Blood fluid removal system performance monitoring

Patent metadata

Field	Value
Publication number	US-2016206801-A1
Application number	US-201615067559-A
Country	US
Kind code	A1
Filing date	Mar 11, 2016
Priority date	Apr 29, 2011
Publication date	Jul 21, 2016
Grant date	—

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 medium 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 or fluid flow 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 . A blood fluid removal system comprising:
a medium 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; 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 minor chamber.

3 . The blood fluid removal system of claim 2 , wherein the control electronics are further configured to acquire data from the one or more sensors and to determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data at a predetermined amount of time after the dialysate flow rate is increased.

4 . The blood fluid removal system of claim 2 , wherein the control electronics configured (i) adjust the one or more system parameters back to the original setting at a predetermined time after the system parameters are adjusted, and (ii) to acquire data from the one or more sensors after the dialysate rate has been reduced and to determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data after the one or more system parameters are adjusted back to the original setting.

5 . The blood fluid removal system of claim 2 , further comprising:
a computer-readable medium comprising instructions that, when implemented, cause the control electronics (i) to acquire data from the one or more sensors, (ii) determine whether the membrane is functioning within a first predefined range of parameters based on the acquired data; and (iii) adjust the dialysate flow rate through the second minor chamber from an original dialysate flow rate, via control of the dialysate flow controller, if the membrane is determined to not be function within the first range.

6 . A method for de-fouling a membrane of a blood fluid removal system, the system comprising (i) a medium housing defining a major chamber; (ii) a blood fluid removal membrane disposed into the media housing and sealingly dividing the major chamber into first and second minor chambers; (iii) 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; (iv) 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; (v) one or more sensors configured to measure a pressure differential across the membrane; (vi) a dialysate flow controller configured to control the rate of dialysate flow rate through the second minor chamber; and (vii) control electronics operably coupled to the one or more sensors and to the dialysate flow controller, the method carried out by the control electronics of the system and comprising:
acquiring data from the one or more sensors; determining whether the membrane is functioning within a first predefined range of parameters based on the acquired data; and adjusting one or more system parameters from an original setting if the membrane is determined to not be functioning within the first range, wherein the adjusting one or more system parameters is selected from the group consisting 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.

7 . The method of claim 6 , further comprising:
acquiring data from the one or more sensors; and determining whether the membrane is functioning within a first predefined range of parameters based on the acquired data at a predetermined amount of time after the one or more system parameters are adjusted.

8 . The method of claim 6 , further comprising:
adjusting the one or more system parameters back to the original setting at a predetermined time after the flow rate is increased; acquiring data from the one or more sensors after the one or more system parameters are adjusted back to the original setting; and determining whether the membrane is functioning within a first predefined range of parameters based on the acquired data after the one or more system parameters are adjusted back to the original setting.

9 . A method comprising:
monitoring rate of flow of blood, or an indicator thereof, entering the blood fluid removal device of claim 1 ; determining whether the monitor

Assignees

• Medtronic Inc

Inventors

• Gerber Martin
• Lyu Suping
• Pudil Bryant

Classifications

• A61B5/4848

  Monitoring or testing the effects of treatment, e.g. of medication · CPC title

• B01D2321/12

  Use of permeate · CPC title

• A61M1/00

  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 title

• B01D2321/40

  Automatic control of cleaning processes · CPC title

• A61B5/14546

  for measuring analytes not otherwise provided for, e.g. ions, cytochromes · CPC title