Monitoring fluid volume for patients with renal disease

• US 9,642,960 B2
• Filed: 11/26/2014
• Issued: 05/09/2017
• 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, VenKatesh, Manda R., Pudil, Bryant
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/554,272
• Publication Number:
  US 20150088047A1
• Time in Patent Office: 895 Days
• Field of Search: 604 501, 604 504, 604 609, 604 611, 210645, 210646, 210746
• 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

A method includes monitoring an indicator of fluid volume of a patient via a sensor device, and setting an initial fluid volume removal prescription for a blood fluid removal session based on the monitored indicator of fluid volume. The method may further include transmitting data regarding the indicator of fluid volume from the implantable sensor device to fluid removal device. The system includes a blood fluid removal device configured to set the initial fluid removal volume and rate prescription. In some embodiments, the fluid removal device sets or calculated the initial fluid volume removal prescription based on the data received from the implantable sensor. The indicator of fluid volume may be an indicator of tissue fluid volume or an indicator of blood fluid volume.

Claims

1. A system comprising:

a first sensor configured to monitor an indicator of tissue fluid volume;

a second sensor configured to monitor an indicator of blood fluid volume; and

a blood fluid removal device comprising

(i) an inlet for receiving blood from a patient,

(ii) an first outlet for returning blood from the patient,

(iii) a medium for removing fluid from the blood, the medium being positioned between the inlet and the first outlet,

(iv) a fluid rate removal controller,

(v) a second outlet for flow of the removed fluid, and

(vi) electronics coupled to the fluid rate removal controller and the sensor,

wherein the electronics are configured to set an initial fluid rate removal prescription based on data received from the first sensor configured to monitor an indicator of tissue fluid volume and the second sensor configured to monitor an indicator of blood fluid volume by setting the initial fluid volume removal prescription based on the monitored indicator of tissue fluid volume and the monitored indicator of blood fluid volume and sending an instruction to adjust the fluid removal rate to the fluid rate removal controller.

2. The system of claim 1, wherein the first or second sensor is implantable.

3. The system of claim 1, wherein the first or second sensor is wearable.

4. The system of claim 1, wherein the electronics comprise a computer readable medium that, when implemented, cause the electronics to calculate the initial fluid rate removal prescription based on data received from the first and second sensors and instruct the fluid rate removal controller to operate according to the initial fluid rate removal prescription.

5. The system of claim 1, wherein the any one or both of the first and second sensor and the fluid removal device are implantable.

6. The system of claim 1, wherein the first or second sensor and the fluid removal device are wearable.

7. The system of claim 1, wherein the control electronics are disposed in a housing of the blood fluid removal device.

8. The system of claim 1, wherein the first or second sensor is configured to measure one or more of tissue impedance, blood hematocrit, and hemoglobin levels.

9. The system of claim 1, wherein the first or second sensor is configured to measure impedance, and wherein the first or second sensor comprises a first electrode and a second electrode.

10. The system of claim 9, further comprising a third sensor configured to measure impedance, wherein the third sensor senses impedance in a location different from the first or second sensor.

11. The system of claim 10, wherein the first sensor, second sensor, and the third sensor are in electronic communication, and wherein the electronics are configured to determine if the impedance measured by the first sensor and the impedance measured, by the second sensor, or by the third sensor differ by a pre-determined amount.

12. The system of claim 1, further comprising a medium for introducing replacement fluid into the blood.

13. The system of claim 12, further comprising a replacement fluid rate controller configured to control the rate of fluid introduction into the blood, and electronics coupled to the replacement fluid rate controller and the first or second sensor, wherein the electronics are configured to set an initial replacement fluid rate prescription based on data received from the first or second sensor and to control the replacement fluid rate controller based on the set initial fluid rate removal prescription.

14. The system of claim 13, wherein the replacement fluid is added to the blood before the blood enters the blood fluid removal device.

15. The system of claim 13, wherein the replacement fluid is added to the blood after the blood exits the blood fluid removal device.

16. The system of claim 1, wherein the electronics are further configured to set an initial fluid volume removal prescription.

17. The system of claim 1, wherein the first or second sensor is configured to transmit the monitored indicator to an external device.

18. The system of claim 17, wherein the external device is one or more of the group consisting of a programmer, a computer, a personal data assistant, and a tablet.

19. The system of claim 1, further comprising an alert mechanism, the alert mechanism configured to provide an alert if the monitored indicator exceeds a predetermined threshold.

20. The system of claim 1, wherein the electronics are configured to set the initial fluid rate removal prescription based on a ratio of the indicator of tissue fluid volume to the indicator of blood fluid volume.