Hemodialysis systems and methods

• US 10,449,280 B2
• Filed: 12/21/2016
• Issued: 10/22/2019
• 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:
  US15/386,546
• Publication Number:
  US 20170100533A1
• Time in Patent Office: 1,035 Days
• 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 blood is drawn from a patient and passed through a dialyzer;

the blood flow path comprising a pump cassette that includes at least one pneumatically actuated diaphragm-based blood pump for pumping blood;

the pump cassette including a pneumatically actuated diaphragm-based medication pump for pumping medication into the blood flow path;

the medication pump being in valved connection with an air vent on the pump cassette; and

a controller for controlling pneumatic actuation pressure delivered to the blood pump, medication pump and one or more diaphragm-based valves that connect the blood pump, medication pump and air vent to the blood flow path;

wherein the hemodialysis system is configured to actuate the blood pump or medication pump, and the one or more valves to introduce air into the blood flow path and expel liquid from the blood flow path to a drain.

2. The hemodialysis system of claim 1, wherein the at least one blood pump comprises a first and a second blood pump, and wherein the hemodialysis system is configured to actuate the first blood pump to pump air through a venous line and a dialyzer of the blood flow path to drain, and to actuate the second blood pump to pump air through an arterial line of the blood flow path to drain.

3. The hemodialysis system of claim 1, wherein the medication pump is an anticoagulant pump.

4. The hemodialysis system of claim 1, wherein the medication pump is connected to three fluid valves, the first fluid valve connected to a first flowpath in the pump cassette for connection to a medication vial, the second fluid valve connected a second flowpath in the pump cassette to the air vent, and the third fluid valve connected to a third flowpath in the pump cassette for connection to the blood flow path.

5. The hemodialysis system of claim 4, wherein the medication pump is configured to pump medication from a medication vial to the blood flow path, and to pump air from the air vent to the medication vial.

6. The hemodialysis system of claim 1, wherein the air vent includes an air filter.

7. The hemodialysis system of claim 6, wherein the air filter is a hydrophobic air filter.

8. A hemodialysis system, comprising:

a pump cassette comprising a pair of pneumatically actuated diaphragm-based main pumps, each said main pump having an inlet in valved connection with a cassette inlet, and an outlet in valved connection with a cassette outlet;

the pump cassette further comprising a pneumatically actuated diaphragm-based metering pump, the metering pump having a first valved connection with an air vent on the pump cassette, a second valved connection with a medication port of the pump cassette, and a third valved connection with the outlet or inlet of the pump cassette;

the pump cassette further comprising a plurality of pneumatically actuated diaphragm-based valves, said valves comprising the valved connections of the main pumps and of the metering pump; and

a controller configured to control pneumatic pressure delivered to the main pumps, the metering pump, and the plurality of valves, to actuate the metering pump to pump air from the air vent to the inlet or outlet of the pump cassette in order to drain fluid out of one or more fluid lines connected to the pump cassette.

9. The hemodialysis system of claim 8, wherein the controller is configured to control pneumatic pressure delivered to the main pumps, the metering pump and the plurality of valves, to actuate the metering pump to pump air from the air vent to a first one of the pair of main pumps, and to actuate the first one of the pair of main pumps to pump air to the inlet or outlet of the pump cassette.

10. The hemodialysis system of claim 8, wherein the controller is configured to control pneumatic pressure delivered to the main pumps, the metering pump and the plurality of valves, to actuate the metering pump to pump air from the air vent to a first one of the pair of main pumps and to pump air from the air vent to a second one of the pair of main pumps, and to actuate the first one of the main pumps to pump air to the inlet of the pump cassette, and to actuate the second one of the main pumps to pump air to the outlet of the pump cassette.

11. The hemodialysis system of claim 8, wherein the controller is configured to control pneumatic pressure delivered to the main pumps, the metering pump and the plurality of valves, to actuate the metering pump to pump air from the air vent to the medication port of the pump cassette.

12. The hemodialysis system of claim 11, wherein the medication port is configured for connection to an anticoagulant container, and the inlet and outlet of the pump cassette are configured for connection to a blood flow path of the hemodialysis system.

13. A hemodialysis system comprising:

a pump cassette comprising;

a pair of pneumatically actuated diaphragm-based main pumps, each said main pump having an inlet in valved connection with a cassette inlet, and an outlet in valved connection with a cassette outlet;

a pneumatically actuated diaphragm-based metering pump, the metering pump having a first valved connection with an air vent on the pump cassette, a second valved connection with a medication port of the pump cassette, and a third valved connection with the outlet or inlet of the pump cassette;

a plurality of pneumatically actuated diaphragm-based valves, a first valve interposed between a first one of the pair of main pumps and the cassette inlet, a second valve interposed between a second one of the pair of main pumps and the cassette inlet, a third valve interposed between the first one of the pair of main pumps and the cassette outlet, a fourth valve interposed between the second one of the pair of main pumps and the cassette outlet, a fifth valve interposed between the metering pump and the air vent, a sixth valve interposed between the metering pump and the medication port, and a seventh valve interposed between the metering pump and the cassette inlet or outlet; and

a controller configured to control pneumatic pressure delivered to the main pumps, the metering pump, and the first through seventh valves, to actuate the metering pump to pump air from the air vent to the inlet or outlet of the pump cassette in order to drain fluid out of one or more fluid lines connected to the pump cassette.

14. The hemodialysis system of claim 13, wherein the controller is configured to control pneumatic pressure delivered to the main pumps, the metering pump and the first through seventh valves, to actuate the metering pump to pump air from the air vent to a first one of the pair of main pumps, and to actuate the first one of the pair of main pumps to pump air to the inlet or outlet of the pump cassette.

15. The hemodialysis system of claim 13, wherein the controller is configured to control pneumatic pressure delivered to the main pumps, the metering pump and the first through seventh valves, to actuate the metering pump to pump air from the air vent to a first one of the pair of main pumps and to pump air from the air vent to a second one of the pair of main pumps, and to actuate the first one of the main pumps to pump air to the inlet of the pump cassette, and to actuate the second one of the main pumps to pump air to the outlet of the pump cassette.

16. The hemodialysis system of claim 13, wherein the controller is configured to control pneumatic pressure delivered to the main pumps, the metering pump and the first through seventh valves, to actuate the metering pump to pump air from the air vent to the medication port of the pump cassette.

17. The hemodialysis system of claim 16, wherein the medication port is configured for connection to an anticoagulant container, and the inlet and outlet of the pump cassette are configured for connection to a blood flow path of the hemodialysis system.