Systems and methods for multifunctional volumetric fluid control

• US 10,532,141 B2
• Filed: 12/13/2017
• Issued: 01/14/2020
• Est. Priority Date: 02/01/2013
• Status: Active Grant

• Current Assignee: Mozarc Medical US LLC
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Meyer, Thomas E., Lura, David B., Pudil, Bryant J., Gerber, Martin T.
• Primary Examiner(s): Spies, Bradley R
• Application Number:
  US15/840,102
• Publication Number:
  US 20180099079A1
• Time in Patent Office: 762 Days
• Field of Search: None
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/154 with sensing means or components thereof
• CPC Class Codes: A61M 1/1562 Details of incorporated reservoirs
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1605 Physical characteristics of the dialysate fluid
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• CPC Class Codes: A61M 1/1652 Holding or locking systems for the membrane unit
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/1664 with temperature control
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1676 containing proteins, e.g. albumin
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3437 : downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/362262 : Details of incorporated reservoirs
• CPC Class Codes: A61M 1/362264 : the filter being a blood filter
• CPC Class Codes: A61M 1/362266 : Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3643 : Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 : Mode of operation
• CPC Class Codes: A61M 1/3649 : using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• 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 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2209/06 : Packaging for specific medical equipment
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity

Abstract

Systems and methods for controlling fluid movement and volumes of fluid between a subject and a controlled compliant flow path. The controlled compliant flow path has a means for selectively metering in and metering out fluid from the controlled compliant flow path. An extracorporeal flow path is in fluid communication with the controlled compliant flow path across a semi-permeable membrane where the extracorporeal flow path has a first terminal end and a second terminal end.

Claims

1. A system for performing any one of hemodialysis, hemodiafiltration, hemofiltration, comprising:

a controlled compliant flow path comprising a dialyzer;

at least a first pump in fluid communication with the controlled compliant flow path;

a common reservoir in fluid communication with the first pump, wherein the common reservoir contains any one of a dialysate, a filtrate, a volume of a physiologically compatible priming solution, a volume of a physiologically compatible solution to provide a bolus of fluid to a subject receiving treatment, a volume of physiologically compatible solution to provide solution for return of blood from an extracorporeal flow path to a subject receiving treatment, a volume of solution returned to the common reservoir from an extracorporeal flow path when blood from a subject is introduced to the extracorporeal flow path, and combinations thereof;

the at least first pump for selectively metering in and/or metering out fluid from the controlled compliant flow path;

the at least first pump operable to control net fluid movement into and/or out of the controlled compliant flow path, wherein the at least first pump is operated by a controller applying an instantaneous rate of fluid removal to a control algorithm;

at least one conductivity sensor in the controlled compliant flow path;

the controller controlling a water pump, a salination pump, or combinations thereof, to control dialysate conductivity based on data received from the at least one conductivity sensor.

2. The system of claim 1, wherein the controller applies the control algorithm to obtain a net volume of fluid added to and/or removed from a patient during therapy by an equation:

Σ

_i=0ⁿX_i=patient fluid balance;

wherein n is a number of pumps fluidly connected to the controlled compliant flow path, i refers to a specific pump fluidly connected to the controlled compliant flow path, and X_i is volumetric flow rate of a pump in either an influx or efflux direction;

wherein is negative when pump i is operated in the efflux direction and positive when pump i is operated in an influx direction.

3. The system of claim 2, wherein the number of pumps includes at least one selected from a water pump, an acid concentrate pump, a salination pump, a replacement fluid pump, and combinations thereof.

4. The system of claim 3, the controller controlling applying an instantaneous rate of fluid removal to a control algorithm for each pump.

5. The system of claim 1, wherein the controlled compliant flow path has a substantially inflexible volume.

6. The system of claim 1, further comprising at least second pump that operates in a single direction to meter a controlled volume of a first fluid from the controlled compliant flow path and to return an equal volume of a second fluid to the controlled compliant flow path.

7. The system of claim 6, wherein the second fluid contains a saline concentration different from the first fluid.

8. The system of claim 1, wherein the extracorporeal flow path has a blood pump for circulating blood through the extracorporeal flow path, and a first valve and/or a second valve to selectively permit flow through a first conduit and a second conduit in fluid communication across either a dialyzer or hemofilter on the extracorporeal flow path.

9. The system of claim 8, further comprising a first valve and/or a second valve, wherein at least the at least one pump coordinately operates with the first valve and/or a second valve to control fluid movement.

10. The system of claim 9, wherein the at least one pump and the blood pump on the extracorporeal flow path coordinately operate with the first valve and/or second valve to control fluid movement.

11. The system of claim 1, further comprising a microbial filter on the controlled compliant flow path wherein fluid passes through the microbial filter prior to crossing the dialyzer.

12. The system of claim 1, further comprising a microbial filter on the controlled compliant flow path wherein fluid passes through the microbial filter prior to entering the extracorporeal flow path.

13. The system of claim 1, wherein a volumetric flow rate of the water pump, salination pump, or combination thereof is included in the control algorithm.

14. The system of claim 13, wherein the salination pump is in communication with a sodium chloride source, a buffer source, or combinations thereof.

15. The system of claim 14, wherein the sodium chloride source is a sodium chloride cartridge that can increase a sodium chloride concentration of fluid passing through the sodium chloride cartridge and wherein the buffer source is a buffer source cartridge that can increase a buffer concentration of fluid passing through the buffer source cartridge.

16. The system of claim 14, wherein the salination pump, sodium chloride source, and buffer source are positioned on a conditioning pathway, the conditioning pathway having an inlet and an outlet fluidly connected to the controlled compliant flow path.

17. The system of claim 1, the controller determining a net fluid removal during an elapsed therapy time by integrating the instantaneous rate of fluid removal over a time course of therapy.

18. The system of claim 1, the controller operating the at least one pump to accomplish a predetermined patient fluid balance at any time throughout a course of a therapy delivery session.