Precision dialysis monitoring and synchronization system

• US 10,617,349 B2
• Filed: 11/26/2014
• Issued: 04/14/2020
• Est. Priority Date: 11/27/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Burnes, John, Manda, VenKatesh, Blumenthal, Tico, Soykan, Orhan
• Primary Examiner(s): Wu, Eugene T
• Application Number:
  US14/555,065
• Publication Number:
  US 20150148697A1
• Time in Patent Office: 1,966 Days
• 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 sensors configured to detect at least one or more medical parameters;

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, and

wherein the processor is a medical device processor configured to use an algorithm to determine a total hazard estimate of a ventricular arrhythmia based on the at least one or more medical parameters, wherein the algorithm, for each of the at least one or more medical parameters, calculates an individual hazard estimate given by y₁(t)=h₁(t)⊗

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 medical parameter at time t, and ⊗

is a convolution operator; and

wherein the total hazard estimate is either a linear or nonlinear summation of individual hazard estimates, and wherein the algorithm utilizes an adaptive filter to alter each of the constants periodically;

wherein the at least one or more medical parameters include at least one of sleep pattern, heart rate change during dialysis, a profile of fluid removed during dialysis session, and sodium level;

wherein the medical device processor determines whether an arrhythmia is due to any one of fluid management, electrolyte management, or both fluid management and electrolyte management;

wherein the medical device processor is configured to provide an adjustment of a future dialysis prescription for a patient based on the total hazard estimate.

2. The medical system of claim 1, wherein the processor is further configured to receive fluid management data and electrolyte management data, and the system comprises a transmitter configured to provide an electronic-mediated communication to a medical server to adjust the frequency of measurements of the at least one or more medical parameters in response to the fluid or electrolyte management data.

3. The medical system of claim 1, 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 at least one sensor is implanted and is configured to electronically transmit data via any one of Bluetooth Low Energy, radio frequency, and cellular technologies.

4. The medical system of claim 1, wherein the at least one medical parameter further comprises a medical parameter selected from the group consisting of heart rate, fluid level, blood ion levels, blood pressure, post-dialysis weight, and pre-dialysis weight and wherein the at least one dialysis session parameter further comprises a dialysis session parameter selected from the group consisting of 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 data from the processor.

6. The medical system of claim 1, wherein the at least one dialysis session parameter is a period of time between dialysis sessions.

7. The medical system of claim 1, wherein the processor is further configured to synchronize the at least one or more medical parameters to the at least one dialysis session parameter.

8. The medical system of claim 1, wherein the processor is configured to utilize an Amoeba algorithm to set initial values for the constants for at least four different medical parameters.

9. The medical system of claim 1, wherein the processor is configured to receive data of the at least one or more medical parameters continuously or in pre-programmed time intervals and wherein the adaptive filter uses the data from any number of days to make dynamic determination of the constants.