Apparatus and methods for early stage peritonitis detection including self-cleaning effluent chamber

• US 8,728,023 B2
• Filed: 01/25/2008
• Issued: 05/20/2014
• Est. Priority Date: 07/27/2006
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Landherr, Frank J., Lan, Jay M.
• Primary Examiner(s): Clow, Lori A
• Application Number:
  US12/020,192
• Publication Number:
  US 20080183127A1
• Time in Patent Office: 2,307 Days
• Field of Search: None
• US Class Current: 604/29
• CPC Class Codes: A61B 5/0059 using light, e.g. diagnosis by transillumination, diascopy, fluorescence A61B5/0093, A61B5/1455, A61B5/02416 and A61B5/0261 take precedence
• CPC Class Codes: A61M 1/28 Peritoneal dialysis ; Other peritoneal treatment, e.g. oxygenation
• CPC Class Codes: A61M 1/285 Catheters therefor
• CPC Class Codes: A61M 2205/331 used as turbidity change detectors, e.g. for priming-blood or plasma-hemoglubine-interface detection

Abstract

The invention provides, inter alia, automated medical methods and apparatus that test PD effluent in a flow path (e.g., with an APD system or CAPD setup) to detect, for example, the onset of peritonitis, based on optical characteristics of the effluent resolved at cellular scales of distance. For example, according to one aspect of the invention, an APD machine includes, in an effluent flow path, apparatus for early stage peritonitis detection comprising an illumination source and a detector. The source is arranged to illuminate peritoneal effluent in a chamber that forms part of the flow path, and the detector is arranged to detect illuminant scattered by the effluent. The detector detects that reflected or scattered illuminant at a cellular scale of resolution, e.g., on a scale such that separate cellular-sized biological (or other) components in the effluent can be distinguished from one another based on scattering events detected by the detector. According to aspects of the invention, the chamber can utilize a deflector to effect turbulent flow for purposes of cleaning biological and other materials from the chamber walls.

Claims

1. An apparatus for testing peritoneal dialysis (PD) effluent in a flow path, comprising:

A) a chamber defining at least part of the flow path for the peritoneal dialysis effluent,

B) an illumination source that illuminates peritoneal effluent flowing through the chamber,

C) a detector that detects illuminant any of reflected and scattered (collectively, “

scattered”

) by the effluent flowing through the chamber,

D) the chamber inducing lamellar flow in the effluent; and

E) the chamber including a deflector disposed in the flow path, the deflector effecting a turbulent flow of fluid in the chamber that at least partially cleans inner walls thereof.

2. The apparatus of claim 1, wherein the deflector increases turbulence of effluent flowing in the chamber.

3. The apparatus of claim 1, wherein the deflector increases a Reynolds number of effluent flowing in the chamber.

4. The apparatus of claim 1, wherein the deflector prevents components of the effluent from adhering to the inner walls of the chamber and/or removes those that have already adhered to those walls.

5. The apparatus of claim 1, wherein the chamber comprises a first portion with inner walls defining a fluid flow region generally characterized as a rectangular parallelepiped.

6. The apparatus of claim 5, wherein the first portion of the chamber is coupled with a flow inlet port via a portion having inner walls with a shape generally characterized as a pyramidal frustum.

7. The apparatus of claim 6, wherein the first portion is coupled with a flow outlet port via a portion having inner walls with a shape generally characterized as a pyramidal frustum.

8. An apparatus for testing peritoneal dialysis (PD) effluent in a flow path, the apparatus comprising:

A) a chamber defining at least part of a path of flow for the peritoneal dialysis effluent and inducing lamellar flow therein,

B) an illumination source that illuminates peritoneal effluent flowing through the chamber,

C) a detector that detects illuminant any of reflected and scattered (collectively, “

scattered”

) by the effluent as it flows through the chamber,

D) the detector detects that scattered illuminant at a cellular scale of resolution such that at least selected separate cellular-sized components in the effluent can be distinguished from one another based on the illuminant that is scattered therefrom and that is (i) detected by the detector and (ii) counted; and

E) the chamber including a deflector disposed in the flow path, the deflector effecting a turbulent flow of fluid in the chamber that at least partially cleans inner walls thereof.

9. The apparatus according to claim 8, in which the detector is arranged to detect illuminant scattered from separate white blood cells (WBCs) in the effluent such that those WBCs can be distinguished from one another.

10. The apparatus according to claim 9, wherein the detector counts WBCs in the effluent based on illuminant scattered therefrom.

11. The apparatus according to claim 10, wherein the detector signals an onset of peritonitis if said counts change over time and/or vary from a baseline.

12. The apparatus according to claim 11, wherein said baseline is a baseline previously established for a patient from which the PD effluent is drained.

13. The apparatus according to claim 8, in which the detector is arranged to detect illuminant scattered from cellular-sized components of different types in the effluent such that those components can be distinguished from one another.

14. The apparatus according to claim 13, in which the detector is arranged to detect illuminant scattered from white blood cells (WBCs) in the effluent such that they can be distinguished from red blood cells (RBCs), fibrin and/or other components from which illuminant is scattered in the effluent.

15. A method for testing peritoneal dialysis (PD) effluent in a flow path, comprising:

A) inducing lamellar flow in peritoneal effluent flowing through a chamber defining at least a portion of the flow path,

B) illuminating the peritoneal effluent flowing through the chamber defining at least a portion of the flow path,

C) detecting illuminant any of reflected and scattered (collectively, “

scattered”

) by the effluent as it flows through the chamber; and

D) effecting turbulence in at least a portion of the flow of effluent in the chamber so as to at least partially clean inner walls thereof.

16. The method of claim 15, comprising utilizing a deflector that is disposed in a flow path defined by the chamber to effect such turbulence.

17. The method of claim 16, comprising utilizing the turbulence to prevent components of the effluent from adhering to the inner walls of the chamber and/or remove those that have already adhered to those walls.