Layered fluid circuit assemblies and methods for making them

• US 6,554,789 B1
• Filed: 02/25/2000
• Issued: 04/29/2003
• Est. Priority Date: 02/14/1997
• Status: Expired due to Term

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG), Mstage Medical Inc.
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Thomas, Robert, Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): Bianco, Patricia
• Application Number:
  US09/513,902
• Time in Patent Office: 1,159 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, 604/403-416, 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, 210/253, 210/256, 210/257--25, 210/258-262, 210/321.6, 210/321-1-3, 210/929, 210/416.1, 210/417-420, 210/194, 210/195--19, 383/32, 383/37, 222/129, 222/133-34, 222/206-207, 222/212-13, 222/544-45
• US Class Current: 604/6.11
• 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 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 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 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• 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 2205/502 : User interfaces, e.g. screens or keyboards
• 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 39/0208 : Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

A layered fluid circuit includes first and second panel sections formed from sealed sheets of flexible material. A pattern of seals is formed in the first panel section to define a first fluid circuit. A pattern of seals is formed in the second panel section to define a second fluid circuit. The flexible sheets are aligned to place the first and second panel sections in a relationship with the first fluid circuit overlaying the second fluid circuit. The layered fluid circuit can be placed in a tray for use. Defined operating regions can be formed in one or both fluid circuits, such as an in-line clamping regions, in-line pump tubes, or in-line sensor regions, or in-line fluid holding compartments, or combinations thereof.

Claims

1. A fluid circuit assembly comprising flexible sheets sealed to form first and second panel sections, a pattern of seals formed in the first panel section to define a first fluid circuit, and a pattern of seals formed in the second panel section to define a second fluid circuit, the flexible sheets mutually aligned to place the first and second panel sections in a relationship with the first fluid circuit overlaying the second fluid circuit.

3. An assembly according to claim 1 or 2 wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line clamping region that closes in response to an exterior force to occlude fluid flow in the first fluid circuit.

4. An assembly according to claim 1 or 2 wherein the first fluid circuit includes a first in-line clamping region that closes in response to an exterior force to occlude fluid flow in the first fluid circuit, wherein the second fluid circuit includes a second in-line clamping region that closes in response to an exterior force to occlude fluid flow in the second fluid circuit, and wherein the first in-line clamping region overlays the second in-line clamping region so that the first and second in-line clamping regions jointly close in response to an exterior force to occlude fluid flow in both the first and second fluid circuits.

5. An assembly according to claim 1 or 2 wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line pump tube.

6. An assembly according to claim 1 or 2 wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line sensor region to transmit pressure to an exterior pressure sensor.

7. An assembly according to claim 1 or 2 wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line fluid holding compartment.

8. An assembly according to claim 1 or 2 wherein the first fluid circuit includes a first in-line fluid holding compartment, wherein the second fluid circuit includes a second in-line fluid holding compartment, and wherein the first in-line fluid holding compartment overlays the second in-line fluid holding compartment to mutually form a two-compartment chamber.

9. An assembly according to claim 1 or 2 further including at least one length of flexible tubing extending from a panel section and joined in fluid communication with the first fluid circuit or the second fluid circuit.

2. A fluid circuit assembly comprising first and second sheets of flexible material sealed to form first and second panel sections, a pattern of seals formed in the first panel section to define a first fluid circuit, and a pattern of seals formed in the second panel section to define a second fluid circuit, the flexible sheets being folded over to place the first and second panel sections in a reverse facing relationship with the first fluid circuit overlaying the second fluid circuit.

10. A fluid processing module comprising

a tray including walls defining an interior space, and

a fluid circuit assembly carried within the interior space comprising flexible material sealed to form first and second panels, a pattern of seals formed in the first panel to define a first fluid circuit, and a pattern of seals formed in the second panel to define a second fluid circuit, the flexible sheets being aligned within the interior space to place the first and second panels in a relationship with the first fluid circuit overlaying the second fluid circuit.

12. A module according to claim 10 or 11

wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line clamping region that closes in response to an exterior force to occlude fluid flow in the first fluid circuit, and

wherein a tray wall includes a cut-out to expose the in-line clamping region.

13. A module according to claim 10 or 11

wherein the first fluid circuit includes a first in-line clamping region that closes in response to an exterior force to occlude fluid flow in the first fluid circuit,

wherein the second fluid circuit includes a second in-line clamping region that closes in response to an exterior force to occlude fluid flow in the second fluid circuit,

wherein the first in-line clamping region overlays the second in-line clamping region so that the first and second in-line clamping regions jointly close in response to an exterior force to occlude fluid flow in both the first and second fluid circuits, and

wherein a tray wall includes a cut-out to expose the overlaying first and second in-line clamping regions.

14. A module according to claim 10 or 11

wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line pump tube, and

wherein a tray wall includes a cut-out to expose the in-line pump tube.

15. A module according to claim 10 or 11

wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line sensor region to transmit pressure to an exterior pressure sensor, and

wherein a tray wall includes a cut-out to expose the in-line sensor region.

16. A module according to claim 10 or 11

wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line fluid holding compartment, and

wherein a tray wall includes a cut-out to expose the in-line fluid holding compartment.

17. A module according to claim 10 or 11

wherein the first fluid circuit includes a first in-line fluid holding compartment,

wherein the second fluid circuit includes a second in-line fluid holding compartment,

wherein the first in-line fluid holding compartment overlays the second in-line fluid holding compartment to mutually form a two-compartment chamber, and

wherein the tray includes a cut-out to expose the two-compartment chamber.

18. A module according to claim 10 or 11

further including at least one length of flexible tubing held in the interior space and joined in fluid communication with either the first fluid circuit or the second fluid circuit.

11. A fluid processing module comprising

a tray including walls defining an interior space, and

a fluid circuit assembly carried within the interior space comprising first and second sheets of flexible material sealed to form first and second panels, a pattern of seals formed in the first panel to define a first fluid circuit, and a pattern of seals formed in the second panel to define a second fluid circuit, the flexible sheets being folded over to place the first and second panels in a reverse facing relationship within the interior space, with the first fluid circuit overlaying the second fluid circuit.

19. A fluid circuit for volumetrically balancing fluid comprising first and second sheets of flexible material sealed to form first and second panels, a pattern of seals formed in the first panel to define a first fluid circuit for handling out going fluid and including a first in-line compartment to retain a volume of out going fluid, and a pattern of seals formed in the second panel to define a second fluid circuit for handing in going fluid and including a second in-line compartment to retain a volume of in going fluid, the flexible sheets being aligned to place the first and second panels in a relationship with the first in-line compartment overlaying the second in-line compartment to mutually form a two-compartment chamber that displaces out going fluid from the first in-line compartment as in going fluid is conveyed into the second in-line compartment, and vice versa.

20. A fluid circuit according to claim 19

wherein the second fluid circuit includes a second in-line clamping region communicating with the second in-line compartment, the second in-line clamping region closing in response to an exterior force to occlude fluid flow.

21. A fluid circuit according to claim 20

wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line pump tube.

22. A fluid circuit according to claim 20

wherein at least one of the first fluid circuit and the second fluid circuit includes an in-line sensor region to transmit pressure to an exterior pressure sensor.

23. A fluid circuit according to claim 19

wherein the first fluid circuit includes a first in-line clamping region communicating with the first in-line compartment, the first in-line clamping region closing in response to an exterior force to occlude fluid flow.

24. A fluid circuit according to claim 20

wherein the first fluid circuit includes a first in-line clamping region communicating with the first in-line compartment, the first in-line clamping region closing in response to an exterior force to occlude fluid flow,

wherein the first in-line clamping region overlays the second in-line clamping region so that the first and second in-line clamping regions jointly close in response to an exterior force to occlude fluid flow.

25. A flow management system, comprising:

first and second sheets of material sealed to form first and second panels, the first panel having a first fluid pathway for handling a first fluid comprising a first compartment to receive a volume of the first fluid, the second panel having a second fluid pathway for handling a second fluid comprising a second compartment to receive a volume of the second fluid,

the panels being aligned so that the first compartment overlays the second compartment to form a structure so that the first fluid from the first compartment is displaced as the second fluid fills the second compartment.

26. The flow management system of claim 25, wherein the panels are aligned by folding.

27. The flow management system of claim 25, wherein the panels are die cut and overlay one another.

28. The flow management system of claim 25, wherein the sheets are flexible.

29. The flow management system of claim 25, wherein each panel has a pattern of seals.

30. The flow management system of claim 25, wherein the first fluid is an outgoing fluid.

31. The flow management system of claim 25, wherein the second fluid is an in-going fluid.

32. A flow management system, comprising

a first panel having a first fluid pathway for handling a first fluid, the first panel comprising a first compartment to receive a volume of the first fluid and a second compartment to receive a volume of the first fluid;

and

a second panel having a second fluid pathway for handling a second fluid, the second panel comprising a third compartment to receive a volume of the second fluid and a fourth compartment to receive a volume of the second fluid,

the panels being aligned so that the first compartment overlays the third compartment to form a structure so that the first fluid from the first compartment is displaced as the second fluid fills the third compartment, and the second compartment overlays the fourth compartment to form a structure so that the second fluid from the fourth compartment is displaced as the first fluid fills the second compartment.

33. The flow management system of claim 32, wherein the panels are aligned by folding.

34. The flow management system of claim 32, wherein the panels are die cut and overlay one another.

35. The flow management system of claim 32, wherein the panels are flexible.

36. The flow management system of claim 32, wherein each panel has a pattern of seals.

37. The flow management system of claim 32, wherein the first fluid is an outgoing fluid.

38. The flow management system of claim 32, wherein the second fluid is an in-going fluid.

39. A fluid circuit assembly comprising:

flexible sheets each arranged parallel and sealed to at least another to form first and second panels;

a pattern of seals formed in the first panel section to define a first fluid circuit;

a pattern of seals formed in the second panel section to define a second fluid circuit;

the first and second panels mutually alignable to place the first and second panels in such a relationship that the first fluid circuit overlies the second fluid circuit.

40. A fluid circuit assembly comprising:

flexible sheets sealed to form first and second panel sections;

a pattern of seals formed in the first panel section to define a first fluid circuit portion;

a pattern of seals formed in the second panel section to define a second fluid circuit portion;

the panel sections being aligned to place at least part of the first and second fluid circuit portions in an overlying relationship such that two layers of said sheets separate said parts of said first and second fluid circuit portions, each layer corresponding to a respective one of said first and second fluid circuits, whereby a force of an actuator may be applied through said two layers.

41. A fluid circuit for volumetrically balancing fluid comprising first and second sheets of flexible material sealed to form first and second panels, a pattern of seals formed in the first panel to define a first fluid circuit for handling out going fluid and including a first in-line compartment to retain a volume of out going fluid, and a pattern of seals formed in the second panel to define a second fluid circuit for handing in going fluid and including a second in-line compartment to retain a volume of in going fluid, the flexible sheets being aligned to place the first and second panels in a relationship with the first in-line compartment overlaying the second in-line compartment to mutually form a two-compartment chamber, such that the first and second in-line compartments are divided by two layers formed by said sheets, each corresponding to a respective one of said first and second in-line compartments, the two-compartment chamber displaces out going fluid from the first in-line compartment as in going fluid is conveyed into the second in-line compartment, and vice versa.