Apparatus and methods for early stage peritonitis detection and for in vivo testing of bodily fluid

• US 8,777,891 B2
• Filed: 01/25/2008
• Issued: 07/15/2014
• Est. Priority Date: 07/27/2006
• 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: Landherr, Frank J., Lan, Jay M.
• Primary Examiner(s): Clow, Lori A
• Application Number:
  US12/020,171
• Publication Number:
  US 20080183126A1
• Time in Patent Office: 2,363 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. Other aspects of the invention provide automated medical testing methods and apparatus that detect the onset of peritonitis and other bodily conditions by testing fluids in the body in vivo, e.g., the patient'"'"'s peritoneum. Such apparatus and methods utilize a first fiber optic bundle to carry illuminant from a source of the type described above into a bodily organ or cavity, and a second fiber optic bundle to carry illuminant scattered by fluid in that organ or cavity to a detector as described above.

Claims

1. An apparatus for in vivo testing of fluids in a patient'"'"'s body, comprising:

A) an illuminant source and illuminant detector, both disposed external to a patient,

B) a first fiber optic bundle that carries illuminant from the source into the patient'"'"'s body,

C) a second fiber optic bundle that carries illuminant scattered by fluid in the patient'"'"'s body to the detector,

D) wherein distal ends of the first and second fiber optic bundles are configured so that the second fiber optic bundle captures and transmits to the detector reflected and/or scattered (collectively, “

scattered”

) illuminant at a cellular scale of resolution such that selected cellular-sized biological components are distinguished and counted, and

E) a lens that resolves the scattered illuminant at a cellular scale of distances such that separate cellular-sized components of a same type are distinguished from one another and so counted, where those components are any of white blood cells, red blood cells, fibrin, bubbles, and other cellular-sized components of the fluid and wherein the number of counts are analyzed over time and/or from a baseline.

2. The apparatus of claim 1, wherein the first and second fiber optic bundles are configured so that the second fiber optic bundle captures and transmits to the detector the scattered illuminant on a scale such that separate cellular-sized biological or other components in the patient'"'"'s body are distinguished from one another.

3. The apparatus of claim 1, wherein any of the first and second fiber optic bundles are routed to the patient'"'"'s body via a catheter.

4. The apparatus of claim 1, comprising any of a lens and a columnator disposed at a proximal end of the first fiber optic bundle to shape illuminant generated by the source for transfer to the first fiber optic bundle.

5. The apparatus of claim 1, comprising any of a lens and a columnator disposed at a distal end of the first fiber optic bundle to shape the illuminant transmitted thereby into the patient'"'"'s body.

6. The apparatus of claim 1, wherein illuminant emanating from the distal end of the first fiber optic bundle evokes scattering from biological and other components in the patient'"'"'s body.

7. The apparatus of claim 6, wherein the distal end of the second optic fiber bundle captures and transmits to the detector such scattered illuminant.

8. The apparatus of claim 7, wherein the distal end of the second optic fiber bundle captures illuminant side-scattered by biological and other components in the patient'"'"'s body.

9. The apparatus of claim 7, wherein the distal end of the second optic fiber bundle captures illuminant any of back-scattered, forward-scattered, and/or side-scattered by biological and other components in the patient'"'"'s body.

10. An apparatus for in vivo testing of fluid in a bodily organ or cavity of a patient, comprising:

A) a catheter,

B) an illuminant source and illuminant detector, both disposed external to a patient,

C) a first fiber optic bundle that carries illuminant from the source into the bodily organ or cavity,

D) a second fiber optic bundle that carries to the detector illuminant scattered by fluid, including biological or other components therein, contained in the bodily organ or cavity,

E) the first and second fiber optic bundles being disposed at least partially in the catheter,

F) a tip disposed at a distal end of the catheter that secures distal ends of the first and second fiber optic bundles such that the second fiber optic bundle captures and transmits to the detector illuminant reflected and/or scattered (collectively, “

scattered”

) in the bodily organ or cavity at a cellular scale of resolution such that selected cellular-sized biological components are distinguished and counted, and

G) a lens that resolves the scattered illuminant at a cellular scale of distances such that separate cellular-sized components of a same type are distinguished from one another and so counted, where those components are any of white blood cells, red blood cells, fibrin, bubbles, and other cellular-sized components of the fluid and wherein the number of counts are analyzed over time and/or from a baseline.

11. The apparatus of claim 10, wherein the first and second fiber optic bundles are configured so that the second fiber optic bundle detects and transmits to the detector scattered illuminant on a scale such that separate cellular-sized biological or other components in the peritoneum are distinguished from one another.

12. The apparatus of claim 10, wherein the source is a laser diode or other source of coherent illuminant.

13. The apparatus of claim 12, comprising any of:

A) a lens and a columnator disposed at a proximal end of the first fiber optic bundle to shape illuminant generated by the source for transfer to the first fiber optic bundle, and

B) any of a lens and a columnator disposed at a distal end of the first fiber optic bundle to shape the illuminant transmitted thereby into the patient'"'"'s body.

14. The apparatus of claim 10, comprising an interface unit that is disposed remotely from the detector and that displays information received therefrom.

15. The apparatus of claim 14, wherein the remote interface is coupled with the detector by way of a wireless link.

16. The apparatus of claim 15, wherein the wireless link is any of a Bluetooth®

connection and infrared link.

17. The apparatus of claim 14, wherein the remote interface is coupled with the detector by way of any of a wired link, a wireless link or a combination thereof.

18. The apparatus of claim 14, wherein the interface unit controls any of the detector and the source.

19. The apparatus of claim 14, wherein the remote interface is sized and configured to be slipped onto/into a pocket and/or worn by the patient, a health care provider, or other person.

20. An apparatus for in vivo testing of peritoneal fluid, comprising:

A) at least one of a catheter and a transfer set,

B) an illuminant source and illuminant detector, both disposed external to a patient,

C) a first fiber optic bundle that carries illuminant from the source into the patient'"'"'s peritoneum,

D) a second fiber optic bundle that carries to the detector illuminant scattered by fluid, including biological or other components therein, contained in the peritoneum,

E) the first and second fiber optic bundles being disposed at least partially in the catheter,

F) distal ends of the first and second fiber optic bundles being disposed in the peritoneum such that the second fiber optic bundle captures and transmits to the detector illuminant reflected and/or scattered (collectively, “

scattered”

) in the peritoneum, and

G) a lens that resolves the scattered illuminant at a cellular scale of distances such that separate cellular-sized components of a same type are distinguished from one another and counted, where those components are any of white blood cells, red blood cells, fibrin, bubbles, and other cellular-sized components of the fluid and wherein the number of counts are analyzed over time and/or from a baseline.

21. The apparatus according to claim 20, in which the detector determines a refraction index of fluid in the peritoneum as a function of illuminant scattered by fluid therein.

22. The apparatus according to claim 20, in which the detector detects illuminant scattered from separate white blood cells (WBCs) in the peritoneum such that those WBCs are distinguished from one another.

23. The apparatus according to claim 22, wherein the detector counts WBCs in the peritoneum based on the illuminant scattered therefrom.

24. The apparatus according to claim 23, wherein the detector signals an onset of peritonitis if said counts change over time and/or vary from said baseline.

25. The apparatus according to claim 24, wherein said baseline is a baseline previously established for the patient.

26. The apparatus according to claim 20, in which the detector detects illuminant scattered from cellular-sized components of different types in the peritoneum such that those components are distinguished from one another.

27. The apparatus according to claim 26, in which the detector detects illuminant scattered from white blood cells (WBCs) in the peritoneum such that they are distinguished from red blood cells (RBCs), fibrin and/or other components from which the illuminant is scattered in the peritoneum.

28. A method for in vivo testing of peritoneal fluid, comprising:

A) illuminating fluid in a patient'"'"'s peritoneum,

B) resolving with a lens detecting illuminant any of reflected and scattered (collectively, “

scattered”

) by the fluid at a cellular scale of resolution such that at least selected separate cellular-sized components of a same type in the fluid are distinguished from one another,

C) detecting from the resolved scattered illuminant cellular-sized components of a same type and counting them, where those components are any of white blood cells, red blood cells, fibrin, bubbles, and other cellular-sized components of the fluid and wherein the number of counts are analyzed over time and/or from a baseline.

29. The method according to claim 28, comprising detecting illuminant scattered from separate white blood cells (WBCs) in the peritoneum such that those WBCs are distinguished from one another.

30. The method according to claim 29, comprising counting WBCs in the peritoneum based on the illuminant scattered therefrom.

31. The method according to claim 30, comprising signaling an onset of peritonitis if said counts change over time and/or vary from said baseline.

32. The method according to claim 28, comprising detecting illuminant scattered from cellular-sized components of different types in the peritoneum such that those components are distinguished from one another.

33. The method according to claim 32, comprising detecting illuminant scattered from white blood cells (WBCs) in the effluent such that they are distinguished from red blood cells (RBCs), fibrin and/or other components from which the illuminant is scattered in the peritoneum.

34. A method for testing fluid in any body cavity or organ, comprising:

A) illuminating fluid in the body cavity or organ,

B) resolving with a lens illuminant any of reflected and scattered (collectively, “

scattered”

) by the fluid at a cellular scale of resolution such that at least selected separate cellular-sized components of a same type in the fluid are distinguished from one another,

C) detecting from the resolved scattered illuminant cellular-sized components of a same type and counting them, where those components are any of white blood cells, red blood cells, fibrin, bubbles, and other cellular-sized components of the fluid and wherein the number of counts are analyzed over time and/or from a baseline.