# US 11,116,067 B2 · Renal failure therapy system having electrically floating fluid pathway

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- Number: US 11,116,067 B2
- Document ID: US11116067B2
- Status: Granted
- Kind: B2
- Application number: 15/766,087
- Filed: 2016-10-14
- Published: 2018-10-25
- Granted: 2021-09-07
- Earliest claimed: 2015-10-14
- Assignees: Gambro Lundia AB
- Applicants: Gambro Lundia AB
- Inventors: Sture Hobro; Erik Torgny; Par Lofgren
- Web page: https://patentgrep.com/patent/US11116067B2

## CPC

- A61M 1/16: with membranes
- 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 1/34: Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
- A61M 1/3413: {Diafiltration}
- A61M 1/3621: {Extra-corporeal blood circuits (single-needle circuits A61M1/30)}
- A61M 1/367: {Circuit parts not covered by the preceding subgroups of group A61M1/3621}
- H05F 3/02: by means of earthing connections
- A61M 2205/18: with alarm
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3334: Measuring or controlling the flow rate
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3351: Controlling upstream pump pressure
- A61M 2205/3368: Temperature
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/581: by audible feedback
- A61M 2205/583: by visual feedback
- A61M 2205/70: with testing or calibration facilities
- A61M 2205/702: automatically during use
- 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)}
- H05F: STATIC ELECTRICITY; NATURALLY-OCCURRING ELECTRICITY

## Abstract

A renal failure therapy system (10) includes a dialyzer (102); a blood circuit (100) in fluid communication with the dialyzer (102); a dialysis fluid circuit (30) in fluid communication with the dialyzer (102); and an electrically floating fluid pathway (140) comprising at least a portion of the blood circuit (100) and at least a portion of the dialysis fluid circuit (30), wherein the only electrical path to ground is via used dialysis fluid traveling through machine (12) to earth ground (28), and wherein at least one electrical component (46, 90, 82, 66, 102, 116) in the at least a portion of the dialysis fluid circuit (30) of the electrically floating fluid pathway (140) is electrically bypassed.

## Claims

### Claim 1

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer; and
an electrically floating fluid pathway comprising at least a portion of the blood circuit and at least a portion of the dialysis fluid circuit, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground,
wherein at least one electrical component in the at least a portion of the dialysis fluid circuit of the electrically floating fluid pathway is electrically bypassed, and
wherein the at least a portion of the dialysis fluid circuit includes at least a portion of a fresh dialysis fluid line and at least a portion of a used dialysis fluid line.

### Claim 2 (depends on 1)

The renal failure therapy system of claim 1, wherein (i) the electrically bypassed portion of the dialysis fluid circuit of the electrically floating fluid pathway is electrically short circuited or (ii) the electrical component is of a type sensitive to electrical disturbances.

### Claim 3 (depends on 1)

The renal failure therapy system of claim 1, wherein the electrically bypassed portion of the dialysis fluid circuit of the electrically floating fluid pathway includes (i) at least one electrical line placed in parallel with the at least one electrical component, (ii) a small passage formed between a fluid inlet and a fluid outlet to the at least one electrical component, or (iii) a conductor located between the fluid inlet and the fluid outlet of the at least one electrical component.

### Claim 4 (depends on 3)

The renal failure therapy system of claim 3, wherein the at least one electrical line placed in parallel with the at least one electrical component includes upstream and downstream conductive couplers placed in fluid lines upstream and downstream, respectively, of the electrical component, and wherein the electrical line is extended from the upstream conductive coupler to the downstream conductive coupler.

### Claim 5 (depends on 1)

The renal failure therapy system of claim 1, wherein the at least one electrical component includes a conductivity sensor having a conductivity probe that contacts dialysis fluid flowing through the at least a portion of the dialysis fluid circuit.

### Claim 6 (depends on 1)

The renal failure therapy system of claim 1, wherein the at least one electrical component includes a flowmeter for measuring the flowrate of dialysis fluid flowing through the at least a portion of the dialysis fluid circuit.

### Claim 7 (depends on 1)

The renal failure therapy system of claim 1, comprising at least one electrically bypassed electrical component in the at least a portion of the fresh dialysis fluid line and at least one electrically bypassed electrical component in the at least a portion of the used dialysis fluid line.

### Claim 8 (depends on 1)

The renal failure therapy system of claim 1, wherein the electrically floating fluid pathway includes an electrical line extending from the at least a portion of the fresh dialysis fluid line to the at least a portion of the used dialysis fluid line, the electrical line positioned to bypass the dialyzer and a patient to be treated.

### Claim 9 (depends on 1)

The renal failure therapy system of claim 1, wherein the electrically floating fluid pathway includes at least one selected from the group consisting of an arterial line, a venous line, arterial and venous needles, a fresh dialysis fluid line, a fresh dialysis fluid tube, liquid concentrate lines, concentrate sources if liquid concentrate sources are used, a water line, a water source if the water is non-deionized, a used dialysis fluid tube, and a used dialysis fluid line.

### Claim 10 (depends on 1)

The renal failure therapy system of claim 1, wherein the electrically floating fluid pathway is connected to an external drain line, which leads to an electrically grounded drain.

### Claim 11 (depends on 1)

The renal failure therapy system of claim 1, wherein the electrically floating fluid pathway includes at least one fluid component that is not electrically bypassed, but which is electrically insulated from a chassis of the system to form a delineated applied part.

### Claim 12

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer, the dialysis fluid circuit including a fresh dialysis fluid line and a used dialysis fluid line;
a first electrical component operable with the fresh dialysis fluid line;
a first electrical bypass shunting current away from the first electrical component;
a second electrical component operable with the used dialysis fluid line; and
a second electrical bypass shunting current away from the second electrical component.

### Claim 13 (depends on 12)

The renal failure therapy system of claim 12, wherein the first and second electrical bypasses are part of an electrically floating fluid pathway in which the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground.

### Claim 14 (depends on 13)

The renal failure therapy system of claim 13, wherein the electrically floating fluid pathway includes a plurality of fluid operating components located along the fresh dialysis fluid line and the used dialysis fluid line, wherein the fluid operating components are not electrically bypassed.

### Claim 15 (depends on 14)

The renal failure therapy system of claim 14, wherein the plurality of fluid operating components include at least one selected from the group consisting of (i) a pump and (ii) a component mounted to a system chassis via an electrical insulator.

### Claim 16 (depends on 12)

The renal failure therapy system of claim 12, wherein the first and second electrical bypasses contact fluid upstream and downstream of the first and second electrical components, respectively, the fluid electrically connecting the first and second electrical bypasses.

### Claim 17

A renal failure therapy machine operating with a dialyzer and a blood circuit in fluid communication with the dialyzer, the machine comprising:
a dialysis fluid circuit in fluid communication with the dialyzer, the dialysis fluid circuit including a fresh dialysis fluid line and a used dialysis fluid line; and
an electrically floating fluid pathway, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy machine to earth ground, and including an electrical bypass from the fresh dialysis fluid line to the used dialysis fluid line, such that a fault current generated in the fresh dialysis fluid line bypasses the dialyzer via the electrical bypass to the used dialysis fluid line.

### Claim 18 (depends on 17)

The renal failure therapy machine of claim 17, wherein the electrical bypass is (i) located between a furthest downstream fluid component of the fresh dialysis fluid line and the dialyzer, or (ii) located between a furthest upstream fluid component of the used dialysis fluid line and the dialyzer.

### Claim 19 (depends on 17)

The renal failure therapy machine of claim 17, wherein the electrically floating fluid pathway includes at least one additional electrical bypass shunting current away from an electrical component located in the fresh or used dialysis fluid lines.

### Claim 20

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer;
an electrically floating fluid pathway comprising at least a portion of the dialysis fluid circuit, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground, and wherein at least one electrical component in the at a least portion of the dialysis fluid circuit of the electrically floating fluid pathway is electrically insulated; and
a testing structure configured to test whether the electrically floating fluid pathway has been compromised via an undesired electrical connection to ground, wherein the testing structure optionally includes a generator selected from the group consisting of a current generator and a voltage generator, and a meter selected from the group consisting of a voltage meter and a current meter,
wherein the system is programmed to use (i) the generator to set a limit and (ii) the meter to determine if the limit has been reached,
wherein the testing structure includes an electrical path from at least one bypass bypassing the at least one electrical component to ground, and
wherein the meter is in the electrical path.

### Claim 21 (depends on 20)

The renal failure therapy system of claim 20, wherein the testing structure includes the generator and the meter, the system includes a switch in electrical communication with the generator, and the system is programmed to close the switch before treatment for (i) and open the switch during treatment for (ii).

### Claim 22 (depends on 20)

The renal failure therapy system of claim 20, wherein the testing structure includes the meter placed in electrical communication with first and second bypasses shunting current away from the at least one electrical component located in fresh or used dialysis fluid lines.

### Claim 23

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer; and
an electrically floating fluid pathway comprising at least a portion of the blood circuit and at least a portion of the dialysis fluid circuit, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground, and wherein at least one electrical component in the at least a portion of the dialysis fluid circuit of the electrically floating fluid pathway includes an electrical bypass having (i) a small passage formed between a fluid inlet and a fluid outlet to the at least one electrical component, or (ii) a conductor located between the fluid inlet and the fluid outlet of the at least one electrical component.

### Claim 24

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer; and
an electrically floating fluid pathway comprising at least a portion of the blood circuit and at least a portion of the dialysis fluid circuit, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground,
wherein at least one electrical component in the at least a portion of the dialysis fluid circuit of the electrically floating fluid pathway is electrically bypassed, and
wherein the at least one electrical component includes a conductivity sensor having a conductivity probe that contacts dialysis fluid flowing through the at least a portion of the dialysis fluid circuit.

### Claim 25

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer; and
an electrically floating fluid pathway comprising at least a portion of the blood circuit and at least a portion of the dialysis fluid circuit, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground,
wherein at least one electrical component in the at least a portion of the dialysis fluid circuit of the electrically floating fluid pathway is electrically bypassed, and
wherein the electrically floating fluid pathway includes at least one selected from the group consisting of an arterial line, a venous line, arterial and venous needles, a fresh dialysis fluid line, a fresh dialysis fluid tube, liquid concentrate lines, concentrate sources if liquid concentrate sources are used, a water line, a water source if the water is non-deionized, a used dialysis fluid tube, and a used dialysis fluid line.

### Claim 26

A renal failure therapy system comprising:
a dialyzer;
a blood circuit in fluid communication with the dialyzer;
a dialysis fluid circuit in fluid communication with the dialyzer; and
an electrically floating fluid pathway comprising at least a portion of the blood circuit and at least a portion of the dialysis fluid circuit, wherein the only electrical path to ground is via used dialysis fluid traveling through the renal failure therapy system to earth ground,
wherein at least one electrical component in the at least a portion of the dialysis fluid circuit of the electrically floating fluid pathway is electrically bypassed, and
wherein the electrically floating fluid pathway is connected to an external drain line, which leads to an electrically grounded drain.
