Refractometric devices especially adapted for the in vivo detection of refractive indices of cervical mucus

• US 6,149,591 A
• Filed: 12/03/1998
• Issued: 11/21/2000
• Est. Priority Date: 02/21/1997
• Status: Expired due to Fees

• Current Assignee: Duke University
• Original Assignee: Duke University
• Inventors: Katz, David F., Henderson, Marcus H.
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US09/204,163
• Time in Patent Office: 719 Days
• Field of Search: 600/407, 600/476, 600/551, 356/128-133
• US Class Current: 600/407
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/4294 vaginal secretions
• CPC Class Codes: A61B 5/4331 of the cervix A61B5/435 takes precedence

Abstract

Devices for detecting hydration of cervical mucus (which is indicative of the course of a female'"'"'s reproductive cycle) include a detector having a light source, a photoreceptor and a light guide positioned so as to guide light from the light source to the photoreceptor. The light guide includes at least one active surface to be wetted by the cervical mucus. The detector may be planar or curvelinear and may be embedded within a distal sensing head or extend upright therefrom (e.g., so as to somewhat penetrate the external cervical os during use). Most preferably, the light guide is fabricated from a fluorocarbon polymer. For use in vivo, the device will preferably include a proximal handle which allows the user to manipulate the distal sensing head into close proximity to the external cervical os. The handle may include a source of electrical power (e.g., a DC battery pack, solar cell or the like), a processor for processing the signal received from the photoreceptor indicative of the cervical mucus refractive index, and a human-readable display (e.g., an alpha-numeric display, light indicator, analog display or the like). A relatively slender (as compared to the handle) stem operatively connects the handle to the distal sensing head. The sensing head may be formed as a one-piece structure with the stem and angled relative thereto so as to assist in placement of the detector in close proximity to the external cervical os. Alternatively, the sensing head may be connected to the stem to allow for relative pivotal articulation to permit selective adjustment of the sensing head'"'"'s angular orientation relative to the stem. The stem itself may be entirely rigid, or may be flexible (e.g., longitudinally flexible, but torsionally rigid).

Claims

1. A device for the in vivo detection of refractive indices of cervical mucus at a female'"'"'s cervical os which comprises

a distal sensing head for intravaginal placement against the female'"'"'s cervical os;

and

a refractive index detector carried by said distal sensing head and having (i) a light source, (ii) a photoreceptor which receives light from said light source and outputs a signal indicative of the refractive index of the cervical mucus, and (iii) a light guide positioned so as to guide light from the light source to the photoreceptor, said light guide having at least one active surface to be wetted by the cervical mucus which consists essentially of a fluorocarbon polymer having an optical clarity of greater than about 98% and a refractive index of between about 1.335 to about 1.450.

2. The device of claim 1, wherein the light guide has an aspect ratio of between about 10:

1 to about 20;

1.

3. The device of any one of claim 1 or 2, wherein the fluorocarbon polymer is selected from copolymers comprised of tetrafluoroethylene with hexafluoropropylene comonomers, polychlorotrifluoroethylene, ethylene-tetrafluoroethylene copolymers, polyvinylidene fluoride polymers, and polyvinyl fluoride polymers.

4. The device of claim 1, having a proximal handle, and a stem connecting said handle to said sensing head.

5. The device of claim 4, wherein said stem is longitudinally rigid.

6. The device of claim 4, wherein said stem is longitudinally flexible.

7. The device of claim 6, wherein said stem is torsionally rigid.

8. The device of claim 4, wherein said handle includes an electrical power source and a visual display indicative of detected refractive index.

9. The device of claim 4, wherein said sensing head is pivotally connected to said stem to allow for angular adjustments therebetween.

10. The device of claim 1, wherein said detector includes a central support rod having a polished light-reflective surface, and wherein said light guide includes said fluorocarbon polymer supported by said support rod.

11. The device of claim 10, wherein said light guide is positioned axially between said light source and said photoreceptor.

12. The device of claim 1, wherein said detector is substantially planar.

13. The device of claim 1, wherein said detector is curvelinear.

14. A device for the in vivo detection of the refractive index of cervical mucus, said device comprising:

a proximal handle to allow vaginally external manual manipulation of the device;

an elongate stem projecting from said handle and being sufficiently slender for vaginal penetration; and

a distal sensing head connected to a distal end of said elongate stem and having a planar sensing surface which is angularly oriented with respect to said elongate stem for in vivo intravaginal placement adjacent to the external cervical os;

wherein

said sensing head includes a planar refractometer for obtaining a measurement of the cervical mucus refractive index at the external cervical os, said refractometer including;

(i) a light source for emitting light;

(ii) a photoreceptor which receives a portion of the light emitted by the light source and issues a signal indicative of the refractive index of the cervical mucus;

(iii) a light guide which guides light between said light source and said photoreceptor and which consists essentially of a fluorocarbon polymer having an optical clarity of greater than about 98% and a refractive index of between about 1.335 to about 1.450, wherein

(iv) said light guide has at least one active window which is coplanar with said planar sensing surface of said distal sensing head for contact with the cervical mucus when said sensor surface is placed against the cervical os to allow absorption of at least some of the light emitted by the light source so that said photoreceptor detects remaining unabsorbed light and issues a signal in response thereto;

(iv) a processor which receives said signal from said photoreceptor and determines the refractive index of said cervical mucus therefrom.

15. The device of claim 14, wherein the light guide has an aspect ratio of between about 10:

1 to about 20;

1.

16. The device of claim 14 or 15, wherein the fluorocarbon polymer is selected from copolymers comprised of tetrafluoroethylene with hexafluoropropylene comonomers, polychlorotrifluoroethylene, ethylene-tetrafluoroethylene copolymers, polyvinylidene fluoride polymers, and polyvinyl fluoride polymers.

17. The device of claim 14, wherein said stem is longitudinally rigid.

18. The device of claim 14, wherein said stem is longitudinally flexible.

19. The device of claim 18, wherein said stem is torsionally rigid.

20. The device of claim 14, wherein said handle includes an electrical power source, and wherein said processor includes a visual display indicative of the refractive index of the cervical mucus.

21. The device of claim 14, wherein said sensing head is pivotally connected to said stem to allow for angular adjustments therebetween.

22. The device of claim 14, wherein said light guide is positioned axially between said light source and said photoreceptor.

23. The device of claim 14, wherein said light source and said photoreceptor are oriented coaxially with said light guide.

24. The device of claim 14, wherein said light source and said photoreceptor are located below said light guide, and wherein said light guide includes a light inlet and a light outlet adjacent said light source and said photoreceptor, respectively, which are oriented at substantially right angles to said light guide.

25. The device of claim 24, wherein said light inlet has a greater widthwise dimension as compared to said photoreceptor.

26. A refractometer for determining refractive indices of liquid comprising:

a light source,

a photoreceptor which receives light from said light source and outputs a signal indicative of the refractive index of the liquid;

a light guide positioned so as to guide light from the light source to the photoreceptor,

said light guide having at least one active surface to be wetted by the liquid, wherein

said light guide consists essentially of a fluorocarbon polymer having an optical clarity of greater than about 98% and a refractive index of between about 1.335 to about 1.450.

27. The detector of claim 26, wherein the light guide has an aspect ratio of between about 10:

1 to about 20;

1.

28. The detector of any one of claim 26 or 27, wherein the fluorocarbon polymer is selected from copolymers comprised of tetrafluoroethylene with hexafluoropropylene comonomers, polychlorotrifluoroethylene, ethylene-tetrafluoroethylene copolymers, polyvinylidene fluoride polymers, and polyvinyl fluoride polymers.

29. The detector of claim 26, wherein said at least one active surface is planar.

30. The detector of claim 26, wherein said at least one active surface is curvelinear.

36. A device for the in vivo detection of cervical mucus refractive index comprising a handle, a stem extending from said handle, and a distal sensing head which includes a refractometer as in any one of claims 27-35.

31. A planar refractometer comprising:

(i) a light source;

(ii) a photoreceptor axially spaced from said light source to receive transmitted light therefrom and output a signal indicative of refractive index of a sample fluid;

(iii) a cross-sectionally U-shaped, rigid polished support channel extending between said axially spaced apart light source and photoreceptor;

(iv) a light guide positioned within said support channel, wherein

(v) upper surfaces of said support channel and said light guide are substantially coplanar with one another, and wherein

(vi) said light guide consists essentially of a fluorocarbon polymer having an optical clarity of greater than about 98% and a refractive index of between about 1.335 to about 1.450.

32. The refractometer of claim 31, wherein said support channel is defined by a bottom polished metal support rod and an opposed pair of lateral polished metal support rods.

33. The refractometer of claim 31, wherein said upper surfaces of said light source, photoreceptor and said support channel are each covered with an opaque material to thereby leave an uncovered active window of said light guide.

34. The refractometer of claim 31, wherein the light guide has an aspect ratio of between about 10:

1 to about 20;

1.

35. The refractometer of claim 31, wherein the fluorocarbon polymer is selected from copolymers comprised of tetrafluoroethylene with hexafluoropropylene comonomers, polychlorotrifluoroethylene, ethylene-tetrafluoroethylene copolymers, polyvinylidene fluoride polymers, and polyvinyl fluoride polymers.