Dialysis system and methods

• US 9,579,440 B2
• Filed: 08/07/2015
• Issued: 02/28/2017
• Est. Priority Date: 04/29/2014
• Status: Active Grant

• Current Assignee: Outset Medical, Inc.
• Original Assignee: Outset Medical, Inc.
• Inventors: Hogard, Michael Edward, Lingam, Gopi, Hu, Dean, Maniam, Balaji M., Ritson, James, Uchida, Andy H., Stienmier, John David, McGregor, Paul David
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/821,349
• Publication Number:
  US 20150343131A1
• Time in Patent Office: 571 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. A method of returning blood in a patient tubing set of a dialysis delivery system to a patient after a dialysis treatment, comprising:

creating a pathway between a saline source and the patient tubing set at a patient arterial access site;

activating a blood pump in a forward direction, the blood pump being coupled to the patient tubing set, to draw saline from the saline source into the patient tubing set at the patient arterial access site and push blood back into the patient;

tracking a number of revolutions of the blood pump to determine a volume of saline drawn into the patient tubing set; and

de-activating the blood pump when a predetermined volume of saline is drawn into the patient tubing set, wherein the predetermined volume of saline is integrated into a fluid removal target for ultrafiltration during the dialysis treatment so a target weight of the patient is attained after returning the blood in the tubing set to the patient.

2. The method of claim 1 wherein the predetermined volume comprises 300-500 ml.

3. The method of claim 1, further comprising opening one or more pinch valves of the dialysis delivery system to create the pathway between the saline source and the patient tubing set.

4. The method of claim 1, wherein blood is pushed back into the patient through a patient venous access site.

5. A method of returning blood in a patient tubing set of a dialysis delivery system to a patient after a dialysis treatment, comprising:

creating a pathway between a saline source and the patient tubing set at a patient arterial access site;

activating a blood pump in a forward direction, the blood pump being coupled to the patient tubing set to draw saline from the saline source into the patient tubing set at the patient arterial access site and push blood back into the patient;

tracking a volume of saline drawn into the patient tubing set; and

de-activating the blood pump when a predetermined volume of saline is drawn into the patient tubing set, wherein the predetermined volume of saline is integrated into a fluid removal target for ultrafiltration during the dialysis treatment so a target weight of the patient is attained after returning the blood in the tubing set to the patient.

6. A method of returning blood in a patient tubing set of a dialysis delivery system to a patient after a dialysis treatment, comprising:

creating a pathway between a saline source and the patient tubing set at a patient arterial access site;

activating a blood pump in a forward direction, the blood pump being coupled to the patient tubing set to draw saline from the saline source into the patient tubing set at the patient arterial access site and push blood back into the patient;

tracking a volume of saline drawn into the patient tubing set; and

de-activating the blood pump when a predetermined volume of saline is drawn into the patient tubing set.