Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
  • A61B8/0866—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/06—Devices, other than using radiation, for detecting or locating foreign bodies ; determining position of probes within or on the body of the patient
  • A61B5/061—Determining position of a probe within the body employing means separate from the probe, e.g. sensing internal probe position employing impedance electrodes on the surface of the body
• • 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
  • A61B5/4356—Assessing uterine contractions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/02—Measuring pulse or heart rate
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/42—Details of probe positioning or probe attachment to the patient
  • A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
  • A61B8/4236—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by adhesive patches
• • 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
  • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
  • A61B8/4472—Wireless probes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/56—Details of data transmission or power supply

Definitions

• the present invention relates to a device for monitoring labor contractions during childbirth.
• the present invention relates to a fiber optic labor contraction sensor adapted to adhere to a female's abdomen without the use of a belt or strap.
• the beltless fiber optic labor contraction sensor includes a fiber optic strain sensor that generates an output signal in response to labor contractions and communicates the output signal to a signal transceiver.
• the signal transceiver is operable to communicate the incidence of labor contractions through radiotelemetry or other wireless communication.
• the heart rate of a fetus may be determined by using an ultrasound transducer to measure the Doppier shift of an ultrasound signal reflected from the moving fetal heart.
• ultrasound fetal heart rate measurements are described, for example, in U.S. Patent No. 6,379,305 (Eugley), U.S. Patent No. 5,827,969 (Lee et al. I), U.S. Patent No. 5,640,960 (Jones et al.), U.S. Patent No. 5,630,418 (Lee et al. II), U.S. Patent No, 5,289,820 (Beach et al. I), U.S. Patent No.
• ultrasound devices used for measuring fetal heart rate have several drawbacks.
• ultrasound devices typically used by obstetricians in their offices generally involve bulky, cabinet-type or cart-mounted devices having a wand or probe that the obstetrician places on the abdomen of the pregnant mother, usually with some gel to enhance the performance of the ultrasound transducer.
• such devices require the presence and attention of the obstetrician during operation.
• hand-held ultrasound devices are commercially available for use at home, such as the Belly BeatsTM fetal Doppier heart monitor described at www.bellybeats.com or the SweetbeatsTM fetal Doppier heart monitor described at www.sweetbeats.net
• such hand-held devices require the mother or another person to apply a gel and hold the wand in place on the mother's abdomen much like the more sophisticated devices used by obstetricians.
• such devices are portable, they are cumbersome to carry around and are not suitable for continuous use.
• a labor contraction sensing device includes a fiber optic strain sensor that is adhered to the mother's abdomen for detecting the strength and frequency of labor contractions during childbirth.
• the fiber optic strain sensor is in signal communication with a signal transceiver having a signal transmitter that is preferably in wireless communication with a standard contraction recording device or other monitoring equipment.
• a fiber optic strain sensor including at least one fiber optic cable having first and second ends.
• a light source is located at one end of the fiber optic cable for transmitting a light beam through the fiber optic cable to the opposite end of the fiber optic cable.
• a light detector is located at the opposite end of the cable for detecting fluctuations in the transmitted fiber optic light beam.
• any external forces acting against the fiber optic cable results in changes in the optical signal of the transmitted light beam. These fluctuations are detected by the light detector and an appropriate output signal is generated by optical signal processing electronics.
• the sensor output signal is communicated to a signal transceiver, which includes a signal receiver and transmitter.
• the same fiber optic cable or a separate fiber optic cable may also be used to provide a visual indication of the labor contraction.
• the signal transmitter is a radio transmitter. Utilizing a radio transmitter as the signal transmitter provides the user with wireless communication between the labor contraction sensing device and a standard contraction recording system.
• the fiber optic strain sensor is specially designed to be adhered to the mother's abdomen without the use of a belt. Specifically, the fiber optic strain sensor preferably includes an adhesive surface or is placed within an adhesive cover or jacket that allows the fiber optic strain sensor to be conveniently and comfortably adhered to the abdomen of the mother.
• the beltless design together with wireless communication provides a labor contraction sensing device that offers increased mobility to the expecting mother relative to existing contraction sensing devices.
• the labor contraction output signals may be indicated via an output device either locally at the labor contraction sensing device or remotely at a separate monitoring station.
• an ultrasound fetal heart rate monitoring apparatus is provided with an adhesive pad for adhering the apparatus to the abdomen of a pregnant female without the use of a belt.
• An ultrasound transducer and associated electronics within the apparatus are operable to measure the fetal heart rate according to methods known in the art.
• Output signals representative of the fetal heart rate may be indicated at the apparatus itself via a visual display or a speaker, for example, or the output signals may be transmitted via a wireless signal transmitter to a remote monitoring station, such as a nurse's station.
• the apparatus may also include a fiber optic cable or other light-generating member for providing a visual indication of the fetal heartbeat.
• the apparatus may also be used to monitor the heart rate of other living individuals, such as children and adults, by placing the apparatus on the body of such individuals, preferably on the chest, side, or back.
• both a fiber optic labor contraction sensor and an ultrasound transducer are provided in an apparatus having an adhesive pad for attaching the apparatus to the abdomen of a pregnant female without the use of a belt.
• Separate fiber optic cables may be used for monitoring labor contractions and providing a visual indication of the fetal heart rate, or the same fiber optic able may be used both for sensing labor contractions and providing a visual indication of the fetal heartbeat.
• the fetal heartbeat output signals may be indicated via an output device either locally at the ultrasound fetal heart rate sensing device or remotely at a separate monitoring station.
• FIG. 1 is a top perspective view of a labor contraction sensing device in accordance with the present invention.
• FIG. 2 is a side perspective view of the labor contraction sensing device of FIG. 1.
• FIG. 3 is a partially cross-sectional, partially schematic top view of the labor contraction sensing device illustrated in FIG. 1.
• FIG. 4 is a cross-sectional side view of a preferred embodiment of a labor contraction sensing device in accordance with the present invention installed on the abdomen of a pregnant female.
• FIG. 5 is a cross-sectional side view of an alternative embodiment of a labor contraction sensing device in accordance with the present invention installed on the abdomen of a pregnant female.
• FIG. 6 is a top perspective view of a fetal heart rate monitoring device in accordance with the present invention.
• FIG. 7 is a cross-sectional side view of the fetal heart rate monitoring device of FIG. 6 taken in the direction of arrows 7-7.
• FIG. 8 is a cross-sectional side view of an alternative fetal heart rate monitoring device in accordance with the present invention.
• FIG. 9 is a perspective view of the electronics box and fiber optic cable connection of the device of FIG. 8.
• FIG. 10 is a top view of a portion of a combined labor contraction and fetal heart rate monitoring device in accordance with the present invention showing one preferred layout of fiberoptic cables therein.
• FIG. 11 is a top view of a portion of a combined labor contraction and fetal heart rate monitoring device in accordance with the present invention showing an alternative layout of fiber optic cables therein.
• FIG. 12 is a cross-sectional side view of another embodiment of a combined labor contraction and fetal heart rate monitoring device in accordance with the present invention.
• FIG. 13 is a top perspective view of yet another embodiment of a combined labor contraction and fetal heart rate monitoring device in accordance with the present invention.
• FIG. 14 is a schematic block diagram of a fetal heart rate monitoring device in accordance with the present invention.
• FIG. 15 is a schematic block diagram of a combined labor contraction and fetal heart rate monitoring device in accordance with the present invention.
• FIG. 16 is a top view of another embodiment of a fetal heart rate monitoring device in accordance with the present invention.
• FIG. 17 is a side view of the fetal heart rate monitoring device of FIG 16.
• FIG. 18 is cross-sectional view of the fetal heart rate monitoring device of FIG. 16 taken in the direction of arrows 18-18.
• FIG. 19 is a schematic view showing the fetal heart rate monitoring device of FIG. 16 placed on the abdomen of a pregnant female. Detailed Description
• the term “fiber optic strain sensor” can refer to any optical detection system utilizing fiber optics, wires, lines, or cables through which a light beam is passed and fluctuations or changes in that light beam caused by the external application of force upon the system are identified as changes in the transmitted optical signal.
• the term “fiber optic cable” should be understood to mean any optical transmission line through which a light beam may be passed.
• the term “communication” should be understood to encompass direct or indirect communication. That is, two components that are said to be in communication with one another may be in direct communication with each other without any intermediate components, or the two components may be in indirect communication with each other through one or more intermediate components.
• the term "light- generating member” should be understood to mean any device that is capable of producing light.
• the term “sound-generating member” should be understood to mean any device that is capable of producing sound.
• the term "computer processor” as used herein should be understood to mean any electronic information processor, including but not limited to a microprocessor, a digital signal processor, or the like.
• the term “output device” should be understood to mean any device that is capable of producing an indication of an event or condition, whether by sound, light, vibration, smells, or any other indication susceptible of sensory perception.
• a contraction sensing device (10) embodying the present invention comprises a fiber optic strain sensor (12) having a generally elliptical shape to better conform to the contour of the mother's abdomen.
• the strain sensor (12) is secured to an adhesive pad (14) that provides removable attachment of the strain sensor (12) to the mother's skin surface (44).
• a signal line (16) provides communication between the sensor electronics housed in an electrical box (18) and the fiber optic portion of the strain sensor (12).
• the electronics box (18) houses a wireless signal transmitter (28) for transmitting an output signal that corresponds to the labor contractions detected by the strain sensor (12).
• the mother's movement is therefore not restricted by one or more communication lines extending between the device (10) and a standard contraction recording device as are present with standard contraction monitoring systems.
• the strain sensor (12) and underlying adhesive pad (14) are preferably thin.
• Such a narrow design is not bulky or cumbersome, and thus it reduces user discomfort associated with traditional contraction monitoring systems.
• the preferred embodiment is designed to be narrow in thickness, multiple surface shapes and configurations can be used without deviating from the scope of the present invention.
• the sensing device (10) can have rectangular or circular surfaces.
• the sensing device (10) can be fabricated with different surface portions having alternate shapes for conforming to varying contours of the abdominal surface. It is preferable, however, that the strain sensor be fabricated as narrow as possible to maximize user comfort.
• a signal line (16) provides communication between the strain sensor (12) and the electronics box (18).
• Such components include a light source, light detector and optical signal processing electronics.
• a preferred embodiment includes a wireless signal transmitter (28) operable to communicate with a contraction recording device.
• contraction recording devices are well known in the art and one skilled in the art would readily know how to place the recording device in wireless communication with the signal transmitter.
• the preferred strain sensor (12) includes a fiber optic cable (20) embedded within a sensor cover (32).
• some or all of the electronic components including a light source, light detector, optical signal processing electronics and power supply may be embedded within the sensor cover (32).
• the sensor cover (32) is preferably fabricated from soft flexible plastic; however, any other material that is flexibly responsive to labor induced changes in the surface contour of the mother's abdomen can be used.
• materials suitable for use in the present invention include rubber, fabric, nylon mesh, or other like materials.
• the fiber optic sensor (12) may be held against the skin surface (44) by a conventional drape (not shown). More particularly, the drape is shaped to overly the sensor (12) and the perimeter of the drape is adapted to engage the skin surface (44) so that the sensor (12) 15 held firmly against the skin surface (44).
• a preferred embodiment of the present invention provides unitary fabrication of the strain sensor (12) and adhesive pad (14).
• the adhesive pad (14) and sensor (12) are made as a single component for more cost effective fabrication and convenient disposal following use.
• a preferred adhesive pad (14) includes a lower adhesive surface (36a) and upper cover surface (36b).
• the upper and lower surfaces (36a-b) of the adhesive pad (14) are joined together to form a sensor jacket (22) defining an interior compartment or pouch (54) for holding the electronics box (18) and any other necessary components.
• the inner edge of the lower surface (36a) of the adhesive pad (14) is preferably attached about the outer edge (48) of the sensor cover (32) using commonly known welding or stitching techniques.
• many of the components, including the sensor jacket (22), sensor cover (32) and adhesive pad (14) can be formed from single or multiple layers of a flexible polymer sheet (or drape), or mesh fabric.
• a suitable material for forming these components is a clear polymer sheet sold under the tradename "TEGADERM" from Minnesota, Mining and Manufacturing Company, which is commonly known as 3M.
• TEGADERM a clear polymer sheet sold under the tradename "TEGADERM" from Minnesota, Mining and Manufacturing Company, which is commonly known as 3M.
• the sensor lower surface (50) can also have an adhesive surface for providing further attachment to the skin surface (44).
• the components housed in the electronics box (18) are embedded together with the fiber optic cable (20) within the sensor cover (32) to form the sensor (12).
• the sensor (12) is positioned against the mother's skin surface (44) and a drape material such as the polymer sheet described above is placed in overlying relation to the sensor (12). The perimeter of the drape material is then adapted to engage the mother's skin surface (44) such that the sensor (12) is held against the mother's abdomen.
• the sensor (12) is held within a sensor jacket (52) in overlapping relation to the adhesive pad (14).
• the adhesive pad (14) is provided with an upper adhesive surface (34a) for holding the sensor (12) and a lower adhesive surface (34b) for adhering to the mother's skin (44).
• Providing pad (14) with an upper adhesive surface (34) allows for the removable detachment of the strain sensor (12) from the adhesive pad (14), thereby enabling the user to recycle the strain sensor (12) together with a new adhesive pad (14).
• the sensor (12) and pad (14) can be detachably connected or fabricated as an integral component.
• the electronics box (18) is preferably not fabricated as a disposable component.
• the electronics box (18) can be provided with an adhesive surface (46) for adhering the box (18) to the surface of the sensor cover (32), or alternatively, for adhering the electronics box (18) directly to the mother's skin surface (44).
• the electronics box (18) can be releasably positioned within the pouch (54) of the sensor jacket (22). In this way, the user of the device (10) simply inserts the electronic box (18) into the jacket pouch (54) and plugs the signal line (16) into a socket (56) to connect the fiber optic cable (20) with the electronics box (18), which houses the light source (30), light detector (24) and signal transceiver (42). As shown in FIG.
• the box (18) is preferably provided as a component apart from the sensor (12). In either embodiment shown in FIGS. 3 and 4, however, the electronics box (18) can be readily unplugged from the fiber optic cable (20) or signal line (16) and the used sensor (12), pad (14) and/or jacket (22) properly disposed of. Though it is envisioned that the electronics box (18) is fabricated as a separate component, the electronics could be provided as an integral component of the device (10) without deviating from the scope of the present invention.
• the strain sensor (12) preferably comprises a fiber optic cable or other optical transmission line (20) embedded within a sensor cover (32).
• the fiber optic cable (20) has a first end (38) and a second end (40).
• the fiber optic cable (20) can be any typical fiber optic cable or other optical transmission line known to those skilled in the art.
• a light source (30) is positioned adjacent to the first end (38) for transmitting a light beam or optical signal through the fiber optic cable (20).
• a light detector (24a) and signal decoder (24b) Positioned adjacent to the second end (40) of the fiber optic cable (20) is a light detector (24a) and signal decoder (24b) for monitoring variations in the optical signal as it passes through the fiber optic cable (20).
• the light source (30) transmits a light beam through the fiber optic cable (20) and any external applications of force against the cable (20), such as the force of a labor contraction, results in fluctuations in the optical signal that are identified by the light detector (24a) as changes in the optical signal.
• a signal decoder (24b) is operable to decode the identified optical signal and generate an appropriate response, such as an electrical output signal, that is transmitted to a signal transceiver (42).
• the signal transceiver (42) comprises a signal receiver (26) in communication with a signal transmitter (28).
• the signal receiver (26) is operable to transmit the output signal received from the signal decoder (24b) to the signal transmitter (28).
• the signal transmitter (28) is a radio transmitter in wireless communication with a standard contraction recording device.
• other wireless communication devices can be used without deviating from the scope of the present invention.
• any number of light sources (30) can be used with the present invention.
• Such light sources (30) include light emitting diodes. For instance, an infrared laser diode is a suitable light source for use with the present invention.
• the present invention further includes a light detector (24a) responsive to changes in light beam emitted by the light source (30).
• a light detector 24a
• the light detector (24a) can be a phototransistor, a photocell, a photosensitive diode or any other suitable light detector known in the art.
• the signal decoder (24b) can include any of the various optical signal processing electronics known in the art. It should be understood, however, that in a broad sense the signal decoder (24b) is operable to convert into an appropriate output signal any change in the optical signal detected by the light detector (24a).
• the signal transmitter (28) is a radio transmitter or other like wireless signal transmitter. Again, it is well known to those skilled in the art the extensive variety of radio transmitters that can be used in the present invention. In a preferred embodiment, the radio transmitter bandwidth is unique to the particular contraction recording device so as to prevent interference of the radio signal with other radio transmitting labor contraction devices (10) that may be in use. In this embodiment, the signal transmitter (28) can also provide communication with other monitoring equipment besides the contraction recording device. For instance, the transmitter (28) can be in communication with computer analysis equipment located at the nurses station or other remote location. It should also be understood that the transmitter (28) should provide a sufficient range of communication between the device (10) and the monitoring equipment to allow the mother to move freely about during the childbirth process. For example, a preferred transmitter (28) allows the mother to move outside the hospital room or about her own house during childbirth. Signal transmitters (28) providing the required range of communication distance are well known in the art.
• the fiber optic strain sensor (12) preferably comprises a single loop of fiber optic cable (20).
• the optical signal transmitted through the cable (20) is assigned a normal value.
• force such as with a labor contraction
• the cable (20) is distorted from its normal shape and a change in the optical signal of the light transmitted through the cable occurs. This change is detected by the light detector (24) and the signal is assigned a new value.
• the present invention covers within its scope the use of more than one fiber optic cable (20) to amplify any changes in the optical signal.
• a fiber optic sensor (12) can be provided having multiple fiber optic cables placed in parallel, wherein each individual cable (20) can be positioned at varying locations along the surface of the mother ' s abdomen.
• more than one detector and/or light source can be utilized without deviating from the scope of the present invention.
• power for the present invention can be provided by way of a standard power source (not shown).
• the power source should be sufficient to provide continuous power to the device (10) for the entire period of labor.
• Suitable power sources generally include a battery pack comprising cadmium oxide or silver oxide batteries. It is clear, however, that the utilized batteries should be sized to allow packaging within the electronics box (18) or other placement so as to not limit patient mobility.
• a beltless ultrasound fetal heart rate sensing device 60 having an electronics box (66) that contains, among other things, an ultrasound transducer (148).
• Ultrasound transducer (148) which preferably comprises one or more piezo-electric crystals as known in the art, may be any type of device that is capable of transmitting ultrasound waves toward the fetal heart.
• the ultrasound transducer of the CorometricsTM 170 series fetal monitors available from General Electric could be adapted for use in the present invention.
• Electronics box (66) is preferably connected to a fiber optic cable (64), which is preferably embedded in a flexible pad (62) having a translucent top layer (82) and a lower layer (84) that may be translucent or opaque.
• Flexible pad (62) is preferably made of a soft, flexible plastic, much like sensor cover (32) described above.
• Pad (62) may also be made of any other suitable material that is adaptable for conforming to the contour of the mother's abdomen, such as rubber, fabric, or other similar materials.
• An adhesive layer (80) is preferably provided underneath the lower layer (84) of pad (62) for affixing device (60) to the abdomen of a pregnant female without the use of a belt.
• Adhesive layer (80) preferably has a peel-off backing (not shown) as is known in the art.
• lower layer (84) may be made of a type of plastic that readily adheres to skin.
• pad (62) preferably has a generally elliptical shape for better conforming to the contour of the mother's abdomen, but any other suitable shape may also be used.
• a gel pad (78) is preferably provided underneath electronics box (66) to enhance the performance of the ultrasound transducer (148), much like traditional gels or lotions that are used with conventional ultrasound devices, except that gel pad (78) is more convenient because it is self-contained and not as messy as a traditional gel or lotion.
• gel pad (78) may be made from defibrillator pads such as stock number 2346N available from 3MTM (Minnesota Mining & Manufacturing).
• electronics box (66) preferably has a power supply (140), such as a battery, preferably a rechargeable battery, which supplies power to a microprocessor (142) and other electronic components within electronics box (66).
• a memory unit (146) may be provided in electronic communication with microprocessor (142) for storing information generated by device (60) as discussed further below.
• An input/output (I/O) unit (144) is also preferably provided in electronic communication with microprocessor (142) to facilitate control of device (60) by the user and output of information to the user according to methods well known in the art.
• Ultrasound transducer (148) which is controlled by microprocessor (142), transmits ultrasound waves which are reflected off the moving fetal heart, and the reflected waves are received by a signal receiver (150), which may be part of ultrasound transducer (148). Indeed, in a preferred embodiment, the same piezo-electric crystal or crystals which transmit ultrasound waves also receive the reflected, Doppier shifted waves as known in the art.
• Signal receiver (150) preferably sends the resulting signals to a signal conditioner (152), which processes the received signals according to methods known in the art.
• Signal conditioner (152) then sends the conditioned signals to a signal transmitter (154), which in turn sends control signals to a light source (156), which may be any suitable type of light-generating member.
• fiber optic cable (64) In response to the control signals, light source (156) emits a periodic light beam into fiber optic cable (64) representative of each beat of the fetal heart. Because upper layer (82) of pad (62) is preferably translucent, the light within fiber optic cable 64 is visible from outside the device (60). Fiber optic cable (64) thus serves as a visual indication of the fetal heartbeat. As shown in FIG. 6, fiber optic cable (64) may be configured in a heart shape as an additional symbolic confirmation that the fetal heartbeat is being represented by the flashing light passing through cable (64). However, cable (64) may be configured in any desired shape other than a heart shape. ] In the embodiment illustrated in FIGS. 6 and 7, the outer surface of electronics box
• I/O unit (144) is preferably provided with a number of control and output elements as part of I/O unit (144) that are accessible by the user.
• I/O unit (144) may have a master on-off switch (68) for turning device (60) on and off and a light on-off switch (70) for controlling the operation of light source (156).
• a speaker (76) or other sound-generating member may also be provided as part of I/O unit (144) for producing an audible indication of the fetal heartbeat in response to the control signals from signal transmitter (154), in which case a volume control (72) and a speaker on-off switch (74) are preferably provided to control the operation of speaker (76).
• a display unit may be provided as part of I/O unit (144) for producing a textual or graphical representation of one or more characteristics of the fetal heartbeat.
• I/O unit 144
• a display unit may indicate the average fetal heart rate per unit time, such as the number of beats per minute.
• a vibrator (not shown) or other type of output device may be provided to give another type of indication of the fetal heart rate in response to the control signals from signal transmitter (154).
• light source (156), speaker (76), and any other included output device may be controlled independently of one another.
• the user may choose to see a visual indication of the fetal heartbeat as represented by cable (64) without any sound being produced by speaker (76), or the user may choose to hear an audible indication of the fetal heartbeat as produced by speaker (76) without any light being emitted by cable (64), or the user may choose to obtain both a visual indication and an audible indication of the fetal heartbeat by operating both cable (64) and speaker (76) simultaneously.
• device (60) may be provided with a wireless transmitter (not shown) for transmitting a wireless signal representative of the fetal heartbeat to a remote monitoring station, such as a nurse's station. In this way, medical personnel could monitor the fetal heartbeat even if the mother chooses not to see or hear any indications of the fetal heartbeat at device (60), such as when the mother desires to sleep.
• the present invention may comprise an ultrasound apparatus as described for device (60) above but without a fiber optic cable (64).
• the output signals representative of the fetal heartbeat are preferably displayed visually on a display (not shown) or represented audibly via speaker (76) or otherwise indicated via some other output device as discussed above.
• an ultrasound fetal heart rate monitoring device (170) may comprise a flexible patch (172) having a recess or pouch for containing an ultrasound sensor (180).
• Patch (172) is preferably made of soft, flexible plastic or another suitable material, such as rubber or fabric, with adhesive on its underside surface (178) for securing device (170) to the abdominal skin (44) of a pregnant female.
• Ultrasound sensor (180) may be permanently embedded or integrally formed in patch (172), but ultrasound sensor (180) is preferably removable from patch (172) so that sensor (180) may be re-used.
• patch (172) preferably has a generally elliptical shape to help conform patch (172) to the contour of the mother's abdomen, but other shapes are also possible as discussed above.
• Ultrasound sensor (180) preferably has a power source (174), a signal processor (176), an ultrasound transducer (148), a signal transmitter (154), and a gel pad (78) for contacting the mother's abdominal skin (44) to enhance the performance of ultrasound transducer (148) as discussed above.
• ultrasound transducer (148) produces a signal representative of the fetal heartbeat in cooperation with signal processor (176) according to methods known in the art.
• signal transmitter (154) preferably transmits the resulting signal representative of the fetal heartbeat to a remote receiver for monitoring, preferably via wireless transmission.
• an alternative ultrasound fetal heart rate monitoring device (160) is shown in which electronics box (66) is placed within a pouch or compartment (164) formed by a cover (162).
• device (160) preferably has a gel pad (78) underneath electronics box (66) for contacting the skin (44) of the pregnant mother and an adhesive layer (80) for attaching device (160) to the skin (44) without the need for a belt.
• Fiber optic cable (64) is disposed within a pad (62) that comprises a lower layer (84) and an upper layer (82), which is preferably translucent.
• cover (162) is placed on top of pad (62) and forms a pouch or compartment (164) for housing the electronics box (66).
• cover (162) does not overlap the portion of pad (62) in the vicinity of cable (64) so that the light emitted by cable (64) in response to the fetal heartbeat is visible from outside device (160).
• the operation of electronics box (66) is preferably controlled by software or firmware, either within electronics box (66) or in a remote processor, according to methods known in the art.
• electronics box (66) may have the same types of controls as described above in connection with device (60), but the user would first need to open cover (162) to gain access to the controls on box (66) in compartment (164).
• cover (162) may permit operation of such controls on box (66) without opening cover (162).
• a cover (162) comprising a thin, flexible plastic would permit operation of controls on box (66) without the need for access to compartment (164).
• electronics box (66) is preferably removable from compartment (164) and the remainder of device (160) is disposable.
• fiber optic cable (64) preferably terminates with a connector (168) which is removably inserted into a mating jack (166) on box (66). In this manner, cable (64) may be unplugged from electronics box (66), which may be re-used in another device (160).
• pad (62) is preferably removable from adhesive layer (80) and gel pad (78) so that pad (62) may be re-used.
• a memory unit (146) is preferably provided in electronics box (66) to store information generated by device (60) or (160).
• microprocessor (142) may track the fetal heartbeat over time, calculate an average heart rate per a given unit of time, and periodically store such average heart rate in memory unit (146).
• microprocessor (142) may track the fetal heartbeat over time and store a record of each occurrence of a missed heartbeat in memory unit (146).
• memory unit (146) may be used to store many other types of information related to the fetal heartbeat.
• a combined labor contraction and fetal heart rate monitoring device may be achieved by combining the functionalities described above.
• such a combination device may comprise two separate fiber optic cables: one for the labor contraction monitoring function, and another for the fetal heart rate monitoring function.
• fiber optic cables (86) and (88) are embedded in the same pad (62), with cable (88) being connected to the labor contraction electronics box (18) and cable (86) being connected to the ultrasound fetal heart rate electronics box (66).
• FIG. 10 fiber optic cables (86) and (88) are embedded in the same pad (62), with cable (88) being connected to the labor contraction electronics box (18) and cable (86) being connected to the ultrasound fetal heart rate electronics box (66).
• FIG. 11 shows two separate fiber optic cables (90) and (92) embedded in the same pad (62) in a slightly different configuration, with cable (92) being connected to labor contraction electronics box (18) and cable (90) being connected to ultrasound fetal heart rate electronics box (66).
• cable (92) being connected to labor contraction electronics box (18)
• cable (90) being connected to ultrasound fetal heart rate electronics box (66).
• the fiber optic cables may be arranged in any desirable configuration.
• electronics boxes (18) and (66) are illustrated as being separate units, persons reasonably skilled in the art will appreciate that boxes (18) and (66) may be combined into a single electronics box having the full functionality of both labor contraction monitoring and fetal heart rate monitoring, such as electronics box (110) described below.
• device (100) for monitoring labor contractions and fetal heart rate is shown.
• a first fiber optic cable (104) for indicating the fetal heart rate is embedded within an upper layer (108)
• a second fiber optic cable (106) for sensing labor contractions is embedded within a lower layer (112).
• device (100) preferably has an adhesive layer (not shown) on its underside for attaching device (100) to the abdominal skin (44) of a pregnant mother.
• device (100) preferably has a gel pad (78) for placement adjacent the mother's skin for enhancing the performance of the ultrasound transducer, which is housed in electronics box (110).
• electronics box (110) is removably held in a receptacle (102) and contains the components of both electronics box (18) described above for labor contraction monitoring and electronics box (66) described above for ultrasound fetal heart rate monitoring.
• Upper layer (108) is preferably translucent so that the light emitted by cable (104) in response to the fetal heartbeat is visible from the exterior of device (100).
• Lower layer (112) is preferably opaque so that the light emitted by cable (104) does not interfere with cable (106).
• Cables (104) and (106) are connected to the ultrasound and labor contraction portions, respectively, of electronics box (110).
• fiber optic cable (104) may also be used to provide a visual indication of the occurrence and strength of a labor contraction.
• a continuous light signal may be superimposed over the periodic fetal heartbeat light signal in cable (104).
• the occurrence of a labor contraction may be indicated by a change in color of the light pulsing through cable (104).
• the intensity of the continuous light signal representative of the labor contraction may be increased or decreased according to the strength of the labor contraction. Referring to FIGS.
• an alternative combined labor contraction and fetal heart rate monitoring device (120) with an electronics box (130) is shown.
• the same fiber optic cable (124) is used both for sensing labor contractions and for visually indicating the fetal heartbeat.
• Cable (124) is preferably embedded in a soft, flexible pad (122) having a translucent outer layer above cable (124), much like pad (62) described above.
• device (120) preferably has an adhesive layer (not shown) on its underside for attaching device (120) to the skin of the mother and a gel pad (not shown) for enhancing the performance of the ultrasound transducer (148).
• a receptacle (126) is provided on pad (122) for removably holding electronics box (130).
• Cable (124) is connected to electronics box (130), preferably by one or more optical signal contact junctions (not shown) that mate with electronics box (130) when box (130) is snapped into place in receptacle (126). Suitable optical signal contact junctions are well known in the art.
• electronics box (130) contains the components of box (18) described above for processing the labor contraction signals and the components of box (66) described above for processing the ultrasound fetal heart rate signals.
• fiber optic cable (124) is in optical communication at one end with light source (156) and at another end with light detector (24a). Light source (156) emits substantially continuous light beams into cable (124) for monitoring labor contractions as discussed above in connection with FIGS.
• device (120) is useful in monitoring both labor contractions and fetal heart rates.
• fiber optic cable (124) may also be used to provide a visual indication of the occurrence and strength of a labor contraction. For example, upon the occurrence of a labor contraction, a continuous light signal may be superimposed over the periodic fetal heartbeat signal in cable (124).
• the occurrence of a labor contraction may be indicated by a change in color of the light pulsing through cable (124). Further, the intensity of the continuous light signal representative of the labor contraction may be increased or decreased according to the strength of the labor contraction.
• ambient light entering cable (124) should be offset according to methods known in the art.
• Various labor contraction data, such as frequency and strength, and fetal heartbeat data, such as average heart rate, may be stored in memory unit (146) according to methods known in the art.
• the ultrasound transducer (and thus the electronics box) to be substantially adjacent the skin of the mother, with only a gel pad separating the electronics box from the skin. If any other material is located between the skin and the ultrasound transducer, such other material is preferably sonically transparent so as not to interfere with the ultrasound signals.
• the electronics are described herein as preferably being contained in a box, the electronic components may be simply embedded in another part of the apparatus, such as a flexible pad.
• the ultrasound heart rate sensing devices described herein may also be used to monitor the heartbeat of an individual other than a fetus, such as a child or adult, by placing the sensing device on the body of the individual, preferably on the chest, side, or back of the individual.
• the operation of the ultrasound heart rate sensing device as applied to a child or adult would be the same as described herein for a pregnant mother. Therefore, the invention should not be limited to the details shown and described herein.

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• 2005
  • 2005-05-11 CA CA002569409A patent/CA2569409A1/en not_active Abandoned
  • 2005-05-11 WO PCT/US2005/016406 patent/WO2005110236A1/en active Application Filing
  • 2005-05-11 EP EP05748409A patent/EP1750587A4/de not_active Withdrawn

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