Device and methods for in vivo monitoring of an individual

• US 10,349,820 B2
• Filed: 07/12/2011
• Issued: 07/16/2019
• Est. Priority Date: 07/12/2010
• Status: Active Grant

• Current Assignee: Therasyn Sensors Inc.
• Original Assignee: Therasyn Sensors Inc.
• Inventors: Schentag, Jerome J., Bright, Frank V., D'Andrea, David T.
• Primary Examiner(s): Leubecker, John P
• Assistant Examiner(s): Ghimire, Shankar Raj
• Application Number:
  US13/808,463
• Publication Number:
  US 20130225922A1
• Time in Patent Office: 2,926 Days
• Field of Search: 600160
• CPC Class Codes: A61B 1/00186 with imaging filters
• CPC Class Codes: A61B 1/041 Capsule endoscopes for imaging
• CPC Class Codes: A61B 1/043 for fluorescence imaging
• CPC Class Codes: A61B 1/051 Details of CCD assembly
• CPC Class Codes: A61B 1/0684 using light emitting diodes [LED]
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/435 Assessing cervix alteration or dilation

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, etc.) 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.

Claims

1. A retrievable device for in vivo monitoring of a pregnant individual, comprising:

a first housing having a light source configured to illuminate at least a portion of a cervical opening of the individual, an image capture device positioned to capture an image of at least a portion of the cervical opening of the individual, a 3-axis accelerometer, a connector configured to removably connect to a second housing, and a data interface configured to communicate with a mating data interface of the second housing;

a tether attached to the first housing for retrieving the device;

wherein the first housing is configured to be inserted in a vaginal tract, retrieved from the vaginal tract, and reconfigured with one or more additional sensors before reinsertion in the vaginal tract;

the device further comprising a second housing having a sensor, the second housing having;

a mating connector configured to cooperate with the connector of the first housing for removable connection with the first housing; and

a mating data interface configured to cooperate with the data interface of the first housing for communication with the first housing; and

wherein the sensor is an analyte sensor configured to obtain at least one measurement of a concentration of analyte in a vaginal fluid of the individual, the analyte sensor;

a) comprising a sensor substance in a sol-gel material such that the sensor substance reversibly interacts 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; and

b) configured to be in contact with the vaginal fluid.

2. The device of claim 1, wherein the accelerometer is electrically connected to the image capture device, the accelerometer being configured to generate a signal for controlling the operation of the image capture device.

3. The device of claim 1, wherein the sensor is an analyte sensor configured to obtain at least one measurement of a concentration of analyte in a vaginal fluid of the individual, the analyte sensor:

a) comprising a sensor substance in the form of an antibody bonded to a reporter molecule such that the antibody interacts with an analyte of interest, the reporter configured to emit electromagnetic energy when the analyte of interest interacts with the antibody; and

b) configured to be in contact with the vaginal fluid.

4. The device of claim 1, wherein the analyte sensor is configured to continuously measure a concentration of analyte in the vaginal fluid.

5. The device of claim 1, wherein the analyte sensor further comprises:

a detector configured to detect electromagnetic energy emitted by the sensor substance; and

a controller in electronic communication with the detector for measuring a concentration of analyte based on the detected electromagnetic energy.

6. The device of claim 1, wherein the analyte sensor further comprises an electromagnetic excitation energy source configured to provide electromagnetic excitation energy to the sensor substance.

7. The device of claim 1, further comprising one or more sensor modules configured to be removably connected between the first housing and the second housing, each of the one or more sensor modules having at least one additional sensor.

8. The device of claim 7, wherein at least one of the one or more sensor modules are configured to detect multiple analytes.

9. The device of claim 1, wherein the first housing further comprises a parametric sensor for measuring a physical parameter of the environment external to the second housing.

10. The device of claim 9, wherein the parametric sensor comprises a piezoelectric pressure sensor.

11. The device of claim 9, wherein the physical parameter is sound, pH, temperature, or pressure.

12. The device of claim 1, further comprising a transmitter and/or a receiver for communicating with an external device.

13. The device of claim 1, further comprising a receiver in electronic communication with the image capture device and the image capture device captures an image based on a signal from the receiver.

14. The device of claim 1, further comprising an electronic storage device electrically connected to the image capture device.

15. A method of in vivo monitoring of a pregnant individual, comprising the steps of:

providing a retrievable device comprising;

a first housing having a light source configured to illuminate at least a portion of a cervical opening of the individual, and an image capture device positioned to capture an image of at least a portion of the cervical opening of the individual, a 3-axis accelerometer electrically connected to the image capture device, a connector configured to removably connect to a second housing, and a data interface configured to communicate with a mating data interface of the second housing;

a tether attached to the first housing for retrieving the device; and

wherein the connected first housing is configured to be inserted in a vaginal tract;

inserting the retrievable device in the vaginal tract of the individual;

using the retrievable device to make at least one measurement of a first property of the individual;

using the tether to extract the retrievable device from the individual;

adding one or more sensors to the first housing;

reinserting the retrievable device in the vaginal tract of the individual; and

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.

16. The method of claim 15, further comprising the step of using the image capture device to capture at least one image of a portion of the cervical opening of the individual.

17. The method of claim 15, wherein the retrievable device further comprises a second housing having an analyte sensor, a mating connector configured to cooperate with the connector of the first housing for removable connection with the first housing, and a mating data interface configured to cooperate with the data interface of the first housing for communication with the first housing, and wherein the analyte sensor is used to make at least one measurement is of a concentration of an analyte in a vaginal fluid of the individual.

18. The method of claim 17, wherein the at least one measurement of analyte concentration is made continuously.

19. The method of claim 15, wherein the first housing further comprises a parametric sensor and the at least one measurement is of a physical parameter of an environment external to the device.

20. The method of claim 15, further comprising the step of transmitting the at least one measurement by way of a transmitter.

21. The method of claim 15, further comprising the step of receiving a control signal at the retrievable device from a remote transmitter.

22. The method of claim 15, further comprising the steps of:

configuring the retrievable device to make at least one measurement of a second property of the individual;

reinserting the retrievable device in the individual; and

using the reconfigured retrievable device to make at least one measurement of the second property of the individual.