Wireless vaginal capsule and methods for monitoring fertility and pregnancy

Abstract

The present invention may be embodied as a retrievable device capable of sensing one or more properties of an individual (e.g., chemical or physical parameters). In use, the retrievable device can continuously determine the chemical concentrations within the vaginal tract. An embodiment of the retrievable device comprises a first housing having a light source and an image capture device, a second housing removably connected to the first housing and having a sensor, and a fitting for retrieving the device. The sensor may be an analyte sensor configured to obtain at least one measurement of a concentration of an analyte in a fluid. The analyte sensor comprises a sensor substance in a sol-gel material so the sensor substance reversibly interacts with an analyte of interest. In addition, the retrievable device can be configured to determine different physical parameters and re-implanted.

What is claimed is: 
     
         1 . A computer-implemented system for assessing female fertility, the system comprising:
 a. an intravaginal capsule configured for retrieval by the female, wherein the intravaginal capsule comprises:
 i. a first housing comprising a camera configured to receive computer-implemented signals to obtain at least one cervical image, and one or more sensors configured to measure one or more intravaginal parameters relating to the female fertility; 
 ii. a second housing that is removably attached to the first housing, wherein the second housing comprises one or more sensors configured to receive computer-implemented instructions for continuous measurement of at least one biochemical parameter; 
 iii. at least one computer processor, wherein the computer processor provides fertility information based on one or more of the at least one biochemical parameter and the one or more intravaginal parameters; and 
 iv. at least one memory device; and 
   b. an electronic bi-directional connection configured to transmit the at least one cervical image to at least one computing device, wherein the computing device is selected from the group consisting of a wearable device, a wristwatch and a smartphone; and   c. at least one operator capable of initiating the bi-directional connection to capture and transmit one or more of the intravaginal parameters and the at least one cervical image.   
     
     
         2 . The system of  claim 1 , wherein the first housing further comprises one or more of an image-capture device, an acoustic-detection device, and at least one parametric sensor configured to measure the one or more intravaginal parameters, and wherein the one or more intravaginal parameters are selected from the group consisting of vaginal temperature, labor-contraction timing and intensity, vaginal pressure and vaginal motion. 
     
     
         3 . The system of  claim 2 , wherein the one or more cervical images are obtained by the image-capture device, and wherein the image capture device is configured for one or more of high-resolution imaging, video capture, and intravaginal illumination. 
     
     
         4 . The system of  claim 2 , wherein the acoustic-detection device is configured to monitor one or more of fetal and maternal cardiometries. 
     
     
         5 . The system of  claim 2 , wherein a 3-axis accelerometer is used to detect the vaginal motion, and wherein sexual arousal is indicated when the 3-axis accelerometer detects vaginal motion that is increased compared to a reference standard. 
     
     
         6 . The system of  claim 2 , wherein the at least one operator receives the fertility and pregnancy information on the wearable device, the wristwatch or the smartphone or any combination thereof, and wherein a detected reference standard deviation in one or more of the vaginal temperature, labor-contraction timing and intensity, vaginal pressure, and vaginal motion triggers an alert signal to the at least one individual. 
     
     
         7 . The system of  claim 6 , wherein the alert signal is selected from the group consisting of a fertility signal, an ovulation signal, a hormonal signal, a pregnancy signal, a pregnancy-labor signal, a cervical dilation signal, a contraction signal, an image-capture alert signal, an illumination signal, a time-synchronized fertility and pregnancy signal, and a drug-monitoring signal. 
     
     
         8 . The system of  claim 7 , wherein the drug-monitoring signal is a Flibanserin monitoring signal. 
     
     
         9 . The system of  claim 1 , wherein the at least one individual is capable of initiating and controlling the retrievable capsule and the electronic bi-directional connection. 
     
     
         10 . The system of  claim 9 , wherein the initiation and controlling are selected from the group of consisting of positioning the retrievable capsule intravaginally, receiving the intravaginal parameters on the wearable device, wristwatch or smartphone, image capturing, transmission of the cervical images, and intravaginal illumination. 
     
     
         11 . The system of  claim 9 , wherein the initiation and controlling further comprises interactive data, sharing of fertility-pregnancy metrics selected from the group consisting of health-related data records, personal identification data, inputted health data, captured health data, application programming interface (APP) accessible data, health-records, electronic medical record (EMR), scanned data, wearable device data, wristwatch data, smartphone data, and optical character recognition (OCR) captured data. 
     
     
         12 . The system of  claim 1 , wherein physiological data from at least one of the one or more sensors is acquired from a female patient, and wherein at least one of the one or more sensors is a passive sensor that does not require activation by the female, and further wherein the data is transmitted to a processor and compared to control data for the fertility assessment of the female patient. 
     
     
         13 . An intra-body communication and data processing system for monitoring fertility in a patient in need thereof, the system comprising:
 a. a capsule, wherein the capsule comprises:
 i. first device reversibly implanted by the patient into the patient's body; and 
 ii. a second device spaced apart from the first device, wherein the first device and the second device are configured for two-way communication through at least a portion of the patient's body by transmitting one or more signals between the first device and the second device; and 
   b. a receiver for detecting the one or more signals to monitor the fertility, wherein the one or more signals are selected from the group consisting of maternal heart-rate, fetal heart-rate, vaginal contractions, vaginal temperature, vaginal pH, vaginal fluid glucose, vaginal fluid hemoglobin, labor-contraction timing and intensity, vaginal pressure, vaginal motion, ovulation parameters, hormonal imbalances, cervical dilation, vaginal contraction, an image-capture alert, an illumination signal, and one or more cervical images,   c. wherein the one or more signals are compared to a reference signal from the patient to monitor fertility in the patient.   
     
     
         14 . The system of  claim 13  further comprising:
 a. at least one computer processor, wherein the computer processor provides fertility information to the patient based on the one or more signals; and 
 b. at least one memory device. 
 
     
     
         15 . The system of  claim 13 , wherein the capsule further comprises one or more of an image-capture device, an acoustic-detection device, and at least one parametric sensor configured to measure the one or more signals, and wherein the image capture device is configured for one or more of high-resolution imaging, video capture, and intravaginal illumination. 
     
     
         16 . The system of  claim 13 , wherein the patient initiates and controls the capture of the one or more signals. 
     
     
         17 . The system of  claim 16 , wherein the initiation and controlling are selected from the group of consisting of disposing the capsule intravaginally, receiving intravaginal parameters on the wearable device, wristwatch or smartphone, image capturing, transmission of cervical images, and intravaginal illumination. 
     
     
         18 . The system of  claim 16 , wherein the initiation and controlling further comprises interactive data sharing of fertility metrics selected from the group consisting of health-related data records, personal identification data, inputted health data, captured health data, application programming interface (APP) accessible data, health-records, electronic medical record (EMR), scanned data, wearable device data, wristwatch data, smartphone data, and optical character recognition (OCR) captured data.