Cardiovascular monitoring for fluid removal processes

Patent metadata

Field	Value
Publication number	US-9061099-B2
Application number	US-201213424490-A
Country	US
Kind code	B2
Filing date	Mar 20, 2012
Priority date	Apr 29, 2011
Publication date	Jun 23, 2015
Grant date	Jun 23, 2015

Abstract

A method includes initiating a blood fluid removal session for a patient in need thereof; monitoring a cardiovascular parameter of the patient; determining whether the indicator of the cardiovascular state crosses a predetermined threshold; and altering a parameter of the blood fluid removal session if the indicator is determined have crossed the threshold.

First claim

What is claimed is:

1. A method carried out by a blood fluid removal device or system, comprising:
initiating a blood fluid removal session for a patient in need thereof;
monitoring a cardiovascular parameter and at least one additional physiological parameter of the patient with at least one sensor;
determining whether an indicator of the cardiovascular parameter or physiological parameter crosses a predetermined threshold; and
altering a parameter of the blood fluid removal session if the indicator is determined to have crossed the threshold,
wherein the blood fluid removal device comprises control electronics, wherein the control electronics are configured to control one or more flow control elements to adjust a pH or electrolyte concentration of a replacement fluid based on the data from the at least one sensor; and
wherein altering a parameter of the blood fluid removal session comprises setting or adjusting the pH and electrolyte concentration of the replacement fluid based at least on the cardiovascular or physiological parameter of the patient wherein the step of altering the parameter of the blood fluid removal session is carried out by the blood fluid removal device.

2. The method of claim 1 , wherein the predetermined threshold is based on measurements of the cardiovascular parameter obtained prior to initiating the blood fluid removal session.

3. The method of claim 1 , further comprising monitoring the cardiovascular parameter of the patient prior to initiating the blood fluid removal session, and setting an initial prescription for the blood fluid removal session based on the cardiovascular parameter monitored prior to initiating the blood fluid removal session.

4. The method of claim 3 , wherein setting the initial prescription for the blood fluid removal session comprises setting a fluid removal prescription or setting a dialysate composition prescription.

5. The method of claim 4 , wherein monitoring the cardiovascular parameter of the patient prior to initiating the blood fluid removal session comprises chronically monitoring the cardiovascular parameter.

6. The method of claim 5 , further comprising (i) determining whether the cardiovascular parameter crosses a predetermined threshold, and (ii) scheduling the blood fluid removal session or providing an alert if the parameter crosses the threshold.

7. The method of claim 1 , wherein monitoring the cardiovascular parameter comprises monitoring one or more of heart rate, heart rhythm or blood pressure.

8. The method of claim 1 , wherein altering the parameter of the blood fluid removal session comprises altering the rate of removal of fluid from the patient's blood.

9. The method of claim 1 , wherein altering the parameter of the blood fluid removal session comprises altering a concentration of a component of a fluid selected from dialysate or replacement fluid.

10. A method carried out by a blood fluid removal device or system, comprising:
receiving data regarding a monitored cardiovascular parameter and at least one additional physiological parameter to a blood fluid removal device or system; wherein
the blood fluid removal device comprises control electronics, wherein the control electronics are configured to control one or more flow control elements to adjust a pH or electrolyte concentration of a replacement fluid based on the data from the at least one sensor; and
setting a parameter for a blood fluid removal session based on the received data regarding the monitored cardiovascular or physiological parameter, wherein the parameter for the blood fluid removal session is set by control electronics of a blood fluid removal device or system,
wherein setting the parameter for the blood fluid removal session comprises setting or adjusting the pH and electrolyte concentration of a replacement fluid based at least on the monitored physiological parameter, and wherein setting the parameter for the blood fluid removal session is carried out by the blood fluid removal device.

11. The method of claim 10 , wherein the cardiovascular and at least one physiological parameter of the patient are used in setting an initial prescription for the blood fluid removal session, wherein setting an initial prescription for the blood fluid removal session comprises setting a fluid volume removal prescription.

12. The method of claim 10 , wherein setting an initial prescription for the blood fluid removal session comprises setting a dialysate composition or a replacement fluid composition.

13. The method of claim 10 , wherein the cardiovascular parameter comprises one or more of heart rate, heart rhythm and blood pressure.

14. A system comprising:
a blood fluid removal device comprising
(i) an inlet for receiving blood from a patient,
(ii) an outlet for returning blood to the patient,
(iii) a medium for removing fluid and contaminants from the blood, the medium being positioned between the inlet and the outlet, and
(iv) a control element for controlling the rate at which fluid is removed from the blood by the medium;
a sensor for monitoring a cardiovascular parameter and at least one additional physiological parameter of the patient; and
control electronics in operable communication with the sensor and the control element, wherein the control electronics are configured, via the control element, to adjust the rate at which the fluid is removed from the blood,
and wherein the pH and electrolyte concentration of a replacement fluid can be set or adjusted based at least on a cardiovascular or physiological parameter of the patient by the blood fluid removal device.

15. The system of claim 14 , wherein the blood fluid removal device further comprises a fluid source for carrying a system fluid, the system fluid selected from dialysate and replacement fluid, wherein if the fluid is dialysate the fluid source carries the fluid to the medium, and wherein if the fluid is replacement fluid the fluid source carries the fluid to the blood after the blood exits the medium; wherein the system further comprises
a concentrate source for housing a concentrate solution comprising a concentrated component for the system fluid; and
a concentrate flow control element for controlling the rate at which the concentrate solution enters the fluid source;
wherein the sensor is operably coupled to the control electronics and the control electronics are further configured, via the concentrate flow control element, to adjust the rate at which the concentrate solution enters the fluid source based on data obtained from the sensor.

16. The system of claim 14 , wherein the control electronics are housed within the blood fluid removal device.

17. A system comprising:
a blood fluid removal device comprising
(i) an inlet for receiving blood from a patient,
(ii) an outlet for returning blood to the patient,
(iii) a medium for removing fluid and contaminants from the blood, the medium being positioned between the inlet and the outlet, and
(iv) a fluid source for carrying a fluid, the fluid selected from dialysate and replacement fluid, wherein if the fluid is dialysate the fluid source carries the fluid to the medium, and wherein if the fluid is replacement fluid the fluid source carries the fluid to the blood after the blood exits the medium;
a concentrate source for housing a concentrate solution comprising a concentrated component for the fluid;
a concentrate flow control element for controlling the rate at which the concentrate solution enters the fluid source;
a sensor for monitoring a cardiovascular parameter and at least one additional

Assignees

• Gerber Martin
• Burnes John
• Lyu Suping
• Venkatesh Manda R
• Pudil Bryant
• Medtronic Inc

Inventors

• Gerber Martin
• Burnes John
• Lyu Suping
• Venkatesh Manda R
• Pudil Bryant

Classifications

• A61M2205/3375

  Acoustical, e.g. ultrasonic, measuring means · CPC title

• A61M2205/18

  with alarm · CPC title

• A61M2230/005

  Parameter used as control input for the apparatus · CPC title

• A61M2205/3306

  Optical measuring means · CPC title

• A61M2205/3313

  used specific wavelengths · CPC title