Manifold diaphragms

• US 10,258,731 B2
• Filed: 02/29/2016
• Issued: 04/16/2019
• Est. Priority Date: 09/13/2007
• Status: Expired due to Fees

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Fulkerson, Barry Neil, Huang, Alec, Kelly, Brian Thomas
• Primary Examiner(s): Drodge, Joseph W
• Application Number:
  US15/055,857
• Publication Number:
  US 20170021088A1
• Time in Patent Office: 1,142 Days
• Field of Search: 2103216, 210645-647, 604 401- 611, 604 28, 604 29
• CPC Class Codes: A61M 1/152 Details related to the interface between cassette and machine
• CPC Class Codes: A61M 1/1524 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/155 with treatment-fluid pumping means or components thereof
• CPC Class Codes: A61M 1/156 Constructional details of the cassette, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/1565 Details of valves
• CPC Class Codes: A61M 1/16 with membranes
• CPC Class Codes: A61M 1/1609 after use, i.e. downstream of dialyser
• CPC Class Codes: A61M 1/1645 with mechanically linked peristaltic dialysis fluid pumps one upstream, the other one downstream of the dialyser
• CPC Class Codes: A61M 1/166 Heating for sterilisation A61M1/1686
• CPC Class Codes: A61M 1/1692 Detection of blood traces in dialysate
• CPC Class Codes: A61M 1/1696 with dialysate regeneration
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• 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 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• 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 1/3626 Gas bubble detectors
• CPC Class Codes: A61M 1/3639 Blood pressure control, pressure transducers specially adapted therefor
• CPC Class Codes: A61M 1/3641 Pressure isolators
• CPC Class Codes: A61M 1/3646 : Expelling the residual body fluid after use, e.g. back to the body
• CPC Class Codes: A61M 1/3656 : Monitoring patency or flow at connection sites; Detecting disconnections
• CPC Class Codes: A61M 2205/126 : with incorporated membrane filters
• CPC Class Codes: A61M 2205/13 : with means for the detection of operative contact with patient, e.g. lip sensor
• 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 2205/15 : Detection of leaks
• CPC Class Codes: A61M 2205/18 : with alarm
• CPC Class Codes: A61M 2205/3317 : Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3324 : PH measuring means
• CPC Class Codes: A61M 2205/3331 : Pressure; Flow
• CPC Class Codes: A61M 2205/3334 : Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/3368 : Temperature
• CPC Class Codes: A61M 2205/3375 : Acoustical, e.g. ultrasonic, measuring means
• CPC Class Codes: A61M 2205/3393 : by weighing the reservoir
• CPC Class Codes: A61M 2205/3553 : remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 : using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 : User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 : Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: B01D 2313/10 : Specific supply elements
• CPC Class Codes: B01D 2313/105 : Supply manifolds
• CPC Class Codes: B01D 2313/12 : Specific discharge elements
• CPC Class Codes: B01D 2313/125 : Discharge manifolds
• CPC Class Codes: B01D 2313/243 : Pumps
• CPC Class Codes: B01D 61/18 : Apparatus therefor
• CPC Class Codes: B01D 61/30 : Accessories; Auxiliary operation
• CPC Class Codes: B01D 61/32 : Controlling or regulating

Abstract

The specification discloses a portable dialysis machine having a detachable controller unit and base unit. The controller unit includes a door having an interior face, a housing with a panel, where the housing and panel define a recessed region configured to receive the interior face of the door, and a manifold receiver fixedly attached to the panel. The manifold includes diaphragms adapted to minimize the dead space between the dialysis machine pins and improve responsivity. The base unit has a planar surface for receiving a container of fluid, a scale integrated with the planar surface and a heater in thermal communication with the container. Embodiments of the disclosed portable dialysis system have improved structural and functional features, including improved modularity, ease of use, and safety features.

Claims

1. A dialysis system comprising:

a dialysis machine having a controller, sensor component, a reservoir and a dialyzer;

a disposable monolithic manifold in fluid communication with the reservoir and dialyzer, wherein the disposable monolithic manifold has a diaphragm integrated therein and is adapted for installation in the dialysis machine, wherein the diaphragm is adapted to be compressed by the sensor component located within the dialysis machine and external to the disposable manifold, and wherein the diaphragm comprises;

a convex exterior surface protruding outward from the manifold and fixedly attached to the manifold at a first end and at a second end, wherein a distance between the first end and second end defines a length and height of the diaphragm, wherein the diaphragm at the first end and second end has the same height as the manifold, wherein the height of the convex exterior surface increases from the first end to a first height relative to the manifold, and wherein the height of the convex exterior surface decreases from the first height to the second end.

2. The dialysis system of claim 1, wherein the first height of the diaphragm is between 0.03 and 0.04 inches relative to the manifold.

3. The dialysis system of claim 1, wherein the diaphragm has a thickness along the length from the first end to the second end and wherein the thickness is substantially constant along the length.

4. The dialysis system of claim 1, wherein the thickness of the diaphragm is between 0.03 and 0.04 inches.

5. The dialysis system of claim 1, wherein a total length of the diaphragm is between 0.625 and 0.675 inches.

6. A dialysis system comprising:

a dialysis machine having a controller, a sensor component, a reservoir and a dialyzer;

a disposable monolithic manifold having a diaphragm integrated therein and adapted for installation in the dialysis machine, wherein the diaphragm has a substantially planar periphery and a raised convex protrusion, wherein the convex protrusion is centrally located within the substantially planar periphery, wherein the periphery has a height equal to a height of an external surface of the manifold, wherein the convex protrusion has a height greater than the height of the planar periphery, wherein the convex protrusion represents a surface area ranging from 10% to 40% of a total surface area of the diaphragm and wherein the convex protrusion is adapted to be compressed by the sensor components located within the dialysis machine and external to the manifold.

7. The dialysis system of claim 6 wherein the diaphragm has a length ranging from 0.625 inches to 0.675 inches.

8. The dialysis system of claim 6 wherein the convex protrusion has a height ranging from 0.03 inches to 0.04 inches.

9. The dialysis system of claim 6 wherein the raised convex protrusion represents a surface area ranging from 19% to 23% of a total surface area of the diaphragm.

10. A dialysis system comprising:

a dialysis machine having a controller, a sensor component, a reservoir and a dialyzer;

a disposable monolithic manifold having a diaphragm integrated therein and adapted for installation in the dialysis machine, wherein the diaphragm comprises a convex periphery having a first height which is greater than a height of an external surface of the manifold and a raised convex protrusion located in a center of the diaphragm adapted to contact, and be compressed by, the sensor component, wherein the convex protrusion is located within the convex periphery, wherein the convex protrusion has a second height greater than the first height.

11. The dialysis system of claim 10 wherein the diaphragm has a length ranging from 0.625 inches to 0.675 inches.

12. The dialysis system of claim 10 wherein the convex protrusion has a height ranging from 0.03 inches to 0.04 inches.

13. The dialysis system of claim 10 wherein the convex protrusion has a height ranging from 0.1 inches to 0.02 inches above a plurality inflection points on each side of the periphery, the inflection points defining an end of the periphery and a beginning of the protrusion.

14. The dialysis system of claim 10 wherein the periphery has a height of 0.02 inches with respect to the manifold external surface.

15. The dialysis system of claim 10 wherein a thickness of the diaphragm is constant throughout a surface area of the diaphragm, wherein the thickness ranges from 0.03 inches to 0.04 inches.