Portable dialysis machine

• US 9,517,296 B2
• Filed: 09/27/2013
• Issued: 12/13/2016
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Fulkerson, Barry Neil, Braig, James Roswell, Mishelevich, David J, Clemens, Charles, Foster, Clark Berg, Hering, Martin, Zwierstra, Jan Brian, Joseph, Russell Thomas, Gura, Victor, Robinson, Thomas, Trcka, Milan, Ghidoli, Daniele, Isackson, Frank, Smith, Mark Forrest
• Primary Examiner(s): DRODGE, JOSEPH W
• Application Number:
  US14/040,362
• Publication Number:
  US 20140138294A1
• Time in Patent Office: 1,173 Days
• Field of Search: 210/86, 210/96.2, 210/149, 210/175, 210/184, 210/321.6, 210/321.71, 210/321.72, 210/646, 210/647, 210/87, 210/90, 210/91, 210/94, 210/138, 210/141, 210/143, 210/134, 210/416.1, 210/418, 604/4.01, 604/5.01, 604 601- 611, 604/29, 604 65- 67, 738/611.8, 738/612.7, 251/65, 345/30, 345/33, 345/619, 417/2, 417/477.1, 417/477.2, 600/483, 600/500
• US Class Current: 1/1
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1643 with weighing of fresh and used dialysis fluid
• CPC Class Codes: A61M 1/1645 with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/3413 Diafiltration
• 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 1/3641 Pressure isolators
• CPC Class Codes: A61M 1/3646 Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3656 Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/3672 Means preventing coagulation
• CPC Class Codes: A61M 1/369 Temperature treatment
• CPC Class Codes: A61M 2205/10 with powered movement mechanisms
• CPC Class Codes: A61M 2205/126 with incorporated membrane filters
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3393 : by weighing the reservoir
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/584 : having a color code
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2209/084 : Supporting bases, stands for equipment
• CPC Class Codes: B01D 2313/10 : Specific supply elements
• CPC Class Codes: B01D 2313/105 : Supply manifolds
• CPC Class Codes: B01D 2313/12 : Specific discharge elements
• CPC Class Codes: B01D 2313/125 : Discharge manifolds
• CPC Class Codes: B01D 2313/243 : Pumps
• CPC Class Codes: B01D 61/18 : Apparatus therefor
• CPC Class Codes: B01D 61/30 : Accessories; Auxiliary operation
• CPC Class Codes: B01D 61/32 : Controlling or regulating

Abstract

The specification discloses a portable dialysis machine having a detachable controller unit and base unit. The controller unit includes a door having an interior face, a housing with a panel, where the housing and panel define a recessed region configured to receive the interior face of the door, and a manifold receiver fixedly attached to the panel. The base unit has a planar surface for receiving a container of fluid, a scale integrated with the planar surface, a heater in thermal communication with the planar surface, and a sodium sensor in electromagnetic communication with the planar surface. Embodiments of the disclosed portable dialysis system have improved structural and functional features, including improved modularity, ease of use, and safety features.

Claims

1. A dialysis machine for processing blood, comprising:

a controller unit comprising

a housing defining an interior volume,

a door for accessing said interior volume,

a manifold receiver positioned within said interior volume configured to receive a disposable manifold, and

a processing unit for controlling a flow of blood through the disposable manifold received by the manifold receiver; and

a reservoir unit that is physically separate from said controller unit and is in data communication with said controller unit, wherein said reservoir unit comprises

a planar surface for receiving a container of fluid,

a first scale in physical communication with said planar surface and configured to weigh said container of fluid disposed on the planar surface, and

a heater configured to be in thermal communication with said container of fluid disposed on the planar surface.

2. The dialysis machine of claim 1, further comprising said disposable manifold.

3. The dialysis machine of claim 2, further comprising a dialyzer and tubing, the tubing being attached to, and forming a fluid communication between, the disposable manifold and the dialyzer.

4. The dialysis machine of claim 2, wherein the controller unit comprises a plurality of sensors configured to be in communication with the disposable manifold when an interior face of the door is in said interior volume.

5. The dialysis machine of claim 4, wherein at least one said plurality of sensors comprises a pressure transducer and wherein the pressure transducer is in pressure communication with a flexible membrane integrated into said disposable manifold when the interior face of the door is in said interior volume.

6. The dialysis machine of claim 4, wherein at least one said plurality of sensors comprises a temperature sensor configured to be in thermal communication with the disposable manifold when the interior face of the door is in said interior volume.

7. The dialysis machine of claim 1, further comprising said container of fluid.

8. The dialysis machine of claim 7, further comprising said disposable manifold, wherein the disposable manifold is received in the manifold receiver, and tubing, wherein the tubing is attached to, and forms a fluid communication between, the disposable manifold and the container of fluid.

9. The dialysis machine of claim 1, wherein the housing further comprises a panel, the housing and panel defining a portion of the interior volume that receives said door, and wherein said panel is configured to provide access to a plurality of peristaltic pumps.

10. The dialysis machine of claim 9, wherein an interior face of said door comprises a plurality of pump shoes and wherein, when said door is received into said portion of the interior volume, each of said plurality of pump shoes aligns with each of said plurality of peristaltic pumps.

11. The dialysis machine of claim 1, wherein said controller unit further comprises a structure connected to an exterior of said housing and wherein said structure is configured to physically receive said dialyzer.

12. The dialysis machine of claim 1, wherein the scale comprises a plurality of flexures and hall sensors, wherein each of said flexures is in physical communication with said planar surface and wherein each of said hall sensors is configured to sense a physical displacement.

13. The dialysis machine of claim 1, wherein the controller unit comprises a disconnection monitor for determining if a blood line connection to a patient has been disconnected.

14. The dialysis system of claim 1, wherein said controller unit further comprises:

a display;

an electronic reader; and

,

a memory storing a plurality of programmatic instructions, wherein, upon execution, said instructions generate;

a first graphical user interface for presentation on said display, wherein said first graphical user interface displays a plurality of additives required for use in a dialysis treatment; and

a second graphical user interface for presentation on said display, wherein said second graphical user interface prompts a user of said system to submit a plurality of additives to scanning using said electronic reader.

15. The dialysis system of claim 1, further comprising said disposable manifold wherein said disposable manifold comprises a first flow path and a second flow path defined therein and wherein said first flow path and said second flow path are fluidically separated by a valve.

16. The dialysis system of claim 15, wherein said controller unit further comprises a memory storing a plurality of programmatic instructions, wherein said programmatic instructions are configured to define a first state of said valve and a second state of said valve depending upon whether a priming mode or a treatment mode is selected.

17. The dialysis system of claim 15, wherein said disposable manifold comprises a first fluid circuit for infusing fluid into a patient and a second fluid circuit for removing fluid from the patient, wherein said controller unit further comprises a first pump and a second pump, and wherein said controller unit is configured to cause said first pump to alternatively operate on said first circuit and said second circuit and to cause said second pump to alternatively operate on said first circuit and said second circuit, wherein each of the said first pump and second pump operate on only one circuit at a given time.

18. The dialysis system of claim 1 wherein the door comprises an interior face with a pressure plate.

19. The dialysis system of claim 18 wherein the housing comprises a panel, wherein said housing and panel define a recessed region configured to receive the interior face of said door, and wherein the panel further comprises an alignment mechanism configured to detachably receive said disposable manifold and position said disposable manifold against said pressure plate when the door is received into said housing.

20. A dialysis machine for processing blood, comprising:

a controller unit comprising

a housing defining an interior volume,

a panel positioned in said housing and configured to provide access to a plurality of pumps;

a door for accessing said interior volume, wherein said door comprises an interior face with a plurality of pump shoes;

a manifold receiver positioned on said panel and configured to receive a disposable manifold, and

a processing unit for controlling a flow of blood through the disposable manifold received by the manifold receiver; and

a reservoir unit that is physically separate from said controller unit and is in data communication with said controller unit, wherein said reservoir unit comprises

a planar surface for receiving a container of fluid,

a first scale in physical communication with said planar surface and configured to weigh the container of fluid disposed on the planar surface, and

a heater configured to be in thermal communication with the container of fluid disposed on the planar surface.