Lightweight noncompliant dialysate solution tank for batch dialysate preparation systems

• US 5,783,072 A
• Filed: 04/23/1997
• Issued: 07/21/1998
• 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., Pawlak, Kenneth E.
• Primary Examiner(s): Kim, John
• Application Number:
  US08/842,184
• Time in Patent Office: 454 Days
• Field of Search: 210/321.65, 210/321.71, 210/257.1, 210/195.2, 220/414, 220/454, 220/455, 220/457, 220/588, 220/589, 422/102, 604/29
• US Class Current: 210/195.2
• 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 dialysis machine is described which has a batch dialysate preparation system comprising a lightweight, substantially noncompliant dialysate tank and volumetrically closed dialysate circuit. The tank is made from a polymeric material, such as polypropylene, with fiberglass windings on the exterior of the tank. The noncompliance of the tank and dialysate circuit allows for greater control over ultrafiltration of the patient.

Claims

1. A hemodialysis machine having a substantially noncompliant dialysate circuit, said hemodialysis machine comprising:

a dialyzer;

a lightweight substantially noncompliant batch quantity dialysate solution tank comprising;

a hollow vessel made from a polymeric material, said vessel reinforced with fibers wound around said vessel, increasing the rigidity of said vessel;

said vessel having a fluid inlet and a fluid outlet and a port for receiving dialysate chemicals from a source of dialysate chemicals; and

a closed fluid circuit circulating a dialysate solution stored in said tank from said tank to said dialyzer and back to said tank.

2. The hemodialysis machine of claim 1, wherein said tank is made from polypropylene.

3. The hemodialysis machine of claim 1, wherein said fibers comprise fiberglass.

4. The hemodialysis machine of claim 1, wherein said fibers comprise composite fibers.

5. The hemodialysis machine of claim 1, wherein said fibers comprise carbon fibers.

6. The hemodialysis machine of claim 1, wherein said tank is made from polyvinylidene fluoride.

7. The hemodialysis machine of claim 1, further comprising an ultrafiltration tank in fluid communication with said dialysate circuit and a means for removing fluid from said dialysate circuit and directing said fluid into said ultrafiltration tank.

8. The hemodialysis machine of claim 1, wherein said tank further comprises a closed, rigid chemical loading compartment mounted to said tank adjacent to said port for receiving dialysate chemicals.

9. A hemodialysis machine suitable for use in a home environment having a substantially noncompliant dialysate circuit, said hemodialysis machine comprising:

a dialyzer;

a lightweight substantially noncompliant batch quantity dialysate solution tank comprising;

a hollow vessel made from a lightweight, biocompatible, sterilizeable polymeric material compatible with dialysate solution chemicals, said vessel reinforced with fibers wound around said vessel to increase the rigidity of the vessel;

said vessel further comprising a fluid inlet and a fluid outlet and a port for receiving dialysate chemicals from a source of said dialysate chemicals

a volumetrically closed fluid circuit circulating a dialysate solution stored in said tank from said tank to said dialyzer and back to said tank; and

an ultrafiltration tank in fluid communication with said volumetrically closed fluid circuit and means for removing dialysate solution from said volumetrically closed fluid circuit and delivering said removed dialysate solution to said ultrafiltration tank,

whereby said substantial noncompliance of said tank promotes the effective control of the volume of dialysate solution removed from said volumetrically closed fluid circuit.

10. The hemodialysis machine of claim 9, further comprising a closed, rigid chemical loading compartment mounted to said tank adjacent to said port for receiving dialysate chemicals.

11. A peritoneal dialysis machine suitable for use in the home environment, comprising:

a cycler supplying dialysate solutions to a patient;

a lightweight substantially noncompliant batch quantity dialysate solution tank comprising;

a hollow vessel made from a lightweight, biocompatible, sterilizeable polymeric material compatible with dialysate solution chemicals, said vessel reinforced with fibers wound around said vessel to increase the rigidity of the vessel, said vessel further comprising a fluid inlet and a fluid outlet and a port for receiving dialysate chemicals from a source of said dialysate chemicals; and

a volumetrically closed fluid circuit circulating a dialysate solution stored in said tank from said tank to said cycler.

12. A lightweight hemodialysis machine having a noncompliant dialysate circuit, comprising:

an extracorporeal circuit for receiving blood from a patient and circulating said blood to a blood side of a dialyzer, said dialyzer also having a dialysate side;

a volumetrically closed dialysate circuit for circulating a dialysate solution to said dialysate side of said dialyzer; and

a substantially noncompliant tank for supplying said dialysate solution to said dialysate circuit and for mixing a batch of dialysate and storing said batch of dialysate during a dialysis session of said patient, the tank having a fluid inlet and a fluid outlet and chemical introduction port;

said tank further comprising a hollow vessel made from a lightweight, sterilizeable and biocompatible polymeric material, said vessel reinforced with fibers wound about said vessel, increasing the rigidity of said vessel;

a closed rigid chemical loading platform mounted to the side of said tank opposite to said port for receiving chemicals from a source of said chemicals and introducing said chemicals into said tank; and

a pump for pumping said dialysate solution from said tank through said dialysate circuit.

13. The machine of claim 12, wherein said tank is made from polypropylene.

14. The machine of claim 12, wherein said fibers comprise fiberglass.

15. The machine of claim 12, wherein said fibers comprise composite fibers.

16. The machine of claim 12, wherein said fibers comprise carbon fibers.