WO2000032100A1 - Refractometric device for the in vivo detection of fertile periods of ovulating females - Google Patents
Refractometric device for the in vivo detection of fertile periods of ovulating females Download PDFInfo
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- WO2000032100A1 WO2000032100A1 PCT/US1999/028482 US9928482W WO0032100A1 WO 2000032100 A1 WO2000032100 A1 WO 2000032100A1 US 9928482 W US9928482 W US 9928482W WO 0032100 A1 WO0032100 A1 WO 0032100A1
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- WIPO (PCT)
- Prior art keywords
- detector
- light
- light guide
- photoreceptor
- fluorocarbon polymer
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
- A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
- A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14507—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue specially adapted for measuring characteristics of body fluids other than blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
- A61B5/4261—Evaluating exocrine secretion production
- A61B5/4294—Evaluating exocrine secretion production vaginal secretions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
- A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
- A61B5/4318—Evaluation of the lower reproductive system
- A61B5/4331—Evaluation of the lower reproductive system of the cervix
Definitions
- the present invention relates generally to refractometric devices. More particularly, the present invention relates to the field of refractometric devices which allow in vivo ovulation detection in female mammals.
- Detecting with reasonable precision the fertile period of the female reproductive cycle would have significant benefits from a human "family planning" aspect as well as with animal husbandry. For example, by detecting the fertile period, a woman would be able to determine when intercourse would likely lead to conception. Such information could therefore be used by the woman to either refrain from or engage in intercourse if contraception or conception is desired, respectively. Similarly, livestock breeders would be able to maximize successful inseminations with knowledge of the ovulation cycle of the particular breeding animal.
- a vaginal mucus sample must first be positioned between a pair of plates at a specific pressure and temperature in order to provide a mucus stratum of predetermined thickness.
- a photometer measures the optical transmissivity and/or diffusivity in order to determine the phase of the menstrual cycle.
- the present invention relates to a device that detects in vivo physiological changes in a female's cervical mucus. These changes correlate with the timing of ovulation and thus provide a marker for the fertile period of the menstrual cycle.
- the fertile period is the time interval during which unprotected intercourse can lead to pregnancy. The period extends several days before the day of ovulation and ends immediately after that day. More particularly, the device of the present invention measures the water content, or hydration of cervical mucus, which has been shown to increase several days before ovulation.
- mucus hydration correlates with the pre-ovulation rise in luteinizing hormone (LH) which only precedes ovulation by 24-36 hours, and thus occurs after the onset of the fertile period.
- Other hormone changes e.g., those of estradiol or progesterone, are less consistent within and among women than the increase in mucus hydration and thus are less robust markers of the fertile period.
- the device of this invention therefore measures in vivo the mucus hydration by its direct correlate, the index of refraction of the mucus. As a result, problems associated with in vitro measurement of mucus hydration (e.g., possible mucus dehydration when a sample is removed from the body) are eliminated.
- the device of this invention generally includes a refractive index 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).
- the light guide is fabricated from a fluorocarbon polymer.
- the device of this invention will 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 photodetector 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.
- 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.
- FIGURE 1 is a perspective view of one embodiment of a refractometric device in accordance with the present invention
- FIGURE 2 is an enlarged top plan view of the distal (detector) end of the device shown in FIGURE 1 ;
- FIGURE 3 is a longitudinal cross-sectional elevational view through the detector employed in the device of this invention as taken along lines 3-3 in FIGURE 2;
- FIGURE 4 is a latitudinal cross-sectional elevational view through the detector employed in the device of this invention as taken along lines 4-4 in FIGURE 2;
- FIGURE 5 is an enlarged perspective view showing a modified distal (sensing) end in accordance with another embodiment of this invention.
- FIGURE 6 is an enlarged perspective view showing a differently configured detector that may be employed in the devices of this invention.
- FIGURE 7 is a plan view of the detector depicted in FIGURE 6;
- FIGURE 8 is an end elevational view of the detector depicted in FIGURE 7 as taken along line 8-8 therein;
- FIGURE 9 is a latitudinal cross-sectional view of the detector depicted in FIGURE 7 as taken along line 9-9 therein;
- FIGURE 10 is a side elevational view of the detector depicted in FIGURE 7 as taken along line 10-10 therein;
- FIGURE 11 is a longitudinal cross-sectional view of the detector depicted in FIGURE 7 as taken along line 11-11 therein;
- FIGURE 12 is an enlarged top plan view showing a modified distal (sensing) end in accordance with another embodiment of this invention.
- FIGURE 13 is a bottom plan view of the embodiment depicted in FIGURE 12;
- FIGURE 14 is a cross-sectional elevational view through the detector section of the embodiment depicted in FIGURE 12 as taken along line 14-14 therein;
- FIGURE 15 is a top plan view of another embodiment of a refractometric device in accordance with the present invention.
- FIGURE 16 is side elevational view of the device depicted in FIGURE 15;
- FIGURE 17 is an enlarged end elevational view of the device depicted in FIGURE 15 as taken along line 17-17 in FIGURE 16;
- FIGURE 18 is an enlarged perspective view of the distal (detector) end of the device shown in FIGURE 15;
- F1GURE 19 is a side elevational view of the detector depicted in FIGURE 18;
- FIGURES 20 and 21 are each cross-sectional elevational views of the detector depicted in FIGURE 18 as taken along lines 20-20 and 21- 21 , respectively, therein;
- FIGURE 22 is a cross-sectional plan view of the detector depicted in FIGURE 18 as taken along line 22-22 in FIGURE 21 ;
- FIGURE 23 is a graph of the voltage across a photodiode versus concentration and refractive index of sucrose solutions obtained from the data of the Example below.
- FIGURE 1 A particularly preferred embodiment of a device 10 in accordance with the present invention is depicted in FIGURE 1. As shown, the device
- proximal handle 12 to allow the device 10 to be gripped and manually manipulated during use
- a relatively slender (as compared to the handle) stem 14 extending distally from the handle 12 along a common axis.
- the stem 14 terminates in a distal sensing head
- the stem 14 and distal sensing head 16 are formed as a one piece structure from a biomedically compatible plastics material.
- the distal sensing head 16 carries a refractive index detector 18 for placement against the woman's external cervical os during use. As will be explained in greater detail below, the detector 18 measures the refractive index of the woman's cervical mucus which, in turn, is indicative of ovulation.
- the detector 18 is connected electrically to an electrical power source 12-1 (e.g., a battery pack, photocells or the like) and processor 12-2 contained within the handle 12 via wires (not shown) embedded in the stem 14.
- a button 12-3 at the proximal end of the handle 12 activates the detector 18 and causes a signal indicative of the refractive index to be supplied to the processor 12-2.
- the processor 12-2 may then display the signal in a human-readable format via a visual display panel 12-4.
- the display panel 12-4 may numerically display the detected refractive index of the cervical mucus and/or may process the signal to display a light signal indicative of a fertile period should the refractive index deviate from a predetermined value.
- FIGURES 2-4 show in greater detail the refractive index detector 18 that is employed in the device 10 described above with reference to FIGURE 1.
- the detector 18 includes a light source 18-1 (e.g., a conventional LED) and a photodetector 18-2 (e.g., a conventional photodiode) axially spaced from the light source 18-1.
- An elongated channel having a U-shaped cross-section is formed axially between the light source 18-1 and photodetector 18-2 by means of stainless steel support rods 18-3, 18-4 and 18-5.
- the channel is filled with a fluorocarbon polymer (e.g., Teflon ® FEP fluorocarbon polymer commercially available from DuPont) which serves as the light guide 18-6 for the detector 18.
- a fluorocarbon polymer e.g., Teflon ® FEP fluorocarbon polymer commercially available from DuPont
- the surface 18-7 of the support rod 18-4 in contact with the fluorocarbon light guide 18-6 is polished so as to provide a light- reflective surface interface therebetween.
- the upper surfaces of the light source, 18-1 , photodetector 18-2, support rods 18-3 and 18-5 and the light guide 18-6 are each substantially co-planar with the upper surface of the sensing head 16 so as to present a smooth external surface to the user.
- the upper surfaces of the light source, 18-1 , photodetector 18-2 and support rods 18-3 and 18-5 may be covered by an opaque film coating (e.g., black paint) so as to mask all available light paths except for that provided by the light guide 18-6.
- an opaque film coating e.g., black paint
- any fluorocarbon polymer having a refractive index (ASTM D-542) of between about 1.335 to about 1.450, and more preferably between about 1.341 to about 1.347 may be used in the practice of this invention.
- the fluorocarbon polymer employed in this invention will also exhibit, or may be processed to exhibit, an optical clarity of about 98% or greater, and more preferably about 99% or greater.
- optical clarity is 100% minus the percent haze value as determined by ASTM D 1003-61 (reapproved 1988, incorporated fully by reference herein).
- fluorocarbon polymer as used herein and in the accompanying claims is meant to refer to any polymer, copolymer, terpolymer and the like having at least one (preferably more than one) fluorocarbon moiety in a repeat unit of its molecular chain.
- preferred fluorocarbon polymers include copolymers comprised of tetrafluoroethylene with hexafluoropropylene comonomers, polychlorotrifluoroethylene, ethylene-tetrafluoroethylene copolymers, polyvi ⁇ ylidene fluoride polymers, and polyvinyl fluoride polymers.
- Particularly preferred according to this invention are copolymers comprised of tetrafluoroethylene with hexafluoropropylene comonomers commercially available from DuPont under the registered trademark Teflon ® FEP fluorocarbon polymers.
- the preferred fluorocarbon polymers will exhibit a refractive index (ASTM D-542) of between about 1.341 to about 1.347.
- the optical clarity of the preferred fluorocarbon polymers may be increased by heating the polymer to greater than its glass transition temperature (T g ) followed by rapid quenching of the heat-treated polymer.
- T g glass transition temperature
- the resulting heat-treated and quenched fluorocarbon polymer will most preferably exhibit an optical clarity of about 98% or greater, and more preferably about 99% or greater.
- FIGURE 5 depicts a modification of the device 10 shown above which allows hinged articulation to occur between the sensing head 16 and the stem 14.
- the distal end of the stem 14 includes a U-shaped yoke comprised of a pair of parallel, laterally spaced fingers 14-1 , 14-2.
- the sensing head 16 includes a proximally projecting boss 16-8 which is sandwiched between the fingers 14-1 and 14-2 so as to be in interference fit therewith.
- Mechanical stability may be increased by providing a hinge pin (not shown) with its ends embedded in the fingers 14-1 and 14-2, and extending through the boss 16-8 to allow the sensing head 16 to pivot therearound (arrow A in FIGURE 5).
- the head 16 may be positioned between the yoke fingers 14-1 , 14-2, in which case the proximally projecting boss 16-8 may be omitted.
- detents may be provided as desired to frictionally lock the sensing head in one of several angular orientations relative to the stem 14. In such a manner, the user may angularly adjust the orientation between the sensing head 16 and the stem 14 to ensure proper presentation of the detector 18 to the external cervical os.
- FIGURES 6-11 depict another embodiment of a refractive index detector 20 that may be employed instead of the detector 18 in the device 10 described above.
- the detector 20 includes a stainless steel support plate 22 which may be embedded into the sensing head 16 of the device 10.
- the detector 20 protrudes upwardly from the surface of the sensing head 16 and thus provides a pair of lateral active surfaces or "windows" in the light guide for detecting the refractive index of the cervical mucus.
- the detector 20 includes generally a base section 24 having a generally triangular cross-section with a convexly protruding upper section 26 extending from its apex.
- the base section 24 includes a central stainless steel support member 28 having a triangularly shaped cross-section embedded within the fluorocarbon light guide 30.
- a U-shaped reflector 32 is positioned over the apex of the support member 28 so as to guide light therearound.
- the surfaces 28-1 and 28-2 are highly polished reflective surfaces corresponding to the active window surfaces 30-1 and 30-2 of the light guide 30.
- the structures of the detector 20 shown in FIGURES 6-11 permit the light source LS (e.g., a light emitting diode) and photoreceptor PR (e.g., a photodiode) to be positioned below the base plate 22.
- the light source LS and photoreceptor PR can conveniently be encased completely by the biomedically compatible plastics material forming the sensing head 16.
- the convexly protruding upper section 26 provides a convenient tactile positioning aid to the user in locating the detector within the external cervical os. In such a manner, therefore, the active surfaces 30-1 and 30-2 of the light guide 30 may be brought into direct contact with the cervical mucus so that accurate refractive index readings may be obtained.
- FIG. 12-14 Another refractive index detector 40 that may be employed in the device 10 is depicted in accompanying FIGURES 12-14.
- the detector 40 is generally planar and comprised of a primary support plate 42 which defines a central window for receiving a secondary support plate 44, each of which is preferably formed of stainless steel.
- the secondary support plate 44 is configured so as to be relatively thinner in cross-sectional thickness as compared to the primary support plate 42.
- the reflective surface 44a of the secondary support plate 42 is recessed from the upper surface of the primary support plate 42 so as to provide space for the fluorocarbon light guide 46.
- the inlet light conduit 46-1 is generally triangular in cross-section by virtue of the opposed beveled edges 42-1 and 44-1 of the primary and secondary support plates 42, 44, respectively.
- the longitudinally opposed edges 42-3 and 42- 4 of the primary support plate 42 are beveled so as to help reflect light into and out of the planar light guide 46.
- the light guides associated with the detectors 18, 20 and 46 are each planar and have a substantially uniform thickness dimension along their lengths and widths.
- the light guides may be convexly curveli ⁇ ear. Such curvelinear light guides, however, will still have a substantially uniform thickness dimension along their lengths and widths similar to the planar light guides already discussed above.
- the light guides of this invention will have an aspect ratio - that is t/l where t is the thickness of the light guide and I is the wetted length of the light guide -- of between about 1 :10 to about 1 :20.
- the aspect ratios of the detectors of this invention thus translate into wetted lengths of between about 0.050 to about 0.300 inch, and more preferably between about 0.100 to about 0.200 inch.
- each of the active surfaces for paired active surface detectors according to this invention (e.g., the embodiment depicted in FIGURE 6), will be one-half of the total wetted length dimension noted above.
- FIGURES 15-17 Another embodiment of a device 50 according to the present invention is depicted in accompanying ⁇ FIGURES 15-17.
- the device 50 includes a proximal handle 52 and a distal sensing head 54.
- the handle 52 includes a battery pack 52-1 , a processor 52-2, visual display 52-3 and operational button 52-4 which serve similar functions to those similar components described above with reference to FIGURE 1.
- the sensing head 54 carries a detector 56 (to be described in greater detail below). However, unlike the device 10 discussed previously (which employs an entirely rigid stem 14), the sensing head 54 is connected to the handle 52 by means of a longitudinally flexible, but torsionally rigid, stem 58.
- the longitudinal flexibility of the stem 58 thus allows the device 50 to be configured so as to accommodate individual anatomical differences in the orientation of the external cervical os and vagina.
- the torsional rigidity of the stem 58 permits the user to rotate the sensing head 54 to permit tactile placement of the detector within the external cervical os so that precise refractive index readings may be obtained.
- a distal portion of the stem 58 is rotationally supported by a lateral support member 60 (see FIGURE 17) which may be attached to a user's finger F by means of an adjustable elastic (or similar) band 62.
- the sensing head 54 is positioned laterally parallel to the user's finger tip. The user may thus manipulate the handle with one hand and rotate the sensing head 54 so that the detector 56 is in contact with the finger tip on the other hand to which the device 50 is attached. The user may then manually locate their external cervical os and. once located, may rotate the sensing head 54 in an opposite direction so that the detector 56 is actually positioned therewithin. Once positioned within the external cervical os, the user may operate button 52-4 and thereby obtain a reading indicative of the refractive index of the cervical mucus (which thus correlates to the user's ovulation period).
- the sensing head 54 is most preferably formed of a biomedically compatible plastics material in which a stainless steel base plate 64 of the detector 54 is embedded.
- the detector 54 extends upwardly from the base plate 64 and includes a cylindrical sensing post section 66 and a convexly domed locator head section 68 most preferably unitarily formed from the same fluorocarbon polymer.
- a central stainless steel support member 70 having a generally rectangular shaped cross-section is embedded within the fluorocarbon polymer forming the cylindrical post 66.
- the opposed sides of the central support member 70 are convexly curved so as to correspond to the curvature of the post 66 and are polished to provide a reflective surface for the light traveling through the light guide regions 66-1 and 66-2 (see FIGURE 21).
- a 90° angled reflector 72 having a pair of support arms 72-1 , 72-2 and an angular cap 72-3 is provided so that the cap 72-3 is positioned over the top of the support member 70. Light being refracted along the light guide 66-1 will thus be redirected to the light guide 66-2 by virtue of the angular cap structure 72-3.
- the light guide regions 66-1 and 66-2 thus establish surfaces corresponding to the active window surfaces of the post 66. Placement of the detector 54 in a woman's external cervical os will therefore permit the cervical mucus to come into contact with the active surfaces of the light guides 66-1 and 66- 2 so that refractive index measurements may be detected by comparing the amount of light which is refracted back to the photoreceptor PR to the amount of light emitted by the light source LS. It will be observed that, although convexly curved, the light guides 66-1 and 66-2 have a substantially constant thickness dimension.
- a 2 x 2 inch square of sample material was cut from a sheet of 1000L FEP Teflon® film (0.010 inches thick) manufactured by DuPont High Performance Films, which reportedly was made from NP-40 FEP resin of Daikin Industries, Ltd.
- the sample was heat-treated using a laboratory heat-treatment/quenching press.
- the press had a pair of heated platens for melting a sample and a pair of freezing platens for rapidly quenching the sample.
- the tested sample was heated for 45 seconds between the hot platens at 657°F, then quenched between the quench platens immersed in liquid nitrogen (minus 320°F).
- a transfer arm enabled the hot mold containing the sample to be swung rapidly between the heated and the quench platens.
- Each pair of platens included a stationary platen and a platen that was attached to the piston rod of an air cylinder to allow the platens to be opened and closed rapidly.
- the air cylinders also provided a force that kept the mold flat and in intimate contact with the platens.
- the sample itself was contained within a mold comprised of a silver/stainless steel/silver sandwich structure. Initially the sandwich is loosely held together by small screws at the periphery, but the force of the platens and the adhesion of the molten sample keep the sandwich together during processing.
- the top layer of the sandwich was a polished sheet of 99.9% silver (Fine Silver) having a thickness of 26 gage (0.016 inches) before polishing and had a rectangular geometry, 3 inches by 3.5 inches which was lapped flat and polished on both sides.
- One side of the silver contacted the platen; while the other side acted as the top surface of the mold for the sample.
- the side facing the sample must be polished to ensure that the sample will have a smooth surface after melting and quenching.
- the reverse side was polished to give good contact with the platen for high heat transfer capability.
- the middle layer of the sandwich was 0.010 inch thick shim stock (stainless steel alloy AISI 302) having a 2-inch square hole which formed the sides of the mold. The thickness of the shim stock establishes the final thickness of the sample. The shim stock extends laterally from the sandwich and was attached rigidly to the transfer arm.
- the bottom layer of the sandwich was another sheet of Fine Silver. It is similar to the above described top sheet except that it formed the bottom of the mold.
- the hot platens were made of aluminum (alloy 6061 ). For each platen, the surface that contacted the mold sandwich was a 3-inch square which was lapped and polished for good heat transfer capability. Each hot platen had (2) 200 watt cartridge heaters and were controlled in parallel by a rheostat control so that temperature could be adjusted for optimum conditions. Temperature was measured with a surface contact thermometer. There was also provision for leveling the lower platen so that the platen surfaces are parallel when the mold sandwich is squeezed between them.
- the cold platens were made of copper (alloy 110, 99.9% pure) so as to provide sufficient heat transfer during quenching. It is important that there is sufficient mass of copper to absorb the quantity of heat from the sample and sample mold to achieve quenching.
- the required heat capacity is governed by the mass of the pieces and the following thermal processes: heat of solidification of the sample, cooling of the sample, cooling of the silver plates and cooling of the stainless steel shim stock.
- heat of solidification of the sample cooling of the sample, cooling of the silver plates and cooling of the stainless steel shim stock.
- the surface that contacted the mold sandwich was a 3-inch square which was lapped and polished for high heat transfer capability.
- the bottom platen resides in a stainless steel pan.
- the bottom platen was partially immersed in liquid nitrogen with only the top surface protruding by approximately 0.25 inches until the nitrogen boiling is minimal.
- the top platen was machined with a 1 inch deep well in its top surface. Before the melting/quenching process began, this well was filled with liquid nitrogen until the nitrogen boiling is minimal.
- the time dependent cooling of the platens was characterized using a themocouple embedded in a Teflon ® fluoropolymer sheet squeezed between the platens. Whenever the nitrogen boiling became minimal, the measured temperature was below -315°F.
- the quench platens and stainless steel pan of liquid nitrogen were surrounded by a double layer box of 0.775 inch Styrofoam® (1.55 inches total).
- a device employing a detector similar to that depicted in FIGURES 1-4 was constructed in order to investigate refractometric measurements using sucrose solutions.
- the detector comprised a transparent light conduit made of fluorinated ethylene propylene (FEP) positioned between a light emitting diode (LED) and a photodiode detector.
- FEP fluorinated ethylene propylene
- the light conduit portion of the detector was a portion of a Teflon ® FEP fluorocarbon film (DuPont) measuring 0.010" thick x 0.200" long x 0.200" wide.
- the clarity of the film had been increased by heating it above its glass transition temperature followed by a rapid quench into an aqueous solution of calcium chloride at approximately -49°C.
- the film was sandwiched between polished stainless steel sheets during heating and quenching to give two smooth faces, top and bottom, upon removal from the sheets.
- the bottom face of the film was then glued to two stainless steel supports separated by parallel channel 0.060" wide. The film was unsupported along the channel at its bottom surface thereby allowing air contact for the length of the film.
- a red LED (Panasonic LN21 CVAL(URS)) and a photodiode (Jameco Company P/N 112168) each of T 1-3/4 style were modified by cutting off their convex lenses and polishing them flat close to the anode wire and parallel to the embedded chip.
- the components were arranged such that the axis of the LED, axis of the FEP film light conduit and axis of the photodiode all coincided to allow the maximum light transmission through the FEP conduit to the photodiode.
- the components were epoxied in place. Black paint was used to mask all light paths from the LED to the photodiode except for paths through the 0.060" x 0.010" x 0.200" conduit of the FEP film.
- the LED was wired in series with a 328 ohm resistor, and during testing, a regulated 9.00 volts was applied across the pair.
- the photodiode was wired in series with a 993 ohm resistor, and during testing, a regulated 9.00 volts was applied across the pair.
- the voltage across the LED/resistor pair remained constant, and the measured voltage across the resistor (7.23 volts) indicated a current flow of 22.0 milli-amperes through the series combination.
- the voltage across the photodiode varied in response to the refractive index of the medium against the top face of the FEP film. This voltage was measured by use of a multimeter (Fluke 8021 B).
- Characterization of the detector was made in a room whose temperature was controlled between 25.0°-25.4°C. 100 microliters of a particular solution was placed on the FEP film and immediately covered with a large, opaque cup to exclude ambient light. Readings were made within 30 seconds, and there was no measured change of the reading after covering. After each sample, the FEP film surface was rinsed with RODI water and dried with a tissue. The samples were measured in the following order: 2, 6, 1 , 10, 4, 8, 0% (set #1). After one hour, in which the power supply was left on, the samples were measured in the following order: 0, 1 , 2, 4, 6, 8, 10% (set #2); then immediately followed by: 2, 6, 1 , 10, 4, 8, 0% (set #3). Results are plotted in the graph of FIGURE 23.
- the graphs of FIGURE 23 shows some variation which may be due to residual fluid from previous samples or condensate on the underside of the conduit.
- the devices of this invention have been discussed in terms of their presently preferred embodiment, namely, as a means to detect in vivo hydration of cervical mucus.
- other end use applications may be identified by those skilled in this art. Suffice it to say, however, that the refractive index of the fluorocarbon polymer employed as the light guide must be matched to the refractive index range that is desired to be measured.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002351706A CA2351706A1 (en) | 1998-12-03 | 1999-12-02 | Refractometric device for the in vivo detection of fertile periods of ovulating females |
EP99965083A EP1146814A4 (en) | 1998-12-03 | 1999-12-02 | Refractometric device for the in vivo detection of fertile periods of ovulating females |
AU31072/00A AU3107200A (en) | 1998-12-03 | 1999-12-02 | Refractometric device for the in vivo detection of fertile periods of ovulating females |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/204,163 | 1998-12-03 | ||
US09/204,163 US6149591A (en) | 1997-02-21 | 1998-12-03 | Refractometric devices especially adapted for the in vivo detection of refractive indices of cervical mucus |
Publications (1)
Publication Number | Publication Date |
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WO2000032100A1 true WO2000032100A1 (en) | 2000-06-08 |
Family
ID=22756884
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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PCT/US1999/028482 WO2000032100A1 (en) | 1998-12-03 | 1999-12-02 | Refractometric device for the in vivo detection of fertile periods of ovulating females |
Country Status (5)
Country | Link |
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US (1) | US6149591A (en) |
EP (1) | EP1146814A4 (en) |
AU (1) | AU3107200A (en) |
CA (1) | CA2351706A1 (en) |
WO (1) | WO2000032100A1 (en) |
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US6324418B1 (en) * | 1997-09-29 | 2001-11-27 | Boston Scientific Corporation | Portable tissue spectroscopy apparatus and method |
US6591122B2 (en) * | 2001-03-16 | 2003-07-08 | Nellcor Puritan Bennett Incorporated | Device and method for monitoring body fluid and electrolyte disorders |
US8135448B2 (en) * | 2001-03-16 | 2012-03-13 | Nellcor Puritan Bennett Llc | Systems and methods to assess one or more body fluid metrics |
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Also Published As
Publication number | Publication date |
---|---|
CA2351706A1 (en) | 2000-06-08 |
EP1146814A1 (en) | 2001-10-24 |
US6149591A (en) | 2000-11-21 |
EP1146814A4 (en) | 2007-07-04 |
AU3107200A (en) | 2000-06-19 |
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