DIALYSIS SYSTEM AND METHODS

• US 20150314055A1
• Filed: 04/29/2015
• Published: 11/05/2015
• Est. Priority Date: 04/29/2014
• Status: Abandoned Application

• Current Assignee: Outset Medical, Inc.
• Original Assignee: Andy H. Uchida, Dean Hu, Gopi Lingam
• Inventors: HU, Dean, HOGARD, Michael Edward, LINGAM, Gopi, MANIAM, Balaji M., RITSON, James, UCHIDA, Andy H., STIENMIER, John David, MCGREGOR, Paul David
• Application Number:
  US14/699,875
• Publication Number:
  US 20150314055A1
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 1/1656 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 1/1672 using membrane filters, e.g. for sterilising the dialysate
• CPC Class Codes: A61M 1/1686 by heat
• CPC Class Codes: A61M 1/36222 Details related to the interface between cassette and machine
• 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 1/362262 Details of incorporated reservoirs
• 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 1/3643 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 2205/121 interface between cassette and base
• CPC Class Codes: A61M 2205/123 with incorporated reservoirs
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3365 : Rotational speed
• CPC Class Codes: A61M 2205/3673 : thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: B01D 19/0063 : Regulation, control including valves and floats for construction and details of valves F16K
• CPC Class Codes: Y10T 137/0424 : Liquid cleaning or flushing
• CPC Class Codes: Y10T 29/49782 : of a slide fastener
• CPC Class Codes: Y10T 29/49897 : Registering mating opposed tool parts [e.g., registering a punch and a cooperating die]

Abstract

Dialysis systems and methods are described which can include a number of features. The dialysis systems described can be to provide dialysis therapy to a patient in the comfort of their own home. The dialysis system can be configured to prepare purified water from a tap water source in real-time that is used for creating a dialysate solution. The dialysis systems described also include features that make it easy for a patient to self-administer therapy. For example, the dialysis systems include disposable cartridge and patient tubing sets that are easily installed on the dialysis system and automatically align the tubing set, sensors, venous drip chamber, and other features with the corresponding components on the dialysis system. Methods of use are also provided, including automated priming sequences, blood return sequences, and dynamic balancing methods for controlling a rate of fluid transfer during different types of dialysis, including hemodialysis, ultrafiltration, and hemodiafiltration.

Claims

1-39. -39. (canceled)

40. A disposable cartridge adapted to be inserted into a dialysis system for use in dialysis therapy, comprising:

an organizer having a plurality of aligning holes configured to mate with alignment pegs on the dialysis delivery system;

a tubing set disposed in the organizer, the tubing set comprising;

an arterial line portion configured to draw blood from a patient;

a venous line portion configured to return blood to the patient;

a blood pump portion configured to interface with a blood pump of the dialysis delivery system;

a first dialyzer portion configured to carry blood to a dialyzer of the dialysis delivery system;

a second dialyzer portion configured to return blood from the dialyzer;

first and second saline lines configured to couple a saline source to the tubing set;

a venous drip chamber disposed in the organizer and configured to remove air from blood entering the venous drip chamber, the venous drip chamber comprising;

first and second ports disposed on a lower portion of the venous drip chamber, the first port being coupled to the venous line portion of the tubing set, the second port being coupled to the arterial line portion of the tubing set.

41. The disposable cartridge of claim 40, further comprising a heparin line configured to couple a heparin source to the tubing set.

42. The disposable cartridge of claim 41, wherein the heparin line is coupled to a third port disposed on an upper portion of the venous drip chamber.

43. The disposable cartridge of claim 42, wherein the heparin line is coupled to the venous drip chamber at a non-pulsatile location to prevent back streaming of blood into the heparin line during therapy.

44. The disposable cartridge of claim 43, wherein the non-pulsatile location comprises an air gap in the venous drip chamber.

45. The disposable cartridge of claim 40, wherein the first saline line is attached to the tubing set at a proximal end of the blood pump portion of the tubing set.

46. The disposable cartridge of claim 40, wherein the second saline line is attached to the tubing set near a proximal end of the arterial line portion of the tubing set.

47. The disposable cartridge of claim 40, further comprising of an arterial pressure pod disposed along the arterial line portion of the tubing set and configured to mate with an arterial pressure sensor of the dialysis delivery system.

48. The disposable cartridge of claim 40, further comprising of a venous transducer connection coupled to the venous drip chamber and configured to mate with a venous pressure sensor of the dialysis delivery system.

49. A dialysis system, comprising:

a housing;

a water purification system disposed in the housing and configured to prepare water for use in dialysis therapy in real-time using an available water source;

a dialysis delivery system disposed in the housing configured to prepare dialysate for dialysis therapy;

a dialyzer disposed on or in the housing;

a front panel disposed on the housing;

the front panel comprising;

a plurality of alignment features;

a venous level sensor;

a blood pump;

a plurality of pinch valves;

an organizer configured to be mounted to the front panel, the organizer including a plurality of mounting features configured to mate with the plurality of alignment features, the organizer comprising;

a tubing set disposed in the organizer, the tubing set comprising;

an arterial line portion configured to draw blood from a patient;

a venous line portion configured to return blood to the patient;

a blood pump portion configured to interface with the blood pump;

a first dialyzer portion configured to carry blood to the dialyzer;

a second dialyzer portion configured to return blood from the dialyzer;

first and second saline lines configured to couple a saline source to the tubing set;

a venous drip chamber disposed in the organizer and configured to remove air from blood entering the venous drip chamber, the venous drip chamber comprising;

first and second ports disposed on a lower portion of the venous drip chamber, the first port being coupled to the venous line portion of the tubing set, the second port being coupled to the arterial line portion of the tubing set;

wherein mounting the organizer to the front panel automatically couples the blood pump portion of the tubing set to the blood pump and the venous drip chamber to the venous level sensor.