ADAPTIVE SYSTEM FOR BLOOD FLUID REMOVAL

• US 20120277722A1
• Filed: 03/20/2012
• Published: 11/01/2012
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Burnes, John, Lyu, SuPing, Manda, VenKatesh R., Pudil, Bryant
• Granted Patent: US 9,750,862 B2
• Time in Patent Office: Days
• US Class Current: 604/503
• 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 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: 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
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• 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 5/14503 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
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• 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 1/00 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
• 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 1/1603 Regulation parameters
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1607 : before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1613 : Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/28 : Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 : Regulation parameters
• CPC Class Codes: A61M 1/342 : Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3607 : Regulation parameters
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/361 : before treatment
• CPC Class Codes: A61M 1/3612 : after treatment
• CPC Class Codes: A61M 2205/04 : implanted
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/33 : Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3303 : Using a biosensor
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3523 : using telemetric means
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/70 : with testing or calibration facilities
• CPC Class Codes: A61M 2230/00 : Measuring parameters of the user
• CPC Class Codes: A61M 2230/005 : Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/20 : Blood composition characteristics
• CPC Class Codes: A61M 2230/207 : hematocrit
• CPC Class Codes: A61M 2230/208 : pH-value
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: B01D 2321/12 : Use of permeate
• CPC Class Codes: B01D 2321/40 : Automatic control of cleaning processes
• CPC Class Codes: B01D 61/00 : 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
• CPC Class Codes: B01D 61/32 : Controlling or regulating
• CPC Class Codes: B01D 65/02 : Membrane cleaning or sterilisation ; Membrane regeneration
• 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 40/63 : for local operation
• CPC Class Codes: G16H 50/70 : for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass

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

1. A method carried out by a blood fluid removal system, comprising:

initiating a blood fluid removal session with initial system parameters;

acquiring a first set of data regarding one or more patient physiological parameters;

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 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

if at least one value of the second data set is closer to the target value than a corresponding at least one value of the first data set;

replacing the first data set in the most effective to date data set memory with the second data set;

storing in the increased effectiveness lookup table data regarding the second data set; and

associating data regarding the adjusted system parameters with the second data set.

2. The method of claim 1, further comprising:

storing the first data set in a least effective to date data set memory; and

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;

if the at least one value of the second data set is not closer to the target value than the corresponding at least one value of the first data set;

replacing the first data set in the least effective to date data set memory with the second data set;

storing in the decreased effectiveness lookup table data regarding the second data set; and

associating data regarding the adjusted system parameters with the second data set.

3. 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

if at least one value of the third data set is closer to the target value than a corresponding at least one value stored in the most effective to date data set memory;

replacing the data set in the most effective to date data set memory with the third data set; and

storing in the increased effectiveness lookup table data regarding the third data set and associating data regarding the further adjusted system parameters with the third data set.

4. The method of claim 2, 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

if at least one value of the fourth data set is not closer to the target value than a corresponding at least one value stored in the least effective to date data set memory;

replacing the data set in the least effective to date data set memory with the fourth data set; and

storing in the decreased effectiveness lookup table data regarding the fourth data set and associating data regarding the further adjusted system parameters with the fourth data set.

5. 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

adjusting the system parameters 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 the fifth data set.

6. 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.

7. The method of claim 1, wherein the at least one of the one or more patient parameters are selected from the group consisting of blood pressure, heart rate, pH and concentration of an electrolyte.

8. The method of claim 7, wherein the electrolyte is potassium.

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

10. A blood fluid removal system, comprising:

a blood fluid removal medium configured to remove blood from a patient, wherein blood enters the medium, fluid is removed from the blood, and blood exits the medium;

one or more control elements configured to control (i) the rate at which the medium removed fluid from the blood or (ii) the concentration of electrolytes or pH in the blood that exits the medium;

one or more sensors configured monitor one or more physiological parameter of the patient; and

control electronics comprising memory and a processor, wherein the control electronics are in operable communication with the one or more sensors and are operably coupled to the one or more control elements,

wherein the control electronics are configured to carry out a method according to claim 1.

11. The system of claim 10, wherein the blood fluid removal medium and the control electronics are housed within a blood fluid removal device.

12. The system of claim 10, further comprising a computer readable, wherein the computer readable medium comprises instructions that cause the control electronics to carry out the method.

13. A blood fluid removal system comprising:

a blood fluid removal medium configured to remove blood from a patient, wherein blood enters the medium, fluid is removed from the blood, and blood exits the medium;

one or more control elements configured to control (i) the rate at which the medium removed fluid from the blood or (ii) the concentration of electrolytes or pH in the blood that exits the medium;

one or more sensors configured monitor one or more physiological parameter of the patient; and

control electronics comprising memory and a processor, wherein the control electronics are in operable communication with the one or more sensors and are operably coupled to the one or more control elements,

wherein the control electronics are configured to (i) initiate a blood fluid removal session with initial system parameters;

(ii) acquire a first set of data regarding one or more patient physiological parameters;

(iii) store the first data set in a most effective to date data set memory;

(iv) associate the initial system parameters in an increased effectiveness lookup table with the first data set;

(v) adjust at least one parameter of the blood fluid removal session to arrive at adjusted system parameters;

(vi) 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

(vii) if at least one value of the second data set is closer to the target value than a corresponding at least one value of the first data set;

replace the first data set in the most effective to date data set memory with the second data set;

store in the increased effectiveness lookup table data regarding the second data set; and

associate data regarding the adjusted system parameters with the second data set.

14. A 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;

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 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

if a at least one value of the second data set is closer to the target value than a corresponding at least one value of the first data set;

replace the first data set in the most effective to date data set memory with the second data set;

store in the increased effectiveness lookup table data regarding the second data set; and

associate data regarding the adjusted system parameters with the second data set.

15. A method carried out by a blood fluid removal system, comprising:

collecting first data regarding a patient, the data including one or more of a physiological parameter and time since last blood fluid removal session;

collecting second data regarding system parameters employed in blood fluid removal sessions of the patient;

determining, based on the first and second collected data, whether at least one physiological parameter of the patient improved as a result of the system parameters employed;

determining whether a value of current patient data is within a predetermined range of a corresponding value of first collected data; and

employing the system parameters that resulted in improvement, if such parameters are determined to exist and if the current patient data is determined to be within the predetermined range.

16. A blood fluid removal system, comprising:

a blood fluid removal medium configured to remove blood from a patient, wherein blood enters the medium, fluid is removed from the blood, and blood exits the medium;

one or more control elements configured to control (i) the rate at which the medium removed fluid from the blood or (ii) the concentration of electrolytes or pH in the blood that exits the medium;

one or more sensors configured monitor one or more physiological parameter of the patient;

an input configured to allow entry of data regarding patient or system parameters; and

control electronics comprising memory and a processor, wherein the control electronics are in operable communication with the one or more sensors and are operably coupled to the one or more control elements and the input,

wherein the control electronics are configured to carry out a method according to claim 15.

17. The system of claim 16, wherein the blood fluid removal medium and the control electronics are housed within a blood fluid removal device.

18. The system of claim 16, further comprising a computer readable, wherein the computer readable medium comprises instructions that cause the control electronics to carry out the method.

19. A blood fluid removal system comprising:

a blood fluid removal medium configured to remove blood from a patient, wherein blood enters the medium, fluid is removed from the blood, and blood exits the medium;

one or more control elements configured to control (i) the rate at which the medium removed fluid from the blood or (ii) the concentration of electrolytes or pH in the blood that exits the medium;

one or more sensors configured monitor one or more physiological parameter of the patient;

an input configured to allow entry of data regarding patient or system parameters; and

control electronics comprising memory and a processor, wherein the control electronics are in operable communication with the one or more sensors and are operably coupled to the one or more control elements and the input,

wherein the control electronics are configured to;

collect first data regarding a patient, the data including one or more of a physiological parameter and time since last blood fluid removal session;

collect second data regarding system parameters employed in blood fluid removal sessions of the patient;

determine, based on the first and second collected data, whether at least one physiological parameter of the patient improved as a result of the system parameters employed;

determine whether a value of current patient data is within a predetermined range of a corresponding value of first collected data; and

employ the system parameters that resulted in improvement, if such parameters are determined to exist and if the current patient data is determined to be within the predetermined range.

20. A computer-readable medium comprising instructions that, when executed by a blood fluid removal device, cause the device to

collect first data regarding a patient, the data including one or more of a physiological parameter and time since last blood fluid removal session;

collect second data regarding system parameters employed in blood fluid removal sessions of the patient;

determine, based on the first and second collected data, whether at least one physiological parameter of the patient improved as a result of the system parameters employed;

determine whether a value of current patient data is within a predetermined range of a corresponding value of first collected data; and

employ the system parameters that resulted in improvement, if such parameters are determined to exist and if the current patient data is determined to be within the predetermined range.