# US 9,872,949 B2 · Systems and methods for multifunctional volumetric fluid control

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- Number: US 9,872,949 B2
- Document ID: US9872949B2
- Status: Granted
- Kind: B2
- Application number: 15/449,015
- Filed: 2017-03-03
- Published: 2017-06-29
- Granted: 2018-01-23
- Earliest claimed: 2013-02-01
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Thomas E. Meyer; David B. Lura; Bryant J. Pudil; Martin T. Gerber
- Web page: https://patentgrep.com/patent/US9872949B2

## CPC

- 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)}
- A61M 1/1524: {the interface providing means for actuating on functional elements of the cassette, e.g. plungers}
- A61M 1/154: {with sensing means or components thereof}
- A61M 1/1562: {Details of incorporated reservoirs}
- A61M 1/15632: {the filter being a dialyser}
- A61M 1/16: with membranes
- A61M 1/1601: {Control or regulation}
- A61M 1/1605: {Physical characteristics of the dialysate fluid}
- A61M 1/1652: {Holding or locking systems for the membrane unit}
- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/1658: {Degasification}
- A61M 1/1664: {with temperature control}
- A61M 1/1666: {by dissolving solids}
- A61M 1/1668: {Details of containers}
- A61M 1/1672: {using membrane filters, e.g. for sterilising the dialysate}
- A61M 1/1676: {containing proteins, e.g. albumin}
- A61M 1/169: {using chemical substances}
- A61M 1/1696: {with dialysate regeneration}
- A61M 1/3413: {Diafiltration}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- A61M 1/3627: {Degassing devices; Buffer reservoirs; Drip chambers; Blood filters}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3644: {Mode of operation}
- A61M 1/3649: {using dialysate as priming or rinsing liquid}
- A61M 1/365: {through membranes, e.g. by inverted trans-membrane pressure [TMP]}
- A61M 1/165: {with a dialyser bypass on the dialysis fluid line}
- A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate}
- A61M 1/362262: {Details of incorporated reservoirs}
- A61M 1/362264: {the filter being a blood filter}
- A61M 1/362266: {Means for adding solutions or substances to the blood}
- A61M 1/3626: {Gas bubble detectors}
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3368: Temperature
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2209/06: Packaging for specific medical equipment
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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

### Claim 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;
at least a second pump in fluid communication with the controlled compliant flow path and either a fluid source or a reservoir; wherein the second pump is a water pump in fluid communication with a water source;
the at least first pump and at least second pump for selectively metering in and metering out fluid from the controlled compliant flow path;
at least one sensor measuring a sodium content of a fluid in the controlled compliant flow path;
a controller programmed to determine the sodium content of the fluid in the controlled compliant flow path and to control the second pump based at least in part on the sodium content of the fluid in the controlled compliant flow path;
the at least first pump and at least second pump operable in concert to control net fluid movement into and out of the controlled compliant flow path, wherein the at least first pump and at least second pump are coordinately operated by the controller applying an instantaneous rate of fluid removal to a control algorithm.

### Claim 2 (depends on 1)

The system of claim 1, further comprising at least one pump selected from the group consisting of, an acid concentrate pump, a salination pump, a replacement fluid pump, and combinations thereof.

### Claim 3 (depends on 1)

The system of claim 1, wherein the controller applies the control algorithm to obtain the net volume of fluid added to and/or removed from a patient during therapy:
Σi=0nXi=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 Xi 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.

### Claim 4 (depends on 3)

The system of claim 3, wherein the controller controlling each pump to accomplish a predetermined patient fluid balance.

### Claim 5 (depends on 1)

The system of claim 1, further comprising a semi-permeable membrane, wherein the extracorporeal flow path is in fluid communication with the controlled compliant flow path across the semi-permeable membrane wherein the extracorporeal flow path has a first terminal end and a second terminal end.

### Claim 6 (depends on 5)

The system of claim 5, wherein the first terminal end and the second terminal end are connectable together to form a junction.

### Claim 7 (depends on 6)

The system of claim 6, wherein the junction is between the terminal ends of an arterial line and a venous line of an extracorporeal circuit.

### Claim 8 (depends on 5)

The system of claim 5, 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.

### Claim 9 (depends on 5)

The system of claim 5, further comprising a first valve and/or a second valve, wherein at least the first pump coordinately operates with the first valve and/or the second valve to control fluid movement.

### Claim 10 (depends on 8)

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

### Claim 11 (depends on 8)

The system of claim 8, wherein the first pump and the blood pump on the extracorporeal flow path coordinately operate with the first valve and/or second valve to control fluid movement.

### Claim 12 (depends on 6)

The system of claim 6, wherein the extracorporeal flow path has a hydrophobic vent or a priming overflow reservoir connected to the junction.

### Claim 13 (depends on 5)

The system of claim 5, further comprising a sorbent cartridge on the controlled compliant flow path wherein a fluid passes through the sorbent cartridge prior to crossing the semi-permeable membrane.

### Claim 14 (depends on 5)

The system of claim 5, further comprising a microbial filter on the controlled compliant flow path wherein fluid passes through the microbial filter prior to crossing the semi-permeable membrane.

### Claim 15 (depends on 5)

The system of claim 5, 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.

### Claim 16 (depends on 5)

The system of claim 5, further comprising at least one bubble detector to detect air in the extracorporeal flow path at any one of a first conduit, a second conduit, or both.

### Claim 17 (depends on 5)

The system of claim 5, wherein the controlled compliant flow path has a means for conductivity measurement to verify that a sodium content is within predetermined limits.

### Claim 18 (depends on 5)

The system of claim 5, wherein the controlled compliant flow path has a means for adjusting the solute concentration of fluid in the controlled compliant flow path.

### Claim 19 (depends on 18)

The system of claim 18, wherein the means for adjusting the solute concentration of fluid in the controlled compliant flow path is a sodium chloride source that can increase a sodium chloride concentration of fluid passing through the controlled compliant flow path and a buffer source that can increase a buffer concentration of fluid passing through the controlled compliant flow path.

### Claim 20 (depends on 18)

The system of claim 18, wherein the means for adjusting the solute concentration of fluid in the controlled compliant flow path is a sodium chloride cartridge that can increase a sodium chloride concentration of fluid passing through the cartridge and a buffer source cartridge that can increase a buffer concentration of fluid passing through the buffer source cartridge.

### Claim 21 (depends on 1)

The system of claim 1, wherein the at least one pump 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.

### Claim 22 (depends on 21)

The system of claim 21, wherein the second fluid contains a saline concentration different from the first fluid.

### Claim 23 (depends on 1)

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