WO1997043004A1 - Programmably upgradable implantable medical device - Google Patents
Programmably upgradable implantable medical device Download PDFInfo
- Publication number
- WO1997043004A1 WO1997043004A1 PCT/US1997/008165 US9708165W WO9743004A1 WO 1997043004 A1 WO1997043004 A1 WO 1997043004A1 US 9708165 W US9708165 W US 9708165W WO 9743004 A1 WO9743004 A1 WO 9743004A1
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- WO
- WIPO (PCT)
- Prior art keywords
- patient
- functions
- arrhythmias
- arrhythmia
- time
- Prior art date
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37252—Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
- A61N1/37264—Changing the program; Upgrading firmware
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F8/00—Arrangements for software engineering
- G06F8/60—Software deployment
- G06F8/61—Installation
- G06F8/64—Retargetable
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- G—PHYSICS
- G06—COMPUTING; CALCULATING OR COUNTING
- G06F—ELECTRIC DIGITAL DATA PROCESSING
- G06F8/00—Arrangements for software engineering
- G06F8/60—Software deployment
- G06F8/65—Updates
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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
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S128/00—Surgery
- Y10S128/903—Radio telemetry
Definitions
- the present invention relates generally to implantable medical devices, and more particularly to such devices which are adapted for a capability to be upgraded or modified non-invasively while surgically implanted, through remote programming.
- the invention maintains the costs of the device and related implant procedures at a relatively reasonable level by limiting the device to the minimum primary life saving capabilities needed by the patient for current therapy.
- the implant is adapted to be upgradable, at additional cost, to allow the patient to receive the benefit of improved features or parameters of the device when, if, and as needed by the patient.
- the risks of surgery to implant these devices have been drastically reduced in recent years, as pointed out above, nevertheless there remains a risk anytime this type of surgery is performed, so that the patient receives an additional benefit if he or she need only be subjected to a non-invasive procedure to enable available but otherwise dormant features to be implemented.
- a solution to the problem is effected by providing a basic implantable defibrillator which — although it may be and preferably is capable of providing a variety of different cardiac arrhythmia or dysrhythmia therapies — for purposes of this summary is considered (at least initially) merely from the standpoint of its capability to deliver an electrical waveform defibrillating shock to the patient's heart (characterized herein as a "shock").
- the shock which is of predetermined appropriate current and voltage field gradient, is derived from the discharge of a capacitor in the device whose charging was commenced at the time that fibrillation was first sensed. Ideally, delivery of this shock to the heart will be effective to defibrillate the heart and return the heart rate to normal sinus rhythm.
- the conditions sought to be treated by the implant may not consist only of fibrillation.
- ventricular tachycardia may be experienced before fibrillation occurs that could, for an earlier episode, have been broken by antitachycardia cardiac stimulation or by automatic delivery of antitachycardia pacing pulses, but as a result of advanced disease of the patient, now requires a more rigorous, aggressive, or even adjunct therapy, such as VVIR rate adaptive pacing in order to improve an underlying cardiac hemodynamic condition as well.
- a patient may be desirable to turn on internally of the device several Holter monitor and memory functions that enable a more exact therapy to be delivered by the device according to the more tailored analysis of the patient's needs, and to program the device accordingly.
- a cardiac patient cannot easily tolerate the physical, mental, emotional, and economic toll of multiple operations which may range from an initial relatively simple implant device to successively more complex devices to meet the advancing needs for therapy dictated by progressive heart disease. The additional mortality and morbidity concerns upon the patient with repeated surgery could be devastating.
- the device is programmed and reprogrammed only as and to the extent that it becomes necessary to meet those needs when and as they may arise.
- the patient (or third party payor, if applicable) need make no initial financial outlay for the device itself beyond that required to cover the pricing for those features of the device which are made available at the time of implant, i.e., the therapy(ies) programmed for potential delivery to the implant patient to treat episodes of the diagnosed arrhythmia(s) for which treatment is currently prescribed. Thereafter, additional device charges will be imposed only to the extent that additional features are required to treat specific manifestations of an advancing disease or new disorder, and are actually programmed into the device. Accordingly, the patient's account is not addressed for features which, though available within the device itself by proper programming, are presently unused and not a part of the therapy which has been provided by the device to date.
- the device need merely be made capable of performing the basic therapeutic needs required by the patient, in addition to delivering a life saving shock.
- the basic needs may, for example, include or be limited to the delivery of a pacing function for a slow heart rate in response to detection of the need for such therapy.
- the device possesses the further capability to be adjusted later to meet additional needs of the patient with the passage of time -- importantly, without a requirement for additional surgical procedures for replacement of the device.
- the solution to the problem is that initially the implanted device is provided with very basic features from among those that it is capable of delivering.
- the device possesses means that enable it to be upgraded non-invasively and successively, whenever the requirement exists for additional therapy (ies) to be delivered to meet the patient's additional needs.
- a serious problem encountered in the use of such an upgradable device resides in the manner in which safeguards will be employed to preclude access to externally programmable software control registers and, thus, for upgrading - or indeed, in any way modifying - the features of the implanted device by anyone other than an authorized person.
- the authorized person is the patient's attending cardiologist.
- the device is encoded in a suitable manner to lock it against access to those of its internal programs which relate to upgrades, i.e. , the addition (or even selective removal) of therapies, except to an authorized person in possession of a key to unlock the access - generally, the physician.
- the key(s) to unlocking the code are supplied by the manufacturer of the device.
- the necessary programming changes might be made from time to time by the manufacturer, such as by modem, when called upon to do so by, and in consultation with, the patient's physician.
- certain functions which have customarily been made programmable in conventional implanted devices to allow changes, selections, activation, or deactivation by the physician (or in some case, by the patient, as well) would not be affected. That is, programming those functions would continue to be handled in the same manner as before, without need for the special codes or keys that mark the security for an upgradable device.
- the upgrading is performed by identifying the serial number of the device to allow a certain code to be addressed by programmer software.
- the upgrade data may be through a service of the device manufacturer delivered by key file via Internet, E-mail, or telephone modem transfer, or any other communication means presently available or subsequently developed, so that the device can be programmed with additional software information and that additional functions, otherwise dormant (through blocking) but available, in the device can be activated.
- the additional cost of the full, more complex device will be saved at the outset for those patients who require only selected basic ones of the features built into the device — and who are not primarily identified as candidates for sudden cardiac death but are only at risk without ever going into ventricular fibrillation, and in whom there is no actual need to bear the cost of the more expensive and complex (i.e., full featured) device at that time but for whom the basic device will suffice for the present.
- the cost of a basic device in current dollars could be reduced to less than SI 0,000, while the additional upgrade might cost another $8,000-10,000, in comparison to a typical cost of $15,000 for a basic function defibrillator device and a cost of $20,000 for a typical upgrade replacement unit.
- a further aspect of the present invention is the provision of a graded upgrade — which means that certain functions such as Holter monitor-type, or certain pacing functions such as antitachycardia pacing functions, extended memories, and so on can be turned on and activated individually depending on how much the physician determines to be needed for a particular patient.
- the reimbursement cost and any additional cost to activate the device in this manner are based on the amount of additional intelligence and service required for the activated, upgraded unit as implanted.
- FIG. 1 is a block diagram of an exemplary embodiment of the presently-contemplated best mode of practicing the invention, in the form of an implantable cardioverter/defibrillator device;
- FIG. 2 is a chart of characteristics for the device of FIG. 1, and capabilities of an external programmer for reading and programming memory associated with the device;
- FIG. 3 is a flow diagram for the external programmer application software;
- FIG. 4 parts A, B, and C, are functional block diagrams useful in further explaining the preferred embodiment of a device implemented according to the invention, and the preferred method of providing arrhythmia therapy using the device.
- FIG. 1 is a block diagram of an exemplary embodiment of the invention, in the form of an implantable cardioverter/defibrillator device 10, all of the components of which may be entirely conventional except as otherwise described herein.
- Device 10 is constructed and adapted, according to the principles of the invention, to be upgraded from time to time. The upgrading is to be performed as may be necessary to enable the device to provide additional therapy for treatment of arrhythmias in a patient (not shown) in whom the device is to be implanted, as the needs of the patient for such treatment undergo change with the passage of time.
- Device 10 includes a function generator 16 which constitutes means for providing a plurality of functions corresponding to different levels of therapy for treatment of arrhythmias.
- the function generator may be of known construction to generate various types of relatively low energy pulse waveforms for pacing therapy such as antitachycardia pacing, moderate energy cardioverting shock waveforms for cardioversion therapy, and relatively higher energy defibrillating shock waveforms for defibrillation therapy, as well as any other arrhythmia treatment signals.
- Function generator 16 may, and generally will, include an output circuit (not shown) for delivering the designated therapy to the appropriate set of heart leads and electrodes.
- the output circuit may include capacitors and high voltage switches that enable the higher energy defibrillating shocks to be applied to electrodes that will establish the necessary electric field through the mass of the heart encompassing the chambers (e.g., the ventricles) which are to be defibrillated.
- the electrodes used for applying the various electrical waveforms for arrhythmia therapy may include the biocompatible metal housing (i.e. , the case, or "can") of device 10 itself — the housing being indicated by the dotted lines in the Figure -- as an active electrode, if desired for a particular type of therapy.
- the function generator 16 performs its therapy-generating and delivery functions under the control of a microprocessor or microcontroller 15 which is a single-chip (semiconductor integrated circuit) system containing arithmetic, logic, and control circuitry for general purpose data processing or computing, and operating in conjunction with on- or off-chip peripheral circuits or subsystems such as memory, clock, and so forth, to constitute a central processing unit (CPU) for the device.
- Microprocessor 15 is sufficiently powerful to respond to a multiplicity of pre-programmed or programming instructions to perform high speed, real-time functions by which to control the operation of function generator 16.
- the on-chip or off-chip memory may be programmed, and together with the capability of separate telemetry programming from a program console through a wand 25, and related software or firmware, allows the microprocessor to perform functions which may be varied by means of a programming unit, or programmer, such as by the device manufacturer or the patient's attending physician.
- a sensing means 12 is provided to detect various physiologic parameters indicative of the patient's cardiac functions and physical status, so as to sense different types of arrhythmias and initiate appropriate response mechanisms from the device.
- the sensing means may be located within the device 10 housing, as shown, or outside the device in its own implanted housing (not shown), or in some instances, even external to the patient, or partly inside and partly outside the device 10 housing.
- the sensing means is preferably capable of detecting the patient's electrogram (ECG) and supplying signals indicative of functions including heart rate and rhythm, as well as parameters indicative of exercise or activity of the patient, so that the device 10 may provide a rate adaptive response to the status of patient activity as well as to perform the other arrhythmia correction therapies which have been mentioned.
- Signals generated by the sensing means 12 are converted to digital form and supplied to the microprocessor 15 to modulate the performance of the latter and its control over the operation of the function generator 16.
- the microprocessor 15 responds to each different type of arrhythmia sensed by sensing means 12 (as well as to other relevant physiologic parameters detected by the sensing means, such as patient activity) for enabling the function generator 16 to provide a functional output waveform which is appropriate to correct or otherwise treat the respective sensed arrhythmia.
- Some of these functional output waveforms may be used without change for application to several different types of arrhythmias. For example, a burst of pulses may be generated as a therapy to terminate a tachycardia, and may also be one among a hierarchy of responses which are selectively delivered in a cardioversion program.
- the microprocessor may revert to a "sleep" mode, subject to be awakened at any time that a therapy requirement is indicated, such as by the sense signals.
- means 17 are provided for programmably disabling at least some of the several, or plurality of, functions that may be delivered by device 10 by virtue of the operation of the components including microprocessor 15 and function generator 16. That is, the device 10 is implemented to provide a variety of therapies as has just been described (i.e. , is a "full featured" device), and as may be found in any number of prior art medical devices for treating cardiac arrhythmias. However, the device 10 is also provided with a means by which its capability to deliver all of the functions is curtailed, but is nevertheless sufficient to address the present needs and demands of the patient in which it is, or is to be, implanted.
- the device may be programmed to deliver an anti-tachy therapy -- which may include a number of different treatment waveforms that are delivered in a sequence ranging from a conservative response to an aggressive response, but restricted to that malady.
- an anti-tachy therapy may include a number of different treatment waveforms that are delivered in a sequence ranging from a conservative response to an aggressive response, but restricted to that malady.
- the patient has the full featured device implanted, but programmed only with the anti-tachy therapy.
- the implant might instead have been a device which was manufactured to provide only that identical anti-tachy therapy, and with no capability whatsoever to be upgraded to provide any other or any additional therapy.
- the patient or third party payor, whether insurance carrier or otherwise
- device 10 further includes means 20 for selectively restoring the disabled functions, which preferably also includes security means for encoding the device to preclude the restoration of disabled functions (or any other modification of device features), except by an authorized entity.
- security means is implemented to require participation by both the attending physician and the device manufacturer to effect an upgrade.
- device 10 is provided with a security system to prevent it from being reprogrammed without an appropriate key or keys, which will be described presently.
- each upgradable device should not be recognized by existing applications in the field. This means that no interference or override should occur through existing or future programming or device operation which is or will be available from the device manufacturer.
- Each upgradable device should have its own unique personal identification code, or identifier (ID), which should be embedded in the device in nonvolatile memory so that it will not be erased in the event of a loss of electrical power to the device (which, of course, is provided by battery).
- ID personal identification code
- a compatibility determination check (i.e., to assure compatibility between the upgradable device and the external programmer, particularly with respect to software of each) may be performed by retrieving or verifying the nonvolatile ID (which may, for example, be the serial number of the device) plus a volatile ID (which may, for example, be the model number of the device).
- the latter ID is embedded in programmable memory to allow it to be reprogrammed in the event of corruption.
- a data memory of the device has a location which identifies the level at which the device is currently upgraded (i.e., the enabled features), based on the state of the device software.
- the upgrade level may be read at any time by the attending physician to verify the current status of the device; and may be written to in order to reprogram the device to a new upgrade level.
- An error detection code is provided, which can be read to detect errors, and written to correct errors.
- the device is implemented with a backup reset feature.
- the device is reset to a full-featured device (from a partial-featured mode), but requires programming of the authorized upgrade codes at a later date for all features to remain active.
- the device may be reset to a predetermined limited functional mode, and the user prompted to obtain upgrade codes from the manufacturer. Both options will allow instantaneous restoration of critical feature for patient safety, while preventing unauthorized upgrading of the device. Only the minimum life saving functions or features, such as defibrillation shock and bradycardia backup pacing need be restored by a reset module. Additional features could be upgraded with special access module programming.
- Such capabilities are illustrated, for the preferred embodiment, in the chart of FIG. 2.
- the device 10 characteristics are on the left, the external programmer (with wand 25) is on the right, and the communication direction is illustrated by the lines and arrows between the two. All of the listed characteristics or parameters for the device are stored in read-only memory (ROM) and random access memory (RAM) associated with the device.
- ROM read-only memory
- RAM random access memory
- the device software supports the full range of features available with all combinations of upgrades.
- the external programmer uses the volatile control parameters of the device software to enable, disable, or limit the range of features according to the selected upgrade level.
- FIG. 3 A flow diagram for the external programmer application software is illustrated in FIG. 3. An inquiry is made to the device from the external programmer (the programming console) to read the device ID and to determine therefrom the compatibility of the device with the application software of the external programmer. If compatibility does not exist, a flag or message is displayed to that effect on a display of the programmer. But if the two are compatible, a further test is made to determine whether the ID/upgrade level data are corrupt. If any of the data is corrupt, the user (physician) is instructed to get the security code. Otherwise, the user is notified (also on the display) that programming is permitted to the extent of the upgrade level. Certain of the features may be limited in range or availability. In FIG.
- parts A, B, and C illustrate aspects of the control over features of the device by the external programmer.
- a security code constituting a key e.g., key 1, key 2, key 3, etc.
- the appropriate key (security code) in each instance is supplied by the device manufacturer, upon notification from the attending physician for the implant patient that the device is to be reprogrammed to modify the original feature or a subsequently upgraded version to meet the patient's current needs for cardiac arrhythmia therapy.
- the modification can be accomplished on a non-invasive basis by simply applying the new programming to the implanted device through the external programmer and telemetry after the key has been provided.
- the manufacturer is assured of being notified before any adjustment can be made to the features of the device.
- a charge may then be imposed for the additional feature(s), or the upgrade, to compensate the device manufacturer for the original implementation.
- the cost to the patient is considerably less than would have been the case had the implanted device required replacement, and the risk and trauma to the patient are substantially eliminated.
- each feature is controlled by the upgrade code, which includes the respective key and the program for that upgrade/feature.
- the upgrade code includes the respective key and the program for that upgrade/feature.
- a feature 1 is programmed "on", while a feature 2 is disabled to be “off”.
- Other features may be left or restored to be “on” or disabled to be “off” as necessary to provide the device capabilities that will meet the needs of the patient.
- a display 32 may be provided on the programmer monitor to show the feature matrix as currently programmed.
- An upgrade code (another key) is applied in FIG. 4B to enable (or restore) feature 1, while leaving feature 2 disabled.
- the external programmer 40 interrogates the device 10 for model number (at 42) and serial number (at 43), and, if the response indicates that the compatibility is positive, checks the upgrade level (at 44) of the device and applies an upgrade code (at 46, to manage the availability of certain features defined by sections of the software, by restricting or allowing access with software keys) for installing (restoring) the additional features required according to the patient's condition.
- a check sum is performed by the programmer (at 48) to detect and correct errors. Having unlocked a feature or features with the applicable key, those unlocked features among 1, 2, ... N, may be programmed or restored as necessary to provide the features (the therapies) required to treat the patient's cardiac arrhythmias as prescribed by the attending physician.
- the upgrade information is stored in software or semiconductor memory in the device, and is encoded to deter intentional alteration. This is accomplished preferably by storing a value which is a complex mathematical combination of the upgrade level, the device model number, and the device serial number, so that the upgrade level value stored is then unique for each device.
- This upgrade information, along with the model and serial number information for the device, is protected by an error detection code.
- this error detection code is a checksum, which will allow the application program to recognize alteration or corruption of the serial number or the upgrade level.
- the application displays the serial number and upgrade level correction screen on the console, to prompt the user to contact the manufacturer for a security code.
- the upgradable device is adapted from an existing conventional device design, with customized programmer software architectures that minimize modifications to existing conventional programmer application code and device code.
- the graded upgrading may apply to each individual function of the device, so that each such function when programmed into the device carries with it a particular imposition of a charge to the patient's account. Such charges would be imposed for each new function until the device is made fully operational, i.e., the full range of its features are made available to the patient.
- Additional charge would apply, for example, to the provision of extended memory, WIR pacing (rate adaptive), VDD pacing, anti-tachycardia pacing, atrial defibr illation, programmable polarity of the shock, programmable impulse characteristics of the shock, and other diagnostic and therapeutic features.
- the present invention goes beyond the use of an external programmer to provide data to preselected registers and RAM memory locations within an implanted medical device, such as a pacemaker or defibrillator, which affect either the sections of software routines to be executed or the parameters to be used in that execution.
- the invention represents an enhancement extending to a method and system of managing the availability of certain sections of the software which constitute operational features of the device by restricting or allowing access to those features (through the applicable sections of the software) by means of software keys.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE69732105T DE69732105T2 (en) | 1996-05-16 | 1997-05-14 | PROGRAMMABLE, IMPLANTABLE, MEDICAL DEVICE |
EP97926498A EP0906137B1 (en) | 1996-05-16 | 1997-05-14 | Programmably upgradable implantable medical device |
JP09541102A JP2000510733A (en) | 1996-05-16 | 1997-05-14 | Implantable medical device that can be programmably upgraded |
CA002255653A CA2255653C (en) | 1996-05-16 | 1997-05-14 | Programmably upgradable implantable medical device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/648,707 US5725559A (en) | 1996-05-16 | 1996-05-16 | Programmably upgradable implantable medical device |
US08/648,707 | 1996-05-16 |
Publications (1)
Publication Number | Publication Date |
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WO1997043004A1 true WO1997043004A1 (en) | 1997-11-20 |
Family
ID=24601899
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/008165 WO1997043004A1 (en) | 1996-05-16 | 1997-05-14 | Programmably upgradable implantable medical device |
Country Status (6)
Country | Link |
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US (2) | US5725559A (en) |
EP (1) | EP0906137B1 (en) |
JP (1) | JP2000510733A (en) |
CA (1) | CA2255653C (en) |
DE (1) | DE69732105T2 (en) |
WO (1) | WO1997043004A1 (en) |
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JP2000510733A (en) | 2000-08-22 |
CA2255653C (en) | 2005-12-27 |
DE69732105T2 (en) | 2006-05-18 |
US5725559A (en) | 1998-03-10 |
DE69732105D1 (en) | 2005-02-03 |
US6073049A (en) | 2000-06-06 |
CA2255653A1 (en) | 1997-11-20 |
EP0906137A1 (en) | 1999-04-07 |
EP0906137B1 (en) | 2004-12-29 |
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