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WO2018134844A1 - Dispositif d'auscultation portable - Google Patents

Dispositif d'auscultation portable Download PDF

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Publication number
WO2018134844A1
WO2018134844A1 PCT/IN2018/050022 IN2018050022W WO2018134844A1 WO 2018134844 A1 WO2018134844 A1 WO 2018134844A1 IN 2018050022 W IN2018050022 W IN 2018050022W WO 2018134844 A1 WO2018134844 A1 WO 2018134844A1
Authority
WO
WIPO (PCT)
Prior art keywords
transducer
haptic feedback
auscultation device
portable
portable auscultation
Prior art date
Application number
PCT/IN2018/050022
Other languages
English (en)
Inventor
Balaji Teegala
Prashant Jha
Original Assignee
Brun Health Private Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Brun Health Private Limited filed Critical Brun Health Private Limited
Publication of WO2018134844A1 publication Critical patent/WO2018134844A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0011—Foetal or obstetric data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02411—Measuring pulse rate or heart rate of foetuses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02438—Measuring pulse rate or heart rate with portable devices, e.g. worn by the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Measuring devices for evaluating the respiratory organs
    • A61B5/0816—Measuring devices for examining respiratory frequency
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/344—Foetal cardiography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
    • A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
    • A61B5/4343—Pregnancy and labour monitoring, e.g. for labour onset detection
    • A61B5/4362—Assessing foetal parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6832—Means for maintaining contact with the body using adhesives
    • A61B5/6833—Adhesive patches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0406—Constructional details of apparatus specially shaped apparatus housings
    • A61B2560/0412—Low-profile patch shaped housings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219—Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/06—Arrangements of multiple sensors of different types
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/164—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted in or on a conformable substrate or carrier

Definitions

  • the present invention generally relates to devices and systems for observation of biological parameters. More particularly, the present invention relates to a portable auscultation device that provides haptic feedback.
  • the most easily identifiable and quantifiable parameter used by healthcare providers and pregnant families to judge fetal wellness during pregnancy is the fetal heart rate. This is currently measured using well -understood and clinically accepted technologies like Ultrasound and Electrocardiography. Feedback provided in expressing the auscultated fetal heart sounds and calculated fetal heart rate values is provided visually, by means of a display, and/or acoustically, by means of an audio speaker. This feedback either assures or alerts healthcare providers and pregnant families of their unborn child's condition. Most innovations in the fetal monitoring space have been to enable easy monitoring of the unborn child by healthcare providers and pregnant families through a plethora of designs and configurations that focus on ergonomics and aesthetics of use for monitoring. However, there has been little to no effort in establishing or improving the personal engagement and nurturing the emotional bond between the pregnant family and their unborn child through these devices.
  • US20160213349A1, US20160100817A1, US20100152620A1, US20160157717A1, and US20070255184A1 describe measurement of physiological parameters with haptic feedback.
  • these patent publications lack information about any method or means of isolation to isolate noise sources from the transducer from the haptic feedback.
  • a basic object of the present invention is to overcome the disadvantages and drawbacks of the known art.
  • An objective of this invention is to provide a portable auscultation device that can be easily used at home by a pregnant family. Another object of this invention is to provide a portable auscultation device that can provide realistic haptic feedback to the person holding or wearing the device.
  • Yet another object of the invention is to provide a portable auscultation device that can nurture the emotional bond between a pregnant family and their unborn child through haptic feedback without compromising on the quality of device function by incorporating isolation elements to isolate the feedback elements from the sensing elements.
  • Yet another object of the invention is to improve personal engagement by means of device connectivity with mobile computing devices, showcasing latest pertinent health information and enabling information sharing with family, friends and healthcare professionals.
  • the invention relates to a portable auscultation device that includes a device housing, and a transducer that captures a physiological signal indicative of a condition of a fetal heart and converts the physiological signal in an electrical signal.
  • the device further includes a processor that processes the electrical signal produced by the transducer.
  • the device includes a haptic feedback system disposed on the device housing that provides a haptic feedback to a user contacting the device housing based on the processed electrical signal.
  • the device includes an isolation component that isolates the haptic feedback system from the transducer.
  • the transducer is an ultrasonic transducer that captures fetal heart sounds.
  • the haptic feedback system includes a vibration motor or a piezo-film.
  • the isolation component is made of at least one of a vibration absorbing material and a flexible material.
  • the device includes at least one of an audio speaker for auditory feedback, and a visual display or light source e.g. LED, for visual feedback.
  • a visual display or light source e.g. LED
  • the haptic feedback system includes a haptic feedback surface, wherein the haptic feedback system modifies the surface properties, such as texture, dimensions, breathability, static charge, and compressibility of the haptic feedback surface.
  • the haptic feedback surface includes at least one of a shape memory material and an electro-active material.
  • the haptic feedback system includes a haptic feedback surface, wherein the haptic feedback system comprises surface charge modulation to give a sense of touch that is variable.
  • the processor processes the electrical signal produced by the transducer to perform at least one of a fetal heart rate calculation, baby kicks count, and a non-stress test.
  • the device includes at least one of a wired and a wireless connection circuit for data transmission and charging.
  • the device housing is shaped as a glove to be worn on a user's hand.
  • the invention also relates to a method of generating a haptic feedback signal using the portable auscultation device, the method including transmitting an ultrasonic signal from a transducer element of the portable auscultation device; receiving a reflected signal of the transmitted ultrasonic signal at the transducer; filtering the received signal for removing signal noise in an electrical circuit arrangement; calculating an observed quantity from the filtered signal in a processor; generating a haptic feedback based on the calculated observed quantity on a haptic feedback system; and isolating the transducer from the haptic feedback system to prevent any noise interference in the transducer signals.
  • FIGS. 1A, IB, and 1C illustrate a first embodiment of the portable auscultation device, wherein FIG 1A is a perspective view of the portable auscultation device, FIG. IB is an exploded view of the first embodiment of the portable auscultation device, and FIG. 1C is a schematic diagram of a circuit arrangement of the electrical components of the device 100.
  • FIG. 2 is a schematic diagram illustrating a method of providing haptic feedback through device 100.
  • FIGS. 3A and 3B illustrate a second embodiment of the portable auscultation device, wherein FIG. 3A illustrates a top region of the portable auscultation device, and FIG. 3B illustrates a bottom region of the second embodiment of the portable auscultation device.
  • FIGS 4A and 4B illustrate the use of the portable auscultation device, wherein FIG. 4A illustrates use of the embodiment of FIGS. 1A and IB, and FIG. 4B illustrates use of the embodiment of FIGS. 3A and 3B.
  • FIG 5A and 5B illustrate a third embodiment of the portable auscultation device, wherein FIG 5A is a perspective view of the portable auscultation device and FIG. 5B is an exploded view of the third embodiment of the portable auscultation device.
  • FIGS 6 A and 6B illustrate a fourth embodiment of the portable auscultation device, wherein FIG 6A illustrates the portable auscultation device and FIG. 6B illustrates the portable auscultation device with a belt.
  • the invention relates to devices used for measuring biological parameters and the feedback they provide in expressing device function, measured metric and their derivatives.
  • a biological parameter is fetal heart rate.
  • the current invention is a feedback device comprising a surface of an embodiment that is modulated to represent temporal variations in biological parameters. When applied to fetal monitoring, an embodiment or a part of it capture the fetal heart sounds and convey them or their derivatives signals through a feedback method.
  • the current invention modulates the one or more of the embodiments surface's properties and perceptions including but not limited to dimensions, texture, breathability and compressibility as a means of providing feedback to the user and thus provides a very unique way of establishing an emotional connect between the user and the measured parameter, like the unborn child's heart sounds or its derivatives.
  • the device essentially includes a device housing and a transducer that captures a physiological signal indicative of a condition of a fetal heart and converts the physiological signal in an electrical signal.
  • the device also includes a processor that processes the electrical signal produced by the transducer.
  • the device further includes a haptic feedback system disposed on the device housing that provides a haptic feedback to a user contacting the device housing based on the processed electrical signal, wherein, the haptic feedback system includes an isolation component that isolates the haptic feedback system from the transducer.
  • One embodiment comprises a hand held probe that is held in place over the abdomen to capture the fetal heart sounds.
  • the heart rate is conveyed to the user through vibrations on the surface of the probe at the same or proportional rate with accelerations and decelerations in heart rate directly impacting the periodicity of vibrations felt on the surface of the probe.
  • Another embodiment comprises a glove worn on the hand.
  • the transducer elements embedded in the anterior of the glove pick the fetal heart sounds from the surface of the abdomen when the glove is worn and placed on the abdomen.
  • the heart rate is conveyed to the user through compression and expansion of a layer of the glove or vibrations on the surface of the palm at the same or proportional rate with accelerations and decelerations in heart rate directly impacting the periodicity of vibrations felt on the surface of the probe.
  • Yet another embodiment is a belt worn device that includes a groove to attach the device to a belt.
  • All embodiments isolate vibrations from the transducers/sensors capturing the fetal heart sounds using a damping material that separates the transducer structure from the feedback structure in the physical design.
  • the embodiments comprise and input for counting baby kicks during auscultations. This information is synced with the fetal heart auscultations to create a report for a non-stress test. The primary goal of the test is to measure the heart rate of the fetus in response to its own movements. Healthy babies will respond with an increased heart rate during times of movement and the heart rate will decrease at rest.
  • FIG. 1A, IB, and 1C illustrate a first embodiment of a portable auscultation device 100 as a hand-held device, wherein FIG 1A is a perspective view of the device 100, FIG. IB is an exploded view of the device 100, and FIG. 1C is a schematic diagram of a circuit arrangement of the electrical components of the device 100.
  • FIG. 1A is a perspective view of the device 100
  • FIG. IB is an exploded view of the device 100
  • FIG. 1C is a schematic diagram of a circuit arrangement of the electrical components of the device 100.
  • the device 100 includes a device housing 102, a transducer 104 that captures a physiological signal indicative of a condition of a fetal heart and converts the physiological signal in an electrical signal, a processor 108 that processes the electrical signal produced by the transducer 104, and a haptic feedback system 110 disposed on the device housing 102 that provides a haptic feedback to a user contacting the device housing 102 based on the processed electrical signal, wherein, the haptic feedback system 110 includes an isolation component 112 that isolates the haptic feedback system 110 from the transducer 104.
  • the portable auscultation device 100 may include additional components such as a display 114, a wired or wireless charging and/or data port 116, and a switch 118.
  • the device housing 102 includes a rigid frame 120 and an isolation component base frame 122 that are attached together to form the base structure of the device housing 102.
  • the rigid frame 120 and the isolation component base frame 122 join with each other in a direction perpendicular to the longitudinal axis of the device housing 102 such that the device housing 102 has a recessed portion over the isolation component base frame 122 to accommodate the isolation component 112.
  • the isolation component 112 has a number of protrusions (not shown) at the surface facing towards isolation component base frame 122 and the isolation component base frame 122 has a number of corresponding slots (not shown) for attachment of the protrusions on to the slots, such that upon attachment an air gap is formed between the isolation component base frame 122 and isolation component 112.
  • the rigid frame 120, the isolation component base frame 122, and the isolation component 112 upon attachment form a substantially symmetrical cylindrical or conical structure along the length of the device 100.
  • the assembly of the rigid frame 120, isolation component base frame 122, and the isolation component 112 is dimensioned to be easily graspable in a human hand.
  • the assembly of the rigid frame 120, isolation component base frame 122, and the isolation component 112 has an outer distal end diameter in the range of 2 cm and 6 cm, an outer mid-region diameter in the range of 1.5 cm and 5 cm, and an outer proximal end diameter in the range of 2 cm and 5 cm.
  • the assembly of the rigid frame 120, isolation component base frame 122, and the isolation component 112 has a length that facilitates ergonomic handling of the device 100 in a user's hand.
  • the assembly of the rigid frame 120, isolation component base frame 122, and the isolation component 112 has a length ranging between 4 cm and 12 cm.
  • the rigid frame 120 is made of a material such as metal, plastic, glass, wood, or ceramic. In some, embodiments, the rigid frame 120 is made of scratch resistant highly reflective glass or ceramic material for cosmetic appeal. In some other embodiments, the rigid frame 120 is made of a high-tensile strength plastics or metals for durability. In some other embodiments, the rigid frame 120 is made of a light weight plastic, aluminum or wood for reducing the overall weight of the portable auscultation device. The rigid frame 120 is made of a sufficient thickness to impart strength to the material used such that that it does not bend, break, or flex upon gripping by a human or upon accidentally falling to the ground from the average height of a human being. In some embodiments, the thickness of the rigid frame 120 ranges between 0.8 mm and 2 mm.
  • the material of the rigid frame 120 can have any type of a hatched, embossed, or engraved textured pattern.
  • the rigid frame 120 material has a textured surface for facilitating the griping of the device 100.
  • the rigid frame 120 can have a smooth surface.
  • the surface of the rigid frame 120 has a sleeve or covering of materials such as cloth, velvet, leather, suede etc.
  • materials such as cloth, velvet, leather, suede etc.
  • the isolation component base frame 122 is made of a durable stiff material such as stiff plastics or metals.
  • the isolation component base frame 122 is made of a sheet of metal, such as steel or aluminum with sufficient thickness to impart enough stiffness to the isolation component base frame 122 such that it does not bend, break, or flex upon gripping by a human or upon accidentally falling to the ground from the average height of a human being.
  • the thickness of the isolation component base frame 122 ranges between 0.8 mm and 2 mm.
  • isolation component base frame 122 is made of vibration absorbing stiff plastic material such as PTFE, PU, Nylon-6, etc. In some other embodiments, the isolation component base frame 122 is made of any other type of stiff vibration absorption material such as foam, or a metal or polymer lattice structure. A person of ordinary skill in the art can identify a number of materials that can be used to make the isolation component base frame 122.
  • the isolation component 112 is made of a pliable vibration absorbing material such as soft rubbers, polymers, fabrics, leathers, foams, or gels. In some embodiments, the isolation component 112 is made of a soft and durable material with high vibration absorption properties, for example, rubber.
  • the material of the isolation component 112 can have any type of a hatched, embossed, or engraved textured pattern.
  • the isolation component 112 has a smooth surface.
  • the surface of the isolation component 112 has a sleeve or covering of materials such as cloth, velvet, leather, suede, etc.
  • the transducer 104 is a piezoelectric ultrasound transducer. In some embodiments, the transducer 104 is dimensioned to be affixed in a transducer housing 106. In some embodiments, the transducer 104 is an off-the shelf ultrasound transducer available in the market. For example, the ultrasound transducer is a Piezo-ceramic actuator available from Ceramtech GmbH.
  • the transducer housing 106 is dimensioned to tightly fit into or onto the distal end of the device housing 102.
  • the transducer housing 106 has a diameter substantially equal to the diameter of the distal end of the device housing 102.
  • the transducer housing 106 may include protrusions or other features that allows for attachment of the transducer housing 106 to the distal end of the device housing 102 and the transducer 104.
  • the transducer housing 106 is be made of a metal or polymer material that offers minimum resistance to the ultrasounds passing through the transducer housing 106. Further, in some embodiments, the transducer housing 106 is made of materials that are smooth and biocompatible, such that the transducer housing 106 upon contact with the abdominal skin of a pregnant woman does not cause any adverse reaction, abrasions, or injury of any kind to the pregnant woman.
  • the transducer housing 106 is made of a sheet of metal, such as steel or aluminum or a durable plastic such as Polycarbonate (PC) or Acrylonitrile butadiene styrene (ABS) or its combination with sufficient thickness to impart enough stiffness to the transducer housing 106 such that it does not bend, break, or flex upon accidentally falling to the ground from the average height of a human being.
  • the thickness of the transducer housing 106 ranges between 0.6 mm and 2 mm.
  • the processor 108 is a general microprocessor or microcontroller that can perform the functions of the device 100 as described herein.
  • the processor 108 can be an off- the-shelf processor available in the market.
  • the processor is a Microcontroller available from Atmel Corporation.
  • the processor 108 is mounted on a printed circuit board 124 positioned parallel to the longitudinal axis of the device housing 102 sandwiched between the rigid frame 120 and the isolation component base frame 122.
  • the printed circuit board 124 can be of any shape and size that can be accommodated within the device housing 102 and includes structural features for attachment of the printed circuit board 124 to the device housing 102.
  • a battery frame 126 holding a battery 128 is positioned parallel to the longitudinal axis of the device housing 102 sandwiched between the printed circuit board 124 and the isolation component base frame 122.
  • the battery frame 126 is dimensioned and includes structural features to hold the battery 128 tightly within the device housing 102.
  • the battery 128 is a non-rechargeable battery or a primary cell, for example, an alkaline battery, aluminum-ion battery, aluminum-air battery, etc.
  • the battery 128 is a rechargeable battery or a secondary cell such as a nickel cadmium battery, nickel-metal hydride battery, lithium ion battery, or a lithium polymer battery.
  • the battery is dimensioned to be held within the battery frame 126 in the device housing 102.
  • the battery 128 is an off- the shelf battery available in the market.
  • the battery 128 is a Rechangeable Litium ion battery available from Renesas Electronics Corporation.
  • the haptic feedback system 110 can be any system that modifies the surface properties, such as texture, dimensions, breathability, static charge and compressibility of device housing 102 to provide haptic feedback to a user.
  • the haptic feedback system 110 changes the texture of the device housing 102 from a smooth surface to a grainy surface.
  • the haptic feedback system 110 includes an air pump connected to a breathable fabric that changes pumps air in and out of the fabric to change its breathability.
  • the haptic feedback system 110 includes an electro active material that changes its compressibility upon electrical stimulation.
  • the haptic feedback system 110 provides vibrational feedback to the user and includes a vibration motor 130 attached to the end of the isolation component 112 facing the isolation component base frame 122 and is positioned in the air gap between the isolation component 112 and the isolation component base frame 122, such that the vibration motor 130 only contacts the isolation component 112.
  • the vibration motor 130 is attached to the isolation component 112 using one or more attachment means, such as adhesives and/or structural features on the surface of the isolation component 112 or both.
  • the vibration motor 130 is an off-the shelf vibration motor available in the market.
  • the vibration motor 130 is a Vibration trasnducer available from Precision Microdrives Ltd.
  • a speaker 132 attached to the end of the isolation component 112 facing the isolation component base frame 122 and is positioned in the air gap between the isolation component 112 and the isolation component base frame 122, such that the speaker 132 only contacts the isolation component 112.
  • the speaker 132 is attached to the isolation component 112 using one or more attachment means, such as adhesives and/or structural features on the surface of the isolation component 112.
  • the speaker 132 is an off-the shelf speaker available in the market.
  • the speaker 132 is a generic 1 Watt speaker available from PUI Audio Inc.
  • the haptic feedback system 110 includes both the vibration motor 130 and the speaker 132 configured attached to the end of the isolation component 112 facing the isolation component base frame 122 and are positioned in the air gap between the isolation component 112 and the isolation component base frame 122, such that the vibration motor 130 and the speaker 132 only contacts the isolation component 112.
  • the display 114 is mounted on a display frame 134 positioned on the proximal end of the device housing 102.
  • the display 114 is covered by a display pane 136 and a cap 138.
  • the display 114, display frame 134, display pane 136, and cap 138 are dimensioned and include structural features to attach to the proximal end of the device housing 102.
  • the display 114 can be any of an LCD, LED, OLED, or any other type of display that a person of ordinary skill in the art can identify to be used in the device 100.
  • the display 114 can display any data related to the fetal heart observation carried out by the device 100 such as fetal heart rate, baby kicks, fetal ECG, etc.
  • the display 114 is an off-the shelf display available in the market.
  • the display 114 is a Color LED dispaly available from CrystalFontz Inc.
  • the display could also be one or more LED lights for indicating that the device is on and functioning.
  • the display pane 136 is a clear transparent pane made of glass, plastic, crystal, or any other material that is shaped to cover the display 114 and protect the display 114 from external environment and wear and tear.
  • the display frame 134 and cap 138 are metal or plastic parts dimensioned and having structural features to tightly hold the display 114 and the display pane 136 at the proximal end of the device housing 102.
  • the display frame 134 and the cap 138 have a substantially circular shape with a diameter substantially similar to the diameter of the proximal end of the device housing 102.
  • the display frame 134 and cap 138 are made of sheet metal, such as steel or aluminum or a durable plastic such as Polycarbonate (PC) or Acrylonitrile butadiene styrene (ABS) or its combination with sufficient thickness to impart enough stiffness to the display frame 134 and cap 138 such that they do not bend, break, or flex upon accidentally falling to the ground from the average height of a human being.
  • the thickness of the display frame 134 ranges between 0.8 mm and 2 mm and the thickness of the cap 138 between ranges 0.8 mm and 2 mm.
  • the wired charging and/or data port 116 can be a type of USB port, a serial, a 3.5 mm audio port, or any other kind of ports known in the art for data transmission and charging, the wired charging and/or data port 116 can be used to charge the battery 128 in embodiments where the battery 128 is rechargeable.
  • the charging and/or data port 116 can also be used to connect to a computing device, such as a computer or a mobile phone to transfer data and receive programming instructions for the processor 108.
  • the wired charging and/or data port 116 is mounted on a socket 140 between the rigid frame 120 and the isolation component base frame 122. In some other embodiments, the socket 140 is placed on the rigid frame only.
  • the device 100 may not have the wired charging and/or data port 116 and instead rely on wireless charging and data communication for charging the battery 128 and communicating with an external computing device.
  • wireless technologies and standards are known in the art and available in the market that can be used for implementing such embodiments.
  • wireless charging for example, Qi, A4WP, and Powermat
  • wireless data transfer Bluetooth, Wi-Fi, LTE, etc.
  • the switch 118 is an on/off switch for the device 100.
  • the switch 118 can be any type of switch known in the art, such as a push switch, toggle switch, rotary switch, slide switch, etc. In some embodiments, the switch 118 can be touch sensitive panel or a finger print sensor.
  • the switch 118 can be used to turn the device 100 on and off by a user.
  • the switch 118 is mounted on a socket 142.
  • the socket 142 can be positioned anywhere on the rigid frame 120 or between the rigid frame 120 and the isolation component base frame 122 based on ergonomics or user comfort.
  • the switch 118 has a vibration motor to provide haptic feedback to the user when the device is turned on.
  • the PCB 124 includes a data storage (not shown) for storing data.
  • the processor 108 stores information recorded over a period of time in the data storage for future use or for comparing present and past data to analyze long term fetal health.
  • the data storage can be a memory card or any other form of data storage device known in the art that can be accommodated within the device housing 102 along with the other components. Further, the data stored in the data storage can be transmitted to a more capable computing device such as a laptop, computer, or a mobile phone, via the wired charging and/or data port 116 or any wireless means.
  • the PCB 124 includes a power management circuit (not shown) to transfer power from the battery 128 to the electrical/electronic components within the device 100, i.e. the processor 108, transducer 104, display 114, wired charging and/or data port 116, switch 118, vibration motor 130, and the speaker 132.
  • the power management circuit distributes and regulates power from the battery 128 to the electrical components, when the switch 118 is turned on and restricts power distribution when the switch 118 is turned off.
  • a person of ordinary skill in the art can implement a number of known power management circuits.
  • the structural components such as the rigid frame 120, transducer housing 106, isolation component base frame 122, display frame 134, display pane 136, cap 138, battery frame 126, and PCB 124 can be made by a number of manufacturing methods known in the art.
  • parts made of sheet metal can be made by processes such as cutting, blanking, bending, drawing, curling, hemming, seaming, hydroforming, perforating, punching, rolling, stamping, 3D Printing etc.
  • parts made of plastics can be made by processes such as injection molding, 3D printing, thermosetting, etc.
  • the structural components such as the rigid frame 120, transducer housing 106, isolation component base frame 122, display frame 134, display pane 136, cap 138, battery frame 126, and PCB 124, are joined together with any suitable mechanical or chemical joining means known in the art, such as, rivets, screws, friction fit, adhesives etc.
  • the electrical components, transducer 104, processor 108, display 114, wired charging and/or data port 116, switch 118, battery 128, vibration motor 130, and the speaker 132 are connected to the PCB 124 can be custom made or from processes known in the art, or off-the-shelf parts can be customized or used for making the device 100. Further, the electrical components, transducer 104, processor 108, display 114, wired charging and/or data port 116, switch 118, battery 128, vibration motor 130, and the speaker 132 are connected to the PCB 124 via suitable electrical connection means, such as conductor wires, leads, or conductive traces.
  • the PCB 124 includes a circuit, which enables the operation of the device 100.
  • the processor 108 and the PCB 124 are connected to all the peripheral components, i.e., transducer 104, display 114, wired charging and/or data port 116, switch 118, battery 128, vibration motor 130, and the speaker 132.
  • the processor 108 signals the transducer 104 to start emitting ultrasonic transmissions and receiving the reflections of the said ultrasonic transmissions.
  • the ultrasonic transmissions are in the range of 1 MHz to 5 MHz. The reflections of the ultrasonic transmissions are then picked up by the transducer and transmitted back to the processor 108.
  • the processor 108 processes and filters the reflections or reflected signals to reduce noise and extracts fetal heart auscultation signals, and/or baby kick signals.
  • Many hardware and software signal filters are known in the art.
  • a hardware or software band pass filter can be implemented to filer fetal heart auscultation signals in the frequency range of 50 Hz to 500 Hz.
  • the processor 108 then calculates Doppler shift in the filtered received signals to calculate fetal heart rate and/or baby kicks.
  • the processor 108 can further perform a Non-stress test on the basis of the calculated information.
  • the processor 108 then sends the calculated information to the peripheral output devices, i.e. the display 114, vibration motor 130, and speaker 132 for providing feedback to the user.
  • the display 114 can display the fetal heart rate, baby kick count, results of the non-stress test, while the audio speaker 132 can provide an auditory beep or any other sound to indicate fetal heart rate, baby kick count, and/or results of the non-stress test.
  • the vibration motor 130 provides haptic feedback to the user.
  • the processor 108 can send a time-varying signal that corresponds to fetal heart beat, or baby kicks to the vibration motor 130, to provide a realistic feeling of touching the fetus to the user holding the device 100.
  • the time-varying signal changes at the same or proportional rate with accelerations and decelerations in heart rate directly impacting the periodicity of vibrations felt on the surface of the device 100.
  • FIG. 2 is a schematic diagram illustrating a method 200 of providing haptic feedback through device 100.
  • the time-varying signal is a pulse width modulated (PWM) waveform shown as representative PWM signal 202 (PWM signal 1 and PWM signal 2) that is modulated to simulate a beating heart taking into account the fast paced fetal heart auscultations and the minimum pulse width needed to best represent a single heartbeat.
  • PWM waveform's output is further time and frequency modulated to best represent a varying heartbeat's entire range - typically, ranging from 60 to 240 for a fetus.
  • An overview of the method steps followed is as follows: In step 204, an input signal from Sensor/Transducer 104 (FIGS.
  • step 206 the processing unit 108 receives the signal and digitizes it.
  • step 208 the digitized signal is used to calculate the fetal heart rate (r), usually in the range of 60 beats per minute to 240 beats per minute.
  • the parameters x, y, and z are calculated before calculating the actuation signal S, in sub- steps of the step 210, which include sub-steps 210A, where Pre-Defined Pulse width Ton maxima (x) is calculated for sensing one (1) Heart beat, sub-step 210B, where Pre-defined Pulse width T on maxima (y) is calculated for sensing one (1) Heart beat, sub-step 2 IOC, where Pre-defined Pulse width T 0 ff maxima (z) is calculated for distinctly sensing simultaneous Heart beats.
  • the generated time-varying actuation signal is sent to the vibration motor to provide haptic feedback. Referring to FIG.
  • the isolation component 112 acts as a haptic feedback providing surface by vibrating along with the vibration motor 130.
  • the isolation component 112 provides haptic feedback to the hand of the pregnant woman or any other person holding the device 100.
  • the air gap between isolation component 112 and the isolation component base frame 122 and the vibration dampening capability of the isolation component 112 prevents the vibrations produced by the vibration motor 130 to move towards the transducer 104 and create inadvertent noise in the signals transmitted or received by the transducer 104.
  • FIGS. 3A and 3B illustrate a second embodiment of the portable auscultation device 300, wherein FIG. 3A illustrates a top region of the device 300, and FIG. 3B illustrates a bottom region of the second embodiment of the device 300. Similar to the first embodiment (device 100 of FIGS.
  • the device 300 includes a device housing 302, a transducer 304 that captures a physiological signal indicative of a condition of a fetal heart and converts the physiological signal in an electrical signal, a transducer housing 306 attached to the device housing 302 for holding the transducer 304, a processor 308 that processes the electrical signal produced by the transducer 304, and a haptic feedback system 310 disposed on the device housing 302 that provides a haptic feedback to a user contacting the device housing 302 based on the processed electrical signal, wherein, the haptic feedback system 310 includes an isolation component 312 that isolates the haptic feedback system 310 from the transducer 304.
  • the device 300 may include additional components such as a display 314, a wired charging and/or data port 316, a switch 318, a battery 320, and a speaker 322.
  • the device housing 302 is shaped as a glove for wearing on a user's hand and is made of multiple layers.
  • the glove 302 includes three layers, an outer layer 324, a middle layer 326, and an inner layer 328.
  • the outer layer 324 forms the exterior surface of the glove 302
  • the middle layer 326 holds the haptic feedback system 310
  • the inner layer 328 contacts the surface of the user's hand.
  • the electrical components, display 314, wired charging and/or data port 316, switch 318, battery 320, and speaker 322 are mounted on a PCB 330 and connected in a circuit similar to the circuit described with FIG. 2 above via conductive traces or conducting wires.
  • the PCB 330 can be embedded between the outer layer 324 and the middle layer 326 of the glove, with cut-out or transparent section or window on the outer layer 324 for the user to view the display 314.
  • the PCB 330 along with the electrical components is housed in a plastic casing attached to the outer surface of the glove 302.
  • the bottom or the anterior surface of the glove 302 includes the transducer 304 embedded in the transducer housing 306.
  • the transducer 304 is a piezoelectric ultrasound transducer.
  • the transducer housing 306 can be embedded between the outer layer 324 and the middle layer 326 of the glove 302 or attached to the outer surface of the glove 302.
  • the transducer 304 is connected to the PCB 330 via an insulated electrical conductor passing through the outer layer 324 and the middle layer 326 of the glove 302.
  • the isolation component 312 is a vibration dampening member separating the transducer housing 306 from the middle layer 326 of the glove 302.
  • the isolation component 312 is made of a pliable vibration absorbing material such as soft rubbers, polymers, fabrics, leathers, foams, or gels, air bladders.
  • the isolation component 312 is made of a soft and durable material with high vibration absorption properties, for example, rubber.
  • the middle layer 326 is made of vibration absorbing material and acts as the isolation component 312.
  • the outer layer 324 and the inner layer 328 of the glove 302 are designed to be soft and comfortable for users.
  • the outer layer 324 and the inner layer are made of soft fabric, leather, felt, or polymer.
  • the outer layer 324 is made of leather, while the inner layer 328 is made of a soft felt.
  • the outer and the inner layers 324 and 328 respectively are made of or coated with electrical and thermal insulating materials to prevent any inadvertent electrical shock to the user.
  • the region between the inner layer 328 and middle layer 326 of the glove forms part of the haptic feedback system 310.
  • the region between the middle layer 326 and the inner layer 328 may include a piezo-film 332 to provide vibrational feedback to the user.
  • the piezo-film 332 is positioned on the top or posterior portion of the glove below the PCB 330.
  • the piezo-film can be positioned anywhere on the surface of the glove.
  • the region between the inner layer 328 and middle layer 326 includes a mesh of electro-active material that upon electrical stimulation contracts and expands to provide haptic feedback.
  • the haptic feedback system 310 is provided on the inner-surface of the inner layer 328 directly contacting the hand of the user.
  • the PCB 330 includes a data storage (not shown) for storing data.
  • the processor 308 may store the calculated information recorded over a period of time in the data storage for future use or for comparing present and past data to analyze long term fetal health.
  • the data storage can be a memory card or any other form of data storage device known in the art that can be accommodated within the glove 302 along with the other components.
  • the data stored in the data storage can be transmitted to a more capable computing device such as a laptop, computer, or a mobile phone, via the wired charging and/or data port 316 or any wireless means, such as Bluetooth or Wi-Fi.
  • the PCB 330 includes a power management circuit (not shown), known in the art to transfer power from the battery 320 to the electrical/electronic components within the device 300, i.e. the processor 308, transducer 304, display 314, wired charging and/or data port 316, switch 318, piezo- film 332, and the speaker 322.
  • the power management circuit distributes and regulates power from the battery 320 to the electrical components, when the switch 318 is turned on and restricts power distribution when the switch 318 is turned off.
  • a person of ordinary skill in the art can implement a number of known power management circuits.
  • the structural and electrical components of the device 300 can be manufactured and assembled by processes known in the art. For example different layers of the glove can be stitched together with a polymer or fabric thread or glued together with an adhesive. Further, the electrical components can be off-the shelf components assembled together to form the electrical circuit of the device 300.
  • the functioning of the device 300 is similar to the device 100.
  • the processor 308 signals the transducer 304 to start emitting ultrasonic transmissions and receiving the reflections of the said ultrasonic transmissions. The reflections of the ultrasonic transmissions are then picked up by the transducer and transmitted back to the processor 308.
  • the processor 308 with the aid of other hardware components on the PCB 330 and software filter implementations, processes and filters the reflections or reflected signals to reduce noise and extracts fetal heart auscultation signals, and/or baby kick signals.
  • the processor 308 then calculates Doppler shift in the filtered received signals to calculate fetal heart rate and/or baby kicks.
  • the processor 308 can further perform a Non-stress test on the basis of the calculated information.
  • the processor 308 then sends the calculated information to the peripheral output devices, i.e. the display 314, piezo-film 332, and speaker 322 for providing feedback to the user.
  • the display 314 can display the fetal heart rate, baby kick count, results of the non-stress test, while the audio speaker 322 can provide an auditory beep or any other sound to indicate fetal heart rate, baby kick count, and/or results of the non-stress test.
  • the piezo-film 332 provides haptic feedback to the user by vibrating.
  • the processor 308 can send a time-varying signal that corresponds to fetal heart beat, or baby kicks to the piezo-film 332, to provide a realistic feeling of touching the fetus to the user wearing the device 300.
  • the isolation component 312 isolates the transducer 304 from any vibrations created by the piezo-film 332.
  • a vibration motor (not shown) is mounted on the PCB 330, similar to the first embodiment (device 100) to provide haptic feedback.
  • FIGS 4A and 4B illustrate the use of the portable auscultation device, wherein FIG. 4A illustrates use of the embodiment of FIGS. 1 A and IB, and FIG. 4B illustrates use of the embodiment of FIGS. 3A, and 3B.
  • the device 100 of the first embodiment can be used by a pregnant mother or any other person by holding the device in her hand and placing the distal end of the device 100 that includes the transducer 104 on the pregnant mother's womb.
  • the device 100 (referring to FIG. 1A and IB), as discussed above observes the fetal heart auscultations and provides realistic haptic feedback to the hand of the pregnant mother holding the device 100 using the using the vibration motor 130, thereby helping nurture the emotional bond between the mother and the fetus.
  • the device 100 also emits sounds simulating the fetal heart through the speaker 132 and displays the calculated parameters on the display 114.
  • the pregnant mother or any other person holding the device 100 with this displayed information and audio and haptic feedback can know about the health of the fetus.
  • the device 300 of the second embodiment can be used by a pregnant mother or any other person by wearing the device 300 in her hand and placing the anterior end the device 300 that includes the transducer 304 on pregnant mother's womb.
  • the device 300 (referring to FIG. 3A and 3B), as discussed above observes the fetal heart auscultations and provides realistic haptic feedback to the hand of the pregnant mother wearing the device 300 using piezo-film 332, thereby forming an emotional connection between the mother and the fetus.
  • the device 300 also emits sounds simulating the fetal heart through the speaker 322 and displays the calculated parameters on the display 314.
  • FIG 5A and 5B illustrates a third embodiment of the portable auscultation device 500, wherein FIG 5A is a perspective view of the portable auscultation device 500 and FIG. 5B is an exploded view of the first embodiment of the portable auscultation device 500.
  • the third embodiment 500 includes a device housing 502, a transducer 504, a transducer housing 506, a processor 508, a haptic feedback system 510, an haptic feedback surface 512, a visual indicator 514, a wired or wireless charging and/or data port 116, a switch 118, a rigid frame 520, a printed circuit board 524, a battery 528, and a vibration motor (not shown).
  • the vibration motor is mounted behind the haptic feedback surface 512 to provide feedback to the user.
  • the dimensions, electrical component selection, and material selection for the embodiment 500 will remain similar to the embodiment 100 discussed above.
  • the embodiment of device 500 includes an isolation component 505 that provides an air gap and isolates the transducer housing 506 and the transducer 504 from the vibrations generated in the device housing 502 by the haptic feedback system 510.
  • the isolation component 505, similar to isolation 112 of first embodiment is made of a pliable vibration absorbing material such as soft rubbers, polymers, fabrics, leathers, foams, air bladders or gels.
  • the isolation component 505 is made of a soft and durable material with high vibration absorption properties, for example, rubber.
  • the visual indicator 514 can be a LED light instead of a LCD display.
  • FIGS 6A and 6B illustrate a fourth embodiment of the portable auscultation device, wherein FIG 6A illustrates the portable auscultation device and FIG. 6B illustrates the portable auscultation device with a belt.
  • the device 600 is similar to the previous embodiments 100 and 500 of the portable auscultation device in construction, electrical arrangement, and material selection. However, the device 600 is shaped to be worn on a belt, and includes a groove 602 to accommodate a belt 604 (FIG. 6B). However, other attachment mechanisms can also be used such as clips, Velcro, buttons, etc. to attach the auscultation device 600 to a belt around the waist of the user.
  • FIGS 6A and 6B illustrate a fourth embodiment of the portable auscultation device, wherein FIG 6A illustrates the portable auscultation device and FIG. 6B illustrates the portable auscultation device with a belt.
  • the device 600 is similar to the previous embodiments 100 and 500 of the portable auscultation device in construction, electrical arrangement, and material selection. However, the device 600 is shaped to be
  • the present invention presents an advantage that it provides a portable auscultation device that can be easily used at home by a pregnant family. 2. Another advantage presented by the present invention is that it provides a portable auscultation device that can provide realistic haptic feedback to the person holding or wearing the device.
  • Yet another advantage presented by the present invention is that in enables performing a Non-stress test towards the later stages of pregnancy by a pregnant mother herself in the comfort and privacy of one's own home.

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  • Reproductive Health (AREA)
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  • Pregnancy & Childbirth (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Pediatric Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un dispositif d'auscultation portable qui comprend un boîtier de dispositif, et un transducteur qui capture un signal physiologique indicatif d'un état d'un coeur foetal et convertit le signal physiologique en un signal électrique. Le dispositif comprend également un boîtier de transducteur fixé au boîtier de dispositif pour maintenir le transducteur. Le dispositif comprend en outre un processeur qui traite le signal électrique produit par le transducteur. En outre, le dispositif comprend un système de retour d'information haptique disposé sur le boîtier de dispositif qui fournit un retour d'information haptique à un utilisateur en contact avec le boîtier de dispositif sur la base du signal électrique traité. Le système de retour d'information haptique comprend un composant d'isolation qui isole le système de retour d'information haptique du transducteur.
PCT/IN2018/050022 2017-01-17 2018-01-16 Dispositif d'auscultation portable WO2018134844A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3881759A1 (fr) * 2020-03-19 2021-09-22 Nederlandse Organisatie voor toegepast- natuurwetenschappelijk Onderzoek TNO Dispositif de surveillance du rythme cardiaque f tal et son procédé de commande

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Publication number Priority date Publication date Assignee Title
US20160100817A1 (en) * 2014-10-14 2016-04-14 Arsil Nayyar Hussain Systems, devices, and methods for capturing and outputting data regarding a bodily characteristic

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160100817A1 (en) * 2014-10-14 2016-04-14 Arsil Nayyar Hussain Systems, devices, and methods for capturing and outputting data regarding a bodily characteristic

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3881759A1 (fr) * 2020-03-19 2021-09-22 Nederlandse Organisatie voor toegepast- natuurwetenschappelijk Onderzoek TNO Dispositif de surveillance du rythme cardiaque f tal et son procédé de commande
WO2021187984A1 (fr) * 2020-03-19 2021-09-23 Nederlandse Organisatie Voor Toegepast- Natuurwetenschappelijk Onderzoek Tno Dispositif de surveillance de fréquence cardiaque fœtale et son procédé de commande
CN115460981A (zh) * 2020-03-19 2022-12-09 荷兰应用自然科学研究组织Tno 胎儿心率监测装置和控制胎儿心率监测装置的方法
US20230113978A1 (en) * 2020-03-19 2023-04-13 Nederlandse Organisatie Voor Toegepast-Natuurwetenschappelijk Onderzoek Tno Fetal heart rate monitoring device and method of controlling thereof

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