Fluid processing systems and methods using extracorporeal fluid flow panels oriented within a cartridge

• US 6,579,253 B1
• Filed: 02/25/2000
• Issued: 06/17/2003
• Est. Priority Date: 02/14/1997
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG), Nstage Medical, Inc.
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/513,773
• Time in Patent Office: 1,208 Days
• Field of Search: 604/4.01, 604/6.01, 604/5-1-, 604/6.09, 604/6.1, 604/6.11, 604/6.16, 604/403-16, 422/44, 210/645-47, 210/650-52, 210/739, 210/741, 210/744, 210/767, 210/790, 210/805, 210/85, 210/87-90, 210/97, 210/98, 210/252-53, 210/257.1, 210/257.2, 210/258, 210/262, 210/256, 210/321.6, 210/321-1-3, 210/929, 210/416.1, 210/417-420, 210/194, 210/195--19, 222/133-34, 222/129, 222/206-7, 222/212-13, 222/544-45, 383/32, 383/37
• US Class Current: 604/5.01
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3441 Substitution rate control as a function of the ultrafiltration rate
• CPC Class Codes: A61M 1/3444 in which the collected ultra-filtrate expels an equal volume of substitution fluid from a reservoir
• CPC Class Codes: A61M 1/3448 by mechanically linked pumps in both ultra-filtrate and substitution flow line
• CPC Class Codes: A61M 1/3458 having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/3612 after treatment
• CPC Class Codes: A61M 1/362223 the interface being evacuated interfaces to enhance contact
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362262 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/35 : Communication
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/6018 : providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 39/0208 : Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes

Abstract

A first flow path is defined within a first panel that forms a part of an extracorporeal fluid circuit. A second flow path is defined within a second panel that also forms a part of the extracorporeal fluid circuit. The first and second panels are oriented in a fluid processing cartridge for mounting as an integrated unit on a fluid processing machine and for removal as an integrated unit from the fluid processing machine.

Claims

1. A fluid processing system comprising

an extracorporeal circuit for circulating a fluid from an individual through a filter to remove waste and to return fluid to the individual after removal of waste, a first portion of the extracorporeal circuit being integrated, at least in part, within a first panel, a second portion of the extracorporeal circuit being integrated, at least in part, within a second panel, and

a fluid processing cartridge orienting the first and second panels for mounting as an integrated unit on a fluid processing machine and for removal as an integrated unit from the fluid processing machine.

2. A system according to claim 1

wherein the first portion of the extracoporeal circuit handles waste fluid.

3. A system according to claim 2

wherein the second portion of the extracoporeal circuit handles replacement fluid for return to the individual.

4. A system according to claim 1

wherein at least one of the first and second panels includes an operative region that flexes in response to an external force applied by the fluid processing machine.

5. A system according to claim 4

wherein the operative region-comprises an in-line clamping region that flexes to occlude fluid flow.

6. A system according to claim 4

wherein the operative region comprises an in-line pump tube that flexes in response to peristaltic force to pump fluid.

7. A system according to claim 1

wherein the first and second portions of the extracorporeal circuit include in-line chambers that volumetrically balance waste fluid removed from the individual and waste replacement fluid returned to the individual.

8. A system according to claim 1

wherein the first and second panels are flexible and the fluid processing cartridge orients the first and second flexible panels in an overlaying relationship.

9. A system according to claim 1

wherein at least one of the first and second panels includes an operative region that permits sensing of a flow condition by a sensor on the fluid processing machine.

10. A system according to claim 1

wherein the fluid processing cartridge includes a tray containing the first and second panels.

11. A fluid processing system comprising

a fluid processing machine including a chassis and an actuator on the chassis for applying a force,

an extracorporeal circuit for circulating fluid from an individual through a filter to remove waste and to return fluid to the individual after removal of waste, a first portion of the extracorporeal circuit being integrated, at least in part, within a first panel, a second portion of the extracorporeal circuit being integrated, at least in part, within a second panel, at least one of the first and second panels includes an operative region that flexes in response to force applied by the actuator, and

a fluid processing cartridge orienting the first and second flexible panels for mounting as an integrated unit on the chassis with the operative region aligned with the actuator and for removal as an integrated unit from the chassis.

13. A system according to claim 11 or 12

wherein the first portion of the extracoporeal circuit handles waste fluid.

14. A system according to claim 13

wherein the second portion of the extracoporeal circuit handles replacement fluid for return to the individual.

15. A system according to claim 11 or 12

wherein the first and second portions of the extracorporeal circuit include in-line chambers to volumetrically balance waste fluid removed from the individual and waste replacement fluid returned to the individual.

16. A system according to claim 15

wherein the chassis includes a fixed volume cavity, and

wherein the in-line chambers occupy the fixed volume cavity when the fluid processing cartridge is mounted on the chassis, whereby the in-line chambers possess a volume defined by the fixed volume cavity.

17. A system according to claim 11 or 12

wherein the fluid processing cartridge orients the first and second flexible panels in an overlaying relationship.

18. A system according to claim 11

wherein the operative region comprises an in-line clamping region that flexes in response to application of force by the actuator to occlude fluid flow.

19. A system according to claim 11

wherein the operative region comprises an in-line pump tube that flexes in response to peristaltic force to pump fluid, and

wherein the actuator comprises a peristaltic pump element.

20. A system according to claim 11

wherein the fluid processing machine includes a sensor on the chassis, and

wherein at least one of the first and second panels includes an operative region that permits sensing of a flow condition by a sensor.

21. A system according to claim 11 or 12

wherein the fluid processing cartridge includes a tray containing the first and second panels.

12. A fluid processing system comprising

a fluid processing machine including a chassis and a sensor on the chassis,

an extracorporeal circuit for circulating fluid from an individual through a filter to remove waste and to return blood to the individual after removal of waste, a first portion of the extracorporeal circuit being integrated, at least in part, within a first panel, a second portion of the extracorporeal circuit being integrated, at least in part, within a second panel, at least one of the first and second panels includes an operative region that permits sensing of a flow condition by the sensor, and

a fluid processing cartridge orienting the first and second flexible panels for mounting as an integrated unit on the chassis with the operative region aligned with the sensor and for removal as an integrated unit from the chassis.

22. A fluid processing system comprising

an extracorporeal circuit for circulating a fluid from an individual through a filter to remove waste and to return fluid to the individual after removal of waste, a first portion of the extracorporeal circuit being defined, at least in part, by a first panel whose fluid-containing walls are defined substantially by opposing flexible sheets;

a cartridge supporting said first panel for mounting as an integrated unit, with said first panel aligned for actuation by a fluid processing machine.

23. A system as in claim 22, wherein said first and second panels are held in an overlaying relationship such that one of each of said first and second panel flexible sheets lie adjacent to the other.

24. A system as in claim 23, wherein the first and second panels define in line chambers that are held in said cartridge such that when actuated by said machine, volumetrically balance waste fluid removed from the individual and waste replacement fluid returned to the individual by means of said one of each of said first and second panel flexible sheets bearing against the other due to fluid pressure therewithin.

25. A system as in claim 22 wherein said first panel is defined entirely by opposed flexible sheets attached to form at least one of a chamber and a channel between attached portions.

26. A system as in claim 22, further comprising a second panel whose fluid-containing walls are defined substantially by further opposing flexible sheets.

27. A system according to claim 22 wherein at least one of the first and second panels includes an operative region that flexes in response to an external force applied by the fluid processing machine.

28. A system according to claim 22, wherein the first and second panels include operative regions having an in line clamping region that flexes to occlude fluid flow.

29. A blood processing system comprising

an extracoporeal fluid circuit including a first flexible panel having a pattern of seals defining a first flow path that forms a part of the extracorporeal fluid circuit, a second flexible panel having a pattern of seals defining a second flow path that forms another part of the extracorporeal fluid circuit, and a fluid processing cartridge retaining the first and second flexible panels in an overlaying relationship, and

a fluid processing device including a chassis to removably mount the fluid processing cartridge with the first flexible panel adjacent to the chassis, and a sensor on the chassis to sense a flow condition in the second flow path through the first and second flexible panels.

30. A system according to claim 29

further including a sensor on the chassis to sense a flow condition in the first flow path through the first flexible panel.

31. A system according to claim 30

wherein the sensor senses pressure in the first flow path through the first flexible panel.

32. A system according to claim 30

wherein the sensor senses air in the first flow path through the first flexible panel.

33. A system according to claim 29

wherein the fluid processing cartridge includes a tray movable into and out of association with the chassis.

34. A system according to claim 33

wherein the tray includes a cut-out exposing a region of the first flexible panel to the sensor.

35. A system according to claim 29

wherein the sensor senses pressure in the second flow path through the first and second flexible panels.

36. A system according to claim 29

wherein the sensor senses air in the second flow path through the first and second flexible panels.

37. A fluid processing system comprising

an extracorporeal circuit for circulating a fluid from an individual through a filter to remove waste and to return fluid to the individual after removal of waste, a first portion of the extracorporeal circuit being defined, at least in part, by a first panel whose fluid-containing walls are defined substantially by opposing flexible sheets;

a cartridge supporting said first and second panels for mounting as an integrated unit;

with said first and second panels aligned for actuation by a fluid processing machine such that a portion of one forming a first flow volume cooperates with a portion of the other forming a second flow volume define, together with said machine, a volumetric balancing chamber with a flexible wall between said volumes, said flexible wall being defined by adjacent flexible sheet portions of said first and second panels.

38. A system as in claim 37 wherein said first and second panels are defined entirely of opposed flexible sheets attached to form said flow volumes.

39. A blood processing system comprising

an extracoporeal fluid circuit including a first flexible panel having a pattern of seals defining a first flow path that forms a part of the extracorporeal fluid circuit, a second flexible panel having a pattern of seals defining a second flow path that forms another part of the extracorporeal fluid circuit, and a fluid processing cartridge retaining the first and second flexible panels in an overlaying relationship, and

a fluid processing device including a chassis to removably mount the fluid processing cartridge with the first flexible panel oriented adjacent to the chassis, and an actuator on the chassis operating to apply force through the first flexible panel to a region of the second flexible panel to either pump fluid in the second flow path or occlude flow in the second flow path.

40. A system according to claim 39

wherein the actuator comprises a pump element to apply a peristaltic force to the region of the second flexible panel through the first flexible panel.

41. A system according to claim 40

wherein the second flow path includes an in-line pump tube to which the peristaltic force is applied.

42. A system according to claim 39

wherein the actuator includes a clamp element to apply an occlusion force to the region of the second flexible panel through the first flexible panel.

43. A system according to claim 42

wherein the second flow path includes an in-line clamping region to which the occlusion force is applied.

44. A system according to claim 39

wherein the first flow path includes a first in-line clamping region,

wherein the second flow path includes a second in-line clamping region

wherein the fluid processing cartridge retains the first in-line clamping region and second in-line clamping region in an overlaying relationship, and

wherein the actuator includes a clamp element that applies an occlusion force simultaneously to the overlaying first and second in-line clamping regions.

45. A system according to claim 39

further including a sensor on the chassis to sense a flow condition in the second flow path through the first and second flexible panels.

46. A system according to claim 45

wherein the sensor senses pressure in the second flow path through the first and second flexible panels.

47. A system according to claim 45

wherein the sensor senses air in the second flow path through the first and second flexible panels.

48. A system according to claim 39

further including an actuator on the chassis operating to apply force through a region of the first flexible panel to either pump fluid in the first flow path or occlude flow in the first flow path.

49. A system according to claim 39

wherein the fluid processing cartridge includes a tray movable into and out of association with the chassis.

50. A system according to claim 49

wherein the tray includes a cut-out exposing a region of the first flexible panel to the actuator.

51. A fluid processing method comprising the steps of

establishing an extracoporeal fluid circuit that communicates with filter,

defining within a first panel a first flow path that forms a part of the extracorporeal fluid circuit,

defining within a second panel a second flow path that forms another part of the extracorporeal fluid circuit, and

orienting the first and second panels in a fluid processing cartridge for mounting as an integrated unit on a fluid processing machine and for removal as an integrated unit from the fluid processing machine.

52. A method according to claim 51

wherein the orienting step places the first and second panels in an overlaying relationship.