Method and apparatus for establishing context among events and optimizing implanted medical device performance

An apparatus and method for adjusting the performance of an implanted device based on data including contextual information. Contextual information, including operational and performance data concerning the implanted device as well as the patient with the implanted device, is stored by a portable electronic device. In one embodiment, the portable electronic device is adapted for battery operation and includes a personal digital assistant (PDA). The portable electronic device is adapted for use as an interface to conduct wireless communications with the implanted device. In one embodiment, the portable electronic device interfaces with a clinical programmer for use by a physician.

TECHNICAL FIELD

The present subject matter relates to implantable devices and more specifically, to a method and system for optimizing performance of an implanted medical device based on contextual information derived from the implanted medical device, external sensors, user provided data, or other sources.

BACKGROUND

A normal, healthy, heart beats at a regular rate. Irregular heart beats, known as cardiac arrhythmia, on the other hand, may characterize an unhealthy condition. Another unhealthy condition is known as congestive heart failure (“CHF”). CHF, also known as heart failure, is a condition where the heart has inadequate capacity to pump sufficient blood to meet metabolic demand. CHF may be caused by a variety of sources, including, coronary artery disease, myocardial infarction, high blood pressure, heart valve disease, cardiomyopathy, congenital heart disease, endocarditis, myocarditis, and others.

Unhealthy heart conditions may be treated using a cardiac rhythm management (CRM) system. Examples of CRM systems, or pulse generator systems, include defibrillators (including implantable cardioverter defibrillator), pacemakers and other cardiac resynchronization devices.

Typically, a pulse generator is surgically implanted under the skin, but outside the thorax of a patient and includes one or more conductive lead wires that deliver an electrical pulse to the heart according to a therapy schedule. The electrical pulses may be delivered on a predetermined schedule, on an as needed basis, or according to other predetermined criteria.

In some cases, the operation of the pulse generator may be adjusted using an external programmer. The programmer allows a physician to tailor the performance of the pulse generator without performing surgery on the patient. The programmer may communicate with the pulse generator by wireless technology such as radio frequency communication.

A typical programmer includes a wand coupled to a desktop unit by a flexible electrical cord. In use, the operator positions the wand near the implanted device and a signal from the programmer is wirelessly transmitted to the device. Data is extracted from the transmitted signal and stored in internal memory within the implanted device. The implanted device then delivers therapy according to the memory contents. The memory contents may include operating parameters or programming. For example, the implanted device may be wirelessly programmed to deliver electrical shocks at a greater amplitude or with greater frequency.

The ability to wirelessly program an implantable device has taxed the performance and capacity of device data storage and the device power supply and also compelled the addition of a transceiver suitable for communicating with the programmer. To address these needs, some manufacturers have adapted their devices to include additional circuitry as well as increased battery capacity. To the chagrin of the patient, such improvements have, in some instances, resulted in larger case sizes for the implantable device.

Consumer, and therefore, manufacturers, of implanted medical devices have demonstrated a clear desire for, among other things, reduced device size, increased functionality, and increased reliability and longevity. Efforts to provide increased functionality and increased reliability have tended to frustrate the objective of reduced device size. Thus, there is a need for an implanted device with reduced size and yet permits field programmability along with increased reliability.

At initial implantation, the medical device is programmed to provide therapy based on known parameters and conditions of the patient. Follow-up programming of the implanted device, which may take place at a doctor's office, may be based on stored data and patient input. However, for many patients, follow-up visits are infrequent and thus, patients are unable to provide their physician with accurate or complete information regarding the events surrounding a particular cardiac event. For example, few patients are able to provide reliable data concerning their dietary intake just prior to a period of increased heart rate that may have occurred three weeks ago. Thus, there is a need for collecting timely patient data with improved accuracy.

SUMMARY

The present subject matter includes, among other things, a system and method for collecting timely data from a variety of sources and correlating the data with data provided by an implanted medical device. In one embodiment, patient responses are collected using a portable device. The portable device may present questions or data entry prompts or otherwise solicit a response from the patient. The prompts may concern subjective or objective data. In one embodiment, the questions include “Have you felt dizzy in the last two hours?,” “Are you breathless?,” “Do you feel palpitations?,” “Do you have any chest pain?,” and “How many alcoholic drinks have you consumed in the previous 2 hours?” In one embodiment, data from a sensor coupled to the implanted medical device is communicated to the portable device. The data includes physiological information concerning the performance of the implanted medical device or measured parameters concerning a particular body organ or system. In one embodiment, data from a sensor not coupled to the implanted medical device is communicated to the portable device.

By way of example, in one embodiment, the patient is implanted with a medical device as part of a cardiac rhythm management (CRM) system. The CRM system includes a pacemaker defibrillator with an accelerometer and heart rhythm sensor. In addition, the patient is also fitted with an implanted respiration monitor with in the CRM system. In this example, the portable device, which is carried external from the body of the patient, prompts the patient with questions concerning such topics as their sleep patterns, dietary and drug intake, visible edema and other relevant signs and symptoms. The portable device also receives data from the defibrillator with the accelerometer, heart rhythm monitor and the respiration monitor.

At a clinical setting, or by a remote communication coupling, the patient's doctor can access the portable device and retrieve the stored data from the various inputs. The retrieved data can be analyzed for trends as part of a wellness monitoring system and therefore, enable improved medical care and reduce healthcare utilization.

In one embodiment, the portable device is coupled to, or incorporated within a personal digital assistant (PDA). Thus, the PDA communicates wirelessly with an implanted medical device as well as communicates with a programmer. In addition, the portable device is adapted to execute instructions that prompts the user for information and stores the responses. In one embodiment, the user entered data is received in response to a prompt or message. In one embodiment, the user is able to enter data in a free-text entry mode without regard to a particular schedule. In one embodiment, the portable device also receives data from non-invasive sensors or detectors. Examples of non-invasive sensors include an arterial blood pressure monitor, a respiration monitor, a blood sugar detector, a body mass scale as well as other devices. The portable device communicates with the non-invasive sensors or detectors in a wireless manner or via a wired coupling.

In one embodiment, the portable device may receive data from an implanted device other than that which is controllable by way of the programmer. For example, a patient may be equipped with an implanted cardiac pacing device as well as a separate implanted sensor for monitoring a body parameter or organ and the portable device receives data from both implanted devices and yet the programmer interfaces with and controls the operation of the cardiac pacing device and not the separate implanted sensor.

In various embodiments, the portable device is coupled to a PDA, (variously referred to as a personal digital, or data, assistant), a portable telephone (including a cellular telephone or a cordless telephone), a pager (one way or two way), a handheld, palm-top, laptop, portable or notebook computer, or other such battery operated portable communication device, all of which are herein referred to as portable communicators.

In one embodiment, the portable device operates independently and without coupling to a portable communicator. It will be appreciated that either the portable device or the portable communicator may provide the data storage capacity, processing, display, or user input means as described herein.

In one embodiment, the portable device includes circuitry or executable programming and communicates wirelessly with the implanted medical device. In one embodiment, the portable device is coupled by a wired link to a remote programmer or other network communication device. In one embodiment, the device includes a separate module that communicates wirelessly with the implantable medical device and the separate module is user-removable from the portable device.

The present subject matter also includes a method and apparatus to allow a portable communicator, such as a PDA or cellular telephone, to interface between an implantable medical device and a programmer. The programmer may be coupled to the portable device by a network communication connection. For example, in one embodiment, a remote programmer can access a cellular telephone coupled to a portable device via the Internet, a private area branch exchange (PABX, also known as a PBX), an intranet network, an ethernet connection or other remote communication means. In one embodiment, the portable device is coupled to a portable telephone with which the programmer communicates using a public switched telephone network (PSTN) and the portable telephone is in wireless communication with the implantable medical device.

The present system may allow increased data logging, thereby permitting analysis otherwise not possible using the limited data storage capacity and battery capacity of an implanted device.

DETAILED DESCRIPTION

In accordance with the present system,FIG. 1Aillustrates patient455implanted with implantable medical device25coupled to heart15A by leads20A and20B. In one embodiment, the combination of leads20A and20B and device25provides cardiac rhythm management pulsing and also senses one or more physiological parameters of heart15A. Implantable medical device25communicates wirelessly with portable device35shown in the left hand of patient455. Portable device35is external to the body of patient455and, in the embodiment shown, is coupled to portable communicator80. In one embodiment, portable communicator80includes a PDA.

In one embodiment, implantable medical device25provides data including heart rhythm, breathing, activity, and contractility, as illustrated at450. Other types of data derived from implantable systems are also contemplated, as noted at450. For example, in one embodiment, a respiration sensor is implanted into patient455and communicates with portable device35. Data received from such implantable systems may be perceived as involuntary, or passive, data since the patient has no control over the process of collecting and transmitting the data from such sources.

In one embodiment, portable communicator80includes a touch-sensitive display screen for displaying information to a user or patient455. Depending on the application executing on portable communicator80, the display screen may provide prompts, messages, questions, or other data designed to elicit an input from patient455. For example, in one embodiment, portable communicator80may display a screen shot as shown at400. Screen shot400, entitled “Non-invasive Data Entry Screen” provides links to questions or prompts as shown in the figure. Data received from such interactive prompts may be perceived as voluntary, or active, data since the cooperation and active input of the patient is part of the data collection process. The user voluntarily provides answers in response to prompts that appear on the screen. At each of405through445, the patient may be linked to one or more questions concerning the general topic appearing in screen shot400. For example, at405, the link “Blood Pressure” may lead to one or more questions concerning the patient's blood pressure. At410, the patient may be prompted for information concerning their body weight. At415the patient may be prompted to supply data concerning their sleep patterns (bedtime, sleep time, perceived arousals, perceived sleep quality) or recent life experiences. At420, the patient may be prompted for data concerning their perceived quality of life (Q of L). At425, the patient may be prompted to supply information concerning their perceived physical strength. At430, the patient may be prompted to supply information regarding their mental acuity. In one embodiment, the patient may be presented with a series of short questions and based on the responses received, portable communicator80calculates a parameter corresponding to mental acuity. At435, the patient is prompted for data concerning their dietary intake. At440, the patient is prompted for data concerning their voiding patterns. At445, the patient is prompted to supply information concerning drug therapy compliance.

Wellness monitoring system460is in communication with portable communicator80, and thus, portable device35. Wellness monitoring system460provides analysis of voluntary and involuntary data gathered by portable device35. In one embodiment, wellness monitoring system460includes computer and programming that conducts data analysis and identifies trends that may improve patient health and medical care.

FIG. 1Billustrates a screen shot of questions that may be posed in one embodiment. Questions and prompts appearing on a display coupled to portable device35may concern objective or subjective matter. Questions and prompts illustrated in the figure, concern the topics of exercising, prescribed medications, non-prescription drug intake, alcohol consumption and recent sleep patterns, however it will be appreciated that those shown are exemplary only and that other questions or prompts may also be used. In one embodiment, prompts are used in lieu of questions. For example, a prompt concerning exercising may be presented as “Enter the number of minutes and intensity of walking on a treadmill” thus calling for the user to enter numbers and/or levels of intensity on an analog scale.

FIG. 1Cillustrates a screen shot of questions concerning alertness, unusual sensations, chest pain, anxiety, and stress. As noted other questions or subject matter may be presented to the patient.

FIG. 1Dillustrates a screen shot of questions directed to eating a balanced diet, lethargy, insomnia, voiding patterns, and drug and dietary supplement intake.

FIG. 1Eillustrates a screen shot of questions directed to exercise plans, recent alcohol consumption, weight relative to a target body weight, signs of edema and breathing difficulty (such as unexpected shortness of breath).

FIG. 1Fillustrates, in block diagram form, an embodiment of the present system. In the figure, system10is shown to include an implantable medical device, here marked IMD25, which is shown coupled, by lead20, to heart15. In one embodiment, IMD25includes an implantable cardiac device (ICD), CRM device, pulse generator, or other implanted medical device that provides therapy to a patient or an organ of a patient, or that provides data derived from measurements internal to a patient. In the figure, IMD25is further shown coupled to portable device35by link30. In one embodiment, portable device35includes a portable communicator. Portable device35is further coupled to programmer45by link40.

In one embodiment, lead20includes a catheter or other implanted lead having one or more electrodes for the delivery of electrical energy to selected portions of an organ, or tissue, of a patient or for receiving electrical signals indicative of the health of the patient or a selected organ. In one embodiment, lead20is coupled to a human or animal heart, however, other organs may also be monitored or treated. In one embodiment, the housing of IMD25is electrically conductive and serves as an electrical conductor and operates in conjunction with a signal on a conductor portion of lead20.

In one embodiment, IMD25includes a pacing device (commonly referred to as a pacemaker) a defibrillator, heart failure therapy device, cardiac resynchronization device or other medical device. In one embodiment, IMD25also includes circuitry and programming adapted to monitor the condition and performance of the pulse generator or other implanted device. For example, in one embodiment, IMD25provides data concerning the remaining battery condition for a power supply coupled to IMD25. Such data may include information regarding remaining battery capacity or life, battery internal resistance or other measurable parameter. In other embodiments the data includes information regarding the electrical therapy provided by IMD25. For example, in one embodiment, such data includes the peak voltage level, the rate, or frequency, of therapy, the profile of the delivered shock or other parameters. In various embodiments, IMD25is controlled by digital or analog signals and in one embodiment, IMD25generates data in digital or analog form.

In one embodiment, IMD25includes a program executing on an internal processor that controls the operation of the device. The program instructions reside in a memory accessible to the internal processor. By changing the program, or memory contents, the present system allows the operating program of IMD25to be dynamically tailored to a particular patient or condition. In one embodiment, the operating system, or memory contents of IMD25can be changed using wireless communication.

In one embodiment, IMD25includes a wireless transceiver. The transceiver operates using radio frequency transmissions, electromagnetic transmissions, magnetic coupling, inductive coupling, optical coupling, or other means of communicating without need of a wire connection between IMD25and another transceiver. In one embodiment, IMD25is coupled to a wireless transceiver by a wired connection.

In one embodiment, IMD25performs a data acquisition function. For example, a detector coupled to IMD25is adapted to monitor a fluid pressure, such as blood or urine. In one embodiment, the detector is adapted to monitor respiration, stress level, or other measurable biometric parameter. In one embodiment, monitoring includes determining an absolute or relative value for a particular biometric parameter. Internal memory within IMD25may be adapted to store a comparison value which may then be compared with a measured value thereby determining the performance of IMD25or the health of the patient.

Link30is a wireless communication link between IMD25and portable device35. Link30allows communication in one or two directions. For example, in one embodiment, data from IMD25is communicated to portable device35with no data transmitted from portable device35to IMD25. In this manner, portable device35functions as a data storage facility for IMD25. In one embodiment, data stored in portable device35can be accessed by a treating physician and used for diagnosis, therapy or other purposes. Programming and controlling the operation of IMD25is performed using a programmer adapted to transmit commands, data or code to IMD25. In one embodiment, portable device35, or portable communicator80, executes programming to analyze and process the data received from IMD25. In one embodiment, communication link30may preclude transfer of data from portable device35to IMD25or to preclude transfer of data from IMD25to portable device35. For example, in one embodiment, portable device35executes programming which automatically adjusts the performance or operation of IMD25independent of programmer45and under certain predetermined conditions, it may be desirable to preclude such automatic adjustments.

In one embodiment, data is communicated from portable device35to IMD25with no data transmitted from IMD25to portable device35. In this manner, portable device35functions as an interface to communicate commands, data or code to IMD25.

In one embodiment, data is communicated bidirectionally between IMD25and portable device35. In various embodiments, link30entails a single bidirectional communication channel or includes multiple unidirectional communication channels which, when viewed as a whole, provide bidirectional communication. In one embodiment, a unidirectional communication channel operates using a particular frequency or communication protocol. For example, link30include a wireless radio frequency link compatible with a transmitter and receiver that uses frequency hopping, spread spectrum technology.

In one embodiment, internal memory within IMD25provides storage for data related to the CRM therapy provided to heart15. The data may relate to the electrical, chemical or mechanical operation of the heart. In addition, IMD25includes memory for programming, comparison and other functions. In one embodiment, the contents of the memory regulates the operation of IMD25.

In one embodiment, portable device35is coupled to a battery operated portable communicator having a processor, memory, and an output interface to communicate with a user and an input interface to receive user entered data. One suitable example of a portable communicator is that of a PDA. Commercial suppliers of PDAs include Palm, Inc. (Santa Clara, Calif.), Microsoft Corporation (Redmond, Wash.) and Handspring Inc., (Mountain View, Calif.) and others. Such devices typically include a display screen for presenting visual information to a user and a writing surface for entry of data using a stylus. Data may also be entered using a keyboard coupled to the portable communicator or by means of a wired or wireless communication link. Some portable communicator models also include an audio transducer, or sound generator, adapted to produce sounds that are audible by a user. In one embodiment, data from IMD25or programmer45is displayed on a screen coupled to portable device35.

In one embodiment, portable device35is coupled to a portable telephone (such as a cellular telephone or a cordless telephone), a pager (one way or two way), or a computer (such as a handheld, palm-top, laptop, or notebook computer) or other such battery operated, processor based, portable communication device.

In one embodiment, portable device35, or portable communicator80, includes data storage and includes programming and instructions to conduct data processing. In one embodiment, the data storage capacity of portable device35or portable communicator80augments the data storage capacity of IMD25, thus enabling a clinician to access a greater amount of contextual information regarding the medical condition of a user. For example, but not by way of limitation, the contextual information may assist in discovering and understanding relationships among different events.

In one embodiment, a wireless receiver is coupled to portable device35for purposes of receiving data from IMD25. The wireless receiver may be internal or external to the housing of portable device35. In one embodiment, a wireless transmitter is coupled to portable device35for purposes of transmitting data to IMD25. The wireless transmitter may be internal or external to the housing of portable communicator80. In one embodiment, a wireless transceiver is coupled to portable device35for purposes of both transmitting data to, and receiving data from, IMD25. The wireless transceiver may be internal or external to the housing of portable device35. In one embodiment, portable device35includes a telemetry head that is positioned near IMD25to facilitate wireless communications.

In one embodiment, circuitry or programming allows portable device35to trigger an alarm under predetermined conditions. For example, portable device35may sound an audible alarm or transmit an alarm signal if a biometric parameter exceeds a particular value or is outside a specified range of values. The alarm signal can be received by programmer45or a designated physician.

Referring again toFIG. 1F, link40is shown to couple portable device35with programmer45. In one embodiment, link40includes a wired or wireless link that allows data communication between portable device35and programmer45. In one embodiment, data is exchanged between portable device35and programmer45by means of a removable storage media.

In one embodiment, programmer45includes a processor based apparatus executing programming to communicate with IMD25, portable device35, or both. Typically, a clinician or physician will operate programmer45to communicate with IMD25using portable device35as a data interface. In particular, one embodiment provides that data from IMD25can be retrieved by accessing the memory of portable device35. In one embodiment, programmer45transmits data to IMD25via portable device35.

FIG. 2illustrates, in block diagram form, an embodiment of present system10A. In the figure, IMD25A is coupled to programmer45A by wireless link30B and to portable device35A by wireless link30A. Programmer45A is further coupled to portable device35A by link40A and to network50by link40C. Portable device35A is further coupled to network50by link40B. Portable device35A receives data from involuntary data source58and exchanges data with user data source65. Link30A, link30B, link40A, link40B, link40C, and link70bear arrowheads on each end, and thus, are illustrated as bidirectional communication links. Nevertheless, it will be appreciated that some or all of the bidirectional communication links may be unidirectional. Furthermore, it will be appreciated that not all of the elements appearing inFIG. 2may be present in one embodiment of system10A.

To the extent that IMD25A, portable device35A, programmer45A, link30A, and link40A are described elsewhere in this document, the following discussion concerns the elements not earlier described.

IMD25A is coupled to programmer45A via wireless link30B. In one embodiment, link30B include a handheld wand that is placed in the vicinity of IMD25A to allow communication of data. In the figure, link30B is shown to include a bidirectional communication channel.

Portable device35A is coupled to programmer45A via network50by way of link40B and link40C. It will be appreciated that network50may include the Internet, a private intranet, a wide area network (WAN), a local area network (LAN), or other communication network. In one embodiment, programmer45A accesses network50using an ethernet connection, a dial-up connection, a cable modem connection, a digital subscriber line (DSL) connection, or other wired or wireless network connection. In one embodiment, portable device35A accesses network50using an ethernet connection, a dial-up connection, a cable modem connection, a digital subscriber line (DSL) connection, or other wired or wireless network connection.

Portable device35A is coupled to a block modeled in the figure as involuntary data source58. Involuntary data source58, in one embodiment, includes IMD25A and ex-IMD data source55, either of which can provide data to enable system10A to tailor therapy of IMD25in an efficient manner. As described above, IMD25A may include sensors that provide information, ultimately, to programmer45A. In addition, in one embodiment, ex-IMD data source55may include an externally worn sensor or an implanted device. In one embodiment, an implanted device includes a second implanted medical device adapted to monitor a body organ or function, such as a blood oxygen monitor. Also by way of example, one externally worn sensor include a non-invasive data source such as a temperature monitor, blood pressure monitor or respiration monitor. In one embodiment, ex-IMD data source55is non-user worn. For example, in one embodiment, data is provided by an ambient temperature monitor or atmospheric pressure monitor. In one embodiment, a plurality of ex-IMD data sources55are provided. Data sources other than those enumerated herein are also contemplated.

Data provided by ex-IMD data source55is coupled to portable device35A by link60. In one embodiment, link60includes a wired coupling and in another embodiment, a wireless coupling. In one embodiment, ex-IMD data source55is coupled to, and integrated with, portable device35A.

The data provided by ex-IMD data source55is received by portable device35A. In various embodiments, processing of the data is conducted by portable device35A or programmer45A. In one embodiment, the data is provided in real time, (either continuously or according to a predetermined schedule) or upon a change exceeding a predetermined amount, or upon request or inquiry from programmer45A or portable device35A.

Portable device35A is coupled to a block modeled in the figure as user data source65, by link70. In one embodiment, user data source65provides data volunteered by the user and is integrated with portable device35A. User data source65includes, in one embodiment, a display screen, an audio generator and an input device. In operation, portable device35A displays a question or prompt directed to the user and the user is instructed to respond by providing a manual input. For example, in one embodiment, portable device35A sounds a characteristic tone and display a question concerning the well-being of a user. The user, in response to the prompt, may use a stylus, keyboard, voice response, or other means to indicate a suitable answer to the question presented. The data received from the user prompt is then stored by portable device35A. In one embodiment, processing of the data received from user data source65is done by portable device35A or by programmer45A. User data source65may generate a prompt according to a predetermined schedule, randomly, or based on data received from portable device35A, IMD25or environmental data source55. In one embodiment, data is entered by the user on the user's initiative.

In one embodiment, programmer45A receives data from several data sources and communicated via any of several data communication channels. For example, programmer45A may receive data from IMD25A via link30B or via portable device35A by way of link30A and link40A. In addition, programmer45A may receive data from IMD25A via network50by way of link30A, link40B and link40C. Data may be acquired using an interrupt driven system or on a query-based system.

In addition, one embodiment provides that data from IMD25A is communicated to programmer45A via any of several communication paths. For example, data may be communicated to programmer45A using link40A,40B,40C,60or70.

FIG. 3illustrates a perspective view of an embodiment of the present subject matter. In the figure, portable communicator80includes a display screen80B, a plurality of user operable buttons80D, and expansion port80A. Expansion port80A receives, and electrically couples to, portable device35B. Stylus80C may be used to manually enter data using screen80B. Portable device35B is wirelessly coupled to implanted device25which, in the embodiment shown, is further coupled by electrode20to heart15.

Consider the operation of the embodiment inFIG. 3. Link30is illustrated as a bidirectional link and thus, data from device25is wirelessly telemetered to portable device35B. In addition, data, or programming from portable device35B is wirelessly telemetered to device25. At various times, portable communicator80will generate a prompt calling for a response in the form of a user input. A user may enter data using any of a variety of means. For example, a response may be entered using stylus80C, buttons80D, or an external keyboard. In one embodiment, portable communicator80responds to voice commands received from a user. A prompt may be visually displayed using screen80B or audibly generated using an internal sound generator. Manually entered data received from a user, as well as data received from other inputs (some of which were described relative toFIG. 2) is stored using portable communicator80. The data stored in portable communicator80is then available for processing, and to tailor the therapy. Data may be processed by portable communicator80, portable device35, or by programmer45.

In addition to data entry, in one embodiment, stylus80C, along with screen80B, and buttons80D, allow a user to exercise limited control over the operation of implantable medical device25. In one embodiment, reasonable constraints on the authority to change the operation of device25are established and implemented by a clinician using programmer45.

FIG. 4illustrates a perspective view of an embodiment of the present subject matter. In the figure, portable communicator80includes wireless communication antenna80E. Portable communicator80, in this embodiment, is adapted for wireless Internet access to network50A using link40B. In one embodiment, link40B includes a radio frequency communication link. In this embodiment, portable communicator80includes an internally mounted portable device35.

Programmer45accesses Internet50A via link40C. In one embodiment, link40C includes a dial-up modem connection, a cable modem connection, a DSL connection, an ISDN line, or other channel providing access to the Internet.

Using the system ofFIG. 4, a user may compile contextual information regarding ICD25, as well as himself, using portable communicator80. In one embodiment, a clinician using programmer45may remotely access the data stored in portable communicator80using link40C, Internet50A and link40B. In this manner, programmer45may wirelessly receive the data, process the data, and transmit data and code to change the future operation of device25.

FIG. 5illustrates a perspective view of an embodiment of the present subject matter. In the figure, portable communicator80includes portable device35and is coupled to IMD25, heart15and electrode20, by wireless link30. Portable communicator80is further coupled to programmer45by link40A and connector40D.

Using the system ofFIG. 5, a clinician operating programmer45is able to exchange data or code with portable communicator80using link40A. Connector40D is a multi-conductor connector providing access to data of portable communicator80. Portable device35is internal to portable communicator80. It will be appreciated that link40A may couple portable communicator80to a local area network or other communication network. For example, portable communicator80may be connected to a PSTN using link40A, and thus, programmer45may exchange data with portable communicator80using a modem coupled to PSTN.

FIG. 6Aillustrates a block diagram of an implanted medical device for one embodiment of the present system. In the figure, IMD25is shown to include processor100, memory105, update module110and transceiver115. In operation, processor100governs the operation of IMD25and executes programming stored in memory105. In addition to the executable program, memory105also includes data storage regarding the patient and IMD25. Update module110operates in conjunction with processor100, memory105and transceiver115to receive, install, and execute new instructions for execution by processor100.

FIG. 6Billustrates a block diagram of a portable device for one embodiment of the present system. In the figure portable device35is shown to include long term data storage120, input/output125, controller130, IMD transceiver135and communication interface140. Long term data storage120augments the data storage capacity of memory105of IMD25. In one embodiment, storage120is of a greater capacity than that of memory105. In addition, storage120may be of a physically larger size, be less expensive than medical grade implantable memory, and more robust.

Input/output125, IMD transceiver135and communication interface140, in conjunction with controller130enables receipt and transmission of data from IMD25as well as data from programmer45. IMD transceiver135and transceiver115provide a wireless telemetric link between IMD25and portable device35.

Portable device35may be coupled to a portable communicator and one or more of long term data120, input/output125, controller130, IMD transceiver135, or communication interface140may be provided by the portable communicator.

FIG. 7illustrates in block diagram, an embodiment of the present subject matter. In one embodiment, CRM therapy, for CHF is provided to heart15by IMD25via lead20. Data accessible to IMD25is wirelessly communicated to portable device35via link30C. Portable device35operates as a data storage facility for IMD25and in one embodiment, performs data processing.

Programmer45receives data from portable device35via link40E. In one embodiment, programmer45performs data processing. Updated programming for execution by IMD25is determined by programmer45and transmitted wirelessly to IMD25via link30D. Updated programming may be based on data received from portable device35, as well as manual inputs received at programmer45. IMD25includes a transmitter to communicate using link30C and a receiver to communicate using link30D.

In the embodiment illustrated inFIG. 7, portable device35provides a communication link for data communicated from IMD25to programmer45. It will be understood that other data may also be received, processed and stored by portable device35as well as programmer45. For example, a non-invasive data source may provide data to portable device35.

FIG. 8illustrates in block diagram, an embodiment of the present subject matter. In the figure, CRM therapy is provided to heart15by IMD25via lead20. In the embodiment shown, IMD25includes a wireless receiver that receives transmissions from portable device35via link30E. In addition, portable device35also receives data from non-invasive data source55A via link60A. Link60A may include a wired or wireless link. Data accessible to portable device35is communicated to programmer45via link40F. Link40F may be a wired or wireless link. Portable device35operates as a data storage facility for non-invasive data source55A and in one embodiment, performs data processing. In one embodiment, programmer45performs data processing. Updated programming for execution by IMD25is determined by programmer45and communicated to portable device35by link40F. Updated programming is transmitted wirelessly to IMD25via link30E. Updated programming may be based on data received from portable device35, as well as manual inputs received at programmer45. IMD25includes a receiver to communicate using link30E.

In the embodiment illustrated inFIG. 8, portable device35provides a communication link for data communicated from programmer45to IMD25. As illustrated, non-invasive data, or other environmental data, may also be received, processed and stored by portable device35as well as programmer45.

FIG. 9illustrates in block diagram, an embodiment of the present subject matter. In the figure, CRM therapy is provided to heart15by IMD25via lead20. Data source55B communicates with portable device35via link60B. Portable device35operates as a data storage facility for data source55B and in one embodiment, performs data processing. Programmer45receives data from portable device35via link40E. In one embodiment, programmer45performs data processing. Data and updated programming for execution by IMD25is determined by programmer45and transmitted wirelessly to IMD25via link30D. Updated programming may be based on data received from portable device35, as well as manual inputs received at programmer45. IMD25includes a wireless receiver to communicate using link30D.

In the embodiment illustrated inFIG. 9, it will be understood that other data may also be received, processed and stored by portable device35as well as programmer45. For example, a non-invasive data source or user entered data may provide data to portable device35.

FIG. 10illustrates a portion of an embodiment of the present subject matter. In the figure, IMD25is in wireless communication with portable device35. Arrow30C illustrates the direction of data communication from IMD25to portable device35. In one embodiment, data from IMD25includes, but is not limited to, operational data concerning the performance of IMD25, diagnostic data concerning either IMD25or the patient, as well as patient medical information. Arrow30E illustrates the direction of data and program information from portable device35to IMD25. In one embodiment, data and program information from portable device35includes, but is not limited to, updated operating code, operational parameters, instructions, and executable code.

FIG. 11illustrates, in block diagram form, user input data implemented in one embodiment of the present system. It will be appreciated that more or less than the illustrated data may be implemented in an embodiment. The user input data may be received from a user based on a prompt provided to the user, on an ad hoc basis as determined by the user, or as determined by a processor of the present system. The user may enter data using a menu based system, a graphical user interface (GUI), textual data or numerical data.FIG. 2illustrates an embodiment of the present system having user data source65providing user input data.

At155, the input data includes a sleep schedule. The sleep schedule may describe the sleep (or wake) times of the user. The user may enter the data into portable device35. In an embodiment including portable device35coupled to portable communicator80, the data may be entered, for example, using stylus80C, keys80D or a keyboard. At160, the input data includes a user-selected quality of life index. The user may select and specify a suitable response based on subjective or objective criteria. At165, the input data includes an entry corresponding to the user's physical strength. At170, the input data includes an entry corresponding to the mental acuity of the user. In this instance, portable communicator80may determine a value based on predetermined criteria which may entail analysis of a series of user entered responses. At175, the input data includes information concerning the recent dietary intake of the user. Data may include caloric content, nutritional content (sodium levels), quantity and type of foods. At180, the input data may include user provided data concerning voiding patterns or behavior. At190, the input data may include drug intake or medicine compliance information. At195, the input data may include alcohol consumption information such as quantity, type and time of intake. At200, the input data may include transient illness information concerning such matters as time of onset, symptoms, treatment and recovery. At205, the input data may include miscellaneous predictive input information. For example, the user may enter data to indicate that he will soon be walking or running or otherwise exercising. Other input data may also be provided depending upon the circumstances of the patient. The user input information may be tailored by the treating physician using programmer45and portable device35. For example, the data collection protocol may be tailored to reduce battery consumption by prompting the user for a response at a reduced frequency.

FIG. 12illustrates, in block diagram form, a selection of external, or non-invasive, devices210that may be implemented in one embodiment of the present system. It will be appreciated that more or less than the illustrated devices may be implemented in an embodiment. External devices210provide environmental data that may be received by portable device35of the present system. Data may be generated by external devices210and provided, in digital form, to portable device35by a wired or wireless link.FIG. 2illustrates an embodiment of the present system having environmental data source55including external device data sources.

At215, the external device includes a blood pressure monitor. Encoded blood pressure information for the patient is provided as a function of time or other measured parameter. At220, the external device includes an objective measure of the patient's quality of life. In one embodiment, this may entail a sensor adapted to correlate with quality of life. At225, the external device includes a temperature monitor. Encoded temperature information is provided as a function of time or other measured parameter. The measured temperature may correspond to a body temperature, an ambient temperature, or other temperature. At230, an external device provides data concerning the sleep time of the patient. The device may include a monitor coupled to a clock or a monitor coupled to another device corresponding to sleep time and sleep phase variation.

FIG. 13illustrates, in block diagram form, a selection of implantable devices235that may be implemented in one embodiment of the present system. It will be appreciated that more or less than the illustrated devices may be implemented in an embodiment. Implantable devices235provide internal data that may be received by portable device35of the present system. Such data may be generated and provided, in digital form, to portable device35by a wired or wireless link. The implantable devices each provide a signal that is encoded and wirelessly communicated to portable device35.FIG. 2illustrates an embodiment of the present system having environmental data source55including implantable devices providing data.

At240, the implantable device includes a heart rhythm monitor. At245, the implantable device includes a respiration monitor. At250, the implantable device includes an activity monitor. At255, the implantable device includes a contractility measurement device.

FIG. 14illustrates a method for analysis of trends using one embodiment of the present system. In one embodiment, method260is implemented by software or hardware using portable device35or other elements of system10. At265, data is acquired from various sources. Referring toFIG. 2, data may be acquired from IMD25, programmer45, network50, environmental data source55and user data source65. At270, the acquired data is processed according to a procedure implemented in software. The procedure entails analysis of the data as a function of time or other measured parameter. At275, the results of the data analysis are used to select an updated program or specify updated operational parameters for IMD25. At280, the updated program or operational parameters are transferred and implemented by IMD25.

In one embodiment, a security protocol is implemented. The security protocol may assure authorized access for communications between programmer45and the portable device35. In addition, one embodiment provides secure communications between portable device35and IMD25. Authorization may be limited to reading data or reading and editing data. Security may entail a password and username system, encryption, or other biometric authentication system to prevent unauthorized access.

The present system provides data that may be useful in trend analysis, and thus, improve health care for a patient. For example, the present system may allow monitoring of device performance over an extended duration. Long term device performance data may facilitate improved therapy. In addition, the present system may allow cost-effective compilation of patient medical data. Such historical data may prove beneficial in developing treatment protocols for the patient.

Although the invention has been described in conjunction with the foregoing specific embodiments, many alternatives, variations, and modifications will be apparent to those of ordinary skill in the art. Other such alternatives, variations, and modifications are intended to fall within the scope of the following appended claims.