Dialysis system and methods

• US 9,504,777 B2
• Filed: 08/07/2015
• Issued: 11/29/2016
• 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, Hu, Dean, Maniam, Balaji M., Ritson, James, Uchida, Andy H., Stienmier, John David, McGregor, Paul David
• Primary Examiner(s): Caputo, Lisa
• Assistant Examiner(s): ROY, PUNAM P
• Application Number:
  US14/821,307
• Publication Number:
  US 20150343132A1
• Time in Patent Office: 480 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 connecting a disposable cartridge and tubing set to a dialysis system, comprising the steps of:

positioning alignment features of the disposable cartridge and tubing set adjacent to alignment features of the dialysis system;

mounting the disposable cartridge and tubing set onto the dialysis system to;

acoustically couple a venous drip chamber of the disposable cartridge and tubing set with one or more fluid level sensors of the dialysis system, and

engage a cartridge presence detector of the dialysis system, the cartridge presence detector configured to initiate automatic loading of a blood pump portion of the cartridge and tubing set into a blood pump of the dialysis system.

2. The method of claim 1, further comprising measuring a fluid level within the venous drip chamber with the one or more fluid level sensors.

3. The method of claim 1, wherein the mounting step further comprises mating the alignment features of the disposable cartridge and tubing set with the alignment features of the dialysis system.

4. The method of claim 1, wherein the mounting step further comprises aligning the cartridge and tubing set with a blood pump of the dialysis system.

5. The method of claim 1, wherein the mounting step further comprises aligning the cartridge and tubing set with a venous pressure sensor of the dialysis system.

6. The method of claim 1, wherein the mounting step further comprises aligning the cartridge and tubing set with an arterial pressure sensor of the dialysis system.

7. The method of claim 1, wherein the mounting step further comprises aligning the cartridge and tubing set with one or more pinch clamps of the dialysis system.

8. The method of claim 1 wherein the automatic loading of the blood pump portion comprises pulling the blood pump portion of the tubing set into the blood pump with a spring wire of the blood pump.

9. A dialysis system, comprising:

a housing;

a blood pump disposed on the housing;

a first set of alignment features disposed on the housing;

one or more fluid level sensors disposed on the housing;

a cartridge presence detector disposed on the housing; and

a disposable cartridge adapted to be mounted onto the housing and to engage the cartridge presence detector, the disposable cartridge including;

a frame having a second set of alignment features configured to removably mate with the first set of alignment features on the housing;

a tubing set disposed in the frame, the tubing set comprising a blood pump portion configured to interface with the blood pump; and

a venous drip chamber disposed in the frame and connected to the tubing set, the venous drip chamber being positioned within the frame such that the venous drip chamber is coupled to the one or more fluid level sensors when the frame is mounted onto the housing;

wherein the cartridge presence detector is configured to initiate automatic loading of the blood pump portion of the tubing set into the blood pump when the frame is mounted onto the housing.

10. The dialysis system of claim 9, the blood pump comprising a spring wire, wherein the automatic loading of the blood pump portion of the tubing set comprises pulling the blood pump portion into the blood pump with the spring wire.

11. A method of connecting a disposable cartridge and tubing set to a dialysis system, comprising the steps of:

positioning alignment features of the disposable cartridge and tubing set adjacent to alignment features of the dialysis system;

mounting the disposable cartridge and tubing set onto the dialysis system to;

couple a venous drip chamber of the disposable cartridge and tubing set to one or more fluid level sensors of the dialysis system, and;

engage a cartridge presence detector of the dialysis system, the cartridge presence detector configured to initiate automatic loading of a blood pump portion of the cartridge and tubing set into a blood pump of the dialysis system.

12. The method of claim 11, further comprising measuring a fluid level within the venous drip chamber with the one or more fluid level sensors.

13. The method of claim 11, wherein the mounting step further comprises mating the alignment features of the disposable cartridge and tubing set with the alignment features of the dialysis system.

14. The method of claim 11, wherein the mounting step further comprises aligning the cartridge and tubing set with a blood pump of the dialysis system.

15. The method of claim 11, wherein the mounting step further comprises aligning the cartridge and tubing set with a venous pressure sensor of the dialysis system.

16. The method of claim 11, wherein the mounting step further comprises aligning the cartridge and tubing set with an arterial pressure sensor of the dialysis system.

17. The method of claim 11, wherein the mounting step further comprises aligning the cartridge and tubing set with one or more pinch clamps of the dialysis system.

18. The method of claim 11 wherein the automatic loading of the blood pump portion comprises pulling the blood pump portion of the tubing set into the blood pump with a spring wire of the blood pump.