Multimodal dialysis system

• US 9,132,217 B2
• Filed: 03/15/2013
• Issued: 09/15/2015
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Soykan, Orhan, Pudil, Bryant J., Meyer, Thomas E., Ruetz, Linda L., Schu, Carl
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US13/844,599
• Publication Number:
  US 20130274642A1
• Time in Patent Office: 914 Days
• Field of Search: 604/5.01, 604/5.04, 604/6.09, 604/6.11, 604/4.01, 210/645, 210/646, 210/746
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• 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 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6866 Extracorporeal blood circuits, e.g. dialysis circuits
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3427 : back through the membrane, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 1/3458 : having electrolytes not present in the dialysate
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/332 : Force measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 : using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/207 : hematocrit
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 2230/60 : Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: B01D 2311/246 : Concentration control
• CPC Class Codes: B01D 2321/12 : Use of permeate
• CPC Class Codes: B01D 2321/40 : Automatic control of cleaning processes
• CPC Class Codes: B01D 61/243 : Dialysis
• CPC Class Codes: B01D 61/244 : comprising multiple dialysis steps
• CPC Class Codes: B01D 61/30 : Accessories; Auxiliary operation
• CPC Class Codes: B01D 61/32 : Controlling or regulating
• CPC Class Codes: B01D 65/02 : Membrane cleaning or sterilisation ; Membrane regeneration

Abstract

A dialysis device for operation in multiple modes and for maintaining a known gradient of potassium ion or other electrolyte between the blood of a patient and a dialysate fluid is described. The dialysis device is capable of being used for hemodialysis or peritoneal dialysis, and the dialysis device is capable of operation with a dialysate purification unit outside of a clinical setting or with a supply of water that can be supplied in a clinical setting. The dialysis device has a composition sensor containing a potassium-sensitive electrode for measuring a potassium ion concentration in one or more of the patient'"'"'s blood and the dialysate fluid and an infusate pump operated to adjust a potassium ion concentration in the dialysate fluid based at least in part on data from the composition sensor.

Claims

1. A multimodal dialysis apparatus, comprising:

an extracorporeal flow path for transporting blood of a subject to a hemodialysis unit;

at least one of an electrocardiogram sensor and an electromyogram sensor configured to detect a change in muscle activity or nerve activity of the subject and configured to produce at least one electrical signal based on the change in muscle activity or nerve as detected, the electrical signal being indicative of a serum potassium concentration;

a dialysate flow path configured to transport a dialysate fluid to the hemodialysis unit; and

an infusate pump comprising a potassium solution in fluid communication with the dialysate flow path such that the infusate pump configured to adjust a potassium concentration in the dialysate flow path based at least in part on the serum potassium concentration obtained via the at least one of the electromyogram sensor and the electrocardiogram sensor.

2. The multimodal dialysis apparatus of claim 1, further comprising one or more detectors including at least one of a nerve electrogram amplifier, an accelerometer, a strain gauge, and a pressure gauge for detecting the change in muscle activity.

3. The multimodal dialysis apparatus of claim 1, wherein the medical device is externally applicable to or implantable in the subject.

4. The multimodal dialysis apparatus of claim 1, wherein the electromyogram sensor is a skeletal muscle strain sensor.

5. The multimodal dialysis apparatus of claim 1, wherein the electromyogram sensor is a blood pressure sensor.

6. The multimodal dialysis apparatus of claim 1, wherein the electrocardiogram sensor includes one or more electrocardiogram electrodes for receiving one or more electrocardiogram features from the subject, the one or more electrocardiogram features including T-wave amplitude, R-wave amplitude, T-slope, ratio of T-wave amplitude to R-wave amplitude (T/R ratio), and T-wave flatness.

7. The multimodal dialysis apparatus of claim 6, further comprising an electrocardiogram algorithm for producing an output on serum potassium concentration in the subject based on a value of the one or more electrocardiogram features, wherein the electrocardiogram algorithm includes one or more of the following operational rules:

i) the output on the serum potassium concentration being a function of the R-wave amplitude;

ii) the output on the serum potassium concentration being a function of the T-wave amplitude;

iii) the output on the serum potassium concentration being a function of the T/R ratio; and

iv) the output on the serum potassium concentration being a function of the T-wave flatness.

8. The multimodal dialysis apparatus of claim 7, wherein the output on the serum potassium concentration is a difference between a serum potassium concentration at time t₁ of the subject and a baseline potassium concentration at time t₀ of the subject, time t₁ being at least 10 minutes apart from t₀.

9. The multimodal dialysis apparatus of claim 8, wherein the baseline serum potassium concentration is a value selected from the group consisting of a baseline serum potassium concentration of the subject obtained at a periodic blood draw, a baseline serum potassium concentration of the subject obtained at the onset of a dialysis session, and a baseline serum potassium concentration of the subject at the end of a dialysis session.

10. The multimodal dialysis apparatus of claim 1, wherein the electromyogram sensor is a nerve electrogram sensor.

11. The multimodal dialysis apparatus of claim 9, wherein the R-wave amplitude of operational rule i) is a difference between an R-wave amplitude at time t₁ of the subject and a baseline R-wave amplitude at time t₀ of the subject, the T-wave amplitude of operational rule ii) is a difference between a T-wave amplitude at time t₁ of the subject and a baseline T-wave amplitude at time t₀ of the subject, the T/R ratio of operational rule iii) is a difference between a T/R ratio at time t₁ of the subject and a baseline T/R ratio at time t₀ of the subject, and the T-wave flatness of operational rule iv) is a difference between an T-wave flatness at time t₁ of the subject and a baseline T-wave flatness at time t₀ of the subject.

12. The multimodal dialysis apparatus of claim 10, wherein the baseline potassium concentration of the subject is 3.0 to 5.5 mM at time t₀.

13. The multimodal dialysis apparatus of claim 6, wherein the one or more electrocardiogram electrodes include one or more of lead II, lead V2, lead V3 and lead V4.

14. The multimodal dialysis apparatus of claim 6, wherein the one or more electrocardiogram electrodes consist of lead II only.

15. The multimodal dialysis apparatus of claim 7, wherein the electrocardiogram algorithm includes one or more of the operational rules i), iii) and iv).

16. The multimodal dialysis apparatus of claim 7, wherein the output on the serum potassium concentration is in positive correlation with the R-wave amplitude.

17. The multimodal dialysis apparatus of claim 7, wherein the output on the serum potassium concentration is in negative correlation with the T-wave amplitude.

18. The multimodal dialysis apparatus of claim 7, wherein the output on the serum potassium concentration is in negative correlation with the T-slope.

19. The multimodal dialysis apparatus of claim 7, wherein the output on the serum potassium concentration is in positive correlation with the T-wave flatness.

20. The multimodal dialysis apparatus of claim 7, wherein the one or more electrocardiogram electrodes includes a first set of electrodes consisting of lead II, lead V2, lead V3 and lead V4, and a second set of electrodes consisting of lead II only, wherein the electrocardiogram algorithm further includes a calibration rule that the multimodal dialysis apparatus is operationally calibrated if one or more of the following is met:

v) a difference between the outputs according to rule ii) from the first set of electrodes and the second set of electrodes is no greater than 20%;

vi) a difference between the outputs according to rule iii) from the first set of electrodes and the second set of electrodes is no greater than 20%; and

vii) a difference between the outputs according to rule iv) from the first set of electrodes and the second set of electrodes is no greater than 20%.

21. The multimodal dialysis apparatus of claim 7, wherein the one or more electrocardiogram electrodes includes a first set of electrodes consisting of lead II, lead V 2, lead V3 and lead V4, and a second set of electrodes consisting of lead II only, wherein the electrocardiogram algorithm further includes a calibration rule that the multimodal dialysis apparatus is operationally calibrated if one or more of the following is met:

v) a difference between the outputs according to rule ii) from the first set of electrodes and the second set of electrodes is no greater than 10%;

vi) a difference between the outputs according to rule iii) from the first set of electrodes and the second set of electrodes is no greater than 10%; and

vii) a difference between the outputs according to rule iv) from the first set of electrodes and the second set of electrodes is no greater than 10%.

22. The multimodal dialysis apparatus of claim 1, further comprising one or more potassium-sensitive electrodes for measuring a potassium ion concentration in the dialysate flow path.

23. A method for conducting a dialysis treatment in a subject, the dialysis treatment being conducted with an extracorporeal flow path for transporting blood of the subject to a hemodialysis unit, a dialysate flow path for transporting a dialysate fluid to the hemodialysis unit, and an infusate pump in potassium communication with the dialysate flow path, the method comprising:

connecting at least one electrocardiogram sensor to a subject to receive one or more electrocardiogram features;

applying an electrocardiogram algorithm to the one or more electrocardiogram features to obtain an indicator for serum potassium concentration of the subject, wherein the electrocardiogram algorithm includes one or more of the following operational rules;

i) the output on the serum potassium concentration being a function of an R-wave amplitude;

ii) the output on the serum potassium concentration being a function of an T-wave amplitude;

iii) the output on the serum potassium concentration being a function of a T/R ratio; and

iv) the output on the serum potassium concentration being a function of a T-wave flatness; and

adding an amount of potassium via the infusate pump into the dialysate flow path, wherein the amount of potassium is determined based at least in part on the serum potassium concentration obtained via the at least the electrocardiogram sensor.