Fluid delivery system with autoconnect features

• US 7,955,295 B2
• Filed: 07/05/2007
• Issued: 06/07/2011
• Est. Priority Date: 07/05/2007
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Biewer, John, Gilbert, Richard R. II, Orand, Austin J., Kopychev, Andrey, Foohey, Mark W., Murphey, Randy, Lee, Patrick, Childers, Robert W., Reitz, Douglas, Steck, John Edward, Roger, Rodolfo
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Gilbert; Andrew M
• Application Number:
  US11/773,523
• Publication Number:
  US 20090012449A1
• Time in Patent Office: 1,433 Days
• Field of Search: 604/29, 604533-536, 604/538, 604/905, 138/89, 138/96.R
• US Class Current: 604/29
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/153 the cassette being adapted for heating or cooling the treating fluid, e.g. the dialysate or the treating gas
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/284 Continuous flow peritoneal dialysis [CFPD]
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/58 Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 39/18 Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16813 by controlling the degree of opening of the flow line
• CPC Class Codes: Y10T 137/6116 With holding means functioning only during transportation assembly or disassembly
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

A fluid dispensing machine, such as a peritoneal dialysis or hemodialysis machine, includes a dispenser or cassette that pumps a medical fluid for dialysis or other treatments for patients. The machine includes and uses an autoconnect device for connecting containers of liquid, such as bags of dialysis fluid or medication fluids, to the machine, while maintaining the sterility of the connection. The autoconnect device removes the cap from the fluid bag and pierces the scaling membrane on tubing from the bag. This makes it easier for patients to receive treatment, especially home treatment. Other embodiments are useful for dispensing other liquids from other types of dispensing or pumping machines.

Claims

1. A system for automatically connecting tubing while maintaining sterility, the system comprising:

a frame for mounting adjacent a cassette in a dialysis machine;

a shuttle mounted within the frame, the shuttle configured for receiving tubing from at least two containers, the tubing including a cap;

a shuttle driving system for translating the shuttle within the frame;

at least two rotating fingers configured for receiving and removing the caps, the fingers mounted to the frame and operably adjacent the shuttle;

a finger rotating system configured for rotating the fingers in a plane parallel to a direction of travel of the shuttle; and

a control system for operating the system for automatically connecting tubing,

wherein the system for automatically connecting tubing is configured for receiving sterile tubing from at least two containers, the fingers are configured for receiving caps from the tubing, the shuttle is configured for advancing the ends of the tubing, the control system is configured to rotate the fingers to remove the caps, and the cassette comprises at least two spikes for piercing sterile sealing membranes of the tubing and making a sterile connection.

2. The system of claim 1, wherein the shuttle driving system is selected from the group consisting of a motor and two lead screws, two pneumatic cylinders, two solenoids, and two hydraulic cylinders.

3. The system of claim 1, wherein the finger rotating system comprises a motor and a first shaft, and a second shaft connected to the at least two rotating fingers, the second shaft driven by a driving system selected from the group consisting of:

i. a worm on the first shaft and a worm gear on the second shaft;

ii. helical gears on the first and second shafts; and

iii. bevel gears on the first and second shafts.

4. The system of claim 1, further comprising an occluder and an occluder driver mounted on the frame, the occluder configured for translating in a direction perpendicular to the shuttle, and the occluder also configured for pinching the tubing.

5. The system of claim 1, further comprising a filter, a blower and a housing for containing at least the frame and the shuttle, the blower configured to provide clean air from the filter to maintain a positive air pressure within the housing.

6. The system of claim 1, wherein a top surface of the shuttle further comprises a plurality of channels for receiving the tubing, each channel optionally comprising at least one of a radio-frequency reader and a collar plate.

7. The system of claim 1, wherein each rotating finger comprises a housing having a first set of gripping fingers and a first cap pocket for grasping a cap from the tubing and a second set of gripping fingers and a second cap pocket for grasping a cap from a dialysis cassette, each rotating finger also comprising an orifice for admitting and interfacing with a drive shaft configured for rotating the rotating finger.

8. The system of claim 7, wherein each first set of gripping fingers is configured to grasp a cap from the tubing at least over about 180°

of a periphery or inner periphery of the cap.

9. The system of claim 1, wherein a housing for each rotating finger comprises two halves with an ejector plate mounted between the halves, and the frame comprises a plurality of cam surfaces for interfacing with the ejector plates.

10. The system of claim 1, wherein each rotating finger further comprises at least one spring mounted within the finger, an extension spring bearing against a portion of an ejector plate, the extension spring configured to return the ejector plate to a resting position, or a leaf spring configured to bias the rotating finger for rotation.

11. The system of claim 1, further comprising a disposable dialysis cassette with a plurality of apertures for dialysis fluid, each aperture comprising a spike, the spike configured to be recessed within the aperture.

12. The system of claim 1, further comprising a disposable dialysis cassette with a plurality of spiked apertures for dialysis fluid, at least one spiked aperture for tubing to and from a patient, and a spiked aperture for a drain line, wherein the shuttle is configured for autoconnection of tubing to each of the apertures.

13. The system of claim 1, further comprising a dialysis machine and a disposable cassette for interfacing with the system for automatically connecting tubing, the disposable cassette comprising a plurality of spikes and apertures for interfacing with tubing, the dialysis machine configured for pumping dialysis fluid, operating the disposable cassette and the system for automatically connecting tubing from sterile containers of dialysis fluid.

14. The system of claim 1, wherein the shuttle further comprises a plurality of channels for receiving the tubing, each channel comprising a radio-frequency reader for reading an RFID tag on the tubing, and further comprising a computer and computer program accessible to the control system, the computer configured to receive identification signals from the RFID readers and the computer program configured to alert a user of the system if placement of the tubing into the channels is incorrect.

15. The system of claim 1, wherein the shuttle further comprises a plurality of channels for receiving the tubing and further comprising an RFID reader or bar code reader operably connected to the autoconnect device, the RFID reader or bar code reader configured to read a bar code or RFID tag on the tubing or on the containers, and further comprising a computer and computer program accessible to the control system, the computer configured to receive identification signals from the RFID reader or the bar code reader and the computer program configured to instruct a user of the system on which channel to place each tubing.

16. A system for automatically connecting sterile tubing, the system comprising:

a frame for mounting adjacent a cassette in a dialysis machine;

a shuttle mounted within the frame, the shuttle comprising a tubing side and a cassette side, the shuttle configured for receiving tubing from a plurality of sterile containers of dialysis fluid, each container including a length of tubing and a cap;

a shuttle driving system for translating the shuttle within the frame;

a plurality of rotating fingers, each rotating finger configured for receiving and removing the cap from the length of tubing and configured for receiving and removing a cassette port cap, the rotating fingers mounted to the frame and adjacent the shuttle;

a finger rotating system including a shaft configured for rotating the fingers in a plane parallel to a direction of travel of the shuttle; and

a control system for operating the system for automatically connecting tubing,

wherein the system for automatically connecting tubing is configured for receiving tubing of a plurality of containers of dialysis fluid, the fingers configured for receiving caps from the tubing and cassette port caps, and the control system configured to translate the shuttle, to rotate the fingers, and to advance ends of the tubing into an adjacent cassette, the cassette comprising at least two spikes for piercing sealing membranes of the tubing and making a sterile connection.

17. The system of claim 16, further comprising an occluder and an occluder motor mounted on the shuttle, and further comprising at least one lead screw configured for driving the occluder with the motor, the occluder optionally comprising a spring for biasing a position of the occluder.

18. The system of claim 16, further comprising at least one of i. an optical sensor, encoder, or proximity sensor for detection of a position of the shuttle;

and ii. a sensor or an encoder for detecting a position of the fingers or the finger rotating shaft.

19. The system of claim 16, wherein a top surface of the shuttle further comprises a plurality of channels for receiving the lengths of tubing, each channel comprising a radio-frequency identification tag reader, and wherein the control system is configured to recognize a radio-frequency identification tag from each of the lengths of tubing.

20. The system of claim 16, further comprising a plurality of radio-frequency identification tags and radio-frequency identification tag housings for the tags, each tag housing configured for placement on the tubing and on the shuttle.

21. The system of claim 16, wherein each of the rotating fingers comprises an RFID reader for reading an RFID chip on the tubing cap, the RFID readers in communication with the control system.

22. The system of claim 16, further comprising a camera or a bar code reader operably connected to the control system.

23. The system of claim 16, wherein the shuttle further comprises a plurality of collars protruding from the cassette side, and wherein the shuttle, the fingers, and the caps from the tubing are configured for rotating the fingers away from the shuttle only in those fingers containing a cap from the tubing.

24. The system of claim 16, further comprising a fluid flow sensor mounted near the tubing and operably connected to the control system, the fluid flow sensor optionally selected from the group consisting of an optical sensor, a pressure sensor, and a flow sensor.

25. The system of claim 16, further comprising at least one of a flow sensor, pH sensor, or conductivity sensor operably connected to the control system.

26. A system for automatically connecting tubing, the system comprising:

a frame for mounting adjacent a dispensing machine;

a shuttle mounted within the frame, the shuttle comprising a tubing side and a dispensing side, the shuttle configured for receiving tubing from a plurality of containers;

a shuttle driving system for translating the shuttle within the frame;

a plurality of rotating fingers, each rotating finger configured for receiving and removing a tubing cap and also configured for receiving and removing a dispensing machine port cap, the rotating fingers mounted to the frame and adjacent the shuttle;

a finger rotating system including a shaft configured for rotating the fingers in a plane parallel to a direction of travel of the shuttle; and

a control system for operating the system for automatically connecting tubing,

wherein the system for automatically connecting tubing is configured for receiving tubing of a plurality of containers of liquid, the fingers configured for receiving tubing caps and dispensing machine port caps, and the control system is configured to translate the shuttle, to rotate the fingers, and to advance ends of the tubing into an adjacent dispensing machine, the dispensing machine comprising at least two spikes for piercing sealing membranes of the tubing.

27. The system of claim 26, further comprising at least one of an RFID reader, a bar code reader, or a camera operably connected to the control system.

28. The system of claim 26, further comprising a dispensing machine operably connected to the system for automatically connecting tubing.

29. The system of claim 26, wherein the finger rotating system comprises a shaft connected to the at least two rotating fingers, the shaft driven by a motor and a shaft driving system selected from the group consisting of a worm and a worm gear, helical gears, and bevel gears.

30. The system of claim 26, further comprising a dispensing machine with a plurality of apertures for the tubing and for liquid from the containers, each aperture comprising a spike, the spike configured to be recessed within the aperture.

31. The system of claim 26, further comprising a dispensing machine with a plurality of apertures for the tubing and for liquid from the containers, each aperture comprising a stepped spike recessed within the aperture.

32. The system of claim 26, wherein the shuttle further comprises a plurality of channels for receiving the tubing, each channel comprising a radio-frequency reader for reading an RFID tag on the tubing, and further comprising a computer and computer program accessible to the control system, the computer configured to receive identification signals from the RFID readers and the computer program configured to alert a user of the system if placement of the tubing into the channels is incorrect.

33. The system of claim 26, wherein the shuttle further comprises a plurality of channels for receiving the tubing and further comprising an RFID reader or bar code reader operably connected to the autoconnect device, the RFID reader or bar code reader configured to read a bar code or RFID tag on the tubing or on the containers, and further comprising a computer and computer program accessible to the control system, the computer configured to receive identification signals from the RFID reader or the bar code reader and the computer program configured to instruct a user of the system on which channel to place each tubing.

34. The system of claim 26, wherein the fingers further comprise radio-frequency readers for reading an RFID tag on the cap of the tubing, and further comprising a computer and computer program accessible to the control system, the computer configured to receive identification signals from the RFID readers and the computer program configured to alert a user of the system device if placement of the tubing into the channels is incorrect.

35. The system of claim 26, wherein the tubing or the caps of the tubing further comprise an identifier selected from the group consisting of an RFID tag, a bar code indicia, a stamping, a laser marking, a printing, and an etching.

36. A system for automatically connecting tubing, the system comprising:

a frame for mounting adjacent a dispensing machine;

a platform mounted within the frame, the platform comprising a tubing side and a dispensing side, the platform configured for receiving tubing from a plurality of containers;

a plurality of moving mounts on the platform, each mount further comprising a driving system for advancing and retracting the mount;

a plurality of rotating fingers, each rotating finger configured for receiving and removing a tubing cap and also configured for receiving and removing a dispensing machine port cap, the rotating fingers mounted to the frame and adjacent the platform;

a finger rotating system including a shaft configured for rotating the fingers in a plane parallel to a direction of travel of the mounts; and

a control system for operating the system for automatically connecting tubing,

wherein the system for automatically connecting tubing is configured for receiving tubing from a plurality of containers of liquid, the fingers are configured for receiving tubing caps and dispensing machine port caps, and the control system is configured to translate the mounts individually, to rotate the fingers, and to advance ends of the tubing into an adjacent dispensing machine, the dispensing machine comprising at least two spikes for piercing sealing membranes of the tubing.

37. The system of claim 36, wherein the driving systems are selected from the group consisting of an electric motor-driven system, a solenoid, an air cylinder, and a pneumatic cylinder.

38. The system of claim 36, further comprising at least one of an RFID reader, a bar-code reader, and a camera operably connected to the control system.

39. The system of claim 36, further comprising at least one of a flow sensor, a pH sensor, and a conductivity sensor operably connected to the control system.

40. The system of claim 36, further comprising a plurality of RFID readers in the mounts or in the rotating fingers.

41. The system of claim 36, further comprising a dispensing machine with a plurality of apertures for the tubing and for liquid from the containers, each aperture comprising a spike, the spike configured to be recessed within the aperture.

42. The system of claim 36, further comprising a dispensing machine for interfacing with the system for automatically connecting tubing, the dispensing machine comprising a plurality of spikes and apertures for interfacing with tubing, and the dispensing machine configured for pumping liquid from the containers.

43. The system of claim 36, wherein the mounts further comprise an RFID reader for reading an RFID tag on the tubing, and further comprising a computer and computer program accessible to the control system, and the computer is configured to receive identification signals from the RFID readers and the computer program configured to alert a user of the system if placement of the tubing into the platforms is incorrect.

44. The system of claim 36, further comprising an RFID reader or bar code reader operably connected to the system, the RFID reader or bar code reader configured to read a bar code or RFID tag on the tubing or on the containers, and further comprising a computer and computer program accessible to the control system, the computer configured to receive identification signals from the RFID reader or the bar code reader and the computer program configured to instruct a user of the system on which mount to place each tubing.

45. The system of claim 36, further comprising at least one of i. an optical sensor, encoder, or proximity sensor for detection of a position of the mounts;

and ii. a sensor or an encoder for detecting a position of the fingers or the finger rotating shaft.

46. A method for connecting dialysis bags to a dialysis cassette, the method comprising:

placing tubing from a dialysis bag into a shuttle of an autoconnect machine, the autoconnect machine comprising a frame, a shuttle and shuttle driving system mounted on the frame, a plurality of rotating fingers, each finger configured for receiving a cap from dialysis bag tubing, and a finger rotating system for rotating the fingers, and wherein the tubing fits into tubing runs atop the shuttle;

placing the tubing cap into a first pocket of one of the rotating fingers of the autoconnect machine, causing the rotating finger with the tubing cap to rotate in a direction away from the shuttle and toward a disposable cassette on an opposite side of the rotating fingers;

translating the shuttle a distance in a direction toward the disposable cassette, wherein translating the shuttle rotates or translates the rotating finger with the tubing cap, and causes only the rotating finger into which the tubing cap was placed to capture a port cap from a port of the disposable cassette in a second pocket of the rotating finger;

translating the shuttle in a direction away from the cassette, removing the tubing cap from the dialysis bag and leaving the tubing cap in the first pocket;

rotating the rotating fingers in a direction toward the shuttle, removing the port cap from the port of the dialysis cassette while retaining the port cap in the second pocket; and

translating the shuttle toward the dialysis cassette and causing a spike in the port of the disposable cassette to pierce a sealing membrane in the tubing.

47. The method of claim 46, wherein the method is suitable for peritoneal dialysis or hemodialysis.

48. The method of claim 46, wherein the step of rotating the fingers causes an ejector plate within the rotating finger to advance and push the tubing cap out of the first pocket and to push the port cap from the rotating finger.

49. The method of claim 46, wherein the tubing further comprises a radio-frequency identification tag, and further comprising reading the radio-frequency identification tag when the tubing is placed into the shuttle.

50. The method of claim 46, wherein the dialysis bag further comprises a bar code indicia and further comprising reading the bar code when the tubing is placed into the shuttle.

51. The method of claim 46, further comprising operating the autoconnect machine automatically after the steps of placing tubing and placing the cap.

52. The method of claim 46, wherein an inside of the tubing of the dialysis bag and an inner portion of the dialysis cassette port are sterile, and a sterile connection is maintained in connecting the dialysis bag to the dialysis cassette.

53. The method of claim 46, further comprising sensing a position of the shuttle with a sensor on the shuttle or on the frame or sensing a position of the occluder with a sensor on the occluder or on the shuttle.

54. The method of claim 46, wherein the tubing is placed into separate positions on the shuttle and further comprising reading RFID tags on the tubing with RFID readers in the positions, and further comprising alerting a user of the autoconnect machine if placement of the tubing into the positions is incorrect.

55. The method of claim 46, wherein the tubing is placed onto separate positions on the shuttle and wherein the tubing or the bag has a unique identifier, and further comprising reading the unique identifier with a bar code reader, a camera, or an RFID reader, and further comprising instructing a user of the autoconnect machine in which position to place the tubing.

56. The method of claim 46, further comprising filtering air and blowing the air into a protective housing to maintain a clean atmosphere for at least the autoconnect machine and the dialysis cassette.

57. A method for connecting fluid containers, the method comprising:

placing a connector from a fluid container into an autoconnect machine;

placing a tubing cap from one of the fluid containers into a pocket of one of a plurality of fingers of the autoconnect machine, causing the finger to move or rotate in a direction toward a dispensing machine on a different side of the fingers;

translating the tubing and the tubing cap a distance in a direction toward the dispensing machine, wherein translating rotates the plurality of fingers and causes only the finger into which the tubing cap was placed to capture a port cap from a port of the dispensing machine;

translating the tubing in a direction away from the dispensing machine, removing the tubing cap from the tubing and leaving the tubing cap from the tubing in the pocket;

rotating the fingers away from the dispensing machine and in a direction to remove the port cap from the port of the dispensing machine; and

translating the tubing toward the dispensing machine and causing a spike in the port of the dispensing machine to pierce a sealing membrane in the tubing.

58. The method of claim 57, wherein the fluid is selected from the group consisting of dialysis fluid, blood, a blood substitute, nutritional fluids, fluids containing a medication, and saline.

59. The method of claim 57, further comprising operating the autoconnect machine automatically after the steps of placing tubing and placing the tubing cap.

60. The method of claim 57, wherein a seal is formed between a stepped portion of the spike and the tubing just before the spike pierces the sealing membrane.

61. The method of claim 57, wherein a seal is formed between a stepped portion of the spike and an entrance to the tubing after the spike pierces the sealing membrane.

62. The method of claim 57, further comprising sensing a flow with a flow sensor.

63. The method of claim 57, wherein the tubing is placed into separate areas on the autoconnect machine and further comprising reading RFID tags on the tubing with RFID readers in the separate areas, and further comprising alerting a user of the autoconnect machine if placement of the tubing into the areas is incorrect.

64. The method of claim 57, wherein the tubing is placed onto separate positions within the autoconnect machine and wherein the tubing or the bag has a unique identifier, and further comprising reading the unique identifier with a bar code reader, a camera, or an RFID reader, and further comprising instructing a user of the the autoconnect machine in which position to place the tubing.

65. The method of claim 57, further comprising sensing a property of the fluid with at least one of a pH meter, a conductivity meter, and a temperature element.