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 lust 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.

1 . A computer-implemented system for assessing female fertility, the system comprising:
 a. an intravaginal capsule configured for retrieval, wherein the intravaginal capsule comprises:
 a housing; 
 a camera mounted to the housing and configured to receive computer-implemented signals to obtain at least one cervical image; 
 one or more first sensors mounted to the housing and configured to measure one or more intravaginal parameters relating to the female fertility; 
 one or more second sensors mounted to the housing and configured for continuous measurement of at least one biochemical parameter; 
 at least one computer processor mounted to the housing, 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 
 at least one memory device; and 
   b. an electronic 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,   wherein at least one of said one or more second sensors is configured to contact vaginal fluid with a sensor substance adapted to reversibly interact with an analyte of interest, the sensor substance configured to emit electromagnetic energy when the analyte of interest is in contact with the sensor substance and electromagnetic excitation energy is received by the sensor substance.   
     
     
         2 . The system of  claim 1 , wherein the housing further comprises one or more of an image-capture 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 . (canceled) 
     
     
         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 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. 
     
     
         7 . (canceled) 
     
     
         8 . The system of  claim 6 , wherein the alert signal is a Flibanserin monitoring signal. 
     
     
         9 . The system of  claim 1 , wherein the system is configured for initiating use of and controlling the retrievable capsule and the electronic 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 . (canceled) 
     
     
         12 . (canceled) 
     
     
         13 . An intra-body communication and data processing system for monitoring fertility in a patient in need thereof, the system comprising:
 a capsule configured to be reversibly insertable into the patient's body;
 a device spaced apart from the capsule, wherein the capsule and the device are configured for communication including transmitting one or more signals between the capsule and the device; and 
   a receiver for detecting the one or more signals to monitor the fertility, wherein the one or more signals carry physiological information selected from the group consisting of 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 illumination signal, and one or more cervical images,   wherein the one or more signals are configured for comparison with 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, 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 . (canceled) 
     
     
         17 . (canceled) 
     
     
         18 . (canceled) 
     
     
         19 . A method of in vivo monitoring of a pregnant individual, comprising the steps of:
 providing a retrievable device comprising a housing;   inserting the retrievable device in the vaginal tract of the individual;   activating a light source mounted to the housing to illuminate at least a portion of a cervical opening of the individual;   operating an image capture device mounted to the housing to capture an image of at least a portion of the cervical opening of the individual;   operating one or more first sensors mounted to the housing to measure one or more intravaginal parameters relating to the female fertility;   operating one or more second sensors mounted to the housing to measure at least one biochemical parameter;   controlling the operation of the image capture device with a trigger signal generated based on the at least one measurement corresponding to a labor contraction;   automatically generating fertility information based on one or more of the at least one biochemical parameter and the one or more intravaginal parameters; and   transmitting the image and the fertility information to a wearable device, wristwatch, or smart phone.   
     
     
         20 . The method of  claim 15  wherein the biochemical parameter is an analyte in a vaginal fluid of the individual, the operating of said one or more second sensors measuring concentration of said analyte concentration continuously.