Blood circuit assembly for a hemodialysis system

• US 9,028,691 B2
• Filed: 08/27/2008
• Issued: 05/12/2015
• Est. Priority Date: 02/27/2007
• Status: Active Grant

• Current Assignee: Deka Products Limited Partnership
• Original Assignee: Deka Products Limited Partnership
• Inventors: Grant, Kevin L., Dale, James D., Wilt, Michael J., Demers, Jason A., Collins, David E., Tracey, Brian D.
• Primary Examiner(s): FORTUNA, ANA M
• Application Number:
  US12/199,077
• Publication Number:
  US 20090105629A1
• Time in Patent Office: 2,449 Days
• Field of Search: 210/232, 210/645, 210/321.71, 210/85, 210/209, 604/6.13, 604/113, 604/4.1, 604/5.1, 604/6.6, 604/5.02, 604/6.08, 607/106, 165/122, 165/134.1, 417/38
• US Class Current: 210/321.71
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1601 Control or regulation
• CPC Class Codes: A61M 1/1633 with more than one dialyser unit
• CPC Class Codes: A61M 1/1639 linked by membranes
• CPC Class Codes: A61M 1/1652 Holding or locking systems for the membrane unit
• CPC Class Codes: A61M 1/1656 Apparatus for preparing dialysates
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1668 Details of containers
• 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 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/3607 Regulation parameters
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• 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 1/3627 Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
• CPC Class Codes: A61M 1/842 rotating continuously rotating surgical cutting instruments A61B17/32002
• CPC Class Codes: A61M 1/85 with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208
• 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 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/58 : Means for facilitating use, e.g. by people with impaired vision
• CPC Class Codes: A61M 2209/08 : Supports for equipment
• CPC Class Codes: A61M 39/1011 : Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• CPC Class Codes: A61M 39/105 : Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• CPC Class Codes: A61M 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/268 : the displacement member being flexible, e.g. membranes, diaphragms or bladders
• CPC Class Codes: A61M 60/37 : Haemodialysis, haemofiltration or diafiltration
• CPC Class Codes: A61M 60/427 : the force acting on the blood contacting member being hydraulic or pneumatic
• CPC Class Codes: A61M 60/523 : using blood flow data, e.g. from blood flow transducers
• CPC Class Codes: A61M 60/546 : of blood flow, e.g. by adapting rotor speed
• CPC Class Codes: B01D 61/30 : Accessories; Auxiliary operation
• CPC Class Codes: B01D 61/32 : Controlling or regulating

Abstract

A blood circuit assembly for a dialysis unit may include an organizing tray, a pair of pneumatic pumps mounted to the organizing tray for circulating blood received from a patient through a circuit including a dialyzer unit and returned to the patient, an air trap mounted to the organizing tray 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, one inlet blood line connector for receiving blood from the patient and providing blood to the pneumatic pumps and the other outlet blood line connector for returning blood to the patient.

Claims

1. A blood circuit assembly for a dialysis unit, comprising:

an organizing tray;

a pair of pneumatic pumps mounted to the organizing tray for circulating blood received from a patient through a circuit including a dialyzer unit and returned to the patient, the pneumatic pumps each having a rigid chamber that defines an enclosed space in which a flexible diaphragm is positioned to divide the enclosed volume into a pumping compartment and a control compartment, the control compartment including a pneumatic control port exposed on the rigid chamber in communication with the control compartment and arranged for alignment and direct mating with a corresponding port located on a front panel of the dialysis unit so that pneumatic control can be applied by the dialysis unit to the pneumatic control port to control operation of the pneumatic pump, each pneumatic control port configured to directly mate with a corresponding port on the front panel by pushing the control ports into engagement with the corresponding ports upon mounting of the blood circuit assembly to the front panel, and configured to disengage from the corresponding ports by pulling the pneumatic pumps away from the front panel of the dialysis unit;

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

first and second dialyzer connectors arranged to connect to the inlet and outlet, respectively, of a dialyzer unit;

first and second blood line connectors, the first blood line connector for receiving blood from the patient and providing blood to the pneumatic pumps and the second blood line connector for returning blood to the patient; and

tubing attached to the organizing tray, a first section of the tubing fluidly connecting an outlet of the pneumatic pumps to the first dialyzer connector, a second section of the tubing fluidly connecting an inlet of the air trap to the second dialyzer connector, a third section of the tubing fluidly connecting an inlet of the pneumatic pumps to the first blood line connector, and a fourth section of the tubing fluidly connecting an outlet of the air trap to the second blood line connector;

the organizing tray including tube engagement members configured to hold the third section of tubing extending from the inlet of the pneumatic pumps and the fourth section of tubing extending from the outlet of the air trap, and arranged to place the third and fourth sections of tubing in alignment for mounting in a tubing occluder on the front panel of the dialysis unit.

2. The blood circuit assembly of claim 1, further comprising an anticoagulant connection for engaging with an anticoagulant source and providing anticoagulant into the circuit.

3. The blood circuit assembly of claim 2, further comprising a pump for pumping anticoagulant from the anticoagulant source to the circuit.

4. The blood circuit assembly of claim 3, wherein the pair of pneumatic pumps, the anticoagulant connection, and the anticoagulant pump are part of a pump cassette.

5. The blood circuit assembly of claim 4, wherein the first blood line connector is connected to an inlet of the pump cassette, and an outlet of the pump cassette is connected to the first dialyzer connector.

6. The blood circuit assembly of claim 2, wherein the anticoagulant connection includes a vial holder and a spike, and the anticoagulant source is a vial of heparin.

7. The blood circuit assembly of claim 1, wherein the organizing tray includes a pair of handles arranged for gripping by a user for installing the blood circuit assembly on the front panel of the dialysis unit.

8. The blood circuit assembly of claim 7, wherein the organizing tray includes openings adjacent each of the handles for receiving retaining tabs on the dialysis unit that engage with the blood circuit assembly and retain the blood circuit assembly on the dialysis unit.

9. The blood circuit assembly of claim 8, wherein an inlet of the air trap is located above an outlet of the air trap when the blood circuit assembly is mounted to the dialysis unit.

10. The blood circuit assembly of claim 1, wherein the pneumatic pumps are pod pumps.

11. The blood circuit assembly of claim 1, 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 dialysis unit.

12. The blood circuit assembly of claim 11, wherein the blood line connectors include a frustoconical member with an internal thread for the luer-type connection, and a central tube extending from a center of the frustoconical member.

13. The blood circuit assembly of claim 12, wherein the blood line connectors include locking arms with at least one barb to engage with a complementary connector for the press-in type connection to the dialysis unit.

14. The blood circuit assembly of claim 1, wherein the organizing tray tube engagement members are arranged to be pressed toward the front panel of the dialysis unit while holding the third and fourth sections of tubing to seat said sections of tubing in the tubing occluder.

15. The blood circuit assembly of claim 14, wherein the organizing tray includes a pair of handles arranged for gripping by a user for installing the blood circuit assembly on the front panel of the dialysis unit.

16. The blood circuit assembly of claim 15, wherein the organizing tray includes openings adjacent each of the handles for receiving retaining tabs on the dialysis unit that engage with the blood circuit assembly and retain the blood circuit assembly on the dialysis unit.

17. A blood circuit assembly for a dialysis unit, comprising:

an organizing tray;

a pair of pneumatic pumps mounted to the organizing tray for circulating blood received from a patient through a circuit including a dialyzer unit and returned to the patient, each pneumatic pump comprising a rigid pod that includes an internal flexible membrane separating a pumping compartment from a control compartment, the pod including an exposed pneumatic actuation port communicating with the control compartment and configured to reversibly connect directly with a corresponding port located on a front panel of the dialysis unit;

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

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

a pair of blood line connectors, one inlet blood line connector attached to arterial tubing for receiving blood from the patient and providing blood to the pneumatic pumps and one outlet blood line connector attached to venous tubing for returning blood to the patient;

wherein the organizing tray routes the venous blood tubing attached from a connection with an outlet of the air trap, and routes the arterial blood tubing attached from a connection with the pneumatic pumps to tube engagement members of the organizing tray for alignment and engagement of said blood tubing with a tubing occluder located on the front panel of the dialysis unit.

18. The blood circuit assembly of claim 17, further comprising an anticoagulant connection for engaging with an anticoagulant source and providing anticoagulant into the circuit.

19. The blood circuit assembly of claim 18, further comprising a pump for pumping anticoagulant from the anticoagulant source to the circuit.

20. The blood circuit assembly of claim 19, wherein the pair of pneumatic pumps, the anticoagulant connection, and the anticoagulant pump are part of a pump cassette.

21. The blood circuit assembly of claim 20, wherein the inlet blood line connector is connected to an inlet of the pump cassette, and an outlet of the pump cassette is connected to one of the pair of dialyzer connectors.

22. The blood circuit assembly of claim 18, wherein the anticoagulant connection includes a vial holder and a spike, and the anticoagulant source is a vial of heparin.

23. The blood circuit assembly of claim 17, wherein an inlet of the air trap is located above an outlet of the air trap when the blood circuit assembly is mounted to the dialysis unit.

24. The blood circuit assembly of claim 17, wherein the pneumatic pumps are pod pumps.

25. The blood circuit assembly of claim 17, 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 dialysis unit.

26. The blood circuit assembly of claim 25, wherein the blood line connectors include a frustoconical member with an internal thread for the luer-type connection, and a central tube extending from a center of the frustoconical member.

27. The blood circuit assembly of claim 26, wherein the blood line connectors include locking arms with at least one barb to engage with a complementary connector for the press-in type connection to the dialysis unit.

28. The blood circuit assembly of claim 17, wherein the organizing tray tube engagement members are arranged to be pressed toward the front panel of the dialysis unit while holding the arterial and venous tubing to seat said tubing in the tubing occluder.