System and method to regulate ultrafiltration

• US 9,943,633 B2
• Filed: 06/23/2016
• Issued: 04/17/2018
• Est. Priority Date: 09/30/2009
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sigg, Daniel C., Audet, Sarah Anne, Bennett, Tommy D., Warkentin, Dwight H.
• Primary Examiner(s): Wiest, Philip R
• Application Number:
  US15/190,553
• Publication Number:
  US 20160331884A1
• Time in Patent Office: 663 Days
• CPC Class Codes: A61M 1/16 with membranes
• 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 1/3406 Physical characteristics of the filtrate, e.g. urea
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3669 Electrical impedance measurement of body fluids; transducers specially adapted therefor
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/33 Controlling, regulating or measuring
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3344 Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity

Abstract

A medical device system including a physiological sensor and ultrafiltration unit senses a physiological signal in a patient and computes a fluid status measurement of the patient using the physiological signal. Ultrafiltration therapy is delivered to the patient according to a therapy delivery control parameter established in response to the fluid status measurement.

Claims

1. A method for use in a medical device system comprising a physiological sensor and an ultrafiltration therapy delivery device, the method comprising:

sensing at least one physiological signal from an implanted medical device (IMD) in a patient;

computing a fluid status measurement of the patient using the at least one physiological signal;

delivering ultrafiltration therapy to the patient according to a therapy delivery control parameter; and

establishing a setting for the control parameter in response to the fluid status measurement;

wherein the at least one physiological parameter includes an ECG signal.

2. The method of claim 1, further comprising:

storing a target range of the fluid status measurement;

comparing the fluid status measurement to the target range; and

establishing the control parameter in response to the comparison.

3. The method of claim 2, further comprising determining a trend of previously computed fluid status measurements and computing the target range using the trend.

4. The method of claim 2, wherein establishing the control parameter comprises establishing a flow rate in proportion to a difference between the fluid status measurement and the target range.

5. The method of claim 4, wherein establishing a flow rate comprises controlling one or more valves to control the flow rate.

6. The method of claim 2, further comprising storing a target level of the fluid status measurement,

performing ultrafiltration until a current fluid status measurement reaches the target level.

7. The method of claim 2, further comprising sensing at least a second physiological signal in the patient;

wherein the first physiological signal and second physiological signal are different signals;

computing a second fluid status measurement of the patient using the second physiological signal; and

wherein the target range is an index computed using a combination of the at least two fluid status measurements.

8. The method of claim 1, further comprising storing a therapy delivery threshold;

comparing the fluid status measurement to the therapy delivery threshold and detecting a need for ultrafiltration therapy in response to the comparison;

enabling the ultrafiltration therapy delivery device in response to detecting the need.

9. The method of claim 1, further comprising:

computing an updated fluid status measurement during delivery of ultrafiltration therapy; and

determining an adjusted setting for the control parameter in response to the updated fluid status measurement.

10. The method of claim 9, further comprising stopping ultrafiltration therapy when the updated fluid status measurement is within a target range.

11. The method of claim 1, further comprising sensing at least a second physiological signal in the patient;

wherein the first physiological signal and second physiological signal are different signals;

computing a second fluid status measurement of the patient using the second physiological signal; and

wherein the step of establishing a setting for the control parameter in response to the fluid status measurement comprises establishing a setting for the control parameter in response to the first and second fluid status measurements.

12. The method of claim 11, wherein the second physiological signal is selected from the group consisting of intraventricular pressure, thoracic impedance, oxygen, blood urea nitrogen, serum creatine, serum electrolytes, blood glucose, thyroid stimulating hormone, intracardia right ventricular pressure signals, transthoracic signals, or any combination thereof.

13. The method of claim 1, wherein the control parameter is a setting which enables or disables ultrafiltration.

14. The method of claim 1, wherein the control parameter is pressure across an ultrafiltration membrane.

15. The method of claim 1, wherein the ultrafiltration therapy delivery device automatically delivers ultrafiltration therapy to the patient when the fluid status measurement is outside of a target range.

16. The method of claim 1, wherein the ultrafiltration therapy delivery device generates a notification when the fluid status measurement is outside of a target range.

17. The method of claim 1, further comprising a step of continuously decreasing or decreasing in small stepwise increments the control parameter, as the fluid status measurement improves.

18. A computer readable medium storing a set of instructions which cause a programmable processor implemented in a medical device system comprising a physiological sensor and an ultrafiltration unit to perform a method comprising:

sensing at least one physiological signal from an implanted medical device (IMD) in a patient;

computing a fluid status measurement of the patient using the physiological signal;

delivering ultrafiltration therapy to the patient according to a therapy delivery control parameter; and

establishing a setting for the control parameter in response to the fluid status measurement;

wherein the at least one physiological signal includes an ECG signal.

19. The computer readable medium of claim 18, wherein the method further comprises determining a trend of previously computed fluid status measurements and computing the target range using the trend.

20. The computer readable medium of claim 18, wherein the method further comprises sensing at least a second physiological signal of the patient;

computing a second fluid status measurement of the patient using the second physiological signal; and

wherein the step of establishing a setting for the control parameter in response to the fluid status measurement comprises establishing a setting for the control parameter in response to the first and second fluid status measurements.

21. The computer readable medium of claim 20, wherein the second physiological signal is selected from the group consisting of intraventricular pressure, thoracic impedance, oxygen, blood urea nitrogen, serum creatine, serum electrolytes, blood glucose, thyroid stimulating hormone, intracardia right ventricular pressure signals, transthoracic signals, or any combination thereof.