1. Field of the Invention
This invention relates generally to implantable devices, such as cardiac stimulators, designed to be situated within a living body and to exchange information with devices located outside the body. More particularly, the invention relates to a novel technique for processing and exchanging data between an implantable device and a remote device which makes efficient use of power and signal processing capabilities within the implantable device.
2. Description of the Related Art
In recent years increasingly sophisticated systems have been developed for monitoring and controlling certain physiological processes via implanted devices. Such devices are typically placed within a patient's body and remain resident within the patient's body over extended periods of time. One such device, commonly referred to as a cardiac stimulator, is commonly implanted in a patient's chest region and includes circuitry both for monitoring the functioning of the patient's heart as well as for providing stimulus for the heart when needed.
Conventional implantable cardiac stimulators include one or more electrical leads which extend between electronic circuitry provided within the device housing and portions of the patient's heart. For example, leads extending from the stimulator may be terminated in the right atrium and right ventricle of the patient's heart to provide both sensing and stimulation capabilities. The circuitry is programmed to execute desired functions, such as monitoring, stimulating, and storing of diagnostic or other data. A power supply is implanted with the device to furnish the electrical energy needed for its operation.
Through their relatively short history, cardiac stimulators and other implantable devices have experienced very considerable evolution. For example, early cardiac stimulators provided fixed rate stimulating pulses designed to regulate the patient's heart beat only. Later designs, sometimes referred to as “demand” pacemakers, also offered heart monitoring capabilities, providing stimulating pulses only as needed based upon the monitored functioning of the heart. Further improvements in cardiac stimulators included programmable rate pacemakers, dual chamber pacemakers, and “rate-responsive” pacemakers, each providing increased flexibility and adaptability of the monitoring and stimulation functions to more closely conform to the needs and physiological parameters of the patient, such as the patient's level of physical activity.
Throughout the evolution of cardiac stimulators and other implantable devices, a persistent problem has been the efficient provision and use of electrical energy. In general, the power source, typically including a specially designed electric battery, is implanted with the electronic circuitry to provide all power necessary for the monitoring, stimulation, programming and other functions of the implantable device over extended periods of time, often measured in years or decades. To provide the longest possible life to the implanted power source, therefore, it is generally a goal in the design of such devices to reduce the power needed for all aspects of their function. For example, the replacement of early fixed rate pacemakers with demand pacemakers significantly reduced the energy continuously dispensed by the device by generating stimulating signals only as needed, thereby prolonging the effective life of the power source. Other developments have also extended the useful life of such power sources, although further improvements are still needed.
A particularly useful function of implantable devices involves the ability to transmit and to receive information between the implantable device and an outside programming or monitoring unit. Data exchange between the implantable device and the external unit permits parameters, such as physiological data, operational data, diagnostic data, and so forth, to be transmitted from the implantable device to a receiver from which the data can be accessed and further processed for use by an attending physician. The data is particularly useful for gaining insight into the operation of the implantable device as well as the state of the patient's organs and tissues. The ability to exchange data in this manner also permits the physician to reprogram or reconfigure the implantable device as may be required from time to time due to evolution of the patient's condition.
Data exchange between an implantable device and a remote, outside device is often accomplished by “waveform telemetry” in which the data is conveyed through the patient's tissue and skin. Early waveform telemetry systems employed in implantable cardiac stimulators transmitted signals through analog encoding. For example, in one known type of pacemaker, analog samples representing operational or physiological parameters are transmitted as the pulse position of a radio-frequency pulse train. The pulse train is output by either the implantable device or the outside device, and is interpreted or decoded upon receipt by the other device. While such techniques are extremely useful for gaining access to information relating the performance of the patient's organs and of the implantable device, analog telemetry circuits typically yield low resolution and often AC-coupled and uncalibrated signals, effectively limiting their utility and reliability.
To address the shortcomings of analog telemetry systems, digital telemetry schemes have been developed. For example, certain digital telemetry systems are presently in use wherein a radio-frequency carrier or radio-frequency pulse train is modulated by digital information corresponding to samples of the analog signals to be telemetered. Such digital data communication methods make use of an analog-to-digital (A/D) converter for transforming samples of analog signals into digital format for transmission. If multiple analog signals are to be transmitted, an analog signal multiplexer is employed to select one signal at a time to feed to the A/D converter. A programmer or a telemetry system controller selects the channel from which the next sample is to be converted prior to transmission. However, such processing reduces the sampling rate per signal due to the relatively large portion of time and telemetry channel bandwidth which must be used for communicating the channel information. Moreover, a relatively fast A/D converter is required because the telemetry system must wait for the conversion to be completed before being able to transmit the data. The use of a fast A/D converter results in considerable energy usage, reducing the effective life of the implantable power source.
Alternatively, a predetermined data acquisition sequence may be established to eliminate the need for continuously communicating the channel to be converted. This alternative, however, limits the flexibility of the system as the number and identity of channels to be transmitted generally cannot be changed without first reconfiguring the sequencer. Moreover, this technique requires the sampling process to be synchronized with read operations executed by the telemetry circuit, as asynchronous operation may yield transmission or reception of invalid or misinterpreted data.
There is a need, therefore, for an improved technique for exchanging data between an implantable device and a device external to a patient's body. There is a particular need for a telemetry technique which is capable of transmitting digitized data to and from an implantable device, but which avoids certain of the drawbacks of existing systems as summarized above.
The present invention provides a novel technique designed to respond to these needs. The technique permits the exchange of information between an implantable device and an external device, and the conversion of analog information to digital information according to and at rates adapted to conform to the needs and desires of a user of the external device, typically an attending physician. The telemetry technique enables the effective transmission of analog signals, such as intracardiac electrograms, intracardiac and spacial impedance signals from the implantable device to an external device via high speed digital telemetry. In an advantageous configuration, the technique employs dedicated registers in the implantable device for storing data corresponding to digitized values of analog signals associated with the registers. The contents of the registers may be telemetered to the external device upon demand. In a preferred arrangement, the contents of the registers are updated automatically each time the register is read, refreshing the stored data contained in the register as a function of the read requests received from the external device. The A/D conversion process, its sequence and its speed are advantageously determined by the requests of the external device in real time, providing enhanced flexibility and reduced energy consumption, while offering the attending physician the most up-to-date information on the specific information desired to be accessed.
Thus, in accordance with a first aspect of the invention, a data telemetry system is provided for transmitting signals from an implantable device to a remote external device. The implantable device is configured to collect data representative of at least first and second operational parameters of the implantable device or a biological system in which the implantable device is disposed. The telemetry system includes first and second memory circuits, a telemetry circuit, and a control circuit. The memory circuits allow for storage of values representative of the first and second parameters, respectively. The telemetry circuit is coupled to the first and second memory circuits, and is configured to transmit first and second signals representative of the first and second values. The signals transmitted by the telemetry circuit are in response to transmission request signals from the remote device. The control circuit is coupled to the first and second memory circuits and is configured to control replacement of the first and second values in the first and second memory circuits in response to transmission of the respective first and second signals. An analog-to-digital conversion circuit is advantageously coupled to the first and second memory circuits and converts analog signals to the first and second values in response to transmission of the corresponding value via the telemetry circuit. A switching circuit may be provided for applying analog signals to the conversion circuit as the first and second values are telemetered.
In accordance with another aspect of the invention, an implantable device is provided which is configured to be disposed in a living body. The device includes a signal processing circuit, a signal conversion circuit, memory circuits, a telemetry circuit, and a control circuit. The signal processing circuit detects at least two operational parameters of the device or the body, and generates analog parameter signals representative thereof. The signal conversion circuit is coupled to the signal processing circuit for converting the analog parameter signals to digitized parameter values. The memory circuits store the digitized parameter values produced by the conversion circuit. The telemetry circuit transmits signals representative of the digitized parameter values in response to request signals received from an external unit. The control circuit is coupled to the signal processing circuit and is configured to apply analog parameter signals to the conversion circuit in response to transmission of the digitized values. The control circuit may advantageously control the conductive state of switches in a switching circuit for selectively applying the analog parameter signals to the conversion circuit in coordination with the telemetry of the digitized values.
In accordance with still another aspect of the invention, a system is provided for telemetering digital data from an implantable medical device to an external device. The system includes a data acquisition circuit, an analog-to-digital converter, a telemetry circuit, and a control circuit. The data acquisition circuit is configured to generate analog parameter signals representative of operational parameters of the implantable device or a body in which the implantable device is disposed. The analog-to-digital converter is coupled to the data acquisition circuit for converting the analog signals to digital values. The telemetry circuit transmits digital values produced by the converter to the external device in response to request signals from the external device. The control circuit selectively applies the analog signals to the converter. The digital values are thus telemetered to the external device in a sequence and at a rate defined by the request signals in real time.
The invention also provides a method for transmitting data between an implantable device configured to be disposed in a living body and an external device disposed outside the body. In accordance with the method, first and second analog parameter signals are generated which are representative of operational parameters of the body or of the implantable device. The analog parameter signals are converted to digital values, and the digital values are stored in a memory circuit. One of the digital parameter values is telemetered to the external device in response to a request signal from the external device. The analog parameter signal corresponding to the telemetered parameter value is then converted to an updated digital value. The telemetered parameter value is then replaced in the memory circuit with the updated digital value.
In accordance with a further aspect of the invention, a method is provided for acquiring data representative of cardiac function. The method includes the steps of monitoring a plurality of parameters representative of cardiac function in an implantable device, and generating analog parameter signals representative thereof. The analog parameter signals are converted to respective digital parameter values. The digital parameter values are stored in a memory circuit. A desired digital parameter value is telemetered to an external device in response to a request signal from the external device. The analog parameter value corresponding to the desired digital parameter value is then converted to an updated digital value, and the desired digital parameter value is replaced in the memory circuit with the updated digital value. The analog parameter signals may be derived from sensed signals, such as in a dedicated signal processing circuit. The method may be repeated to obtain effective sampling rates for the parameters as defined by the request signals from the external device. Sampling rates may be different for different parameters depending upon the particular parameter of interest and the rate of sampling required for obtaining meaningful information on the parameter.
In accordance with still another aspect of the invention, a method is provided for telemetering digital data from an implantable medical device to an external device. According to the method, analog signals are generated which are representative of operational parameters of the implantable device or a body in which the implantable device is dispose. A series of data request signals are transmitted from an external device to the implantable device. The data request signals define a sequence of desired samples of the operational parameters. The analog signals are processed in the implantable device to convert analog signals corresponding to the desired samples to digital values and to telemeter the digital values to the external device in response to the data request signals. The data request signals may advantageously establish effective sampling rates for specific parameters of interest, depending upon the nature of the parameter, and the sampling rate required to obtain meaningful information on them.
The foregoing and other advantages and features of the invention will become apparent upon reading the following detailed description and upon reference to the drawings in which:
Turning now to the drawings, and referring first to
Implantable device 10 includes data acquisition, processing and telemetry circuitry housed within a case or enclosure 18. Enclosure 18 is sealed to isolate the circuitry from surrounding tissues and body fluids following implantation. Leads 20 and 22 are interconnected with the circuitry within enclosure 18 and extend to sensing points within body 14. In the case of the cardiac stimulator illustrated in the Figures, leads 20 and 22 are coupled to desired points within the heart 24 of the patient. In particular, a terminal end 26 of lead 22 is secured within the right atrium 28 of the patient's heart, while a terminal end 30 of lead 20 is secured within the right ventricle 32 of the patient's heart. As will be appreciated by those skilled in the art, leads 20 and 22 are generally flexible assemblies including an electrically conductive core surrounded by a protected sheath. For example, the internal core may be coiled titanium wire, and the protective sheath may be a coating of polyurethane. Once secured within the respective portions of the patient's heart, tips 26 and 30 permit parameters representative of cardiac function to be sensed via signals transmitted through the leads to circuitry within enclosure 18. Moreover, circuitry is provided within device 10 for stimulating portions of the heart via leads 20 and 22 in a manner generally known in the art.
It should be noted that, while throughout the present discussion reference is made to data acquisition, processing and telemetry techniques as applied to a cardiac stimulator, the techniques may find application outside the realm of cardiac devices. In particular, signals monitored, processed and telemetered by implantable device 10 could be related to the state and function of other biological systems within body 14, including organs and tissue other than the heart.
Once implanted within body 14, device 10 executes predetermined monitoring and control functions as required by the particular condition of the patient. Signals monitored by device 10 may be accessed by external device 12 via an antenna 34. For monitoring, antenna 34 is placed adjacent to the patient's body in the general vicinity of enclosure 18. Antenna 34 is coupled via flexible conductors 36 to a base unit 38, commonly referred to as a programmer. Programmer 38 permits a user, typically an attending physician, to access information sensed and processed by implantable device 10 via antenna 34 and conductors 36.
The functions executed by implantable device 10 are accomplished via electronic circuitry housed within enclosure 18.
Referring now more particularly to the functional electronic circuitry illustrated in
Signals processed by circuit 52 are available for further processing and telemetry to external device 12 as follows. Signals of interest processed by circuit 52 are applied to a switching circuit 54. Switching circuit 54 includes a plurality of solid state switching devices, the conductive state of which is controlled by a telemetry and analog-to-digital (A/D) logic circuit 56. Circuit 56 configures switching circuit 54 to open and close switches within circuit 54 to apply desired signals from data acquisition and processing circuit 52 to an A/D conversion circuit 58. Analog signals from circuit 52 applied to A/D conversion circuit 58 are converted to corresponding digital values. These corresponding digital values are stored in a memory circuit 60. As described below, the advantageous configuration of circuit 52, 54, 56, 58 and 60 permits specific analog signals of interest to be converted from monitored analog waveforms to digital values so as to update memory locations within circuit 60 in response to information requests received from external device 12.
Digitized values stored within memory circuit 60 are available for transmission to external device 12 via a telemetry circuit 62. Telemetry circuit 62 receives command signals from a microprocessor 64. In addition to commanding operation of telemetry circuit 62, microprocessor 64 receives and processes various signals from other functional circuitry related to the continuous monitoring and stimulating functions of implantable device 10. In particular, in the illustrated embodiment microprocessor 64 is coupled to an activity sensor 66, a ventricular-to-atrial interval timer circuit 68, an atrial-to-ventricular interval timer circuit 70, a memory circuit 72, and a general purpose A/D circuit 74. The configuration and operation of circuits 66 through 74 are generally known in the art. For example, activity sensor 66 may include an accelerometer which detects movement of the patient in which implantable device 10 is disposed. Signals from activity sensor 66 are typically used by microprocessor 64 as a rate-responsive input, allowing microprocessor 64 to adapt its monitoring and stimulation functions in accordance with the patient's changing activity level. Timer circuits 68 and 70 receive clock pulses from microprocessor 64 and serve to count or indicate intervals between contractions of tissues within heart 24. Memory circuit 72 serves to store the control routine executed by microprocessor 64, as well as data acquired by or processed by microprocessor 64. In particular, memory circuit 72 may store diagnostic and programming data which may be preconfigured prior to implantation of device 10, or which may be conveyed to device 10 by telemetry after implantation. Finally, general purpose A/D circuit 74 permits microprocessor 64 to obtain digital values of various functional parameters in the execution of its monitoring and control routines. In general, A/D circuit 74 is employed for more slowly changing parameter values, such as lead impedance, battery condition, and so forth.
It should be noted that implantable device 10 may include circuitry which is different from or complimentary to the circuitry illustrated in FIG. 2 and described above. In particular, as will be appreciated by those skilled in the art, device 10 includes a power supply (not shown) which furnishes a continuous source of electrical energy needed for operation of the functional circuitry. The power supply will typically include a power storage battery, such as a lithium iodide or lithium carbon monofloride battery. Where desired, the power supply circuitry may also include a voltage regulator for converting the voltage from the battery to a desired level as required by the functional circuitry.
In operation, implantable device 10 is configured to detect analog waveforms via leads 20 and 22 on a continual basis. The analog waveforms are applied to signal acquisition and processing circuit 52, and therethrough to switching circuit 54. Certain of the signals processed by circuit 52 may be applied directly to microprocessor 64. For example, in the illustrated embodiment, single-bit digitized signals are applied to microprocessor 64 directly from circuit 52 to indicate to the microprocessor that a chamber signal (typically corresponding to a tissue contraction), has been detected. Microprocessor 64 functions to monitor these signals as well as signals from circuits 66, 68, 70, 72 and 74. As a function of these signals and of the routine stored within memory circuit 72, microprocessor 64 triggers atrial and ventricular stimulus generator circuits 48 and 50 to provide pulses to heart 24 as needed to regulate its function.
As mentioned above, circuitry within implantable device 10 permits signals monitored by the device to be accessed and telemetered to external device 12 upon demand.
Signals produced by circuits 76, 78, 80, 82 and 84 are further processed in signal acquisition and processing circuit 52, and made available for conversion to digitized values. In particular, signals from atrial sense amplifier 76 and ventricular sense amplifier 78 are applied to a switch bank 86 which includes a plurality of solid state switching devices. The switching devices of switch bank 86 may be opened and closed to apply signals available from circuits 76 and 78 to programmable gain amplifiers 88 and 90. As described more fully below, the conductive states of the switches of switch bank 86, and the gains of amplifiers 88 and 90 are defined by microprocessor 64 (see FIG. 2).
Signals produced by IEGM amplifiers 80 and 82 are further processed by an adder circuit 92. In particular, the signal output by IEGM amplifier 80 is applied to one input node of adder 92, while the signal output by IEGM amplifier 82 is applied to a pair of input node switches 94. Switches 94 may be opened and closed under the direction of microprocessor 64 (see
The signals produced and processed by the foregoing circuitry are available for conversion to digitized values via output conductors 96, 98, 100, 102, 104 and 106. In the illustrated embodiment, first and second output conductors 96 and 98 are coupled to programmable gain amplifiers 88 and 90, respectively. A third output conductor 100 is coupled to directly to the output of IEGM amplifier 80. A fourth output conductor 102 is coupled to the output node of adder 92. A fifth output conductor 104 is coupled directly to the output of IEGM amplifier 82. Finally, a sixth output conductor 106 carries the signal produced by impedance sensor 84.
Referring now to the specific circuit configurations illustrated in
In addition to the filtering circuitry described above, each sense amplifier 76 and 78 includes an evoked potential detector 118. The evoked potential detectors receive the raw output from operational amplifiers 108 and produce signals available via additional switches within switch bank 86. As will be appreciated by those skilled in the art, evoked potential detectors 118 are configured to detect signals within a very short time delay after a pacing pulse from stimulus generating circuits 48 and 50. Outputs of the evoked potential detectors serve to indicate whether such pacing pulses were able to capture the chambers of the heart stimulated by the pulses. Thus, the evoked potential detectors amplify the signals produced by operational amplifiers 108 very rapidly after pacing pulses, filtering the signal to verify chamber capture. Such verification may be used to regulate further stimulation pulses and thereby to avoid unnecessarily draining the implanted power source.
Circuits 76 and 78 also include programmable threshold-crossing comparators 120 which produce pulses if the outputs from high pass filters 116 exceed predetermined thresholds. As will be appreciated by those skilled in the art, signals produced by comparators 120 serve to indicate whether a chamber signal has been detected. Signals from comparators 120 are applied directly to microprocessor 64.
IEGM amplifiers 80 and 82 also include filtering and amplification circuitry as shown in FIG. 3. Each amplifier circuit thus includes an operational amplifier 122 which is coupled to the ring anode conductor within leads 20 and 22, and to enclosure 18. Signals output by operational amplifiers 122 are filtered through low pass filters 124 and high pass filters 126. Output signals from high pass filters 126 are amplified in programmable gain amplifiers 128. The signals are then output to third and fifth output conductors 100 and 104, and are applied to adder 92 as summarized above.
In the illustrated embodiment, certain of the settings used by the circuitry of
Signals produced and processed by the circuitry of
Digital signals produced by A/D conversion circuit 58 are stored in a series of registers within memory circuit 60. In particular, the digital values are output from A/D conversion circuit 58 via an A/D output bus 138. Bus 138 is coupled to a series of registers 140 (denoted REG 1-REG 6 in
As mentioned above, external device or programmer 12 is configured to permit a programmer, typically an attending physician, to access information stored in registers 140. As illustrated diagrammatically in
Telemetry circuit 62 and telemetry interface circuit 144 are preferably configured to exchange data via magnetic fields which extend through tissue 16 partially surrounding device 10. While various signal transmission protocols may be envisioned and employed for implementing the present data acquisition and telemetry technique, a presently preferred method is disclosed in U.S. Pat. No. 5,383,912 issued on Jan. 24, 1995 to Cox et al., and U.S. Pat. No. 5,480,415 issued on Jan. 2, 1996, also to Cox et al. Both of the foregoing patents are assigned to the assignee of the present invention and are hereby incorporated into the present disclosure by reference.
Digitized parameter values stored within memory circuit 60 are telemetered to external device 12 in response to request or prompt signals received from the external device.
With the acquisition configuration thus set, external device 12 telemeters data request signals as desired by the attending physician. The request signals are received by telemetry circuit 62, prompting telemetry circuit 62 to access the requested values stored in memory registers (see registers 1 through 6 in
This control logic, designated generally by reference numeral 150, is summarized in FIG. 5. As indicated in
At step 158 circuit 56 verifies whether A/D conversion circuit 58 is available for converting an additional analog signal to a digital value. The circuit logic continues to loop back through this inquiry until A/D conversion circuit 58 becomes available. Once the circuit is available, logic circuit 56 changes the conductive states of selection switches 130 (see
As will appreciated by those skilled in the art, the foregoing technique offers a number of significant advantages over existing data acquisition and telemetry schemes. For example, logic circuit 56 will apply analog signals to A/D conversion circuit 58 in a manner and sequence conforming to the specific needs and requests of the external device. Moreover, only the parameters of interest to the attending physician will be converted and telemetered, thereby reducing the power consumed by the device and more efficiently utilizing the signal processing capabilities and telemetry bandwidth.
By way of example, an attending physician may set an acquisition configuration to obtain filtered IEGM data and impedance sense data only. In the acquisition configuration, then, switches in switch bank 86 (see
Another advantage afforded by the present technique is the ability to set and change the sequence and sampling rate for particular parameters in real time by the request signals received from the external device. In particular, because meaningful information regarding particular parameters may require different sampling rates, external device 12 may be configured to request digitized values of changing analog waveforms in different sampling frequencies depending upon the particular parameter. Moreover, certain of the sensed parameters may change at speeds permitting relatively slow sampling rates, while other parameters require extremely high sampling rates to obtain meaningful information. For example, data request signals prompting telemetry of digital values corresponding to the output of impedance sensor 84 may be sent at a frequency resulting in a sampling rate on the order of 100 to 150 samples per second. Filtered IEGM data may be requested and telemetered at a higher rate, such as of on the order of 200 to 300 samples per second. Other IEGM data may be sampled on the order of 400 to 500 samples per second. Very wide band IEGM data may require much higher sampling rates, such as on the order of 1000 to 3000 samples per second.
Such different sampling rates can be readily accommodated by the present technique. Request signals are assimilated into an appropriate string defining both the parameters to be converted and telemetered, as well as the resulting sampling rate. By changing the request signal string, the attending physician may, in real time, access different information or alter the effective sampling rate of the accessed information. To accommodate very high sampling rates, A/D conversion circuit 58 is preferably selected so as to permit the necessary conversion of any particular analog signal to a digitized value at least as fast as the highest anticipated sampling rate. That is, A/D conversion circuit 58 is conveniently selected to provide an A/D conversion time approximately equal to or faster than the telemetry time anticipated.
As noted above, while the foregoing technique has been described in the context of a cardiac stimulator, in appropriate devices, it may be employed for providing information relating to other tissues and organs. Moreover, parameters in addition to those described above may be accessed, processed and telemetered in accordance with the foregoing technique. In particular, in a cardiac stimulator, other possible signal sources include implanted pressure sensors, such as transducers configured to generate signals indicative of intracardiac pressure. Moreover, signals may be processed from such sources as peak endocardial accelerometers, for providing an indication of global contractility of the heart as a function of a signal amplitude.
While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.
This application is a continuation under 37 CFR 1.53(b) of Ser. No. 09/369,068 filed Aug. 5, 1999, now U.S. Pat. No. 6,507,759 which is a continuation of Ser. No. 09/020,278 filed Feb. 6, 1998 (now U.S. Pat. No. 5,978,713), which applications are incorporated herein by reference.
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Number | Date | Country | |
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Parent | 09369068 | Aug 1999 | US |
Child | 10302587 | US | |
Parent | 09020278 | Feb 1998 | US |
Child | 09369068 | US |