Mucus testing by bearing lubrication

(54) Name: Device for testing mucus from a body cavity to indicate ovulation

The invention relates to a device for determining the phase of the menstrual cycle and in particular indicating the rheological properties of body mucus, especially cervical mucus and / or oral mucus, for predicting the onset of and for indicating the occurrence of ovulation. The invention is thus associated with fertilization control. It has been concluded that mucus samples from the vaginal and oral cavities undergo distinct phase rheological changes during the menstrual cycle. Although the changes in the cervical mucus are much more noticeable than the changes in the oral mucosa, both changes are easily detectable. During the direct preovulation phase, during a period of one to three days of estrogen dominance, the mucus is profuse and watery. During the postovulation phase, during progestation, the mucus becomes less abundant and more viscous. In a healthy woman with normal menstrual cycles, ovulation usually occurs between the 12th and 14th days before the next menstrual period (and not after the previous period), which is well documented in the medical literature. Cervical mucus contains most water at the time of ovulation, more specifically 97-98% water, and is relatively water-poor at other times, containing only 80-90% water. The solid residue after drying can be from 2% during ovulation to 20% at other times, a tenfold increase. To predict ovulation on the basis

7409844-3 of the previous menstrual period by counting the number of days between the end of the previous period and the predicted mid-cycle ovulation phase (rhythm method) is flawed because it is impossible to predict the beginning of the next menstrual period It is possible to predict ovulation based on hormone changes in the blood or chemical changes in the mucus, but currently known methods for such analyzes are of value only in special cases because the methods are time consuming and costly. At present, there is no reliable on-site technology that can provide the necessary information to predict or confirm ovulation during or immediately after examination of a patient.

The main object of the invention is to provide a device for testing the body mucus by introducing the mucus between inner and outer bearing members, one fixed, the other loaded and. both with bearing surfaces of predetermined roughness, the occurrence or absence of mechanical movement being an indication of ovulation. The inner and outer bearing members can be separated from each other and from a holder so that they can be sterilized or exchanged. The movement between the bearing members is either a sliding or reciprocating movement. Normally, the slime is brought to one bearing surface while the bearing members are separately mounted, and the slime is spread between the bearing surfaces as the bearing members are assembled. In one embodiment, one of the bearing members is fixed to a suitable holder and the other is provided with a load member, such as a weight or spring, which exerts a sufficiently large force for relative movement if the easy-flowing mucus has been sampled during the ovulation phase, but insufficient force for Relative movement of the viscous mucus has been sampled at other times of the menstrual cycle. In another embodiment, one of the bearing members consists of an extension, an elongated probe for insertion into the vagina, which extension serves to recover a cervical mucus sample. In accordance with the invention, it has been discovered that the operation described above requires the bearing members to have inner and outer bearing surfaces each having an embodiment having countersinks and elevations having an average distance of 0.2-3.0 µm between the bottom of the countersinks and the tops of the elevations » the scientific basis for the said claim has not been established with certainty; it is likely that this specific surface roughness regulates sliding of the mucus relative to the bearing surfaces and ensures the presence of a predetermined shear in the mucus.

Embodiments of the invention are described in more detail below with reference to the accompanying drawings. Fig. 1 is a perspective view of a device according to the invention, assembled for carrying out

7409844-3 certain steps in a method according to the invention. Fig. 2 shows the device of Fig. 1 with separate parts for carrying out certain steps in a method according to the invention. Fig. 3 shows an auxiliary instrument useful for carrying out certain steps according to the invention. Fig. 4 shows another auxiliary instrument useful for carrying out certain steps in the method according to the invention. Fig. 5 is a front view of another embodiment of the device according to the invention; Fig. 6 is a side view of the device of Fig. 5. Fig. 7 is your cross-sectional view along the axis of a component useful in handling the device of Fig. 6. Fig. 8 is a front view of a further embodiment of the device according to the invention. Fig. 9 is a perspective view of a further embodiment of the invention with the parts separately mounted for carrying out certain steps in the method according to the invention. Fig. 10 is a perspective view of the device of Fig. 9 with the parts assembled for carrying out other steps in the method according to the invention.

The device of Fig. 1 has an inner bearing member 20, an outer bearing member 22, a load member 46, a holder 24 and markings 26. The holder 24 having a horizontal base 28 and a vertical plate 30 consists of a suitable plastic such as methyl methacrylate or polycarbonate. . The plate 30 has in its center a horizontally extending recess 32, the axis of which is perpendicular to the sides of the plate 30 and has a rectangular cross-section.

The inner bearing member 20 is in the form of a short cylinder which has an axially extending projection or wedge 34 and a forwardly extending cylindrical bearing surface 36. The wedge 34, which fits tightly and releasably in the recess 32, holds the axis of the bearing member horizontally when the bearing member 20 and the holder 24 are assembled. The outer bearing member 22 is in the form of a disc with an axially located front and rear parallel, flat surfaces 38, 40 and with an outer cylindrical portion 42 and with an inner cylindrical bearing surface 44. The outer bearing surface 36 and the inner bearing surface 44 fit tightly and rotatable with each other when the bearing elements 20 and 22 are assembled.

In accordance with the invention, each bearing surface 36, 44 has an embodiment with elevations and recesses having an average distance of 0.2-3.0 µm between the bottom of the recesses and the top of the elevations. The space or play between the bearing surfaces is 2.54 x 10^-4 - 0.254 mm and preferably 2.54 x 10 ² - 0.127 mm. Preferably, the axial thickness of the outer bearing member is 6.37 - 50.8 mm. Preferably, each bearing member consists of a dimensionally stable, sterilizable material, for example a glassy material such as glass, a metallic material such as stainless steel, or a plastic material such as methyl methacrylate.

A bore .45 extends through the periphery 42 and into the bore of the outer bearing member 42. An internally threaded sleeve 47 is frictionally secured to the bore 45, which sleeve consists of, for example, a plastic or metal. A weighted and threaded plug 46 is screwed into the sleeve 47 and is made up of, for example, metal. The plug 46 has an external screwdriver slot to allow precise adjustment of the plug relative to the outer bearing member shaft.

The markings 26 include an outward-facing arrow 50 on the outer bearing member 22 and an inward-facing arrow 52 on the plate 30. When the inner and outer bearing members are assembled and have mucus between their bearing surfaces, the plug 46 is in a position to induce pivotal movement of the outer bearing member. in relation to the inner bearing member. Near the arrow 52 on the plate 30 is a green dot 54 and in the vicinity of the outer bearing member 22 at 90 ° away from the green dot 54 is a red dot 56. The arrangement is such that when the mucus between the bearing surfaces is relatively watery, the plug 56 rotates the outer bearing member 22 clockwise so that the arrow 50 points to the red dot 56. However, if the mucus is relatively viscous, the plug 46 cannot rotate the outer bearing member 22, so that the arrow 50 still points to the red dot 54.

One way of using the device of the invention with sterile inner and outer bearing members 20, 22 is as follows. First, the inner bearing member 20 is assembled with the plate 30 by inserting the wedge 34 into the recess 32. Next, a sample of cervical mucus is extracted by inserting a disposable probe 60, which at its end has an elastic spoon 62, through the vagina cavity to contact the cervix to take a cervical mucus sample 63. Thereafter, this cervical mucus is transferred to one of the bearing surfaces 36, 44, and the inner and outer bearing members are assembled by fitting the outer bearing member 22 to the inner bearing member 20, the arrangement being such that the cervical mucus is erased between the bearing surfaces. The outer bearing member 22 is then manually rotated a predetermined number of times, usually from one to three times, until the arrows 50, 52 are aligned. The outer bearing member 22 is then released. The resting position of arrow 50 relative to green dot 54 and red dot 56 indicate the absence or occurrence of ovulation.

Alternatively, oral mucus, i.e. saliva, is removed from the mouth by means of an eye pipette 64 having a tube portion 66 and a tapered end 68 and a rubber ball 70. Saliva is applied to one bearing surface 36 ', 44 simply by manually compressing the ball 70 and injecting. saliva

7409844-3 through the opening 68. This method is otherwise identical to the previously described method.

The device of Figs. 5, 6 and 7 has a base 71 and a bed 72.

In the bed 72 is mounted a rod 74 which extends forwardly and receives a ring 76. The front end of the rod 74 and the inner periphery of the ring 76 form bearing surfaces of the type described above for the application of mucus. From the ring 76 extends a release member 78. A forward bracket 80 extends from the base 71 on which is mounted a finger 82 which is loaded for contact with the release member 78. The load is accomplished by a weight 84 supported by a screw 86 and adjustable by unscrewing the screw. A bar 87 is associated with the bar 74, which bar is in the form of a bar with a rubber outside 88. When the bar 87 is manually advanced from one end to the other in contact with the surface of the bar 74, the bar 74 rotates a predetermined number of turns.

In operation, with the ring 76 removed, mucus is inserted on the front end of the bar 74 by means of a spoon or an eyepiece of the type described in connection with the device of Fig. 1. Then the ring 76 is fitted at the end of the bar 74 and the strip 87 is manually moved from the one end to the other end along the periphery of rod 74 to rotate it. If the mucus is relatively watery, no rotation of the ring 76 will be developed and the release element 78 will not be affected. On the other hand, if the mucus is relatively viscous, twisting of the rod 74 causes the actuation of the release mechanism 78.

The embodiment of FIG. 8 is the same as the embodiment of FIGS. 5, 6 and 7 except that the trigger device 82, 84, 86 is replaced by a calibrated voltage transducer 90 which includes a trigger finger 92 loaded by a weight or spring or similar device. a memory pointer 96 and an indicator lamp 98.

The embodiment of Figs. 9 and 10 includes an elongated cylindrical probe 100, the front end of which has a reduced diameter cylindrical protrusion 102 which is separate from the rest of the probe by a shoulder 104. The leading end 106 of the protrusion 102 is rounded. The probe 100 is associated with a ring 108 with an inner bore 110 and front and rear flat, parallel surfaces 112, 114. The outer bearing surface of the protrusion 102 and the inner bearing surface of the bore 110 fit tightly together when the ring 108 and the probe 100 are assembled. From the periphery of the ring 108 extends a threaded rod 116 with a screw-on adjusting nut 118, said rod and nut forming an adjustable torque weight. Probe 100 and ring 108 consist of the same material as theirs

7409844-3 correspondences in Figures 1 and 2. Also, the dimensions and roughness properties of the projection bearing surface 102 and the bore bearing surface 110 are the same as their counterparts in Figures 1 and 2.

When using the device of Figures 9 and 10, the probe 100 is first inserted into the vagina cavity so that the projection 102 comes into contact with the cervix and retains a plurality of cervical mucus on its bearing surface. Thereafter, the probe 100 is retracted and assembled with the ring 108 such that the protrusion 102 is inserted into the bore 110, the retraction of the ring 108 being restricted by the shoulder 104. The cervical mucus is spread between the bearing surfaces of the bore 110 and the protrusion 102. While the user holds the probe 100 horizontally in one hand, he turns the rod 116 to the horizontal position with his other hand. When the rod 116 is then released, rotation or non-rotation of the ring 108 relative to the probe 100 occurs under the influence of the torque of the weights 116, 118. The menstrual cycle phase can thus be determined in accordance with the invention.

It should be noted that although the bearing members described have a rotational movement, bearing members having smaller and outer bearing members having reciprocating movement are within the scope of the invention, although such devices are smaller, preferred.