Medical management system integrated programming apparatus...

Surgery: light – thermal – and electrical application – Light – thermal – and electrical application – Electrical therapeutic systems

Reexamination Certificate

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Details

C607S032000

Reexamination Certificate

active

06477424

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to implantable medical devices. More particularly, the present invention pertains to apparatus and methods for use in the communication of information to/from an implantable medical device, e.g., programming commands, diagnostic information, etc.
BACKGROUND OF THE INVENTION
Communication systems employing radio frequency (RF) transmitters and receivers are common. One application of such communication systems is in the field of body implantable medical devices, such as pacemakers, defibrillators, neural stimulators, and the like. RF communication is used to establish “downlink” telemetry channels, in which operational data and commands are transmitted from an external programming unit transmitter to a receiver in an implanted medical device, and/or is used to establish “uplink” telemetry channels, in which information is transmitted from the implanted medical device's transmitter to a receiver in the external unit.
A specific example of a particular component of a telemetry system for implantable medical devices is the Medtronic Model 9790 programmer, commercially available from Medtronic, Inc., the assignee of the present invention. The Model 9790 programmer, with appropriate software modules, can be used to communicate (both uplink and downlink) with numerous body implanted devices manufactured by Medtronic, Inc.
Conventionally, as exemplified by the Model 9790 programmer in conjunction with a Medtronic implantable medical device (e.g., a pacemaker), an antenna in the form of a multiple turn wire coil is disposed within the hermetic enclosure of the implanted medical device. Downlink RF signals transmitted to the implanted device from an external unit induce a current in the coil antenna, and this current is amplified and applied to a receiver input for demodulation and extraction of the information content of the RF signal. Similarly, for uplink communication, electrical current applied directly to the implanted coil antenna, cause RF electromagnetic signals to be generated. Such signals can be received by a corresponding antenna associated with the external unit.
For various reasons, including the desire to minimize the necessary strength of both uplink and downlink telemetry signals in implantable medical device systems, the external unit, e.g., programmer, of an implantable medical device system typically includes a relatively small, hand-held programming head containing an external antenna, so that this programming head can be placed directly over the implant site of the implanted device. This minimizes the distance between the implanted antenna associated with the implanted device and the external antenna associated with the programmer. For example, the head is typically connected to a larger base unit of a programmer via a multiple conductor cable. The aforementioned Model 9790 is one example of an implantable device programmer having this configuration. The Model 9790 is described in further detail in U.S. Pat. No. 5,345,362 to Winkler et al., entitled “Portable Computer Apparatus With Articulating Display Panel.” Further, a programming head and cable for use with such an implanted device programmer is described in U.S. Pat. No. 5,527,348 to Winkler et al., entitled “Magnetically Permeable E-Shield And A Method Of Connection Thereto.”
Various communication systems provide the necessary uplink and downlink communication channels between an external unit, e.g., programmer and the implanted medical device. However, some communication systems do not require the use of a hand-held programming head containing the external antenna. For example, such a communication system is described in U.S. Pat. No. 5,683,432 to Goedeke et al., entitled, “Adaptive, Performance-Optimizing Communication System For Communicating With An Implanted Medical Device.”
As the complexity of implantable medical devices increases over time, communication systems for enabling such implantable medical devices to communicate with external communication devices, e.g., programmers, has become more important. For example, it is desirable for a physician to non-invasively exercise some amount of control over the implanted medical device, e.g., to turn the device on or off after implantation, to adjust various parameters of the implantable medical device after implantation, etc.
Further, as implantable medical devices include more advanced features, it is typically necessary to convey correspondingly more information to the implantable medical device relating to the selection and control of such advanced features. For example, not only is a pacemaker selectively operable in various pacing modes, it is desirable that the physician be able to non-invasively select a mode of operation. Further, for example, if a pacemaker is capable of pacing at various rates or of delivering stimulating pulses of varying energy levels, it is desirable that the physician be able to select, on a patient-by-patient basis, appropriate values for such variable operational parameters. Various types of information are conveyed to implanted medical devices by telemetry systems. For example, information conveyed to pacemakers may include, but is clearly not limited to, pacing modes, multiple rate response settings, electrode polarity, maximum and minimum pacing rates, output energy such as output pulse width and/or output current, sense amplifier sensitivity, refractory periods, and calibration information.
Not only has the complexity of implantable medical devices led to the need to convey correspondingly more information to the implantable medical device, but it has also become desirable to enable the implanted medical device to communicate a large amount of information outside of the patient to an external communication device, e.g., programmer. For example, for diagnostic purposes, it is desirable for the implanted device to be able to provide information regarding its operational status to the physician. Further, various implantable medical devices are available which transmit information to an external communication device such as digitized physiological parameter signals, e.g., ECG, for display, storage, and/or analysis by the external communication unit. Generally, such information conveyed from the implanted medical device includes any type of diagnostic information and/or information relating to the physiological parameters of the patient in which the device is implanted.
Substantial technological improvements in the field of electronics over the past years has enabled computer equipment manufacturers to provide powerful, fully-featured computers that are compact and portable. Such computers have proven to be extremely popular and a wide variety of such computers are known and commercially available. A portable computer apparatus typically has at least a subset of the following components: a housing for containing the computer circuitry and other electronic components; a power source (e.g., a battery or a cable for connecting the apparatus to a source of power); a user input apparatus (e.g., an alphanumeric keyboard or a mouse); and an output means (e.g., a text and/or graphic display and/or a printer) for communicating information to the user. In addition, portable computer equipment will frequently be equipped with data storage devices, such as a floppy disk drive or a hard disk drive.
Conventional programmers have generally been “standalone” devices and portable like that of portable computer apparatus as described above. For example, several available programmers include the Medtronic Model 9710 for which some further detail is described in U.S. Pat. No. 5,168,871 to Grevious, entitled “Method And Apparatus For Processing Quasi-Transient Telemetry Signals In Noisy Environments”; Medtronic Model No. 9760 for which some further detail is described in U.S. Registration No. H1347 to Greeninger et al., entitled “Audio Feedback For Implantable Medical Device Instruments;” and Medtronic Model No. 9790 for which some further detail is described in U.S. Pat. No. 5,372,607

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