PRECISION DIALYSIS MONITORING AND SYNCHONIZATION SYSTEM

• US 20150148697A1
• Filed: 11/26/2014
• Published: 05/28/2015
• Est. Priority Date: 11/27/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: BLUMENTHAL, Tico, Soykan, Orhan, BURNES, John, MANDA, VenKatesh
• Granted Patent: US 10,617,349 B2
• Time in Patent Office: Days
• US Class Current: 600/513
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• 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 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/361 Detecting fibrillation
• CPC Class Codes: A61B 5/363 Detecting tachycardia or bradycardia
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• 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 40/67 for remote operation
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

A system and method for synchronizing patient medical parameters and dialysis parameters. The system and related method allow for the determination of the effect of dialysis on patient health. The invention also allows for the determination of whether observed patient health effects are due to specific dialysis parameters and for making necessary changes to the dialysis parameters in order to improve patient health.

Claims

1. A medical system, comprising:

one or more external or implantable sensor configured to detect at least one medical parameter;

an input configured to receive at least one dialysis session parameter; and

a processor in electronic communication with the one or more external or implantable sensor and the input, wherein the processor is configured to synchronize the medical parameter to the at least one dialysis session parameter to determine whether an arrhythmia is related to an occurrence of dialysis.

2. The medical system of claim 1, wherein the processor receives fluid management data and electrolyte management data, and determines whether an arrhythmia is due to any one of fluid management, electrolyte management, or both fluid management and electrolyte management and wherein the system provides an electronic-mediated communication to a medical server based on the determination of whether the arrhythmia is due to any one of fluid management, electrolyte management, or both fluid management and electrolyte management or the system provides an electronic-mediated communication to a medical server to adjust monitoring.

3. The medical system of claim 2, wherein the electronic-mediated communication is electronically transmitted to one or more of a data hub, a handheld data receiver, or a patient electronic medical record and wherein the sensor is implanted and electronically transmits data via any one of Bluetooth Low Energy, radio frequency, and cellular technologies.

4. The medical system of claim 1, wherein the medical parameter is selected from the group consisting of arrhythmia information, heart rate, fluid level, blood ion levels, blood pressure, post-dialysis weight, and pre-dialysis weight and wherein the dialysis session parameter is selected from the group consisting of an occurrence of dialysis, fluid removal rate, dialysate electrolyte composition, and dialysate pH.

5. The medical system of claim 1, further comprising a non-transitory memory configured to receive and store the synchronized data from the processor.

6. The medical system of claim 1, wherein the processor is a medical device processor using an algorithm to determine a probability of a ventricular arrhythmia based on the physiological parameters, and wherein the algorithm, for each of the one or more physiological parameters of a patient, calculates an individual hazard estimate given by y₁(t)=h₁(t){circle around (×

)}x₁(t), wherein h₁(t)=k₁e^k2t, t is time, y₁(t) is the individual hazard estimate at time t, k₁ and k₂ are constants for the given parameter, x₁(t) is the physiological parameter at time t, and {circle around (×

)} is a convolution operator.

7. A medical monitoring system, comprising:

a medical device comprising one or more sensors configured to sense at least one medical parameter;

an input configured to receive at least one parameter of a dialysis session;

a processor in electronic communication with the medical device and the input configured to obtain the data from the medical device and the input, and to synchronize the data from the medical device and the input; and

an output configured to output the at least one medical parameter and the at least one parameter of a dialysis session, wherein the output is configured to display the at least one medical parameter and at least one parameter of a dialysis session simultaneously.

8. The medical monitoring system of claim 7, wherein the system provides an electronic-mediated communication to a medical server based on a determination of whether the arrhythmia is due to any one of fluid management, electrolyte management, or both fluid management and electrolyte management or the processor provides an electronic-mediated communication to the medical server to adjust monitoring and wherein the at least one medical parameter is selected from the group consisting of arrhythmia information, heart rate, fluid level, blood ion levels, and blood pressure, post-dialysis weight, and pre-dialysis weight.

9. The medical monitoring system of claim 8 wherein the arrhythmia information comprises at least one parameter selected from the group consisting of arrhythmia timing, arrhythmia duration, arrhythmia rate, arrhythmia burden, and arrhythmia type.

10. The medical monitoring system of claim 7 wherein the output comprises a chart showing at least one medical parameter and at least one dialysis parameter on the same chart, and wherein the medical device is configured to continuously monitor the at least one medical parameter.

11. The medical monitoring system of claim 7 wherein the medical device is an implantable medical device and wherein the at least one parameter of a dialysis session is selected from the group consisting of an occurrence of dialysis, dialysis initiation time, a dialysis time length, and a dialysis session prescription.

12. The medical monitoring system of claim 7, wherein the output shows the at least one medical parameter for a preset time before a dialysis session, during the dialysis session and for a preset time after the dialysis session.

13. The medical monitoring system of claim 12 wherein a user can select the preset time before the dialysis session and the preset time after the dialysis session.

14. The medical monitoring system of claim 12 wherein the preset period is selected from between:

1 hour-1 year, 1-2 hours, 1 hour-1 day, 4 hours-7 days, 1 day-1 month, 7 days-30 days, 30 days-6 months, or 4 months-1 year.

15. The medical monitoring system of claim 7 wherein the output shows the at least one medical parameter for a period of time including multiple dialysis sessions and wherein the input is configured to automatically receive the at least one parameter of a dialysis session.

16. The medical monitoring system of claim 15, wherein the input is configured to receive the at least one parameter of a dialysis session from a dialysis machine or a device in communication with a dialysis machine.

17. The medical monitoring system of claim 7 further comprising an interface, wherein the interface is configured to allow for input of at least one parameter of a dialysis session.

18. A method, comprising:

obtaining at least one set of data of at least one medical parameter from a sensor;

obtaining at least one dialysis parameter from a dialysis session performed on a subject;

associating the at least one medical parameter and the at least one dialysis parameter with a time corresponding to the time of obtaining the at least one medical parameter and at least one dialysis parameter.

19. The method of claim 18, further comprising the step of providing a synchronized output showing the at least one set of data of at least one medical parameter and the at least one dialysis parameter as a function of the time and wherein the processor determines whether an arrhythmia is due to fluid management by one or both of:

comparing a fluid level of the patient to a fluid level of the patient before, during or after previous dialysis sessions, wherein the previous dialysis sessions did not result in arrhythmia; and

comparing the rate and magnitude of fluid level drop during a dialysis session within a set time period of the arrhythmia to a rate and magnitude of fluid level drop during a previous dialysis session of the patient, wherein the previous dialysis session did not result in arrhythmia.

20. The method of claim 18, further comprising continuously monitoring the at least one medical parameter for a period of time over multiple dialysis sessions, and wherein the output is a display showing the at least one set of data of at least one medical parameter for a period of time including multiple dialysis sessions, and comprising providing an output showing the at least one set of data of at least one medical parameter for a set time period before the dialysis session, during the dialysis session and after the dialysis session.

21. The method of claim 18 wherein the set time period before the dialysis session and the set time period after a dialysis session are between any of:

1 hour-1 year, 1-2 hours, 1 hour-1 day, 4 hours-7 days, 1 day-1 month, or 7 days-30 days, 30 days-6 months, or 4 months-1 year.

22. The method of claim 18, wherein the at least one set of data of at least one medical parameter is obtained from an implantable medical device, and wherein the at least one dialysis parameter from a dialysis session is obtained automatically from a dialysis machine.

23. The method of claim 18, further comprising adjusting a measurement frequency based any one of an occurrence of arrhythmia, patient fluid level, post-dialysis weight, pre-dialysis weight, or a time duration of arrhythmia.