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Patent · US11045596B2 · B2 · US

Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation using water accumulator and disposable set

(11) Publication number
US11045596B2
(21) Application number
15/588,235
(22) Filing date
2017-05-05
(30) Priority date
2016-05-06
(43) Publication date
2021-06-29
(45) Date of grant
2021-06-29
(51) IPC
A61M 1/28; C02F 1/00; C02F 1/44; A61M 1/16
(52) CPC
  • A61M Devices for introducing media into, or onto, the body; devices for transducing body media or for taking media from the body; devices for producing or ending sleep or stupor {}: 1/1656, 1/1524, 1/155, 1/1561, 1/1565, 1/159, 1/1605, 1/166, 1/1666, 1/28, 1/281, 1/282, 1/284, 1/287, 2205/12, 2205/18, 2205/276, 2205/3317, 2205/3331, 2205/3337, 2205/3368, 2205/3569, 2205/36, 2205/3653, 2205/50, 2205/502, 2205/6054, 2205/6072, 2205/702, 2205/705, 2205/75, 2205/7518, 5/152
  • C02F Treatment of water, waste water, sewage, or sludge: 1/008, 1/02, 1/441, 1/444, 2103/026, 2209/03, 2209/40, 9/00
(73) Assignee
Gambro Lundia AB
(72) Inventors
Edward S. Szpara; Olof Ekdahl; Olof Jansson
(54) Title
Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation using water accumulator and disposable set
(57) Abstract

A peritoneal dialysis system includes a water purifier, a cycler, and a disposable set operable with the cycler. The disposable set includes a pumping cassette including a water inlet port, a heater/mixing container in fluid communication with the pumping cassette, a water accumulator, a first water line segment, and a second water line segment. The first water line segment is in fluid communication with the water inlet port and the water accumulator. Additionally, the second water line segment is in fluid communication with the water accumulator and the water purifier.

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Claims (18)

  1. A peritoneal dialysis system comprising: a water purifier; a cycler; and a disposable set operable with the cycler, the disposable set including a pumping cassette including a water inlet port, a container in fluid communication with the pumping cassette, a water accumulator configured to isolate operation of the water purifier from operation of the disposable set with the cycler, wherein the water purifier is configured to pump water purified by the water purifier towards the water accumulator, a first water line segment in fluid communication with the water inlet port and the water accumulator, a second water line segment in fluid communication with the water accumulator and the water purifier, and a drain line having a proximal end and a distal end, wherein the proximal end is attached to the pumping cassette, and wherein the distal end of the drain line is configured to be connected to an end of the second water line segment connected to the water purifier when the disposable set is removed from the water purifier.
  2. The peritoneal dialysis system of claim 1, wherein the second water line segment is provided with at least one sterile sterilizing grade filter.
  3. The peritoneal dialysis system of claim 2, wherein the water purifier is configured to enter an alarm state upon sensing a change in operating pressure due to failure of the at least one sterile sterilizing grade filter, and wherein the water accumulator is positioned and arranged to absorb the change in operating pressure.
  4. The peritoneal dialysis system of claim 3, wherein the alarm state includes a notification from the water purifier to the cycler.
  5. The peritoneal dialysis system of claim 1, wherein the water purifier includes an ultrafilter and the disposable set includes a sterile sterilizing grade filter.
  6. The peritoneal dialysis system of claim 1, wherein the water purifier includes a plurality of ultrafilters.
  7. The peritoneal dialysis system of claim 1, wherein the first water line segment is in fluid communication with an outlet of the water accumulator and the second water line segment is in fluid communication with an inlet of the water accumulator.
  8. The peritoneal dialysis system of claim 1, wherein the container and the water accumulator are provided as different chambers of a multi-chamber bag.
  9. The peritoneal dialysis system of claim 1, wherein the distal end of the drain line is configured to be connected to a connector located at the water purifier.
  10. The peritoneal dialysis system of claim 1, wherein the water accumulator, the water purifier and the cycler are in fluid communication such that the water accumulator is simultaneously and communicatively coupled to both the water purifier and the disposable set with the cycler.
  11. The peritoneal dialysis system of claim 1, wherein the distal end of the drain line includes a corresponding drain line connector, and wherein the end of the second water line segment includes a corresponding water line connector, and wherein one of the drain line connector and the water line connector is a male connector while the other is a female connector.
  12. A peritoneal dialysis system comprising: a water purifier; a cycler including a pump actuator; a disposable set operable with the cycler, the disposable set including a pumping cassette including a pump chamber placeable in operable communication with the pump actuator, a container in fluid communication with the pumping cassette, and a water accumulator in fluid communication with the pumping cassette and the water purifier, the water accumulator configured to isolate operation of the water purifier from operation of the disposable set with the cycler, a water line segment in fluid communication with the water accumulator and the water purifier, a drain line having a proximal end and a distal end, wherein the proximal end is attached to the pumping cassette, and wherein the distal end of the drain line is configured to be connected to an end of the water line segmented connected to the water purifier when the disposable set is removed from the water purifier, and which is configured to cause the water purifier to pump water purified by the water purifier towards the water accumulator while (i) the pump actuator is actuating the pump chamber to pump fresh dialysis fluid from the container during a fill phase, (ii) treatment is in a dwell phase, or (iii) the pump actuator is actuating the pump chamber to pump used dialysis fluid from the pumping cassette during a drain phase.
  13. The peritoneal dialysis system of claim 12, wherein the water purifier includes a water purifier control unit and the cycler includes a cycler control unit, and wherein the cycler control unit is configured to command the water purifier control unit to cause the water purifier to pump water purified by the water purifier towards the water accumulator during (i), (ii) or (iii).
  14. The peritoneal dialysis system of claim 13, wherein the cycler control unit is configured to control (i), (ii) and (iii).
  15. The peritoneal dialysis system of claim 12, wherein the cycler is configured to cause the pump actuator to actuate the pump chamber to mix water purified by the water purifier with at least one concentrate while treatment is in the dwell phase.
  16. The peritoneal dialysis system of claim 12, wherein the cycler is configured to cause the pump actuator to actuate the pump chamber to pull water purified by the water purifier from the water accumulator into the pump chamber while treatment is in the dwell phase.
  17. The peritoneal dialysis system of claim 12, wherein the cycler is configured to cause the pump actuator to actuate the pump chamber to push water purified by the water purifier to the container while treatment is in the dwell phase.
  18. The peritoneal dialysis system of claim 12, wherein the water accumulator, the water purifier and the cycler are in fluid communication such that the water accumulator is simultaneously and communicatively coupled to both the water purifier and the disposable set with the cycler.

Description

This application claims priority to and the benefit of U.S. Provisional Application Ser. No. 62/332,617, entitled, “Apparatus for Proportioning Fluids II”, filed May 6, 2016; U.S. Provisional Application Ser. No. 62/332,623, entitled, “Apparatus for Proportioning Fluids II”, filed May 6, 2016; and U.S. Provisional Application Ser. No. 62/332,630, entitled, “Apparatus for Proportioning Fluids III”, filed May 6, 2016, the entire contents of each of which are incorporated herein by reference and relied upon.

The present invention relates to the field of fluid compounding for preparing fluids particularly for the treatment of renal insufficiency. More specifically, it relates to an apparatus for the treatment of renal insufficiency configured for compounding finished fluids from two or more constituent fluids for use as a kidney dialyzing fluid.

In particular, the invention may be used for preparing fluids for peritoneal dialysis, particularly for preparing fluids on-site (e.g. at patient's home).

The kidneys fulfil many functions, including the removal of water, the excretion of catabolites (or waste from the metabolism, for example urea and creatinine), the regulation of the concentration of the electrolytes in the blood (e.g. sodium, potassium, magnesium, calcium, bicarbonate, phosphate, chloride) and the regulation of the acid/base equilibrium within the body, which is obtained in particular by the removal of weak acids (phosphates, monosodium acids) and by the production of ammonium salts.

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Record as JSON
{
  "publication_number": "US11045596B2",
  "country": "US",
  "kind": "B2",
  "title": "Systems and methods for peritoneal dialysis having point of use dialysis fluid preparation using water accumulator and disposable set",
  "abstract": "A peritoneal dialysis system includes a water purifier, a cycler, and a disposable set operable with the cycler. The disposable set includes a pumping cassette including a water inlet port, a heater/mixing container in fluid communication with the pumping cassette, a water accumulator, a first water line segment, and a second water line segment. The first water line segment is in fluid communication with the water inlet port and the water accumulator. Additionally, the second water line segment is in fluid communication with the water accumulator and the water purifier.",
  "claims": [
    "1. A peritoneal dialysis system comprising: a water purifier; a cycler; and a disposable set operable with the cycler, the disposable set including a pumping cassette including a water inlet port, a container in fluid communication with the pumping cassette, a water accumulator configured to isolate operation of the water purifier from operation of the disposable set with the cycler, wherein the water purifier is configured to pump water purified by the water purifier towards the water accumulator, a first water line segment in fluid communication with the water inlet port and the water accumulator, a second water line segment in fluid communication with the water accumulator and the water purifier, and a drain line having a proximal end and a distal end, wherein the proximal end is attached to the pumping cassette, and wherein the distal end of the drain line is configured to be connected to an end of the second water line segment connected to the water purifier when the disposable set is removed from the water purifier.",
    "2. The peritoneal dialysis system of claim 1, wherein the second water line segment is provided with at least one sterile sterilizing grade filter.",
    "3. The peritoneal dialysis system of claim 2, wherein the water purifier is configured to enter an alarm state upon sensing a change in operating pressure due to failure of the at least one sterile sterilizing grade filter, and wherein the water accumulator is positioned and arranged to absorb the change in operating pressure.",
    "4. The peritoneal dialysis system of claim 3, wherein the alarm state includes a notification from the water purifier to the cycler.",
    "5. The peritoneal dialysis system of claim 1, wherein the water purifier includes an ultrafilter and the disposable set includes a sterile sterilizing grade filter.",
    "6. The peritoneal dialysis system of claim 1, wherein the water purifier includes a plurality of ultrafilters.",
    "7. The peritoneal dialysis system of claim 1, wherein the first water line segment is in fluid communication with an outlet of the water accumulator and the second water line segment is in fluid communication with an inlet of the water accumulator.",
    "8. The peritoneal dialysis system of claim 1, wherein the container and the water accumulator are provided as different chambers of a multi-chamber bag.",
    "9. The peritoneal dialysis system of claim 1, wherein the distal end of the drain line is configured to be connected to a connector located at the water purifier.",
    "10. The peritoneal dialysis system of claim 1, wherein the water accumulator, the water purifier and the cycler are in fluid communication such that the water accumulator is simultaneously and communicatively coupled to both the water purifier and the disposable set with the cycler.",
    "11. The peritoneal dialysis system of claim 1, wherein the distal end of the drain line includes a corresponding drain line connector, and wherein the end of the second water line segment includes a corresponding water line connector, and wherein one of the drain line connector and the water line connector is a male connector while the other is a female connector.",
    "12. A peritoneal dialysis system comprising: a water purifier; a cycler including a pump actuator; a disposable set operable with the cycler, the disposable set including a pumping cassette including a pump chamber placeable in operable communication with the pump actuator, a container in fluid communication with the pumping cassette, and a water accumulator in fluid communication with the pumping cassette and the water purifier, the water accumulator configured to isolate operation of the water purifier from operation of the disposable set with the cycler, a water line segment in fluid communication with the water accumulator and the water purifier, a drain line having a proximal end and a distal end, wherein the proximal end is attached to the pumping cassette, and wherein the distal end of the drain line is configured to be connected to an end of the water line segmented connected to the water purifier when the disposable set is removed from the water purifier, and which is configured to cause the water purifier to pump water purified by the water purifier towards the water accumulator while (i) the pump actuator is actuating the pump chamber to pump fresh dialysis fluid from the container during a fill phase, (ii) treatment is in a dwell phase, or (iii) the pump actuator is actuating the pump chamber to pump used dialysis fluid from the pumping cassette during a drain phase.",
    "13. The peritoneal dialysis system of claim 12, wherein the water purifier includes a water purifier control unit and the cycler includes a cycler control unit, and wherein the cycler control unit is configured to command the water purifier control unit to cause the water purifier to pump water purified by the water purifier towards the water accumulator during (i), (ii) or (iii).",
    "14. The peritoneal dialysis system of claim 13, wherein the cycler control unit is configured to control (i), (ii) and (iii).",
    "15. The peritoneal dialysis system of claim 12, wherein the cycler is configured to cause the pump actuator to actuate the pump chamber to mix water purified by the water purifier with at least one concentrate while treatment is in the dwell phase.",
    "16. The peritoneal dialysis system of claim 12, wherein the cycler is configured to cause the pump actuator to actuate the pump chamber to pull water purified by the water purifier from the water accumulator into the pump chamber while treatment is in the dwell phase.",
    "17. The peritoneal dialysis system of claim 12, wherein the cycler is configured to cause the pump actuator to actuate the pump chamber to push water purified by the water purifier to the container while treatment is in the dwell phase.",
    "18. The peritoneal dialysis system of claim 12, wherein the water accumulator, the water purifier and the cycler are in fluid communication such that the water accumulator is simultaneously and communicatively coupled to both the water purifier and the disposable set with the cycler."
  ],
  "description_excerpt": "This application claims priority to and the benefit of U.S. Provisional Application Ser. No. 62/332,617, entitled, “Apparatus for Proportioning Fluids II”, filed May 6, 2016; U.S. Provisional Application Ser. No. 62/332,623, entitled, “Apparatus for Proportioning Fluids II”, filed May 6, 2016; and U.S. Provisional Application Ser. No. 62/332,630, entitled, “Apparatus for Proportioning Fluids III”, filed May 6, 2016, the entire contents of each of which are incorporated herein by reference and relied upon.\n\nThe present invention relates to the field of fluid compounding for preparing fluids particularly for the treatment of renal insufficiency. More specifically, it relates to an apparatus for the treatment of renal insufficiency configured for compounding finished fluids from two or more constituent fluids for use as a kidney dialyzing fluid.\n\nIn particular, the invention may be used for preparing fluids for peritoneal dialysis, particularly for preparing fluids on-site (e.g. at patient's home).\n\nThe kidneys fulfil many functions, including the removal of water, the excretion of catabolites (or waste from the metabolism, for example urea and creatinine), the regulation of the concentration of the electrolytes in the blood (e.g. sodium, potassium, magnesium, calcium, bicarbonate, phosphate, chloride) and the regulation of the acid/base equilibrium within the body, which is obtained in particular by the removal of weak acids (phosphates, monosodium acids) and by the production of ammonium salts.",
  "cpc": [
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    "A61M 2205/50",
    "A61M 2205/502",
    "A61M 2205/6054",
    "A61M 2205/6072",
    "A61M 2205/702",
    "A61M 2205/705",
    "A61M 2205/75",
    "A61M 2205/7518",
    "A61M 5/152",
    "C02F 1/008",
    "C02F 1/02",
    "C02F 1/441",
    "C02F 1/444",
    "C02F 2103/026",
    "C02F 2209/03",
    "C02F 2209/40",
    "C02F 9/00"
  ],
  "ipc": [
    "A61M 1/28",
    "C02F 1/00",
    "C02F 1/44",
    "A61M 1/16"
  ],
  "assignees": [
    "Gambro Lundia AB"
  ],
  "inventors": [
    "Edward S. Szpara",
    "Olof Ekdahl",
    "Olof Jansson"
  ],
  "filing_date": "2017-05-05",
  "publication_date": "2021-06-29",
  "grant_date": "2021-06-29",
  "priority_date": "2016-05-06",
  "application_number": "US-201715588235-A",
  "family_id": "58709645",
  "cited_by_count": 10,
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}

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