In most women menses occurs every 21 to 35 days, has a duration of 4 to 6 days and a volume of 30 to 80 ml. Excessive uterine bleeding (menorrhagia) is a common and distressing symptom. Its effect on the patient herself and her surroundings is great. Menorrhagia affects 15 % to 20 % of otherwise healthy women and can be indicative of cancer, endocrinological disorders or gynecological diseases.

Menorrhagia is technically defined as menses lasting longer than 7 days or a blood loss volume in excess of 60 to 80 ml. With volumes greater than 80 ml, the risk of sever anemia becomes rather high. In theory, menorrhagia can be precisely defined by the duration and volume of uterine bleeding; in fact, a woman's report of excessive bleeding, whether she describes it as"large amounts","clotting,"flooding", or"heavy use of tampons", has little correlation with the actual amount of blood lost. Fewer than half of women who complained of excessive bleeding actually had menstrual blood loss of more than 80 ml per menstrual period Treatment decisions in the management of Menorrhagia, Jo Ann Rosenfeld, Medscape Women's Health 2 (1), 1997].

An early study of bacterial vaginosis (BV) involved comparisons of the pH of vaginal fluids of women known to be suffering from BV with those known to be free of the disease. Gardner, H. L., et al., Am. J. Obstet.

Gynecol. 69: 962 (195O). All of the BV positive women in the study were determined to have a vaginal fluid pH greater than 4.5, and 91 % of these women had a vaginal fluid pH greater than 5.0. Of the normal (disease- free) women in the test, 92 % were found to have vaginal pH between 4.0 and 4.7. The conclusion drawn from the study was that a vaginal pH equal to or greater than 5.0 in conjunction with other clinical criteria was indicative of the presence of BV.

Ovulation is the process in which an egg matures and discharges from an ovarian follicle. In human ovulation is associated with rise in body temperature.

There is thus a widely recognized need for, and it would be highly advantageous to have an objective tool with which a clinician could measure the length of a period and the volume of blood loss associated with menses. Such a tool will assist in the diagnosis of gynecological disorders that eventuate in changes in the length of the period and the volume of blood loss associated therewith, see Chapple A, Ling M and May C. (1998) General practitioners'perceptions of the illness behavior and health needs of South Asian women with menorrhagia. Ethn. Health. 3 (1-2): 81-93, which is incorporated by reference as if fully set forth herein. In addition, there is a widely recognized need for, and it would be highly advantageous to have an objective tool with which a clinician could detect the presence and measure one or more substances in the vagina, e. g., hydrogen ions indicative of pH, amniotic fluid or a component thereof for detection of amniotic fluid loss during or before pregnancy, and/or sense one or more parameters of the vagina, e. g., temperature.

SUMMARY OF THE INVENTION Thus, it is an object of the present invention to provide a device, method and system for detecting the presence and measuring one or more substances in the vagina and/or for sensing one or more parameters of the vagina and wireless reporting information pertaining thereto outside the body of the user.

It is another object of the present invention to provide a device, method and system for measuring a vaginal parameter such as the pll, temperature and conductivity of menses or vaginal secretion and/or for measuring the presence and level of substances which may be present in menses or vaginal secretion, for diagnosing menorrhagia, menstrual cycle disorders and their causes; for predicting ovulation, the onset of menstruation, pregnancy, the presence of pathogens, or a variety of other conditions which are accompanied by a monitorable change in one or more parameters or substances in menses or vaginal secretion.

It is yet another object of the present invention to provide a device, method and system by which a clinician could measure the length of a period and the volume of blood loss associated therewith, thus facilitating the diagnosis of gynecological disorders that eventuate in changes in the length of a period and the volume of blood loss associated therewith. lt is still another object of the present invention to provide such device, method and system which would not further burden the woman who undergoes a diagnostic procedure therewith and would enable the ongoing logging of information pertaining to the length ouf a period and the volume of blood loss associated therewith that would be later retrieved and analyzed by the clinician.

It is still yet another object of the present invention to provide a device. method and system by which a clinician could detect at least one component present in or at least one parameter characterizing normal and/or anormal menses or vaginal secretion, including, but not limited to, compounds, microorganisms and/or toxins.

According to one aspect of the present invention there is thus provided a device for diagnosis of menorrhagia, menstrual cycle disorders and their causes, comprising (a) a menses-collecting article, e. g., insertable into a vagina or used externally for menses collection, such as a sanitary napkins; (b) at least one sensor for sensing a presence of menses in one or more distinct locations of the menses-collecting article for indicating a volume of menses secreted; and (c) a reporter being in data communication with the at least one sensor for reporting the presence of menses in the one or more distinct locations of the menses-collecting article.

According to further features in preferred embodiments of the invention described below, the reporter serves for recording information pertaining to the presence of menses in the one or more distinct locations of the menses-collecting article as an indication of the volume of menses collected in a time related manner. To this end the reporter includes a timer to time the replacements of the menses collecting article and the time took for the article to collect a determined volume of menses.

According to still further features in the described preferred embodiments the reporter serves for communicating the information to an analyzing unit.

According to another aspect of the present invention there is provided a system for diagnosis of menorrhagia, menstrual cycle disorders and their causes, comprising (a) a device including (i) a menses-collecting article, such as a tampon, or a sanitary napkin; (ii) at least one sensor for sensing a presence of menses in one or more distinct locations of the menses-collecting article indicating the volume of menses secreted; and (iii) a reporter being in data communication with the at least one sensor for reporting the presence of menses in the one or more distinct locations of the menses-collecting article, the reporter serving for recording information pertaining to the presence of menses in the one or more distinct locations of the menses-collecting article as an indication of the volume of menses secreted in a time related manner; and (b) an analyzing unit for receiving the information from the reporter and for analyzing the information.

According to yet another aspect of the present invention there is provided method of diagnosing menorrhagia, menstrual cycle disorders and their causes, comprising the steps of (a) inserting into a vagina or placing in direct contact therewith a device including (i) a menses-collecting article ; (ii) at least one sensor for sensing a presence of menses in one or more distinct locations of the menses-collecting article as an indication of the quantity of menses secreted; and (iii) a reporter being in data communication with the at least one sensor for reporting the presence of menses in the one or more distinct locations of the menses-collecting article ; and (b) retrieving and analyzing information pertaining to the presence of menses in the one or more distinct locations of the menses-collecting article.

According to further features in preferred embodiments of the invention described below, the data communication between the at least one sensor and the reporter is effected by direct communication.

According to still further features in the described preferred embodiments the data communication between the at least one sensor and the reporter is effected by remote communication According to still further features in the described preferred embodiments the remote communication is effected by a transmitter being in communication with the at least one sensor and a compatible receiver being in communication with the reporter.

According to still further features in the described preferred embodiments the reporter further serves for alerting a user when a pre condition is met. According to still further features in the described preferred embodiments the reporter includes an interface connectable to the analyzing unit for communicating the information.

According to still further features in the described preferred embodiments the reporter includes a transmitter and the analyzing unit includes a receiver for communicating the information from the reporter to the analyzing unit.

According to still further features in the described preferred embodiments the at least sensor includes a sensing unit being in the menses- collecting article.

According to still further features in the described preferred embodiments the at least one sensor includes a sensing unit being out of the menses-collecting article, whereas at least one liquid transfer article engaged within the menses-collecting article serves for directing the menses or a fraction thereof from the menses-collecting article to the at least one sensor.

According to still further features in the described preferred embodiments at least one of the sensors is designed to sense a presence of a specific component of the menses.

According to still further features in the described preferred embodiments the analyzing unit is selected communicable with a computer, so as to relay information stored therein to a computer system.

According to still another aspect of the present invention there is provided a device for sensing and reporting a presence of a substance or for measuring and reporting of a parameter in a vagina, the device comprising (a) an article shaped and dimensioned insertable into the vagina; (b) at least one sensor for sensing the presence of the substance or for measuring the parameter being carried by the article; and (c) a reporter being in data communication with the at least one sensor for reporting sensed or measured information pertaining to the substance or parameter outside the body.

According to an additional aspect of the present invention there is provided a system for sensing and reporting a presence of a substance or for measuring and reporting of a parameter in a vagina, the system comprising (a) a device including (i) an article shaped and dimensioned inscrtable into the vagina; (ii) at least one sensor for sensing the presence of the substance or for measuring the parameter being carried by the article; and (iii) a reporter being in data communication with the at least one sensor for reporting sensed or measured information pertaining to the substance or parameter outside the body ; and (b) an analyzing unit for receiving the information from the reporter and for analyzing the information.

According to yet an additional aspect of the present invention there is provided a method of sensing and reporting a presence of a substance or for measuring and reporting of a parameter in a vagina, the method comprising the steps of (a) inserting into the vagina a device including (i) an article shaped and dimensioned insertable into the vagina ; (ii) at least one sensor for sensing the presence of the substance or for measuring the parameter being carried by the article ; and (iii) a reporter being in data communication with the at least one sensor for reporting sensed or measured information pertaining to the substance or parameter outside the body; and (b) using an analyzing unit for receiving the information from the reporter and for analyzing the information.

The present invention successfully adresses the shortcomings of the presently known configurations by providing an objective tool with which a clinician can monitor the length of a period and the volume of blood loss associated therewith, and in addition to monitor various vaginal parameters such as pH and temperature which are indicative, for example, of bacterial vaginosis and ovulation, respectively, thus facilitating the diagnosis of gynecological disorders that eventuate in changes in the length of a period, the volume of blood loss associated therewith and the contents and characteristics thereof and/or with vaginal secretions.

Implementation of the device, method and system of the present invention involves perfonning or completing selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected steps could be implemented by hardware or by software on any operating system of any finnware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.

RRIFFDESCRIPTIONOFTHF.DRAWINGS The invention herein described, by way of example only, with reference to the accompanying drawings, wherein: FlGs. 1-3 are simplified schematic depictions of a device for diagnosing menorrhagia and menstrual cycle disorders according to the present invention; FIG. 4 is a simplilied schematic depiction of the communication between a reporter and an analyzing unit in a system for diagnosing menorrhagia and menstrual cycle disorders according to the present invention; and FIG. 5 is a simplifie schematic depiction of a conductive wetness sensor employed with the device for diagnosing menorrhagia and menstrual cycle disorders according to the present invention.

DESCRIPTION O15 THR PREFERRED EMBODIMENTS The present invention is of a device, system and method which can be used to objectively measure the length of a period and the volume of blood loss associated therewith, as well as the presence and level of components and parameters associated with menses vaginal secretions in healthy and disease conditions. Specifically, the present invention can be used to diagnose menorrhagia and menstrual cycle disorders and their causes.

The principles and operation of a device, system and method according to the present invention may be better understood with reference to the drawings and accompanying descriptions.

Bel-orne explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarde as limiting.

Referring now to the drawings, Figures 1-5 illustrate several preferred embodiments according to the present invention.

According to one aspect of the present invention there is thus provided a device for diagnosis of menorrhagia and menstrual cycle disorders, which is referred to hereinbelow as device 10.

Device 10 includes a menses-collecting article 12 either insertable into a vagina, like a tampon, or designed to be placed externally in contact therewith, like a sanitary napkin. Article 12, is preferably made of a rolled and compressed absorbent material, such as cotton, covered by a non-woven malerial. Alternatively, article 12 is non-absorbing or minimally absorbing, as described, for example, in U. S. Pat. Nos. 4,799,929; 5743893; and 5295984, which are incorporated by reference as if fully set forth herein.

Article 12 is typically substantially cylindrical, and is preferably equipped with a removing floss 14 protruding from its distal end 15 in a fashion similar to a conventional tampon device.

Device 10 according to the present invention further includes at least one sensor 16 (three sensors 16 are shown in Figures 1-3) for sensing the presence of menses or vaginal secretion, for sensing the presence and measure the level of a substance which may be present in menses or vaginal secretion, and/or for measuring a parameter, such as the temperature, electrical conductivity and/or electrical resistivity of menses or vaginal secretion as further detailed hereinunder, in one or more locations (three respective locations are shown in Figures 1-3) of menses-collecting article 12.

It is known that menses is deposited in the vagina from the cervix of the uterus and flows downward in the vagina toward the introitus. Thus the proximal end 17 of article 12 becomes wet first, and, in addition, the bottom side 18 of article 12 wets before the top 20 thereof ; due to the tendency of menses to flow along the floor of the vagina. Thus, by carefully selecting the locations within article 12 which are sensed by each of sensors 16, e. g., proximal-bottom, medial and distal-top locations, one can follow the wetness progressing within article 12 as described above. In fact, by knowing the capacity of article 12, one can use such a sensors arrangement to determine at any time point the amount of menses secreted and absorbed since the insertion of device 10 into the vagina. Similarly, a single sensor which measures electrical resistivity and/or conductivity can be employed to evaluate the amount of menses, or in full discharge learn about its ion content.

Device 10 according to the present invention further includes a reporter 22. Reporter 22 is in data communication with sensor (s) 16 and serves for reporting the presence of menses or vaginal secretion, the presence and level of a substance which may be present in menses or<BR> <BR> <BR> <BR> <BR> <BR> vaginal secretion, and/or the level of a parameter characteristic of menses or<BR> <BR> <BR> <BR> <BR> <BR> vaginal secretion. According to a preferred embodiment of the present<BR> <BR> <BR> <BR> <BR> <BR> invention reporter 22 further serves for recording information pertaining to<BR> <BR> <BR> <BR> <BR> <BR> <BR> the presence and level of a substance which may be present in menses or<BR> <BR> <BR> <BR> <BR> <BR> vaginal secretion, and/or the level of a parameter characteristic of menses or<BR> <BR> <BR> <BR> <BR> <BR> vaginal secretion in a time related manner. As used herein the term"time"<BR> <BR> <BR> <BR> <BR> <BR> refers also to the term"date". As further detailed hereinunder, according to<BR> <BR> <BR> <BR> <BR> <BR> a preferred embodiment of the present invention, reporter 22 further serves<BR> <BR> <BR> <BR> <BR> <BR> for communicating the information to an analyzing unit 24 (Figure 4).

An analyzing unit, such as unit 24, in combination with device 10 form a system for diagnosis of menorrhagia, menstrual cycle disorders and other vaginal disease and disorders according to the present invention.

Thus. the system includes a device such as device 10 described herein and an analyzing unit, such as unit 24 for receiving the information from the reporter and for analyzing the information.

Unit 24 can be, for example, a personal computer including a dedicated software for such analysis. The dedicated software can be developed by one ordinarily skilled in the art and is therefore only briefly described herein. In general, the dedicated software should be able to extract and analyze the information received from the sensors and provide the clinician with processed data relating, for example, to the duration of menses or vaginal secretion, rate of secretion, total volume of secretion, presence and level of specific secreted components, parameters characterizing the secretion, etc. The processed data can be presented textually or graphically, on a screen and can also preferably be printed. It is also preferably stored for future retrieval.

According to yet another aspect of the present invention there is provided method of diagnosis of menorrhagia, menstrual cycle disorders and their causes. The method is effected by executing the following method steps, in which, in a first step a device for diagnosing menorrhagia and menstrual cycle disorders, such as device 10 described herein, is inserted into or placed externally in contact with a vagina, the device includes (i) a menses-collecting article; (ii) at least one sensor for sensing a presence of menses in one or more distinct locations of the menses; and (iii) a reporter being in data communication with the at least one sensor for reporting the presence of menses in the one or more distinct locations of the menses- collecting article; and, in a second step information pertaining to the presence of menses in the one or more distinct locations of the menses- collecting article is retrieved and analyzed.

According to an additional aspect of the present invention there is provided a system for sensing and reporting a presence of a substance or for measuring and reporting of a parameter in a vagina. The system according to this aspect of the present invention includes a device which includes (i) an article shaped and dimensioned insertable into the vagina; (ii) at least one sensor for sensing the presence of the substance or for measuring the parameter being carried by the article; and (iii) a reporter being in data communication with the at least one sensor for reporting sensed or measured information pertaining to the substance or parameter outside the body. The system further includes an analyzing unit for receiving the information from the reporter and for analyzing the information.

According to yet an additional aspect of the present invention there is provided a method of sensing and reporting a presence of a substance or for measuring and reporting of a parameter in a vagina. The method according to this aspect of the present invention is effected by implementing the following method steps, in which, in a first step, a device including (i) an article shaped and dimensioned insertable into the vagina; (ii) at least one sensor for sensing the presence of the substance or for measuring the parameter being carried by the article; and (iii) a reporter being in data communication with the at least one sensor for reporting sensed or measured information pertaining to the substance or parameter outside the body; is inserted into the vagina, whereas in a second step an analyzing unit is used for receiving the information from the reporter and for analyzing the information.

The following sections describe several preferred embodiments of device 10 according to the present invention.

Thus, according to a preferred embodiment, and as specifically shown in Figure 2, the data communication between sensor (s) 16 and reporter 22 is effected, as indicated by 24, by direct communication, such as wire communication.

IIowever, according to another preferred embodiment. and as specifically shown in Figure 1, the data communication between sensor (s) 16 and reporter 22 is effected, as indicated by 26, by remote communication. The remote communication is effected by a transmitter 28 being in communication with sensor (s) 16 and a compatible receiver 30 being in communication with reporter 22. Transmitter 28 can be designed to be removably attached at distal end 15 of article 12 or to the underwear of the user or to her body, for multiple uses. A suitable interface is formed in this case to provide for connection between transmitter 28 and sensor (s) 16.

Transmitter 28 can include a power source 31, such as a battery, for its operation, which power source 31 can be used; to power sensor (s) 16 as well. The remote communication can be effected by the well known radio frequency technology or alternatively the surface acoustic waves (SAW) technology. as for example described in U. S. Pat. Nos. 5,760,525 and which are incorporated by reference as if fully set forth herein.

Transmitter 28 can be remotely energized by a remote energizing device 32, formed with, for example, reporter 22. Energizing can be effected every predetermined time interval and be of sufficient energy to activate sensor (s) 16 and transmitter 28 to sense and transmit the sensed information in such time intervals, say every several seconds, minutes or hours. Energizing can be effected, for example, by radio frequency (RF).

According to another preferred embodiment of the present invention reporter 22 further serves for alerting the user when a pre designated condition, such as that the capacity of article 12 to further absorb menses is low and it should be replaced, is met. Reporting according to the present invention can be effected in a variety of ways. For example, reporter 22 can include a signaling device 36. such as, but not limited to, a display 38 for reporting the information in a textual, graphical or numerical manner, and/or an alarming device 40, including, for example, a light source, e. g., a light emitting diode (LED), a sound generating device, or a vibrating or pricking device, for alarming the user. In a preferred embodiment reporting can be effected by more than a single reporting mode and a mode selector is provided to enable the user to select a desired reporting mode, for example, awakening modes (vibration, pricking or sound) during night time and intimate or personal modes (display, light or vibration) during day time. In any case, reporter 22 includes a power source 48, to provide power for its operation. It preferably further includes an on/off control button It will be appreciated that for diagnostic purposes a plurality of articles 12 are used during a single period. Each such article 12 is preferably communicating with a single reporter 22, which accumulates the data from all of which for further analysis. Each such replacement is recorded by reporter 22. Recorder 22 may be a cellular phone or a PDA device. In this case transmitter 28 is selected communicable with the cellular phone or PDA device.

According to still another preferred embodiment of the present invention, reporter 22 is a portable device carried or worn by the user. In a preferred embodiment it includes a wrist band 46: (proximal parts thereof are shown in Figure 1) and may therefore be worn on a wrist of the user.

Alternatively, it can be attached to the underwear of the user to her thigh or abdomen via, for example, an adhesive surface thereof.

According to yet another preferred embodiment of the present invention reporter 22 includes an interface connectable to analyzing unit 24 for communicating the information thereto. Alternatively, reporter 22 includes a transmitter 34 and analyzing unit 24 includes a receiver 36 for communicating the information from reporter 22 to analyzing unit 24.

According to still another preferred embodiment of the present invention, at least one of sensor (s) 16 is a conductive wetness sensor which includes, as shown in Figure 5, two metal plates 40 and an absorbent substance 42 intimately disposed therebetween, such that when absorbent substance 42 becomes wet, sensor 20 becomes conductive. Alternatively, a wetness sensor can be designed to have two metal wires whose ends are held together by a microscopic flax string, whereas when the string becomes wet it elongates, allowing the ends to separate thus braking a circuit.

As specifically shown in Figures 1-2, according to an embodiment of the present invention, each sensor (s) includes a sensing unit 50 being in absorbent menses-collecting article 12. Alternatively, as specifically shown in Figure 3, each of sensor (s) 16 includes a sensing unit 52, located external to menses-collecting article 12, whereas at least one liquid transfer article, engaged within menses-collecting article 12 serves for directing the menses from various locations in menses-collecting article 12 to sensor (s) 16.

According to still further features in the described preferred embodiments at least one of sensor (s) 16 is designed to sense the presence of a specific component included in menses or vaginal secretion. One example is given hereinabove, wherein the component is humidity or water content. Other examples include sensors adapted of detecting one or more substances such as, but not limited to blood, sugars, minerals, ions, salts, proteins, toxins, microorganisms, and the like, or one or more parameters, such as. but not limited to, temperature, wetness or pH. Miniaturized temperature, pH and other ions or salt sensors are well known in the art.

For example, a temperature sensor is adapted at sensing a heat magnitude and converting it into an electrical parameter (e. g., resistance, voltage, etc.) of a magnitude corresponding to the heat. Thermistors thus operating are distributed, for example, by Beta Therm Cat. # 1K7A1. A glucose sensor according to the present invention is preferably a glucose oxidase based glucose sensor which includes a potentiostat and an electronic chip for quantifying the glucose level in the menses. The operation of these components is well known in the art. Prior art glucose sensors are distributed by, example, LifeScan Inc. and McdiSense Inc. USA. Other sensors are also known in the art and can be miniaturized to fit into or be attached to article 12.

The present invention thus provides the first objective tool with which a clinician can measure the length of a period and the volume of blood loss associated therewith. The clinician can also be informed regarding the composition of menses and vaginal secretion.

Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modification and variations be apparent to those skilled in the art. Accordingly. it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.