WO1993018710A1

WO1993018710A1 - Fetal monitoring system

Info

Publication number: WO1993018710A1
Application number: PCT/US1993/002868
Authority: WO
Inventors: Avram Grossman; Deirdre Merel
Original assignee: Homecare Diagnostic Services
Priority date: 1992-03-26
Filing date: 1993-03-25
Publication date: 1993-09-30
Also published as: AU4044393A

Abstract

Patient self-monitoring of a high-risk pregnancy using fetal heart and fetal movement monitoring uses a Doppler ultrasound transducer (100) in the determination of fetal heart rate and fetal movement. Additional maternal vital signs including uterine contractions and other physiological data which relate to the overall well being of the fetus and the mother are obtained using an actocardiograph (12) and physiological monitoring devices (13a-13e). Control of fetal heart rate monitoring is effected from a remote location (19) through a telephone network.

Description

FETAL MONITORING SYSTEM

BACKGROUND

This invention relates to patient medical, monitoring. In particular, this invention is directed to monitoring in an environment remote from a clinic. Health care of expectant mothers in the clinical and hospital environment includes, the monitoring of both uterine contraction (UC) and fetal heart rate (FHR). The use of ultrasound for fetal monitoring is approved by the Food and Drug Administration (FDA) in the clinical and hospital environment. Approval for use of fetal Doppler ultrasound in the patient self-monitoring environment has not however been approved for by the FDA.

Equipment for antepartum monitoring in the home, especially where the patient administers the test herself, performs only uterine contraction monitoring. The medical efficacy of UC monitoring alone without FHR and fetal movement monitoring remains a controversial issue within the medical community.

Prior art systems are limited to applications involving equipment for use in a hospital or clinical setting. For a high-risk pregnancy, this adds fetal and maternal stress for the commute to and from the hospital or clinic. The standard of care accepted by perinatologist are fetal recordings using Doppler ultrasound for detection of fetal heart rate and fetal movement (breathing) combined with the recording of pressure transducer detection of uterine contractions.

No prior art suggests technology or equipment which uses these electronic techniques accepted by medical practice for patient self-monitoring.

This invention seeks to provide a system which should meet the FDA requirements for use as a remote fetal Doppler ultrasound system.

SUMMARY

This invention includes the collection and transmission of data related to antepartum monitoring utilizing Doppler ultrasound fetal monitoring in patient self-monitoring in locations other than the clinical or hospital environment. According to the invention, monitoring fetal heart rate is effected by means for applying a signal to a maternal body. Sensor means detects a Doppler frequency shift of the signal as a measure of an ultrasound signal. This is effected at a first location which is remote from a control location. Control means at the control location regulates the application of the signal to the maternal body at least in frequency for a selected predetermined time period. The control location could be a hospital or physician's office. The first location could be a patient's home. The ultrasound signal is representative of the fetal heart rate and fetal movement, and interface means at the first location which receives the signal communicates the sensed signal to the remote location. Control means at the remote location receives the

communicated signal and controls through communication with the interface from the remote location. Preferably, the communication is effected by a cable network, which is a telephone network system.

Modems are applied to convert signals between the

interface to signals communicated on the cable, and signals from the cable to signals communicated to the control means, a visa versa.

Other devices may be also used to collect information pertaining to the health and well-being of the patient. This includes fetal monitoring, maternal EKG, blood pressure, blood glucose, body temperature and weight.

The invention is now further described with reference to the accompanying drawings.

DRAWINGS

Figure 1 is a diagram depicting the components of the system.

Figure 2 is a block diagram depicting the basic functional electronic elements contained within an the embodiment of the system. Figures 3a and 3b depict embodiments of the system. In Figure 3a, the monitoring devices are

connected to an actocardiograph unit through an interface cable 12a located on the back of the units. Figure 3b shows the component system integrated into an enclosure with the actocardiograph unit. Figure 4 is a flow chart depicting the overall firmware and software blocks as they are executed during an initial system power-up sequence.

Figure 5 is a flow chart depicting the application overview.

Figure 6 is a flow chart depicting the patient monitoring conditions.

Figure 7 is a flow chart depicting the Calling functions.

Figure 8 is a flow chart depicting the Place Calls function.

DESCRIPTION

Block 10 represents a first location, such as a patient's home, and shows the configuration of devices used by the maternal patient. Block 19 shows a typical configuration which functions at a first remote control location, namely the Diagnostic Center 19. A srandard Group III facsimile machine 18 is located in a hospital or physician's office, which can be a second remote control location. A plurality of monitoring devices 12, 13a through 13e are connected to the patient home monitor interface system for use by a patient at the convenient first location.

An interface device 11 is connected to an actocardiograph device, namely a Fetal Heart Monitor (FHM) or FM device for monitoring fetal status. Other optional physiological monitoring devices which include a blood glucose monitor 13a, a blood pressure monitor/heart rate monitor 13b, digital thermometer 13c, an electronic scale 13d, an EKG monitor 13e are also connected to the interface 11. Data sampled from acto'cardiograph 12 and monitors 13a, 13b, 13c, 13d and 13e are stored in memory during a recording session at the first location. The data is transferred to a mass storage device at the first location 10 upon completion of a recording session. A copy of that recording session is communicated and transferred via transceiver modems and a telephone cable network to the Diagnostic Center 19.

The Diagnostic Center 19 uses personal computer components 15 of either the DOS-based system type or Apple Macintosh system type computer. Software specific operates in the computer 15 to perform complex control and data transfer functions between the interface 11 and the computer 15. Transceivers at the first location and the diagnostic center includes telephone modem transfers. A standard computer data modem 14 is at the diagnostic center 19 and a similar modem is built into the interface 11. The information received from the patient monitoring system at location 10 is stored in a mass storage device 16, such as large-capacity hard disk drive or an optical disk drive 16 for archive purposes. Paper copies of. each patient's medical record are printed on a printing device capable of printing graphic images, such as a postscript-compatible type laser printer 17. Other computers, laser printers and mass storage devices 16 at the diagnostic center are connected using a Local Area Network (LAN) to form a network of multiple remote work stations terminals for sharing of data storage 16 and printing facilities 17.

An electronic image representation of the actocardiograph 12 output may be sent as a facsimile image to machine 18. The image is typically presented in a format that complies to an acceptable standard for fetal heart monitor charting paper and consists of two separate graphs side-by-side representing the measurement of fetal heart rate and uterine- contractions made over the recording session time period. The facsimile image of the recording session is transferred electronically via telephone modem from either the interface device 11 at the patient's location 10 or from a diagnostic center 19 directly to any standard Group III/ Class One

facsimile machine 18 in a hospital or physician's office.

The primary physiological monitoring device, actocardiograph 12 or FHM, is connected to the interface 11. The actocardiograph 12 is of the type that is approved by the FDA for use in the clinical and hospital environment. The actocardiograph is modified by the manufacturer according to specific requirements and has the ability to detect uterine contractions., fetal heart rate and fetal movement. The modifications involve first extending electric control signals in the actocardiograph 12 Doppler ultrasound circuit to interface connection 12a in such a manner that the generation of the Doppler signal may be inhibited externally by interface device 11. Second, a signal from the actocardiograph that indicates when the actocardiograph unit 12 has acquired a suitable FHR signal is extended to the interface connection 12a to the interface device 11. The actocardiograph 12 performs complex analysis of the appropriate input signals which are derived from pressure transducer and Doppler ultrasound transducer techniques. The UC, FHR and FM data is sampled and stored in system memory 31.

The technology employed to detect the UC signal is typically a pressure transducer 101 and related pressure transducer signal processing circuits. The technology employed to detect the FHR signal typically involves an ultrasound transducer 100 using Doppler frequency-shift signal processing techniques, although acoustic and electrocardiographic techniques have also been employed. The pressure transducer 101 is a passive device, namely detecting changes in pressure. The ultrasound device 100 operates by emitting a low-power (1.5mW/cm2 or less) l.lMhz frequency, and measuring the Doppler shift of that frequency against the moving fetal heart to determine the fetal heart rate.

The secondary physiological monitoring devices, such as a blood glucose monitor 13a, a blood pressure/ heart rate monitor 13b and other devices 13c , 13d and 13e are connected to the interface 11 through either of an appropriate analog input channel or standard serial interface (TTL or RS-232 signal types), depending upon the type selected for use.

Description of Interface

Figure 2 is a functional block diagram of the interface 11. The microprocessor 20 is the primary

"engine" controlling the flow of information in the system. The system is so designed to closely comply with an IBM-PC/XT bus architecture such that the integration of complex function electronic parts (VLSI) is accomplished using commercially available components. As a result, software development and testing for complex components is accomplished in a standard software

development environment using commercially available development tools. The microprocessor 20 uses a commercially available ROM-based Basic Input/Output System (BIOS) 21 that is configured to suit the hardware I/O design architecture specific for this invention. This BIOS 21 supplies the basic low-level control functions and acts as a software interface for higher-level programs. Low-level functions performed by the BIOS include memory management, real-time clock interrupt control, keyboard scanning, display scanning and control, disk access and power management functions. This BIOS 21 is of the type typically found in any personal computer architecture on the market today. It occupies space in a Read-only

Memory (ROM). A DOS-compatible Operation System (O/S) 22, provides the next highest level of functionality in the overall operating environment. The O/S provides a high degree of compatibility with existing personal computers and development environments. The O/S 22 may be transferred into RAM 24 upon power-up or may be executed from Program Read Only Memory or EPROM or FlashROM type storage chip. The O/S is a commercially available ROM DOS operating such as that available from Microsoft or Digital Research Corporation.

Mass data storage is accomplished by using a device such as a floppy disk drive unit 31. Recorded on floppy disks by the disk drive 31, a floppy disk is used to store and retrieve the various computer programs and for the storage of patient data. The storage device 31 is a 3.25 inch half-height floppy disk drive that can access floppy disks with a data storage capacity of up to 1.44 megabytes. This device offers a high capacity to low cost ratio as compared to other storage media types, such as silicon memory storage. The DOS operating system 22, main application program and patient information is distributed on a 1.44mB floppy disk which is inserted into disk drive 31. The floppy disk drive unit 31 may be replaced with a Personal Computer Memory Card (PCMC) compatible storage card. The external media controller 25 is an electronic circuit that provides an appropriate electrical interface signals between the external storage media device 31 and the XT bus architecture, and provides signals compatible with the Personal Computer Memory Card Industry Association specification for Release 2.0 type memory cards. The interface 11 incorporates a graphic-type liquid crystal display (LCD) 32 which serves to communicate information to the user. Information such as date and time, instructions and status of the various test and measurements are displayed. Graphic iconic characters are displayed in addition to English and/or Foreign language text, which serves to communicate messages, instructions and other information to the patient. The iconic characters may be animated in software to help convey particular information or instructions. The LCD is a super-twist pneumatic (STN) 256 by 128 dot graphic display with light emitting diode (LED) backlight. The display may also be an alphanumeric type in applications where graphics is not required. A 16-key keypad 37 permits the user to input specific information in response to specific message requests displayed on LCD 32. The keystrokes are

displayed on LCD 32 for the user to verify correct entry. The keypad 37 is also used to access certain software-based secure-access functions in the main program used for field test and update. The 16-key keypad may be replaced with a simple 2 or 4-key keypad when a numeric entry response system is not required by an application program. This simplification makes operation of the invention easier for the patient as the interface 11 may operate an application program sufficiently sophisticated that its operation does not require much user data entry or intervention. The connection of external physiological monitoring devices 13a, 13b, 13c, 13d and 13e is

accomplished through the instrument connection panel 34. This panel, which is mounted on the back of the interface device 11, is outfitted with small electrical connectors compatible and appropriate for interconnection with the desired third-party manufactured physiological monitors. Each individual connector is in turn wired to a multichannel analog-to-digital converter 27, or multi-channel digital I/O control 28 or a serial I/O controller 29. In an optional configuration, a selected single analog input is routed through a Digital Signal Processor VLSI chip 33. This DSP 33 performs specialized sophisticated signal processing functions as required by certain external physiological sensors.

Digital output signals in 28 provide control signals to the external physiological monitor as

necessary for the control of the fetal Doppler ultrasound, digital input signals in 28 provide control signals or information from the external physiological monitor as necessary. The A/D converter 27 samples analog signals from the appropriate physiological monitor and converts that analog signal to a digital representation for further processing by the processor 20. The A/D converter 27 is capable of sampling signals from eight different analog sources, or channels. The Digital I/O 28 is capable of input and output of eight each digital signals. The selection of A/D sample rate, and A/D and/or Digital I/O channel is controlled by software in the main program. To accommodate physiological monitors that use a standard RS-232 type interface method, the interface 11 is outfitted with multiple RS-232 interface circuits as appropriate to provide the interface. Data communications over the public switch telephone network (PSTN). is provided through the use of a modem VLSI circuit 30 which has been selected for

compatibility with the XT bus architecture. The VLSI circuit is of a modem type that provides fully integrated functions which includes the detection of dial tone, busy and ring signals from the telephone interface Direct Access Arrangement (DAA) 35 and both touch-tone and pulse dialing capability. The modem VLSI 30 supports standard IEEE V.32 and V.42 communication protocols which permit it to be used to communication with industry-standard Hayes-compatible modems and with Group III facsimile machines. The DAA 35 circuit meets FCC Part 15 for telephone line interconnection, and provides appropriate control and data signals between the switched public telephone network and the modem 30. The connection to the PSTN is through a standard RJ-11 telephone jack mounted on the back of the interface device 11.

Microprocessor controller 20, Liquid Crystal Graphics Controller 26, and keyboard interface 36 can be replaced by a single highly integrated chip microprocessor controller, along with other functions such as real-time clock, power management,, etc. Referring to Figure 3a, the interface 11 is built into an enclosure which permits it to be connected to any fetal monitor device which is modified to meet the interface and control requirements. Figure 3b shows the entire circuitry, disk drive, LCD display and keyboard integrated into a fetal monitor device when the fetaa monitor is built.

Operation of Interface

Referring to the flow chart Figure 4, when power is applied, the microprocessor 20 resets its internal program counter to an address where it begins executing microcode in the BIOS 21 at position 400.

Following conventional methods found in most standard Dps-compatible personal computers, the ROM BIOS 21 performs specific hardware setup and testing functions 401, then 402 loads the operating system from either Floppy disk 405 or ROM 406 and transfers program

execution the operating system. The Operating system (O/S), now executing from system RAM 24 provides high-level interface commands between the application and the ROM BIOS. The O/S, after being loaded into System RAM 24, will then load the main application program 403 into System Ram Figure 24 and transfer execution to it. A PC memory card sub-system may replace the floppy disk subsystem 405.

The main application program in flow chart Figure 5 provides the primary control and functional features of the interface 11. This program has a subroutine within its structure which facilitates replacement by another revision of itself. In this manner the main application program may be replaced/ updated through a controlled upload process during a telephone line connection to the diagnostic center 19.

Referring to the Application Overview flow chart in Figure 5, once the main application program is loaded, it performs certain reset and initialization functions 515, including to initialize the LCD controller circuit 26, calibration of the A/D converters 27, and loading the patient-specific parameters from the external storage media 31. Once the program has initialized the operating environment it need not be re-started again unless the unit has been powered off, or in the event of an unrecoverable error detected during normal operation 511 through 514.

The program begins to execute the main control loop 501 which incorporates a software-based state machine which is used to keep track of the return loop 503 flow for the sampling of the A/D converters, digital sampling, real-time clock sampling, and keyboard

sampling, and to determine the next function to proceed with based on the results of those samplings. As an example, the program may require the patient to enter in their body weight. While the patient is keying in each successive digit, the program loop will continue

performing any sampling in between each key stroke.

Referring to the monitor conditions flowchart in Figure 6, the control of the ultrasound emissions from the actocardiograph 12 are accomplished through a set of conditions which must be met. The comparison 603 of the time of day clock against a time period that is stored in a memory location, the software 621 enables the actocardiograph Doppler ultrasound 12 mechanism through a digital control output in 28, permitting the patient to perform a monitoring session.

A message is displayed on the graphics LCD 32 indicating that the actocardiograph 12 is available for a recording session. Once the patient correctly places the Doppler transducer 100 on herself and a consistent fetal heart signal is detected, the actocardiograph 12 sends a signal to the interface 11 via the communication connections signaling the start of a recording session 605. Acquisition and detection of a proper fetal heart signal is a feature of the actocardiograph 12.

When the 605 start signal is received, the interface 11 allocates memory in 610 for the temporary storage of incoming data and displays a message in 611. While the monitoring session is in progress 609, the device 11 samples the appropriate A/D channels, performs any necessary conversion calculations in 606, and stores the recording session data in continuous RAM memory. The duration of the recording session is tested in 607 and controlled by a lapse time value set in a memory

register. When the allotted recording duration has elapsed, the main program stops sampling the data, sends a signal to the actocardiograph 12, and then in 608 transfers the recording session data from RAM memory to a file on the external media (floppy disk). System files, also stored on the external media, are updated which includes a list of recording sessions which have not yet been sent to a diagnostic center 19. The ultrasound circuit in the actocardiograph 12 is disabled in 622 and the state machine flag is set in a memory register indicating that a recording session has been completed in 612 and the program returns to the main loop via 604. The requirement to perform any of the available selected external physiological monitoring functions is specified by the patients' prescribing physician and preset in the patient configuration file stored on a floppy disk. This file is opened during initialization 516 and the parameters stored in memory during the main program initialization process described above. Before the State machine transfers a completed recording session to the diagnostic center 19, the software checks to determine if each of the required tests have been performed by the patient in 614. If not, the software alerts the patient via a display in 616 that the test(s) must be conducted, and prompts her via the graphic LCD screen with instructions on how to perform the next required test until all tests have been completed. The tests include the monitoring of uterine contractions by sensor 101, the taking of patients body temperature using a digital thermometer, weighing herself on an electronic scale, the taking of a blood sample to perform a glucose level test, and others tests.

If the external physiological monitoring device is electrically connected to an input/output channel (s) of the invention, then the resulting datum from the test is electronically transferred through the interface 34, 27, 29, as appropriate in 617, and converted if necessary, and stored 618 in memory 24. In the event that an external physiological monitor, or other test, is not electrically connected to the invention for automatic input of the datum, then a message prompting the patient to manually enter the results via the keypad 37 is displayed.

When the main loop detects a State flag

indicating the completion of a recording session, and the conditions have been met for the recording of the

prescribed external physiological monitoring devices, the program switches operation to a sub-routine, shown in Figure 7 - Calling Functions, that performs the functions of dialing a pre-recorded telephone number of the Diagnostic Center, logging into the system, and exchanging control information, and data files.

The program first determines if a call is required in 701. Conditions which necessitate placing a call include the immediate completion of a recording session where the charts must be sent 703 or, if a previous call failed to connect with the diagnostic center 19. The device checks availability of the

telephone line, dials the diagnostic center 19 and logs into the system in 706. Any telephone dialing errors 708, such as phone line not available, Diagnostic Center line busy, or a disconnected call, is recorded. When the system determines that the current time-of-day does not meet the conditions to enable the ultrasound device (monitoring session not available), the patient may choose to "request special authorization" electronically in order to use the monitoring equipment outside of the prescribed time period. Authorization is requested when the patient presses a button on the front panel marked "Request Authorization." At that time the interface 11 places a call 709 to the authorizing

diagnostic center 19 and logs into the diagnostic center computer. An signal and display at the diagnostic center 19 alerts an attendant regarding the request. At that time the attendant may elect to "authorize" a monitoring session for that patient by selecting the authorization key. The diagnostic center computer sends an encoded message back to the interface 11 to either enable a monitoring session or to deny authorization in 710.

Instructions to the patient are also displayed explaining why authorization was not made, and requesting her to talk directly to the attendant via normal voice

telephone.

Details of a calling sequence is diagrammed in Figure 8 - Place Calls. When a "process call" condition is set in the appropriate monitor flags, the interface device 11 first enables the Fax Modem Controller 30 to go off-hook (acquire the telephone line). A feature of the Fax Modem Controller chip 30 will return a "dial-tone signal available" status to Microprocessor 20 when a dial-tone is present. If the dial-tone is not available, a retry-counter is incremented in 805 and a "telephone not available" message is displayed on LCD 32. Next, the selection of the telephone number to dial is determined in 802, and is based on prior dialing status. If the interface device 11 is sending charts from 703, then the primary data center telephone number is dialed. If the that number was recently dialed and resulted in no-connect condition, a secondary data center telephone number is tried. The selected telephone number is automatically dialed in 803. In the event that the call does not result in the detection of a modem carrier signal within a specified period of time 804, the

appropriate error counter is set in 805. When a modem carrier signal is detected by Fax Modem Controller 30, software in both the interface device 11 and data center computer 15 exchange a Logon protocol ID which identifies both devices as the appropriate receiver of information and appropriate sender of information. Upon successful completion of the Logon Process 806, basic system

parameters, such as time-of-day, remaining floppy disk storage capacity, and other information, is transfered and exchanged between the interface device 11 and the data center 15. When the basic information exchange is complete, the Place Calls sub-routine returns control to program from where it was called in 808 in order to complete patient information file transfer or request special authorization.

Brief Operation of the Diagnostic Center The diagnostic center system is based around a standard high-performance PC-AT personal computer

outfitted with multiple telephone modems. The main program or application is written to run in a Microsoft Windows environment. The application is divided into separate task programs, each with performs specific functions. These specific functions include auto-answering and processing the exchange of control information and data files of incoming calls, pre-processing and analysis of the incoming patient data files, auto-matic hard copy and archive functions of the incoming patient data, and the main patient record display

programs. Additional program tasks include the facsimile file conversion routines and Group III facsimile send routines, and other patient record management functions.

A call is received over the standard modem 14 under software control in the personal computer 15. A program task initiates a dialogue with the calling device as shown in flow chart Figure 7, 706 and 709. During the initial log on process, status and system clocks are compared and updated if necessary. Upon successful log on procedure, the invention will transfer patient charts to 15 as show in process 707. Any previously unsent charts are also sent at that time. Once the patient charts have been received, software in 15 electronically analyzes the contents of the data. Comparing the results of the analysis against the threshold limits set in the patient data file, any datum not within the limits specified for that particular patient, a special notification message will alert the attendant at the diagnostic center 19 to this condition immediately. In the case where the tested datum is within limits for that particular patient, the received patient chart is printed on the laser printer 17,

providing a hard-copy record for the patient files. The electronic image file is placed in an electronic in-basket for viewing by the attendant on a first-in, first-out basis.

Along with providing a graphical image representation of the fetal heart monitor chart recording displayed on a high-resolution color graphics monitor, the personal computer 15 acts to provide the Doppler ultrasound control interface.

This invention offers important advantages to the health care provider of a high-risk pregnancy by

(a) providing essential information related to the physiological condition of the fetus;

(b) providing important information related to the physiological condition of the expectant mother;

(c) providing a method of collecting physiological parameters related to both the fetus and expectant mother in one database system;

(d) providing a method of transferring the fetal and maternal information to a Diagnostic center in a timely manner where the information may be (i) electronically; and (ii) manually evaluated by a trained ciinician/nurse/physician for the early detection of potential problem conditions related to the status of the pregnancy; and

(e) providing a method of using Doppler ultrasound monitoring outside of the clinical environment by a patient in an manner acceptable to the FDA.

Many other forms of the invention exist, each differing from the other in matters of detail only. The inventions is to be determined solely by the following claims.

Claims

1. Apparatus for monitoring fetal heart rate comprising, at a first location, means for applying a signal to a maternal patient, sensor means for detecting an ultrasound response of the signal representative of the fetal heart rate of a fetus within the patient, interface means for receiving the detected ultrasound signal from the sensor means, and first transceiver means for communicating the sensed signal to control means at a location remote from the interface, the control means including transceiver means for receiving the sensed signal and for communicating control signals to the interface for controlling operation of the interface means.

2. Apparatus as claimed in claim 1 including means for sensing uterine contraction of the patient.

3. Apparatus as claimed in claim 1 including means for selectively sensing maternal physiological characteristics being selectively at least one of EKG, blood pressure, blood glucose, body temperature and weight.

4. Apparatus as claimed in claim 2 including means for selectively sensing maternal physiological characteristics being selectively at least one of EKG, blood pressure, blood glucose, body temperature and weight.

5. Apparatus as claimed in claim 1 including means for communicating through a cable network, and modem means at the interface and modem means with the control means for converting signals respectively from the interface and signals from the control means to signals transmittable on the cable network.

6. Apparatus as claimed in claim 2 including means for communicating through a cable network, and modem means at the interface and modem means with the control means for converting signals respectively from the interface and signals from the control means to signals transmittable on the cable network.

7. Apparatus as claimed in claim 4 including means for communicating through a cable network, and modem means at the interface and modem means with the control means for converting signals respectively from the interface and signals from the control means to signals transmittable on the cable network.

8. Apparatus as claimed in claim 1 wherein the control means includes at least one of a computer, fax, printer or data storage means.

9. Apparatus as claimed in claim 2 wherein the control means includes at least one of a computer, fax, printer or data storage means.

10. Apparatus as claimed in claim 4 wherein the control means includes at least one of a computer, fax, printer or data storage means.

11. Apparatus as claimed in claim 1 wherein the interface means includes keyboard means, a keyboard interface and a microprocessor controller, whereby the keyboard is operable in the patient to interact selectively with the interface and the control means.

12. Apparatus as claimed in claim 2 wherein the interface means includes keyboard means, a keyboard, interface and a microprocessor controller, whereby the keyboard is operable in the patient to interact selectively with the interface and the control means.

13. Apparatus as claimed in claim 1 wherein the control means includes means for selectively

controlling at least one of the time duration of applying an ultrasound signal in at least one predetermined time period, means for altering parameters of ultrasound signal application, and means for overriding selected preset parameters in the interface for permitting use of the signal producing means.

14. Apparatus as claimed in claim 2 wherein the control means includes means for selectively

15. A method for monitoring the fetal heart rate comprising, at a first location, applying a signal to a maternal patient for determining fetal heart rate, sensing an ultrasound response of the signal as

representative of the fetal heart rate, transmitting the detected ultrasound siσnal to an interface, communicating the signal to a control remotely located from the

interface, and controlling the operation of the signal application from the control and reading ultrasound signals remotely from the location where the signal is applied.

16. A method as claimed in claim 15 including sensing uterine contractions.

17. A method as claimed in claim 15 including sensing selected other physiological characteristics of the body.

18. A method as claimed in claim 16 including sensing selected other physiological characteristics of the body.

19. A method as claimed in claim 15 including communicating between the first location and the remote location through a cable network having modems.

20. A method as claimed in claim 15 including selectively controlling the ultrasound application from the remote location by a computer program, selectively storing and obtaining data from the first location via facsimile or printer means,. selectively inputting stored data related to the patient.

21. A method as claimed in claim 15 including keying instructions and information into the interface at the first location thereby to control the ultrasound sensing and communication with the remote control.