CA1051686A - Eccentric viscometer for testing biological and other liquids - Google Patents

Abstract

ECCENTRIC VISCOMETER FOR TESTING
BIOLOGICAL AND OTHER LIQUIDS
Abstract of the Disclosure A device for determining the rheological properties of a liquid comprises an inner bearing member having a horizontally disposed outer cylindrical surface and an outer bearing member having a horizontally disposed inner cylindrical surface, each cylindrical surface constituting a bearing surface of pre-determined grit. A liquid sample is introduced between the inner and outer cylindrical surface, which are disposed eccentrically relative to one another. Relative mechanical movement of the members, which is related to both shear and displacement of the liquid disposed between them, provides an indication of the rheological properties of the liquid.

Description

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~: Background of the Invention -: 1. Field of Invention:
The present invention relates to processes and devices for determining rheological properties of biological and other liquids. More specifically~ the present invention is directed to-, wards processes and devices for obtaining bodily mucus, chiefly cervical mucus and/or oral mucus, and for determining its viscoelastic ` properties in order to predict and indicate the inception and the presence of ovulation for conception control.

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2. Description of the Prior Art:
It has been found that mucus samples from the vaginal and oral cavities undergo distinct in-phase rheological changes during the menstrual cycle. Although the changes in the cervical mucus are much more noticeable than the changes in the oral mucus, both changes are readily determinable. During the immediate preovulatory phase under estrogen domination ~or a period of one to three days, the mucus ~s profuse and watery. During_ the postovulatory phase, under progestation, the mucus becomes less abundant and highly viscous. In healthy women with normal menstrual cycles, as is well documented in the medical literature, ovulation usually occurs between the 12th and 14th day prior to the next menstrual period. Specifically, cervical mucus is most hydrated (97 to 98% water) at the time of ovulation and is relatively dehydrated (80 to 90% water) at other times. The solid residue present after desiccation may range from 2~ during o~ulation to 20% at other times, a ten fold increase. Determining ovulation on the basis of the preceeding menstrual period, such as in the rythm method of counting the days ellapsed between the termination of the menstrual period and the presumed midcycle ovulatory phase, is prone to errors because of the great variability in the length:of the proliferative period, i.e.
between the end of the menses and ovulation. Although it is possible to predict ovulation on the basis of hormonal changes in the blood or chemical changes in the mucus, present pro-cedures for such anal~ses besides being lengthly and costly, do not provide immediate result. In consequance, these pro-cedures are utilized only in special cases. At present, there .. . . . . .

~5~6~6 are no known reliable on-the-spot techniques that are capable of providing the information necessary for prediction or confirmation of ovulation during or immediately following examination of a patient.

S Summary of the Invention The primary object of the present invention is to provide processes and devices for determining the rheological properties of biological and other liquids. Generally, the device comprises an inner bearing member having a hori~ontally disposed outer cylindrical surface and an outer bearing member havi,ng.a _ horizontally disposed inner cylindrical surface, each cylindrical surface constituting a bearing surface of predetermined grit.
A liquid sample îs introduced between the hori~ontally disposed outer cylindrical surface of the inner bearing member and the horizontally disposed inner cylindrical surface of the outer bearing member, the cylindrical surfaces being eccentrically oriented relative to one another~ One bearing member is fixed and the o~her bearing member is biased. Relative mechanical mo~ement of the bearing members, a rotational movement about eccentric bearing surface axes that is related to both shear and displacement of the liquid sample, provides an indication of the rheological properties of the liquid.

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It is another object of the invention to provide processes and devices for obtaining affd testing a bodily mucus sample in order to determine menstrual cycle phase by introducing the mucus sample between a horizontally disposed outer cylindrical surface of an inner bearing member and a horizontally disposed inner cylin-drical surface of an outer bearing member, the cylindrical surfaces being eccentrically oriented relative to one another. One bearing member is fixed and the other bearing member is biased, each cylin-drical surface constituting a bearing surface of predetermined grit.
Mechanical movement or the absence of such movement of the biased bearing member relative to the fixed bearing denotes the menstrual cycle phase and provides indicia of ovulation. The inner and outer bearing members are individually separable from each other and from a sùpport so that they can be sterilized or replaced. The motion between the bearing members is a rotational movement about eccentric bearing surface axes, each of which is horizontally disposed.
Ordinarily, the mucus is supplied to one of the bearing surfaces while the bearing members are disassembled from each other and the mucus is extruded between the bearing surfaces when they are assemb-led with each other. In one form, one of the bearing members isfixed on a~suitable support and the other is provided with a biasing member, e.g. a weight or a spring, which exerts sufficient force to cause relative movement when the highly fluid mucus has been sampled during the ovulatory phase but insufficient force to cause relative movement when the viscous mucus has been sampled at other times during the menstrual period. In another form, one of the bearing members is an extension .. ... .. . . . .. . . . .. . .
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of an elongated probe, which is inserted into the vaginal cavity and held against the external os. for retrieval of acervicalmucus spec-imen. In accordance with the present invention, it has been dis-covered that the foregoing operation requires that the bearing member have inner and outer bearing surfaces, each characterized by a surface finish having valleys and peaks of from 8 to 125 microinches in average valley to peak height. Such a surface finish, in various embodiments, is provided by precision grinding, machining or etching random valleys and peaks or machining or etching regularly spaced prismatic facets or the like. It is believed that this specific sur-face roughness controls slippage of the mucus with respect to the bearing surfaces and ensures the occurrence of predetermined shear within the mucus interior and displacement of the mucus between the eccentric surfaces.
Other objects of the present invention will in part be obvious and will in part appear hereinafter.
The invention accordingly comprises the processes and devices, together with their steps, parts and interrelationships, which are exemplified in the present disclosure, the scope of which will be indicated in the appended claims.
_ ief Description of the Drawings_ For a fuller understanding of the nature and objects of the present invention, reference is made to the following detalled . ,: . .
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description, which is to be taken in connection with the accompanying drawings, wherein:
Fig. 1 illustrates certain principles o the invention;
Fig. 2 illustrates certain principles of the invention;
Fig. 3 is a perspective view of a de~ice embodying the ~)resent invention, with parts-assembled for the performance of certain steps of a process of the present invention;
Fig. 4 is a sectional of the device of Fig. 3;
Fig. 5 illustra~es an auxilliary instrument useful in the performance of certain steps of the present invention;
Fig. 6 illustrates another auxilliary instrument useful in the performance of certain steps of the present invention;
Fig. 7 is a perspec~ive view of another device embodying the present invention, with parts disasse~bled ~o~.the performance of certain steps of the process of the pre~ent invention; and Fig. 8 is a perspective view-of-the-~evi-ce-of Fig.--~, wi~h--parts assembled for the performance of othex steps of the present invention.

Detailed Description of ~he Preferred Em~odiments The present invention provides processes and devices for determining the rheological properties of biological and other liquids involving horizontally disposed bearing ~urfaces that .. --6--... , . , . , . ' -!.. .. , . . :

~05~6 are eccentrically oriented with respect to one another. The basic principles of operation are believed to involve~
the shear of a liquid between two coaxial rotating surfaces and (2) the displacement of li~uid through the eccentric dis-position of two bearing surfaces which relates to resistance flow measurements in capillary viscometry.- The shear and displacement of the liquid occur at the same time. ~ -Parameters illustrating certa-in-principles of the in-vention are shown in Fig. 1, wherein R = radi~s of inner cylinder h = radius of outer cylinder c = clearance Q = angular velocity or displacement ~ = angle between a radius vector and the 2 axis e = eccentricity h = film thickness The film thickness h depends both upon the cleàrance c and --upon the eccentricity e. For c~R ~<1 h = c(l + E COS ~) where E iS the eccentricity ratio e/c In the present case, the radii, angular displacement (maximum of 90l and clearances are known as priori, but the ~iscosity and eccentricity ratio are not. Experimental data indicates that the eccentricity ratio is determined from the weight per unit area of the outer cylinder and the vi~cosity of the liquid measured, , : ' . . . :
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there being no relative motion between the cylinders and the liquid in immediate contact wi~ the cylinders. The eccentricity ratio is a constant when designi.ng the instrument and becomes variable when a liquid is introduced between the cylinders. In operation, the eccentricity decreases for liquids characteri~ed by low viscosity and increases for liquids characterized by high viscosity. Experimental data ~hows that the eccentricity ratio is larger for saliva than for cervical mucus using the same weight cylinder. By gelecting outer cylinders of predetermined mass, measurements within certain viscosity ranges may be performed-under near-optimal conditions for eccentricity ratio 'E torque to yield t~e largest numerical valves.
In a coaxial viscometer, the coefflcient of viscosity is defined as n~
where n = viscosity M = torque tmoment) Q = angular displacement in radians or angular velocity In a capillary-tube viscometer, the volume displaced per second is defined as V= ~P/n where V = displaced volume per second aP = pressure difference In the present case ~P i~ operationally analagous to M and n= ~P/V
In eccentric viscometry, the equation defining the coefficient of viscosity for a coaxial vi~c~meter and the e~uation defining volume displaced per second for a capillary-t~be vi6cometer combine to yield . ~ , .. . . .

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where M' = (f) V as well as coaxial movement.
As illustrated in Fig. 2, if the moment M is constant, the viscosity~1 of a liquid between the eccentric cylinder is obtained as a function of angular displacement. No angular dis-placement, position A as shown by the solid lines in Fig. 2, de-notes that the moment is insufficient to overcome the viscocity of the liquid and provides an indication that the viscosity is high. Maximum angular displacement,- position D as 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.
Referring now to Figs. 3 and 4, 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. Support 28, which includes a grip 32, a chuck 34 and a release mechanism 36, is composed of a suitable plastic such as methyl methacrylate or polycarbonate. Chuck 34 includes a cylindrical head 37 and a rearwardly extending shaft 39.
Head 37 is provided with a horizontally extending central opening 38 having a holder 40, example an "O" ring.
Inner bearing member 22 is in the form of a short cylin-drical rod having along its axis a rearward extension 42 and a for-ward cylindrical outer bearing surface 44. Extension 42, which re-movably fits into opening 38 and is snugly held therein by holder 40, maintains a horizontal orientation of the axis of :

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bearing member 22 when bearing member 22 and support 28 are assembled. Outer bearing member 24 is in ~he form of a ring having an axis along which are disposed forward and rearward parallel flat faces 46, 48 an outer cy~indrical periphery 50 and an inner cylindrical bearing surface 52. outer bearing surface 44 and inner bearing surface 52 snugly and rotatably fit each other when ~earing members 22 and.24 are assembled.
The bearing surfaces are orien~ed substantially horiæontal and are disposed eccentrically relative to one another, where-by a crescent shape gap 54 is formed b~tween outer bearing surface 44 and inner ~earing surface 52 when bearing members 22 and 24 are assembled, the gap being shown somewhat exaggerated for clarity~ That is, the weight of outer bearing member 24 is such that the upper regions of hori~ontally disposed outer bearing surface 44 o~ inner bearing member 22 is urged towards the upper regions of horizontally disposed inner bearing surface 52 of outer bearing member 24, 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 i5 dependent upon the wei~ht of outer bearing member 24 and the non-uniform and the changeable dimensions of gap 54.
In accordance with the present invention, each of bearing surfaces 44, 52 requir~s a surface finish ra~ging from 8 to 125 microinches in a~erage valley to peak height, Also, the difference between the diametral profiles 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 beaxing membar 22 ranges from 1/4 ~ ~O ~

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to 2 inches. The weight of outer bearing member 22 is in the range of 5 grams to 500grams and preferably from 10 grams to 50 grams. In one example, using oral mucus, the weiqht of outer be.aring member 22 is 10 grams. In another example, using cervical mucus, the weight of outer.bearing member 22. i5 48-grams.
Preferably each of the bearing members is composed of a dimension-ally stable, sterilizable material, for example,-a vitreous material such as glass, a metallic material such as stainless steel, or a plastic material such as methyl methacrylate.
Biasing member 26 includes an externally threaded rod 56 and an internally threaded weighted ring 58. Rod 56, which is composed.of plastic or metal for.example, is frictioaally secured within a bore 60 that extends through periphery 50 of outer bearing member 24. Ring 58, which is composed o~ plastic or metal for example, is turned onto rod 56~ The position of ring 58 with respect to the axis of outer bearing memb~r 24 can be adjusted precisely by turning the ring onto rod 56.
Grip 32 inclues a head 62 and a handle 64. Shaft 39 of chuck 34 is freely rotatable within a bearing 66 that is mounted to head 62. Release mechanism 35, which includes a trigger 68 and an extending arm 70, is pivotally mounted to handle 64. The tip of arm 70, which defines a brake, is received within a notch 72 that is formed in outer bearing member 24. When arm 70 and notch 72 are engaged, release mechanism 36 is in the locked position and when arm 70 and notch 72 are disengaged,.release mech anism 36 is in the unlocked position. Release mechanism 36 is .,: . . '': ; .

~0~6816 is biased in the locked position by means of a spring 74 whi~h is mounted to trigger 68, the locked position being shown in Fig. 3. When trigger 68 is pulled inwardly against spring 74, arm 70 disengages notch 72 and outer bearing member 24 is rotatable -with~respect to inner bearing member 22, release mechanism being in the unlocked position.
Indicia 30 include an outwardly directed arrow 76 on the free end of~shaft 39 and a scale 78 on a rearward face of head 62, 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, weighted ring 58 is in a position to cause rotar~ motion of the outer bearing member with respect to the inner bearing member when the release mechanism is actuated to the unlocked position. Initially, arrow 76 is pointing upwardly towards the zero marking on scale 78 as shown at 79. The arrangement is such that when the mucus between the bearing ~urfaces is highly water~, weighted ring 58 rotates outer bearing member 24 in a clockwise direction and arrow 76 remains pointed upwardly. On the other hand, when the mucus is highly viscous, weighted ring 58 is incapable o rotating outer bearing member 24, whereby arrow 76 moves clockwise 90 due to the rotational resistance~ The angular displacement of arrow 76 is a function of the relative viscosity of the mucus.

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In contrast to the opera-tional characteristics of a concentric viscometer, the operational characteristics of the eccentric vis-cometer of the present invention are such that: (1) the mucus, which is displaced when outer bearing member 24 rotates, offers rotational resistance in addition to conventional shear due to the eccentrically disposed bearing surfaces; (2) the weight of outer bearing member 24 resists the torque; and (3) the dimensions of gap 54 varies during rotation.
One process of the present invention involves the use of sterile inner and outer bearing members 22, 24 as follows. First, inner bearing member 22 is assembled with chuck 34 by inserting extension 42 into opening 38. Next, chuck 34 is rotated until arrow 76 points to the zero marking on scale 78. Next, a sample 80 of cervical mucus is obtained by inserting a disposable probe 82 having an 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 bearing surfaces 44, 52 and the inner and outer bearing members are assembled by fitting outer bearing member 24 onto inner bearing member 22, the arrangement being such that the cervical mucus is extruded between the bearing surfaces. Outer bearing member 24 is positioned so that arm 70 engages notch 72, the longi-tudinal axis of rod 56 being perpendicular with respect to the long-itudinal axis of handle 64. Then, trigger 68 is pressed inwardly and release mechanism 68 is actuated to the unlocked position.

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During the time of ovulation, the mucus is watery and the rot-ational resistance is minimum. In consequence, when release mechanism 36 is actuated to the unlocked position, rod 56 rotates clockwise and arrow 76 remains stationary. At other times, the mucus is highly viscous and the rotational resistance is maximum.
In consequence, when the release mechanism is in the unlocked posi-tion, rod 56 remains stationary and arrow 56 rotates clockwise.
Finally, the position of arrow 76, a comparative indication of viscosity, denotes the presence or absence of ovulation. In this process, the weight of outer bearing member 24 i~s 48 grams. The quantity of cervical mucus displaced as 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 measure-ment.
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 bearing surfaces 44, 52 simply by manually squeezing bulb 92 and extruding saliva through opening 90. This process otherwise is identical to that described above in connection with cervical mucus. In this process, the weight of outer bearing member 24 is 10 grams.
The embodiment of Figs. 7 and 8 includes an elongated cylindrical probe 100, at the forward extremity of which is a cy-lindrical extension 102 of reduced diameter that is isolated . '' , . ''' ~ ' : ', -, ' ' " . ' ' ' ' ' ': " ' '' ~ ', , ..` . .
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. .` j ' " ', ' ' ' ,, ~0~i86 from the remainder of the probe by a ~houlder 104. The forward extremity of extension 102 is rounded as at 106. Associated with probe 100 is an annulus 108 having an inner bore 110 and forward and rearward fla~ parallel faces 112, 114. The outer bearing surface of extension 102 and the inner bearing surface of bore 110 snugly fit each other when ring 108 and pro~e 100 are assembled, a crescent shaped gap 115 being formed between the bearing suraces. Extending from the periphery of 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. Probe 100 and ring 108 are composed of the same materials as are their counterparts in Figs. 3 and 4. Also the dimensions and grit characteris~ics of extension bearing surface 102 and of bore bearing surface 110 are the same as are their counterparts in Figs. 3 and 4~
In operation of the device of Figs. 7 and 8, first probe 100 is inserted into the vaginal cavity so that extension 102 contacts the cervix, by which a ~uantity of cervical mucus is retained on the bearing surface of extension 102. Next probe 100 is withdrawn from the vaginal cavity and is assembled with ring 108 so that extension 102 i5 inserted into bore 110 and rearward movement of ring 108 is limited by ~houlder 104. At this point cervical mucus is extruded between the bearing surfaces of bore 110 and extension 102. Then a nser, while holding probe 100 horizontally in one hand, moves shaft 116 into horizontal orientation with the other hand. Finally when shaft 116 is released, eccentric rotation of ring 108 relative to probe 100 .
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under the torque of weight 118 will or will not cccur.
Menstrual cycle phase thereby will be indicated in accordance with the present invention.
Since certain changes may be made in the present disclosure S without-departing from the scope of the-prese~t invention, it is intended that all matter described in the foregoi~g specifica-tion and depicted in the accompanying drawings be interpreted in an illustrative and not in a limiting sense.

Claims (14)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A device for testing mucus from a bodily cavity, said device comprising an inner bearing element and an outer bearing element constrained for relative eccentric rotational motion with respect to each other, means for biasing said elements for said eccentric rotational motion, and means for indicating the occurrence of such motion, said inner bearing element and said outer bearing element having inner and outer, horizontally disposed, cylindrical bearing surfaces, said relative motion being a rotational movement about eccentric bearing surface axes that is related to both shear and displacement of said mucus.

2. The device of claim 1 wherein the difference between the diametral profiles of said bearing surfaces ranges from 0.01 to 10.0 mils, a crescent shaped gap formed between said bearing surfaces.

3. The device as claimed in claim 1 wherein each of said bearing surfaces has a surface finish ranging from 8 to 125 micro-inches in valley to peak height.

4. A device for testing mucus from a bodily cavity, said device comprising a support, inner bearing means and outer bearing means constrained for relative eccentric rotational motion with res-pect to each other on said support, means for releasably holding at least one of said inner bearing means and said outer bearing means against said motion, means for biasing said inner bearing means and said outer bearing means for said motion, and means for in-dicating the occurrence of such motion, said inner bearing means and said outer bearing means having inner and outer, substantially horizontally disposed, cylindrical bearing surfaces, said re-lative motion being a rotational movement about eccentric bearing surface axes that is related to both shear and displace-ment of said mucus, each of said bearing surfaces having a sur-face finish ranging from 8 to 125 microinches in valley to peak height.

5. The device of claim 4 wherein the difference between the diametral profiles of said bearing surfaces ranges from 0.01 to 10.0 mils, a gap formed between said bearing surfaces.

6. The device as claimed in claim 5 wherein said gap is crescent shaped.

7. The device of claim 4 wherein said inner bearing means is rotatably mounted to said base and said outer bearing means is rotatable eccentrically on said inner bearing means.

8. The device of claim 4 wherein said inner bearing means and said outer bearing means are detachable from said support and from each other in one phase of operation and being attached to said support and to each other in another phase of operation.

9. The device of claim 4 wherein said means for indi-cating includes indicia on one of said bearing elements and indicia fixed in operation with respect to said support.

10. A process for testing mucus from a bodily cavity, said process comprising the steps of placing said mucus on one of an inner bearing element and an outer bearing element, constraining said inner bearing element and said outer bearing element for re-lative eccentric rotational motion with respect to each other, biasing said elements for said motion, and indicating the occurrence of such motion, said inner and outer substantially horizontally disposed, cylindrical bearing surfaces, said re-lative motion being a rotational movement about eccentric move-ment about eccentric bearing surface axes that is related to both shear and displacement of said mucus, each of said bearing surfaces having a surface finish ranging from 8 to 125 microinches in valley to peak height.

11. The process of claim 10 wherein the difference be-tween the diametral profiles of said bearing surfaces ranges from 0.01 to 10.0 mils.

12. A device for testing mucus from a bodily cavity, said device comprising a support, inner bearing means and outer bearing means composed of glass, said inner bearing means and said outer bearing means constrained for relative eccentric rotational motion with respect to each other on said support, means for biasing said inner bearing means and said outer bearing means for said motion, means for releasably holding said inner bearing means and said outer bearing means against said motion, and means for in-dicating the occurrence of said motion, said inner bearing means and said outer bearing means having inner and outer cylindrical bearing surfaces, each of said bearing surfaces being substantially horizontal and having a surface finish ranging from 8 to 125 micro-inches in valley to peak height, said bearing surface disposed eccentrically relative to each other, said relative motion being a rotational movement about eccentric bearing surface axes that is related to both shear and displacement of said mucus, the difference between the diametral profiles of said bearing surfaces ranging from 0.01 to 10.0 mils, said means for indicating including indicia movable with at least one of said bearing elements and indicia fixed in operation with respect to said base.

13. The device of claim 12 wherein said support includes a grip and a chuck, said inner bearing member removable retained by said chuck.

14. The device of claim 12 wherein said support includes an elongated rod, said inner bearing member projecting from said rod and being substantially coaxial therewith, said rod providing a shoulder for limiting axial movement of said outer bearing member with respect thereto.