CN-121971104-A - Fetal heart monitoring sensing device, manufacturing method and fetal heart monitoring method

CN121971104ACN 121971104 ACN121971104 ACN 121971104ACN-121971104-A

Abstract

The invention provides a fetal heart monitoring sensing device, a manufacturing method and a fetal heart monitoring method, which comprise a flexible substrate, a central control unit, a conductive connecting structure and a plurality of fetal heart sensing subunits, wherein each fetal heart sensing subunit is electrically connected with the central control unit through the conductive connecting structure, each fetal heart sensing subunit comprises a semi-closed acoustic cavity base, an acoustic sensing module used for collecting fetal heart sound signals, an acoustic cavity and a pickup unit, an annular fetal heart electrode module used for collecting fetal heart sound signals, an insulating isolation structure is coaxially arranged around the pickup unit, is positioned between the annular fetal heart electrode module of the pickup unit, an elastic vibration isolation structure is arranged between the annular fetal heart electrode and the side wall of the acoustic cavity base, has lower hardness than the acoustic sensing module and the annular fetal heart electrode module, and the central control unit is used for acquiring the fetal heart sound signals and the fetal heart sound signals corresponding to each radiation area and calculating the values of uterine contraction indexes according to the acoustic signals and the fetal heart sound signals.

Inventors

ZHANG LING
LIU YANHAO
LIU FULONG
LIU YUAN
Ma Guanyong

Assignees

浙江爱客智能科技有限责任公司

Dates

Publication Date: 20260505
Application Date: 20260407

Claims (10)

1. A fetal heart monitoring sensing device, comprising: The flexible substrate comprises a central area, an arm-shaped connecting area and a plurality of radiation areas connected with the central area through the arm-shaped connecting area; the central control unit is arranged in the central area; the conductive connection structure is arranged in the arm-shaped connection area; The tire core sensing subunits are respectively arranged on the radiation areas and are electrically connected with the central control unit through the conductive connection structure, and each tire core sensing subunit comprises: The acoustic sensing module comprises a semi-closed acoustic cavity base and a pickup unit, wherein the pickup unit is arranged on the inner bottom surface of the semi-closed acoustic cavity base; the annular fetal heart electrode module is coaxially arranged around the central shaft of the pickup unit, so that the fetal heart sensing subunit performs co-location acquisition of the fetal heart sound signal and the fetal heart signal; the insulating isolation structure is positioned between the annular fetal heart electrode modules of the pickup unit; The elastic vibration isolation structure is arranged between the annular fetal heart electrode and the side wall of the semi-closed acoustic cavity base, and the hardness of the elastic vibration isolation structure is lower than that of the acoustic cavity base and the annular fetal heart electrode module; The central control unit is used for acquiring the corresponding fetal heart sound signals and the fetal heart sound signals in each radiation area and calculating the values of the uterine contraction indexes by utilizing the fetal heart sound signals and the fetal heart sound signals in each group.
2. A fetal heart monitoring sensor as set forth in claim 1 wherein, The elastic vibration isolation structure is an annular elastic vibration isolation structure; the thicknesses of the pickup unit, the insulating isolation structure, the annular fetal heart electrode module and the elastic vibration isolation structure are reduced in a step manner from the center to the periphery along the radial direction.
3. A fetal heart monitoring sensor as set forth in claim 2 wherein, The flexible substrate is a star-shaped flexible substrate, and the radiation areas are arranged in a star-shaped array around the central area, so that after manufacturing is completed, the fetal heart sensing subunits are arranged in a shape array around the central control unit.
4. A fetal heart monitoring sensor as set forth in claim 3 wherein, The number of the tire core sensing subunits is 4-8.
5. A fetal heart monitoring sensor as set forth in claim 4 wherein, The arm-shaped connecting area is provided with a plurality of connecting points of the fetal heart sensing subunit, the fetal heart sensing subunit is detachably connected to the corresponding connecting points, and each connecting point is adapted to the fetal heart position of different gestational weeks.
6. A fetal heart monitoring sensor as set forth in claim 5 wherein, The flexible substrate comprises a radiation area, at least two tire core sensing subunits, a tire core sensing subunit and a plurality of tire core sensing subunits, wherein the radiation area is connected with the central area through at least seven arm-shaped connection areas; The central control unit is used for distinguishing different fetal heart sounds according to the relative amplitude and the time sequence characteristic of the acquired detection signals of each fetal heart sensing subunit so as to perform multi-fetal monitoring, wherein the detection signals comprise fetal heart electrical signals and fetal heart sound signals.
7. The fetal heart monitoring sensor apparatus of claim 6 further comprising: The tyre core sensing sub-units are respectively provided with a temperature sensing module and a pressure sensing module, wherein the temperature sensing modules are used for detecting local skin temperature; The central control unit is used for regularly collecting the local skin temperature and the contact pressure, and evaluating the bonding quality according to the bonding threshold value of the local skin temperature and the contact pressure and the bonding threshold value of the contact pressure and the temperature fluctuation threshold value; when the contact pressure is lower than the contact pressure laminating threshold and the temperature fluctuation degree is greater than the temperature fluctuation threshold, judging that the lamination of the tire core sensing subunit is poor, otherwise judging that the lamination meets the monitoring requirement.
8. A method of manufacturing a fetal heart monitoring sensor apparatus for use in preparing a monitoring sensor apparatus as claimed in any one of claims 1 to 7, the method comprising: Each radiation area of the flexible substrate forms a semi-closed acoustic cavity base for bearing a fetal heart sensing subunit, and an acoustic cavity is formed in the semi-closed acoustic cavity base; forming a pickup unit at a center position of the semi-closed acoustic cavity base; forming an annular fetal heart electrode module on the semi-closed acoustic cavity base by using a coaxial positioning process with a central shaft of the pickup unit as a reference, and reserving an insulating area between the pickup unit and the annular fetal heart electrode module; Forming an insulating isolation structure in the insulating region; An elastic vibration isolation structure is formed between the annular fetal heart electrode module and the semi-closed acoustic cavity base, wherein the hardness of the elastic vibration isolation structure is smaller than that of the acoustic cavity base and the annular fetal heart electrode module; And connecting each fetal heart sensing subunit with a conductive connecting structure, installing the conductive connecting structure on an arm-shaped connecting area of the flexible substrate, and installing the central control unit on a central area of the flexible substrate.
9. A fetal heart monitoring method applied to a fetal heart monitoring sensing device as claimed in any one of claims 1 to 7, the monitoring method comprising: The acoustic sensing module and the annular fetal heart electrode module of each fetal heart sensing subunit respectively collect the fetal heart sound signals and the fetal heart electrical signals; the central control unit acquires corresponding fetal heart sound signals and fetal heart electrical signals in each radiation area; And calculating the value of the uterine contraction index by using each group of fetal heart sound signals and fetal heart electric signals.
10. A method for fetal heart monitoring as set forth in claim 9 wherein, Calculating the value of the uterine contraction index by using each group of fetal heart sound signals and fetal heart electric signals, wherein the method specifically comprises the following steps of: calculating signal quality indexes of each group of fetal heart sound signals and fetal heart sound signals, and carrying out channel selection or weighted fusion to obtain each group of steady fetal heart sound signals and steady fetal heart sound signals; Performing time sequence alignment on each group of steady fetal heart sound signals and steady fetal heart sound signals to obtain each group of preprocessed fetal heart sound signals and fetal heart sound signals; And calculating the value of the uterine contraction index by utilizing the preprocessed fetal heart sound signals and the fetal heart electrical signals of each group.

Description

Fetal heart monitoring sensing device, manufacturing method and fetal heart monitoring method Technical Field The invention relates to the field of wearable sensing equipment, in particular to a fetal heart monitoring sensing device, a manufacturing method and a fetal heart monitoring method. Background Perinatal fetal monitoring currently relies mainly on electronic fetal heart monitoring (cardiotocography, CTG), which acquires fetal heart rate by ultrasound doppler and performs comprehensive assessment in combination with uterine contraction monitoring. CTG, although widely used, has the problem of difficulty in continuous monitoring at home for a long period of time, that traditional CTG relies on large-scale equipment in hospitals, requires professional operation, and is not suitable for continuous monitoring of pregnant women in home environment for a long time at low cost and without wound. The interpretation consistency is poor, the false positive rate is high, CTG graphics are greatly influenced by the experience of operators, the interpretation consistency among different doctors is poor, and excessive false positive alarms are easy to generate. In existing non-invasive fetal heart monitoring schemes, there are ways to collect fetal heart sounds (fetalphonocardiography, fPCG) or fetal heart sounds (fetalelectrocardiography, fECG) based on the abdominal wall in addition to ultrasound Doppler. In recent years, non-invasive fetal heart sounds (fPCG) and fetal heart sounds (fECG) are considered to be important supplements to CTG. Fetal heart sounds are passive acoustic signals, are safe, non-radiative and low in cost, can reflect mechanical activities (S1/S2, noise and the like), and fetal heart electricity provides a time sequence 'gold standard' R peak of heart electric activity. However, the existing sensor scheme based on fPCG or fECG still has the obvious defects of single-point arrangement of the sensors, weak capability of resisting the change of the fetal position, sensitive fetal position change, easy failure of a one-point probe, frequent repeated movement of the traditional single-point ultrasonic probe for searching signals and poor user experience. Most fPCG/fECG acquisition devices adopt single-point or small-point placement, and when the fetal position is shifted, the fetal back is turned or the body position of the pregnant woman is changed, the fluctuation of the signal amplitude is obvious, and the signal interruption is easy to occur. To reduce the wearing complexity, some schemes employ a small number of point locations (e.g., single/dual/three point sensor arrangements), or form differential measurement channels with a small number of electrodes. The common characteristics of the scheme are that the number of the sensors is small, the coverage range is limited, and the effective fetal heart sound signals are obtained by depending on single points or few points. Therefore, in the monitoring equipment of the traditional single-point or small-amount point placement, when the fetal position is shifted, the fetal back is turned or the body position of the pregnant woman is changed, the signal amplitude is obvious, the signal interruption and the like are easy to occur, and the equipment is easy to fail in a continuous wearing scene. Therefore, developing a new fetal heart monitoring sensing device capable of effectively treating the influence of fetal position drift and wearing state change on the monitoring effect becomes a technical problem to be solved. Disclosure of Invention In order to solve the technical defects, the invention provides a fetal heart monitoring sensing device, a manufacturing method and a fetal heart monitoring method, and solves the problem that a single-point or small-point layout scheme based on the traditional monitoring sensing device fails in a continuous wearing scene in a structural aspect. The invention provides a fetal heart monitoring and sensing device, which comprises: The flexible substrate comprises a central area, an arm-shaped connecting area and a plurality of radiation areas connected with the central area through the arm-shaped connecting area; the central control unit is arranged in the central area; the conductive connection structure is arranged in the arm-shaped connection area; The tire core sensing subunits are respectively arranged on the radiation areas and are electrically connected with the central control unit through the conductive connection structure, and each tire core sensing subunit comprises: The acoustic sensing module comprises a semi-closed acoustic cavity base and a pickup unit, wherein the pickup unit is arranged on the inner bottom surface of the semi-closed acoustic cavity base; the annular fetal heart electrode module is coaxially arranged around the central shaft of the pickup unit, so that the fetal heart sensing subunit performs co-location acquisition of the fetal heart sound signal and the fetal heart signal; the