Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20030028226 A1
Publication typeApplication
Application numberUS 10/251,509
Publication dateFeb 6, 2003
Filing dateSep 20, 2002
Priority dateJun 19, 1998
Also published asDE19927853A1, DE19927853B4, DE19927853B8, US6477424
Publication number10251509, 251509, US 2003/0028226 A1, US 2003/028226 A1, US 20030028226 A1, US 20030028226A1, US 2003028226 A1, US 2003028226A1, US-A1-20030028226, US-A1-2003028226, US2003/0028226A1, US2003/028226A1, US20030028226 A1, US20030028226A1, US2003028226 A1, US2003028226A1
InventorsDavid Thompson, Steven Goedeke
Original AssigneeMedtronic, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Medical management system integrated programming apparatus for communication with an implantable medical device
US 20030028226 A1
Abstract
An implantable medical device communication system includes an implantable medical device, a medical information management system, and a module interface apparatus for facilitating communication therebetween. The implantable medical device includes transmitter/receiver circuitry coupled to a device antenna. The medical information management system includes at least a computer processing unit and a display unit. The module interface apparatus includes interface receiver/transmitter circuitry coupled to an interface antenna to communicate with the device transmitter/receiver circuitry via the device antenna. Further, the module interface apparatus includes interface circuitry operable to adapt data (e.g., programming commands) received from the medical information management system for transmittal to the implantable medical device and adapt data received from the implantable medical device (e.g., device data including operational data, physiological parameter data, analyzed data, diagnostic data, etc.) such as to communicate such information to the medical information management system.
Images(8)
Previous page
Next page
Claims(59)
What is claimed is:
1. An implantable medical device communication system, the system comprising:
an implantable medical device, wherein the implantable medical device includes at least one of a device transmitter and device receiver coupled to a device antenna;
a medical information management system, wherein the medical information management system includes at least a computer processing unit and a display unit; and
at least one module interface apparatus, wherein the at least one module interface apparatus includes:
at least one of an interface receiver and an interface transmitter coupled to an interface antenna to communicate with the at least one of the device transmitter and the device receiver via the device antenna, and
interface circuitry operable to at least one of adapt data received from the medical information management system for provision to the interface transmitter to communicate such information to the implantable medical device and adapt data received from the interface receiver to communicate such information to the medical information management system.
2. The system of claim 1, wherein the at least one module interface apparatus includes:
a module housing, wherein the interface circuitry and the at least one of the interface receiver and the interface transmitter are enclosed within the module housing;
a programming head containing the interface antenna; and
a cable electrically connecting the programming head to the at least one module housing.
3. The system of claim 1, wherein the at least one module interface apparatus includes a module housing, wherein the interface circuitry and the at least one of the interface receiver and the interface transmitter are enclosed within the module housing, and further wherein the interface antenna includes one or more antennas external to the module housing.
4. The system of claim 1, wherein the interface circuitry includes processing circuitry to receive and process information from the interface receiver received from the implantable medical device representative of device data for communication of such processed information to the medical information management system.
5. The system of claim 1, wherein the at least one module interface apparatus comprises a plurality of interface modules, wherein each interface module is operable for use in communication of information between an external device corresponding to the interface module and the medical information management system, and further wherein at least one interface module of the plurality of interface modules is operable for use in communication of information between the implantable medical device and the medical information management system.
6. The system of claim 1, wherein the medical information management system includes a battery operable computer processing unit.
7. The system of claim 6, wherein the battery operable computer processing unit is associated with a user interface to allow a user to provide programming commands to the at least one module interface apparatus for communication to the implantable medical device.
8. The system of claim 6, wherein the battery operable computer processing unit receives device data from the at least one module interface apparatus.
9. The system of claim 1, wherein the medical information management system includes a computer network.
10. The system of claim 9, wherein the computer network includes a computer subsystem including the computer processing unit having an associated user interface to allow a user to provide programming commands to the at least one module interface apparatus for communication to the implantable medical device.
11. The system of claim 9, wherein the computer network receives device data from the at least one interface module.
12. The system of claim 1, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
13. A programming system for use in programming implantable medical devices, the system comprising:
an implantable medical device, wherein the implantable medical device includes at least a device receiver coupled to a device antenna; and
a medical information management system, wherein the medical information management system includes a computer network, at least one computer subsystem having a user interface associated with a display operable on the computer network, and a plurality of interface modules, wherein each of the interface modules is operable for use in communication of information between an external device corresponding to the interface module and the at least one computer subsystem, and further wherein at least one interface module of the plurality of interface modules is operable for use in communication of programming commands from the medical information management system to the implantable medical device.
14. The system of claim 13, wherein the at least one interface module includes an interface transmitter coupled to an interface antenna to communicate with the device receiver via the device antenna.
15. The system of claim 14, wherein the at least one interface module further includes interface circuitry operable to adapt data received from the medical information management system for provision to the interface transmitter to communicate programming commands to the implantable medical device.
16. The system of claim 14, wherein the at least one interface module includes a module housing, wherein the interface transmitter is enclosed within the module housing and is operably associated with the interface antenna contained within a programming head, and further wherein a cable electrically connects the programming head to the interface transmitter.
17. The system of claim 14, wherein the at least one interface module includes a module housing, wherein the interface transmitter is enclosed within the module housing and is operably associated with the interface antenna positioned external to the module housing.
18. The system of claim 13, wherein the user interface allows a user to provide the programming commands to the at least one interface module for communication to the implantable medical device.
19. The system of claim 13, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
20. A system for uplink of data from implanted medical devices, the system comprising:
an implantable medical device, wherein the implantable medical device includes at least a device transmitter coupled to a device antenna; and
a medical information management system, wherein the medical information management system includes a computer network, at least one computer subsystem having a user interface associated with a display operable on the computer network, and a plurality of interface modules, wherein each of the interface modules is operable for use in communication of information between an external device corresponding to the interface module and the computer network, and further wherein at least one interface module of the plurality of interface modules is operable for use in communication of device data from the implantable medical device to the medical information management system.
21. The system of claim 20, wherein the at least one interface module includes an interface receiver coupled to an interface antenna to communicate with the device transmitter via the device antenna.
22. The system of claim 21, wherein the at least one interface module further includes interface circuitry operable to adapt device data received from the interface receiver to communicate such device data to the medical information management system.
23. The system of claim 22, wherein the at least one interface module includes a module housing, wherein the interface receiver and interface circuitry is enclosed within the module housing and is operably associated with the interface antenna contained within a programming head, and further wherein a cable electrically connects the programming head to the interface receiver.
24. The system of claim 22, wherein the at least one interface module includes a module, wherein the interface receiver and interface circuitry is enclosed within the module housing and is operably associated with the interface antenna positioned external to the module housing.
25. The system of claim 22, wherein the interface circuitry includes processing circuitry to receive and process device data from the interface receiver received from the device transmitter of the implantable medical device.
26. The system of claim 25, wherein the device data is one of diagnostic data, physiological parameter data, operational data, and analyzed data.
27. The system of claim 22, wherein the interface circuitry includes at least a driver operable for communication of information to the medical information management system.
28. The system of claim 20, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
29. An interface apparatus for use in facilitating communication between an implantable medical device and a medical information management system, wherein the medical information management system includes at least a computer processing unit and a display unit, wherein the implantable medical device includes at least one of a device transmitter and device receiver coupled to a device antenna, the interface apparatus comprising:
an interface module, wherein the interface module includes:
at least one of an interface receiver and an interface transmitter coupled to an interface antenna operable to communicate with the at least one of the device transmitter and the device receiver via the device antenna, and
interface circuitry operable to at least one of adapt data received from the medical information management system for provision to the interface transmitter to communicate such information to the implantable medical device and adapt data received from the interface receiver to communicate such information to the medical information management system.
30. The interface apparatus of claim 29, wherein the interface module includes:
a module housing, wherein the interface circuitry and the at least one of the interface receiver and the interface transmitter are enclosed within the module housing;
a programming head containing the interface antenna; and
a cable electrically connecting the programming head to the interface module.
31. The interface apparatus of claim 29, wherein the medical information management system includes a plurality of plug-in slots for receiving a plurality of interface modules corresponding to a plurality of external devices, wherein a module housing enclosing the interface circuitry and the at least one of the interface receiver and the interface transmitter is configured for insertion in one of the plurality of plug-in slots of the medical information management system.
32. The interface apparatus of claim 29, wherein the interface module includes a module housing, wherein the interface circuitry and the at least one of the interface receiver and the interface transmitter are enclosed within the module housing, and further wherein the interface antenna is external to the module housing.
33. The interface apparatus of claim 29, wherein the interface circuitry includes processing circuitry to receive and process information from the interface receiver received from the implantable medical device representative of device data for communication of such processed information to the medical information management system.
34. The interface apparatus of claim 29, wherein the medical information management system includes a user interface to allow a user to provide programming commands to the interface module for communication to the implantable medical device.
35. The interface apparatus of claim 29, wherein the medical information management network receives device data from the interface module.
36. A programming system for use in programming implantable medical devices, the system comprising:
an implantable medical device, wherein the implantable medical device includes at least a device receiver coupled to a device antenna; and
a battery operable computer system having a user interface associated with a display unit and a plurality of interface modules connected thereto, wherein each of the interface modules is operable for use in communication of information between an external device corresponding to the interface module and the computer system, and further wherein at least one interface module of the plurality of interface modules is operable for use in providing programming information received from the computer system to the implantable medical device.
37. The system of claim 36, wherein the at least one interface module includes an interface transmitter coupled to an interface antenna to communicate with the device receiver via the device antenna.
38. The system of claim 36, wherein the at least one interface module further includes interface circuitry operable to adapt data received from the medical information management system for provision to the interface transmitter to communicate such information to the implantable medical device.
39. The system of claim 36, wherein the at least one interface module includes a module housing, wherein the interface transmitter is enclosed within the module housing and is operably associated with the interface antenna contained within a programming head, and further wherein a cable electrically connects the programming head to the at least one interface module.
40. The system of claim 36, wherein the at least one interface module includes a module housing, wherein the interface transmitter is enclosed within the module housing and is operably associated with the interface antenna positioned external to the module housing.
41. The system of claim 36, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
42. A system for uplink of information from implanted medical devices, the system comprising:
an implantable medical device, wherein the implantable medical device includes at least a device transmitter coupled to a device antenna; and
a battery operable computer system and a plurality of interface modules connected thereto, wherein each of the interface modules is operable for use in communication of information between an external device corresponding to the interface module and the computer system, and further wherein at least one interface module of the plurality of interface modules is operable for use in providing device data received from the implantable medical device to the computer system.
43. The system of claim 42, wherein the at least one interface module includes an interface receiver coupled to an interface antenna to communicate with the device transmitter via the device antenna.
44. The system of claim 43, wherein the at least one interface module further includes interface circuitry operable to adapt device data received from the interface receiver to communicate such device data to the battery operable computer system.
45. The system of claim 44, wherein the at least one interface module includes a module housing, wherein the interface circuitry and the interface receiver are enclosed within the module housing and is operably associated with the interface antenna contained within a programming head, and further wherein a cable electrically connects the programming head to the at least one interface module.
46. The system of claim 44, wherein the at least one interface module includes a module housing, wherein the interface receiver is enclosed within the module housing and is operably associated with the interface antenna positioned external to the module housing.
47. The system of claim 42, wherein the device data is one of diagnostic data, physiological parameter data, operational data, and analyzed data.
48. The system of claim 42, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
49. An implantable medical device programming method, the method comprising steps of:
providing an implantable medical device, wherein the implantable medical device includes at least a device receiver coupled to a device antenna;
providing a medical information management system, wherein the medical information management system includes at least a processing unit and a display unit;
providing an interface module, wherein the at least one interface module includes at least an interface transmitter operable with the device receiver;
receiving data representative of programming commands at the interface module from the computer system;
adapting the data representative of programming commands for transmission to the implantable medical device; and
transmitting the adapted data by the interface transmitter via the interface antenna to the device antenna of the implantable medical device.
50. The method of claim 49, wherein the medical information management system comprises a plurality of interface modules, wherein each interface module is operable for use in interfacing to an external device.
51. The method of claim 49, wherein the medical information management system includes a battery operable processing unit.
52. The method of claim 49, wherein the medical information management system includes a computer network, wherein the at least one processing unit is connected thereon.
53. The method of claim 49, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
54. An implantable medical device uplink communication method, the method comprising steps of:
providing an implantable medical device, wherein the implantable medical device includes at least a device transmitter coupled to a device antenna;
providing a medical information management system, wherein the medical management system includes at least a processing unit and a display unit;
providing an interface module, wherein the at least one interface module includes at least an interface receiver operable with the device transmitter; and
receiving device data at the interface module from the device transmitter of the implantable medical device via the interface antenna;
adapting the device data for provision to the medical
information management system; and
providing the adapted device data to the medical information management system.
55. The method of claim 54, further comprising a step of processing data received by the interface receiver from the implantable medical device.
56. The method of claim 54, wherein the medical information management system includes a battery operable processing unit.
57. The method of claim 54, wherein the medical information management system includes a computer network, wherein the is processing unit is connected thereon.
58. The method of claim 54, wherein the device data from the implantable medical device is one of physiological parameter data, diagnostic data, operational data, and analyzed data.
59. The method of claim 54, wherein the implantable medical device includes an implanted medical device selected from one of a pacemaker, a defibrillator, a pacemaker/cardioverter/defibrillator, a brain stimulator, a cardioverter/defibrillator, a neurostimulator, a muscle stimulator, a gastric stimulator, an implantable monitor, a hemodynamic monitor, and a drug pump.
Description
    CROSS-REFERENCE TO RELATION APPLICATIONS
  • [0001]
    This application claims the benefit of U.S. Provisional Application No. 60/089,868, filed Jun. 19, 1998.
  • FIELD OF THE INVENTION
  • [0002]
    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
  • [0003]
    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.
  • [0004]
    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.
  • [0005]
    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.
  • [0006]
    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.”
  • [0007]
    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.”
  • [0008]
    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.
  • [0009]
    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.
  • [0010]
    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.
  • [0011]
    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.
  • [0012]
    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 to Stone et al., entitled, “Method And Apparatus For Monitoring Pacemaker Intervals.” Generally, such standalone devices are portable, as described above, completely self-contained devices that require the use of paper, cable connections, diskettes, or an infrared (IR) link to generate archival data.
  • [0013]
    Such conventional standalone programming apparatus have some shortcomings. For example, such standalone devices are generally time consuming to design and develop. Further, from a computer hardware perspective, such programming apparatus must continually be updated and upgraded to keep up with current hardware technology improvements, e.g., new processors, electrical circuitry, etc. As such, these programmers are generally relatively expensive.
  • [0014]
    In addition, conventional programming apparatus generally require that an extensive amount of diagnostic data be generated which is reviewed and integrated into a patient's file. However, such data is generally required to be manually entered by either or all of the following methods including handwritten entry, keyboard entry, and printing of forms and then assembly of them into the patient's file. This may lead to errors during the transfer of such data and limit the amount of data saved because of time constraints.
  • [0015]
    Table 1 below lists U.S. Patents relating to various components of implantable medical device communication systems.
    TABLE 1
    U.S. Pat. No. Inventor(s) Issue Date
    5,527,348 Winkler et al. Jun. 18, 1996
    5,372,607 Stone et al. Dec. 13, 1994
    H1347 Greeninger et al. Aug. 2, 1994
    5,683,432 Goedeke et at. Nov. 4, 1997
    5,168,871 Grevious Dec. 8, 1998
  • [0016]
    All references listed in Table 1, and elsewhere herein, are incorporated by reference in their respective entireties. As those of ordinary skill in the art will appreciate readily upon reading the Summary of the Invention, Detailed Description of the Embodiments, and claims set forth below, at least some of the apparatus and methods disclosed in the references of Table 1 and elsewhere herein may be modified advantageously by using the teachings of the present invention. However, the listing of any such references in Table 1, or elsewhere herein, is by no means an indication that such references are prior art to the present invention.
  • SUMMARY OF THE INVENTION
  • [0017]
    The present invention has certain objects. That is, various embodiments of the present invention provide solutions to one or more problems existing in the prior art with respect to programming apparatus. One of such problems involves the use of standalone programmers. For example, with the use of standalone programmers, it is generally required to continually update hardware with the development of new technology. Further, design and development of standalone programmers is relatively expensive. Yet further, data generated by standalone programmers must generally be reviewed and integrated into a patient's file. Due to the standalone nature of the programmers, it is sometimes necessary to manually enter such data into a patient's file. Generally, such manual entering leads to undesirable errors in the patient's file and limitation as to the amount of data saved.
  • [0018]
    In comparison to known programming apparatus, various embodiments of the present invention may provide one or more of the following advantages. For example, expensive hardware upgrading is reduced. Further, data generated by an implantable medical device may be integrated more readily and more comprehensively into a patient's file. As such, errors due to manual entry may be eliminated. Further, for example, the use of an already existing infrastructure into which a programming apparatus according to the present invention is integrated, allows the programming apparatus to “piggyback” on the natural progression of the infrastructure, e.g., hospital/clinic capital upgrades. Such a piggyback arrangement would reduce the need to continually upgrade operating systems, print options, database management, and connectivity requirements provided by the existing infrastructure. Further, it would reduce capital investment required by entities (e.g., hospitals, clinics, etc.) due to the already existing infrastructure to facilitate communication with the implantable medical device.
  • [0019]
    Some embodiments of the present invention include one or more of the following features: a module interface apparatus for facilitating communication between an implantable medical device and a medical information management system (e.g., a currently existing infrastructure of a medical facility computer communication network); a module interface apparatus including at least one of an interface receiver and an interface transmitter coupled to an interface antenna to communicate with at least one of a device transmitter and a device receiver of an implantable medical device; a module interface apparatus that includes interface circuitry operable to adapt data received from the medical information management system for provision to the interface transmitter to communicate such information to the implantable medical device; a module interface apparatus that includes interface circuitry to adapt data received from the interface receiver to communicate such information to a medical information management system; an interface module that includes a module housing which encloses at least one of an interface receiver and an interface transmitter wherein a programming head contains an interface antenna and a cable electrically connects the programming head to the interface module; an interface module that includes a module housing, wherein at least one of the interface receiver and interface transmitter are enclosed within the module housing and further wherein the interface antenna is external to the module housing; an interface module that includes processing circuitry to receive and process information signals from an interface receiver received from a implantable medical device; a plurality of interface modules, wherein each interface module is operable for use in communication of information between an external device corresponding to the interface module and a medical information management system; a medical information management system that includes a battery operable processing unit; a medical information management system that includes a computer network; programming commands provided to the interface module from a medical information management system; diagnostic and/or physiological parameter data provided from an interface module to a medical information management system; a programming method wherein data representing programming commands is received at an interface module, the data is adapted for transmission to the implantable medical device, and the adapted data is transmitted by an interface antenna to the implantable medical device; an implantable medical device uplink communication method wherein data is received from an interface module from a device transmitter of an implantable medical device by an interface antenna, the data received is adapted for provision to a medical information management system, and the adapted data is provided to the medical information management system.
  • [0020]
    The above summary of the present invention is not intended to describe each embodiment of every implementation of the present invention. Advantages, together with a more complete understanding of the invention, will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0021]
    [0021]FIG. 1 is a diagram illustrating an implantable medical device communication system according to the present invention including an implantable medical device in a body for communication with a medical information management system.
  • [0022]
    [0022]FIG. 2 is a general block diagram of circuitry of one embodiment of the implantable medical device of FIG. 1 including receiver and transmitter circuitry for use in communication according to the present invention.
  • [0023]
    [0023]FIG. 3 is a general block diagram of the communication system of FIG. 1 according to the present invention using a module interface apparatus for communication between the implantable medical device and the medical information management system.
  • [0024]
    [0024]FIG. 4 is one embodiment of the module interface apparatus of FIG. 3 in communication with an implantable medical device according to the present invention.
  • [0025]
    [0025]FIG. 5 is an alternate embodiment of the module interface apparatus of FIG. 3 in communication with an implantable medical device according to the present invention.
  • [0026]
    [0026]FIG. 6 is one illustrative embodiment of a medical information management system for use in the system of FIG. 3 including a computer network according to the present invention.
  • [0027]
    [0027]FIG. 7 is an alternate medical information management system for use in the system of FIG. 3 wherein the medical information management system includes a portable battery operable computer processing system.
  • DETAILED DESCRIPTION OF THE EMBODIMENTS
  • [0028]
    [0028]FIG. 1 is a simplified schematic view of an implantable medical device communication system 9 according to the present invention. The implantable medical device communication system 9 includes an implantable medical device 12 for communication through a link 8 (including a module interface apparatus 15 shown in FIG. 3) with a medical information management system 13. The present invention leverages a medical information management system's infrastructure (e.g., computer subsystems, control stations, networks, print options, database management, operating systems, etc.) which are generally upgraded on a continuous basis with regard to hardware thereof. For example, such medical information management systems, as described further below, may be conventional monitoring systems such as a computer networked system in a hospital facility. Generally, for example, such a medical information management system 13 can be configured for acceptance of one or more interface modules, e.g., plug-in modules, for interfacing external devices to the medical information management system 13. The present invention uses the infrastructure of the medical information management system 13 to implement a programming apparatus for communication with an implantable medical device 12. For example, such communication may include both downlink communications, e.g., communication of programming commands to the implantable medical device 12, and uplink communications, e.g., communication of diagnostic/physiological parameter data, to the medical information management system 13.
  • [0029]
    As shown in FIG. 1, the implantable medical device 12 is implanted in a body 10 near a human heart 16. Implanted medical device 12 is electrically connected to the heart by leads 14. In the case where the implanted medical device 12 is a pacemaker, the leads 14 are pacing and sensing leads connected to the heart 16 from the implanted medical device 12. Such leads sense electrical signals attendant to the depolarization and repolarization of the heart 16 and provide pacing pulses for causing depolarization of cardiac tissue in the vicinity of the distal ends thereof. Implantable medical device 12 may be any implantable cardiac pacemaker such as those disclosed in U.S. Pat. No. 5,158,078 to Bennett et al.; U.S. Pat. No. 5,312,453 to Shelton et al.; or U.S. Pat. No. 5,144,949 to Olson.
  • [0030]
    Implantable medical device 12 may also be a pacemaker-cardioverter-defibrillator (PCD) corresponding to any of the various commercially-available implantable PCDs. For example, the present invention may be practiced in conjunction with PCDs such as those described in U.S. Pat. No. 5,545,186 to Olson et al.; U.S. Pat. No. 5,354,316 to Keimel; U.S. Pat. No. 5,314,430 to Bardy; U.S. Pat. No. 5,131,388 to Pless; or U.S. Pat. No. 4,821,723 to Baker, et al.
  • [0031]
    Alternatively, implantable medical device 12 may be an implantable nerve stimulator or muscle stimulator such as that disclosed in U.S. Pat. No. 5,199,428 to Obel et al.; U.S. Pat. No. 5,207,218 to Carpentier et al.; U.S. Pat. No. 5,330,507 to Schwartz; or an implantable monitoring device such as that disclosed in U.S. Pat. No. 5,331,966 issued to Bennett et al.
  • [0032]
    Further, for example, the implanted medical device 12 may be a defibrillator, a cardioverter-defibrillator, a brain stimulator, a gastric stimulator, a drug pump, a hemodynamic monitoring device, or any other implantable device that would benefit from a communication system according to the present invention as described herein. Therefore, the present invention is believed to find wide application for use with any form of implantable medical device. As such, a description herein making reference to any particular medical device is not to be taken as a limitation of the type of medical device which can benefit from and which can be employed with a communication system as described herein.
  • [0033]
    In general, the implantable medical device 12 may include a hermetically sealed enclosure that may include various elements such as an electrochemical cell (e.g., a lithium battery), circuitry that controls device operations and records rhythmic EGM episodes, telemetry transceiver antenna and circuitry that communicates with the module interface apparatus as further described herein. Generally, the implantable medical device 12 is implemented with a microprocessor-based architecture. However, electronic features and operations of the implantable medical device 12 may be implemented in discrete logic or as a microcomputer-based system, as would be readily apparent to one skilled in the art.
  • [0034]
    [0034]FIG. 2 shows a block diagram illustrating components of a pacemaker 11 in accordance with one embodiment of the present invention where pacemaker 11 has RF transmitter and receiver circuitry 54 for communication via the pacemaker antenna 56 with the module interface apparatus 15 according to the present invention as further described herein. In the illustrative embodiment shown in FIG. 2, the pacemaker 11 is preferably programmable according to the present invention. Device antenna 56 is connected to input/output circuit 32 to permit uplink/downlink communication through RF device transmitter and receiver circuitry 54.
  • [0035]
    Pacemaker 11 illustratively shown in FIG. 2 is electrically coupled to the patient's heart 16 by lead 14. Lead 14 is coupled to a node 52 in the circuitry of pacemaker 11 through input capacitor 50. In the presently disclosed embodiment, an activity sensor 62 provides a sensor output to an activity circuit 36 of input/output circuit 32.
  • [0036]
    Input/output circuit 32 also contains circuits for interfacing to heart 16, antenna 56, and contains circuits 44 for application of stimulating pulses to heart 16 to control its rate under control of software-implemented algorithms in microcomputer unit 18.
  • [0037]
    Microcomputer unit 18 preferably comprises on-board circuit 19 that includes microprocessor 20, system clock 22, and on-board random access memory (RAM) 24 and read-only memory (ROM) 26. In this illustrative embodiment, off-board circuit 28 comprises a RAM/ROM unit. On-board circuit 19 and off-board circuit 28 are each coupled by a communication bus 30 to digital controller/timer circuit 34.
  • [0038]
    The electrical components shown in FIG. 2 are powered by an appropriate implantable battery power source 64 in accordance with common practice in the art. For the sake of clarity, the coupling of battery power to the various components of pacemaker 11 is not shown in the figures.
  • [0039]
    VREF and bias circuit 60 generates a stable voltage reference and bias currents for circuits of input/output circuit 32. Analog to digital converter (ADC) and multiplexer unit 58 digitizes analog signals and voltages to provide “real-time” telemetry intracardiac and/or sensor signals and battery end-of-life (EOL) replacement function.
  • [0040]
    Operating commands for controlling the timing of pacemaker 11 are coupled by bus 30 to digital controller/timer circuit 34, where digital timers and counters establish the overall escape interval of the pacemaker as well as various refractory, blanking, and other timing windows for controlling the operation of the peripheral components disposed within input/output circuit 32. Digital controller/timer circuit 34 is preferably coupled to sense circuitry 38, including sense amplifier 42, peak sense and threshold measurement unit 41, and comparator/threshold detector 40. Sense amplifier 42 amplifies sensed electrocardiac signals and provides an amplified signal to peak sense and threshold measurement circuitry 41. Circuitry 41 in turn provides an indication of peak sensed voltages and measured sense amplifier threshold voltages on path 43 to digital controller/timer circuit 34. An amplified sense amplifier signal is also provided to comparator/threshold detector 40. Sense amplifier 42 may, for example, correspond to that disclosed in U.S. Pat. No. 4,379,459 to Stein.
  • [0041]
    Circuit 34 is further preferably coupled to electrogram (EGM) amplifier 46 for receiving amplified process signals sensed by an electrode disposed on lead 14. The electrogram signal provided by EGM amplifier 46 is employed when the implanted device is being interrogated by an external programming apparatus to transmit by uplink telemetry a representation of an analog electrogram of the patient's electrical heart activity. Such functionality is, for example, shown in U.S. Pat. No. 4,556,063 to Thompson et al. Output pulse generator 44 provides pulsing stimuli to the patient's heart 16 through coupling capacitor 48 in response to a pacing trigger signal provided by digital controller/timer circuit 34. Output amplifier 44, for example, may correspond generally to the output amplifier disclosed in U.S. Pat. No. 4,476,868 to Thompson.
  • [0042]
    [0042]FIG. 3 is a block diagram of the implantable medical device communication system 9 according to the present invention. The implantable medical device communication system 9 includes the implantable medical device 12, a medical information management system 13, and a module interface apparatus 15. The implantable medical device 12 may include any implantable medical device such as those previously described herein. According to the present invention, the implantable medical device 12 includes transmitter and/or receiver circuitry 121 for use in communication of information between the implantable medical device 12 and the medical information management system 13. It will be recognized by one skilled in the art that the implantable medical device 12 may include a receiver, a transmitter, or both depending upon whether uplink, downlink, or a combination of uplink and downlink channels for the communication of information between the implantable medical device 12 and the medical information management system 13 are to be established.
  • [0043]
    Generally, implantable medical device 12 may receive programming commands from an external device positioned external to the skin of the patient. Such programmer command instructions are referred to herein as downlink transmissions, i.e., transmissions to the implantable medical device 12. For example, received programming commands may include program instructions or steps for directing the operation of the implantable medical device 12. Further, for example, the received command instructions may also include data such as program limits and timing data. Similarly, the implantable medical device 12 may transmit data external to the skin of the patient. Such transmissions are referred to herein as uplink transmissions, i.e., transmissions from the implantable medical device 12. In other words, the implantable medical device transmits data as well as receives data. Generally, implanted medical device 12 includes receiver and transmitter circuitry 121 which cooperate with other circuitry of the implanted medical device 12 to receive information via a device antenna 130 and to transmit data via the device antenna 130.
  • [0044]
    Medical information management system 13 refers generally to a system operable for receiving information from one or more external devices with the capability of processing such data. Preferably, according to the present invention, the medical information management system 13 is operable with a plug-in module interface architecture. Preferably, the plug-in module interface architecture includes hardware for receiving a plurality of interface modules such that medical products which provide digital and/or analog outputs can be integrated, i.e., interfaced, to the medical information management system 13. Generally, the medical information management system 13 at a minimum includes a computer processing system for providing processing capabilities relative to information received from the implantable medical device 12. Further, preferably, the medical information management system 13 includes a user interface (e.g., keyboard, mouse, touch screen, and associated software interface such as a Windows-based interface) associated with a display unit for use in providing programming for the implantable medical device 12. One skilled in the art will recognize that any number of different peripherals may be components of the medical information management system 13. Preferably, the medical information management system 13 includes at least a processor, a communication network, storage media, a printer/plotter, and a display.
  • [0045]
    [0045]FIGS. 6 and 7 show two embodiments of illustrative medical information management systems 13. FIG. 6 shows a networked medical information management system 270 and FIG. 7 shows a portable battery operable medical information management system 290.
  • [0046]
    The networked medical information management system 270 as shown in FIG. 6 includes one or more computer processing subsystems (e.g., component monitoring system 274) connected to a computer network represented generally as controlled network 272. Generally, such a system 270 is utilized in larger medical facilities. Further, other gateways to the controlled network 272 are provided for various functionality of the networked medical information management system 270. For example, digital telemetry subsystem 288 may be used to provide telemetry to the network 272; a component control manager subsystem 286 may provide for control of various components of the network 272; and various other subsystems 284-288 may provide for various other functions connected to the network, such as alarm systems, hospital patient archival records, laboratory information databases, remote access terminals, etc. One skilled in the art will recognize that various configurations and components of the networked system 270 are possible and that the illustrative FIG. 6 is but one of an unlimited number of configurations possible for such a system 270.
  • [0047]
    Preferably, the networked medical information management system 270 includes at least one component monitoring system 274 (e.g., a computer processing subsystem) wherein the system interacts with a plurality of module interfaces 276. Each of the module interfaces 276 is operable for use in communication of information between an external device 277 corresponding to a module interface and the networked medical information management system 270. For example, the external devices 277 may include devices such as a ventilator, a gas analyzer, a temperature sensor, or any other device external to the body that provides an analog and/or digital output which can be interfaced to the networked medical information management system 270 through the plurality of module interfaces 276.
  • [0048]
    As described above, such a networked medical information management system 270 may include any number of different components, and a listing of the peripherals or components attached to the network 272 are not limited by any of those listed herein. For example, the networked medical information management system 270 may include various computer subsystems, various types of networks, remote modem connections, distributed hospital/clinic connections, database systems, various portable devices, battery back-ups, generators, etc.
  • [0049]
    Various types of already existing infrastructures for networked medical information management systems 270 are available. For example, a networked medical information management system 270 or components thereof are described in U.S. Pat. No. 5,520,191 to Karlsson et al., entitled “Myocardial lschemia And Infarction Analysis And Monitoring Method And Apparatus”; U.S. Pat. No. 5,687,734 to Dempsey et al., entitled “Flexible Patient Monitoring System Featuring A Multiport Transmitter”; U.S. Pat. No. 5,417,222 to Dempsey et al., entitled “Patient Monitoring System”; and U.S. Pat. No. 5,579,775 to Dempsey et al., entitled, “Dynamic control Of A Patient Monitoring System.” Preferably, according to the present invention, the networked medical information management system 270 includes the utilization of the Hewlett Packard Component Monitoring System (CMS) available under the trade designation Viridia CMS which with its associated display unit (e.g., flat screen or CRT color monitor) can be networked to a computer network. Further, preferably, the plurality of interface modules 276 for interfacing various external devices 277 are provided through the use of a plug-in interface available from Hewlett Packard under the trade designation of HP VueLink Interface. Detailed information with regard to the Hewlett Packard CMS and Hewlett Packard VueLink Interface is available from Hewlett Packard Company, Palo Alto, Calif.
  • [0050]
    Generally, the Hewlett Packard CMS is an open architecture system which allows for use of specific functions to be integrated into a Hewlett Packard network and database system. For example, it is possible to provide software on the network for controlling external devices or for receiving information from external devices via the plug-in module open architecture. Such software according to the present invention would provide for the programming of the implantable medical device 12 and/or monitoring of the patient or device implanted therein. The Hewlett Packard CMS is a Windows NT-based system. As the above Hewlett Packard products are commercially available, further details with regard to the system shall not be provided herein for simplicity purposes.
  • [0051]
    [0051]FIG. 7 shows the portable battery operable medical information management system 290 for use according to the present invention. The portable medical information management system 290 includes a display unit 291 and processing unit 292 which may be powered by a power source 296 that is either battery operated or has a connection to an AC power source, e.g., power cord connection. Further, the battery operable system 290 is operable with one or more interface modules 294 for interfacing various external devices 295, such as those described above, to the processing unit 292. Such a portable or smaller system, for example, may generally be used in a satellite office or in transport of a patient, or, further, for example, in a smaller medical facility.
  • [0052]
    Preferably, according to the present invention, the portable, battery operable medical information management system 290 is a system available from Hewlett Packard under the trade designation HP-M1275A Component Transport System (CTS). Generally, the Hewlett Packard CTS is a system 290 that is a flexible and transportable patient monitoring system based on a variety of components that enable customization to a hospital's requirements. For example, the Hewlett Packard system includes a transport mainframe that contains the display unit and processing capabilities. The system utilizes the same type of interface modules as the HP CMS, which is described in general above with regard to the networked medical information management system 270.
  • [0053]
    Both the HP CMS and CTS systems have similar operator controls and waveform display. A computer subsystem is responsible for parameter processing, display control, and interfacing. The same types of interface modules are receivable in plug-in slots of the component transport system, i.e., the HP VueLink Interface plug-in receiving unit is usable for both the HP CMS and CTS. Some patient-related settings may even be transferred between the CMS and the CTS via an interface module, and vital signs, may, for example, be transferred through such transfer modules.
  • [0054]
    Generally, the interface modules 294, are contained in a separable rack, but the rack is designed to dock with the monitor mainframe which eliminates extra cable requirements. This same type of HP VueLink slot rack can be used for the Hewlett Packard CMS and the CTS.
  • [0055]
    As described above, one skilled in the art will recognize that the medical information management system 13 according to the present invention is preferably a system including the ability to implement software for providing program commands for communication to an implantable medical device and for receiving data and displaying data from the implantable medical device 12, e.g., diagnostic data, physiological parameter data, histograms, counters, trend plots, etc., and preferably processing such data. It will be recognized that in the case of the networked medical information management system 270, monitoring or control of programming may be performed from any node on the network. Further, preferably, the medical information management system 13 is configured for receiving a plurality of interface modules for interfacing to corresponding external devices, e.g., ventilators, gas analyzers, etc. For example, with regard to the Hewlett Packard CMS and the Hewlett Packard CTS, such a configuration is provided with use of the Hewlett Packard VueLink Interface.
  • [0056]
    Preferably, such a configuration includes a plug-in module rack. However, one skilled in the art will recognize that data may be transmitted over a variety of mediums. Therefore, a plug-in rack may not be necessary as in the case of information provided to the medical information management system 13 via a modem connection. The present invention leverages the infrastructure of a medical information management system 13, preferably, a commercially available system whose hardware is continually upgraded. Such leverage is attained by providing a module interface apparatus 15, e.g., a plug-in module that is compatible with the Hewlett Packard VueLink Interface, to interface the implantable medical device 12 to the medical information management system 13. Through the use of the module interface apparatus 15, communication of programming commands from the medical information management system 13 to the implantable medical device 12 can be performed. Further, the module interface apparatus 15 provides for communication of device data from the implantable medical device 12 to the medical information management system 13.
  • [0057]
    This configuration for the implantable medical device communication system 9 reduces the need for a standalone programming apparatus as previously described in the Background of the Invention section herein. In such a configuration of an implantable medical device communication system 9, the module interface apparatus 15 provides the link 8 between the implantable medical device 12 and the medical information management system 13 and piggybacks on the natural progression of such a medical information management system 13. For example, as the medical information management system 13 is upgraded, such upgrades are passed through to the programming communication system according to the present invention without the necessary incorporation of technological advances in a conventional standalone programming apparatus. As such, this reduces the need to continually upgrade the operating system, print options, database management systems, connectivity requirements, etc. with respect to the integrated programming apparatus according to the present invention. This is unlike a standalone programmer apparatus which would require such continual upgrades. Further, data is available for input directly into a patient's record in the medical information management system 13 without the need for transfer of such data from a standalone programmer which conventionally in some circumstances needed to be done manually with possibility of error.
  • [0058]
    Generally, the module interface apparatus 15 shown in FIG. 3 includes at least transmitter/receiver circuitry 123 and an interface antenna 131 for transmitting and receiving electromagnetic energy. The module interface apparatus 15 includes receiver circuitry that is compatible with the transmitter of the implantable medical device 12 and operable for receiving and extracting, e.g., demodulating, data from the transmitted signal from the implantable medical device 12. Further, the module interface apparatus 15 includes transmitter circuitry that is compatible with the receiver of the implantable medical device 112 and operable for generating a modulated signal of which the receiver of the implantable medical device 112 is capable of receiving and extracting e.g., demodulating, information therefrom.
  • [0059]
    Generally, the implantable medical device communication system 9 may be used for communication of information to the implantable medical device 12 or from the implantable medical device 12. In the case of providing programming commands to the implantable medical device 12, data representative of programming commands is received at the module interface apparatus 15. The medical information management system 13 includes the necessary operating system, user interface, database management, and any software necessary and compatible with the programming requirements of the implantable medical device 12 to provide the appropriate programming commands to the module interface apparatus 15. The module interface apparatus 15 includes interface circuitry 128 to adapt the programming data for transmission by the transmitter/receiver circuitry 123 to the implantable medical device 12. The data representative of the programming commands is adapted by the interface circuitry 128 and provided to the interface transmitter of the receiver/transmitter circuitry 123.
  • [0060]
    The adaptation of the data representative of the programming commands by the interface circuitry 128 may include any number of operations, such as for example, amplification, processing, conditioning, parallel to serial conversion, data buffering, error detection and correction, data encryption/encoding, data compression, telemetry link management and channel management, operational status (e.g., module status lights, warnings indicators, etc.) and any other operation necessary as determined by the type of telemetry used between the transmitter of the module interface apparatus 15 and the receiver of the implantable medical device 12. The adapted data representative of the programming commands is then transmitted via the interface antenna 131 of the module interface apparatus 15 to the implantable medical device 12 where it is received at the device antenna 130 and detected by device receiver/transmitter circuitry 121. Likewise, device data may be provided by the implantable medical device 12 to the medical information management system 13 through the module interface apparatus 15. Device data may include any type of data provided by an implantable medical device including real-time and stored data, such as diagnostic data (e.g., data for patient diagnosis or implanted device function diagnosis), physiological parameter data (e.g., oxygen sensed levels, activity sensor data, ECG waveforms and data, etc.), operational data (e.g., lead impedance data, battery voltage data, etc., and analyzed data (e.g., variability plot data, trend data, etc.). Data is transmitted by the device transmitter of transmitter/receiver circuitry 121 via the device antenna 130. The electromagnetic energy is received at the interface antenna 131 of the module interface apparatus 15 and a received signal is provided to the receiver of the receiver/transmitter circuitry 123 for detection and extraction of transmitted data from the signal. Upon extraction of the data by the interface receiver of the transmitter/receiver circuitry 123, the interface circuitry 128 of the module interface apparatus 15 adapts the data for provision to the medical information management system 13. For example, such adaptation may include amplification, conditioning, processing, serial to parallel conversion of the stream of data, data management/formatting, data compression, data encryption, report generation, data buffering, error detection/correction, or any other any other operation necessary as determined by the type of telemetry used between the receiver of the module interface apparatus 15 and the transmitter of the implantable medical device 12. The adapted data representative of the device data received via the interface antenna 131 is then provided to the medical information management system 13.
  • [0061]
    Further, more extensive processing may be performed in the module interface apparatus 15 upon operation of optional processing circuitry 133. For example, the processing circuitry 133 may act upon the device data received from the implantable medical device 12 to provide a sampled amount of data, to provide data representative of a physiological parameter based upon multiple sensor outputs signals, to provide an alarm status upon operation of detection circuitry for detecting a warning event, and to provide operational status indication (e.g., status lights to indicate proper telemetry function, programming confirmation, etc.) The adapted data is then provided to the medical information management system 13.
  • [0062]
    The communication of data from the module interface apparatus 15 to the medical information management system 13 may be accomplished in a number of manners. For example, in conjunction with the use of a plug-in module such as used in the HP VueLink Interface for the HP CMS and CTS equipment, the transfer of data between the module interface apparatus 15 and the medical information management system 13 may be accomplished by a direct electrical line, e.g., Local Area Network (LAN) or Wide Area Network (WAN). However, various other methods of transport may be used as well, such as RF transmission, or any other wireless technologies, modem technologies, infrared technologies, optical technologies, etc.
  • [0063]
    In its simplest form for the transmission of programming information to the implantable medical device 12, the module interface apparatus 15 includes an interface antenna 131 for transmitting electromagnetic waves to the device antenna of the implantable medical device and an interface transmitter that is compatible with the device receiver of the implantable medical device 12. In other words, for example, the modulation and demodulation techniques and operating frequencies of the corresponding device receiver and module interface transmitter are compatible. Likewise, for transmission from the implantable medical device 12 to the module interface apparatus 15, the device transmitter of receiver/transmitter circuitry 121 is compatible with the interface receiver of receiver/transmitter circuitry 123 of the module interface apparatus 15. In other words, for example, the modulation and demodulation techniques and operating frequencies of the corresponding device transmitter and the interface module receiver are compatible.
  • [0064]
    Two illustrative embodiments of the module interface apparatus 15 are illustrated in FIGS. 4 and 5. However, various systems for performing telemetry between the implantable medical device 12 and module interface apparatus 15 may be used and are known. For example, several of such systems are described in U.S. Pat. No. 5,127,404 issued to Wyborney et al.; U.S. Pat. No. 4,556,063 issued to Thompson et al.; and U.S. Pat. No. 5,342,408 issued to De Coriolis et al.
  • [0065]
    As shown in FIG. 4, module interface apparatus 120 includes an interface module 125 including a module housing which contains transceiver circuitry 122 and any other circuitry such as previously described herein. The module interface apparatus 120 further includes an antenna positioned within a programmer head 124 connected to the transceiver circuitry 122 via a stretchable cable 126 and is powered by source 140. Further, data 148 is communicated to the medical information management network 13. Wireless communication and/or any other electrical connection may be possible between the programmer head and the interface module 121. The programmer head 124 containing the antenna may then be positioned at the implant site relative to device antenna 130 and the implantable medical device 12 which contains the transceiver circuitry 121. Such an interface may be used in conjunction with telemetry according to U.S. Pat. No. 5,527,348; a low frequency (175 kHz), near field (34 inches), and low data rate (4-50 k baud) telemetry system.
  • [0066]
    [0066]FIG. 5 provides an alternate module interface apparatus 150. The module interface apparatus 150 includes interface module 151 which has a module housing to contain the transceiver circuitry 152 and any other circuitry of the apparatus 150 such as described previously herein. Power is applied by power source 154 and data 156 is communicated to the medical information management system 13. The transceiver circuitry 152 is connected to one or more antennas 158, represented by antenna elements 160, 162. Communication may then be performed via the device antenna 130 and the implantable medical device 12 which contains the transceiver circuitry 121. In this case, a programmer head is unnecessary and telemetry is generally accomplished using a system such as described in U.S. Pat. No. 5,683,432; a high frequency (400 MHz), far field (to 30 feet), and high data rate (to 100 k baud) telemetry system.
  • [0067]
    All patents and references cited herein are incorporated in their entirety as if each were incorporated separately. This invention has been described with reference to illustrative embodiments and is not meant to be construed in a limiting sense. As described previously, one skilled in the art will recognize that various other telemetry techniques for providing communication between an implantable medical device and module interface apparatus may be used in addition to those previously described herein. Further, various modifications of the illustrative embodiments, as well as additional embodiments of the invention, will be apparent to a person skilled in the art upon reference to this description.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US4168871 *Mar 20, 1978Sep 25, 1979Firma Erwin Dierkes KleinmobelfabrikShoe rack
US4379459 *Apr 9, 1981Apr 12, 1983Medtronic, Inc.Cardiac pacemaker sense amplifier
US4476868 *Sep 8, 1980Oct 16, 1984Medtronic, Inc.Body stimulator output circuit
US4556063 *Dec 7, 1984Dec 3, 1985Medtronic, Inc.Telemetry system for a medical device
US4821723 *Feb 27, 1987Apr 18, 1989Intermedics Inc.Biphasic waveforms for defibrillation
US5127404 *Sep 25, 1991Jul 7, 1992Medtronic, Inc.Telemetry format for implanted medical device
US5131388 *Mar 14, 1991Jul 21, 1992Ventritex, Inc.Implantable cardiac defibrillator with improved capacitors
US5144949 *Mar 15, 1991Sep 8, 1992Medtronic, Inc.Dual chamber rate responsive pacemaker with automatic mode switching
US5158078 *Aug 14, 1990Oct 27, 1992Medtronic, Inc.Rate responsive pacemaker and methods for optimizing its operation
US5199428 *Mar 22, 1991Apr 6, 1993Medtronic, Inc.Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload
US5207218 *Feb 27, 1991May 4, 1993Medtronic, Inc.Implantable pulse generator
US5312453 *May 11, 1992May 17, 1994Medtronic, Inc.Rate responsive cardiac pacemaker and method for work-modulating pacing rate deceleration
US5314430 *Jun 24, 1993May 24, 1994Medtronic, Inc.Atrial defibrillator employing transvenous and subcutaneous electrodes and method of use
US5330507 *Apr 24, 1992Jul 19, 1994Medtronic, Inc.Implantable electrical vagal stimulation for prevention or interruption of life threatening arrhythmias
US5331966 *Dec 16, 1993Jul 26, 1994Medtronic, Inc.Subcutaneous multi-electrode sensing system, method and pacer
US5342408 *Jan 7, 1993Aug 30, 1994Incontrol, Inc.Telemetry system for an implantable cardiac device
US5345362 *Apr 29, 1993Sep 6, 1994Medtronic, Inc.Portable computer apparatus with articulating display panel
US5354316 *Jan 29, 1993Oct 11, 1994Medtronic, Inc.Method and apparatus for detection and treatment of tachycardia and fibrillation
US5372607 *Jun 23, 1993Dec 13, 1994Medtronic, Inc.Method and apparatus for monitoring pacemaker intervals
US5417222 *Jan 21, 1994May 23, 1995Hewlett-Packard CompanyPatient monitoring system
US5520191 *Oct 7, 1994May 28, 1996Ortivus Medical AbMyocardial ischemia and infarction analysis and monitoring method and apparatus
US5527348 *Feb 3, 1995Jun 18, 1996Medtronic, Inc.Magnetically permeable E-shield and method of connection thereto
US5545186 *Mar 30, 1995Aug 13, 1996Medtronic, Inc.Prioritized rule based method and apparatus for diagnosis and treatment of arrhythmias
US5579775 *Oct 20, 1994Dec 3, 1996Hewlett-Packard CompanyDynamic control of a patient monitoring system
US5626630 *Oct 13, 1994May 6, 1997Ael Industries, Inc.Medical telemetry system using an implanted passive transponder
US5683432 *Jan 11, 1996Nov 4, 1997Medtronic, Inc.Adaptive, performance-optimizing communication system for communicating with an implanted medical device
US5687734 *Oct 20, 1994Nov 18, 1997Hewlett-Packard CompanyFlexible patient monitoring system featuring a multiport transmitter
US5752976 *Jun 23, 1995May 19, 1998Medtronic, Inc.World wide patient location and data telemetry system for implantable medical devices
US6150951 *Oct 23, 1998Nov 21, 2000Hewlett-PackardMedical telemetry system with wireless and physical communication channels
USH1347 *Nov 9, 1992Aug 2, 1994Medtronic Inc.Audio feedback for implantable medical device instruments
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US7047076Mar 24, 2004May 16, 2006Cardiac Pacemakers, Inc.Inverted-F antenna configuration for an implantable medical device
US7751894Jul 6, 2010Cardiac Pacemakers, Inc.Systems and methods for indicating aberrant behavior detected by an implanted medical device
US7794499Jun 8, 2004Sep 14, 2010Theken Disc, L.L.C.Prosthetic intervertebral spinal disc with integral microprocessor
US7869867Jan 11, 2011Cyberonics, Inc.Implantable neurostimulator with refractory stimulation
US7869885Apr 28, 2006Jan 11, 2011Cyberonics, IncThreshold optimization for tissue stimulation therapy
US7974701Apr 27, 2007Jul 5, 2011Cyberonics, Inc.Dosing limitation for an implantable medical device
US7978064Jul 12, 2011Proteus Biomedical, Inc.Communication system with partial power source
US8036748Nov 13, 2009Oct 11, 2011Proteus Biomedical, Inc.Ingestible therapy activator system and method
US8054140Oct 17, 2007Nov 8, 2011Proteus Biomedical, Inc.Low voltage oscillator for medical devices
US8055334Dec 10, 2009Nov 8, 2011Proteus Biomedical, Inc.Evaluation of gastrointestinal function using portable electroviscerography systems and methods of using the same
US8055476 *Nov 5, 2008Nov 8, 2011Siemens AktiengesellschaftSystem and method to minimize downtimes of medical apparatuses
US8114021Dec 15, 2009Feb 14, 2012Proteus Biomedical, Inc.Body-associated receiver and method
US8115618May 23, 2008Feb 14, 2012Proteus Biomedical, Inc.RFID antenna for in-body device
US8150508Mar 29, 2007Apr 3, 2012Catholic Healthcare WestVagus nerve stimulation method
US8219188Jul 10, 2012Catholic Healthcare WestSynchronization of vagus nerve stimulation with the cardiac cycle of a patient
US8258962Mar 5, 2009Sep 4, 2012Proteus Biomedical, Inc.Multi-mode communication ingestible event markers and systems, and methods of using the same
US8280505Oct 2, 2012Catholic Healthcare WestVagus nerve stimulation method
US8306627Nov 6, 2012Cyberonics, Inc.Dosing limitation for an implantable medical device
US8540632May 23, 2008Sep 24, 2013Proteus Digital Health, Inc.Low profile antenna for in body device
US8540633Aug 13, 2009Sep 24, 2013Proteus Digital Health, Inc.Identifier circuits for generating unique identifiable indicators and techniques for producing same
US8540664Mar 24, 2010Sep 24, 2013Proteus Digital Health, Inc.Probablistic pharmacokinetic and pharmacodynamic modeling
US8542123Aug 1, 2012Sep 24, 2013Proteus Digital Health, Inc.Multi-mode communication ingestible event markers and systems, and methods of using the same
US8545402Apr 27, 2010Oct 1, 2013Proteus Digital Health, Inc.Highly reliable ingestible event markers and methods for using the same
US8545436Dec 23, 2011Oct 1, 2013Proteus Digital Health, Inc.Body-associated receiver and method
US8547248Sep 1, 2006Oct 1, 2013Proteus Digital Health, Inc.Implantable zero-wire communications system
US8558563Aug 23, 2010Oct 15, 2013Proteus Digital Health, Inc.Apparatus and method for measuring biochemical parameters
US8565867Jan 25, 2008Oct 22, 2013Cyberonics, Inc.Changeable electrode polarity stimulation by an implantable medical device
US8583227Sep 23, 2011Nov 12, 2013Proteus Digital Health, Inc.Evaluation of gastrointestinal function using portable electroviscerography systems and methods of using the same
US8597186Jan 5, 2010Dec 3, 2013Proteus Digital Health, Inc.Pharmaceutical dosages delivery system
US8615309Mar 29, 2007Dec 24, 2013Catholic Healthcare WestMicroburst electrical stimulation of cranial nerves for the treatment of medical conditions
US8660666Mar 10, 2009Feb 25, 2014Catholic Healthcare WestMicroburst electrical stimulation of cranial nerves for the treatment of medical conditions
US8674825Mar 13, 2009Mar 18, 2014Proteus Digital Health, Inc.Pharma-informatics system
US8718193Nov 19, 2007May 6, 2014Proteus Digital Health, Inc.Active signal processing personal health signal receivers
US8721540Nov 18, 2010May 13, 2014Proteus Digital Health, Inc.Ingestible circuitry
US8730031Jul 11, 2011May 20, 2014Proteus Digital Health, Inc.Communication system using an implantable device
US8738126Mar 10, 2009May 27, 2014Catholic Healthcare WestSynchronization of vagus nerve stimulation with the cardiac cycle of a patient
US8784308Dec 2, 2010Jul 22, 2014Proteus Digital Health, Inc.Integrated ingestible event marker system with pharmaceutical product
US8802183Jul 11, 2011Aug 12, 2014Proteus Digital Health, Inc.Communication system with enhanced partial power source and method of manufacturing same
US8805506 *May 17, 2012Aug 12, 2014Boston Scientific Neuromodulation CorporationSystem and method for programming neurostimulation devices using cached plug-in software drivers
US8810409May 6, 2013Aug 19, 2014Proteus Digital Health, Inc.Multi-mode communication ingestible event markers and systems, and methods of using the same
US8816847Jun 3, 2011Aug 26, 2014Proteus Digital Health, Inc.Communication system with partial power source
US8836513Jul 11, 2011Sep 16, 2014Proteus Digital Health, Inc.Communication system incorporated in an ingestible product
US8847766Apr 28, 2006Sep 30, 2014Proteus Digital Health, Inc.Pharma-informatics system
US8858432Feb 1, 2008Oct 14, 2014Proteus Digital Health, Inc.Ingestible event marker systems
US8868453Nov 4, 2010Oct 21, 2014Proteus Digital Health, Inc.System for supply chain management
US8912908Jul 11, 2011Dec 16, 2014Proteus Digital Health, Inc.Communication system with remote activation
US8932221Mar 7, 2008Jan 13, 2015Proteus Digital Health, Inc.In-body device having a multi-directional transmitter
US8945005Oct 25, 2007Feb 3, 2015Proteus Digital Health, Inc.Controlled activation ingestible identifier
US8956287May 2, 2007Feb 17, 2015Proteus Digital Health, Inc.Patient customized therapeutic regimens
US8956288Feb 14, 2008Feb 17, 2015Proteus Digital Health, Inc.In-body power source having high surface area electrode
US8961412Sep 25, 2008Feb 24, 2015Proteus Digital Health, Inc.In-body device with virtual dipole signal amplification
US9014779Jan 28, 2011Apr 21, 2015Proteus Digital Health, Inc.Data gathering system
US9060708Jul 25, 2014Jun 23, 2015Proteus Digital Health, Inc.Multi-mode communication ingestible event markers and systems, and methods of using the same
US9083589Mar 6, 2014Jul 14, 2015Proteus Digital Health, Inc.Active signal processing personal health signal receivers
US9107806Nov 18, 2011Aug 18, 2015Proteus Digital Health, Inc.Ingestible device with pharmaceutical product
US9108041Nov 25, 2013Aug 18, 2015Dignity HealthMicroburst electrical stimulation of cranial nerves for the treatment of medical conditions
US9119554Nov 18, 2010Sep 1, 2015Proteus Digital Health, Inc.Pharma-informatics system
US9119918May 8, 2013Sep 1, 2015Proteus Digital Health, Inc.Probablistic pharmacokinetic and pharmacodynamic modeling
US9119969Jul 1, 2014Sep 1, 2015Boston Scientific Neuromodulation CorporationSystem and method for programming neurostimulation devices using cached plug-in software drivers
US9149423May 10, 2010Oct 6, 2015Proteus Digital Health, Inc.Ingestible event markers comprising an ingestible component
US9149577Apr 30, 2013Oct 6, 2015Proteus Digital Health, Inc.Body-associated receiver and method
US9161707Sep 12, 2014Oct 20, 2015Proteus Digital Health, Inc.Communication system incorporated in an ingestible product
US9198608Nov 23, 2011Dec 1, 2015Proteus Digital Health, Inc.Communication system incorporated in a container
US9216294 *Mar 5, 2014Dec 22, 2015Medtronic Urinary Solutions, Inc.Systems and methods for clinician control of stimulation systems
US9235683Nov 9, 2011Jan 12, 2016Proteus Digital Health, Inc.Apparatus, system, and method for managing adherence to a regimen
US9248298Aug 7, 2007Feb 2, 2016Medtronic, Inc.Medical device programmer with selective disablement of display during telemetry
US9248299Apr 14, 2010Feb 2, 2016Medtronic, Inc.Medical device programmer
US9258035Apr 29, 2015Feb 9, 2016Proteus Digital Health, Inc.Multi-mode communication ingestible event markers and systems, and methods of using the same
US9268909Oct 15, 2013Feb 23, 2016Proteus Digital Health, Inc.Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device
US9270025Mar 7, 2008Feb 23, 2016Proteus Digital Health, Inc.In-body device having deployable antenna
US9270503Sep 19, 2014Feb 23, 2016Proteus Digital Health, Inc.Methods, devices and systems for receiving and decoding a signal in the presence of noise using slices and warping
US9271897Jul 22, 2013Mar 1, 2016Proteus Digital Health, Inc.Techniques for manufacturing ingestible event markers comprising an ingestible component
US9289599Apr 3, 2012Mar 22, 2016Dignity HealthVagus nerve stimulation method
US9314633Aug 31, 2012Apr 19, 2016Cyberonics, Inc.Contingent cardio-protection for epilepsy patients
US9320455Jan 31, 2013Apr 26, 2016Proteus Digital Health, Inc.Highly reliable ingestible event markers and methods for using the same
US9345879Mar 7, 2014May 24, 2016Endostim, Inc.Device and implantation system for electrical stimulation of biological systems
US20050273170 *Jun 8, 2004Dec 8, 2005Navarro Richard RProsthetic intervertebral spinal disc with integral microprocessor
US20060276857 *Aug 15, 2006Dec 7, 2006Medtronic, Inc.Medical device programmer with infrared communication
US20070233192 *Mar 29, 2007Oct 4, 2007Catholic Healthcare West (D/B/A St. Joseph's Hospital And Medical Center)Vagus nerve stimulation method
US20070233193 *Mar 29, 2007Oct 4, 2007Catholic Healthcare West (D/B/A St. Joseph's Hospital And Medical Center)Microburst electrical stimulation of cranial nerves for the treatment of medical conditions
US20070233194 *Mar 29, 2007Oct 4, 2007Catholic Healthcare West (D/B/A St. Joseph's Hospital And Medical Center)Synchronization of vagus nerve stimulation with the cardiac cycle of a patient
US20070255351 *Apr 28, 2006Nov 1, 2007Cyberonics, Inc.Threshold optimization for tissue stimulation therapy
US20070288068 *Aug 7, 2007Dec 13, 2007Medtronic, Inc.Medical device programmer with selective disablement of display during telemetry
US20080269839 *Apr 27, 2007Oct 30, 2008Armstrong Randolph KDosing Limitation for an Implantable Medical Device
US20080306360 *May 23, 2008Dec 11, 2008Robertson Timothy LLow profile antenna for in body device
US20090076338 *May 2, 2007Mar 19, 2009Zdeblick Mark JPatient customized therapeutic regimens
US20090082645 *Sep 25, 2008Mar 26, 2009Proteus Biomedical, Inc.In-body device with virtual dipole signal amplification
US20090119067 *Nov 5, 2008May 7, 2009Wolfgang StempferSystem and method to minimize downtimes of medical apparatuses
US20090135886 *Nov 26, 2008May 28, 2009Proteus Biomedical, Inc.Transbody communication systems employing communication channels
US20090177252 *Mar 10, 2009Jul 9, 2009Catholic Healthcare West (D/B/A St. Joseph's Hospital And Medical Center)Synchronization of vagus nerve stimulation with the cardiac cycle of a patient
US20090227204 *Mar 13, 2009Sep 10, 2009Timothy RobertsonPharma-Informatics System
US20100022836 *Mar 7, 2008Jan 28, 2010Olivier ColliouIn-body device having a multi-directional transmitter
US20100081894 *Sep 21, 2009Apr 1, 2010Proteus Biomedical, Inc.Communication system with partial power source
US20100185055 *Feb 1, 2008Jul 22, 2010Timothy RobertsonIngestible event marker systems
US20100262032 *Oct 14, 2010Freeberg Scott MSystems and Methods for Indicating Aberrant Behavior Detected by an Implanted Medical Device
US20100316158 *Nov 19, 2007Dec 16, 2010Lawrence ArneActive signal processing personal health signal receivers
US20110054265 *Apr 27, 2010Mar 3, 2011Hooman HafeziHighly reliable ingestible event markers and methods for using the same
US20110065983 *Nov 18, 2010Mar 17, 2011Hooman HafeziIngestible Circuitry
US20110196454 *Nov 13, 2009Aug 11, 2011Proteus Biomedical, Inc.Sensing system, device, and method for therapy modulation
US20110212782 *Oct 14, 2009Sep 1, 2011Andrew ThompsonMethod and System for Incorporating Physiologic Data in a Gaming Environment
US20110224758 *Sep 15, 2011Cyberonics, Inc.Dosing Limitation For An Implantable Medical Device
US20120296397 *Nov 22, 2012Boston Scientific Neuromodulation CorporationSystem and method for programming neurostimulation devices using cached plug-in software drivers
US20140185107 *Nov 6, 2013Jul 3, 2014Shenyang Neusoft Medical Systems Co., Ltd.Method and device for indicating scanning condition and scanning apparatus and scanning system related thereto
US20140188192 *Mar 5, 2014Jul 3, 2014Medtronic Urinary Solutions, Inc.Systems and methods for clinician control of stimulation systems
WO2007058826A2Nov 6, 2006May 24, 2007Edwards Lifesciences CorporationWireless communication system for pressure monitoring
WO2014144727A1 *Mar 14, 2014Sep 18, 2014Proteus Digital Health, Inc.State characterization based on multi-variate data fusion techniques
Classifications
U.S. Classification607/60
International ClassificationG06F19/00, A61N1/372
Cooperative ClassificationA61N1/37282, G06F19/3418, A61N1/37235, G06F19/3412, A61N1/37223, A61N1/37217
European ClassificationG06F19/34A1, G06F19/34C, A61N1/372D4, A61N1/372D2, A61N1/372D2E