Hemodialysis systems and methods

• US 8,721,884 B2
• Filed: 08/08/2012
• Issued: 05/13/2014
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Wilt, Michael J., Demers, Jason A., Grant, Kevin L., Tracey, Brian D., Dale, James D.
• Primary Examiner(s): Kim, John
• Application Number:
  US13/569,623
• Publication Number:
  US 20130032536A1
• Time in Patent Office: 643 Days
• Field of Search: 210/106, 210/108, 210/232, 210/252, 210/257.1, 210/257.2, 210/258, 210/321.6, 210/321.69, 210/333.01, 210/391, 210/393, 210/408, 210/416.1, 210/427, 417/286, 417/375, 604/4.01, 604/5.01, 604/5.04, 604/6.1, 604/6.11
• US Class Current: 210/258
• 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 1/1561 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 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1621 Constructional aspects thereof semi-permeable membranes for separation processes characterised by their properties B01D69/00; semi permeable membranes characterised by their material B01D71/00
• CPC Class Codes: A61M 1/1654 Dialysates therefor
• CPC Class Codes: A61M 1/1694 with recirculating dialysing liquid
• CPC Class Codes: A61M 1/267 used for pumping
• CPC Class Codes: A61M 1/3401 Cassettes therefor
• CPC Class Codes: A61M 1/341 by measuring the filtrate rate or volume
• CPC Class Codes: A61M 1/3413 Diafiltration
• CPC Class Codes: A61M 1/3424 Substitution fluid path
• 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 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/362261 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 1/362263 : Details of incorporated filters
• 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 1/3623 : Means for actively controlling temperature of blood
• CPC Class Codes: A61M 1/3638 : with a vapour trap
• 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 1/3649 : 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 1/3652 : using gas, e.g. air
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/07 : having air pumping means
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/123 : with incorporated reservoirs
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: A61M 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/16 : with back-up system in case of failure
• 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 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/82 : Internal energy supply devices
• CPC Class Codes: A61M 2205/8218 : Gas operated
• CPC Class Codes: A61M 2205/8225 : using incorporated gas cartridges for the driving gas
• CPC Class Codes: Y10T 137/87893 : With fluid actuator

Abstract

Disclosed are hemodialysis and similar dialysis systems including fluid flow circuits. Hemodialysis systems may include a blood flow path, and a dialysate flow path including balancing, mixing, and/or a directing circuits. Preparation of dialysate may be decoupled from patient dialysis. Circuits may be defined within one or more cassettes. The fluid circuit and/or the various fluid flow paths may be isolated from electrical components. A gas supply may be provided that, when activated, is able to urge dialysate through the dialyzer and blood back to the patient. Such a system may be useful during a power failure. The hemodialysis system may also include fluid handling devices, such as pumps, valves, mixers, etc., actuated using a control fluid. The control fluid may be delivered to the fluid handling devices using a detachable external pump. The fluid handling devices may have a spheroid shape with a diaphragm dividing it into two compartments.

Claims

1. A hemodialysis system, comprising:

a blood flow path through which untreated blood is drawn from a patient, passed through a dialyzer, and returned to the patient;

one or more dialysate flow paths through which dialysate flows to or from the dialyzer, the dialyzer permitting dialysate to pass from the dialysate flow path to the blood flow path;

a gas supply in fluidic communication with the dialysate flow path, and

a valve interposed between the gas supply and the dialysate flow path, wherein

the system is configured to allow the valve to open upon loss of electrical power to the system to introduce a gas supplied by the gas supply into the system to displace dialysate in the dialysate flow path through the dialyzer and into the blood flow path to urge blood in the blood flow path back to the patient.

2. The hemodialysis system of claim 1, wherein the gas supply is an air supply.

3. The hemodialysis system of claim 1, wherein the blood flow path is comprises a blood flow cassette.

4. The hemodialysis system of claim 3, wherein the blood flow cassette comprises a pod pump.

5. The hemodialysis system of claim 4, wherein the pod pump comprises:

a rigid curved wall defining a pumping volume and having an inlet and an outlet;

a pump diaphragm mounted within the pumping volume; and

an actuation port for connecting the pod pump to a pneumatic actuation system so that the diaphragm can be actuated to urge fluid into and out of the pumping volume, wherein the pump diaphragm separates the fluid from a gas in fluid communication with the pneumatic actuation system.

6. The hemodialysis system of claim 5, wherein the rigid curved wall defines a substantially spherical volume.

7. The hemodialysis system of claim 3, wherein the blood flow cassette comprises a spike integrally formed with the cassette, the spike able to receive a vial of fluid.

8. The hemodialysis system of claim 7, wherein the spike is hollow.

9. The hemodialysis system of claim 3, wherein the blood flow cassette is fluidically connectable to a first source of positive pneumatic pressure.

10. The hemodialysis system of claim 9, wherein the blood flow cassette is fluidically connectable to a second source of pneumatic pressure whose supply pressure is lower than a supply pressure of the first source of positive pneumatic pressure.

11. The hemodialysis system of claim 10, wherein the second source is a negative pressure source.

12. The hemodialysis system of claim 1, wherein the dialysate flow path comprises at least one cassette.

13. The hemodialysis system of claim 12, wherein the dialysate flow path comprises at least two cassettes.

14. The hemodialysis system of claim 12, wherein the two cassettes are immobilized relative to each other.

15. The hemodialysis system of claim 12, wherein the two cassettes are in fluid communication.

16. The hemodialysis system of claim 12, wherein the dialysate flow path comprises at least three cassettes.

17. The hemodialysis system of claim 12, further comprising a conduit connectable between the two cassettes.

18. The hemodialysis system of claim 1, wherein the blood flow path comprises an aeterial tube having an end configured for accessing an artery of the patient and a venous tube having an end configured for accessing a vein of the patient, and wherein the blood flow path is configured so that untreated blood drawn from the patient through the end of the arterial tube is passed through the dialyzer and returned to the patient through the end of the venous tube.

19. The hemodialysis system of claim 18, wherein the the system is configured to allow the valve to open upon loss of electrical power to the system to introduce the gas supplied by the gas supply into the dialysate flow path to displace dialysate in the dialysate flow path through the dialyzer and into the blood flow path towards the end of the arterial tube and the end of the venous tube to urge blood in the blood flow path back to the patient.

20. The hemodialysis system of claim 1, wherein the gas supply comprises a reservoir of compressed air.

21. The hemodialysis system of claim 1, wherein the valve is configured for manual actuation.

22. The hemodialysis system of claim 1, further comprising one or more isolating valves configured to close the one or more dialysate flow paths during a power failure condition.

23. The hemodialysis system of claim 18, wherein the arterial tube of the blood flow path comprises an arterial line clamp capable of stopping fluid flow through the arterial tube, and the venous tube of the blood flow path comprises a venous line clamp capable of stopping fluid flow through the venous tube.