U.S. patent application number 10/251509 was filed with the patent office on 2003-02-06 for medical management system integrated programming apparatus for communication with an implantable medical device.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Goedeke, Steven D., Thompson, David L..
Application Number | 20030028226 10/251509 |
Document ID | / |
Family ID | 26781021 |
Filed Date | 2003-02-06 |
United States Patent
Application |
20030028226 |
Kind Code |
A1 |
Thompson, David L. ; et
al. |
February 6, 2003 |
Medical management system integrated programming apparatus for
communication with an implantable medical device
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.
Inventors: |
Thompson, David L.;
(Fridley, MN) ; Goedeke, Steven D.; (Forest Lake,
MN) |
Correspondence
Address: |
MEDTRONIC, INC.
710 MEDTRONIC PARKWAY NE
MS-LC340
MINNEAPOLIS
MN
55432-5604
US
|
Assignee: |
Medtronic, Inc.
|
Family ID: |
26781021 |
Appl. No.: |
10/251509 |
Filed: |
September 20, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10251509 |
Sep 20, 2002 |
|
|
|
09322560 |
May 28, 1999 |
|
|
|
6477424 |
|
|
|
|
60089868 |
Jun 19, 1998 |
|
|
|
Current U.S.
Class: |
607/60 |
Current CPC
Class: |
A61N 1/37282 20130101;
A61N 1/37235 20130101; A61N 1/37223 20130101; G16H 40/67 20180101;
G16H 40/40 20180101; A61N 1/37217 20130101 |
Class at
Publication: |
607/60 |
International
Class: |
A61N 001/18 |
Claims
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.
1 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] 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] 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] 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] 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] 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] 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] 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] 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] 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] V.sub.REF 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] 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] 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] 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] 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.
* * * * *