Positions, positioning methods and devices to measure the onset and progression of labor

Abstract

Positions, positioning methods and devices to measure the onset and progression of labor. The positions and devices can be utilized both / either at home or / and medical facilities and operated by professionals and non-professionals. The positions, devices and methods will allow accurate measurements, while the external, non-invasive application of the devices, improves comfort and privacy. Innovative probes and handles are tailored specifically for each position. All results and outcomes will appear on a display screen. The wearable and sitting devices can measure non-continuously, as well as continuously, a novel approach to this type of data. .

Description

[0001] POSITIONS, POSITIONING METHODS AND DEVICES TO MEASURE THE ONSET AND PROGRESSION OF LABOR

[0002] FIELD OF INVENTION

[0003] This invention is in the technical field of Obstetrics and Gynecology software and medical devices. More particularly, the present invention is in the field of assessing the onset of labor and labor progression, including different positions for measurements, measuring methods and technological bishop score assessments.

[0004] BACKGROUND OF THE INVENTION

[0005] During the late stages of pregnancy, changes in the connective tissue soften the cervix, indicating the initiation of labor. Physical transformations of the tissue include thinning (effacement) and opening (dilation) of the cervix. Generally, the onset of labor is defined as uterine contractions that bring about demonstrable effacement and dilation of the cervix. The indications of painful and frequent contractions accompanied by 3-4 centimeters or more of dilation is the most common method used in the United States and most western countries to admit pregnant women for labor. Cervical effacement, dilation and consistency as well as fetal positioning, and station are also used to determine the progression of active labor and can be a significant indicator for abnormalities. Currently, cervical effacement and dilatation measurements are mainly performed manually, during vaginal examination, in the hospital. Currently there are no positions, methods or devices to measure the onset of labor at home. The significant role of effacement and dilation in the process of labor emphasizes the importance of accurate and consistent measurements.

[0006] SUMMARY OF THE INVENTION

[0007] The present invention includes different positions, positioning methods and devices to indicate the onset of labor and labor progression in the hospital and outside a medical facility. The innovation includes four novel positions for such measurement, two innovative medical devices and two methods. The methods relate to self and professional operations. The positions include sitting, supine, standing and lateral recumbent. The innovative devices illustrate a wearable device and a sitting platform. An innovative probe is dedicated for each novel position. All devices include image processors, displaying screens and ultrasound elements.

[0008] BRIEF DESCRIPTION OF THE DRAWINGS

[0009] FIG. 1 is a schematic block diagram of an operation mode for self-use.

[0010] FIG. 2 is a schematic block diagram of an operation mode for non-self, professional or non-professional operator.

[0011] FIG. 3 shows measurement and operation in sitting position.

[0012] FIG. 4 presents measurement and operation in standing position.

[0013] FIG. 5 explains measurement and operation in supine self-test position.

[0014] FIG. 6 reveals measurement and operation in Left / right Lateral recumbent position.

[0015] FIG. 7 describes a wearable device to measure the onset and progression of labor for inside and outside medical facility use.

[0016] FIG. 8 illustrates a continuous monitoring device to measure the onset and progression of labor for inside and outside medical facility use.

[0017] FIG. 9 illustrates a hands- free sitting monitoring device 78 for continuous and or non- continuous measurements.

[0018] The following detailed description of embodiments of the invention refers to the accompanying drawings referred to above. Features shown in the figures are chosen for convenience or clarity of presentation and are not necessarily shown to scale. Wherever possible, the same reference numbers will be used throughout the drawings and the following description to refer to the same and like parts. DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

[0019] Fig.1 illustrates a schematic block diagram of an operation mode for self-use. It explains in details, the stages to reach the desired result from the self-operated device, beginning with selection of wanted location and position for measurement. Once position is selected, a correlating probe is selected from the kit. The device should be properly cleaned and handled, according to the instructions supplied. The probe is adhered externally to the perineum. The probe is moved by user in different locations until an indication from the device to the correct images are achieved. Data is acquired in the form of images and videos and analyzed. Feedback will be given online to the user, correcting and optimizing the data acquisition. Results regarding the onset and progression of labor will be presented to user and may also be sent to professional healthcare supplier or others, as desired by the user or required by regulations.

[0020] The schematic block diagram of Fig. 2 instructs a professional / non-professional ultrasound operator, other than the examinee, how to perform the measurement. The device should be properly cleaned and handled, according to the instructions supplied. The probe is adhered externally to the perineum. The probe is moved by user in different directions until indication from the device to the correct images are achieved. Data is acquired in the form of images and videos and analyzed.

[0021] Fig. 3 is a schematic representation of external female reproductive organs. The vaginal opening 10, internal 12 and external 14 labia, are parts of the Vulva 16, which needs to be exposed for the measurement. In addition, the Ultrasound probe is placed on the Perineum 18, located between the Vulva 16 and the Anus 20

[0022] Fig. 4 is referring to measurements performed in sitting position 22. If sitting position for self-use is selected by the user, the probe 24 will be adjusted in accordance. The user will sit on the edge of sitting equipment 26 (such as chair or sofa) comfortably and safely, while the external anatomical parts of the female reproductive system, such as the vulva 16 and perineum 18 are exposed. The probe 24 is placed on the perineum 18 and moved. The data acquired from the ultrasound receiver is transmitted to the image processor 28, where the data is processed and image or other feedback is displayed on the display screen 30. A measurement with innovative dedicated device to indicate the onset and progression of labor, in standing up position, is illustrated in fig. 5. When standing position for self-use is selected by the user, the probe 32 for standing position is also selected. The probe is composed of a transmitter 34, which generated pulsed echo in brief burst, a transducer 36, which converts electrical to acoustic signals and an innovative tailored handle 38 with adjusting lengths and shapes. The user will stand comfortably and safely with one leg leaning on a footstool 40 to open a gap between the legs and expose the perineum 18. The probe is adhered to the perineum 18, and rotated and moved, while data is collected. The data acquired from the ultrasound receiver is transmitted to the image processor 28, where the data is processed and image or other feedback is displayed on the display screen 30.

[0023] Fig. 6 illustrates a self-test supine position 42. Upon selecting the supine position for selftest, the suitable self-test supine probe 44 is utilized. The self-test supine probe 44 is attached to a dedicated handle 46, with the possibility to change length and shape. The self-test supine probe 44 also includes a transmitter 34, which generated pulsed echo in brief burst and a transducer 36, which converts electrical to acoustic signals. The data is transmitted to the receiver and is processed by the image processor 28. Images and or videos and or feedback is presented on the display screen 30.

[0024] Fig. 7 presents left / right lateral recumbent measuring position 48 for innovative device to indicate the onset and progression of labor. A left / right lateral recumbent dedicated probe 50 is used. The probe is composed of a transmitter 34, which generated pulsed echo in brief burst, a transducer 36, which converts electrical to acoustic signals and an innovative tailored handle 52, the handle may elongate, to different lengths and shapes. The ultrasound wavelengths are transmitted, while the left / right lateral recumbent dedicated probe 50 is in motion, until feedback from the display screen 30 indicates the optimal image is acquired. The image processor 28 and display screen 30 may operate on a user cell phone. The socket charger 54, designed specifically for the left / right lateral recumbent measuring position 48, permits comfort and finest user-interface experience.

[0025] The wearable device 56 presented in fig. 8 is composed of mechanical and electrical components embedded in tailored, adjustable fabric 58. The electrical components include ultrasonic circuit board 60 with a transmitter 34, transducer 36 and other electrical components. Such transducer may also be a capacitive micromachined ultrasonic transducer

[0026] 70 (the energy transduction is due to changes in capacitance). The circuit board 60 is embedded in acoustic couplant 62 such as gel. In addition, a track 64 along with a robotic arm 66 with an engine 68 allowing movement of the transmitter 34, to create optimal image. The signal omitted from the circuit board 60 is communicated through telecommunication system 72 to a data collector and processor 74. The results are utilized as data for a closed-system feedback 76, to acquire the optimal results for the indication of the onset of labor. The outcomes appear on the display screen 30. Measurements of the onset and progression of labor with the wearable device 56 may be digital or continuous tests.

[0027] Referring to the wearable device in Fig. 8, the medical device described in fig. 9 is a hands- free sitting monitoring device 78 for continuous and or non-continuous measurements. The device is composed of a sitting element 80, containing mechanical and electrical components. The electrical components include ultrasonic circuit board 60 with a transmitter 34, transducer 36 and other electrical components. Such transducer may also be a capacitive micromachined ultrasonic transducer 70. The circuit board 60 is embedded in acoustic couplant 62 such as gel. To perform a measurement, the sitting monitoring device 78 is placed on a sitting equipment 26 (such as chair), the user sits comfortably on the sitting monitoring device, as instructed, according to indications 82 on the device. To initiate measurement, the user presses a button on the phone application 84 particularly designed for the innovative device.

Claims

CLAIMS1. A system for externally measuring the onset and progression of labor in a pregnant subject, comprising:(a) a probe comprising an ultrasound transmitter and a transducer, the probe configured for external placement on the perineum of the subject;(b) an image processor in communication with the probe, configured to receive ultrasound data and generate diagnostic images;(c) a display device for presenting said images and associated labor progression data to a user; and(d) a positioning mechanism or configuration for enabling the use of said probe in at least one of: sitting, standing, supine, or lateral recumbent position, wherein the system is operable by the subject (self-use) and / or by a professional or non-professional operator.

2. The system of claim 1, wherein the probe includes a rotatable handle with adjustable length and ergonomic shape.

3. The system of any of claims 1-2, further comprising a set of interchangeable probes, each tailored for a corresponding user position.

4. The system of any of claims 1-3, wherein the image processor includes software configured to provide real-time visual or auditory feedback.

5. The system of any of claims 1-4, wherein the display device comprises a mobile device application operable on a smartphone or tablet.

6. The system of any of claims 1-5, wherein the ultrasound transmitter comprises a CMUT or piezoelectric transducer.

7. The system of any of claims 1-6, further comprising a wearable device configured to secure the probe to the perineum.

8. The system of claim 7, wherein the movement assembly comprises actuators, tracks, or motorized elements.

9. The system of any of claims 1-8, further comprising a sitting monitoring device comprising a platform with embedded probe.

10. The system of claim 9, configured for periodic or continuous measurements without manual intervention.

11. The system of any of claims 1-10, further comprising visual or tactile alignment aids integrated into the probe.

12. The system of any of claims 1-11, further comprising a wireless communication module to transmit data.

13. The system of any of claims 1-12, wherein the system computes a digital Bishop score.

14. The system of any of claims 1-13, wherein the system includes protective barriers or disposable sheaths.

15. The system of any of claims 1-14, comprising onboard or cloud-based data storage.

16. The system of any of claims 1-15, configured for use outside medical facilities, including home environments.

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