Optimizing implanted medical device performance

<u>Technical Field</u>

0001The 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.

<u>Background</u>

0002A 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.

0003Unhealthy 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.

0004Typically, 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.

0005In 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.

0006A 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.

0007The 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.

0008Consumer, 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.

0009At 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.

0010<patcit id="pcit0001" dnum="US20010051787A1"><text>U.S. 2001/0051787 A1</text></patcit> discloses methods, devices and systems for automatically generating invoices when medical services are provided to a patient. An implantable medical device (IMD) is capable of bi-directional communication with a communication module, a mobile telephone and/or a Personal Data Assistant (PDA) located outside the patient's body. The invoicing system may comprise the IMD, the communication module and/or a mobile telephone and/or a PDA, means for generating an invoice, a remote computer system, and a communication system capable of bi-directional communication, where the communication module, the mobile telephone and/or the PDA is capable of receiving information from the IMD or relaying information thereto.

0011<patcit id="pcit0002" dnum="US20020077562A1"><text>U.S. 2002/0077562 A1</text></patcit> discloses a system and method for correlating health related data for display. The system includes a medical device recording data and a display producing device which correlates the data and simultaneously displays different types of data or displays two sets of the same type of data along with the circumstances at which the two sets of data were recorded.

Summary

0012The present subject matter includes, among other things, a system and method as claimed in claims 1 and 17 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.

0013By 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.

0014At 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.

0015In 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.

0016In 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.

0017In 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.

0018In 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.

0019In 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.

0020The 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.

0021The 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.

<u>Brief Description of the Figures</u>

0022<ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Figure 1A</figref> illustrates a patient with an implanted medical device holding a portable communicator as well as a screen shot of the portable communicator.</li><li><figref idref="f0002">Figure 1B, 1C, 1D, 1E</figref> illustrate screen shots appearing on a portable communicator according to one embodiment.</li><li><figref idref="f0003">Figure 1F</figref> illustrates a block diagram of an embodiment of the present system having a implantable medical device, a portable device, and a programmer.</li><li><figref idref="f0004">Figure 2</figref> illustrates a block diagram illustrating communication channels between involuntary data sources, a portable device, a programmer, a network, and a user data source.</li><li><figref idref="f0005">Figure 3</figref> illustrates a perspective view of a PDA with a removable portable device, in communication with an implantable cardiac device coupled to a heart.</li><li><figref idref="f0006">Figure 4</figref> illustrates a system according to the present subject matter including a PDA wirelessly coupled to an implantable cardiac device and wirelessly coupled to the Internet and further coupled to a remote programmer.</li><li><figref idref="f0007">Figure 5</figref> illustrates a system according to the present subject matter including a PDA wirelessly coupled to an implantable cardiac device and coupled to a programmer via a wired connection.</li><li><figref idref="f0008">Figure 6A</figref> illustrates a block diagram of an implantable medical device for one embodiment of the present system.</li><li><figref idref="f0008">Figure 6B</figref> illustrates a block diagram of a portable device for one embodiment of the present system.</li><li><figref idref="f0009">Figure 7</figref> illustrates one embodiment of the present subject matter having an implantable medical device communicating data to a portable device which, in turn, communicates with a programmer and the programmer is coupled to the implantable medical device.</li><li><figref idref="f0009">Figure 8</figref> illustrates one embodiment of the present system including an implantable medical device receiving data from a non-invasive data source provided to a portable device, and further communicating with a programmer.</li><li><figref idref="f0009">Figure 9</figref> illustrates one embodiment of the present system including a data source that provides data to a portable communicator which is coupled to a programmer which communicates with an implantable medical device.</li><li><figref idref="f0010">Figure 10</figref> illustrates, in block diagram, communication paths between an implantable medical device and a portable device.</li><li><figref idref="f0010">Figure 11</figref> illustrates selected types of user input data.</li><li><figref idref="f0011">Figure 12</figref> illustrates selected types of external devices.</li><li><figref idref="f0011">Figure 13</figref> illustrates selected types of implantable devices.</li><li><figref idref="f0012">Figure 14</figref> illustrates an algorithm executed by one embodiment of the present subject matter.</li></ul>

<u>Detailed Description</u>

0023In the following detailed description, reference is made to the accompanying drawings which form a part hereof, and in which is shown by way of illustration specific embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is to be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural, logical and electrical changes may be made without departing from the spirit and scope of the present invention. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims and their equivalents. In the drawings, like numerals describe substantially similar components throughout the several views. Like numerals having different letter suffixes represent different instances of substantially similar components. As used herein, the term data includes both data and programming.

0024In accordance with the present system, <figref idref="f0001">Figure 1A</figref> illustrates patient 455 implanted with implantable medical device 25 coupled to heart 15A by leads 20A and 20B. In one embodiment, the combination of leads 20A and 20B and device 25 provides cardiac rhythm management pulsing and also senses one or more physiological parameters of heart 15A. Implantable medical device 25 communicates wirelessly with portable device 35 shown in the left hand of patient 455. Portable device 35 is external to the body of patient 455 and, in the embodiment shown, is coupled to portable communicator 80. In one embodiment, portable communicator 80 includes a PDA.

0025In one embodiment, implantable medical device 25 provides data including heart rhythm, breathing, activity, and contractility, as illustrated at 450. Other types of data derived from implantable systems are also contemplated, as noted at 450. For example, in one embodiment, a respiration sensor is implanted into patient 455 and communicates with portable device 35. 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.

0026In one embodiment, portable communicator 80 includes a touch-sensitive display screen for displaying information to a user or patient 455. Depending on the application executing on portable communicator 80, the display screen may provide prompts, messages, questions, or other data designed to elicit an input from patient 455. For example, in one embodiment, portable communicator 80 may display a screen shot as shown at 400. Screen shot 400, 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 of 405 through 445, the patient may be linked to one or more questions concerning the general topic appearing in screen shot 400. For example, at 405, the link "Blood Pressure" may lead to one or more questions concerning the patient's blood pressure. At 410, the patient may be prompted for information concerning their body weight. At 415 the patient may be prompted to supply data concerning their sleep patterns (bedtime, sleep time, perceived arousals, perceived sleep quality) or recent life experiences. At 420, the patient may be prompted for data concerning their perceived quality of life (Q of L). At 425, the patient may be prompted to supply information concerning their perceived physical strength. At 430, 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 communicator 80 calculates a parameter corresponding to mental acuity. At 435, the patient is prompted for data concerning their dietary intake. At 440, the patient is prompted for data concerning their voiding patterns. At 445, the patient is prompted to supply information concerning drug therapy compliance.

0027Wellness monitoring system 460 is in communication with portable communicator 80, and thus, portable device 35. Wellness monitoring system 460 provides analysis of voluntary and involuntary data gathered by portable device 35. In one embodiment, wellness monitoring system 460 includes computer and programming that conducts data analysis and identifies trends that may improve patient health and medical care.

0028<figref idref="f0002">Figure 1B</figref> illustrates a screen shot of questions that may be posed in one embodiment. Questions and prompts appearing on a display coupled to portable device 35 may 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.

0029<figref idref="f0002">Figure 1C</figref> illustrates 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.

0030<figref idref="f0002">Figure 1D</figref> illustrates a screen shot of questions directed to eating a balanced diet, lethargy, insomnia, voiding patterns, and drug and dietary supplement intake.

0031<figref idref="f0002">Figure 1E</figref> illustrates 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).

0032<figref idref="f0003">Figure 1F</figref> illustrates, in block diagram form, an embodiment of the present system. In the figure, system 10 is shown to include an implantable medical device, here marked IMD 25, which is shown coupled, by lead 20, to heart 15. In one embodiment, IMD 25 includes 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, IMD 25 is further shown coupled to portable device 35 by link 30. In one embodiment, portable device 35 includes a portable communicator. Portable device 35 is further coupled to programmer 45 by link 40.

0033In one embodiment, lead 20 includes 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, lead 20 is coupled to a human or animal heart, however, other organs may also be monitored or treated. In one embodiment, the housing of IMD 25 is electrically conductive and serves as an electrical conductor and operates in conjunction with a signal on a conductor portion of lead 20.

0034In one embodiment, IMD 25 includes 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, IMD 25 also includes circuitry and programming adapted to monitor the condition and performance of the pulse generator or other implanted device. For example, in one embodiment, IMD 25 provides data concerning the remaining battery condition for a power supply coupled to IMD 25. 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 IMD 25. 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, IMD 25 is controlled by digital or analog signals and in one embodiment, IMD 25 generates data in digital or analog form.

0035In one embodiment, IMD 25 includes 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 IMD 25 to be dynamically tailored to a particular patient or condition. In one embodiment, the operating system, or memory contents of IMD 25 can be changed using wireless communication.

0036In one embodiment, IMD 25 includes 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 IMD 25 and another transceiver. In one embodiment, IMD 25 is coupled to a wireless transceiver by a wired connection.

0037In one embodiment, IMD 25 performs a data acquisition function. For example, a detector coupled to IMD 25 is 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 IMD 25 may be adapted to store a comparison value which may then be compared with a measured value thereby determining the performance of IMD 25 or the health of the patient.

0038Link 30 is a wireless communication link between IMD 25 and portable device 35. Link 30 allows communication in one or two directions. For example, in one embodiment, data from IMD 25 is communicated to portable device 35 with no data transmitted from portable device 35 to IMD 25. In this manner, portable device 35 functions as a data storage facility for IMD 25. In one embodiment, data stored in portable device 35 can be accessed by a treating physician and used for diagnosis, therapy or other purposes. Programming and controlling the operation of IMD 25 is performed using a programmer adapted to transmit commands, data or code to IMD 25. In one embodiment, portable device 35, or portable communicator 80, executes programming to analyze and process the data received from IMD 25. In one embodiment, communication link 30 may preclude transfer of data from portable device 35 to IMD 25 or to preclude transfer of data from IMD 25 to portable device 35. For example, in one embodiment, portable device 35 executes programming which automatically adjusts the performance or operation of IMD 25 independent of programmer 45 and under certain predetermined conditions, it may be desirable to preclude such automatic adjustments.

0039In one embodiment, data is communicated from portable device 35 to IMD 25 with no data transmitted from IMD 25 to portable device 35. In this manner, portable device 35 functions as an interface to communicate commands, data or code to IMD 25.

0040In one embodiment, data is communicated bidirectionally between IMD 25 and portable device 35. In various embodiments, link 30 entails 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, link 30 include a wireless radio frequency link compatible with a transmitter and receiver that uses frequency hopping, spread spectrum technology.

0041In one embodiment, internal memory within IMD 25 provides storage for data related to the CRM therapy provided to heart 15. The data may relate to the electrical, chemical or mechanical operation of the heart. In addition, IMD 25 includes memory for programming, comparison and other functions. In one embodiment, the contents of the memory regulates the operation of IMD 25.

0042In one embodiment, portable device 35 is 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, California), Microsoft Corporation (Redmond, Washington) and Handspring Inc., (Mountain View, California) 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 IMD 25 or programmer 45 is displayed on a screen coupled to portable device 35.

0043In one embodiment, portable device 35 is 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.

0044In one embodiment, portable device 35, or portable communicator 80, includes data storage and includes programming and instructions to conduct data processing. In one embodiment, the data storage capacity of portable device 35 or portable communicator 80 augments the data storage capacity of IMD 25, 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.

0045In one embodiment, a wireless receiver is coupled to portable device 35 for purposes of receiving data from IMD 25. The wireless receiver may be internal or external to the housing of portable device 35. In one embodiment, a wireless transmitter is coupled to portable device 35 for purposes of transmitting data to IMD 25. The wireless transmitter may be internal or external to the housing of portable communicator 80. In one embodiment, a wireless transceiver is coupled to portable device 35 for purposes of both transmitting data to, and receiving data from, IMD 25. The wireless transceiver may be internal or external to the housing of portable device 35. In one embodiment, portable device 35 includes a telemetry head that is positioned near IMD 25 to facilitate wireless communications.

0046In one embodiment, circuitry or programming allows portable device 35 to trigger an alarm under predetermined conditions. For example, portable device 35 may 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 programmer 45 or a designated physician.

0047Referring again to <figref idref="f0003">Figure 1F</figref>, link 40 is shown to couple portable device 35 with programmer 45. In one embodiment, link 40 includes a wired or wireless link that allows data communication between portable device 35 and programmer 45. In one embodiment, data is exchanged between portable device 35 and programmer 45 by means of a removable storage media.

0048In one embodiment, programmer 45 includes a processor based apparatus executing programming to communicate with IMD 25, portable device 35, or both. Typically, a clinician or physician will operate programmer 45 to communicate with IMD 25 using portable device 35 as a data interface. In particular, one embodiment provides that data from IMD 25 can be retrieved by accessing the memory of portable device 35. In one embodiment, programmer 45 transmits data to IMD 25 via portable device 35.

0049<figref idref="f0004">Figure 2</figref> illustrates, in block diagram form, an embodiment of present system 10A. In the figure, IMD 25A is coupled to programmer 45A by wireless link 30B and to portable device 35A by wireless link 30A. Programmer 45A is further coupled to portable device 35A by link 40A and to network 50 by link 40C. Portable device 35A is further coupled to network 50 by link 40B. Portable device 35A receives data from involuntary data source 58 and exchanges data with user data source 65. Link 30A, link 30B, link 40A, link 40B, link 40C, and link 70 bear 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 in <figref idref="f0004">Figure 2</figref> may be present in one embodiment of system 10A.

0050To the extent that IMD 25A, portable device 35A, programmer 45A, link 30A, and link 40A are described elsewhere in this document, the following discussion concerns the elements not earlier described.

0051IMD 25A is coupled to programmer 45A via wireless link 30B. In one embodiment, link 30B include a handheld wand that is placed in the vicinity of IMD 25A to allow communication of data. In the figure, link 30B is shown to include a bidirectional communication channel.

0052Portable device 35A is coupled to programmer 45A via network 50 by way of link 40B and link 40C. It will be appreciated that network 50 may include the Internet, a private intranet, a wide area network (WAN), a local area network (LAN), or other communication network. In one embodiment, programmer 45A accesses network 50 using 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 device 35A accesses network 50 using an ethernet connection, a dial-up connection, a cable modem connection, a digital subscriber line (DSL) connection, or other wired or wireless network connection.

0053Portable device 35A is coupled to a block modeled in the figure as involuntary data source 58. Involuntary data source 58, in one embodiment, includes IMD 25A and ex-IMD data source 55, either of which can provide data to enable system 10A to tailor therapy of IMD 25 in an efficient manner. As described above, IMD 25A may include sensors that provide information, ultimately, to programmer 45A. In addition, in one embodiment, ex-IMD data source 55 may 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 source 55 is 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 sources 55 are provided. Data sources other than those enumerated herein are also contemplated.

0054Data provided by ex-IMD data source 55 is coupled to portable device 35A by link 60. In one embodiment, link 60 includes a wired coupling and in another embodiment, a wireless coupling. In one embodiment, ex-IMD data source 55 is coupled to, and integrated with, portable device 35A.

0055The data provided by ex-IMD data source 55 is received by portable device 35A. In various embodiments, processing of the data is conducted by portable device 35A or programmer 45A. 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 programmer 45A or portable device 35A.

0056Portable device 35A is coupled to a block modeled in the figure as user data source 65, by link 70. In one embodiment, user data source 65 provides data volunteered by the user and is integrated with portable device 35A. User data source 65 includes, in one embodiment, a display screen, an audio generator and an input device. In operation, portable device 35A 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 device 35A 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 device 35A. In one embodiment, processing of the data received from user data source 65 is done by portable device 35A or by programmer 45A. User data source 65 may generate a prompt according to a predetermined schedule, randomly, or based on data received from portable device 35A, IMD 25 or environmental data source 55. In one embodiment, data is entered by the user on the user's initiative.

0057In one embodiment, programmer 45A receives data from several data sources and communicated via any of several data communication channels. For example, programmer 45A may receive data from IMD 25A via link 30B or via portable device 35A by way of link 30A and link 40A. In addition, programmer 45A may receive data from IMD 25A via network 50 by way of link 30A, link 40B and link 40C. Data may be acquired using an interrupt driven system or on a query-based system.

0058In addition, one embodiment provides that data from IMD 25A is communicated to programmer 45A via any of several communication paths. For example, data may be communicated to programmer 45A using link 40A, 40B, 40C, 60 or 70.

0059<figref idref="f0005">Figure 3</figref> illustrates a perspective view of an embodiment of the present subject matter. In the figure, portable communicator 80 includes a display screen 80B, a plurality of user operable buttons 80D, and expansion port 80A. Expansion port 80A receives, and electrically couples to, portable device 35B. Stylus 80C may be used to manually enter data using screen 80B. Portable device 35B is wirelessly coupled to implanted device 25 which, in the embodiment shown, is further coupled by electrode 20 to heart 15.

0060Consider the operation of the embodiment in <figref idref="f0005">Figure 3</figref>. Link 30 is illustrated as a bidirectional link and thus, data from device 25 is wirelessly telemetered to portable device 35B. In addition, data, or programming from portable device 35B is wirelessly telemetered to device 25. At various times, portable communicator 80 will 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 stylus 80C, buttons 80D, or an external keyboard. In one embodiment, portable communicator 80 responds to voice commands received from a user. A prompt may be visually displayed using screen 80B 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 to <figref idref="f0004">Figure 2</figref>) is stored using portable communicator 80. The data stored in portable communicator 80 is then available for processing, and to tailor the therapy. Data may be processed by portable communicator 80, portable device 35, or by programmer 45.

0061In addition to data entry, in one embodiment, stylus 80C, along with screen 80B, and buttons 80D, allow a user to exercise limited control over the operation of implantable medical device 25. In one embodiment, reasonable constraints on the authority to change the operation of device 25 are established and implemented by a clinician using programmer 45.

0062<figref idref="f0006">Figure 4</figref> illustrates a perspective view of an embodiment of the present subject matter. In the figure, portable communicator 80 includes wireless communication antenna 80E. Portable communicator 80, in this embodiment, is adapted for wireless Internet access to network 50A using link 40B. In one embodiment, link 40B includes a radio frequency communication link. In this embodiment, portable communicator 80 includes an internally mounted portable device 35.

0063Programmer 45 accesses Internet 50A via link 40C. In one embodiment, link 40C includes a dial-up modem connection, a cable modem connection, a DSL connection, an ISDN line, or other channel providing access to the Internet.

0064Using the system of <figref idref="f0006">Figure 4</figref>, a user may compile contextual information regarding ICD 25, as well as himself, using portable communicator 80. In one embodiment, a clinician using programmer 45 may remotely access the data stored in portable communicator 80 using link 40C, Internet 50A and link 40B. In this manner, programmer 45 may wirelessly receive the data, process the data, and transmit data and code to change the future operation of device 25.

0065<figref idref="f0007">Figure 5</figref> illustrates a perspective view of an embodiment of the present subject matter. In the figure, portable communicator 80 includes portable device 35 and is coupled to IMD 25, heart 15 and electrode 20, by wireless link 30. Portable communicator 80 is further coupled to programmer 45 by link 40A and connector 40D.

0066Using the system of <figref idref="f0007">Figure 5</figref>, a clinician operating programmer 45 is able to exchange data or code with portable communicator 80 using link 40A. Connector 40D is a multi-conductor connector providing access to data of portable communicator 80. Portable device 35 is internal to portable communicator 80. It will be appreciated that link 40A may couple portable communicator 80 to a local area network or other communication network. For example, portable communicator 80 may be connected to a PSTN using link 40A, and thus, programmer 45 may exchange data with portable communicator 80 using a modem coupled to PSTN.

0067<figref idref="f0008">Figure 6A</figref> illustrates a block diagram of an implanted medical device for one embodiment of the present system. In the figure, IMD 25 is shown to include processor 100, memory 105, update module 110 and transceiver 115. In operation, processor 100 governs the operation of IMD 25 and executes programming stored in memory 105. In addition to the executable program, memory 105 also includes data storage regarding the patient and IMD 25. Update module 110 operates in conjunction with processor 100, memory 105 and transceiver 115 to receive, install, and execute new instructions for execution by processor 100.

0068<figref idref="f0008">Figure 6B</figref> illustrates a block diagram of a portable device for one embodiment of the present system. In the figure portable device 35 is shown to include long term data storage 120, input/output 125, controller 130, IMD transceiver 135 and communication interface 140. Long term data storage 120 augments the data storage capacity of memory 105 of IMD 25. In one embodiment, storage 120 is of a greater capacity than that of memory 105. In addition, storage 120 may be of a physically larger size, be less expensive than medical grade implantable memory, and more robust.

0069Input/output 125, IMD transceiver 135 and communication interface 140, in conjunction with controller 130 enables receipt and transmission of data from IMD 25 as well as data from programmer 45. IMD transceiver 135 and transceiver 115 provide a wireless telemetric link between IMD 25 and portable device 35.

0070Portable device 35 may be coupled to a portable communicator and one or more of long term data 120, input/output 125, controller 130, IMD transceiver 135, or communication interface 140 may be provided by the portable communicator.

0071<figref idref="f0009">Figure 7</figref> illustrates in block diagram, an embodiment of the present subject matter. In one embodiment, CRM therapy, for CHF is provided to heart 15 by IMD 25 via lead 20. Data accessible to IMD 25 is wirelessly communicated to portable device 35 via link 30C. Portable device 35 operates as a data storage facility for IMD 25 and in one embodiment, performs data processing.

0072Programmer 45 receives data from portable device 35 via link 40E. In one embodiment, programmer 45 performs data processing. Updated programming for execution by IMD 25 is determined by programmer 45 and transmitted wirelessly to IMD 25 via link 30D. Updated programming may be based on data received from portable device 35, as well as manual inputs received at programmer 45. IMD 25 includes a transmitter to communicate using link 30C and a receiver to communicate using link 30D.

0073In the embodiment illustrated in <figref idref="f0009">Figure 7</figref>, portable device 35 provides a communication link for data communicated from IMD 25 to programmer 45. It will be understood that other data may also be received, processed and stored by portable device 35 as well as programmer 45. For example, a non-invasive data source may provide data to portable device 35.

0074<figref idref="f0009">Figure 8</figref> illustrates in block diagram, an embodiment of the present subject matter. In the figure, CRM therapy is provided to heart 15 by IMD 25 via lead 20. In the embodiment shown, IMD 25 includes a wireless receiver that receives transmissions from portable device 35 via link 30E. In addition, portable device 35 also receives data from non-invasive data source 55A via link 60A. Link 60A may include a wired or wireless link. Data accessible to portable device 35 is communicated to programmer 45 via link 40F. Link 40F may be a wired or wireless link. Portable device 35 operates as a data storage facility for non-invasive data source 55A and in one embodiment, performs data processing. In one embodiment, programmer 45 performs data processing. Updated programming for execution by IMD 25 is determined by programmer 45 and communicated to portable device 35 by link 40F. Updated programming is transmitted wirelessly to IMD 25 via link 30E. Updated programming may be based on data received from portable device 35, as well as manual inputs received at programmer 45. IMD 25 includes a receiver to communicate using link 30E.

0075In the embodiment illustrated in <figref idref="f0009">Figure 8</figref>, portable device 35 provides a communication link for data communicated from programmer 45 to IMD 25. As illustrated, non-invasive data, or other environmental data, may also be received, processed and stored by portable device 35 as well as programmer 45.

0076<figref idref="f0009">Figure 9</figref> illustrates in block diagram, an embodiment of the present subject matter. In the figure, CRM therapy is provided to heart 15 by IMD 25 via lead 20. Data source 55B communicates with portable device 35 via link 60B. Portable device 35 operates as a data storage facility for data source 55B and in one embodiment, performs data processing. Programmer 45 receives data from portable device 35 via link 40E. In one embodiment, programmer 45 performs data processing. Data and updated programming for execution by IMD 25 is determined by programmer 45 and transmitted wirelessly to IMD 25 via link 30D. Updated programming may be based on data received from portable device 35, as well as manual inputs received at programmer 45. IMD 25 includes a wireless receiver to communicate using link 30D.

0077In the embodiment illustrated in <figref idref="f0009">Figure 9</figref>, it will be understood that other data may also be received, processed and stored by portable device 35 as well as programmer 45. For example, a non-invasive data source or user entered data may provide data to portable device 35.

0078<figref idref="f0010">Figure 10</figref> illustrates a portion of an embodiment of the present subject matter. In the figure, IMD 25 is in wireless communication with portable device 35. Arrow 30C illustrates the direction of data communication from IMD 25 to portable device 35. In one embodiment, data from IMD 25 includes, but is not limited to, operational data concerning the performance of IMD 25, diagnostic data concerning either IMD 25 or the patient, as well as patient medical information. Arrow 30E illustrates the direction of data and program information from portable device 35 to IMD 25. In one embodiment, data and program information from portable device 35 includes, but is not limited to, updated operating code, operational parameters, instructions, and executable code.

0079<figref idref="f0010">Figure 11</figref> illustrates, 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 <i>ad hoc</i> 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. <figref idref="f0004">Figure 2</figref> illustrates an embodiment of the present system having user data source 65 providing user input data.

0080At 155, 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 device 35. In an embodiment including portable device 35 coupled to portable communicator 80, the data may be entered, for example, using stylus 80C, keys 80D or a keyboard. At 160, 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. At 165, the input data includes an entry corresponding to the user's physical strength. At 170, the input data includes an entry corresponding to the mental acuity of the user. In this instance, portable communicator 80 may determine a value based on predetermined criteria which may entail analysis of a series of user entered responses. At 175, 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. At 180, the input data may include user provided data concerning voiding patterns or behavior. At 190, the input data may include drug intake or medicine compliance information. At 195, the input data may include alcohol consumption information such as quantity, type and time of intake. At 200, the input data may include transient illness information concerning such matters as time of onset, symptoms, treatment and recovery. At 205, 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 programmer 45 and portable device 35. For example, the data collection protocol may be tailored to reduce battery consumption by prompting the user for a response at a reduced frequency.

0081<figref idref="f0011">Figure 12</figref> illustrates, in block diagram form, a selection of external, or non-invasive, devices 210 that 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 devices 210 provide environmental data that may be received by portable device 35 of the present system. Data may be generated by external devices 210 and provided, in digital form, to portable device 35 by a wired or wireless link. <figref idref="f0004">Figure 2</figref> illustrates an embodiment of the present system having environmental data source 55 including external device data sources.

0082At 215, 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. At 220, 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. At 225, 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. At 230, 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.

0083<figref idref="f0011">Figure 13</figref> illustrates, in block diagram form, a selection of implantable devices 235 that 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 devices 235 provide internal data that may be received by portable device 35 of the present system. Such data may be generated and provided, in digital form, to portable device 35 by a wired or wireless link. The implantable devices each provide a signal that is encoded and wirelessly communicated to portable device 35. <figref idref="f0004">Figure 2</figref> illustrates an embodiment of the present system having environmental data source 55 including implantable devices providing data.

0084At 240, the implantable device includes a heart rhythm monitor. At 245, the implantable device includes a respiration monitor. At 250, the implantable device includes an activity monitor. At 255, the implantable device includes a contractility measurement device.

0085<figref idref="f0012">Figure 14</figref> illustrates a method for analysis of trends using one embodiment of the present system. In one embodiment, method 260 is implemented by software or hardware using portable device 35 or other elements of system 10. At 265, data is acquired from various sources. Referring to <figref idref="f0004">Figure 2</figref>, data may be acquired from IMD 25, programmer 45, network 50, environmental data source 55 and user data source 65. At 270, 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. At 275, the results of the data analysis are used to select an updated program or specify updated operational parameters for IMD 25. At 280, the updated program or operational parameters are transferred and implemented by IMD 25.

0086In one embodiment, a security protocol is implemented. The security protocol may assure authorized access for communications between programmer 45 and the portable device 35. In addition, one embodiment provides secure communications between portable device 35 and IMD 25. 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.

0087The 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.

0088Although 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.