# US 9,433,719 B2 · Method for optimizing tidal therapies employing ultrafiltrate trending

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- Number: US 9,433,719 B2
- Document ID: US9433719B2
- Status: Granted
- Kind: B2
- Application number: 13/402,355
- Filed: 2012-02-22
- Published: 2012-06-14
- Granted: 2016-09-06
- Earliest claimed: 2009-01-29
- Assignees: Baxter International Inc.; Baxter Healthcare S.A.
- Applicants: Robert W. Childers; Peter A. Hopping
- Inventors: Robert W. Childers; Peter A. Hopping
- Web page: https://patentgrep.com/patent/US9433719B2

## CPC

- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/1524: {the interface providing means for actuating on functional elements of the cassette, e.g. plungers}
- A61M 1/155: {with treatment-fluid pumping means or components thereof}
- A61M 1/1561: {at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil}
- A61M 1/159: {specially adapted for peritoneal dialysis}
- A61M 1/1603: {Regulation parameters}
- A61M 1/282: {Operational modes}
- B01D 61/32: Controlling or regulating
- A61M 1/1565: {Details of valves}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/3553: remote, e.g. between patient's home and doctor's office
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)

## Abstract

A system and method for automatically adjusting a Continuous Cycling Peritoneal Dialysis (“CCPD”) therapy to minimize the potential for excess intra-peritoneal volume. The adjustments are made at the end of the drain, just prior to the next fill. The adjustments short the next fill, if necessary, to limit the intra-peritoneal volume, add a cycle, if necessary, to use all of the available dialysis solution and will average the remaining dwell time to maximize the therapeutic benefit of the therapy in the allotted time. In another embodiment, a tidal therapy using trended patient UF data is provided.

## Claims

### Claim 1

An automated peritoneal dialysis method comprising:
(i) pumping dialysis fluid to a patient during a fill phase;
(ii) allowing the dialysis fluid to dwell within the patient during a dwell phase;
(iii) pumping effluent dialysis fluid from the patient during a patient drain phase;
(iv) determining a trended ultrafiltration (“UF”) data point corresponding to an amount of UF removed from the patient during the patient drain phase;
(v) repeating (i) to (iv) at least once;
(vi) operating a processor to determine an amount of the effluent dialysis fluid to remove from the patient during at least one subsequent patient drain phase based on at least two trended UF data points for the patient; and
(vii) repeating (i) to (iii) at least one additional time before a final cycle of (i) to (iii) such that the amount of the effluent dialysis fluid determined in (vi) is pumped during the at least one subsequent patient drain phase.

### Claim 2 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes executing a plurality of instructions stored on at least one memory device for each of (i) to (vii).

### Claim 3 (depends on 1)

The automated peritoneal dialysis method of claim 1, wherein the at least two trended UF data points are averaged.

### Claim 4 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes obtaining the at least two trended UF data points from a local peritoneal dialysis machine or a remote database.

### Claim 5 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes using the at least two trended UF data points on a trend of multiple UF data points.

### Claim 6 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes using the at least two trended UF data points specific to a particular dialysis fluid.

### Claim 7 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes using the at least two trended UF data points with a programmed volume for at least one of the fill phases to determine the amount of effluent dialysis fluid to remove.

### Claim 8 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes adding the trended UF data points to a programmed volume for at least one of the fill phases and multiplying the sum by a percentage to determine the amount of effluent dialysis fluid to remove.

### Claim 9 (depends on 8)

The automated peritoneal dialysis method of claim 8, which includes setting the percentage so as to ensure that the amount of effluent dialysis fluid can be removed in each of a plurality of patient drain phases.

### Claim 10 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes adding the trended UF data points to a programmed volume for at least one of the fill phases to determine the amount of effluent dialysis fluid to remove.

### Claim 11 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes determining an actual amount of UF removed over the treatment, and using the actual amount removed to update a UF trend that includes the at least two trended UF data points.

### Claim 12 (depends on 1)

The automated peritoneal dialysis method of claim 1, which includes determining an amount of effluent dialysis fluid removed from the patient during an initial drain without using the at least two trended UF data points.

### Claim 13 (depends on 1)

The automated peritoneal dialysis method of claim 1, wherein the final cycle of (i) to (iii) is a final fill cycle.

### Claim 14

An automated peritoneal dialysis method comprising:
pumping dialysis fluid to and from a patient over a treatment according to a plurality of patient fills, dwells, and drains; and
operating a processor to
(i) determine trended ultrafiltration (“UF”) data points corresponding to an amount of UF removed from the patient during the patient drains,
(ii) access the trended UF data points for the patient,
(iii) determine at least one of (a) a subsequent fill volume and (b) a subsequent drain volume based on at least two of the trended UF data points to predict the patient's intra-peritoneal volume (“IPV”) at an end of at least one of the plurality of patient dwells, and
(iv) perform at least one subsequent patient fill, dwell, and drain before a final patient fill and drain such that dialysis fluid is pumped based on the at least one of (a) and (b) determined in (iii).

### Claim 15 (depends on 14)

The automated peritoneal dialysis method of claim 14, wherein the at least two trended UF data points used are (i) most recent UF trended data points or (ii) an average of the at least two trended UF data points.

### Claim 16 (depends on 14)

The automated peritoneal dialysis method of claim 14, which includes updating a UF trend based on an actual UF removed over the treatment.

### Claim 17 (depends on 14)

The automated peritoneal dialysis method of claim 14, which includes adding a measured patient fill amount to at least one UF data point used to determine the IPV.

### Claim 18 (depends on 14)

The automated peritoneal dialysis method of claim 14, which includes subtracting a measured patient drain amount from the IPV to determine a residual amount of effluent left within the patient after one of the plurality of drains.

### Claim 19

An automated peritoneal dialysis method comprising:
controlling dialysis fluid to and from a patient over a tidal treatment including a plurality of patient fills, dwells, and reduced-volume drains; and
operating a processor to
(i) determine trended ultrafiltration (“UF”) data points corresponding to an amount of UF removed from the patient during the patient drains,
(ii) access the trended UF data points for the patient,
(iii) predict a residual volume of effluent fluid left in the patient's peritoneum after at least one of the reduced-volume patient drains during the tidal treatment based on at least two of the trended UF data points, and
(iv) perform at least one subsequent patient fill, dwell, and reduced-volume drain before a final patient fill and drain such that at least one of the patient fill and the reduced-volume drain of the at least one subsequent patient fill, dwell, and reduced-volume drain are adjusted based on the residual volume predicted in (iii).

### Claim 20 (depends on 19)

The automated peritoneal dialysis method of claim 19, which includes adding a measured fill amount to at least one UF data point to determine an intra-peritoneal volume (“IPV”) for the patient and subtracting a measured drain amount to determine the residual volume.

### Claim 21 (depends on 19)

The automated peritoneal dialysis method of claim 19, which includes executing a plurality of instructions stored on at least one memory device for said controlling of the dialysis fluid over the tidal treatment.
