# US 9,750,862 B2 · Adaptive system for blood fluid removal

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- Number: US 9,750,862 B2
- Document ID: US9750862B2
- Status: Granted
- Kind: B2
- Application number: 13/424,533
- Filed: 2012-03-20
- Published: 2012-11-01
- Granted: 2017-09-05
- Earliest claimed: 2011-04-29
- Assignees: Medtronic, Inc.
- Applicants: Martin Gerber; John Burnes; Suping Lyu; VenKatesh R. Manda; Bryant Pudil
- Inventors: Martin Gerber; John Burnes; Suping Lyu; VenKatesh R. Manda; Bryant Pudil
- Web page: https://patentgrep.com/patent/US9750862B2

## CPC

- A61M 1/1603: {Regulation parameters}
- A61B 5/0031: {Implanted circuitry}
- A61B 5/026: Measuring blood flow {(A61B3/1233, A61B3/1241 take precedence)}
- A61B 5/0295: using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
- A61B 5/053: Measuring electrical impedance or conductance of a portion of the body
- A61B 5/0537: Measuring body composition by impedance, e.g. tissue hydration or fat content
- A61B 5/145: Measuring characteristics of blood in vivo, e.g. gas concentration or pH-value {; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid or cerebral tissue} (non-radiation detecting or locating of foreign bodies in blood A61B5/06)
- A61B 5/14503: {invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors (A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence)}
- A61B 5/14535: {for measuring haematocrit}
- A61B 5/14539: {for measuring pH}
- A61B 5/14546: {for measuring analytes not otherwise provided for, e.g. ions, cytochromes}
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/4848: {Monitoring or testing the effects of treatment, e.g. of medication}
- A61B 5/6866: {Extracorporeal blood circuits, e.g. dialysis circuits}
- A61M 1/00: Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems (catheters A61M25/00; tube connectors, tube couplings, valves or branch units specially adapted for medical use A61M39/00; devices for taking samples of blood A61B5/15; filters implantable into blood vessels A61F2/01)
- 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}
- A61M 1/16: with membranes
- A61M 1/1601: {Control or regulation}
- A61M 1/1605: {Physical characteristics of the dialysate fluid}
- A61M 1/1607: {before use, i.e. upstream of dialyser}
- A61M 1/1613: {Profiling or modelling of patient or predicted treatment evolution or outcome}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3403: {Regulation parameters}
- A61M 1/342: {Adding solutions to the blood, e.g. substitution solutions (for preventing coagulation A61M1/3672)}
- A61M 1/3607: {Regulation parameters}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- A61M 1/361: {before treatment}
- A61M 1/3612: {after treatment}
- B01D 61/00: Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor (separation of gases or vapours by diffusion B01D53/22)
- B01D 61/32: Controlling or regulating
- B01D 65/02: Membrane cleaning or sterilisation {; Membrane regeneration}
- G16H 20/17: delivered via infusion or injection
- G16H 20/40: relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
- G16H 40/63: for local operation
- G16H 50/70: for mining of medical data, e.g. analysing previous cases of other patients
- G16Z 99/00: Subject matter not provided for in other main groups of this subclass
- A61B 2560/0223: of calibration, e.g. protocols for calibrating sensors
- A61M 2205/04: implanted
- A61M 2205/18: with alarm
- A61M 2205/33: Controlling, regulating or measuring
- A61M 2205/3303: Using a biosensor
- A61M 2205/3306: Optical measuring means
- A61M 2205/3313: used specific wavelengths
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3375: Acoustical, e.g. ultrasonic, measuring means
- A61M 2205/3523: using telemetric means
- A61M 2205/50: with microprocessors or computers
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/60: with identification means
- A61M 2205/70: with testing or calibration facilities
- A61M 2230/00: Measuring parameters of the user
- A61M 2230/005: Parameter used as control input for the apparatus
- A61M 2230/20: Blood composition characteristics
- A61M 2230/207: hematocrit
- A61M 2230/208: pH-value
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- B01D 2321/12: Use of permeate
- B01D 2321/40: Automatic control of cleaning processes
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16Z: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS, NOT OTHERWISE PROVIDED FOR

## Abstract

Methods for monitoring patient parameters and blood fluid removal system parameters include identifying those system parameters that result in improved patient parameters or in worsened patient parameters. By comparing the patient's past responses to system parameters or changes in system parameters, a blood fluid removal system may be able to avoid future use of parameters that may harm the patient and may be able to learn which parameters are likely to be most effective in treating the patient in a blood fluid removal session.

## Claims

### Claim 1

A method carried out by a blood fluid removal system, comprising:
initiating a blood fluid removal session, using a blood fluid removal device, with initial system parameters;
acquiring a first set of data regarding one or more patient physiological parameters, wherein the one or more patient physiological parameters include at least one of pH and concentration of an electrolyte;
storing the first data set in a most effective to date data set memory;
associating the initial system parameters in an increased effectiveness lookup table with the first data set;
adjusting at least one parameter of the blood fluid removal session by adjusting the blood fluid removal system to arrive at adjusted system parameters;
acquiring a second set of data regarding the one or more patient physiological parameters after the at least one parameter of the blood fluid removal session has been adjusted; and
determining which of the first and second set of data includes at least one value closer to a target value; storing in the increased effectiveness lookup table data regarding the data set having at least one value closer to the target value; and associating data regarding the adjusted system parameters with the data set having at least one value closer to the target value; and
repeating the process beginning with acquiring a first set of data regarding one or more patient physiological parameters;
storing the first data set in a least effective to date data set memory;
associating the initial system parameters in a decreased effectiveness lookup table with the first data set prior to adjusting the at least one parameter of the blood fluid removal session;
determining which of the first and second set of data includes at least one value further from the target value; storing in the decreased effectiveness lookup table data regarding the data set having at least one value further from the target value; and associating data regarding the adjusted system parameters with the data set having at least one value further from to the target value;
replacing the data in the least effective to date data set with the data from the data set having at least one value further from the target value; and
continuing the blood fluid removal session with the system parameters in the most effective to date data set;
wherein the blood fluid removal system performs at least one blood fluid removal process selected from the group consisting of ultrafiltration, hemofiltration, hemodialysis, hemodiafiltration and peritoneal dialysis.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
further adjusting at least one parameter of the blood fluid removal session to arrive at further adjusted system parameters;
acquiring a third set of data regarding the one or more patient physiological parameters after the at least one parameter of the blood fluid removal session has been further adjusted; and
determining which of the first and third sets of data includes at least one value and storing in the increased effectiveness lookup table data regarding the data set and associating data regarding the further adjusted system parameters with the data set having at least one value closer to the target value.

### Claim 3 (depends on 1)

The method of claim 1, further comprising:
further adjusting at least one parameter of the blood fluid removal session to arrive at further adjusted system parameters;
acquiring a fourth set of data regarding the one or more patient physiological parameters after the at least one parameter of the blood fluid removal session has been further adjusted; and
determining which of the first, second and fourth set of data includes at least one value further from the target value; and storing in the decreased effectiveness lookup table data regarding the data set having at least one value further from the target value and associating data regarding the further adjusted system parameters with the data set having at least one value further from the target value.

### Claim 4 (depends on 1)

The method of claim 1, further comprising:
acquiring a fifth set of data regarding one or more patient physiological parameters;
comparing the fifth data set to the increased effectiveness lookup table; and
determining whether at least one parameter of the data set stored in the increased effectiveness table is within a predetermined range of the fifth data set; and adjusting the system parameters associated with the data set stored in the increased effectiveness lookup table if the at least one parameter of the data set stored in the increased effectiveness lookup table is within the predetermined range of the fifth data set.

### Claim 5 (depends on 1)

The method of claim 1, further comprising:
stopping the blood fluid removal session;
acquiring a sixth set of data regarding one or more patient physiological parameters;
comparing the sixth data set to the increased effectiveness lookup table; and
initiating a second blood fluid removal session with the system parameters associated with the data set stored in the increased effectiveness lookup table if at least one parameter of a data set stored in the increased effectiveness lookup table is within a predetermined range of at least one parameter of the sixth data set.

### Claim 6 (depends on 1)

The method of claim 1, wherein the at least one of the one or more patient parameters also include at least one parameter selected from the group consisting of blood pressure and heart rate.

### Claim 7 (depends on 1)

The method of claim 1, wherein the electrolyte is potassium.

### Claim 8 (depends on 1)

The method of claim 1, wherein the system parameters comprise one or more of fluid removal rate and concentration of one or more electrolyte.

### Claim 9

A non-transitory computer-readable medium comprising instructions that, when executed by a blood fluid removal device, cause the device to
initiate a blood fluid removal session with initial system parameters;
acquire a first set of data regarding one or more patient physiological parameters, wherein the one or more patient physiological parameters include at least one of pH and concentration of an electrolyte;
store the first data set in a most effective to date data set memory;
associate the initial system parameters in an increased effectiveness lookup table with the first data set;
adjust at least one parameter of the blood fluid removal session by adjusting the blood fluid removal system to arrive at adjusted system parameters;
acquire a second set of data regarding the one or more patient physiological parameters after the at least one parameter of the blood fluid removal session has been adjusted; and
determine which of the first and second set of data includes at least one value closer to a target value; store in the increased effectiveness lookup table data regarding the data set having at least one value closer to the target value; and associate data regarding the adjusted system parameters with the data set having at least one value closer to the target value;
repeat the process beginning with acquiring a first set of data regarding one or more patient physiological parameters;
store the first data set in a least effective to date data set memory;
associate the initial system parameters in a decreased effectiveness lookup table with the first data set prior to adjusting the at least one parameter of the blood fluid removal session;
determine which of the first and second set of data includes at least one value further from the target value; store in the decreased effectiveness lookup table data regarding the data set having at least one value further from the target value; and associate data regarding the adjusted system parameters with the data set having at least one value further from to the target value;
replace the data in the least effective to date data set with the data from the data set having at least one value further from the target value; and
continue the blood fluid removal session with the system parameters in the most effective to date data set;
wherein the blood fluid removal system performs at least one blood fluid removal process selected from the group consisting of ultrafiltration, hemofiltration, hemodialysis, hemodiafiltration and peritoneal dialysis.