Optimizing therapy outcomes for peritoneal dialysis

• US 9,348,975 B2
• Filed: 04/28/2009
• Issued: 05/24/2016
• Est. Priority Date: 05/02/2008
• Status: Active Grant

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Inventors: Lo, Ying-Cheng, Akonur, Alp, Martis, Isaac
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US12/431,458
• Publication Number:
  US 20090275881A1
• Time in Patent Office: 2,583 Days
• Field of Search: 604/29, 604/28, 604/5.01, 604/5.04, 604/27, 600/300, 600/587, 703/2, 700/100
• US Class Current: 1/1
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/159 specially adapted for peritoneal dialysis
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/281 Instillation other than by gravity
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture

Abstract

Peritoneal dialysis therapy outcomes have been calculated for a variety of dwell times of peritoneal dialysis fluids in the peritoneal cavities of dialysis patients using kinetic modeling. The length of dwell time should not be the same for every patient, but should vary according to the patient condition and needs. Some patients have a potential for expressing greater ultrafiltrate into the dialysis fluid, and these patients can benefit from a longer dwell time, whereas other patients with less potential will not benefit from a longer dwell time. An optimal or peak time is observed for each peritoneal dialysis therapy outcome, such as ultrafiltrate volume rate, urea clearance (Kt/V), and creatinine clearance, while minimizing hydrocarbon absorption. These values and input parameters can be used to tailor the peritoneal dialysis dwell time for each patient, estimating the peak dwell time that will yield the best therapy outcome for each patient.

Claims

1. A method for accomplishing automated peritoneal dialysis, comprising:

administering a peritoneal equilibration test (“

PET”

) to a patient;

determining and recording a patient status as a result of the PET test, the patient status selected from the group consisting of a high transporter, average transporter, low transporter, and combinations thereof;

calculating a peritoneal dialysis dwell time based on the patient status and at least one peritoneal dialysis therapy outcome, wherein the dwell time optimizes the at least one peritoneal dialysis therapy outcome for the patient, said calculating including (i) averaging an optimized dwell time for a plurality of peritoneal dialysis therapy outcomes or (ii) using a weighted average of an optimized dwell time of each of the plurality of peritoneal dialysis therapy outcomes; and

performing at least one treatment cycle with the calculated peritoneal dialysis dwell time using an automated peritoneal dialysis machine.

2. The method of claim 1, wherein the step of calculating is based on a plurality of peritoneal dialysis input parameters.

3. The method of claim 1, further comprising storing a database of peritoneal dialysis dwell times, peritoneal dialysis input parameter values and peritoneal dialysis therapy outcomes in a memory of a computer or in a memory accessible to the computer for carrying out the step of calculating.

4. The method of claim 1, wherein the at least one peritoneal dialysis therapy outcome is selected from the group consisting of:

a net ultrafiltrate volume, a net ultrafiltrate volume rate, an absorption of carbohydrates from a peritoneal dialysis fluid, a phosphate removal, a creatinine clearance, and a urea clearance.

5. The method of claim 1, wherein the step of calculating is also based on a composition of a peritoneal dialysis fluid and a peritoneum fill volume.

6. The method of claim 1, further comprising infusing a peritoneal dialysis fluid into a peritoneum of the patient;

and

notifying the patient when the dwell time has elapsed.

7. A method for accomplishing automated peritoneal dialysis, comprising:

determining peritoneal transport properties of a patient;

determining a classification of the peritoneal transport properties of the patient;

calculating a peritoneal dialysis dwell time based on the classification, a plurality of peritoneal dialysis input parameters, and at least one desired peritoneal dialysis therapy outcome, wherein the dwell time is calculated to maximize the at least one desired peritoneal dialysis therapy outcome, said calculating including (i) averaging an optimized dwell time for a plurality of peritoneal dialysis therapy outcomes or (ii) using a weighted average of an optimized dwell time of each of the plurality of peritoneal dialysis therapy outcomes; and

performing at least one treatment cycle with the calculated peritoneal dialysis dwell time using an automated peritoneal dialysis machine.

8. The method of claim 7, further comprising storing data of a correspondence between the plurality of peritoneal dialysis input parameters, a plurality of therapy outcomes, and values of a peritoneal dialysis dwell time in a memory of a computer or in a memory accessible to the computer for carrying out the step of calculating.

9. The method of claim 7, wherein the at least one desired peritoneal dialysis outcome is selected from the group consisting of:

a net ultrafiltrate volume, a net ultrafiltrate volume rate, a reduction in absorption of carbohydrates from a peritoneal dialysis fluid, a urea clearance, a sodium clearance, a middle molecule clearance, and a creatinine clearance.

10. The method of claim 7, wherein the step of calculating is based on a body surface area or a total body water volume of a patient.

11. The method of claim 7, further comprising infusing a peritoneal dialysis fluid into a peritoneum of the patient;

notifying the patient when the dwell time has elapsed; and

removing the peritoneal dialysis fluid from the peritoneum after the dwell time.

12. A system for calculating a peritoneal dialysis dwell time and conducting automated peritoneal dialysis, the system comprising:

a processor for operating an automated peritoneal dialysis machine;

a memory of the processor or a memory accessible to the processor, the memory storing a look-up table containing peritoneal dialysis input parameters, peritoneal dialysis therapy outcomes, and peritoneal dialysis dwell times corresponding to the input parameters and dwell times; and

a software program stored in the memory of the processor or the memory accessible to the processor for receiving a selection or an input of at least one desired therapy outcome of a patient and calculating a dwell time for the patient for optimizing the at least one peritoneal dialysis therapy outcome for the patient, wherein the dwell time is calculated by (i) averaging an optimized dwell time for a plurality of peritoneal dialysis therapy outcomes or (ii) using a weighted average of an optimized dwell time of each of the plurality of peritoneal dialysis therapy outcomes.

13. The system of claim 12, wherein the plurality of peritoneal dialysis therapy outcomes include at least two of a net ultrafiltrate volume, an absorption of carbohydrates, a urea clearance, a phosphate clearance, and a creatinine clearance.

14. The system of claim 12, wherein the look-up table includes input parameters based on transport properties of the patient, a composition of a peritoneal dialysis fluid, and a peritoneum fill volume, and optionally, a body surface area of the patient or a total body volume of the patient.

15. The system of claim 12, further comprising a housing for the computer system and an input device for inputting at least one peritoneal dialysis input parameter, a composition of a peritoneal dialysis fluid, and inputting or selecting the at least one dialysis therapy outcome.

16. The system of claim 12, further comprising a remote device in communication with the computer system, the remote device including an output device for indicating an end of the dwell time or a time remaining of the dwell time.

17. The system of claim 12, further comprising a patient transfer set, including an output device for indicating an end of the dwell time or a time remaining of the dwell time.

18. The system of claim 12, further comprising a peritoneal dialysis machine, wherein the processor forms part of a control system of the peritoneal dialysis machine.

19. A computer program embodied on a computer readable medium for calculating a peritoneal dialysis dwell time, comprising:

a code segment for accessing data of a correspondence between a plurality of peritoneal dialysis input parameters, a plurality of peritoneal dialysis therapy outcomes, and a plurality of peritoneal dialysis dwell times;

a code segment that allows a user to input or to select at least one peritoneal dialysis input parameter from the plurality of peritoneal dialysis input parameters and at least one desired therapy outcome;

a code segment that receives an indication of the at least one input parameter and at least one desired therapy outcome selected by the user;

a code segment that calculates a dwell time corresponding to the at least one desired therapy outcome selected by the user, said code configured to calculate the dwell time by (i) averaging an optimized dwell time for a plurality of peritoneal dialysis therapy outcomes or (ii) using a weighted average of an optimized dwell time of each of the plurality of peritoneal dialysis therapy outcomes; and

a code segment that inputs the dwell time to an automated peritoneal dialysis machine.

20. The computer program according to claim 19 wherein the at least one desired therapy outcome is selected from the group consisting of:

a net ultrafiltrate volume, a net ultrafiltrate volume rate, an absorption of carbohydrates from a peritoneal dialysis fluid, a urea clearance, and a creatinine clearance.

21. The computer program according to claim 19, further comprising the data, said data stored on the computer-readable medium or in a memory accessible by the computer readable medium as a look-up table or as one or more formulae that express the correspondence.

22. An automated peritoneal dialysis system, comprising:

a dialysis cassette and a housing suitable for receiving the cassette, the cassette including at least one pump for pumping dialysis fluid to and from a patient;

a microcontroller suitable for operating the automated peritoneal dialysis system;

a memory of the microcontroller or accessible to the microcontroller, the memory including data of a plurality of dialysis input parameters, a plurality of dialysis dwell times, and a plurality of therapy outcomes corresponding to the input parameters and dwell times, wherein a user instructs the microcontroller to select or calculate a dwell time for optimizing at least one dialysis outcome for a patient; and

a patient transfer device connected to a patient access device, the patient transfer device including electronics in communication with the microcontroller.