Blood fluid removal system performance monitoring

Patent metadata

Field	Value
Publication number	US-10406268-B2
Application number	US-201615067559-A
Country	US
Kind code	B2
Filing date	Mar 11, 2016
Priority date	Apr 29, 2011
Publication date	Sep 10, 2019
Grant date	Sep 10, 2019

Abstract

Monitoring of the performance of a blood fluid removal medium of a blood fluid removal device includes monitoring of condition, such as fluid flow rate or concentration of blood waste product, downstream of the medium. Upstream monitoring of the condition may also be performed to enhance the ability to determine whether the blood fluid removal medium is performing within predetermined ranges.

First claim

We claim:

1. A blood fluid removal system comprising:
a media housing defining a major chamber;
a blood fluid removal membrane disposed into the media housing and sealingly dividing the major chamber into first and second minor chambers;
a first inlet and a first outlet in fluid communication with the first minor chamber, wherein the system is configured such that blood enters the first minor chamber through the first inlet and exits the first minor chamber though the first outlet;
a second outlet in fluid communication with the second minor chamber, wherein the system is configured such that fluid removed from the blood exits the second minor chamber through the second outlet;
a first sensor configured to detect an indicator of a blood waste product at or downstream of the second outlet;
control electronics configured to acquire data from the sensor and configured to determine whether the membrane is functioning within predetermined parameters based on the acquired data; and further comprising:
(i) a second inlet in communication with the second minor chamber, wherein dialysate is configured to flow through the second inlet and the second outlet; and (ii) a dialysate flow controller operably coupled to the control electronics, wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics are configured to adjust one or more system parameters selected from the group of: adjusting a dialysate flow rate via the dialysate flow controller, adjusting a blood flow rate via a blood flow control element, and adjusting a pressure differential between the first minor chamber and the second minor chamber.

2. The blood fluid removal system of claim 1 , wherein the control electronics are further configured to acquire data from the sensor at a predetermined time after the system parameters are adjusted, and to determine whether the membrane is functioning within predetermined parameters based on the acquired data at the predetermined amount of time after the system parameters are adjusted.

3. The blood fluid removal system of claim 1 , further comprising a second sensor configured to detect the indicator of a blood waste product at or upstream of the second inlet, wherein the control electronics are configured to acquire data from the second sensor, and wherein the control electronics are configured to compare data acquired from the first sensor to data acquired from the second sensor in determining whether the membrane is functioning within predetermined parameters.

4. The blood fluid removal system of claim 1 , further comprising a second sensor configured to detect the indicator of a blood waste product at or upstream of the first inlet, wherein the control electronics are configured to acquire data from the second sensor, and wherein the control electronics are configured to compare data acquired from the first sensor to data acquired from the second sensor in determining whether the membrane is functioning within predetermined parameters.

5. The blood fluid removal system of claim 1 , wherein the control electronics are configured to acquire data from the sensor at a first time and at a second time later than the first time, and wherein the control electronics are configured to compare data from the first sensor at the first time and second time in determining whether the membrane is functioning within predetermined parameters.

6. The blood fluid removal system of claim 1 , wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics are further configured to determine whether the data from the first sensor is indicative of clotting, and to increase an amount of anticoagulants added to the blood or dialysate if the data from the sensor is indicative of clotting.

7. The blood fluid removal system of claim 1 , wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics determine whether the data from the first sensor is indicative of protein deposition.

8. A method comprising:
monitoring rate of flow of blood, or an indicator thereof, entering the blood fluid removal system of claim 1 ;
determining whether the monitored flow rate or indicator is within a predetermined range; and
adjusting a system parameter of the blood fluid removal system or a blood fluid removal session parameter if the monitored flow rate or indicator is not within the predetermined range.

9. The method of claim 8 , wherein the blood fluid removal system comprises a blood flow control element configured to control the rate of flow of blood through the system and wherein adjusting a system parameter comprises adjusting a parameter of a blood flow control element to adjust the rate of flow of blood through the system.

10. The method of claim 9 , further comprising:
monitoring rate of flow of blood, or an indicator thereof, through the blood fluid removal system; and
determining whether the monitored flow rate or indicator is within a predetermined range.

11. The method of claim 10 , wherein adjusting a system parameter comprises adjusting a parameter configured to control rate of fluid removal from the blood.

12. The method of claim 11 , wherein adjusting the parameter configured to control rate of fluid removal from the blood comprises adjusting the rate of flow of dialysate.

13. The method of claim 11 , wherein adjusting the parameter configured to control rate of fluid removal from the blood comprises adjusting a pressure differential across a media configured to remove fluid from the blood.

14. The method of claim 11 , wherein adjusting the session parameter comprises adjusting the length of time of the session.

15. A blood fluid removal system comprising:
a media housing defining a major chamber;
a blood fluid removal membrane disposed into the media housing and sealingly dividing the major chamber into first and second minor chambers;
a first inlet and a first outlet in fluid communication with the first minor chamber, wherein the system is configured such that blood enters the first minor chamber through the first inlet and exits the first minor chamber though the first outlet;
a second inlet and a second outlet in fluid communication with the second minor chamber, wherein the system is configured such that fluid removed from the blood exits the second minor chamber through the second outlet and such that dialysate flows through the second minor chamber from the second inlet to the second outlet;
one or more sensors configured to measure a pressure differential across the membrane;
control electronics configured to acquire data from the one or more sensors and configured to determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data; wherein, if the membrane is determined not to be functioning within the first predefined range of parameters, the control electronics determine whether the data from the one or more sensors is indicative of clotting or of protein deposition; and
a dialysate flow controller operably coupled to the control electronics, wherein, if the membrane is determined not to be functioning within predetermined limits, the control electronics are configured to adjust one or more system parameters from an original setting, wherein adjusting the one or more system parameters is selected from the group of: adjusting a dialysate flow rate via the dialysate flow controller, adjusting a blood flow rate via a blood flow control element, and adjusting a pressure differential between the first minor chamber and the second

Assignees

• Medtronic Inc

Inventors

• Gerber Martin
• Lyu Suping
• Pudil Bryant

Classifications

• A61B5/4836

  Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence) · CPC title

• A61M2205/04

  implanted · CPC title

• A61B5/0537

  Measuring body composition by impedance, e.g. tissue hydration or fat content · CPC title

• A61M2205/3523

  using telemetric means · CPC title

• A61B5/14503

  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 title