HEMODIALYSIS SYSTEM

• US 20140112828A1
• Filed: 05/24/2012
• Published: 04/24/2014
• Est. Priority Date: 05/24/2011
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Grant, Kevin L., Wilt, Michael J., Tracey, Brian D., Rudolf, Brett A., Collins, David E., Panneton, Lisa A., Dale, James D., Bodwell, Jesse T.
• Granted Patent: US 9,724,458 B2
• Time in Patent Office: Days
• US Class Current: 422/44
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3643 Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 Mode of operation
• CPC Class Codes: A61M 1/3647 with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3652 : using gas, e.g. air
• CPC Class Codes: A61M 1/3653 : Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 : Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/367 : Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/121 : interface between cassette and base
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: Y10T 137/87169 : Supply and exhaust

Abstract

A drain cassette for a dialysis unit has a fluid channel between venous and arterial connection ports, and a valve may controllably open and close fluid communication between a drain outlet port and the venous connection port or the arterial connection port. A blood circuit assembly and drain cassette may be removable from the dialysis unit, e.g., by hand and without the use of tools. A blood circuit assembly may include a single, unitary member that defines portions of a pair of blood pumps, control valves, channels to accurately position flexible tubing for an occluder, an air trap support, and/or other portions of the assembly. A blood circuit assembly engagement device may assist with retaining a blood circuit assembly on the dialysis unit, and/or with removal of the assembly. An actuator may operate a retainer element and an ejector element that interact with the assembly.

Claims

1. A drain cassette for a dialysis unit, comprising:

a venous connection port for connection to, and fluid communication with, a venous blood line connector;

an arterial connection port for connection to, and fluid communication with, an arterial blood line connector;

a fluid channel fluidly connecting the venous connection port and the arterial connection port;

a drain outlet port in fluid communication with the fluid channel and arranged to removably couple with a drain connector on an exposed panel of the dialysis unit; and

a valve arranged to control flow in the fluid channel,

wherein the valve is arranged to control in the fluid channel to either controllably open and close fluid communication in the fluid channel between the drain outlet port and the venous connection port or to controllably open and close fluid communication in the fluid channel between the drain outlet port and the arterial connection port.

2. The drain cassette of claim 1, further comprising:

a body that defines the arterial and venous connection ports and the fluid channel.

3. The drain cassette of claim 1, further comprising:

a check valve arranged to allow flow from the fluid channel and out of the drain outlet port and to resist flow from the drain outlet port to the fluid channel.

4. The drain cassette of claim 1, wherein the valve is a pneumatically-controlled valve, the cassette further comprising:

a pneumatic control port arranged to removably mate with a port on the exposed panel, the pneumatic control port being fluidly coupled to the valve to allow control of the valve by the dialysis unit.

5. The drain cassette of claim 1, further comprising:

a latch arranged to releasably lock the drain cassette to the exposed panel.

6. The drain cassette of claim 1, wherein the drain outlet port fluidly communicates with the fluid channel at a point above where the arterial and venous connection ports communicate with the fluid channel.

7. The drain cassette of claim 1, wherein the fluid channel has a U shape.

8. The drain cassette of claim 1, wherein the arterial and venous connection ports are fluidly connected to the fluid channel at ends of the U shape, and the drain outlet port is fluidly connected to the fluid channel at a central bend of the U shape.

9. The drain cassette of claim 1, further comprising:

a conductivity sensor arranged to detect a conductivity of fluid in the fluid channel.

10. The drain cassette of claim 1, further comprising:

a temperature sensor arranged to detect a temperature of fluid in the fluid channel.

11. The drain cassette of claim 1, further comprising:

an electrical connector arranged to mate with a corresponding electrical connector on the exposed panel when the drain outlet port is coupled with the drain connector.

12. The drain cassette of claim 11, further comprising:

one or more sensors arranged to detect a characteristic of fluid in the fluid channel, the one or more sensor being connected to the electrical connector.

13. The drain cassette of claim 1, further comprising:

one or more sensors arranged to detect a characteristic of fluid in the fluid channel; and

an electrical connector arranged to electrically connect the one or more sensors to a corresponding electrical connector on the exposed panel,

wherein the electrical connector and the drain outlet port are arranged to simultaneously couple with a corresponding electrical connector and drain connector on the exposed panel of the dialysis unit in a single connection operation.

14. The drain cassette of claim 13, wherein the valve is a pneumatically-controlled valve, the cassette further comprising:

a pneumatic control port arranged to removably mate with a control port on the exposed panel, wherein the pneumatic control port is arranged to simultaneously couple with the corresponding control port in the single connection operation.

15. The drain cassette of claim 1, wherein the drain outlet port is in permanently open fluid communication with the arterial connection port, and the valve is arranged to controllably open and close fluid communication in the fluid channel between the drain outlet port and the venous connection port.

16. The drain cassette of claim 1, wherein the drain outlet port is in permanently open fluid communication with the venous connection port, and the valve is arranged to controllably open and close fluid communication in the fluid channel between the drain outlet port and the arterial connection port.

17. A blood circuit assembly and drain cassette for a dialysis unit, the blood circuit assembly comprising:

a pair of pneumatic pumps for circulating blood received from a patient through a circuit including a dialyzer unit and returned to the patient, the pneumatic pumps having pneumatic control ports arranged for alignment and mating with corresponding ports located on an exposed panel of the dialysis unit by pushing the control ports into engagement with the corresponding ports with mounting of the blood circuit assembly to the exposed panel;

an air trap arranged to remove air from blood circulating in the circuit;

a pair of dialyzer connections arranged to connect to the inlet and outlet of a dialyzer unit; and

a pair of blood line connectors, including an arterial blood line connector for receiving blood from the patient and providing blood to the pneumatic pumps and a venous blood line connector for returning blood to the patient;

the drain cassette comprising;

a venous connection port for connection to, and fluid communication with, the venous blood line connector;

an arterial connection port for connection to, and fluid communication with, the arterial blood line connector;

a fluid channel fluidly connecting the venous connection port and the arterial connection port;

a drain outlet port in fluid communication with the fluid channel and arranged to removably couple with a drain connector on an exposed panel of the dialysis unit; and

a valve arranged to control flow in the fluid channel,

wherein both the blood circuit assembly and the drain cassette are engageable with the exposed panel for operation in a dialysis treatment, and are removable from the exposed panel for replacement, without the use of tools.

18. The assembly and cassette of claim 17, further comprising flexible tubing fluidly connecting the pumps, the air trap, the dialyzer connections and the blood line connectors.

19. The assembly and cassette of claim 18, wherein the flexible tubing fluidly connects the arterial blood line connector to an inlet for the pump cassette, an outlet for the pump cassette to a dialyzer inlet connector, a dialyzer outlet connector to an inlet of the air trap, and an outlet of the air trap to the venous blood line connector.

20. The assembly and cassette of claim 17, wherein the blood line connectors are arranged for a threaded luer-type connection to a patient access, and are arranged for a press-in type connection to the drain cassette connection ports.

21. The assembly and cassette of claim 17, further comprising:

a check valve arranged to allow flow from the fluid channel and out of the drain outlet port and to resist flow from the drain outlet port to the fluid channel.

22. The assembly and cassette of claim 17, wherein the valve of the drain cassette is a pneumatically-controlled valve, the drain cassette further comprising:

a pneumatic control port arranged to removably mate with a port on the exposed panel and fluidly coupled to the valve to allow control of the valve.

23. The assembly and cassette of claim 17, further comprising:

a latch arranged to releasably lock the drain cassette to the exposed panel.

24. The assembly and cassette of claim 17, wherein the drain outlet port fluidly communicates with the fluid channel at a point above where the arterial and venous connection ports communicate with the fluid channel.

25. The assembly and cassette of claim 17, the drain cassette further comprising:

one or more sensors arranged to detect a characteristic of fluid in the fluid channel; and

an electrical connector arranged to electrically connect the one or more sensors to a corresponding electrical connector on the exposed panel,

wherein the electrical connector and the drain outlet port are arranged to simultaneously couple with a corresponding electrical connector and drain connector on the exposed panel in a single connection operation.

26. The assembly and cassette of claim 25, wherein the valve is a pneumatically-controlled valve, the drain cassette further comprising:

a pneumatic control port arranged to removably mate with a control port on the exposed panel, wherein the pneumatic control port is arranged to simultaneously couple with the corresponding control port in the single connection operation.

27. A blood circuit assembly for a dialysis unit, comprising:

a pair of pneumatic pumps for circulating blood received from a patient through a circuit including a dialyzer unit and returning the blood to the patient, the pneumatic pumps having pneumatic control ports arranged for alignment and mating with corresponding ports located on an exposed panel of the dialysis unit by pushing the control ports into engagement with the corresponding ports with mounting of the blood circuit assembly to the exposed panel;

an air trap arranged to remove air from blood circulating in the circuit;

a pair of dialyzer connections arranged to connect to the inlet and outlet of a dialyzer unit;

a pair of blood line connectors, including an arterial blood line connector for receiving blood from the patient and providing blood to the pneumatic pumps and a venous blood line connector for returning blood to the patient; and

flexible tubing fluidly connecting the pumps, the air trap, the dialyzer connections and the blood line connectors;

wherein the pumps are defined, at least in part, by a single unitary member that additionally defines a plurality of routing channels for at least a portion of the flexible tubing.

28. The blood circuit assembly of claim 27, wherein the single unitary member defines an air trap cavity that receives the air trap.

29. The blood circuit assembly of claim 27, further comprising an anticoagulant connection for engaging with an anticoagulant source and providing anticoagulant into the circuit.

30. The blood circuit assembly of claim 29, further comprising a pump for pumping anticoagulant from the anticoagulant source to the circuit.

31. The blood circuit assembly of claim 30, wherein the pair of pneumatic pumps, the anticoagulant connection, and the anticoagulant pump are part of a pump cassette.

32. The blood circuit assembly of claim 31, wherein the arterial blood line connector is connected to an inlet for the pump cassette, an outlet for the pump cassette is connected to a dialyzer inlet connector, a dialyzer outlet connector is connected to an inlet of the air trap, and an outlet of the air trap is connected to the venous blood line connector.

33. The blood circuit assembly of claim 29, wherein the anticoagulant connection includes a vial holder and a spike, and the anticoagulant source is a vial of heparin.

34. The blood circuit assembly of claim 27, wherein an inlet of the air trap is supported by the organizing tray at a position above an outlet of the air trap when the blood circuit assembly is mounted to a dialysis unit.

35. The blood circuit assembly of claim 27, wherein the pneumatic pumps are diaphragm pumps.

36. The blood circuit assembly of claim 27, wherein the blood line connectors are arranged for a threaded luer-type connection to a patient access, and are arranged for a press-in type connection to the dialysis unit.

37. The blood circuit assembly of claim 36, wherein the blood line connectors include a frustoconical member with an internal thread for the luer-type connection, and a central tube extending from a center of the frustoconical member.

38. The blood circuit assembly of claim 27, wherein the organizing tray includes circuit tube engagement members having a hole through which a respective circuit tube passes, the engagement members engaging with the respective circuit tube to allow the circuit tube to be pulled and stretched for engagement with an occluder of the dialysis unit.

39. The blood circuit assembly of claim 27, wherein the single unitary member defines the pneumatic control ports for the pumps.

40. The blood circuit assembly of claim 27, wherein the single unitary member defines a concave chamber portion for the pumps.

41. The blood circuit assembly of claim 27, wherein the single unitary member defines a chamber portion of a plurality of valves used to control flow through the pumps.

42. The blood circuit assembly of claim 27, wherein the single unitary member defines routing channels for flexible tubing to position the tubing for engagement with an occluder when the assembly is mounted to the dialysis unit.

43. A blood circuit assembly and drain cassette for a dialysis unit, the blood circuit assembly comprising:

an organizing tray;

a pair of pneumatic pumps attached to the organizing tray for circulating blood received from a patient through a circuit including a dialyzer unit and returning the blood to the patient;

an air trap attached to the organizing tray arranged to remove air from blood circulating in the circuit;

a pair of dialyzer connections fluidly connected to the air trap and the pumps and arranged to connect to the inlet and outlet of a dialyzer unit;

a pair of blood line connectors fluidly connected to the pumps and the air trap, including an arterial blood line connector for receiving blood from the patient and providing blood to the pneumatic pumps and a venous blood line connector for returning blood to the patient; and

flexible tubing fluidly connecting the pumps, the air trap, the dialyzer connections and the blood line connectors;

wherein the organizing tray engages with at least a portion of the flexible tubing to position the flexible tubing for mounting at an occluder position for interaction with an occluder of the dialysis unit, and wherein the organizing tray supports the air trap at a location that is above the occluder position.

44. The blood circuit assembly of claim 43, wherein the pumps are defined, at least in part, by a single unitary member that additionally defines a plurality of routing channels for at least a portion of the flexible tubing.

45. The blood circuit assembly of claim 43, wherein the pumps are defined, at least in part, by a single unitary member that additionally defines an air trap cavity that receives the air trap.

46. The blood circuit assembly of claim 43, wherein the pneumatic pumps having pneumatic control ports arranged for alignment and mating with corresponding ports located on an exposed panel of the dialysis unit by pushing the control ports into engagement with the corresponding ports with mounting of the blood circuit assembly to the exposed panel, and the single unitary member defines the pneumatic control ports for the pumps.

47. The blood circuit assembly of claim 43, wherein the single unitary member defines a concave chamber portion for the pumps.

48. The blood circuit assembly of claim 43, wherein the single unitary member defines a chamber portion of a plurality of valves used to control flow through the pumps.

49. The blood circuit assembly of claim 43, wherein the single unitary member defines routing channels for flexible tubing to position the tubing at the occluder position for engagement with an occluder when the assembly is mounted to the dialysis unit.

50. The blood circuit assembly of claim 43, wherein the arterial blood line connector is connected to an inlet for the pneumatic pumps, an outlet for the pneumatic pumps is connected to a dialyzer inlet connector, a dialyzer outlet connector is connected to an inlet of the air trap, and an outlet of the air trap is connected to the venous blood line connector.

51. The blood circuit assembly of claim 43, wherein an inlet of the air trap is supported by the organizing tray at a position above an outlet of the air trap when the blood circuit assembly is mounted to a dialysis unit.

52. The blood circuit assembly of claim 51, wherein the inlet of the air trap is supported by the organizing tray at a position above a highest point of flexible tubing that extends from the outlet of the air trap to the occluder position.

53. A blood circuit assembly engagement device for a dialysis unit, comprising:

an actuator movably mounted to a panel of the dialysis unit adjacent a plurality of control ports, the actuator movable between a retention position and an ejection position;

a retainer element coupled to the actuator and arranged, with the actuator in the retention position, to retain a blood circuit assembly mounted to the panel of the dialysis unit on the panel, and arranged, with the actuator in the ejection position, to release the blood circuit assembly for removal from the panel of the dialysis unit; and

an ejector element coupled to the actuator and arranged, with the actuator moved from the retention position to the ejection position, to urge the blood circuit assembly away from the panel.

54. The blood circuit assembly engagement device of claim 53, wherein the actuator is pivotally mounted to the panel.

55. The blood circuit assembly engagement device of claim 53, wherein the retainer element is fixed to the actuator.

56. The blood circuit assembly engagement device of claim 53, wherein the ejector element is pivotable between an inactive position and an ejection position.

57. The blood circuit assembly engagement device of claim 53, wherein the actuator is arranged to be moved from the retention position and the ejection position by a user'"'"'s thumb.

58. The blood circuit assembly engagement device of claim 53, comprising first and second blood circuit assembly engagement devices, the first engagement device arranged on a first side of a blood circuit assembly mounted to the panel, and the second engagement device arranged on a second side of the blood circuit assembly mounted to the panel, the first and second sides being opposed to each other such that the actuators of the engagement devices are movable by respective first and second thumbs of a user.

59. The blood circuit assembly engagement device of claim 58, wherein the actuators are movable away from each other from respective retention positions to ejection positions.

60. The blood circuit assembly engagement device of claim 53, wherein the ejection member is arranged to contact a portion of a pump chamber in the ejection position.

61. The blood circuit assembly engagement device of claim 53, wherein the retention element is arranged, with the actuator in the retention position and a blood circuit assembly mounted to the panel, to contact an outer surface of the blood circuit assembly to lock the blood circuit assembly in place.

62. The blood circuit assembly engagement device of claim 53, wherein the actuator is spring biased to move toward the retention position.

63. An occlusion assembly for occluding at least one pair of collapsible tubes of a medical infusion device, comprising:

for each pair of collapsible tubes, a first occluding member and a second occluding member, the first occluding member positioned adjacent to a first collapsible tube of the pair and the second occluding member positioned adjacent to a second collapsible tube of the pair, when the tubes are installed in the occlusion assembly for operation, the first occluding member and the second occluding member being further positioned adjacent from each other such that a space is defined between the first occluding member and the second occluding member, the space being on an opposite side of each occluding member than is the collapsible tube to which it is adjacent;

a spreader positioned within the space and movable within the space from a first position to a second position, wherein movement from the first position to the second position causes the spreader to force at least a portion of the first and second occluding members to move apart from each other to increase the size of the space and force a tube-contacting portion of each occluding member against the collapsible tube to which it is adjacent to occlude the collapsible tube; and

at least one actuator constructed and positioned to move the spreader between the first position and the second position.

71. The occlusion assembly of claim 63, further comprising a frame comprising a tubing guide configured for positioning the collapsible tubes and for mounting the first and second occluding members and spreader.

72. The occlusion assembly of claim 71, wherein the spreader is wedge shaped and coupled to the at least one actuator, and wherein the actuator causes the spreader to move in an essentially linear path from the first position to the second position to engage with the first and second occluding members and move apart them apart from each other.

74. The occlusion assembly of any one of claims 63, 66, and 68-73, wherein the occlusion assembly is configured so that the collapsible tubes are occluded in the absence of a force applied by the actuator to cause release of occlusion.

75. The occlusion assembly of claim 74, wherein the actuator comprises a biasing element configured to provide a restoring force causing occlusion of the collapsible tubes in the absence of positive actuation of the actuator to overcome the restoring force and release occlusion of the collapsible tubes.

80. The occlusion assembly or method of any of claims 63-79, wherein the occlusion assembly comprises a portion of a fluid handling assembly of a dialysis system.

81. The occlusion assembly or method of any of claims 63-80, wherein the occlusion assembly further comprises at least one collapsible tube mounted thereto.

82. The occlusion assembly of any one of claims 63, 66, and 68-79, comprising a pneumatically powered actuator.

64. A method of operating an occlusion assembly for occluding at least one pair of collapsible tubes of a medical infusion device, comprising:

moving a spreader of the occlusion assembly from a first position to a second position, wherein the spreader is positioned within a space defined between a first occluding member and a second occluding member, to cause the spreader to force at least a portion of the first and second occluding members to move apart from each other to increase the size of the space and force a tube-contacting portion of each occluding member against a collapsible tube to which it is adjacent to occlude the collapsible tube.

65. An occlusion assembly for occluding at least one collapsible tube of a medical infusion device, comprising:

a frame comprising a tubing guide configured for positioning the collapsible tube;

a tubing occluder mounted to the frame and comprising an occluding member constructed and positioned to controllably occlude or release occlusion of the collapsible tube;

a door hingeably mounted to the frame and positioned to cover at least a portion of the collapsible tube and tubing occlude when in a closed position and to provide user access to the collapsible tube when in an open position; and

a switch configured and positioned to detect when the door is in a closed position and to permit operation of the tubing occluder to release occlusion of the collapsible tube only when the door is in the closed position.

68. The occlusion assembly of claims 65 or 67, further comprising:

at least one actuator operatively coupled to the tubing occluder to cause an occluding member of the tubing occlude to move from an occluding position to a non-occluding position.

66. An occlusion assembly for occluding at least one collapsible tube of a medical infusion device, comprising:

a tubing occluder comprising an occluding member constructed and positioned to controllably occlude or release occlusion of the collapsible tube;

an automatic actuator operatively coupled to the tubing occluder to cause essentially linear motion of at least a portion of the tubing occluder to cause the occluding member to move from an occluding position to a non-occluding position; and

an override mechanism operatively coupled to the tubing occluder to cause essentially linear motion of at least a portion of the tubing occluder to cause the occluding member to move from an occluding position to a non-occluding position upon manual operation of the override mechanism by a user.

69. The occlusion assembly of any one of claims 66 or 68, wherein the occlusion assembly is configured for occluding at least a pair of collapsible tubes, and wherein the tubing occluder comprises for each pair of collapsible tubes:

a first occluding member and a second occluding member, the first occluding member positioned adjacent to a first collapsible tube of the pair and the second occluding member positioned adjacent to a second collapsible tube of the pair, when the tubes are installed in the occlusion assembly for operation, the first occluding member and the second occluding member being further positioned adjacent from each other such that a space is defined between the first occluding member and the second occluding member, the space being on an opposite side of each occluding member than is the collapsible tube to which it is adjacent; and

a spreader positioned within the space and movable within the space from a first position to a second position, wherein movement from the first position to the second position causes the spreader force at least a portion of the first and second occluding members to move apart from each other to increase the size of the space and force a tube-contacting portion of each occluding member against the collapsible tube to which it is adjacent to occlude the collapsible tube.

70. The occlusion assembly of claim 69, wherein the spreader is wedge shaped and coupled to the at least one actuator, and wherein the actuator causes the spreader to move in an essentially linear path from the first position to the second position to engage with the first and second occluding members and move apart them apart from each other.

73. The occlusion assembly of claims 70 or 72, wherein the first and second occluding members comprise occluder arms each having a proximal end pivotally mounted to the frame and a distal end comprising a tube contacting surface, and wherein movement of the spreader by the actuator caused each of the occluder arms to pivot such that their tube contacting surfaces move apart from each other and contact and compress a collapsible tube.

76. The occlusion assembly of claim 66, wherein the override mechanism comprises a user engageable manual actuator that is operatively coupled to a carriage assembly to which is also operatively coupled the automatic actuator and an occluding member engaging element configured to move the occluding member into the occluding position or permit the occluding member to move into the non-occluding position upon essentially linear motion movement of the carriage assembly, such that either engagement of the manual actuator by a user or actuation of the automatic actuator causes the essentially linear movement of the carriage assembly.

77. The occlusion assembly of claim 76, wherein the user engageable manual actuator comprises a push button forming part of, connected to, or operatively coupled with a lever that is operatively coupled to the carriage assembly and configured to cause the essentially linear movement of the carriage assembly when a user pushes the push button.

67. An occlusion assembly for occluding at least one collapsible tube of a medical infusion device, comprising:

a frame comprising a tubing guide configured for positioning the collapsible tube;

a tubing occluder mounted to the frame and comprising an occluding member constructed and positioned to controllably occlude or release occlusion of the collapsible tube;

a door hingeably mounted to the frame and positioned to cover at least a portion of the collapsible tube and tubing occluder when in a closed position and to provide user access to the collapsible tube when in an open position; and

a retainer mechanism engaged by the door when the door is in the closed position and configured to permit operation of the tubing occluder to occlude or release occlusion of the collapsible tube when the door is in the closed position and configured to engage and retain the tubing occluder in a non-occluding configuration when the door is opened while the tubing occluder is positioned in the non-occluding configuration.

78. The occlusion assembly of claim 67, wherein the tubing occluder comprises a carriage assembly slidably mounted to the frame, and wherein the carriage assembly,

i. is operatively coupled to an actuator that is configured to cause sliding motion of the carriage assembly,

ii. is operatively coupled to an occluding member engaging element configured to move the occluding member into an occluding position or permit the occluding member to move into a non-occluding position upon sliding motion of the carriage assembly, and

iii. comprises a latching pin.

79. The occlusion assembly of claim 78, further comprising a retention member movably mounted to the frame, the retention member comprising a surface configured and positioned to be engaged by a portion of the door when the door is in the closed position, the retention member further comprising a latching pin receiving hole sized and positioned to allow substantially unrestricted entry of the latching pin into the latching pin receiving hole upon sliding motion of the carriage assembly in a direction to permit the occluding member to move into the non-occluding position and exit of the latching pin from the latching pin receiving hole upon sliding motion of the carriage assembly in a direction move the occluding member into the occluding position when the door is in the closed position, wherein the retention member is biased for movement upon opening of the door to cause the latching pin receiving hole to move into engaging and retaining contact with the latching pin when the carriage assembly is positioned in its non-occluding position when the door is open.