BLOOD TREATMENT SYSTEMS AND METHODS

• US 20170143886A1
• Filed: 02/03/2017
• Published: 05/25/2017
• Est. Priority Date: 05/24/2011
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: WILT, MICHAEL J., VAN DER MERWE, DIRK A., BALLANTYNE, TODD A., ROSSE, JONATHAN P., FLYNN, CATHARINE N., YEE, BRIAN K., GRANT, KEVIN L.
• Granted Patent: US 11,103,625 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• 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 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/1561 at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/15625 the reservoirs acting as balance chambers
• CPC Class Codes: A61M 1/15632 the filter being a dialyser
• CPC Class Codes: A61M 1/1565 Details of valves
• 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 1/1613 Profiling or modelling of patient or predicted treatment evolution or outcome
• CPC Class Codes: A61M 1/1619 Sampled collection of used dialysate, i.e. obviating the need for recovery of whole dialysate quantity for post-dialysis analysis
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• 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 1/1692 : Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/267 : used for pumping
• CPC Class Codes: A61M 1/301 : Details
• CPC Class Codes: A61M 1/34 : Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/341 : by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3413 : Diafiltration
• CPC Class Codes: A61M 1/3603 : in the same direction
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3621 : Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/362227 : the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 : with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 : with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 : Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362261 : at least one cassette surface or portion thereof being flexible, e.g. the cassette having a rigid base portion with preformed channels and being covered with a foil
• CPC Class Codes: A61M 1/362264 : the filter being a blood filter
• CPC Class Codes: A61M 1/362265 : Details of valves
• CPC Class Codes: A61M 1/362266 : Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3638 : with a vapour trap
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3306 : Optical measuring means
• CPC Class Codes: A61M 2205/3313 : used specific wavelengths
• 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 2205/3379 : Masses, volumes, levels of fluids in reservoirs, flow rates
• CPC Class Codes: A61M 2205/3569 : sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• 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 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 5/172 : electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/268 : the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/37 : Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/43 : using vacuum at the blood pump, e.g. to accelerate filling
• CPC Class Codes: A61M 60/837 : Aspects of flexible displacement members, e.g. shapes or materials
• CPC Class Codes: A61M 60/847 : arranged in a cassette
• CPC Class Codes: A61M 60/851 : Valves
• CPC Class Codes: A61M 60/892 : Active valves, i.e. actuated by an external force
• CPC Class Codes: A61M 60/894 : Passive valves, i.e. valves actuated by the blood
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: Y02A 50/30 : Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Dialysis systems are disclosed comprising new fluid flow circuits. Systems may include blood and dialysate flow paths, where the dialysate flow path includes balancing, mixing, and/or directing circuits. Dialysate preparation may be decoupled from patient dialysis. Circuits may be defined within one or more cassettes. The fluid circuit fluid flow paths may be isolated from electrical components. A gas supply in fluid communication with the dialysate flow path and/or the dialyzer able to urge dialysate through the dialyzer and urge blood back to the patient may be included for certain emergency situations. Fluid handling devices, such as pumps, valves, and mixers that can be actuated using a control fluid may be included. Control fluid may be delivered by an external pump or other device, which may be detachable and/or generally rigid, optionally with a diaphragm dividing the device into first and second compartments.

Claims

1-218. -218. (canceled)

219. An accumulator, comprising:

a chamber having at least one port for receiving liquid into the chamber;

a moveable diaphragm in the chamber that separates a liquid side of the chamber from a gas side of the chamber; and

a vent arranged to continuously vent the gas side of the chamber.

220. A dialysis system, comprising:

a mixing circuit arranged to combine at least water and one ingredient to form dialysate used in a dialysis treatment;

a water supply arranged to provide water to the mixing circuit via a water supply conduit; and

the accumulator of claim 219 arranged to receive and release water via the at least one port in fluid communication with the water supply conduit.

221. The system of claim 220, wherein the accumulator is arranged to store a volume of water equal to about 27 ml.

222. The system of claim 220, wherein the accumulator is arranged to receive and hold water from the water supply conduit during periods when the mixing circuit is not drawing water from the water supply conduit, and is arranged to supply water to the water supply conduit during periods when the mixing circuit is drawing water from the water supply conduit.

223. The system of claim 220, wherein the water supply includes a container of water suitable for the formation of dialysate.

224. The system of claim 220, wherein the water supply includes a reverse osmosis filter.

225. The system of claim 220, wherein the water supply provides water to the water supply conduit at a pressure that is lower in absolute value than a negative pressure used by the mixing circuit to draw water from the water supply conduit.

226. The system of claim 225, wherein the water supply includes a pressure regulator.

227. The system of claim 220, wherein the mixing circuit includes one or more pumps that draw water from the water supply conduit.

228. The system of claim 220, wherein the mixing circuit includes one or more pumps that intermittently draws water from the water supply conduit.

229. The system of claim 228, wherein the water supply is arranged to provide water on a continuous basis.

230. The system of claim 220, further comprising an air trap in fluid communication with the water supply conduit and arranged to trap air in the water supply conduit.

231. The system of claim 230, wherein the air trap is arranged to trap up to about 1.5 ml of air.

232. The system of claim 230, wherein the air trap is arranged to trap air at a rate of up to about 10 ml/hour with a flow of water of about 1200 ml/minute through the air trap.

233. The system of claim 230, wherein the mixing circuit, the water supply, the water conduit and/or the accumulator are arranged to cause a negative pressure to be present in the air trap during at least a portion of a cycle in which a pump of the mixing chamber draws water from the water supply conduit.

234. The accumulator of claim 219, wherein the vent includes an orifice having a size of about 0.004 inches.

235. The accumulator of claim 219, wherein the chamber is arranged to store a volume of water equal to about 27 ml in the liquid side.

236. The accumulator of claim 219, wherein the membrane includes a flexible, hemispherically shaped element attached to the chamber.

237. The accumulator of claim 219, wherein the vent comprises a controllably variable orifice valve.

238. The accumulator of claim 219, wherein the vent includes an orifice that is configured for connection to a source of negative pressure or a source of positive pressure.

239. A method for operating a dialysis system, comprising:

receiving water from a water supply at a mixing circuit via a water supply conduit, the mixing circuit being arranged to combine at least water and one ingredient to form dialysate used in a dialysis treatment;

providing water from an accumulator into the water supply conduit when the mixing circuit draws water from the water supply conduit; and

receiving water from the water supply conduit in the accumulator when the mixing circuit does not draw water from the water supply conduit.

240. The method of claim 239, wherein the water supply provides water to the water supply conduit at a pressure that is lower in absolute value than a negative pressure used by the mixing circuit to draw water from the water supply conduit.

241. The method of claim 240, wherein the water supply includes a pressure regulator.

242. The method of claim 239, wherein the step of receiving includes drawing water from the water supply conduit using one or more pumps in the mixing circuit.

243. The method of claim 242, wherein the one or more pumps are operated to intermittently draw water from the water supply conduit.

244. The method of claim 243, wherein the water supply is arranged to provide water to the water supply conduit on a continuous basis.

245. The method of claim 239, further comprising:

trapping air in the water supply conduit in an air trap.

246. The method of claim 245, wherein the air trap is arranged to trap up to about 1.5 ml of air.

247. The method of claim 245, wherein the air trap is arranged to trap air at a rate of up to about 10 ml/hour with a flow of water of about 1200 ml/minute through the air trap.

248. The method of claim 245, wherein the accumulator is in fluid communication with the water supply conduit between the air trap and the water supply.

249. The method of claim 239, wherein the accumulator includes a moveable diaphragm that separates a liquid side of the accumulator from a gas side of the accumulator.

250. The method of claim 239, wherein the step of receiving water from the water supply conduit in the accumulator includes venting the gas side of the accumulator to atmospheric pressure.

251. The method of claim 250, wherein the step of providing water from the accumulator to the water supply conduit includes venting the gas side of the accumulator to atmospheric pressure.

252. The method of claim 239, wherein the accumulator is arranged to store a volume of water equal to about 27 ml.

253. The method of claim 239, wherein the step of receiving includes;

causing a negative pressure to be present in the water supply conduit when the mixing chamber draws water from the water conduit.

254. The method of claim 253, wherein the negative pressure causes dissolved gas in the water to be released from the water and trapped in an air trap.

255. The method of claim 253, wherein the negative pressure causes water to be provided from the accumulator to the water supply conduit.

256. The method of claim 253, wherein the negative pressure is caused, at least in part, by one or more pumps of the mixing circuit drawing water from the water supply conduit.

257. The method of claim 256, wherein the accumulator is arranged to maintain the negative pressure after the one or more pumps of the mixing circuit stop drawing water from the water supply conduit.