US20110190580A1 - Analysis engine within a network supporting intravaginal monitoring - Google Patents

Abstract

An intravaginal monitoring device in a supporting network, and including supporting devices such as servers, computing devices and phone (of both medical staff and patients), together participate to collect, exchange and display data relating to a female reproductive system. Therein, and within one or many of such systems, analysis operations are performed to at least assist in reaching conclusions relating to a status of the reproductive system under service. As input to the analysis operations, one or more of, for example, (i) current and historical sensor data of varying types such as imager, temperature, pH, glucose, EKG, etc.; (ii) general medical information; (iii) patient and medical staff input; and (iv) input from other medical systems or processes. The output of analysis operations at least assists in the drawing of intermediate and final status conclusions. Analysis operations are supported by various visual working environments tailored for patients, medical staff, and third party computing systems.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application incorporates by reference herein in their entirety and makes reference to, claims priority to, and claims the benefit of:
• a) U.S. Provisional Application Ser. No. 61/246,375 filed Sep. 28, 2009, entitled “Intravaginal Monitoring Device” by Ziarno et al.;
• b) U.S. Provisional Application Ser. No. 61/246,405 filed Sep. 28, 2009, entitled “Network
• Supporting Intravaginal Monitoring Device, Method and Post Harvesting Processing of Intravaginally Processed Data” by Ziarno et al.;
• c) U.S. Provisional Application Ser. No. 61/246,396 filed Sep. 28, 2009, entitled “Network Supporting Intravaginal Monitoring Device” by Ziarno et al.
• d) U.S. Provisional Application Ser. No. 61/290,792 filed Dec. 30, 2009, entitled “Network Supporting Intravaginal Monitoring Device, Method and Post Harvesting Processing of Intravaginally Processed Data” by Ziarno et al.; and
• e) U.S. Provisional Application Ser. No. 61/263,416 filed Nov. 23, 2009, entitled “Intravaginal Monitoring Architecture” by Ziarno et al.
• Also incorporated herein by reference in their entirety are:
• a) U.S. patent application Ser. No. ______ filed on even date herewith by Ziarno et al., entitled “Intravaginal Monitoring Device” client docket number PUS-L019-001;
• b) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Network Supporting Intravaginal Monitoring Device” client docket number PUS-L019-002;
• c) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Analysis Engine within a Network Supporting Intravaginal Monitoring” client docket number PUS-L019-003;
• d) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Monitoring Support Architecture” client docket number PUS-L019-004;
• e) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Therapy Device” client docket number PUS-L019-006;
• f) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Dimensioning System” client docket number PUS-L019-007; and
• g) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Optics Targeting System” client docket number PUS-L019-008; and
• h) PCT Patent Application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Monitoring Device and Network” client docket number PWO-L019-001.
BACKGROUND
• 1. Technical Field
• The invention generally relates to intravaginal monitoring devices, methods, and networks, as well as smart phone devices and tablets communicating with the intravaginal monitoring devices, smart phone and tablet devices communicating with other nodes on a network, as well as applications therefor.
• 2. Related Art
• Reproductive health covers a wide area of a female's health and it is of critical importance to be able monitor this aspect of a female's life. Monitoring of a female's reproductive health should begin during the teen years and proceed all the way through old age. However, a shortage of health care professionals and prohibitive cost makes it difficult to constantly monitor intravaginal conditions that include conditions that can be monitored via vaginal fluid discharges, discharges from the uterus that are exuded through the cervical canal into the vagina, cervical colors and color changes, ovulation related conditions, menopause related conditions, sexually transmitted diseases related conditions, and child birth related conditions. In addition to all these conditions, treatments and therapies also necessitate constant monitoring to determine their efficacy for various female health problems and events.
• These conditions arc typically monitored by a gynecologist or obstetrician by inserting a speculum and examining or inspecting the inside of the vagina, cervix, and uterus for the possibilities of the aforementioned conditions and efficacy of treatments. That is, patients need to visit the gynecologist or obstetrician routinely and these routine checkups needs to be done during visiting hours of the health care professionals (gynecologist or obstetrician). Travel is necessitated, relocation, the effort required to locate a new gynecologist, long lines in waiting rooms, potential embarrassment, all serve to discourage females from routinely having these checkups, and present potential dangers for the female in the event of a quickly deteriorating event or condition, e.g., Chlamydia infection, progression of a cancer to dangerous stages, preterm labor risk, and the like.
• For instance, the fluid discharge (e.g., non colored, colored, opaque, pussy) are indicate conditions such as normal (small amount of clear or slightly milky vaginal discharge), yeast infections, abnormal vaginal flora, menstrual cycle, menopause, infections or STD—sexually transmitted diseases—(much more discharge than normal, discolored discharge, or abnormal discharge). By way of example, STDs include HPV (Human Papilloma Virus)(white lesions on the cervix during active infection), Chlamydia (increased vaginal discharge), Gardnerella (grayish, foamy discharge, with a strong fishy smell),Candida(thick creamy whitish discharge, with a yeasty smell), Gonorrhea (yellow or greenish discharge with a strong smell),Trichomonas(TV) (a frothy discharge, sometimes a yellow-green color) and so forth. In addition externally and or internally, cysts, lumps and bumps, conditions related to in growing hairs, acne spots, and blocked glands are also be observed via inspections.
• These routine checkups become even more difficult when the female is in a remote location away from her home support group of doctors and other medical professionals such as mid-wives, gynecologists, obstetricians, and nurse practitioners (e.g. on holiday, secondment from a place of employment, travelling extensively for work) and this is even truer in the developing regions of the world where there are be no medical clinics or medical help for female located close to the female's home. These female are forced to proceed to the nearest town or village where a female's health care provider are he located. This involves hours or even days of travel by foot, train or bus further discouraging the female from seeking timely, needed medical care or treatment. In worn torn regions of the world, such travel can place the female at great risk of personal harm from roving bands of armed gun men, such as on the African continent.
• These and other exemplary limitations and deficiencies associated with the related art are more fully appreciated by those skilled in the art after comparing such related art with various aspects of the present invention as set forth herein with reference to the figures.
BRIEF SUMMARY OF THE INVENTION
• The present invention is directed to a device, apparatus and methods of operation that are further described in the following Brief Description of the Drawings, the Detailed Description of the Invention, and the claims. Other features and advantages of the present invention will become apparent from the following detailed description of the invention made with reference to the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic block diagram illustrating a gynaecological analysis engine incorporated into the intravaginal monitoring devices and its supporting network infrastructure; wherein the gynaecological analysis engine, having a database is associated with various gynaecological conditions, makes a first preliminary analysis of possible gynaecological conditions;
• FIG. 1bis a schematic block diagram illustrating an intravaginal monitoring device and its supporting network infrastructure; wherein the intravaginal monitoring device communicates via a communication interface to external devices and/or external servers via wired and/or wireless network pathways;
• FIG. 2 is a schematic block diagram illustrating various powering schemes for intravaginal monitoring devices, ofFIG. 1b;
• FIG. 3 is a schematic block diagram illustrating various sensor placement schemes for intravaginal monitoring devices, ofFIG. 1b;
• FIG. 4 is a schematic block diagram illustrating fluid flush cleaner on the surface of the cap, that cleans both the surface of the cap and the target area of intravaginal monitoring devices, ofFIG. 1b;
• FIG. 5 is a schematic diagram illustrating placement of the intravaginal monitoring device ofFIG. 1b,placed so as to face the outer surface of the cervix; wherein the device's cap or head takes images of the outer surface of the cervix as well as sensor readings via many built-in electronic sensors, to monitor the well being of a female (and/or developing fetus in case of the female being pregnant);
• FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device ofFIG. 1b;
• FIG. 7 is a schematic diagram illustrating data flow between intravaginal monitoring device(s) and various systems or devices within the supporting network infrastructure;
• FIG. 8 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's data view page;
• FIG. 9 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's record page;
• FIG. 10ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's queries page;
• FIG. 10bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's queries page;
• FIG. 11 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's mail page;
• FIG. 12ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's forum page;
• FIG. 12bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's forum page;
• FIG. 13 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's research page;
• FIG. 14ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's account page;
• FIG. 14bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's account page;
• FIG. 15ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's IMD setup page;
• FIG. 15bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's1MD setup page;
• FIG. 16 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's support page;
• FIG. 17 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's shopping page;
• FIG. 18ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a health care professional's patients page;
• FIG. 18bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a health care professional's patient's accounts view page;
• FIG. 18cis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a health care professional's patient's records view and invoicing page;
• FIG. 19 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a health care professional's patient's billing page;
• FIG. 20 is a perspective diagram illustrating an exemplary support architecture configuration for servicing a female reproductive system, wherein the service involves use of real-time analysis engine functionality in accordance with various aspects of the present invention.
• FIG. 21 is a schematic and perspective block diagram illustrating another possible support architecture employing gynecological analysis engine operations that may reside in one or more of a plurality of supporing devices and systems such as diagnostic equipment located at a health care facility.
• FIG. 22 is a schematic block diagram illustrating analysis engine operations within an intravaginal monitoring device (IMD), built in accordance with various aspects of the present invention.
• FIG. 23 is a schematic block diagram illustrating components of one embodiment of an analysis engine that may be found in whole or in part within one or more of the various devices and systems of a network supporting intravaginal monitoring, wherein the analysis engine illustrates various aspects of the present invention.
• FIG. 24 is a schematic block diagram illustrating an analysis engine such as that ofFIG. 23, placed at least in part within a server to illustrate server based analysis engine functionality along with other server operations related thereto, the server and underlying functionality built in accordance with various aspects of the present invention.
• FIG. 25 is a schematic block diagram illustrating another embodiment of analysis engine integration within a network supporting intravaginal monitoring, and built in accordance with and illustrative of various aspects of the present invention.
• FIG. 26 is a cross-sectional diagram(s) illustrating one of many possible variations in dimensions, contour, and orientations, i.e., form factors, of a cap and optics assembly of an IMD sized to correspond to various “form factors” of intravaginal and cervical regions. The IMD is inserted via a mostly axial direction of a vaginal channel.
DETAILED DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic block diagram illustratinggynaecological analysis engine135,165,175,185 incorporated into theintravaginal monitoring devices105 and its supportingnetwork infrastructure167,177,187 (communicatively coupled via wired and wireless communication pathways151 that includes153,155,157 and159); wherein thegynaecological analysis engine135,165,175,185, having a database that has association with various gynaecological conditions, makes a first preliminary analysis of possible gynaecological conditions. In specific, based upon correlations with prior known results of various conditions that include normal conditions, sexually transmitted diseases and pregnancy related conditions, thegynaecological analysis engine135,165,175,185 conducts preliminary analysis and arrives at preliminary conclusions. Once the preliminary conclusions are arrived at, thegynaecological analysis engine135,165,175,185, via systems it is incorporated into (such as the supporting server177), intimates to the respective healthcare professionals and user. This allows the healthcare professionals (who cannot afford to inspect minute by minute data from theintravaginal monitoring devices105, because of having not enough time or resource allocation) to arrive at a final diagnosis very quickly and proceed with timely, treatment procedures thereafter.
• The supportingserver177, in conjunction with thegynaecological analysis engine135,165,175,185, also provides a forum with which a user can join a community of users, pharmaceutical professionals and even doctors, nurses and/or mid-wives. To facilitate this functionality as well as increase the probability of arriving at accurate conclusions, theintravaginal monitoring devices105 and its supportingnetwork infrastructure167,177,187 also utilize generalmedical information131,161,171,181 and incorporate (possibly, health care professional prescribed treatments) information from supportingmedical systems133,163,173,183. The supportingmedical systems133,163,173,183 may include laboratory testing for pathogens, genetic material testing, blood testing, blood pressure, temperature, electrocardiogram results and so forth, of the user.
• To further increase the probability of arriving at accurate conclusions, during analysis, thegynaecological analysis engine135,165,175,185 also utilizes data collected via a questionnaire that is specifically designed to determine the patient's history (that, in part, may also he obtained via generalmedical information131,161,171,181 and supportingmedical systems133,163,173,183). The questionnaire may be in a tree structure that helps narrow down possible conditions, in addition to having access to sensor data. Then, thegynaecological analysis engine135,165,175,185 provides referral to different gynaecologists (to choose from), and options of call back, sms, email and so forth, for appointment scheduling (and also, inform when the user need to visit a gynaecologist, for instance, in a week, in a month and so forth).
• In automatically arriving at conclusions, statistical analysis and conclusions on statistical bases arc also provided. For instance,95% chance that it is not serious,2% chance that it is one type of condition and3% another condition. To arrive at a conclusion (or range of conclusions), thegynaecological analysis engine135,165,175,185 may also utilize all of the available abovementioned information, at once. For instance, one particular color of the image and high or above normal range temperatures (local or systemic) for more than three days (in conjunction with patient's personal history, questionnaire information, other sensor data and so forth) is likely to indicate one particular condition. These analyses are completely done bygynaecological analysis engine135,165,175,185; while in other cases, it might be done by some gynaecologists (doctors) or other medical professional; such as in menstrual cycles and menopause (which have their own symptoms).
• Once such conclusion(s) are arrived at, thegynaecological analysis engine135,165,175,185 intimates both the user and corresponding gynaecologist (doctor) via email/SMS/MMS and/or by logging into the supportingserver177 website. This intimation may include a color or numbered importance scheme, for instance, the higher the number, the more is the importance of severity of a gynaecological condition. The color codes may include yellow or8 to10 (an immediate scheduling with healthcare professional is essential), red6 to8 (severe, but the user may schedule with doctor within a week's times), green and so forth. Moreover,gynaecological analysis engine135,165,175,185 also allows the user to ask questions, such as “What is the state of art kind of treatment available for this condition?” and so forth.
• Similarly, a gynaecologist's display shows: (a) Ability to see theimages 5 years back and correlate it with that of today's session; (b) Generate an image with every month one image in a play forward, backward, slow motion movement; (c) Video showing graphs with the sensor data; (d) Different color along with image; (d) Markers that gives ability to go anywhere in the timeline and expand over a region over a week, month, year; (e) Provisions for digital zoom in or zoom out) and so forth. It is appreciated that a video library regarding the progression of disease states can be created digitially. This provides a digital library for a specific patient and or group of patients that contains a wealth of powerful information. Comparisons are made for epidemiological data analysis, for time of onset of infection to onset of whole organism systemic affect, and the like.
• Moreover, when logging into the web pages of the supportingserver177, the gynaecologist (doctor) may look at the color or number code and determine which users should be given priority based on their case details, and the order in which users may be queued for examination and/or treatment. For instance, the gynaecologist may see a list of patients with yellow or8 to10 (at the top of the list) and may first wish to go through their cases immediately. Then, the gynaecologist may turn the attention toward other users (with yellow or green color coded) whose cases may not be as urgent.
• To make the analysis and arrive at conclusions quickly, thegynaecological analysis engine135,165,175,185 also utilizes the opinion of the user (and also that of the gynaecologists/healthcare professionals in a specialty or clinical sub-specialty, whether located locally or remotely). The opinions of the user may come from personal knowledge, experience, knowledge databases and encyclopaedias available in book form or on websites (including that in the support servers177), or via forums and discussions with other users (that are supported by the support servers177). To generate such a database, thegynaecological analysis engine135,165,175,185 uploads, stores and utilizes the images, sensor readings and prior healthcare professional's (gynaecologist's) diagnosis based upon these uploaded and stored data. In addition, where the images do not seem to correlate well (based upon an indication of changes that occurred), thegynaecological analysis engine135,165,175,185, makes a best judgement call (against prior known good condition of the user or even good condition of other people); and informs so to the user and gynaecologist. Treatment efficacy conclusions are also placed into the database, and can be reviewed by the analysis engine.
• The components ofgynaecological analysis engine135,165,175,185, supportingmedical systems133,163,173,183 and/or generalmedical information131,161,171,181 may in part or whole may be distributed anywhere betweenintravaginal monitoring device105 to supportingnetwork infrastructure167,177,187 (such asintravaginal monitoring systems105, iPods, cell phones,personal computers167,central support server177, gynaecologist's servers187).
• In all these, a nominal charge may be billed during registration by the user, and the rest of the revenues arc collected via billing the user by the gynaecologist (doctor) when a successful appointment is done. Revenues are also collected by ways of targeted advertising to the user and doctors, for instance, from the pharmaceutical companies. The following additional functionalities, billing and advertising scheme are also applicable. Similarly, charges are billed and collected for virtual doctor visits on-line by credit or debit card or by supplying insurance company billing information.
• The device and the nodes on the network described include functionality or modules to process and correlate intravaginal and extravaginal physiologic or personal use information with advertising related information such as cost per click (CPC) or cost per thousand impressions. Two primary models for determining cost per click: flat-rate and bid-based are used by way of example in the invention contained herein. In both cases the advertiser (e.g. a woman's consumer product marketer, a baby food vendor, a diaper's vendor), considers the potential value of a click from a given source. This value is based on the type of individual the advertiser is expecting to receive as a visitor to his or her website, (who's advertising is made directly on a remote device itself or intravaginal device) and what the advertiser can gain from that visit, e.g. revenue, product visibility. By way of example, an advertisement for baby diapers appears on a smart phone or computer (in a window or rotating advertisement banner or pop up) of an expectant mother or expectant father, this information is presented simultaneously with physiological (or other information from the device) on the smart phone or computer or in a separate window. In another variant, the advertising information is presented for a time out period and charged to the advertiser based upon the amount of time that the advertisement window, pop up or banner appears on the target's remote device. The device itself communicates with one or more nodes on the network to communicate the time the advertisement appeared on the expectant mother or father's smart phone or computer. Based upon the viewing time, or cost per click or cost per thousand impressions, the advertiser then gets billed for the advertising using a billing module based on one or more nodes of the network.
• In another variant of the invention, the flat-rate model module is used. A fixed charge is entered on one or more computers connected to nodes of the module that establish what will be paid for each click. This information, in one variant of the invention take from rate card database that lists the CPC within different areas of a website presenting data from the intervaginal device. These various amounts are often related to the content on pages displayed.
• In another variant of the invention, the hid-based model module is used on one or more nodes of the network to which data from the intravaginal device is communication. By way of example, the a software module is used to permit a first advertiser to compete against other advertisers in a private auction hosted by a website associated with said intravaginal device data or data collected from a plurality of intravaginal devices or, more commonly, an Internet based advertising network. Data on the network for each advertiser informs the host of the maximum amount that the advertiser is willing to pay for a given ad spot. The auction plays out in an automated fashion every time a visitor triggers the ad spot on the network to which the intravaginal device is communicatively linked.
• In another variant of the invention, the major advertising networks are connected to the network of a plurality of intravaginal devices and are communicatively linked. Contextual ad data is placed on the web properties of a 3rd-party to which the intravaginal devices are communicatively linked via the communication network. Publishers electronically sign up to host ads on behalf of the network. In return, they receive a portion of the ad revenue that the network generates, which can be anywhere from 50% to over 80% of the gross revenue paid by advertisers. These properties are often referred to as a content network and the ads on them as contextual ads. Advertisers are automatically and electronically billed and pay for each click they receive, with the actual amount paid based on the amount bid. An auction host charges a winning bidder just slightly more (e.g. one euro cent) than the next highest bidder or the actual amount bid, whichever is lower.
• To maximize success and achieve scale, automated bid management systems are deployed on the intravaginal device communications network of the present invention and include method steps to implement automated bid management and advertising systems on one or more nodes on the intravaginal device communications network. These systems can be used directly by the advertiser, or they used by advertising agency computer systems that offer PPC bid management modules as a service. These tools generally allow for computerized and automated bid management at scale, with thousands or even millions of PPC bids controlled by a highly automated system that is in communication with the intravaginal device communications network. The system generally sets each bid based on the goal that has been set for it, such as to maximize profit, to maximize traffic at breakeven, and so forth. The system is communicatively linked to the advertiser's website and fed the results of each click, which then allows it to set bids.
• By way of further example, a targeted advertising module is used in the present invention. Intravaginal device detects a female condition, e.g. a pregnancy, a sexually transmitted disease (STD), a precancerous condition, a cancer, a medical abnormality. This information is communicated to one or more nodes on the network. Advertising data for the treatment of the STD, e.g. for a drug used to treat the STD or other condition, from a particular pharmaceutical company or one or more companies, is then sent to the intravaginal device or other remote device on the network, for a user or doctor to review. Treatment option data are also communicated in another variant of the invention to the intravaginal device and or remote support device. With respect to pregnancy data, baby gift data or products used with babies are displayed on the intravaginal device or remote device. In yet another aspect of the information, a module is provided to mask, conceal or render anonymous the identity of a user of the intravaginal device while still permitting the information concerning the treatment for the user's condition, state or intravaginal event to be used for direct, targeted advertising to the user needing a particular drug or treatment regimen at the point in time when the user is suffering from a treatable condition or disease.
• In yet a further aspect of the invention (optionally using GPS functionality for locating or placing the intravaginal device, supporting device and/or user at a geographic location, e.g. or a remote device, (e.g. mobile phone communicating with the intravaginal device), patient candidate and drug recipient candidates data is collected. User specific condition or event data is collected on one or more nodes on the network and correlated to treatment advertising data, and or medical specialist, or hospital data. It is appreciated that drug companies will be able to provide targeted advertising data for their therapy options and/or drugs to exactly the users who are suffering from conditions or events at the time of need for treatment (beneficial treatments, e.g. drugs that treat STD's, drugs that treat cancers, additional screening or diagnostic tests to be taken, etc.)
• In yet other aspects of the invention, a user profile module, and a method of monitoring and controlling the spread of sexually transmitted diseases is provided. The user enters personal information, medical information, condition information, social information, e.g. the names of sex partner data, date and times of intercourse with specific partners, etc. This information is correlated with data collected from the intravaginal device. By way of further example, a sexually active female takes baseline data with the intravaginal device of the present invention. The data is time and date stamped, a record of the health or condition of her cervix is recorded on the device or one or more nodes of the network. She then has intercourse with a sex partner. In one scenario, if the partner is free of STDs a follow up record of the cervical or vaginal condition can be compared with the baseline data and archivally recorded. In another scenario, if the sex partner had an STD, then the user uses the device and notices that there are abnormal cervical and or vaginalchanges, and these are archivally recorded and or an alert is sent to a remote device, e.g. the user's or doctor's, and one or more of the advertising modules above is activated. Similarly, the sex partner is notified early of the STD condition. It is appreciated that the early notification of the condition for the user and the sex partner can stop the spread of the disease to other sex partners that may occur, e.g. in the case of HPV transmission. A timeline or relevant events is created on one or more nodes of the communication network, and appropriate treatment options and alerts arc provided to network supporting devices of specific users on the network.
• There are various types of support architectures that can be found operating within the supporting network infrastructure ofFIG. 1. For example, theIMD105 may operate entirely independent from all other supporting computers or devices, e.g., when out of range or when otherwise detached. As such, theIMD105 would be the only source of analysis engine operations. When attached, the IMD105 (or any other of the various IMDs that may be operating in the network infrastructure) might interact with any selected computing device located anywhere within the infrastructure (e.g., a computing device selected from one of the supportingpersonal computing devices167, the supportingservers177, and the medical supporting computing devices187). Together, the selected computing device and the IMD form a support architecture to service a female reproductive system via a communication link. The communication link can he a direct point to point link or comprise a network routed pathway, both as illustrated by the communication pathways151.
• A two device support architecture through which analysis engine functionality is provided might involve, for example, the IMD and a single one of the supportingpersonal computing devices167. It might also involve only the IMD and one of the supportingservers177. Similarly, a two device support architecture might involve the IMD and one of the systems/devices187. With any of these support architectures, the functionality of the analysis engine may be fully disposed solely within one of the two devices or distributed across both of the devices. For example, an IMD captures raw image data. It may also pre-process the data to generate measurement data. Lastly, after some initial analysis engine operations, the final processing by the analysis engine of the supporting device might take over with further analysis engine functionality.
• In other words, at astage1, raw sensor data from an IMD along with, perhaps, other medical data produced by other medical systems or devices, and manual input data is collected regarding a patient and their underlying physiology or physiologic state. At astage2, the raw sensor data from the IMD and, possibly, from other raw data from other medical devices, is pre-processed if necessary to generate measurement data therefrom. Atstage3, the analysis engine (or portions thereof) receives and processes the raw sensor data, retrieved data from other sources, manual input data, and measurement data, to either reach at least an intermediate assessment regarding the status of the reproductive system under service, or to reach a determination that further or supplemental input is needed. If needed, the analysis engine can either direct further operations of any supporting computing devices, IMD, etc., to automatically gather such needed information, automatically request delivery of further information or data from supporting systems or devices, or make requests (via supporting computing devices) to the patient, medical staff, or third parties therefor. After receiving any supplemental input, the analysis engine generates the at least the intermediate assessment (or again makes supplemental request cycling until it is able to make such assessment).
• After the at least intermediate assessment of a status relating to the reproductive system under service, various actions can take place. For example, medical staff might further interact with the analysis engine to verify or redirect the analysis engine operations to generate yet other assessment results. Alternatively, only a human's (medical staff's or patient's) verification might be applied. Either way, once thestage3 cycling ends, at astage4, automated actions based on such assessment can be carried out. Such automated actions might involve, for example, sending immediate notifications (along with underlying and relevant identification of the underlying female) to medical staff, ambulances, patient, patient's relatives (e.g., “Baby is on the way!”), pharma salespersons and other third parties. Such automated actions may involve human confirmation, and may be related to scheduling, transport, pharma or other treatment regime selection, etc. Automated actions may also involve sending control signals to the IMD or other medical equipment. Automated communications may take any of a variety of forms such as email, sms/mms, voice generation from text that is delivery via telephony networks to phones, letters, etc., and via the various visual working environments on the corresponding various supporting computing devices.
• The IMD may be configured to both provide the preprocessing of the raw sensor data it captures to generate measurement information (before analysis engine operations), and a beginning portion but not all of the analysis engine functionality. With the raw sensor data, measurement information and output from the beginning portion of the analysis engine functionality, a supporting device may then take over analysis engine operations and perform yet other portions or all of the analysis engine operations, i.e., produce a conclusory status assessment or provide information on through which a human can complete or verify the task. Likewise, the IMD may only send the raw sensor (including imager) data to the single supporting device which performs the entire sequence of the analysis system operations, without assistance from the IMD.
• Of course, three or more devices within a support architecture are also possible, and analysis engine operations can be spread across all of such devices or handled by one or a sub-group thereof. For example, in a three device configuration, an IMD and two computing devices, such as one of the supporting servers and a supporting personal computing device (by way of further example, a smart phone with an application running thereon), might interact to carry out the servicing of a female reproductive system. Over a series of sessions (insertion events on differing dates or times), the IMD might collect and forward to a supporting server for full analysis engine operations. A patient using the supporting personal computing device interacts with the supporting server to not only view the sensor data (e.g., images and video and temperature charts), but also to view resultant analysis engine output such as measurement information, rates of change, colorization analysis results, comparisons with such patients prior sensor data, prior analysis engine results, physiological condition profiles, alerts, etc.
• Final conclusions regarding the physiological status of the reproductive system under service may be entirely provided by one or more of the IMD and other computing devices in the network illustrated via analysis engine operations. In addition, medical staff or the patient themselves may provide manual input (via typing, etc.) into the process and either confirm or make the final determination regarding the physiologic status. To support this process, a visual working environment, via software application definition, is provided on all of the devices in the illustrated network. Through such visual working environment presented by one of the medical computing devices187, a doctor can interact to view the sensor data collected over the sessions along with output from the various stages of analysis engine operations to verify and supplement such operations, if needed. As a result, the analysis engine with or without doctor verification and input yields status information regarding the reproductive system under examination which is displayed in the visual working environment. Similarly, such a working environment may be provided to the patient and even other third parties for viewing the sensor data and analysis engine operation output, and may allow such persons an opportunity to assist and possibly enhance the analysis engine's performance.
• More particularly, the servicing of the female reproductive system in part involves capturing, exchanging, and displaying images generated from to the various types of raw sensor data and pre-processed measurement data, along with related “support information”, e.g., information from the supportingmedical systems133,183,163,173, supporting information from themedical information181,161,171,131 and manual input by the patient, medical staff and third parties. In addition, the servicing of the female reproductive system involves analysis engine operations which are based on such raw sensor data, pre-processed measurement data, and such “support information.” The analysis involves functionality such as: a) extracting usable information from the raw sensor data and pre-processed measurement data, changes over time, colorization information, etc.; h) identifying, gathering and applying selections from the “support information”; c) comparing prior session data received (that is, image and other sensor data received on perhaps a different day and from that produced by the same patient in the current day's session, and including multiple sensor data groupings for comparisons with such and other information where beneficial); cl) comparisons of such sensor data (including imager data) and “support information” along with intermediate stage results of the analysis engine operations with corresponding known status profiles and thresholds; and c) production of visual information (related to any of the previous elements) for use in various working environments displayed on the various computing devices throughout the network.
• In other words, the analysis engine output in some limited situations, e.g., such as when used with an IMD with limited functionality in a point to point link with a hand-held computer (perhaps both off-line from other device and 3rd party assistance), might involve a few preliminary steps or operations of the analysis engine only. Even so, such analysis system output, does provide better information than that of merely viewing a representation of the raw sensor data and, perhaps, pre-processed measurement data, and, as such, provides greater assistance in the drawing of conclusion regarding the physiological condition or status of a reproductive system under examination.
• The raw sensor data is often in a form that is not easily understood even when presented in a visual form. By pre-processing to generate measurement information, e.g., scaling or dimensioning information, such raw sensor data and measurement information can be used to produce more readily understood visual presentations. In addition, together they support a more detailed analysis by a human or the analysis engine in any attempt to draw conclusions (intermediate or final) regarding the status of the reproductive system under service.
• FIG. 1bis a schematic block diagram illustrating anintravaginal monitoring device1 and its supporting network infrastructure; wherein theintravaginal monitoring device1 communicates via acommunication interface21 to local external devices71 and/orexternal servers51,61 via wired and/or wireless network pathways31. In specific, the depiction shows flow of data between theintravaginal monitoring device1 and the supportingnetwork infrastructure71,51,61 viacommunication pathways33,35,37,39 and/or41. Essentially, this flow of data is meant to look into the image (or sensor) data collected within the memory (are be a built-in memory, flash memory, memory cards, and or one or more memory stick) of theintravaginal monitoring device1 and then deliver themes, for inspection, suggestions, annotations, readings, recommendations, discussions and/or as a basis for a treatment or therapy, to the user, health care professionals, user Internet or Intranet discussion forums, social networking sites where female share their experiences related to their reproductive health, or for secure storage at a data archive farm located externally from a plurality of intravaginal monitoring devices in the field, back up storage servers, and databases, private storage devices, Amazon(sm) storage device, EC2(sm) storage servers, alone or in combination. The data is sent in an encrypted form so as to be able to maintain the privacy of the female, that is, without the female's (user's) permission the data cannot be seen by anyone within the support network infrastructure. The data is decrypted at one or more nodes of the network. The system, network and nodes on the network serve to protect the privacy of the medical data in one mode of operation. Privacy is protected vis a vis third party interception of the data, which can include the female's private medical history, images of the female's cervix and other parts of her anatomy, et al.
• The data is reviewed by the user, health care professionals, and/or user forums only with user permission, in one variant, and the support infrastructure provides facilities to choose one or more user forums (to be able to discuss a reproductive health related problem, for instance), health care professionals (gynecologist or obstetrician) to receive treatments or for general checkups. The users may also wish to see the images (or, sensor readings) for one's own routine inspections and checkups of reproductive health, possibly in conjunction with health care professionals. Exemplary forums used in the invention include Facebook(sm), Twitter(sm), a social networking site, a private forum associated with a manufacturer of the intravaginal device, alone or in combination.
• For instance, the image and other sensor readings, of the intravaginal device, of an external electronic, wireless, monitoring patch applied to the skin of a female, alone or in combination (taken remotely from a medical facility, in one variant, and or taken within a medical facility or clinic, in another variant) allow the female, users of the forums, health care professionals, to inspect, suggest, annotate, create reports from the data, create electronic medical records, update electronic medical records, annotate the data, recommend, discuss and/or treat one or more of conditions and events related to: (a) Routine reproductive health; (b) Menstrual cycles, both normal and abnormal; (c) Menopause, and therapies related thereto, including but not limited to hormonal therapies; (d) Sexually transmitted diseases, and the efficacy of therapies therefore, e.g. drug therapies, cryo therapy; (e) Pregnancy checkups, and or (f) pre and/or post coitus periods. All of these checkups otherwise would necessitate the presence of the female in question at the health care professional's office, consuming valuable time and adding to needless health care costs. Using the intravaginal monitoring device101 and knowledge of reproductive health and well being (which is provided on a smart phone node or computer node of the network described herein) transferred over the Internet to the user, the female can observe the cervix and changes related thereto herself, her vagina (and the vaginal and or cervical discharges therefrom) and be able to use sensor readings taken by the intravaginal device or associated external device (and hence be able to judge health conditions and events, possibly, in conjunction with health care professionals). It is appreciated that early notification of an abnormal condition by the female herself or a health care professional leads to early treatment of the event or condition, e.g. cervical incompetence via suture therapy or cervical ring therapy, and a positive health outcome for the female. In variants of the invention, the intravaginal device and network provided herein provide early notification in patient pools at risk for a premature birth event or a threshold event, prior to which therapy or effective treatment can be provided, and an adverse event, e.g. premature birth, can be prevented.
• It is appreciated that the method of extending the term of a gestation cycle is provided herein. The method consists of providing early notification of an event associated with a probably premature birth using the intravaginal monitoring device and network described herein, and providing a therapy to extend the term of gestation of a being in a womb. The therapy is selected from the group consisting of a drug therapy, a medical device therapy, e.g. cervical ring, a surgical therapy, e.g. suturing the cervix shut, alone or in combination. In yet a further variant, post therapy monitoring is also provided by the device to determine the efficacy of the treatment or therapy. In one variant, a kit is provided comprising an intravaginal monitoring device and a therapy to extend the gestation period of a being in the womb. It is appreciated that extending the gestation period of a being in a womb, e.g. by weeks or months, has significant short term and long term benefits for the being in the womb, e.g. organ development proceeds further, increasing the likelihood of survival of the being in the womb, and the long term prognosis should the being in the womb be born.
• By way of further example, the method, system and network includes: a female utilizing intravaginal monitoring device and network described herein. The device monitors and tracks intravaginal physiologic conditions (e.g. whether there has been a release of waters (e.g. detecting a fast rush of anterior waters and or detecting a slow release of posterior waters), position of the cervix and or cervical channel (e.g. if it is anterior, posterior, or center (positioned for birth)), whether the cervix is ready for birth or not yet ready for birth, cervical dilation (e.g. absolute opening size of the cervical channel), the three dimensional shape of the cervix, e.g. cervical effacement, and optionally using an ancillary electronic measuring device externally measures other parameters, e.g. fetal heart rate, female's heart rate, tonus, e.g. uterine muscle contraction and or relaxation, provides data for a trace or digital indication of fetal EKG over time on a first graph, and provides data measuring contraction intensity (e.g. either using the intravaginal device, the external wirelessly communicating monitoring device, alone or in combination), (the graphs of EKG and contraction intensity are positioned one above another in one variant), and other sensor data described herein. An alert is sent to a remote device, e.g. the female's or the doctor's iPhone™ or computer over the Internet or cell phone network, once one or more of the parameters measured, alone or in combination, indicate a premature or normal birth condition or that a series or cascade of events detrimental to the gestation of the being in the womb have happened or are about to happen. In one variant, a doctor reviews the data collected calls the female to advise her to rush to a clinic for therapy or treatment. The female does so. The doctor or medical professional provides the female therapy, e.g. cervical suturing, drug therapy, bed rest, or application of a cervical ring. The therapy results in a longer gestation time of the being or fetus in the womb. The fetus continues fetal development, improving its chances at survival and normal in womb development. The intravaginal device is continued to be used post therapy to monitor the efficacy of the therapy in one variant. Should other abnormal events occur post therapy, the intravaginal device, network and method is again used to monitor events and conditions in one variant.
• Fluid discharge monitoring observed via a small moving image video clip (taken at distinct points in time and over a period of time) allows the female, users of the forum or health care professionals to identify reproductive health based upon one or more of (a) Small amount of clear or slightly milky vaginal discharge (considered to be normal); (b) Menstrual cycle discharges; (c) Menopause discharges; (d) infections or STD—sexually transmitted diseases—(much more discharge than normal, or discolored discharges). And in case of any observable discrepancies observed by the sensors or image comparison, during pregnancy or during normal occurrences of pre and post coitus (due to concerns about STD) or at all other periods, or upon periodic request by a health care specialist (gynecologist or obstetrician)(the device is remotely activated or placed into a mode of operation), the sensor readings and images obtained via theintravaginal monitoring device1 are be utilized in taking precautionary actions or advise the female to seek medical professional intervention.
• Theintravaginal monitoring device1 can communicate with the supporting infrastructures such as user's IMD (Intravaginal Monitoring Device) client systems71, supporting server(s)51 and/or supporting IMD (Intravaginal Monitoring Device) client systems anddevices61 in many different ways: (a) A memory stickintravaginal monitoring device1 and USB and or mini USB port within the client module (inside thepersonal computer77 or mobile phone or smart phone) assist in viewing the data contents on thepersonal computer77 and deliver directly to the supporting server(s)51 and viewed through web pages. To enable this, the intravaginal monitoring device1 contains a unique network ID; (b) The intravaginal monitoring device1 can be plugged directly to a television73 (or communicate with a wireless connection through an intranet wireless network connection or Internet connection) or personal computer77 display using display management10 and display driver (all of the software is driven by the display management10); (c) The intravaginal monitoring device1 can be plugged it into a personal computer77 (and the personal computer77 considers it as a memory device and copies all of the files and data from the intravaginal monitoring device1 to the personal computer (and optionally this can happen from the personal computer to the device1 in another variant), the personal computer77 uses memory device interface85 to do this); (d) The browser goes on to query mode and the website or server51 connects to the intravaginal monitoring device1 and pulls out information data (female subject data with time and date stamped data, unit data, software version data, etc.); and (e) A served up web page, real server module65 or locally populated server module (without connecting to the supporting server51) extracts information from the intravaginal monitoring device1 (the client module83 are not detect intravaginal monitoring device1, it arc be turned off). The data is pushed fromdevice1 in one variant onto the servers. In another variant, the data is pulled from thedevice1 upon interrogation of the device.
• These supporting local personal computing devices71 includecell phones75,personal computers77 andvideo recorder79, or simply an access point, for instance. Exemplary phones include the Apple™ brand, iPhone™, the Google™ brand, Android™, and Blackberry™ branded phones. Theintravaginal monitoring device1, while inserted in place (inside the vaginal channel) or after usage and removal, allows an authenticated supporting personal computing device71 to send control signals (as well as firmware and other logistical program codes) and receive images/video clips/sensor data and so forth from theintravaginal monitoring device1. In one variant, thedevice1 harvests and stores data in a memory on thedevice1 and has the wireless chip in standby mode or disabled mode. Once thedevice1 is removed from the vaginal channel, thedevice1 senses the removal of the device therefrom and once the device is outside the vaginal channel communication of the data via a wireless communication communicates the data from the device to remote devices. The data transfer mode of operation is also manually activated by a user once the device is outside the female's body. In another variant,device1 includes a sonogram mode of operation for imaging the position of the fetus head or other body parts. It is appreciated that periodic images arc taken bydevice1. These images provide useful data selected from the group consisting of the size and dimensions of the head or rest of the body of the fetus, the position of the fetal head or other body part in relation to the female's anatomy, etc.
• In other words, the communication is initiated by theintravaginal monitoring device1, upon removal from the vaginal channel, upon switching off theintravaginal monitoring device1, upon memory full, upon emergency situations, and upon communication button press (if there exists one) by the user. These logistical codes are built into theintravaginal monitoring device1; however, they might also be received from supportingservers51, by request. The receiving of images/video clips/sensor data are also be initiated remotely by supporting servers51 (as per certain logistics) or supporting intravaginal monitoring device client systems and devices61 (as per a health care professional's instructions or commands from a device used by a health care professional, for instance).
• In another embodiment,monitoring device1 and/or a smart phone, alone or in combination, establishes communication with the communication network, and during a set up mode of operation, initiates access to a web site node on the network that offers for sale or distribution an application or a group of applications. The user selects one or more application(s) from a list or category of offered applications, e.g. pregnancy monitoring application, high risk pregnancy monitoring application, STD detection application, fertility monitoring application, non-human animal estrus determination application, artificial insemination technician application, pre-cancerous cervical change monitoring application, menopause monitoring application, normal pregnancy monitoring application, labor and delivery monitoring application, lifetime female reproductive lifetime monitoring application, baby gift option application, fetal monitoring application, ovulation monitoring application, rhythm method birth control application, etc. The applications arc downloaded or uploaded from the communications network ontomonitoring device1, and/or smart phone, alone or in combination and marry themonitoring device1 and smart phone and make them operation nodes on the network. Sensor data is then sent from themonitoring device1, to the smart phone, and then onto other network nodes as prescribed in the application, by way of example. The applications further are operational for pre-set periods of time, e.g. 9 months for a pregnancy, 1 year for STD operation, and the like. After the pre-set periods of time, new applications or upgraded applications, or patient tailored applications, are uploaded onto the monitoring device and/or smart phone.
• To make all of the aforementioned functionality and flow of data possible, theintravaginal monitoring device1 contains a head orcap5,stem3,7 (that contains many of the electronic components including adisplay13, some or all of the sensors and batteries), bottom cap9 (that allows insertion and removal or recharging of batteries and exposes mini USB port for wired communications) and an on/offswitch15. The on/offswitch15 also allows independent selections of modes, wireless on/off, wired on/off (by keeping on clicking15 until the mode is selected). It also contains a server module (SM)11 and display management10 unit.
• The user's IMD (Intravaginal Monitoring Device) client systems71, in addition, containserver module81,client module83,memory device interface85 andapplication programming interface87. Similarly, the supporting IMD (Intravaginal Monitoring Device) client systems anddevices61 also contain server module91, client module93,memory device interface95 andapplication programming interface97. The supporting IMD (Intravaginal Monitoring Device)client devices61, for instance, are be a blood pressure monitor or thermometer, which could be in the patient's or health care professional's hands. Moreover, the sensor data can be supported by supplemental data, and the sensor data itself can be stored remotely from the support server(s)51, a supporting management company such as53,55,57 or supporting IMD (Intravaginal Monitoring Device) client systems anddevices61.
• For instance, a female purchasesintravaginal monitoring device1 kit, consisting ofintravaginal monitoring device1 as well as a dock where theintravaginal monitoring device1 can be placed for charging and for communications (alternatively, communication are also occur while in vaginal channel). The female also signs up with supporting server(s)51,53,55 or57 and in addition are also sign up for service from local/regional/remote health care professionals (which is possible via the supporting IMD (Intravaginal Monitoring Device) client systems and devices61).
• Then, to use theintravaginal monitoring device1, the female begins to follow the instructions provided within theintravaginal monitoring device1 kit, from the supportingservers51 and/or supporting IMD (Intravaginal Monitoring Device) client systems and devices61 (via the health care professionals from whom the female has requested service). The instructions arc streamlined for various specific circumstances that include routine checkups, menstrual cycles, menopause, sexually transmitted diseases and pregnancy checkups (are also include pre and/or post coitus periods).
• During the usage (while continuously wearing the device) or after usage, depending upon the aforementioned specific circumstances, based upon the permission given by the female (or other user), theintravaginal monitoring device1 transmits the captured images/video clips/sensor data to the supporting server(s)51 (via user's IMD client systems71 such as an access point,cell phone75 orcomputers77, for instance). Alternatively, the female also opts to watch these images/video clips/sensor data all by herself and decides whether to send them to the support server(s)51 (and then to the health care professionals via the supporting intravaginal monitoring device client systems and devices61), makes her own personal decisions, or discards the images/video clips/sensor data. These options are available to the individual female.
• Later, the female logs into her account in the supportingservers51, selectively uploads images/video clips/sensor data (electronic medical records or reports) of interest to her or the health care professionals and then give permission to the supporting IMD (Intravaginal Monitoring Device) client systems anddevices61 of the health care professionals for further investigation (of a routine occurrence or a specific condition, for instance). Alternatively, the female opts to access suggestions from other users, from another server (user forum servers, such as53,55 or57, for instance) by sending certain information stored in her account in the supporting server(s)51.
• Once the health care professionals gain access to the images/video clips/sensor data, electronic medical records, reports, etc., they are able to provide recommendations/treatments options via the same supporting server(s)51 back to the female. These recommendations/treatment options are communicated via emails or directly via the supporting server(s)51 (which is more secured). These cycles of monitoring and recommendations/treatments can be done routinely during routine checkups, menstrual cycle periods of time, menopause, sexually transmitted diseases and pregnancy checkups (are also include pre and/or post coitus periods), thereby saving the time of the female and the health care professionals.
• As described herein, he very same processes, devices, methods, networks, and analysis engines are used for female non-human animals; users of these are artificial insemination technicians, veterinarians, and animal husbandry professionals.
• FIG. 2 is a schematic block diagram illustrating various powering schemes for intravaginal monitoring devices, of theFIG. 1b.A typicalintravaginal device205 consists of a head orcup207, astem209 and a bottom cap. Near the bottom cap, there is an on/off switch that assists the user to switch on and off theintravaginal monitoring device205 and also selects various modes. The modes include WiFi on/off, WiMax on-off, various sensors on/off selections, and so forth.
• As depicted in theintravaginal monitoring device225, the bottom most part of the stem containsbatteries227.Batteries227 can be inserted or removed by unscrewing the stem bottom cap229 (that also contains on/off and mode switch231), or be rechargeable batteries. Still further down the bottom most part is anunscrewable cap233, which when unscrewed exposes a mini USB communication port or other suitable communication port. This port assists in communicating with local external devices or external servers via an access point. Alternatively, the bottom part are also consist of a Wi-Fi port, in which case thebottom cap233 acts as abattery227 insertions or removal opening.
• Thedepiction245 shows arechargeable battery247 variant ofintravaginal monitoring device245 that comes with acord253 to charge thebattery247. The depiction shows a Wi-Fi communication variant (other exemplary variants include WiMax communication functionality and circuitry, cellular phone communication functionality, Bluetooth communication functionality, etc.), but the unit also has a mini USB port (which exposes itself when thebottom cap249 is unscrewed). The depiction also shows an on/off ormode selection switch251.
• Finally, thedepiction265 shows another variety ofintravaginal monitoring device265 that comes with a rechargingdock283. When theintravaginal monitoring device265 is not in use, it can he docked in the rechargingdock283 and after few hours of charging of thebatteries271, theintravaginal monitoring device265 is ready for use again. Thedepiction265 also shows placements of few ofsensors267,269,279 and recharging plugs281.
• FIG. 3 is a schematic block diagram illustrates various sensor placement schemes for intravaginal monitoring devices, of theFIG. 1b.In specific, the depictions of305,325,345 and365 show placements of (video)camera309,347,sonogram315,335,electrocardiogram331,pressure329 andtemperature327,349,367 sensors and user interfaces that includes an on/off/mode selection switch313,333,353,373.
• In other words, theillustrations305,325,345 and365 show placement of electronic components, as they appear externally. The electronic components that appear from one side of the wearable (used for longer term monitoring) or non-wearable (in another variant)intravaginal monitoring devices305,325,345 and365 include conductive rings331 (the top one being on the surfaces of the cup orhead307 or337; through which electrical potential can be measured, for instance, in case of pregnancy, baby's EKG), electrolyte, PH, glucose sensors311 (these sensors, in reality, are not co-located), infrared temperature sensor window, plate forthermal temperature sensing327,349,367, microphone315 (for instance, piezo) affixed to either the inside or the outside of the cap (such that cap amplifies mother-fetus heartbeats or infant movement sounds), hermetically sealed on/off switch withfingertip texture313,333,353,373, light emitting display (for instance, indicating green on ready; red on servicing required—battery, storage full, etc.; no light indicating power off and so forth), and mini-liquid crystal display. Also note that all sensor positions illustrated are merely illustrative; any sensor could be located anywhere on intravaginal monitoring device housing or there within (if operational), or externally thereof Thedepiction345 also showbottom cap359 that can be sealed while screwing back355 (with awasher357 that makes theintravaginal monitoring device345 water resistant/proof).
• FIG. 4 is a schematic block diagram illustrating fluid flush cleaner on the surface of the cap that cleans both the surface of the cap and the target area of intravaginal monitoring devices, of theFIG. 1b.Specifically, the illustration depicts typical placement of few of theelectronic components419,423,425,417,457 within the hermetically sealedtransparent cap413,453 and stem421 that includes camera, an infrared thermometer and other sensors, processing circuitry and memory, communication and user interfaces andbatteries425, and a fluid flush cleaner415,455 on the surface of thecap413,453.
• The electronic components are placed over one or more circuit boards, such as the419. Thecircuit boards419 hold most of the electronic components that capture images and take sensory readings (from the front side of the outer surface of the cervix).
• The illustration also shows afluid tube427,459 for lens cleaning or sperm injection; whereas the depictedfluid tube427 is built internal to theintravaginal monitoring device443, thefluid tube459 is built removably outside of theintravaginal monitoring device473. Note that the squeeze rubber bulb/ball429 are either be filled with vinegar and water type solutions; alternatively, a syringe containing cleaning solution (or, sperm injection) as well is used. Moreover, the syringe attachment could also be used to deliver drugs. Likewise, instead of theexterior tube427 cleaning solution/sperm/drug could be stored in interiorintravaginal monitoring device473 cavity (for instance, within the stem421), with an injection grommet for initial delivery and pumping (or a pressurized cavity and valve). In addition, drain holes (when thecleaning system429,427,459 and415,455 is not used as a sperm delivery device) can be added to thecap411 for cleaning fluid delivery and vaginal-uterus discharges. Also note that thetube427 can assist in device insertion-removal.
• FIG. 5 is a schematic diagram illustrating placement of theintravaginal monitoring device511 ofFIG. 1b,placed so as to face the outer surface of thecervix543; wherein the device's cap orhead513 takes images of the outer surface of the cervix543 as well as sensor readings via many other built-in electronic sensors, to monitor the well being of a female (and developing fetus in case of the female being pregnant).
• Including pregnancy, a female's reproductive health that is observed using theintravaginal monitoring device511, directly or indirectly (by a gynecologist or obstetrician, to determine the health conditions), include theVulva521,Vaginal Channel531, Exterior Portion ofVaginal Channel533, Interior Portion ofVaginal Channel535,Cervix541, Outer Surface ofCervix543, Exterior Orifice (opening) ofCervix545,Interior Orifice547,Cervical Channel549,Uterus551,Fallopian Tube561, andOvary571.
• Theintravaginal monitoring device511 itself contains a cap or head513 (that contains most of the built in electronics), stem515 (that aids user in insertion/removal and stabilization/orientation during wear) and bottom cap (or, finger ring)517 that assists insertion/removal. Thestem515 is, in some configurations, also contains built in electronics. Thecap513 and stem515 are include one or more of camera and illumination system, sensors, user interfaces, power management system, communication interfaces. The sensors include temperature sensors, pressure sensor, glucose sensor, PH sensor, EKG sensor, ultrasound sensors, and sonogram sensor. Other sensor systems that assist in determining other gynecological conditions (and in cases of other needs for physiological reproductive data) are also contemplated. Theintravaginal monitoring devices511 are inserted in one variant by applying some lubricant on the surface of thecap513.
• Features that are incorporated in various embodiments of the intravaginal monitoring device511 of the present invention include: (a) a Camera unit containing wide angle lensing as well as “fish eye” lensing and image recovery; (b) Transparent latex or other biocompatible material is used to cover the device for use and to protect the lensing cap of some of the designs (this also extends the life of the medical grade rubber device); (c) Time stamping sensor data capture (to be able to follow up and investigate the vaginal conditions by a health care professional) is also provided in another variant; (d) Live video is used for guidance of the device into place and proper orientation for imaging desired anatomy; and (e) Linear, symmetric; device with a very flexible neck and stem to assist in fitting the space; and (f) Making the intravaginal monitoring device able to bend and face toward cervix (straight ahead, in a line of sight; note that a female moves the intravaginal monitoring device511 to orient it properly, an optional audible or visible alert is given to the user once the device detects it in a mode of operation that provides device assisted positioning—this can also be accomplished by viewing the images in an external device or with an algorithm on the device indicating to the user the device is properly imaging).
• In addition, there are two exemplary variants of theintravaginal monitoring devices511, the first one that is wearable (for continuously wearing during night or other periods, and for long term monitoring) and the second one is non-wearable (for shorter term monitoring and quick assessments at the gynecologist's office, for instance). These two types come in different shapes and sizes, depending upon their applications and the anatomy or events to be monitored in the female. One or more portions of the device are composed medical grade silicon for flexibility and adjustability of the cap or head or other suitable metal biocompatible material or plastic material, to snugly but comfortably fit into thecervix area543. Other types of plastics or rubber are also used herein, including hypoallergenic materials. Moreover, the cap513 (orhead513, shaped like a bulb) appear to be made of a flexible, medical grade silicon rubber cap, with most of the electronics located in the bottom of the cap or inside of the stem and in one variant, the user interfaces are visible externally (for the images and sensor readings to he transmitted to a video system such as phone, camera, television, computer and so forth, or transmitted to a health care center via Internet and a server). All of the electronics and user interfaces are placed within the hermetically sealed areas of theintravaginal monitoring device511, so as to be able to handle vaginal discharges, and then be able to wash and clean after use.
• FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device ofFIG. 1b.Theintravaginal monitoring device611 contains wired and/orwireless communication interfaces661 as well as firmware and program & operational logic codes693 that makes it possible for theintravaginal monitoring device611 to communicate with the local external electronic devices as well as receive control signals via (immediate) external electronic devices. Moreover, theintravaginal monitoring device611 also containsmemory681,processing circuitry641,displays663 and user input devices665. Thememory681 additionally containsnetwork management module683,display management module685,application programming module687, externalmemory management module689, IMD server module (SM)691, sensor data695 and workspace697.
• Firmware and program &operational logic codes683 allow theintravaginal monitoring device611 to perform in accordance with specific logic that includes: (a) Receiving and/or executing instructions, in case of wearableintravaginal monitoring device611, as to when to switch on and off functionality on the device, when and at what points in time to take images/video clips/sensor data, and at what interval they should be taken; (b) Receiving and/or executing instructions to vibrate/beep, and then, switch off and transfer data to an external device or external servers (such as after enough data to make diagnosis has been taken and it is lime to switch off until some other time or in emergency situations such as sometime before delivery of a baby); (c) Receiving and/or executing instructions that involves exceeding limits in cases of sensor data; and/or (d) Monitoring the battery operations and informing the user to recharge batteries, if need be; and so forth.
• The sensors and devices that are incorporated into theintravaginal monitoring device611 include components of one or more of: (a) UV and IR emitter anddetectors621, to monitor temperature; (b) Piezo microphones andspeakers623, to monitor heartbeat sounds of fetus, for instance; (c) Electrolyte andEKG interfaces625, to take electrocardiogram graphs of heartbeat of a fetus, for instance; (d)Pressure transducers629, to make pressure measurements within the intravaginal channel, to monitor dilations, for instance; (e)Thermal contact assembly631, to take temperature measurements in cases of wearableintravaginal monitoring device611, for instance; (f)Glucose sensor633, to take glucose measurements; (g)PH sensor635; and/or (h)Sonogram head unit639.
• In all of the above-mentioned sensor cases, aprocessing circuitry641 executes, as mentioned above, the operational logics, and takes measurements at appropriate intervals and also verifies if the limits arc exceeded and precautionary actions should be taken. Other components of theintravaginal monitoring device611 depicted include normal (infrared and ultraviolet)illuminators667, fixed-manual-auto focus lensing669, a bunch of photodetector arrays673,675 (or one or more arrays positioned at predetermined locations on the device) and fixed-manual-auto focus microscopic lensing679. The wired and wirelesscommunication interface circuitry661 also contains: (a) Display interface649, to support on screen displays on external monitors, for instance (on a smart phone or other mobile communications device, e.g. two way); (b) External memory interfaces643, to interface with external computers and deliver the memory contents; (c)Network interface645; and/or (d)Application programming interface647, alone or in combination.
• FIG. 7 is a schematicdiagram illustrating data755 flow betweenintravaginal monitoring device719 and various systems ordevices711,713,715,717,721 within the supporting network infrastructure. Within the supporting infrastructure, there are various entities such as the711,713,715,717,721, all of which in a centralized or distributed form hold sensor data (sensor information/query information) from a plurality ofintravaginal monitoring devices719.
• In addition, the data/information755 also contains data generated via queries, as remedies to various reproductive health related issues or as data collected from auxiliary devices (such as blood pressure, heart rate, blood chemistry, physiological parameter inputs), R&D systems/devices inputs713, user IMD support systems/devices717, practitioner's supporting systems/devices715, pharmaceutical computing systems/devices721 and central supporting systems711 (or in another variant distributed computing systems including but not limited to cloud networks).
• Each of these entities is responsible for dissemination of information/data755 and they flow with permission from therespective entities711,713,715,717,721,719 in an encrypted form. These data or information flow in turn assist R&D systems/devices inputs713 develop new medicines, user IMD support systems/devices717 to take care of the data and avail user forum suggestions and recommendations, practitioner's supporting systems/devices715 to provide treatments to the users ofIMD719, pharmaceutical computing systems/devices721 to develop or recommend medicines and central supportingsystems711 to possibly govern and control all of the movements of data and information in a secured manner.
• FIG. 8 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's data view page. The snapshot of the user's data view page of the reproductivehealth management system811 depicts data view page of the current registered user. Additionally, all of the available user's pages include records, queries, electronic mail, forum, research, accounts, IMD setup, support, educational, tutorial and shopping, among others (depicted in theFIGS. 9 through 17). All these user's pages assist in making the intravaginal monitoring device functional in very specific ways that are designed to assist follow up of routine reproductive health care or a specific reproductive health care related condition.
• The snapshot depicts, in all four major windows. The right side window, named as “Time Position Status”, shows various sensor boxes as applicable to the current device. Hence, the Time Position Status window are consist of temperature, viscosity, acidity-PH, electrolytes, heart rate, fetal rate, dilation, cervical face, vaginal channel, user symptoms and so forth (along with a notes text box). Any of the selected sensor data/information is pictured in the left side graphical window (which are show live sensor data or select group of sensor data in a time lapse sequence) and/or image window (which are show live video or select group of images in a time lapse sequence). These windows appear on a smart phone display in one variant, in full or condensed format, and or on various tabs or pages that are open on the smart phone.
• A chronological time line chart bar/marker (shown as a dashed straight line in the graphical window) shows the data/information about the selected sensors at the Time Position Status window. The corresponding image or video clip is shown on the top-left window. Shown on the top of this image window is the time limit, that is, begin and end times as well as the current position. This current position is selected by using a marker at the bottom graphical window (chart bar/marker shows exact time line and allows user to drag left or right).
• Moreover, the snapshot also shows a tool box, containing various tool icons, that includes magnify, mark, select, notes for the current image and general notes, mail, database storage and so forth. A small tool bar at the top of these icons is associated with the video and image displays and allows the user to playback, start, stop, pause, fast forward, fast reverse the displayed video images.
• Additionally, all of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that are enabled by clicking on the “Tools” icon. The client's browser825 (which can be the user, third party or the health care professional, for instance) also shows a status bar indicating current IMD status813 and on line status815. Options are also provide to annotated sensor data and images with note data, medical report data, future follow up data and the like.
• For instance, the current data points of the graphical window, shown in dashed lines are for normal female data, e.g. normal within medical ranges, along with the current user data. Similarly, the tool bar allows zoom in or out a select area, cut and mark a select area to show gynecological or obstetrics notes add notes to them, and then, store those images in the database and mail them if necessary (the user are write a small note such as “Is this normal?” and send the current image via email). A small button or icon or tab on the right side of the graph allows the graphical window to be collapsed.
• FIG. 9 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's record page. Thissimple records page911 contains listing of all of the various types of available intravaginal monitoring devices (such as LUM-F106, LUM-G13A) as well as other work records of the current user (such as query: user or query: doctor). All these records are listed in the current record page. Again, these web pages appear on a standard PC or laptop in one variant, or in another variant appear on a smart phone screen, alone or in combination with the same views or views created or adjusted for presentation on the appropriate remote device, e.g. PC or smart phone
• The record page also is provided with many buttons (displayed at the bottom) that allows the user to view, search, delete, select all or clear selections. Each of these displayed records contains date, duration (if applicable, as in the case of video clippings), description and a select check box fields. These fields assist the user in remembering the contents as appropriate and to select a relevant record for detailed viewing (shown inFIGS. 10aand10b).
• To view any of the records, the user are click on the select box on the left side of the record and then click on the view button, which takes the user to the next pages depicted inFIGS. 10aand10b.Additionally, all of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon such as927. The client'sbrowser925 also shows a status bar indicating current IMD status913.
• FIG. 10ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's queries page. The queries page provides all the data records listed in rows, each containing the fields of select, category, subcategory, last (sensor readings), due (date of sensor readings), and estimate (sensor reading take time). The query pages permit a user of health care professional to augment data from the intravaginal monitoring device, with other data relevant to a diagnosis or tracking of a female medical event or condition, and provide for more facts upon which a diagnosis or tracking of a condition of an event can be made by the user or medical professional. The device and method herein are used to create or augment an electronic medical record for a user which can be stored on the device, on a smart phone communicatively linked to the device, or at a remote database to which this electronic medical record data is sent.
• These fields allow the user to select a particular record (such as an ovulation electronic medical record data) and then communicate the data to whichever server/systems that the user intends to send queries to. The major categories are predefined such as ovulation, coitus, impregnation, 1^st, 2^nd, 3^rdtrimester, postpartum, STD-detect, cervix-artifact, measurement, background and so forth, in one variant of the invention. Similarly, a subcategory is also predefined, to assist the user to quickly determine the query to be sent, for instance, to a health care professional. The last date of the sensor reading taken and due date of sensor readings to be taken are also preprogrammed, with the help of a health care professional for instance, to further assist the user.
• At the bottom of the queries page, buttons are provided to initiate a query, view last query, delete, select all and clear selection. These buttons allow the user to further the proceedings from the listing toward reading and communicating with the relevant health care professional, a user forum, R&D of a medical device manufacturer computer system, or pharmaceutical manufacturer computer system, or pharmaceutical personnel.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1025 also shows a status bar indicating current IMD status1013.
• FIG. 10bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's queries page. Thisquery page1051 allows the client (which can be anyone who has the access to these queries, including the user, users of a forum, health care professional, R&D and pharmaceutical personnel) to read query messages and reply to them (in the next mail window of theFIG. 11), if necessary. Query pages include entry pages regarding a history of sexual activity, the name of the patient, insurance information, week of pregnancy information, consulting physician information, primary health care provider information, HMO information, social security number information, national health care information, method of payment information, credit card information, family member information, insured information, type of insurance policy information, number of pregnancy information, date of last menstruation information, allergy information, allergy to drug information, previous abortion information, number of children information, the ability for the patient to take a photo icon and include it in the electronic medical record profile, electronic medical record information, the ability to download electronic medical record information from a remote source connected to the Internet, information about a woman's moods or feelings, information about the tenderness of a woman's breasts, information about the sensitivity of a woman's nipples, bloating information, history of sec partner information, name of sex partner information, marital status, history of sexually transmitted disease information, history of therapy information, current drug intake information, history of anal sex information, number of sex partner information, history of previous gynecological or obstetrics events or conditions, history of endometriosis information, and an relevant information that would assist a physician to make a diagnosis, and or provide a treatment for a condition or event. The query page answers are stored on a smart phone described herein, on a memory of said intravaginal device, on a remote data base communicatively linked to these devices, alone or in combination. The query information as well as information harvested by the intravaginal device, e.g. all or select portions thereof, are selectively, on any one of these devices and databases, alone or in combination.
• The listing in this page has the columns of select, category, by (sent by), usage, Q# (query number), description and Q-Triggers (that is, in response to which query). The client can read these short messages on the window at the bottom along with any attached notes. At the top of the page, many links are also available that assist the user in searching, sorting and also quickly find the messages. These links include predefined queries, query builder, reports, database, chart and display.
• The query page also provides buttons at the bottom that includes view, add, search, delete, edit, initiate and hide detail. Among other actions (similar to those in the query page of theFIG. 10a), the buttons also allow the user to initiate a new query via the next mail page ofFIG. 11.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1055 also shows a status bar indicating current IMD status1053.
• FIG. 11 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's mail page. The client's mail page is a typical mail page that contains an inbox, and categories of sent, draft, trash, compose, select all, clear all and search. These assist in performing any of the mentioned tasks that includes searching through the inbox or other groupings.
• The mail page contains the columns of select, from: category (such as gynecologist, obstetrician, pharmaceutical, R&D and so forth), from (the name of the sender), regarding (subject of the communication sent), date, views, query, other.
• The user views any of the massages by selecting them and the bottom window displays the corresponding message. These massages are general, sent for instance by a gynecologist or obstetrician to all of the patients or are be specific, sent only to the client. The message window also shows attachments, if there are any (such as an image of a healthy reproductive parts to a patient who would like to know whether a particular condition is normal or not). These attachments also include word processed documents, electronic digital photos (e.g. historically taken images by the intravaginal device), appointment requests, meeting requests, virtual house call requests, confirmation of virtual house calls, electronic prescriptions for a therapy or a drug, reports, appointments for follow up tests, etc. The intravaginal device, and or smart phone then processes real time or near real time data with historical data, e.g. images, and displays the images, e.g. or other sensor data, side by side on a display of the smart phone or PC. The algorithms described herein can perform a comparison and highlight discrepancies or changes in the images and sensor data automatically in one variant of the invention.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1125 also shows a status bar indicating current IMD status1107.
• FIG. 12ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's forum page. Theforum page1205 of the user or client is meant for the clients (which includes users of the IMD) to read the contents of the postings by other users as well post one's own messages (and read responses for those postings).
• The forum page is designed on the basis of categories such as news, obstetrics, gynecology, support, IMDs, shopping, account, artificial insemination technician news, search (and logout, once the reading and/or posting is accomplished). Each of these categories come with their own subcategories such as general discussions, family planning, abortions, the physcological effects of abortions, adoption options, miscarriage, first, second, third trimester, sonogram and complications. These postings are arranged in rows, each row containing the above mentioned subcategories, while the columns are arranged by contents such as obstetrics (a main category) and posts (that is, number of posts) and recent posts (most recent relevant posts that might be of interest to the user; displayed with subject head, date/time of posting). Clicking on one of the subcategory entry such as general discussions takes the user to a next page depicted in theFIG. 12b.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1225 also shows a status bar indicating current IMD status1207.
• FIG. 12bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's forum page. The depiction shows a page that the user arrived into, by clicking the general discussions subcategory inFIG. 12aand the current page provides facilities to search, go back to forum home page or logout.
• The general discussion entries are arranged in rows, each row having columns such as title (or, subject head), latest reply (are in response be to the user's own postings previously), by (those who responded), replies (number of replies), views (number of people who viewed the corresponding posting).
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1255 also shows a status bar indicating current IMD status1253.
• FIG. 13 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's research page.
• Theresearch page1305 of the client is reserved for the clients to read the contents of latest research postings by research establishments. This is of particular interest to those users who are undergoing treatments for a certain condition, for which new research and developments by various institutions and organizations (that includes medical schools, for instance) have been going on. Hence, the user is able to get all these research and developmental information in one convenient place. This information is optionally displayed on the smart phone screen in one or more pages permitting the user or medical professional to truly be informed about the best and most innovative options of therapy for a given event or condition, long prior to coming to the doctor for consultation. It is appreciated the device and system described herein creates a truly well informed and knowledgeable female about her own body and the events and conditions that are affecting it, including infectious diseases in obstetrics and gynecology.
• The research page contains categories such as professional publications, peer reviewed journals news, obstetrics publications, gynecology publications, pharma publications, IMD data, accounts functionality, account functionality, search functionality (and logout, once the reading and/or posting are accomplished). Each of these categories come with their own subcategories such as a published medical database data and information, rapid research notes, obstetrics today, pregnancy magazines, mothering magazines, STD related magazines, and newsletters (e.g. published magazine), British medical journal (are be published magazine), webmd.com (are be an on line publication organization), ACOG, RSOG, AMA and so forth. These postings are arranged in columns, each column is arranged by contents such as obstetrics (a main category) and overview (that is, brief explanation of the subcategory). Clicking on one of the subcategory entry such as general discussions takes the user to a next page containing detailed entries from the same institutions or organizations. This information is displayed on a PC related device or on a smart phone in an appropriate format.
• It is appreciated that the intravaginal device sends data to a remote node on the network regarding the female's particular condition or event. This data is then used to select the appropriate return information feed so that only relevant information and or website links for the female is transmitted back to the smart phone or laptop to educate the female or the medical professional as to the condition. Similarly, in another variant, where the user of the methods and system described herein is a medical professional, information or web site links regarding current treatment protocols, drug therapies, complication information for the condition or event are sent to from a node on the network and provided to the medical professionals smart phone or PC for display thereon. It is appreciated that the medical professional and the female has access to state of the art drug therapies, new treatment technologies, treatment protocols approved by professional organizations, IVF procedures, costs and the like.
• All of the available user's pages, such as the medical records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled and or disabled by clicking on the “Tools” icon. The client'sbrowser1325 also shows a status bar indicating current IMD status1309.
• FIG. 14ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's account page. The user accountspage1405 maintains user's personal information, some of which are be made available to health care professionals (in case of treatments for a condition is sought) and other login information to various user forums, R&D pages, shopping, mail and VOIP phone facilities. These web pages are presented on a smart phone, PC, workstation to appropriate users, e.g. a female, a sex partner, a medical professional, an obstetrician, a gynecologist, a hospital administrator, an insurance company employee or consultant, a researcher, an engineer, a medical device company individual, etc. The web pages permit a female or other party described to manage the woman's gynecological and or obstetrics health throughout her lifetime, e.g. from early years of life through end of life.
• The user information itself, e.g. as input on a query page (e.g. on a smart phone or PC) contain name (first, middle, last), address, city, state/country, zip codes or postal codes, phone numbers and email addresses, e.g. including the female patient, the doctor, the midwife, the hospital admissions staff, a nurse, an insurance company. This information, with user permission, is be made available to other entities (such as health care professional nodes, R&D establishment nodes, pharmaceutical company nodes, insurance provider nodes, National Health Care System nodes on the network described herein and so forth; described with reference to theFIG. 7). In addition, user information and data also include login information that assists the user to quickly login without entering user name (handle) and password each time. The login information or data contain a login handle (user name or userID), a password, website (to which the user has subscribed) or which is entered automatically by the smart phone or intravaginal device, and include a select box that lets the reproductive health care management software and node know and interpret whether an auto login mode of functionality is enabled.
• A “Related Medical Information” button allows the user to enter personal medical information (described with reference to theFIG. 14b) that is made available to health care professional nodes, R&D establishment nodes, pharmaceutical company or supplier nodes and so forth, as well. All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1425 also shows a status bar indicating current IMD status1407 and on line status1409.
• FIG. 14bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces of another variant ofFIG. 1b,wherein the snapshot depicts user's account page. The current user accounts page contains same personal information as in the case ofFIG. 14a, such as the name (first, middle, last), address, city, state/country, zip codes, phone numbers and email addresses; and in addition also contains related medical information about the IMD user, identifier data of the specific intravaginal device, e.g. serial number, user profile, etc.
• The related medical information includes but is not limited to, age, height, weight, prior known related conditions, cholesterol, other information, blood group, blood pressure, lower waist line circumference, belly button waist circumference, under breast circumference, breast-chest circumference, week of pregnancy, and so forth, including the other information described herein; any or all of which are gathered from queries (by the health care professionals, for instance) or extracted from a remote medical records archive node on the network described herein.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1457 also shows a status bar indicating current IMD status1453 and on line status1455.
• FIG. 15ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1bin another variant of the system and network, wherein the snapshot depicts user's IMD setup page.IMD setup page1505 can be exhaustive, nonetheless, many of the information are be filled in automatically by auto detect and remotely by health care professionals opting for a follow up of a particular medical condition (by downloading a condition follow up firmware, for instance). The user then onwards simply has to follow up the instructions provided in the data view, records or queries pages. In yet another mode of operation of the invention, the system and network include a mode of operation in which historical female health condition information, e.g. electronic medical records of different medical professionals are harvested from many different nodes on the network where they reside in databases so as to provide a complete profile of the female from the medical records point of view.
• A typical IMD set up page contains columns such as select (to select a particular model and version or firmware), model, version, support site (where additional help and firmware are be available) and description (of the follow up firmware, connection type—wireless or wired, type—wearable or non-wearable and so forth). This information also comes up with auto detect, add and delete buttons and modes of operation to take appropriate actions.
• Once selected or auto detected, the bottom half of the page provides various configurations. As mentioned above, these are also automatically opted by the user or remotely by a support server, based upon the type of usage (such as pregnancy-follow-up, for instance). The depiction shows the configuration information for a particular model such as LUM-F106 and IMD status (inserted), battery levels, memory available, wireless reception (in this case of tethered wiring, it is N/A—not available). It is appreciated that the system, methods and network of the present invention provide for an automatic set up mode for the user, e.g. on the smart phone or PC, that is a function of the condition or event the female is currently being treated for or experiencing.
• Other configuration modes include operational modes, video camera mode, temperature mode, wearable duration and indications (along with buttons that assist in settings, update, visit support, order kits, manual and test the device). The settings button or icon takes the user to a next IMD setup page.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1525 also shows a status bar indicating current IMD status1507 and on line status1509.
• FIG. 15bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b, wherein the snapshot depicts user's IMD setup page. The current (depicted) page allows various specific configuration modes to be set up (based upon the selection made in the IMD set up page ofFIG. 15a, LUM-F106, for instance). The preset modes (on the right window of the page) allow the user (or remotely, by professionals) various settings as follows: (a) General Health—a routine checkup mode set by the user, without expecting any assistance by external servers or professionals, for instance; (b) Cancer Detect/Monitor mode—that allows the auto enabling many particular sensors on the left side of the window, in conjunction with health care professional's assistances—that are include routine images taken by the Main camera, IR camera, UV camera, Microscope and temperature sensors, drug dispenser (a compartment within the IMD that delivers drugs to the correct area—e.g., cervix—or delivery over time when worn), for instance, and moreover, enabling Dye Douche Kits—assisting detection of cancer; (c) STD Detect/Monitor—an under “Light Treatment”, including certain blue frequencies that are used to minimize bacterial/fungal growth—it should be noted here that such blue frequency is a common acne treatment today; all UV causes DNA/RNA damage to both the virus/bacteria/fungus and the patient so low doses and correct UV is used herein; it also noted that this can be used to reduce the amount of normal female yeast; some female have excessive amounts and yeast infections commonly (also, enabling Dye Douche Kits—assisting detection of fluids, bacteria, fungus, etc.); (d) Fertility Cycling; (e) Conception Avoidance—are necessitate monitoring and certain treatments or fluid delivery and PH Douche—Environment Promoting Gender+Ovulation Sync via Douche Kit; (f) Pregnancy Promotion—are necessitate monitoring and certain seminal fluid delivery—to promote impregnation using “cap” containment with automatic or manual alerts (audible, vibrating, LEDs, phone call, phone/pc display indications to user to use a syringe attachment, rubber ball squeeze injection, etc.); (g) Pregnancy Follow-up—an enabled microphone, that allows measurement of mother's heart rate, fetal heart rate, fetal activity detection on trimester basis, so forth. It is appreciated that the system and mode of operation provides for an intravaginal device that can be used to treat undesirable vaginal flora and infections, e.g. yeast infections and the like, as well as track the progress of the disease, inflammatory state of the female organs, and the like.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1557 also shows a status bar indicating current IMD status1553 and on line status1555.
• FIG. 16 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts user's support page. The user'ssupport page1605 is intended to provide the user assistance in searching for a gynecologist, obstetrician, other doctors (such as fertility specialists) and find retailers (who sell products other than the ones provided by reproductive health management). In this variant of the invention, it is appreciated that the system, e.g. the smart phone or PC, node in the network automatically provides the female with data, e.g. name, appointment calendar, location, of a medical professional that can address the medical needs of the female. A registry of medical professionals is provided on a database node of the communications network. The system selects appropriate specialists in the vicinity of the user, e.g. through GPS functionality (within a certain designated radius of the female's location), communicates this data over the communication pathways, and displays their information and data to the user on the smart phone, and their availability for an appointment. This reduces the stress on the user and the need to wait to obtain a therapy or treatment for the condition they have of the event they are experiencing. This reduces the amount of physcological suffering and physical suffering the female user experiences by reducing the time from an indication that there is an abnormal condition to the time that actual treatment or therapy is administered.
• Thesupport page1605 contains several main links (all of which are meant to provide assistances to the user) such as referral, IMD (provide IMD related support, for instance), site (provide reproductive health management site related support, for instance), PC-software (such as latest firmware), phone-PDA software (that is, firmware for supporting phones or PDAs), clinical(s) (provide assistances with latest clinical stages research and developments), organizations and logout. The smart phone and or intravaginal device also has a mode of operation that communicatively links (with appropriate access authorization and security functionality) to a medical records archive node on the network to transmit appropriate data from the intravaginal device or smart phone directly. The electronic medical records node on the network, in another variant, is a medical records archive node that stores electronic medical records data from a multiplicity of female users located in remote locations globally. The archive receives and processes several terabytes of data from remote nodes on the network, e.g. including by way of example, millions of intravaginal devices communicating with smart phones and PCs, alone or in combination, in the communication network described herein.
• Each of these main links provides their own categories to help in getting assistance in a quickly and in a very efficient manner, automatically without or with very little human intervention. For instance, the referrals main link, as depicted, contains several categories such as find an obstetrician, gynecologist, local retailer, on line retailer and so forth (along with overview or descriptions for each of the category). Each main link has a sublink, provided automatically or selected manually by a user of sub-specialists or other medical professionals.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1625 also shows a status bar indicating current IMD status1607.
• FIG. 17 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts a user's shopping page. The user'sshopping page1705 is designed to provide the user assistance in shopping for IMDs, software applications, pharmaceuticals and so forth. The shopping pages or tabs are provided on a smart phone node on the network, a PC node on the network, a laptop node on the network, and other nodes on the network described herein. For example, a link to the Pampers™ web site is provided, a link to a vendor is provided, an advertisement, is provided. Advertising data flows from a Pampers™ advertising data server over the communication pathways of the communication network for display in a pop up on a user's smart phone, in response to the Pampers™ server receiving data identifying the user as being an soon to be mother. The advertisement is sent at an appropriate time to secure a sale of Pampers™ diapers.
• Theshopping page1705 contains main links (all of which are meant to provide quick and easy shopping interfaces to the user) such as referral, IMD (provide IMD related shopping), site (provide reproductive health management site related shopping, for instance), PC-software, phone-PDA software (for example, shopping firmware and software for the IMD supporting phones or PDAs), clinical(s), support organizations and logout. It is appreciated that other nodes on the network provide for billing, shipping and payment functionality, e.g. credit or debit card functionality, as well as a node on the network providing functionality to obtain a percentage of each sale of product or service as well as referral fees for professional services, returning to a commercial enterprise node on the network, e.g. including but not limited to a medical device manufacturer node on the network.
• Each of these main links come with their own categories, tabs, sub-tabs, that makes shopping an easy experience, such as, IMD, software applications, pharmaceuticals, homeopathy and baby products (along with overview or descriptions for each of the category) under referral. Included on the smart phone is a mode of functionality that permits the selection of applications both for the smart phone and also for the intravaginal device. These applications are paid for by the user and or insurance carrier and or by a national health care system automatically or via payment screens and functionality on the smart phone node of the network. By way of further example, applications include a pregnancy monitoring application, a premature birth monitoring application, an ovulation monitoring application, a fertility monitoring application, an STD detection application, a birthing application, a post birth monitoring application, a precancerous cell detection application, a cervical cancer monitoring application, an infection detection application, a rhythm method application, a birth control application, a therapy monitoring application, a cervical health monitoring application, a vaginal health monitoring application, a genital warts monitoring application, and an HPV monitoring application.
• All of the available user's pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client'sbrowser1725 also shows a status bar indicating current IMD status1707.
• FIG. 18ais a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b, wherein the snapshot depicts health care professional'spatients page1805. The health care professional'spatients page1805 contains a list of patients (all of whom are associated with one of several models/versions of the IMDs that are available for shopping and with a concerned gynecologist, obstetrician or any other specialist), each of the patients having associated with certain codes and relative importance in terms of seeking medical care/advice. It is appreciated that the smart phone node also serves to manage a medical professionals time by automatically alerting a medical professional as to the medical condition of a patient under his or her care. In another variant, the patient data sent to the medical professionals smart phone node is queued as a function of the immediacy of the need of the medical professionals intervention, e.g. several pregnant patients are ranked by the system on a node of the network, and the women who are at the point of giving birth or needing an epidural or other therapy or treatment are presented first to the medical professional smart phone node of the network on a tab, e.g. which can flash different colors, e.g. red, yellow, and green, according to their immediacy of the need of the intervention. This functionality permits the medical professional or clinic or birthing center with an accurate way to provide efficient and timely medical services.
• The list of patients in this health care professional'spatients page1805 is arranged in rows, with each column containing a list of patient's names, ID# (identity number of the patient), due, time (due date and time for any of the IMD related procedures, such as taking sensor readings at one instant or for a prolonged period), regarding and code. The regarding column are be reminder notes to the doctor such as a first visit-general or routine examination, annual checkup, repeat: fertility treatment, monthly checkup and so forth.
• The health care professional'spatients page1805 also comes with a select column and many buttons such as view, search, delete, select all, clear selection (all of which have similar functions as that of the user'srecords page911 of theFIG. 9). For instance, when the health care professional selects a patient and click on the view button, the page ofFIG. 18bappears (which provides an overview and billing aspects with regards to the selected patient). In another variant, these pages permit searching of archived medical records and images, and comparison of archived data with current day data harvested from the intravaginal device. This permits ready tracking of disease conditions, therapies and the like, as well as an electronic medical record of the state of the female's sex organs over the course of her life.
• The specialist or sub-specialist (or any health care professional, if unable to remember the patient) can see a photograph or video of the patient by clicking on a face icon1827 (which pops up an image or small video—of a first visit, for instance). The entire available health care professional's patients pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 18athrough19) also contain tool boxes that can be enabled by clicking on a “Tools” icon. The health care professional'sbrowser1825 also shows a status bar indicating current IMD status1807. Similarly, there appears on the page a photo of the woman taken at different points in her life, allowing the medical professional to associate the data for the female with her current electronic medical record information, some or all of which was harvested by the intravaginal monitoring device. The same digital photo of the woman appears on the medical professional's smart phone node on the network.
• FIG. 18bis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts health care professional's patient'saccounts overview page1851. The depiction shows another of the health care professional'spatients page1851, which is also a patient's records page. Similar to the conventional files of a patient that contains several personal and medical details as pertaining to the selected patient, the current depicted page and that of theFIG. 18calso contain many of the personal overview, medical and billing details as pertaining to the patient. Similarly, the medical professional smart phone network nodes provides the physician billing and commercial information about specific users so that he or she can manage his or her business aspects of the practice of medicine.
• The patient personal information/overview contain patient ID, name (first, middle, last), address, city, state/country, zip codes or postal code, phone numbers, age, email addresses, mobile phone numbers, electronic medical record information, and a photo or small video. In addition, a button or icon for emailing, smsing or contacting the patient and another button for VOIP or direct phone call is also available. It is appreciated that another node on the network (including appropriate links, icons and tabs) includes a Skype™ node on the network, an instant messaging node on the network, a Facebook™ node on the network, a Google™ node on the network, a National Health Care system node, an insurance company node on the network, an HMO node on the network, a PPO node on the network, a hospital node on the network, a physicians practice group node on the network, a Twitter™ node on the network, an emergency first responder node on the network, a social networking node on the network, a drug company node on the network, a medical device company node on the network, and a birth control vendor node on the network to facilitate communication between users of various nodes on the network, and other data transmission modes of operation. The health care professional's patients page1855 also comes with many buttons such as view, search, delete, select all, clear selection. For instance, when the health care professional clicks on the view button, the page ofFIG. 18cappears (which provides a billing aspects with regards to the patient, among other information).
• Also, at this time of attending to the patient, a timer (or, a time counter) also goes on in one variant, indicating how much time the doctor/health care specialist has spent on the patient. This information is used to bill for the doctors time, and produce an invoice to the patient, National Health Care system, private insurance carrier, etc. (described further with reference to theFIG. 18c). Reimbursement code data is also correlated with other data and electronic medical records and other data harvested from the intravaginal monitoring device and transmitted therefrom to other nodes on the network. The current health care professional's patient'saccounts overview page1851 also provides a brief medical summary of the patient's medical history along with a provision to annotate the medical records or information harvested from the intravaginal device, and write further notes base upon the current status of the patient, derived from the new IMD data.
• The health care professional's patients pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 18athrough19) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The health care professional'sbrowser1851 also shows a status bar indicating current IMD status1853.
• FIG. 18cis a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts health care professional's patient's records view andinvoicing page1871. The health care professional arrives at the current health care professional's patient's records view andinvoicing page1871 by clicking on the view button in the page ofFIG. 18b. Here, the health care professional is allowed to select on the type of the interaction, professional advise, medical diagnosis, therapy performed with reference to the current patient (whose name, user ID and phone numbers appear on the top of the page; and if unable to remember the patient, the health care professional is allowed to see a digital photograph or video clip of the patient by clicking on a face icon on the bottom-right of the page). In another variant, a digital record of an examination of the female is also archived and correlated with the patients other electronic medical records, including data harvested by the intravaginal device.
• The selections for the health care professional (in the current health care professional's patient's records view and invoicing page1871) include type of the interaction, date and time, duration (based upon the timer) and description (based upon the notes left by the specialist, for instance). The depiction shows the IMD LUM-F106 being selected and the description includes video image and temperature data collection (upon which the health care specialist deliberated, analyzed, reported on, and wishes to produce an invoice).
• The bottom of the page contains the type of billing (such as based upon hourly rate, flat fee, reimbursement code or fixed rate), timer duration, invoice description and notes and annotations. The entire available health care professional's patients pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 18athrough19) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The health care professional'sbrowser1875 also shows a status bar indicating current IMD status1873. It is appreciated that with the smart phone network node the medical professional has global access to patient data and can work from anywhere in the world in real time given the patient data access. For example, a physician can be at a medical conference in Hawaii while simultaneously reviewing in real time patient medical records, and providing analysis, feedback and even making phone consultations with patients and other medical professionals. By way of further example, medical consultation with world thought leaders can be obtained using the network nodes of system described herein. For example, a world thought leading specialist in premature birthing located in Switzerland can be consulted by a doctor in Russia regarding a patient with an untypical condition or rare condition. The Swiss expert can review on his smart phone network node and or his or her PC, in real time the patient data and provide a consultation.
• FIG. 19 is a schematic diagram illustrating a snapshot of one of the reproductive health care management web pages or system interfaces ofFIG. 1b,wherein the snapshot depicts health care professional's patient'sbilling page1905. The health care professional's patient'sbilling page1905 is exclusively reserved for billing aspects of the current patient and specialist, based upon the interactions that have taken place so far.
• Hence, the health care professional's patient'sbilling page1905 contains a listing of bills produced (with reference to the current patient and specialist) and service records. The list of columns includes service, (service) date, invoiced (date), invoice # and notes. The bottom half of the page contains the type of current billing (such as based upon hourly rate or fixed rate), timer duration, invoice description and notes.
• Again, the entire available health care professional's patients pages, such as the electronic medical records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in theFIGS. 18athrough19) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The health care professional'sbrowser1925 also shows a status bar indicating current IMD status1907. During billing or any other times, if the health care specialist is unable to remember the patient, the health care professional is allowed to see a photograph or video of the patient by clicking on a face icon on the bottom-right of the page.
• FIG. 20 is a perspective diagram illustrating an exemplary support architecture configuration for servicing a female reproductive system, wherein the service involves use of real-time analysis engine functionality in accordance with various aspects of the present invention. Therein, anIMD2017, a wearable IMD, has been inserted via avaginal channel2015 into a femalereproductive system2005. TheIMD2017 has a plurality of sensors disposed therein, including, for example, an axial optical imager, a radial optical imager, a pair of imagers, a temperature sensor, a microphone, a glucose sensor, an EKG sensor, etc.
• While inserted and operating to capture sensor data during an insertion session, theIMD2017 maintains wireless communication one or more various supporting devices, such as alaptop computer2045,support systems2093, and asmart phone2041. TheIMD2017 may maintain such communication either directly in a point to point fashion or via anaccess point2043 and acommunication network2091. Some of such communication can also be maintained with some of the supporting devices via others of the supporting devices.
• The supporting devices illustrated may be located at the same premises as that of the femalereproductive system2005 or located at an entirely different location. Either way, the real time sensor data from theIMD2017 is delivered so as to support a real-time display (based on such sensor data) in a visual working environment on each of the supporting devices. In addition, analysis engine operations (within one or more of the various illustrated elements of the support architecture) also receive such sensor data such that output from the analysis engine can also be displayed in virtually real time along with the representations of the sensor data within such visual working environments. Additional input into the analysis engine operations can be received from the various supporting devices, the IMD or third party sources (not shown). Such input may even involve (i) sensor data or test data from other types of supportingmedical systems2097, and (ii) generalmedical information2095,2051,2071. All input is either automatically or manually (via patient, medical staff, or third party input) delivered into the analysis engine.
• Based on the input, various intermediate and final conclusions regarding a particular status of thereproductive system2005 can generated by analysis engine operations and output for visual display and storage, or to other systems such as the supportingmedical systems2097,2053,2073 (or another medical device local to the reproductive system2005) for their own further processing. Control signals and alerts based on such conclusions may also be generated. For example, control signals might be delivered to a supportingmedical system2097 or to theIMD2015 to adjust one or more characteristics or operations thereof. They may also comprise requests for further capture.
• As mentioned, the overall analysis engine functionality can be placed on one or more of the devices as illustrated by the gynecologicalanalysis engine blocks2099,2075,2055. Note also that theblocks2051,2053,2055,2057 are merely representative of counterparts that may be found within thelaptop computer2045, theIMD2017, thesmart phone2041 and perhaps an additional type of IMD or other type ofmedical device2021.
• FIG. 21 is a schematic and perspective block diagram illustrating another possible support architecture employing gynecological analysis engine operations that may reside in one or more of a plurality of supporting devices and systems such as diagnostic equipment located at a health care facility. Therein, an intravaginal monitoring device (not shown) may be inserted within a vaginal channel within the health care facility or be located remote therefrom. Either way, the intravaginal monitoring device is in communication via thecommunication network2191 with the various supporting architecture shown.
• As with the particular support architecture ofFIG. 20, generalmedical information2195,2113,2131, supportingmedical systems2197,2115,2133, andanalysis engine operations2199,2117,2135 can be found within any one or more of the elements of thepresent support architecture2105. Such elements include acommunication network2191, anaccess point2111,cell phones2123,2151,laptops2121,2153 and even within supporting diagnostic equipment illustrated within ablock2157.
• Within such a support infrastructure vast pluralities of IMDs and associated other patient medical devices can be supported, even when the patient has no supporting computing devices of their own. In another variant, the communication network and the functionalities described herein reside in cloud computing network nodes. Within the visual working environments of a medical staff'ssystem2125 or a doctor'ssystems2155, a patient can be selected from a plurality of patients under care can be made. Such selection changes the visual working environment to one directed at the selected patient's reproductive system by accessing (i) previously retrieved sensor information, related data and notes, and (ii) generated analysis output based thereon. If currently active, the sources of sensor data and real time analysis engine output can be fielded to provide a virtually real time visual working environment for review, evaluation and analysis. Similarly, the virtual real time visual working environment permits a medical professional to monitor and address the needs of several patient's simultaneously, no matter where the patient's are located. By way of example, a screen can contain windows related to a plurality of patients, and by subsequent links provide an entire electronic medical record profile of the patient, and the group, accessible by the user with the simple click of a mouse.
• FIG. 22 is a schematic block diagram illustrating analysis engine operations within an intravaginal monitoring device (IMD), built in accordance with various aspects of the present invention. More specifically, IMDs can be built without any analysis engine functionality. They may merely deliver raw sensor data (which includes optical imager sensor data) with or without measurement pre-processing performed thereon or related thereto. They may also only perform a selection of the overall analysis engine operations found in a support architecture, or may perform all such operations. The IMD illustrated does perform at least part of the overall analysis engine functionality.
• Within the illustrated IMD, the firmware and program &operational logic codes2265 allow the intravaginal monitoring device to perform in accordance with specific logic, in one variant, that includes: (a) receiving and/or executing instructions, in case of wearable intravaginal monitoring device, as to when to switch on and off, when to take images/video clips/sensor data, and at what interval they should be taken; (b) receiving and/or executing instructions to vibrate/beep, and then, switch off and transfer data to an external device or external servers (such as after enough data to make diagnosis has been taken and it is time to switch off until some other time or in emergency situations such as sometime before delivery of a baby); (c) receiving and/or executing instructions that involves exceeding limits in cases of sensor data; (d) monitoring the battery operations and informing the user to recharge batteries, if need be; and so forth.
• In fact, the illustrated IMD may operate in one of a plurality of modes based on: (i) input via a user input device of the user input devices and displays2255 and (ii) control signals originating outside of the IMD from a supporting device. For example, in a wearable mode of operation, the device can be worn by the user continuously, but its functionality is turned on or off at different times during the wearing session per mode settings to save battery power and conform to session measurement goals. Similarly, a mode can specify when specific functionality within the IMD becomes active or in an idle state, when communications should be sent and to which supporting systems, the type of analysis operations to perform (if any) and when, etc.
• In addition to one or a plurality of optical imager sensors, other sensors and components that may be incorporated into the IMD may include components of one or more of: (a) IR emitter anddetectors2221 used perhaps to monitor temperature or blood flow; (b)piezo microphones2223, to monitor heartbeat sounds of a female and/or her fetus, for instance; (c)EKG contacts2225, to take electrocardiogram graphs of heartbeat of a fetus, for instance; (d)piezo speaker2227, to produce a soothing sound for the fetus, for instance; (e)pressure transducers2229, to make pressure measurements within the intravaginal channel, to monitor dilations, for instance; (f)thermal contact assembly2231, to take temperature measurements in cases of wearable intravaginal monitoring device, for instance; (g)glucose sensor2233, to take glucose measurements; (h)pH sensor2235; (i)electrolyte sensor2237; (j) fetal brain activity monitors; and/or a (k)Sonogram head unit2239.
• In all of the above-mentioned sensor cases, aprocessing circuitry2261 executes, as mentioned above, the operational logics, and gathers sensor data and performs pre-processing to extract consumable, measurement information based thereon. From the raw sensor data, the related measurement information produced, historical counterparts thereof stored within amemory2273, and any of a plurality of types of other sensor data or information (medical information, historical data, human input, etc.) received via the communication interfaces from supporting devices outside thereof, operations, theprocessing circuitry2261 performs various analysis engine operations pursuant toanalysis engine instructions2269 retrieved from thememory2273. All of the analysis engine operations mentioned through out this application with reference to various figures herein, or a subset thereof, can be performed.
• Other components of the IMD depicted include displays2255, user interface devices and displays2255, normal (infrared and ultraviolet)illuminators2251, fixed-manual-auto focus lensing2247, a plurality of photodetector arrays (i.e., imager arrays)2245,2243, fixed-manual-auto focus microscopic lensing2241, and lens zoom capability (mechanical and or digital).
• The analysis engine2255 functions as an automatic servicing entity, that is to provide service to the clients as well as the healthcare professionals in assisting to come to a conclusion on the bases of the measured and quantized parameters that emerge from the intravaginal monitoring device, not only at the present time, not only based upon the historical data emerged from that intravaginal monitoring device but also based upon the data emerged from a plurality of intravaginal monitoring devices.
• Lastly, as constructed, the illustrated IMD may operate in an entirely self contained mode, or under control of one or more external supporting devices. In the later case, all or part of the functionality defined within theanalysis engine instructions2269 can be turned on or off or replaced or supplemented by such supporting device or devices. In other words, like other controllable modes of operation, the illustrated IMD can be placed in an independent and various controlled modes of operation. Such placement can be via the user input devices and displays2255 or via external control signals originating from such support device(s).
• FIG. 23 is a schematic block diagram illustrating components of one embodiment of an analysis engine that may be found in whole or in part within one or more of the various devices and systems of a network supporting intravaginal monitoring, wherein the analysis engine illustrates various aspects of the present invention. That is, the various blocks of the analysis engine can correspond to software instructions and/or dedicated hardware depending on the design of the particular device in which such blocks are found. They and other components of theanalysis engine2311 may be found in whole or in part, for example, on a supporting server, further medical systems and computers, a patient's supporting computing device, a medical staff member's computing device, etc.
• In particular, processing circuitry2321 pursuant to the operational logic2323 (firmware or software) carries out various analysis engine operations based on a variety of input data such as: a) a user's or patients input data2341; b) doctor's or medical staff data23343; c)data2345,2347 from external supporting medical device of a user or a doctor; d) diagnosis and treatment information, conclusions anddata2349; e)IMD sensor data2351,2353 from a current and prior sensor data gathering session; f)medical information data2355; g) analysis logic data2357 (which can be modified via external control signals as can the operational logic2323). With such data which may be interactively gathered via automated requests or through automatic direction via control signals and preprocessing.
• Theoperational logic2323 and theanalysis logic data2357 together define the various operations of theanalysis engine2311, including how and when to abate one to all operations, for example, in response to control or direction originating outside of theanalysis engine2311. The term “outside” as used above may still be within the particular device in which theanalysis engine2311 resides, or may be outside of such device entirely and within a different supporting device or IMD.
• FIG. 24 is a schematic block diagram illustrating an analysis engine such as that ofFIG. 23, placed at least in part within a server to illustrate server based analysis engine functionality along with other server operations related thereto, the server and underlying functionality built in accordance with various aspects of the present invention. Therein, a supportingserver2411 containsanalysis engine operations2455 and other supportingoperations2421.Such operations2411,2455 are carried out pursuant to application software tailored for support operations and hardware typically found in a conventional servers.
• Within theanalysis engine operations2455 all or a portion of the analysis engine operations mentioned within this specification, for example, may be included. For example, analysis ofsensor data2437 and related various types of supporting data and information2429 (some retrieved from adata storage2453 and other received via the communication processing functionality2441) can be utilized to produce either intermediate or final status conclusions about a plurality of reproductive systems serviced by the supportingserver2411 via, at least in part, a corresponding plurality of IMDs.
• The supportingoperations2421 include: a)registration management2423,account management2423; b) directed advertising2427 (based on revealed characteristics of a particular female being serviced); c) alert and other conclusion processing2431; d) third party (non patient and non medical staff) interaction support2433 (e.g., pharmaceutical or research organizations); e) doctor andpatient interaction support2435,2433; f) thecommunication processing2441; and g) presentation management associated with the various visual working embodiments found in the corresponding various supporting computing devices within the overall support network. Regarding the latter, the supportingserver2411, using typical web servering or “app” serving approach, may deliver conclusion information, gather further information from patients, doctors and third parties or their computing systems, and otherwise at least assist in creating tailored visual working environments for a patient's supporting computer, a doctor's computer or phone, etc.
• As before, although the entirety of possible analysis engine operations are illustrated within the supportingserver2411, they can be distributed in whole or in part throughout the various other possible network components. To support the many configurations of support architectures, IMD capabilities and supporting system capabilities, theanalysis engine operations2455 use of particular analysis operations can be selected to best conform to such configurations. In other words, for a first patient with a relatively simplistic IMD design and no supporting devices beyond theserver2411, only those analysis operations that apply to such IMD are performed by theserver2411. Yet in another embodiment with a relatively advanced IMD and a plurality of other supporting systems, a more full set of analysis options becomes available for use by the supporting server. Even so, less that the “more full set” might be employed if such other supporting devices or such more advanced IMD is designated to carry out all or a portion of such analysis operation “set.”
• FIG. 25 is a schematic block diagram illustrating another embodiment of analysis engine integration within a network supporting intravaginal monitoring, and build in accordance with and illustrative of various aspects of the present invention. Therein, within thenetwork infrastructure2505,central support servers2591 service various supporting operations to support a plurality of IMDs of differing levels of functionality (some of which relates to analysis engine operations). Each of the plurality of IMDs being used by a corresponding plurality of females via intravaginal insertion into their reproductive system.
• Regional and remotehealth care servers2551,2539 and remote health care servers also provide support to each other, thecentral support servers2591 and, of course, to the plurality of IMDs. Such support is provided via wired/wireless, point-to-point, Internet/Intranet network pathways2513,2511. The support server1289, in conjunction with the regional and remote health care professional servers1259,1239, enables many of the herein mentioned functionalities including the analysis engine operations and support for presenting visual working environments for various supporting computer systems.
• In particular, at the remote server(s)2539, perhaps located within a doctor's office, local supporting medical information2521 can be retrieved in an automatic, automated or manual fashions (depending on the underlying infrastructure) from supportingmedical systems2529, and can be used along with other generalmedical information2527 as input to ananalysis engine function2531. Other input for the analysis engine function,2531 includes for exampleIMD sensor information2525 and medical personnel data (extracted via the interface2523). Therefrom, all, none or portions of the overall analysis engine functionality can be performed.
• Similarly, corresponding infrastructure supporting analysis engine operations within the regional andcentral servers2551 and2591 can be found. Overall, it can be appreciated that theservers2591,2551,2539 together contain a vast amount of analysis engine operations and data. Such data can be exchanged there between as needed such that the servers can each carry out their designated and available analysis engine operations. Designation may involve not only the selection of which server will handle a particular operation, but also includes whether a non-server supporting device (not shown) or IMD (not shown) will have such responsibility.
• FIG. 26 is a cross-sectional diagram illustrating one of many possible variations in dimensions, contour, and orientations, i.e., form factors, of acap2609 andoptics assembly2613 of anIMD2605 sized to correspond to various “form factors” of intravaginal and cervical regions. Therein, theIMD2605 is inserted via a mostly axial direction of avaginal channel2601. Within thevaginal channel2601 at a mostly radial angle therein, acervical region2603 is illustrated. The insertion of theIMD2605 proceeds until thecap2609 falls within an area near thecervical region2603.
• The insertion process may benefit from visual guidance of the process via the display of live imager data on an associated display (not shown), and wherein the live imager data is captured by the mostly axially orientedimager2611. When reaching the illustrated position, thecervical region2603 falls within a field of view of a mostlyradial imager assembly2607. The mostlyradial imager assembly2607 can thus be used to provide further imager data for a more detailed evaluation of various aspects of thecervical region2603.
• That is, theimager assembly2611 captures only a portion of the cervical area, but such capture can be used: a) to assist in the guidance process by allowing the user to find and target thecervical region2603 for image and video capture by theimager assembly2611; b) along with the image and video capture from theimager assembly2607 to construct a panorama, 3D information, etc.; c) to support analysis and viewing of other artifacts, events or conditions outside of thecervical region2603 but within thevaginal channel2601; and d) to support pre-processing measurements of thecervical region2603 such as the height, length, width, etc., of the cervix or associated cervical opening portions of the cervical area—an important indication during pregnancy.
• Theoptics assembly2613 of theIMD2605 is inserted within amain housing stem2614. Theoptics assembly2613 supports theimager assemblies2611,2607. Thecap2609 may be made with a firm but compressible material (such as silicone rubber) that permits installation, removal and replacement. This may be accomplished by feeding the optics assembly into the inner chamber of thecap2609. Radial tension of the opening portion of thecap2609 due to elasticity of thecap2609 supports at least a partial hermetic seal and mechanical constraint.
• As illustrated, the field of view and underling mounting angle of theradial imager assembly2607 is adequately matched to the illustrated reproductive system's orientation and size. Exemplary fine tuning adjustment, however, might involve one or more of: a) installation of a different sized and shaped optics cap; b) relocating theradial imager assembly2607 to provide better field of view coverage of the present cervix; c) changing the angle of theradial imager assembly2607 to provide view more normal to the surface of plane of thecervical region2603; d) extending or retracting theaxial imager assembly2611 directly (or relatively via use of a longer cap) to (i) minimize having theradial imager assembly2607 within the field of view of theaxial imager assembly2611, (ii) minimize having theaxial imager assembly2611 within the field of view of theradial imager assembly2607, and (iii) attempting a better lateral image of thecervical region2603 by relocating theaxial imager assembly2611.
• Moreover, further imager assemblies (not shown) could be added to the optical imager assembly, or one of theimager assemblies2607 or2611 can be removed. An imager assembly may have integrated illumination lighting and lensing, or other optical elements supporting an imager array installed therein.
• The illustrated cap is termed an asymmetric cap as it does not maintain symmetry in the radial direction. Of course fully symmetric caps can be used, such as that illustrated inFIG. 1. Similarly, to maximize the target coverage area for a field ofview2615 of theimager assembly2607, theimager assembly2607 is oriented off center and in the opposite radial direction from that of the cervical region2603 (the intended target). Similarly, theimager assembly2607 having a field ofview2607 is positioned with a significant distance to the end of thecap2615. With such positioning, it is more likely that a reasonably large target coverage area for capturing imager data (by the imager assembly261) can be maintained. In addition, the extended axial length of thecap2615 can help in positioning theimager assembly2607 in its mostly axial position that orients fairly well with the opposing orientation and axial location of thecervical region2603. If for example, a female's cervical region is much smaller than that illustrated and located closer to the entrance to the vaginal channel, thecap2609 might be replaced with a longer counterpart. If the cervical region of another female is located in a normal orientation as viewed from the axial direction, a centrally located axial imager assembly only might be used with a symmetric cap of perhaps narrower dimensions.
• If installation of a replacement for thecap2609 is insufficient to address a mismatch between the optical assembly and the desired target, e.g., the cervical region2603 (which varies greatly from female to female), theoptics assembly2613 might be swapped with another via an electrical and mechanical mating engagement, e.g., a connector within thestem2614 which matingly engages with a counterpart connector on the base of theoptics assembly2613.
• However, note that although larger optics assemblies and caps may be optimal, they may give rise to more difficult and uncomfortable insertion of an IMD. Thus, where these “fitting” processes are limited by comfort and insertion concerns, other cap and optics assembly selections may still prove useful as a compromise under the given reproductive system.
• Other aspects of the present invention can be found in additional functionality relating to all of the above embodiments such as that set forth as follows.
• The mobile phone may also consist of a graphic reflecting an event or condition associated with a female's reproductive health. The graphic may be associated or related to: (1) an event or condition associated with a family's fertility, female's reproductive health; (2) female's strength of her vaginal muscles; (3) female's pregnancy, detection of an infection; (4) detection of a sexually transmitted disease condition or event; (5) detection of a precancerous cervical condition; (6) detection of a human papilloma virus detection; (7) detection related of a cervical injuries; and/or (8) detection of an abortion.
• Moreover, the mobile phone may contain a query related to: (1) a sexual history of a female; (2) a medical history of a female; (3) a miscarriage; (4) the number of previous pregnancies of a female; (5) the date of last menstruation; (6) the number of previous cesarean section procedures; and/or (7) the number of previous births. The above-mentioned query itself may be input by a female onto the mobile phone query.
• The query may also consist of those related to an ovulation monitoring; and there may also be a graphic related to the ovulation cycle. The mobile phone, in addition, may consist of a calendar; the calendar indicating a peak fertility period of time, and non fertile period of time.
• The aforementioned mobile phone may also include a mode of operation that consists of an automated rhythm method providing electronic information to a female regarding her fertility cycle, and in which data from the intravaginal device is used as an input into the mode of operation. The mode of operation may include displaying data related to a determination of a pregnancy.
• The mobile phone's display may also have modes of operations that depict: (1) a photo of a doctor; (2) a photo of a female; (3) parameters related to prenatal monitoring; (4) parameters related to a female; (5) parameters related to a fetus and a female; (6) a labor prediction display; (7) a premature birth parameter display; (8) a false labor display; (9) a true labor indicator; and (10) illustrating contraction timing.
• Additional measurements, display and illustrations done by the aforementioned mobile phone include: (1) a cervical dilation measurement; (2) illustrating fluid flow; (3) illustrating position of a cervix (position of the cervix is selected from the group consisting of a central position, an anterior position, and a posterior position, for example); (4) an advertising (selected from the group consisting of a diaper advertisement, a baby food advertisement, a baby furniture advertisement, a baby clothing advertisement, an advertisement related to a product for a newborn, an advertisement related to a product for a mother, an advertisement related to a product for a father, an advertisement related to a nutritional supplement for a newborn, an advertisement related to medical services, an advertisement related to insurance coverage, and an advertisement related to services related to a premature baby); (5) indicating the condition of the tonus of a female (the firmness or softness of muscles surrounding a female's womb); (6) a time line related to the release of waters pre-birth; (7) parameters related to a fetus in a womb (related to the position of body parts of a being in a womb of a female); (8) a condition of a female's cervix; (9) a post birth healing monitoring mode of operation; (10) a menopause onset detection mode of operation; and (11) graphics for an in-vitro fertilization mode of operation.
• A process for providing in vitro fertilization using the intravaginal monitoring device and a mobile phone is provided. It consists of: (1) displaying on a mobile phone a calendar or chart indicating peak fertility days to a female, and providing said female an in vitro fertilization therapy, in combination and monitoring fertility drug performance. The therapy itself consists of a drug therapy (such as a fertility medication that is injected, a fertility medication that is taken orally, a fertility medication that is taken by nasal spray, and a fertility injection, for example). The mobile phone mode of operations for coordinating administration of a fertility therapy with a female's menstrual cycle, the mobile phone having a mode of operation from receiving data from an intravaginal monitoring device. The mobile phone itself may consist of a photo of a sex partner, a photo of a doctor, a photo of family member's, and a photo or graphic depicting a cervix or measurement associated the said cervix. The aforementioned mobile phone mode of operation also presents the information on the display of the screen so that a user can determine infertile days.
• In one embodiment, a system for getting pregnant, consisting of a mobile phone having a fertility calendar, and an intravaginal device for monitoring fertility events, is provided; such that the device communicates with the mobile phone. In conjunction with the system, a method for getting pregnant and a kit for getting pregnant are provided, consisting of a mobile phone and intravaginal device system to determine peak fertility days, and taking a fertility drug therapy. The aforementioned method and kit may include: (1) having multi-orgasmic sex; (2) providing drug therapy selected from the group consisting of a progesterone therapy, a gonadotropin therapy (for example, the gonadotropin therapy is a recombinant gonadotropin therapy), alone or in combination with other fertility drugs; (3) the drug therapy is selected from the group consisting of a GnRH Agonist therapy, a Lupron Depot® therapy, and a drug therapy administered on different calendar schedules depending on the female; (4) the drug therapy is selected from the group consisting of a gonadotropin-releasing Hormone antagonist therapy, a drug therapy preventing the release of LH and or FSH, a clomiphene citrate therapy, a Clomid® therapy, a drug therapy to stimulate ovulation, a Clomid® therapy, a Serophene® therapy, and a Milophene® therapy, and a human Menopausal Gonadotropin (hMG) therapy.
• The mobile phone may have communicated thereto a sonogram image data of a being in a womb of a female in data storage of the mobile phone, and a mode of operation for presenting data associated with a pregnancy. The mobile phone may consist of a communication link with an intravaginal monitoring device.
• A system for tracking events during a pregnancy and birthing process are also considered in one of the embodiments, consisting of a mobile phone network node (having an application to receive data from an intravaginal monitoring device, an external electronic monitor sized and dimensioned to be worn on a pregnant female's stomach network node, the monitor consisting of a communication link to the mobile phone). The mobile phone network node also has a graphic user interface consisting: (1) a graphic depicting cervical opening size; (2) a mode of operation for automatic birthing alerts to an expectant father; (3) a mode of operation for displaying the expected weight of the being in the womb, the weight being calculated based upon a weight determination (such as a predetermined statistical weight data file, and a weight determined by sonogram dimensions of the being in the womb); (4) an expectant parent information about an expected birth of a child (such as location information regarding an expectant mother, location information regarding a birthing center, location information regarding a medical professional responsible for a birth, location information regarding an expectant father, location information regarding an emergency treatment center, location information regarding an institution having facilities to manage a high risk birth, location information for the fastest route to a location for giving birth, location information regarding family or friends of an expectant mother, and location information of a medical clinic).
• The mode of operation of the mobile phone node includes, alone or in combination: (1) a display for prediction of the time of active labor; (2) a display that distinguishes between active labor and passive labor, and provides an indicator (such as an audible indicator, a preprogrammed voice indicator, a visual indicator, and audio visual indicator, and a vibrational indicator) of same to a user; (3) storing a plurality of data communicated from an intravaginal monitoring device to the mobile phone; (4) storing a plurality of data communicated from an intravaginal monitoring device to the mobile phone; so forth. Analysis of sensor data sufficient to provide any of the displays listed above is preformed on any of the network nodes described herein.
• In one embodiment, the mobile phone's applications (for processing data received from an intravaginal monitoring device) include: (1) a mode of operation for obtaining wired data from the intravaginal monitoring device; (2) a mode of operation for obtained data wirelessly from the intravaginal monitoring device; (3) a mode of operation for transmitting said data from the mobile phone to a remote device wireless communicating to the remote device (such as a server communicatively linked to the Internet, a server communicatively linked to an intranet, an electronic device forming part of a wide area network, an electronic device forming part of a metropolitan area network, an electronic device forming part of a local area network). The mobile phone's applications may also consist of a mode of operation for communicating data received from an intravaginal monitoring device, and optionally an external monitoring device having sensors thereon for monitoring physiological parameters of an expectant mother and or being in a womb.
• Instead of the mobile phone node, an independent electronic, wireless device and network having the features, functionality and modes of operation of the disclosures herein are also considered. Similarly, an electronic, wired device and network having the features, functionality and modes of operation of the disclosures herein are also considered. Mobile phones consisting of: (1) applications for receiving and post processing data received from a wireless intravaginal device sensing physiological parameters related to the health of a female; (2) applications for receiving and post processing data received from a wireless intravaginal device sensing physiological parameters related to a being in a womb; (3) smart phone functionality and a post processing mode of operation for receiving and processing data from an intravaginal monitoring device; and so forth are also considered.
• Similarly, an external data communication device (for example, incorporated into an item of apparel) consisting of a mode of operation for processing data harvested by an intravaginal monitoring device, in which said processing comprising providing displays regarding parameters related to a female's reproductive health is also provided.
• A network consisting of a mobile phone (for example, a smart phone with an operating system), and an intravaginal monitoring device communicatively linked to the smart phone is also provided. The smart phone supports email, the emails related to: (1) the female reproductive health data; (2) female and medical professional communications.
• In another embodiment, a smart phone, further consists of a mobile communications device, communicatively linked to the aforementioned smart phone; the mobile communications device includes another smart phone, a smart phone with an application to provide a medical professional with data about a patient, a smart phone with an application to provide an expectant father with information about a pregnant female, a smart phone with an application to provide an expectant mother with information about a child within her womb, and a smart phone with an application to provide to provide insurance or national health care insurance information to a provider of medical services, is considered in one another embodiment.
• The smart phone network consists of an intravaginal monitoring device and the smart phone in one embodiment. The smart phone consists of an application that includes a personal organizer, advertising data, a female user interface (including a miniature QWERTY keyboard, a touch screen, an I-Pad application, a built-in camera, a contact management, an accelerometer, built-in navigation hardware and software, the ability to read document data, media software for playing music, browsing photos and viewing video clips, Internet browsers).
• An intravaginal monitoring device sized and dimensioned to provide data from with a vagina, comprising an accelerometer is also provided. A network consists of an intravaginal monitoring device and a mobile communication device communicatively linked to the intravaginal monitoring device, the monitoring device consisting of an accelerometer, or optionally the mobile communication device consisting of an accelerometer is also provided.
• A network consisting of an intravaginal monitoring device and mobile communications device, and a secure communication link between the monitoring device and the mobile communications device is also provided, in one of the embodiments. Further, the aforementioned network may further consist of a secure communication link between the mobile communications device and a device communicatively linked to the Internet.
• A network consisting of an intravaginal monitoring device and a mobile communications device, and a data archive comprising image data from a plurality of females of internal female organs is also provided in one of the embodiments.
• In another embodiment, a network comprising an intravaginal monitoring device sized and dimensioned to fit inside a vagina and a web site on the Internet accessible by a female to view data harvested by said intravaginal monitoring device is considered. The network may further consist of a smart phone (such as a BlackBerry™ brand phone) that includes an application for processing data harvested by said intravaginal monitoring device. In the aforementioned network, the smart phone may also include a contact list (that includes data of an obstetrics or gynecology medical professional). The contact list data may also include data of a sex partner of a female, data of a family member of a female, data of a birthing center, data of a clinic, data of a clinic to treat a female infertility problem, data of treatment center for a sexually transmitted disease, data of a medical professional, data of a medical professional treatment group, and data of a medical diagnostic center.
• A network, consisting of an intravaginal monitoring device with a built in memory for storing physiological data, and a mobile communication device with a built in memory (the monitoring device having a mode of operation for sending data from the memory of the monitoring device to the memory of the mobile communication device) is considered in one of the embodiments. A network consisting of a plurality of Nokia™ smart phones, each the smart phone communicatively linked with an individual intravaginal monitoring device is also provided.
• A network consisting of a plurality of smart phones each of the smart phones consisting of a smart phone camera for taking pictures, the smart phone camera having a focal length suitable for taking pictures at least 3 meters to infinity, and a plurality of intravaginal monitoring devices communicatively linked to an individual smart phone, each of the intravaginal monitoring devices capable of harvesting a digital image with a camera having a focal capable capturing an image from 0.1 cm to 10 cm from the camera is also provided, in one of the embodiments. The aforementioned camera may be a digital CMOS camera, for example; consisting of an array. The smart phone itself may consist of hardware and software permitting Wi-Fi and or Wi-Max data communication. An intravaginal monitoring device consisting of hardware and software permitting wireless web browsing is also provided. A network consisting of an intravaginal monitoring device and a smart phone communicating therewith, said smart phone capable of wireless web browsing is also provided.
• A network is provided consisting of an intravaginal monitoring device, a mobile communications device, the mobile communications device, and optionally the intravaginal monitoring device consisting of an operating system is also provided. The aforementioned operating system may include Windows CE Pocket PC OS, and a Palm OS.
• A network consisting of an intravaginal monitoring device, the device communicatively linked to a mobile communications device, the mobile communications device consisting of an open source platform is also provided. A network consisting of a device sized and dimensioned to fit into a vagina, and be wearable, and a mobile communications device consisting of an Android™ operating system is also provided. A network consisting of a device sized and dimensioned to fit into a vagina, and be wearable, and a mobile communications device consisting of a HTC smart phone is also provided. A network consisting of a device sized and dimensioned to fit into a vagina, and be wearable, and a mobile communications device consisting of a mode of operation for navigating web pages is also provided.
• A network consisting of a device sized and dimensioned to fit into a vagina, and that is wearable and self powered, and a mobile communications device consisting of a software suite is also provided. The software suite may consist of Google™ applications such as a map application, calendar application, a Gmail™ application, a Google Chrome Lite full HTML web browser, and a third party application. The software suite may consist of a paid for application downloadable from an Apple™ applications node located on the Internet. The software suite may also be a smart phone application delivered directly to the mobile communications device, such as an iPhone™ and an iPod™, and in which said software suite is delivered to said mobile communications device directly over a cellular network, a Wi-Fi network, or a Wi-Max network, alone or in combination. The software suite may include a Symbian operating system, an iPhone operating system, a RIM operating system, a BlackBerry operating system, a Windows Mobile operating system, a Linux operating system, a Palm Web operating system, an Android operating system, an Android and or Web operating system built on top of Linux, and an iPhone operating system derived from an BSD operating system and or a NeXTSTEP operating systems, alone or in combination.
• A communications network consisting of a node consisting of a self powered, intravaginal monitoring device, and a GPS receiver located remotely from said intravaginal monitoring device, the device and the GPS receiver consisting of a mode of operation for communicating with one another, is also provided in one of the embodiments. The GPS receiver may consist of a mode of operation for providing the geographical location of the intravaginal monitoring device. The communications network may further consist of a node on the network for communication of data of the geographical location to a location processing node on the network. The geographical location data is may include a location of an expectant mother, a location of an expectant father, a location of a medical professional, a location of a clinic to treat a female health condition and or event, a location of a hospital, a location of a nearest health care provider, a location of a midwife, and a location of a in vitro fertility center.
• A self powered device, consisting of an intravaginal monitor for monitoring conditions of a female and/or being within a womb of the female, and a GPS receiver, is also provided in one of the embodiments. The communications network or intravaginal monitoring device of any of the disclosures herein, in which the aforementioned receiver that is tuned to multiple channels, is also provided. The communications network or intravaginal monitoring device of any of the disclosures herein, in which said receiver relays position data to a receiving node on a communications network is also provided.
• The communications network or intravaginal monitoring device of any of the claims herein, further consisting of a navigation mode of operation. The navigation mode of operation includes a navigation mode to direct a pregnant female to a birthing center, a navigation mode of operation to guide a female to female health condition or event crisis management center, a navigation mode of operation to guide an expectant father to an expectant mother, a navigation mode of operation to guide an expectant mother to a medical professional, a navigation mode of operation to guide a female to a clinic, a navigation mode of operation to guide a plurality of people who have been involved in the procreation process to a single location for a birth, a navigation mode of operation to guide a medical professional to a female, a navigation mode of operation to guide a first responder to a female in need of medical attention related to a female condition or medical event, and a navigation mode of operation.
• A mobile communications device for two way communications via a cellular or Internet network, consisting of a display having an alert generated from data harvested from an intravaginal monitoring device, whereby the intravaginal monitoring device is communicatively linked to the mobile communications device is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display having graphic or text generated from data harvested from an intravaginal monitoring device, the data consisting of heart rate data is also provided in one of the embodiments. The heart rate data may include an expectant mother's heart rate, and a being the womb's heart rate. The aforementioned mobile communications device further consists of identification data consisting of a name of a female, data of a week of pregnancy, data on the number of pregnancies of a female, data of the last menstruation of a female, data of a medical professional, data representative of a sonogram of a being within a womb.
• A mobile communications device for two way communications via a cellular or Internet network, consisting of a display having data representative of a cervix is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display showing cervical dilation is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display having a numerical indication of cervical dilation is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display showing a date and time, and cervical dilation at said data and time is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display showing cervical dilation over time is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display having showing data harvested from an intravaginal monitoring device is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a display having an alert generated from data harvested from an intravaginal monitoring device, whereby the intravaginal monitoring device is communicatively linked to said mobile communications device is also provided in one of the embodiments. A mobile communications device for two way communications via a cellular or Internet network, consisting of a graphic user interface for an expectant father illustrating data on an expectant mother, and optionally data on a child in said expectant mother's womb is also provided in one of the embodiments.
• In one embodiment, a method is used by a server in a communication network, e.g. communication network. The communication network has a plurality of sensor devices and a support computer. Within such a network, it is appreciated that the management of a group of pregnant females in a birthing center, and outside of a birthing center pregnant females is facilitated using the method, and the communication pathways provided for by the method. For example, Hospital A's birthing center admits pregnant female patient's B-Z. Patient's B-Z are utilizing the device and methods of the invention prior to admission so that clinically relevant data on each patient is provided while each of the pregnant females B-Z, are at home, work, at the birthing center, or any location remote from the birthing center.
• These patient's mobile phones are provided instructions so as to properly time their admission depending on how advanced their labor cycle is, and otherwise proceed under Doctor's orders. The appropriate nurse midwife or physician is provided with a visual working environment through their work stations with real time or substantially real time information of which patient will next go into active labor (vs. being in passive labor), and delivery. The medical professional's time and hospital beds and other resources, including monitors, are then brought to where they are needed, just in time. If simultaneous pregnant females go into active labor, then additional resources can be organized in advance and obtained in a timely manner without stretching existing resources, e.g. doctors and nurses, to thin or creating a life threatening situation for the pregnant females or their unborn babies because of lack of qualified staff or specialists.
• Within the birthing center, the visual working environment displays, for example, include information related to the sensed data, in whole or in part, on pregnant females B-F. Clinically, pregnant female B is in passive labor, has a window with her image data, relevant medical information data, location data, image of her cervix data (including all relevant clinical parameters), contraction information data, breaking of the waters status data, information sensed related to her fetus data, etc. in the same window (or other screen). Clinically, pregnant female C is in active labor. A window with Female C's image data, room number data, cervical diameter (greater than 6 cm) data, effacement information data, temperature data, next of kin contact information data, and fetal information data appear in the visual work environment. The nurse midwife's work station or smart phone issues an alert regarding pregnant female patient C. The alert notifies Nurse Mid Wife Z's, and she focuses resources on pregnant female C, as she is about to deliver.
• By way of further example, pregnant female D is 26 weeks pregnant, is at risk for a premature birth event, and is being monitored remotely by nurse midwifeZ utilizing device105. Nurse midwife Z notices several disturbing trends concerning pregnant female D on a window reflecting data relating to pregnant female C. Graphs and other visual interfaces of cervical depth data taken over the last three hours indicates that pregnant female D's cervix has been thinning, that her cervical OS has gone from 0.5 cm to 2.5 cm, and that other clinically relevant parameters indicate that she is at high risk of a premature birthing event imminently. Nurse midwife Z is presented with an alert in her visual working environment.
• As a result of the alert, the method causes Nurse midwife Z's phone to ring with a pre-recorded voice message alert. The pre-recorded message alert results in an automated call to pregnant female D on her mobile phone and sends an sms to her and to her Doctor, Doctor D, and instructs pregnant female D that the system has sent an alert to dispatched an ambulance to pregnant female D's location for her so that she can be admitted to the birthing center immediately.
• Pregnant female D's location data was provided to the ambulance operator via his mobile phone on his visual working environment display using the GPS functionality of pregnant female D's mobile phone and/or the intravaginal monitoring device and system. An alert was provided to pregnant female D's husband support device over the communication network when he was at work, providing a pre-recorded message requesting that he call his wife regarding the pregnancy. This happens, and the husband and wife immediately discuss the status of the pregnancy.
• D's husband tracks his wife's physical location in the ambulance using GPS functionality on his phone (via a specific application) in his visual working environment which is communicatively linked to the server and the intravaginal monitoring device and/or wife's cell phone's GPS functionality, and follows the ambulance to the hospital to be there for his wife. The ambulance brings pregnant female D to the birthing center within 15 minutes of Nurse Midwife Z's alert and call.
• At the birthing center, Doctor D determines, that since pregnant female D arrived to the birthing center in a quickly, and before her condition deteriorated further, she is a candidate for a therapy. He performs the therapy, which involves placement of a cervical prosthesis, bed rest, and other therapies. The therapy is successful and pregnant female D gives birth to a healthy newborn son at 38 weeks of gestation. The combination of the method of diagnosis utilizing the communication network of the present invention, and therapy results in a successful outcome.
• By way of further example, pregnant female E is 37 weeks pregnant during her first pregnancy, and being home monitored with anintravaginal monitoring device105. Clinically, pregnant female E feels periodic contractions. She feverishly calls her husband and has her husband leave his job as a school bus driver, and drives home immediately believing she is going into labor. She calls the birthing center from her mobile phone by pressing a preprogrammed number in her mobile phone application, and requests to speak with her Doctor, Doctor E, now. Doctor E is not at the birthing center since he has taken a long overdue vacation with his wife in Hawaii.
• At home, pregnant female E and her husband are panicking since they are scared and unsure what to do since this is their first baby. Pregnant female E actuates theintravaginal monitoring device105 and inserts it into her vaginal canal.Device105 harvests sensor data and communicates it via the communication network to a support device. The support device analyzes the sensor data to determine if one or more clinically relevant threshold parameters are met. If yes, an appropriate alert is generated, and communicated and routed over the communication network to nodes on the network.
• The method also generates a patient profile, e.g. using one or more applications. Nurse Mid Wife Z reviews pregnant female E's profile on her visual working environment in real time and while in real time the network shares the profile with Doctor E who views it on his iPad on the golf course in Hawaii. The visual working environment display generated using applications running on one or more nodes in the network indicates that pregnant female E is having periodic contractions, that she does not evidence cervical effacement, and that her cervical OS graph does not show any change over time and is at 0.5 cm, and that fetal parameters are all normal. No alerts are activated for network distribution since the sensed data, and or combination thereof, has not reached relevant thresholds. A conclusion is made by the application software that no hospital admission alert is necessary, and that it is likely that pregnant female E is only having Brixton-Hicks contractions and that no hospital admission is required, and communicates, and properly addresses this information for routing to Nurse Mid Wife Z and Doctor E respective support devices. Nurse Mid Wife Z consults with Doctor E, and Doctor E, and optionally humanly confirms that pregnant female E is having Brixton-Hicks contractions, that she is not in active labor, and that no hospital admission is required. Doctor E, presses a button on his wirelessly connected iPad accessing an application related to the intravaginal monitoring device specific to patient E, and or data files related to patient E created from data harvested by the monitoring device, performs a confirmatory human review of the data, and then calls patient E, and instructs pregnant patient E that she should stay at home, and not proceed to the hospital for admission at this time, as she is not in active labor. Pregnant female E follows Doctor E's orders, and takes some bed rest and the Brixton-Hicks contractions pass.
• Two weeks later, pregnant patient E has another set of periodic contractions which are being remotely monitored by theintravaginal device105 with its sensors. The sensor data is communicated and properly routed via the communication pathways described herein. The sensor data indicates that pregnant female E is entering normal labor, and an alert is issued via the communication pathway to the Mid Wife's and Doctor's supporting devices. At this time Nurse Midwife Z, notices the alert and reviews pregnant patient E's profile remotely and confirms that the sensed profile parameters indicate that pregnant patient E is going into normal labor as the alert indicated, and instructs her to come to the birthing center for admission. Pregnant patient E's husband is alerted that is the “real deal” via an alert communicated to his supporting device via the communication network and communication pathway, and that the baby will arrive in the range of 2 to 6 hours based upon trend analysis of the sensed data. He rushes home from work, drives his wife to the hospital, where she is admitted, goes into normal labor and delivery, and delivers a healthy baby girl. Doctor E was alerted via an alert presented on his smart phone of the impending delivery in advance so he was able to hop out of the shower, review patient E's pregnancy profile data communicated to his support device via the communication pathway and communication network, and delivered the healthy baby girl. It is appreciated that the device and methods of the previous invention reduce stressful, wasteful, unnecessary hospital admissions when they are not need, and provide for timely hospital admissions when they are most needed, saving lives and reducing the incidence of premature birth (with the huge emotional and financial drain associated therewith) when coupled with efficacious, and timely therapies.
• Herein, often referenced throughout the present application, the female reproductive system of humans can be found. Even so, the present invention and various aspects thereof can be found in intravaginal monitoring devices and associated supporting devices and networks designed to service any other species.
• Throughout the present application, various embodiments are used to illustrate some of various aspects of the present invention. It should be clear to one of ordinary skill in the art that yet other embodiments constructed based on elements extracted from several or more of the embodiments specifically described herein are contemplated.
• The terms “circuit” and “circuitry” as used herein are refer to an independent circuit or to a portion of a multi-functional circuit that performs multiple underlying functions. For example, depending on the embodiment, processing circuitry are be implemented as a single chip processor or as a plurality of processing chips. Likewise, a first circuit and a second circuit are be combined in one embodiment into a single circuit or, in another embodiment, operate independently perhaps in separate chips. The term “chip”, as used herein, refers to an integrated circuit. Circuits and circuitry are comprise general or specific purpose hardware, or are comprise such hardware and associated software such as firmware or object code.
• As one of ordinary skill in the art will appreciate, the terms “operably coupled” and “communicatively coupled,” as are be used herein, include direct coupling and indirect coupling via another component, element, circuit, or module where, for indirect coupling, the intervening component, element, circuit, or module does not modify the information of a signal but are adjust its current level, voltage level, and/or power level. As one of ordinary skill in the art will also appreciate, inferred coupling (i.e., where one element is coupled to another element by inference) includes direct and indirect coupling between two elements in the same manner as “operably coupled” and “communicatively coupled.”
• The present invention has also been described above with the aid of method steps illustrating the performance of specified functions and relationships thereof. The boundaries and sequence of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternate boundaries and sequences can be defined so long as the specified functions and relationships are appropriately performed. Any such alternate boundaries or sequences are thus within the scope and spirit of the claimed invention.
• The present invention has been described above with the aid of functional building blocks illustrating the performance of certain significant functions. The boundaries of these functional building blocks have been arbitrarily defined for convenience of description. Alternate boundaries could be defined as long as the certain significant functions are appropriately performed. Similarly, flow diagram blocks are also have been arbitrarily defined herein to illustrate certain significant functionality. To the extent used, the flow diagram block boundaries and sequence could have been defined otherwise and still perform the certain significant functionality. Such alternate definitions of both functional building blocks and flow diagram blocks and sequences are thus within the scope and spirit of the claimed invention.
• One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.
• Moreover, although described in detail for purposes of clarity and understanding by way of the aforementioned embodiments, the present invention is not limited to such embodiments. It will he obvious to one of average skill in the art that various changes and modifications are be practiced within the spirit and scope of the invention, as limited only by the scope of the appended claims.

Claims (20)

1. A support architecture used to service a female reproductive system, the support architecture comprising:

a communication link;

a computing device;

an optical imaging device coupled to the computing device via the communication link;

the optical imaging device, when at least partially inserted within the female reproductive system via a vaginal channel, collects image data relating to at least portion of the female reproductive system; and

the computing device at least assisting in generation of status information, the generation of the status information involving an analysis of the image data collected.

2. The support architecture ofclaim 1, wherein the analysis of the image data collected involves a color analysis.

3. The support architecture ofclaim 1, wherein the image data comprising first image data collected during a first session and second image data collected during a second session, and the analysis of the image data collection comprising a comparison of the first image data with the second image data.

4. The support architecture ofclaim 1, wherein the optical image device comprising an optical imaging first sensor and a second sensor that produces second sensor data.

5. The support architecture ofclaim 4, wherein the generation of the status information also involves the second sensor data.

6. A method associated with a female reproductive system, the method comprising:

retrieving optical imager data related to a target area within the female reproductive system, the target area being accessible via a vaginal channel of the female reproductive system;

performing an automated analysis of the optical imager data; and

producing information based on the analysis, the information at least assisting in identifying a status for at least a portion of the female reproductive system.

7. The method ofclaim 6, wherein the retrieving is performed by a processing circuit within a device that is at least partially inserted within the vaginal channel.

8. The method ofclaim 7, wherein the performance of the automated analysis occurs on a computing system that supports the device via a communication link.

9. The method ofclaim 6, wherein the optical imager data comprises first data captured during a first session and second data captured during a second session, and the automated analysis involves a comparison between the first data and the second data.

10. The method ofclaim 6, wherein the automated analysis involves determinations made based at least in part on measurement data.

11. The method ofclaim 6, further comprising retrieving supplemental sensor data.

12. The method ofclaim 11, wherein the production of the information also involves the supplemental sensor data retrieved.

13. A method used by a computing device that interacts with a monitoring device, the monitoring device having an optical imager that captures imager data from a female reproductive system via a vaginal channel, the method comprising:

receiving a first portion of the imager data, the first portion of the imager data having been captured by the optical imager during a first imaging session;

storing the first portion of the imager data;

receiving a second portion of the imager data, the second portion of the imager data having been captured by the optical imager during a second imaging session;

retrieving the first portion of the imager data from storage;

comparing the first portion of the imager data with the second portion of the imager data; and

producing, based at least in part on the comparison, status information relating to at least a portion of the female reproductive system.

14. The method ofclaim 13, wherein the status information relates to ovulation.

15. The method ofclaim 13, wherein the status information relates to an infection.

16. The method ofclaim 13, wherein the status information relates to a pregnancy.

17. The method ofclaim 13, wherein the status information relates to abnormal cervical cells.

18. The method ofclaim 13, further comprising receiving supplemental sensor data, and wherein the production of the status information is also based on the supplemental sensor data.

19. The method ofclaim 13, wherein the computing device is a supporting device.

20. The method ofclaim 13, wherein the computing device is a server.

Images