INTRAVAGINAL MONITORING SUPPORT ARCHITECTURE

An intravaginal monitoring device supporting network infrastructure, including a smart phone with applications supporting female's healthcare diagnostics. The intravaginal monitoring device communicates via a communication interface to local external devices. The intravaginal monitoring device also communicates with external (central) support servers, smart phones, healthcare professional's supporting systems and devices, research and development systems and devices, pharmaceutical computing systems and devices via wired and/or wireless network pathways. The data flows from the intravaginal monitoring device, to a remote device, e.g. smart phone, and includes image (or sensor) data collected within a memory (e.g. a built-in memory or memory stick) of the intravaginal monitoring device, and then is delivered for inspection, suggestions, annotations, recommendations, discussions and/or treatment, to another device communicatively linked to a cellular network, and Internet, used by a user, one or more healthcare professionals, one or more user forums, research and developmental or pharmaceutical professionals or for secure storage at a remote site. The data is sent in an encrypted form so as to be able to maintain privacy of a female, that is, without the female's (user's) authorization the data cannot be seen or used by anyone within the support network infrastructure in an unauthorized manner.

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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 communicating with said intravaginal monitoring devices, smart phone devices communicating with other nodes on a network, and applications for the smart phones.

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 begins during the teen years and proceed all the way through old age. However, a shortage of healthcare professionals 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 are 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 abovementioned 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 healthcare 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 female 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 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, discoloured discharge, or abnormal discharge). By way of example, STDs are include Gardnerella (greyish, foamy discharge, with a strong fishy smell), Candida (thick creamy whitish discharge, with a yeasty smell), Chlamydia (increased vaginal discharge), Gonorrhoea (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 internaly, 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 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. These female are forced to proceed to the nearest town where a female's healthcare provider are be located. This are involved hours or even days of travel by train or bus further discouraging the female from seeking needed medical care or treatment.

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 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, of the FIG. 1;

FIG. 3 is a schematic block diagram illustrating various sensor placement schemes for intravaginal monitoring devices, of the FIG. 1;

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 the FIG. 1;

FIG. 5 is a schematic diagram illustrating placement of the intravaginal monitoring device of FIG. 1, 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 other built-in electronic sensors, to monitor the well being of a female (and developing fetus in case of the female being pregnant);

FIG. 6 is a schematic diagram illustrating the components of the intravaginal monitoring device of FIG. 1;

FIG. 7 is a schematic diagram illustrating data flow between intravaginal monitoring device and various systems or devices within the supporting network infrastructure;

FIG. 8 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's data view page;

FIG. 9 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's record page;

FIG. 10a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's queries page;

FIG. 10b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's queries page;

FIG. 11 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's mail page;

FIG. 12a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's forum page;

FIG. 12b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's forum page;

FIG. 13 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's research page;

FIG. 14a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's account page;

FIG. 14b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's account page;

FIG. 15a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's IMD setup page;

FIG. 15b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's IMD setup page;

FIG. 16 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's support page;

FIG. 17 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's shopping page;

FIG. 18a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patients page;

FIG. 18b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patient's accounts view page;

FIG. 18c is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patient's records view and invoicing page; and

FIG. 19 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patient's billing page.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic block diagram illustrating an intravaginal monitoring device 101 and its supporting network infrastructure; wherein the intravaginal monitoring device 101 communicates via a communication interface 121 to local external devices 171 and/or external servers 151, 161 via wired and/or wireless network pathways 131. In specific, the depiction shows flow of data between the intravaginal monitoring device 101 and the supporting network infrastructure 171, 151, 161 via communication pathways 133, 135, 137, 139 and/or 141. 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 the intravaginal monitoring device 101 and then deliver them, for inspection, suggestions, annotations, readings, recommendations, discussions and/or as a basis for a treatment or therapy, to the user, healthcare 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 de-encrypted 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, healthcare professionals, and/or user forums only with the 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), healthcare professionals (gynecologist or obstetrician) to receive treatments or for general checkups. The user also wishes to see the images (or, sensor readings) for one's own routine inspections and checkups of reproductive health, possibly in conjunction with healthcare professionals. Exemplary forums used in the invention include Facebook(sm), 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, healthcare 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 healthcare professional's office, consuming valuable time and adding to needless healthcare costs. Using the intravaginal monitoring device 101 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 are herself observe the cervix, 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 healthcare professionals). It is appreciated that early notification of an abnormal condition by the female herself or a healthcare professional leads to early treatment of the event, 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 or 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 healthcare 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 STDs) or at all other periods, or upon periodic request by a healthcare specialist (gynecologist or obstetrician)(the device is remotely activated or placed into a mode of operation), the sensor readings and images obtained via the intravaginal monitoring device 101 are be utilized in taking precautionary actions or advise the female to seek medical professional intervention.

The intravaginal monitoring device 101 can communicate with the supporting infrastructures such as user's IMD (Intravaginal Monitoring Device) client systems 171, supporting server(s) 151 and/or supporting IMD (Intravaginal Monitoring Device) client systems and devices 161 in many different ways: (a) A memory stick intravaginal monitoring device 101 and USB and or mini USB port within the client module (inside the personal computer 177 or mobile phone or smart phone) assist in viewing the data contents on the personal computer 177 and deliver directly to the supporting server(s) 151 and viewed through web pages. To enable this, the intravaginal monitoring device 101 contains a unique network ID; (b) The intravaginal monitoring device 101 are be plugged directly to a television 173 (or communicate with a wireless connection through an intranet wireless network connection or Internet connection) or personal computer 177 display using display management 110 and display driver (all of the software is driven by the display management 110); (c) The intravaginal monitoring device 101 are be plugged it into a personal computer 177 (and the personal computer 177 considers it as a memory device and copies all of the files and data from the intravaginal monitoring device 101 to the personal computer (and optionally this can happen from the personal computer to the device 101 in another variant), the personal computer 177 uses memory device interface 185 to do this); (d) The browser goes on to query mode and the website or server 151 connects to the intravaginal monitoring device 101 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 webpage, real server module 165 or locally populated server module (without connecting to the supporting server 151) extracts information from the intravaginal monitoring device 101 (the client module 183 are not detect intravaginal monitoring device 101, it are be turned off). The data is pushed from device 101 in one variant onto the servers. In another variant, the data is pulled from the device 101 upon interrogation of the device.

These supporting local personal computing devices 171 include cell phones 175, personal computers 177 and video recorder 179, or simply an access point, for instance. Exemplary phones include the Apple brand, iPhone, the Google brand, Android, and Blackberry branded phones. Modes of operation of the devices herein are in one variant managed by applications. The applications are, by way of example, iPhone™ applications, Andriod™ applications, and the like. The applications are delivered to individual devices via the communication networks described herein. The intravaginal monitoring device 101, while inserted in place (inside the vaginal channel) or after usage and removal, allows an authenticated supporting personal computing device 171 to send control signals (as well as firmware and other logistical program codes) and receive images/video clips/sensor data and so forth from the intravaginal monitoring device 101. In one variant, the device 101 harvests and stores data in a memory on the device 101 and has the wireless chip in standby mode or disabled mode. Once the device 101 is removed from the vaginal channel, the device 101 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, device 101 includes a sonogram mode of operation for imaging the position of the fetus head or other body parts. It is appreciated that periodic images are taken by device 101. 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 be initiated by the intravaginal monitoring device 101, upon removal from the vaginal channel, upon switching off the intravaginal monitoring device 101, upon memory full, upon emergency situations, and upon communication button press (if there exists one) by the user. These logistical codes are built into the intravaginal monitoring device 101; however, they might also be received from supporting servers 151, by request. The receiving of images/video clips/sensor data are also be initiated remotely by supporting servers 151 (as per certain logistics) or supporting intravaginal monitoring device client systems and devices 161 (as per a healthcare professional's instructions or commands from a device used by a healthcare professional, for instance).

To make all of the abovementioned functionality and flow of data possible, the intravaginal monitoring device 101 contains a head or cap 105, stem 103, 107 (that contains many of the electronic components including a display 113, some or all of the sensors and batteries), bottom cap 109 (that allows insertion and removal or recharging of batteries and exposes mini USB port for wired communications) and an on/off switch 115. The on/off switch 115 also allows independent selections of modes, wireless on/off, wired on/off (by keeping on clicking 115 until the mode is selected). It also contains a server module (SM) 111 and display management 110 unit.

The user's IMD (Intravaginal Monitoring Device) client systems 171, in addition, contain server module 181, client module 183, memory device interface 185 and application programming interface 187. Similarly, the supporting IMD (Intravaginal Monitoring Device) client systems and devices 161 also contain server module 191, client module 193, memory device interface 195 and application programming interface 197. The supporting IMD (Intravaginal Monitoring Device) client devices 161, for instance, are be a blood pressure monitor or thermometer, which could be in the patient's or healthcare 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) 151, a supporting management company such as 153, 155, 157 or supporting IMD (Intravaginal Monitoring Device) client systems and devices 161.

For instance, a female are purchase intravaginal monitoring device 101 kit, consisting of intravaginal monitoring device 101 as well as a dock where the intravaginal monitoring device 101 can be placed for charging and for communications (alternatively, communication are also occur while in vaginal channel). The female are also sign up with supporting server(s) 151, 153, 155 or 157 and in addition are also sign up for service from local/regional/remote healthcare professionals (which is possible via the supporting IMD (Intravaginal Monitoring Device) client systems and devices 161).

Then, to use the intravaginal monitoring device 101, the female are begin to follow the instructions provided within the intravaginal monitoring device 101 kit, from the supporting servers 151 and/or supporting IMD (Intravaginal Monitoring Device) client systems and devices 161 (via the healthcare professionals from whom the female has requested service). The instructions are be 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 on continuously wearing) or after usage, depending upon the abovementioned specific circumstances, based upon the permission given by the female, the intravaginal monitoring device 101 are transmit the captured images/video clips/sensor data to the supporting server(s) 151 (via user's IMD client systems 171 such as an access point, cell phone 175 or computers 177, for instance). Alternatively, the female are also opt to watch these images/video clips/sensor data all by herself and decide whether to send them to the support server(s) 151 (and then to the healthcare professionals via the supporting intravaginal monitoring device client systems and devices 161), make her own personal decisions, or discard the images/video clips/sensor data. These options are always available to the individual female.

Later, the female are log into her account in the supporting servers 151, selectively upload images/video clips/sensor data of interest to her or the healthcare professionals and then give permission to the supporting IMD (Intravaginal Monitoring Device) client systems and devices 161 of the healthcare professionals for further investigation (of a routine occurrence or a specific condition, for instance). Alternatively, the female are opt to access suggestions from other users, from another server (user forum servers, such as 153, 155 or 157, for instance) by sending certain information stored in her account in the supporting server(s) 151 (for no fees at all, for instance).

Once the healthcare professionals gain access to the images/video clips/sensor data, they are able to provide recommendations/treatments options via the same supporting server(s) 151 back to the female. These recommendations/treatment options are be informed via emails or directly via the supporting server(s) 151 (which is more secured). These cycles of monitoring and recommendations/treatments can be done routinely during routine checkups, menstrual cycles, 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 healthcare professionals.

Note that in all cases of the female, the very same processes are applicable to female animals; in that case instead of female, the case would be that of a female animal in conjunction with its caretaker and the healthcare professional are be a veterinarian.

FIG. 2 is a schematic block diagram illustrating various powering schemes for intravaginal monitoring devices, of the FIG. 1. A typical intravaginal device 205 consists of a head or cup 207, a stem 209 and a bottom cap. Near the bottom cap, there would be an on/off switch that assists the user to switch on and off the intravaginal monitoring device 205 and also selects various modes. The modes are include WiFi on/off, WiMac on-off, various sensors on/off selections, so forth.

As depicted in the intervaginal monitoring device 225, the bottom most part of the stem contains batteries 227. Batteries 227 can be inserted or removed by unscrewing the stem bottom cap 229 (that also contains on/off and mode switch 231), or be rechargeable batteries. Still further down the bottom most part is an unscrewable cap 233, 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 WiFi port, in which case the bottom cap 233 acts as a battery 227 insertions or removal opening.

The depiction 245 shows a rechargeable battery 247 variant of intravaginal monitoring device 245 that comes with a cord 253 to charge the battery 247. The depiction shows a WiFi communication variant (other exemplary variants include WiMax communication functionality and circuitry, cellular phone communication functionality, Bluetooth communication functionality, etc.), but the unit are also have a mini USB port (which exposes itself when the bottom cap 249 is unscrewed). The depiction also shows an on/off or mode selection switch 251.

Finally, the depiction 265 shows another variety of intravaginal monitoring device 265 that comes with a recharging dock 283. When the intravaginal monitoring device 265 is not in use, it can be docked in the recharging dock 283 and after few hours of charging of the batteries 271, the intravaginal monitoring device 265 is ready for use again. The depiction 265 also shows placements of few of sensors 267, 269, 279 and recharging plugs 281.

FIG. 3 is a schematic block diagram illustrating various sensor placement schemes for intravaginal monitoring devices, of the FIG. 1. In specific, the depictions of 305, 325, 345 and 365 show placements of (video) camera 309, 347, sonogram 315, 335, electrocardiogram 331, pressure 329 and temperature 327, 349, 367 sensors and user interfaces that includes an on/off/mode selection switch 313, 333, 353, 373.

In other words, the illustrations 305, 325, 345 and 365 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 devices 305, 325, 345 and 365 include conductive rings 331 (the top one being on the surfaces of the cup or head 307 or 337; through which electrical potential can be measured, for instance, in case of pregnancy, baby's EKG), electrolyte, PH, glucose sensors 311 (these sensors, in reality, are not co-located), infrared temperature sensor window, plate for thermal temperature sensing 327, 349, 367, microphone 315 (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 with fingertip texture 313, 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. The depiction 345 also show bottom cap 359 that can be sealed while screwing back 355 (with a washer 357 that makes the intravaginal monitoring device 345 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 the FIG. 1. Specifically, the illustration depicts typical placement of few of the electronic components 419, 423, 425, 417, 457 within the hermetically sealed transparent cap 413, 453 and stem 421 that includes camera, an infrared thermometer and other sensors, processing circuitry and memory, communication and user interfaces and batteries 425, and a fluid flush cleaner 415, 455 on the surface of the cap 413, 453.

The electronic components are placed over one or more circuit boards, such as the 419. The circuit boards 419 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 a fluid tube 427, 459 for lens cleaning or sperm injection; whereas the depicted fluid tube 427 is built internal to the intravaginal monitoring device 443, the fluid tube 459 is built removably outside of the intravaginal monitoring device 473. Note that the squeeze rubber bulb/ball 429 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 the exterior tube 427 cleaning solution/sperm/drug could be stored in interior intravaginal monitoring device 473 cavity (for instance, within the stem 421), with an injection grommet for initial delivery and pumping (or a pressurized cavity and valve). In addition, drain holes (when the cleaning system 429, 427, 459 and 415, 455 is not used as a sperm delivery device) can be added to the cap 411 for cleaning fluid delivery and vaginal-uterus discharges. Also note that the tube 427 can assist in device insertion-removal.

FIG. 5 is a schematic diagram illustrating placement of the intravaginal monitoring device 511 of FIG. 1, placed so as to face the outer surface of the cervix 543; wherein the device's cap or head 513 takes images of the outer surface of the cervix 543 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 person's reproductive health that are be observed using the intravaginal monitoring device 511, directly or indirectly (by a gynecologist or obstetrician, to determine the health conditions), include Vulva 521, Vaginal Channel 531, Exterior Portion of Vaginal Channel 533, Interior Portion of Vaginal Channel 535, Cervix 541, Outer Surface of Cervix 543, Exterior Orifice (opening) of Cervix 545, Interior Orifice 547, Cervical Channel 549, Uterus 551, Fallopian Tube 561, and Ovary 571.

The intravaginal monitoring device 511 itself contains a cap or head 513 (that contains most of the built in electronics), stem 515 (that aids user in insertion/removal and stabilization/orientation during wear) and bottom cap (or, finger ring) 517 that assists insertion/removal. The stem 515 are, in some configurations, also contain built in electronics. The cap 513 and stem 515 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, 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. The intravaginal monitoring devices 511 are inserted in one variant by applying some lubricant on the surface of the cap 513.

Features that are incorporated in various embodiments of the intravaginal monitoring device 511 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 healthcare 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 device 511 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 the intravaginal monitoring devices 511, 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 presence, 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 the cervix area 543. Other types of plastics or rubber are also used herein, including hypoallergenic materials. Moreover, the cap 513 (or head 513, 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 be 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 the intravaginal monitoring device 511, 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 of FIG. 1. The intravaginal monitoring device 611 contains wired and/or wireless communication interfaces 661 as well as firmware and program & operational logic codes 693 that makes it possible for the intravaginal monitoring device 611 to communicate with the local external electronic devices as well as receive control signals via (immediate) external electronic devices. Moreover, the intravaginal monitoring device 611 also contains memory 681, processing circuitry 641, displays 663 and user input devices 665. The memory 681 additionally contains network management module 683, display management module 685, application programming module 687, external memory management module 689, IMD server module (SM) 691, sensor data 695 and workspace 697.

Firmware and program & operational logic codes 683 allow the intravaginal monitoring device 611 to perform in accordance with specific logic that includes: (a) Receiving and/or executing instructions, in case of wearable intravaginal monitoring device 611, 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 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; 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 the intravaginal monitoring device 611 are include components of one or more of: (a) UV and IR emitter and detectors 621, to monitor temperature; (b) Piezo microphones and speakers 623, to monitor heartbeat sounds of fetus, for instance; (c) Electrolyte and EKG interfaces 625, to take electrocardiogram graphs of heartbeat of a fetus, for instance; (d) Pressure transducers 629, to make pressure measurements within the intravaginal channel, to monitor dilations, for instance; (e) Thermal contact assembly 631, to take temperature measurements in cases of wearable intravaginal monitoring device 611, for instance; (f) Glucose sensor 633, to take glucose measurements; (g) PH sensor 635; and/or (h) Sonogram head unit 639.

In all of the above-mentioned sensor cases, a processing circuitry 641 executes, as mentioned above, the operational logics, and takes measurements at appropriate intervals and also verifies if the limits are exceeded and precautionary actions should be taken. Other components of the intravaginal monitoring device 611 depicted include normal (infrared and ultraviolet) illuminators 667, fixed-manual-auto focus lensing 669, a bunch of photodetector arrays 673, 675 (or one or more arrays positioned at predetermined locations on the device) and fixed-manual-auto focus microscopic lensing 679. The wired and wireless communication interface circuitry 661 also contains: (a) Display interface 649, to support onscreen displays on external monitors, for instance (on a smartphone or other mobile communications device, e.g. two way); (b) External memory interfaces 643, to interface with external computers and deliver the memory contents; (c) Network interface 645; and/or (d) Application programming interface 647, alone or in combination.

FIG. 7 is a schematic diagram illustrating data 755 flow between intravaginal monitoring device 719 and various systems or devices 711, 713, 715, 717, 721 within the supporting network infrastructure. Within the supporting infrastructure, there are various entities such as the 711, 713, 715, 717, 721, all of which in a centralized or distributed form hold sensor data (sensor information/query information) from a plurality of intravaginal monitoring devices 719.

In addition, the data/information 755 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 inputs 713, user IMD support systems/devices 717, practitioner's supporting systems/devices 715, pharmaceutical computing systems/devices 721 and central supporting systems 711 (or in another variant distributed computing systems including but not limited to cloud networks).

Each of these entities is responsible for dissemination of information/data 755 and they flow with permission from the respective entities 711, 713, 715, 717, 721, 719 in an encrypted form. These data or information flow in turn assist R&D systems/devices inputs 713 develop new medicines, user IMD support systems/devices 717 to take care of the data and avail user forum suggestions and recommendations, practitioner's supporting systems/devices 715 to provide treatments to the users of IMD 719, pharmaceutical computing systems/devices 721 to develop or recommend medicines and central supporting systems 711 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 healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts a user's data view page. The snapshot of the user's data view page of the reproductive health management system 811 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 the FIGS. 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 healthcare or a specific reproductive healthcare 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 these 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 timeline 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 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 the FIGS. 9 through 17) also contain tool boxes that are enabled by clicking on the “Tools” icon. The client's browser 825 (which can be the user, third party or the healthcare professional, for instance) also shows a status bar indicating current IMD status 813 and online status 815.

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 healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's record page. This simple records page 911 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 smartphone.

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 in FIGS. 10a and 10b).

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 in FIGS. 10a and 10b. 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon such as 927. The client's browser 925 also shows a status bar indicating current IMD status 913.

FIG. 10a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, 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 healthcare 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 smartphone 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, 1st, 2nd, 3rd trimester, 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 healthcare 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 healthcare 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 healthcare 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1025 also shows a status bar indicating current IMD status 1013.

FIG. 10b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's queries page. This query page 1051 allows the client (which can be anyone who has the access to these queries, including the user, users of a forum, healthcare professional, R&D and pharmaceutical personnel) to read query messages and reply to them (in the next mail window of the FIG. 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 healthcare 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 smartphone 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 have 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 the FIG. 10a), the buttons also allow the user to initiate a new query via the next mail page of FIG. 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1055 also shows a status bar indicating current IMD status 1053.

FIG. 11 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, 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 users view 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 wordprocessed documents, electronic digital photos (e.g. historically taken images by the intravaginal device), etc. The intravaginal device, and or smart phone then processes realtime 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 smartphone 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1125 also shows a status bar indicating current IMD status 1107.

FIG. 12a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's forum page. The forum page 1205 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, 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 physiological 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 the FIG. 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1225 also shows a status bar indicating current IMD status 1207.

FIG. 12b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's forum page. The depiction shows a page that the user arrived into, by clicking the general discussions subcategory in FIG. 12a and 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1255 also shows a status bar indicating current IMD status 1253.

FIG. 13 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's research page.

The research page 1305 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 smartphone 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 the device and system described herein creates a truly 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 online publication organization) 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 smartphone 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled and or disabled by clicking on the “Tools” icon. The client's browser 1325 also shows a status bar indicating current IMD status 1309.

FIG. 14a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's account page. The user accounts page 1405 maintains user's personal information, some of which are be made available to healthcare 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 smartphone, 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, are be made available to other entities (such as healthcare 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 the FIG. 7). In addition, user information and data also include login information that assists the user to quickly login without entering username (handle) and password each time. The login information or data contain a login handle (username 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 healthcare 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 the FIG. 14b) that is made available to healthcare 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1425 also shows a status bar indicating current IMD status 1407 and online status 1409.

FIG. 14b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of another variant of FIG. 1, wherein the snapshot depicts user's account page. The current user accounts page contains same personal information as in the case of FIG. 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 are 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 healthcare 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1457 also shows a status bar indicating current IMD status 1453 and online status 1455.

FIG. 15a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1 in another variant of the system and network, wherein the snapshot depicts user's IMD setup page. IMD setup page 1505 can be exhaustive, nonetheless, many of the information are be filled in automatically by auto detect and remotely by healthcare professionals opting for a follow up of a particular medical condition (by downloading a condition follow up firmware, for instance). The users then onwards simply have 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 be 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1525 also shows a status bar indicating current IMD status 1507 and online status 1509.

FIG. 15b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, 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 of FIG. 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 healthcare 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1557 also shows a status bar indicating current IMD status 1553 and online status 1555.

FIG. 16 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's support page. The user's support page 1605 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 register of medical professionals is provided on a database. The system selects appropriate specialists in the vicinity of the user, e.g. through GPS functionality, 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 physiological 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.

The support page 1605 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 node on the network to transmit appropriate data from the intravaginal device directly. The 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 smartphones and PCs, alone or in combination.

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, online 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1625 also shows a status bar indicating current IMD status 1607.

FIG. 17 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts user's shopping page. The user's shopping page 1705 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.

The shopping page 1705 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 the FIGS. 9 through 17) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The client's browser 1725 also shows a status bar indicating current IMD status 1707.

FIG. 18a is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patients page 1805. The healthcare professional's patients page 1805 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 healthcare professional's patients page 1805 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 healthcare professional's patients page 1805 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's records page 911 of the FIG. 9). For instance, when the healthcare professional selects a patient and click on the view button, the page of FIG. 18b appears (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 any healthcare professional, if unable to remember the patient) can see a photograph or video of the patient by clicking on a face icon 1827 (which pops up an image or small video—of a first visit, for instance). The entire available healthcare professional's patients pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in the FIGS. 18a through 19) also contain tool boxes that can be enabled by clicking on a “Tools” icon. The healthcare professional's browser 1825 also shows a status bar indicating current IMD status 1807. 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 smartphone node on the network.

FIG. 18b is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patient's accounts overview page 1851. The depiction shows another of the healthcare professional's patients page 1851, 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 the FIG. 18c also 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 are 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 healthcare professional's patients page 1855 also comes with many buttons such as view, search, delete, select all, clear selection. For instance, when the healthcare professional clicks on the view button, the page of FIG. 18c appears (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/healthcare 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 the FIG. 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 healthcare professional's patient's accounts overview page 1851 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 healthcare professional's patients pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in the FIGS. 18a through 19) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The healthcare professional's browser 1851 also shows a status bar indicating current IMD status 1853.

FIG. 18c is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patient's records view and invoicing page 1871. The healthcare professional arrives at the current healthcare professional's patient's records view and invoicing page 1871 by clicking on the view button in the page of FIG. 18b. Here, the healthcare 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 healthcare 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 healthcare professional (in the current healthcare professional's patient's records view and invoicing page 1871) 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 healthcare 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 healthcare professional's patients pages, such as the records, queries, mail, forum, research, accounts, IMD setup, support and shopping, among other pages (depicted in the FIGS. 18a through 19) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The healthcare professional's browser 1875 also shows a status bar indicating current IMD status 1873. 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 realtime 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 Ukraine 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 realtime the patient data and provide a consultation.

FIG. 19 is a schematic diagram illustrating a snapshot of one of the reproductive healthcare management web pages or system interfaces of FIG. 1, wherein the snapshot depicts healthcare professional's patient's billing page 1905. The healthcare professional's patient's billing page 1905 is exclusively reserved for billing aspects of the current patient and specialist, based upon the interactions that have taken place so far.

Hence, the healthcare professional's patient's billing page 1905 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 healthcare 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 the FIGS. 18a through 19) also contain tool boxes that can be enabled by clicking on the “Tools” icon. The healthcare professional's browser 1925 also shows a status bar indicating current IMD status 1907. During billing or any other times, if the healthcare specialist is unable to remember the patient, the healthcare 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.

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.

In a first embodiment, an application runs on a mobile phone that displays the data collected from an intravaginal monitoring device. The mobile phone may be an Apple™ brand phone, a Samsung™ brand phone, a Google™ brand phone, a Motorola™ brand phone, a Blackberry™ brand phone, and a Nokia™ brand phone, and so forth. The mobile phone may also be a smart phone.

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 of 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 said 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 abovementioned 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 abovementioned mobile phone may 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 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 abovementioned 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 considered; 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 considered here, consisting of a mobile phone and intravaginal device system to determine peak fertility days, and taking a fertility drug therapy. The abovementioned method and kit may include: (1) having multi-orgasmic sex; (2) drug therapy is 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 include a sonogram image 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 (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, the monitor consisting of a communication link to said mobile phone). The mobile phone 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 determinator (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 operations of the mobile phones may include: (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.

The mobile phone's applications (for processing data received from an intravaginal monitoring device) may include: (1) a mode of operation for obtaining wired data from the intravaginal monitoring device; (2) a mode of operation for obtained data wireless 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, 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 considered.

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 considered. The smart phone supports email, the emails related to: (1) the female reproductive health data; (2) female and medical professional communications.

A mobile phone, further consisting of a mobile communications device, communicatively linked to the abovementioned smart phone; the mobile communications device may include 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 consisting of an intravaginal monitoring device and the smart phone is considered 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, a D-pad, 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 considered. A network consisting 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 considered.

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 considered, in one of the embodiments. Further, the abovementioned 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 considered 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 abovementioned network, the smart phone may also consist of 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™ smartphones, each the smartphone communicatively linked with an individual intravaginal monitoring device is also considered.

A network consisting of a plurality of smartphones each of the smartphones consisting of a smartphone 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 smartphone, 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 considered, in one of the embodiments. The abovementioned camera may be a digital CMOS camera, for example; consisting of an array. The smart phone itself may consist of hardware and software permitting WiFi and or WiMax data communication. An intravaginal monitoring device consisting of hardware and software permitting wireless web browsing is also considered. A network consisting of an intravaginal monitoring device and a smart phone communicating therewith, said smart phone capable of wireless web browsing is also considered.

A network 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 considered. The abovementioned 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 considered. 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 considered. 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 smartphone is also considered. 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 considered.

A network consisting of a device sized and dimensioned to fit into a vagina, and is wearable and self powered, and a mobile communications device consisting of a software suite is also considered. 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 smartphone 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 wifi network, or a WiMax 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 considered 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 healthcare 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 considered in one of the embodiments. The GPS receiver calculates its position by precisely timing the signals sent by the GPS satellites above the Earth. The GPS receiver consists of a trilateration algorithm and the position of the device and the GPR receiver is displayed on a moving map display. The moving map display further consists of direction and speed data; and the GPS receiver and the device further consist of an antenna. The antenna, or optionally multiple antennas, is tuned to the frequencies transmitted by more than one satellite. The communications network or intravaginal monitoring device of any of the disclosures herein, in which the abovementioned receiver is tuned to multiple channels, is also considered. 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 considered.

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 may include 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 considered 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 considered 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 abovementioned mobile communications device further consists of an 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 considered 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 considered 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 considered 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 considered 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 considered 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 considered 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 considered 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 considered in one of the embodiments.

A kit for a mobile communications device for two way communication via a cellular or Internet network, consisting of the mobile communications device, and an intravaginal monitoring device (consisting of an electronic portion) is also considered in one of the embodiments. The kit may include: (1) a plurality of interchangeable heads (containing the electronic portions), sized and dimensioned to provide a field of view with a vagina; (2) a plurality of disposable transparent sleeves, sized and dimensioned to fit over said intravaginal monitoring device; (3) a carrying case; such that it: (i) is sized and dimensioned to fit into a female's handbag; (ii) is shaped so as to provide removability of the mobile communications device and the intravaginal monitoring device; (iii) includes a plurality of pouches and a zipper; and (iv) consists of two halves, and in which said two halves snap shut and snap open; (4) the intravaginal monitoring device consisting of a plurality of sensors for monitoring physiological conditions or events.

A network consisting of: an intravaginal monitoring device for visualizing conditions or events within a vagina, the device consisting of a camera, and having a wireless data transmission mode of functionality, and a remote device, the remote device located outside of a female's body is also considered in one of the embodiments. XXX

There are various types of support architectures that can be found operating within the supporting network infrastructure of FIG. 1. For example, the IMD 105 (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., comprise a computing device selected from one of the supporting personal computing devices 167, the supporting servers 177, and the medical supporting computing devices 187). Together, the computing device and the IMD form a support architecture to service a female reproductive system via a communication link. The communication link can be a direct point to point link or comprise a network routed pathway, both as illustrated by the communication pathways 151.

In other words, a two device support architecture through which analysis engine functionality is provided might involve the IMD and a single one of the supporting personal computing devices 167. It might also involve only the IMD and one of the supporting servers 177. Similarly, a two device support architecture might involve the IMD and one of the systems/devices 187. With any of these support architectures, the functionality of the analysis engine may be fully disposed within either 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. In other words, at a stage 1, raw sensor data from an IMD along with, perhaps, other medical data produced by other medical systems or telemedicine input devices such as, by way of example (telemedicine carts, electronic stethoscopes, external fetal heart rate monitors, external general examination cameras, otoscopes, external ultrasound devices, external vital sign monitors), and manual input data is collected regarding a patient and their underlying physiology. At a stage 2, 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. At stage 3, the analysis engine receives and processes the raw sensor data, any the manual input data, and any 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 or make requests via such systems to the patient, medical staff, or third parties. After receiving any supplemental input, the analysis engine generates the at least the intermediate 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 staffs or patient's) verification might be applied. Either way, once the stage 3 cycling ends, at a stage 4, automated actions based on such assessment can be carried out.

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, 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 devices 187, 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 supporting medical systems 133, 183, 163, 173, supporting information from the medical information 181, 161, 171, 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 useable information from the raw sensor data and pre-processed measurement data, changes over time, colorization information, etc.; b) 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); d) 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 e) 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.

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 staffs or patient's) verification might be applied. Either way, once the stage 3 cycling ends, at a stage 4, 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 regeme 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.

In some embodiments, an analysis engine may not need to be present in a support architecture, but in such cases the various visual working environments set forth on the various supporting devices, so involved, will allow for human analysis to provide the cyclic analysis process with regard to the stages of operation. In other words, in embodiments where there is no analysis engine, a human within the visual working environment can act as a replacement to the analysis engine.

In an embodiment, a method is used by a server (FIGS. 1-11) in a communication network, e.g. communication network 391. The communication network has a plurality of sensor devices (e.g. 105, 215, 221) and a support computer (e.g. 241, 245, 321, 323, 325, 353). It is appreciated that the management of a group of in birthing center, and out of birthing center pregnant females is facilitated using 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 patients are provided instructions on their mobile phones 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 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, information related to the sensed data, in whole or in part, on pregnant females B-F. Pregnant female B is in passive labor, has a window with her picture, relevant medical information, location, an image of her cervix (including all relevant clinical parameters), contraction information, breaking of the waters status, information sensed related to her fetus, etc. On the same (or other screen), Pregnant female C is in active labor. A window with Female C's photo, room number, cervical diameter (greater than 6 cm), effacement information, temperature, next of kin contact information, fetal information appear in the visual work environment. The nurse midwife 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 midwife Z. Nurse midwife Z notices several disturbing trends concerning pregnant female D on a window relating to pregnant female C. A graph of cervical depth 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 on her visual working environment. Nurse midwife Z immediately calls 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 Nurse Midwife Z has 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 was provided to the ambulance operator on 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. An alert was provided to pregnant female D's husband who was at work, and the husband and wife immediately discuss. D's husband tracks his wife's physical location in the ambulance using 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.

By way of further example, pregnant female E is 37 weeks pregnant during her first pregnancy, and being home monitored with an intravaginal monitoring device 105. Pregnant female E feels period contractions. She feverishly calls her husband and has her husband leave his job as a school bus driver, and drive home immediately believing she is going into labor. She calls the birthing center from her mobile phone 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. Nurse Mid Wife Z reviews pregnant female E's profile on her visual working environment in real time and immediately shares the profile with Doctor E who views it on his iPad on the golf course in Hawaii. The visual working environment display 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. Nurse Mid Wife Z consults with Doctor E, and Doctor E determines that pregnant female E is having Brixton-Hicks contractions, and that she is not in active labor. Doctor E, presses a button on his wirelessly connected iPad, 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 monitored by the intravaginal device 105 with its sensors. At this time Nurse Midwife Z, reviews pregnant patient E's profile remotely and determines that the sensed profile parameters indicate that pregnant patient E is going into normal labor, and instructs her to come to the birthing center for admission. Pregnant patient E's husband is alerted that is the “real deal,” and that the baby will soon arrive. 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 on his smart phone of the impending delivery with an alert in advance so he is able to hop out of the shower, review patient E's pregnancy profile, and deliver the healthy baby girl just in time. 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.

Each of the plurality of sensor devices capture sensor data via a vaginal channel 217 of a female reproductive system. The method includes establishing communication with the plurality of sensor devices, receiving the sensor data captured by at least one of the plurality of sensor devices via the vaginal channel 217 of the female reproductive system, generating display data (e.g. on devices 245, 241, 323, 351, 353) based on the sensor data received; and, delivering the display data for display (e.g. as in FIG. 9) to the support computer. In one embodiment, the communication established flows the communication network (e.g. FIGS. 3 and 8). The server supports a forum relating to the female reproductive system, or optionally: a general purpose forum, a social network, a specific topic of interest forum, a company forum, a product related forum, a technical service forum, a medical condition related forum, and the like. In a variant, a server (e.g. on the communication network, Internet, Intranet, alone or in combination), supports sales relating to the female reproductive system. Sales are also of products and services in general in another variant. These include baby products, birth control, medical services, baby furniture, hospitals services, drugs, therapies, baby shampoo, toys, baby clothing, expectant mother clothing and apparel, baby diapers, cosmetics, Lamaze classes, parenting class, birthing classes, yoga, and the like.

In another embodiment, the method includes providing medical referral data. In yet another embodiment, the method includes providing medical research data. By way of example, a female uses the device described herein in a pregnancy test mode of operation. The device sends an alert to the female that there is an indication that she is pregnant, e.g. as a result of an analysis of cervical color change. At this point the system based upon the sensor data and indication, provides the female a list of obstetricians in her local area (by way of the GPS mode of operation of the device) who can provide her services, along with locations of the physicians or practice groups, openings for appointments, calendars, contact information (e.g. including emails, telephone numbers), and can provide a link or button on device 241 so that the female can call to schedule an appointment or an appointment is scheduled via a web site. Similarly, if the device and method sense the possible presence of an STD, a physician referral is also provided. The female may also desire more medical research to educate herself regarding the condition that was sensed by the device, and links and relevant information are automatically forwarded to her cell phone 241 or computer 245 so that she can educated herself

In another embodiment a method used by a server in a communication network (FIGS. 1-3) to make a related data selection from a plurality of data is provided. The communication network includes a medical sensor device that captures sensor data via a vaginal channel 217 of a female reproductive system in one variant of the invention. In an alternate variant of the invention, a multi-purpose imaging device (not shown) is used in the method, which images body cavities other than a vaginal body cavity. The method includes, the method includes establishing communication with the medical sensor device; receiving the sensor data captured by the medical sensor device; and, selecting the related data from the plurality of data, the selection being based at least in part on the sensor data received. The plurality of data includes a plurality of advertisement data. Examples of advertisement data are provided above. In a variant, the plurality of data include a plurality of sales data, marketing data, and the like. In yet another embodiment, the plurality of data include medical research data, referral data, alone or in combination with the other described herein.

In an embodiment, the method also includes at least assisting, and/or assisting in drawing a conclusion based at least in part on the sensor data received. The selection is based at least in part on the sensor data received comprising a selection based at least in part on the conclusion drawn. For example, if the sensor data indicates that a female has a known STD, e.g. Chlamydia. The advertisement data selected includes therapies to treat chlamydia, a referral to who can confirm a diagnosis, alone or in combination. It is appreciated that highly specific, targeted potential customers for treatments, drugs and therapies are identified using the method described herein, as well as specific treatments, drugs and therapies for the specific condition are further identified, leading to a perfect match between product, and/or service offering and customer. The method also serves to educate the female as to treatment options and efficacies of treatment options (by presenting efficacy, contraindication, cost data) associated with a particular course of therapy.

In another embodiment, a method performed by at least one device associated with a female reproductive system (e.g. 105, 215, 231). The female reproductive system can have a variety of physiological states. These include, for example, a healthy physiological state, an unhealthy physiciolgical state, a diseased physicological state, an abnormal physiological state, a normal physiological state, a fertile physiological state, an infertile physiological state, a pregnant physiological state, a non pregnant physiological state, a physiological state where the female is in labor, a physiological state where the woman is in delivery, a physiological state where a pregnant woman has a normal fetus in her womb, a physiological state where the woman has a distressed fetus in her womb, a physiological state that requires immediate intervention, among a host of other physiological states. The method includes retrieving first data captured by a first sensor located within the reproductive system of a female; retrieving second data captured by a second sensor associated with the female; and presenting a visual working environment on a screen (e.g. of one or more of devices 241, 245, 323, 321, 351, 353, alone or in combination), the visual working environment containing visual data related to the first data and the second data to support drawing of a conclusion related to the physiological state (e.g. FIGS. 10 and 11). The retrieval of the first data and the second data occurs during a session in which the first data and the second data are captured. The presentation of the visual working environment occurs during that session in one embodiment. In another variant, the retrieval of the first data and the second data occurs over a plurality of sessions so that in each of the plurality of sessions a portion of the first data and a portion of the second data are captured.

It is appreciated that a medical professional (or layperson—female patient, husband, third party, etc.), based upon his clinical need to understand a patient's (and/or fetus') requirements for one or more interventions (or lack of need therefor), is provided real time, substantially real time, historical data, alone or in combination on a screen of devices 321, 353 in a visual working environment. By way of example, the visual working environment (for a pregnant female in labor—normal or premature) based upon or partially based upon sensor data (and/or GPS data) includes, alone or in combination, a graphical representation of contraction rate, graphical representation of contraction intensity, fetal heart rate in realtime, graphical representation of fetal heart rate over time, maternal heart rate in real time, maternal heart rate in real time, real time cervical status, over time cervical status, real time cervical depth, overtime cervical depth, temperature in realtime, temperature over time, an image of the female's face, an image of the medical professional's face, week or pregnancy, number of pregnancies, age, physiologic parameter over time, physiologic parameter in real time, GPS coordinate information of female, navigation information to birthing center, historical alert information, medical history information, and contact information.

In another embodiment, a first portion of the first data corresponding to a first of the plurality of sessions and a second portion of the first data corresponding to a second of the plurality of sessions are presented in contrast to also support the drawing of the conclusion. The conclusion is related to the physiological state that includes fetal condition. In another embodiment, an alert is generated relating to the physiological state based on the first data captured by the first sensor. The alert can also be generated based at least in part on the first data captured by the first sensor.

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. These species include, by way of example, endangered species, domesticated animals, wild animals, cows, female horses, sows, female goats. Particular utility is found in high value animals which are prized for their genetic makeup. The devices and methods described herein are used in a method to detect estrus, and also in a method to properly and optimally time insemination for artificial insemination of these animals. The devices and methods described herein are used, alone or in combination with, hormonal artificial insemination protocols. By way of example, a device having a housing sized and dimensioned to properly fit into a female animal is inserted into the animal's vagina. A plurality of different sensor types (intravaginal, e.g. temperature sensor, motion sensor, accelorometer) sense parameters associated with a peak insemination window of time. The visual working environment presents to an artificial insemination technician on device 323, 321, graphs or alerts related to the peak insemination window of time. The device automatically inseminates the animal with semen based upon or partially based upon the sensor data, with or without the manual intervention of the artificial insemination technician. Post insemination, the device and method determines if the animal did indeed get pregnant by sensing pregnancy related parameters, and posts alerts. It is appreciated that the device and method is particularly useful in managing high value animals and large herds.

The terms “circuit” and “circuitry” as used herein are refer to an independent circuit or to a portion of a multifunctional 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 be 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

1. A method used by a server in a communication network, the communication network also having a plurality of sensor devices and a support computer, each of the plurality of sensor devices capturing sensor data via a vaginal channel of a female reproductive system, the method comprising:

establishing communication with the plurality of sensor devices;
receiving the sensor data captured by at least one of the plurality of sensor devices via the vaginal channel of the female reproductive system;
generating display data based on the sensor data received; and
delivering the display data to the support computer.

2. The method of claim 1, wherein the communication established flows via the communication network.

3. The method of claim 1, wherein the server supports a forum relating to the female reproductive system.

4. The method of claim 1, wherein the server supports sales relating to the female reproductive system.

5. The method of claim 1, further comprising providing medical referral data.

6. The method of claim 1, further comprising providing medical research data.

7. A method used by a server in a communication network to make a related data selection from a plurality of data, the communication network comprising a medical sensor device that captures sensor data via a vaginal channel of a female reproductive system, the method comprising:

establishing communication with the medical sensor device;
receiving the sensor data captured by the medical sensor device; and
selecting the related data from the plurality of data, the selection being based at least in part on the sensor data received.

8. The method of claim 7, wherein the plurality of data comprises a plurality of advertisement data.

9. The method of claim 7, wherein the plurality of data comprises a plurality of sales data.

10. The method of claim 7, wherein the plurality of data comprises medical research data.

11. The method of claim 7, wherein the plurality of data comprises referral data.

12. The method of claim 7, further comprising at least assisting in drawing a conclusion based at least in part on the sensor data received, and the selection that is based at least in part on the sensor data received comprising a selection based at least in part on the conclusion drawn.

13. A method performed by at least one device associated with a female reproductive system, the female reproduce system having a physiological state, the method comprising:

retrieving first data captured by a first sensor located within the reproductive system of a female;
retrieving second data captured by a second sensor associated with the female; and
presenting a visual working environment on a screen, the visual working environment containing visual data related to the first data and the second data to support drawing of a conclusion related to the physiological state.

14. The method of claim 13, wherein the retrieval of the first data and the second data occurs during a session in which the first data and the second data are captured.

15. The method of claim 14, wherein the presentation of the visual working environment occurs during the session.

16. The method of claim 13, wherein the retrieval of the first data and the second data occurs over a plurality of sessions, in each of the plurality of sessions a portion of the first data and a portion of the second data are captured.

17. The method of claim 16, wherein a first portion of the first data corresponding to a first of the plurality of sessions and a second portion of the first data corresponding to a second of the plurality of sessions are presented in contrast to also support the drawing of the conclusion.

18. The method of claim 13, wherein the conclusion related to the physiological state comprising a fetal condition.

19. The method of claim 13, further comprising delivering an alert related to the physiological state based on the first data captured by the first sensor.

20. The method of claim 19, further comprising generating the alert based at least in part on the first data captured by the first sensor.

Patent History

Publication number: 20110190581
Type: Application
Filed: Sep 27, 2010
Publication Date: Aug 4, 2011
Inventors: James D. Bennett (Hroznetin), Andrew W. Ziarno (Thalheim)
Application Number: 12/890,805

Classifications

Current U.S. Class: With Camera Or Solid State Imager (600/109)
International Classification: A61B 1/04 (20060101);