Method and device to manage fluid volumes in the body

• US 10,076,283 B2
• Filed: 11/12/2014
• Issued: 09/18/2018
• Est. Priority Date: 11/04/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Soykan, Orhan, Hobot, Christopher M., Gerber, Martin T., Manda, VenKatesh R.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/539,437
• Publication Number:
  US 20150250427A1
• Time in Patent Office: 1,406 Days
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/08 Detecting, measuring or recording devices for evaluating the respiratory organs A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/4875 Hydration status, fluid retention of the body
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• CPC Class Codes: A61M 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/282 Operational modes
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/50 : for simulation or modelling of medical disorders
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

Abstract

A system and method for determining the amount of fluid to be removed from a dialysis patient is disclosed. The system utilizes sensors and a computer. The computer obtains the input parameters from the sensors, along with information added directly by the user, and performs a forward algorithm to determine a recommended change in patient fluid level. As fluid is removed, the effect of the removal on the parameters is detected by the sensors and re-transmitted back to the computer. The computer then performs a backward algorithm to refine the variables used in the forward algorithm and obtain more accurate results. The system and method provide for changing the amount of fluid removed from the patient based on the results of the algorithm and the data received from the sensors.

Claims

1. A method, comprising the steps of:

obtaining one or more parameters correlated for fluid removal from a patient connected to a first medical device configured to obtain the one or more parameters;

transferring data for the one or more parameters to a medical device processor wherein the medical device processor utilizes the one or more parameters in a forward algorithm to generate a recommended fluid level, the medical device processor determining the recommended fluid level; and

adjusting fluid removal via a second medical device from the patient based on the recommended fluid level;

wherein the forward algorithm is presented by the equation;

2. The method of claim 1, wherein the step of obtaining includes obtaining one or more parameters positively correlated for fluid removal and one or more parameters negatively correlated for fluid removal, wherein the medical device processor processes the one or more positively correlated parameters using a first function and processes the one or more negatively correlated parameters using a second function.

3. The method of claim 2, wherein the one or more parameters positively correlated for fluid removal are selected from the group consisting of atrial fibrillation burden, respiratory rate, sleep pattern, dialysis markers, patient weight, patient medications and dosage, patient supplied data indicative of fluid removal, and clinical data indicative of fluid removal.

4. The method of claim 2, wherein the one or more parameters negatively correlated for fluid removal are selected from the group consisting of tissue impedance, ambulatory heart rate variability, body temperature, heart rate change during dialysis, heart rate variability during dialysis, blood pressure reduction during dialysis, mixed venous oxygen saturation, and patient medications and dosage indicative of fluid retention.

5. The method of claim 2, wherein the one or more parameters positively correlated for fluid removal include pulmonary arterial pressure, venous pressure, and atrial pressure.

6. The method of claim 1, wherein the one or more of the parameters are obtained from the patient prior to dialysis.

7. The method of claim 1, wherein one or more of the parameters are obtained from measurements made during dialysis.

8. The method of claim 1, wherein one or more of the parameters are obtained from the patient'"'"'s medical records.

9. The method of claim 1, wherein the parameters are atrial fibrillation burden, tissue impedance, heart rate variability, sleep pattern and body weight.

10. The method of claim 1, further comprising the step of changing the fluid level in the patient to the recommended fluid level by ultrafiltration.

11. The method of claim 1, further comprising adjusting the weighting coefficient, the off-set coefficient and the scaling coefficient during dialysis by using a backward algorithm, wherein the backward algorithm utilizes data from two or more dialysis sessions of the patient.

12. The method of claim 1, wherein the step of connecting includes obtaining a category one parameter from an implantable device and a category two parameter from a dialysis session.

13. The method of claim 12, wherein the step of obtaining further includes obtaining a category three parameter from a medical device different from the implantable device.

14. The method of claim 12, wherein the step of transferring data includes transferring at least one parameter of a category to a first data area in the medical device processor and transferring the parameter of a category to a second data area in the medical device processor, and wherein the first and second data areas received by the medical processor are implemented using the forward algorithm.

15. The method of claim 1, wherein the medical device processor continuously updates the recommended fluid level using a backward algorithm during a dialysis session.

16. The method of claim 1, wherein the one or more parameters include at least one of serum creatinine level and BNP level.

17. A system, comprising:

a first medical device to generate one or more parameters correlated for fluid removal in a patient;

a medical device processor;

wherein the first medical device transfers data for the one or more parameters to the medical device processor, wherein the medical device processor programmed with a forward algorithm to generate a recommended fluid level in the patient, the medical device processor determining the recommended fluid level; and

a second medical device to adjust fluid removal from the patient based on the recommended fluid level;

wherein the forward algorithm is presented by the equation;

18. The system of claim 17, wherein the forward algorithm computes by utilizing one or more parameters positively correlated for fluid removal and one or more parameters negatively correlated for fluid removal.

19. The system of claim 18, wherein the one or more parameters positively correlated for fluid removal are selected from the group consisting of atrial fibrillation burden, respiratory rate, sleep pattern, dialysis markers, patient weight, patient medications and dosage, patient supplied data indicative of fluid removal, and clinical data indicative of fluid removal.

20. The system of claim 18, wherein the one or more parameters positively correlated for fluid removal are selected from the group consisting of pulmonary arterial pressure, venous pressure, and atrial pressure.

21. The system of claim 18, wherein the one or more parameters negatively correlated for fluid removal are selected from the group consisting of tissue impedance, ambulatory heart rate variability, body temperature, heart rate change during dialysis, heart rate variability during dialysis, blood pressure reduction during dialysis, mixed venous oxygen saturation, and patient medications and dosage indicative of fluid retention.

22. The system of claim 17, wherein n is between 5 and 100.

23. The system of claim 17, wherein the first medical device includes an implantable device and the second medical device includes a dialyzer.

24. The system of claim 17, further comprising a signaling mechanism to signal when there is a recommended change in the patient'"'"'s fluid level.

25. The system of claim 17, wherein the medical device processor continuously updates the recommended fluid level using a backward algorithm during a dialysis session.

26. The system of claim 17, wherein the one or more parameters include at least one of serum creatinine level and BNP level.