# US 5,702,606 A · Method of priming dialyzer

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- Number: US 5,702,606 A
- Document ID: US5702606A
- Status: Granted
- Kind: A
- Application number: 08/560,439
- Filed: 1995-11-17
- Granted: 1997-12-30
- Earliest claimed: 1995-02-13
- Assignees: Aksys, Ltd.
- Inventors: Frederick H. Peter, Jr.; Eric Bell; Thomas M. Feldsein
- Web page: https://patentgrep.com/patent/US5702606A

## CPC

- B01D 65/102: {Detection of leaks in membranes}
- A61L 2/04: Heat (radiation A61L2/08)
- A61L 2/18: Liquid substances
- A61M 1/16: with membranes
- A61M 1/1607: {before use, i.e. upstream of dialyser}
- A61M 1/1609: {after use, i.e. downstream of dialyser}
- A61M 1/1649: {with pulsatile dialysis fluid flow}
- A61M 1/165: {with a dialyser bypass on the dialysis fluid line}
- A61M 1/1656: {Apparatus for preparing dialysates}
- A61M 1/166: {Heating (for sterilisation A61M1/1686)}
- A61M 1/1662: {with heat exchange between fresh and used dialysate}
- 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 1/1682: {both machine and membrane module, i.e. also the module blood side}
- A61M 1/1684: {Checking the module characteristics before reuse}
- A61M 1/1686: {by heat}
- A61M 1/1688: {with recirculation of the sterilising fluid}
- A61M 1/169: {using chemical substances}
- A61M 1/1692: {Detection of blood traces in dialysate}
- A61M 1/1694: {with recirculating dialysing liquid}
- A61M 1/288: {Priming (priming in extracorporeal blood circuits A61M1/3643)}
- A61M 1/3434: {with pre-dilution and post-dilution}
- A61M 1/3437: {downstream of the filter, e.g. post-dilution with filtrate}
- A61M 1/3465: {using dialysate as substitution fluid}
- A61M 1/3468: {using treated filtrate as substitution fluid}
- A61M 1/3609: {Physical characteristics of the blood, e.g. haematocrit, urea}
- A61M 1/3622: {with a cassette forming partially or totally the blood circuit}
- A61M 1/36224: {with sensing means or components thereof}
- A61M 1/36226: {Constructional details of cassettes, e.g. specific details on material or shape}
- A61M 1/362263: {Details of incorporated filters}
- A61M 1/3626: {Gas bubble detectors}
- A61M 1/3627: {Degassing devices; Buffer reservoirs; Drip chambers; Blood filters}
- A61M 1/3629: {degassing by changing pump speed, e.g. during priming}
- A61M 1/3639: {Blood pressure control, pressure transducers specially adapted therefor}
- A61M 1/3641: {Pressure isolators}
- A61M 1/3643: {Priming, rinsing before or after use}
- A61M 1/3644: {Mode of operation}
- A61M 1/3646: {Expelling the residual body fluid after use, e.g. back to the body}
- A61M 1/3647: {with recirculation of the priming solution}
- A61M 1/3649: {using dialysate as priming or rinsing liquid}
- A61M 1/365: {through membranes, e.g. by inverted trans-membrane pressure [TMP]}
- B01D 61/02: Reverse osmosis; Hyperfiltration {; Nanofiltration}
- B01D 61/025: {Reverse osmosis; Hyperfiltration}
- B01D 61/04: Feed pretreatment
- B01D 61/12: Controlling or regulating
- B01D 61/32: Controlling or regulating
- B01D 65/022: {Membrane sterilisation}
- B01D 65/104: {Detection of leaks in membrane apparatus or modules}
- C02F 1/441: {by reverse osmosis}
- F16K 17/0453: {the member being a diaphragm}
- A61M 1/1658: {Degasification}
- A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)}
- A61M 2205/12: with interchangeable cassettes forming partially or totally the fluid circuit
- A61M 2205/15: Detection of leaks
- A61M 2205/17: with redundant control systems
- A61M 2205/18: with alarm
- A61M 2205/3317: Electromagnetic, inductive or dielectric measuring means
- A61M 2205/3324: PH measuring means
- A61M 2205/3331: Pressure; Flow
- A61M 2205/3344: Measuring or controlling pressure at the body treatment site
- A61M 2205/3368: Temperature
- A61M 2205/3382: Upper level detectors
- A61M 2205/3386: Low level detectors
- 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 2205/6072: Bar codes
- A61M 2205/705: Testing of filters for leaks
- A61M 2205/707: Testing of filters for clogging
- A61M 2205/7554: with means for unclogging or regenerating filters
- A61M 2205/7581: with means for switching over to a fresh filter on clogging or saturation
- A61M 2206/11: Laminar flow
- A61M 2230/65: Impedance, e.g. conductivity, capacity
- B01D 2311/04: Specific process operations in the feed stream; Feed pretreatment
- B01D 2321/04: Backflushing
- B01D 2321/16: Use of chemical agents
- B01D 2321/32: By heating or pyrolysis
- Y10S 210/929: Hemoultrafiltrate volume measurement or control processes
- Y10S 215/03: Medical
- Y10T 137/7722: Line condition change responsive valves
- Y10T 137/7794: With relief valve
- Y10T 137/7796: Senses inlet pressure
- Y10T 137/7799: Liquid transfer
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)
- 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)
- 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)}
- 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)
- F16K: VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING {(devices for emptying and evacuating the excess liquid in valves or conduits F16L55/07)}
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION

## Abstract

A method is described for priming a dialyzer placed in an extracorporeal circuit of a hemodialysis machine in situ. The method comprises the steps of substantially filling the extracorporeal circuit and the blood side of the dialyzer with fluid (such as dialysate, RO water, saline, etc.), and inducing pressure pulses in the fluid. The pressure pulses cause air bubbles from the blood side of the dialyzer to be sheared off the dialyzer membrane. The air bubbles are then conducted from the dialyzer and removed from the extracorporeal circuit. Backfiltering of fluid across the dialyzer from the dialysate circuit into the extracorporeal circuit is performed in synchrony with the pressure pulses to assist in the shearing off of air bubbles from the blood side of the dialyzer membrane.

## Claims

### Claim 1

A method of automatically priming a dialyzer in an extracorporeal circuit, said dialyzer having a membrane and a blood side thereof and a dialysate side thereof, the method performed in situ in a dialysis machine, comprising the steps of:
substantially filling said extracorporeal circuit and said blood side of said dialyzer with fluid;
inducing multiple brief pressure pulses in said fluid in said extracorporeal circuit and blood side of said dialyzer, said multiple brief pressure pulses causing air bubbles on said membrane on said blood side of said dialyzer to be sheared off the blood side of said membrane; and
conducting said air bubbles from said blood side of said dialyzer and removing said air bubbles from said extracorporeal circuit.

### Claim 2 (depends on 1)

The method of claim 1, wherein said extracorporeal circuit further comprises an arterial line, a venous line, a blood pump and first and second clamps placed in said arterial and venous lines respectively, and wherein said step of inducing pressure pulses comprises the steps of:
opening and closing said first and said second clamps, and
operating said blood pump to pump said fluid through said arterial and venous lines, thereby causing surges of fluid to flow through said dialyzer and remove air bubbles from said dialyzer.

### Claim 3 (depends on 1)

The method of claim 1, wherein said fluid comprises water filtered by a reverse osmosis filter and stored in an ultrafiltration tank prior to being sent to said extracorporeal circuit and filling said extracorporeal circuit.

### Claim 4 (depends on 1)

The method of claim 1, further comprising the step of periodically backflushing said dialyzer with fluid by forcing fluid from said dialysate side to said blood side of said dialyzer during said step of inducing multiple brief pressure pulses.

### Claim 5

A method of automatically priming a dialyzer in an extracorporeal circuit, said dialyzer having a membrane and a blood side thereof and a dialysate side thereof, the method performed in situ within a dialysis machine, comprising the steps of:
substantially filling said extracorporeal circuit and said blood side of said dialyzer with fluid;
inducing multiple brief pressure pulses in said extracorporeal circuit and backfiltering fluid across said membrane from said dialysate side to said blood side in synchrony with said multiple brief pressure pulses;
said multiple brief pressure pulses causing air bubbles from said blood side of said dialyzer to be sheared off the blood side of said membrane; and
conducting said air bubbles from said blood side of dialyzer and removing said air bubbles from said extracorporeal circuit.

### Claim 6 (depends on 5)

The method of claim 5, wherein said step of inducing pressure pulses comprises the steps of:
pumping dialysate through said dialysate circuit at a high flow rate; and
opening and closing a valve in fluid communication with said dialysate side of said dialyzer.
