IP Library Granted Patent US 12,446,865
Granted Patent B2
US 12,446,865 · App. 16/648,445 · Granted Oct 21, 2025

System and method for detecting pregnancy related events

Inventor: Peter Stein (Zurich, CH)
A61B10/0012A61B5/02405A61B5/0816A61B5/681A61B2010/0016A61B2010/0019A61B2010/0029
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Quick Facts
Patent No.
US 12,446,865
App. No.
16/648,445
Granted
Oct 21, 2025
Kind
B2
Abstract

An electronic system for detecting events related to a pregnancy of a female human, such as ovulation, conception, and miscarriage, comprises a wearable device ( 1 ) with a sensor system ( 100 ) worn in contact with the skin for measuring one or more physiological parameters. A processor ( 13, 30, 40 ) is configured to receive a user entry indicating a time of actual menses, and to determine time windows, for analyzing physiological parameters of the female human, using the time of actual menses. The processor is further configured to detect the pregnancy related events by comparing the physiological parameters, determined and recorded for a first time window, with those determined and recorded for a second time window, to indicate the pregnancy related events when defined detection criteria are met, and to use the user input for pregnancy related events to optimize the detection of these events with machine learning trained algorithms.

Claims (36)

1. An electronic system for detecting a pregnancy related events to a pregnancy of a female human, the pregnancy related events consisting at least one of: ovulation, conception, or miscarriage, the system consisting of:

a wearable device including a sensor system configured to be worn in contact with skin of the female human and to measure one or more physiological parameters of the female human;

a processor configured to:

receive from the female human an entry which indicates a time of an actual menses, and to determine time windows, for analyzing the one or more physiological parameters of the female human, using the time of the actual menses; and

detect the pregnancy related events by comparing first physiological parameters of the female human with second physiological parameters of the female human, wherein the first physiological parameters are determined and recorded for a first one of the time windows and the second physiological parameters are determined and recorded for a second one of the time windows; and

indicate to the female human the pregnancy related events when the comparison of the first physiological parameters and the second physiological parameters meets defined detection criteria, and wherein the processor is configured to:

detect occurrence of the conception and to indicate to the female human a pregnancy status when a first set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a second final phase of a second cycle, has a higher value than the first set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows in a first final phase of a first cycle, by a defined threshold value, the first set of the first and the second physiological parameters of the female human including at least one of: a breathing rate of the female human, a heart rate of the female human, or a skin temperature of the female human, and wherein the processor is configured to set a starting time of the first one of the time windows in the first final phase of the first cycle to ten days after the ovulation in the first cycle, and to set a starting time of the second one of the time windows in the second final phase of the second cycle to ten days after the ovulation in the second cycle,

detect the miscarriage and to indicate to the female human the miscarriage when a third set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows, after the detection of the occurrence of the conception, shows a decreasing value by the defined threshold value from the third set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows preceding the second one of the time windows, the third set of the first and the second physiological parameters of the female human including at least one of: the heart rate of the female human or the skin temperature of the female human, and

detect an ovulatory cycle and to indicate to the female human the ovulatory cycle when a fourth set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a current final phase of a current cycle, shows a variation to the first physiological parameters, determined and recorded in the current cycle for the first one of the time windows preceding the second one of the time windows in the current final phase of the current cycle, which the variation is greater by the defined threshold value than the variation expected for an anovulatory cycle, the fourth set of the first and the second physiological parameters of the female human including at least one of: the heart rate of the female human, a standard deviation of beat to beat of a heart rate variability, a heart rate variability ratio, a heart rate variability parameter, or the skin temperature of the female human.

2. The electronic system of claim 1 , wherein the processor is further configured to receive from the female human a first entry which indicates an actual occurrence of one of the pregnancy related events for the female human, and to adapt the defined detection criteria for the pregnancy related events indicated by the female human, using the first and the second physiological parameters determined and recorded for the female human.

3. The electronic system of claim 1 , wherein the processor is further configured to calculate average values of the first and the second physiological parameters of the female human, determined and recorded for the first one of the time windows and for the second one of the time windows, and to compare the average values of the first physiological parameters calculated for the first one of the time windows to the average values of the second physiological parameters, calculated for the second one of the time windows.

4. The electronic system of claim 1 , wherein the sensor system is configured to determine at least one of: the breathing rate of the female human, the heart rate of the female human, the skin temperature of the female human, the heart rate variability parameter of the female human, a skin bioimpedance of the female human, or a perfusion of the female human; and the processor is configured to detect the pregnancy related events by comparing at least one of: the breathing rate of the female human, the heart rate of the female human, the skin temperature of the female human, the heart rate variability parameter of the female human, the skin bioimpedance of the female human, or the perfusion of the female human, determined and recorded for the first one of the time windows, respectively with at least one of: the breathing rate of the female human, the heart rate of the female human, the skin temperature of the female human, the heart rate variability parameter of the female human, the skin bioimpedance of the female human, or the perfusion of the female human, determined and recorded for the second one of the time windows, and to indicate to the female human the pregnancy related events when the comparing meets the defined detection criteria.

5. The electronic system of claim 1 , wherein the processor is further configured to use the time of the actual menses, indicative of the first cycle, to determine a first time for the second cycle following the first cycle; and to detect the pregnancy related events by comparing the first physiological parameters of the female human, determined and recorded for the first one of the time windows in the first cycle, with the second physiological parameters of the female human, determined and recorded for the second one of the time windows in the second cycle, and to indicate to the female human the pregnancy related events when comparing the first and the second physiological parameters meets the defined detection criteria.

6. The electronic system of claim 1 , wherein the processor is configured to detect the occurrence of the conception and to indicate to the female human the pregnancy status when a second set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in the second final phase of the second cycle, has a lower value than the second set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows in the first final phase of the first cycle, by the defined threshold value, the second set of the first and the second physiological parameters of the female human including at least one of: a low frequency component of the heart rate variability of the female human, the heart rate variability ratio of the female human, or a perfusion of the female human.

7. The electronic system of claim 1 , wherein the processor is further configured to determine an expected menstruation and to indicate to the female human the expected menstruation, when a fifth set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a non-conceptive cycle, shows defined deviation from values of the fifth set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows preceding the second one of the time windows of the non-conceptive cycle, the fifth set of the first and the second physiological parameters of the female human and the defined deviation including at least one of: the heart rate of the female human showing a decreasing value, a perfusion index of the female human showing a decreasing value, the skin temperature of the female human showing a decreasing value, the breathing rate of the female human showing an increasing value, the heart rate variability ratio of the female human showing an increasing value, or a bio-impedance of the female human showing an increasing value.

8. The electronic system of claim 1 , wherein the electronic system further comprises a data store, and the processor is configured to store the one or more physiological parameters measured by the sensor system, and to detect the pregnancy related events, using the one or more physiological parameters of the female human stored during a plurality of cycles.

9. The electronic system of claim 1 , wherein the processor is arranged in the wearable device and configured to detect the pregnancy related events, using the one or more physiological parameters measured by the sensor system of the wearable device.

10. The electronic system of claim 1 , wherein the processor is arranged in an external system, separated from the wearable device, the wearable device further comprises a communication transmitter configured to transmit the one or more physiological parameters measured by the sensor system of the wearable device to the external system, and the processor is configured to detect the pregnancy related events using the one or more physiological parameters received from the wearable device.

11. A method of detecting a pregnancy related events of a female human, the pregnancy related events consisting at least one of: ovulation, conception, or miscarriage, the method consisting of:

receiving in a processor from a sensor system of a wearable device one or more physiological parameters of the female human;

receiving in the processor from the female human an entry indicating a time of an actual menses of a first cycle;

determining, by the processor, time windows, for analyzing the one or more physiological parameters of the female human, using the time of the actual menses;

detecting the pregnancy related events by the processor comparing first physiological parameters of the female human with second physiological parameters of the female human, wherein the first physiological parameters are determined and recorded for a first one of the time windows and the second physiological parameters are determined and recorded for a second one of the time windows; and

indicating, by the processor, to the female human the pregnancy related events when the comparison of the first physiological parameters and the second physiological parameters meets defined detection criteria, and wherein the processor is configured to:

detect occurrence of the conception and to indicate to the female human a pregnancy status when a first set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a second final phase of a second cycle, has a higher value than the first set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows in a first final phase of a first cycle, by a defined threshold value, the first set of the first and the second physiological parameters of the female human including at least one of: a breathing rate of the female human, a heart rate of the female human, or a skin temperature of the female human, and wherein the processor is configured to set a starting time of the first one of the time windows in the first final phase of the first cycle to ten days after the ovulation in the first cycle, and to set a starting time of the second one of the time windows in the second final phase of the second cycle to ten days after the ovulation in the second cycle,

detect the miscarriage and to indicate to the female human the miscarriage when a third set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows, after the detection of the occurrence of the conception, shows a decreasing value by the defined threshold value from the third set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows preceding the second one of the time windows, the third set of the first and the second physiological parameters of the female human including at least one of: the heart rate of the female human or the skin temperature of the female human, and

detect an ovulatory cycle and to indicate to the female human the ovulatory cycle when a fourth set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a current final phase of a current cycle, shows a variation to the first physiological parameters, determined and recorded in the current cycle for the first one of the time windows preceding the second one of the time windows in the current final phase of the current cycle, which the variation is greater by the defined threshold value than the variation expected for an anovulatory cycle, the fourth set of the first and the second physiological parameters of the female human including at least one of: the heart rate of the female human, a standard deviation of beat to beat of a heart rate variability, a heart rate variability ratio, a heart rate variability parameter, or the skin temperature of the female human.

12. A computer program product consisting of a non-transitory computer readable medium having stored thereon computer program code configured to control one or more processors of a computerized system, such that the computerized system performs steps of:

receiving from a sensor system of a wearable device one or more physiological parameters of a female human;

receiving from the female human an entry indicating a time of an actual menses of a first cycle;

determining time windows, for analyzing the one or more physiological parameters of the female human, using the time of the actual menses;

detecting a pregnancy related events by the one or more processors comparing first physiological parameters of the female human with second physiological parameters of the female human, wherein the first physiological parameters are determined and recorded for a first one of the time windows and the second physiological parameters are determined and recorded for a second one of the time windows; and

indicating, by the one or more processors, to the female human the pregnancy related events when the comparison of the first physiological parameters and the second physiological parameters meets defined detection criteria, and wherein the one or more processors is configured to:

detect occurrence of a conception and to indicate to the female human a pregnancy status when a first set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a second final phase of a second cycle, has a higher value than the first set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows in a first final phase of a first cycle, by a defined threshold value, the first set of the first and the second physiological parameters of the female human including at least one of: a breathing rate of the female human, a heart rate of the female human, or a skin temperature of the female human, and wherein the one or more processors is configured to set a starting time of the first one of the time windows in the first final phase of the first cycle to ten days after ovulation in the first cycle, and to set a starting time of the second one of the time windows in the second final phase of the second cycle to ten days after the ovulation in the second cycle,

detect a miscarriage and to indicate to the female human the miscarriage when a third set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows, after the detection of the occurrence of the conception, shows a decreasing value by the defined threshold value from the third set of the first physiological parameters of the female human, determined and recorded in the first one of the time windows preceding the second one of the time windows, the third set of the first and the second physiological parameters of the female human including at least one of: the heart rate of the female human or the skin temperature of the female human, and

detect an ovulatory cycle and to indicate to the female human the ovulatory cycle when a fourth set of the second physiological parameters of the female human, determined and recorded in the second one of the time windows in a current final phase of a current cycle, shows a variation to the first physiological parameters, determined and recorded in the current cycle for the first one of the time windows preceding the second one of the time windows in the current final phase of the current cycle, which the variation is greater by the defined threshold value than the variation expected for an anovulatory cycle, the fourth set of the first and the second physiological parameters of the female human including at least one of: the heart rate of the female human, a standard deviation of beat to beat of a heart rate variability, a heart rate variability ratio, a heart rate variability parameter, or the skin temperature of the female human.

Assignments (4)
SECURITY INTEREST Recorded Oct 3, 2022
From: FEMTEC HEALTH, INC.; BIRCHBOX, INC.; MIRA AI, LLC; NUTRIMEDY, LLC; AVA WOMAN, LLC; AVA SCIENCES-FMTC, GMBH
To: LONGMONT CAPITAL, LTD.
Reel/Frame 061288/0935 →
ACTION BY WRITTEN CONSENT OF THE BOARD OF DIRECTORS IN LIEU OF A SPECIAL MEETING Recorded Jul 14, 2022
From: AVA SCIENCES-FMTC, GMBH; AVA WOMAN, LLC
To: FEMTEC HEALTH, INC.
Reel/Frame 060653/0815 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 14, 2022
From: AVA AG; AVA SCIENCE, INC.
To: AVA SCIENCES-FMTC, LLC; AVA WOMAN, LLC
Reel/Frame 060665/0885 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 7, 2021
From: STEIN, PETER
To: AVA AG
Reel/Frame 054849/0540 →
Priority Claims (1)
CH 01157/17 · Sep 20, 2017 · national
Continuity (1)
Related Publication 20200222032A1 · Jul 16, 2020
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