Automated medical liquid filling system and method

• US 7,997,304 B2
• Filed: 12/01/2006
• Issued: 08/16/2011
• Est. Priority Date: 12/02/2005
• Status: Active Grant

• Current Assignee: Baxter Corporation Englewood (Baxter International Inc.)
• Original Assignee: BAXA Corporation (Baxter International Inc.)
• Inventors: Hutchins, Loren Havener IV, Olichney, Michael Dickson, Ranalletta, Joseph Vincent, Aumiller, Joshua Nathan
• Primary Examiner(s): Huson; Gregory L
• Assistant Examiner(s): ARNETT, NICOLAS ALLEN
• Application Number:
  US11/565,744
• Publication Number:
  US 20070215235A1
• Time in Patent Office: 1,719 Days
• Field of Search: 141/2, 141/18, 141 25- 27, 141/95, 141/104, 141/318, 604/407
• US Class Current: 141/25
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61M 2005/3114 Filling or refilling
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

Abstract

A medical liquid filling system and associated methods are provided, the system comprising a disposable and a drive system. The disposable includes a tubular member and a piston slidably disposed within the tubular member for retraction and advancement within at least a first portion of the tubular member. The disposable may include a seal member for sealing the first portion of the tubular member and may be interconnected to the piston for co-movement therewith. The drive system may include a piston drive member selectively interconnectable to the piston for driven advancement and retraction of the piston within the tubular member. The drive system may be interconnected to a controller, which may be operable to automate or semi-automate various filling operations. A user interface may be interconnected to the controller for providing input of various system operation parameters, which may be communicated to the controller to facilitate automated or semi-automated operation of the filling system.

Claims

1. A system for automated filling of at least one interconnectable receptacle with a medical liquid, comprising:

a disposable, including;

a tubular member;

a piston slidably disposed in said tubular member for retraction and advancement within at least a first portion of said tubular member, wherein said piston is positionable to at least a first piston position and to a second piston position within said tubular member;

a seal member for sealing a distal end of said tubular member, wherein said seal member is interconnected to said piston for co-movement therewith and slidable engagement within a second portion of said tubular member, said second portion being located distal to said first portion, wherein said tubular member further comprises a third portion located distal to said second portion, wherein said second and third portions are each cylindrical and have second and third diameters, respectively, and wherein said third diameter is greater than said second diameter; and

,

a first connection member interconnected to said seal member; and

,

an automated drive system, including;

a piston drive member including a second connection member selectively interconnectable to said first connection member for driven advancement and retraction of said piston within said tubular member, wherein said piston drive member of the automated drive system is operable to draw a predetermined volume of a medical liquid into said tubular member and to dispense at least a portion of said predetermined volume of medical liquid from the tubular member into at least one interconnectable receptacle, and wherein said piston drive member of the automated drive system is selectively disconnectable from said piston.

2. A system as recited in claim 1, wherein said first and second portions of said tubular member are each cylindrical and have first and second diameters, respectively, and wherein said second diameter is greater than said first diameter.

3. A system as recited in claim 1, wherein said seal member is spaced from said piston by a fixed distance that is at least as great as a length of said first portion of said tubular member.

4. A system as recited in claim 1, wherein said first connection member comprises:

one of a complimentary male member and female member; and

said second connection member comprises;

the other of said complimentary male member and female member, wherein said male member is insertable into and restrainably engageable by said female member.

5. A system as recited in claim 4, wherein said female member comprises a plurality of fingers for receiving and restrainably engaging said second connection member therebetween.

6. A system as recited in claim 1, said automated drive system further comprising:

a drive motor comprising;

a moveable output member interconnectable to said piston drive member;

a magnetic field member for inducing movement of said output member; and

a sensor for sensing a position of said moveable output member in relation to said magnetic field member and for providing an output signal in corresponding relation thereto;

wherein said system further comprises;

a controller for controlling said drive motor via said magnetic field member using said output signal of said sensor.

7. A system of claim 6, wherein said controller is operable to control said drive motor in relation to a predetermined fill-related value to control the pressure within said tubular member.

8. A system of claim 7, wherein said fill-related value comprises one or more pressure parameters.

9. A system of claim 7, wherein said controller is operable to control said drive motor to control the pressure within said tubular member free from input relating to a fluid-type parameter.

10. A system of claim 7, wherein said drive motor comprises a brushless DC motor.

11. A system as recited in claim 1, said automated drive system further including:

a mount for selectively, restrainably engaging said disposable in a fixed position relative to said piston drive member.

12. A system as recited in claim 11, said mount including:

at least one bearing surface for engaging a first portion of said disposable, wherein as engaged, said bearing surface restricts movement of said disposable in at least a first direction.

13. A system as recited in claim 12, said mount including:

an engagement surface for engaging a second surface portion of said disposable, wherein said engagement surface and said second surface portion comprise corresponding concave surfaces.

14. A system as recited in claim 13, said mount comprising:

a cradle disposed between said bearing surface and said engagement surface, wherein said cradle is adapted to restrict movement of said disposable in at least a second direction.

15. A system as recited in claim 1, said disposable further including:

a first connection member interconnected to said seal member; and

said piston drive member including;

a second connection member, wherein said first and second connection members are selectively interconnectable and disconnectable.

16. A system as recited in claim 15, wherein one of said first connection member and said second connection member includes:

a bulbous end portion; and

wherein the other of said first connection member and said second connection member includes;

a plurality of expandable fingers spaced about a ring for receiving and restrainably engaging said first connection member therebetween.

17. A system as recited in claim 1, further comprising:

a controller interconnectable to said piston drive member; and

a user interface interconnectable to said controller, said user interface being adapted to receive input corresponding to system operation parameters and operable to communicate such system operation parameters to said controller for use by said controller.

18. A system as recited in claim 17, wherein said system operation parameters comprise one or more of a continuous transfer mode parameter, a medical liquid source volume parameter, a pressure parameter, a speed parameter, a fluid direction parameter, a unit volume parameter, a time delay parameter, a lot size parameter, and a drawback parameter.

19. A system as recited in claim 17, wherein said system operation parameters comprise one or more of a fluid-type parameter, a disposable size parameter, a receptacle type parameter and fluid line parameter.

20. A system as recited in claim 17, wherein said user interface comprises a graphics portion adapted to display instructions associated with the operation of the system.

21. A system as recited in claim 17, wherein said user interface comprises a multi-function button adapted to display a plurality of indicators and accept input relating to each ones of said plurality of indicators.

22. A system as recited in claim 1, wherein said tubular member is substantially non-deformable.

23. A system as recited in claim 1, wherein said seal member is spaced from said piston by a fixed distance that is greater than a length of said first portion of said tubular member.

24. A system as recited in claim 1, wherein said piston comprises:

a resilient member, wherein in said first piston position said resilient member is positioned within and sealably engages said first portion of said tubular member.

25. A system as recited in claim 24, wherein in said first piston position said resilient member is compressed to a first degree of compression, wherein in said second piston position said resilient member is compressed to a second degree of compression, wherein said first degree of compression is greater than said second degree of compression.

26. A system as recited in claim 1, wherein said piston is positionable to a third piston position, and wherein said seal member comprises:

a resilient member, wherein in said first piston position said resilient member is compressably positioned within and sealably engages said second portion of said tubular member, and wherein in said first piston position said resilient member is compressed to a first degree of compression, wherein in said third piston position said resilient member is compressed to a second degree of compression, wherein said first degree of compression is greater than said second degree of compression.

27. A system as recited in claim 1, wherein said first and second connection members are selectively interconnectable in aligned relation with said tubular member and said piston drive member.

28. A system for automated filling of at least one interconnectable receptacle with a medical liquid, comprising:

a disposable, including;

a tubular member;

a piston slidably disposed in said tubular member for retraction and advancement within at least a first portion of said tubular member;

a seal member for sealing a distal end of said tubular member; and

,

a first connection member interconnected to said member; and

an automated drive system, including;

a piston drive member selectively interconnectable to said piston for driven advancement and retraction of said piston within said tubular member, wherein said piston drive member of the automated drive system is operable to draw a predetermined volume of a medical liquid into said tubular member and to dispense at least a portion of said predetermined volume of medical liquid from the tubular member into at least one interconnectable receptacle, and wherein said piston drive member of the automated drive system is selectively disconnectable from said piston; and

,

a second connection member, wherein said first and second connection members are selectively interconnectable and disconnectable, and wherein said first and second connection members are restrainably interconnected when collocated within said second portion of said tubular member.

29. A system as recited in claim 28, wherein in said first piston position said first and second connection members are restrainably interconnected.

30. A system as recited in claim 29, wherein in said first piston position at least a portion of said piston is positioned within said first portion of said tubular member and at least a portion of said seal member is positioned within said second portion of said tubular member.

31. A system as recited in claim 29, wherein in said second piston position said first and second connection members are disconnectable.

32. A system as recited in claim 31, wherein in said second piston position at least a portion of said piston is positioned within said second portion of said tubular member.

33. A system for automated filling of at least one interconnectable receptacle with a medical liquid, comprising:

a disposable including;

a tubular member;

a piston slidably disposed in said tubular member for retraction and advancement within at least a first portion of said tubular member, wherein said piston is positionable to at least a first piston and to a second piston position within said tubular member;

a seal member for sealing a distal end of said tubular member, wherein said seal member is interconnected to said piston for co-movement therewith and slidable engagement within a second portion of said tubular member, said second portion being located distal to said first portion; and

,

a valve fluidly interconnected to said tubular member proximal to said piston, said valve including a valve housing, fixedly interconnected to said tubular member, and a valve stem slidably disposed within said valve housing, wherein in a first valve position a first valve port is fluidly interconnected to said tubular member, and wherein in a second valve position a second valve port is fluidly interconnected to said tubular member; and

an automated drive system, including;

a piston drive member selectively interconnectable to said piston of said disposable for driven advancement and retraction of said piston within said tubular member, wherein said piston drive member of the automated drive system is operable to draw a predetermined volume of a medical liquid into said tubular member of said disposable and to dispense at least a portion of said predetermined volume of medical liquid from the tubular member of said disposable into at least one interconnectable receptacle, and wherein said piston drive member of the automated drive system is selectively disconnectable from said piston of said disposable; and

,

a valve drive member selectively interconnectable to and disconnectable from said valve of said disposable for automated, alternate positioning of said valve in said first valve position and said second valve position.

34. A system as recited in claim 33, wherein said valve stem is rotatably disposed within said valve housing.

35. A system as recited in claim 34, said valve drive member including:

one of at least a first projection and a first opening; and

,

said valve stem including;

the other one of said at least a first projection and a first opening.

36. A system as recited in claim 35, said valve stem including:

at least first and second channels, wherein said first channel fluidly connects said first valve port and said tubular member only when said valve is in said first valve position, and wherein said second channel fluidly interconnects said second valve port and said tubular member only when said valve is in said second valve position.

37. A system as recited in claim 36, wherein said valve stem comprises:

a stop portion, wherein in a third valve position said stop portion restricts fluid communication between said first port and between said tubular member and said second valve port and said tubular member.

38. A system as recited in claim 36, wherein said first and second channels comprise arcuate paths disposed about a perimeter of said valve stem.

39. A system as recited in claim 38, wherein said valve stem perimeter is defined in part by said first and second channels.

40. A system as recited in claim 33, said drive system further including:

at least one drive motor interconnected to said piston drive member;

a reference member;

a sensor for sensing at least one degree of relative movement between said piston drive member and the reference member for providing an output signal; and

,

a controller for receiving said output signal and providing a control signal to said at least one drive motor in response thereto.

41. A system as recited in claim 40, wherein said at least one drive motor is interconnected to said valve drive member, and wherein in response to said output signal said controller is operative to provide a control signal to said at least one drive motor to change said valve from one of said first and second valve positions to the other of said first and second valve positions.

42. A system as recited in claim 40, wherein said at least one drive motor is adapted to automatically provide a maximum force to said piston drive member that yields an internal pressure within said disposable that is less than a predetermined amount.

43. A system as recited in claim 33, said disposable further comprising:

a first fluid line interconnected at one end to said first valve port and interconnectable at another end to at least a first medical liquid source; and

a second fluid line interconnected at one end to said second valve port and interconnectable at another end to at least one vessel, wherein said system is operative to pump a medical liquid through said first fluid line, said tubular member, and said second fluid line free from occlusion of said first and second fluid lines.

44. A system for automated filling of at least one interconnectable receptacle with a medical liquid, comprising:

a disposable, including;

a tubular member;

a piston slidably disposed in said tubular member for retraction and advancement within at least a first portion of said tubular member, wherein said piston is positionable to at least a first piston and to a second piston position within said tubular member; and

,

a seal member for sealing a distal end of said tubular member, wherein said seal member is interconnected to said piston for co-movement therewith and slidably engagement within a second portion of said tubular member, said second portion being located distal to said first portion; and

a first connection member interconnected to said seal member, wherein said first connection member comprises one of a complimentary male member and female member; and

,

an automated drive system, including;

a piston drive member including a second connection member selectively interconnectable to said first connection member for driven advancement and retraction of said piston within said tubular member, wherein said piston drive member of the automated drive system is operable to draw a predetermined volume of a medical liquid into said tubular member and to dispense at least a portion of said predetermined volume of medical liquid from the tubular member into at least one interconnectable receptacle, wherein said piston drive member of the automated drive system is selectively disconnectable from said piston, and wherein said second connection member comprises the other one of said complimentary male member and female member; and

,

wherein said male member comprises a bulbous end portion and said female member comprises a plurality of fingers, and wherein said plurality of fingers receive and restrainably engage said bulbous end portion therebetween when said first and second connection members are collocated within said second portion of said tubular member.

45. A system as recited in claim 44, wherein in said first piston position said plurality of fingers receive and restrainably engage said bulbous end portion therebetween.