Disinfection of arterial and venous line connectors hemodialysis machine

• US 5,714,060 A
• Filed: 09/04/1996
• Issued: 02/03/1998
• Est. Priority Date: 02/13/1995
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Aksys Ltd.
• Inventors: Treu, Dennis M., Kenley, Rodney S., Adolf, Wayne F., Pawlak, Kenneth E., Peter, Frederick H. Jr., Feldsein, Thomas M.
• Primary Examiner(s): Kim, John
• Application Number:
  US08/707,509
• Time in Patent Office: 517 Days
• Field of Search: 210/194, 210/195.1, 210/195.2, 210/232, 210/240, 210/636, 210/764, 422/1
• US Class Current: 210/194
• CPC Class Codes: A61L 2/04 Heat A61L2/08 takes precedence
• CPC Class Codes: A61L 2/18 Liquid substances or solutions comprising solids or dissolved gases
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1607 before use, i.e. upstream of dialyser
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1649 with pulsatile dialysis fluid flow
• CPC Class Codes: A61M 1/165 with a dialyser bypass on the dialysis fluid line
• 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 1/1662 with heat exchange between fresh and used dialysate
• CPC Class Codes: A61M 1/1666 by dissolving solids
• CPC Class Codes: A61M 1/1668 Details of containers
• CPC Class Codes: A61M 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1684 Checking the module characteristics before reuse
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/1688 with recirculation of the sterilising fluid
• CPC Class Codes: A61M 1/169 using chemical substances
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1694 : with recirculating dialysing liquid
• CPC Class Codes: A61M 1/288 : Priming priming in extracorporeal blood circuits A61M1/3643
• CPC Class Codes: A61M 1/3434 : with pre-dilution and post-dilution
• CPC Class Codes: A61M 1/3437 : downstream of the filter, e.g. post-dilution with filtrate
• CPC Class Codes: A61M 1/3465 : using dialysate as substitution fluid
• CPC Class Codes: A61M 1/3468 : using treated filtrate as substitution fluid
• CPC Class Codes: A61M 1/3609 : Physical characteristics of the blood, e.g. haematocrit, urea
• CPC Class Codes: A61M 1/3622 : with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/36224 : with sensing 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 1/362263 : Details of incorporated filters
• CPC Class Codes: A61M 1/3626 : Gas bubble detectors
• CPC Class Codes: A61M 1/3627 : Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/3629 : degassing by changing pump speed, e.g. during priming
• CPC Class Codes: A61M 1/3639 : Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 : Pressure isolators
• CPC Class Codes: A61M 1/3643 : Priming, rinsing before or after use
• CPC Class Codes: A61M 1/3644 : Mode of operation
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3647 : with recirculation of the priming solution
• CPC Class Codes: A61M 1/3649 : using dialysate as priming or rinsing liquid
• CPC Class Codes: A61M 1/365 : through membranes, e.g. by inverted trans-membrane pressure [TMP]
• 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 2205/17 : with redundant control systems
• CPC Class Codes: A61M 2205/18 : with alarm
• 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 2205/3344 : Measuring or controlling pressure at the body treatment site
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3382 : Upper level detectors
• CPC Class Codes: A61M 2205/3386 : Low level detectors
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/6072 : Bar codes
• CPC Class Codes: A61M 2205/705 : Testing of filters for leaks blood in dialysate A61M1/1692
• CPC Class Codes: A61M 2205/707 : Testing of filters for clogging
• CPC Class Codes: A61M 2205/7554 : with means for unclogging or regenerating filters
• CPC Class Codes: A61M 2205/7581 : with means for switching over to a fresh filter on clogging or saturation
• CPC Class Codes: A61M 2206/11 : Laminar flow
• CPC Class Codes: A61M 2230/65 : Impedance, e.g. conductivity, capacity
• CPC Class Codes: A61M 39/16 : having provision for disinfection or sterilisation A61M39/143 takes precedence; methods or apparatus for disinfection or sterilisation A61L2/00
• CPC Class Codes: B01D 2311/04 : Specific process operations in the feed stream; Feed pretreatment
• CPC Class Codes: B01D 2311/10 : Temperature control
• CPC Class Codes: B01D 2311/25 : Recirculation, recycling or bypass, e.g. recirculation of concentrate into the feed
• CPC Class Codes: B01D 2311/2626 : Absorption or adsorption
• CPC Class Codes: B01D 2321/04 : Backflushing
• CPC Class Codes: B01D 2321/16 : Use of chemical agents
• CPC Class Codes: B01D 2321/32 : By heating or pyrolysis
• CPC Class Codes: B01D 61/02 : Reverse osmosis; Hyperfiltration ; Nanofiltration
• CPC Class Codes: B01D 61/025 : Reverse osmosis; Hyperfiltration
• CPC Class Codes: B01D 61/04 : Feed pretreatment
• CPC Class Codes: B01D 61/12 : Controlling or regulating
• CPC Class Codes: B01D 61/32 : Controlling or regulating
• CPC Class Codes: B01D 65/022 : Membrane sterilisation
• CPC Class Codes: B01D 65/102 : Detection of leaks in membranes
• CPC Class Codes: B01D 65/104 : Detection of leaks in membrane apparatus or modules
• CPC Class Codes: C02F 1/441 : by reverse osmosis
• CPC Class Codes: F16K 17/0453 : the member being a diaphragm
• CPC Class Codes: Y10S 210/929 : Hemoultrafiltrate volume measurement or control processes
• CPC Class Codes: Y10S 215/03 : Medical
• CPC Class Codes: Y10T 137/7722 : Line condition change responsive valves
• CPC Class Codes: Y10T 137/7794 : With relief valve
• CPC Class Codes: Y10T 137/7796 : Senses inlet pressure
• CPC Class Codes: Y10T 137/7799 : Liquid transfer

Abstract

A hemodialysis machine has ports of a disinfection manifold for receiving the arterial and venous line connectors terminating the arterial and venous lines. The ports are in fluid communication with a hydraulic system that circulates disinfection fluid through the machine including the extracorporeal circuit. The ports are constructed so as to provide a gap extending circumferentially around the arterial and venous line connectors. When the disinfection fluid circulates through the ports of the disinfection manifold, the fluid circulates around the external surfaces of the connectors as well as through the internal fluid passages, thereby insuring a complete disinfection of the connectors.

Claims

1. Apparatus for establishing fluid connection between an extracorporeal circuit and a source of disinfection fluids, said extracorporeal circuit comprising a dialyzer, an arterial blood line having an arterial blood line connector at the end thereof having an exterior surface and a first diameter and a venous blood line having a venous blood line connector at the end thereof having an exterior surface and a second diameter, comprising:

a disinfection line for carrying disinfection fluid from said source of disinfection fluids to said extracorporeal circuit;

a disinfection manifold comprising a first port and a second port;

said first port for receiving therein said arterial line connector, said second port for receiving therein said venous line connector;

said first and second ports each comprising an interior wall constructed with an internal dimension greater than said first and second diameters of said arterial and venous line connectors, respectively, by an amount sufficient so as to provide a circumferential space around said exterior surfaces of said arterial and venous line connectors when said arterial and venous line connectors are received in said first and second ports of said disinfection manifold, respectively so as to allow fluid to circulate around said exterior surface of said arterial and venous line connectors when said arterial and venous line connectors are installed in said first and second ports;

a return line establishing a fluid connection with said disinfection manifold and said source of disinfection fluids from said extracorporeal circuit;

whereby disinfection fluids passed into said disinfection manifold by said disinfection line are routed through said arterial and venous blood lines and out of said extracorporeal circuit via said return line, achieving disinfection of said arterial and venous lines and disinfection of said exterior surfaces of said arterial and venous line connectors.

2. The apparatus of claim 1, wherein said disinfection fluid comprises water heated to a predetermined high level disinfection temperature.

3. The apparatus of claim 1, wherein said disinfection manifold further comprises a third port receiving said disinfection line, wherein said third port is in fluid communication with at least one of said second ports.

4. The apparatus of claim 3 wherein said disinfection fluid comprises water heated to a temperature of at least about 80 degrees C.

5. Apparatus for directing disinfection fluids to and from an extracorporeal circuit, said extracorporeal circuit comprising an arterial blood line having an arterial blood line connector at the end thereof and having an exterior surface and a first diameter and a venous blood line having a venous blood line connector at the end thereof having an exterior surface and a second diameter, comprising:

first, second and third ports, said first and second ports adapted for receiving therein said arterial and venous line connectors, respectively;

said first and second ports each comprising an interior wall constructed with an internal dimension greater than said first and second diameters of said arterial and venous line connectors, respectively, by an amount sufficient so as to provide a circumferential space around said exterior surfaces of said arterial and venous line connectors when said arterial and venous line connectors are received in said first and second ports, respectively so as to allow fluid to circulate around said exterior surface of said arterial and venous line connectors when said arterial and venous line connectors are installed in said first and second ports;

fluid passages establishing fluid connection between said first and second ports; and

said third port having means for receiving a disinfection line for containing a disinfection fluid;

said disinfection line in fluid communication with at least one of said first or said second port, the other of said first and second ports in fluid communication with a line for conveying disinfection fluid circulated through said arterial venous lines out of said extracorporeal circuit.

6. Apparatus for disinfecting the arterial and venous blood lines of a dialysis machine, said arterial and venous blood lines terminating in arterial and venous line connectors, respectively, said arterial and venous line connectors having a locking hub portion with an exterior surface thereof manually manipulable by a patient to connect with the patient'"'"'s circulatory system, comprising:

a) a hydraulic system for circulating disinfection fluids through said dialysis machine;

b) an arterial disinfection port and a venous disinfection port in fluid communication with said hydraulic system and adapted to receive said arterial and venous line connectors, respectively from said patient after termination of a dialysis session of said machine;

c) said arterial and venous disinfection ports each comprising an interior wall portion defining a interior recessed region with said exterior surface of said locking hub portion of said arterial and venous line connectors disposed within said interior recessed region when said arterial and venous line connectors are received in said arterial and venous disinfection ports, respectively;

d) said interior wall portion and interior recessed region of said arterial and venous disinfection ports constructed so as to provide a gap region extending circumferentially around said exterior surface of said locking hub portion of said arterial and venous line connectors, respectively, when said arterial and venous line connectors are received by said arterial and venous disinfection ports;

whereby the flow of disinfection fluids through said arterial and venous disinfection ports during disinfection of said machine may flow around and through said arterial and venous arterial and venous line connectors, including around said exterior surface of said locking hub portion of said arterial and venous line connectors, to thereby thoroughly disinfect said arterial and venous line connectors.

7. The apparatus of claim 6, wherein said disinfection fluid comprises water heated to at least about 80 degrees C.

8. The apparatus of claim 6, wherein said arterial and venous disinfection ports further comprise a sealing means circumferentially disposed within said recessed region of said arterial and venous disinfection ports for sealing said arterial and venous line connectors when said arterial and venous line connectors are inserted into said ports, respectively, to thereby prevent said disinfection fluid from escaping from said arterial and venous disinfection ports during disinfection of said arterial and venous line connectors.