Hemodialysis system

• US 9,724,458 B2
• Filed: 05/24/2012
• Issued: 08/08/2017
• Est. Priority Date: 05/24/2011
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Bodwell, Jesse T., Rudolf, Brett A., Collins, David E., Gustin, Lisa A., Grant, Kevin L., Wilt, Michael J., Tracey, Brian D., Dale, James D.
• Primary Examiner(s): Zalukaeva, Tatyana
• Assistant Examiner(s): KLEIN, BENJAMIN JACOB
• Application Number:
  US14/122,166
• Publication Number:
  US 20140112828A1
• Time in Patent Office: 1,902 Days
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1658 Degasification
• CPC Class Codes: A61M 1/168 Sterilisation or cleaning before or after use
• CPC Class Codes: A61M 1/1682 both machine and membrane module, i.e. also the module blood side
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/3621 Extra-corporeal blood circuits single-needle circuits A61M1/30
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• 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 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• 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 1/3647 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 1/3652 : using gas, e.g. air
• CPC Class Codes: A61M 1/3653 : Interfaces between patient blood circulation and extra-corporal blood circuit
• CPC Class Codes: A61M 1/3656 : Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 1/367 : Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 1/3672 : Means preventing coagulation
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/121 : interface between cassette and base
• CPC Class Codes: A61M 2205/128 : with incorporated valves
• CPC Class Codes: Y10T 137/87169 : Supply and exhaust

Abstract

A drain cassette for a dialysis unit has a fluid channel between venous and arterial connection ports, and a valve may controllably open and close fluid communication between a drain outlet port and the venous connection port or the arterial connection port. A blood circuit assembly and drain cassette may be removable from the dialysis unit, e.g., by hand and without the use of tools. A blood circuit assembly may include a single, unitary member that defines portions of a pair of blood pumps, control valves, channels to accurately position flexible tubing for an occluder, an air trap support, and/or other portions of the assembly. A blood circuit assembly engagement device may assist with retaining a blood circuit assembly on the dialysis unit, and/or with removal of the assembly. An actuator may operate a retainer element and an ejector element that interact with the assembly.

Claims

1. A drain cassette for a dialysis unit, comprising:

a body having a front side and a back side opposite the front side;

a venous connection port on the front side of the body for removable connection to, and fluid communication with, a venous blood line connector of a blood tubing set mounted to an exposed panel of the dialysis unit;

an arterial connection port on the front side of the body for removable connection to, and fluid communication with, an arterial blood line connector of the blood tubing set;

a fluid channel defined by the body and fluidly connecting the venous connection port and the arterial connection port for circulation of fluid between an arterial blood line and a venous blood line of the blood tubing set;

a drain outlet port in fluid communication with the fluid channel, the drain outlet port being located on the back side of the body and arranged to removably couple with a drain connector on the exposed panel; and

a valve arranged to control flow in the fluid channel,

wherein the valve is arranged to either controllably open and close fluid communication in the fluid channel between the drain outlet port and the venous connection port or to controllably open and close fluid communication in the fluid channel between the drain outlet port and the arterial connection port, wherein the drain cassette is configured such that mounting the drain cassette to the exposed panel removably couples the drain outlet port with the drain connector on the exposed panel and dismounting the drain cassette from the exposed panel uncouples the drain outlet port from the drain connector, and wherein the drain cassette is mountable to the exposed panel separate from any blood circuit assembly that includes the arterial and venous blood line connectors.

2. The drain cassette of claim 1, further comprising:

a check valve arranged to allow flow from the fluid channel and out of the drain outlet port and to resist flow from the drain outlet port to the fluid channel.

3. The drain cassette of claim 1, wherein the valve is a pneumatically-controlled valve, the cassette further comprising:

a pneumatic control port arranged to removably mate with a port on the exposed panel, the pneumatic control port being fluidly coupled to the valve to allow control of the valve by the dialysis unit.

4. The drain cassette of claim 1, further comprising:

a latch arranged to releasably lock the drain cassette to the exposed panel.

5. The drain cassette of claim 1, wherein the drain outlet port fluidly communicates with the fluid channel at a point above where the arterial and venous connection ports communicate with the fluid channel.

6. The drain cassette of claim 1, wherein the fluid channel has a U shape.

7. The drain cassette of claim 1, wherein the arterial and venous connection ports are fluidly connected to the fluid channel at ends of the U shape, and the drain outlet port is fluidly connected to the fluid channel at a central bend of the U shape.

8. The drain cassette of claim 1, further comprising:

a conductivity sensor arranged to detect a conductivity of fluid in the fluid channel.

9. The drain cassette of claim 1, further comprising:

a temperature sensor arranged to detect a temperature of fluid in the fluid channel.

10. The drain cassette of claim 1, further comprising:

an electrical connector arranged to mate with a corresponding electrical connector on the exposed panel when the drain outlet port is coupled with the drain connector.

11. The drain cassette of claim 10, further comprising:

one or more sensors arranged to detect a characteristic of fluid in the fluid channel, the one or more sensors being connected to the electrical connector.

12. The drain cassette of claim 1, further comprising:

one or more sensors arranged to detect a characteristic of fluid in the fluid channel; and

an electrical connector arranged to electrically connect the one or more sensors to a corresponding electrical connector on the exposed panel,

wherein the electrical connector and the drain outlet port are arranged to simultaneously couple with a corresponding electrical connector and drain connector on the exposed panel of the dialysis unit in a single connection operation.

13. The drain cassette of claim 12, wherein the valve is a pneumatically-controlled valve, the cassette further comprising:

a pneumatic control port arranged to removably mate with a control port on the exposed panel, wherein the pneumatic control port is arranged to simultaneously couple with the corresponding control port in the single connection operation.

14. The drain cassette of claim 1, wherein the drain outlet port is in permanently open fluid communication with the arterial connection port, and the valve is arranged to controllably open and close fluid communication in the fluid channel between the drain outlet port and the venous connection port.

15. The drain cassette of claim 1, wherein the drain outlet port is in permanently open fluid communication with the venous connection port, and the valve is arranged to controllably open and close fluid communication in the fluid channel between the drain outlet port and the arterial connection port.

16. A blood circuit assembly and drain cassette for a dialysis unit, the blood circuit assembly comprising:

a pair of pneumatic pumps for circulating blood received from a patient through a circuit including a dialyzer unit and returned to the patient, the pneumatic pumps having pneumatic control ports arranged for alignment and mating with corresponding ports located on an exposed panel of the dialysis unit by pushing the control ports into engagement with the corresponding ports with mounting of the blood circuit assembly to the exposed panel;

an air trap arranged to remove air from blood circulating in the circuit;

a pair of dialyzer connections arranged to connect to the inlet and outlet of a dialyzer unit; and

a pair of blood line connectors, including an arterial blood line connector and arterial tubing for receiving blood from the patient and providing blood to the pneumatic pumps and a venous blood line connector and venous tubing for returning blood to the patient;

the drain cassette comprising;

a body having a front side and a back side opposite the front side;

a venous connection port on the front side of the body for removable connection to, and fluid communication with, the venous blood line connector;

an arterial connection port on the front side of the body for removable connection to, and fluid communication with, the arterial blood line connector;

a fluid channel defined by the body and fluidly connecting the venous connection port and the arterial connection port for circulation of fluid between the arterial and venous tubing of the blood circuit assembly;

a drain outlet port in fluid communication with the fluid channel, the drain outlet port being located on the back side of the body and arranged to removably couple with a drain connector on an exposed panel of the dialysis unit; and

a valve arranged to control flow in the fluid channel,

wherein the drain cassette is configured such that mounting the drain cassette to the exposed panel removably couples the drain outlet port with the drain connector on the exposed panel and dismounting the drain cassette from the exposed panel uncouples the drain outlet port from the drain connector, and wherein both the blood circuit assembly and the drain cassette are separately engageable with the exposed panel for operation in a dialysis treatment, and are removable from the exposed panel for replacement, without the use of tools.

17. The assembly and cassette of claim 16, further comprising flexible tubing fluidly connecting the pumps, the air trap, the dialyzer connections and the blood line connectors.

18. The assembly and cassette of claim 17, wherein the flexible tubing fluidly connects the arterial blood line connector to an inlet for a pump cassette, an outlet for the pump cassette to a dialyzer inlet connector, a dialyzer outlet connector to an inlet of the air trap, and an outlet of the air trap to the venous blood line connector.

19. The assembly and cassette of claim 16, wherein the blood line connectors are arranged for a threaded luer-type connection to a patient access, and are arranged for a press-in type connection to the drain cassette connection ports.

20. The assembly and cassette of claim 16, further comprising:

a check valve arranged to allow flow from the fluid channel and out of the drain outlet port and to resist flow from the drain outlet port to the fluid channel.

21. The assembly and cassette of claim 16, wherein the valve of the drain cassette is a pneumatically-controlled valve, the drain cassette further comprising:

a pneumatic control port arranged to removably mate with a port on the exposed panel and fluidly coupled to the valve to allow control of the valve.

22. The assembly and cassette of claim 16, further comprising:

a latch arranged to releasably lock the drain cassette to the exposed panel.

23. The assembly and cassette of claim 16, wherein the drain outlet port fluidly communicates with the fluid channel at a point above where the arterial and venous connection ports communicate with the fluid channel.

24. The assembly and cassette of claim 16, the drain cassette further comprising:

one or more sensors arranged to detect a characteristic of fluid in the fluid channel; and

an electrical connector arranged to electrically connect the one or more sensors to a corresponding electrical connector on the exposed panel,

wherein the electrical connector and the drain outlet port are arranged to simultaneously couple with a corresponding electrical connector and drain connector on the exposed panel in a single connection operation.

25. The assembly and cassette of claim 24, wherein the valve is a pneumatically-controlled valve, the drain cassette further comprising:

a pneumatic control port arranged to removably mate with a control port on the exposed panel, wherein the pneumatic control port is arranged to simultaneously couple with the corresponding control port in the single connection operation.