Dialysis system and methods

• US 9,402,945 B2
• Filed: 08/07/2015
• Issued: 08/02/2016
• 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, Maniam, Balaji M., Ritson, James, Stienmier, John David, McGregor, Paul David, Hu, Dean, Uchida, Andy H.
• Primary Examiner(s): DEAK, LESLIE R
• Application Number:
  US14/821,325
• Publication Number:
  US 20150343135A1
• Time in Patent Office: 361 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 priming a tubing set and a dialyzer of a dialysis system, comprising the steps of:

operating a blood pump of the dialysis system in a reverse operating mode to flow saline in a reverse direction from a saline source, into the tubing set, into a venous drip chamber, and out of the venous drip chamber, before flowing saline into a blood-side of the dialyzer, to remove air from the tubing set and the blood-side of the dialyzer; and

operating the blood pump in a forward operating mode to flow saline in a forward direction opposite to the reverse direction, into the blood-side of the dialyzer, and out of the blood-side of the dialyzer, before flowing saline into the venous drip chamber.

2. The method of claim 1, wherein operating the blood pump in the forward operating mode flows at least a portion of the saline out of the tubing set.

3. The method of claim 2, wherein the saline is delivered to a patient.

4. The method of claim 1, further comprising:

monitoring a fluid level of the saline in a venous drip chamber of the tubing set; and

stopping operation of the blood pump in the reverse operating mode when the fluid level in the venous drip chamber stabilizes.

5. The method of claim 1, further comprising:

monitoring the tubing set for the presence of air; and

stopping operation of the blood pump in the reverse operating mode when air no longer circulates through the tubing set.

6. The method of claim 1, further comprising operating a dialysate pump to flow dialysate from a dialysate source into a dialysate-side of the dialyzer in the reverse direction to remove air from the dialysate-side of the dialyzer.

7. The method of claim 6, wherein air is removed from the dialysate-side of the dialyzer without physically manipulating an orientation of the dialyzer.

8. The method of claim 6, wherein air is removed from the dialysate-side of the dialyzer without physically adjusting an orientation of the dialyzer.

9. The method of claim 1 further comprising opening one or more valves of the dialysis system with an electronic controller to allow the saline to flow from the saline source into the tubing set.

10. The method of claim 9, further comprising periodically actuating the one or more valves to open and close the tubing set to create a pulsing effect that removes air bubbles from the dialyzer.

11. The method of claim 1 wherein the operating steps further comprise operating the blood pump with an electronic controller of the dialysis system.

12. The method of claim 1 wherein the saline flows out of the tubing set through a union joint that attaches a venous line of the tubing set to an arterial line of the tubing set.

13. The method of claim 12, wherein a predetermined volume of saline flows through the union joint before the dialysis therapy can begin.

14. The method of claim 1, wherein saline flows into the venous drip chamber and out of the venous drip chamber in both the forward and reverse operating modes through connections located at a bottom of the venous drip chamber.