member configured for minimizing movement of the monitoring portion when the pump engaging portion is worked by a pumping mechanism;

a first connector configured for attachment to the inflow line of an infusion set and the central pump engaging portion of the infusion set;

a second connector configured for attachment to the outflow line of an infusion set and the central pump engaging portion of the infusion set;

an anti-freeflow mechanism disposed in communication with the one of the first connector and the second connector, the anti-freeflow mechanism being disposed inside the tubing; and

a void disposed in the solution delivery system and configured for receiving the feeding set, the void comprising at least one tube engagement member, and wherein the abutment member of the pump engaging portion engages the tube engagement member of the solution delivery system to thereby limit movement of the pump engagement portion.

20. The solution delivery system according to claim 19, wherein the at least one tube engaging member defines a recess, and wherein the abutment member comprises a collar configured for resting in the recess.

21. The solution delivery system according to claim 19, wherein the at least one tube engagement member comprises a first tube engagement member and a second tube engagement member disposed adjacent to each other with the monitoring portion extending therebetween.

22. The solution delivery system according to claim 21, wherein the pump engagement portion has a first abutment member disposed to engage the first tube engaging member and a second abutment member disposed to engage the second tube engaging member, the two abutment members being spaced apart and a distance therebetween constituting the monitoring portion of the pump engaging portion of the infusion set.

23. The solution delivery system according to claim 21, wherein the at least one tube engagement member further comprises a third tube engagement member and a fourth tube engagement member disposed adjacent to each other, and the pump engaging portion of the infusion set forming a second monitoring portion extending between the third tube engagement member and the fourth tube engagment member.

24. The solution delivery system according to claim 19, wherein the at least one tube engaging member and the at least one monitoring portion comprise a first monitoring portion and at least one tube engagement configured for disposition upstream from a pump rotor, and a second monitoring portion and at least one tube engagement member configured for disposition downstream from a pump rotor.

25. A feeding set comprising:

an infusion set comprising tubing for carrying a liquid, the tubing comprising an inflow line, and outflow line, and a central pump engaging portion, and wherein the central pump engaging portion is formed with at least one protrusion configured for inhibiting movement of at least one portion of the central pump engaging portion when the central pump engaging portion is worked by a pump;

at least one connector configured for attaching two lines of the feeding set,

an anti-freeflow mechanism disposed inside of the tubing of the infusion set; and

a sample cell formed as part of the at least one connector and configured for detecting bubbles.

26. The feeding set according to claim 25, wherein the sample cell has a pair of side walls disposed at an angle between about 45 and 100 degrees from one another.

27. The feeding set according to claim 26, wherein the sample cell defines a conduit having at least two sides which are disposed at an angle of about 50 to 60 degrees from one another.

28. The feeding set according to claim 27, wherein the conduit has a cross-section which is an equilateral triangle.

29. The feeding set according to claim 25, wherein the conduit is configured such that a light beam entering an empty sample cell exits substantially parallel to the entering light beam, and a light beam entering a sample cell which is full of a liquid does not exit parallel to the entering beam.

30. The feeding set according to claim 25, wherein the conduit is configured such that a light beam entering a sample cell which is full of a liquid exits in a first direction, a light beam entering an empty sample cell exits in a second direction, and a light beam entering a conduit which is either partially full of a liquid or full of a liquid which contains bubbles therein exits in a third direction.

31. The feeding set according to claim 25, wherein the sample cell has a pair of outer walls which extend towards a point, and a generally linear base extending outwardly from the point and disposed to allow light to flow through the base with minimal refraction.

32. A solution delivery system comprising the feeding set according to claim 25, and further comprising a housing disposed adjacent to the sample cell.

33. The solution delivery system according to claim 32, wherein the housing is spaced apart from the sample cell so as to form an air chamber between the housing and the sample cell.

34. The solution delivery system according to claim 32, wherein the housing has a pair of sidewalls which are disposed at an angle of between about 45 and 100 degrees from one another.

35. The solution delivery system according to claim 34, wherein the housing further comprises a base disposed at an angle of about 50 to 60 degrees from each of the sidewalls.

36. A solution delivery system comprising the feeding set according to claim 25, and further comprising a optical sensor disposed to project light into the sample cell.

37. The solution delivery system according to claim 36, wherein the optical sensor comprises an optical signal emitter and an optical signal detector, and wherein the sample cell is disposed between the optical signal emitter and the optical signal detector.

38. The solution delivery system according to claim 36, wherein the sample cell is configured to direct more light emitted from the optical signal emitter to the optical signal detector when the sample cell is at least partially filled with air.

39. The feeding set adaptor of claim 25, wherein the anti-free flow mechanism is configured for disposition in the pump engaging portion of the infusion set.

40. The feeding set adaptor of claim 25, wherein the sample cell is formed integrally with one of the at least one connector and is generally rigid.

41. A method for preventing freeflow in an infusion set, the method comprising:

selecting a feeding set having a pump engaging portion, the feeding set further comprising a connector, a monitoring portion, at least one protrusion configured to inhibit movement of the monitoring portion and an anti-freeflow mechanism configured to selectively stop fluid flow through the infusion set; and

disposing the anti-freeflow mechanism in the pump engaging portion of the feeding set at a fixed distance from the connector to selectively preclude fluid flow therethrough.

42. The method of claim 41, wherein the method further comprises selecting an anti-freeflow mechanism which is attached to one of the at least one connector.

43. The method of claim 41, wherein the method further comprises selecting an anti-freeflow mechanism which allows flow past the anti-freeflow mechanism when a predetermined pressure is generated by a pump.

44. The method of claim 41, wherein the method further comprises selecting an anti-freeflow mechanism which allows flow past the anti-freeflow mechanism when the tubing in which the mechanism is disposed is expanded radially.

45. The method of claim 41, wherein the method further comprises disposing an optical bubble detector in the feeding set.

46. The method of claim 45, wherein the method further comprises selecting a optical bubble detector with an optical emitter and an optical receiver spaced apart from each other, and wherein the optical bubble detector allows a first amount of light to reach the optical receiver when the detector is not placed between the emitter and the receiver, a second amount of light less than the first amount of light to reach the optical receiver when the detector is placed between the emitter and the receiver but a bubble is present in the detector, and a third amount of light which is less than the second amount of light to reach the optical receiver when the detector is placed between the emitter and the receiver and the detector is filled with a liquid.

47. The method of claim 45, wherein the method further comprises selecting an optical bubble detector which comprises a conduit with a triangular cross section.

48. The method of claim 45, wherein the method further comprises selecting an optical bubble detector which comprises a conduit with a generally triangular cross section having a base portion extending from one edge of the conduit, the base portion having parallel side walls and being configured to transmit a light beam without refracting the light beam.

49. A method for detecting air bubbles passing through an infusion set, the method comprising;

selecting a feeding set formed of tubing and consisting of at least an inflow line, and outflow line, and a pump engaging portion, and having a sample cell formed thereon and having at least one protrusion formed on the pump engaging portion for limiting movement of the pump engaging portion when worked upon by a pump;

passing solution through the sample cell; and

disposing the sample cell in an optical signal such that light is refracted differently when air is present in the sample cell than when solution is present in the sample cell to thereby determine the presence of air.

50. The method according to claim 49, wherein the method comprises emitting the light in a plane and positioning the sample cell so that a sidewall of the sample cell is at an angle less than normal to the plane.

51. The method according to claim 49, wherein the method comprises passing the solution through a sample sell which has a triangular cross-section.

52. The method according to claim 49, wherein the method comprises passing light through a portion of the sample cell having walls which are disposed at an angle of between about 47 and 70 degrees so as to refract said light.

53. The method according to claim 49, wherein the method further comprises passing a quantity of light through the sample so that said quantity of light is not refracted or reflected by the contents of the sample cell.

54. The method of claim 49, wherein the at least one protrusion comprises at least one annular ridge.

55. The method of claim 49, wherein the method further comprises selecting a sample cell which further comprises an optical emitter and an optical detector.

56. The method of claim 55, wherein the method further comprises disposing the sample cell between the optical emitter and the optical detector.

57. The method of claim 55, wherein the method further comprises selecting a sample cell which directs more light towards the optical detector when a bubble is present in the cell.

58. The method of claim 55, wherein the method further comprises selecting a sample cell which directs some light towards the optical detector regardless of the contents of the sample cell.

59. The method of claim 49, wherein the method further comprises disposing an occluder in the feeding set tubing.

60. The method of claim 59, wherein the occluder further comprises a connector.

61. The method of claim 59, wherein the occluder prevents flow in the feeding set tubing until a pump generates a predetermined pressure within the feeding set.

62. A method for forming a feeding set, the method comprising:

selecting an infusion set having an inflow line and an outflow line;

connecting the inflow line to a first connector and the outflow line to a second connector;

disposing at least one protrusion on the tubing of the infusion set, the at least one protrusion being configured for inhibiting movement of at least one portion of the infusion set when the infusion set is worked upon by a pump; and

disposing a flow restricting device inside the infusion set.

63. The method according to claim 62, wherein the method comprises selecting at least one of the first connector and the second connector with a flow restricting device formed integrally therewith, so as to selectively prevent flow in the infusion set when the flow restricting device is disposed therein.

64. The method of claim 62, wherein the method further comprises selecting a flow restriction device which occludes the lumen of the infusion set tubing, thereby requiring expansion of the tubing to allow flow around the flow restriction device.

65. The method of claim 62, wherein the method further comprises disposing an optical pressure sensor in the infusion set.

66. The method of claim 65, wherein the method further comprises disposing a portion of the infusion set tubing between an optical emitter and an optical detector.

67. The method of claim 66, wherein the method further comprises disposing at least one retaining wall adjacent the portion of the infusion set to thereby limit expansion of the portion of the infusion set caused by increased pressure within the infusion set.

68. The method of claim 66, wherein the optical detector receives less light from the optical emitter when the portion of the infusion set tubing expands due to increased pressure within the infusion set.

69. The method of claim 66, wherein the method further comprises selecting an infusion set wherein the portion of the infusion set disposed between the optical emitter and the optical detector has a wall thickness which is thinner that the wall thickness of adjacent sections of the infusion set.

70. The method of claim 62, wherein the at least one protrusion comprises at least one flange disposed on the tubing.

71. The method of claim 62, wherein the method further comprises disposing an optical bubble detector in the infusion set.

72. The method of claim 71, wherein the optical bubble detector comprises a sample cell and an optical emitter and an optical receiver.

73. The method of claim 72, wherein the optical receiver receives a first amount of light from the optical emitter when the sample cell is not disposed between the optical emitter and the optical detector, a second amount of light less than the first amount of light when the sample cell is disposed between the optical emitter and the optical detector and the sample cell is empty or a bubble is present in the sample cell, and a third amount of light less than the second amount of light when then sample cell is disposed between the optical emitter and the optical detector and the sample cell is filled with a liquid.

74. The method of claim 72, wherein the sample cell comprises a triangular cross-section.

75. The method of claim 74, wherein the sample cell further comprises a base portion disposed along an edge of the sample cell and extending outwardly from the sample cell, the base portion having parallel side walls such that a beam of light will pass through the base portion with minimal refraction.

76. A method for forming a feeding set, the method comprising:

selecting an infusion set having an inflow line and an outflow line; and

connecting the inflow line to a first connector and the outflow line to a second connector, wherein at least one of the first connector and the second connector has a sample cell disposed therein for monitoring the presence of air bubbles passing through the infusion line, the sample cell comprising a rigid conduit having two non parallel side walls; and

disposing the sample cell between an optical emitter and an optical detector such that the optical detector receives a first amount of light from the optical emitter when the sample cell is properly disposed between the optical emitter and optical detector, a second amount of light greater than the first amount of light when the sample cell is properly disposed between the emitter and detector and a either a bubble is present in the sample cell or the sample cell is empty, and a third amount of light greater than the second amount of light when the sample cell is not properly disposed between the optical emitter and optical detector.

77. The method of claim 76, wherein the method further comprises disposing an anti-freeflow occluder in the tubing at a fixed distance relative to one of the first and second connectors, the occluder comprising a solid head portion attached to a connector by a stem portion, the stem portion creating a conduit within the tubing for fluid flow, and the head portion contacting the inner wall of the tubing sufficiently to prevent flow past the head portion until sufficient pressure is generated to expand the tubing somewhat.

78. The method of claim 76, wherein the method further comprises a pressure sensing portion of the infusion set configured for placement between an optical emitter and an optical detector such that increases in pressure within the tubing increase the diameter of the tubing sufficient to reduce the amount of light transmitted to the optical detector from the optical emitter.

79. A method for forming a feeding set, the method comprising:

selecting an infusion set having a pump engaging portion, an inflow line and an outflow line; and

connecting the inflow line and one end of the pump engaging portion to a first connector and the outflow line and the other end of the pump engaging portion to a second connector;

disposing an occluder inside the tubing of the infusion set;

disposing a bubble detector in the feeding set, the bubble detector configured for placement between an optical emitter and an optical receiver such that a portion of the light emitted by the emitter reaches the receiver when the bubble detector is placed between the emitter and receiver and filled with a fluid, and where a greater portion of the light emitted by the emitter reaches the receiver when a bubble is present in the bubble detector; and

wherein a portion of the pump engaging portion is configured for placement between an optical emitter and an optical receiver such that increases in fluid pressure within the infusion set cause an increase in the diameter of the portion of the pump engaging portion sufficient to cause a reduction in the amount of light emitted by the emitter which reaches the receiver.

80. An infusion set tube, the tube being configured for insertion into a pump and for being connected to an inflow line and an outflow line by an inflow connector and an outflow connector, the infusion set rube comprising:

a length of resilient tubing; and

a plurality of flanges formed integrally with the tubing, the flanges being spaced so as to form at least one monitoring portion and a pump portion wherein the flanges are configured for insertion into corresponding recesses in a pump housing or pump cartridge to thereby inhibit movement of the at least one monitoring portion, and wherein the pump portion is configured for being worked upon by a pump.