GB1561987A - Devices for testing mucus from a body cavity - Google Patents

Description

(54) DEVICES FOR TESTING MUCUS FROM A BODY CAVITY (71) We, OVUTIME, INC., a corporation of the State of Massachusetts, U.S.A., having a usual place of business at 74 Standish Circle, Wellesley, Massachusetts, United States of America, do hereby declare the invention, for which we pray that a patent may be granted to us, and the method by which it is to be performed, to be particularly described in and by the following statement: This invention relates to a device for testing mucus from a body cavity.

British Patent No. 1,480,752 to which this is an Addition relates to a device for testing mucus from a body cavity, which comprises a shaft and ring assembled or capable of assembly with the ring positioned about, and capable of relative rotational movement with respect to, the shaft, the shaft and ring having, respectively, an outer bearing surface and an inner bearing surface which cooperate with one another when the shaft and ring are assembled; means for applying torque between the shaft and the ring when they are assembled; and means for indicating the occurrence of relative rotational movement between the shaft and the ring when they are assembled and when said means for applying torque is in operation, wherein (a) said bearing surfaces are of predetermined roughness, such that the clearance between said bearing surfaces when the shaft and ring are assembled is from 0.254 to 254 microns; and (b) the shaft and ring can readily be separated from one another after assembly.

According to the present invention, there is provided a device for testing mucus from a body cavity, said device comprising a bearing rod rotatably mountable in a bearing ring such that the centres of said rod and said ring are eccentric with respect to each other to provide a crescent-shaped gap between them for the retention of body mucus, there being provided a bias means for applying torque for causing eccentric rotational movement between said rod and said ring when said body mucus is in said gap, the difference between the diameters of the bearing surfaces of the rod and the ring ranging from 0.01 to 10.0 mils, each of the bearing surfaces of the rod and the ring having a surface finish ranging from 8 to 125 microinches in valley to peak height, and the rod and the ring being detached from each other in one phase of operation and being attached to each other in another phase of operation, the device further comprising an indicator to indicate said eccentric rotational movement.

For a better understanding of the invention and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which: Figure 1 is a perspective view of a device for testing mucus from a body cavity, with parts of the device assembled for the performance of certain steps of the process of testing, Figure 2 is a sectional view of the device shown in Figure 1, Figure 3 illustrates certain principles of the operation of the device, Figure 4 illustrates an auxiliary instrument useful in the performance of certain steps of the process, Figure 5 illustrates another auxiliary instrument useful in the performance of certain steps of the process Figure 6 is a perspective view of a second form of device for testing mucus from a body cavity, with parts of the device dismantled for the performance of certain steps of the process of testing, and Figure 7 is a perspective view of the device shown in Figure 6, with parts assembled for the performance of other steps of the process.

The devices illustrated are for use with processes for determining the rheological properties of mucus from a body cavity, the devices having horizontally disposed bearing surfaces that are eccentrically oriented with respect to one another. The basic principles of operation involve the shear of a liquid between two coaxial rotating surfaces and the displacement of liquid through the eccentric disposition of two bearing surfaces, which relate to resistance flow measurements in capillary viscometry. The shear and displacement of the liquid occur at the same time.

Referring to Figures 1 and 2, there is shown an eccentric viscometer 20 in the form of a torque-gauge comprising an inner bearing member 22, an outer bearing member 24, a biasing member 26, a support 28, and indicia 30. The support 28, which includes a grip 32, a chuck 34 and a release mechanism 36, is composed of a suitable plastics material such as methyl methacrylate or polycarbonate. The chuck 34 includes a cylindrical head 37 and a rearwardly extending shaft 39. The head 37 is provided with a horizontally extending central opening 38 having a holder 40, for example an "O" ring.

The inner bearing member 22 is in the form of a short cylindrical rod having along its axis a rearward extension 42 and a forward cylindrical outer bearing surface 44.

The extension 42, which removably fits into the opening 38 and is snugly held therein by the holder 40, maintains a horizontal orientation of the axis of the bearing member 22 when the bearing member 22 and support 28 are assembled.

The outer bearing member 24 is in the form of a ring having an axis along which are disposed forward and rearward parallel flat faces 46, 48, an outer cylindrical periphery 50 and an inner cylindrical bearing surface 52. The outer bearing surface 44 and inner bearing surface 52 snugly and rotatably fit each other when the bearing members 22 and 24 are assembled. The bearing surfaces are oriented substantially horizintally and are disposed eccentrically relative to one another, whereby a crescent-shaped gap 54 is formed between the outer bearing surface 44 and inner bearing surface 52 when the bearing members 22 and 24 are assembled, the gap being shown somewhat exaggerated for clarity.That is, the weight of the outer bearing member 24 is such that the upper regions of the horizontally disposed outer bearing surface 44 of the inner bearing member 22 is urged towards the upper regions of the horizontally disposed inner bearing surface 52 of the outer bearing member 24, the gap 54 being formed between the lower regions of the bearing surfaces. The eccentrically disposed bearing members 22 and 24 define a horizontally disposed eccentric viscometer, the operation of which is dependent upon the weight of outer bearing member 24 and the non-uniform and the changeable dimensions of gap 54.

Each of the bearing surfaces 44, 52 requires a surface finish ranging from 8 to 125 microinches in average valley to peak height. Also, the difference between the diameters of the bearing surfaces ranges from 0.01 to 10.0 mils and preferably from 1 to 5 mils. Preferably the axial thickness of outer bearing member 22 ranges from 1 to 2 inches. The weight of the outer bearing member 22 is in the range of 5 grammes to 500 grammes and preferably from 10 grammes to 50 grammes. In one example, using oral mucus, the weight of the outer bearing member 22 is 10 grammes. In another example, using cervical mucus, the weight of outer bearing member 22 is 48 grammes.Preferably each of the bearing members is composed of a dimensionally stable, sterilisable material, for example, a vitreous material such as glass, a metallic material such as stainless steel, or a plastics material such as methyl methacrylate.

The biasing member 26 includes an externally threaded rod 56 and an internally threaded weighted ring 58. The rod 56, which is composed of plastics or metal for example, is frictionally secured within a bore 60 that extends through the periphery 50 of outer bearing member 24. The ring 58, which is composed of plastics or metal for example, is turned on the rod 56 so that the position of the ring 58 with respect to the axis of the outer bearing member 24 can be adjusted precisely.

The grip 32 includes a head 62 and a handle 64. The shaft 39 of the chunk 34 is freely rotatable within a bearing 66 that is mounted in the head 62. The release mechanism 36, which includes a trigger 68 and an extending arm 70, is pivotally mounted in the handle 64. The tip of the arm 70, which defines a brake, is received within a notch 72 that is formed in the outer bearing member 24. When the arm 70 and notch 72 are engaged, the release mechanism 36 is in the locked position and when the arm 70 and notch 72 are disengaged, the release mechanism 36 is in the unlocked position. The release mechanism 36 is biased in the locked position by means of a spring 74 which is mounted on the trigger 68, the locked position being shown in Figure 1.

When the trigger 68 is pulled inwardly against the spring 74, the arm 70 disengages the notch 72 and the outer bearing member 24 becomes rotatable with respect to the inner bearing member 22, the release mechanism being in the unlocked position.

The indicia 30 includes an outwardly directed arrow 76 on the free end of the shaft 39 and a scale 78 on a rearward face of the head 62, the scale 78 being marked in gram-cm. When the inner and outer bearing members are assembled with mucus between their bearing surfaces and the release mechanism is in the locked position, the weighted ring 58 is in a position to cause rotary motion of the outer bearing member with respect to the inner bearing member when the release mechanism 36 is actuated to the unlocked position. Initially, the arrow 76 is pointing upwardly towards the zero marking on the scale 78 as shown at 79.

The arrangement is such that when the mucus between the bearing surfaces is highly watery, the weighted ring 58 rotates the outer bearing member 24 in a clockwise direction and the arrow 76 remains pointed upwardly. On the other hand, when the mucus is highly viscous, the weighted ring 58 is incapable of rotating the outer bearing member 24, whereby the arrow 76 moves clockwise 90 due to the rotational resistance. The angular displacement of the arrow 76 is a function of the relative viscosity of the mucus.

The working of the viscometer discussed above is further illustrated in Figure 3. If the moment M is constant, the viscosity of a liquid between the eccentric cylinder is obtained as a function of angular displacement. No angular displacement, position A as shown by the solid lines in Figure 3, denotes that the moment is insufficient to overcome the viscosity of the liquid and provides an indication that the viscosity is high. Maximum angular displacement, position D shown by the dashed lines, denotes that the moment is sufficient to overcome the viscosity of the liquid and provides an indication that the viscosity is low. Intermediate positions B and C reflect values between the two and serve to indicate the approaching time of minimal viscosity.

The viscometer can be used for obtaining and testing a body mucus sample in order to determine menstrual cycle phase by introducing the mucus sample into the viscometer. Mechanical movement or the absence of such movement of the biased bearing member relative to the fixed bearing member denotes the menstrual cycle phase and provides indicia of ovulation.

Referring now to Figure 4, one process involves the use of sterile inner and outer bearing members 22, 24 as follows. First.

the inner bearing member 22 is assembled with the chuck 34 by inserting the extension 42 into the opening 38. Next, the chuck 34 is rotated until the arrow 76 points to the zero marking on the scale 78. Next, a sample 80 of cervical mucus is obtained by inserting a disposable probe 82 having a elastomeric scoop 84 at its extremity through the vaginal cavity into contact with the cervix in order to retain the sample of cervical mucus. Next, this cervical mucus is transferred to one of the bearing surfaces 44, 52 and the inner and outer bearing members are assembled by fitting the outer bearing member 24 onto the inner bearing member 22, the arrangement being such that the cervical mucus is extruded between the bearing surfaces.The outer bearing member 24 is positioned so that the arm 70 engages the notch 72, the longitudinal axis of the rod 56 being perpendicular with respect to the longitudinal axis of the handle 64. Then the trigger 68 is pressed inwardly and the release mechanism 68 is actuated to the unlocked position. During the time of ovulation, the mucus is watery and the rotational resistance is minimal. In consequence, when the release mechanism 36 is actuated to the unlocked position, the rod 56 rotates clockwise and the arrow 76 remains stationary. At other time, the mucus is highly viscous and the rotational resistance is maximal. In consequence, when the release mechanism is in the unlocked position, the rod 56 remains stationary and arrow 56 rotates clockwise.

Finally, the position of the arrow 76, a comparative indication of viscosity, denotes the presence or absence of ovulation. In this process, the weight of the outer bearing member 24 is 48 grams. The quantity of cervical mucus displaced as the ring 58 travels in a 90 degree arcuate path is in the range of 3 mg to 5 mg, the mucus being positively displaced without homogenation of the mucus or the destruction of its viscoelastic properties during the measurement.

Referring to Figure 5, in an alternative process, oral mucus, i.e. saliva, is removed from the mouth by an eye dropper 86 having a tube 88 with a restricted end 90 and an elastomeric bulb 92. Here, saliva is applied to one of the bearing surfaces 44, 52 simply by manually squeezing the bulb 92 and extruding saliva through the opening 90. This process otherwise is identical to that described above in connection with cervical mucus. In this process, the weight of the outer bearing member 24 is 10 grams.

The embodiment of Figures 6 and 7 includes an elongate cylindrical probe 100, at the forward extremity of which is a cylindrical extension 102 of reduced diameter that is isolated from the remainder of the probe by a shoulder 104. The forward extremity of the extension 102 is rounded as at 106. Associated with the probe 100 is an annulus 108 having an inner bore 110 and forward and rearward flat parallel faces 112, 114. The outer bearing surface of the extension 102 and the inner bearing surface of the bore 110 snugly fit each other when the ring 108 and probe 100 are assembled, a crescent shaped gap 115 being formed between the bearing surfaces. Extending from the periphery of the ring 108 is a threaded shaft 116 having turned thereon an adjustable nut 118, the shaft and the nut serving as an adjustable torque weight.The probe 100 and ring 108 are composed of the same materials as are their counterparts in Figures 1 and 2. Also the dimensions and surface finish characteristics of the extension bearing surface 102 and of the bore bearing surface 110 are the same as are their counterparts in Figures 1 and 2.

In operation of the device of Figures 6 and 7, the first probe 100 is inserted into the vaginal cavity so that the extension 102 contacts the cervix, by which a quantity of cervical mucus is retained on the bearing surface of the extension 102. Next the probe 100 is withdrawn from the vaginal cavity and is assembled with the ring 108 so that the extension 102 is inserted into the bore 110 and rearward movement of the ring 108 is limited by the shoulder 104. At this point cervical mucus is extruded between the bearing surfaces of the bore 110 and extension 102. Then a user, while holding the probe 100 horizontally in one hand, moves the shaft 116 into horizontal orientation with the other hand. Finally when the shaft 116 is released, eccentric rotation of the ring 108 relative to the probe 100 under the torque of weight 118 will or will not occur.

Menstrual cycle phase thereby will be indicated.

WHAT WE CLAIM IS:- 1. A device for testing mucus from a body cavity, said device comprising a bearing rod rotatably mountable in a bearing ring such that the centres of said rod and said ring are eccentric with respect to each other to provide a crescent-shaped gap between them for the retention of body mucus, there being provided a bias means for applying torque for causing eccentric rotational movement between said rod and said ring when said body mucus is in said gap, the difference between the diameters of the bearing surfaces of the rod and the ring ranging from 0.01 to 10.0 mils, each of the bearing surfaces of the rod and the ring having a surface finish ranging from 8 to 125 microinches in valley to peak height, and the rod and the ring being detached from each other in one phase of operation and being attached to each other in another phase of operation, the device further comprising an indicator to indicate said eccentric rotational movement.

2. A device as claimed in claim 1 and further comprising a handle, from which the rod and the ring are detachable in said one phase of operation and to which the rod and the ring are attached in the other phase of operation.

3. A device as claimed in claim 1 or 2, wherein said difference between the diameters of the bearing surfaces of the rod and the ring range from 1 to 5 mils.

4. A device as claimed in claim 1, 2 or 3, wherein the axial thickness of said rod is in the range from i inch to 2 inches.

5. A device as claimed in any one of the preceding claims, wherein the weight of said rod is in the range of from 5 grammes to 500 grammes.

6. A device as claimed in claim 5, wherein the weight of said rod is 10 grammes.

7. A device as claimed in claim 5, wherein the weight of said rod is 48 grammes.

8. A device as claimed in any one of the preceding claims, wherein said rod and said ring are both made of a vitreous material, a metallic material or a plastics material.

9. A device as claimed in any one of the preceding claims, wherein said bias means comprises an externally threaded rod, which is engaged in the periphery of said ring, and an internally threaded weighted ring engaged on said externally threaded rod.

10. A device as claimed in claim 2 or any one of claims 3 to 9 as appendant to claim 2, wherein said handle is in the form of a support for said rod, means being provided on the support releasably to constrain relative eccentric rotational motion of the rod and the ring.

11. A device as claimed in claim 10, wherein said support includes a grip and a chuck, said rod being removably retained by said chuck in said support.

12. A device as claimed in any one of the preceding claims, wherein said rod is provided with a shoulder for limiting axial movement of said ring with respect thereto.

13. A device as claimed in any one of the preceding claims, wherein said indicator carries indicia.

14. A device as claimed in any one of the preceding claims, wherein said indicator is arranged to indicate direct rotation of said rod and relative eccentric rotation of said ring with respect thereto.

15. A device for testing mucus from body cavity, substantially as hereinbefore described with reference to any of the embodiments shown in the accompanying drawings.

16. A method of testing mucus from a body cavity, in which the mucus is placed in said crescent-shaped gap of the device as claimed in any of the preceding claims, and the occurrence or absence of relative rotational movement between the rod and ring during said one phase of the operation is noted as an indication of the viscosity of the mucus.

17. A method of testing mucus from a body cavity using the device as claimed in any one of claims 1 to 16, substantially as hereinbefore described with reference to any of the embodiments shown in the accompanying drawings.

**WARNING** end of DESC field may overlap start of CLMS **.

Claims (17)

**WARNING** start of CLMS field may overlap end of DESC **. In operation of the device of Figures 6 and 7, the first probe 100 is inserted into the vaginal cavity so that the extension 102 contacts the cervix, by which a quantity of cervical mucus is retained on the bearing surface of the extension 102. Next the probe 100 is withdrawn from the vaginal cavity and is assembled with the ring 108 so that the extension 102 is inserted into the bore 110 and rearward movement of the ring 108 is limited by the shoulder 104. At this point cervical mucus is extruded between the bearing surfaces of the bore 110 and extension 102. Then a user, while holding the probe 100 horizontally in one hand, moves the shaft 116 into horizontal orientation with the other hand. Finally when the shaft 116 is released, eccentric rotation of the ring 108 relative to the probe 100 under the torque of weight 118 will or will not occur. Menstrual cycle phase thereby will be indicated. WHAT WE CLAIM IS:-

1. A device for testing mucus from a body cavity, said device comprising a bearing rod rotatably mountable in a bearing ring such that the centres of said rod and said ring are eccentric with respect to each other to provide a crescent-shaped gap between them for the retention of body mucus, there being provided a bias means for applying torque for causing eccentric rotational movement between said rod and said ring when said body mucus is in said gap, the difference between the diameters of the bearing surfaces of the rod and the ring ranging from 0.01 to 10.0 mils, each of the bearing surfaces of the rod and the ring having a surface finish ranging from 8 to 125 microinches in valley to peak height, and the rod and the ring being detached from each other in one phase of operation and being attached to each other in another phase of operation, the device further comprising an indicator to indicate said eccentric rotational movement.

2. A device as claimed in claim 1 and further comprising a handle, from which the rod and the ring are detachable in said one phase of operation and to which the rod and the ring are attached in the other phase of operation.

3. A device as claimed in claim 1 or 2, wherein said difference between the diameters of the bearing surfaces of the rod and the ring range from 1 to 5 mils.

4. A device as claimed in claim 1, 2 or 3, wherein the axial thickness of said rod is in the range from i inch to 2 inches.

5. A device as claimed in any one of the preceding claims, wherein the weight of said rod is in the range of from 5 grammes to 500 grammes.

6. A device as claimed in claim 5, wherein the weight of said rod is 10 grammes.

7. A device as claimed in claim 5, wherein the weight of said rod is 48 grammes.

8. A device as claimed in any one of the preceding claims, wherein said rod and said ring are both made of a vitreous material, a metallic material or a plastics material.

9. A device as claimed in any one of the preceding claims, wherein said bias means comprises an externally threaded rod, which is engaged in the periphery of said ring, and an internally threaded weighted ring engaged on said externally threaded rod.

10. A device as claimed in claim 2 or any one of claims 3 to 9 as appendant to claim 2, wherein said handle is in the form of a support for said rod, means being provided on the support releasably to constrain relative eccentric rotational motion of the rod and the ring.

11. A device as claimed in claim 10, wherein said support includes a grip and a chuck, said rod being removably retained by said chuck in said support.

12. A device as claimed in any one of the preceding claims, wherein said rod is provided with a shoulder for limiting axial movement of said ring with respect thereto.

13. A device as claimed in any one of the preceding claims, wherein said indicator carries indicia.

14. A device as claimed in any one of the preceding claims, wherein said indicator is arranged to indicate direct rotation of said rod and relative eccentric rotation of said ring with respect thereto.

15. A device for testing mucus from body cavity, substantially as hereinbefore described with reference to any of the embodiments shown in the accompanying drawings.

16. A method of testing mucus from a body cavity, in which the mucus is placed in said crescent-shaped gap of the device as claimed in any of the preceding claims, and the occurrence or absence of relative rotational movement between the rod and ring during said one phase of the operation is noted as an indication of the viscosity of the mucus.

17. A method of testing mucus from a body cavity using the device as claimed in any one of claims 1 to 16, substantially as hereinbefore described with reference to any of the embodiments shown in the accompanying drawings.