# US 10,441,700 B2 · Medicament preparation and treatment devices, methods, and systems

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- Number: US 10,441,700 B2
- Document ID: US10441700B2
- Status: Granted
- Kind: B2
- Application number: 15/514,230
- Filed: 2015-09-25
- Published: 2017-10-12
- Granted: 2019-10-15
- Earliest claimed: 2014-09-25
- Assignees: NxStage Medical, Inc.
- Applicants: Nxstage Medical, Inc.
- Inventors: Goetz Friederichs; William Weigel; Dennis M. Treu; Jeffrey H. Burbank; James M. Brugger; Keith J. Wheeler; Scott W. Newell
- Web page: https://patentgrep.com/patent/US10441700B2

## CPC

- A61M 1/1666: {by dissolving solids}
- A61K 31/191: having two or more hydroxy groups, e.g. gluconic acid
- A61M 1/166: {Heating (for sterilisation A61M1/1686)}
- A61M 1/1658: {Degasification}
- B01F 1/0022
- C02F 9/00: Multistage treatment of water, waste water or sewage
- F15B 1/04: Accumulators
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3368: Temperature
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/6054: Magnetic identification systems
- A61M 2205/6072: Bar codes
- C02F 1/20: by degassing, i.e. liberation of dissolved gases (degasification of liquids in general B01D19/00; arrangement of degassing apparatus in boiler feed supply F22D)
- C02F 1/283: {using coal, charred products, or inorganic mixtures containing them}
- C02F 1/42: by ion-exchange (ion-exchange in general B01J)
- C02F 1/44: by dialysis, osmosis or reverse osmosis {(general membrane separation processes B01D61/00, membrane modules B01D63/00, electrodialysis C02F1/4693, combination of membrane modules and bioreactors C02F3/1268)}
- C02F 2001/425: {using cation exchangers}
- C02F 2001/427: {using mixed beds}
- C02F 2103/026: {Treating water for medical or cosmetic purposes}
- C02F 2103/04: for obtaining ultra-pure water
- C02F 2209/05: Conductivity or salinity
- C02F 2209/445: Filter life
- F15B 2201/315: having flexible separating means
- Y02A 50/401
- 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)}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- B01F: MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING (mixing paints B44D3/06)
- C02F: TREATMENT OF WATER, WASTE WATER, SEWAGE, OR SLUDGE (separation in general B01D; special arrangements on waterborne vessels of installations for treating water, waste water or sewage, e.g. for producing fresh water, B63J; adding materials to water to prevent corrosion C23F; treating radioactively-contaminated liquids G21F9/04; regeneration of reactants for recirculation into processes, see the relevant places for the processes)
- F15B: SYSTEMS ACTING BY MEANS OF FLUIDS IN GENERAL; FLUID-PRESSURE ACTUATORS, e.g. SERVOMOTORS; DETAILS OF FLUID-PRESSURE SYSTEMS, NOT OTHERWISE PROVIDED FOR
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

A medicament preparation system, according to an embodiment, includes a water purification module and a medicament proportioning module. The system is configured to allow convenient and safe use in a home environment or a critical care environment as well as others affording safety, reliability, and a compact form factor.

## Claims

### Claim 1

A fluid circuit for preparation of a medicament for renal replacement therapy, comprising:
a concentrate container containing acid concentrate connected for flow communication, through a first pumping tube segment, to a medicament supply line that has been capped and sterile-sealed at an outlet end thereof;
a bicarbonate cartridge containing dry bicarbonate buffer compound, the bicarbonate cartridge being of a type that admits water in a cartridge inlet thereby forming a saturated bicarbonate solution which is received at a cartridge outlet, the cartridge outlet being connected for flow communication, through a second pumping tube segment, to the medicament supply line; and
a water inlet line, capped and sterile-sealed, connected for flow communication, through a third pumping tube segment, to the medicament supply line and connected for flow communication to the bicarbonate cartridge inlet;
the first, second, and third pumping tube segments being supported by a circuit cartridge which orients, aligns, and exposes for access the first, second, and third pumping tube segments with respective actuators of a predefined medicament preparation device;
the circuit cartridge containing a first concentration sensor station positioned in said medicament supply line downstream of a first junction where the first pumping tube segment connects to the medicament supply line;
the circuit cartridge containing a second concentration sensor station positioned in said medicament supply line downstream of both said first junction and a second junction where the second pumping tube segment connects to the medicament supply line, wherein
each of said concentration sensor stations includes a liquid conductivity sensor and a temperature sensor portion,
the temperature sensor portion includes a flow chamber with a flat surface to permit a temperature sensor to be placed against said flat surface of a predefined sensor of the predefined medicament preparation device, and
the entire fluid circuit is sterile.

### Claim 2 (depends on 1)

The circuit of claim 1, wherein the circuit cartridge includes a fluid accumulator fluidly coupled between the water inlet line and the medicament supply line outlet end that includes a pressure-regulating urging element that biases a flexible wall of the accumulator such that transient changes of fluid pressure therein cause expansion of the volume of the accumulator.

### Claim 3 (depends on 1)

The circuit of claim 1, wherein the fluid circuit is packaged with a box such that the circuit cartridge can be detached or removed from the box while leaving the concentrate container and bicarbonate cartridge intact therein with lengths of connecting lines between the circuit cartridge and the box, thereby permitting the circuit cartridge to be installed in a position remote form a position where the box is installed.

### Claim 4 (depends on 1)

The circuit of claim 1, wherein the fluid circuit is packaged within a box such that the circuit cartridge can be removed from the box while leaving the concentrate container and bicarbonate cartridge intact therein with lengths of connecting lines between the circuit cartridge and the box, thereby permitting the circuit cartridge to be installed in a position remote form a position where the box is installed.

### Claim 5 (depends on 1)

The circuit of claim 1, wherein the fluid circuit is attached to a box in such a way that the circuit cartridge can be detached from the box while leaving the concentrate container and bicarbonate cartridge intact therein with lengths of connecting lines between the circuit cartridge and the box, thereby permitting the circuit cartridge to be installed in a position remote form a position where the box is installed.

### Claim 6 (depends on 3)

The circuit of claim 3, wherein the box is principally of cardboard.

### Claim 7 (depends on 1)

The circuit of claim 1, wherein each of said concentration stations includes, connected in series, two independent conductivity sensors and two independent temperature sensor portions.

### Claim 8 (depends on 2)

The circuit of claim 2, wherein the medicament supply line includes a waste outlet branch that is in direct fluid communication with the accumulator, the waste outlet branch being capped and sterile-sealed, the medicament supply line outlet line and waste outlet branch having pinching portions supported in an open section of said circuit cartridge to permit access by pinching actuators.

### Claim 9

A fluid circuit for preparation of a medicament for renal replacement therapy, comprising:
a first container containing acid concentrate connected for flow communication, through a first pumping tube segment, to a medicament supply line that has been capped and sterile-sealed at an outlet end thereof;
a second container containing a buffer concentrate connected for flow communication, through a second pumping tube segment, to the medicament supply line; and
a water inlet line, capped and sterile-sealed, connected for flow communication, through a third pumping tube segment, to the medicament supply line;
the first, second, and third pumping tube segments being supported by a circuit cartridge which orients, aligns, and exposes for access the first, second, and third pumping tube segments with respective actuators of a predefined medicament preparation device;
the circuit cartridge containing a first concentration sensor station positioned in said medicament supply line downstream of a first junction where the first pumping tube segment connects to the medicament supply line;
the circuit cartridge containing a second concentration sensor station positioned in said medicament supply line downstream of both said first junction and a second junction where the second pumping tube segment connects to the medicament supply line, wherein
each of said concentration sensor stations includes a liquid conductivity sensor and a temperature sensor portion,
the temperature sensor portion includes a flow chamber with a flat surface to permit a temperature sensor to be placed against said flat surface of a predefined sensor of the predefined medicament preparation device, and
the entire fluid circuit is sterile.

### Claim 10 (depends on 9)

The circuit of claim 9, wherein the circuit cartridge includes a fluid accumulator fluidly coupled between the water inlet line and the medicament supply line outlet end that includes a pressure-regulating urging element that biases a flexible wall of the accumulator such that transient changes of fluid pressure therein cause expansion of the volume of the accumulator.

### Claim 11 (depends on 9)

The circuit of claim 9, wherein the fluid circuit is packaged with a box such that the circuit cartridge can be detached or removed from the box while leaving the first and second containers therein with lengths of connecting lines between the circuit cartridge and the box, thereby permitting the circuit cartridge to be installed in a position remote form a position where the box is installed.

### Claim 12 (depends on 9)

The circuit of claim 9, wherein the fluid circuit is packaged within a box such that the circuit cartridge can be removed from the box while leaving the first and second containers therein with lengths of connecting lines between the circuit cartridge and the box, thereby permitting the circuit cartridge to be installed in a position remote form a position where the box is installed.

### Claim 13 (depends on 9)

The circuit of claim 9, wherein the fluid circuit is attached to a box in such a way that the circuit cartridge can be detached from the box while leaving the first and second containers therein with lengths of connecting lines between the circuit cartridge and the box, thereby permitting the circuit cartridge to be installed in a position remote form a position where the box is installed.

### Claim 14 (depends on 11)

The circuit of claim 11, wherein the box is principally of cardboard.

### Claim 15 (depends on 9)

The circuit of claim 9, wherein each of said concentration stations includes, connected in series, two independent conductivity sensors and two independent temperature sensor portions.

### Claim 16 (depends on 10)

The circuit of claim 10, wherein the medicament supply line includes a waste outlet branch that is in direct fluid communication with the accumulator, the waste outlet branch being capped and sterile-sealed, the medicament supply line outlet line and waste outlet branch having pinching portions supported in an open section of said circuit cartridge to permit access by pinching actuators.