# US 2017/0281845 A1 · Peritoneal dialysate fluid generation system

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- Number: US 2017/0281845 A1
- Document ID: US20170281845A1
- Status: Published application
- Kind: A1
- Application number: 15/478,562
- Filed: 2017-04-04
- Published: 2017-10-05
- Earliest claimed: 2016-04-04
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: VenKatesh R. Manda; Martin T. Gerber; Christopher M. Hobot
- Web page: https://patentgrep.com/patent/US20170281845A1

## CPC

- A61M 1/282: {Operational modes}
- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61K 31/7004: Monosaccharides having only carbon, hydrogen and oxygen atoms
- A61K 31/716: Glucans
- A61K 33/00: Medicinal preparations containing inorganic active ingredients
- A61K 33/06: Aluminium, calcium or magnesium; Compounds thereof {, e.g. clay}
- A61K 33/14: Alkali metal chlorides; Alkaline earth metal chlorides
- A61L 2/022: Filtration
- A61L 2/04: Heat (radiation A61L2/08)
- A61L 2/10: Ultraviolet [UV] radiation
- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/1657: {with centralised supply of dialysate or constituent thereof for more than one dialysis unit}
- A61M 1/1672: {using membrane filters, e.g. for sterilising the dialysate}
- A61M 1/1674: {using UV radiation sources for sterilising the dialysate}
- A61M 1/1686: {by heat}
- A61M 1/28: Peritoneal dialysis {; Other peritoneal treatment, e.g. oxygenation}
- A61M 1/287: {Dialysates therefor}
- C02F 1/001: {Processes for the treatment of water whereby the filtration technique is of importance (C02F1/44 takes precedence; construction of filters in general B01D24/00 - B01D41/00)}
- C02F 1/02: by heating (methods of steam generation F22B; preheating boiler feed-water or accumulating preheated boiler feed-water F22D)
- C02F 1/28: by sorption (using ion-exchange C02F1/42; sorbent compositions B01J)
- C02F 1/283: {using coal, charred products, or inorganic mixtures containing them}
- C02F 1/325: {Irradiation devices or lamp constructions}
- C02F 1/42: by ion-exchange (ion-exchange in general B01J)
- C02F 1/441: {by reverse osmosis}
- C02F 1/442: {by nanofiltration}
- C02F 1/444: {by ultrafiltration or microfiltration}
- A61L 2103/05: Living organisms or biological materials
- A61M 1/159: {specially adapted for peritoneal dialysis}
- A61M 1/1666: {by dissolving solids}
- A61M 2205/3337: Controlling, regulating pressure or flow by means of a valve by-passing a pump
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/75: with filters
- A61M 2205/7518: bacterial
- A61M 2209/10: Equipment for cleaning
- C02F 2303/04: Disinfection
- 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)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)

## Abstract

Systems and methods of generating peritoneal dialysate are provided. The systems and methods use a water purification module, a sterilization module and concentrates to prepare a bolus of peritoneal dialysate from source water for use with an non-integrated cycler.

## Claims

### Claim 1

A system, comprising:
a water source;
a peritoneal dialysate generation flow path; wherein the peritoneal dialysate generation flow path is fluidly connectable to the water source;
one or more water purification modules fluidly connectable to the peritoneal dialysate generation flow path;
a concentrate source fluidly connectable to the peritoneal dialysate generation flow path;
the concentrate source containing one or more solutes; and
a sterilization module fluidly connectable to the peritoneal dialysate generation flow path.

### Claim 2 (depends on 1)

The system of claim 1, further comprising one or more dialysate containers fluidly connectable to the peritoneal dialysate generation flow path downstream of the sterilization module.

### Claim 3

(canceled)

### Claim 4 (depends on 1)

The system of claim 1, wherein the concentrate source comprises at least an osmotic agent source and an ion concentrate source.

### Claim 5 (depends on 4)

The system of claim 4, wherein the concentrate source comprises multiple osmotic agent sources, and/or multiple ion concentrate sources.

### Claim 6 (depends on 5)

The system of claim 5, wherein the osmotic agent sources contain osmotic agents selected from the group consisting of dextrose, icodextrin, glucose, and amino acids.

### Claim 7 (depends on 4)

The system of claim 4, wherein the ion concentrate source comprises one or more from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate.

### Claim 8

(canceled)

### Claim 9

(canceled)

### Claim 10

(canceled)

### Claim 11

(canceled)

### Claim 12

(canceled)

### Claim 13

(canceled)

### Claim 14 (depends on 1)

The system of claim 1, further comprising a control system, wherein the control system operates one or more pumps and valves to control movement of fluid through the system; wherein the control system either (a) comprises a timer, wherein the timer causes the control system to generate peritoneal dialysate at a predetermined time; and/or (b) comprises a user interface, wherein the user interface causes the control system to generate peritoneal dialysate at a selected time.

### Claim 15

(canceled)

### Claim 16

(canceled)

### Claim 17 (depends on 1)

The system of claim 1 wherein the sterilization module comprises one or more selected from the group of one or more ultrafilters, a UV light source, a heater, a flash pasteurization module, a microbial filter, and combinations thereof.

### Claim 18 (depends on 17)

The system claim 17, wherein the sterilization module comprises either or both of: a UV light source positioned downstream of an ultrafilter; and/or at least two ultrafilters.

### Claim 19

(canceled)

### Claim 20 (depends on 1)

The system of claim 1, wherein the water purification module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter, and a nanofilter.

### Claim 21

A method, comprising the steps of:
pumping fluid from a water source to a water purification module in a peritoneal dialysate generation flow path;
adding one or more concentrate solutions to the fluid; and
pumping the fluid through a sterilization module.

### Claim 22 (depends on 21)

The method of claim 21, further comprising the step of pumping the fluid into one or more dialysate containers.

### Claim 23

(canceled)

### Claim 24

(canceled)

### Claim 25

(canceled)

### Claim 26

(canceled)

### Claim 27

(canceled)

### Claim 28

(canceled)

### Claim 29 (depends on 21)

The method of claim 21, wherein the step of adding one or more concentrate solutions to the fluids comprises adding at least an osmotic agent and an ion concentrate to the fluid; wherein the osmotic agent and ion concentrate are added to the fluid from a single concentrate source; or wherein the osmotic agent and ion concentrate are added to the fluid from separate concentrate sources.

### Claim 30

(canceled)

### Claim 31 (depends on 29)

The method of claim 29, wherein the osmotic agent is one or more selected from the group consisting of glucose, dextrin, and icodextrin.

### Claim 32

(canceled)

### Claim 33 (depends on 29)

The method of claim 29, wherein multiple osmotic agents are added to the fluid from a single osmotic agent source or wherein multiple osmotic agents are added to the fluid from separate osmotic agent sources; and wherein each of the ion concentrates are added to the fluid from a single ion concentrate source or wherein multiple ion concentrates are added to the fluid from separate ion concentrate sources.

### Claim 34

(canceled)

### Claim 35 (depends on 29)

The method of claim 29, wherein the ion concentrate is added from one or more ion concentrate sources and comprises one or more from the group consisting of sodium chloride, sodium lactate, magnesium chloride, calcium chloride, potassium chloride, and sodium bicarbonate.

### Claim 36

(canceled)

### Claim 37

(canceled)

### Claim 38

(canceled)

### Claim 39 (depends on 21)

The method of claim 21, wherein the method is carried out by a peritoneal dialysate generation system; wherein the peritoneal dialysate generation system comprises either or both of (a) a timer, wherein the peritoneal dialysate generation system carries out the method at predetermined times; and/or (b) a user interface, wherein the method is carried out based on input from the user interface.

### Claim 40

(canceled)

### Claim 41

(canceled)

### Claim 42 (depends on 21)

The method of claim 21, wherein the water purification module comprises one or more selected from the group consisting of a sorbent cartridge, activated carbon, a reverse osmosis module, a carbon filter and a nanofilter.

### Claim 43 (depends on 21)

The method of claim 21, wherein the sterilization module comprises one or more selected from the group of one or more ultrafilters, a UV light source, a microbial filter, and combinations thereof.

### Claim 44 (depends on 43)

The method of claim 43, wherein the sterilization module comprises either or both of the UV light source positioned downstream of the ultrafilter, and/or at least two ultrafilters.

### Claim 45

(canceled)