CA2378060C - Component architecture for medical device system networks - Google Patents
Component architecture for medical device system networks Download PDFInfo
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- CA2378060C CA2378060C CA002378060A CA2378060A CA2378060C CA 2378060 C CA2378060 C CA 2378060C CA 002378060 A CA002378060 A CA 002378060A CA 2378060 A CA2378060 A CA 2378060A CA 2378060 C CA2378060 C CA 2378060C
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
-
- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
- G16H10/65—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records stored on portable record carriers, e.g. on smartcards, RFID tags or CD
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H15/00—ICT specially adapted for medical reports, e.g. generation or transmission thereof
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/40—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
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- G—PHYSICS
- G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
- G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
- G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
- G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
- Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation
Abstract
A component-based software architecture environment is provided for information networks used for administering one or more implantable medical devices (IMDs) in one or more patients.
Various interface schema which may be used in implementing an IMD network are povided, as well as common interfaces for development of software within the network environment.
The information network, and the software used in and implementing the network, may be upgraded and developed in a distributed and incremental manner, without requiring modification of entire systems or device instructions.
Various interface schema which may be used in implementing an IMD network are povided, as well as common interfaces for development of software within the network environment.
The information network, and the software used in and implementing the network, may be upgraded and developed in a distributed and incremental manner, without requiring modification of entire systems or device instructions.
Description
COMPONENT ARCHITECTURE FOR MEDICAL DEVICE SYSTEM NETWORKS
FIELD OF THE INVENTION
The present invention generally relates to implantable medical devices and instruments. Specifically the invention relates to a system software architecture for medical device systems. More specifically, the invention pertains to implantable medical devices (IMDs) and instruments associated with them in a network environment, in which clinical and physiological data is transferred remotely, and a common software a:--chitecture is implemented to preferably develop and administer the network.
BACKGROUND OF THF, INVENTION
The monitoring and administration of implantable medical devices (IMDs) may be well-suited to computerized and networked administration. The modern IMD is capable of sensing and storing large amounts of physiologic data from the host patient, and is also capable of implementing a treatment regimen based at least =_n part on this data -IMDs themselves naturally contain a powerful processing capacity in their own right. In addition, remote administration of IMDs via networks or other telecorlmunications media is being developed, and various IMD systems enable remote administration, such as those pat:_ent management and chronic systems as illustrated and described in United States Patent Serial No. 6,250,309 entitled "Sys)tem and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location".
Networked and computerized IMD administration systems, based as they are on a distributed computerized environment pose numerous challenc[es in the development of software in the implementation or maintenance of such systems. The consituent processo:--s of an IMD management system, for example, exist in numerous patients at the IMD
level, and in an equally large nurnber of residential and clinical settings, all of which are being modified, replaced, and upgraded at various times according to the needs of the patients and clinicians using the system at any given time. The administration of such a network is complicated further by the fact that the software implementing the network may be developed in a dispersed fashion - various IMDs, periphera=_ devices and monitoring equipment, and clinician and admiriistrative computer environments may be developed in a way that is suitable for the task at hand, but may be without particular regard to other possible uses of the software, or the other network nodes with which the software must: communicate. The resulting overall network may be implemented in an atomized, fragmented manner. In addition, the distributed nature of various IMD administration processes may limit the ability of remote users to effect the IMD--related function that is desired at the appropriate time. For example, a user desiring a physiological report regarding a patient may only be able to view such a report if they have direct access to an IMD programmer that has been programmed with the ability to generate reports.
FIELD OF THE INVENTION
The present invention generally relates to implantable medical devices and instruments. Specifically the invention relates to a system software architecture for medical device systems. More specifically, the invention pertains to implantable medical devices (IMDs) and instruments associated with them in a network environment, in which clinical and physiological data is transferred remotely, and a common software a:--chitecture is implemented to preferably develop and administer the network.
BACKGROUND OF THF, INVENTION
The monitoring and administration of implantable medical devices (IMDs) may be well-suited to computerized and networked administration. The modern IMD is capable of sensing and storing large amounts of physiologic data from the host patient, and is also capable of implementing a treatment regimen based at least =_n part on this data -IMDs themselves naturally contain a powerful processing capacity in their own right. In addition, remote administration of IMDs via networks or other telecorlmunications media is being developed, and various IMD systems enable remote administration, such as those pat:_ent management and chronic systems as illustrated and described in United States Patent Serial No. 6,250,309 entitled "Sys)tem and Method for Transferring Information Relating to an Implantable Medical Device to a Remote Location".
Networked and computerized IMD administration systems, based as they are on a distributed computerized environment pose numerous challenc[es in the development of software in the implementation or maintenance of such systems. The consituent processo:--s of an IMD management system, for example, exist in numerous patients at the IMD
level, and in an equally large nurnber of residential and clinical settings, all of which are being modified, replaced, and upgraded at various times according to the needs of the patients and clinicians using the system at any given time. The administration of such a network is complicated further by the fact that the software implementing the network may be developed in a dispersed fashion - various IMDs, periphera=_ devices and monitoring equipment, and clinician and admiriistrative computer environments may be developed in a way that is suitable for the task at hand, but may be without particular regard to other possible uses of the software, or the other network nodes with which the software must: communicate. The resulting overall network may be implemented in an atomized, fragmented manner. In addition, the distributed nature of various IMD administration processes may limit the ability of remote users to effect the IMD--related function that is desired at the appropriate time. For example, a user desiring a physiological report regarding a patient may only be able to view such a report if they have direct access to an IMD programmer that has been programmed with the ability to generate reports.
Component-based: soflware technology provides means for defming and nsing softwa.aree components. Component technology, as implemented in evolving standards such as using CORBA, DCOM and Enterprise Java Beans (E]lB), provide the means for defining and :sofiwarc components. The techniques of soflwallce component teclmology provide superior ways of developing and admiaistering software.
Component technology is related to the developing object teahnology, w9tich uses class-based soiiwara architectum io :enable distrnlbuted and rausable programming. Under object tcchnology, rager #han a monolithic program, or even varions soilwwc modules, software objects an=e provided with an interface which may be used by otber programmners who may not be familiar with the internai workiiqp of the software objects.
Tnstead, they are provided with an interFace which may take the form of ceitain defined dstatypes, or of "public" fimctions, which they can access by providing lcnown arguments or quantitics, and they may expect a cert* type of data according to the dr5nition of the inteeface.
Tbe interfaco may be implemented by means of datatypes meeting objed or structtne definitions both in the interface and the accessing program; the i~nteifacx may also be accessed by means of "public" fimctions in the object of thc }nterfaee.
"public in this, the progmmiag sense, means a fimction accessible..to a later developer, but does not necessary imply that the interface tie5nitions or fuactions m-ill be published outside of the entity creating the inttuface code. The soflwam objectr may be eacapsulatedJ Le., i#
maybe specified by the original author thad they may not be modified by a programmar or developer who later uses the object. Just as the techniques of objed oriented analysis, design and pmgranming provide superior ways of dealing with the logical struuKiam of software, so the techniques ofcompcment technology provide superior wa)+s of dealing with the physical structln+e of soRware. A software coaponent willl ideally provide a well-defin4 "guaranteed" int+Grface which may be relied on by programmers; an implemeotadon separated from the interface of wlrich a programmer usin$ the com;onent may be ignoramt;
a physical implementation of the software that is separately :releasable and versiomabk;
aad wt'll be free from cyclic depeadencies. This means that a compone,nt may not use, i.e.
depend <m another component, if that second component already depends dircctl3ror indhvctly on the first component. These ideal characteristics of components provide for softwwe tbat may have its fimctionality physically distn'buted among client.: and servers across networlCS. The soAware may, in addition, have its functionality distributed across programming languages - providing interoperability between components implemented in different languages (C/C++, Java, Smalltalk, etc.).
An attendant benefit of this component architecture is that the software programming and maintenance task may be distributed - software may be divided into smaller pieces that can be built separately, but according to stable, common definitions assuring interoperability if the definitions are adhered to. This, in turn, provides more easily understood and maintained code. The cost of modifying the code is more easily estimated and controlled, should software changes be required. This in turn is due to the shortened incremental build times of components, because a change to the implementation of one component doesn't require rebuilding other components. The code is more easily reused by other projects, and standardized "off the shelf" development tools based on established components may be developed by various parties.
SUMMARY OF THE INVENTION
In one aspect of the invention, there is provided a hardware module comprising: a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing the hardware module to execute standardized software interfaces to medical device interface instruments and IMDs (Implantable Medical Devices) each medical device interface instrument and IMD using one of a plurality of programming platforms or languages; and means for communicating with a data communication network, the network comprising at least one medical device interface instrument and a plurality of IMDs, and with a medical device external to the hardware module, said hardware module being deployable to a plurality of medical device interface instruments.
In a second aspect of the invention, there is provided a computer readable medium for use in an IMD
(Implanted Medical Device) administration network in which one or more interface instruments are in communication with 5 a plurality of medical devices applied to one or more patients, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing a computer to:
instruct or operate an IMD interface instrument; utilize at least one software interface definition of a defined body of software interface definitions to communicate with at least one of the IMD interface instrument and the computerized IMD
administrative network.
In a third aspect of the invention, there is provided a system comprising: a computerized network of processing equipment with at least two nodes remote from each other, the network comprising a plurality of medical device interface instruments, each medical device interface instrument using one of a plurality of programming platforms or languages; a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to the medical device interface instruments in the computerized network; and means for executing the computer readable code via the standardized software interfaces from remote processing equipment.
In a fourth aspect of the invention, there is provided a component-based IMD administration and control instrument, comprising: a master processing instrument having network communications capabilities for communicating with an IMD administration and control network; an electronics module having telemetry and processing capabilities installed within said master processing instrument; and a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to a plurality of medical device interface instruments in the IMD administration and control network, each medical device interface instrument interface using one of a plurality of programming platforms or languages.
In a fifth aspect of the invention, there is provided an IMD monitoring and administration network environment implementing reusable and extendable computer readable code, comprising: a plurality of IMDs, each using one of a plurality of programming platforms or languages, at least one of the IMDs being in communication with at least one IMD interface device; said at least one IMD interface devices having a computer readable medium in message-passing relation with at least one network interface, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to medical device interface instruments in the network environment; said at least one network interface being in message-passing relation with at least one user node.
In a sixth aspect, there is provided a method of implementing a compartmentalized, IMD monitoring and administration network, comprising the steps of: establishing a data communications link between at least one IMD and one computer via an interface device; programming at least one computer readable medium with a first component based computer executable code to execute on the interface device, the computer executable code being capable of causing the interface device to perform message-passing communications over data communications media; programming at least another 6a computer readable medium with a second component based computer executable code to execute on a linked computer, said second computer executable code, being capable of causing the linked computer to operate in a message-passing relationship with the interface device.
The present invention provides a component-based software architecture specifically adapted for enhancing the communication and operability of instruments and IMDs over a communications network. The invention may be implemented in a manner that is compatible with remote patient management systems that interact with remote data and expert data 6b centers. Tbrough use of the component-based software architecture environment, the information network and the software used in and implementing the network, may be upgraded and developed in.a distributed and incremental manner, without requiring modification of entire systems or device instruction.sets.. Specifically, the invention is compatible with a data communication system that has the capacity to transfer clinical data from the patient to a remote location for evaluation, analysis, data reposition, and, clinical evaluation. The component design of the software that may implement the present invention provides for distributting soflware fanctionality between network nodes without:regard to the programming language or platform of the communicating components. The software fnnctionality of the various components may, in addition to being distributed across nodes and languages, be-distnbuted in time, i.e., the functions may take place at discrete and disparate times. The present invention may also be used with various data mining and network communication systems, including those implemented over a public network such as the Intemet. According to one embodiment of the invention, component software I5 architecture is implemented in..conjunction with a hardware unit which provides fuactionality suited for the software architecture being implemented.
Modern TlvIla administration may be effected in large part through the use of interface instruments, i.e., dedicated IlvID appliances that obtain data and-instruct IIvIDs, and accordingly are capable of communication-with deployed I1VIDs, for example,.tltrough telemetry. Examples of such interface instruments include, for example, IlvID
Prograam.ers, IIvID Extenders, IIVD Interactive Remote Monitors, INID Interface Mediaal 1:3nits, and INM
Pacing System Analyzers. The fimction of these devices, particularly in a networked environment,, are detailed in U.S. Patent Serial No. 6,250,309. According to a preferred embodiment=.of the present invention, code reuse may be implemented between these interface instruments, as well as within an interface instrument but across device applications. In otber words, several software elements may be used in a single interface device, and-be exploited in connection with several different llvIDs or I1VID
ffimctions. In this embodiment, software components may be developed that may have applicability to a number of different devices with which an instrument may interface.
In a further embodiment of the present invention, software developed according to the invention may be optimized'for use on a standardized hardware module which may be incorporated into any interface instrument. This hardware module maybe referred to generally as a Link Electronics Module, or LEM. The LEM may have the capacity to 6c conduct te]emetry communication with a deployed IMI7, commtmicate with other TMD
peripheral appliances sucb as Pacing System Anatyzers, conduct IMM waveform and marker processing, conduct ECG waveform processing, and detect artifa.cts, i.e., the measurable effect of successful IlvID functioning-ffie detection of the device ad,,,inistming tlicrapy, Other functions preferably implemented in the LEM may include the consolidation or synchronization of data to facilitate or enable display, storage, and networl, transuission.
Under this function, the LEM may poll various data sources, consolidate these sources -into a message, e.g., an XM, document, and transmit the data in a-consolidated statA
The LEM
may also effect data compression or encryption, where the data payload is identified or standardized in accordance with def ned component interface featturs. The LEM
may also preferably consolidate or synchronize-real-time data of various types or from varions sources, e.g., ECG and EGM graphical data, togetherwith.applicable annotationsIo these graphical data, in the form of artifact and marker annotations. These data, which in their native foimat may a,rrive at different rates or times, as they are collected by diffe,rent sensors and may be '1 S sampled at different rates; via the LEM.they may be synchronized and/or consolidated, and presented per one or more- component interfaces for transmission to various'client intztines;
' cIient" in this context meaning a requesting process generally, and not neeessariIy a client network node. In addition, the LEM, through its software or firmware, may detect or implement state changes in the interface instrument or IMD, provide real-time or continuous recording of ECG samples and IlVID waveform samples or markers, provide analog output of ECG or waveform samples, markers, or artifacts. This latter function, which may be considered a chart recording function, also preferably implements a report printing function which may be directly transmitted to a suitable display, plotter, or printer.
The LEM may also be implemented to accept analog input from IMDs for processing by the LEM
hardware unit or the interface instruinent overall. Another common function required for interface instruments that may be implemented and standardized within the LEM is the upgrade or loading of executable or object code as firmware or software for execution on the interface instrument's master processor, which does not reside within the LEM.
Similarly, the LEM
may provide upgrades to the flash memory or similar instruction RAM of the IMD
itself.
Peripheral software resident on interface instruments and other IMD peripheral devices may be implemented according to the invention to consist of two major parts: The first part is the peripheral subsystem running on the peripheral hardware or LEM. In order to incorporate the LEM into various interface instruments, a peripheral interface is developed for various interface instruments. The peripheral interface is implemented to run on that interface instrument's master processor, so that the functions of the LEM may be flawlessly incorporated into the functionality of the interface instrument as a whole. In this way, standardized LEM software components may be iinplemented and upgraded centrally using the coinponeiit interfaces already accessed by the interface instniment processor.
Various common fi.tnctions of interface instruments may be "componentized"
according to the present invention. In a preferred embodiment, for example, a Report Generator coinponent is developed that can execute within the Programmer or on other networked devices existing within a larger IMD administration network. This requires the device application, resident on the IMD itself, to export the required content in the agreed-upon format for the desired report. The user may then preferably be presented with the option to save the export image. hi this way, the user may generate reports at a later time in a remote location if desired. This present invention also may execute a Waveform Monitor within a larger IMD administration networlc. In this way, saved waveform information, as opposed to real-time data, may be accessed via various remote computing and communication devices that have access to the IMD administration and support network. For exainple, a user at a remote PC may execute a wavefonn monitor device and be connected to an active programmer interfacing with the Peripheral Component. In this case the user would be able to view a live real time waveform from an implanted device. Based on the common component architecture of the system, upgrades to the PC or other device user interface or analytic software may be changed and upgraded without regard to the programming of the IMD itself, of the LEM, or of the interface instrument. Likewise, any of these components may theinselves be reprogrammed without impact on the other elements, as long as the component interface definitions are respected. Other functions necessary for the functioning of an IMD administration networlc that may be implemented as component software modules within the LEM include the collection of real-time waveform data, e.g., ECG, EGM, and inarlcer notation indicating when an IMD has administered a treatment or is in some other relevant operational status. In addition, the LEM with component software may process waveform data and perform analysis or the data or display the output of the ECG, for example. While an hnplant Device Application may be changed, this will not have an impact on the LEM or any other networle node, as long as the "public" component definitions are respected by the developers of the Implant Device Application.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic network diagram of an IMD administration network according to an embodiment of the present invention.
Figure 2 is a schematic diagram showing the hardware environment in which an embodiment of the present invention may be implemented.
Figure 3 is an architectural diagram for implementation of a software component system according to an embodiment of the present invention.
Figure 4 is an architectural diagram of an alternative embodiment of a software component system according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a component-based software architecture specifically adapted for enhancing the commi.ulication and interoperability of instruments and IMDs over a communications network, while providing a reusable and scalable software system that may be easily upgraded in a distributed fashion as new devices and fiuictionalities are developed.
The invention is preferably developed in a manner compatible with a communications network that implements a remote patient management systems that interact with remote data and expert data centers. At least some of the nodes of such a network are interface instrtiments, i.e., peripheral devices capable both of wireless commtmications with one or more IMDs in one or more patients, and of commtuiications over a computer network.
According to a preferred embodiment of the present invention, code reuse may be implemented between these interface instnunents, as well as within an instrument but across device applications. In this embodiment, software components may be generated which may have applicability to a number of different devices that an instntment may interface with.
Figure 1 depicts a typical IMD administration network 110 with which the present invention may be used, and as described in the related patent applications discussed above.
IMD 112 is in telemetric communication with IMD networlc interface 114. IlVID
112, representing one or more IMDs in one or more patients, may also or alternatively be in telemetric communication with progranuner 116, interface medical unit 118, or remote monitor 120. Prograinmer 116, interface medical unit 118, and remote monitor 120 are examples of interface instruments as described generally herein. IMD network interface 114 may be replaced by, or may have installed within, a Linlc Electronics Module, or "LEM" unit, discussed below. Programmer 116, interface medical unit 118, or remote monitor 120 may also have within an LEM unit. The IMD network interface device 114, or interface instrument 116, 118, or 120, or the LEM installed within such instrument, is either directly, or via the LEM or IMD network interface device 114, in communication with network 122.
Network 122 may be a public networlc, such as the Internet, if suitable security precautions are implemented such as firewalls 124. Through network 122 or other network connection, instrument 116, 118, or 120, directly or via internal LEM or IMD network interface 114, may communicate with centralized computing and monitoring computing resource 126.
Computing resource 126 may have access to relevant database 128 relevant to administration of IMD 112. This network, and interface instniments 116, 118, and 120, may also be accessed by remote patient, clinician, or other authorized user personal computer 130.
The positioning of a standardized hardware module, which may be termed a Linlc Electronics Module or LEM unit, which may be installed in interface instrument 114, 116, or 118 of Figure 1, is depicted in Figure 2 as a component,of and relation to IMD
networlc 210.
Preferably, software developed according to the invention may be optimized for use on this standardized hardware module 212 which may then be incorporated into any interface instrument (e.g. 116, 118, or 120 of Figure 1), providing component-based software functionality to the device. In a preferred embodiment, the LEM 212 will have the capacity to perform several typical functions common to various peripheral interface instruments regardless of the particular type of IMD 112 administered with the instrument.
For example, the LEM 212 may be configured to conduct telemetry communication with a deployed IMD
112 via transmitter/receiver 214, communicate with other IMD peripheral appliances such as Pacing System Analyzers 216, conduct IMD waveform and marker processing via processor 218, conduct ECG waveform processing, and detect artifacts. Other functions preferably implemented in the LEM may include the synchronization of data to enable display, storage, and network transmission, all effected on processor 218. In addition, the LEM, through its component software or firnlware stored in storage 220, may detect or implement state 5 changes in the interface instrument or IMD 112, provide real-time or continuous recording of ECG samples and IMD waveform samples or markers, and provide analog output of ECG or waveform samples, markers, or artifacts. This latter function, which may be considered a chart-recording fitnction, also preferably implements a report printing function which may be directly transmitted to a suitable display, plotter, or printer via modem or network interface 10 module 222. The LEM may also be implemented to accept analog input from IMDs 112 or other physiological monitoring equipment for processing by the LEM device or the interface instrument 116 overall. Another common function required for interface instruments that may be iinplemented and standardized within the LEM 212 is the upgrade or loading of executable or object code as firmware or software for execution on the interface instrument's master processor 224, which does not reside within the LEM 212. Similarly, the may provide upgrades to the flash memory or similar instruction RAM of the IMD
112 itself.
The primary function of the LEM with respect to the deployed IMD will be the downlinking of information requests, and the uplinking to the IMD administration network of the IMD's responses. The LEM 212 will have a similar information exchange relationship with Pacing System Analyzer 216, either via direct or networked communication, as depicted in Figure 2, or via telemetry. LEM 212 will downlink information requests to the Pacing System Analyzer (PSA) 216, and uplililc the responses of PSA 216, possibly after consolidating or integrating this data into waveform view information including ECG/EGM
graphical information and annotations.
Certain LEM functions may be provided in hardware or firmware, in addition to flash memory, in order to improve the speed or efficiency of the LEM 212. These functions may be implemented in a manner complying with component definitions, so that the resulting LEM 212 may be easily implemented in most or all interface instruments without modification or translation or the device instructions. A software or firmware module implementing an interface with peripheral interface component will be required in order to malce the LEM fiulctions work with the particular interface instrument.
The software architecture afforded by the present invention is depicted in Figure 3. A
component software system for IMD administration networks is shown at 310.
Implant device application 313 is resident within an implanted IMD, and executes on I1VID master processor 224 of Figure 2. Peripheral software components 314, 316 and 318 are resident on interface instruments such as 114, 116, and 118 of Figure 1, and other IMD
peripheral devices. These peripheral software coinponents 314 may consist of at least two major parts;
the first part being the peripheral subsystem running on the interface instrument hardware or LEM module within the interface instrument. In order to incorporate the LEM
into various interface instruments, a peripheral interface 314 may be developed for various interface instruinents. The peripheral interface may run on the master processor of the interface instrument, 224 of Figure 2, or within LEM processor 218 of Figure 2. In this manner, the functions of the LEM may be incorporated into the entire body of functionality of the interface instntment via interface compliant message passing between peripheral interface 314 running on interface instrument processor 224 of Figure 2, and peripheral subsystem running on LEM 212 of Figure 2. Standardized LEM software components may be iinplemented and upgraded centrally using the component interfaces already accessed by the interface instrument processor. LEM 212 may also provide for detection and reporting of relevant IMD state changes, -many of which may be generalized across IMD
types. LEM 212 may also flash or download executable code and configuration settings into storage of the remote interface instrument 116, 118 or 120 of Figure 1.
The component system according to the invention may provide for reusable modules which perform various common functions of interface instruments. A major common function required of most interface instruments is report generation. A Report Generator component 318 may be developed that can execute within the IMD programmer 116 of Figure 1, or other interface instrument 118 or 120, or within a larger I1VID
administration networlc, for example, on a remote machine 130 of Figure 1. In this way, report generation is no longer confined to, nor must report generation be coded to, a particular medical support device. Data, preferably after being synchronized and compiled, may be sent to a Report Generator Component software module that may be resident within an IMD
interface device, or within a network storage or processing device, and which may include, for example, remote personal computer 130 of Figure 1. Generally, those components on the top interface tier of Figure 3, i.e., Peripheral Interface Component 314, Live Waveform Monitor Component 316, and Report Generator Component 318, may be resident or executed on an interface instniment such as programmer 116 of Figure 1, or may be executed on a network device, including PC 130 of Figure 1, of other suitable device within IMD
information networlc 110. The networlced device running, for example, the Live Waveform Monitor Component 316 may view static waveform information that has been stored, or may view a real-time waveform monitor session via an active programmer or other interface device properly interfacing to the Live Waveform Monitor Component 316.
The device application 312 will be resident on the IMD itself. In this embodiment, the device application must export the required content in the agreed-upon format for the desired report to Report Generator component 318. The user may then preferably be presented with the option to save the export image. In this way, the user may generate reports at a later time in a remote location such as personal computer 130 of Figure 1 if desired. A component-based viewer may be provided in order to view the saved export image. This viewer necessarily uses the component frameworlc of the system as a whole, particularly as regards graphic display.
The report generation component accepts iinplant session data or follow-up session data and generates the user selected report. Preferably, user customization will be provided.
This customization may be implement locally, without impacting the operation of Report Generation Component 318. Only such information as the user has requested, and in the format requested, will be displayed to remote machine 130, according to component standardized requests for information, e.g., via message passing or function calls to public methods of the Report Generator Component 318, or via structured communications with Device Coinponent 313, as discussed herein with reference to Figure 4.
This present invention also may execute a Waveform Monitor Component 316 within a larger IMD administration network. In this way, saved waveform information, as opposed to real-time data, may be accessed via various remote computing and communication devices that have access to the IMD administration and support network. For example, a user at a remote PC 130 of Figtue 1 may execute a waveform monitor device via network interface 320, and be connected to an active programmer (e.g. 116 of Figure 1) interfacing with the interface instruinent. The live waveform monitor component 316 of Figure 3 accepts real time or static waveform data and presents an integrated view to the user. The user can control the number of waveforms (combination of surface ECG and implant device EGM ) along with markers and annotation information.
In this instance, the user would be able to view a live real-time waveform from an implanted device. Based on the common component architecture of the system, upgrades to the PC (130 of Figure 1), or other device user interface or analytic software may be changed and upgraded without regard to the programming of the IMD 112 itself, of the LEM 212, or of the interface instrument. Likewise, any of these components may themselves be reprogrammed without impact on the other elements, as long as the component interface definitions are respected.
An alternate software architecture embodiment of the present invention is depicted in Figure 4. Figure 4 depicts a Device component architecture generally at 410.
Device Component 313 operates centrally within IMD (112 in Figure 1) or interface instrument (114, 116, or 118 of Figure 1). This component is encapsulated and protected from direct access by interface components discussed herein. The Device Component 313 may communicate via any number of structured communications schema, such as those suitable for client-server or other message passing, or function calls and returns. Suitable examples include CORBA, a JavaBeans API, DCOM, XSLT, OAP, or XML. This latter schema, XML, or eXtensible Markup Language, is expected to prove particularly suitable for non-analog interfacing of the components of the instant invention. As depicted in Figure 4, Device Component 313 may send inforination and receive instructions from Controller/Viewer 412, which may be used for programming an IMD, or may interface via XML instructions and responses to Episode Viewer component 414, which may provide read-only access to IMD operation and physiologic infoimation to individuals having properly authenticated access to a network having access to Device Component 313. Device Component 313 may also interface with Trend Viewer Component 416, Paraineter Viewer 418, or Report Generator 318, which may operate in a manner similar to Report Viewer Component 318 of Figure 3. Device Coinponent 313 may also interface via XML using a defined instruction and parameter dictionary with Database, e.g. of patient history information, or with Industry Standard Style-Sheets formatting component 420. The various potential interfaces to which Device Component 313 may interface via XML, this standard is depicted generally by virtual central interface 421.
Device Component 313 may also be accessed by properly, authenticated individuals via Home Monitor Component 422 or Peripheral Interface Coinponent 314.
Peripheral Interface Coinponent 314 may operate in a manner similar to that described with reference to Figure 3. These interface communications may also be implemented using a structured, developer-defined, parsible communication schema such as XML. In a preferred embodiment of the present invention, real-time waveform data for a particular IlVID may be accessed by a remote computer (e.g. 130 of Figure 1), via Live Waveform Component 316.
Live Waveform Component 316 may transmit data from Live Waveform Viewer Component 424 via a communication schema suitable for pictorial/image data, in order to transmit analog graphical information regarding the IMD functions and effect, in order to compare programmed treatment with actual treatment as indicated by interventional artifacts. A
suitable scheme for transmission between components of this analog, or as transmitted what may be termed "pseudo-analog" pictorial representations, is Scalable Vector Graphics, or SVG, a mark-up language which is a W3C standardized grammar defined within the XML
language. Such analog representations, when transmitted to Waveform Viewer Component 316, will preferably include useful data including IMD marlcer and artifact indications on the surface ECG/implant device EGM data, as well as other relevant annotation information.
LEM 212 of Figure 2 will also preferably accept analog or pseudo-analog input from other Components which may feed relevant information for processing by LEM 212. The components of Figure 4, when implemented in accordance with the present invention as standardized interface components, may be individually developed, upgraded, replaced, and redesigned while respecting the interface definitions, such as those defined as XML tags, attributes, elements, or entities, collectively under an XML Document Type Definition suitable for transmission of IMD administration information.
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims.
Component technology is related to the developing object teahnology, w9tich uses class-based soiiwara architectum io :enable distrnlbuted and rausable programming. Under object tcchnology, rager #han a monolithic program, or even varions soilwwc modules, software objects an=e provided with an interface which may be used by otber programmners who may not be familiar with the internai workiiqp of the software objects.
Tnstead, they are provided with an interFace which may take the form of ceitain defined dstatypes, or of "public" fimctions, which they can access by providing lcnown arguments or quantitics, and they may expect a cert* type of data according to the dr5nition of the inteeface.
Tbe interfaco may be implemented by means of datatypes meeting objed or structtne definitions both in the interface and the accessing program; the i~nteifacx may also be accessed by means of "public" fimctions in the object of thc }nterfaee.
"public in this, the progmmiag sense, means a fimction accessible..to a later developer, but does not necessary imply that the interface tie5nitions or fuactions m-ill be published outside of the entity creating the inttuface code. The soflwam objectr may be eacapsulatedJ Le., i#
maybe specified by the original author thad they may not be modified by a programmar or developer who later uses the object. Just as the techniques of objed oriented analysis, design and pmgranming provide superior ways of dealing with the logical struuKiam of software, so the techniques ofcompcment technology provide superior wa)+s of dealing with the physical structln+e of soRware. A software coaponent willl ideally provide a well-defin4 "guaranteed" int+Grface which may be relied on by programmers; an implemeotadon separated from the interface of wlrich a programmer usin$ the com;onent may be ignoramt;
a physical implementation of the software that is separately :releasable and versiomabk;
aad wt'll be free from cyclic depeadencies. This means that a compone,nt may not use, i.e.
depend <m another component, if that second component already depends dircctl3ror indhvctly on the first component. These ideal characteristics of components provide for softwwe tbat may have its fimctionality physically distn'buted among client.: and servers across networlCS. The soAware may, in addition, have its functionality distributed across programming languages - providing interoperability between components implemented in different languages (C/C++, Java, Smalltalk, etc.).
An attendant benefit of this component architecture is that the software programming and maintenance task may be distributed - software may be divided into smaller pieces that can be built separately, but according to stable, common definitions assuring interoperability if the definitions are adhered to. This, in turn, provides more easily understood and maintained code. The cost of modifying the code is more easily estimated and controlled, should software changes be required. This in turn is due to the shortened incremental build times of components, because a change to the implementation of one component doesn't require rebuilding other components. The code is more easily reused by other projects, and standardized "off the shelf" development tools based on established components may be developed by various parties.
SUMMARY OF THE INVENTION
In one aspect of the invention, there is provided a hardware module comprising: a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing the hardware module to execute standardized software interfaces to medical device interface instruments and IMDs (Implantable Medical Devices) each medical device interface instrument and IMD using one of a plurality of programming platforms or languages; and means for communicating with a data communication network, the network comprising at least one medical device interface instrument and a plurality of IMDs, and with a medical device external to the hardware module, said hardware module being deployable to a plurality of medical device interface instruments.
In a second aspect of the invention, there is provided a computer readable medium for use in an IMD
(Implanted Medical Device) administration network in which one or more interface instruments are in communication with 5 a plurality of medical devices applied to one or more patients, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing a computer to:
instruct or operate an IMD interface instrument; utilize at least one software interface definition of a defined body of software interface definitions to communicate with at least one of the IMD interface instrument and the computerized IMD
administrative network.
In a third aspect of the invention, there is provided a system comprising: a computerized network of processing equipment with at least two nodes remote from each other, the network comprising a plurality of medical device interface instruments, each medical device interface instrument using one of a plurality of programming platforms or languages; a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to the medical device interface instruments in the computerized network; and means for executing the computer readable code via the standardized software interfaces from remote processing equipment.
In a fourth aspect of the invention, there is provided a component-based IMD administration and control instrument, comprising: a master processing instrument having network communications capabilities for communicating with an IMD administration and control network; an electronics module having telemetry and processing capabilities installed within said master processing instrument; and a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to a plurality of medical device interface instruments in the IMD administration and control network, each medical device interface instrument interface using one of a plurality of programming platforms or languages.
In a fifth aspect of the invention, there is provided an IMD monitoring and administration network environment implementing reusable and extendable computer readable code, comprising: a plurality of IMDs, each using one of a plurality of programming platforms or languages, at least one of the IMDs being in communication with at least one IMD interface device; said at least one IMD interface devices having a computer readable medium in message-passing relation with at least one network interface, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to medical device interface instruments in the network environment; said at least one network interface being in message-passing relation with at least one user node.
In a sixth aspect, there is provided a method of implementing a compartmentalized, IMD monitoring and administration network, comprising the steps of: establishing a data communications link between at least one IMD and one computer via an interface device; programming at least one computer readable medium with a first component based computer executable code to execute on the interface device, the computer executable code being capable of causing the interface device to perform message-passing communications over data communications media; programming at least another 6a computer readable medium with a second component based computer executable code to execute on a linked computer, said second computer executable code, being capable of causing the linked computer to operate in a message-passing relationship with the interface device.
The present invention provides a component-based software architecture specifically adapted for enhancing the communication and operability of instruments and IMDs over a communications network. The invention may be implemented in a manner that is compatible with remote patient management systems that interact with remote data and expert data 6b centers. Tbrough use of the component-based software architecture environment, the information network and the software used in and implementing the network, may be upgraded and developed in.a distributed and incremental manner, without requiring modification of entire systems or device instruction.sets.. Specifically, the invention is compatible with a data communication system that has the capacity to transfer clinical data from the patient to a remote location for evaluation, analysis, data reposition, and, clinical evaluation. The component design of the software that may implement the present invention provides for distributting soflware fanctionality between network nodes without:regard to the programming language or platform of the communicating components. The software fnnctionality of the various components may, in addition to being distributed across nodes and languages, be-distnbuted in time, i.e., the functions may take place at discrete and disparate times. The present invention may also be used with various data mining and network communication systems, including those implemented over a public network such as the Intemet. According to one embodiment of the invention, component software I5 architecture is implemented in..conjunction with a hardware unit which provides fuactionality suited for the software architecture being implemented.
Modern TlvIla administration may be effected in large part through the use of interface instruments, i.e., dedicated IlvID appliances that obtain data and-instruct IIvIDs, and accordingly are capable of communication-with deployed I1VIDs, for example,.tltrough telemetry. Examples of such interface instruments include, for example, IlvID
Prograam.ers, IIvID Extenders, IIVD Interactive Remote Monitors, INID Interface Mediaal 1:3nits, and INM
Pacing System Analyzers. The fimction of these devices, particularly in a networked environment,, are detailed in U.S. Patent Serial No. 6,250,309. According to a preferred embodiment=.of the present invention, code reuse may be implemented between these interface instruments, as well as within an interface instrument but across device applications. In otber words, several software elements may be used in a single interface device, and-be exploited in connection with several different llvIDs or I1VID
ffimctions. In this embodiment, software components may be developed that may have applicability to a number of different devices with which an instrument may interface.
In a further embodiment of the present invention, software developed according to the invention may be optimized'for use on a standardized hardware module which may be incorporated into any interface instrument. This hardware module maybe referred to generally as a Link Electronics Module, or LEM. The LEM may have the capacity to 6c conduct te]emetry communication with a deployed IMI7, commtmicate with other TMD
peripheral appliances sucb as Pacing System Anatyzers, conduct IMM waveform and marker processing, conduct ECG waveform processing, and detect artifa.cts, i.e., the measurable effect of successful IlvID functioning-ffie detection of the device ad,,,inistming tlicrapy, Other functions preferably implemented in the LEM may include the consolidation or synchronization of data to facilitate or enable display, storage, and networl, transuission.
Under this function, the LEM may poll various data sources, consolidate these sources -into a message, e.g., an XM, document, and transmit the data in a-consolidated statA
The LEM
may also effect data compression or encryption, where the data payload is identified or standardized in accordance with def ned component interface featturs. The LEM
may also preferably consolidate or synchronize-real-time data of various types or from varions sources, e.g., ECG and EGM graphical data, togetherwith.applicable annotationsIo these graphical data, in the form of artifact and marker annotations. These data, which in their native foimat may a,rrive at different rates or times, as they are collected by diffe,rent sensors and may be '1 S sampled at different rates; via the LEM.they may be synchronized and/or consolidated, and presented per one or more- component interfaces for transmission to various'client intztines;
' cIient" in this context meaning a requesting process generally, and not neeessariIy a client network node. In addition, the LEM, through its software or firmware, may detect or implement state changes in the interface instrument or IMD, provide real-time or continuous recording of ECG samples and IlVID waveform samples or markers, provide analog output of ECG or waveform samples, markers, or artifacts. This latter function, which may be considered a chart recording function, also preferably implements a report printing function which may be directly transmitted to a suitable display, plotter, or printer.
The LEM may also be implemented to accept analog input from IMDs for processing by the LEM
hardware unit or the interface instruinent overall. Another common function required for interface instruments that may be implemented and standardized within the LEM is the upgrade or loading of executable or object code as firmware or software for execution on the interface instrument's master processor, which does not reside within the LEM.
Similarly, the LEM
may provide upgrades to the flash memory or similar instruction RAM of the IMD
itself.
Peripheral software resident on interface instruments and other IMD peripheral devices may be implemented according to the invention to consist of two major parts: The first part is the peripheral subsystem running on the peripheral hardware or LEM. In order to incorporate the LEM into various interface instruments, a peripheral interface is developed for various interface instruments. The peripheral interface is implemented to run on that interface instrument's master processor, so that the functions of the LEM may be flawlessly incorporated into the functionality of the interface instrument as a whole. In this way, standardized LEM software components may be iinplemented and upgraded centrally using the coinponeiit interfaces already accessed by the interface instniment processor.
Various common fi.tnctions of interface instruments may be "componentized"
according to the present invention. In a preferred embodiment, for example, a Report Generator coinponent is developed that can execute within the Programmer or on other networked devices existing within a larger IMD administration network. This requires the device application, resident on the IMD itself, to export the required content in the agreed-upon format for the desired report. The user may then preferably be presented with the option to save the export image. hi this way, the user may generate reports at a later time in a remote location if desired. This present invention also may execute a Waveform Monitor within a larger IMD administration networlc. In this way, saved waveform information, as opposed to real-time data, may be accessed via various remote computing and communication devices that have access to the IMD administration and support network. For exainple, a user at a remote PC may execute a wavefonn monitor device and be connected to an active programmer interfacing with the Peripheral Component. In this case the user would be able to view a live real time waveform from an implanted device. Based on the common component architecture of the system, upgrades to the PC or other device user interface or analytic software may be changed and upgraded without regard to the programming of the IMD itself, of the LEM, or of the interface instrument. Likewise, any of these components may theinselves be reprogrammed without impact on the other elements, as long as the component interface definitions are respected. Other functions necessary for the functioning of an IMD administration networlc that may be implemented as component software modules within the LEM include the collection of real-time waveform data, e.g., ECG, EGM, and inarlcer notation indicating when an IMD has administered a treatment or is in some other relevant operational status. In addition, the LEM with component software may process waveform data and perform analysis or the data or display the output of the ECG, for example. While an hnplant Device Application may be changed, this will not have an impact on the LEM or any other networle node, as long as the "public" component definitions are respected by the developers of the Implant Device Application.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a schematic network diagram of an IMD administration network according to an embodiment of the present invention.
Figure 2 is a schematic diagram showing the hardware environment in which an embodiment of the present invention may be implemented.
Figure 3 is an architectural diagram for implementation of a software component system according to an embodiment of the present invention.
Figure 4 is an architectural diagram of an alternative embodiment of a software component system according to the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a component-based software architecture specifically adapted for enhancing the commi.ulication and interoperability of instruments and IMDs over a communications network, while providing a reusable and scalable software system that may be easily upgraded in a distributed fashion as new devices and fiuictionalities are developed.
The invention is preferably developed in a manner compatible with a communications network that implements a remote patient management systems that interact with remote data and expert data centers. At least some of the nodes of such a network are interface instrtiments, i.e., peripheral devices capable both of wireless commtmications with one or more IMDs in one or more patients, and of commtuiications over a computer network.
According to a preferred embodiment of the present invention, code reuse may be implemented between these interface instnunents, as well as within an instrument but across device applications. In this embodiment, software components may be generated which may have applicability to a number of different devices that an instntment may interface with.
Figure 1 depicts a typical IMD administration network 110 with which the present invention may be used, and as described in the related patent applications discussed above.
IMD 112 is in telemetric communication with IMD networlc interface 114. IlVID
112, representing one or more IMDs in one or more patients, may also or alternatively be in telemetric communication with progranuner 116, interface medical unit 118, or remote monitor 120. Prograinmer 116, interface medical unit 118, and remote monitor 120 are examples of interface instruments as described generally herein. IMD network interface 114 may be replaced by, or may have installed within, a Linlc Electronics Module, or "LEM" unit, discussed below. Programmer 116, interface medical unit 118, or remote monitor 120 may also have within an LEM unit. The IMD network interface device 114, or interface instrument 116, 118, or 120, or the LEM installed within such instrument, is either directly, or via the LEM or IMD network interface device 114, in communication with network 122.
Network 122 may be a public networlc, such as the Internet, if suitable security precautions are implemented such as firewalls 124. Through network 122 or other network connection, instrument 116, 118, or 120, directly or via internal LEM or IMD network interface 114, may communicate with centralized computing and monitoring computing resource 126.
Computing resource 126 may have access to relevant database 128 relevant to administration of IMD 112. This network, and interface instniments 116, 118, and 120, may also be accessed by remote patient, clinician, or other authorized user personal computer 130.
The positioning of a standardized hardware module, which may be termed a Linlc Electronics Module or LEM unit, which may be installed in interface instrument 114, 116, or 118 of Figure 1, is depicted in Figure 2 as a component,of and relation to IMD
networlc 210.
Preferably, software developed according to the invention may be optimized for use on this standardized hardware module 212 which may then be incorporated into any interface instrument (e.g. 116, 118, or 120 of Figure 1), providing component-based software functionality to the device. In a preferred embodiment, the LEM 212 will have the capacity to perform several typical functions common to various peripheral interface instruments regardless of the particular type of IMD 112 administered with the instrument.
For example, the LEM 212 may be configured to conduct telemetry communication with a deployed IMD
112 via transmitter/receiver 214, communicate with other IMD peripheral appliances such as Pacing System Analyzers 216, conduct IMD waveform and marker processing via processor 218, conduct ECG waveform processing, and detect artifacts. Other functions preferably implemented in the LEM may include the synchronization of data to enable display, storage, and network transmission, all effected on processor 218. In addition, the LEM, through its component software or firnlware stored in storage 220, may detect or implement state 5 changes in the interface instrument or IMD 112, provide real-time or continuous recording of ECG samples and IMD waveform samples or markers, and provide analog output of ECG or waveform samples, markers, or artifacts. This latter function, which may be considered a chart-recording fitnction, also preferably implements a report printing function which may be directly transmitted to a suitable display, plotter, or printer via modem or network interface 10 module 222. The LEM may also be implemented to accept analog input from IMDs 112 or other physiological monitoring equipment for processing by the LEM device or the interface instrument 116 overall. Another common function required for interface instruments that may be iinplemented and standardized within the LEM 212 is the upgrade or loading of executable or object code as firmware or software for execution on the interface instrument's master processor 224, which does not reside within the LEM 212. Similarly, the may provide upgrades to the flash memory or similar instruction RAM of the IMD
112 itself.
The primary function of the LEM with respect to the deployed IMD will be the downlinking of information requests, and the uplinking to the IMD administration network of the IMD's responses. The LEM 212 will have a similar information exchange relationship with Pacing System Analyzer 216, either via direct or networked communication, as depicted in Figure 2, or via telemetry. LEM 212 will downlink information requests to the Pacing System Analyzer (PSA) 216, and uplililc the responses of PSA 216, possibly after consolidating or integrating this data into waveform view information including ECG/EGM
graphical information and annotations.
Certain LEM functions may be provided in hardware or firmware, in addition to flash memory, in order to improve the speed or efficiency of the LEM 212. These functions may be implemented in a manner complying with component definitions, so that the resulting LEM 212 may be easily implemented in most or all interface instruments without modification or translation or the device instructions. A software or firmware module implementing an interface with peripheral interface component will be required in order to malce the LEM fiulctions work with the particular interface instrument.
The software architecture afforded by the present invention is depicted in Figure 3. A
component software system for IMD administration networks is shown at 310.
Implant device application 313 is resident within an implanted IMD, and executes on I1VID master processor 224 of Figure 2. Peripheral software components 314, 316 and 318 are resident on interface instruments such as 114, 116, and 118 of Figure 1, and other IMD
peripheral devices. These peripheral software coinponents 314 may consist of at least two major parts;
the first part being the peripheral subsystem running on the interface instrument hardware or LEM module within the interface instrument. In order to incorporate the LEM
into various interface instruments, a peripheral interface 314 may be developed for various interface instruinents. The peripheral interface may run on the master processor of the interface instrument, 224 of Figure 2, or within LEM processor 218 of Figure 2. In this manner, the functions of the LEM may be incorporated into the entire body of functionality of the interface instntment via interface compliant message passing between peripheral interface 314 running on interface instrument processor 224 of Figure 2, and peripheral subsystem running on LEM 212 of Figure 2. Standardized LEM software components may be iinplemented and upgraded centrally using the component interfaces already accessed by the interface instrument processor. LEM 212 may also provide for detection and reporting of relevant IMD state changes, -many of which may be generalized across IMD
types. LEM 212 may also flash or download executable code and configuration settings into storage of the remote interface instrument 116, 118 or 120 of Figure 1.
The component system according to the invention may provide for reusable modules which perform various common functions of interface instruments. A major common function required of most interface instruments is report generation. A Report Generator component 318 may be developed that can execute within the IMD programmer 116 of Figure 1, or other interface instrument 118 or 120, or within a larger I1VID
administration networlc, for example, on a remote machine 130 of Figure 1. In this way, report generation is no longer confined to, nor must report generation be coded to, a particular medical support device. Data, preferably after being synchronized and compiled, may be sent to a Report Generator Component software module that may be resident within an IMD
interface device, or within a network storage or processing device, and which may include, for example, remote personal computer 130 of Figure 1. Generally, those components on the top interface tier of Figure 3, i.e., Peripheral Interface Component 314, Live Waveform Monitor Component 316, and Report Generator Component 318, may be resident or executed on an interface instniment such as programmer 116 of Figure 1, or may be executed on a network device, including PC 130 of Figure 1, of other suitable device within IMD
information networlc 110. The networlced device running, for example, the Live Waveform Monitor Component 316 may view static waveform information that has been stored, or may view a real-time waveform monitor session via an active programmer or other interface device properly interfacing to the Live Waveform Monitor Component 316.
The device application 312 will be resident on the IMD itself. In this embodiment, the device application must export the required content in the agreed-upon format for the desired report to Report Generator component 318. The user may then preferably be presented with the option to save the export image. In this way, the user may generate reports at a later time in a remote location such as personal computer 130 of Figure 1 if desired. A component-based viewer may be provided in order to view the saved export image. This viewer necessarily uses the component frameworlc of the system as a whole, particularly as regards graphic display.
The report generation component accepts iinplant session data or follow-up session data and generates the user selected report. Preferably, user customization will be provided.
This customization may be implement locally, without impacting the operation of Report Generation Component 318. Only such information as the user has requested, and in the format requested, will be displayed to remote machine 130, according to component standardized requests for information, e.g., via message passing or function calls to public methods of the Report Generator Component 318, or via structured communications with Device Coinponent 313, as discussed herein with reference to Figure 4.
This present invention also may execute a Waveform Monitor Component 316 within a larger IMD administration network. In this way, saved waveform information, as opposed to real-time data, may be accessed via various remote computing and communication devices that have access to the IMD administration and support network. For example, a user at a remote PC 130 of Figtue 1 may execute a waveform monitor device via network interface 320, and be connected to an active programmer (e.g. 116 of Figure 1) interfacing with the interface instruinent. The live waveform monitor component 316 of Figure 3 accepts real time or static waveform data and presents an integrated view to the user. The user can control the number of waveforms (combination of surface ECG and implant device EGM ) along with markers and annotation information.
In this instance, the user would be able to view a live real-time waveform from an implanted device. Based on the common component architecture of the system, upgrades to the PC (130 of Figure 1), or other device user interface or analytic software may be changed and upgraded without regard to the programming of the IMD 112 itself, of the LEM 212, or of the interface instrument. Likewise, any of these components may themselves be reprogrammed without impact on the other elements, as long as the component interface definitions are respected.
An alternate software architecture embodiment of the present invention is depicted in Figure 4. Figure 4 depicts a Device component architecture generally at 410.
Device Component 313 operates centrally within IMD (112 in Figure 1) or interface instrument (114, 116, or 118 of Figure 1). This component is encapsulated and protected from direct access by interface components discussed herein. The Device Component 313 may communicate via any number of structured communications schema, such as those suitable for client-server or other message passing, or function calls and returns. Suitable examples include CORBA, a JavaBeans API, DCOM, XSLT, OAP, or XML. This latter schema, XML, or eXtensible Markup Language, is expected to prove particularly suitable for non-analog interfacing of the components of the instant invention. As depicted in Figure 4, Device Component 313 may send inforination and receive instructions from Controller/Viewer 412, which may be used for programming an IMD, or may interface via XML instructions and responses to Episode Viewer component 414, which may provide read-only access to IMD operation and physiologic infoimation to individuals having properly authenticated access to a network having access to Device Component 313. Device Component 313 may also interface with Trend Viewer Component 416, Paraineter Viewer 418, or Report Generator 318, which may operate in a manner similar to Report Viewer Component 318 of Figure 3. Device Coinponent 313 may also interface via XML using a defined instruction and parameter dictionary with Database, e.g. of patient history information, or with Industry Standard Style-Sheets formatting component 420. The various potential interfaces to which Device Component 313 may interface via XML, this standard is depicted generally by virtual central interface 421.
Device Component 313 may also be accessed by properly, authenticated individuals via Home Monitor Component 422 or Peripheral Interface Coinponent 314.
Peripheral Interface Coinponent 314 may operate in a manner similar to that described with reference to Figure 3. These interface communications may also be implemented using a structured, developer-defined, parsible communication schema such as XML. In a preferred embodiment of the present invention, real-time waveform data for a particular IlVID may be accessed by a remote computer (e.g. 130 of Figure 1), via Live Waveform Component 316.
Live Waveform Component 316 may transmit data from Live Waveform Viewer Component 424 via a communication schema suitable for pictorial/image data, in order to transmit analog graphical information regarding the IMD functions and effect, in order to compare programmed treatment with actual treatment as indicated by interventional artifacts. A
suitable scheme for transmission between components of this analog, or as transmitted what may be termed "pseudo-analog" pictorial representations, is Scalable Vector Graphics, or SVG, a mark-up language which is a W3C standardized grammar defined within the XML
language. Such analog representations, when transmitted to Waveform Viewer Component 316, will preferably include useful data including IMD marlcer and artifact indications on the surface ECG/implant device EGM data, as well as other relevant annotation information.
LEM 212 of Figure 2 will also preferably accept analog or pseudo-analog input from other Components which may feed relevant information for processing by LEM 212. The components of Figure 4, when implemented in accordance with the present invention as standardized interface components, may be individually developed, upgraded, replaced, and redesigned while respecting the interface definitions, such as those defined as XML tags, attributes, elements, or entities, collectively under an XML Document Type Definition suitable for transmission of IMD administration information.
While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the invention and the scope of the appended claims.
Claims (18)
1. A hardware module comprising:
a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing the hardware module to execute standardized software interfaces to medical device interface instruments and IMDs (Implantable Medical Devices) each medical device interface instrument and IMD using one of a plurality of programming platforms or languages; and means for communicating with a data communication network, the network comprising at least one medical device interface instrument and a plurality of IMDs, and with a medical device external to the hardware module, said hardware module being deployable to a plurality of medical device interface instruments.
a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing the hardware module to execute standardized software interfaces to medical device interface instruments and IMDs (Implantable Medical Devices) each medical device interface instrument and IMD using one of a plurality of programming platforms or languages; and means for communicating with a data communication network, the network comprising at least one medical device interface instrument and a plurality of IMDs, and with a medical device external to the hardware module, said hardware module being deployable to a plurality of medical device interface instruments.
2. The hardware module of claim 1, further comprising processing and telemetry means.
3. The hardware module of claim 1, installed within an interface instrument, to which the hardware module is deployable.
4. A computer readable medium for use in an IMD
(Implanted Medical Device) administration network in which one or more interface instruments are in communication with a plurality of medical devices applied to one or more patients, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing a computer to:
instruct or operate an IMD interface instrument;
utilize at least one software interface definition of a defined body of software interface definitions to communicate with at least one of the IMD interface instrument and the computerized IMD administrative network.
(Implanted Medical Device) administration network in which one or more interface instruments are in communication with a plurality of medical devices applied to one or more patients, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for causing a computer to:
instruct or operate an IMD interface instrument;
utilize at least one software interface definition of a defined body of software interface definitions to communicate with at least one of the IMD interface instrument and the computerized IMD administrative network.
5. A system comprising:
a computerized network of processing equipment with at least two nodes remote from each other, the network comprising a plurality of medical device interface instruments, each medical device interface instrument using one of a plurality of programming platforms or languages;
a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to the medical device interface instruments in the computerized network; and means for executing the computer readable code via the standardized software interfaces from remote processing equipment.
a computerized network of processing equipment with at least two nodes remote from each other, the network comprising a plurality of medical device interface instruments, each medical device interface instrument using one of a plurality of programming platforms or languages;
a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to the medical device interface instruments in the computerized network; and means for executing the computer readable code via the standardized software interfaces from remote processing equipment.
6. The system of claim 5, further comprising a hardware module capable of executing the computer readable code, said hardware module being deployable to a plurality of medical device interface instruments.
7. The system of claim 6, wherein said hardware module is integrated within at least one medical device interface instrument.
8. A component-based IMD administration and control instrument, comprising:
a master processing instrument having network communications capabilities for communicating with an IMD
administration and control network;
an electronics module having telemetry and processing capabilities installed within said master processing instrument; and a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to a plurality of medical device interface instruments in the IMD administration and control network, each medical device interface instrument interface using one of a plurality of programming platforms or languages.
a master processing instrument having network communications capabilities for communicating with an IMD
administration and control network;
an electronics module having telemetry and processing capabilities installed within said master processing instrument; and a computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to a plurality of medical device interface instruments in the IMD administration and control network, each medical device interface instrument interface using one of a plurality of programming platforms or languages.
9. The component-based IMD administration and control instrument of claim 8, wherein the master processing instrument comprises an IMD programmer.
10. The component-based IMD administration and control instrument of claim 8, wherein the master processing instrument comprises an IMD extender.
11. The component-based IMD administration and control instrument of claim 8, wherein the master processing instrument comprises an IMD interactive remote monitor.
12. An IMD monitoring and administration network environment implementing reusable and extendable computer readable code, comprising:
a plurality of IMDs, each using one of a plurality of programming platforms or languages, at least one of the IMDs being in communication with at least one IMD interface device; said at least one IMD interface devices having a computer readable medium in message-passing relation with at least one network interface, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to medical device interface instruments in the network environment;
said at least one network interface being in message-passing relation with at least one user node.
a plurality of IMDs, each using one of a plurality of programming platforms or languages, at least one of the IMDs being in communication with at least one IMD interface device; said at least one IMD interface devices having a computer readable medium in message-passing relation with at least one network interface, said computer readable medium having computer readable code stored thereon, said computer readable code being component-based and for implementing standardized software interfaces to medical device interface instruments in the network environment;
said at least one network interface being in message-passing relation with at least one user node.
13. The IMD monitoring and administration network environment of claim 12, wherein the message-passing relation between the computer readable medium installed on said IMD interface and said network interface is implemented by XML document transmission.
14. The IMD monitoring and administration network of claim 12, wherein the message-passing relation between the computer readable medium installed on said IMD interface and said network interface is capable of transmitting analog representations of patient waveform data.
15. The IMD monitoring and administration network environment of claim 14, wherein the analog representations of patient waveform data transmitted via the message passing relation between the computer readable medium installed on said IMD interface and said network interface is implemented by SVG document transmission.
16. The IMD monitoring and administration network environment of claim 14, wherein said computer readable medium further comprises a live waveform component; and a client live waveform viewer component wherein graphical information is transmitted from the live waveform component to the client live waveform viewer component.
17. The IMD monitoring and administration network environment of claim 16, wherein the graphical information is transmitted via a markup language.
18. The IMD monitoring and administration network environment of claim 17, wherein the graphical information is transmitted via SVG.
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