Precision blood fluid removal therapy based on patient monitoring

• US 10,064,985 B2
• Filed: 12/20/2016
• Issued: 09/04/2018
• Est. Priority Date: 04/29/2011
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Lyu, Suping, Pudil, Bryant
• Primary Examiner(s): BREWSTER, HAYDEN R
• Application Number:
  US15/384,912
• Publication Number:
  US 20170100529A1
• Time in Patent Office: 623 Days
• Field of Search: 210 962, 210143, 210645, 210646, 210647, 210739, 600300, 600309, 600483, 600485, 600508, 604 609, 604 65, 604503, 718100
• 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 patent parameters. By comparing the patient'"'"'s current parameters to past parameters in response 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 non-transitory computer-readable storage medium with an executable program stored thereon comprising instructions that, when executed by one or more programmable computer systems incorporated into a blood fluid removal device, cause the blood fluid removal device to execute the following steps:

acquire first patient data of a first blood fluid removal session regarding one or more of (i) one or more patient physiological parameters; and

(ii) time since a last blood fluid removal session before an upcoming blood fluid removal session;

acquire data regarding one or more target outcomes of each blood fluid removal session;

compare the data regarding the at least one of the target outcomes of each blood fluid removal session to corresponding data regarding at least one prior patient outcome stored in a lookup table;

wherein the lookup table comprises data regarding system parameters used in the one or more prior blood fluid removal sessions of the patient and comprises prior patient data prior to a first session regarding one or more of (i) one or more patient physiological parameters and (ii) time since the prior blood fluid removal session before a corresponding upcoming blood fluid removal session;

compare the first patient data to the corresponding prior patient data stored in the lookup table;

initiate the upcoming blood fluid removal session employing the system parameters used in the prior blood fluid removal session if the at least one of the one or more target outcomes is within a predetermined range of the corresponding data regarding the at least one prior patient outcome stored in the lookup table and the patient data is within a predetermined range of the corresponding prior patient data.

2. A method carried out by a blood fluid removal system,

wherein the blood fluid removal system comprises:

(a) a blood fluid removal medium to remove blood from the patient, wherein the blood enters the medium, a fluid contained in the blood is removed from the blood, and the blood exits the medium;

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

(c) one or more sensors to monitor one or more physiological parameters of the patient wherein the physiological parameters are one or more selected from the group consisting of blood pressure, heart rate, pH, and electrolyte concentration, the one or more sensors sensing signals from one or more of the blood and a tissue of the patient; and

(d) 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 programmed to carry out the method, comprising;

acquiring first patient data of a first blood fluid removal session regarding one or more of;

(i) the one or more patient physiological parameters; and

(ii) time since a last blood fluid removal session before an upcoming blood fluid removal session;

acquiring data regarding one or more target outcomes of each blood fluid removal session;

comparing the data regarding at least one of the one or more target outcomes of each blood fluid removal session to corresponding data regarding at least one prior patient outcome stored in a lookup table, wherein the lookup table comprises data regarding system parameters used in the one or more prior blood fluid removal sessions of the patient and comprises prior patient data prior to the first session regarding one or more of (i) one or more patient physiological parameters; and

(ii) time since the prior blood fluid removal session before a corresponding upcoming blood fluid removal session;

comparing the first patient data to the corresponding prior patient data stored in the lookup table;

initiating the upcoming blood fluid removal session employing the system parameters used in the prior blood fluid removal session if the at least one of the one or more target outcomes is within a predetermined range of the corresponding data regarding the at least one prior patient outcome stored in the lookup table and the patient data is within a predetermined range of the corresponding prior patient data stored in the lookup table.

3. The method of claim 2, wherein the at least one of the one or more patient parameters comprise the concentration of an electrolyte.

4. The method of claim 3, wherein the electrolyte is potassium.

5. The method of claim 2, wherein the system parameters comprise one or more of fluid removal rate and concentration of one or more electrolyte.

6. 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 programmed to carry out a method according to claim 2.

7. The system of claim 6, wherein the blood fluid removal medium and the control electronics are housed within a blood fluid removal device.

8. The system of claim 6, further comprising a computer readable, wherein the computer readable medium comprises instructions that cause the control electronics to carry out the method according claim 2.

9. 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 programmed to;

acquire data regarding one or more of;

one or more patient physiological parameters; and

time since last blood fluid removal session;

acquire data regarding one or more target outcomes of a blood fluid removal session;

compare the data regarding at least one of the one or more target outcomes of the blood fluid removal session to corresponding data regarding at least one prior patient outcome stored in a lookup table, wherein the lookup table comprises data regarding system parameters used in one or more prior blood fluid removal sessions of the patient and comprises patient data prior to the previous session regarding one or more of (i) one or more patient physiological parameters; and

(ii) time since last blood fluid removal session;

compare the data regarding the one or more of (i) one or more patient physiological parameters; and

(ii) time since last blood fluid removal session to corresponding patient data prior to the previous session stored in the lookup table; and

initiate a blood fluid removal session employing the system parameters used the prior blood fluid removal session if the at least one of the one or more target outcomes is within a predetermined range of the corresponding data regarding the at least one prior target outcome stored in the lookup table and the data regarding the one or more of (i) one or more patient physiological parameters; and

(ii) time since last blood fluid removal session is within a predetermined range of the corresponding patient data prior to the previous session stored in the lookup table.

10. A non-transitory computer-readable storage medium with an executable program stored thereon comprising instructions that, when executed by one or more programmable computer systems incorporated into a blood fluid removal device, cause the blood fluid removal device to execute the following steps:

acquire first patient data of a first blood fluid removal session regarding one or more of;

(i) one or more patient physiological parameters; and

(ii) time since last blood fluid removal session;

acquire data regarding one or more target outcomes of each blood fluid removal session;

compare the data regarding at least one of the one or more target outcomes of each blood fluid removal session to corresponding data regarding at least one prior patient outcome stored in a lookup table, wherein the lookup table comprises data regarding system parameters used in the one or more prior blood fluid removal sessions of the patient and comprises prior patient data prior to the first session regarding one or more of (i) one or more patient physiological parameters; and

(ii) time since the prior blood fluid removal session;

compare the first patient data to the corresponding prior patient data stored in the lookup table; and

initiate the upcoming blood fluid removal session employing the system parameters used in the prior blood fluid removal session if the at least one of the one or more target outcomes is within a predetermined range of the corresponding data regarding the at least one prior target outcome stored in the lookup table and the patient data is within a predetermined range of the corresponding prior patient data stored in the lookup table.